6) Who determines the conditions under which primates are kept in captivity?
There are four federal agencies that regulate the use of animals in research.
- One is the Public Health Service (PHS), which issues the PHS Policy on Humane Care and Use of Laboratory Animals. The recommendations in this policy statement have the force of law, under the Health Research Extension Act (PL99-158) passed in 1985. Among other things, this policy requires the existence of an Institutional Animal Care and Use Committee (IACUC) at each institution that conducts research with funds from federal sources. The IACUC is composed of individuals from the institution and the community, and they review (and must approve) all proposed research projects involving live vertebrates. They also conduct inspections of facilities.
- The Institute of Laboratory Animal Resources (ILAR) of the National Research Council, National Academy of Sciences writes the ILAR Guide for the Care and Use of Laboratory Animals, which is published by the National Academy Press. The National Institutes of Health (NIH) funds ILAR to write the document. Investigators that receive funds from PHS (including NIH and the Centers for Disease Control and Prevention) for research involving live vertebrates, must adhere to these guidelines, which address the day-to-day aspects of caring for laboratory animals.
- The United States Department of Agriculture's Animal Plant and Health Inspection Service (APHIS) is responsible for enforcing the Animal Welfare Act, the second principal law governing the use of animals (Title 7, Sections 2131 et seq. of the U.S. Code, amended in 1985 by PL99-198). The Act was created in response to public concern about animal welfare, and covers species such as cats and dogs, as well as primates. The regulations created by the USDA to enforce the Animal Welfare Act do not cover the most common species of laboratory animals, rats (genus Rattus) and mice (genus Mus), nor do they cover agricultural uses of farm animals. The Animal Welfare Act requires that APHIS perform at least one compliance inspection per year on each research facility that uses animals in experimentation. USDA sets the same minimum for all regulated entities that use animals, including research facilities (i.e., hospitals, universities, diagnostic laboratories, and private firms in the pharmaceutical and biotechnology industries), dealers, exhibitors, and in transit carriers (e.g., airlines). Compliance inspections are unannounced, meaning that the institution to be inspected is not given advanced notice that an inspection is planned. (Reference: Report of the Secretary of Agriculture to the President of the Senate and Speaker of the House of Representatives. Animal Welfare Enforcement, Fiscal Year 1994. USDA, APHIS 41-35-034).
- Food and Drug Administration (FDA) has regulations pertaining to Good Laboratory Practices. These regulations address animal care issues and apply to safety studies of any food additive, drug, or medical device intended for humans that use animals, and require extremely detailed records of all aspects of study. FDA requires adherence to the ILAR Guide.
Finally, one independent, non-Federal organization that is involved in animal welfare in captivity is the American Association for the Accreditation of Laboratory Animal Care (AAALAC). Institutions voluntarily join AAALAC, which inspects facilities on a regular basis every three years. They then accredit those institutions that meet the highest standards for animal care. Institutions proudly display their accreditation by AAALAC. Click here to see AAALAC's Rules for Accreditation.
These FAQs were written by John P. Capitanio, Ph.D., with assistance and updates from the Publications Committee of ASP. Special thanks to Jim Moore, Ph.D., and Phil Tillman, D.V.M.
Approved by the Board of Directors 30 June 1998.