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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. (continued)