March 17, 2016

Agencies Convene Second Meeting On Modernizing Regulatory System For Biotechnology Products

From: The National Law Review


On March 2, 2016, EPA and other federal agencies announced that the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products” would be held March 9, 2016, in Dallas, Texas. 81 Fed. Reg. 10858. According to EPA, the March 9, 2016, meeting was convened to solicit comment on the current federal roles and responsibilities regarding biotechnology products. The July 2, 2015, memorandum was jointly issued by the Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality, and directs EPA, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology, and describes the federal regulatory policy intended to ensure the safety of biotechnology products. The Administration’s initiative has three key components. First, the Administration will update the Coordinated Framework, after accepting public comment, to clarify the “roles and responsibilities” of the federal agencies that now regulate the products of biotechnology: EPA, FDA, and USDA. . . .

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