DHHS. National Institutes of Health.
Public Law 99-158, November 20, 1985, "Animals In Research"
Other Federal Laws
See sections 351 and 354-360F for references to good laboratory practices under the Food and Drug Administration.
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).
Federal Hazardous Substances Act (FHSA) ( pdf | 287 KB )
U.S. Consumer Product Safety Commission.
The Federal Hazardous Substances Act (FHSA) requires that certain hazardous household products ("hazardous substances") bear cautionary labeling to alert consumers to the potential hazards that those products present and to inform them of the measures they need to protect themselves from those hazards.
Under the FHSA, animal testing is not mandatory, it is one possible option that can be used to determine the biological response and appropriate cautionary labeling for a consumer production. For more information, see Recommended Procedures Regarding the CPSC's Policy on Animal Testing.
U.S. Food and Drug Administration.
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.
Final Rules: Good Laboratory Practices
Final rules published in the Federal Register regarding changes to the FDA's Good Laboratory Practice regulations.
§ 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.
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)
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.