[Federal Register Volume 89, Number 16 (Wednesday, January 24, 2024)]
[Notices]
[Pages 4605-4606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 http://www.regulations.gov. Additional instructions for visiting the 
docket, along with more information about dockets generally, is 
available at https://www.epa.gov/dockets.

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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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:
     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

[[Page 4606]]

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]
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