In response to U.S. President Joseph Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure U.S. Bioeconomy,” the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) have developed plans to update, streamline, and clarify regulatory and oversight mechanisms for biotechnology products.
Executive Order 14081, issued on September 12, 2022, aims to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors, including health, agriculture, and energy. The Executive Order seeks to support the safe use of biotechnology products by clarifying and streamlining regulations to achieve a predictable, efficient, and transparent regulatory system that is science- and risk-based.
On May 8, 2024, EPA, FDA, and USDA released plans incorporating processes and timelines for implementing regulatory reforms, including identifying guidances and regulations for updating, streamlining, and clarification, and identifying the potential need for new guidance and regulations. The agencies identified five major areas of biotechnology product regulation where these actions will be focused, including genetically modified plants, genetically modified animals, genetically modified microorganisms, human drugs, biological products and medical devices, and cross-cutting issues.
EPA, FDA, and USDA will undertake the following joint efforts:
Clarify and streamline regulatory oversight of genetically modified plants, animals, and microorganisms. Update and expand information sharing through MOUs to improve and expand communication and coordination regarding oversight of modified microorganisms. Conduct a pilot project focused on modified microorganisms to explore and consider the feasibility and cost of developing a web-based tool that informs developers of which agencies can regulate their particular product categories.
For more information about the co-regulatory plan, see the EPA news release.
