Blogs

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,...

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 20, 2025, the Organisation for Economic Co-operation and Development (OECD) published a report entitled Per- and Polyfluoroalkyl Substances (PFAS) and Alternatives in Hydraulic Oils and Lubricants: Report on Commercial Availability and Current Uses. The report examines the commercial availability and current uses of PFAS and non-PFAS alternatives in lubricants and hydraulic oils within the framework of the Global PFAS Group. OECD notes that it considered publicly available information...

On June 11, 2025, the Nanotechnology Industries Association (NIA) published a position paper entitled Bridging the Governance Gap: Divergent EU Approaches to Nano and Advanced Materials that highlights industry challenges with divergent approaches to nano and advanced materials in the European Union (EU). NIA notes that the EU “is at a critical juncture in the approach that it takes towards nano and other advanced materials.” According to NIA, with the European Commission’s (EC)...

On June 26, 2025, the California Department of Pesticide Regulation (DPR) issued California Notice 2025-08 announcing that pesticide registrants may add or revise multilingual translation of its labels by non-notification. With this change, DPR now is consistent with the U.S. Environmental Protection Agency’s (EPA) decision to allow pesticide registrants to add the required Spanish-translated sections on its labels by non-notification as part of the Spanish translation requirements under the...

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...

On June 16, 2025, the U.S. Environmental Protection Agency (EPA) filed a motion with the U.S. Court of Appeals for the Fifth Circuit requesting that litigation over its 2024 final rule regulating chrysotile asbestos under the Toxic Substances Control Act (TSCA) be held in abeyance for an additional six months. According to the filing, EPA intends to initiate a new notice-and-comment rulemaking to reconsider certain provisions of the rule. The litigation, Texas Chemistry Council, et al. v. EPA,...

This week the Minnesota Pollution Control Agency (MPCA) posted Parts One and Two of its response to pre-hearing and hearing comments. Part One states that 67 commenters submitted written comments on the April 2025 proposed rule. During the May 22, 2025, hearing on the proposed rule, 11 stakeholders presented verbal testimony. According to the document, MPCA has reviewed the comments and “has identified some parts of the proposed rule that require clarification, or that the agency would...

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 12, 2025, the U.S. Environmental Protection Agency (EPA) announced the availability of updated refined interim core maps that identify areas that EPA states are important to 12 threatened or endangered (listed) species and their critical habitats as designated by the U.S. Fish and Wildlife Service (FWS). These refined interim maps are based on information developed by FWS and were developed by EPA’s Office of Pesticide Programs (OPP), the Center for Biological Diversity (CBD), and...

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 U.S. Department of Agriculture (USDA) has been around for more than 150 years, stressing the importance of American agriculture to a bountiful food production system since Abraham Lincoln first signed it into being in 1862. Lincoln himself, in fact, in his 1864 final annual message to Congress, christened USDA “the people’s Department,” just before commending it “to the continued attention and fostering care of Congress.” From industrialization to the mechanization of farming,...

The U.S. Environmental Protection Agency (EPA) provided on update on June 18, 2025, on the status of the December 2024 Toxic Substances Control Act (TSCA) risk management rule for trichloroethylene (TCE). According to EPA, it is postponing until August 19, 2025, certain requirements already postponed in March 2025. EPA notes that these requirements relate only to the TSCA Section 6(g) exemptions in the final TCE rule. According to EPA, “[t]his will ensure that the timing of EPA’s...

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...

On June 16, 2025, the U.S. Environmental Protection Agency (EPA) announced the release of the draft charge questions for discussion at the upcoming Science Advisory Committee on Chemicals (SACC) meeting to review all documents released thus far on the risk evaluations of five phthalates. SACC will review the draft risk evaluations for dibutyl phthalate (DBP), di(2-ethylhexyl) phthalate (DEHP), and dicyclohexyl phthalate (DCHP), as well as cross-cutting documents related to DBP, DEHP, DCHP, butyl...

As reported in our May 13, 2025, blog item, on March 24, 2025, PPG Industries, Inc. (PPG) submitted a petition seeking an amendment to the U.S. Environmental Protection Agency’s (EPA) December 2024 final risk management rule for trichloroethylene (TCE). PPG requested an amendment to the exemption for the industrial and commercial use of TCE as a processing aid for specialty polymeric microporous sheet materials manufacturing that would allow PPG to meet an interim existing chemical exposure...

The Washington Department of Ecology (WDOE) issued a proposed rule on June 4, 2025, that would regulate per- and polyfluoroalkyl substances (PFAS) in certain consumer products. Beginning January 1, 2027, the proposed rule would prohibit the intentional use of PFAS in: Apparel and accessories; Automotive washes; and Cleaning products. The proposed rule states that WDOE would presume the detection of total fluorine indicates the intentional addition of PFAS. Manufacturers would be able to rebut...

Bergeson & Campbell, P.C. (B&C®) is pleased to present “Loper Bright: Has the Demise of Chevron Deference Mattered?,” a complimentary webinar reviewing changes to Toxic Substances Control Act (TSCA) determinations in light of Loper Bright. The U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo offered a new response to a long-standing question under administrative law: if an agency and a reviewing court’s interpretations of a federal statute...

On June 5, 2025, the Joint Economic Committee (JEC) of the U.S. Congress convened a hearing titled “Barriers to Supply Chain Modernization and Factor Productivity Enhancements.” Throughout the hearing, members and witnesses alike underscored the role of “regulatory friction” -- especially in the form of fragmented and unpredictable requirements -- as a key factor slowing investment in domestic manufacturing and threatening supply chain resilience. While the U.S. Environmental Protection...