State California Regulations TITLE 17. PUBLIC HEALTH DIVISION 1. STATE DEPARTMENT OF HEALTH SERVICES database is current through 09/29/06, Register 2006, No. 39 Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Chapter 1252, Statutes of 1977. s 100. Eligibility Requirements. (a) Hospital districts may apply for State loans to pay for medical injury tort claims or judgments that are in excess of $300,000. Such hospital districts shall meet all of the following: (1) Be the Chowchilla Memorial Hospital District, or a hospital district which has entered into a joint powers agreement with the Chowchilla Memorial Hospital District. (2) Be located in a county that has areas that are designated as rural medically undeserved areas by the Health Manpower Policy Commission, pursuant to Section 1188.4, Chapter 4, Part 4, Health and Safety Code (Rural Health Services, October 1976). (3) Have a licensed bed capacity of less than 100 beds. (4) Have submitted to the Department on or before September 8, 1977, a statement which includes the following: (A) A utilization review plan or its equivalent which has been officially adopted by the governing body of the hospital districts and which: 1. Provides for the participation of the entire medical staff in a review committee. 2. Provides that at least one committee member is a nonphysician health professional. 3. Prohibits the participation on the committee of any person who has a financial interest in the hospital. 4. Prohibits any person from participation in the review of any care in which that person has been professionally involved. 5. Provides for at least monthly meetings of the review committee. 6. Provides for the retention for at least seven years of records of the review committee's activities, including the number and types of cases received, the findings and recommendations, and the subsequent actions taken. (B) Proof of either insurance against medical injury liability claims or judgments up to $300,000 or the establishment of a reserve account in that amount, along with a plan for the investment of such reserves. (C) A written plan for the preliminary investigation of medical injury claims and for procurement of legal counsel when indicated. (D) A written plan to repay the State loan within forty (40) years detailing the resources available to the hospital district including taxing powers. Note: Authority cited: Sections 32351-32355 and 32358, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 23. s 101. Loan Application. (a) The hospital district shall make application for a State loan to the Director of Health Services, 714 P Street, Sacramento, CA 95814. (b) Within ninety (90) days after the receipt of the application the Department of Health Services will notify the applicant of its preliminary finding and recommendation. The notice will contain the information that the Department's final recommendation to the Legislature must be made within the next thirty (30) days and that any information that the applicant has that will affect the preliminary recommendation should be forwarded immediately. Note: Authority cited: Sections 32351-32355 and 32358, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 23. s 102. Coverage. (a) The Department shall grant all loans which qualify, to the extent that funds are available, provided that: (1) Such amount represents an excess of $300,000 in a medical injury tort judgment or settlement, the $300,000 being covered by insurance or reserve account, as specified in Section 100(a)(4)(B). (2) The total amount of such loans does not exceed $1,000,000 in the aggregate. (b) Physicians in the local community who are employees of the hospital district shall be covered for medical injury tort liability by the district. Note: Authority cited: Sections 32351-32355, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 23. s 103. Repayment of Loans. (a) Repayment of loans shall be on an amortized schedule agreed upon by the Department and the hospital district. The repayment period shall not exceed forty (40) years. The interest rate shall not exceed the five-year average on the return on the investment of State funds pursuant to Chapter 3 (commencing with Section 16430), Part 2, Division 4, Title 2 of the Government Code. (b) In event of default of repayment of a loan, the Department may attach real property and assets of the hospital district to recover the amount of the loan and appropriate interest as specified in (a) above. Note: Authority cited: Sections 32351-32355, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355 and 32358, Health and Safety Code, Division 23. Revision (except Group 1) filed 3-30-51 Revision of Group 2 filed 1-19-54 and 6-13-75 Revision of Group 1 filed 7-15-57 Note: Authority cited: Sections 1231 and 1411, Health and Safety Code. Note: Authority cited: Sections 102, 208 and 1411, Health and Safety Code. Reference: Sections 1400-1433, Div. 2, Ch. 2, Health and Safety Code. Note: Authority cited: Sections 102, 208 and 1411, Health and Safety Code. Reference: Sections 1400-1433, Div. 2, Ch. 2, Health and Safety Code; Note: Authority cited: Sections 11501, 11502, and 11503 of Insurance Code. Note: Authority cited for Sections 860.0-875.0: Section 1509, Health and Safety Code. Note: Authority cited for Sections 880 and 881: Section 212, Health and Safety Code. s 901. Access to the Records in the Office of the State Registrar and in the Offices of Local Registrars. Records of birth, death, and marriage in the Office of the State Registrar and in offices of local registrars for which access is not specifically prohibited by statute shall be open for examination by the public during regularly scheduled office hours subject to the restrictions listed in Health and Safety Code Sections 10125.5 and 10129. The principal researcher who needs access to confidential information shall submit a signed agreement to the State Registrar with a copy to the local registrar when appropriate, assuring that any report shall not identify an individual and that working papers which may permit such identification shall be destroyed as set forth in the agreement. Any breach of the signed agreement shall result in denial of further access to the data. No person, except as authorized by law, shall copy or retain copies of confidential data unless procedures in this section are followed. Note: Authority cited: Section 6253, Government Code; and Sections 10001 and 10001.1(b), Health and Safety Code. Reference: Sections 10066 and 10125.5, Health and Safety Code. s 902. Conditions of Examination. (a) Authorization to examine the index or records in the Office of the State Registrar and in offices of the local registrars must be obtained from the registrar or deputy in charge. Written application shall be made by the applicant stating sufficient information to identify the record or records to be examined. The following information for the type of record specified below should, whenever possible, be provided by the applicant: (1) Birth (A) Name of child; (B) Maiden name of mother; (C) Date or year of birth. (2) Death (A) Name of decedent; (B) Date or year of death, or date last known alive; (C) Date or year of birth. (3) Marriage (A) Name of Groom or Maiden name of Bride; (B) Date or year of marriage. Where the above information is not available, the applicant shall provide whatever information is available, and the State Registrar or local registrar shall make all reasonable effort to locate the requested records. (b) The State Registrar or local registrar shall supervise the examination of the records. Note: Authority cited: Section 6253, Government Code; and Sections 10001 and 10001.1, Health and Safety Code. Reference: Section 10066, Health and Safety Code. s 903. Fee for Examination or Search. Note: Authority cited: Sections 10001 and 10001.1(b), Health and Safety Code. Reference: Section 10066, Health and Safety Code. s 908. Late Registration of Births and Deaths. The local registrar and the State Registrar of Vital Statistics shall accept for registration only those records of birth and death which are received by the local registrar within one year of the date of occurrence of the event, except as provided under Division 9, Chapters 9 and 10 of the Health and Safety Code. Note: Authority cited: Section 10001, Health and Safety Code. Reference: Section 10577, Health and Safety Code. s 910. Responsibilities of Local Registrar or County Recorder. (a) Upon notification by the State Registrar that a person whose birth is registered in the local office is deceased, the local registrar or county recorder of such office shall make at least one of the following: (1) A notation of the death in the birth index. (2) A notation of the date of death and the death certificate number upon the record of birth. (b) The local registrar or county recorder shall notify the State Registrar of any application for a certified copy of a deceased person's birth certificate in which it is indicated that the requested birth record is the applicant's own birth record. (c) A birth card form shall not be issued where the birth record indicates the registrant is deceased. Note: Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Reference: Sections 10038, and 10575.5, Health and Safety Code. s 911. Identification of Deceased Registrants by Local Registrars and County Recorders. Local registrars and county recorders may match deaths occurring in their jurisdictions to births registered in their office and, for any registrants thereby identified as deceased, make any of the notations specified in Section 910(a) (1) and (2). Note: Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Reference: Sections 10038 and 10575.5, Health and Safety Code. s 912. Certified Copies of Birth Certificates of Deceased Persons. (a) All certified copies of birth records for which the registrant is identified as deceased shall display the legend "DECEASED," which shall be in boldface style not less than one-half inch in height, near the space reserved for the registrant's name. (1) Unless produced by a photographic process or through the medium of an overlay employed in the copying process, the legend "DECEASED" shall be printed or stamped in indelible ink. (2) The local registrar or county recorder shall obtain prior approval by the State Registrar of the method to be employed in producing the legend "DECEASED." Note: Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Reference: Sections 10038 and 10575.5, Health and Safety Code. s 915. Live Birth. "Live birth" means the complete expulsion or extraction from its mother of a product of conception (irrespective of the duration of pregnancy) which, after such separation, breathes or shows any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached. Note: Authority cited: Section 10001, Health and Safety Code. Reference: Sections 10100 and 10102, Health and Safety Code. s 916. Fetal Death. "Fetal death" means a death prior to the complete expulsion or extraction from its mother of a product of conception (irrespective of the duration of pregnancy); the death is indicated by the fact that after such separation, the fetus does not breathe or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord or definite movement of voluntary muscles. Registration of fetal deaths is subject to the provisions of Division 9, Chapter 4 of the Health and Safety Code. Note: Authority cited: Section 10001, Health and Safety Code. Reference: Section 10175, Health and Safety Code. Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Sections 1725, 1726, 1727, 1728, 1728.1, 1729, 1731, 1734, 1735, 1736, 1737, 1737.5, 3123 and 3124, Health and Safety Code. s 950. General Provisions. (a) As used in this chapter "person" includes firm, association and corporation. (b) As used in this chapter "department" means State Department of Health. Note: Authority cited for Group 1 (ss 950 to 1021, inclusive): Sections 208, 1600, 1603, 1604, 1605, and 1606, Health and Safety Code. Issuing agency: State Department of Public Health. s 951. Issuance of License. (a) All persons desiring to produce process or distribute biologics shall make application to the department on a form provided by the department, and shall supply such other information as may be required by the department for the intelligent appraisal of the status of the laboratory, the product to be licensed, and the personnel with respect to the intent and purpose of the law. (b) Licenses shall not be issued to any person not at the time fully prepared, equipped and actually processing (though not distributing), but the department will provide anyone contemplating the establishment of a processing laboratory with full information concerning the requirements and conditions for the preparation of the products that it is proposed to manufacture or distribute. (c) A license shall not be issued unless and until the establishment is prepared to operate under the direct supervision of a competent person trained in bacteriological technic and in the preparation of biologics as defined in Section 1601, Health and Safety Code, whose qualifications have been approved by the department. (d) A license shall not be issued unless the condition of the establishment and methods of preparation are such as to reasonably insure that the biologics produced will not be contaminated, dangerous, or harmful. (e) A license shall not be issued for the preparation of any biologic as defined in Section 1601, Health and Safety Code, if advertised so as to mislead or deceive the purchaser, or if the package or container in which the same is intended to be sold, bartered, exchanged, or shipped, bears or contains any statement, design, or device which is false or misleading in any particular. (f) A license shall not be issued for a biologic product that has been specifically forbidden or disapproved by the United States Department of Health, Education and Welfare excepting products that may be specifically approved by the department, for experimental purposes but not for general sale and distribution. (g) A license shall not be issued for the processing or distributing of any product without satisfactory scientific evidence of therapeutic or prophylactic value. s 952. Application for Renewal of License. Each licensee applying for renewal of license shall be subject to such review of his activities during the previous licensing period, and to such inspections of his premises, equipment and biologics produced by him as may be determined by the department for consideration in passing upon the application for renewal. Similarly, such licensee shall submit such data, records, and samples of products as may be designated by the department. s 953. License Fees. The fees for license application and for annual license renewal are six hundred dollars ($600). Note: Authority cited: Sections 102, 208, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety Code. s 956. Autogenous Vaccines. Laboratories whose principal activity is general clinical work and whose only biologic product is autogenous bacterial vaccines do not require a license for the preparation of autogenous vaccines unless the making of autogenous vaccines constitutes 10 percent or more of the activity or source of income of the laboratory. s 962. Inspection by Department. (a) Each licensee or applicant shall permit any duly authorized employee of the department to enter his establishment at any reasonable hour, and shall permit said representative of the department to inspect without previous notification the entire premises of such establishment, including all buildings, compartments, and other places, and all equipment, such as chemicals, instruments, apparatus, and the like, as well as the methods used in the manufacture of, and all records maintained relative to biologics as defined in Section 1601, Health and Safety Code. (b) Each licensee or applicant shall provide to the department such stock cultures or other materials from which biologics are produced and such completed products as may be required by the department for testing of identity, purity, potency or other analysis. s 963. Records. The licensee shall keep records of the source of the preparation, of tests for purity and potency, and of the methods of preparation of each batch of biologics as defined in Section 1601, Health and Safety Code, and the sale, shipment or other disposition of the same. The licensee shall supply to the department monthly, on forms provided by the department, such information from said records as the department may require, the licensee retaining a full and complete copy thereof in his files. s 967. Storage. Each licensee shall maintain a refrigerator of sufficient capacity to store all of those products in his possession which require refrigeration and the entire stock of such products shall be kept within the refrigerator at all times. The temperature of the refrigerator shall not be permitted to rise above 10 degrees C. or fall below 1 degree C., as indicated by a required standard mercury thermometer, except that storage below 1 degree C. is allowed if not specifically damaging to the product. Licensee shall not sell or distribute for resale or redistribution biologics which require refrigeration unless the purchaser or distributor for resale or redistribution is equipped to store said biologics in the manner above provided. s 972. Containers and Labeling. (a) No biological product either for human or animal use shall be distributed except in the original final container bearing the original label of the manufacturer; provided, however, that a licensed laboratory may purchase products from other producers likewise licensed by the State, and repack and relabel such products in smaller containers; provided, there are no changes, substitutions or additions in the product or the label, and further provided, that all such repacked biological products shall bear on the label the name of the manufacturer as well as the name of the distributor together with a statement that the product has been repacked. All such repacked products are subject to the requirements of Sections 1600 to 1621, inclusive, Health and Safety Code, and are not exempted from inspection and license by the department. (b) The labels of all biologic products on the containers for general distribution shall show the name of the product, the lot number that will identify the lot or batch in the record of the manufacturer, the expiration date, and the name of the manufacturer. The expiration date shall be based on a period of duration approved by the department. (c) The labels on all bottles and individual packages of bacterial vaccines (bacterins) shall give the correct name of the organism concerned and mixed bacterins shall give the names of each organism according to the classification of Bergey in the mixture and the proportion that each organism represents in the mixture. The concentration may be expressed in number per mil or in terms of a turbidity standard acceptable to the department. (d) The labels on products requiring refrigeration or maintenance of uniform temperatures to avoid deterioration, shall specify the temperature range within which the product shall be maintained. (e) To prevent accidental use, all stocks of labels and advertising not accepted by the department shall be destroyed. s 977. Advertising. (a) No statements regarding preventive or therapeutic value shall be made either on labels or circulars or in any form of advertising that are not in accord with the opinion held by the recognized authorities of the medical profession and no descriptive matter or discussion of mode of action of the product or theory of its applicability may be used that is not acceptable to the same authorities. (b) No mention of the department shall be made in advertising either directly or indirectly. (c) All advertising matter, statements, and representations pertaining to biologics licensed under Sections 1600 to 1620, Health and Safety Code, shall be submitted to the department at least 30 days prior to their use by the licensee. s 982. Potency. Licensees producing, processing or distributing biologics for which a potency test is recognized or prescribed by the United States Department of Health, Education, and Welfare, shall upon the request of the department, provide a representative sample of each lot of such product for purposes of checking. The particular lot so sampled shall not be distributed until approval is given by the department. s 987. Vaccine Culture. No culture shall be used in the preparation of live culture vaccine unless it is nonvirulent or has sufficiently low virulence as not to be reasonably likely to produce the disease in the inoculated person, or be dangerous from the standpoint of contagion. Such cultures must be tested and approved by the department before use. The following conditions must be met and observed in the procurement, processing, storage, and distribution of whole blood (human) or blood derivatives for transfusion purposes: The following conditions must be met and observed in the procurement, processing, storage, and distribution of whole blood (human) or blood derivatives for transfusion purpose. s 997. Definitions. As used in this article: (a) Blood Bank is a medical facility designed, equipped, and staffed to procure, to process, to store, or to distribute human whole blood or blood derivatives for transfusion purposes. (b) For implementation of these regulations, a blood bank depository also is designated as a transfusion service. A transfusion service shall be a component of a clinical laboratory holding a license in accordance with the provisions of Chapter 3 (commencing with Section 1200) Division 2 of the Business and Professions Code, or such other place where services essentially equivalent are maintained as determined by the department. A transfusion service shall be responsible for all functions related to storage and preparation of blood for transfusion, except those activities requiring a biologics license, in accordance with the Health and Safety Code, Division 2, Chapter 4 (commencing with Section 1600). Institutions which fulfill criteria for both a clinical laboratory license and a biologics license may maintain the combined services of a blood bank and a transfusion service. (c) Blood collection center is a stationary auxiliary to a blood bank which is designed, equipped and staffed to procure human whole blood and to transport this blood to the blood bank for processing, storing and distribution. (d) Mobile unit is a transportable auxiliary to a blood bank designed, equipped, and staffed to procure human whole blood and to transport this blood to the blood bank for processing, storing and distribution. (e) Whole blood is the fluid component of the human cardiovascular system composed of liquid and cellular elements. (f) Plasma is the extracellular portion of anticoagulated whole blood. (g) Blood derivatives or fractionation products are the individual elements of whole blood which have been processed or manufactured into their individual component parts, in accordance with procedures contained in Articles 10 and 11. (h) Donor means the individual from whom blood is procured. (i) All references to temperature are expressed in degrees centigrade. Note: Authority cited: Sections 1602.5, 1603, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1620, Health and Safety Code. s 998. Personnel of Blood Banks and Their Auxiliaries. (a) Physicians and surgeons, clinical laboratory bioanalysts, clinical laboratory technologists, clinical laboratory technologist trainees and nurses who comprise the staff of the blood bank shall be duly licensed by or registered in the State of California. The staff may include such other persons, when approved by the director, as may be necessary for the proper operation of the blood bank, including volunteer workers. (b) Director of Blood Bank. The blood bank and its auxiliaries shall be under the direction of a physician and surgeon duly licensed by the State of California, and who shall have a minimum of six months experience in blood bank methods, transfusion principles, and transfusion practices, satisfactory to the department. Attending Physician refers to the duly licensed physician and surgeon supervising blood collection activities. (c) Laboratory Personnel. The laboratory personnel shall be licensed pursuant to the Clinical Laboratory Laws (California Business and Professions Code, Division 2, Chapter 3), except that unlicensed persons may be used to assist licensed personnel under their supervision, so long as such unlicensed persons do not perform laboratory tests or render judgment on such tests. Note: Authority cited: Sections 208 and 1603, Health and Safety Code. Reference: Section 1603(c), Health and Safety Code. s 999. Blood Bank Equipment, Facilities and Manual. Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code. s 1000. Blood Bank Records; Identification of Human Blood with Its Donor. (a) A system which carries through from donor to recipient must be used to identify the blood. This shall be accomplished by having blood container and pilot tube labels identified with the donor before venesection. The labels and personal history shall carry the same identification number. These labels shall accompany the donor to the collection room and shall be applied to the blood container and pilot tubes while it is still possible to check accurately the identity of the blood with the donor and his history. Other documents related to the blood such as invoices, if used, shall also contain the same identification number. (b) Every California licensed blood bank shall obtain reports of reactions in individuals receiving its blood, or blood derivatives, where it appears that these materials from the blood bank may be implicated in such reactions. Reporting shall include also any illness whose cause may be related to transfusion of blood or blood derivatives provided by the blood bank. Forms for these purposes may be devised by the blood bank as a reminder to the transfusion services and as encouragement to them to comply with this requirement. (c) In addition to the applicable portions of the regulations set forth in Section 963 and the first two paragraphs of this section, the blood bank shall keep complete records of each donor, which shall include all information specified in Section 1002. Records are required also which contain information related to the disposition of all blood collected or distributed. (d) These records shall be kept for an interval of not less than five years after the expiration date of the blood unit involved. All such records shall be correlated in such a way that checking the complete history of each blood unit may be quickly and conveniently performed. (e) Records of refrigerator temperatures shall fulfill the requirements contained in Section 1002(g)(2) of these regulations. (f) All blood bank records shall be dated. Note: Authority cited: Sections 208 and 1603, Health and Safety Code. Reference: Section 1603, Health and Safety Code. s 1001. Labels. Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code. s 1002. Requirements -Donors, Medical History, Blood Collection, Storage and Testing. (a) Responsibilities. Final responsibility for the acceptance of donors rests with the attending physician. Any time blood is collected under license, adequate medical care for the donor shall be provided. Blood shall be drawn from the donor under the supervision of a physician or registered nurse trained in the procedure. Blood may be collected when a physician is not present on the premises under the following conditions: (1) The medical director and his medical advisory committee, if he has one, must approve. (2) The employee placed in charge, in the absence of a qualified physician must be a registered nurse. (3) The nursing staff and medical director must have a mutually clear understanding of the criteria for donor selection. Consultation with the medical director by telephone from mobile unit operations about certain donors may be necessary. (4) A qualified physician or emergency medical facility shall be available nearby. Having a physician or emergency medical facility available is for the purpose of attending to donors who have a severe reaction or accident related to the blood donation. "Available" means no longer than 15 minutes away. (5) Written emergency standing orders for donor care must be prepared by the medical director and be made available to the nursing staff. Appropriate training and refresher courses in emergency resuscitative methods must be planned. The nursing staff must be given special training on the symptomatology and emergency treatment of such conditions as cardiac and vascular disease, syncope, fractures, etc. The attending physician shall sign all donor records, except that he may delegate the responsibility for signature to an employee of the blood bank whose license permits him to perform functions related to medical practice when under medical supervision. Irrespective of location, the blood bank under whose license the blood is to be processed shall be responsible for all personnel engaged in examining donors and collecting blood, as well as the space and equipment used. (b) Collection of Blood. (Refer to Section 1000(a) for requirements relative to donor identification.) (1) Protection of the Donor Against Infection and Injury. The preparation of the skin at the sites of venipuncture and of injections incidental to venipuncture shall be adequate to protect the donor against infection. Apparatus or instruments such as syringes, needles, and lancets or other blood-letting devices capable of transmitting infection from one donor to another shall be sterile single-use instruments insofar as possible. All such instruments intended for reuse shall be heat sterilized prior to each use and protected against contamination. Heat sterilization shall be by autoclaving for 30 minutes at 121.5 C (15 lb. p.s.i. pressure), by dry heat for two hours at 170 C, or by boiling in water for 30 minutes. Times, temperatures and pressures in excess of those stated are permissible. Such heat sterilization shall include the use of a heat indicator satisfactory to the department, which will serve as evidence of proper sterilization. The heat indicator used shall be retained for one year as a record relating to the sterilization in which it was used. The record of temperature attained shall be kept on file in the blood bank for five years. This record may be kept either as hand-written chart showing temperatures at different times, or as information from an automatic recorder. Instruments used in puncturing the skin, if not prepared for reuse, shall be disposed of in such a way that they cannot be reused. Thermometers shall be sufficiently cleansed before use to minimize the transmission of disease. The staff concerned with blood collection shall be instructed in the first aid procedures to be used in the event of a reaction, and suitable drugs and supplies shall be immediately available for use. Donors shall be kept under continuous observation throughout the entire procedure of blood collection and for at least 15 minutes thereafter. (c) Laboratory Tests. (1) Serologic Tests for Syphilis. A serologic test for syphilis approved by the department shall be made on a sample of blood taken from the donor at the time of blood collection. Blood shall not be used for transfusion unless the result of this test is nonreactive (negative), except in emergency situation with the consent of the blood bank director and the patient's attending physician. All California licensed blood banks must accept and test evaluation sera provided by the department or a proficiency testing service approved by the department, and report test results to the department. Any blood bank laboratory showing unsatisfactory performance shall make changes as recommended by the department. (d) Issue of Blood. Issuance of blood shall be in compliance with the provisions of the Health and Safety Code, Division 2, Chapter 4, Sections 1600.3 and 1604. The laboratory tests and other procedures with respect to the preparation of blood for transfusion after it has been delivered to a transfusion service by the blood bank shall be the sole responsibility of the transfusion service. (See Section 1605 of the Health and Safety Code.) As a condition to supplying blood, the blood bank director may inquire into the pretransfusion procedures used by the transfusion service and he may suggest as a minimum those described in the latest edition of "Standards for Blood Banks and Transfusion Services," published by the American Association of Blood Banks. Blood banks shall not supply blood to transfusion services in which the department finds pretransfusion procedures which differ from these standards, or from such other standards which are essentially equivalent to these, as determined by the department. Note: Authority cited: Sections 1602.5 and 1603, Health and Safety Code. Reference: Sections 1602.5 and 1603, Health and Safety Code. s 1002.1. Use of AIDS Antibody (HTLV-III) Test by Blood Banks. Note: Authority cited: Sections 208 and 1603, Health and Safety Code. Reference: Section 1603, Health and Safety Code. s 1003. Exceptions for Emergency Purposes. In the event that an emergency occurs as defined in Chapter 7 (California Emergency Services Act), Division 1, Title 2 of the Government Code deviation from the provisions of Section 1001 and subsections (a) through (h) of Section 1002 of this Article will be permissible. The extent of deviation shall be determined by the blood bank director with concurrence by the department and shall be commensurate with the degree of emergency. s 1004. Reporting Requirements. (a) Notification of Positive Laboratory Finding for Syphilis. To assist the local health officer in the discharge of his duties under Section 3110 and 3194 of the Health and Safety Code, any person who is in charge of a blood bank in which a laboratory examination of any specimen derived from a donor yields serological or other evidence of syphilis shall promptly notify the health officer of the local health jurisdiction of the address of the donor. This notification shall contain the type of specimen, the date it was obtained, the nature and result of the test performed, and the name, address, and the date of birth of the donor who provided the specimen. The notification may be made by mailing or otherwise delivering a legible copy of the laboratory report containing all of the required information or by a telephone communication which is documented in the blood bank's records. (b) The notifications required in this section are confidential and not open for public inspection. Note: Authority cited: Sections 1603, 1603.1(g), 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety Code. The following must be met and observed for the procurement, processing, storage and transportation of human blood for plasma: s 1010. Procurement of Blood for Plasma Processing. Note: Authority cited: Sections 1603, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1620, Health and Safety Code. s 1011. Personnel and Equipment. Blood shall be processed into plasma only in blood banks adequately staffed and equipped for that purpose. The individual directly in charge of plasma processing shall be a physician and surgeon duly licensed by the State of California or an individual sufficiently trained in laboratory procedures relating to blood banking and plasma processing and whose qualifications have been approved by the department. The staff may include other trained persons necessary for the proper operation of plasma processing. s 1012. Single Donor Plasma and Single Donor Fresh Frozen Plasma (Antihemophilic). Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code. s 1013. Storage. Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code. s 1014. Expiration Date. Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code. s 1015. Other Tests. s 1016. Filling the Final Container. s 1017. Labeling. s 1018. Diluent for Dried Plasma. s 1021. Requirements for Release. s 1024. Red Blood Cells (Human). Note: Authority cited: Sections 1603, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1620, Health and Safety Code. s 1024.1. Frozen Red Blood Cells. Note: Authority cited: Sections 1602.5, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety Code. s 1025. Plasmapheresis. (a) Requirements: (1) No more than 500 milliliters of whole blood shall be removed from a donor at one time, unless the donor's weight is 175 pounds or greater in which case no more than 600 milliliters of whole blood shall be removed from the donor at one time. (2) A duly licensed physician and surgeon shall be available as described in Section 1002(a) when plasmapheresis is performed. (3) A system shall be employed which gives maximum assurance against any possibility of return of the separated red cells to an individual other than their donor. (b) Examination and Laboratory Tests. Examinations and laboratory tests to assist in determining the donor's health shall include the following: (1) Within no more than one week prior to the initial plasmapheresis, the donor shall be examined and certified to be in good health by a duly licensed physician and surgeon, as indicated in the applicable sections of the regulations. All donors shall have a physical examination by a duly licensed physician and surgeon at least once a year. (2) A whole blood hemoglobin or hemoglobin or hematocrit concentration shall be performed prior to each plasmapheresis procedure. (3) Determination of total protein shall be done at the time of each plasmapheresis procedure. the total protein shall not be less than 6.0 grams per 100 ml of plasma. (4) The ratios of the various protein components of the donor's serum shall be determined from a sample taken at the time of his initial plasmapheresis and at intervals of not more than four months thereafter so long as he remains on a plasmapheresis program. (5) To qualify for further plasmapheresis, all of the values determined under this section must be within the acceptable normal range. (c) Samples for Laboratory Tests. Samples for laboratory tests shall not exceed 30 ml of whole blood in a seven-day period. Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code. s 1026. Other Blood Fractions; Procedures; Standards; Consultative Service. Since procedures and standards for the preparation of other blood fractions, such as immune serum globulin, albumin, etc., for transfusion purposes are not as yet well suited for blood bank production, any biologies producer operating under the license of the department shall submit a complete protocol of procedures to be followed and shall be subject to the current specifications of the department regarding such products. This shall include specific licensure for the production of such materials, inspection, and the maintenance of appropriate standards. Such standards as are necessary will, in general, follow the usual blood banking procures with deviations general, follow the usual blood banking procedures with deviations only for specific reason. Such deviations and specific procedures shall be outlined in writing to the department by the biologics producer. Potential producers of such biologics should avail themselves of the consultative services of this department in order to provide for a proper production procedure consistent with regulations of the department, thus avoiding the installation of methods which must later be amended or changed. s 1027. Definitions and Procedures to Be Followed. (a) For the purpose of this article "person" includes laboratory, firm, association, corporation, co-partnership, and educational institutions, and "department" means State Department of Health. (b) Etiologic Agents. (1) For the purpose of this article microorganisms which may produce disease in man shall be referred to as etiologic agents. (2) The provisions of this article do not apply to specimens transmitted to a laboratory operated by the State Department of Health or equivalent containers are used, or those of other public health department laboratories operating under certificates issued by the department. (3) The provisions of this article do not apply to biological products licensed by the department or by the United States Department of Health, Education and Welfare. (c) The following safety measures shall be used by persons initiating the transportation of etiologic agents. (1) Containers shall be used which are constructed in a manner equivalent to those referred to in (b)(2) of this section. (2) In the case of frozen materials the etiologic agent shall be packed in sufficient dry ice and insulation material to insure that the material will remain frozen for at least 24 hours longer than the expected time in transportation. (3) The proposed recipient shall be notified when transportation of the etiologic agent begins. This shall include type of transportation and probable time of arrival at a designated place. (4) The approved type of container, referred to in (b)(2) above, shall be labeled in such a way that the etiologic agent which it contains is clearly indicated in bold type. The label shall state clearly that material of an infectious nature is present within the container. (5) The label shall state that if breakage or leakage occurs whoever first has knowledge of the accident will immediately notify the department and the local health officer having jurisdiction at the site of the accident. This report should also contain the names and addresses of those who may have been exposed to the etiologic agent as a result of the accident. If loss occurs the person first aware of this occurrence shall notify the department promptly and shall supply such additional details as may be available. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 1603.5, Health and Safety Code. s 1028. Waiver of Regulations. Notwithstanding the other provisions of Group 1, Subchapter 1, Chapter 2 of Part I (commencing with Section 950) of Title 17 relating to the production and distribution of biologics, the Director may at his discretion waive such regulations for research projects approved by the Director. The waiver shall be for a specific period of time and subject to all conditions which the Director finds necessary to protect the public health. Note: Authority cited: Section 102 and 208, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety code. s 1029. General Definitions. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241, 1244, 1265, 1281, 1282, 1285, 1288.5 and 1300, Business and Professions Code. s 1029.5. Accreditation Body. "Accreditation body" means an approved accreditation organization for laboratories, as defined in 42 Code of Federal Regulations, Section 493.2. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and 1288.5, Business and Professions Code. s 1029.6. Accredited Institution. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and 1288.5, Business and Professions Code. s 1029.7. Accredited College or University. "Accredited college or university" means an educational facility which has met the standards of the United States of America Accrediting Commission for Senior Colleges and Universities or the Accrediting Commission for Community and Junior Colleges; or, if a non-United States college or university, one that is evaluated and found equivalent by the American Association of Collegiate Registrars and Admissions Officers. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1260, 1261, 1261.5, 1263 and 1264, Business and Professions Code. s 1029.9. Accredited Institution. "Accredited institution" has the same meaning as given in Title 42 of the Code of Federal Regulations, Section 493.2. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code. s 1029.10. Accusation. "Accusation" means a written statement filed in order to initiate a hearing to determine whether a right, authority, license, or privilege should be revoked, suspended, limited or conditioned, and which: (a) Sets forth in ordinary and concise language the acts or omissions with which a person, entity, or laboratory and its owners or directors are charged with committing to the end that the person, entity or laboratory and its owners or directors will be able to prepare a defense; and (b) Specifies the statutes and regulations alleged to have been violated. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 1326, Business and Professions Code; Section 11503, Government Code; and Section 14123, Welfare and Institutions Code. s 1029.11. Antigen. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code. s 1029.13. Approved Public Health Laboratory. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5, Business and Professions Code. s 1029.15. Alternative Sanction. "Alternative sanction" means one or more of the following sanctions: (a) Directed plan of correction; (b) Civil money penalty; or (c) Onsite monitoring. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Stats. 1995, c.510, Section 1; and Section 1310, Business and Professions Code. s 1029.17. CLIA Certificate. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224, 1265, 1281 and 1288.5, Business and Professions Code. s 1029.19. CLIA Exempt Status. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 113) Section 1(a)(6). s 1029.20. Antibody. "Antibody" means an immunoglobulin molecule that, due to its specific amino acid sequence, reacts to the antigen that induced its synthesis in the cells of the lymphoid series. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code. s 1029.23. Direct Patient Care. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1206.5, Business and Professions Code. s 1029.25. Antigen. "Antigen" means any viral component including, but not limited to, proteins and nucleic acids. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code. s 1029.27. HHS. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business and Professions Code. s 1029.30. Approved Public Health Laboratory. "Approved public health laboratory" means a laboratory that has been issued a certificate of approval by the department after its determination that the public health laboratory, as defined in Business and Professions Code section 1206(a)(11), is in conformity with chapter 7 (commencing with section 1000) of part 2 of division 1 of the Health and Safety Code and the regulations adopted thereunder. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5, Business and Professions Code. s 1029.31. Arterial Puncture. "Arterial puncture" means the penetration of an artery with a needle to withdraw blood for clinical laboratory test or examination purposes. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1242, 1242.5, 1242.6, 1243, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.32. Certified Phlebotomy Technician I. "Certified phlebotomy technician I" means a person who has completed the education, training, experience and examination requirements pursuant to Section 1034 and is certified by the department to perform skin punctures and venipunctures. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.33. Certified Phlebotomy Technician II. "Certified phlebotomy technician II" means a person who has completed education, training, experience and examination requirements pursuant to Section 1034 and is certified by the department to perform skin punctures, venipunctures and arterial punctures. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.34. Certifying Organization. "Certifying organization", also called a national accreditation or accrediting board or agency, means an organization, agency or body that creates competency examinations that measure the skill, knowledge and aptitude required of an individual in a profession, occupation or discipline. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1246, 1262, 1264 and 1270, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.35. Chapter 3. "Chapter 3" means chapter 3 (commencing with section 1200) of division 2 of the Business and Professions Code. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1224, Business and Professions Code. s 1029.37. Instrument. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and 1269, Business and Professions Code. s 1029.39. Licensed General Acute Care Hospital. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business and Professions Code. s 1029.40. Civil Money Penalties. "Civil money penalties" means the civil money penalties imposed by the department under the procedures identified in section 1067.5. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Section 1310, Business and Professions Code. s 1029.43. Patient. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241 and 1269, Business and Professions Code. s 1029.44. Preceptor. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220 and 1265, Business and Professions Code. s 1029.45. CLIA Certificate. "CLIA certificate" means an unsuspended and unrevoked certificate of compliance, certificate for provider-performed microscopy procedures, certificate of accreditation, certificate of registration or a certificate of waiver, as defined in 42 Code of Federal Regulations section 493.2. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224, 1265, 1281 and 1288.5, Business and Professions Code. s 1029.47. Respiratory Care Practitioner. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business and Professions Code. s 1029.49. Specimen. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1209, 1225, 1241, 1244, 1269, 1288, 1288.5 and 1320, Business and Professions Code. s 1029.50. CLIA Exempt Status. "CLIA exempt status" means that the United States Department of Health and Human Services (HHS) has exempted clinical laboratories licensed, registered or otherwise approved by the department from the requirements of CLIA pursuant to subsection (p) of section 263a of title 42 of the United States Code and section 493.513 of title 42 of the Code of Federal Regulations. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 113) Section 1(a)(6). s 1029.51. Clinical Consultant. "Clinical consultant" means a person who meets the requirements of Section 493.1455 of Title 42, Code of Federal Regulations, as published October 1, 1994, and who provides clinical consultation of a laboratory in accordance with Section 1036 of this title and Section 493.1457 of Title 42, Code of Federal Regulations, as published October 1, 1994. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code. s 1029.52. Clinical Cytogenetics. "Clinical cytogenetics" means the techniques used to isolate, replicate and identify whole or parts of human chromosomes including culturing, manipulation, banding, staining and hybridizing, and analysis with respect to genotype and phenotype. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1210, 1261.5 and 1264, Business and Professions Code. s 1029.53. Clinical Genetic Molecular Biology. "Clinical genetic molecular biology" means the determination of all the aspects of molecular organizations of the nucleic acids of the human genome with respect to genotype and phenotype. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1210, 1261.5 and 1264, Business and Professions Code. s 1029.55. Condition Level Deficiency. "Condition level deficiency" means noncompliance with one or more condition level requirements. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code. s 1029.57. Test Purposes. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6 and 1246, Business and Professions Code. s 1029.59. Unprofessional Conduct. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1320, Business and Professions Code. s 1029.60. Condition Level Requirement. "Condition level requirement" means any of the requirements specified in section 1066. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code. s 1029.65. Deficiency. "Deficiency" or "Violation" means noncompliance with one or more of the requirements in chapter 3, division 2 of the Business and Professions Code (commencing with section 1200) or any rule or regulation adopted thereunder. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Sections 1310, 1320, 1323 and 1326, Business and Professions Code. s 1029.70. Direct Patient Care. "Direct patient care" means medical, psychiatric, nursing or other health care which is legally provided by a care giver or healthcare provider directly to a patient, and which includes observation of the patient's physical or mental condition to enable the care giver or healthcare provider to report changes in the patient's condition. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1206.5, Business and Professions Code. s 1029.75. Directed Plans of Correction. "Directed plans of correction" means the directed plans of correction imposed by the department under the procedures identified in section 1067. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code. s 1029.80. Electrolytes. "Electrolytes" means ionized calcium, sodium, potassium and/or chloride. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1206, Business and Professions Code. s 1029.81. Evidence of Satisfactory Performance. "Evidence of satisfactory performance" means a copy of a document issued to an examinee by the department for satisfactory performance on a department-administered licensing written examination, or by a certifying board or organization indicating satisfactory performance by the examinee on a written certifying examination. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261, 1261.5, 1262 and 1264, Business and Professions Code. s 1029.82. Field Related to Genetics. "Field related to genetics" means a major in molecular biology, reproductive biology, biochemistry, clinical genetics, medical genetics, clinical cytogenetics, biochemical genetics, human genetics, clinical laboratory science, or clinical molecular genetics. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206 and 1210, Business and Professions Code. s 1029.83. General Supervisor. "General supervisor" means a person who meets the requirements of Section 493.1461 of Title 42, Code of Federal Regulations, as published October 1, 1994, and who provides general supervision of a laboratory in accordance with Section 1036.1 of this title and Section 493.1463 of Title 42, Code of Federal Regulations, as published October 1, 1994. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code. s 1029.85. HHS. "HHS" means the federal Department of Health and Human Services, or its designee. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business and Professions Code. s 1029.86. High Complexity Tests or Examinations. "High complexity tests or examinations" mean those clinical laboratory tests or examinations classified as high complexity under CLIA. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1203, 1204, 1206, 1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code. s 1029.90. Human Immunodeficiency Virus. "Human Immunodeficiency Virus" or "HIV" means the etiologic virus of Acquired Immune Deficiency Syndrome, or AIDS. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code. s 1029.95. Immediate Jeopardy. "Immediate jeopardy" means a situation in which immediate corrective action is necessary because the laboratory's noncompliance with one or more conditions has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health or safety of the general public. This term is synonymous with imminent and serious risk to human health and significant hazard to the public health. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c. 510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; and Sections 1310, 1320, 1323 and 1326, Business and Professions Code; and Section 14123, Welfare and Institutions Code. s 1029.100. Instrument. "Instrument" means a device, apparatus, implement, machine or contrivance that is used for the performance of a clinical laboratory test or examination, Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and 1269, Business and Professions Code. s 1029.105. Intermediate Sanction. "Intermediate sanction" means either or both: (a) Temporary suspension of a license, registration or approval; or (b) Temporary suspension of a provider of service under the Medi-Cal program. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; and Section 1323, Business and Professions Code; Section 1002, Health and Safety Code; Section 14123, Welfare and Institutions Code; 42 United States Code, Section 1395w-2 (Section 1846 of the federal Social Security Act); and 42 United States Code, Section 1396a(a)(9) (Section 1902(a)(9)(C) of the federal Social Security Act). s 1029.108. License. For the purposes of this chapter, "license" means license, certificate, registration or other means to engage in a business or profession regulated by Chapter 3. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 23.7, 1203, 1204, 1205, 1206.5, 1207, 1208, 1209, 1210, 1220, 1227, 1242, 1246, 1246.5, 1260, 1260.1, 1261, 1261.5, 1262, 1263, 1264, 1265, 1267, 1269.5, 1270, 1275, 1280, 1281, 1285, 1288.5, 1300, 1301, 1301.1, 1310, 1320, 1322, 1323, 1324 and 1325, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.110. Licensed General Acute Care Hospital. "Licensed general acute care hospital" means a facility as defined in section 1250(a) of the Health and Safety Code that has been licensed pursuant to chapter 2 (commencing with section 1250) of division 2 of the Health and Safety Code. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business and Professions Code. s 1029.111. Licensed Healthcare Professional. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5 and 1208, Business and Professions Code. s 1029.115. Licensed Surgical Clinic. "Licensed surgical clinic" means a facility as defined in section 1204(b)(1) of the Health and Safety Code that has been licensed pursuant to chapter 1 (commencing with section 1200) of division 2 of the Health and Safety Code. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business and Professions Code. s 1029.116. Limited Phlebotomy Technician. "Limited phlebotomy technician" means a person who has completed the education, training and experience requirements pursuant to Section 1034 and is certified by the department to perform skin punctures. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.117. Medical Laboratory Technician. "Medical laboratory technician" means a person who has completed education, training or experience, and examination requirements pursuant to Section 1032.5(a), and who is authorized to perform clinical laboratory tests and examinations specified in Section 1032.5(b). Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1210, 1242, 1260.3, 1264 and 1300, Business and Professions Code. s 1029.118. Moderate Complexity Laboratory Technical Consultant. "Moderate complexity laboratory technical consultant" means a person who meets the qualifications of Section 493.1411 of Title 42, Code of Federal Regulations, as published October 1, 1994, and who provides technical oversight in accordance with Section 1036.2 of this title and Section 493.1413 of Title 42, Code of Federal Regulations, as published October 1, 1994. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code. s 1029.119. Moderate Complexity Tests or Examinations. "Moderate complexity tests or examinations" mean those clinical laboratory tests or examinations classified as moderate complexity under CLIA. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1203, 1204, 1206, 1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code. s 1029.120. Notice of Defense. "Notice of Defense" means a writing signed by or on behalf of the person, entity or laboratory, stating the mailing address of the person, entity, or laboratory, and may: (a) Request a hearing. (b) Object to the accusation upon the ground that it does not state acts or omissions upon which the agency may proceed. (c) Object to the form of the accusation on the ground that it is so indefinite or uncertain that the person, entity, or laboratory cannot identify the transaction or prepare a defense. (d) Admit the accusation in whole or in part. (e) Present new matter by way of defense. (f) Object to the accusation upon the ground that, under the circumstances, compliance with the requirements of a regulation would result in material violation of another regulation enacted by another department affecting substantive rights. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 1326, Business and Professions Code; Sections 11503 and 11504, Government Code; and Section 14123, Welfare and Institutions Code. s 1029.124. On-the-Job Experience in Phlebotomy. "On-the-job experience in phlebotomy" means employment as a phlebotomist in a clinical laboratory performing the techniques pursuant to Section 1035.1(f). Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6, 1243, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.125. Onsite Monitoring. "Onsite monitoring" means the onsite monitoring imposed by the department under the procedures identified in section 1067.10. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference: Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code. s 1029.126. Oral and Maxillofacial Pathology Laboratory Director. "Oral and maxillofacial pathology laboratory director" means a dentist who possesses a valid, unexpired license to direct an oral pathology laboratory in all areas of anatomic and clinical pathology related to the oral and maxillofacial region. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1207, 1208 and 1209, Business and Professions Code. s 1029.127. Oral Pathology. "Oral pathology" means the subspecialty of pathology that deals with the nature, identification and management of diseases affecting the oral and maxillofacial regions, which investigates the causes, processes and effects of these diseases, and includes research and diagnosis of diseases using clinical, radiographic, microscopic, biochemical or other examinations. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206 and 1207, Business and Professions Code. s 1029.130. Patient. "Patient" means a person who is an inpatient or outpatient of a licensed health facility, licensed clinic or a clinic that is exempt from licensure, licensed home health agency, or who is a patient of a licensed physician and surgeon or osteopath, licensed dentist, or licensed podiatrist. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241 and 1269, Business and Professions Code. s 1029.132. Phlebotomist. "Phlebotomist" means a person who collects blood for clinical laboratory test or examination purposes. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.133. Phlebotomy. "Phlebotomy" means the process of collecting blood by venipuncture, arterial puncture or skin puncture for the purpose of obtaining blood for clinical laboratory test or examination purposes. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.134. Practical Experience. "Practical experience" means hands-on, direct work experience in clinical laboratory science and phlebotomy techniques on real patients in a clinical laboratory certified by CLIA, using equipment, instruments, kits and materials routinely found in clinical laboratories performing moderate or high complexity tests or examinations, and does not include work done in academic, research, forensic, pharmaceutical or veterinary laboratories. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1222.5, 1242, 1242.5, 1243, 1246, 1260, 1260.3, 1261, 1261.5, 1264, 1269 and 1286, Business and Professions Code. s 1029.135. Preceptor. "Preceptor" means: (a) The laboratory director or the technical consultant of the laboratory, as that term is defined under CLIA; or, (b) A person who: (1) Meets the qualifications of a technical consultant under CLIA and of chapter 3 to perform clinical laboratory tests or examinations classified as of moderate complexity; and, (2) Is assigned by the laboratory director or the technical consultant of the laboratory to act as a preceptor; or, (c) Any person listed in subdivision (b) of section 1206.5 of the Business and Professions Code, except for those persons listed in subsections (10), (11), or (12) of subdivision (b), and who: (1) Has two years of experience performing moderate complexity tests upon the instrument(s) for which she or he will act as a preceptor; and (2) Meets any CLIA requirements necessary to perform his or her duties and responsibilities in a preceptor program; and (3) Is assigned by the laboratory director or the technical consultant of the laboratory to act as a preceptor. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220 and 1265, Business and Professions Code. s 1029.140. Principal Sanction. "Principal sanction" means: (a) Suspension or revocation of a registration or license issued under chapter 3 of division 2 of the Business and Professions Code; or (b) Suspension or revocation of the approval to operate a public health laboratory granted under chapter 7 (commencing with section 1000) of the Health and Safety Code; or (c) Suspension of a provider of service from further participation in, including reimbursement from, the Medi-Cal and Medicaid programs. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c. 510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; Sections 1320 and 1322, Business and Professions Code; Section 1002, Health and Safety Code; and Section 14123, Welfare and Institutions Code. s 1029.145. Provider of Service. "Provider of service" has the same meaning as given in 22 CCR 51051. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c. 510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; and Section 14123, Welfare and Institutions Code. s 1029.150. Respiratory Care Practitioner. "Respiratory care practitioner" means an individual licensed pursuant to chapter 8.3 (commencing with section 3700) of division 2 of the Business and Professions Code. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business and Professions Code. s 1029.153. Satisfactory Performance. "Satisfactory performance" means achieving at least the minimum grade that an examinee must obtain to get a passing score on a written or oral examination. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261, 1261.5, 1262 and 1264, Business and Professions Code. s 1029.154. Skin Puncture. "Skin puncture" means penetration of the skin for the purpose of collecting capillary blood for clinical laboratory test or examination purposes. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.155. Specimen. "Specimen" has the same meaning as given for "biological specimen" in section 1206(a)(1) of the Business and Professions Code. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1209, 1225, 1241, 1244, 1269, 1288, 1288.5 and 1320, Business and Professions Code. s 1029.160. State License. "State license" or "license" means the license identified in section 1265(a)(1) of the Business and Professions Code. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5, Business and Professions Code. s 1029.165. State Registration. "State registration" or "registration" means the registration identified in section 1265(a)(2) of the Business and Professions Code. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5, Business and Professions Code. s 1029.168. Statement of Issues. "Statement of issues" means a written statement served on the person, entity or laboratory which: (a) Specifies the statutes and regulations with which the person, entity or laboratory must show compliance by producing proof at the hearing, and (b) Includes any particular matters which have come to the attention of the department that could form the basis for a denial of the departmental action sought. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 1326, Business and Professions Code; Sections 11503 and 11504, Government Code; and Section 14123, Welfare and Institutions Code. s 1029.169. Subspecialty of Histocompatibility. "Subspecialty of histocompatibility" means those clinical laboratory analyses of factors that determine the acceptance or rejection of grafted tissues or organs and that are performed in a histocompatibility laboratory as specified in Section 493.1265 of Title 42, Code of Federal Regulations, as published October 1, 1994. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1209.1 and 1210, Business and Professions Code. s 1029.170. Temporary Suspension of a License, Registration or Approval. Note: Authority cited: Section 1224, Business and Professions Code; and Sections 1002 and 100275, Health and Safety Code. Reference: Stats. 1995, c. 510, Section 1; Section 1323, Business and Professions Code; and Section 1002, Health and Safety Code. s 1029.171. Technical Supervisor. "Technical supervisor" means a person who meets the qualifications of Section 493.1449 of Title 42, Code of Federal Regulations, as published October 1, 1994, and who provides technical supervision in accordance with Section 1036.4 of this title and Section 493.1451 of Title 42, Code of Federal Regulations, as published October 1, 1994. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209, 1209.1 and 1210, Business and Professions Code. s 1029.173. Temporary Suspension of a License, Registration or Approval. "Temporary suspension of a license, registration or approval" means immediate suspension or limitation of a public health laboratory's approval to perform testing or a clinical laboratory's license or registration to perform tests or examinations in one or more, or all, specialties or subspecialties, prior to a hearing, based on a departmental finding of immediate jeopardy. Note: Authority cited: Section 1224, Business and Professions Code; and Sections 1002 and 100275, Health and Safety Code. Reference: Stats. 1995, c. 510, Section 1; Section 1323, Business and Professions Code; and Section 1002, Health and Safety Code. s 1029.175. Temporary Suspension of a Provider of Service Under the Medi-Cal Program. "Temporary suspension of a provider of service under the Medi-Cal program" means the immediate suspension imposed by the department pursuant to 22 CCR 51529(g) under the procedures identified in section 1067.15. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section 1; Section 14123, Welfare and Institutions Code; 42 United States Code; Section 1395w-2 (Section 1846 of the federal Social Security Act); and 42 United States Code, Section 1396a(a)(9) (Section 1902(a)(9)(C) of the federal Social Security Act). s 1029.180. Test Purposes. "Test purposes," as it relates to arterial puncture, venipuncture, and skin puncture, means withdrawal, or injection of any test materials specifically required for a clinical laboratory test, provided that appropriate instructions relative to injection technique have been given and that a licensed physician and surgeon is immediately available when test materials are injected. Unlicensed personnel may not inject test material for any purpose. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6 and 1246, Business and Professions Code. s 1029.185. Testing Event. "Testing event" means the performance of the preanalytical, analytical, and postanalytical activities related to performing a clinical laboratory test or examination on a biological specimen. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241, 1244, 1265, 1281, 1288.5 and 1300, Business and Professions Code. s 1029.190. Unprofessional Conduct. "Unprofessional conduct," pursuant to the provisions of Section 1320(m), Business and Professions Code, means: (a) Acts of gross negligence in the performance of duties authorized by the license under chapter 3, division 2, Business and Professions Code. (b) Acts of gross incompetence in the performance of duties authorized by the license under chapter 3, division 2, Business and Professions Code. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1320, Business and Professions Code. s 1029.195. Venipuncture. "Venipuncture" means the penetration of a vein with a needle to withdraw blood for clinical laboratory test or examination purposes. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1029.196. Waived Laboratory Supervisor. "Waived laboratory technical consultant" means a person who meets the qualifications specified in Section 1036.3(a) or (c) and provides technical oversight of a laboratory only performing waived tests. Note: Authority cited: Sections 1208 and 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code. s 1029.197. Waived Tests. "Waived tests" mean those clinical laboratory tests or examinations classified as waived under CLIA. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1203, 1204, 1206, 1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code. s 1030. Examination for Bioanalysts' Licenses. (a) The examination for license as a clinical laboratory bioanalyst shall consist of three sections; namely, written, oral, and practical. The subjects covered in this examination shall have to do with the technical procedures performed in clinical laboratories for the purpose of obtaining scientific data which may be used to ascertain the presence, progress, and source of disease. (b) An official transcript of college or university training shall be furnished by each applicant. The college or university training shall include as a minimum the indicated number of semester or equivalent quarter units of standard resident courses or their subject equivalent as follows: General inorganic chemistry.... 8 Quantitative analysis.......... 3 Organic chemistry.............. 3 Biochemistry................... 8 Bacteriology................... 8 Physics........................ 3 Biology or zoology............. 4 Physiology..................... 3 Parasitology................... 3 Hematology..................... 2 Note: Authority cited for Group 2: Section 208, Health and Safety Code, and Sections 1220 through 1223, Business and Professions Code. Additional authority cited: Section 102, Health and Safety Code. s 1030.5. Licensure of Clinical Chemists, Clinical Microbiologists, Clinical Toxicologists, Clinical Genetic Molecular Biologists and Clinical Cytogeneticists. A written and oral examination shall be given to each applicant for licensure as a clinical chemist, clinical microbiologist, clinical toxicologist, clinical genetic molecular biologist or clinical cytogeneticist. In addition to the requirements for licensure as specified in Section 1264 of the Business and Professions Code, an applicant shall have completed one year of training as a licensed trainee or equivalent in his or her specialty or subspecialty pursuant to Section 1207 of the Business and Professions Code. Also, each applicant shall have completed three years of experience in his or her specialty pursuant to Section 1210 of the Business and Professions Code in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in that specialty, two years of which shall have been at a supervisory level. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1204, 1205, 1207, 1210, 1264 and 1265, Business and Professions Code. s 1030.6. Licensure of Clinical Cytogeneticists. (a) Except for a clinical laboratory bioanalyst licensed by the department who meets the laboratory director qualifications for high complexity testing in Section 493.1443 of Title 42, Code of Federal Regulations, as published October, 1994, or a pathologist who meets the laboratory director qualifications in Section 493.1443(b)(1) of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of a clinical laboratory that performs tests or examinations in the subspecialty of clinical cytogenetics within the specialty of genetics shall possess a valid clinical cytogeneticist license issued by the department. (b) In order to be eligible for licensure as a clinical cytogeneticist, an applicant shall: (1) Be a physician and surgeon licensed by the State to practice medicine pursuant to Chapter 5 of the Business and Professions Code, and have: (A) Two years' training in clinical cytogenetics in a training program approved by the American Board of Medical Genetics (ABMG) or the Canadian Council of Medical Genetics (CCMG), and approved by the department pursuant to Section 1286, Business and Professions Code, Chapter 3, and (B) Two years' experience directing or supervising high complexity testing in the specialty of genetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and (C) Evidence of satisfactory performance on a written examination in clinical cytogenetics administered by the ABMG, CCMG or the department; and (D) Demonstrated satisfactory performance on an oral examination regarding Business and Professions Code, Chapter 3, and Title 42, CFR, Part 493, as published October 1, 1994; or (2) Hold an earned doctoral degree in a biological science or field related to genetics from an accredited university with thirty semester or equivalent quarter hours of post-baccalaureate course credit in genetics posted on an official transcript from the university registrar; and (A) Have two years' training in clinical cytogenetics in a training program approved by the ABMG or the CCMG, and approved by the department pursuant to Section 1286, Chapter 3, of Business and Professions Code; and (B) Have two years' experience supervising or performing clinical laboratory tests or examinations in clinical cytogenetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and (C) Provide evidence of satisfactory performance on a written examination in clinical cytogenetics administered by the ABMG, CCMG or the department; and (D) Have demonstrated satisfactory performance on the oral examination administered by the Department regarding Business and Professions Code, Chapter 3, and Title 42 Code of Federal Regulations, Part 493, as published October 1, 1994; or (3) Have served as a laboratory director of a clinical laboratory performing laboratory tests limited to the subspecialty of cytogenetics on or before December 31, 1997 and either; (A) Meet the laboratory director qualifications of Section 493.1443(b)(2) or (b)(3) of Title 42, Code of Federal Regulations, as published October 1, 1994; or (B) Hold an earned doctoral degree, have four years' clinical cytogenetics training or experience in a clinical laboratory certified by HCFA in clinical cytogenetics, and provide evidence of satisfactory performance on a written certifying examination in cytogenetics administered by the ABMG or the CCMG. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and 1282, Business and Professions Code. s 1030.7. Licensure of Clinical Genetic Molecular Biologists. (a) Except for a clinical laboratory bioanalyst licensed by the department pursuant to Business and Professions Code, Chapter 3, who meets the laboratory director qualifications for high complexity testing in Section 493.1443 of Title 42, Code of Federal Regulations, as published October, 1994, and a pathologist who meets the laboratory director qualifications in Section 493.1443 of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of a clinical laboratory that performs tests or examinations in the subspecialty of molecular biology related to the diagnosis of abnormalities related to human genetic disorders shall possess a valid clinical genetic molecular biologist license issued by the department. (b) In order to be eligible for licensure as a clinical genetic molecular biologist, an applicant shall: (1) Be a physician and surgeon licensed by the State, pursuant to Chapter 5 of the Business and Professions Code, to practice medicine and have: (A) Two years of training in clinical genetic molecular biology in a training program approved by the American Board of Medical Genetics (ABMG) or the Canadian Council of Medical Genetics (CCMG), and approved by the department pursuant to Section 1286, Chapter 3 of the Business and Professions Code; and (B) Two years' experience directing or supervising high complexity testing in the specialty of genetics in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and (C) Evidence of satisfactory performance on a written examination in genetic molecular biology administered by the ABMG or CCMG or the department; and (D) Demonstrated satisfactory performance on an oral examination administered by the department regarding Chapter 3 of the Business and Professions Code and Part 493 of Title 42, Code of Federal Regulations, as published October 1, 1994; or (2) Hold an earned doctoral degree in a biological science or field related to genetics from an accredited university with 30 semester or equivalent quarter hours of post-baccalaureate course credit in genetics posted on an official transcript from the university registrar; and (A) Have two years' training in clinical genetic molecular biology in a training program approved by the ABMG or the CCMG, and approved by the department pursuant to Section 1286, Chapter 3 of Business and Professions Code; and (B) Have two years' experience supervising or performing clinical laboratory tests or examinations in clinical genetic molecular biology in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing; and (C) Provide evidence of satisfactory performance on a written certifying examination in genetic molecular biology administered by the ABMG or CCMG or the department; and (D) Have demonstrated satisfactory performance in the oral examination regarding Chapter 3 of Business and Professions Code and Part 493 of Title 42 Code of Federal Regulations as published October 1, 1994; or (3) Have served as a laboratory director of a clinical laboratory performing laboratory tests limited to the subspecialty of molecular biology related to the diagnosis of human genetic abnormalities on or before December 31, 1997, and either: (A) Meet the qualifications of Section 493.1443(a), (b)(2), or (b)(3) of Title 42, Code of Federal Regulations, as published October 1, 1994; or (B) Hold an earned doctoral degree, have four years' clinical genetic molecular biology training or experience in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the subspecialty of molecular biology, and provide evidence of satisfactory performance on a written certifying examination in genetic molecular biology administered by the ABMG or CCMG. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and 1282, Business and Professions Code. s 1030.8. Licensure of Oral Pathology Laboratory Directors. (a) Except for a pathologist who meets the laboratory director qualifications of Section 493.1443(b)(1) of Title 42, Code of Federal Regulations, as published October 1, 1994, a laboratory director of an oral pathology laboratory shall possess a valid oral pathology laboratory director license issued by the department. (b) In order to be eligible for licensure as an oral pathology laboratory director, an applicant shall: (1) Be a doctor of dental surgery licensed by the State pursuant to Chapter 4 of the Business and Professions Code to practice dentistry, and have: (A) Advanced training in oral and maxillofacial pathology in a training program approved by the American Dental Association (ADA) Committee on Accreditation of Dental and Dental Auxiliary Education Programs in an educational institution; and (B) Full time experience in oral pathology which, together with advanced training approved by the ADA, shall total a minimum of four years; and (C) Evidence of satisfactory performance on the oral pathologist certification examination administered by the American Board of Oral Pathology (ABOP); and (D) Demonstrated satisfactory performance on an oral (verbal) examination administered by the department regarding Chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 as published October 1,1994; or (2) Have served as a laboratory director of an oral pathology laboratory on or before January 1, 1996, and be a doctor of dental surgery licensed by the State pursuant to Chapter 4 of the Business and Professions Code to practice dentistry, and provide evidence of satisfactory performance on a certifying examination in oral and maxillofacial pathology administered by the ABOP. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1207, 1208, 1209 and 1264, Business and Professions Code. s 1031. Licensure of Clinical Laboratory Specialists. (a) The minimum requirements for admission to the limited scientist examinations shall be as follows: (1) An applicant for admission to the examination for a clinical chemist scientist license shall meet both of the following requirements: (A) Hold a baccalaureate or higher degree in chemistry or equivalent major which shall include at least 25 semester or 38 quarter units in chemistry including courses in analytical chemistry and instrumentation. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and (B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of chemistry, as listed in (b)(1) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of chemistry. (2) An applicant for admission to the examination for a clinical microbiologist scientist shall meet both of the following requirements: (A) Hold a baccalaureate or higher degree in microbiology or an equivalent major which shall include at least 25 semester or 38 quarter units in microbiology including courses in medical or pathogenic microbiology or bacteriology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and (B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of microbiology, as listed in (b)(2) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology. (3) An applicant for admission to the examination for a clinical immunohematologist scientist license shall meet both of the following requirements: (A) Hold a baccalaureate or higher degree in biology, clinical laboratory science or equivalent major which shall include at least 25 semester or 38 quarter units in biology, including genetics and immunology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and (B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of immunohematology, as listed in (b)(3) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of immunohematology. (4) An applicant for admission to the examination for clinical toxicologist scientist license shall meet both of the following requirements: (A) Hold a baccalaureate or higher degree in chemistry or equivalent major which shall include at least 25 semester or 38 quarter units in chemistry including analytical chemistry or quantitative analysis. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by a college or university from an accredited college or university; and (B) Have completed one year of post-baccalaureate training or experience in the specialty of toxicology, as specified in (b)(4) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the subspecialty of toxicology. (5) An applicant for admission to the examination for a clinical hematologist scientist license shall meet both of the following requirements: (A) Hold a baccalaureate degree from an accredited college or university in biology, clinical laboratory science or an equivalent major which shall include at least 25 semester or 38 quarter units in biology, including hematology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and (B) Have one year of post-baccalaureate training or experience in all areas of the specialty of hematology, as specified in (b)(5) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of hematology. (b) Any license issued under this section shall specify the particular specialty or subspecialty in which the licentiate may perform tests under such license. A license issued for: (1) A clinical chemist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA in the specialty or subspecialties of chemistry, including routine chemistry, clinical microscopy, endocrinology and toxicology; immunology, including diagnostic immunology and syphilis serology; and molecular biology. (2) A clinical microbiologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA in the specialty or subspecialties of microbiology including bacteriology, mycobacteriology, mycology, parasitology, and virology; immunology, including diagnostic immunology and syphilis serology; and molecular biology. (3) A clinical immunohematologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the specialty of immunohematology including ABO/Rh Type or Group, unexpected antibody detection, compatibility testing and antibody identification. (4) A clinical toxicologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the subspecialty of toxicology. (5) A clinical hematologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the specialty of hematology including routine hematology and coagulation. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1209.1, 1210 and 1261, Business and Professions Code. s 1031.1. Licensure of Clinical Histocompatibility Scientists. (a) Each person performing high complexity laboratory tests or examinations in the subspecialty of histocompatibility in a licensed clinical laboratory shall possess a valid clinical histocompatibility scientist license except for the following persons: (1) A physician and surgeon licensed by the State to practice medicine pursuant to chapter 5 of the Business and Professions Code; or (2) A histocompatibility laboratory director licensed pursuant to chapter 3 of the Business and Professions Code; or (3) A clinical laboratory bioanalyst licensed pursuant to chapter 3 of the Business and Professions Code; or (4) A clinical laboratory scientist licensed pursuant to chapter 3 of the Business and Professions Code. (b) In order to be eligible for licensure as a clinical histocompatibility scientist an applicant shall have been certified as a Clinical Histocompatibility Technologist by the American Board of Histocompatibility and Immunogenetics, either: (1) Prior to January 1, 1997 and have had at least 6 years' experience in all areas of clinical histocompatibility testing in a clinical laboratory, or (2) After January 1, 1997 and have a baccalaureate degree in biological or clinical science and one year of clinical laboratory experience in all areas of clinical histocompatibility testing in a clinical laboratory. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1209.1, 1210 and 1261, Business and Professions Code. s 1031.2. Licensure of Clinical Cytogeneticist Scientists. (a) Each person performing high complexity tests or examinations in the specialty of cytogenetics in a licensed clinical laboratory shall possess a valid clinical cytogeneticist scientist license except for the following persons: (1) A physician and surgeon licensed by the State to practice medicine pursuant to chapter 5 of division 2 of the Business and Professions Code; or (2) A clinical cytogeneticist licensed to direct a cytogenetics laboratory pursuant to chapter 3; or (3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or (4) A clinical laboratory scientist licensed pursuant to chapter 3. (b) In order to be eligible for licensure as a clinical cytogeneticist scientist, an applicant shall: (1) Hold a baccalaureate or an equivalent or higher degree, which shall include at least 25 semester or 38 quarter hours in biology, chemistry or clinical laboratory science from an accredited college or university, and (2) Provide evidence of satisfactory performance on a written examination in the specialty of cytogenetics administered by the National Credentialing Agency for Laboratory Personnel (NCA), and either: (A) On or after March 14, 2003, have completed at least one year training and/or experience in clinical cytogenetics in a clinical laboratory certified by the Centers for Medicare and Medicaid Services (CMS) in clinical cytogenetics. This training shall be approved by the department pursuant to Section 1035 and acceptable for admission to an examination by the NCA in the specialty of cytogenetics; or (B) Prior to March 14, 2003, have completed training and/or experience in clinical cytogenetics, which is acceptable for admission to an examination by the NCA in the specialty of cytogenetics, in a clinical laboratory certified by CMS in clinical cytogenetics or in histopathology (cytogenetics). Note: Authority cited: Sections 1224, 1261 and 1261.5, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1205, 1206, 1206.5, 1210, 1222.5, 1261, 1261.5, 1262, 1282 and 1286, Business and Professions Code. s 1031.3. Licensure of Clinical Genetic Molecular Biologist Scientists. (a) Each person performing high complexity tests or examinations in the subspecialty of genetic molecular biology in a licensed clinical laboratory shall possess a valid clinical genetic molecular biologist license except for the following persons: (1) A physician and surgeon licensed by the State to practice medicine pursuant to chapter 5 of division 2 of the Business and Professions Code; or (2) A clinical genetic molecular biologist licensed to direct a genetics laboratory pursuant to chapter 3; or (3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or (4) A clinical laboratory scientist licensed pursuant to chapter 3. (b) In order to be eligible for licensure as a clinical genetic molecular biologist scientist, an applicant shall hold a baccalaureate or an equivalent or higher degree in a biological or clinical laboratory science, or field related to genetics from an accredited college or university; and (1) Have completed at least one year training and/or experience in clinical genetic molecular biology in a clinical laboratory certified by the Center for Medicare & Medicaid Services (CMS), performing high complexity testing in clinical genetic molecular biology. This training and/or experience shall be acceptable for admission to an examination by the National Credentialing Agency for Laboratory Personnel (NCA) in the specialty of molecular biology. On or after March 14, 2003, this training shall be approved by the department pursuant to Section 1035; and (2) Provide evidence of satisfactory performance on a written examination in molecular biology administered by the NCA. Note: Authority cited: Sections 1224, 1261 and 1261.5, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1205, 1206, 1206.5, 1210, 1222.5, 1261, 1261.5, 1262, 1282 and 1286, Business and Professions Code. s 1031.4. Requirements and Timeframes for Applications for Licensure and Certification. (a) Applications for admission to a state-administered licensing examination shall be complete when the information specified in Section 1031.4(b) has been received by the department. For an applicant to be eligible for a scheduled examination, the completed application must be postmarked at least 120 days prior to the examination date as published by the Department of Health Services. When applying for admission to the examination, the applicant shall state whether he or she has previously applied to the department for admission to an examination. (b) An application for licensure to direct a clinical laboratory or to perform clinical laboratory tests or examinations under Chapter 3 shall be considered complete when the following is provided to the department: (1) Name and address of the applicant, including city, state and zip code; and (2) Social security number of the applicant (Pursuant to the authority found in Section 1224 of the Business and Professions Code and in Section 100275 of the Health and Safety Code, and as required by Section 17520 of the Family Code, it is mandatory to provide the social security number. The social security number will be used for purposes of identification.); and (3) Gender and birthdate; and (4) License for which the applicant is applying; and (5) Whether the applicant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations; and (6) Documentation of the applicant's education including: (A) Name, address, major course of study, dates of attendance, number of credits, and degree/completion date for all colleges and universities attended by the applicant; and (B) Official transcripts from the registrar of all accredited colleges or universities attended by the applicant showing all courses, course credits, degrees conferred and date of conference; and (C) Official transcripts from non-United States colleges or universities which are not in English shall be returned to the applicant to obtain translation from a translation service approved in the United States for legal or government documents. (7) Documentation of the applicant's training including: (A) Name and address of training program, dates of training, specialty and subspecialty areas of training, length of time in each specialty and subspecialty area of training; and (B) Signed documentation from the training program director that this training has been successfully completed; and (8) Documentation of the applicant's experience, appropriate to the specific license for which the applicant is applying, including the following: (A) Facility name, address, dates of employment, number of hours per week employed, the specialties and subspecialties in which clinical laboratory tests or examinations were performed and a description of clinical laboratory tests or examinations performed; and (B) Signed documentation of such experience from the director of the laboratory; and (9) Evidence of satisfactory performance on a licensing examination pursuant to Section 1029.81; and (10) Signature of the applicant, telephone number and date of application; and (11) Payment of license application fee pursuant to Business and Professions Code Section 1300. (c) An application for certification in phlebotomy shall be considered complete when the following is provided to the department: (1) Name and address of the applicant, including city, state and zip code; and (2) Social security number of the applicant (Pursuant to the authority found in Section 1224 of the Business and Professions Code and in Section 100275 of the Health and Safety Code, and as required by Section 17520 of the Family Code, it is mandatory to provide the social security number. The social security number will be used for purposes of identification.); and (3) Gender and birthdate; and (4) Category of phlebotomy certification for which the applicant is applying; and (5) Whether the applicant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations; and (6) Documentation of the applicant's education including: (A) Name, address, dates of attendance, coursework completed and graduation as verified by official school transcripts; or (B) Documentation of a passing score on the general educational development (GED) test or equivalent education as evaluated by the American Association of Collegiate Registrars and Admissions Officers for secondary education; or (C) For official school transcripts which are not in English, documentation of equivalent education as obtained through translation into English from a translation service approved in the United States for legal or government documents; and (7) Certification of the applicant's instruction in phlebotomy as specified in Section 1035.1(h); and (8) Certification of the applicant's on-the-job experience in phlebotomy, if applicable, including: (A) Name and address of laboratory where employed, dates of employment, number of hours of experience in techniques specified in Section 1035.1(f) and an estimate of the number of skin punctures, venipunctures or arterial punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfills all the sampling requirements of all clinical laboratory tests or examinations; and (B) Signed documentation from the director of the laboratory that the above information accurately represents the applicant's experience in phlebotomy; and (9) Evidence of satisfactory performance on a certification examination in phlebotomy administered by a certifying organization that was approved by the department pursuant to Section 1031.7 at the time the examination was administered; and (10) Signature of the applicant, telephone number and date of application; and (11) Payment of a two-year certification fee of $50. (d) Timeframes for processing applications for licensure to direct a clinical laboratory or to perform clinical laboratory tests or examinations or for certification to perform phlebotomy pursuant to Chapter 3 shall be as follows: (1) The department shall notify the applicant in writing, within 90 days of receipt of an application, of one of the following: (A) The application is complete and will be processed by the department; or (B) The application is incomplete and not accepted for processing. The department's written notification shall include the specific information, documentation or fee in which the application is deficient; or (C) The application has been reviewed and does not meet the requirements and that approval is denied. The department shall give written notification of the basis for the denial. (2) The department shall notify the applicant within 90 days of postmark date of resubmission of application requirements pursuant to Section 1031.4(d)(1)(B) whether the application has been approved or denied. (3) Written notification by the department to applicants shall be deemed to occur on the date of the postmark from the department. (4) The department shall deem an application abandoned by an applicant who fails to respond or to supply all information, documents, verifications or payment of applicable fees within 30 days of notification by the department. (5) The department's time periods for processing an application for licensure or certification from the date the application is complete to the date the final decision is made regarding an approval are as follows: (A) The median time for processing an application is 90 days; (B) The minimum time for processing an application is 30 days; and (C) The maximum time for processing an application is 150 days. (e) Certification shall be valid for a period of 2 years unless revoked. (f) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department. (g) All applicants, licensees and certificants pursuant to Section 1031.4 shall notify the department in writing of any change(s) of name and /or address within 30 days after the change(s) has occurred. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 17520, Family Code. Reference: Sections 1203, 1204, 1205, 1207, 1209, 1209.1, 1210, 1220, 1241, 1242, 1242.5, 1246, 1260, 1261, 1261.5, 1263, 1264, 1282, 1300, 1301, 1301.1 and 1320, Business and Professions Code; Section 120580, Health and Safety Code; and Section 15376, Government Code. s 1031.5. Requirements and Timeframes for Renewal of Licenses and Certificates. (a) In order to maintain a license in active status, licenses shall be renewed by filing a renewal application within 60 days prior to the end of the license period. (b) A complete license renewal application shall include name and address of the licensee, license number, current work location(s), documentation of continuing education credits, an attestation stating whether the licensee has or has not been convicted of any felonies or misdemeanors other than minor traffic violations in the previous two years, license renewal fee, signature and date of application for renewal. (c) In order to maintain a phlebotomy certificate in active status, certificates once approved shall be renewed at biennial intervals by filing a renewal application within 60 days prior to the end of the certificate period. (d) A complete phlebotomy certificate renewal application shall include name and address of the certificant, certificate number, current work location(s), documentation of continuing education performed during the previous 24 months, an attestation stating whether the certificant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations in the previous two years, certification renewal fee of $50, signature and date of application for renewal. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1205, 1207, 1209, 1209.1, 1210, 1226, 1241, 1242, 1242.5, 1246, 1260, 1261, 1261.5, 1263, 1264, 1282, 1300, 1301 and 1301.1, Business and Professions Code; and Section 120580, Health and Safety Code. s 1031.7. Conditions for Approval of Certifying Organizations to Administer Phlebotomy Certification Examinations. (a) In order for a certifying organization to be eligible for approval by the department to administer a phlebotomy certification examination for state certification purposes, the certifying organization shall meet the following conditions: (1) The certifying organization shall be a national, independent, not-for-profit, professional certifying organization; and (2) The certifying organization shall offer examinations in phlebotomy; and (3) The certifying organization shall provide the following to the department: (A) The organization's name and address; and (B) Names of the organization's officers and board of directors; and (C) A description of the organization's structure; and (D) The identity of the person designated by the organization to be responsible for overseeing the administration and coordination of all examination activities; and (E) A schedule of dates and times that the examination will be conducted within the state; and (F) Listing of procedures for monitoring the content, quality, validity and relevance of the phlebotomy examinations pursuant to Section 1031.7 (b); and (G) The philosophy of the organization, demonstrating a commitment to accurate assessment of a candidate's preparation for phlebotomy certification. (b) In order for a certifying organization's examination to be approved for certification purposes, the organization shall document the following standards to support a request for approval: (1) Evaluation of relevant standards in phlebotomy and how the organization's examinations address knowledge and skills that would assure competence of the candidate; and (2) Explanation of how the examinations are developed by the organization and the qualifications of person(s) who develop the examination questions; and (3) Documentation that the organization's examinations are subject to annual review for current relevance; and (4) Demonstration of the ability of the organization to evaluate its examinations, subjecting the examinations to validity and reliability assessments using psychometric performance standards, and the capability of the organization to provide this information at least once yearly or upon request to the department. (c) An organization approved to administer a phlebotomy examination shall: (1) Agree to make the content of its examinations available to the department for confidential review; and (2) Demonstrate how it will maintain security during administration of the examination, ensure the identity of the examinee, and maintain the confidentiality of the examination; and (3) Document how it will make its records accessible to the department regarding those persons participating in the examination and their scores; and (4) Provide verification of those persons successfully passing the certification examination to the department and shall maintain these records for five years; and (5) Issue a certificate to those passing the examination with the examinee's name, name of the certifying organization, type of certificate, effective date and official signature. (d) Timeframes for processing applications for approval of a certifying organization's certification examination shall be as follows: (1) Within 90 calendar days of receipt of an application, the department shall inform the organization in writing that the application is either complete and accepted for review or that it is deficient and what specific information or documentation is required to complete the application. (2) Within 180 calendar days from the date of filing a completed application, the department shall inform the applicant certifying organization in writing whether the organization has been approved or denied as a certifying organization for the administration of the certification examination. (3) The department shall deem an application abandoned by an applicant certifying organization that fails to respond or to supply all information, documents, or verifications within 30 days of notification pursuant to Section 1031.7(d)(1). (4) The department's time periods for processing an application for approval as a certifying organization, from the receipt of the initial application to the final decision regarding the approval, are as follows: (A) The median time for processing is 180 calendar days. (B) The minimum time for processing is 90 calendar days. (C) The maximum time for processing is 360 calendar days. (e) Approval shall be valid for a period of four years unless revoked. (f) To apply for renewal, a certifying organization shall file a renewal application at least 120 days prior to the end of the approval period providing the following: (1) The name and address of the certifying organization; and (2) Names of the organization's officers and board of directors; and (3) Name of the person designated by the organization to be responsible for overseeing the administration and coordination of all examination activities; and (4) A schedule of dates and times that the examination will be conducted within the state for the next 12 months; and (5) A copy of the current examination; and (6) Signature of the program director and date of application for renewal. (g) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department. (h) A certifying organization shall notify the department in writing of any change(s) in the information and material required by Subsections (a) through (c) within 30 days after the change(s) has occurred. Note: Authority cited: Sections 1224 and 1320, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1031.8. Conditions for Approval of a Certifying Organization to Administer a Certifying Examination for Licensure Purposes. (a) In order for a certifying organization to be eligible for approval by the department to administer a category of certifying examination, the organization shall file a complete application that consists of the following: (1) Documentation that the certifying organization is a national, independent, not-for-profit, professional certifying organization; and (2) The organization's name and address; and (3) Names of the organization's officer(s) and board of directors; and (4) Description of the organization's structure and organizational chart; and (5) The identity of the person designated by the organization to be responsible for overseeing the administration and coordination of examination activities; and (6) A mission statement that demonstrates the philosophy of the certifying organization commits to an accurate assessment of a candidate's preparation in the clinical laboratory science category in which the candidate is examined; and (7) Schedule of dates that the examination will be available to California licensure applicants during the next four years; and (8) Listing of procedures for monitoring the content, quality, validity, reliability and relevance of the examination in the specialty being tested, and (9) Demonstration of how the organization's examination addresses the relevant standards in the clinical laboratory science category being examined, and how it evaluates the knowledge and skills that would assure competence of the candidate; and (10) Explanation of how the examination structure is developed by the organization, and the qualifications of person(s) who develop the examination questions; and (11) Documentation that the organization's examination is subject to annual review for current relevance; and (12) Demonstration of the ability of the organization to evaluate its examination, subjecting it to validity and reliability assessments using psychometric performance standards, and the capability of the organization to provide this information at least annually or upon request to the department; and (13) Explanation of how the examination is developed and weighted using a job task survey to determine knowledge and skills required to be competent in the examination category; and (14) Explanation of how examination questions are established, evaluated and updated to match current practice for the category; and (15) Explanation of how the cutoff score for those successfully passing the examination is determined; and (16) Documentation of performance statistics for the examination during the previous five years, including pass/fail rate, number of applicants and number accepted to the examination for each time that the examination has been administered by the certifying organization during the five years immediately prior to the date of application, or, for specialties that have been established for less than five years, during the period dating from the establishment of the specialty to the date of the application; and (17) Submission of printed copies of examinations given each year for the previous four years, if the examinations were offered. These examination shall be subject to confidential review by the department, shall not be copied, and shall be returned to the organization; and (18) Submission of an agreement to provide the examination to candidates who have been approved for admission to the examination by the department; and (19) Submission of an agreement to provide verification of those persons successfully passing the examination to the department and to maintain these records for five years; and (20) Submission of an agreement to give evidence of satisfactory performance as official notification to those passing the examination with the examinee's name, name of the certifying organization, examination category, effective date and official signature; and (21) Demonstration how the organization will maintain security during development and administration of the examination, ensure the identity of the examinee, and maintain the confidentiality of the examination; and (22) Listing of procedures in use and required of the organization's personnel to ensure security and confidentiality of the examination, and steps to be taken if a breach is discovered; and (23) An agreement that a breach of security shall be reported to the department and that the department is authorized to investigate and withdraw approval of the examination category; and (24) Documentation how the organization will make its records accessible to the department regarding those persons participating in the examination and their scores; and (25) The name, title, and signature of the person who is responsible for overseeing the administration and coordination of all examination activities, and the date the application was signed. (b) Initial approval of an organization's examination category shall include confidential review of an examination given each year up to four years immediately preceding the date of approval, so that examinations taken during this time shall be acceptable for licensure purposes. (c) Timeframes for processing applications for approval of a certifying organization's examination in a clinical laboratory science category for licensure purposes shall be as follows: (1) The department shall notify the applicant organization within 90 days of submission of an application of one of the following: (A) That the application is complete and acceptable for processing by the department; or (B) That the application is incomplete and not accepted for processing. This notification shall include the specific information or documentation that the applicant shall submit within 30 days in order for the department to consider the application acceptable; or (C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied. (2) The department shall consider an application to have been abandoned by any applicant who fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1031.8(c)(1)(B). (d) Written notification by the department to the applicant organization shall be considered to occur on the date the documents are postmarked, (e) A certifying organization shall notify the department in writing of any change in the information and materials required by this section within 30 days after the change has occurred. (f) Failure to meet and maintain the requirements of this section shall be good cause for denial or revocation of approval by the department. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1228, 1261, 1261.5, 1262, 1263 and 1264, Business and Professions Code. s 1031.9. Conditions for Renewal of a Certifying Organization's Approval to Administer Examinations Acceptable for Licensure Purposes. (a) Approval of a certifying organization shall be valid for a period of four years unless revoked. At least 120 days prior to the end of the approval period, the certifying organization that wants to continue approval of its examination shall apply for reapproval. Failure to reapply 120 days in advance shall cause a lapse in approval after which time the examination would not be acceptable for licensure purposes until the certifying organization regains approval. A certifying organization that fails to reapply at least 120 days in advance and subsequently elects to seek approval shall make application pursuant to Section 1031.8. (b) To apply for renewal of a certifying organization's approval to administer examinations, the organization shall provide the following: (1) The name and address of the certifying organization; and (2) Names of the organization's officer(s) and board of directors; and (3) Name of the person designated by the organization to be responsible for overseeing the administration and coordination of all examination activities; and (4) A schedule of dates that the examination will be available to California applicants during the next four years; and (5) A summary of the performance statistics of the examination during the previous approval period, including the number of California applicants applying for, and successfully passing, the certifying examination, the applicant scores, what efforts have been made to evaluate the examination and update the examination questions to match current practice for the category; and (6) The name, title and signature of the person responsible for overseeing the administration and coordination of all examination activities and date of application for renewal. (c) The timeframes for processing an application of a certifying organization seeking renewal of its examination approval shall be as follows: (1) The certifying organization shall submit an application for renewal of approval of its examination at least 120 days prior to the end of the approval period. (2) Within 30 days of receipt of a renewal application, the department shall inform the organization in writing that the renewal application is complete and accepted for review, or deficient and what specific information or documentation is required to complete the application. (3) Within 30 days of receiving a completed renewal application, the department shall inform the applicant organization in writing whether the examination has been reapproved or denied. (d) Failure to meet and maintain the requirements of this section shall be good cause for denial of reapproval by the department. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1228, 1261, 1261.5, 1262, 1263 and 1264, Business and Professions Code. s 1032. Examination for Clinical Laboratory Technologist's License. With the exception as provided in Section 1262 of the Business and Professions Code, written, oral, or practical examinations shall be conducted by the department to aid it in judging the qualifications of applicants for licensure as clinical laboratory technologists. In addition to the requirements for licensure as specified in Section 1261 of the Business and Professions Code, the prerequisites for entrance into the licensing examination shall be one of the following: (a) Graduation from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges, or an essentially equivalent accrediting agency, with a baccalaureate and a major in clinical laboratory science, the last year of which course shall have been primarily clinical laboratory procedures in a clinical laboratory training school acceptable to the department; or (b) Graduation from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Eastern Association of Schools and Colleges, or an essentially equivalent accrediting agency, with a baccalaureate and courses pertinent to the clinical laboratory field as may be determined by the department plus one year as a clinical laboratory technologist trainee or the equivalent as determined by the department in a clinical laboratory acceptable to the department; provided, however, that a baccalaureate obtained after July 1, 1973, must include at least: (1) 16 semester or equivalent quarter hours of chemistry, including instruction in analytical and biological chemistry; (2) 18 semester or equivalent quarter hours of biological science, including instruction in immunology, hematology and medical microbiology which may include bacteriology, mycology, virology and parasitology; (3) 3 semester or equivalent quarter hours of physics, including instruction in principles of light and electricity; or (c) A minimum of two years of experience as a licensed trainee or the equivalent as determined by the department doing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory acceptable to the department and 90 semester hours or equivalent quarter hours of university or college work in which are included the following coursed, or essential equivalent as may be determined by the department: general inorganic chemistry -8; quantitative analysis -3; basic biological sciences -8; bacteriology -4; provided, however, that university or college work completed after July 1, 1973, must include at least: (1) 16 semester or equivalent quarter hours of chemistry, including instruction in analytical and biological chemistry; (2) 18 semester or equivalent quarter hours of biological science including instruction in immunology, hematology and medical microbiology which may include bacteriology, mycology, virology and parasitology; (3) 3 semester or equivalent quarter yours of physics, including instruction in principles of light and electricity. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 1246, 1261, 1262, 1263, 2164 and 1301, Business and Professions Code. s 1032.5. Licensure of Medical Laboratory Technicians. (a) In order to qualify for licensure as a medical laboratory technician, a person shall apply for a license pursuant to Section 1031.4 (b) and meet the following requirements: (1) Have successfully completed at least 60 semester (90 quarter) units from an accredited college or university. The coursework shall consist of at least 36 semester units of physical and biological sciences with an emphasis on applied clinical science. Coursework shall include 6 semester units of chemistry and 6 semester units of biology appropriate for transfer to a baccalaureate program in science, taken prior to, or concurrently with, training or experience; and (2) Have met the following training or experience requirements by documenting one of the following: (A) Graduating from a medical laboratory technician training program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS); or (B) Graduating from a medical laboratory technician training program approved by the department pursuant to Section 1035.3; or (C) Meeting admission requirements for a clinical laboratory scientist licensing examination, as determined by the department pursuant to Section 1032; or (D) Completing a minimum of three years on-the-job practical experience within the previous five years, in a clinical laboratory outside California as a medical laboratory technician, with evidence of satisfactory performance on an examination given by a certifying organization for medical laboratory technicians, performing tests in the specialties of chemistry, hematology, microbiology, and immunology. This work experience shall include at least 480 hours in each of these specialties and shall be documented by the laboratory director(s) of the laboratory(ies) employing the applicant pursuant to Section 1031.4(b)(8); or (E) Completing a minimum of three years on-the-job practical experience within the previous five years, in a clinical laboratory outside California as a clinical laboratory scientist, with evidence of satisfactory performance on an examination given by a certifying organization for clinical laboratory scientists, performing tests in the specialties of chemistry, hematology, microbiology, and immunology. This clinical laboratory scientist, also called medical technologist in some states, need not be California licensed pursuant to Business and Professions Code section 1204, but shall have work experience outside California of at least 480 hours in each of these specialties as documented by the laboratory director(s) of the laboratory(ies) employing the applicant pursuant to Section 1031.4(b)(8); or (F) Completing a minimum of three years on-the-job practical experience within the previous five years, as a medical laboratory technician or clinical laboratory scientist in a California physician office laboratory or in a laboratory owned and operated by the United States of America. This person shall have evidence of satisfactory performance on an examination given by a certifying organization for medical laboratory technicians or clinical laboratory scientists, respectively, and have performed tests in the specialties of chemistry, hematology, microbiology and immunology. This work experience shall include at least 480 hours in each of these specialties, and shall be documented by the physician(s) directing the laboratory(ies) employing the applicant pursuant to Section 1031.4(b)(8); and (3) Have passed a written examination for medical laboratory technicians administered by a certifying organization for medical laboratory technicians approved by the department pursuant to Section 1031.8. The department shall, for licensure purposes, accept evidence of satisfactory performance on examinations taken within the four years previous to department approval of a certifying organization's medical laboratory technician examination. The applicant shall have also passed a separate written, self-administered examination on California clinical laboratory law provided by the department. This self-administered test shall accompany the application. A minimum passage rate of 70 percent shall be required. (b) A licensed medical laboratory technician shall be authorized to: (1) Perform tests and examinations classified as waived and moderate complexity by Centers for Disease Control and Prevention in the specialties of chemistry, including routine chemistry, urinalysis, endocrinology and toxicology; hematology including coagulation; microbiology, including bacteriology, mycobacteriology, mycology, parasitology and virology; and immunology, including syphilis serology and general immunology, with the exception of those moderate complexity tests requiring microscopy, or in the specialty of immunohematology. (2) Perform phlebotomy, but shall not perform skin tests for specific diseases pursuant to Section 1242 of the Business and Professions Code. (3) Perform tests and examinations under the supervision of a licensed physician and surgeon, or a doctoral scientist, clinical laboratory bioanalyst, clinical laboratory scientist, or clinical laboratory specialist licensed under Chapter 3. On-site supervision shall be required during the entire time the medical laboratory technician performs moderate complexity clinical laboratory tests or examinations. The ratio of medical laboratory technician to supervisor at the site of moderate complexity testing shall not exceed four to one. (4) Report test results and perform phlebotomy only after competency has been documented by the laboratory director pursuant to Section 1209(e) of the Business and Professions Code. (5) Supervise Limited Phlebotomy Technicians or Certified Phlebotomy Technician Is. (c) The license application fee and license renewal fee for a medical laboratory technician shall be the same as the license application fee and license renewal fee for a clinical laboratory scientist pursuant to Section 1300(c) and (e) of the Business and Professions Code. (d) A medical laboratory technician shall complete twelve hours of continuing education each year as a condition for renewal. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1204, 1206, 1206.5, 1208, 1209, 1210, 1242, 1260.3, 1261, 1275, 1300 and 1320, Business and Professions Code. s 1033. Trainee Requirements. In addition to the requirements for licensure as specified in Section 1263 of the Business and Professions Code, the prerequisites for licensure as a trainee shall be as follows: (a) Clinical Laboratory Technologist Trainee. Applicants shall have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent agency with a baccalaureate and a major in clinical laboratory science, or a baccalaureate and courses pertinent to the clinical laboratory field as may be determined by the department. An individual who is not a graduate but possesses at least 90 semester hours or equivalent quarter hours of university or college work may be licensed as a clinical laboratory technologist trainee, provided he will be granted a baccalaureate at the conclusion of 12 months of training, and have completed at least 90 semester hours or equivalent quarter hours, must have included in the college work the following courses or essential equivalent as may be determined by the department: general inorganic chemistry -8; quantitative analysis -3; basic biological sciences -8; bacteriology -4; provided, however, that university or college work completed after July 1, 1973, must include at least: (1) 16 semester or equivalent quarter hours of chemistry, including instruction in analytical and biological chemistry; (2) 18 semester or equivalent quarter hours of biological science, including instruction in immunology, hematology and medical microbiology which may include bacteriology, mycology, virology and parasitology; (3) 3 semester or equivalent quarter hours of physics including instruction in principles of light and electricity. (b) Limited Technologist Trainee. Applicants shall have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate and a major in the specialty for which licensure is sought. If the major is not designated by the college or university as one of those required under this chapter for limited technologist licenses in clinical chemistry, clinical microbiology, immunohematology, or toxicology, the department may determine the essentially equivalent major. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: sections 1246, 1261, 1262, 1263, 1264 and 1301, Business and Professions Code. s 1034. Certification of Phlebotomy Technicians. (a) The education, training and experience required for certification in phlebotomy shall be as follows: (1) For a person to be eligible for certification as a Limited Phlebotomy Technician, he or she shall: (A) Be a high school graduate or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and (B) Have completed a minimum of 20 hours basic didactic instruction pursuant to Section 1035.1(e)(1) from a phlebotomy training program approved by the department; and (C) Have completed a minimum of 25 skin punctures, performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations, in a clinical setting on patients, under the supervision of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, or licensed clinical laboratory scientist, who will certify in writing with a signed certificate that this training has been completed; and (D) Apply to the department for certification as a Limited Phlebotomy Technician pursuant to Section 1031.4(c). (2) For a person with no on-the-job experience in phlebotomy to be eligible for certification as a Certified Phlebotomy Technician I, he or she shall: (A) Be a high school graduate, or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and (B) Have completed a minimum of 40 hours didactic instruction pursuant to Section 1035.1(e) from a phlebotomy training program approved by the department; and (C) Have completed a minimum of 40 hours practical instruction from a phlebotomy training program approved by the department pursuant to Section 1035.1(f), which instruction shall include completion of a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations; and (D) Have passed a written examination in phlebotomy administered by a certifying organization approved by the department pursuant to Section 1031.7; and (E) Apply to the department for certification as a Certified Phlebotomy Technician I pursuant to Section 1031.4(c). (3) For a person who has less than 1040 hours on-the-job experience in phlebotomy to be eligible for certification as a Certified Phlebotomy Technician I, he or she shall: (A) Be a high school graduate or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and (B) Have completed a minimum of 40 hours didactic instruction pursuant to Section 1035.1(e) from a phlebotomy training program approved by the department; and (C) Have a letter signed by a licensed physician and surgeon or licensed clinical laboratory bioanalyst directing the laboratory employing the person attesting his or her completion of a specified number of hours of on-the-job experience in phlebotomy within the previous five years, which shall include the activities listed in Section 1035.1(f) and completion of a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations; and (D) Have passed a written examination in phlebotomy administered by a certifying organization approved by the department pursuant to Section 1031.7; and (E) Apply to the department for certification as a Certified Phlebotomy Technician I pursuant to Section 1031.4(c). (4) For a person who has 1040 hours or more of on-the-job experience in phlebotomy to be eligible for certification as a Certified Phlebotomy Technician I, he or she shall: (A) Be a high school graduate or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and (B) Have completed a minimum of 20 hours advanced didactic instruction pursuant to Section 1035.1(e)(2) from a phlebotomy training program approved by the department; and (C) Have a letter signed by a licensed physician and surgeon or licensed clinical laboratory bioanalyst directing the laboratory employing the person attesting his or her completion of a specified number of hours of on-the-job experience in phlebotomy within the previous five years which shall include the activities listed in Section 1035.1(f) and completion of a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations; and (D) Have passed a written examination in phlebotomy administered by a certifying organization approved by the department pursuant to Section 1031.7; and (E) Apply to the department for certification as a Certified Phlebotomy Technician I pursuant to Section 1031.4(c). (5) For a person to be eligible for certification as a Certified Phlebotomy Technician II, he or she shall: (A) Be a Certified Phlebotomy Technician I who holds a current, valid certificate from the department or who meets certification requirements as a Certified Phlebotomy Technician I pursuant to Section 1034(a)(4)(A)-(D) and who has at least 1040 hours on-the-job experience in phlebotomy in the previous 5 years as certified in writing by the director(s) of the laboratory(ies) employing the person; and (B) Have completed a minimum of 20 arterial punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations and performed under the general overall responsibility of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, respiratory care practitioner or a licensed clinical laboratory scientist, who will certify in writing that this person has completed this practical instruction; and (C) Apply to the department for certification as a Certified Phlebotomy Technician II pursuant to Section 1031.4(c). (b) Performance of phlebotomy by a person certified by the department shall be limited as follows: (1) A Limited Phlebotomy Technician shall perform skin punctures only when he or she: (A) Maintains a current, valid certification with the department as a Limited Phlebotomy Technician; and (B) Performs skin punctures under the supervision of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a designee. A designee shall be licensed or certified under Chapter 3 and shall be accountable to the laboratory director for skin punctures and other duties related to blood collection performed by the Limited Phlebotomy Technician. The supervisor shall review the work of the technician at least once a month and be accessible to the location where the technician is working to provide on-site, telephone, or electronic consultation when blood is being collected; and (C) Is shown to be competent to perform skin punctures after employment without direct and constant supervision before being allowed to perform skin puncture on patients. Documentation of competency shall be done at least annually; and (D) Has completed at least three hours per year, or six hours every two years, of continuing education in phlebotomy related courses from a provider of continuing education approved pursuant to Article 2.5; and (E) Has posted at the work location in the laboratory employing the person, a current, valid state certificate as a Limited Phlebotomy Technician. When performing skin punctures away from the posted location, the Limited Phlebotomy Technician shall carry a current, valid identification card issued by the department attesting the person's name, certificate type and effective dates of certification as a Limited Phlebotomy Technician. (2) A Certified Phlebotomy Technician I shall perform skin punctures and venipunctures only when he or she: (A) Maintains a current, valid certification with the department as a Certified Phlebotomy Technician I; and (B) Performs skin punctures and venipunctures under the supervision of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a designee. A designee shall be a person licensed or certified under Chapter 3 and shall be accountable to the laboratory director for skin punctures, venipunctures and other duties related to blood collection performed by the Certified Phlebotomy Technician I. The supervisor shall review the work of the technician at least once a month and be accessible to the location where the technician is working to provide on-site, telephone, or electronic consultation as needed; and (C) Is shown to be competent to perform skin puncture and venipuncture after employment without direct and constant supervision before being allowed to perform skin punctures or venipunctures on patients. Documentation of competency shall be done at least annually; and (D) Has completed at least three hours per year, or six hours every two years, of continuing education in phlebotomy related courses from a provider of continuing education approved pursuant to Article 2.5; and (E) Has posted at the work location of the laboratory employing the person, a current, valid state certificate as a Certified Phlebotomy Technician I. When performing skin punctures or venipunctures away from the posted location, the Certified Phlebotomy Technician I shall carry a current, valid identification card issued by the department attesting the person's name, certificate type and effective dates of certification as a Certified Phlebotomy Technician I. (3) A Certified Phlebotomy Technician II shall perform skin punctures and venipunctures only under conditions pursuant to Section 1034(b)(2), and shall be limited to performing arterial punctures only when a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a respiratory care practitioner is present at the location during performance of an arterial puncture, and when he or she: (A) Maintains a current, valid certification with the department as a Certified Phlebotomy Technician II; and (B) Is shown to be competent to perform arterial punctures after employment by direct, personal observation and documentation of his or her expertise in arterial punctures by a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, licensed clinical laboratory scientist or a respiratory care practitioner. Documentation of competency shall be done at least annually; and (C) Has completed at least three hours per year, or six hours every two years, of continuing education in phlebotomy related courses from a provider of continuing education approved pursuant to Article 2.5; and (D) Has posted at the work location in the laboratory employing the person, a current, valid state certificate as a Certified Phlebotomy Technician II. When performing arterial punctures, skin punctures, or venipunctures away from the posted location, the Certified Phlebotomy Technician II shall carry a current, valid identification card issued by the department attesting the person's name, certificate type and effective dates of certification as a Certified Phlebotomy Technician II. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1220, 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code. s 1034.1. Unlicensed Personnel, Laboratory Aides. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. s 1034.2. Unlicensed Personnel, Cytotechnologist. Note: Authority cited: Section 1224, Business and Professions Code; Section 208, Health and Safety Code. Reference: Section 1270, Business and Professions Code; Section 1002, Health and Safety Code. s 1035. Training Schools. (a) Any person operating a school or conducting any course for the purpose of training or preparing individuals for a license under the provisions of Chapter 3, Division 2 of the Business and Professions Code shall submit, on forms provided by the department and subject to periodic renewal, such information as may be required by the department to satisfactorily evaluate the personnel, equipment, quality of instruction, and scope of activities of said schools. (b) Persons providing instruction in general or specialized technic shall provide training which when successfully completed will fully qualify individuals to meet the minimum requirements for licensure under the provisions of Article 4, Chapter 3, Division 2 of the Business and Professions Code. (c) A training school shall accept a person licensed for training in clinical laboratory procedures only if there are on active duty in the laboratory a minimum of two full-time actively employed persons who possess any of the following licenses: clinical laboratory technologist, clinical laboratory bioanalyst, physician and surgeon, or appropriate laboratory specialty. (d) The ratio of licensed clinical laboratory personnel to trainees shall be no less than 2:1. (e) The following shall be minimum requirements for approval of laboratories to employ clinical laboratory technologist trainees as provided for in Article 2 of Chapter 3, Division 2 of the Business and Professions Code: (1) There shall be adequate space and necessary equipment as defined by the department to carry out the procedures of the laboratory and to provide training for the clinical laboratory technologist trainees. (2) The workload of the laboratory training clinical laboratory technologist trainees shall meet minimum standards set by the department and shall include at least the following: routine chemical determinations commonly required on blood, spinal fluid, and other body fluids; morphological, cultural, chemical and immunological tests for microbial pathogens; tests for helminths and protozoa; examinations for normal and abnormal blood cells; sedimentation rates, bleeding and coagulation time determinations and other commonly employed tests in hematology; precipitation, flocculation, agglutination or complement fixation tests; blood typing, Rh factor determinations and pretransfusion procedures; commonly employed serological tests; routine and microscopic urinalyses and such other technics as may be required to properly instruct clinical laboratory technologist trainees in current clinical laboratory procedures. (3) The amount of practical training required by each clinical laboratory technologist trainee in order to fulfill the minimum requirements for admission to the licensing examinations shall be in accordance with the provisions of Article 4, Chapter 3, Division 2 of the Business and Professions Code. When one year of practical training in all subjects is necessary, the minimum time devoted to each shall be as follows: Biochemistry................. 12 Weeks Hematology................... 8 Weeks Pretransfusion Procedures.... 4 Weeks Urinalysis................... 4 Weeks Bacteriology................. 9 Weeks Serology..................... 4 Weeks Parasitology................. 3 Weeks Miscellaneous and review..... 8 Weeks (4) When less than one or more than one year of practical training is required toward admission to the clinical laboratory technologists' examination, the above time devoted to the various subjects shall be decreased or increased proportionately after the laboratory director has secured approval from the department for the modification. (5) However, when one or more years of practical training in any one basic science or specialty is necessary, the laboratory director shall modify this schedule, subject to prior approval by the department, so that the area of concentration is in one or more subjects. (6) Unless a trainee is a college graduate, he must receive during the course of his training program a minimum of 40 clock hours of recitation or instruction in the subjects covered in clinical laboratory work other than that received as practical training in the laboratory. Any laboratory school approved for specialist or limited technologist training must provide the department with adequately documented workload and program information and must comply with the minimum requirements heretofore stated in that special field of training. (7) The requirements for the members of the teaching staff must be those considered minimum for licensure, and in addition, persons with an advanced degree in one or more of the fields covered in the curriculum may be included on the teaching staff. (8) The director of any school shall supply sufficient information to the department to satisfy the department that adequate specimen material will be made available for training purposes. (9) There shall be available to persons receiving training a technical library adequate in the number of copies of each text book. (10) The names and addresses of persons receiving training are to be reported to the department at the time of entrance to course and again at completion of course. (11) The department may require such other information as may be necessary to satisfactorily evaluate the application for approval including periodic on-site reviews. (12) Approval for training granted by the department pursuant to requirements of this section may be denied or withdrawn if the school is unable to meet or maintain these requirements. (f) Colleges or universities accredited by the Western College Association or the Northwest Association of Secondary and Higher Schools or an essentially equivalent accrediting agency, as determined by the department, conducting courses for the purpose of training or preparing persons for a license under the provisions of Chapter 3, Division 2 of the Business and Professions Code, shall be considered approved by the department. Provided, however, that when such training is carried out in cooperation with other laboratories than those of said institutions, specific approval shall be obtained. s 1035.1. Phlebotomy Training Program Requirements. (a) In order to be eligible for approval by the department to provide didactic and/or practical phlebotomy instruction leading to certification of phlebotomists, a phlebotomy training program shall meet the requirements of this section and be offered by either a: (1) National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) approved program for training phlebotomists; or (2) Accredited college or university; or (3) Private, post-secondary program or occupational program registered or approved by the Bureau for Private Postsecondary and Vocational Education; or (4) California Adult Education or Regional Occupational Program (ROP); or (5) United States of America military medical laboratory specialist program; or (6) California licensed clinical laboratory. (b) A phlebotomy training program shall be directed by a licensed physician and surgeon, licensed physician assistant, registered nurse, or person licensed under Chapter 3, who shall be responsible for: (1) Overall operation and administration of the phlebotomy training program; and (2) Ensuring the quality of the technical, scientific and clinical instruction; and (3) Ensuring that the person(s) providing instruction meets the qualifications of this section; and (4) Ensuring that the person(s) providing instruction is competent and that his or her work performance is periodically evaluated, monitored and documented. (c) The person(s) providing instruction shall be a: (1) Licensed physician and surgeon; or (2) Licensed physician assistant; or (3) Registered nurse; or (4) Person licensed under Chapter 3; or (5) Respiratory care practitioner with a minimum of 2 years experience in the previous 5 years; or (6) Certified phlebotomy technician with a minimum of 3 years of experience in the previous 5 years or a phlebotomist with 3 years of experience in the previous 5 years and employed as a phlebotomy instructor, who shall meet certification requirements pursuant to Section 1034(a)(4) on or before December 31, 2003. (d) Person(s) specified in Subsection (c)(1) through (5) shall pass a written examination in phlebotomy, administered by a certifying organization approved by the department pursuant to Section 1031.7 either: (1) Prior to employment by a phlebotomy training program approved by the department pursuant to this section; or (2) No later than December 31, 2003, if employed as a phlebotomy instructor on or before April 9, 2003. (e) An approved phlebotomy training program shall provide the following didactic instruction to its students: (1) A basic phlebotomy curriculum consisting of a minimum of 20 hours lecture and testing for knowledge of: (A) Basic infection control, universal precautions and safety; and (B) Basic anatomy and physiology of body systems with emphasis on the circulatory system, the appropriate medical terminology; and (C) Proper identification of patient and specimens, the importance of accuracy in overall patient care; and (D) Proper selection and preparation of skin puncture site, including selection of antiseptic; and (E) Blood collection equipment, types of tubes and additives, proper order of draw when additives are required, special precautions; and (F) Post-puncture care; and (G) Appropriate disposal of sharps, needles and waste. (2) An advanced phlebotomy curriculum consisting of a minimum of 20 hours of lecture and testing for knowledge of: (A) Advanced infectious disease control and biohazards; and (B) Anti-coagulation theory; and (C) Knowledge of pre-analytical sources of error in specimen collection, transport, processing and storage; and (D) Anatomical site selection and patient preparation; and (E) Risk factors and appropriate responses to complications which may arise from phlebotomy; and (F) Recognition of, and corrective actions to take, with problems in test requisitions, specimen transport and processing; and (G) Applications of basic concepts of communication, interpersonal relations, stress management, professional behavior, ethics and legal implications of phlebotomy; and (H) Quality assurance in phlebotomy necessary to provide accurate and reliable laboratory test results; and (I) Legal issues related to blood collection. (f) An approved phlebotomy training program shall provide a clinical setting for a minimum of 40 hours of practical instruction in phlebotomy. This setting shall provide access to patients whose blood is being tested by a clinical laboratory. In order for a program to be eligible for approval by the department, it shall provide documentation of a training curriculum that includes: (1) Selection of blood collection equipment appropriate to test requisitions; and (2) Preparation of the patient and infection control; and (3) Skin punctures for testing purposes from patients of varying ages, including pediatric and geriatric, and of varying health and obesity status; and (4) Venipunctures from patients of varying ages, health and obesity status; and (5) Post-puncture care; and (6) Processing of blood containers after collection, including centrifugation; and (7) Proper disposal of needles, sharps and medical waste; and (8) Observation of arterial punctures; and (9) A practical examination showing evidence of successful completion of Subsections (f)(1) through (7). (g) A phlebotomy training program shall be responsible for assuring that a student completes a minimum of 10 skin punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements and 50 venipunctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations during or after his or her practical instruction. (h) A phlebotomy training program shall provide a certificate of completion to its students upon satisfactory completion of the program. The program shall maintain a copy of this certificate for five years. This certificate shall be signed by the director of the program and shall include: (1) Name and address of the training program; and (2) Name of the student; and (3) Statement of satisfactory completion of the program; and (4) Dates that training began and ended. (i) A phlebotomy training program seeking approval from the department shall provide documentation to substantiate that its program objectives meet training criteria stated in this section. Verification may include an on-site inspection of the program. (j) A complete application for phlebotomy training program approval shall include the following: (1) Name and address of the training program; and (2) Location(s) of all sites where didactic and practical instruction occur; and (3) Name(s) and license number(s) of the physician and surgeon, physician assistant, registered nurse, or person licensed under Chapter 3 who is directing the program; and (4) Name(s), license number(s) or certificate number(s), experience in phlebotomy, and evidence of satisfactory performance on a phlebotomy certification examination administered by a certifying organization with departmental approval in effect at the time the examination was administered, of every physician and surgeon, physician assistant, registered nurse, person licensed under Chapter 3, respiratory care practitioner, certified phlebotomy technician, or phlebotomist pursuant to Subsection (c)(6) who is supervising or providing instruction; and (5) List of equipment, supplies and educational materials used for instruction; and (6) Curriculum and instructional objectives, including hours spent at each activity. (k) Timeframes for approval of training programs shall be as follows: (1) Submission of an application for approval shall be deemed to occur on the date the complete application is received by the department. (2) Written notification by the department to the applicant shall be considered to occur on the date the documents are postmarked. (3) The department shall notify the applicant within 60 days of submission of an application for training program approval, of one of the following: (A) That the application is complete and acceptable for processing by the department; or (B) That the application is incomplete and not accepted for processing. This notification shall include the specific information or documentation that the applicant shall submit within 30 days in order for the department to consider the application acceptable; or (C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied. (4) The department shall consider an application to have been abandoned by any applicant who fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1035.1(k)(3)(B). (5) The department's time periods for processing an application, from the date the initial application is received to the date the final decision is made regarding approval, are as follows: (A) The median time for processing an application is 90 days. (B) The minimum time for processing is 30 days. (C) The maximum time for processing is 150 days. (l) Approval shall be valid for a two-year period. (m) To apply for renewal, a training program shall file a renewal application at least 60 days prior to the end of the approval period and provide the following: (1) The name and address of the training program; and (2) The name and license number of all directors; and (3) The name, license or certificate number of all instructors; and (4) The name(s) and location(s) of all didactic and practical instruction; and (5) The curriculum and instructional objectives, including hours spent at each activity; and (6) The schedule of didactic and practical instruction for the next 24 months; and (7) The listing of students who completed its program and the total number of students who enrolled in its program in the previous approval period; and (8) The signature of the director(s) and date of the application for renewal. (n) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department. (o) The training program shall notify the department in writing of any change(s) in the information and material required by Subsections (a) through (h) within 30 days after the change(s) has occurred. Note: Authority cited: Sections 1224 and 1320, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1220, 1222, 1222.5, 1242, 1242.5, 1246, 1269 and 1300, Business and Professions Code; and Section 120580, Health and Safety Code. s 1035.3. Medical Laboratory Technician Training Program Standards. (a) In order to be eligible for approval by the department, a medical laboratory technician training program shall be offered by either a: (1) California licensed clinical laboratory; or (2) Accredited college or university in the United States of America; or (3) United States of America military medical laboratory specialist program of at least 26 weeks duration; or (4) Laboratory owned and operated by the United States of America. (b) The program director of a medical laboratory technician training program shall be a physician and surgeon licensed under Chapter 5, or a doctoral scientist, clinical laboratory bioanalyst, clinical laboratory scientist or clinical laboratory specialist licensed under Chapter 3. The program director shall be responsible for the content, quality and conduct of the training program and shall: (1) Employ instructors who are physicians and surgeons licensed under chapter 5; doctoral scientists, clinical laboratory bioanalysts, clinical laboratory scientists, or clinical laboratory specialists licensed under chapter 3; medical laboratory technicians with five years practical experience licensed under Chapter 3; or public health microbiologists certified pursuant to Health and Safety Code Section 101160. (2) Assure that training includes at least 26 weeks, consisting of at least 1040 hours, of instruction and practical experience in moderate complexity testing in chemistry, including routine chemistry, urinalysis, endocrinology and toxicology; hematology; microbiology, including bacteriology, mycobacteriology, mycology, parasitology and virology; and immunology, including syphilis serology and general immunology. The training shall include at least 160 hours each in chemistry, hematology, microbiology and immunology. (3) Provide didactic training in: (A) Pre-analytical skills including phlebotomy, specimen processing, reagent preparation, and infection control, as specified in Section 1035.1(e) and (f); and (B) Analytical skills required for performing tests of waived or moderate complexity, including quality control, test calibration, quality assurance, legal requirements for documentation of testing, data storage and retrieval, safety and standard precautions, troubleshooting, preventive maintenance, reagent preparation and storage; and (C) Post-analytical skills such as knowledge of factors that influence test results and the ability to access and verify the validity of patient test results through review of quality control values prior to reporting patient test results; and (D) Test methods commonly used in chemistry, hematology, microbiology and immunology, including clinical significance of test results, how the tests interrelate and how the tests impact diagnosis and treatment, quality assessment of test results, information processing and regulatory compliance in state and federal law. (4) Provide practical training in: (A) Phlebotomy that shall include 40 hours instruction and successful completion of a minimum of 10 skin punctures and 50 venipunctures, as specified in Section 1035.1(f); and (B) Instruction and practical experience in the use of instruments; and (C) Preventive maintenance and problem solving malfunctions of instruments; and (D) Knowledge of instrument and test parameters to assess reasonableness of results; and (E) Validation of moderate complexity test methods and clinical correlation of test results. (c) A medical laboratory technician training program shall provide a certificate of completion to its students upon satisfactory completion of the program. The program shall maintain a copy of this certificate for at least five years. This certificate shall be signed by the director of the program and shall include: (1) Name and address of the training program; and (2) Name of the student; and (3) Statement of satisfactory completion of the program; and (4) Dates that training began and ended. (d) A program approved to train medical laboratory technicians shall maintain records of its students for at least five years and shall make available to the department documentation of the students successfully completing their training. (e) A medical laboratory technician training program seeking approval from the department shall provide documentation to substantiate that its program objectives meet training criteria stated in this section. (f) A medical laboratory technician training program shall be allowed to document program compliance with the requirements of this section for a period dating up to four years prior to their initial application, after the date of implementation of these standards. The program shall document that, during the time preceding initial approval, the training program met the standards pursuant to Section 1035.3(a) and (b). (g) A complete application for a medical laboratory technician training program shall include the following: (1) The name and address of the primary training program, including city, state, county and zip code; telephone number, FAX number and e-mail address; and (2) The location(s) of all sites where training will be conducted, including city, state and zip code; and (3) The name(s) and qualifications of the person(s) directing and instructing in the program including a copy of current licensure for each person. Training programs in the United States of America but outside California shall provide evidence that the director(s) and instructor(s) substantially meet this licensure requirement by documenting inclusion, licensure or certification in a class of personnel similar to those required in Chapter 3 or requiring equivalent standards; and (4) Dates the training program was conducted if prior approval is requested as specified in Section 1035.3(f); and (5) The didactic curriculum listing each class or topic with instructional objectives, the instructor(s) and the amount of time allocated for each class or topic, pursuant to Section 1035.3(b)(3); and (6) Documentation of practical training in pre-analytical, analytical and post-analytical skills, including instructor(s) and hours spent at each activity, list of equipment, supplies and materials used pursuant to Section 1035.3(b)(4); and (7) The signature(s) of the program director(s), telephone number(s) and date of application. (h) A medical laboratory technician training program approval shall be valid for a four-year period. To apply for renewal, the training program shall file an application at least 120 days prior to the end of the approval period providing the following: (1) The name and address of the primary training program, including city, state, county and zip code, telephone number, FAX number and e-mail address; and (2) The name, address, and telephone number(s) of the director(s) and instructor(s), providing documentation of their current licensure; and (3) Any changes in training locations, didactic and practical instruction, course objectives, equipment, supplies and materials, that shall be made to the program from that approved in the previous application; and (4) A listing of all students who completed its program and the total number of students who enrolled in its program during the previous approval period; and (5) The signature(s) of the program director(s) and the date of application for renewal. (i) The training program shall notify the department in writing of any change(s) in the information and materials required by Section 1035.3(b) through (d) within 30 days after the change(s) has occurred. (j) Failure to meet and maintain the requirements of this section shall be good cause for denial or revocation of approval by the department. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5, 1208, 1209, 1222, 1222.5, 1242, 1246, 1260.3, 1269, 1286 and 1300, Business and Professions Code. s 1035.4. Timeframes for Approval of Training Programs. (a) Timeframes for approval of training programs to train clinical laboratory personnel for licensure pursuant to Chapter 3 shall be as follows: (1) Submission of an application for approval shall be deemed to occur on the date the application is received by the department. (2) Written notification by the department to the applicant program shall be considered to occur on the date the documents are postmarked. (3) The department shall notify the applicant within 60 days of submission of an application for training program approval, of one of the following: (A) That the application is complete and acceptable for processing by the department; or (B) That the application is incomplete and not accepted for processing. This notification shall include the specific information or documentation that the applicant shall submit within 30 days in order for the department to consider the application acceptable; or (C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied. (4) The department shall consider an application to have been abandoned by any applicant program which fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1035.4(a)(3)(B). (b) Timeframes for processing applications for renewal of approval to train clinical laboratory personnel for licensure pursuant to Chapter 3 shall be as follows: (1) The training program shall submit a renewal application at least 120 days prior to the end of the approval period. (2) Within 30 days of receipt of a renewal application, the department shall inform the training program in writing that the application is complete and accepted for review, or deficient and what specific information or documentation is required to complete the application. (3) Within 30 days of submitting a completed renewal application, the department shall inform the training program in writing whether its application has been approved or denied. (4) The department may authorize a training program to extend its approval during the time its application is being reviewed when that training program is in good standing and its application was submitted at least 120 days prior to the end of the approval period. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1261.5, 1263, 1264, 1286 and 1302, Business and Professions Code. s 1036. Clinical Consultant. (a) Every clinical laboratory director, under whom moderate or high complexity tests or examinations are performed, shall either perform the duties of a clinical consultant or employ a clinical consultant who can provide consultation about the appropriateness of testing ordered and interpretation of test results, as specified in Section 1209, chapter 3 of the Business and Professions Code. (b) The clinical consultant shall possess a current, valid license issued by the State to direct a clinical laboratory pursuant to chapter 3, Business and Professions Code, or to practice medicine, osteopathy or podiatry pursuant to chapter 5, Business and Professions Code appropriate to the specialties and subspecialties for which he or she is consulting. (c) The clinical consultant shall: (1) Provide clinical consultation to the clients of the laboratory; and (2) Assist in ordering tests appropriate to meet clinical expectations; and (3) Ensure that test results include pertinent information required for interpretation; and (4) Communicate matters about quality of test results reported and interpretation in relation to specific patient conditions. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code. s 1036.1. General Supervisor. (a) Every clinical laboratory director, under whom high complexity tests or examinations are performed, shall either perform the duties of a general supervisor or employ a general supervisor who shall be responsible for day-to-day supervision of laboratory operation and personnel performing and reporting high complexity tests, pursuant to Section 1209, chapter 3 of Business and Professions Code. (b) A general supervisor shall: (1) Possess an active, valid license issued by the State to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties they are supervising; and (2) Have a minimum of two years' experience in high complexity testing in the specialty or specialties they are supervising. (c) The general supervisor shall be accessible to testing personnel at all times testing is performed by providing on-site, telephone or electronic consultation to resolve technical problems. (d) The general supervisor shall be responsible for ensuring that tests and examinations are performed in compliance with chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 standards as published October 1, 1994, regarding clinical laboratories. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code. s 1036.2. Moderate Complexity Laboratory Technical Consultant. (a) Every laboratory director, under whom moderate complexity tests or examinations are performed, shall either perform the duties of a moderate complexity laboratory technical consultant or employ a moderate complexity laboratory technical consultant who is responsible for providing technical and scientific consultation for each of the specialties and subspecialties performed. (b) A moderate complexity laboratory technical consultant of a laboratory performing moderate complexity testing shall: (1) Possess an active, valid license issued by the State pursuant to chapter 3 of the Business and Professions Code to perform high complexity testing, or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties for which he or she is consulting; and (2) Have a minimum of two years' experience in moderate or high complexity testing in the specialty or specialties for which he or she is consulting. (c) A moderate complexity laboratory technical consultant shall be responsible for the technical and scientific oversight of the laboratory as specified in Section 493.1413, Title 42, Code of Federal Regulations, as published October 1, 1994. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code. s 1036.3. Waived Laboratory Supervisor. (a) A laboratory director of a clinical laboratory performing waived tests may delegate or reapportion his or her responsibilities, as allowed by Section 1209 of the Business and Professions Code, by utilizing a waived laboratory supervisor. Except for a waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code and pursuant to subsection (c) and (d), a waived laboratory supervisor shall: (1) Be listed in Section 1206.5 of the Business and Professions Code; and (2) Possess at least a baccalaureate degree from an accredited college or university; and (3) Have at least one year of training or experience in clinical laboratory testing in those tests or examinations that he or she will be supervising; and (4) Document competency in those tests he or she will be supervising to the laboratory director at least semiannually during the first year and annually, or whenever new instrumentation is added, thereafter. (b) Except for a waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code, a waived laboratory supervisor shall be responsible for: (1) Selecting, in consultation with the laboratory director, the test methodology appropriate for clinical use of test results; and (2) Establishing a quality control program appropriate for the tests performed, which follows the test manufacturer's parameters for acceptable levels of analytical performance and ensures that these levels are maintained throughout the entire testing process from initial receipt of the specimen through sample analysis and test result reporting; and (3) Resolving technical problems and ensuring remedial actions are taken and documented whenever test systems deviate from the manufacturer's established performance specifications; and (4) Ensuring patient test results are not reported until all corrective actions have been taken and the test system is performing properly; and (5) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for waived testing; and (6) Evaluating and documenting that the staff maintain their competency to perform test procedures and report tests promptly, accurately and proficiently by: (A) Directly observing routine test performance, including patient preparations (if applicable), specimen handling, processing and testing; and (B) Monitoring the recording and reporting of test results; and (C) Reviewing quality control records and preventive maintenance records; and (D) Directly observing performance of instrument maintenance and function checks; and (E) Assessing problem solving skills; and (F) Evaluating and documenting the performance of individuals responsible for waived testing at least semiannually during the first year the individual tests patient specimens. Thereafter evaluations shall be performed at least annually unless test methodology or instrumentation changes (in which case and prior to reporting patient test results, the individual's performance shall be re-evaluated to include the use of the new test methodology or test instrumentation). (c) A waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code shall: (1) Hold a current, active license as an Emergency Medical Technician-Paramedic pursuant to Health and Safety Code Section 1797.194, as a registered nurse pursuant to Chapter 6 (commencing with Section 2700) or as a person under Chapter 3 (commencing with Section 1200) authorized to engage in clinical laboratory practice or to direct a clinical laboratory; and (2) Have at least one year training or experience in blood glucose testing in the method or procedure that he or she will be supervising. (d) The waived laboratory supervisor of a laboratory performing blood glucose testing as specified in subsection (c) shall be responsible for: (1) Documenting that each individual performing blood glucose is competent to perform the test before he or she starts testing and whenever new methodologies or technologies are added; and (2) Ensuring that manufacturer's instructions for test performance, equipment maintenance and quality control are followed; and (3) Resolving technical problems and ensuring remedial actions are taken and documented whenever test systems deviate from the manufacturer's established performance specifications. (e) A waived laboratory technical supervisor shall be accessible to the laboratory testing personnel to provide onsite, telephone or electronic consultation. The laboratory director of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code may designate a licensed physician and surgeon or an authorized registered nurse at the hospital serving as the base hospital to provide such consultation. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code. s 1036.4. Technical Supervisor. (a) Every laboratory director, under whom high complexity tests or examinations are performed, shall either perform the duties of a technical supervisor or employ a technical supervisor who is responsible for the technical and scientific oversight of the laboratory. (b) A technical supervisor of a laboratory performing high complexity testing shall: (1) Possess an active, valid, license issued by the state to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry, pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties for which they are consulting; and (2) Meet the experience requirements in Section 493.1449 of Title 42 of the Code of Federal Regulations, as published October 1, 1994. (c) While not required to be on site at all times testing is performed, a technical supervisor shall be available to laboratory testing personnel at all times to provide either on-site, telephone or electronic consultation. (d) A technical supervisor shall be responsible for all the activities listed in Section 493.1451 of Title 42 of the Code of Federal Regulations, as published October 1, 1994. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code. s 1038. Definitions. (a) The definitions set forth in subsections b through j inclusive shall govern the interpretation of this article. (b) "Contact Hour" means the actual time a licensee participates in continuing education offered by an approved provider, utilizing the following conversion standards: 50-60 minutes = 1 contact hour 0.1 continuing education unit (CEU) = 1 contact hour 1 quarter unit = 10 contact hours 1 semester unit = 15 contact hours (c) "Accredited Academic Institution" means an academic institution accredited by the Western Association of Schools and Colleges or an accrediting organization recognized by the Council of Post Secondary Education. (d) "Accrediting Agency" means an organization approved by the Department pursuant to Section 1038.2 which evaluates and grants approval to providers of continuing education who comply with the standards of that agency, and who are other than those identified in (c) above. (e) "Approved Provider" means an accredited academic institution or any person or entity offering continuing education who has been approved by an accrediting agency. (f) "Licensee" means those persons other than clinical laboratory technologist trainees licensed pursuant to Chapter 3 (commencing with section 1200) of Division 2 of the Business and Professions Code. (g) "Quarter Unit" and "Semester Unit" means the hours of instruction offered by an accredited academic institution which are credited by that institution as a quarter unit and semester unit respectively. (h) "Active Status" means a current license in good standing which authorizes the licensee to perform the functions described in this chapter. (i) "Inactive Status" means a license which is not in good standing because the holder has not completed the continuing education requirements of this article or has voluntarily requested that the license be made inactive. (j) "Continuing Education Program" means a presentation given by an approved provider at a scheduled time or times which conforms to the requirements of section 1038.3. Note: Authority cited: Sections1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code. s 1038.1. Continuing Education Requirements. (a) All persons licensed under Division 2, Chapter 3 of the Business and Professions Code, commencing with Section 1200, whose license is in active status shall complete 12 contact hours of continuing education each calendar year. All persons licensed with more than one active license type pursuant to Division 2, Chapter 3 of the Business and Professions Code shall be able to renew all license types after completion of a total of 12 contact hours of continuing education each calendar year. (b) At the time of renewal, each licensee shall provide the Department with the date, name and number of contact hours received for each continuing education program successfully completed by the licensee in the previous calendar year. (c) The licensee shall retain continuing education documents received from approved providers under Section 1038.4 for a minimum of four years. (d) A random sample of licensees shall be audited by the Department to determine compliance with the continuing education requirement. Those licensees selected for audit shall submit to the Department, within 30 calendar days of notification of selection, a copy of each document provided the licensee under section 1038.4(c) since the date of last license renewal. (e) Any licensee who is found to have not successfully completed the continuing education requirement of this article will be placed in inactive status. The licensee shall have the right to appeal such findings to the Department. An appeal shall be conducted in compliance with chapter 5 (commencing with section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code. s 1038.2. Accrediting Agencies. (a) Any organization seeking approval as an accrediting agency shall submit an application to the Department which shall include documentation of the following: (1) The organization's name, address, and owner(s); (2) The organization's structure, function, and philosophy for monitoring the content, quality, and faculty of approved programs; and, (3) The person designated by the organization to be responsible for overseeing the administration and coordination of all continuing education providers approved by the organization. (b) The Department's review of an accrediting agency shall include an evaluation of the following: (1) Whether the organization's philosophy shows an identifiable commitment to continuing education; (2) Whether the organization's mechanism for monitoring the content, faculty, education methods, quality, and facilities of approved providers meets the criteria of section 1038.3; and, (3) Effective mechanisms for responding to complaints about approved providers and the ability to take effective action to insure that approved providers comply with sections 1038.3 and 1038.4. (c) The Department shall approve an organization as an accrediting agency and issue an approval upon satisfactory review under subsections (a) and (b). Such approval may be subject to special terms as specified by the Department. (d) Within 30 calendar days of receipt of an application by an organization for approval as an accrediting agency, the Department shall inform the organization in writing that the application is either complete and accepted for review or that it is deficient and what specific information or documentation is required to complete the application. (e) Within 30 calendar days from the date of filing of a completed application, the Department shall inform the applicant organization in writing whether the organization has been approved as an accrediting agency. (f) The Department's time periods for processing an application for approval as an accrediting agency, from the receipt of the initial application to the final decision regarding the approval, are as follows: (1) The median time for processing is 60 calendar days. (2) The minimum time for processing is 45 calendar days. (3) The maximum time for processing is 90 calendar days. (g) An accrediting agency shall maintain for five years and shall make available to the Department, the name of each approved provider, the title, date, and number of contact hours awarded for each program offered by its approved providers, and a list of all participants in each program offered. (h) An accrediting agency shall be subject to review by the Department to determine adherence to requirements of this article. Failure of an accrediting agency to meet the requirements of this article or its terms of approval is good cause for revocation of approval by the Department. Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code. s 1038.3. Approval of Providers. (a) An accrediting agency shall approve only providers who offer continuing education programs that meet all of the following criteria: (1) Use instructors who are competent in subject matter by education, training or experience; (2) Are a minimum of 50 minutes in duration excluding evaluation by participants of the continuing education program; (3) Are relevant to the scope of practice of clinical laboratory science and may include education, supervision, and management; (4) Have clearly stated, measurable, education objectives; and, (5) Use teaching methods which are consistent with the objectives of the continuing education program. Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code. s 1038.4. Approved Providers. (a) No person or entity shall represent itself as an approved provider unless approved by an accrediting agency or unless it is an accredited academic institution. (b) Approved providers shall issue certificates to participants which include: (A) The participant's name; (B) Contact hours; (C) Date of continuing education provided; (D) Name and address of both program provider and accrediting agency; and, (E) Signature of instructor and/or provider or provider designee. (c) Accredited academic institutions shall provide certificates to every participant upon completion of a continuing education program which includes all the information in subsection (b), except the approved provider will not be required to issue a certificate when the continuing education program is a regularly scheduled class and documented on a student transcript. (d) An approved provider shall maintain an official record verifying all participants' attendance at continuing education programs for at least four years after the completion date. The provider shall include the participant on the official record of attendance only if the participant's signature was obtained at the time of attendance at the program. The official record of attendance shall contain the name of the participant and shall identify the time, date, location, subject matter, and length of the continuing education program and shall be provided to the Department upon request at no cost to the Department. (e) If two or more approved providers jointly provide a continuing education program, the providers shall designate the provider responsible for keeping records and issuing certificates to participants. (f) An approved provider shall evaluate the effectiveness of continuing education programs to determine whether the program objectives required under section 1038.3 subsection (a)(5) were met. This evaluation shall include a written evaluation by the participants, or pre- and post-examination. (g) An approved provider shall allow, at no cost, in-person observation of continuing education programs by employees of the Department of Health Services for purposes of monitoring compliance with sections 1038.3 and 1038.4. Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code. s 1038.5. Waiver of Requirement. (a) At the time of making application for renewal of a license issued pursuant to Division 2, Chapter 3 of the Business and Professions Code (BPC), a licensee may request a waiver of all or part of the continuing education requirement. To be eligible for a waiver, a license holder shall verify in writing that he or she: (1) Was residing in another country for at least half the license period since the license was issued or, if the license was previously renewed, since it was last renewed, and that this reasonably prevented completion of the continuing education requirements; or (2) Was absent from California for at least half the license period since the license was issued or, if previously renewed, since it was last renewed, because of military service, and that this reasonably prevented completion of the continuing education requirements; or (3) Was prevented from completing the continuing education requirements for reasons of ill health or other good cause, including, but not limited, to: (A) Total physical and/or mental disability of the licensee for at least half of the period since the license was issued or, if previously renewed, since it was last renewed; or (B) Total physical and/or mental disability of an immediate family member for at least half of the period since the license was issued or, if previously renewed, since it was last renewed, where the licensee has total responsibility for the care of that family member. (4) Verification of a disability under paragraph (3) shall include a corroborating statement by a licensed physician. Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code. s 1038.6. Inactive Status. A licensee whose license issued pursuant to Division 2, Chapter 3 of the Business and Professions Code is in inactive status shall document 12 hours of continuing education for the year prior to reinstatement or pass the examination for licensure prior to reinstatement to active status. Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code. s 1038.7. Fees. (a) A fee of $250.00 shall accompany an application for approval or renewal as an accrediting agency. (b) At the time of initial application or renewal of a clinical laboratory personnel license, an additional fee of $8.00 shall be paid by each licensee to support the costs of administering and enforcing the continuing education requirements of this article. Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code. s 1039.1. Recognition of CLIA Certification for Limited Purpose and Period. (a) Except for a certificate of accreditation issued by HHS, a CLIA certificate issued to a clinical laboratory that on December 31, 1995 was not required to obtain a state license pursuant to Section 1241 of Chapter 3, shall be considered to be a state license or registration issued pursuant to Chapter 3 until such time as CLIA exempt status is obtained, provided that the CLIA certificate is for the type and complexity of clinical laboratory tests or examinations performed and that it remains in effect, unsuspended and unrevoked during the entire period covering January 1, 1996 to when CLIA exempt status is granted by HHS. (b) A certificate of accreditation issued by HHS to a clinical laboratory that on December 31, 1995 was not required to obtain a state license pursuant to Section 1241 of Chapter 3, shall be considered a state license or registration issued pursuant to Chapter 3 until such time as the accreditation body, upon whose accreditation the certificate of accreditation was issued by HHS, fails to be approved by the department as having accreditation standards that are equal to, or more stringent than, state requirements for licensure; and, provided that: (1) The certificate of accreditation issued by HHS is for the type and complexity of clinical laboratory tests or examinations performed and that it remains in effect, unsuspended and unrevoked; and (2) After exempt status is obtained, the accredited laboratory pays the department the $100 annual certificate of accreditation renewal fee. (c) A certificate of waiver issued by HHS, to a clinical laboratory that on December 31, 1995 was required to obtain a state license, and that performs only waived tests, physician performed microscopy, or both, shall be considered to be a state registration issued pursuant to Chapter 3 until such time as CLIA exempt status is obtained, provided that the certificate of waiver remains in effect, unsuspended and unrevoked during the entire period covering January 1, 1996 to when CLIA exempt status is granted by HHS. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1220, 1241, 1265, 1281 and 1288.5, Business and Professions Code. s 1039.2. Clinical Laboratory Personnel Requirements. (a) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations in California shall meet the requirements for performing, supervising, consulting on, or directing laboratory tests or examinations as set forth in Chapter 3 for the type and complexity of tests performed and irrespective of whether the clinical laboratory is operated under a CLIA certificate or under a state license or registration. (b) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations outside California on biological specimens originating in California, and irrespective of whether the clinical laboratory where the tests or examinations are performed is operated under a CLIA certificate or under a state license or registration, shall meet all personnel requirements set forth in Chapter 3 for the type and complexity of testing performed, or shall provide evidence to the department that they substantially meet those requirements by documenting inclusion, licensure or certification in a class of personnel similar to those required in Chapter 3 or requiring equivalent standards. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1241, 1244, 1265, 1281 and 1288.5, Business and Professions Code. s 1039.3. State Licensure or Approval Required During CLIA Exemption. All clinical laboratories except those identified in subdivision (b) of Section 1241, or in Section 1244 of the Business and Professions Code, shall have in effect a state license or state registration, and all public health laboratories shall be approved public health laboratories during any period for which HHS grants CLIA exempt status for clinical laboratories or public health laboratories licensed, registered or approved by the department. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1241, 1244, 1265, 1281 and 1288.5, Business and Professions Code. s 1040. Forfeited Licenses. (a) No license which has been forfeited for failure to pay the required fee shall be reinstated until a written request for reinstatement and all unpaid fees have been received by the department. (b) If the renewal fee is not paid for five or more years, an examination will be required in addition to the requirements of subsection (a) above before the license may be reinstated, except as otherwise provided in Division 2, Chapter 3, Section 1301 of the Business and Professions Code. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 1303, Business and Professions Code. s 1041. Fee Credits. Each clinical laboratory that pays a fee subject to reduction under subdivision (u) of Section 1300 of the Business and Professions Code shall have any reduction credited against the clinical laboratory's future license, registration or other fees payable under Chapter 3. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1300, Business and Professions Code. s 1042. Substantial Relationship Criteria. Four purposes of denial, suspension or revocation of a license, certificate or permit pursuant to Division 1.5 (commencing with Section 475) of the Business and Professions Code, a crime or act shall be considered to be substantially related to the qualifications, functions, or duties of a person who is an applicant or holder of a license, certificate or permit under Chapter 3, Division 2, of the Business and Professions Code if to a substantial degree it evidences present unfitness of a person holding a license, certificate or permit to perform the functions authorized by such license, certificate or permit in a manner consistent with the public health, safety or welfare. Such crimes or acts shall include but not be limited to the following: (a) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provision of Chapter 3, Division 2 of the Business and Professions Code. (b) Acts of dishonesty, fraud or deceit with intent to substantially benefit himself or another, or substantially injure another. (c) Acts of gross negligence in the performance of functions authorized by the license, certificate or permit under Chapter 3, Division 2, of the Business and Professions Code. A license, certificate or permit shall not be denied, suspended or revoked because of a lack of good moral character or any similar ground relating to a person's character, reputation, personality or habits. Note: Authority cited: sections 208, 3901, 15020 and 25800-25870, Health and Safety Code; section 1224, Business and Professions Code. Reference: Sections 3901, 1500-15023 and 25811, Health and Safety Code; Sections 475, 480, 481, 482, and 1242.5, Business and Professions Code. s 1042.1. Criteria for Evaluating Rehabilitation. (a) When considering the denial of a license, permit or certificate under Section 480 of the Business and Professions Code, for which application has been made under Chapter 3, Division 2, of the Business and Professions Code, the Department, in evaluating the rehabilitation of the applicant and his present eligibility for a license, permit or certificate, shall consider the following criteria: (1) The nature and severity of the act(s) or crime(s) under consideration as grounds for denial. (2) Evidence of any act(s) committed subsequent to the act(s) or crime(s) under consideration as grounds for denial which also could be considered as grounds for denial under Section 480 of the Business and Professions Code. (3) The time that has elapsed since commission of the act(s) or crime(s) referred to in subsection (a) (1) or (a) (2). (4) The extent to which the applicant has complied with any terms of parole, probation, restitution or any other sanctions lawfully imposed upon the applicant. (5) Evidence, if any, of rehabilitation submitted by the applicant. (b) When considering the suspension or revocation of a license, permit or certificate issued under Chapter 3, Division 2 of the Business and Professions Code on the grounds of conviction of a crime, the Department, in evaluating the rehabilitation of such person and his present eligibility for a license, permit or certificate shall consider the following criteria: (1) Nature and severity of the act(s) or offense(s). (2) Total criminal record. (3) The time that has elapsed since commission of the act(s) or offense(s). (4) Whether the licensee has complied with any terms of parole, probation, restitution or any other sanctions lawfully imposed against the licensee. (5) If applicable, evidence of expungement proceedings pursuant to Section 1203.4 of the Penal Code. (6) Evidence, if any, of rehabilitation submitted by the licensee. (c) When considering a petition for reinstatement of a license, permit or certificate, the Department shall evaluate evidence of rehabilitation, considering those criteria of rehabilitation listed in subsection (b). Note: Authority cited: Sections 208, 3901, 15020 and 25800-25870, Health and Safety Code: Section 1224, Business and Professions Code. Reference: Sections 3901, 1500-15023 and 25811, Health and Safety Code; Sections 475, 480, 481, 482 and 1242.5, Business and Professions Code. s 1045. Personnel Report. All clinical laboratory directors shall on or before December 15th of each calendar year transmit to the department, on forms provided by the department, the names of all persons performing clinical laboratory procedures including, but not limited to biochemical, bacteriological, parasitological, hematological, or serological procedures. All clinical laboratory directors shall keep the department advised of current changes in employment of such technical personnel giving employment and/or separation dates of personnel. s 1050. Clinical Laboratory Standards. (a) All licensed clinical laboratories shall be conducted, maintained, and operated without injury to the public health and shall maintain records, equipment, and facilities which are adequate and appropriate for the services rendered and demonstrate satisfactory performance in a proficiency program approved by the department. (b) Proficiency Testing. (1) The laboratory must participate in a state approved proficiency testing program and demonstrate satisfactory performance in all of the laboratory specialties that include tests performed in the laboratory. Proficiency shall be tested in the following specialties: microbiology, serology, clinical chemistry, hematology, and immunohematology. (2) The participating laboratory must test applicable materials each time they are distributed by the approved proficiency testing service according to a schedule approved by the department. (3) Those procedures performed by the laboratory for which test materials are provided by the approved proficiency testing service and which have been designated by the department as a requirement for measuring test performance, must be proficiency tested by the participating laboratory each time test materials are received. (4) The participating laboratory must authorize the approved proficiency testing service to report proficiency test results to the department. (5) The participating laboratory must test applicable materials only in the laboratory to which the license and the proficiency testing requirement applies using personnel and equipment used in that facility in providing services. (6) A laboratory may be required to discontinue providing a service in a procedure or category of procedures if: (A) For three consecutive quarters the laboratory fails to report on test materials received for procedures for which the laboratory is required to be proficiency tested, or (B) For three consecutive quarters the laboratory demonstrates unsatisfactory performance in a procedure or category of procedures. A determination of satisfactory performance for a procedure shall be based upon results being within acceptable limits established by the proficiency testing service for that procedure and approved by the department. A determination of satisfactory performance for a category of procedures shall be based upon an average of performance within the category over four consecutive quarters. (7) A laboratory whose services have been disapproved because of unsatisfactory performance may apply to the department for reapproval to provide these services after demonstrating satisfactory performance during the two consecutive quarters or testing periods immediately prior to requesting reapproval. (c) Direction. The person or persons directing a licensed clinical laboratory shall assume the following responsibilities: (1) Determine what laboratory procedures will be performed, the techniques that will be followed, and the equipment and reagents that will be used. (2) Determine the scope and nature of procedures to control the reliability of test performance and personally monitor these control programs. (3) Regularly assess the activities of the laboratory by personal observation, evaluation, and review of reports of laboratory findings. (4) Establish qualification criteria of laboratory personnel. (5) Determine the format of laboratory report forms and decide what information is to be contained on these report forms. (6) Regularly consult with supervisors and other staff members. (7) Confer with those served by the laboratory on matters that relate to test performance and determine the nature and scope of technical and administrative information to be released by the laboratory staff. (8) Be available daily in any laboratory performing cytology and serve as director of no more than three (3) laboratories. (9) Cause a licensed physician or dentist, qualified in cytopathology, to personally examine and report findings on abnormal or questionable gynecologic and all non-gynecologic specimens. (d) Facilities. The laboratory must provide for and assure that: (1) There is adequate space including working surface to conduct and control the performance of all test procedures performed in the laboratory. (2) There is adequate area for safe storage and use of equipment and supplies. (3) All areas are well lighted and properly ventilated. (4) Fume hoods and biological safety cabinets, properly installed and regulated, are used if required for safe performance of tests or for safe preparation of materials. (5) Instructions to be followed in case of fire and other emergencies are posted in a conspicuous place. (e) Equipment and Test Materials. (1) The laboratory must provide for and assure that equipment, instruments, glassware, and reagents are maintained in proper working order by periodic inspection, testing, or calibration in a manner acceptable to the department. (2) All reagents and stains shall be dated at the time of preparation and initialed by the person making the reagents or stains, or the date received and date opened if commercially prepared reagents or stains are used. All reagents and stains shall be labeled to indicate identity, and titer, strength, or concentration. Recommended storage temperature and expiration date, and other pertinent information necessary for quality control must be on the label. (f) Records. (1) Retention of Records: The laboratory must maintain for a period of at least two years documentation of the following: (A) Records of specimens received and tested, including identification of the patient, name of the submitter, dates of receipt and report, type of test performed, and test results. (B) Records of inspection, validation, calibration, repair, and replacement to insure proper maintenance and operation of equipment and proper reactivity of test materials. (C) Manuals, card files, or flow charts for each procedure performed in the laboratory which include: 1. Name of procedure. 2. Source or reference for the test method. 3. Date the procedure was last reviewed or modified by the director or supervisor. 4. Current specific instructions for test performance. 5. The standards and controls required. 6. Instructions for collecting and handling specimens to insure test reliability. (D) Records of quality control procedures in use in the various technical areas of the laboratory, including results on standards and reference materials and action limits when appropriate. (E) Additional requirements for cytology. The laboratory shall retain all cytology slides and cell blocks for a minimum of five (5) years and all cytology reports for a minimum of ten (10) years. (2) Cytology Specimen Documents. The laboratory shall maintain cytology records indicating the daily accession of specimens, each of which is numbered, and an appropriate cross-filing system according to patient's name. (A) Requests shall contain at least the following information: 1. The laboratory accession number when assigned by the laboratory. 2. The name of the person from whom the specimen was taken. 3. The name of the licensed physician or other authorized person or clinical laboratory who submitted the specimen. 4. Minimum information provided shall include: source of specimen (anatomic site), age of patient, previous therapy (endocrine, surgical, radiation, birth control, etc.), gynecologic history on cervical-vaginal specimens, including date and normalcy of patient's last menstrual period, duration of patient's current pregnancy, if any, and patient's menopausal status or essential history on non-gynecologic specimen. 5. The date the specimen was collected. (B) Reports shall contain at least the following information: 1. The dates the specimen was collected, received in the laboratory and reported by the laboratory; and the accession number. 2. The result of the laboratory examination. (3) Cytology Laboratory Records. (A) The laboratory director shall be responsible for the final laboratory report and shall sign all abnormal and all non-gynecological reports. Each report, or a laboratory copy, shall be signed or initialed by the cytopathologist and/or cytotechnologist who examined the preparation and evaluated the final report. The names of all persons who examined the specimen and their evaluation, if inconsistent with the final report, shall be indicated on the laboratory work sheet or report copy. (B) Duplicate copies of laboratory reports are filed in a manner which permits ready identification and accessibility. (C) Laboratories shall utilize reporting systems that are as explicit as is cytologically feasible and must include acceptable morphologic terminology. (D) If a specimen is judged by the laboratory director or cytotechnologist to be suboptimal, an accompanying statement shall indicate the reason, e.g., samples of sparse cellularity, poor preservation, or exhibiting other factors interfering with the laboratory evaluation, such as, excessive blood, inflammatory cells, etc. (g) Quality Control. (1) The laboratory must conduct, maintain, and operate programs for controlling the quality of test performance in a manner acceptable to the department. (2) Additional Cytology. (A) Specimen Identification. All smears and other specimens shall be labelled for patient identification and appropriately prepared by the submitter. (B) Specimen Preparation. 1. The laboratory shall use the Papanicolaou staining technique or its equivalent as determined by the laboratory director. 2. Staining quality of cytologic specimens shall be checked at least once daily, with suboptimal results corrected immediately. 3. Gynecologic specimens shall be processed totally separately from non-gynecologic specimens. (C) Microscopy. 1. Each specimen shall be evaluated to determine whether the material is satisfactory and consistent with the patient source. For satisfactory specimens, a cytologic evaluation shall be rendered according to the reporting system, as outlined in Section 1050(f)(3)(C). 2. The laboratory shall have a sufficient number of certified cytotechnologists to handle, under general supervision, the volume and diversity of tests performed requiring the exercise of independent judgment. No cytotechnologist shall be required to examine more than 75 one-slide gynecologic cases or 50 two-slide gynecologic cases per day; not including aspiration cytology specimens, cell block specimens, and other not normally examined by a cytotechnologist. Work load ratios for cytotechnologists who also prepare and stain slides shall be based on time spent in examining cytologic preparations. 3. The director or a supervising cytotechnologist shall examine (to verify proper staining and correct interpretation) at least ten (10) percent of all gynecologic smears previously examined and classified as not abnormal or questionable, including smears initially examined by a supervising cytotechnologist. (3) Clinical Correlation. The laboratory shall maintain records for a minimum of 10 years of histologic or clinical confirmation of cytologic findings on abnormal cases and false negative and false positive results for each category of specimens, when such results are made available to them. (h) Clinical Laboratory Test Results. Clinical laboratory test results shall not be reported from the laboratory until these results have been critically reviewed and verified for accuracy, reliability, and validity by a licensed physician and surgeon or a person, other than a trainee, duly licensed under Chapter 3, Division 2, Business and Professions Code (commencing with Section 1200). Note: Authority cited: Sections 1224 and 1245, Business and Professions Code. Reference: Sections 1220, 1224 and 1245, Business and Professions Code. s 1051. Proficiency Testing Services. A service may be approved by the department for proficiency testing laboratories providing the service: (a) Makes available to each participating laboratory (1) Materials not less than four times during each calendar year for testing those procedures which have been designated by the department for evaluation, (2) Acceptable forms for reporting results of proficiency testing, (3) An evaluation of test results reported by the participating laboratory showing acceptable results based on a reference system approved by the department, and (4) A summary of results reported by all participating laboratories prepared at least annually. (b) Provides the department with an adequate description of acceptable procedures for (1) The preparation and distribution of test materials, (2) The determination of limits of acceptable test results, and (3) The reporting of results of performance to the laboratories subscribing to the service. (c) Establishes and maintains an adequate reference system for each procedure evaluated. The names and addresses of all laboratories used as reference or referee laboratories by the service must be provided to and approved by the department. (d) Maintains records of proficiency testing including reports for participating laboratories for a period of not less than five years, such records being available to the department for reference upon request. These records must include: (1) The names and addresses of laboratories subscribing to the service, (2) The test procedures evaluated, (3) The results of performance reported by each laboratory, and (4) The results or range of results which were considered acceptable performance by the service. (e) Makes application for approval on forms provided by the department. s 1052. Satisfactory Performance in Proficiency Testing. The standards for satisfactory performance for laboratories operating in accordance with Subsections (b) and (g), Sections 1241, Division 2, Chapter 3, Business and Professions Code shall be those outlined in Section 1050(b) of this Title. Note: Authority cited: Sections 1224 and 1241.1, Business and Professions Code. s 1053. Definitions. Note: Authority cited: Sections 1220(a), 1224 and 1245, Business and Professions Code. Reference: Sections 1206, 1209, 1220(a), 1224, 1245, 1265, 1282 and 1285, Business and Professions Code. s 1053.5. HIV Tests. The Department hereby adds to the tests that may be requested and reported pursuant to Business and Professions Code section 1246.5 any laboratory test or examination to identify HIV, a component of HIV, or antibodies or antigens to HIV when the test or examination has been approved by the United States Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit. Note: Authority cited: Sections 1224 and 1246.5, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1246.5, Business and Professions Code; and Section 120775, Health and Safety Code. s 1054.1. Conditions for Performance. (a) A Respiratory Care Practitioner may engage in clinical laboratory practice by performing a blood electrolyte analysis when all of the following conditions are met: (1) The blood electrolyte analysis is performed on an instrument which is designed to perform both blood gas analysis and blood electrolyte analysis simultaneously or concurrently and from the same blood specimen; (2) The blood electrolyte analysis is performed in a licensed laboratory that: (A) is within a licensed surgical clinic or a licensed general acute care hospital; (B) has a CLIA certificate to perform blood gas analysis and blood electrolyte analysis; and (C) has established and maintains protocols for the performance and reporting of blood gas analysis and blood electrolyte analysis simultaneously or concurrently from the same blood specimen by Respiratory Care Practitioners; (3) The blood electrolyte analysis is performed: (A) under the overall operation and administration of the laboratory director, as required in Section 1029 of the Business and Professions Code; and (B) in conformity with the protocols required in (2)(C), above; and (C) in conformity with the manufacturer's instructions. (4) The Respiratory Care Practitioner: (A) has been trained in accordance with Section 1054.2; and, (B) performs and reports simultaneous or concurrent blood gas analysis and blood electrolyte analysis in compliance with the requirements in (3), above; and (C) meets CLIA testing personnel qualifications for the type and complexity of tests being performed. Note: Authority cited: Section 1224, Business and Professions Code. Reference: Sections 1206, 1209, 1220, 1265, 1282 and 1285, Business and Professions Code. s 1054.2. Training. (a) Prior to performing a blood electrolyte analysis, a Respiratory Care Practitioner shall have completed the following training: (1) instruction by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA, depending on the type and complexity of the tests being performed, in: (A) the operation of each instrument to be used for simultaneous or concurrent blood gas analysis and blood electrolyte analysis by the Respiratory Care Practitioner, including the following: 1. Equipment maintenance and calibration; 2. Method performance including the normal ranges and critical values for each test protocol; 3. Quality Control and Assurance requirements including remedial action and reagent and specimen handling and integrity; and, 4. Clinical significance of test results and clinical applications for simultaneous or concurrent blood gas analysis and blood electrolyte analysis. Note: Authority cited: Section 1224, Business and Professions Code. Reference: Sections 1209, 1220 and 1265, Business and Professions Code. s 1054.5. Conditions for Performance. Note: Authority cited: Sections 1220(a) and 1224, Business and Professions Code. Reference: Sections 1206, 1209, 1220(a), 1265, 1282 and 1285, Business and Professions Code. s 1054.6. Testing Authority for Licensed Psychiatric Technicians, Licensed Vocational Nurses, Licensed Midwives, Certified Nurse Assistants, and Certified Home Health Aides. Note: Authority cited: Section 1224 Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5, and 1209, Business and Professions Code. s 1054.7. Preceptor Program Requirements for Licensed Psychiatric Technicians, Licensed Vocational Nurses, Licensed Midwives, Certified Emergency Medical Technicians II, Paramedics, Certified Nurse Assistants, and Certified Home Health Aides Performing Moderate Complexity Testing on Point-of-Care Laboratory Testing Devices. (a) Prior to the performance of any clinical laboratory test or examination authorized in Business and Professions Code Section 1206.5(b)(11), a licensed psychiatric technician, licensed vocational nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant or certified home health aide shall have been trained by a preceptor in: (1) The operation of each instrument to be used by the licensed psychiatric technician, licensed vocation nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant or certified home health aide including: (A) Each instrument's requirements for maintenance and calibration which shall include training regarding all manufacturer's instructions; (B) Each instrument's performance criteria including the reference ranges, critical values for each test method, and actions to be taken for values outside the analytical range; and (C) Each instrument's quality control and quality assurance protocols, including remedial action and reagent and specimen handling and integrity; and, (2) The clinical significance of test results for each instrument and the clinical application for use of the instruments by licensed psychiatric technicians, licensed vocational nurses, licensed midwives, certified emergency medical technicians II, paramedics, certified nurse assistants or certified home health aides; and, (3) The common physiological conditions of patients that may impact specimen integrity and cause inaccurate test results; and (4) Principles of good laboratory practice including laboratory safety and universal precautions. (b) Prior to the utilization, for patient care, prognosis, monitoring, treatment, or disease prevention, of any clinical laboratory test or examination performed by him or her, a licensed psychiatric technician, licensed vocational nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant, certified home health aide shall have the following experience and shall have been determined to be competent to perform moderate complexity tests by the laboratory director or a person who qualifies as a technical consultant pursuant to Business and Professions Code Section 1209: (1) He or she shall participate in a preceptor program until such time as he or she is able to perform clinical laboratory tests or examinations with results that are consistent with the preceptor's results 90% of the time over 20 separate testing events which taken together, cover the entire range of expected values for the instrument. (2) The experience requirement in subsection (b)(1) shall be met for each instrument to be used by the licensed psychiatric technician, licensed vocational nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant or certified home health aide. Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5, 1209, and 1220, Business and Professions Code. s 1055. Reports. Any report of results issuing from a clinical laboratory operating under the provisions of Chapter 3, Division 2, Business and Professions Code shall show clearly the name of a director of said laboratory. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 1220, 1225, 1284 and 1285, Health and Safety Code. s 1056. Prenatal and Neonatal Blood Typing. For purposes of compliance with Sections 291 and 304 of the California Health and Safety Code, rhesus (Rh) blood typing (as defined in Title 17, California Administrative Code, Chapter 2, Subchapter 1, Group 1, Section 1002, Number 3, [Determination of Rh type]) shall consist of D and if this is negative, D<>u typing. Note: Additional authority cited: Sections 290-293 and 304-305, Health and Safety Code. s 1057. Prenatal Blood Typing Reports. Licensed clinical laboratories or approved public health laboratories performing tests on pregnant women as required by Sections 290 and 291 of the California Health and Safety Code shall provide the requesting physician with a copy of the report to be stamped or imprinted as follows: "State law requires that the woman tested be informed as to the rhesus (Rh) typing test results." Every licensed physician and surgeon or other person engaged in the prenatal care of a pregnant woman, or attending such woman at time of delivery after receiving such report, shall be responsible for notifying the woman tested of the results of the test. s 1060. Definitions: Cytotechnologist License. (a) The definitions in subsections (b) though (i) shall govern the interpretation of this article. (b) "Competency testing service or program" means an organization that has been approved by the Department pursuant to section 1270 of the California Business and Professions Code to administer a cytotechnology competency examination. (c) "Cytotechnologist competency examination" means an examination which evaluates a person's entry level skills and abilities in cytotechnology, including his or her understanding of: (1) the underlying scientific principles, technical and procedural aspects of cytotechnology; (2) the identification of cellular changes in gynecological and non-gynecological specimens through both a written and visual component; (3) cytopreparatory techniques; and (4) cytology laboratory operations; and which include the following subject areas in the following ratios: 48% to 52% female reproductive system (to include both the genital system and breast); 13% to 17% respiratory system; 9% to 12% male and female genitourinary systems; 6% to 10% alimentary system; and 13% to 17% body cavity fluids and other body sites. (d) "Entry Level Skills" means the following skills and abilities expected at career entry: (1) Knowledge and understanding of: (A) the underlying scientific principles as well as the technical and procedural aspects of the examination of cytology specimens; (B) the physiological, biochemical, microbiological, and genetic factors which affect cell health and disease, and the importance of cytology laboratory examinations to medical care; (C) quality assurance sufficient to monitor and to implement quality control programs; (D) the introduction and implementation of new procedures and the evaluation of new instruments; (E) basic management theory and functions. (2) Technical skills so that the examinee is capable of: (A) performing examinations on cytology specimens; (B) exercising initiative and independent judgment in dealing with the broad scope of procedural and technical problems; (C) participating in, or being delegated, the responsibility for decisions involving quality control programs, or reagent purchases; (D) communicating technical or general information to medical, paramedical, or lay individuals; (E) participating in and developing responsibility for the establishment of technical and administrative procedures; (F) supervising technicians, aides, and clerical personnel, as directed; and, (G) providing instruction in the basic theory, technical skills, and application of cytology laboratory procedures. (e) "Examinee" means an individual who meets the following requirements: (1) Has a baccalaureate degree from a college or university accredited by the Western Association of Schools and Colleges or its equivalent with 20 semester hours (30 quarter hours) of biological science, 8 semester hours (12 quarter hours) of chemistry and 3 semester hours (4 quarter hours) of mathematics; and (2) Has completed: (A) A 12-month cytotechnology program accredited by the Council on Accreditation of Allied Health Educational Program (CAAHEP) or its equivalent; or (B) Five years, of at least 40 hours a week, clinical laboratory experience in cytopreparatory techniques, microscopic analysis and evaluation of the body systems within the last ten years. At least two of these years must be subsequent to the completion of the academic component and at least two years must be under the supervision of a licensed physician who is a pathologist certified or eligible for certification by the American Board of Pathology in Anatomic Pathology or has other qualifications acceptable to the competency testing service or program. (f) "Evidence of Satisfactory Performance" means (1) a copy of a document issued to an examinee after January 1, 1993 by a cytotechnology competency testing service or program indicating satisfactory performance by the examinee on a cytotechnologist competency examination; or (2) a copy of a document issued to an individual by the American Society of Clinical Pathologists (ASCP) Board of Registry (BOR) indicating satisfactory performance by the individual on an ASCP Cytotechnology Examination taken prior to the approval of a competency testing service or program under the provisions of this article. (g) "Satisfactory performance" means (1) receipt of a passing score on a cytotechnologist competency examination given after January 1, 1993; or (2) passage of an ASCP Cytotechnology Examination prior to the approval of a competency testing service or program under the provisions of this article. (h) "Passing score" means a score determined by a cytotechnologist competency testing service or program utilizing the criteria approved by the Department pursuant to section 1062. (i) "Owner(s)" means any person who is a sole proprietor, or holds a partnership interest in, or who is an officer, director, or 5% (five percent) or more shareholder in a corporation which owns an organization that is applying for approval as a cytotechnologist testing service or program. Note: Authority cited: Sections 1224 and 1270, Business and Professions Code. Reference: Section 1270, Business and Professions Code. s 1061. Cytotechnology Licensure. (a) A cytotechnologist license shall be issued to an individual who submits the following to the Department: (1) A verified and complete application as described in subsection (b); (2) Evidence of satisfactory performance; (3) The application fee required under Business and Professions Code Section 1300 and Health and Safety Code Section 116. (b) A complete application for a cytotechnologist license shall include the following verified information on a form, Application for Cytotechnologist License (LAB 124, Rev. 11/93), provided by the Department: (1) Name, address, social security number (optional), and ASCP registration number, if any, of the applicant; and (2) The applicant's education, training and experience in gynecological and non-gynecological cytology including: (A) An official copy of any and all college credits including a statement of any degrees conferred; and (B) Documentation of each of the following, if completed or obtained by the applicant: 1. The completion of a 12 month training program approved by CAAHEP or its equvalent, or 2. The completion of five years of full-time, of at least 40 hours a week, clinical laboratory experience in cytology; 3. ASCP registration certificate; 4. Licensure by the Department under Business and Professions Code section 1270 subsection (c) or subsection (d); and (3) The name and address of the applicant's current laboratory employer(s), and the number of hours employed (by each) and the time devoted, and volume of types of specimens examined at each location. (c) Within 30 calendar days of receipt of an application for a cytotechnologist license, the Department shall inform the applicant in writing that the application is either complete and accepted for filing or that it is incomplete and what specific information is required before the application may be accepted for filing. (d) Within 90 calendar days from the date the Department receives the information and documentation required in subdivision (a), it shall inform the applicant in writing whether a cytotechnologist license shall be issued or denied. If a license is denied, the Department shall indicate the reasons therefor. (e) The Department's time periods for processing an application for cytotechnologist license, from receipt of the initial application to the final decision regarding the license, are as follows: (1) The median time for processing is 240 calendar days. (2) The minimum time for processing is 120 calendar days. (3) The maximum time for processing is 360 calendar days. (f) Each licensed cytotechnologist shall notify the Department within 30 calendar days of any and all changes in his or her employment, including any changes in the name and address of his or her employer(s), the hours employed by each, and the information specified in subsection (b)(3) above. Note: Authority cited: Sections 1224, 1270 and 1271(f), Business and Professions Code. Reference: Sections 1270, 1271 and 1300, Business and Professions Code; Section 15376, Government Code; and Section 116, Health and Safety Code. s 1062. Cytotechnologist Competency Testing Services Or Programs. (a) Any organization seeking approval by the Department as a cytotechnologist competency testing service or program shall submit an application to the Department which shall include documentation of the following: (1) The organization's name, address, and owner(s); (2) The organization's mechanism for assuring that each individual for whom a cytotechnologist competency testing examination is administered meets the criteria as an examinee; (3) The organization's mechanism for assuring that each cytotechnologist competency examination administered by the organization shall test each examinee on his or her entry level skills and understanding of: (A) The underlying scientific principles and the technical and procedural aspects of cytology; (B) The identification of cellular changes in gynecologic and non-gynecologic specimens through both a written and visual component; (C) Cytopreparatory techniques; and (D) Cytology laboratory operations, and that each test shall include the following subject areas in the following ratios: 48% to 52% female reproductive system (to include both genital system and breast); 13%-17% respiratory system; 9%-12% male and/or female genitourinary system; 6%-10% alimentary system; and 13%-17% body cavity fluids and other body sites; (4) The organization's mechanism for determining the validity and passing score for each cytotechnologist competency examination administered by the organization in order that there is a consistency between and among all testing events as to entry level skills that must be demonstrated in order for an examinee to pass the examination; and, (5) The organization's mechanism for assuring the security of each cytotechnologist competency examination administered by it. (b) Upon receipt of the above, and the determination by the Department that the documentation provides assurances of the following, the Department shall approve the organization as a cytotechnologist competency testing service or program and shall issue an approval document indicating the terms of the organization's approval: (1) The organization shall only administer cytotechnologist competency examinations to persons who qualify as an examinee; (2) Each cytotechnologist competency examination administered by the organization shall challenge each examinee on his or her entry level skills and understanding of the subjects, and shall contain the subject matter in the ratios identified in subsection (a) (3), above; (3) Each cytotechnologist competency examination administered by the organization shall be validly constructed and have a passing score that fosters a consistency between and among all testing events as to entry level skills that must be demonstrated in order for an examinee to pass the examination; and, (4) Each cytotechnologist competency examination shall be administered in a secure fashion. (c) Within 15 days of receipt of an application by an organization for approval as a cytotechnologist competency testing service, the Department shall inform the organization in writing that the application is complete and accepted for review or deficient and what specific information or documentation is required to complete the application. (d) Within 30 calendar days from the date of filing of a completed application, the Department shall inform the applicant organization in writing whether the organization has been approved as a cytotechnologist competency testing service or program. (e) The Department's time periods for processing an application for approval as a cytotechnologist competency testing service or program, from the receipt of the initial application to the final decision regarding the approval, are as follows: (1) The median time for processing is 90 calendar days. (2) The minimum time for processing is 45 calendar days. (3) The maximum time for processing is 135 calendar days. (f) Cytotechnologist competency testing services or programs shall issue a document to each examinee who obtains a passing score on each cytotechnologist competency examination administered by the service or program. (g) Cytotechnologist competency testing services or programs shall maintain, for a minimum of five years, and shall make available to the Department, records showing the validation, content, passing score, date and place of each competency testing examination administered by it, and a record of each examinee tested. (h) A cytotechnologist competency testing service or program shall be subject to review by the Department to determine adherence to the requirements of this article and its approval. Failure of a cytotechnologist competency testing service or program to meet the requirements of this article or its terms of approval shall constitute good cause for revocation of approval by the Department. Note: Authority cited: Sections 1224 and 1270, Business and Professions Code. Reference: Section 1270, Business and Professions Code; and Section 15376, Government Code. s 1065. Imposition of Sanctions. (a) The department may impose, as applicable, one or more of the following sanctions on a clinical laboratory, a public health laboratory or a provider of service: (1) Principal sanctions. (2) Intermediate sanctions. (3) Alternative sanctions. (4) Automatic suspension of a license or registration based on federal exclusion from the Medicare or Medicaid program or revocation of CLIA certificate. (5) State-initiated exclusions from the Medicaid and Medi-Cal programs. (6) Exclusion from ownership or operation for two years following license or registration revocation. (7) Civil suit to enjoin statutory or regulatory violations. (8) Criminal sanctions for unlawful activity. (9) Automatic revocation of license/registration or other approval based on intentional referral of proficiency testing samples for analysis. (10) Suspension of Medi-Cal and Medicaid payments for failure to permit an inspection. (b) The department's decision to impose sanctions shall be based on one or more of the following: (1) Deficiencies found by the department or its agents in the conduct of inspections or through review of materials submitted by a laboratory (e.g., personnel qualifications). (2) Unsuccessful participation in proficiency testing. (c) The department shall base its choice of sanction or sanctions to impose on consideration of one or more factors that include, but are not limited to, the following, as assessed by the department or its agents: (1) Whether the deficiencies pose immediate jeopardy. (2) The nature, incidence, severity, and duration of the deficiencies or noncompliance. (3) Whether the same condition level deficiencies have been identified repeatedly. (4) The accuracy and extent of laboratory records (e.g., of remedial action) in regard to the noncompliance, and their availability to the department, to its agents, or to the United States Health Care Financing Administration and its agents. (5) The relationship of one deficiency or group of deficiencies to other deficiencies. (6) The overall compliance history of the laboratory. (7) The corrective and long-term compliance outcomes that the department hopes to achieve through application of the sanction. (8) Whether the laboratory has made any progress toward improvement following a reasonable opportunity to correct deficiencies. (d) The department shall impose a separate sanction for each condition level deficiency or a single sanction for all condition level deficiencies that are interrelated and subject to correction by a single course of action. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1065.5. Principal Sanctions. (a) The department may impose on a clinical laboratory the principal sanctions of denial, revocation or suspension of a registration or license issued under chapter 3 of division 2 of the Business and Professions Code whenever it determines that any of the grounds identified in Business and Professions Code section 1320 exist and it has complied with the requirements of Business and Professions Code sections 1267 and 1322. A clinical laboratory that has had a Statement of Issues or an Accusation filed against it for the denial, revocation or suspension of its license or registration may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. A clinical laboratory that is dissatisfied with a final decision regarding a denial, revocation or suspension may seek judicial review in accordance with section 11523 of the Government Code. (b) The department may impose on a public health laboratory the principal sanctions of denial, revocation or suspension of the approval to operate a public health laboratory granted under article 5 (commencing with section 101150) of the Health and Safety Code whenever it determines that the requirements identified in 17 CCR section 1078 are not being met and it has complied with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code. A public health laboratory that has had a Statement of Issues or an Accusation filed against it for the denial, revocation or suspension of its approval to operate may defend itself by filing a notice of defense in accordance with section 11506 of the Government Code. A public health laboratory that is dissatisfied with a final decision regarding a denial, revocation or suspension may seek judicial review in accordance with section 11523 of the Government Code. (c) The department may impose on a provider of service the principal sanction of suspension from further participation in, including reimbursement from, the Medi-Cal and Medicaid programs whenever it determines that any of the grounds identified in Welfare and Institutions Code section 14123 exist and it has complied with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, except that hearings may be conducted by departmental hearing officers appointed by the director. A provider of service that has had an Accusation filed against it for its suspension from further participation in the Medi-Cal program may defend itself, its owner(s) or director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. A provider of service that is dissatisfied with a final decision regarding suspension from further participation in the Medi-Cal program may seek judicial review in accordance with section 11523 of the Government Code. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1065.10. Intermediate Sanctions. (a) The department may impose on a clinical laboratory the intermediate sanction of temporary suspension of a registration or license issued under chapter 3 of division 2 of the Business and Professions Code based on a departmental finding of immediate jeopardy or other grounds identified in Business and Professions Code section 1323. The intermediate sanction becomes effective upon the serving of an Accusation. A clinical laboratory that has had an Accusation filed against it for temporary suspension of its license or registration may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 1323 of the Business and Professions Code. Regardless of a notice of defense being filed, the temporary suspension remains in effect at least until the hearing is completed and the department has made a final determination on the merits. A clinical laboratory that is dissatisfied with a final determination on the merits may seek judicial review in accordance with section 11523 of the Government Code. (b) The department may impose on a public health laboratory the intermediate sanction of temporary suspension of the approval to operate a public health laboratory granted under article 5 (commencing with section 101150) of the Health and Safety Code based on a departmental finding of immediate jeopardy. The intermediate sanction becomes effective upon the serving of an Accusation. A public health laboratory that has had an Accusation filed against it for temporary suspension of its approval may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. Regardless of a notice of defense being filed, the temporary suspension remains in effect at least until the hearing is completed and the department has made a final determination on the merits. A public health laboratory that is dissatisfied with a final determination on the merits may seek judicial review in accordance with section 11523 of the Government Code. (c) The department may impose on a provider of service the intermediate sanction of temporary suspension from participation in, including reimbursement from, the Medi-Cal and Medicaid programs based on a departmental finding of immediate jeopardy or condition level deficiencies and when in the opinion of the director of the department such action is necessary to protect the public welfare or the interests of the Medi-Cal program. The intermediate sanction becomes effective upon the serving of an Accusation. A provider of service that has had an Accusation filed against it for temporary suspension from participation in the Medi-Cal program may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. Regardless of a notice of defense being filed, the temporary suspension remains in effect at least until the hearing is completed and the department has made a final determination on the merits. A provider of service that is dissatisfied with a final determination on the merits may seek judicial review in accordance with section 11523 of the Government Code. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1065.15. Alternative Sanctions. (a) The department may impose on a clinical laboratory one or more of the following alternative sanctions in lieu of or in addition to imposing a principal sanction: (1) Directed plans of correction, as set forth in section 1067. (2) Onsite monitoring, as set forth in section 1067.10. (3) Civil money penalties, as set forth in section 1067.5. (b) Prior to the imposition of an alternative sanction a clinical laboratory shall be given a Notice of Intent and an opportunity to respond. A clinical laboratory that is dissatisfied with the imposition of an alternative sanction may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1065.20. Automatic Suspension. The department shall automatically suspend a clinical laboratory license or registration based on federal exclusion from the Medicare or Medicaid program or revocation of CLIA certificate. A clinical laboratory that is dissatisfied with the imposition of an automatic suspension may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1065.25. State-Initiated Exclusions from Medicaid and Medi-Cal. The department may initiate exclusions from Medicaid and Medi-Cal when the grounds for taking a permissive exclusion under 42 CFR part 1002 exist. The department shall initiate exclusions from Medicaid and Medi-Cal when the grounds for taking a mandatory exclusion under 42 CFR part 1002 exist. Before imposing an exclusion, the department shall give a provider of service an opportunity to submit documents and written argument against the exclusion. A provider of service that is dissatisfied with the imposition of an exclusion may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1065.30. Exclusion from Ownership or Operation. The department shall exclude for a period of two years following revocation any person or entity from owning, operating, or directing a laboratory, whenever the person or entity has been the owner, operator or laboratory director of a clinical laboratory that has had its clinical laboratory license or registration revoked. A person or entity that is dissatisfied with the imposition of an exclusion from owning or operating a clinical laboratory may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1065.35. Civil Suit to Enjoin Violations. The department shall initiate a civil suit whenever such suit is necessary to enjoin the violation or threatened violation of chapter 3 (commencing with section 1200) of the Business and Professions Code or the regulations adopted thereunder. A person or entity against whom a civil suit is filed shall have all the rights of defense afforded by California civil law. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1065.40. Criminal Sanctions for Unlawful Activity. The department may refer for prosecution to the Attorney General's office or a District Attorney's office, when appropriate, any person or entity it has reason to believe has engaged in any of the unlawful activities identified in sections 1280 through 1287, inclusive of the Business and Professions Code. A person or entity against whom a criminal action is filed shall have all the rights of defense afforded by California criminal law. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC , Section1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1065.45. Revocation for Referral of Proficiency Testing Samples. If the department determines that a laboratory has intentionally referred proficiency testing samples to another laboratory for analysis, it shall take action to revoke the license/registration or other approval for at least one year and may take action to impose any other available sanction. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840. s 1066. Condition Level Requirements. (a) Any requirement specified in subsections (b) through (i) shall constitute a condition level requirement. (b) Each clinical laboratory performing clinical laboratory tests or examinations classified as of moderate or of high complexity under CLIA shall obtain and maintain a valid clinical laboratory license issued pursuant to section 1265 of the Business and Professions Code. (c) Each clinical laboratory shall employ: (1) A sufficient number of laboratory personnel with the appropriate education and either experience or training to: (A) Provide appropriate direction, supervision and consultation; (B) Accurately perform tests; and (C) Report test results. (2) Laboratory personnel who meet the personnel qualifications, duties, and responsibilities required in CLIA and sections 1203, 1204, 1206.5, 1207, 1209, 1209.1, 1210, 1270 and 1271 of the Business and Professions Code. (d) Each clinical laboratory shall: (1) Enroll in a proficiency testing program approved by the department or by the United States Health Care Financing Administration if required to enroll under Business and Professions Code section 1220(a)(2)(A); and if required to enroll, demonstrate successful participation, as defined under CLIA, for each specialty and subspecialty in which it performs clinical laboratory tests or examinations, to the same extent as required under CLIA, (2) Authorize its proficiency test results to be reported to the department in an electronic format that is compatible with the department's proficiency testing data monitoring system, and (3) Authorize the release of proficiency tests results to the public to the same extent required by CLIA. (e) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(A) shall establish and maintain a patient test management system that meets the standards of CLIA; (f) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(B) shall: (1) Establish and maintain a quality control program that meets the requirements of CLIA, (2) Perform all clinical laboratory tests or examinations classified as waived under CLIA in conformity with the manufacturer's instructions. (g) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(C) shall: (1) Establish and maintain a comprehensive quality assurance program that meets the standards of CLIA, (2) Maintain records, equipment, and facilities that are adequate and appropriate for the services rendered, (3) Be conducted, maintained and operated without injury to the public health, and (4) If providing cytology services and its licensee ceases operation, preserve (A) Records, (B) Reports, (C) Cytology slides, and (D) Cell blocks as prescribed in subdivision (g) of section 1271 and section 1274 of the Business and Professions Code. (h) Each licensed or registered clinical laboratory shall submit to the inspections identified in Business and Professions Code section 1220, which inspections may be conducted by department employees or contractors, or the United States Health Care Financing Administration (HCFA), or HCFA agents. The department may conduct announced or unannounced inspections of any premises, building, equipment, materials, records, or information at any reasonable time to secure compliance with, or prevent a violation of chapter 3 of division 2 of the B&P Code. A clinical laboratory shall permit, as part of this inspection, the department or its contractors or agents to: (1) Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of chapter 3 of division 2 of the Business and Professions Code or the regulations adopted pursuant thereto. (The laboratory shall make all records and data accessible and retrievable within a reasonable time frame during the course of the inspection.); (2) Secure any sample, photograph, or other evidence from any building or premises for the purpose of enforcing chapter 3 of division 2 of the Business and Professions Code or the regulations adopted pursuant thereto; (3) Observe laboratory personnel performing tests (including proficiency testing), data analysis and reporting; (4) Interview all personnel of the clinical laboratory concerning compliance with chapter 3 of division 2 of the Business and Professions Code and the regulations adopted thereunder; (5) Upon request, review all information and data necessary to: (A) Determine that testing is being performed or the laboratory is being operated in a manner that does not constitute an imminent and serious risk to public health; (B) Evaluate complaints from the public; and (C) Determine whether or not the laboratory is performing tests without a license or registration applicable to the category of tests or examinations being performed; and (6) Provide copies to the department or its contractors or agents of all records and data required under chapter 3 of division 2 of the Business and Professions Code and the regulations adopted thereunder. (i) Each laboratory shall comply with the requirements identified as "conditions" in subparts G through P of CLIA. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, Chapter 510, Section 1. Reference: Statutes 1995, Chapter 510, Section 1; and Sections 1203, 1204, 1206.5, 1207, 1209, 1209.1, 1210, 1220, 1223, 1225 and 1265, Business and Professions Code. s 1067. Procedures for the Imposition of Directed Plans of Correction. (a) The department may impose a directed plan of correction as an alternative sanction for any clinical laboratory that has condition level deficiencies. (b) If the department is imposing a directed plan of correction, the following procedures shall apply: (1) The department shall give the laboratory a written Notice of Intent to impose a directed plan of correction. The Notice of Intent shall include the following: (A) The condition level deficiency that has been identified, (B) The sanction or sanctions that the department proposes to impose against the laboratory, (C) The rationale for the proposed sanction or sanctions, (D) The projected effective date and duration of the proposed sanction or sanctions, (E) The authority for the proposed sanction or sanctions, and (F) The time allowed for the laboratory to respond to the notice. (During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.) (2) After the period specified in (b)(1)(F) has elapsed, the department shall give the laboratory a written Notice of Sanction to impose a Directed Plan of Correction that acknowledges any evidence or information received from the laboratory and specifies the following: (A) The sanction or sanctions to be imposed against the laboratory, (B) The authority and rationale for imposing the sanction or sanctions, (C) The effective date and duration of sanction, and (D) A direction to the laboratory to take specific corrective action within specific time frames in order to achieve compliance. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Sections 11503, 11505 and 11506, Government Code. s 1067.5. Procedures for the Imposition of Civil Money Penalties. (a) The department may impose civil money penalties as an alternative sanction for any clinical laboratory that has condition level deficiencies. (b) If the department is imposing civil money penalties, the following procedures apply: (1) In determining the amount of the penalty, the department shall take into account the following factors: (A) The nature, scope, severity, and duration of the deficiency or noncompliance. (B) Whether the same condition level deficiencies have been identified during prior inspections. (C) The laboratory's intent or reason for noncompliance. (D) The accuracy and extent of laboratory records and their availability to the department or its contractors or agents. (2) For a condition level deficiency that does not pose immediate jeopardy, the range of the penalty amount shall be $50-$3,000 per day of noncompliance or per violation. The department may, before any hearing, propose to increase the penalty amount into the range specified in (b)(3) for a laboratory that has deficiencies which, after imposition of a lower penalty amount, become sufficiently serious to pose immediate jeopardy. (3) For a condition level deficiency that poses immediate jeopardy, the range of the penalty shall be $3,050-$10,000 per day of noncompliance or per violation. If the immediate jeopardy is removed, but the deficiency continues, the department shall shift the penalty amount to the range specified in (b)(2). (4) The department shall send the laboratory written notice of intent to impose a civil money penalty. The notice shall include the following information: (A) The statutory basis for the penalty, (B) The proposed daily or per violation amount of the penalty, (C) The factors (as described in paragraph (b)(1) of this section) that the department considered, and (D) The time allowed for the laboratory to respond to the notice. (During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.) (5) After the period specified in (b)(4)(D) has elapsed, the department shall give the laboratory a written Notice of Sanction that acknowledges any evidence or information received from the laboratory and specifies the following: (A) The sanction or sanctions to be imposed against the laboratory, (B) The authority and rationale for imposing the sanction or sanctions, (C) The effective date and duration of sanction, and (D) A specific statement regarding the laboratory's appeal rights and a Notice of Defense in the following form: Unless a written request for a hearing signed by the laboratory owner(s) or director(s) is delivered or mailed to the department within 15 days after the Notice of Sanction was mailed, the department may proceed upon imposition of the sanctions identified in the Notice of Sanction without a hearing. A request for a hearing may be made by delivering or mailing the enclosed form entitled Notice of Defense, or by delivering or mailing a notice of defense as provided by section 11506 of the Government Code to: The Department of Health Services at the address noted on the Notice of Sanction. The laboratory may, but need not, be represented by counsel at any or all stages of the proceedings. (6) The laboratory shall have 15 days from the date of receipt of the Notice of Sanction to request a hearing by delivering or mailing a Notice of Defense. Hearings shall be conducted in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, except that hearings may be conducted by departmental hearing officers appointed by the director. (7) The effective date of an alternative sanction of a civil money penalty shall be delayed if the laboratory has appealed and the hearing or the hearing decision is pending. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Section 11505, Government Code. s 1067.10. Procedures for the Imposition of On-site Monitoring. (a) The department may require continuous or intermittent monitoring of a plan of correction to ensure that the laboratory makes the improvements necessary to bring it into compliance with the condition level requirements. (b) The laboratory shall pay the costs of on-site monitoring by the department. (c) If the department imposes on-site monitoring, the following procedures apply: (1) The department shall provide written notice of the following: (A) The condition level noncompliance that it has identified, (B) The sanction or sanctions that the department proposes to impose against the laboratory, (C) The rationale for the proposed sanction or sanctions, (D) The projected effective date and duration of the proposed sanction or sanctions, (E) The authority for the proposed sanction or sanctions, and (F) The time allowed for the laboratory to respond to the notice. [During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.] (2) After the period specified in (c)(1)(F) has elapsed, the department shall give the laboratory written notice that acknowledges any evidence or information received from the laboratory and specifies the following: (A) The sanction or sanctions to be imposed against the laboratory, (B) The authority and rationale for imposing the sanction or sanctions, and (C) The effective date and duration of sanction. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Sections 11503, 11505 and 11506, Government Code. s 1067.15. Procedures for the Imposition of a Temporary Suspension of a Laboratory or Clinical Laboratory under the Medi-Cal Program. (a) The department may impose a Temporary Suspension on a provider of laboratory services prior to hearing if the laboratory has condition level deficiencies or there is immediate jeopardy and in the director's opinion such action is necessary to protect the public welfare or the interests of the Medi-Cal program. (b) If the department is imposing a Temporary Suspension on a provider of service, the following procedures apply: (1) The department shall serve the laboratory with a Notice of Sanction which includes the following information: (A) The sanction or sanctions to be imposed against the laboratory, and (B) The effective date and duration of sanction. (2) At the same time as the Notice of Sanction is served, the department shall serve the laboratory with an Accusation. Included with the Accusation is a Notice of Defense in the following form: Unless a written request for a hearing signed by the owner(s) or director(s) of the laboratory is delivered or mailed to the department within 15 days after the Notice of Sanction and Accusation were served, no hearing shall be held regarding the imposition of the sanctions identified in the Notice of Sanction. A request for a hearing may be made by delivering or mailing the enclosed form entitled Notice of Defense, or by delivering or mailing a notice of defense as provided by section 11506 of the Government Code to: The Department of Health Services at the address noted on the Notice of Sanction. The laboratory may, but need not, be represented by counsel at any or all stages of these proceedings. (3) The laboratory shall have 15 days from the date of receipt of the Notice of Sanction to request a hearing by delivering or mailing a Notice of Defense. Hearings shall be conducted in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, except that hearings may be conducted by departmental hearing officers appointed by the director. (4) The effective date of a Temporary Suspension of a clinical laboratory or laboratory under the Medi-Cal program shall not be delayed because the laboratory has appealed the sanction under (b)(3), above, and the hearing or the hearing decision is pending. Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 14105, Welfare and Institutions Code. Reference: Stats. 1995, c.510, Section 1; Section 1265, Business and Professions Code; Section 14123, Welfare and Institutions Code; 42 United States Code, Section 1395w-2 (Section 1846 of the federal Social Security Act); 42 United States Code, Section 1396a(a)(9) (Section 1902(a)(9)(C) of the federal Social Security Act); and Sections 11503, 11505 and 11506, Government Code. s 1075. Local Health Departments. Each local health department shall have available the services of an official public health laboratory. The laboratory of the State Department of Health is hereby designated as the official laboratory for all local health department jurisdictions not covered by local laboratory service. Note: Authority cited for Article 1: Sections 208, 1000, and 1002 of the Health and Safety Code. Reference: Sections 1000 and 1002, Health and Safety Code. Issuing agency: State Department of Public Health. s 1076. Certificates of Approval Required. A certificate of approval issued after inspection by the Department shall be required to be in the possession of and be on display in every principal and branch public health laboratory and no such laboratory shall continue to operate following receipt of notice of cancellation of any existing certificate, or of refusal of the Department to issue a certificate. s 1076.1. Public Health Laboratory. The official public health laboratory shall consist of a principal public health laboratory and may include branch public health laboratories. (a) The principal public health laboratory is the laboratory facility that provides the major or total laboratory services to a public health department. (b) A branch public health laboratory is any laboratory facility that provides minor or auxiliary laboratory services. Note: Authority cited: Sections 208, 1000 and 1002, Health and Safety Code. Reference: Sections 1000 and 1002, Health and Safety Code. s 1077. Reports Required. The following reports shall be transmitted to the Department by all laboratories approved under Section 1076. Standard forms shall be used if provided by the Department. (a) A report shall be made semiannually during the months of January and July, of work load data and personnel information as requested by the Department. (b) A report shall be given within 30 days: (1) Of any change in the directorship of the laboratory. (2) Of any proposed expansion, reduction or shift in laboratory services. (3) Of any change in the location of the laboratory. (c) Such additional reports shall be made as required by the Department. Note: Authority cited: Sections 208 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code. s 1078. Minimum Requirements Specified. Any laboratory approved under Section 1076 shall meet the following minimum requirements: (a) Maintain adequate equipment and facilities and sufficient personnel to carry on dependable public health laboratory work. (b) Employ procedures, technics, and reporting practices approved by the Department. (c) Establish and maintain for a minimum of two years adequate record systems and files of laboratory work done. (d) Conduct, maintain, and operate programs, acceptable to the Department, for controlling the quality of test performance. (e) Demonstrate satisfactory performance in a proficiency testing program approved by the Department. (f) Maintain and conduct the laboratory in a manner approved by the Department. (g) Employ personnel as provided in this article. (h) Accept specimens for examination as an aid to patient management only from, and issue reports only to, persons licensed under the provisions of the law relating to the healing arts or their representatives. (i) Employ procedures and precautions to provide for the safety and health protection of all persons in the laboratory. s 1079. Professional Personnel to Be Certified. (a) No person may act as a Public Health Microbiologist in any laboratory certified under Section 1076 who is not in possession of a Public Health Microbiologist's Certificate issued by the Department. (b) The Department may issue temporary certificates to applicants who meet the requirements for admission to the next scheduled examination when this is deemed to be reasonably necessary for the provision of public health laboratory services. Temporary certificates may not be issued to applicants who have failed to pass certification examinations. (c) Examinations, either written or oral, or both, for the certificate of Public Health Microbiologist shall be held as needed and where designated by the Department. Such examinations shall be under the supervision of the Department. (d) The minimum requirements for admission to the examinations for a certificate as Public Health Microbiologist shall be as follows: (1) Holds an earned doctoral degree from an accredited institution with a chemical, physical or biological science as a major, and has completed at least one year of postdoctoral laboratory training in medical and public health microbiology approved by the Department; or (2) A baccalaureate or higher degree with a major in Medical or Public Health Microbiology, or equivalent major as determined by the Department, with courses acceptable to the Department, from a college or university accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the Department; and experience represented by at least six months as a Public Health Microbiologist-trainee in a public health laboratory approved by the Department for such training; or experience equivalent to this training as determined by the Department in a laboratory acceptable to the Department. (e) No person shall perform any test or make any examination in any laboratory certified under Section 1076 unless he is in possession of a valid Public Health Microbiologist's certificate or is otherwise approved by the Department to perform specified laboratory procedures. (f) Every person certified as a Public Health Microbiologist shall report to the Department within 30 days any change of name or mailing address giving both the old and new names and addresses. (g) Certificates may be denied, revoked or suspended for any of the following reasons: (1) Conviction of a felony or of any misdemeanor involving moral turpitude, under laws of any State or of the United States, arising out of or in connection with public health laboratory practice. The record of conviction or a certified copy thereof shall be conclusive evidence of such conviction. (2) Violation of any provision of the Business and Professions Code governing the practice of medicine and surgery. (3) Violation of these regulations. (4) Knowingly making a false statement concerning a material matter on an application for certification, or on an application for approval as a trainee. (5) The use of any degree, certificate or title in any manner, which has been purchased or procured by barter or any unlawful means or obtained from any institution which at the time said degree, certificate or title was obtained was not recognized or accredited by the proper authorities of the state where said institution was located to give training in the field of study in which the degree, certificate or title is claimed. (6) The use of drugs or alcoholic beverages to the extent, or in such a manner, that such use impairs the ability of the certified person to practice his profession with safety to other persons in the laboratory or to the public. (h) Proceedings under paragraph (g) above shall be conducted in accordance with Chapter 5, Part 1, Division 3 of Title 2 of the Government Code. Note: Authority cited: Section 1224, Business and Professions Code; Section 208, Health and Safety Code. Reference: Section 1270, Business and Professions Code; Section 1002, Health and Safety Code. s 1080. Professional Training. (a) For purposes of this section a person receiving professional training required for certification as a Public Health Microbiologist shall be designated as a Public Health Microbiologist-trainee. (b) The credentials of a Public Health Microbiologist-trainee shall be approved by the Department prior to appointment. (c) The appointment or separation of a Public Health Microbiologist-trainee shall be reported within 5 days to the Department giving the date of appointment or separation. (d) Laboratories which accept personnel for training as Public Health Microbiologist-trainees shall be specifically approved for such training by the Department. The minimum requirements for approval as training laboratories shall be established by the Department. (e) A Public Health Microbiologist-trainee shall not be entrusted with any microbiological examination except under the supervision of qualified personnel, nor shall he issue or sign a laboratory report for any test which he is scheduled for training for certification as a Public Health Microbiologist. s 1081. Certain Cultures and Specimens to Be Sent to the State Laboratory. (a) All laboratories making examinations for identification of typhoid carriers shall, in all positive cases, forward to the Department a culture of the organism, the isolation of which established the diagnosis. (b) Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human cases of plague or botulism such laboratory shall communicate immediately by telephone or telegraph with the Department for instructions. (c) Any other specimens or cultures shall be submitted as required by the communicable disease regulations, Sections 2500 to 2699. s 1082. Certain Specimens to Be Sent to Approved Laboratories. Whenever specimens are taken for laboratory diagnosis of rabies or botulism, or for release from isolation of cases of diphtheria, typhoid fever, salmonellosis, or shigellosis, they shall be sent by the physician to a Public Health Laboratory approved for such work by the Department in accordance with Section 1076. s 1083. Inspections to Be Made. Laboratories approved under Section 1076 shall be inspected by a duly authorized representative of the Department, for maintenance and conduct in conformity with these regulations. When deemed advisable, the Department may send check specimens to local laboratories to evaluate the accuracy and precision of specific test performance. s 1084. Health Departments May Contract with Private Laboratories. A health officer of a municipality or county may designate any laboratory as an official public health laboratory to perform any of the basic services, as defined under Section 1276(f). Any such laboratory shall be subject to the same requirements as an official public health laboratory as heretofore provided under Sections 1075 to 1083, inclusive. s 1125. Application Required. The director of any laboratory in which performance of serologic tests is planned in connection with premarital and prenatal examinations, as required by Sections 4300-4309 of the Civil Code and Sections 3220-3229 of the Health and Safety Code, shall apply to the State Department of Health for approval to perform these tests. The laboratory director shall submit to the State Department of Health, on forms provided by the department, such information as may be required by the department to satisfactorily evaluate the personnel, equipment, and scope of activity in relation to these tests. Note: ss 1125 to 1134, inclusive, originally issued under authority contained in Section 79.04, Civil Code, and Deering's General Laws, Act 6265. Source ofss 1125 to 1134, inclusive, is the Rules and Regulations issued by State Department of Health. Additional authority cited for revision of Article 1: Sections 102 and 208, Health and Safety Code. Reference: Sections 3180-3199 and 3220-3229, Health and Safety Code. s 1126. Approved Tests. The serologic tests for syphilis approved by the Department for use in connection with legally required premarital and prenatal examinations are as follows: VDRL slide, Automated Reagin, Fluorescent Treponemal Antibody (absorption), Reagin Screen, and the Rapid Plasma Reagin (circle) Card. Any one of these tests shall constitute the "standard test" as required by the California Civil Code and California Health and Safety Code. The serologic tests for rubella approved by the department for use in connection with legally required premarital examinations shall be the hemagglutination-inhibition (HI) test performed according to the standard method of the U.S. Public Health Service, Center for Disease Control, or modifications thereof approved by the Center for Disease Control and the Department, and such other tests approved by the Center for Disease Control and Food and Drug Administration, U.S. Public Health Service, as the Department may evaluate and determine to be equal in reliability and specificity to the approved hemagglutination-inhibition test. Commercially prepared antigens and diagnostic kits utilized for the approved rubella tests shall have been evaluated by, and shown to meet specifications of the U.S. Public Health Service and such evaluation shall be evidenced by a statement on the label of, or accompanying, the product. Note: Authority cited: Section 11426, Government Code; Sections 4300, 4301, 4302 and 4304, California Civil Code; Sections 102 and 208, Health and Safety Code. Reference: Sections 3180-3199 and 3220-3229, Health and Safety Code. s 1127. Method of Conducting Tests. All tests for syphilis must be conducted exactly as outlined by the author of the test. All equipment recommended by the author of the test must be available in the laboratory before approval can be granted. For syphilis serology, the latest United States Department of Health, Education and Welfare, Public Health Service publication pertaining to the performance of these tests, or its replacement, shall be the reference on equipment and methods. All tests for rubella must be conducted exactly according to the protocols for each method or modification that has been approved by the Center for Disease Control and the Department. All necessary equipment for the approved rubella test to be performed must be available in the laboratory before approval to perform legally required tests can be granted. The references for approved rubella test methods and equipment shall be protocols issued by the Center for Disease Control, or the Department, or provided by manufacturers for use with commercially distributed diagnostic kits or components which have been approved by the Center for Disease Control and the Department. s 1128. Evaluation Sera. Any laboratory approved to perform premarital and prenatal serologic tests must accept and test, evaluation sera provided by the department or a proficiency testing service approved by the department, and report test results to the department. Any laboratory showing unsatisfactory performance shall make changes as recommended by the department or discontinue the testing of legally required premarital and prenatal blood specimens, and return all outstanding "Marriage Health Certificates." s 1129. Marriage Health Certificates. "Marriage Health Certificates" shall be assigned by the State Department of Public Health to an individual laboratory at a specified location, and shall be used by no other. These certificates must not be transmitted to the physician until the tests have been performed. s 1130. Persons Permitted to Perform Tests. Only a person who is duly licensed as a physician and surgeon pursuant to Sections 2000-2497 of the Business and Professions Code, or duly authorized under the provisions of Chapter 3, Division 2 (commencing with Section 1200) of the Business and Professions Code, or who is certified under the provisions of Sections 1075-1084 of Title 17 of the California Administrative Code, shall be permitted to conduct premarital and prenatal serologic tests. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 3220, 4300 and 4302, Health and Safety Code. s 1131. Change of Personnel. Within 30 days after new personnel are employed to perform legally required prenatal and premarital serologic tests, their names shall be transmitted to the State Department of Health. This rule does not apply to the rotation of staff members from one phase of laboratory work to another. s 1132. Change of Director or Location. Reapplication for approval to perform legally required premarital and prenatal serologic tests shall be made when there is a change of laboratory director or location. s 1133. Advertising Prohibited. Laboratories shall not be approved to perform premarital and prenatal serologic tests if they advertise the performance of these tests to the lay public. s 1134. Withdrawal of Approval. Approval granted under this article may be withdrawn following violation of any of the provisions of Sections 1125-1134 of Title 17 of the California Administrative Code, Sections 3220-3229 of the Health and Safety Code, Sections 4300-4309 of the Civil Code pertaining to the performance of premarital and prenatal serologic tests and all outstanding "marriage health certificates" shall be returned to the State Department of Public Health. s 1150. Definitions. (a) For purposes of these regulations, "person" includes: laboratory, firm, association, corporation, copartnership, and educational institution. (b) For purposes of these regulations, "board" means: the State Department of Health Services. (c) For purposes of these regulations, "department" means: the State Department of Public Health. (d) For purposes of these regulations, "animal" means: any live, warm-blooded animal kept or used by any person for the purposes defined herein. (e) For purposes of these regulations, "individual" means: the one whom the laboratory, firm, association, corporation, copartnership or educational institution designates as being responsible for proper care of the animals kept or used for experimentation, demonstration, or test; the propriety of the procedures used; and the scientific justification for the use of the animals in experiments, demonstrations, or tests. s 1151. Issuance of the Certificate of Approval. (a) All persons desiring to keep or use animals for the study, diagnosis, and treatment of human and animal diseases, for education or research in the advancement of veterinary, dental, medical, and biological sciences for education and research in animal and human nutrition, and for the testing and diagnosis, improvement and standardization of laboratory specimens, biologic products, pharmaceuticals and drugs shall make application to the department on the forms provided by the department for a certification of approval for such activities. They shall supply such other information as may be required by the department for the establishment, and its physical facilities with respect to the care of animals as related to the intent and purpose of this law. (b) Certificates of approval shall not be issued to any person unless he is at the time of application prepared and equipped to keep and use the animals in accordance with the provisions of this law, and rules and regulations of the board adopted in accordance thereof. The department will provide anyone contemplating keeping or using animals information concerning the requirements and conditions for the compliance with the law. (c) Each applicant for certification shall designate an individual who will be directly responsible for the use and care of animals and for making appropriate reports thereof. Such individuals shall occupy a responsible position of authority in the applicant organization. A certified institution which transfers such responsibility shall immediately notify the department of such fact. The department may deny any application unless it is satisfied that the responsible individual so designated is qualified and will require that the animals kept or used by the applicant be used and cared for in a humane manner acceptable to this department. (d) A certificate of approval must be obtained for each address or campus where animals are kept or used for the purposes specified in this law. (e) A new application or amendment to existing and approved application must be made for any change of the responsible individual, or change in location of the laboratory or animal quarters. (f) Any major change in equipment or methods of management must be approved in advance by the department. (g) The certificate of approval or duplicate thereof as supplied by the department shall be displayed in a prominent place in the approved animal quarters or approved laboratory. (h) A certificate of approval shall not be issued unless the conditions of the establishment and facilities are such as to reasonably insure that the animals kept or used receive humane care and treatment. (i) Denial, revocation, or suspension of certificates of approval must be in accordance with the provisions of the Administrative Procedure Act. s 1152. Fees. (a) The application and renewal fees must be in accordance with the provisions of Article 5 of Chapter 5 of Division 2 of the Health and Safety Code. (b) For the purpose of these regulations the fiscal year shall be from January 1st to December 31st. s 1153. Application for Renewal of Certificate of Approval. (a) Application for renewal of certificates of approval shall be on forms provided by the department. (b) Each holder of a certificate applying for renewal of his certificate of approval shall be subject to a review of his activities during the previous licensing period and to such inspections of his records, premises, equipment, and animals as may be determined by the department for consideration by the board in passing upon the application for renewal. (c) Similarly, such licensees shall submit such data and records as may be designated by the department. s 1154. Records. Holders of certificates of approval shall keep the following records: (a) Monthly census of animals kept according to type; (b) Total number of animals used per month according to type; (c) Use and disposition of the animals. Such records may be open to inspection by authorized agents of the department during the normal working hours of operation. s 1155. Care and Treatment of Animals. (a) Careful consideration shall be given to the bodily comfort of such animals. They shall be kindly treated, properly fed, and their quarters shall be clean, properly lighted and maintained at the proper temperature. Exception may be made to this rule only with expressed permission of the responsible individual. This permission may be granted only when the foregoing considerations would defeat the purpose of the work. (b) Any operation likely to cause greater discomfort than the attending anesthetization shall not be undertaken until the animal be first rendered incapable of perceiving pain. The animals shall be maintained in that condition until the operation is completed. Exceptions to this rule may be made only when provisions for maximum comfort including anesthesia would defeat the object of the experiment, and then only with the expressed permission of the responsible individual. (c) At the conclusion of experiments, the animals must be killed painlessly or given care to minimize discomfort which is essentially equivalent, as determined by the department, to that rendered human beings following an operation. In any event, animals which have been used for any purpose described herein shall not be disposed of as pets, except with the expressed permission of the responsible individual. Due consideration in this master shall be given to public health and to the animal's welfare. s 1156. Quarters. The animal quarters shall be provided with proper lighting, ventilation, and heating to maintain comfort of the animal except where the provisions of Section 1155 otherwise provide. Equipment must be adequate for the proper care and treatment of all animals kept or used. Cages, or other enclosures, shall be large enough to permit reasonable freedom of movement. Adequate facilities shall be provided for keeping animal quarters and equipment clean. Overcrowding must be avoided in order to limit the transmission of animal diseases. The animals shall be maintained in a room separate from any other activity of the establishment, or under other physical conditions satisfactory to the department. s 1157. Personnel. Capable personnel shall be employed for the adequate care and feeding of the animals. In small, as well as in extensive animal facilities, one individual shall be in complete charge of, and therefore, responsible for, the entire operation of the unit. Selection of animal caretakers shall be made with care. Nonprofessional personnel shall be chosen for their dependability and their liking for animals. The training should include a knowledge of the means of transmission of disease and an understanding of the precautions necessary to prevent this. Caretakers should be trained in recognizing early symptoms of the common diseases of the animals under their care. s 1158. Feeding. (a) The animals shall be well fed and shall receive wholesome food suitable to the species and shall receive sufficient clean water except where special studies require specified diet for the animal. (b) Rules and regulations adopted by the board with reference to shelter, food, sanitation, and the care and treatment of animals shall be prominently displayed in all animal rooms. s 1159. Filing of a Complaint. Anyone who files a complaint to the department against an individual, or person, violating this law shall supply in writing specific information regarding the alleged violation, or violations. Such complaint shall include the time, date, place, individual, or person involved; and the names of other witnesses who may be called to testify. This statement must be in the form of a sworn affidavit and must be notarized. s 1160. Application of Subchapter. Group 5.5 shall apply to all laboratories performing urine testing or other body fluids analysis for methadone programs operating in California. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1161. Methadone Drug Analysis. "Methadone drug analysis" means the practical application of specialized devices, instruments and methods by trained laboratory personnel to detect the presence of chemical substances named in Section 1186 in samples of urine or other body fluids obtained from persons receiving treatment from a methadone program. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1162. Methadone Drug Analysis Laboratory. "Methadone drug analysis laboratory" means a place at which specialized apparatus, instruments and methods are used by trained laboratory personnel to detect the presence of chemical substances named in Section 1186 in urine or other body fluids obtained from persons receiving treatment from a methadone program. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1163. Methadone Drug Analysis Supervisor. "Methadone drug analysis supervisor" means a person, employed by a methadone drug analysis laboratory, who is directly responsible for all aspects of the performance of methadone drug analysis and for the supervision of personnel who perform such analysis. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1164. Method. "Method" means the steps used by a trained person to determine the presence of drugs in urine or other body fluids. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1165. Instrument or Device. "Instrument" or "device" means any item or combination of items of equipment used to determine the presence of drugs; simple and complex devices are included in this meaning. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1166. Sample or Specimen. "Sample" or "specimen" means a representative portion of urine or other body fluid or of an artificially constituted material, taken for the purpose of determining the presence of drugs. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1167. Department. "Department" means the State Department of Health Services. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1168. May, Shall. "May" is permissive; "Shall" is mandatory. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1169. Methadone. "Methadone" means the substance that can be described as 6-dimethyl-amino-4, 4- diphenyl-3-heptanone. Methadone doses are usually administered as methadone chloride. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1170. Primary Metabolite of Methadone. "Primary Metabolite of Methadone" means: 2-ethylidene-1, 5-dimethyl-3, 3- diphenylpyrrolidine. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1171. Licensing Requirement. Every methadone drug analysis laboratory performing urine testing or other body fluid analysis for any methadone program operating in California shall have a valid license issued by the Department in accordance with these regulations. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11886 and 11887, Health and Safety Code. s 1172. Qualifications for Licensing. A methadone drug analysis laboratory meets the qualifications for licensing if it: (a) Employs at least one methadone drug analysis supervisor. (b) Furnishes the Department with detailed, written descriptions of each method it uses for drug analysis. Such description shall clearly describe the initial test and confirmatory test methods. (c) Maintains an internal quality control program. (d) Demonstrates satisfactory performance in an initial proficiency testing program conducted by the Department. (e) Demonstrates satisfactory performance in a continuing external proficiency testing program conducted by or approved by the Department. (f) Passes such on-site inspections as the Department may require. (g) Demonstrates an ability to meet the requirements of these regulations. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885, 11886 and 11890, Health and Safety Code. s 1173. Qualifications of Methadone Drug Analysis Supervisor. A methadone drug analysis supervisor shall have the following qualifications: (a) Possesses a baccalaureate or higher degree, or an equivalent in chemistry, biochemistry, or other appropriate discipline as determined by the Department. (b) Has two years practical experience in performing drug analysis on biological fluids or tissues, such experience to include experience in interpretation of chromatographic, spectrophotometric and immunochemical testing results. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1174. Use or Access of Patients. A methadone drug analysis laboratory shall not employ or utilize the services of a patient of any methadone program in, nor permit any such patient access to, any of its activities involving urinalysis or other body fluids testing for any methadone program. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1175. Qualifying for License. Upon receipt of a completed application and upon payment of the required fee, the Department shall submit such proficiency test samples and perform such examinations as are required for that laboratory to complete the qualifications. Upon the laboratory's successfully completing all the qualifications, the Department shall issue to the applicant laboratory a methadone drug analyses laboratory license. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885, 11886 and 11887, Health and Safety Code. s 1176. Renewal of Licenses. A license issued under these regulations shall be renewed annually as long as the activity requiring licensure continues. Renewal shall be contingent upon the laboratory continuing to fulfill the qualifications as set forth in these regulations, and is further subject to the following: (a) A methadone drug analysis laboratory license shall be valid from July 1 to June 30 of the next succeeding calendar year. Applications for renewal and all applicable fees shall be submitted to the Department on or before April 1 of each year. (b) Failure to apply for renewal shall result in forfeiture after a period of three months from the day on which the application for renewal should have been submitted, with the exception that the Department may grant a temporary extension under special circumstances. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11887, Health and Safety Code. s 1177. Application Forms. Application for a license and a renewal thereof, shall be made on forms furnished by the Department. The applicant shall set forth all pertinent information called for by the form. Application forms may be obtained from, and shall be sent to: Clinical Chemistry Laboratory, Department of Health Services, 2151 Berkeley Way, Berkeley, CA 94704. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11887, Health and Safety Code. s 1178. Report of Change or Discontinuance. The person responsible for the operation of a methadone drug analysis laboratory shall report to the Department in writing within 30 days any change in ownership, change in supervisorial personnel, changes in methods of analysis, change of address or discontinuance of an activity authorized under these regulations. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1179. License Implications. Licenses issued under these regulations shall not imply approval of anything carried out by a laboratory other than what is specified on the license. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885, 11886 and 11887, Health and Safety Code. s 1180. Display of Licenses. Licenses issued under these regulations shall be displayed on request to representatives of the Department. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885 and 11887, Health and Safety Code. s 1181. Fees. The annual application fee for a methadone drug analysis laboratory license or its renewal shall be $100.00. A laboratory operated by the state, a county, a city, a city and county, other public agency or a clinical laboratory licensed pursuant to subdivision (f) of Section 1300 of the Business and Professions Code shall be exempt from the fee. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11887, Health and Safety Code. s 1182. Urine. The only presently approved body fluid which may be tested for a methadone program is urine. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885 and 11886, Health and Safety Code. s 1183. General. Urine samples taken for methadone drug analysis shall be collected and handled in a manner subject to the approval of the Department. The identity and the integrity of the sample shall be maintained through col lection to analysis and reporting. The only approved urine sample shall be one which has been collected under direct observation by a staff member of the methadone program. The sample shall be deposited in a clean container. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1184. Sample Preservation. While not in transit to a laboratory, or being analyzed, any urine sample not containing a preservative shall be refrigerated. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1185. General. All methods used for methadone drug analysis shall be subject to the standards as set forth in these regulations. Each licensed methadone drug analysis laboratory shall have on file with the Department detailed, current written descriptions of each method it uses for drug screening. Such descriptions shall be immediately available to the person performing an analysis and shall be available for inspection by the Department on request. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1186. Standards of Performance. The methods of analysis used by a laboratory shall be able to detect the following drugs, and at least at the following concentrations, in urine: Methadone 2 micrograms per milliliter Primary Metabolite of Methadone 1 microgram per milliliter Morphine (total of free and conjugated) 1 microgram per milliliter Codeine 1 microgram per milliliter Amphetamine 2 micrograms per milliliter Methamphetamine 5 micrograms per milliliter Phenobarbital 1 microgram per milliliter Pentobarbital 1 microgram per milliliter Secobarbital 1 microgram per milliliter Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1187. Specificity. In order to insure adequate specificity, all positive findings, with the exception of methadone, shall be confirmed using an alternate method of analysis, fundamentally different from that used in the initial test. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1188. Evaluation of Standards of Performance. The ability of methods to meet the standards of performance, as contained in this Article, shall be subject to evaluation by the Department using either a laboratory's internal quality control or external proficiency testing results, or both. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1189. Expression of Analytical Results. All analytical results shall be expressed in terms of the generic or chemical name of any drug found to be present, and analytical results shall not be expressed in equivocal terms, such as "possible traces" or "plus-minus." Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1190. Inspections and Proficiency Testing. Licensed methadone drug analysis laboratories and laboratories applying for licensure shall be subject to on-site inspections by representatives of the Department, and shall cooperate in the quality control proficiency testing program conducted by or approved by the Department. These tests shall be used by the Department to evaluate the accuracy of the analyses performed by the laboratory. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11888 and 11890, Health and Safety Code. s 1191. Access to Premises. The Department may enter any methadone drug analysis laboratory at any reasonable time for the purpose of determining whether or not the laboratory is complying with the provisions of these regulations. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11888 and 11890, Health and Safety Code. s 1192. Quality Control Program and Proficiency Testing. Methods for methadone drug analysis shall be performed in accordance with the following quality control program: (a) Each laboratory shall have its own internal quality control program and shall analyze a suitable control sample with each set of 50 samples. (b) Each laboratory shall demonstrate acceptable performance in an external proficiency testing program. The Department shall submit blind proficiency test samples on a random basis to each methadone program director; at least 12 samples per quarter shall be submitted. The methadone program director shall, in turn, submit this sample to the methadone drug analysis laboratory in a container which is normally used by the program. Each container shall bear identifying numbers and letters that are indistinguishable from those used by patients in that program. The proficiency test samples shall arrive at the laboratory intermingled with other regular specimens. When the analysis is completed, the methadone program director shall forward the results of the analysis to the Department. The Department shall notify both the methadone program director and the director of the methadone drug analysis laboratory of the results of the proficiency test at the end of each month. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. s 1193. Standard of Performance in Proficiency Testing Program. Whenever a laboratory fails to correctly analyze at least 90 percent of the external proficiency test samples, the Department may take such action as it deems necessary or desirable to correct the source of error. Such action may include, but is not limited to, the removal of the laboratory from the List of Certified Methadone Laboratories, and, concurrently or separately, the commencement of disciplinary proceedings to suspend or revoke the license of the laboratory. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885, 11889 and 11893, Health and Safety Code. s 1194. List of Certified Methadone Laboratories. The Department shall compile, maintain and publish a current List of Certified Methadone Laboratories, which shall contain all licensed methadone drug analysis laboratories which are currently able to meet the acceptable level of performance required by the provisions of this subchapter. Whenever the Department determines that any licensed laboratory is presently unable to meet the acceptable level of performance, the Department shall remove the name of the laboratory from said list and notify all programs in the State of such removal. A laboratory so removed from the list shall not be restored to the list unless and until the laboratory demonstrates to the satisfaction of the Department that it is able to meet the acceptable level of performance. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11889, Health and Safety Code. s 1195. General. Methadone drug analysis laboratories shall maintain records which clearly describe their activities under these regulations. Such records shall be available for inspection by the Department upon request. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Sections 11885 and 11890, Health and Safety Code. s 1196. Methadone Drug Analysis Laboratory Records. Each licensed methadone drug analysis laboratory shall keep and preserve, for at least three years, the following records: (a) A record, which is kept current, of persons in its employ who are qualified as methadone drug analysis supervisors. This record shall include the qualifications of each such person, including education, experience, training and performance in examinations and tests conducted by the Department. (b) A detailed, current written description of each method it uses for drug screening. (c) Complete records of samples analyzed under these regulations, which shall include sample number, date sample received, date sample analyzed, results and date results sent to methadone program director. (d) Records of the internal quality control program. (e) Records of laboratory performance as shown by results in the external proficiency testing program. Note: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code. Reference: Section 11885, Health and Safety Code. Note: Authority cited: Sections 208 and 4025, Health and Safety Code. Reference Section 4025, Health and Safety Code. s 1200. Definitions. (a) As used in this group, "person" includes teaching institution, university, college, legally licensed hospital, nonprofit blood bank, artery bank, eye bank, or other therapeutic service operated by any agency approved by the State Director of Health Services. (b) As used in this group, "department" means State of California Department of Health. Note: Authority cited for Group 7: Sections 102 and 208, Health and Safety Code s 1201. Approval Required for Tissue Preservation. No person shall collect, process, store, or distribute human tissues obtained in accordance with Sections 7100 or 7115 of the Health and Safety Code, or Section 20 of the Probate Code, unless such person shall have received approval from the department. s 1202. Provisions for Approval. (a) An application for approval shall be made to the department, which shall include the following items. (1) Complete and detailed description of the methods, equipment, and technics used in relation to each tissue which is to be processed. (2) The name and address of the person owning the place, establishment, or institution, in which the processing is to be carried on. (3) The name and address of the director who shall be a duly licensed physician and surgeon in the State of California. (4) Kinds of tissues to be processed. (5) Such additional information as the department may require in order to determine compliance with these regulations. (b) The operation of the tissue bank shall be under the direct supervision of a physician and surgeon duly licensed in this State. (c) The person shall be prepared to begin operations at the time application for approval is submitted. (d) Application will be approved only when establishment and the methods used are such that the tissues processed will not be contaminated, dangerous, or harmful. (1) Representative samples shall be provided for the department of each lot of tissues, if requested by the department, for the purpose of checking sterility, quality, or other factor. (2) Any duly authorized representative of the department shall have free access to the establishment and the records thereof at all reasonable hours for the purpose of ascertaining compliance with these regulations. (e) Approval may be granted only for the processing of tissues for which there is scientific evidence of therapeutic value and for which methods of preservation have been developed. (f) Renewal of Approval. (1) The department shall issue renewal notices annually prior to the end of each calendar year. (2) Each person on applying for renewal shall review his activities in the field for the preceding year if requested to do so by the department. (g) There is no fee required in connection with this approval, or with renewal of approval. s 1203. Exemptions from Approval. This group does not apply to autogenous tissue grafting, or to homografts where tissues are obtained from living donors, or to other biologic products as defined in Section 1601 of the Health and Safety Code. s 1204. Records. (a) The director or supervisor of approved tissue processing programs shall keep records of all tissues processed. (b) Records may be designated by number (instead of by name of donor) to conform with individual specimens or lots of tissue. (c) Records shall contain the following data: (1) Name and address of institution from which material was obtained, also name of physician responsible for procurement. (2) Date and hour of death of donor. (3) Cause of death and age of donor and, when available, pathologic results including autopsy reports. (4) Date and hour of obtaining tissue. If more than four hours post mortem, state whether refrigeration was used and, if so, give length of time and temperature. (5) Date and method of processing tissue, if applicable. (6) Date final storage begins. (7) Date and place of use. (8) Results of tests for contamination and other examinations. (9) Pertinent laboratory data, including serologic tests for syphilis, from donor. Prospective donors with histories of hepatitis shall not be accepted. (10) Information relating to consent or authorization. (d) Unless otherwise required by other provisions of law, all records and information shall be retained for not less than two (2) years. s 1205. Labels. (a) A method which will positively identify each specimen during the period from procurement to the beginning of final storage shall be placed in effect by each person. (b) The final label shall show: (1) The name of the product, and method used in processing. (2) A number which will identify the processing information related to the specimen. (3) A date prior to which use must be made of the product, or prior to which use of the product is recommended, whichever is applicable. (4) Name and address of the processor. (5) If temperature is a factor in preservation, the temperature range within which deterioration is avoided shall be specified. (6) Other data descriptive of the product may also be included in the label. (7) Directions for reconstitution of the product, and preparation for its use may be included in the label or in an accompanying circular. (8) Altered or supplementary labels shall not be used. s 1215. Authority. Chapter 5 Sections 436.50-436.63 of Part 1 of Division 1 of the Health and Safety Code. Note: Authority cited: Sections 102 and 208, Health and Safety Code. s 1215.1. Definitions. (a) "Alcohol" means the unique chemical compound, ethyl alcohol, with the exception that reference in these regulations to compounds to be avoided as skin antiseptics includes the generic class of organic compounds known as alcohols. (b) "Forensic Alcohol Analysis" means the practical application of specialized devices, instruments, and methods by trained laboratory personnel to measure the concentration of ethyl alcohol in samples of blood, breath, urine, or tissue of persons involved in traffic accidents or traffic violations. (c) "Breath Alcohol Analysis" means analysis of a sample of a person's expired breath, using a breath testing instrument designed for this purpose, in order to determine the concentration of ethyl alcohol in the person's blood. (d) "Concentration" means the weight amount of alcohol contained in a unit volume of liquid or a unit volume of gas under specified conditions of temperature and pressure; in the case of a solid tissue specimen, "concentration" means the weight amount of alcohol contained in a unit weight of specimen. (e) "Forensic Alcohol Laboratory" means a place at which specialized apparatus, instruments, and methods are used by trained laboratory personnel to measure the concentration of alcohol in samples of blood, breath, urine, or tissue of persons involved in traffic accidents or in traffic violations; this may be an activity of a laboratory engaged in activities other than alcohol analysis. (f) "Forensic Alcohol Supervisor" means a person employed by a forensic alcohol laboratory who can be responsible for all aspects of the performance of forensic alcohol analysis and for the supervision of personnel who perform such analysis. (g) "Forensic Alcohol Analyst" means a person employed by a forensic alcohol laboratory who performs the technical procedures of forensic alcohol analysis. (h) "Forensic Alcohol Analyst Trainee" means a person employed by a forensic alcohol laboratory for the purpose of receiving comprehensive practical experience and instruction in the technical procedures of forensic alcohol analysis under the supervision of a forensic alcohol supervisor or forensic alcohol analyst. (i) "Method" means the steps used by a trained person to make a measurement of alcohol concentration. (j) "Instrument" or "Device" means any item or combination of items of equipment used to make a measurement of alcohol concentration; simple and complex devices are included in this meaning. (k) "License" means a document issued by the State Department of Health to a laboratory to perform the tests referred to in the Health and Safety Code, Sections 436.51 and 436.52. (l) "Sample" or "Specimen" means a representative portion of breath, blood, urine, or tissue or of an artificially constituted material, taken for the purpose of measuring its alcohol concentration. (m) "Alveolar" refers to the smallest air sacs in the lungs and to that portion of the expired breath which is in equilibrium with respect to alcohol with the immediately adjacent pulmonary blood. (n) "Department" means the California State Department of Health and its duly authorized representatives. s 1216. Authorization Requirement. (a) Every laboratory performing forensic alcohol analysis shall have a valid license issued in accordance with the provisions of these regulations. (1) Forensic alcohol analysis shall be performed only by persons who meet the qualifications set forth in these regulations for forensic alcohol supervisors, forensic alcohol analysts, or forensic alcohol analyst trainees. (A) A trainee may perform forensic alcohol analysis only under the supervision of a forensic alcohol supervisor or forensic alcohol analyst. (2) The Department shall not be limited by these regulations in performing functions in administration of the alcohol analysis and licensing program. s 1216.1. Qualifications for Licensing. (a) A laboratory meets the qualifications for licensing by: (1) Employing at least one forensic alcohol supervisor. If forensic alcohol analysis is performed by persons other than forensic alcohol supervisors, such persons shall meet the qualifications set forth in these regulations for forensic alcohol analysts or forensic alcohol analyst trainees; (2) Maintaining a quality control program in forensic alcohol analysis procedures; (3) Demonstrating satisfactory performance in a proficiency testing program conducted by or approved by the Department; (4) Passing such on-site inspections as the Department may require; (5) Showing ability to meet the requirements set forth in these regulations. (b) These qualifications shall be maintained at all times by each licensed laboratory. (c) The Department may deny a license or renewal thereof, or take disciplinary action against a licensee, for failure to maintain these qualifications in a manner which meets the Department's standards for approval. (d) Whenever a licensed laboratory employing only one forensic alcohol supervisor loses that person, the Department may upon petition of the laboratory extend the license for a period not exceeding 90 days during which time the laboratory shall hire another forensic alcohol supervisor. (1) Such an extension shall be contingent on the laboratory's having in its employ at least one forensic alcohol analyst and upon the laboratory's successfully demonstrating to the Department continued competence in forensic alcohol analysis through such proficiency tests, examinations, and on-site inspections as the Department may require. (e) A forensic alcohol supervisor is a person who meets the following qualifications: (1) Possesses a baccalaureate or higher degree, or an equivalent, in chemistry, biochemistry, or other appropriate discipline as determined by the Department; (2) Has two years of experience in performing forensic alcohol analysis, such experience to include experience in interpretation and correlation of alcohol analyses with subjective observations of the demeanor and behavior of persons who have ingested known amounts of ethyl alcohol; or, in lieu of such two years of experience, satisfactorily completes a training course approved by the Department, such training course to include at minimum the following schedule of subjects: (A) Value and purpose of forensic alcohol analysis, including breath alcohol analysis; (B) Physiological action of alcohol; (C) Pharmacology and toxicology of alcohol; (D) Laboratory methods of alcohol analysis; (E) Instruments and procedures for breath alcohol analysis; (F) Practical laboratory demonstration of the student's ability to perform alcohol analysis; (G) Interpretation of results of alcohol analysis, including correlation of alcohol analyses with subjective observations of the demeanor and behavior of persons who have ingested known amounts of alcohol; (H) Court testimony; (I) Court decisions regarding chemical tests of alcohol to determine alcohol influence; and (J) Requirements of these regulations; (3) Successfully demonstrates accuracy in the analysis of proficiency test samples submitted by the Department, and successfully passes examinations prescribed by the Department; (4) Demonstrates the ability to adhere to the provisions of these regulations; or (in lieu of (1) and (2) above) (5) Either is a person who, prior to January 1, 1971, qualified as director of a clinical laboratory operating under the provisions of the California Business and Professions Code, or is a person who, for a period of one year prior to January 1, 1971, has been employed in the activities of a forensic alcohol supervisor. (f) A forensic alcohol analyst is a person who meets the following qualifications: (1) Successfully completes at least 60 semester-hours, or their equivalent in quarter-hours, of college level courses, including 8 hours of general chemistry and 3 hours of quantitative analysis; (2) Successfully completes a training period in alcohol analysis on forensic or clinical specimens in a forensic alcohol laboratory or in a clinical laboratory; (3) Performs during the training period a minimum of 25 analyses of alcohol concentration in blood samples, at least half of which contain alcohol; (4) Successfully demonstrates accuracy in the analysis of proficiency test samples submitted by the Department, and successfully passes examinations prescribed by the Department; (5) Demonstrates ability to adhere to the provisions of these regulations; or (in lieu of (1), (2), and (3) above) (6) Either is a person who, prior to January 1, 1971, was a clinical laboratory technologist licensed under the provisions of the California Business and Professions Code, or is a person who, for a period of one year prior to January 1, 1971, has been employed in the activities of a forensic alcohol analyst. (g) A forensic alcohol analyst trainee is a person who meets the following qualifications: (1) Meets the educational qualification set forth as (1) for a forensic alcohol analyst; (2) Is employed by a licensed forensic alcohol laboratory. s 1217. Forensic Alcohol Laboratory License. (a) Upon receipt of a completed application which shows ability to meet the requirements set forth in these regulations, and upon payment of any required fee, the Department shall submit such proficiency test samples and perform such examinations as are required for that laboratory to complete the qualifications. (b) Upon the laboratory's successfully completing all the qualifications, the Department shall issue to the applicant laboratory a forensic alcohol laboratory license. s 1217.1. Renewal of Licenses. (a) Licenses under these regulations shall be renewed as required by the Department as long as the activity requiring authorization continues. Renewal shall be contingent upon the laboratory continuing in the qualifications set forth in these regulations. (1) A forensic alcohol laboratory license shall be valid from January 1 to December 31 of a calendar year. Applications for renewal and applicable fees shall be submitted to the Department on or before October 1 of each year. (2) Failure to apply for renewal shall result in forfeiture after a period of three months from the day on which the application for renewal should have been submitted, with the exception that the Department may grant a temporary extension under special circumstances. (3) An application for renewal shall not list as a forensic alcohol analyst trainee any person who fails to comply with the requirements of Section 1216.1 (f) (4) within a period of one year after he was first listed with the Department as a trainee. The Department may extend this period for a justifiable reason, such as illness. s 1217.2. Application Forms. Application for a license and renewal thereof, shall be made on forms furnished by the Department. The applicant shall set forth all pertinent information called for by the form. s 1217.3. Report of Change or Discontinuance. (a) A person responsible for the operation of a forensic alcohol laboratory shall report to the Department in writing within 30 days any change in qualified personnel who may be performing forensic alcohol analysis, change of ownership, change of address or change or discontinuance of an activity authorized under these regulations. (b) Such reports shall be made on forms furnished by the Department and shall set forth all pertinent information called for by the form. (c) Persons who formerly qualified as forensic alcohol supervisors or forensic alcohol analysts in another laboratory may be required to demonstrate again their ability to meet the requirement of Section 1216.1 (e) (3) or 1216.1 (f) (4) using the method, apparatus and facilities of the forensic alcohol laboratory which newly lists them in such a Report of Change or Discontinuance. s 1217.4. License Implications. Licenses issued under these regulations shall not imply approval of anything carried out by a laboratory other than what is specified on the document. s 1217.5. Licensing Records. Forensic Alcohol Laboratory Licenses shall become part of permanent records available to the courts for legal proceedings or to the Department. s 1217.6. Inspection and Additional Requirements. (a) Display of Licenses. Licenses issued under these regulations shall be displayed on request to representatives of the Department. (b) Access to Premises. The Department may enter at all reasonable times upon any laboratory for the purpose of determining whether or not there is compliance with the provisions of these regulations. s 1217.7. Surveys and Proficiency Tests. (a) Laboratories having been licensed or applying for licensing as forensic alcohol laboratories shall be subject to on-site surveys by representatives of the Department, the results of which must meet the requirements of these regulations, and shall accept periodic evaluation samples, perform analyses and report the results of such analyses to the Department. (b) These analytical results shall be used by the Department to evaluate the accuracy of the forensic alcohol analyses performed by the laboratory, and the results must meet the requirements of these regulations. s 1217.8. Fees and Other Procedures. The annual application fee for a Forensic Alcohol Laboratory License or its renewal shall be one hundred dollars ($100). A laboratory operated by the state, city or county or other public organization shall be exempt from the annual application fee requirement. Other procedures in the administration of these regulations shall be carried out as set forth in Chapter 5 (commencing with section 436.50) of Part 1 of Division 1 of the Health and Safety Code. Such other procedures include suspension or revocation of license, denial of license, and disciplinary action. s 1218. Training Program Approval. Any organization, laboratory, institution, school, or college conducting a course of instruction for persons to qualify under these regulations shall submit a course summary and list of instructors and their qualifications to the Department for approval. s 1218.1. Additional Requirements. At the discretion of the Department, any phase or portion of a training program shall be subject to alteration in an effort to update the program as technological advances are made or if a portion has been judged inappropriate. s 1218.2. Contracts. The Department may contract with persons it deems qualified to administer such practical tests and written or oral examinations as may be required under these regulations. This section shall not be construed to authorize the delegation of any discretionary functions conferred on the Department by law, including, but not limited to, the evaluation of tests and examinations. s 1219. General. Samples taken for forensic alcohol analysis and breath alcohol analysis shall be collected and handled in a manner approved by the Department. The identity and integrity of the samples shall be maintained through collection to analysis and reporting. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 436.50, Health and Safety Code. s 1219.1. Blood Collection and Retention. (a) Blood samples shall be collected by venipuncture from living individuals as soon as feasible after an alleged offense and only by persons authorized by Section 13354 of the Vehicle Code. (b) Sufficient blood shall be collected to permit duplicate determinations. (c) Alcohol or other volatile organic disinfectant shall not be used to clean the skin where a specimen is to be collected. Aqueous benzalkonium chloride (zephiran), aqueous merthiolate or other suitable aqueous disinfectant shall be used. (d) Blood samples shall be collected using sterile, dry hypodermic needles and syringes, or using clean, dry vacuum type containers with sterile needles. Reusable equipment,if used, shall not be cleaned or kept in alcohol or other volatile organic solvent. (e) The blood sample shall be deposited into a clean, dry container which is closed with an inert stopper. (1) Alcohol or other volatile organic solvent shall not be used to clean the container. (2) The blood shall be mixed with an anticoagulant and a preservative. (f) When blood samples for forensic alcohol analysis are collected post-mortem, all practical precautions to insure an uncontaminated sample shall be employed, such as: (1) Samples shall be obtained prior to the start of any embalming procedure. Blood samples shall not be collected from the circulatory system effluent during arterial injection of embalming fluid. Coroner's samples do not need a preservative added if stored under refrigeration. (2) Care shall be taken to avoid contamination by alcohol from the gastrointestinal tract directly or by diffusion therefrom. The sample shall be taken from a major vein or the heart. (g) In order to allow for analysis by the defendant, the remaining portion of the sample shall be retained for one year after the date of collection. (1) In coroner's cases, blood samples shall be retained for at least 90 days after date of collection. (2)Whenever a sample is requested by the defendant for analysis and a sufficient sample remains, the forensic alcohol laboratory or law enforcement agency in possession of the original sample shall continue such possession, but shall provide the defendant with a portion of the remaining sample in a clean container together with a copy or transcript of the identifying information carried on the original sample container. s 1219.2. Urine Collection and Retention. (a) The only approved urine sample shall be a sample collected no sooner than twenty minutes after first voiding the bladder. (b) The specimen shall be deposited in a clean, dry container which also contains a preservative. (c) In order to allow for analysis by the defendant, the remaining portion of the sample shall be retained for one year after the date of collection. (1) Whenever a sample is requested by the defendant for analysis and a sufficient sample remains, the forensic alcohol laboratory or law enforcement agency in possession of the original sample shall continue such possession, but shall provide the defendant with a portion of the remaining sample in a clean container together with a copy or transcript of the identifying information carried by the original sample container. s 1219.3. Breath Collection. A breath sample shall be expired breath which is essentially alveolar in composition. The quantity of the breath sample shall be established by direct volumetric measurement. The breath sample shall be collected only after the subject has been under continuous observation for at least fifteen minutes prior to collection of the breath sample, during which time the subject must not have ingested alcoholic beverages or other fluids, regurgitated, vomited, eaten, or smoked. s 1220. General. (a) All laboratory methods used for forensic alcohol analysis shall be subject to standards set forth in this Article. (b) Each licensed forensic alcohol laboratory shall have on file with the Department detailed, up-to-date written descriptions of each method it uses for forensic alcohol analysis. (1) Such descriptions shall be immediately available to the person performing an analysis and shall be available for inspection by the Department on request. (2) Each such description shall include the calibration procedures and the quality control program for the method. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 436.50, Health and Safety Code. s 1220.1. Standards of Performance. (a) Methods for forensic alcohol analysis shall meet the following standards of performance: (1) The method shall be capable of the analysis of a reference sample of known alcohol concentration within accuracy and precision limits of plus or minus 5 percent of the value; these limits shall be applied to alcohol concentrations which are 0.10 grams per 100 milliliters or higher; (2) The method shall be capable of the analysis of ethyl alcohol with a specificity which is adequate and appropriate for traffic law enforcement. (3) The method should be free from interference from anticoagulants and preservatives added to the sample; (4) Blood alcohol results on post-mortem samples shall not be reported unless the oxidizable substance is identified as ethyl alcohol by qualitative test; (5) The method shall give a test result which is always less than 0.01 grams of alcohol per 100 milliliters of blood when living subjects free of alcohol are tested. (b) The ability of methods to meet the standards of performance set forth in this Section shall be evaluated by the Department using a laboratory's proficiency test results and such ability must meet the requirements of these regulations. s 1220.2. Standards of Procedure. (a) Methods for forensic alcohol analysis shall meet the following standards of procedure: (1) The method shall be calibrated with standards which are water solutions of alcohol. (A) Such alcohol solutions are secondary standards. (B) Each forensic alcohol laboratory shall establish the concentration of each lot of secondary alcohol standards it uses, whether prepared or acquired, by an oxidimetric method which employs a primary standard, such as United States National Bureau of Standards potassium dichromate; (2) The procedure shall include blank and secondary alcohol standard samples at least once each day that samples are subjected to forensic alcohol analysis. (A) The blank and secondary alcohol standard samples shall be taken through all steps of the method used for forensic alcohol analysis of samples. (3) The procedure shall also include analysis of quality control reference samples as described in Section 1220.3 and shall include at least duplicate analyses of samples for forensic alcohol analysis. (A) A quality control reference sample shall not be taken from the same lot of alcohol solution which is used as a secondary alcohol standard. (4) Alcohols or other volatile organic solvents shall not be used to wash or rinse glassware and instruments used for alcohol analysis; (5) All instruments used for alcohol analysis shall be in good working order and routinely checked for accuracy and precision. s 1220.3. Quality Control Program. (a) Methods for forensic alcohol analysis shall be performed in accordance with the following quality control program: (1) For each method of forensic alcohol analysis it performs, each forensic alcohol laboratory shall make or acquire a suitable quality control reference material containing alcohol, a sample of which it shall analyze along with each set of samples; the alcohol concentration in the reference material shall be between 0.10 and 0.20 grams per 100 milliliters of liquid; (2) For each lot of quality control reference material, the laboratory shall determine a mean value of at least 20 replicate analyses, at a rate of no more than 2 analyses per day, with the method used for analysis of samples for forensic alcohol analysis; (3) Acceptable limits of variation for the method shall be set as follows: (A) The lower limit shall be calculated by subtracting, from the mean value, 0.01 grams per 100 milliliters; (B) The higher limit shall be calculated by adding, to the mean value, 0.01 grams per 100 milliliters; (4) At least one sample of the quality control reference material shall be analyzed with each set of samples analyzed for the purpose of forensic alcohol analysis; (5) Whenever analysis of the quality control reference material is outside the acceptable limits, the method shall be regarded to be in error, and a forensic alcohol supervisor shall take remedial action to investigate and correct the source of error; (6) Until such time as the error has been corrected, as shown by return of the analysis of the quality control reference material to values within the acceptable limits, no samples shall be analyzed for the purpose of forensic alcohol analysis. s 1220.4. Expression of Analytical Results. (a) With the exception of tissue analysis, all analytical results shall be expressed in terms of the alcohol concentration in blood, based on the number of grams of alcohol per 100 milliliters of blood. (1) The symbols, grams %, %, and % (W/V), shall be regarded as acceptable abbreviations of the phrase, grams per 100 milliliters of liquid. (b) Analytical results shall be reported to the second decimal place, deleting the digit in the third decimal place when it is present. (c) Blood alcohol concentrations less than 0.01% in living subjects may be reported as negative. (d) Blood alcohol concentrations less than 0.02% on post-mortem blood samples may be reported as negative. (e) A urine alcohol concentration shall be converted to an equivalent blood alcohol concentration by a calculation based on the relationship: the amount of alcohol in 1.3 milliliters of blood is equivalent to the amount of alcohol in 1 milliliter of urine. (f) A breath alcohol concentration shall be converted to an equivalent blood alcohol concentration by a calculation based on the relationship: the amount of alcohol in 2,100 milliliters of alveolar breath is equivalent to the amount of alcohol in 1 milliliter of blood. (g) Tissue analysis results shall be expressed in terms of a weight amount of alcohol in a unit weight of the specimen. s 1221. General. Breath alcohol analysis shall be performed in accordance with standards set forth in this Article. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 436.50, Health and Safety Code. s 1221.1. Authorized Procedures. (a) Breath alcohol analysis shall be performed only with instruments and related accessories which meet the standards of performance set forth in these regulations. (b) Such instruments may be used for the analysis of breath samples in places other than licensed forensic alcohol laboratories and by persons other than forensic alcohol supervisors, forensic alcohol analysts and forensic alcohol analyst trainees only if such places and persons are under the direct jurisdiction of a governmental agency or licensed forensic alcohol laboratory. (1) Breath alcohol analysis by persons other than forensic alcohol supervisors, forensic alcohol analysts and forensic alcohol analyst trainees shall be restricted to the immediate analysis of breath samples collected by direct expiration by the subject into the instrument in which the measurement of alcohol concentration is performed. (2) Except for the requirements of Section 1220.4, such immediate analysis shall not be subject to the requirements of Article 6. Note: Authority cited: Sections 208 and 436.50, Health and Safety Code. Reference: Section 436.52, Health and Safety Code. s 1221.2. Standard of Performance. (a) Instruments for breath alcohol analysis shall meet the following standard: (1) The instrument and any related accessories shall be capable of conforming to the "Model Specifications for Evidential Breath Testing Devices" of the National Highway Traffic Safety Administration of the U.S. Department of Transportation, which were published in the Federal Register, Vol. 49, No. 242, Pages 48854-48872, December 14, 1984, and are hereby adopted and incorporated. (b) The ability of instruments and any related accessories to conform to the standard of performance set forth in this section shall be tested by the U.S. Department of Transportation. Note: Authority cited: Sections 208 and 436.50, Health and Safety Code. Reference: Section 436.52, Health and Safety Code. s 1221.3. Approved Instruments. (a) Only such types and models of instruments and related accessories as are named in the "Conforming Products List" published in the Federal Register by the National Highway Traffic and Safety Administration of the U.S. Department of Transportation shall be used for breath alcohol analysis in this State. Note: Authority cited: Sections 208 and 436.50, Health and Safety Code. Reference: Section 436.52, Health and Safety Code. s 1221.4. Standards of Procedure. (a) Procedures for breath alcohol analysis shall meet the following standards: (1) For each person tested, breath alcohol analysis shall include analysis of 2 separate breath samples which result in determinations of blood alcohol concentrations which do not differ from each other by more than 0.02 grams per 100 milliliters. (2) The accuracy of instruments shall be determined. (A) Such determination of accuracy shall consist, at a minimum, of periodic analysis of a reference sample of known alcohol concentration within accuracy and precision limits of plus or minus 0.01 grams % of the true value; these limits shall be applied to alcohol concentrations from 0.10 to 0.30 grams %. The reference sample shall be provided by a forensic alcohol laboratory. 1. Such analysis shall be performed by an operator as defined in Section 1221.4 (a)(5), and the results shall be used by a forensic alcohol laboratory to determine if the instrument continues to meet the accuracy set forth in Section 1221.4 (a)(2)(A). (B) For the purposes of such determinations of accuracy, "periodic" means either a period of time not exceeding 10 days or following the testing of every 150 subjects, whichever comes sooner. (3) Breath alcohol analysis shall be performed only with instruments for which the operators have received training, such training to include at minimum the following schedule of subjects: (A) Theory of operation; (B) Detailed procedure of operation; (C) Practical experience; (D) Precautionary checklist; (E) Written and/or practical examination. (4) Training in the procedures of breath alcohol analysis shall be under the supervision of persons who qualify as forensic alcohol supervisors, forensic alcohol analysts or forensic alcohol analyst trainees in a licensed forensic alcohol laboratory. (A) After approval as set forth in Section 1218, the forensic alcohol laboratory is responsible for the training and qualifying of its instructors. (5) An operator shall be a forensic alcohol supervisor, forensic alcohol analyst, forensic alcohol analyst trainee or a person who has completed successfully the training described under Section 1221.4 (a) (3) and who may be called upon to operate a breath testing instrument in the performance of his duties. (6) Records shall be kept for each instrument to show the frequency of determination of accuracy and the identity of the person performing the determination of accuracy. (A) Records shall be kept for each instrument at a licensed forensic alcohol laboratory showing compliance with this Section. Note: Authority cited: Section 436.50, Health and Safety Code. Reference: Section 436.50, Health and Safety Code. s 1221.5. Expression of Analytical Results. Results of breath alcohol analysis shall be expressed as set forth in Section 1220.4. s 1222. General. Forensic alcohol laboratories and law enforcement agencies shall maintain records which clearly represent their activities which are covered by these regulations. Such records shall be available for inspection by the Department on request. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 436.50, Health and Safety Code. s 1222.1. Forensic Alcohol Laboratory Records. (a) Each laboratory which is licensed to perform forensic alcohol analysis shall keep the following records for a period of at least three years: (1) An up-to-date record of persons in its employ who are qualified as forensic alcohol supervisors and forensic alcohol analysts; the record shall include the qualifications of each such person, including education, experience, training and performance in proficiency tests and examinations; (2) A list of persons in its employ who are forensic alcohol analyst trainees, the date on which each such person began his training period and the number and results of analyses performed during the training period; (3) Records of samples analyzed by that laboratory under these regulations, their results and the identity of persons performing the analyses; (4) Records of the quality control program; (5) Records of laboratory performance evaluation in alcohol analysis as shown by results of proficiency tests; (6) Records of such determinations of accuracy of breath testing instruments as a laboratory may perform for law enforcement agencies; (7) Records of such training as a laboratory may provide to persons who operate breath testing instruments for law enforcement agencies. s 1222.2. Breath Alcohol Analysis Records. (a) Each agency shall keep the following records for breath testing instruments which are under its jurisdiction: (1) Records of instrument determinations of accuracy; (2) Records of analyses performed, results and identities of the persons performing analyses; (3) At the location of each instrument, the precautionary checklist to be used by operators of the instrument. s 1230. Approval of Laboratories for Use of HIV Antibody Test. (a) A laboratory may be approved to perform tests to detect antibodies to HIV if the facility is licensed or certified as: (1) A facility is licensed to engage in the production of biologics in accordance with chapter 4, division 2 of the Health and Safety Code, or (2) A facility licenses as a clinical laboratory in accordance with chapter 3, division 2 of the Business and Professions Code, or (3) A facility certified as a public health laboratory in accordance with chapter 7, part 2, division 1 of the Health and Safety Code. (b) Out-of-state facilities shall be deemed to have met California's approval requirements for HIV antibody testing if licensed as either. (1) A blood bank by the United States Food and Drug Administration in accordance with 42 U.S.C., section 262(a), or (2) A clinical laboratory licensed in serology to engage in interstate commerce in accordance with the Clinical Laboratory Improvement Act of 1967 (CLIA-67), 42 U.S.C. section 263a. (c) An application for approval shall be submitted for each separate location where tests are performed using forms provided by the Department and providing information as required by the Department. Within 15 days of receipt of an application, the Department shall notify the applicant in writing that the application is complete or shall specifically identify what additional information is required. Within 60 days from the receipt of a completed application, the Department shaqll notify the applicant that his/her application is either approved or disapproved. (d) An approved laboratory shall perform screening for evidence of human immunodeficiency virus antibody (HIV) infection utilizing only Food and Drug Administration (USFDA) approved kits in the ELISA format. (e) Approved laboratories shall perform confirmatory testing on all specimens with a positive HIV screening result using FDA-approved Western blot kits or the immunofluoresence method developed and used by the Department of Health Services and other public health laboratories. (f) If a Western blot kit is used for confirmatory testing, the criteria for interpretation shall be those specified by the Department of Health Services. Currently, these criteria are those developed by the Association of State andTerritorial Laboratory Directors and the Centers for Disease Control (CDC) as published by CDC in the Morbidity and Mortality Weekly Report in the issue of 21 July 1989. (g) Whenever a confirmatory test gives an indeterminate result, the specimen giving such an indeterminate result shall be referred to a public health laboratory for further evaluation. If, upon further evaluation by the public health laboratory, the specimen gives an inconclusive result, the public health laboratory shall notify the referring laboratory of such inconclusiveness and the referring laboratory shall notify the subject of the test that another specimen must be obtained. (h) An approved laboratory shall maintain records of tests and test results in a manner to ensure the patient's confidentiality. (i) Approved laboratories which are blood banks or plasma centers shall report to the Department at the conclusion of each month and all other approved laboratories shall report to the Department at the conclusion of each quarter the number and results of the tests performed. (j) Approval for performing the tests to detect antibodies to HIV may be denied or terminated for failure to comply with the requirements of this section or with requirements set forth in law, or for conduct inimical to the public health, morals, welfare, or safety of the people of the State of California in the maintenance and operation of the facility or services for which approval is granted. Note: Authority cited: Sections 208 and 1603.1(h), Health and Safety Code. Reference: Section 5, Statutes of 1985, Chapter 23; and Sections 1603.1 and 1632, Health and Safety Code. <<(Subchapter Originally Printed 11-1-47)>> s 1250. Health Officer. The health department shall be under the direction of the health officer devoting full time to official duties and these duties shall constitute his primary responsibility and no other activities shall interfere with performance of his official duties. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 454 and 1130, Health and Safety Code. s 1251. Office. The health department shall maintain and operate a central office and headquarters on a full-time basis during the normal work week of the local government. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code. s 1252. Clerical Staff. There shall be a clerical staff under proper supervision, adequate to meet local needs. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code. s 1253. Public Health Nursing Staff. (a) There shall be a public health nursing staff under the supervision of a director of public health nursing, and such additional supervisors, who are necessary to provide effective service. Public health nurses shall be qualified and knowledgeable in matters pertaining to health, safety and sanitation within a local health jurisdiction which shall include but not be limited to: (1) The control and prevention of communicable and chronic disease; (2) The promotion of maternal, child and adolescent health; (3) The prevention of abuse and neglect of children, spouses and elderly adults within the home environment; (4) The case management of California Children Services or handicapped children; (5) The assessment and prevention of accidents within the home environment; (6) The provision of services for populations at risk; and, (b) All members of the public health nursing staff who are employed as public health nurses including supervisory personnel shall be certified. Note: Authority cited: Section 1130, Health and Safety Code. Reference: Sections 600-603, Health and Safety Code. s 1254. Environmental Health Staff. There shall be an adequate staff of Registered Sanitarians under the direction of a Director of Environmental Health. In addition, the staff shall include such other support personnel as are required to carry out the environmental health program. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1111 and 1130, Health and Safety Code. s 1255. Public Health Laboratory. The principal public health laboratory shall be under the direction of a public health laboratory director. A branch public health laboratory shall be under the direction of a branch public health laboratory director who shall be directly responsible to the director of the principal public health laboratory. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1000, 1001, 1002, 1111 and 1130, Health and Safety Code. s 1256. Provisional Approval of Health Departments. The Director of Health Services, after thorough investigation of geographic, transportation, economic, or other conditions, may grant provisional approval to health departments which serve all of the incorporated, as well as the unincorporated, area of the county and which are under the direction of a part-time county health officer; provided, however, that such counties shall have a population of less than 25,000, as determined pursuant to Section 1101, Chapter 8, Part 2, Division 1 of the Health and Safety Code. Such health departments, however, shall meet all standards established for local health departments by the Department except Section 1250 of this article. Such provisional approval shall terminate on June 30, 1948, but may be renewed annually at the discretion of the Director. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1101, 1102 and 1130, Health and Safety Code. s 1275. Duties and Functions. A local health department, in order to qualify for funds pursuant to Division 1, Part 2, Chapter 8, of the Health and Safety Code, shall perform all of the duties and functions imposed upon it by the Health and Safety Code and other statutes of the State of California, and by the rules, regulations and orders of the Department of Health Services. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1130 and 1155, Health and Safety Code. s 1276. Basic Services. The health department shall offer at least the following basic services to the health jurisdiction which it serves: (a) Collection, tabulation and analysis of all public health statistics, including population data, natality, mortality and morbidity records, as well as evaluation of service records. (b) Health education programs including, but not necessarily limited to, staff education, consultation, community organization, public information, and individual and group teaching, such programs to be planned and coordinated within the department and with schools, public and voluntary agencies, professional societies, and civic groups and individuals. (c) Communicable disease control, including availability of adequate isolation facilities, the control of the acute communicable diseases, and the control of tuberculosis and the venereal diseases, based on provision of diagnostic consultative services, epidemiologic investigation and appropriate preventive measures for the particular communicable disease hazards in the community. (d) Medical, nursing, educational, and other services to promote maternal and child health, planned to provide a comprehensive program to meet community needs in these fields. (e) Environmental health and sanitation services and programs in accordance with an annual plan and program outline as required in Title 17, Section 1328, and approved by the State Department of Health and the applicable services and program standards as specified in the State Department of Health "Services in a Local Environmental Health and Sanitation Program," September 1976. The required services and programs shall be as follows: (1) Food. (2) Housing and institutions. (3) Radiological health in local jurisdictions contracting with the State Department of Health to enforce the Radiation Control Law pursuant to Section 25600-25654 and Sections 25800-25876, Health and Safety Code. (4) Milk and dairy products in local jurisdictions maintaining an approved milk inspection service pursuant to Section 32503, Food and Agricultural Code. (5) Water oriented recreation. (6) Safety. (7) Vector control. (8) Wastes management. (9) Water supply. (10) Air sanitation. (11) Additional environmentally related services and programs as required by the County Board of Supervisors, City Council, or Health District Board. (12) And may include land development and use. (f) Laboratory services, provided by an approved public health laboratory in health departments serving a population of 50,000 or more. Such laboratories shall provide: (1) Services necessary for the various programs of the health department. (2) Consultation and reference services to further the development of improved procedures and practices in laboratories employing such procedures related to the prevention and control of human disease. (g) Services in nutrition, including appropriate activities in education and consultation for the promotion of positive health, the prevention of ill health, and the dietary control of disease. (h) Services in chronic disease, which may include case finding, community education, consultation, or rehabilitation, for the prevention or mitigation of any chronic disease. (i) Services directed to the social factors affecting health, and which may include community planning, counseling, consultation, education, and special studies. (j) Services in occupational health to promote the health of employed persons and a healthful work environment, including educational, consultative and other activities appropriate to local needs. Where the population of a health jurisdiction exceeds 500 thousand, the program in occupational health shall include a planned and organized service with trained staff. (1) "Services in occupational health" shall mean, as a minimum, a program of industrial sanitation and surveillance of occupational health hazards to insure that places of employment are maintained in a healthful and sanitary condition. For the purpose of this section, "sanitary condition" is defined as equivalent to that described in the "Recommended Standards of Sanitation in Places of Employment" issued by the California State Department of Health Services. Such services shall be provided by at least one Occupational Health Sanitarian as defined in Section 1307, or any one of the occupational health disciplines in Section 1306, with medical, sanitation, and public health nursing support available. (2) "Planned and organized service" shall include services in occupational health as defined above, and in addition the prevention of work-induced illness and disability by recognizing, evaluating and preventing unhealthful environmental conditions and practices in places of work. (3) "Trained staff" shall be defined as follows: (A) When the health jurisdiction includes a population of 500,000 to 1,000,000, at least 1, and after July 1, 1968, 2 full-time health professionals representing 1 or 2, respectively, of the disciplines listed in part (4) hereof shall be employed. (B) When health jurisdictions include more than 1,000,000 population at least 2, and after July 1, 1968, 3 full-time health professionals representing 2 or 3, respectively, of the 5 disciplines listed in part (4) hereof shall be employed. (C) When health jurisdictions include more than 5,000,000 population, at least 10 full-time health professionals including all 5 of the disciplines listed in part (4) hereof shall be employed. (4) Occupational health disciplines include: Occupational Health Physician; Occupational Health Nursing Consultant; Industrial Hygiene Engineer; Industrial Hygienist (including sanitarians with appropriate training); and Industrial Hygiene Chemist as defined in Section 1306. (k) Appropriate services in the field of family planning, which may include: (1) Promotion of availability of program elements such as: (A) Assembling knowledge about family planning, attitudes, values, and information held by population groups. (B) Public and professional educational services about the health benefits of family planning and fertility control methods. (C) Professional services for sterility correction,fertility control and genetic counseling for all segments of the population, making available methods acceptable to families of any religious persuasion. (D) Evaluation of the adequacy of the community's family planning efforts. (2) Provision of program elements which are not otherwise likely to be made available, including family planning services for those groups who cannot reasonably obtain them. (l) Public health nursing services to provide for the preventive and therapeutic care of the population served. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1111, 1112, 1113, 1130, 1155, 1555.5 and 1155.6, Health and Safety Code. s 1300. Health Officer. The health officer shall be a graduate of a medical school of good standing and repute and shall be eligible for a license to practice medicine and surgery in the State of California; provided however that those health officers on a full-time basis as of September 19, 1947, shall be considered as meeting the requirements of this section. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 454 and 1130, Health and Safety Code. s 1301. Director of Public Health Nursing. (a) A director of public health nursing shall be a public health nurse who has: (1) Completed a baccalaureate program of study in public health nursing accredited by the National League for Nursing and has had three years of progressively responsible experience in public health nursing or (2) A Masters Degree with preparation in Nursing Administration, Supervision or Consultation from a program accredited by the National League for Nursing or the American Public Health Association and at least three years of progressively responsible experience in public health nursing. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 600, 601, 602, 603, 604 and 1130, Health and Safety Code. s 1302. Director of the Public Health Laboratory. The director of a principal public health laboratory shall be a certified Public Health Microbiologist whose qualifications conform with the specifications for this position as established by the Department, pursuant to the provisions of the Health and Safety Code. The director shall have had four or more years of experience in public health laboratory work. The quality, variety and currency of this experience shall be satisfactory to the Department. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1000, 1002 and 1130, Health and Safety Code. s 1302.1. Director of a Branch Public Health Laboratory. The director of a branch public health laboratory shall be a certified Public Health Microbiologist whose qualifications conform with the specifications for this position as established by the Department, pursuant to the provisions of the Health and Safety Code. The director shall have had two or more years experience in public health laboratory work. The quality, variety and currency of this experience shall be satisfactory to the Department. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1000, 1002 and 1130, Health and Safety Code. s 1303. Health Educator. A health educator shall hold a master's degree with specialization in public or community health education awarded upon completion of a program of study accredited by the American Public Health Association. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code. s 1304. Director of Health Education. A director of health education appointed after November 1, 1962 who is responsible for the supervision of other professional staff shall have had, in addition to the professional training specified above, three or more years full-time paid experience in public health education, preferably in a local public health department. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code. s 1305. Public Health Nurse. (a) A public health nurse shall be currently licensed to practice as a registered nurse in California and shall: (1) Possess a California Public Health Nurse Certificate issued prior to March 5, 1954, or a Public Health Nurse Certificate issued under the provisions of Section 4500 et seq: and (2) By October 1, 1987 acquire training in the detection, prevention, reporting requirements and treatment of child abuse and neglect in accordance with Section 4501 of this chapter of working for a local health jurisdiction on or after January 1, 1981. (A) Directors of Public Health Nursing as defined in Section 1301 shall have the responsibility for verifying that all members of their Public Health Nursing Staff who have received Public Health Nurse Certificates prior to October 1, 1987, have received training which satisfies the requirement in Section 4501(a)(4). (B) The Department of Health Services shall have the responsibility for verifying that all nurses who receive a Public Health Nurse Certificate after October 1, 1987 have received training which satisfies the requirements in Section 4501(a)(4). Note: Authority cited: Sections 208, 600, 602 and 1130, Health and Safety Code. Reference: Section 600, 602, 605 and 1130, Health and Safety Code. s 1306. Occupational Health Trained Staff. Qualifications for each discipline included in the definition of trained staff shall conform to the following specifications: (a) Occupational Health Physician. M.D. degree and license to practice medicine in California, and either: (1) a master's degree in public health or occupational medicine and two years' experience in the full-time practice of occupational medicine, or (2) four years' experience in the full-time practice of occupational medicine, at least one year of which shall have been in a public health program. (b) Occupational Health Nursing Consultant. Baccalaureate degree and possession of a valid license as a registered nurse and a valid California Public Health Nurse certificate, and, either: (1) a master's degree in public health and two years' experience in the full-time practice of occupational health nursing, or (2) four years' experience in the full-time practice of occupational health nursing, and two years in a generalized public health nursing program. (c) Industrial Hygiene Engineer. Baccalaureate degree in engineering, and either: (1) a master's degree in public health or industrial hygiene and two years' experience in the full-time practice of industrial hygiene engineering, or (2) four years' experience in the full-time practice of industrial hygiene engineering, at least one year of which shall have been in a public health program. (d) Industrial Hygienist. Baccalaureate degree with major in a physical or biological science, and, either: (1) a master's degree in public health or industrial hygiene and two years' experience in the fill-time practice of industrial hygiene, or (2) four years' experience in the full-time practice of industrial hygiene, at least one year of which shall have been in a public health program, or (3) registration as a sanitarian in California with four years' experience in a local health department, three years of which shall have been in the full-time practice of industrial hygiene. (e) Industrial Hygiene Chemist. Baccalaureate degree with major in chemistry or biochemistry, and, either: (1) a master's degree in chemistry, biochemistry, or a related field of environmental chemistry and two years' experience as a professional chemist doing increasingly complex analytical procedures, or (2) four years' experience as a professional chemist doing increasingly complex analytical procedures. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Section 1130, Health and Safety Code. s 1307. Occupational Health Sanitarian. (a) Qualifications for an Occupational Health Sanitarian shall conform to the following specifications: (1) Registration as a sanitarian in California; (2) Three years' full-time experience in environmental sanitation; (3) One year of experience in an occupational health program of a local health department under direct supervision of an Industrial Hygiene Engineer or Industrial Hygienist as defined in Section 1306, or satisfactory completion of a two-week intensive training course in the recognition of occupational health hazards conducted by the California State Department of Public Health, or the equivalent of such a course conducted by an institution acceptable to the Department. (b) An Occupational Health Sanitarian with two years' full-time experience in that classification may qualify as an Industrial Hygienist for the purposes of Section 1276(j)(4) of this Code by completing two additional years of full-time experience in industrial hygiene under the direct supervision of an Industrial Hygiene Engineer or Industrial Hygienist qualified under Section 1306 above. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 519, 1111 and 1130, Health and Safety Code. s 1308. Director of Environmental Health. A director of Environmental Health shall hold a valid certificate of registration as a Sanitarian in the State of California and shall have had three or more years' experience in an environmental health agency (a Master's Degree in Public Health, Health Science, Public Administration, or related field may be substituted for one year of the required experience). Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1130 and 1155, Health and Safety Code. s 1325. Use of Funds. Funds available to local health departments under Chapter 8, Part 2, Division 1 of the Health and Safety Code may be expended for personnel, including but not limited to new or additional personnel and adjustments of salaries of existing personnel, maintenance and operation, equipment, and for capital expenditures. The funds may be used only to augment local appropriations provided for public health purposes, through the local public health department, including those functions listed in Article 2, but not including any of the following: (a) Medical, hospital and therapeutic care of physically handicapped children. (b) Maintenance of hospitals (including emergency hospitals and first aid stations), sanatoria and homes. (c) Garbage and refuse collection and disposal, and sewage disposal. (d) Street cleaning. (e) Inspection of building construction. (f) Inspection of plumbing. (g) Maintenance of dog or animal pounds. (h) Inspection of cemeteries. Note: Authority cited: Sections 100275, 100295 and 100950, Health and Safety Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code. s 1326. Restrictions on Matching Funds. For matching purposes as specified in Section 101255 of the Health and Safety Code, local health departments shall not include funds appropriated for functions listed under subsections (a) to (h), inclusive of Section 1325 above. Note: Authority cited: Sections 100275, 100295 and 100950, Health and Safety Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code. s 1327. Deposit and Expenditure of Funds. The governing body of each local health department shall set up a special fund or account as approved by the State Department and all payments received from the State by the governing body shall be deposited in that fund or account. No money shall be expended from such fund or account except for public health purposes in accordance with Division 1, Part 2, Chapter 8, of the Health and Safety Code, and the rules and regulations adopted by the State Department of Health Services pursuant thereto. Note: Authority cited: Sections 100275, 100295 and 100950, Health and Safety Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code. s 1328. Budget and Program. Local health departments shall submit a budget each year, showing a total plan for the expenditure of public health funds during the year, together with an outline of the program contemplated. The appropriation made in support of such budget shall also be reported. Note: Authority cited: Sections 100275, 100295 and 100950, Health and Safety Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code. s 1329. Reports. Local health departments shall report their expenditures, and shall submit reports of services and operations, upon forms provided for that purpose, at such times as the State Department of Health Services may require. Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code. Reference: Sections 1130, 1153 and 1154, Health and Safety Code. s 1351. Comprehensive Environmental Agency. "Comprehensive Environmental Agency" means an agency responsible to the board of supervisors which has been assigned the total function of providing environmental health and sanitation services and programs and other related environmental management functions which the board of supervisors may choose to delegate to the agency. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Section 1155.5, Health and Safety Code. s 1353. Environmental Health and Sanitation Services and Programs. "Environmental Health and Sanitation Services and Programs" means those agency provided services and programs which are required by the Director of the State Department of Health to meet local environmental health and sanitation needs. The term shall include additional environmentally related services and programs for which responsibility has been delegated to the agency by the county Board of Supervisors or Health District Board. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Section 1155.5, Health and Safety Code. s 1355. Director of Environmental Health. (a) There shall be a full-time Director of Environmental Health who shall be responsible for the administration of environmental health and sanitation services and programs. (b) The Director shall meet the following minimum qualifications: (1) Possession of a valid certificate of registration as a sanitarian in the State of California. (2) Three or more years' experience in an environmental health agency. A Master's Degree in Public Health, Health Science, Public Administration, or a related field may be substituted for one year of the required experience. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code. s 1357. Environmental Health Staff. There shall be an adequate staff of Registered Sanitarians meeting the qualifications established by the State Department of Health pursuant to provisions of the Health and Safety Code and other support personnel necessary to implement agency services and programs. Staffing units shall be equal to or greater than those levels provided by the environmental health unit of the health department prior to the transfer. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code. s 1359. Clerical Staff. There shall be sufficient, properly supervised clerical staff to meet agency needs. Staffing levels shall be equal to or greater than those levels provided by the environmental health unit of the health department prior to the transfer. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code. s 1361. Office Facilities. There shall be provided publicly accessible office facilities which shall be in operation full time during the normal county government work week. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code. s 1363. Conditions of Transfer. (a) Prior to transferring environmental health and sanitation services and programs from a local health department to an agency, the following shall be met: (1) The county board of supervisors or health district board shall authorize the total environmental health and sanitation services and programs to be transferred and maintained as a single organizational unit. (2) The Director of the State Department of Health shall give written approval for the transfer. (3) The proposed agency shall have a State Department of Health approved annual program plan. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code. s 1365. Powers and Duties of the County Health Officer. The county health officer shall retain powers, duties, and responsibilities relating to the protection of public health as set forth in Section 452 of the Health and Safety Code. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 452, 1155.5 and 1155.6, Health and Safety Code. s 1367. Powers and Duties of the District Health Officer. The district health officer shall retain powers, duties, and responsibilities relating to the protection of public health as set forth in Division 1, Part 2, Chapter 6 (commencing with Section 880) of the Health and Safety Code. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Division 1, Part 2, Chapter 6 (commencing with Section 880) (Pursuant to the Savings Clause in Statutes 1959, Chapter 380, Page 2305, Section 3, as amended by Statutes 1961, Chapter 1362, Page 3137, Section 1; Statutes 1968, Chapter 468, Page 1099, Section 1) and Sections 1155.5 and 1155.6, Health and Safety Code. s 1369. Powers and Duties of the Director of Environmental Health. (a) The Director of Environmental Health shall have powers and duties relating to environmental health and sanitation services and programs. (b) The powers and duties shall be clearly delineated in writing and shall provide for well-defined, direct lines of communication with the county or district health officer to assure coordination of public health programs and environmental health and sanitation services and programs. (c) These regulations shall not be deemed to diminish or impede any additional powers and duties of the Director of Environmental Health specified by statute, rule, regulation, resolution or order, or which may have been delegated to him by the county or district health officer. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code. s 1371. Basic Program. (a) Environmental health and sanitation services and programs shall be offered in accordance with an annual program plan approved by the State Department of Health and the applicable services and program standards an specified in the State Department of Health "Services in a Local Environmental Health and Sanitation Program," September 1976. The required services and programs shall be as follows: (1) Food. (2) Housing and institutions. (3) Radiological health in local jurisdictions contracting with the State Department of Health to enforce the Radiation Control Law pursuant to Sections 25600-25654 and Sections 25800-25876, Health and Safety Code. (4) Land development and uses. (5) Milk and dairy products in local jurisdictions maintaining an approved milk inspection service pursuant to Section 32503, Food and Agricultural Code. (6) Occupational health. (7) Water oriented recreation. (8) Safety. (9) Vector control. (10) Wastes management. (11) Water supply. (12) Additional environmentally related services and programs as required by the County Board of Supervisors, City Council, or Health District Board. (13) Air sanitation. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code. s 1373. Annual Program Plans. (a) Each county or district shall submit to the State Department of Health, annually for approval, program plans in each of the categories specified in Section 1371. (b) The annual program plans shall contain information pertaining to community needs, authority, goals, objectives, activities, personnel, and program evaluation as may be required by the State Department of Health. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code. s 1375. State Financial Aid. County or district eligibility for funds pursuant to Division 1, Part 2, Chapter 8 (commencing with Section 1100) of the Health and Safety Code shall be contingent upon fulfillment by the agency of all environmental health and sanitation requirements imposed upon county or district health departments by state statutes, rules, regulations and orders, and by local ordinances. Note: Authority cited: Sections 208, 1111 and 1155.6, Health and Safety Code. Reference: Sections 1155.5 and 1155.6, Health and Safety Code. s 1401. Application of Subchapter. Subchapter 3 shall apply to local jurisdictions that elect to apply for State funds under the provisions of Part 4.5 of Division 9 of the Welfare and Institutions Code. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16702, Welfare and Institutions Code. s 1403. Section Headings. Section headings contained herein shall not be deemed to govern, limit, or modify the provisions of any section. Note: Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16712, Welfare and Institutions Code. s 1405. Addendum. Note: Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16990, Welfare and Institutions Code. s 1407. Agreement. "Agreement" means the Standard Agreement for County Health Services entered into and signed by the governing body of each local jurisdiction and the Director of the State Department of Health Services which specifies the conditions under which monies shall be transferred to each local jurisdiction from the County Health Services Fund pursuant to Part 4.5 of Division 9 of the Welfare and Institutions Code. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16704(b), Welfare and Institutions Code. s 1409. Allocation. Note: Authority cited: Section 16712, Welfare and Institutions Code. Reference cited: Sections 16702 and 16704, Welfare and Institutions Code. s 1411. Annual Local Jurisdiction Budget. "Annual Local Jurisdiction Budget" means the official local jurisdiction budget adopted each year by the governing body of the local jurisdiction. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16990, Welfare and Institutions Code. s 1411.1. Benefits Chart. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code. s 1413. Budget. Note: Authority cited: Section 16712, Welfare and Institutions Code. Reference cited: Section 16700, Welfare and Institutions Code. s 1415. City Health Services. "City health services" means public health services, outpatient health services, and inpatient health services provided directly by a city or financed or purchased by a city through grants, contracts, or agreements, but not including services provided pursuant to Division 5, Welfare and Institutions Code, or Division 10.5, Health and Safety Code. Note: Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16701(c), Welfare and Institutions Code. s 1417. County Health Services. "County health services" means public health services, outpatient health services, and inpatient health services provided directly by a local jurisdiction or financed or purchased by a local jurisdiction through grants, contracts, or agreements but not including services provided: (1) Pursuant to Division 5, Welfare and Institutions Code. (2) Pursuant to Division 10.5, Health and Safety Code. (3) In Fiscal Year 1977-78 which are not part of the reported net county costs for Fiscal Year 1977-78. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16701(a), Welfare and Institutions Code. s 1418. County Health Services Allocation. "County Health Services Allocation" means monies disbursed from the County Health Services Fund established pursuant to subdivision (a) of Section 16703, Welfare and Institutions Code, in an amount specified in the Standard Agreement for County Health Services entered into and signed by duly authorized local jurisdiction officials and the Director of Health Services. The "County Health Services Allocation" consists of an amount based on county population, in the case of a county, and may include an amount based on net costs budgeted by a local jurisdiction for the provision of health services. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700, 16702 and 16704, Welfare and Institutions Code. s 1419. County Health Services Fund. "County Health Services Fund" means the fund created by Section 16703, subdivision (a), Welfare and Institutions Code, for deposit of monies appropriated for distribution to the local jurisdictions pursuant to Part 4.5 of Division 9 of the Welfare and Institutions Code. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16703, Welfare and Institutions Code. s 1420.1. County Medical Services Program. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code. s 1420.2. County Medical Services Program Account. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709(d), Welfare and Institutions Code. s 1420.3. County Medical Services Program Contract. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code. s 1420.4. Declaration of Intent to Enter into Contract. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code. s 1420.5. County Medical Services Program Reserve Account. Note: Authority cited: Section 10725, Welfare and Institutions Code; and Section 100275, Health and Safety Code. Reference: Section 16709(g), Welfare and Institutions Code. s 1421. Department. "Department" means the State Department of Health Services. Note: Authority cited: Section 16712, Welfare and Institutions Code. Reference cited: Section 16702, Welfare and Institutions Code. s 1422. Director. "Director" means the Director of the State Department of Health Services. Note: Authority cited: Section 16712, Welfare and Institutions Code. Reference cited: Section 16700, Welfare and Institutions Code. s 1422.1. Eligible Contract County. "Eligible Contract County" means a county which has requested the transfer of funding pursuant to Section 1157.5 of the Health and Safety Code. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16704, Welfare and Institutions Code. s 1422.3. Eligibility Manual. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code. s 1423. Expenditures. "Expenditures" means funds budgeted or expended to support health program operations and includes: (1) Health services supplied or provided for through purchase or contract. (2) Salaries and employee benefits. (3) Operation and maintenance costs. (4) Depreciation of facilities owned by a local jurisdiction. (5) Administrative costs. (6) Federal Revenue Sharing Funds budgeted or expended for these health activities. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16708, Welfare and Institutions Code. s 1425. Fixed Assets, Fixtures, Structures and Improvements. Note: Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16708, Welfare and Institutions Code. s 1427. Inpatient/Outpatient Services. "Inpatient/outpatient services" means those medical care services provided directly by a local jurisdiction or purchased or provided through contracts with other providers which may include but not be limited to: (1) General acute inpatient hospital services. (2) Outpatient services administered by hospital staff, non-hospital based county clinics, and community clinics funded by a local jurisdiction. (3) Skilled nursing facilities. (4) Licensed home health agencies. (5) Rehabilitation facility services. (6) Inpatient/outpatient services for criminal justice inmates. (7) Ambulance and related emergency services. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16701(a), Welfare and Institutions Code. s 1428. Local Jurisdiction. "Local Jurisdiction" means a county, the San Joaquin Local Health District, a city which has not transferred to the county enforcement authority of applicable health statutes and regulations, or a city which provides public health services pursuant to a contract with a county through an organized health department recognized by the Department. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16700, Welfare and Institutions Code. s 1429. Maximum Allocation. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16705, Welfare and Institutions Code. s 1430. May, Shall, Should. "May" means permissible. "Shall" means mandatory. "Should" means desirable. Note: Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16712, Welfare and Institutions Code. s 1430.1. Medically Indigent Services Account. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803(b), Welfare and Institutions Code. s 1430.2. Medically Indigent Services Allocation. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803, Welfare and Institutions Code. s 1430.3. Multi-Year Budget. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16990, Welfare and Institutions Code. s 1430.4. Multi-Year Plan. "Multi-Year Plan" means the County Health Services three-year plan which describes proposed county health services in a format specified by the Department and submitted by a local jurisdiction pursuant to Part 4.5 of Division 9 of the Welfare and Institutions Code. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16700, Welfare and Institutions Code. s 1431. Net City Costs for Health Services. Note: Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16801(e), Welfare and Institutions Code. s 1432. Net County Costs for Health Services. "Net county costs for health services" means expenditures for county health services less revenues received for county health services plus Federal Revenue Sharing funds budgeted or expended for county health services. Note: Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16701(b), Welfare and Institutions Code. s 1433. Plan. Note: Authority cited: Section 16712, Welfare and Institutions Code. Reference: Section 16700, Welfare and Institutions Code. s 1435. Public Health Services. "Public health services" means those health promotion, surveillance, and disease prevention services designed to protect the health of the public, population groups, and individuals. Note: Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16801, Welfare and Institutions Code. s 1437. Reported Net County Costs for Fiscal Year 1977-78. "Reported net county costs for Fiscal Year 1977-78" means those net county costs for health services for Fiscal Year 1977-78 which were originally reported to the Department pursuant to Section 20 of Chapter 292 of the Statutes of 1978 or amended pursuant to County Health Services Bulletin #2- 1979. These costs are those exact amounts listed below by county except that the amount listed for Alameda County does not include the net costs for Berkeley and the amount listed for San Joaquin County does not include the net costs for the San Joaquin Local Health District: Alameda $22,649,584 Orange $21,552,624 Alpine $23,704 Placer $812,227 Amador $491,123 Plumas $115,890 Butte $1,179,463 Riverside $10,248,905 Calaveras $35,861 Sacramento $9,646,438 Colusa $273,457 San Benito $80,536 Contra Costa $11,924,448 San Bernardino $7,920,785 Del Norte $106,435 San Diego $10,797,538 El Dorado $1,015,867 San Francisco $40,124,175 Fresno $11,853,293 San Joaquin $3,006,398 Glenn $121,505 San Luis Obispo $1,889,127 Humboldt $1,238,729 San Mateo $8,280,966 Imperial $1,035,813 Santa Barbara $4,647,590 Inyo $593,006 Santa Clara $16,715,698 Kern $8,830,127 Santa Cruz $2,592,658 Kings $718,199 Shasta $563,682 Lake $64,719 Sierra $15,916 Lassen $401,705 Siskiyou $285,207 Los Angeles $177,838,404 Solano $1,006,584 Madera $311,721 Sonoma $1,439,658 Marin $1,760,674 Stanislaus $4,384,380 Mariposa $24,291 Sutter $999,607 Mendocino $547,607 Tehama $474,072 Merced $1,301,322 Trinity $318,281 Modoc $164,312 Tulare $2,317,423 Mono $424,737 Tuolumne $328,064 Monterey $4,200,837 Ventura $5,803,840 Napa $820,398 Yolo $1,419,400 Nevada $171,556 Yuba $334,214 Note: Authority cited: Section 16812, Welfare and Institutions Code. Reference: Section 16990, Welfare and Institutions Code. s 1439. Revenues. "Revenues" means income budgeted or received for health services from fees, fines, grants, subventions, and/or monetary aid from government agencies but excluding property taxes, Federal Revenue Sharing, and monies provided pursuant to Part 4.5 of Division 9 of the Welfare and Institutions Code. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16700, Welfare and Institutions Code. s 1440. "Update." Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16936, Welfare and Institutions Code. s 1445. Multi-Year Plan and Budget Submission. (a) Beginning in 1983, and each third subsequent year thereafter, the governing body of each county, the Cities of Berkeley, Long Beach, and Pasadena, and the San Joaquin Local Health District shall adopt and shall submit a Multi-Year Plan and Budget to the Director in the form and in accordance with procedures specified in this Article on or before September 15. (b) Beginning in 1984, and each year thereafter, the governing body of each county, the Cities of Berkeley, Long Beach, and Pasadena, and the San Joaquin Local Health District shall adopt and shall submit an update of its adopted Multi-Year Plan and Budget to the Director in the form and in accordance with procedures specified in this Article on or before September 15. (c) Copies of the Multi-Year Plan and Budget and Update shall be submitted to the appropriate area health planning agency simultaneously to submission to the Department. (d) Submission of a Multi-Year Plan and Budget or Update shall not: (1) Relieve any county of its indigent health care obligation under Section 17000, Welfare and Institutions Code. (2) Restrict the ability of the State or any interested person or persons to obtain any judicial relief to which there is entitlement. NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16711, Welfare and Institutions Code. s 1451. Multi-Year Plan and Budget and Update Content. (a) The Multi-Year Plan and Budget submitted by each local jurisdiction shall contain but not be limited to a: (1) Narrative section which provides a description of public health, and inpatient and outpatient services be provided or contracted for by the local jurisdiction. (2) Budget section which details proposed expenditures, revenues and net county costs for county health services. (3) Certification section containing signatures necessary for the formal transfer of State and/or Federal monies to the local jurisdiction pursuant to the Multi-Year Plan and Budget. (b) The Multi-Year Plan and Budget shall include only health programs, services, and administrative support that are part of the reported net county costs for Fiscal Year 1977-78 and may include any new health programs which have been instituted since Fiscal Year 1977-78. (c) Health programs and associated costs which existed during Fiscal Year 1977- 78 and which are not part of the reported net county costs for Fiscal Year 1977-78 shall be excluded from the Multi-Year Plan and Budget, but may be in the Addendum identified in (d). (d) The Multi-Year Plan and Budget may contain an Addendum which includes narrative descriptions and estimated expenditures, revenues, and net county costs for health services, exclusive of mental health, alcohol, and drug abuse treatment, not reported in the Plan and Budget. (e) In those counties, except the County of Alameda, where the governing body of a city has not transferred to the county enforcement authority of applicable public health statutes and regulations or where public health services are provided b a city pursuant to a contract with a county, such a county shall, in the Multi-Year Plan and Budget, Update, and Agreement, provide for continuation and funding of such services. (f) The Multi-Year Plan and Budget shall include only fiscal information which is consistent with the regulations on capital expenditures, depreciation, and administrative overhead as listed below: (1) Capital expenditures for local jurisdiction structures and fixtures, and improvements to local jurisdiction structures and fixtures shall not be considered allowable costs. (2) Depreciation for local jurisdiction structures and fixtures, and improvements to local jurisdiction structures and fixtures shall be an allowable expense for purposes of applying for monies pursuant to 1466. Depreciation also shall be an allowable expense for purposes of applying for monies pursuant to 1465(a) only if the: (A) Reported net county costs for Fiscal Year 1977-78 included depreciation expenses for such local jurisdiction structures and fixtures, or improvements to local jurisdiction structures and fixtures; or, (B) Reported net county costs for Fiscal Year 1977-78 included capital expenditures for such local jurisdiction structures and fixtures, or improvements to local jurisdiction structures and fixtures; or, (C) Capital expense was incurred after June 30, 1978 and was for an allowable expense as determined by Department guidelines and regulations. (3) Expenditures for fixed assets involving inpatient or outpatient health services for persons certified eligible pursuant to Section 17000 of the Welfare and Institutions Code shall be depreciated and all other expenditures for fixed assets may be either expensed or depreciated, but not both. (4) Administrative overhead shall be listed as a single line item or distributed across all programs, but not both. (5) The Multi-Year Plan and Budget and Update shall include the Cost Allocation Summary presented annually to the State Controller's Office for the determination of indirect costs for Federal grants and contracts. (g) The Multi-Year Plan and Budget and Update shall include information pertaining to medical services provided to indigent county residents. Specifically the Plan and Budget and Update shall include but not be limited to: (1) The eligibility criteria the county uses to determine whether a person is certified as eligible for health services under Section 17000 of the Welfare and Institutions Code. (2) A description of the county's eligibility process used to determine whether a person is eligible for services under Section 17000 of the Welfare and Institutions Code. (3) A description of how county residents are notified or informed of the availability of county financed services pursuant to Section 17000 of the Welfare and Institutions Code. (4) A listing of services or benefits which are provided. (5) A listing of the location of services and how the county ensures reasonable accessibility of such services. (6) A description of the county's fee collection policies, fee schedules, procedures and expected revenues for persons covered by Section 17000 of the Welfare and Institutions Code. (7) An estimate of the Section 17000 target population size and an estimate of the number of persons who will use the services/benefits. (8) A projection of the estimated costs of serving the medically indigent population under Section 17000 of the Welfare and Institutions Code. (h) The annual Update of the Multi-Year Plan and Budget submitted by the local jurisdiction shall contain but not be limited to: (1) The requirements specified in subdivisions (a) through (g), and any other instructions, forms, and guidelines developed by the Department pertaining to the annual Update. (2) The Update shall not duplicate any of the material in the Multi-Year Plan and Budget. (3) The Update also shall serve as a progress report evaluating what has been accomplished over the past year and shall provide specific time-limited measurable objectives in relation to each of the elements in the Multi-Year Plan and Budget during the applicable fiscal year. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700, 16709, 16710 and 16711, Welfare and Institutions Code. s 1457. Plan and Budget Review. (a) The Department shall review the County Health Services Multi-Year Plan and Budget or Update submitted by each local jurisdiction to ensure as a minimum that the Multi-Year Plan and Budget or Update: (1) Have been submitted in accordance with the procedures specified by the Director. (2) Are in the format and cover the content specified by the Director. (3) Contain the necessary signatures and certifications as specified by the Director. (4) Contain budgeted financial data by budget unit as specified in the Annual County Budget and are presented in the format specified by the Department. (5) Include copies of revenue and appropriations pages from the Annual County Budget for each budget unit listed pursuant to (4). Interim documentation may be submitted until an official Annual County Budget has been printed. (6) Are in conformance with: (A) Uniform accounting standards and procedures. (B) Fiscal policies stated in these regulations. (C) Guidelines issued by the Department. (b) Based on the review of the Multi-Year Plan and Budget or Update, the Department may require a local jurisdiction to submit additional data or information in a format specified by the Department. (1) The data or information shall be requested to augment an incomplete or inaccurate submission. (2) Any local jurisdiction which does not comply with the request shall be considered as not having submitted a Multi-Year Plan and Budget or Update in conformance with Department guidelines and regulations and shall not receive per capita monies from the County Health Services Fund. (c) All fiscal information submitted as part of the Multi-Year Budget or Update shall be verifiable and shall be subject to State audit. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16704, Welfare and Institutions Code. s 1465. County Health Services Allocation. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16704 and 16705, Welfare and Institutions Code. s 1466. Medically Indigent Services Allocation. (a) The Department shall compute each county's Medically Indigent Services Allocation in accordance with Subdivision (d) of Section 16703 of the Welfare and Institutions Code. (b) A county may apply for all or a portion of its total allocation pursuant to 1473(c). If the County chooses to apply for these funds, it shall be bound by conditions and limitations contained in paragraph (1) of subdivision (c) of Section 16704 of the Welfare and Institutions Code on the use of such funds. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16703(b), 16704(c) and 16709(a), Welfare and Institutions Code. s 1467. Medically Indigent Services Application. (a) In order to apply for the Medically Indigent Services Allocation, a county shall submit to the Department an Application adopted by the County Board of Supervisors prior to the disbursement of funds from the Medically Indigent Services Account. The Application shall be in a form and in accordance with procedures specified by the Director and shall contain but not be limited to the following: (1) Unless a county has contracted with the Department pursuant to Article 6, an assurance by the County that it will incur no less in net costs of county funds for county health services in any fiscal year than the amount required to obtain the maximum allocation as specified in 1465(a). (2) An assurance by the county that funds allocated pursuant to 1466 shall be expended only for health services included in Sections 14132 and 14021 of the Welfare and Institutions Code for persons certified eligible pursuant to Section 17000 of the Welfare and Institutions Code. A county shall not be bound by utilization control provisions which are specified within Sections 14132 and 14021. (3) An assurance by the county that funds allocated pursuant to 1466 shall not be expended for costs of services specified in county Short-Doyle plans which are in excess of the 125 percent limitation specified in Section 5705.1 of the Welfare and Institutions Code. Note: Authority cited: Section 16712, Welfare and Institution Code; and Statutes of 1982, Chapter 1594, Section 8(c). Reference: Sections 16704(c) and 16706, Welfare and Institutions Code. s 1469. Agreement. (a) Upon completion of the Departmental review of a local jurisdiction's Multi-Year Plan and Budget or Update, the Department shall issue an Agreement for review and signature by appropriate officials representing the local jurisdiction. The agreement shall include, as appropriate, but shall not be limited to: (1) The total funds to be allocated to the county based on population as specified in 1465(a)(1). (2) The total funds to be allocated to the county based on budgeted allowable expenditures, revenues, and net costs as specified in 1465(a)(2). (3) The total funds to be allocated to an Eligible Contract County solely for public health services as specified in 1465(a)(3). (4) The total funds to be allocated to the City of Berkeley as specified in 1465 (a)(5). (5) The total funds to be allocated to the San Joaquin Local Health District solely for public health services as specified in 1465(a)(6). (6) The net costs of local jurisdiction funds for health services that must be incurred by the local jurisdiction in order to receive the total allocation specified in 1465(a). (7) The sharing ratio of State funds as specified in (2), (3), (4) and (5) to the local jurisdiction funds as specified in (6). The sharing ratios shall not exceed those specified in 1465(h), as applicable. (8) An assurance by the local jurisdiction that it agrees to expend local jurisdiction funds for net county costs for county health services in the amounts specified in 1465(c), (d), (e), and (f), as applicable. (9) An assurance by the local jurisdiction that the health services provided by the Agreement will be in general accordance with the local jurisdiction's Multi-Year Plan and Budget or Update. (10) An assurance by the local jurisdiction that monies provided by the State under the terms of this Agreement will be used to finance health services as described in the Multi-Year Plan and Budget or Update and for no other purpose. (11) An assurance by the local jurisdiction that sufficient records, files and documentation will be maintained for State review concerning program activity and expenditures made under this Agreement and will be accessible for a period of at least four years from the expiration of this Agreement, or in the event of a State audit, until the audit has been resolved. (12) An assurance by the local jurisdiction that access will be provided during normal working hours to authorize representatives of the Department and of other State agencies to all records, files, and documentation related to the Agreement. (13) An assurance by the local jurisdiction that reports will be provided as required by the Department. (b) The Agreement shall also include provisions pertaining to medically indigent services funds received pursuant to 1466. The provisions shall include but not be limited to: (1) The total funds to be allocated to the county based on the allocation specified in 1466. (2) The net costs for health services that must be incurred by the county in order to receive the allocation specified in 1466. (3) An assurance by the county that it will incur no less in net costs of county funds for county health services in any fiscal year than the amount required to obtain the maximum allocation specified in 1465. (4) An assurance by the county that funds allocated pursuant to 1466 shall be expended only for health services included in Sections 14132 and 14021 of the Welfare and Institutions Code for persons certified eligible pursuant to Section 17000 of the Welfare and Institutions Code. A county shall not be bound by utilization control provisions which are specified within Sections 14132 and 14021. (5) An assurance by the county that funds allocated pursuant to 1466 shall not be expended for costs of services specified in county Short-Doyle plans which are in excess of the 125 percent limitation specified in Section 5705.1 of the Welfare and Institutions Code. (6) The total funds to be provided by the State as specified in (a) and in (b)(1) above, under the terms of the Agreement. (c) The Agreement shall constitute a contractual obligation. (d) A local jurisdiction that has not submitted a signed Agreement to the Department by the end of a current fiscal year shall be subject to recoupment of any funds disbursed pursuant to (b)(1). (e) A local jurisdiction that does not conform with any or all of the terms of the Agreement may be subject to recoupment of funds disbursed to that local jurisdiction. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16704 and 16706, Welfare and Institutions Code. s 1473. Disbursement. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803, Welfare and Institutions Code. s 1475. Reports. (a) For Fiscal Year 1979-80 and annually thereafter, each local jurisdiction shall submit to the Department a report of estimated actual expenditures, revenues, and net county costs for services provided in accordance with the Multi-Year Plan and Budget or Update. (1) The report shall be submitted in a form and in accordance with procedures specified by the Department. (2) The report shall be due on November 15 in the year following the fiscal year for which data s being reported. (b) For Fiscal Year 1979-80 and annually thereafter, each local jurisdiction shall submit to the Department a report of actual expenditures, revenues and net county costs for services provided in accordance with the Multi-Year Plan and Budget or Update. (1) The report shall be submitted in accordance with the format and procedures as specified by the Department. (2) The report shall be due on November 15 in the second year following the fiscal year for which data is being reported. (c) Beginning on November 15, 1981, and annually thereafter each local jurisdiction shall prepare and submit to the Department a report describing health services provided by the local jurisdiction pursuant to Part 5 (commencing with Section 17000) of Division 9 of the Welfare and Institutions Code. (1) The report shall be submitted in accordance with the procedures and timetable as established by the Department. (2) The report shall include but not be limited to information covering the following: (A) Eligibility standards (B) Services provided (C) Resources utilized (D) Fees collected (E) Target population size (F) Costs (d) The Director shall withhold part or all payment of County Health Services Funds to a local jurisdiction, unless the reports specified in (a) through (c) have been received by the Department. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16706 and 16716, Welfare and Institutions Code. s 1477. Recoupment. (a) For Fiscal Year 1979-80 and annually thereafter, the Department shall review the report specified in 1475(a), which shall serve as the initial basis for the recovery of funds not expended in accordance with the Agreement described in 1469. (1) The Department: (A) Shall determine whether or not the county has reported only net costs specifically allowed pursuant to Department guidelines and regulations. (B) May disallow reported costs that are inaccurate or are not allowable costs for county health services or for health services provided to persons eligible pursuant to Section 17000 of the Welfare and Institutions Code. (2) The Department shall notify the local jurisdiction in writing of its determinations and allowances made pursuant to (1). (3) Notification shall be sent to the local jurisdiction's governing body, Auditor-Controller, Administrative Officer, and the Health Agency Director, Health Officer, and Hospital Administrator, as applicable. (4) The notification for the fiscal year shall list: (A) Aggregate net county costs specified in the Agreement. (B) Estimated actual net county costs as reported pursuant to 1475(a). (C) The difference between the two amounts. (5) If the estimated actual net county costs are less than the aggregate net county costs specified in the Agreement, the notification shall declare the Department's intent to do one or a combination of the following in order to recoup the State portion of the funds specified in (4)(C): (A) Adjust subsequent payments to the local jurisdiction from the County Health Services Fund. (B) Negotiate a repayment plan for the local jurisdiction. (C) Withhold the appropriate amount from other State funds payable to the local jurisdiction. (b) For Fiscal Year 1979-80 and annually thereafter, the Department shall review the report specified in 1475(b) which shall serve as the final basis for recoupment of funds not expended in accordance with the Agreement described in 1469, unless the report is modified by actual audit findings officially adopted by the State. (1) The Department: (A) Shall determine whether or not the local jurisdiction has reported only net costs specifically allowed pursuant to Department guidelines and regulations. (B) May disallow reported costs that are inaccurate or are not allowable after verifying the information with the local jurisdiction and notifying them of the proposed disallowance. (2) The Department shall notify the local jurisdiction in writing of its determinations and disallowances made pursuant to (1) and of any difference between the actual net county costs reported pursuant to 1475(b) and the estimated actual net county costs reported pursuant to 1475(a). (3) Notification shall be sent to the local jurisdiction's governing body, Auditor-Controller, Administrative Officer, and the Health Agency Director, Health Officer, and Hospital Administrator, as applicable. (4) The notification for the fiscal year shall list the: (A) Actual net county costs as reported pursuant to 1475(b). (B) Estimated actual net county costs as reported pursuant to 1475(a). (C) Difference between the two amounts. (5) If the actual net county costs are less than the estimated actual net county costs the notification shall declare the Department's intent to do one or a combination of the following in order to recoup the State portion of the funds specified in (4)(c): (A) Adjust subsequent payments to the local jurisdiction from the County Health Services Fund. (B) Negotiate a repayment plan for the local jurisdiction. (C) Withhold the appropriate amount from other State funds payable to the local jurisdiction. (c) The governing body of the local jurisdiction shall have twenty-one (21) working days, following receipt of notification pursuant to (a)(2) or (b)(2) to appeal the Department's decision. The appeal shall be in accordance with the format and procedures specified by the Department. (d) The Department may adjust the monthly payments made to a county pursuant to an Agreement as specified in 1469(b) if the county fails to expend such funds as specified in the Agreement. (e) The Department shall recover any unexpended funds disbursed to county as specified in 1473(b) for medically indigent services in accordance with the procedures specified in the Agreement. (f) The Department shall recover any funds not expended pursuant to 1469(b) in accordance with the procedures specified in the Agreement. Note: Authority cited: Section 16712, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16706, Welfare and Institutions Code. s 1481. Special Needs and Priorities. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16707, Welfare and Institutions Code. s 1485. Purpose. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code. s 1486. Conditions. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code. s 1487. Scheduling. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code. s 1489. Notification. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code. s 1491. Conduct. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code. s 1493. Findings. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16705, Welfare and Institutions Code. s 1495. Transmittal. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code. s 1497. Determinations. Note: Authority cited: Section 16812, Welfare and Institutions Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16705 and 16705.5, Welfare and Institutions Code. s 1498. County Medical Services Program. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code. s 1498.1. Declaration of Intent to Contract. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16703 and 16709, Welfare and Institutions Code. s 1498.2. Small County Advisory Committee. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code. s 1498.3. Contract. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16704 and 16709, Welfare and Institutions Code. s 1498.4. Eligibility. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 159, Section 87(c). Reference: Sections 16703, 16706 and 16709, Welfare and Institutions Code. s 1498.5. Benefits. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code. s 1498.6. Administration. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16709 and 16717, Welfare and Institutions Code. s 1498.7. Fiscal. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16703 and 16709, Welfare and Institutions Code. s 1498.8. Liabilities. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Section 16709, Welfare and Institutions Code. s 1498.9. Reporting. Note: Authority cited: Section 10725, Welfare and Institutions Code; Section 100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16709 and 16716, Welfare and Institutions Code. s 1500. Indian. "Indian" means any person who is: (a) Identified as an Indian on the rolls maintained by the Bureau of Indian Affairs, (b) Identified as an Indian on the rolls maintained by an Indian tribe, band, or other organized group of Indians, in any state, (c) A descendant in the first or second degree of any person identified at any time on a roll referred to in subsection (a) or (b), (d) Declared to be a member of a tribe or a descendant in the first or second degree of a member of a tribe by the tribal council of his or her tribe, or (e) A descendant in any degree from a member of a tribe which has been declared to be terminated by the United States government. However, any person qualifying under this subsection must be at least one quarter Indian blood. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 429.30, 429.31 and 429.32, Article 14, Chapter 2, Part 1, Division 1, Health and Safety Code. s 1501. Indian Tribe. "Indian Tribe" means any Indian tribe, band, nation or other organized group or community, which is determined to be eligible for the special programs and services provided by the United States or State of California, to Indians because of their status as Indians. s 1502. Existing Indian Health Programs. "Existing Indian Health Programs" means any program which provided, as of September 8, 1975, direct health services as defined in Section 1503 under the supervision of a licensed physician and surgeon, dentist, optometrist, or nurse. s 1503. Direct Health Services. "Direct Health Services" means one or more of the following services provided under the supervision of a licensed provider of health services acting within the scope of his or her license: (a) Primary health care consisting of diagnostic, treatment and health maintenance services. (b) Outreach, education, referral, follow-up services and assistance to the individual in obtaining services from other agencies to which he is entitled (health advocacy). (c) Specialized health services as listed below: (1) Screening and disease detection services. (2) Alcohol and drug abuse detoxification services. (3) Dental health services. (4) Services leading to the prevention of vision and hearing loss and the restoration of vision and hearing. (5) Family planning services. (6) Maternal and child health services. (7) Medical care of chronic conditions. s 1504. Licensed Provider of Health Services. "Licensed Provider of Health Services" for the purposes of Section 1503 means: (a) A provider practicing in California licensed by the appropriate healing arts board. (b) An individual employed by the Federal government in the practice of the healing arts on tribal lands. s 1505. Department. "Department" means the State Department of Health Services. Note: Authority cited: Sections 208 and 1182.2(d), Health and Safety Code. Reference: Section 1182.2, Health and Safety Code. s 1506. Director. "Director" means the Director of the State Department of Health Services. Note: Authority cited: Sections 208 and 1182.2(d), Health and Safety Code. Reference: Section 1182.2, Health and Safety Code. s 1507. Indian Medicine and Traditional Health Practices. "Indian Medicine and Traditional Health Practices" means traditional practices of Indian medicine which are native to an Indian community, which are accepted by that Indian community as handed down through the generations and which can be established through the collective knowledge of the elders of that Indian community. Note: Authority cited: Sections 208 and 1182.2(d), Health and Safety Code. Reference: Section 1182.2, Health and Safety Code. s 1520. Indian Health Policy Panel. An Indian Health Policy Panel established by the Director shall advise the Director regarding policy for Indian health. s 1521. Panel Membership. Panel membership shall consist of four representatives of the California Rural Indian Health Board, four representatives of the California Urban Indian Health Council, and two individuals appointed by the Director. The representatives of the California Urban Indian Health Council and the California Rural Indian Health Board shall be appointed by the Council and the Board. s 1530. Financial Assistance to Indian Health Programs. Monies available under Chapter 606, Statutes of 1975, and any funds available to carry out provisions of Article 14 (commencing with Section 429.30) of Chapter 2 of Part 1 of Division 1 of the Health and Safety Code shall be allotted for the following purposes: (a) Direct health services as defined under Section 1503 of these regulations. (b) Technical assistance by individuals experienced in the delivery of health services including, but not limited to, health professionals, economists, sociologists, accountants, legal advisors, midwives (to the extent otherwise permitted by law), and other experts in Indian medicine and traditional health practices. Technical assistance may be provided by State staff, by consultants under contract with the State, or through contracts with local public and voluntary health organizations or existing Indian health programs. (c) Training for health workers in Indian programs provided in the following manner: (1) On the job training using workers in the program or individuals from other projects or agencies as instructors. (2) Short term training sponsored by an educational facility not to exceed two weeks duration at any one time or one day per week over a three-month period. (3) Tuition for the course work required by a staff member for the A.A., B.A. degree or advanced degree. (d) Studies concerning the health needs, resources and practices of California Indians. Special emphasis shall be placed on the area of Indian medicine and traditional health practices. s 1531. Allocation of Financial Assistance to Indian Health Programs. (a) Funds shall be allocated for health services which are supplemental to those available from the Federal or State government. State funds available for the purposes of the Indian Health Service Program (Article 14 (commencing with Section 429.30) of Chapter 2 of Part 1 of Division 1 of the Health and Safety Code) shall not duplicate or replace any commitment made by the Federal government. (b) No funds shall be provided from those appropriated for the purposes of the Indian Health Service Program for types of services for which Indians are eligible under other programs and for which other funds are available, including but not limited to the following types of services: (1) Family planning. (2) Supplemental Feeding for Women, Infants and Children (WIC). (3) Alcoholism or substance abuse services. (4) Hospitalization other than for emergency services, if an individual is eligible for medical care under Title XVIII or XIX of the Federal Social Security Act, under the Workmen's Compensation Statutes of California, from the Veteran's Administration or other similar programs or when a public health service hospital is accessible or if an individual has private health insurance. (5) Maternal and Child Health. (6) Crippled Childrens Services. (7) Community Mental Health Services Program (Short-Doyle). (8) Developmental Disability Program (Regional Centers). s 1532. Allocation Formula. (a) In the determination of the allocation of State funds the following factors shall be considered: (1) Need as demonstrated by: (A) The number of individuals to be served. (B) The availability of other resources in the service area. (C) The accessibility of resources in the service area. (D) Higher costs of providing health services in the areas served. (2) The ability of the proposed program to meet that need, as determined by: (A) Adequate personal services. (B) Sufficient operating expenses. (3) Compliance with statewide plan for Indian health services and existing priorities for services. (4) Compliance with local Indian health plan. (5) The demonstrated ability of the Indian health program to carry out the proposed services. s 1533. Reimbursement for Service. (a) The programs shall maximize utilization of reimbursement from third-party payors. (b) Where an Indian is eligible for health benefits from third-party payors and the service is provided by an existing Indian health program, the revenue collected from third-party payors shall be used to increase the services offered by the program. s 1534. To Qualify for Funding. (a) To qualify for funding an existing Indian health program shall be administered by a nonprofit corporation organized under the laws of this State or by an Indian tribe as defined in Section 1501. The board of directors or trustees of such corporation shall be composed of a majority of Indians as defined in Section 1500. Note: Authority cited: Sections 208 and 1182.2(d), Health and Safety Code. Reference: Sections 1182 and 1182.2, Health and Safety Code. s 1535. Criteria for Reimbursement of Direct Services. (a) Salaries, travel expenses, and per diem rates for employees of existing Indian health programs shall be no greater than the rate set for State employees in like circumstances. Exceptions shall be granted only when no provider of services is available to the program at the rate set for State employees. (b) Rates for reimbursement of services provided on a fee-for-service basis shall be no greater than the prevailing rates in the community in which the provider of services offers services. s 1540. Confidentiality of Information. (a) All patient files and information maintained or possessed by an existing Indian health program shall be treated as privileged communication, shall be held confidential, and shall not be divulged without the written consent of the individual or his personal representative, (or the parent or guardian, in the case of a minor), except as may be necessary to provide emergency services to the individual, to file a claim for benefits on behalf of the individual, or as required by the Department to administer this program. Information may be disclosed in summary, statistical, or other form which does not identify the particular individual. (b) Services shall be provided in a manner that respects the privacy and dignity of the individual. s 1541. Informed Consent. (a) No individual shall be denied benefits available under the Indian Health Service Program for failure to accept any form of offered treatment. In the case of any medical treatment offered or given to an individual under the Indian Health Services Program, a signed consent form shall be obtained indicating that the individual has been informed of all known risks, benefits, and alternatives to the proposed treatment. This requirement may be waived in the case of emergencies. In the case of minors, the consent form shall be signed by the parent or guardian. s 2000. Joint Regulations for Handicapped Children. CROSS-REFERENCE: See Title 2, Division 9, Chapter 1, Articles 1-9, Sections 60000-60610, not consecutive. <<(Chapter Originally Printed 8-15-45)>> s 2500. Reporting to the Local Health Authority. (a) The following definitions shall govern the interpretation of this Subchapter. (1) 'CDC' means the Centers for Disease Control and Prevention, United States Department of Health and Human Services. (2) 'CSTE' means the Council of State and Territorial Epidemiologists. (3) 'MMWR' means the Morbidity and Mortality Weekly Report. (4) 'Case' means (A) a person who has been diagnosed by a health care provider, who is lawfully authorized to diagnose, using clinical judgment or laboratory evidence, to have a particular disease or condition listed in subsection (j); or (B) a person who meets the definition of a case in Section 2564 - Diarrhea of the Newborn, Section 2574 - Food Poisoning, Section 2612 Salmonella Infections (Other than Typhoid Fever), Section 2628 - Typhoid Fever, or Section 2636 - Venereal Disease; or (C) a person who is considered a case of a disease or condition that satisfies the most recent communicable disease surveillance case definitions established by the CDC and published in the Morbidity and Mortality Weekly Report (MMWR) or its supplements; or (D) an animal that has been determined, by a person authorized to do so, to have rabies or plague. (5) 'Clinical signs' means the objective evidence of disease. (6) 'Clinical symptoms' means the subjective sensation of disease felt by the patient. (7) 'Communicable disease' means an illness due to a specific microbiological or parasitic agent or its toxic products which arises through transmission of that agent or its products from an infected person, animal, or inanimate reservoir to a susceptible host, either directly or indirectly through an intermediate plant or animal host, vector, or the inanimate environment. (8) 'Director' means State Director of Health Services. (9) 'Drug susceptibility testing' means the process where at least one isolate from a culture of a patient's specimen is subjected to antimicrobial testing to determine if growth is inhibited by drugs commonly used to treat such infections. (10) 'Epidemiological risk factors' means those attributes, behaviors, exposures, or other factors that alter the probability of disease. (11) 'Epidemiologically linked case' means a case in which the patient has/has had contact with one or more persons who have/had the disease, and transmission of the agent by the usual modes of transmission is plausible. (12) 'Foodborne disease' means illness suspected by a health care provider to have resulted from consuming a contaminated food. (13) 'Foodborne disease outbreak' means an incident in which two or more persons experience a similar illness after ingestion of a common food, and epidemiologic analysis implicates the food as the source of the illness. There are two exceptions: even one case of botulism or chemical poisoning constitutes an outbreak if laboratory studies identify the causative agent in the food. (14) 'Health care provider' means a physician and surgeon, a veterinarian, a podiatrist, a nurse practitioner, a physician assistant, a registered nurse, a nurse midwife, a school nurse, an infection control practitioner, a medical examiner, a coroner, or a dentist. (15) 'Health officer' and 'local health officer' as used in this subchapter includes county, city, and district health officers. (16) 'In attendance' means the existence of the relationship whereby a health care provider renders those services which are authorized by the health care provider's licensure or certification. (17) 'Infection control practitioner' means any person designated by a hospital, nursing home, clinic, or other health care facility as having responsibilities which include the detection, reporting, control and prevention of infections within the institution. (18) 'Laboratory findings' means (A) the results of a laboratory examination of any specimen derived from the human body which yields microscopical, cultural, immunological, serological, or other evidence suggestive of a disease or condition made reportable by these regulations; or (B) the results of a laboratory examination of any specimen derived from an animal which yields evidence of rabies or plague. (19) 'Multidrug-resistant Mycobacterium tuberculosis' means a laboratory culture or subculture of Mycobacterium tuberculosiswhich is determined by antimicrobial susceptibility testing to be resistant to at least isoniazid and rifampin. (20) 'Outbreak' means the occurrence of cases of a disease (illness) above the expected or baseline level, usually over a given period of time, in a geographic area or facility, or in a specific population group. The number of cases indicating the presence of an outbreak will vary according to the disease agent, size and type of population exposed, previous exposure to the agent, and the time and place of occurrence. Thus, the designation of an outbreak is relative to the usual frequency of the disease in the same facility or community, among the specified population, over a comparable period of time. A single case of a communicable disease long absent from a population or the first invasion by a disease not previously recognized requires immediate reporting and epidemiologic investigation. (21) 'Personal information' means any information that identifies or describes a person, including, but not limited to, his or her name, social security number, date of birth, physical description, home address, home telephone number, and medical or employment history. (22) 'Sexually Transmitted Diseases' means Chancroid, Lymphogranuloma Venereum, Granuloma Inguinale, Syphilis, Gonorrhea, Chlamydia, Pelvic Inflammatory Disease, and Nongonococcal Urethritis. (23) 'Suspected case' means (A) a person whom a health care provider believes, after weighing signs, symptoms, and/or laboratory evidence, to probably have a particular disease or condition listed in subsection (j); or (B) a person who is considered a probable case, or an epidemiologically-linked case, or who has supportive laboratory findings under the most recent communicable disease surveillance case definition established by CDC and published in the Morbidity and Mortality Weekly Report (MMWR) or its supplements; or (C) an animal which has been determined by a veterinarian to exhibit clinical signs or which has laboratory findings suggestive of rabies or plague. (24) 'Unusual disease' means a rare disease or a newly apparent or emerging disease or syndrome of uncertain etiology which a health care provider has reason to believe could possibly be caused by a transmissible infectious agent or microbial toxin. (25) 'Water-associated disease' means an illness in which there is evidence to suggest that the illness could possibly have resulted from physical contact with or swallowing water from a microbiologically or chemically contaminated source. Examples of such potentially contaminated water sources are lakes, rivers, streams, irrigation water, wells, public and private drinking water, bottled water, reclaimed water, ocean and bay waters, hot springs, hot tubs, whirlpool spas, and swimming pools. Epidemiologic investigation by public health authorities is required to demonstrate that a suspected water-associated illness was likely to have been waterborne and related to the suspected source. (26) 'Waterborne disease outbreak' means an incident in which two or more persons experienced a similar illness after consumption or use of the same water intended for drinking or after water contact such as by immersion, and epidemiologic investigation by public health authorities implicates the same water as the source of the waterborne illness. There is one exception: a single case of waterborne chemical poisoning constitutes an outbreak if laboratory studies indicate that the source water is contaminated by the chemical. (b) It shall be the duty of every health care provider, knowing of or in attendance on a case or suspected case of any of the diseases or conditions listed in subsection (j) of this section, to report to the local health officer for the jurisdiction where the patient resides as required in subsection (h) of this section. Where no health care provider is in attendance, any individual having knowledge of a person who is suspected to be suffering from one of the diseases or conditions listed in subsection (j) of this section may make such a report to the local health officer for the jurisdiction where the patient resides. (c) The administrator of each health facility, clinic or other setting where more than one health care provider may know of a case, a suspected case or an outbreak of disease within the facility shall establish and be responsible for administrative procedures to assure that reports are made to the local health officer. (d) Each report made pursuant to subsection (b) shall include all of the following information if known: (1) name of the disease or condition being reported; the date of onset; the date of diagnosis; the name, address, telephone number, occupation, race/ethnic group, Social Security number, sex, age, and date of birth for the case or suspected case; the date of death if death has occurred; and the name, address and telephone number of the person making the report. (2) If the disease reported pursuant to subsection (b) is hepatitis, a sexually transmitted disease or tuberculosis, then the report shall include the following applicable information, if known: (A) hepatitis information as to the type of hepatitis, type-specific laboratory findings, and sources of exposure, (B) sexually transmitted disease information as to the specific causative agent, syphilis-specific laboratory findings, and any complications of gonorrhea or chlamydia infections, or (C) tuberculosis information on the diagnostic status of the case or suspected case, bacteriologic, radiologic and tuberculin skin test findings, information regarding the risk of transmission of the disease to other persons, and a list of the anti-tuberculosis medications administered to the patient. (e) Confidential Morbidity Report forms, PM 110 (1/90), are available from the local health department for reporting as required by this section. (f) Information reported pursuant to this section is acquired in confidence and shall not be disclosed by the local health officer except as authorized by these regulations, as required by state or federal law, or with the written consent of the individual to whom the information pertains or the legal representative of the individual. (g) Upon the Department of Health Services' request, a local health department shall provide to the Department the information reported pursuant to this section. Absent the individual's written consent, no information that would directly or indirectly identify the case or suspected case as an individual who has applied for or been given services for alcohol or other drug abuse by a federally assisted drug or alcohol abuse treatment program (as defined in federal law at 42 C.F.R. Section 2.11) shall be included. (h) The urgency of reporting is identified by symbols in the list of diseases and conditions in subsection (j) of this section. Those diseases with a diamond (r) are considered emergencies and shall be reported immediately by telephone. Those diseases and conditions with a cross (+) shall be reported by mailing, telephoning or electronically transmitting a report within one (1) working day of identification of the case or suspected case. Those diseases and conditions not otherwise identified by a diamond or a cross shall be reported by mailing a written report, telephoning, or electronically transmitting a report within seven (7) calendar days of the time of identification. (i) For foodborne disease, the bullet (w) symbol indicates that, when two (2) or more cases or suspected cases of foodborne disease from separate households are suspected to have the same source of illness, they shall be reported immediately by telephone. (j) Health care providers shall submit reports for the following diseases or conditions. Acquired Immune Deficiency Syndrome (AIDS) + Amebiasis + Anisakiasis r Anthrax + Babesiosis r Botulism (Infant, Foodborne, Wound, Other) r Brucellosis + Campylobacteriosis Chancroid Chlamydial Infections r Cholera r Ciguatera Fish Poisoning Coccidioidomycosis + Colorado Tick Fever + Conjunctivitis, Acute Infectious of the Newborn, Specify Etiology + Cryptosporidiosis Cysticercosis r Dengue r Diarrhea of the Newborn, Outbreaks r Diphtheria r Domoic Acid Poisoning (Amnesic Shellfish Poisoning) Echinococcosis (Hydatid Disease) Ehrlichiosis + Encephalitis, Specify Etiology: Viral, Bacterial, Fungal, Parasitic r Escherichia coli O157:H7 Infection +w Foodborne Disease Giardiasis Gonococcal Infections + Haemophilus influenzae, Invasive Disease r Hantavirus Infections r Hemolytic Uremic Syndrome Hepatitis, Viral + Hepatitis A Hepatitis B (specify acute case or chronic) Hepatitis, C (specify acute case or chronic) Hepatitis D (Delta) Hepatitis, other, acute Kawasaki Syndrome (Mucocutaneous Lymph Node Syndrome) Legionellosis Leprosy (Hansen Disease) Leptospirosis + Listeriosis Lyme Disease + Lymphocytic Choriomeningitis + Malaria + Measles (Rubeola) + Meningitis, Specify Etiology: Viral, Bacterial, Fungal, Parasitic r Meningococcal Infections Mumps Non-Gonococcal Urethritis (Excluding Laboratory Confirmed Chlamydial Infections r Paralytic Shellfish Poisoning Pelvic Inflammatory Disease (PID) + Pertussis (Whooping Cough) r Plague, Human or Animal + Poliomyelitis, Paralytic + Psittacosis + Q Fever r Rabies, Human or Animal + Relapsing Fever Reye Syndrome Rheumatic Fever, Acute Rocky Mountain Spotted Fever Rubella (German Measles) Rubella Syndrome, Congenital + Salmonellosis (Other than Typhoid Fever) r Scombroid Fish Polsoning r Severe Acute Respiratory Infection (SARS) + Shigellosis r Smallpox (Variola) + Streptococcal Infections (Outbreaks of Any Type and Individual Cases in Food Handlers and Dairy Workers Only) + Swimmer's Itch (Schistosomal Dermatitis) + Syphilis Tetanus Toxic Shock Syndrome Toxoplasmosis + Trichinosis + Tuberculosis r Tularemia + Typhoid Fever, Cases and Carriers Typhus Fever r Varicella (deaths only) + Vibrio Infections r Viral Hemorrhagic Fevers (e.g., Crimean-Congo, Ebola, Lassa and Marburg viruses) + Water-associated Disease + West Nile virus infection r Yellow Fever + Yersiniosis r OCCURRENCE of ANY UNUSUAL DISEASE r OUTBREAKS of ANY DISEASE (Including diseases not listed in Section 2500). Specify if institutional and/or open community. ---------- (r) = to be reported immediately by telephone. (+) = to be reported by mailing a report, telephoning, or electronically transmitting a report within one (1) working day of identification of the case or suspected case. (No diamond or cross symbol) = to be reported within seven (7) calendar days by mail, telephone, or electronic report from the time of identification. (w) = when two (2) or more cases or suspected cases of foodborne disease from separate households are suspected to have the same source of illness, they should be reported immediately by telephone. Note: Authority cited: Sections 100180, 100275 and 120130, Health and Safety Code. Reference: Sections 1603.1, 100180, 100325, 103925, 113150, 113155, 120125, 120130, 120140, 120175, 120245 and 120250, Health and Safety Code; Sections 551, 554 and 555, Business and Professions Code; Section 1798.3, Civil Code; 42 U.S.C. Sections 290ee-3 and 290dd-3; 42 C.F.R. Sections 2.11 and 2.12; Cal. Const., art. 1, Section 1; and Section 1040, Evidence Code. s 2501. Investigation of a Reported Case, Unusual Disease, or Outbreak of Disease. (a) Upon receiving a report made pursuant to Section 2500 or 2505, the local health officer shall take whatever steps deemed necessary for the investigation and control of the disease, condition or outbreak reported. If the health officer finds that the nature of the disease and the circumstances of the case, unusual disease, or outbreak warrant such action, the health officer shall make or cause to be made an examination of any person who or animal which has been reported pursuant to Sections 2500 or 2505 in order to verify the diagnosis, or the existence of an unusual disease, or outbreak, make an investigation to determine the source of infection, and take appropriate steps to prevent or control the spread of the disease. Whenever requested to do so by the Department, the health officer shall conduct a special morbidity and mortality study under Health and Safety Code Section 211 for any of the diseases made reportable by these regulations. (b) If a disease is one in which the local health officer determines identification of the source of infection is important, and the source of infection is believed to be outside the local jurisdiction, the health officer shall notify the Director or the health officer under whose jurisdiction the infection was probably contracted if known. Similar notification shall be given if there are believed to be exposed persons, living outside the jurisdiction of the health officer, who should be quarantined or evaluated for evidence of the disease. Note: Authority cited: Sections 207, 208 and 3123, Health and Safety Code; and Section 555(b), Business and Professions Code. Reference: Sections 7, 200, 207, 211, 211.5, 304.5, 410, 1603.1, 3051, 3053, 3110, 3122, 3123, 3124, 3125, 3131 and 3132, Health and Safety Code; Sections 551, 554 and 555, Business and Professions Code. s 2502. Reports by Local Health Officer to State Department of Health Services. (a) Summary Reports: Each local health officer shall report at least weekly, on the Weekly Morbidity by Place of Report form (DHS 8245 (11/95)) to the Director the number of cases of those diseases, conditions, unusual diseases or outbreaks of disease reported pursuant to Section 2500. Copies of the form are available from the Department's Division of Communicable Disease Control. (b) Individual Case and Outbreak Reports: For the diseases listed below, the local health officer shall prepare and send to the Department along with the summary report described in (a) above an individual case or outbreak report for each individual case/outbreak of those diseases which the Department has identified as requiring epidemiological analysis reported pursuant to Section 2500. At the discretion of the Director, the required individual case/outbreak report may be either a Confidential Morbidity Report (PM-110 1/90), its electronic equivalent or a hard copy 8.5x11 inch individual case/outbreak report form. The Weekly Morbidity by Place of Report form (DHS 8245 11/95)) indicates which format to use. Each individual case report shall include the following: (1) verification of information reported pursuant to Section 2500; (2) information on the probable source of infection, if known; (3) laboratory or radiologic findings, if any; (4) clinical signs and/or symptoms, if applicable; and (5) any known epidemiological risk factors. The Department or CDC has prepared forms that may be used for many of the diseases requiring individual case reports. Where a form exists, its identification number is listed in parentheses next to the diseases listed below. Copies of these case report forms are available from the Department's Division of Communicable Disease Control. An individual case report is required for the following diseases: Acquired Immune Deficiency Syndrome (AIDS) (CDC 50.42B) Anthrax (ACD-152) Botulism (Infant, Foodborne, Wound, Other) (ACD-153) Brucellosis (262-101) Cholera (CDC 52.79) Cysticercosis (pending) Diarrhea of the Newborn, Outbreaks (262-504) Diptheria (262-505) Escherichia coliO157:H7 Infection (pending) Foodborne Disease Outbreak (CDC 52.13) Haemophilus influenzae, Invasive Disease (DHS 8449) Hantavirus Infections (pending) Hemolytic Uremic Syndrome (pending) Hepatitis A (CDC 53.1) Hepatitis B, acute only (CDC 53.1) Hepatitis C, acute only (CDC 53.1) Hepatitis D (Delta), acute only (CDC 53.1) Hepatitis, any other acute viral type (CDC 53.1) Kawasaki Syndrome (Mucocutaneous Lymph Node Syndrome) (DHS 8468) Legionellosis (CDC 52.56) Leprosy (Hansen Disease) (CDC 52.18) Leptospirosis (262-102) Listeriosis (DHS 8296) Lyme Disease (DHS 8470) Malaria (CDC 54.1) Measles (Rubeola) (DHS 8345) Meningoccal Infections (DHS 8469) Outbreak of Disease Report (DHS 262-501) Pelvic Inflammatory Disease (PID) Pertussis (Whooping Cough) (DHS 8258) Plague (CDC 56.37) Poliomyelitis, Paralytic (DHS 8421) Psittacosis (8023-005) Q Fever (262-101) Rabies, Human or Animal (Humans 262-105, Animals PM 102) Relapsing Fever (262-107) Reye Syndrome (CDC 55.8) Rocky Mountain Spotted Fever (CDC 55.1) Rubella (German Measles) (PM 358; for Congenital Rubella, CDC 71.17) Severe Acute Respiratory Infection (SARS) (pending) Smallpox (pending) Streptococcal Outbreaks and Individual Cases in Food Handlers and Dairy Workers Only Syphilis (for Congenital Syphilis, CDC 73.126) Tetanus (CDC 71.15) Toxic Shock Syndrome (CDC 52.3) Trichinosis (CDC 54.7) Tuberculosis (CDC 72.9 A, B, and C) Tularemia (262-101) Typhoid Fever, Cases and Carriers (Cases, CDC 52.5; Carriers, CDC 4.383) Typhus Fever (262-107) Unusual Disease Report (DHS 262-501) Varicella, Deaths Only (pending) VibrioInfections (CDC 52.79) Viral Hemorrhagic Fevers (pending) Waterborne Disease Outbreak (CDC 52.12) West Nile virus infection (pending) Yellow Fever (c) Immediate Reports: Cases and suspect cases of anthrax, botulism, brucellosis, cholera, dengue, diarrhea of the newborn (outbreaks), diphtheria, plague, rabies (human only), smallpox (varoila), tularemia, varicella deaths, viral hemorrhagic fevers, yellow fever, occurrence of any unusual diseases, and outbreaks of any disease are to be reported by the local health officer to the Director immediately by telephone. (d) Upon request of the Department, the local health officer shall submit an individual case report for any disease not listed in subsection (b) above. (e) During any special morbidity and mortality study requested under Section 2501, the local health officer shall be the Director's agent for purposes of carrying out the powers conferred under Government Code Section 11181. (f) Confidentiality. Information reported pursuant to this section is acquired in confidence and shall not be disclosed by the local health officer except as authorized by these regulations, as required by state or federal law, or with the written consent of the individual to whom the information pertains or to the legal representative of that individual. (1) A health officer shall disclose any information, including personal information, contained in an individual case report to state, federal or local public health officials in order to determine the existence of a disease, its likely cause or the measures necessary to stop its spread. (2) A health officer may for purposes of his or her investigation disclose any information contained in an individual case report, including personal information, as may be necessary to prevent the spread of disease or occurrence of additional cases. (3) A health officer may disclose any information contained in an individual case report to any person or entity if the disclosure may occur without linking the information disclosed to the individual to whom it pertains, and the purpose of the disclosure is to increase understanding of disease patterns, to develop prevention and control programs, to communicate new knowledge about a disease to the community, or for research. (4) Notwithstanding subsections (1), (2), and (3) above, no information that would directly or indirectly identify an individual as one who has applied for or been given services for alcohol or other drug abuse by a federally assisted drug or alcohol abuse treatment program (as defined in 42 C.F.R. s 2.11) shall be included in an individual case report or otherwise disclosed absent the individual's written consent. (g) Whenever the health officer collects personal information in order to prepare an individual case report required by subsection (b), the health officer shall notify the individual from whom the information is collected that: (1) supplying personal information related to the individual's disease is mandatory; (2) the only disclosure of personal information will be pursuant to subsections 2502(f(1) and 2502(f)(2); and (3) non-personal information may be disclosed pursuant to subsection 2502(f)(3). Note: Authority cited: Sections 100180, 100275 and 120130, Health and Safety Code; and Section 555(b), Business and Professions Code. Reference: Sections 7, 1603.1, 100180, 100325, 100330, 103925, 113150, 113155, 120125, 120130, 120140, 120145, 120175, 120190, 120245 and 120250, Health and Safety Code; and Sections 551, 554 and 555, Business and Professions Code; Sections 11181 and 11182, Government Code; 42 U.S.C. sections 290ee-3 and 290dd-3; 42 C.F.R. Sections 2.11 and 2.12.; Cal. Const., art. 1, Section 1; Section 1040, Evidence Code; and Section 1798.3, Civil Code. s 2503. Reporting Occurrence of Unusual Diseases. Note: Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 200, 207, 3053, 3110, 3123, 3124 and 3125, Health and Safety Code. s 2504. Report by Health Care Provider of Out-of-State Laboratory Findings. Whenever a health care provider's identification of a case or suspected case of tuberculosis includes laboratory findings from an out-of-state laboratory, the health care provider shall include those findings with the report made pursuant to Section 2500(b), and if the laboratory performed drug susceptibility testing, the results of such testing shall also be so reported. Note: Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 200, 207, 3053, 3110, 3123, 3125 and 3285, Health and Safety Code. s 2505. Notification by Laboratories. (a) To assist the local health officer, the laboratory director, or the laboratory director's designee, of a clinical laboratory, an approved public health laboratory or a veterinary laboratory in which a laboratory examination of any specimen derived from the human body (or from an animal, in the case of rabies or plague testing) yields microscopical, cultural, immunological, serological, or other evidence suggestive of those diseases listed in subsections (e)(1) and (e)(2) below, shall report such findings to the health officer of the local health jurisdiction where the health care provider who first submitted the specimen is located. (1) For those diseases listed in subsection (e)(1), the report of such findings shall be made within one hour after the laboratory notifies the health care provider or other person authorized to receive the report. If the laboratory that makes the positive finding received the specimen from another laboratory, the laboratory making the positive finding shall notify the health officer of the jurisdiction in which the health care provider is located within one hour from the time the laboratory notifies the referring laboratory that submitted the specimen. (2) For those diseases listed in subsection (e)(2), the report of such findings shall be made within one working day from the time that the laboratory notifies the health care provider or other person authorized to receive the report. If the laboratory that makes the positive finding received the specimen from another laboratory, the laboratory making the positive finding shall notify the health officer of the jurisdiction in which the health care provider is located within one working day from the time the laboratory notifies the referring laboratory that submitted the specimen. (b) To permit local health officer follow-up of laboratory findings, all specimens submitted for laboratory tests or examinations related to a disease or condition listed in subsections 2505(e)(1) or 2502(e)(2) shall be accompanied by a test requisition which includes the name, gender, and age or date-of-birth of the person from whom the specimen was obtained and the name, address and telephone number of the health care provider or other authorized person who submitted the specimen. Whenever the specimen, or an isolate therefrom, is transferred between laboratories, a test requisition with the above patient and submitter information shall accompany the specimen. The laboratory that first receives a specimen shall be responsible for obtaining the patient and submitter information at the time the specimen is received by that laboratory. (c) Each notification to the local health officer shall include the date the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the laboratory findings for the test performed, the date that any positive laboratory findings were identified, the name, gender, address, telephone number (if known) and age or date of birth of the person from whom the specimen was obtained, and the name, address, and telephone number of the health care provider for whom such examination or test was performed. (d) The notification shall be submitted as specified in subsections (e)(1) and (e)(2) of this Section to the local health officer in the jurisdiction where the health care provider who submitted the specimen is located. When the specimen is from an out-of-state submitter, the state epidemiologist of the submitter shall be provided the same positive findings per subsections (e)(1) and (e)(2) of this Section. If the laboratory that finds evidence for any of those diseases listed in subsections (e)(1) and (e)(2) is an out-of-state laboratory, the California clinical laboratory that receives a report of such findings from the out-of-state laboratory shall notify the local health officer in the same way as if the finding had been made by the California laboratory. (e) Laboratory reports to the local health officer shall include the information as specified in (c) of this Section and laboratories shall submit the reports within the following timeframes: (1) The diseases specified shall be reported within one hour after the health care provider or other person authorized to receive the report has been notified. Laboratories shall make the initial reports to the local health officer by telephone and follow the initial report within one working day by a report in writing submitted by electronic facsimile transmission or electronic mail to the local health officer. The diseases reported pursuant to this requirement are: Anthrax Botulism Brucellosis, by isolation of Brucellaspecies from a clinical specimen, or demonstration by immunofluorescence of Brucellaspecies in a clinical specimen, or fourfold or greater rise in antibody titer to Brucellaantigen between acute and convalescent phase serum specimens obtained two or more weeks apart and studied at the same laboratory, or elevated serum antibody to Brucellaantigen at a titer of 1:160 or greater in a single serum specimen. Plague, animal or human Smallpox (Variola) Tularemia, by isolation of Francisella tularensisin a clinical specimen, or demonstration by immunofluorescence of F. tularensisin a clinical specimen, or fourfold or greater rise in antibody titers to F. tularensisantigen between acute and convalescent phase serum specimens obtained two or more weeks apart and studied at the same laboratory, or elevated antibody to F. tularensisantigen at a titer of 1:160 or greater in a single serum specimen. Viral Hemorrhagic Fever agents (e.g., Crimean-Congo, Ebola, Lassa, and Marburg viruses) (2) The diseases specified shall be reported within one working day after the health care provider or other person authorized to receive the report has been notified. Laboratories shall transmit these reports to the local health officer by courier, mail, electronic facsimile or electronic mail. The diseases reported pursuant to this requirement are: Borrelia burgdorferiinfection Chlamydial infections Cryptosporidiosis Diphtheria Encephalitis, arboviral Escherichia coliO157:H7 infection Gonorrhea Hepatitis A, acute infection, by lgM anitbody test or positive viral antigen test Hepatitis B, acute infection, by lgM anti-HBc anitbody test Hepatitis B surface antigen positively (specify gender) Listeriosis Malaria Measles (Rubeola), acute infection, by lgM anitbody test or positive viral antigen test Rabies, animal or human Syphilis Tuberculosis Typhoid Vibriospecies infections West Nile virus infection (f) In addition to notifying the local health officer pursuant to subsection (a), any clinical laboratory or approved public health laboratory that isolates Mycobacterium tuberculosisfrom a patient specimen shall: (1) submit a culture as soon as available from the primary isolate on which a diagnosis of tuberculosis was established. Such a culture shall be submitted to the public health laboratory designated in Title 17 California Code of Regulations, Section 1075 for the local jurisdiction where the health care provider's office is located. The following information shall be submitted with the culture: the name, address, and the date of birth of the person from whom the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the date the specimen was obtained from the patient, and the name, address, and telephone number of the health care provider for whom such examination or test was performed. The public health laboratory shall retain the culture received (one culture from each culture-positive patient) in a viable condition for at least six months. (2) Unless drug susceptibility testing has been performed by the clinical laboratory on a strain obtained from the same patient within the previous three months or the health care provider who submitted the specimen for laboratory examination informs the laboratory that such drug susceptibility testing has been performed by another laboratory on a culture obtained from that patient within the previous three months, the clinical laboratory shall: (A) perform or refer for drug susceptibility testing on at least one isolate from each patient from whom Mycobacterium tuberculosiswas isolated; and (B) report the results of drug susceptibility testing to the local health officer of the city or county where the submitting physician's office is located within one working day from the time the health care provider or other authorized person who submitted the specimen is notified; and (C) If the drug susceptibility testing determines the culture to be resistant to at least isoniazid and rifampin, in addition, submit one culture or subculture from each patient from whom multidrug-resistant Mycobacterium tuberculosiswas isolated to the official public health laboratory designated in Title 17 California Code of Regulations Section 1075 for the local health jurisdiction in which the health care provider's office is located. The local public health laboratory shall forward such cultures to the Department's Microbial Diseases Laboratory. The following information shall be submitted with the culture: the name, address, and the date of birth of the person from whom the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the date the specimen was obtained from the patient, and the name, address, and telephone number of the health care provider for whom such examination or test was performed. (g) Whenever a clinical laboratory finds that a specimen from a patient with known or suspected tuberculosis tests positive for acid fast bacillus (AFB) staining and the patient has not had a culture which identifies that acid fast organism within the past 30 days, the clinical laboratory shall culture and identify the acid fast bacteria or refer a subculture to another laboratory for those purposes. (h) In addition to notifying the local health officer pursuant to subsection (a), any clinical laboratory that makes a finding of malaria parasites in the blood film of a patient shall immediately submit one or more such blood film slides for confirmation to the public health laboratory designated in Title 17 California Code of Regulations Section 1075 for the local health jurisdiction where the health care provider is located. When requested, all blood films shall be returned to the submitter. (i) All laboratory notifications herein required are acquired in confidence and shall not be disclosed by the local health officer except (1) as authorized by these regulations; (2) as required by state or federal law; or (3) with the written consent of the individual to whom the information pertains or the legal representative of that individual. (j) The local health officer shall disclose any information, including personal information, contained in a laboratory notification to state, federal or local public health officials in order to determine the existence of the disease, its likely cause and the measures necessary to stop its spread. Note: Authority cited: Sections 100180, 100275, 120130 and 125095, Health and Safety Code. Reference: Sections 100180, 120125, 120130, 120140, 120175, 120575, 121365 and 125100, Health and Safety Code; Sections 1209, 1246.5 and 1288, Business and Professions Code; Cal. Const., art. 1, Section 1; and Section 1040, Evidence Code. s 2508. Reporting by Schools. It shall be the duty of anyone in charge of a public or private school, kindergarten, boarding school, or day nursery to report at once to the local health officer the presence or suspected presence of any of the communicable diseases. s 2509. Records of Local Health Officer. The local health officer shall maintain such records as he deems necessary in the performance of his duties, or as requested by the State Department of Health Services. s 2510. Outbreaks of Nonreportable Diseases. s 2511. Determination of Morbidity Level. It shall be the duty of the local health officer to determine the amount and kind of communicable disease occurring in his area by such methods as he deems necessary in order to obtain knowledge of the general level of morbidity in his jurisdiction. s 2512. Investigation of the Case. s 2514. Instructions to Household. It shall be the duty of the health care provider in attendance on a case or suspected case of any disease or condition listed in Sections 2500, or of any other disease considered to be communicable, to give detailed instructions to the members of the household in regard to precautionary measures to be taken for preventing the spread of the disease or condition. Such instructions shall conform to these regulations and local ordinances. It is the responsibility of each health care provider to be informed as to these regulations and the local ordinances which are in effect in the communities in which the health care provider practices. Note: Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 207, 208, 3123 and 3285, Health and Safety Code. s 2515. Definition of Isolation. Isolation is defined as separation of infected persons from other persons for the period of communicability in such places and under such conditions as will prevent the transmission of the infectious agent. Isolation will be applied as instructed below. s 2516. Strict Isolation. If the disease is one requiring strict isolation, the health officer shall insure that instructions are given to the patient and members of the household, defining the area within which the patient is to be isolated and stating the measures to be taken to prevent the spread of the disease. Strict isolation shall include the following measures: (a) The patient shall have a separate bed in a room protected against flies. (b) All persons, except those caring for the patient, shall be excluded from the sick room. (c) The persons caring for the patient shall avoid coming in contact with any other persons within the household or elsewhere until every precaution has been taken to prevent the spread of infectious material from the patient's room. (d) The persons caring for the patient shall wear a washable outer garment and shall thoroughly wash their hands with soap and hot water after handling the patient or any object he may have contaminated. On leaving the room in which the patient is isolated, the attendant shall take off the washable outer garment and hang it in the room until disinfected. (e) All discharges from the nose and mouth shall be burned or disinfected. The discharges should be received in pieces of soft tissue or cloth and dropped into a paper bag which can be burned. (f) Objects which may have been contaminated by the patient shall be thoroughly cleansed before being removed from the contaminated area. (g) The feces and urine of patients suffering from diseases in which the infectious agent appears in the feces or urine shall be disposed of according to instructions given be the local health officer. s 2518. Modified Isolation. If the disease is one in which only a modified isolation is required, the local health officer shall issue appropriate instructions, prescribing the isolation technique to be followed. The isolation technique will depend upon the disease. s 2520. Quarantine. Quarantine is defined as the limitation of freedom of movement of persons or animals that have been exposed to a communicable disease for a period of time equal to the longest usual incubation period of the disease, in such manner as to prevent effective contact with those not so exposed. If the disease is one requiring quarantine of the contacts in addition to isolation of the case, the local health officer shall determine the contacts who are subject to quarantine, specify the place to which they shall be quarantined, and issue instructions accordingly. He shall insure that provisions are made for the medical observation of such contacts as frequently as necessary during the quarantine period. s 2522. Observation. For the purposes of definition, the term "observation," as used in these regulations, shall refer to a frequent check upon the person under observation to determine whether such person is free of the disease for which he has been placed under observation, or has contracted the disease. Unless otherwise specified, it does not mean the isolation or quarantine of the individual. s 2524. Terminal Disinfection. Each person released from quarantine or isolation shall bathe and wash his hair with soap and hot water and put on clean clothes. The area of isolation shall be disinfected according to the instructions of the local health officer. s 2526. Exclusion and Readmission by School Authorities. It shall be the duty of the principal or other person in charge of any public, private or Sunday School to exclude therefrom any child or other person affected with a disease presumably communicable, until the expiration of the prescribed period of isolation for the particular communicable disease. If the attending physician, school physician, or health officer finds upon examination that the person is not suffering from a communicable disease, he may submit a certificate to this effect to the school authority who shall readmit the person. Note: Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 200, 207, 3051, 3053, 3110, 3118 and 3123, Health and Safety Code. s 2528. Contamination by Pathogenic Organisms of Milk, Milk Products or Products Resembling Milk Products. (a) The State Department of Health Services finds that the presence of any of the following pathogenic organisms in milk, milk product, or product resembling milk products make such product unsafe for human consumption: Mycobacterium tuberculosis; Brucella spp.; Streptococcus pyogenes, group A hemolytic; Corynebacterium diphtheria; Salmonella paratyphi; Salmonella schottmuelleri; Salmonella hirschfeldi; Salmonella typhi; Salmoneela dublin; Salmonella typhimurium; Shigella spp. Whenever a health officer finds that milk, milk product, or product resembling milk products, is unsafe for human consumption because it contains any of the above named organisms, he shall issue a written order to the producer or distributor of the product (1) summarizing the laboratory findings, and (2) prohibiting the sale or disposal of such milk, milk product, or product resembling milk products, except by a method approved by him, until such time as he finds the product or products to be safe for human consumption. (b) Whenever a health officer has evidence that milk, milk product, or product resembling milk products has caused human illness or contains toxins which make such product unsafe for human consumption, he may issue a written order to the producer or distributor of the product (1) stating the facts upon which his conclusions are based, and (2) prohibiting the use, sale, or disposal of such milk, milk product, or product resembling milk products, except by a method approved by him, until such time as he finds it to be safe for human consumption. (c) The health officer shall immediately forward a copy of any order issued pursuant to this section to the State Director of Health Services. (d) Any producer or distributor of milk, milk product, or product resembling milk products, subject to an order of a health officer pursuant to this section may appeal to the State Department of Health Services solely upon the question of whether such products are, in fact, safe for human consumption. Such appeal shall be made in writing, stating which of the facts set forth in the order are admitted and denied. Upon receipt of the written appeal, the State Director of Health Services, after such investigation of the matter as he deems necessary, may amend or rescind the order, or set the matter for hearing before a hearing officer designated by him. In the event the order is not rescinded or amended to the satisfaction of the appellant, the matter shall be set for hearing. The hearing shall, if possible, be set within 14 days from the date of receipt of the appeal, unless additional time is required by the appellant. Insofar as is practicable, the procedures of the Administrative Procedure Act (Ch. 5, Pt. 1, Div. 3, Title 2, of the Government Code) shall apply. The hearing officer shall submit a proposed decision to the State Department of Health Services which shall issue its decision in accordance with Section 11517 of the Administrative Procedure Act. The decision shall be subject to judicial review. (e) The procedures of this section authorize a health officer to take immediate action to protect the public health in the event he finds that milk, milk products, or products resembling milk products constitutes the applicability of other provisions of law pertaining to the regulation of such products, including but not limited to, the provisions of the Agricultural Code and the California Pure Foods Act (Ch. 3, Div. 21, Health and Safety Code). Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 3110-3125, Health and Safety Code. s 2530. Public Food Handlers. No person known to be infected with a communicable disease or suspected of being infected with a communicable disease shall engage in the commercial handling of food, or be employed on a dairy or on premises handling milk or milk products, until he is determined by the health officer to be free of such disease, or incapable of transmitting the infection. (See Chapter 7, Article 1, Section 28295, Health and Safety Code.) Note: Authority cited: Sections 207, 208 and 3123, Health and Safety Code. Reference: Sections 200, 207, 3051, 3053, 3110, 3123, 3131, 3132 and 28295, Health and Safety Code s 2534. Laboratory Tests for the Release of Cases of Carriers of Communicable Diseases. Whenever laboratory tests are required for the release of cases or carriers, the tests shall be taken by the health officer or his representatives and shall be submitted to a public health officer or his representatives and shall be submitted to a public health laboratory approved by the State Department of Health Services. Specimens may be sent to laboratories not so approved, provided the specimens are divided and a portion of the specimens are sent to an approved laboratory. Release shall be considered on the basis of the report of the approved laboratory only. s 2536. Transportation of Communicable Disease Cases. No person with a communicable disease subject to isolation not any contact subject to quarantine shall travel or be transported from one place to another within the local health jurisdiction, without the permissions of the local health officer, and no such person shall travel or be transported outside the area of jurisdiction of the health officer until the permission of the health officer into whose jurisdiction the patient is to be brought is obtained. An exception may be made in instances where the patient is to be admitted directly to a hospital for the treatment of the communicable disease,provided that the health officer from whose jurisdiction the case to be transported shall insure that adequate precautions are taken to prevent dissemination of the disease by the patient or his contacts en route to the hospital. s 2538. Funerals. Funeral services for individuals who have died of a communicable disease shall be conducted in accordance with instructions of the health officer. In diseases requiring quarantine of contacts, a public funeral service may be permitted only if the casket remains closed and those contacts subject to quarantine who attend the funeral are adequately segregated from the public. s 2540. General Clause. In addition to the requirements stipulated in these regulations, the local health officer shall, after suitable investigation, take such additional steps as he deems necessary to prevent the spread of communicable disease or a disease suspected of being communicable in order to protect the public health. s 2550. Amebiasis. (a) Under ordinary circumstances, isolation of cases and quarantine of contacts are not required. (b) Persons who are found to be excreting Endamoeba histolytica in the feces shall be prohibited from public food handling until three feces specimens, taken at intervals of not less than three days, shall be proved negative for the organism by a public health laboratory approved by the State Department of Health Services. s 2551. Anthrax. Cases and Suspect Cases to Be Reported by Telephone. (See Section 2502(c).) (a) Patient. The patient shall be isolated in accordance with Section 2518. Wound isolation precautions shall be instituted until lesions are free of anthrax bacilli. There are no restrictions on contacts. (b) Laboratory. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human anthrax, such laboratory shall communicate immediately by telephone with the Microbial Diseases Laboratory of the State Department of Health Services for instruction. Note: Authority cited: Sections 100180, 100275, 120130 and 120145, Health and Safety Code. Reference: Sections 120130, 120175, 120190, 120195 and 120215, Health and Safety Code. s 2552. Botulism. Cases and Suspect Cases to Be Reported by Telephone. (See Section 2502(c).) The health officer shall make an immediate investigation of every case or suspected case of botulism in an effort to establish the diagnosis and determine the source. In the event that a commercial food product is suspected as the source, special instructions will be given by the State Department of Health Services. The local health officer shall take all necessary steps to prevent distribution and consumption of the suspected food. There are no restrictions on case or contacts. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human botulism, such laboratory shall communicate immediately by telephone with the Microbial Diseases Laboratory of the Department of Health Services for instruction. Note: Authority cited: Sections 100180, 100275 and 120130, Health and Safety Code. Reference: Sections 100180, 100275, 120175, 120185 and 120190, Health and Safety Code. s 2553. Brucellosis (Undulant Fever). Cases and Suspect Cases to Be Reported by Telephone. (See Section 2502(c).) There are no restrictions on case or contacts. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human brucellosis, such laboratory shall communicate immediately by telephone with the Microbial Diseases Laboratory of the Department of Health Services for instruction. Note: Authority cited: Sections 100180, 100275 and 120130, Health and Safety Code. Reference: Sections 100180, 100275, 120185 and 120190, Health and Safety Code. s 2554. Chancroid. (See Section 2636 on Venereal Diseases.) s 2555. Chickenpox. s 2556. Cholera. Cases and Suspect Cases to Be Reported by Telephone or Telegraph. (See Section 2501(c).) The case shall be isolated in accordance with Section 2516 and the intimate contacts quarantined pending receipt of instructions from the State Health Services Department. s 2558. Coccidioidomycosis. Report active cases only primary (including cavitary) or disseminated. There are no restrictions on case or contacts. s 2560. Conjunctivitis, Acute Infectious of the Newborn. (a) Acute infectious conjunctivitis of the newborn includes gonorrheal ophthalmia and ophthalmia neonatorum. (b) Prophylaxis for acute infectious conjunctivitis of the newborn shall be administered to all infants within two hours after birth in accordance with Sections 551-556 of the Business and Professions Code. (c) The approved prophylaxis for acute infectious conjunctivitis of the newborn shall be any one of the following. (1) One percent silver nitrate in wax ampules administered without saline irrigation. (2) Ophthalmic ointments or drops containing tetracycline or erythromycin. (d) An infant with acute infectious conjunctivitis shall be isolated in accordance with Section 2516, Title 17, California Administrative Code, until clinical recovery occurs and negative laboratory tests are obtained. Note: Authority cited: Section 555(b), Business and Professions Code. Reference: Sections 551 through 556, Business and Professions Code. s 2562. Dengue. Cases and Suspect Cases to Be Reported by Telephone or Telegraph. (See Section 2501(c).) The case shall be confined during the clinical phase of the disease in a room or dwelling satisfactorily protected against mosquitos. There are no restrictions on contacts. s 2564. Diarrhea of the Newborn. (a) Any infant under 1 month of age in a hospital or institution, or any infant hospitalized because of prematurity, who has two or more watery or otherwise apparently abnormal stools within a 24-hour period, with or without other signs of illness, shall be considered a suspicious case of diarrhea of the newborn and immediately isolated. Any newborn, who within four days after discharge from a hospital has two or more watery or otherwise apparently abnormal stools within a 24-hour period, with or without other signs of illness, shall be considered a suspicious case and kept under close observation. If the diarrhea continues for more than two days the infant shall be immediately reported as a case of diarrhea of the newborn to the local health officer by telephone or other equally prompt means. An exception may be made in the case of entirely breastfed infants who show no signs of illness and are gaining weight. (b) Isolation of Case. The case shall be placed in strict isolation until discharged from the hospital. (c) Quarantine of Infants in Nursery. If two or more cases occur, all infants in the nursery shall be quarantined and no infants shall be admitted until all exposed infants have been discharged and the nursery thoroughly cleaned, and personnel, equipment, and procedures involved have been investigated by the health officer and found adequate. (d) Care of Noncontacts. Infants born subsequent to quarantine of infants in the newborn nursery for diarrhea of the newborn shall be cared for in a separate clean newborn nursery by a separate nursing staff. (e) Closure of Hospital to Maternity Admissions. If cases of diarrhea of the newborn as defined above occur also in the temporary clean nursery, the hospital shall be closed to maternity admissions until all cases and contacts are discharged and all nursery rooms and equipment thoroughly cleaned. s 2566. Diphtheria. (a) Isolation of Patient. The patient shall be isolated in accordance with Section 2516 until 2 cultures from the throat and 2 from the nose, taken not less than 24 hours apart, fail to show the presence of diphtheria bacilli, except that upon clinical recovery and where antibiotics have been used as therapy, isolation may be modified in accordance with Section 2518. Release cultures may not be taken less than seven days after discontinuance of such therapy. Isolation may be terminated if the bacilli cultured from the case are proved to be virulent. (b) Control of Household Contacts. All household contacts shall be kept under daily medical observation for clinical evidence of diphtheria for seven days after last exposure. These contacts shall be isolated if they are found to have sore throat or nasal discharge until proved by culture not to have diphtheria. All household contacts under the age of 15 shall be quarantined for at least seven days after the last exposure to the case. Nose and throat cultures for diphtheria should then be taken and the contacts may be released from quarantine if such cultures are negative. If the contact has received an antibiotic, release cultures may not be taken less than seven days after discontinuation of such medication. (c) Release of Carriers From Isolation. Convalescent or healthy carriers of diphtheria bacilli may be released from quarantine if the bacilli are shown to be avirulent by appropriate laboratory tests. Any person who has been free from the symptoms of diphtheria for four weeks or longer and who harbors virulent diphtheria bacilli is defined as a chronic carrier. Efforts should be made to eliminate the carrier state in such persons by appropriate medical or surgical measures. If these measures are unsuccessful or are refused the health officer may release the carrier from isolation when, in his judgment, such release is not detrimental to the public health, except that the carrier may not be permitted to engage in any occupation which involves handling of foods of close association with children outside his own family. (d) Laboratory Tests for the Release of Cases or Carriers. Cultures or virulence tests for the release of diphtheria cases or carriers shall be taken not less than seven days after discontinuation of antibiotic therapy and examined in accordance with the provisions of Section 2534. (e) Cases on Dairies. When a case of diphtheria occurs or is confined on the premises where milk or milk products are handled, the health officer shall prohibit the use, sale or disposal of such milk or milk product, except by a method approved by him, until he is satisfied that such products are safe for human consumption. (f) Immunization. The health officer shall take appropriate measures to encourage and facilitate a continuing program of active immunization against diphtheria for all children within his jurisdiction. s 2570. Encephalitis, Acute (Including Arthropod-Borne Viral, Post-Infectious, and Others). The patient shall be isolated in accordance with Section 2518 for seven days from the onset of the infection. There are no restrictions on contacts. s 2572. Disorders Characterized by Lapses of Consciousness, Alzheimer's Disease and Related Disorders. Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code. s 2574. Food Poisoning. (Excluding Botulism and Salmonella infections). A reportable case of food poisoning is defined as follows: any person with symptoms of acute gastroenteritis, vomiting, diarrhea, or neurologic symptoms whose illness occurs in association with a group of other persons who may have consumed a common food or beverage. The etiologic agents include: (a) Organic poisons present in normal animal or plant tissues, including mushrooms, fish, and mussels. (b) Mineral or organic poisons, including arsenic, lead, cadmium, and fluorine, introduced into food by accident, or with the intent to improve the appearance or as preservatives. (c) Toxins preformed in food by the growth of microorganisms, including staphylococci. (Botulism is reported separately. See Section 2552.) Upon receiving the report, the health officer shall make or cause to be made an investigation in an effort to determine the source and cause of the outbreak. If the responsible food is one distributed outside the area over which he has jurisdiction, he shall immediately report his findings to the Director of the State Department of Health Services and to those local health officers concerned. There are no restrictions on cases or contacts. s 2575. German Measles (Rubella). The patient shall be isolated in accordance with Section 2518 until clinically recovered. There are no restrictions on contacts. s 2577. Gonococcus Infection. (See Section 2636 on Venereal Diseases.) s 2578. Granuloma Inguinale. (See Section 2636 on Venereal Diseases.) s 2579. Hepatitis, Infectious. (This term includes cases diagnosed as acute catarrhal jaundice, epidemic hepatitis and epidemic jaundice.) The patient shall be isolated in accordance with Section 2518 during the acute symptoms. There are no restrictions on contacts. s 2580. Influenza, Epidemic. s 2581. Hepatitis, Serum (Homologous Serum Jaundice). The patient shall be isolated in accordance with Section 2518 during the acute symptoms. There are no restrictions on contacts. s 2582. Leprosy (Hansen's Disease). The patient shall be isolated in accordance with Section 2518 if determined by clinical observation or by laboratory findings to be infectious. The degree of isolation shall be determined by the local health officer, who should, whenever possible, be advised by a physician specially qualified in this disease. If isolation of the patient is required and cannot be carried out at home or if adequate therapy is not available, the State Department of Public Health shall be notified and shall designate a hospital where the patient shall be isolated and treated. Apparently arrested or inactive cases, and persons who have been in close contact with a case for a prolonged period, shall be kept under observation as long as deemed necessary by the local health officer to determine if they have become infected or the disease reactivated. All reports pertaining to cases of leprosy are confidential and the identity of patients shall not be divulged except as may be necessary for the protection of the public health. s 2584. Leptospirosis (Including Weil's Disease). There are no restrictions on case or contacts. s 2585. Lymphogranuloma Venereum. (See Section 2636 on Venereal Diseases.) s 2586. Malaria. The patient shall be confined during the clinical phases of the disease in a room or dwelling satisfactorily protected against mosquitoes. s 2588. Measles. The patient shall be isolated in accordance with Section 2518 during the period of catarrhal symptoms and for seven days after the appearance of the rash. Restriction on contacts is not required, except at the discretion of the local health officer. s 2590. Meningitis, Meningococcal or Meningococcemia. (a) The patient shall be isolated in accordance with Section 2518 until the end of the febrile period and until all acute symptoms have subsided. (b) Contacts. Quarantine of contacts is not required, except at the discretion of the local health officer, but intimate contacts should be kept under frequent medical observation for a minimum of three days subsequent to diagnosis of the case. Prophylactic treatment of household contacts under medical supervision may be required by the health officer prior to release. s 2592. Mumps. The patient shall be isolated in accordance with Section 2518 until the swelling of the salivary glands has subsided. There are no restrictions on contacts. s 2593. Neoplasm, Cancer. (a) Definitions. (1) Department means Department of Health Services. (2) Director means the Director of the Department of Health Services. (3) Regional cancer registry means the organization authorized to receive and collect cancer data for a designated area of the state and which maintains the system by which the collected information is reported to the Department. (4) Cancer means all malignant neoplasms, including carcinoa in situ, which are specified in Volume I of the 1986 California Cancer Reporting System Standards and as set forth in the International Classification of Diseases for Oncology Field Trial Edition 1986. (5) Case means a cancer diagnosis for an individual who is either a resident of the designated area of the regional cancer registry, regardless of where the individual was treated or diagnosed, or seen at a cancer reporting facility, other facility or by a physician within the designated area of the regional cancer registry, regardless of where the individual resides. (6) Active follow-up program means a system for determining the vital status of each reported case no later than twelve months after the date of the last reported contact. This date is defined in Volume I of the 1986 California Cancer Reporting System Standards. (7) Cancer reporting facility means a hospital or other facility which treats or diagnoses cancer and is also one of the following: (A) A facility currently licensed as a health facility under the provisions of Chapter 2, commencing with Section 1250, of Division 2 of the Health and Safety Code; (B) A surgical clinic licensed under Chapter 1, Section 1204, of Division 2 of the Health and Safety Code; (C) A facility covered by the provisions of Section 1206, except for subsection (f), of the Health and Safety Code which, while not licensed as a clinic, is operated for the predominant purpose of diagnosing or treating cancer or where a minimum of 100 or more cancer cases are diagnosed or treated in a year. (8) Quality Control System means operational procedures by which the accuracy, completeness and timeliness of the information reported to the Department can be determined and verified. These criteria are defined in Volume I of the 1986 California Cancer Reporting System Standards. (9) Certified Tumor Registrar (CTR) means the designation given to individuals who pass the certification examination given by the National Tumor Registrars Association (NTRA). (10) Population-based means that all cases are drawn from a defined population of known size and characteristics, usually one within a defined geographic area. (11) Cancer incidence data means information on new cases of cancer including the required data listed in the 1986 California Cancer Reporting System Standards and counts of these cases by their characteristics such as age, sex and ethnicity, and by anatomic site and morphology. (12) Instance of cancer means case of cancer as defined in subsection (a)(5) above. (13) Modeled after the Cancer Surveillance Program of Orange County means a population-based registry that collects treatment data, has a phased implementation, collects follow-up data, has a community advisory component and receives data in a machine-readable format from cancer reporting facilities as defined in subsection (a)(7) above. (b) Reporting requirements. The Director shall designate cancer as a disease to be mandatorily reported for all counties within the State. All counties shall be assigned to a designated regional cancer registry. When the Director designates cancer as a disease to be mandatorily reported within an area, the Director shall designate the initial mandatory reporting period, which may be less than a full calendar year, for which the regional registry will submit cases to the Department. (1) A regional cancer registry shall establish and maintain a cancer reporting system which is able to report 97 percent of the incident cases in the initial designated reporting period and each calendar year. (2) The regional cancer registry shall have suitable arrangements to obtain data for reporting resident cases diagnosed or treated outside the designated area of the regional cancer registry. (3) The regional cancer registry shall report to the Department all cases diagnosed or treated in a calendar year or initial reporting period within twelve months after the close of that calendar year or initial reporting period. (4) The regional cancer registry shall submit, for each reportable case, the required data specified in Volume I, Section 13, of the 1986 California Cancer Reporting System Standards. (5) The regional cancer registry shall report to the Department all follow-up information provided by cancer reporting facilities with an active follow-up program no later than six months after the cancer reporting facility provides the information to the regional registry. In addition, each regional registry shall implement within three years of the designation of mandatory cancer reporting for the region a program of active follow-up for all resident cases not otherwise being followed by a cancer reporting facility. The results of the active follow-up program of the regional registry shall be reported to the Department quarterly. (6) Data submitted to the Department by the regional cancer registry shall be in machine-readable form. The format and codes used shall be as specified by the Department. (7) The regional cancer registry shall maintain a system of quality control in accordance with procedures approved by the Department. (8) Representatives of the Department shall have access to the source data and the stored data in the regional cancer registry for the purpose of quality control assessments. This includes access to all cancer records maintained by a reporting facility, physician, individual or agency providing diagnostic or treatment services to cancer patients within the region. (9) The regional cancer registry shall maintain confidentiality of data as required in Section 211.5, Health and Safety Code, and shall maintain a security system for records which contain identifying data. This system shall be reviewed and approved by the Department. (10) When cancer is designated a reportable disease in a region, the corresponding regional cancer registry shall inform the public that cancer has been designated as a disease required to be reported in that region and that each patient diagnosed or treated with a Reportable Neoplasm will be reported to the Department as required by law. (11) Cancer reporting facilities within a reporting region shall report to the regional cancer registry the required data as listed in Volumes I and III of the 1986 California Cancer Reporting System Standards. These reports shall conform to Volumes I, II and III of the 1986 California Cancer Reporting System Standards. When a cancer reporting facility fails to produce reports meeting the standards cited above, the regional cancer registry may perform the data collection and collect compensation from the facility for the activity at cost. (12) Cancer reporting facilities shall report to their regional cancer registry each reportable case within six months of the time the case comes under the care of, or is admitted to, the facility. (13) Cancer reporting facilities with an active follow-up program shall report follow-up information to the regional cancer registry no less frequently than quarterly. (14) A facility not already defined as a cancer reporting facility under these regulations which diagnoses or treats cancer and is a primary care clinic as defined in Section 1204, Health and Safety Code or an acute psychiatric hospital as defined in Section 1250, Health and Safety Code shall report each cancer case to its regional cancer registry, or to the local health department, the choice to be determined by the regional registry, using the Confidential Morbidity Report (Form PM-110), shown below, within 30 days of the date the patient is admitted to the facility or treated in the facility for the first time. These reports shall conform to California Cancer Reporting System Standards, Volume IV. (15) Physicians and surgeons caring for cancer patients not referred to a facility defined as a cancer reporting facility under these regulations shall report each cancer case to the regional cancer registry or to the local health department, the choice to be determined by the regional registry, using the Confidential Morbidity Report (PM-110), within 30 days of seeing the patient for the cancer for the first time. These reports shall conform to California Cancer Reporting System Standards, Volume IV. (16) Cancer reporting facilities shall submit their cancer cases and follow-up information to the regional cancer registry in machine-readable form. The format and codes used shall be as specified by the Department in the 1986 California Cancer Reporting System Standards Volume II. (17) Cancer reporting facilities may elect to have the regional cancer registry staff do the cancer data collection. They may do so by a contract with the regional cancer registry to identify and report the cancer cases with the facility reimbursing the regional registry for that registry's expense. (18) Cancer reporting facilities and physicians shall employ a mechanism to ensure that their patients are informed that cancer has been designated a reportable disease and that the facility will report each patient with cancer to the Department as required by law. Patient information sheets for this purpose will be supplied to physicians by the Department. (c) Staffing. The identification and collection of cancer data in the regional cancer registries and cancer reporting facilities shall be performed by Certified Tumor Registrars (CTR) or staff eligible to take the certification examination. (d) Training and Credentialing Period. Reporting facilities so requesting upon application to the regional registry, may be granted a credentialing period of up to 24 months for the purpose of obtaining training to meet the requirements set forth in subsection (c) above. No credentialing period may be granted to extend beyond 30 months from the effective date of mandatory cancer reporting for the region or beyond July 1, 1990. During a credentialing period the reporting facility must meet the quality and other reporting standards. It is the responsibility of the Department, which may be carried out by the regional cancer registries, to assure that adequate tumor registrar training resources are available for no less than 24 months following the initiation of mandatory reporting in a region. (e) Designation of Agent. The Director may designate and contract with any agency to act as the Department's agent for the maintenance of the regional cancer registry. The designated agent shall comply with all regulations for the regional cancer registry. (f) Revocation of Designation. The Director shall have the authority to revoke the designation as Departmental agent. Revocation shall be effective no sooner than 30 days after a written notice to revoke the designation has been served. Note: Authority cited: Sections 208, 210 and 211.3, Health and Safety Code. Reference: Sections 210, 211.3 and 211.5, Health and Safety Code. s 2594. Pertussis (Whooping Cough). The patient shall be isolated in accordance with Section 2518 during the early catarrhal period and for 21 days after the appearance of the typical paroxysmal cough. The isolation provisions shall be adequate to prevent exposure of young children to the patient. Restrictions on contacts not required. s 2595. Physically Handicapped Children (See subchapter 3). s 2596. Plague. Cases and Suspect Cases to Be Reported by Telephone. (See Section 2502(c).) (a) All laboratory specimens submitted for the purpose of establishing a diagnosis shall be examined only in such laboratories as may be designated by the Director of the State Department of Health Services. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human plague, such laboratory shall communicate immediately by telephone with the State Department of Health Services Microbial Diseases Laboratory for instruction. (b) Isolation. The patient shall be confined in a dwelling free from rodents and fleas and shall be isolated in accordance with Section 2516. The period of isolation shall not be terminated until two days after all symptoms have subsided. In cases of pneumonic plague, strict precautions against respiratory transmission of the disease shall be enforced. (c) Contacts. Contacts of cases of plague shall be kept under quarantine until the health officer is satisfied that they have not contracted the infection, except that contacts of cases of pneumonic plague shall be kept in quarantine for a period of at least seven days after last exposure. Note: Authority cited: Sections 100180, 100275, 120130 and 120145, Health and Safety Code. Reference: Sections 100180, 100275, 120145, 120190, 120215 and 120240, Health and Safety Code. s 2597. Q Fever. No restrictions on cases or contacts. s 2598. Pneumonia, Infectious (Except Pneumonic Plague). s 2600. Poliomyelitis, Acute Anterior. The case shall be isolated in accordance with Section 2518 for a period of seven days from the onset of illness or for the duration of fever if longer. Restrictions on contacts is not required, except at the discretion of the local health officer. s 2602. Psittacosis. The patient shall be isolated in accordance with Section 2518 during the acute stages. There are no restrictions on contacts. s 2603. Control of Pet Birds. (a) The department or local health officers may quarantine any species of pet birds imported into this State from states and countries where psittacosis or other diseases transmitted by pet birds to human beings have been reported by an official agency to be currently prevalent in pet birds. Such quarantine shall remain in effect until removed by the department, or local health officers, following proof that the quarantined birds are not infected with psittacosis or other diseases transmissible by pet birds to human beings. (b) Whenever a pet bird or birds are suspected to be a source of human disease or a pet bird or birds are infected with a disease which is a potential source of human disease and, in the opinion of the department or local health officers, it is deemed necessary for the protection of the public, the pet bird or birds shall be quarantined. Such quarantine shall remain in effect until the quarantine authority has evidence that the quarantined bird or birds are not a hazard to the public's health. Such evidence may be obtained by the following actions: (1) A sufficient number of birds, such numbers to be specified by the quarantine authority, are to be provided for laboratory testing in a laboratory approved by the department. (2) If, upon completion of the necessary laboratory test no evidence is found that the birds are infected with a disease hazardous to human health, they may be released from quarantine. Such release shall be made only by the quarantine authority. (3) If upon completion of the necessary laboratory test there is evidence that the bird or birds are infected with a disease hazardous to human health, the bird or birds shall remain under quarantine until the hazard has been eliminated to the satisfaction of the quarantine authority. (4) If, following treatment methods or other methods which may be used to eliminate the hazard in the quarantined bird or birds, the quarantine authority finds that the hazard to humans no longer exists, it may release the bird or birds from quarantine. (5) The owner of the quarantined bird or birds shall have the option to destroy the quarantined bird or birds if he so desires. In such case the quarantine will be lifted following evidence that the infected premises are thoroughly disinfected. Note: Authority cited: Sections 100275 and 121745, Health and Safety Code. Reference: Section 121745, Health and Safety Code. s 2603.5. Control of Psittacine Birds. Note: Authority cited: Sections 208 and 2100, Health and Safety Code. s 2604. Rabies, Human. The patient shall be isolated in accordance with Section 2518 during the course of the disease. There are no restrictions on contacts of a human case. Note: Authority cited: Sections 102, 208 and 1900-2000, Health and Safety Code. s 2606. Rabies, Animal. (a) Reporting. Any person having knowledge of the whereabouts of an animal known to have or suspected of having rabies shall report the facts immediately to the local health officer. The health officer shall likewise be notified of any person or animal bitten by a rabid or suspected rabid animal. In those areas declared by the Director of the State Department of Health Services to be rabies areas (See Section 1901.2, California Health and Safety Code) the local health officer shall be notified when any person is bitten by an animal of a species subject to rabies, whether or not the animal is suspected of having rabies. (b) Isolation. Any rabid animal, clinically suspected rabid animal, or biting animal shall be isolated in strict confinement as follows: (1) Isolation of Rabid Animals or Clinically Suspected Rabid Animals. Any rabid animal or clinically suspected rabid animal shall be isolated in strict confinement under proper care and under the observation of a licensed veterinarian, in a pound, veterinary hospital, or other adequate facility in a manner approved by the local health officer, except where such responsibility has been delegated to a comparable officer by the governing body, and shall not be killed or released for at least 10 days after the onset of symptoms suggestive of rabies, with the exception that such animals may be sacrificed with permission of the local health officer for the purpose of laboratory examination for rabies using the fluorescent rabies antibody (FRA) test in an approved public health laboratory. (2) Isolation of Biting Animals. At the discretion of the local health officer, any animal which bites or otherwise exposes a person shall be isolated in strict confinement in a place and manner approved by the local health officer and observed for at least 14 days (dogs and cats 10 days) after the day of infliction of the bite, with the exception that the following alternative to the 10 day isolation of dogs and cats is permitted -dogs or cats which have been isolated in strict confinement under proper care and under observation of a licensed veterinarian, in a pound, veterinary hospital, or other adequate facility in a manner approved by the local health officer, may be released from isolation by the local health officer after five days of veterinary observation if upon conducting a thorough physical examination on the fifth day or more after infliction of the bite, the observing veterinarian certifies that there are no clinical signs or symptoms of any disease. Notwithstanding the foregoing provisions, a local health officer may authorize, with permission of the owner and other legal restrictions permitting, the euthanasia of a biting animal for the purpose of laboratory examination for rabies using the fluorescent rabies antibody (FRA) test in an approved public health laboratory. (3) Isolation of Biting Animals in Officially Declared Rabies Areas. In officially declared rabies areas (see Section 1901.2, California Health and Safety Code) the isolation described in paragraph (2) above shall be mandatory for any animal of a species subject to rabies that has bitten or otherwise exposed a person, with the exception of rodents (members of the order Rodentia) and rabbits and hares (members of the order Lagomorpha). (4) Laboratory Examination of Rabid Animals, Clinically Suspected Rabid Animals or Biting Animals Which Die or Have Been Killed. If any rabid animal, clinically suspected rabid animal or biting animal dies or has been killed, adequate specimens shall be obtained and examined in a public health laboratory approved by the department. No person shall destroy or allow to be destroyed the brain of an animal of a species subject to rabies that has bitten or otherwise exposed a person before the destruction of such brain has been authorized by the local health department; provided, however, that the provisions of this paragraph (4) shall not apply to rodents (members of the order Rodentia ) and rabbits or hares (members of the order Lagomorpha ). (c) Animal Contacts. Any animal of a species subject to rabies which has been bitten by a known rabid or suspected rabid animal or has been in intimate contact with a rabid or suspected rabid animal shall be quarantined in a place and manner approved by the local health officer, except where such responsibility has been delegated to a comparable officer by the local governing body, for a period of six months or destroyed, with the exception that the following alternatives are permitted in the case of dogs and cats as follows: (1) If a dog over one year of age has been vaccinated against rabies within 36 months but not less than 30 days with a rabies vaccine of a type approved by the Department for a maximum immunity duration of at least 36 months, the dog may be revaccinated immediately (within 48 hours) in a manner prescribed by the Department and quarantined in a place and manner approved by the local health officer for a period of 30 days following revaccination. (2) If a dog under one year of age has been vaccinated against rabies within 12 months but not less than 30 days with a rabies vaccine of a type approved by the Department, the dog may be revaccinated immediately (within 48 hours) in a manner prescribed by the Department and quarantined in a place and a manner approved by the local health officer for a period of 30 days. (3) If a cat has been vaccinated within one year but not less than 30 days with an annual type feline rabies vaccine or if a cat has been vaccinated under one year of age with a 36-month type of feline rabies vaccine within 12 months but not less than 30 days, the cat may be revaccinated immediately (within 48 hours) in a manner prescribed by the Department and quarantined in a place and manner approved by the local health officer for a period of 30 days following revaccination. (4) If a cat over one year of age has been vaccinated against rabies and has been vaccinated within 36 months and more than 30 days with a 36-month type feline rabies vaccine, the cat may be revaccinated immediately (within 48 hours) in a manner prescribed by the Department and quarantined in a place and manner approved by a local health officer for a 30-day period following revaccination. Note: Authority cited: Sections 208, 1905 and 3123, Health and Safety Code. Reference: Sections 1901, 1903, 1905, 1907 and 3123, Health and Safety Code. s 2606.2. Rabies Quarantine. If rabies is known to exist within an area, the local health officer may establish a rabies quarantine and shall define the boundaries of the quarantine area and specify the animals subject to quarantine, and all such animals within the quarantined area shall be kept in strict confinement upon the private premises of the owner, keeper or harborer at all times until the quarantine is terminated by the local health officer. Note: Authority cited: Sections 102, 208 and 1900-2000, Health and Safety Code. s 2606.4. Officially Declared Rabies Areas. (a) Administration and Enforcement. For purposes of administration and enforcement of Section 1920, California Health and Safety Code, in officially declared rabies areas, the following shall apply: (1) Licensing and Vaccination Procedure. The vaccination of dogs four months of age or older as required by subdivision (b), Section 1920, California Health and Safety Code, shall be held a requisite to licensing as required under subdivision (a) therein. Completion of the licensing procedure consists of issuance of a license tag or a vaccination tag bearing the license data and shall be carried out only after presentation of a current valid official vaccination certificate. Current copies of the Compendium of Canine Rabies Vaccines approved by the Department, together with the maximum immunity duration periods prescribed by the Department for each type product, are available upon request from the Veterinary Public Health Unit, Infectious Disease Section, California Department of Health Services, 2151 Berkeley Way, Berkeley, California, 94704, telephone (415) 540-2391. (2) Vaccination Certificates. Official vaccination certificates must show: (A) the name, address and telephone number of the dog's owner; (B) the description of the dog, including breed, color, age, and sex; (C) the date of immunization; (D) the type of rabies vaccine administered; (E) the name of the manufacturer; and (F) the lot number of the vaccine used. Such certificates shall bear the signature of the veterinarian administering the vaccine or a signature authorized by him, and in addition such certificate shall be stamped, printed, or typed with his name, address and telephone number for legibility, with the exception that at dog vaccination clinics conducted pursuant to Section 1920(f) of the Health and Safety Code, vaccination certificates approved by the local health officer may be used provided that the specific clinic is identified upon the vaccination certificate and records are maintained containing the information specified under items (E) and (F) above. (3) Interval Permitted for Procurement of License. The vaccination of dogs four months of age against rabies as required under subdivision (b), Section 1920, California Health and Safety Code, and the license required by subdivision (a) of said section shall be procured not later than 30 days after the dog attains the age of four months. The license renewal shall be procured not later than 60 days after expiration of the previously issued license. (4) Rabies Control Activities Reporting. During such time as a county is under official declaration as a rabies area, each local official responsible for the various phases of local dog or rabies control within each city, county and city or cities, or county shall make quarterly rabies control activities reports to and on forms furnished by the Department. Such reports shall be submitted to the Department by the local officials responsible for the various phases of local dog or rabies control through the local health officer so as to reach the Department not later than 30 days following each quarter. (b) Vaccination of Dogs Against Rabies. Dogs shall be considered to be properly vaccinated for the purposes of Section 1920, California Health and Safety Code, when injected at four months of age or older with an approved canine rabies vaccine and revaccinated in accordance with the following conditions: (1) Primary Immunization. Primary immunization shall be defined as the initial inoculation of an approved canine rabies vaccine administered to young dogs between the ages of 4 to 12 months. (2) Minimum Age for Rabies Vaccination. The minimum age for which rabies immunization of dogs shall be accepted for purposes of dog-owner compliance with requirements for rabies vaccination and for purposes of issuance of dog licenses (See Section 2606.4(a)(1)) is 4 months. (3) Revaccination Intervals. Dogs shall be revaccinated one year (12 months) after the primary immunization with an approved type of rabies vaccine. Dogs receiving vaccination after primary immunization or any dog receiving its initial rabies vaccination over 12 months of age shall be revaccinated thereafter at least once every three years (36 months) with an approved type rabies vaccine. (c) Issuance of Dog Licenses. In no instances shall a dog license be issued for a period beyond the date upon which revaccination is due except, following primary immunization in a local jurisdiction which is on a fixed one-year licensing period, a license may be issued for a period beyond the revaccination date if early revaccination cannot be required in accordance with subdivision (d). (d) Notwithstanding the rabies revaccination intervals specified in Section 2606.4(b)(3) above, local authorities may require revaccination prior to issuance of a license provided that revaccination against rabies in no instance shall be required sooner than one year (12 months) follow ing a primary immunization or sooner than 2 years (24 months) following a vaccination of dogs vaccinated over one year (12 months) of age. Note: Authority cited: Sections 208 and 1905, Health and Safety Code. Reference: Sections 1905 and 1920, Health and Safety Code. s 2606.6. Importation of Dogs. All dogs four months of age or older imported into this State for any purpose shall be accompanied by a certificate issued by a licensed veterinarian, stating that the dog or dogs have been vaccinated against rabies within 30 months of the date of importation for dogs vaccinated over 12 months of age or within 12 months for dogs vaccinated under 12 months of age with a canine rabies vaccine of a type approved by the Department for an immunity duration of at least 36 months. Note: Authority cited: Sections 208 and 1905, Health and Safety Code. Reference: Sections 1905 and 1920(b), Health and Safety Code. s 2606.8. Skunk Rabies. (a) Due to the presence of rabies in skunks in California and in many other states and the resultant hazard to the public health of rabies developing in skunks kept as pets, no person shall: (1) trap or capture skunks for pets, (2) trap, capture or hold skunks in captivity for sale, barter, exchange or gift, (3) transport skunks from or into the state except as provided under (b) below. (b) The importation of skunks into California or the exportation of skunks from the State is prohibited except by permit from the California State Department of Health Services to a recognized zoological garden or a research institution. Note: Authority cited: Sections 208 and 1905, Health and Safety Code. Reference: Section 1905, Health and Safety Code. s 2608. Relapsing Fever. (a) (Tick-borne). There are no restrictions on case or contacts. (b) (Louse-borne) Cases and Suspect Cases to Be Reported by Telephone or Telegraph. (See Section 2501(c).) The patient shall be confined during the clinical phase of the disease in a dwelling or room free of rodents or lice. There are no restrictions on contacts. All lice and louse eggs on the patient's body, hair, or clothing shall be destroyed. Household contacts shall be louse-free. s 2610. Rheumatic Fever, Acute. There are no restrictions on case or contacts. s 2611. Rocky Mountain Spotted Fever. There are no restrictions on case or contacts. s 2612. Salmonella Infections (Other Than Typhoid Fever). (a) Any illness in which organisms of the genus Salmonella (except the typhoid bacillus) have been isolated from feces, blood, urine or pathological material shall be reported as a Salmonella infection. A culture of the organisms on which the diagnosis is established shall be submitted first to a local public health laboratory and then to the State Microbial Diseases Laboratory for definitive identification. The period of isolation in accordance with Section 2518 shall be until clinical recovery. The patient shall be subject to supervision by the local health officer who may require, at his discretion, release specimens of feces for testing in a laboratory approved by the State Department of Health Services. However, no patient shall be released from supervision to engage in any occupation involving the preparation, serving or handling of food, including milk, to be consumed by individuals other than his immediate family, nor to engage in any occupation involving the direct care of children or of the elderly or of patients in hospitals or other institutional settings until two successive authentic specimens of feces taken at intervals of not less than 24 hours, beginning at least 48 hours after cessation of specific therapy, if any was administered, have been determined, by a public health laboratory approved by the State Department of Health Services to be negative for Salmonella organisms. (See Section 2534.) (b) Carriers. Any person who harbors Salmonella organisms three months after onset is defined as a convalescent carrier and may be restricted at the discretion of the local health officer. Any person continuing to harbor Salmonella organisms one year after onset is a chronic carrier. Any person who gives no history of having had Salmonellosis or who had the illness more than one year previously who is found to harbor Salmonella organisms on two successive specimens taken not less than 48 hours apart is also considered to be a chronic carrier. Chronic carriers of Salmonella, other than S. typhosa, shall be restricted at the discretion of the local health officer. (c) Contacts. Restrictions on contacts shall be at the discretion of the local health officer. Note: Authority cited: Sections 208 and 3123, Health and Safety Code. Reference: Section 3123, Health and Safety Code. s 2612.1. Turtle Salmonellosis. (a) Except as otherwise provided in this section, it shall be unlawful to import, sell or offer for sale or distribution to the public any live turtle(s) with a carapace length of less than 4 inches. (b) The Department or any authorized representative thereof, or any local health officer or his representative may order the humane destruction of any turtle(s) that are unlawful to import, sell or offer for sale or distribution to the public under subsection (a) above. (c) The Department or any authorized representative thereof, or any local health officer or his representative may quarantine turtles, take samples of tank water or any other appropriate samples of or from turtles offered for sale or distribution for the purpose of testing for Salmonella and Arizona organisms. The Department or any local health officer may order the immediate humane destruction of any lot of turtles found contaminated with Salmonella, Arizona, or other organisms which may cause or have caused disease in humans. (d) Shipments of turtles under 4 inches in carapace length are permitted to a governmental agency, or to a recognized research or educational institution for research or teaching purposes or to a zoological garden for display. (e) The following warning shall be posted conspicuously for buyer information at every display of turtles for retail sale or distribution or where the public may come in contact with turtles: CAUTION: Turtles may transmit bacteria causing disease in humans. It is important to wash the hands thoroughly after handling turtles or material that had contact with turtles. Do not allow water or any other substance that had contact with turtles to come in contact with food or areas where food is prepared. Make sure that these precautions are followed by children and others handling turtles. (f) For each sale of turtle(s) at retail, a sales slip shall be issued by the seller to the purchaser at time of the sale. The sales slip shall include the name, address and telephone number of the purchaser and the seller, and the date of sale. The sales slip shall have printed legibly on its front the warning statement contained in subsection (e) above. The seller shall keep a copy of the sales slip, which shall include the name, address and telephone number of the purchaser for not less than one year, and keep a complete record of all purchases, losses and other dispositions of turtles. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 205, 3051-3053, Health and Safety Code. s 2613. Shigella Infections (Dysentery, Bacillary). (a) The period of isolation in accordance with Section 2518 shall be until the acute symptoms have subsided. The patient shall be subject to supervision by the local health officer who may require, at his discretion, release specimens of feces for testing in a laboratory approved by the State Department of Health Services. However, no patient shall be released from supervision to engage in any occupation involving the preparation, serving or handling of food, including milk, to be consumed by individuals other than his immediate family, nor to engage in any occupation involving the direct care of children or of the elderly or of patients in hospitals or other institutional settings until two successive authentic specimens of feces or of rectal swabs, taken at intervals of not less than 24 hours, beginning at least 48 hours after cessation of specific therapy, if any was administered, have been determined, by a public health laboratory approved by the State Department of Health Services, to be negative for Shigella organisms. (See Section 2534.) (b) Contacts. Restrictions on contacts shall be at the discretion of the local health officer. Note: Authority cited: Sections 208 and 3123, Health and Safety Code. Reference: Section 3123, Health and Safety Code. s 2614. Smallpox (Variola). Cases and Suspect Cases to Be Reported by Telephone. (See Section 2502(c).) (a) Patient. The patient shall be isolated in accordance with Section 2516 until the scabs have separated and the scars have completely healed. (b) Household Contacts. Household contacts shall be quarantined for at least 17 days after last exposure, except that the local health officer may, at his discretion, when the patient is properly isolated, release from quarantine persons who shall submit to vaccination against smallpox and prove to the satisfaction of the local health officer that the vaccination is successful. Such persons shall remain in quarantine until released by the local health officer. (c) Casual Contacts. A person who has been exposed to the risk of contracting the disease by proximity to a case or to a suspected case of smallpox, shall be quarantined for a period not less than 17 days from the last date of exposure. Such persons may be released from quarantine if evidence of protection against smallpox is established to the satisfaction of the local health officer. (d) Vaccination. The local health officer shall provide at public expense, as available, smallpox vaccination for persons who have been exposed to a case or suspected case of smallpox. (e) Laboratory. Whenever a laboratory receives a specimen for the laboratory diagnosis of smallpox (variola), such laboratory shall communicate immediately by telephone with the State Department of Health Services Viral Rickettsial Disease Laboratory for instruction. Note: Authority cited: Sections 100180, 100275, 120130 and 120145, Health and Safety Code. Reference: Sections 100180, 100275, 120130, 120190, 120195 and 120215, Health and Safety Code. s 2616. Streptococcal Infections, Hemolytic (Including Scarlet Fever and Streptococcal Sore Throat). (a) The patient shall be isolated in accordance with Section 2518 for not less than seven days from onset. Patients treated with an effective antibiotic may be released upon clinical recovery. (b) Contacts. Household contacts should be kept under frequent medical observation for the development of streptococcal disease. Restriction on contacts is not required, except at the discretion of the local health officer. s 2617. Syphilis. (See Section 2636 on Venereal Diseases.) s 2618. Tetanus. There are no restrictions on case or contacts. s 2620. Trachoma. The patient shall be isolated in accordance with Section 2518 during the acute stages and when not under medical treatment satisfactory to the health officer. There are no restrictions on contacts. s 2622. Trichinosis. The local health officer shall make an investigation to determine the source of infection. If the suspected source is a commercial food product, the health officer shall report the fact at once to the State Department of Public Health. There are no restrictions on case or contacts. s 2624. Tuberculosis. A person having or suspected of having tuberculosis in a communicable stage shall be considered as fulfilling the requirements of modified isolation as long as he is under adequate medical supervision and observes the instructions issued by the local health officer. The isolation shall be adequate for the protection of persons residing within the household as well as the public. A person having tuberculosis in a communicable stage, who refuses to observe the instructions of the local health officer and thereby needlessly exposes others to infection, shall be placed in strict isolation at home until such time as the local health officer feels that such isolation is no longer necessary for the protection of the public; and, in the event that such household isolation proves inadequate for the protection of members of the household or community, the patient shall be placed in isolation in quarters designated by the local health officer, until such time as such isolation is no longer necessary for the protection of the public. The person officially in charge of a sanatorium or other place where tuberculosis patients are cared for shall be responsible for immediately notifying the health officer in whose territory a patient resides whenever such patient having tuberculosis in a communicable stage leaves the institution. In every case in which a non-communicable tuberculous patient has been placed in a nursing home the local health officer or his deputy shall be responsible for the continued surveillance of such a patient to ensure that he remains non-communicable. s 2626. Tularemia. Cases and Suspect Cases to Be Reported by Telephone. (See Section 2502(c).) There are no restrictions on case or contacts. Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human tularemia, such laboratory shall communicate immediately by telephone with the State Department of Health Services Microbial Diseases Laboratory for instruction. Note: Authority cited: Sections 100180, 100275 and 120130, Health and Safety Code. Reference: Sections 100180, 100275, 120130 and 120190, Health and Safety Code. s 2628. Typhoid Fever. (a) Case. A culture of the organism on which the diagnosis of typhoid fever is established shall be submitted first to a local public health laboratory and then to the State Microbial Diseases Laboratory for phage typing. The patient shall be isolated in accordance with Section 2518 until clinical recovery. The patient shall remain subject to supervision by the local health officer until three successive specimens of feces and urine taken at least 24 hours apart, beginning at least one week after discontinuation of specific therapy and not earlier than one month after onset of disease, have been found negative for typhoid bacilli at a public health laboratory approved by the State Department of Health Services. If any one of this series is positive, cultures of both urine and feces shall be repeated at intervals of 1 month during the 12-month period following onset, until at least three sets of negative cultures are obtained. The patient shall not take any part in the preparation, serving, or handling of milk or other food to be consumed by individuals other than his immediate family, or participate in the management of a dairy, milk distributing plant, boarding house, restaurant, food store, or any place where food is prepared or stored, or engage in any occupation involving the direct care of young children or the elderly or of patients in hospitals or other institutional settings until release specimens have been obtained, as described above, and are negative for typhoid organisms. (See Section 2534.) (b) Contacts. There are no restrictions on contacts, except that any member of the patient's household shall not take part in the preparation, serving, or handling of milk or other food to be consumed by individuals, other than the immediate family except at the discretion and under the restrictions of the local health officer. (c) Definition of Carriers. (1) Convalescent Carriers: Any person who harbors typhoid bacilli for three or more months after onset is defined as a convalescent carrier. Convalescent carriers may be released when three consecutive negative specimens of feces and urine taken at intervals of not less than one month, beginning at least one week after discontinuation of specific therapy are obtained. Such release may be granted at any time from 3- 12 months after onset. (2) Chronic Carriers: If the person continues to excrete typhoid bacilli for more than 12 months after onset of typhoid fever, he is defined as a chronic carrier. Any person who gives no history of having had typhoid fever or who had the disease more than one year previously, and whose feces or urine are found to contain typhoid bacilli on two separate examinations at least 48 hours apart, confirmed by State Microbial Diseases Laboratory, is also defined as a chronic carrier. All carriers shall be reported to the local health officer. Such reports shall be kept confidential and shall not be divulged to persons other than the carrier and his immediate family, except as may be required for the protection of the public health. (3) Other Carriers: A person should be held under surveillance if typhoid bacilli are isolated from surgically removed tissues, organs, e.g., gallbladder, kidney, etc., or from draining lesions such as osteomyelitis. If the person continues to excrete typhoid bacilli for more than 12 months he is defined as a chronic carrier and may be released after satisfying the criteria for other chronic carriers. (d) Carrier Restrictions and Supervision. When any known or suspected carrier of this disease is reported to the local health officer, he shall make an investigation and submit a report to the State Department of Health Services. He shall have performed laboratory work as defined in subsection (e) below. Any known or suspected carrier of this disease shall be subject to modified isolation and the provisions of this isolation shall be considered as fulfilled during such period as he complies with the instructions issued by the State Department of Health Services and the local health officer. (1) Restrictions. Instructions shall be given to the carrier in writing by the local health officer. (2) Supervision. The local health officer or his representative shall communicate with each carrier living within his jurisdiction at least twice a year to learn of any changes in the carrier's address, occupation or activities and to determine whether all instructions are being carried out. The local health officer shall submit a report to the State Department of Health Services every six months on each carrier in his jurisdiction. Any changes of address shall be reported immediately. (e) Laboratory Tests. Whenever laboratory tests are required for the release of typhoid cases or carriers, the tests shall be taken by the local health officer or his representatives under such conditions that he can certify as to their being authentic specimens of the individual, and shall be submitted to a public health laboratory approved by the State Department of Health Services. Cultures from release specimens which are found positive by the approved laboratory shall be forwarded to the State Division of Laboratories for phage typing. (f) Requirements for Release of Chronic Carriers. Authority for Release of Carriers. Any person ascertained to be a chronic typhoid carrier may be released from supervision by the Director of the State Department of Health Services or his designated representative provided the carrier applies for such release through his local health officer and fulfills the requirements specified by the Director of the State Health Department or his designated representative. (1) Fecal Carriers. A person who has been determined to be a chronic fecal carrier may be released if six successive authentic stool and urine specimens taken at intervals of not less than one month are determined to be negative by a public health laboratory approved by the State Department of Health Services. If any one of these specimens is positive, he shall not be released unless the carrier condition has been cured by cholecystectomy, or by such other methods as are acceptable to the State Department of Health Services. The necessary requirements for such release will be submitted to the carrier and to the local health officer by the State Department of Health Services when application for the release is submitted. (2) Cholecystectomy. The local health officer or, in areas not served by a local health department, the Director of the State Department of Health Services, shall be notified before a cholecystectomy is undertaken unless a specimen of duodenal contents, containing bile, has been found positive for typhoid bacilli, since in some cases the infection is not localized in the gall bladder. The patient shall be released under the same conditions as outlined for a fecal carrier. (3) Urinary Carriers. A person who has been determined to be a chronic urinary carrier may be released if six successive authentic urine specimens taken at intervals of not less than one month are determined to be negative by a public health laboratory approved by the State Department of Health Services. If any one of these specimens is positive, he may be released following the surgical removal of the infected kidney or by such other methods as are acceptable to the State Department of Health Services. The necessary requirements for such release will be submitted to the carrier and to the local health officer by the State Department of Health Services when application for the release is submitted. Note: Authority cited: Sections 208 and 3123, Health and Safety Code. Reference: Section 3123, Health and Safety Code. s 2630. Typhus Fever (Flea-Borne, Endemic Type). The patient shall be confined during the clinical phase of the disease in a dwelling or room free of rodents, fleas or lice. There are no restrictions on contacts. s 2632. Typhus Fever (Louse-Borne, Epidemic Type). Cases and Suspect Cases to Be Reported by Telephone or Telegraph. (See Section 2501(c).) The patient shall be confined during the clinical phase of the disease in a dwelling or room free of rodents or lice. All lice and louse eggs on the patient's body, hair, or clothing shall be destroyed. Household contacts shall be louse-free. There are no other restrictions on contacts. s 2636. Venereal Diseases. (a) Sections 2636 to 2636(m) inclusive pertain to the venereal diseases and, unless otherwise specified, shall include syphilis, gonococcus infection, granuloma inguinale, lymphogranuloma venereum, and chancroid. (See Chapter 765, Statutes 1947; also Section 21100, Health and Safety Code.) (b) Reports Confidential. Reports of examinations, cases, investigations and all records thereof made under the regulations for the control of venereal diseases shall be confidential and not open to public inspection and no part thereof divulged, except as may be necessary for the preservation of the public health. (c) Report of Unusual Prevalence. When the local health officer, through investigation, becomes aware of unusual prevalence of venereal diseases, or of unusual local conditions favoring the spread of these diseases, he shall report the fact at once to the State Department of Health Services. (d) Parents or Guardians Responsible for Compliance of Minors. The parents or guardians of minors suffering from a venereal disease shall be legally responsible for the compliance of such minors with the requirements of the regulations relating to the venereal diseases. (e) Certification. Each local health officer shall take every proper means of repressing prostitution, inasmuch as it is the most prolific source of the venereal diseases. Health officers and physicians shall not issue certificates of freedom from venereal diseases to known prostitutes, as such certificates may be used for purposes of solicitation. (f) Diagnosis. The local health officer may require the submission of such specimens as may be designated from cases of venereal disease for examination in a laboratory approved by the State Department of Health Services. The local health officer may require any physician in attendance on a person infected with a venereal disease or suspected of being infected with a venereal disease to submit such specimens as approved by the State Department of Health Services provided, however, nothing shall prevent the physician or individual from having additional examination made elsewhere. (g) Instruction to the Patient. It shall be the duty of the physician in attendance on a person having a venereal disease, or suspected of having a venereal disease, to instruct such patient in precautionary measures for preventing the spread of the disease, the seriousness of the disease, and the necessity for treatment and prolonged medical supervision, and the physician shall, in addition, furnish approved literature on these subjects. Approved literature for distribution to patients may be secured from the State Department of Public Health and the local health departments free of charge. (h) Investigation. All city, county and other local health officers are hereby directed to use every available means to ascertain the existence of, and immediately to investigate, all reported or suspected cases of venereal disease in the infectious stages within their several territorial jurisdictions, and to ascertain the sources of such infections. The attending physician, in every case of venereal disease coming to him for treatment, shall endeavor to discover the source of infection, as well as any sexual or other intimate contacts which the patient was in the communicable stage of the disease. The physician shall make an effort, through the cooperation of the patient, to bring these cases in for examination and, if necessary , treatment. If, within 10 days of identification, any such source of infection or any such contact has not given satisfactory evidence of being under the care of a physician, such person shall be reported to the health officer, the physician's name being kept confidential in any investigation by the health department. In cases in which prostitutes are named as sources of infection, all obtainable information as to name, description, residence, etc., shall be given to the health officer at once. In carrying out such investigations, all health officers are hereby invested with full powers of inspection, examination and isolation of all persons known to be infected with a venereal disease in an infectious stage, or suspected of being infected with a venereal disease in an infectious stage and are hereby directed: (1) To make such examinations as are deemed necessary of persons reasonably suspected of having a venereal disease in an infectious stage. (2) When the individual to be examined is a woman, to provide the services of a woman physician if such physician is available, when so requested by the individual to be examined. (3) To isolate such person, whenever deemed necessary for the protection of the public health. In establishing isolation the health officer shall proceed as provided in Sections 2636(i), 2636(j), 2636(l) and 2636(m). (4) Pursuant to Section 3194.5 of the Health and Safety Code, a person employed by a Public Health Department shall meet the following training requirements as a prerequisite to the performance of venipuncture or skin puncture: (A) Possess a statement signed by a licensed physician and surgeon stating that the individual named in such statement has received adequate training in the proper procedure to be employed in the performance of venipuncture and skin puncture. (B) In order to receive such statement, the venereal disease case investigator shall be trained by a licensed physician and surgeon. The trainee shall observe and receive sufficient instruction and demonstration of the proper technique and procedure to be employed in the performance of venipunctures and skin punctures; in turn, the physician and surgeon shall then observe the procedure and technique of the trainee. (C) When such training has been completed by the trainee to the satisfaction of the physician and surgeon, such physician and surgeon shall execute a statement that the venereal disease case investigator has received adequate training in the proper procedure to be employed in the performance of venipuncture and skin puncture. Satisfaction of these training requirements shall be in addition to other requirements of Section 3194.5 of the Health and Safety Code. (i) Isolation. Any person who presents himself (or herself) to any physician or person for treatment or diagnosis of any venereal disease except late syphilis shall be considered to be in modified isolation. The requirements of this isolation shall be considered fulfilled if the patient remains under adequate and proper treatment until the completion of the course of treatment, except in instances in which, because of occupation, suspicion of prostitution, or other reason, the health officer deems more strict isolation necessary to safeguard other persons. (j) Violation of Isolation to be Reported. Whenever any person while in the infectious or potentially infectious stage of a venereal disease, lapses from treatment for a period of more than 10 days after the time appointed for such treatment, the said diseased person shall be deemed to have violated the requirements of isolation, and the physician or person in attendance upon such case shall report the same at once to the local health department, giving the person's name, address, and report number, together with such other information as requested on the card provided for this purpose, except that this shall not be required in instances in which a report has been received that the patient is under treatment elsewhere. (k) If any person has knowledge that a person infected with a venereal disease is failing to observe adequate precautions to prevent spreading infection, he shall report the facts at once to the local health officer. (l) Gonorrhea. A case of gonococcus infection of the genitourinary tract shall be regarded as subject to isolation until the local health officer is reasonable satisfied that the disease is no longer communicable. (m) Syphilis. A case of syphilis shall be regarded as subject to isolation until, under treatment, all syphilitic lesions of the skin or mucous membrane are completely healed and a competent clinical examination fails to show the presence of any area from which infection may be spread. Any patient who refuses or otherwise fails to receive a full course of a currently accepted method of treatment, or who discontinues treatment prematurely, may be subjected to strict isolation if the health officer deems it necessary. Note: Authority cited: Sections 102.208 and 3194.5, Health and Safety Code. Reference: Section 3194.5, Health and Safety Code. s 2638. Viral Hemorrhagic Fevers (e.g., Crimean-Congo, Ebola, Lassa and Marburg Viruses). Cases and Suspect Cases to Be Reported by Telephone. (See Section 2502(c).) (a) Patient. The patient shall be isolated in accordance with Section 2516. Strict barrier isolation and patient blood, secretion and excreta precautions shall be enforced. The patient shall be instructed to refrain from unprotected sexual activity until secretions are free of virus or for 3 months after illness onset. (b) Laboratory. Whenever a laboratory receives a specimen for laboratory diagnosis of suspected viral hemorrhagic fevers, such laboratory shall communicate immediately by telephone with the State Department of Health Services Viral and Rickettsial Disease Laboratory for instructions. Note: Authority cited: Sections 100180, 100275, 120130, 120145 and 120175, Health and Safety Code. Reference: Sections 100180, 100275, 120130, 120185, 120190, 120195, 120215 and 120240, Health and Safety Code. s 2640. Yellow Fever Cases and Suspect Cases to Be Reported by Telephone or Telegraph. (See Section 2501(c).) The case shall be confined during the clinical phase of the disease in a room satisfactorily protected against mosquitoes. Contacts shall be kept under observation for a period of seven days after the date of last exposure. s 2641.5. Alternative Testing Site. "Alternative Testing Site" means an anonymous HIV testing site funded by the California Department of Health Services, administered by a county health department and operated pursuant to Health and Safety Code, Sections 120890-120895. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.10. Anonymous Counseling and Testing Program. "Anonymous Counseling and Testing Program" means a program offering HIV counseling and testing while maintaining anonymity of the patient. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.15. Anonymous HIV Test. "Anonymous HIV Test" means an HIV test that maintains the anonymity of the patient. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.20. Biological Specimen. "Biological specimen" means any material that is derived from the human body. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Section 1206, Business and Professions Code; and Sections 100180, 101160, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.25. Confidential HIV Test. "Confidential HIV Test" means an HIV test that links the test results to the patient in a restricted manner to protect against unauthorized disclosure of the identity of the patient. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775 and 121025, Health and Safety Code. s 2641.30. Confirmed HIV Test. "Confirmed HIV test" means: (a) a procedure which verifies the presence of HIV infection as determined by any clinical laboratory test or examination used to detect the presence of HIV, a component of HIV, or antibodies to or antigens of HIV, including the HIV antibody (HIV-Ab), HIV p-24 antigen, Western blot (Wb), and immunofluorescence antibody tests; or (b) for the purpose of this Article, all tests used to monitor HIV infection, including HIV nucleic acid detection. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1265 and 1281, Business and Professions Code; and Sections 100180, 101150, 101160, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.35. Department. "Department" means the California Department of Health Services, Office of AIDS. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.45. Health Care Provider. "Health care provider" means an individual who submits a biological specimen to a laboratory for a test to detect the presence of HIV, a component of HIV or antibodies to or antigens of HIV, receives the test results and is; (a) licensed under the provisions of Business and Professions Code, Division 2 (Healing Arts) and acting within his or her scope of practice, or; (b) a designee of a physician and surgeon acting under the general supervision of that physician or surgeon, or; (c) a person working in a publicly-funded confidential counseling and testing program acting under the general supervision of, and following the protocols approved by, the local Health Officer for the local health department. Note: Authority cited: Sections 100180, 100275, 101160, 120125 and 120130, Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1281 and 1285, Business and Professions Code; and Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.50. Health Officer and Local Health Officer. "Health Officer and Local Health Officer" means the officer appointed by the local governing body (county, city, and district), as defined in Section 2500. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.55. HIV/AIDS Case Report. "HIV/AIDS Case Report" means California Department of Health Services HIV/AIDS Confidential Case Report form, Adult (DHS 8641A (9/01) or Pediatric (DHS 8641P (9/01), hereby incorporated by reference in this Article and available from the local health department or the Department. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.60. Laboratory. "Laboratory" means a 'clinical laboratory,' a 'physician office laboratory,' or a 'public health laboratory,' as defined in Business and Professions Code, Section 1206, that is authorized to perform clinical laboratory tests or examinations in California, or a clinical laboratory located outside of the State of California that is licensed pursuant to Business and Professions Code Section 1241(a) and that tests specimens originating in California. Note: Authority cited: Sections 1224 and 1288, Business and Professions Code; and Sections 100180, 100275, 101160, 120125 and 120130, Health and Safety Code. Reference: Sections 1206, 1220, 1241, 1265 and 1281, Business and Professions Code. s 2641.65. Laboratory Test. "Laboratory test" means a clinical laboratory test or examination as defined in Business and Professions Code, Section 1206(a)(4) and performed by a laboratory as defined in this Article. Note: Authority cited: Sections 1224 and 1288, Business and Professions Code; and Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 1202.5 and 1206, Business and Professions Code; and Section 101160, Health and Safety Code. s 2641.70. Local Health Department. "Local health department" means the governing body providing public health services to cities and/or counties, as identified in Health and Safety Code, Section 101185. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.75. Non-Name Code. "Non-Name Code" means a designation required by Section 2643.5 of this Article, that does not readily identify an HIV-infected individual. Components of the Non-Name Code shall be listed in the following order, and shall consist of an individual's: (a) Soundex code; (b) complete date of birth (2-digit month, 2-digit day, 4-digit year); (c) gender (male [1], female [2], transgender male-to-female [3], or transgender female-to-male [4]); and (d) last four digits of the Social Security Number (if not available, use four digits of zero). Note: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.77. Partial Non-Name Code. A Partial Non-Name Code means a designation required by Section 2643.10 of this Article, that does not readily identify the HIV-infected individual. Components of the Partial Non-Name Code shall be listed in the following order, and shall consist of an individual's: (a) Soundex code; (b) complete date of birth (2-digit month, 2-digit day, 4-digit year) and; (c) gender (male [1], female [2], transgender male-to-female [3], or transgender female-to-male [4]). Note: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140 Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.80. Personal Information. "Personal information" means an individual's complete Social Security Number, complete name or surname, home address, California driver's license or identification number, electronic mail address or telephone number. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.85. Publicly-Funded Confidential Counseling and Testing Program. "Publicly-funded Confidential Counseling and Testing Program" means a program financed by federal, state or local governmental agencies that provides confidential HIV tests to patients. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2641.90. Soundex Code. "Soundex code" means a phonetic, alphanumerical formula which is used to convert the first letter and sequential consonants of an individual's surname into an algorithm. The Soundex code instructions are identified by the Department as form DHS 8641 SC (9/01), hereby incorporated by reference in this Article. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2643.5. HIV Reporting by Health Care Providers. (a) Each health care provider that orders a laboratory test used to identify HIV, a component of HIV, or antibodies to or antigens of HIV shall submit the following to the laboratory performing the test: (1) A pre-printed laboratory requisition form which includes all documentation as specified in 42 CFR 493.1105 (57 FR 7162, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993) and adopted in Business and Professions Code, Section 1220, or; (2) A completed Department of Health Services Counseling and Testing Program Confidential HIV Antibody Test laboratory requisition form, DHS 8257C (1/02), hereby incorporated by reference in this Article. (b) The person authorized to order the laboratory test shall include the following when submitting information to the laboratory: (1) Patient surname; and (2) Patient date of birth (2-digit month, 2-digit day, 4-digit year); and (3) Patient gender (male, female, transgender male-to-female, or transgender female-to-male); and (4) Date biological specimen was collected; and (5) Name, address, telephone number of the health care provider and the facility where services were rendered, if different. (c) Each health care provider shall, within seven calendar days of receipt of a patient's confirmed HIV test and Partial Non-Name Code from a laboratory, complete the Non-Name Code (as specified in Section 2641.75) and report the confirmed HIV test to the local Health Officer for the jurisdiction where the health care provider facility is located. The report shall consist of a completed copy of the HIV/AIDS Case Report form. (d) HIV reporting by Non-Name Code to the local Health Officer, via submission of the HIV/AIDS Case Report, shall not supplant the reporting requirements in Article 1 of this Subchapter when a patient's medical condition progresses from HIV infection to an Acquired Immunodeficiency Syndrome (AIDS) diagnosis. (e) When reporting a confirmed HIV test, a health care provider shall not report a patient's personal information to the local Health Officer except for patients whose clinical conditions meet the AIDS reporting criteria, as specified in Article 1 of this Subchapter. (f) A health care provider who receives notification from an out-of-state laboratory of a confirmed HIV test for a California patient shall report the findings to the local Health Officer for the jurisdiction where the health care provider facility is located. (g) When a health care provider orders multiple HIV-related viral load tests for a patient, or receives multiple laboratory reports of a confirmed HIV test, the health care provider shall be required to submit only one HIV/AIDS Case Report, per patient, to the local Health Officer. (h) For all HIV-infected patients without an AIDS diagnosis, the health care provider shall maintain a system which cross-references patient data by using either the Partial Non-Name Code or the Non-Name Code. This system shall be used only to exchange information with the Local Health Officer in order to complete or unduplicate the HIV case reports. (i) Information reported pursuant to this Article is acquired in confidence and shall not be disclosed by the health care provider except as authorized by this Article, other state or federal law, or with the written consent of the individual to whom the information pertains or the legal representative of that individual. Note: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140, Health and Safety Code. Reference: Sections 1202.5, 1206, 1206.5, 1220, 1241, 1265 and 1281, Business and Professions Code; and Sections 100180, 101160, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2643.10. HIV Reporting by Laboratories. (a) The laboratory director or authorized designee shall create a Partial Non-Name Code (as specified in Section 2641.77) for each confirmed HIV test. (b) The laboratory director or authorized designee shall, within seven calendar days of determining a confirmed HIV test, report the confirmed HIV test to the Health Officer of the local health jurisdiction where the health care provider facility is located. The report shall include the: (1) Partial Non-Name Code of the patient; and (2) Name, address, and telephone number of the health care provider and the facility that submitted the biological specimen to the laboratory, if different.; and (3) Name, address, and telephone number of the laboratory; and (4) Laboratory report number as assigned by the laboratory; and (5) Laboratory results of the test performed; and (6) Date the biological specimen was tested in the laboratory. (c) A laboratory shall not transmit a patient's personal information to the local health department. (d) A laboratory that receives incomplete patient data from a health care provider for a biological specimen with a confirmed HIV test, shall contact the submitting health care provider to obtain the information required pursuant to Section 2643.5(b)(1)-(5), prior to reporting the confirmed HIV test to the local Health Officer. (e) A laboratory shall convey the patient's Partial Non-Name Code to the submitting health care provider when reporting confirmed HIV test results. (f) If a laboratory transfers a biological specimen to another laboratory for testing, the laboratory that first receives the biological specimen from the health care provider shall report confirmed HIV tests to the local Health Officer. (g) Laboratories shall not submit reports to the local health department for confirmed HIV tests for patients of an Alternative Testing Site or other anonymous HIV testing program, a blood bank, a plasma center, or for participants of a blinded and/or unlinked seroprevalence study. (h) When a California laboratory receives a biological specimen for testing from an out-of-state laboratory or health care provider, the California director of the laboratory shall ensure that a confirmed HIV test is reported to the state health department in the state where the biological specimen originated. (i) When a California laboratory receives a report from an out of state laboratory that indicates evidence of a confirmed HIV test for a California patient, the California laboratory shall notify the local Health Officer and health care provider in the same manner as if the findings had been made by the California laboratory. (j) Information reported pursuant to this Article is acquired in confidence and shall not be disclosed by the laboratory except as authorized by this Article, other state or federal law, or with the written consent of the individual to whom the information pertains or the legal representative of the individual. Note: Authority cited: Section 1224, Business and Professions Code; and Sections 100180, 100275, 120125, 120130 and 120140, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241, 1265, 1281 and 1288, Business and Professions Code; and Sections 100180, 101150, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2643.15. HIV Reporting by Local Health Officers. (a) The local Health Officer or his or her authorized designee shall match and unduplicate laboratory reports of confirmed HIV tests with the local health department HIV/AIDS registry database and with HIV/AIDS Case Reports received from health care providers and not entered into the database. (b) The Health Officer or his or her authorized designee shall, within 45 calendar days of receipt of a laboratory report of a confirmed HIV test, submit unduplicated HIV/AIDS Case Reports to the Department. (1) HIV/AIDS Case Reports shall be sent by courier service, U.S. Postal Service Express or Registered mail, or other traceable mail to the California Department of Health Services, Office of AIDS, HIV/AIDS Case Registry. (2) The local Health Officer or his or her authorized designee shall not report confirmed HIV tests for patients of an Alternative Testing Site or other anonymous counseling and testing program, a blood bank, a plasma center, or for participants of a blinded and/or unlinked HIV seroprevalence study. (c) The local Health Officer or his or her authorized designee shall not submit an HIV/AIDS Case Report to the Department for an infant under the age of 18 months, unless the infant's HIV infection is confirmed. (d) Information reported pursuant to this Article is acquired in confidence and shall not be disclosed by the local Health Officer or his or her authorized designee except as authorized by this Article, other state or federal law, or with the written consent of the individual to whom the information pertains or the legal representative of the individual. Note: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2643.20. HIV Reporting Exemptions. Alternative Testing Sites; other anonymous or unlinked HIV testing programs; blood banks; plasma centers; and blinded and/or unlinked seroprevalence studies are exempt from these HIV reporting regulations. Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code. s 2650. Canine Rabies Vaccine Advisory Committee. The Director shall appoint a Canine Rabies Vaccine Advisory Committee consisting of 6 to 8 members. The Committee's responsibility shall be to assist the Department in evaluating the effectiveness of canine rabies vaccines. Membership shall include individuals with recognized professional expertise in at least one of the fields of immunology, virology, epidemiology, public health and veterinary medicine. Committee members shall serve without compensation but shall be reimbursed for actual and necessary expenses incurred during service on the committee. Canine rabies vaccines that have been approved by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, shall be evaluated for the degree of effectiveness by the Canine Rabies Vaccine Advisory Committee. In order to evaluate vaccine effectiveness the committee shall: (a) Review test data submitted by canine rabies vaccine manufacturing firms, for approval of canine rabies vaccines. (b) Make recommendations for Departmental approval or disapproval of canine rabies vaccines. (c) Make recommendations concerning approval of any variances from the established standards for acceptance of canine rabies vaccines. Note: Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code. s 2651. Approval of Canine Rabies Vaccines. (a) In order for a canine rabies vaccine to be approved for use in California, it shall adhere to the following requirements: (1) Meet Animal and Plant Health Inspection Service (APHIS) standards for sterility and safety. Evidence of product conformance to APHIS Standards will be demonstrated by the United States Department of Agriculture (USDA) product licensing; and (2) If an inactivated vaccine, it shall have a minimal relative potency (RP) at vaccination of at least 2.0 as determined by the National Institute of Health (NIH)Test for potency or if a modified live virus (MLV) vaccine it shall meet USDA potency Requirements; and (3) Demonstrate an immunity duration of three or more years based on an immunity duration challenge study conducted in conformity with section 2652; and (4) Comply with the origin and integrity of Rabies Vaccine Virus Requirements in section 2653. Note: Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code. s 2652. Immunity Duration-Challenge Studies. (a) The demonstration of an acceptable immunity duration of three or more years, as shown by adequate challenge studies in dogs, shall be required. However, the above challenge study shall not suffice for acceptance of a subsequent multiple vaccine product that contains the same rabies vaccine as one of two or more component vaccines. (b) Vaccine Trial Protocols. Vaccine trial protocols shall be submitted to the Department by vaccine manufacturers prior to beginning the immunity duration challenge study. The protocol shall include animals, materials, methods and procedures. The protocol shall include the identification number of each animal, its source and/or that of its mother, if applicable, sex, age, breed and the name, address, and telephone number of a contact person who can verify personal knowledge of the dog's vaccination history. Annual progress reports and a final report of the immunity-duration challenge study shall be submitted to the Department. The reports shall include by date for each dog its rabies antibody titers, other immunizations, medications, illnesses, unusual events and death, if applicable, as well as any changes or developments in reference to animals, materials, methods, and procedures. The Department shall supply firms with an outline to report the foregoing information. The outline will include the following items: (1) "Protocol for Proposed Rabies Vaccine Immunity Duration Challenge Study"; (2) "Procedures and Preliminary Data Attending Initiation of Canine Rabies Vaccine Immunity Duration Challenge Study"; (3) "Progress Report: One Year Postvaccination"; (4) "Progress Report: Two Years Postvaccination"; (5) "Final Report"; (6) "Results of Challenge"; and (7) "Progress Report for Three Years Postvaccination." The Veterinary Public Health Unit, 714 P Street, Room 760, Sacramento, California 95814 will provide this outline upon request. (c) Dogs Used in Studies. No pound dogs or other dogs of undeterminable rabies vaccination history shall be used in the study. Dogs shall be obtained from the original owner since birth or have verifiable histories. Groups of vaccinates and control dogs shall be of approximately equal composition, according to numbers, sex ratio (approximately 50:50), age, and origin. As much as is possible, dogs of uniform size or conformation shall be used. No dog shall be used which has had prior rabies immunization or which has detectable serum rabies neutralizing antibodies. Dogs under 8 months of age used in studies shall not originate from rabies-immunized mothers. No dog shall be over 1 1/2 years of age at vaccination or when set aside as a control. (d) Size of Challenge Groups. Challenge groups, both vaccinates and nonimmunized controls, shall each consist of 30 or more dogs at challenge. Any additional (extra or back-up) dogs, intended to replace vaccinates or controls that die prior to challenge, shall be included in either the vaccinate or the control group prior to the initiation of the study and subsequently treated, sampled and reported on as either a vaccinate dog or as a control dog. The use of additional sets of vaccinate and/or control dogs to be challenged simultaneously, or at an earlier or later date, shall not be recognized as representative of separate trials. Instead, the serological results subsequent to vaccination and the reactions to challenge of all groups, sets, and individual dogs shall be included in the overall analysis on a cumulative basis. Failed antibody response or failed reaction to challenge at any time shall disqualify subsequent trial phases. (e) Route and Site of Vaccination. MLV vaccines shall be inoculated intramuscularly at one site in the thigh. Inactivated vaccines may be inoculated by any single route and single site which provides the required protection against challenge at least 3 years post vaccination and is shown to be safe. The exact site and route of inoculation shall be described. (f) New Route and/or Site of Vaccination. If a firm changes its recommended route and/or site of vaccination of a previously approved vaccine, the vaccine shall be tested as a new product, and the firm shall complete another satisfactory immunity duration-challenge study of 3 years or greater duration before the new route and/or site of vaccination shall be approved. (g) Additional Vaccinations. Excepting food and water, no vaccinate or control dog shall be exposed to any vaccine, drug, or other substance by any route within three weeks prior to any bleeding for antibody test or within three weeks prior to or at any time after challenge with rabies virus except at euthanasia. (h) Serology. Standard serum virus-neutralization tests done in mice (MSNT) or the rapid rabies fluorescent focus inhibition test (RFFIT) shall be used in comparing the immunogenicity of different products. No substitute test reagents or substitute tests shall be accepted. (1) Test results shall be reported for the vaccinate group and controls. Serum virus-neutralization titrations shall be performed on sera of (1) all dogs prior to vaccination; (2) vaccinates at the end of post vaccination months 1, 3, 6, 9, 12, 18, 24, 30 and 36 just prior to challenge; (3) controls at the end of month 36 just prior to challenge; and (4) survivors just prior to euthanasia. (2) At years post vaccination, all vaccinate dogs shall have demonstrable serum rabies antibody titers, the median titer being equal to, or greater than, 1:15 by the MSNT or an equivalent test. (3) At 3 years post vaccination, at least 90 per cent of vaccinates shall have demonstrable titers by the MSNT, the median titer being equal to, or greater than, 1:10 by the MSNT or an equivalent test. (i) Incidental Deaths or Deletions. There shall be a complete accounting for all dogs used in the study, including any that die or are killed after the start of the study or any withdrawn from participation for any reason. Each such dog shall be accounted for by dates and details of illness, treatment and death, the cause of death with supportive diagnostic test results, and rabies serology records. Each such dog shall be tested for rabies infection by Fluorescent Rabies Antibody (FRA) test followed by the mouse inoculation test if the FRA test is negative. (j) Challenge Virus and Dose. The challenge virus inoculum shall be infective carnivore salivary gland suspension supernate of a North American carnivore "street" rabies virus. The dose of challenge virus given shall be estimated by titration prior to challenge and confirmed by titration of residual challenge inoculum. The dose of challenge virus shall be as low as possible while still achieving a mortality of 80 - 100 per cent in controls. The dose given each dog shall not exceed 200,000 mouse intracranial 50 percent lethal doses (MICLD50), or a demonstrably equivalent dose as determined by an alternate method of titration. (k) Challenge Route and Procedure. Only challenge virus inoculum shall be inoculated into the masseter muscles of vaccinate dogs or control dogs at any time. Challenge virus shall be inoculated intramuscularly into the masseter muscles, the viral dose being divided into two equal parts for bilateral inoculation. Should a challenge route or site other than the intramasseter route be used, the firm employing the route or site shall demonstrate in a trial previously approved by the Department, the effectiveness and appropriateness of the post challenge holding period and compensate for any related increase in incubation period and decrease in susceptibility. All animals, vaccinates and controls, shall be challenged at the same time, either on an alternate basis (i.e., a vaccinate, followed by a control, followed by a vaccinate, etc.) or the vaccinates shall be challenged first and the controls challenged immediately afterwards. A separate needle and a separate syringe shall be used for each dog. (l) Individual Enclosure for Each Challenged Dog. Each dog shall be kept in an individual enclosure, preventing its contact with any other animal. (m) Post challenge Observation Period. Challenged dogs, retained in isolation, shall be observed for a minimum of 90 days prior to final bleeding, euthanasia, and rabies testing of their brains. (n) Mortality in Challenged Animals. With rare exceptions, all vaccinates shall survive challenge. Eighty to one hundred percent of challenged controls shall die of rabies. (o) Confirmatory Rabies Diagnostic Tests on Brains of Dogs that Die and on Brains of Survivors. Brains of dogs that die and brains of dogs that survive challenge shall be tested by fluorescent rabies antibody (FRA) test, followed by mouse-inoculation test if the former is negative; dead mice shall be confirmed as rabies-infected by FRA test on their brains. Dogs that die at any time following administration of a live virus vaccine shall be tested for possible rabies vaccine virus infection, using tests suitable to disclose, recover, and identify the strain of vaccine virus. Note: Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code. s 2653. Origin and Integrity of Rabies Vaccine Virus. The Department shall be provided with comprehensive information on the origin, passage level, and sub-passage history of rabies viruses used in the development and production of rabies vaccines being submitted for approval. The integrity of the rabies virus used in the production of the vaccine shall be maintained without further modification once the vaccine is approved for use in the Department's rabies control program. Note: Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code. s 2800. Activities of Daily Living. "Activities of daily living" means bathing, dressing, feeding oneself, brushing one's teeth, and performing more complex tasks such as grocery shopping, cooking, management of personal finances, and operating a motor vehicle. Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code. s 2802. Alzheimer's Disease and Related Disorders. "Alzheimer's disease and related disorders" means those illnesses that damage the brain causing irreversible, progressive confusion, disorientation, loss of memory and judgment. Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code. s 2804. Diagnose. "Diagnose" means to identify the existence of a medical condition in a patient. Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code. s 2806. Disorders Characterized by Lapses of Consciousness. (a) "Disorders characterized by lapses of consciousness" means those medical conditions that involve: (1) a loss of consciousness or a marked reduction of alertness or responsiveness to external stimuli; and (2) the inability to perform one or more activities of daily living; and (3) the impairment of the sensory motor functions used to operate a motor vehicle. (b) Examples of medical conditions that do not always, but may progress to the level of functional severity described in subsection (a) of this section include Alzheimer's disease and related disorders, seizure disorders, brain tumors, narcolepsy, sleep apnea, and abnormal metabolic states, including hypo-and hyperglycemia associated with diabetes. Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code. s 2808. Sensory Motor Functions. "Sensory motor functions" means the ability to integrate seeing, hearing, smelling, feeling, and reacting with physical movement, such as depressing the brake pedal of the car to stop the car from entering an intersection with a green traffic light to avoid hitting a pedestrian crossing the street. Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code. s 2810. Reporting Requirements. (a) Except as provided in Section 2812, a physician and surgeon shall notify the local health officer within seven (7) calendar days of every patient 14 years of age or older, when a physician and surgeon has diagnosed a disorder characterized by lapses of consciousness (as defined in Section 2806) in a patient. (b) The report prepared pursuant to subsection (a) of this section shall include: (1) The name, address, date of birth, and diagnosis of the patient; and (2) The name, address, and phone number of the physician and surgeon making the report. Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code. s 2812. Exceptions to Reporting. A physician and surgeon shall not be required to notify the local health officer of a patient with a disorder characterized by lapses of consciousness if: (a) The patient's sensory motor functions are impaired to the extent that the patient is unable to ever operate a motor vehicle, or (b) The patient states that he or she does not drive and states that he or she never intends to drive, and the physician and surgeon believes these statements made by the patient are true, or (c) The physician and surgeon previously reported the diagnosis and, since that report, the physician and surgeon believes the patient has not operated a motor vehicle, or (d) There is documentation in the patient's medical record that another physician and surgeon reported the diagnosis and, since that report, the physician and surgeon believes the patient has not operated a motor vehicle. Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code. s 2890. Confidential Nature of Crippled Children's Records. Note: Authority cited: Sections 208, 249, 268, and 271, Health and Safety Code. s 2900. Case Finding and Reporting. Note: Authority cited for s 2900 to 2904, inclusive: Sections 208 and 249, Health and Safety Code. s 2901. Definition. Note: Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code. s 2902. Records and Reports. s 2903. Diagnostic Services. Note: Additional authority cited: Section 1509, Health and Safety Code. s 2904. Treatment. s 2905. After-Care Services. s 2906. Authorization for Services. Note: Authority cited: Sections 102 and 208, Health and Safety Code, Reference: Art. 2, Ch. 2, Pt. 1, Div. 1, Health and Safety Code. s 2907. Bone Marrow Transplantation for Cancer. Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Section 273, Health and Safety Code. s 2910. Program Administration. Note: Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code. s 2912. Use of Fund. Note: Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code. s 2914. Extensive Medical Care. Note: Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code. s 2920. California Children Services (CCS). Note: Authority cited: Section 208 (a), Health and Safety Code. Reference: Section 255.5 and 255.6, Health and Safety Code. s 2921. California Children Services (CCS) Panel. Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Sections 255.5 and 255.6, Health and Safety Code. s 2922. Expertise in the Care of Children. Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Section 255.6, Health and Safety Code. s 2923. General Supervision. Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Section 255.5, 262 and 268, Health and Safety Code. s 2930. Genetically Handicapped Persons Program. The Genetically Handicapped Persons Program (GHPP) is a health care program within the California Children Services (CCS) Branch which provides medical care and other related services for persons with the genetically handicapping conditions specified in Section 2932 of this chapter. Note: Authority cited: Sections 208(a) and 341, Health and Safety Code. Reference: Section 341, Health and Safety Code. s 2931. California Children Services/Genetically Handicapped Persons Program Special Care Center. (a) A California Children Services (CCS)/Genetically Handicapped Persons Program (GHPP) Special Care Center is a medical center which provides diagnostic and treatment services (inpatient, outpatient and home) to CCS clients under 21 years of age who have GHPP eligible conditions, and to GHPP clients over 21 years of age. (b) California Children Services/Genetically Handicapped Persons Program Special Care Centers include the following: (1) Hemophilia Center (2) Cystic Fibrosis Center (3) Sickle Cell Disease Center (4) Specified Inherited Neurologic Disease Center (5) Amniocentesis Center (6) Metabolic Disease Center Note: Authority cited: Sections 208(a) and 341, Health and Safety Code. Reference: Sections 340, 341 and 342, Health and Safety Code. s 2932. Medical Eligibility -Conditions. (a) The following medical conditions are eligible for services through the GHPP program: (1) Hemophilia, which includes any congenital hereditary hemorrhagic state due to a defect in the hemostatic mechanism resulting from a deficiency or abnormality in one of the plasma clotting factors or platelets including: (A) Factor I deficiency (B) Factor II deficiency (C) Factor V deficiency (D) Factor VII deficiency (E) Factor VIII deficiency (F) Factor IX deficiency (G) Factor X deficiency (H) Factor XI deficiency (I) Factor XIII deficiency (J) von Willebrand's Disease (K) Congenital hereditary platelet deficiency diseases or dysfunction such as congenital thrombasthenia (Glanzman's thrombasthenia) and thrombocytopathia (2) Cystic fibrosis (3) Hemoglobinopathies with anemia including: (A) Sickle Cell Disease, but not sickle cell trait (B) Thalassemia (4) Chronic degenerative neurological diseases: (A) Huntington's Disease (B) Joseph's Disease (C) Friedreich's Ataxia, genetic ataxias due to spinocerebellar degeneration. 1. Hereditary spastic paraplegia 2. Roussy-Levy Syndrome 3. Olivopontocerebellar degeneration 4. Refsum's disease 5. Charcot-Marie-Tooth Syndrome (5) The following metabolic diseases: (A) Disorder of amino-acid transport and metabolism 1. Phenylketonuria 2. Other disturbances of armoatic amino-acid metabolism a. Tyrosinemia 3. Disturbances of branched chain amino-acid metabolism a. Disturbances of metabolism of leucine, isoleucine, valine b. Hypervalinemia c. Intermittent branched-chain ketonuria d. Leucine-induced hypoglycemia e. Leucinosis f. Maple syrup urine disease g. Propionic and methylmalonic acidemias h. Lactic and pyruvate metabolism disorders i. Hereditary orotic (pyrimidine acidemia) 4. Disturbances of sulphur bearing amino-acid metabolism a. Homocystinuria b. Hypermethioninemia 5. Urea cycle disorders a. Argininosuccinic aciduria b. Citrullinemia c. Disorders of metabolism of ornithine, citrulline, argininossuccinic acid, arginine, and ammonia d. Hyperammonemia e. Hyperornithinemia (B) Disorders of carbohydrate transport and metabolism 1. Galactosemia a. Galactose-1-phosphate uridyl transferase deficiency b. Galactosuria (C) Disorders of copper metabolism 1. Wilson's disease Note: Authority cited: Sections 208(a) and 341, Health and Safety Code. Reference: Sections 341 and 341.5, Health and Safety Code. s 2950. Qualifications. The qualifications required for registration as school audiometrist shall be as follows: (a) Satisfactory completion of required training in audiology, audiometry and hearing assessment at an accredited university or college. Such training must include a minimum of eight quarter hours, or equivalent, academic and practical preparation in audiology, identification audiometry and hearing assessment in courses approved by the Hearing Conservation Specialist of the State Department of Health Services. If the applicant completed the required training more than five years prior to the date of application for registration, the applicant must have had at least one year of verified supervised experience in the interim in the administration of hearing tests to school children in the public or parochial schools, or in other tax maintained educational institutions in this State. Verification will be documented in writing by the applicant's supervisor. (b) Public health nurses and credentialed school nurses may either fulfill the requirements of subsection (a) or demonstrate satisfactory completion, at an accredited university or college, of a four quarter hours, or equivalent, hearing assessment course approved by the Hearing Conservation Specialist of the Department of Health Services. (c) For purposes of subsections (a) and (b) accreditation of colleges or universities shall be by one of the following accrediting associations: (1) New England Association of School and Colleges. (2) Middle States Association of Colleges and Secondary Schools. (3) North Central Association of Colleges and Secondary Schools. (4) Northern Association of Schools and Colleges. (5) Southern Association of Colleges and Schools. (6) Western Association of Schools and Colleges. (d) Applicants for registration as school audiometrists shall complete State Form Application for Registration as School Audiometrist PM 101 and submit the completed form to the State Department of Health Services, 714 P Street, Sacramento, CA 95814. (e) A registration fee of $10.00 shall accompany each application. (f) An applicant for registration as school audiometrist shall receive written notification informing the applicant that the application is complete and approved, or that the application is deficient and what specific information is required. Notification must occur within two weeks of receipt of the application by the State Department of Health Services. This two week time period is a median based on a minimum of one week and maximum of three weeks actual performance in 1985 and 1986. (g) Within four weeks of receipt of an approved application, the State Department of Health Services shall issue a certification of registration to the applicant. Note: Authority cited: Sections 208 and 1686, Health and Safety Code. Reference: Sections 1685 and 1686, Health and Safety Code; and Section 44879, Education Code, and Section 15374 et seq., Government Code. s 2951. Testing Standards. Schools conducting hearing testing shall comply with the following criteria: (a) Equipment. (1) Hearing threshold tests. (A) Pure tone audiometers used for testing of hearing thresholds shall be those manufactured to meet or exceed specifications for wide range or limited range audiometers as defined by American National Standards Institute (ANSI) Specification Section 3.6-1969, Subsection 2.1.1 (published in 1969) and shall be maintained to meet such specifications. Such audiometers shall be designed to operate from alternating current supply voltages and meet the stability standards defined in Subsection 4.6 of American National Standards Institute (ANSI) Section 3.6-1969 Specifications. (2) Hearing screening test. (A) Pure tone audiometers used for hearing screening tests shall be those manufactured to meet or exceed specifications for wide range audiometers or limited range audiometers as defined by the American National Standards Institute (ANSI) Section 3.6-1969, Subsections 2.1.1 and 2.1.2 and shall be maintained to meet such specifications. (B) Pure tone audiometers used for hearing screening tests shall not be battery powered. Audiometers in use on the effective date of the amendment to the regulations may be utilized until they no longer meet American National Standards Institute (ANSI) Section 3.6-1969 Specifications, Subsections 1 through 4.9.2. (3) Care of equipment. (A) Audiometric testing personnel shall be trained in the proper care of the testing equipment. (B) Biological checks. Audiometric testing personnel shall maintain continuous surveillance of the audiometer used, by performing biological checks as follows: 1. Daily. A brief biological check of the audiometer shall be made each day the audiometer is in use. The check shall consist of testing each earphone on a person with stable audiometric thresholds that do not exceed 25 decibel hearing level at any frequency tested between 500 Hertz and 4000 Hertz and comparing the test results with the subject's baseline audiogram. The subject may be the audiometrist. 2. Monthly. A detailed biological check of the audiometer which includes a careful listening test of earphones to insure that the audiometer displays no evidence of a. Cross talk; b. Signal distortion; c. Transient clicks; d. Abnormal noise; or, e. Intermittent signal. (C) Calibration. 1. An electroacoustic calibration check of audiometers shall be made at least every 12 months, or more frequently if indicated by the biological checks, and meet or exceed the specifications outlined in Subsections 1 through 4.9.2., American National Standards for Audiometers, published by the American National Standards Institute (ANSI), Inc. (published in 1969). 2. A calibration chart, showing proof of performance, shall be kept with the audiometer. (b) Test environment. (1) For audiometric threshold testing and screening testing, the environmental noise level shall not exceed 41.5 decibel sound pressure level in the 500 Hertz band, 49.5 decibel sound pressure level in the 1000 Hertz band, and 54.5 decibel sound pressure level in the 2000 Hertz band, and 62 decibel sound pressure level in the 4000 Hertz band; or, (2) The test environment shall be considered adequate if the noise levels do not cause a threshold shift greater than 10 decibels at those frequencies which must be included in a pure tone conduction threshold test. This procedure may be performed on the audiometris. (c) Testing procedures. (1) Each pupil shall be given a hearing screening test in kindergarten or first grade and in second, fifth, eighth, tenth or eleventh grade and first entry into the California public school system. (A) A school district may request a waiver of the hearing screening test for tenth and/or eleventh grade pupils once each school year. The request for a waiver must be in writing and addressed to the State Department of Health Services, Hearing Conservation Specialist. The waiver request must include the dates of the school year for which the waiver is requested and an alternative testing plan that will insure that each pupil at risk of hearing loss will receive testing services. Pupils at risk of hearing loss are: those exposed to loud noises, including loud music; pupils that have been referred for testing by a parent or teacher; repeat tests for those pupils for whom there was a previously documented problem, pupils who have not had a hearing test for three years; and any pupil who has enrolled for the first time in the school district. An approved waiver of the hearing screening test does not exempt a school district from reporting requirements contained in Section 2951, (e). (B) Each pupil enrolled in a special education program (as described in Section 56001 of the Education Code), other than those pupils enrolled for a hearing problem, shall be given a hearing test when enrolled in the program and every third year thereafter. Hearing tests may be given more frequently as needed, based on the individual education program team's evaluation of each individual pupil. (2) Pure tone audiometric screening tests shall be conducted at a level not to exceed 25 decibels and shall include the frequencies 1000, 2000 and 4000 Hertz. A pupil's failure to respond to any of the required frequencies constitutes a failure of the screening test. Individual tests may be used for pupils of all ages. Group tests may only be used for pupils who demonstrate reliable results. (3) Pure tone air conduction threshold tests shall include the frequencies 500, 1000, 2000 and 4000 Hertz and shall be given to: (A) All pupils who fail the screening tests; (B) All pupils who are to be considered for further audiological or otological evaluation. (d) Referral. The schools shall provide the parents or guardians of children who fail the hearing tests with a written notification of the test results and recommend that a medical and audiological evaluation be obtained whenever the test demonstrates: (1) A hearing level of 30 decibels or greater for two or more frequencies in an ear at 500, 1000, 2000 or 4000 Hertz, or a hearing level of 40 decibels or greater for one of the frequencies tested, 500 through 4000 Hertz, on two threshold tests completed at an interval of at least two weeks; or (2) There is evidence of pathology, such as an infection of the outer ear, chronic drainage, or a chronic earache. (e) Reporting results. (1) Dates and results of all screening hearing testing shall be recorded on each pupil's health record. Copies of all threshold tests shall be filed with the pupil's health records. (2) Each school shall prepare an annual report of the school hearing testing program using Annual Report of Hearing Testing forms, PM 100, provided by the State Department of Health Services with copies to the district superintendent and the county superintendent of schools. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 1685 and 1686, Health and Safety Code; and Sections 44879 and 56001, Education Code. s 3000.2. Botulism Immune Globulin. "Botulism Immune Globulin" or "BIG" means the pharmaceutical product which consists of human-derived or human-gene-derived immunoglobulin (antibody) molecules or active fragments thereof and appropriate stabilizing agents that possesses the ability to neutralize botulinum or botulinum-like toxins. Note: Authority cited: Section 123707(c), Health and Safety Code. Reference: Sections 123700-123709, Health and Safety Code. s 3000.4. Infant Botulism Treatment and Prevention Program. "Infant Botulism Treatment and Prevention Program" or "IBTPP" means the unit of the California Department of Health Services mandated by Health & Safety Code Section 123702. Note: Authority cited: Section 123707(c), Health and Safety Code. Reference: Sections 123700-123709, Health and Safety Code. s 3010. Distribution of Botulism Immune Globulin. Only patients admitted to and treated in hospitals located in the United States, its territories and possessions, and the federal Centers for Disease Control and Prevention (CDC) shall be eligible recipients for the distribution of BIG. Note: Authority cited: Section 123707(c), Health and Safety Code. Reference: Sections 123702, 123704(b), (c), (g) and 123705, Health and Safety Code. s 3020. Reporting Requirements for Hospitals. Within one week of discharge, the patient's hospital shall provide to the IBTPP the following information on the patient treated with BIG: (a) Admission and discharge summaries, and (b) A listing of hospital charges, costs, and reimbursements for the patient's hospital stay. Note: Authority cited: Section 123707(c), Health and Safety Code. Reference: Sections 123704(b), (c), (e), (f) and 123705, Health and Safety Code. s 3030. Fee. The per patient fee for Botulism Immune Globulin shall be $45,300. Note: Authority cited: Section 123707(d), Health and Safety Code. Reference: Sections 123702 and 123705, Health and Safety Code. s 4500. Public Health Nurse Certificate. Note: Authority cited: Sections 208, 600, 602, 1111 and 1130, Health and Safety Code. Reference: Sections 600, 602, 604, 605, 1111 and 1130, Health and Safety Code. s 4501. Qualifications and Requirements. Note: Authority cited: Sections 208, 600, 602, 1111 and 1130, Health and Safety Code. Reference: Sections 600, 602, 604, 605, 1111 and 1130, Health and Safety Code. s 4502. Application for Public Health Nurse Certificate. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 604, Health and Safety Code; and Section 2015.5, Code of Civil Procedure. s 4503. Issuance of Application. Note: Authority cited: Section 15376, Government Code. Reference: Section 15376, Government Code; and Section 1013(a), Code of Civil Procedure. s 4504. Appeal Process. Note: Authority cited: Section 15378, Government Code. Reference: Section 15376 and 15378, Government Code. <<(Subchapter Originally Printed 8-15-45)>> Note: Authority cited for Subchapter 6: Sections 102 and 208, Health and Safety Code. Reference: Sections 3279, 3294, 3298 and 3299, Health and Safety Code. Cross Reference: Sections 2636 (a) to (m), Title 17, Subchapter 1.7, Reportable diseases and Conditions. s 5151. Sexually Transmitted Diseases in Minors. (a) A minor 12 years of age or older may give consent to the furnishing of hospital, medical and surgical care related to the diagnosis and/or treatment of any of the following non-reportable sexually transmissible diseases: (1) Candida genitalis. (2) Chlamydia trachomatous. (3) Condyloma acuminata. (4) Hemophilus vaginalis (Gardnerella vaginale). (5) Cytomegalovirus infection. (6) Herpes genitalis. (7) Molluscum contagiosum. (8) Non-gonococcal urethritis, vaginitis and cervicitis. (9) Pediculosis (Phthirus pubis). (10) Scabies (Sarcoptes scabiei). (11) Trichomoniasis. Note: Authority cited: Section 208 (a), Health and Safety Code; and Section 34.7, Civil Code. Reference: Section 34.7, Civil Code. s 6000. Admission. "Admission" means a pupil's first entry in a given public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center. "Admission" also denotes a pupil's re-entry to one of these institutions after withdrawing from a previous enrollment. (a) "Unconditional admission" is admission based upon documentation of receipt of all required immunizations or upon documentation of a permanent medical exemption or of a personal beliefs exemption to immunization in accordance with Section 6051. (b) "Conditional admission" is admission based upon either documentation of having received some but not all required immunizations and of not being due for any vaccine dose at the time of entry or upon documentation of a temporary medical exemption to immunization in accordance with Section 6050. Continued attendance after conditional admission is contingent upon receipt of the remaining required immunizations in accordance with Sections 6020 and 6035. Note: Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335), 120340, 120365, 120370 and 120375, Health and Safety Code. s 6010. Immunizing Agent. Note: Authority cited: Sections 208 and 3390, Health and Safety Code. Reference: Section 3381, Health and Safety Code. s 6015. Pupil. "Pupil" means a person under age 18 years admitted to or seeking admission to any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center. Note: Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335) and 120360, Health and Safety Code. s 6020. Required Immunizations. (a) The required immunizations for admission to and attendance at a public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or developmental center shall be those set forth, according to age, in Table 1. (b) In Table 1 of Section 6020 and in Table 2 of Section 6035, DTP (or DPT) means diphtheria and tetanus toxoids and pertussis vaccine, including DTaP vaccine. DT (or TD) and Td (or dT) means diphtheria and tetanus toxoids. (c) For pupils who have reached their seventh birthday, a history of any preparations containing both diphtheria and tetanus toxoids (DTP, DT, Td, etc.) shall be acceptable as meeting the requirement for tetanus and diphtheria toxoids that is set forth in Table 1. (d) Pupils who have reached their seventh birthday shall be exempt from the pertussis and mumps immunization requirements. (e) Combination vaccines that include measles, mumps, and rubella components shall be acceptable as meeting the requirements for these vaccines that are set forth in Table 1. (f) For pupils entering or advancing to the seventh grade, immunization requirements are set forth in Table 1. (g) Pupils already admitted to California public and private schools at the Kindergarten level or above before July 1, 2001 are exempt from the Varicella (chickenpox) requirement as set forth in Table 1. Table 1: Immunization Requirements [Note: The following TABLE/FORM is too wide to be displayed on one screen. You must print it for a meaningful review of its contents. The table has been divided into multiple pieces with each piece containing information to help you assemble a printout of the table. The information for each piece includes: (1) a three line message preceding the tabular data showing by line # and character # the position of the upper left-hand corner of the piece and the position of the piece within the entire table; and (2) a numeric scale following the tabular data displaying the character positions.] ******************************************************************************* ******** This is piece 1. -- It begins at character 1 of table line 1. ******** ******************************************************************************* _______________________________________________________________________________ 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70....+.... ******************************************************************************* ******** This is piece 2. -- It begins at character 1 of table line 2. ******** ******************************************************************************* Institution Age Vaccine 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70. ******************************************************************************* ******* This is piece 3. -- It begins at character 72 of table line 2. ******** ******************************************************************************* Total Doses Received 72.....80....+...90....+....0....+...10....+. ******************************************************************************* ******** This is piece 4. -- It begins at character 1 of table line 4. ******** ******************************************************************************* _______________________________________________________________________________ 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70....+.... ******************************************************************************* ******** This is piece 5. -- It begins at character 1 of table line 5. ******** ******************************************************************************* Child care Less than 2 months None center, day nursery, nursery school, family day care home, development center 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70....+.... ******************************************************************************* ******* This is piece 6. -- It begins at character 1 of table line 14. ******** ******************************************************************************* _______________________________________________________________________________ 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70....+.... ******************************************************************************* ******* This is piece 7. -- It begins at character 1 of table line 15. ******** ******************************************************************************* Same as above 2-3 months 1. 2. 3. 4. 1...+...10....+...20....+...30....+...40....+ ******************************************************************************* ******* This is piece 8. -- It begins at character 46 of table line 15. ******* ******************************************************************************* Polio [FN1]......................%W4B 1 dose DTP..............................%W4B 1 dose Hib..............................%W4B 1 dose Hepatitis B......................%W4B 1 dose 46.......+...60....+...70....+...80....+...90....+....0....+...10....+. ******************************************************************************* ******* This is piece 9. -- It begins at character 1 of table line 19. ******** ******************************************************************************* _______________________________________________________________________________ 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70....+.... ******************************************************************************* ******* This is piece 10. -- It begins at character 1 of table line 20. ******* ******************************************************************************* Same as above 4-5 months 2. DTP, or combination of DTP and diphtheria-tetanus Same as above 6-14 months 2. DTP, or combination of DTP and diphtheria-tetanus toxoids.................. 3. Hib................... 4. Hepatitis B........... Same as above 15-17 months 2. DTP, or combination of DTP and diphtheria-tetanus toxoids.................. 3. Measles, rubella, and mumps.................. 4. Hib................... 5. Hepatitis B........... Same as above 18 months-5 years 2. DTP, or combination of DTP and diphtheria-tetanus toxoids.................. 3. Measles, rubella, and mumps.................. 4. Hib [FN3]............. 5. Hepatitis B [FN2]..... 6. Varicella............. Elementary 4-6 years school at kindergarten level and above 2. DTP, or combination of DTP and diphtheria-tetanus toxoids.................. 3. Measles, rubella, and mumps.................. 4. Hepatitis B [FN2]..... 5. Varicella............. Elementary 7-17 years school, secondary school 2. Diphtheria and tetanus toxoids, given as DTP, DT, or Td (pertussis not required).............. 3. Measles and rubella (mumps not required).............. 4. Varicella [FN5]....... 1...+...10....+...20....+...30....+...40.. ******************************************************************************* ****** This is piece 11. -- It begins at character 43 of table line 20. ******* ******************************************************************************* 1. Polio [FN1]......................%W4B 2 doses toxoids.............................%W4B 2 doses 3. Hib.................................. 2 doses ...................................... 4. Hepatitis B......................%W4B 2 doses 1. Polio [FN1]......................%W4B 2 doses ........................................ 3 doses ........................................ 2 doses ........................................ 2 doses 1. Polio [FN1]....... ........................................ 3 doses ........................................ 3 doses ........................................ 1 dose of each separately or combined on or after the 1st birthday ........................................ 1 dose on or after the 1st birthday ........................................ 2 doses 1. Polio [FN1]....... ........................................ 3 doses ........................................ 4 doses ........................................ 1 dose of each separately or combined on or after the 1st birthday ........................................ 1 dose on or after the 1st birthday ........................................ 3 doses ........................................ 1 dose 1. Polio [FN1]....... ........................................ 4 doses, except that a total of 3 doses is acceptable if at least one dose was given on or after the 4th birthday ........................................ 5 doses, except that a total of 4 doses is acceptable if at least one dose was given on or after the 4th birthday. ........................................ 1 dose of each, separately or combined, on or after the 1st birthday. Pupils entering a kindergarten (or first grade if kindergarten skipped) are required to have 2 doses of measles-containi- ng vaccine, both given on or after the first birthday ........................................ 3 doses ........................................ 1 dose 1. Polio [FN1]....... ........................................ 4 doses, except that a total of 3 doses is acceptable if at least one dose was given on or after the 2nd birthday At least 3 doses. One Td dose is more required if the last dose was given before the 2nd birthday. (See below for additional recommendations for 7th grade enrollment, effective 7/1/99.) 1 dose of each, or combined, on separately or after the 1st birthday. (See below for additional requirements for 7th grade enrollment, effective 7/1/99.) ........................................ 1 dose aged 7 through 12 years for students not admitted to California schools before July 1, 2001. 2 doses for students aged 13 through 17 years not admitted to California schools before July 1, 2001. 43....50....+...60....+...70....+...80....+...90....+....0....+...10....+. ******************************************************************************* ****** This is piece 12. -- It begins at character 1 of table line 156. ******* ******************************************************************************* _______________________________________________________________________________ 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70....+.... ******************************************************************************* ****** This is piece 13. -- It begins at character 1 of table line 157. ******* ******************************************************************************* Seventh Grade Any [FN4] 2. Measles............... ------------------------ 1...+...10....+...20....+...30....+...40.. ******************************************************************************* ****** This is piece 14. -- It begins at character 43 of table line 157. ****** ******************************************************************************* 1. Hepatitis B....... ........................................ 3 doses ........................................ 2 doses of measles -containing vaccine, both given on or after the first birthday. --------------------- -- Recommended but not One Td dose is required: Tetanus-diphtheria, more have elapsed since the 43....50....+...60....+...70....+...80....+...90....+....0....+...10....+. ******************************************************************************* ****** This is piece 15. -- It begins at character 1 of table line 173. ******* ******************************************************************************* _______________________________________________________________________________ 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70....+.... ******************************************************************************* ****** This is piece 16. -- It begins at character 1 of table line 174. ******* ******************************************************************************* [FN1]Oral polio vaccine (OPV) or inactivated polio vaccine (IPV) or any combination of these vaccines is acceptable. [FN2] Applies only to children entering at kindergarten level (or at first grade level if kindergarten skipped) or below on or after August 1, 1997. [FN3] Required only for children who have not reached the age of 4 years 6 months. [FN4] Applies only to children (of any age) entering or advancing to the seventh grade on or after July 1, 1999. [FN5] Children admitted to California schools at the Kindergarten level or above before July 1, 2001 are exempt from this requirement. 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70....+.... Note: Authority cited: Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code. s 6025. Unconditional Admission. Any pupil age 18 months or older who has received all the immunizations against poliomyelitis, diphtheria, tetanus, pertussis, measles (rubeola), rubella, Haemophilus influenzae type B, mumps, hepatitis B and varicella (chickenpox) required for his or her age, as defined in Table 1, Section 6020, or who has documented a permanent medical exemption or a personal beliefs exemption to immunization in accordance with Section 6051, shall be admitted unconditionally as a pupil to a given public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center. However, for some pupils admitted unconditionally to a child care center, day nursery, nursery school, family day care home, or development center, an additional dose of DTP and/or polio vaccine will be required for admission to school at kindergarten level and above, as indicated in Table 1, Section 6020. Note: Authority cited: Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code. s 6030. Conditional Admission to Prekindergarten Level. Note: Authority cited: Sections 208 and 3390, Health and Safety Code. Reference: Section 3381, Health and Safety Code. s 6035. Conditional Admission. (a) Any pupil seeking admission to a given public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center who lacks documentation of having received all the required vaccine doses against poliomyelitis, diphtheria, tetanus, pertussis, measles, rubella, Haemophilus influenzae type B, mumps, hepatitis B and varicella (chickenpox) as specified in Table 1, Section 6020, and has not obtained a permanent medical exemption or a personal beliefs exemption to immunization in accordance with Section 6051, may be admitted conditionally if: (1) he or she has not received all the immunizations required for his or her age group but has commenced receiving doses of all the vaccines in accordance with Table 2, is not currently due for any doses at the time of admission (if he or she is due for any doses at this time they must be obtained before admission), and the pupil's parent or guardian is notified of the date by which the pupil must complete all the required immunizations in accordance with Table 2; or (2) he or she is under age 18 months and has received all the immunizations required for his or her age group but will require additional vaccine doses at an older age, and the pupil's parent or guardian is notified of the date by which the pupil must complete all the remaining doses when they become due in accordance with Table 1, Section 6020; or (3) he or she has obtained a temporary medical exemption from immunization in accordance with Section 6050, and the pupil's parent or guardian is notified of the date by which the pupil must complete all the required immunizations when the temporary exemption terminates; or (4) he or she is a pupil entering a child care center governed by Education Code Section 8263(c), where a different deadline for obtaining all required immunizations may apply. (b) The public or private elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center shall not allow the admission of any pupil seeking entry who does not meet the requirements for admission under Section 6025 or 6035. The principal or administrator shall advise the pupil, or the parent or guardian, to contact a physician or agency that provides immunizations. Table 2: Conditional Admission Immunization Schedule _______________________________________________________________________________ Vaccine Dose Time Intervals _______________________________________________________________________________ Polio [FN1] 1st dose...... Before admission 2nd dose...... As early as 6 weeks but no later than 10 weeks after the 1st dose. Before admission if 10 or more weeks have elapsed since the 1st dose at the time of admission. 3rd dose...... As early as 6 weeks but no later than 12 months after the 2nd dose. Before admission if 12 or more months have elapsed since the 2nd dose at the time of admission. 4th dose (Required only for entry to kindergarten level or above)..... Age 4-6 years: If the 3rd dose was given before the 4th birthday one more dose is required before admission. Age 7-17 years: If the 3rd dose was given before the 2nd birthday, one more dose is required before admission. _______________________________________________________________________________ Diphtheria, Tetanus, and 1st dose...... Before admission. Pertussis 2nd dose...... As early as 4 weeks but no later than 8 weeks after the FOR PUPILS UNDER AGE 7 YEARS: 1st dose. Before admission if 8 or more weeks have elapsed since the 1st dose at the time of admission. 3rd dose...... As early as 4 weeks but no later than 8 weeks after the Diphtheria-tetanus-pertussis 2nd dose. Before admission if 8 (DTP) or combination or more weeks have of DTP and diphtheria-tetanus elapsed since the 2nd dose at toxoids the time of admission. 4th dose...... As early as 6 months but no later than 12 monthsafter the 3rd dose. Before admission if 12 or more months have elapsed since the 3rd dose at the time of admission. 5th dose (Required only for pupils ages 4-6 years for entry to kindergarten level and If the 4th dose was given above)...... before the 4th birthday, one OR more dose is required before admission. FOR PUPILS AGE 7 YEARS AND 1st dose...... Before admission. OLDER: 2nd dose...................... As early as 4 weeks but no later than 8 weeks after the 1st dose. Before admission if 8 or more weeks have Diphtheria-tetanus elapsed since the 1st dose at the time of admission. (Pertussis not required) 3rd dose...... As early as 6 months but no later than 12 months after the 2nd dose. Before admission if 12 or more months have elapsed since the 2nd dose at the time of admission. 4th dose...... If the 3rd dose was given before the 2nd birthday, one more dose is required before admission. B@@ -------------- ------------------------------- -- --------------- Recommended Before entry, 1 Td dose is but not recommended if 5 years or required more for 7th grade have elapsed since the last entry [FN2]: dose of DTP, DT, Td or Booster Tetanus. dose of Td. _______________________________________________________________________________ Measles One dose Before admission. If the pupil only........ is under age 15 months, this dose is required when age 15 months is reached. Note: For children entering 1st dose...... Before admission. kindergarten (or first grade if kindergarten is skipped) on 2nd dose...... As early as 1 month but no or after August 1, 1997, later than 3 months after two doses are required. For the 1st dose. children entering 7th grade on or after July 1, 1999, the series shall be in process or completed. _______________________________________________________________________________ Rubella One dose Before admission. If the pupil only........ is under age 15 months, this dose is required when age 15 months is reached. _______________________________________________________________________________ Mumps (Not required for pupils One dose Before admission. If the pupil age 7 years and older) only........ is under age 15 months, this dose is required when age 15 months is reached. _______________________________________________________________________________ Hib Children 2-14 months old Two doses..... 1st dose before admission. 2nd dose as early as 2 months but no later than 3 months after the 1st dose. Children 15 months-4 1/2 years One dose...... Before admission. old _______________________________________________________________________________ Hepatitis B -For children 1st dose...... Before admission. entering at kindergarten level (or first 2nd dose...... As early as 1 month but no grade if kindergarten later than 2 months after the skipped) first or below on or after August 1, dose. 1997. For children entering 7th grade on or after July 1, 3rd dose...... Infants and children under age 1999, the series shall be in 18 months: As early as 2 process or completed. months but no later than 12 months after the 2nd dose. Also, no earlier than 4 months after the 1st dose. Children age 18 months and older: As early as 2 months but no later than 6 months after the 2nd dose. Also, no earlier than 4 months after the 1st dose. _______________________________________________________________________________ Varicella [FN3] - For children 1st dose...... Before admission aged 13 through 17 years not admitted to California 2nd dose...... As early as 4 weeks but no schools before July 1, 2001. longer than 3 months after first dose _______________________________________________________________________________ [FN1] Oral polio vaccine (OPV) or inactivated polio vaccine (IPV) or any combination of these vaccines is acceptable. [FN2] Applies only to children (of any age) entering or advancing to the 7th grade on or after July 1, 1999. [FN3] Children admitted to California schools at the Kindergarten level or above before July 1, 2001 are exempt from this requirement. Note: Authority cited: Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code. s 6040. Requirements for Continued Attendance. An already admitted pupil who is subsequently discovered not to have received all the immunizations which were required before admission or who is subsequently discovered not to have complied with the requirements for conditional admission specified in Section 6035 shall continue in attendance only if he or she receives all vaccine doses for which he or she is currently due and provides documentation of having received such doses no later than 10 school days after he or she or the parent or guardian is notified. The school, child care center, day nursery, nursery school, family day care home, or development center shall notify the pupil or the parent or guardian of the time period (no longer than 10 school days) within which the doses must be received. Note: Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335), 120340 and 120375 (a) and (b), Health and Safety Code. s 6045. Special Immunization Schedules. (a) Immunization schedules not conforming to those specified in Sections 6020 and 6035 may be approved by the State Department of Health Services when substantial medical or other conditions warrant, such as during an outbreak or epidemic of a particular disease. Note: Authority cited: Sections 208 and 3390, Health and Safety Code. Reference: Section 3381, Health and Safety Code. s 6050. Conditional Admission with Temporary Medical Exemption. A pupil who is temporarily exempt from immunization for medical reasons shall be admitted on condition that required immunizations are obtained at the termination of the exemption; the fact of the temporary medical exemption shall be recorded on the California School Immunization Record, PM 286 (1/02) as provided in Section 6070. A pupil with a temporary medical exemption may be subject to exclusion pursuant to Section 6060. Note: Authority cited: Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120365, 120370 and 102375, Health and Safety Code. s 6051. Unconditional Admission with Permanent Medical Exemption or Personal Beliefs Exemption. A pupil with a permanent medical exemption or a personal beliefs exemption to immunization shall be admitted unconditionally. A permanent medical exemption shall be granted upon the filing with the governing authority of a written statement from a licensed physician to the effect that the physical condition of the pupil or medical circumstances relating to the pupil are such that immunization is permanently not indicated. The fact of the permanent medical exemption shall be recorded on the California School Immunization Record, PM 286 (1/02) as provided in Section 6070. A permanent medical exemption may be provided for one or more vaccines. A physician may provide a written statement that the pupil is medically exempt from the measles (rubeola) and/or varicella (chickenpox) requirements as a result of having had measles (rubeola) and/or varicella (chickenpox) disease, respectively. A physician may provide a written statement that the pupil is medically exempt from the rubella and/or mumps requirement as a result of having had laboratory confirmed illness with the corresponding disease. A personal beliefs exemption shall be granted upon the filing with the governing authority of a letter or affidavit from the pupil's parent or guardian or adult who has assumed responsibility for his or her care and custody in the case of a minor, or the person seeking admission if an emancipated minor, that such immunization is contrary to his or her beliefs. The fact of the personal beliefs exemption shall be recorded on the California School Immunization Record, PM 286 (1/02). A pupil with an exemption which is not based on pre-existing immunity to disease may be subject to exclusion pursuant to Section 6060. Note: Authority cited: Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120365, 120370 and 120375, Health and Safety Code. s 6055. Conditions for Admission Not Fulfilled. The governing authority of the school, child care center, day nursery, nursery school, family day care home, or development center shall exclude from further attendance any pupil who fails to obtain the required immunizations within no more than 10 school days following receipt of the notice provided pursuant to Section 6040, unless the pupil is exempt for medical reasons or personal beliefs, until the pupil provides written evidence that he or she has received another dose of each required vaccine due at that time. Any pupil so excluded shall be reported to the attendance supervisor or to the building administrator. Note: Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335), 120340, 120365, 120370 and 120375, Health and Safety Code. s 6060. Pupil Not Completely Immunized and Exposed to Communicable Disease. Whenever the governing authority has good cause to believe that a pupil who is not completely immunized against a particular communicable disease may have been exposed to that disease, that information shall be reported by the governing authority immediately by telephone to the local health officer. The local health officer shall determine whether the pupil is at risk of developing the disease and, if so, may require the exclusion of the pupil from that school, child care center, day nursery, nursery school, family day care home, or development center until the completion of the incubation period and the period of communicability of the disease. Note: Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health and Safety Code. Reference: Sections 3381 (120335) and 120375(c), Health and Safety Code. s 6065. Documentary Proof. (a) There shall be a written record given to the person immunized or to his or her parent or guardian, by the physician or agency performing the immunization which shall contain the following information: (1) Name of the person. (2) Birthdate. (3) Type of vaccine administered. (4) Month, day, and year of each immunization. (5) Name of the physician or agency administering the vaccine. (b) The written record shall be shown by the parent, guardian or person immunized to the governing authority of the school, child care center, day nursery, nursery school, family day care home, or development center at the time of the pupil's admission and at subsequent times when required by the governing authority to determine the pupil's immunization status. For the pupil to be admitted, the written record shall show at least the month and year of each required vaccine dose. For doses of measles, rubella and mumps vaccine given during the month of the first birthday the record shall also show the specific date (i.e., month, day and year) of immunization. (c) When such written records are not available, the pupil shall not be admitted and the parent or guardian shall be referred to a physician or nurse for review of his or her immunization history and provision of immunizations as needed. (d) Pupils who were admitted to a California school at kindergarten level or above before March 5, 1986 on the basis of a parent or guardian's having completed and signed a California School Immunization Record PM 286 (1/02) as provided by Section 6070 that shows at least the month and year each required vaccine dose was received (and also shows the day of immunization if a measles, rubella, and/or mumps vaccine dose was received during the month of the first birthday), rather than on the basis of a parent or guardian's having provided a written record, as described in Parts (a) and (b) of this Section, shall be allowed to continue in attendance in California schools. Note: Authority cited: Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code. s 6070. School/Child Care Facility Immunization Record. (a) The governing authority of each school, child care center, day nursery, nursery school, family day care home, or development center shall record each pupil's immunizations on the California School Immunization Record, PM 286 (1/02) and is in its entirety, incorporated by reference which, at kindergarten level and above, shall be part of the mandatory permanent pupil record as defined in Section 430 of Title 5, California Code of Regulations. (b) Each pupil's immunization record shall contain: (1) Name of pupil. (2) Birthdate (month, day and year). (3) Date of unconditional or conditional admission (month, day, and year). (4) Type of vaccine and date (month, day, and year) each dose was administered. Although month, day and year of vaccine administration should be recorded, a California Immunization Record, PM 286, showing only month and year of vaccine dose(s) shall be allowed, except that for records showing measles, rubella, and/or mumps vaccine doses given during the month of the first birthday, the date of immunization shall also be recorded. (5) Date and type of exemption, if any. (c) The immunization record shall be transferred with the mandatory permanent pupil record. (d) For pupils at kindergarten level and above transferring between school campuses within California or from a school in another state to a school in California, if the mandatory permanent pupil record or other immunization record has not been received at the time of entry to the new school, the governing authority of the school may admit the pupil for a period of up to 30 school days. If the mandatory permanent record or other immunization record has not arrived by the end of this period, the governing authority shall require the parent or guardian to present a written immunization record, as described in Section 6065, documenting that all currently due required immunizations have been received. If such a record is not presented, the pupil shall be excluded from further attendance until he or she comes into compliance with the immunization requirements, as outlined in Sections 6020, 6035, and 6065. (e) The governing authority shall see that the immunization record of each pupil admitted conditionally is reviewed every 30 days until that pupil has received all the required immunizations. Any immunizations received subsequent to conditional admission shall be entered in the pupil's immunization record. Note: Authority cited: Sections Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code. s 6075. Reporting. (a) The governing authority of each school, child care center, day nursery, nursery school, family day care home, or development center shall file a report with the state and local health departments on the immunization status of new entrants annually or when needed to determine immunization status such as during an epidemic or potential epidemic. The forms to be used for these reports are: (1) Schools with kindergartens: IMMUNIZATION ASSESSMENT OF KINDERGARTEN STUDENTS -ANNUAL REPORT [PM 236 (3/01)] and this form in its entirety is incorporated by reference. (2) Schools with seventh grades: IMMUNIZATION ASSESSMENT OF SEVENTH GRADE STUDENTS [DHS 8259 (8/98)]. This form is hereby incorporated by reference. (3) Child care centers, day nurseries, nursery schools and development centers: ANNUAL IMMUNIZATION REPORT ON CHILDREN ENROLLED IN CHILD CARE CENTERS [DHS 8018 (3/01)] and this form is in its entirety incorporated by reference or ANNUAL IMMUNIZATION ASSESSMENT REPORT OF CHILDREN ENROLLED IN CHILD CARE CENTERS -LINE LISTING [DHS 8387 (3/94)]. The Department of Health Services or the local health department will provide the appropriate reporting form. (4) Family day care homes: ANNUAL FAMILY DAY CARE HOME IMMUNIZATION SURVEY [DHS 8529 (10/00)] and this form is in its entirety incorporated by reference. (b) The annual report shall contain at least the following information on new entrants in kindergarten or lower level classes only: (1) Enrollment as of date of report. (2) Number of new entrants admitted unconditionally specifying the number who have received all immunizations, the number who are medically exempt and the number who are exempt for personal beliefs. (3) Number of new entrants admitted conditionally specifying the number of doses received of poliomyelitis, diphtheria, tetanus, pertussis, measles, rubella, Haemophilus influenza type b (Hib), mumps, hepatitis B, and varicella (chickenpox) vaccines. (4) Other information requested by the State Department of Health Services. (c) Additional reports which include new entrants in all grades may be requested during an epidemic or potential epidemic. Note: Authority cited: Sections 100275, 120330 and 120335, Health and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safety Code. s 6500. Definitions. (a) Preventable Heritable or Congenital Disorders. "Preventable heritable or congenital disorders" means any disorder or abnormality present at birth which is detectable by testing a newborn and for which effective means of prevention or amelioration exist. (b) Newborn. "Newborn" means an infant 30 days of age and under. (c) Birth Attendant. "Birth attendant" means any person licensed or certified by the State to provide maternity care and to deliver pregnant women or to practice medicine. (d) Perinatal Licensed Health Facility. "Perinatal licensed health facility" means any health facility licensed by the State and approved to provide perinatal, delivery, newborn intensive care, newborn nursery or pediatric services. (e) Days of Age. "Days of age" means the measurement of the age of a newborn in 24-hour periods so that a newborn is one day of age 24 hours following the hour of birth. (f) Discharge. "Discharge" means release of the newborn from care and custody of the perinatal licensed health facility to the parents or into the community. (g) Transfer. "Transfer" means release of the newborn from care and custody of one perinatal licensed health facility to care and custody of another perinatal licensed health facility, or admission to another perinatal licensed health facility of a newborn in an out-of-state facility. (h) Newborn's Physician. "Newborn's physician" means the physician responsible for the care of the newborn after discharge from the hospital. (i) Initial Specimen. "Initial specimen" means the first specimen collected subsequent to birth, pursuant to these regulations. (j) Initial Test. "Initial test" means the first valid newborn screening test or combination of tests of a newborn for each disorder covered by these regulations. (k) Initial Presumptive Positive Test. "Initial presumptive positive test" means a newborn's blood specimen which is defined as positive for reporting purposes. ( l) Inadequate Specimen. "Inadequate specimen" means a newborn's blood specimen which is not suitable in quality or quantity to perform newborn screening for one or more of the disorders covered by these regulations. (m) Repeat Specimen. "Repeat specimen" means a specimen collected from a newborn following the newborn screening laboratory's report that a previously collected specimen was either inadequate or that test results were inconclusive. (n) Repeat Test. "Repeat test" means a test required by these regulations to be repeated for a newborn because the previous specimen or test results were inadequate or test results were not complete. (o) Recall Specimen. "Recall specimen" means a specimen collected from a newborn because the initial test or combination of tests was presumptive positive for any of the disorders covered by these regulations. (p) Recall Test. "Recall test" means a test ordered collected from a newborn because the initial test or combination of tests was presumptive positive for any of the disorders covered by these regulations. (q) Newborn Screening Laboratory. "Newborn screening laboratory" means a laboratory operated by the Department or a laboratory contracting with the Department to conduct tests required by this article. (r) Area Genetic Center. "Area genetic center" means an institution, corporation, hospital or university medical center having specialized expertise designated by the Department to serve a specific geographic area of the State which has contracted with the Department to provide follow-up, referral and diagnosis of a preventable heritable or congenital disorder as defined in this Article. (s) Sickle Cell Education and Counseling Program. "Sickle cell education and counseling program" means an educational and counseling program in which the disease orientation is, in whole or in major part, sickle cell disease. (t) Sickle Cell Counselor. "Sickle cell counselor" means a person who provides face to face information on the medical, social, and genetic consequences of sickle cell disease and trait and who has successfully completed an approved sickle cell counselor training program and is certified as such by the Department of Health Services. Physicians and individuals with a master's degree in genetic counseling who are board eligible or board certified by the American Board of Medical Genetics are not required to complete such a training program. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 309, 325, 326 and 327, Health and Safety Code. s 6500.1. Effective Date of Repeal and Implementation. Note: Authority cited: Section 208, Health and Safety Code: Reference: Sections 151 and 309, Health and Safety Code. s 6500.5. Definitions. s 6501. Scope of Newborn Testing. (a) Each newborn born in California shall be tested for hereditary hemoglobinopathies, phenylketonuria, hypothyroidism and galactosemia in accordance with procedures in this Article. (b) The provisions of Section 6501 (a) shall not apply if a parent or legally appointed guardian objects to a test on the ground that it conflicts with his or her religious beliefs or practices. If the parent or legal guardian refuses to allow the collection of a blood specimen, such refusal shall be made in writing and signed by a parent or legally appointed guardian and included in the newborn's medical or hospital record. (c) The provisions of Section 6501(a) shall not apply if the newborn has a condition almost certainly to be fatal in the first thirty (30) days of life which shall be documented in the medical record. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 151, 154, 155, 309, 325, 326 and 327, Health and Safety Code. s 6502. Laboratory Tests. Note: Authority cited: Sections 151 and 208, Health and Safety Code. Reference: Section 309, Health and Safety Code. s 6502.1. Confidentiality. (a) All information, records of interview, written reports, statements, notes, memoranda, or other data procured by an individual, group or research team in the course of any testing under this article shall be confidential and shall be used solely for the purposes of medical intervention, counseling, or specific research project approved by the Department. (b) Except as provided by law, such information shall not be exhibited nor disclosed in any way, in whole or in part, by any individual, group, or research team except with the written consent of the person or his/her legally authorized representative unless such data can be made available in a manner which preserves anonymity of the persons tested. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 151 and 309, Health and Safety Code. s 6503. Newborn Screening Laboratories. (a) The Department shall designate laboratories and tests to be used for Department required newborn tests. Such laboratories shall be either laboratories operated by the Department for quality control confirmatory and emergency testing or contractor laboratories licensed as clinical laboratories under the Business and Professions Code. (b) Perinatal licensed health facilities and birth attendants shall submit required specimens to the newborn screening laboratory designated by the Department. (c) Contract newborn screening laboratories shall be limited to laboratories that shall have submitted a bid acceptable to the Department on a competitive contract to provide laboratory services in sufficient volume to cover all of the newborns born in a geographical area, as defined by the Department, plus an appropriate emergency capacity. The Department will define not more than six areas and may combine areas if necessary to reduce costs or assure statewide coverage. (d) Notwithstanding (c) above a comprehensive prepaid group practice direct health care service plan with 20,000 or more births in the last completed calendar year for which complete statistics are available may have a laboratory serving a comprehensive prepaid group practice health care service plan designated a newborn screening laboratory under terms of a written agreement as defined in Section 6508(b) or may provide services in conformity with the terms of a mutually acceptable contract for services. (e) Newborn screening laboratories shall participate in a proficiency testing program conducted by the Department's laboratory and shall maintain levels of performance acceptable to the Department. (f) Newborn screening laboratories contracting with the Department shall be subject to on-site inspections and review of laboratory performance of tests and laboratory records. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 151 and 309, Health and Safety Code. s 6504. Use of Newborn Screening Forms. (a) All birth attendants engaged in providing perinatal care shall provide pregnant women, prior to the estimated date of delivery, with a copy of the informational material, titled "Important Information for Parents," provided by the Department. (b) Perinatal licensed health facilities shall provide each pregnant woman admitted for delivery with a copy of the informational material provided by the Department, titled "Important Information for Parents," prior to collection of the blood specimen if such information has not been provided pursuant to subsection (a) above. If a woman is unable to read such material, it shall be translated or read to her in a language she understands. (c) Department approved specimen collection forms shall not be copied, printed, reproduced, acquired, purchased or distributed other than as provided for in these regulations. (d) Such Department approved specimen collection forms shall be fully and accurately completed by birth attendants, perinatal licensed health facilities and laboratories and a copy shall be filed in each newborn's medical record. (e) Perinatal licensed health facilities shall maintain such records as are necessary to assure compliance with these regulations and provide the Department with such data as may be periodically required including, but not limited to, information on all newborns discharged or transferred from the facility without collection of a blood specimen. All such information and records shall be confidential but shall be open to examination by the Department personnel or its designated agents for any purpose directly connected with the administration of the newborn screening program. (f) Birth attendants or physicians shall provide to parent(s) or legally appointed guardian(s) who object to the tests on the basis it is in conflict with their religious beliefs or practices, a refusal form approved by the Department and shall obtain the appropriate signature(s) upon the form. If the parent(s) or legally appointed guardian(s) is unable to read such material, it shall be translated or read to such person(s) in a language understood by such persons. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 151 and 309, Health and Safety Code. s 6505. Collection of Specimens. (a) Birth attendants, laboratories and hospitals shall collect specimens using the technique for blood collection distributed by the Department. (b) Physicians or birth attendants who are caring for newborns born in perinatal licensed health facilities shall have blood specimens collected using Department-approved specimen collection forms in accordance with criteria distributed by the Department including the following: (1) A specimen must be collected from any untested infant prior to blood transfusion. (2) For newborns discharged before six days of age, a blood specimen shall be obtained as close to the time of discharge from the perinatal licensed health facility as is practical regardless of age or feeding history, unless the newborn is transferred for continuing care to another perinatal licensed health facility on or before the sixth day of age. Perinatal licensed health facilities which discharge infants before 24 hours of age may request a waiver from this requirement documenting how such newborns will be tested on or before 6 days of age. Such alternative testing schedules must be approved in writing by the Department. (3) For newborns remaining in perinatal licensed health facilities beyond five days of age, a blood specimen shall be obtained from the newborn on the sixth day of age regardless of feeding history. (4) For newborns received by transfer on or before six days of age, the receiving hospital shall obtain a blood specimen as close to discharge as possible, and if not discharged by the sixth day, a blood specimen shall be obtained on the sixth day of life. (c) For newborns not born in a perinatal licensed health facility but admitted to a perinatal licensed health facility within the first six days of age, a specimen shall be obtained as close to discharge as possible, and if not discharged by the sixth day of life, a blood specimen shall be obtained on the sixth day of life unless the newborn's physician has evidence that the specimen was previously obtained and records the results of the test in the newborn's medical record. (d) For newborns not born in a perinatal licensed health facility but admitted to a perinatal licensed health facility after six days of age but within the first 30 days of age, a blood specimen shall be obtained within 48 hours after admission unless the newborn's physician has evidence that the specimen was previously obtained and records the results of the test in the newborn's medical record. (e) Physicians attending sick newborns who exhibit symptoms suggestive of galactosemia, hypothyroidism or phenylketonuria (PKU), in addition to immediate diagnostic tests from local laboratory sources, shall have a blood specimen collected from the newborn and submitted to a newborn screening laboratory using forms purchased from the Department. (f) Physicians attending critically ill newborns who require special care may postpone collection of a blood specimen until the newborn's emergency life threatening condition is stabilized. (g) Birth attendants or physicians attending newborns not born in a perinatal licensed health facility and not subsequently admitted to a licensed health facility during the first six days of age, shall have a blood specimen collected from the newborn between the second and sixth days of age and submitted to a newborn screening laboratory using forms obtained from the Department. (h) If a newborn is born outside of a perinatal licensed health facility and the birth is not attended by a birth attendant and the newborn is not subsequently admitted to a perinatal licensed health facility within the first ten days of age, the person required to register the birth shall arrange for a blood specimen to be collected and submitted to a newborn screening laboratory between the second and tenth day of age. (i) Initial specimens shall be collected using a Department-approved form and shall be placed in the United States mail or other approved channel of transmittal to the assigned Department-approved laboratory as soon as possible, but not later than 12 hours after they are obtained. (j) The blood specimen and information obtained during the testing process becomes the property of the State and may be used for program evaluation or research by the Department or Department-approved scientific researchers without identifying the person or persons from whom these results were obtained, unless the person or his/her legally authorized representative specifically prohibits such use in writing. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 151 and 309, Health and Safety Code. s 6506. Reporting and Follow-Up of Tests. (a) Perinatal licensed health facilities shall review each newborn's medical record within 14 days from the date of discharge to determine that the results of required tests are filed in the newborn's medical record, or that a parent's or legal guardian's signed refusal has been filed in the newborn's medical record. (b) Whenever a perinatal licensed health facility determines that a discharged newborn has not received the mandated tests, the facility shall contact the newborn's physician by telephone to inform him/her that a specimen must be obtained and immediately send written notification to the newborn's physician and the Department. If the newborn's physician cannot be contacted or will not obtain a specimen, the perinatal licensed health facility shall notify the Department-approved area genetic center by telephone and shall send written notification within five days to the area genetic center and the Department. (c) Whenever a perinatal licensed health facility determines that a specimen has been obtained, but there are no results available in the newborn's medical record the facility shall send written notification within five days to the Department. (d) When the newborn's physician is notified by telephone by the perinatal licensed health facility that a newborn was discharged from the perinatal licensed health facility before a specimen was taken, the newborn's physician shall make every reasonable effort to have a specimen obtained within five days of notification. If the newborn's physician cannot obtain the specimen, the area genetic center shall be notified by the newborn's physician by telephone. Such telephone notification shall be noted in the newborn's physician's records, specifying the date of notification, the person notified and the information provided. (e) When a newborn's physician is notified by the laboratory by telephone that a specimen is inadequate, the physician so notified shall make every reasonable effort to have an adequate specimen obtained within five days of notification. If the newborn's physician so notified, cannot obtain the repeat specimen, the physician shall notify the area genetic center as soon as possible by telephone. Such telephone notification shall be noted in the newborn's physician's records specifying the date of notification, the person notified and the information provided. (f) When the newborn's physician is notified by telephone by the Department-approved area genetic center of an initial presumptive positive test result the newborn's physician shall obtain an adequate recall blood specimen from the newborn and submit it to the designated laboratory within 48 hours. If the recall blood specimen cannot be obtained within 48 hours, the newborn's physician shall notify the area genetic center by telephone. Such telephone notification shall be noted in the newborn's physician's records, specifying the date of notification, the person notified and the information provided. (g) Repeat and recall specimens required by these regulations shall be collected on Department approved forms, placed in appropriate containers, and shall be placed in the United States mail or other approved channel of transmittal to the assigned, Department-approved laboratory as soon as possible, but not later than 12 hours after they have been obtained. (h) All physicians making an initial diagnosis of a preventable heritable disorder for which testing is required under this Article shall report such diagnosis and the information necessary for follow-up and investigation to the Department. (i) Willful or repeated failure to comply with these regulations shall be referred by any person having knowledge of non-compliance to the appropriate licensing authority. Failure to report may constitute grounds for disciplinary action including revocation of license. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 151 and 309, Health and Safety Code. s 6507. Local Agencies Responsibilities. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 151 and 309, Health and Safety Code. s 6507.1. Local Agencies Responsibilities. (a) the county registrar shall provide a copy of the informational material prepared and provided by the Department to each person registering the birth of a newborn that occurred outside of a perinatal licensed health facility when the said newborn was not admitted to a perinatal licensed health facility within the first 30 days of age. The local health officer and the Department shall be notified of each such registration by the county registrar. (b) Each local health department in the county where a newborn resides shall be responsible for making every reasonable effort to obtain specimens when requested by the Department-approved area genetic center or the Department. If after every reasonable effort a specimen cannot be obtained, the local health department may, after 30 days, with approval from the Department, terminate efforts. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 151 and 309, Health and Safety Code. s 6507.2. Sickle Cell Education and Counseling Programs. (a) Each sickle cell education and counseling program shall apply for and obtain written approval from the Department of Health Services. Such approval shall be contingent upon compliance with all sections of these regulations. (b) Each sickle cell education and counseling program shall: (1) Provide counseling services to the clients. (2) Employ State-approved sickle cell counselors to perform all of the counseling following, or relating to, any abnormal hemoglobinopathy finding. (3) Demonstrate, upon request by the Department of Health Services, that each of its counselors successfully participates in State-approved educational programs which serve to update the knowledge and enhance the proficiency of such counselors. (4) Have a physician with special training and experience in pediatric hematology to serve as medical director or consultant to order and interpret laboratory tests used in counseling. (5) Have written protocols to protect the confidentiality and security of all records containing personal information. (6) Use only State-approved educational materials. (7) Use any laboratory that meets the Department's standards for sickle cell hemoglobin testing. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 325, 326 and 327, Health and Safety Code. s 6507.3. Certificate of Approval As a Sickle Cell Counselor. (a) A sickle cell counselor shall obtain a certificate of approval from the Department of Health Services upon presentation of written evidence that he or she has: (1) Completed a course at a sickle cell counselor training center approved by the Department with such center's endorsement of his or her ability to function as a sickle cell counselor, and/or (2) Successfully completed an examination or examinations which demonstrate his or her knowledge or expertise in the field, and one or more personal interviews to demonstrate an understanding of, and ability to communicate with persons who have sickle cell disease or sickle cell trait. (b) All sickle cell counselors must provide documentation of completion of State-approved training to update skills and knowledge on an annual basis. (c) This section shall not apply to physicians. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 325, 326 and 327, Health and Safety Code. s 6507.4. Voluntary Participation. Participation by any person in a sickle cell education and counseling program in which medical information is obtained through interview, test or other ascertainment procedure shall be wholly voluntary and shall not be a prerequisite to eligibility for, or receipt of, any other services or assistance from, or to participation in any other program. Note: Authority cited: Section 309, Health and Safety Code. Reference: Section 151, Health and Safety Code. s 6507.5. Informed Consent. (a) A sickle cell education and counseling program shall obtain informed consent from each adult upon whom testing or any other screening procedure is to be performed. If the person is a minor other than a newborn, informed consent shall be obtained from such child's parent or guardian. An informed consent shall be obtained from an emancipated minor without the need for parent or guardian consent. (b) The informed consent shall be in writing in format approved by the Department and shall be signed by the person, by his or her guardian or, except in the case of an emancipated minor, by his or her parent. Note: Authority cited: Section 309, Health and Safety Code. Reference: Section 151, Health and Safety Code. s 6507.6. Approval of Hemoglobin Counseling Laboratories. (a) All laboratories that accept specimens from an approved sickle cell counseling program shall be in compliance with the Business and Professions Code governing licensed clinical laboratory operations and personnel (commencing with Section 1200 of the Business and Professions Code) or be an approved public health laboratory operated in accordance with the California Health and Safety Code, Section 1000 et seq. (b) All laboratories involved in sickle cell screening as defined in these regulations shall use a test or combination of tests with demonstrated ability to distinguish hemoglobins including F, A, S, C, D, and E, as well as the thalassemias. (c) The State Department of Health Services shall have the responsibility of monitoring sickle cell screening laboratories coming under the scope of these regulations. Such monitoring may be accomplished by on-site inspections and proficiency testing, or any other effective method. The Department may deny, revoke, or suspend the approval of any laboratory which does not comply or continue to comply with the above qualifications. Note: Authority cited: Sections 208(a), 309 and 325, Health and Safety Code. Reference: Sections 325 and 327, Health and Safety Code. s 6507.7. Sickle Cell Trait Follow-Up Vendor. (a) A sickle cell trait follow-up vendor shall mean any sickle cell education and counseling program that is: (1) approved under this subchapter, and (2) signs a vendor agreement to provide services in accordance with Department policies, including a fee schedule provided by the Department. The Department may obtain and provide reimbursements for any or all follow-up services authorized as a result of newborn sickle cell screening from such approved vendors. Note: Authority cited: Section 309, Health and Safety Code. Reference: Sections 325 and 326, Health and Safety Code. s 6508. Fee Collection. (a) Perinatal licensed health facilities and birth attendants shall obtain from the Department a sufficient supply of specimen collection forms to permit collection of a blood specimen from each newborn required to be tested under these regulations. (b) The Department shall collect a fee for each specimen record form provided and a program participation fee for all services provided. The fee for a specimen record form shall be one (1) dollar and for program services shall be seventy-seven (77) dollars except for a comprehensive prepaid group practice direct health care service plan with 20,000 or more births in the last completed calendar year for which complete statistics are available, which elects to provide testing, follow-up and/or counseling services to its members. The fee for such plans shall be equal to the Department's cost of administration of the newborn screening program, to be determined by reducing the seventy-seven (77) dollar program service fee by the annual statewide average per infant contracted cost of laboratory testing, follow-up and/or counseling services rendered during the previous fiscal year. In order to qualify for this special fee a medical group serving a comprehensive prepaid group practice direct care service plan with 20,000 or more births shall sign a written agreement which contains the same standards and conditions, except as to payment or where specifically waived, as are applicable to the newborn screening laboratories and area genetic centers, adhere to the regulations governing the program, and to submit to monitoring and evaluation of compliance. Failure to comply with these conditions after being given written notification and thirty (30) days to correct deviations shall result in loss of the option. In the event the option is lost the State shall designate appropriate contractors to provide services. The provisions of this section shall apply even if the newborn is part of a State-approved demonstration project. (c) Birth attendants and physicians attending newborns who are under six days of age and who were not born in perinatal licensed health facilities and not subsequently admitted to perinatal licensed health facilities shall obtain a sufficient supply of specimen record forms to permit collection or shall arrange for a collection of a blood specimen from each such newborn attended. (d) Birth attendants and physicians attending newborns and perinatal licensed health facilities shall not charge parents or third parties responsible for medical care coverage fees for participation in the newborn screening program in addition to those specified in this section, except for reasonable fees for costs of blood specimen collection and handling which shall not exceed six (6) dollars. (e) The perinatal licensed health facility shall make available to the responsible physician, at no additional charge, specimen collection services or a specimen record form for obtaining either a repeat specimen for an inadequate specimen or a specimen on a newborn discharged without the test having been obtained. (f) Birth attendants and physicians submitting a blood specimen for newborn screening on a form other than those approved by the Department shall be charged a handling fee of five (5) dollars in addition to the usual fee for program services and specimen record form specified in (b) above for each such specimen. Note: Authority cited: Sections 124977, 124996 and 125000, Health and Safety Code. Reference: Sections 124977, 124996, 125000 and 125001, Health and Safety Code. s 6510. Rhesus (Rh) Hemolytic Disease of the Newborn. (a) Medical staffs of hospitals and physicians thereof shall in providing for the care of pregnant women determine that a blood specimen has been obtained for the determination of rhesus (Rh) blood type or shall obtain or cause to be obtained a blood specimen within 24 hours of termination of pregnancy whether by delivery or by spontaneous or therapeutic abortion for this purpose as required by Article 2.7, Chapter 2, Part 1 of Division 1 of the Health and Safety Code. (b) All cases, or suspected cases of rhesus (Rh) hemolytic disease of the newborn, shall be reported to the Department of Health Services. Every patient diagnosed in any licensed hospital as having such condition shall be reported by the hospital on the form provided by the Department for this purpose. The hospital shall notify the physician making the diagnosis that such a report has been filed. Note: Authority cited: Sections 151, 208 and 306(b), Health and Safety Code. Reference: Sections 304, 305 and 306, Health and Safety Code. s 6521. Definitions. (a) Neural Tube Defects of the Fetus. "Neural tube defects of the fetus" means any malformation of the fetus caused by failure of the developing spine and skull to properly close. Examples are spina bifida and anencephaly. (b) Birth Defects. "Birth defects" means any functional or structural defect caused by failure or error in the development of a fetus that is capable of being prenatally detected and for which the Department has provided a surveillance or screening program including but not limited to neural tube defects, ventral wall defects, and chromosomal defects. (c) Expanded AFP Prenatal Screening for Birth Defects. "Expanded AFP prenatal screening for birth defects" means the sequence of screening tests of initial and repeat blood tests and, where medically indicated, differential diagnostic screening tests and procedures authorized by the Department and provided by department-approved vendors. (d) Differential Diagnostic Screening Tests and Procedures. "Differential diagnostic screening tests and procedures" means those additional screening tests, methods, examinations or activities which are performed consequent to a positive blood screening test and which are used to distinguish between the presence of a birth defect of the fetus and other causes of positive blood screening tests. (e) Gestational Age. "Gestational age" shall be defined as the number of days elapsed since the first day of the last normal menstrual period. Gestational age may be calculated as the number of days from known or suspected conception plus 14 days or estimated by ultrasound examination and measurements. (f) Alpha-fetoprotein. "Alpha-fetoprotein" means the protein substance in maternal serum and amniotic fluid, the concentration of which is tested to determine the probability that the fetus has a neural tube defect. For the purpose of these regulations, alpha-fetoprotein may be abbreviated and referred to as "AFP," maternal serum alpha-fetoprotein may be abbreviated and referred to as "MS-AFP," and amniotic fluid alpha-fetoprotein may be abbreviated and referred to as "AF-AFP." (g) Analyte. "Analyte" means any constituent or substance the concentration of which is related to the presence of a birth defect and is analyzed and reported by prenatal screening laboratories as part of a departmentally provided or administered prenatal screening program including but not limited to alpha-fetoprotein, human chorionic gonadotrophin and estriol. (h) Method. "Method" means the steps and procedures used in a laboratory to measure the concentration of analytes in samples of maternal serum or amniotic fluid. Instruments, devices and reagents used are included in this definition. (i) Expanded AFP Prenatal Birth Defects Screening Laboratory. "Expanded AFP prenatal birth defects screening laboratory" means a laboratory approved by the Department to conduct prenatal screening laboratory tests to determine the concentration of analytes and perform other analysis related to birth defects specified as part of state administered testing. (j) Clinician. "Clinician" means physician, physician assistant, nurse midwife, nurse practitioner or any other person licensed or certified by the State to provide prenatal care to pregnant women or to practice medicine. (k) Prenatal Diagnosis Center. "Prenatal diagnosis center" means any facility in California which is approved by the Department to provide differential diagnostic tests and procedures for the prenatal evaluation or detection of genetic diseases, disorders, and birth defects of the fetus. (l) Initial Specimen. "Initial specimen" means the first adequate specimen collected from a pregnant woman pursuant to these regulations. (m) Initial Screening Positive Test. "Initial screening positive test" means an initial screening test of a specimen which gives a positive result as defined by the Department for reporting purposes pursuant to these regulations. (n) Inadequate Specimen. "Inadequate specimen" means a blood specimen collected from a pregnant woman which is not suitable in quality or quantity, was collected before the 105th or after the 140th day of gestation, or was not documented with the clinical information necessary for test result interpretation to perform valid prenatal screening for birth defects of the fetus. (o) Repeat Specimen. "Repeat specimen" means a blood specimen collected from a pregnant woman following the screening laboratory report that a previously collected blood specimen was either inadequate or that the screening test results were screening positive or inconclusive as defined by the Department. (p) An Expanded AFP follow-up vendor shall mean any facility, clinic, institution, health maintenance organization, or physician that: (1) submits documentation verifying that it meets the standards published by the Department for approval as a comprehensive prenatal diagnosis center entitled: Prenatal Diagnosis Center Standards and Definitions 1997. This document in its entirety is hereby incorporated by reference in this section; (2) has had the documentation verified by a state visit or; (3) has had experience in the provision of follow-up of women with abnormal MS-AFP results as defined by California's MS-AFP Program prior to April 1, 1992; and (4) receives notification of approval as a Prenatal Diagnosis Center; and (5) signs a vendor agreement to provide such services in accordance with Department policies including a fee schedule published by the Department entitled: Vendor Agreement March 1, 1996, and incorporated by reference in these regulations. The Department may obtain and provide reimbursement for any or all follow-up services authorized as the result of MS-AFP screening from any or all such approved vendors. Note: Authority cited: Sections 125000 and 125070, Health and Safety Code. Reference: Sections 124975-125050 and 125070, Health and Safety Code. s 6523. Expanded AFP Prenatal Birth Defects Screening Laboratories and Analytical Methods. (a) The Department shall approve Expanded AFP prenatal birth defects screening laboratories. Such laboratories shall be licensed as clinical laboratories under Division 2, Chapter 3 (commencing with Section 1200) of the Business and Professions Code. (b) Approved Expanded AFP prenatal birth defects screening laboratories shall be limited to the following: (1) A laboratory that shall have obtained a contract from the Department under applicable laws and regulations to provide laboratory services in sufficient volume to provide the prenatal birth defects screening test to all pregnant women in a designated geographic area defined by the Department, plus an emergency testing capacity that will be specified by contract. The Department will define not more than 6 geographic areas and may combine geographic areas if necessary to reduce costs or assure statewide coverage. (2) A laboratory exclusively serving a comprehensive prepaid group practice or health care service plan with 20,000 or more births in the last completed calendar year for which complete statistics are available may be approved for testing consistent with the terms of a mutually acceptable contract for services. (c) Expanded AFP prenatal birth defects screening laboratories approved by the Department shall comply with all laboratory standards for quality assurance issued by the Department and shall participate in a proficiency testing program approved and/or conducted by the Department and shall maintain levels of performance acceptable to the Department. (d) Analytical methods to be used in the measurement of each analyte concentration in maternal serum shall be designated and/or approved by the Department. (e) Analytical methods to be used in the measurement of the analyte concentration in amniotic fluid, and other adjunctive tests performed on amniotic fluid shall be designated and/or approved by the Department. Note: Authority cited: Sections 125000(e) and 125070, Health and Safety Code. Reference: Sections 124980, 125000(e) and 125070, Health and Safety Code. s 6525. Prenatal Diagnosis Centers and Laboratories. The Department shall approve prenatal diagnosis centers and prenatal diagnosis methods and Expanded AFP Birth Defect Screening Laboratories and laboratory methods and shall institute such quality control and proficiency testing as is necessary to assure the accuracy of testing. No laboratory shall offer or provide prenatal birth defect screening diagnostic tests on California residents without having obtained prior approval from the Department. Note: Authority cited: Sections 125050, 125055 and 125070, Health and Safety Code. Reference: Sections 124980, 125000 and 125070, Health and Safety Code. s 6527. Clinicians. (a) Clinicians shall provide or cause to be provided to all pregnant women in their care before the 140th day of gestation, or before the 126th day from conception, as estimated by medical history or clinical testing, information regarding the use and availability of prenatal screening for birth defects of the fetus. This information shall be in a format to be provided or approved by the Department and shall be given at the first prenatal visit and discussed with each pregnant woman. (b) The provisions of subsection (a) shall not apply if the pregnant woman has completed more than 140 days of gestation or 126 days post conception, as estimated by medical history or clinical testing, and this fact is entered in the medical record. (c) Clinicians shall cause to be provided to all pregnant women who, after being provided with the information pursuant to subsection (a), voluntarily request prenatal screening for birth defects of the fetus, the opportunity, the circumstances of which are to be documented in the medical record, to read and sign an informed consent document in a format provided or approved by the Department. (d) If the pregnant woman consents to testing, the clinician shall arrange for prenatal screening directly or by referral to another clinician by: (1) Fully and accurately completing all required specimen collection forms provided by the Department for this purpose; (2) Collecting or arranging for the collection of an initial specimen following state directions for collection provided; (3) As soon as possible, but within 24 hours of collection, place or cause to be placed all initial and repeat specimens in the channel of transmittal to the designated Expanded AFP prenatal birth defects screening laboratory. (e) Blood collection forms and blood collection and mailing kits supplied by the Department shall not be copied, printed, reproduced, acquired, purchased, substituted or distributed other than as specified for use in the Expanded AFP Prenatal Birth Defects Screening Program administered by the Department. (f) When notified that a blood specimen is inadequate for testing, the clinician shall make a reasonable effort to have an adequate specimen obtained as soon as possible but not more than five (5) days after such notification. (g) For each woman in their care who was prenatally screened for birth defects of the fetus and who has an initial screening positive test, the clinician shall: (1) Inform the woman that authorized follow-up services are available at Expanded AFP Follow-up Vendors, and that the program participation fees or laboratory test fee covers the authorized services. (2) Report on the form provided by the Department for this purpose, within 30 calendar days of the end of the pregnancy, the outcome of pregnancy and status of each fetus, or infant resulting therefrom. (h) The test results shall be confidential so that such information shall only be released with the knowledge and specific written consent of the woman tested. Persons authorized by the Department to conduct and monitor screening and/or to provide and monitor differential diagnostic follow-up services shall be provided information without necessity of specific written consent. (i) Recognizing the strict gestational and time limits wherein prenatal detection of birth defects of the fetus is feasible, clinicians shall make every reasonable effort to schedule screening and differential diagnostic tests and procedures appropriately with respect to the gestational dates of the pregnant woman. (j) Willful or repeated failure to comply with these regulations shall be referred by any person having knowledge of noncompliance to the appropriate licensing authority. Note: Authority cited: Sections 125000 and 125070, Health and Safety Code. Reference: Sections 124980 (b), (c), (d), (h), (j) and 125070, Health Safety Code. s 6529. Program Participation Fee. (a) The Department shall collect an all-inclusive program participation fee for each screening service program. Effective March 1, 1998, the fee for maternal serum alpha fetoprotein, used as a single marker to screen neural tube defects only, shall be fifty-seven (57) dollars. Effective March 1, 1998, the fee for maternal serum alpha fetoprotein and one or more additional markers used for screening for NTD and Down Syndrome, shall be one hundred and five (105) dollars. The fee shall be paid to the Department by the woman being tested or by any third party which is legally responsible for her care including any health care service plan, managed health care plan, managed care plan, prepaid health plan or prepaid group practice health care service plan as defined in or licensed in accordance with Health and Safety Code section 1340 et seq. (b) Health care providers which contract with a prepaid group practice health care service plan that annually has at least 20,000 births among its membership, may provide, without contracting with the Department, any or all of the testing and counseling services required to be provided under this section, if the services meet quality standards established by the Department and the plan pays that portion of a fee established under this section which is directly attributable to the Department's cost of administering the testing or counseling service and any required testing or counseling services provided by the state for plan members during the previous fiscal year. This option must be executed under terms of a written agreement. Payment by the plan shall be deemed to fulfill any obligation the provider or the provider's patient may have to the Department to pay a fee in connection with the testing or counseling service. Note: Authority cited: Sections 125070 and 125000(h)(j), Health and Safety Code. Reference: Sections 125000(b), (f), 125005, 125050, 125055, 125060 and 125065, Health and Safety Code. s 6531. Reporting of Neural Tube Defects. (a) All cases of neural tube defect in a fetus or an infant under one year of age shall be reported to the Department. Neural tube defects shall mean any malformation of the fetus caused by the failure of the developing spine and skull to properly close. (b) This report shall be made: (1) By the health facility in which the case is initially diagnosed; (2) By the physician making the initial diagnosis if the case is not diagnosed in a health facility; (3) Within 30 calendar days of the initial diagnosis; (4) On the form to be provided by the Department for this purpose. Note: Authority cited: Section 289.7, Health and Safety Code. Reference: Section 289.7, Health and Safety Code. s 6532. Reporting of Chromosomal Disorders. (a) All cases of Down's syndrome or other chromosomal defects in a fetus or an infant under one year of age shall be reported to the Department. Chromosomal defects shall mean any abnormality in structure or number of chromosomes. (b) This report shall be made: (1) by the cytogenic laboratory performing the chromosomal analysis or by the physician making the diagnosis; (2) within 30 calendar days of the initial diagnosis; (3) on a form to be provided by the Department for this purpose. Note: Authority cited: Section 309, Health and Safety Code. Reference: Section 309, Health and Safety Code. s 6600. Employee. An employee of the school is a person on the school's payroll, part time or full time. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 3450-3455, Health and Safety Code. s 6601. Volunteer. A volunteer is a person not on the school's payroll who meets the following criteria: (a) contributes time and services in support of the school's operation, (b) whose work is regularly scheduled by the school on a continuing basis at least once monthly, and (c) who works on the school premises during school hours. s 6602. Private and Parochial Schools. Private and parochial schools are schools offering elementary and secondary daily education in any of the grades, kindergarten through twelfth. s 6603. Nursery School. Nursery school is any school receiving and caring for one or more children of preschool age on a partial or full time basis. s 6604. Elementary School. Elementary school is any school offering instruction in any of the grades kindergarten through eighth. s 6605. Secondary School. Secondary school is any school offering instruction in any of the grades, ninth through twelfth. s 6606. Minimum Examination. Minimum examination required is a chest X-ray or the approved skin test. If the tuberculin test is positive (10 mm. or over), it must be followed by a chest X-ray. Private physicians, local health departments or local Tuberculosis and Health Associations may provide these tests and X-rays. s 6607. Approved Skin Test. Approved skin test is the intradermal Mantoux 5 TU (.0001 mgm) PPD. s 6608. Records as Evidence of Compliance. A school will have satisfactorily complied with the requirements of the law if by two weeks after the opening of the school year the school administrator provides the local health officer with a statement certifying (a) the number of persons employed, (b) the number of volunteers, and (c) that the required certificate for each, signed by a physician licensed to practice medicine in California, or a notice from a public health agency or unit of the Tuberculosis and Health Association indicating freedom from active tuberculosis is on file and available for verification. Thereafter, the legal requirements will be met by obtaining the certificate prior to or within two weeks of date of employment, or acceptance of a volunteer, and repeating every two years. s 6701. Application and Scope. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6702. Time Limitation for Training. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6705. Definitions. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6710. Scope of Course. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6711. Required Topics. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6712. Special Requirements. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6714. Testing. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6715. Validation of Course Completion. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6716. Retraining Requirements. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6720. Course Approval. Note: Authority cited: Sections 208(a) and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6721. Additional Requests for Designation. Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. s 6722. Program Review. [FNa1] Renumbered from Subchapter 11 (Register 74, No. 52). Note: Authority cited: Sections 208 and 217, Health and Safety Code. Reference: Section 217, Health and Safety Code. Note: Authority cited: Sections 208 and 1760, Health and Safety Code. Additional authority cited: Section 1760.5, Health and Safety Code. Reference: Sections 1760 and 1760.5, Health and Safety Code. s 6800. Health Assessment. (a) "Health assessment" means the following: (1) A comprehensive health and developmental history, and a physical examination. (2) Appropriate health screening procedures and immunizations. (3) Evaluation of results in terms of needed diagnosis and treatment. (4) Providing the person screened with a copy of the results and an explanation of their meaning. (5) Health education appropriate to the person's age and health status, including anti-tobacco use education. Note: Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 321.2, 324 and 24165.3, Health and Safety Code. s 6801. Community. "Community" means an individual county, or a city and county, or counties acting jointly, or a city which operates an independent health agency. In the instance of a city providing the services described in this subchapter, the powers granted a governing body of a county to operate a child health and disability prevention program shall be vested in the governing body of that city. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6802. Community Child Health and Disability Prevention Program. (a) "Community child health and disability prevention (CHDP) program" means a community based and operated program of activities, approved and funded by the Department, necessary to comply with federal and state legislation and regulations that require: (1) CHDP services to be made available to Medi-Cal beneficiaries from birth to 21 years of age, and to be reimbursed by the State. (2) Health assessment and referral to diagnosis and treatment services to be made available to (1) children who are not Medi-Cal beneficiaries from birth until 90 days after entrance into the first grade, and (2) all persons under 19 years of age whose family income is not more than 200% of the federal poverty level. State reimbursement of the costs of health assessment and referral to diagnostic and treatment services for these children is limited by the amount of funds appropriated by the Legislature, and is made available only for those children who meet the age and family income criteria defined by the State Department of Health Services' Child Health and Disability Prevention Program. (3) Children entering first grade to present a certificate within 90 days after entrance that they have received health assessment within the prior 18 months. A waiver signed by the child's parent or guardian indicating that they do not want or are unable to obtain such health assessment and evaluation services for their children shall be accepted in lieu of the certificate. Note: Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 320 and 24165.3, Health and Safety Code. s 6804. Contract Counties. "Contract counties" means those counties which contract with the Department for health services and which have not elected to provide the services themselves. The Department is responsible for the child health and disability prevention programs in those counties. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6806. Department. "Department" means the State Department of Health Services. Note: Authority cited: Sections 208, 320.2 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6808. Diagnosis. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6810. Director. "Director" means the Director of the State Department of Health Services, unless otherwise specified. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6812. Governing Body. "Governing Body" means, except where indicated otherwise in this subchapter, the county board of supervisors, or boards of supervisors in the case of counties acting jointly or the city council in the case of a city. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320 et seq., Health and Safety Code. s 6813. Initiation of Treatment. "Initiation of treatment" means the first encounter for treatment of the medical and the dental problems disclosed during the health assessment. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 323.7, Health and Safety Code. s 6814. Medi-Cal Beneficiary. (a) "Medi-Cal beneficiary" means an individual under 21 years of age who is eligible for and certified to receive services under provisions of the California Medical Assistance Program (Chapter 7 of Part 3 of Division 9 of the Welfare and Institutions Code, beginning with Section 14000). Medi-Cal beneficiaries include: (1) Persons who are certified eligible to receive cash grants under one of the public assistance programs. (2) Persons who are certified eligible to receive medically needy or medically indigent Medi-Cal benefits. (3) Other persons who are certified eligible to receive noncash grant Medi-Cal benefits. Other persons include the following: (A) Children not in school and not in training. (B) Persons receiving in-home supportive services. (C) Persons who have lost AFDC eligibility, but are continuing to receive Medi-Cal benefits for four months from the date of lost eligibility. (D) Persons who were discontinued from cash grants solely due to a 20 percent Social Security increase in 1977. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6816. Person. "Person" means anyone from birth to 21 years of age eligible to receive services specified in this subchapter. Persons include newborns, infants, children, youth, emancipated minors, young adults and adults. In those instances where the person is not an adult or an emancipated minor, "person" means the person, or his/her parent(s) or guardian(s). Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6817. Clinical Laboratory. "Clinical Laboratory" means a facility for examining and testing specimens for the purpose of obtaining scientific data which may be used to ascertain the presence, progress, and source of disease in human beings. Note: Authority cited: Sections 208 and 321, Health and Safety Code; Section 14105, Welfare and Institutions Code. Reference: Section 320, Health and Safety Code; Section 14132, Welfare and Institutions Code; and Section 655.6, Business and Professions Code. s 6818. Screening. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6819. Child Health and Disability Prevention Services in Contract Counties. The organizational unit within the Department which is responsible for health services in contract counties shall develop annual plans and budgets, and shall conduct a program which is acceptable to the Child Health and Disability Prevention Program, and which is in accordance with the provisions of this subchapter. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 321.2, Health and Safety Code. s 6820. Advisory Boards. (a) Membership. Membership in an advisory board shall be as follows: (1) Members appointed to the local advisory board by the local governing body shall include, but not be limited to, individuals who, at the time of their appointment, are representatives of health professions concerned with child health, school health personnel and parents of children eligible to receive services under provisions of this subchapter, whether or not the services are eligible for state reimbursement. (2) The governing body may recognize individuals as alternates who have professional or parent qualifications equivalent to that of the member. (3) The governing body shall not appoint any employee of the local health department to the advisory board, except that the director and deputy director of the community child health and disability prevention program shall be ex officio, nonvoting members of the board. (4) Individuals appointed to the advisory board as parents of children eligible to receive services shall neither be employed by an individual or an agency providing health services to the public for fee, nor be a provider of health services to the public for fee. (b) Responsibilities. The local advisory board shall be responsible for the reviewing, advising and reporting functions related to the community child health and disability prevention program as specified in Section 321.7, Health and Safety Code. The advisory board may also advise the local governing body and appropriate governmental agencies on health matters additional to the community child health and disability prevention program, such as maternal and child health in general. (c) Tenure. Members of the advisory board shall serve at the pleasure of the appointing authority for a term of three years, except that one-third of the members first appointed in each jurisdiction shall serve for three years, one-third of the members for two years and one-third of the members for one year. (d) Meetings. The advisory board shall meet at least twice each year, once before March 1, and once after March 1 but before September 1. In addition, the board shall meet on the call of the chairperson of the board or on the call of one-third of its members. Public notice shall be given of the date, time and location of each meeting in advance of the meeting. Meetings shall be open to the public. (e) Reimbursement. Advisory board members and alternates shall serve without compensation, except that members, and alternates when acting in lieu of members, shall be reimbursed under the approved community plan for actual and necessary expenses incurred in connection with the performance of their duties. Parent members may additionally be reimbursed for their actual and necessary costs of child care and lost wages. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 321.7, Health and Safety Code. s 6822. Director and Deputy Director. (a) Designation. Each governing body, except those in contract counties whose programs are administered by the Department, shall appoint a physician, licensed to practice medicine in California, as Director, Child Health and Disability Prevention Program. The director shall have administrative responsibility for the organizational unit concerned with child health in the local health department as defined in Section 1102, Health and Safety Code. If the director is an existing health official, the director or local appointing authority shall also appoint a Deputy Director, Child Health and Disability Prevention Program, with experience in the delivery of health services to children and youth who is assigned to the organizational unit for which the Director, Child Health and Disability Prevention Program, has direct administrative responsibility. (b) Responsibilities. The responsibilities of the director shall include, but not be limited to: (1) Developing and implementing the community child health and disability prevention program plan and assuring its compliance with federal and state regulations. To the extent possible, this plan should relate to all community health services for children and youth, and to the integration and coordination of these services with the community's child health and disability prevention program. (2) Managing funds granted under the state-approved community plan. (3) Completing all reports and maintaining all records required by the Department. (4) Providing support staff and services to the community child health and disability prevention advisory board. (5) Preparing an annual report to the governing body. (c) Reimbursement. The salary and necessary expenses of the community child health and disability prevention program director or deputy director may be reimbursed by the State under the approved community plan to the extent that the services are directly related to the community child health and disability prevention program. However, if the director is a health officer as defined in Sections 451, 502 or 940 of the Health and Safety Code, no funds from this program shall be used directly or indirectly for reimbursement of the health officer's services rendered to the program. If the director is an existing health official other than the health officer, the official's salary may be reimbursed to the extent the official renders services to the program as indicated in the program's approved annual plan and budget. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321(a) and 322, Health and Safety Code. s 6824. State and Local Responsibilities. (a) Annual plan and budget. On or before March 15 of each year, each governing body shall submit to the Department's Child Health and Disability Prevention Program the following: (1) A summary of the previous fiscal year's activity ending the previous June 30. (2) A summary of the current fiscal year's activity from the previous July 1 to the date of the revised budget submittal. A projection of activities from the date of the revised budget submittal through June 30 of the current fiscal year is desirable, but optional. (3) A description of the community program to be offered the next fiscal year, including expected program performance goals and activities. Descriptive material submitted as part of a previously state-approved plan need not be repeated. If the community child health and disability prevention program plan is part of the community's more comprehensive child health plan, the more comprehensive plan may be submitted in lieu of a separate community child health and disability prevention program plan. (4) A budget for the next fiscal year beginning July 1. (A) The community child health and disability prevention program budget for the budget year shall be limited to those items, including equipment and remodeling, required to implement the plan approved by the Department's Child Health and Disability Prevention Program. (B) If the amount appropriated in the State Budget Act and enacted into law for the budget year differs from the amount in the budget submitted by the Governor, each local governing body shall submit to the Department's Child Health and Disability Prevention Program an additional revised plan and budget that reflects the share of the reduction determined by the Director to be applicable to that community child health and disability prevention plan. (5) A preliminary budget estimate for the following fiscal year beginning the following July 1. (6) A current agreement between the community child health and disability prevention program and the county welfare department relating to the provision and documentation of child health and disability prevention services to Medi-Cal beneficiaries and setting forth the responsibilities of the community program and the county welfare department to assure adequate informing, outreach, referral and follow-up. (7) Other information which may be required by the Department's Child Health and Disability Prevention Program. (b) Informing Medi-Cal beneficiaries. Medi-Cal beneficiaries shall be informed as follows: (1) No later than 60 days following the date of a family's initial Medi-Cal eligibility determination or of determination after a period of ineligibility, the family must be informed of the availability of CHDP services including dental services. This must be done in writing and using face-to-face contact by a person who can explain these services and benefits. A family who loses and regains eligibility more than twice within a twelve-month period need not be informed more than twice in that twelve-month period. Informing includes the offer of services, assistance with scheduling appointments and transportation, and documenting responses. (2) If no member of an eligible family participates in the program, the family must be informed in writing at least once each year beginning October 1, 1980. Informing includes offering CHDP services, offering assistance with transportation and scheduling appointments, and documenting responses. (3) Each of the following must be used to inform an eligible family: (A) Clear, nontechnical materials for those families who are to be informed in writing. (B) Procedures suitable for informing persons who are illiterate, blind, deaf, or cannot understand the English language. (4) A family being informed about the program must be given the following information: (A) The benefits of preventive health and dental services. (B) How medical and dental services can be obtained. (C) How specific information can be obtained on the location of the nearest providers participating in the program. (D) The health assessment and dental services that are offered. (E) A summary of the State's periodicity schedule. (F) That recipients can receive both initial and periodic health assessments and dental services according to the State's periodicity schedule. (G) That treatment services shall be provided for problems disclosed during screening. (H) That assistance in referral shall be provided. (I) That assistance with transportation shall be provided if the person requests it. (J) That assistance in scheduling appointments shall be provided if the person requests this assistance. (K) That as long as the person remains eligible for Medi-Cal, he or she may request these services at any time in the future if the decision is postponed at the time of initial informing. (L) That the person may choose to receive CHDP services from a provider of the person's choice, and that if the provider does not offer the full range of CHDP services specified in this subchapter, the person can receive the services not offered if the person makes a request to the community CHDP program or welfare department. If such request is made, assistance in scheduling appointments and transportation shall be offered, and the responses documented. (M) That these CHDP services are available from approved providers at no cost to the family. (c) Information and training for county welfare employees. Information and training for county welfare department personnel shall be as follows: (1) The State Departments of Health Services and Social Services shall provide information, training and materials necessary to ensure that county social services and welfare eligibility personnel, and other appropriate welfare department employees, are fully informed as to the purpose, nature, scope and benefits of CHDP services. (2) Such employees shall be trained in methods of information dissemination that will encourage and motivate eligible individuals to make use of such preventive medical programs. (3) The provision of such training shall be verified in appropriate sections of the annual plans submitted to the Department's Child Health and Disability Prevention Program by community child health and disability prevention programs. (d) Information and training for local health department personnel. Information and training for local health department personnel shall be as follows: (1) The Department shall provide such information, training and materials necessary to ensure that appropriate local health department personnel and other appropriate county and municipal employees are informed as to the purpose, nature, scope and benefits of CHDP services. (2) Such employees shall be trained in methods of information dissemination that will encourage and motivate eligible individuals to make use of such preventive medical programs. (3) The provision of such training shall be verified in appropriate sections of the annual plans submitted to the Department's Child Health and Disability Prevention Program by community child health and disability prevention programs. (e) Required services. Each community child health and disability prevention program shall provide, in accordance with this subchapter, at least the following services: (1) Outreach and health education, including anti-tobacco use education. (2) Referral to dentist. (3) Referral to a health assessment. (4) Health assessment. (5) Certification for school entry. (6) Referral to diagnosis and treatment. (7) Diagnosis and treatment. (f) Records and information. Each community child health and disability prevention program shall keep records and provide information on the results of health assessments and follow-up to diagnosis and treatment, and other data about the persons served as may be required by the Department's Child Health and Disability Prevention Program. (g) Other responsibilities. The Department shall provide the following: (1) Regulations and minimum standards for quality preventive health services for children and youth, including anti-tobacco use education guidelines. (2) Consultation services on all aspects of community program development. (3) Appropriate data collection and reporting forms. (4) Documentation and data, made available at the state or local level, on all aspects of the program including: (A) The results of informing services. (B) The results of screening services. (C) The results of diagnosis and treatment services. (D) The results of anti-tobacco education services. (5) Management reports for state and local program use. (6) Reports required by the federal Early Periodic Screening Diagnosis and Treatment Program. Note: Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 320, 321.2, 322.5, 324 and 24165.3, Health and Safety Code. s 6826. State and Local Information and Training Responsibilities. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6828. Sanctions for Noncompliance. (a) If the Chief of the State Child Health and Disability Prevention Program determines that a reasonable period of technical consultation and assistance has been provided or arranged for by the State Child Health and Disability Prevention Program, and further determines that a community child health and disability prevention program director fails to comply with any state or federal law or regulation governing child health and disability prevention services, or with the approved community plan, the Chief of the State Child Health and Disability Prevention Program shall notify the local governing body in writing of the specific areas of noncompliance. A copy of the notice shall be sent to the community pro gram director, the county welfare department director, and to the local child health and disability prevention program advisory board. (b) If the local governing body fails to provide substantial evidence to the Chief of the State Child Health and Disability Prevention Program within 30 days that the community program director is complying and shall continue to comply with the laws, regulations and the approved community plan, the Director shall convene a hearing for the community program to show cause why the Director should not take action to secure compliance. The Director shall invite the community child health and disability prevention program's advisory board and other persons or organizations interested in the community's child health and disability prevention program to present comments at such hearing. The Department shall give the community program, concerned individuals and organizations, and the general public at least 15 days notice of such hearing. (c) The Director shall consider the case on the record established at the hearing and render findings and decision on the issues within 30 days following the hearing. The findings and decision shall be submitted in writing by the Director to the local governing body. A copy of the notice shall be sent to the community program director, the county welfare department director, and to the local child health and disability prevention program advisory board. (d) If the Director determines that there is a failure on the part of the community child health and disability prevention program to comply with any state or federal law or regulation governing child health and disability prevention services, or the approved community plan, the Department may invoke any of the following sanctions: (1) Consistent with federal and state law, withhold part or all of state and federal funds from such community until the local governing body provides written documentation of compliance to the Director. (2) Bring an action in mandamus or such other action in court as may be appropriate to compel compliance. (e) Nothing in this section shall be construed as relieving the local governing body of the responsibility to provide funds necessary to continue the child health and disability prevention services required by Sections 320, et seq., Health and Safety Code. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6830. Eligibility for Services. (a) Medi-Cal beneficiaries shall be eligible for periodic health assessments, and for diagnosis and treatment, if necessary, in accordance with the provisions of this subchapter. (b) Any child (1) between birth and 90 days after entrance into the first grade who is not a Medi-Cal beneficiary and (2) all persons under 19 years of age whose family income is not more than 200 percent of the federal poverty level shall be eligible for health assessments in accordance with the provisions of this subchapter. Availability of services and reimbursement for these services shall depend on the amount of funds appropriated by the Legislature for the services as specified in section 6832(b). Note: Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 322.5, 323.7 and 24165.3, Health and Safety Code. s 6832. Eligibility for Reimbursement. (a) The costs of periodic health assessments provided to Medi-Cal beneficiaries shall be reimbursed by the State in accordance with the schedule of maximum allowances specified in section 6868. (b) If the amount of funds appropriated in the State Budget Act are sufficient, the costs of health assessments provided to (1) children between birth and 90 days after entrance into the first grade, who are not Medi-Cal beneficiaries, and (2) all persons under 19 years of age whose family income is not more than 200 percent of federal poverty level shall be reimbursed by the State. To the extent that funds are not sufficient, these costs shall be reimbursed only for those children who meet the age and family income criteria defined by the Department's Child Health and Disability Prevention Program. (c) The costs of diagnosis and treatment services provided to Medi-Cal beneficiaries as a result of health assessments shall be reimbursed by the State in accordance with the Medi-Cal fee schedules, subject to any applicable Medi-Cal program limitations. Note: Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 322.5, 323.2 and 24165.3, Health and Safety Code. s 6840. Required Services. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2 (a)-(e), Health and Safety Code. s 6842. Outreach and Health Education. (a) Plan. Each community child health and disability prevention program shall develop, plan and implement community outreach and health education activities which are related to the community's needs and resources. Activities may include, but are not limited to, community organization, staff training, consultation with children and families, staff services to community child health and disability prevention program advisory boards, and the development and dissemination of informational and educational material for the public, potential users and providers of the program's services, advisory board members, local agencies and community groups. (b) Outreach. An outreach program shall be as follows: (1) Community child health and disability prevention programs shall develop outreach programs to involve persons in the use of preventive health services. Outreach and health education services shall be designed to ensure that the only reason eligible persons do not participate in the health assessment and referral for diagnosis and treatment portions of the program is because they intelligently and knowingly decline such participation for reasons unrelated to availability and accessibility of the health assessment, diagnosis and treatment services. (2) In cooperation with the community child health and disability prevention program, the governing body of every school district or private school which has children enrolled in kindergarten shall, at the time the parent or guardian registers a child in kindergarten, inform the parents or guardians as follows: (A) It is statutorily required that children provide, within 90 days after entrance into the first grade, either a certificate to the school documenting that within the prior 18 months the child has received the appropriate health assessment required by law, or a waiver signed by the parent or guardian indicating that they do not want or are unable to obtain such health assessments for their children. (B) The health assessment that is required is available from the child's usual source of health care, the local health department, some schools and other places in the community. (C) Rather than wait until the child actually enters first grade, it is advisable to get the health assessment as early as possible, preferably within six months prior to kindergarten entrance, at which time it is also required that the child's immunizations (a part of the total health assessment) be brought up to date. (3) The parents or guardians of children entering the first grade who do not have documentation that the appropriate health assessment has been done or waived shall be informed by the school at that time as follows: (A) It is statutorily required that children provide, within 90 days after entrance into the first grade, either a certificate to the school documenting that within the prior 18 months the child has received the appropriate health assessment required by law, or a waiver signed by the parent or guardian indicating that they do not want or are unable to obtain such health assessments for their children. (B) The health assessment that is required is available from the child's usual source of health care, the local health department, some schools and other places in the community. (c) Informing. Persons eligible to receive CHDP services shall be informed, using effective methods to involve them and in a language understandable to them, about the following: (1) The value of preventive health services. (2) Health assessments. (3) The need for prompt diagnosis and appropriate treatment of suspected disabilities. (4) The nature, scope and benefits of the Child Health and Disability Prevention Program. (d) Health Education. Health education, including anti-tobacco use education, shall be an integral part of the health assessment. Note: Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 321.2, 323.5, 324.2 and 24165.3, Health and Safety Code. s 6843. Referral to Dentist. (a) Availability. (1) A direct referral to a dentist shall be made for eligible Medi-Cal beneficiaries three years of age and older unless dental services have been declined. The dental referral is for the purpose of diagnosis and treatment. Dental treatment consists of dental care needed for relief of pain and infections, restoration of teeth and maintenance of dental health. (2) An inspection of the teeth, gums and mouth is part of the health assessment, and referral to a dentist shall be made if appropriate. (b) Informing and training responsibilities. The provisions of Section 6824 also apply to the information and training responsibilities of the state and community child health and disability prevention programs regarding informing Medi-Cal beneficiaries of the availability of dental services, how the services may be obtained, and of the assistance available with transportation and scheduling appointments. (c) Frequency. An annual referral to a dentist for dental services shall be offered each eligible Medi-Cal recipient three years of age and older. Dental providers, approved for participation in the Medi-Cal program, shall be reimbursed for diagnosis resulting from this annual referral, and for dental care needed for relief of pain and infections, restoration of teeth and maintenance of dental health. (d) Offer of assistance with transportation and scheduling appointments. Medi-Cal beneficiaries shall be offered assistance with transportation and scheduling appointments for initial and periodic dental examinations. The response to this offer shall be recorded, and this assistance shall be provided if requested by the beneficiary. (e) Completion of referral. All reasonable steps shall be taken to ensure that Medi-Cal beneficiaries eligible to receive an initial or a periodic dental examination, and who request a referral, complete the referral. An initial dental examination shall normally be completed within 120 days from either the date the beneficiary requests the referral, or the date the beneficiary was certified eligible to receive Medi-Cal benefits, whichever occurs later. A periodic dental examination shall normally be completed within 120 days from either the date the beneficiary requests the referral, or the last day of the month in which the annual dental examination was due, whichever occurs earlier. (f) Referral sources. The first source of referral for dental services shall be the person's usual source of licensed dental care. If no usual source of licensed dental care can be identified, the person shall be given, without prejudice for or against any one source, the names and locations of at least three sources of dental care, when available, which have been approved as providers of dental services by the California Medical Assistance Program. Although the family or recipient may choose to receive dental diagnostic and treatment services from a provider of its choice, to be eligible for state reimbursement, these services shall be provided by Medi-Cal approved providers and in accordance with the provisions of the California Administrative Code, Title 22, Division 3 and subject to any applicable Medi-Cal program limitations. (g) Documentation. If initial or periodic dental services were not provided to a Medi-Cal beneficiary who had requested such services and who also had requested assistance with transportation or scheduling appointments for services, documentation must exist showing that the family or person lost eligibility, could not be located despite a good faith effort to do so, or the person's failure to receive the services was due to an action or decision by the family or person, rather than a failure by the community child health and disability prevention program to meet requirements of this subchapter, including the requirement to offer and provide assistance with transportation and scheduling appointments for services. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2, 322.7 and 323.7, Health and Safety Code. s 6844. Referral to Health Assessment. (a) The following shall apply to all persons eligible to receive health assessments under the provisions of this subchapter: (1) All reasonable steps, including assistance in scheduling and completing appointments if requested, and in following up initial efforts, shall be taken to ensure that persons eligible to receive health assessments, and who request a health assessment, receive it. (2) Appointments for requested health assessments shall be completed in a reasonable period of time, normally not to exceed 60 days. (3) The first source of referral for a health assessment shall be the person's usual source of health care. Preference should be given to the comprehensive care provider. If no usual source of health care can be identified, the person shall be given, without prejudice for or against any one provider, the names and locations of at least three providers, when available, who have been approved as providers of health assessments by the community child health and disability prevention program director. The availability of health assessments directly from the clinic operated by the community program may also be made known to the person. (4) Although a person may choose to receive a health assessment from a provider of the person's choice, to be eligible for state reimbursement, the health assessment shall be provided by providers who have been approved to bill the Department for these services. (b) Additional to (a), above, the following shall apply to Medi-Cal beneficiaries who request health assessments: (1) Medi-Cal beneficiaries shall be offered assistance with transportation and scheduling health assessment appointments. The response to this offer shall be recorded, and this assistance shall be provided if requested by the beneficiary. (2) If a person chooses to receive a health assessment from a provider that does not furnish the full range of services as specified in this subchapter, the community child health and disability prevention program shall, if requested, provide or arrange for provision of all such services that are not offered by that provider. At the time of the request, the person must be offered assistance with transportation and scheduling appointments. The response to this offer shall be recorded, and this assistance shall be provided if requested. (3) If an initial or a periodic health assessment is not provided to a Medi-Cal beneficiary who requests such services and who also requests assistance with transportation or scheduling appointments for services, documentation must exist showing that the family or person lost eligibility, could not be located despite a good faith effort to do so, or the person's failure to receive the services was due to an action or decision by the family or person, rather than a failure by the community child health and disability prevention program to meet requirements of this subchapter, including the requirement to offer and provide assistance with transportation and scheduling appointments for services. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2 (d) and 323.7, Health and Safety Code. s 6846. Health Assessment. (a) Conditions. The following conditions apply to health assessments provided to eligible persons: (1) A health assessment shall not be provided without the voluntary consent of the patient. (2) A health assessment shall not be provided to minors without the prior and written consent of the minor's parent or guardian unless one or more of the following circumstances exist: (A) The minor is emancipated. (B) The minor is married. (C) The minor is a member of the military forces. (D) Provision of the service is exempted from parental consent by federal or state statute or regulation. (b) Required screening procedures. Unless medically contraindicated or deemed inappropriate by the health assessment provider, or refused by the person, health assessments shall include the following procedures: (1) Health and developmental history. (2) Unclothed physical examination including assessment of physical growth. (3) Assessment of nutritional status. (4) Inspection of ears, nose, mouth, throat, teeth and gums. (5) Vision screening. (6) Hearing screening. (7) Tuberculin testing and laboratory tests appropriate to age and sex, including tests for anemia, diabetes and urinary tract infections. (8) Testing for sickle cell trait and lead poisoning where appropriate. (9) Immunizations appropriate to age and health history necessary to make status current. (Patient shall also receive, subsequent to the health assessment, any immunizations which could not be given during the assessment, and any immunizations necessary to complete a series which could not be completed during the assessment.) (10) Health education and anticipatory guidance appropriate to age and health status. (c) Additional screening procedures. A community child health and disability prevention program may include screening procedures in its program, additional to the ones included in this section, if these procedures are approved by the Department and the State Child Health Board. (d) Rechecks. In those instances where a person is eligible for state reimbursement of health assessment costs, reimbursement may be made for one recheck of those screening procedures (excluding the Health History and Physical Examination) and laboratory tests where such a recheck is medically indicated because questionable or marginal results were obtained during the prior screening. (e) Results of health assessment. The results of the health assessment shall be handled as follows: (1) Health assessment providers shall provide the person with a copy of the results of the screening tests, with an appropriate explanation of the results. Such notification and discussion of screening test results, unless provided by a licensed or certified practitioner of the healing arts, shall be free of diagnostic statements or suggestions that the person needs any particular treatment. Specifically, no medical care or special education plan shall be instituted solely on the basis of the health screening results. (2) The results of the health assessment shall be recorded on forms provided by the Department. (f) Concurrent diagnosis and treatment. Nothing in these regulations shall be interpreted to mean that a licensed or certified practitioner of the healing arts may not provide diagnosis and treatment, in conjunction with the health assessment, if medically indicated. (g) Nonspecified procedures. Health screening procedures that are approved for reimbursement by the Department are specified, together with their maximum allowable reimbursements, in Section 6868. Reimbursement for procedures not specified in Section 6868 shall not be made without written approval of the Department. Note: Authority cited: Sections 208, 321 and 323.7, Health and Safety Code. Reference: Sections 321.2 and 324, Health and Safety Code. s 6847. Periodicity of Health Assessments. (a) Eligibility. Medi-Cal beneficiaries who have received an initial health assessment are also eligible for subsequent, periodic health assessments. (b) Notifying and Offering Assistance. Persons eligible for periodic assessments shall be notified before each assessment is due of their entitlement to the assessment, and of the availability of assistance with transportation and scheduling appointments. The informing may be in writing. The response to this offer shall be recorded, and this assistance shall be provided if requested by the beneficiary. (c) Frequency. Persons eligible for periodic health assessments shall receive one assessment during each age period listed below. The first age at which the next health assessment is due is the age of the person at the previous assessment plus the interval indicated in the parenthesis after that age period in the table shown in this subsection. However, a periodic assessment may be done at any time from the beginning to the end of each age period. Persons will be considered overdue for an assessment on the first day he or she enters a new age period without assessment having been performed in the previous age period. For example, a child receiving an assessment at two and one-half years of age is first due for the next assessment at three and one-half years of age (the age at the time of previous assessment, two and one-half plus the time interval between assessments for that age group, one year). The assessment is overdue when the child is four years old. There is no time interval in the 17-20 age period because no additional assessments will be given after that assessment. Initial and periodic assessments, and the initiation of any needed treatment, shall normally be completed within 120 days from either the last day the person is eligible for assessment in any age period or the day the person is notified that the next assessment is due, whichever occurs first. The following table is a guide for the minimum frequency at which health assessments shall be provided to persons eligible for periodic assessments: Under 1 month old........... (1 month) 1 through 2 months old...... (2 months) 3 through 4 months old...... (2 months) 5 through 6 months old...... (2 months) 7 through 9 months old...... (3 months) 10 through 12 months old.... (3 months) 13 through 17 months old.... (5 months) 18 through 23 months old.... (6 months) 2 years old................. (1 year) 3 years old................. (1 year) 4 through 5 years old....... (2 years) 6 through 8 years old....... (3 years) 9 through 12 years old...... (4 years) 13 through 16 years old..... (4 years) 17 through 20 years old (d) Additional Health Assessments. The frequency indicated in this section is considered a minimum for preventive health care. More frequent health assessments will be reimbursed when the additional assessment is deemed appropriate by the health assessment provider. Circumstances which may indicate the need for more frequent assessments include the following: (1) The parents have or the person has a particular need for education and guidance. (2) There is the presence or possibility of perinatal disorders (such as low birth weight, low Apgar scores at birth, prolonged labor). (3) The person is or will be exposed to a potentially stressful environment - for example, camp or contact sports -before the next periodic health assessment indicated by the periodicity schedule is due. (e) Limitations. Reimbursement at more frequent intervals will not be made for a health assessment of an individual for the purpose of monitoring or treating a specific disease or disorder previously diagnosed, or for a person whose overall health status requires ongoing treatment care. Such individuals are still eligible for regular assessments if they are otherwise eligible for CHDP services. Note: Authority cited: Sections 208, 321 and 323.7, Health and Safety Code. Reference: Sections 320 and 323.7, Health and Safety Code. s 6848. Certification for School Entry. (a) If a child receives a health assessment under provisions of this subchapter, and must present documentation to the school in which the child is to enroll that the appropriate health screening procedures specified in Section 6846 have been performed, the physician, certified pediatric nurse practitioner or certified family nurse practitioner providing or supervising such screening shall give the child or parent or guardian a certificate documenting that the child has received the appropriate health screening procedures. The certificate shall be provided whether the cost of the health assessment is reimbursed by the State or paid on behalf of the child. (b) A child may be certified for school entry by the child's personal physician, certified pediatric nurse practitioner or certified family nurse practitioner without receiving a further health assessment if the child has received a physical examination and ongoing comprehensive medical care from that physician, certified pediatric nurse practitioner or certified family nurse practitioner during the 18 months preceding entry into the first grade, or within 90 days thereafter, and that care has included all the applicable health screening procedures outlined in Section 6846. (c) The health certification for school entry shall be on the form provided by the Department, Report of Health Examination For School Entry, PM171A(6/84). Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 323.5, Health and Safety Code; Section 14132.41, Welfare and Institutions Code; and Sections 2834, 2835, 2835.5 and 2836, Business and Professions Code. s 6850. Referral to Diagnosis and Treatment. (a) The following shall apply to all persons for whom diagnosis and treatment is indicated as a result of initial or periodic health assessments received under the provisions of this subchapter: (1) All reasonable steps, including assistance in scheduling and completing appointments shall be taken to ensure that persons receive needed diagnosis and treatment services. This referral assistance shall include giving the family or person the names, address and telephone numbers of providers who have expressed a willingness to furnish, at little or no expense to the family, those treatment services which are not reimbursable by the Department. (2) Appointments for diagnostic and treatment services shall be completed in a reasonable period of time, normally not to exceed 60 days from the time of the health assessment. (3) The health assessment provider shall be responsible for assisting the person in completing diagnosis and treatment. Such assistance may be rendered directly by the provider or through the provider's agreements with the community child health and disability prevention program, appropriate agency or individual. (4) The first source of referral for diagnosis and treatment shall be the person's usual source of licensed or certified health care. If a referral is required and no regular source of licensed or certified health care can be identified, the provider shall provide a list of at least three appropriate sources of care, when available, without prejudice for or against any specific source or licensed profession. One of the referral sources may be the health assessment provider. State reimbursement for diagnostic and treatment services provided to Medi-Cal beneficiaries can be made only to providers who have been approved for participation in the Medi-Cal program. (5) The community child health and disability prevention program shall: (A) Identify those persons eligible for CHDP services who can obtain needed medical or remedial services through a grantee under Title V of the Social Security Act (Maternal and Child Health and Crippled Children's Services). (B) Ensure that persons eligible for Title V services are informed of available services, and referred, if they desire, to Title V grantees that offer services appropriate to the persons' needs. (6) The source of health care selected by the person shall be indicated on the CHDP assessment form. If that source is other than the assessment provider, a copy of the CHDP referral form or equivalent shall be provided, with the person's written permission, to the identified source of healthcare. (b) Additional to (a), above, the following shall apply to Medi-Cal beneficiaries for whom diagnosis and treatment is indicated as a result of initial or periodic health assessments: (1) Medi-Cal beneficiaries, who requested assistance with transportation or scheduling the appointment for the health assessment, shall be offered assistance with transportation and scheduling appointments for diagnosis and treatment. The response to this offer shall be recorded, and this assistance shall be provided if requested by the beneficiary. (2) Medi-Cal beneficiaries, who did not request assistance with transportation or scheduling the appointment for the health assessment, may request assistance with transportation and scheduling appointments for diagnosis and treatment. If the beneficiary requests such assistance, the request shall be documented and the assistance shall be provided. (3) Treatment needed as a result of an initial health assessment shall normally be initiated within 120 days from either the date the beneficiary requested the health assessment, or the date the beneficiary was certified eligible to receive Medi-Cal benefits, whichever occurs later. Treatment needed as a result of a periodic health assessment shall normally be initiated within 120 days from either the date the beneficiary requested the health assessment, or the last day of the month in which the beneficiary's age exceeds the oldest allowable age for the health assessment according to the periodicity schedule specified in Section 6847, whichever occurs earlier. (4) If diagnostic and treatment services are not provided to a Medi-Cal beneficiary who requests such services and who also requests assistance with transportation or scheduling appointments for such services, documentation must exist showing that the family or recipient declined the services, lost eligibility, could not be located despite a good faith effort to do so, or the recipient's failure to receive the services was due to an action or decision by the family or recipient, rather than a failure by the community child health and disability prevention program to meet requirements of this subchapter, including the requirement to offer and provide assistance with transportation and scheduling appointments for services. (c) Each community child health and disability prevention program shall be responsible for developing and maintaining a referral and follow-up system for diagnosis and treatment, and for ensuring that referral is carried out. The referral and follow-up system shall be specified in the community's child health and disability prevention program plan. Agreements between the community program and providers, and between the community program and other appropriate individuals and agencies participating in the community program, may be part of the referral and follow-up system. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2, 323.7 and 324, Health and Safety Code. s 6852. Diagnosis and Treatment. (a) To be eligible for state reimbursement, diagnostic and treatment services, which may be required by Medi-Cal beneficiaries as a result of a health assessment received, shall be provided by providers approved for participation in the California Medical Assistance Program. The diagnostic and treatment services shall be in accordance with the provisions of the California Administrative Code, Title 22, Division 3 and subject to any applicable Medi-Cal program limitations. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 323, Health and Safety Code. s 6860. Conditions of Participation. (a) Dental diagnostic and treatment services shall be provided by or under the supervision of a dentist licensed to practice dentistry in California. To be eligible for state reimbursement, billing for dental services shall be in accordance with the regulations governing the California Medical Assistance Program. (b) Health assessments shall be performed in accordance with the provisions of this subchapter as follows: (1) By, or under the supervision and/or responsibility of, a physician licensed to practice medicine in California. (2) By a certified family nurse practitioner or certified pediatric nurse practitioner, as defined in Title 22, Section 51170.3(b) and (c), respectively. (c) Each individual, partnership, clinic, group, association, institution, or public or private agency desiring to participate in a community child health and disability prevention program as a provider of health assessments only, or as a provider of comprehensive health care, shall notify the director of that program of such intent. Notification shall be made to the director of each community child health and disability prevention program in which it is desired to provide service. Notification shall be in the manner established by the community program director. (d) Physicians, medical clinics, medical groups, certified pediatric nurse practitioners or certified family nurse practitioners may be approved for participation as providers in the community program by the community program director on receipt by the director of written notification stating the following: (1) The physician, certified pediatric nurse practitioner, certified family nurse practitioner, medical clinic, or medical group understands the requirements of the Child Health and Disability Prevention Program, and desires to participate in it as either a comprehensive care provider or as a provider of health assessments only. (2) If parts of the required health assessment are not available through the physician, certified pediatric nurse practitioner or certified family nurse practitioner, the physician or certified family nurse practitioner or certified pediatric nurse practitioner shall refer the person to other providers approved by the community program for completion of those parts. (e) Agencies and organizations (other than physicians and physician groups) desiring to participate in the community program, where physicians or other persons under physician supervision will be employed to do parts of the health assessment, shall state in writing the qualifications of the screening personnel when notifying the community program director of their intent to participate as providers. Participation of such agencies and organizations shall require the written approval of the community program director, and compliance with the provisions of this subchapter and with any standards that may be established by the community program director. (f) If the community child health and disability prevention program director determines that a provider, previously approved for participation in the community program, is not providing services in accordance with provisions of this subchapter or the standards established by the community program, the community program director may withdraw the approval. (g) Prepaid health plans, their subcontractors or sub-subcontractors, under contract to the Department to provide medical care to Medi-Cal enrollees are exempted from the provisions of this section only for CHDP services that are provided to their Medi-Cal enrollees. If such a prepaid health plan wishes to provide CHDP services to persons other than their Medi-Cal enrollees, full compliance with this section is required. (h) Health assessments may be conducted in public and private school facilities provided that, with respect to private school facilities, no services provided thereon pursuant to this subchapter and financed by public funds shall result in any material benefit to, or be conducted in a manner which furthers any educational or other mission of, such a school or any person or entity maintaining the school. (i) Health assessments shall be made available to eligible persons as defined in this subchapter without regard to race, religion, sex, national origin, citizenship, marital status, parenthood or source of payment. (j) Clinical laboratories, may be approved for participation as providers in the community program by the community program director on receipt by the director of written notification stating that the clinical laboratory understands the requirements of the Child Health and Disability Prevention Program, and desires to participate in it as a provider of laboratory services. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 321(c), Health and Safety Code; Sections 655.6, 2834, 2835, 2835.5 and 2836, Business and Professions Code; Section 14132.41, Welfare and Institutions Code; and 42 U.S.C. Section 1396d(a). s 6862. Types of Providers. (a) A health assessment provider shall be a physician, physician group, certified family nurse practitioner, certified pediatric nurse practitioner, or public or private agency or organization that provides the services specified in this subchapter to persons eligible to receive those services. (b) A provider may agree to provide health assessments only, or may agree to be a comprehensive care provider, that is, to provide health assessments and diagnosis and follow-up services. (c) A health assessment-only provider shall meet the following conditions unless failure to meet any of them is due to circumstances other than the provider's inaction: (1) Assure completion of the full range of health assessment services appropriate to the individual as defined in section 6846, including anti-tobacco use education and the completion of immunizations and immunization series which could not be given during the health assessment, but which are necessary to make the immunization status current. (2) Provide referral for diagnosis and treatment, as specified in section 6850, for all persons identified as needing such services as a result of health assessments. (d) A comprehensive care provider shall be certified by the Department for participation in the California Medical Assistance program and shall meet the following conditions unless failure to meet any of them is due to circumstances other than the provider's inaction: (1) Assure completion of the full range of health assessment services appropriate to the person as defined in section 6846, including anti-tobacco use education and the completion of immunizations and immunization series which could not be given during the health assessment, but which are necessary to make the immunization status current. (2) Initiate diagnosis and treatment, or referral for diagnosis and treatment, for all persons identified as needing such services as a result of the health assessment. (3) Assume overall case management of the person in the event of subsequent referrals which may be part of the needed diagnosis and treatment program. (4) Assure the provision of subsequent, periodic health assessment at the frequency indicated in section 6847. (5) Be available as a source of primary care on a continuing basis to the person in the event subsequent medical services are requested. (6) Maintain a health record for each person. (e) A clinical laboratory provider shall be a clinical laboratory that meets the definition of the Medi-Cal program in Title 22, California Code of Regulations (CCR), Section 51211.2. Note: Authority cited: Sections 208 and 321, Health and Safety Code; and Section 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections 321, 323 and 24165.3, Health and Safety Code; Sections 655.6, 2834, 2835, 2835.5 and 2836, Business and Professions Code; Section 14132.41, Welfare and Institutions Code; and 42 U.S.C. Section 1396d(a). s 6866. Procedures. (a) The health assessment provider shall inquire of all persons receiving health assessments under provisions of this subchapter as to the person's entitlement to third-party reimbursement for such services. Where such entitlement exists, it shall be billed as follows: (1) Insurance carriers shall be billed where such entitlement exists. (2) The Department's Child Health and Disability Prevention Program shall be billed, in the manner specified by the program, for health assessments provided to the following persons: (A) Medi-Cal beneficiaries if those services are not reimbursable under (1), above. (B) Persons who are not Medi-Cal beneficiaries and for whom services are not reimbursable under (1), above, but who meet the age and family income criteria specified by the Department's Child Health and Disability Prevention Program. (3) Persons enrolled in prepaid health plans that contract with the Department shall receive CHDP services from the prepaid health plan in which they are enrolled in accordance with the contract existing between the prepaid health plan and the Department. (4) Persons may be billed directly for health assessments which are not reimbursable under (1) or (2), above, or the services may be provided at no cost to the person if the provider chooses. (b) Eligibility for state-subvened health assessments shall be determined by the screening provider prior to the provision of such services. (c) Each provider who bills the Department's Child Health and Disability Prevention Program for health assessments rendered pursuant to the provisions of this subchapter shall accept as total reimbursement for those services the amount reimbursed by the Department, and shall make no additional charges to any individual or to the Department's Child Health and Disability Prevention Program for such services. (d) Providers' reimbursement claims for health assessments rendered under the provisions of this subchapter shall be subject to audit by the State anytime within three years beginning with the year in which the claim was filed. (e) A clinical laboratory may bill the Department's Child Health and Disability Prevention Program for cytologic examinations of gynecologic slides taken during the course of a CHDP health assessment, or other laboratory services resulting from a CHDP health assessment as follows: (1)The clinical laboratory shall accept as total reimbursement for the services rendered the amount reimbursed by the Department, and shall make no additional charge to any individual, provider, or to the Department's Child Health and Disability Prevention Program. (2) Each claim for reimbursement must be accompanied by a legible copy of the CHDP health assessment provider's claim form, the Confidential Screening/Billing Report (PM 160) (revision 10/91), which indicates the name, address, and CHDP provider number of the clinical laboratory that will bill the CHDP program for the examination of gynecologic slides or other laboratory services. (3) Clinical laboratories claims for reimbursement will not be processed for payment without the cross-reference information required in (2) above. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 323.2 (a), Health and Safety Code. s 6868. Schedule of Maximum Allowances. (a) Health screening procedures. Reimbursement for the procedures listed in this subsection, when billed in accordance with this subchapter, shall be the amount billed by the provider for the procedures performed, up to the maximum allowances specified in this subsection. For purposes of this subsection: new patient means a person who has not previously received a health assessment from the examiner, and there is no health assessment record for the person established with the provider; extended visit means a visit in which the patient requires as much or more time to be given a health assessment as does a new patient; routine visit means a visit in which the patient requires less time than ordinarily needed with a new patient or an extended visit. MAXIMUM HEALTH SCREENING PROCEDURE ALLOWANCE History and Physical Examination by Comprehensive Care Provider New Patient or Extended Visit Adolescent (age 12 through 20 years).... $49.51 Late childhood (age 5 through 11 years)..... 43.32 Early childhood (age 1 through 4 years)...... 40.84 Infant (birth through 11 months).... 38.37 Routine Visit Adolescent (age 12 through 20 years).... 39.60 Late childhood (age 5 through 11 years)..... 33.43 Early childhood (age 1 through 4 years)...... 30.95 Infant (birth through 11 months).... 28.46 By Health Assessment -Only Provider New Patient or Extended Visit Adolescent (age 12 through 20 years).... 43.32 Late childhood (age 5 through 11 years)..... 37.13 Early childhood (age 1 through 4 years)...... 34.65 Infant (birth through 11 months).... 32.18 Routine Visit Adolescent (age 12 through 20 years).... 37.13 Late childhood (age 5 through 11 years)..... 30.95 Early childhood (age 1 through 4 years)...... 28.46 Infant (birth through 11 months).... 25.99 Pelvic Exam.......................... ............................. 10.00 Vision Screening Snellen eye test or equivalent visual acuity test Age 7 years and older............... ............................. $ 2.02 Age 3 through 6 years............... ............................. 4.00 Hearing Screening Pure Tone Audiometry................ ............................. 9.21 Tuberculin Testing Multiple Puncture................... ............................. 4.54 Mantoux (intracutaneous)............ ............................. 7.53 (b) Laboratory Tests. For laboratory tests listed in this subsection that the provider performs, reimbursement shall be either the provider's usual charge to the general public for the test or the maximum allowance specified in this subsection, whichever is less. If a laboratory test is performed by other than the screening provider, for instance by an outside laboratory, the screening provider may bill the Department's Child Health and Disability Prevention Program for the charge made to the provider by the laboratory (except for cytologic examination of a gynecologic slide as described below), plus a charge not to exceed $4.63 for the provider's collection and handling of the specimen. The total shall not exceed the maximum allowance specified in this subsection for the laboratory test. If a clinical laboratory performs a cytologic examination of a gynecologic slide taken during the course of a CHDP health assessment, or other laboratory services resulting from a CHDP health assessment, the clinical laboratory may bill the Department's Child Health and Disability Prevention Program the clinical laboratory's usual charge to the general public not to exceed the maximum allowance specified in this subsection. The health assessment provider may bill the program a charge not to exceed $4.63 for the provider's collection and handling of the specimen. The total charge from the clinical laboratory and the health assessment provider shall not exceed the maximum allowance specified in this subsection for cytologic tests. Clinical laboratory tests shall be performed in the manner and by persons and laboratories that meet the relevant standards established in the Health and Safety Code, the Business and Professions Code and Title 17 of the California Code of Regulations. MAXIMUM LABORATORY TEST ALLOWANCE Blood Tests Hematocrit......................................................... $3.01 Hemoglobin......................................................... 3.01 Sickle Cell Status (Electrophoresis)............................... 30.11 Blood Lead Screening Blood Lead Level Determination..................................... 22.45 Phenylalanine (PKU) Blood........................................... 4.54 Urine Tests Urinalysis, routine, complete...................................... 4.54 Urine "Dipstick"................................................... 2.87 Tests for Microorganisms Culture for Neisseria Gonorrhea.................................... 6.02 Cytologic Tests Papanicolaou (Pap) Smear........................................... 11.22 Ova and Parasites, direct smears, concentration and 12.39 identification.................................................... VDRL, RPR or ART.................................................... 4.56 Chlamydia Test...................................................... 19.25 (c) Immunizations. Reimbursement for the immunizations listed in this subsection, when billed in accordance with this subchapter, shall be the amount billed by the provider for the immunizations given, up to the maximum allowances specified in this subsection. However, if the provider uses vaccine supplied at no cost to the provider by the Department's Immunization Assistance Program, the maximum reimbursement for administration of the vaccine shall be the amount determined by the Department rather than the amount specified in this subsection. The maximum reimbursement rate for the professional component of administering an immunization under this subsection shall be $4.52. The maximum allowable reimbursement for the ingredient component of an immunization shall be based on prevailing market acquisition costs as determined by the Department's fiscal intermediary. IMMUNIZATION DPT (diphtheria and tetanus toxoids with pertussis vaccine) First, second, third of series; booster. Td (combined tetanus and diphtheria toxoids, adult type) Dd (combined tetanus and diphtheria toxoids, pediatric type) Hib (Haemophillus Influenza Type b) vaccine Hib (Haemophillus Influenza Type b) conjugate vaccine HibTITER Polio: IPV (inactivated trivalent poliovirus vaccine) First, second, third of series, or booster TOPV (trivalent oral polio virus vaccine) First, second, third of series; booster. Measles vaccine Rubella vaccine Mumps vaccine MR (measles, rubella) vaccine MMR (measles, mumps, rubella) vaccine MuR (mumps, rubella) vaccine HBVAC (hepatitis B vaccine) (Pre-exposure) HBIG (hepatitis B immune globulin) (Post exposure) Note: Authority cited: Sections 208 and 321, Health and Safety Code, and Sections 14105 and 14124.5, Welfare and Institutions Code. Reference: Sections 323 and 323.2 (a), Health and Safety Code; and Section 14105, Welfare and Institutions Code; Items 4260-111-001, Chapter 258, Statutes of 1984, and Statutes of 1985, Chapter 111, Items 4260-111-001 and 890; and Section 655.6, Business and Professions Code. s 6870. Records. Records shall be maintained by the community child health and disability prevention program, and those participating in it, for the purposes and in the manner specified by the Department's Child Health and Disability Prevention Program. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 321.2 (c) and 321.2 (h), Health and Safety Code. s 6872. Reporting. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Sections 320, et seq., Health and Safety Code. s 6874. Confidentiality. (a) All information and results of the health assessments of each person shall be confidential and shall not be released without the informed consent of the person or parent or guardian. (b) The results of the health assessment shall not be released to any public or private agency, even with the consent of the person or parent or guardian, unless accompanied by a professional interpretation of what the results mean. Note: Authority cited: Sections 208 and 321, Health and Safety Code. Reference: Section 324.5, Health and Safety Code. s 6901. Definitions. (a) "Decoy" means a 15 or 16 year old individual participating in an inspection carried out by the Department to determine compliance with California law prohibiting the sale of a tobacco product to a minor. (b) "Department" means the Department of Health Services or a local law enforcement agency that has entered into an enforcement delegation contract with the Department of Health Services. (c) "Inspection" means a law enforcement activity conducted by the Department in which a decoy, under the direct supervision of a regularly employed peace officer, attempts to purchase a tobacco product at a retail site. (d) "Minor" means any individual under 18 years of age. (e) "Person" means any individual, partnership, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within the state, and any representative agent, or agency of any of the foregoing. (f) "Retail site" means any outlet that provides tobacco products for sale to consumers including, but not limited to, an establishment, vending machine, vehicle, mobile unit, stationary mobile unit, booth, stand, or concession. (g) "Sale" means the transfer or exchange for consideration or otherwise furnishing of a tobacco product to a consumer for the purpose of consumption or use, and not for re-sale. (h) "Seller" means the owner of any retail business or any employee of the retail business authorized to make sales of tobacco products to consumers. (i) "Tobacco product" means any substance containing tobacco leaf, including, but not limited to, cigarettes, cigars, pipe tobacco, snuff, chewing tobacco, or dipping tobacco. (j) "Valid identification" means a document issued by a federal, state, county, or municipal government, or subdivision or agency thereof, including, but not limited to, a motor vehicle operator's license or an identification card issued to a member of the Armed Forces, which contains the name, date of birth, description, and photograph of the individual. (k) "Vending machine" means any mechanical device, the operation of which depends upon the insertion of money, trade checks, tokens or other things representative of value and which dispenses or vends tobacco products. Note: Authority cited: Sections 22952(b) and 22952(d), Business and Professions Code; and Section 208, Health and Safety Code. Reference: Sections 22951, 22952(b), 22952(c), 22952(d)(1)-(7), 22954, 22956, 22957 and 22958 Business and Professions Code. s 6902. Warning Sign; Identification. (a) At each retail site that sells or furnishes tobacco products a sign shall be conspicuously posted so that it is likely to be read by a consumer during a sale at each cash register, vending machine or any other point at which sales occur. The sign shall meet the following specifications: (1) Contain the following words with initial letters capitalized in the following manner: The Sale of Tobacco Products to Persons Under 18 Years of Age Is Prohibited by Law and Subject to Penalties. Valid Identification May Be Required. To Report an Unlawful Tobacco Sale Call 1-800-5ASK-4-ID. Business and Professions Code Section 22952. (2) Be square in shape and no smaller than 5.5 inches high by 5.5 inches wide (30.25 square inches) or be rectangular in shape and no smaller than 3.66 inches high by 8.5 inches wide (31.11 square inches). A sign may be larger; however, the sign shall be proportionate to one set of the dimensions set forth in this subdivision. (3) Be printed in ink that is of high contrast from the color of the background material. (Examples are black ink on white paper or dark blue ink on yellow paper.) (4) Located at least one-third inch from the top and sides, the following required words shall be no smaller than 20 point medium or bold Helvetica or Futura type face: "The Sale of Tobacco Products to Persons Under 18 Years of Age Is Prohibited by Law and Subject to Penalties. Valid Identification May Be Required." Located at least one-third inch from the sides, the following required words shall be no smaller than 30 point medium or bold Helvetica or Futura type face and in all cases 6 point size larger than all other text: "To Report an Unlawful Tobacco Sale Call 1-800-5ASK-4-ID." Located at least one-quarter inch from the sides and bottom, the required legal citation "Business and Professions Code Section 22952" shall be no smaller than 12 point medium or bold Helvetica or Futura type face. (b) The seller shall request valid identification from any individual who attempts to purchase a tobacco product if that individual reasonably appears to the seller to be under 18 years of age. Note: Authority cited: Section 22952(b), Business and Professions Code. Reference: Sections 22952(b) and 22956, Business and Professions Code. s 6903. Inspections; Decoys. (a) The Department shall conduct inspections using decoys who shall present the appearance of an individual under 18 years of age. For purposes of verifying that a decoy appears to be under 18 years of age at the time of the inspection, a photograph or video recording of the decoy shall be taken prior to and on the same day as the inspection and shall be retained by the Department. (b) A decoy, if requested, shall present valid identification. (c) A decoy shall be supervised by a regularly employed peace officer at all times during the inspection. (d) Within 2 working days of a sale of tobacco to a decoy during an inspection, the peace officer who originally accompanied and supervised the decoy during the inspection, shall return to the retail site, advise the seller of the inspection and violation, and identify the decoy to the seller by means of a photograph taken the same day as the inspection. (e) The Department may use video recording equipment, including video, audio, photographic and other audio/visual recording equipment, to record and document an inspection. (f) Inspections of retail sites may be conducted: (1) on the basis of random selection in a given geographic area; or (2) in response to reports of violations of Penal Code section 308 subsection (a) or of Business and Professions Code section 22958; or (3) in response to reports of unlawful sales over the toll-free telephone number authorized by subdivision (b) of section 22952 of the Business and Professions Code. Note: Authority cited: Section 22952(d), Business and Professions Code. Reference: Sections 22952(b), 22952(c), 22952(d)(1)-(7) and 22958, Business and Professions Code; and Section 308, Penal Code. s 6904. Defenses. Failure to comply with the procedures set forth in Subdivision (d) of Section 22952 of the Business and Professions Code and Title 17, California Code of Regulations, Section 6903 shall be a defense to any action brought pursuant to the STAKE Act (Division 8.5 of the Business and Professions Code). Note: Authority cited: Section 22952(d), Business and Professions Code. Reference: Sections 22952(d)(1)-(8), Business and Professions Code. s 6905. Annual Report of Tobacco Retail Sites. (a) Each cigarette or tobacco products distributor or wholesaler and each cigarette vending machine operator as required in Business and Professions Code section 22954 shall, within 45 days after the end of the calendar year, annually file a report listing the retail sites, including dealers as defined in Revenue and Taxation Code section 30012, to which it provided tobacco products during the calendar year just ended. This report of retail sites shall be filed with the Department of Health Services, Tobacco Control Section, 601 North 7th Street, M.S. 555, P.O. Box 942732, Sacramento, CA 94234-7320. The first report shall be submitted for the calendar year beginning January 1, 1995. The annual report shall contain the following: (1) The name of the cigarette or tobacco products distributor or wholesaler or cigarette vending machine operator company. (2) The address and telephone number of the company's principal executive office. (3) The name, title, and address of the representative of the company to whom correspondence regarding this report should be addressed. (4) The name, title and signature of the official authorized to sign the report on behalf of the company. (5) A certification made pursuant to Code of Civil Procedure Section 2015.5 by the authorized person whose signature appears on the report as follows: "I certify under penalty of perjury under the laws of the State of California that the information contained in the report is true and correct: ___________ " (Date) (Signature) (6) A list of each retail site's name and the physical location of the retail site to which the company supplied tobacco products or vending machines for the preceding calendar year. The list shall include, on separate lines, the full name, street address, city and zip code of each retail site. For those companies with computer capability, the list of the retail sites is also required to be submitted on a computer diskette as a flat ASCII file, or other format to be specified by the Department of Health Services, on one or more 3 1/2 inch or 5 1/4 inch floppy diskette(s). For those companies without computer capability, submission of the list on a computer diskette is not required. For the second and subsequent year that the company files this report, the company is required to either submit the information required by this subsection or report only changes to the first report. Where a company opts in the second or subsequent year to report only changes to the first or previous report, such second or subsequent report shall include and clearly identify name or address changes of the retail sites, additional retail sites to which it supplies tobacco products or vending machines and retail sites to which it no longer supplies tobacco products or a vending machine. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 22954, Business and Professions Code; Section 30012, Revenue and Taxation Code; and Section 2015.5, Code of Civil Procedure. <<(Chapter Originally Printed 8-15-45)>> Note: Authority cited: Section 4026, Health and Safety Code. Reference: Sections 4010 -4037, Health and Safety Code. Note: Authority cited: Sections 208 and 4010.1(h), Health and Safety Code. Reference: Sections 4010.1(h), 4012, 4013, and 4019, Health and Safety Code. s 7100. Purpose. Note: Authority cited: Sections 208 and 4074, Health and Safety Code. Reference: Section 4082, Health and Safety Code. s 7101. Definition. Note: Authority cited: Sections 208 and 4074, Health and Safety Code. Reference: Section 4082, Health and Safety Code. s 7103. Employment of Certified Operator. Note: Authority cited: Sections 208 and 4074, Health and Safety Code. Reference: Section 4082, Health and Safety Code. s 7104. Operator-in-Training. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875, 106885 and 106910, Health and Safety Code. s 7105. Remote Area. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106885, Health and Safety Code. s 7106. Certification Requirements. Note: Authority cited: Sections 208 and 4074, Health and Safety Code. Reference: Section 4082, Health and Safety Code. s 7107. Grade of Operator. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875-106885, Health and Safety Code. s 7109. Requirements for Certification. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875-106885, Health and Safety Code. s 7110. Application. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106885, Health and Safety Code. s 7110.1. Processing an Application for Certification. Note: Authority cited: Section 15376, Government Code; and Section 100275, Health and Safety Code. Reference: Section 15376, Government Code; and Section 106885, Health and Safety Code. s 7110.2. Processing Time. Note: Authority cited: Section 15376, Government Code; and Section 100275, Health and Safety Code. Reference: Section 15376, Government Code; and Section 106885, Health and Safety Code. s 7111. Application Review. Note: Authority cited: Sections 208 and 4074, Health and Safety Code, Reference: Section 4082, Health and Safety Code. s 7112. Notification to Applicants. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875-106885, Health and Safety Code. s 7113. Certification Without Examination for Certain Persons Employed Prior to April 30, 1973. Note: Authority cited: Section 208 and 4074 Health and Safety Code, Reference: Sections 4082, Health and Safety Code. s 7114. Minimum Qualifications for Examination. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106910, Health and Safety Code. s 7116. Regular Certification. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875-106885, Health and Safety Code. s 7117. Temporary Certification. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875-106885, Health and Safety Code. s 7118. Limited Certification. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875-106885, Health and Safety Code. s 7120. Issuance and Renewal. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875-106885, Health and Safety Code. s 7121. Suspension for Failure to Renew Certificate. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875 and 106890, Health and Safety Code. s 7122. Revocation of Certificate. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 106875-106885, Health and Safety Code. s 7123. Posting of Certificate. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106885, Health and Safety Code. s 7125. Frequency of Examinations. Note: Authority cited: Section 208 and 4074, Health and Safety Code Reference: Section 4082, Health and Safety Code. s 7126. Examination Content. Note: Authority cited: Section 208 and 4074, Health and Safety Code Reference: Section 4082, Health and Safety Code. s 7127. Examination Procedure. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106880, Health and Safety Code. s 7130. Application Fee. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106890, Health and Safety Code. s 7131. Renewal Fee. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106890, Health and Safety Code. s 7132. Reexamination Fee. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106890, Health and Safety Code. s 7133. Penalty Fee. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106890, Health and Safety Code. s 7134. Duplicate Certificate Fee. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Section 106890, Health and Safety Code. s 7557. Drain Wells. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 208, Health and Safety Code. s 7583. Definitions. In addition to the definitions in Section 4010.1 of the Health and Safety Code, the following terms are defined for the purpose of this Chapter: (a) "Approved Water Supply" is a water supply whose potability is regulated by a State of local health agency. (b) "Auxiliary Water Supply" is any water supply other than that received from a public water system. (c) "Air-gap Separation (AG)" is a physical break between the supply line and a receiving vessel. (d) "AWWA Standard" is an official standard developed and approved by the American Water Works Association (AWWA). (e) "Cross-Connection" is an unprotected actual or potential connection between a potable water system used to supply water for drinking purposes and any source or system containing unapproved water or a substance that is not or cannot be approved as safe, wholesome, and potable. By-pass arrangements, jumper connections, removable sections, swivel or changeover devices, or other devices through which backflow could occur, shall be considered to be cross-connections. (f) "Double Check Valve Assembly (DC)" is an assembly of at least two independently acting check valves including tightly closing shut-off valves on each side of the check valve assembly and test cocks available for testing the watertightness of each check valve. (g) "Health Agency" means the California Department of Health Services, or the local health officer with respect to a small water system. (h) "Local Health Agency" means the county or city health authority. (i) "Reclaimed Water" is a wastewater which as a result of treatment is suitable for uses other than potable use. (j) "Reduced Pressure Principle Backflow Prevention Device (RP)" is a backflow preventer incorporating not less than two check valves, an automatically operated differential relief valve located between the two check valves, a tightly closing shut-off valve on each side of the check valve assembly, and equipped with necessary test cocks for testing. (k) "User Connection" is the point of connection of a user's piping to the water supplier's facilities. (l) "Water Supplier" is the person who owns or operates the public water system. (m) "Water User" is any person obtaining water from a public water supply. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7583. Purpose. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s 7584. Responsibility and Scope of Program. The water supplier shall protect the public water supply from contamination by implementation of a cross-connection control program. The program, or any portion thereof, may be implemented directly by the water supplier or by means of a contract with the local health agency, or with another agency approved by the health agency. The water supplier's cross-connection control program shall for the purpose of addressing the requirements of Sections 7585 through 7605 include, but not be limited to, the following elements: (a) The adoption of operating rules or ordinances to implement the cross-connection program. (b) The conducting of surveys to identify water user premises where cross-connections are likely to occur, (c) The provisions of backflow protection by the water user at the user's connection or within the user's premises or both, (d) The provision of at least one person trained in cross-connection control to carry out the cross-connection program, (e) The establishment of a procedure or system for testing backflow preventers, and (f) The maintenance of records of locations, tests, and repairs of backflow preventers. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s 7585. Evaluation of Hazard. The water supplier shall evaluate the degree of potential health hazard to the public water supply which may be created as a result of conditions existing on a user's premises. The water supplier, however, shall not be responsible for abatement of cross-connections which may exist within a user's premises. As a minimum, the evaluation should consider: the existence of cross-connections, the nature of materials handled on the property, the probability of a backflow occurring, the degree of piping system complexity and the potential for piping system modification. Special consideration shall be given to the premises of the following types of water users: (a) Premises where substances harmful to health are handled under pressure in a manner which could permit their entry into the public water system. This includes chemical or biological process waters and water from public water supplies which have deteriorated in sanitary quality. (b) Premises having an auxiliary water supply, unless the auxiliary supply is accepted as an additional source by the water supplier and is approved by the health agency. (c) Premises that have internal cross-connections that are not abated to the satisfaction of the water supplier or the health agency (d) Premises where cross-connections are likely to occur and entry is restricted so that cross-connection inspections cannot be made with sufficient frequency or at sufficiently short notice to assure that cross-connections do not exist. (e) Premises having a repeated history of cross-connections being established or re-established. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s 7586. User Supervisor. The health agency and water supplier may, at their discretion, require an industrial water user to designate a user supervisor when the water user's premises has a multipiping system that convey various types of fluids, some of which may be hazardous and where changes in the piping system are frequently made. The user supervisor shall be responsible for the avoidance of cross-connections during the installation, operation and maintenance of the water user's pipelines and equipment. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7588. Cross-Connection. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7589. Approved Water Supply. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7590. Auxiliary Supply. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7591. Approved Check Valve. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7592. Approved Double Check Valve Assembly. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7593. Air-Gap Separation. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7594. Approved Reduced Pressure Principle Backflow Prevention Device. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s 7601. Approval of Backflow Preventers. Backflow preventers required by this Chapter shall have passed laboratory and field evaluation tests performed by a recognized testing organization which has demonstrated their competency to perform such tests to the Department. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s 7602. Construction of Backflow Preventers. (a) Air-gap Separation. An Air-gap separation (AG) shall be at least double the diameter of the supply pipe, measured vertically from the flood rim of the receiving vessel to the supply pipe; however, in no case shall this separation be less than one inch. (b) Double Check Valve Assembly. A required double check valve assembly (DC) shall, as a minimum, conform to the AWWA Standard C506-78 (R83) adopted on January 28, 1978 for Double Check Valve Type Backflow Preventive Devices which is herein incorporated by reference. (c) Reduced Pressure Principle Backflow Prevention Device. A required reduced pressure principle backflow prevention device (RP) shall, as a minimum, conform to the AWWA Standard C506-78 (R83) adopted on January 28, 1978 for Reduced Pressure Principle Type Backflow Prevention Devices which is herein incorporated by reference. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s 7603. Location of Backflow Preventers. (a) Air-gap Separation. An air-gap separation shall be located as close as practical to the user's connection and all piping between the user's connection and the receiving tank shall be entirely visible unless otherwise approved in writing by the water supplier and the health agency. (b) Double Check Valve Assembly. A double check valve assembly shall be located as close as practical to the user's connection and shall be installed above grade, if possible, and in a manner where it is readily accessible for testing and maintenance. (c) Reduced Pressure Principle Backflow Prevention Device. A reduced pressure principle backflow prevention device shall be located as close as practical to the user's connection and shall be installed a minimum of twelve inches (12 ") above grade and not more than thirty-six inches (36 ") above grade measured from the bottom of the device and with a minimum of twelve inches (12 ") side clearance. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s 7604. Type of Protection Required. The type of protection that shall be provided to prevent backflow into the public water supply shall be commensurate with the degree of hazard that exists on the consumer's premises. The type of protective device that may be required (listed in an increasing level of protection) includes: Double Check Valve Assembly-(DC), Reduced Pressure Principle Backflow Prevention Device-(RP), and an Air-gap Separation-(AG). The water user may choose a higher level of protection than required by the water supplier. The minimum types of backflow protection required to protect the public water supply, at the water user's connection to premises with various degrees of hazard are given in Table 1. Situations which are not covered in Table 1 shall be evaluated on a case-by-case basis and the appropriate backflow protection shall be determined by the water supplier or health agency. TABLE 1 TYPE OF BACKFLOW PROTECTION REQUIRED Minimum Type of Backflow Degree of Hazard Prevention (a) Sewage and Hazardous Substances (1) Premises where there are waste water pumping and/or AG treatment plants and there is no interconnection with the potable water system. This does not include a single-family residence that has a sewage lift pump. A RP may be provided in lieu of an AG if approved by the health agency and water supplier. (2) Premises where hazardous substances are handled in any manner AG in which the substances may enter the potable water system. This does not include a single-family residence that has a sewage lift pump. A RP may be provided in lieu of an AG if approved by the health agency and water supplier. (3) Premises where there are irrigation systems into which RP fertilizers, herbicides, or pesticides are, or can be, injected. (b) Auxiliary Water Supplies (1) Premises where there is an unapproved auxiliary water supply AG which is interconnected with the public water system. A RP or DC may be provided in lieu of an AG if approved by the health agency and water supplier. (2) Premises where there is an unapproved auxiliary water supply RP and there are no interconnections with the public water system. A DC may be provided in lieu of a RP if approved by the health agency and water supplier. (c) Recycled Water (1) Premises where the public water system is used to AG supplement the recycled water supply. (2) Premises where recycled water is used, other than as allowed in RP paragraph (3), and there is no interconnection with the potable water system. (3) Residences using recycled water for landscape irrigation as DC part of an approved dual plumbed use area established pursuant to sections 60313 through 60316 unless the recycled water supplier obtains approval of the local public water supplier, or the Department if the water supplier is also the supplier of the recycled water, to utilize an alternative backflow protection plan that includes an annual inspection and annual shutdown test of the recycled water and potable water systems pursuant to subsection 60316(a). (d) Fire Protection Systems (1) Premises where the fire system is directly supplied from the DC public water system and there is an unapproved auxiliary water supply on or to the premises (not interconnected). (2) Premises where the fire system is supplied from the public AG water system and interconnected with an unapproved auxiliary water supply. A RP may be provided in lieu of an AG if approved by the health agency and water supplier. (3) Premises where the fire system is supplied from the public DC water system and where either elevated storage tanks or fire pumps which take suction from private reservoirs or tanks are used. (4) Buildings where the fire system is supplied from the public DC water system and where recycled water is used in a separate piping system within the same building. (e) Dockside Watering Points and Marine Facilities (1) Pier hydrants for supplying water to vessels for any purpose. RP (2) Premises where there are marine facilities. RP (f) Premises where entry is restricted so that inspections for RP cross-connections cannot be made with sufficient frequency or at sufficiently short notice to assure that they do not exist. (g) Premises where there is a repeated history of cross-connections RP being established or re-established. Note: Authority cited: Section 116375, Health and Safety Code; and Section 13521, Water Code. Reference: Section 116375, Health and Safety Code; and Sections 13520, 13521 and 13554(a)(3), Water Code. s 7605. Testing and Maintenance of Backflow Preventers. (a) The water supplier shall assure that adequate maintenance and periodic testing are provided by the water user to ensure their proper operation. (b) Backflow preventers shall be tested by persons who have demonstrated their competency in testing of these devices to the water supplier or health agency. (c) Backflow preventers shall be tested at least annually or more frequently if determined to be necessary by the health agency or water supplier. When devices are found to be defective, they shall be repaired or replaced in accordance with the provisions of this Chapter. (d) Backflow preventers shall be tested immediately after they are installed, relocated or repaired and not placed in service unless they are functioning as required. (e) The water supplier shall notify the water user when testing of backflow preventers is needed. The notice shall contain the date when the test must be completed. (f) Reports of testing and maintenance shall be maintained by the water supplier for a minimum of three years. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7603. Where Protection Is Required. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7604. Type of Protection. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7615. Separate Drinking Water Systems. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7616. Fire System. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 208, Health and Safety Code. s T17-7617. Process Waters. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 208, Health and Safety Code. s T17-7618. Sewage Treatment Plants and Pumping Stations. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 208, Health and Safety Code. s T17-7619. Plumbing Connections. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7620. Pier and Dock Hydrants. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7621. Marking Safe and Unsafe Water Lines. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s T17-7622. Water Supervisor. Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Reference: Section 4026, Health and Safety Code. s 7623. Intent of Regulations. Note: Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code. s 7624. Application of Regulations. Note: Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code. s 7625. Definitions. (a) "Domestic water supply reservoir" as used herein means a reservoir used to impound or store water intended solely or primarily for domestic purposes. (b) "Distribution reservoir" as used herein means a reservoir, directly connected with the distribution system of the domestic water supply project, used primarily to care for fluctuations in demand which occur over short periods of from several hours to several days, or as local storage in case of emergency such as a break in a main supply line or failure of pumping plant. Note: Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4050, 4051, 4463 and 4470.1, Health and Safety Code. s 7626. Application for Permit. (a) Recreational use on and around a domestic water supply reservoir is prohibited unless specifically authorized in a water supply permit. (b) Within 30 calendar days of receipt of an application for a permit or petition for permit modification pursuant to Section 4011 or 4019, Health and Safety Code, the Department shall inform the applicant in writing that it is either complete and accepted for filing or that it is deficient and what specific information or documentation is required to complete the application. An application is considered complete if it is in compliance with the requirements of Section 4012, Health and Safety Code. For proposed water system improvements, new water systems or a "project" as defined in Section 15378, Title 14, California Administrative Code where environmental documentation is required, a copy of such documentation shall be included in the application. (c) Within 90 calendar days from the date of filing of a completed application, the Department shall inform the applicant in writing of its decision regarding an application. (d) The Department's time periods for processing an application from the receipt of the initial application to the final decision regarding issuance or denial of a water permit based on the Department's actual performance during the two years preceding the proposal of this section, were as follows: (1) The median time was -7.5 months (2) The minimum time was -1.5 months (3) The maximum time was -85.5 months Note: Authority cited: Sections 208, 4011, 4012, 4019 and 4051, Health and Safety Code; and Section 15376, Government Code. Reference: Sections 4012, 4019, 4050, 4051, 4463 and 4470.1, Health and Safety Code; Section 15376, Government Code; and Sections 21000-21176, Public Resources Code. s 7627. Data to Accompany Application. (a) The application for a permit to allow recreational use shall be accompanied by detailed information, including but not limited to, the following: (1) Maps showing the reservoir area, including location of water works facilities, area to be open for recreational use and location of sanitary facilities to be provided for the public. (2) Data on the size of the reservoir, length of time of water storage in the reservoir, topography of the reservoir site, prevalence of wind-induced currents and other factors that may affect the quality of the stored water and movement of possible contaminants to the water intake. (3) Data on the size of the protective zone to be provided between the area of recreational use and point of water withdrawal for the water supply. (4) A statement describing the type of recreational use proposed and the maximum number of persons, cars, vehicles and boats allowed in the area. (5) A description of the water supplier's program, personnel and financing to control the recreational use, including maintenance and operations of recreational and sanitary facilities, and supervision of the people permitted in the area. Note: Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012, 4019, 4050, 4051, 4463 and 4470.1, Health and Safety Code. s 7628. Guides to Evaluating Application. Note: Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code. s 7629. Reservoirs for Which Permits May Be Granted. When the department finds that the intended recreational use will not render the water supply as delivered to the consumers impure, unwholesome or unpotable, permit for such use will be issued. Subject to the department findings the following types of domestic water supply reservoirs may be used for recreational purposes: (1) Reservoirs from which water is continuously and reliably treated by filtration and chlorination; provided that for smaller water systems, under special circumstances satisfactory to the State Department of Public Health, approved dual chlorination may be acceptable; (2) Reservoirs from which water is withdrawn by open channels or other conduits and subsequently stored again in reservoirs falling in the category of Section 7629(1) before reaching a distribution reservoir, or before entering the distribution system or a consumer's premises. s 7630. Kinds of Recreational Use Allowed or Prohibited. All regulations in this group with section numbers preceded by T17- contain building standards which appear in the California Administrative Code, Title 24, Part 6, Division T17 and, to the extent that they are building standards, are included here for convenience and continuity. Note: Authority cited: Sections 208 and 4051, Health and Safety Code. Reference: Sections 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code. Note: Authority cited: Sections 208 and 4025, Health and Safety Code. Reference: Sections 4010-4035, Health and Safety Code. Introduction s 7706. Shellfish Bed Certificate Issuable by the State Board of Public Health. Any person, firm, or corporation engaged in the cultivating or harvesting of oysters, clams, or mussels for sale to the public for human consumption shall possess a valid certificate issued by the State Board of Public Health. Note: Authority cited: Section 208, Health and Safety Code. s 7707. Shellfish Plant Certificate Issuable by the State Board of Public Health. Any person, firm, or corporation operating a plant engaged in culling, shucking, packing or repacking fresh oysters, clams or mussels for sale to the public for human consumption shall hold a valid certificate issued by the State Board of Public Health. s 7708. Authority of State Board of Public Health to Revoke or Suspend Certificate. Each certificate so issued shall be revocable or subject to suspension by the State Board of Public Health if for any reason the safety of the shellfish as an article of food is not assured or if the standards set forth herewith are not maintained at all times. s 7709. Expiration and Renewal of Certificates. A certificate issued under these regulations shall be valid for a period not to exceed one year and shall expire on February 15th of each year. An application for renewal of a certificate shall be made by January 1st of each year if an applicant desires to continue to hold a certificate. No certificate can be transferred. s 7710. Definition. For purpose of these regulations, the term "shellfish" is hereby declared to mean and include all varieties of oysters, clams, and mussels. s 7711. Types of Certificates. Shellfish certificates issued hereunder shall be of the following classifications: A. Shellfish beds and shellfish stock derived therefrom for human consumption. B. Shellfish culling, shucking, packing, and repacking plants and shucked shellfish produced therefrom for human consumption. C. A "limited" certificate may be granted as provided under Section 7744. s 7712. Application for Certificate. The applicant for a certificate to operate in either of the classifications described above shall file with the State Department of Public Health a written request accompanied by a detailed description of the shellfish beds or shellfish handling plants and a map showing the location of the beds or facilities. With the application shall be filed a description of the proposed source or sources of shell or shucked stock. He shall also file with the State Department of Public Health an agreement to comply with each and all of these regulations. s 7713. No Shellfish Grown in the State of California to Be Sold or Distributed Unless Certified. No shellfish grown in the State of California shall be sold or distributed except from growing areas that have been approved and have been granted a valid certificate by the State Board of Public Health under these regulations. Shellfish shall not be sold or distributed from growing areas in other states unless each lot of shellfish obtained therefrom bears a certificate number designating a certificate of cleanliness and safety issued by the State Department of Health of the state in which the shipment originates acceptable to the California State Department of Public Health. s 7714. No Shucked Shellfish to Be Sold or Distributed Unless Certified. No shucked shellfish shall be sold or distributed except where such shellfish have been handled in plants for which a certificate has been issued by the State Board of Public Health under these regulations. Shucked shellfish from other states shall not be sold or distributed unless each lot of shucked shellfish obtained therefrom bears a certificate number designating a certificate of cleanliness and safety issued by the State Department of Health of the state in which the shipment originates acceptable to the California State Department of Public Health. s 7719. Safety of Shellfish for Human Consumption. No shellfish shall be sold or distributed for human consumption unless it is safe as an article of food and is free from filth. s 7720. Persons Infected With Communicable Diseases. Persons who are infected with or are carriers of organisms of typhoid fever, dysentery, septic sore throat, or certain other communicable diseases which might be transmitted through shellfish or who have infected wounds or open lesions on exposed portions of the body shall not be employed in the growing beds or shucking, packing, or repacking plant. If the owner or manager has reason to suspect that any employee has contracted such a communicable disease, he shall immediately exclude said employee from the growing beds or plant. s 7725. Record of Operations. A daily record of shellfish received and shipped shall be kept showing kinds of shellfish, designation of the beds from which derived, name of grower, name of shipper, and name of consignee. These records shall be available for inspection by the State Department of Public Health or its agents during all reasonable hours. Upon request these records shall be submitted to the State Department of Public Health. s 7730. Cleanliness of Shellfish Growing Areas. Shellfish beds shall be located in growing areas not adversely affected by sewage, other wastes, or human and recreational activity. All operation of the beds shall be such as not to adversely affect the cleanliness of the growing area. s 7731. Boat Sanitation. All boats, scows, and appurtenances thereto used in the taking of shellfish or used in the transportation of shellfish from the beds to plants or used in the water over the shellfish beds shall be kept in such a state of cleanliness and repair that shellfish growing on the bed and handled and stored thereon shall not be subject to contamination. Decks, holds, or bins used for storage and/or transporting of shellfish on boats shall not be washed with polluted water. Persons in boats over the shellfish beds shall not discharge human wastes to the waters. Adequate facilities shall be provided for disposal of human wastes from persons working on the shellfish beds. s 7732. Shellfish from Uncertified Areas Brought into Certified Beds. Shellfish growing in uncertified areas may not be brought into a bed for which a certificate has been issued unless special approval is first granted by the State Department of Public Health. Such approval shall be in writing and granted only on condition that the method of transplanting and timing of arrival of the shellfish will insure that the transplanted shellfish remain in the approved growing area at least 30 days before harvesting for sale for human consumption. This translating area must be in separate portions of the bed and one in which no other shellfish are held. s 7733. Water Quality. Shell stock shall not be cleaned, stored, floated, or conditioned in water, the standard of which is not as rigid as that required at certified shellfish beds. s T17-7738. Culling Plants. Culling plants shall be located in areas free from insanitary conditions and faulty sewage disposal. They shall be provided with an ample supply of water under adequate pressure from a source approved by the State Department of Public Health for the purpose of hosing down floor and benches and cleaning the shellfish. Floors and premises shall be kept in a clean and sanitary condition. s 7739. Storage. Shellstock in storage shall be adequately protected from contamination at all times. Dry shellstock shall not be stored on floors. Storage areas must be kept clean at all times. Containers shall be clean and in good condition. s 7740. Cleanliness of Shellstock. Only shellstock that is reasonably clean and reasonably free of mud shall be shipped or marketed. Oysters, clams, or mussels which are dead or do not have tight shells shall not be shipped or marketed. s 7741. Shipping. Shellstock shall be handled and shipped under such temperature as will keep them alive. Each lot of shellstock shall be shipped in clean containers such as bags, boxes, or barrels so as to prevent spoilage or contamination during shipping. Each lot shall be plainly marked with the name and address of the shipper, the certificate number of the bed from which the oysters, clams, or mussels were obtained, and the date of harvest. s 7742. Shucking and Packing Plants and Equipment. Shellfish shall be shucked and packed in such a manner that they are not subject to contamination. Shellstock shall be free of mud when they are shucked. Only live shellfish shall be shucked. Shucked shellfish shall not remain on the shucking table for more than one hour unless refrigerated at .50 degrees Fahrenheit or less. s 7743. Washing. All shucked shellfish shall be properly washed and shall be free of sand, mud and other foreign material. Methods and equipment used for washing the shucked shellfish shall be adequate to accomplish this pur pose and shall be approved by the State Health Department. All water used for washing the shellfish shall meet the requirements of Section T17-7753 of these regulations. s T17-7744. Plant Arrangement. Unless shellfish are shucked directly into packing containers with no further processing, the shucking and packing processes shall be done in separate rooms. There shall be installed in the partition between the two rooms a delivery window through which the shucked stock is passed to the packing room. Provision shall be made for storing the employees' outer garments, aprons, gloves, etc., in a separate room. [FNa1] In special instances where shucking is done on a small scale for local retail sales, shucking and packing may be permitted in a single room if approved by the State Department of Public Health. This single room and all operations shall conform to all requirements of these regulations except that of separate shucking and packing rooms. "Limited" certificates shall be issued in these instances and all containers of shucked shellfish shall be clearly labeled or marked with the words "limited certificate" and the appropriate certificate number. [FNa1] Not a building standard. s 7745. Floors. The floors of all rooms in which shellfish are stored, shucked, washed, packed, or otherwise processed shall be constructed of concrete or other equally impervious material, graded to drain quickly, free from cracks or uneven surfaces that might interfere with proper cleaning or drainage, and maintained in a clean and satisfactory condition. s T17-7746. Walls and Ceilings. Walls and ceilings shall be maintained in a smooth, clean, washable, light-colored condition. They shall be impervious to moisture and shall be kept in good repair. Walls contiguous to benches shall, to a height of two feet above the bench top, be of smooth concrete, metal or equally nonabsorbent material. s T17-7747. Screening. The plant shall have all openings effectively screened with not less than 16- mesh screening, unless other effective means are provided to prevent the entrance of flies and other insects. s T17-7748. Light. Ample light to work by shall be provided in all working rooms. A light intensity of not less than 10 foot-candles shall be maintained on all working surfaces when workers are at their working positions. s T17-7749. Ventilation. Adequate ventilation shall be provided to prevent condensation on ceilings or other surfaces. s T17-7750. Toilet Facilities. Every shellfish culling, shucking, packing, or repacking plant shall be provided with clean and adequate toilet facilities conveniently located. [FNa1] No toilet room shall be used for the storage of garments, food products, containers, or equipment. Construction and maintenance of toilets shall comply with all local and state regulations. [FNa1] Not a building standard. s T17-7751. Handwashing Facilities. An adequate number of lavatories shall be provided at locations conveniently to toilet rooms and shellfish handling operations, including running hot and cold water, soap, and individual disposal towels. The use of a common towel is prohibited. All employees shall wash their hands thoroughly with running water and soap on beginning work and after each visit to the toilet. Signs to this effect shall be posted in conspicuous places in the plant and in the toilet rooms. s T17-7752. Sewers and Drains. Sewage and other liquid wastes shall be discharged into public sewers wherever possible. Where private sewage or waste disposal systems must be utilized they shall be constructed in accordance with state and local regulations pertaining thereto. Plant waste systems shall be properly trapped and vented. Waste liquids shall be disposed of in a manner that will not adversely affect the quality of the water in which shellfish are grown or stored. Waste lines from washing machines shall have suitable protection against the possibility of sewage or wastes entering these machines. s 7753. Water Supply. Shucking, packing, or repacking plants shall be provided with an ample supply of water under adequate pressure from a source approved by the State Department of Public Health. The supply shall be accessible to all parts of the plant, adequate in quantity, and of a safe sanitary quality. No cross-connections with unapproved supplies or other possible sources of contamination shall be permitted. s 7754. Benches and Stands. All benches and stands shall be of smooth concrete, metal, or other nonabsorbent material, free from cracks or crevices, and so constructed that drainage is complete and rapid. Shucking blocks shall be removable unless an integral part of the bench and shall be of solid one-piece construction. s 7755. Construction of Utensils and Equipment. All shucking pails, opening knives, blowers, skimmers, tanks, tubs, trays, measures, colanders, paddles, or other equipment or utensils which may come in contact with shucked shellfish shall be made of not readily corrodible, smooth, impervious material and shall be constructed in such a manner as to eliminate grooves, seams, and cracks where foreign particles, dirt, and slime might collect. Perforations in the skimmers, colanders, and blower trays shall be smooth to facilitate cleaning. Skimmers, ladles, and colanders of wire-mesh construction are not permitted. The top rim of every tank, tub, and tray shall be at least 30 inches above the floor. s 7756. Aprons and Finger Cots. All persons who handle shucked shellfish shall wear clean aprons and coats of washable and waterproof material. If finger cots or similar shields for protecting the palm of the hand are worn, they shall be of clean, washable and waterproof material. s 7757. Refrigeration. Unless shellfish are delivered to the consumer immediately upon completion of shucking, refrigeration facilities shall be provided capable of cooling the shucked shellfish to a temperature below 50 degrees Fahrenheit within two hours after the shellfish are shucked, and keeping them at this temperature until delivered to the consumer. If shucked shellfish are frozen, they shall be kept in a frozen condition until delivered to the consumer. The refrigerator or icebox shall have an impervious lining. The floor shall be graded to drain quickly. An accurate thermometer shall be kept in the refrigerator or icebox. Refrigerators shall be kept clean and sanitary at all times. s 7758. Ice. Ice used for the processing of shucked shellfish shall be obtained from an approved source and shall be stored and handled in a sanitary manner. No ice shall be allowed to come in contact with shucked shellfish. s 7759. Cleaning. The floors, walls, and, if necessary, ceilings in the plant shall be cleaned at the end of each day's operations and flushed with water. All equipment, utensils, benches, etc., which come in contact with shucked shellfish shall be thoroughly scoured at the end of each day's operations. The premises shall be kept clean and free of litter and rubbish. Equipment and articles not required in the processing of the shellfish shall be excluded from the plant. s 7760. Sterilization of Equipment. All utensils, equipment, or working surfaces coming in contact with shucked shellfish after being thoroughly cleansed shall be sterilized by methods approved by the State Department of Public Health. Sterilized equipment shall be protected from recontamination between usages. s 7761. Packing and Shipping. Shucked shellfish shall be packed and shipped either in single-service containers made of clean impervious materials or in properly designed, returnable containers [FNa1] which have received adequate cleansing and bactericidal treatment. All containers shall be stored in a manner that will protect them from contamination. Containers holding one gallon or more must be positively sealed or so sealed that tampering with the container can easily be detected. Each can, container, or package shall bear the name of the shipper, certificate number of the shucking, packing, or repacking plant, and date packed. The date may be in code if the code is registered with the State Department of Public Health. [FNa1] Returnable containers will be accepted only for interplant shipment of shucked shellfish. Note: Authority cited: Sections 202, 205(d) and 208, Health and Safety Code. Reference: Sections 26542; 28312-28315 and 28440, Health and Safety Code. s 7762. Repacking Shucked Stock. Repacking of shucked shellfish shall only be done if contamination of the shellfish will not occur. Repacking of shucked stock shall be in conformance with all sections of these regulations dealing with shucking and packing of shellfish. Note: Authority cited for Group 6: Sections 102 and 208, Health and Safety Code. Reference: Sections 24100 through 24109, Health and Safety Code. s 7861. General. (a) Each water bottler shall: (1) Exercise due care and diligence to protect water sources under his control; (2) Provide and effectively operate and maintain water treatment, bottling, capping, bottle washing and product storage facilities; (3) Maintain adequate water quality monitoring; (4) Take whatever investigative or corrective action is necessary to assure that a pure, wholesome and potable water is supplied to consumers. (b) Each water vending machine operator shall: (1) Operate and maintain all water vending machines under his control in a sanitary manner; (2) Maintain adequate water quality monitoring; (3) Take whatever investigative or corrective action is necessary to assure that a pure, wholesome and potable water is supplied to consumers. Note: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, inclusive, Health and Safety Code. s 7862. Definitions. (a) "Department" means the California Department of Health. (b) "Approved" means approved in writing by the Department. (c) "Bottler" means a person, firm, partnership, or corporation, or other business organization owning and/or operating a water bottling plant. (d) "Vended Water" means water dispensed by way of a water vending machine. (e) "Water-vending machine" means any self-service device which upon insertion of a coin, coins, or token, or upon receipt of payment by other means, dispenses unit servings of water in bulk into a customer's container, without the necessity of refilling the machine between each operation. (f) "Mineral Water" means bottled drinking water containing more than 500 milligrams per liter of total dissolved solids and/or one or more chemical constituents in excess of the concentrations listed in the Federal Bottled Water Quality Standards, 21 CFR, Section 103.35 (d). Note: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code. s 7863. Bottled and Vending Machine Water Quality. (a) Quality standards for bottled water withdrawn from sealed bottles, and water from vending machines at point of discharge to customer's container, shall conform to Federal Water Quality Standards for Bottled Water, 21 CFR, Section 103.35 except: (1) Mineral water shall be exempt from chemical quality standards of 21 CFR, Section 103.35 (d); (2) Bottled fluoridated water shall contain 1.0_____+ 0.1 milligrams per liter fluoride ion. Note: Authority cited: Sections 208 and 4041, Health and Safety Code. Reference: Section 4041, Health and Safety Code. s 7864. Water Bottling Plants. (a) Bottlers shall comply with the following Good Manufacturing Practices: (1) Federal standards relating to Processing and Bottling of Bottled Drinking Water, 21 CFR, Section 129. (2) Federal Standards Relating to Human Foods; Current Good Manufacturing Practice in manufacture, processing, packing or holding, 21 CFR, Section 110. (3) Regulations for Sanitation in Food Plants, 17 CAC 12235-12285. (b) Prior to bottling, bottled water shall be subject to effective treatment by ozonation, ultraviolet or other treatment approved by the Department. Note: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043 Health and Safety Code. s 7865. Water Vending Machines. (a) Products from each water vending machine shall be sampled by the vending machine operator once every six months or coliform organisms. (b) Prior to discharge to the customer's container, water vended by machine shall be subject to effective treatment by ultraviolet or other treatment approved by the Department. Note: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code. s 7866. Cleaning and Sanitizing of Containers. (a) Bottler shall utilize at least one of the following cleaning/sanitizing processes for multi-use bottles or containers: (1) Any of the federal sanitizing procedures listed in 21 CFR, Section 129.80 (d). (2) Exposing all interior surfaces to not less than two and one-half percent caustic solution at a minimum temperature of 120F for not less than one minute where high velocity jets are used or for not less than three minutes where soaker type bottle washers are used. A final rinsing of the bottle inside, using operations or product water shall be used to remove traces of any caustic sanitizing agent. (3) Any other method approved in writing by the Department. Note: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code. s 7867. Water Dispensers. (a) Dispensers for bottled water, furnished by the water bottler or distributor, shall be delivered to the consumer's premise in a clean, sanitary condition, protected from dust, dirt or other contamination. (b) Ollas or other water-holding dispensers, both refrigerated and nonrefrigerated, shall be checked for cleanliness each time the dispenser is serviced by the bottler or distributor's representative and when necessary returned to the bottler or distributor for cleaning and sanitizing before reuse. (c) Only methods and procedures approved by the Department shall be used to clean and sanitize water dispensers. Note: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code. s 7868. Labels and Advertising. (a) Mineral water shall be plainly labeled "Mineral Water," and the label shall show amounts of any mineral substance which exceed bottled water standards, 21 CFR, Section 103.35, and the source of the water. Note: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code. s 7869. Applications. Application for a license by an out-of-state bottler or by a distributor of water bottled out of state shall be submitted with sufficient information to demonstrate that the water is pure, wholesome and potable. This information shall be included in a report prepared by the agency having authority over bottled water in the state where the water is bottled. If no agency has specific authority over bottled water, the report shall be prepared by a registered civil engineer with recognized experience and competence in the field of water sanitation and/or food production. The applicant may contract with the Department for out-of-state inspections and preparation of the report necessary to support issuance of the license. The report shall include, but not be limited to, the following: (a) Where applicable, a copy of the out-of-state laws and regulations on bottled water and the license issued. (b) A report on compliance or noncompliance with all water quality and sampling and water bottling requirements specified in this chapter. (c) A statement from the out-of-state regulatory agency and the applicant that they will inform the Department of contamination or illness associated with the bottled water shipped into the State. (d) Information on type and quantity of bottled water shipped into the State and how the bottled water is packaged, transported and stored upon arrival before distribution in the State. Note: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code. s 7870. Licenses. a) Water Bottling Plants. The owners or operators of each water bottling plant shall make application for license on forms provided by the Department. The application and license fee shall be submitted for a calendar year. License fees payable are due on or before January 1 and shall be in accordance with Table 1. For new bottling operations, the fee shall be $500.00 for the first calendar year's operation. For water bottled out of state, license fees shall be in accordance with Table 1. Average weekly production shall be determined by dividing the number of gallons shipped into California during the previous year by 52. TABLE 1 WATER BOTTLING PLANT LICENSE FEE SCHEDULE Last Year's Average Current Weekly Production Annual Bottled Water (in Gallons) License Fee 2,500 or less............. $100 2,501 to 10,000........... $200 10,001 to 25,000.......... $300 25,001 to 50,000.......... $400 Over 50,000............... $500 (b) Water Vending Machines. Each water vending machine owner or operator shall make application and obtain a license for each machine operated under his control. The annual license fee for each approved machine shall be $5 per calendar year. A decal or seal provided by the Department indicating a license fee has been paid shall be affixed in a prominent place to each vending machine in service. (c) Water Vending Machine Approval. Each model of a water vending machine shall be approved by the Department. For newly designed machines or existing machines with modifications, adequate data shall be submitted regarding ability of the machine to comply with the standards of design and to continuously and reliably deliver water complying with water quality standards prescribed in Section 7863. The evaluation fee for each model of a new machine and existing machines with modifications affecting the quality of the water produced shall be in accordance with Table 2. The Department may accept, without payment of a fee, the evaluation of a new or modified model by a recognized independent laboratory. TABLE 2 WATER VENDING MACHINE EVALUATION FEE SCHEDULE New machine.................................. $500 Existing machine with major modifications.... $200 Existing machine with minor modifications.... $50 Note: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Reference: Sections 4040-4043, Health and Safety Code. s 7871. Doors and Windows. s 7872. Toilet -Handwashing Facilities. s 7873. Plant Maintenance. s 7874. Personnel -Cleanliness. s 7875. Cleaning and Sanitizing of Containers. s 7876. Filling and Closures. s 7877. Dry Storage. s 7878. Water Dispensers. s 7879. Water Vending Machines. s 7880. Records. s 7881. Labels and Signs. s 7882. Applications. s 7883. Licenses. s 7925. Sale of Rat Exterminators. The sale or exposure for sale of alleged rodent exterminators, the manufacture of which is based upon the use of cultures of bacteria which may contaminate human food supplies, is hereby prohibited. s 7933. Definitions. (a) Vector Management Unit. "Vector management unit" means the organizational entity within the Department of Health with primary responsibility for the surveillance, prevention and control of insects and other animals of public health significance. (b) Wild Rodent. "Wild rodent" means wild ground squirrels, chipmunks, rats, mice or any other members of the order Rodentia occurring in nature in California except muskrats and beavers. s 7934. Registration. (a) Each person holding a valid scientific collecting permit issued by the Department of Fish and Game pursuant to Fish and Game Code Section 2576, who captures or holds in quarantine wild rodents with the intent to sell them shall register annually with the health officer of each jurisdiction in which the wild rodents are captured or quarantined. (b) The local health officer shall notify the vector management unit, within seven days, of each person registered. Note: Authority cited for Article 2: Sections 102 and 208, Health and Safety Code. Reference: Sections 205, 3053 and 3114, Health and Safety Code. s 7935. Disinfestation, Quarantine and Shipment of Wild Rodents. (a) No person shall sell any wild rodent which has not been disinfected of ectoparasites and quarantined pursuant to the provisions of this Section. (b) Disinfestation of rodents shall be as follows: (1) Any person capturing wild rodents with the intent to sell shall, in the locality of capture, disinfest each rodent of ectoparasites using the 1977 "Specifications for disinfestation of wild rodents captured and held for sale" issued by the vector management unit. (2) Upon release from quarantine and prior to shipment, each rodent shall again be disinfected using the 1977 "Specifications for disinfestation of wild rodents captured and held for sale" issued by the vector management unit. (c) Quarantine of rodents shall be as follows: (1) The rodents shall be segregated and confined in cages by species, and date and locality of capture, with the date and specific locality of capture clearly designated on the cages. (2) The rodents shall be held in quarantine for a period of two weeks prior to the date of shipment. (3) If a rodent dies, the quarantine of all remaining rodents in that cage shall be extended two weeks from the date of that death or any later death. (4) Each rodent death shall be reported to the local health officer within two working days of the rodent's death. (5) Rodent carcasses shall be promptly frozen pending collection by the local health officer. (d) Shipment of rodents shall be as follows: (1) A statement shall accompany the shipment and shall bear the names and addresses of the shipper and receiver, the date of shipment, the location and dates of capture, and certification that the rodents have been quarantined and disinfested of ectoparasites. (2) Such statement shall be retained by the receiver for a period of one year. (3) On the date of shipment, the shipper shall submit two copies of the shipment statement to the local health officer, who shall forward, within seven days, one copy to the vector management unit. s 7936. Reports. The local health officer shall report all deaths of wild rodents held in quarantine to the vector management unit and ship the carcasses of such rodents to the State laboratory for examination as directed by the vector management unit. s 7937. Disposition of Trapped Wild Rodents. All wild rodents trapped in the same general area within which a rodent or other animal has been found to be infected with plague or other disease communicable to man shall be subjected to such quarantine, isolation, disinfestation or other procedure which the vector management unit finds necessary for the protection of the public health. s 7941.1. Internship Program. An internship program shall include field training equivalent to 600 hours of supervised field experience or completion of six months of supervised field experience in a local environmental health jurisdiction during the formal undergraduate or graduate course studies for the degree in environmental health and shall include experience in at least six environmental program areas. Three of the areas of field experience shall be selected from the following six basic environmental program areas: food protection, waste management (liquid, solid, and hazardous), water sanitation, housing and institutions, recreational swimming areas and waters, and vector control. Experience in the three remaining environmental program areas shall be selected from the following: air sanitation, safety and accident prevention, land development and use, disaster sanitation, electromagnetic radiation, milk and dairy products sanitation, noise control, occupational health, rabies and animal disease control, and any of those from the six basic program areas above not previously selected. Note: Authority cited: Section 520, Health and Safety Code. Reference: Section 520, Health and Safety Code. s 7941.2. Approved Educational Institution. In order to be approved by the Department, an institution shall be on the list of accredited colleges or universities maintained by the U.S. Office of Education and shall meet the curriculum requirements specified in Section 7941.5(b) if providing course work leading to a degree in environmental health. Note: Authority cited: Section 520, Health and Safety Code. Reference: Section 520, Health and Safety Code. s 7941.3. Review of Curriculum. Institutions requesting approval of their environmental health degree program shall first submit their curriculum to the Sanitarian Registration Certification Committee for review and if it meets the prescribed curricula as specified in Section 7941.5(b) it shall be submitted to the Department for approval. Note: Authority cited: Section 520, Health and Safety Code. Reference: Section 520, Health and Safety Code. s 7941.4. Certification of Registration. Note: Authority cited: Section 520, Health and Safety Code. Reference: Section 522, Health and Safety Code. s 7941.5. Educational and Experience Requirements. Note: Authority cited: Section 520, Health and Safety Code. Reference: Section 520, Health and Safety Code. s 7941.6. Cross-Certification with Department of Food and Agriculture. Note: Authority cited: Section 520, Health and Safety Code. Reference: Section 517, Health and Safety Code. s 7942. Exceptions. Note: Authority cited: Section 542(b), Health and Safety Code. s 7943. Application Submission, Completion and Notification. Note: Authority cited: Section 208, Health and Safety Code; and Section 15376, Government Code. Reference: Section 520, Health and Safety Code; and Sections 15376 and 15378, Government Code. s 7944. Application Review Period. Note: Authority cited: Section 208, Health and Safety Code; and Section 15376, Government Code. Reference: Section 520, Health and Safety Code; and Sections 15376 and 15378, Government Code. s 7945. Application Decision Period. Note: Authority cited: Section 208, Health and Safety Code; and Section 15376, Government Code. Reference: Section 520, Health and Safety Code; and Sections 15376 and 15378, Government Code. s 7946. Median, Minimum, and Maximum Application Processing Times. Note: Authority cited: Section 208, Health and Safety Code; and Section 15376, Government Code. Reference: Section 520, Health and Safety Code; and Sections 15376 and 15378, Government Code. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Sections 24156 and 24157, Health and Safety Code. s 7952. Public Water-Contact Sports Area Defined. Public water-contact sports area means any area so designated (1) by a regional water pollution control board, or (2) by any other authorized and responsible public agency. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code. s 7953. Public Beach Defined. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code. s 7954. Safety Program Defined. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code. s 7955. Refuse Defined. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code. s 7956. Storm Drain. "Storm drain" means a conveyance through which water flows onto or adjacent to a public beach and includes rivers, creeks, and streams, whether in natural or in man-made channels. Note: Authority cited: Sections 100275, 115880 and 116075, Health and Safety Code. Reference: Sections 115880, 116075 and 116080, Health and Safety Code. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code. s 7957. Physical Standard. No sewage, sludge, grease, or other physical evidence of sewage discharge shall be visible at any time on any public beaches or water-contact sports areas. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code. s 7958. Bacteriological Standards. (a) The minimum protective bacteriological standards for waters adjacent to public beaches and public water-contact sports areas shall be as follows: (1) Based on a single sample, the density of bacteria in water from each sampling station at a public beach or public water contact sports area shall not exceed: (A) 1,000 total coliform bacteria per 100 milliliters, if the ratio of fecal/total coliform bacteria exceeds 0.1; or (B) 10,000 total coliform bacteria per 100 milliliters; or (C) 400 fecal coliform bacteria per 100 milliliters; or (D) 104 enterococcus bacteria per 100 milliliters. (2) Based on the mean of the logarithms of the results of at least five weekly samples during any 30-day sampling period, the density of bacteria in water from any sampling station at a public beach or public water contact sports area, shall not exceed: (A) 1,000 total coliform bacteria per 100 milliliters; or (B) 200 fecal coliform bacteria per 100 milliliters; or (C) 35 enterococcus bacteria per 100 milliliters. (b) Water samples shall be submitted for bacteriological analyses to a laboratory certified by the Environmental Laboratory Accreditation Program, California Department of Health Services in microbiology for methods for the analysis of the sample type. Note: Authority cited: Sections 100275, 115880 and 116075, Health and Safety Code. Reference: Sections 115880, 116075 and 116080, Health and Safety Code. s 7959. Bacteriological Sampling. (a) In order to determine that the bacteriological standards specified in 7958 above are being met in a water-contact sports area designated by a Regional Water Quality Control Board in waters affected by a waste discharge, water samples shall be collected at such sampling stations and at such frequencies as may be specified by said board in its waste discharge requirements. (b) In waters of a public beach or water-contact sports area that has not been so designated by a Regional Water Quality Control Board, water samples shall be collected at such sampling stations and at such frequencies as may be determined by the local health officer or the Department. Local health officers shall be responsible for the proper collection and analysis of water samples in such areas. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Sections 24156 and 24157, Health and Safety Code. s 7960. Corrective Action. When a public beach or public water-contact sports area fails to meet the standards as set forth in 7957 or 7958 above, the local health officer or the Department, after taking into consideration the causes therefor, may at his or its discretion close, post with warning signs, or otherwise restrict use of said public beach or public water-contact sports area until such time as corrective action has been taken and the standards as set forth in 7957 and 7958 above are met. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Sections 24156 and 24157, Health and Safety Code. s 7961. Public Beaches Visited by More Than 50,000 People Annually and Adjacent to Storm Drains. (a) Waters adjacent to a public beach shall be tested for bacteria identified in Section 7958 on at least a weekly basis from April 1 to October 31, inclusive, if the beach is (1) Visited by more than 50,000 people annually, and (2) Located adjacent to a storm drain that flows in the summer. (b) Water samples shall be taken from locations that include areas affected by storm drains. Samples shall be taken in ankle- to knee-deep water, approximately 4 to 24 inches below the water surface. (c) When testing reveals that the waters adjacent to a public beach fail to meet any of the standards set forth in Section 7958(a)(1) the local health officer shall post the beach pursuant to Health and Safety Code Section 115915, and shall use the standards of Section 7958(a)(1) and (2) in determining the necessity to restrict the use of or close the public beach or portion thereof. (d) In the event of a known release of untreated sewage into waters adjacent to a public beach, the local health officer shall: (1) Immediately post and close the beach or a portion thereof, or otherwise restrict its use until the source of the sewage release is eliminated; (2) Sample the affected waters; and (3) Continue closure or restriction of the beach or a portion thereof and posting the beach until testing results establish that the standards of Section 7958(a)(1) are satisfied. Note: Authority cited: Sections 100275, 115880 and 116075, Health and Safety Code. Reference: Sections 115880, 116075 and 116080, Health and Safety Code. s 7962. Duties Imposed on a Local Public Officer or Agency. Pursuant to Health and Safety Code Sections 115880(h), 115885(g), and 115915(c), any duty imposed upon a local public officer or agency by Section 7961 shall be mandatory only during a fiscal year in which the Legislature has appropriated sufficient funds, as determined by the State Director of Health Services, in the annual Budget Act or otherwise for local agencies to cover the costs to those agencies associated with performance of these duties. Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sections 115880, 115885 and 115915, Health and Safety Code. Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Reference: Section 24156, Health and Safety Code. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Sections 427.3, 427.5, 427.6 and 427.9, Health and Safety Code. s 7971. Beach. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Sections 427.3, 427.5, 427.6 and 427.9, Health and Safety Code. s 7972. Saltwater Body. Saltwater Body means the ocean, a marine bay, estuary or lagoon. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427, Health and Safety Code. s 7973. Freshwater Body. Freshwater Body means a natural or artificial lake, river, reservoir, stream or canal. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427, Health and Safety Code. s 7974. Refuse. Refuse means domestic or industrial garbage, rubbish, or other debris adversely affecting public health and safety as specified by the Health Officer. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7975. Sanitation. Sanitation means the maintenance of a safe and healthful environment by means of removal of refuse; provision of sanitary toilet and handwashing facilities; disposal of sewage and liquid wastes; protection of bathing water quality; provision of pure, wholesome and potable drinking water; and control of harmful insects, rodents and animals. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7976. Recreational Purposes. Recreational purposes include but are not limited to, swimming, camping, scenic enjoyment, fishing, shellfish gathering, surfing, scuba or snorkel diving, boating, equestrianship, use of recreational vehicles, jogging, walking, and beachcombing. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427, Health and Safety Code. s 7977. Public Health and Safety. Public health and safety means the maintenance of an environment that contributes to human well being, and in which there is an absence of human disease, ill health or injury. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7978. Health Officer. Health Officer means the legally appointed Health Officer of the county or city having jurisdiction of the area in which a public beach is located. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.5, Health and Safety Code. s 7979. Exemption. Sections 7981 through 7991 of Title 17 shall not apply when the Health Officer determines that the beach is maintained primarily as an open space. The criteria, among others, that may be evidence of open space is lack of developed access, lack of parking facilities, lack of lifeguard services, or where casual use normally does not exceed 50 people per mile of shoreline. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7980. Review by Health Officer. No persons shall begin construction, reconstruction or alteration of any public beach sanitation facility without first submitting plans, specifications and other such information, as may be required, to the Health Officer for his review and written approval. If no action is taken within fifteen (15) days of submission of plans, the project shall be deemed ap proved. If the Health Officer disapproves, the reason shall be so stated in writing . Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7981. Application. The provisions of this article shall be applicable to public beaches where overnight camping is not permitted. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7982. Toilets. Toilets shall conform to the State Plumbing Code, Part 5, Title 24, California Administrative Code. Portable toilets may be substituted for plumbed toilets. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Sections 427.3, Health and Safety Code. s 7983. Water Supply. Water when provided for drinking, showers, or handwashing shall be from a source approved by the Health Officer. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7984. Maintenance. Toilets shall be available to the public at all times the beach is officially open for use. All facilities must be maintained in a clean and sanitary condition at all times. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7985. Refuse Handling. (a) Refuse containers approved by the Health Officer shall be provided at all public beaches. (b) All refuse shall be stored in the container in a manner which will not create a nuisance. (c) Containers shall be emptied at frequencies sufficient to prevent overflow and to be maintained in a sanitary condition. (d) Every public beach shall be maintained in a clean condition free of refuse. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7985.1. Animals. No person shall bring onto or allow any animal, except guide dogs used by the blind, to remain on any beach which has been designated a public swimming beach by the state, or any city, county, or city and county and where lifeguards are provided, except that horses may be ridden on designated equestrian trails and areas. This regulation is not intended to prohibit or supersede any local ordinance now in effect or which may be enacted. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7986. Implementation. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7987. Application. The provisions of this article shall be applicable to public beaches used for overnight camping. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7988. Refuse Handling. (a) Refuse containers approved by the Health Officer shall be provided in every camping area. (b) All refuse shall be stored and removed in a manner that will not create a nuisance. (c) Beach areas and areas set aside for camping shall, at all times, be maintained in a clean and safe condition. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7988.1. Animals. No person shall bring onto or allow any animal, except guide dogs used by the blind, to remain on any beach which has been designated a public swimming beach by the state, or any city, county, or city and county and where lifeguards are provided, except that horses may be ridden on designated equestrian trails and areas. This regulation is not intended to prohibit or supersede any local ordinance now in effect or which may be enacted. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7989. Campsites. (a) No travel trailer, camp car, recreational vehicle or tent shall be located closer than six feet from any building or other travel trailer, camp car, recreational vehicle or tent on an adjacent lot or campsite. (b) Each vehicular lot or campsite in a camping area shall have direct access. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7990. Sanitary Facilities. (a) Toilets shall conform to the State Plumbing Code, Part 5, Title 24, California Administrative Code. (b) Shower baths or other bathing facilities are not required; however, when provided, they shall conform to the State Plumbing Code, Part 5, Title 24, California Administrative Code. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7991. Maintenance. All sanitary facilities shall be maintained in a clean and safe condition. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7992. Disposal of Sewage Wastes. (a) Wastewater or material from plumbing fixtures shall not be permitted to be deposited upon the ground. (b) Campsites not provided with a drain inlet shall not be occupied by a travel trailer, camp car, or recreational vehicle equipped with plumbing unless the drain outlet of the vehicle is capped or as otherwise provided by part (c) of this section. Each campsite for use by vehicles equipped with toilets, unless self-contained shall be provided with a three-inch drain inlet. (c) Other means of disposing of liquid wastes, not including human wastes, may be approved by the Health Officer. (d) Trailer sanitation stations approved by the Health Officer and designed to receive the discharge of sewage holding tanks of self-contained vehicles shall be installed or available in an accessible location to every public beach campground area in which there are campsites not provided with drain inlets designed to receive the discharge of sewage wastes. Trailer sanitation stations shall be provided on the basis of one station for each 100 such campsites or portion thereof. (e) Trailer sanitation stations shall be designed and constructed as required by Sections 5570 through 5580, Title 25, California Administrative Code. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7993. Laundry Facilities. Laundry facilities are not required; however, when provided they shall conform to the State Plumbing Code, Part 5, Title 24, California Administrative Code. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s 7994. Water Supply. When provided, potable water shall be from a source approved by the Health Officer and obtainable from faucets installed not more than 400 feet from each campsite. Potable water shall be adequate for all the requirements of the camping area. Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Reference: Section 427.3, Health and Safety Code. s T17-8000. Intent of Regulations. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.20, Health and Safety Code. s T17-8001. Food Crop. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.21, Health and Safety Code. s T17-8002. Privacy. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code. s 8003. Toilet Facilities. Toilet facilities include water flush toilets, chemical toilets, or sanitary privies where lawful, in portable or fixed form. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.23, Health and Safety Code. s 8004. General Standards. Toilet facilities shall meet the following standards: (a) Toilet facilities shall provide a minimum area of eight (8) square feet, with a minimum width of two and one-half (2 1/2) feet for each toilet seat. A minimum area of ten (10) square feet, with a minimum width of two and one-half (2 1/2) feet, shall be required when a urinal is included. Sufficient additional space shall be included if handwashing facilities are within the facility. (b) Units housing toilet and handwashing facilities shall be rigidly constructed and their inside surfaces shall be of nonabsorbent material, smooth, readily cleanable, and finished in a light color. (c) Units housing toilet and handwashing facilities shall be ventilated and provided with self-closing doors, lockable from the inside. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code. s 8005. Chemical Toilet Standards. The wastewater tank on chemical toilets shall be constructed of durable, easily cleanable material and have a minimum tank capacity of forty gallons. Construction shall be such as to prevent splashing on the occupant, field, or road. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Sections 5474.23 and 547.29, Health and Safety Code. s 8006. Suitable Chemicals. Odor control and solid liquefying chemicals that are effective at all times shall be used in chemical toilet waste holding tanks. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.29, Health and Safety Code. s 8007. Disposal of Contents of Chemical Tanks. Contents of chemical tanks shall be disposed of by draining or pumping into a sanitary sewer, an approved septic tank of sufficient capacity to handle the wastes, a suitably sized and constructed holding tank, approved by the local health department, or by any other method approved by the local health department. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code. s 8008. Standards. Handwashing facilities shall meet the following standards: (a) Pure, wholesome, and potable water shall be available for handwashing. (b) Signs shall be posted, indicating that the water is only for handwashing purposes. (c) The water tank shall provide a minimum capacity of fifteen gallons. (d) Handwashing facilities shall be provided at the unit or in the immediate vicinity. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.26, Health and Safety Code. s 8009. Privies. Privies shall be moved to a new site or taken out of service when the pit is filled to within two feet of the adjacent ground surface. The pit contents shall be covered with at least two feet of well-compacted dirt when the privy is moved. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code. s 8010. Toilets. It shall be the responsibility of the employer to insure that toilets are serviced and maintained in a clean, sanitary condition and kept in good repair at all times. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code. s 8011. Toilet Paperholder. Toilet paper shall be provided in a suitable holder in each toilet unit. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code. s 8012. Standards. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.26, Health and Safety Code. s 8013. Water Flush Toilets and Handwashing Facilities. Water flush toilets and handwashing facilities shall conform to the (Compiled) State Building Standards Code, Part 5, Title 24, California Administrative Code. Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Reference: Section 5474.25, Health and Safety Code. s 8025. Intent. Note: Authority cited for Group 12: Section 102, Health and Safety Code. Reference: Section 13521, Water Code. <<(Subchapter Originally Printed 7-21-73)>> Note: Authority cited: Section 208, Health and Safety Code, and Section 21082, Public Resources Code. Reference: Section 21000 et seq., Public Resources Code. s 10101. Order Promulgating Regulations. Under the authority of Sections 200 through 208, 26321, 26542, 28013, 28153, 28182, 28243, 28339, 28440, 28508, 28663.5 and 28709 of the Health and Safety Code, and Section 1147 of the Agricultural Code, the following regulations for the enforcement of Division 21 of the Health and Safety Code are hereby promulgated. These regulations shall take effect on September 1, 1954. The regulations now in force are hereby repealed as of the date the new regulations herein promulgated shall become effective. Note: Authority cited for subchapter 2 filed 7-29-54: Sections 200 through 208, 26321, 26542, 28013, 28153, 28182, 28243, 28339, 28440, 28508, 28663.5, 28709, Health and Safety Code, and Section 1147, Agricultural Code. s 10102. General Regulations. s 10103. Constitutionality. If any section, subsection, clause, sentence, or phrase of these regulations or standards is for any reason held to be invalid or unconstitutional, such decision shall not affect the remaining portions of these regulations or standards. The State Board of Public Health hereby declares that it would have adopted the remaining portions of these regulations or standards irrespective of the fact, that any such section, subsection, clause, sentence, or phrase of these regulations or standards be declared invalid or unconstitutional. s 10150. Cosmetic Regulations. DRUGS AND DEVICES s 10200. Dietary Supplement. (a) "Dietary supplement" (1) Means an article (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) A vitamin, (B) A mineral, (C) An herb or other botanical, (D) An amino acid, (E) A dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or (F) A concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E); (2) Means a product that (A) Is labeled as a dietary supplement and (B) Is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or if not intended for ingestion in such a form (C) Is not represented for use as a conventional food, or as a sole item of a meal or the diet; and (3) Does (A) Include an article that is approved as a new drug in compliance with Health and Safety Code section 111550, subdivision (a) or (b), certified as an antibiotic under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. section 357, and/or licensed as a biologic under the Public Health and Safety Act, 42 U.S.C. section 262 and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food, unless the article, when used as or in a dietary supplement under the conditions of use set forth in the labeling for such dietary supplement is adulterated under California Health and Safety Code section 110545, and (B) Not include 1. An article that is approved as a new drug in compliance with Health and Safety Code section 111550, subdivision (a) or (b), certified as an antibiotic under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. section 357, and/or licensed as a biologic under the Public Health and Safety Act, 42 U.S.C., section 262, or 2. An article authorized for investigation as a new drug, antibiotic, or biologic for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, and which was not, before its approval, certification, licensing, or authorization, marketed as a dietary supplement. (b) A dietary supplement may be a food or a drug, or both a food and a drug, as these terms are defined in Health and Safety code sections 109935 and 109925. Note: Authority cited: Sections 100275, 110065 and 110100, Health and Safety Code. Reference: Sections 110175, 110290, 110545, 110620, 110625, 110630, 110660, 110705, 110760, 110765 and 110770, Health and Safety Code. s 10350. Labeling Defined (26207). s 10355. Truth of Labeling (26208). s 10360. New Drugs -Definition. Newness of a drug may arise by reason (among other reasons) of: (a) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component; (b) The newness for drug use of a combination of two or more substances, none of which is a new drug; (c) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug; (d) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body; or (e) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26021, Health and Safety Code. s 10365. Drugs -Name (26230). s 10370. Poisonous Insecticides and Rodenticides, Use of (26234(2)). s 10371. Drugs: Current Good Manufacturing Practice in Manufacture, Processing, Packaging, Labeling or Holding (26234(3)). Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 26234(3), Health and Safety Code. s 10375. Blending of Certified Coal Tar Colors (26235 (2)). s 10376. Drug and Device Manufacturing Licenses. (a) The fee for a manufacturer's license as required by Sections 26685 and 26688 of the Health and Safety Code is $200.00 and will cover a period of 12 months. The license is not transferable and will not be prorated. (b) Manufacturers of human prescription drugs shall pay an additional license fee of $100.00 per year, plus the fingerprint processing fee charged by the California Department of Justice. (c) Application for Drug Manufacturing License shall be made on State Department of Health form #EH-52 (Rev. 4/93). Applications for a Device Manufacturing License shall be made on State Department of Health form #EH-72. (d) Applications for a Drug Manufacturing License shall include the following information on or attached to the application form: (1) The name of the license applicant, and the full business address and telephone number of the manufacturing facility; (2) All trade or business names used by the license applicant; (3) Name(s) of the person(s) in charge of manufacturing; (4) Name, address and telephone number of the person responsible for correspondence; (5) The type of ownership or operation (for example, partnership, association, corporation, or individual/sole proprietorship); (6) The name(s) of the owner and/or operator of the license applicant, including: (A) If an individual, the name of the individual; if a sole proprietorship, the name of the sole proprietor and the name of the business entity; (B) If a partnership or other unincorporated association, the name of each partner or member, and name of the partnership or association; (C) If a corporation, the corporate name, and the state of incorporation, the name and title of each corporate officer and director; and (D) The name of each person holding more than 5 percent equity, or debt liability of the applicant. (7) Types of products to be manufactured; (8) Type of processing to be utilized; (9) Signature of license applicant under penalty of perjury affirming that the information in the application is true and accurate; (10) Printed name and title of the individual signing the application; (11) Date application was signed; and (12) For human prescription drug manufacturers only: (A) properly completed Disclosure Statement (form #EH-53 (rev. 4/93)), two properly completed fingerprint cards, and fingerprint processing fee for each person in charge of manufacturing and each person whose name is required to be included in the license application under Paragraphs (d)(6)(A) through (d)(6)(C). However, where the license applicant is a corporation, partnership, or other business association and the total number of partners, members, or corporate officers, directors, and shareholders (as the case may be) exceeds five, the application shall so state, and the documents and fee described in this Paragraph shall only be submitted for each person in charge of manufacturing, and 1. For corporations: of the corporate officers who reside in California, or who reside outside California, but are involved in the routine operations of the manufacturing facility, the documents and fee shall be submitted for each of the five highest ranking officers in this group, and 2. For partnerships, joint ventures, and similar business association: of the partners or members who reside in California, or who reside outside California, but are involved in the routine operations of the manufacturing facility, the documents and fee shall be submitted for each of the five persons in this group who own the largest interests in the applicant entity. (B) Fingerprint cards and fingerprint processing fee shall only be submitted once for each person. If there is a change of any person in charge of manufacturing or any person occupying a position listed in Paragraphs (d)(6)(A) through (d)(6)(C), fingerprint cards and processing fee shall be submitted for each new or additional person. (C) Other persons listed in Paragraph (d)(6) may be required by the Department to submit the documents described in this Paragraph as necessary to determine the qualifications of the applicant. (e) Within 30 calendar days of receipt of a drug manufacturing license application, the Department shall inform the applicant in writing that it is either complete and accepted for filing or that the application is deficient and what specific information or documentation is required to complete the application. An application is considered complete when all information, documents, and fees required in this Section have been received by the Department. (f) Within 240 calendar days from the date of filing of a completed drug manufacturing license application, the Department shall inform the applicant in writing of its decision regarding a drug manufacturing license application. The median time for the Department to process a drug manufacturing license application from acceptance of the initial application to the final license decision has been 29 calendar days; the minimum time was one calendar day; the maximum time was 919 calendar days. Note: Authority cited: Section 15376, Government Code and Sections 102, 208, 26202, 26209 and 26688, Health and Safety Code. Reference: Sections 26685, 26687, 26688 and 26689, Health and Safety Code. s 10377. Definitions. (a) The definitions set forth in this Section apply to Sections 10376 through 10377.8 only. (b) Blood means whole blood collected from a single donor and processed either for transfusion or further manufacturing. (c) Blood component means that part of blood separated by physical or mechanical means. (d) Controlled Substance means, unless otherwise specified, a drug, substance, or immediate precursor which is listed in any schedule in Health and Safety Code Sections 11054, 11055, 11056, 11057, or 11058, or which is regulated as a controlled substance under the Controlled Substances Act (21 U.S.C. s 801 et seq.) or the Controlled Substances Import and Export Act (21 U.S.C. s 951 et seq.). (e) Drug sample means a unit of a human prescription drug that is not intended to be sold and is intended to promote the sale of the drug. (f) Human prescription drug means any drug intended for human use required by State law to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 26660 of the Health and Safety Code. (g) Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure of any function of the body of man, including those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (h) Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the drug product. (i) Manufacturer means any person who prepares, compounds, propagates, processes, or fabricates any drug. The term manufacturer includes anyone who repackages or otherwise changes the container, wrapper, or labeling of any drug in furtherance of the distribution of the drug. The term manufacturer does not include: (1) A retailer who repackages from a bulk container at the time of sale to its ultimate consumer; or (2) Anyone who sells, purchases, or trades blood or blood components intended for transfusion, provided that the blood or blood components are prepared using physical or mechanical means, not chemical processes. (j) Transfusion means a use of blood or blood components in which the blood or blood components are administered into a vein of a human being for treatment of disease, including physical injury. Note: Authority cited: Sections 102, 208 and 26202, Health and Safety Code. Reference: Sections 26209, 26685, 26686 and 26688, Health and Safety Code. s 10377.1. Qualifications. (a) A license to manufacture human prescription drugs may be denied on the ground that the license applicant is not qualified by reason of the applicant's experience to manufacture and distribute human prescription drugs in a safe manner and in compliance with federal, state, and local drug laws. In the case of a partnership, association, or corporation, an applicant's experience includes the experience of each person whose name is required to be included in the license application. An applicant's experience includes, but is not limited to, the following factors: (1) Any conviction of the applicant under any federal, state, or local laws relating to drugs, including drug samples, wholesale or retail drug distribution, or distribution of controlled substances; (2) Any felony conviction of the applicant under federal, state, or local laws which is substantially or rationally related to the qualifications, functions, and duties of a licensed human prescription drug manufacturer; a crime shall be considered substantially or rationally related to qualifications, functions, or duties of human prescription drug manufacturer if, reasonably or to a substantial degree, it evidences present or potential unfitness of a licensee to perform the functions authorized by the license in a manner consistent with the public health, safety, or welfare. (3) The applicant's past experience in the manufacture or distribution of drugs, including controlled substances; (4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution; (5) Suspension or revocation by federal, state, or local government of any license or permit currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances; (6) Compliance with licensing requirements under drug or device licenses previously granted by the Department, if any; (7) Compliance with requirements to maintain and/or make available to the Department those records required under the Sherman Food, Drug, and Cosmetic Law (Health and Saf. Code s 26000 et seq.) and the regulations adopted pursuant to that law; (8) Compliance with requirements to make available to federal, state, or local law enforcement officials those records described in 21 Code of Federal Regulations section 205.50 (55 Fed. Reg. 38025-38026 (Sept. 14, 1990)); and (9) History of addiction or habitual use of any controlled substance, narcotic, prescription drug, or alcoholic beverage. (b) As used in subsection (a), "conviction" includes a plea, verdict, or finding of guilt regardless of whether sentence has been imposed, but does not include: (1) any conviction for an offense specified in subdivision (a) or (b) of Health and Safety Code Section 11361.5 which became final more than two years prior to the date of the license application, or (2) any conviction under Health and Safety Code Section 11557 or its successor Section 11366 when that conviction was stipulated or designated to be a lesser included offense of the offense of possession of marijuana; (c) The Department may deny a license to a license applicant if it determines that the granting of such a license would not be in the public interest, based on factors which are substantially or rationally related to protecting the public from adulterated or misbranded human prescription drugs. Note: Authority cited: Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612, 26689 and 26691, Health and Safety Code. s 10377.2. Revocation and Suspension. (a) Any conviction of any violation of federal, state, or local drug laws shall be grounds for suspending or revoking a license to manufacture human prescription drugs. (b) Any action or conduct which would have warranted denial of a license to manufacture human prescription drugs shall be grounds for suspending or revoking a license to manufacture human prescription drugs. Note: Authority cited: Sections 102, 208 and 26202, Health and Safety Code. Reference: Sections 26688, 26689, 26691 and 26801, Health and Safety Code. s 10377.3. Compliance. Human prescription drug manufacturers and their officers, agents, representatives, and employees shall comply with the requirements of Sections 10377.4, 10377.5, 10377.6, 10377.7, and 10377.8 relating to human prescription drugs. Note: Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code. s 10377.4. Requirements for the Storage and Handling of Human Prescription Drugs. (a) All facilities at which human prescription manufacturers manufacture, store, warehouse, handle, offer, market, display, or otherwise hold human prescription drugs shall be secure from unauthorized entry and shall have adequate security conditions, as follows: (1) Access from outside the premises shall be kept to a minimum and be well-controlled; (2) The outside perimeter of the premises shall be well-lighted; and (3) Entry into areas where human prescription drugs are held shall be limited to authorized personnel. (b) All such facilities shall be equipped with an alarm system to detect entry after hours. (c) All such facilities shall be equipped with an alarm system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records. (d) Each outgoing shipment of human prescription drugs shall be carefully inspected for identity of the human prescription drugs and to ensure that there is no delivery of human prescription drugs that have been damaged in storage or held under improper conditions. Records of nonconforming drugs and their disposition shall be established and maintained, and shall include the name and label potency of the drug product, dosage form, lot number, quantity, reason for nonconformance, name of the inspector, date of inspection, and disposition. (e) Human prescription drugs manufactured by the licensee, which are outdated, damaged, deteriorated, misbranded, or adulterated, shall be quarantined and physically separated from other prescription drugs until they are destroyed or brought into compliance with all applicable laws by reprocessing or relabeling. Records of drugs quarantined shall be established and maintained, and shall include the name and label potency of the quarantined drug product, dosage form, lot number, reason for the quarantine, name of the person responsible for the quarantine, location of quarantined drug product, date of disposition, and ultimate disposition of the quarantined drug product. Note: Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code. s 10377.5. Requirements for the Establishment and Maintenance of Human Prescription Drug Records. (a) Human prescription drug manufacturers shall establish and maintain inventories and records of all transactions regarding the disposal of human prescription drugs. These records shall include the following information: (1) The identity and quantity of the human prescription drugs disposed of; and (2) The dates of disposal of the human prescription drugs. (b) Inventories and records of receipt, distribution, disposal, and other disposition of human prescription drugs, including records described in Section 10377.4(d) and (e), shall be made available for inspection and photocopying by the Department or any authorized federal, state, or local law enforcement agency officials for a period of at least three years following distribution, disposal, or other disposition. (c) Inventories and records of receipt, distribution, disposal, and other disposition of human prescription drugs, including records described in Section 10377.4(d) and (e), that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection as soon as possible, but no later than two working days after a request by an authorized official of a federal, state, or local law enforcement agency. (d) Human prescription drug manufacturers shall establish and maintain lists of officers, directors, managers, and other persons in charge of human prescription drug manufacturing, distribution, storage, and handling, including a description of their duties and a summary of their qualifications. Note: Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code. s 10377.6. Written Policies and Procedures for the Handling of Human Prescription Drugs. (a) Human prescription drug manufacturers shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the security and disposition of human prescription drugs including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. (b) Human prescription drug manufacturers shall include in their written policies and procedures the following: (1) A procedure to be followed for handling recalls and withdrawals of human prescription drugs. This procedure shall be adequate to deal with recalls and withdrawals due to: (A) Any action initiated at the request of the Department, the federal Food and Drug Administration or other federal, state, or local law enforcement or other government agency; (B) Any voluntary action by the manufacturer to remove defective or potentially defective human prescription drugs from the market; or (C) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design; (2) A procedure to ensure that the manufacturer is prepared for, protected against, and is ready to handle any crisis that affects security or op eration of any facility in the event of fire, flood, or other natural disaster, or strike or other situations of local, state or national emergency; and (3) A procedure to ensure that any outdated human prescription drugs shall be segregated from other drugs and destroyed. This procedure shall provide for written documentation of the disposition of outdated human prescription drugs. This documentation shall be maintained for at least three years after disposition of the outdated human prescription drugs. Note: Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code. s 10377.7. Inspection by Federal, State, and Local Law Enforcement Officials. Human prescription drug manufacturers shall permit authorized federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures, during business hours or any other reasonable times and in a reasonable manner, to the extent authorized by law. Note: Authority cited: Sections 102, 208 and 26202, Health and Safety Code. Reference: Section 26689, Health and Safety Code. s 10377.8. Manufacturers of Active Ingredient Components of Human Prescription Drugs. (a) In addition to the regulations in this article, manufacturers of any active ingredient component of a human prescription drug shall comply with the following sections of Code of Federal Regulations, title 21, part 211 (revised as of April 1, 1992), except that all references to "drug product" shall apply to active ingredient components: sections 211.25 (Personnel qualifications), 211.28 (Personnel responsibilities), 211.42 (Design and construction features), 211.44 (Lighting), 211.46 (Ventilation, air filtration, air heating and cooling), 211.48(a) [first sentence] and (b) (Plumbing), 211.50 (Sewage and refuse), 211.52 (Washing and toilet facilities), 211.56 (Sanitation), 211.58(Maintenance), 211.63 (Equipment design, size, and location), 211.65 (Equipment construction), 211.67 (Equipment cleaning and maintenance), 211.68 (Automatic, mechanical, and electronic equipment), 211.142 (Warehousing procedures), 211.150 (Distribution procedures), 211.180(a), (c), (d), and (f) (General requirements), 211.182 (Equipment cleaning and use logs), 211.196 (Distribution records), 211.204 (Returned drug products), and 211.208 (Drug product salvaging). (b) In the event that it is impossible for a manufacturer of a biological drug to comply with both this section and the federal regulations for the manufacture of biologic drugs, this section shall not apply to the extent that it conflicts with a federal regulation specifically applicable to the biological drug product in question. Note: Authority cited: Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code. s 10380. Labeling, Misbranding (26240). s 10381. Label Non-Prescription Drugs. Pregnancy/Nursing. (a) Any drug not subject to Section 26660 of the Health and Safety Code which is intended for systemic absorption into the human body shall include on the label the following statement: "Caution: If pregnant or nursing a baby, consult your physician or pharmacist before using this product." (b) Section 10381(a) shall not apply if such drug: (1) Is intended for poison control purposes. (2) Is labeled with information regarding use in pregnancy and nursing which is substantially similar to the statement required by Section 10381(a). (3) Meets both of the following: (A) It is intended to benefit the embryo, fetus or nursing infant during the period of pregnancy or lactation. (B) It is labeled with specific directions for use during the period of pregnancy or lactation pursuant to federal or state requirements. (4) Is not intended to be systemically absorbed. (5) Is oxygen intended for emergency use. (c) Any drug manufactured and labeled after 11-18-82 shall be misbranded if the information required by this section is not disclosed on the label. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26400, 26630 and 26638, Health and Safety Code. s 10385. Labeling Requirements (26241). s 10386. Manufacturer of Finished Dosage Form. The intent of this section is to assure that the advertising and labeling required by Section 26636(c) of the code provides sufficient useful information to pharmacists, physicians, and other purchasers of prescription drugs that they may identify certain persons participating in the manufacturing of the finished dosage form of such drug(s). These regulations are in addition to the regulations of other sections of the Sherman Food, Drug, and Cosmetic Law regarding labeling and advertising requirements for drugs. (a) For the purpose of this section the finished dosage form of a prescription drug is defined as that form of the drug which is or is intended to be dispensed or administered to the patient and requires no further manufacturing or processing other than packaging and labeling. (b) For the purpose of this section only, the term "drug" shall include only those articles as defined in Section 26010 of the Act which achieve their principal intended purposes through chemical action within or on the body of man or other animals or which are metabolized in the achievement of these purposes. (c) For the purpose of this section the term "manufacturer" means persons who "manufacture" as that term is defined by Section 26019 of the Health and Safety Code. (d) For the purpose of this section the term advertisement shall have the same definition as Section 26002 of the Health and Safety Code. (e) The labeling and advertising for any prescription drug, including those whose label states "distributed by . . ." or similar language, must contain the name and place of business of the manufacturer who mixed the final ingredients, and the manufacturer who encapsulated (if in capsule form) or tableted (if in tablet form) the finished dosage form, qualified by such phrases as "final ingredients mixed by . . .," "encapsulated by . . .," "tableted by . . .," or words of similar or like meaning that express the facts. The presence of the name and address of only one manufacturer shall mean that only the named firm mixed the final ingredients and encapsulated (if in capsule form) or tableted (if in tablet form) the finished dosage form. (f) The requirement for declaration of the name of the manufacturer of the finished dosage form shall be deemed to be satisfied in the case of a corporation only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. The statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. (g) For the purposes of this section, all products subject to this section will be deemed to be misbranded if the name and place of business of each manufacturer as described in the foregoing subsections of this regulation is not included in the labeling on, or within the package from which the drug is dispensed and in all advertising of such product intended primarily for dissemination to California practitioners. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26636, Health and Safety Code. s 10390. Forms of Making Required Statements (26242). s 10395. Statements of Ingredients and Proportions (26243). s 10400. Hoxsey Method for Treatment of Cancer. (a) The Hoxsey method is a cancer treatment system which employs the use of the substances potassium iodide, lactated pepsin, red clover blossoms, cascara sagrada, licorice, burdock root, stillingia root, berberis root, poke root, echinacea root, prickly ash bark, and buckthorn bark, either singly or in combination with each other. (b) The prescription, administration, sale or other distribution of Hoxsey agents, or any of the ingredients described in subsection (a) of this section, whether singly or in any combination, or in any dosage or guise whatever, in the diagnosis, alleviation, treatment or cure of cancer, or for treatment of any patient who has or who believes he or she has or who may have cancer is prohibited, except as provided by Section 1708 of the Health and Safety Code. (c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing any or all ingredients of the Hoxsey formula, make any representation that said Hoxsey method for the treatment of cancer, or any of the ingredients described in subsection (a) of this section, whether singly or in any combination or in any guise whatever, has any value in arresting or curing cancer. Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code. s 10400.1. Beta-Cyanogenetic Glucosides ( "Laetriles") Agent for Treatment of Cancer. (a) The Department of Public Health has carefully considered a document entitled "A Report on the Treatment of Cancer with Beta-Cyanogenetic Glucosides ('Laetriles')" dated May 20, 1963, and is satisfied beyond a reasonable doubt that the findings therein are true. The Department hereby ratifies and adopts said report as its own and a copy of same is on file with the California State Department of Public Health and is available for public inspection at its office located at 2151 Berkeley Way, Berkeley, California. (b) The Department of Public Health hereby finds that beta-cyanogenetic glucosides including amygdalin (with or without the addition of diisopropyl ammonium iodide), and prunasin, commonly known as "Laetriles," are of no value in the diagnosis, treatment, alleviation or cure of cancer and that the use of one or more of these agents in early cancer to the exclusion of conventional treatment might well be dangerous since treatment with acceptable, modern, curative methods (surgery or radiation) would thereby be delayed potentially until such time as metastases had occurred and the cancer therefore might no longer be curable. In late disease palliative effect is lacking. The Department recommends that the public refrain from using any of the said agents or any agent, drug, medicine, compound or device substantially similar thereto in the diagnosis, alleviation, treatment or cure of cancer. (c) Except as otherwise provided in Section 1708 of the California Health and Safety Code the prescription, administration, sale or other distribution of beta-cyanogenetic glucosides including amygdalin (with or without the addition of diisopropyl ammonium iodide) and prunasin, commonly known as "Laetriles" or, any substantially similar agent, drug, medicine, compound or device to any patient who has or who believes that he has or may have cancer is prohibited; and the Department shall upon learning of such prescription, administration, sale or other distribution take appropriate steps to cause such persons so doing to cease and desist therefrom. (d) No person shall for the purpose of prescribing, administering, selling or otherwise distributing beta-cyanogenetic glucosides including amygdalin (with or without the addition of diisopropyl ammonium iodide) or prunasin, commonly known as "Laetriles," make any representation that said agents have any value in arresting, alleviating or curing cancer; and the Department shall upon learning of such representation take appropriate steps to cause such person to cease and desist from such re presentation and shall take such other and further steps as may be appropriate to cause such representation to be discontinued. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 1704, Health and Safety Code. s 10400.2. Bolen Test for Diagnosis of Cancer. (a) As used in this section, the Bolen test means the determination of malignancy by the clotting patterns of a drop of blood as described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to the DIAGNOSIS OF CANCER WITH THE BOLEN TEST dated April 17, 1963. (b) Except as otherwise provided in Section 1708 of the Health and Safety Code, the administration of the Bolen test or any substantially similar test for the diagnosis of cancer in any patient who has or who believes that he or she has or who may have cancer is prohibited. (c) No person shall, for the purpose of administering the Bolen test make any representation that it has any value in diagnosing cancer. Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference, Section 1704, Health and Safety Code. s 10400.3. Koch Agents for Treatment of Cancer. (a) As used in this section, the Koch agents mean those agents described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to THE TREATMENT OF CANCER WITH THE KOCH SYNTHETIC ANTITOXINS -(Malonide, Glyoxylide and Parabenzoquinone) dated April 17, 1963, which agents are commonly known as Malonide, Glyoxylide and Parabenzoquinone and are further commonly collectively known as the Koch agents. (b) Except as otherwise provided in Section 1708 of the Health and Safety Code the prescription, administration, sale or other distribution of the three Koch agents, as defined in subsection (a) of this section, or any agents substantially similar thereto, whether singly or in any combination, or in any dosage or guise whatever, in the diagnosis, alleviation, treatment or cure of cancer, or for treatment of any patient who has or who believes that he or she has or who may have cancer is prohibited. (c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing any or all of the Koch agents, make any representation that the Koch agents, whether singly or in any combination or in any guise whatever, have any value in arresting, alleviating, or curing cancer. Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code. s 10400.4. Lincoln Staphage Lysate Agent for Treatment of Cancer. (a) As used in this section, Lincoln Staphage Lysate means that agent described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to THE TREATMENT OF CANCER WITH LINCOLN STAPHAGE LYSATE, dated April 17, 1963, which agent consists of staphylococcus bacteriophage lysates, alpha and beta is commonly known as Lincoln Staphage Lysate. (b) Except as otherwise provided in Section 1708 of the Health and Safety Code the prescription, administration, sale or other distribution of Lincoln Staphage Lysate, as defined in subsection (a) of this section, or any agent substantially similar thereto, in the diagnosis, alleviation, treatment or cure of cancer, or for the treatment of any patient who has or who believes that he or she has or who may have cancer is prohibited. (c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing Lincoln Staphage Lysate, make any representation that it has any value in arresting, alleviating or curing cancer. Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code. s 10400.5. Mucorhicin Agent for Treatment of Cancer. (a) As used in this section, Mucorhicin means that agent, consisting of a mold substrate containing generic forms of Mucor, Rhizopus and various strains of penicillium, as described and defined in the report entitled REPORT, FINDINGS, AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to THE TREATMENT OF CANCER WITH MUCORHICIN, dated April 17, 1963. (b) Except as otherwise provided in Section 1708 of the Health and Safety Code the prescription, administration, sale or other distribution of Mucorhicin, as defined in subsection (a) of this section, or any agent substantially similar thereto, in any dosage or guise whatever, in the diagnosis, alleviation, treatment or cure of cancer, or for the treatment of any patient who has or who believes that he or she has or who may have cancer is prohibited. (c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing Mucorhicin, make any representation that Mucorhicin in any dosage or in any guise whatever, has any value in arresting, alleviating or curing cancer. Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code. s 10400.6. Anthrone Test for Diagnosis of Cancer. (a) As used in this section, the Anthrone test means the determination of the presence or degree of malignancy by the purported determination of the 24 hour level of chorionic gonadotropin excretion in urine as such method is described and defined in the report entitled in part REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL with respect to the DIAGNOSIS OF CANCER WITH THE ANTHRONE TEST dated August 17, 1964. (b) Except as otherwise provided in Section 1708 of the Health and Safety Code, the use of the Anthrone test, as described in subsection (a) of this section, or any test substantially similar thereto for the diagnosis of cancer in any patient who has or who believes that he has or who may have cancer is prohibited. (c) No person shall, for the purpose of using the Anthrone test in any guise whatever, make any representation that it has any value in diagnosing cancer. Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code. s 10400.7. Krebiozen for Treatment of Cancer. (a) As used in this section Krebiozen means that agent described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS OF THE CANCER ADVISORY COUNCIL with respect to THE TREATMENT OF CANCER WITH KREBIOZEN dated May 27, 1964 and the supplementary report of said Council dated September 12, 1967. (b) Except as otherwise provided in Section 1708 of the Health and Safety Code, the prescription, administration, sale or other distribution of Krebiozen, as defined in subsection (a) of this section, or any substantially similar agent, drug, medicine, compound or device to any patient who has or who believes he or she has or who may have cancer is prohibited. (c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing Krebiozen, make any representation that said agent has any value in arresting, alleviating or curing cancer. Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code. s 10401. Drugs for Use in the Diagnosis, Treatment, Alleviation or Cure of Cancer in Human Beings. Note: Authority cited: Sections 102, 208 and 1704(a), Health and Safety Code. Reference: Sections 1707.1-1707.7, Health and Safety Code. s 10401.1. Investigation of Various Agents for the Diagnosis or Treatment of Cancer. Experts wishing to investigate the value of drugs, medicines, compounds or devices in the diagnosis or treatment of cancer under the exemption provisions of Section 1708 of the Health and Safety Code shall provide the following information, in 20 copies, to the Department for approval prior to initiating the investigation. (a) A sample of the labeling of the drug, medicine, compound or device which shall include the name, quantity, lot number of the agent and name of manufacturer and also a statement "Caution: New drug (or medicine or compound or device). Use in the diagnosis, treatment, alleviation or cure of cancer limited by law to investigational use." (b) If the animal testing required by subsection (b) of 1708 has been done by or under the auspices of a person other than the applicant and the latter wishes to use the results of such testing as a part of his request for approval of the investigation, a signed authorization for use of the results from the person or persons responsible for such testing shall be provided. (c) The written statement signed by the expert shall show what facilities the expert will use for the investigation to be conducted by him; that the drug, medicine, compound or device will be used solely by him or under his direction for the investigation; and shall contain information identifying any assistant or agent of the expert who uses the drug, medicine, compound or device under the direction of the expert. It shall also include a study plan for the investigation to show that a significant number of cases and controls are to be studied, the duration of the study and all other details of the plan; a sworn statement that the agent is to be used solely for investigational purposes without compensation or profit; and a detailed outline of the training and experience of the expert, this latter requirement being met by submission of a curriculum vitae and a list of publications. Criteria for evaluation of effect shall be those adopted by the Cancer Advisory Council on April 12, 1967. (d) A copy of the consent form required by subsection (f) of 1708. (e) An acknowledgment that complete records will be kept. Note: Authority cited: Sections 208 and 1704(a), Health and Safety Code. Reference: Sections 1707.1 through 1707.5, Health and Safety Code. s 10401.2. American Board of Oncology. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 1708.5, Health and Safety Code (Chapter 1130, Statutes of 1980). s 10405. Directions for Use -Exemptions Thereto. (a) Adequate Directions for Use. "Adequate directions for use" means directions under which a layperson can use drug or device safely and for the purposes for which it is intended. Directions for use may be inadequate because (among other reasons) of omission, in whole or in part, or incorrect specification of: (1) Statements of all conditions, purposes, or uses for which such drug or device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the drug or device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the drug or device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner. (2) Quantity of dose (including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions). (3) Frequency of administration or application. (4) Duration of administration or application. (5) Time of administration or application (in relation to time of meals, time of onset of symptoms, or other time factors). (6) Route or method of administration or application. (7) Preparation for use (shaking, dilution, adjustment of temperature, or other manipulation or process). (8) Methods of application or use. (b) Exemptions From Directions for Use. Drugs and devices subject to Section 26638 of the code, shall be exempt from the requirements under the following conditions: (1) Exemptions for Drugs and Devices Shipped Directly to Licensed Practitioners, Hospitals, Clinics, or Public Health Agencies for Professional Use. Except as provided in subparagraph (3) of paragraph (b) of this section, a drug or device shipped directly to or in the possession of a practitioner licensed by law to administer the drug or to use or direct the use of the device, or shipped directly to or in the possession of a hospital, clinic, or public health agency, for use in the course of the professional practice of such a licensed practitioner, shall be exempt from Section 26638 of the code if its meets the conditions of Section 10410 (b) and (c), Section 10415 (a) (2) and (3) or Section 10415 (b) (2) and (3) of these regulations. (2) Retail Exemption for Veterinary Drugs and Prescription Devices. A drug or device subject to Section 10410 or Section 10415 (b) of these regulations shall be exempt at the time of delivery to the ultimate purchaser or user from Section 26638 of the code if it is delivered by a licensed practitioner in the course of the practitioner's professional practice or upon a prescription or other order lawfully issued in the course of his professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order. (3) Exemption for New Drugs or Devices. A new drug or device shall be exempt from Section 26638 of the code: (A) To the extent to which such exemption is claimed in an effective application with respect to such drug or device under Section 26670 of the code; or (B) If no application under Section 26670 of the code is effective with respect to such drug but it complies with Section 26679 of the code and Section 10440 of the regulations thereunder. No exemptions shall apply to any other drug or device which would be a new drug or device if its labeling bore representation for its intended uses. (4) Exemption for Drugs or Devices When Directions Are Commonly Known. A drug or device shall be exempt from Section 26638 of the code insofar as adequate directions for common uses thereof are known to the ordinary individual. (5) Exemptions for Inactive Ingredients. A harmless drug that is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, in the preparation of other drugs shall be exempt from Section 26638 of the code. This exemption shall not apply to any substance intended for a use which results in the preparation of a new drug, unless an effective new drug application provides for such use. (6) Exemption for Diagnostic Reagents. A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product shall be exempt from Section 26638 of the code if it meets the requirements of Section 809.10 of Title 21 of the Code of Federal Regulations. (7) Exemption for Prescription Chemicals and Other Prescription Components. For use by registered pharmacists in compounding prescriptions or for dispensing in dosage unit form upon prescriptions shall be exempt from Section 26638 of the code if all the following conditions are met: (A) The drug is an official liquid acid or official liquid alkali, or is not a liquid solution, emulsion, suspension, tablet, capsule, or other dosage unit form; and (B) The label of the drug bears: 1. The statement "For prescription compounding"; and 2. If in substantially all dosage forms in which it may be dispensed it is subject to Section 26662 of the code, the statement "Caution: Federal law prohibits dispensing without prescription," or "Caution: Not to be dispensed without a prescription"; or, 3. If it is not subject to Section 26662 of the code and is by custom among retail pharmacists sold in or from the intrastate package for use by consumers, "Adequate directions for use" in the conditions for which it is so sold. Provided, however, that the information referred to in subdivision 3 of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed. (C) This exemption shall not apply to any substance intended for use in compounding which results in a new drug, unless an effective new drug application covers such use of the drug in compounding prescriptions. (8) Exemption for Processing, Repacking, or Manufacture. A drug in a bulk package (except tablets, capsules, or other dosage unit forms) or a device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from Section 26638 of the code if its label bears the statement "Caution: For manufacturing, processing, or repacking"; and, if in substantially all dosage forms in which it may be dispensed it is subject to Section 26662, the statement "Caution: Federal law prohibits dispensing without prescription," or "Caution: Not to be dispensed without a prescription." This exemption and the exemption under paragraph (7) of this section may be claimed for the same article. But the exemption shall not apply to a substance, material, or device intended for use in manufacture, processing, or repacking which causes the finished article to be a new drug, unless: (A) An effective new drug application held by the person preparing the dosage form or drug for dispensing covers the production and delivery to that person of such substance; or (B) If no application is effective with respect to such new drug, the label statement "Caution: For manufacturing, processing, or repacking" is immediately supplemented by the words "in the preparation of a new drug limited by state law to investigational use," and the delivery is made for use only in the manufacture of such new drug limited to investigational use as provided in Section 10560 of these regulations. (9) Exemption for Drugs and Devices for Use in Teaching, Research, and Analysis. A drug or device subject to Sections 10410 and 10415 (a) and (b) of these regulations shall be exempt from Section 26638 of the code if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or research not involving clinical use, or in clinical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing. (10) Expiration of Exemptions. (A) If a shipment or delivery or any part thereof, of a drug or device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such drug or device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device. (B) The exemptions conferred by paragraphs (5), (6), (7), (8), and (9) of this section shall continue until the drugs or devices are used, for the purposes for which they are exempted, or until they are relabeled to comply with Section 26638 of the code. If, however, the drug is converted, compounded, or manufactured into a dosage form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the dosage form is labeled as required by Section 26662 of the code and Sections 10410 and 10415 (a) and (b) of these regulations. (c) Intended Uses. The words "intended uses" or words of similar import in paragraphs (a) and (b) of this section refer to the objective intent of the persons legally responsible for the labeling of drugs and devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representative, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into intrastate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom the packer distributor, or seller received the drug, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give one notice, that a drug or device introduced into intrastate commerce by said manufacturer is to be used for conditions, purposes or uses other than the ones for which it is offered, the manufacturer is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26638 and 26662, Health and Safety Code. s 10409. Prescription Ophthalmic Devices. The quality standards for prescription ophthalmic devices shall be the 1972 standards of the American National Standards Institute Z80.1 and Z80.2. Note: Authority cited: Section 2541.3, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 2541.3, Business and Professions Code. s 10410. Exemption for Prescription Devices. A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from Section 26638 of the code if all the following conditions are met: (a) The device is in the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device and is to be sold only to or on the prescription or other order of such practitioner for use in the course of the practitioner's professional practice. (b) The label of the device (other than surgical instruments) bears: (1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ________," or "Caution sale of this device is restricted to sale by or on the order of a ________." The blanks to be filled with the word "physician," "dentist," "veterinarian," or with the descriptive designation of any other practitioner licensed by the law of the State of California; and (2) The method of its application or use. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26638 and 26643, Health and Safety Code. s 10415. Exemption for Prescription Drugs and Veterinary Drugs. (a) Exemption for Prescription Drugs. A drug subject to the requirements of Section 26660 of the code, shall be exempt from Section 26638 if all the following conditions are met: (1) The drug is: (A) In the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale distribution of prescription drugs; or (B) In the possession of a pharmacy or a public health agency, regularly and lawfully engaged in dispensing prescription drugs; and is to be dispensed in accordance with Section 26662. (2) The label of the drug bears: (A) The statement "Caution: Federal law prohibits dispensing without prescription," or "Caution: Not to be dispensed without a prescription"; and (B) The recommended or usual dosage; and (C) The route of administration, if it is not for oral use; and (D) If it is fabricated from two or more ingredients and is not designated conspicuously by a name recognized in an official compendium the quantity or proportion of each active ingredient and if it is not for oral use the names of all other ingredients. Provided, however, that the information referred to in subdivisions (B), (C), and (D) of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed, and, in the case of ampuls, too small or otherwise unable to accommodate a label but which are packaged in a container from which they are withdrawn for dispensing or use, the information referred to in subdivision (A) of this subparagraph may be placed on the outside container only. (3) The labeling of the drug (which may include brochures readily available to licensed practitioners) bears information as to the use of the drug by practitioners licensed by law to administer it: provided, however, that such information may be omitted from the labeling if it is contained in scientific literature widely disseminated among practitioners licensed by law to administer the drug. (b) Exemption for Veterinary Drugs. A drug intended solely for veterinary use which, because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from Section 26638 of the code if all the following conditions are met: (1) The drug is in the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of veterinary drugs and is to be sold only to or on the prescription or other order of a licensed veterinarian for use in the course of the veterinarian's professional practice. (2) The label of a drug bears: (A) The statement "Caution: Federal law restricts this drug to sale by or on the order of a licensed veterinarian," or "Caution: To be sold only by or on the order of a licensed veterinarian"; and (B) The recommended or usual dosage; and (C) The route of administration if it is not for oral use; and (D) The quantity or proportion of each active ingredient if it is fabricated from two or more ingredients and is not designated conspicuously by a name recognized in an official compendium. Provided, however, that the information referred to in subdivisions (B), (C), and (D) of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed. (3) The labeling of the drug (which may include brochures readily available to licensed veterinarians) bears information as to use of the drug by licensed veterinarians; provided, however, that such information may be omitted from the labeling if it is contained in scientific literature widely disseminated among veterinarians licensed by law to administer such drug. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26660 and 26662, Health and Safety Code. s 10416. Exemptions for Drugs Dispensed by Licensed Practitioners. Note: Authority cited: Sections 102, 208 and 26202, Health and Safety Code. s 10417. Formulary of Inequivalent Generic Drug Types and Drug Products for Which Substitution Poses a Threat to Health and Safety. (a) The generic drug types or drug products listed in the formulary below have been determined, pursuant to Business and Professions Code Section 4047.7, to have demonstrated clinically significant biological or therapeutic inequivalence and which, if substituted in accordance with Business and Professions Code Section 4047.6, would pose a threat to the health and safety of patients receiving such medications. FORMULARY (1) Generic Drug Types (2) Drug Products (b) Any person requesting the inclusion, addition, or deletion of any generic drug type or drug product to the formulary shall submit such re quest to the Department of Health Services in accordance with the following: (1) Submissions supporting the inclusion, addition, or deletion of any generic drug type or drug product to the formulary shall consist of evidence of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience, on the basis of which it could be fairly and responsibly determined by the Director that a generic drug type or drug product demonstrates, or does not demonstrate, clinically significant biological or therapeutic inequivalence and which, if substituted for another drug product under the provisions of Section 4047.6 of the Business and Professions Code would pose a threat to the health and safety of patients receiving prescription medication. (2) Submissions shall adequately identify all drug products involved by name of manufacturer, lot number(s), and dosage form(s) and should demonstrate the condition(s) of use (e.g., duration, frequency, etc.) of any such drug product where substitution poses a threat to the health and safety of the patient. (3) Submissions shall be made in triplicate to Food and Drug Branch, Department of Health Services, Sacramento, CA 95814. (4) Any information submitted shall be considered to be public information. Note: Authority cited: Section 4047.7, Business and Professions Code. Reference: Sections 4047.6 and 4047.7, Business and Professions Code. s 10420. Label Requirements (26254). s 10425. Applications. (a) Each new drug application submitted for filing with the Department shall be in duplicate. If any part of the application is in a foreign language, an accurate and complete English translation shall be appended to that part. (b) An application shall not be accepted for filing if only one copy is submitted or if it is incomplete on its face in that: (1) It does not contain all the matter required by clauses (1), (2), (3), (4) and (6), of Section 26670 of the code. (2) It does not state the conditions under which the drug or device is to be used; or (3) The specimen of labeling proposed for use upon or within the retail package does not expressly or by reference to a brochure or other printed matter prescribe, recommend, or suggest the use of the drug or device under such conditions. (c) The date on which an application is received by the Department shall be considered to be the date on which the application is filed, and the Department shall notify the applicant of such date. If the applicant withdraws the application, it shall be considered as not having been filed. (d) The applicant may file an amendment to an application which has been filed and is pending before the Department, but in that case the unamended application shall be considered as having been withdrawn and the amended application shall be considered as having been filed on the date on which the amendment is received by the Department. The Department shall notify the applicant of such date. (e) After an application has become effective with respect to a drug or device the applicant may file a supplemental application with respect thereto setting forth any proposed change in the conditions under which the drug or device is to be used in the labeling thereof, in any circumstance relating to its production, or in any other information contained in the effective application. Such supplemental application may omit statements in the effective application concerning which no change is proposed. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26670, Health and Safety Code. s 10430. Notification of Applicant (26289). s 10435. Insufficient Information in Application (26290). s 10437. Suspension of Effective Application (26290.5). s 10438. Untrue Statements in Applications (26290) (e) and 26290.5 (2). s 10440. Exemptions from Section 26670. A shipment or other delivery of a new drug or device is exempt from the operation of Section 26670 of the code if: (a) The exemption is claimed pursuant to Section 26679 of the code, and (b) The conditions of Title 21, Code of Federal Regulations, Part 312 are satisfied for drugs or the conditions of Title 21, Code of Federal Regulations, Part 812 are satisfied for devices, or the conditions of Title 21, Code of Federal Regulations, Part 813 are satisfied for devices which are intraocular lenses. Note: Authority cited: Sections 208, 26202 and 26679, Health and Safety Code. Reference: Section 26679(e), Health and Safety Code. s 10445. Exemptions from Section 26288 of the Code (26292 (2) (3)). s 10446. Exemptions for Dental Laboratories. (a) Dental laboratories which manufacture dental prostheses shall be exempt from the licensing provisions of Section 26685 of the Health and Safety Code until such time that the health hazards, if any, have been identified and effective procedures for their prevention have been established by the Department after consultation with the California State Board of Dental Examiners, the dental profession and the dental laboratory industry. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26693(g), Health and Safety Code. s 10450. Form of Guaranty (26297). s 10455. Expiration of Guaranty (26301). s 10460. Presentation (26341). s 10750. Label Requirements for Foods and Dietary Supplements. (a) Any food or dietary supplement, as defined in Title 17, California Code of Regulations, Division 1, section 10200, that contains any amount of a substance listed in Table 10750 A shall comply with the following: (1) The label of foods and dietary supplements that have a total surface area available to bear labeling of 12 square inches or more shall bear the following notice in the manner prescribed in paragraph (a)(2) of this section: NOTICE: This product contains (name of substance(s) and common name(s) if different). Read and follow directions carefully. Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health. Consult your physician if you have frequent diarrhea or if you are pregnant, nursing, taking medication, or have a medical condition. (2) The notice required by paragraph (a)(1) of this section shall: (A) Be enclosed by a 0.5 point box rule with 2.5 points of space around the notice, (B) Utilize at least one point leading, (C) Have a type that is kerned so the letters do not touch, (D) Be all black or one color type, printed on a white or other neutral contrasting background, (E) Utilize single easy to read type style such as Helvetica Regular and upper and lower case letters, (F) Be in type size no smaller than 8 point, (G) The word "NOTICE" shall be in all upper case letters, and (H) The sentence "Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health." shall be underlined and highlighted by bold or extra bold type, such as Helvetica Black. (3) Foods and dietary supplements in small packages that have a total surface area available to bear labeling of less than 12 square inches shall include the notice required by paragraph (a)(1) in the format specified in (a)(2) in a package insert or a tag attached to the package and bear the following label notice in the manner prescribed in paragraph (a)(4) of this section: NOTICE: Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health. See package insert (or attached tag) for additional information. (4) The notice required by paragraph (a)(3) of this section shall: (A) Be enclosed by a 0.5 point box rule with 2.5 points of space around the notice, (B) Utilize at least one point leading, (C) Have a type that is kerned so the letters do not touch, (D) Be all black or one color type, printed on a white or other neutral contrasting background, (E) Utilize single easy to read type style as Helvetica Regular and upper and lower case letters, (F) Be in type size no smaller than 6 point, (G) The word "NOTICE" shall be in all upper case letters, and (H) The sentence "Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health." shall be underlined and highlighted by bold or extra bold type, such as Helvetica Black. (b) This section does not apply to foods and dietary supplements containing the leaf gel or leaf juice of aloe (Aloe ferox Mill. or Aloe vera (L.) N.L. Burm.) or concentrations thereof, providing that the food or dietary supplement does not contain another substance listed in Table 10750 A. Table 10750 A-Listed Substances Common Name Plant Part Botanical Name aloe also known as latex Aloe ferox Mill. cape aloe aloe also known as latex Aloe vera (L.) N.L.Burm., aloe vera also known as Aloe barbadensis Mill. or Aloe vulgaris Lamk. buckthorn berry Rhamnus catharticus L. cascara also known as bark Rhamnus purshianus DC. cascara sagrada also known as Rhamnus purshiana DC. or Frangula purshiana (DC.) JG Cooper frangula also known as bark Rhamnus frangula L. also buckthorn known as Frangula alnus Mill. rhubarb root also known as root Rheum officinale Baill., as Chinese rhubarb Rheum palmatum L., Rheum rhaponticum L., or Rheum tanguticum, Maxim. ex Balf. senna also known as leaf Senna alexandrina P. Mill. Alexandria senna or or pod also known as Cassia senna Tinnevelly senna L., Cassia angustifolia Vahl. Cassia acutifolia Del., or Senna angustifolia (Vahl) Batka senna also known as leaf Senna obtusifolia (L.) Irwin sicklepod senna or pod and Barneby also known as Cassia obtusifolia (L.) senna leaf Senna tora (L.) Roxb. also or pod known as Cassia tora (L.) Note: Authority cited: Sections 100275, 110065 and 110100, Health and Safety Code. Reference: Sections 110175, 110290, 110660, 110705, 110760, 110765 and 110770, Health and Safety Code. s 10755. Truth of Labeling (26456). s 10760. Metal Coated Dragees and Ornaments (26470 (2)). s 10765. Toxic Substances -Use of (26470 (2)). s 10770. Secondhand Use of Barrels. (a) No wooden barrel or keg that has ever been used as a container for other than food products may be re-used for the storage and/or conveyance of any food product. (b) Barrels or kegs that have been used as containers for food products may be re-used for storage and/or conveyance of other food products. Provided: they are thoroughly cleaned and are in a sanitary condition at the time of re-use. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26524, Health and Safety Code. s 10775. Custard Fillings for Pastry (26470 (4)). s 10780. Containers, Cadmium Plated (26470 (6)). s 10785. Packing Materials (26470 (6)). s 10786. Apricot Kernels. (a) Apricot kernels sold or distributed into food channels are misbranded unless the package or container is conspicuously labeled: "Apricot kernels may be toxic; very low quantities may cause reactions." (b) Subsection (a) does not apply to: (1) Firms selling bulk apricot kernels for processing into macaroon paste or marzipan where the firms furnish to the Department upon its request, documentation acceptable to the Department, of its intended use as macaroon paste or marzipan, and the apricot kernels are clearly labeled: "Not suitable for food use without further processing." (2) Fresh apricots or to apricot kernels added to canned apricots as an optional flavor agent. Note: Authority cited: Section 26202, Health and Safety Code. Reference: Sections 26400 and 26520, Health and Safety Code. s 10790. Candy, Trinkets in, Prohibited (26472 (b)). s 10795. Blending and Dilution of Certified Coal Tar Colors (26472 (c)). s 10800. Labeling, Misbranding (26490 (1)). s 10805. Required Statements, When Exempt (26491). s 10810. Prominence of Required Statements (26492). s 10815. Prepackaged Candy and Cookies, Retail Sale of Food from Bulk Containers (Label Exemptions) (26492). s 10820. Exemption upon Proper Labeling. s 10825. Conformity to Definitions and Standards of Identity (26493). s 10826. Temporary Permits for Intrastate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity. (a) To obtain a temporary permit for intrastate shipment of experimental packs of food varying from the requirements of definitions and standards of identity, a person shall file with the Department a written application in triplicate containing the following: (1) Name and address of the applicant. (2) A statement of whether or not the applicant is regularly engaged in producing the food involved. (3) A reference to the applicable definition and standard of identity (citing applicable section of regulations). (4) A full description of the proposed variation from the standard. (5) The basis upon which the food so varying is believed to be wholesome and nondeleterious. (6) The amount of any new ingredient to be added; the amount of any ingredient, required by the standard, to be eliminated; any change of concentration not contemplated by the standard; or any change in name that would more appropriately describe the new product under test. If such new ingredient is not a commonly known food ingredient, a description of its properties and basis for concluding that it is not a deleterious substance. (7) The purpose of effecting the variation. (8) A statement of how the variation is of potential advantage to consumers. (9) The labeling proposed to be used for the food so varying. (10) The period during which the applicant desires to introduce such foods into intrastate commerce, with a statement of the reasons supporting the need for such period. (11) The probable amount of such food that will be distributed. (12) The areas of distribution. (13) The address at which such food will be manufactured. (b) The applicant for a permit described in (a) shall provide the Department, upon request, with samples of the food varying from the standard and any additional information deemed necessary by the Department. (c) If the Department concludes that the variation may be advantageous to consumers and will not result in failure of the food to conform to any provision of the act except Section 26556, a permit shall be issued to the applicant for intrastate shipment of such food. The terms and conditions of the permit shall be those set forth in the application with such modifications, restrictions, or qualifications as the Department may deem necessary and state in the permit. (d) The terms and conditions of the permit may be modified at the discretion of the Department or upon application of the permittee during the effective period of the permit. (e) The Department may revoke a permit for cause, which shall include but not be limited to the following: (1) That the permittee has introduced a food into intrastate commerce contrary to the terms and conditions of the permit. (2) That the application for a permit contains an untrue statement of a material fact. (3) That the need therefor no longer exists. (f) During the period within which any permit is effective, it shall be deemed to be included within the terms of any guaranty or undertaking otherwise effective pursuant to the provisions of Section 26300 of the act. (g) If an application is made for an extension of the permit, it shall be accompanied by a description of experiments conducted under the permit, tentative conclusions reached, and reasons why further experimental shipments are considered necessary. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26513, Health and Safety Code. s 10830. Designation of Ingredients (26495). s 10835. Listing Ingredients in Order of Predominance (26495 (2)). s 10840. Dietary Food Labeling (26496 (1)). s 10841. Label Statements Relating to Emergency Food Packs. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 26467, Health and Safety Code. s 10842. Saccharin Warning Labeling. (a) The saccharin warning labeling requirements of the Federal Saccharin Study and Labeling Act, Public Law 95-203, 1977, and the compliance guidelines promulgated under authority of that act, shall be applicable to all saccharin containing products in intrastate commerce in this State. (b) These labeling requirements and guidelines shall apply only to products introduced into intrastate commerce after the effective date of this section. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26206, Health and Safety Code. s 10845. Artificial Flavoring or Coloring, Chemical Preservatives (26496 (2)). s 10850. Form of Guaranty (26521). s 10855. Expiration of Guaranty (26525). s 10860. Exemptions from Labeling Requirements (26542). s 10862. Adoption of Federal Requirements. Subchapter B, Title 21, Code of Federal Regulations and amendments thereto shall be included as the requirements of this Department. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26203, 26205-26209, 26438, 26510 and 26559, Health and Safety Code. s 10865. Presentation (26565). s 11375. Sources of Poultry Meat. Note: Authority cited: Section 26540, Health and Safety Code. Reference: Sections 26540 and 26541, Health and Safety Code. s 11376. Conditions for Use. Note: Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code. s 11377. Methods for Treating. Note: Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code. s 11378. Disposal of Unfit Poultry Meats. Note: Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code. s 11380. Required Health Warning on Labels of Raw Milk and Raw Milk Products. (a) Raw Milk and raw milk products shall bear the following warning on the principal display panel or panels of the label: WARNING Raw (unpasturized) milk and raw milk dairy products may contain disease-causing micro-organisms. Persons at highest risk of disease from these organisms include newborns and infants; the elderly; pregnant women; those taking corticosteroids, antibiotics or antacids; and those having chronic illnesses or other conditions that weaken their immunity. (b) The warning shall appear within a heavy borderline in a color sharply contrasting to that of the background. The signal word "WARNING" shall appear in capital letters of ten point type or greater. The remaining text of the warning shall be printed in capital letters of six point type or greater. All characters in the warning message shall be in a sans serif type style. (c) For purposes of this section, the following definitions shall apply: (1) "[R]aw" means unpasteurized; (2) "[R]aw milk product" means any food which contains raw milk, and shall include, but not be limited to, cheese (except when ripened or cured at least 60 days pursuant to sections 37975 and 38001 of the Food and Agricultural Code), cream, butter and kefir. (d) Raw milk or raw milk products packaged in recyclable glass containers which are sold only at the location where the raw milk or raw milk product is produced (including containers which are delivered directly from the point of production to a retail customer by agents or employees of the production facility), and which have a principal display panel only on the container cap, may instead have attached to the container a tag containing the warning message set forth in subsection (a), provided that the tag will stay attached to the container and remain readable under customary conditions of storage and transportation, excluding intentional removal after purchase by, or delivery to, the retail customer. The tag shall be attached in a conspicuous location on the container. The warning message portion of the tag shall be subject to all other requirements of this section. The tag may, to the extent authorized by law, contain any other information desired by the production facility. For purposes of this subsection, a "tag" can be of any shape, material, and design, so long as the warning message is conspicuous and easily readable. (e) Any raw milk or raw milk product which does not bear a label meeting the requirements of this section is misbranded. (f) This section does not apply to raw milk and raw milk products produced and packaged before February 21, 1991. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26400 and 26550, Health and Safety Code. s 11600. Cold Storage Regulations. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 208, Health and Safety Code. s 11601. Cold Storage Licenses. (a) Cold Storage licenses shall be valid for a two-year period from date of issue and are not transferable. The fee for the license is $100.00. (b) Application for a Cold Storage license shall be made on State Department of Health form #EH-7. (c) The fee shall accompany the application and shall not be refundable. (d) The licensee shall immediately notify the Department of any change in the information which was submitted on the license application. Note: Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code. Note: Authority cited: Sections 208 and 28182, Health and Safety Code. Reference: Sections 28165-28186, Health and Safety Code. s 12001. Custard and Cream Fillings for Pastry (28208). (a) Perishable bakery products shall include, but are not limited to, products such as cream-filled pies, pumpkin pies, cakes, pastries, custard, meringues and cheese cake, which consist in whole or in part of milk or milk products, eggs, synthetic fillings or any ingredients capable of supporting rapid and progressive growth of infectious or toxicogenic microorganisms. (b) Perishable bakery products shall be kept, displayed, transported or maintained at or below 45 degrees Fahrenheit. This Section shall not apply to products during reasonable periods of preparation or handling not to exceed two hours. (c) Perishable bakery products when packaged shall be labeled "Perishable -Keep Refrigerated." (d) Uncut pumpkin, sweet potato, yam and squash pies baked in the shell or so prepared that the filling reaches a temperature of at least 140 F, for 5 minutes and which are packaged individually at the point of production to prevent contamination, may be considered not to be a perishable product and refrigeration is not required. When packaged, the above pies shall be labeled "Refrigerate after opening." (e) Uncut citrus meringue pies having a filling of 4.5 pH or lower, and packaged individually at the point of production to prevent contamination may be considered not to be a perishable product and refrigerator is not required. When packaged, citrus meringue pie shall be labeled "Refrigerate after opening." (f) Marshmallow topping, or other filling or topping products, with a sugar-water ratio of at least 2.1 to 1 are not perishable and do not require refrigeration. Note: Authority cited: Sections 102, 208 and 28214, Health and Safety Code. Reference Section 28208, Health and Safety Code. s 12100. Definitions. (a) Retail food establishment means any room, building, vehicle, place, or portion thereof, maintained, used, or operated for or in conjunction with, the retail sale of food or preparation of food and includes, but is not limited to: (1) "Retail Food Production and Marketing Establishment" as defined in Section 28802 of the Health and Safety Code. (2) "Bakery" as defined in Section 28190 of the Health and Safety Code. (3) "Roadside Stand" as defined in the California Administrative Code, Title 17, Section 13650. (4) "Restaurant" as defined in Sections 26595(c) and 28522 of the Health and Safety Code. (5) "Itinerant Restaurant" as defined in Sections 26595(c) and 28523 of the Health and Safety Code.(6) "Vehicle" as defined in Sections 26595(c) and 28524 of the Health and Safety Code. (7) "Mobile Food Preparation Units" as defined in the California Administrative Code, Title 17, Section 13601. (8) "Vending Machines" as defined in Section 28525 of the Health and Safety Code. (b) Menu misrepresentation means any false statement on a menu. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Sections 26460, 26581 and 26590, Health and Safety Code. s 12101. Application for Participation. Application for participation shall be made by letter from the local health department to the Director of the Department of Health. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26581, Health and Safety Code. s 12102. Local Enforcement Authorization. (a) A local department authorized as a local retail food enforcement program by the Department shall enforce Department regulations and the following chapters, articles and sections of Division 21 of the Health and Safety Code pertaining to the preparation, handling and sale of foods in retail food establishments. (1) Definitions and General Provision (Chapter 1). (A) Short title and definitions (Article 1) Sections 26000, 26001, 26002, 26004, 26006, 26007, 26008, 26011, 26012, 26013, 26014, 26015, 26016, 26017, 26018, 26019, 26023, 26024,26025, 26026, 26028 and 26029. (B) General provisions (Article 2) Sections 26050 through 26052. (2) Administration (Chapter 2). (A) Generally (Article 1) Section 26214. (B) Inspection and sampling (Article 3) Sections 26230 through 26235. (C) Publicity (Article 4) Sections 26250 through 26252. (3) Guarantees (Chapter 3) Sections 26300 through 26307. (4) Packaging, labeling and advertising (Chapter 4). (A) Generally (Article 1) Sections 26400, 26401, 26402, 26405, 26406, 26407 and 26408. (B) Fair packaging and labeling (Article 2) Sections 26430, 26431, 26432, 26436 and 26439. (C) Advertising, including menu misrepresentation (Article 3) Sections 26460, 26461, 26461.5, 26462, 26467 and 26468. (5) Food (Chapter 5). (A) Generally (Article 1) Section 26500. (B) Enrichment of food and food products (Article 2.5) Sections 26516, 26517 and 26518. (C) Adulterated food (Article 3) Sections 26520 through 26540. (D) Misbranded food (Article 4) Sections 26550 through 26569.7. (E) Potentially hazardous foods (Article 5) Section 26570. (F) Frozen products (Article 5.5) Section 26575. (G) Local enforcement (Article 6) Sections 26580 through 26590. (H) Hamburger and imitation hamburger (Article 7) Sections 26595 through 26599. (6) Penalties and Remedies (Chapter 8) (A) Penalties (Article 1) Sections 26801 and 26802. (B) Proceedings (Article 2) Sections 26811, 26812 and 26813. (C) Seizure and Embargo Sections 26830 through 26837. (D) Injunctions (Article 4) Sections 26850 and 26851. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Sections 26583 and 26590, Health and Safety Code. s 12103. Laboratory Examinations. (a) A local health department shall be able to make the following laboratory examinations in order to qualify for local enforcement of retail food establishments. (1) Examination of Fresh Meats shall be in accord with the methods of analysis of the Association of Official Analytical Chemists (AOAC) and supplements thereto for the following: (A) Fat content of ground and chopped beef and pork sausage. (B) Presence of preservatives including sulfite, borates, nitrite and nitrate. (C) Presence of starch by testing with iodine. (D) Presence of vegetable protein or other extenders. (2) Examination of Alcoholic Beverages. (A) Determine alcoholic proof by AOAC methods. (B) Micro analytical examination to determine and identify insects and other filth adulteration. (3) Filth Examination of Various Foods. (A) Presence of insects by macro or micro analytical methods. (B) Presence of rodent urine by the AOAC method of analysis. (C) Presence and identification of mold and yeast by microanalytical methods. (D) Verification of foreign material by microscopic and macroscopic examination. (b) Laboratory examinations shall be performed in a Public Health Laboratory or a laboratory designated by the local health department and approved by the Department. (c) Laboratory examinations shall be performed by the professional staff employed in the laboratory designated by the local health department and approved by the Department. (d) The laboratory personnel shall complete Department approved training. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26583, Health and Safety Code. s 12104. Personnel Training. (a) Local health department personnel shall complete state approved training in the following areas: (1) Enforcement of statutes and regulations relating to mislabeling, false advertising and adulteration of foods in retail food establishments. (2) Observation and recording of violative conditions in narrative reports that can be used for legal actions. (3) Determining alcoholic proof of liquor products for mislabeling and candling of full or partly filled liquor bottles to determine adulteration. (4) Procedures for voluntary condemnation and destruction of violative food products. (5) Procedures for the embargo of violative food products and the release of an embargo. (6) Collection of representative official samples of violative food and potential adulterants. (7) Completing official sample receipt forms and memorandum of instruction for laboratory examinations. (8) Procedures for the forfeiture, condemnation and destruction of food found to be adulterated or misbranded. (9) Preparation of statements of facts for referrals of violative conditions to the district attorney. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code. s 12105. Staff Qualifications. The minimum qualifications for professional staffing by local health departments to carry out the local enforcement of the Sherman Food, Drug, and Cosmetic Law and Department regulations relative to retail food establishments shall be a registered sanitarian. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code. s 12106. Reporting Requirements. Each local health department shall submit quarterly reports to the Department that summarize enforcement activities for retail food establishments. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code. s 12107. Enforcement Authority for Menu Misrepresentation. (a) Menu is a form of advertising. A local health department authorized by the Department to enforce only menu misrepresentation shall enforce the following sections of the Health and Safety Code: (1) Advertising (Chapter 4, Article 3) Sections 26460 and 26461. (2) Penalties (Chapter 8, Article 1) Sections 26801 and 26802. (3) Proceedings (Chapter 8, Article 2) Sections 26811 and 26812. (4) Injunctions (Chapter 8, Article 4) Sections 26850 and 26851. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Sections 26460, 26461 and 26581, Health and Safety Code. s 12108. Personnel Training. (a) Personnel from local health departments who are assigned to enforce the Sherman Food, Drug, and Cosmetic Law as it relates only to menu misrepresentation in retail food establishments shall participate and complete state approved training as required in Section 12104 or meet the following training requirements: (1) Enforcements of statutes and regulations relating to false advertising in food menus that are used in retail food establishments. (2) Recording violative conditions in narrative reports of observation that can be used for legal action. (3) Preparation of statements of facts for referrals or violative conditions to the district attorney. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Sections 26583 and 26590, Health and Safety Code. s 12109. Staff Qualifications. The minimum qualifications for staffing by local health departments to enforce the Sherman Food, Drug, and Cosmetic Law as it relates to menu misrepresentation shall be at the level of a registered sanitarian. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code. s 12110. Reporting Requirements. A local health department authorized by the Department to enforce only menu misrepresentation shall submit semiannual reports to the Department that summarize enforcement activities. Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code. Reference: Section 26590, Health and Safety Code. s 12200. Vegetable Juice, Preparation and Sale of Fresh (28281-28282). s 12205. Premises. s 12210. Materials. s 12215. Extracting Machines. s 12220. Storage and Sale. s 12225. Employees. s 12230. Revocation of Permit. s T17-12235. Light, Ventilation, and Plumbing (28281). Note: Authority cited: Sections 208 and 28281, Health and Safety Code. Reference: Section 28281, Health and Safety Code. s 12240. Water Supply. Note: Authority cited: Sections 208 and 28281, Health and Safety Code. Reference: Section 28281, Health and Safety Code. s T17-12245. General Plant Sanitation; Floors, Walls, Ceilings, Etc. The floors, walls, ceilings, partitions, posts, doors and other parts of all preparation and processing areas shall be of such materials, construction and finish that they may be readily and thoroughly cleaned. The floors in all areas where water is used in the operation are to be so constructed and of such material as to be watertight and they shall be maintained in such condition as to stay watertight. All areas used for edible products shall be separate and distinct from those used for inedible products, such as fish meal reduction plants. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 28282, Health and Safety Code. s 12250. Areas, Equipment, and Operations to Be Sanitary. (a) Areas, equipment and utensils used for preparing, storing or otherwise handling any food product and all other parts of the establishment shall be kept clean and in a sanitary condition. Areas in which any food product is prepared, processed, stored or handled, including walls, ceilings, and overhead structures of such areas, shall be kept as reasonably free from moisture as is practicable. In such areas there shall be no dripping from any source, including ceilings and overhead structures, that may contaminate the product. (b) Equipment and utensils used for preparing, processing or otherwise handling any food product shall be of such materials and construction that they can be readily and thoroughly cleaned. Pipelines used to convey fluid or semi-fluid products shall be so constructed that they can be readily and thoroughly cleaned. (c) Operations and procedures involving the preparation, storing or handling of any food product shall be strictly in accord with good sanitary practice. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 28282, Health and Safety Code. s 12255. Use of Poisonous Insecticides and Rodenticides. (a) Every practical precaution shall be taken to keep establishments free from flies, rats, mice and other vermin. If necessary, rodent-proof rooms shall be provided for materials which might become contaminated by these pests. (b) The use of insecticides, or rodenticides, toxic to humans, in areas where any food products, not adequately protected, is being stored or handled is prohibited. (c) Poisonous insecticides and rodenticides may be used under buildings, wharves, outbuildings, or similar places, or where adequately protected packaged products are stored; only, if adequate precautions are taken to eliminate the possibility of said poisons being accidentally spilled, or carried, by any means, to areas where these poisons are prohibited. These poisons are to be adequately protected from possible contact by children, or domestic animals, and are to be plainly and distinctly labeled for identification by adults. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 28282(a), Health and Safety Code. s 12260. Empty Container Storage. Empty cans, jars, lids, covers, barrels, drums, etc., must be clean when filled with food products. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 28282, Health and Safety Code. s 12265. Bactericidal Treatment of Utensils and Equipment in Food Processing Establishments (28282(c)). Note: Authority cited: Sections 208 and 28282, Health and Safety Code. Reference: Section 28282(c), Health and Safety Code. s 12270. Tagging Insanitary Equipment. Note: Authority cited: Sections 208 and 28282, Health and Safety Code. Reference: Section 28282, Health and Safety Code. s 12275. Personal Hygiene. (a) The employees of the establishment who handle any food product shall keep their hands clean; and, after visiting the toilet room or urinals, shall wash their hands before handling any food product or implement used in the preparation of the product. (b) Outer clothing and gloves worn by persons who handle any food product shall be clean and of material that can be readily cleaned. (c) Such practices as spitting on the floor and using empty cans, jars, or other containers as drinking cups, or for purposes other than those originally intended, are forbidden. (d) Care shall be taken to prevent the contamination of food products with perspiration, hair, cosmetics, medicaments and the like. Adequate head coverings must be worn by all men and women while engaged in the preparation or handling of any food product. (e) Smoking by any person shall not be permitted while preparing or handling any food product or while handling empty cans, jars, lids, barrels, drums or other receptacles used for food products. (f) The use of fingernail polish by any person preparing, processing, or handling any food product without gloves whereby the product might become contaminated, is prohibited. (g) No clothing, shoes, boots, aprons, etc. shall be kept or stored in any area where any food product is prepared, processed, or handled; except, in or on facilities specifically provided for this purpose. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 28282(d), 28291 and 28293, Health and Safety Code. s T17-12280. Sanitary Facilities. Adequate sanitary facilities and accommodations shall be furnished by every food packing establishment. Of these the following are specifically required: (a) Dressing rooms, and toilet and urinal rooms shall be sufficient in number and conveniently located. These rooms shall be well lighted, sufficiently ventilated to insure sanitary conditions, vented to the outside, and meet all requirements as to sanitary construction and equipment. All doors entering such rooms shall be self-closing. All windows shall be screened. Such rooms shall be separate from areas in which food products are prepared, stored, or handled. The walls, ceiling, partitions, and other parts of all dressing rooms, toilet rooms, lavatory rooms and urinal rooms shall be of light color and of such construction as to be easily and adequately cleaned. Where five or more persons of both sexes are employed, separate facilities shall be provided for each sex. (b) Sanitary washing facilities, including running hot and cold water, soap and individual towels, shall be provided, and shall be placed in or near toilet and urinal rooms and also at other places in the establishment as may be essential to insure cleanliness of all persons handling any food product. (c) Adequate lockers or cloak rooms for all employees shall be provided and shall be kept clean and well ventilated. (d) Toilet soil lines shall be kept separate from industrial waste lines to a point outside the buildings. Drainage from toilet bowls and urinals shall not be discharged into grease salvage basins, or into open disposal systems. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 28287, 28288, 28289 and 28290, Health and Safety Code. s 12285. Surroundings of Food Packing Establishments (28298). s 12290. Labeling Exemption (28322). s 12295. Form of Affidavit. s 12300. Purchase of Walnut Meats from Producers, Etc. (28336). s 12302. Walnut Shelling Licenses. Note: Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code. s 12305. Production Record Specifications. s 12310. Bill of Sale Specification. s 12315. Condition of Walnut Meats. s 12400. Applicability. Low acid (high pH) foods or acid foods containing low acid ingredients to an extent where a food poisoning hazard may exist when placed in hermetically sealed containers, and which are not processed by steam under pressure must be packed under the supervision of the Department of Public Health. This includes several types or classes of food products, among which are the following: vegetables in acidified brine or oil, vegetable juice cocktails, and various formulated products. s 12405. Acid Requirements. (a) All products subject to Section 12400 found to have a pH greater than 4.6 will be restrained. (b) The pH of low-acid foods may be lowered by the addition of any edible organic food acid such as citric or acetic. Allowance must be made for the fact that certain acids, such as acetic, are quite volatile and rapidly lose their strength when heated in open containers. The Department of Public Health must be consulted to determine the strength and amount of acid to be used for each type of pack and the control measures that are necessary. Note: For illustration purposes only, the following examples are cited: On the basis of 60 percent solids in a final acidified artichoke pack, the following brines are found to furnish the required pH of less than 4.6: (1) Unblanched, 0.6 percent citric acid (80 ounces per 100 gallons) (2) Water blanched, 0.53 percent citric acid (71 ounces per 100 gallons) (3) Acid blanched in a 1 percent citric acid solution for six minutes, 0.24 percent citric acid (32 ounces per 100 gallons) (c) Acidified vegetables from a batch previously inspected and released by the Department of Public Health may be repacked in a packing medium of an edible vegetable oil without official reinspection only when adequate records are maintained clearly showing the batch number of the original batch and the date of release thereof and the batch number of the repacked vegetable. s 12410. Titration by Inspectors. (a) Samples of the acid blanching solutions and brining solution shall be collected, one sample of each to be taken at the beginning of each day's run subsequently at about two-hour intervals during the day. These samples are to be titrated daily by the state cannery inspector. (b) When the blanching or brining solution is changed, or more acid added, the batch number must be changed. A batch is understood to mean all material blanched at one time in a given solution. s 12415. Low Acid Ingredients in Acid Foods. Some foods such as vegetable juice cocktails are made by mixing portions of low acid vegetables with products possessing a safe level of acidity, with a resulting potential food poisoning hazard. The control of acidity for this type of product is based on the examination of the finished product, and is determined directly as pH, which must be below 4.6. Samples of the finished product are to be submitted to the laboratory as requested. s 12420. Formulated Products. By "formulated products" is meant the class of foods that is compounded from a number of ingredients according to a definite formula, and these ingredients when so compounded do not have a pH low enough to render them commercially sterile when processed without steam under pressure. The control of acidity for this type of product is based on the examination of the finished product, and is determined directly as pH, which must be below 4.6. Samples of the finished product are to be submitted to the laboratory as requested. s 12425. Test Equipment. All plants packing food products regulated under Sections 12415 and 12420 shall have and maintain in proper working condition for the use of the state cannery inspector pH determination equipment of the glass electrode type. All plants packing vegetables in acidified brine shall have complete titrating equipment, consisting of burette, standardized alkaline solution, indicator solution, pipettes, and titrating flasks or beakers. All of the above must be kept in clean workable condition at all times. s 12430. Samples to Laboratory. (a) Samples of the finished product, whether brine packed or oil packed from an acid blanch, are to be submitted to the laboratory as requested. (b) Cans should be labeled to show the following: product, date of pack and code number. s 12435. Production Records. Production records shall be kept and a coding system inaugurated as specified by the inspection service. The production record shall show the cooking time and temperature for each batch, also number of containers per batch. s 12440. Inspectors' Reports. A daily report is to be submitted to the Department of Public Health covering the results of the state cannery inspector's titrations on all blanching solutions and/or bines; also a report of his pH determinations to be certain that the acidification procedures are in order. s 12445. Releases. Batches of foods subject to pH control are not to be released by the state cannery inspector until authorization is received from the San Francisco Office. s 12450. Responsibility of Canners. It is the responsibility of every person, group, or organization engaged in the commercial, semicommercial, cooperative, or noncommercial community (church, school, or otherwise) canning or preservation of low-acid foods in hermetically sealed containers, among other things, to achieve commercial sterility in all units packed. s 12451. Cannery Licenses. (a) Cannery licenses will be valid for a two-year period from date of issue and are not transferable. The fee for the license is $100.00. (b) Application for a Cannery license shall be made on State Department of Health form #EH-153. (c) The fee shall accompany the application and will not be refundable. (d) The licensee shall immediately notify the Department of any change in the information which was submitted on the license application. Note: Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code. s 12455. Official Sterilization Processes. All products except those under pH control as defined in Section 12400 through 12445 must meet specific requirements as to initial temperature, process time and temperature, as determined for each product. The Department of Public Health shall be contacted for the latest official sterilization requirements. (See Sections 12790 through 12975.) s 12460. Initial Temperature. The term "initial temperature" as used herein designates the average temperature of the can contents at the time steam is turned on for the process. Just prior to the start of the process, the contents of the container used for checking the initial temperatures should be shaken or stirred and the temperature determined. This container should be representative of the coldest cans in the retort load and should have an initial temperature equal to or greater than the initial temperature specified under "Official Sterilization Process." "Initial temperature" should not be confused with "closing temperature." s 12465. Cleanliness of Materials. All raw material must meet full requirements as to purity, wholesomeness, cleanliness and suitability for canning purposes. To this end the packer must supply any and all necessary equipment, and additional help and measures designed to insure the quality of the product. s 12470. Record of Cooks. Each licensed retort operator shall keep a record of the cooks as required by the State Board of Public Health. (a) The original and a duplicate of the production record must be kept by filling in accurately in complete detail the form approved by the Department of Public Health. Each entry in the record must be made by the operator at the time the specific retort operation is observed and not copied afterward. It must be in legible handwriting and be signed by the operator or operators. (b) Chart of recording thermometer must show full time and temperature as required, otherwise the product will be restrained. (c) Each production record and recording thermometer chart shall be stamped, initialed and numbered by a state cannery inspector before use and must be accounted for. (d) The cook or batch number and size of cans involved must be recorded by the canner in each respective curve of all temperature charts. (e) Production records and charts must be scrutinized and checked by a state cannery inspector before product is released for shipment. s 12475. Coding. (a) Each plant must submit and have approved a code to appear legibly on the cover of each container. This code will show the plant where packed, year packed, the product contained therein, day code, and period code. The period shall be changed every two and one half hours or less. This time interval may be extended to three hours if a petition is filed with the Department demonstrating that adequate consumer protection is provided under those conditions when potentially hazardous products are required to be removed from retail market. If a container such as a glass bottle be used and the cap or cover be too small to permit the coding to be embossed or ink-stamped thereon, it shall be permissible to legibly perforate or ink-stamp the required code on the label, provided the label is securely affixed to the container. s 12480. Requirements. (a) All products must be free from adulteration and misbranding in accordance with Chapter 3 of Division 21 of the Health and Safety Code, and the United States Food, Drug and Cosmetic Act. The product must not be in violation of any state or county law. The net weight or other information as required by law must appear correctly upon labels. (b) Any number of cans deemed necessary shall be cut and examined at any time by representatives of the Department of Public Health. (c) Plants and equipment must comply with necessary requirements as to cleanliness and sanitation and conform to any and all state requirements. (d) Officials of plants must insure the cooperation of all plant personnel. (e) Packers must realize and faithfully fulfill their own responsibilities and obligations to produce a sound, wholesome, and safe product. (f) All packers must fulfill their obligations with respect to maintenance of cannery inspection service according to Article 2 of Chapter 8 of Division 21 of the Health and Safety Code. s 12481. Examination of Can Closures and Can Closure Machines. (a) Visual Examination. During regular production runs, a constant watch shall be maintained for gross maladjustments such as deadheads, cut-overs, and other similar double seam defects. Maintaining this constant check may be accomplished in several ways, depending on the type of closing machine, line speeds, and general equipment layout. It may best be performed by training the closing machine operator to recognize irregularities by visual examination. However, an adequate check program can be maintained through use of other trained personnel. The operator, can closure supervisor, or other qualified personnel shall visually examine, at intervals of not more than thirty minutes, the top seam of a randomly selected can from each seaming station, and shall record his observations. Additional visual seam inspections shall be made immediately after a can-jam in a closing machine, or after start-up of a machine following a prolonged shut-down. All pertinent observations shall be recorded. If irregularities are found, the action taken shall be noted. (b) Tear-down Examination. Tear-down examinations shall be made at a frequency of at least one can per seaming station every four hours or each major fraction thereof. Such examinations shall be made as soon as possible after starting up following a shut-down, waiting only long enough for the machine to "warm up." Cans for visual inspection shall be taken during this warm-up period. The results of the tear-down examinations shall be recorded. (c) General Observations. Following are some of the various factors which influence double seam quality and which shall be examined in the course of the can seam examination: (1) Condition of the seaming equipment -whether or not the mechanical operation and adjustment of the closing machine give the proper seam contours. (2) Can material -variations in tinplate thickness. (3) Can size -roll contours change with can size to accommodate variations in plate thickness. Other pertinent observations shall also be recorded indicating the presence or absence of such defects as cut-overs, droops, etc. Note: Authority cited: Section 28440, Health and Safety Code. Reference: Sections 28310-28322, Health and Safety Code. s 12482. Required and Optional Seam Measurements. (a) Optical System (use of seam scope or projector) Required Optional Body hook Width (length, height) Overlap Cover hook Tightness (observation for wrinkle) Countersink Thickness (b) Micrometer Measurement System Required Optional Cover hook Overlap (by calculation) Body hook Countersink Width (length, height) Thickness Tightness (observation for wrinkle) Regardless of whether or not a seam scope or seam projector is used, the double seam shall be torn down for examination. (c) Two measurements shall be made for each double seam characteristic if a seam scope or seam projector is used. If a micrometer is used, three measurements shall be made at points approximately 120 apart, excluding the side seam. The high and low measurements must fall within limits considered to be normal for the conditions. With regard to measurement limits, the canner shall follow the working limits recommended by the can supplier. Overlap length can be calculated by the following formula: The theoretical overlap length = CH+BH+T = W where CH = coverhook BH = body hook [FNa1] T = cover thickness, and W = seam width (height, length) [FNa1] In general practice, 0.010 may be used for the tinplate thickness. (d) Records shall be kept on all seam examinations. The form of such records shall be the choice of the canning company, but the records must show the frequency of visual and tear-down inspections, and the measurements made. It is suggested that sample forms be obtained from the can supplier. For the purposes of State inspection, records of seam examinations must be filed and held for inspection by the State Department of Public Health. Note: Authority cited: Section 28440, Health and Safety Code. Reference: Sections 28310-28322, Health and Safety Code. s 12485. Standards for Water Used in Fish Canneries. Waters used in fish canning operations within canneries shall conform to the following standards: (a) Water satisfactory without treatment. (1) For whole fish handling operations: (A) Not subject to contamination with human fecal discharges. (B) Maximum of 7 E. coli organisms per cc. (C) Bacterial standard may be exceeded in not more than 20 percent of the samples. (2) For cut fish handling operations: (A) Not subject to contamination with human fecal discharges. (B) Maximum of 7 E. coli organisms per cc. (C) Bacterial standard may be exceeded in not more than 5 percent of the samples. (b) Waters satisfactory after treatment: (1) For whole fish handling operations: (A) Not subject to gross contamination with human fecal discharges before treatment. (B) Maximum of 3 E. coli organisms per cc. after treatment. (C) Bacterial standard may be exceeded in not more than 20 percent of the samples. (2) For cut fish handling operations: (A) Not subject to gross contamination with human fecal discharges before treatment. (B) Maximum of 3 E. coli organisms per cc. after treatment. (C) Bacterial standard may be exceeded in not more than 5 percent of the samples. (D) The treatment shall include filtration or the equivalent as one of the steps of the treatment process. Samples for bacteriological analysis shall be analyzed by an approved method set forth in the latest edition of the APHA manual entitled "Standard Methods for the Examination of Water and Sewage." Those methods shall be employed which give the most specific reliable means of measuring organisms having their origin in the intestines of man and other warm-blooded animals. s 12490. Establishments and Premises in or on Which Food Products Are Prepared, Handled, Stored, or Packed Shall Be Maintained in a Sanitary Condition. The following general requirements shall be complied with: (a) Light. There shall be light of good quality and well distributed wherever the food product may become contaminated. (b) Ventilation. There shall be ventilation sufficient to insure sanitary conditions. (c) Drainage and Plumbing. There shall be efficient drainage and plumbing systems for the premises. All closed drains shall be properly installed with approved traps and vents. s 12495. Water Supply. Potable water supply for plant use shall be clean, and bacterially suitable with adequate facilities for its distribution in the plant and its protection against contamination and pollution. In those cases where ocean water is used in the handling of a food product, such as in fish canneries, the ocean water must meet the bacteriological and quality standards for such water as set forth in Section 12485 of these regulations. In cases where nonpotable water is used, there shall be no cross connection between the nonpotable supply line system and the potable water supply line system. Any nonpotable supply line system shall be painted a color to distinguish it from any potable water supply line system. s 12500. Floors, Walls, Ceilings, Etc. The floors, walls, ceiling, partitions, posts, doors, and other parts of all preparation and processing areas shall be of such materials, construction and finish that they may be readily and thoroughly cleaned. The floors in all areas where water is used in the operation are to be so constructed and of such material as to be water tight and they shall be maintained in such condition as to stay water tight. All areas used for edible products shall be separate and distinct from those used for inedible products, such as fish meal reduction plants. s 12505. Use of Poisonous Insecticides and Rodenticides in Food Processing Establishments. (a) Every practical precaution shall be taken to keep establishments free from flies, rats, mice and other vermin. If necessary, rodent-proof rooms shall be provided for materials which might become contaminated by these pests. (b) The use of insecticides or rodenticides, toxic to humans, in areas where any food product, not adequately protected, is being stored or handled is prohibited. (c) Poisonous insecticides and rodenticides may be used under buildings, wharves, outbuildings, or similar places, or where adequately protected packaged products are stored; only, if adequate precautions are taken to eliminate the possibility of said poisons being accidentally spilled, or carried, by any means, to areas where these poisons are prohibited. These poisons are to be adequately protected from possible contact by children, or domestic animals, and are to be plainly and distinctly labeled for identification by adults. s 12510. Animals in Plant. Every practical precaution shall be taken to exclude dogs, cats, birds, or other animals and fowl from food establishments. s 12515. Sanitary Facilities. Adequate sanitary facilities and accommodations shall be furnished by every food packing establishment. Of these, the following are specifically required: (a) Dressing rooms, and toilet and urinal rooms shall be sufficient in number and conveniently located. These rooms shall be well lighted, sufficiently ventilated to insure sanitary conditions, vented to the outside, and meet all requirements as to sanitary construction and equipment. All doors entering such rooms shall be self-closing. All windows shall be screened. Such rooms shall be separate from areas in which food products are prepared, stored, or handled. The walls, ceilings, partitions, and other parts of all dressing rooms, toilet rooms, lavatory rooms and urinal rooms shall be of light color and of such construction as to be easily and adequately cleaned. Where five or more persons of both sexes are employed, separate facilities shall be provided for each sex. (b) Sanitary washing facilities, including running hot and cold water, soap, and individual towels, shall be provided, and shall be placed in or near toilet and urinal rooms and also at other places in the establishment as may be essential to insure cleanliness of all persons handling any food product. (c) Adequate lockers or cloak rooms for all employees shall be provided and shall be kept clean and well ventilated. (d) Toilet soil lines shall be kept separate from industrial waste lines to a point outside the buildings. Drainage from toilet bowls and urinal shall not be discharged into grease salvage basins, or into open disposal systems. s 12520. Areas, Equipment, and Operations to Be Sanitary. (a) Areas, equipment, and utensils used for preparing, storing or otherwise handling any food product and all other parts of the establishment shall be kept clean and in sanitary condition. Areas in which any food product is prepared, processed, stored or handled, including walls, ceilings, and overhead structures of such areas shall be kept as reasonably free from moisture as is practicable. In such areas there shall be no drippings from any source including ceilings and overhead structures that may contaminate the product. (b) Equipment and utensils used for preparing, processing, or otherwise handling any food product shall be of such materials and construction that they can be readily and thoroughly cleaned. Pipe lines used to convey fluid or semifluid products shall be so constructed that they can be readily and thoroughly cleaned. (c) Operations and procedures involving the preparation, storing, or handling of any food product shall be strictly in accord with good sanitary practice. s 12525. Personal Hygiene. (a) The employees of the establishment who handle any food product shall keep their hands clean and, after visiting the toilet room or urinals, shall wash their hands before handling any food product or implement used in the preparation of the product. (b) Outer clothing and gloves worn by persons who handle any food product shall be clean and of material that can be readily cleaned. (c) Such practices as spitting on the floor and using empty cans, jars, or other containers as drinking cups, or for purposes other than those originally intended, are forbidden. (d) Care shall be taken to prevent the contamination of food products with perspiration, hair, cosmetics, medicaments, and the like. Adequate head coverings must be worn by all men and women, while engaged in the preparation or handling of any food product. (e) Smoking by any person shall not be permitted while preparing or handling any food product or while handling empty cans, jars, lids, barrels, drums or other receptacles used for food products. (f) The use of fingernail polish by any person preparing, processing, or handling any food product without gloves whereby the product might become contaminated, is prohibited. (g) No clothing, shoes, boots, aprons, etc. shall be kept or stored in any area where any food product is prepared, processed, or handled, except in or on facilities specifically provided for this purpose. s 12530. Surroundings. The outer premises of every food handling establishment embracing docks, storage areas, and areas where cars and vehicles are loaded and unloaded, and the driveways, approaches, yards, etc. shall be properly drained and kept in a clean and orderly condition. The accumulation of any material in which flies or other insects or vermin may breed or which will afford rodent harborage is forbidden. No nuisance which might contribute to insanitation shall be allowed on the premises of any food packing establishment. s 12535. Employment of Diseased Persons. No food packing establishment shall knowingly employ in any department where any food product is prepared or handled, any person affected with a communicable disease. s 12540. Empty Container Storage. Empty cans, jars, covers, lids, barrels, drums, etc. must be clean when filled with food products. s 12545. Tagging Insanitary Equipment. When the use of any equipment, which is unclean or insanitary, would lead to contamination of the food product, an inspector may attach a quarantine tag to it. No equipment or utensils so tagged shall again be used until made acceptable. Such tag so placed shall not be removed by any person other than an employee of the Department of Public Health. s 12550. Recanning. It is not permissible to recan for sale any low acid canned food product for which the State Board of Public Health requires a specific retort process, without first obtaining written permission from the Department of Public Health. Such recanning must be done under the supervision of a duly authorized Inspector of the Department of Public Health. s 12555. Reporting Spoilage. Spoilage in any canned products packed under inspection must be reported in writing to the nearest office of the Department of Public Health, or to any Cannery Inspector in person. All swells, springers and flippers found in the warehouse must be included in the report. s 12560. Segregation. When swells or other evidence of spoilage in excess of one-half of one percent, (5 cans per 1,000), are found in any warehouse lot, such spoilage must be segregated from the normal cans, and the entire lot, including flat cans, held pending immediate notification of the Department of Public Health. No samples of such material shall be drawn for any purpose until authorization has been granted by the Department of Public Health. s 12565. Examination. All of the above must be held in a safe and separate place in the warehouse pending examination and recommendation by a representative of the Department of Public Health as to the disposition thereof. s 12570. Monthly Reports. s 12575. Sale to Salvage Company. A report must be made to the Department of Public Health before any canned products packed under the supervision of the Department of Public Health are sold to a salvage company. The material must be inspected and released by a representative of the Department of Public Health before the shipment is made. s 12580. Application. This regulation is applicable only to warehouse stocks of low acid canned foods which are packed under supervision of the Department of Public Health, and does not apply to material from the cook room damaged or spoiled because of mechanical defects. s 12585. Venting of Canned Food Products. It is not permissible to vent and reprocess for sale any low acid canned food for which the State Board of Public Health requires a specified retort process. s 12590. Tolerance per Batch. (a) Wherein 10 percent or more of a particular batch is found to be in buckled condition, the entire batch (both buckled and normal appearing cans) shall be restrained. Note: By "buckled condition" is meant those cans with strained ends caused by excessive internal pressure during processing or cooling, resulting in one or both ends having elevated or wavy areas such that they have become unsatisfactory for retail trade. (b) Batches wherein less than 10 percent of the number of cans are buckled, only that material showing buckled condition shall be restrained and the normal appearing cans may be released. (c) Buckled cans shall be reformed as soon as possible after the cans have been restrained. The reforming of the cans must be done before any arrangements can be made to submit the material to a flip vacuum test. Note: The reforming consists of forcing the distorted top or bottom back to its normal position. Ends slightly distorted may be reformed by thumb pressure whereas ends more severely distorted or strained may be reformed with the closing machine chuck or other suitable tool. Reforming the ends might have some effect upon the vacuum of the cans and as a consequence flip testing should not follow the reforming operation until approximately 30 days have elapsed. (d) If swells develop during the holding period, they are not to be destroyed, but submitted to the laboratory for examination. s 12595. Supervision of Flip Testing. Flip testing shall be done in the presence of a State Cannery Inspector. Workable zero, or the minimum external vacuum is to be at such a point that cans with 1 1/2 " internal vacuum, or more, are segregated from cans with less than 1 1/2 " internal vacuum. s 12600. Segregation of Flip-Tested Cans. The segregation of flip-tested cans shall be into three lots, namely: (a) Normal appearing cans (b) Cans showing 1 1/2 " or more internal vacuum (c) Cans showing less than 1 1/2 " internal vacuum (1) All swells which do not show obvious cause of spoilage shall be submitted to the laboratory for examination immediately upon instructions from the State Cannery Inspector. (2) All leaks and cans punctured at the time of flip test shall be destroyed. s 12605. Holding After Flip Test. All material, including normal appearing and buckled cans, not destroyed or submitted to the laboratory must remain under the original restraining order until official release has been authorized in writing. (a) Such restrained material shall be segregated and marked to distinguish: (1) normal appearing cans, (2) cans with 1 1/2 " or more internal vacuum, (3) cans with less than 1 1/2 " internal vacuum. s 12610. Cans Having Less Than 1 1/2 " Internal Vacuum. After the flip test representative samples of cans having less than 1 1/2 " internal vacuum shall be submitted for laboratory examination. (a) If laboratory findings on samples containing less than 1 1/2 " internal vacuum indicate no spoilage, the remainder of the cans in the batch restrained containing less than 1 1/2 " vacuum may be released for manufacturing purposes or disposed of directly through channels such as hotels or restaurants for immediate consumption. The canner must notify the Department of Public Health to whom this lot is sold. The material flip testing 1 1/2 " or more vacuum and the normal cans may be released for retail trade. (b) If laboratory findings on samples containing less than 1 1/2 " internal vacuum indicate the product not to be commercially sterile, all such cans are to be destroyed in the presence of the State Cannery Inspector. s 12615. Cans Having 1 1/2 " or More Internal Vacuum. In the event no cans in the lot are found with internal vacuum less than 1 1/2," representative samples of the lot having 1 1/2 " or more of internal vacuum shall be submitted for laboratory examination. (a) If laboratory findings on samples containing 1 1/2 " or more internal vacuum indicate no spoilage, the remainder of the cans having flip tested 1 1/2 " or more internal vacuum may be released for retail distribution. Normal cans restrained in such lots may also then be released for shipment through retail trade channels. (b) If laboratory findings on samples having 1 1/2 " or more internal vacuum indicate the product not to be commercially sterile, all such cans shall be destroyed in the presence of the State Cannery Inspector. In this event, samples will then be taken from the lot of normal appearing cans to be submitted for laboratory examination. s 12620. Normal Cans; No Spoilage. If laboratory findings on samples of normal appearing cans indicate no spoilage, the remainder of the normal appearing cans may then be released for retail trade distribution. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Sections 28432 and 28440, Health and Safety Code. s 12625. Normal Cans; Spoilage. If laboratory findings on samples of normal appearing cans indicate the product not to be commercially sterile, all such cans are to be destroyed in the presence of the State Cannery Inspector. s 12630. Overfills and Hydrogen Swells. That material found to be abnormal due to overfilling or due to the accumulation of hydrogen from chemical action may be recanned under the inspection of the Department of Public Health, based on laboratory examinations of representative samples. See Sections 12550 and 12585 of these regulations. s 12635. Sampling. All samples submitted to the laboratory must be selected by the State Cannery Inspector. s 12640. Decision to Flip Test. The Department of Public Health shall determine for each restrained lot whether both normal appearing cans and buckled cans must be flip tested. s 12645. Prevention of Salvage of Unfit Canned Foods. All unfit food products in hermetically sealed containers that are destroyed in public or private dumps must be destroyed by any method suitable to the Department of Public Health; thus preventing the salvage of food unfit for human consumption. s 12650. Applications. Applications must be made to the Department of Public Health, in writing, for permission to put up experimental trial packs of any low acid food products. Applications must include complete details of the prospective pack: formula, product, size of pack, size of cans, number of cans, packing medium, initial temperature, time and temperature of process, pH of pack, processing equipment, proposed labels, proposed use of the finished pack. Experimental packs not so authorized will be restrained. s 12652. Exemption. The above does not apply to a commercial cannery equipped with or having access to a qualified research department if no commodities packed on an experimental basis will be distributed in commerce. s 12655. General Rules. (a) The term "decomposed" as used herein shall mean fish that are "in whole or in part diseased, contaminated, filthy, putrid, or decomposed or otherwise unfit for food." (b) The Department of Public Health shall require the seller of raw fish and the canning organization involved in each sale to comply with the provisions of Chapter 3 of Division 21 of the Health and Safety Code prohibiting the manufacture, production, preparation, compounding, packing, selling, offering for sale or keeping for sale of any decomposed fish. The responsibility for maintaining an effective inspection service and of eliminating decomposed fish from the canned product shall rest upon the Department of Public Health, Bureau of Food and Drug Inspections, and the executive head of each canning organization. (c) The inspector in charge at the plant shall require that all cannery operations be carried on under clean and sanitary conditions and require the immediate disposal of decomposed fish, fish offal and bait chum. (d) The term "inspector" as used in these regulations shall mean a duly authorized "state cannery inspector." s 12660. Standards for Inspection of Raw Fish. (a) Inspection of raw fish shall be strict and uniform and shall be designed and carried out to the end that fish unsuitable for canning shall be rejected in the raw state insofar as possible. (b) The standards to be used in the examination and judging of fish shall be such as will make the resultant product conform to the Food, Drug and Cosmetic Act of the United States and to the California Health and Safety Code, Chapter 3 of Division 21. (c) The Department of Public Health shall reject fish only if decomposed or unfit for human consumption. Note: The Department will not reject cooked fish because of its color or quality, unless such color or quality indicates decomposition as defined in subsection (a) hereof. (d) Split, mashed, or broken fish shall be condemned if deemed by the inspector to be necessary for the prevention of acceptance of decomposed fish. (e) The canner shall, promptly on arrival of each boat-load of fish, notify the Department of Public Health, and no canner shall receive fish into its plant until authorization is given by the inspector. (f) Raw tuna in the round, shall be inspected by the examination of each raw, defrosted fish at the time they are eviscerated. "Defrosted" shall mean that each fish is thawed out to the point that odors are readily detectable. Raw tuna, not in the round, received dressed, eviscerated, gilled, headed or loins or pieces received frozen, shall be inspected in a manner satisfactory to the Department of Public Health at such places and times as may be directed by the inspector to prevent the canning of decomposed fish. Cooked fish, frozen cooked fish or fish pieces, shall be inspected at such places and times as may be directed by the inspector to insure compliance with the law and these regulations. (g) Raw sardines and mackerel shall, when offered for delivery, be inspected in the boat or at the hoist or at any other point selected by the inspector in charge of the district in order to insure the most effective inspection at each plant. There may be more than one place of inspection. s 12665. Inspection Service -Tuna. (a) The inspection of all fish for canning purposes shall be under the direction of the Chief of the Bureau of Food and Drug Inspections of the Department of Public Health. The inspector on duty at each plant shall observe that all operations are carried out in a sanitary manner and in a manner to prevent the canning of decomposed fish, and shall immediately report to his superior any unusual or objectionable practice. (b) In order to facilitate and expedite the administration and enforcement of the aforementioned acts and these regulations each canner may select sufficient personnel from his own employees who shall be trained by an inspector of the bureau to examine fish. The supervising inspector shall notify each canner in writing the names of employees of each company who are approved by the bureau as fish examiners. (c) The detailed examination of the fish shall be made by an inspector or an approved cannery fish examiner under the supervision of an inspector. The inspector shall specify the number of cannery fish examiners required, in accordance with the condition of fish in process from time to time, and the canner immediately shall supply the number so specified, referring any difference of opinion in this regard to the inspector in charge of the district. The approved cannery fish examiners shall at all times be under the direction of the inspector in charge at the plant while they are performing the duty of examining fish. The inspector in charge at the plant may call upon the cannery management for an approved substitute whenever any authorized cannery fish examiner is, in the opinion of the inspector, doing his work unsatisfactorily. In the event such substitution is not immediately made, an inspector shall be assigned to replace him until an approved substitute is available. The canner involved shall not receive or pack any fish until a proper substitute or an inspector is available. All costs shall be assessed against the canner involved. (d) The inspector in charge of the district shall have full authority over the activities of his subordinates while assigned to the respective canneries. s 12670. Raw Fish Reports. (a) The inspector shall make a written record of each boat load on a printed form. The records shall state total quantity of fish and include such evidence as the inspector may be able to obtain as to the method of handling. (b) The bureau shall have free access to the records of each cannery which bear directly on the problem of fish and cannery inspection. (c) Condemned tuna shall be weighed by the canner in the presence of the inspector and the inspector's report shall show accurately the weight of condemned fish. The inspector shall keep separate weight records of fish rejected by the canner because of quality or condition other than decomposition. s 12675. Fishing Vessels. (a) Decks and holds of all boats and vessels catching tuna, mackerel, or sardines and transporting them to a cannery shall be kept in a clean and sanitary condition. The requirement for cleaning vessels and boats shall be enforced regardless of the size or type of the vessel or boat and shall be uniform throughout the State. (b) Each vessel shall keep a written log which shall be available to the inspection service. Records of net boats shall show the time of each set. (c) No decomposed chum may be used for bait or in taking mackerel. All bait or chum used must be fresh (not over 24 hours old) unless it be salted or frozen. (d) High seas fishing boats, whether net or bait, shall keep a record of their catch and their methods of handling fish, including hold and water temperature. (e) The Department of Public Health or its authorized agent may require interested parties, including members of the laboratory staff, to appear when undue quantities of fish have been condemned. Inquiry shall be made of the fishermen to determine the methods used in fishing and handling. An endeavor shall be made to explain to the fishermen the proper method of handling raw fish to prevent the recurrence of the loss. Representatives of the United States Food and Drug Administration and other interested parties may be admitted to the inquiry. s 12680. Disposal of Condemned Fish. (a) When a boat load of tuna or mackerel has been condemned as unfit for canning, the inspector shall notify the supervising inspector who shall take such action as is necessary to prevent delivery of the rejected fish to any other plant. (b) When a boat load of sardines has been condemned and the canner to whom delivery was offered can not receive the fish for reduction purposes, the inspector shall take the necessary steps to prevent the canning of these fish by any other canner. (c) In all cases the inspector shall serve notice upon the captain of the boat whose fish are condemned that they shall not be used or sold for canning purposes. (d) The inspector shall take such action as may be necessary to insure that fish which are condemned for canning purposes shall not be used for canning. s 12685. Sampling Canned Tuna. (a) The supervising cannery inspector in charge of the district shall determine whether or not sample cans of the final product shall be taken for examination. He shall base his decision upon the condition of the boat load and the report of the inspector. If the boat load of fish is in a prime state of preservation at the time of packing, confirmed by inspection in the plant, no samples need be taken. (b) Sampling shall be carried out according to rules promulgated by the Department of Public Health and the minimum quantities of samples shall be as follows: A lot of less than 200 cases.... 48 cans 200 to 1,000 cases.............. 96 cans 1,000 to 2,000 cases............ 192 cans 2,000 to 5,000 cases............ 288 cans 5,000 to 10,000 cases........... 576 cans Over 10,000 cases............... 960 cans Not more than one can should be taken from any one case in sampling. s 12690. Horse Mackerel. ( Treacherous symmetricus) may be labeled as "Jack mackerel" providing that the word "jack" shall be prominently printed in the same size, style and color letters as the word "mackerel" which it modifies; and in addition, that the scientific name Treacherous symmetricus be included on the label; also no written or oral representation on the label or in connection with the sale of the product in invoicing or elsewhere implying that this fish is California mackerel or Pacific mackerel ( Pneumatophorus diego) or any fish other than Treacherous symmetricus. s 12695. Sanitary Boat Certificates. s 12700. Supervision of Cleaning. s 12705. Method of Cleaning. s 12710. Application. Any packer desiring to use the inspection legend on labels for products packed under the provisions of Chapter 8 of Division 21 of the Health and Safety Code shall make a formal written application therefor to the Board of Public Health. s 12715. Permission. Upon receipt of written permission from the Board of Public Health the following statement may be placed on the labels of only those products packed in compliance with the provisions of the Laws Relating to Cannery Inspection. s 12720. Official Wording. The official wording of the legend is as follows: Sterilized under the supervision of and according to the regulations of the California State Department of Public Health. s 12725. Notification of Intention to Install Retorts. Every person, firm, company, organization, association, or corporation in the State of California desiring to install a retort to be used for the sterilization of low-acid food products in accordance with the provisions of Sections 28410 and 28411 of the Health and Safety Code, prior to installation of such equipment, shall notify the Department of Public Health. s 12730. Obtaining Approval. Approval shall be obtained from the Department of Public Health before any retort equipment is installed or before previously installed equipment may be used for processing commercial products under inspection. Note: Upon request diagrams of minimum installations for discontinuous retorts may be obtained from the Department of Public Health. s 12735. Types of Retorts. (a) Horizontal. Still and rotary retorts (b) Vertical. Still retorts (c) Continuous. Pressure cookers Installations and operations of continuous pressure cookers are not sufficiently standardized at the present time to permit making regulations governing their installations and operation. However, such installations shall be subject to the approval of the Department of Public Health. s 12740. Definition of Terms. (a) Inspector. "Inspector" means a duly authorized representative of the Department. (b) Vent. A "vent" is a valve-controlled opening into a retort, used for the elimination of air during the coming-up time. (c) Retort Bleeder. A "retort bleeder" is an opening of at least one-eighth inch into a retort which is open during the entire process for the removal of air that may enter the retort with the steam or through a leaky air valve. (d) Thermometer Bleeder. A "thermometer bleeder" is a one-sixteenth inch or larger opening into a thermometer well or pocket. This bleeder is open during the entire process to ensure a continuous flow of steam from the retort past the thermometer bulb in order that the temperature shown will be the same as that in the retort. (e) Coming-Up Time (Lag). The "coming-up time" is the time which elapses between the turning on of the steam and the time when the retort reaches the processing temperature. (f) Process. The term "process" designates the heat treatment expressed in terms of temperature and time given the product after the container is permanently sealed, in order to destroy spoilage microorganisms. (g) Plug-Cock Valves. An approved type of "plug-cock valve" is one which permits an unrestricted flow of air through the valve. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 12745. Required Equipment for All Types of Retorts When Sterilizing Food in Tin or in Glass Jars with Closures Such That They May Be Processed in Steam. (a) Recording Thermometer. (1) The temperature chart shall be easily readable to 1 degree F and shall be graduated in not to exceed 2 degrees F divisions within the range of plus and minus 10 degrees F of the official process to be used. All charts shall have a working scale of not less than three inches. Written permission from the Department shall be obtained for the use of old equipment with charts having a working scale of less than three inches. All replacements or new installations shall conform to a minimum three-inch working scale. (2) No temperature chart shall be used in a recording thermometer unless it is a chart manufactured specifically for use in the recording thermometer installed on the retort. (3) It shall be unlawful to use charts with the temperature indicated in code. (4) Every recording thermometer shall bear the name plate of the original manufacturer having the serial number assigned by the manufacturer, and the manufacturer's chart number die stamped thereon. (5) Any recording thermometer found by a cannery employee or Inspector to be faulty in its operation shall be promptly adjusted or replaced by a properly functioning instrument. (6) Any recording thermometer requiring repair of the thermal system shall be repaired by the manufacturer or a servicing organization accredited by the manufacturer. (7) Documentary evidence of proper calibration may be required for any repaired recording thermometer when returned by the manufacturer or accredited servicing organization. (8) All recording thermometers shall be so placed with respect to light that they are conveniently readable. (b) Indicating Mercury Thermometer. (1) The divisions shall be easily readable to 1 degree F and shall not exceed 20 degrees F per inch of graduated scale. It shall be unlawful to use mercury thermometers with the temperatures indicated in code. (2) All mercury thermometers shall be placed in respect to light so that they are conveniently readable. (c) Pressure Gauge. (1) Every retort shall have a pressure gauge of the Bourdon type in which the operating mechanism is a complete unit independent of the case. Every gauge shall be equipped with a compensating hair spring. (2) The minimum diameter of the dial shall be four inches. (3) The range of the pressure scale shall preferably be 0 to 30 pounds, but a range of 0 to 60 pounds may be used. (4) Any retort pressure gauge found to be inaccurate either by a cannery employee or by an Inspector shall be replaced by a properly functioning instrument. (d) Valves for Removal of Condensate. (1) Condensate shall not be allowed to accumulate in horizontal retorts. Note: This may be prevented by the installation of a one-half inch or larger valve in the bottom of the retort to be left open sufficiently to remove the condensate. (2) To assure that condensate will not accumulate in a retort during the process, a one-eighth inch or larger petcock or valve shall be installed or a hole drilled in the drain or bottom of the retort and it shall remain open during the entire processing time. (e) By-Pass Around Diaphragm Control Valve on Steam Inlet. Each diaphragm control valve shall be equipped with a by-pass to allow for hand control in case of an emergency. (f) Steam Inlet. (1) Horizontal Retorts: (A) For retorts more than 20 feet in length, the steam shall enter the spreader pipe near the center of the retort. For retorts less than 20 feet in length, the steam may enter the spreader pipe either at the center or at the end. If steam enters at the end, the spreader pipe shall be no smaller than the steam inlet. (B) The retort shall be equipped with an adequately perforated pipe extending throughout the entire length of the bottom of the retort with perforations arranged so that the steam is directed up and into the load of cans. The ends of the steam spreader shall be closed. (2) Vertical Retorts: (A) If steam is admitted into the bottom of the retort, it shall be directed up into the load of cans. Any other position of the steam inlet must be approved by the department. Note: The recommended number of holes to be used in steam spreaders is given in the following table: _____________________________________________ Size of Steam Supply Inlet Size 3/4 1 1 1/4 1 1/2 2 2 1/2 Holes Inch Inch Inch Inch Inch Inch Inches Pipe Pipe Pipe Pipe Pipe Pipe 3/16 25 45 70 112 185 265 7/32 18 35 50 82 135 195 1/4 14 25 38 62 105 145 _____________________________________________ (g) Retort Bleeders. (1) For Horizontal Retort: (A) A horizontal retort shall be equipped with bleeders along the top of the retort not more than eight feet apart and there shall be one within approximately one foot of each end of the retort. These bleeders shall be kept wide open during the entire process. (B) Any bleeder at least one-eighth inch in size on a thermometer well may be considered to comply with this requirement when the well is in the top of the retort and located at the proper place. (2) For Vertical Retort: (A) A vertical retort shall be equipped with a bleeder at the end of the retort opposite the steam inlet. This bleeder shall be wide open during the entire process. In the case of very small retorts (less than 30-inch diameter and less than four feet in depth) a three-thirty-second inch bleeder may be used. (h) Thermometer Bleeders. Bleeders for All Thermometers on All Types of Retorts. A one-sixteenth-inch or larger bleeder hole shall be kept open for the free escape of steam on all thermometer fittings unless thermometer bulbs are set wholly within the shell of retort proper. The bleeders shall be so located as to provide a full flow of steam past the sensitive part of the thermometer bulb. (i) Vents for Removal of Air From Retorts During Coming-Up Period. Vents shall be installed and operated in such a way that all the air is removed from the retort before timing of the process is started. Note: See the venting systems described under Sections 12760 and 12765 of these regulations. (j) Stacking Equipment for Use in Horizontal and Vertical Retorts. (1) Stacking equipment (baskets, trays, gondolas, etc.) for all types of containers in discontinuous retorts, when cans or jars are stacked in a vertical position, shall be preferably of strap iron. When perforated sheet metal baskets are used, the perforations in the bottoms shall be at least one-inch holes on one-and-three-fourths-inch centers or their equivalent, unless other equipment has been approved. (2) If dividers are used, they shall be of wide mesh material, such as fish nets or onion sacks, or of strap iron or sheet metal having perforations at least the equivalent of one-inch holes on one-and-three-fourths-inch centers. Close meshed cloth dividers are not permitted. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28411, Health and Safety Code. s 12750. Additional Equipment Suggested but Not Required by the Department of Public Health. (a) The use of an additional thermometer on each retort is advised to serve primarily as a check instrument, preferably located adjacent to the temperature recorder bulb. (b) An automatic temperature controller is recommended. (c) A safety valve of such size and capacity that it meets with the requirements of any board of mechanical engineers or any safety code in the State of California, and/or the California Industrial Accident Commission. It is recommended that the safety valve discharge be equal to or greater in capacity, than the retort steam supply line. s 12755. Venting of Retorts for Removal of Air, General Considerations. (a) Vents (except drains when used as vents) shall be in the opposite side or end of the retort from that at which the steam is admitted. (b) Vent valves shall be of the gate or plug cock type, preferably quick acting, except where otherwise specified. Note: A globe valve of one pipe size larger than the minimum vent requirement may be substituted for a gate valve. (c) for the most efficient operation of a retort, cans shall be so stacked, and the stacking equipment shall be of a type such that the air can be removed rapidly enough to permit a uniform distribution of heat throughout the retort at the time processing temperature is attained. Anything which interferes with the free flow of steam through any part of a retort load makes this requirement more difficult to meet. Note: Use of the drain as a vent in conjunction with venting from the top of the retort is permissible and several combinations of top and bottom vents are described. However, it is more desirable to use venting systems which do not involve the use of the drain. Various arrangements of vents may be used to obtain uniform heat distribution throughout a retort. The following vent arrangements and cycles of operation have been found to give satisfactory heat distribution. Every retort shall be equipped with one of these installations or some other arrangement of vents which is equally satisfactory. If venting systems other than those described here are desired, or if shorter coming-up times are to be used, the approval of the Department of Public Health shall first be obtained. A special investigation may be required in order to determine the conditions under which such equipment may be used. If equipment now in use approximates, but does not exactly conform to one of the prescribed venting systems, the Department of Public Health should be consulted before any expensive change of equipment is undertaken. Full details concerning the present installation should be furnished to the department. Conditions such as boiler capacity and size of steam inlets vary in different plants and modifications of the venting procedure may be necessary in some instances to permit reaching the temperature specified within the recommended time. When this seems necessary, an investigation will be made by the Department of Public Health and modifications of the equipment or venting procedure will be suggested in accordance with conditions found. When a change in procedure is suggested, this new procedure will then become the approved method of venting the retorts in question at that plant. s 12760. Venting of Horizontal Retorts for Removal of Air. Note: The following venting specifications are for discontinuous horizontal retorts not exceeding five and one-half feet inside diameter, and are based on data from tests made with round cans in strap iron trays. There is evidence to indicate that the use of perforated sheet metal trays may necessitate supplementary retort venting or modifications in the stacking of cans. (a) System A. Venting Through Multiple One-Inch Vents Discharging Directly to the Atmosphere. (1) Equipment. A retort shall be equipped with unrestricted one-inch pipes approximately one foot in length, one for each five feet -or fraction thereof - of retort length, approximately symmetrically placed along the top of the shell, uniformly separated and not more than seven feet apart. There shall be one of the above vents within two and one-half feet of each end of the shell. (2) Operation. The vent valve shall be wide open when steam is admitted to the retort, and shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 225 degrees F, or at least seven minutes to at least 220 degrees F. (3) If vent pipes are to be extended beyond the valves, the extensions shall be of at least one pipe size larger than the vent pipes entering the retort. (b) System B. Venting Through the Drain Valve and Through Multiple One-Inch Vents Discharging Directly to the Atmosphere. (1) Equipment. A retort shall be equipped with unrestricted one-inch pipes approximately one foot in length, one for each five feet -or fraction thereof - of retort length, approximately symmetrically placed along the top of the shell, uniformly separated and not more than seven feet apart. There shall be one of the above vents within two and one-half feet of each end of the shell. (2) In addition, the retort shall be equipped with a drain of not less than three-inch pipe size for retorts up to 15 feet in length or of not less than four-inch pipe size for retorts over 15 feet in length. Note: The drain valve may be either globe or gate type. (3) Operation. The vent valves and the drain valve shall be wide open when steam is admitted to the retort. (4) The drain valve shall remain wide open for at least two minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 210 degrees F. (5) The one-inch vent valves shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F. (6) If vent pipes are to be extended beyond the valves, the extensions shall be of at least one pipe size larger than the vent pipes entering the retort. Note: The drain may be extended beyond the valve with pipe the same size as the valve. (c) System C. Venting Through Multiple One-Inch Vents Discharging Through a Manifold. (1) Equipment. A retort shall be equipped with unrestricted one-inch pipes, approximately one foot in length, one for each five feet -or fraction thereof - of retort length, approximately symmetrically placed along the top of the shell, uniformly separated, not more than seven feet apart, and connected into a manifold. There shall be one of the above vents within two and one-half feet of each end of the shell. The manifold shall be of 2 1/2 -inch pipe size for retorts up to 15 feet in length, and of three-inch pipe size for retorts over 15 feet in length. Venting shall be controlled by a vent valve in a pipe leading from, and of a size not smaller than that of the manifold. (2) Operation. The vent valve shall be wide open when steam is admitted to the retort, and shall remain wide open for at least six minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 225 degrees F or at least eight minutes to at least 220 degrees F. (3) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired. (d) System D. Venting Through the Drain Valve and Through Multiple One-Inch Vents Discharging Through a Manifold. (1) Equipment. A retort shall be equipped with unrestricted one-inch pipes approximately one foot in length, one for each five feet -or fraction thereof - of retort length, approximately symmetrically placed along the top of the shell, uniformly separated, not more than seven feet apart and connected into a manifold. There shall be one of the above vents within two and one-half feet of each end of the shell. The manifold shall be of 2 1/2 -inch pipe size for retorts up to 15 feet in length, and of three-inch pipe size for retorts over 15 feet in length. Venting shall be controlled by a vent valve in a pipe leading from, and of a size not smaller than that of the manifold. (2) In addition, the retort shall be equipped with a drain of not less than three-inch pipe size or retorts up to 15 feet in length or of not less than four-inch pipe size for retorts over 15 feet in length. Note: The drain valves may be either gate or globe type. (3) Operation. The vent valve and drain valve shall be wide open when steam is admitted to the retort. (4) The drain valve shall remain wide open for at least three minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 210 degrees F. (5) The vent valve shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F. (6) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired. (e) System E. Venting Through the Water Spreader. (1) Equipment. The water spreader shall be of not less than 1 1/2 -inch pipe size for retorts less than 15 feet in length, with the water inlet connected through the shell so that the spreader pipes extend in both directions from a tee in the water inlet. The water inlet to which the spreader is connected shall be of not less than two-inch pipe size. The vent pipe shall be of at least two-inch pipe size and shall be connected into the water inlet without any restriction in pipe size. The water spreader shall be of not less than two-inch pipe size for retorts from 15 to 30 feet in length with the water inlet connected through the shell so that the spreader pipes extend in both directions from a tee in the water inlet. The water inlet to which the spreader is connected shall be of not less than 2 1/2 -inch pipe size. The vent pipe shall be of at least 2 1/2 -inch pipe size and shall be connected into the water inlet without any restrictions in pipe size. If the water enters at or near one end of the retort the water spreader shall be at least as large as the water inlet. For retorts over 30 feet in length, the Bureau of Food and Drug Inspections, Cannery Inspection Section, shall be consulted for the proper venting requirements. (2) The water spreader shall have holes of not less than three-sixteenths-inch diameter distributed uniformly along the length of the spreader pipe, and of sufficient number so that their aggregate area is not less than that of a two-inch pipe (3.34 square inches) for retorts up to 15 feet in length, or not less than that of a 2 1/2 -inch pipe (4.75 square inches) for retorts having lengths of 15 to 30 feet. (3) Operation. The vent valve shall be wide open when steam is admitted to the retort, and shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 225 degrees F; or the vent valve shall remain wide open for at least seven minutes to at least 220 degrees F. (4) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired. (5) The following table indicates the minimum number of holes permissible in water spreaders when used for venting: Number of Holes in Spreader Pipe Drill For 1 1/2-Inch For 2-Inch For 2 1/2-Inch Size Pipe Outlet Pipe Outlet Pipe Outlet Inches (2.02 Sq. In.) (3.34 Sq. In.) (4.75 Sq. In.) 3/16 74 121 173 7/3 54 89 127 1/4 42 69 97 (f) System F. Venting Through the Drain Valve and Through the Water Spreader. (1) Equipment. The water spreader shall be of not less than 1 1/2 -inch pipe size for retorts less than 15 feet in length, with the water inlet connected through the shell so that the spreader pipe extends in both directions from a tee in the water inlet. The water inlet to which the spreader is connected shall be of not less than two-inch pipe size. The vent pipe shall be of at least two-inch pipe size and shall be connected into the water inlet without any restriction in pipe size. The water spreader shall be of not less then two-inch pipe size for retorts from 15 feet to 30 feet in length with the water inlet connected through the shell so that the spreader pipe extends in both directions from a tee in the water inlet. The water inlet to which the spreader is connected shall be of not less than 2 1/2 -inch pipe size. The vent pipe shall be of at least 2 1/2 -inch pipe size and shall be connected into the water inlet without any restrictions in pipe size. If the water enters at or near one end of the retort the water spreader shall be of at least the same size as the water inlet. For retorts over 30 feet in length, the Department of Public Health shall be consulted for the proper venting requirements. (2) The water spreader shall have holes of not less than three-sixteenths-inch diameter distributed uniformly along the length of the spreader pipe, and of sufficient number so that their aggregate area is not less than that of two-inch pipe (3.34 square inches) for retorts up to 15 feet in length, or not less than that of a 2 1/2 -inch pipe (4.75 square inches) for retorts having lengths of 15 to 30 feet. Note: See table in subsection (e)(5) for number and size of holes required. (3) In addition, the retort shall be equipped with a drain of not less than three-inch pipe size for retorts up to 15 feet in length or of not less than four-inch pipe size for retorts over 15 feet in length. The drain valve may be either globe or gate type. (4) Operation. The vent valve and the drain valve shall be wide open when steam is admitted to the retort. (5) The drain valve shall remain wide open for at least two minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 210 degrees F. (6) The vent valve shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F. (7) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired. (g) System G. Venting Through a Single 2 1/2 -Inch Top Center Vent -for Retorts Less Than 15 Feet Long. (1) Venting may be accomplished by the use of a single 2 1/2 -inch unrestricted vent located at the top of the shell, provided this vent is within two feet of the center of the retort. (2) Operation. The vent valve shall be wide open when steam is admitted to the retort, and shall remain wide open for at least four minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F. If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired. (h) System H. Venting Through the Drain Valve and Through a Single 1 1/2 -Inch Top Center Vent for Retorts Less Than 15 Feet Long. (1) Venting may be accomplished by the use of the drain valve in conjunction with a single unrestricted 1 1/2 -inch vent located at the top of the shell, provided the vent is within two feet of the center of the retort. (2) In addition, the retort shall be equipped with a drain of not less than four-inch pipe size. (3) Operation. The vent valve and the drain valve shall be wide open when steam is admitted to the retort. (4) The drain valve shall remain wide open for at least two minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 210 degrees F. (5) The vent valve shall remain wide open for at least five minutes after steam is turned on, and until the mercury thermometer on the retort indicates a temperature of at least 220 degrees F. (6) If the vent valve is connected into a discharge pipe or system for removal of steam from the building, the header shall be sufficiently large so that venting will not be impaired. s 12765. Venting of Vertical Retorts for Removal of Air. (a) The following specifications apply for venting vertical retorts not larger than approximately 42 inches diameter by 96 inches high, when the following equipment is used: (1) Strap-iron or adequately perforated metal baskets. (2) Vents located in or near the top of the retort. (3) At least a one-inch steam line into the bottom of the retort and arranged so that steam is directed up into the load of cans. (4) Raised supports for retort baskets so constructed that no baffling effect occurs. Baffle plates are not permitted. If dividers are used, they shall be of wide mesh material, such as fish nets or onion sacks, or of strap iron or sheet metal having perforations at least the equivalent of one-inch holes on one and three-fourths-inch centers. Close meshed cloth dividers are not permitted . (b) System I. Venting Through a Single 1 1/2 -Inch Overflow Pipe. (1) Venting of a vertical retort may be accomplished through a 1 1/2 -inch overflow pipe if it is connected to the retort within at least 10 inches of the top of the shell. The overflow pipe shall have not more than eight feet of 1 1/2 -inch pipe beyond the valve. If the vent pipe discharges into a manifold, the manifold shall be sufficiently large so that venting will not be impaired. (2) Operation. The vent valve shall be wide open when steam is turned on, and it shall remain wide open for at least four minutes after steam is turned on and also until the mercury thermometer reaches a temperature of at least 218 degrees F or for at least five minutes to at least 215 degrees F. (c) System J. Venting Through a Single One-inch Top Vent. (1) Venting of a vertical retort may be accomplished through a single unrestricted one-inch vent located in the lid of the retort. This vent shall be equipped with a one-inch gate valve and shall discharge into the atmosphere, with not more than four feet of one-inch pipe beyond the valve. (2) The vent valve shall be wide open when steam is turned on, and it shall remain wide open for at least five minutes after steam is turned on and also until the mercury thermometer reaches a temperature of at least 230 degrees F or for at least seven minutes to at least 220 degrees F. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28411, Health and Safety Code. s 12767. Diagrams of Venting Systems. Diagrams Reprinted from "Food Industries" Vol. 16, Page 93, February, 1944 Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 12770. Notification of Intention to Install Retorts. Every plant desiring to install a retort to be used for the sterilization of low acid food products in accordance with the provisions of Sections 28410 and 28411 of the Health and Safety Code, prior to installation of such equipment, shall notify the Department of Public Health. s 12775. Obtaining Approval. Approval shall be obtained from the Department of Public Health before any retort equipment is installed, or before previously installed retort equipment may be used for processing commercial products under inspection. Every plant must be properly equipped to satisfy all requirements of the department. s 12780. Equipment Required. Every horizontal steam operated discontinuous retort to be used for the sterilization of food products packed in glass containers must have the following as minimum equipment: (a) Gauge water glass or series of petcock water level indicators. (Gauge water glass is recommended.) Note: Automatic pressure control is recommended to prevent waste of compressed air. (b) Pressure regulating valve in the overflow line. It shall be the same size as, or larger than, the water supply line. (c) Automatic temperature control. (d) Recording thermometer (1) The temperature chart shall be easily readable to 1 degree F and shall be graduated in not to exceed 2 degrees F divisions within the range of plus and minus 10 degrees F of the official process to be used. All charts shall have a working scale of not less than three inches. Written permission from the Department shall be obtained for the use of old equipment with charts having a working scale of less than three inches. All replacements or new installations shall conform to a minimum three-inch working scale. (2) No temperature chart shall be used in a recording thermometer unless it is a chart manufactured specifically for use in the recording thermometer installed on the retort. (3) It shall be unlawful to use charts with temperature indicated in code. (4) Every recording thermometer shall bear the name plate of the original manufacturer having the serial number assigned by the manufacturer, and the manufacturer's chart number die stamped thereon. (5) Any recording thermometer found by a cannery employee or State Cannery Inspector to be faulty in its operation shall be promptly adjusted or replaced by a properly functioning instrument. (6) Any recording thermometer requiring repair of the thermal system shall be repaired by the manufacturer or a servicing organization accredited by the manufacturer. (7) Documentary evidence of proper calibration may be required for any repaired recording thermometer when returned by the manufacturer or accredited servicing organization. (8) All recording thermometers shall be so placed with respect to light that they are conveniently readable. (e) Indicating mercury thermometer. (1) The divisions shall be easily readable to 1 degree F and shall not exceed 20 degrees F. per inch of graduated scale. It shall be unlawful to use mercury thermometers with the temperature indicated in code. (2) All mercury thermometers shall be placed in respect to light so that they are conveniently readable. (f) Pressure gauge. (1) Every retort shall have a pressure gauge of the Bourdon type in which the operating mechanism is a complete unit independent of the case. Every gauge shall be equipped with a compensating hair spring. (2) The minimum diameter of the dial shall be four inches. (3) The range of the pressure scale shall preferably be 0 to 30 pounds but a range of 0 to 60 pounds may be used. (4) Any retort pressure gauge found to be inaccurate either by a cannery employee or by an Inspector shall be replaced by a properly functioning instrument. (g) Proper circulating equipment to insure agitation of the water during come-up and process time. In horizontal retorts this may be accomplished with a recirculating pump. In vertical retorts this may be accomplished by providing for a continuous supply of compressed air through the steam distributor cross during these periods. The bypass line around the air control valve, providing a continuous supply of air, shall be at least one-eighth inch inside diameter. (h) Adequately perforated steam distributor pipe extending the length of horizontal retorts or forming a cross throughout the width of the bottom of vertical retorts or any other approved methods. (i) Bottom drain. (j) A safety valve of such size and capacity that it meets with the requirements of any Board of Mechanical Engineers or any Safety Code in the State of California, and/or the California Industrial Accident Commission. It is recommended that the safety valve discharge be equal to or greater in capacity than the retort steam supply line. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28411, Health and Safety Code. s 12785. Installation of Equipment. (a) The gauge water glass or series of petcocks shall be installed in such a position as to determine the water level during the process. If a gauge water glass is used, a mark indicating the height of the top row of jars shall be placed on the gauge water glass. If a series of petcocks is used, the petcock above the level of the top row of jars must be open at all times during the process and the free flow of water shall be visible to the retort operator. (b) Steam and air shall be admitted at the bottom of the retort. Water may be admitted at the top, or bottom, or both. Note: It is recommended that all pipe connections be equipped with check valves where there is a common entrance for steam, water, and air. (c) Steam and air shall be admitted into the bottom center of the retort through a perforated pipe or cross extending the length of the horizontal retort or throughout the width of a vertical retort, and in which the perforations are so arranged as to produce equal turbulence and distribution throughout the length of the pipe or cross. The extreme ends of the perforated steam distributor pipe or cross shall be closed; other methods of producing turbulence and proper distribution of heat are subject to approval. (d) Each diaphragm control valve shall be equipped with a bypass to allow for hand control in case of an emergency. (e) In horizontal retorts a suction manifold shall be installed in the bottom of the retort to remove the water for circulation. The number of water inlets to the suction manifold shall be dependent upon the length of the retort with a minimum of one for each eight linear feet of retort length. The inlets shall be spaced at approximately equal intervals. The combined area of the inlets shall equal the area of the manifold. The manifold shall be connected to a recirculating pump operating at a sufficient rate to completely recirculate the water in not more than seven minutes. The water shall re-enter the top of the retort through the perforated water spreader. Any other type of manifold or suction installation will be subject to the approval of the Department. Note: It is recommended that the switch operating the pump be equipped with a signal light, preferably red, or other warning device, so that the operator can see at all times that the pump is properly functioning. (f) In horizontal retorts the mercury thermometer bulb, recording thermometer bulb and temperature controller bulb shall be located within the shell of the retort, and in such a position that they are beneath the surface of the water throughout the process. (g) In vertical retorts the recording thermometer bulb and temperature controller bulb shall be installed at the bottom of the retort beneath and away from the steam inlet. (h) In vertical retorts the mercury thermometer shall be so installed as to permit continuous circulation of the heating medium past the bulb during the process. Note: This may be accomplished by inserting the thermometer in a gradually sloped shallow and closed extension of the retort. (i) The bottom of the overflow outlet shall be above the level of the top of the jars in the retort. (j) All recording thermometers, mercury thermometers, pressure gauges and gauge water glasses must be so placed in respect to light that they are easily readable. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28411, Health and Safety Code. s 12790. General. s 12795. Animal Food Sterilization Processes. s 12800. Asparagus Sterilization Processes. s 12805. Beans, Dry: Sterilization Processes. s 12810. Beans, Green and Wax, Whole or Cut: Sterilization Processes. s 12815. Beans, Lima and Soy: Sterilization Processes. s 12820. Bean Sprouts: Sterilization Processes. s 12825. Beets: Sterilization Processes. s 12830. Broccoli: Sterilization Processes. s 12835. Brussels Sprouts: Sterilization Processes. s 12840. Cabbage: Sterilization Processes. s 12845. Carrots: Sterilization Processes. s 12850. Carrot Juice: Sterilization Processes. s 12855. Carrots and Peas: Sterilization Processes. s 12860. Cauliflower: Sterilization Processes. s 12865. Celery: Sterilization Processes. s 12870. Chili Products: Sterilization Processes. s 12875. Corn: Sterilization Processes. s 12880. Corn Meal Mush: Sterilization Processes. s 12885. Fish Products: Sterilization Processes. s 12890. Hominy: Sterilization Processes. s 12895. Lentils in Unthickened Sauce: Sterilization Processes. s 12900. Mushrooms: Sterilization Processes. s 12905. Mushroom Sauce -Spaghetti Sauce: Sterilization Processes. s 12910. Olives: Sterilization Processes. s 12915. Parsnips: Sterilization Processes. s 12920. Peas: Sterilization Processes. s 12925. Potatoes: Sterilization Processes. s 12930. Potatoes, Sweet: Sterilization Processes. s 12935. Poultry Meat -Turkey: Sterilization Processes. s 12940. Pumpkin: Sterilization Processes. s 12945. Ravioli: Sterilization Processes. s 12950. Spaghetti: Sterilization Processes. s 12955. Spinach, Packing and Sterilization Processes. s 12960. Tamales, Cup: Sterilization Processes. s 12965. Vegetables, Chopped: Sterilization Processes. s 12970. Vegetables for Salad: Sterilization Processes. s 12975. Vegetables, Strained: Sterilization Processes. s 12976. Cookroom Personnel. In order to facilitate and expedite the administration and enforcement of these regulations, each canner shall select sufficient qualified person nel from his own employees who, to the satisfaction of the State Cannery Inspector, shall see that these regulations are followed. Note: Authority cited: Sections 102, 208, 26202, 26501 and 28440, Health and Safety Code. s 12977. Posting of Cooks Official cooks for all low acid products being packed must be conspicuously posted near the retorts. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 12978. Marking Containers. Each can, glass jar, or other food container, basket, truck, car or crate containing unretorted material to be processed in still retorts shall be plainly and conspicuously marked with a heat sensitive indicator which will visually indicate to all cookroom personnel whether or not each unit has been retorted. The marking of each individual food container with an indicator to indicate process status is desirable. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 12979. Time Limits. Not more than two hours shall elapse between the time the first can is closed, and the time steam is admitted to the retort containing that batch or cook, except (a) tuna which may be held for a maximum of three hours after closing, and (b) canned ripe olives and acidified food products packed under pH control for which the time limitation does not apply. In the event this time limit is exceeded, the cans or jars may be processed but shall be quarantined by the inspector until the Department has determined they are free from spoilage. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 12980. Double Door Retorts. No uncooked containers may be placed in a double door retort before the rear door has been closed. Deviations will be allowed only if prior approval has been obtained from the Department. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 12981. Retort Markers. A distinctive marker must be hung over the still retort opening when the retort contains unprocessed containers. It must be placed so that the door or lid cannot be locked before the marker is removed. A retort must not be locked until the operator indicates that it is ready for the process to start. Deviations will be allowed only if prior approval has been obtained from the Department. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 12982. Care of Containers. Any container which falls on the floor must be immediately picked up. Any container removed for inspection must be promptly returned. Any container of unproven status with regard to processing must be punctured. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 12983. Blanching. In the canning of leafy vegetables, all of the product which has been blanched must be canned and the containers closed within thirty minutes after shut down in order to prevent incipient spoilage before processing. If this period is exceeded, the product may be canned, but must be quarantined by the inspector until the Department has determined they are free from spoilage. All such material shall be carefully segregated so representative samples may be sent to the laboratory. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 12984. Posting Regulations. These regulations covering operation procedures must be conspicuously posted in all cookroom areas where they can be read and understood. Note: Authority cited: Sections 208 and 28440, Health and Safety Code. Reference: Section 28440, Health and Safety Code. s 13500. Olive Oil Regulations. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 208, Health and Safety Code. s 13600. Order Promulgating Standards. Under the authority of Section 28694.5 of the Health and Safety Code, the following regulations establishing definitions and minimum standards of operation and construction for mobile food preparation units and commissaries which service mobile food preparation units are hereby promulgated. Note: Authority cited for Article 10: Section 28694.5, Health and Safety Code. Reference: Sections 28590-28650, Health and Safety Code. s 13601. Definitions. (a) "Mobile food preparation unit" means any wheeled vehicle upon which ready-to-eat food is cooked, wrapped, packaged, processed, or portioned for service, sale or distribution. This section does not apply to a "bakery delivery vehicle" as defined in Section 28524 of the Health and Safety Code or a vehicle used only for the sale or delivery of fresh meat, fish, poultry, or produce. (b) "Mechanical refrigeration" means a unit which extracts heat from an area by means of liquefication and evaporation of a fluid by means of compressor or flame, or by means of a thermoelectric device. Acceptable mechanical refrigeration shall also include cold plates. s 13602. Exterior Requirements. (a) The name and address of the person operating the mobile food preparation unit shall be plainly indicated on each side of the exterior of the vehicle in letters of contrasting colors at least three inches high with a minimum 3/8 inch-wide stroke. Any of the following three methods are acceptable: (1) The name, street address, and city of the person in whose name the license is issued. Listing of the phone number is optional with the owner or operator of the vehicle. (2) The name of the owner or operator, or his business name and city, providing they are listed in the telephone directory. (3) The name of the operator or owner of the vehicle, or his business name, and the address of the commissary from which the vehicle is serviced. (b) Entrance doors to food preparation areas shall be self-closing and kept closed when not being used. (c) Compressor units that are not an integral part of equipment, auxiliary engines, generators, etc., shall be installed in an area that is completely separated from food preparation and food storage and which is accessible from outside the unit for proper cleaning and maintenance. The food preparation and storage area shall be so constructed so as to be rodent proof. (d) The exterior of the mobile food preparation unit and the surrounding area, as relating to the operation of the unit, shall be maintained in a sanitary condition by the operator of the unit. No attachment (such as a can opener) shall be mounted on the exterior of the mobile food preparation unit. Adequate waste containers shall be furnished for the use of customers. These containers shall be of easily cleanable construction and furnished with a tight-fitting cover and shall be kept clean. s 13603. Interior Requirements. (a) At least a two-compartment metal sink equipped with hot and cold running water with dual integral metal drainboards, installed with at least 1/8 inch per foot slope toward the sink, and fabricated with a minimum of 1/2 inch lip or rim to prevent the draining liquid from spilling onto the floor shall be provided. The dimensions of each compartment shall be at least 12 inches wide, 12 inches long, and 10 inches deep. Each drainboard shall be at least the size of one of the sink compartments. If multi-use eating and drinking utensils are used, the sink shall have three compartments; each compartment with a minimum size of 12" x 12" x 10." The drainboards shall be at least 12" x 12." Drainboards for a three-compartment sink shall comply with the requirements of drainboards for a two-compartment sink. The sink shall be equipped with a mixing faucet and shall be provided with a swivel spigot capable of servicing any sink compartment individually as desired. (b) Hand washing facilities, including a lavatory supplied with hot and cold running water with a mixing type faucet, hand washing detergent or soap and single-service sanitary towels in permanently installed dispensing devices shall be provided and maintained in each mobile food preparation unit. The hand washing facilities shall be separate from the utensil washing sinks. The lavatory basin must have a minimum dimension of 9" x 9" in width and 5 inches in depth. The hand washing facilities shall be separated from the utensil washing sinks by a metal guard with a height of at least three inches, and extending from the back edge of the drainboard to the front edge of the drainboard, the corners of the barrier to be rounded. No separation barrier is required if the distance between the hand washing sink and the utensil drainboards is two or more feet. Mobile food preparation vehicles in operation and built before the effective date of the regulations adopted December 5, 1969, may be accepted without separate hand wash basins until January 1, 1975, at which time they must comply with the regulations or discontinue operation. (c) Floors, walls, and ceilings shall be constructed so that the surfaces are impervious, smooth and cleanable. Floor surfaces shall provide employee safety from slipping. The juncture of the floors and walls shall be covered with the floor surface extending up the wall at least four inches. In all mobile food preparation units constructed after the effective date of these regulations there shall be a clear, unobstructed height over the aisle-way portion of the unit of at least 76 inches from floor to ceiling, and a minimum of 30 inches of unobstructed horizontal aisle space. (d) Construction joints and seams shall be sealed to provide smooth, easily cleanable surfaces. Soldered joints and seams shall be smooth to the touch. Silicone sealant or equivalent waterproof compounds shall be acceptable, providing they prevent the entrance of liquid waste or vermin. (e) All equipment shall be so installed as to be easily cleaned, prevent vermin harborage and provide adequate access for service and maintenance. Equipment shall be spaced apart for easy cleaning or shall be sealed together. Food equipment and machinery set apart from adjacent equipment or machinery, or the clearance between the top of the counter, or the bottom of a piece of equipment with a rigid utility connection, shall provide a minimum width of three inches of unobstructed space for sanitary maintenance beneath the counter equipment or the sides of adjacent equipment. Food equipment or machinery of a size and weight that can be easily picked up and moved by one person, and with a flex connection need not comply with minimum leg height requirement. No threads, nuts, or rivets shall be exposed where they interfere with cleaning. Should such threads, nuts, or rivets interfere with cleaning they shall be capped. On existing mobile food preparation units and equipment with exposed threads, nuts, screws, or rivets that can be cleaned with the usual, easily available cleaning equipment such as brushes, brooms, mops, cleaning cloths, or with steam, or flushing with water, shall be acceptable if maintained in a clean and sanitary condition. (f) All equipment shall be sealed to the floor to prevent moisture from getting under the equipment or it shall be raised at least six inches off the floor by means of an easily cleanable leg and foot. (g) Equipment, including the interior of cabinet units or compartments, shall be constructed so as to have smooth, easily accessible, and easily cleanable surfaces (free from channels, crevices, flanges, ledges, or other cleaning obstructions). Unfinished wooden surfaces are not permitted. Food contact surfaces shall be constructed of metal, high pressure laminated plastics, or laminated hardwood. These surfaces must be kept free of cracks, cuts, and other obstructions which would interfere with proper cleaning. (h) All utensils shall be designed and constructed so as to be easily cleanable and shall be made of nontoxic materials. (i) Space around pipes, conduits, or hoses that extend through cabinets, floors, or outer walls shall be sealed. The closure shall be smooth and easily cleanable. (j) Light bulbs, tubes, etc., shall be covered with a completely enclosed plastic safety shield or its equivalent. Light fixtures shall be installed so as to not constitute a hazard to personnel or food materials. (k) Waste receptacles shall be provided inside of the vehicle. They shall be constructed so as to be smooth, nonabsorbent and easily cleanable, and kept clean. ( l) No smoking signs and signs directing proper hand washing shall be posted in the food preparation area. (m) The interior of the mobile food preparation unit and all equipment and utensils in the unit shall be kept clean and in good repair and free of vermin. s 13604. Temperature Requirements. (a) Adequate mechanical refrigeration space shall be provided and each refrigerator shall be equipped with an easily readable thermometer. Wooden shelves are not permitted in the refrigerator. Readily perishable food shall be kept at 45 Fahrenheit, or below, at all times (except as provided in Subsection (b)). Readily perishable packaged food arranged for display and self-service may be held on an ice bed. Mobile units manufactured prior to the effective date of this Section are not required to have mechanical refrigeration space provided adequate nonmechanical refrigeration has been installed. (b) Adequate space shall be provided to maintain readily perishable food which is kept hot at a temperature of 140 Fahrenheit, or higher, and a suitable thermometer to test the internal temperature of food, accurate to plus or minus 2 Fahrenheit, must be available for measuring the temperature of the hot food. All readily perishable food which is not refrigerated shall be kept at 140 Fahrenheit, or higher, at all times. s 13605. Ventilation. Mechanical exhaust ventilation equipment shall be provided over all cooking equipment as required to effectively remove cooking odors, smoke, steam, grease and vapors. The ventilation shall be adequate to provide a reasonable condition of comfort for employees. Grease filters or other means of grease extraction are required and shall be of steel construction, or other approved material, and shall be readily accessible for cleaning. Every joint and seam shall be substantially tight. No solder shall be used, except for sealing a joint or seam. Every hood shall be so designed and installed to provide for thorough cleaning of the entire hood. When grease gutters are provided they shall drain to a collecting receptacle fabricated, designed, and installed to be readily accessible for cleaning. All ducts in the exhaust system shall have a slope of at least two inches per lineal foot. All seams in this duct work shall be substantially tight to prevent the accumulation of grease. The ducts shall have sufficient clean-outs to make the ducts readily accessible for cleaning. Make-up air shall be provided at the rate of that exhausted. It may be accomplished from screened service openings, vents in the ceiling, or mechanically through an air-conditioning system, but not through open doors or openable windows. s 13606. Storage. (a) Spare tires, related automotive equipment, or special tools relating to the mechanical operation of the mobile food preparation unit shall not be stored in the food preparation or food storage areas. (b) A separate cabinet or drawer shall be installed for the storage of insecticides or other poisonous substances, if such substances are used. All poisonous chemicals shall be kept in this cabinet, or drawer in their original containers, and in a manner that offers no contamination hazard to food or utensils. (c) Suitable facilities shall be provided for the storage of linens, uniforms, and other related linens. Suitable facilities such as a cabinet or drawer shall be provided for the storage of personal belongings. All personal belongings shall be kept in the space provided. (d) All pressure cylinders shall be securely fastened to a rigid structure of the vehicle. All liquefied petroleum equipment shall be installed to meet fire department standards and other laws that are applicable. A minimum 5 B.C.- rated fire extinguisher to combat grease fires shall be installed on the interior of each mobile food preparation unit in a readily accessible place. (e) Adequate and suitable space shall be provided for the orderly storage of food and food service materials. (f) Single-service utensils shall be stored in their original enclosed package, in a clean, dry area. They shall be kept in an approved, enclosed dispenser for customer use. Straws shall be wrapped or dispensed from approved, enclosed dispensers. An enclosed dispenser shall protect the lip-contact portion of the eating and drinking utensil from contamination. s 13607. Service Openings. (a) Service openings shall be limited to 216 square inches each. The service openings may not be closer together than 18 inches. They shall be self-closing with a screen of not less than 16 mesh per inch, or a solid closing device. With the exception of the service openings the entire food preparation and food storage area shall be enclosed with a solid, easily cleanable material. The counter surface of the service openings shall be smooth and easily cleanable. s 13608. Power Supply. Whenever the vehicle is in service, adequate electrical power shall be provided to operate the approved exhaust, lighting, and refrigeration systems, or any other accessories and appliances that may be installed on a mobile food preparation unit. s 13609. Water Supply, Plumbing. (a) A water supply tank of sufficient capacity to furnish an adequate quantity of potable water for food preparation, cleaning, and hand washing purposes shall be provided (minimum 30 gallons). Hose connection valves shall be at least five feet above the ground and be kept covered with a protective screw-type cap, which is attached to the vehicle. The water supply shall meet health department requirements of potability as specified in Chapter 7 (commencing with Section 4010) of Part 1, Division 5 of the Health and Safety Code. The water system shall be of such materials and designed and constructed so water or air can be introduced without the water becoming contaminated. The water system shall deliver at least one gallon per minute to each sink basin in the unit. (b) A hot water heater with a minimum capacity of three gallons, or an instantaneous heater capable of producing water of 120 Fahrenheit interconnected with the potable water supply, shall be provided and shall operate independently of the vehicle engine and/or generator. Hot and cold water, under pressure, shall be provided at hand washing and utensil sinks units from mixing faucets. (c) The liquid waste tank shall have a capacity at least 50 percent greater than the fresh water tank, and shall receive and be adequate to hold melting ice water resulting from one day's operation. (d) All tanks, lines, couplings, valves, or any other plumbing shall be designed, installed, maintained, and constructed of materials that will not contaminate the water supply, food, utensils, or equipment. (e) Water and waste storage tanks shall be installed so as to be easily drained, flushed, and cleaned with an easily accessible outlet. Breather tubes or overflow pipe openings shall be protected from the entrance of dust, insects, and other contamination. All waste lines shall be connected to the waste tank with watertight seals. (f) The water supply tank shall be filled and the waste storage tank shall be emptied only at the commissary or other facilities approved by the health officer. (g) Toilet facilities for the use of the food service personnel shall be available within 100 feet of the vehicle whenever it is stopped to conduct business for more than a one-hour period. (h) Mobile food preparation units may be connected to an approved water supply and sewerage disposal system. Such units shall be equipped with a hose or other approved connection to attach to the water system. This connection shall be used for no other purpose and shall be protected from contamination at all times. In order to avoid confusion, all water connections shall be green in color. Waste lines shall be a color other than green. s T17-13611. General Requirements. (a) The requirements of this article shall be the minimum requirements for commissaries which service mobile food preparation units in the State of California. Note: Authority cited for Article 10.1: Section 28694.5, Health and Safety Code. Reference: Sections 28590 through 28650, Health and Safety Code. s 13612. Waste Handling and Disposal. (a) Each commissary which services mobile food preparation units, shall have on the premises adequate facilities for: (1) Handling liquid waste from the mobile unit being serviced. Such facility shall be constructed so that waste can be handled in a safe and sanitary manner. (2) Handling and disposing of garbage and rubbish which originates on the mobile unit. The waste receptacles shall be constructed so as to be easily cleaned and securely covered. s 13613. Water Supply and Plumbing. (a) Each commissary which services mobile food preparation units shall have potable water available for filling the water tanks of mobile units. Such watering facilities shall be constructed so as to minimize the possibility of contaminating the water being loaded. (b) The hose used for filling water tanks shall be constructed of a nontoxic material (NSF approval recommended). It shall be green in color and shall be used for no other purpose. At all times the hose shall be kept at least four feet above the ground. (c) Hot and cold water, under pressure, shall be available for cleaning the mobile unit. (d) Potable water supply shall at all times be protected from potential backflow. s T17-13614. Electrical Hook-Up Facilities. (a) Each commissary which services mobile food preparation units shall have available sufficient, suitable electrical outlets for mobile units which require electrical service. These outlets shall be constructed to comply with the applicable provisions of Part , Title 24, California Administrative Code. s T17-13615. Toilet and Lavatory. (a) Each commissary which services mobile food preparation units shall have available suitable toilet and lavatory facilities for the use of the operators of the mobile units. These facilities shall be provided with hot and cold running water with mixing faucets, or tempered (110 degrees -115 degrees F) running water, soap and sanitary towels in permanently installed dispensing devices. Toilet facilities shall be kept clean and in good repair. (b) If toilet facilities are used by five or more people of different sex, separate facilities for each sex shall be provided. The ratio of toilets to employees shall be as required in Section B-1105, Part 2, Title 24, California Administrative Code, and one additional toilet and lavatory facility shall be provided for each additional 60 mobile unit operators of the same sex on the premises at any one time. s T17-13616. Facilities for Food Storage. (a) Each commissary which services mobile food preparation units shall have adequate facilities for storing all food and supplies which are loaded on the mobile units. No food or food in a container shall be stored directly on the floor. They shall be stored at least six inches above the floor, or under such other conditions as are approved by the State Health Department. "Other conditions" that may be acceptable are storage of foods on moveable pallets with a minimum height of five inches. (b) Perishable food shall be stored in devices which maintain the temperature of the food at 45 Fahrenheit, or below, or 140 Fahrenheit, or above, at all times. These devices shall be equipped with thermometers which are located so as to be easily read. s 13620. Definitions. (a) "Wallboard" means any permanent sign used to display or describe food items for sale in a restaurant. (b) "Placard" means any non-permanent sign used to display or describe food items for sale in a restaurant. (c) "Menu" means any list presented to the patrons stating the food items for sale in a restaurant. Note: Authority cited: Sections 208, 26202 and 26596, Health and Safety Code. Reference: Section 26596, Health and Safety Code. s 13621. Wallboard and Placard Requirements in Restaurants Without Menus. Restaurants serving imitation hamburger containing more than 10 percent added protein and water or other extenders or binders shall post an ingredient statement on a wallboard or placard. (a) The ingredients shall be listed in descending order of predominance by weight. (b) The term "imitation hamburger," or any other term which accurately informs the customer of the nature of the product and its ingredients, shall be stated in letters at least one (1) inch in height (72 point letters) in bold-face type in colors which contrast with the wallboard or placard. (c) The wallboard or placard shall be posted in a permanent place, conspicuous to the customers, in each room or area where food is served. Note: Authority cited: Sections 208, 26202 and 26596, Health and Safety Code. Reference: Section 26596, Health and Safety Code. s 13650. Definitions. (a) "Roadside Stand" means a food establishment which has one or more sides open to the outside air during hours of business, which sells produce or shell eggs or both, and where no more than ten percent of the floor space of the food sales and storage area is devoted to packaged foods. (b) "Food Establishment Open to the Outside Air" means a food establishment which has one or more sides open to the outside air during hours of business, and where over ten percent of the floor space is devoted to the storage and sale of packaged foods to consumers. (c) "Retail Dairy" means a food establishment of which milk or milk products to be sold directly to the consumer constitute over 50 percent of the volume of sales. Processing and packaging facilities as defined in Sections 32505 and 32513 of the California Food and Agricultural Code shall not be considered part of the retail dairy. (d) "Retail Sales Area of Grower-Seller Premises" means the retail sales area operated by a grower or producer only for the sale of his own produce or shell eggs or both directly to the consumer. These products must be grown or produced on property owned, rented, or leased by the grower or producer, and on which the sales area is located. (e) "Employee" means any person working in an establishment governed by the provisions of this Article. (f) "Food Preparation" means any operation by which the form, flavor, or consistency of food is changed. It includes, but is not limited to, cooking, seasoning, cutting, and grinding. (g) "Milk and Milk Products" means those food items which are defined in Sections 32510-32512 of the California Food and Agricultural Code, Division 15, Part 1, Chapter 1. Milk and milk products will be considered to be packaged foods. (h) "Packaged Foods" means foods in a package, as defined in Section 26023 of the California Health and Safety Code. The package shall conform to the applicable provisions of Chapter 4 of Division 21 (commencing with Section 26400) of the California Health and Safety Code. The packaging of such products shall be done at a facility approved by the local health officer. Processing and packaging facilities as defined in Sections 32505 and32513 of the California Food and Agricultural Code shall be exempt from this requirement. (i) "Potentially Hazardous Food" means any food which consists in whole or in part of ingredients capable of supporting rapid and progressive growth of infectious or toxicogenic microorganisms, including, but not limited to, milk or milk products, eggs, meat, poultry, fish or shellfish. It does not include food that has been processed and packaged so as to prevent the growth of pathogenic microorganisms, or any uncracked shell eggs. (j) "Produce" means any fruit or vegetable in its raw or natural state. (k) "Produce Preparation" means any operation by which the form, flavor or consistency of the produce is changed. It includes, but is not limited to, cooking, seasoning, cutting, trimming, and grinding. ( l "Trimming" means the removal of part of the produce, such as outer leaves, stems, stalks, roots, and tops. (m) "Utensil" means any kitchenware, cutlery, container, implement, wrapper or other equipment with which food comes in contact during storage, display, preparation, sale, or through use by an employee or consumer. Note: Authority cited: Sections 208 and 28802.5, Health and Safety Code. Reference: Section 28802.5 Health and Safety Code. s 13651. Structural and Operational Requirements. Note: Authority cited: Sections 208 and 28802.5, Health and Safety Code. Reference: Section 28802.5, Health and Safety Code. s 13652. Health Requirements. (a) All employees shall wear clean washable outer garments and shall keep their hands clean at all times while engaged in handling food, beverages, or utensils. All employees shall wash their hands and arms with soap or detergent and water before commencing work after using toilet facilities, before returning to work, and at such other times as are necessary to prevent contamination of food. Legible signs shall be posted in each toilet room directing attention to this requirement. (b) When information as to the possibility of disease transmission is presented to the local health officer, he shall investigate conditions and take appropriate action. The health officer may, after investigation and for reasonable cause, require any or all of the following measures to be taken: (1) The immediate exclusion of such employee or owner from the affected food establishment; (2) The immediate closing of the establishment until in the opinion of the health officer no further danger exists; (3) Medical examination of the owner and employees, with such laboratory examination as may be indicated, or should such examination or examinations be refused, the immediate exclusion of the refusing owner or employee from that or any other food establishment operation until a medical or laboratory examination shows that he is not affected with, or a carrier of, any disease in a communicable form. Note: Authority cited: Sections 208 and 28802.5, Health and Safety Code. Reference: Section 28802.5, Health and Safety Code. s 13653. Enforcement and Inspection. Note: Authority cited: Sections 208 and 28802.5, Health and Safety Code. Reference: Section 28802.5, Health and Safety Code. s 13670. Adoption of the 1976 Uniform Mechanical Code. Chapter 4-20 of Title 24, California Administrative Code, shall be the commercial hood and kitchen ventilation standards for retail food establishments as defined in Title 17, California Administrative Code, Section 12100(a). Note: Authority cited: Sections 208, 28694, 28694.5 and 28863, Health and Safety Code. Reference: Sections 28196, 28545 and 28826, Health and Safety Code. s 13671. Building Plan Approval. (a) Building plans for new construction or remodeling of kitchen ventilation systems in retail food establishments shall be submitted for review and approval to either the local health officer or a duly authorized registered sanitarian. (b) Construction or installation shall not begin without prior written approval that the building plan complies with the requirements of Section 13670. Note: Authority cited: Sections 208, 28694, 28694.5 and 28863, Health and Safety Code. Reference: Sections 28196, 28545, 28826 and 28865, Health and Safety Code. s 13675. Raw Gulf Oysters: Labeling, Written Warnings and Additional Requirements. (a) For purposes of this article, the following definitions shall apply: (1) "Dealer" means a person who shucks, packs, re-packs, processes, labels, re-labels, ships, re-ships, holds or otherwise sells shellfish. "Dealer" does not include persons solely engaged in retail activities as defined in the Health and Safety Code, Section 113875. (2) "Gulf oyster" means any oyster harvested from the states of Alabama, Florida, Louisiana, Mississippi, or Texas. (3) "Half-shell oyster" means any oyster from which one shell has been removed. (4) "MPN" (Most Probable Number) means a statistical estimate of the number of bacteria per unit volume determined from the number of positive results in a series of fermentation tubes. (5) "Non-detectable level" means that the MPN ofVibrio vulnificus bacteria is less than 3 MPN per gram of product as determined by theVibrio vulnificustesting method in the U.S. Food and Drug Administration Bacteriological Analytical Manual, 8th Edition, 1995, pages 9.01-9.27, hereby incorporated by reference. (6) "Offers" means making raw oysters available to any person, whether the raw oysters are subject to purchase, exchange, or transfer, or are provided without charge. (7) "Orders" means requesting or selecting raw oysters for consumption on the premises of a retail food facility, or requesting or selecting raw oysters for consumption off the premises. (8) "Oyster treatment process" means a process that has been determined by the state shellfish control authority having jurisdiction, the U.S. Food and Drug Administration, or a recognized process authority to consistently reduce the level ofVibrio vulnificus to a non-detectable level. (9) "Recognized process authority" means the person(s) or organization(s) recognized by the state shellfish control authority or the U.S. Food and Drug Administration as having expert knowledge of oyster treatment processes, and having adequate facilities for making such determinations. (10) "Retail food facility" means "retail" as defined in section 113875 of the Health and Safety Code and "food facility" as defined in section 113785 of the Health and Safety Code. (11) "Shellfish Control Authority" means the State, or other regulatory authority, or its designated agents responsible for the enforcement of laws or regulations governing shellfish growing and harvesting areas, shellfish handling facilities and dealer activities including harvesting, transporting, storing, handling, processing, packing, and repacking of shellfish. (12) "Shellstock oyster" means any oyster in both shells. (13) "Shucked oyster" means any oyster from which both shells have been removed and which has been packed in a container by a dealer. (14) "Tent cards" means free-standing print displays or a printed display in a supporting stand designed for placement on dining tables or food service counters. (b) Every retail food facility that offers raw Gulf oysters shall provide a written warning to any person who orders raw oysters, as provided in this section. (1) The written warning shall be worded in English and Spanish as follows: WARNING THIS FACILITY OFFERS RAW OYSTERS FROM THE GULF OF MEXICO. EATING THESE OYSTERS MAY CAUSE SEVERE ILLNESS AND EVEN DEATH IN PERSONS WHO HAVE LIVER DISEASE (FOR EXAMPLE ALCOHOLIC CIRRHOSIS), CANCER OR OTHER CHRONIC ILLNESSES THAT WEAKEN THE IMMUNE SYSTEM. If you eat raw oysters and become ill, you should seek immediate medical attention. If you are unsure if you are at risk, you should consult your physician. AVISO IMPORTANTE ESTA FACILIDAD OFRECE OSTRAS CRUDAS DEL GOLFO DE MEXICO. A COMER ESTAS OSTRAS CRUDAS PUEDEN CAUSAR UNA ENFERMEDAD GRAVE Y HASTA LA MUERTA EN LAS PERSONAS QUE PADECEN DE ENFERMEDADES DEL HIGADO (POR EJEMPLO, CIRROSIS ALCOHLICA), CANCER U OTRAS ENFERMEDADES CRONICAS QUE DEBILITAN EL SISTEMA INMUNOLOGICO Si usted come ostras crudas y se enferma, debe buscar atencion medica inmediatamente. Si usted cree estar en peligro, debe consultar a un medico. (2) Where raw oysters are purchased by a consumer over a counter, or where they are offered for sale by a sign, tag, or menu board, the sign bearing the warning set forth in subsection (b)(1) shall be prominently placed so that it is likely to be read by consumers prior to ordering raw oysters. The warning signs shall meet the following specifications: (A) Be square in shape and no smaller than 10 inches on a side (100 square inches) or be rectangular in shape and no smaller than 11 inches high by 8.5 inches wide (93.5 square inches). (B) Be printed in black ink on a white background, dark blue ink on a yellow background or other ink that is of high contrast from the color of the background material. (C) At least 1/3" space shall be maintained around the notice (D) The word "Warning" and the words "Aviso Importante" shall be in all bold, upper case letters and underlined and be no smaller than 35 point type face. (E) The first two sentences of the English and the Spanish version shall be in bold letters and be no smaller than 30 point type face. The remaining sentences of the English and the Spanish version shall be no smaller than 25 point type face. (3) Where raw oysters are ordered directly from a server, at a dining table, or where a warning sign posted pursuant to subsection (b)(2) is not clearly legible from any location where the consumer orders raw oysters, the warnings shall be printed on all menus in which raw oysters are listed, or on tent cards located on each dining table. For menus, the warning may be shortened to contain the headers and the first two sentences of the English and Spanish statements as set forth in subsection (b)(1) and shall be prominently placed on the menu so that it is likely to be read by consumers prior to ordering raw oysters. Tent cards shall contain the complete warning statements as set forth in subsection (b)(1) and be prominently placed on the dining tables so that they are likely to be read by consumers prior to ordering raw oysters. Both menu warning statements and tent card warning statements shall meet the following specifications: (A) Be printed in black ink on a white background, dark blue ink on a yellow background or other ink that is of high contrast from the color of the background material. (B) The word "Warning" and the words "Aviso Importante" shall be in all bold, upper case letters and underlined. (4) Menu warning statements shall meet the following additional specifications: (A) Be no smaller than 10 point type face. (B) Be enclosed by a box rule with no less than 1/8" of space around the notice. (5) Tent card warning statements shall meet the following additional specifications: (A) Be square in shape and no smaller than 4 inches on a side (16 square inches) or be rectangular in shape and no smaller than 3 inches high by 5 inches wide (15 square inches). (B) The word "Warning" and the words "Aviso Importante" and the first two sentences of the English and Spanish version shall be in no smaller than 12 point medium or bold type face, and the remaining sentences shall be no smaller than 10 point type face. (C) Be enclosed by a box rule with no less than 1/8" of space around the notice. (c) Every dealer or retail food facility that offers raw oysters from any source shall do all of the following: (1) Refuse to accept any container of raw shellstock oysters, half-shell oysters, or shucked oysters, if the container does not have a tag or label affixed that prominently and clearly bears the statement "Harvested in______________________________", "Product of______________________________", or words of similar meaning (to be filled in with the name of the state or foreign country in which the raw oysters were harvested). For containers of raw oysters that have any oyster harvested from a state bordering on the Gulf of Mexico, this paragraph is satisfied when the container bears a tag or label affixed that prominently and clearly bears the statement", or words of similar meaning (to be filled in with the name of the state or foreign country in which the raw oysters were harvested). For containers of raw oysters that have any oyster harvested from a state bordering on the Gulf of Mexico, this paragraph is satisfied when the container bears a tag or label affixed that prominently and clearly bears the statement "Harvested from the Gulf of Mexico", or "Product of the Gulf of Mexico". (2) Refuse to accept raw shellstock oysters unless each container contains a tag or label that prominently and clearly bears all of the following: (A) The harvest date of the oysters. (B) The bed name or lease number assigned by the shellfish control authority to the harvest area. (C) The state abbreviation and certification number assigned by the shellfish control authority to the harvester, or original dealer. (3) Refuse to accept raw shucked oysters unless each container of oysters bears a label that prominently and clearly states all the following: (A) The sell-by-date, date-shucked, date-packed, or similar date of the shucked oysters. (B) The state abbreviation and certification number assigned by the shellfish control authority of the state or foreign country to the harvester or original dealer. (C) The harvest date of raw Gulf oysters. This requirement is satisfied when each shipment of raw oysters is accompanied by an invoice that specifies the harvest date of the oysters. (D) That raw Gulf oysters, which have not been subjected to an oyster treatment process, be cooked before eating. (4) Refuse to accept any container of raw half-shell oysters unless each container of oysters bears a tag or label that prominently and clearly states the information required in subparagraphs (c)(3)(A), (B), and (C). (5) Refuse to accept any container of raw shellstock, half-shell, or shucked Gulf oysters harvested during April through October, and such oysters shall be deemed adulterated, unless: (A) The oysters have been subjected to an oyster treatment process and are prominently and clearly tagged or otherwise labeled with the information required by subsection (i); and (B) The dealer or retail food facility has on file a current copy of the letter from the department verifying the use of an oyster treatment process in accordance with subsection (h). (d) Warnings under subsection (b) are not required for raw shellstock, half-shell or shucked Gulf oysters whenever the retailer has received a copy of a current verification letter from the dealer pursuant to subsection (h) and tags or labels as required by subsection (i) demonstrating that the oysters have been subjected to an oyster treatment process. (e) In order to be eligible to receive verification by the department that oysters supplied by the dealer are subjected to an oyster treatment process, a dealer shall submit a written request for verification pursuant to Section 13676. A verification issued by the department shall be valid for two years from the date of issue unless revoked or suspended. (f) A dealer who has received a verification pursuant to Section 13676 shall notify the department in writing prior to making any changes to the oyster treatment process, or any changes to the Hazard Analysis and Critical Control Point (HACCP) plan required by Title 21, Code of Federal Regulations, Part 123. (g) A dealer who has received a verification pursuant to Section 13676 shall notify the department, within seven days, of any new information known to the dealer pertaining to the effectiveness of the oyster treatment process. (h) A dealer who has received verification pursuant to Section 13676 shall provide a copy of the letter from the department granting the current verification to every dealer and retail food facility in California to whom the dealer sells or provides shellstock, half-shell, or shucked raw Gulf oysters. Every dealer and retail food facility that offers shellstock, half-shell, or shucked raw Gulf oysters for which verification pursuant to Section 13676 has been granted, shall retain and make available for inspection by the department and local health agencies a copy of the current verification letter provided by the dealer. A retail food facility shall retain the copy of the verification for one year after the date that the verification expires. (i) A dealer who has received verification pursuant to Section 13676 shall affix to each container of raw Gulf oysters processed to reduceVibrio vulnificus to a non-detectable level, a tag or label pursuant to subsections (c)(2), (c)(3), and (c)(4), as required. In addition to requirements of subsections (c)(2), (c)(3), and (c)(4), such tag or label shall clearly and prominently bear the phrase "PROCESSED TO REDUCE VIBRIO VULNIFICUS TO NON-DETECTABLE LEVELS", followed by a lot number traceable to the dealer's processing records. Use of the phrase "PROCESSED TO REDUCE VIBRIO VULNIFICUS TO NON-DETECTABLE LEVELS", or words of similar meaning on tags or labels of raw unprocessed oysters, or on tags or labels of processed raw oysters from other than a dealer who has a current verification from the department is unlawful, and causes the oysters to be misbranded. Note: Authority cited: Sections 100275, 110065, 110105, 110430, 112165 and 113710, Health and Safety Code. Reference: Sections 110175, 110545, 112165(c), 112195, 112200 and 113980, Health and Safety Code. s 13676. Request for Verification. (a) A request for verification by the department that oysters supplied by a dealer are subjected to an oyster treatment process shall include all of the following: (1) The name and address of the dealer; (2) A copy of the shellfish certificate or license issued by the Shellfish Control Authority having jurisdiction; (3) A description of the process used to treat the oysters and the procedures used to ensure that oysters harvested during April through October and shipped to California are subjected to the treatment. (4) A report by the Shellfish Control Authority or a recognized process authority, accompanied by the concurrence of the U.S. Food and Drug Administration verifying that the process used consistently reduces the level ofVibrio vulnificusto a non-detectable level. (5) Signature, under penalty of perjury, of the individual requesting verification attesting to the accuracy of the information provided in the request for verification. (b) Requests for verification shall be deemed complete when the information specified in subsection (a) has been received in writing by the department. Initial requests for verification may be submitted at any time to the department. Requests for renewals shall be submitted to the department no later than 60 days prior to the expiration date. Requests for verification shall state whether the dealer is requesting an initial verification or renewal of an existing verification. (c) The department shall notify the dealer in writing within 15 days of receipt of a request for verification of one of the following: (1) The request for verification is complete and shall be evaluated by the department, or (2) The request for verification is incomplete and not accepted for evaluation. The department's written notification shall describe the specific information or documentation that is deficient. (d) Within 60 days of the receipt of a complete request for verification, the department shall notify the dealer of one of the following: (1) That the oyster treatment process has been verified, or (2) That the request has been reviewed and denied for failure to establish that each oyster harvested during April through October and sold or distributed in California will be subjected to an oyster treatment process. The department shall provide a written description in the notification of the basis for the denial. (e) Written notification by the department to dealers requesting verification shall be deemed to occur on the date that the notification is postmarked. (f) The department shall deem a request for verification abandoned by a dealer requesting verification who fails to respond or to supply information or documents within 30 days of notification by the department. (g) The time periods for processing a request for verification from the date of receipt by the department are as follows: (1) The median time for processing a request is 45 days. (2) The minimum time for processing a request is 20 days. (3) The maximum time for processing a request is 60 days. (h) The department may revoke or suspend a verification granted pursuant to Section 13675(e) and this section for any failure of the dealer to ensure the use of the oyster treatment process as described in the request for verification, for any failure of the oyster treatment process to reduceVibrio vulnificus to non-detectable levels, or for any violation by the dealer of this article. The department shall inform the person of any denial, revocation, or suspension in writing, stating the reasons for the denial, revocation, or suspension. Note: Authority cited: Section 15376, Government Code; and Sections 100275, 110065, 110105, 110430 and 112165(a), Health and Safety Code. Reference: Sections 110435, 110545, 110660, 112165(c), 112195, 112200 and 113980, Health and Safety Code. s 13700. Frozen Food Locker Regulations. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 208, Health and Safety Code. s 13701. Licenses for Frozen Food Locker Plants. (a) Licenses for Frozen Food Locker Plants will be valid for a two-year period from date of issue and are not transferable. The fee for the license is $50.00. (b) Application for a Frozen Food Locker Plant license shall be made on State Department of Health form #EH-6. (c) The fee shall accompany the application and shall not be refundable. (d) The licensee shall immediately notify the Department of any change in the information which was submitted on the license application. Note: Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code. Note: Authority cited for Article 12: Sections 102 and 208, Health and Safety Code. Reference: Sections 28740 through 28755, 28778 and 28779, Health and Safety Code. s 15200. Order Promulgating Standards. s 15205. General Regulations. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 15210. Examinations and Investigations -Samples. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 15215. General Methods for Water Capacity and Fill of Containers. s 15220. General Statements of Substandard Quality and Substandard Fill of Container. s 15405. Macaroni Products: Identity; Label Statement of Optional Ingredients. s 15410. Enriched Macaroni Products: Identity; Label Statement of Optional Ingredients. s 15415. Milk Macaroni Products: Identity; Label Statement of Optional Ingredients. s 15420. Whole Wheat Macaroni Products: Identity; Label Statement of Optional Ingredients. s 15425. Wheat and Soy Macaroni Products: Identity; Label Statement of Optional Ingredients. s 15430. Vegetable Macaroni Products: Identity; Label Statement of Optional Ingredients. s 15435. Noodle Products: Identity; Label Statement of Optional Ingredients. s 15440. Enriched Noodle Products: Identity; Label Statement of Optional Ingredients. s 15445. Wheat and Soy Noodle Products: Identity; Label Statement of Optional Ingredients. s 15450. Vegetable Noodle Products: Identity; Label Statement of Optional Ingredients. s 15455. Oriental Style Noodles, Chinese Style Noodles, Japanese Style Noodles, Korean Style Noodles: Identity; Label Statement of Ingredients. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 15460. Tagliarini: Identity; Label Statement of Optional Ingredients. s 15465. Use of Secondhand Boxes for Alimentary Pastes. s 15575. Tomato Catsup, Puree, and Paste. A mold tolerance of 40 percent of the microscopic fields is not to be exceeded in cases of tomato catsup, puree, and paste. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26523, Health and Safety Code. s 15580. Tomato Juice. The mold tolerance in case of tomato juice should not exceed 20 percent of the microscopic fields. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26523, Health and Safety Code. s 15585. Comminuted Tomato Products. Comminuted tomato products exceeding mold count tolerances specified in Section 15575 and Section 15580 cannot be used as ingredients of manufactured foods such as tomato soup, spaghetti sauce, etc. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26523, Health and Safety Code. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 15825. Sea Food Cocktails. Sea food cocktails are the food products prepared by immersing the clean, cooked, edible portions of sea food ingredients in a suitable acidified sauce. (a) Sauce. A suitable cocktail sauce may be made from catsup or other acidulated tomato product with or without the addition of pieces and/or sodium benzoate. A sufficient amount of vinegar or other food acid shall be added to bring the pH of the sauce to 3.70 or lower. This pH shall be checked by the packer for every batch of sauce. (b) "Meat" Ingredient. (1) The sea food ingredient of sea food cocktails must represent not less than 30 percent of the weight of the finished product. (2) If such ingredient consists wholly of the "meat" of one type of sea food such as crab meat, shrimp, oyster, etc., the product may be named after that ingredient. (3) If a mixture of two sea food ingredients are used the product may be so named to indicate this fact, stating first the name of the sea food ingredient present in greatest quantity. (4) If a mixture of more than two sea food ingredients is used in substantial quantities the product may be labeled "mixed sea food cocktail" or the names of the three or more sea food ingredients may be stated in the order of their predominance by weight. Note: Authority cited: Sections 208 and 25610, Health and Safety Code. Reference: Sections 25610 and 25612, Health and Safety Code. Note: Authority cited: Sections 208 and 25610, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 15830. Eggs. s 15835. Liquid Eggs, Mixed Eggs, Liquid Whole Eggs, Mixed Whole Eggs: Identity. s 15840. Frozen Eggs, Frozen Whole Eggs, Frozen Mixed Eggs: Identity. s 15845. Dried Eggs, Dried Whole Eggs; Identity. s 15850. Egg Yolks, Liquid Egg Yolks, Yolks, Liquid Yolks: s 15855. Frozen Yolks, Frozen Egg Yolks: Identity. s 15856. Egg Whites, Liquid Egg Whites, Liquid Egg Albumen; Identity. s 15857. Frozen Egg Whites, Frozen Egg Albumen; Identity. s 15860. Dried Egg Yolks, Dried Yolks; Identity. s 15861. Dried Egg Whites, Egg White Solids, Dried Egg Albumen, Egg Albumen Solids; Identity. s 15865. Cacao Nibs, Cocoa Nibs, Cracked Cocoa: Identity; Label Statement of Optional Ingredients. s 15870. Chocolate Liquor, Chocolate, Baking Chocolate, Bitter Chocolate, Cooking Chocolate, Chocolate Coating, Bitter Chocolate Coating; Identity: Label Statement of Optional Ingredients. s 15875. Breakfast Cocoa, High Fat Cocoa: Identity; Label Statement of Optional Ingredients. s 15880. Cocoa, Medium Fat Cocoa: Identity; Label Statement of Optional Ingredients. s 15885. Low-Fat Cocoa: Identity; Label Statement of Optional Ingredients. s 15890. Sweet Chocolate, Sweet Chocolate Coating: Identity; Label Statement of Optional Ingredients. s 15895. Milk Chocolate, Sweet Milk Chocolate, Milk Chocolate Coating, Sweet Milk Chocolate Coating: Identity; Label Statement of Optional Ingredients. s 15900. Skim Milk Chocolate, Sweet Skim Milk Chocolate, Skim Milk Chocolate Coating, Sweet Skim Milk Chocolate Coating: Identity; Label Statement of Optional Ingredients. s 15905. Buttermilk Chocolate, Buttermilk Chocolate Coating: Identity; Label Statement of Optional Ingredients. s 15910. Mixed Dairy Product Chocolate, Mixed Dairy Product Chocolate Coating: Identity; Label Statement of Optional Ingredients . s 15915. Sweet Chocolate and Vegetable Fat (Other Than Cacao Fat) Coatings: Identity; Label Statement of Optional Ingredients. s 15920. Sweet Cocoa and Vegetable Fat (Other Than Cacao Fat) Coatings: Identity; Label Statement of Optional Ingredients. s 15925. Distinction Between "Extract" and "Flavor." Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 15975. Labeling Defined. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 15980. Where Label Statements Must Appear. All required information shall appear on the main display panel of the bottle and carton. If more than one panel is used for display, the required information shall appear on each. This statement applies to the name of the product, list of ingredients when required, declaration of artificial color, added preservative, name and address of the manufacturer, distributor or packer, and the statement of the quantity of contents. s 15985. Name and Address of Manufacturer or Distributor. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 15990. Quantity of Contents Statement. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 15995. Listing of Ingredients. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 16000. Artificial Coloring. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 16005. Artificial Flavoring. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 16010. Chemical Preservatives. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 16015. Guaranty Statements. Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26051 and 26202, Health and Safety Code. s 16020. Misleading Containers. s 16025. Definitions. s 16030. Sirup. s 16035. Sugar-Cane Sirup. s 16040. Sorghum Sirup. s 16045. Maple Sirup. s 16050. Sugar Sirup. s 16055. Imitation Sirups. s 16060. Labeling of Sirups. s 16065. Vinegar, Cider Vinegar, Apple Vinegar. s 16070. Distilled Vinegar, Spirit Vinegar, Grain Vinegar. s 16075. Wine Vinegar, Grape Vinegar. s 16080. Malt Vinegar, Beer Vinegar. s 16085. Spices. s 16090. Labeling of Vinegars. s 16095. Adulteration. s 16100. Imitation Vinegar. s 16105. Manner of Holding Bulk Ripe Olives. All bulk ripe olives shall be held in kegs or barrels in a brine solution containing as a minimum 2 1/2 percent salt (10 degrees salometer). Note: Authority cited: Sections 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26050, 26209 and 26520, Health and Safety Code. s 16110. Label Stipulations of Bulk Ripe Olives. All barrels or kegs containing ripe olives shall have a label affixed thereto bearing the following statement: The Contents of This Keg or Barrel Shall Not be Held or Preserved in Closed or Sealed Glass Jars or Tins Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26050 and 26520, Health and Safety Code. s 16112. Definitions. (a) The term "Canned Ripe Olives" refers to olives of the "ripe type" or the "green-ripe type." (1) "Ripe type" olives are those which have been treated and oxidized in processing to produce a typical dark brown to black color. (2) "Green-ripe type" olives are those which have not been oxidized in processing and which range in color from yellow-green; green-yellow or other greenish casts; and which may be mottled. Note: Authority cited: Sections 208, 26202 and 26510, Health and Safety Code. Reference: Section 26510, Health and Safety Code. s 16113. Labeling. (a) Cans of Ripe Olives shall bear a label which meets all of the labeling requirements set forth in Article 4, Sections 26550 thru 26562 of the California Health and Safety Code and in addition, shall bear all of the following information: (1) A statement of the drained weight. (2) A size designation according to one of the seven sizes set forth in Table 1. (3) A cut or imprint which represents the approximate size of the fruit designated as set forth in Table 1. (b) Cans of Ripe Olives with counts per pound between two size ranges shall be labeled as the lesser or smaller size. TABLE 1. SIZE -CANNED WHOLE AND PITTED RIPE OLIVES Illustration has been reduced for printing purposes. Note: Authority cited: Sections 208, 26202 and 26510, Health and Safety Code. Reference: Sections 26556 and 26557, Health and Safety Code. s 16200. General Provisions. A manufacturer shall not mix a lot of a food containing defects exceeding the actionable level with another lot of food containing fewer defects than the actionable level. Such mixing renders the food actionable regardless of the defect level of the final food. Note: Authority cited: Sections 208, 26202 and 26203, Health and Safety Code. Reference: Sections 26203, 26520 and 26523, Health and Safety Code. s 16201. Heat Processed Canned Peaches: Actionable Defect Levels for Insects. (a) Definitions. (1) Standard Peach Unit means: (A) A single whole peach, or (B) A peach half, or (C) A number of pieces smaller than halves which taken together are equal in weight to a fraction of the drained weight according to can size as follows: Drained Weight or Drained Weight Fraction Equivalent to One Standard Can Size Peach Unit 8 oz. - 211x304...................................... 1/3 No. 300 - 300x407.................................... 1/6 No. 303 - 303x406.................................... 1/6 No. 2 - 307x409...................................... 1/8 No. 2 1/2- 401x411................................... 1/10 No. 10 - 603x700..................................... 1/40 No. 10 - 603x700 solid pack or preheated pie pack.... 1.5 oz. Larger than above sizes.............................. 1.5 oz. 1. The method of ascertaining drained weight shall be the method used for the USDA Quality Grade Standards for canned foods. (2) Insect infested means a standard peach unit having embedded or clinging insects or insect fragments. (b) Actionable levels for peaches which are principally peeled by hand, such as white peaches, are reached at any time when: (1) More than five percent of standard peach units by count are insect infested, or (2) More than twenty percent of the cans contain one or more free floating whole insect larvae, or the larval parts equivalent to a whole larva, or any free floating part of any adult insect. (c) Actionable levels for peaches which are not principally peeled by hand are reached at any time when: (1) More than one percent of standard peach units by count are insect infested, or (2) More than two percent of the cans contain one or more free floating whole insect larvae, or the larval parts equivalent to a whole larva, or any free floating part of any adult insect. (d)Sampling Requirements. (1) The minimum number of standard peach units and the minimum number of cans selected from a single manufacturer's lot for evaluation of compliance shall be determined according to can size as follows: Minimum Number of Minimum Standard Number Can Size Peach Units of Cans 8 oz. - 211/304...... 100 50 No. 300 - 200x407.... 100 25 No. 303 - 303x406.... 100 25 No. 2 - 307x409...... 125 25 No. 21/2- 401x411.... 200 25 No. 10 - 603x700..... 200 8 All Larger Cans...... 200 2 Note: Authority cited: Sections 208, 26202 and 26203, Health and Safety Code. Reference: Sections 26523 and 26524, Health and Safety Code. s 17000. Order Promulgating Regulations and Standards. Note: Authority cited for Article 14: Sections 26540 and 26540.2, Health and Safety Code. Reference: Secs. 26540.2 and 26542.1, Health and Safety Code. s 17001. Adoption and Application of Regulations and Standards. (a) Application. The Treasury Department regulations adopted and the exceptions and additional provisions in this Article shall be applicable to all the wine produced, imported, bottled, offered for sale or sold within the state for beverage use, or any other purpose, except as hereinafter provided. The production, the importation, or sale within this state of any product as, or under the designation of wine, which fails to conform to the applicable standard described herein, except for distillation into wine spirits or industrial or nonbeverage purposes is hereby prohibited. (b) Except as otherwise provided in this Article, the definitions and standards of identity and quality for wine and their amendments, now or hereafter promulgated by the U. S. Treasury Department, Internal Revenue Service, in Title 27 C.F.R., Part 4, Subparts B and C, Part 19, Subpart N, Part 231, Subpart F and Part 240, Subparts O, P, Q, R, S, T, V, W, X, Z, and ZZ, are the definitions and standards of identity and quality for wine in the State of California. Note: Authority cited: Sections 208, 26202 and 26515, Health and Safety Code. Reference: Section 26515, Health and Safety Code. s 17005. Standards of Identity and Quality for Wine Produced in California or Elsewhere. (a) The standards herein established are minimum standards for wine of the several classes and types defined. (b) Prohibited Wine. Wine derived from raisins, dried grapes, dried berries, and other dried fruit, and imitation or substandard wine, shall not be produced, imported, or sold in this state except for distillation into wine spirits or for industrial or nonbeverage purposes. (c) Cellar Treatment. Cellar treatment shall conform to the methods and materials authorized for treatment of wine by the Alcohol, Tobacco and Firearms Division of the Internal Revenue Service as well as the California Pure Foods Act and the Federal Food, Drug, and Cosmetic Act and the regulations adopted thereunder. In case of conflict between Federal and State laws or regulations the California law or regulation shall take precedence. Note: Authority cited: Sections 208, 26202 and 26215, Health and Safety Code. Reference: Section 26515, Health and Safety Code. s 17010. Provisions Applicable to Wine Produced in California. The following provisions shall apply to wines produced in California: (a) Sugar Use. No sugar, or material containing sugar, other than pure condensed grape must, and no water in excess of the minimum amount necessary to facilitate normal fermentation, may be used in the production or cellar treatment of any grape wine except: (1) In the production of sparkling wine (where sugar or liquid sugar may only be used in the traditional secondary fermentation and dosage), (2) Carbonated and special natural wine; provided, however, that sparkling and carbonated wine or the residuum thereof may be reconverted into still wine, and such wine and special natural wine or the residuum thereof may be distilled into wine spirits if the unfermented sugar has not been refermented. (3) Natural grape wine produced outside of the State of California with the use of sugar pursuant to applicable federal regulations may be blended with grape wine produced in California pursuant to these regulations only for the purpose of producing sparkling wine and carbonated wine. The resultant blend shall not be entitled to the appellation of origin "California" or any geographical subdivision thereof. (b) Sweetness Limitation. (1) The Brix saccharometer test, using a saccharometer calibrated at 20 degrees C and made in the presence of the alcohol content provided herein shall be: (A) Not less than 5.5 degrees for Angelica, Muscatel, Port and White Port. (B) Not less than 3.5 degrees for Tokay (as a dessert wine). (2) The reducing sugar content (per 100 milliliters at 20 degrees C and calculated as dextrose) for sherries shall be as follows: Minimum Maximum Dry Sherry............. 0.0 gram 2.5 grams Sherry................. 2.5 grams 4.0 grams Sweet, Golden, Cream or Mellow Sherry.......... 4.0 grams (c) Fixed Acidity. The minimum titratable fixed acidity per 100 milliliters at 20 degrees C for grape wine (except wine used solely for blending, medicinal or industrial purposes) calculated as tartaric acid, shall be as follows: red table wine...... 0.4 gram white table wine.... 0.3 gram all other wine...... 0.25 gram Note: Authority cited: Sections 208, 26202 and 26515, Health and Safety Code. Reference: Section 26515, Health and Safety Code. s 17015. Wines Bearing the Appellation of Origin "California" or a Geographical Subdivision Thereof. (a) A grape wine shall be entitled to the appellation of origin "California" or a geographical subdivision thereof only if: (1) 100 percent of its volume is derived from fermented juice of fruit grown within California; except that wine spirits produced in California from residues of wines, which contain grapes grown outside of California, may be used in the production of wines bearing the appellation of origin "California" or subdivisions thereof, subject to all of the following limitations: (A) The wine shall not derive more than 1 percent of its volume from fruit grown outside California. (B) The non-California portion shall be derived solely from residue wine spirits. (C) Grapes, juice, concentrate, wine or other distilling material shall not be imported into California for distilling of wine spirits for use under this Section, and (2) It has been fully produced and finished within the State of California, and (3) It conforms to the requirements of these regulations; provided, that no wine shall be entitled to an appellation of origin in violation of Section 25236 or Section 25237 of the California Alcoholic Beverage Control Act. Note: Authority cited: Sections 208, 26202 and 26515, Health and Safety Code. Reference: Section 26515, Health and Safety Code. s 17075. Labeling. (a) Certificate. The permittee responsible for labeling shall, upon request of the Department, furnish adequate proof that a valid certificate of label approval for all labels has been obtained from the U. S. Treasury Department and that such certificate is unrevoked at the time the wine is offered for sale; provided a wine shall not be deemed to be mislabeled, if its label fails to conform to the federal requirements only in those particular respects which are specifically authorized in this Article. (b) Service Containers. The prescribed mandatory information requirement shall not apply to containers used solely for service purposes, where such containers are filled on retail premises just before sale and for immediate use thereon. Note: Authority cited: Sections 208, 26202 and 26515, Health and Safety Code. Reference: Section 26515, Health and Safety Code. s 17076. Combination Wines. s 17090. Advertising of Wine. s 17100. Sanitation. s 17105. Enforcement. s 17116. Constitutionality. s 18000. California Brandy. (a) A grape brandy shall be entitled to the appellation "California" only if: (1) 100% of its volume is derived at the time of distillation from grapes grown within the State of California or from California wine and (2) It has been fully distilled within the State of California. Note: Authority cited: Sections 208 and 26514, Health and Safety Code. Reference: Section 26514, Health and Safety Code. s 19000. Order Promulgating Standards. Note: Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code. s 19001. Intent of Regulations. Note: Authority cited: Sections 208, 27010 and 27040, Health and Safety Code. Reference: Sections 27010 and 27040, Health and Safety Code. s 19005. Definitions. (a) "Complete food" means a nutritionally adequate pet food compounded by a specific formula to be fed as the sole ration and capable of maintaining life and/or promoting normal reproduction in healthy pets without any additional substance being consumed except water, based upon the recommendations of recognized authority in the field of animal nutrition. (b) "Balanced food" means a pet food having all known required nutrients in a proper amount and proportion based upon the recommendations of recognized authority in the field of animal nutrition for a given set of physiological animal requirements. (c) "Edible" as used in this article is to be construed as food fit to be eaten by dogs, cats, or other domestic animals. (d) "Meat" means the clean, wholesome flesh derived from slaughtered mammals and is limited to that part of the striated muscle which is skeletal or that which is found in the tongue, in the diaphragm, in the heart, or in the esophagus; with or without the accompanying and overlying fat, and the portions of skin, sinew, nerve and blood vessels which normally accompany the flesh. The term "meat" when applied to the corresponding portions of mammals other than cattle, swine, sheep and goats shall be used in qualified form, for example, "horsemeat." (e) "Meat by-products" is the non-rendered, clean, wholesome parts of the carcass of slaughtered mammals such as lungs, spleens, kidneys, brains, liver, stomach, bone, blood, and intestines free of their contents. It does not include skin, horns, teeth and hoofs. The term "meat by-products" when applied to the corresponding portions of mammals other than cattle, swine, sheep and goats shall be used in qualified form, as, for example, "horsemeat by-products." (f) "Poultry" means the eviscerated carcass of slaughtered poultry, exclusive of the head, feet and feathers. (g) "Poultry parts" means the clean, wholesome parts of dressed poultry characterized by large portions of bone such as necks, backs, and wings exclusive of feet, heads, viscera and feathers. (h) "Poultry by-products" means the non-rendered, clean parts of carcasses of slaughtered poultry such as heads, feet, and viscera free from fecal content and foreign matter, except in such trace amounts as might occur unavoidably in good factory practice. (i) "Giblet" means the edible heart, liver, and gizzard of poultry. (j) "Fish" means the fish and/or any part of fish used as a pet food ingredient with or without removal of entrails, head, tail and fins, except as provided in paragraph (k) of this section. (k) "Fish by-products" means the heads, fins, tail ends, bones, skin and viscera of fish. ( l "Fish meal" means the dried ground whole fish or fish cuttings, either or both, with or without extraction of part of the oil. (m) The common names and definitions of other ingredients used in the processing of pet foods shall be those recognized in the Official Publication of Feed Control by the Association of American Feed Control Officials (AAFCO) Incorporated and/or the U.S. Department of Agriculture. Note: Authority cited: Sections 208 and 27040, Health and Safety Code. Reference: Section 27040, Health and Safety Code. s 19010. Chemical Analysis. (a) All canned pet food shall comply with the following analysis: (1) Crude protein content -a minimum of 7 1/2 percent (2) Crude fat content -a minimum of 2 percent (3) Crude fiber content -a maximum of 1 1/2 percent (4) Moisture content -a maximum of 78 percent or the natural moisture content of the constituent ingredients of the product, whichever is greater. (b) All semi-moist pet food shall comply with the following analysis: (1) Crude protein content -a minimum of 12 percent (2) Crude fat content -a minimum of 5 percent (3) Crude fiber content -a maximum of 5 percent (4) Moisture content -a maximum of 65 percent (c) All dry pet food shall comply with the following analysis: (1) Crude protein content -a minimum of 18 percent (2) Crude fat content -a minimum of 4 percent (3) Crude fiber content -a maximum of 10 percent (4) Moisture content -a maximum of 18 percent Note: Authority cited: Sections 208 and 27040(a), Health and Safety Code. Reference: Sections 27033 and 27040, Health and Safety Code. s 19015. Exemptions. (a) Treats, candy and special diet for pets are exempt from the minimum and maximum requirements of the chemical analysis but shall comply with Section 19025, of this Article. (b) A processed pet food consisting entirely of gravy, sauce, broth or juice, when so labeled, is exempt from the requirements of paragraphs (a), (b), and (c) of Section 19010 and paragraph (b) of Section 19025 of this Article. Note: Authority cited: Sections 208 and 27040(a), Health and Safety Code. Reference: Sections 27033 and 27040(a), Health and Safety Code. s 19020. Required Verifications. (a) Prior to offering a processed pet food for sale in California, each pet food manufacturer shall submit in triplicate to the Department, the following: (1) A complete list of the pet food ingredients by their common or usual name, and in order of their predominance by weight. The percentage of each ingredient derived from mammals, poultry, or fish shall be stated for each formula when the product is as defined in Section 19025, paragraphs (i), (j), (k), and ( l) of this Article. (2) copies of each label for all processed pet foods. (b) Manufacturers of processed pet foods shall, upon request, supply verification of formulas, and/or flavor ingredients or claims to the State Department of Public Health. Note: Authority cited: Sections 208 and 27040, Health and Safety Code. Reference: Sections 27031, 27032, 27033, 27034 and 27040(a) and (d), Health and Safety Code. s 19025. Labeling and Restrictions. (a) The words "dog food," "cat food," or similar designations shall appear conspicuously upon the principal display panels of the pet food labels. (b) The following shall appear on the label: "Guaranteed Analysis" Crude protein -minimum % Crude fat -minimum % Crude fiber -maximum % Moisture -maximum % Additional guarantees, if any, shall follow crude fiber. (c) The ingredients used in the manufacture of the processed pet food shall be listed in the ingredient statement on the label by their common or usual name as defined in Section 19005 of this Article in their descending order of predominance by weight. When water is added in the preparation of a processed pet food, a statement of that fact, for example, "sufficient water has been added for processing," may appear at the conclusion of the ingredient list. (d) No product or any of its wrappers, packaging or other containers shall bear any false or misleading marking, label or other labeling, and no statement, word, picture, design, or device which gives a false indication of origin, quality or flavor. No product shall be wholly or partly enclosed in any wrapper, packaging or other container that is so made, formed, or filled as to be misleading. (e) All labels shall also comply with the provisions of Sections 27031, 27032, 27033, and 27034 of the California Health and Safety Code and the U.S. Fair Packaging and Labeling Act. (f) A processed pet food shall not be labeled a specific flavor unless a sufficient amount of that ingredient is used to impart such characteristic flavor and/or odor to the finished product which is detectable by a recognized test method, or is one the presence of which provides a characteristic distinguishable by the pet. Any flavor designation on a pet food label must either conform to the name of its source as shown in the ingredient statement or the ingredient statement shall show the source of the flavor. (g) The terms "fit for human food," "fit for human consumption," or any similar terms are prohibited on the labels or in advertisements of a processed pet food. (h) The name of the processed pet food shall not be derived from one or more ingredients of a mixture to the exclusion of other ingredients and shall not be one representing any components of a mixture of a pet food product unless all components or ingredients are included in the name except as specified in paragraphs (f), (i), (j), (k) and ( l) of this section; provided, that if any ingredient or combination of ingredients is intended to impart a distinctive characteristic to the product which is significant to the purchaser, the name of that ingredient or combination of ingredients may be used as a part of the name of the pet food if: (1) the ingredient or combination of ingredients is present in sufficient quantity to impart a distinctive characteristic to the product; (2) it does not constitute a representation that the ingredient or combination of ingredients is present to the exclusion of other ingredients; and (3) it is not otherwise false or misleading. (i) When an ingredient or a combination of ingredients derived from mammals, poultry, or fish constitutes 95% or more of the total weight of all ingredients of a pet food mixture, the name or names of such ingredient(s) may form a part of the product name of the pet food, provided that where more than one such ingredient is part of the product name, then all such ingredient names shall be in the same size, style, and color print on the front panel of the label, in their descending order of predominance by weight. (j) When an ingredient or a combination of ingredients derived from mammals, poultry, or fish constitutes 50% or more of the total weight of all ingredients of a pet food mixture, the name or names of such ingredient(s) may form a part of the product name of the pet food, when the product name also includes a descriptive term "with gravy," "with sauce," or similar connotation which will fully describe the contents of the pet food mixture. All such ingredient name(s) shall be in descending order of predominance by weight. The ingredient name(s) shall be in the same size, style, and color print on the front panel of the label and the descriptive term shall follow immediately after or below the ingredient name(s) in conspicuous size lettering in the same style and color print. (k) When an ingredient or a combination of ingredients derived from mammals, poultry, or fish, constitutes 25% or more of the total weight of all ingredients of a pet food mixture, the name or names of such ingredient or ingredients may form a part of the product name of the pet food only if the product name also includes a primary descriptive term such as "balls," "cakes," "loaf," "croquettes," or "stew," so that the product name describes the contents of the product in accordance with an established law, custom, or usage, or so that the product name is not misleading. All such ingredient names and the primary descriptive term shall be in the same size, style and color print. ( l) A product shall not be described on the label or in advertising as "all meat" or "100% meat" or "all tuna" or "all chicken" or otherwise represented as being composed wholly of a named ingredient if it contains other added ingredients such as the by-products of meat, poultry, or fish. However, for the purpose of this provision, water sufficient for processing, required denaturing agents, and trace amounts of preservatives and condiments shall not be considered ingredients. (m) Terms such as "burger," "chunk," "patty," "cube," "loaf," "croquette" and other of similar import, shall not be used to describe a product or an ingredient thereof which does not have substantially the shape or form so represented when it is sold to the retail purchaser. (n) The names of ingredients shall not be used in advertising, labeling, brand or trade name, or otherwise, so as to misrepresent directly or by implications the identity of an ingredient or the composition of a processed pet food. (o) A vignette, graphic, or pictorial representation of a product on a processed pet food label shall not misrepresent the contents of the package. (p) Inspection Legend. Upon receipt of written permission from the Department, the following statement may be placed on the labels or can end of pet food packed in compliance with the provisions of the Laws Relating to Cannery Inspection: "STERILIZED UNDER THE SUPERVISION OF AND ACCORDING TO THE REGULATIONS OF THE CALIFORNIA STATE DEPARTMENT OF HEALTH SERVICES." Note: Authority cited: Sections 208 and 27040(a), (b) and (d), Health and Safety Code. Reference: Sections 27031, 27032, 27034 and 27040, Health and Safety Code. s 19030. Manufacturing Requirements. (a) Pet food ingredients used to manufacture a processed pet food shall be sound, clean, and wholesome and shall conform to the provisions of the California Pure Pet Food Act of 1969. (b) All stomachs, intestines, and/or other such by-products, which are used in the manufacture of processed pet food, shall be thoroughly washed and inspected for fecal or foreign contamination. (c) Meat meal, meat and bone meal, meat scraps, and other similar meat products may be used only if they have been produced in a plant approved by a federal, state, or municipal inspection agency. (d) All processed pet food packed in hermetically sealed containers shall be processed in such a manner as to achieve commercial sterility in all units packed. (e) All processed pet food not packed in hermetically sealed containers shall be processed so as to render the product free of salmonella, or other pathogenic microorganisms which are transmissible to man or animal. Note: Authority cited: Sections 208 and 27040(c), Health and Safety Code. Reference: Sections 27030 and 27040(c), Health and Safety Code. s 19035. Magnet to Remove Ferrous Material. (a) All pet food processors are hereby required to install between the cooker and the filling machine a magnetic separator with a holding power of not less than 125 pounds per square inch to remove ferrous material. The magnetic exposure area shall be not less than 6 inches by 10 inches. (1) The magnet shall be so installed that the material to be processed shall pass the magnet in a relatively thin stream. (2) If an electro-magnet is used it shall be fitted with a trap to prevent any material already removed from passing to the filler, in the event of a power failure. The switch operating an electro-magnet shall be equipped with a red signal light. (b) A magnetic separator specified in Section 19035(a) is not required if it is demonstrated to the Department's satisfaction that equivalent protection is being provided by the use of other methods or devices. Note: Authority cited: Sections 208 and 27040(c), Health and Safety Code. Reference: Sections 27030 and 27040(c), Health and Safety Code. s 19040. Arsenic and Lead Tolerance in Animal Food. The tolerance for arsenic in processed pet food is established at 1/20 (0.05) grain per pound and for lead at 1/60 (0.0167) grain per pound. Note: Authority cited: Sections 208 and 27040(c), Health and Safety Code. Reference: Sections 27030 and 27040(c), Health and Safety Code. s 19041. Pet Food Licenses and Certificates. (a) Licenses and certificates for pet food processors will be valid for a two-year period from date of issue and are not transferable. The fee for the license or certificate is $200.00. (b) Application for a Processed Pet Food license or certificate shall be made on State Department of Health form #446-129 or #446-130 respectively. (c) The fee shall accompany the application and shall not be refundable. (d) The licensee shall immediately notify the Department of any change in the information which was submitted on the license or certificate application. Note: Authority cited: Sections 208 and 221, Health and Safety Code. Reference: Section 221, Health and Safety Code. s 19043. Sources of Poultry Meat. Only poultry meat or poultry product from state or federally inspected poultry processing plants may be used in animal foods. Note: Authority cited: Sections 208, 26202, 26510 and 27040, Health and Safety Code. Reference: Sections 27033, 27040 and 27041, Health and Safety Code. <<(Subchapter Originally Printed 5-14-49)>> Note: Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code. 1. News 30001-30053, inclusive, filed 5-3-49 (Register 16, No. 3). 2. Repealer of Group 1 (Articles 1-7, Sections 30001-30053, not consecutive) filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6). s 30001. Certified Technician. "Certified Technician" means any employee of a vector control agency who has passed the Department's certification examination as specified in section 30055 and is required by section 30061 to obtain continuing education units in order to independently handle, apply, or supervise the application of any pesticide as part of such employee's official duties. Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30003. Certified Technician (Limited). "Certified Technician (Limited)" means any employee of a vector control agency who has passed the Department's certification examination as specified in section 30055, but who is exempt under section 30061 from continuing education requirements. A Certified Technician (Limited) may not handle or apply a pesticide as part of his or her official duties except under the direct supervision of a Certified Technician, or as permitted under section 30061(d). Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30005. Continuing Education Unit. "Continuing Education Unit (CEU)" means a unit value assigned to educational activities approved by the Department equal to one unit for each 50 to 60 minute segment of instruction as determined by the Department. Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30007. In-Service Training. "In-Service Training" means training given within an agency on subjects directly related to vector control duties. Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30009. Pesticide Label. "Pesticide Label" means the written, printed or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers. Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30011. Relevant Vectors. "Relevant Vectors" means those vectors normally included within a group of vectors falling within the category of each vector control certificate and which employee of a vector control agency may be expected to control when working within a particular certificate specialty. Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30013. Under the Direct Supervision of. "Under the Direct Supervision of" means the act or process whereby a pesticide is applied by a Certified Technician (Limited) or a Vector Control Aide acting under the instructions and control of a Certified Technician who is responsible for the actions of that person and who is available if and when needed even though such certified technician is not physically present at the time the pesticide is applied. A Certified Technician shall be physically present during the application of a pesticide when required by the pesticide label. Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30015. Vector. "Vector" means any animal that meets the definition of section 402.1 of the Health and Safety Code. Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30017. Vector Control Aide. "Vector Control Aide" means a person who is employed by a vector control agency but is not certified under Section 30055 and may not handle or apply a pesticide as part of his or her official duties except under the direct supervision of a Certified Technician or as permitted under section 30061(d). Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30019. Vector Control Agency. "Vector Control Agency" means any government agency, including but not limited to a mosquito abatement district, vector control district, pest abatement district, environmental health department, or public health department, which conducts an ongoing program within its jurisdiction to reduce vector populations in order to protect the public health and well-being. Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code. s 30054. Definitions. Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Reference: Sections 402(d) and 402.1, Health and Safety Code. s 30055. Examination Requirements. Any person employed by a vector control agency as a Certified Technician or Certified Technician (Limited) shall pass, with a score of 70 percent or higher, the Public Health Pest Control Certified Technician Examination administered by the Department. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 402(d), 403, 2202 and 2805, Health and Safety Code. s 30056. Examination Content. (a) The written examination for certification of vector control agency personnel shall consist of questions covering the following areas: (1) Label and labeling comprehension -factors including: (A) The general format and terminology of pesticide labels and labeling; (B) The understanding of instructions, warnings, terms, symbols, and other information commonly appearing on pesticide labels; (C) Classification of the product, general or restricted; and (D) Necessity for use consistent with the label. (2) Safety -factors including: (A) Pesticide toxicity and hazard to man; (B) Common exposure routes; (C) Common types and causes of pesticide accidents; (D) Precautions necessary to guard against injury to applicators and other individuals in or near treated areas, including medical supervision; (E) Need for and use of protection clothing and equipment; (F) Symptoms of pesticide poisoning; (G) First aid and other procedures to be followed in case of a pesticide accident; and (H) Safe and proper procedures for identification, storage, transport, handling, mixing of pesticides and disposal of pesticides and used pesticide containers, including precautions to prevent access by children. (3) Environment -The potential environmental consequences of the use and misuse of pesticides as may be influenced by such factors as climate and weather, non-target organisms, and drainage patterns. (4) Vectors -factors such as: (A) A knowledge of relevant vectors and their distribution; (B) Recognition of relevant vectors by distinguishing features of the vector organisms and/or characteristics of damage or other signs; (C) Vector development and biology (life cycles) relevant to identification and control; (D) Public health importance of relevant vectors, including a practical knowledge of vector-borne disease transmission, as it relates to and influences control programs; and (E) Habitats where relevant vectors occur, including a practical knowledge of those environments. (5) Pesticides -factors such as: (A) Types of pesticides; (B) Types of formulations; (C) Characteristics of pesticides and formulations, including compatibility, synergism, persistence, and animal and plant toxicity; (D) Hazards and residues associated with use, including applicable laws and regulations; (E) Factors which influence effectiveness or lead to such problems as resistance to pesticides; and (F) Dilution procedures. (6) Pesticide application equipment and techniques -factors including: (A) Types of equipment and their uses, advantages, and limitations; (B) Maintenance of equipment; (C) Calibration of equipment; (D) Operating procedures and techniques used to apply various formulations of pesticides; (E) A knowledge of the most effective equipment and technique of application to use in a given situation; (F) Relationship of discharge and placement of pesticides to proper use, unnecessary use, and misuse; and (G) Prevention of drift and pesticide loss into the environment. (7) Non-chemical control methods -A practical knowledge of the importance and use of such methods as sanitation, waste management, drainage, exclusion, trapping, public education, and legal abatement . (8) Record Keeping -A familiarity with the principles and practices of biological and operational documentation. (9) Supervisory Requirements -A practical knowledge of State and Federal supervisory requirements, including labeling, regarding the application of restricted materials by a technician's aide. (10) Laws and Regulations -A basic knowledge of applicable State and Federal laws and regulations. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 1800-1813 and 2200-2910, Health and Safety Code. s 30056.1. Interpretation of Dates. For purposes of this Article: (a) Submission of an application shall be deemed to occur on the date the application form is received by the Department. (b) Filing of a completed application shall be deemed to occur when all information required to be submitted on an application form has been received by the Department. (c) Written notifications by the Department to applicants shall be deemed to occur on the date the notifications are postmarked. Note: Authority cited: Sections 208 and 402, Health and Safety Code; and Sections 15376 and 15378, Government Code. Reference: Sections 15376 and 15378, Government Code. s 30056.2. Applications. (a) To apply for admission to the Public Health Pest Control Certified Technician Examination, the applicant shall complete an Application for Admission to the Public Health Pest Control Certified Technician Examination, FORM EH 173 (2/88). The application form shall include the applicant's name and job title, the employing agency's name and address, and the signatures of the applicant and the agency administrator. The form shall be completed, signed, and submitted in accordance with directions printed on or provided with the form. (b) Within 14 calendar days after submission of an application for admission to the examination, the Department shall notify the applicant in writing, through the vector control agency where the applicant is employed, that the application is complete and accepted for filing, or that the application is deficient, and what specific information is required to complete the application. Notification of acceptance shall be in the form of a copy of the application form, marked "approved," which shall be returned to the applicant. If deficient, the entire application shall be returned to the applicant. Note: Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code. s 30056.3. Admission to Examination. Admission to an examination shall be permitted upon presentation by the applicant of an approved copy of the application form, as provided pursuant to Section 30056.2(b). Note: Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code. s 30056.4. Notification of Examination Results. The Department shall notify the applicant in writing, through the vector control agency where the applicant is employed, of the examination result and decision on the certification, within 118 calendar days after the filing of a completed application. Note: Authority cited: Sections 208 and 402, Health and Safety Code; and Section 15376, Government Code. Reference: Section 15376, Government Code. s 30056.5. Processing Times. The Department's minimum, maximum, and median time periods for processing a certificate, from the receipt of the initial applications to notification of the final certification decision regarding results of the examination for certification, based on the Department's actual performance during the two years immediately preceding the proposal of this regulation, were as follows: (a) The median time was 54 calendar days. (b) The minimum time was 50 calendar days. (c) The maximum time was 118 calendar days. Note: Authority cited: Sections 208 and 402, Health and Safety Code; and Section 15376, Government Code. Reference: Section 15376, Government Code. s 30057. Expiration. Note: Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code. s 30058. Denial, Suspension, or Revocation. (a) The Director may deny, suspend, or revoke any certificate for any of the following reasons: (1) Failure to adequately supervise the use of a restricted material. (2) Failure to obtain a restricted material permit when required. (3) Failure to comply with any applicable provision of Divisions 6 or 7 of the Food and Agricultural Code or regulations adopted pursuant to such provisions. (4) Failure to record each restricted material use and submit such record as required by law or regulations. (5) Making any false or fraudulent record. (6) Operating in a faulty, careless, or negligent manner. (7) Failure to qualify by examination. (b) Any action to deny, suspend or revoke such certificate shall be heard under the Administrative Procedure Act, Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code; provided, however, if the Director finds that the protection of the public welfare or safety requires immediate action, he or she may, without hearing, temporarily suspend or condition the certificate and shall forthwith schedule the matter for hearing. The Director may terminate such temporary suspension or condition upon corrective action as he or she deems satisfactory to assure compliance with the requirements of the law and the regulations. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 1800-1813 and 2200-2910, Health and Safety Code. s 30059. Records. Note: Authority cited: Sections 208 and 402, Health and Safety Code. Reference: Section 402, Health and Safety Code. s 30061. Continuing Education Requirements. (a) Except as provided in (d), any employee of a vector control agency who independently handles, applies, or supervises the application of any pesticide as part of his or her official duties shall obtain the following continuing education units (CEU) within each two year period following initial date of certification: (1) Minimum Prerequisite CEU for all specialty certificates: (A) Pesticide use and safety -ten CEU. (B) Animal biology and ecology -two CEU. (C) In-service training -four CEU. (2) Additional minimum CEU for each specialty certificate: (A) Mosquito Control -six CEU on mosquitoes and two CEU on other aquatic invertebrates and their control. (B) Terrestrial Invertebrate Control -six CEU on domestic flies, fleas, and ticks; two CEU on other terrestrialinvertebrate vectors, and their control. (C) Vertebrate Control -eight CEU on rodents and on other vertebrate vectors, and their control. (b) Failure to attain minimum CEU in any specialty area shall result in the down-grading of certification in the specialty in which the Certified Technician is delinquent, to the Certified Technician (Limited) status. (c) Reinstatement to Certified Technician status shall be subject to the approval of the Department upon proofof minimum CEU and proof of payment of all current fees. (d) The foregoing continuing education requirements are not applicable to the following: (1) Employees who use insignificant amounts of compounds commonly used for pest detection during inspections. (2) Persons who do not handle, apply, or supervise the application of any pesticides for public health purposes. (3) Employees involved only in research and development of public health pesticides. Note: Authority cited: Sections 208, 2202 and 2805, Health and Safety Code. Reference: Sections 402(d), 403, 2202 and 2805, Health and Safety Code. s 30062. Definitions. The following definitions shall apply to this subchapter: (a) "Local agency" means a county which has established an emergency mosquito abatement trust account pursuant to Article 4 (commencing with Section 25850) of Chapter 8 of Part 2 of Division 2 of Title 3 of the Government Code; or a mosquito abatement district or vector control district which has established an emergency mosquito abatement trust fund pursuant to Article 5.1 (commencing with Section 2315) of Chapter 5 of Division 3 of the Health and Safety Code; or a pest abatement district which has established an emergency mosquito abatement trust fund pursuant to Article 4.1 (commencing with Section 2877) of Chapter 8 of Division 3 of the Health and Safety Code. (b) "Threat to the public health and safety" means the actual or scientifically predictable presence of mosquitoes in such numbers that, in the judgment of the Department, there is a strong probability that: (1) Mosquitoborne pathogens will be transmitted to humans; or (2) There will be substantial interference with the normal enjoyment of life or property by an entire community or neighborhood, or by any considerable number of persons. Note: Authority cited: Section 25852(e), Government Code; and Sections 208 and 2317(e), Health and Safety Code. Reference: Section 2317(d), Health and Safety Code; and Section 25852(d), Government Code. s 30064. Application for Expenditure. (a) When a local agency applies to the Department for authority to expend any portion of the principal of the emergency mosquito abatement trust account (if the local agency is a county) or emergency mosquito abatement trust fund (if the local agency is a mosquito abatement district, vector control district, or pest abatement district) it shall apply for the expenditure in writing, by telephone, or other rapid means, but shall confirm in writing within 3 working days. (b) The application for expenditure shall include the following: (1) Whether the imminent threat to the public health and safety is due to either an actual outbreak or to an expected outbreak of mosquitoes, or both; (2) The mosquito species involved; (3) Other areas involved; (4) The specific control actions proposed; (5) The approximate dates of the proposed actions; (6) The name of the person who will supervise the proposed actions and the vector control certificates or licenses possessed by that person; and (7) The amount of the principal proposed to be expended. Note: Authority cited: Section 25852(e), Government Code; and Sections 208 and 2317(e), Health and Safety Code. Reference: Section 2317(d), Health and Safety Code; and Section 25852(d), Government Code. s 30066. Criteria for Emergency Mosquito Abatement Procedures. The emergency mosquito abatement procedures shall be adequate if: (a) The local agency's program is under the direct supervision of: (1) A technician certified in mosquito control pursuant to Section 402 of the Health and Safety Code; or (2) Any person who is licensed in health-related pest control pursuant to Chapter 1 (commencing with Section 11401) and Chapter 2 (commencing with Section 11501) of Division 6 of the Food and Agricultural Code; and (b) The Department finds that the proposed emergency mosquito abatement procedures are proven effective in the reduction of the imminent threat to the public health and safety. Note: Authority cited: Sections 208 and 2317(e), Health and Safety Code; and Section 25852(e), Government Code. Reference: Section 2317(e), Health and Safety Code; and Section 25852(e), Government Code. s 30070. Purpose and Scope. These regulations are intended to provide safeguards for the protection of persons in the State of California from disease hazards associated with imported wild animals. The regulations apply to all persons, including but not limited to the following: educational and research institutions, zoological gardens, schools, colleges, universities, pet stores, animal care facilities, and laboratories, who import, hold, sell, purchase or possess any wild animal for which an import permit is required under the provisions of Chapter 14, Division 20, California Health and Safety Code. Note: Authority cited: Sections 102, 208 and 25990.5, Health and Safety Code. Reference: Sections 25990 through 25994.8, Health and Safety Code. s 30071. Definitions. For the purposes of these regulations: (a) "Person" means any person, firm, association, organization, partnership, business trust, corporation, or company. (b) "Department" means the State Department of Health Services. (c) "Animal" means any wild animal or bird specified by the Department under provisions of Chapter 14, Division 20, of the Health and Safety Code. (d) "Veterinarian" means a person authorized to practice veterinary medicine under provisions of Chapter 11, Division 2, California Business and Professions Code. (e) "Standards" means the requirements with respect to the quarantine housing, handling, care, treatment, and transportation of imported animals. (f) "Primate" means a nonhuman member of the highest order of mammals, including prosimians, monkeys, and apes as specified in Section 30072. (g) "Euthanasia" means the humane destruction of an animal accomplished by a method that involves instantaneous unconsciousness and immediate death or by a method that involves anesthesia, produced by an agent which causes painless loss of consciousness, and death during such loss of consciousness. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Section 25990.5, Health and Safety Code. s 30072. Wildlife Admitted by Permit. No person shall import into or receive in this State any animals of the following orders, families, and genera specified herein without first obtaining a permit and paying to the Department such fees as required under these regulations. (a) Birds (Class Aves). Admissible without permit from the department. (b) Mammals (Class Mammalia (1) Primates (Order Primates -Members of the following families, all genera therein: Family Lorisidae, Genus Loris (Slender Loris), Genus Nycticebus (Slow Loris), Genus Arctocebus (Golden Potto), Genus Perdicticus (Potto), Genus Galago (Galago), and Genus Euoticus (Needle-clawed Galago). Family Callithricidae, Genus Callithrix (Short-tusked Marmoset), Genus Cebuella (Pygmay Marmoset), Genus Saguinus (Long-tusked Marmoset), and Genus Leontideus (Lion-headed Marmoset). Family Cebidae, Genus Aotus (Douroucoulis), Genus Callicebus (Titi Monkey), Genus Cacajao (Ukari), Genus Pithecia (Saki), Genus Chiropotes (Red-backed Saki), Genus Alouatta (Howler Monkey), Genus Cebus (Capuchin), Genus Saimiri (Squirrel Monkey), Genus Ateles (Spider Monkey), Genus Brachyteles (Woolly Spider Monkey), Genus Lagothrix (Woolly Monkey), and Genus Callimico (Goeldi's Marmoset). Family Cercopithecidae, Genus Macaca (Macaque), Genus Cynomacaca (Celebes Macaque), Genus Cynopithcus (Celebes Crested Macaque), Genus Cercocebus (Mangabey), Genus Chaeropithecus (Baboon), Genus Comopithecus (Hamadryas Baboon), Genus Mandrillus (Mandrill), Genus Theropithecus (Gelada Baboon), Genus Cercopithecus (Guenon), Genus Miopithecus (Talapoin Monkey), Genus Allenopithecus (Allen's Monkey), Genus Erythrocebus (Patas Monkey), Genus Presbytis (Langur), Genus Pygathrix (Douc Langur), Genus Rhinopithecus (Snub-nosed Langur), Genus Simias (Mentawi Islands Snub-nosed Langur), Genus Nasalis (Proboscis Monkey), and Genus Colobus (Colobus Monkey). Family Pongidae, Genus Hylobates (Gibbon), Genus Symphalangus (Siamang Gibbon), Genus Pongo (Orangutan), Genus Pan (Chimpanzee), and Genus Gorilla (Gorilla). (2) Carnivores (Order Carnivora -Members of the following families, all genera therein unless otherwise noted: (A) Family Felidae, genus Felis and genus Panthera, consisting of New World species: F. pardalis (Ocelot), F. wiedii (Margay), F. tigrina (Little Spotted Cat), F. colocolo (Pampas Cat), F. geoffroyi (Geoffroy's Cat), F. guigna (Kodkod), F. jacobita (Gato Andina), F. yagouaroundi (Jaguarundi), and P. onca (Jaguar). All other members of the family Felidae are admissible without permit from the Department. (B) Family Canidae, genus Aopex (Arctic Fox), genus Vulpes (Red or Kit Fox), genus Urocyon (Gray Fox), and genus Canis, including all species other than Canis familiaris (the domestic dog). All other members of the family Canidae are admissible without permit from the Department. (C) Family Procyinidae, genus Bassariscus (Ring-Tailed Cat) and genus Procyon (Raccoon). All other members of the family Procyinidae are admissible without permit from the Department. (D) Family Musteldae, genus Mephitis (Striped Skunk) and genus Spilogale (Spotted Skunk). All other members of the family Musteldae are admissible without permit from the Department. (3) Bats (Order Chiroptera -Members of all families, all genera therein. Note: Reference should also be made to statutory provisions of the California Fish and Game Code and the joint regulations of the Fish and Game Commission and the California Department of Agriculture. Where question exists regarding the importation into and the keeping of live wild birds, mammals, amphibians, reptiles, crustaceans and fish in California, representatives of the Department of Fish and Game should be consulted. Note: Authority cited: Sections 208, 25990.3 and 25990.5, Health and Safety Code. Reference: Sections 25990.3 and 25990.5, Health and Safety Code. s 30073. Application for Import Permits. Import permits for animals listed under Section 30072 shall be issued only upon written application from the person desiring to import them. The application shall include but not be limited to the following: (a) The number, common name, and true scientific name of each species (Example reference: Walker, E. P., and others. Mammals of the World. Baltimore, Johns Hopkins Press, 1975. Volumes I and II). (b) The carrier and probable point of first arrival in this state of each shipment. (c) The purpose for which they are to be imported (exhibition, research, sale to the public, etc.). (d) The name and address of the consignee. (e) The name and address of the consignor. (f) The place or premise where the animals shall be held in quarantine pending the completion of such tests, veterinary examinations, and observation period as may be specified by the department in issuance of import permit. Adequate quarantine facilities must be available and approved by the department before issuance of the import permit can be made (See Sections 30077 and 30077.1). (g) The name and address of the veterinarian who shall conduct the tests and examinations specified by the department. (h) For personal pets only, the date of acquisition and name and address of supplier. Note: Authority cited: Sections 208, 25990.5 and 25992.3, Health and Safety Code. Reference: Sections 25992 and 25992.3, Health and Safety Code. s 30073.1. Determination of Application Completeness and Notification. (a) Within 15 calendar days of receipt of an application for a wild animal importation permit, or a request for permit modification, the Department shall inform the applicant in writing either that the application is complete and accepted for filing, or that it is deficient and identify the additional specific information necessary for the application to be complete. (b) The date on which the application is determined complete for filing, or on which the application is determined deficient shall be the date on which the Department's written notification to the applicant is postmarked. Note: Authority cited: Section 15376, Government Code; and Sections 208 and 25992, Health and Safety Code. Reference: Section 15376, Government Code; and Section 25992, Health and Safety Code. s 30073.2. Application Time Periods for Processing a Permit Based on Actual Performance. (a) The Department's time periods for processing a wild animal importation permit application, or a wild animal quarantine facility approval application, from the receipt of the initial application to the final decision regarding the permit or approval, are as follows: (1) The median time for processing is: (A) 10 calendar days for an importation permit application. (B) 90 calendar days for a quarantine facility approval application. (2) The minimum time for processing is: (A) 5 calendar days for an importation permit application. (B) 60 calendar days for a quarantine facility approval application. (3) The maximum time for processing is: (A) 15 calendar days for an importation permit application. (B) 180 calendar days for a quarantine facility approval application. Note: Authority cited: Section 15376, Government Code; and Sections 208 and 25992, Health and Safety Code. Reference: Section 15376, Government Code; and Section 25992, Health and Safety Code. s 30074. Issuance of Import Permits. Issuance of import permits for animals listed under Section 30072 may be made by the Department upon: (a) Submission of written application providing the information enumerated under Section 30073 not less than seven (7) days preceding the probable date of shipment, and (b) if necessary, submission of a written application for Department approval of the wild animal quarantine facility, completion of an on-site inspection, and final approval of the quarantine facility or premise designated in the permit application, and (c) payment of the necessary permit fees required under Section 25992.8 of the Health and Safety Code and set forth under Section 30076 of these regulations, and (d) determination by the Department that the public health and safety is not endangered, and (e) approval of the probable point of first arrival into this State. Note: Authority cited: Sections 208, 25990.5, 25992.3 and 25992.8, Health and Safety Code. Reference: Sections 25990.5, 25992, 25992.3 and 25992.8, Health and Safety Code. s 30074.1. Importation of Animals Under Special Permit. Permits not requiring the quarantine of imported wild animals may be issued by the Department under the following special conditions: (a) Short-Term Exhibition of Captive Born and Raised Nonhuman Primates Having No Contact With the Public. Animals subject to these provisions (as specified under Section 30072) may be brought into the State for short-term nonresident exhibition purposes (e.g., circuses) under a short-term exhibition permit issued by the Department upon application for the permit and payment of a $10.00 permit fee per animal. Persons wishing to import or receive nonhuman primates for short-term exhibition purposes under this subsection shall provide the Department with documentation of the following: (1) A health history on the animal, or the parents of animals less than six months of age, for the 180 days prior to importation, and (2) The animal(s) are captive born and raised, and (3) How the animal(s) will be maintained in a manner approved by the Department to prevent direct physical contact with the public, and (4) A veterinary health certificate issued not more than 30 days before importation certifying that the animal has been examined by a veterinarian accredited by the United States Department of Agriculture and is free of signs of contagious or infectious diseases. (b) Short-Term Exhibition of Captive Born and Raised Nonhuman Primates Having Direct Contact With the Public. Animals subject to these provisions (as specified under Section 30072) may be brought into the State for nonresident exhibition purposes under a short-term exhibition permit issued by the Department upon application for a permit and payment of a $10.00 permit fee per animal. Persons wishing to import or receive short-term exhibition nonhuman primates into the State where the animal(s) will have direct contact with the public shall provide the Department with documentation of the following: (1) A health history on the animal, or the parents of animals less than six months of age, for the 180 days prior to importation, and (2) The animal(s) are captive born and raised, and (3) How the animal(s) will be maintained in a manner approved by the Department to prevent direct physical contact with the public at all times except when being exhibited, and (4) A veterinary health certificate issued not more than 30 days before importation certifying that the animal has been examined by a veterinarian accredited by the United States Department of Agriculture and is free of signs of contagious or infectious diseases. (5) A negative tuberculin skin test performed on the animal(s) not more than 30 days before importation. (c) Short-Term Exhibition of Captive Born and Raised Carnivores. Animals subject to these provisions (as specified under Section 30072) may be brought into the State for short-term nonresident exhibition purposes (e.g., circuses) under a short-term exhibition permit issued by the Department upon application for the permit and payment of a $10.00 permit fee per animal. Persons wishing to bring short-term exhibition carnivores into the State shall provide the Department with documentation of the following: (1) A health history on the animal, or the parents of animals less than six months of age, for the 180 days prior to importation, and (2) The animal(s) are captive born and raised, and (3) How the animal(s) will be maintained in a manner approved by the Department to prevent direct physical contact with other animals or the public, and (4) A veterinary health certificate issued not more than 30 days before importation certifying that the animal has been examined by a veterinarian accredited by the United States Department of Agriculture and is free of signs of contagious or infectious diseases. (d) Zoological exhibition of specified wild animals. (1) Animals subject to these provisions as specified under Section 30072 may be brought into the State for exhibition in a zoological collection accredited by the American Association of Zoological Parks and Aquariums (AAZPA) under a zoological exhibition permit issued by the Department upon payment of a $10.00 permit fee per animal. AAZPA accredited organizations wishing to import or receive specified wild animals for zoological exhibition purposes under this subsection shall provide the Department with documentation of the following: (A) The animal(s) are captive born and raised, or have been in the possession of the consignee for at least 180 days prior to importation, and (B) the animal(s) are being imported from an AAZPA-accredited zoological collection, and (C) a health history on the animal or the parents of the animals less than six months of age, for the 180 days prior to importation, and (D) a veterinary health certificate issued not more than 30 days before importation certifying that the animal has been examined by a veterinarian accredited by the United States Department of Agriculture and is free of signs of contagious or infectious diseases. (E) A negative tuberculin skin test performed on all nonhuman primates not more than 30 days before importation. (2) Nonhuman primates imported under this subsection shall be kept in isolation for 30 days immediately following importation. The animal(s) shall be tested if necessary for enteric pathogens during isolation. If at the end of the 30 days, the animal(s) are tuberculin skin tested with negative results, are examined and issued a health certificate by an accredited veterinarian certifying that the animal(s) are healthly and free of signs of contagious or infectious diseases, the animal(s) may be released by the Department upon review of isolation records. (3) Carnivores or Chiroptera specified in Section 30072 imported under this subsection shall be kept in isolation for 90 days immediately following importation. If at the end of the 90 days, the animal(s) are examined and issued a health certificate by an accredited veterinarian certifying that the animal(s) are healthy and free of signs of contagious or infectious diseases, the animal(s) may be released by the Department upon review of isolation records. (e) Animal Breeding. Animals being moved for breeding purposes as part of a recognized animal colony established for experimental breeding of animals in captivity, may be moved for this purpose upon issuance of a fee exempt permit provided that the conditions specified by the Department in the permit are adhered to in full. (f) Animal(s) permitted entry under subsection 30074.1(a) through (e) shall not be sold, traded, or given away during the permit period without notification and prior approval by the Department. The duration of the permit will be determined by the Department at the time of permit issue and shall not exceed the duration of an exhibitor's itinerary submitted to the Department at the time of permit application. The duration of the permit may be extended at the discretion of the Department. Note: Authority cited: Sections 208, 25990.5, 25992.3, 25992.5 and 25992.8, Health and Safety Code. Reference: Sections 25990.5, 25992.3, 25992.5 and 25992.8, Health and Safety Code. s 30075. Conditions of Quarantine for Personal Pets. Note: Authority cited: Sections 208, 25990.5 and 25992, Health and Safety Code. Reference: Sections 25990.5, 25992, 25992.3 and 25992.5, Health and Safety Code. s 30076. Permit Fees. (a) Each application for an import permit shall be accompanied by payment of an import permit fee to the Department. Except as provided in Section 30074.1(e), the permit fee charged shall be at the rate of $10.00 per animal. (b) If the actual number of animals received in the shipment exceeds the number enumerated in the application, payment of an additional fee, for the unpaid animal(s), shall be due at the rate of $10.00 per animal plus a charge of $10.00 for amending the original permit issued. (c) If the actual number of animals received is less than the number enumerated on the application, the person may apply for a refund subject to such verification and documentation as may be required by the department. (d) No refund shall be allowed for animals found dead on arrival (DOA), but credit may be allowed for animals DOA against future imports within the following 12 month period. No credit or refund shall be allowed for animals which die during quarantine or are found diseased and not fit for release from quarantine. (e) A previously issued import permit may be amended by the Department where necessary upon written request by the permittee provided the purpose of the amendment does not in the opinion of the Department jeopardize the intent and purpose of the required quarantine procedure or the public health. A fee of $10.00 must accompany the written request for amendment. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Section 25992.8, Health and Safety Code. s 30077. Animal Holding Facility. (a) Structural. The housing facilities used for quarantine of imported animals shall be constructed in accordance with the compiled State Building Code, Part 2, Chapter 2-93, Title 24, California Code of Regulations. All quarantine structures, fixtures, equipment and facilities shall be maintained so as to be clean, sanitary and in good repair. All quarantined animals shall be contained within the facility. (b) Storage. Supplies of food and bedding shall be adequately protected against contamination with zoonotic disease causing organisms. Refrigeration shall be provided for supplies of perishable food. (c) Medical Waste Disposal. Animal and food wastes, bedding, debris and any items present in the quarantine facility while a wild animal quarantine is in effect shall be disposed of as medical waste in accordance with Health and Safety Code, Section 25020, et seq. Disposal facilities shall be provided and operated as to prevent vermin infestation and minimize orders and diseases hazards. (d) Handwashing Facilities. Handwashing facilities, such as basins or sinks, shall be provided to maintain cleanliness among caretakers. Handwashing facilities shall include hot and cold running water, soap, paper towels, and a waste container. Handwashing facilities shall conform to the State Building Code, Part 5, Title 24, California Code of Regulations. (e) Drainage. A suitable method shall be provided to rapidly eliminate excessive water from housing facilities. If drains are used, they shall be properly constructed and shall be kept in good repair to avoid disease transmission within the facility. Draining facilities to rapidly eliminate excessive water from housing facilities shall conform to the State Building Code, Part 5, Basic Plumbing Regulations, Title 24, California Code of Regulations. (f) Local Building Codes, Zoning Codes, Use and Business Permits. Notwithstanding the provisions of these regulations, the provisions of local building codes, zoning codes, and applicable use and business permits shall be complied with by the owner or operator of quarantine facilities as a condition to approval by the Department, provided such provisions are at least equal to these regulations. Construction shall be in accordance with Title 24, California Code of Regulations. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994 and 25994.3, Health and Safety Code. s 30077.1. Alternative Housing Facilities. The use of alternative housing quarantine facilities for special purpose conditions may be approved by the Department upon written application provided the public health and safety shall not be endangered. These facilities shall be constructed in accordance with the State Building Code, Part 2, Chapter 2- 93, Title 24, California Code of Regulations. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994 and 25994.3, Health and Safety Code. s 30078. Primary Enclosures. Primary enclosures shall conform to the following requirements: (a) They shall be maintained so as to be clean and dry. (b) They shall provide convenient access to clean food and water. (c) Primary enclosures shall conform to the State Building Code, Part 2, Chapter 2-93, Title 24, California Code of Regulations. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994 and 25994.3, Health and Safety Code. s 30079. Animal Health and Husbandry Standards. (a) Food. (1) The food shall be free from contamination, wholesome, and of sufficient quality and nutritive value to meet the known normal daily requirements for the condition and size of the animal. (2) Food, and food receptacles if used, shall be accessible to all animals and shall be placed so as to minimize contamination by excreta. Food receptacles, except self feeders, shall be kept clean and sanitized at least once a week. (b) Watering. (1) All watering receptacles shall be kept clean and shall be sanitized at least once a week. (2) Automatic watering devices shall be maintained in accordance with good husbandry practices. They shall be sanitized when occupancy in the primary enclosure is changed and at the end of quarantine period. (c) Sanitation. (1) Cleaning of Primary Enclosures. Excreta shall be removed from the primary enclosures at least daily, or as often as necessary to prevent contamination of the animals contained therein and to reduce disease hazards and odors. When hosing or flushing methods are used for this purpose, measures shall be taken to prevent animals confined in such enclosures from being wetted or contaminated involuntarily. (2) Sanitization of Primary Enclosures. (A) Prior to the introduction of animals into primary enclosures previously occupied by other animals, such enclosures shall be sanitized in the manner provided in subparagraph (c)(3) of this subdivision.(B) Primary enclosures shall be sanitized often enough to prevent an accumulation of debris or excreta, or a disease hazard: Provided, however, that such enclosures shall be sanitized at least once every two weeks in the manner provided in subparagraph (c)(3) of this subdivision. (3) Sanitizing Procedures. Cages, rooms, vehicles and hard surfaced pens or runs shall be sanitized either by washing them with hot water (180 F.) and soap or detergent, as in a mechanical cage washer, or by washing all soiled surfaces with a detergent solution followed by a safe and effective disinfectant, or by cleaning all soiled surfaces with live steam. (d) Housekeeping. Premises (buildings and grounds) shall be kept clean and in good repair in order to protect the animals from injury and to facilitate the prescribed husbandry practices set forth in this section. Premises shall remain free of accumulations of trash. (e) Pest Control. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained. (f) Employees. A sufficient number of employees shall be utilized to maintain the prescribed level of husbandry practices set forth herein. Persons well trained and competent in retrieving, restraining and releasing animals in a humane manner for testing and examination procedures during quarantine must be provided. Such practices shall be carried out by or under the supervision of an animal caretaker who has a background in animal husbandry or care. Proper safeguards and precautions shall be practiced by employees so as not to endanger themselves, other persons, or animals. Outer work clothing, gloves, boots, etc., used in caring for animals in quarantine shall not be worn outside the quarantine area. (g) Classification and Separation. (1) Animals housed in the same primary enclosure shall be maintained in compatible groups and shall not be housed in the same primary enclosure with other animal species. (2) Animals entering quarantine on different dates shall not be housed in the same room, unless the quarantine periods commence with the date of the last animal(s) admitted to the room (See Section 30081). (h) Veterinary Care. (1) Programs of disease control and prevention, euthanasia, and adequate veterinary care shall be established and maintained under the supervision and assistance of a veterinarian. (2) Each animal shall be observed daily by the animal caretaker in charge or by someone working under his direct supervision. Sick or dis eased, injured, lame, or blind animals shall be provided with veterinary care or humanely disposed of unless such action is inconsistent with the purposes for which the animals are being imported. (i) Vehicles. (1) Vehicles used in transporting animals shall be mechanically sound and equipped to provide fresh air to all animals being transported, without injurious drafts. The vehicles shall contain the animals and restrict the entry of other animals and unauthorized persons. (2) The ability to view the interior of the cargo space is necessary to observe any animals that may have escaped from their primary enclosures. (3) The interior of the animal cargo space shall be kept clean. (4) The animal cargo space and all primary enclosures used in transport shall be cleaned and sanitized in the manner provided in subsection (c)(3) of this section after each shipment has been transported from the point of arrival to the quarantine facility. Animals entering quarantine and those having completed the quarantine shall not be transported concurrently in the same vehicle. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994 and 25994.3, Health and Safety Code. s 30080. Approved Quarantine Facilities. (a) Approval. Quarantine facilities used to house imported animals are subject to inspection and approval by representatives of the Department for such periods of time as the Department deems indicated. Such facilities may be used for housing imported animals only as long as they are maintained and operated in conformance with standards prescribed in Sections 30070 through 30086; in Title 42 of the Code of Federal Regulations, Section 71.53; and in "Biosafety in Microbiological and Biomedical Laboratories", U.S. Department of Health and Human Services, Public Health Service, Centers fro Disease Control and National Institutes of Health, 2nd edition, 1988; which are hereby incorporated by reference. (b) Inspection. The department may make such inspection of approved facilities as it deems necessary to insure compliance with prescribed standards. Such inspections shall be carried out by department representatives at any time, normally during but not restricted to working hours. (c) Notification of Change in Name or Ownership. The department shall be notified of any change in name, address, management or substantial control or ownership of any approved facility. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5 and 25992.5, Health and Safety Code. s 30081. Quarantine. All imported animals must be maintained for such period of quarantine as may be required by the Department and under such conditions as prescribed herein: (a) Quarantine Period and Conditions for Release Therefrom. (1) Primates. The normal quarantine period required for primates is that which provides for a physical examination, administration of a tuberculin test by a veterinarian upon entry and a repeat physical examination and tuberculin test 30 days later. Primates may be released from quarantine by the department upon completion of the second tuberculin test provided that in the judgment of the attending veterinarian: (A) Both tuberculin tests are negative. (B) The animals exhibit no visible oral ulcers at the end of quarantine period. (C) The animals show no clinical evidence of dysentery or diarrhea, emesis, emaciation, contagious skin lesions, central nervous system disturbances, jaundice, or abnormal respiratory signs at the end of quarantine period. (D) There is no evidence of a zoonotic disease traced back to the quarantined animals. (E) In the opinion of the attending veterinarian the animals are healthy. A summary report by the attending veterinarian, in writing over his signature, shall be made to the department incorporating 1) the results of all tests, physical examinations, etc., performed and 2) his opinion that the animals are healthy (See Section 30084). (2) Carnivores. Carnivores shall be confined in a place and manner approved by the Department for a 90 day period. A primary enclosure as defined under Section 2-9302 and set forth under Section 2-9305, Title 24, California Code of Regulations, or an equivalent approved by the Department, is acceptable for confinement. If at the end of quarantine, the animals are examined and found healthy by a veterinarian, they may be released by the Department upon receipt of such certification in writing by the attending veterinarian without further restriction. (b) Imported animals refused release from quarantine shall be handled in such manner as approved and specified by the department. (c) Where the quarantine procedures specified herein are not compatible with the objective of a specific research project, the department may authorize variations from the requirements specified herein provided that no public health hazard will result from the variations allowed. (d) Any person importing animals for purposes of sale to any educational and research institution, zoological garden, laboratory, college or university, may satisfy the requirements of this section and Sections 30081.1-30084 by contract with such institution. Such quarantine shall meet all of the requirements herein with regard to period, observation, reporting and other conditions of quarantine. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5 and 25994.3, Health and Safety Code. s 30081.1. Tuberculin Test. The method of tuberculin testing used shall be subject to approval by the department. Normal variations in site of administration and type and dilution of tuberculin used for intradermal injection may be accepted by the department. The use of such testing methods as the patch and multiple puncture tests will not be accepted. s 30082. Record Keeping. Adequate records shall be kept by permit number showing daily health status of each animal in the shipment, together with notation, under veterinary supervision, of signs of any illness, deaths, any treatment given, results of any tests or examinations performed, etc., on all animals in the shipment. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5 and 25994.3, Health and Safety Code. s 30083. Animal Identification. Identification of animals shall be maintained through use of cage numbers, tags on individual animals, or by means of tattoo. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5 and 25994.3, Health and Safety Code. s 30084. Reporting of Tests Results, Physical Examinations, Illnesses, Deaths. (a) A written summary report by the attending veterinarian of the results of all tests, physical examinations, etc., performed shall be made to the department in writing over a signature of the attending veterinarian. (b) Deaths or illnesses in quarantined animals shall be immediately reported to the attending veterinarian and then to the Department without delay. Dead animals shall be handled as biohazardous medical waste and kept under refrigeration pending necropsy instructions by the attending veterinarian. A necropsy shall be conducted under strict infection control precautions by the attending veterinarian or otherwise qualified pathologist, and adequate specimens shall be obtained for diagnostic laboratory examination to determine the cause of illness or death. Following necropsy, the carcass shall be handled and disposed of as biohazardous waste. (c) Records shall be maintained by the quarantine facility for a two-year period and shall be available for department examination upon request. Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reference: Sections 25990.5, 25994.3 and 25994.5, Health and Safety Code. s 30085. Cooperating Agencies. It is the intent of the department to maintain liaison and to cooperate fully with other governmental agencies having jurisdiction with regard to the import, holding, or regulation of animals into the United States and California as well as within the State. These agencies include: (a) Foreign Quarantine Program, Center for Disease Control, U.S. Department of Health, Education and Welfare. (b) Animal Resources Branch, Division of Research Facilities and Resources, National Institutes of Health, U.S. Department of Health, Education and Welfare. (c) Bureau of Sport Fisheries and Wildlife, Fish and Wildlife Service, U.S. Department of Interior. (d) Bureau of Customs, U.S. Treasury Department. (e) Animal Health Division, Agricultural Research Service, U.S. Department of Agriculture. (f) U.S. Department of Defense. (g) California Department of Fish and Game. (h) California Department of Agriculture. (i) County and city government, including local public health agencies, within the State of California. Any importation or other acquisition of wild animals under these regulations does not relieve the importer's responsibility for complying with any applicable health, quarantine, agriculture, customs, license, permit or any other requirements imposed by the laws or regulations of other duly authorized federal or State agency or county, city and county, or city government in California. s 30086. Exceptions. The department upon application may grant variances from the requirements of these regulations as it determines are authorized by law and will not result in hazard to the public health. Such applications, and variances made thereon, shall be in writing; any variances granted under this section shall set forth conditions designed to protect the public health, and shall be granted only for a specified period, not to exceed 6 months. s 30100. General Definitions. As used in subchapter 4: (a) "Act" means the "Radiation Control Law," Health and Safety Code, Division 104, Part 9, chapter 8, sections 114960 et seq. (b) "Agreement State" means any state with which the United States Atomic Energy Commission or Nuclear Regulatory Commission has entered into an effective agreement under section 274b of the Atomic Energy Act of 1954, Title 42, United States Code, section 2021(b) (formerly section 274(b)). (c) "Decommission" means to remove safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of the license. (d) "Department" means the State Department of Health Services. (e) "Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material. (f) "Hazardous radioactive material", as used in section 33000 of the California Vehicle Code and 114820(e) of the Health and Safety Code means any "highway route controlled quantity" of radioactive material as such material is defined in The United States Code of Federal Regulations (CFR), 49 CFR 173.403(l) as printed in FR 13431, March 31, 1983. (g) "Human use" means the internal or external administration of radiation or radioactive materials to human beings. (h) "Installation" means the location where one or more reportable sources of radiation are possessed. (i) "License," except where otherwise specified, means a license issued pursuant to group 2, Licensing of Radioactive Material. (j) "Misadministration" means the administration of: (1) A radiopharmaceutical or radiation from a sealed source other than the one intended; (2) A radiopharmaceutical or radiation to the wrong patient; (3) A radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing physician; (4) A diagnostic dosage of a radiopharmaceutical differing from the prescribed dosage by more than 50 percent; (5) A therapeutic dosage of a radiopharmaceutical differing from the prescribed dosage by more than 10 percent; or (6) A therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treatment geometry result in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10 percent. (k) "Other official agency specifically designated by the Department" means an agency with which the Department has entered into an agreement pursuant to section 114990 of the Health and Safety Code. (l) "Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other state or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, other than the United States Nuclear Regulatory Commission, the United States Department of Energy, or any successor thereto, and other than Federal Government agencies licensed by the United States Nuclear Regulatory Commission, under prime contract to the United States Department of Energy, or any successor thereto. (m) "Personnel monitoring equipment" means devices designed to be worn or carried by an individual for the purpose of measuring the dose received by that individual (e.g., film badges, pocket chambers, pocket dosimeters, film rings, etc.). (n) "Possess" means to receive, possess, use, transfer or dispose of radioactive material pursuant to this regulation. (o) "Possessing a reportable source of radiation" means having physical possession of, or otherwise having control of, a reportable source of radiation in the State of California. (p) "Radiation" (ionizing radiation) means gamma rays and X-rays; alpha and beta particles, high-speed electrons, neutrons, protons, and other nuclear particles; but not sound or radio waves, or visible, infrared, or ultraviolet light. (q) "Radiation machine" means any device capable of producing radiation when the associated control devices are operated, but excluding devices which produce radiation only by the use of radioactive material. (r) "Radioactive material" means any material which emits radiation spontaneously. (s) "Registrant" means any person who is registering or who has registered with the Department pursuant to group 1.5, Registration of Sources of Radiation. (t) "Reportable sources of radiation" means either of the following: (1) Radiation machines, when installed in such manner as to be capable of producing radiation. (2) Radioactive material contained in devices designed and manufactured for the purpose of detecting, measuring, gauging, controlling thickness, density, level, interface location, radiation, leakage or qualitative or quantitative chemical composition, for producing light or an ionized atmosphere, possessed pursuant to a general license under provisions of section 30192.1 of group 2 of this subchapter (Licensing of Radioactive Materials). (u) "Research and development" means theoretical analysis, exploration, experimentation or the extension of investigative findings and scientific or technical theories into practical application for experimental or demonstration purposes, including the experimental production and testing of models, prototype devices, materials and processes; but shall not include human use. (v) "Sealed source" means any radioactive material that is permanently encapsulated in such manner that the radioactive material will not be released under the most severe conditions likely to be encountered by the source. (w) "Source of radiation" means a discrete or separate quantity of radioactive material or a single radiation machine. (x) "Special nuclear material" means: (1) Plutonium, uranium 233, uranium enriched in the isotope 233 or in the isotope 235, and any other material which the Department declares by rule to be special nuclear material after the United States Nuclear Regulatory Commission, or any successor thereto, has determined the material to be such, but does not include source material; or (2) Any material artificially enriched by any of the foregoing, but does not include source material. (y) "Specific license" means a license or the equivalent document issued to a named person by the Department or by the Nuclear Regulatory Commission or by any other Agreement State. (z) "This regulation" means: California Code of Regulations, Title 17, Chapter 5, Subchapter 4. (aa) "User" means any person who is licensed to possess radioactive material or who has registered as possessing a reportable source of radiation pursuant to groups 1.5 and 2 of this subchapter, or who otherwise possesses a source of radiation which is subject to such licensure or registration. (ab) "Worker" means any individual engaged in activities subject to title 17, California Code of Regulations, chapter 5, subchapter 4, and controlled by a user, but does not include the user. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 114985 and 115060, Health and Safety Code. s 30102. Registration Requirement. s 30103. Communications. s 30104. Exemptions. (a) The Department may, upon application by any user, or upon its own initiative, grant such exemptions from the requirements of this regulation as it determines are authorized by law and will not result in undue hazard to health, life or property. Applications for exemptions shall specify why such exemption is necessary. (b) Before granting an exemption, the Department shall determine that there is reasonable and adequate assurance that: (1) the doses to any individual in any controlled area will not exceed those specified in Section 30265; (2) the dose to the whole body of any individual in an uncontrolled area will not exceed 0.5 rem in a year; (3) The deposition of radioactive material in the body of any individual will not likely result in a greater risk to the individual than would be expected from the dose specified in Section 30104 (b)(1) or (2), as appropriate, based on guidance from such bodies as the International Commission on Radiological Protection, and the National Council on Radiation Protection and Measurements; and (4) there is no significant hazard to life or property. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25815 and 25876, Health and Safety Code. s 30105. Deliberate Misconduct. (a) A user, applicant for a license or registration, employee of a user or applicant, or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any user or applicant for a license or registration, who knowingly provides to any user, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a user's or applicant's activities subject to this regulation, shall not: (1) Engage in deliberate misconduct, as defined in subsection (c), that causes or would have caused, if not detected, a user or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Department; or (2) Deliberately submit to the Department, a user, an applicant, or a user's or applicant's contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the Department. (b) A person who violates subsection (a) shall be subject to enforcement action in accordance with the Act. (c) For the purposes of subsection (a), deliberate misconduct by a person means an intentional act or omission that the person knows: (1) Would cause a user or applicant to be in violation of any rule, regulation, or order, or any term, condition, or limitation, or any license or registration issued by the Department; or (2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a user, applicant, contractor, or subcontractor. Note: Authority cited: Sections 100170, 100275, 115000, 115230 and 115235, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115215, 115230 and 115235, Health and Safety Code. s 30108. Registration Requirement. Every person possessing a reportable source of radiation shall register with the Department in accordance with the provisions of Sections 30110 through 30146. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Section 25815, Health and Safety Code. s 30110. Initial Registration. (a) Every person not already registered who acquires a reportable source of radiation shall register with and pay the fee as specified in Section 30145 to the Department within 30 days of the date of acquisition. (b) Every person who intends to acquire a radiation machine capable of operating at a potential in excess of 500 kVp shall notify the Department at least 60 days prior to his/her possession of the machine or at least 60 days prior to the commencement of construction or reconstruction of the room which will house the machine, whichever occurs first. This equipment shall not be used to treat patients until written approval of provisions for radiation safety has been obtained by the user from the Department. (c) Every person who registers or renews a registration shall complete a separate registration form furnished by the Department for each separate installation. Note: Authority cited: Sections 208 and 25811(c), Health and Safety Code. Reference: Section 25815(b), Health and Safety Code. s 30111. Renewal of Registration. Every person already registered pursuant to 30110 shall renew such registration annually and pay the fee as specified in Section 30145 to the Department on or before the registration renewal date. Note: Authority cited: Sections 100275 and 115000(c), Health and Safety Code. Reference: Section 115060(b), Health and Safety Code. s 30112. Registration Form. s 30113. Separate Installations. s 30115. Report of Change. The registrant shall report in writing to the Department, within 30 days, any change in: registrant's name, address, location of the installation or receipt, sale, transfer, disposal or discontinuance of use of any reportable source of radiation. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Section 25815, Health and Safety Code. s 30116. Report of Discontinuance. s 30117. Registration Shall Not Imply Approval. s 30118. Vendor Obligation. (a) Any manufacturer, distributor, retailer, agent, or any other person who sells, leases, transfers or lends a radiation machine to any person who may be required to register such machine shall notify the Department on a form approved by the Department no later than 30 days after the end of each calendar quarter of: (1) The names and addresses of persons who have received such machines. (2) The manufacturer and model of each such machine. (3) The date of transfer of each radiation machine. (4) Other related information as may be required by the Department. (b) The vendor shall inform the receiver of each machine of the registration requirements of Section 30108 of these regulations. Note: Authority cited: Sections 208 and 25811(c), Health and Safety Code. Reference: Section 25815(b), Health and Safety Code. s 30120. Reportable Sources of Radiation. s 30125. Excluded Material and Devices. The following devices and materials do not require registration: (a) Electrical equipment that produces radiation incidental to its operation for other purposes, but which does not produce radiation in any area accessible to individuals such that there is a reasonable likelihood that any individual will receive a radiation dose to the whole body, head and trunk, gonads, or lens of the eye or active blood-forming organs in excess of 0.5 rem in a year. (b) All radioactive materials except as specified in Section 30192.1. Note: Authority Cited: Sections 208 and 25811(c), Health and Safety Code. Reference: Section 25815(c), Health and Safety Code. s 30126. Exempt Possessors. Common and contract carriers are exempt from the requirement to register to the extent that they transport or store reportable sources of radiation in the regular course of their carriage for another or storage incident thereto. Note: Authority cited: Sections 208 and 25811(c), Health and Safety Code. Reference: Section 25815(b), Health and Safety Code. s 30130. Radiation Protection Standards. s 30131. Records to be Maintained. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30140. Violations. s 30145. Registration Fees. (a) Each radiation machine that is a reportable source of radiation as defined in section 30100(t), is classified as one of the following: (1) "High priority radiation machine," a radiation machine, which has high potential for exposing humans by means of heavy use, high radiation exposure, specialized use for radiosensitive areas of the human body, or misadjustment or malfunction of radiation safety features. A high priority radiation machine is further defined as one of the following machine types, or a machine that is used by any of the following categories of users: (A) Orthopedist. (B) Radiologist or roentgenogoloist. (C) Chiropractor. (D) Hospital. (E) Medical clinic. (F) Portable X-ray service (human use). (G) Fluoroscope used on humans. (H) Chest photofluorography (minifilm unit). (I) Non-human use particle accelerator with maximum energy capable of equaling or exceeding 10 MeV. (J) Non-human use radiation machine used in field radiography, as defined in Section 30336(c). (2) "Medium priority radiation machine," a radiation machine not covered by subsections (a)(1), (a)(3) or (a)(4). (3) "Dental priority radiation machine," a radiation machine used exclusively in dental radiography of human beings. (4) "Special priority radiation machine," a radiation machine used for mammography. (b) When a radiation machine is equipped with two or more tubes that can be used separately, each tube shall be considered as a single radiation machine. (c) Except as provided in (d), initial registration shall be valid for a period of one year. (d) The initial registration period for a reportable source of radiation being registered by a person who has a reportable source of radiation already registered with the Department shall be coterminous with the existing registration. (e) Any fees collected for a radiation machine for any registration period shall be transferred to any replacement radiation machine for the remainder of the registration period. (f) For initial registration or renewal of registration, the fees shall be $214.00 annually for each high priority radiation machine, $172.00 annually for each medium priority radiation machine, $79.00 annually for each dental priority radiation machine and, except as provided in section 30145.1, $475.00 annually for each special priority radiation machine. Where the initial registration period is less than one year pursuant to subsection (d), the initial registration fee shall be prorated, based on the priority classification and number of full months in the initial registration period in accordance with the following formula: Initial Registration Fee = A x [B/ (12 Months)] Where: A = Annual fee as specified above, dollars per year B = Number of full months remaining in coterminous period (g) The total registration fee paid by a registrant for high priority, medium priority, special priority, and dental priority radiation machines, which are at the same installation, shall not exceed $6,000.00 per year. (h) A late fee of 25% of the annual fee shall be charged for any registration fee which is 30 days past due. (i) Fees required by this section shall be nonrefundable. Note: Authority cited: Sections 100275, 115000, 115060, 115065, 115080 and 115085, Health and Safety Code. Reference: Sections 114980, 115080, 115085 and 115165, Health and Safety Code. s 30145.1. Registration Fee, Mammography Exception. The fee shall be $282.00 annually for each special priority radiation machine accredited by an independent accrediting agency recognized under the federal Mammography Quality Standards Act [42 U.S.C. 263(b)]. Note: Authority cited: Sections 100275, 115000(c), 115065, 115080 and 115085, Health and Safety Code. Reference: Sections 115080 and 115085, Health and Safety Code. s 30146. Payment of Fee. Each registration or registration renewal which reports possession of a radiation machine, and each report of change reporting the receipt of an additional radiation machine, shall be accompanied by an amount to pay the fee for the period to the next regularly scheduled registration renewal date. Note: Authority cited: Sections 208 and 25811(c), Health and Safety Code. Reference: Section 25817, Health and Safety Code. s 30170. Authority. Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 25780 and 25800 through 25870, Health and Safety Code. s 30172. License Requirement. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30173. Communications. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30175. General Definitions. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30180. Exempt Persons, Products, Concentrations and Quantities. (a) Any person is exempt from this regulation if such person: (1) Is a common and contract carrier transporting radioactive material in the regular course of their carriage for another or storage incident thereto. Such carriers are subject to the provisions of Group 4, Transportation of Radioactive Material. (2) Is licensed by the United States Nuclear Regulatory Commission under Title 10, Code of Federal Regulations, Part 150, Section 150.15, Continued Commission Regulatory Authority in Agreement States, or otherwise agreed upon by the Department and the Commission. (3) Is under a prime contract with the United States Nuclear Regulatory Commission or the United States Department of Energy at a U.S. Government-owned or controlled site, including the transporting of radioactive material to or from such site, the performance of contract services during temporary interruptions of such transportation; for research in or development, manufacture, storage, testing or transportation of atomic weapons or components thereof; or for the use of nuclear devices in U.S. Government-owned vehicle or vessel; or under a subcontract when it is jointly determined by the Department and the United States Nuclear Regulatory Commission that an exemption is appropriate. (b) The following products are exempt from this regulation: (1) Timepieces, hands or dials therefor, containing any radioactive luminous material provided these have been distributed as exempt products in accordance with a United States Nuclear Regulatory Commission license: and any timepieces, hands or dials therefore containing radium activated luminous material. (2) Automobile lock illuminators containing up to 15 millicuries of tritium or 2 millicuries of promethium 147 per lock. (3) Compounds or mixtures with rare earth elements containing up to 0.25% by weight of source material. (4) Glazed ceramic tableware containing up to 20% by weight of source material in the glaze. (5) Glassware containing not more than 10 percent by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction; (6) Glass enamel or glass enamel frit containing not more than 10 percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983. (7) Photographic film, negatives, and prints containing source material. (8) Incandescent gas mantles, vacuum tubes, electric lamps, and welding rods containing thorium. (9) Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys; provided that the thorium content of the alloy does not exceed 4% by weight. (10) Finished optical lenses containing up to 30% by weight of thorium, but not including spectacles, contact lenses, or eyepieces of optical instruments and subject to not altering the finished product by any process such as shaping, grinding, or polishing. (11) Fire detector heads containing up to 0.005 microcuries of uranium per head. (12) Electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium. (13) Germicidal lamps, sun lamps and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two grams of thorium. (14) Personnel neutron dosimeters provided that each dosimeter does not contain more than 50 milligrams of thorium. (15) Shipping containers utilizing natural or depleted uranium metal as shielding, if such container is and remains: (A) Conspicuously impressed with the legend: "CAUTION -RADIOACTIVE SHIELDING - URANIUM" and; (B) The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one eight inch (3.2 mm). (16) Counterweights of uranium installed in, or store or handled in connection with installation in or removal from, aircraft, rockets, projectiles, or missiles, if each such counterweight has been manufactured pursuant to an appropriate specific license; and (A) each counterweight manufactured prior to December 31, 1969 has been, and remains, impressed, labeled and marked in accordance with the provisions of that specific license at the time of manufacture; (B) each counterweight manufactured on or after December 31, 1969 has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM"; and is durably and legibly labeled or marked with the identification of the manufacturer, and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED." (17) Precision balances or parts therefor, provided that no such balance contains more than 1.0 millicurie of tritium and no balance part contains more than 0.5 millicurie of tritium. (18) Automobile shift quadrants containing not more than 25 millicuries of tritium. (19) Marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas. (20) Thermostat dials and pointers containing not more than 25 millicuries of tritium per thermostat. (21) Thorium contained in any finished aircraft engine part containing nickel-thoria mixture, provided that: (A) The thorium is dispersed in the nickel-thorium mixture in the form of finely divided thorium dioxide; and (B) The thorium content of the mixture does not exceed 4% by weight. (22) Electron tubes: Provided that each tube does not contain more than one of the following specified quantities of radioactive material: (A) 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube; (B) 1 microcurie of cobalt 60; (C) 5 microcuries of nickel 63; (D) 30 microcuries of krypton 85; (E) 5 microcuries of cesium 137; (F) 30 microcuries of promethium 147; and provided further, that these have been manufactured and distributed pursuant to an appropriate specific license. Note:Electron tubes include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes and any other completely sealed tube that is designed to conduct or control electrical currents.) (23) Synthetic plastic resins containing scandium 46 and designed for sand consolidation in oil wells provided such resins shall have been manufactured or imported in accordance with a specific license which authorizes their distribution as exempt products. (24) Intact meters containing radium activated luminous material. (25) Piezoelectric ceramic containing not more than 2 percent by weight source material. (26) Gas and aerosol detectors containing radioactive material and designed to protect life or property from fires and airborne hazards provided such detectors have been manufactured or imported in accordance with a specific license which authorizes their distribution as exempt products. (27) Self-luminous products containing tritium, krypton 85, or promethium 147 provided such products have been manufactured or imported in accordance with a specific license which authorizes their distribution as exempt products, and provided further that such products are not used primarily for frivolous purposes or as toys or adornments. (28) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that: (A) Each source contains no more than one exempt quantity set forth in section 30235, Schedule A, and (B) Each instrument contains no more than ten exempt quantities. For purposes of subsection (b)(28)(A) and (B), an instrument's source(s) may contain either one type or different types of radionuclides, and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in section 30235, Schedule A, provided that the sum of such fractions shall not exceed unity. (C) For purposes of subsection (b)(28)(B), 0.05 microcurie of americium- 241 is considered an exempt quantity under section 30235, Schedule A. (29) Spark gap irradiators containing not more than one microcurie of cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least three gallons per hour (11.4 liters per hour). (30) Capsules containing one microcurie of carbon-14 urea each, for in vivo diagnostic use for humans. Persons who use the capsules for research involving human subjects shall possess a specific license issued pursuant to section 30195. (c) The following concentrations and quantities are exempt from this regulation: (1) Any naturally-occurring radioactive material, except source material, in concentrations which occur naturally. Unprocessed ore in its natural form containing source material is exempt. Refining and processing are not exempt. (2) Any chemical mixture, compound, solution or alloy containing up to one-twentieth of one percent (0.05 percent) by weight of source material. (3) Any radioactive material in concentration not exceeding those specified in section 30237, Schedule C, except that a specific license shall be required by any person to transfer possession or control of any product or material into which radioactive material has been introduced in such concentrations except for transfers to appropriately licensed persons for analytical test or waste disposal purposes. (4) Radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in section 30235, Schedule A, if not more than 10 such scheduled quantities are possessed at any one time. (d) The exemptions contained in subsection (b) shall not authorize any of the following: (1) The manufacture of any product listed. (2) The application or removal of radioactive luminous material to or from meters and timepieces, or hands and dials therefor. (3) The installation into automobile locks of illuminators containing tritium or promethium 147 or the application of tritium to balances of precision or parts therefor. (4) The chemical, physical, or metallurgical treatment or processing of thorium-metal alloys. (5) Human use, or the use in any device or article, except time pieces and the product specified in subsection (b)(30), which is intended to be placed on or in the human body. (6) The chemical, physical, or metallurgical treatment or processing of uranium counterweights other than repair or restoration of any plating or other covering. (e) The exemptions specified in subsections (b)(30), (c)(3) or (c)(4) shall not authorize the production, packaging, repackaging or transfer of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115165 and 115235, Health and Safety Code. s 30181. Persons Exempt. s 30182. Other Exemptions. s 30190. Types of Licenses. (a) Department licenses for radioactive material are of two types: general and specific. (b) General licenses provided in this regulation are effective without the filing of an application with the department or the issuance of licensing documents to particular persons. (c) Specific licenses are issued to named persons upon approval of an application filed pursuant to this regulation. A specific license issued by the department is required by any person to possess any radioactive material in this state, except as otherwise provided in Sections 30180, 30181, 30182, 30191, 30192, or 30225. (d) Every specific and general license is subject to all applicable provisions of this regulation and, except as otherwise specified, to the provisions of Group 3 of this subchapter (Standards for Protection Against Radiation). s 30191. General Licenses-Source Material. (a) A general license is hereby issued to commercial firms, education, and medical institutions and government agencies, authorizing the possession and use of not more than 15 pounds of source material at any one time, for research, development, educational, commercial or operational purposes. Persons authorized to possess and use source material, pursuant to this general license, may not receive more than a total of 150 pounds of source material in any one calendar year. Any person shall, with respect to such source material, be exempt from the provisions of Group 3 of this subchapter, except for Sections 30253, 30254 and 30293(a), unless such person also possesses source material under a specific license. (b) A general license described in Section 30191(a) shall not authorize human use; or the use in any device or article which is intended to be placed on or in the human body; or the use of any instrument or apparatus (including component parts and accessories thereto) intended for human use. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115000, 115060, 115165 and 115235, Health and Safety Code. s 30192. General Licenses -Static Elimination or Ion Generation Devices. (a) A general license is hereby issued to any person authorizing possession of radioactive material incorporated in any of the following items when manufactured pursuant to a specific license which authorizes distribution to general licensees: (1) Static eliminators containing sealed sources of up to 500 microcuries of polonium 210 per device. (2) Air ionization devices containing, as sealed sources, up to 500 microcuries of polonium 210 or 50 millicuries of hydrogen 3 per device. (b) Possession of radioactive material listed in this section is exempt from the requirements of Group 3 of this subchapter except for Sections 30253, 30254, and 30293(a). Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115060, 115165 and 115235, Health and Safety Code. s 30192.1. General Licenses -Gauging and Controlling. (a) A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and government agencies to possess and use radioactive material when contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, qualitative or quantitative chemical composition or for producing light or an ionized atmosphere when such devices are manufactured pursuant to a specific license authorizing distribution to general licensees provided that each such device: (1) Is labeled in accordance with the provisions of the specific license which authorizes distribution of the device; (2) Bears a label containing the following or substantially similar statement: "The receipt, possession, use and transfer of this device, Model ____, Serial No. ____, are subject to a general license or equivalent and the regulations of the United States Nuclear Regulatory Commission or of a state with which the United States Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Removal of this label is prohibited. CAUTION -RADIOACTIVE MATERIAL ______________________________ (Name of Supplier)" The model, serial number and name of supplier may be omitted from this label provided they are elsewhere specified in labeling affixed to the device; and (3) Is installed on the premises of the general licensee by a person having a specific license which authorized installation of such devices when required by the label on the device. (b) Persons who possess a device pursuant to the general license contained in Section 30192.1(a) shall: (1) Within 30 days of the receipt of any such device, register with the Department and within 30 days of transfer of any such device, notify the Department in accordance with the provisions of Group 1.5 of this subchapter (Registration of Radiation Sources). (2) Not transfer, abandon or dispose of the device, except by transfer to a person holding a specific license to receive such device. (3) Transfer the device to another general licensee only; (A) Where the device remains in use at a particular location. In such case the transferrer shall give the transferee a copy of this section and any safety documents identified in the label of the device, or; (B) Where the device is held in storage in the original shipping container at its intended location of use prior to initial use by the general licensee. (4) Assure that all labels affixed to the device at the time of receipt and bearing the statement, "Removal of this label is prohibited" are maintained thereon and comply with all instructions contained in such labels. (5) Have the device tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at the time of installation of the device or replacement of radioactive material on the premises of the general licensee and thereafter at no longer than six-month intervals or at such longer intervals as may be specified in the specific license which authorized distribution of the device to general licenses. Devices containing only krypton need not be tested for leakage. Devices containing only tritium or not more than 100 uCi of other beta and/or gama emitting material or 10 uCi of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any reason. (6) Have the test required by Section 30192.1(b)(5) and all other services involving the radioactive material, its shielding and containment performed: (A) In accordance with the instructions provided by the label; or (B) By a person holding an appropriate license therefor. (7) Maintain records of all tests performed on the devices as required under this section, including the dates and results of these tests and the names and addresses of the persons conducting the test. (8) Upon occurrence of a failure of or damage to, or any indication of a possible failure of or damage to the shielding or containment of the radioactive material, or of the on-off mechanism or indicator, immediately suspend operation of the device until it has been repaired by or disposed of to a person holding a specific license therefor. (9) Within 30 days after the occurrence of a failure of or damage to the shielding or containment of radioactive material or the on-off mechanism or indicator or upon the detection of 0.005 microcuries or more of removable radioactive material, furnish to the Department a complete description of the device (manufacturer, type, serial number) and a brief description of the event and the remedial action taken. (c) Persons who possess a device pursuant to the general license contained in Section 30192.1(a) shall with respect thereto be exempt from the requirements of Group 3 of this subchapter except for Sections 30253, 30254, and 30293(a). Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115060, 115165, 115230 and 115235, Health and Safety Code. s 30192.2. General Licenses -Aircraft Safety Devices. (a) A general license is hereby issued to any person to possess and use tritium or promethium 147 contained in luminous safety devices designed for use in aircraft provided that each such device contains not more than 10 curies of tritium or 300 millicuries of promethium 147 and has been manufactured, assembled or imported in accordance with a specific license authorizing distribution to general licensees. (b) The general license contained in Section 30192.2(a) does not authorize: (1) The manufacture, assembly, disassembly, repair or disposal of such devices. (2) The use of such devices other than in aircraft. (3) The possession of promethium 147 in instrument dials. (c) Persons who possess a device pursuant to the general license contained in Section 30192.2(a) shall, with respect thereto, be exempt from the requirements of Group 3 of this subchapter except for Sections 30253, 30254, and 30293(a). Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115060, 115165, and 115235, Health and Safety Code. s 30192.3. General Licenses -Calibration or Reference Sources. (a) A general license is hereby issued to persons who hold either a specific license issued by the Department for any radioactive material or a specific license issued by the United States Nuclear Regulatory Commission for any special nuclear material, to possess americium-241 or plutonium in the form of calibration or reference sources. Calibration or reference sources shall be manufactured in accordance with the specifications contained in an appropriate specific license which authorizes distribution under a general license. Each source possessed pursuant to the general license or its storage container shall bear a label which includes the information required in the following statement: "The receipt, possession, use and transfer of this source, Model ____, Serial No. ____, are subject to a general license or equivalent and the regulations of the United States Nuclear Regulatory Commission or of a state with which the United States Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Removal of this label is prohibited. CAUTION -RADIOACTIVE MATERIAL -THIS SOURCE CONTAINS (AMERICIUM 241 OR PLUTONIUM, whichever is appropriate). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE. _______________________________________" (Name of Manufacturer or Importer) (b) Persons who possess a source pursuant to the general license contained in Section 30192.3(a) shall: (1) Not have, at any one time, at any one location of storage or use, more than 5 microcuries of americium-241 and 5 microcuries of plutonium contained in such sources. (2) Not transfer, abandon or dispose of such sources except by transfer to a person authorized by a license to receive the source. (3) With respect to each such source when not in use, store the source in a closed container adequately designed and constructed to contain any of the radioactive material in case the source is ruptured or leaks. (4) Not use such source for any purpose other than calibration of radiation detectors or standardization of other sources. (c) Persons who possess a source pursuant to the general license contained in Section 30192.3(a) shall with respect thereto be exempt from the requirement of Group 3 of this subchapter except for Sections 30253, 30254, and 30293(a). (d) The general license in paragraph (a) of this section does not authorize the manufacture, import, or export of calibration or reference sources containing americium or plutonium. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115230 and 115235, Health and Safety Code. s 30192.4. General Licenses -Ice Detection Devices. (a) A general license is hereby issued to any person to possess strontium 90 contained in ice detection devices provided that each device contains not more than 50 microcuries of strontium 90 and each device has been manufactured or imported in accordance with a specific license which authorizes distribution under a general license. (b) Persons who possess a device pursuant to the general license contained in Section 30192.4(a) shall: (1) Assure that all labels affixed to the device at the time of receipt and which bear a statement that prohibits removal of the labels are maintained thereon; (2) Upon occurrence of damage, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license authorizing such testing or repair. (c) Persons who possess a device pursuant to the general license contained in Section 30192.4(a) shall, with respect thereto, be exempt from the requirements of Group 3 of this subchapter except for Sections 30253, 30254 and 30293(a). (d) This general license does not authorize the manufacture, assembly, disassembly or repair of ice detection devices containing strontium 90. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115060, 115165, 115230 and 115235, Health and Safety Code. s 30192.5. General Licenses -In Vitro Testing. (a) A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to possess and use radioactive material in prepackaged units described in Section 30236, Schedule B, Table I, for in vitro clinical testing. (b) The general licensee shall not possess or use radioactive material pursuant to the general license contained in this section: (1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued by the United States Nuclear Regulatory Commission or a state with which the United States Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority, and (2) Unless the prepackaged unit bears a label or is accompanied by a package insert containing the following or a substantially similar statement: "This radioactive material may be received and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material or the radiation therefrom to human beings or animals. The receipt, possession, use and transfer of this material is subject to regulations and general license of the United States Nuclear Regulatory Commission or the state with which the Commission has entered into an agreement for the exercise of regulatory authority." (c) Persons who possess radioactive material pursuant to the general license contained in Section 30192.5(a), shall with respect thereto be exempt from the requirements of Group 3 of this subchapter except for Sections 30253, 30254, and 30293(a). Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115000, 115060, 115165, 115230 and 115235, Health and Safety Code. s 30192.6. General Licenses -Depleted Uranium. (a) A general license is hereby issued to any person to possess and use depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass of the product or device when such products or devices are manufactured pursuant to a specific license authorizing distribution to general licensees. (b) Persons who possess depleted uranium pursuant to the general license contained in Section 30192.6(a) shall: (1) Within 30 days of receipt of any such product or device, register with the Department and within 30 days of transfer of any such device, notify the Department in accordance with provisions of Group 1.5 of this subchapter; (2) Not introduce such depleted uranium into any chemical, physical or metallurgical treatment or process except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium; (3) Maintain procedures designed to establish physical control over such depleted uranium to prevent unauthorized use or transfer; (4) Not transfer, abandon or dispose of such depleted uranium except by transfer to a person holding a specific or general license to receive such material. (c) Persons who possess depleted uranium pursuant to the general license contained in this section shall with respect thereto be exempt from the requirements of Group 3 of this subchapter except for Section 30253, 30254, and 30293(a). Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 114985(g), 115060, 115165, 115230 and 115235, Health and Safety Code. s 30193. Application for Specific Licenses and Amendments. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30194. Approval of Applications and Specific Terms and Conditions for Licenses. (a) An application for a new specific license or for renewal or amendment of an existing license will be approved if the Department determines that: (1) the applicant or his specified personnel are qualified by reason of training and experience to use radioactive material of the kinds and quantities and for the purposes requested, in such a manner as to provide reasonable and adequate assurance of protection to health, life, and property; (2) the applicant's equipment, facilities, proposed uses and procedures are such as to provide reasonable and adequate assurance of protection to health, life, and property; (3) the issuance of the license will not jeopardize the health and safety of the public; (4) the applicant satisfies all applicable requirements of the Act and regulations thereunder. (b) Prior to issuing, amending or renewing a license pursuant to the provisions of this subchapter, the Department may inspect at any reasonable time the place of business, or premises and facilities of any applicant in order to verify information contained in the application or to obtain additional information for the purpose of completing the application. (c) No license or any right under a license shall be assigned or otherwise transferred unless approved in advance by the Department. (d) Each licensee shall restrict possession of licensed material to the locations and conditions of the use authorized in the license. (e) Each specific license shall expire on the expiration date specified as a condition of the license. However, the license shall continue to be valid if a timely application for renewal is filed. An application for renewal shall be timely if filed at least 30 days prior to the expiration date. The existing license shall not expire until the department has taken final action on the timely filed application for renewal. (f) Applications and documents submitted shall be made available for public inspection except where the applicant identifies portions of the application as "trade secret" and the Department finds that the information is "trade secret" pursuant to provisions of the Public Records Act and Evidence Code Section 1060. (g) As provided by Section 30195.1, certain applications for specific licenses filed under Group 2 shall contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning. In the case of renewal applications submitted before January 1, 1996, the submittal of a proposed decommissioning funding plan or a certification of financial assurance for decommissioning may follow the renewal application but shall be submitted on or before January 1, 1996. Note: Authority cited: Sections 100110, 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115165, 115230 and 115235, Health and Safety Code. s 30194.1. Criteria for Authorizing Multiple Locations of Use. Criteria for authorizing more than one location of use on a specific license shall be as follows: (a) All locations shall be under the same business entity. (b) The radiation protection program required by section 20.1101 of Title 10, Code of Federal Regulations, Part 20 as incorporated by reference in section 30253 shall demonstrate that use of radioactive materials at each location shall be in accordance with this regulation. (c) A single location where licensing and compliance records will be maintained for Department review shall be designated. (d) The nature of radioactive materials use and the operations shall be the same at all locations. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060 and 115165, Health and Safety Code. s 30194.2. Amendment Requests. To amend an existing license, a licensee shall submit a written request to the Department containing: (a) The licensee's name and license number as shown on the specific license. (b) The nature and scope of the request. (c) The reasons for the request and supporting justifications including any documents relied upon. (d) If the request proposes to increase the maximum possession limit specified on the license, the request shall include the fee specified in section 30231(c). Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060 and 115165, Health and Safety Code. s 30195. Special Requirements for Issuance of Specific Licenses. In addition to the requirements set forth in Section 30194, specific licenses for certain specialized uses will be issued only if the following conditions are met: (a) For human use of radioactive material in institutions: (1) The institution has a formally-constituted and officially-recognized medical radiation safety committee, which should include a representative of the institution's administration and at least three individuals who are knowledgeable in the areas of human use of radioactive material and of radiation safety, and which shall evaluate all proposals for, and maintain surveillance over, all uses of radioactive material within the institution. (2) The institution has a radiation safety officer, who is a member of the radiation safety committee, and who is qualified by reason of training and experience to oversee the radiation safety aspects of radioactive material use in the institution. (3) The institution's application includes a detailed statement of qualifications, duties, authority, and responsibility of the radiation safety committee and the radiation safety officer. (4) The institution had adequate facilities for the clinical care of patients. (5) Each person to be designated as an individual radioactive material user is a physician and furnishes clear evidence of substantial training and experience in the kinds of uses proposed, including handling and administration of the radioactive material and the appropriate clinical management of patients. (b) For human use of radioactive material by individuals: (1) The applicant is a physician and furnishes clear evidence of having substantial training and experience in the kinds of uses proposed, including the handling and administration of the radioactive material and the appropriate clinical management of patients. (2) The applicant demonstrates access to adequate hospital facilities for the patients, where appropriate. (c) For use of multiple quantities of types of radioactive material for research and development or for processing for distribution: (1) The applicant has a radiation safety committee of at least three members which must evaluate all proposals for, and maintain surveillance over, all uses of radioactive material. Committee members shall be knowledgeable and experienced in pertinent kinds of radioactive material use and in radiation safety. (2) The applicant has a radiation safety officer, who is a member of the radiation safety committee, and who is supported by a staff of a size and degree of competence appropriate to deal with radiation safety problems that might be encountered. (3) The applicant furnishes a detailed statement of the qualifications, duties, authority, and responsibilities of the radiation safety committee and of the staff radiation safety group. (d) For distribution of devices to persons generally licensed under Sections 30192.1 and 30192.6: (1) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling, proposed uses and conditions of use, and potential radiation hazards of each device to provide reasonable assurance that: (A) the radioactive material contained in the device will not be lost; (B) no individual will receive a radiation dose to the whole body or major portion thereof, head and trunk, lens of the eye, gonads, or active blood-forming organs in excess of 0.5 rem in a year, under ordinary circumstances of use; (C) the device can be safely operated by individuals not trained in radiation safety; and (D) the radioactive material within the device would not be accessible to unauthorized individuals. (2) The applicant submits a sample of the labels to be affixed to the device which include instructions and precautions for safe operation, and indicates the manner in which the labels will be affixed and their location on the device. Each such label shall bear the statement, "Removal of this label is prohibited." Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25855 and 25876, Health and Safety Code. s 30195.1. Special Requirements for Issuance of Specific Licenses -Financial Surety for Decommissioning. (a) The regulations governing financial assurance for decommissioning in Title 10, Code of Federal Regulations, Section 30.35, as revised January 1, 1996, including Appendix A, B and C to Part 30 of Title 10, Code of Federal Regulations, referenced in such Section 30.35, are hereby incorporated by reference with the following exceptions: (1) Subsection 30.35(g) is not incorporated by reference. (2) The phrase "byproduct material" shall include all "radioactive material" as defined in Title 17, California Code of Regulations, Section 30100, except source material which shall be governed by subsection (b). (3) The date "January 1, 1996" is substituted for the date "July 27, 1990." (4) Any reference to the United States Nuclear Regulatory Commission or any component thereof shall be deemed to be a reference to the Department. (5) Any reference to Title 10, Code of Federal Regulations section 30.37 shall be deemed to be a reference to Section 30194. (6) The date "January 1, 1998" is substituted for the date "November 24, 1995." (b) The regulations governing financial assurance for decommissioning in Title 10, Code of Federal Regulations, Section 40.36, as revised January 1, 1996, including Appendix A to Part 40 of Title 10, Code of Federal Regulations, referenced in such Section 40.36, is hereby incorporated by reference with the following exceptions: (1) Subsection 40.36(f) is not incorporated by reference. (2) The date "January 1, 1996" is substituted for the date "July 27, 1990." (3) Any reference to the United States Nuclear Regulatory Commission or any component thereof shall be deemed to be a reference to the Department. (4) Any reference to Title 10, Code of Federal Regulations Section 40.43 shall be deemed to be a reference to Section 30194. (5) The date "January 1, 1998" is substituted for the date "November 24, 1995." (c) The following persons shall be exempt from the requirements of this section: (1) Persons authorized to possess no more than 1,000 times the quantity specified for each licensed material specified in Appendix B to Part 30 of Title 10, Code of Federal Regulations; (2) Persons authorized to possess hydrogen-3 contained in hydrogen gas in a sealed source; (3) Persons authorized to possess radioactive noble gases in sealed sources with no radioactive daughter product with half-life greater than 30 days; or (4) Persons authorized to possess no more than 10 mCi of source material in any form and source material in any quantity in a non-dispersible form. Note: Authority cited: Sections 100275, 115000, and 115091, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115091, 115092 and 115235, Health and Safety Code. s 30195.2. Special Requirements for Issuance of Specific Licenses -Emergency Plans. (a) The regulations governing application for specific licenses in Title 10, Code of Federal Regulations, Section 30.32, Subsection (i), as revised January 1, 1994, including section 30.72 of Title 10, Code of Federal Regulations, referenced in such Subsection (i), are hereby adopted by reference with the following exceptions: (1) The phrase "radioactive material" as defined in Title 17, California Code of Regulations, Section 30100 is substituted for the phrase "byproduct material." (2) Any reference to the Nuclear Regulatory Commission or any component thereof shall be deemed to be a reference to the Department. (b) In addition to the requirements set forth in ss 30194, 30195, 30195.1 and 30195.3, specific licenses shall be issued only if the requirements specified in Subsection (a) are met. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230, and 115235, Health and Safety Code. s 30195.3. Special Requirements for Issuance of Specific Licenses for Use of Sealed Sources in Nonmedical Radiography. (a) For licenses authorizing designation of radiographers by the licensee, an application for a specific license for the use of sealed sources in nonmedical radiography shall meet the requirements set forth in Section 30194 and shall demonstrate or describe: (1) An adequate program for training radiographers and radiographers' assistants, specifying in detail: (A) The nature and scope of initial training, on-the-job training, and refresher training; (B) Means of determining each individual radiographer's or radiographer's assistant's knowledge and understanding of and ability to comply with Department regulations and the applicant's license requirements, and the operating and emergency procedures. (2) Satisfactory operating and emergency procedures. (3) Its organizational structure pertinent to the radiography programs, including specified delegations of authority and responsibility. (4) An adequate system of internal controls to assure that radiographers and radiographers' assistants will comply with Department regulations and license conditions and the applicant's operating and emergency procedures. (b) For licenses in which the Department specifies radiographers by name, an application for a specific license for use of sealed sources in nonmedical radiography shall meet the requirements set forth in Section 30194 and demonstrate or describe: (1) The names of individuals who are to be specified in the license as radiographers, and describes the qualifications, including details of training and experience, of each such individual to act as a radiographer under the license. (2) An adequate training program for this type of license, specifying in detail: (A) The nature and scope of on-the-job training and refresher training of radiographers; (B) The nature and scope of initial training, on-the-job training, and refresher training of radiographers' assistants; (C) Means of determining each individual radiographer's or radiographer's assistant's knowledge and understanding of and ability to comply with Department regulations and the applicant's license requirements, and the operating and emergency procedures of the applicant; and (3) Satisfactory operating and emergency procedures. (4) Its organizational structure pertinent to the radiography programs, including specified delegations of authority and responsibility. (c) In addition to the requirements specified in either subsection (a) or (b) of this section, any application for a specific license for use of sealed sources in nonmedical radiography shall meet the requirements of Section 30194, and shall describe an adequate internal inspection system to assure that radiographers and radiographer's assistants will comply with Department regulations and license conditions and the applicant's operating and emergency procedures. The inspection program shall: (1) Include observation of the performance of each radiographer and radiographer's assistant during an actual radiographic operation at intervals not to exceed three months; (2) Provide that, if a radiographer or a radiographer's assistant has not participated in a radiographic operation for more than three months since the last inspection, that individual's performance shall be observed and recorded the next time the individual participates in a radiographic operation; and (3) Include the retention of inspection records on the performance of radiographers or radiographers' assistants for three years. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115165 and 115235, Health and Safety Code. s 30196. Issuance of Specific Licenses. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30197. Specific Terms and Conditions of Licenses. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30198. Expiration of Licenses. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30205. Modification, Suspension, Revocation and Termination of Licenses. (a) All licenses shall be subject to modification, suspension, or revocation by regulations or orders issued by the department. (b) Any license may be modified, suspended, or revoked by the department: (1) for any material false statement in the application or in any required report; (2) because of conditions revealed by any means which would warrant refusal to grant such a license on an original application; or (3) for violation of any terms and conditions of the Act, of the license, or of any relevant regulation or order of the department, including non-payment of license fee pursuant to Sections 30230-30232 of this regulation. (c) Prior to the institution of proceedings to modify, suspend, or revoke a license, facts or conduct which may warrant such action shall be called to the attention of the licensee in writing and the licensee shall be accorded reasonable opportunity to demonstrate or achieve compliance, except in cases of willful violation or those in which the public health or safety requires otherwise. (d) A specific license may be terminated by mutual consent between the licensee and the department. Note: Authority cited: Sections 208 and 25811(d), Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30210. Authorization for Transfer. (a) A licensee may transfer radioactive material only to persons listed below and only following acceptance of such transfer: (1) the Department; (2) any person who is exempt from this regulation to the extent permitted under such exemption; or (3) any person licensed or authorized to receive the material by the United States Nuclear Regulatory Commission, the Department, or any other Agreement State. (b) This section does not authorize the commercial distribution of radioactive material other than those items listed in Section 30192 through 30192.6, except when such distribution is authorized by a specific license. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30210.1. Verification Required. (a) Before transferring radioactive material to a licensee, the licensee transferring the material shall verify license authorization for the receipt of the type, form and quantity of radioactive material to be transferred. (b) The transferrer shall utilize methods of verification and maintain records of verification required by subsection (a) as specified in 10CFR30.41 (38FR33968). Note: (1) Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25855, 25875 and 25876, Health and Safety Code. (2) Copies of Title 10, Code of Federal Regulations -Energy, are for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. s 30210.2. Labeling Requirements for the Manufacture, Preparation or Transfer for Commercial Distribution of Drugs Containing Radioactive Material for Human Use as Authorized by a Specific License. (a) A person applying for a specific license to manufacture, prepare or transfer for commercial distribution radioactive drugs for human use shall satisfy the following labeling requirements: (1) A label shall be affixed to each transport radiation shield of a radioactive drug to be transferred for commercial distribution. The label shall include: (A) The radiation symbol and the words, "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; (B) The name of the radioactive drug or its abbreviation; and (C) The quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than 100 days, the time may be omitted. (2) A label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label shall include: (A) The radiation symbol and the words, "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL", and (B) An identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115165 and 115235, Health and Safety Code. s 30220. Violations. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30225. Persons Licensed by Other Agencies. (a) Any person who holds a specific license issued by the United States Nuclear Regulatory Commission, or by any other Agreement State or by any state that has been either provisionally or finally designated as a Licensing State by the Conference of Radiation Control Program Directors, Inc., other than this State, may conduct activities of the kind therein authorized within this State for a period not in excess of 180 days in any calendar year without obtaining a specific license from the department, provided that the following conditions are satisfied: (1) The person maintains an office for directing the licensed activity, and at which radiation safety records are normally maintained, in a location under jurisdiction of the agency which issued the specific license. (2) The license does not limit the authorized activity to specified installations or locations. (3) The person provides written notice to the department at least 3 days prior to engaging in such activity. Such notice shall indicate the location, specific time period, and type of proposed possession and use within this state, and shall be accompanied by a copy of the pertinent license. If, for a specific case, the 3-day period would impose an undue hardship on the person, the person may make application to the department to proceed sooner. (4) The person complies with all applicable regulations of the department and with all the terms and conditions of the license, except such terms and conditions which may be inconsistent with said regulations. (5) The person supplies such other information as the department may request. (6) The person pays a fee in accordance with section 30230(f) to the Department prior to the engagement of activities within the state. (b) Any person who holds a specific license issued by the United States Nuclear Regulatory Commission, or by any other Agreement State or by any state that has been either provisionally or finally designated as a Licensing State by the Conference of Radiation Control Program Directors, Inc., other than this State, authorizing the holder to install or service a device described in section 30192.1(a) shall be issued a general license to install or service such device in this State, provided that the following conditions are satisfied: (1) The person files a report with the department within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this State identifying each device recipient by name and address, the type of device transferred or installed, and the quantity and type of radioactive material contained in each device. (2) The device has been manufactured and labeled and is installed and serviced in accordance with applicable provisions of the specific license. (3) The person assures that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device are affixed and bear a statement that "Removal of this label is prohibited." (4) The person furnishes to each device recipient in this State to whom he or she transfers such a device or on whose premises he or she installs the device, a copy of Group 1.5 of this subchapter, of section 30192.1(a) and (b) of this regulation, and of sections 30253, 30254, 30293(a)(2) and 30295 of Group 3 of this subchapter. (c) The department may withdraw, limit, or qualify its acceptance of any license specified in sections 30225(a) or (b) upon determining that such action is necessary to protect health or to minimize danger to life or property. Note: Authority cited: Sections 100275, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 114985, 114990, 115060, 115065, 115090, 115093, 115105, 115110, 115120, 115165, 115230 and 115235, Health and Safety Code. s 30230. License Fees. (a) Except as provided in subsection (b), each applicant for a specific license pursuant to the provisions of this group shall include with the application a nonrefundable fee, which is equal to the annual fee as set forth in section 30231, and if the specific license is granted, the application fee shall constitute the annual fee for the first year of the license. (b) Each applicant for a specific license for commercial distribution of sealed sources or devices containing sealed sources, who requests evaluation of the information submitted pursuant to section 30195(d)(1) and (d)(2), shall include with the application, a nonrefundable fee, which is equal to the annual fee, and a nonrefundable evaluation fee as set forth in section 30231. If the specific license is granted, the fee equal to the annual fee shall constitute the annual fee for the first year of the license. (c) Each licensee shall pay an annual fee, as set forth in section 30231, on or before the anniversary of the effective date of the license. (d) Each licensee, who applies for an amendment to a specific license that increases the maximum possession limits of the license shall include with the request submitted pursuant to section 30194.2, an additional fee for each such amendment, as set forth in section 30231(c). (e) Each licensee authorized pursuant to section 30195(d) to commercially distribute sealed sources or devices containing sealed sources shall, in addition to the annual fee specified in section 30231(a), pay: (1) The evaluation fees specified in section 30231(f)(1) through (3), specific to the type of evaluation, when a request for evaluation is submitted to the Department; and (2) The annual fee specified in section 30231(f)(4). (f) Each person authorized to conduct activities within the state pursuant to section 30225(a) shall pay a fee as specified in section 30231(e). Note: Authority cited: Sections 100275, 115000, 115060 and 115065, Health and Safety Code. Reference: Sections 114965, 114970, 114980 and 115165, Health and Safety Code. s 30231. Fee Schedule. (a) The annual fee shall be calculated in accordance with the following formula and shall not exceed $25,000.00 for any one license: Annual fee (rounded to the nearest dollar) = A + (A x B x C) Where: A = [Sum of the license fee specified in subsection (b)(1), the fee for unsealed sources specified in subsection (b)(2) and the fee for sealed sources specified in subsection (b)(3)] B = [Number of authorized use locations minus one as specified in subsection (b)(4)] C = [0.2 as specified in subsection (b)(4)]. (b) The annual fee for each specific license shall consist of the following components: (1) A fee of $1,112.00 for each license; (2) A fee for the unsealed sources authorized to be possessed at any one time by the license provided such unsealed sources have a combined total strength of over 10 millicuries (mCi), as follows: Over 10 mCi, but not over 100 mCi.......... $636.00 Over 100 mCi, but not over 500 mCi......... $1,271.00 Over 500 mCi, but not over 1 curie (Ci).... $2,543.00 Over 1 Ci, but not over 10 Ci.............. $3,814.00 Over 10 Ci, but not over 100 Ci............ $5,085.00 Over 100 Ci................................ $6,375.00; (3) A fee for the sealed sources authorized to be possessed at any one time by the license provided such sealed sources have a combined total strength of over 100 mCi, as follows: Over 100 mCi, but not over 1 Ci....... $636.00 Over 1 Ci, but not over 5 Ci.......... $1,271.00 Over 5 Ci, but not over 10 Ci......... $2,543.00 Over 10 Ci, but not over 100 Ci....... $3,814.00 Over 100 Ci, but not over 1,000 Ci.... $5,085.00 Over 1,000 Ci......................... $6,357.00; and (4) A fee for each location of use greater than one, authorized in a specific license pursuant to section 30194.1, which is determined by multiplying the number of authorized use locations minus one by the sum of the values of subsections (b)(1) through (3) and by 0.2. (c) The amount of additional fee required pursuant section 30230(d), except as limited by this section, shall be the difference between the current annual fee and the total annual fees required for the new limits requested. (d) Any licensee who fails to pay the annual fee by the anniversary of the effective date of the license shall immediately cease use of all sources of radiation by placing the sources in storage until such time as the annual fee and a late fee of 25 percent of the annual fee has been paid. (e) The fee for persons authorized to operate under section 30225(a) shall be equal to the annual fee as specified in subsection (a) for the combined total strength of radioactive material that will be possessed while in this state. The fees shall be effective for the period in which reciprocity is granted under section 30225. (f) The fees required by subsections (b) and (e) of section 30230 shall be as follows: (1) $4,270.00 for evaluation of each device and sealed source; (2) $3,270.00 for evaluation of each device only; (3) $1,000.00 for evaluation of each sealed source only; and (4) $400.00, annually, for each registry certificate maintained by the Department indicating that the sealed source or device is commercially manufactured and/or distributed and includes evaluations of modifications of the source or device identified on the certificate. (g) Fees required by this section shall be nonrefundable. Note: Authority cited: Sections 100275, 115000, 115060 and 115065, Health and Safety Code. Reference: Sections 114965, 114970, 114980 and 115165, Health and Safety Code. s 30232. Fee Limitations. Note: Authority cited: Sections 208, 25811 and 25816, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25816, 25875 and 25876, Health and Safety Code. s 30235. Schedule A. Exempt Quantities. Radionuclide Microcuries ------------------------------------------------------------------------------- Antimony-122 (Sb<>122) 100 Antimony-124 (Sb<>124) 10 Antimony-125 (Sb<>125) 10 Arsenic-73 (As<>73) 100 Arsenic-74 (As<>74) 10 Arsenic-76 (As<>76) 10 Arsenic-77 (As<>77) 100 Barium-131 (Ba<>131) 10 Barium-133 (Ba<>133) 10 Barium-140 (Ba<>140) 10 Beryllium-7 (Be<>7) 100 Bismuth-210 (Bi<>210) 1 Bromine-82 (Br<>82) 10 Cadmium-109 (Cd<>109) 10 Cadmium-115m (Cd<>115m) 10 Cadmium-115 (Cd<>115) 100 Calcium-45 (Ca<>45) 10 Calcium-47 (Ca<>47) 10 Carbon-14 (C<>14) 100 Cerium-141 (Ce<>141) 100 Cerium-143 (Ce<>143) 100 Cerium-144 (Ce<>144) 1 Cesium-129 (Cs<>129) 100 Cesium-131 (Cs<>131) 1,000 Cesium-134m (Cs<>134m) 100 Cesium-134 (Cs<>134) 1 Cesium-135 (Cs<>135) 10 Cesium-136 (Cs<>136) 10 Cesium-137 (Cs<>137) 10 Chlorine-36 (Cl<>36) 10 Chlorine-38 (Cl<>38) 10 Chromium-51 (Cr<>51) 1,000 Cobalt-57 (Co<>57) 100 Cobalt-58m (Co<>58m) 10 Cobalt-58 (Co<>58) 10 Cobalt-60 (Co<>60) 1 Copper-64 (Cu<>64) 100 Dysprosium-165 (Dy<>165) 10 Dysprosium-166 (Dy<>166) 100 Erbium-169 (Er<>160) 100 Erbium-171 (Er<>171) 100 Europium-152 9.2h (Eu<>1529.2h) 100 Europium-152 13 yr (Eu<>15213 yr) 1 Europium-154 (Eu<>154) 1 Europium-155 (Eu<>155) 10 Fluorine-18 (F<>18) 1,000 Gadolinium-153 (Gd<>153) 10 Gadolinium-159 (Gd<>159) 100 Gallium-67 (Ga<>67) 100 Gallium-72 (Ga<>72) 10 Germanium-72 (Ge<>71) 100 Gold-198 (Au<>198) 100 Gold-199 (Au<>199) 100 Hafnium-181 (Hf<>181) 10 Holmium-166 (Ho<>166) 100 Hydrogen-3 (H<>3) 1,000 Indium-111 (In<>111) 100 Indium-113 (In<>113) 10 Indium-114 (In<>114) 100 Indium-115 (In<>115) 100 Iodine-123 (I<>123) 100 Iodine-125 (I<>125) 1 Iodine-126 (I<>126) 1 Iodine-129 (I<>129) 0.1 Iodine-131 (I<>131) 1 Iodine-132 (I<>132) 10 Iodine-133 (I<>133) 1 Iodine-134 (I<>134) 10 Iodine-135 (I<>135) 10 Iridium-192 (Ir<>192) 10 Iridium-194 (Ir<>194) 100 Iron-52 (Fe<>52) 10 Iron-55 (Fe<>55) 100 Iron-59 (Fe<>59) 10 Krypton-85 (Kr<>85) 100 Krypton-87 (Kr<>87) 10 Lanthanum-140 (La<>140) 10 Lead-210 (Pb<>210) 0.1 Lutetium-177 (Lu<>177) 100 Manganses-52 (Mn<>52) 10 Manganses-54 (Mn<>54) 10 Manganses-56 (Mn<>56) 10 Mercury-197m (Hg<>197m) 100 Mercury-197 (Hg<>197) 100 Mercury-203 (Hg<>203) 10 Molybdenum-99 (Mo<>99) 100 Neodymium-147 (Nd<>147) 100 Neodymium-149 (Nd<>149) 100 Nickel-59 (Ni<>59) 100 Nickel-63 (Ni<>63) 10 Nickel-65 (Ni<>65) 100 Niobium-93m (Nb<>93m) 10 Niobium-95 (Nb<>95) 10 Niobium-97 (Nb<>97) 10 Osmium-185 (Os<>185) 10 Osmium-191m (Os<>191m) 100 Osmium-191 (Os<>191) 100 Osmium-193 (Os<>193) 100 Palladium-103 (Pd<>103) 100 Palladium-109 (Pd<>109) 100 Phosphorus-32 (P<>32) 10 Platinum-191 (Pt<>191) 100 Platinum-193m (Pt<>193m) 100 Platinum-193 (Pt<>193) 100 Platinum-197m (Pt<>197m) 100 Platinum-197 (Pt<>197) 100 Polonium-210 (Po<>210) 0.1 Potassium-42 (K<>42) 10 Potassium-43 (K<>43) 10 Praseodymium-142 (Pr<>142) 100 Praseodymium-143 (Pr<>143) 100 Promethium-147 (Pm<>147) 10 Promethium-149 (Pm<>149) 10 Rhenium-186 (Re<>186) 100 Rhenium-188 (Re<>188) 100 Rhodium-103m (Rh<>103m) 100 Rhodium-105 (Rh<>105) 100 Rubidium-81 (Rb<>81) 10 Rubidium-86 (Rb<>86) 10 Rubidium-87 (Rb<>87) 10 Ruthenium-97 (Ru<>97) 100 Ruthenium-103 (Ru<>103) 10 Ruthenium-105 (Ru<>105) 10 Ruthenium-106 (Ru<>106) 1 Samarium-151 (Sm<>151) 10 Samarium-153 (Sm<>153) 100 Scandium-46 (Sc<>46) 10 Scandium-47 (Sc<>47) 100 Scandium-48 (Sc<>48) 10 Selenium-75 (Se<>75) 10 Silicon-31 (Si<>31) 100 Silver-105 (Ag<>105) 10 Silver-110m (Ag<>110m) 1 Silver-111 (Ag<>111) 100 Sodium-22 (Na<>22) 1 Sodium-24 (Na<>24) 10 Strontium-85 (Sr<>85) 10 Strontium-89 (Sr<>89) 1 Strontium-90 (Sr<>90) 0.1 Strontium-91 (Sr<>91) 10 Strontium-92 (Sr<>92) 10 Sulphur-35 (s<>35) 100 Tantalum-182 (Ta<>182) 10 Technetuim-96 (Tc<>96) 10 Technetuim-97m (Tc<>97m) 100 Technetuim-97 (Tc<>97) 100 Technetuim-99m (Tc<>99m) 100 Technetuim-99 (Tc<>99) 10 Tellurium-125m (Te<>125m) 10 Tellurium-127m (Te<>127m) 10 Tellurium-127 (Te<>127) 100 Tellurium-129m (Te<>129m) 10 Tellurium-129 (Te<>129) 100 Tellurium-131m (Te<>131m) 10 Tellurium-132 (Te<>132) 10 Terbium-160 (Tb<>160) 10 Thallium-200 (Ti<>200) 100 Thallium-201 (Ti<>201) 100 Thallium-204 (Ti<>204) 10 Thullium-170 (Tm<>170) 10 Thullium-171 (Tm<>171) 10 Tin-113 (Sn<>113) 10 Tin-125 (Sn<>125) 10 Tungsten-181 (W<>181) 10 Tungsten-185 (W<>185) 10 Tungsten-187 (W<>187) 100 Vanadium-48 (V<>48) 10 Xenon-131m (Xe<>131m) 1,000 Xenon-133 (Xe<>133) 100 Xenon-135 (Xe<>135) 100 Ytterbium-175 (Yb<>175) 100 Yttrium-87 (Y<>87) 10 Yttrium-90 (Y<>90) 10 Yttrium-91 (Y<>91) 10 Yttrium-92 (Y<>92) 100 Yttrium-93 (Y<>93) 100 Zinc-65 (Zn<>65) 10 Zinc-69m (Zn<>69m) 100 Zinc-69 (Zn<>69) 1,000 Zirconium-93 (Zr<>93) 10 Zirconium-95 (Zr<>95) 10 Zirconium-97 (Zr<>97) 10 Any radionuclide not listed above other than alpha emitting 0.1 radionuclides Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115165, 115230 and 115235, Health and Safety Code. s 30236. Schedule B, Table I, In Vitro Clinical Tests. Maximum Maximum Microcuries Microcuries Radionuclide Per Unit Total Hydrogen 3 50 2,000 Carbon 14 10 2,000 Iron 59 20 200 Selenium 75 10 200 Cobalt 57 10 200 Iodine 125 or Idione 131 10 200 Mock Iodine 125 Reference source Iodine 129 0.05 -- Americium 241 0.005 -- Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25855, 25875 and 25876, Health and Safety Code. s 30237. Schedule C. Column I Column II Gas Liquid and solid concentration concentration Element (atomic number) Isotope (<> (<> Ci/ml [FN2] Ci/ml [FN1] _______________________________________________________________________________ Antimony (51)........ Sb <>122 .............. 3 x 10 <>-4 Sb <>124 .............. 2 x 10 <>-4 Sb <>125 .............. 1 x 10 <>-3 Argon (18)........... Ar <>37 1 x 10 ...................... <>-3 Ar <>41 4 x 10 ...................... <>-7 Arsenic (33)......... As <>73 .............. 5 x 10 <>-3 As <>74 .............. 5 x 10 <>-4 As <>76 .............. 2 x 10 <>-4 As <>77 .............. 8 x 10 <>-4 Barium (56).......... Ba <>131 .............. 2 x 10 <>-3 Ba <>140 .............. 3 x 10 <>-4 Beryllium (4)........ Be <>7 .............. 2 x 10 <>-2 Bismuth (83)......... Bi <>206 .............. 4 x 10 <>-4 Bromine (35)......... Br <>42 4 x 10 3 x 10 <>-2 <>-7 Cadmium (48)......... Cd <>109 .............. 2 x 10 <>-2 Cd <>115m .............. 3 x 10 <>-4 Cd <>113 .............. 3 x 10 <>-4 Calcium (20)......... Ca <>45 .............. 9 x 10 <>-3 Ca <>47 .............. 5 x 10 <>-4 Carbon (6)........... C <>14 1 x 10 8 x 10 <>-3 <>-6 Cerium (58).......... Ce <>141 .............. 9 x 10 <>-4 Ce <>143 .............. 4 x 10 <>-4 Ce <>144 .............. 1 x 10 <>-4 Cesium (55).......... Cs <>131 .............. 2 x 10 <>-2 Cs <>134m .............. 6 x 10 <>-2 Cs <>134 .............. 9 x 10 <>-3 Chlorine (17)........ Cl <>36 9 x 10 4 x 10 <>-3 <>-7 Chromium (24)........ Cr <>51 .............. 2 x 10 <>-2 Cobalt (27).......... Co <>57 .............. 5 x 10 <>-3 Co <>58 .............. 1 x 10 <>-3 Co <>60 .............. 5 x 10 <>-4 Copper (29).......... Cu <>64 .............. 3 x 10 <>-3 Dysprosium (66)...... Dy <>165 .............. 4 x 10 <>-3 Dy <>166 .............. 4 x 10 <>-4 Erbium (68).......... Er <>169 .............. 9 x 10 <>-4 Er <>171 .............. 1 x 10 <>-3 Europium (63)........ Eu <>162 .............. 6 x 10 <>-4 (T/2=9.2 Hrs.) .............. ...................... Eu <>158 .............. 2 x 10 <>-3 Fluorine (9)......... F <>18 2 x 10 8 x 10 <>-3 <>-6 Gadolinium (64)...... Gd <>153 .............. 2 x 10 <>-3 Gd <>159 .............. 8 x 10 <>-4 Gallium (31)......... Ga <>72 .............. 4 x 10 <>-4 Germanium (32)....... Ge <>71 .............. 2 x 10 <>-2 Gold (79)............ Au <>196 .............. 2 x 10 <>-2 Au <>198 .............. 5 x 10 <>-4 Au <>199 .............. 2 x 10 <>-2 Hafnium (72)......... Hf <>181 .............. 7 x 10 <>-4 Hydrogen (1)......... H <>3 5 x 10 3 x 10 <>-2 <>-6 Indium (49).......... In <>113m .............. 1 x 10 <>-2 In <>114m .............. 2 x 10 <>-4 Iodine (53).......... I <>126 3 x 10 2 x 10 <>-5 <>-9 I <>131 3 x 10 2 x 10 <>-3 <>-9 I <>132 8 x 10 6 x 10 <>-4 <>-8 I <>133 1 x 10 7 x 10 <>-3 <>-8 I <>134 2 x 10 1 x 10 <>-3 <>-7 Iridium (77)......... Ir <>190 .............. 2 x 10 <>-3 Ir <>192 .............. 4 x 10 <>-4 Ir <>194 .............. 3 x 10 <>-4 Iron (26)............ Fe <>53 .............. 8 x 10 <>-2 Fe <>59 .............. 6 x 10 <>-4 Krypton (36)......... Kr <>86m 1 x 10 ...................... <>-6 Kr <>88 3 x 10 ...................... <>-6 Lanthanum (57)....... La <>140 .............. 2 x 10 <>-4 Lead (82)............ Pb <>203 .............. 4 x 10 <>-3 Lutetium (71)........ Lu <>177 .............. 1 x 10 <>-3 Manganese (25)....... Mn <>52 .............. 3 x 10 <>-4 Mn <>54 .............. 1 x 10 <>-3 Mn <>56 .............. 1 x 10 <>-3 Mercury (80)......... Hg <>197m .............. 2 x 10 <>-3 Hg <>197 .............. 3 x 10 <>-3 Hg <>203 .............. 2 x 10 <>-4 Molybdenum (42)...... Mo <>99 .............. 2 x 10 <>-3 Neodymium (60)....... Nd <>147 .............. 6 x 10 <>-4 Nd <>149 .............. 3 x 10 <>-3 Nickel (28).......... Ni <>66 .............. 1 x 10 <>-3 Niobium Nb <>95 .............. 1 x 10 <>-3 (columbium)(41).... Nb <>97 .............. 9 x 10 <>-3 Osmium (76).......... Os <>185 .............. 7 x 10 <>-4 Os <>191m .............. 3 x 10 <>-2 Os <>191 .............. 2 x 10 <>-3 Os <>193 .............. 6 x 10 <>-4 Palladium (46)....... Pd <>103 .............. 3 x 10 <>-3 Pd <>109 .............. 9 x 10 <>-4 Phosphorus (15)...... P <>32 .............. 2 x 10 <>-4 Platinum (78)........ Pt <>191 .............. 1 x 10 <>-3 Pt <>193m .............. 1 x 10 <>-2 Pt <>197m .............. 1 x 10 <>-2 Pt <>197 .............. 1 x 10 <>-3 Polonium (84)........ Po <>210 .............. 7 x 10 <>-4 Potassium (19)....... K <>42 .............. 3 x 10 <>-3 Praseodymium (59).... Pr <>142 .............. 3 x 10 <>-4 Pr <>143 .............. 5 x 10 <>-4 Promethium (61)...... Pm <>147 .............. 2 x 10 <>-3 Pm <>149 .............. 4 x 10 <>-4 Radium (88).......... Ra <>223 .............. 1 x 10 <>-7 Radon (86)........... Rn <>230 1 x 10 ...................... <>-7 Rn <>222 1 x 10 ...................... <>-8 Rhenium (75)......... Re <>183 .............. 6 x 10 <>-3 Re <>185 .............. 9 x 10 <>-4 Re <>188 .............. 6 x 10 <>-4 Rhodium (45)......... Rh <>103m .............. 1 x 10 <>-1 Rh <>105 .............. 1 x 10 <>-3 Rubidium (37)........ Rb <>85 .............. 7 x 10 <>-4 Ruthenium (44)....... Ru <>97 .............. 4 x 10 <>-3 Ru <>103 .............. 8 x 10 <>-4 Ru <>105 .............. 1 x 10 <>-3 Ru <>106 .............. 1 x 10 <>-4 Samarium (62)........ Sm <>133 .............. 8 x 10 <>-4 Scandium (21)........ Sc <>45 .............. 4 x 10 <>-4 Sc <>47 .............. 9 x 10 <>-4 Sc <>48 .............. 3 x 10 <>-4 Selenium (34)........ Se <>73 .............. 3 x 10 <>-2 Silicon (14)......... Si <>31 .............. 9 x 10 <>-2 Silver (47).......... Ag <>105 .............. 1 x 10 <>-3 Ag <>110m .............. 3 x 10 <>-4 Ag <>111 .............. 4 x 10 <>-4 Sodium (11).......... Na <>24 .............. 2 x 10 <>-3 Strontium (38)....... Sr <>85 .............. 1 x 10 <>-3 Sr <>89 .............. 1 x 10 <>-4 Sr <>91 .............. 7 x 10 <>-4 Sr <>92 .............. 7 x 10 <>-4 Sulfur (16).......... S <>35 9 x 10 6 x 10 <>-8 <>-8 Tantalum (73)........ Ta <>182 .............. 4 x 10 <>-4 Technetium (43)...... Tc <>99m .............. 1 x 10 <>-1 Tc <>98 .............. 1 x 10 <>-3 Tellurium (52)....... Te <>125m .............. 2 x 10 <>-3 Te <>127m .............. 6 x 10 <>-4 Te <>127 .............. 3 x 10 <>-3 Te <>129m .............. 3 x 10 <>-4 Te <>131m .............. 6 x 10 <>-4 Te <>132 .............. 3 x 10 <>-4 Terbium (65)......... Tb <>169 .............. 4 x 10 <>-4 Thallium (81)........ Tl <>200 .............. 4 x 10 <>-3 Tl <>201 .............. 5 x 10 <>-2 Tl <>202 .............. 1 x 10 <>-3 Tl <>204 .............. 1 x 10 <>-3 Thulium (69)......... Tm <>170 .............. 5 x 10 <>-4 Tm <>171 .............. 5 x 10 <>-3 Tin (50)............. Sn <>113 .............. 9 x 10 <>-4 Sn <>123 .............. 2 x 10 <>-4 Tungsten W <>181 .............. 4 x 10 <>-3 (wolfram)(74)...... W <>187 .............. 7 x 10 <>-4 Vanadium (23)........ V <>48 .............. 3 x 10 <>-4 Xenon (54)........... Xe <>131m 4 x 10 ...................... <>-6 Xe <>133 3 x 10 ...................... <>-6 Xe <>135 1 x 10 ...................... <>-6 Ytterbium (70)....... Yb <>173 .............. 1 x 10 <>-3 Yttrium (39)......... Y <>90 .............. 2 x 10 <>-4 Y <>91m .............. 3 x 10 <>-3 Y <>91 .............. 3 x 10 <>-4 Y <>92 .............. 6 x 10 <>-4 Y <>93 .............. 3 x 10 <>-4 Zinc (30)............ Zn <>65 .............. 1 x 10 <>-3 Zn <>69m .............. 7 x 10 <>-4 Zn <>69 .............. 2 x 10 <>-2 Zirconium (40)....... Zr <>95 .............. 6 x 10 <>-4 Zr <>97 .............. 2 x 10 <>-4 Beta and/or gamma emitting radioactive material not listed above with half-life less than 3 years 1 x 10 1 x 10 <>-6 <>-10 Note: 1: Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in Schedule C, the activity stated is that of the parent isotope and takes into account the daughters. Note: 2: Where there is involved a combination of isotopes, the limit for the combination should be derived as follows: Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule C for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e. unity). Example: TABULAR OR GRAPHIC MATERIAL SET FORTH AT THIS POINT IS NOT DISPLAYABLE Concentration of Isotope A in Product Concentrate of Isotope B in Product = _____________________________________ + ________________________________ <1 Exempt concentration of Isotope A Exempt concentration of Isotope B [FN1] Values are given only for those materials normally used as gases. [FN2] uCi/gm for solids. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 115165, 115230 and 115235, Health and Safety Code. s 30250. Authority. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30251. Purpose. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30252. Scope and Purpose. (a) Group 3 regulations apply to all persons who possess sources of radiation, except as exempt from the licensing and registration requirements or otherwise specifically exempted by the provisions of Group 1 and Group 2 of this subchapter. (b) The limits in Group 3 do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30253. Standards for Protection Against Radiation. (a) The regulations governing standards for protection against radiation in title 10, Code of Federal Regulations, part 20, (10 CFR 20) sections 20.1001 through 20.2402 and Appendices A through G, (January 1, 2005) are hereby incorporated by reference with the following exceptions: (1) Title 10, Code of Federal Regulations, sections 20.1001, 20.1002, 20.1006, 20.1007, 20.1008, 20.1009, 20.1401, 20.1402, 20.1403, 20.1404, 20.1405, 20.1406, 20.2106(d), 20.2302, 20.2401, and 20.2402, and Appendix D are not incorporated by reference. (2) Any references to the United States Nuclear Regulatory Commission (NRC) or any component thereof shall be deemed to be a reference to State Department of Health Services. (3) The definition of the term "Byproduct material" in 10 CFR 20, section 20.1003 is modified to mean any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to, the process of producing or utilizing special nuclear material. (4) The definition of the term "License" in 10 CFR 20, section 20.1003 is replaced by the definition of the term "License" as defined in section 30100 of this regulation. (5) The definition of the term "Licensed material" in 10 CFR 20, section 20.1003 is modified to mean any radioactive material including source material, special nuclear material, or byproduct material received, possessed, used, transferred or disposed of under a general or specific license issued by the NRC, or by any other Agreement State or by any state that has been either provisionally or finally designated as a Licensing State by the Conference of Radiation Control program Directors, Inc. With respect to dose limits and reporting requirements, the term "Licensed material" is to be construed broadly in context to include any source of ionizing radiation subject to the requirements of this regulation. (6) The definition of the term "Licensee" as defined in 10 CFR 20, section 20.1003 is replaced by the definition of the term "User" as set forth in section 30100 of this regulation. (7) The definition of the term "Person" as defined in 10 CFR 20, section 20.1003 is replaced by the definition of the term "Person" as set forth in section 114985(c) of the Health and Safety Code. (8) The definition of the term "Radiation (ionizing radiation)" as defined in 10 CFR 20, section 20.1003 is replaced by the definition of the term "Ionizing radiation" as set forth in section 114985(b) of the Health and Safety Code. (9) The definition of the term "Special nuclear materials" as defined in 10 CFR 20, section 20.1003 is replaced by the definition of the term "Special nuclear material" as set forth in section 114985(f) of the Health and Safety Code. (b) The terms defined in 10 CFR 20, section 20.1003, as incorporated by reference, shall apply to this regulation, except that: (1) The term "Act" as defined in 10 CFR 20, section 20.1003 is limited to the textual material incorporated by reference in subsection (a) above. The meaning of the term "Act" elsewhere in this regulation, means the "Radiation Control Law," Health and Safety Code, Division 104, Part 9, chapter 8, sections 114960 et seq. (2) The term "Department" as defined in 10 CFR 20, section 20.1003 is limited to the provisions incorporated by reference in subsection (a). The meaning of the term "Department" elsewhere in this regulation, is as defined in section 114985(j) of the Health and Safety Code. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114960, 114965, 114970, 114985, 114990, 115060, 115105, 115110, 115120, 115165, 115230 and 115235, Health and Safety Code. s 30254. Inspection. (a) Each user shall afford to the Department or other official agency specifically designated by the Department, at all reasonable times, opportunity to inspect materials, machines, activities, facilities, premises, and records pursuant to these regulations. (b) During an inspection, inspectors may consult privately with workers as specified below. The user may accompany inspectors during other phases of an inspection. (1) Inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of Department regulations and licenses to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection. (2) During the course of an inspection any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which he has reason to believe may have contributed to or caused any violation of the Radiation Control Law, these regulations, or license condition, or any unnecessary exposure of an individual to radiation from licensed radioactive material or a registered radiation machine under the user's control. Any such notice in writing shall comply with the requirements of subsection (h) hereof. (3) The provision of paragraph (b)(2) of this section shall not be interpreted as authorization to disregard instructions pursuant to Section 30255(b)(1). (c) If, at the time of inspection, an individual has been authorized by the workers to represent them during inspections, the user shall notify the inspectors of such authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions. (d) Each worker's representative shall be routinely engaged in work under control of the user and shall have received instructions as specified in Section 30280(b)(1). (e) Different representatives of users and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany the inspectors. (f) With the approval of the user and the workers' representative, an individual who is not routinely engaged in work under control of the user, for example, a consultant to the user or to the workers' representative, shall be afforded the opportunity to accompany inspectors during the inspection of physical working conditions. (g) Notwithstanding the other provisions of this section, inspectors are authorized to refuse to permit accompaniment by an individual who deliberately interferes with a fair and orderly inspection. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the user to enter that area. (h) Any worker or representative of workers who believes that a violation of the Radiation Control Law, these regulations or license conditions exists, or has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the Department or other official agency specifically designated by the Department. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the user by the Department no later than at the time of inspection except that, upon the request of the worker giving such notice, his name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the Department except for good cause shown. (i) If, upon receipt of such notice, the Chief, Radiologic Health Branch, of the Department, determines that the complaint meets the requirements set forth in subsection (h) hereof, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, he shall cause an inspection to be made as soon as practicable, to determine if such alleged violation exists or has occurred. Inspections pursuant to this section need not be limited to matters referred to in the complaint. (j) No user shall discharge or in any manner discriminate against any worker because such worker has filed any complaint or instituted or caused to be instituted any proceeding under these regulations or has testified or is about to testify in any such proceeding or because of the exercise by such worker on behalf of himself or others of any option afforded by this section. (k) If the Chief, Radiologic Health Branch, of the Department, determines with respect to a complaint under subsection (h) hereof that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the complainant shall be notified in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position to the Director of the Department, who will provide the user with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The user may submit an opposing written statement of position with the Director of the Department who will provide the complainant with a copy of such statement by certified mail. Upon the request of the complainant, the Director of the Department, or his designee, may hold an informal conference in which the complainant and the user may orally present their views. An informal conference may also be held at the request of the user, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written or oral views presented, the Director of the Department shall affirm, modify, or reverse the determination of the Chief, Radiologic Health Branch, of the Department, and furnish the complainant and the user a written notification of his decision and the reason therefor. ( l) If the Department determines that an inspection is not warranted because the requirements of subsection (h) hereof have not been met, it shall notify the complainant in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of subsection (h) hereof. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30255. Notices, Instructions, and Reports to Personnel. (a) This section establishes requirements for notices, instructions, and reports by users to individuals engaged in work under a license or registration and options available to such individuals in connection with Department inspections of licensees or registrants to ascertain compliance with the provisions of the Radiation Control Law and regulations, orders, and licenses issued thereunder regarding radiological working conditions. The requirements in this section apply to all persons who receive, possess, use, own or transfer material licensed by or registered with the Department. (b) Each user shall: (1) Inform all individuals working in or frequenting any portion of a controlled area of the storage, transfer, or use of radioactive materials or of radiation in such portions of the controlled area; instruct such individuals in the health protection problems associated with exposure to such radioactive materials or radiation, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed; instruct such individuals in, and instruct them to observe, to the extent within their control, the applicable provisions of Department regulations and license conditions for the protection of personnel from exposures to radiation or radioactive materials occurring in such areas; instruct such individuals of their responsibility to report promptly to the licensee or registrant any condition which may lead to or cause a violation of department regulations or license conditions or unnecessary exposure to radiation or radioactive material, and of the inspection provisions of Section 30254; instruct such individuals in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive materials; and advise such individuals as to the radiation exposure reports which they may request pursuant to this section. The extent of these instructions shall be commensurate with potential radiological health protection problems in the controlled area. (2) Conspicuously post a current copy of this regulation, a copy of applicable licenses for radioactive material, and a copy of operating and emergency procedures applicable to work with sources of radiation. If posting of documents specified in this paragraph is not practicable the user may post a notice which describes the document and states where it may be examined. (3) Conspicuously post a current copy of Department Form RH-2364 (Notice to Employees) in a sufficient number of places to permit individuals working in or frequenting any portion of a controlled area to observe a copy on the way to or from such area. (4) Conspicuously post any notice of violation involving radiological working conditions or any order issued pursuant to the Radiation Control Law and any required response from the user. Department documents posted pursuant to this paragraph shall be posted within two working days after receipt of the documents from the Department; the user's response, if any, shall be posted within two working days after dispatch by the user. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later. (5) Assure that documents, notices, or forms posted pursuant to this section shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered. (6) Provide reports to any individual of his radiation exposure data and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of that individual as specified in this section. The information reported shall include data and results obtained pursuant to Department regulations, orders, or license conditions, as shown in records maintained by the user pursuant to Department regulations. Each notification and report shall: be in writing; include appropriate identifying data such as the name of the user, the name of the individual, the individual's Social Security number; include the individual's exposure information; and contain the following statement: "This report is furnished to you under the provisions of the California State Department of Health Services Regulations: Standards for Protection Against Radiation. You should preserve this report for future reference." These reports shall be provided as follows: (A) At the request of any individual, each user shall advise such individual annually of his exposure to radiation or radioactive material as shown in records maintained by the licensee or registrant pursuant to United States, title 10, Code of Federal Regulations, part 20, subpart M as incorporated by reference in section 30253, including the results of any calculations and analyses of radioactive material deposited in the body of the individual. (B) At the request of an individual formerly engaged in work controlled by the user, the user shall furnish to the individual a report of his exposure to radiation or radioactive material. Such report shall be furnished within 30 days from the time the request is made, or within 30 days after the exposure of the individual has been determined by the user, whichever is later; shall cover, within the period of time specified in the request, each calendar quarter in which the individual's activities involved exposure to radiation from radioactive materials licensed by, or radiation machines registered with the Department; and shall include the dates and locations of work under the license or registration in which the individual participated during this period. (C) When a user is required pursuant to United States, title 10, Code of Federal Regulations, part 20, subpart M as incorporated by reference in section 30253 to report to the Department any exposure of an individual to radiation or radioactive material, the user shall also provide the individual a report on his exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the Department. (D) At the request of an individual who is terminating employment or assignment to work involving radiation exposure in the user's facility in a given calendar quarter, the user shall furnish to the individual a written report of the individual's exposure to radiation or radioactive material received during that specifically identified calendar quarter. Such report shall contain an estimate of exposures if the final reports are not available at the time of termination. Estimated exposures shall be clearly indicated as such. Note: Authority cited: Section 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25826, 25875 and 25876, Health and Safety Code. s 30256. Vacating Installations: Records and Notice. (a) Each person granted a specific license pursuant to Group 2 of this Subchapter shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use by the Department. Before licensed activities are transferred or assigned in accordance with 30194(c), licensees shall transfer all records described in this section to the new licensee. In this case, the new licensee shall be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. The records shall include the following information important to decommissioning: (1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records shall include but not be limited to a description of any instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas, as for example, possible seepage into porous materials such as concrete. These records shall include any known information on identification of involved nuclides, quantities, forms, and concentrations. (2) As-built drawings and modification drawings of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations. (3) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after any leak) or any radioactive materials having only half-lives of less than 65 days, a list contained in a single document and updated every 2 years, of the following: (A) All areas designated and formerly designated restricted areas as defined in Title 10, Code of Federal Regulations, Section 20.1003 incorporated by reference pursuant to Title 17, California Code of Regulations, Section 30253; (B) All areas outside restricted areas that require documentation under (a)(1); (C) All areas outside of restricted areas where current and previous wastes have been buried as documented under Title 10, Code of Federal Regulations, Section 20.2108 incorporated by reference pursuant to Title 17, California Code of Regulations, Section 30253; and (D) All areas outside of restricted areas which contain material such that, if the license expired, the licensee would be required to either decontaminate the area to unrestricted release levels or apply for approval for disposal under Title 10, Code of Federal Regulations, Section 20.2002 incorporated by reference pursuant to Title 17, California Code of Regulations, Section 30253. (4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used pursuant to Section 30195.1. (b) Each person granted a specific license pursuant to Group 2 of this Subchapter shall, no less than 30 days before vacating any installation which may have been contaminated with radioactive material as a result of his activities, notify the department in writing of intent to vacate. This notice shall be submitted on form RHB 314 (12/95) entitled "Certificate of Disposition of Materials" which is incorporated by reference herein and shall address all requirements specified in Subsection (c). (c) If a licensee does not submit an application for license renewal under section 30194, the licensee shall on or before the expiration date specified in the license: (1) Terminate use of radioactive material; (2) Remove radioactive contamination to the extent practicable except for those procedures covered by Subsection (d) of this section; (3) Dispose of radioactive material in accordance with applicable regulations; (4) Submit a completed form RHB 314 (12/95), which certifies information concerning the disposition of materials; and (5) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates that the premises are suitable for release for unrestricted use in some other manner. The licensee shall, as appropriate: (A) Report levels of radiation in units of microrads per hour of beta and gamma radiation at one centimeter and gamma radiation at one meter from surfaces, and report levels of radioactivity, including alpha, in units of disintegrations per minute (or microcuries) per 100 square centimeters removable and fixed for surfaces, microcuries per milliliter for water, and picocuries per gram for solids such as soils or concrete; and (B) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested. (d) In addition to the information required under Subsections (c)(4) and (5), the licensee shall submit a plan for completion of decommissioning if the procedures necessary to carry out decommissioning have not been previously approved by the Department and could increase potential health and safety impacts to workers or to the public such as in any of the following cases: (1) Procedures would involve techniques not applied routinely during cleanup or maintenance operations; or (2) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation; or (3) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or (4) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation. (e) Procedures with potential health and safety impacts shall not be carried out prior to approval of the decommissioning plan. (f) The proposed decommissioning plan, if required by Subsection (d) of this section or by license condition, shall include: (1) Description of planned decommissioning activities; (2) Description of methods used to assure protection of workers and the environment against radiation hazards during decommissioning; (3) A description of the planned final radiation survey; (4) The information required in (a) (3) and any other information required by (a) that is considered necessary to support the adequacy of the decommissioning plan for approval; and (5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and plan for assuring the availability of adequate funds for completion of decommissioning. (g) The proposed decommissioning plan will be approved by the Department if the Department determines that the decommissioning will be completed as soon as is reasonable and that the health and safety of workers and the public will be adequately protected. (h) Upon approval of the decommissioning plan by the Department, the licensee shall complete decommissioning in accordance with the approved plan. As a final step in decommissioning, the licensee shall again submit the information required in Subsection (c)(5) and shall certify the disposition of accumulated wastes from decommissioning by completing form RHB 314 (12/95). (i) If the information submitted under subsection (c)(5) or (h) does not adequately demonstrate that the premises are suitable for release for unrestricted use, the Department shall inform the licensee of the appropriate further actions required for termination of license. (j) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of residual radioactive material present as contamination until the Department notifies the licensee in writing that the license is terminated. During this time, the licensee shall: (1) Limit actions involving radioactive material to those related to decommissioning; and (2) Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the Department notifies the licensee in writing that the license is terminated. (k) Specific licenses shall be terminated by written notice to the licensee when the Department determines that: (1) Radioactive material has been properly disposed; (2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and (3) A radiation survey has been performed which demonstrates that the premises are suitable for release for unrestricted use; or other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release for unrestricted use. Note: Authority cited: Sections 100275, 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code. s 30257. Bankruptcy Notification. (a) Each licensee shall notify the Department in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter or title 11 (Bankruptcy) of the United States Code (11 U.S.C.) by or against: (1) Any licensee; (2) An entity (as that term is defined in 11 U.S.C. 101 (14)) controlling the licensee or listing the license as property of the estate; or (3) An affiliate (as that term is defined in 11 U.S.C. 101 (2)) of the license. (b) This notification must indicate: (1) The bankruptcy court in which the petition for bankruptcy was filed; and (2) The date of the filing of the petition. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 28501, 28502, 25815, 25860, 25863, 25875 and 25876, Health and Safety Code. s 30258. General Definitions. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30265. Occupational Dose Limits. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30265.1. Determination of Prior Dose. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30266. Exposure of Individuals to Concentrations of Radioactive Material in Controlled Areas. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health ad Safety Code. s 30268. Permissible Levels of Radiation in Uncontrolled Areas. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30269. Concentrations in Effluents to Uncontrolled Areas. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30275. Surveys and Tests. (a) Each user shall make or cause to be made such surveys as are necessary for compliance with all provisions of this regulation. (b) Upon instruction from the Department or other official agency specifically designated by the Department, each user shall perform or cause to have performed, and shall permit the Department or said agency to perform, such reasonable tests as the Department or said agency deems necessary for the protection of life, health, or property, including, but not limited to, tests of: (1) Sources of radiation. (2) Facilities wherein sources of radiation are used or stored. (3) Radiation detection and monitoring instruments. (4) Other equipment and devices used in connection with utilization or storage of sources of radiation. (c) Each sealed source other than sources listed below, shall be tested for contamination prior to initial use and for leakage at least every six months: (1) Hydrogen-3 or krypton-85 sources. (2) Sealed sources containing licensed radioactive material in gaseous form. (3) Source material. (4) Sources containing radioactive material with a half life of 30 days or less. (5) Sources of beta- and/or gamma-emitting radioactive material with an activity of 100 microcuries or less. (6) Sources of alpha and/or neutron-emitting radioactive material with an activity of 10 microcuries or less. In the absence of a certificate from a transferor indicating that a test has been made prior to the transfer, the sealed source shall not be put into use until tested. If there is reason to suspect that a source might have been damaged, it shall be tested for leakage before further use. Contamination and leak tests shall be capable of determining the presence of 0.005 microcuries of removable contamination. When any contamination or leak test reveals the presence of 0.005 microcuries or more of removable contamination the user shall immediately withdraw the source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with applicable provisions of Group 2 of this subchapter. Two copies of a report shall be filed, within 5 days of the test, with the Department or other official agency specifically designated by the Department, describing the source involved, the test results, and the corrective action taken. (d) The test sample shall be taken from the surface of the source, or source holder, or from the surface of the device in which the source is stored or mounted and on which one might expect contamination to accumulate. Where sealed sources are permanently mounted in devices or equipment, alternate tests for contamination and leakage may be approved by the Department. (e) Tests for contamination and leakage, decontamination, and repair of sealed sources shall be performed only by persons specifically authorized by the Department to do so in accordance with provisions of Group 2 of this subchapter. (f) Records of leak tests shall be maintained as specified in United States, title 10, Code of Federal Regulations, part 20, subpart L as incorporated by reference in section 30253.. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30276. Personnel Monitoring. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30277. Bio-Assays and Medical Review. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30278. Caution Signs and Labels. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30278.1. Removal of Caution Labels from Empty Containers. Each user shall, prior to disposal of an empty uncontaminated container to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code; and 10 CFR 20. 203 (f)(4) (43 FR 22171). s 30279. Special Requirements for High Radiation Areas and Radiation Machines Capable of Producing High Radiation Areas. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30279.1. Additional Special Requirements for Very High Radiation Areas. Note: (1) Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25875 and 25876, Health and Safety Code. s 30280. Notices, Instructions, and Reports to Personnel. Note: Authority cited: Section 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25826, 25875 and 25876, Health and Safety Code. s 30281. Storage and Control of Radioactive Material. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25875 and 25876, Health and Safety Code. s 30282. Procedures for Opening Packages. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30285. General Requirement. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25812 and 25815, Health and Safety Code. s 30287. Disposal by Release into Sanitary Sewerage Systems. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30288. Disposal by Burial in Soil. s 30289. Treatment or Disposal by Incineration. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30293. Records. (a) Each user shall keep records showing the receipt, transfer, and disposal of each source of radiation which is subject to licensure or registration pursuant to groups 1.5 and 2 of this subchapter as follows: (1) The user shall retain each record of receipt of a source of radiation as long as the source of radiation is possessed and for three years following transfer or disposal of the source of radiation. (2) The user who transferred the source of radiation shall retain each record of transfer for three years after each transfer unless a specific requirement in another part of the regulations in this subchapter dictates otherwise. (3) The user who disposed of the radioactive material shall retain each record of disposal of the radioactive material until the Department terminates each license that authorizes disposal of the radioactive material. (b) The user shall retain each record that is required by the regulations in this subchapter or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by regulation or license condition, the record shall be retained until the Department terminates each license that authorizes the activity that is subject to the recordkeeping requirement. (c) Records which shall be maintained pursuant to this subchapter may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by department regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, shall include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. (d) If there is a conflict between the Department's regulations in this subchapter, license condition, or other written Department approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the regulations in this subchapter for such records shall apply unless the Department, pursuant to 30104, has granted a specific exemption from the record retention requirements specified in the regulations in this subchapter. (e) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall, if requested by the Department, forward the following records to the Department: (1) Records of disposal of licensed material made under Title 10, Code of Federal Regulations, sections 20.2002, 20.2003, 20.2004, 20.2005, incorporated by reference in section 30253; and (2) Records required by Title 10, Code of Federal Regulations section 20.2103(b)(4), incorporated by reference in section 30253. (f) If licensed activities are transferred or assigned in accordance with section 30194(c), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated: (1) Records of disposal of licensed material made under Title 10, Code of Federal Regulations, sections 20.2002, 20.2003, 20.2004, 20.2005, incorporated by reference in section 30253; and (2) Records required by Title 10, Code of Federal Regulations, section 20.2103(b)(4), incorporated by reference in section 30243. (g) Prior to license termination, each licensee shall, if requested by the Department, forward the records required by section 30256(a) to the Department. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code. s 30294. Reports of Theft or Loss of Sources of Radiation. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30295. Notification of Incidents. (a) Each user shall notify the Department as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits. (b) Each user shall notify the Department within 24 hours after the discovery of any of the following events involving radiation or radioactive materials: (1) An unplanned contamination event involving licensed radioactive material that: (A) Requires access to the contaminated area by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area; (B) Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B of Title 10, Code of Federal Regulations, part 20, incorporated by reference in section 30253 of this regulation for the material; and (C) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination. (2) An event in which equipment is disabled or fails to function as designed when: (A) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident; (B) The equipment is required to be available and operable when it is disabled or fails to function; and (C) No redundant equipment is available and operable to perform the required safety function. (3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body. (4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when: (A) The quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix B of Title 10, Code of Federal Regulations, part 20, incorporated by reference in section 30253 of this regulation for the material; and (B) The damage affects the integrity of the licensed material or its container. (C) Reports made by users in response to the requirements of this section shall be made as follows: (1) Users shall make reports required by subsections (a) and (b) of this section by telephone to the Department. To the extent that the information is available at the time of notification, the information provided in these reports shall include: (A) The caller's name and call back telephone number; (B) A description of the event, including date and time; (C) The exact location of the event; (D) The isotopes, quantities, and chemical and physical form of the licensed material involved; and (E) Any personnel radiation exposure data available. (2) Written report. Each user who makes a report required by subsection (a) or (b) of this section shall submit a written follow-up report within 30 days of the initial report. These written reports shall be sent to the Department. The reports shall include the following: (A) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; (B) The exact location of the event; (C) The isotopes, quantities, and chemical and physical form of the licensed material involved; (D) Date and time of the event; (E) Corrective actions taken or planned and the results of any evaluation or assessment; and (F) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code. s 30297. Reports of Overexposures and Excessive Levels and Concentrations. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30298. Vacating Installations. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30299. Bankruptcy Notification. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 28501, 28502, 25815, 25860, 25863, 25875 and 25876, Health and Safety Code. s 30305. General Provisions. (a)(1) This article pertains to use of X-rays in medicine, dentistry, osteopathy, chiropractic, podiatry, and veterinary medicine. The provisions of this article are in addition to, and not in substitution for, other applicable provisions of this regulation and of Group 1 of this subchapter. (2) Any existing machine or installation need not be replaced or substantially modified to conform to the requirements of this regulation provided that the user demonstrates to the Department's satisfaction achievement of equivalent protection through other means. (3) No person shall make, sell, lease, transfer, lend, or install X-ray or fluoroscopic equipment or the supplies used in connection with such equipment unless such supplies and equipment, when properly placed in operation or properly used, will meet the requirements of this regulation. This includes responsibility for the delivery of cones or collimators, filters, adequate timers and fluoroscopic shutters (where applicable). (4) For X-ray equipment manufactured after July 31, 1974, the user shall provide sufficient maintenance to keep the equipment in compliance with all applicable radiation protection sections of the Code of Federal Regulations, Title 21, Chapter 1, Subchapter J, Part 1020, Sections 1020.30, 1020.31, and 1020.32. (5) Each installation shall be provided with such primary barriers and/or secondary barriers as are necessary to ensure compliance with Sections 30265 and 30268. Special requirements are contained in Title 24, California Code of Regulations, Sections 2-9102 through 2-9105. (b) Use. (1) The user shall assure that all X-ray equipment under his jurisdiction is operated only by persons adequately instructed in safe operating procedures and competent in safe use of the equipment. (2) The user shall provide safety rules to each individual operating X-ray equipment under his control, including any restrictions of the operating technique required for the safe operation of the particular X-ray apparatus, and require that the operator demonstrate familiarity with these rules. (3) No user shall operate or permit the operation of X-ray equipment unless the equipment and installation meet the applicable requirements of these regulations and are appropriate for the procedures to be performed. (4) Deliberate exposure of an individual to the useful beam for training or demonstration purposes shall not be permitted unless there is also a medical or dental indication for the exposure and the exposure is prescribed by a physician or dentist. (c) Areas or rooms that contain permanently installed X-ray machines as the only source of radiation shall be posted with a sign or signs CAUTION X-RAY in lieu of other signs required by the United States, title 10, Code of Federal Regulations, part 20, section 20.1902 as incorporated by reference in section 30253. (d) High radiation areas caused by radiographic and fluoroscopic machines used solely in the healing arts and which are in compliance with the access control and signal requirements of title 24, California Code of Regulations, sections 9102 through 9105 shall be exempt from the access control and signal requirements of the United States, title 10, Code of Federal Regulations, part 20, section 20.1601 as incorporated by reference in section 30253. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30306. Definitions. (a) "Automatic exposure control" means a device which automatically controls one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation. (b) "Cineradiography" means the making of a motion picture record of the successive images appearing on a fluorescent screen. (c) "Contact therapy" means irradiation of accessible lesions usually employing a very short source-skin distance and potentials of 40-50 KV. (d) "Dead-man switch" means a switch so constructed that a circuit-closing contact can only be maintained by continuous pressure by the operator. (e) "Diagnostic-type tube housing" means an X-ray tube housing so constructed that the leakage radiation measured at a distance of 1 meter from the source cannot exceed 100 milliroentgens in 1 hour when the tube is operated at its maximum continuous rate of current for the maximum rated tube potential. (f) "Filter" means material placed in the useful beam to absorb preferentially the less penetrating radiations. (g) "Interlock" means a device for precluding access to an area of radiation hazard either by preventing entry or by automatically removing the hazard. (h) "Leakage radiation" means all radiation coming from within the tube housing except the useful beam. (i) "Protective barrier" means a barrier of attenuating materials used to reduce radiation exposure. (j) "Primary protective barrier" means a barrier sufficient to attenuate the useful beam to the required degree. (k) "Scattered radiation" means radiation that, during passage through matter, has been deviated in direction. ( l "Secondary protective barrier" means a barrier sufficient to attenuate stray radiation to the required degree. (m) "Shutter" means a device, generally of lead, fixed to an X-ray tube housing to intercept the useful beam. (n) "Stray radiation" means radiation not serving any useful purpose. It includes leakage and scattered radiation. (o) "Therapeutic-type tube housing" means, (1) For X-ray therapy equipment not capable of operating at 500 kVp or above, an X-ray tube housing so constructed that the leakage radiation at a distance of 1 meter from the source does not exceed 1 roentgen in an hour when the tube is operated at its maximum rated continuous current for the maximum rated tube potential. (2) For X-ray therapy equipment capable of operating at 500 kVp or above, an X-ray tube housing so constructed that the leakage radiation at a distance of 1 meter from the source does not exceed either 1 roentgen in an hour or 0.1 percent of the useful beam dose rate at 1 meter from the source, whichever is greater, when the machine is operated at its maximum rated continuous current for the maximum rated accelerating potential. (3) In either case, small areas of reduced protection are acceptable provided the average reading over any 100 square centimeters area at 1 meter distance from the source does not exceed the values given above. (p) "Useful beam" means that part of the radiation which passes through the window, aperture, cone, or other collimating device of the tube housing. (T17- 30306-T24). Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30307. Fluoroscopic Installations (a) Equipment. (1) The tube housing shall be of diagnostic type. (2) The target-to-panel or target-to-table top distance should not be less than 18 inches and shall not be less than 12 inches. (3) The total filtration permanently in the useful beam shall not be less than 2.5 millimeters aluminum equivalent. This requirement may be assumed to have been met if the half-value layer is not less than 2.5 millimeters aluminum at normal operating voltages. (4) The equipment shall be so constructed that the entire cross-section of the useful beam is attenuated by a primary barrier. This barrier is usual ly the viewing device, either a conventional fluoroscopic screen or an image intensification mechanism. (A) The lead equivalent of the barrier of conventional fluoroscopes shall be at least 1.5 millimeters for equipment capable of operating up to 100 kVp, at least 1.8 millimeters for equipment whose maximum operating potential is greater than 100 kVp and less than 125 kVp, and at least 2.0 millimeters for equipment whose maximum operating potential is 125 kVp or greater. Special attention must be paid to the shielding of image intensifiers so that neither the useful beam nor scattered radiation from the intensifier can produce a radiation hazard to the operator or personnel. With the fluorescent screen 14 inches (35 cm) from the panel or table top, the exposure rate 2 inches 5 cm) beyond the viewing surface of the screen shall not exceed 30 mR/hr for each R per minute at the table top with the screen in the useful beam without a patient and with the fluoroscope operating at the highest potential employed. (B) Collimators shall be provided to restrict the size of the useful beam to less than the area of the barrier. For conventional fluoroscopes this requirement is met if, when the adjustable diaphragm is opened to its fullest extent, an unilluminated margin is left at all edges of the fluorescent screen with the screen centered in the beam at a distance of 35 cm (14 inches) from the panel or table top. For image intensified fluoroscopy, shutters shall be provided which can be adjusted to restrict the X-ray field to the visible portion of the image receptor during fluoroscopy. For systems employing rectangular X-ray fields and circular image receptors, this requirement is met if the collimated beam forms a square which circumscribes, and is tangent to, the circular margin of the image receptor. (C) The tube mounting and the carrier shall be so linked together that the carrier always intercepts the entire useful beam. The X-ray exposure shall automatically terminate when the carrier is removed from the useful beam. (D) Collimators and adjustable diaphragms or shutters to restrict the size of the useful beam shall provide the same degree of protection as is required of the tube housing. (5) The exposure switch shall be of the dead-man type. (6) Each fluoroscopic unit shall be equipped with a manual-reset cumulative timing device, activated by the exposure switch, which will either indicate elapsed exposure time by a signal audible to the fluorocopist or turn off the apparatus when the total exposure exceeds a predetermined limit not exceeding five minutes in one or a series of exposures. (7) Useful beam exposure rate. (A) All fluoroscopic equipment. For routine fluoroscopy, the exposure rate measured at the point where the center of the useful beam enters a typical patient shall be as low as is practicable and shall not exceed 5 roentgens per minute under the conditions specified herein. This limit shall not apply during magnification procedures or the recording of fluoroscopic images where higher exposure rates are required. Compliance with this paragraph shall be determined using the measuring specifications of Section 30307(a)(7)(D), plus the following procedures when the automatic exposure rate control is used: 1. The useful beam exposure rate shall be measured with a phantom equivalent to 9 inches of water or 7 7/8 inches of lucite, intercepting the entire useful beam. 2. If the X-ray source is below the table, the X-ray exposure rate shall be measured with the nearest part of the imaging assembly located at 14 inches above the table top. 3. The field size at the point of exposure rate measurement shall be at least 6 1/4 square inches in area in the plane perpendicular to the central ray. (B) Fluoroscopic equipment manufactured after August 1, 1974, and equipped with automatic exposure rate controls. Fluoroscopic equipment which is provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 10 roentgens per minute at the point where the center of the useful beam enters the patient, except during recording of fluoroscopicimages, or when an optional high level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute at the point where the center of the useful beam enters the patient unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed. (C) Fluoroscopic equipment manufactured after August 1, 1974, without automatic exposure rate controls. Fluoroscopic equipment which is not provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute at the point where the center of the useful beam enters the patient, except during recording of fluoroscopic images, or when an optional high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed. (D) Measuring useful beam exposure rate compliance. 1. If the X-ray tube is below the table, the exposure rate shall be measured 1 centimeter above the tabletop or cradle. 2. If the X-ray tube is above the table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. 3. In a C-arm type of fluoroscope, the exposure rate shall be measured at 30 centimeters from the input surface of the fluoroscopic imaging assembly. (8) Mobile fluoroscopic equipment shall meet the requirements of this section where applicable, except that: (A) Inherent provisions shall be made so that the machine is not operated at a source-skin distance of less than 30 cm (12 inches). (B) Image intensification shall always be provided. Conventional fluoroscopic screens shall not be used. (C) It shall be impossible to operate a machine when the collimating cone or diaphragm is not in place. (D) It shall be impossible to energize the useful beam of a mobile fluoroscope unless the entire useful beam is intercepted by the image receptor. (9) Devices which indicate the X-ray tube potential and current shall be provided, and should be located in such a manner that the operator may monitor the tube potential and current during fluoroscopy. (10) A shielding device of at least 0.25 millimeters lead equivalent shall be provided for covering the bucky-slot during fluoroscopy. (11) Whenever practicable, protective drapes, or hinged or sliding panels, of at least 0.25 millimeters lead equivalent shall be provided between the patient and the fluoroscopist to intercept scattered radiation which would otherwise reach the fluoroscopist and others near the machine. Such devices shall not substitute for wearing of a protective apron. (b) Operating Procedures. (1) Protective aprons of at least 0.25 mm lead equivalent shall be worn in the fluoroscopy room by each person, except the patient, whose body is likely to be exposed to 5 mR/hr or more. (2) On fluoroscopes with automatic exposure controls the operator shall monitor the tube current and potential at least once each week to ascertain that they are in their usual ranges for a given set of operating parameters. This requirement may be met by adjusting the controls to usual settings for fluoroscoping an average patient, and using a phantom of any suitable material with attenuation roughly equivalent to six to ten inches of water. Whenever the monitored tube current or potential vary in a way which could increase the patient X-ray exposure rate by more than 25% over the latest exposure rate measurement required by Section 30307(b)(3), the cause(s) for the change shall be determined promptly and the patient exposure rate shall be remeasured. On fluoroscopes with manual exposure control only, the operator shall monitor the tube current and potential at least once each day during use to ascertain that they are within the normal ranges used by the facility. A written log shall be kept of all monitored readings and shall include at least the tube current and potential, the date, identification of the fluoroscope, and name of the person who did the monitoring. Records of all monitored readings shall be preserved at the facility for at least three years. (3) Measurements of the table top or patient exposure rate shall be made at least once each year for units with automatic exposure control, and at least once each 3 years for units without automatic exposure control, and immediately following alteration or replacement of a major component, such as the X-ray tube, the exposure controls, the imaging assembly, and the power source. (4) On cineradiography equipment, the exposure rates to which patients are normally subjected shall be determined at least once each year, and immediately following alterations or replacement of a major component, such as the X-ray tube, the exposure controls, the imaging assembly, and the power source. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30308. Radiographic Installations (Other Than Dental and Veterinary Medicine). (a) Equipment. (1) The tube housing shall be of diagnostic type. (2) Suitable devices (diaphragms, cones, adjustable collimators), capable of restricting the useful beam to the area of clinical interest shall be provided to define the beam and shall provide the same degree of attenuation as that required of the tube housing. Such devices shall be calibrated in terms of the size of the projected useful beam at specified source-film distances. For chest photofluorographic equipment, the collimator shall restrict the beam to dimensions no greater than those of the fluorographic screen. The field size indication on adjustable collimators shall be accurate to within 2 percent of the source-film distance. The light field shall be aligned with the X-ray field with the same degree of accuracy. (3) For equipment manufactured prior to August 1, 1974, the aluminum equivalent of the total filtration in the useful beam shall be not less than that shown in Table 1: Table 1 Minimum Total Filter Operating kVp (Inherent plus added) Below 50 kVp.... 0.5 mm aluminum 50-70 kVp....... 1.5 mm aluminum Above 70 kVp.... 2.5 mm aluminum For equipment manufactured on or after August 1, 1974, the half-value layer (HVL) of the useful beam for a given X-ray tube potential shall not be less than the appropriate value specified in Table 2. Table 2 X-ray tube voltage (kilovolt peak) _____________________________________ Designed Measured Minimum HVL Operating Range Minimum HVL (mm of Al) Below 50 30 0.3 40 0.4 49 0.5 50 to 70 50 1.2 60 1.3 70 1.5 Above 70 70 2.1 80 2.3 90 2.5 100 2.7 110 3.0 120 3.2 130 3.5 140 3.8 150 4.1 (4) A device shall be provided to terminate the exposure after a pre-set time or exposure. (5) A dead-man type of exposure switch shall be provided and so arranged that it cannot be conveniently operated outside a shielded area, except that exposure switches for "spot film" devices used in conjunction with fluoroscopic tables are excepted from this shielding requirement. (6) The control panel shall include a device (usually a milliammeter) to give positive indication of the production of X-rays whenever the X-ray tube is energized. (7) The control panel shall include devices (labeled control settings and/or meters) indicating the physical factors (such as kVp, mA, exposure time, or whether timing is automatic) used for the exposure. (8) Machines equipped with beryllium window X-ray tubes shall contain keyed filter interlock switches in the tube housing and suitable indication on the control panel of the added filter in the useful beam if the total filtration permanently in the useful beam is less than 0.5 mm aluminum equivalent. The total filtration permanently in the useful beam shall be clearly indicated on the tube housing. (9) The aluminum equivalent of the table top when a cassette tray is used under the table top, or the aluminum equivalent of the front panel of the vertical cassette holder, shall not be more than 1 mm at 100 kVp. (b) Operating Procedures. (1) No individual occupationally exposed to radiation shall be permitted to hold patients during exposures except during emergencies, nor shall any individual be regularly used for this service. If the patient must be held by an individual, that individual shall be protected with appropriate shielding devices such as protective gloves and apron and he shall be so positioned that no part of his body will be struck by the useful beam. (2) Only individuals required for the radiographic procedure shall be in the radiographic room during exposure; and, except for the patient, all such persons shall be equipped with appropriate protective devices. (3) The radiographic field shall be restricted to the area of clinical interest. (4) Gonadal shielding of not less than 0.5 mm lead equivalent shall be used for patients who have not passed the reproductive age during radiographic procedures in which the gonads are in the direct beam, except for cases in which this would interfere with the diagnostic procedure. (5) The operator shall stand behind the barrier provided for his protection during radiographic exposures. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30309. Special Requirements for Mobile Radiographic Equipment. (a) Equipment. (1) All requirements of Section 30308(a) apply except 30308 (a)(5) and 30308 (a)(9). (2) The exposure control switch shall be of the dead-man type and shall be so arranged that the operator can stand at least 6 feet from the patient and well away from the useful beam. (3) Inherent provisions shall be made so that the equipment is not operated at source-skin distances of less than 12 inches. (b) Operating Procedures. (1) All provisions of Section 30308(b) apply except 30308(b)(5). (2) The target-to-skin distance shall be not less than 12 inches. (3) Personnel monitoring shall be required for all individuals operating mobile X-ray equipment. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30310. Special Requirements for Chest Photofluorographic Installations. (a) Equipment. (1) All provisions of Section 30308 (a) apply. (2) A collimator shall restrict the useful beam to the area of the photofluorographic screen. (3) The incident X-ray exposure where the central ray enters the patient shall not exceed 200 milliroentgens per radiograph for the average patient, and should not exceed 100 milliroentgens per radiograph. (b) Operating Procedures. (1) All provisions of Section 30308(b) apply. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30311. Dental Radiographic Installations. (a) Equipment. (1) The tube housing shall be of diagnostic type. (2) Diaphragms or cones shall be used for collimating the useful beam and shall provide the same degree of protection as the housing. (A) For intra-oral radiography the useful beam shall be restricted to a diameter of not more than 7 cm (2.75 inches) at the surface of the skin. (3) For intra-oral film exposures a cone or spacer frame shall provide a target-to-skin distance of not less than 18 cm (7 inches) with apparatus operating above 50 kVp or 10 cm (4 inches) with apparatus operating at 50 kVp or below. (4) The total filtration permanently in the useful beam shall be equivalent to at least 0.5 millimeters of aluminum for equipment operating below 50 kVp, equivalent to at least 1.5 millimeters of aluminum for equipment operating from 50 kVp through 70 kVp, and equivalent to at least 2.5 millimeters of aluminum for equipment operating above 70 kVp. (5) A device shall be provided to terminate the exposure after a pre-set time or exposure. (6) The exposure control switch shall be of the dead-man type. If a recycling timer is employed it shall not be possible to make a repeat exposure without release of the exposure switch to reset the timer. (7) Each installation shall be provided with a protective barrier for the operator or shall be so arranged that the operator can stand at least 6 feet from the patient and well away from the useful beam. (8) Mechanical support of the tube head and cone shall maintainthe exposure position without drift or vibration. (9) Panoramic installations. This part applies to those installations which consist of a tube head with a collimator providing a narrow useful beam and an extra oral film carrier which are interlocked in their motion about the patient. (A) All provisions of Section 30311 (a) apply except 30311 (a)(2)(A), 30311 (a)(3), 30311 (a)(10). (10) Cephalometric installations. (A) All provisions of Section 30311 (a) apply except 30311 (a)(2)(A), 30311 (a)(3), and 30311 (a)(9). (B) The radiographic field shall be restricted to the area of the image receptor. (11) The X-ray control panel shall include means for indicating X-ray tube voltage (kVp), tube current (mA), and exposure duration. The tube voltage and current shall be indicated by meters or by control settings. A milliammeter, a light or other device shall give clear and distinct visual or audible indication to the operator when X-rays are being produced. (b) Operating Procedures. (1) No individual occupationally exposed to radiation shall be permitted to hold patients or films during exposure, nor shall any individual be regularly used for this service. (2) During each exposure, the operator shall stand at least 6 feet from the patient or behind a protective barrier. (3) Only the patient shall be in the useful beam. (4) Neither the tube housing nor the position indicating device (cone, cylinder) shall be hand-held during exposure. (5) Fluoroscopy shall not be used in dental examinations. (6) Each patient undergoing dental radiography shall be draped with a protective apron of not less than 0.25 millimeter lead-equivalent to cover the gonadal area. (7) For intra-oral and cephalometric radiography the X-ray beam and the film shall be aligned very carefully with the area to be radiographed. (8) Only persons required for the radiographic procedure shall be in the radiographic room during exposures. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30312. Therapeutic X-Ray Installations. (a) Equipment. (1) The tube housing shall be of therapeutic type. (2) For equipment installed on or before August 1, 1979, permanent diaphragms or cones used for collimating the useful beam shall afford the same degree of protection as the housing. Adjustable or removable beam-defining diaphragms or cones shall transmit not more than 5 percent of the useful beam obtained at the maximum kilovoltage and with maximum treatment filter. (3) For equipment installed after August 1, 1979, permanent beam-defining devices or diaphragms shall afford the same degree of protection as the housing. Adjustable or interchangeable beam-defining devices shall transmit no more than 2 percent of the useful beam for the portion of the useful beam which is to be attenuated by the beam limiting device. Measurements shall be averaged over an area up to but not exceeding 100 square centimeters at the normal treatment distance. (4) Filters shall be secured in place to prevent them from dropping out during treatment. A filter indication system shall be used on all therapy machines using interchangeable filters. It shall indicate, from the control panel, or from the control station, the presence or absence of any filter except compensating filters, and it shall be designed to permit easy identification of the filter in place. The filter slot shall be so constructed that the radiation escaping through it does not exceed 1 roentgen per hour at 1 meter, or, if the patient is likely to be exposed to radiation escaping from the slot, 30 roentgens per hour at 5 centimeters from the external opening. Each interchangeable filter shall be marked with its thickness and material. (5) The X-ray tube shall be so mounted that it cannot turn or slide with respect to the aperture. (6) Means shall be provided to immobilize the tube housing during stationary portal treatment. (7) A suitable exposure control device such as an automatic timer, exposure meter, or dose meter shall be provided to terminate the exposure after a preset time interval or preset exposure or dose limit. A timer shall be provided to terminate the exposure after a preset time regardless of what other exposure limiting devices are present. Means shall be provided for the operator to terminate the exposure at any time. (8) Equipment utilizing shutters to control the useful beam shall have a shutter position indicator on the control. (9) An easily discernible indicator which shows whether or not X-rays are being produced shall be on the control panel. (10) Mechanical and/or electrical stops shall be provided on X-ray machines capable of operating at 150 kVp or above to insure that the useful beam is oriented only toward primary barriers. (11) When the relationship between the beam interceptor (when present) and the useful beam is not permanently fixed, mechanical or electrical stops shall be provided to insure that the beam is oriented only toward primary barriers. (b) Operating Procedures. (1) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used. (2) No patient other than the one being treated shall be in the treatment room during exposure. (3) No person other than the patient shall be in the treatment room when the tube is operated at potentials exceeding 150 kVp. At operating potentials of 150 kVp or below, persons other than the patient and operator may be in the treatment room for good reason but only if they are adequately protected and their radiation exposure is appropriately monitored. (4) A calibration of the output of each radiation therapy system shall be performed before the system is first used for irradiation of a patient, and thereafter at intervals not to exceed 24 months. Therapy equipment shall not be used for any therapy treatments except at those combinations of effective energy, field size, and treatment distance for which the equipment has been calibrated. The calibration shall be performed by or under the direct supervision of a person who has been determined by the Department to have adequate training, experience and knowledge in radiation therapy physics, and who shall be present at the facility during such calibration. After any change which might significantly alter the output, spatial distribution, or other characteristics of the therapy beam, the parameters which might be affected shall be measured. (A) For therapy systems operating at potentials above 500 kVp, the determinations included in the calibration shall be provided in sufficient detail so that the absorbed dose in tissue in the useful beam may be calculated to within 5 percent. The calibration shall include, but shall not be limited to, the following determinations: 1. Verification that the equipment is operating in compliance with the design specifications concerning the light localizer, the side light and back-pointer alignment with the isocenter when these specifications are known and applicable, variation in the axis of rotation for the table, gantry and jaw system, and beam flatness and symmetry at specified depths. 2. The relative dose at various depths in a tissue equivalent phantom for each effective energy and the ranges of field sizes and treatment distances used for radiation therapy. 3. The congruence between the radiation field and the field indicated by the localizing device. 4. The uniformity of the radiation field and its dependency upon the direction of the useful beam. 5. The absolute dose per unit time and dose per monitor setting. (B) For therapy systems operating at potentials between 150 kVp and 500 kVp inclusive, the calibration shall include, but shall not be limited to, the following determinations: 1. The exposure rates and/or dose rates for each combination of field size, technique factors, filter, and treatment distance used. 2. The degree of congruence between the radiation field and the field indicated by the localizing device if such device is present. 3. An evaluation of the uniformity of the radiation field symmetry for the field sizes used, and any dependence upon tube housing assembly orientation. (5) All new installations and existing installations not previously surveyed shall have a radiation protection survey performed by or under the direction of a person determined by the Department to have adequate knowledge and training to advise regarding radiation protection needs, to measure ionizing radiation and to evaluate safety techniques. If the survey shows that supplementary shielding is required a resurvey shall be performed after its installation. In addition, a resurvey shall be made after every change which might decrease radiation protection significantly. The surveyor shall report his findings in writing to the user. The report shall indicate whether or not the installation is in compliance with all applicable radiation protection requirements of this section. The user shall report the findings of the survey in writing to the Department within 15 days of his receipt of the survey report. (6) The exposure rate or dose rate of the useful beam and the size and shape of the useful beam shall be known with reasonable certainty at all times during operation of the radiation therapy apparatus for medical purposes. (7) Spot checks shall be performed at least once each week for therapy systems operating at potentials above 500 kVp, and at least once each month for therapy systems operating at 500 kVp or below. (A) The measurements taken during spot checks shall demonstrate the degree of consistency of the operating characteristics which can affect the radiation output of the system or the radiation delivered to a patient during a therapy procedure. (B) For systems in which the calibrating person believes beam quality can vary significantly, spot checks shall include beam quality checks. (C) The spot check procedures shall be in writing and shall have been developed or approved by the individual who made the most recent calibration of the system pursuant to Section 30312(b)(4). The written spot check procedures shall specify when measurements and determinations indicate an inconsistency or potential change in radiation output. When more than the minimum frequency of spot checking is necessary, the spot check procedures shall specify the frequency at which spot checks are to be performed. (D) When spot check results are erratic or inconsistent with calibration data, the person who designed the spot check procedures, or a person of equivalent competence, shall be consulted immediately and the reason(s) for the inconsistency corrected before the system is used for patient irradiation. (8) Calibration of the therapy beam shall be performed with a measurement instrument which has been calibrated within the preceding two years directly, or through no more than one exchange, at the National Institute of Standards and Technology, or facility determined acceptable by the Department. In addition, indirect spot checks or intercomparisons of measurement instruments with secondary standards shall be made at least each six months. (9) Reports of each radiation safety survey spot check and calibration performed pursuant to this section shall be maintained at the facility for at least three years. A copy of the treatment data developed from the latest calibration shall be available for use by the operator at the treatment control station. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30313. Special Requirements for X-Ray Therapy Equipment Operated at Potentials of 50 kV and Below. (a) Equipment. (1) All provisions of Section 30312(a) apply. (2) A therapeutic-type protective tube housing shall be used. Contact therapy machines shall meet the additional requirement that the leakage radiation at 2 inches from the surface of the housing not exceed 0.1 R/hr. (3) Automatic timers shall be provided which will permit accurate presetting and determination of exposures as short as one second. (b) Operating Procedures. (1) All provisions of Section 30312(b) apply except 30312(b)(1) and 30312(b)(7). (2) In the therapeutic application of apparatus constructed with beryllium or other low-filtration windows adequate shielding shall be required to protect against unnecessary exposure from the useful beam, and special safeguards are essential to avoid accidental exposures to the useful beam. There shall be on the control panel some easily discernible device which will give positive information as to whether or not the tube is energized. (3) Machines having an output of more than 1,000 roentgens per minute at any accessible place shall not be left unattended without the power being shut off at the primary disconnecting source. (4) If the X-ray tube of a contact therapy machine is hand-held during irradiation, the operator shall wear protective gloves and apron. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30314. Veterinary Medicine Radiographic Installations. (a) Equipment. (1) The tube housing shall be of diagnostic type. (2) Diaphragms or cones shall be provided for collimating the useful beam to the area of clinical interest and shall provide the same degree of protection as is required of the housing. (3) The total filtration permanently in the useful beam shall not be less than 1.5 millimeters aluminum-equivalent for equipment operating up to 70 kvp and 2.0 millimeters aluminum-equivalent for machines operated in excess of 70 kvp. (4) A device shall be provided to terminate the exposure after a pre-set time or exposure. (5) A dead-man type of exposure switch shall be provided, together with an electrical cord of sufficient length so that the operator can stand out of the useful beam and at least 6 feet from the animal during all X-ray exposures. (b) Operating Procedures. (1) The operator shall stand well away from the tube housing and the animal during radiographic exposures. The operator shall not stand in the useful beam. If film must be held, it shall be held by individuals not occupationally exposed to radiation. Hand-held fluoroscopic screens shall not be used. The tube housing shall not be held by the operator. No individuals other than the operator shall be in the X-ray room while exposures are being made unless such person's assistance is required. (2) In any application in which the operator is not located behind a protective barrier, clothing consisting of a protective apron having a lead-equivalent of not less than 0.25 millimeter shall be worn by the operator and any other individuals in the room during exposures. (3) No individual shall be regularly employed to hold or support animals during radiation exposures. Operating personnel shall not perform this service except very infrequently and then only in cases in which no other method is available. Any individual holding or supporting an animal during radiation exposure shall wear protective gloves and apron having a lead-equivalent of not less than 0.25 millimeter. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code. s 30315.10. Definitions. (a) The definitions in section 30100 shall apply to this article. (b) As used in this article: (1) "Action limit" means the minimum or maximum value of a quality assurance measurement representing acceptable performance. (2) "Activities" means the operation of a mammography system to produce the mammogram, the initial interpretation of the mammogram, and the maintenance of the viewing conditions for that interpretation. (3) "Adverse event" means an undesirable experience associated with mammography activities such as: (A) Poor image quality; (B) Failure to send mammography reports within 30 calendar days from the date of the mammographic examination to the referring physician or to the patient; and (C) Use of personnel that do not meet the applicable requirements of sections 30315.50, 30315.51 or 30315.52. (4) "Air kerma" means the kerma, measured in Gray (Gy), in a given mass of air. (5) "Automatic exposure control" (AEC) means a device that automatically controls one or more technique factors in order to obtain at pre-selected locations a required quantity of radiation. (6) "Average glandular dose" means the value in millirad (mrad) or milligray (mGy) for a given breast or phantom thickness that estimates the average absorbed dose to the glandular tissue extrapolated from free air exposures and based on fixed filter thickness and target material. (7) "Category I" means medical educational activities that have been designated as Category I by the Accreditation Council for Continuing Medical Education, the American Osteopathic Association, or a state medical society. (8) "Clinical image review" means the process whereby the mammograms produced by a specific mammography system are evaluated for image quality. (9) "Consumer" means an individual who chooses to comment on or complain in reference to a mammographic examination, including the patient or representative of the patient, such as a family member or referring physician. (10) "Continuing education unit" means one hour of training received through either: (A) Face-to-face interaction between instructor(s) and student(s), as when the instructor provides a lecture, conducts demonstrations, or reviews student performance; or (B) The administration and correction of student examinations by an instructor(s) with subsequent feedback to the student(s). (11) "Direct supervision" means the oversight of operations that include the following: (A) During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised and signs the resulting report before it is entered into the patient's record. (B) During performance of a mammographic examination, the supervising mammographic radiologic technologist is physically present to observe, and correct, as needed, the performance of the individual who is performing the mammographic examination. (C) During performance of a survey, the supervising medical physicist is physically present to observe, and correct, as needed, the performance of the individual who is performing the survey. (12) "Established operating level" means the value of a particular quality assurance parameter that has been established as an acceptable normal level by the facility's quality assurance program. (13) "Facility" means a hospital, outpatient department, clinic, radiology practice, an office of a physician, mobile setting, or other place or building in which a person conducts: (A) Mammography activities; and/or (B) Interventional mammography or research mammography. (14) "Facility accreditation certificate" means a document issued by the Department authorizing a facility to perform mammography. (15) "FDA" means the United States Food and Drug Administration. (16) "Image receptor" means any device that transforms incident X-ray photons either into a visible image or into another form that can be made into a visible image by further transformations. (17) "Interpreting physician" means a licensed physician who interprets mammograms and meets the requirements of section 30315.50. (18) "Interim Facility Accreditation Certificate" means a document issued by the Department pursuant to section 30315.24. (19) "Interventional mammography" means the creation of a mammogram during invasive interventions for localization, biopsy procedures, or therapeutic procedures. (20) "Kerma" means the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass. (21) "Lead interpreting physician" means the interpreting physician designated either by the person who owns or leases the facility, or an authorized agent of that person to ensure that the facility's quality assurance program meets all of the requirements of this article. (22) "Mammogram" means an X-ray image of the human breast. (23) "Mammographic examination" means the performance of mammography on a human being. (24) "Mammographic modality" means a technology for radiography of the breast such as screen-film mammography, digital mammography and xeromammography. (25) "Mammography" means the procedure for creating a mammogram. (26) "Mammography medical outcomes audit" means a systematic collection of mammography results and the comparison of those results with outcome data. (27) "Mammography system" means a system that includes all of the following: (A) A radiation machine used as a source of radiation to produce a mammogram; (B) An imaging receptor used for the formation of a latent image of a mammogram or for converting X-ray photons to a digital signal; (C) A processing device for changing a latent image of a mammogram or a digital signal to a visual image that can be used for diagnostic or therapeutic purposes; and (D) A viewing device, such as a view box or computer monitor, used to visually evaluate a mammogram. (28) "Mammography system evaluation" means an evaluation of the mammography system by a medical physicist to ensure the system is in compliance with sections 30316 and 30316.20(e). (29) "Medical physicist" means an individual trained in performing mammography system evaluations, quality assurance testing evaluations and surveys. (30) "Mobile service provider" means a person who performs mammography in a mobile setting. (31) "Mobile setting" means a setting in which mammography is performed with a radiation machine that is fixed or used exclusively in a mobile vehicle or unit, or is transported to a different location for the purpose of providing mammography, but does not include a radiation machine moved from room to room within a facility. (32) "Multi-reading" means two or more physicians interpreting the same mammogram, at least one of whom meets the requirements of section 30315.50. (33) "Overall assessment of findings" means the results of an interpreting physician's evaluation of mammograms produced during a mammographic examination and categorized using the assessment categories specified in section 30317.40(a)(4). (34) "Phantom" means a test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer. (35) "Phantom image" means a radiographic image of a phantom. (36) "Physical science" means physics, chemistry, radiation science (including medical physics and health physics), and engineering. (37) "Positive mammogram" means a mammogram that has an overall assessment of findings that are either "suspicious" or "highly suggestive of malignancy." (38) "Quality assurance technologist" means an individual who meets the requirements of section 30315.51 and has experience performing or assisting in the performance of quality assurance tests specified in section 30316.20(a) through (d) and (f) (39) "Quality assurance testing evaluation" means an evaluation of a facility's quality assurance testing by a medical physicist to ensure quality assurance testing is performed in accordance with section 30316.20 excluding subsection (e) of section 30316.20. (40) "Research mammography" means the creation of a mammogram with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations in part 812 of title 21, Code of Federal Regulations. (41) "Serious adverse event" means an adverse event that may significantly compromise clinical outcomes, or an adverse event for which appropriate corrective action was not taken in a timely manner. (42) "Serious complaint" means a report of a serious adverse event. (43) "Source-to-image receptor distance" (SID) means the distance from the X-ray source to the center of the input surface of the image receptor. (44) "Standard breast" means a 4.2 cm thick compressed breast consisting of 50 percent glandular and 50 percent adipose tissue. (45) "Survey," in lieu of the definition found in title 10, Code of Federal Regulations, section 20.1001 incorporated by reference in section 30253, means the on-site performance of a mammography system evaluation and a quality assurance testing evaluation by a medical physicist. (46) "Traceable to a national standard" means that the instrument used to quantitatively measure radiation has been calibrated at: (A) The National Institute of Standards and Technology (NIST); or (B) A calibration laboratory that participates in a proficiency program with NIST at least once every two years during which the calibration laboratory achieves agreement within plus or minus 3.0 percent of the NIST standard at mammography energy levels. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30315.20. Facility Accreditation Certificate and Interim Facility Accreditation Certificate. (a) Except for persons only performing interventional mammography or research mammography, a person shall not perform mammography activities unless performed in a facility that: (1) Possesses a current and valid Facility Accreditation Certificate or an Interim Facility Accreditation Certificate; and (2) Meets the requirements of this subchapter. (b) An Interim Facility Accreditation Certificate shall be valid for six months beginning on the date of issuance. (c) A Facility Accreditation Certificate shall be valid for three years beginning on the date of issuance. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30315.22. Eligibility for a Facility Accreditation Certificate. (a) To be eligible for a Facility Accreditation Certificate a facility shall: (1) Submit the application described in section 30315.33; (2) Comply with section 30108; (3) Pass a Department inspection verifying that: (A) Physicians interpreting mammograms meet the requirements of section 30315.50; (B) Mammographic radiologic technologists meet the requirements of section 30315.51; (C) Medical physicists meet the requirements of section 30315.52; (D) Mammography systems meet the requirements of section 30316; (E) The mammography quality assurance program is capable of meeting the requirements of section 30317.10; (F) By following the procedure specified in section 30316.20(b), phantom images of a phantom that meets the requirements of section 30316.22 produced by all mammography systems, meet the criteria specified in section 30316.20(b)(1) through (3); (G) By use of the facility's proposed technique factors for a standard breast, the average glandular dose for each radiation machine used for mammography does not exceed the value specified in section 30316.20(e)(10); (H) The quality assurance manual meets the requirements of section 30317.20; (I) The mammography procedures manual meets the requirements of section 30317.30; (J) The facility is capable of ensuring mammograms and mammographic examination reports meet the requirements of sections 30316.50 and 30317.40; (K) The facility is capable of conducting a mammography medical outcomes audit that meets the requirements of section 30317.60; (L) The facility has a consumer complaint procedure that meets the requirements of section 30317.70; and (M) The requirements of Group 3 of this regulation are met. (4) After receipt of an interim facility accreditation certificate issued pursuant to section 30315.24, for each machine that will be used to perform mammography, pass a clinical image review conducted by the Department pursuant to section 30315.35, or conducted by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A); and (5) After receipt of an interim facility accreditation certificate issued pursuant to section 30315.24, possess a current and valid certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(b). Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30315.23. Renewal of a Facility Accreditation Certificate. (a) To renew a Facility Accreditation Certificate, a facility shall: (1) Seven months prior to the expiration date of the facility accreditation certificate submit the facility application described in section 30315.33; (2) For each radiation machine that will be used for mammography, either: (A) Pass a clinical image review conducted by the Department pursuant to section 30315.35(c) prior to the expiration date of the current facility accreditation certificate; or (B) Have the machine's accreditation renewed by an entity approved by FDA pursuant to 42 United States Code Section 263b(e)(1)(A); and (3) Possess a current and valid certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(b). Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30315.24. Interim Facility Accreditation Certificate. An interim facility accreditation certificate shall not be issued until a facility has complied with section 30315.22(a)(1) through (3) and has obtained a provisional certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(b)(2). Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30315.33. Complete Facility Application. (a) An application submitted for compliance with sections 30315.22 or 30315.23 shall be considered complete if the application contains the following: (1) The legal name of the applicant, the mailing address, and the telephone number; (2) The name under which the applicant's facility does business and, if doing business under a fictitious name, a copy of the applicant's fictitious name permit; (3) The name of the contact person for the facility; (4) The facility location address and mailing address if different from location address. (5) The registration number issued by the Department pursuant to section 30108 and the expiration date of registration; (6) The applicant's federal employer identification number and California taxpayer identification number; (7) If the facility is accredited by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A), the name of that entity. (8) If the applicant requests approval to perform mammography in a mobile setting: (A) The physical address of each location where mammography will be performed; (B) For each location where mammography will be performed, the name and telephone number of the responsible person who is allowing the service to be provided at the location; (C) Whether the mammograms will be processed with an on-board processor or at specific locations. If the facility will process mammograms at specific locations, the physical address of each location where mammograms will be processed; (D) Whether the radiation machine is fixed or used, exclusively, in a mobile vehicle or is transported to the use location and moved to where mammographic examinations will be performed. If the radiation machine is moved to where mammographic examinations will be performed, the designated room number within the physical building at each location of use; and (E) A description of the quality assurance tests that will be performed each time the radiation machine is relocated. (9) Responses to the following questions: (A) "Have you ever performed mammography authorized pursuant to a certificate issued by FDA?" If the answer is yes, provide in your response the names under which mammography was performed; (B) "If you have been certified by FDA to perform mammography, has that certificate ever been revoked or suspended, or has FDA ever denied to renew that certificate?" If the answer is yes, provide in your response the following: 1. The identity of any specific radiation machine(s) that failed to pass clinical image review; 2. The dates of failure; 3. The actions taken to correct any clinical image review deficiencies including physician or technologist training, radiation machine or processor repair and acquisition of replacement equipment or image receptors; 4. Whether the radiation machine passed the clinical image review subsequent to actions taken as identified in subsection (a)(9)(B)3 and when; 5. If, within the three years prior to the date of application, any radiation machine used for mammography identified in subsection (a)(15) failed clinical image review during a time when accredited by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A), copies of the failure reports; and 6. If accreditation issued by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A), was suspended or revoked, a description of the circumstances that led to suspension or revocation. (C) "Is any interpreting physician you seek to allow to interpret mammograms currently under a Department-directed plan of corrective action for interpretation done at some other facility?" If the answer is yes, provide in your response the following: 1. The name and medical license number of the interpreting physician; and 2. The facility's name and registration number where the interpreting physician was required to complete a directed plan of corrective action. (10) The name of the individual designated as the lead interpreting physician. (11) The name, medical license number, certificate number and expiration date as shown on the individuals certificate issued pursuant sections 30466(d) or 30467 of each physician who will interpret mammograms produced by the facility; (12) The name, certificate number and expiration date of certification shown on the certificate issued pursuant to section 30455.1 for each mammographic radiologic technologist who will perform mammographic examinations for the facility; (13) The name of each medical physicist who will perform the tests specified in section 30316.20(e) for the facility; (14) The name of the quality assurance technologist; (15) For each radiation machine that will be used to perform mammographic examinations: (A) The machine's manufacturer, model number, and serial number of the control; (B) Whether the machine will be used in a mobile setting. If the machine will not be used in a mobile setting, the designated room number within the facility where the machine is installed or fixed; (C) Whether the machine is a screen-film, xeromammography or digital system. If the machine is a screen-film system, the name of the manufacturer of the screen and film, and the type of screen and film used; and (D) If the machine requires a screen-film image receptor, a phantom image of a phantom that meets the requirements of section 30316.22. (16) A copy of the report indicating the results of a mammography system evaluation performed less than 6 months prior to the date of the application by a medical physicist or in lieu thereof for renewal applications, a copy of the report indicating the results of a survey performed less than 12 months prior to the date of the renewal application by a medical physicist and if the mammography system evaluation report or the survey report identifies deficiencies or recommendations for improvements in facility operations: (A) A list and description of corrective actions taken and the date corrections were achieved; (B) Copies of work invoices; (C) Documentation that those corrective actions were taken and those actions corrected the deficiencies or that those recommendations were followed. (17) For each film processor that is used to process mammograms: (A) The make and model number; and (B) Whether the processor uses extended processing or standard processing. (18) If this is a renewal application, the number of the following procedures performed in the previous year: (A) Screening procedures; (B) Diagnostic procedures; (C) The total number of screening and diagnostic procedures; (D) Biopsy procedures; (E) Needle localization procedures; and (F) Therapeutic procedures. (19) If this is a renewal application, the identification number and expiration date shown on the FDA certificate issued to the applicant's facility; (20) Whether the applicant participates or intends to participate in either the Breast Cancer Early Detection Program or the Breast and Cervical Cancer Control Program of the Department or any of their successors; (21) If the applicant is a Medi-Cal provider, the nine-digit Medi-Cal number used to bill for mammographic examinations performed at the facility's location; (22) If the applicant is a Medicare provider, the nine-digit Medicare number used to bill for mammographic examinations performed at the facility's location; (23) Name, title, signature and date of signature of the applicant and lead interpreting physician. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30315.34. Application Processing Times. (a) Within 30 calendar days of receipt of an application for or renewal of a facility accreditation certificate, the Department shall: (1) Notify the applicant that the application is complete; or (2) Notify the applicant that the application is incomplete and identify what is required for the Department to consider it complete. (b) Unless the applicant responds to the notification in subsection (a)(2) within 30 calendar days the application shall be deemed withdrawn and the applicant may reapply by submitting a new application. (c) Within six months of receipt of a complete application, the Department shall issue or deny the facility accreditation certificate. (d) The Department's time periods for processing an application for or renewal of a facility accreditation certificate from receipt of the initial application to the date the final decision is made, are as follows: (1) The median time is five and one-half months; (2) The minimum time is four months; (3) The maximum time is 12 months. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 15376, Government Code. s 30315.35. Clinical Image Review. (a) After receipt of an interim facility accreditation certificate issued pursuant to section 30315.24, applicants for a facility accreditation certificate shall: (1) Select mammograms in accordance with the criteria specified in title 21, Code of Federal Regulations, section 900.4(c)(4); and (2) Within 75 calendar days of the date of issuance as shown on the interim facility accreditation certificate, submit those mammograms for clinical image review. (b) If the mammograms fail the review, additional mammograms may be submitted if the resubmission is made no less than 75 calendar days prior to the expiration date of the interim facility accreditation certificate. (c) Applicants for renewal of a facility accreditation certificate shall: (1) Select mammograms in accordance with the criteria specified in title 21, Code of Federal Regulations, section 900.4(c)(4); and (2) Submit those mammograms for clinical image review no less than 75 calendar days prior to the expiration date of the facility accreditation certificate. (d) Mammograms submitted pursuant to this section shall meet the FDA-accepted attributes as specified in title 21, Code of Federal Regulations, section 900.4(c)(2). Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30315.36. Mammography Review. (a) Each facility possessing a facility accreditation certificate shall, upon request, make mammograms and reports specified in section 30317.40(a) available to the Department and allow those mammograms and reports to be removed from the facility for the purpose of evaluating mammogram image quality. (b) For sample sizes of two mammographic examinations: (1) If one mammographic examination fails the review, the facility shall submit a plan of corrective action, acceptable to the Department, addressing those areas that resulted in the failure and satisfactorily complete that plan; or (2) If both mammographic examinations fail the review, the facility shall satisfactorily complete a plan of corrective action as directed by the Department addressing those areas of the review that resulted in the failure. The facility shall be subject to additional review using a larger sample. (c) For sample sizes greater than two mammographic examinations: (1) If 20 percent of the mammographic examinations fail the review, the facility shall submit a plan of corrective action, acceptable to the Department, addressing those areas that resulted in the failure and satisfactorily complete that plan; (2) If 40 percent of the mammographic examinations fail the review, the facility shall satisfactorily complete a plan of corrective action as directed by the Department addressing those areas of the review that resulted in the failure; or (3) If 80 percent or more of the mammographic examinations fail the review, the facility shall cease the performance of mammography and submit to additional review and: (A) If 70 percent or more of the mammographic examinations pass this additional review, the facility may restart the performance of mammography after satisfactorily completing a plan of corrective action as directed by the Department and shall, within 75 calendar days of notification that the mammograms passed the review, submit mammograms in accordance with section 30315.35(a)(1); or (B) If less than 70 percent of the mammographic examinations pass this additional review, the facility shall not restart the performance of mammography and shall notify every patient who had a mammogram at the facility during the two-year period preceding the date of failure. The notification shall be approved by the Department prior to mailing and include: 1. The name of the patient; 2. The date the patient's mammogram was performed; 3. The statement, "The Department of Health Services of the State of California has conducted a review of the mammograms produced by (the name of the facility) and has determined that the mammograms do not meet the standards set by the Department. Therefore, we strongly advise you to consult with your physician as soon as possible regarding a repeat mammographic examination." (d) Mammograms reviewed pursuant to this section shall meet the FDA-accepted attributes as specified in title 21, Code of Federal Regulations, section 900.4(c)(2). Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30315.50. Interpreting Physician Requirements. (a) An interpreting physician for a facility shall: (1) Possess a current and valid radiology supervisor and operator certificate issued pursuant to sections 30467 or 30466(d); and (2) Meet the requirements specified in title 21, Code of Federal Regulations, section 900.12(a)(1). Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30315.51. Personnel Requirements for Individuals Who Perform Mammography. (a) Mammographic examinations shall not be performed unless the individual who performs the mammographic examination: (1) Possesses a current and valid mammographic radiologic technology certificate issued pursuant to section 30455.1; and (2) Meets the requirements specified in title 21, Code of Federal Regulations, section 900.12(a)(2). Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 115115, Health and Safety Code. s 30315.52. Medical Physicist Requirements. (a) A medical physicist for a facility shall: (1) Be authorized by the Department pursuant to section 30315.60; (2) Have a masters degree or higher in a physical science from an accredited institution, with no less than 20 semester hours or 30 quarter hours of college undergraduate or graduate level physics; (3) Complete 20 hours of documented specialized training in conducting surveys of mammography facilities; and (4) Conduct a survey of at least one mammography facility and a total of at least ten mammography radiation machines under the direct supervision of a medical physicist who has already met the requirements of this section, but in no case may more than one survey of a specific radiation machine conducted within a period of 60 calendar days be counted towards the total number of radiation machines surveyed. The period of time spent in meeting the survey requirement may be counted toward meeting the 20-hour training requirement in subsection (a)(3). After April 28, 1999, experience conducting surveys shall be acquired under the direct supervision of a medical physicist who meets the requirements of subsections (a)(1) through (4) and (b); or (5) In lieu of subsections (a)(2) through (4), qualify as a medical physicist under Title 21, Code of Federal Regulations, section 900.12(a)(3), as published in the December 21, 1993 Federal Register (58 Fed.Reg. 67571) and have retained that qualification by maintenance of the active status of any licensure, approval, or certification required under those regulations and prior to April 28, 1999: (A) Received a bachelor's degree or higher in a physical science from an accredited institution with no less than 10 semester hours or equivalent of college undergraduate or graduate level physics; (B) After meeting the requirements of subsection (a)(5)(A), completed forty hours of documented specialized training in conducting surveys of mammography facilities; and (C) After meeting the requirements of subsection (a)(5)(A), conducted surveys of at least one mammography facility and a total of at least 20 mammography radiation machines but in no case may more than one survey of a specific radiation machine conducted within a period of 60 calendar days be counted towards the total radiation machine survey requirement. The period of time spent in meeting the survey requirement may be counted toward meeting the 40- hour training requirement in subsection (a)(5)(B). (b) A medical physicist for a facility shall meet the requirements specified in title 21, Code of Federal Regulations, section 900.12(a)(3)(iii) and (iv). Note: Authority cited: Sections 100275, 115060 and 115100, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30315.60. Authorization and Renewal of Authorization to Conduct Mammography Surveys, Revocation and Suspension of Authorization and Application Processing Times. (a) To be eligible for authorization to conduct mammography surveys an individual shall submit a complete application consisting of the following: (1) Name, social security number (pursuant to the authority found in sections 100275 and 115100 of the Health and Safety Code and as required by section 17520 of the Family Code, providing the social security number is mandatory. The social security number will be used for purposes of identification), mailing address, daytime telephone number, and FAX number; (2) Documentation that the applicant meets the requirements of: (A) Sections 30315.52(a)(2) through (4); or (B) Section 30315.52(a)(5). (3) Documentation that the applicant meets the requirements of section 30315.52(b); (4) Three sample survey reports, meeting the requirements of section 30316.60, indicating the name of the medical physicist providing direct supervision and that the applicant performed all tests. Each report shall include language and data that establishes that all tests were performed to determine if the facility meets the requirements of this article and that, if a test method is specified, the test method was followed; and (5) The following information: (A) Manufacturer, model and serial number of the phantom used to produce phantom images; (B) Whether the type of system resolution tool used to evaluate system resolution is a bar pattern or, until October 28, 2002, a star pattern; (C) Method used to evaluate kVp; (D) Method used to evaluate compression; (E) Type of instruments used to determine average glandular dose and a copy of the most recent calibration report for that instrument indicating that it complies with section 30316.61; (F) Whether aluminum filters used to determine the radiation machine's half-value layer of the useful beam is type 1100 or type 1145; (G) Manufacturer, model and serial number of the densitometer, sensitometer and photometer used during surveys; and (H) A list of equipment used to evaluate the mammography system for artifacts and the radiation machine's AEC performance; or (6) In lieu of subsections (a)(2) and (3), a copy of the letter issued to the applicant by FDA stating that the applicant met the requirements of title 21, Code of Federal Regulations, section 900.12(a)(3). (b) Individuals approved by use of subsection (a)(2)(B) shall not provide direct supervision. (c) Surveys of radiation machines used to perform interventional mammography or research mammography shall not be used to comply with this section. (d) Authorization shall be valid for three years. (e) To be eligible for renewal of authorization to conduct mammography surveys an individual shall submit a complete application consisting of the following: (1) Name, social security number (pursuant to the authority found in sections 100275 and 115100 of the Health and Safety Code and as required by section 17520 of the Family Code, providing the social security number is mandatory. The social security number will be used for purposes of identification), mailing address, daytime telephone number, and FAX number; (2) The following information: (A) If changes to the information submitted pursuant to subsection (a)(5) have occurred, the updated information; (B) A copy of the most recent calibration report for the instrument used to determine average glandular dose. (3) Documentation indicating that at least 8 hours of training in surveying radiation machines were received for each new mammographic modality; and (4) Documentation that the applicant meets the requirements of section 30315.52(b). (f) Authorization to conduct mammography surveys may be revoked, suspended, amended or restricted for any of the following: (1) Failure to comply with section 30315.52(b); (2) Knowingly conduct or perform mammography system evaluations, quality assurance testing evaluations or surveys that cause or would have caused, if not detected, a facility to be in violation of any provision of the Act, any regulation promulgated pursuant to the Act, any provision of the Radiologic Technology Act, as defined in Health and Safety Code section 27, any regulation promulgated pursuant to the Radiologic Technology Act, or any order of the Department; (3) Knowingly submits to the Department false, incorrect or fraudulent information; (4) Failure to inform a facility that a violation of this article has occurred when the medical physicist knows of the violation; or (5) Procuring authorization by fraud, or misrepresentation, or because of mistake. (g) Within 10 calendar days of receipt of an application for or renewal of authorization, the Department shall: (1) Notify the applicant that the application is complete; or (2) Notify the applicant that the application is incomplete and identify what is required for the Department to consider it complete. (h) Unless the applicant responds to the notification in subsection (g)(2) within 30 calendar days the application shall be deemed withdrawn. (i) Within 30 calendar days of receipt of a complete application, the Department shall issue or deny the authorization. (j) Any applicant deemed by the Department to have withdrawn an application pursuant to subsection (e) may reapply by submitting a new application. (k) The Department's time periods for processing an application for authorization from receipt of the initial application to the date the final decision is made, are as follows: (1) The median time is 30 calendar days; (2) The minimum time is seven days; (3) The maximum time is 90 calendar days. Note: Authority cited: Sections 100275, 115060 and 115100, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code; and Section 15376, Government Code. s 30316. Mammography System Requirements. (a) A radiation machine designed for general purpose radiography, or special nonmammography procedures or that has been modified or equipped with special attachments for mammography shall not be used for mammography. (b) Radiation machines used for mammography shall: (1) Be specifically designed and manufactured for mammography and meet the requirements of section 30305(a)(4). (2) Provide a tube-image receptor assembly that is capable of being fixed in any operating position where it is designed to operate and once fixed in any such position, does not undergo unintended motion and does not fail in the event of power interruption. (3) If equipped with screen-film image receptors: (A) Be able to be operated with image receptors of 18 x 24 centimeters (cm) and 24 x 30 cm; (B) Have moving grids matched to all image receptor sizes provided; and (C) Be able to be operated with the grid removed, if the system is used for magnification procedures; (4) If used to perform noninterventional problem solving procedures, have a radiographic magnification capability with at least one magnification value within the range of 1.4 to 2.0. (5) When equipped with more than one focal spot, indicate, prior to exposure, which focal spot has been selected. (6) When equipped with more than one target material, indicate, prior to exposure, the preselected target material. (7) When equipped such that the target material and/or focal spot are selected by a system algorithm that is based on the exposure or on a test exposure, display, after the exposure, the target material and/or focal spot actually used during the exposure. (8) Incorporate a compression device that: (A) Effective October 28, 2002, provides: 1. An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and 2. Fine adjustment compression controls operable from both sides of the patient. (B) Provides different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for "spot compression") may be provided but shall be exempt from the requirements of subsection (b)(8)(C); and (C) Except as provided in subsection (b)(8)(D), provides a compression paddle that is flat and parallel to the image receptor holder assembly and does not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied. The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor. The chest wall edge shall not appear on the image; (D) If the compression paddle is intended by the manufacturer's design to not be flat and parallel to the image receptor holder assembly during compression, the paddle shall meet the manufacturer's design specifications and maintenance requirements; and (E) If the chest wall edge is bent upward for patient comfort, the edge shall not appear on the image. (9) Provide manual selection of milliampere-seconds (mAs) or milliamperes (mA) and time, and; (10) Indicate kVp, mA and time and/or mAs before the exposure begins, or when AEC is used, the technique factors that are set prior to the exposure; (11) When the AEC mode is used, indicate the actual technique factors (kVp and mAs or mA and time) used, after completion of the exposure; (12) If it is a screen-film system, provide an AEC mode that is operable in all combinations of equipment configuration provided on that unit, such as grid, nongrid, magnification, nonmagnification and various target-filter combinations, and: (A) Provides a positioning or selection of the detector that is flexible in the placement of the detector under the target tissue; (B) Clearly indicates the size and available positions of the detector at the X-ray input surface of the compression paddle; (C) Clearly indicates the selected position of the detector; and (D) Provides a means to vary the selected optical density from the normal or baseline setting. (13) If equipped with a light beam that passes through the X-ray beam-limiting device, the light provides an average illumination of 160 lux (15 foot candles) at the lesser of: (A) 100 centimeters; or (B) The maximum source-to-image-distance the machine can obtain. (c) A facility shall not perform mammography using a screen-film mammography system unless: (1) There are at least four image receptors of 18 x 24 centimeters (cm) and at least four image receptors of 24 x 30 cm available for use by the person performing mammographic examinations; (2) The X-ray film and intensifying-screens are designated by the film manufacturer and the screen manufacturer as appropriate for mammography and the X-ray film matches the screen's spectral output as specified by the screen manufacturer; (3) Chemical solutions used for processing mammograms are capable of developing the film so as to meet the minimum requirements specified by the film manufacturer; (4) Special lights for film illumination, or hot lights, that are capable of producing light levels greater than that provided by the view box are available; and (5) Film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available to all physicians interpreting mammograms for the facility. (d) Documentation demonstrating compliance with this section shall be maintained in accordance with section 30319.20. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30316.10. Evaluations of New, Replaced or Repaired Equipment. (a) Whenever the following occur, the affected equipment shall meet the requirements specified in sections 30316 and 30316.20 before the affected equipment is used to produce or process mammograms: (1) Installation of a new radiation machine or processor; (2) Disassembly and reassembling of a radiation machine or processor at the same or a new location; or (3) Repair or replacement of any major component of the mammography system. (b) The evaluation to determine if equipment specified in subsections (a)(1) through (3) are in compliance with subsection (a) shall be performed by a medical physicist or an individual under the direct supervision of a medical physicist. (c) To use a new radiation machine, a facility shall: (1) Possess a current and valid facility accreditation certificate issued pursuant to section 30315.22 or interim facility accreditation certificate issued pursuant to section 30315.24; (2) Submit the results of tests with measurements and calculated data used to establish compliance with subsection (a), the information specified in section 30315.33(a)(1), (a)(4), (a)(7), (a)(15), (a)(17) and (a)(23) and the calibration record required in section 30316.61(a); and (3) Pass a clinical image review conducted by an entity approved by FDA pursuant to 42 United States Code Section 263b(e)(1)(A) or by the Department in which mammograms shall: (A) Be selected in accordance with the criteria specified in title 21, Code of Federal Regulations, section 900.4(c)(4); (B) Be submitted within 75 calendar days of being notified by the Department that subsections (c)(1) and (2) have been met; and (C) Meet the FDA-accepted attributes as specified in title 21, Code of Federal Regulations, section 900.4(c)(2). (d) To use a radiation machine that was disassembled and reassembled for mammography, a facility shall: (1) Possess a current and valid facility accreditation certificate issued pursuant to section 30315.22 or interim facility accreditation certificate issued pursuant to section 30315.24; (2) Submit the results of tests with measurements and calculated data used to establish compliance with subsection (a), the information specified in section 30315.33(a)(1), (a)(4), (a)(7), (a)(15), (a)(17) and (a)(23) and the calibration record required in section 30316.61(a); and (3) Submit a mammography system evaluation performed by a medical physicist or an individual under the direct supervision of a medical physicist. (e) Documentation of the tests performed, the analysis of data obtained, corrective actions and the effectiveness of those actions taken pursuant to this section shall be maintained in accordance with section 30319.20. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30316.20. Quality Assurance Testing. (a) Each facility using screen-film systems for mammography shall adjust and maintain each processor used to develop mammograms so that the manufacturer's technical development specifications for the mammography film in use are met. Each day mammograms are processed and before processing mammograms the facility shall determine that the processor used to develop mammograms, using the mammography film of the type used clinically, meets the following: (1) Base plus fog-density is within plus 0.03 of the established operating level; (2) Mid-density is within plus or minus 0.15 of the established operating level; and (3) Density difference is within plus or minus 0.15 of the established operating level. (b) Each facility using screen-film systems for mammography shall, each week in which mammography is performed, produce an image of a phantom that meets the requirements of section 30316.22. The test shall be performed prior to mammography on the day the test is performed. Before exposing the phantom an acrylic disc measuring one centimeter in diameter and four millimeters thick shall be placed on the phantom in the image area so it will not obscure details in the phantom and where it cannot cast a shadow on any portion of the AEC detector. The phantom shall then be exposed using the mammography film of the type used clinically and the techniques used for clinical images of a standard breast. The resulting phantom image shall meet the following: (1) The center of the image has an optical density (OD) of at least 1.40 and once an established operating level is determined, the difference does not change by more than plus or minus 0.20 OD when compared to the established operating level; (2) The difference between the OD measured inside the image of the disc and the OD measured adjacent to the image of the disc is at least 0.40 and once an established operating level is determined, the difference does not change by more than plus or minus 0.05 OD when compared to the established operating level; and (3) Obtains a score of at least 4.0 for fibers, 3.0 for specks and 3.0 for masses using the phantom image scoring protocol in section 30316.30. (c) Each facility conducting mammography shall, at intervals not to exceed three months: (1) Test the residual fixer retained in the film to determine that it is no more than 5 micrograms per square centimeter; and (2) Perform a repeat analysis on mammograms repeated or rejected. If the total repeat or reject rate changes from the previously determined rate by more than 2.0% of the total films included in the analysis, the reason(s) for the change shall be determined by the facility. Any corrective actions shall be documented and the results of those corrective actions shall be assessed. Test films, cleared films, or film processed as a result of exposure of a film bin shall not be included in the count for repeat analysis but shall be counted to determine reject rate changes and may be disposed of following completion of the analysis. (d) Each facility conducting mammography shall, prior to initial use and at intervals not to exceed six months: (1) Determine that the optical density attributable to darkroom fog does not exceed 0.05, by performing a test which uses mammography film of the type used clinically in the facility in which the film is exposed such that the film has a mid-density of no less than 1.4 OD, and is exposed to typical darkroom conditions for two minutes while such film, with one-half of the film covered, is placed on the counter top, emulsion side up. If the darkroom has a safelight used for mammography film, it shall be on during this test; (2) Conduct testing on all cassettes used for mammography in the facility for screen-film contact using 40 mesh copper screen during which the entire area of the cassette that may be clinically exposed shall be tested; and (3) Determine that the X-ray system is able to compress the breast with a force of at least 25 pounds and maintain this compression for at least 15 seconds, except that for systems with automatic compression, the maximum force applied without manual assistance shall be greater than 25 pounds and shall not exceed 45 pounds. (e) Each facility conducting mammography shall, annually, ensure that a medical physicist verifies that: (1) Until October 28, 2002, the automatic exposure control (AEC) can maintain film optical density within plus or minus 0.30 of the average of the optical densities measured using homogeneous acrylic thicknesses of 2, 4, and 6 centimeters and the kilovoltage peak (kVp) is varied appropriately for such thicknesses over the kVp range used clinically in the facility. Each image of the homogenous acrylic shall have an optical density (OD) of at least 1.20. If the AEC cannot meet this requirement, a chart shall be posted that specifies appropriate techniques (kVp and density control settings) for different breast thicknesses and compositions so that optical densities within plus or minus 0.30 of the average under phototimed conditions can be produced; (2) After October 28, 2002, the AEC can maintain film optical density within plus or minus 0.15 of the average of the optical densities measured using homogeneous breast-tissue equivalent material thicknesses of 2, 4, and 6 centimeters (cm) and the kVp is varied appropriately for such thicknesses over the kVp range used clinically in the facility. Each image of the homogenous breast-tissue equivalent material shall have an OD of at least 1.20; (3) When the AEC mode is used and the OD is increased or decreased from the normal or baseline setting, the net overall change in OD across the range of clinically used density control settings shall exceed the OD range established under subsection (e)(12) and if that net overall change in OD is equal to or greater than the maximum difference in OD allowed under subsection (e)(12), this change shall be distributed over a minimum of two density control settings removed from the normal or baseline setting; (4) By using the protocol specified in subsection (b), the mammography system, if a screen-film system, can produce a phantom image that meets the following: (A) The center of the image has an OD of at least 1.40; (B) The difference between the OD measured inside the image of the disc and the OD measured adjacent to the image of the disc is at least 0.40; and (C) Obtains a score of 4.0 for fibers, 3.0 for specks and 3.0 for masses using the phantom image scoring protocol in section 30316.30. (D) The difference between the OD measured inside the image of the disc and the OD measured adjacent to the image of the disc is at least 0.40 and the difference is not more than plus or minus 0.05 OD when compared to the facility's established operating level. (5) At the most commonly used clinical settings of kVp, the coefficient of variation of reproducibility of the kVp is equal to or less than 0.02; (6) The kVp is accurate to within plus or minus 5.0% of the indicated or selected kVp at the following: (A) The lowest clinical kVp that can be measured by a kVp test device; (B) The most commonly used clinical kVp; and (C) The highest available clinical kVp. (7) The focal spot condition meets one of the following: (A) Until October 28, 2002, the measured focal spot length (dimension parallel to the anode cathode axis) and width (dimension perpendicular to the anode cathode axis) shall be within the tolerance limits specified in Table 1. If a star pattern is used to evaluate focal spot condition, the star pattern shall, for evaluation of the large focal spot, be no larger than 1.5 degrees and, for evaluation of the small focal spot, be no larger than 1.0 degree. Table 1 Focal Spot Tolerance Limit Nominal Focal Spot Size (mm) Maximum Measured Dimensions Width (mm) Length (mm) 0.10 0.15 0.15 0.15 0.23 0.23 0.20 0.30 0.30 0.30 0.45 0.65 0.40 0.60 0.85 0.60 0.90 1.30 (B) The focal spot condition shall be evaluated by determining the mammography system resolution in accordance with the following and meet the specified criteria: (1) Each mammography system used for mammography, in combination with the mammography screen-film combination used in the facility, shall provide a minimum resolution of 11 cycles/millimeter (mm) (line-pairs/mm) when a high contrast resolution bar test pattern is oriented with the bars perpendicular to the anode-cathode axis, and a minimum resolution of 13 line-pairs/mm when the bars are parallel to that axis; (2) The bar pattern shall be placed 4.5 cm above the breast support surface, centered with respect to the chest wall edge of the image receptor, and with the edge of the pattern within 1 cm of the chest wall edge of the image receptor; (3) When more than one target material is provided, the measurement in subsection (e)(7)(A) shall be made using the appropriate focal spot for each target material; (4) When more than one source-image-distance (SID) is provided, the test shall be performed at the SID most commonly used clinically; and (5) Test kVp shall be set at the value used clinically by the facility for a standard breast and shall be performed in the AEC mode, if available. If necessary, a suitable absorber may be placed in the beam to increase exposure times. The screen-film cassette combination used by the facility shall be used to test for this requirement and shall be placed in the normal location used for clinical procedures. (8) The half-value layer (HVL) of the useful beam is not less than the value specified in Table 2 of section 30308(a)(3) for the minimum HVL. These values, extrapolated to the mammographic range, are shown as follows, except that values not shown in Table 2 may be determined by linear interpolation or extrapolation: Table 2 X-ray Tube Voltage (kilovolt peak) and Minimum HVL Designed Measured Operating Minimum HVL Operating Range (kV) Voltage (kV) (mm of aluminum) Below 50 20 0.20 25 0.25 30 0.30 (9) The coefficient of variation for both air kerma and milliampere-seconds (mAs) does not exceed 0.05; (10) By performance of a test using the techniques the facility uses clinically for a standard breast, the average glandular dose delivered by screen-film systems during a single craniocaudal view of an FDA accepted phantom simulating a standard breast does not exceed 3.0 milligray (mGy) (0.3 rad) per exposure; (11) All systems meet the following: (A) Possess beam-limiting devices that allow the entire chest wall edge of the X-ray field to extend to the chest wall edge of the image receptor and provide means to assure that the X-ray field does not extend beyond any edge of the image receptor by more than 2.0% of the SID; (B) Provide that if a light field that passes through the X-ray beam limitation device is used, it is aligned with the X-ray field so that the total of any misalignment of the edges of the light field and the X-ray field along either the length or the width of the visually defined field at the plane of the breast support surface shall not exceed 2.0% of the SID; and (C) The chest wall edge of the compression paddle does not extend beyond the chest wall edge of the image receptor by more than 1.0% of the SID when tested with the compression paddle placed above the breast support surface at a distance equivalent to standard breast thickness. The shadow of the vertical edge of the compression paddle shall not be visible on the image. (12) The uniformity of screen speed of all cassettes in the facility are tested, and that the difference between the maximum and minimum optical densities do not exceed 0.30. The optical density of the test films shall be no less than 1.4; (13) During the uniformity of screen speed test specified in subsection (e)(12), system artifacts are evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and performed on all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. The optical density of the test films shall be no less than 1.4; (14) System artifacts are evaluated for all available focal spot sizes and target/filter combinations used clinically; (15) Until October 28, 2002, each machine produces, over 3.0 seconds, a minimum output of 4.5 mGy air kerma per second (513 milliroentgen (mR) per second) when operating at 28 kVp in the standard mammography (molybdenum/molybdenum) mode at any SID where the system is designed to operate and when measured by a detector with its center located 4.5 cm above the breast support surface with the compression paddle in place between the source and the detector; (16) After October 28, 2002, each machine produces, over 3.0 seconds, a minimum output of 7.0 mGy air kerma per second (800 milliroentgen (mR) per second) when operating at 28 kVp in the standard mammography (molybdenum/molybdenum) mode at any SID where the system is designed to operate and when measured by a detector with its center located 4.5 cm above the breast support surface with the compression paddle in place between the source and the detector; (17) If the system is equipped with a provision for automatic decompression after completion of an exposure or interruption of power to the system, it provides: (A) An override capability to allow maintenance of compression; (B) A continuous display of the override status; and (C) A manual emergency compression release that can be activated in the event of power or automatic release failure. (18) The calibration of the densitometer and sensitometer used by the facility meets the manufacturer's specifications; and (19) For systems with image receptor modalities other than screen-film, the quality assurance program meets the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems specified in subsection (e)(10). (f) Each facility conducting mammography shall ensure that: (1) The darkroom or the area used to load or unload mammography film is cleaned each day before any mammography is performed; (2) Intensifying screens are cleaned each week using a screen cleaner recommended by the screen manufacturer; and (3) All view boxes used to score phantom images and interpret mammograms are cleaned each week. If the view box used to interpret mammograms is at a different location than where the mammograms are taken, the facility shall ensure that documentation establishing the following is available to personnel and Department inspectors: (A) Physical location(s) where the mammograms produced by the facility are interpreted; (B) For each location, the individual responsible for ensuring the view boxes are cleaned at intervals not to exceed seven calendar days; and (C) A log indicating the date and who cleaned the view boxes. (g) After completion of the tests specified in subsections (a), (b), (d) and (e)(4), (10) and (19), if any of the test results fail to meet the specified criteria, the source of the problem shall be identified and corrective actions shall be taken before any further mammographic examinations are performed or any films are processed using the component of the mammography system that failed the test. (h) Each facility conducting mammography shall, if any of the results of the tests specified in subsections (c), (e)(1) through (3), (5) through (9) and (11) through (18) and (f) fall outside the action limits, identify the source of the problem and take corrective actions within 30 days of the test date. (i) All quality assurance data collected during tests conducted pursuant to this section shall be analyzed and if any problems are detected by analysis of that data, the problems shall be corrected to ensure compliance with this section. (j) Documentation of the tests performed, the analysis of data obtained, corrective actions and the effectiveness of those actions taken pursuant to this section shall be maintained in accordance with section 30319.20. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code s 30316.22. Acceptable Phantoms. (a) A phantom shall not be used unless it is approved by the FDA and is: (1) Mammographic Accreditation Phantom Model 156 produced by Radiation Measurement, Inc.; (2) Mammographic Accreditation Phantom Model 18-220 produced by Nuclear Associates; or (3) Equivalent in thickness to a standard breast and; (A) Contains six nylon fibers with the following diameters: 1. 1.56 millimeters (mm); 2. 1.12 mm; 3. 0.89 mm; 4. 0.75 mm; 5. 0.54 mm; 6. 0.40 mm; (B) Contains five aluminum oxide speck groups, each containing six specks and each speck in the group has the same diameter. The diameter of the specks shall be: 1. 0.54 mm; 2. 0.40 mm; 3. 0.32 mm; 4. 0.24 mm; 5. 0.16 mm; and (C) Contains five nylon massess with decreasing diameters and the following thicknesses: 1. 2.00 mm; 2. 1.00 mm; 3. 0.75 mm; 4. 0.50 mm; 5. 0.25 mm. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30316.30. Phantom Image Scoring Protocol. (a) This section shall apply only to screen-film mammography systems. (b) Phantom images shall be scored in accordance with the following protocol. Each of the following object groups shall be scored separately and shall meet the criteria specified in section 30316.20(b)(3) and (e)(4): (1) Score the fibers as follows: (A) Begin with the largest fiber and move down in size, adding one point for each full fiber until a score of zero or one half is given, then stop. (B) If the entire length of the fiber can be seen and its location and orientation are correct, that fiber receives a score of one. (C) If at least half, but not all, of the fiber can be seen and its location and orientation are correct, that fiber receives a score of one half. (D) If less than one half of a fiber can be seen or if the location or orientation is incorrect, that fiber receives a score of zero. (E) After determining the last fiber to be counted, look at the overall background for artifacts. If there are background objects that are fiber-like in appearance and are of equal or greater brightness than the last visible half or full fiber counted, subtract the last half or full fiber scored. (2) Score the speck groups as follows: (A) Begin with the largest speck group and move down in size adding one point for each full speck group until a score of one half or zero is given, then stop. (B) If at least four of the specks in any group are visualized, the speck group is scored as one. (C) If two or three specks in a group are visualized, the score for the group is one half. (D) If one speck or no specks from a group are visualized, the score is zero. (E) After determining the last speck group to receive a full or one-half point, look at the overall background for artifacts. If there are speck-like artifacts within the insert region of the phantom that are of equal or greater brightness than individual specks counted in the last visible half or full speck group counted, subtract the artifact speck from the observed specks, one by one. Repeat the scoring of the last visible speck group after these deductions. (3) Score the masses as follows: (A) Begin with the largest mass and add one point for each full mass observed until a score of one half or zero is assigned, then stop. (B) Score one for each mass that appears as a minus density object in the correct location that can be seen clearly enough to observe round, circumscribed borders. (C) Score one-half if the mass is clearly present in the correct location, but the borders are not visualized as circular. (D) After determining the last full or half mass to be counted, look at the overall background for artifacts. If there are background objects that are mass-like in appearance and are of equal or greater visibility than the last visible mass, subtract the last full or half point assigned from the original score. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30316.40. Processing of Mammograms and Phantom Images. Each facility possessing a facility accreditation certificate and conducting screen-film mammography shall process phantom images in the processor(s) designated by the facility to process mammograms. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, Health and Safety Code. s 30316.50. Mammographic Image Identification. (a) The following information shall be placed on each mammogram in a permanent, legible manner that does not obscure anatomic structures: (1) Name of patient and an additional patient identifier; (2) Date of examination; (3) View and laterality, which shall be indicated on the image in a position near the axilla using the abbreviations specified in subsections (b) and (c); (4) Facility name, city, state and zip code of the facility that performed the mammogram; (5) Technologist identification; (6) Identification of the cassette/screen used in producing the mammographic image; and (7) Radiation machine identification if there is more than one radiation machine used for mammography at the facility. (b) The following abbreviations shall be used to indicate laterality: (1) Right: "R"; (2) Left: "L". (c) At a minimum, the following abbreviations shall be used to indicate the view: (1) Craniocaudal: "CC"; (2) Mediolateral oblique: "MLO"; (3) Mediolateral: "ML"; (4) Lateromedial: "LM"; (5) Lateromedial oblique: "LMO". Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30316.60. Medical Physicist Survey Reports. (a) Each facility conducting mammography shall undergo an annual survey by a medical physicist or an individual under the direct supervision of a medical physicist, and shall obtain a survey report, dated and signed by the medical physicist and, if an individual performed the survey under the direct supervision of a medical physicist, the individual being supervised, showing: (1) The results with measurements and calculated data used for the mammography system evaluation and the calibration record required in section 30316.61(a); (2) The results of the quality assurance testing evaluation, as well as written documentation of any corrective actions taken and their results; and (3) Written recommendations for corrective actions according to all results required to be in the report, if applicable. (b) The survey report, specified in subsection (a), shall be obtained within 30 calendar days of the date the medical physicist performed and completed the survey. A facility shall require the medical physicist to notify them within 72 hours of the date the tests were performed of any deficiencies that involve any of the items listed in subsection (g) of section 30316.20. (c) The survey report shall identify each radiation machine by the serial number of the X-ray control. (d) The survey report, reviews, and calibration documentation required by this section shall be maintained in accordance with section 30319.20. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 115100, Health and Safety Code. s 30316.61. Instruments Used by Medical Physicists. (a) Instruments used by medical physicists to measure the air kerma or air kerma rate from a radiation machine shall be calibrated at least once every two years and each time the instrument is repaired. The instrument calibration shall be traceable to a national standard and calibrated with an accuracy of plus or minus 6.0% (95% confidence level) in the mammography energy range. The calibration record shall be maintained in accordance with section 30319.20. (b) Instrumentation used by the medical physicist to measure the illumination as specified in section 30316(b)(13) shall be calibrated in units of lux or foot candles and shall meet manufacturer specifications. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 115100, Health and Safety Code. s 30317. General Facility Requirements. (a) The facility shall designate a quality assurance technologist. (b) Tests specified in section 30316.20(a) through (d) and (f) shall be performed by the quality assurance (QA) technologist or by other personnel qualified to perform the tasks. When other personnel are utilized for these tasks, the QA technologist shall ensure that the specified tests are performed correctly. The QA technologist shall maintain documentation of training received by the other personnel. (c) The facility's lead interpreting physician shall verify that the provisions of this section and sections 30316.20, 30316.40, 30316.50, 30316.60, 30317.10, 30317.20, 30317.30, 30317.40, 30317.60, and 30319.20 are met. (d) A facility shall ensure an interpreting physician is available by telephone or in person for consultation when mammographic examinations are performed. (e) A facility shall ensure that mammographic examinations are performed under the supervision, as defined in Health and Safety Code section 114850(g), of an individual who meets the requirements of section 30315.50. (f) Each facility shall provide and require that all operators of radiation machines used for mammography use a chart or manual that specifies technique factors to be utilized relative to the patient's body habitus. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30317.10. Mammography Quality Assurance Program. (a) Each facility shall establish and maintain a mammography quality assurance (QA) program to ensure the safety, reliability, clarity and accuracy of mammography services performed at the facility. A review of the QA program shall be conducted and documented by the lead interpreting physician at intervals not to exceed six months. The QA program shall, at a minimum, include the following: (1) Establishment of operating levels meeting manufacturer specifications by which the criteria specified in section 30316.20(a) is compared. (2) Documentation of accreditation by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A) and certification by FDA; (3) Documentation that each interpreting physician who interprets mammograms for the facility meets the requirements of section 30315.50. (4) Documentation that each mammographic radiologic technologist who performs mammography meets the requirements of section 30315.51; (5) Documentation that each medical physicist who performs the tests specified in section 30316.20(e) meets the requirements of section 30315.52; (6) The QA manual required by section 30317.20; (7) The mammography procedures manual required by section 30317.30; and (8) If the facility is a mobile service provider, a list identifying the physical location where radiation machines are used. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30317.20. Quality Assurance Manual. (a) Each facility that performs mammography shall establish and maintain a written quality assurance (QA) manual. The lead interpreting physician shall document a review of the QA manual at intervals not to exceed six months. At a minimum, the QA manual shall contain: (1) A list of names identifying the following: (A) The lead interpreting physician designated by the facility; (B) The quality assurance technologist; (C) The medical physicist who will perform the tests specified in subsection (e) of section 30316.20; and (D) The company providing processor and equipment services. (2) The procedures to be used to ensure that the tests specified in section 30316.20(a) through (d) and (f) are performed and the criteria have been met; (3) The procedure for correcting each finding that fails to meet the requirements of section 30316.20(a) through (f); (4) Examples of the forms to be used for each test specified in section 30316.20 (a) through (d) and (f); (5) Documentation that equipment used during QA tests specified in section 30316.20 meet manufacturer specifications; (6) The most recent survey report required to be obtained pursuant to section 30316.60 and evidence that instruments used by the medical physicist are calibrated pursuant to section 30316.61; (7) Documentation of all QA tests required to be performed pursuant to section 30316.20(a) through (d) and (f); (8) Documentation of compliance with section 30316.20(g) and (h); (9) Documentation of compliance with section 30316.10 covering the previous two years; (10) Documentation that each interpreting physician, mammographic radiologic technologist and medical physicist has reviewed the manual annually or, if any update has occurred, evidence that the manual has been reviewed by the said individuals; and (11) Documentation of preventive and corrective maintenance, chemistry replacement and cleaning of each processor used to process mammograms. The documentation shall contain the signature of the individual who performed the maintenance. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30317.30. Mammography Procedures Manual. (a) Each facility shall establish a written mammography procedures manual. The lead interpreting physician shall document a review of the manual at intervals not to exceed six months. The mammography procedures manual shall, at a minimum, contain the following: (1) The procedure for corrective action when the images interpreting physicians are asked to interpret are of poor quality and documentation that the procedure is followed; (2) A policy that requires each interpreting physician to participate in the mammography medical outcomes audit as specified in section 30317.60; (3) Examples of mammographic examination reports in lay language for each assessment of findings category and the procedures used to ensure the patient, if the patient does not indicate a health care provider, is referred to a health care provider if the patient's mammogram is interpreted by an interpreting physician as a positive mammogram; (4) The procedure used to inquire whether or not the patient has prosthetic devices implanted in the breast prior to the mammographic examination and evidence that the procedure is followed. The procedure shall specify that except where contraindicated, or unless modified by a physician's directions, patients with such implants shall have mammographic views to maximize the visualization of breast tissue; (5) The procedure to be used by each mammographic radiologic technologist to ensure that prior to each mammographic examination the mammography equipment is disinfected. The procedure shall comply with title 29, Code of Federal Regulations section 1910.1030 as of July 1, 2001, title 8, California Code of Regulations section 5193 and with the manufacturer's recommended procedures for cleaning and disinfection of the mammography equipment used in the facility; (6) The procedures used to comply with section 30317.70 pertaining to consumer complaints; (7) The procedure used to ensure mammographic examination reports are sent as required by section 30317.40; and (8) Documentation that the mammography medical outcomes audit is performed as specified in section 30317.60. (b) Procedures and policies developed to comply with this section shall be followed by the facility. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30317.40. Mammographic Examination Reports. (a) Each facility shall ensure that a written report of the results of each mammographic examination conducted at that facility is prepared and includes at least the following: (1) Name of the patient and an additional patient identifier; (2) Date of the examination; (3) Name of the interpreting physician who interpreted the mammogram; (4) Overall assessment of findings, classified in one of the following categories: (A) "Negative:" Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained); (B) "Benign:" Also a negative assessment; (C) "Probably Benign:" Finding(s) has a high probability of being benign; (D) "Suspicious:" Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant; (E) "Highly suggestive of malignancy:" Finding(s) has a high probability of being malignant; (5) In cases where a final assessment category cannot be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and (6) Recommendations made to the patient's health care provider about what additional actions, if any, should be taken. All clinical questions raised by the referring physician shall be addressed in the report to the extent possible, even if the assessment of findings is negative or benign. (b) Each facility shall ensure that the report specified in subsection (a) is summarized in lay terms and sent no later than 30 calendar days from the date of the mammographic examination to the patient. (c) Each facility shall ensure that the report specified in subsection (a) is sent no later than 30 calendar days from the date of the mammographic examination to the referring physician(s), or if the patient is self-referred, to the physician indicated by the patient or the physician to whom the facility refers the patient. (d) Each facility shall verify that: (1) Patients with an overall assessment of findings of "suspicious" or "highly suggestive of malignancy" and patients needing repeat examinations have received notification; and (2) Physicians have received notification of patients with an overall assessment of findings of "suspicious" or "highly suggestive of malignancy" and needing repeat examinations. (e) If an interpreting physician has given a mammogram an assessment of findings as "suspicious" or "highly suggestive of malignancy," the facility shall attempt to communicate the results to the patient within five working days and the health care provider or if the health care provider is unavailable, to a responsible designee of the health care provider within three working days. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30317.50. Mammogram and Report Retention. Unless otherwise required by law, each facility that performs mammography shall: (a) Unless transferred in accordance with subsection (b), maintain mammograms and the reports specified in section 30317.40 for a minimum of seven years and if no additional mammograms of the patient are taken by the facility, mammograms and reports shall be maintained for a minimum of ten years. (b) Upon request or on behalf of the patient, permanently or temporarily transfer the original mammograms and copies of the patient's mammographic examination reports to a medical institution, a physician or to the patient directly. Any fee charged for this service shall not exceed the documented cost of the service. (c) If the facility will discontinue the performance of mammography, notify the Department prior to discontinuing mammography of how all records kept pursuant to subsection (a) will be maintained. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 123145, Health and Safety Code. s 30317.60. Mammography Medical Outcomes Audit. (a) Each facility possessing a facility accreditation certificate shall collect and review outcome data for all mammograms interpreted by the facility as a positive mammogram, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammographic examination report. Each facility shall analyze these outcome data for all interpreting physicians, both individually and collectively. The lead interpreting physician or an interpreting physician designated by the lead interpreting physician shall perform the analysis. (b) For any cases of an individual diagnosed with breast cancer who was imaged at the facility and whose identity became known to the facility, the facility shall initiate follow-up on surgical and/or pathology results and conduct a review of any mammogram taken prior to the diagnosis of a malignancy. These cases shall be included in the analysis required pursuant to subsection (a). (c) Each facility possessing a facility accreditation certificate shall ensure that the analysis required by subsection (a) is initiated no later than 12 months after the date of issuance of the facility accreditation certificate. The analysis shall be completed within 12 months of the date the analysis was initiated. Subsequent audit analyses shall be performed at least once every 12 months thereafter. (d) The facility's lead interpreting physician or an interpreting physician designated by the lead interpreting physician, shall: (1) Record the dates of the audit period(s); (2) Document the results; (3) Review the medical outcomes audit data; (4) Analyze the results of the audit; (5) Provide the results of the review of a specific interpreting physician to that interpreting physician and the overall results of the review for the facility review; and (6) Provide a written description of any follow-up actions and the nature of the follow-up actions taken. (e) Each facility shall maintain reports, outcome data, analyses and documentation of actions taken specified in this section in accordance with section 30319.20. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30317.70. Consumer Complaints. Each facility possessing a facility accreditation certificate shall: (a) Establish a written procedure for collecting and resolving consumer complaints; (b) Maintain a record of each serious complaint received by the facility in accordance with section 30319.20; (c) Provide to the consumer, upon request, a copy of the facility's procedure required in subsection (a) and instructions for filing serious complaints to the entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A) that accredited the facility; (d) Report unresolved serious complaints to the Department within 30 calendar days of receiving the complaint. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30318.10. Additional Requirements for Mobile Service Providers. (a) Prior to the performance of mammography by a mobile service provider at a location other than a location identified on the application submitted pursuant to section 30315.22 or 30315.23, the provider shall notify the Department. The notification shall include: (1) The name and address of the mobile service provider; (2) The certificate number as shown on the facility accreditation certificate of the mobile service provider; (3) The physical location of the new location where mammography will be performed; (4) The name and telephone number of the individual who is allowing the service to be provided at the new location; (5) If the radiation machine is moved to where the mammographic examinations will be performed, the designated room number within the physical building at the new location of use; and (6) The physical location where mammograms produced at the new location will be processed. (b) After each relocation of the radiation machine and before the performance of mammography on humans, the processor shall be tested to ensure that the criteria specified in section 30316.20(a) are met, and the radiation machine shall be tested to ensure that it meets the requirements of section 30316.20(b)(1) through (3). If a processor is not available at the location where mammography is performed, a phantom image shall be produced by using the procedure specified in section 30316.20(b). The selected kilovoltage-peak and milliampere-seconds (mAs) shall be recorded and compared to the mAs value previously established as meeting the phantom image criteria specified in section 30316.20(b). If the two mAs values are within plus or minus 10 percent of each other, mammography may be performed. If the values exceed the limits, mammography shall not be performed and corrective actions shall be taken to bring the two values within the limit. (c) If a mobile service provider processes mammograms at a location other than where the mammograms are taken: (1) The mammograms shall be transported in a container that protects the film from exposure to light, heat, humidity, radiation, and conditions that may damage the mammograms and processed within 48 hours from the time the mammogram is taken; (2) A log shall be maintained that includes the name of each patient and unique identification number, date, and time of the first exam of each batch, and date and time of batch processing in accordance with section 30319.20; and (3) The container used to transport the mammograms shall be cleaned at intervals not to exceed seven days or if mammography is performed at greater intervals, before the mammograms are transported. (d) Prior to processing mammograms, the provider shall ensure that the test specified in section 30316.20(a) has been met and that the phantom image produced during the test specified in subsection (c) of this section meets the phantom image criteria specified in section 30316.20(b) and if the phantom image fails due to processing problems, the problems shall be corrected prior to processing the mammograms. If the phantom image fails due to a non-processor problem, the provider may process the mammograms, but the lead interpreting physician shall evaluate each mammogram to determine whether any patient must be recalled to have their mammograms repeated. Prior to further clinical use, the mammography system shall be evaluated and problems corrected to ensure that the mammography system is in compliance with all requirements of this article. (e) Documentation demonstrating compliance with this section shall be maintained in accordance with section 30319.20. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30318.11. Posting Requirements for Mobile Service Providers. (a) Each mobile service provider shall ensure the following are kept with each radiation machine used to perform mammography in a mobile setting: (1) All items required to be posted pursuant to section 30255; (2) The mammographic radiologic technologist's certificate issued pursuant to section 30455.1 to the individual performing the mammographic examination and posted so the patient can view it during the examination; (3) For facilities performing mammography, the lead interpreting physician's radiology supervisor and operator certificate issued pursuant to section 30466(d) or 30467 and posted so the patient can view it during the examination; (4) The document required to be posted on the radiation machine pursuant to Health and Safety Code section 115115(b) so the patient can view it during the examination; (5) A copy of the certificate issued by FDA and posted so the patient can view it during the examination; (6) The quality assurance records for on-board processors as specified in section 30316.20(a) for at least the last 30 calendar days. (7) Documentation that, for each location of use visited in the last 30 calendar days, section 30318.10(b) has been met; and (8) The quality assurance manual as specified in section 30317.10. (b) Each provider shall maintain a log that identifies the date and physical location where each radiation machine is used. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code. s 30319. Notification Requirements. (a) Within 30 calendar days of the occurrence of any of the following events, each facility that performs mammography shall inform the Department of the event: (1) Change in the information submitted in response to section 30315.22(a)(1); (2) Change in the identity of the entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A) that accredited the facility; (3) Change in certification status with the FDA; (4) Change in facility personnel and, if adding an interpreting physician, mammographic radiologic technologist, or medical physicist; (5) Change in location of a radiation machine within the facility; (6) Change in facility name or owner; (7) Disassembly and reassembly of any radiation machine or processing equipment; (8) Change in the accreditation status; (9) Change in the facility's contact person. (b) Notifications made pursuant to this section shall be made in writing and contain the name, signature and date of signature of the facility administrator, owner or designee. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30319.20. Record Keeping Requirements. (a) Each facility shall maintain and make available for inspection by the Department the records specified in Table 1 until Department inspection or the time interval specified which ever is greater: Table 1. Record Keeping Requirements Specific Section Type of Record Time Interval for Record Keeping 30315.50 Personnel Qualifications for At least two years physicians after the physician no longer worked at the facility 30455.1 Personnel Qualifications for At least two years mammographic after the technologist no longer radiologic technologists worked at the facility 30315.52 Personnel Qualifications for medical At least two years physicists after the medical physicist no longer worked at the facility 30316.20(a) QA logs 3 years Processor film strips 1 year 30316.20(b) Phantom image score sheets 3 years Phantom images 1 year 30316.20(c)(1) Fixer retention log sheet 3 years Fixer retention test film 1 year 30316.20(c)(2) Repeat Analysis 3 years 30316.20(d)(1) Darkroom fog log sheets 3 years Darkroom test films 1 year 30316.20(d)(2) Screen-film contact log sheets 3 years Screen-film contact test films 1 year 30316.20(d)(3) Compression test log sheet 3 years 30316.20(f) Darkroom cleaning logs 3 years Intensifying screen cleaning logs 3 years View box cleaning logs 3 years 30316.60 Medical Physicist Survey Report, 3 years evaluations & instrument calibration reports 30316.10 Evaluations of new or repaired 3 years equipment 30317.60 Medical Outcomes Audit analysis 3 years 30317.70 Consumer complaints 3 years 30318.10 All mobile service provider documents 3 years (b) Each facility shall maintain records for inspection by the Department showing calibrations, maintenance, and modifications performed on each radiation machine for three years. These records shall include the date of the calibration, maintenance, or modification performed, the name of the individual making the record, and the manufacturer's model and serial number of the X-ray control. (c) Each facility shall maintain records showing the receipt, transfer, and disposal of radiation machines pursuant to section 30293. These records shall include the date of receipt, transfers, or disposal, the name and signature of the individual making the record, and the manufacturer's model and serial number from the X-ray control. Records shall be maintained for inspection by the Department until the facility ceases use and disposes of the radiation machine. Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code. s 30320.90. Grounds for Suspension, Revocation, Amendment or Restriction of a Facility Accreditation Certificate. (a) A facility accreditation certificate may be revoked, suspended, amended or restricted for any of the following: (1) Violation of any provision of the Act, any regulation promulgated pursuant to the Act, any provision of the Radiologic Technology Act, as defined in Health and Safety Code section 27, any regulation promulgated pursuant to the Radiologic Technology Act, or any order of the Department; (2) Failure to pay fees pursuant to sections 30145 or 30145.1; (3) Refusal to submit to clinical image review or mammography review as directed by the Department; (4) Failure of clinical images to pass clinical image review or mammography review; (5) Failure to take corrective action when directed by the Department; (6) Failure to report changes pursuant to section 30319; (7) Procuring a facility accreditation certificate by fraud, or misrepresentation, or because of mistake; (8) Failure to maintain mammograms and reports pursuant to section 30317.50; (9) Failure to ensure the average glandular dose criteria specified in section 30316.20(e)(10) is not exceeded; (10) Failure during a Department inspection to obtain the phantom image score specified in section 30316.20(b)(3); (11) Failure to comply with policies or procedures required to be developed pursuant to section 30317.30; and (12) Suspension or revocation of the facility's certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(a). Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100, 115115, 115145, 115165 and 115215, Health and Safety Code. s 30321. Accountability, Storage, and Transit. (a) In each hospital and clinic possessing sealed sources, there shall be a custodian of such sources. The custodian or his specified alternate shall keep a permanent record of the issue and return of all such sources. (b) When not in use, sources and applicators containing sealed sources shall be kept in a protective enclosure of such material and wall thickness as may be necessary to assure compliance with the United States, title 10, Code of Federal Regulations, part 20, subparts C and D as incorporated by reference in section 30253. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30321.1. Confirming Removal of Implants. The custodian or his specified alternate shall assure that patients treated with removable radioactive source implants remain hospitalized until a source count and a radiation survey of the patient confirm that all implants have been removed. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code; and 10 CFR 35.15(b) (vi) and (vii) (39 FR 26143 and 43 FR 553467). s 30322. Records and Reports of Misadministration. (a) When a misadministration involves a therapy procedure, the licensee shall notify the Department. The licensee shall also notify the referring physician of the affected patient and the patient or the responsible relative or guardian, unless the referring physician agrees to inform the patient or believes, based on medical judgment, that telling the patient or the patient's responsible relative or guardian would be harmful to one or the other, respectively. These notifications shall be made within 24 hours after the licensee discovers the misadministration. If the referring physician, patient, or the patient's responsible relative or guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practicable. The licensee is not required to notify the patient or the patient's responsible relative or guardian without first consulting the referring physician; however, the licensee shall not delay medical care for the patient because of this. (b) Within 15 days after the initial therapy misadministration report to the Department, the licensee shall report, in writing, to the Department and to the referring physician, and furnish a copy of the report to the patient or the patient's responsible relative or guardian if either was previously notified by the licensee, as required by Subsection 30322(a). The written report shall include the licensee's name; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recurrence; whether the licensee informed the patient or the patient's responsible relative or guardian, and if not, why not. The report shall not include the patient's name or other information that could lead to identification of the patient. (c) When a misadministration involves a diagnostic procedure, the radiation safety officer shall promptly investigate its cause, make a record for agency review, and retain the record as directed by Subsection 30322(d). The licensee shall also notify the referring physician and the Department, in writing on Department Form DHS 8453 (7/89) (Diagnostic Misadministration Report) within 15 days, if the misadministration involved use of radioactive material not intended for medical use, administration of dosage five-fold different from the intended dosage, or administration of radioactive material such that the patient is likely to receive an organ dose greater than 2 Rem or a whole body dose of greater than 500 millirem (mRem). Licensees shall use the best available dosimetry data, correcting only for amount of radioactivity administered, to determine whether a report is required. Reports and records required pursuant to thissection shall include reference to the source for dosimetry data used to determine whether a report is required. (d) Each licensee shall retain a record of each misadministration for 10 years. The record shall contain the names of all individuals involved in the event, including the physician, allied health personnel, the patient and the patient's referring physician, the patient's social security number or identification number if one has been assigned, a brief description of the event, the effect on the patient, and the action taken, if any, to prevent recurrence. (e) Aside from the notification requirement, nothing in Subsections 30322(a) through (d) shall affect any rights or duties of licensees and physicians in relation to each other, patients, or responsible relatives or guardians. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30330. General Provisions. (a) This article establishes special radiation safety requirements for use of sources of radiation for radiography, which shall be in addition to other applicable provisions of this regulation and of Groups 1 and 2 of this subchapter. Sections 30331 through 30335 shall apply to radiography using radioactive material and Section 30336 shall apply to radiography using radiation machines. (b) "Radiography," as used in this article, means the examination of the physical structure of materials, other than human beings or animals, by non-destructive methods, utilizing radiation. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801 and 25802, Health and Safety Code. s 30331. Definitions Specific to Radiography. (a) As used in Sections 30332 through 30335: (1) "Permanent radiographic installation" means a shielded installation or structure designed or intended for radiography and in which radiography is regularly performed. (2) "Radiographer" means any individual who performs radiographic operations or who, while in attendance at the site where radiographic operations are being performed, directly supervises such operations; and who is responsible to the user for assuring compliance with the requirements of radiation control regulations and license conditions. (3) "Radiographers' assistant" means any individual who assists a radiographer in the performance of radiographic operations. (4) "Radiographic exposure device" means any device containing a sealed source used for radiography. (5) "Storage area" means any location, facility, or vehicle which is used to store, to transport, or to secure a radiographic exposure device, a storage container, or a sealed source when it is not in use and which is locked or has a physical barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, or source. (6) "Storage container" means a container in which sealed sources are transported or stored. (7) "Source Changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30332. Performance Requirements for Radiographic Exposure Devices, Storage Containers, and Source Changers. (a) For radiographic exposure devices measuring less than 4 inches from the sealed source position to any exterior surface of the device, the radiation level shall not exceed 50 millirems per hour at 6 inches from any exterior surface, wit the sealed source in the shielded or "off" position. (b) For all storage containers, source changers and for radiographic exposure devices measuring 4 inches or more from the sealed source storage position to any exterior surface of the device, the radiation level shall not exceed 200 millirems per hour at any exterior surface and 10 millirems per hour at 40 inches from any exterior surface, with the sealed source in the shielded or "off" position. (c) All radiographic exposure devices and associated equipment manufactured after January 10, 1992 and all radiographic exposure devices and associated equipment used after January 10, 1996 shall comply with the following: (1) Each radiographic exposure device and all associated equipment shall meet the requirements specified in American National Standard N432-1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography", published as NBS Handbook 136, issued January 1981 (ANSI N432). (2) Each radiographic exposure device shall have attached to it a durable, legible, clearly visible label bearing the: (A) Chemical symbol and mass number of the radionuclide in the device; (B) Activity and date on which this activity was last measured; (C) Model number and serial number of the sealed source; (D) Manufacturer of the sealed source; and (E) Licensee's name, address and telephone number. (3) Radiographic exposure devices intended for use as Type B transport containers shall meet the applicable requirements of Section 30373. (4) Modification of any exposure devices and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls or guide tubes would not compromise the safety design features of the system. (5) Also, for radiographic exposure devices and associated equipment that allow the source to be moved out of the device for routine operation: (A) The coupling between the source assembly and the control cable shall be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling shall be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions. (B) The device shall automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device. (C) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device shall be equipped with safety plugs or covers which shall be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter. (D) Each sealed source or source assembly shall have attached to it or engraved in it, a durable, legible, visible label with the words "Danger -Radioactive." The label shall not interfere with the safe operation of the exposure device or associated equipment. (E) The guide tube shall have passed the crushing tests for the control tube as specified in ANSI N432 and a kinking resistance test that closely approximates the kinking forces likely to be encountered during use. (F) Guide tubes shall be used when moving the source out of the device. (G) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube shall be attached to the outermost end of the guide tube during radiographic operations. (H) The guide tube exposure head connection shall be able to withstand the tensile test for control units specified in ANSI N432. (I) Source changers shall provide a system for assuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly. Note: (1) Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. Note: (2) Copies of American National Standard N432-1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography" (published as NBS Handbook 136, issued January 1981) may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402 and from the American National Standards Institute, Inc., 1430 Broadway, New York, New York 10018. s 30332.1. Security of Radiographic Exposure Devices, Storage Containers and Source Changers. (a) Each radiographic exposure device shall be provided with a lock or outer locked container designed to prevent unauthorized or accidental exposure and shall be kept locked at all times except during authorized use or when under the direct surveillance of a radiographer or radiographers' assistant. In addition, during radiographic operations a sealed source assembly shall be secured in the shielded position each time the source is returned to that position. (b) Each storage container and source changer shall be provided with a lock and kept locked when containing a sealed source except when the container is under the direct surveillance of a radiographer or radiographers' assistant. (c) Locked radiographic exposure devices, storage containers and source changers shall be physically secured to prevent tampering or unauthorized removal. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30332.2. Security of Permanent Radiographic Installations. (a) Permanent radiographic installations having high radiation area entrance controls of the types described in Section 30279 shall also meet the following requirements: (b) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation to which this section applies shall have both visible and audible warning signals to warn of the presence of radiation. The visible signal shall be continuously actuated by radiation whenever a source is exposed. The audible signal shall be actuated when an attempt is made to enter the installation while the source is exposed. (c) The alarm system shall be tested at intervals not to exceed three (3) months if a source is exposed in the installation during the three month period commencing from the last test. Alarm system testing is not required for inactive installations, provided that the system is tested prior to first exposure of a source in the installation or at three month intervals, whichever period is greater. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30332.3. Radiation Survey Instruments. (a) Each user shall maintain a sufficient number of calibrated and operable radiation survey instruments, having a range such that 2 milliroentgens per hour through 1 roentgen per hour can be measured, to make physical radiation surveys as required by this regulation. (b) Each radiation survey instrument shall be calibrated at intervals not to exceed 3 months and after each instrument servicing, and a record of the latest date of calibration shall be maintained and kept available for inspection. Note: Authority cited: Sections 208 and 25811, Health and Safety Cod. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30332.4. Leak Testing, Repair, Tagging, Opening, Modification, and Replacement of Sealed Sources. (a) Replacement of any sealed source in a radiographic exposure device, and leak testing, repair, tagging, opening or any other modification of any sealed source shall be performed only by persons specifically authorized by the department to do so pursuant to Group 2 of this subchapter. (b) Leak testing shall be performed in accordance with the requirements of Section 30275 of this regulation. (c) Any sealed source which is not mounted in a radiographic exposure device shall have permanently attached to it a durable tag at least 1 inch square bearing the radiation symbol as prescribed in Section 30278, and at least the following instructions: "Danger -Radioactive Material -Do Not Handle -Notify Civil Authorities If Found." Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30332.5. Quarterly Inventory of Sealed Sources. Each user shall conduct a quarterly physical inventory to account for all sealed sources under his control. Records of the inventories shall be maintained and kept available for inspection and shall include the quantities and kinds of radioactive material, location of sealed sources, and the date of the inventory. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30332.6. Utilization Logs. (a) Each user shall maintain current logs, which shall be kept available for inspection at the address specified in his license, containing the following information for each radiographic exposure device: (1) a description (or make, model, and serial number) of the radiographic exposure device or storage container; (2) the identity of the radiographer to whom assigned; and (3) locations where used and dates of use. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30332.7. Inspection and Maintenance of Radiographic Exposure Devices, Storage Containers and Source Changers. (a) The licensee shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers and source changers to assure proper functioning of components important to safety. (1) The licensee shall check for obvious defects in radiographic exposure devices, storage containers and source changers prior to use each day that the equipment is used. (2) The licensee shall conduct a program for inspection and maintenance of radiographic exposure devices, storage containers and source changers at intervals not to exceed three months. Exposure devices, storage containers and source changers in storage are not subject to inspection and maintenance, provided that inspection and maintenance is completed prior to first use or at three month intervals, whichever period is greater. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30332.8. Reporting Requirements. (a) In addition to the reporting requirements specified in 30295 and under other sections of this subchapter, each licensee shall provide a written report to the department within 30 days of the occurrence of any of the following incidents involving radiographic equipment: (1) Unintentional disconnection of the source assembly from the control cable. (2) Inability to retract the source assembly to its fully shielded position and secure it in this position. (3) Failure of any component (critical to safe operation of the device) to properly perform its intended function. (b) The licensee shall include the following information in each report submitted under subsection (a): (1) A description of the equipment problem. (2) Cause of each incident, if known. (3) Manufacturer and model number of equipment involved in the incident. (4) Place, time and date of the incident. (5) Actions taken to establish normal operations. (6) Corrective actions taken or planned to prevent recurrence. (7) Qualifications of personnel involved in the incident. (c) Reports of overexposure submitted under Title 10, Code of Federal Regulations section 20.2203, incorporated by reference in section 30253, which involve failure of safety components of radiography equipment shall also include the information specified in subsection (b). Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code. s 30333. Training and Supervision for Radiographers and Radiographers' Assistants. (a) No user shall permit any individual to act as a radiographer until such individual: (1) has been instructed in and demonstrated an understanding of the subjects enumerated in Section 30335; (2) has received copies of, instruction in, and demonstrated understanding of, this regulation, applicable provisions of Group 2 of this subchapter, applicable radioactive material licenses, and the user's operating and emergency procedures; and (3) has demonstrated competence to use the radiographic exposure devices, sealed sources, related handling tools, and radiation survey instruments which will be employed in his assignments. (b) No user shall permit any individual to act as a radiographers' assistant until such individual: (1) has received copies of, instruction in, and demonstrated understanding of, the user's operating and emergency procedures; and (2) has demonstrated competence to use, under the direct supervision of a radiographer, the radiographic exposure devices, sealed sources, related handling tools, and radiation survey instruments which will be employed in his assignments. (c) Whenever a radiographer's assistant uses radiographic exposure devices, uses sealed sources or related source handling tools, or conducts radiation surveys required by Section 30334 to determine that the sealed source has returned to the shielded position after an exposure, the radiographer's assistant shall be under the personal supervision of a radiographer. The personal supervision shall include: (1) The radiographer's personal presence at the site where the sealed sources are being used; (2) The ability of the radiographer to give immediate assistance if required; and (3) The radiographer's watching the assistant's performance of the operations referred to in this section. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30333.1. Operating and Emergency Procedures. (a) Each user shall maintain and keep current written operating and emergency procedures which shall include detailed instructions in at least the following matters: (1) The handling and use of radiographic exposure devices and the manner of employment to control and limit radiation exposures to individuals. (2) Methods and occasions for conducting radiation surveys. (3) Methods and occasions for controlling access to radiography areas. (4) Methods and occasions for locking and securing radiographic exposure devices and storage containers. (5) Personnel monitoring and the use of personnel monitoring devices. (6) Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off scale. (7) Transporting sealed sources to field locations, including stowage in vehicles, posting of vehicles and control during transportation. (8) Procedures in the event of an accident, including sealed source handling, minimizing radiation exposure to individuals, and notifying proper persons. (9) Maintenance of records. (10) The inspection and maintenance of radiographic exposure devices, storage containers and source changers. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30333.2. Personnel Monitoring Control. (a) The licensee shall not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations, each such individual wears a direct reading pocket dosimeter, an alarm ratemeter, and either a film badge or a thermoluminescent dosimeter (TLD) except that for permanent radiography facilities where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required. Pocket dosimeters shall have a range from zero to at least 200 milliroentgens and shall be recharged at the start of each shift. Each film badge and TLD shall be assigned to and worn by only one individual. (b) Pocket dosimeters shall be read and exposures recorded daily. The licensee shall retain each record of these exposures for three years after the record is made. (c) Pocket dosimeters shall be checked at periods not to exceed one year for correct response to radiation. Acceptable dosimeters shall read within plus or minus 30 percent of the true radiation exposure. (d) If an individual's pocket dosimeter is discharged beyond its range, the individual's film badge or TLD shall be immediately sent for processing. (e) Reports received from the film badge or TLD processor shall be retained for inspection until the Department terminates each license that authorizes the activity that is subject to the recordkeeping requirement. (f) Each alarming ratemeter shall: (1) Be checked to ensure that the alarm functions properly (sounds) prior to use at the start of each shift; (2) Be set to give an alarm signal at a preset dose rate of 500 mR/hr.; (3) Require special means to change the preset alarm function; and (4) Be calibrated at periods not to exceed one year for correct response to radiation. (g) Acceptable ratemeters shall alarm within plus or minus 20 percent of the true radiation dose rate. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815 and 25876, Health and Safety Code. s 30334. Precautionary Procedures in Radiographic Operations. (a) During each radiographic operation the radiographer or radiographers' assistant shall maintain direct surveillance of the operation to protect against unauthorized entry into a high radiation area, except: (1) where the high radiation area is equipped with a control device or an alarm system as described in the United States, title 10, Code of Federal Regulations, part 20, subpart G as incorporated by reference in section 30253; or (2) where the high radiation area is locked to protect against unauthorized or accidental entry. (b) Areas in which radiography is being performed shall be conspicuously posted as required by the United States, title 10, Code of Federal Regulations, part 20, subpart J as incorporated by reference in section 30253. The limits of a "high radiation area" need not be separately defined and posted if the surrounding "radiation area" is posted and controlled as a "high radiation area." (c) No radiographic operation shall be conducted unless calibrated and operable radiation survey instrumentation per Section 30332.3 is available and used. (d) A survey with a radiation survey instrument shall be made after each radiographic exposure to determine that the sealed source has been returned to its shielded position. The entire circumferences of the radiographic exposure device shall be surveyed. If the radiographic exposure device has a source guide tube, the survey shall include the guide tube. (e) A physical radiation survey shall be made to determine that each sealed source is in its shielded condition prior to locking a radiographic exposure device, storage container or source changer pursuant to Section 30332.1. Records of all such surveys shall be maintained and kept available for inspection. (f) The licensee shall audit the performance of each radiographer and radiographer's assistant at intervals not to exceed (3) months for the pur pose of assessing compliance with Department regulations, license provisions and the licensee's operating and emergency procedures. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code. s 30335. Minimum Subjects to Be Covered in Training Radiographers. (a) Fundamentals of Radiation Safety. (1) Characteristics of gamma radiation. (2) Units of radiation dose and quantity of radioactivity. (3) Hazards of excessive exposure to radiation. (4) Levels of radiation from radiographic exposure devices. (5) Methods of controlling radiation dose. (A) working time (B) working distance (C) shielding (b) Radiation Instrumentation. (1) Use of radiation survey instruments. (A) operation (B) calibration (C) limitations (2) Radiation survey techniques. (3) Characteristics and use of personnel monitoring equipment. (A) film badges (B) pocket dosimeters (C) pocket chambers (D) Thermoluminescent dosimeters (c) Radiographic Equipment. (1) Radiographic exposure devices. (A) using sealed sources (B) X-ray (2) Remote handling equipment. (3) Storage containers. (d) Inspection and Maintenance Performed by Radiographers. (e) Case Histories of Radiography Accidents. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815 and 25876, Health and Safety Code. s 30336. Radiography Employing Radiation Machines. Definitions, for purposes of this regulation, and special requirements for various categories of radiography employing radiation machines are as follows: (a) Cabinet radiography is that which is conducted in an enclosed, interlocked cabinet, such that the radiation machine will not operate unless all openings are securely closed, and the interior of which is so shielded that every location on the exterior meets conditions for an uncontrolled area as specified in the United States, title 10, Code of Federal Regulations, part 20, subpart D as incorporated by reference in section 30253. Cabinet radiography shall be subject to the following special conditions: (1) No user shall permit any individual to operate a cabinet radiography unit until such individual has received a copy of and instruction in, and demonstrated an understanding of, operating procedures for the unit, and has demonstrated competence in its use. (b) Shielded room radiography is that which is conducted in an enclosed room, the interior of which is not occupied during radiographic operations, which is so shielded that every location on the exterior meets conditions for an uncontrolled area as specified in the United States, title 10, Code of Federal Regulations, part 20, subpart D as incorporated by reference in section 30253, and the only access to which is through openings which are interlocked so that the radiation machine will not operate unless all openings are securely closed. Shielded room radiography shall be subject to the following special conditions: (1) No user shall permit any individual to operate a shielded room radiography unit until such individual has received a copy of and instruction in, and demonstrated an understanding of, operating procedures for the unit, and has demonstrated competence in its use. (2) Each user shall supply appropriate personnel monitoring equipment to, and shall require the use of such equipment by, every individual who operates, who makes "set-ups," or who performs maintenance on a shielded room radiography unit. (c) Field radiography is all radiography other than cabinet radiography and shielded room radiography. Field radiography shall be subject to the following special conditions, except as may be explicitly exempted by the department or other official agency specifically designated by the department: (1) No user shall permit any individual to perform field radiography until such individual has been instructed in and demonstrated an understanding of the following subjects: Characteristics of X-radiation Units of radiation dose Radiation hazards Radiation levels from radiation machines Methods of controlling radiation exposure: time, distance, shielding Use of radiation survey instruments: operation, calibration, limitations Radiation survey techniques Characteristics and use of personnel monitoring equipment Use of radiation machines in radiography (2) Each user shall maintain and keep current written operating procedures for the kinds of radiation machines and the kinds of radiographic procedures employed. Such procedures shall include detailed instructions in at least the following: (A) Means to be employed to control and limit exposure to individuals. (B) Methods and occasions for conducting radiation surveys and for controlling access to radiography areas. (C) The use of radiation survey instruments and personnel monitoring devices. (3) No user shall permit any individual to perform field radiography until such individual has received a copy of, instruction in, and demonstrated an understanding of, the user's operating procedures and has demonstrated competence in the kinds of radiographic operations which he will perform. (4) The boundaries of the controlled area for each "setup" shall be determined by a physical radiation survey, and appropriate limitations shall be imposed for controlling access to that area. Such surveys shall be made with a radiation measuring instrument capable of measuring radiation of the energies and at the dose rates to be encountered, which is in good working order, and which has been properly calibrated within the preceding three months or following the last instrument servicing, whichever is later. Survey results and records of boundary locations shall be maintained and kept available for inspection. (5) Areas in which radiography is being performed shall be conspicuously posted as required by the United States, title 10, Code of Federal Regulations, part 20, subpart J as incorporated by reference in section 30253. The limits of a "high radiation area" need not be separately defined and posted if the surrounding "radiation area" is posted and controlled as a "high radiation area." (6) During each radiographic operation, the operator shall maintain direct surveillance of the operation to protect against unauthorized entry into a high radiation area unless entry into such area is positively controlled by other suitable means. (7) Each user shall maintain current utilization logs which shall be kept available for inspection at the address specified on the registration form, containing the following information for each radiation machine: (A) The identity of the machine. (B) The location, date, and the identity of the individual operator for each use. (C) The voltage, current, and exposure time for each use. (8) Each user shall furnish a film badge and either a pocket dosimeter or pocket chamber to, and require their use at all times during radiographic operations by, every individual who conducts field radiography or who otherwise frequents the area during such operations. Pocket dosimeters and pocket chambers shall be capable of measuring doses to at least 200 millirems. They shall be read and doses recorded daily. Pocket dosimeters and pocket chambers shall be checked for current leakage and calibrated no less frequently than once a year. Records of such checks and calibrations, showing dates and results, shall be maintained and kept available for inspection. Each film badge shall be assigned to and worn by only one individual. An individual's film badge shall be immediately processed if his pocket dosimeter or pocket chamber is discharged beyond its range. The film badge reports received from the film badge processor and records of pocket dosimeter or pocket chamber readings shall be maintained and kept available for inspection. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801 and 25802, Health and Safety Code. s 30337. Contraband-Detection Fluoroscopy. When a radiation machine is operated in an occupied area for the purpose of detection of contraband in airline passenger carry-on baggage, it shall meet all of the following requirements: (a) Radiation emitted from the detection equipment shall not, under any condition of use, exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface, or any door or port. (b) The detection equipment shall have a physical barrier, photoelectric safety interlock, or other means which will make the insertion of any part of the human body into the primary X-ray beam impossible. (c) The detection equipment shall have a lock-and-key control which will insure that X-ray generation is not possible with the key removed. (d) There shall be an illuminated indicator which will show when X-rays are being generated; this indicator shall be prominently visible to operating personnel in their normal working positions: (e) In systems in which baggage is placed directly onto the fluoroscopy stage through an open port, the operator's X-ray control switch shall be of the deadman type. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30345.1. Scope. The regulations in this Article shall apply to all licensees or registrants who use sources of radiation for well logging operations including oil, gas, mineral-logging, radioactive markers, or subsurface tracer studies. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30345.2. Definitions. (a) The definitions in section 30100 apply to this article. (b) As used in this article: (1) "Energy compensation source" means a small sealed source (not exceeding an activity of 100 microcuries), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use; (2) "Field station" means a facility where licensed radioactive material or radiation machines may be stored or used and from which equipment is dispatched to temporary jobsites; (3) "Fresh Water Aquifer" means a geologic formation that is capable of yielding fresh water to a well or spring; (4) "Injection tool" means a device used for controlled subsurface injection of radioactive tracer material; (5) "Irretrievable well logging source" means any sealed source containing radioactive material that is pulled off or not connected to the wireline that suspends the source in the well and for which all reasonable effort at recovery has been expended; (6) "Logging assistant" means any individual who, under the personal supervision of a logging supervisor, handles radiation sources that are not in logging tools or shipping containers or who performs surveys required by section 30348.4; (7) "Logging supervisor" means any individual who uses radiation sources or provides personal supervision in the use of radiation sources at a temporary jobsite and who is responsible to the user for assuring compliance with the requirements of this regulation and the conditions of the license; (8) "Logging tool" means a device used subsurface to perform well logging; (9) "Personal supervision" means guidance and instruction by a logging supervisor who is physically present at a temporary jobsite, who is in personal contact with logging assistants, and who can give immediate assistance; (10) "Radioactive marker" means radioactive material used for depth determination or direction orientation. The term includes radioactive collar markers and radioactive iron nails; (11) "Safety review" means a periodic review provided by the user for its employees on radiation safety as it relates to well logging. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, accidents or errors that have been observed, and safety questions by employees; (12) "Source holder" means a housing or assembly into which a sealed source is placed to facilitate the handling and use of the source in well logging; (13) "Subsurface tracer study" means the release of unsealed radioactive material or a substance labeled with radioactive material in a single well for the purpose of tracing the movement or position of the material or substance in the well or adjacent formation; (14) "Surface casing for protecting fresh water aquifers" means a pipe or tube used as a lining in a well to isolate fresh water aquifers from the well; (15) "Temporary jobsite" means a place where licensed radioactive materials or radiation machines are present for the purpose of performing well logging or subsurface tracer studies; (16) "Tritium neutron generator target source" means a tritium source used within a neutron generator tube to produce neutrons for use in well logging applications; (17) "Uranium sinker bar" means a weight containing depleted uranium used to pull a logging tool towards the bottom of a well; (18) "Well" means a drilled hole in which well logging may be performed and includes drilled holes for the purpose of oil, gas, mineral, groundwater, or geological exploration; (19) "Well logging" means all operations involving the lowering and raising of measuring devices or tools which contain radiation sources or are used to detect radiation sources in wells for the purpose of obtaining information about the well or adjacent formations which may be used in oil, gas, mineral, groundwater, or geological exploration; (20) "Wireline" means a cable containing one or more electrical conductors, which is used to lower and raise logging tools in the well-bore. Note: Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 114985, 115060, 115230 and 115235, Health and Safety Code. s 30345.3. Specific License for Well Logging. (a) The applicant for licensure or registration as described in Section 30194 shall meet the requirements specified in that section and any special requirements contained in this section. (b) The applicant shall develop a program for training logging supervisors and logging assistants and submit to the Department a description of this program which specifies: (1) Initial training; (2) On the job training; (3) Annual safety reviews provided by the licensee; (4) Means the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the regulations and licensing requirements and the applicant's operating and emergency procedures; and (5) Means the applicant will use to demonstrate the logging assistant's knowledge and understanding of and ability to comply with the regulations and licensing requirements and the applicant's operating and emergency procedures. (c) The applicant shall submit to the Department written operating and emergency procedures as described in Section 30348.2 or an outline or summary of the procedures that include the important radiation safety aspects of the procedures. (d) The applicant shall establish and submit to the Department its program for annual inspections of the job performance of each logging supervisor to ensure that the Department regulations, license requirements, and the applicant's operating and emergency procedures are followed. Inspection records must be retained for three years after each annual internal inspection. (e) The applicant shall submit a description of its overall organizational structure as it applies to the radiation safety responsibilities in well logging, including specified delegations of authority and responsibility. (f) If an applicant wants to perform leak testing of sealed sources, the applicant shall identify the manufacturers and the model numbers of the leak test kits to be used. If the applicant wants to analyze its own wipe samples, the applicant shall establish procedures to be followed and submit a description of these procedures to the Department. The description shall include: (1) Instruments to be used; (2) Methods of performing the analysis; and (3) Pertinent experience of the person who will analyze the wipe samples. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346. Agreement with Well Owner or Operator. (a) No licensee shall perform well logging services operations with a sealed source unless, prior to commencement of the operation, the licensee has a written agreement with the well operator, well-owner, drilling contractor, or land owner describing who shall be responsible for meeting the following requirements: (1) In the event a sealed source is lodged downhole, a reasonable effort shall be made to recover it. (2) A person shall not attempt to recover a sealed source in a manner which, in the licensee's opinion, could result in its rupture. (3) Radiation monitoring required in Section 30348.5(a) shall be performed. (4) If the environment, any equipment, or personnel are contaminated with licensed radioactive material, they shall be decontaminated before release from the site or release for unrestricted use. (5) If the sealed source is classified as irretrievable after reasonable efforts at recovery have been expended, the following requirements shall be implemented within 30 days: (A) Each irretrievable well logging source shall be immobilized and sealed in place with a cement plug. (B) A mechanical device to prevent inadvertent intrusion on the source shall be set at some point in the well above the cement plug, unless the cement plug and source are not accessible to any subsequent drilling operations. (C) A permanent identification plaque, constructed of long lasting material such as stainless steel, brass, bronze, or monel, shall be mounted at the surface of the well, unless the mounting of the plaque is not practical. The size of the plaque shall be at least 7 inches square and 1/8 inch thick. The plaque shall contain the word "Caution", the radiation symbol (color requirements as described in Section 30278(a) do not have to be met), the date the source was abandoned, the name of the well owner or well operator as appropriate, the well name and well identification number(s) or other designations, an identification of the sealed source(s) by radionuclide and quantity, the depth of the source and the depth to the top of the plug and an appropriate warning such as "Do not reenter this well". (b) The licensee shall retain a copy of the written agreement for three years after the completion of the well logging operation. (c) A licensee may apply, pursuant to Section 30104, for approval on a case-by-case basis of proposed procedures to abandon an irretrievable well logging source in a manner not otherwise authorized in paragraph (a)(5) above. (d) A written agreement between the licensee and the well owner or operator is not required if the licensee and the well owner or operator are part of the same corporate structure or otherwise similarly affiliated. However, the licensee shall still otherwise meet the requirements in Sections (a)(1) through (a)(5). Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.1. Labels, Security and Transportation. (a) The license shall not use a radiation source or source holder or logging tool that contains radioactive material unless the smallest component that is transported as a separate piece of equipment with the radioactive material inside bears a durable, legible, and clearly visible marking or label. The marking or label shall contain the radiation symbol specified in the United States, title 10, Code of Federal Regulations, part 20, subpart J as incorporated by reference in section 30253 and the wording "Danger (or Caution) Radioactive Material". (b) The licensee shall not use a container to store radioactive material unless the container has securely attached to it a durable, legible, and clearly visible label. The label must contain the radiation symbol specified in the United States, title 10, Code of Federal Regulations, part 20, subpart J as incorporated by reference in section 30253 and the wording "CAUTION (or DANGER) RADIOACTIVE MATERIAL. NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)". (c) The licensee shall not transport radioactive material unless the material is packaged, labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set forth in 10 CFR Part 71 (53 FR 21550, Pub. 6/8/88). (d) The licensee shall store each source containing radioactive material in a storage container or transportation package. The container or package must be locked and physically secured to prevent tampering or removal of radiation sources from storage by unauthorized personnel. The licensee shall store radiation sources in a manner which will minimize danger from explosion or fire. (e) The licensee shall lock and physically secure the transport package containing radiation sources in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the radioactive material from the vehicle. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.2. Radiation Detection Instruments. (a) The licensee or registrant shall keep a calibrated and operable radiation survey instrument capable of detecting beta and gamma radiation at each field station and temporary jobsite to make the radiation surveys required by this section and by Section 30275. To satisfy this requirement, the radiation survey instrument must be capable of measuring 0.1 mR per hour through at least 50 mR per hour. Survey instruments acquired before the effective date of these regulations shall be capable of measuring 0.1 mR per hour through at least 20 mR per hour. (b) The licensee or registrant shall have available additional calibrated and operable radiation survey instruments with the sensitivity to detect the low radiation and contamination levels that could be encountered if a sealed source ruptured. The licensee may own the instrument or may have a procedure to obtain them quickly from a second party. (c) The licensee or registrant shall have each radiation survey instrument required under subsection (a) above calibrated: (1) At intervals not to exceed six months and after instrument servicing; (2) At two points located approximately 1/3 and 2/3 of full scale on each scale for linear scale instruments, at mid range of each decade and at two points on each decade for logarithmic scale instruments, and at appropriate points for digital instruments; and (3) So that an accuracy within plus or minus 20 percent of the calibration standards can be demonstrated on each scale. (d) The licensee or registrant shall retain calibration records for at least three years after the date of calibration for inspection by the Department. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.3. Leak Testing of Sealed Sources. Each licensee who uses a sealed source shall have the source tested for leakage as described in Section 30275. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.4. Physical Inventory. Each licensee shall conduct a semi-annual physical inventory to account for all licensed radioactive material received and possessed under the license. The licensee shall retain records of the inventory for three years from the date of the inventory for inspection by the Department. The inventory shall indicate the quantity and kind of radioactive material, the location of the radioactive material, the date of the inventory, and the name of the individual conducting the inventory. Physical inventory records may be combined with leak test records. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.5. Records of Material Use. (a) Each licensee or registrant user shall maintain records for each use of radiation sources showing: (1) The make, model number, and a serial number or a description of each radiation source used; (2) In the case of unsealed radioactive material used for subsurface tracer studies, the radionuclide and quantity of activity used in a particular well and the disposition of any unused tracer materials; (3) The identity of the logging supervisor who is responsible for the radiation sources and the identity of logging assistants present; and (4) The location and date of use of the radiation source. (b) The licensee or registrant shall make the records required by subsection (a) of this section available for inspection by the Department. The records shall be kept for three years from the date of the recorded event. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.6. Design and Performance Criteria for Sealed Sources. (a) A licensee shall not use a sealed source in well logging unless the sealed source: (1) Is doubly encapsulated; (2) Contains licensed radioactive material whose chemical and physical forms are as insoluble and nondispersible as practical; and (3) Meets one of the following: (A) For a sealed source manufactured on or before July 14, 1989, meets the requirements of USASI N5.10-1968, "Classification of Sealed Radioactive Sources"* which is incorporated by reference; or (B) For a sealed source manufactured after July 14, 1989, meets the oil-well logging requirements of ANSI/HPS N43.6-1997, "Sealed Radioactive Sources - Classification"* which is incorporated by reference; or (C) For a sealed source manufactured after July 14, 1989, if the sealed source's prototype has been tested and found to maintain its integrity after each of the following tests: 1. The test source shall be held at - 40 deg. C. for 20 minutes, 600 deg. C. for one hour, and then be subject to a thermal shock test with a temperature drop from 600 deg. C. to 20 deg. C. within 15 seconds; 2. A 5 kg. steel hammer, 2.5 cm. in diameter, shall be dropped from a height of 1 meter onto the test source; 3. The test source shall be subject to a vibration from 25 Hz to 500 Hz at 5 g amplitude for 30 minutes; 4. A one gram hammer and pin, 0.3 cm pin diameter, shall be dropped from a height of 1 m onto the test source; and 5. The test source shall be subjected to an external pressure of 24,600 pounds per square inch absolute (1.695 X 10 [FN7] pascals). (b) The requirements in subsection (a) do not apply to sealed sources that contain radioactive material in gaseous form or to energy compensation sources (ECS). ECSs shall be registered pursuant to section 30192.1(b). _______ *Copies of USASI N5.10-1968, "Classification of Sealed Radioactive Sources" may be obtained from the Department. Copies of American National Standard N43.6- 1997," Sealed Radioactive Sources -Classification" may be purchased from the American National Standards Institute, Inc., Global Engineering Documents, 1819 L Street, NW, Suite 600, Washington DC 20036 or at "http://global.ihs.com" using "ANSI N43.6" as the document number; or the Health Physics Society at http://hps.org/documents/hpsstandardsorder.pdf. Note: Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code. s 30346.7. Inspection, Maintenance and Opening of a Source Holder. (a) Each licensee shall visually check source holders, logging tools, and source handling tools, for defects before each use to ensure that the equipment is in good working condition and that required labeling is present. If defects are found, the equipment must be removed from service until repaired, and a record must be made listing the date of check, name of inspector, equipment involved, defects found, and repairs made. These record shall be retained for three years after the defect is found. (b) Each licensee shall have a program of semi-annual visual inspection and routine maintenance of source holders, logging tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars to ensure that the required labeling is legible and that no physical damage is visible. If defects are found, the equipment must be removed from service until repaired, and a record must be made listing date, equipment involved, inspection and maintenance operations performed, any defects found, and any actions taken to correct the defects. These records must be retained for three years after the defect is found. (c) Removal of a sealed source from a source holder or logging tool, and maintenance on sealed sources or holders in which sealed sources are contained shall not be performed by the licensee unless a written procedure developed pursuant to Section 30348.2 has been approved by the Department. (d) If a sealed source is stuck in the source holder, the licensee shall not perform any operation, such as drilling, cutting, or chiseling on the source holder unless the licensee is specifically approved by the Department. (e) The opening, repair, or modification of any sealed source is prohibited unless performed by persons specifically approved to do so by the Department. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.8. Subsurface Tracer Studies. (a) The licensee shall require all personnel handling radioactive tracer material to use protective gloves and, if required by the license, other protective clothing and equipment. The licensee shall take precautions to avoid ingestion or inhalation of radioactive tracer material and to avoid contamination of field stations and temporary jobsites. (b) The licensee shall not knowingly inject radioactive material into fresh water aquifers unless specifically authorized to do so by the Department. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25608, 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.9. Radioactive Markers. The licensee shall use radioactive markers in wells only if the individual markers contain quantities of radioactive material not exceeding the quantities specified in Section 30235 Schedule A. The use of markers is subject to the requirements of Section 30346.4 only. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.10. Uranium Sinker Bars. The licensee shall use a uranium sinker bar in well logging, only if it is legibly impressed with the words "Caution -Radioactive-Depleted Uranium" and "Notify Civil Authorities (or Company Name) If Found." Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30346.11. Use of Energy Compensation Sources. A licensee may use an energy compensation source (ECS), which is contained in a logging tool, or other tool components, provided the ECS contains quantities of licensed materials not exceeding 100 microcuries. For well logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of sections 30346.3, 30346.4 and 30346.5. For well logging applications without a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of sections 30346, 30346.3, 30346.4, 30346.5 and 30350.3 and the procedure required to be developed and implemented pursuant to section 30348.2(a)(1). Note: Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code. s 30346.12. Use of Tritium Neutron Generator Target Sources. (a) Use of a tritium neutron generator target source shall be subject to the requirements of this article except: (1) Sections 30346, 30346.6, and 30350.3 shall not apply when the: (A) Activity of the source is no more than 30 curies; and (B) Source is used in a well with a surface casing for protecting fresh water acquifers; or (2) Section 30346.6 shall not apply when the: (A) Activity of the source is greater than 30 curies; or (B) Source is used in a well without a surface casing to protect fresh water acquifers. Note: Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code. s 30348.1. Training Requirements. (a) The licensee or registrant shall not permit an individual to act as a logging supervisor until that person: (1) Has completed training in the subjects outlined in subsection (e) of this section; (2) Has received copies of, and instruction in: (A) Regulations contained in Subchapter 4, Title 17, California Code of Regulations; (B) The Department license or registration under which the logging supervisor will perform well logging; and (C) The licensee or registrant's operating and emergency procedures required by Section 30348.2; (3) Has completed on-the-job training and demonstrated competence in the use of radiation sources, remote handling tools, and radiation survey instruments by a field evaluation; and (4) Has demonstrated understanding of the requirements in paragraphs (a)(1) and (2) of this section by successfully completing a written test. (b) The licensee or registrant shall not permit an individual to act as a logging assistant until that person: (1) Has received instruction in applicable requirements of the United States, title 10, Code of Federal Regulations, part 20, subparts C, D, F, G, I, J, K, L, and M as incorporated by reference in section 30253; (2) Has received copies of, and instruction in, the licensee's or registrant's operating and emergency procedures required by Section 30365.2; (3) Has demonstrated understanding of the materials listed in paragraphs (b)(1) and (2) of this section by successfully completing a written or oral test; and (4) Has received instruction in the use of radiation sources, remote handling tools, and radiation survey instruments, as appropriate for the logging assistant's intended job responsibilities. (c) The licensee or registrant shall provide safety reviews for logging supervisors and logging assistants at least once during each calendar year. (d) The licensee or registrant shall maintain a record on each logging supervisor's and logging assistant's training and annual safety review. The training records must include copies of written tests and dates of oral tests. The training records must be retained for three years following the date of termination of employment. Records of annual safety reviews must list the topics discussed and be retained for three years. (e) The licensee or registrant shall include the following subjects in the training required in paragraph (a)(1) of this section: (1) Fundamentals of radiation safety including: (A) Characteristics of radiation; (B) Units of radiation dose and quantity of radioactivity; (C) Hazards of exposure to radiation; (D) Levels of radiation from licensed material; (E) Methods of controlling radiation dose (time, distance, and shielding); and (F) Radiation safety practices, including prevention of contamination, and methods of decontamination. (2) Radiation detection instruments including: (A) Use, operation, calibration, and limitations of radiation survey instruments; (B) Survey techniques; and (C) Use of personnel monitoring equipment; (3) Equipment to be used including: (A) Operation of equipment, including source handling equipment and remote handling tools; (B) Storage, control, and disposal of licensed material; and (C) Maintenance of equipment. (4) The requirement of pertinent regulations, and (5) Case histories of accidents in well logging. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30348.2. Operating and Emergency Procedures. (a) Each licensee shall develop and follow written operating and emergency procedures that cover: (1) The handling and use of radiation sources, including protection of fresh water aquifers, if appropriate; (2) The use of remote handling tools for handling sealed sources and radioactive tracer material except low-activity calibration sources; (3) Methods and occasions for conducting radiation surveys, including surveys for detecting contamination, as required by Section 30348.4 (c)-(e); (4) Minimizing personnel exposure including exposures from inhalation and ingestion of radioactive tracer materials; (5) Methods and occasions for locking and securing stored radioactive materials; (6) Personnel monitoring and the use of personnel monitoring equipment; (7) Transportation of radioactive materials to field stations or temporary jobsites, packaging of licensed materials for transport in vehicles, placarding of vehicles when needed, and physically securing radioactive materials in transport vehicles during transportation to prevent accidental loss, tampering, or unauthorized removal; (8) Picking up, receiving, and opening packages containing radioactive materials, in accordance with the United States, title 10, Code of Federal Regulations, part 20, section 20.1906 as incorporated by reference in section 30253; (9) For the use of tracers, decontamination of the environment, equipment, and personnel; (10) Maintenance of records generated by logging personnel at temporary fieldsites; (11) Inspection and maintenance of sealed sources, source holders, logging tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars as required by Section 30346.10; (12) Actions to be taken if a sealed source is lodged in a well; (13) Notifying proper persons in the event of an accident; and (14) Actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of radioactive materials and actions to obtain suitable radiation survey instruments as required by Section 30346.2(b). Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30348.3. Personnel Monitoring. (a) The user shall not permit an individual to act as a logging supervisor or logging assistant unless that person wears, at all times during the handling of radiation sources, a personnel dosimeter that requires processing to determine the radiation dose. Each personnel dosimeter shall be assigned to and worn by only one individual. Film badges shall be replaced at least monthly and other personnel dosimeters replaced at least quarterly. After replacement, personnel dosimeters shall be sent for processing by the users' dosimetry processor meeting the requirements of section 20.1501(c) of title 10, Code of Federal Regulations incorporated by reference in section 30253 as soon as possible but no later than recommended by the dosimetry processor. (b) The licensee shall provide bioassay services to individuals using radioactive materials in subsurface tracer studies if required by the license. (c) Reports received from the dosimetry processor shall be retained for inspection until the Department terminates each license or registration that authorizes the activity that is subject to the recordkeeping requirement. Note: Authority cited: Sections 100275, 114975, 115000 and 115060, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115110, 115230 and 115235, Health and Safety Code. s 30348.4. Radiation Surveys. (a) The licensee shall make radiation surveys including, but not limited to, the surveys required under subsections (b) through (e) of this section, of each area where radioactive materials are used and stored. (b) Before transporting radioactive materials, the licensee shall make a radiation survey of the position occupied by each individual in the vehicle and of the exterior of each vehicle used to transport radioactive materials. (c) If the sealed source assembly is removed from the logging tool before departure from the temporary jobsite, the licensee shall confirm that the logging tool is free of contamination by energizing the logging tool detector or by using a survey meter. (d) If the licensee has reason to believe that, as a result of any operation involving a sealed source, the encapsulation of the sealed source could be damaged by the operation, the licensee shall conduct a radiation survey, including a contamination survey, during and after the operation. (e) The licensee shall make a radiation survey at the temporary jobsite before and after each subsurface tracer study to confirm the absence of contamination. (f) The results of surveys required under subsections (a) through (e) of this section must be recorded and must include the date of the survey, the name of the individual making the survey, the identification of the survey instrument used, and the location of the survey. The licensee shall retain records of surveys for inspection by the Department for three years after they are made. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30348.5. Radioactive Contamination Control. (a) If the licensee detects evidence that a sealed source has ruptured or radioactive materials have caused contamination, the licensee shall initiate immediately the emergency procedures required by Section 30348.2. (b) If contamination results from the use of radioactive material in well logging, the licensee shall decontaminate all work areas, equipment, and unrestricted areas. (c) During efforts to recover a sealed source lodged in a well, the licensee shall continuously monitor, with an appropriate radiation detection instrument or a logging tool with a radiation detector, the circulating fluids from the well, if any, to check for contamination resulting from damage to the sealed source. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30350. Security. (a) A logging supervisor shall be physically present at a temporary jobsite whenever radioactive materials or particle accelerators are being handled or are not stored and locked in a vehicle or storage place. The logging supervisor may leave the jobsite in order to obtain assistance if a source becomes lodged in a well. (b) During well logging, except when radiation sources are below ground or in shipping or storage containers, the logging supervisor or other individual designated by the logging supervisor shall maintain direct surveillance of the operation to prevent unauthorized entry into a "controlled area", as defined in title 10, Code of Federal Regulations, section 20.1003, as incorporated by reference by section 30253. Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and Safety Code. s 30350.1. Documents and Records Required at Field Stations. (a) Each licensee or registrant shall maintain the following documents and records at the field station: (1) A copy of the California Code of Regulations, Title 17; Subchapter 4; (2) The license or registration authorizing the use of radioactive material or particle accelerators; (3) Operating and emergency procedures required by Section 30348.2. (4) The record of radiation survey instrument calibrations required by Section 30346.2. (5) The record of leak test results required by Section 30346.3. (6) Physical inventory records required by Section 30346.4. (7) Utilization records required by Section 30346.5. (8) Records of inspection and maintenance required by Section 30346.7. (9) Training records required by Section 30348.1; and (10) Survey records required by Section 30348.4. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30350.2. Documents and Records Required at Temporary Jobsites. (a) Each licensee or registrant conducting operations at a temporary jobsite shall maintain the following documents and records at the temporary jobsite until the well logging operation is completed: (1) Operating and emergency procedures required by Section 30348.2. (2) Evidence of latest calibration of the radiation survey instruments in use at the site required by Section 30346.2. (3) Latest survey records required by Section 30348.4(a)(2), (3), and (5). (4) The shipping papers for the transportation of radioactive materials required by Group 4, Article 1 of this chapter; and (5) When operating under reciprocity pursuant to Section 30225 of this chapter, a copy of the U.S. Nuclear Regulatory Commission or Agreement State license authorizing use of radioactive materials. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30350.3. Notification of Incidents and Lost Sources; Abandonment Procedures for Irretrievable Sources. (a) The licensee shall immediately notify the Department by telephone and subsequently, within 30 days, by confirmation letter if the licensee knows or has reason to believe that a sealed source has been ruptured. The letter must designate the well or other location, describe the magnitude and extent of the escape of radioactive materials, assess the consequences of the rupture, and explain efforts planned or being taken to mitigate these consequences. (b) If a sealed source becomes lodged in a well, and when it becomes apparent that efforts to recover the sealed source will not be successful, the licensee shall: (1) Notify the Department by telephone of the circumstances that resulted in the inability to retrieve the source and obtain approval to implement abandonment procedures; (2) Advise the well owner or operator, as appropriate, of the abandonment procedures under Section 30366.3; and (3) Either ensure that abandonment procedures are implemented within 30 days after the sealed source has been classified as irretrievable or request an extension of time if unable to complete the abandonment procedures. (c) The licensee shall, within 30 days after a sealed source has been classified as irretrievable, make a report in writing to the Department. The licensee shall send a copy of the report to each appropriate State or Federal agency that issued permits or otherwise approved of the drilling operation. The report shall contain the following information: (1) Date of occurrence; (2) A description of the irretrievable well logging source involved including the radionuclide and its quantity, chemical, and physical form; (3) Surface location and identification of the well; (4) Results of efforts to immobilize and seal the source in place; (5) A brief description of the attempted recovery effort; (6) Depth of the source; (7) Depth of the top of the cement plug; (8) Depth of the well; (9) Any other information, such as a warning statement, contained on the permanent identification plaque; and (10) State and Federal agencies receiving a copy of this report. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30353. Particle Accelerators For Well Logging. (a) Registrants who use particle accelerators for well logging purposes shall comply with Group 1.5, and Articles 1, 3, 4, and 13 of Group 3. (b) No registrant shall permit above ground testing of particle accelerators designed for use in well logging which results in the production of radiation except in areas or facilities controlled or shielded so that the requirements of the United States, title 10, Code of Federal Regulations, part 20, subpart C and D as incorporated by reference in section 30253 are met. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, and 25815, Health and Safety Code. s 30355. Appendix A. Concentrations in Air and Water Above Natural Background. Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30356. Appendix B. s 30357. Form RH 2364 -Notice to Employees. s 30358. Form RH 2365 -Current Occupational External Radiation Exposure. Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code. s 30373. Transportation Regulations. (a) No person shall transport any radioactive material outside the confines of that person's facility or other authorized location of use, or offer any radioactive material to a carrier for transportation, unless that person complies with applicable requirements of the regulations, appropriate to the mode of transport, of the United States Federal Government in 10 CFR, Part 71 (as effective November 30, 1988) insofar as such regulations relate to the packaging of radioactive material, marking and labeling of the packages, loading and storage of packages, placarding of the transportation vehicle, monitoring requirements and accident reporting. (b) Persons are exempt from this regulation to the extent that they transport any radioactive material or offer any radioactive material to a carrier for transportation where such transportation is subject to the exclusive jurisdiction of the United States Federal Government. (c) Physicians are exempt from the requirements of this section to the extent that they transport radioactive material for use in the practice of medicine. Note: (1) Authority cited: Sections 208, 25611, 25651 and 25811, Health and Safety Code. Reference: Sections 25606 and 25611, Health and Safety Code. Note: (2) Copies of Title 10, Code of Federal Regulations -Energy, are for sale by the Superintendent of Documents, U.S.Government Printing Office, Washington, D.C. 20402. s 30385. Authority. s 30390. General Definitions. s 30393. Participation in Control Program. Participation in the State radiation control program shall be pursuant to an approved contract between the Department and the local health department. A local health department desiring to participate in the State radiation control program within its area of jurisdiction shall apply to the Department. Note: Authority cited: Sections 208, 25651 and 25811, Health and Safety Code. Reference: Sections 25801, 25810, 25875 and 25876, Health and Safety Code. s 30394. Application for Participation. Application shall be made in writing, and shall set forth: (a) The names and qualifications of personnel to be assigned to the radiation control program; (b) The numbers and types of radiation survey instruments available; (c) The administrative relationship between the radiation control program and other programs of the local health department; and (d) A showing that the radiation control program proposed by the local health department is compatible with standards imposed upon the State by the U.S. Nuclear Regulatory Commission pursuant to the agreement contained in the Health and Safety Code, Section 25876, and the general policy statement "Guidelines for NRC Review of Agreement State Radiation Control Programs" (46 FR 59341). Note: Authority cited: Sections 208, 25651 and 25811, Health and Safety Code. Reference: Sections 25801, 25810, 25875 and 25876, Health and Safety Code. s 30395. Contract Authorizing Participation. (a) An application will be approved if the Department determines with the concurrence of the Department of Industrial Relations that the showings required by Section 30394 are complete. (b) Any authorization pursuant to this article shall be in the form of a contract setting forth, as a minimum: (1) Duties and responsibilities of the local health department; (2) Conditions of financial reimbursement to the local health department; and (3) Terms and conditions for termination of the contract. Note: Authority cited: Sections 208, 25651 and 25811, Health and Safety Code. Reference: Sections 25801, 25810, 25875 and 25876, Health and Safety Code. s 30397. Terms of Participation. s 30400. Fluoroscopy. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668, Health and Safety Code. s 30400.5. Approved Continuing Education Credit. "Approved continuing education credit" means one hour of instruction received in subjects related to the application of X-ray to the human body and accepted for purposes of credentialing, assigning professional status or certification by the: (a) American Registry of Radiologic Technologists; (b) Medical Board of California; (c) Osteopathic Medical Board of California; (d) California Board of Chiropractic Examiners; (e) Board of Podiatric Medicine; or (f) Board of Dental Examiners. Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106995, 114840, 114845, 114870(b), (c) and (e), Health and Safety Code. s 30400.40. Fluoroscopy. "Fluoroscopy" means a radiological examination utilizing fluorescence for the observation of the transient image. Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106965, 107110, 114870(b), (c) and (e), Health and Safety Code. s 30400.60. Mammographic Examination. "Mammographic examination" means the performance of mammography on a human being. Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106995, 114845, 114870(b) and (c), Health and Safety Code. s 30400.85. Radiography. "Radiography" means the recording of static images on any suitable medium by passing X-rays through portions of the human body, and includes one or more of the following: (a) Positioning the patient. (b) Selecting exposure factors. (c) Exposing the patient and the recording medium to X-rays. Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106965, 106975, 107045, 107110, 114850, 114870(b), (c) and (e), Health and Safety Code. s 30400.95. X-ray Bone Densitometry. "X-ray bone densitometry" means a radiologic examination of all or part of the skeleton utilizing X-rays from an X-ray source which is mechanically ganged to a detector for scanning all or part of the skeleton under computer control. Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106965, 107045 and 114870(c), Health and Safety Code. s 30401. Radiography. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668, Health and Safety Code. s 30401.6. X-ray Bone Densitometry. Note: Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114870(c), Health and Safety Code. s 30402. Special Permits. (a) To obtain a special permit an applicant shall have on file with the Department a complete application. (b) The Department considers an application for a special permit complete if all of the following conditions have been met: (1) Application is made on forms furnished by the Department. (2) Fee is paid pursuant to Section 30408. (3) The application is accompanied by: (A) A statement from a licentiate of the healing arts who holds a certificate or permit issued pursuant to Sections 30466 or 30467 attesting that efforts to employ a Certified Radiologic Technologist were unsuccessful. (B) A copy of a notice of employment opportunity for a radiologic technologist in a local newspaper or periodical for the position for which the special permit is being sought. (4) The Department ascertains, by reviewing X-ray machine registration records, that no other medical X-ray facility capable of providing the same radiologic health care that would be delivered at the applicant's facility is available in the locality where the special permit is being sought. (c) Special permits shall be issued for a period of time not to exceed one year. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25670, Health and Safety Code. s 30403. Requirements for Continuing Education and Performance of Mammographic Examinations. (a) Each individual certified or permitted pursuant to sections 30440, 30444, and/or 30451 shall, in the two years immediately preceding the expiration date of the certificate or permit, earn 24 approved continuing education credits, except that each individual who is certified pursuant to sections 30440(a) and 30455.1 shall meet the requirements of subsection (c). (b) Each individual certified or permitted pursuant to sections 30466 and 30467 shall, in the two years immediately preceding the expiration date of the certificate or permit, earn 10 approved continuing education credits. (c) Each individual certified pursuant to sections 30440(a) and 30455.1 shall, in the two years immediately preceding the expiration date of the certificate or permit: (1) Earn 24 approved continuing education credits, 10 of which shall be in mammography; and (2) Perform at least 200 mammographic examinations. (d) The two-year period referred to in subsections (a), (b) and (c) and in section 30403.5 shall begin on the expiration date of the certificate or permit: (1) In the year 2001 for individuals with a certificate or permit that ends in an odd number; and (2) In the year 2002 for individuals with a certificate or permit that ends in an even number. Note: Authority cited: Sections 100275 and 114870(a) Health and Safety Code. Reference: Sections 106965, 106995, 107015, 107070, 107110, 114840, 114845, 114870(b), (c) and (e), Health and Safety Code. s 30403.5. Renewal Procedures. Each individual seeking renewal of a certificate or permit issued pursuant to this subchapter shall: (a) At least 30 calendar days prior to the expiration date on the certificate or permit, submit to the Department a complete application for renewal consisting of the applicant's name, mailing address, telephone number, and certificate or permit type and number. (b) Every two years, submit to the Department the following information for each approved continuing education credit as required by section 30403 subsections (a), (b) and (c)(1): (1) The identity of the group listed in section 30400.5 that has accepted the instruction; (2) The provider of the instruction; (3) The title, if any, of the instruction; (4) The date(s) of the instruction; and (5) The location of the instruction; (c) Submit to the Department an attestation every two years of having completed mammographic examinations as required pursuant to section 30403 subsection (c)(2); and (d) Pay the fee as required by section 30408. Note: Authority cited: Sections 100275 and 114870(a) Health and Safety Code. Reference: Sections 106965, 106995, 107015, 107070, 107110, 114840, 114845, 114870(b), (c) and (e), Health and Safety Code. s 30403.8. Recordkeeping Requirement. Each individual certified or permitted pursuant to this subchapter shall maintain the document(s) that evidence the individual having earned approved continuing education credits and/or completing mammographic examinations for five years following the dates the credits were earned and/or the mammographic examinations were completed. Such document(s) shall be made available to the Department upon request. Note: Authority cited: Sections 100275 and 114870(a) Health and Safety Code. Reference: Sections 106965, 106995, 107015, 107035, 107070, 107110, 114840, 114845, 114870(b), (c) and (e), Health and Safety Code. s 30404. Display. (a) Any radiologic technologist who holds a certificate pursuant to Section 30440 or a fluoroscopy permit pursuant to Section 30451 shall prominently display such certificate or permit, or a copy thereof, at each place where the technologist performs activities which require a radiologic technologist certificate or permit. (b) Any limited permittee who holds a permit pursuant to Section 30444 shall prominently display such permit, or a copy thereof, at each place where the limited permittee performs functions which require a limited permit. (c) Any licentiate who holds a certificate or permit pursuant to Sections 30466 or 30467 shall prominently display such certificate or permit, or a copy thereof, at each place of practice where the licentiate performs activities which require a licentiate certificate or permit. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25671 and 25699, Health and Safety Code. s 30405. Deadlines. (a) For purposes of this subchapter: (1) Submission of an application or information, documents, or fees supporting an application shall be deemed to occur on the date the application, information, documents, or fees are received by the Department. (2) An application is considered complete when all documents, information, or fees required to be submitted on or with the application have been received by the Department, and the applicant has passed required examinations. (3) Written notification by the Department to applicants shall be deemed to occur on the date the notifications are postmarked. (b) The Department shall notify the applicant, within 30 calendar days of submission of an application for any certificate or permit issued under this subchapter, of one of the following: (1) That the application is complete and the Department's decision regarding the application. (2) That the application is not accepted for filing and what specific information, documentation or fee the applicant shall submit within 30 calendar days in order for the Department to consider the application acceptable. (3) That the application is acceptable and what examinations the applicant shall pass within 180 calendar days in order to complete the application. (c) The Department shall deem an application to have been withdrawn by any applicant who fails to: (1) Within 30 calendar days of notification pursuant to subsection (b), respond to the Department's request to submit specific information, documentation or fee, or (2) Within 180 calendar days of notification pursuant to subsection (b), pass Department-approved examinations. (d) Any applicant deemed by the Department to have withdrawn an application pursuant to paragraph (c) may reapply by submitting a new application. (e) The Department's time periods for processing an application, from the date the initial application is received by the Department to the date the application is complete and the final decision is made regarding any certificate or permit issued under this subchapter are as follows: (1) The median time for processing an application is 90 calendar days. (2) The minimum time for processing an application is one day. (3) The maximum time for processing an application is 240 calendar days. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 15376, Government Code. s 30406. Change of Name and Address. Each individual certified or permitted pursuant to this subchapter shall report to the Department any change of name or mailing address within 30 calendar days of the change. Note: Authority cited: Sections 100275 and 114870(a) Health and Safety Code. Reference: Sections 106965, 107015, 107110, 114870(b), (c) and (e), Health and Safety Code. s 30408. Fees. (a) For any certificate or permit issued pursuant to this subchapter in accordance with the Radiologic Technology Act (Health and Safety Code section 27(f)), the application fee shall be $85.00 for licentiates and $75.00 for technologists and limited permittees. If required to pass an examination to obtain the certificate or permit, the examination fee shall be $75.00 for each examination administered by the Department or as specified by the entities or organizations designated by the Department to administer Department-approved examinations. (b) The fee for repeating an examination failed within the previous 12 months shall be $75.00 per examination. (c) Each individual applying to renew a certificate or permit shall pay an annual renewal fee of $35.00. The renewal fee shall be collected biennially and such fee shall be twice the annual renewal fee. (d) The fee for a duplicate certificate or permit shall be $1.09. (e) The penalty fee for renewal of any expired certificate or permit shall be $5.44 and shall be in addition to the fee for renewal. (f) Failure to pay the annual fee for renewal on or before the expiration date of the certificate or permit shall automatically suspend the certificate or permit. If the annual renewal fee is not paid within six months following such date, the certificate or permit shall be revoked. A certificate or permit revoked for nonpayment of the renewal fee may be reinstated within five years from the time of revocation upon payment of the penalty fee specified in subsection (e) plus twice the annual renewal fee specified in subsection (c). If the application for reinstatement is not made within five years from the date of suspension of the certificate or permit, the certificate or permit shall be canceled and shall not be subject to reinstatement. (g) Each person applying to be an approved school of radiologic technology shall pay an application fee of $1,175.00 with the application for approval. (h) Each approved school of radiologic technology shall, on or before the anniversary of the effective date of approval, pay a fee of $190.00 and, for each physical location where clinical education is given, a fee of $110.00 (i) Each person approved as a limited permit X-ray technician school pursuant to sections 30424, 30425, 30427, or 30427.2 that requests approval to provide training in a new limited permit category as specified in sections 30442 and 30443 shall pay an application fee of $430.00 with the application for approval. (j) Any school failing to pay the annual fees by the anniversary of the effective date of the approval shall immediately cease operations requiring Department approval until such time as the annual fees and a late fee of 25 percent of the annual fees has been paid. (k) Fees required by this section shall be nonrefundable. Note: Authority cited: Sections 100275, 114870 and 115000, Health and Safety Code. Reference: Sections 107080, 107085, 107090, 107095 and 107100, Health and Safety Code. s 30420. Application Procedure. Applicants seeking approval of a school or a course of study in radiologic technology shall submit to the Department all of the following: (a) An application on forms furnished by the Department. (b) Documents which explain the nature and extent of education and training to be offered. (c) Course descriptions, curricula plans, and study plans. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(d) and 25686, Health and Safety Code. s 30421. Diagnostic Radiologic Technology Schools. (a) In order to be approved by the Department as a diagnostic radiologic technology school, a training facility shall include in its curriculum all requirements of subsections (b) through (g), inclusive, of this section. (b) The course of study shall meet at least the following: (1) 500 hours of formal classroom instruction. (2) 50 hours of general radiographic laboratory. (3) 75 hours of positioning laboratory. (4) 25 hours of radiation protection laboratory. (5) 1850 hours of supervised clinical education. (c) The classroom instruction shall include at least the following: Subject Hours of Instruction (1) Radiation protection pertaining to radiography........... 50 (2) Introduction to radiologic technology.................... 5 (3) Professional ethics...................................... 5 (4) Anatomy and physiology................................... 50 (5) Medical terminology...................................... 15 (6) Physics and electricity.................................. 40 (7) Principles of radiographic exposure...................... 30 (8) Film/image receptor processing (theory and equipment).... 10 (9) Survey of diseases....................................... 10 (10) Nursing procedures...................................... 15 (11) Pediatric radiography................................... 10 (12) Procedures involving contrast media..................... 80 (13) Departmental administrative and office procedures....... 5 (14) Equipment and accessory care............................ 5 (15) Radiographic positioning................................ 70 (16) Film critique........................................... 80 (17) Senior student seminar.................................. 20 (d) In the general radiographic laboratory each student shall perform experiments, using phantoms, to illustrate at least the following: (1) X-ray output (effects of kilovoltage, milliamperage, filtration, distance, and heel effect). (2) Radiographic contrast -subject and film (kilovoltage, filtration, scatter radiation, film type and speed, exposure, processing). (3) Control of scatter radiation (collimation, field size accuracy, X-ray/light-field congruence, grids, air gap technique) (4) Intensifying screens (type and speed, screen-film contact, cassette types). (5) Image sharpness (penumbra, inverse square law, source and subject-film distance, size of the focal spot, motion, magnification and distortion). (6) Quality control experiments. (e) In the positioning laboratory each student shall: (1) Position simulated patients for routine X-ray procedures to illustrate different patient care situations. (2) Perform on phantoms X-ray procedures to illustrate the selection of exposure factors, proper positioning, film and other image receptor processing/developing techniques. (f) In the radiation protection laboratory each student shall perform experiments to illustrate at least all of the following: (1) Methods of reducing dose per exposure to patient (limiting exposure field, use of filters, optimum kilovoltage techniques, film-intensifying screen combinations, gonadal shielding, source-film distance). (2) Reduction of dose to personnel (shielding, such as X-ray tube housing and primary protective barriers, protection against secondary or scatter radiation). (3) Safe practice for protection of personnel (monitoring, use of protective shielding and distance in portable work, use of protective clothing). (g) In the supervised clinical education each student shall perform or assist in the performance of not less than the following number of radiographic procedures: Procedures Number (1) Chest........................................... 200 (2) Bony skeleton................................... 400 (3) Gastrointestinal and genitourinary.............. 200 (4) Vascular and contrast studies................... 50 (5) Special studies and X-ray imaging modalities.... 50 (6) Bedside and surgical............................ 50 (h) Each training facility approved as a diagnostic radiologic technology school shall meet and maintain all standards set forth in this section. Failure of an applicant to meet any of these standards shall be grounds for denial of approval. Failure of an approved diagnostic radiologic tech nology school to maintain any of these standards shall be grounds for suspension or revocation of approval. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(d) and 25686, Health and Safety Code. s 30422. Therapeutic Radiologic Technology Schools. (a) In order to be approved by the Department as a therapeutic radiologic technology school, a training facility shall include in its curriculum all requirements of subsections (b) through (g), inclusive, of this section. (b) The course of study shall meet at least all of the following: (1) 455 hours of formal classroom instruction. (2) 15 hours of general radiographic laboratory. (3) 60 hours of physics and radiation protection laboratory. (4) 75 hours of radiotherapy laboratory. (5) 1500 hours of supervised clinical education. (c) The classroom instruction shall include at least the following: Subject Hours of Instruction (1) Radiation protection pertaining to radiation therapy.......................................... 50 (2) Introduction and orientation........................... 5 (3) Professional ethics.................................... 5 (4) Anatomy and physiology................................. 50 (5) Medical terminology.................................... 10 (6) Physics of radiation therapy........................... 85 (7) Mathematics............................................ 15 (8) Pathology.............................................. 25 (9) Nursing procedures..................................... 25 (10) Radiobiology and chemotherapy......................... 25 (11) Principles of radiation therapy....................... 25 (12) Technical radiation therapy and treatment planning.... 55 (13) Intercavitary and interstitial therapy................ 25 (14) Principles of radiography............................. 35 (15) Senior student seminar................................ 20 (d) In the general radiographic laboratory each student shall perform experiments, using phantoms, to illustrate at least the following: (1) X-ray output (effects of kilovoltage, milliamperage, filtration, distance). (2) Radiographic contrast (kilovoltage, filtration, scatter, film type, exposure, processing). (3) Control of scatter (collimation, grids). (4) Intensifying screens (type, screen-film contact, cassette). (5) Sharpness (penumbra, inverse square law, source and phantom-film distance, size of the focal spot, motion, magnification and distortion). (e) In the physics and radiation protection laboratory each student shall perform experiments that will illustrate at least all of the following: (1) Method of reducing dose to the patient (shutters, cones, collimators, filters, optimum exposure techniques, optimum film and screen use, gonadal shielding, source-film distance). (2) Reduction of dose to personnel (shielding of the X-ray tube and treatment room, protection against secondary radiation, monitoring, protective clothing). (3) Quality control procedures: (A) Identification of parts of basic therapy equipment. (B) Functions of various types of therapy equipment. (C) Methods of calculating dosage throughout the irradiated area. (D) Use of computer in treatment planning. (E) Calibration of therapy equipment and use of ionization chambers. (F) Care and safe operation of equipment (testing for safety, interlocks, shutters, communication and viewing systems, erratic operation of machinery, daily inspection and routine maintenance, emergency procedures). (G) Handling of radioactive materials (use of radiation measuring devices, area surveys, wipe and leak tests, storage and disposal, emergency decontamination). (f) In the radiotherapy procedures laboratory each student shall: (1) Manipulate treatment and simulator units. (2) Operate darkroom equipment and accessories, including automatic processor. (3) On simulated patients and phantoms, position and select exposure factors for routine localization procedures such as chest, abdomen, head and neck, and pelvis. (4) Position simulated patients and phantoms for treatment of chest, pelvis and abdomen. (g) During the supervised clinical education each student shall perform or assist in performing radiation therapy procedures involving the following: (1) Head and neck. (2) Central nervous system. (3) Respiratory system. (4) Digestive system. (5) Reproductive system. (6) Urinary system. (7) Endocrine system. (8) Circulatory system. (9) Reticulo-endothelial system. (10) Skin. (11) Soft tissue. (12) Pediatric. (13) Metastases. (h) Each training facility approved as a therapeutic radiologic technology school shall meet and maintain all standards set forth in this section. Failure of an applicant to meet any of these standards shall be grounds for denial of approval. Failure of an approved therapeutic radiologic technology school to maintain any of these standards shall be grounds for suspension or revocation of approval. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(d) and 25686, Health and Safety Code. s 30423. Radiologic Technologist Fluoroscopy Permit Schools. (a) In order to be approved by the Department as a radiologic technologist fluoroscopy permit school, a school shall offer a course of study that includes in its curriculum all requirements of subsections (b) and (c) of this section. (b) The classroom instruction shall include at least the following: Subject Hours of Instruction (1) Fluoroscopy regulations and radiation safety...... 10 (2) Fluoroscopy equipment............................. 5 (3) X-ray image intensifiers.......................... 4 (4) Television, including closed circuit equipment.... 4 (5) Image recording and image recording equipment..... 6 (6) Special fluoroscopy equipment..................... 5 (7) Mobile image intensified units.................... 2 (8) Anatomy and physiology of the eye................. 2 (9) Three-dimensional and radiological anatomy........ 2 (c) At least 15 hours of laboratory in which each student shall conduct experiments on phantoms to illustrate at least the following: (1) Methods of reducing dose to patients during fluoroscopy procedures. (2) Methods of reducing exposure to self and personnel. (3) Image recording during the exposure of phantom. (4) Quality control of fluoroscopy equipment. (d) Each training facility approved as a radiologic technology fluoroscopy permit school shall meet and maintain all standards set forth in this section. Failure of an applicant to meet any of these standards shall be grounds for denial of approval. Failure of an approved radiologic technology fluoroscopy permit school to maintain any of these standards shall be grounds for suspension or revocation of approval. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(d) and 25686, Health and Safety Code. s 30424. Limited Permit X-Ray Technician Schools Teaching the Chest, Extremities, Gastrointestinal, Genitourinary, Leg-Podiatric, Skull, or Torso-Skeletal Categories. (a) An applicant for approval as a Limited Permit X-ray Technician School teaching chest, extremities, gastrointestinal, genitourinary, leg-podiatric, skull, or torso-skeletal categories shall require that each student who graduates from the school complete, for each limited permit category, the following course of study, within 24 months of beginning the course of study, and the supervised clinical education within one consecutive period of 12 months during that 24 month period: (1) One hundred (100) hours of formal classroom education for each limited permit category, which shall include the following: Subject Hours of Instruction (A) Radiation protection and safety.... 30 (B) Radiological physics............... 15 (C) X-ray technical factors............ 15 (D) Equipment operation and care....... 10 (E) Darkroom and film processing....... 10 (F) Medical terminology................ 5 (G) Medical ethics..................... 1 (H) Nursing procedures................. 4 (I) Film critique...................... 5 (J) Anatomy and physiology............. 5 (2) For each category, the following hours of specialized classroom instruction in anatomy and physiology, and positioning: Category Hours of Instruction (A) Chest............... 10 (B) Extremities......... 20 (C) Gastrointestinal.... 20 (D) Genitourinary....... 10 (E) Leg-podiatric....... 10 (F) Skull............... 30 (G) Torso-skeletal...... 30 (3) Fifteen (15) hours of radiation protection laboratory during which each student shall conduct experiments that demonstrate: (A) Methods of reducing dose per exposure to patient. (B) Methods of reducing dose to personnel. (4) Ten (10) hours of general radiographic laboratory during which each student shall conduct experiments that demonstrate: (A) Effects of kilovoltage, milliamperage, filtration, distance, and heel effect on radiographic contrast and detail. (B) Control of scatter. (C) Quality control. (5) Supervised clinical education for each category during which each student shall perform or assist in the performance of the following number of radiographic procedures: Category Number of Procedures (A) Chest............... 100 (B) Extremities......... 100 (C) Gastrointestinal.... 100 (D) Genitourinary....... 100 (E) Leg-podiatric....... 50 (F) Skull............... 100 (G) Torso-skeletal...... 200 Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code. s 30425. Limited Permit X-Ray Technician Schools Teaching the Dental Laboratory Category. (a) An applicant for approval as a limited permit X-ray technician school teaching the Dental Laboratory category shall require that each student who graduates from the school complete the following course of study within 24 months of beginning the course of study, and the supervised clinical education within one consecutive period of 12 months during that 24 month period: (1) One hundred and twenty (120) hours of formal classroom education, extending over a period of no less than six months, which shall include the following: Subject Hours of Instruction (A) Radiation protection and safety................. 30 (B) Radiological physics............................ 15 (C) X-ray technical factors......................... 15 (D) Equipment operation and care.................... 10 (E) Darkroom, dental and medical film processing.... 10 (F) Professional ethics and hygienic procedures..... 4 (G) Cephalometrics.................................. 16 (H) Terminology..................................... 5 (I) Film critique................................... 5 (J) Computers and image formation................... 10 (2) Forty-five (45) hours of specialized instruction in: Subject Hours of Instruction (A) Intra-oral anatomy and physiology, and positioning.... 20 (B) Extra-oral anatomy and physiology, and positioning.... 20 (C) Anatomy of the hand and wrist, and positioning for dental bone age determination............................. 5 (3) Twenty-five (25) hours of laboratory during which each student shall perform experiments using phantoms that demonstrate: (A) Methods of reducing dose per exposure to the patient and operator. (B) Effects of kilovoltage, milliamperage, filtration and distance on radiographic contrast and detail. (C) Quality control. (4) Supervised clinical education during which each student shall perform or assist in the performance of the following number of radiographic procedures: Procedures Minimum Number (A) Peri-apical survey (consisting of at least 14 films).... 100 (B) Bitewing survey (consisting of at least four films)..... 50 (C) Occlusal, mandible and maxilla.......................... 50 (D) Cephalometrics.......................................... 100 (E) Mandible, lateral view.................................. 50 (F) Panographic............................................. 50 (G) Temporo-mandibular joints............................... 20 (H) Dental bone age studies................................. 20 Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code. s 30426. Photofluorographic Chest X-Ray Technician Courses of Study. Note: Authority cited: Section 114870(a), Health and Safety Code. Reference: Sections 114870(c), 114870(d) and 107045, Health and Safety Code. s 30427. Limited Permit X-Ray Technician Schools Teaching the Dermatology X-Ray Therapy Category. An applicant for approval as a limited permit X-ray technician school teaching the dermatology X-ray therapy category shall require that each student who graduates from the school complete the following course of study within 12 months of beginning the course of study: (a) Thirty hours (30) of formal classroom education, which shall include the following: Subject Hours of Instruction (1) Radiation protection and safety......... 5 (2) Biological effects of radiation......... 5 (3) Radiological physics and equipment...... 10 (4) Structure and function of the skin...... 2 (5) Application of X-rays to dermatology.... 8 (b) Supervised clinical education during which each student shall assist or perform procedures on at least the following malignancies: Basal cell carcinoma, squamous carcinoma, and mycosis fungoides. Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code. s 30427.2. Limited Permit X-Ray Technician Schools Teaching the X-Ray Bone Densitometry Category. An applicant for approval as a limited permit X-ray technician school teaching the X-ray bone densitometry category shall require that each student who graduates from the school complete the following course of study within 12 months of beginning the course of study: (a) Eighteen (18) hours of formal classroom education consisting of the following: Subject Hours of Instruction (1) Radiation physics, biology, and protection.... 3 (2) Bone biology, bone disease and therapy, and densitometry parameters........................... 3 (3) X-ray bone densitometry equipment.............. 4 (4) Computers and image formation.................. 3 (5) Anatomy and positioning........................ 4 (6) Ethics and patient handling.................... 1 (b) Four (4) hours of laboratory training during which each student shall perform experiments using phantoms and evaluate images. (c) Supervised clinical education during which each student shall perform the following number of radiographic procedures: Procedure Number (1) Posterior/Anterior spine.... 5 (2) Hip......................... 5 (3) Extremity................... 10 Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code. s 30428. Approval of On-the-Job Training. (a) In order to be approved by the Department as an on-the-job training program, the supervisor and operator and the prospective student of radiologic technology shall submit to the Department an application for each limited permit category on forms furnished by the Department. (b) The application for approval shall include a training schedule for each limited permit category applied for. (c) The standards for approval of on-the-job training programs shall be those standards required of approved schools for limited permits as outlined in Sections 30424 and 30425 or for limited permit courses of study as outlined in Section 30427. (d) Limited permit categories for on-the-job training programs shall be restricted to the categories listed in Section 30442. (e) Each approved on-the-job training program shall meet and maintain all applicable standards set forth in this section and in Sections 30424, 30425 and 30427. Failure of an applicant to meet the applicable standards shall be grounds for denial of approval. Failure of an approved on-the-job training program to maintain any of the applicable standards shall be grounds for suspension or revocation of approval. Note: Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114875, Health and Safety Code. s 30435. Notification Requirements. Within 30 days after any of the following, an official of an approved school, course of study, or on-the-job training program shall, on forms furnished by the Department, inform the Department of: (a) Change in facility location or telephone number. (b) Change in course offerings. (c) Change of program director or faculty. (d) Change of affiliation agreements. (e) Names and addresses of students who have been dismissed, suspended or who have voluntarily withdrawn from the clinical education. (f) Names and addresses of students who have graduated. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668, Health and Safety Code. s 30436. Standards for Suspension or Revocation of Approval. (a) Approval of any school or on-the-job training program, which has been granted pursuant to section 30420 or 30428, may be revoked, suspended, limited or conditioned for any of the following reasons: (1) Violation of any provision of the Radiologic Technology Act, as defined in Health and Safety Code section 27, or any regulation promulgated pursuant thereto; or (2) If, at any time, fewer than 75% of the Department-approved examinations referenced in sections 30440, 30444, 30451 and 30455.1 and administered in the previous five years to graduates of the school have received a passing score. Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 107045, 114840, 114870(b)-(d), 114875 and 114880, Health and Safety Code. s 30437. Additional School Requirements and Recordkeeping. (a) A school approved pursuant to section 30420 shall: (1) Issue to each student who graduates or who successfully completes a required course of study, a certificate or diploma, which includes: (A) The student's name; (B) The name or the category listed in section 30442 or course of study completed by the student; (C) The date(s) of attendance; (D) The number of the certificate issued by the Department to the school; and (E) The signature of the school's chief executive officer, dean or department administrator. (2) Within 30 days of discontinuance of the school: (A) Notify the Department of how all records kept pursuant to subsection (b) will be preserved and surrender the school approval certificate to the Department; or (B) Notify the Department, transmit all records required to be kept pursuant to subsection (b) to the Department and surrender the school approval certificate to the Department. (3) Within 30 days of discontinuance of instruction in any limited permit category notify the Department. (b) Each school approved pursuant to section 30420 and each on-the-job training program approved pursuant to 30428 shall retain for at least five years: (1) Records of attendance; (2) Proof of participation in clinical education; (3) Proof of performance of laboratory procedures; (4) Certificates or diplomas issued; and (5) Program transcripts. Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 107000, 107045, 114850, 114870(c) and (d) and 114880, Health and Safety Code. s 30440. Issuance of Certificates. To obtain a radiologic technology certificate an applicant shall have on file with the Department an application as described in Section 30441, and in addition: (a) For the diagnostic radiologic technology certificate, shall pass Department-approved examinations in: (1) Diagnostic radiation protection and safety, and (2) Diagnostic radiologic technology. (b) For the therapeutic radiologic technology certificate, shall pass Department-approved examinations in: (1) Therapeutic radiation protection and safety, and (2) Therapeutic radiologic technology. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(b) and 25677, Health and Safety Code. s 30441. Acceptable Applications. The Department considers an application for a radiologic technologist certificate acceptable if all of the following conditions have been met: (a) Application is made on forms furnished by the Department. (b) Fee is paid pursuant to Section 30408. (c) Appropriate radiologic technologist school graduation diploma or certificate is submitted. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25675, Health and Safety Code. s 30442. Categories. The categories for limited permits are: (a) Chest radiography. (b) Dental laboratory radiography. (c) Dermatology X-ray therapy. (d) Extremities radiography. (e) Gastrointestinal radiography. (f) Genitourinary radiography. (g) Leg-podiatric radiography. (h) Skull radiography. (i) Torso-skeletal radiography. (j) X-ray bone densitometry. Note: Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114870(c), Health and Safety Code. s 30443. Scopes. The scope of each limited permit is as follows: (a) Chest radiography permit: radiography of the heart and lungs. (b) Dental laboratory radiography permit: radiography of the intra-oral cavity, skull, and hand and wrist, for dental purposes. (c) Dermatology X-ray therapy permit: application of X-ray to human beings for the treatment of diseases and tumors of the skin. (d) Extremities radiography permit: radiography of the upper extremities, including shoulder girdle, and lower extremities, excluding pelvis. (e) Gastrointestinal radiography permit: radiography of the esophagus, stomach, small and large intestine, and biliary tract. (f) Genitourinary radiography permit: radiography of the kidneys, ureters, urinary bladder, urethra, and internal and external genitalia. (g) Leg-podiatric radiography permit: radiography of the knee, tibia and fibula, and ankle and foot. (h) Skull radiography permit: radiography of the bone and soft tissues of the skull and upper neck. (i) Torso-skeletal radiography permit: radiography of the shoulder girdle, rib cage and sternum, vertebral column, pelvis and hip joints. (j) X-ray bone densitometry permit: radiography of the total skeleton or part thereof, using X-ray bone densitometry. Note: Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114870(c), Health and Safety Code. s 30444. Issuance of Limited Permits. To obtain any of the limited permits described in Section 30442 an applicant shall fulfill all of the following conditions: (a) Have on file with the Department an application, as described in Section 30445, for each permit applied for, and (b) Pass Department approved examinations in: (1) Radiation protection and safety, for each permit category applied for, and (2) Radiologic technology, for each permit category applied for. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(c) and 25675, Health and Safety Code. s 30445. Acceptable Applications. The Department considers an application for a limited permit acceptable if all of the following conditions have been met: (a) An application is made for each permit on forms furnished by the Department. (b) Fee is paid pursuant to Section 30408. (c) For each permit requested an applicant submits any of the following: (1) A limited permit X-ray technician school graduation diploma or certificate and evidence of completion of clinical training in the limited permit category applied for. (2) A statement, signed by the supervisor and operator who provided the training, attesting that the applicant has completed Department-approved on-the-job training in the limited permit category applied for. (3) A resume showing that education, training, and clinical experience is equivalent to the limited permit X-ray technician school curriculum in the limited permit category applied for. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25675, Health and Safety Code. s 30445.1. Acceptable Applications: X-ray Bone Densitometry. All persons authorized by the Department to perform X-ray bone densitometry as of September 1, 1997, who make application for limited permit in the category of X-ray bone densitometry on or before September 1, 1998, shall be deemed to have met the requirements of sections 30444(b) and 30445(c) for the purpose of making application for a limited permit in the category of X-ray bone densitometry. Note: Authority cited: Section 114870(a), Health and Safety Code. Reference: Section 114870(c), Health and Safety Code. s 30446. Title. No person other than an individual to whom the Department has issued a limited permit described in section 30442 shall use the title "X-ray Technician" or "XT." Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Section 106990, Health and Safety Code. s 30447. Restrictions. (a) Limited permits issued pursuant to section 30444 exclude authorization to: (1) Operate fluoroscopy equipment during exposure of a patient to X-rays. (2) Operate portable or mobile X-ray equipment. (3) Perform procedures involving computerized tomography. (4) Perform mammography procedures. (5) Perform vascular procedures. (6) Perform procedures involving scanned projection radiography (digital radiography or digital tomography), or digital fluorography. (b) Exclusions listed in subsections (a)(2) and (a)(6) shall not apply to individuals who possess a current and valid limited permit in X-ray Bone Densitometry, issued pursuant to section 30444. (c) The exclusions listed in subsection (a)(6) shall not apply to individuals who possess a current and valid limited permit in Dental Laboratory Radiography, issued pursuant to section 30444. Note: Authority cited: Sections 100275 and 114870(a), Health and Safety Code. Reference: Sections 106965, 106975, 114845, 114850, 114870(c), 114875 and 114880, Health and Safety Code. s 30450. Permit Requirement. A radiologic technologist fluoroscopy permit issued by the Department shall be required of any technologist who exposes a patient to X-rays in a fluoroscopy mode, or who does one or more of the following during fluoroscopy of a patient: (a) Positions the patient. (b) Positions the fluoroscopy equipment. (c) Selects exposure factors. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(c) and 25675, Health and Safety Code. s 30451. Issuance of Technologist Fluoroscopy Permits. To obtain a radiologic technologist fluoroscopy permit an applicant shall fulfill all of the following: (a) File with the Department an application as described in Section 30452, and (b) Pass Department-approved examinations in: (1) Fluoroscopy radiation protection and safety, and (2) Use of fluoroscopy and ancillary equipment. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Sections 25668(c) and 25675, Health and Safety Code. s 30452. Acceptable Applications. The Department considers an application for a radiologic technologist fluoroscopy permit acceptable if all of the following conditions have been met: (a) Application is made on forms furnished by the Department. (b) Fee is paid pursuant to Section 30408. (c) The technologist submits one of the following: (1) A copy of technologist fluoroscopy school graduation diploma or certificate. (2) A resume showing that education, training and experience is equivalent to that of the radiologic technologist fluoroscopy school curriculum as specified in Section 30423. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25675, Health and Safety Code. s 30455.1. Issuance of a Mammographic Radiologic Technology Certificate. (a) To obtain a Mammographic Radiologic Technology Certificate an applicant shall hold a valid and current Diagnostic Radiologic Technology Certificate issued pursuant to Section 30440(a) and shall comply with all of the following: (1) File with the Department a complete application on the Department form entitled "Application for a Certificate in Radiologic Technology", Form DHS 8200 (6/96); (2) Submit a fee pursuant to Section 30408; (3) Submit evidence of having been awarded a mammographic radiologic technology school graduation diploma or certificate; and (4) Pass a Department examination in mammography technology, including radiation protection and mammography quality assurance. (b) The following may be substituted for the requirement in subsection (a)(3) with respect to applications filed prior to July 1, 2000: (1) Advanced certification in mammography issued to the applicant by the American Registry of Radiologic Technologists; or (2) Evidence of having completed 40 hours of continuing education in mammography courses. Note: Authority cited: Sections 100275 and 114870, Health and Safety Code. Reference: Sections 114840, 114845 and 114870, Health and Safety Code. s 30460. Licentiate Certificate. The certificate category for licentiates of the healing arts is: Radiology supervisor and operator. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code. s 30461. Licentiate Permits. The permit categories for licentiates of the healing arts are: (a) Fluoroscopy supervisor and operator. (b) Radiography supervisor and operator. (c) Dermatology supervisor and operator. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code. s 30462. Radiology Certificate. A radiology supervisor and operator certificate issued by the Department shall be required of any licentiate of the healing arts who practices as a radiologist. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code. s 30463. Fluoroscopy Permits. A fluoroscopy supervisor and operator permit issued by the Department shall be required of any licentiate of the healing arts who does one or more of the following: (a) Actuates or energizes fluoroscopy equipment. (b) Directly controls radiation exposure to the patient during fluoroscopy procedures. (c) Supervises one or more persons who hold radiologic technologist fluoroscopy permits pursuant to Section 30451. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code. s 30464. Radiography Permits. A radiography supervisor and operator permit issued by the Department shall be required of any licentiate of the healing arts who does one or more of the following: (a) Actuates or energizes radiography X-ray equipment. (b) Supervises one or more persons who hold radiologic technologist certificates pursuant to Section 30440(a). (c) Supervises one or more persons who hold limited permits pursuant to Section 30444. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code. s 30465. Dermatology Permits. A dermatology supervisor and operator permit issued by the Department shall be required of any licentiate of the healing arts who practices dermatology and who uses X-ray therapy equipment for the treatment of diseases and tumors of the skin. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code. s 30466. Issuance of Licentiate Certificates or Permits. To obtain a licentiate certificate or any licentiate permit an applicant shall have on file with the Department an application as described in Section 30468, and in addition: (a) For obtaining a fluoroscopy supervisor and operator permit, shall pass a Department approved examination in fluoroscopy radiation protection and safety, and use and supervision of use of fluoroscopy and ancillary equipment. (b) For obtaining a radiography supervisor and operator permit, shall pass a Department approved examination in radiography radiation protection and safety, and use and supervision of use of radiography and ancillary equipment. (c) For obtaining a dermatology supervisor and operator permit, shall pass a Department approved examination in dermatology radiation protection and safety, and application and supervision of application of X-rays for treating diseases and tumors of the skin. (d) For obtaining a radiology supervisor and operator certificate, shall pass examinations specified in subsections (a) and (b) of this section, unless qualified for a certificate pursuant to Section 30467. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code. s 30467. Certification of Qualified Licentiates. An applicant who is certified by the American Board of Radiology or the American Osteopathic Board of Radiology, upon submission of an application, fee and documentary evidence of board certification, shall be issued a radiology supervisor and operator certificate. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25699.1, Health and Safety Code. s 30468. Acceptable Applications. The Department considers an application for a licentiate certificate or permit acceptable if: (a) Application is made on forms furnished by the Department. (b) Fee is paid pursuant to Section 30408, and (c) Evidence is provided that the applicant has one of the following valid California healing arts licenses: (1) Physician and surgeon. (2) Osteopathic physician and surgeon. (3) Podiatrist. (4) Chiropractor. Note: Authority cited: Section 25668(a), Health and Safety Code. Reference: Section 25668(e), Health and Safety Code. s 30470. Low-Level Radioactive Waste Disposal. The regulations governing low-level radioactive waste in the U.S. Government Code of Federal Regulations (CFR), Title 10, Code of Federal Regulations Part 61, as published in the Federal Register on June 22, 1993 (58 Fed. Reg. 33886) are hereby adopted by reference with the following exceptions: (a) The Department of Health Services shall be substituted in all cases where Commission, Office of Nuclear Material Safety and Safeguards or U.S. Nuclear Regulatory Commission are cited and the Department of Industrial Relations shall be substituted in all cases where the U.S. Department of Labor is cited. (b) The following sections are deleted: 61.4, 61.5, 61.8, 61.23(i), 61.23(j). Note: Authority cited: Sections 100275, 115010, 115230 and 115235, Health and Safety Code. Reference: Section 115010, Health and Safety Code. s 30471. Transfer for Disposal, Manifests and Record Keeping. The regulations governing the transfer of radioactive materials and manifests in Title 10, Code of Federal Regulations, Parts 20.2006, 61.12(n), 61.80(f) and (l), as published in the March 27, 1995 Federal Register (60 Fed. Reg. 15649) are hereby incorporated by reference. Note: Authority cited: Sections 100275, 115010, 115230 and 115235, Health and Safety Code. Reference: Section 115010, Health and Safety Code. s 30473. Definitions. (a) "Debt" means the obligations of the licensee or the named owner thereof which are fixed as to amount and which give the obligee rights as to assets of the licensee or any portion thereof which are superior to the rights of the licensee. (b) "Equity" means the total book value of tangible and intangible assets which exceeds the amount of debt. (c) "Letter of Acceptance" means a confirmation by the applicant that it agrees to be the license designee and commits itself to perform in accordance with statements, representations and procedures contained in its application. (d) "Reasonable cost" means a cost which is reasonable if, in its nature or amount, does not exceed that which would be incurred by a prudent person under the circumstances prevailing at the time the decision was made to incur the cost. Note: Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code. s 30475. Proprietary Documents. All documents submitted pursuant to the instructions in this group which are proprietary, private or confidential shall be so identified by the applying license designee or licensee as appropriate. Note: Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code. s 30477. Application for Selection as License Designee. (a) Application for designation shall be made to the Department and shall be accompanied by a filing fee of ten thousand dollars. (b) The application for designation shall contain all of the following: (1) The information described in Title 10, Code of Federal Regulations, Part 61.11 and 61.12, as published in the December 28, 1982 Federal Register (Vol. 27, No. 248), except 61.11(c)(1), (2) and (3) and 61.12(a), (h) and (i). (2) A description of any limitation in the site design which would restrict the receipt for disposal of low-level waste due to radiation levels, waste form, waste class or waste packaging. (3) A description of the natural and demographic characteristics which will be emphasized in selection of the disposal site, including geologic, hydrologic, meteorologic, climatologic and biotic features of the disposal site and vicinity. (4) A plan for community involvement in the site selection and development process, including brief descriptions of the applicant's experience with waste disposal or other developments requiring community involvement. (5) The financial information called for in Title 10, Code of Federal Regulations, Parts 61.15, 61.61, 61.62, 61.63, as published in the December 28, 1982 Federal Register (Vol. 27, No. 248); a description of the sources of financing, the terms of financing; the filing of a financial pro forma; and revenue documentation. (6) An estimate in 1984 dollars of the charges to be levied on waste received for disposal. The estimate shall assume the following: (A) A preoperational period of five years, commencing in August 1984. (B) An operating period of 20 years. (C) A closure period of five years. (D) Administrative controls extending for 100 years following the operating period. (E) A site capacity of 250,000 cubic meters. (F) A waste mix as described for Region 4 in Table D.9 "Untreated" Waste Volumes Projected to be Generated to the Year 2000 per Region (m <>3), U.S. Nuclear Regulatory Commission, Draft Environmental Impact Statement on 10 CFR Part 61 NUREG-0782, Volume 3, September 1981. Note: Authority cited: Sections 208, 25812.5(c) and 25812.5(e), Health and Safety Code. Reference: Sections 25812.5(c) and (e), Health and Safety Code. s 30479. Standards for Selecting the License Designee. (a) The applicants shall be ranked in accordance with the degree to which their application demonstrates their ability to: (1) Meet the financial standards and qualifications by reason of training, experience and character to carry out the disposal operations; (2) Provide the best concept for site development and operation as required by Title 10, Code of Federal Regulations, Part 61.23, as published in the December 28, 1982 Federal Register (Vol. 27, No. 248) except that information which would pertain only to a specific site; (3) Present an effective program to deal with concerns of the public regarding establishment of a low-level radioactive waste disposal site; and (4) Establish, based on estimates, a reasonable schedule of charges for disposal of low-level radioactive waste. Note: Authority cited: Sections 208 and 25812.5(c), Health and Safety Code. Reference: Section 25812.5(c), Health and Safety Code. s 30481. Acceptance by License Designee. (a) The applicant ranked highest pursuant to Section 30479 shall, within five days of notification of its ranking, either: (1) File a letter of acceptance, post a performance bond of one million dollars in favor of the Department and pay the annual license fee; or (2) File a letter withdrawing their application. (b) In the event that the highest ranked applicant withdraws its application, the next highest ranked applicant shall follow the processes set forth in Section 30481(a). Note: Authority cited: Sections 208 and 25812.5(c), Health and Safety Code. Reference: Section 25812.5(c), Health and Safety Code. s 30483. Standards for Forfeiture of the Performance Bond. (a) The performance bond posted pursuant to Section 30481 shall be forfeited upon: (1) Declaration of insolvency or voluntary reorganization under the bankruptcy laws, or (2) Failure to maintain the promised schedule and such failure is not the result of an act of God or Departmentally caused delay and the license designee cannot provide assurance that this delay will be remedied without jeopardizing the overall project schedule. (3) Failure to comply with requirements of this group, or (4) Failure to pay the performance bond premium 30 days prior to its expiration. (b) Upon the issuance of the operating license the licensee shall be relieved of its obligation to maintain the performance bond. Note: Authority cited: Sections 208 and 25812.5(f), Health and Safety Code. Reference: Section 25812.5(f), Health and Safety Code. s 30485. License Fee. The license designee or the licensee shall pay an annual license fee of two-hundred fifty thousand dollars. Note: Authority cited: Sections 208 and 25812(d), Health and Safety Code. Reference: Section 25812(d), Health and Safety Code. s 30487. Additional Licensee Requirements and Financial Assurances. (a) The licensee shall retain a certified public accounting firm approved by the Department for the purpose of making reports and audits of the operation of the low-level radioactive waste disposal site. (b) An unqualified audit statement shall be prepared annually with respect to all matters which bear upon the license designee's or the licensee's ability to operate pursuant to the Letter of Acceptance or license. The unqualified annual audited statement shall be submitted to the Department no later than three months after the end of the license designee's or licensee's fiscal year in each year following the filing of the Letter of Acceptance, or issuance of the license. (c) No security interest in the site shall be executed by the licensee without the consent of the Department which would give a creditor any right to stop the operation of the site. Note: Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code. s 30489. Funding for Disposal Site Closure and Stabilization. (a) Funding for the approved plan for closure and stabilization shall be obtained from a closure surcharge of ten percent of the disposal charges levied by the licensee on disposers of low-level radioactive waste. (b) The surcharge shall be deposited, within thirty days following collection, with a trustee approved by the Department, in a fund which shall be known as the Low-Level Radioactive Waste Disposal Site Closure Trust Fund. All balances in the fund shall be invested by the trustee in accordance with the investment standards set forth in Government Code, Section 16408.2. (c) The amount of the financial assurance mechanism, Title 10, Code of Federal Regulations, Part 61.62, as published in the December 28, 1982 Federal Register (Vol. 27, No. 248), shall change as necessary to take into account both the increased costs of closure and the available balance in the Low-Level Radioactive Waste Disposal Site Closure Trust Fund. Changes in costs caused by inflation shall be calculated using an inflation factor derived from the annual Implicit Price Deflator for Gross National Product as published by the U.S. Department of Commerce in its Survey of Current Business. The inflation factor is calculated by dividing the latest published annual Deflator by the Deflator for the previous year. (d) Payment for site closure and stabilization shall be made from the Low-Level Radioactive Waste Disposal Site Closure Trust Fund. Upon filing a petition to close, a licensee or any other person authorized to perform closure shall request payment for closure expenditures by submitting itemized bills to the trustee. The trustee is authorized to pay those bills which the trustee finds to be in accord with the approved plan and shall make reports of the expenditures to the Department quarterly in the first 12 months of closure and annually thereafter. Note: Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code. s 30491. Liability Insurance. The licensee shall carry nuclear liability insurance of no less than ten million dollars for both sudden and accidental or slow and gradual contamination to people or property off site. Note: Authority cited: Sections 208 and 25812(b), Health and Safety Code. Reference: Section 25812(b), Health and Safety Code. s 30493. Establishment and Approval of Rates. (a) The licensee shall establish a schedule of rates for waste disposal subject to approval by the Department. (b) The rates for disposing of waste shall remain in effect for no less than two years from the effective date of the rates and shall be subject to review by the Department biennially. (c) Any proposal to establish or change disposal rates shall be made to the Department by the licensee or a waste generator. Note: Authority cited: Sections 208 and 25812.7, Health and Safety Code. Reference: Section 25812.7, Health and Safety Code. s 30495. Calculation of the Rate Schedule. (a) The rate schedule shall be determined by dividing the total rate base, as calculated pursuant to Section 30495(c), by the sum of the estimated or actual amounts of all classes of waste received. (b) Twenty-two months following establishment of the rate schedule, the licensee shall furnish the Department with the actual monthly disposal volumes by class compared with those assumed for that year. (c) The rate base shall be calculated by analyzing the following components: (1) Amortization on a straight-line basis, over a 20 year operating period, of costs incurred prior to the start of site operations. Costs shall include: (A) Site acquisition costs, including but not limited to acquiring the land for the low-level radioactive disposal site and deeding the land to the State; (B) Licensing costs, including but not limited to the costs associated with initial site selection, and the development of any plans, reports, designs, manuals and schedules necessitated by this group; (C) Site development costs, including but not limited to grading, development of roads, installation of fencing and lighting, or installation of a system of wells and air monitors; (D) Administrative costs, incurred during the time between approval of the Letter of Acceptance and licensure that have not been included in prior items. (2) Depreciation on a twenty year straight-line basis of all buildings and equipment used in the operation of the disposal site and not including those costs specified in Section 30495(c)(1). (3) Site operating costs consisting of those necessary and reasonable costs incurred during the daily operations of the disposal site. (A) Costs applicable to services, facilities, equipment or supplies furnished to the licensee by organizations related to the licensee by common ownership or control are includable as site operating costs for the purpose of rate determination at the actual cost to the related organization. (B) Fines or penalties are not includable as site operating costs in the rate base. (4) The actual interest costs for any necessary short-term or long-term debt provided that the borrowed funds were devoted to the disposal site. (5) A return factor specified by the licensee. Note: Authority cited: Sections 208 and 25812.7, Health and Safety Code. Reference: Section 25812.7, Health and Safety Code. s 30497. Rate Review Documentation. (a) For the purpose of verifying the rate base upon which rates have been proposed or established, including any rate base changes affecting the calculating of proposed rates, the licensee shall supply the following reports: (1) Semiannual reports of all costs specified in Section 30495(c) incurred prior to the issuance of the license. (2) An annual financial report which includes data used or proposed to be used by the licensee in the calculation of the rate base and/or rates for disposal of waste. This report shall be due within three (3) months of the licensee's fiscal year. (3) The books and records supporting the reports referred to in this section shall be maintained in a form capable of and subject to review and audit by the Department. (4) All contracts made by the licensee which require payments by the licensee of five percent or more of the latest annual reported gross revenue shall require that an independent audit report be made available to the Department. Note: Authority cited: Sections 208 and 25812.7, Health and Safety Code. Reference: Section 25812.7, Health and Safety Code. s 30499. Adjustment of Rate Schedule. If the actual volumes differ by five percent or more from the estimated total for the twenty-two month period, the rates shall be adjusted on the biennial review date to reflect the over- or under-estimation. Note: Authority cited: Sections 208 and 25812.7, Health and Safety Code. Reference: Section 25812.7, Health and Safety Code. s 30500. Certified Technologist, Nuclear Medicine. "Certified technologist, nuclear medicine" means a person who holds a current certificate issued pursuant to Section 30532. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Government Code. s 30501. Direct Supervision. "Direct supervision" means that the supervisor is physically present in the same room with the certified technologist, nuclear medicine, special permit holder or student of nuclear medicine technology at the time the nuclear medicine technology procedure is being performed. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30502. General Supervision. (a) "General Supervision" means that the supervisor is responsible for, and has control of, all of the following: (1) Quality, technical and medical aspects of all nuclear medicine technology procedures. (2) Radiation health and safety of patients, ancillary personnel and other persons. (3) Ascertaining that certified technologists, nuclear medicine, maintain their competency by participation in management-sponsored or formal continuing education or training offered by professional organizations or societies, or by institutions of higher learning. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30503. In Vitro Test. "In vitro test" means a nuclear medicine technology procedure in which the radioactive material is not administered to a human being. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 25625 and 25626, Health and Safety Code. s 30504. In Vivo Test. "In vivo test" means a nuclear medicine technology procedure in which the radioactive material is administered to a human being. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 25625 and 25626, Health and Safety Code. s 30505. Licensed Clinical Bioanalyst. "Licensed clinical bioanalyst" means a person who holds a current license issued pursuant to Section 1260 of the California Business and Professions Code to practice clinical laboratory bioanalysis. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code; and Section 1260, Business and Professions Code. s 30506. Nuclear Medicine Physician. "Nuclear medicine physician" means a physician and surgeon who is authorized by a specific radioactive material license issued pursuant to Section 30195 of this title to use radioactive material for diagnosis and treatment of disease in human beings. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30507. Nuclear Medicine Technology Procedures. (a) "Nuclear medicine technology procedure" means procedures utilizing radioactive material for the diagnosis and treatment of disease in human beings, and include, but are not limited to, one or more of the following: (1) Administration of radioactive material to human beings for diagnostic purposes. (2) Withdrawal of blood samples for an in vitro test. (3) Oral administration of radioactive material to human beings for therapeutic purposes. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 25625 and 25626, Health and Safety Code. s 30508. Special Permit. "Special permit" means a permit issued pursuant to Section 30541. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30509. Student of Nuclear Medicine Technology. "Student of nuclear medicine technology" means a person who has started and is in good standing in a course of instruction which, if successfully completed, would permit the person to receive a certificate in nuclear medicine technology issued pursuant to Section 30532. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30510. Supervisor. "Supervisor" means a nuclear medicine physician, or, when performing in vitro tests, a physician and surgeon or a licensed clinical bioanalyst. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 25625 and 25626, Health and Safety Code. s 30520. Competency Criteria. (a) To meet the competency criteria for basic education in nuclear medicine technology, an applicant shall have successfully completed college level instruction in at least the following: (1) Human anatomy and physiology. (2) Physics. (3) Mathematics (4) Medical terminology. (5) Oral and written communications. (6) General chemistry. (7) Medical ethics. (8) Methods of patient care. (9) Radiation safety and protection. (10) Nuclear medicine physics. (11) Radiation physics. (12) Nuclear instrumentation. (13) Statistics. (14) Radionuclide chemistry. (15) Radiopharmacology. (16) Department organization and function. (17) Radiation biology. (18) Nuclear medicine in vivo and in vitro tests. (19) Radionuclide therapy. (20) Computer applications. (b) To meet the competency criteria for laboratory instruction in nuclear medicine technology, an applicant shall have successfully completed college level instruction and training in at least the following: (1) Collimators -sensitivity versus resolution. (2) Survey instruments -composition, function, calibration and use. (3) Gamma ray spectrometry -composition, function and use. (4) Nuclear generators and dose calibration. (5) Preparation of radioactive material for nuclear medicine technology procedures. (6) Radioactive material waste handling techniques. (c) To meet the competency criteria for clinical experience in nuclear medicine technology, an applicant shall have successfully performed at least all of the following: (1) Fifty in vitro tests. (2) Participation in ten oral administrations of radioactive material to human beings for therapeutic purposes. (3) Ten of each of the following nuclear medicine technology procedures. (A) Brain imaging and cisternography. (B) Bone imaging. (C) Thyroid imaging. (D) Cardiac imaging. (E) Pulmonary imaging. (F) Gastrointestinal imaging. (G) Genitourinary imaging. (H) Great vessel imaging. (I) Tumor and abscess imaging. (4) Ten of each of the following in vivo tests: (A) Thyroid uptake. (B) Blood volume. (C) Schilling test (B-12). (5) Ten administrations of radioactive material to human beings for the purpose of performing nuclear medicine technology procedures after having received instruction in all of the following: (A) Pertinent anatomy and physiology of all possible venipuncture sites. (B) Choice of instruments, intravenous solutions, and equipment. (C) Proper puncture techniques. (D) Techniques of intravenous line establishment. (E) Hazards and complications of venipuncture. (F) Post-puncture care. (G) Composition and purpose of antianaphylaxis tray. (H) First aid and instruction in basic cardiopulmonary resuscitation. (I) Care of specimen. (6) Ten withdrawals of blood samples for in vitro tests. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30521. Supervision Requirements. (a) Certified technologists, nuclear medicine, special permit holders, and students of nuclear medicine technology shall be under: (1) General supervision when performing nuclear medicine technology procedures. (2) Direct supervision when performing oral administration of radioactive material to human beings for therapeutic purposes. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30530. Acceptable Applications. (a) The Department considers an application for a certificate in nuclear medicine technology acceptable if all of the following conditions have been met: (1) Application is made on a Nuclear Medicine Technology Certificate Application form DHS 8435 (7/87) furnished by the Department. (2) Fee is paid pursuant to Section 30535. (3) Documentation provided with the application establishes that the applicant's basic education, laboratory instruction and clinical experience meet at least the competency criteria set forth in Section 30520. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30531. Application Process and Deadlines. (a) Submission of an application, documents, information, or fees supporting the application for any certificate or special permit issued under this subchapter shall be deemed to occur on the date the application, documents, information, or fees are received by the Department. (1) An application is considered complete when all documents, information, or fees required to be submitted on or with the application have been received by the Department, and the applicant has passed any required examination. (2) Written notification by the Department to applicants shall be deemed to occur on the date the notification is postmarked. (b) The Department shall notify the applicant, within 30 calendar days of submission of the application for any certificate or special permit issued under this subchapter, of one of the following: (1) That the application is complete and the Department's decision regarding the application. (2) That the application is not accepted for filing and what specific documents, information, or fees the applicant shall submit within 30 calendar days in order for the Department to consider the application acceptable. (3) That the application is acceptable and what examination the applicant shall pass in order to complete the application. (c) The Department shall notify the applicant, within 60 calendar days of the date of any examination required by subsection (b)(3) of the results of the examination. (d) The Department shall deem an application for a certificate or special permit issued under this subchapter to have been withdrawn by the applicant who fails to: (1) Within 30 calendar days of notification, pursuant to subsection (b), respond to the Department's request to submit specific documentation, information, or fees; or (2) Within 180 calendar days of notification pursuant to subsection (b), pass any required examination. (e) Any applicant deemed by the Department to have withdrawn an application pursuant to subsection (d) may reapply by submitting a new application. (f) The Department's time periods for processing an application, from the date the initial application is received by the Department to the date the application is complete and the final decision is made regarding a certificate or special permit issued under this subchapter are as follows: (1) The median time for processing an application is 90 calendar days. (2) The minimum time for processing an application is one day. (3) The maximum time for processing an application is 240 calendar days. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 15376, Government Code; and Section 25626, Health and Safety Code. s 30532. Issuance of Certificates. (a) To obtain a certificate in nuclear medicine technology an applicant shall have on file with the Department an acceptable application as described in Section 30530, and (1) Pass an examination in nuclear medicine technology administered by the Department, or (2) Submit documentary evidence of having passed an examination equivalent to that administered by the Department and offered by one of the following: (A) Nuclear Medicine Technology Certification Board. (B) American Registry of Radiologic Technologists. (C) American Society of Clinical Pathologists. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30533. Scopes of Certificates. (a) Certificates shall be issued for one or more of the following: (1) Diagnostic in vivo and in vitro tests involving measurement of uptake, dilution, or excretion, including venipuncture, but not involving imaging. (2) Diagnostic nuclear medicine technology procedures involving imaging, including venipuncture. (3) Use of generators and reagent kits for preparation of radioactive material. (4) Internal radioactive material therapy. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30534. Title. No person other than individuals to whom the Department has issued a certificate in nuclear medicine technology shall use the title "Certified Technologist, Nuclear Medicine" or "CTNM." Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 25626, 25629 and 25631, Health and Safety Code. s 30535. Fees. (a) Each individual applying for a certificate in nuclear medicine technology shall pay an application fee of $153.00. (b) Each individual applying for a special permit in nuclear medicine technology shall pay an application fee of $183.00. (c) Each individual repeating a failed examination shall pay a fee of $75.00 per examination. (d) The fee for replacement of a certificate in nuclear medicine technology shall be $12.00. (e) Each individual applying for renewal of a certificate in nuclear medicine technology shall pay a renewal application fee of $175.00. (f) Any individual who fails to pay the renewal application fee by the expiration date of the certificate shall immediately cease performance of duties requiring a certificate in nuclear medicine technology until such time as the fee and a late fee of 25 percent of the annual renewal application fee has been paid. (g) Fees required by this section shall be nonrefundable. Note: Authority cited: Sections 100275 and 107160, Health and Safety Code. Reference: Section 107160, Health and Safety Code. s 30536. Renewal Procedures. (a) Certificates issued pursuant to Section 30532 shall expire five years from the date of issuance. (b) Applications for renewal of each certificate shall be: (1) Made on a Nuclear Medicine Technology Certificate Renewal form DHS 8437 (4/88) furnished by the Department. (2) Accompanied by fee paid pursuant to Section 30535. (3) Filed with the Department at least 60 days prior to the expiration date of each certificate. (c) The Department considers an application for renewal of a certificate in nuclear medicine technology complete if the following conditions have been met. (1) Documentation submitted with the application establishes that the applicant has participated in management-sponsored or formal continuing education or training offered by one or more of the following: (A) Professional organizations or societies. (B) Institutions of higher learning. (2) The applicant's education and training includes at least five clock hours since the last certificate renewal or initial application in each of the scopes specified in Section 30533 for which the certificate was issued. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30537. Notification Requirements. (a) Every person who holds a current certificate issued pursuant to Section 30532 shall report to the Department any change of name or mailing address within 30 days of the change. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30540. Students of Nuclear Medicine Technology. The provisions of Section 30532 shall not apply to students of nuclear medicine technology when such students are performing nuclear medicine technology procedures under supervision as outlined in Section 30521 and are under direct guidance of an instructor who holds a current certificate issued pursuant to Section 30532. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 25626 and 25631, Health and Safety Code. s 30541. Special Permits. (a) To obtain a special permit in nuclear medicine technology, an applicant shall have on file with the Department a complete special permit application. (b) The Department considers an application for a special permit complete if all the following conditions have been met: (1) Application is made on a Nuclear Medicine Technology Special Permit Application form DHS 8436 (7/87) furnished by the Department. (2) Fee is paid pursuant to Section 30535. (3) The application is accompanied by a statement from the employer, verified by the Department, that the people in the locality in which the special permit is sought would be denied nuclear medicine technology services because of unavailability of certified technologists, nuclear medicine. (c) Special permits shall be issued for a period of time not to exceed two years and are not renewable. (d) Special permits shall not be transferable to another facility. (e) Minimum qualifications for an applicant for a special permit shall be any of the following: (1) Bachelor's degree in physical or biological sciences or equivalent, issued by an institution of higher learning. (2) Sixty semester units in physical or biological sciences or equivalent, obtained in an institution of higher learning. (3) Proof of state or national registration or certification in radiologic technology, medical technology, nursing, or respiratory technology. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25626, Health and Safety Code. s 30542. Display. Any nuclear medicine technologist who holds a current certificate issued pursuant to Section 30532 shall prominently display such certificate or photocopy thereof at each facility where the technologist is performing nuclear medicine technology procedures. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 25626 and 25631, Health and Safety Code. s 30543. Inspection. The owner, occupant, or person in charge of any private or public facility specified as a condition of a license, certificate, or special permit issued pursuant to this Subchapter shall permit any officer, employee, or designated agent of the Department to enter such property at all reasonable times for the purpose of inspecting those areas of the property where authorized nuclear medicine technology procedures are performed and determining whether or not there is compliance with or a violation of provisions specified in Sections 25625 to 25631, inclusive, of the Health and Safety Code, or of this subchapter. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 25631, Health and Safety Code. s 30550. Fuel Tank Emissions. s 30560. Carburetor Hot Soak Emissions. s 30570. Exhaust Odor and Irritation. Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 11349.7, Government Code. SUBCHAPTER 5. AIR SANITATION [FNA1] [FNa1] For regulations of Air Resource Board see Title 13, Chapter 3. s 30690. Table of Standards and Explanatory Footnotes. (a) Table of Standards "ADVERSE" LEVEL "SERIOUS" LEVEL "EMERGEMCY" Level at which there Level at which LEVEL there POLLUTANT will be sensory irritu- will be Level at which alteration of it is like- tion, duamge to vegeta- bodliy function ly that acute or sickness or tion, reduction in which is likely death in to lead to sensitive visibility or similar ef- chronic disease. groups of persons will fects. occur. ------------------------- Photochemical ) "Oxidant Footnote 1 Footnote 1 Pollutants ) Index" Not applicable Not applicable Hydrocarbons ) 0.15 ppm for 1 hour by Oxidant > the potassium iodine Footnote 2 Footnote 3 Ozone ) method (eye irriation, Not applicable not applicable Photochemical) damage to vegetation Aerosols ) and visibility reduc- tion) ------------------------- Nitrogen Dioxide 0.25 ppm for 1 hour 3 ppm for 1 Footnote 4 hour(bron- (coloration of the at choconstriction) mosphere during day- light hours) Carbon Monoxide Not applicable 30 ppm for 8 Footnote 5 hours or 120 ppm for 1 hour (in terference - with oxy- gen transport by blood Ethylene 0.5 ppm for 1 hour or Not applicable Not applicable (damage to vegetation Hydrogen Sulfide 0.1 ppm for 1 hour Footnote 6 Footnote 7 (sensory irritation) Particulate Sufficient to reduce vis- Not applicable Not applicable Matter iblity to less than 3 miles when relative hu midity is less than 70 percent Sulfur Dioxide 1 ppm for 1 hour or 0.3 5 ppm for 1 hour 10 ppm for 1 (bron-) hour (se ppm for 8 hours (dam- choconstriction) vere distress in human age to vegetation) subjects) Sulfuric Acid Footnote 8 Footnote 8 Footnot 9 Curcinogens Not applicable Footnote 10 Not applicable Hydrogen Fluoride Footnote 11 Footnote 12 Not applicalbe Lead Not applicable Footnote 13 Footnote 13 (b) Footnotes. (1) Hydrocarbons are a group of substances most of which, normally, are toxic only at concentrations in the order of several hundred parts per million. However, a number of hydrocarbons can react photochemically at very low concentrations to produce irritating and toxic substances. Because of the large number of hydrocarbons involved, the complexity of the photochemical reactions and the reactivity of other compounds such as nitrogen dioxide and ozone, it is not yet possible to establish "serious" and "emergency" levels for hydrocarbons. From the public health standpoint, the concentration of those hydrocarbons which react photochemically should be maintained at or below the level associated with the oxidant index defined in the "adverse" standard. (2) Ozone, at 1 ppm for eight hours daily for about a year has produced bronchiolitis and fibrositis in rodents. Extropolation of these data to man is difficult. Functional impairment data have been reported; at 1.25 ppm some effect is observed on residual volume and diffusing capacity. The variability of the tests was not reported. Additional data would be needed before a standard is set. (3) A value of 2.0 ppm of ozone for one hour may produce serious interference with function in health persons and the assumption is made that this might cause acute illness in sensitive persons. (4) Nitrogen dioxide, at concentrations above 2.5 ppm. causes acute damage to sensitive plants. One ppm for eight hours will produce significant growth reduction, expressed as fresh and dry weight, with no visible lesions of damage. High levels (150-220 ppm) in short exposures produce fibrotic changes in the lungs of man that may end fatally. (5) Given certain assumptions concerning ventilatory rates, acute sickness might result from a carbon monoxide level of 240 ppm for one hour in sensitive groups because of inactivation of ten percent of the body's hemoglobin. In any event it is clear that when a population exposure limit has been set for carbon monoxide, because of exposure from other sources, community air pollution standards should be based on some fraction of this limit. (6) Hydrogen sulfide is not known to produce chronic disease in humans but there may be durable sequelae from acute exposures. The disagreeable odor my interfere with appetite in sensitive groups of persons at about 5 ppm. At high concentrations loss of the sense of smell occurs. This has been reported at 100 ppm for exposure lasting two to fifteen minutes. Conjunctivitis and mild respiratory tract irritation have been reported at levels of 50-100 ppm for one hour. (7) Acute sickness and death with neurotoxicity may occur at concentrations of several hundred ppm. It is very unlikely these levels will occur in community air pollution. (8) A sulfuric acid mist level of 1 mg/M super3 with an average particle size of 1 micron will produce a respiratory response in man. It is not possible to generalize from this fro all air pollution conditions, because under natural conditions, particle size will vary. Only with large droplets would sensory irritation be produced without other physiological effects. (9) A level of 5 mg/M super3 of sulfuric acid mist for a few minutes produces coughing and irritation in normal individuals. Presumable, it could cause acute illness in sensitive groups of persons in a period of one hour. (10) Carcinogens include a few organic compounds such as some polycyclic hydrocarbons and some metals such as arsenic and chromium. Studies on effects of such substances are currently under way, but there are not sufficient data, at present, to set standards. In the meantime, it is recommended that concentrations of carcinogens in air should be kept as low as possible. (11) Hydrogen fluoride and other airborne fluorides settle upon and some are absorbed into vegetation. When forage crops containing 30-50 ppm of fluoride measured on a dry weight basis are regularly consumed over a long period the teeth and bones of cattle may show changes, depending on age, nutritional factors and the form of fluoride ingested. Such changes may or may not have any economic effect. Fluroides at these levels do not necessarily cause injury to the forage plants themselves. However, injury may be produced in certain species of vegetation upon long term exposure to low levels of atmospheric fluorides. (12) The irritating properties of hydrogen fluoride in experimental human exposure have been manifested by desquamation of the skin, at concentrations of 2-5 ppm. mucous membrane irritation also occurs from hydorgen fluorides but quantitative data are not adequate to support a standard. (13) It is clear that lead levels should be set on the basis of average values for long periods. While data are abundant concerning human response to eight-hours-a-day, five-days-a-week expsoures, data are insufficient for the effects of the continuous exposure inherent in community air pollution. While laboratory studies will be pursued with vigor, it becomes very important that local agencies collect data on existing lead levels. Since lead exposures are from multiple sources, community air pollution standards should be based ona portion of the total limit for population exposure. s 30700. Definitions. (a) Wherever the term "local enforcing agency" is used in this subchapter, it shall mean the local health officer having jurisdiction. (b) Wherever the term "State Department" is used in this subchapter, it shall mean the State Department of Public Health Services. (c) Wherever the term "food service area" is used in this subchapter, it means any area in which food is stored, prepared or served. (d) Wherever the term "tent or tent structure" is used, it shall mean any shelter of which twenty-five percent (25%) or more of the walls or roof, or both are constructed of, or covered or protected by, canvas or any other fabric material. (e) Whenever the term "intermittent short-term organized camp" is used in this subchapter, it shall mean a site, operated by a city or a county, for camping by any group of people with a program and facilities established for the primary purpose of providing an outdoor group living experience with social, spiritual, educational or recreational objectives for a period of not more than 72 consecutive hours. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30701. Limitation of Scope. The minimum standards pertaining to physical facilities set forth in this subchapter shall not apply to camping activities carried out away from a central campsite and where primitive living conditions are an inherent part of the planned activity. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30702. Campsite. The campsite, consisting of activity, living and utility areas and established trails, shall be in an area properly drained and free or protected from natural or man-made hazards, such as mine pits, quarries, and high-speed roads, or large numbers of insects and venomous snakes. Poison oak shall be controlled. Excessive dust in the central campsite shall be prevented by suitable means. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30703. Notice of Intention to Operate. (a) At least thirty (30) days prior to the operation of any existing camp in any calendar year, written notice shall be sent to the health officer of the city, county, or city and county wherein the camp is located, setting forth the name, location and mailing address of the person or agency owning the camp, the name and address of the person or agency proposing to operate the camp and the proposed dates of occupancy during that calendar year. Camps which operate year-round shall provide only an initial notice of operation. (b) Written notice shall be sent to the local health officer at least thirty (30) days prior to construction of any new camp or of any major expansion of physical facilities. (c) Health officer shall acknowledge in writing receipt of said notices and shall so notify the State Fire Marshal. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30710. Water Supply. A dependable supply of potable water adequate to furnish fifty (50) gallons of water per person per day shall be available. Where pit or chemical toilets are used, this figure may be reduced to thirty (30) gallons per person per day. The water supply system shall conform to the following: (a) Sources. (1) Wells. Water wells shall be constructed in accordance with the requirements of Chapter II and Appendices A, B, C of the Water Well Standards: State of California Bulletin 74-81 (December, 1981), published by the Department of Water Resources, State of California Resources Agency. (2) Springs. (A) Location. A spring shall not be located on the side of or at the foot of a hill if cesspools, privies, sewers, or other sources of contamination are situated where they would be above the spring and in the path of the groundwater flow toward the spring. In no case shall a spring be located closer than two hundred (200) feet to an upstream potential source of contamination. (B) Construction. Springs shall be developed with tight box or enclosure including a watertight cover with no openings that will permit entrance of surface waters, windblown dusts or small animals. (3) Streams. No stream sources shall be used without treatment. (b) Supply. Water quality, quantity, monitoring, storage, and distribution shall comply with the requirements of the California Safe Drinking Water Act, Health and Safety Code, Section 4010-4037. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Sections 4026 and 18897.2, Health and Safety Code. s 30711. Drinking Fountains. Drinking fountain shall be provided centrally located in the campsite. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30712. Hand Washing Facilities. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30713. Showers. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30714. Toilets. Toilets shall be provided at the ratio required in appendix 5C of the State Plumbing Code, Part 5, Title 24, California Administrative Code. Pit or chemical toilets shall be located so as not to endanger water supplies and shall be so constructed as to exclude flies from access to excreta. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Sections 18897.2 and 18944(a), Health and Safety Code. s 30715. Plumbing. All plumbing fixtures, equipment, piping, drainage, waste, venting and sewer systems shall conform to the plumbing code of the jurisdiction in which the organized camp is located except as provided in the State Plumbing Code, Part 5, Title 24, California Code of Regulations, and except that the local enforcing agency shall have the authority to specify other approved methods of sewage disposal. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30720. Building Structures. (a) Plans and specifications shall be approved by the local enforcing agency prior to start of any construction. (b) Every building or structure shall be designed and constructed in accordance with the building code in the jurisdiction in which the organized camp is located except as provided in the State Building Code, Part 2, Title 24, California Code of Regulations, and section 19150 of the California Health and Safety Code. (c) Every building or structure shall be inspected during its construction. Upon completion of construction, the person, firm or corporation responsible for its design, shall certify in writing to the local enforcing agency that the building or structure was, in fact, constructed in accordance with the approved plans and specifications therefor. (d) Nothing in this section shall prohibit the State Department of Health Services or local enforcing agency, from contracting with the Office of the State Architect of the Department of General Services or any private or other governmental agency for the review of design and performance of inspection of construction of camp buildings and structures, in accordance with the provisions of this section. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30721. Sleeping Accommodations. Head-to-head sleeping shall be prohibited. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30722. Repair, Safety, Maintenance and Sanitation. (a) Every building, structure, tent, tent structure, cabin, and premises shall be kept in good repair, and shall be maintained in a safe and sanitary condition, clean and free from accumulations of paper, rubbish, or standing water, satisfactory to the local enforcing agency. (b) All appliances, equipment, devices, facilities, electrical, mechanical, plumbing, refrigerating and ventilating systems shall be kept in good repair, and shall be maintained in a safe and sanitary condition satisfactory to the local enforcing agency. (c) When provided, mattresses, mattress covers, blankets, sheets, pillows, and/or sleeping bags shall be maintained sanitary and in good condition. Blankets, sheets, pillows, and/or sleeping bags shall be laundered and/or sanitized prior to issuance to a camper. Mattresses shall be covered with waterproof material or washable covers so as to be easily cleaned and sanitized. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30723. Electrical Installation. All electrical appliances, equipment, wiring and systems installed in an organized camp shall conform to the electrical code of the jurisdiction in which the organized camp is located and the Public Utilities Commission, General Order No. 95 (March 1981), Rules for Overhead Electrical Line Construction. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30724. Mechanical Installation. All mechanical equipment installed in an organized camp shall conform to the mechanical code of the jurisdiction in which the organized camp is located. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30730. Food Service Facilities. Food service facilities shall comply with the requirements of the California Uniform Retail Food Facilities Law, Health and Safety Code, Section 27500, et seq. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Sections 18897.2 and 27502, Health and Safety Code. s 30731. Light, Ventilation and Sanitary Facilities. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30732. Cleaning and Sanitizing of Multiuse Utensils. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30733. Storage of Food, Utensils and Equipment. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30734. Health Requisites for Food Service Personnel. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30734.1. Food Service Facilities and Operations at Intermittent Short-Term Organized Camps. Provisions of Section 30730 shall not apply to intermittent short-term organized camps unless food is provided or prepared by the group for camper consumption. When food is provided or prepared by the group for camper consumption, food preparation facilities shall be in compliance with the provisions of Section 30730. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30735. Garbage and Refuse. All garbage and refuse shall be deposited and stored in flytight containers, removed and disposed of at a frequency and in a manner satisfactory to the local enforcing agency. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30736. Vectors and Pests. Every camp shall have a plan and equipment for coping with excessive numbers of flies, mosquitoes and other insects and with rodents. At times or places where special risk of transmission of disease to humans from insects, rodents or other animals exists, the camp shall institute special measures to protect the campers, under the guidance of the local enforcing agency. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference cited: Section 18897.2, Health and Safety Code. s 30740. Swimming Facilities. All swimming pools, pools, wading pools and special purpose pools which are located in or provided for any organized camp shall be: (a) Designed, (b) Constructed, (c) Maintained, and (d) Operated in accordance with the provisions of Article 3, Chapter 1, Division 20, of the Health and Safety Code, Sections 24101-24109 and with the applicable provisions of Chapter 20, Division 4, Title 22, and Chapter 2-90, Part 2, Title 24, California Administrative Code. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Sections 18897.2 and 24102, Health and Safety Code. s 30741. Other Swimming and Bathing Facilities. (a) Any swimming facility or natural bathing place that is not subject to the provisions of Section 30740, and every boating facility which is located in or provided for any organized camp, shall be approved by the local enforcement agency prior to use and shall be operated and used in accordance with any special conditions that may be specified in writing by the local enforcement agency to protect health and safety. (b) Any organized camp which utilizes natural bathing places such as the seacoast, lakes or streams for swimming shall be equipped with at least one lifeboat (see Harbors and Navigation Code Section 652), which shall: (1) be used for no purpose other than for the saving of life or for other emergencies; and (2) be kept in good repair and readily accessible to the areas of potential use. (3) The lifeboat may be substituted with equivalent water safety devices that are suited to the size, location, and use of the water facility; population of the camp; dangers inherent to the water facility; and when approved by the local health officer. (c) No camp shall maintain or use a natural swimming or bathing area unless careful soundings of depth of water and location of eddies and pools and determinations of the presence and nature of dangerous currents, sunken logs, rocks and obstructions in the stream or river have been made. (d) The camp operator shall post signs indicating in plain letters, the depth of water, the location of pools or eddies, and the presence and direction of currents of water. These signs shall be visible from the natural swimming or bathing area during the season when bathing and swimming are permitted. (e) Lifeguard service as described in Section 24100.1, Health and Safety Code, shall be provided where either swimming pools or natural bathing places are used. There shall be a designated aquatics supervisor who is at least eighteen (18) years of age and who shall possess an American Red Cross Advanced Lifesaving Certificate or its equivalent certificate. Lifeguard service shall be provided at a ratio of one (1) lifeguard for each twenty-five (25) persons in the water. Note: Listed below are corresponding sections of Titles 17 and 24, California Administrative Code, pertaining to swimming facilities: T17-7774, T17-7810, T17-7833. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30750. Health Supervision. (a) Every camper and staff member entering camp shall furnish a health history and a statement of immunization and overall health status. The local enforcing agency, when necessary for the protection of the health of campers and staff members, may require special inoculations for each camper and staff member entering camp (tetanus, polio, etc.). This provision shall not apply to adult campers or those coming as family groups. (b) There shall be a full-time adult at the camp charged with health supervision, who is either a licensed medical doctor, a registered nurse, a licensed vocational nurse, or a person who has a certificate of training in the principles of first aid (Red Cross or equivalent). (c) If a physician is not on the grounds, arrangements shall be made for a physician to be available on an on-call basis. An infirmary (tentage or other shelter), with provision for isolating patients, shall be provided. Advance arrangements shall be made for the immediate removal of seriously sick or injured campers or staff members to a point of adequate medical care, on recommendation of a physician. This subsection shall not apply to intermittent short-term organized camps except when required by the local enforcing agency for the protection of the health of campers and adult supervisors. (d) A medical log book shall be maintained which includes at least the following information: Person treated; first aid or medical treatment rendered; name of the person administering the first aid or medical treatment; and the date of treatment. The medical log shall be in a bound book with sequentially numbered lined pages. A separate entry shall be made for each accident, injury or illness. (e) Every person in charge of an organized camp must report all occurrences of foodborne illness and medically diagnosed infectious, contagious or communicable diseases promptly to the local enforcing agency. (f) All camper medication brought to organized camps by minor campers or adults that is to be dispensed by organized camp personnel shall be: (1) in the original container and labeled in accordance with California Health and Safety Code, Division 21, Chapter 6, Article 3, or (2) in containers accompanied by specific written dispensing instructions by a parent, legal guardian or licensed medical doctor. (g) All medications shall be stored in a locked container when unattended by a staff member. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30751. General and Safety Supervision. (a) Every camp, at all times of operation, shall have a person in charge who is at least twenty-five (25) years of age. In addition, there shall be a competent staff, adequate for the maintenance and operation of the camp facilities. There shall be a competent staff adequate for the care, protection, and supervision of the campers. (b) There shall be at all times at least one counselor who is a high school graduate or who is at least eighteen (18) years of age, for each ten (10) campers under sixteen (16) years of age. (c) Counselors shall possess demonstrated competence to supervise safety of camp activities. All counselors shall have been trained in the principles of First Aid. (d) The organized camp site owner shall provide or ensure by contract that medical, emergency transportation facilities, lifeguard, supervisory and food service staff required by this subchapter is available when the site is in operation as an organized camp by a group or persons other than those controlled by the site owner. (e) Subsections (b) and (c) shall not apply to intermittent organized short-term camps. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30752. Transportation. (a) All camps shall provide transportation for use in emergency situations. (b) When emergency transportation does not include an on-site vehicle in good running condition, a specific plan for emergency transportation shall be maintained at the camp. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. s 30753. Emergency Procedures. (a) Each organized camp shall retain on site separate plans outlining procedures which deal with the following emergency situations: (1) Natural disasters and other emergencies. (2) Lost camper and lost swimmer. (3) Fire. (4) Transportation emergencies. (5) Severe illnesses and injuries. (6) Stranger in camp. (b) Plans shall contain at least evacuation procedures, procedures for communication with emergency medical facilities and the nearest fire station, and procedures for the control of vehicular traffic through the camp. (c) Staff shall be trained in implementation of the established emergency procedures. Note: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Reference: Section 18897.2, Health and Safety Code. Note: Authority cited: Sections 208, 3900, 3901, 15020 and 25800-25870, Health and Safety Code; Section 1224, Business and Professions Code. Reference: Sections 3900, 3901, 15000-15023 and 25811, Health and Safety Code; Sections 475, 480, 481, 482 and 1242.5, Business and Professions Code. s 30801. Standards. The wiping rags or materials to be processed and used as wiping rags shall be washed using an effective soap or detergent and thoroughly rinsed to remove soap or detergent and soil. Wiping rags shall be exposed to water at a minimum temperature of 71 degrees C (160 degrees F) for at least 24 minutes during the washing process. Note: Authority cited: Sections 208 and 3901, Health and Safety Code. Reference: Section 3901, Health and Safety Code. s 30850. Single Service. "Single service" means a utensil, container, implement, wrapper, or other article designed for use only once and then discarded in the preparation, storage, display, service, consumption, or sale of food or beverage. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code. s 30851. Multiuse. "Multiuse" means a utensil, container, implement, wrapper, or other article designed for use more than once in the preparation, storage, display, service, consumption, or sale of food or beverage. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code. s 30852. Utensils and Containers, Conditions of Use and Storage. (a) Multiuse and single service drinking utensils and ice buckets shall be protected from dirt, vermin, droplet infection, overhead leakage, and other potential contamination during handling, storage, and distribution. (b) Multiuse drinking utensils or ice buckets may be used in guest rooms under the following conditions: (1) They are thoroughly washed and sanitized after each use. (2) The drinking utensils, prior to distribution, are placed in protective bags with the open end of the utensil placed in the closed end of the bag to prevent handling of the lip contact surface. (3) No utensil shall be labeled or otherwise indicate to have been cleaned and sanitized unless it has been cleaned and sanitized in accordance with Section 30853 and/or 30855. (c) Single service drinking utensils or ice buckets may be used in guest rooms under the conditions that the drinking utensils are dispensed by one of the following methods: (1) From a dispenser which keeps the lip contact surface enclosed. (2) Individually wrapped. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code. s 30853. Hand Dishwashing and Sanitizing. (a) Multiuse drinking utensils or ice buckets shall be washed and sanitized in a three-compartment metal sink equipped with hot and cold running water and integral metal drain boards. (b) The drinking utensils and ice buckets shall be processed in the following sequence: (1) Washed with hot water 40.5-49 degrees Celsius (105-120 degrees F) and detergent in the first sink compartment until thoroughly cleaned. (2) Rinsed in hot water 40.5-49 degrees Celsius (105-120 degrees F) in the second compartment. (3) Immersed in the third compartment containing a bactericidal solution in such concentration and for such time as specified in Section 30854. (c) A facility with a two-compartment metal sink with metal drainboards on the effective date of these regulations may continue to use such sink utilizing procedures listed in (1) and (3) of Subsection 30853(b) until replacement is necessary because of deterioration or modernization of premises. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code. s 30854. Sanitizing Solutions for Hand Dishwashing. (a) Multiuse utensils and ice buckets shall be sanitized by immersion in one of the following bactericidal solutions for a minimum of 30 seconds in the last sink compartment. (1) 100 parts per million (ppm) of available chlorine from either hypochlorite or organic chlorine approved by the Department. (2) 200 ppm of a quaternary ammonium compound approved by the Department. (3) 25 ppm of available iodine. (4) 25 ppm of iodophor. (5) 25 ppm of bromine-chlorine compounds. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code. s 30855. Machine Washing and Sanitizing. (a) All dishwashing machines shall be designed, installed, and operated to thoroughly clean and provide an effective bactericidal rinse. (b) Commercial type of dishwashing machines when used in food establishments regulated by the California Restaurant Act, shall meet all the requirements of that chapter (Chapter 11, Division 22, of the Health and Safety Code, commencing with Section 28520). These include, but are not limited to, the following: (1) Hot water sanitizing dishwashing machines. (2) Chemical sanitizing dishwashing machines approved by the Department. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code. s 30856. Sanitizing Requirements for Dishwashing Machines. (a) The hot water sanitizing commercial dishwashing machine shall be connected to a hot water system that is installed and maintained to continuously provide water at least 82.2 degrees Celsius (180 degrees F) at the final rinse manifold of the machine during the required bactericidal rinse cycle. (b) The domestic type hot water sanitizing dishwashing machine shall produce a minimum water temperature of 74 degrees Celsius (165 degrees F) during the wash and rinse cycles. (c) The commercial chemical sanitizing dishwashing machine shall produce a final rinse of one of the following: (1) A sanitizing solution of at least 50 ppm hypochlorite. (2) A sanitizing solution of at least 12.5 ppm iodophor. (3) Any other bactericidal solution approved by the Department. (d) Any other method approved by the Department. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code. s 30857. Maintenance and Construction Requirements. (a) All drinking utensils, ice buckets, shelves, sinks, dishwashing machines, and other related equipment shall be: (1) Constructed of non-toxic materials, (2) Constructed, installed, and maintained as to be readily cleanable, and (3) Kept clean and in good repair. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code. s 30858. Inspection Authority. (a) The Director, agents, or Registered Sanitarians appointed by the Director, and local health officers, Registered Sanitarians, and duly authorized agents thereof may at reasonable times enter and inspect any hotels, motels, or other public places governed by these regulations. Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections 3700 and 3701, Health and Safety Code. s 33001. Applicant. "Applicant" means a business entity either applying for an exemption pursuant to section 105310(d) of the Health and Safety Code and Section 33040 of this chapter, or applying for a reassessment of the fees pursuant to section 33050 of this chapter. "Applicant" includes any other business entity who was historically associated with the business entity making the application. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33002. Architectural Coating. "Architectural coating" means any product which is used as, or usable as, a coating applied to the interior or exterior surfaces of stationary structures and their appurtenances, to portable buildings, to pavements, or to curbs, such as house and trim paints, varnishes, stains, lacquers, industrial maintenance coatings, primers, undercoaters, and traffic coatings. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33003. Architectural Coating Distribution. "Architectural coating distribution" means any of the following: (a) The manufacturing, producing, blending, or compounding of architectural coating in this state, and the sale, donation, barter, or use of the architectural coating in this state. (b) The importing of architectural coating into this state with respect to which there has been no prior distribution subject to the fee, and the sale, donation, barter, or use of architectural coating in this state. (c) The receiving in this state by a distributor of architectural coating with respect to which there has been no prior distribution subject to the fee, or the receipt in this state by any business entity of architectural coating with respect to which there has not been a prior distribution on which a fee has been paid pursuant to this section, and the sale, donation, barter, or use of the architectural coating in this state. (d) The sale of architectural coatings by any business entity required to be registered pursuant to Revenue and Taxation Code Section 6001 et seq., when it is shipped into this state by the seller or delivered by the seller to a carrier, customs broker, or forwarding agent, whether hired by the order of the purchaser or not, for shipment into this state for subsequent sale, donation, barter, or use in this state. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33004. Architectural Coating Distributor. "Architectural coating distributor" means each business entity that distributes or has distributed architectural coatings, excluding each business entity that the Department has: (a) Currently granted an exemption pursuant to section 33040; (b) Determined to be insolvent; or (c) Determined did not distribute architectural coatings in or about 1978, and is not historically associated with an architectural coating distributor which distributed architectural coatings in or about 1978. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33005. Appurtenance. "Appurtenance" means accessories to an architectural structure, such as hand railings, cabinets, bathroom and kitchen fixtures, fences, decking, furniture, rain-gutters and down spouts, window screens, lamp-posts, heating and air conditioning equipment, other mechanical equipment, large fixed stationary tools and concrete forms. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33006. Business Entity. "Business entity" means any natural person, or form of business organization, including, but not limited to, a corporation, trust, firm, joint stock company, business concern, partnership, limited liability company, or association. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33007. Department. "Department" means the State Department of Health Services. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105280(c), 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105280(c), 105310 and 124165, Health and Safety Code. s 33008. Environmental Lead Contamination. "Environmental lead contamination" means the persistent presence of lead in the environment, in quantifiable amounts, that results in ongoing and chronic exposure to children. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105280(g), 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105280(g), 105310 and 124165, Health and Safety Code. s 33009. Fee. "Fee" means a fee imposed under Health and Safety Code section 105310 and implementing regulations. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33010. Historically Associated. "Historically Associated" means that the business entity has a significant relationship to another business entity, such as a business entity which: (a) Is the alter ego, successor, successor-in-interest, or predecessor, in full or part, of another business entity; (b) Purchased controlling or significant interest in another business entity; (c) Exists by way of incorporation of a privately held business entity; (d) Exists by way of a merger, consolidation, or reorganization of another business entity; (e) Acquired the products of another business entity, unless the business entity from which the products were acquired is assessed a fee for the same products; (f) Acquired the goodwill of another business entity, unless the business entity from which the goodwill was acquired is assessed a fee for the same products. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33011. Industry. "Industry" means motor vehicle fuel distributors, architectural coating distributors, or facilities releasing lead into ambient air in California. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33012. Motor Vehicle Fuel. "Motor vehicle fuel" means gasoline, natural gasoline, blends of gasoline and alcohol containing more than 15 percent gasoline, and any inflammable liquid, by whatever name the liquid may be known or sold, which is used or is usable for propelling motor vehicles operated or suitable for operation on the highway. "Motor vehicle fuel" does not include kerosene, liquefied petroleum gas, natural gas in liquid or gaseous form, ethanol, methanol, or inflammable liquids specifically manufactured for racing motor vehicles which do not contain gasoline or natural gasoline and which are distributed and used for racing motor vehicles at a racetrack. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33013. Motor Vehicle Fuel Distribution. "Motor vehicle fuel distribution" means any of the following: (a) The refining, manufacturing, producing, blending, or compounding of motor vehicle fuel in this state, and the sale, donation, barter, or use of motor vehicle fuel in this state. (b) The importing of motor vehicle fuel into this state with respect to which there has been no prior distribution subject to the fee, and the sale, donation, barter, or use of motor vehicle fuel in this state. (c) The receiving in this state by a motor vehicle fuel distributor of motor vehicle fuel with respect to which there has been no prior distribution subject to the fee, or the receipt in this state by any business entity of motor vehicle fuel with respect to which there has not been a prior distribution on which a fee has been paid pursuant to this section, and the sale, donation, barter, or use of the motor vehicle fuel in this state. (d) The sale of motor vehicle fuel by any business entity required to be registered pursuant to Revenue and Taxation Code Section 6001 et seq., when it is shipped into this state by the seller or delivered by the seller to a carrier, customs broker, or forwarding agent, whether hired by the order of the purchaser or not, for shipment into this state for subsequent sale, donation, barter, or use in this state. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33014. Motor Vehicle Fuel Distributor. "Motor vehicle fuel distributor" means each business entity that distributes or has distributed motor vehicle fuel excluding each business entity that the Department has: (a) Currently granted an exemption pursuant to section 33040; (b) Determined to be insolvent; or (c) Determined did not distribute motor vehicle fuel in or about 1991, and is not historically associated with a motor vehicle fuel distributor which distributed motor vehicle fuel in or about 1991. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33015. Ongoing and Chronic Exposure. "Ongoing and chronic exposure" means exposure to lead that has been dispersed into the environment by industry which has not been abated in accordance with Title 17, California Code of Regulations, Division 1, Chapter 8, section 35001 et seq. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105250, 105310, 124160(b) and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105250, 105310, 124160(b) and 124165, Health and Safety Code. s 33020. Fees Attributable to Leaded Architectural Coatings. (a) Each architectural coating distributor shall pay a fee assessed and collected by the Board of Equalization pursuant to Health and Safety Code section 105310 and calculated as follows: A ____ x D B WHERE: A = Total gallons of architectural coatings distributed in or about 1978 by each architectural coatings distributor, as estimated by the Department based upon the best available data compiled and held by the Department. B = Total gallons of architectural coating distributed in or about 1978 by all architectural coating distributors, as estimated by the Department based upon the best available data compiled and held by the Department. D = $2,260,000.00 + the annual adjustment pursuant to Health and Safety Code section 105310(c). (b) The fee is due on or before April 1 of each year. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33025. Fees Attributable to Leaded Gasoline. (a) Each motor vehicle fuel distributor shall pay a fee, assessed and collected annually by the Board of Equalization pursuant to Health and Safety Code section 105310 and calculated as follows: A ____ x D B WHERE: A = Total gallons of motor vehicle fuel distributed in or about 1991 by each motor vehicle fuel distributor, as estimated by the Department based upon the best available data compiled and held by the Department. B = Total gallons of motor vehicle fuel distributed in or about 1991 by all motor vehicle fuel distributors, as estimated by the Department based upon the best available data compiled and held by the Department. D = $13,640,000.00 + the annual adjustment pursuant to Health and Safety Code section 105310(c). (b) The fee is due on or before April 1 of each year. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33030. Fees Attributable to Facilities Releasing Lead into Ambient Air in California. (a) Facilities currently reporting releases of lead into ambient air in California pursuant to the Superfund Amendments and Reauthorization Act, Title III, Section 313, shall pay a fee, assessed by the Board of Equalization pursuant to Health and Safety Code section 105310 and calculated as follows: A ____ x C B WHERE: A = The total pounds of lead reported to be released by each facility into the California ambient air in the most recent calendar year for which data are available, as reported pursuant to the Superfund Amendments and Reauthorization Act, Title III, Section 313. B = The total pounds of lead reported to be released by all facilities into California ambient air in the most recent calendar year for which data are available, as reported pursuant to the Superfunds Amendments and Reauthorization Act, Title III, Section 313. C = $100,000 + the annual adjustment pursuant to Health and Safety Code section 105310(c). (b) The fee is due on or before April 1 of each year. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105310 and 124165, Health and Safety Code. s 33040. Exemption From Fees. (a) An exemption from the fee imposed under Health and Safety Code section 105310 shall be granted to an applicant who can demonstrate, as determined by the Department, that all of the following are true: (1) The industry with which the applicant is associated is not currently engaged in the stream of commerce of lead or products containing lead; (2) The industry with which the applicant is associated was not historically engaged in the stream of commerce of lead or products containing lead; (3) The industry with which the applicant is associated is not otherwise responsible for identifiable sources of lead which currently contribute to environmental lead contamination; (4) The industry with which the applicant is associated is not otherwise responsible for identifiable sources of lead which have historically contributed to environmental lead contamination. (b) An applicant who does not seek or who fails to demonstrate entitlement to an exemption under subsection (a) shall qualify for an exemption if the applicant can demonstrate, as determined by the Department, that either: (1) The applicant's industry did not contribute in any manner to environmental lead contamination, or (2) the applicant's lead, or products containing lead, with which the applicant is currently, or was historically, associated does not currently, or did not historically, result in environmental lead contamination. (c) It shall be presumed that the applicant is subject to the fee until the applicant establishes the contrary to the satisfaction of the Department. The presumption may be rebutted by providing a complete application and any other documentation that the Department requires to establish the applicant's entitlement to the exemption. Contents of an application shall include, but are not limited to: (1) A thorough statement, made under penalty of perjury, which demonstrates the applicant's entitlement to the exemption. The sworn statement shall also contain the declarant's basis of knowledge for making the statements contained therein. If the person making the statement is not reasonably available to the applicant, a certified copy of a transcript of sworn testimony may be submitted. If such prior sworn testimony is used, the applicant must also provide a declaration as to why the declarant is not available. More than one statement may be submitted when necessary to prove the elements of the exemption. (2) Records providing the information specified below shall be submitted in duplicate with a sworn statement under penalty of perjury establishing the reliability and completeness of the records, including a description of their mode of preparation and maintenance: (A) The formulation for all products manufactured and all products sold by the applicant, including the International Union of Pure and Applied Chemical (IUPAC) name and Chemical Abstract Service (CAS) number for all ingredients used; (B) The total amount of lead manufactured, distributed, and sold each year in the applicant's products; (C) Any actions taken by the applicant to abate the lead dispersed into the environment by the applicant's products in accordance with Title 17, California Code of Regulations, Division 1, Chapter 8, section 35001 et seq; (D) Each business entity from whom the applicant purchased lead pigments, lead dryers, and any other lead-containing ingredients used to manufacture the applicant's products, including name, address, contact name, phone number, type of lead-containing ingredient, total amount of lead-containing ingredients purchased, and year purchased; (E) Any records, or portion thereof, which the applicant wants to protect as a trade secret shall be submitted in a separate sealed envelope clearly marked on the outside as "Trade Secret Material." For purposes of this section, "trade secret" shall have the same meaning as in the Uniform Trade Secrets Act, Civil Code section 3426 et seq. The application shall contain a declaration under penalty of perjury describing why the applicant believes the material is a trade secret. After review, the Department will either grant the trade secret request and keep the material confidential, or deny the request, return all copies of the trade secret material to the applicant, and not consider the trade secret material in its determination. The Department's refusal to grant a requested claim of trade secret does not excuse the applicant from establishing all elements of the claim for exemption. Any material which the Department agrees to consider as a trade secret shall be exempt from disclosure under the Public Records Act, Government Code section 6250 et seq. Records for which the Department has denied protection as a trade secret shall also be exempt from disclosure under the Public Records Act during the time the records are in the possession of the Department. (3) A cover letter containing the name and address of the applicant, the applicant's Board of Equalization account number, the name, address and telephone number of the person to contact about the application, a summary of the basis for the exemption, and a listing of all items included with the application. (d) The application shall be delivered to the Department at the following address: Fee Exemption Request Childhood Lead Poisoning Prevention Branch Department of Health Services 1515 Clay Street #1801 Oakland, CA 94612 (e) An exemption granted under this section is valid for a period specified by the Department of at least one calendar year. (f) A business entity seeking to continue an exemption under this section shall re-apply to the Department at least 30 days prior to the end of the period specified by the Department pursuant to section 33040(e). (1) If the facts underlying the business entity's previous application for exemption have not changed, then an application for continued exemption shall consist of a sworn declaration stating there has been no change and the declarant's basis of knowledge for making such statement. (2) If there has been a change in the facts underlying the business entity's previous application for exemption, then a sworn declaration shall address in detail the nature of the changes. In addition, the application for continued exemption shall include records proving the applicant's entitlement for the exemption, as specified in section 33040(c)(2). (g) The Department may, in its sole discretion, decide the application for exemption or continued exemption based upon the information submitted, or may request the submission of additional information prior to making a written decision. If the applicant does not provide the additional material requested by the Department, then the Department may decide the matter based upon the material already presented. (h) The Department shall either grant or deny the exemption or continued exemption. (1) If the application for exemption or continued exemption is denied, the applicant may, within 30 days after receipt of the Department's written decision, request reconsideration of the decision from the Department. The request for reconsideration shall be in writing, and shall detail the reasons why the applicant believes the original decision was in error. (2) The Department may decide the matter based upon the record submitted in the application, or may request the submission of additional information. The Department's decision on the reconsideration shall be in writing, and shall either grant the exemption or continued exemption, or specify the reasons for its denial. (i) An applicant who has paid the fee, and thereafter been granted an exemption by the Department, may apply for a refund to the Board of Equalization. The request for a refund must be in writing and mailed to: State board of equalization Fuel Taxes Division, MIC:30 p.o. box 942879 Sacramento, ca 94279-0001 Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105250, 105310, 124160(b) and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105250, 105310, 124160(b) and 124165, Health and Safety Code. s 33050. Application to Reassess Fee. (a) An applicant requesting a reassessment of the fee imposed under Health and Safety Code section 105310 shall submit an application to the Department which contains: (1) A statement or statements, made under penalty of perjury, which demonstrates the applicant's entitlement to a reassessed fee, and which includes a statement that the applicant has paid in full any and all fees assessed by the Board of Equalization pursuant to this Chapter. The sworn statement(s) shall also contain the basis of knowledge for making the statements contained therein. (2) Records identifying the total gallons of motor vehicle fuel distributed by the applicant in or about 1991 or the total gallons of architectural coatings distributed by the applicant in or about 1978. Records, such as sales data, annual reports, or other information, shall be submitted in duplicate with a sworn statement under penalty of perjury establishing the reliability and completeness of the records, including a description of their mode of preparation and maintenance. Any records, or portion thereof, which the applicant wants to protect as a trade secret shall be submitted in a separate sealed envelope clearly marked on the outside as "Trade Secret Material." For purposes of this section, "trade secret" shall have the same meaning as in the Uniform Trade Secrets Act, Civil Code section 3426 et seq. The application shall contain a declaration under penalty of perjury describing why the applicant believes the material is a trade secret. (3) A cover letter containing the name and address of the applicant, the applicant's Board of Equalization account number, the name, address and telephone number of the person to contact about the application, a summary of the basis for the exemption, and a listing of all items included with the application. (b) If the application is denied, the applicant may, within 30 days after receipt of the Department's written decision, request reconsideration of the decision from the Department. The request for reconsideration shall be in writing, and shall detail the reasons why the applicant believes the original decision was in error. (c) Any claim for refund shall be submitted to the Board of Equalization by the applicant within the statutory time frames established by Revenue and Taxation Code Section 43451 et seq. Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105250, 105310, 124160(b) and 124165, Health and Safety Code.Authority cited: Section 105310, Health and Safety Code. Reference: Sections 105250, 105310, 124160(b) and 124165, Health and Safety Code. Note: Authority cited: Sections 208 and 13111.3, Health and Safety Code. s 35001. Abatement. "Abatement" means any set of measures designed to reduce or eliminate lead hazards or lead-based paint for public and residential buildings, but does not include containment or cleaning. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35002. Accreditation. "Accreditation" means the Department has reviewed and finds acceptable a training provider's written application for accreditation, and has conducted and finds acceptable, an on-site audit as specified in subsection 35078(e). Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35003. Accredited Training Provider. "Accredited training provider" means any individual, corporation, partnership or other unincorporated association or public entity to which the Department has granted accreditation or provisional accreditation to offer lead-related construction courses and continuing education instruction. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35004. Certified Industrial Hygienist. Note: Authority cited: Sections 208, 309.76 and 429.16, Health and Safety Code. Reference: Sections 208, 309.76 and 429.16, Health and Safety Code. s 35005. Certified Lead Inspector/Assessor. "Certified lead inspector/assessor" means an individual who has received a certificate or an interim certificate from the Department as a "certified lead inspector/assessor". Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35006. Certified Lead Project Designer. "Certified lead project designer" means an individual who has received a certificate or an interim certificate from the Department as a "certified lead project designer". Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35007. Certified Lead Project Monitor. "Certified lead project monitor" means an individual who has received a certificate or an interim certificate from the Department as a "certified lead project monitor". Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35008. Certified Lead Supervisor. "Certified lead supervisor" means an individual who has received a certificate or an interim certificate from the Department as a "certified lead supervisor". Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35009. Certified Lead Worker. "Certified lead worker" means an individual who has received a certificate from the Department as a "certified lead worker". Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35010. Certificate. "Certificate" means the document issued by the Department to an individual who meets the requirements for certification as described in sections 35083, 35085, 35087, 35089, or 35091. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35011. Guest Instructor. Note: Authority cited: Sections 208, 309.76 and 429.16, Health and Safety Code. Reference: Sections 208, 309.76 and 429.16, Health and Safety Code. s 35012. Certified Industrial Hygienist. "Certified industrial hygienist" (CIH) means a person who has met the education, experience, and examination requirements of an industrial hygiene certification organization governed by the American Board of Industrial Hygiene. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35013. Clearance Inspection. "Clearance inspection" means an on-site limited investigation, as described in Chapter 15: Clearance, sections II-VI, "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, June 1995. Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. s 35014. Component. "Component" means a structural element or fixture, such as a wall, floor, ceiling, door, window, molding, trim, trestle, tank, stair, railing, cabinet, gutter, or downspout. Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. s 35015. Contact Hour. "Contact hour" means 60 minutes of lead-related construction training which may include a break of not more than ten minutes. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35016. Containment. "Containment" means a system, process, or barrier used to contain lead hazards inside a work area such as described in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, June 1995, Chapter 8, "Containment and Barrier Systems," Table 8.1, Table 8.2, and Table 8.3, or "Guide for Containing Debris Generated During Paint Removal Operations," Steel Structures Painting Council, SSPC Publication No. 96-12, 1996. Note: Authority cited: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. Reference: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. s 35017. Job Tasks. Note: Authority cited: Sections 208, 309.76 and 429.16, Health and Safety Code. Reference: Sections 208, 309.76 and 429.16, Health and Safety Code. s 35018. Continuing Education. "Continuing education" means lead-related construction instruction, other than a course as described in section 35023, that satisfies the requirements specified in section 35070 or 35072. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35019. Course Completion Form. "Course Completion Form" means documentation, on DHS Form 8493 (12/97), issued by an accredited training provider to an individual and the Department as proof of successful completion of a DHS-approved lead-related construction course or continuing education instruction. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35020. Demonstration Testing. "Demonstration testing" means the observation and scoring by an instructor or a guest instructor of an individual student's job task and equipment use skills taught during a course or continuing education instruction. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35021. Department. "Department" means the California Department of Health Services (DHS). Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35022. Deteriorated Lead-Based Paint. "Deteriorated lead-based paint" means lead-based paint or surface coating that is cracking, chalking, flaking, chipping, peeling, non-intact, failed, or otherwise separating from a component. Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. s 35023. DHS-Approved Course. "DHS-approved course" means any lead-related construction course that satisfies the requirements specified in sections 35056, 35057, 35061, 35065, 35066, or 35067 as determined by DHS pursuant to sections 35076 and 35078. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35024. Photo Identification Number. Note: Authority cited: Sections 208, 309.76 and 429.16, Health and Safety Code. Reference: Sections 208, 309.76 and 429.16, Health and Safety Code. s 35025. Guest Instructor. "Guest instructor" means an individual who is responsible for providing less than 30% of training in any course. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35026. Hands-on Training. "Hands-on training" means training during which students practice skills that they will be expected to perform at the worksite. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35027. Industrial Building. "Industrial building" means a structure that is used primarily for industrial activity, which is generally not open to the public, including but not limited to, warehouses, factories, and storage facilities. "Industrial building" does not include any structure which fits the definition of a public building or a residential building. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35028. Instructor. "Instructor" means an individual who is responsible for providing 30% or more of training in any course or continuing education instruction. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35029. Interactive/Participatory Teaching Methods. "Interactive/participatory teaching methods" mean instruction which consists of active participation of the students, such as brainstorming, hands-on training, demonstration and practice, small group problem-solving, learning games, discussions, risk mapping, field visits, walk-throughs, problem-posing, group work assignments, homework review sessions, question-and-answer periods, skits, or role-playing sessions. Lecture is not considered an interactive/participatory teaching method. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35030. Interim Certificate. "Interim certificate" means the document issued by the Department to an individual who meets the requirements for interim certification as described in section 35093. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35031. Update Course. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35032. Job Tasks. "Job tasks" means the specific activities performed in the context of work. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35033. Lead-Based Paint. "Lead-based paint" means paint or other surface coatings that contain an amount of lead equal to, or in excess of one milligram per square centimeter (1.0 mg/cm <>2) or more than half of one percent (0.5%) by weight. Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. s 35034. Lead Certification Examination. "Lead certification examination" means the statewide examination offered by the Department to applicants for certification. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35035. Lead-Contaminated Dust. "Lead-contaminated dust" means dust that contains an amount of lead equal to, or in excess of, fifty micrograms per square foot (50 m g/ft <>2) for interior floor surfaces, two hundred and fifty micrograms per square foot (250 m g/ft <>2) for interior horizontal window surfaces, and eight hundred micrograms per square foot (800 m g/ft <>2) for exterior floor and exterior horizontal window surfaces. Note: Authority cited: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. Reference: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. s 35036. Lead-Contaminated Soil. "Lead-contaminated soil" means bare soil that contains an amount of lead equal to, or in excess of, four hundred parts per million (400 ppm) in children's play areas and one thousand parts per million (1000 ppm) in all other areas. Note: Authority cited: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. Reference: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. s 35037. Lead Hazard. "Lead hazard" means deteriorated lead-based paint, lead contaminated dust, lead contaminated soil, disturbing lead-based paint or presumed lead-based paint without containment, or any other nuisance which may result in persistent and quantifiable lead exposure. Note: Authority cited: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. Reference: Sections 17920( l), 17920.3(c) and (k), 105250(a) and (b), 105280(g), 124160(b) and 124165, Health and Safety Code; Sections 1941, 3479, 3480 and 3481, Civil Code; Section 17274(b), Revenue and Taxation Code; and Section 11349(c) and (e), Government Code. s 35038. Lead Hazard Evaluation. "Lead hazard evaluation" means the on-site investigation, for compensation, of lead-based paint or lead hazards, such as a lead inspection, risk assessment, and clearance inspection, for public and residential buildings, but does not include activities intended to determine adequacy of containment or compliance with the regulatory requirements specified in Title 8, California Code of Regulations, section 1532.1, Title 17, California Code of Regulations, sections 70100 and 70200, Title 22, California Code of Regulations, Division 4.5, Chapters 10, 11, 12, 13, and 18, and California Health and Safety Code, section 25163, subdivision (C). Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. s 35039. Lead Inspection. "Lead inspection" means a surface by surface investigation to determine the presence of lead-based paint as described in Chapter 7: Lead-Based Paint Inspection, "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, 1997 Revision. Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. s 35040. Lead-Related Construction Work. "Lead-related construction work" means any construction, alteration, painting, demolition, salvage, renovation, repair, or maintenance of any residential or public building, including preparation and cleanup, that, by using or disturbing lead-containing material or soil, may result in significant exposure of adults or children to lead. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35041. Photo Identification Number. "Photo identification number" means the number listed on a form of photo identification, such as a passport or California Department of Motor Vehicles driver's license or identification card, which matches a trained individual with a Course Completion Form. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35042. Postsecondary Education. "Postsecondary education" means education completed at a junior college, college, or university accredited by a national or regional accrediting agency which is recognized by the U.S. Department of Education or a state agency authorized to approve such institutions. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35043. Presumed Lead-Based Paint. "Presumed lead-based paint" means paint or surface coating affixed to a component in or on a structure, excluding paint or surface coating affixed to a component in or on a residential dwelling constructed on or after January 1, 1979, or a school constructed on or after January 1, 1993. Note: Authority cited: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. Reference: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. s 35044. Provisional Accreditation. "Provisional accreditation" means the Department has reviewed and finds acceptable a training provider's written application for accreditation, but has not conducted an on-site audit as specified in subsection 35078(e). Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35045. Public Building. "Public building" means a structure which is generally accessible to the public, including but not limited to, schools, daycare centers, museums, airports, hospitals, stores, convention centers, government facilities, office buildings and any other building which is not an industrial building or a residential building. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35046. Residential Building. "Residential Building" means a structure which is used or occupied, or intended to be used or occupied, in whole or in part, as the home or residence of one or more persons. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35047. Risk Assessment. "Risk Assessment" means an on-site investigation to determine the existence, nature, severity, and location of lead hazards, as described in Chapter 5: Risk Assessment, section II(A), (B), (C) and (D), "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, June 1995. Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. s 35048. Train-the-Trainer Course. "Train-the-trainer course" means a course that includes, but is not limited to, instruction in the planning and teaching of adult education, adult learning principles, designing training objectives, selecting and designing training activities, creating an effective learning environment, facilitating group involvement and discussions, and strategies for dealing with difficult training situations and difficult learners. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35049. Training Director. "Training Director" means the individual, designated by an accredited training provider, who monitors the performance and qualifications of instructors and guest instructors, the quantity and quality of training provided, and who is responsible for ensuring that an accredited training provider complies with the requirements for accreditation. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35050. Work Area. "Work area" means an area where lead-based paint or presumed lead-based paint is disturbed, or abatement is conducted. Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. s 35051. Representation of Accreditation Status. Unless accredited pursuant to the requirements of this chapter, no person shall represent himself or herself as, or do business as, an accredited training provider. Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 16240 and 17200, Business and Professions Code. s 35052. Eligibility Requirements. To qualify for and maintain accreditation, a training provider shall conduct at least one DHS-approved course in California at least once during each calendar year, satisfy the applicable requirements specified in sections 35053 and 35054 and comply with all applicable requirements specified in sections 35076 and 35078. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35053. Personnel Requirements. (a) Each course shall be administered by a Training Director with the following minimum qualifications: (1) Two years of experience administering training programs or two years of experience teaching or training adults; (2) Successful completion of a 40 hour train-the-trainer course, or two years experience teaching or training adults, or an associate degree or higher in education from a postsecondary educational institution; (3) A bachelor or graduate-level degree in building construction technology, engineering, industrial hygiene, safety, or health, or two years of experience managing an environmental or occupational health and safety program; and (4) Successful completion of 24 contact hours of lead-related construction training from any of the required topics listed in sections 35056, 35057, 35061, or 35065. (b) Each course shall be taught by an instructor with the following minimum qualifications: (1) Successful completion of a 40 hour train-the trainer course, or one year of experience teaching or training adults, or an associate degree or higher in education from a postsecondary educational institution; (2) Successful completion of 24 contact hours of lead-related construction training from any of the required topics listed in sections 35056, 35057, 35061, or 35065; (3) One year of experience related to health, safety, or regulatory aspects of lead-related construction in the topic area of the lead-related construction course they will be teaching or one year of lead-related construction experience in the topic area of the lead-related construction course they will be teaching, or DHS certification in the discipline of the course in which they will be teaching. Except that, instructors of hands-on training must have two years of lead-related construction or related experience in the topic area of the lead-related construction course they will be teaching; and (4) Successful completion of seven contact hours of continuing education instruction annually. (c) Only an instructor receiving a satisfactory annual performance review by the Training Director shall provide course or continuing education instruction, unless the instructor is also the Training Director. (d) Each qualified guest instructor shall have a minimum of one year of experience related to the subject matter that they teach. Except that, guest instructors of hands-on training shall have a minimum of two years of lead-related construction or related experience. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35054. Operational Requirements. (a) An accredited training provider shall provide facilities for classroom instruction, hands-on training, and simulated field visits. The training provider shall also provide equipment, instructional material, and instructor personnel to provide training needed to achieve the objectives for which the course or continuing education instruction is offered. Equipment shall be maintained in proper working condition and licensed and stored in compliance with applicable requirements and regulations. (b) A student-to-instructor ratio of not greater than ten to one shall be maintained during hands-on training and instructors shall provide attention to and observation of each student's activities. (c) Only an accredited training provider shall be approved to offer continuing education instruction. (d) An accredited training provider shall administer a final examination to eligible students seeking a Course Completion Form in each course or continuing education instruction. (e) A minimum score of 70% shall be considered a passing score on a final examination. (f) An accredited training provider shall allow a student who fails to attain a passing score on a final examination to retake the examination up to two more times within 30 calendar days from the date the original examination was given. These examinations shall be different from, but equivalent to, the original final examination. (g) Within 30 calendar days of a student passing a final examination, an accredited training provider shall issue a completed Course Completion Form to the student and the Department. (h) A final examination shall be designed to test a student's knowledge of information and ability to perform job tasks taught in a course or continuing education instruction. This examination may be administered verbally or in written form, shall be given to student's individually, shall include demonstration testing if hands-on training is done, and shall consist of the following: (1) Demonstration testing shall comprise a minimum of 15% and shall not exceed 35% of the final examination, except for the lead-related construction work course which shall not exceed 50%; (2) A minimum of 100 questions for the lead-related construction inspection and assessment course and the lead-related construction supervision and project monitoring course; (3) A minimum of 75 questions for the lead-related construction Certified Industrial Hygienist course; (4) A minimum of 50 questions for the lead-related construction work course, the lead-related construction project design course, and the lead-related construction supplemental supervision and project monitoring course; or (5) A minimum of five questions for each contact hour of continuing education instruction. (i) DHS Form 8493 (12/97), Course Completion Form, shall contain the following information: (1) Student's name, residence address (and mailing address, if different), telephone number, and date of birth; (2) Student's photo identification number and description of type of identification document; (3) Student's authorization to release, to the Department, information contained on DHS Form 8493 (12/97), Course Completion Form; (4) Student's verification of understanding that possession of the Course Completion Form does not constitute certification by DHS; (5) Student's verification of understanding that, to be eligible for interim certification or certification renewal, an application for interim certification or certification shall be made to DHS within one year of successful completion of the final examination; (6) Student's signature and date; (7) Accredited training provider's name; (8) Title and number of the course or continuing education instruction; (9) Number of contact hours completed; (10) Dates and location(s) of the course or continuing education instruction and DHS Form 8493 (12/97) Course Completion Form Number and date of student's completion of core instruction if different; (11) Date the student passed the course or continuing education final examination; and (12) Training Director's name, printed or typed, signature, and date verifying, under penalty of perjury, that all information contained on DHS Form 8493 (12/97), Course Completion Form, is true and correct. (j) An accredited training provider shall maintain, at its principal place of business in California, for at least five years, accurate records of the following: (1) Daily student attendance; (2) Examination results for each student, including results of demonstration testing; (3) Completed Course Completion Forms; (4) Training Director and instructor qualifications; (5) Documentation of approval or authority to operate granted by the Bureau for Private Postsecondary and Vocational Education; (6) Current course curriculum materials and documents reflecting any changes made to these materials; (7) Examinations for each course, including demonstration testing protocol; and (8) Completed student evaluation forms for each course. (k) An accredited training provider shall notify DHS at least 48 hours prior to offering or canceling a course or continuing education training. The notification shall include type of course or training, instructor(s), date(s), time(s), and location(s), including street address. (l) An accredited training provider shall submit documentation of instructor qualifications as specified in s35053(b) to DHS at least 48 hours prior to an instructor teaching a course or continuing education. (m) An accredited training provider shall maintain approval or authority to operate granted by the Bureau for Private Postsecondary and Vocational Education. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35055. Core Instructional Requirements. (a) Each course, except the lead-related construction work course, shall include a minimum of five contact hours of the following core instructional requirements: (1) At least one contact hour of background information on lead and health effects related to lead exposure, including: (A) Identification of sources of environmental lead such as surface dust, soil, water, air, and food; (B) History of uses and locations of lead and leaded paint in buildings; (C) Lead contaminated dust and lead-based paint properties; (D) Summary of lead abatement control options, including interim controls; (E) The nature of lead-related diseases; (F) Pathways of exposure in children and adults; (G) Dose-response relationships, and blood lead levels in children and adults; (H) Effects on the nervous, reproductive (male and female), musculo-skeletal, cardiovascular, and blood-forming systems and kidneys; (I) Different effects on children and adults, including women during pregnancy; (J) Symptoms and diagnosis of poisoning in children and adults and DHS-reportable blood lead levels; (K) Medical treatment for lead poisoning, including, chelation therapy; and (L) How lead in the body is absorbed, distributed, and eliminated. (2) At least one contact hour on relevant federal, state and local regulatory requirements including: (A) Requirements for the identification, management, transport, record keeping, and disposal of hazardous waste set forth in Title 22, California Code of Regulations, Division 4.5, Chapters 10, 11, 12, 13, and 18, Health and Safety Code section 25163, subdivision (c), and Chapter 6.5, Article 10.8, of the Health and Safety Code; (B) Ambient Air Quality Standards for lead set forth in Title 17, California Code of Regulations, sections 70100 and 70200; (C) Injury and Illness Prevention Program requirements set forth in Title 8, California Code of Regulations, sections 1509 and 3203; (D) California's Construction Safety Orders set forth in Title 8, California Code of Regulations, section 1532.1; and (E) Standards for hazard communication in the work place set forth in the "Clear and Reasonable Warnings," Title 22, California Code of Regulations, subsections 12601(c) & (d) and in "Hazard Communication," Title 8, California Code of Regulations, section 5194. (3) At least one contact hour on respiratory protection and personal protective equipment including: (A) Standards and criteria for establishing a respiratory protection program set forth in Title 8, California Code of Regulations, sections 5141 and 5144 and Occupational Safety and Health Administration (OSHA) respirator requirements set forth in 29 Code of Federal Regulations, section 1910.134 (1998); (B) Classes and characteristics of respirators; (C) Limitations of respirators; (D) Proper selection, inspection, donning, doffing, use, maintenance, and storage procedures for respirators; (E) Methods for field testing the face piece seal (user seal check procedures); (F) Qualitative and quantitative fit testing procedures; (G) Factors that alter respirator fit, e.g. facial hair; (H) Selection and use of personal protective clothing; (I) Storage and handling of non-disposable clothing; and (J) Proper use of protective clothing and equipment set forth in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1. (4) Discussion of the roles and responsibilities of the interim certified individual, the need for further on-the-job training and the need to work with other personnel during lead-related construction activities, including public health and housing agency officials. (b) Individuals in possession of a DHS Form 8493 (12/97), Course Completion Form in any course, except a lead-related construction Work course, shall not be required to retake the core instructional requirements when seeking a Course Completion Form in another course, provided the course begins no more than three years after the date of the final examination on the initial Course Completion Form. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35056. Course Requirements. (a) A lead-related construction Inspection and Assessment course shall consist of a minimum of 40 contact hours which includes core instructional requirements specified in section 35055, methodology requirements specified in subsection 35056(b), hands-on training, as specified in subsection 35056(c), and classroom instruction, as specified in subsection 35056(d). (b) At least 16 of the 40 required contact hours shall be taught using interactive/participatory teaching methods, which includes at least ten contact hours of hands-on training. (c) Hands-on training shall include performance of tasks associated with: (1) Inspection and hazard assessment techniques as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; (2) Participation in a simulated field visit which includes: (A) Walk-through building inspection; (B) Discussion of data collection, including sample location determination; and (C) Practice with an X-ray Fluorescence (XRF) analyzer. (d) Classroom instruction shall include: (1) Federal guidelines as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision. (2) State regulations specified in Title 17, California Code of Regulations, Division 1, Chapter 8, Sections 36000 and 36100. (3) Roles and responsibilities of local health officials versus private sector Inspector/Assessors when conducting lead hazard assessments. (4) Potential hazard exposure circumstances, including, but not limited to, electrical, heat stress, fire, explosion, and chemical air contaminants, slips, trips, falls and disturbances of friable asbestos. (5) At least one contact hour on radiation information and safety training requirements as follows: (A) DHS radiation safety training requirements as specified in Title 17, California Code of Regulations, sections 30100-30355; (B) Ionizing radiation including atomic structure, units of radiation, radioactivity, radioactive decay, ionization, radiation absorption in matter, and radiation detection; and (C) Safe use of X-ray florescent (XRF) analyzers, including direct and indirect analyzers and limitations (substrate interference), transportation, storage, record keeping and license requirements. (6) At least five contact hours on job tasks associated with lead hazard inspection procedures as follows: (A) Review and interpretation of previous inspection records, including sample collection and analysis, abatement activities, and source information; (B) Inspection plan development, including notification of property owners and occupants, building access, use of warning signs, and disruption minimization. (C) Hazard communication with property owners, occupants, and neighbors relative to the reduction or elimination of sources of lead at the job site such as paint, dust, soil, water, imported ceramic pottery, home remedies, or occupational take-home sources; (D) Visual inspections and clearance inspections; (E) Sample collection including equipment, procedures, quality assurance and contamination factors before, during and after abatement, as described in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; (F) Sample analysis, including selection of an EPA recognized laboratory under the National Lead Laboratory Accreditation Program to test paint, dust, soil samples and other media and quality assurance procedures; and (G) Post-inspection procedures and written reports. (7) At least five contact hours on job tasks associated with lead hazard risk assessment as follows: (A) HUD protocol for risk assessment and interim controls as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; (B) Assessment of leaded paint surface damage, including disturbance potential of lead-related construction work; (C) Child accessibility to leaded paint surfaces; and (D) Public and lead-related construction work personnel health considerations, including medical confidentiality. (8) Record keeping as specified in DHS radiation materials control regulations in the California Code of Regulations, title 17, sections 30100-30355; and "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision. (9) Lead-related construction techniques in residential and public buildings as follows: (A) Abatement options, including interim controls; (B) Clean-up and disposal procedures, contamination prevention and dust minimization, including high efficiency particulate air (HEPA) vacuums as described in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; and (C) Evaluation of abatement and interim controls costs. (10) Inspector/Assessor qualifications, responsibilities, legal obligations and conflicts of interest. (11) Insurance issues relating to lead-related construction, work and abatement including liability insurance, claims-made and occurrence policies, and environmental and pollution liability policy clauses, and bonding. (12) Classroom discussion of a simulated field visit. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35057. Course Requirements. (a) A lead-related construction supervision and project monitoring course shall consist of a minimum of 40 contact hours which includes core instructional requirements specified in section 35055, methodology requirements specified in subsection 35057(b), hands-on training, as specified in subsection 35057(c), classroom instruction, as specified in subsection 35057(d), and a demonstration of respirator fit testing as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1. (b) At least 16 of the 40 required contact hours shall be taught using interactive/participatory teaching methods, which includes at least eight contact hours of hands-on training. (c) Hands-on training shall include performance of tasks associated with: (1) Exposure assessment including paint chip collection and air monitoring and worker protection practices including personal protective equipment as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1; (2) Clearance inspections such as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; and (3) Lead-related construction supervision and project monitoring, including, use of engineering controls, construction and use of containment and barrier systems for at least two worksite preparation levels, removal methods, interim control methods, clean-up including high efficiency particulate air (HEPA) vacuums, use of negative air machines, and waste disposal as specified in, "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision. (d) Classroom instruction shall include: (1) Regulatory requirements as specified in: (A) National Emission Standards for Hazardous Air Pollutants set forth in Title 40, Code of Federal Regulations, section 50.12 (1992); (B) Relevant State Contractor Licensing Board requirements for conducting work as a contractor set forth in section 7026 and following of the Business and Professions Code; (C) Permitting requirements for lower risk treatment activities set forth in Health and Safety Code, Chapter 6.5, Article 9, sections 25200.3, 25201.5, and Title 22, California Code of Regulations, Division 4.5, Chapter 45; and (D) Work practice requirements set forth in Title 17, California Code of Regulations, sections 36000 and 36100. (2) Identification and prevention of hazards encountered during lead-related construction as follows: (A) Emergency procedures for sudden releases; and (B) Electrical, heat stress, fire, explosion and other hazards, chemical air contaminants, slips, trips, falls and disturbances of friable asbestos. (3) Job tasks associated with sample collection and analysis procedures as follows: (A) Sample collection equipment, and procedures, quality assurance methods and contamination factors before, during and after abatement, as described in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; (B) Sample analysis, including interpretation and quality assurance procedures; and (C) Visual inspections and clearance inspections. (4) At least five contact hours on job tasks associated with lead-related construction including the following: (A) Interior and exterior leaded paint, soil and dust abatement methods (including chemical, enclosure, hand, mechanical, blasting, encapsulation), interim control methods, use of engineering controls, clean-up techniques (including high efficiency particulate air (HEPA) vacuums), and worksite preparation (including use of negative air machines), as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; (B) Lead-related construction work and abatement as a portion of a renovation project; (C) Notification of other contractors working at the lead-related construction site; (D) Work practices as follows: 1. Construction, use, and maintenance of containment and barrier systems; 2. Warning signs and their placement; and 3. Electrical and ventilation systems lockout. (E) Meeting housing codes and standards; (F) Special lead-related construction procedures for occupied buildings, including strategies for occupant education, occupant and furniture relocation, and lead exposure minimization; (G) Development of detailed schedules to comply with project design requirements and execution of tasks, including but not limited to, resident notification, building access, warning signs, and occupant disruption minimization; (H) Identification and implementation of personal hygiene practices including, but not limited to, entry and exit procedures for the work area, provision and use of showers; and avoidance of eating, drinking, smoking, chewing, and applying cosmetics in the work or changing area; (I) Hazard communication with property owners, occupants and neighbors relative to the reduction or elimination of sources of lead at the job site such as paint, lead dust, soil, water, imported ceramic pottery, home remedies, and occupational take-home exposures; and (J) Administrative tasks associated with supervision and project monitoring: 1. Contract specifications, preparation and administration; 2. Cost estimation, including strategies for cost reduction; 3. Development and administration of an illness and injury prevention program; and 4. Record keeping as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1. (5) Supervision and project monitoring job tasks associated with lead-related construction project design as follows: (A) Review of inspection reports; (B) Performance of clearance testing methods as described in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; and (C) Performance of hazardous waste segregation, testing, and disposal. (6) Conflicts of interest related to the performance of supervision, inspection, and project monitoring tasks. (7) Medical surveillance and removal protection as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1, including but not limited to, issues involved in selecting and using medical services; (8) Insurance issues relating to lead-related construction including: (A) Workers' compensation coverage and exclusions; and (B) Liability insurance, claims-made and occurrence policies, environmental and pollution liability policy clauses, and bonding. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35061. Course Requirements. (a) A lead-related construction project design course shall consist of a minimum of 16 contact hours which includes methodology requirements specified in subsection 35061(b), classroom instruction as specified in subsection 35061(c) and a simulated field site visit as specified in subsection 35061(d). (b) At least 6 of the 16 required contact hours shall be taught using interactive/participatory teaching methods. (c) Classroom instruction shall include job tasks associated with lead-related construction project design as follows: (1) Interpretation of inspection reports; (2) Selection of clearance testing methods as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; (3) Selection of hazardous waste segregation, testing and disposal methods; (4) Development and modification of project design specifications including but not limited to: (A) Working with other consultants such as industrial hygienists, construction journeymen, engineers, and housing specialists; (B) Prescriptive and performance specifications; (C) Drawing preparation, including interpretation of as-built drawings; (D) Structure modification; (E) Special design procedures for occupied buildings, including strategies for occupant education, occupant and furniture relocation, and exposure minimization; (F) Selection of abatement and interim control methods; (G) Cost estimation for budgeting purposes, including strategies for cost reduction; and (H) Scheduling parameters, including resident notification, building access, warning signs, and occupant disruption minimization. (d) Participation in a simulated field visit associated with developing lead-related construction project designs which includes: (1) Building walk-through for development of project design; and (2) Classroom discussion of a simulated field visit. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35065. Course Requirements. (a) A lead-related construction work course shall consist of a minimum of 24 contact hours which includes methodology requirements specified in subsection 35065(b), hands-on training, as specified in subsection 35065(c), classroom instruction, as specified in subsection 35065(d), and a demonstration of respirator fit testing as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1. (b) At least 12 of the 24 required contact hours shall be taught using interactive/participatory teaching methods, which includes at least ten contact hours of hands-on training. (c) Hands-on training shall include performance of tasks associated with: (1) Exposure assessment including air monitoring and worker protection practices including personal protective equipment as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1; and (2) Lead-related construction work, including, construction and use of containment and barrier systems for at least two worksite preparation levels, removal methods, interim control methods, waste disposal, use of high efficiency particulate air (HEPA) vacuums, electrical and ventilation system lockout, clean-up, and personal hygiene. (d) Classroom instruction shall include: (1) At least one contact hour of regulatory requirements as specified in: (A) Injury and Illness Prevention Program requirements set forth in Title 8, California Code of Regulations, sections 1509 and 3203; (B) California's Construction Safety Orders set forth in Title 8, California Code of Regulations, section 1532.1; (C) Standards for hazard communication in the work place set forth in the "Clear and Reasonable Warnings," Title 22, California Code of Regulations, subsections 12601(c) and (d) and in "Hazard Communication," Title 8, California Code of Regulations, section 5194; and (D) Work practice standards set forth in Title 17, California Code of Regulations, sections 36000 and 36100. (2) At least one contact hour of background information on lead, including: (A) Identification of sources of environmental lead contamination such as surface dust, soil, water, air, and food; (B) History of uses and locations of lead and leaded paint in buildings; (C) Lead contaminated dust and lead-based and paint properties; and (D) Health effects related to lead exposure, including but not limited to: 1. Pathways of exposure in children and adults; 2. Dose-response relationships and blood lead levels in children and adults; 3. Effects on the nervous, reproductive (male and female), musculo-skeletal, cardiovascular, and blood-forming systems and kidneys; 4. Different effects on children and adults, including women during pregnancy; 5. Symptoms and diagnosis of poisoning in children and adults and DHS-reportable blood lead levels; and 6. Medical treatment for lead poisoning, including chelation therapy. (3) At least two contact hours on respiratory protection and personal protective equipment, including: (A) Elements of a respiratory protection program set forth in Title 8, California Code of Regulations, sections 5141 and 5144 and Occupational Safety and Health Administration (OSHA) respirator requirements set forth in 29 Code of Federal Regulations, section 1910.134 (1998); (B) Classes and characteristics of respirators; (C) Limitations of respirators; (D) Proper selection, inspection, donning, doffing, use, maintenance, and storage procedures for respirators; (E) Methods for field testing the face piece seal (user seal check procedures); (F) Qualitative and quantitative fit testing procedures; (G) Factors that alter respirator fit, e.g. facial hair; (H) Selection and use of personal protective clothing; (I) Storage and handling of non-disposable clothing; and (4) At least eight contact hours on job tasks associated with lead-related construction including: (A) Tasks as described in, "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision as follows: 1. Sampling methods for paint, dust, and soil; 2. Construction and use of containment and barrier systems for all interior and exterior worksite preparation levels; 3. Interior and exterior leaded paint, soil and dust abatement methods (including chemical, enclosure, hand, mechanical, blasting, encapsulation), and interim control methods; 4. Use of administrative and engineering controls; and 5. Clean-up techniques (including high efficiency particulate air (HEPA) vacuums); (B) Construction, use and maintenance of containment and barrier systems; (C) Warning signs and their placement; (D) Electrical and ventilation systems lockout; (E) Hazardous and non-hazardous waste characterization and disposal; (F) Personal hygiene, including entry and exit procedures for the work area, use of showers, avoidance of eating, drinking, smoking, chewing, and applying cosmetics in the work or changing area, avoidance of take-home exposures; and (G) Identification and prevention of hazards as follows: 1. Emergency procedures for sudden releases; and 2. Electrical, heat, stress, fire, explosion and other hazards, chemical air contaminants, slips, trips, falls and disturbances of friable asbestos. (5) Medical monitoring requirements as specified in the Construction Safety Orders, California Code of Regulations, title 8, section 1532.1, including: (A) Discussion of the need for medical monitoring of lead toxicity and disclosure of medical history for lead-related construction work; and (B) Treatment of lead poisoning cases, including medical removal procedures and the issue involved in selecting medical services. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35066. Course Requirements. (a) A lead-related construction supplemental supervision course shall consist of a minimum of 16 contact hours which includes methodology requirements specified in subsection 35066(b), hands-on training, as specified in section 35066(c), and classroom instruction, as specified in subsection 35066(d). (b) At least four of the 16 required contact hours shall be taught using interactive/participatory teaching methods, which includes at least one contact hour of hands-on training. (c) Hands-on training shall include performance of tasks associated with: (1) Exposure assessment including paint chip collection and air monitoring as specified in the Construction Safety Orders, Title 8, California Code of Regulations, section 1532.1; and (2) Clearance inspections such as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision. (d) Classroom instruction shall include: (1) Regulatory requirements as specified in: (A) California's Construction Safety Orders set forth in Title 8, California Code of Regulations, section 1532.1; (B) Section 35055(a)(2)(A) and (B); and (C) Section 35057(d)(1)(C). (2) Job tasks associated with sample collection and analysis procedures as specified in section 35057(d)(3). (3) At least five contact hours on job tasks associated with lead-related construction as specified in section 35057(d)(4). (4) Supervision and project monitoring job tasks associated with lead-related construction project design as specified in 35057(d)(5). (5) Supervision and project monitoring issues as specified in 35057(d)(6)(7) and (8). (6) Discussion of the roles and responsibilities of the interim certified individual as specified in 35055(a)(4). Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35067. Course Requirements. (a) A lead-related construction certified industrial hygienist course shall consist of a minimum of 24 contact hours which includes methodology requirements specified in subsection 35067(b), hands-on training, as specified in subsection 35067(c), and classroom instruction, as specified in subsection 35067(d). (b) At least eight of the 24 required contact hours shall be hands-on training. (c) Hands-on training shall include performance of tasks associated with: (1) Inspection and hazard assessment techniques as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision. (2) Simulated field visit associated with lead-related construction inspection and assessment which includes: (A) Walk-through building inspection; (B) Discussion of data collection, including sample location determination; and (C) Practice with an X-ray Fluorescence (XRF) analyzer. (3) Simulated field visit associated with developing lead-related construction project designs which includes: (A) Building walk-through for development of project design; and (B) On-site discussion of project design. (d) Classroom instruction shall include: (1) Background information on lead, including: (A) Identification of sources of environmental lead such as surface dust, soil, water, air, and food; (B) History of uses and locations of lead and leaded paint in buildings; (C) Lead dust and paint characteristics; and (D) Summary of lead abatement control options, including interim controls. (2) Relevant federal, state and local regulatory requirements: (A) Requirements for the identification, management, transport, record keeping, and disposal of hazardous waste set forth in Title 22, California Code of Regulations, Division 4.5, Chapters 10, 11, 12, 13, and 18, and Health and Safety Code section 25163, subdivision (c), and Chapter 6.5, Article 10.8; (B) Ambient Air Quality Standards for lead set forth in Title 17, California Code of Regulations, sections 70100 and 70200; (C) California's Construction Safety Orders set forth in Title 8, California Code of Regulations, section 1532.1; (D) National Emission Standards for Hazardous Air Pollutants set forth in 40 Code of Federal Regulations, section 50.12 (1992); (E) Relevant State Contractor Licensing Board requirements for conducting work as a contractor set forth in section 7026 and following of the Business and Professions Code; (F) Permitting requirements for lower risk treatment activities set forth in Health and Safety Code, Chapter 6.5, Article 9, sections 25200.3, 25201.5, and Title 22, California Code of Regulations, Division 4.5, Chapter 45; and (G) Work practice requirements set forth in Title 17, California Code of Regulations, sections 36000 and 36100. (3) Federal guidelines as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision. (4) Roles and responsibilities of local health officials versus private sector Inspector/Assessors when conducting lead hazard assessments. (5) Job tasks associated with lead hazard inspection procedures as follows: (A) Review and interpretation of previous inspection records; (B) Inspection plan development, including notification of property owners and occupants, building access, use of warning signs, and disruption minimization; (C) Hazard communication with property owners, occupants, and neighbors relative to the reduction or elimination of sources of lead at the job site such as paint, dust, soil, water, imported ceramic pottery, home remedies, or occupational take-home sources; (D) Visual inspections and clearance inspections; (E) Investigation protocol for assessing multiple sources of lead exposure; (F) Sample collection including equipment, procedures, quality assurance and contamination factors before, during and after abatement, as described in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; (G) Sample analysis, including selection of an EPA recognized laboratory to test paint, dust, soil samples and other media and quality assurance procedures; and (H) Post-inspection procedures and written reports. (6) Job tasks associated with lead hazard risk assessment as follows: (A) HUD protocol for risk assessment and interim controls as specified in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; (B) Assessment of leaded paint surface damage, including disturbance potential of lead-related construction activities; (C) Child accessibility to lead-based paint surfaces; and (D) Public and lead-related construction personnel health considerations, including medical confidentiality. (7) Lead-based paint abatement techniques in residential and public, buildings as follows: (A) Abatement options, including interim controls; (B) Clean-up and disposal procedures, contamination prevention and dust minimization, including high efficiency particulate air (HEPA) vacuums as described in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; and (C) Abatement and interim controls cost estimation. (8) Inspector/Assessor qualifications, responsibilities, legal obligations and conflicts of interest. (9) Insurance issues relating to lead-related construction including: (A) Workers' compensation coverage and exclusions; and (B) Liability insurance, claims-made and occurrence policies, and environmental and pollution liability policy clauses, and bonding. (10) Job tasks associated with lead-related construction including, but not not limited to, the following: (A) Abatement as a portion of a renovation project; (B) Notification of other contractors working at the construction site; (C) Safe work practices as follows: 1. Construction and maintenance of containment barriers; 2. Warning signs and their placement; and 3. Electrical and ventilation systems lockout; (D) Meeting housing codes and standards; (E) Procedures for occupied buildings, including strategies for occupant education, occupant and furniture relocation, and exposure minimization; (F) Development of detailed schedules to comply with project design requirements and execution of tasks, including but not limited to, resident notification, building access, warning signs, and occupant disruption minimization; and (G) Administrative tasks associated with supervision and project monitoring: 1. Contract specifications, preparation and administration; 2. Cost estimation, including strategies for cost reduction. (11) Supervision and project monitoring job tasks associated with project design as follows: (A) Review of inspection reports; (B) Performance of clearance testing methods as described in "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S. Department of Housing and Urban Development, June 1995, or most recent revision; and (C) Performance of hazardous waste segregation, testing, and disposal. (12) Conflicts of interest related to the performance of supervision, inspection, and project monitoring tasks. (13) Job tasks associated with lead-related construction project design as follows: (A) Development and modification of project design specifications: 1. Working with other consultants such as industrial hygienists, construction journeymen, engineers, and housing specialists; 2. Prescriptive and performance specifications; 3. Drawing preparation, including interpretation of as-built drawings; 4. Structure modification; 5. Special design procedures for occupied buildings, including strategies for occupant education, occupant and furniture relocation, and exposure minimization; 6. Selection of abatement and interim control methods; 7. Cost estimation for budgeting purposes, including strategies for cost reduction; and 8. Scheduling parameters, including resident notification, building access, warning signs, and occupant disruption minimization. (14) Classroom discussion of simulated field visits. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35070. Continuing Education for Workers Requirements. (a) Continuing education for workers shall only be provided by an accredited training provider approved by the Department to offer the lead-related construction work course. (b) Continuing education instruction shall be designed to increase or enhance skills and knowledge necessary to perform the job tasks and job functions associated with certification and shall be offered in minimum increments of one contact hour. (c) At least 40% of continuing education instruction for workers shall be taught using interactive/participatory teaching methods. (d) Continuing education topics shall include: (1) An overview of safety practices relevant to tasks conducted by certified lead workers; (2) An update on federal, state, or local statutes or regulations relevant to tasks conducted by certified lead workers; and (3) An update on new lead-related construction techniques or technologies relevant to tasks conducted by certified lead workers. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35072. General Continuing Education Requirements. (a) General continuing education shall only be provided by an accredited training provider approved to offer one of the following lead-related construction courses: inspection and assessment, supervision and project monitoring, supplemental supervision and project monitoring, project design, or Certified Industrial Hygienist. (b) General continuing education instruction shall be designed to increase or enhance skills and knowledge necessary to perform the job tasks and job functions associated with certification or interim certification and shall be offered in minimum increments of one contact hour. (c) At least 25% of general continuing education instruction shall be taught using interactive/participatory teaching methods. (d) General continuing education topics shall include: (1) An overview of safety practices in lead-related construction; (2) An update on federal, state, or local statutes or regulations relevant to tasks conducted by certified lead inspector/assessors, project designers, project monitors, and supervisors; and (3) An update on lead-related construction techniques or technologies relevant to tasks conducted by certified lead inspector/assessors, project designers, project monitors, and supervisors. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35076. Application Requirements. (a) A complete application for provisional accreditation or provisional course approval shall consist of a completed DHS Form 8487 (12/97), Application for Training Provider Accreditation and Course Approval, and required documentation as follows: (1) Type of application: (A) Accreditation; or (B) Course Approval. (2) Type of course or training applicant seeks to provide: (A) Lead-related construction inspection and assessment course; (B) Lead-related construction supervision and project monitoring course; (C) Lead-related construction project design course; (D) Lead-related construction work course; (E) Lead-related construction supplemental supervision course; (F) Lead-related construction Certified Industrial Hygienist course; (G) Lead-related construction general continuing education and number of contact hours; or (H) Lead-related construction continuing education for workers and number of contact hours. (3) Applicant information: (A) Training provider's name, street address (principal place of business), mailing address (if different from street address), telephone number, and fax number, if applicable; and (B) Training Director's name, street address and mailing address (if different from street address). (4) Operational information: (A) Description of training facility (including classroom and field site), equipment, and equipment storage; (B) Description of record keeping procedures; (C) One copy of the entire course or continuing education instruction curriculum, including, but not limited to, learning objectives, documentation of the length and sequence of topics to be covered during the course(s) or continuing education instruction, student and instructor manuals, handouts, quizzes, and homework; (D) Student-to-instructor ratio during hands-on training; (E) Description of the amount and type of hands-on training; (F) Description of the teaching methods to be used for each major topic and for hands-on training; (G) Description of the audio/visual aids to be used for each major topic; and (H) List of languages, other than English, in which training will be offered. (5) Personnel information: (A) Documentation of Training Director's qualifications pursuant to paragraphs 35053(a)(1)-(4); (B) Name(s) of instructor(s); (C) Course(s) or topic(s) instructor(s) will teach; (D) Documentation of instructors' qualifications pursuant to paragraphs 35053(b)(1)-(4); (E) Name(s) of guest instructor(s); (F) Course(s) or topic(s) guest instructor(s) will teach; and (G) Documentation of guest instructors' qualifications pursuant to subsection 35053(d). (6) Final examination information: (A) List of skills and knowledge to be tested; (B) One copy of the entire final examination and correct answers, including demonstration testing criteria and protocol; (C) One copy of the student final examination scoresheet or other record; and (D) One copy of each retake examination and correct answers. (7) Compliance with other relevant regulations: (A) Documentation of approval under Section 94915, or exemption under Section 94739, or disclosure under Section 94931, of the California Education Code, as applicable; and (B) Documentation of compliance with any radiological licensing, storage, and use requirements of the Department of Health Services Radiologic Health Branch set forth in Title 17, California Code of Regulations, Division 1, Chapter 5, Subchapter 4, 4.5, and 4.6; and (C) Documentation of accreditation by other state or federal agencies, if applicable. (8) Applicant's name, printed or typed, signature, title, and date, verifying under penalty of perjury, that all information contained on and submitted with DHS Form 8487 (12/97), Application for Training Provider Accreditation, is true and correct. (b) A training provider seeking to renew accreditation shall submit a completed DHS Form 8557 (12/97) Renewal of Training Provider Accreditation and Course Approval, and required documentation as follows: (1) Type of course(s) or training applicant is currently approved to offer: (A) Lead-related construction inspection and assessment course; (B) Lead-related construction supervision and project monitoring course; (C) Lead-related construction project design course; (D) Lead-related construction work course; (E) Lead-related construction supplemental supervision course; (F) Lead-related construction Certified Industrial Hygienist course; (G) Lead-related construction general continuing education and number of contact hours; or (H) Lead-related construction continuing education for workers and number of contact hours. (2) Applicant information: (A) Training provider's name, street address (principal place of business), mailing address (if different from street address), telephone number, and fax number, if applicable; (B) Training Director's name, street address and mailing address (if different from street address); (C) Accreditation Number; (D) Current course or continuing education instruction number(s); and (3) A description of the training facility (including classroom and field site), equipment, and equipment storage, if changed since the original application for accreditation; (4) Personnel information: (A) Documentation of instructor's qualifications pursuant to paragraphs 35053(b)(1)-(4); (B) Name(s) of instructor(s); (C) Course(s) or topic(s) instructor(s) will teach; (D) Name(s) of guest instructor(s); (E) Course(s) or topic(s) guest instructor(s) will teach; and (F) Documentation of guest instructors' qualifications pursuant to subsection 35053(d). (5) Final examination information: (A) One copy of the entire final examination and correct answers, including demonstration testing; (B) One copy of the student examination scoresheet or other record; and (C) One copy of each retake examination and correct answers. (6) Compliance with other relevant regulations: (A) Documentation of approval under Section 94915, or exemption under Section 64739, or disclosure under Section 94931, of the California Education Code, as applicable; and (B) Documentation of compliance with any radiological licensing, storage, and use requirements of the Department of Health Services Radiologic Health Branch set forth in Title 17, California Code of Regulations, Division 1, Chapter 5, Subchapter 4, 4.5, and 4.6; and (C) Documentation of accreditation by other state or federal agencies, if applicable. (7) Applicant's name, printed or typed, signature, title, and date, verifying under penalty of perjury, that all information contained on and submitted with DHS Form 8557 (12/97), Application for Renewal of Training Provider Accreditation, is true and correct. (c) An accredited training provider seeking DHS approval to offer an additional course shall submit a completed DHS Form 8487 (12/97), Application for Training Provider Accreditation, and required documentation, except an applicant need not re-submit unchanged information and documentation that was submitted with the original application for accreditation. (d) An accredited training provider shall notify the Department within 30 calendar days of a change of address. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35078. Accreditation Procedures. (a) Within 30 calendar days of receipt of an application for accreditation, renewal, or course approval, the Department shall inform the applicant in writing that the application is either complete or incomplete and what additional information documentation is required to complete the application. (1) If an applicant submits required information or documentation within 30 days from the issuance date of the notice of incompleteness, the Department shall issue a written notice of completeness. (2) If an applicant fails to submit required information or documentation within 30 days from the issuance date of the notice of incompleteness, the application shall be deemed to be abandoned and reapplication shall be required. (3) An application may be withdrawn by written request to the Department. (b) Within 60 calendar days from the issuance date of the notice of completeness, the Department shall grant or deny provisional accreditation, renewal, or provisional course approval. (1) If denied, the Department shall state, in writing, the reasons for denial. (2) If granted, a written notice containing an accreditation number and course number(s), shall be sent to the applicant. (A) The issuance date of the written notice shall be the effective date of provisional accreditation, renewal, or provisional course approval. (B) Upon issuance of the written notice granting provisional accreditation or course approval, an accredited training provider may commence offering a DHS-approved course(s). (c) Processing Time: (1) Pursuant to the Permit Reform Act, Government Code section 15376, the minimum, median, and maximum elapsed time to process an application for accreditation, renewal, or course approval, and issue a written notification of approval shall be as follows: (A) Minimum: 15 calendar days. (B) Median: 30 calendar days. (C) Maximum: 260 calendar days. (2) The Department may exceed the maximum time as provided above if the applicant requests in writing a delay of consideration of the application or issuance of a written notification of provisional accreditation, renewal, or provisional course approval. (d) In making a determination of whether to grant or deny provisional accreditation, renewal, or provisional course approval, the Department may take into consideration various factors, including, but not limited to the following: (1) Failure to satisfy eligibility requirements for accreditation; (2) Failure to satisfy eligibility requirements for course approval; (3) Past history of revocation of accreditation; (4) False statements in the application; or (5) Failure to provide further required documentation or information requested by the Department. (e) Provisional status shall be removed if an accreditation audit indicates that requirements for accreditation are satisfied. (1) A provisionally accredited training provider shall permit the Department to conduct an accreditation audit without charge to the Department. Advance notice shall not be required prior to conducting an accreditation audit. (2) An accreditation audit shall be conducted within 365 calendar days following the issuance of provisional accreditation. (3) An accreditation audit shall be performed on site and shall include, but not be limited to, a review of: records, including Course Completion Forms and attendance records; facilities; instructional curriculum; examination design, administration and security procedures, and results, including those of demonstration testing; classroom instruction; audio-visual materials; course content; and coverage. (f) Provisional status shall be removed if a course audit indicates that requirements for DHS course approval are satisfied. (1) A provisionally accredited or accredited training provider shall permit the Department to conduct a course audit without charge to the Department. Advance notice shall not be required prior to conducting a course audit. (2) A course audit shall be conducted within 365 calendar days following the issuance of provisional course approval. (3) A course audit shall be performed on site and shall include, but not be limited to, a review of: instructional curriculum; examination design, administration and security procedures, and results, including those of demonstration testing; classroom instruction; audio-visual materials, course content; and coverage. (g) If an accreditation or course audit indicates that requirements for accreditation or course approval are not satisfied, the Department shall issue, within seven working days of completion of the accreditation or course audit, written notice of required modifications. (1) Written notice shall include an explanation of the Department's audit process, a statement of inadequacies found upon audit, possible actions that may be imposed, a description of procedures available if the training provider desires an opportunity to explain or justify the findings of the audit, steps that must be taken to correct any inadequacies, and any applicable deadlines. (h) If an accreditation or course audit indicates that requirements for accreditation or course approval are satisfied, a written notice removing provisional accreditation or provisional course approval shall be issued within seven working days after completion of an accreditation or course audit. (1) Accreditation shall be valid for a period of three years and shall not be transferable. (2) Renewal applications shall be required at least 120 calendar days prior to the expiration date of accreditation. (i) An accredited training provider shall permit the Department to conduct on-site investigations at any time. Advance notice shall not be required. On-site investigations may include, but are not limited to, a review of: records, including Course Completion Forms and attendance records; facilities; training curriculum; examination design, administration and security procedures, and results, including those of demonstration testing; classroom instruction; audio-visual materials; course content; and coverage. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35080. Action to Suspend or Revoke Accreditation, Provisional Accreditation, or Course Approval. (a) Accreditation, provisional accreditation, or course approval may be suspended or revoked by the Department for: (1) Failure to adhere to the standards and requirements for accreditation, provisional accreditation, or course approval; (2) Failure to properly administer, score, or maintain security of a required examination, examination answers, or results; (3) Failure to maintain approval or authority to operate granted by the Council For Private Postsecondary and Vocational Education; (4) Falsification of accreditation records, instructor qualifications, or other accreditation information; (5) Failure to provide the required course contact hours, course content, or coverage; (6) Misrepresentation of the contents of a course; (7) Failure to submit required information or notifications in a timely manner; (8) Failure to maintain required records; (9) Failure to comply with relevant federal, state, or local leaded paint statutes or regulations; (10) Failure to make modifications required by the Department within 30 days from the issuance date of the written notice of required modifications; or (11) Other conditions revealed by any means which would warrant suspension or revocation. (b) Suspension or revocation and an appeal of any suspension or revocation shall be conducted in compliance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. (c) Prior to suspension or revocation, an accredited or provisionally accredited training provider will be given an opportunity, except in the case of willful violation or threat to public health and safety, to remedy deficiencies that may result in suspension or revocation. (1) The accredited or provisionally accredited training provider shall be given a statement which includes the Department's findings, an explanation of what the accredited or provisionally accredited training provider must do to comply with the regulations, and the time period in which the accredited or provisionally accredited training provider must act. (2) The accredited or provisionally accredited training provider must remedy the deficiencies within a reasonable time specified by the Department which shall be no more than 30 calendar days after the issuance date of the statement of deficiencies. (d) A training provider shall not offer course training when accreditation, provisional accreditation, or DHS course approval is suspended or revoked, except, the Department, at its discretion, may permit the training provider to continue to offer training to students already enrolled. If training is not permitted to continue, a refund of all tuition and other charges shall be provided to students already enrolled, if applicable. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35081. Representation of Certification Status. Unless certified pursuant to the requirements of this chapter, no person shall represent themselves as, or do business as, a certified lead-inspector/assessor, certified lead project designer, certified lead project monitor, certified lead supervisor, or certified lead worker. Note: Authority cited: Sections 105250(a) and (b) and 124160(b), Health and Safety Code. Reference: Sections 16240 and 17200, Business and Professions Code. s 35082. Application Timeliness. (a) Applicants for certification or interim certification shall apply to the Department within one year from the issuance date of DHS Form 8493 (12/97), Course Completion Form. (b) Applicants failing to apply within one year from the issuance date of DHS Form 8493 (12/97), Course Completion Form, shall complete a minimum of seven contact hours of: (1) General continuing education in order to be eligible to apply for inspector/assessor, project designer and/or project monitor certification or interim certification; (2) General continuing education or continuing education for workers in order to be eligible to apply for supervisor certification or interim certification; or (3) Continuing education for workers in order to be eligible to apply for worker certification. (c) Applicants failing to apply within three years from the issuance date of DHS Form 8493 (12/97), Course Completion Form, shall retake the appropriate DHS-Approved course to be eligible to apply for certification. (d) Applications for certification or interim certification renewal shall be submitted at least 120 calendar days prior to the expiration date indicated on the certificate or interim certificate. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35083. Inspector/Assessor. To qualify for certification as a certified lead inspector/assessor, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and meet the following minimum eligibility requirements: (a) Possess DHS Form 8493 (12/97), Course Completion Form, from a lead-related construction inspection and assessment course; and (b) Pass the lead certification examination for inspector/assessors offered by the Department; and either: (1) Have a bachelor's degree in biological, chemical, or physical science, or a related field and one year of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting environmental inspections and assessing environmental health, occupational safety, or environmental hazards, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or (2) Have an associate degree in biological, chemical, or physical science, or a related field, or 20 semester or 30 quarter units in biological, chemical, or physical science, or a related field, and two years of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting environmental inspections and assessing environmental health, occupational safety, or environmental hazards, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or (3) Have a high school diploma or equivalent and at least three years of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting environmental inspections and assessing environmental health, occupational safety, or environmental hazards, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or (4) Be a certified industrial hygienist and possess DHS Form 8493 (12/97), Course Completion Form, from a lead-related construction Certified Industrial Hygienist course. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35085. Supervisor. To qualify for certification as a certified lead supervisor, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and meet the following minimum eligibility requirements: (a) Possess DHS Form 8493 (12/97), Course Completion Form, from a lead-related construction supervision and project monitoring course or possess DHS Forms 8493 (12/97), Course Completion Forms, from a lead-related construction work course and a lead-related construction supplemental supervision and project monitoring course; and (b) Pass the lead certification examination for supervisors offered by the Department; and either: (1) Have one year of experience as a certified lead worker; or (2) Have two years of experience in lead-related construction or a related field (e.g., asbestos, the building trades, or environmental remediation work) conducting environmental health, occupational safety, or environmental hazard control. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35087. Project Monitor. To qualify for certification as a certified lead project monitor, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and meet the following minimum eligibility requirements: (a) Possess DHS Form 8493 (12/97), Course Completion Form, from a lead-related construction supervision and project monitoring course or possess DHS Forms 8493 (12/97), Course Completion Forms, from a lead-related construction work course and a lead-related construction supplemental supervision and project monitoring course; and: (b) Pass the lead certification examination for project monitors offered by the Department; and either: (1) Have a bachelor's degree in biological, chemical, or physical science, or a related field and one year of experience in lead-related construction or a related field (e.g., asbestos, environmental remediation work, or other construction) conducting or monitoring environmental health, occupational safety, or environmental hazards, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or (2) Have an associate degree in biological, chemical, or physical science, or a related field, or 20 semester or 30 quarter units in biological, chemical, or physical science, or a related field and one year of experience as a certified lead supervisor or two years of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting or monitoring environmental health, occupational safety, or environmental hazard reduction projects or designing projects in environmental health, occupational safety, or environmental hazard reduction; or (3) Have a high school diploma or equivalent plus two years experience as a certified lead supervisor, or three years of experience in lead-related construction or a related field (e.g., asbestos, or environmental remediation work) conducting or monitoring environmental health, occupational safety or environmental hazard reduction projects, or designing projects in environmental health, occupational safety, or environmental hazard reduction; or (4) Be a certified industrial hygienist and possess DHS Form 8493 (12/97), Course Completion Form, from a lead-related construction Certified Industrial Hygienist course. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35089. Project Designer. To qualify for certification as a certified lead project designer, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and meet the following minimum eligibility requirements; (a) Possess DHS Form 8493 (12/97), Course Completion Forms, from a lead-related construction supervision and project monitoring course issued within 3 years prior to the application date for certification as a project designer and from a lead-related construction project design course or be a certified lead supervisor or certified lead project monitor and possess DHS Form 8493 (12/97), Course Completion Form, from a lead-related construction project design course; and (b) Pass the lead certification examination for project designers offered by the Department; and either: (1) Have a bachelor's degree in engineering, architecture, or a related profession, and one year of experience in building construction and design or a related field; or (2) Have an associate degree or higher in building construction, building design or a related field, or 20 semester or 30 quarter units in building construction, building design or a related field, and two years of experience in building construction and design or a related field; or (3) Have a high school diploma or equivalent plus four years of experience in building construction and design or a related field; or (4) Be a certified industrial hygienist and posses DHS Form 8493 (12/97), Course Completion Form, from a lead-related construction Certified Industrial Hygienist course. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35091. Worker. To qualify for certification as a certified lead worker, an individual shall comply with all applicable requirements specified in sections 35095 and 35096 and possess DHS Form 8493 (12/97), Course Completion Form, from a lead-related construction work course. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35093. Interim Certification and Renewal. (a) Applications for interim certification shall be accepted through August 30, 1998. Applications for renewal of interim certification shall be accepted through December 31, 1998. Individuals who possess interim certificates with expiration dates after April 30, 1999 shall not be eligible to renew their interim certificate(s) and must take and pass the Department's certification examination to be eligible to apply for certification. (b) To qualify for interim certification as a lead inspector/assessor, an individual shall comply with all applicable requirements specified in sections 35083, 35095 and 35096, except for the certification examination requirements specified in subsection 35083(b). (c) To qualify for interim certification as a lead supervisor an individual shall comply with all applicable requirements specified in sections 35085, 35095 and 35096, except for the certification examination requirements specified in subsection 35085(b). (d) To qualify for interim certification as a lead project monitor an individual shall comply with all applicable requirements specified in sections 35087, 35095 and 35096, except for the certification examination requirements specified in subsection 35087(b). (e) To qualify for interim certification as a lead project designer an individual shall comply with all applicable requirements specified in sections 35089, 35095 and 35096, except for the certification examination requirements specified in subsection 35089(b). (f) Individuals failing to apply for renewal within one year after the expiration date of an interim certificate, shall comply with applicable subsections (b) of sections 35083, 35085, 35087, and 35089, and subsections 35095(b), and 35096(f)(1) to be eligible to apply for certification. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35095. Application Requirements. (a) A complete application for certification or interim certification shall consist of a non-refundable $75.00 application fee per certificate or interim certificate requested and a completed DHS Form 8488 (12/97), Application for Lead Certification, with required documentation: (1) Type of certification or interim certification requested and amount of fee(s) paid: (A) Certified lead inspector/assessor; (B) Certified lead supervisor; (C) Certified lead project designer; (D) Certified lead project monitor; or (E) Certified lead worker. (2) Applicant's name, residence address, (and mailing address, if different), telephone number, date of birth, gender, race/ethnicity and photo identification number with a description of the photo identification document. (3) Documentation of applicant's education, training, and experience, including: (A) Original Course Completion Form, DHS Form 8493 (12/97), for a course issued by an accredited training provider. (B) A Proof of Experience DHS Form 8539 (12/97) for each employer providing documentation of completion of lead-related construction or other applicable experience. Each Proof of Experience form shall contain: 1. The applicant's name; 2. The name and address of the applicant's employer; 3. The name and telephone number of the applicant's supervisor, or the names and phone numbers of three client references, if self-employed; 4. The applicant's employment dates; 5. Descriptions of specific lead-related construction or other applicable activities performed; 6. Estimated percentage of time associated with lead-related construction or other applicable activities; and 7. The name, title, and signature of the applicant's supervisor or employer, or the applicant's signature, if self-employed, verifying, under penalty of perjury, that the information contained on the Proof of Experience DHS Form 8539 (12/97) is true and correct. (C) Evidence of completion of postsecondary education, such as a transcript or diploma. (D) Certified Industrial Hygienists, who possess a Course Completion Form from a lead-related construction Certified Industrial Hygienist course, may substitute a copy of their American Board of Industrial Hygiene Certificate, or its equivalent, for evidence of both experience and postsecondary education documentation. (4) Two passport style, 1 inch by 1 inch, photographs. (5) Applicant's signature and date signed, verifying, under penalty of perjury, that all information contained on and submitted with DHS Form 8488 (12/97), Application for Lead Certification, is true and correct. (b) A complete application for certification or interim certification renewal shall consist of a completed DHS Form 8553 (12/97), Renewal of Lead Certification, and a non-refundable seventy-five dollar application fee for each certificate or interim certificate renewal requested with the following required documentation: (1) If not submitted to the Department in the previous year, an original Course Completion Form DHS Form 8493 (12/97) issued by an accredited training provider for: (A) General continuing education, if the application is for renewal of inspector/assessor, project designer, or project monitor certification or interim certification; or (B) General continuing education or continuing education for workers, if the application is for renewal of supervisor certification or interim certification; or (C) Continuing education for workers, if the application is for renewal of worker certification. (2) Documentation specified in sections 35095(a)(2), and 35095(a)(5); and (3) Certificate or interim certificate number(s), expiration date(s) and amounts of fee(s) paid. (c) Certified or interim certified individuals shall notify the Department within 30 calendar days of a change of address. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35096. Certification, Interim Certification, and Renewal Procedures. (a) Within 30 calendar days of receipt of an application for certification, interim certification or renewal, the Department shall inform the applicant in writing that the application is either complete or incomplete and what additional information or documentation is required to complete the application. (1) If an applicant submits required information or documentation within 30 days from the issuance date of the notice of incompleteness, the Department shall issue a written notice of completeness. (2) If an applicant fails to submit required information or documentation within 180 days from the issuance date of the notice of incompleteness, the application shall be deemed to be abandoned and reapplication shall be required. (3) An application may be withdrawn or amended only by written request to the Department. (b) Within 60 calendar days from the issuance date of the notice of completeness, the Department shall grant or deny interim certification, renewal, or permission to sit for the Department's lead certification examination in the certification discipline applied for. (1) If denied, the Department shall state, in writing, the reasons for denial. (2) If granted, an interim certificate, renewal, or permission notice shall be sent to the applicant and the issuance date of the interim certificate, renewal, or permission notice shall be the effective date of interim certification, renewal, or permission notice. (c) Within 30 calendar days from the date an individual passes the lead certification examination in the certification discipline applied for, the Department shall grant or deny certification. (1) Individuals who fail to pass the lead certification examination in the certification discipline applied for within 180 days from the issuance date of the permission notice, shall retake the DHS-approved lead-related construction course in that discipline, and comply with Section 35095, excepting subsections 35095(a)(3)(B), 35095(a)(3)(C), 35095(a)(3)(D), and 35095(a)(4), to be eligible to re-apply for permission to sit for the lead certification examination. (2) An individual shall take the lead certification examination no more than three times within 180 days from the issuance date of the permission notice. (d) Processing Time: (1) Pursuant to the Permit Reform Act, Government Code section 15376, the minimum, median, and maximum elapsed time to process a completed application for a certificate or interim certificate and issue a written notification of approval shall be as follows: (A) Minimum: 15 calendar days. (B) Median: 120 calendar days. (C) Maximum: 270 calendar days. (2) The Department may exceed the maximum time as provided above if the applicant requests in writing a delay of consideration of the application or issuance of a certificate or interim certificate. (e) In making a determination of whether to grant, deny, or renew certification or interim certification, or permission to sit for a lead certification examination, the Department may take into consideration various factors, including, but not limited to, the following: (1) Failure to satisfy eligibility requirements for certification or interim certification; (2) Type and amount of lead-related construction training; (3) Failure to provide further required documentation or information requested by the Department; (4) Past history of citations or violations of existing regulations or standards; (5) Past history of revocation of a Certificate or Interim Certificate; or (6) False or misleading statements in the application. (f) Certification or interim certification shall be non-transferable and shall be effective for a period of one year. (1) Certified or interim certified individuals shall complete a minimum of seven contact hours of continuing education instruction every two years to be eligible to apply for certification or interim certification renewal. (2) Certified individuals applying for renewal more than three years after the expiration date of the certificate or interim certificate shall retake the required DHS-approved lead-related construction course and comply with section 35095(a)(3)(A), 35095(b) to be eligible to apply for certification renewal. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35097. Action to Suspend or Revoke Certification or Interim Certification. (a) Certification or interim certification may be suspended or revoked by the Department for: (1) Any false statement in the application; (2) Violations of relevant local, state, or federal statutes or regulations; (3) Misrepresentation, failure to disclose relevant facts, fraud, or issuance by mistake; (4) Failure to comply with California Code of Regulations, Title 17, sections 36000 or 36100; or (5) Failure to comply with any relevant regulation or order of the Department. (b) Suspension or revocation and an appeal of any suspension or revocation shall be conducted in compliance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. (c) Prior to suspension or revocation, a certified or interim certified individual shall be given an opportunity, except in the case of willful violation or threat to public health and safety, to remedy deficiencies that may result in suspension or revocation. (1) The certified or interim certified individual shall be given a statement which includes the Department's findings, an explanation of what the certified or interim certified individual must do to comply with the regulations, and the time period in which the certified or interim certified individual shall act. (2) The certified or interim certified individual must remedy the deficiencies within a reasonable time specified by the Department which shall be no more than 30 calendar days after the issuance date of the statement of deficiencies. (d) Any individual whose certification or interim certification has been suspended or revoked shall not be eligible to perform activities which require DHS lead certification. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 35099. Funding for Enforcement. The amount of $100,000.00 shall be allocated to the Division of Occupational Safety and Health annually to be expended for the division's costs of enforcing compliance with training and certification requirements. Note: Authority cited: Sections 100275, 105250 and 124160, Health and Safety Code. Reference: Sections 100275, 105250 and 124160, Health and Safety Code. s 36000. Requirements for Lead Hazard Evaluation for Public and Residential Buildings. (a) Lead hazard evaluation for public and residential buildings shall: (1) Be conducted only by a certified lead inspector/assessor. The certified lead inspector/assessor conducting lead hazard evaluation shall not conduct abatement on the same structure. (2) Be conducted in a manner in which paint, dust, and soil is tested in accordance with the procedures described in Chapter 5: Risk Assessment, section II (A)(B)(C)(D), "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, June 1995 and Chapter 7: Lead-Based Paint Inspection, "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, 1997 Revision, and which provides quantitative results. (3) Be conducted in a manner in which paint, dust, and soil samples taken for laboratory analysis are analyzed by a laboratory that is recognized by the U.S. Environmental Protection Agency pursuant to United States Code, Title 15, Section 2685(b). (4) Be documented in a lead hazard evaluation report which shall include a completed Department of Health Services (DHS) Form 8552 (12/97) and the following attachments: (A) A foundation diagram, site map, or sketch of the structure, indicating the specific locations of each lead hazard or presence of lead-based paint, and results of the visual inspection, if applicable; (B) A summary of each testing method, device, and sampling procedure used; (C) A description of testing and sampling locations; and (D) The results of laboratory analysis on collected samples, if applicable, including the name, address, and telephone number of each laboratory. (b) The certified lead inspector/assessor conducting the lead hazard evaluation for a public or residential building shall retain the original completed copy of DHS Form 8552 (12/97) and attachments for a minimum of three years and distribute copies as follows; (1) A copy of the completed DHS Form 8552 (12/97) and attachments to the person who ordered the lead hazard evaluation; (2) A copy of the completed DHS Form 8552 (12/97) to the Department within thirty days of completion; and (3) A copy of the attachments to the Department upon request. (c) In addition to the requirements specified in subsections (a) and (b): (1) A lead inspection shall be conducted in accordance with procedures described in Chapter 7: Lead-Based Paint Inspection, "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, 1997 Revision. (2) A risk assessment shall be conducted in accordance with procedures described in Chapter 5: Risk Assessment, section II(A), (B), (C), and (D), "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, June 1995 and shall include a written description of abatement options for each identified lead hazard, a suggested prioritization for addressing each lead hazard, and recommendations for a maintenance and monitoring schedule. (3) A clearance inspection shall be conducted: (A) By a certified lead inspector/assessor or a certified lead project monitor. (B) In accordance with procedures such as described in Chapter 15: Clearance, sections II-VI, "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, June 1995. Note: Authority cited: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. Reference: Sections 100170, 105250(a) and (b), 124160(b) and 124165, Health and Safety Code; Sections 17200, 17203 and 17205, Business and Professions Code; and Sections 11180 and 11181, Government Code. s 36100. Requirements for Abatement for Public and Residential Buildings. (a) Abatement for public and residential buildings which is designed to reduce lead paint or lead hazards for a minimum of twenty years shall be conducted: (1) Only by a certified lead supervisor or a certified lead worker. A certified lead supervisor shall be onsite during all work site preparation and during the post-abatement cleanup of work areas. At all other times when abatement is conducted, the certified lead supervisor shall be onsite or available by telephone, pager or answering service, and able to be present at the work area in no more than two hours. (2) According to the procedures specified in Chapter 12: Abatement, "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, June 1995. (3) Using containment and in a manner which does not result in contaimination of non-work areas with lead-contaminated dust, lead-contaminated soil, or lead-based paint debris. (4) In accordance with an abatement plan prepared by a certified lead supervisor, certified lead project monitor, or certified lead project designer which shall: (A) Include the following information: 1. A detailed written description of the measures and management procedures, including containment, that will be utilized during abatement to prevent exposure to lead hazards; 2. A detailed written description of abatement, including methods of abatement and locations of rooms and components where abatement is planned; 3. A recommended schedule for re-inspection, based upon the type of abatement; and 4. Instructions on how to maintain potential lead hazards in safe condition. (B) Be retained and made available to the Department upon request for a period of at least three years by the preparer. (5) After notification is posted and delivered pursuant to subsection (c), the certified lead supervisor conducting abatement shall retain records of notification for at least three years. (6) In a manner in which after abatement is completed, a clearance inspection is conducted in accordance with Section 36000(a) and Section 36000(c)(3) of this Chapter. (b) Abatement for public and residential buildings which is designed to reduce lead paint or lead hazards for less than twenty years shall be conducted: (A) According to procedures specified in Chapter 11: Interim Controls, "Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S. Department of Housing and Urban Development, June 1995. (2) Using containment and in a manner which does not result in contamination of non-work areas with lead-contaminated dust, lead-contaminated soil, or lead-based paint debris. (3) In a manner to ensure that the work area has no lead contaminated dust following the completion of abatement. (4) In a manner to ensure that a clearance inspection is conducted following the completion of abatement, if abatement was conducted in response to an identified case of lead poisoning as defined in Section 105280(b) of the California Health and Safety Code. (5) After notification is posted and delivered pursuant to subsection (c). (c) Prior to conducting abatement, the individual conducting abatement shall provide notification by completing an Abatement of Lead Hazards Notification, DHS 8551 (12/97), form and: (1) Posting at all entrances to the work area a copy of the completed form which shall not be removed until abatement has been completed and, for abatement conducted pursuant to subsection (a), a clearance inspection has been completed; and (2) Delivering a copy of the completed form to the Department. Except for abatement conducted in response to an identified case of lead poisoning as defined in Section 105280(b) of the Health and Safety Code, the completed form shall be delivered to the Department at least five days prior to conducting abatement. (d) Any individual conducting abatement or disturbing lead-based paint without containment shall permit the Department, or enforcement agencies, as specified in the California Health and Safety Code Sections 17960, 17961, and 17965, to access work areas to determine compliance with the requirements of this section. Note: Authority cited: Sections 105250(a) and (b), 124160(b) and 124165, Health and Safety Code. Reference: Sections 17960, 17961, 17964, 17970, 17972, 17980, 100170, 100175, 105250(a) and (b), 105280(a), 124160(b) and 124165, Health and Safety Code; Section 3494, Civil Code; Section 17200, Business and Professions Code; Section 17274(b), Revenue and Taxation Code; and Sections 11180 and 11181, Government Code. Petitioners in the lawsuit Healthy Children Organizing Project, et al. v. Department of Health Services, et al., Superior Court of California in and for the City and County of San Francisco, Case No. 313012, challenged the validity of the emergency regulations, "Screening for Childhood Lead Poisoning". The court found that the regulations did not comply with the statutory requirements. In response to the court order and comments received during the open comment period, the Department revised the regulations. The revised regulations were submitted to the court and made available for public comment. The following regulations reflect changes made in response to public comments already received and further changes that will be made available for an additional public comment period. The Department sought adoption of these emergency regulations for the purpose of avoiding the lapse of the medical standard of care and avoiding confusion among impacted health care providers during the period between the normal expiration of the prior emergency regulations and the completion of the regulatory process. s 37000. Health Care Provider. "Health care provider" means a person licensed to practice medicine pursuant to Article 3 (commencing with Section 2050) of Chapter 5 of Division 2 of the Business and Professions Code; a person licensed to practice as a nurse practitioner pursuant to Article 8 (commencing with Section 2834) of Chapter 6 of Division 2 of the Business and Professions Code; or a person licensed to practice as a physician's assistant pursuant to Article 3 (commencing with Section 3513) of Chapter 7.7 of Division 2 of the Business and Professions Code. Note: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code. s 37005. Physician. Note: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code. s 37010. Physician's Assistant. Note: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code. s 37015. Primary Medical Care. Note: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code. s 37020. Publicly Funded Program for Low Income Children. "Publicly funded program for low income children" means: (a) Medi-Cal, as defined in Chapter 7 (commencing with Section 14000) and Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code; (b) Child Health and Disability Prevention program, as defined in Article 6 (commencing with Section 124025) of Chapter 3 of Part 2 of Division 106 of the Health and Safety Code; (c) Healthy Families, as defined in Part 6.2 (commencing with Section 12693) of Division 2 of the Insurance Code; (d) Special Supplemental Nutrition Program for Women, Infants and Children, as defined in Article 2 (commencing with Section 123275) of Chapter 1 of Part 2 of Division 106 of the Health and Safety Code; or (e) Any federally funded or State of California funded program that provides medical services or preventive healthcare to children in families whose income is equal to or less than the maximum qualifying income level for participation in any of the programs specified in subsections (a) through (d). Note: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code. s 37025. Screening. "Screening" means testing an asymptomatic child for lead poisoning by analyzing the child's blood for concentration of lead. Note: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code. s 37100. Requirements. (a) Except as provided in subsections (c) and (d), every health care provider who performs a periodic health assessment of a child, at the ages specified in subsection (b), shall comply with the following standard of care: (1) Provide oral or written anticipatory guidance to a parent or guardian of the child, including, at a minimum, the information that children can be harmed by exposure to lead, especially deteriorating or disturbed lead-based paint and the dust from it, and are particularly at risk of lead poisoning from the time the child begins to crawl until 72 months of age. (2) If the child receives services from a publicly funded program for low-income children, order the child screened for lead poisoning as the child is presumed to be at risk of lead poisoning. (3) If the child does not receive services from a publicly funded program for low-income children, evaluate the child's risk of lead poisoning by asking a parent or guardian of the child the following question: "Does your child live in, or spend a lot of time in, a place built before 1978 that has peeling or chipped paint or that has been recently renovated?" If the parent or guardian answers "yes" or "don't know" to the question, order the child screened for lead poisoning. (b) Except as provided in subsections (c) and (d), the health care provider shall perform the actions specified in subsection (a) at each of the following times: (1) The anticipatory guidance required by subsection (a)(1) shall be performed at each periodic health assessment, starting at 6 months of age and continuing until 72 months of age. (2) The screening and evaluation required by subsections (a)(2) or (3) shall be performed: (A) When the child is 12 months of age. (B) When the child is 24 months of age. (C) Whenever the health care provider performing a periodic health assessment becomes aware that the child is 12 months to 24 months of age and the actions specified in subsections (a)(2) or (3) were not taken at 12 months of age or thereafter. (D) Whenever the health care provider performing a periodic health assessment becomes aware that the child is 24 months to 72 months of age and the actions specified in subsections (a)(2) or (3) were not taken when the child was 24 months of age or thereafter. (E) Whenever the health care provider performing a periodic health assessment of a child 12 to 72 months of age becomes aware that, in the professional judgment of the health care provider, a change in circumstances has put the child at risk of lead poisoning. (c) The health care provider shall have no duty to order a child screened for lead poisoning if a parent or guardian of the child, or other person with legal authority to withhold consent, refuses to consent to the screening. (d) The health care provider shall have no duty to order a child screened for lead poisoning, if and so long as the risk of screening is a greater risk to the child's health than the risk of lead poisoning, in the professional judgment of the health care provider. The health care provider shall document the reasons for not screening in the child's medical record. (e) Upon receiving the results of a blood lead analysis in which the blood lead level is equal to or greater than 10 micrograms of lead per deciliter of blood, the health care provider shall take those actions that are reasonable and medically necessary to reduce, to the extent possible, the child's blood lead level below 10 micrograms of lead per deciliter of blood, such as the following: (1) Education of a parent or guardian on lead hazards and lead poisoning; (2) Clinical evaluation for complications of lead poisoning; (3) Follow-up blood lead analyses: (A) At one- to two-month intervals until the blood lead level has remained less than 15 micrograms of lead per deciliter of blood for at least six calendar months and the source of the lead poisoning has been removed or remediated; and (B) Thereafter, unless the child has received additional lead-hazard exposure, at three-month intervals until the child is 36 months of age; (4) Referring the family to the local childhood lead poisoning prevention program or, if none, the local health jurisdiction; and (5) Chelation therapy, if appropriate in the professional judgment of the health care provider. (f) A health care provider who fails to comply with this standard of care may be subject to the disciplinary provisions of Article 12 (commencing with Section 2220) of Chapter 5 of Division 2 the Business and Professions Code. Note: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safety Code. Reference: Section 105285, Health and Safety Code. s 38001. Occupational Lead Poisoning Prevention Program: Definitions. (a) "Altered or disturbed" means subjected to a process that may result in the release of dust, mist, fume, or other particles; such processes may include, but are not limited to, cutting, welding, grinding, polishing, machining, scraping, melting, sanding, spraying or pressure blasting. (b) "De minimus amount" means any of the following: (1) Lead present in materials which are altered or disturbed and have a lead concentration less than 0.5% (5000 ppm) by weight; (2) Lead present in materials where the total weight of such materials altered or disturbed during the calendar year is known to be 16 ounces (one pound) or less by weight; (3) Lead present in materials where no such material is altered or disturbed at any individual employee's place of employment on more than one day during the calendar year, i.e., if no employee works on more than one day during the calendar year in any location where lead-containing materials are being altered or disturbed, then the amount is de minimus. (c) "Employee" means any individual employed for at least 160 hours in the prior calendar year, regardless of whether the individual's specific job involved potential exposure to lead or lead-containing materials. (d) "Lead evaluation" means a review of the place of employment and the materials and processes involved in the operation of an employer's business, including but not limited to review of Material Safety Data Sheets or other manufacturer-supplied data, product labeling, or analytical testing results for presence of lead in materials of unknown composition. (e) "Lead was not present at the place of employment" means that no amount of lead or lead-containing material was present at the place of employment or in the materials and processes used in the operation of the employer's business, with the following exceptions: (1) Lead that was not altered or disturbed during the operation of the employer's business and was present in a form, or contained in such a manner, that it could not be inhaled or ingested (examples are undisturbed building materials, unused materials and supplies, intact lead storage batteries); or (2) Lead present as a result of general environmental contamination which was not the result of the operation of the employer's business. (f) "Metal work" means the machining or casting of metals or metal alloys. (g) "Occupational Lead Poisoning Fee" means a fee pursuant to section 105190 of the Health and Safety Code which is assessed annually by the State Board of Equalization on employers with 10 or more employees in industries identified by the Department of Health Services as having documented evidence of potential occupational lead poisoning. These industries are listed by four-digit Standard Industrial Classification (SIC) Code in Section 38005. (h) "Place of employment" means any location, not limited to a fixed site, where employees carry out work duties which are a part of a business operation. (i) "Prior calendar year" means the time period from January 1 to December 31 of the year preceding that year in which the Occupational Lead Poisoning Fee is due. (j) "Standard Industrial Classification (SIC) Code" means a system of four-digit numerical codes to designate the activities of a business operation, set forth by the U.S. Office of Management and Budget in the Standard Industrial Classification Manual, 1987. Note: Authority cited: Sections 105185 and 105191, Health and Safety Code. Reference: Sections 105185, 105190, 105191 and 105195, Health and Safety Code. s 38002. Fee Waiver Eligibility. (a) An employer in an industry listed in section 38005 is eligible for a waiver of the Occupational Lead Poisoning Fee if the employer can demonstrate, by completing the procedures specified in section 38003, that: (1) Lead was not present at the place of employment during the prior calendar year; or (2) Lead was present at the place of employment during the prior calendar year only in a de minimus amount. (b) An employer in an industry listed in section 38005 is not required to pay the Occupational Lead Poisoning Fee if the employer had fewer than 10 employees during the previous year. (c) An employer in an industry listed in section 38005 that involves painting, including but not limited to Standard Industrial Classification Code 1721, "Painting and Paper Hanging," is not eligible for a fee waiver if, in the operation of the employer's business in the prior calendar year, any employees altered or disturbed paint in or on a building constructed prior to 1978 or on a painted metal structure, unless the employer demonstrates that lead was not present in any of the altered or disturbed paint, or was present only in a de minimus amount. (d) An employer in an industry listed in section 38005 that involves demolition, including but not limited to Standard Industrial Classification Code 1795, "Wrecking and Demolition Work," is not eligible for a fee waiver if, in the operation of the employer's business in the prior calendar year, any employees altered or disturbed a painted metal structure, or a building with painted surfaces that was constructed prior to 1978, unless the employer demonstrates that lead was not present in any of the disturbed paint, or was present only in a de minimus amount. (e) An employer in an industry listed in section 38005 that involves handling or processing of scrap metal, including but not limited to Standard Industrial Classification Code 5093, "Scrap and Waste Materials," is not eligible for a fee waiver if, in the operation of the employer's business in the prior calendar year, any employees altered or disturbed materials that may contain lead or have a lead-containing coating, unless the employer demonstrates that lead was not present in any of the altered or disturbed materials, or was present only in a de minimus amount. (f) An employer's request for a fee waiver may be denied for any of the following reasons: (1) Identification of the presence of lead in a greater than de minimus amount at the place of employment or in the materials or processes used in the operation of the employer's business; or (2) Failure of an employer to request a fee waiver and supply the documentation required in section 38003(d) within 180 days following the due date of the Occupational Lead Poisoning Fee; or (3) Failure of an employer to provide sufficient and accurate information by which to evaluate the request for a fee waiver. (g) The Department shall give written notice to the employer of the denial of an employer's request for a fee waiver and the reason or reasons for the denial. (h) An employer whose request for a fee waiver is denied shall have 15 working days from receipt of notice of the denial to request a reconsideration of the denial and to supply any additional facts which the employer believes support the granting of the fee waiver request. Note: Authority cited: Sections 105185 and 105191, Health and Safety Code. Reference: Sections 105190(e) and 105191(b), Health and Safety Code. s 38003. Procedures for Application of a Waiver. (a) An employer requesting a fee waiver shall conduct a lead evaluation of the premises, materials and processes used in the operation of the employer's business during the prior calendar year to determine whether lead was present. This evaluation shall include, but not be limited to, review of Material Safety Data Sheets or other manufacturer-supplied data, product labeling, or analytical testing results for presence of lead in materials of unknown composition. (b) An employer requesting a fee waiver shall establish that lead was not present, or was present only in a de minimus amount, at the place of employment during the prior calendar year. (c) An employer requesting a fee waiver shall have 180 days following the due date of the Occupational Lead Poisoning Fee to submit documentation that lead was not present, or was present only in a de minimus amount, at the place of employment during the prior calendar year. (d) An employer requesting a fee waiver shall demonstrate that lead was not present, or was present in a de minimus amount, at the place of employment by providing documentation that includes: (1) A Request for a Waiver of the Occupational Lead Poisoning Fee [DHS Form 8484 (4/97)], which is hereby incorporated by reference, containing the following information: (A) Name, title, and affiliation of the person who conducted the lead evaluation of the employer's business operation as outlined in section 38003(a) and, if a consultant, also telephone number and address. (B) Statement signed by the person conducting the lead evaluation that attests that, to the best of the person's knowledge, no lead or lead-containing materials were present in any amount, or were present only in a de minimus amount (as defined in section 38001) during the prior calendar year, in the premises, materials and processes used in the operation of the business. (C) Description of the nature of the employer's business, including a description of the products manufactured and/or services provided. (D) The employer's Board of Equalization-designated, 8-digit account number provided to the employer at the time the Occupational Lead Poisoning Fee is assessed. (E) Name, title, company, address, telephone number, and signature of an authorized representative of the employer who is requesting the fee waiver. (F) An employer in an industry listed in section 38005 that involves construction work, who wishes to apply for a fee waiver, shall identify the extent to which the company's operations involved altering or disturbing painted surfaces by completing Part B of Form DHS 8484 (4/97). (G) An employer in an industry listed in section 38005 that involves detective, guard, armored car or other security services, who wishes to apply for a waiver, shall identify the extent to which the company's operations involved altering or disturbing lead materials by discharging weapons on company time by completing Part C of Form DHS 8484 (4/97). (H) An employer in an industry listed in section 38005 that involves metal work who wishes to apply for a fee waiver, shall identify the extent to which the company's operations involved altering or disturbing lead-containing metals or alloys (including lead-containing brass or bronze) by completing Part D of Form DHS 8484 (4/97). (I) An employer in an industry listed in section 38005 that involves the handling or processing of scrap metal who wishes to apply for a fee waiver, shall identify the extent to which the company's operations involved altering or disturbing lead-containing or lead-painted scrap metal by completing Part E of Form DHS 8484 (4/97). (2) Correspondence from an employer, workers' compensation representative, or consultant that includes all of the information outlined in section 38003(d)(1). (e) An employer requesting a fee waiver may be required to provide additional information describing the nature of the employer's business, including the premises, materials or processes used in the operation of the employer's business. (f) Results of industrial hygiene monitoring tests that show non-detectable concentrations of lead in workplace air shall not be considered sufficient documentation that lead was not present at the place of employment. Note: Authority cited: Sections 105185 and 105191, Health and Safety Code. Reference: Sections 105190(e) and 105191(b), Health and Safety Code. s 38004. Periods for Which Fee Waivers Are Granted. (a) The Department shall have the discretion to grant a permanent or annual waiver of the Occupational Lead Poisoning Fee to an employer who has provided acceptable documentation that lead was not present at the place of employment, or was present only in a de minimus amount. The decision to grant a permanent waiver or annual waiver shall be based on: (1) A description of the employer's business operation; (2) The potential for lead use within the industries classified under the employer's Standard Industrial Classification Code; (3) The likelihood that the employer's business operation may change over time, causing lead to become present at the place of employment in a greater than de minimus amount. (b) The Department shall, at the timer a fee waiver is granted, inform the employer of whether the waiver is granted on a permanent or annual basis. (c) The Department shall rescind a company's permanent waiver of the Occupational Lead Poisoning Fee if the Department obtains evidence, including but not limited to a substantiated case report of occupational lead poisoning in an employee, that indicates that lead is present in a greater than de minimus amount at the place of employment. (d) The Department shall rescind a company's annual waiver of the Occupational Lead Poisoning Fee if the Department obtains evidence, including but not limited to a substantiated case report of occupational lead poisoning in an employee, that indicates that lead was present in a greater than de minimus amount at the place of employment during the calendar year for which the annual waiver was granted. (e) An employer who is granted a permanent fee waiver shall notify the Department within 30 days of any changes in the premises, materials or processes used in the operation of the business that result in lead being present in a greater than de minimus amount at the place of employment. (f) An employer who is granted an annual waiver shall notify the Department within 30 days if the employer becomes aware that lead was present in a greater than de minimus amount at the place of employment during the calendar year for which the annual waiver was granted. Note: Authority cited: Sections 105185 and 105191, Health and Safety Code. Reference: Sections 105190(e) and 105191(b), Health and Safety Code. s 38005. Occupational Lead Poisoning Fee: Applicable Industries. (a) The list of industries in section 105195 of the California Health and Safety Code for which the Occupational Lead Poisoning Fee is applicable is hereby modified as follows: SIC Code Industry (1) 1041 Gold ores (2) 1521 General contractors - Single-family houses (3) 1541 General contractors - Industrial buildings and warehouses (4) 1542 General contractors - Nonresidential buildings, other than industrial buildings and warehouses (5) 1611 Highway and street construction, except elevated highways (6) 1622 Bridge, tunnel, and elevated highway construction (7) 1623 Water, sewer, pipeline and communications and power line construction (8) 1629 Heavy construction, not elsewhere classified (9) 1711 Plumbing, heating, and air-conditioning (10) 1721 Painting and paper hanging (11) 1761 Roofing, siding and sheet metal work (12) 1791 Structural steel erection (13) 1795 Wrecking and demolition work (14) 1796 Installation or erection of building equipment, not elsewhere classified (15) 1799 Special trade contractors, not elsewhere classified (16) 2759 Commercial printing, not elsewhere classified (17) 2782 Blankbooks, looseleaf binders and devices (18) 2816 Inorganic pigments (19) 2819 Industrial inorganic chemicals, not elsewhere classified (20) 2821 Plastics material, synthetic resins, and nonvulcanizable elastomers (21) 2851 Paints, varnishes, lacquers, enamels, and allied products (22) 2869 Industrial organic chemicals, not elsewhere classified (23) 2891 Adhesives and sealants (24) 2892 Explosives (25) 2899 Chemicals and chemical preparations, not elsewhere classified (26) 3053 Gaskets, packing, and sealing devices (27) 3069 Fabricated rubber products, not elsewhere classified (28) 3087 Custom compounding of purchased plastics resins (29) 3089 Plastics products, not elsewhere classified (30) 3229 Pressed and blown glass and glassware, not elsewhere classified (31) 3231 Glass products, made of purchased glass (32) 3253 Ceramic floor and wall tile (33) 3261 Vitreous china plumbing fixtures and china and earthenware fittings and bathroom accessories (34) 3262 Vitreous china table and kitchen articles (35) 3269 Pottery products, not elsewhere classified (36) 3312 Steel works, blast furnaces (including coke ovens), and rolling mills (37) 3313 Electrometallurgical products, except steel (38) 3315 Steel wiredrawing and steel nails and spikes (39) 3316 Cold-rolled steel sheet, strip and bars (40) 3317 Steel pipe and tubes (41) 3321 Gray and ductile iron foundries (42) 3325 Steel foundries, not elsewhere classified (43) 3331 Primary smelting and refining of copper (44) 3339 Primary smelting and refining of nonferrous metals, except copper and aluminum (45) 3341 Secondary smelting and refining of nonferrous metals (46) 3351 Rolling, drawing, and extruding of copper (47) 3356 Rolling, drawing, and extruding of nonferrous metals, except copper and aluminum (48) 3357 Drawing and insulating of nonferrous wire (49) 3363 Aluminum die-castings (50) 3364 Nonferrous die-castings, except aluminum (51) 3365 Aluminum foundries (52) 3366 Copper foundries (53) 3369 Nonferrous foundries, except aluminum and copper (54) 3398 Metal heat treating (55) 3399 Primary metal products, not elsewhere classified (56) 3411 Metal cans (57) 3429 Hardware, not elsewhere classified (58) 3431 Enameled iron and metal sanitary ware (59) 3432 Plumbing fixture fittings and trim (60) 3433 Heating equipment, except electric and warm air furnaces (61) 3441 Fabricated structural metal (62) 3444 Sheet metal work (63) 3463 Nonferrous forgings (64) 3479 Coating, engraving, and allied services, not elsewhere classified (65) 3484 Small arms (66) 3491 Industrial valves (67) 3492 Fluid power valves and hose fittings (68) 3494 Valves and pipe fittings, not elsewhere classified (69) 3496 Miscellaneous fabricated wire products (70) 3497 Metal foil and leaf (71) 3532 Mining machinery and equipment, except oil and gas field machinery and equipment (72) 3544 Special dies and tools, die sets, jigs and fixtures, and industrial molds (73) 3561 Pumps and pumping equipment (74) 3567 Industrial process furnaces and ovens (75) 3585 Air-conditioning and warm air heating equipment and commercial and industrial refrigeration equipment (76) 3599 Industrial and commercial machinery and equipment, not elsewhere classified (77) 3624 Carbon and graphite products (78) 3661 Telephone and telegraph apparatus (79) 3663 Radio and television broadcasting and communications equipment (80) 3669 Communications equipment, not elsewhere classified (81) 3671 Electron tubes (82) 3674 Semiconductors and related devices (83) 3678 Electronic connectors (84) 3679 Electronic components, not elsewhere classified (85) 3691 Storage batteries (86) 3692 Primary batteries, dry and wet (87) 3699 Electrical machinery, equipment and supplies, not elsewhere classified (88) 3711 Motor vehicles and passenger car bodies (89) 3714 Motor vehicle parts and accessories (90) 3721 Aircraft (91) 3728 Aircraft parts and auxiliary equipment, not elsewhere classified (92) 3812 Search, detection, navigation, guidance, aeronautical, and nautical systems and instruments (93) 3825 Instruments for measuring and testing of electricity and electrical signals (94) 3829 Measuring and controlling devices, not elsewhere classified (95) 3844 X-ray apparatus and tubes and related irradiation apparatus (96) 3914 Silverware, plated ware, and stainless steel ware (97) 3949 Sporting and athletic goods, not elsewhere classified (98) 3953 Marking devices (99) 3965 Fasteners, buttons, needles, and pins (100) 4813 Telephone communications, except radiotelephone (101) 4911 Electric services (102) 5064 Electrical appliances, television and radio sets (103) 5093 Scrap and waste materials (104) 5941 Sporting goods stores and bicycle shops (105) 7381 Detective, guard, and armored car services (106) 7538 General automotive repair shops (107) 7539 Automotive repair shops, not elsewhere classified (108) 7997 Membership sports and recreation clubs (109) 7999 Amusement and recreation services, not elsewhere classified (110) 8734 Testing laboratories Note: Authority cited: Sections 105185 and 105195, Health and Safety Code. Reference: Section 105195, Health and Safety Code.