On October 2, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) announced the release of a new web-based tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. EPA notes that biotechnology products include plants, animals, and microorganisms developed through genetic engineering or the targeted manipulation of genetic information. According to EPA, the new tool provides a starting point for researchers and developers, especially those new to biotechnology product development, to navigate the regulatory requirements for genetically modified microorganisms. EPA states that the tool provides users, through a series of prompts, with information on regulatory requirements for biotechnology products developed using genetically modified microorganisms and the approval process across agencies. As part of the agencies’ commitment to continuous improvement, they will continue to expand the tool’s utility, scope, and user base. The tool includes a feedback function to allow stakeholders to submit feedback directly to the agencies.

As reported in our November 14, 2023, blog item, through a December 2022 request for information (RFI), stakeholders identified regulatory ambiguities, gaps, and inefficiencies within the Coordinated Framework for the Regulation of Biotechnology. Commenters requested greater coordination among the three agencies and more assistance with the regulatory process for biotechnology products. According to EPA, the new tool was created in response to this feedback and is part of a broader EPA, FDA, and USDA plan to modernize the Coordinated Framework.

EPA states that the three agencies are also undertaking other work to address the goals and directives in Executive Order (EO) 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” This includes aligning USDA and EPA data requirements to improve data transferability and reduce duplicative review of biotechnology products. Additionally, USDA recently issued an RFI to explore less burdensome pathways to commercializing genetically modified microbes.