EPA to Reconsider TSCA Section 8(d) Reporting Rule

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On November 24, 2025, EPA announced that it will reconsider a December 2024 Toxic Substances Control Act (TSCA) rule requiring manufacturers of sixteen chemical substances to submit unpublished health and safety information to the agency.

In the press release, EPA said that it “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.”  However, “EPA is not considering changing the 16 chemicals named in the rule as part of this action.”

EPA also noted that it “anticipates taking appropriate action on the reporting deadline (May 22, 2026) associated with the current” rule.

On the same day, EPA asked the D.C. Circuit go continue holding a legal challenge to the rule in abeyance while the agency reconsiders the rule.  The court granted EPA’s motion on November 25, 2025.

A list of the sixteen chemical substances listed by the rule can be found in a previous post.

Current Requirements

The rule, promulgated under TSCA section 8(d), requires manufacturers that manufactured (or proposed to manufacture) any of the listed substances during a ten-year lookback period to submit copies of health and safety studies in their possession.  In addition, manufacturers currently manufacturing (or proposing to manufacture) any of the substances must submit lists of ongoing studies, initiated studies, studies that are known to the manufacturer but not in its possession, and studies previously submitted to a federal agency without confidentiality claims.

Studies previously submitted to EPA under TSCA are exempt.  However, the rule does not exempt companies that imported one of the substances in an article, companies that manufactured one of the substances only as a byproduct or impurity, or include a de minimis threshold.

EPA initially set March 13, 2025, as the reporting deadline for most submissions, but later extended the deadline twice. The current reporting deadline is May 22, 2026.

More information on the rule can be found here.

EPA Releases Default Values Guide for TSCA New Chemical Risk Assessments

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On November 24, 2025, EPA released a guide listing common “default values” for environmental releases and worker exposures used by the agency in risk assessments of new chemical substances under the Toxic Substances Control Act (TSCA).

What Are Default Values?

Default values are assumed engineering values used by EPA when chemical-specific information is unavailable.  For example, the guide shows that EPA assumes that 3% of a new chemical substance remains in a 55-gallon drum as residue if the drum is emptied by pumping, while 0.6% remains if it is emptied by pouring.

“This initiative marks another step forward in the agency’s ongoing commitment to transparency by providing valuable information to stakeholders involved in the review of new chemicals,” an EPA press release states.  “The publication of the default values is also expected to improve efficiency, reducing the likelihood that submissions need to be reworked or resubmitted.”

What’s Included

The guide includes default values used to model environmental releases the following situations:

  • Transferring liquid material to/from transport containers
  • Transferring solid material to/from transport containers
  • General industrial/commercial processes
  • Transferring solid materials (e.g., transferring/unloading/loading of solid powders)
  • Industrial/commercial use of coatings

The guide also includes default values used to model inhalation or dermal worker exposures from situations involving handling solids (e.g., raw materials or formulated products) or liquids containing the new chemical substance.

EPA provides two example situations demonstrating how the default values are applied to real-world scenarios, including how the assumptions change if submitters provide additional information.

In the press release, EPA said that it considers the guide to be an evolving document that may be updated in the future.  The guide, and other guidance for new chemical submissions, can be found at EPA’s New Chemicals Division Reference Library.

Union Says EPA’s New Chemicals Rule Fails Transparency Mandate Under TSCA

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EPA’s 2024 new chemicals procedural rule fails to satisfy Congress’s intent that Toxic Substances Control Act (TSCA) new chemical and significant new use reviews be transparent, a workers union told the Ninth Circuit on October 16, 2025.

In its opening brief, United Automobile, Aerospace & Agricultural Implement Workers of America (UAW) cites its own experience attempting to secure information about the health hazards facing employees in one of its bargaining units.  Although a UAW representative was told by the company that it was producing two new chemicals, he was unable to locate any information on them on ChemView, EPA’s database of new chemical information, the brief states.

“EPA’s disclosures about new chemicals do not routinely include…two key factual components – employer name and location – since the employer is not necessarily the submitter, the submitter’s name is often claimed as CBI, and facility location is not among the fields that can be searched in ChemView,” UAW states.

“Without access to information about who may produce a new chemical and where it may be manufactured, potentially exposed workers and their unions cannot – as a practical matter – engage with EPA before the Agency imposes occupational controls that may or may not adequately protect the workers,” which is their right under the National Labor Relations Act (NLRA), the brief reads.

UAW and other unions jointly raised these concerns in August 2023 comments on EPA’s proposed new chemicals procedural rule.  However, according to the brief, EPA completely ignored the comment during the rulemaking—a violation of the Administrative Procedure Act (APA), according to the brief.

Proposed Disclosure Requirements

In their 2023 comments, the unions proposed a mechanism through which EPA could mandate the disclosure of information to unions or workers, which they argue would preserve the information’s confidential status.

“EPA can require entities submitting new chemical or significant new use applications to notify their affected employees that they are submitting these applications and to make the applications, the health and safety studies submitted with the application, and any risk evaluations completed by EPA available to the employees and their unions upon request, contingent on the requester agreeing to confidentiality protections,” the comments state.

Reiterating arguments made in the comments, UAW’s brief contends that this process would not run afoul of TSCA section 14, which governs CBI protections: “While Section 14, like [Freedom of Information Act (FOIA)]  Exemption 4, allows EPA to withhold confidential information submitted to the federal government…neither Exemption 4 nor TSCA Section 14 prohibits EPA from mandating third party disclosure of CBI.”

UAW argues that unions and workers routinely enter into similar confidentiality agreements to access other sensitive information, like financial information about corporate profits.  The union also points to a 1985 Third Circuit decision, which it argues “directed OSHA to permit direct employee access to claimed trade secret information if the workers signed a confidentiality agreement” under OSHA’s Hazard Communication Standard.

Case Details

The suit is consolidated with other challenges to the 2024 new chemicals procedural rule brought by environmental groups.  As discussed in a previous post, those groups are arguing that the rule’s failure to categorically exempt new persistent, bioaccumulative, and toxic chemicals (PBTs) from certain expedited reviews violates TSCA.

The case is Alaska Community Action on Toxics v. EPA, No. 25-158 (9th Cir.), filed 1/10/2025.

EPA Issues Proposed Rule Adding Significant PFAS Reporting Exemptions

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As anticipated, EPA has published a proposed rule that would introduce several significant exemptions to the one-time PFAS reporting requirements under the Toxic Substances Control Act (TSCA) PFAS reporting rule.

The proposal, published November 13, 2025, follows significant industry criticism of the 2023 rule’s expansive scope.  EPA first signaled that it was considering narrowing the rule’s requirements in May of this year, when the agency delayed its implementation for the second time.

“The proposed changes to improve reporting regulations will support [EPA] Administrator [Lee] Zeldin’s ‘Powering the Great American Comeback’ initiative by reducing regulatory reporting burdens and providing greater regulatory certainty to industry, resulting in a net reduction in cost while ensuring that EPA receives the PFAS data that are most relevant to the agency,” the agency said in a press release accompanying the proposed rule.

What are the Proposed Exemptions?

EPA proposes to exempt the following categories from the PFAS reporting requirements:

  • PFAS manufactured (including imported) in mixtures or products at concentrations of 0.1% or lower
  • Imported articles
  • Byproducts not used for commercial purposes
  • Impurities
  • Research and development chemicals
  • Non-isolated intermediates

These exemptions are similar to those under the TSCA Chemical Data Reporting (CDR) rule, with the addition of the 0.1% de minimis exemption.

EPA is also proposing to eliminate the streamlined reporting form for article importers and R&D manufacturers because those entities would now be fully exempt under the proposed rule.  For the same reason, EPA would remove the alternative reporting deadline for small manufacturers that would exclusively report as article importers.

Changes to the Submission Period

EPA’s proposal would likely delay the start of the reporting period once again.  The current opening date is April 13, 2026, but under the proposed rule, the reporting window would begin 60 days after the final rule’s effective date.

If EPA issues a final rule in June 2026—as indicated by the Spring 2025 Unified Agenda—and the rule takes effect 30 days after publication, the reporting period would open in September 2026.  However, because the proposal was released a month earlier than the Unified Agenda projected, EPA may also finalize the rule ahead of schedule, potentially resulting in an earlier start date.

The proposal would also shorten the reporting window from six months to three months, with EPA claiming that submitters “have had adequate time to consider how they intend to comply with the rule.”

Statutory Basis

In the proposed rule, EPA argues that the exemptions would better align the regulation with TSCA section 8, which directs EPA to avoid duplicative reporting, minimize compliance costs on small manufacturers, and limit reporting obligations to persons likely to have relevant information.

EPA also cites TSCA section 2(c), which requires that EPA carry out the statute “in a reasonable and prudent manner” and to “consider the environmental, economic, and social impact of any action.”

At the same time, EPA notes that it may in the future determine that certain currently exempted information “is necessary to support particular regulatory actions.”

Comments on the proposed rule are due December 29, 2025.  More on the TSCA PFAS reporting rule can be found in our archive.

ACI Pushes Senate to Address EPA Bottlenecks in New Chemical Reviews

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In an October 23, 2025, letter to leaders of the Senate Environment and Public Works Committee and its Subcommittee on Chemical Safety, the American Cleaning Institute (ACI) called for “targeted changes” to the Toxic Substances Control Act (TSCA) to accelerate new chemical reviews under the statute.

“ACI members are experiencing considerable challenges with [EPA’s] ability to meet its statutory deadlines under [TSCA], namely, to review and make final determinations on new chemicals within 90 days,” hindering innovation and the development of more eco-friendly products, the letter reads.

ACI also asked the committee to consider the “adverse impact” of significant new use rules (SNURs), which it claims are being applied to restrict “most” new chemicals.

“EPA has taken this route as TSCA requires EPA to consider ‘reasonably foreseen’ uses in new chemical reviews,” ACI wrote.  “The lack of a clear definition in the TSCA for the term ‘reasonably foreseen’ has led EPA staff to take an overly conservative approach that focuses heavily on theoretical hazards instead of utilizing a risk-based approach that prioritizes the specific conditions of use provided by manufacturers about the intended use of new chemistries.”

Meanwhile, ACI’s general counsel, Douglas Troutman, has been nominated by President Trump to lead EPA’s Office of Chemical Safety and Pollution Prevention. The Senate Environment and Public Works Committee advanced his nomination to the full Senate on October 29, 2025, in a party-line vote.

PFAS Reporting Rule Update: OMB Clears Path for EPA to Ease Requirements

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EPA is a step closer to easing PFAS reporting requirements for manufacturers and importers after the Office of Management and Budget (OMB) completed its review of a proposed rule on October 24, 2025, that is likely to introduce exemptions.

Background: The Current PFAS Reporting Rule

The Toxic Substances Control Act (TSCA) section 8(a)(7) PFAS reporting rule, finalized in 2023, requires entities that manufactured or imported PFAS in any year from 2011–2022 to report extensive data to EPA.  Unlike other TSCA reporting obligations, the rule does not exempt articles, de minimis quantities, byproducts, or impurities—drawing criticism from industry groups, who argue that its broad scope is both unnecessary and overly burdensome.

As discussed in a previous post, the rule’s original 2024 reporting deadline has already been delayed twice to 2026 because of technical difficulties.  However, in the most recent postponement, EPA signaled that it was considering reopening elements of the rule to align with the Trump administration’s deregulatory agenda.  On August 29, 2025, it submitted the proposal to OMB for regulatory review.

What’s Next

According to the Spring 2025 Unified Agenda, the rulemaking will incorporate “certain exemptions and other modifications to the scope of the reporting rule.”  The proposed rule is expected in December 2025, and EPA plans to finalize the rulemaking in June 2026.

More on the PFAS reporting rule’s requirements can be found in a previous post.

Groups Challenge EPA Rule Allowing PBTs in TSCA Exemption Reviews

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New persistent, bioaccumulative, and toxic chemicals (PBTs) should not be eligible for expedited reviews under the Toxic Substances Control Act (TSCA) known as the low volume exemption (LVE) and low releases and exposures exemption (LoREX), environmental groups told the Ninth Circuit on October 17, 2025.

The lawsuit challenges EPA regulations finalized in December 2024 that allow companies to continue to continue to apply those exemptions for certain PBTs.  In their opening brief, the petitioners argue that the rule violates TSCA’s requirement that exemptions protect against unreasonable risk.

“The record, including EPA’s own findings, establishes that the category of new PBTs may—indeed, will likely—present unreasonable risk even when complying with the terms of the LVE and LoREX Exemptions,” the brief states.

Disputed Eligibility Standards

The 2024 rule made PFAS categorically ineligible for the exemptions, as well as PBTs “with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms.”  The petitioners contend that this “turns the statute on its head” because it requires that EPA affirmatively determine “that a specific PBT is unsafe” for it to be ineligible.

“In effect, the rule treats an absence of evidence as a reason to expedite the approval of a new PBT chemical, rather than a reason to deny an exemption application,” their brief states.

EPA justified its decision to allow certain PBTs to remain eligible by suggesting that PBT use may not always result in exposure, “such as chemical substances used in a closed system to make semiconductors.”  In the rule, EPA also stated that it “expects that most exemptions for PBT chemical substances will not be granted.”

The petitioners, however, describe EPA’s “zero-release-zero-exposure” scenarios as “fanciful.”   All “new PBTs will eventually be released into the environment, cause exposures, and thereby result in serious injury,” they argue.

Speedier Reviews

LVE and LoREX applications are subject to a 30 day review period, compared to 90-to-180 days for standard reviews, though review backlogs mean reviews often take much longer in practice.  The petitioners claim that LVE and LoREX reviews are less “detailed and comprehensive” than standard reviews, and observe that EPA does not require testing or impose additional restrictions on approved exemption applications—incentivizing companies to use them.

Publicly available EPA data shows that 221 valid LVEs were submitted in fiscal year 2025, which was greater than the number of standard review applications.  No LoREX submissions were received during the year, however.

In August 2025, EPA announced that it had made substantial progress on the LVE backlog thanks to process improvements.  However, its continued progress may be jeopardized by the ongoing government shutdown.

More on EPA’s 2024 new chemicals procedural rule can be found in a previous post.  The case is Alaska Community Action on Toxics v. EPA, No. 25-158 (9th Cir.), filed 1/10/2025.

EPW to Hold October 23 Hearing on Chemical Regulation

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The Senate Committee on Environment and Public Works (EPW) will hold a hearing on chemical regulation this week, offering potential insight into Toxic Substances Control Act (TSCA) reform legislation reportedly being developed in the Senate.

The hearing, titled “Examining the Beneficial Use and Regulation of Chemicals,” is scheduled for 10:30am on October 23, 2025.  It will be convened by EPW’s Chemical Safety Subcommittee, which is chaired by Senator John Curtis (R-Utah).

According to EPW’s website, the hearing will include the following panelists:

  • Peter Huntsman, President and CEO of Huntsman Corporation, a chemical manufacturer.
  • Gwen Gross, Senior Technical Fellow at The Boeing Company.
  • Tracey Woodruff, Professor and Director of the Program on Reproductive Health and the Environment at the University of California, San Francisco. Dr. Woodruff previously worked as a scientist at EPA.

The hearing was originally scheduled for July but was postponed.

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.

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.