Notice2024-01351
Toxic Substances Control Act Review of CBI Claims for the Identity of Chemicals in the TSCA Inventory; Extension of Review Period
Primary source
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 24, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This document announces the extension of the review period for Confidential Business Information (CBI) claims for specific identify of all active chemical substances listed on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory submitted to the EPA under TSCA. EPA has determined that an extension of the statutory review period for the review of CBI claims under TSCA are necessary to allow the Agency to complete the required reviews under TSCA.
Full Text
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<title>Federal Register, Volume 89 Issue 16 (Wednesday, January 24, 2024)</title>
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[Federal Register Volume 89, Number 16 (Wednesday, January 24, 2024)]
[Notices]
[Pages 4605-4606]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-01351]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0320; FRL-11655-01-OCSPP]
Toxic Substances Control Act Review of CBI Claims for the
Identity of Chemicals in the TSCA Inventory; Extension of Review Period
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This document announces the extension of the review period for
Confidential Business Information (CBI) claims for specific identify of
all active chemical substances listed on the confidential portion of
the Toxic Substances Control Act (TSCA) Inventory submitted to the EPA
under TSCA. EPA has determined that an extension of the statutory
review period for the review of CBI claims under TSCA are necessary to
allow the Agency to complete the required reviews under TSCA.
DATES: The review period is extended to February 19, 2025.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0320, is available online
at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Additional instructions for visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Jessica Barkas, Project
Management and Operations Division (7401), Office of Pollution
Prevention and Toxics, 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#84e6e5f6efe5f7aaeee1f7f7ede7e5c4e1f4e5aae3ebf2"><span class="__cf_email__" data-cfemail="e68487948d8795c88c8395958f8587a6839687c8818990">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#1e4a4d5d5f3356716a7277707b5e7b6e7f30797168"><span class="__cf_email__" data-cfemail="13474050523e5b7c677f7a7d76537663723d747c65">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
You may be affected by this action if you submitted a Notice of
Activity Form A to EPA under TSCA section 8(b)(4) and 40 CFR part 710,
subpart B and asserted any CBI claims concerning the specific
identities of the chemical substances you reported. Persons who seek
information on such submissions may also be affected by this action.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Manufacturers, importers, or processors of chemical
substances (NAICS codes 325 and 324110), e.g., chemical manufacturing
and petroleum refineries.
If you have any questions regarding the applicability of this
action to a particular entity, consult the technical contact person
listed under FOR FURTHER INFORMATION CONTACT.
II. What is the Agency's authority for taking this action?
TSCA authorizes the extension of the Review Plan deadline in TSCA
section 8(b)(4)(E)(ii)(I), 15 U.S.C. 2607(b)(4)(E)(ii)(I).
III. What action is the Agency taking?
EPA is announcing to the public that it is extending an Agency
review deadline pursuant to the authority in TSCA section
8(b)(4)(E)(ii)(I), 15 U.S.C. 2607(b)(4)(E)(ii)(I). The additional time
is necessary to complete the reviews given the volume of submissions
that require review, information technology issues, and other legal and
administrative delays that have affected the review process. EPA will
evaluate progress toward completing the requirements for the Agency to
review CBI substantiations outlined in the final rule entitled
``Procedures for Review of CBI Claims for the Identity of Chemicals in
the TSCA Inventory'' (Review Plan rule), (85 FR 13062, March 6, 2020
(FRL-10005-48)), which set a deadline of February 19, 2024. This action
will extend the deadline by a year and as this extended deadline
approaches the Agency may further extend the deadline as necessary to
complete the Review Plan reviews.
IV. What is the TSCA Review Plan?
Pursuant to TSCA section 8(b), EPA finalized the Review Plan rule
establishing, inter alia, the Agency's plan for reviewing all active
TSCA Inventory CBI claims concerning specific chemical identity that
had been made in Active-Inactive rule reporting taking place in 2017
and 2018 (see 40 CFR part 710, subparts B (Commercial Activity
Notification) and C (Review Plan)). Consistent with TSCA section
8(b)(4)(E)(i), which allows a five-year period for these reviews
following compilation of an initial list of active substances, the
reviews were targeted for completion by February 19, 2024 (see 40 CFR
710.55(d). Since finalizing
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the Review Plan rule, however, EPA has encountered issues that,
cumulatively, make reaching this target highly unlikely. Consequently,
consistent with TSCA section 8(b)(4)(E)(ii)(I) and 40 CFR 710.55(e)
which permit EPA to extend the review period by up to two years, EPA is
extending the target review completion date until February 19, 2025. As
this extended deadline approaches, EPA will re-evaluate the Review Plan
progress and will further extend the deadline, as necessary to complete
the Review Plan reviews, up to February 19, 2026.
Several issues and factors caused delays that are expected to
prevent EPA from completing its review within the five-year period.
Firstly, the volume of claims is significant. EPA received and is
reviewing CBI claims for the specific chemical identity of more than
4,805 chemical substances in 5,787 submissions under the Review Plan.
At the same time, the Agency is maintaining its CBI review program for
new CBI claims under TSCA section 14(g). This involves reviewing
numerous and varied types of TSCA submissions, containing a wide array
of CBI claims of differing complexity. The Agency receives
approximately 600 submissions with multiple CBI claims requiring review
under TSCA section 14(g) each year. Also concurrent with these CBI
review activities, EPA is processing denied and withdrawn CBI claims
for chemical identity so that those chemical identities may be
disclosed on the public portion of the TSCA Inventory, consistent with
the requirements of TSCA sections 8(b) and 14.
Secondly, adapting the Agency's information technology (IT) systems
to complete these reviews has presented issues and contributed to
delays as part of processing the voluminous amount of CBI claims. For
example, in its reviews, EPA observed duplication of and
inconsistencies between confidentiality claims for the same chemicals
across and between submissions. Limitations with existing IT tools have
made identifying and resolving such issues a largely manual process,
which consumes resources and delays Agency reviews. In addition, the
size (i.e., very large file size) and other features of certain
submissions have caused IT difficulties that have halted the CBI review
process for more than six months and these issues have not yet been
resolved as available resources have been prioritized to address more
critical IT needs.
Finally, EPA could not start its Review Plan reviews until after a
delay of approximately six months to a year as a result of the decision
of the U.S. Court of Appeals for the District of Columbia Circuit in
Environmental Defense Fund v. EPA, 922 F.3d 446 (D.C. Cir. 2019). The
Court's decision meant that any company who had voluntarily provided
substantiation in their initial Notice of Activity filing (mostly made
in 2018) had to ensure those prior submissions included information
regarding reverse engineering (generally by answering two additional
substantiation questions), and that EPA had to provide a reporting
period for doing so prior to beginning any Review Plan reviews. EPA
published a supplement to the proposed Review Plan rule to address the
Court's decision on November 8, 2019 (84 FR 60363 (FRL-10001-44)). The
final rule required substantiation or supplemental substantiation by
November 2020 (see 40 CFR 710.47). The additional reporting requirement
created confusion among some reporting entities, the resolution of
which has further slowed the review process.
These issues and factors together justify extending the review
period deadline by at least one year, consistent with TSCA section
8(b)(4)(E)(ii)(I).
Authority: 15 U.S.C. 2607(b).
Dated: January 18, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-01351 Filed 1-23-24; 8:45 am]
BILLING CODE 6560-50-P
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