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March 25, 2016

Sign Up For The Third And Final Public Meeting On Modernizing The Regulatory System For Biotechnolo


On July 2, 2015, 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 jointly issued Modernizing the Regulatory System for Biotechnology Products, a memorandum directing the U.S. Environmental Protection Agency (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), develop a long-term strategy to ensure that the federal biotechnology regulatory system can handle future biotechnology products, and commission an external analysis of the future landscape of biotechnology products. Three public meetings were planned, two of which have already occurred, to discuss the memorandum with the public and invite oral and written comments from interested parties. The third public meeting will be held on March 30, 2016, at the University of California's Davis Conference Center in Davis, California, to review progress made on efforts to modernize the regulatory system. Those planning to attend online or in person should register in advance and prepare by reviewing the two draft documents that will be discussed during the meeting: (1) Table of the oversight of biotechnology products and relevant coordination across EPA, FDA, and USDA; and (2) Regulation of Biotechnology Products — Clarifying Roles and Responsibilities through Hypothetical Case Studies.

The Biobased and Renewable Products Advocacy Group (BRAG®) has been following these meetings and recently published a summary of the documents discussed at the second public meeting, Biotechnology: Case Studies of Hypothetical, Genetically Engineered Organisms Are Discussed at Second Meeting on Modernizing the Regulatory System for Biotechnology Products to Illustrate Agencies' Roles and Responsibilities. These efforts to modernize the Coordinated Framework are essential to the future of the biotechnology industry. Stakeholders should participate actively in this final meeting to share their experiences using the current regulatory system with the Administration while emphasizing what parts of the Coordinated Framework are successful and what could be improved.