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AKO

Veterinary Medicine: Animal Use in Biomedical Research

Laws, Regulations, & Guidelines
AFRIMS is committed to the humane care and use of animals in biomedical research by strict adherence to federal, state, and local regulations for animal use. In addition, all research must comply with DoD regulations in accordance with AR 70-18. The following sections summarize the laws, regulations, and guidelines upon which animal care and use are based. Included at the end of this section are copies of AR 70-18 and DoD Directive 3216.1. In response to intense congressional interest in animal use in the Department of Defense, these latter two documents are in the process of being updated.

 

Animal Welfare Act (7 U.S. Code Section 2131 et. seq.):

          - The Animal Welfare Act (AWA), first passed in 1966 and amended in 1970 and 1976, contains provisions to ensure that animals intended for use in research facilities or for exhibition purposes receive humane care and treatment.

          - The law regulates the transportation, purchase, sale, housing, and treatment of animals used in research, for exhibition, and for certain other purposes.

          - The 1985 amendment to the AWA, termed Improved Standards for Laboratory Animals, provides minimum standards for animal care, exercise for dogs, and physical environments adequate for the psychological well-being of nonhuman primates.

          - The amendment also specifies appropriate use of anesthetics, analgesics, and euthanasia techniques; prohibits multiple major survival surgery except when scientifically justified; and requires each research institution to have an Institutional Animal Care and Use Committee (IACUC).

          - In 1992, the AWA was amended again as part of the Food, Agriculture, Conservation and Trade Act. Termed Protection of Pets, this amendment extended holding periods for dogs and cats at pounds and shelters, giving owners more time to claim their lost pet prior to being released for sale. The amendment also set forth requirements for certification to accompany random source dogs and cats sold by dealers.

          - The Animal Care Policy Manual and other USDA Animal Care publications are available to provide further guidance on the Animal Welfare Act.

Public Health Service Policy on Humane Care and Use of Laboratory Animals:
          - This Policy, made into law by the Health Research Extension Act of 1985, is applicable to all PHS-conducted or supported activities involving animals conducted in the United States, Puerto Rico, or any other US territory. Institutions outside the US receiving PHS support must comply with this Policy or provide evidence that acceptable standards for the humane care and use of the animals will be met.

          - The Office for Protection from Research Risks (OPRR) at the National Institutes of Health has responsibility for the administration of this Policy on behalf of the PHS. A prerequisite for an institution to receive PHS funds is the filing of a Letter of Assurance with OPRR.

          - All Assurances are evaluated by OPRR to determine the adequacy of the institution's proposed program for the care and use of animals.

          - Each Institute submitting an Assurance must fit into one of two categories: Accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) or evaluated by the Institution via semiannual IACUC inspections. AFRIMS is in the first category and does have a Letter of Assurance on file with OPRR.

The Guide for the Care and Use of Laboratory Animals:

          - The Guide is considered to be the gold standard for animal care and is the primary document used in the accreditation of animal research programs by AAALAC.

          - The 'new' Guide was recently revised and released in January 1996.

          - Sponsored by the Institute of Laboratory Animal Resources, Commission of Life Sciences, National Research Council, the Guide is meant to assist institutions in caring for and using animals in a scientifically sound and humane manner.

          - This version of the Guide stresses performance based standards as opposed to engineering goals. This puts greater responsibility on the user to interpret the guidelines properly.

          - The Guide is organized into four chapters: institutional policies and responsibilities; animal environment, housing, and management; veterinary medical care; and physical plant. Responsibilities of institutional officials, Institutional Animal Care and Use Committees, investigators, and veterinarians are discussed in each chapter.

          - While the types of animals covered by law in the AWA is limited, the Guide covers all vertebrate species used in research teaching, and testing.

Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC):

          - AAALAC is a nonprofit organization formed in 1965 to promote high quality standards of animal care through a voluntary accreditation program.

          - Animal care facilities of applicant institutions are visited and thoroughly evaluated by at least two experts in laboratory animal science.

          - During the site visit, the visitors inspect the facilities, review the program documentation, and talk to AFRIMS's command group, attending veterinarians, animal care staff, IACUC, selected investigators, and responsible administrators.

          - The AAALAC's Site Visitor's detailed report and the accreditation application are reviewed by the Council on Accreditation to determine if the institution follows the standards listed in the Guide. Institutions can receive full accreditation, provisional accreditation, or can have accreditation withheld. Once a facility is accredited, inspections occur every three years and reports must be filed annually by the institute to document changes in the program, personnel, or facility. AFRIMS is fully accredited.

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