The document constitutes a formal comment submitted by the Association of American Universities (AAU), the Association of Public and Land-grant Universities (APLU), and the Council on Governmental Relations (COGR) to the U.S. Department of Agriculture (USDA) in response to a federal request for input on regulatory reform, particularly regarding USDA policies for animal research. The associations acknowledge the necessity of federal oversight to ensure the welfare of animals used in research but emphasize that the current regulatory framework results in substantial administrative burdens due to redundant, outdated, or ineffective requirements, which do not necessarily yield improvements in animal welfare or research efficiency.
Drawing on the findings of a collaborative workshop and the broader mandate of the 21st Century Cures Act, the submission provides targeted recommendations to streamline animal research oversight while maintaining high standards of animal care. Key proposals include aligning review intervals with existing Public Health Service policies, updating USDA Animal Care Policies to facilitate scientifically justified research practices, clarifying literature search requirements, and allowing for institutional discretion in facility evaluations. The document also advocates for consideration of external accreditation in USDA inspections, the formation of an expert advisory group to guide regulatory reform and ongoing reviews, and the implementation of risk-based protocol review processes similar to those for human subjects research. The associations argue that these recommendations would reduce unnecessary administrative demands, support robust animal welfare, and enhance the effectiveness of federally funded research. The letter concludes with background information on the signatory organizations, underscoring their expertise and commitment to advancing research while ensuring responsible regulatory practices.
