Court Orders EPA to Release PMNs in TSCA Transparency Case

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The D.C. District Court has ordered EPA to provide Toxic Substances Control Act (TSCA) premanufacture notices (PMNs) in litigation challenging the agency’s new chemical review procedures as insufficiently transparent.

The lawsuit, brought by five environmental groups, alleges that EPA fails to timely publish complete notices of receipt of PMNs and applications for test marketing exemptions (TMEs).  The groups also allege that the agency routinely violates TSCA by failing to make health and safety studies, safety data sheets (SDSs), and other information in PMNs publicly available, including information claimed as confidential business information (CBI) that facially does not qualify as CBI.

In August 2024, the court partially granted the plaintiffs’ motion to compel the administrative record.  However, EPA argued that the agency did not consider unredacted PMNs when it assembled public files, and that their contents would therefore shed no light on the agency’s decision-making.  The plaintiffs countered by arguing that the court already rejected those arguments when it partially granted the motion to compel and that the unredacted PMNs are necessary to determine whether EPA withheld test data or health and safety studies.

In an order filed December 24, 2025, the court agreed with the environmental groups.  “The court finds that Plaintiffs have carried their burden of showing that the unredacted versions of PMNs were ‘before the agency’ when the EPA assembled public files, notwithstanding the agency’s assertions that it did not rely on unredacted PMNs,” the order reads.

The order requires EPA to produce public versions of the PMN files by January 23, 2026, and unredacted versions under a protective order by March 23, 2026.

The case is Environmental Defense Fund v. Zeldin, No. 20-cv-00762 (D.D.C.).  A previous post on the case can be found here.

House Subcommittee to Hold Hearing on New TSCA Reform Bill

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On January 22, 2026, at 2pm ET, the House Energy and Commerce Committee’s Environment Subcommittee will hold a hearing to examine newly released Toxic Substances Control Act (TSCA) reform legislation.

The hearing, titled “Chemicals in Commerce: Legislative Proposal to Modernize America’s Chemical Safety Law, Strengthen Critical Supply Chains, and Grow Domestic Manufacturing,” will focus on a discussion draft released on January 15, 2026.  No witnesses are currently listed on the hearing webpage.

The discussion draft would make structural changes to key provisions of the statute, including revisions to TSCA section 4 testing requirements, section 5 new chemical reviews, and section 6 reviews of existing chemicals.  It would also reauthorize EPA’s authority to collect fees from manufacturers, which is set to expire later this year.

“Targeted and measured reforms [to TSCA] will increase accountability, strengthen domestic manufacturing, and safeguard the health and safety of our communities,” said House Energy and Commerce Committee Chairman Brett Guthrie (R-KY-02) and Environment Subcommittee Chairman Gary Palmer (R-AL-06) in a joint statement.

“The legislation we’ll be discussing in this hearing would support these goals and help to ensure TSCA processes are working effectively to evaluate chemical safety and support American innovation,” they added.

A livestream of the hearing will be available online.

House Science Committee to Hold January 8 Hearing on Chemical Regulation

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On January 8, 2026, at 10am ET, the House Committee on Science, Space, and Technology will hold a hearing entitled “Chemistry Competitiveness: Fueling Innovation and Streamlining Processes to Ensure Safety and Security.”

According to Inside EPA, the committee said in an announcement that the hearing will “examine the state of chemical research and development in the United States and how the regulatory environment affects progress.”  It comes after an October Senate Environment and Public Works Committee hearing on chemical regulation, which included substantial discussion regarding possible Toxic Substances Control Act (TSCA) reform.

The hearing will feature the following witnesses:

  • Charlotte Bertrand, Senior Director, Chemical Management, Regulatory Policy and Strategy, American Chemistry Council
  • Stan Meiburg, Former Acting Deputy Administrator, United States Environmental Protection Agency
  • Gwen Gross, Ph.D., Senior Technical Fellow, The Boeing Company
  • Keith Corkwell, Senior Vice President and President of Lubrizol Additives, The Lubrizol Corporation

A livestream of the hearing will be available on YouTube.

EuroChem Faces TSCA Lawsuit Over Alleged CDR Reporting Failures

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On December 15, 2025, the Center for Environmental Health (CEH) filed suit against EuroChem, alleging that the fertilizer giant failed to report billions of pounds of chemicals imported into the US between 2016 to 2019.

EPA’s Chemical Data Reporting (CDR) rule, promulgated under the Toxic Substances Control Act (TSCA), requires that manufacturers and importers report all chemicals manufactured or imported in volumes of 25,000 pounds or more per site per year.  According to CEH, EuroChem failed to submit CDR reports by the 2021 reporting deadline for at least nine chemicals that allegedly exceeded this threshold during the 2016–19 reporting period.

The chemicals at issue include ammonium nitrate and ammonium sulfate, which CEH claims “cause respiratory irritation if inhaled and can lead to serious health problems with significant exposure,” according to a press release announcing the lawsuit.  Another chemical, monoammonium phosphate, was allegedly imported in quantities of over 45 billion pounds in 2018 alone.

“Eurochem’s failure to report these imports undermines EPA’s efforts under TSCA to evaluate and address chemical risks,” the complaint reads.  “It also prevents the public from tracking the movement of unsafe chemicals in commerce as well as monitoring their presence in communities”

The lawsuit is the latest in a series of actions brought by CEH, which systematically cross-references publicly available import data with CDR submissions to identify potential violations.  According to the press release, CEH has settled with fourteen companies to date over their CDR omissions.

Chemium Settlement

In the press release, CEH also notes that it recently reached a settlement with Chemium International Corporation, a Texas-based chemical supplier, for similar alleged CDR violations.  According to CEH, Chemium submitted CDR reports to EPA for eight chemicals imported between 2016 and 2019 and agreed to conduct an internal audit.

A post discussing another recent CEH CDR settlement, with Wego Chemical Group, can be found here.

First TSCA CBI Claims Will Expire in 2026—Companies Should Prepare Now

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Companies with confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA) should mark their calendars—prompt action may soon be required to maintain their claims.  CBI claims asserted under amended TSCA will begin to expire in June 2026, and submitters must reassert their claims prior to expiration to prevent the public disclosure of commercially sensitive chemical information.

Update – January 7, 2026

On January 6, 2026, EPA published a Federal Register notice describing its intended process for implementing the statutory requirements governing CBI expirations and reassertions.  This post has been updated to reflect new information provided by EPA in the notice.

The notice states that “EPA expects to provide further guidance [on CBI claim expirations], to solicit and answer questions, and potentially to host a webinar with information on notices of expiration and instructions for requesting extensions.”

When Will My CBI Claim Expire?

In 2016, Congress passed the Lautenberg Amendments to TSCA, which overhauled the statute’s CBI provisions.  Under amended TSCA, most CBI claims—including claims for specific chemical identities—expire after ten years.  As a result, many CBI claims asserted in 2016 will expire in 2026.

Under TSCA section 14(e)(1)(B), the ten-year protection period starts when a submitter asserts a claim, not when the submitter provides substantiation.  Although substantiation is generally required at the time a claim is submitted, some submitters may have provided substantiation at a later date.  This is especially true of claims that were submitted soon after the statute was amended.  Submitters should therefore calculate expiration dates based on the date of assertion and note that claims might expire before the ten-year anniversary of their substantiation.

Expiration dates for some chemical identity CBI claims are available on the TSCA Inventory.

Update: EPA’s January 2026 notice clarifies that claims for specific chemical identities expire ten years from the date the first claim for that substance was asserted.  If a chemical identity is claimed as confidential by multiple companies, this may result in a claim expiring less than ten years after it was asserted by a subsequent submitter.

For example, if Company A asserted a CBI claim for a chemical identity in 2016, and Company B asserted a CBI claim for the same chemical identity in 2019, CBI protection for the chemical identity would expire in 2026—even though only seven years have passed since Company B asserted its claim.

At present, it is unclear whether EPA would provide CDX notice of the impending expiration to both companies or only to the submitter that asserted the first claim.  (Notice procedures are discussed below.)

What Do I Have to Do to Reassert and Re-Substantiate my CBI Claim?

Submitters may extend CBI claims for subsequent ten-year periods by submitting a request for extension to EPA.  Section 14(e)(2).  A request for extension must include substantiation and must be submitted to EPA at least 30 days before the claim is set to expire.  Section 14(e)(2)(B)(i).

The substantiation requirements for a request for extension are the same as those that apply when asserting a claim initially.  Under 40 CFR 703.7(g), submitters have the option to either submit new substantiation or rely on substantiation that was provided with the initial submission, certifying that the substantiation remains true and correct.

The CBI regulations require that claims be submitted through EPA’s Central Data Exchange (CDX).  40 CFR 703.5(f).  In a response to comments document from the 2023 rulemaking that developed those regulations, the agency indicated that it anticipated developing a new CDX reporting form for submitters to reassert expiring claims.  EPA’s CBI FAQ page, last updated in August 2025, continues to signal that an electronic reporting tool is planned.

In some cases, submitters may find that it is no longer necessary to maintain a CBI claim, or that the subject information is no longer eligible for CBI protections because it has become publicly available.

Update: In the January 2026 notice, EPA confirmed that it is currently developing a CDX reporting tool for requests for extension and expects to have the tool in place before the first claims expire.  If implementation is delayed, EPA instructs submitters to postpone submitting requests for extension until the tool becomes available.  The notice states that “EPA will not release any information subject to expiring claims until the notice and review requirements of section 14(e) are met.”

On a CBI expiration guidance webpage updated January 5, 2026, EPA added that it will not disclose information covered by a timely request for extension if the agency does not complete its review of the request before the expiration date.  Under section 14(g)(1)(D), “the information will continue to be protected until the review is complete and any applicable appeal period under section 14(g) has elapsed,” the webpage states.

Will EPA Provide Advance Notice of My CBI Claim’s Expiration?

Section 14(e)(2)(A) provides that EPA “shall provide to the person that asserted the claim a notice of the impending expiration of the period” at least sixty days before a CBI claim expires.  EPA will address this provision by publishing a list of TSCA submissions with expiring confidentiality claims on its website or other appropriate platform.  40 CFR 703.5(h)(3).  Submissions must be added at least 60 days prior to expiration, along with instructions for reasserting and substantiating expiring claims.

In the response to comments document, EPA asserted that “Section 14(e) does not specify that EPA must provide individual notice of claim expiration.”  Nonetheless, during the rulemaking the agency stated its intent to provide individual notice via CDX, which is authorized under 40 CFR 703.5(h)(2).

EPA’s CDX notification system is imperfect.  Submitters may miss CDX notifications if the contact information associated with CBI claims is outdated.  Companies should therefore review their TSCA submissions to assess whether contact information is current.  Companies may need to contact the CDX Helpdesk for assistance gaining access to submissions made by former employees.  This process may take several weeks if a company needs to create a new CDX account and get that account connected to filings submitted by a former employee.  If the original filing was submitted by an entity that was not part of the company at the time of the submission, additional steps may be required, such as filing a notice of transfer.  40 CFR 703.5(h)(1).  That said, EPA’s response to comments document indicated that companies will not need access to the original CDX submission to reassert claims.

In general, TSCA requires EPA to provide actual notice before disclosing information claimed as CBI, such as information covered by a denied CBI claim or a denied request for extension.  Section 14(g)(2).  However, the statute makes an exception for expired CBI.  Where no timely request for extension is submitted, TSCA does not require EPA to provide actual notice before disclosing expired CBI, provided EPA has given the 60-day notice described above.  Section 14(g)(2)(C)(iii)(II).  As a result, a company that does not receive a CDX notification and does not monitor EPA’s list of expiring claims may not learn that a CBI claim has expired until after the covered information has been publicly disclosed.

Update: EPA’s January 2026 notice reiterates that the agency anticipates providing notice of impending CBI claim expirations via CDX, “[a]lternatively, or in addition” to the website listing.  The notice also reflects EPA’s view that publication of the website listing satisfies the 60-day notice requirement in section 14(e)(2)(A).  Whether a court would agree that a website posting—as opposed to personal notice—is legally sufficient remains an open question.

The notice further affirms that a “notice of disclosure [is] not required where a CBI claim has expired and no person submitted a timely extension request following [a] timely notice of expiration.”  EPA also observes that some companies may have submitted information claimed as CBI outside of CDX, such as paper filings predating electronic filing requirements or physical material provided to EPA pursuant to a TSCA subpoena or inspection.

Considering that:

  • CDX contact information may be outdated;
  • CBI claims may have been made outside of CDX; and
  • It is unclear whether all companies with CBI claims for a specific chemical identity will be notified via CDX when the first claim expires;

It is highly advisable that companies regularly review EPA’s list of expiring claims, rather than relying solely on CDX notifications, to avoid inadvertent expiration of CBI protections.

Are Any CBI Claims Exempt from the Reassertion and Re-Substantiation Requirements?

Pursuant to section 14(e)(1)(A), no action is necessary to maintain CBI claims that are exempt from substantiation and review according to sections 14(c)(2) and 14(g).  These include claims for specific information describing manufacturing processes, marketing and sales information, information identifying suppliers or customers, and specific production volumes, among others.

This post is for informational purposes only and does not constitute legal advice.

EPA Moves to Dismiss Novel TSCA CBI Challenge as Untimely

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A lawsuit seeking to prevent EPA from disclosing chemical identity information under the Toxic Substances Control Act (TSCA) was not timely filed, the agency told the District Court for the Middle District of Georgia on November 24, 2025.

Plaintiff Burgess Pigment Co. filed suit after receiving a 2025 notification from EPA stating that the agency would soon make a specific chemical identity publicly available.  However, EPA argues that Burgess was actually required to file years earlier, when the agency first informed the company that the chemical identity was not entitled to confidential business information (CBI) protection.

At issue is TSCA section 14(g), which provides claimants 30 days to appeal a CBI denial after receiving notice from EPA.  According to the agency, that notice was provided in 2020, when EPA issued an initial determination denying CBI claims Burgess had made in its 2016 Chemical Data Reporting (CDR) submission.  The 2025 notification merely restated EPA’s earlier conclusion that the information was ineligible for CBI protection, the agency says.

“Allowing Burgess to challenge EPA’s determination five years later would not only undermine the statutory scheme contemplated by Congress, but it would also prove administratively unworkable,” EPA states in a memo accompanying its motion to dismiss.  “Such a rule would permit companies to restart the ‘30-day clock’ simply by asking EPA to protect the confidentiality of information that EPA has already decided is not entitled to confidentiality.”

According to EPA, after the initial determination, Burgess and EPA entered into a toll agreement to extend the 30-day deadline while the parties discussed the CBI denial.  EPA ultimately affirmed its determination in January 2022, which, the agency says, triggered a new 30-day appeal period ending in February 2022.

The 2025 notification was issued in response to Burgess’s 2024 CDR submission, which again asserted that the chemical identity was CBI.  EPA notes that it sent a similar notification in 2023 in response to Burgess’s 2020 CDR submission.

Nondiscretionary Duty

Even if the suit had been timely filed, EPA contends that there is no basis for Burgess’s claim.

The CBI denial resulted from Burgess’s failure to timely respond to the statutorily mandated 2017 Inventory Reset Rule, which required manufacturers to take affirmative steps to maintain existing CBI claims.  Because Burgess did not do so, EPA says that TSCA required EPA to make the chemical identity public.

“EPA had no discretion to choose not to move the chemical to the nonconfidential portion of the list,” the memo reads.  “EPA acted in accordance with its statutory directive, and it would have been inconsistent with TSCA for EPA to decline to move the chemical.”

Although Burgess later submitted materials intended to support confidentiality, EPA contends those efforts came too late.  “[W]hen Burgess belatedly attempted to seek confidentiality in 2020 and beyond, there was no longer a confidentiality claim because EPA had already determined the information was not confidential,” the agency says.

Burgess has argued that EPA continues to treat the chemical identity as confidential despite the notification letters.  EPA disputes that characterization, noting that although the chemical identity has not yet appeared on the nonconfidential TSCA Inventory, it is not being treated as CBI.

“If, for instance, EPA received a [Freedom of Information Act] request for the information in the years since the claim was denied, EPA would provide the chemical identity in response to that request,” the memo states.

APA Claims

EPA also argues that Burgess has no recourse outside of TSCA section 14.  The agency contends that Burgess’s Administrative Procedure Act (APA) arguments fail because the APA limits judicial review to “final agency action for which there is no other adequate remedy in court.”

“Because Burgess had an adequate remedy under TSCA, it may not pursue its claim under the APA,” the memo states.

The case is Burgess Pigment Co. v. U.S. Environmental Protection Agency, No. 5:25-cv-00309 (M.D. Ga.), filed July 18, 2025.  More information on the case is available in a previous post.  Burgess’s response to the motion to dismiss is due December 30, 2025.

Federal Legislation Introduced to Create PFAS Cause of Action

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On December 11, 2025, Senator Kirsten Gillibrand (D-NY) and Representative Madeleine Dean (D-PA-4) introduced the PFAS Accountability Act of 2025 (S.3460/H.R.6626).  The legislation would establish a federal cause of action and allow courts to award medical monitoring for persons exposed to PFAS.

In a press release announcing the bill, Senator Gillibrand stated: “For years, companies have knowingly manufactured toxic, carcinogenic chemicals that have devastated families and communities.  Those companies must be held accountable for their actions.”

Versions of the PFAS Accountability Act have been introduced in every Congress since 2018.  The legislation has never passed either chamber, however.

Cause of Action

If enacted, the PFAS Accountability Act would add a new section to the Toxic Substances Control Act (TSCA) titled “Individuals Exposed to Perfluoroalkyl And Polyfluoroalkyl Substances.”  The amendment would allow individuals who have been “significantly exposed to PFAS,” or have “reasonable grounds” to suspect significant exposure, to bring suit individually or as a class in any district court.

Claims could be brought against any person that:

  1. Engaged in any portion of a manufacturing process that created the PFAS to which the individual was significantly exposed; and
  2. Foresaw, or reasonably should have foreseen, that the creation or use of PFAS would result in human exposure.

The bill establishes rebuttable presumptions of “significant exposure.” An individual would be presumed to have been significantly exposed if:

  • The PFAS at issue was released into one or more areas where the individual would have been exposed for a cumulative period of at least one year; or
  • The individual submits testing results demonstrating the presence of the PFAS in their body.

If plaintiffs do not submit test results, defendants could rebut the presumption of significant exposure by offering test results conducted by an independent testing provider.

Medical Monitoring

The legislation would authorize courts to award medical monitoring for qualifying claimants if:

  1. The individual’s significant PFAS exposure resulted in an increased risk of developing disease;
  2. That increased risk provides a reasonable basis for additional or more frequent medical examinations; and
  3. Those examinations are effective in detecting a disease associated with PFAS exposure.

Where insufficient toxicological data exists to determine whether exposure resulted in an increased risk of disease, courts “may lower the standard for scientific proof” until such data exists.  Courts would also have authority to order studies to assess whether an increased risk of disease occurred.

Definition of PFAS

Notably, the bill defines PFAS as “a perfluoroalkyl or polyfluoroalkyl substance with at least 1 fully fluorinated carbon atom,” which is significantly broader than the definition used by EPA in the TSCA section 8(a)(7) PFAS reporting rule and the 2024 significant new use rule (SNUR) for inactive PFAS.

More information on the PFAS Accountability Act of 2025 can be found here.

EPA Enforcement Under Trump 2.0: What Regulated Industries Need to Know

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The Trump administration’s second term has brought notable changes to environmental enforcement priorities at the Environmental Protection Agency. Recent data shows a shift in the mix of enforcement actions, with changes to both agency resources and enforcement philosophy that chemical manufacturers and other regulated industries should understand.

Enforcement Activity: A Mixed Picture

Recent enforcement data shows divergent trends across different types of actions:

Civil Judicial Cases Down: In the administration’s first six months, the Justice Department initiated 14 lawsuits for environmental violations, compared to 42 in Trump’s first term and varying numbers under previous administrations, as reported by USA Today. By eight months, DOJ had initiated 9 major civil cases on behalf of EPA, compared to 46 in the same timeframe under Biden and 53 during the equivalent period in Trump’s first term, according to the Washington Post.

Settlements have also decreased. Through the first eight months, Justice completed 28 environmental enforcement cases, compared with 81 under Biden and 80 in the first Trump administration during the same period.

Administrative Actions Stable: EPA maintains that administrative enforcement actions—which handle smaller offenses without court involvement—have remained steady or increased. The agency’s administrative case metrics match or exceed past presidencies, according to EPA statements. According to figures EPA provided to Inside EPA, the agency concluded 126 national-priority civil enforcement cases between January 20 and May 7, 2025, up from 97 cases over the same period in 2024.

Criminal Enforcement Claims: EPA asserts it has opened more environmental criminal cases in its first six months than the Biden administration. However, publicly available data does not yet confirm this—the most recent criminal cases in public databases date to 2023, making independent verification difficult at present.

Long-Term Context: Civil judicial cases have trended downward for over a decade. The Obama administration filed 102 lawsuits in the first six months of its first term in 2009, representing the peak of this enforcement metric. Every subsequent administration has seen declines, partly reflecting resource constraints across multiple administrations.

Staffing and Resource Changes

EPA and DOJ enforcement offices are undergoing significant personnel changes. EPA’s Office of Enforcement and Compliance budget has decreased by approximately $200 million since 2011 (inflation-adjusted), with staffing reduced by over 500 employees across multiple administrations, USA Today reported. The current administration is pursuing a 23 percent staff reduction at EPA—approximately 4,000 positions.

The Department of Justice’s environmental enforcement section has also experienced staff reductions. Reports indicate the unit’s attorney count dropped from approximately 120 earlier in 2025 to an estimated 65-70 lawyers by mid-year.

The government shutdown in late 2025 temporarily furloughed approximately two-thirds of surveyed EPA enforcement staff, according to union data. These furloughs affected inspections and case work during the shutdown period.

Policy Changes and Enforcement Priorities

The administration has established new enforcement priorities through formal guidance:

Environmental Justice Considerations: A March 2025 EPA memo states that “environmental justice considerations shall no longer inform EPA’s enforcement and compliance assurance work.” The memo specifies that enforcers will not consider whether affected communities are overburdened or vulnerable when making enforcement decisions.

In a statement to USA Today, the EPA described this as promoting equal treatment, adding that the agency will “make sure that enforcement targets the worst pollution and threats to human health, wherever they occur.”

Energy Production: The March memo establishes that “enforcement and compliance assurance actions shall not shut down any stage of energy production (from exploration to distribution) or power generation absent an imminent and substantial threat to human health.”

Enforcement Philosophy: In its statement, EPA added that its current focus is on “efficiently resolving violations and achieving compliance as quickly as possible rather than pushing for broad injunctive relief that goes beyond what the law requires.” The agency also told the Washington Post that it is “focused on statutory obligations and Presidential priorities.”

EPA defends its approach by noting that “civil judicial complaints filed are not the best measure of law enforcement or compliance with environmental laws” and points to administrative and criminal metrics as better indicators of enforcement activity. The agency states: “A focus on quick return to compliance and addressing clear violations will increase efficiency and ensure that the Agency is accountable to the American people for every dollar spent.”

Targeted Regulatory Relief

The administration has pursued an aggressive deregulatory agenda through executive orders and agency actions. Key developments include:

  • Air Quality Standards: EPA recently moved to roll back stricter particulate matter standards implemented under Biden, arguing the previous administration exceeded its authority without sufficient review. The Biden-era standard lowered acceptable soot levels from 12 to 9 micrograms per cubic meter—a change EPA projected would prevent up to 4,500 premature deaths by 2032.
  • Water Protections: EPA released a proposal to dramatically narrow Clean Water Act protections, potentially stripping safeguards from between 38 and 70 million acres of wetlands and countless stream miles. The proposed rule would limit federal jurisdiction only to wetlands with surface water during the wet season that directly connect to continuously flowing water bodies.
  • Industry-Specific Relief: President Trump has issued proclamations granting two-year regulatory exemptions to facilities deemed vital to national security, including coke oven operations, copper smelters, coal plants, and certain chemical manufacturers. These facilities can comply with pre-Biden standards during this relief period.
  • TSCA Delays: EPA delayed the effective date of several Toxic Substances Control Act rules to March 2025, including the TCE risk management rule, providing additional time for regulatory review.
The FIFRA Exception

Notably, EPA enforcement under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has remained robust—and even intensified. As discussed in a previous post, from February through July 2025, EPA opened 84 FIFRA administrative enforcement cases with civil penalties, compared to 59 during the same period in 2024. Several 2025 FIFRA settlements rank among the largest on record.

This aggressive FIFRA enforcement continues despite broader budget cuts and deregulatory initiatives, suggesting pesticide compliance remains a priority focus area. EPA has also implemented an Expedited Settlement Agreement pilot program for minor FIFRA violations, offering discounted, non-negotiable settlements to streamline enforcement.

Strategic Implications for Compliance

The current enforcement environment presents several considerations for regulated entities:

Civil Judicial Enforcement: With fewer civil lawsuits being filed, companies face reduced likelihood of federal court actions in the near term.

Administrative Enforcement Continues: EPA maintains that administrative enforcement remains active and reportedly exceeds previous levels. These actions should not be underestimated—administrative penalties can reach high six- and low seven-figure amounts. Additional costs include attorneys’ fees, consultant expenses, and implementation of corrective measures. For product-based programs like TSCA, violations can result in loss of market access, stop-sale orders, and significant business disruption.

Alternative Enforcement Mechanisms:

State Enforcement: State agencies have primary enforcement authority for many environmental programs. However, many states have also experienced budget and staffing constraints in recent years, creating variability in state-level enforcement capacity.

Citizen Suits: Environmental statutes authorize private parties to bring enforcement actions. Organizations like the Environmental Integrity Project have filed federal lawsuits against industrial facilities for air and water violations. These citizen suits can result in penalties and requirements to install pollution controls.

Recent citizen suit examples include actions against petroleum coke plants in Louisiana, the Shell plastics plant in Pennsylvania, and food processing facilities for Clean Water Act violations.

Practical Considerations

For TSCA-regulated manufacturers and other chemical industry clients:

Compliance Planning: Environmental statutes and regulations remain in effect. Violations occurring now remain subject to administrative enforcement, citizen suits, and future enforcement actions. For TSCA matters, violations risk market access restrictions.

FIFRA Enforcement: Pesticide and antimicrobial enforcement remains robust, with an uptick in enforcement compared to 2024.

Alternative Enforcement: State agencies and citizen suits continue as enforcement mechanisms. Recent citizen suits have targeted petroleum coke plants, chemical facilities, and food processors.

Regulatory Relief: The administration has provided targeted relief including two-year exemptions for certain industrial facilities and delays of TSCA rule effective dates. Companies should evaluate whether their operations qualify.

Recommended Actions: Monitor regulatory developments, maintain compliance programs, document compliance efforts, assess citizen suit exposure, and consult counsel before operational changes.

This blog post is for informational purposes only and does not constitute legal advice.

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.