On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum directing the primary agencies that regulate the products of biotechnology—the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA).
While the current regulatory system for the products of biotechnology effectively protects health and the environment, in some cases, uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes have imposed unnecessary costs and burdens on small and mid-sized companies and academics.
The new Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has implemented the following tasks:
- Updated the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) by clarifying current roles and responsibilities;
- September 2016: Developed a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and
- 2016 Commissioned an expert analysis of the future landscape of biotechnology products to support this effort.
As instructed in the July 2015 EOP memorandum, for at least five years, starting one year after the release of the Strategy, EPA, FDA, and USDA are expected to produce an annual report on the specific steps the agencies are taking to implement this Strategy. In their first annual report, the agencies may, if appropriate, provide a concrete list of regulatory and other activities and expected timeframes. The agencies will also include in that report any additional actions taken by the agencies to improve the transparency, predictability, and efficiency of biotechnology regulation and the coordination among the regulatory agencies.
American Science Alliance is a politically balanced, evidence-based, science and technology public policy organization that brings you transparency and insight into the federal science and technology funding process. Member benefits through Patreon are our way of providing exclusive, rewarding content to those who are making our work actively possible through pledges.