Overview
The US Environmental Protection Agency (EPA) is preparing for a large number of confidential business information (CBI) claims submitted under the Toxic Substances Control Act (TSCA) to begin expiring in June 2026. This date marks ten years since the 2016 Lautenberg amendments, which imposed a 10-year limit on most TSCA confidentiality claims unless they are affirmatively renewed. As a result, EPA anticipates a continuous, rolling "CBI sunset" process that could affect several thousand submissions between mid-2026 and the end of 2027. See 91 Fed. Reg. 371 (Jan. 6, 2026).
Under the amended law, companies must reassert and resubstantiate their CBI claims before the 10-year deadline to maintain protection. Congress designed this requirement to ensure that only information that still genuinely warrants confidential treatment remains protected, and to prevent outdated or unnecessary secrecy. A likely outcome of this review process is that more chemical information previously protected as confidential will eventually become publicly available if claims are not renewed or cannot be justified.
EPA is developing new processes and information technology tools within its Central Data Exchange (CDX) system to manage the anticipated surge in resubstantiation requests. The agency plans to post public lists of TSCA submissions with expiring CBI claims on its TSCA CBI website and to provide at least 60 days' notice to affected companies, primarily through CDX notifications and related communications. EPA has acknowledged the operational challenges of compiling expiring claims, issuing notices, and reviewing extension requests, particularly in light of staffing losses and recent government shutdowns.
Nevertheless, to extend a CBI claim, companies must submit a substantiated extension request electronically through CDX no later than 30 days before the claim's expiration. These requests must include updated certifications and detailed justification demonstrating the continued need for confidentiality, consistent with TSCA and EPA's regulations. EPA will review each request and either grant or deny the extension, which may last for up to an additional 10 years. If a company fails to submit a timely and complete extension request, EPA is no longer required to protect the information from disclosure. In such cases, the previously confidential information may be made public without further notice to the submitter. Substantiation requirements are provided 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).
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.
EPA is advising companies to begin preparing well in advance by reviewing TSCA submissions made on or after June 22, 2016, inventorying existing CBI claims, and assessing whether confidentiality is still necessary. Regulated entities should also ensure that their CDX accounts and contact information are current so they receive all required notices. Early preparation, familiarity with EPA guidance, and internal planning will be critical to managing the demands of the TSCA CBI sunset program and avoiding unintended public disclosure. The consequences of inaction are therefore significant, particularly for companies with multiple or high-value CBI claims.
Should your company require advice and guidance with the review of regulations governing the substantiation of TSCA CBI, experienced professionals are available to help.
