New York Consolidated Laws, Public Health Law - PBH § 505. Animal irritancy tests prohibited

1. No manufacturer or contract testing facilities shall conduct traditional animal test methods within this 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 by the regulation by the relevant federal agency or agencies or program within an agency responsible for regulating the specific product or activity for which the test is being conducted.

2. Nothing in this section shall prohibit the conduct of any alternative nonanimal test method for the testing of any product, product formulation, chemical, or ingredient that is not recommended by ICCVAM.

3. Nothing in this section shall prohibit the conduct of animal tests to comply with the requirements of state agencies.  Nothing in this section shall prohibit the conduct of animal tests to comply with the requirements of federal agencies whenever the federal agency staff concludes that the alternative nonanimal test does not assure the health or safety of consumers.

4. Notwithstanding any other provision of law, the exclusive remedy for enforcing this section shall be a civil action for injunctive relief brought by the attorney general.  If the court determines that the attorney general is the prevailing party in the enforcement action, such prevailing party may also recover costs, attorneys fees and a civil penalty not to exceed one thousand dollars in that action.

5. This section shall not apply to any animal test conducted for the purpose of medical research.

6. For the purposes of this section, the following terms shall have the following meanings:

(a) “Animal” means a vertebrate nonhuman animal.

(b) “Contract testing facility” means any individual, partnership, corporation, association, or other legal relationship that tests chemicals, ingredients, product formulations, or products in this state.

(c) “ICCVAM” means the Inter-Agency Coordinating Committee for the Validation of Alternative Methods, a federal committee comprised of representatives from fourteen federal regulatory or research agencies, including the Food and Drug Administration, Environmental Protection Agency, and Consumer Products Safety Commission, that reviews the validity of alternative test methods.  The committee is the federal mechanism for recommending appropriate, valid test methods to relevant federal agencies.

(d) “Manufacturer” means any individual, partnership, corporation, association, or other legal relationship that produces chemicals, ingredients, product formulations, or products in this state.

(e) “Medical research” means research related to the causes, diagnosis, treatment, control or prevention of physical or mental diseases and impairments of humans and animals, or related to the development of biomedical products, devices or drugs as defined in Section 321(g)(1) of Title 21 of the United States Code .  Medical research does not include the testing of an ingredient that was formerly used in a drug, tested for the drug use with traditional animal methods to characterize the ingredient and to substantiate its safety for human use, and is now proposed for use in a product other than a biomedical product, medical device or drug.

(f) “Person” means any individual, partnership, corporation, association or other legal entity.

(g) “Traditional animal test method” means a process or procedure using animals to obtain information on the characteristics of a chemical or agent.  Toxicological test methods generate information regarding the ability of a chemical or agent to product   1 a specific biological effect under specified conditions.

(h) “Validated alternative test method” means a test method that does not use animals, or in some cases reduces or refines the current use of animals for which the reliability and relevance for a specific purpose has been established in validation studies as specified in the ICCVAM report provided to the relevant federal agencies.

1 So in original (“product” should be “produce”).

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