On March 14, 2025, President Trump signed Executive Order (EO) 14236, rescinding 19 executive actions, including former President Biden’s September 2022 EO 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” 90 Fed. Reg. 13037. According to the White House’s March 14, 2025, fact sheet, EO 14081 “funneled Federal resources into radical biotech and biomanufacturing initiatives under the guise of environmental policy.” As reported in our September 13, 2022, blog item, Biden’s EO created a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. EO 14081 called for the Secretary of Agriculture, the Administrator of the U.S. Environmental Protection Agency (EPA), and the Commissioner of Food and Drugs to identify areas of ambiguity, gaps, or uncertainties in the January 2017 Update to the Coordinated Framework for the Regulation of Biotechnology or in the policy changes made pursuant to the June 2019 EO 13874, “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.” To update the Coordinated Framework, the U.S. Department of Agriculture (USDA), EPA, and the U.S. Food and Drug Administration (FDA) prepared The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology, an ambitious plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. While the USDA, EPA, and FDA intended to release an updated Coordinated Framework in December 2024, the agencies did not do so. More information on the 2017 Update to the Coordinated Framework is available in our January 9, 2017, memorandum. More information on the 2024 Plan for Regulatory Reform is available in our May 16, 2024, memorandum.
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