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...