Beware: 10-Year Expiration of TSCA Confidential Business Information (CBI) Claims is Upon Us

The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to the Toxic Substances Control Act (TSCA) in 2016 included several new provisions intended to balance companies’ legitimate needs to protect confidential business information (CBI) with increasing public transparency of chemical information. In 2016, companies were required to substantiate certain CBI claims at the time of submission in an effort to reduce unwarranted CBI claims. Beginning soon, however, is another key feature of the Lautenberg amendments: the expiration of certain CBI claims after 10 years. This column explains the requirements related to CBI expiration, what companies need to know, how to extend CBI protections and how best to prepare for this new and significant component of TSCA compliance.

What CBI claims will expire?

CBI claims that were subject to the TSCA CBI substantiation requirements in the 2016 Lautenberg amendments will expire 10 years after the claim was made (not when the U.S. Environmental Protection Agency (EPA) reviewed the claim, if it did), absent an approved request for extension. That means that CBI claims for important elements like chemical identity, chemical structure and formula for substances that have been commercialized, company name, information in study reports that is not health and safety information (e.g., the study sponsor and lab) and more will all begin to expire as early as June 22, 2026, and will continue to expire on a rolling basis thereafter. CBI claims that are exempt from substantiation do not expire and remain protected unless and until a company withdraws or EPA determines that the information is no longer entitled to protection. These claims include, for example, information on marketing and sales, production volume, process descriptions and diagrams, customers/suppliers and specific uses and applications of the chemical.

How will expiration information be communicated?

TSCA requires that EPA provide companies notice at least 60 days prior to expiration. EPA expects to provide notice through multiple forums, including communication via the EPA’s Central Data Exchange (CDX) portal and the regular publication of a list of submissions with near-term expiring CBI claims on EPA’s CBI program website. Expiration dates for chemical identities can also be found on the TSCA Inventory. Secure messages from EPA in CDX are also followed by a notification email to the authorized official’s registered e-mail account. EPA recommends adding “[email protected]” to the list of trusted senders to ensure receipt of these notifications.

What happens if a CBI claim expires?

Information subject to expired CBI claims will no longer be protected from public release. EPA may therefore disclose such information without any further notice to the company.

How can CBI information be protected?

Companies that wish to extend CBI protection beyond 10 years must submit an extension request to EPA at least 30 days prior to the claim’s expiration date and resubstantiate any claims the company seeks to maintain. To facilitate extension requests, EPA is developing a new reporting application within CDX that is expected to be available soon. EPA must make a determination on each request for extension/renewal of the CBI claim within 30 days of the request.
What should I do now to prepare?

CBI owners may wish to take stock of all types of a company’s TSCA submissions in CDX, including, for example, premanufacture notifications (PMN), low volume exemptions (LVE), notices of commencement (NOC), chemical data reporting (CDR) reports, support documents, documents generated in enforcement contexts, and TSCA communications, and determine which ones have CBI claims nearing expiration. If possible, update technical contacts and agents in CDX to ensure EPA communications are appropriately directed, but note that EPA asks specifically that submitters not change substantiation in existing submissions. Make a list of cases with claims that will expire in the next six to 12 months to enable monitoring of EPA’s CBI program website for forthcoming news on the CDX reporting tool and publication of expiration lists. 

CBI expiration begins in June 2026 (with EPA notices expected to arrive in April), but will continue to occur in perpetuity as various submission dates reach the 10-year milestone. Note that the 2016 CDR reporting will be a large tranche of submissions, as will the Notice of Activity submissions (colloquially called the “Inventory Reset”), made in 2017-2018.

This 10-year expiration paradigm will challenge EPA and submitters. Companies need to be prepared to respond promptly to maintain substantiated CBI claims. Further information is available on EPA’s website.