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...
Regulatory, legal, policy, and business developments in renewable chemicals, biofuels, and other biobased products
The Clean Air Act (CAA) requires the U.S. Environmental Protection Agency (EPA) to determine the applicable volume requirements for the Renewable Fuel Standard (RFS) for years after those specified in the statute. On June 17, 2025, EPA proposed the applicable volumes and percentage standards for 2026 and 2027 for cellulosic biofuel, biomass-based diesel (BBD), advanced biofuel, and total renewable fuel. 90 Fed. Reg. 25784. EPA notes that the proposed rule also includes a number of regulatory...
June 6, 2025
Call for Evidence for Impact Assessment of the European Biotech Act Will Close June 11, 2025
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,...
May 30, 2025
BETO Updates 45ZCF-GREET Model to Incorporate New Methods of Alternative Fuel Production
On May 30, 2025, the U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced that it “removed barriers to domestic bioenergy production by updating its 45ZCF-GREET modeling tool to account for new feedstocks and methods of production, including ethanol from corn wet-milling and natural gas from coal-mine methane.” According to BETO, these measures will allow a wider range of farmers and companies to do business in the alternative fuels market. BETO notes that the U.S....
On May 7, 2025, Representatives Nikki Budzinski (D-IL) and Zach Nunn (R-IA) introduced the Agricultural Biorefinery Innovation and Opportunity Act (Ag BIO Act) (H.R. 3253), a bipartisan bill that would support the biofuel economy. According to Budzinski’s May 8, 2025, press release, the bill would update the U.S. Department of Agriculture’s (USDA) Section 9003 program to expand access to grants, streamline loan guarantees, and provide $100 million in mandatory funding over five years. The...
April 30, 2025
National Biotechnology Initiative Act Would Implement Recommendations from NSCEB’s Final Report
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 U.S. Environmental Protection Agency (EPA) announced on April 28, 2025, that it has issued an emergency fuel waiver allowing the sale of gasoline blended with 15 percent ethanol (E15) nationwide in summer 2025. EPA notes that this is consistent with President Trump’s Executive Order (EO) Declaring a National Energy Emergency, directing EPA to consider issuing emergency waivers to allow for year-round E15 sales. According to EPA, currently, in about half of the country, E15 cannot be sold...
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...