1 Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology A. Executive Summary While the current Federal regulatory system for biotechnology products effectively protects health and the environment, advances in science and technology have altered the product landscape rapidly. In addition, the complexity of the current regulatory system with regard to biotechnology products can make it difficult for the public to understand how the safety of biotechnology products is evaluated and create challenges for small and mid-sized businesses navigating the regulatory process for these products. To address these challenges, on July 2, 2015, the Executive Office of the President (EOP) issued a memorandum 1 (July 2015 EOP Memorandum) directing the primary agencies that regulate the products of biotechnology—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) by clarifying current roles and responsibilities, to develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and to commission an expert analysis of the future landscape of biotechnology products to support these efforts. The goal of this work is to increase public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness. This Update to the Coordinated Framework is a sequel to the 1986 Coordinated Framework for the Regulation of Biotechnology (the 1986 Coordinated Framework) and the 1992 Update to the Coordinated Framework and is intended to clarify the current roles and responsibilities of the primary agencies involved in the regulation of biotechnology products. The accompanying National Strategy for Modernizing the Regulatory System for Biotechnology Products (Strategy), which was published in September 2016, identifies future steps to ensure the regulatory system addresses novel types of products developed through advances in science and technology appropriately. The Update to the Coordinated Framework and the Strategy were developed by the Biotechnology Working Group (Biotechnology WG) established by the July 2015 EOP Memorandum under the auspices of the Emerging Technologies Interagency Policy Coordination Committee. The July 2015 EOP Memorandum listed the following four tasks to be undertaken by the Biotechnology WG: 1. Clarify which biotechnology product areas are within the authority and responsibility of each agency; 1 Memorandum for Heads of Food and Drug Administration, Environmental Protection Agency, and Department of Agriculture Regarding Modernizing the Regulatory System for Biotechnology Products, Executive Office of the President, July 2, 2015 (July 2015 EOP Memorandum). Available online at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_ memo_final.pdf.
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