EPA Eliminates Backlog of TSCA Substantial Risk Notifications

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EPA has cleared the backlog of section 8(e) submissions under the Toxic Substances Control Act (TSCA) thanks to process improvements, the agency announced on October 10, 2025.

TSCA section 8(e) requires that persons notify EPA when they obtain information that “reasonably supports the conclusion” that a chemical they manufacture, process, or distribute “presents a substantial risk of injury to health or the environment.”

According to the announcement, EPA assembled a team to address the backlog, which reviewed more than 3,000 submissions.  Approximately 920 of those submissions were flagged as “high interest and distributed across the agency.”

To prevent future backlogs, the announcement notes that EPA has established a workgroup to develop process improvements, enhanced its categorization system for incoming submissions, and implemented an automated notification system that alerts staff to relevant submissions.

More on TSCA section 8(e) submissions can be found on EPA’s website.

EPA Adds PFAS to TRI List for 2026 Reporting

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On October 7, 2025, EPA announced the addition of a new PFAS to the Toxics Release Inventory (TRI): PFHxS-Na (CASRN 82382-12-5).  PFHxS-Na is a salt associated with the PFAS PFHxS (CASRN 335-46-4).

The addition takes effect January 1, 2026.  EPA will likely publish the formal amendment to the list of TRI-reportable chemicals in the Federal Register shortly.

Why Was This PFAS Added?

PFHxS-Na was automatically added to the TRI list after EPA finalized a toxicity value for PFHxS and its salts in a 2025 Integrated Risk Information System (IRIS) report.  Under the FY 2020 National Defense Authorization Act (NDAA), PFAS must be added to the TRI list when certain criteria—such as a finalized toxicity value—are met.

According to the announcement, the other PFAS identified in that IRIS assessment are already on the TRI list.

Implications for Reporting Entities

Supplier notifications for PFHxS-Na will be first required as of January 1, 2026, and reporting companies will be required to include PFHxS-Na in their Reporting Year 2026 reports, according to an EPA webpage.

With this update, EPA says that a total of 206 PFAS are now subject to TRI reporting.  The agency previously added nine PFAS to the TRI list in January 2025 for Reporting Year 2025 reports, which are due July 1, 2026.

In addition, EPA has proposed a rule to add 16 individual PFAS and 15 PFAS categories to the TRI list, while also formalizing the criteria for automatic PFAS additions.  The Trump administration’s Spring 2025 Unified Agenda indicates that EPA will finalize the rule in February 2026.

More on that rulemaking and EPA’s other TRI PFAS actions can be found in our TRI archive.

EPA Not Required to Regulate PFAS in Sewage Sludge, Court Rules

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EPA is not required to identify and regulate PFAS in sewage sludge under the Clean Water Act (CWA), a federal judge ruled on September 29, 2025, in Farmer v. EPA, No. 24-cv-1654.

The CWA defines sewage sludge as “solid, semi-solid, or liquid residue generated during the treatment of domestic sewage in a treatment works.”  Every two years, the law mandates that EPA review its sewage sludge regulations and release a report “for the purpose of identifying additional toxic pollutants [in sewage sludge] and promulgating regulations for such pollutants.”

The case was brought by a group of farmers, a nonprofit that promotes organic agriculture, and an organization representing Potomac River watershed residents.  The plaintiffs argued that the widespread use of sewage sludge as fertilizer introduces PFAS into the food chain and contaminates water and property.  “EPA’s failure to identify and regulate PFAS in sewage sludge exposes Plaintiffs to continuing harm from future applications of sewage sludge on nearby properties,” their June 2024 complaint states.

They sought a court order requiring EPA to identify 18 specific PFAS in its next biennial report and to regulate 11 PFAS that the agency had already identified in previous reports—including PFOA and PFOS.

In its opinion, the D.C. District court concluded that the plaintiffs’ request exceeds the CWA’s requirements because the statute does not impose date-certain deadlines on the agency.  “Although the plain language of the CWA imposes a non-discretionary duty on EPA to review its regulations on a biennial basis, it does not mandate that EPA also identify and regulate sewage-sludge pollutants within the same time frame,” the opinion states.

The court further held that neither the biennial report nor EPA’s failure to list pollutants in that report constitutes a final agency action subject to Administrative Procedure Act (APA) review.  However, the court noted that the plaintiffs could challenge EPA’s inaction through a CWA petition, the denial of which “could constitute a final agency action” under the APA.

Company Sues EPA to Block Disclosure of Chemical Identities Under TSCA

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A silicates manufacturer is suing EPA to prevent the disclosure of its confidential business information (CBI) under the Toxic Substances Control Act (TSCA), in what at least one source claims may be a case of first impression under the law.

At issue are the chemical identities of two substances that Burgess Pigment Co. initially failed to substantiate as CBI following the 2016 Lautenberg Amendments to TSCA, which introduced new requirements for companies that seek trade secret protection in their submissions to EPA.

Burgess claims it submitted adequate substantiation once it discovered its oversight, maintained its CBI claim in subsequent filings, and has stayed in “constant contact” with EPA.  According to the complaint, if EPA discloses the chemical identities anyway, it would violate the Administrative Procedure Act (APA).

“EPA’s unreasonable adherence to form over function caused it to fail to adhere to its regulations requiring nondisclosure of properly substantiated CBI and is otherwise arbitrary, capricious, and contrary to law,” the complaint states.

According to the complaint, Burgess was one of many companies that failed to respond to the 2017 rule implementing the new CBI requirements.  In 2021, EPA released a rule to reopen the reporting period, but it was never published in the Federal Register.

The case is Burgess Pigment Co. v. U.S. Environmental Protection Agency, No. 5:25-cv-00309 (M.D. Ga.), filed 7/18/25.

Trump Administration Proposes Overhaul of Biden-Era TSCA Risk Evaluation Framework

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On September 23, 2025, EPA published a proposed rule that would roll back key provisions of the agency’s May 2024 risk evaluation framework rule, which sets out the procedures EPA uses to assess the risks of existing chemicals under the Toxic Substances Control Act (TSCA).

According to EPA, the proposal is intended to “effectuate the best reading of the statute and ensure that the procedural framework rule does not impede the timely completion of risk evaluations or impair the effective and efficient protection of health and the environment.”

The rollback is a priority for the Trump administration, which first announced its intent to reconsider the rulemaking in March.  The 2024 rule—itself a revision of a rule issued during the first Trump administration—has been criticized by industry groups such as the American Chemistry Council and targeted for revision by the Heritage Foundation’s “Project 2025” initiative.

What Changes is EPA Proposing?

If finalized, the rule would:

  • Grant EPA discretion to narrow the scope of risk evaluations by excluding conditions of use and exposure pathways from its assessments.
  • Require that separate risk determinations be made for each of a chemical’s conditions of use, instead of a single risk determination for the chemical as a whole.
  • Remove language prohibiting EPA from assuming worker protections through PPE usage.
  • Eliminate “overburdened communities” from the list of “potentially exposed or susceptible subpopulations” that must be considered in evaluations.
  • Provide EPA with greater flexibility to revise or supplement scope or risk evaluation documents without restarting the prioritization process.
  • Scale back information collection requirements for manufacturers requesting a risk evaluation.
Stakeholder Responses

The proposal has drawn criticism from environmental groups, who warn that the changes—particularly EPA’s ability to exclude conditions of use and exposure pathways—will jeopardize public health.

“Rather than looking at the full picture of a chemical’s toxic risk, EPA wants to downplay the links these chemicals have to cancer and chronic disease and give the chemical industry a handout at the expense of our health and safety,” an Environmental Defense Fund official said in a statement.

“The chemicals in the pipeline for review under TSCA have been prioritized specifically because of the risks they pose to our health, and rewriting this process to lowball risks will only rig the rules to benefit the chemical industry,” she continued.

The American Chemistry Council, on the other hand, applauded the move.  “This proposed approach demonstrates EPA’s commitment to refining its processes in a way that is both protective and practical,” an official said in a press release.  “The proposal reflects meaningful progress toward a more science-driven regulatory framework for conducting TSCA risk evaluations.”

Comments on the proposed rule are due November 7, 2025.  More on the 2024 rule can be found here.

EPA Stands by CERCLA PFAS Designation Amid Legal Challenge

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EPA under the Trump administration will defend a rule issued by the Biden administration designating two PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the agency told the D.C. Circuit Court of Appeals on September 17, 2025.

“EPA has completed its review and has decided to keep the Rule in place,” the agency wrote in a court filing.

The case, Chamber of Commerce of the USA v. EPA, No. 24-1193, consolidates challenges to the May 2024 rule.  It has been held in abeyance since February at EPA’s request while the Trump administration determined how to proceed.

EPA’s decision to defend the rule is somewhat unexpected.  Last month, the New York Times reported that internal EPA documents recommended its repeal, stating that its “cons outweigh pros.”

Key Impacts of the CERCLA Designation

The rule has significant consequences for EPA’s ability to respond to contamination and assign cleanup responsibility for PFOA and PFOS, the two PFAS covered by the designation.

“Designating PFOA and PFOS as CERCLA hazardous substances eliminates barriers to timely cleanup of contaminated sites, enables EPA to shift responsibility for cleaning up certain sites from the Fund to [potentially responsible parties (PRPs)], and allows EPA to compel PRPs to address additional contaminated sites,” the rule states.

Due to the designation, entities that release PFOA and PFOS above reportable quantities must notify authorities.  When releases occur, EPA (and other agencies) can more quickly respond, because they no longer need to first determine that the release “may present an imminent and substantial danger.”

Crucially, the designation also allows EPA to compel PRPs to take action in response to significant PFOS or PFOA contamination—often at their own expense.

The rule justifies listing PFOA and PFOS based on their health hazards, persistence and mobility in the environment, and bioaccumulation in humans and other organisms.  EPA also conducted a “totality of the circumstances” analysis, which weighed the pros and cons of their designation.

More on EPA’s PFAS and CERCLA actions can be found on our CERCLA archive.

EPA to Fast-Track Chemical Reviews for AI and Data Center Projects

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EPA will prioritize review of premanufacture notices (PMNs) for chemicals tied to artificial intelligence (AI) and data center projects, the agency announced on September 18, 2025.

“We inherited a massive backlog of new chemical reviews from the Biden Administration which is getting in the way of projects as it pertains to data center and artificial intelligence projects,” EPA Administrator Lee Zeldin said.  “The Trump EPA wants to get out of the way and help speed up progress on these critical developments, as opposed to gumming up the works.”

The policy implements President Trump’s Executive Order 14318, “Accelerating Federal Permitting of Data Center Infrastructure,” which directs the agency to expedite permitting for qualifying projects under a variety of environmental statutes, including the Toxic Substances Control Act (TSCA).

What Projects are Eligible?

Two types of projects can qualify for expedited review:

  1. Data center projects requiring more than 100 megawatts (MW) of new load dedicated to AI inference, training, simulation, or synthetic data generation.
  2. Covered component projects, which include the materials, products, and infrastructure needed to build or operate such facilities—such as energy infrastructure, power plants, semiconductors, networking equipment, and data storage systems or software.

To be eligible, a project must also meet at least one of the following criteria:

  • A commitment of $500 million or more in capital expenditures.
  • An incremental electric load addition of more than 100 MW.
  • Direct relevance to national security.
  • Official designation as a qualifying project by a federal department.
How to Request Priority Review

According to updated EPA guidance, the new priority review process will take effect on September 29, 2025. To request it, PMN submitters must:

  • Attach a cover letter to their PMN submission via EPA’s Central Data Exchange (CDX).
  • Identify the specific data center or covered-component project the chemical will support.
  • Show that the project meets at least one of the executive order’s qualifying criteria.
  • Provide supporting documentation, such as permitting records, project announcements, or letters of support, plus details on how the chemical will be used.

EPA has posted detailed instructions for companies seeking priority review on its PMN guidance webpage.

EPA’s 2025 FIFRA Enforcement Trends

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EPA has maintained a surprisingly aggressive enforcement posture under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 2025, even as broader deregulatory and budget-cutting initiatives move forward.  Data from the first part of the year suggest that civil enforcement remains vigorous across multiple sectors and may be exceeding levels seen in previous years.

Key Enforcement Activity

Increased Volume of Cases:  EPA’s Enforcement and Compliance History Online (ECHO) database indicates that 84 FIFRA administrative enforcement cases with civil penalties were opened from February through July 2025.  This represents a notable increase compared to the same period in 2024 and 2023, when approximately 59 and 51 cases were issued, respectively.

Rising Penalties:  EPA’s enforcement in 2025 has produced some of the largest FIFRA settlements on record.  In May, Costco Wholesale Corp. agreed to a $3.07 million settlement for selling unregistered antimicrobial gloves and misbranded air filters, failing to file import notices, and violating a stop‑sale order.  As part of the same enforcement action, Winix America settled for more than $1 million.  A third seven-figure settlement was reached with Stepan Co. for selling or distributing a misbranded pesticide.

Notices of Refusal of Admission:  EPA Region 8 has been actively monitoring pesticide imports along the northern border.  EPA’s administrative enforcement dockets webpage indicates that nearly 50 notices of refusal of admission have been issued in 2025 so far.

FIFRA Expedited Settlement Agreement Pilot Program

A significant number of civil penalties have been assessed through EPA’s Expedited Settlement Agreement (ESA) Pilot Program under FIFRA, launched in January 2025.  The program targets minor, easily correctable violations and provides discounted, non-negotiable settlements, in lieu of formal enforcement.  The pilot program is intended to streamline enforcement while prioritizing resource efficiency and deterrence.

This pilot program will remain available for 36 months from its approval date, with evaluation of its effectiveness slated after 30 months.  ESA penalties have generally ranged from several hundred to several thousand dollars.

Implications for Regulated Entities
  • Enforcement focus remains strong on labeling, registration, import compliance, and antimicrobial products.
  • The ESA Pilot Program may allow expedited resolution but applies only to specific, low-severity violations.
  • Companies should continue to operate under the assumption that enforcement remains robust.
Practical Steps

To manage enforcement risk:

  • Review labeling, registration status, and marketing claims for all pesticide and antimicrobial products.
  • Confirm compliance with import documentation such as notices of arrival and relevant filings.
  • Strengthen supplier and private-label compliance monitoring.
  • Conduct a proactive self‑audit under EPA’s Audit Policy, especially if potential minor violations are identified.
  • Evaluate whether any matters may qualify for the FIFRA ESA Pilot Program.
Final Thought

Despite changes in the regulatory landscape, 2025 shows that EPA’s FIFRA enforcement remains serious.  Taking preemptive steps can provide meaningful protection and potentially reduce enforcement exposure.

EPA Requests Comment on Reconsideration of PCE Rule

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On July 30, 2025, EPA published a request for comment as it reconsiders its regulation of perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA).  The request marks the first step toward potentially amending the rule issued in December 2024, which prohibited or phased out most uses of the solvent.

EPA is particularly interested in receiving comment on:

  • Whether the existing chemical exposure limit of 0.14 parts per million (ppm) should be replaced by a different limit, such as the non-cancer exposure limit of 0.5 ppm or the lifetime cancer exposure limit of 0.47 ppm;
  • Conditions of use that may be better managed through workplace protections rather than bans; and
  • Use of PCE in industrial dry cleaning processes, including workplace controls and the performance of alternatives in those operations.

EPA first announced its intent to revisit the rule in a May 12 motion requesting that the Fifth Circuit place a consolidated legal challenge to the regulation on indefinite hold.  The court denied that request, instead granting a 90-day stay.

The PCE rule was primarily driven by concerns over the solvent’s neurotoxicity.  It bans all consumer uses of PCE as well as many industrial and commercial uses, including a 10-year phaseout for use in dry cleaning.  Many of the uses that are not prohibited, such as use in aircraft and petrochemical manufacturing, will be subject to workplace exposure controls.

According to EPA’s May 12 filing, any revisions to the rule are expected to take 12 to 18 months.  Comments on the notice are due August 29, 2025.

EPA Updates Safer Choice Program’s Ingredients List

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On July 21, 2025, EPA added 18 chemicals to the Safer Chemicals Ingredients List (SCIL).  The move may signal that the agency plans to continue the Safer Choice program, despite earlier speculation that the Trump administration might transition it to the private sector.

With the update, there are now 983 chemicals on the SCIL.  The list is designed to help manufacturers find safer alternatives to hazardous chemicals.  Products that meet the criteria of the Safer Choice program are eligible to carry the “Safer Choice” label.  The SCIL can be found here.

The voluntary program was targeted for elimination by the Heritage Foundation’s “Project 2025” initiative.  However, industry groups such as the American Cleaning Institute urged the Trump administration to retain it.

In a press release announcing the update, EPA states that the additions “support[] Administrator Zeldin’s commitment to transparency, innovation and safer chemistry.”  The agency also notes that using existing SCIL-listed chemicals can help companies avoid delays tied to the approval of new substances—an acknowledgment of industry concerns about the backlog in EPA’s review process.

“Without an approval from EPA under the Toxic Substances Control Act, new chemistries don’t make it to market, which simultaneously holds back the manufacturing and innovation sectors and keeps older chemistries in regulation,” the release states.

The 18 additions represent a variety of functional classes, including emollients, polymers, and surfactants.  All but one are either verified or expected to be of low concern based on experimental and modelled data.

The exception, sodium polyphosphates, is only allowed as an oxidant stabilizer due to possible hazards.  Its “yellow triangle” designation indicates that it is one of the safest chemicals available for its function, but that its function is in need of safer chemistry innovation.

Last year, EPA expanded the Safer Choice program by introducing sustainable packaging criteria and a Safer Choice Cleaning Service certification.  More on that update can be found here.