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(continued)
(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 eachdevice only; (continued)