Revisiting the U.S. Coordinated Framework for the Regulation of Biotechnology

Biotechnology regulation in the U.S. is carried out by three federal agencies: the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Coordination between these three agencies and principles outlining a suggested regulatory approach are outlined in the Coordinated Framework for the Regulation of Biotechnology, which has been updated twice since its original publication almost 40 years ago in 1986. Even though the science of biotechnology has advanced dramatically since 1986 and products have emerged that don’t fit within the existing regulatory system, repeated calls for substantive changes have gone largely unanswered.

This paper expands upon recommendations from the National Security Commission for Emerging Biotechnology to improve U.S. biotechnology regulation and coordination between agencies. We call upon Congress to create a National Biotechnology Coordination Office and direct it to create a centralized application submission portal; conduct horizon scanning for future products of biotechnology; streamline regulations for familiar products and exempt low-risk products; and improve organizational structure, staff training, and interagency exchange.