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Other Federal Laws

Endangered Species Act (ESA) of 1973   html

US Fish and Wildlife Service.

The Endangered Species Act, passed in 1973, was passed to protect and recover imperiled species and their ecosystems. Responsibility for implementing the Act is shared jointly by the US Fish and Wildlife Service (land and freshwater species) and the NOAA National Marine Fisheries Service (marine and andromous species).

Toxic Substances Control Act (15 USC Section 2601 et seq.)   html

U.S. Environmental Protection Agency.

This law provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Drugs, cosmetics, foods, food additives, pesticides, and nuclear materials are exempt from TSCA.

Sec. 2603 (Testing of chemical substances and mixtures) gives authority to EPA to develop regulations on good laboratory practices for conducting studies.

For background information about the TSCA and detailed links on chemicals testing, see Summary of the Toxic Substances Control Act (Environmental Protection Agency).

Good Laboratory Practice Standards (40 CFR, Part 792)   html

Government Printing Office.

These regulations were developed by the EPA to ensure the quality and integrity of data submitted under the TSCA and prescribe good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical fate testing.

Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR, Part 58)   html

§ 58.1 Scope. These regulations apply to research studies on products regulated by the Food and Drug Administration (FDA), including food and color additives, animal food additives, humane and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512-516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act.

Bioresearch Monitoring: Good Laboratory Practices (GLP) References and Guidance   html

US Food and Drug Administration. Office of Regulatory Affairs.

Answers to frequently asked questions about GLP. Also includes amendments and final rules related to GLP.

Animal Rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products)   html

Government Printing Office.

These sections contain information on the use and development of animal models when creating drug or biological products for approval or licensure with FDA.

Public Health Service Act (42 USC, Section 201-300)   html

See sections 351 and 354-360F for references to good laboratory practices under the Food and Drug Administration.

Federal Food, Drug, and Cosmetic Act (21 USC, Section 301-399)   html

U.S. Food and Drug Administration.

Final Rules: Good Laboratory Practices   html

 

Final rules published in the Federal Register regarding changes to the FDA's Good Laboratory Practice regulations.

Health Research Extension Act of 1985   html

DHHS. National Institutes of Health.

Public Law 99-158, November 20, 1985, "Animals In Research"

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