Notice2026-00002

Expiration and Extension of Confidential Business Information (CBI) Claims Under the Toxic Substances Control Act (TSCA)

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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
January 6, 2026

Issuing agencies

Environmental Protection Agency

Abstract

On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act (TSCA), was signed into law. Under TSCA, non-exempt confidential business information (CBI) claims expire no later than 10 years after their submission. The first of these expire in June 2026. EPA is providing notice of its intended process for implementing the statutory requirements associated with expiring CBI claims, including confirming how the Agency will notify companies of expiring claims and how companies may request and substantiate the need for an extension of their CBI claims.

Full Text

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<title>Federal Register, Volume 91 Issue 3 (Tuesday, January 6, 2026)</title>
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[Federal Register Volume 91, Number 3 (Tuesday, January 6, 2026)]
[Notices]
[Pages 371-373]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-00002]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2025-3753; FRL-13134-01-OCSPP]


Expiration and Extension of Confidential Business Information 
(CBI) Claims Under the Toxic Substances Control Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On June 22, 2016, the Frank R. Lautenberg Chemical Safety for 
the 21st Century Act, which amended the Toxic Substances Control Act 
(TSCA), was signed into law. Under TSCA, non-exempt confidential 
business information (CBI) claims expire no later than 10 years after 
their submission. The first of these expire in June 2026. EPA is 
providing notice of its intended process for implementing the statutory 
requirements associated with expiring CBI claims, including confirming 
how the Agency will notify companies of expiring claims and how 
companies may request and substantiate the need for an extension of 
their CBI claims.

[[Page 372]]


ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2025-3753, is available at 
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets 
generally, along with instructions for visiting the docket in-person, 
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.

FOR FURTHER INFORMATION CONTACT: 
    For technical information: Jessica Barkas, Chemical Information, 
Prioritization, and TRI Division, Office of Pollution Prevention and 
Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW, Washington, DC 20460-0001; telephone number: (202) 250-8880; email 
address: <a href="/cdn-cgi/l/email-protection#2f4d4e5d444e5c01454a5c5c464c4e6f4a5f4e01484059"><span class="__cf_email__" data-cfemail="593b382b32382a77333c2a2a303a38193c2938773e362f">[email&#160;protected]</span></a>.
    For general information on TSCA: The TSCA Assistance Information 
Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave., 
Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-
1404; email address: <a href="/cdn-cgi/l/email-protection#84d0d7c7c5a9ccebf0e8edeae1c4e1f4e5aae3ebf2"><span class="__cf_email__" data-cfemail="12464151533f5a7d667e7b7c77527762733c757d64">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This announcement is directed to the public in general. It may be 
of particular interest to entities that have submitted CBI to EPA under 
TSCA beginning in June 2016. Because this action is directed to the 
general public and other entities may also be interested, the Agency 
has not attempted to describe all the specific entities that may be 
interested in this action. If you have any questions regarding the 
applicability of this action to a particular entity, please consult the 
contact listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    TSCA section 14(e)(1)(B) provides that information determined by 
EPA to be CBI shall be protected from disclosure ``[. . .] for a period 
of 10 years from the date on which the person asserts the claim [. . 
.].'' This period may be extended in accordance with TSCA section 
14(e)(2)(B)(i) if ``Not later than the date that is 30 days before the 
expiration of the period described in paragraph (1)(B)(i), a person 
reasserting the relevant claim [submits] to the Administrator a request 
for extension substantiating, in accordance with subsection (c)(3), the 
need to extend the period.''

C. What action is the Agency taking?

    EPA is explaining how it intends to implement the requirements of 
TSCA section 14(e)(2), concerning the expiration and potential 
extension of the protection period for TSCA CBI claims. EPA previously 
published rules at 40 CFR 703 describing the Agency's procedures for 
notices concerning CBI claims as well as procedures and standards for 
Agency review of new and renewed requests for CBI protection.
    This document provides further information on the form and manner 
in which EPA expects to provide notice of claim expiration and 
reporting instructions for entities seeking to request an extension of 
the initial 10-year period of CBI protection under TSCA section 
14(e)(2)(B)(ii). EPA expects to refine these instructions and 
procedures as the Agency gains experience implementing TSCA section 
14(e).
    In accordance with TSCA section 14(e)(2)(A), EPA shall ``[. . .] 
provide to the person that asserted the claim a notice of the impending 
expiration of the period'' not later than 60 days prior to the date the 
claim is to expire. Per 40 CFR 703.5(h)(2) and (3), this notice will be 
made on EPA's website (or other appropriate platform) in the form of a 
public list of TSCA submissions with expiring CBI claims. 
Alternatively, or in addition, the Agency may transmit a direct notice 
to the submitter via the Central Data Exchange (CDX) available at 
<a href="https://cdx.epa.gov/">https://cdx.epa.gov/</a>, EPA's centralized electronic document system.
    Expiration dates for CBI claims for information other than specific 
chemical identities are set 10 years from the date the information was 
submitted to EPA. CBI claims exempt from substantiation requirements 
and CBI review under TSCA section 14(c)(2) are also exempt from 
expiration under TSCA section 14(e)(1)(B).
    Expiration dates for claims for the specific chemical identity of a 
substance are set 10 years from the first approved confidentiality 
claim for the specific chemical identity of that substance. Any 
subsequent TSCA submissions on that substance claiming the specific 
chemical identity as confidential do not reset that expiration date, 
meaning that in some instances submitters may be notified of an 
expiring CBI claim for specific chemical identity less than 10 years 
from the date of their later submissions. Expiration dates for chemical 
identities are available on the TSCA Chemical Substance Inventory 
available at <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
    To extend an expiring CBI claim, an entity must submit a request 
for extension substantiating the need to extend the CBI protection. The 
extension period may last up to an additional 10 years. Substantiation 
requirements are provided in 40 CFR 703.5(a) and (b). Rules identifying 
information not subject either routine substantiation requirements or 
to 10-year expiration under TSCA section 14(e) can be found in 40 CFR 
703.5(b)(5). Per TSCA section 14(e)(2)(B)(ii), EPA will review each 
request for extension and either grant or deny the request.
    Submitters must electronically submit their substantiated request 
for extension, using the appropriate reporting tool in CDX. EPA is 
currently developing this tool. More specific instructions for 
submitting requests for extension will be made available prior to 
publication of the initial notices of CBI claim expiration. EPA expects 
to have the CDX tool in place prior to the time claims begin to expire. 
If there is a delay, EPA will provide notice of this delay and provide 
an estimated date of completion on the EPA's TSCA CBI website available 
at <a href="https://www.epa.gov/tsca-cbi">https://www.epa.gov/tsca-cbi</a>. Should a delay occur, submitters 
should postpone sending extension requests until EPA has provided 
notice that the CDX tool is available. Under 15 U.S.C. 2613(g)(1)(D), 
EPA will not release any information subject to expiring claims until 
the notice and review requirements of section 14(e) are met.
    If EPA does not receive a timely request for extension via the CDX 
reporting tool, the Agency would no longer be required to safeguard the 
previously protected information from disclosure, and the information 
may be made public without further notice to the submitter. See 15 
U.S.C. 2613(g)(2)(C)(iii)(II) (notice of disclosure not required where 
a CBI claim has expired and no person submitted a timely extension 
request following timely notice of expiration).

D. Considerations for Entities Prior to the Claim Expiration Date

    EPA anticipates providing individual notices via CDX communications 
consistent with 40 CFR 703.5(h)(2) and publishing lists of TSCA 
submissions and information for which claims will be expiring, 
consistent with 40 CFR 703.5(h)(3). To receive notice via CDX, 
submitters must maintain or update their contact information, as 
described in 40 CFR 703.5(h)(1).
    EPA recommends that entities that submitted TSCA information in 
June 2016 or later should consider several issues well in advance of 
the end of the 10-year period of CBI claim protection. For example, CBI 
claim submitters should assess whether confidentiality remains 
necessary for expiring claims and identify the person(s) designated as

[[Page 373]]

the technical contact(s) for any TSCA submissions asserting an expiring 
CBI claim.
    In addition to updating company contact information as discussed in 
this Unit (see 40 CFR 703.5(h)(1)), companies or company contacts with 
lapsed or inaccessible CDX accounts should reestablish that access by 
contacting and working with the CDX helpdesk available at 
<a href="/cdn-cgi/l/email-protection#5139343d213534223a113421303235297f3f3425"><span class="__cf_email__" data-cfemail="aac2cfc6dacecfd9c1eacfdacbc9ced284c4cfde">[email&#160;protected]</span></a> as early as possible. In general, submitters should 
take care to preserve their CDX passphrases to expedite access to their 
TSCA submissions.
    Companies should also consider whether they submitted information 
claimed as CBI outside of CDX (e.g., paper TSCA filings pre-dating 
electronic filing requirements for that submission type, or physical 
material provided to EPA pursuant to a TSCA subpoena or inspection). 
Such entities should regularly consult EPA's online notice of CBI 
filings with expiring claims and submissions with expiring claims to 
determine if they have submissions eligible for CBI protection 
extension.
    EPA plans to communicate with stakeholders prior to and after the 
CBI claim extension process begins. EPA anticipates the CBI claim 
extension process will begin in spring 2026. EPA expects to provide 
further guidance, to solicit and answer questions, and potentially to 
host a webinar with information on notices of expiration and 
instructions for requesting extensions. Entities should monitor the 
Federal Register and EPA websites, listservs, and other communications 
for further information about expiring TSCA CBI claims and when and how 
to request CBI protection extensions.

(Authority: 15 U.S.C. 2613.)

     Dated: December 30, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2026-00002 Filed 1-5-26; 8:45 am]
BILLING CODE 6560-50-P


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Indexed from Federal Register on January 6, 2026.

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