Under the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA), most confidential business information (CBI) claims will expire after ten years unless reasserted and substantiated. This means that a CBI claim made in 2016 will expire in 2026 unless the claim is reasserted and resubstantiated before the end of the ten-year period. The U.S. Environmental Protection Agency (EPA) issued in June 2023 a final rule with new and amended requirements concerning the assertion and treatment of CBI claims for information reported to or otherwise obtained by EPA under TSCA. According to the final rule, “EPA will publish on its website, or other appropriate platform, a list of TSCA submissions with confidentiality claims that are approaching the end of the ten-year period of protection described in” TSCA Section 14(e). EPA states that it will add TSCA submissions to this list “at least 60 days prior to the end of the ten-year period of protection, along with instructions for reasserting and substantiating expiring claims.” EPA’s website includes a page entitled “Frequent Questions about TSCA CBI” that was last updated on August 11, 2025. The page includes the following question and answer:

Q3. TSCA section 14(e) provides for potential limitations on the duration of CBI claims. How does EPA expect to implement this provision?

Information submitters should be aware that TSCA section 14(e) limits the duration of many confidentiality claims to 10 years, unless those claims are timely reasserted and substantiated. TSCA section 14(e) requires EPA to notify the submitter of a CBI claim at least 60 days prior to the expiration of a claim. Additionally, if EPA denies the claim, TSCA section 14(g)(2) requires that EPA notify the submitter at least 30 days prior to the intended disclosure of the information. EPA has elaborated on the notice, reporting, and EPA review requirements in the CBI procedural rule at 40 CFR 703 and expects to develop an electronic reporting tool to further implement this provision.

More information on EPA’s June 2023 CBI rule is available in our June 12, 2023, memorandum.

Commentary

The beginning of the sunset process will be a challenge and learning experience for submitters and EPA. Submitters should begin now to ensure that their older submissions have up-to-date technical contact(s) and consider adding one or more agents to ensure that EPA will be able to communicate confidently with the contact. Submitters should also monitor the list that EPA posts and watch for updates. 

Submitters may also wish to consider whether it is necessary to maintain all the CBI claims previously asserted. It may be that with the passage of time, the information has since become public (and therefore is not amenable to protection) or is no longer sensitive.