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.

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.

D.C. Circuit Rejects Environmentalist Arguments, Sides with Industry over TSCA CBI Rule

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EPA’s 2023 rule revising confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA) is only unlawful insofar as it could lead to certain inadvertent waivers of confidentiality by downstream entities, the D.C. Circuit ruled on December 20, 2024.

The case, Environmental Defense Fund v. EPA, No. 23-01166, consolidated petitions from the Environmental Defense Fund (EDF) and the American Chemistry Council (ACC).  EDF’s arguments in favor of narrower confidentiality protections were rejected by the court, whose ruling leaves EPA’s CBI rule largely intact.

However, the court agreed with ACC’s challenge to a provision in the rule that allowed downstream entities to waive CBI protections put in place by the upstream manufacturer when reporting information to EPA.  Specifically, ACC argued that the rule’s requirement that downstream entities assert and substantiate confidentiality claims for chemical identities reported via an “accession number” is arbitrary and capricious.  Under the CBI rule, if “any submitting entity fails to substantiate a confidentiality claim for a chemical identity…the chemical identity is no longer entitled to confidential treatment.”

Accession numbers are non-confidential identifiers assigned to chemicals whose identities are claimed as CBI.  Downstream entities reporting information to EPA using an accession number may have no knowledge of the chemical’s actual identity, the court noted, and may not have any incentive to keep it secret.  Nor would they necessarily have the information needed to adequately substantiate a claim, the opinion continues.

“This regulatory scheme cannot be squared with the commands of the statute, which require EPA to protect from disclosure chemical identities for which CBI claims have been properly assessed,” the court held, vacating the CBI rule “to the extent it allows for the unlawful disclosure of confidential information.”

Key Provisions are “Best Reading”

EDF challenged three provisions of the CBI rule.  The court rejected these challenges, explaining that EPA’s positions were  consistent with the “best reading” of the statute—the new legal framework adopted by the Supreme Court in Loper Bright v. Raimondo, the decision that struck down Chevron deference.

EDF argued that the rule’s use of “permissive” language and revised timeframe for when a CBI claim must first be substantiated were arbitrary and capricious.  However, the court found that the CBI rule sufficiently justified why those changes were necessary.  The permissive language at issue included a provision allowing EPA discretion in whether to disclose information that has lost CBI protection, unlike earlier regulations requiring its immediate and automatic release.

EDF also challenged the scope of the CBI rule’s definition of a “health and safety study,” which are statutorily ineligible for CBI protection.  EDF contended that the definition should include the entirety of any written report submitted to EPA that presents findings of a health and safety study, including information like the identity of the company submitting the report and the name of the lab that conducted the study—information which is currently eligible for CBI protection.  The court disagreed, holding that the statutory definition of health and safety study “suggest[s] that the term refers only to the evaluation of a chemical’s health and environmental effects, not the entire document containing that evaluation.”

More on the CBI rule can be found in a previous blog post.  An earlier post on this case, written after EDF filed its statement of issues, can be found here.

Environmental Group Petitions for Review of EPA’s New Confidential Business Information Rule

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On June 29, 2023, the Environmental Defense Fund (EDF), a non-profit organization, filed a petition in the US Court of Appeals for the District of Columbia requesting a review of EPA’s recently finalized rule Confidential Business Information Claims Under the Toxic Substances Control Act (TSCA) (88 FR 37155).  As described in a previous Verdant Law blog post, the final rule implements new requirements for the assertion and treatment of TSCA confidential business information (CBI) claims in light of the Lautenberg Amendments to TSCA.

In a non-binding statement of issues filed August 21, EDF listed the following as preliminary issues to be raised in the petition: whether the final rule is arbitrary, capricious, an abuse of discretion, or otherwise contrary to law because…

  1. It would allow submitters to assert CBI claims to shield the information from the public that TSCA makes categorically ineligible for CBI protection;
  2. It would not require substantiation or EPA review of a CBI claim that was asserted before a chemical’s commercialization for specific chemical identity once the chemical is commercialized;
  3. It unlawfully adopts a regulatory definition of “health and safety study” that is narrower than the TSCA definition, denying TSCA-mandated public access to important information on chemicals;
  4. The Agency purports to give itself unlawfully broad discretion through its regulations where TSCA imposes a duty upon the Agency; or because
  5. It reduces the transparency previously required under EPA’s CBI review procedures without adequate justification.

Briefs have not yet been filed, and EDF did not file a memorandum detailing its positions, so no additional information on EDF’s positions is currently available.

EPA Finalizes TSCA CBI Rule

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On June 7, 2023, EPA finalized a rule (88 Fed. Reg. 37155) that puts forth new and amended requirements for parties asserting confidential business information (“CBI”) claims under the Toxic Substances Control Act (“TSCA”). The new rule details specific procedures for the regulated community to submit and support CBI claims and for the Agency to review CBI claims and communicate their determinations to submitters. Additionally, the rule reorganizes existing provisions of the CBI regulations.

The following are the most substantial changes to procedures for submitting and supporting CBI claims under TSCA:

Substantiation Requirements Applicable at Time of Submission

The rule requires that confidentiality claims be asserted and substantiated at the time of submission; substantiation data requires submissions of supporting statements and certification, including but not limited to asserting that the party has taken reasonable measures to protect the confidentiality of the information, and a reasonable basis to believe that the information is not readily available through reverse engineering. (40 CFR 703.5(a)).

Supporting Statement and Certification

Certification of CBI claims is required at the times the statements are submitted.  Submitters will be required to answer a number of questions, many or all of which have been used for some time in EPA’s CBI substantiation templates and certain CDX submissions (e.g., CDR).  Submitters should note that certifications are submitted under penalty of perjury; any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.

Electronic Reporting

The final rule mandates that short of very limited exceptions, all CBI claims must be submitted electronically. This requirement is detailed in 40 CFR 703.5(f). Parties should be particularly conscious of this with TSCA Section 8(e) reporting, notifications under TSCA Section 12(b), and polymer exemption notices under TSCA Section 5 because this rule is the first mandating these types of reporting are to be done electronically.

Requirement to Report Health and Safety Information Using Organization for Economic Cooperation and Development (“OECD”) Harmonized Templates

Under the final rule, health and safety information must be provided using OECD harmonized templates. This is in addition to existing requirements that require submitters to provide a full study report. According to the Federal Register notice, the Agency will elaborate on instructions for including OECD harmonized template files (e.g., currently acceptable file types and IUCLID software versions). This requirement can be found at 40 CFR 703.5(g).

Maintenance and Withdrawal of Confidentiality Claims

EPA is requiring that, going forward, company contact information be kept up to date through CDX. When contacting a submitter concerning confidentiality claims, EPA will contact the submitter either through CDX directly or using the contact information provided by the submitter in CDX. When a confidentiality claim is being reviewed, a notice of the review and opportunity to substantiate or re-substantiate the confidentiality claim will be sent to the submitter using the information provided in CDX. Often, this will be done by sending the submitter an email from a CDX account notifying them that a document is available for download from CDX, which is why it is particularly important to have up-to-date information within the CDX platform. The details of this requirement are within 40 CFR 703.5(h).

EPA has also detailed the process for voluntarily withdrawing confidentiality claims submitted either in CDX or by other means. (40 CFR 703.5(i)). For CDX-submitted claims, the submitters must remove confidentiality markings, revise their documents, and resubmit these documents in CDX. For submissions not originally submitted through CDX, there is now a process for withdrawing the CBI claims through CDX using document-identifying details.

Confidential Status Change of TSCA Chemicals

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The confidential business information status of chemicals on the TSCA Inventory is scheduled for change, removing the confidential chemical identity status for 390 chemicals.  This will move the chemicals to the public portion of the TSCA Inventory.  During the 2012, 2016, and 2020 reporting periods, one or more manufacturers reported these chemicals as non-confidential, which is a result of at least one of these manufacturers not reporting a previous confidential chemical as confidential.

EPA recognizes that some manufacturers may have simply been in error for not reporting their chemicals as confidential.  However, EPA states that for each of the 390 chemicals, there is independent reporting based and EPA validated reasons to include the chemicals on the list.  EPA intends to move these chemicals from the confidential chemical identity status of the TSCA Inventory to the public portion sometime during the summer of 2021.

EPA also recognizes stakeholder interest in the status change for these chemicals and has given June 30, 2021 as a deadline for interest, questions, or concerns regarding the change.

EPA Releases Draft Guidance on TSCA CBI Disclosures and Requests Comments

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On March 13, 2018, EPA released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose TSCA confidential business information (CBI) with an expanded set of people. Comments will be accepted until April 16, 2018.

Amendments to the Toxic Substances Control Act (TSCA) expanded the categories of people who may now access information claimed as CBI under TSCA. Information that a business claims as CBI under TSCA is protected from disclosure until the business withdraws the CBI claim, until the CBI claim expires, until EPA determines that the claim is not entitled to confidential treatment, or as authorized under TSCA and EPA regulations.

The draft guidance documents are: