FREQUENTLY ASKED QUESTIONS
The Care of Use of Animals in Biomedical Research
15. WHAT LAWS, REGULATIONS AND GUIDELINES GOVERN ANIMAL RESEARCH?
(Taken from Unit II, Chapter 5, of the
Rx for Science Literacy teacher manual.)
A number of laws, regulations and guidelines govern the use and care of animals in biomedical research and testing. The major elements of these are summarized below.
Federal Requirements for Animal Testing: Several federal laws require that the public be protected from hazardous products. To ensure this, federal regulations exist to implement these laws. These regulations require animal testing, either explicitly or implicitly. There are four principal federal agencies involved in administering these regulations:
- Food and Drug Administration (FDA): The FDA is responsible for administering statutes regulating human and animal food and drugs, medical devices, biological products, cosmetics, color additives and radiological products. The FDA requires that laboratory animal tests be conducted for prescription and over-the-counter drugs before they can be tested in humans.
- Environmental Protection Agency (EPA): The EPA uses data derived from animal tests and other sources to identify and regulate substances in the environment, such as air or water pollutants and wastes, that might be hazardous to humans and animals.
- Consumer Product Safety Commission (CPSC): The CPSC relies on animal data in identifying and regulating risks to consumers from household and other products.
- Occupational Safety and Health Administration (OSHA): OSHA uses data from animal tests and other sources to set regulations that protect workers in the workplace.
Federal Laws, Regulations and Guidelines Governing Biomedical Research Using Animals: When animals are used in biomedical research, their care is governed by the following laws, regulations and guidelines:
- U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training:
In 1984, representatives from all federal agencies that use or fund biomedical research developed a set of principles that underpin the current system of federal regulations. These include requirements that:
- procedures involving animals be relevant to human or animal health;
- the minimum number of animals be used to obtain valid results;
- alternatives to animals be considered;
- animal pain or distress be avoided or minimized;
- living conditions for animals be appropriate for their species; and
- research scientists and those caring for the animals be properly trained and qualified.
- Animal Welfare Act (AWA): The AWA was enacted into law in 1966 and has been amended by the U.S. Congress several times, most recently in 1991. The act applies to all public and private research facilities in this country.
- Species covered: The species of animals included under the act are determined by the Secretary of the Department of Agriculture (USDA) and currently include guinea pigs; hamsters; gerbils; rabbits; dogs; cats; nonhuman primates; marine mammals; farm animal species, when used in biomedical research; and warm-blooded wild animals. Rats, mice and birds are not included among the species covered.
- USDA licensing, reporting and inspection requirements: All research facilities covered by the law must be registered with the USDA and comply with the USDA animal welfare regulations. Each facility must report to the USDA annually, verifying compliance and indicating the number and species of animals used. The USDA is required to inspect each facility at least once a year on an unannounced basis to ensure compliance with these standards. More frequent unscheduled inspections are made if significant deficiencies are identified. If the USDA inspectors find violations of any part of the act, they will allow the facility a limited time to correct them. If the violations are not corrected, the USDA can levy a fine against the institution or close the facility.
- Animal Care and Use Committee: The 1985 amendments to the AWA required all research facilities to establish an Institutional Animal Care and Use Committee (IACUC) that is responsible for reviewing and approving procedures involving animals before they take place and for inspecting facilities twice a year for compliance with the AWA.
- USDA Animal Welfare Regulations: In order to implement provisions of the Animal Welfare Act, the USDA developed detailed regulations defining the responsibilities of research facilities, the duties of IACUCs and specific standards for animal care.
- Before animals can be used: Before scientists can use any animals, they must assure the IACUC that any animal pain and distress is minimized; they have considered alternatives to using animals, especially in those experiments likely to cause pain and distress; and that the activities do not unnecessarily duplicate previous experiments.
- When animals can be used: Animal welfare standards for specific species include requirements for handling, housing, cage size, feeding, watering, sanitation, ventilation, temperature, humidity and veterinary care. Research facilities must also have individualized, written exercise programs for dogs as well as written plans for addressing the psychological well-being of nonhuman primates.
- Health Research Extension Act: This 1985 federal law applies to all facilities that receive funding to conduct research (e.g., grants and contracts) from the federal government. This is different from the Animal Welfare Act, which applies to all facilities regardless of the source of funds. This law promulgated regulations based on long-standing policies supported by the Public Health Service (PHS) governing the use of animals in research. PHS includes the National Institutes of Health, the Food and Drug Administration and the Centers for Disease Control and Prevention. The legal and regulatory requirements of the act are very similar to those of the Animal Welfare Act. They apply to all PHS-conducted or supported research involving vertebrate animals, including rats, mice and birds. PHS grants or contracts can be suspended or revoked for noncompliance with this law.
- Voluntary Professional Standards: Since 1965, the scientific community has sponsored an independent, peer review accreditation program under the auspices of the American Association for Accreditation of Laboratory Animal Care (AAALAC). AAALAC promotes the highest standards of animal care and use through a program of periodic inspection of research facilities that exceeds existing laws and regulations. AAALAC accreditation, which has been approved for 670 research facilities, is considered to be the research community equivalent of the “Good Housekeeping Seal of Approval.”
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