Laws

In the United States, the use of animals in research, testing, and education may be governed by federal, institutional, and industry oversight. Each differs in their oversight, standards, and enforcement. Although many people who are concerned about animals may have little faith in the system that oversees the conduct of animal research and testing, it is vital that we understand the system if we are to change and improve it.

Federal Oversight

Public Health Service (PHS)

PHS oversees many federal agencies, such as the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). PHS policy applies to all activities that are either supported or conducted by the PHS and involve live vertebrates, regardless of whether research is conducted in a private or government facility. In addition to complying with the Animal Welfare Act and other federal statutes and regulations related to the treatment of animals, PHS follows the Public Health Service Policy on Humane Care and Use of Laboratory Animals and the Guide for the Care and Use of Laboratory Animals.

PHS only requires written assurance of compliance through the Office of Laboratory Animal Welfare (OLAW), and recognizes Association for Assessment and Accreditation of Laboratory Animal Care International accreditation in their evaluations. Deficiencies are required to be reported by the facility’s Institutional Animal Care and Use Committee (IACUC), which reviews all research protocols and monitors animal care and use. The worst penalty for deficiencies is the loss of federal funding, a rare occurrence.

United States Department of Agriculture (USDA)

USDA is the federal agency in charge of enforcing regulations in support of the Animal Welfare Act (AWA), which covers animal care and handling by exhibitors, researchers, dealers, and transporters. USDA regulates certain warm-blooded animals used in research, exhibition, and the wholesale ‘pet’ trade (not including pet stores) with the major exceptions of birds, mice, and rats bred for use in research. Farmed animals are also not covered unless used in human health research. Though USDA receives annual reports from other federal agencies engaging in animal research, such as the Department of Defense, it does not inspect them.

The AWA and its corresponding regulations set out standards for handling, housing, sanitation, feeding, shelter from extreme weather, and veterinary care. There are also standards for the minimization of animal pain and distress; proper use of anesthetics, analgesics, and tranquilizers; and requirements for proper investigation into and consideration of alternatives to using animals.

AWA regulations require that research facilities establish Institutional Animal Care and Use Committees to oversee all animal research. In addition, USDA inspectors are required to perform at least one unannounced, annual inspection at each facility that uses AWA-listed species. USDA personnel will also respond to public complaints regarding the care of regulated animals, and investigate whether animal exhibitors, dealers, or researchers are operating without being registered or licensed. If deficiencies remain uncorrected, USDA can pursue legal action and/or confiscate animals. Ultimately, with research facilities, USDA can temporarily suspend their license, but can only confiscate animals not being used in research.

Institution Oversight - Institutional Animal Care and Use Committees (IACUCs)

Members of IACUCs represent the frontline between the research institution and the general public. It is ultimately their responsibility, along with the Institutional Official who is designated by the institution, to ensure to the federal government that proposals to conduct animal research are adequately reviewed and legally compliant, and that animals are cared for and treated according to certain criteria. The IACUC is often the only hope to assure that animals confined to laboratories receive even the minimum standards of care, but it has been documented that they do not always follow regulations or operate effectively.

IACUCs are required by both the Animal Welfare Act and Public Health Service policy, though each agency specifies differing member compositions. They each require at least one veterinarian and one person not affiliated with the research institution. AWA regulations specify that the Committee should consist of at least three members (including a Chairperson), whereas PHS Policy specifies that the Committee must have no less than five members.

Members of the IACUC are required to:

• review the facility’s animal care and use program at least every six months.
• inspect all of the institution’s animal facilities, including study areas, at least once every six months.
• submit reports of deficiencies to the Institutional Official along with a timetable for correcting the deficiencies.
• respond to public complaints or reports of noncompliance from institutional personnel by reviewing and investigating said concerns involving animal care and use.
• suspend activities using animals if they are non-compliant.
• review and approve, require modification, or disapprove of new animal research protocols or significant changes made to ongoing research activities.
• monitor animal use to assure compliance with protocols and policies.

In studies of common areas of noncompliance with PHS policy and USDA regulations, PHS/NIH and USDA found that most incidents were related to IACUCs. This means that, in some cases, no veterinarian or member of the community was present when protocols were reviewed, or that research was conducted without review or approval by the IACUC.

In a 2005 audit of its Animal Care unit, USDA found that IACUCs were not effectively supervising animal care and use practices, reviewing protocols, or ensuring that searches for alternatives were researched and used where appropriate. Another issue highlighted by the audit was the failure of inspectors to report any instances of serious or continuing non-compliance or suspend research activities that were in violation of regulations or policies. This means that research continued to be funded by the government without complying with basic guidelines for ‘humane’ care and use of animals. The most troubling findings, however, were deficiencies in the lack of planning for post-procedural pain and distress, failures to conduct a proper search into alternatives, and failures to provide a rationale for the numbers and species of animals used.

AAALAC is a private, non-profit organization that accredits facilities at the institution’s request. Over 750 facilities have been given AAALAC accreditation, and many do so for various reasons, including improved public relations, data comparison with other AAALAC-approved facilities, and to increase their potential for government funding. Recognizing species-specific requirements, AAALAC has guidelines regarding the care, housing, use, and management of all animals used in research, testing, and education from mammals to aquatic species and invertebrates. AAALAC follows the federal Guide for Care and Use of Laboratory Animals, and in addition to the filing of annual reports, facilities receive announced visits by AAALAC staff every three years.

All communications regarding AAALAC accreditation are kept confidential and cannot be released to the public. AAALAC has no legal authority and does not routinely penalize institutions that violate guidelines. However, AAALAC can revoke their accreditation from facilities with deficiencies in animal care and use.