Keeping confidential business information (CBI) secret and protected from disclosure has long been a bedrock principle of the Toxic Substances Control Act (TSCA). TSCA Section 14 provides broad protection for proprietary information about chemicals in commerce and reflects a clear congressional intent to protect sensitive business information from disclosure, thereby fostering competition and rewarding innovation.
Chemical stakeholders have, over the decades, vigorously debated how best to balance the need for CBI protections with the public’s legitimate and increasing insistence that it has a right-to-know about chemicals to which people may be exposed. While Congress amended Section 14 in 2016, its core commitment to preventing disclosure of CBI remains undiminished.
Stakeholders in the environmental and public health community seeking greater transparency are challenging the U.S. Environmental Protection Agency’s (EPA) implementation of TSCA’s Section 5 new chemicals program. The case illustrates new challenges to balancing competing interests between protection and disclosure, and how anomalous judicial decisions can seemingly dictate the balance despite the absence of notice or engagement with the impacted CBI holder.
The case, Environmental Defense Fund v. Zeldin, No. 20-762 (D.D.C.), was filed in 2020 during the first Trump Administration. The claims the five non-governmental organizations (NGOs) assert are unsurprising as many environmental and public health NGOs have long expressed concern with EPA’s alleged lack of transparency in new chemical reviews and the public’s alleged limited ability to engage in the review process. Their claims relate to, among other new chemical regulatory provisions, the timeliness of EPA’s publication of receipt of notices and related information, EPA’s failure to provide online access to premanufacture notifications (PMN) and related documents, and whether EPA is unlawfully shielding from disclosure information ineligible for CBI protection including, for example, health and safety studies.
For readers unfamiliar with PMNs, they are voluminous submissions to EPA containing hundreds of pages of highly technical information and testing data on the new chemical, including its specific chemical identity and toxicological profile, how the chemical will be made, its uses and applications, how it might be released into the environment, and related information. PMNs are essentially the blueprint for a new chemical innovation and brimming with CBI that typically reflects years of commercial investment and proprietary ingenuity. When submitting a PMN, submitters provide two versions — a CBI-version and a redacted non-CBI version.
Prior to filing the case, Plaintiffs requested hundreds of PMN public files from EPA. EPA’s response included non-CBI portions of the notices. Plaintiffs claim the public files they received from EPA were incomplete in that they were either missing documents entirely or contained documents that were overly redacted. The parties engaged for years in protracted discussions about the administrative record for judicial review and whether the record should include fully unredacted copies of PMNs.
These discussions culminated in a highly unusual December 2025 Order directing EPA to produce 84 entirely unredacted PMNs under the terms of a Protective Order the parties — to the exclusion of the individual CBI holders — negotiated. Not being a litigant in the case, it is unclear what exactly these discussions entailed and why they took so long. What is clear is that the outcome is unusual for at least three reasons. First, even with a Protective Order, disclosing information in the PMNs that is indisputably CBI is unusual and seems excessive by any standard, and seemingly much broader than necessary to address the particular claims raised by Plaintiffs. Second, the terms of the Protective Order are less protective than the measures EPA has long employed to protect CBI. Third, the submitters of the PMNs at issue in the case were most likely unaware that their PMNs are the subject of litigation, and, until recently, not engaged.
Under TSCA Section 14(d)(9), before EPA can disclose confidential information pursuant to a court order, EPA must provide notice pursuant to TSCA Section 14(g)(2) to the confidential information holder, in this case, the PMN submitters. EPA’s notice makes clear that the information will remain confidential and that recipients are subject to the terms of a Protective Order, but absent the filing of an action in federal district court to restrain the release of the CBI within 30 days of receipt, the submitter’s CBI will be disclosed.
This is deeply unsettling news to any new chemical innovator and reveals a new wrinkle in the ongoing debate over how to manage CBI. There are many interesting legal issues to unpack in this case and doing so is well beyond the scope of this blog. Key questions include: Why are fully unredacted PMNs being made available to the Plaintiffs for review, especially where, as here, information that is presumptively CBI seems unrelated to the Plaintiffs’ claims? In litigation where CBI may be forcibly disclosed, should EPA really be the sole negotiator for the PMN submitters? Should the CBI holders have been engaged by EPA earlier? What recourse does a CBI holder have under these circumstances if its proprietary information is inadvertently disclosed? In this case, the Protective Order offers no commercially satisfactory remedy for inadvertent disclosure, and other terms in the Protective Order fall well short of the level of protection EPA itself affords CBI holders under TSCA.
The court will need to address these and other issues as PMN submitters can be expected to assert their right to restrain disclosure under TSCA Section 14. These issues may well be prologue to a whole new constellation of CBI-related issues raised by a fast-approaching deadline under the 2016 amendments to TSCA. Among many other revisions, the amendments included a ten-year cap on many CBI claims. As a result, certain CBI claims will begin to expire on a rolling basis in June 2026 unless they are reaffirmed and re-substantiated. TSCA requires EPA to provide companies with notice at least 60 days prior to expiration.
EPA has indicated that it expects to provide notice through multiple forums, including communications through EPA’s Central Data Exchange (CDX) portal and regular publication of a list of submissions with near-term expiring CBI claims on EPA’s CBI program website. Secure messages from EPA in CDX are also followed by a notification email to the authorized official’s registered email account. Even with all these measures, CBI claimants will need to be hypervigilant or risk losing their claims to confidentiality.
Changes in TSCA and judicial challenges such as the case discussed above are making it more challenging to assert and maintain CBI. Similar issues are being litigated in Inhance Technologies LLC v. Zeldin, No. 25-980 (D.D.C.), a more recent case involving research and development data, customer data, and related sensitive business information. TSCA stakeholders will want to monitor these cases and other developments related to CBI. TSCA stakeholders claiming confidentiality will need to assert claims smartly and manage them carefully and more proactively to protect their CBI and avoid the significant competitive harms that may result from disclosure.
*The views expressed in this blog are my own.
