Biotechnology products include plants, animals, and microorganisms developed through genetic engineering or the targeted manipulation of genetic information. The tool provides a starting point for researchers and developers, especially those new to biotechnology product development, to navigate the regulatory requirements for GMOs.

In 1986, the U.S. government established the Coordinated Framework for the Regulation of Biotechnology, which was most recently updated in 2017. The coordinated framework describes federal policy for ensuring the safe use of biotechnology products, including how FDA, EPA, and USDA share responsibility for regulating those products. For more information specifically about FDA’s regulatory pathways for genetically modified foods, read the October 1, 2024 Food Safety Magazine eDigest feature column about the agency’s latest guidance on foods using ingredients derived from genome-edited plants.

In response to 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. The new tool is in response to this feedback, and part of a broader FDA, EPA, and USDA plan to modernize the coordinated framework.

Through a series of prompts, the new tool provides users with information on regulatory requirements for biotechnology products developed using genetically modified microorganisms and the approval process across agencies.

The tool reflects input from biotechnology organizations of varying sizes that were selected by the Science and Technology Policy Institute to participate in pre-release testing in August 2024. As part of the agencies’ commitment to continuous improvement, they will continue to expand the tool’s utility, scope, and user base. A built-in feedback function allows all stakeholders to submit feedback directly to the agencies.

The three agencies are also undertaking other work to ensure public confidence in the biotechnology regulatory system and increase transparency. 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.