Rules and Regulations

Federal Laws, Regulations and Guidelines Governing Biomedical Research Using Animals

When animals are used in biomedical research, the following laws, regulations and guidelines govern their care:

U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training.

A set of principles that underlie current federal regulations was developed in 1984 by representatives from all federal agencies that use or fund biomedical research. 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
* research scientists and those caring for the animals be properly trained and qualified

These requirements are sometimes summarized as the 3R's:

1. Reduction-using the minimum number of animals necessary.
2. Refinement-enhancing animal welfare and ensuring the best conditions possible.
3. Replacement-using other models when appropriate.

Animal Welfare Act (AWA)
The Animal Welfare Act sets federal standards for all aspects of care for laboratory animals. It was enacted into law in 1966 and has been amended by the U.S. Congress several times. The act applies to all public and private research facilities in this country.

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 each year verifying compliance and indicating the number and species of animals used. The USDA is required to inspect each facility at least once a year, unannounced, 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 fine the institution or close the facility.

Institutional Animal Care and Use Committee: The 1985 amendments to the AWA required all research facilities using animals to establish an Institutional Animal Care and Use Committee (IACUC). The committee ensures that applicable federal, state, and local laws and regulations are met, reviews and approves procedures involving animals before they take place, and inspects facilities twice a year for compliance with the AWA.

IACUC.org, a resource page for IACUCs, provides a wealth of information about these important committees.

The 1996 edition of National Institutes of Health publication, Guide for the Care and Use of Laboratory Animals provides further information about the committee and its role.

Our Ohio affiliate, OSERA, provides additional information about IACUCs, including an interview with a member.

The Purpose, Procedures, and Operations Manual from the IACUC at the University of Washington is provided as an example.

Health Research Extension Act.
This 1985 federal law applies to facilities that receive funding to do research from the federal government, in contrast to the Animal Welfare Act, which applies to all facilities regardless of the source of funds. The legal and regulatory requirements of the act are very similar to those of the Animal Welfare Act, and they apply to all research supported by the U.S. Public Health Service (PHS) involving vertebrate animals, including rats, mice and birds. The PHS includes the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention. PHS grants or contracts can be suspended or revoked for non-compliance with this law.

Voluntary Professional Standards. Research animals are well cared for, under the supervision of specialized veterinarians. 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). Visit their web site for a free copy of the Guide for the Care and Use of Laboratory Animals. 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 is considered to be the research community equivalent of the "Good Housekeeping Seal of Approval."

Federal Requirements for Animal Testing. Several federal laws require that the public be protected from hazardous products. The federal regulations that implement these laws require animal testing. There are four main 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 these products 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.

Some information in this section was adapted with permission from the North Carolina Association for Biomedical research (NCABR).