White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

(Bergeson & Campbell) On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” More information is available in the White House blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System.

The 2017 Update is intended to clarify the current roles and responsibilities of the primary agencies involved in the regulation of biotechnology products. The accompanying National Strategy, published in September 2016, identifies future steps intended to ensure the regulatory system addresses novel types of products developed through advances in science and technology appropriately. READ MORE