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.
Laws & Regulations
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 applicable to research facilities as well as 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:
- The definition of an animal as "any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warm-blooded animal, as the Secretary may determine is being used, or is intended for use, for research, testing, experimentation, or exhibition purposes or as a pet." The definition excludes animals raised for food or their skins and, significantly, all purpose-bred rodents (rats and mice), as well as all non-mammalian species (e.g., birds, fish, amphibians, etc.).
- Mandatory registration or licensing of research facilities, animal dealers, and intermediate carriers and handlers with the USDA
- Establishment of minimum requirements for "handling, housing, feeding, watering, sanitation, ventilation, shelter from extremes of weather and temperatures, adequate veterinary care, and separation by species," as well as for "practices in experimental procedures to ensure that animal pain and distress are minimized, including adequate veterinary care with the appropriate use of anesthetic, analgesic or tranquilizing drugs, or euthanasia."
- A requirement "that the principal investigator considers alternatives to any procedure likely to produce pain or distress in an experimental animal." In cases where pain or distress are an unavoidable concomitant of an experiment, a veterinarian must be consulted to determine appropriate use of tranquilizers, analgesics and/or anesthetics, as well as pre- and post-surgical care by laboratory workers.
- A requirement to establish an Institutional Animal Care and Use Committee (IACUC) at each research facility, consisting of at least one licensed veterinarian and one member who is not affiliated in any way with the research facility. IACUCs are responsible for reviewing and approving all proposals for animal use; conducting at least semiannual IACUC inspections of all animal facilities; and supplying USDA with annual statistics concerning animal use by the research facility.
- A requirement that continuing education and training be made available to animal users.
- Special provisions intended to promote the psychological wellbeing of non-human primates.
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, which provide further detail 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 non-compliance 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 or other division of the Department of Health and Human Services:
- The establishment of guidelines for "proper care of animals to be used for biomedical and behavioral research" and for the "proper treatment of animals while being used in such research," including "the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals in such research."
- "The organization and functioning of animal care committees ... at each entity which conducts biomedical and behavioral research with funds provided under this Act..."
- Submission of the following by each applicant for a grant, contract or cooperative agreement:
(1) assurances satisfactory to the NIH Director that-
(A) the applicant meets the requirements of the guidelines established under paragraphs (1) and (2) of subsection (a) and has an animal care committee which meets the requirements of subsection (b); and
(B) scientists, animal technicians, and other personnel involved with animal care, treatment, and use by the applicant have available to them instruction or training in the humane practice of animal maintenance and experimentation, and the concept, availability, and use of research or testing methods that limit the use of animals or limit animal distress; and
(2) a statement of the reasons for the use of animals in the research to be conducted with funds provided under such grant or contract.
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.
Other Policies & Guidelines
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 that are 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 Department of Health and Human Services comprised of key agencies that conduct and/or fund health research, such as the National Institutes of Health, Food and Drug Administration, and 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:
- "No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with this Policy."
- "The Assurance shall fully describe the institution's program for the care and use of animals in PHS-conducted or supported activities. The PHS requires institutions to use the Guide for the Care and Use of Laboratory Animals ... as a basis for developing and implementing an institutional program for activities involving animals."
- "Each institution must assure that its program and facilities are in one of the following categories:
- Category 1 – Accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)
- Category 2 – Evaluated by the Institution. All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months"
Responsibility 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:
- Animal housing; husbandry; social and behavioral enrichment
- Animal monitoring; veterinary care; personnel qualifications and training; occupational health and safety
- Animal procurement and transportation; preventive medicine; surgery; pain avoidance and management; euthanasia
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)," which is then reviewed by AAALAC evaluators. In addition, AAALAC conducts its own site visit to the research facilities, the results of which determine the AAALAC accreditation status that is awarded (e.g., full, conditional, provisional, etc.). After a research facility earns an accreditation status, it must pay to be re-evaluated every three years in order to maintain its status. Currently, more than 730 organizations in 30 countries have earned AAALAC accreditation.
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