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1 1 (December 28, 2023)

handle is hein.crs/govenvt0001 and id is 1 raw text is: I ~ or nin &on I flesedrch Service Iera I ave IeIa~ 'e 914 0 Updated December 28, 2023 Animal Use in Federal Biomedical Research: A Policy Overview Animals commonly are used in federally funded biomedical research for a number of reasons-for example, to better understand the biology of disease or to test the safety and efficacy of medical products. The existing federal policy framework generally seeks to reflect a balance of animal welfare considerations with the scientific value of such research. Federal policy also encourages the development and use of alternatives to animals where possible. Different policies apply, depending on the type of animals used, the entity conducting the research, and the source of funding. Many of the policy requirements place the primary responsibility for ensuring animal welfare on the funded research institution (e.g., a university). Separately, enacted legislation and other policy efforts have sought to reduce, refine, and replace the use of animals in biomedical research (principles known as the Three Rs). This In Focus provides an overview of certain laws and policies- focusing on the Animal Welfare Act (AWA, 7 U.S.C. §§2131-2156) and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy)-that guide animal use and welfare in federally funded biomedical research. The Food and Drug Administration (FDA) also has regulations governing animal welfare, including for studies on regulated products (21 C.F.R. Part 58), that are not discussed in detail herein. Background Biomedical research frequently incorporates animal models to study biological processes, diseases, and potential treatments. Animal models, in this context, refer to living organisms used to simulate aspects of human biology. Table 1 provides a summary of selected animals used in research and their common uses. Table I. Selected Uses of Animals in Biomedical Research Animal Summary Mice and Rats Comprise an estimated 95% of all laboratory animals. Modern genetics has enabled rodent models for many human diseases and biological systems. Nonhuman Because of biological similarity to humans, used Primates for studying complex systems for which other animals are incomparable, such as immune, reproductive, and neurological systems. Constitute an estimated less than 0.5% of all biomedical research animals. Dogs and Dogs are used to study cardiovascular disease, Cats spinal cord injury, medical imaging, diabetes, neurology, and infectious diseases. Cats are used for neuroscience and infectious diseases. Swine (Pigs) Pigs are used to study heart and lung diseases, skin conditions, reproduction and fetal development, and organ transplantation. Source: CRS review of scientific and policy literature. Table is not exhaustive of all research uses for the selected animals or of all animals used in federal biomedical research. Animal Welfare Act The AWA governs the humane care and treatment of certain animals that are intended for research, bred for commercial sale, exhibited to the public, or commercially transported. The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) develops and administers AWA regulations. These regulations (9 C.F.R. Part 2) establish minimum standards of care and treatment for certain animals used in research, among other uses. USDA must consult with the Secretary of Health and Human Services (HHS) before issuing AWA regulations. With respect to research, the AWA requires nonfederal research facilities to register with APHIS and all research facilities (federal and nonfederal) to undergo periodic inspections, keep records, submit annual reports to APHIS, and train personnel involved in animal care and treatment on humane practices. Research facilities, both federal and nonfederal, must establish an Institutional Animal Care and Use Committee (IACUC), which reviews the facility's compliance with AWA regulations and reports violations to APHIS (nonfederal facilities) or the head of the agency (federal research facilities). A federal agency may revoke a project's funding if it finds that an AWA violation has not been remedied following a warning. Research facilities may be subject to civil penalties for AWA violations. There are limitations on the application of the AWA to research, since it does not authorize USDA to regulate the design, guidelines, or performance of research or to interrupt the conduct of research (7 U.S.C. §2143(a)(6)). Types of Animals: The AWA applies to any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or other warm-blooded animal determined by USDA to be used for research or exhibition or as a pet. The AWA's statutory definition of animal excludes certain animals, including birds bred for research, and rats (of genus Rattus) and mice (of genus Mus) bred for research. Covered Entities: Under the AWA, research facilities are those entities that use live animals for research, tests, or experiments and that (1) purchase or transport live animals or (2) receive federal funds. These entities include federal and nonfederal facilities. Public Health Service Policy The PHS Policy addresses the welfare of animals used in research conducted or supported by PHS agencies. These include the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, FDA, and others in

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