The US system of regulation and oversight of animal care and use for testing and research consists of patchwork of legislative, regulatory, and guidance tools, independently established and overseen by various federal agencies and independent scientific bodies.
Animal Welfare Act
The Animal Welfare Act (AWA; 7 U.S.C. § 2131-2156), enacted in 1966 and amended periodically since then, serves as the primary federal law governing the care and use of at least some of the animals used in scientific experiments. The Act and its regulations set minimum standards for research facilities and animal dealers and transporters.
Enforced by the Animal and Plant Health Inspection Service of the US Department of Agriculture (USDA/APHIS), the AWA provides for the following:
In addition to the general provisions above, the USDA has promulgated a series of implementing regulations under Title 9, Chapter 1, Subchapter A of the US Code of Federal Regulations providing further details concerning institutional requirements under the AWA. Pursuant to the regulations, USDA inspectors are required to perform at least one unannounced annual inspection at each facility that uses AWA-listed species. USDA personnel may also respond to public complaints regarding the care of regulated animals and are authorized to temporarily suspend a research facility’s license in cases of clear noncompliance with the AWA or its regulations.
Health Research Extension Act
The Health Research Extension Act of 1985 (Public Law 99-158) requires the following in relation to animal experiments funded through the National Institutes of Health (NIH) or other division of the Department of Health and Human Services (HHS):
The Health Research Extension Act does not provide for a government inspectorate to perform site visits of research facilities to confirm the accuracy of written assurances. However, facilities are required to report deficiencies to the NIH Office of Laboratory Animal Welfare (OLAW) for review.
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
Federal policy provides that “(w)henever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible Institutional Official shall ensure that these principles are adhered to.” The principles in question are nine common sense criteria intended to ensure that vertebrate animal experiments are as humane and scientifically meritorious as possible.
Public Health Service Policy on Humane Care and Use of Laboratory Animals
The Public Health Service (PHS) is an umbrella body within the HHS comprising key agencies that conduct and/or fund health research, such as NIH, the Food and Drug Administration, and the Centers for Disease Control and Prevention. PHS policy extends and elaborates on the requirements of the Health Research Extension Act and applies to all scientific research involving vertebrate animals that is conducted or funded by any PHS agency.
Specific provisions include the following:
OLAW is responsibile for coordination and implementation of PHS policy rests with the NIH Office of Laboratory Animal Welfare (OLAW). In addition to its direct oversight function, OLAW also works to promote education and voluntary compliance on the part of animal users through regional workshops and conferences, including the flagship IACUC 101 series.
National Research Council Guide for the Care and Use of Laboratory Animals
The Guide to the Care and Use of Laboratory Animals is a 125-page publication prepared by the National Research Council (NRC) Institute for Laboratory Animal Resources to provide specific guidance and advice to research facilities in the following aspects of animal care and use:
As mentioned above, PHS policy calls upon covered institutions to adhere to the NRC Guide.
Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International
AAALAC International is an accrediting organization that offers its services to research facilities that wish to obtain third-party certification of compliance with the NRC Guide for the Care and Use of Laboratory Animals. Facilities seeking AAALAC accreditation are required to produce a program description detailing “all aspects of the animal care and use program (policies, animal housing and management, veterinary care, and facilities)” for AAALAC evaluators to review. AAALAC then conducts site visits of the research facilities to determine accreditation status (e.g., full, conditional, provisional, etc.). After a research facility earns an accreditation status, it must pay to be reevaluated every three years in order to maintain its status. Currently, more than 730 organizations in 30 countries have earned AAALAC accreditation.