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U.S. Department of Health and Human Services

Animal & Veterinary

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How FDA Takes Care of Animals: AAALAC Accreditation Achieved and Maintained

by Mack A. Holt, D.V.M., Director, CVM Office of Animal Care and Use
FDA Veterinarian Newsletter May/June 2005 Volume XX, No III

The Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC, International) is a private, nonprofit organization that promotes the humane treatment of animals used in science.

AAALAC accreditation is achieved through institutional voluntary submission to assessment and accreditation of animal care and use programs. Achievement of “fully accredited” AAALAC status is considered to be the “Gold Stand-ard” in laboratory animal care and use. This symbolizes to the public and biomedical research communities that the accredited program is operating at standards that epitomize quality animal care and use.

Currently, more than 670 animal care and use programs in 24 countries have earned the “Gold Standard” of accreditation. These programs include academic institutions, commercial organizations, agricultural research programs, government agencies, hospitals, nonprofit organizations, biotechnology, and pharmaceutical companies. Once initial accreditation is achieved, the accredited program is site visited or peer reviewed once every three years.

All of the animal care and use programs in the Food and Drug Administration (FDA) are operating under the “Gold Standard” of accreditation. FDA scientists participating in research and testing using in vivo test systems understand the critical relationship between quality animal care and quality science.

The first two FDA animal care and use programs that achieved accreditation did so in 1977. Those programs were the Center for Biologics Evaluation and Research and the National Center for Toxicological Research. Over a period of 25 years during the evolving stages of FDA animal care and use programs, “full accreditation” status has been achieved and maintained for all of the Agency’s programs using in vivo test systems. The chronology of these accreditations has been as follows: Center for Veterinary Medicine (CVM), 1993; Center for Drug Evaluation and Research (CDER), 1999; Center for Devices and Radiological Health (CDRH), 2000; Center for Food Safety and Applied Nutrition, 2001; and Office of Regulatory Affairs, 2003. Since the initial accreditations, all programs have had multiple site visits and have maintained “fully accredited” status.

As part of a long-range plan by FDA to construct facilities and consolidate multiple FDA entities as the FDA/Federal Research Center at White Oak, in Silver Spring, MD, the animal-research based programs of CDER and CDRH were consolidated under a Memorandum of Agreement. These consolidated programs became the White Oak Animal Program in December 2003. Inasmuch as the animal care and use programs of CDER and CDRH had achieved and maintained “full accreditation” status, AAALAC International granted permission to FDA to let both programs function as a single consolidated program under the “Gold Standard.”

When new buildings are constructed that are to accommodate animals used in research, testing and teaching, a question often asked is whether the buildings will be AAALAC accredited. An AAALAC evaluation considers all aspects of an animal care and use with buildings being a part of the overall program. Such an evaluation would include an organization’s procedures and overall performance in the area of animal care and use in research, education, testing, or breeding. The basic components that are evaluated include institutional policies, animal husbandry, veterinary care, and physical plant. AAALAC evaluations emphasize performance-based measures that make allowance for greater flexibility in the achievement of desired outcomes in animal use.

AAALAC does not impose prescriptive measures in the achievement of desired outcomes. The evaluation process takes into consideration the fact that each animal care and use program is unique. Differences between programs may be a function of program mission, types of animals involved, or outcomes desired. FDA’s AAALAC accredited programs are all unique. This uniqueness can best be illustrated in the CVM AAALAC accredited Office of Research animal care and use program. It conducts applied research in support of regulatory decision-making in a state-of-the-art research complex. This program does not include just one category of animals. Instead, the Office of Research complex is facilitated to accommodate small laboratory animals, a variety of agricultural animals, aquatic species, and companion animals.

FDA is proud that all of its animal care and use programs are counted among the programs operating under the “Gold Standard” status. The emphasis and commitment given to the derivation of quality regulatory decisions must parallel that of quality animal care and use. If data generated from use of in vivo test systems is utilized to support or validate regulatory science-based decisions, its source must be of “Gold Standard” origin.