text:
(a) For purposes of this article, the following terms have the following definitions:

(1) “Food packaging” means a nondurable package, packaging component, or food service ware that is intended to contain, serve, store, handle, protect, or market food, foodstuffs, or beverages, and is comprised, in substantial part, of paper, paperboard, or other materials originally derived from plant fibers. “Food packaging” includes food or beverage containers, take-out food containers, unit product boxes, liners, wrappers, serving vessels, eating utensils, straws, food boxes, and disposable plates, bowls, or trays.

(2) “Perfluoroalkyl and polyfluoroalkyl substances” or “PFAS” means a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.

(3) “Regulated perfluoroalkyl and polyfluoroalkyl substances or PFAS” means either of the following:

(A) PFAS that a manufacturer has intentionally added to a product and that have a functional or technical effect in the product, including the PFAS components of intentionally added chemicals and PFAS that are intentional breakdown products of an added chemical that also have a functional or technical effect in the product.

(B) The presence of PFAS in a product or product component at or above 100 parts per million, as measured in total organic fluorine.

(b) Commencing on January 1, 2023, no person shall distribute, sell, or offer for sale in the state any food packaging that contains regulated perfluoroalkyl and polyfluoroalkyl substances or PFAS.

(c) A manufacturer shall use the least toxic alternative when replacing regulated perfluoroalkyl and polyfluoroalkyl substances or PFAS in food packaging to comply with this article.

history: (History: Added by Stats. 2021, Ch. 503, Sec. 1. (AB 1200) Effective January 1, 2022.)

path: 104. ENVIRONMENTAL HEALTH > 3. PRODUCT SAFETY > 15. Chemicals of Concern in Food Packaging and Cookware > 1. Plant-Based Food Packaging Containing PFAS


kind: section

code: HSC

text:
For purposes of this article, the following terms have the following definitions:

(a) “Cookware” means durable houseware items that are used in homes and restaurants to prepare, dispense, or store food, foodstuffs, or beverages. “Cookware” includes pots, pans, skillets, grills, baking sheets, baking molds, trays, bowls, and cooking utensils.

(b) “Designated list” means the list of chemicals identified as candidate chemicals that exhibit a hazard trait or an environmental or toxicological endpoint that meets the criteria specified in regulations adopted by the Department of Toxic Substances Control pursuant to Article 14 (commencing with Section 25251) of Chapter 6.5 of Division 20, and is published on the Department of Toxic Substances Control’s internet website pursuant to those regulations.

(c) “Intentionally added chemical” means a chemical that a manufacturer has intentionally added to a product and that has a functional or technical effect in the product, including the components of intentionally added chemicals and intentional breakdown products of an added chemical that also have a functional or technical effect in the product.

(d) “Manufacturer” means either of the following:

(1) A person or entity who manufactures the cookware and whose name appears on the product label.

(2) A person or entity who the cookware is manufactured for or distributed by, identified by the product label pursuant to the federal Fair Packaging and Labeling Act (15 U.S.C. Sec. 1451 et seq.).

(e) “Product label” means a display of written, printed, or graphic material that appears on, or is affixed to, the exterior of a product, or its exterior container or wrapper that is visible to a consumer, if the product has an exterior container or wrapper.

division: 104. ENVIRONMENTAL HEALTH

part: 3. PRODUCT SAFETY

article: 2. Chemical Disclosures for Cookware

path: 104. ENVIRONMENTAL HEALTH > 3. PRODUCT SAFETY > 15. Chemicals of Concern in Food Packaging and Cookware > 2. Chemical Disclosures for Cookware


text:
(a) Commencing on January 1, 2024, a manufacturer of cookware sold in the state that contains one or more intentionally added chemicals present on the designated list in the handle of the product or in any product surface that comes into contact with food, foodstuffs, or beverages shall list the presence of those chemicals on the product label. The list of intentionally added chemicals shall be introduced by the phrase “This product contains:”, and shall include on the product label a statement, in both English and Spanish, that reads: “For more information about chemicals in this product, visit”, followed by both of the following:

(1) An internet website address for a web page that provides all of the information required by Section 109012.

(2) A quick response (QR) code or other machine-readable code, consisting of an array of squares, used for storing an internet website for a web page that provides all of the information required by Section 109012.

(b) A manufacturer of cookware sold in the state shall ensure that the statement required on the product label by subdivision (a) is visible and legible to the consumer, including on the product listing for online sales.

(c) (1) Except as provided in paragraph (2), cookware that meets both of the following requirements is exempt from the requirements of this section:

(A) The surface area of the cookware cannot fit a product label of at least two square inches.

(B) The cookware does not have either of the following:

(i) An exterior container or wrapper on which a product label can appear or be affixed.

(ii) A tag or other attachment with information about the product attached to the cookware.

(2) A manufacturer of cookware sold in the state shall ensure that the statement otherwise required on a product label by subdivision (a) is included on the product listing for online sales pursuant to subdivision (b).

chapter: 15. Chemicals of Concern in Food Packaging and Cookware

article: 2. Chemical Disclosures for Cookware


text:
Commencing on January 1, 2023, a manufacturer of cookware sold in the state that contains one or more intentionally added chemicals present on the designated list in the handle of the product or in any cookware surface that comes into contact with food, foodstuffs, or beverages shall post on the internet website for the cookware all of the following:

(a) A list of all chemicals in the cookware that are also present on the designated list.

(b) The names of the authoritative list or lists referenced by the Department of Toxic Substances Control in compiling the designated list on which each chemical in the cookware is present.

(c) A link to the internet website for the authoritative list or lists identified pursuant to subdivision (b).

article: 2. Chemical Disclosures for Cookware


text: Commencing on January 1, 2023, on the internet website for the cookware, and on January 1, 2024, on the cookware package, a manufacturer shall not make a claim that the cookware is free of any specific chemical if the chemical belongs to a chemical group or class identified on the designated list, unless no individual chemical from that chemical group or class is intentionally added to the cookware.

article: 2. Chemical Disclosures for Cookware


text: Cookware that contains one or more intentionally added chemicals present on the designated list in the handle of the product or in any product surface that comes into contact with food, foodstuffs, or beverages shall not be sold, offered for sale, or distributed in the state unless the cookware and the manufacturer of the cookware comply with this article.

article: 2. Chemical Disclosures for Cookware


text:
For purposes of this chapter, the following definitions apply:

(a) “Compact fluorescent lamp” means a compact low-pressure, mercury-containing, electric-discharge light source in which a fluorescent coating transforms some of the ultraviolet energy generated by the mercury discharge into visible light, and includes all of the following characteristics:

(1) One base (end cap) of any type, including, but not limited to, screw, bayonet, two pins, and four pins.

(2) Integrally ballasted or non-integrally ballasted.

(3) Light emission between a correlated color temperature of 1700K and 24000K and a Duv of +0.024 and -0.024 in the International Commission on Illumination (CIE) Uniform Color Space (CAM02-UCS).

(4) All tube diameters and all tube lengths.

(5) All lamp sizes and shapes for directional and nondirectional installations, including, but not limited to, PL, spiral, twin tube, triple twin, 2D, U-bend, and circular.

(b) “Linear fluorescent lamp” means a low-pressure, mercury-containing, electric-discharge light source in which a fluorescent coating transforms some of the ultraviolet energy generated by the mercury discharge into visible light, and includes all of the following characteristics:

(1) Two bases (end caps) of any type, including, but not limited to, single-pin, two-pin, and recessed double contact.

(2) Light emission between a correlated color temperature of 1700K and 24000K and a Duv of +0.024 and -0.024 in the CIE CAM02-UCS.

(3) All tube diameters, including, but not limited to, T5, T8, T10, and T12.

(4) All tube lengths from 0.5 to 8.0 feet, inclusive.

(5) All lamp shapes, including, but not limited to, linear, U-bend, and circular.

history: (History: Added by Stats. 2022, Ch. 409, Sec. 1. (AB 2208) Effective January 1, 2023.)

chapter: 16. Mercury-Containing Lighting

path: 104. ENVIRONMENTAL HEALTH > 3. PRODUCT SAFETY > 16. Mercury-Containing Lighting


text:
(a) On and after January 1, 2024, a screw or bayonet base type compact fluorescent lamp shall not be offered for final sale, sold at final sale, or distributed in this state as a new manufactured product.

(b) On and after January 1, 2025, a pin-base type compact fluorescent lamp or a linear fluorescent lamp shall not be offered for final sale, sold at final sale, or distributed in this state as a new manufactured product.


text:
This chapter does not apply to the following:

(a) A lamp used for image capture and projection, including photocopying, printing, directly or in preprocessing, lithography, film and video projection, and holography.

(b) A lamp that has a high proportion of ultraviolet light emission and is one of the following:

(1) A lamp with high ultraviolet content that has ultraviolet power greater than two milliwatts per kilolumen (mW/klm).

(2) A lamp for germicidal use, such as the destruction of DNA, that emits a peak radiation of approximately 253.7 nanometers.

(3) A lamp used for disinfection or fly trapping from which either the radiation power emitted between 250 and 315 nanometers represents at least 5 percent of, or the radiation power emitted between 315 and 400 nanometers represents at least 20 percent of, the total radiation power emitted between 250 and 800 nanometers.

(4) A lamp used for the generation of ozone where the primary purpose is to emit radiation at approximately 185.1 nanometers.

(5) A lamp used for coral zooxanthellae symbiosis from which the radiation power emitted between 400 and 480 nanometers represents at least 40 percent of the total radiation power emitted between 250 and 800 nanometers.

(6) Any lamp used in a sunlamp product, defined as any electronic product designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning (21 CFR 1040.20(b)(9)).

(c) A lamp used for medical or veterinary diagnosis or treatment, or used in a medical device.

(d) A lamp used in pharmaceutical product manufacturing or quality control.

(e) A lamp used for spectroscopy and photometric applications, such as, for example, UV-visible spectroscopy, molecular spectroscopy, atomic absorption spectroscopy, nondispersive infrared (NDIR), Fourier transform infrared (FTIR), medical analysis, ellipsometry, layer thickness measurement, process monitoring, or environmental monitoring.

(f) A lamp used by academic and research institutions exclusively for conducting research projects and experiments.


text:
(a) Commencing January 1, 2027, a person or entity shall not manufacture, sell, deliver, distribute, hold, or offer for sale, in commerce a food product for human consumption that contains any of the following substances:

(1) Brominated vegetable oil (CAS no. 8016-94-2).

(2) Potassium bromate (CAS no. 7758-01-2).

(3) Propylparaben (CAS no. 94-13-3).

(4) Red dye 3 (CAS no. 16423-68-0).

(b) (1) Upon an action brought by the Attorney General, a city attorney, a county counsel, or a district attorney, a person or entity that violates subdivision (a) shall be liable for a civil penalty not to exceed five thousand dollars ($5,000) for a first violation, and not to exceed ten thousand dollars ($10,000) for each subsequent violation.

(2) This section does not impair or impede any other rights, causes of action, claims, or defenses available under any other law. The remedies provided in this section are cumulative with any other remedies available under any other law.

history: (History: Added by Stats. 2023, Ch. 328, Sec. 2. (AB 418) Effective January 1, 2024.)

chapter: 17. Food Safety

path: 104. ENVIRONMENTAL HEALTH > 3. PRODUCT SAFETY > 17. Food Safety


text:
The Legislature finds and declares all of the following:

(a) Di(2-ethylhexyl) phthalate (DEHP) and other ortho-phthalates are toxic chemicals and can have negative impacts on human health as determined by the United States Food and Drug Administration, the United States Environmental Protection Agency, or the Office of Environmental Health Hazard Assessment within the California Environmental Protection Agency.

(b) They are used primarily to produce flexibility in plastics, mainly polyvinyl chloride (PVC).

(c) This includes DEHP, the most common ‘plasticizer’ used in medical devices, including intravenous solution containers (IV bags) and IV tubing.

(d) Over the course of its shelf life, DEHP leaches out of the plastic into the solution being held in the container.

(e) DEHP is classified as an endocrine-disrupting compound, meaning it can interfere with the hormonal system in humans and animals. It can mimic or block the actions of hormones, leading to adverse effects on reproductive health, development, and metabolism.

(f) Studies have suggested a potential link between DEHP exposure and certain types of cancer, including breast, liver, lung, and testicular cancer. The United States Environmental Protection Agency (EPA) has determined that DEHP is a probable human carcinogen, and it is included on the Proposition 65 list of chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm.

(g) DEHP exposure has been associated with adverse effects on reproductive organs and fertility. It can disrupt normal reproductive development, reduce sperm quality, and affect hormone levels in both males and females.

(h) DEHP is metabolized in the liver and can accumulate in the body over time. Prolonged exposure to high levels of DEHP has been shown to cause liver and kidney damage in animal studies.

(i) Inhalation or ingestion of DEHP can cause respiratory irritation and allergic reactions in some individuals, particularly those with preexisting respiratory conditions or sensitivities.

(j) While some major hospital systems use IV bags made with alternatives to DEHP, approximately 70 percent of California hospitals are buying and using IV bags made with DEHP.

(k) DEHP dosed at varying concentrations in cell culture studies has been linked to potential multidrug resistance in breast cancer cells that may inhibit the effectiveness of breast cancer drugs.

(l) Triple-negative breast cancer cells dosed in culture with DEHP have been potentially linked to multidrug resistance, inhibiting the apoptosis mechanism induced by breast cancer drugs such as tamoxifen and increasing cell proliferation in vitro. One proposed mechanism is that DEHP may serve as a mitogenic factor for estrogen receptor-positive breast cancer cells, potentially making them multidrug resistant.

history: (History: Added by Stats. 2024, Ch. 562, Sec. 1. (AB 2300) Effective January 1, 2025.)

chapter: 18. Chemicals in Medical Devices

path: 104. ENVIRONMENTAL HEALTH > 3. PRODUCT SAFETY > 18. Chemicals in Medical Devices


text:
For purposes of this chapter, the following terms have the following definitions:

(a) “DEHP” means Di(2-ethylhexyl) phthalate.

(b) “Intentionally added DEHP” means DEHP that a manufacturer has intentionally added to an intravenous solution container or intravenous tubing product that has a functional or technical effect on the product.

(c) “Intravenous solution containers” means a container used to house medicine, fluid, or nutrition therapy that is intravenously administered to patients in a hospital, outpatient, or other health care facility.

(d) “Intravenous tubing” means any tubing used to intravenously administer fluids, medication, or nutrients directly to an adult, child, or infant.

(e) “Ortho-phthalates” means a class of chemicals that are esters of ortho-phthalic acid, including all of the following:

(1) Benzyl-butyl phthalate (BBP) 85-68-7.

(2) Dibutyl phthalate (DBP) 84-74-2.

(3) Dicyclohexyl phthalate (DCHP) 84-61-7.

(4) Di-(2-ethylhexyl) phthalate (DEHP) 117-81-7.

(5) Diethyl phthalate (DEP) 84-66-2.

(6) Di-isobutyl phthalate (DIBP) 84-69-5.

(7) Di-isodecyl phthalate (DIDP) 26761-40-0.

(8) Di-isononyl phthalate (DINP) 28553-12-0.

(9) Di-n-hexyl phthalate (DnHP) 84-75-3.

(10) Di-n-octyl phthalate (DNOP) 117-84-0.

(11) Di-n-pentyl (DnPP) phthalate 131-18-0.

(12) Diisoheptyl phthalate (DIHP) 71888-89-6.

(f) “Unintentionally added DEHP” means DEHP in an intravenous solution container or intravenous tubing product that is not used for functional or technical effect on the product.


text:
(a) Commencing January 1, 2030, a person or entity shall not manufacture, sell, or distribute into commerce in the State of California intravenous solution containers made with intentionally added DEHP.

(b) Commencing January 1, 2035, a person or entity shall not manufacture, sell, or distribute into commerce in the State of California intravenous tubing made with intentionally added DEHP.

(c) A person or entity shall not replace DEHP, pursuant to this chapter, for revised or new products with other ortho-phthalates.

(d) An intravenous solution container or intravenous tubing product shall not have unintentionally added DEHP present at a quantity at or above 0.1 percent weight per weight (w/w).

(e) The following items, as described in Title 21 of the Code of Federal Regulations, are exempt from these provisions:

(1) Human blood collection and storage bags.

(2) Apheresis and cell therapy blood kits and bags, including integral tubing.

(f) A person or entity, due to pending United States Food and Drug Administration approval for the DEHP-free intravenous solution container or due to the manufacturer not having adequate equipment to manufacture the DEHP-free intravenous solution container, shall meet the requirement in subdivision (a) by January 1, 2032, if all of the following conditions are met:

(1) The person or entity notified its California customers, no later than July 1, 2025, that it has commenced development of the DEHP-free intravenous solution container to meet the requirements of this section.

(2) The person or entity provides notice to its customers and posts to its official internet website, no later than January 1, 2028, that it will not meet the deadline imposed pursuant to subdivision (a).


text:
The effective diagnosis, care, treatment or cure of persons suffering from cancer is of paramount public importance. Vital statistics indicate that approximately 16 percent of the total deaths in the United States annually result from one or another of the forms of cancer. It is established that accurate and early diagnosis of many forms of cancer, followed by prompt application of methods of treatment that are scientifically proven, either materially reduces the likelihood of death from cancer or may materially prolong the useful life of individuals suffering therefrom.

Despite intensive campaigns of public education, there is a lack of adequate and accurate information among the public with respect to presently proven methods for the diagnosis, treatment, and cure of cancer. Various persons in this state have represented and continue to represent themselves as possessing medicines, methods, techniques, skills, or devices for the effective diagnosis, treatment, or cure of cancer, whose representations are misleading to the public, with the result that large numbers of the public, relying on the representations, needlessly die of cancer, and substantial amounts of the savings of individuals and families relying on the representations are needlessly wasted.

It is, therefore, in the public interest that the public be afforded full and accurate knowledge as to the facilities and methods for the diagnosis, treatment, and cure of cancer available in this state and that to that end there be provided means for testing and investigating the value or lack thereof of alleged cancer remedies, devices, drugs, or compounds, and informing the public of the facts found, and protecting the public from misrepresentation in these matters.

The importance of continuing scientific research to determine the cause or cure of cancer is recognized, and the department shall administer this article and Article 2 (commencing with Section 109300) with due regard for the importance of bona fide scientific research and the clinical testing in hospitals, clinics, or similar institutions of new drugs or compounds.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

part: 4. DRUGS, DEVICES, AND COSMETICS

article: 1. Intent and Definitions

path: 104. ENVIRONMENTAL HEALTH > 4. DRUGS, DEVICES, AND COSMETICS > 4. Treatment of Cancer and Other Serious Diseases > 1. Intent and Definitions


text: There is in the department a Cancer Advisory Council composed of nine physicians and surgeons licensed to practice medicine in, and residing in, this state, three persons who are not physicians and surgeons, two persons representing nonprofit cancer research institutes recognized by the National Cancer Institute, and the director of the department, who shall be an ex officio member. The members of the council shall be appointed by the Governor to serve for terms of four years. The Governor, in appointing the first members, shall appoint at least one member from the faculty of each of the schools teaching medicine and surgery and located in this state that are approved by the Medical Board of California. The Governor shall endeavor to maintain one member from the faculty of each school in making subsequent appointments.

chapter: 4. Treatment of Cancer and Other Serious Diseases

article: 1. Intent and Definitions


text:
The members of the council, other than the director of the department, shall receive no compensation for their services, but shall be allowed their actual necessary traveling expenses incurred in the discharge of their duties.

Except as provided in Section 109390 the council is not required to conduct meetings open to the public in accordance with Article 9 (commencing with Section 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government Code.

article: 1. Intent and Definitions


text: The council shall annually elect one of its members to serve as chairman. The council shall meet at least twice each year, and as often in addition as necessary, for the purpose of carrying out its duties.

article: 1. Intent and Definitions


text:
The department shall:

(a) Prescribe reasonable regulations with respect to the administration of this article and Article 2 (commencing with Section 109300).

(b) Investigate violations of this article and Article 2 (commencing with Section 109300), and report the violations to the appropriate enforcement authority.

(c) Secure the investigation and testing of the content, method of preparation, efficacy, or use of drugs, medicines, compounds, or devices proposed to be used, or used, by any individual, person, firm, association, or other entity in the state for the diagnosis, treatment, or cure of cancer, prescribe reasonable regulations with respect to the investigation and testing, and make findings of fact and recommendations upon completion of any such investigation and testing.

(d) Adopt a regulation prohibiting the prescription, administration, sale or other distribution of any drug, substance, or device found to be harmful or of no value in the diagnosis, prevention or treatment of cancer.

(e) Hold hearings in respect of those matters involving compliance with this article and Article 2 (commencing with Section 109300) and subpoena witnesses and documents. Any or all hearings may be held before the Cancer Advisory Council. Any administrative action to be taken by the department as a result of the hearings shall be taken only after receipt of the recommendations of the council. Prior to issuance of a cease and desist order under Section 109345, a hearing shall be held. The person furnishing a sample under Section 109295 shall be given due notice of the hearing and an opportunity to be heard.

(f) Contract with independent scientific consultants for specialized services and advice.

In the exercise of the powers granted by this section, the department shall consult with the Cancer Advisory Council.

article: 1. Intent and Definitions


text:
(a) Upon a diagnosis of breast cancer, the physician and surgeon, meaning the primary provider who initially referred the patient for the screening or biopsy or, if different, the provider who has made the diagnosis of breast cancer and initially consulted with the patient about treatment, shall give the patient the written summary described in subdivision (c) and required by this section and shall note on the patient’s chart that he or she has given the patient the written summary. The physician and surgeon may choose to provide the summary prior to the performance of a screening or biopsy for breast cancer upon a patient’s request or at the discretion of the physician and surgeon in appropriate cases, including, but not limited to, instances when a patient has demonstrated risk factors, has a family history of breast cancer, or is otherwise susceptible.

(b) The failure of a physician and surgeon to inform a patient, by means of a standardized written summary developed by the department on the recommendation of the Cancer Advisory Council in accordance with subdivision (c), in layperson’s language and in a language understood by the patient, of alternative efficacious methods of treatment that may be medically viable, including surgical, radiological, or chemotherapeutic treatments or combinations thereof, when the patient is being treated for any form of breast cancer, constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code.

(c) (1) A standardized written summary in layperson’s language and in a language understood by the patient shall be developed by the department with the recommendations of the Cancer Advisory Council, and shall be printed and made available by the Medical Board of California to physicians and surgeons, for the purposes of informing the patient of the advantages, disadvantages, risks, and descriptions of the procedures with regard to medically viable and efficacious alternative methods of treatment for breast cancer as required by subdivision (a).

(2) Commencing no later than January 1, 1995, and every three years thereafter, the department shall review the written summary and shall revise the written summary if the department determines that new or revised information should be included in the written summary, and shall provide a copy of the revised summary to the Medical Board of California.

(3) At the next revision of the standardized written summary required by this section, the department shall incorporate all of the following additional information:

(A) Information regarding methods of treatment for breast cancer that are in the investigational or clinical trial stage and are recognized for treatment by the Physician’s Data Query of the National Cancer Institute.

(B) Available reference numbers, including, but not limited to, the “800” telephone numbers for the National Cancer Institute and the American Cancer Society, in order for breast cancer patients to obtain the most recent information.

(C) A discussion of breast reconstruction surgery, including, but not limited to, problems, benefits, and alternatives.

(D) Statistics on the incidence of breast cancer.

(d) The Medical Board of California shall establish a distribution system for the breast cancer treatment alternatives written summary, and shall provide a link to its Internet Web site that may be accessed by consumers interested in viewing and obtaining a copy of the summary.

(e) The department and the Medical Board of California shall each post the summary on its Internet Web site.

history: (History: Amended by Stats. 2006, Ch. 485, Sec. 1. Effective January 1, 2007.)

article: 1. Intent and Definitions


text: In the first revision of the standardized written summary required under subdivision (c) of Section 109275 made following the effective date of the act that added this section, the State Department of Health Care Services shall incorporate information relating to breast cancer susceptibility gene (BRCA) mutations, in order to achieve increased genetic counseling and screening rates of individuals for whom BRCA test results can inform treatment decisions, consistent with evidence-based national recommendations.

history: (History: Added by Stats. 2017, Ch. 693, Sec. 2. (AB 1386) Effective January 1, 2018.)

article: 1. Intent and Definitions


text:
(a) Every person or entity who owns or operates a health facility or a clinic, or who is licensed as a physician and surgeon and rents or owns the premises where his or her practice is located, shall cause a sign or notice to be posted where a physician and surgeon performs breast cancer screening or biopsy as an outpatient service, or in a reasonably proximate area to where breast cancer screening or biopsy is performed. A sign or notice posted at the patient registration area of the health facility, clinic, or physician and surgeon’s office shall constitute compliance with this section.

(b) The sign or notice shall read as follows:

“BE INFORMED”

“Upon a diagnosis of breast cancer, your physician and surgeon is required to provide you a written summary of alternative efficacious methods of treatment, pursuant to Section 109275 of the California Health and Safety Code. Your physician and surgeon may choose to provide the summary prior to the performance of a screening or biopsy for breast cancer at your request or at the physician and surgeon’s discretion, when appropriate.”

“The information about methods of treatment was developed by the State Department of Public Health to inform patients of the advantages, disadvantages, risks, and descriptions of procedures.” (c) The sign shall be not less than eight and one-half inches by 11 inches and shall be conspicuously displayed so as to be readable. The words “BE INFORMED” shall not be less than one-half inch in height and shall be centered on a single line with no other text. The message on the sign shall appear in English, Spanish, and Chinese.

history: (History: Amended by Stats. 2007, Ch. 483, Sec. 22. Effective January 1, 2008.)

article: 1. Intent and Definitions


text:
(a) The medical care provider primarily responsible for providing to a patient an annual gynecological examination shall provide to that patient during the annual examination a standardized summary in layperson’s language and in a language understood by the patient containing a description of the symptoms and appropriate methods of diagnoses for gynecological cancers. Use of existing publications developed by nationally recognized cancer organizations is not precluded by this section.

(b) For the purposes of this section, “medical care provider” means a health care professional licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code or pursuant to an initiative act referred to in that division providing medical care within his or her lawful scope of practice.

history: (History: Added by Stats. 1997, Ch. 754, Sec. 2. Effective January 1, 1998.)

article: 1. Intent and Definitions


text:
(a) A standardized written summary in layperson’s language and in a language understood by patients shall be approved by the department. The department may approve the use of an existing publication from a recognized cancer authority as the written summary. Commencing on January 1, 2003, and every three years thereafter, the department shall review its approval of the use of an existing publication from a recognized cancer authority as the written summary to ensure that the approved written summary comprises timely, new, and revised information regarding prostate cancer treatment options as the department determines is necessary. The written summary shall be printed or made available by the Medical Board of California to physicians and surgeons, concerning the advantages, disadvantages, risks, and descriptions of procedures with regard to medically viable and efficacious alternative methods of treatment of prostate cancer. Physicians and surgeons are urged to make the summary available to patients when appropriate.

(b) The department and the Medical Board of California shall each post this summary on its Internet Web site for public use.

(c) If the department updates this summary, it shall send the updated summary to the Medical Board of California and both the department and the Medical Board of California shall each post this updated summary on its Internet Web site.

history: (History: Amended by Stats. 2007, Ch. 130, Sec. 171. Effective January 1, 2008.)

article: 1. Intent and Definitions


text:
(a) Every person or entity who owns or operates a health facility or a clinic, or who is licensed as a physician and surgeon and rents or owns the premises where his or her practice is located, shall cause a sign or notice to be posted where prostate cancer screening or treatment is performed by any physician and surgeon, or in a reasonably proximate area to where prostate cancer screening or treatment is performed. A sign or notice posted at the patient registration area of the health facility, clinic, or physician and surgeon’s office shall constitute compliance with this section.

(b) The sign or notice shall read as follows:

“BE INFORMED”

“If you are a patient being treated for any form of prostate cancer, or prior to performance of a biopsy for prostate cancer, your physician and surgeon is urged to provide you a written summary of alternative efficacious methods of treatment, pursuant to Section 109280 of the California Health and Safety Code.”

“The information about methods of treatment was developed by the State Department of Public Health to inform patients of the advantages, disadvantages, risks, and descriptions of procedures.” (c) The sign shall be not less than eight and one-half inches by 11 inches and shall be conspicuously displayed so as to be readable. The words “BE INFORMED” shall not be less than one-half inch in height and shall be centered on a single line with no other text. The message on the sign shall appear in English, Spanish, and Chinese.

(d) Subject to future, regular production and replacement schedules from the implementation of the act adding this subdivision, these signs and notices shall include the Internet Web site address of the State Department of Public Health and the Medical Board of California, and a notice regarding the availability of updated prostate cancer summaries on these Web sites.

history: (History: Amended by Stats. 2006, Ch. 241, Sec. 33. Effective January 1, 2007. Operative July 1, 2007, by Sec. 37 of Ch. 241.)

article: 1. Intent and Definitions


text: For the purposes of this article and Article 2 (commencing with Section 109300) “cancer” means all malignant neoplasms regardless of the tissue of origin, including malignant lymphoma, Hodgkins disease, and leukemia.

article: 1. Intent and Definitions


text: No person may undertake to treat or alleviate cancer by use of drugs, surgery, or radiation unless the person holds a license issued under a law of this state expressly authorizing the diagnosis and treatment of disease by use of drugs, surgery, or radiation.

article: 1. Intent and Definitions


text:
On written request by the department, delivered personally or by mail, any individual, person, firm, association, or other entity engaged, or representing himself, or itself, as engaged, in the diagnosis, treatment, alleviation, or cure of cancer shall furnish the department with the sample as the department may deem necessary for adequate testing of any drug, medicine, compound, or device used or prescribed by the individual, person, firm, association, or other entity in the diagnosis, treatment, alleviation, or cure of cancer, and shall specify the formula of any drug or compound and name all ingredients by their common or usual names, and shall, upon like request by the department, furnish further necessary information as it may request as to the composition and method of preparation of and the use that any drug, compound, or device is being put by the individual, person, firm, association, or other entity. This section shall apply to any individual, person, firm, association, or other entity that renders health care or services to individuals who have or believe they have cancer. This section also applies to any individual, person, firm, association, or other entity that by implication causes individuals to believe they have cancer.

The failure to either provide the sample, disclose the formula, or name the ingredients as required by this section shall be conclusively presumed that the drug, medicine, compound or device that is the subject of the department’s request has no value in the diagnosis, treatment, alleviation, or cure of cancer.

article: 1. Intent and Definitions


text:
The sale, offering for sale, holding for sale, delivering, giving away, prescribing or administering of any drug, medicine, compound, or device to be used in the diagnosis, treatment, alleviation, or cure of cancer is unlawful and prohibited unless (1) an application with respect thereto has been approved under Section 505 of the federal Food, Drug and Cosmetic Act, or (2) there has been approved an application filed with the board setting forth:

(a) Full reports of investigations that have been made to show whether or not the drug, medicine, compound, or device is safe for the use, and whether the drug, medicine, compound, or device is effective in the use;

(b) A full list of the articles used as components of the drug, medicine, compound, or device;

(c) A full statement of the composition of the drug, medicine, compound, or device;

(d) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug, medicine, or compound or in the case of a device, a full statement of its composition, properties, and construction and the principle or principles of its operation;

(e) Such samples of the drug, medicine, compound, or device and of the articles used as components of the drug, medicine, compound, or device as the board may require; and

(f) Specimens of the labeling and advertising proposed to be used for the drug, medicine, compound, or device.

article: 2. Prohibitions and Enforcement

path: 104. ENVIRONMENTAL HEALTH > 4. DRUGS, DEVICES, AND COSMETICS > 4. Treatment of Cancer and Other Serious Diseases > 2. Prohibitions and Enforcement


text:
Within 180 days after the filing of an application provided for in subdivision (2) of Section 109300 or an additional period as may be agreed upon by the board and the applicant, the board shall either:

(a) Approve the application if it finds that none of the grounds for denying approval specified in Section 109315 applies.

(b) Give the applicant notice for an opportunity for a hearing before the board on the question whether the application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after the notice, the hearing shall commence not more than 90 days after the expiration of the 30 days unless the board and the applicant otherwise agree. Any hearing shall thereafter be conducted on an expedited basis and the board order thereon shall be issued within 90 days after the date fixed by the board for filing final briefs.

Prior to approving the application or giving the applicant notice for an opportunity for a hearing, the board shall have received a written report from the Cancer Advisory Council setting forth its recommendations on the action the board should take. The report shall be signed by a majority of the members of the council.

article: 2. Prohibitions and Enforcement


text:
In the case of any drug, medicine, compound or device for that an approval of an application filed pursuant to this article and Article 1 (commencing with Section 109250) is in effect, the applicant shall establish and maintain the records, and make the reports to the board, of data relating to clinical experience and other data or information, received or otherwise obtained by the applicant with respect to the drug, medicine, compound, or device, as the board may prescribe on the basis of a finding that the records and reports are necessary in order to enable the board to determine, or facilitate a determination, whether there is or may be ground for suspension of the application.

Every person required under this section to maintain records, and every person in charge of custody thereof, shall, upon request of an agent of the board, permit the agent at all reasonable times to have access to and copy and verify the records.

article: 2. Prohibitions and Enforcement


text:
The board shall issue an order refusing to permit the application to become effective, if, after due notice to the applicant and opportunity for a hearing, the board finds any of the following:

(a) The investigations, reports that are required to be submitted to the board pursuant to subdivision (2) of Section 109300 do not include adequate tests by all methods reasonably applicable to show whether or not a drug, medicine, compound, or device is safe for use in the diagnosis, treatment, alleviation, or cure of cancer.

(b) The results of tests specified in subdivision (a) show that a drug, medicine, compound or device is unsafe for use under the conditions specified in subdivision (a) or do not show that the drug, medicine, compound, or device is safe for use under the conditions.

(c) The methods used in, and the facilities and controls used for, the manufacture, processing, and packing of a drug, medicine, compound, or device are inadequate to preserve its identity, strength, quality, and purity and with respect to a device are inadequate to preserve its safety or effectiveness.

(d) Upon the basis of the information submitted to it as part of the application, or upon the basis of any other information before it with respect to a drug, medicine, compound, or device, it has insufficient evidence to determine whether the drug, medicine, compound, or device is safe for use under the conditions specified in subdivision (a).

(e) Evaluated on the basis of the information submitted to it as part of the application and any other information before it with respect to the drug, medicine, compound, or device, there is a reasonable doubt that the drug, medicine, compound, or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling or advertising thereof.

(f) The application contains any untrue statement of a material fact.

article: 2. Prohibitions and Enforcement


text:
(a) The board shall issue an order withdrawing approval of an application concerning any drug, medicine, compound, or device if, after due notice to the applicant and opportunity for a hearing, the board finds any of the following:

(1) That clinical or other experience, tests, or other scientific data show that the drug, medicine, compound, or device is unsafe for use under the conditions of use upon the basis that the application was approved;

(2) That new evidence of clinical experience, not contained in the application or not available to the board until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available to the board when the application was approved, shows that the drug, medicine, compound, or device is not shown to be safe for use under conditions of use upon the basis that the application was approved; or

(3) On the basis of new information with respect to the drug, medicine, compound, or device, evaluated together with the evidence available to the board when the application was approved, that there is a lack of substantial evidence that the drug, medicine, compound, or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or advertising thereof; or

(4) That the application contains any untrue statement of a material fact.

(b) If the board finds that there is an imminent hazard to the public health, it may suspend the approval of the application immediately.

(c) The board may also, after due notice and opportunity for hearing, withdraw the approval of an application with respect to any drug, medicine, compound, or device under this section if the board finds any of the following:

(1) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain the records or to make required reports, or the applicant has refused to permit access to, or copying or verification of, the records.

(2) That on the basis of new information before the board, evaluated together with the evidence before it when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, maintenance, processing, and packing of the drug, medicine, compound, or device are inadequate to assure and preserve its identity, strength, quality, and purity and with respect to a device are inadequate to preserve its safety or effectiveness and were not made adequate within a reasonable time after receipt of written notice from the board specifying the matter complained of.

(3) That on the basis of new information before it, evaluated together with the evidence before it when the application was approved, the labeling of the drug, medicine, compound, or device, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the board specifying the matter complained of.

(d) Any order under this section shall state the findings upon which it is based.

article: 2. Prohibitions and Enforcement


text:
This article and Article 1 (commencing with Section 109250) shall not apply to the use of any drug, medicine, compound, or device intended solely for legitimate and bona fide investigational purposes by experts qualified by scientific training and experience to investigate the safety and therapeutic value thereof unless the department shall find that the drug, medicine, compound, or device is being used in diagnosis or treatment for compensation and profit. In order to qualify for an exemption under this section there shall be on file with the federal Department of Health, Education, and Welfare a current and unrevoked investigational new drug application issued pursuant to subdivision (i) of Section 505 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355(i)), or the following conditions shall be complied with:

(a) The label of the drug, medicine, compound, or device shall bear the statement “Caution: New drug (or medicine or compound or device). Use in the diagnosis, treatment, alleviation, or cure of cancer limited by law to investigational use.”

(b) The drug, medicine, compound, or device has had adequate testing on appropriate experimental animals to demonstrate a lack of toxicity and hazard sufficient to permit its use in or on human beings and to establish with clarity the margins of safety ordinarily recognized by experts qualified by scientific training and experience to investigate the safety and effectiveness of the drugs, substances, or devices.

(c) The drug, medicine, compound, or device is to be used solely for investigational use by, or under the direction of, an expert qualified by scientific training and experience to investigate the safety and effectiveness of the drug, medicine, compound, or device.

(d) A written statement signed by the expert has been filed with the board. The statement shall show what facilities the expert will use for the investigation to be conducted by him or her, and that the drug, medicine, compound, or device will be used solely by him or her or under his or her direction for the investigation. The statement shall contain information identifying any assistant or agent of the expert who uses the drug, medicine, compound, or device under the direction of the expert.

(e) Complete records of the investigation shall be kept by the expert and all records shall be made available by the expert for inspection upon the request of any agent of the board at any reasonable hour as long as the expert desires exemption.

(f) The expert shall inform any persons who participate in the investigation as patients, that the drug, medicine, compound, or device is being used for investigational purposes and shall obtain the consent of the persons or their representatives.

article: 2. Prohibitions and Enforcement


text: Section 109300 does not apply to any device used within the scope of his or her license privileges by a physician and surgeon or dentist licensed as such in this state.

article: 2. Prohibitions and Enforcement


text:
The failure of any individual, person, firm, association, or other entity representing himself, or itself, as engaged in the diagnosis, treatment, alleviation, or cure of cancer to comply with any of the regulations adopted under this article and Article 1 (commencing with Section 109250) is a misdemeanor. A third, and subsequent violations, of this section is a felony, punishable by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code.

This article and Article 1 (commencing with Section 109250) shall not apply to any person who depends exclusively upon prayer for healing in accordance with the teachings of a bona fide religious sect, denomination, or organization, nor practitioner thereof.

history: (History: Amended by Stats. 2011, Ch. 15, Sec. 199. (AB 109) Effective April 4, 2011. Operative October 1, 2011, by Sec. 636 of Ch. 15, as amended by Stats. 2011, Ch. 39, Sec. 68.)

article: 2. Prohibitions and Enforcement


text: The investigation or testing of any product shall not be deemed to imply or indicate any endorsement of the qualifications or value of any product. No person shall make any representation that investigation or testing hereunder constitutes any approval or endorsement of his or her, or its, activities by the Cancer Advisory Council or the department. The investigation or testing of any product shall not be deemed to imply or indicate that the product is useless or harmful and during testing no person shall make any representation, except to the department or Cancer Advisory Council, that the product under test is discredited or that it has been found useless or harmful.

article: 2. Prohibitions and Enforcement


text:
Following an investigation or testing of the content or composition of any drug, medicine, compound, or device used by any individual, person, firm, association, or other entity in the diagnosis, treatment, alleviation, or cure of cancer, and after hearing as provided in Section 109270, the department, upon recommendation of the Cancer Advisory Council, may direct that any individual, person, firm, association, or other entity shall cease and desist any further prescribing, recommending, or use of any drug, medicine, compound, or device, or any substantially similar drug, medicine, compound, or device, in the diagnosis or treatment of cancer.

In the investigation or testing required by this article and Article 1 (commencing with Section 109250) to determine the value or lack thereof of any drug, medicine, compound or device in the diagnosis, treatment, or cure of cancer, the department shall, as it deems necessary or advisable, utilize the facilities and findings of its own laboratories or other appropriate laboratories, clinics, hospitals, and nonprofit cancer research institutes recognized by the National Cancer Institute, within this State or the facilities and findings of the Federal Government, including the National Cancer Institute. Upon a recommendation by the Cancer Advisory Council, the department shall arrange, by contract, for investigation by and submission to it of findings, conclusions, or opinions of trained scientists in the appropriate departments of universities, medical schools, clinics, hospitals, and nonprofit cancer research institutes recognized by the National Cancer Institute, and the submission to it of findings, conclusions, or opinions of other qualified scientists. Prior to the issuance of a cease and desist order under this section, the Cancer Advisory Council, by the affirmative vote of at least 11 of its members, at least one of whom shall not be a physician and surgeon, shall make a written finding of fact based on the investigation that the drug, medicine, compound, or device so investigated has been found to be either definitely harmful or of no value in the diagnosis, treatment, alleviation, or cure of cancer and the department must be satisfied beyond a reasonable doubt that the written findings of the fact are true.

article: 2. Prohibitions and Enforcement


text: The department may direct that any individual, person, firm, association, or other entity shall cease and desist any further prescribing, recommending, or use of any drug, medicine, compound, or device for which no application has been approved under this article and Article 1 (commencing with Section 109250) unless its use is exempt under Section 109325 or 109330.

history: (History: Amended by Stats. 2006, Ch. 538, Sec. 423. Effective January 1, 2007.)

article: 2. Prohibitions and Enforcement


text:
(a) Any violation of this article and Article 1 (commencing with Section 109250), of the regulations adopted thereunder or of a cease and desist order issued by the department under Section 109345 or 109350 may be enjoined by the superior court in any county, on application of the department.

(b) Proceedings under this section shall be governed by Chapter 3 (commencing with Section 525) of Title 7 of Part 2 of the Code of Civil Procedure.

article: 2. Prohibitions and Enforcement


text: Any person against whom an injunction or cease and desist order has been issued, under this article and Article 1 (commencing with Section 109250), may not undertake to use in the diagnosis, treatment, alleviation, or cure of cancer any new, experimental, untested, or secret drug, medicine, compound, or device for which there is no approved application on file or that does not qualify for an exemption, without first submitting an application to the department.

history: (History: Amended by Stats. 2006, Ch. 538, Sec. 424. Effective January 1, 2007.)

article: 2. Prohibitions and Enforcement


text: It is unlawful for any person, with the intent to defraud, to falsely represent and provide for compensation a device, substance, method or treatment as effective to diagnose, arrest, prevent, or cure cancer. Nothing in this section shall abridge the existent rights of the press.

article: 2. Prohibitions and Enforcement


text: Except as provided in Section 109335, a violation of this article and Article 1 (commencing with Section 109250) is punishable by imprisonment in the county jail for a period not exceeding one year, or in the state prison, or by a fine not exceeding ten thousand dollars ($10,000), or by both the imprisonment and fine.

article: 2. Prohibitions and Enforcement


text: The director shall investigate possible violations of this article and Article 1 (commencing with Section 109250) and report violations to the appropriate enforcement authority.

article: 2. Prohibitions and Enforcement


text: County health officers, district attorneys and the Attorney General shall cooperate with the director in the enforcement of this article and Article 1 (commencing with Section 109250).

article: 2. Prohibitions and Enforcement


text: The department, upon recommendation of the Cancer Advisory Council, may from time to time publish reports based on its investigation or testing of any drug, medicine, compound, or device prescribed, recommended, or used by any individual, person, firm, association, or other entity, and when, in the opinion of a majority of the members of the Cancer Advisory Council, the use of any drug, medicine, compound, or device in the diagnosis, treatment or cure of cancer constitutes an imminent danger to health or a gross deception of the public, the department may take appropriate steps to publicize the same.

article: 2. Prohibitions and Enforcement


text: All hearings authorized by this article and Article 1 (commencing with Section 109250) shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1, Division 3, Title 2 of the Government Code.

article: 2. Prohibitions and Enforcement


text: No provision of this article and Article 1 (commencing with Section 109250) shall preclude reconsideration of an application for use of any drug, medicine, compound or device for the diagnosis, treatment, alleviation or cure of cancer if new evidence or matter is presented to the department and the reconsideration is predicated upon compliance with the applicable sections of the law, and presentation of data developed subsequent to the applicable ruling of the board.

article: 2. Prohibitions and Enforcement


text: As used in this article, “DMSO” means dimethyl sulfoxide.

article: 5. Labeling, Sale, and Use of DMSO

path: 104. ENVIRONMENTAL HEALTH > 4. DRUGS, DEVICES, AND COSMETICS > 4. Treatment of Cancer and Other Serious Diseases > 5. Labeling, Sale, and Use of DMSO


text:
DMSO sold in California other than by prescription shall be labeled by the manufacturer, distributor, or seller to contain a description of all of the contents in the solution, statement of purity, the percent of DMSO in the solution, and the manufacturer’s name and address.

The label shall contain (a) the name and address of the distributor of the DMSO, if any, (b) the name and address of the manufacturer of the finished DMSO, and (c) the manufacturer’s lot or control number. Finished DMSO means DMSO that requires no further manufacture prior to retail sale other than packaging or labeling. Whenever DMSO is sold or otherwise supplied, other than by prescription, the seller or supplier shall give additional printed material to the person receiving the DMSO that provides adequate warning against use that may be dangerous to the health of the user, and information that prescriptive DMSO is available from a physician.

The label of DMSO sold pursuant to this section shall contain the following statement: “It is unlawful to represent in any way that this product is useful or safe to use for medicinal purposes.” The label shall include appropriate precautionary measures for proper handling and first aid treatment and a warning statement to keep the product out of reach of children.

article: 5. Labeling, Sale, and Use of DMSO


text: This chapter shall be known as the “California Imitation Controlled Substances Act.”

chapter: 5. Imitation Controlled Substances

article: 1. Provisions and Definitions

path: 104. ENVIRONMENTAL HEALTH > 4. DRUGS, DEVICES, AND COSMETICS > 5. Imitation Controlled Substances > 1. Provisions and Definitions


text: Unless the context otherwise requires, the definitions in this article govern the construction of this chapter.

article: 1. Provisions and Definitions


text: “Controlled substance” means a substance as defined in Section 11007.

article: 1. Provisions and Definitions


text: “Distribute” means the actual, constructive, or attempted transfer, delivery, or dispensing to another of an imitation controlled substance.

article: 1. Provisions and Definitions


text: “Manufacture” means the production, preparation, compounding, processing, encapsulating, packaging or repackaging, labeling or relabeling, of an imitation controlled substance.

article: 1. Provisions and Definitions


text: “Imitation controlled substance” means (a) a product specifically designed or manufactured to resemble the physical appearance of a controlled substance, that a reasonable person of ordinary knowledge would not be able to distinguish the imitation from the controlled substance by outward appearances, or (b) a product, not a controlled substance, that, by representations made and by dosage unit appearance, including color, shape, size, or markings, would lead a reasonable person to believe that, if ingested, the product would have a stimulant or depressant effect similar to or the same as that of one or more of the controlled substances included in Schedules I through V, inclusive, of the Uniform Controlled Substances Act, pursuant to Chapter 2 (commencing with Section 11053) of Division 10.

article: 1. Provisions and Definitions


text: The provisions of this chapter are cumulative, and shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of any party.

article: 1. Provisions and Definitions


text: Any person who knowingly manufactures, distributes, or possesses with intent to distribute, an imitation controlled substance is guilty of a misdemeanor and shall, if convicted, be subject to imprisonment for not more than six months in the county jail or a fine of not more than one thousand dollars ($1,000), or both the imprisonment and fine.

article: 2. Offenses and Penalties

path: 104. ENVIRONMENTAL HEALTH > 4. DRUGS, DEVICES, AND COSMETICS > 5. Imitation Controlled Substances > 2. Offenses and Penalties


text: Any person 18 years of age or over who violates Section 109575 by knowingly distributing an imitation controlled substance to a person under 18 years of age is guilty of a misdemeanor and shall, if convicted, be punished by imprisonment for not more than one year in a county jail or a fine of not more than two thousand dollars ($2,000), or by both that imprisonment and fine. Upon a second or subsequent conviction of this offense, the person shall be subject to imprisonment for not more than one year in a county jail and a fine of not less than six thousand dollars ($6,000).

history: (History: Amended by Stats. 2001, Ch. 854, Sec. 17. Effective January 1, 2002.)

article: 2. Offenses and Penalties


text: No civil or criminal liability shall be imposed by virtue of this chapter on any person registered under the California Uniform Controlled Substances Act who manufactures, distributes, or possesses an imitation controlled substance for use by a practitioner, as defined in Section 11026, in the course of lawful professional practice or research.

article: 2. Offenses and Penalties


text: All imitation controlled substances shall be subject to forfeiture in accordance with the procedures set forth in Chapter 8 (commencing with Section 11470) of Division 10.

article: 2. Offenses and Penalties


text: This part shall be known as the Sherman Food, Drug, and Cosmetic Law.

chapter: 1. General Provisions and Definitions

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 1. General Provisions and Definitions


text: Unless the context otherwise requires, the definitions set forth in this article govern the construction of this part.

part: 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS


text: “Advertisement” means any representations, including, but not limited to, statements upon the products, its packages, cartons, and any other container, disseminated in any manner or by any means, for the purpose of inducing, or that is likely to induce, directly or indirectly, the purchase or use of any food, drug, device, or cosmetic.


text: “Antibiotic drug” means any drug , except drugs for use in animals other than humans, composed in whole or in part of any form of penicillin, streptomycin, chlortetracycline chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance that is produced by micro-organisms, and that has the capacity to inhibit or destroy micro-organisms in dilute solution, including a chemically synthesized equivalent, or any derivative thereof.

history: (History: Amended by Stats. 2000, Ch. 796, Sec. 1. Effective January 1, 2001.)


text:
“Color additive” means a substance that satisfies both of the following requirements:

(a) It is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source.

(b) When added or applied to a food, drug, device, or cosmetic, or to the human body or any part of the body, it is capable, alone or through reaction with any other substance, of imparting color to the food, drug, device, or cosmetic, or to the human body or the part of the human body, to which it is added or applied.

The term “color additive” does not include any material that the department, by regulation, determines is used, or intended to be used, solely for a purpose or purposes other than coloring.

The term “color,” as used in this section, includes black, white, and intermediate grays.

This section does not apply to any pesticide chemical, soil, or plant nutrient, or other agricultural chemical, solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological process of produce of the soil and thereby affecting its color, whether before or after harvest.


text:
“Cosmetic” means any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance.

The term “cosmetic” does not include soap.


text: “Counterfeit”, as used in respect to any food, drug, device, or cosmetic, means a food, drug, device, or cosmetic that bears or whose package or labeling bears, without authorization, the trademark, trade name, or other identifying mark, imprint, or device, or any likeness or trademark, trade name, or other identifying mark, imprint, or device of a manufacturer, processor, packer, or distributor, other than the actual manufacturer, processor, packer, or distributor, or that falsely purports or is represented to be the product of, or to have been packed or distributed by, the other manufacturer, processor, packer, or distributor.


text: “Department” means the State Department of Health Services.


text: “Director” means the State Director of Health Services.


text:
“Device” means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is any of the following:

(a) Recognized in the official National Formulary or the United States Pharmacopoeia, or any supplement to them.

(b) Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in humans or any other animal.

(c) Intended to affect the structure or any function of the body of humans or any other animal and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and that is not dependent upon being metabolized for the achievement of any of its principal intended purposes.


text:
(a) “Drug” means any of the following:

(1) An article recognized in an official compendium.

(2) An article used or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or any other animal.

(3) An article other than food, that is used or intended to affect the structure or any function of the body of human beings or any other animal.

(4) An article used or intended for use as a component of an article designated in paragraphs (1) to (3), inclusive.

(b) The term “drug” does not include any device.

(c) Any food for which a claim (as described in Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(3) (21 U.S.C. Sec. 343(r)(3)) or Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(5)(D) (21 U.S.C. Sec. 343(r)(5)(D)) of the federal act), is made in accordance with the requirements set forth in Section 403(r) (21 U.S.C. Sec. 343(r)) of the federal act, is not a drug under subdivision (b) solely because the label or labeling contains such a claim.

(d) Cannabis product, including any cannabis product intended for external use, is not a drug.

history: (History: Amended by Stats. 2017, Ch. 27, Sec. 160. (SB 94) Effective June 27, 2017.)


text: “Federal act” means the federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. Sec. 301 et seq.).


text:
“Food” means either of the following:

(a) Any article used or intended for use for food, drink, confection, condiment, or chewing gum by man or other animal.

(b) Any article used or intended for use as a component of any article designated in subdivision (a).

history: (History: Amended by Stats. 2001, Ch. 641, Sec. 1. Effective January 1, 2002.)


text:
“Food additive” means any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in the substance becoming a component of the food or otherwise affecting characteristics of the food. This includes any substance or radiation source intended for use in producing, manufacturing, packing, treating, packaging, transporting, or holding any food.

The term “food additive” does not include any of the following:

(a) A pesticide chemical in or on a raw agricultural commodity.

(b) A pesticide chemical that is used, or intended for use, in the production, storage, or transportation of any raw agricultural commodity.

(c) A color additive.

(d) Any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 (72 Stat. 1784), pursuant to the federal act; the Poultry Products Inspection Act (71 Stat. 441; 21 U.S.C. Sec. 451 et seq.); the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. Sec. 71 et seq.); or the Food and Agricultural Code of this state.


text: “Food and drug inspector” means any authorized agent of the Bureau of Food and Drug of the department, who shall have the powers set forth in Section 106500.


text: “Food processing facility” means any facility operated for the purposes of manufacturing, packing, or holding processed food. Food processing facility does not include a food facility as defined in Section 113785, a cottage food operation that is registered or has a permit pursuant to Section 114365, or any facility exclusively storing, handling, or processing dried beans.

history: (History: Amended by Stats. 2012, Ch. 415, Sec. 3. (AB 1616) Effective January 1, 2013.)


text:
(a) “Home medical device retail facility” is an area, place, or premises, other than a licensed pharmacy, in and from which prescription devices, home medical devices, or home medical device services are sold, fitted, or dispensed pursuant to prescription. “Home medical device retail facility” includes, but is not limited to, any area or place in which prescription devices, home medical devices, or home medical device services are stored, possessed, prepared, manufactured, or repackaged, and from which the prescription devices, home medical devices, and home medical device services are furnished, sold, or dispensed at retail.

(b) “Home medical device retail facility” shall not include any area in a facility licensed by the department where floor supplies, ward supplies, operating room supplies, or emergency room supplies of prescription devices are stored or possessed solely for treatment of patients registered for treatment in the facility or for treatment of patients receiving emergency care in the facility.

(c) “Home medical device retail facility” shall not include any area of a home health agency licensed under Chapter 8 (commencing with Section 1725) of, or a hospice licensed under Chapter 8.5 (commencing with Section 1745) of Division 2 where the supplies specified in subdivision (c) of Section 4057 of the Business and Professions Code are stored or possessed solely for treatment of patients by a licensed home health agency or licensed hospice, as long as all prescription devices are furnished to these patients only upon the prescription or order of health care practitioners authorized to prescribe or order home medical devices or who use home medical devices or who use home medical devices to treat their patients.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 28. Effective January 1, 2001.)


text:
(a) “Home medical device services” means the delivery, installation, maintenance, replacement of, or instruction in the use of, home medical devices used by a sick or disabled individual to allow the individual to be maintained in a residence.

(b) “Home medical device” means a device intended for use in a home care setting including, but not limited to, all of the following:

(1) Oxygen delivery systems and prefilled cylinders.

(2) Ventilators.

(3) Continuous Positive Airway Pressure devices (CPAP).

(4) Respiratory disease management devices.

(5) Hospital beds and commodes.

(6) Electronic and computer driven wheelchairs and seating systems.

(7) Apnea monitors.

(8) Low air loss continuous pressure management devices.

(9) Transcutaneous Electrical Nerve Stimulator (TENS) units.

(10) Prescription devices.

(11) Disposable medical supplies including, but not limited to, incontinence supplies as defined in Section 14125.1 of the Welfare and Institutions Code.

(12) In vitro diagnostic tests.

(13) Any other similar device as defined in regulations adopted by the department.

(c) The term “home medical device” does not include any of the following:

(1) Devices used or dispensed in the normal course of treating patients by hospitals and nursing facilities, other than devices delivered or dispensed by a separate unit or subsidiary corporation of a hospital or nursing facility or agency that is in the business of delivering home medical devices to an individual’s residence.

(2) Prosthetics and orthotics.

(3) Automated external defibrillators (AEDs).

(4) Devices provided through a physician’s office incident to a physician’s service.

(5) Devices provided by a licensed pharmacist that are used to administer drugs that can be dispensed only by a licensed pharmacist.

(6) Enteral and parenteral devices provided by a licensed pharmacist.

history: (History: Amended by Stats. 2001, Ch. 728, Sec. 70. Effective January 1, 2002.)


text: “Immediate container” does not include any package liner.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)


text: “Infant formula” shall have the same definition as that term is used in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 321(z)). The department shall review all changes to the federal definition of “infant formula” before those changes are incorporated by reference pursuant to this section. Within six months after the effective date of any changes to the federal definition, the department shall complete its review of the changes, and post a report on its Internet Web site that describes the changes and makes a recommendation as to whether it is appropriate to incorporate the changes by reference pursuant to this section. Any change to the federal definition shall take effect pursuant to this section one year after the effective date of the federal change, unless a law that specifically prohibits the change from taking effect is enacted and becomes effective.

history: (History: Amended by Stats. 2012, Ch. 728, Sec. 101. (SB 71) Effective January 1, 2013.)


text: “Label” means a display of written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its immediate container.


text: “Labeling” means any label or other written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its container or wrapper, or that accompanies any food, drug, device, or cosmetic.


text: “Local health department” means the health department of a city, county, city and county, or local health district that qualifies for state assistance pursuant to Chapter 3 (commencing with Section 101175) of Part 3 of Division 101, or any city health department of a city that has had its own health department for 12 years or more.


text: “Manufacture” means the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term “manufacture” includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic. The term “manufacture” does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer.


text: “Medical food” means any product that meets the definition of medical food in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360ee(b)(3)). The department shall review all changes to the federal definition of “medical food” before those changes are incorporated by reference pursuant to this section. Within six months after the effective date of any changes to the federal definition, the department shall complete its review of the changes, and submit a report to the Senate Health and Human Services Committee and the Assembly Health Committee that describes the changes and makes a recommendation as to whether it is appropriate to incorporate the changes by reference pursuant to this section. Any change to the federal definition shall take effect pursuant to this section one year after the effective date of the federal change, unless a law that specifically prohibits the change from taking effect is enacted and becomes effective.

history: (History: Amended by Stats. 2001, Ch. 641, Sec. 3. Effective January 1, 2002.)


text:
“New device” means any of the following:

(a) Any device the composition, construction, or properties of which are such that the device is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of devices, as having been adequately shown, through scientific investigations to be safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling or advertising thereof.

(b) Any device the composition, construction, or properties of which are such that the device, as a result of such investigation to determine its safety and effectiveness for use under these conditions, has become so recognized, but which has not, otherwise than in the investigations, been used to a material extent or for a material time under the conditions.


text:
“New drug” means either of the following:

(a) Any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling or advertising thereof.

(b) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under these conditions, has become so recognized, but that has not, otherwise than in the investigations, been used to a material extent or for a material time under the conditions.


text: “Official compendium” means the latest edition of the United States Pharmacopoeia, the latest edition of the Homeopathic Pharmacopoeia of the United States, or the latest edition of the National Formulary, or any supplement to any of these.


text:
“Package” means any container or wrapper that may be used by a manufacturer, producer, jobber, packer, or dealer for enclosing or containing any food, drug, device, or cosmetic.

The term “package” does not include any of the following:

(a) Any shipping container or outer wrapping used solely for the transportation of a food, drug, device, or cosmetic in bulk quantity to any manufacturer, packer, processor, or wholesale or retail distributor.

(b) Any shipping container or outer wrapping used by any retailer to ship or deliver any food, drug, device, or cosmetic to any retail consumer if the container or wrapping bears no printed matter pertaining to any food, drug, device, or cosmetic.


text: “Pasteurized in-shell eggs” means shell eggs that have been pasteurized by any method approved by the federal Food and Drug Administration, the Department of Food and Agriculture, or the department.

history: (History: Added by Stats. 2014, Ch. 11, Sec. 6. (AB 1414) Effective April 17, 2014.)


text: “Person” means any individual, firm, partnership, trust, corporation, limited liability company, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within the state, and any representative, agent, or agency of any of the foregoing.


text: “Pesticide chemical” means any substance that alone, in chemical combination, or in formulation with one or more substances, is an “economic poison” within the meaning of Section 12753 of the Food and Agricultural Code of this state or the Federal Insecticide, Fungicide, and Rodenticide Act (61 Stat. 163; 7 U.S.C. Sec. 135 et seq.), and that is used in the production, storage, or transportation of any raw agricultural commodity.


text: “Potentially hazardous food” means any food capable of supporting growth of infectious or toxigenic micro-organisms when held at temperatures above 45 degrees Fahrenheit.

history: (History: Amended by Stats. 1999, Ch. 915, Sec. 2. Effective January 1, 2000.)


text: “Prescription” means an oral order given individually for the patient for whom prescribed directly from the prescriber to the furnisher or indirectly by means of a written order signed by the prescriber that bears the name and address of the prescriber, the license classification of the prescriber, the name and address of the patient, the name and quantity of drug or device prescribed, the directions for use, and the date of issue.


text: “Prescription device” means any device limited to prescription use under Section 111470.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 30. Effective January 1, 2001.)


text: “Prescription drug” means any drug limited to prescription use under Section 111470.

history: (History: Added by Stats. 2000, Ch. 837, Sec. 31. Effective January 1, 2001.)


text: “Principal display panel” means that part of a label most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.


text: “Raw agricultural commodity” means any food in its raw or natural state. It includes, but is not limited to, any fruit that is washed, colored, or otherwise treated in its unpeeled natural form prior to marketing.


text:
(a) “Substantial evidence” means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug or device involved, on the basis that it could be fairly and responsibly concluded by the experts that the drug or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling, proposed labeling, or advertising of any drug or device.

(b) If the department determines, based on relevant science, that data from one adequate and well-controlled clinical investigation, and confirming evidence, obtained prior to or after the investigation, sufficiently establish effectiveness, then the department may consider that data and evidence, to constitute substantial evidence for purposes of the preceding sentence.

history: (History: Amended by Stats. 2000, Ch. 796, Sec. 3. Effective January 1, 2001.)


text:
The provisions of this part regarding the selling of any food, drug, device, or cosmetic include, but are not limited to, all of the following:

(a) The manufacture, production, processing, and packing of any food, drug, device, or cosmetic.

(b) The exhibition, offer, possession, or holding of any food, drug, device, or cosmetic for sale, dispensing, giving, supplying, or applying in the conduct of any establishment.

(c) The sale, dispensing, giving, supplying, or applying of any food, drug, device, or cosmetic in the conduct of any establishment.


text: All regulations pertaining to any food, drug, device, or cosmetic adopted by the department that are in effect on the effective date of this part shall remain in effect until the department adopts regulations pursuant to this part which repeal the regulations.


text: All laws and regulations pertaining to industrial hemp products shall remain in effect until the adoption of regulations pursuant to the federal law that authorizes industrial hemp products. At that time, the department shall adopt new regulations either as necessary pursuant to the federal law or deemed necessary to protect consumers.

history: (History: Added by Stats. 2021, Ch. 576, Sec. 4. (AB 45) Effective October 6, 2021.)


text: This part shall be so construed as to not be in conflict with the Food and Agricultural Code, or with the Alcoholic Beverage Control Act, Division 9 (commencing with Section 23000) of the Business and Professions Code, and the regulations adopted pursuant thereto.


text: The department shall administer and enforce this part.

chapter: 2. Administration

article: 1. General

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 2. Administration > 1. General


text: The Food Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under subdivision (c) of Section 110466 and Sections 110470, 110471, 110485, 114365, 114365.6, 111130, and 113717, and under Article 7 (commencing with Section 110810) of Chapter 5, or awarded to the department pursuant to court orders or settlements for the use of food safety-related activities, shall be deposited in the fund, for use by the department, upon appropriation by the Legislature, for the purposes of providing funds necessary to carry out and implement the inspection provisions of this part relating to food, licensing, inspection, enforcement, and other provisions of Article 12 (commencing with Section 111070) of Chapter 5, relating to water, the provisions relating to education and training in the prevention of microbial contamination pursuant to Section 110485, and the registration provisions of Article 7 (commencing with Section 110810) of Chapter 5, and to carry out and implement the provisions of the California Retail Food Code (Part 7 (commencing with Section 113700) of Division 104).

history: (History: Amended by Stats. 2015, Ch. 18, Sec. 13. (SB 75) Effective June 24, 2015.)

article: 1. General


text: All money collected by the department under Sections 111830, 111885, and 111905 shall be deposited into the State Treasury to the credit of the General Fund.

article: 1. General


text: The director and authorized agents of the department shall have the powers set forth in Sections 100165 and 106500.

article: 1. General


text:
For the purposes of administering this part, Part 6 (commencing with Section 111940) of Division 104 of the Health and Safety Code, Section 104559.5 of the Health and Safety Code, and Division 8.5 (commencing with Section 22950) of the Business and Professions Code, the following shall apply:

(a) The department shall submit to the Department of Justice fingerprints and related information required by the Department of Justice for all employees, prospective employees, contractors, or subcontractors whose duties include access to criminal offender record information, as defined in Section 11075 of the Penal Code, pursuant to subdivision (u) of Section 11105 of the Penal Code. The Department of Justice shall provide a state- or federal-level response pursuant to subdivision (p) of Section 11105 of the Penal Code.

(b) The department Food and Drug Branch Chief, or the designee of the Food and Drug Branch Chief that is a peace officer employee, shall review the criminal history of all persons listed in this section in order to make a final determination of a person’s fitness to perform duties.

history: (History: Added by Stats. 2024, Ch. 997, Sec. 16. (AB 179) Effective September 30, 2024.)

article: 1. General


text:
(a) The department may adopt any regulations that it determines are necessary for the enforcement of this part. The regulations shall be adopted by the department in the manner prescribed by Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. The department shall, insofar as practicable, make these regulations conform with those adopted under the federal act or by the United States Department of Agriculture or by the Internal Revenue Service of the United States Treasury Department.

(b) (1) The department may adopt emergency regulations to implement this division.

(2) The department may readopt any emergency regulation authorized by this section that is the same as, or substantially equivalent to, an emergency regulation previously adopted as authorized by this section. That readoption shall be limited to one time for each regulation.

(3) Notwithstanding any other law, the initial adoption of emergency regulations and the readoption of emergency regulations authorized by this section shall be deemed an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The initial emergency regulations and the readopted emergency regulations authorized by this section shall be each submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect for no more than 180 days, by which time final regulations shall be adopted.

(c) Initial regulations regarding industrial hemp shall be exempt from the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code), except that the department shall post the proposed regulations on its internet website for public comment for 30 days. The comments received shall be considered by the department and the final adopted regulations shall be filed with the Office of Administrative Law for publication in the California Code of Regulations. This exemption does not apply to regulations adopted pursuant to Section 111921.3 or 111922.

history: (History: Amended by Stats. 2021, Ch. 576, Sec. 5. (AB 45) Effective October 6, 2021.)

article: 1. General


text:
Whenever public health or other considerations in this state require, the department may adopt, upon its own motion, or upon the petition of any interested party, regulations that prescribe tolerances, included but not limited to zero tolerances, for poisonous or deleterious substances, food additives, pesticide chemicals, or color additives. The department may also prescribe the conditions under which a food additive or a color additive may be safely used and may grant exemptions for a food additive or color additive when it is to be used solely for investigational or experimental purposes.

A petitioner shall establish, by data submitted to the department, that a necessity exists for such regulations and that its effect will not be detrimental to the public health. If the data furnished by the petitioner is not sufficient to allow the department to determine whether such regulations should be adopted, the department may require additional data to be submitted. Failure to comply with this requirement shall be sufficient grounds to deny the request.

article: 1. General


text:
In adopting regulations, pursuant to Section 110070 of this part, the department shall consider all of the following factors that the petitioner shall furnish:

(a) The name and all pertinent information concerning the poisonous or deleterious substance, food additive, pesticide chemical, or color additive, including its chemical identity and composition, its proposed use, including directions, recommendations, and suggestions, its proposed labeling, and all other relevant data bearing on its physical or other technical effect, and the quantity required to produce that effect.

(b) The probable composition of any substance formed in or on a food, drug, device, or cosmetic resulting from the use of the substance.

(c) The probable consumption and effect of the substance in the diet of man or any other animal.

(d) Safety factors that, in the opinion of qualified experts, are generally recognized as appropriate for the use of animal experimentation data.

(e) Practicable methods of analysis for determining the identity and quantity of all of the following:

(1) Any substance which is in or on the food, drug, device, or cosmetic.

(2) Any substance formed in or on the food, drug, device, or cosmetic because of the use of the substance.

(3) The pure substance and its anticipated breakdown products and impurities.

(f) Facts supporting the contention that the use of the substance will serve a useful purpose.

article: 1. General


text:
(a) All pesticide regulations and any amendments to these regulations adopted pursuant to the federal act or the Food and Agricultural Code, in effect on November 23, 1970, or adopted on or after this date, are the pesticide regulations in this state. The department may, by regulation, prescribe tolerances for pesticides in processed foods in this state whether or not these tolerances are in accordance with the regulations adopted pursuant to the federal act or the Food and Agricultural Code.

(b) Except as otherwise provided in this subdivision, the department shall evaluate the tolerance prescribed, or an exemption from a tolerance granted, for a pesticide in processed foods and make a determination whether or not the existing tolerance, or the exemption from a tolerance, is protective of the public health whenever any one of the following occurs:

(1) The Director of Food and Agriculture designates the pesticide as a restricted material pursuant to subdivisions (a) and (b) of Section 14004.5 of the Food and Agricultural Code.

(2) The Director of Food and Agriculture refuses to register or cancels the registration of the pesticide pursuant to Section 12825, or suspends the registration of the pesticide pursuant to Section 12826, of the Food and Agricultural Code, upon determining that the pesticide is detrimental to the public health and safety.

(3) The Director of Food and Agriculture adopts regulations restricting worker entry into areas treated with the pesticide pursuant to Section 12981 of the Food and Agricultural Code.

(4) The pesticide is the subject of a proceeding pursuant to a determination by the Environmental Protection Agency under paragraph (3)(i)(A), (3)(ii)(A), (3)(ii)(B), or (3)(iii) of subsection (a) of Section 162.11 of Title 40 of the Code of Federal Regulations.

The requirement to evaluate a tolerance prescribed, or an exemption from a tolerance granted, for a pesticide does not apply if the department finds that any of the actions described in paragraphs (1) to (4), inclusive, occurred for reasons that are not related to the question whether or not the existing tolerance, or the exemption from a tolerance, adequately protects the public health. If the department makes such a finding, the reasons for the finding shall be stated in writing.

(c) The determination required by subdivision (b), and the reasons for the determination, shall be stated in writing. If the determination is required because any of the actions described in paragraphs (1) to (4), inclusive, of subdivision (b) occurs after January 1, 1985, the determination shall be completed within one year of the date of the action. If the determination is required because any of those actions occurred prior to January 1, 1985, the determination shall be completed by January 1, 1990.

(d) In any case where the department, after consultation with the Department of Food and Agriculture, determines, pursuant to subdivision (b), that the tolerance prescribed, or an exemption from a tolerance granted, for a pesticide is not protective of the public health, the department shall, if it does not act immediately pursuant to subdivision (a), transmit notice of its determination to the responsible federal agencies and shall request that they take action, pursuant to the federal act, to modify the tolerance or an exemption from a tolerance. If, after one year from the date the notice is transmitted, the department finds that the responsible federal agencies have failed to take appropriate action to protect the public health, the department shall exercise its authority pursuant to subdivision (a) to prescribe a tolerance that is protective of the public health and shall notify the responsible federal agencies of its action.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996. Note: See Section 26205 (from which this section is derived) as modified on July 17, 1991, in Governor's Reorganization Plan No. 1 of 1991.)

article: 1. General