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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...

The House Committee on Science, Space, and Technology will hold a hearing on February 5, 2025, on “The State of U.S. Science and Technology: Ensuring U.S. Global Leadership.” According to the Hearing Charter, the purpose of the hearing is “to assess the current condition of the United States’s science and technology enterprise and its vital role in the global innovation race.” By examining public and private investments in the United States, the Committee will also...

The European Commission (EC) announced on January 29, 2025, that it launched a Biotech and Biomanufacturing Hub to support companies — particularly start-ups and small and medium-sized enterprises (SME) — in bringing innovative products to the European Union (EU) market and increase their competitiveness. According to the EC, the Hub will also help companies identify available support at the EU level and how to access this support to help them expand and grow. The EC...

Bergeson & Campbell, P.C. (B&C®), its global consulting affiliate The Acta Group (Acta®), and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to share with you our 2025 Forecast. For all the reasons you might imagine, our seasoned team was especially challenged this year in speculating on what to expect in 2025 regarding global industrial, agricultural, and biocidal chemical regulatory and policy initiatives. Given the European Parliamentary...

The Congressional Research Service (CRS) posted a November 30, 2024, update to its report entitled “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated Framework for Regulation of Biotechnology, which coordinates how the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) regulate biotechnology products to ensure their safety. Over time, the...

On November 15, 2024, the White House Office of Science and Technology Policy (OSTP) released a report by the Biomanufacturing Interagency Working Group entitled “Building a Vibrant Domestic Biomanufacturing Ecosystem.” The Working Group includes representatives from the U.S. Department of Defense, U.S. Department of Energy, U.S. Department of Commerce, U.S. Department of Agriculture, U.S. Department of Health and Human Services, National Science Foundation, U.S. Department of State, the...

The White House Office of Science and Technology Policy (OSTP) published a fact sheet on June 25, 2024, on the Biden-⁠Harris Administration’s actions to advance American biotechnology and biomanufacturing. According to the fact sheet, on June 25, 2024, the White House, members of the National Bioeconomy Board, and the U.S. Departments of Energy (DOE), Defense (DOD), and Agriculture (USDA) convened major biotechnology and biomanufacturing companies, nonprofits, and other stakeholders to...

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology (the Plan) provides a roadmap for actions the agencies will take,...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 22, 2024, that it has prepared a draft environmental impact statement (EIS) and draft plant pest risk assessment (PPRA) evaluating the potential environmental impacts and plant pest risk that may result from the approval of a petition for nonregulated status for maize developed using genetic engineering for dicamba, glufosinate, quizalofop, and 2,4-dichlorophenoxyacetic acid...

The Congressional Research Service (CRS) published a report on March 22, 2024, on “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated Framework for Regulation of Biotechnology, which coordinates how the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) regulate biotechnology products to ensure their safety. Over time, the agencies have been...