Amended  IN  Assembly  May 25, 2023
Amended  IN  Assembly  March 15, 2023
Amended  IN  Assembly  March 07, 2023

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Assembly Bill
No. 357

Introduced by Assembly Member Maienschein

February 01, 2023

An act to amend Section 1834.9 of the Civil Code, relating to animal testing.


LEGISLATIVE COUNSEL'S DIGEST


AB 357, as amended, Maienschein. Animal test methods: alternatives.
Existing law prohibits manufacturers and contract testing facilities from using traditional animal test methods within the state for which an appropriate alternative test method has been scientifically validated and recommended by the Inter-Agency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and adopted, as specified. Existing law excepts certain animal tests from these provisions, including animal tests performed for the purpose of medical research. Existing law provides that the exclusive remedy for a violation of these provisions is a civil action for injunctive relief brought by, among others, the Attorney General and makes a violation of these provisions punishable by a specified civil penalty. Existing law defines various terms for purposes of these provisions.
This bill would instead prohibit manufacturers and contract testing facilities from using traditional animal test methods, as defined, within this state for which an appropriate alternative test method or strategy exists, or a waiver has been granted by the agency responsible for regulating the specific product or activity for which the test is being conducted. If an appropriate alternative test method or strategy is unavailable, the bill would require a testing facility to use a traditional animal test method pursuant to prescribed standards, including using the fewest number of animals possible. The bill would define alternative test method or strategy as a test method that does not use animals, provides information of equivalent or better scientific quality and relevance compared to traditional animal test methods, and has been identified and accepted for use by a federal agency or program, as specified. The bill would except from these provisions traditional animal tests performed for the purpose of biomedical medical research, as defined to not include testing done to assess the safety or efficacy of chemicals, ingredients, drugs, medical devices, vaccines, product formulations, or products, defined, and make conforming changes.
The bill would also, starting January 1, 2025, and annually thereafter, require a manufacturer or contract testing facility that uses traditional animal test methods to report specified information to the Attorney General, State Department of Public Health, and would require the Attorney General department to make that information publicly available on its internet website. The bill would require the department to ensure that information made available to the public does not include personally identifiable information or proprietary information.
Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.
This bill would make legislative findings to that effect.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Section 1834.9 of the Civil Code is amended to read:

1834.9.
 (a) Manufacturers and contract testing facilities shall not use traditional animal test methods within this state for which an appropriate alternative test method or strategy exists, or a waiver has been granted by the agency responsible for regulating the specific product or activity for which the test is being conducted. When there is no appropriate alternative test method or strategy available, manufacturers and contract testing facilities shall use a traditional animal test method using the fewest number of animals possible and reducing the level of pain, suffering, and stress of an animal used for testing to the greatest extent possible. testing.
(b) This section does not prohibit the use of any nonanimal test method or strategy for the testing of any product, product formulation, chemical, drug, medical device, vaccine, or ingredient that is not described in paragraph (1) of subdivision (g).
(c) (1) This section does not prohibit the use of traditional animal test methods to comply with requirements of state or federal agencies.
(2) This section does not prohibit the use of traditional animal test methods to comply with requests from state or federal agencies when the agency has approved an alternative nonanimal test method or strategy pursuant to subdivision (a), but concludes that a traditional animal test method is needed to fully assess the impacts on the health or safety of consumers.
(d) Notwithstanding any other law, the exclusive remedy for enforcing this section shall be a civil action for injunctive relief brought by the Attorney General, the district attorney of the county in which the violation is alleged to have occurred, or a city attorney of a city or a city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred. If the court determines that the Attorney General or district attorney is the prevailing party in the enforcement action, the official may also recover costs, attorney’s fees, and a civil penalty not to exceed five thousand dollars ($5,000) in that action.
(e) This section shall not apply to any traditional animal test methods performed for the purpose of biomedical medical research.
(f) (1) Starting January 1, 2025, and annually thereafter, a manufacturer or contract testing facility in this state using traditional animal test methods shall report to the Attorney General methods, except for those traditional animal test methods exempt under subdivision (e), shall report to the department the number and species of animals used, the type and number of alternative test methods or strategies used, the number of waivers used, and the purpose of the use of the traditional animal tests, alternative test methods or strategies, and waivers. The Attorney General shall make the results of this data collection publicly available on its internet website. The Attorney General shall ensure that information made available to the public does not include personally identifiable information or proprietary information.
(2) The department shall develop and maintain a portal on its internet website to receive the information required by paragraph (1) and make the information collected publicly available on its internet website. The department shall ensure that information made available to the public does not include personally identifiable information or proprietary information.
(g) For the purposes of this section, the following terms apply:
(1) “Alternative test method or strategy” means a test method, including a new or revised method, that fulfills all of the following criteria:
(A) Does not use animals.
(B) Provides information of equivalent or better scientific quality and relevance compared to traditional animal test methods, and includes, but is not limited to, computational toxicology and bioinformatics, high-throughput screening methods, testing of categories of chemical substances, tiered testing methods, in vitro studies, and systems biology.
(C) Has been identified and accepted for use by a federal agency or program within an agency responsible for regulating the specific product or activity for which the test is being conducted.
(2) “Animal” means vertebrate nonhuman animal.

(3)“Biomedical research” means the investigation of the biological processes and causes of disease or research conducted to increase fundamental scientific knowledge, and to expand the understanding about how processes in living organisms develop and function, but shall not include traditional animal test methods done to assess the safety or efficacy of chemicals, ingredients, drugs, medical devices, vaccines, product formulations, or products.

(4)

(3) “Contract testing facility” means any partnership, corporation, association, or other legal relationship that tests chemicals, ingredients, drugs, medical devices, vaccines, product formulations, or products in this state.
(4) “Department” means the State Department of Public Health.
(5) “Manufacturer” means any partnership, corporation, association, or other legal relationship that produces chemicals, ingredients, drugs, medical devices, vaccines, product formulations, or products in this state.
(6) “Medical research” means research related to the causes, diagnosis, treatment, control, or prevention of physical or mental diseases and impairments of humans and animals or related to the development of biomedical products, devices, or drugs as defined in Section 321(g)(1) of Title 21 of the United States Code. Medical research does not include the testing of an ingredient that was formerly used in a drug, tested for the drug use with traditional animal methods to characterize the ingredient and to substantiate its safety for human use, and is now proposed for use in a product other than a biomedical product, medical device, or drug.

(6)

(7) “Person” means an individual with managerial control, or a partnership, corporation, association, or other legal relationship.

(7)

(8) “Traditional animal test method” means a process or procedure using animals to obtain information on the characteristics of a chemical or agent and that generates information regarding the ability of a chemical or agent to produce a specific biological effect under specified conditions.

SEC. 2.

 The Legislature finds and declares that Section 1 of this act, which amends Section 1834.9 of the Civil Code, imposes a limitation on the public’s right of access to the meetings of public bodies or the writings of public officials and agencies within the meaning of Section 3 of Article I of the California Constitution. Pursuant to that constitutional provision, the Legislature makes the following findings to demonstrate the interest protected by this limitation and the need for protecting that interest:
The act protects the personal and proprietary information retained by the State Department of Public Health from public disclosure.