Overview
The US Environmental Protection Agency (EPA) is preparing for a large number of confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA) to begin expiring in June 2026. See 91 Fed. Reg. 371 (Jan. 6, 2026). This marks 10 years since the 2016 Lautenberg amendments, which set a 10-year limit on most CBI claims unless affirmatively renewed. EPA anticipates a rolling "CBI sunset" process affecting several thousand submissions through the end of 2027.
Companies must reassert and substantiate CBI claims before the 10-year deadline to maintain protection. Those failing to submit timely or complete requests risk public disclosure of previously confidential information. Certification and substantiation requirements are outlined in 40 C.F.R. § 703.5(a) and (b). Rules identifying information not subject to either routine substantiation requirements or the 10-year expiration under TSCA section 14(e) can be found in 40 C.F.R. § 703.5(b)(5).
EPA Preparation and CDX Portal
EPA is developing new processes and IT tools within its Central Data Exchange (CDX) system to handle the expected surge in requests. Public lists of expiring CBI claims will be posted on the TSCA CBI website, and companies will receive at least 60 days' notice via CDX. Requests must be submitted at least 30 days before expiration, and EPA will determine whether to grant extensions of up to 10 years. Agency officials have indicated they are "scrambling" to prepare the portal, while providing certain flexibilities to prevent inadvertent disclosures.
Industry Concerns
Industry stakeholders have raised concerns about EPA's CBI re-substantiation process, citing uncertainties regarding notification procedures, tracking of claims, personnel changes, and the overall administrative burden. Stakeholders suggest that EPA confirm that companies which have asserted CBI claims (1) have current contact information on file; (2) consider aggregating CBI claims by chemical substance rather than individual submissions, and (3) provide sufficient time for companies to assess and substantiate their claims.
Litigation and Disclosure Risks
Legal challenges are also increasing scrutiny. If EPA determines that a CBI claim should be denied and intends to disclose the information, it must provide the submitter with at least 30 days' advance notice. This notice affords the submitter a final opportunity to defend the confidentiality claim or submit additional substantiation before the information is made public. If this process does not resolve the issue, the claimant may pursue other remedies, including filing a complaint in federal court to prevent disclosure.
Of note, in Environmental Defense Fund v. Zeldin, No. 1:20‑cv‑00762‑LLA (D.D.C. filed Mar. 18, 2020), the court ordered EPA to produce approximately 84 full, unredacted premanufacture notices (PMNs) as part of the administrative record, under a protective order, by March 23, 2026. These include PMNs containing CBI claimed, certified, and, where applicable, substantiated by the submitters. EPA did not produce the unredacted PMNs by the March 23, 2026 deadline and instead sought a stay of the production order in light of a TSCA § 14 challenge brought by one of the affected PMN submitters.
In Arkema Inc. v. EPA, No. 1:26‑cv‑00886‑LLA (D.D.C. filed Mar. 13, 2026), Arkema—one of the PMN submitters whose CBI is subject to the disclosure order—has sued EPA under TSCA § 14 and the Administrative Procedure Act to prevent disclosure of the CBI in its PMNs, arguing that the compelled disclosure is overbroad, insufficiently protective under the terms of the protective order, and not authorized by TSCA § 14(d)(9). Both matters are pending before the same judge in the US District Court for the District of Columbia.
Key Takeaways for Companies
- Review and Inventory: Audit TSCA submissions on or after June 22, 2016, and assess whether confidentiality is still warranted.
- Update Contact Information: Ensure CDX accounts and responsible company contacts are current.
- Prepare Early: Develop substantiation documentation and internal processes for handling re-substantiation requests.
- Monitor Litigation: Follow cases like EDF v. Zeldin and Arkema Inc. v. EPA, which may influence EPA guidance and disclosure requirements.
- Consider Process Improvements: Consolidate claims for substances with multiple submissions to reduce administrative burden.
Failure to act could result in unintentional public disclosure, especially for companies with multiple or high-value CBI claims.
Assistance and Guidance
Companies seeking guidance on TSCA CBI substantiation, navigating the CDX portal, or understanding litigation implications should consult Michael Boucher and Nina MacLeay at Steptoe to mitigate disclosure risks.
