In a letter addressed to the Animal and Plant Health Inspection Service (APHIS), FASEB President Dr. Steven Teitelbaum expressed concern over a proposal to substantially increase the record keeping requirements for research animals covered by the Animal Welfare Act. In response to a call for comments posted in the April 11, 2003 Federal Register (Vol. 68, No. 70), FASEB concurred with the detailed analyses prepared by the American Physiology Society (APS) and the National Association for Biomedical Research (NABR). As stated in the letter, APHIS already requires animal health records under Policy #3 of the Animal Care Resource Guide. The proposed rule would impose rigid guidelines on what the medical records must contain and the format in which they must be kept. While Dr. Teitelbaum applauded APHIS efforts to "ensure the humane treatment of animals used in research," and reiterated FASEB's commitment to this principle, he cautioned "that the content of animal medical records is best left to the discretion of the attending veterinarian, in accordance with standard veterinary practice."
Although emphasizing FASEB's belief that adequate veterinary care is "an important component of laboratory animal care," Dr. Teitelbaum questioned whether APHIS's stated objective to use animal medical records as "a means of communication concerning the care being provided to animals" and "a basis for the [APHIS] to better assess the veterinary care programs of research facilities" was realistic. He pointed out that even detailed medical records are "only a small part of veterinary care" and further stated "that the current proposal merely imposes strict and burdensome policies that would limit the ability of the institutions' veterinarians to oversee veterinary care." The letter also highlighted specific, untenable requirements in the proposed rule, including those to list drug sensitivities of animals, of which currently, according to the FASEB President, "there exists no sound scientific" for evaluation.
FASEB is comprised of 22 societies with more than 60,000 members, making it the largest coalition of biomedical research associations in the United States. FASEB's mission is to enhance the ability of biomedical and life scientists to improve--through their research--the health, well-being and productivity of all people. FASEB serves the interests of these scientists in those areas related to public policy, facilitates coalition activities among Member Societies and disseminates information on biological research through scientific conferences and publications. June 4, 2003
Docket # 97-033-1Regulatory Analysis & Development PPD, APHIS, Station 3C714700 River Road -- Unit 118Riverdale, MD 20737-1238
The Federation of American Societies for Experimental Biology (FASEB) appreciates this opportunity to comment on the USDA's proposed amendment to the Animal Welfare Act (AWA) [Docket # 97-033-1]. We support the humane care of research animals and believe that such care is crucial to producing scientific data of benefit to both animal and humankind.
FASEB strongly believes that adequate veterinary care, which includes maintenance of animal health records, is an important component of laboratory animal care. In fact, the Animal Care Resource Guide's Policy #3 currently requires that adequate records be kept. Our principal concern with the proposed amendment is that it creates burdensome paperwork that will not ultimately benefit the health of research animals. We agree with the American Physiological Society (APS) and the National Association for Biomedical Research (NABR) that the content of animal medical records is best left to the discretion of the attending veterinarian, in accordance with standard veterinary practice.
Medical records, whether for animals or humans, serve to document the history of illness and medical care for that individual. The proposed amendment attempts to transform animal medical records into "a means of communication concerning the care being provided to animals" and "a basis for the [APHIS] to better asses the veterinary care programs of research facilities." While well-intentioned, the level of detail required to accomplish these new goals is unrealistic for a research environment. In addition, no matter how detailed, medical records are only a small part of veterinary care, and can only play a limited role in aiding APHIS inspectors to evaluate programs based upon accepted standards of laboratory animal care.
More specifically, we wish to concur with APS and NABR in their comments regarding Section 2.33, particularly in reference to requiring a "prognosis" for individual animals, which is inappropriate in a research setting, as well as to those provisions that clearly infringe on the professional judgment of the attending veterinarian ((b)(6)(iii)). Moreover, we agree that there exists no sound scientific means by which to evaluate drug-sensitivities in animals, and that all language referring to such should be removed from the background material.
The 22 member societies of FASEB, representing more than 60, 000 biomedical research scientists, applaud the USDA's effort to ensure the humane treatment of animals used in research and other settings. However, the current proposal merely imposes strict and burdensome policies that would limit the ability of the institutions' veterinarians to oversee veterinary care that is appropriate to the animal species and research program in use. We reemphasize our earlier point that it is the attending veterinarian who is most qualified to determine the content of animal medical records, provided they conform to existing, accepted practices. Thank you again for the opportunity to comment.
Sincerely,
Steven L. Teitelbaum, MDFASEB President
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