Manufacturer Challenges Court-Ordered CBI Disclosure

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A specialty materials manufacturer is suing EPA to prevent the release of its unredacted premanufacture notices (PMNs) under seal in separate litigation challenging the transparency of EPA’s new chemicals program under the Toxic Substances Control Act (TSCA).

A March 23, 2026, court deadline for EPA to produce the documents has now passed without EPA compliance, as the agency, environmental groups, and the manufacturer battle over the appropriate course of action.

The five environmental groups brought the original suit in 2020, alleging that EPA violates TSCA by withholding certain information from the public and allowing overly broad confidential business information (CBI) claims.  In December 2025, over EPA’s objections, the D.C. District Court ordered the agency to produce unredacted PMNs under a protective order as part of the administrative record.

Arkema, Inc. submitted two of those 84 PMNs.  After EPA notified the company of the impending disclosure, Arkema filed suit on March 13, 2026, to block it.

While TSCA allows EPA to disclose CBI as required by a court order, Arkema argues that the scope of the disclosure encompasses information beyond what is at issue in the case.  EPA’s failure “to narrow appropriately the scope of CBI disclosures to only those necessary and related to the claims at issue is both arbitrary and capricious,” the complaint states.

Arkema further contends that “the terms of the protective order are insufficiently protective of proprietary information” and impose “substantially less stringent requirements than EPA itself requires to protect CBI” because they lack provisions for safe storage and handling, training, designated work areas, limits on the number of recipients, a central oversight contact, or recourse for inadvertent disclosures.

Arkema’s suit prompted EPA to move for a stay of the disclosure order on March 17.  While “Arkema seeks relief only as to the information that it claims is CBI,” EPA argues that the lawsuit implicates all CBI-designated materials at issue in the case.  In addition, the agency warns that allowing separate production of Arkema’s PMNs could inadvertently reveal which PMNs belong to Arkema and thereby compromise its CBI claim.

Environmentalists’ Response

In a March 19 response, the plaintiffs argue that Arkema’s suit and EPA’s motion are a delay tactic in the long-running litigation.

EPA should never have notified Arkema of the impending disclosure, the plaintiffs contend, because multiple statutory notification exceptions apply.  Under the plaintiffs’ reading of TSCA, notification is a precondition to filing suit—meaning there is “no basis for” the new challenge.

This “should have been evident to EPA,” the plaintiffs allege.  “Nevertheless, EPA voluntarily sent a letter to Arkema incorrectly stating they had a right to appeal….Now that a single manufacturer has submitted such an appeal, EPA turns around and asks this Court yet again to halt production of all 84” contested PMNs, not just Arkema’s.

If EPA believed that a manufacturer could challenge the disclosure and enjoin EPA from complying with the court’s order, it should have said so, the plaintiffs argue.  “Instead, it remained silent, thereby inviting the current procedural mess.”

Nor has EPA met its burden to receive its requested relief, since it has not alleged any hardship, the response continues.  And despite the company’s CBI claims, the plaintiffs note that it may already be apparent which of the sanitized PMNs—already provided to the court—belong to Arkema: one contains an attached safety data sheet identifying the company by name, and another includes “a number of documents with Arkema’s letter head.”

The plaintiffs further argue that six years of media coverage make it implausible Arkema was unaware its PMNs might be disclosed, alleging the company “has slept on its rights.”  Arkema “never claims that it did not know of this lawsuit or the potential implications for its PMNs, but instead has carefully worded its allegations” to say only that it was never informed of active discussions about the scope and terms of releasing its CBI.

EPA’s Reply

In a March 20 reply, EPA says it is agreeable to the environmental groups’ suggestion that the parties meet and confer about potential consolidation or modification of the protective order to address Arkema’s concerns.  But EPA reiterates its request for a stay, arguing that the agency “is caught in an untenable situation” that demonstrates “clear hardship.”

“Requiring EPA to produce any of the unredacted PMNs would prematurely decide Arkema before the parties (EPA, Plaintiffs, and Arkema) have an opportunity to resolve the competing positions and defeat the purpose of coordination and possible consolidation or modifications to the protective order,” the reply states.

EPA contends its disclosure notifications to Arkema and other companies were required, arguing that none of the statutory exemptions apply.  The agency also notes that, due to difficulties confirming receipt, a subset of companies are still within TSCA’s 30-day window—triggered by notification—to file suit to enjoin disclosure.

EPA further argues that whether it can selectively withhold only Arkema’s PMNs is a legal question that should be resolved in the new litigation.  “Until the parties or the Court resolve that legal question, EPA proceeds cautiously,” the reply states, citing TSCA provisions imposing criminal penalties for wrongful CBI disclosures.

On March 25, the environmental groups notified the court that EPA failed to produce the unredacted PMNs by the March 23 deadline.

The case is Arkema Inc. v. EPA, No. 26-cv-886 (D.D.C.).  The underlying case is Environmental Defense Fund v. Zeldin, No. 20-cv-762 (D.D.C.).

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.

SBA Calls for Federal Scrutiny of State EPR Laws

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In comments submitted October 30, 2025, the Small Business Administration’s (SBA’s) Office of Advocacy is calling for the federal government to take action against state extended producer responsibility (EPR) programs “as barriers to interstate commerce.”

SBA’s comments are part of a larger document submitted in response to an August 2025 Department of Justice (DOJ) request for information on state laws that may adversely affect the national economy.  The agency highlights EPR programs’ fees and complexity, which SBA argues disproportionately burden small businesses.

Oregon’s EPR Program

SBA directs much of its criticism on Oregon’s EPR program for packaging, paper, and serviceware, which it describes as especially burdensome.

The law’s broad definition of “producers,” which includes wholesalers and distributors, affects businesses “who have no control over packaging design,” SBA writes.  In addition, while many state EPR laws require producers to join a producer responsibility organization (PRO) that collects fees and administers the program, SBA contends that Oregon’s PRO structure is monopolistic.

“Unlike traditional EPR programs that target specific products with transparent fees, Oregon’s system delegates vast regulatory authority to a single private entity, the Circular Action Alliance (CAA), which operates with a confidential fee methodology and minimal oversight,” the comments state.

SBA’s recommendations extend beyond Oregon, however.  The agency advocates for EPR laws to be struck down, calls for a Federal Trade Commission (FTC) investigation into whether PRO fees violate federal antitrust laws, and urges greater fee transparency and state oversight.

“Most importantly, other states should avoid Oregon’s model of delegating broad regulatory power to private monopolistic entities without adequate procedural protections,” SBA writes.  “Future EPR legislation should maintain direct state oversight, provide competitive alternatives to single PROs, and ensure that compliance costs are proportionate to businesses’ actual control over packaging decisions and ability to bear regulatory burdens.”

Addressing State Inconsistencies

Other commenters echoed concerns about the economic impacts of EPR laws, emphasizing inconsistencies among state programs.  The American Chemistry Council (ACC), the American Institute for Packaging and the Environment (AMERIPEN), and the National Restaurant Association all cited conflicting definitions, requirements, and program structures as drivers of cost and compliance challenges.

Notably, in its September 15 comments, ACC suggested that a federal EPR program may be the solution to these difficulties.  “EPA could establish a federal framework that promotes a common approach to EPR and recycling,” ACC stated.  “Setting common definitions, metrics, and data collection standards, could support compliance and stimulate the domestic economy.”

ACC also urged federal preemption of other state chemical restrictions, including PFAS laws and California’s Proposition 65.

The docket for DOJ’s request for information is available 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.

Court Finds EPA’s Transparency in New Chemicals Disclosures Reviewable

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EPA’s alleged failure to disclose certain information submitted to its New Chemicals Program is subject to judicial review under the Toxic Substances Control Act (TSCA) and the Administrative Procedure Act (APA), the D.C. District Court ruled on August 20, 2024.

In Environmental Defense Fund v. Regan,  No. 1:20-cv-00762-LLA, five environmental organizations allege that EPA engages in a pattern or practice of violating TSCA’s disclosure requirements for premanufacture notices (PMNs) and applications for test marketing exemptions (TMEs).  The suit’s 10 counts include allegations that EPA failed to publish timely and complete notices of receipt of PMNs; failed to make health and safety studies, safety data sheets, and other information contained in PMN submissions available for examination; and failed to disclose information claimed as confidential business information when it facially did not qualify as confidential.

EPA moved for judgment on the pleadings, asserting that the plaintiffs are barred from seeking relief under TSCA for most of their claims.  While TSCA’s citizen suit provisions allow persons to compel the agency to perform nondiscretionary duties, EPA argued that the relevant statutory and regulatory provisions “do not impose a date-certain deadline” on EPA.  The agency also argued that judicial review under the APA would be inappropriate because the claims concern activities that are interlocutory in nature and too minor to meet the APA’s threshold for “agency action.”

The court denied EPA’s motion.  Even in instances where TSCA does not set an explicit deadline, the court said that it is sometimes apparent that activities must be taken in relation to other events.  Three of the plaintiffs’ 10 counts were found to fall in this category.  For example, TSCA directs EPA to provide immediate notice of TME applications for public input and requires EPA to make a determination on each application within 45 days.  Since “[n]otice must precede comment” and “comment must precede the EPA’s decision,” “[t]he only logical conclusion” is that notice is required prior to expiration of the 45-day period, the court held.

For the seven remaining allegations—which all concerned the availability of information submitted with a new chemical notification, and for which a deadline for agency disclosure to interested parties could not be ascertained from the statutory structure—the court was unconvinced by EPA’s argument that the APA could not offer relief.  The APA’s definition of agency action has been interpreted expansively by the courts, and the fact that the challenged activities are merely “interim steps” is not dispositive, the decision states.  Importantly, as part of this analysis, the court held that TSCA section 5(b) creates a “freestanding right to information” submitted as part of a new chemical notification.

Judge Loren L. AliKhan also granted the plaintiffs’ motion to compel the administrative record, rejecting EPA’s arguments that the claims should be understood as “failures to act” rather than actions—meaning that they would not have an administrative record.  However, she did not go so far as to agree with the plaintiffs on the merits.

According to EPA, since the case was filed in 2020, the agency has made “substantial and ongoing improvements to its practices for preparing and publishing public notices and public files as part of its ongoing commitment to improving the administration and transparency” of its New Chemicals Program.

In addition to the Environmental Defense Fund, the plaintiffs include the Center for Environmental Health, the Environmental Health Strategy Center, the Natural Resources Defense Council, and the Sierra Club.

EPA Releases PFAS Analytic Tools

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On January 5, EPA released its PFAS Analytic Tools database, a collection of PFAS information the Agency has brought together from internal Agency databases, other federal agencies, and state and tribal agencies. The data will be particularly useful to the Agency when it reviews submissions on  PFAS releases from the Toxics Release Inventory (“TRI”) reporting.  In addition, EPA expects that the database will benefit state, local, and tribal governments in navigating the PFAS-related requirements they are subject to.  The Agency also expects that the database will help communities gain a better understanding of local PFAS releases.

The database has 11 tabs that include:

  • An integrated map,
  • Drinking water contamination, production,
  • Wastewater and/or stormwater discharge monitoring,
  • Superfund sites,
  • Industry sectors in which PFASs were manufactured or used as raw materials, and
  • toxic releases.

In its press release on the database and on the database interface itself, the Agency identifies several data gaps. For example, the drinking water Unregulated Contaminant Monitoring Rule (“UCMR”) data was collected only between 2012 and 2015. EPA notes that state agencies and public water systems may have better data on PFAS levels in drinking water. Additionally, only a few states have set PFAS effluent limits for National Pollutant Discharge Elimination System (“NPDES”) permit holders, causing significant gaps in discharge monitoring. (The Agency has initiated rulemaking to increase monitoring effluent for PFAS.

Each tab identifies relevant data gaps and limitations.

The Agency is taking steps to fill these data gaps, including:

  • Initiating rulemaking to increase monitoring effluent for PFAS;
  • Publishing the fifth Unregulated Contaminant Monitoring Rule, which will significantly increase the number of drinking water samples collected by regulated entities (EPA predicts the number of samples collected will be in the millions);
  • EPA’s proposal to designate PFAS as hazardous substances under CERCLA; and
  • EPA’s recent proposal to change PFAS reporting requirements in the TRI data collection.

EPA recently held a webinar introducing the database and demonstrating its use.  A recording of the webinar is available here. A copy of the Agency’s presentation is available here.

EPA Updates New Chemical Review Program Webpage to Increase Transparency

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In December 2022, EPA announced updates to its New Chemicals Review Program website to include additional information and metrics on the Agency’s review of new chemicals and significant new uses.  In the announcement, the Agency stressed its commitment to increasing efficiency, effectiveness, and transparency through the chemical review process. To progress in this goal, the website will now include:

  • A more detailed breakdown of new chemical submissions, including a month-by-month count of new chemical submissions, completed risk assessments, and completed risk management actions for all notices and exemptions.
  • Greater details and explanations on each step of the review process. This includes “the extent to which the submitter has provided additional information during the review period – subsequent to the original submission – and the level of effort needed to potentially rework some or all of the risk assessment as a result” and applicability of new approaches developed by the Agency to standardize reviews for certain new chemicals.
  • A status tracker for new chemical exemptions (e.g., Low Volume Exemptions (LVEs) and Test Market Exemptions (TMEs)).

According to EPA, the new website will be updated monthly.

California Department of Toxic Substances Hosted Engagement Sessions on Sustainable Chemistry Definition

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The California Department of Toxic Substances Control (CDTSC) hosted two engagement sessions encouraging stakeholders to share their perspectives on an actionable definition of sustainable chemistry that was provided by the Expert Committee on Sustainable Chemistry (ECOSChem). ECOSChem is a 20-person group including representatives from academia, government, industry, and non-governmental organizations.  The group has been tasked with establishing “an ambitious, actionable definition and criteria for sustainable chemistry that can enable effective government policy, inform business and investor decision making, enhance chemistry education, and spur the adoption across all supply chains of chemicals that are safer and more sustainable.”

In its draft, ECOSChem defined sustainable chemistry as “the practice and application of chemistry that eliminates negative impacts to humans and ecosystems, as well as benefits current and future generations.” The definition was drafted with five criteria in mind (1) health and safety through hazard elimination, (2) climate and ecosystem impacts, (3) circularity, (4) equity and justice, and (5) transparency. In addition to the definition, , ECOSChem provided the following indicators of what sustainable chemistry will look like:

A sustainable chemical, material, process, or product will…

  • Eliminate all associated hazards and hazardous emissions to all people and ecosystems across its existence.
  • Not result in releases, including releases of byproducts or breakdown products, that negatively persist or bioaccumulate.
  • Eliminate impacts on climate and biodiversity by utilizing earth-abundant, non-toxic chemical building blocks that minimize habitat and resource degradation, greenhouse gas emissions, carbon footprints, and energy consumption, including for transportation and distribution.
  • Be designed to have [a] lifetime appropriate for its use and enable safe reuse and non-toxic recycling.
  • Prioritize resource and energy conservation and reclamation, reduce consumption of finite resources, and waste prevention, minimization, and elimination.
  • Be designed such that all associated negative social impacts are eliminated.
  • Be made or implemented to prioritize the remediation of harms for communities and societies that have been disproportionately impacted by traditional chemistries, chemicals, and chemical processes, and/or support the needs of workers, marginalized groups (e.g., immigrant communities, and communities of color), and vulnerable groups (e.g., pregnant women and children).
  • Be made or implemented in a way that does not create new problems or shift harm to other communities or societies.
  • Have had its health, safety, and environmental data disclosed in an accessible format to individuals, workers, communities, policymakers, and the public.
  • Use independent, third-party systems to verify sustainability, health, safety, and other claims. The sources for verification should be openly accessible.

ECOSChem members will use the feedback received at the meeting to revise the definition to ensure that the language is clear and actionable.

 

 

 

 

EPA Implements Collaborative Research Program to Support PMN Reviews

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On February 24, EPA announced a new effort “to modernize the process and bring innovative science to the review of new chemicals.”  In addition, the effort is expected to “increase the transparency of the human health and ecological risk assessment process.”  The Office of Chemical Safety and Pollution Prevention (OCSPP) is collaborating on this effort with the Agency’s Office of Research and Development (ORD) and other federal entities including the National Toxicology Program at the National Institute of Environmental Health Sciences.

The draft Strengthening the Science and Process to Evaluate New Chemicals Under TSCA; TSCA New Chemicals Collaborative Research Program: Problem Statement, Vision and Action Plan was released for public comment on March 9.  Written comments will be accepted through April 26, 2022.  In addition, stakeholders may comment at a virtual public meeting on April 20 and 21, 2022.  Instructions for registering for the meeting are available here.

EPA explains that the Collaborative Research Program (CRP) “will refine existing approaches and develop and implement new approach methodologies (NAMs) to ensure the best available science is used in TSCA new chemical evaluations.”  Components of this effort include:

  • Updating the methodology for using data from analogous chemicals to determine potential risks from new chemicals where health effects data on the new substance are not available.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics.
  • Developing a decision support tool to integrate the information streams used in new chemical risk assessments into a final risk assessment.

The docket for this effort is EPA-HQ-OPPT-2022-0218.