In response to the notice published July 10, 2000, in the Federal Register, the American Society for Microbiology (ASM) would like to comment on the proposed rule to clarify the definitions of pain and distress of animals used in research, testing, and teaching under the Animal Welfare Act (AWA).
The American Society for Microbiology is the premier educational and scientific society dedicated to the promotion of the microbiological sciences and their application for the common good. The Society represents more than 42,000 microbiologists, including scientists in academic, industrial and government institutions working in a variety of areas, including medical, molecular biology and genetics, environmental and food microbiology, and public health.
The ASM regards humane research in animals as essential to the pursuit of knowledge that will improve health and prevent disease in both humans and animals. The goal of biomedical research is to develop new insights to prevent, diagnose, treat and cure diseases that often cause pain and distress in human patients. The ASM recognizes the scientific and moral need for proper animal care and the obligation to avoid or minimize pain and distress in research animals whenever possible.
The proposed changes in regulations that are intended to enforce the Animal Welfare Act would not, in fact, accomplish that purpose. Instead, such changes would unduly add to administrative and bureaucratic burdens of researchers and institutions, and the costs of conducting research without the benefit of assisting research facilities to recognize, minimize or report animal distress in accordance with the AWA.
In regard to the questions posed by the USDA, the ASM submits the following comments:
The USDA is proposing the following definition: "Distress refers to a state in which an animal cannot escape from or adapt to the internal or external stressors or conditions it experiences, resulting in negative effects on its well-being." We believe the proposed definition would be ambiguous to researchers and other constituencies, and that it may not be possible to arrive at a definition that is not subject to misinterpretations. Furthermore, this definition would not enhance the ability of veterinarians, care and use committees or institutions in reporting pain and distress.
The vague language in the proposed definition would be subject to a variety of interpretations from one individual to another or from one committee to another and the Institutional Animal Care and Use Committees (IACUCS) would find it difficult to use. Definitions for recognizing distress in a procedure involving research animals should be based on scientific information and animal behavior consistent with scientific references cited in the 1992 NRC/ILAR report "Recognition and Alleviation of Pain and Distress in Laboratory Animals."
The Animal Welfare Act requires research facilities to report annually that they are following AWA provisions and that professionally acceptable standards are being followed during research or experimentation (7 USC 2143 (a)(7)(A)). Section 13(a)(7)(B)(iii) requires research facilities to include an explanation for any deviation from the standards promulgated under this section. Research facilities are required to submit assurance statements and explanations of deviations from required standards in annual reports to USDA. The ASM sees no useful reason to change the current reporting procedures for pain and distress. Vague definitions would result in flawed, unverifiable data that could be used to draw unsubstantiated conclusions for pain and distress. The best that can be expected is that the data on numbers of animals that experience pain and distress be based on the judgment of institutional committees and veterinarians.
Enhanced stewardship of animal welfare and the conduct of good science are best served by vesting responsibility in research facility programs and local IACUCS, who work with scientists, veterinarians, animal husbandry staff, government agencies and professional associations to promote humane care and use of research animals. This system places decisions about the potential for pain and distress in research protocols at the institutional level, where oversight for monitoring and mitigation of pain and distress are most effectively carried out.
The ASM is pleased to have the opportunity to provide comments on the proposed changes to the Animal Welfare Act and to provide assistance during the rule proposal process.