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Federal Animal Care Regulations and Guidelines

All SDSU faculty, staff, and students whose research or teaching involves live vertebrate animals in some way, whether in the lab or in the field, must be familiar with and conform to regulations governing these activities.

The following is a synopsis of some of the more important regulations currently in force. The Federal Animal Welfare Act is the primary federal law regulating the use of animals in research. The Act originated in 1966 and has been amended several times since then. It is administered by the US Department of Agriculture (USDA). Research facilities must register with the USDA and submit to unannounced site visits by "animal care" field inspectors. Site visits are typically 1-2 times per year. Following the 1985 changes to the Act, the USDA restructured and extensively modified the standards to which research facilities are held. These modifications continued through Aug. 1991 and now have many similarities to the stricter standards of the PHS Policy and the ILAR Guide (see below). For instance, animal care and use committees, semi-annual inspections, review of animal use protocols, and clear lines-of-authority are now required.

The USDA administers the Animal Welfare Act (PL 89-544 and subsequent amendments) that establishes animal care standards for most laboratory animal species. The USDA regulations implement the Animal Welfare Act. Compliance requirements include establishment of an Institutional Care and Use Committee; semi-annual facility inspections and program reviews; training for all personnel involved with animal research; and submission of an annual report of the total number of regulated animals used in research and teaching, grouped according to potential pain and distress. It also requires documentation giving evidence of adequate veterinary care. Compliance with the Animal Welfare Act is monitored by periodic, unannounced inspections by the Animal Care (AC) arm of the Animal and Plant Health Inspection Service (APHIS).

The Public Health Service Policy on Humane Care and Use of Laboratory Animals is frequently called the PHS or NIH Policy. It was most recently updated August 7, 2002. It is based in Federal Law 99-158, the Health Research Extension Act. Basically the Policy applies to any institution receiving PHS funds for vertebrate animal research. Institutions must file a written Assurance that the Institution complies with the Policy, has established an appropriate line-of-authority, uses the ILAR Guide as a basis for operating the animal care program, maintains an Institutional Animal Care and Use Committee of specified responsibility, maintains records, and reports annually to the Office of Laboratory Animal Welfare (OLAW), formerly the Office for Protection from Research Risks (OPRR), including whether the Institution has gained or lost AAALAC accreditation. The Policy is based on self-regulation. On-site visits are rarely made; however, they do occur and institutions have had all of their Federal animal research funding frozen pending reestablishment of compliance with the Policy.

US Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training.

These nine principles were developed by the Interagency Research Animal Committee. The PHS policy implements and supplements these principles. These Principles must be adhered to by institutions receiving Federal funds for animal research. A copy of these Principles is available in the ILAR Guide (see below) on pages 116-117.

The ILAR Guide for the Care and Use of Laboratory Animals is generally called the ILAR Guide or "the Guide" (formerly referred to as the "NIH Guide"). It is the most influential document relating to animal care and use programs in existence in the United States. Institutions are required by the PHS Policy to follow it. It is the basis on which AAALAC accredits animal care programs. It covers all aspects of animal care programs and facilities - sometimes in considerable detail and often vaguely general. Many parts of the Guide are open to interpretation that permits each facility to tailor the animal program to the particular situation at hand. However, institutions carry some risk by making interpretations too inconsistent with the generally accepted national standard. This is a key responsibility of the Campus Veterinarian - to interpret the Guide for this facility while keeping these interpretations within reasonable limits of the generally accepted national practice (and within AAALAC's interpretations that tend to be rather strict).

AVMA Panel on Euthanasia

The US Fish and Wildlife Service is the federal agency charged with enforcing the Endangered Species Act and the Convention on International Trade in Endangered Species (CITES). These regulations designate endangered or threatened species and, with limited exceptions, prohibit their use. Institutions that seek to use species covered by the Act for scientific research must obtain a permit from the Federal Wildlife Permit Office. If an institution needs to import an endangered or threatened species, appropriate export and import documents must be obtained in advance as required by CITES.

The California Department of Fish and Game administers state laws regulating the importation, quarantine and housing of nonindigenous wildlife species and the collection and use of California native species (California Administrative Code, Title 14, Sections 671-671.4). Institutions seeking to import restricted or prohibited species for research must obtain the appropriate permits through the Animal Welfare section of this department. These regulations are intended to protect native Californian wildlife and the public from diseases that may be carried by imported wildlife.

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To contact program admin support:

Division of Research Affairs

Animal Care and Use Program
Gateway Center, 3rd floor

San Diego State University
5250 Campanile Dr.
Mail Code 1933
San Diego, CA 92182

Phone: 619-594-0905