Mckinney’s Consolidated Laws of New York Annotated. Public Health Law. Chapter 45. Of the Consolidated Laws. Article 5. Laboratories. Title I. General Provisions: State Laboratories; Approved Laboratories.
Primary Citation: McKinney’s Public Health Law § 500 – 506
Alternate Citation: NY PUB HEALTH § 500 – 506
Summary: The group of statutes provides that the commissioner shall require laboratories and research facilities to treat all animals used in testing humanely, provide food and suitable housing, and that any experiments that inflict or involve pain shall be performed with anesthesia. Each research facility shall be inspected by the commissioner in order to ensure compliance with said rules. In addition, the statutes provide that alternative animal testing methods be utilized when the alternative has been scientifically validated and recommended by the Inter-Agency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) and adopted by the appropriate federal agency.
The People of the State of New York, represented in Senate and Assembly, do enact as follows: Section 1. The general business law is amended by adding a new section 399-aaaaa to read as follows:
§ 399-aaaaa. Selling of animal tested cosmetics.
1. For the purposes of this section the following terms shall have the following meanings: (a) “Cosmetic” shall mean articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, including but not limited to personal hygiene products such as deodorant, shampoo or conditioner. (b) “Animal testing” shall mean the internal or external application of a cosmetic, either in its final form or any ingredient thereof, to the skin, eyes, or other body part of a live non-human vertebrate. (c) “Ingredient” shall have the same meaning as defined in 21 CFR 700.3(e). (d) “Manufacturer” shall mean any person whose name appears on the label of a cosmetic pursuant to the requirements of 21 CFR 701.12. (e) “Supplier” shall mean any entity that supplies, directly or through a third party, any ingredient used by a manufacturer in the formulation of a cosmetic.
2. Except as otherwise provided in this section, it shall be unlawful for a manufacturer to import for profit, sell or offer for sale in the state, any cosmetic which the manufacturer knew or reasonably should have known that animal testing was conducted or contracted by or on behalf of the manufacturer or any supplier of the manufacturer if the animal testing was conducted after the effective date of this section.
3. This section does not apply to animal testing that is conducted: (a) As a requirement of any federal or state regulatory agency if: (i) the cosmetic or an ingredient in the cosmetic which is being tested is in wide use and cannot be replaced by another ingredient which is capable of performing a similar function; and (ii) a specific human health problem relating to the cosmetic or ingredient is substantiated and the need to conduct animal testing is justified and supported by a detailed protocol for research that is proposed as the basis for the evaluation of the cosmetic or ingredient; and (iii) there does not exist a method of testing other than animal testing that is accepted for the relevant purpose by a federal or state regulatory agency. (b) As a requirement of any regulatory agency of a foreign jurisdiction, if no evidence derived from such testing was relied upon to substantiate the safety of a cosmetic sold within the state by the manufacturer. (c) For any product or ingredient in a cosmetic which is subject to the requirements under 21 USC subchapter V. (d) For purposes not related to cosmetics as required by any federal, state or foreign regulatory agency, provided that no evidence derived from such testing was relied upon to substantiate the safety of a cosmetic sold within the state by the manufacturer, unless: (i) documentary evidence exists that the intent of the animal testing was unrelated to cosmetics; and (ii) there is a history of the use of the ingredient unrelated to cosmetics for a minimum of twelve months.
4. This section does not apply to a cosmetic: (a) If in its final form, such cosmetic was tested on animals before the effective date of this section, even if the cosmetic is manufactured on or after such date. (b) If an ingredient contained in such cosmetic was tested on animals and sold in New York state before the effective date of this section, even if such ingredient is manufactured on or after such date.
5. This section may not be construed to prevent a manufacturer from reviewing, assessing or retaining data resulting from animal testing.
6. The attorney general may upon a determination that there is a reasonable likelihood of a violation of this section, review any testing data on which a manufacturer has relied in determining the safety of a cosmetic or an ingredient in a cosmetic sold in the state. Any information disclosed under this section shall be protected as a trade secret and the attorney general shall enter into a protective order with the manufacturer before receipt of such information from the manufacturer. The attorney general shall take other appropriate measures as necessary to preserve the confidentiality of the information produced pursuant to this section. The attorney general may bring an action or special proceeding in the supreme court for a judgment enjoining the continuance of such violation and for a civil penalty of not more than five thousand dollars for the first violation and not more than one thousand dollars per day if the violation continues.
7. No county or other political subdivision of the state may establish or continue any prohibition on or relating to animal testing, as defined in this section that is not identical to the prohibitions established in this section.
§ 2. This act shall take effect January 1, 2023.
1. The commissioner shall establish and maintain one or more laboratories with such expert assistants and such facilities as are necessary for routine examinations and analyses, and for original investigations and research in matters affecting public health. The laboratories shall be known as the Wadsworth center for laboratories and research.
2. The commissioner shall create within the Wadsworth center for laboratories and research a master of science degree program in the field of laboratory science, subject to approval of the board of regents and registration with the department of education.
(L.1953, c. 879. Amended L.1984, c. 597, § 1.; L.2008, c. 204, § 1, eff. Aug. 6, 2008.)
1. [FN1] The commissioner shall have authority:
(a) to make, at the expense of the state, examinations and analyses, at the request of any health officer or of any physician in accordance with the provisions of this article;
(b) to enter into contracts with laboratories in localities accessible to the various portions of the state for the prompt examination of specimens received from local health officers or physicians and for the immediate report thereon, at the expense of the state; provided that all such laboratories shall conform to the standards of efficiency established by the public health council, and that no obligation shall be incurred by the commissioner in excess of the sums available therefor.
(L.1953, c. 879.)
[FN1] So in original. No subd. 2 has been enacted.
1. For the purposes of this section, “environmental laboratory” is any facility that examines or is available for the examination of samples or specimens including, but not limited to: air, stack emissions, water, wastewater, surface water, ground water, recreational waters, swimming pools, leachate, land runoff, solid waste, hazardous waste, soil, sediments and vegetation, as well as any substance that could contribute to the pollution of or that could be contaminated by material contained in such samples or specimens. Such examinations shall be limited to the qualitative or quantitative determinations of the biological, chemical, radiochemical or physical characteristics of such samples or specimens for the purposes of public or personal health protection or the protection of the environment or natural resources. Environmental laboratories shall not include non-laboratory chemical testing associated with residential water softeners and residential swimming pools.
2. No environmental laboratory may perform any examination on samples collected in the state of New York for which the commissioner issues a certificate of approval for such examination unless the laboratory has been issued such certificate of approval. Such laboratory examinations shall conform to any conditions under which the approval is granted.
3. The commissioner may issue to laboratories certificates of approval covering laboratory examinations, including but not limited to, specific procedures or specialities within such categories as wastewaters, potable waters, sediments, solid wastes, and air, and may prescribe the conditions under which such approvals will be granted. Notwithstanding any other conditions which he may prescribe, such an approval shall not be issued hereafter to a laboratory, not heretofore approved, unless the director or other person in charge of such examinations shall possess such educational and technical qualifications as the commissioner shall prescribe.
4. No state agency, authority, county, city, including the city of New York, town, village, water district, sewer district or other political subdivision of the state shall contract with any laboratory for laboratory examinations for which the commissioner issues certificates of approval pursuant to subdivision three of this section, unless such laboratory has been issued such certificate.
5. Subject to the approval of the director of the budget, the commissioner shall charge adequate and reasonable fees for the periodic inspection of out-of-state laboratories.
6. Subject to the approval of the director of the budget, the commissioner shall charge laboratories fees to recover the cost to the department of operating this program. The commissioner may waive all or any part of such fee charges for laboratories operated by the state. Fees shall include the following:
(a) a basic amount of five hundred dollars to be charged to each laboratory;
(b) the balance of the program cost from:
(1) an additional amount to be charged to each laboratory proportional to total adjusted volume of analytes performed by the laboratory in the preceding year as defined in regulations of the department, the total amount collected from which shall equal fifty percent of the balance of the program costs;
(2) an additional amount to be charged to each laboratory proportional to the number of analytes for which such laboratory maintains its certification.
Subparagraph one of paragraph (b) of this subdivision shall not apply to government laboratories.
7. For those categories, procedures or specialities as specified in subdivision three for which the commissioner has issued certificates of approval, the commissioner shall within thirty days of receipt of an application for a certificate from a laboratory existing on or before April first, nineteen hundred ninety-three, which is initially required to obtain certification, review such application and issue an interim certificate of approval in the particular category, procedure or speciality to all laboratories which provide adequate documentation in their application that they are capable of performing quality work in the category, procedure or speciality under review. An interim certificate of approval in specified categories will remain valid until such time as the commissioner shall reach a determination on the application.
8. The commissioner may adopt and amend rules and regulations to effectuate the provisions and purposes of this title.
9. A person who intentionally violates or refuses or omits to comply with subdivision two of this section, or any regulation adopted pursuant thereto, is guilty of a misdemeanor, punishable upon conviction, by imprisonment for not more than one year or by a fine of not more than one thousand dollars or by both such fine and imprisonment. A second or subsequent conviction shall be punishable by imprisonment for not more than one year or a fine of not more than two thousand five hundred dollars or by both such fine and imprisonment.
10. The department may require an environmental laboratory to report laboratory test results to the department, or to any other health department in an electronic manner prescribed by the department.
(L.1953, c. 879. Amended L.1981, c. 517, § 1; L.1983, c. 614, § 1; L.1984, c. 901, § 1; L.1989, c. 685, §§ 1, 2; L.1992, c. 699, § 1; L.2010, c. 58, pt. A, § 24, eff. July 2, 2010, deemed eff. April 1, 2010; L.2017, c. 57, pt. M, § 2, eff. April 20, 2017.)
1. The director of any hospital in the department, with the approval of the commissioner, may enter into a contract with proper municipal or county officials under which the laboratory service of the hospital may be made available to municipalities or counties or parts thereof when in his judgment such a contract shall be in the interest of public health and not prejudicial to the interest or work of the institution.
2. The treasurer of the hospital, or the director thereof, if there is no treasurer, shall receive all moneys paid in consideration of such contract and pay the same into the general fund of the state.
(L.1953, c. 879.)
1. The commissioner is authorized to designate approved laboratories or institutions wherein properly conducted scientific tests, experiments or investigations, involving the use of living animals, may be performed or conducted.
2. (a) The commissioner shall promulgate rules under which such approvals shall be granted, and shall cause such rules to be published, and copies thereof shall be conspicuously posted in each such laboratory or institution.
(b) Such rules of the commissioner shall include requirements that all animals shall be kindly and humanely treated, properly fed and suitably housed, and that commensurate with experimental needs and with the physiologic function under study, all tests, experiments and investigations involving pain shall be performed under adequate anesthesia.
3. The commissioner or his duly authorized representative shall inspect such laboratories or institutions to insure compliance with the rules and standards promulgated by him.
4. (a) The approval of a laboratory or institution by the commissioner for the purposes herein set forth shall be limited to a period not exceeding one year but may be renewed from year to year upon proper application to the commissioner.
(b) Each such approval may be revoked at any time for failure to comply with the rules promulgated by the commissioner.
5. The performance of animal experimentation without approval by the commissioner as herein provided shall constitute a misdemeanor.
(L.1953, c. 879.)
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 [FN1] 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.
(Added L.2008, c. 169, § 1, eff. Jan. 7, 2009.)
[FN1] So in original (“product” should be “produce”).
It shall be unlawful for any laboratory or institution approved under this article, to purchase any dog or cat for experimental purposes unless the seller thereof shall provide proof of ownership of the animal of a sufficiency prescribed by the commissioner. Every such laboratory or institution shall keep a record of each such purchase with the name and address of the seller and a copy of the proof of ownership given at the time of the transaction.
(Added L.1966, c. 240.)
An agency as defined in subdivision three of section eighty-six of the public officers law may deny access to records or portions thereof concerning biomedical research or biomedical teaching conducted at an institution of higher education authorized by the state education department or at an institution within the state that receives state or federal funding to conduct such biomedical research or such biomedical teaching that, if disclosed, could endanger the life or safety of any person or would be reasonably likely to endanger the security of such biomedical research laboratory.
(Added L.2014, c. 440, § 1, eff. Nov. 21, 2014.)