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...
Regulatory, legal, policy, and business developments in renewable chemicals, biofuels, and other biobased products
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,...
July 1, 2025
APHIS Seeks Comment on Petition to Deregulate Orchid Developed Using Genetic Engineering
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...
June 26, 2025
NASEM Will Hold Workshop on Synthetic Biology for Biomanufacturing and Predictable Engineering on July 1, 2025
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 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...