Share

Final Version of the Updated Coordinated Framework for the Regulation of Biotechnology Available

January 23, 2017

The Obama Administration announced in early January the publication of the final version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). (A White House blog post unveiling the final version can be found here.)  The update began in 2015 when the Executive Office of the President (EOP) issued 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. The memorandum also established a Biotechnology Working Group, which developed the 2017 Updated Coordinated Framework. (See the PackagingLaw.com article, Coordinated Framework for the Regulation of Biotechnology in the U.S. to be Updated, for more information on the 2015 memorandum.) The Coordinated Framework was first published in 1986 and updated in 1992.

The 2017 updated Coordinated Framework describes the authorities and responsibilities of EPA, FDA, and USDA with respect to biotechnology products (organized by agency and then by statute) and includes a section on the mechanisms currently in place to enable communication and sharing of information between the three agencies. The Biotechnology Working Group also published a National Strategy for Modernizing the Regulatory System for Biotechnology Products (Strategy) in September 2016, which identifies future steps that should be taken to ensure the regulatory system addresses novel types of products developed through advances in science and technology appropriately.

One of the reasons for the need to modernize the biotechnology regulatory system was pointed out by the Biotechnology Working Group in the 2017 Updated Framework, “While the current regulatory system for the products of biotechnology effectively protects health and the environment, in some cases unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes have arisen.”

The Biotechnology Working Group will continue to monitor developments in this area and will produce annual reports for at least five years on specific steps that agencies are taking to implement recommendations in Strategy and any other steps that the agencies are taking to improve the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products.