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The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on July 8, 2025, that it has received a petition from Bayer CropScience seeking a determination of nonregulated status for MON 95275 maize (corn) that has been developed using genetic engineering to produce two insecticidal proteins and a double-stranded RNA transcript to provide protection from feeding damage caused by targeted coleopteran (corn rootworm) insect pests. 90 Fed. Reg. 30035....

On July 1, 2025, the European Chemical Industry Council (Cefic) announced a new position paper and five-point action plan that will “help deliver a [European Union (EU)] Bioeconomy Strategy that supports the scale-up of bio-based chemistry, biomanufacturing, and achieve industrial transformation while adhering to planetary boundaries.” According to Cefic, the European Commission (EC) should mainstream revision of the EU Bioeconomy Strategy into all forthcoming legislations. The revision...

The U.S. Department of Agriculture (USDA) announced on August 1, 2025, the opening of a 30-day public comment period for stakeholders to provide feedback on USDA’s reorganization plan, as outlined in the July 24, 2025, memorandum issued by U.S. Secretary of Agriculture Brooke L. Rollins. According to the press release, the reorganization proposal reflects President Trump’s commitment to relocate federal agencies beyond the national capital region, reduce bureaucracy, and strengthen USDA’s...

The U.S. Environmental Protection Agency (EPA) announced on July 23, 2025, that it seeks nominations of scientific and technical experts to be considered as ad hoc reviewers in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel’s (SAP) review of EPA’s white paper on genetically engineered (GE) female mosquitoes for mosquito control. 90 Fed. Reg. 34864. EPA states that it will solicit review and input from the FIFRA SAP on methodologies for determining...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on July 9, 2025, that it is updating its practices for reviewing petitions seeking a determination of nonregulated status for organisms altered or produced through genetic engineering (modified organisms) under 7 C.F.R. Part 340. According to APHIS, it is making these updates to ensure its petition process aligns with recent developments related to the National Environmental Policy Act...

On June 6, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it has prepared a revised draft environmental impact statement (EIS) and revised 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 blight-tolerant American chestnut (Castanea dentata) from the State University of New York College of...

On June 16, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a final rule making technical amendments to the Code of Federal Regulations (C.F.R.) to conform the C.F.R. to the U.S. District Court for the Northern District of California’s vacatur of USDA’s May 2020 final rule for organisms developed using genetic engineering. 90 Fed. Reg. 25123. The rule was effective June 16, 2025. As reported in our May 18, 2020, memorandum, the...

The National Security Commission on Emerging Biotechnology (NSCEB) announced on July 1, 2025, that it is gathering input to modernize U.S. biotechnology product regulation and create simpler, faster, science-based pathways to market. According to NSCEB, this input will guide follow-on work to its April 2025 report, which called for streamlining regulation of biotechnology products. NSCEB seeks “concrete, actionable ideas across sectors, including defense, industrial products, food,...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it received a petition from Ishihara Sangyo Kaisha, Limited seeking a determination of nonregulated status for ISK-311NR-4 Phalaenopsis (moth orchid) that has been developed using genetic engineering to produce a blue-purple flower color. 90 Fed. Reg. 23666. According to APHIS, the petition states that the information provided indicates that ISK-311NR-4 Phalaenopsis is unlikely to pose...

On June 26, 2025, Representatives Chrissy Houlahan (D-PA) and Stephanie Bice (R-OK) announced the formation of the BIOTech Caucus. According to Houlahan’s June 26, 2025, press release, the Caucus’ mission “is to advance bipartisan policy solutions to keep the United States at the forefront of global biotechnology leadership, to engage and learn from sector leaders, and to build awareness and bioliteracy among Members of Congress.” Joining Co-Chairs Houlahan and Bice on the BIOTech Caucus...

On July 1, 2025, the National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a workshop session on transformative science and technology for the U.S. Department of Defense (DOD), “Synthetic Biology for Biomanufacturing and Predictable Engineering.” NASEM states that “[a]dvances in biotechnology and biomanufacturing are essential for the United States to maintain global leadership as well as for supporting economic and national security interests.” The workshop session...

On June 13, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that its Biotechnology Regulatory Services (BRS) has launched an updated Pre-Application Questionnaire that will replace the BRS Permitting Assistant in APHIS eFile. According to APHIS, applicants using APHIS eFile will experience: An interface that leads applicants through a series of questions to determine if their application qualifies for a notification or if a permit...

The National Security Commission on Emerging Biotechnology (NSCEB) is holding a roadshow to highlight biotechnology across America, including the companies, academic institutions, industry alliances, workforce development programs, and policy initiatives that are driving the future for this rapidly growing industry. Commissioners intend to continue learning about the work being done while engaging on the key findings and recommendations from NSCEB’s recent report to Congress. The first event...

The European Commission (EC) began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the biotechnology sector in the European Union (EU) while maintaining high safety standards. The new European Biotech Act will aim to ensure that the EU makes the most of the biotechnology revolution for the benefit of society, the environment, and the economy, while making it easier to...

On June 3, 2025, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) began a public comment period on a draft plant pest risk assessment (PPRA) and draft environmental assessment (EA) regarding a petition from Bayer U.S.-Crop Science seeking a determination of nonregulated status for maize (corn) event MON 95379 that was developed “using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran...

On June 5, 2025, the House Science and Technology Subcommittees on Energy and on Research and Technology will hold a joint hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology.” The Subcommittees will hear from the following witnesses: Dr. Drew Endy, Hoover Institution Science and Senior Fellow, Martin Family Fellow in Undergraduate Education for Bioengineering, Stanford University; Ms. Deborah Gracio, Associate Lab Director, National Security Directorate,...

As reported in our April 25, 2025, blog item, the National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation to improve and maintain U.S. global leadership in biotechnology.” On April 9, 2025, Senator Alex Padilla (D-CA), an NSCEB Commissioner, and the other three Congressional Commissioners introduced the bipartisan, bicameral...

The National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation to improve and maintain U.S. global leadership in biotechnology.” After an extensive study that included “more than 1,800 stakeholder consultations, a holistic review of unclassified and classified material, site visits across the United States, and meetings with...

The European Commission (EC) began a public consultation on March 31, 2025, on the upcoming European Union (EU) Bioeconomy Strategy. The EC states in its March 31, 2025, press release that the Strategy “marks a significant step forward in harnessing the opportunities of the bioeconomy to support European businesses and drive progress towards the EU’s environmental, climate and competitiveness objectives.” According to the call for evidence, the Strategy’s main aims include: Ensuring the...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a determination that a modified plant should not be subject to the regulations for the introduction of organisms altered or produced through genetic engineering (modified organisms) that are plant pests or that there is reason to believe are plant pests. On March 6, 2012, APHIS...