2026 is shaping up to be a big year for the Toxic Substances Control Act (TSCA): the current administration may finalize amendments to a foundational TSCA rule governing how risk evaluations are conducted; Congress must reauthorize TSCA’s fee schedule in the summer of 2026; and industry is urging Congress to enact a broad range of changes to the statute.
But perhaps flying under the radar is that 2026 is the 10-year anniversary of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (the “Lautenberg Amendments”). More than just a symbolic anniversary, this year has real implications for businesses who claim the identity of a chemical substance as confidential business information (CBI) under TSCA.
According to TSCA section 14(e), chemical identities claimed as CBI are protected from disclosure by EPA “for a period of 10 years from the date on which the person asserts the claim with respect to the information submitted to the Administrator.” 15 U.S.C. 2613(e)(1)(B)(i). This means that if an organization claimed the identity of a chemical substance as CBI in 2016, shortly after the Lautenberg Amendments, the claim needs to be reasserted (i.e. the submitting party claims the information as CBI) and substantiated (i.e. the process by which a party justifies its CBI claim) in the coming months to avoid the chemical identity becoming public, by default, on the TSCA inventory.
TSCA requires EPA to provide only 60-days’ notice of expiring CBI claims, 15 U.S.C. 2613(e)(2)(A); Frequently Asked Questions about TSCA CBI. Sometime early this spring, EPA intends to post on EPA’s CBI website the first list of TSCA submissions with expiring CBI claims. This is in addition to the direct notices EPA will send to submitters with expiring claims through EPA’s Central Data Exchange (CDX), which presumably will be sent at least 60-days before the CBI’s expiration to comply with 15 U.S.C. 2613(e)(2)(A). EPA requires all reassertions of CBI be submitted 30 days prior to the expiration date of CBI claims. EPA is under no obligation to protect CBI if it does not receive a reassertion and CBI may be made public without any further notice to the submitter.
Nonetheless, some information claimed as CBI, such as marketing and sales information or information identifying a supplier or customer, will remain protected against disclosure notwithstanding TSCA’s sunsetting protections for claims initially raised in 2016. 15 U.S.C. 2613(c)(2) (entitled “Information Generally Not Subject To Substantiation Requirements”). The types of information described in 15 U.S.C. 2613(c)(2) do not require reassertion or substantiation and EPA is required to protect such information from disclosure until either the party asserting the CBI claim withdraws the claim or EPA “becomes aware that the information does not qualify for protection from disclosure under this section.” 15 U.S.C. 2613(e)(1)(A). Thus, companies need not reassert a CBI claim on the types of information listed in 15 U.S.C. 2613(c)(2), and there is no time limit to associated CBI claims.
But it at least a little unclear what would make EPA aware that “the information does not qualify for protection from disclosure.” As EPA may now be able to, with limited notice and through no act but time, disclose certain chemical identities without explicit consent from the submitting party or reasoned decision from EPA, see 15 U.S.C. 2613(e)(1)(B)(i), where a party does not reassert and substantiate the CBI claim, could that action make EPA aware the information does not qualify as CBI anymore? While it remains likely that the CBI described in 15 U.S.C. 2613(c)(2) would remain confidential unless otherwise required to be disclosed by TSCA or other law, it is worth monitoring how EPA chooses to handle the information identified in 15 U.S.C. 2613(c)(2) for any chemical identity CBI claims that are allowed to expire.
Further complicating compliance, CBI that is not subject to the protections described above is now subject to new and updated regulations governing CBI assertions and substantiations. See 88 F.R. 37155. Codified at 40 C.F.R. § 703, those regulations “describe procedures for asserting and maintaining confidentiality claims in accordance with TSCA section 14, and for EPA review of such claims.” 40 C.F.R. § 703.1(a). To streamline the administrative process, applicants must now answer specific questions to substantiate their CBI claims. 40 C.F.R. § 703.5(b). And the regulations now require that nearly all CBI claims be submitted electronically through CDX, a process quite different from that ten years ago. 40 C.F.R. § 703.5(f). Any party seeking to reassert a confidentiality claim for the first time since 2016 should carefully review the regulations to ensure compliance with new requirements. Reassertions of CBI claims are due no later than 30 days prior to the expiration of prior CBI claims.
Organizations that choose not to reassert a CBI claim are still subject to regulatory obligations. For example, any person whose confidentiality claim expired must “prepare and submit a revised public copy of the submission to EPA.” 40 C.F.R. § 703.5(j)(1). Letting a CBI claim expire is not as simple as doing nothing; the regulations require action from any party whose CBI claim is expiring.
Expiring CBI claims affect more than just the party who originally asserted the claim. Downstream users of chemicals may have an interest in the protection of the CBI-claimed information. Those downstream users should, if it is determined to be potentially in their interests, review the status of all chemicals used in their manufacturing processes and prepare to have discussions with suppliers about CBI reassertion and substantiation.
Strong organizational recordkeeping can preempt many TSCA issues. maintaining organization-specific records of TSCA-claimed CBI and setting appropriate internal alerts for review of those records can ensure your organization is not scrambling in the 11th hour to reassert and substantiate decade-old CBI claims. If your organization is seeking to compile relevant CBI expiration deadlines, those are available on the TSCA inventory.
This article was authored by partner Wade Stephens, who can be reached at wstephens@lssh-law.com.