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HHS, USDA sign MOU on animal biotechnology


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 de ....

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FDA, USDA still at odds regarding livestock gene-editing


In public comments earlier this week, the current Food and Drug Administration Commissioner Dr. Stephen Hahn says he would refuse to sign the memorandum of understanding between the FDA and USDA addressing gene-edited livestock shifting oversight to USDA. The statement again reveals the ongoing turf war between the two agencies and likely continued discussion as it moves to President-elect Biden’s administration.
On Monday evening, reports indicated Hahn told Health and Human Services officials that he would refuse to sign a memorandum of understanding transferring regulatory power to USDA citing “concerns about its legality and the potential health repercussions of relaxing oversight of certain genetically altered products,” Politico reports. ....

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