The United States Department of Agriculture (USDA) and US Department of Health and Human Services signed the Memorandum of Understanding (MOU) finalizing the joint roles of the USDA and the Food and Drug Administration (FDA) in regulating products derived from animal biotechnology.
Agriculture Secretary Sonny Perdue stated the effort “clears a path to bring our regulatory framework into the 21st century.” The MOU outlines responsibilities concerning the regulation of certain animals developed using genetic engineering intended for agricultural purposes. The MOU complements USDA’s issuance of an Advanced Notice of Proposed Rulemaking on the Movement of Animals Modified or Developed by Genetic Engineering on December 28, 2020.
The MOU was signed on January 13, 2021, and complements USDA’s issuance of an Advanced Notice Proposed Rulemaking (ANPR) on the Movement of Animals Modified or Developed by Genetic Engineering released three weeks prior. The MOU covers the responsibilities of the regulation of “amenable species” intended for agricultural purposes developed using genetic engineering. In it, USDA and FDA will both continue to implement existing laws and Acts when regulating the products. However, new roles are also highlighted such as USDA and FDA working together on a communication plan to explain FDA’s role in overseeing animal genetic alterations using a streamlined, risk-based approach. USDA is also set to consult FDA when establishing a review process for the product derived by animal biotechnology.
The USDA explained in a press release that the MOU states that USDA will provide oversight of animals modified or developed through genetic engineering for human food from pre-market reviews to post-market food safety monitoring, while FDA will continue its review of intentional genomic alterations intended not just for agricultural use but for biopharma and non-heritable genetic alterations as well. The MOU intends for the transition of the FDA’s pre-existing animal biotechnology regulatory responsibilities to USDA.