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White House Releases Update to BioTech Coordinated Framework

Sep 21, 2016

The White House last week released a long-anticipated Update to the Coordinated Framework for the Regulation of Biotechnology. The Coordinated Framework, which was established in 1986 and updated in 1992, outlines responsibility for regulating genetically engineered crops, also known as genetically modified organisms (GMOs), and other biotechnology products among three agencies: the Environmental Protection Agency, the Food and Drug Administration and the U.S. Department of Agriculture.

The Update to the Coordinated Framework presents a comprehensive summary that clarifies the current roles and responsibilities of the EPA, FDA and USDA in the regulatory process. To clarify these roles, the update includes graphic representations outlining the agencies roles, case studies that demonstrate how to navigate the regulatory framework and summary tables describing the array of biotechnology products and how they are regulated by the agencies.

The White House believes the Update to the Coordinated Framework will give the public confidence that biotechnology products are appropriately reviewed for safety before reaching the market. The agencies will be accepting comment on the update in the coming weeks after it appears in the Federal Register.

National Strategy to Change Biotechnology Regulations

In conjunction with the Coordinated Framework, the agencies released the National Strategy for Modernizing the Regulatory System for Biotechnology Products. This document sets forth a vision for ensuring that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology. The National Strategy seeks to balance supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.

The National Strategy highlights existing and new activities undertaken by each of the agencies to ensure the safety of future products of biotechnology. The document also includes a vision for updates to the regulatory structure and agency roles to address new products. These decisions will be informed by a study the agencies commissioned from the National Academy of Sciences titled “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.”

Member with questions can contact Emily Lyons, IDFA director of regulatory affairs and counsel, at

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