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AB-2059 Toxicological testing on dogs.(2019-2020)

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Date Published: 03/11/2020 09:00 PM
AB2059:v98#DOCUMENT

Amended  IN  Assembly  March 11, 2020

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Assembly Bill
No. 2059

Introduced by Assembly Member Kamlager
(Coauthor: Assembly Member Bloom)

February 04, 2020

An act to add Section 1834.9.3 to the Civil Code, relating to animal testing.


LEGISLATIVE COUNSEL'S DIGEST


AB 2059, as amended, Kamlager. Toxicological testing on dogs.
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 for 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.
This bill would prohibit a contract testing facility from conducting a canine toxicological experiment, defined as any test or study of any duration that seeks to determine the effect of the application or exposure of any amount of a chemical substance on a dog, unless the experiment is conducted for specified purposes, including medical research and or to comply with federal requirements pertaining to the approval or maintenance of a medical device. The bill would provide 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 civil penalty not to exceed $5,000 for each day that each dog is used in a canine toxicological experiment. The bill would define various terms for purposes of carrying out these provisions.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

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


SECTION 1.

 This measure shall be known, and may be cited, as the Protection of Dogs from Unnecessary Testing Act.

SEC. 2.

 Section 1834.9.3 is added to the Civil Code, immediately following Section 1834.9, to read:

1834.9.3.
 (a) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a contract testing facility shall not conduct a canine toxicological experiment in this state unless the experiment is conducted for any of the following purposes:
(1) Medical research.
(2) To comply with federal requirements pertaining to the approval or maintenance of a medical device, as defined under Section 321(h) of Title 21 of the United States Code.
(3) To achieve approval discovery, approval, or maintenance of a drug, as pursuant to a testing requirement imposed by the United States Food and Drug Administration (FDA) pursuant to under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C., U.S.C. Sec. 355 et seq.) seq. and 21 U.S.C. Sec. 360 et seq.) or Sec. 351 of the Public Health Service Act (42 U.S.C. Sec. 262 et seq.) or any binding agency regulation promulgated upon notice and comment thereunder, if the FDA has not otherwise expressly authorized drug manufacturers to use alternative test methods for the required test. methods.
(4) To achieve discovery, approval, or maintenance of a biologic, pursuant to a testing requirement imposed by the United States Department of Agriculture (USDA) under the Virus-Serum-Toxin Act (21 U.S.C. Sec. 151 et seq.) or any binding agency regulation promulgated upon notice and comment thereunder, if the USDA has not concluded that waivers shall be granted for the experimentation or studies or expressly indicated acceptance of alternative test methods.

(4)

(5) To achieve registration discovery, approval, registration, or maintenance of a pesticide, as pursuant to a testing requirement imposed by the United States Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, (7 U.S.C., Sec. 136 et seq.) or any binding agency regulation promulgated upon notice and comment thereunder, if the EPA has not concluded that waivers shall be granted for such experimentation or studies or expressly indicated acceptance of alternative test methods.

(5)

(6) To comply with a requirement to conduct the experiment under the Toxic Substances Control Act (15 U.S.C., Sec. 2601 et seq.), if the EPA has not, pursuant to Section 2603(h) of Title 15 of the United States Code, concluded that waivers shall be granted for such experimentation or studies or expressly indicated acceptance of testing methods alternative to laboratory animal testing, including, but not limited to, in vitro, in silico, and in chemico approaches for identifying skin sensitization hazards.
(b) For purposes of this section, the following terms have the following meanings:
(1) “Alternative test method” means a test method that does not use animals, or in some cases reduces or refines the use of animals, for which the reliability and relevance for a specific purpose has been established by validation bodies, including, but not limited to, the Inter-Agency Coordinating Committee for the Validation of Alternative Methods and the Organisation for Economic Co-operation and Development. Alternative test methods include, but are not limited to, high-throughput screening methods, testing of categories of chemical substances, tiered testing methods, in vitro studies, and systems biology.
(2) “Canine toxicological experiment” means any test or study of any duration that seeks to determine the effect, if any, of the application or exposure, whether internal or external, of any amount of a chemical substance on a dog. “Application or exposure” includes, but is not limited to, oral ingestion, skin or eye contact, or inhalation. “Application or exposure” does not include testing of veterinary products for canine health.
(3) “Chemical substance” means any organic or inorganic substance, including, but not limited to, a drug, as defined in Section 321(g) of Title 21 of the United States Code, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code.
(4) “Contract testing facility” means any partnership, corporation, association, or other legal relationship that tests chemicals, ingredients, product formulations, or products in this state.
(5) “Dog” means any member of the species Canis familiaris.
(6) “Medical research” means research related to the causes, progression, diagnosis, treatment, control, or prevention of physical or mental diseases and impairments or chronic conditions of humans and or animals or related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code. Medical research does not include research related to the development of drugs as defined in Section 321(g)(1) of Title 21 of the United States Code.
(c) Notwithstanding any 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, district attorney, or city attorney is the prevailing party in the enforcement action, the official may also recover costs, attorney fees, and a civil penalty not to exceed five thousand dollars ($5,000) for each day that each dog is used in a canine toxicological experiment in violation of this section.

SEC. 3.

 The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.