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This entry was published on 2014-09-22
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SECTION 505
Animal irritancy tests prohibited
Public Health (PBH) CHAPTER 45, ARTICLE 5, TITLE 1
§ 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 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.