Toxic Substances Control Act Review of CBI Claims for the Identity of Chemicals in the TSCA Inventory; Extension of Review Period, 4605-4606 [2024-01351]
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Federal Register / Vol. 89, No. 16 / Wednesday, January 24, 2024 / Notices
Filed Date: 1/18/24.
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ddrumheller on DSK120RN23PROD with NOTICES1
Dated: January 18, 2024.
Debbie-Anne A. Reese,
Acting Secretary.
BILLING CODE 6717–01–P
17:06 Jan 23, 2024
[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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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 https://
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:
barkas.jessica@epa.gov.
For general information contact: The
TSCA–Hotline, ABVI–Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
[FR Doc. 2024–01330 Filed 1–23–24; 8:45 am]
VerDate Sep<11>2014
ENVIRONMENTAL PROTECTION
AGENCY
Jkt 262001
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
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
4605
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
E:\FR\FM\24JAN1.SGM
24JAN1
ddrumheller on DSK120RN23PROD with NOTICES1
4606
Federal Register / Vol. 89, No. 16 / Wednesday, January 24, 2024 / Notices
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
VerDate Sep<11>2014
17:06 Jan 23, 2024
Jkt 262001
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
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2023–0240; FRL–10973–01–
ORD]
Scientific Integrity Policy Draft for
Public Comment
Environmental Protection
Agency (EPA).
ACTION: Notice of public comment
period.
AGENCY:
The U.S. Environmental
Protection Agency (EPA) is announcing
a 30-day public comment period on the
draft updates to its Scientific Integrity
(SI) Policy. In accordance with the
requirements of the 2021 Presidential
Memorandum on Restoring Trust in
Government Through Scientific Integrity
and Evidence-based Policymaking, EPA
is revising our SI Policy. The updated SI
Policy will adopt a new Federal
definition of scientific integrity and
meaningfully strengthen several policy
elements that will help ensure a culture
of scientific integrity at the Agency. It
will incorporate the model scientific
SUMMARY:
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Fmt 4703
Sfmt 4703
integrity policy from the National
Science and Technology Council’s A
Framework for Federal Scientific
Integrity Policy and Practice (2023),
lessons learned over the years, and the
results of previous surveys of EPA staff
on scientific integrity.
DATES: The 30-day public comment
period begins January 24, 2024 and ends
February 23, 2024. Comments must be
received on or before February 23, 2024
to be considered by EPA.
ADDRESSES: You may send comments,
identified by Docket ID No. EPA–HQ–
ORD–2023–0240, by any of the
following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov/ (our
preferred method). Follow the online
instructions for submitting comments.
• Mail: U.S. Environmental
Protection Agency, EPA Docket Center,
Office of Research and Development
Docket, Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington,
DC 20460.
• Hand Delivery or Courier: EPA
Docket Center, WJC West Building,
Room 3334, 1301 Constitution Avenue
NW, Washington, DC 20004. The Docket
Center’s hours of operations are 8:30
a.m. to 4:30 p.m., Monday through
Friday (except Federal Holidays).
Instructions: All submissions received
must include the Docket ID No. for this
action. Comments received may be
posted without change to https://
www.regulations.gov/, including any
personal information provided. For
detailed instructions on sending
comments and additional information,
see the ‘‘Public Participation’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT: For
information on the public comment
period, contact the ORD Docket at the
EPA Headquarters Docket Center;
telephone: 202–566–1752; facsimile:
202–566–9744; or email: Docket_ORD@
epa.gov. For technical information on
the draft guidelines or information on
the public comment period, contact Dr.
Francesca Grifo, via email at:
grifo.francesca@epa.gov; or via phone/
voicemail at 202–657–8575.
SUPPLEMENTARY INFORMATION:
I. Public Participation
Written Comments: Submit your
comments, identified by Docket ID No.
EPA–HQ–ORD–2023–0240, at https://
www.regulations.gov (our preferred
method), or the other methods
identified in the ADDRESSES section.
Once submitted, comments cannot be
edited or removed from the docket. The
EPA may publish any comment received
E:\FR\FM\24JAN1.SGM
24JAN1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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]
BILLING CODE 6560-50-P