The document is a formal response, jointly 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 United States Department of Agriculture (USDA) regarding its Request for Information on identifying and reducing regulatory burdens. The letter acknowledges the necessity of appropriate regulations to ensure the safety and ethical conduct of research, especially animal research, but highlights mounting administrative workload—citing evidence that researchers spend a significant portion of their time (approximately 42% of available research time) fulfilling regulatory obligations. The organizations provide detailed recommendations to streamline regulation without compromising research quality or animal welfare, in accordance with relevant Executive Orders.
Key suggestions include harmonizing USDA’s protocol review timeline for animal research with the Public Health Service (PHS) by moving from annual to triennial reviews, or restricting annual review requirements to the most ethically sensitive research (Category E), thus reducing redundant administrative effort. They advocate for a risk-based, tiered oversight structure for animal research, similar to frameworks used in human subjects research, and propose that USDA inspections be less frequent—every 2-3 years for compliant institutions—instead of annually. Additionally, the organizations recommend reconsidering the requirement for literature searches as the default method for identifying alternatives to animal models, arguing that such mandates are administratively burdensome and often ineffectual. The letter concludes by expressing willingness to collaborate with the USDA in developing less burdensome yet effective regulatory approaches.
