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USDA, FDA Sign MOU on Animal Biotechnology Regulation January 20, 2021
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.
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 alte
FDA Commissioner Hahn says his agency does not support the MOU allowing USDA oversight of animal biotechnology.
In action Jan. 19, Secretary of Agriculture Sonny Perdue signed a Memorandum of Understanding with the Assistant Secretary for Health and Head of the Public Health Service Admiral Brett Giroir, M.D., establishing a regulatory environment at USDA for agricultural animal biotechnology innovation. However, Food and Drug Administration Commissioner Dr. Stephen Hahn says despite the MOU, FDA will not hand over oversight to USDA.
“USDA and FDA have a long history of delineating the review of products with overlapping jurisdictional authority between the two agencies to promote regulatory clarity and reduce duplicative review,” USDA states. However, Hahn continues to say human health oversight should remain at FDA. The back and forth between USDA and FDA culminates over a year of discussion between Perdue’s comments and actions at USDA and FDA’s staunch desire to s