Michael S. Regan 16th Administrator, United States Environmental Protection Agency | Official Website
On May 8, 2024, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) announced a joint plan to update their regulations and oversight mechanisms for biotechnology products. This move comes in response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”
The new plan is designed to ensure public confidence in the biotechnology regulatory system by improving its transparency, predictability, coordination and efficiency. It was developed through engagement with developers and stakeholders as well as horizon scanning for novel biotechnology products.
The agencies have identified five major areas of focus: modified plants, modified animals, modified microorganisms, human drugs, biologics and medical devices, and cross-cutting issues.
The EPA, FDA and USDA intend to implement joint efforts such as clarifying and streamlining regulatory oversight for genetically engineered plants, animals and microorganisms; updating and expanding their information sharing through an MOU to improve communication and coordination of oversight of modified microbes; and undertaking a pilot project focused on modified microbes.
The Coordinated Framework for the Regulation of Biotechnology was established by the federal government in 1986 and last updated in 2017. It outlines federal regulatory policy for ensuring the safety of biotechnology products. The Executive Order directs these three agencies to improve how they implement this framework.
In response to the Executive Order, the three regulatory agencies issued a Request for Information to solicit public input on regulatory ambiguities or inefficiencies in the Coordinated Framework. They received 88 distinct public comments from various stakeholders including biotechnology developers, producers, manufacturers, non-governmental organizations and academia.
For more information on modernizing the regulatory system for biotechnology products and Executive Order 14081 visit the Unified Website for Biotechnology Regulation.
