B&C Reports on Recent Federal Developments for December 2025
B&C, Acta, And BCCM To Publish Forecast 2026
Start 2026 with the information you need — Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) will publish our Forecast for U.S. Federal and International Chemical Regulatory Policy 2026 the first week of January 2026. In the Forecast, our legal, scientific, and regulatory professionals distill key trends in U.S. and global chemical law and provide their best-informed judgment of key developments likely in the coming year.
Learn More About The 31st Annual Green Chemistry Challenge Awards
The American Chemical Society (ACS) and B&C were pleased to present “31st Annual Green Chemistry Challenge Awards: New Categories and Expanded Opportunities.” This webinar, now available on-demand, features Richard E. Engler, Ph.D., Director of Chemistry at B&C and former leader of EPA’s Green Chemistry Program; Lynn L. Bergeson, Managing Partner of B&C; Adelina Voutchkova, Ph.D., Director of Sustainable Development at ACS and leader of the ACS Green Chemistry Institute®; and Edmond Lam, Ph.D., Assistant Director of the ACS Green Chemistry Institute, discussing the new opportunities available in this year’s awards, sharing guidance and tips on preparing a strong awards entry package, and providing case studies on how past entrants have found investment, forged partnerships, and enhanced their market position as a result of their participation in the Green Chemistry Challenge Awards. Lynn L. Bergeson, Adelina Voutchkova, Ph.D., and Richard E. Engler, Ph.D., build upon this conversation in “Inside ACS’s Green Chemistry Challenge — A Conversation with Adelina Voutchkova, Ph.D. and Richard E. Engler, Ph.D.” on the All Things Chemical® Podcast page.
EPA Posts FAQs Regarding Pesticides Containing A Fluorinated Carbon
The U.S. Environmental Protection Agency (EPA) has posted a web page entitled “Pesticides Containing a Single Fluorinated Carbon.” The web page includes a list of frequently asked questions (FAQ) regarding pesticidal substances containing a single fluorinated carbon and how EPA evaluates them. EPA intends the FAQs to inform the public better about EPA’s gold-standard science pesticide registration process. EPA notes that the web page “does not, and is not intended to, interpret or amend any regulatory or statutory provision, nor does it consider, decide, or prejudge any pending petitions for rulemaking under the pesticide program.” EPA states that it will not use the information on the page for any regulatory purpose. More information is available in our November 14, 2025, blog item.
EPA Preliminarily Determines That 1,2-Dichloroethane Poses Unreasonable Risk To Human Health And The Environment
On November 19, 2025, EPA announced the availability of and requested comment on a draft risk evaluation under the Toxic Substances Control Act (TSCA) for 1,2-dichloroethane (Chemical Abstracts Service Registry Number® (CAS RN®) 107-06-2, also known as ethylene dichloride or EDC). 90 Fed. Reg. 52054. EPA notes that the purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use (COU), including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, and without consideration of costs or non-risk factors. EPA states that it used “the best available science to prepare this draft risk evaluation and to preliminarily determine, based on the weight of scientific evidence, that EDC poses unreasonable risk to human health and the environment driven primarily by certain COUs analyzed in the draft risk evaluation.” Comments on the draft risk evaluation are due January 20, 2026. The draft risk evaluation and supporting documents are available on EPA’s website. For more information, please read our November 20, 2025, memorandum.
EPA Will Reconsider December 2024 Health And Safety Reporting Rule
On November 24, 2025, EPA announced that it intends to reconsider the December 13, 2024, rule issued under Section 8(d) of TSCA that requires manufacturers (including importers) of 16 chemicals to report data from unpublished health and safety studies to EPA. EPA notes that on February 25, 2025, the rule was challenged in the D.C. Circuit Court of Appeals. EPA states that it is asking the court to put the ongoing litigation in abeyance while it reconsiders the rule through notice-and-comment rulemaking. According to the press release, EPA “expects to consider additional exemptions for manufacturers required to report, a regulatory threshold for reporting, and a change to the duration of the lookback period for reporting. EPA is not considering changing the 16 chemicals named in the rule as part of this action.” EPA expects the rulemaking process, including regulatory changes, to take between 12 and 18 months. EPA also anticipates taking appropriate action on the reporting deadline (May 22, 2026) associated with the current rule. More information on the December 2024 rule is available in our December 23, 2024, memorandum.
EPA Publishes Default Values Used In New Chemical Risk Assessments Under TSCA
On November 24, 2025, EPA released the key default values that it uses in its risk assessments of new chemicals under TSCA. EPA is making the assumptions available on its website in the New Chemicals Division Reference Library. EPA states that it expects the publication of the default values “to improve efficiency, reducing the likelihood that submissions need to be reworked or resubmitted.”
According to EPA, providing these established numeric assumptions will help new chemical submitters better understand EPA’s chemical assessment process and develop higher-quality submissions. This is the latest in a series of steps that EPA has taken to improve efficiency, worker protections, and transparency in new chemical reviews. In June 2024, Michal Ilana Freedhoff, Ph.D., then Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), announced four new initiatives in EPA’s review of new chemicals under TSCA: engineering checklist; worker protections; updated statistics for new chemical review timelines; and the New Chemicals Division Reference Library. More recently, in April 2025, EPA announced the availability of new resources intended to help companies with the requirements in EPA’s December 2024 final rule governing the review of new chemicals. According to EPA, the new materials “provide companies with clear instructions on how to include required data elements in the current system used for new chemical submissions while the agency works to update that system.”
EPA notes that under TSCA Section 5, it is required to review new chemicals before they may be manufactured, processed, or used, to determine whether they present an unreasonable risk of injury to human health or the environment. The reviews include an assessment of how much of the chemical may be released into the environment and the potential exposure levels in the workplace. EPA states that “[w]hen chemical-specific information is not available or substantiated — such as the type of containers used to transport the chemical or the quantity of residue that remain in process equipment before they are cleaned out — EPA uses assumptions to assess levels of environmental release and worker exposure during the lifecycle of a new chemical.” More information is available in our November 25, 2025, memorandum.
Senate Confirms Douglas Troutman To Be EPA Assistant Administrator For Toxic Substances
On December 11, 2025, the Senate voted 52-47 to approve several nominations, including Douglas Troutman to be Assistant Administrator of EPA’s OCSPP. During an October 8, 2025, hearing on his nomination, Troutman agreed that the issue with new chemical reviews is both timeliness and outcomes. Troutman noted that “there are new resources coming to the office of chemical safety and pollution prevention, both in new team members, but also in additional resources, such as technological resources, IT resources, which we appreciate from Congress to speed up those reviews and to make sure they are done in a timely manner.” Troutman testified that he would work with Congress on bipartisan legislation to address gaps where the current implementation of TSCA has fallen short.
RCRA/CERCLA/CWA/CAA/PHMSA/SDWA
EPA Proposes Updated Definition Of “Waters Of The United States”
On November 20, 2025, EPA and the U.S. Department of the Army published a proposed rule that would revise the regulations defining the scope of waters covered by the Clean Water Act (CWA), in light of the U.S. Supreme Court’s 2023 decision in Sackett v. EPA. 90 Fed. Reg. 52498. EPA states in its November 17, 2025, press release that the proposed rule would “establish a clear, durable, common-sense definition of ‘waters of the United States’ (WOTUS)” under the CWA. According to EPA’s press release, key proposed revisions include:
- Defining key terms like “relatively permanent,” “continuous surface connection,” and “tributary” to delineate appropriately the scope of WOTUS consistent with the CWA and Supreme Court precedent;
- Establishing that jurisdictional tributaries must connect to traditional navigable waters either directly or through other features that provide predictable and consistent flow;
- Reaffirming that wetlands must be indistinguishable from jurisdictional waters through a continuous surface connection, which means that they must touch a jurisdictional water and hold surface water for a requisite duration year after year;
- Strengthening state and tribal decision-making authority by providing clear regulatory guidelines while recognizing their expertise in local land and water resources;
- Preserving and clarifying exclusions for certain ditches, prior converted cropland, and waste treatment systems;
- Adding a new exclusion for groundwater; and
- Incorporating locally familiar terminology, such as “wet season,” to help determine whether a water body qualifies as WOTUS.
In addition, the limitation to wetlands that have surface water at least during the wet season and abut a jurisdictional water will further limit the scope of permafrost wetlands that are considered to have a continuous surface connection under the proposed rule. EPA states that the proposed changes are intended to provide clarity and consistency to the continuous surface connection definition. Comments are due January 5, 2026.
PHMSA Memorandum Outlines Data-Driven Framework For Hazmat Transportation Inspection And Enforcement Standards
William Quade, Acting Associate Administrator for Hazardous Materials Safety of the Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a November 20, 2025, memorandum establishing the inspection and enforcement priorities of PHMSA’s Office of Hazardous Materials Safety (OHMS). According to the memorandum, OHMS’ outreach priorities “are designed to improve industry engagement, to increase awareness of regulatory requirements, and to build stronger compliance partnerships”:
- Increasing communication and engagement with hazardous materials shippers: Strengthening dialogue with industry stakeholders promotes trust, encourages collaboration, and provides opportunities to address compliance issues before they result in enforcement actions;
- Supporting shipper understanding and compliance with hazardous materials package selection requirements: Clear guidance helps to reduce packaging-related violations, to mitigate the risk of leaks or spills during transportation, and to ensure the safe delivery of hazardous materials; and
- Promoting proper classification of materials prior to shipment: Accurate classification is fundamental to safe transportation. By reinforcing this requirement, we can reduce misclassified shipments, prevent serious safety hazards, and maintain a high level of industry accountability.
The inspection priorities target the highest-risk areas in hazardous materials transportation, more effectively preventing incidents and ensuring compliance:
- General hazardous materials shippers: Routine oversight of shippers helps ensure that the foundational requirements of the hazardous materials regulations (HMR) are consistently met;
- Cylinder requalification facilities: Proper cylinder maintenance and requalification are essential to preventing catastrophic failures during transportation;
- Cylinder manufacturing (both foreign and domestic entities): Ensuring compliance at the point of manufacture supports the safe distribution and use of cylinders throughout the supply chain;
- Drum manufacturing operations: Quality oversight at manufacturing facilities minimizes risks associated with packaging failures;
- Drum recertification entities: Verifying recertification processes protects the integrity of reused packaging and prevents unsafe containers from re-entering commerce;
- Follow-up inspections of companies with previous major safety violations (recidivism focus): Revisiting high-risk companies reinforces compliance expectations and helps deter repeat violations;
- Shippers of lithium batteries: Increased oversight in this rapidly growing sector helps prevent incidents associated with improperly packaged or declared batteries; and
- Undeclared hazardous material shippers operating via e-commerce platforms: Targeting undeclared shipments strengthens our ability to address emerging risks in an evolving marketplace.
The enforcement priorities are intended to maintain adherence to regulatory requirements and internal standards, continuing to advance safety by incorporating ongoing findings from inspection results, monitoring industry and individual practices:
- Ensure Timely and Accurate Case Processing: All enforcement reports must be processed in accordance with the most current OHMS Operations Manual, with common warning letters and tickets closed or referred to collections in the Case Management System (CMS) within 180 days;
- Focus on Risk-Based Enforcement: Prioritize enforcement actions based on violations that present the highest risk to public safety, the environment, and national security;
- Promote National Consistency and Accountability: Regional leadership must apply penalty guidelines uniformly and monitor performance metrics to ensure consistent and transparent enforcement outcomes across all regions; and
- Leverage Data to Drive Strategic Improvements: Use enforcement trends and CMS analytics to inform policy decisions, enhance compliance strategies, and proactively address recurring or emerging violations.
EPA Begins Public Comment Period On Updated Draft Risk Calculation Memorandum For Formaldehyde
On December 3, 2025, EPA announced the availability of and solicited public comment on an Updated Draft Risk Calculation Memorandum (Draft Memorandum) to inform a revised draft risk evaluation for formaldehyde under TSCA. 90 Fed. Reg. 55726. EPA states that after further consideration of comments raised during the scientific peer review process, it is reconsidering the use of certain hazard values in the formaldehyde risk evaluation. The Federal Register notice, Draft Memorandum, and materials included in the docket provide the science and science policy basis for determining how the revised draft inhalation point of departure (POD) impacts the corresponding draft margin of exposure (MOE) estimates and the risk determination. EPA notes that although it is also providing a revised draft occupational exposure value, it “is not changing its position that formaldehyde poses unreasonable risk of injury to human health.” As such, EPA continues work on a proposed risk management rule for formaldehyde as required by TSCA to ensure statutory deadlines are met and necessary protections are not delayed. According to the notice, EPA is also seeking additional information specific to how formaldehyde is manufactured and used that may inform the risk management of formaldehyde. After public comment, EPA will determine if the proposed revisions discussed in the notice warrant updating the formaldehyde risk evaluation. Comments are due February 2, 2026. More information is available in our December 8, 2025, memorandum.
PHMSA Publishes ANPRM Regarding Modernizing Regulations To Facilitate Transportation Of Hazardous Materials Using Highly Automated Transportation Systems
PHMSA published an advance notice of proposed rulemaking (ANPRM) on December 4, 2025, to obtain stakeholder input on potential revisions to the HMR “to facilitate the safe transportation of hazardous materials using highly automated transportation systems.” 90 Fed. Reg. 55836. PHMSA states that for the purposes of the ANPRM, it “considers highly automated transportation systems as advanced transportation systems that leverage varying degrees of automation, tailored to the system’s complexity.” According to PHMSA, the emergence of highly automated technology has the potential to transform how hazardous materials are transported while potentially enhancing safety, efficiency, and reliability. This shift warrants a comprehensive review of the requirements in the HMR. PHMSA intends the ANPRM to solicit feedback that it can use in performing that review. Comments are due March 4, 2026. PHMSA states that it “will consider late-filed comments to the extent possible,” however.
House Subcommittee Will Hold Hearing To Examine The Impact Of The CERCLA Designations For PFOA And PFOS And Potential Policy Responses To Superfund Liability Concerns
On December 18, 2025, the House Energy and Commerce Subcommittee on Environment will hold a hearing on “Examining the Impact of EPA’s CERCLA Designation for Two PFAS Chemistries and Potential Policy Responses to Superfund Liability Concerns.” In May 2024, EPA issued a final rule designating perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), and their salts and structural isomers as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 89 Fed. Reg. 39124. Despite EPA stating that it would use its discretion to target active contributors, the final rule was promptly criticized for not excluding passive receivers. More information is available in our December 12, 2025, blog item.
FDA Issues Warning About Imported Cookware
On December 3, 2025,the U.S. Food and Drug Administration (FDA) issued a warning that certain imported cookware products have the potential to leach lead into food when used for cooking or food storage. FDA reportedly has tested various cookware, specifically aluminum alloys known as Hindalium/Hindolium or Indalium/Indolium, and maintains a list of products that may leach lead into food. FDA has stated that it is actively working to remove cookware from the market that may leach lead into food when used for cooking and that FDA’s surveillance is ongoing.
FDA Reschedules Food Allergen Meeting
On December 10, 2025, FDA announced that the Virtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications meeting has been rescheduled to February 18, 2026, and the listening sessions to February 19-20, 2026. During the events, FDA will provide background on major food allergen requirements, current regulatory frameworks, risk assessment methodologies for establishing food allergen thresholds, potential applications of risk-based food allergen thresholds and communication, and global approaches to food allergen management. FDA is accepting questions until February 3, 2026,and registration is open until February 18, 2026.
FDA Publishes Food Code Adoption Report
On December 9, 2025, FDA announced the publication of the Adoption of the FDA Food Code by State and Territorial Agencies Responsible for the Oversight of Restaurants and/or Retail Food Stores—2024 Annual Report. The report provides information on state agencies and jurisdictions that, as of 2024, have adopted a version of the FDA Food Code. Key metrics are listed below:
• 11 state agencies in 7 states have adopted the most recent version (2022 version), representing 16.06% of the U.S. population . . ..
• 30 state agencies in 24 states have adopted one of the two most recent versions (2022 and 2017 version), representing 51.92% of the U.S. population.
• 46 state agencies in 36 states have adopted one of the three most recent versions (2022, 2017, and 2013 version), representing 64.64% of the U.S. population.
UK NanoSafety Group Publishes Updated Guidance On Working Safely With Nanomaterials
The United Kingdom (UK) NanoSafety Group (UKNSG) has published the third edition of its guidance entitled “Working Safely with Nanomaterials in Research & Development.” The guidance is intended to provide help and support to research laboratories in industry, research, and training organizations and academia on how to comply with their occupational health and safety legal obligations. The guidance also includes additional information to help improve health and safety systems when working with nanomaterials.