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