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Two contrasting regulatory decisions by authorities in the United States and Mexico highlight the continued progress toward, and challenges to, the development of science and evidence based regulatory policies applicable to genetically engineered foods. In the United States, the U.S. Department of Agriculture (USDA) announced the issuance of the Record of Decision as the final action completing the National Environmental Policy Act (NEPA) process associated with the 2020 amendments to the 7 C.F.R. Part 340 regulations that govern the interstate movement of certain genetically engineered organisms. The Part 340 amendments updated USDA’s regulations applicable to genetically engineered organisms that are subject to USDA’s regulatory purview to better reflect current scientific understanding of the risks posed by such organisms. Meanwhile, moving in a completely opposite direction, the Government of Mexico continues to lu
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The United States Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA), two of the U.S. Federal agencies responsible for regulation of agricultural biotech recently announced two comment periods related to products under their jurisdiction.
On March 8, USDA announced an extension of the comment period on its Advance Notice of Proposed Rulemaking discussing the possible transition of jurisdiction over certain genetically engineered animals from FDA to USDA. USDA had initially published the ANPRM on December 28, 2020, with a 60-day comment period that ended February 26. I discussed the USDA ANPRM in a Wiley alert that we published when the ANPRM was first announced.