Regulatory Analysis and Development
Animal and Plant Health Inspection Service
4700 River Road
Riverdale, MD 20737-1238
Re: [Docket No. APHIS-2006-0183]
The American Society for Microbiology (ASM) is responding to the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service’s (APHIS) request for comments on the proposed amendment to the brucellosis regulations to facilitate research conducted on brucellosis exposed or infected animals (Docket No. APHIS-2006-0183). The following comments were developed by the ASM Committee on Agriculture and Food Microbiology (Committee), of the Public and Scientific Affairs Board.
The ASM is the largest single life science society with more than 42,000 members, including scientists in academic, industrial, clinical, and government institutions, working in areas related to basic and applied research, the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, the environment, animal health, and water and food safety. The ASM applauds APHIS’s efforts to enhance public health protection through changes in the brucellosis regulations, providing an exception for brucellosis exposed or infected animals held within federally approved research facilities.
The Committee supports this proposed amendment. The proposal will remove a potential risk to states of losing their brucellosis Class Free classification if research facilities located in the state maintain a herd of cattle that is infected with brucellosis for the purpose of research. The proposed rule will remove this risk by redefining "herd" as follows: "For the purposes of this part, the term herd does not include animals that are contained within a federally approved research facility."
The Committee is confident in the current federal USDA approval guidelines for agricultural research facilities. These approval guidelines for appropriate biosafety level containment will provide minimal risk to US livestock industries associated with this proposal. We support the recommended guidelines addressing biological security, recordkeeping, identification, and sanitation standards, but recommend these be integrated with the institutional and USDA approval processes for animal care and use and biosafety that are currently in place, rather than creating a new federal approval process. The current animal care and use and biosafety regulations meet the select agent rules that prevent receipt, storage and research on select agents unless the facility is registered and approved. Brucella spp. are classified as select agents, and are addressed under these requirements.
We are pleased to have the opportunity to provide comments on APHIS’s proposed amendment to the brucellosis regulations, and hope that these recommendations are of assistance to the USDA.
Ruth Berkelman, M.D., Chair, Public and Scientific Affairs Board
Michael Doyle, Ph.D., Chair, Committee on Agriculture and Food Microbiology