Regulatory Analysis and Development, PPD
Animal & Plant Health Inspection Service
U.S. Department of Agriculture
4700 River Road, Suite 3C03
Riverdale, MD 20737-1238
Re: Docket No. 98-106-1
The American Society for Microbiology (ASM) would like to submit the following comments in response to the questions posed in the U.S. Department of Agriculture's January 28, 1999 Notice of Petition for Rulemaking to amend the definition of "animal" under the Animal Welfare Act (AWA) regulations.
The ASM is the premier educational, professional and scientific society dedicated to the promotion of the microbiological sciences and their applications for the common good. The Society represents more than 42,000 microbiologists, including researchers and science administrators in academic, industrial and government institutions working in a variety of areas. The ASM has an interest in standards and training in biomedical and other life sciences research. The ASM is a member of the National Association for Biomedical Research (NABR) and agrees with and will make reference to NABR's comments in the following response.
Question 1: Should the definition of "animal" in 9CFR part 1 be revised to include laboratory rats, laboratory mice, and birds, or any of the three?
Although rats, mice and birds are warm-blooded animals often used in research, rodents have been historically exluded from the purview of the USDA. The ASM does not believe expanding the definition of "animal" under the AWA is necessary. Animal care is already adequately regulated by the Environmental Protection Agency (EPA)/Food & Drug Administration (FDA) Good Laboratory Practice Standards (GLP), the U.S. Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). Broadening the definition of "animal" is unlikely to improve the strict and well-enforced conditions which already exist for laboratory mice, rats and birds. Further regulations will only lead to duplication of existing requirements and increased regulatory burdens without achieving any measurable improvement in the welfare of laboratory animals.
The ASM joins NABR in strongly urging that any regulation adopted by the USDA for laboratory rats, mice and birds not duplicate already established government standards and avoid additional administrative burdens on facilities and research investigators.
Question 2: If the definition of "animal" in 9CFR part 1 is amended to include laboratory rats, laboratory mice, and birds, should Animal Care regulate the care provided to these species in all circumstances covered by the AWA or in certain circumstances, such as use in research, only?
Including these three additional species in the definition of "animal" substantially increases the regulatory burden placed on APHIS. Limited resources have stretched APHIS' capacity to regulate facilities which fall within the current definition. NABR has projected that adding rats, mice and birds would increase the number of research animals under the APHIS Animal Care Unit by a factor of 20. Any redefinition which would expand the responsibilities of APHIS would also have to be accompanied by new funding and new human resources in order for the agency to carry out the additional regulatory duties.
The ASM is very concerned about potential additional burdens that may be placed on research facilities which already are in compliance with other federal regulations. Additional regulatory requirements will place an undue burden on researchers and could slow the pace of improving human health.
Question 3: The AWA requires that USDA inspect all research facilities at least once a year. Because of current and anticipated resources for AWA enforcement, any coverage of rats, mice, or birds would result in significantly reduced numbers of inspections for other AWA-regulated entities, such as dog and cat dealers, intermediate handlers and carriers, large and small zoos, and circuses. Should AWA enforcement activities be equal for all species covered by the AWA? If not, what should be the relative priorities?
APHIS needs to emphasize adequate enforcement in areas in which it has jurisdiction through the AWA. Expanding APHIS' regulatory responsibilities into an area that is already heavily regulated by other federal agencies only dilutes its enforcement capabilities in the areas in which it is the primary regulatory agency.
Question 4: If the definition of "animal" in 9CFR part 1 is amended to include laboratory rats, laboratory mice, and birds, how many additional facilities would come under USDA regulation.
The ASM defers any estimate of additional research facilities to NABR and the USDA. In its response, NABR provided an estimate of approximately 8,300 potential new registrants. Expenditure of funds to expand the role of the USDA would duplicate existing regulatory oversight in NIH funded facilities which receive AAALAC inspection. We suggest that AAALAC accredited facilities be exempt from USDA oversight of rodents.
In conclusion, numerous rules governing animal research currently exist. Expanding the oversight of APHIS will only add to the cost of doing biological research using rodents and birds and will not add to the welfare of these animals. The ASM recognizes the scientific and moral need for the proper care of all research animals and supports a rational consensus for the care and use of laboratory animals. It is in the interest of science that laboratory rats, mice and birds are used humanely in research and receive proper care and treatment. The improper care and use of research animals usually results in invalid scientific research results.