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.