White House Office of Science and Technology Policy requests information on the regulation of biotechnology

The White House Office of Science and Technology Policy (OSTP)—in coordination with the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)—announced an information request to identify regulatory ambiguities and gaps in the Coordinated Framework for Regulation of Biotechnology. This request includes case studies and other data, particularly pertaining to new and emerging biotechnology products.

Additional information will help regulatory agencies improve the clarity and efficiency of the regulatory processes for biotechnology products as described in Executive Order 14081, ″Advancing Biomanufacturing and Biotechnology Innovation for a Sustainable, Safe, and Secure Bioeconomy.″

Announced in September 2022, Executive Order 14081 promotes accelerating biotechnology innovation and growing America’s bioeconomy across multiple sectors, including health, agriculture and energy. To further this goal, today’s request seeks information to clarify and streamline regulations in service of a science-based, risk-based, predictable, efficient and transparent regulatory system that supports the safe use of biotechnology products.

Upon publication of the Federal Register notice, public comments will be accepted for 45 days in docket APHIS-2022-0076 at www.regulations.gov. EPA, FDA and USDA will review and consider all comments received on the request.

View the Notice of Request for Information.

Listening Session

OSTP, EPA, FDA and USDA will hold a virtual listening session on Thursday, Jan. 12, from 1 p.m. to 6 p.m. EST. To register, please use the Webinar Registration form. If you are interested in additional listening sessions, please contact Dominique Carter at biotech-regulation@ostp.eop.gov.

To learn how EPA, FDA and USDA will work together to implement the Executive Order, visit the Unified Website for Biotechnology Regulation.