All Knowledge & Insights By Date

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...

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 Council of the European Union (EU) announced on March 14, 2025, that the Committee of the Permanent Representatives of the Governments of the Member States to the EU (Coreper) endorsed the Council’s negotiating mandate on the regulation on plants obtained by new genomic techniques (NGT) and their food and feed. The regulation proposed by the European Commission (EC) would create two ways for NGT plants to be placed on the market: Category 1 NGT plants: Could occur naturally or through...

The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on February 7, 2025, that its 2025 Project Peer Review, initially planned for April 22-25, 2025, is postponed until a future, yet to be determined, date. According to BETO, approximately 200 projects in its research, development, and demonstration portfolio “will be presented to the public and systematically reviewed by experts from industry, academia, and federal agencies.” BETO notes that the 2025...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on February 27, 2025, that it will begin to accept petitions for nonregulated status according to APHIS biotechnology regulations at 7 C.F.R. Part 340 (2019) on March 3, 2025. APHIS notes that its biotechnology regulations enable developers to petition for a determination that an “article” is not regulated. The petition process applies only to plants that meet the regulatory definition...

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 have the opportunity...

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 states that the Biotech...

The U.S. Department of Agriculture (USDA) announced on December 20, 2024, that the United States prevailed in its dispute under the United States-Mexico-Canada Agreement (USMCA) challenging certain Mexican biotechnology measures concerning genetically engineered (GE) corn. Under a February 2023 presidential decree, Mexico banned immediately the use of GE corn in dough and tortillas and instructed government agencies to eliminate gradually the use of GE corn for other food uses and in animal...

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 National Security Commission on Emerging Biotechnology announced on December 18, 2024, that the fiscal year 2025 National Defense Authorization Act includes “a suite of recommendations designed to galvanize action on biotechnology” for the U.S. Department of Defense (DOD). According to the Commission, the bill includes new authorities and requirements -- derived from its May 2024 proposals -- that will position DOD and the intelligence community (IC) to maximize the benefits of...

As reported in our December 5, 2024, blog item, on December 4, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it acknowledges the U.S. District Court for the Northern District of California’s December 2, 2024, ruling prospectively vacating USDA’s May 2020 final rule for organisms developed using genetic engineering. National Family Farm Coalition, et al. v. Vilsack (No. 3:21-cv-05695-JD). As reported in our May 18, 2020,...

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 December 4, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it acknowledges the U.S. District Court for the Northern District of California’s December 2, 2024, ruling prospectively vacating USDA’s May 2020 final rule for organisms developed using genetic engineering. National Family Farm Coalition, et al. v. Vilsack (No. 3:21-cv-05695-JD). As reported in our May 18, 2020, memorandum, the final Sustainable, Ecological,...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on November 13, 2024, that it added modifications a plant may contain and qualify for exemption from regulations governing movement of organisms modified or produced using genetic engineering because the modifications are achievable through conventional breeding. 89 Fed. Reg. 89569. As reported in our November 16, 2023, blog item, APHIS had proposed five types of modifications: Plants that...

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...

On October 28, 2024, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced that a new NASEM initiative, the International Bioeconomy Forum, will launch in early 2025. According to NASEM, its International Bioeconomy Roundtable and the Association of Biotechnology Led Enterprises (ABLE) met on September 13, 2024, during the Global Bio-India 2024 conference in New Delhi, India, to discuss the scope of the International Bioeconomy Forum. NASEM states that the forum will...

On November 6, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced the completion of the final version of the Guide to Submitting Data for Reports and Notices in APHIS eFile and the Response to Comments: Guide to Submitting Data for Reports and Notices in APHIS eFile. In October 2023, to clarify and streamline its biotechnology regulations further, BRS published for comment a draft guide to...

The International Bar Association (IBA) Agriculture and Food Section (AFS) is pleased to present a webinar, “Cultivated meat: opportunities and challenges,” on November 14, 2024, spotlighting the considerable opportunities cultivated meat offers. Cultivated meat, also known as lab-grown or cell-based meat, introduces a groundbreaking approach to meat production, poised to tackle the challenges of traditional animal agriculture. During this event, presenters Maarten Van der Heijden, Food and...

In October 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) reviewed the following plants modified using genetic engineering to determine whether they posed an increased plant pest risk relative to non-modified comparators: SoilCea, sweet orange with improved resistance to citrus greening; Pioneer, corn with fungal disease resistance; GreenLab, Inc., modified corn to produce an enzyme that degrades cellulose and for herbicide resistance to...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual stakeholder meeting on November 14, 2024. The meeting will take place in person at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland, with an option for virtual attendance. The meeting agenda includes the following items: Program Highlights: An overview of BRS’ fiscal year (FY) 2024 successes; Regulatory Status Review...

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 U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced on September 12, 2024, the availability of the following updated resources to help developers more efficiently prepare and submit APHIS BRS permit applications: Permit User Guide -- Implements stakeholder feedback to clarify information requirements and how BRS uses the information when reviewing permit applications, provides tips on efficiently...

TSCA/FIFRA/TRI EPA Updates Safer Choice And DfE Standard: The U.S. Environmental Protection Agency (EPA) announced on August 8, 2024, the availability of the final updated Safer Choice and Design for the Environment (DfE) Standard (the Standard). 89 Fed. Reg. 64915. According to EPA, the update includes a name change to the title of the Standard, a revision to the packaging criteria, a new certification for cleaning service providers, a new provision allowing for preterm partnership termination...

On August 27, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it recently reviewed the following plants modified using genetic engineering to determine whether they posed an increased plant pest risk relative to non-modified comparators: University of Florida, two submissions, a sweet orange and a grapefruit with disease tolerance to citrus greening, also called Huanglongbing (HLB); and Bioceres Crop Solutions, wheat with...

On August 2, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) announced a new flexibility for BRS importation permits in APHIS eFile. APHIS states that it has implemented a new flexibility allowing permit holders to reuse import labels. According to APHIS, permit holders no longer need to request additional labels if they have used all the import labels received with their permit. APHIS notes that...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual stakeholder meeting on November 14, 2024. The meeting will take place in person at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland, with an option for virtual attendance. The meeting will include updates on: Highlights from fiscal year 2024; Priorities for fiscal year 2025; and Business process improvements. BRS requests...

On July 5, 2024, the U.S. Department of Agriculture (USDA) released its spring 2024 Unified Agenda, which includes the following items regarding biobased products and biotechnology: Higher Blends Infrastructure Incentive Program: The Higher Blends Infrastructure Program is designed to increase the sales and use of higher blends of ethanol and biodiesel by expanding the infrastructure for renewable fuels derived from U.S. agricultural products. The Rural Business-Cooperative Service (RBCS)...

On June 27, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it recently reviewed the following plants modified using genetic engineering to determine whether they posed an increased plant pest risk relative to non-modified comparators: Plants modified for altered product quality: CoverCress, two pennycresses; Hjelle Advisors, rice; and Toolgen, soybean; Plant modified for increased yield: Inari, two soybeans; Plant modified...

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...

TSCA/FIFRA/TRI                                                                                                                           EPA Announces New Resource Portal And Reporting Tool Improvements Before CDR Reporting Begins On June 1, 2024: On May 16, 2024, the U.S. Environmental Protection Agency (EPA) announced the creation of CDR GuideME, a new resource portal, and...