In response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) have developed a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology.
The agencies have identified five major areas of biotechnology product regulation where these actions will focus:
- Modified plants
- Modified animals
- Modified microorganisms
- Human drugs, biologics, and medical devices
- Cross-cutting issues
EPA, the FDA and USDA intend to implement the following joint efforts:
- clarify and streamline regulatory oversight for genetically engineered (GE) plants, animals and microorganisms;
- update and expand their information sharing through an MOU to improve and broaden communication and coordination of oversight of modified microbes; and
- undertake a pilot project focused on modified microbes to explore and consider the feasibility and costs of developing a web-based tool that informs developers about which agency may regulate a given product category.
The Federal Government established the Coordinated Framework for the Regulation of Biotechnology in 1986 and most recently updated it in 2017. The Agencies will continue to engage with all interested stakeholders as they implement the plan.
Visit the Unified Website for Biotechnology Regulation for additional information.
USDA news release
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