All Knowledge & Insights By Date

On May 21, 2026, Representatives April McClain Delaney (D-MD) and Jay Obernolte (R-CA) introduced the Standards and Calibration for American Leadership in Engineering Biology (SCALE Biology) Act (H.R. 8981). According to McClain Delaney’s May 22, 2026, press release, the bipartisan legislation would establish a new federal program dedicated to biometrology, “an advanced science critical to U.S. leadership in emerging biotechnology, including healthcare innovation, agricultural research,...

As reported in our March 5, 2026, blog item, the U.S. International Trade Commission (USITC) is undertaking a factfinding investigation to examine Chinese state support and pricing practices in the biotechnology sector and assess how these practices may be affecting the market share and competitiveness of the U.S. industry. USITC is instituting its investigation, “Impact on U.S. Industry of China’s State Support and Pricing Practices in the Biotechnology Sector” (Inv. No. 332-610),...

On May 5, 2025, a coalition of U.S. biotechnology companies announced the launch of the American Biotech Innovation Alliance (ABIA). ABIA states that it will “focus on a shared objective: to sustain and strengthen America’s leadership in biotech innovation.” ABIA will work to develop a new roadmap to support the biotech ecosystem. According to ABIA, leaders from across the U.S. biotech industry and research sectors will develop a national innovation strategy outlining the policy,...

On April 27, 2026, the Organisation for Economic Co-operation and Development (OECD) published a blog item entitled “Biotech start-ups in Europe: Why does the EU lag behind competitors and what can policymakers do about it? ” According to the item, evidence shows that Europe still lags competitors in biotech start-up creation, patenting, and venture capital funding. OECD’s blog item “unpacks the gap and explores how agile regulation and smarter financing tools” can help European Union...

The U.S. Department of Agriculture (USDA) announced on April 7, 2026, the creation of the USDA Guidance Portal, an online searchable, indexed database that contains guidance documents issued by USDA and its agencies that are currently in effect. Users can search all guidance documents in the library, or filter documents by date, agency (such as the Animal Plant Health Inspection Service (APHIS)), or topic (including biotechnology). USDA notes that the guidance documents lack the force and effect...

The U.S. International Trade Commission (USITC) announced on February 26, 2026, that it is undertaking a factfinding investigation to examine Chinese state support and pricing practices in the biotechnology sector and assess how these practices may be affecting the market share and competitiveness of the U.S. industry. USITC states that it is instituting this investigation, “Impact on U.S. Industry of China’s State Support and Pricing Practices in the Biotechnology Sector” (Inv. No....

On January 29, 2026, Senator Tom Cotton (R-AR) introduced the Biosecurity Modernization and Innovation Act of 2026 (S. 3741) to establish a federal biosecurity framework. According to Cotton’s February 4, 2026, press release, the bill “will require gene synthesis providers screen their orders and customers for bad actors or dangerous pathogens, and will ensure that the U.S. government adopts a flexible and agile approach to biosecurity that will ensure American leadership in biosecurity.”...

On February 4, 2026, the National Security Commission on Emerging Biotechnology (NSCEB) announced the release of a fact sheet on biotechnology solutions for critical minerals. NSCEB notes that the United States is overly reliant on China for critical minerals. According to NSCEB, biotechnology “creates new paths to reduce our reliance on China by unlocking new sources of critical minerals right here in the United States.” NSCEB states that the recently-announced Project Vault and other...

The Organisation for Economic Co-operation and Development (OECD) posted a working paper on January 30, 2026, entitled A comparison of the innovation and regulatory environments for biotechnology and biosolutions across the European Union and the United States. According to the authors, the working paper “strengthens the evidence base for biotechnology policymaking by examining two critical dimensions: innovation-enabling conditions and regulatory practices.” Focusing on the European Union...

The National Security Commission on Emerging Biotechnology (NSCEB) has published a January 2026 discussion paper entitled “Creating Clear Regulatory Pathways for Biotechnology.” According to the paper, biotechnology regulations in the United States are complex, resulting in a slow process, while regulations in China and other countries allow developers to move ahead more quickly. The paper notes that the regulatory system in the United States is “built on laws that predate biotechnology,...

Download a PDF of the Forecast 2026. 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 Forecast 2026. Our distinguished global team of chemical experts worked hard to summarize our collective best guess on what to expect in the New Year regarding global industrial, agricultural, and biocidal chemical regulatory and policy...

On December 15, 2025, the European Commission (EC) announced a legislative package that includes a proposal for a regulation to establish measures to strengthen the European Union’s (EU) biotechnology and biomanufacturing sectors (Biotech Act). The questions and answers (Q&A) on the Biotech Act note that the proposal is focused on health biotech, “although it also includes provisions on food and feed.” According to the Q&A, the Biotech Act would amend specific parts of EU health...

On November 23, 2025, the Organisation for Economic Co-operation and Development (OECD) published a policy brief entitled “Boosting biotechnology innovation through agile regulation and finance instruments.” The policy brief explores the investment and regulatory policy landscapes in the European Union (EU) and the United States, “highlighting shared challenges and lessons that can help accelerate sustainable innovation and strengthen participation in the global bioeconomy.” The policy...

Ponder the following existential question: Who does their job less effectively? Members of Congress, or employees of federal agencies? Let’s examine the U.S. Environmental Protection Agency (EPA) employees versus those responsible for legislating environmental laws. Congress has not been able to reauthorize environmental statutes for years, with some (most) needing significant attention. EPA relies on 1990 Clean Air Act amendments to sort out air pollution issues and address climate change...

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 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...

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...

On February 7, 2024, the Library of Congress posted an article entitled “South Korea: Act to Promote Green Bio Industry Published.” According to the article, South Korea published the Act on Promoting the Green Bio Industry (Green Bio Act) on January 2, 2024. The Green Bio Act, which will enter into force on January 3, 2025, “aims to promote the application of biotechnology to agricultural bioresources and increase the added value of agriculture, develop the green bio industry, and realize...

The Law Library of Congress published a November 2023 report entitled Selected Issues in Biotechnology Regulation: Australia, Belgium, Brazil, Canada, China, England, European Union, Germany, India, Japan, Mexico, New Zealand, Singapore, South Africa, South Korea, Taiwan that provides an overview of the main statutes and policies governing selected issues on the development of biotechnology products, particularly those derived from genetically modified organisms (GMO) and genetic engineering....

On November 13, 2023, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) posted the following documents on the Unified Website for Biotechnology Regulation: Report on Stakeholder Outreach Related to Ambiguities, Gaps, Uncertainties in Regulation of Biotechnology Under the Coordinated Framework (Report on Stakeholder Outreach) (Mar. 11, 2023); and The Coordinated Framework for the Regulation of Biotechnology:...

The European Commission (EC) announced on October 3, 2023, that it adopted a Recommendation on critical technology areas for the European Union’s (EU) economic security, for further risk assessment with EU member states. According to the EC, the Recommendation relates to the assessment of technology risk and technology leakage. The EC states that the risk assessment “will be objective in character, and neither its results nor any follow-up measures can be anticipated at this stage.” In the...

By Lynn L. Bergeson and Carla N. Hutton   The July 2023 issue of the Organization for Economic Cooperation and Development’s (OECD) Chemical Safety and Biosafety Progress Report includes a summary of the April 2023 meeting of the Party on the Harmonization of Regulatory Oversight in Biotechnology (WP-HROB). During the meeting, WP-HROB agreed on next steps for preparing several consensus documents: “Environmental Considerations for Risk/Safety Assessment for the Release of...

By Lynn L. Bergeson and Carla N. Hutton   On June 27, 2023, the Office of Science and Technology Policy (OSTP) announced the release of a new action plan intended to “rapidly and equitably expand biotechnology and biomanufacturing education and job training programs in the United States.” According to OSTP, biomanufacturing “is a critical aspect of advanced manufacturing that can drive new, sustainable alternatives across industries” and “can unlock new...

By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S. On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal...

By Lynn L. Bergeson and Carla N. Hutton   On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to: Protect agriculture from plant and animal...

By Lynn L. Bergeson and Carla N. Hutton   The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a...

By Lynn L. Bergeson and Carla N. Hutton   As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these...

By Lynn L. Bergeson and Carla N. Hutton As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. The report includes five sections, each presenting goals that highlight what could be possible with the power of biology. The goals set ambitious national targets for the next two decades to...

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities...

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two...

 By Lynn L. Bergeson and Carla N. Hutton   On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on October 21, 2022, that it recently reviewed a corn plant and a potato plant that were modified using genetic engineering to determine whether they present an increased pest risk as compared to unmodified plants. APHIS has posted its Regulatory Status Review (RSR) responses on its website, as required under 7 C.F.R. Part 340. According to...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Biotechnology Risk Assessment Research Grants (BRAG) program supports the generation of new information that will assist federal regulatory agencies in making science-based decisions about the environmental effects of introducing genetically engineered organisms. In an October 27, 2022, technical assistance webinar, staff will provide an overview of the program, which is jointly administered by...

By Lynn L. Bergeson and Carla N. Hutton   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 December 8, 2022. BRS will offer in-person, at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland 20737, and virtual options for attendance. Attendees will hear updates about BRS’s implementation of the revised biotechnology regulations,...

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact sheet on the summit, federal...

By Lynn L. Bergeson and Carla N. Hutton   On September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On September 14, 2022, the White House will host a Summit on the National Biotechnology and Biomanufacturing Initiative during which cabinet agencies will announce a wide range of new investments and resources...

On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics such as what microorganisms are regulated, permit...

 On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics such as what microorganisms are regulated, permit...

By Lynn L. Bergeson and Carla N. Hutton   On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics...

By Lynn L. Bergeson On May 12, 2021, from 3:30 p.m. to 5:00 p.m. (EDT), the European Commission (EC) Helpdesk will host a webinar on appropriate Intellectual Property (IP) rights for biotechnology inventions.  The 60-minute webinar will provide an overview of: Relevant IP rights; Product development IP context; IP specifics in biotechnology; IP portfolio development; and IP portfolio management. The webinar is free of charge, but registration is required.  Additional information...

By Lynn L. Bergeson On June 26, 2020, the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the winners of its 2020 Start-Up Stadium competition. The competition had 30 finalists that were evaluated during BIO Digital in June, by expert judges with backgrounds in investment, entrepreneurship, start-ups, economic development, capital formation, and academia. Five winners were chosen based on their commercially viable...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. The international standards organization, ASTM International, is seeking additional task group members to further develop the current terminology standard in industrial biotechnology (E3072-19). ASTM International develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Its sub-committee, E62.91 for Terminology in Industrial Biotechnology, is responsible for suggesting new...

By Lynn L. Bergeson Pennsylvania State University’s (Penn State) Huck Institutes of the Life Sciences’ Center of Excellence in Industrial Biotechnology (CoEIB) is now offering a new round of IMPACT Seed Grants to support interdisciplinary research, curricular development, or educational activities in the broad area of industrial biotechnology. These areas include but are not limited to: biopharmaceutical manufacturing, food biotechnology, and production of biobased chemicals....