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| 1 | + | Amended IN Senate May 20, 2021 Amended IN Senate April 08, 2021 Amended IN Senate March 15, 2021 Amended IN Senate February 25, 2021 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Senate Bill No. 252Introduced by Senator Wiener(Coauthors: Assembly Members Bloom and Kalra)January 25, 2021 An act to add Section 1834.9.3 to the Civil Code, relating to animal testing.LEGISLATIVE COUNSEL'S DIGESTSB 252, as amended, Wiener. Toxicological testing on dogs and cats.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 exempts 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 testing facility, as defined, from conducting a canine or feline 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 or cat, as defined, unless the experiment is conducted for specified purposes, including medical research, as defined, or described, to comply with federal requirements pertaining to the approval or maintenance of a medical device. device, or to develop, manufacture, or market certain types of products. The bill would authorize the Attorney General, the district attorney of the county in which the violation is alleged to have occurred, or the city attorney in certain instances to bring a civil action for a violation of these provisions, punishable by a civil penalty not to exceed $5,000 for each day that each dog or cat is used in a canine or feline toxicological experiment.The bill would define various terms for purposes of carrying out these provisions.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe 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 and Cats 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 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research. research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, pursuant to a testing requirement imposed when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, pursuant to a testing requirement imposed by the United States Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, Act (7 U.S.C., 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.(6) To comply with a requirement to conduct the experiment under the Toxic Substances Control Act (15 U.S.C., 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)Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3)Canine or feline 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 or cat. 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 or feline health.(4)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.(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 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. The term 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, except that the term medical research shall include research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code.(7)Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, subdivision (a) shall not apply to testing or experimentation conducted for the purpose of developing, manufacturing, or marketing any for either of the following types of products:(1) Any product intended solely for use in nonhuman animals, including, but not limited to, animal vaccines, animal medicine, or flea and tick products intended to be applied only to nonhuman animals.(2) Any product that is intended for use in an indication where similar products are routinely used or contemplated to be used in both human and nonhuman animal medicine where the product is or is contemplated to be substantially the same formulation for both nonhuman animal and human markets.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. | |
| 2 | 2 | ||
| 3 | - | ||
| 3 | + | Amended IN Senate May 20, 2021 Amended IN Senate April 08, 2021 Amended IN Senate March 15, 2021 Amended IN Senate February 25, 2021 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Senate Bill No. 252Introduced by Senator Wiener(Coauthors: Assembly Members Bloom and Kalra)January 25, 2021 An act to add Section 1834.9.3 to the Civil Code, relating to animal testing.LEGISLATIVE COUNSEL'S DIGESTSB 252, as amended, Wiener. Toxicological testing on dogs and cats.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 exempts 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 testing facility, as defined, from conducting a canine or feline 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 or cat, as defined, unless the experiment is conducted for specified purposes, including medical research, as defined, or described, to comply with federal requirements pertaining to the approval or maintenance of a medical device. device, or to develop, manufacture, or market certain types of products. The bill would authorize the Attorney General, the district attorney of the county in which the violation is alleged to have occurred, or the city attorney in certain instances to bring a civil action for a violation of these provisions, punishable by a civil penalty not to exceed $5,000 for each day that each dog or cat is used in a canine or feline toxicological experiment.The bill would define various terms for purposes of carrying out these provisions.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO | |
| 4 | 4 | ||
| 5 | - | ||
| 5 | + | Amended IN Senate May 20, 2021 Amended IN Senate April 08, 2021 Amended IN Senate March 15, 2021 Amended IN Senate February 25, 2021 | |
| 6 | 6 | ||
| 7 | - | Amended IN Assembly June 21, 2021 | |
| 8 | 7 | Amended IN Senate May 20, 2021 | |
| 9 | 8 | Amended IN Senate April 08, 2021 | |
| 10 | 9 | Amended IN Senate March 15, 2021 | |
| 11 | 10 | Amended IN Senate February 25, 2021 | |
| 12 | 11 | ||
| 13 | 12 | CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION | |
| 14 | 13 | ||
| 15 | 14 | Senate Bill | |
| 16 | 15 | ||
| 17 | 16 | No. 252 | |
| 18 | 17 | ||
| 19 | - | Introduced by Senator Wiener | |
| 18 | + | Introduced by Senator Wiener(Coauthors: Assembly Members Bloom and Kalra)January 25, 2021 | |
| 20 | 19 | ||
| 21 | - | Introduced by Senator Wiener | |
| 20 | + | Introduced by Senator Wiener(Coauthors: Assembly Members Bloom and Kalra) | |
| 22 | 21 | January 25, 2021 | |
| 23 | 22 | ||
| 24 | 23 | An act to add Section 1834.9.3 to the Civil Code, relating to animal testing. | |
| 25 | 24 | ||
| 26 | 25 | LEGISLATIVE COUNSEL'S DIGEST | |
| 27 | 26 | ||
| 28 | 27 | ## LEGISLATIVE COUNSEL'S DIGEST | |
| 29 | 28 | ||
| 30 | 29 | SB 252, as amended, Wiener. Toxicological testing on dogs and cats. | |
| 31 | 30 | ||
| 32 | - | 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 exempts 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 testing facility, as defined, from conducting a canine or feline toxicological experiment, as defined, unless the experiment is conducted for specified purposes, including medical research, as described, to comply with federal requirements pertaining to the approval or maintenance of a medical device, or to develop, manufacture, or market certain types of products. The bill would authorize the Attorney General, the district attorney of the county in which the violation is alleged to have occurred, or the city attorney in certain instances to bring a civil action for a violation of these provisions, punishable by a civil penalty not to exceed $5,000 for each day that each dog or cat is used in a canine or feline toxicological experiment.The bill would define various terms for purposes of carrying out these provisions. | |
| 31 | + | 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 exempts 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 testing facility, as defined, from conducting a canine or feline 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 or cat, as defined, unless the experiment is conducted for specified purposes, including medical research, as defined, or described, to comply with federal requirements pertaining to the approval or maintenance of a medical device. device, or to develop, manufacture, or market certain types of products. The bill would authorize the Attorney General, the district attorney of the county in which the violation is alleged to have occurred, or the city attorney in certain instances to bring a civil action for a violation of these provisions, punishable by a civil penalty not to exceed $5,000 for each day that each dog or cat is used in a canine or feline toxicological experiment.The bill would define various terms for purposes of carrying out these provisions. | |
| 33 | 32 | ||
| 34 | 33 | 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 exempts 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. | |
| 35 | 34 | ||
| 36 | - | This bill would prohibit a testing facility, as defined, from conducting a canine or feline toxicological experiment, as defined, unless the experiment is conducted for specified purposes, including medical research, as described, to comply with federal requirements pertaining to the approval or maintenance of a medical device, or to develop, manufacture, or market certain types of products. The bill would authorize the Attorney General, the district attorney of the county in which the violation is alleged to have occurred, or the city attorney in certain instances to bring a civil action for a violation of these provisions, punishable by a civil penalty not to exceed $5,000 for each day that each dog or cat is used in a canine or feline toxicological experiment. | |
| 35 | + | This bill would prohibit a testing facility, as defined, from conducting a canine or feline 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 or cat, as defined, unless the experiment is conducted for specified purposes, including medical research, as defined, or described, to comply with federal requirements pertaining to the approval or maintenance of a medical device. device, or to develop, manufacture, or market certain types of products. The bill would authorize the Attorney General, the district attorney of the county in which the violation is alleged to have occurred, or the city attorney in certain instances to bring a civil action for a violation of these provisions, punishable by a civil penalty not to exceed $5,000 for each day that each dog or cat is used in a canine or feline toxicological experiment. | |
| 37 | 36 | ||
| 38 | 37 | The bill would define various terms for purposes of carrying out these provisions. | |
| 39 | 38 | ||
| 40 | 39 | ## Digest Key | |
| 41 | 40 | ||
| 42 | 41 | ## Bill Text | |
| 43 | 42 | ||
| 44 | - | 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 and Cats 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) 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, 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.(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.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, | |
| 43 | + | 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 and Cats 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 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research. research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, pursuant to a testing requirement imposed when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, pursuant to a testing requirement imposed by the United States Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, Act (7 U.S.C., 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.(6) To comply with a requirement to conduct the experiment under the Toxic Substances Control Act (15 U.S.C., 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)Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3)Canine or feline 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 or cat. 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 or feline health.(4)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.(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 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. The term 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, except that the term medical research shall include research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code.(7)Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, subdivision (a) shall not apply to testing or experimentation conducted for the purpose of developing, manufacturing, or marketing any for either of the following types of products:(1) Any product intended solely for use in nonhuman animals, including, but not limited to, animal vaccines, animal medicine, or flea and tick products intended to be applied only to nonhuman animals.(2) Any product that is intended for use in an indication where similar products are routinely used or contemplated to be used in both human and nonhuman animal medicine where the product is or is contemplated to be substantially the same formulation for both nonhuman animal and human markets.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. | |
| 45 | 44 | ||
| 46 | 45 | The people of the State of California do enact as follows: | |
| 47 | 46 | ||
| 48 | 47 | ## The people of the State of California do enact as follows: | |
| 49 | 48 | ||
| 50 | 49 | SECTION 1. This measure shall be known, and may be cited, as the Protection of Dogs and Cats from Unnecessary Testing Act. | |
| 51 | 50 | ||
| 52 | 51 | SECTION 1. This measure shall be known, and may be cited, as the Protection of Dogs and Cats from Unnecessary Testing Act. | |
| 53 | 52 | ||
| 54 | 53 | SECTION 1. This measure shall be known, and may be cited, as the Protection of Dogs and Cats from Unnecessary Testing Act. | |
| 55 | 54 | ||
| 56 | 55 | ### SECTION 1. | |
| 57 | 56 | ||
| 58 | - | SEC. 2. Section 1834.9.3 is added to the Civil Code, immediately following Section 1834.9, to read:1834.9.3. (a) 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, 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.(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.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, | |
| 57 | + | SEC. 2. Section 1834.9.3 is added to the Civil Code, immediately following Section 1834.9, to read:1834.9.3. (a) Notwithstanding 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research. research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, pursuant to a testing requirement imposed when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, pursuant to a testing requirement imposed by the United States Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, Act (7 U.S.C., 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.(6) To comply with a requirement to conduct the experiment under the Toxic Substances Control Act (15 U.S.C., 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)Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3)Canine or feline 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 or cat. 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 or feline health.(4)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.(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 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. The term 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, except that the term medical research shall include research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code.(7)Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, subdivision (a) shall not apply to testing or experimentation conducted for the purpose of developing, manufacturing, or marketing any for either of the following types of products:(1) Any product intended solely for use in nonhuman animals, including, but not limited to, animal vaccines, animal medicine, or flea and tick products intended to be applied only to nonhuman animals.(2) Any product that is intended for use in an indication where similar products are routinely used or contemplated to be used in both human and nonhuman animal medicine where the product is or is contemplated to be substantially the same formulation for both nonhuman animal and human markets. | |
| 59 | 58 | ||
| 60 | 59 | SEC. 2. Section 1834.9.3 is added to the Civil Code, immediately following Section 1834.9, to read: | |
| 61 | 60 | ||
| 62 | 61 | ### SEC. 2. | |
| 63 | 62 | ||
| 64 | - | 1834.9.3. (a) 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, 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.(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.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, | |
| 63 | + | 1834.9.3. (a) Notwithstanding 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research. research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, pursuant to a testing requirement imposed when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, pursuant to a testing requirement imposed by the United States Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, Act (7 U.S.C., 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.(6) To comply with a requirement to conduct the experiment under the Toxic Substances Control Act (15 U.S.C., 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)Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3)Canine or feline 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 or cat. 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 or feline health.(4)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.(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 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. The term 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, except that the term medical research shall include research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code.(7)Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, subdivision (a) shall not apply to testing or experimentation conducted for the purpose of developing, manufacturing, or marketing any for either of the following types of products:(1) Any product intended solely for use in nonhuman animals, including, but not limited to, animal vaccines, animal medicine, or flea and tick products intended to be applied only to nonhuman animals.(2) Any product that is intended for use in an indication where similar products are routinely used or contemplated to be used in both human and nonhuman animal medicine where the product is or is contemplated to be substantially the same formulation for both nonhuman animal and human markets. | |
| 65 | 64 | ||
| 66 | - | 1834.9.3. (a) 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, 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.(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.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, | |
| 65 | + | 1834.9.3. (a) Notwithstanding 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research. research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, pursuant to a testing requirement imposed when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, pursuant to a testing requirement imposed by the United States Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, Act (7 U.S.C., 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.(6) To comply with a requirement to conduct the experiment under the Toxic Substances Control Act (15 U.S.C., 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)Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3)Canine or feline 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 or cat. 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 or feline health.(4)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.(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 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. The term 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, except that the term medical research shall include research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code.(7)Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, subdivision (a) shall not apply to testing or experimentation conducted for the purpose of developing, manufacturing, or marketing any for either of the following types of products:(1) Any product intended solely for use in nonhuman animals, including, but not limited to, animal vaccines, animal medicine, or flea and tick products intended to be applied only to nonhuman animals.(2) Any product that is intended for use in an indication where similar products are routinely used or contemplated to be used in both human and nonhuman animal medicine where the product is or is contemplated to be substantially the same formulation for both nonhuman animal and human markets. | |
| 67 | 66 | ||
| 68 | - | 1834.9.3. (a) 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, 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.(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.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, | |
| 67 | + | 1834.9.3. (a) Notwithstanding 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 Interagency 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) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3) Canine or feline 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 or cat. 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 or feline health.(4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021.(5) Dog means any member of the species Canis familiaris.(6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes:(1) Medical research. research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3).(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 discovery, approval, or maintenance of a drug, pursuant to a testing requirement imposed when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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.(4) To achieve discovery, approval, registration, licensing, 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.(5) To achieve discovery, approval, registration, or maintenance of a pesticide, pursuant to a testing requirement imposed by the United States Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, Act (7 U.S.C., 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.(6) To comply with a requirement to conduct the experiment under the Toxic Substances Control Act (15 U.S.C., 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)Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora.(3)Canine or feline 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 or cat. 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 or feline health.(4)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.(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 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. The term 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, except that the term medical research shall include research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code.(7)Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state.(c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section.(2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section.(d) Notwithstanding any other provision in this section, subdivision (a) shall not apply to testing or experimentation conducted for the purpose of developing, manufacturing, or marketing any for either of the following types of products:(1) Any product intended solely for use in nonhuman animals, including, but not limited to, animal vaccines, animal medicine, or flea and tick products intended to be applied only to nonhuman animals.(2) Any product that is intended for use in an indication where similar products are routinely used or contemplated to be used in both human and nonhuman animal medicine where the product is or is contemplated to be substantially the same formulation for both nonhuman animal and human markets. | |
| 69 | 68 | ||
| 70 | 69 | ||
| 71 | 70 | ||
| 72 | - | 1834.9.3. (a) For purposes of this section, the following terms have the following meanings: | |
| 71 | + | 1834.9.3. (a) Notwithstanding For purposes of this section, the following terms have the following meanings: | |
| 73 | 72 | ||
| 74 | 73 | (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 Interagency 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. | |
| 75 | 74 | ||
| 76 | 75 | (2) Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora. | |
| 77 | 76 | ||
| 78 | 77 | (3) Canine or feline 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 or cat. 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 or feline health. | |
| 79 | 78 | ||
| 80 | 79 | (4) 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 as that section read on January 1, 2021, a pesticide, as defined in Section 136(u) of Title 7 of the United States Code as that section read on January 1, 2021, a chemical substance, as defined in Section 2602(2) of Title 15 of the United States Code as that section read on January 1, 2021, or a food additive, as defined in Section 321(s) of Title 21 of the United States Code as that section read on January 1, 2021. | |
| 81 | 80 | ||
| 82 | 81 | (5) Dog means any member of the species Canis familiaris. | |
| 83 | 82 | ||
| 84 | 83 | (6) Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state. | |
| 85 | 84 | ||
| 86 | 85 | (b) Notwithstanding any law, and in addition to the prohibitions set forth in Sections 1834.9 and 1834.9.5, a testing facility shall not conduct a canine or feline toxicological experiment in this state unless the experiment is conducted for any of the following purposes: | |
| 87 | 86 | ||
| 88 | - | (1) Medical research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3). | |
| 87 | + | (1) Medical research. research, including research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code as that section read on January 1, 2021, and research related to the development of biomedical products or devices, as defined under Section 321(h) of Title 21 of the United States Code as that section read on January 1, 2021. Medical research related to the development of drugs, as defined in Section 321(g)(1) of Title 21 of the United States Code as that section read on January 1, 2021, is not subject to this exemption unless it meets the requirements outlined in paragraph (3). | |
| 89 | 88 | ||
| 90 | 89 | (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. | |
| 91 | 90 | ||
| 92 | - | (3) To achieve discovery, approval, or maintenance of a drug, when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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. | |
| 91 | + | (3) To achieve discovery, approval, or maintenance of a drug, pursuant to a testing requirement imposed when required by federal law or directed by writing by the United States Food and Drug Administration (FDA) under Section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355 et 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. | |
| 93 | 92 | ||
| 94 | 93 | (4) To achieve discovery, approval, registration, licensing, 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. | |
| 95 | 94 | ||
| 96 | - | (5) To achieve discovery, approval, registration, or maintenance of a pesticide, 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. | |
| 95 | + | (5) To achieve discovery, approval, registration, or maintenance of a pesticide, pursuant to a testing requirement imposed by the United States Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, Act (7 U.S.C., 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. | |
| 97 | 96 | ||
| 98 | - | (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. | |
| 97 | + | (6) To comply with a requirement to conduct the experiment under the Toxic Substances Control Act (15 U.S.C., 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. | |
| 98 | + | ||
| 99 | + | (b)For purposes of this section, the following terms have the following meanings: | |
| 100 | + | ||
| 101 | + | ||
| 102 | + | ||
| 103 | + | (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. | |
| 104 | + | ||
| 105 | + | ||
| 106 | + | ||
| 107 | + | (2)Cat means a small domesticated carnivorous mammal that is a member of the family Felidae, order Carnivora. | |
| 108 | + | ||
| 109 | + | ||
| 110 | + | ||
| 111 | + | (3)Canine or feline 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 or cat. 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 or feline health. | |
| 112 | + | ||
| 113 | + | ||
| 114 | + | ||
| 115 | + | (4)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. | |
| 116 | + | ||
| 117 | + | ||
| 118 | + | ||
| 119 | + | (5)Dog means any member of the species Canis familiaris. | |
| 120 | + | ||
| 121 | + | ||
| 122 | + | ||
| 123 | + | (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 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. The term 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, except that the term medical research shall include research related to the development of any vaccine, as defined under Section 4132(a)(2) of Title 26 of the United States Code. | |
| 124 | + | ||
| 125 | + | ||
| 126 | + | ||
| 127 | + | (7)Testing facility means any partnership, corporation, association, school, institution, organization, or other legal relationship, whether privately or government owned, leased, or operated, that tests chemicals, ingredients, product formulations, or products in this state. | |
| 128 | + | ||
| 129 | + | ||
| 99 | 130 | ||
| 100 | 131 | (c) (1) Notwithstanding any other law, 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 city and county having a population in excess of 750,000 and in which the violation is alleged to have occurred, may bring a civil action for injunctive relief pursuant to this paragraph. 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 or each cat is used in a canine or feline toxicological experiment in violation of this section. | |
| 101 | 132 | ||
| 102 | 133 | (2) The procedure set forth in paragraph (1) is the exclusive remedy for enforcing this section. | |
| 103 | 134 | ||
| 104 | - | (d) Notwithstanding any other provision in this section, | |
| 135 | + | (d) Notwithstanding any other provision in this section, subdivision (a) shall not apply to testing or experimentation conducted for the purpose of developing, manufacturing, or marketing any for either of the following types of products: | |
| 105 | 136 | ||
| 106 | 137 | (1) Any product intended solely for use in nonhuman animals, including, but not limited to, animal vaccines, animal medicine, or flea and tick products intended to be applied only to nonhuman animals. | |
| 107 | 138 | ||
| 108 | - | ||
| 109 | - | ||
| 110 | 139 | (2) Any product that is intended for use in an indication where similar products are routinely used or contemplated to be used in both human and nonhuman animal medicine where the product is or is contemplated to be substantially the same formulation for both nonhuman animal and human markets. | |
| 111 | - | ||
| 112 | - | ||
| 113 | 140 | ||
| 114 | 141 | 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. | |
| 115 | 142 | ||
| 116 | 143 | 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. | |
| 117 | 144 | ||
| 118 | 145 | 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. | |
| 119 | 146 | ||
| 120 | 147 | ### SEC. 3. |