Recent Federal Developments for September 2025 – Update from Bergeson & Campbell, P.C.
Recent Federal Developments – September 2025
FIFRA Fundamentals, September 24-25, 2025, via webinar: Bergeson & Campbell, P.C. (B&C®) and Chemical Watch are pleased to presentFIFRA Fundamentals, a two-day course taught by professionals from B&C’s renowned Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) team. Lisa R. Burchi, Of Counsel; Heather F. Collins, M.S., Regulatory Consultant; Dana S. Lateulere, Regulatory Consultant; and Meibao Zhuang, Ph.D., Senior Scientist/Regulatory Consultant, will share legal, scientific, and policy knowledge needed to support strategic planning of pesticide-related compliance requirements. Firm clients and friends may contact events@chemicalwatch.com and share code BC-FIFRA15 to receive 15% off the cost of registration.
Bergeson & Campbell, P.C. And LexisNexis Publish 2025 Edition Of Guide to the Toxic Substances Control Act (TSCA): B&C is pleased to announce publication of the 2025 edition of Guide to the Toxic Substances Control Act (TSCA), LexisNexis (Guide to TSCA). Authored by members of B&C’s renowned TSCA practice group, including Lynn L. Bergeson, Heather J. Blankinship, Lisa R. Burchi, Richard E. Engler, Ph.D., Kelly N. Garson, Lara A. Hall, RQAP-GLP, and Carla N. Hutton, the Guide to TSCA is the definitive comprehensive treatise on TSCA, written for lawyers, regulatory affairs specialists, and commercial and business people who need to understand the details of this law. Firm clients and friends may use the code TSCASAVE20 through December 31, 2025, for 20% off the cost of the book when purchasing via the LexisNexis online store.
CEA Withdraws Section 21 Petition Seeking Reconsideration Of 2024 Rule Regarding Procedures For Chemical Risk Evaluation; EPA Intended To Issue NPRM In July 2025: As reported in our May 30, 2025, blog item, on May 15, 2025, the Center for Environmental Accountability (CEA) filed a petition under Section 21 of TSCA requesting that the U.S. Environmental Protection Agency (EPA) reconsider the 2024 final rule regarding procedures for chemical risk evaluation under TSCA and initiate a rulemaking to amend certain provisions in 40 C.F.R. Part 702, subpart B. According to CEA, the current process “has led to overly conservative risk conclusions and, in turn, unnecessary risk management rules that force industry to abandon well-studied chemistries that provide beneficial uses in our daily lives.” According to an August 13, 2025, letter from EPA, on August 12, 2025, CEA withdrew its petition and EPA now considers the petition closed. More information is available in our September 5, 2025, blog item.
EPA Releases New Mobile Tool To Help Farmers Implement Recommended Ecological Pesticide Mitigation Measures And Announces Webinar On Mitigation Measures: On August 14, 2025, EPA announced the availability of its Pesticide App for Label Mitigations (PALM), which is described as an “easy-to-use, mobile-friendly tool to serve as a one-stop shop that helps farmers and applicators use EPA’s mitigation menu to reduce pesticide exposure to nontarget species from agricultural crop uses.” According to EPA, this new tool will allow farmers to access quickly mitigation information from the final Insecticide Strategy, Herbicide Strategy, and other strategies while in the field. To assist the public on how to use the new mobile tool PALM and provide information on mitigation measures for pesticide users, EPA will be holding a public webinar on September 16, 2025. Information on how to register for the webinar is available here. EPA states it encourages users to submit feedback on and suggest future enhancements to PALM. To submit feedback on PALM, please e-mail PALM@epa.gov. For more information on the new mobile tool, please read our August 22, 2025, blog item.
GAO WatchBlog Item Looks At Earlier Report On EPA’s New Chemicals Program: The U.S. Government Accountability Office (GAO) announced on August 14, 2025, a WatchBlog item entitled “EPA’s New Chemicals Program Could Improve Safety If Better Managed” that examines GAO’s January 2025 report on EPA’s New Chemicals Program (NCP). In its January 2025 report, GAO reviewed EPA’s efforts and interviewed some chemical manufacturers that had submitted notices for new chemicals. While many manufacturers cited strengths in the NCP, GAO states that some manufacturers reported experiencing delays that have impacted their businesses, “including by harming customer relations and hindering their ability to enter the market.” GAO notes that a delay “could create a competitive advantage for existing chemicals at the expense of potentially safer new chemicals.” GAO’s January 2025 report included recommendations for how EPA could address shortcomings in its plan to improve the performance of the NCP. More information on GAO’s report is available in our January 23, 2025, blog item.
EPA Extends Postponement Of Effective Date Of Certain Provisions Of Final TCE Risk Management Rule; Will Issue Interim Final Rule On Compliance Date Extensions: On August 20, 2025, EPA extended the postponement of the effectiveness of certain regulatory provisions of the final TSCA risk management rule for trichloroethylene (TCE) to November 17, 2025. 90 Fed. Reg. 40534. EPA is postponing certain requirements most recently postponed in June 2025. EPA notes that these requirements relate only to the TSCA Section 6(g) exemptions in the final TCE rule. EPA states that “[i]n light of the fact that the pending litigation is still ongoing and for the same reasons as set forth in the Initial Notice, EPA has determined that justice requires a 90-day extension of the postponement of the effective date (i.e., until November 17, 2025) of the conditions for each of the TSCA section 6(g) exemptions.” More information is available in our August 22, 2025, blog item.
EPA announced on September 12, 2025, that it is issuing an interim final rule for risk management for TCE. The interim final rule keeps the ban in place while extending compliance dates for critical infrastructure and national security applications resulting from the use of TCE as a processing aid in the manufacture of nuclear fuel and for certain processors of industrial chemicals who dispose of TCE to wastewater. According to EPA, these changes are intended to provide impacted businesses with a reasonable transition time timeline to comply with the provisions of the risk management rule. Publication of the interim final rule in the Federal Register will begin a 30-day comment period. EPA notes that the current deadlines remain effective until modified through the rulemaking, but “[e]nforcement of the current deadlines is a low enforcement priority for the agency, and EPA intends to focus its resources on compliance with the new compliance dates that will be established by this rulemaking.”
EPA Releases White Paper On Determining The Absence Of Novel Proteins In The Saliva Of Genetically Engineered Mosquitoes For Mosquito Control:EPA announced on August 21, 2025, the availability of and solicited public comment on materials that are being submitted to the FIFRA Scientific Advisory Panel (SAP) for peer review on “Determining the Absence of Novel Proteins in the Saliva of Genetically Engineered Mosquitoes for Mosquito Control.” 90 Fed. Reg. 40829. The white paper, charge questions, background documents, and related supporting materials are available for public review and comment. Written comments on the peer review documents (white paper, charge questions, background documents, and related supported materials) are due September 22, 2025. The FIFRA SAP will consider and review the documents at a three-day virtual public meeting November 3-5, 2025. EPA called for public comment on the candidates being considered as ad hoc peer reviewers on August 20, 2025. EPA will post information on its website on how to register for the meeting and provide comments in October 2025. More information is available in our August 25, 2025, blog.
TRI National Analysis For RY 2023 Shows Decrease In Releases: EPA released on August 21, 2025, its Toxics Release Inventory (TRI) National Analysis for reporting year (RY) 2023, which “shows that toxic chemical releases have decreased as the chemical industry’s contribution to the national Gross Domestic Product (GDP) has increased.” According to EPA, highlights from the analysis include:
- Between 2014 and 2023, environmental releases of TRI-listed chemicals fell 21 percent, including a 32 percent decrease in air releases. During this ten-year period, releases from manufacturing facilities decreased by 15 percent while the manufacturing sector’s contribution to the U.S. GDP increased by 13 percent;
- A feature profile on automotive manufacturing shows that, from 2014 to 2023, this sector’s value to the economy increased by 34 percent while chemical releases decreased by 14 percent;
- In 2023, facilities managed 90 percent of their TRI chemical waste through preferred practices such as recycling, energy recovery, and treatment;
- From 1998 to 2023, companies managing TRI chemicals, which include lead, mercury, dioxins, and per- and polyfluoroalkyl substances (PFAS) chemicals, have decreased releases by 54 percent while the national GPD has increased by 74 percent; and
- For RY 2023, nine PFAS were added to the reporting requirements for a total of 189 PFAS tracked by the TRI program. During 2023, 61 facilities managed 1.6 million pounds of PFAS as waste and decreased chemical releases by 16 percent.
EPA will hold a public webinar on September 30, 2025, at 3:00 p.m. (EDT) to provide an overview of the 2023 TRI National Analysis.
EPA Submits Proposed Rule Revising TSCA Section 8(a)(7) PFAS Rule To OMB For Review: According to the Office of Management and Budget (OMB) website, on August 29, 2025, EPA submitted a proposed rule entitled “Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping under the Toxic Substances Control Act (TSCA); Revision to Regulation” to OMB for review. When EPA postponed the reporting period from July 11, 2025, to April 13, 2026, EPA indicated that it was separately considering reopening certain aspects of the October 2023 rule to public comment. The proposed rule submitted to OMB is not publicly available.
Nominations Of Peer Reviewers For EPA’s Risk Evaluation Of D4 Are Due September 25, 2025: EPA announced on September 10, 2025, that it is seeking nominations of scientific and technical experts to be considered as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the draft risk evaluation of octamethylcyclotetrasiloxane (D4) under TSCA. EPA states that these nominations will help it select approximately seven to eight ad hoc reviewers to assist SACC with its review. Nominations for ad hoc reviewers should include the candidate’s name, affiliation, contact information, and must be submitted by September 25, 2025, to the Office of Chemical Safety and Pollution Prevention (OCSPP) Peer Review mailbox at ocspp-peerreview@epa.gov.
EPA Will Reconsider Final Risk Management Rule For Carbon Tetrachloride: EPA announced on September 12, 2025, its decision to reconsider the 2024 final risk management rule for carbon tetrachloride. According to EPA, after it published the final rule, several legal challenges were filed. These petitions for review were consolidated in the U.S. Court of Appeals for the Eighth Circuit. EPA has requested that the court hold these cases in abeyance while the Agency reconsiders the final rule. EPA sates that during abeyance, it intends to reconsider the final rule through notice-and-comment rulemaking, including but not limited to the use of the Existing Chemical Exposure Limit (ECEL) of 0.03 parts per million (ppm) promulgated as part of the Workplace Chemical Protection Program for carbon tetrachloride, to ensure that the rule is implementable to protect workers consistent with statutory requirements. EPA plans to open a comment period on the final rule as a first step in its efforts to reconsider and, if appropriate, revise the final risk management rule.
TSCA CBI Substantiations Will Begin To Expire In 2026: Under the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA, most confidential business information (CBI) claims will expire after ten years unless reasserted and substantiated. This means that a CBI claim made in 2016 will expire in 2026 unless the claim is reasserted and resubstantiated before the end of the ten-year period. The beginning of the sunset process will be a challenge and learning experience for submitters and EPA. Submitters should begin now to ensure that their older submissions have up-to-date technical contact(s) and consider adding one or more agents to ensure that EPA will be able to communicate confidently with the contact. Submitters should also monitor the list that EPA posts and watch for updates. More information is available in our September 12, 2025, blog item.
RCRA/CERCLA/CWA/CAA/PHMSA/SDWA
EPA Reviews And Renews Eligibility For Application-Specific HFC Allowances: On August 26, 2025, EPA published a final rule establishing, pursuant to the statutory framework established in the American Innovation and Manufacturing Act of 2020 (AIM Act), the eligibility of six applications to continue to receive priority access to allowances to produce or import hydrofluorocarbons (HFC). 90 Fed. Reg. 41676. The rule establishes the framework for how EPA interprets the statutory criteria for assessing whether to renew the eligibility of applications to receive application-specific allowances and sets out determinations to renew or not renew each of the six applications that currently receive application-specific allowances. EPA is also revising the Technology Transitions regulations relevant to the specific applications under review, a procedural process for submitting a petition to designate a new application as eligible for priority access to allowances, the methodology used to allocate allowances to application-specific allowance holders for calendar years 2026 and beyond, and limited revisions to existing regulations. In addition, EPA is authorizing an entity to produce regulated substances for export. Lastly, EPA is making final certain regulatory confidentiality determinations for newly reported information. The rule will be effective September 25, 2025.
EPA Amends NESHAP For Polyether Polyols Production Industry: On September 2, 2025, EPA amended the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Polyether Polyols Production under the Clean Air Act (CAA). 90 Fed. Reg. 42323. EPA states that “[s]pecifically, for this NESHAP, the EPA is finalizing the removal of affirmative defense provisions associated with the violation of air emission standards due to malfunctions.” The final rule was effective September 2, 2025.
EPA Proposes To End GHG Reporting Program: EPA announced on September 12, 2025, a proposed rule to end the Greenhouse Gas (GHG) Reporting Program. EPA states that “[u]nlike other mandatory information collections under the CAA, the [GHG Reporting Program] is not directly related to a potential regulation and has no material impact on improving human health and the environment.” If issued in final, the proposed rule would remove reporting obligations for most large facilities, all fuel and industrial gas suppliers, and carbon dioxide injection sites. Publication of the proposed rule in the Federal Register will begin a public comment period.
FDA Announces Food Allergen Virtual Meeting: On August 18, 2025, the U.S. Food and Drug Administration (FDA) announced a meeting, “FDA Virtual Public Meeting on Food Allergen Thresholds and Their Potential Applications,” scheduled for November 18-20, 2025. The three-day public meeting will feature presentations and panel discussions by invited speakers on November 18 followed by listening sessions on November 19-20. FDA will open a docket on November 18 for participants to submit comments. Additional meeting details and registration information will be provided in September 2025.
FDA Updates Substances Under Review: On August 19, 2025, FDA announced an update to the “List of Select Chemicals in the Food Supply Under FDA Review” to provide more insight on the status of its post-market assessment of chemicals in the food supply. This updated list includes select food ingredients (including food additives and color additives), food contact substances, and contaminants under FDA review. The chemicals new to the list are:
- Butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT);
- Azodicarbonamide (ADA); and
- FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6.
This post-market review effort is part of a larger initiative to improve food chemical oversight.
FDA Adds Authorized Uses For Hydrogen Peroxide: On September 3, 2025, FDA issued a final amendment order that provides for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. 90 Fed. Reg. 42535. The amendment was in response to a Food Additive Petition (FAP) filed by Cargill, Inc. The secondary direct food additive regulation for hydrogen peroxide at 21 C.F.R Section 173.356 was updated on September 3, 2025, to include the additional uses. Either electronic or written objections and requests for a hearing on the order must be submitted by 11:59 p.m. Eastern Time on October 3, 2025.
FDA Launches Real-Time Adverse Event Reporting Dashboard For Cosmetic Products: FDA announced on September 12, 2025, the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products. According to FDA, “[t]he user-friendly platform allows users to download report listings or data sets, with reports being updated daily to include the most recent submissions.” The dashboard is dedicated exclusively to reports of cosmetic product adverse events, including serious adverse event reports submitted by responsible persons for cosmetic products under requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as well as voluntary adverse event reports submitted to FDA by healthcare professionals, consumers, salon professionals, cosmetologists, and others. The FAERS dashboard contains adverse event reports for cosmetic products, such as moisturizers, shampoos, conditioners, hair dyes and tattoos. FDA notes that it has not verified reports in the dashboard and that their publication does not indicate that FDA has concluded the product caused the adverse event. Additionally, the FAERS data are not an indicator of the safety profile of the cosmetic product. Frequently asked questions (FAQ) are available.
Canada’s Plan Of Priorities Includes Several Nanoscale Materials: On July 23, 2025, Environment and Climate Change Canada (ECCC) announced the release of the Plan of Priorities, a multi-year plan that outlines upcoming priorities for the assessment of chemical substances. The Plan includes a list of more than 30 substances and substance groups prioritized for assessment, including nanoscale silver, nanoscale zinc oxide, and nanoscale forms of titanium dioxide (nano-TiO2). More information is available in our August 29, 2025, blog item.
ISO Publishes Standards For Graphene-Related 2D Materials: The International Organization for Standardization (ISO) recently published two standards for graphene-related two-dimensional (2D) materials:
- ISO/TS 9651:2025, Nanotechnologies — Classification framework for graphene‐related 2D materials; and
- ISO/TS 23359:2025,