New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape

On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for Biotechnology Regulation[1] for companies that develop microbial biotechnology products.[2] The purpose of the tool is to help developers fulfill the regulatory requirements necessary to work with genetically modified microorganisms.[3] The tool defines “genetic modification” as any technique that uses recombinant, synthesized, or amplified nucleic acids to modify or create a genome. “Microorganisms” include prokaryotes (e.g., bacteria and archaea), protists (e.g., amoebas), fungi (e.g., yeast, mold, mushrooms), green and red algae, and viruses or virus-like particles. Through a series of prompts, the tool provides users with information on regulatory requirements and the approval process across agencies. A built-in feedback function allows stakeholders to submit feedback directly to the agencies, which have expressed a commitment to continuing to improve the tool and expand its utility, scope and user base.

First published in 1986, the Coordinated Framework for the Regulation of Biotechnology describes federal policy for ensuring the safe use of biotechnology products, which include plants, animals, and microorganisms developed through genetic engineering, and how the EPA, FDA, and USDA share responsibility for their regulation.[4] This new tool is not only responsive to the goals of these agencies to modernize the Coordinated Framework, but also to the goals of the President’s Executive Order 14081[5] to ensure public confidence in the biotechnology regulatory system and improve its transparency, predictability, coordination, and efficiency. Other work underway to address these goals include aligning USDA and EPA data requirements to improve data transferability and reduce duplicative review of biotechnology products. Additionally, USDA recently issued a request for information to explore less burdensome pathways to commercializing genetically modified microbes.[6]

Editor: Brenden S. Gingrich, Ph.D.