August 5, 2025

USDA Seeks Public Comment on Reorganization Plan

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...
August 4, 2025

Bipartisan Ag BIO Act Introduced in the Senate

On July 31, 2025, Senators Amy Klobuchar (D-MN) and Jerry Moran (R-KS) introduced bipartisan legislation to enhance the ability of the U.S. Department of Agriculture’s (USDA) Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program to support the development of advanced biofuels, renewable chemicals, and biobased products. According to Klobuchar’s July 31, 2025, press release, the Agricultural Biorefinery Innovation and Opportunity (Ag BIO) Act will update the...
July 18, 2025

APHIS Updates Practices for Reviewing Petitions Seeking a Determination of Nonregulated Status for Organisms Altered or Produced through Genetic Engineering

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...
July 8, 2025

APHIS Seeks Comment on Draft Environmental Documents for Deregulation of American Chestnut Developed Using Genetic Engineering 

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...
July 7, 2025

APHIS Amends Regulations to Conform to Vacatur of SECURE Rule

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...
July 2, 2025

NSCEB Seeks Input to Modernize Biotechnology Product Regulation

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...
June 30, 2025

BIOTech Caucus Will Advance Domestic Bioeconomy and Competitive Posture

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...
June 23, 2025

APHIS Announces Updated Pre-Application Questionnaire in APHIS eFile

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...