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The Animal Welfare Act (Laboratory Animal Welfare Act of 1966, P.L. 89-544) was signed into law by President Lyndon B. Johnson on August 24, 1966. It is the only Federal law in the United States that regulates the treatment of animals in research and exhibition. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act (otherwise known as the "AWA") as the minimally acceptable standard for animal treatment and care. The USDA and APHIS oversee the AWA and the House and Senate Agriculture Committees have primary legislative jurisdiction over the Act. Animals covered under this Act include any live or dead cat, dog, hamster, rabbit, nonhuman primate, guinea pig, and any other warm-blooded animal determined by the Secretary of Agriculture for research, pet use or exhibition. Excluded from the Act are birds, rats of the genus Rattus (laboratory rats), mice of the genus Mus (laboratory mice), farm animals, and all cold-blooded animals.

As enacted in 1966, the AWA required all animal dealers to be registered and licensed as well as liable to monitoring by Federal regulators and suspension of their license if they violate any provisions of the Animal Welfare Act and imprisonment of up to a year accompanied by a fine of $1,000. As of the 1985 AWA amendment that largely came as a result of the Silver Spring monkey case, all facilities covered by the Animal Welfare Act have been required to establish a specialized committee that includes at least one person trained as a veterinarian and one not affiliated with the facility. Such committees regularly assess animal care, treatment, and practices during research, and are required to inspect all animal study areas at least once every 6 months. The committees are also required to ensure that alternatives to animal use in experimentation would be used whenever possible.

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