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March 3, 2016

Agencies Convene Second Meeting On Modernizing Regulatory System For Biotechnology Products

The ACTA Group

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. It is hoped that this process will clarify which biotechnology product areas are within the authority and responsibility of each agency, and will better outline how the agencies can work together to regulate products that fall within the respective jurisdictional scope of each agency. Second, the Administration will commission an external, independent analysis of the future landscape of biotechnology products. The Administration has asked that the National Academies of Sciences, Engineering, and Medicine (The Academies) conduct such an analysis. Candidates for inclusion on The Academies’ panel were solicited in January 2016. Third, the Administration will formulate a long-term strategy to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology. This component is essential and holds considerable promise in developing a game plan for achieving success.