Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping Under the Toxic Substances Control Act (TSCA); Change to Submission Period and Technical Correction, 72336-72340 [2024-19931]
Download as PDF
72336
Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Rules and Regulations
for a legislative veto of regulations
promulgated under CERCLA. Although
INS v. Chadha, 462 U.S. 919,103 S. Ct.
2764 (1983), and Bd. of Regents of the
University of Washington v. EPA, 86
F.3d 1214,1222 (D.C. Cir. 1996), cast the
validity of the legislative veto into
question, the EPA has transmitted a
copy of this regulation to the Secretary
of the Senate and the Clerk of the House
of Representatives.
If action by Congress under either the
CRA or CERCLA section 305 calls the
effective date of this regulation into
question, the EPA will publish a
document of clarification in the Federal
Register.
List of Subjects in 40 CFR Part 300
PART 300—NATIONAL OIL AND
HAZARDOUS SUBSTANCES
POLLUTION CONTINGENCY PLAN
Environmental protection, Air
pollution control, Chemicals, Hazardous
substances, Hazardous waste,
Intergovernmental relations, Natural
resources, Oil pollution, Penalties,
Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
1. The authority citation for part 300
continues to read as follows:
■
Authority: 33 U.S.C. 1251 et seq.; 42 U.S.C.
9601–9657; E.O. 13626, 77 FR 56749, 3 CFR,
2013 Comp., p. 306; E.O. 12777, 56 FR 54757,
3 CFR, 1991 Comp., p. 351; E.O. 12580, 52
FR 2923, 3 CFR, 1987 Comp., p. 193.
Barry N. Breen,
Principal Deputy Assistant Administrator,
Office of Land and Emergency Management.
2. Amend table 1 of appendix B to
part 300 by adding an entry for ‘‘CA,
Afterthought Mine’’ in alphabetical
order by State and site name to read as
follows:
■
For the reasons set out in the
preamble, title 40, chapter I, part 300, of
the Code of Federal Regulations is
amended as follows:
Appendix B to Part 300—National
Priorities List
TABLE 1—GENERAL SUPERFUND SECTION
State
Site name
*
CA .......................
*
*
*
Afterthought Mine .......................................................
*
*
City/county
*
Notes (a)
*
*
*
*
*
*
Bella Vista
*
aA
= Based on issuance of health advisory by Agency for Toxic Substances and Disease Registry (if scored, HRS score need not be greater
than or equal to 28.50).
*
*
*
*
*
[FR Doc. 2024–19751 Filed 9–4–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 705
[EPA–HQ–OPPT–2020–0549; FRL–7902.1–
02–OCSPP]
RIN 2070–AK67
Perfluoroalkyl and Polyfluoroalkyl
Substances (PFAS) Data Reporting
and Recordkeeping Under the Toxic
Substances Control Act (TSCA);
Change to Submission Period and
Technical Correction
Environmental Protection
Agency (EPA).
ACTION: Direct final rule; change to
submission period and technical
correction.
AGENCY:
The Environmental Protection
Agency (EPA or Agency) is taking direct
final action to amend the Toxic
Substances Control Act (TSCA)
regulation with reporting and
recordkeeping requirements for
perfluoroalkyl and polyfluoroalkyl
substances (PFAS). As promulgated in
October 2023, the regulation requires
manufacturers (including importers) of
PFAS in any year between 2011–2022 to
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
21:04 Sep 04, 2024
Jkt 262001
report certain data to EPA related to
exposure and environmental and health
effects. EPA is making a one-time
modification to change the beginning of
the data submission period from
November 12, 2024, to July 11, 2025,
with a corresponding change to the end
of the submission period. EPA is also
making a technical correction to address
an error in the regulatory text. There are
no other changes to the reporting and
recordkeeping requirements in the
existing rule under TSCA.
DATES: This rule is effective November
4, 2024 without further notice.
However, if EPA receives adverse
comment by October 7, 2024, the
Agency will publish a timely
withdrawal in the Federal Register
informing the public that this direct
final rule will not take effect.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0549,
online at https://www.regulations.gov.
Follow the online instructions for
submitting comments. Do not submit
electronically any information you
consider to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Additional instructions on commenting
and visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
FOR FURTHER INFORMATION CONTACT:
For technical information: Stephanie
Griffin, Data Gathering, Management,
and Policy Division (7406M), Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: 202–
564–1463; email address:
griffin.stephanie@epa.gov.
For general information: The TSCAHotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620;
telephone number: (202) 554–1404;
email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action may apply to you if you
have manufactured (defined by statute
at 15 U.S.C. 2602(9) to include import)
PFAS for a commercial purpose at any
time since January 1, 2011. 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:
• Construction (NAICS code 23);
• Manufacturing (NAICS codes 31
through 33);
• Wholesale trade (NAICS code 42);
E:\FR\FM\05SER1.SGM
05SER1
khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Rules and Regulations
• Retail trade (NAICS codes 44
through 45); and
• Waste management and
remediation services (NAICS code 562).
This list details the types of entities
that EPA is aware could potentially be
impacted by this action. Other types of
entities not listed could also be
impacted. To determine whether your
entity is impacted by this action, you
should carefully examine the
applicability criteria found in 40 CFR
705.10 and 705.12. If you have
questions regarding the applicability of
this action to a particular entity, consult
the person listed in the FOR FURTHER
INFORMATION CONTACT section (see
above).
Any use of the term ‘‘PFAS’’ will
apply to chemical substances that meet
the structural definition of PFAS
codified at 40 CFR 705. PFAS is defined
as including at least one of these three
structures:
R-(CF2)-CF(R′)R″, where both the CF2
and CF moieties are saturated carbons;
R-CF2 OCF2-R′, where R and R′ can
either be F, O, or saturated carbons; and
CF3 C(CF3)R′R″, where R′ and R″ can
either be F or saturated carbons.
The requirements of this rule also
apply to PFAS manufactured as a
byproduct or impurity or in articles or
mixtures. Further, this rule is not
limited to PFAS currently on the TSCA
Chemical Substance Inventory. For a
more thorough discussion of the
chemical substances included in this
rule, please see Unit III.A. of the final
rulemaking (88 FR 70516, October 11,
2023 (FRL–7902–02–OCSPP)).
This rule does not require reporting
on substances that are excluded from
the definition of ‘‘chemical substance’’
in TSCA section 3(2)(B). Those
exclusions include, but are not limited
to: Any pesticide (as defined by the
Federal Insecticide, Fungicide, and
Rodenticide Act) when manufactured,
processed, or distributed in commerce
for use as a pesticide; any food, food
additive, drug, cosmetic, or device, as
defined by the Federal Food, Drug, and
Cosmetic Act, when manufactured,
processed, or distributed in commerce
for use as a food, food additive, drug,
cosmetic or device; tobacco or any
tobacco product; any source material,
special nuclear material, or byproduct
material as such terms are defined in the
Atomic Energy Act of 1954; and, any
article the sale of which is subject to the
tax imposed by section 4181 of the
Internal Revenue Code of 1954.
B. What is the Agency’s authority for
taking this action?
As with the final rule that published
in the Federal Register of October 11,
VerDate Sep<11>2014
21:04 Sep 04, 2024
Jkt 262001
72337
2023 (88 FR 70516) (FRL–7902–02–
OCSPP)), EPA is promulgating this rule
pursuant to its authority in TSCA
section 8(a)(7) (15 U.S.C. 2607(a)(7)).
The National Defense Authorization Act
for Fiscal Year 2020 (NDAA) (Pub. L.
116–92, section 7351) amended TSCA
section 8(a) in December 2019, adding
TSCA section 8(a)(7), titled ‘‘PFAS
Data.’’ TSCA section 8(a)(7) requires
EPA to promulgate a rule ‘‘requiring
each person who has manufactured a
chemical substance that is a [PFAS] in
any year since January 1, 2011’’ to
report information described in TSCA
section 8(a)(2)(A) through (G). This
includes a broad range of information,
such as information related to chemical
identity and structure, production, use,
byproducts, exposure, disposal, and
health and environmental effects.
TSCA section 14 imposes
requirements for the assertion,
substantiation, and review of
information that is claimed as
confidential business information (CBI).
occurring. Forms that were submitted
prior to the completion of such
continued development could require
resubmission due to the effects of such
ongoing application development.
Similarly, forms that were started but
not yet submitted could need to be
restarted due to the effects of ongoing
application development.
The Agency further anticipates being
able to review submitted data, including
CBI claims, and prepare non-CBI data
for broader dissemination more
efficiently if the full data collection
infrastructure is established prior to the
start of the submission period. Further,
this action is consistent with the public
interest because it is designed to
facilitate compliance with the rule and
to ensure that the collection includes
accurate data on manufactured PFAS in
the United States. Any impact on the
regulated community is expected to be
beneficial given that the extension
provides additional time to submit
accurate reports to EPA.
C. What action is the Agency taking?
EPA is issuing this amendment to
change the data submission period for
the TSCA section 8(a)(7) PFAS reporting
rule that is codified in 40 CFR part 705,
by changing the start date to July 11,
2025, and making corresponding
changes to the end dates for the
submission period. For reasons detailed
in Unit II., the Agency is compelled to
take this action in response to
constraints on the timely development
and testing of the software being
developed to collect information
pursuant to this reporting rule (i.e., the
rule’s reporting application). EPA is also
taking action to correct an inadvertent
error in the rulemaking by revising the
text ‘‘published study reports’’ under
the requirement to submit Organization
for the Economic Cooperation and
Development’s (OECD) Harmonised
Templates (OHTs) to the correct
requirement of submitting OHTs for
‘‘unpublished study reports.’’ EPA
intended to require OHTs only for
unpublished study reports and is
correcting the text accordingly.
This action does not alter any other
aspect of the TSCA section 8(a)(7) PFAS
rule in 40 CFR part 705. This action will
result in additional time for the
Agency’s reporting application to be
completed and sufficiently tested to
ensure that reporting entities do not
experience issues that prevent their
submission of data as required under
TSCA section 8(a)(7) during the
regulatory submission period. Further,
without modifying the reporting period,
EPA would need to continue to develop
the application while reporting is
D. Why is the Agency using a direct final
rule?
EPA is taking direct final action
because the Agency views this as a
noncontroversial action and anticipates
no adverse comment. Although EPA
continues to devote significant
resources to development of the
reporting application, EPA will not be
in a position to accept data in a usable
manner under the current start date of
November 12, 2024, and thus it will be
impossible for submitters to begin to
submit data on that date. For reasons
detailed in Unit II., the reporting
timeline is no longer tenable and
maintaining that deadline would require
entities to submit data before EPA has
the technological capacity in place to
accept that data. This would negatively
impact EPA’s ability to collect, organize,
and make the collected data available to
the public, which is the underlying
objective of the regulation as well as the
Congressional direction that required its
promulgation.
This action also includes a technical
correction to revise an error in the
regulatory text. At 40 CFR 705.15(f)(1),
the requirement for PFAS manufacturers
to submit all existing information
concerning the environmental or health
effects of that PFAS stipulates that the
OHTs must be completed for ‘‘each
published study report’’ [emphasis
added]. EPA’s intent was to require
OHTs and supporting information for
unpublished study reports, as those are
not publicly available in open literature
(see 88 FR at 70524). Thus, this action
also revises the word ‘‘published’’ to
‘‘unpublished’’ at 40 CFR 705.15(f)(1).
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
E:\FR\FM\05SER1.SGM
05SER1
72338
Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Rules and Regulations
In the ‘‘Proposed Rules’’ section of
this issue of the Federal Register, EPA
is publishing a separate document that
will serve as the proposed rule to amend
the beginning of the submission period
if adverse comments are received on
this direct final rule. EPA will not
institute a second comment period on
this action. Any parties interested in
commenting must do so at this time. For
further information about commenting
on this rule, see the ADDRESSES section
of the document in the ‘‘Proposed
Rules’’ section of this Federal Register
publication.
If EPA receives adverse comment, the
Agency will publish a timely
withdrawal in the Federal Register
informing the public that this direct
final rule will not take effect. In this
case, EPA would address all public
comments in a subsequent final rule.
EPA reiterates that there is no feasible
way to begin collecting the TSCA
section 8(a)(7) dataset by November 12,
2024, so maintaining the current
submission period timeline is not
tenable.
khammond on DSKJM1Z7X2PROD with RULES
II. Background
A. What is the modification to the
submission period?
The 2016 Frank R. Lautenberg
Chemical Safety for the 21st Century
Act (Lautenberg Act) considerably
expanded the scope of EPA’s
responsibilities under TSCA. The
amendments require EPA to
systematically and comprehensively
prioritize and evaluate at least 20
chemicals at the same time and provide
protections against the identified
unreasonable risks through regulations.
Under the amended law, EPA is also
required to complete formal risk
determinations for 100 percent of all
new chemical submissions, as compared
to the pre-2016 practice of completing
formal risk determinations on about 20
percent of such submissions. The
amended law also provides new
responsibility for increasing
transparency and new data-gathering
authority to support the Agency
assessments. EPA’s appropriated
resources for implementing TSCA have
not kept pace with the Agency’s
activities and obligations under
amended TSCA. For example, the
enacted budget for fiscal year 2024
resulted in an $8.4 million reduction to
contracts and other non-payroll TSCA
funding levels when compared with
funding for fiscal year 2023 (a ∼33%
reduction).
As described in this unit, this
increased responsibility alongside
reduced funding has forced EPA to
VerDate Sep<11>2014
21:04 Sep 04, 2024
Jkt 262001
make difficult choices, including delays
in activities that impact the Agency’s
ability to collect data for the TSCA
section 8(a)(7) requirement during the
reporting period that had been
anticipated when the Agency
promulgated the rule.
Nearly all TSCA regulatory
submissions are required to be
submitted through EPA’s Central Data
Exchange (CDX). CDX provides EPA’s
interface with data submitters,
including fulfillment of all legal
requirements for electronic submittals
as set out by the Cross-Media Electronic
Reporting Rule (CROMERR) (40 CFR
part 3).
When EPA uses CDX to collect
information, the Agency must also
develop a corresponding application in
its TSCA CBI environment, which is
used to manage the final validation and
processing of submitted content. Each
submission to CDX is transmitted into
the appropriate TSCA CBI application
for further processing, storage, and use.
After successfully processing a
submission, a secure message is sent
back to CDX, which updates the
submission status to ‘‘submitted’’ and
provides a Case Number to the
submitter for their reference. Functional
CDX and CBI applications are necessary
for a regulated entity to fully and legally
submit the required information to EPA
and demonstrate compliance with the
regulation under which the information
was submitted.
Under the NDAA, EPA was directed
to write the final rule that was
published on October 11, 2023 (88 FR
70516 (FRL–7902–02–OCSPP)). EPA’s
obligation under the NDAA to use its
TSCA section 8 authority is critical to
the Agency’s understanding of PFAS in
commerce. The information required
under the TSCA section 8(a)(7) rule will
create a comprehensive database of
previously manufactured PFAS in
commerce and support EPA’s actions to
address PFAS exposure and
contamination.
From a TSCA perspective, the amount
of data that is expected to be submitted
under this rule is unprecedented due to
the number of chemicals and years of
data for which this reporting
requirement applies, underscoring the
critical need to ensure the fidelity of the
process and the data, which can only be
achieved by delaying the start of the
reporting period. To fully ensure the
Agency’s reporting platform can manage
this volume of materials, an industry
testing period will be required. This is
built into the new timeline with a
sufficient window to allow for software
updates and modifications based upon
this testing.
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
For technical reasons explained in
Unit II. B., EPA must delay the data
submission period of this rule. EPA will
not be able to accept, confirm receipt,
and ensure fidelity of reported PFAS
information at the original reporting
start date of November 12, 2024. It is in
the interest of the general public and
industry that EPA move the start of the
reporting period from November 12,
2024, to July 11, 2025, to ensure that the
infrastructure underlying the data
collection process is working optimally,
thus ensuring ultimate public access, as
appropriate, to this information. It is for
these reasons that EPA, as a matter of
good governance, must postpone the
submission periods codified in the final
rule (88 FR 70516, October 11, 2023
(FRL–7902–02–OCSPP)). As codified,
this includes a start and end date for
submission, including an alternate end
date for small entities.
B. Why is the Agency modifying the data
submission period?
Due to increased statutory obligations
across the TSCA Existing and New
Chemicals programs and a lack of
increased resources to meet those
obligations, including a 5 percent
reduction to the TSCA program in Fiscal
Year 2024 compared to what was
appropriated in Fiscal Year 2023 and an
unfunded Cost of Living Adjustment for
FY 2024, EPA’s Office of Pollution
Prevention and Toxics (OPPT) was
forced to make difficult choices to
ensure that the program was able to
continue its work to protect human
health and the environment from the
risks presented by toxic chemical
substances. Because of this challenge, as
a result of competing priorities for
information technology/information
management (IT/IM) resources, and in
response to the uncertainties associated
with working under three successive
Continuing Resolutions that lasted
through March 9, 2024, which resulted
in EPA receiving funding via 30-day
increments and thus, due to the lack of
a budget, being unable to project
funding availability for the year, OPPT
was forced to significantly reduce its IT/
IM operating budget in FY2024 to
prevent overspending of resources.
Software development efforts in process
and operations and maintenance
activities associated with both CDX and
TSCA CBI-based applications, which are
critical to the Agency’s TSCA data
collections, including the data collected
under this rule, were impacted by these
reductions, resulting in increased costs
due to unforeseen complications arising
with existing software applications as
well as forecasted resource needs for
developing new software applications.
E:\FR\FM\05SER1.SGM
05SER1
khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Rules and Regulations
The reduced funding for this work
would primarily have been used for the
contractual support on which EPA relies
for much of its IT/IM efforts.
Because the decrease in resources
impacted the funds available for
contractor support, EPA’s contractors
reduced their effort on the TSCA
information technology software and
related portfolio by more than 50
percent, which had significant,
immediate implications for EPA’s
ability to make progress on many of its
IT/IM projects. Most significantly for
this rule, software development needed
to be re-prioritized so only those
projects with the nearest-term deadlines
received resources and effort. For
example, when the asbestos reporting
application had to be developed by
spring 2024, contractor staff supporting
other applications (e.g., TSCA section
8(a)(7), Chemical Data Reporting (CDR),
and operations and maintenance) were
re-allocated to that effort. Additionally,
the asbestos reporting application
required additional support beyond
what was initially anticipated due to
CBI-related reporting nuances that took
more resources, including time, to
implement and delayed the receipt of
reporting for that rule. This process of
focusing development on reporting
requirements with the nearest-term
deadlines was shortly thereafter
repeated in support of the 2024 CDR
reporting cycle, which began on June 1,
2024. EPA was only able to allocate
resources for development of the
reporting application for this TSCA
section 8(a)(7) rule in May 2024. These
resources immediately went to
reassembling, training, and additional
onboarding of the team (staff had been
previously transitioned from the TSCA
section 8(a)(7) reporting application due
to the re-prioritizing activities described
above). These activities were completed
in June 2024, by which time developing
a fully functioning reporting tool by the
submission period date in the TSCA
section 8(a)(7) final rule was impossible
due to the significant amount of
development required to ensure that the
application would fully support the
required data elements, including the
ability to make, as applicable, associated
CBI claims. (88 FR 70516 October 11,
2023 (FRL–7902–02–OCSPP)). Further,
EPA typically conducts testing prior to
making an application available, and in
response to users having difficulties
using some of the other recent TSCA
applications (e.g., the application for
asbestos reporting), ensuring that the
Agency has adequate time to test the
TSCA section 8(a)(7) PFAS reporting
application is critical. Relatedly, EPA
VerDate Sep<11>2014
21:04 Sep 04, 2024
Jkt 262001
has committed to providing interested
industry stakeholders an opportunity to
help test the application to ensure that
it could collect the data as intended,
which the timeline for the current
reporting period does not allow.
To ensure functioning reporting
capability, EPA must extend the
development project timeline.
Accordingly, the reporting tool will be
available beginning July 11, 2025. This
action will maintain all other reporting
obligations under TSCA section 8(a)(7),
and reporters will still have the same
amount of time to submit data as
codified at 40 CFR 705.
C. What is the technical correction?
Additionally, EPA is using this action
to amend a typographical error in the
regulation’s paragraph related to the
submission of OHTs. The regulatory text
at 40 CFR 705.15(f)(1) currently states
that OHTs are required for ‘‘published
study reports.’’ Requiring OHTs for
published study reports was not the
intent of the final rule, nor would this
yield any benefits, if submitters are not
required to submit information that is in
open scientific literature. This phrase
should have read ‘‘unpublished study
reports,’’ which is consistent with EPA’s
explanation in the final rule preamble:
‘‘EPA is not requiring manufacturers to
search open scientific literature to find
relevant information on a PFAS that was
previously not in their possession or
control for the purpose of this rule. EPA
believes that implementing such a
requirement may result in duplicative
information, if multiple PFAS
manufacturers are submitting the same
studies or other information that are
available publicly (including in EPA’s
scientific literature databases)’’ (88 FR
70524, October 11, 2023 (7902–02–
OCSPP)).
IV. Statutory and Executive Orders
Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 14094: Modernizing Regulatory
Review
This action is not a significant
regulatory action as defined in
Executive Order 12866(58 FR 51735,
October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879,
April 11, 2023), and was therefore not
subject to Executive Order 12866
review.
B. Paperwork Reduction Act (PRA)
This action does not contain any new
information collection burden under the
PRA, 44 U.S.C. 3501 et seq. OMB has
previously approved the information
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
72339
collection activities contained in the
existing regulations and has assigned
OMB control number 2070–0217 (EPA
ICR No. 2682.02). This action does not
create any new reporting or
recordkeeping obligations, and does not
otherwise change the burden estimates
that were approved.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA, 5 U.S.C. 601 et seq. In
making this determination, EPA
concludes that the impact of concern for
this action is any significant adverse
economic impact on small entities and
that the agency is certifying that this
action will not have a significant
economic impact on a substantial
number of small entities because the
rule has no net burden on the small
entities subject to the rule. This direct
final rule provides the same timeframe
for reporting, while delaying the start
date and otherwise adds no new
reporting requirements. This action only
postpones the start of the information
submission period already required and
makes a technical correction to the
regulatory text. We have therefore
concluded that this action will have no
net regulatory burden for all directly
regulated small entities.
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million (in
1995 dollars and adjusted annually for
inflation) or more as described in
UMRA, 2. U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. The action imposes no
enforceable duty on any State, local or
Tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999), because it will not have
substantial direct effects on the states,
on the relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have Tribal
implications as specified in Executive
Order 1317(65 FR 67249, November 9,
2000), because it will not have
substantial direct effects on Tribal
governments, on the relationship
E:\FR\FM\05SER1.SGM
05SER1
72340
Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Rules and Regulations
between the Federal Government and
the Indian Tribes, or on the distribution
of power and responsibilities between
the Federal Government and Indian
Tribes. This action does not impose
substantial direct compliance costs on
federally recognized Indian tribal
governments. Thus, Executive Order
13175 does not apply to this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 (62 FR 19885, April 23,
1997), because it does not concern an
environmental health or safety risk.
Since this action does not concern
human health, EPA’s Policy on
Children’s Health also does not apply.
Although this does not concern an
environmental health or safety risk and
does not materially alter the reporting
requirements under TSCA section
8(a)(7), EPA believes that the one-time
data collection imposed in the 2023
final rule will aid in collecting all
existing and reasonably ascertainable
information related to the
manufacturing (including importing) of
PFAS since 2011. As noted in the 2023
final rule, this one-time collection will
help identify data gaps surrounding the
knowledge of commercially
manufactured PFAS. Understanding the
extent of existing data gaps related to
manufactured PFAS will also help
inform and tailor future EPA actions to
address PFAS as needed. The one-time
collection will provide information on
the quantity of PFAS to which children
may be exposed. EPA believes that the
information obtained as a result of this
one-time data collection could also be
used by the public, government agencies
and others to identify potential
problems, set priorities, and take
appropriate steps to reduce any
potential human health or
environmental risks, including potential
risks to children.
khammond on DSKJM1Z7X2PROD with RULES
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution or Use
This action does not involve technical
standards under the NTTAA section
12(d), 15 U.S.C. 272.
Jkt 262001
List of Subjects in 40 CFR Part 705
Chemicals, Environmental protection,
Reporting and recordkeeping
requirements.
Dated: August 29, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
Therefore, for the reasons set forth in
the preamble, 40 CFR part 705 is
amended as follows:
PART 705—REPORTING AND
RECORDKEEPING REQUIREMENTS
FOR CERTAIN PER- AND
POLYFLUOROALKYL SUBSTANCES
1. The authority for part 705
continues to read as follows
■
Authority: 42 U.S.C. 2607(a)(7).
2. Amend § 705.15 by revising
paragraph (f)(1) to read as follows:
■
What information to report.
*
I. National Technology Transfer and
Advancement Act (NTTAA)
21:04 Sep 04, 2024
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5
U.S.C. 801 et seq., and EPA will submit
a rule report to each House of the
Congress and to the Comptroller General
of the United States. This does not meet
the criteria set forth in 5 U.S.C. 804(2).
§ 705.15
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 28355, May 22,
2001), because it is not likely to have
any adverse effect on the supply,
distribution or use of energy.
VerDate Sep<11>2014
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations and Executive
Order 14096: Revitalizing Our Nation’s
Commitment to Environmental Justice
for All
The EPA believes that this type of
action does not concern human health
or environmental conditions and
therefore cannot be evaluated with
respect to potentially disproportionate
and adverse effects on communities
with environmental justice concerns in
accordance with Executive Orders
12898 (59 FR 7629, February 16, 1994)
and 14096 (88 FR 25251, April 26,
2023). This action does not materially
alter the reporting requirements under
TSCA section 8(a)(7), as discussed in
Unit II.
*
*
*
*
(f) * * *
(1) Organization for Economic
Cooperation and Development (OECD)
Harmonized Templates. For each
unpublished study report, the submitter
shall complete an OECD Harmonized
Templates for Reporting Chemical Test
Summaries and submit the
accompanying study reports and
supporting information. This can be
accomplished by using the freely
available IUCLID software.
*
*
*
*
*
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
■
3. Revise § 705.20 to read as follows:
§ 705.20
When to report.
All information reported to EPA in
response to the requirements of this part
must be submitted during the applicable
submission period. For all reporters
submitting information pursuant to
§§ 705.15 and 705.18(b) (research and
development), the submission period
shall begin on July 11, 2025, and last for
six months: July 11, 2025, through
January 11, 2026. For any reporter who
is reporting under this part exclusively
pursuant to § 705.18(a) (article
importers), and is also considered a
small manufacturer under the definition
at 40 CFR 704.3, the submission period
shall begin on July 11, 2025, and last for
12 months: July 11, 2025, through July
11, 2026.
[FR Doc. 2024–19931 Filed 9–4–24; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 240227–0061; RTID 0648–
XE219]
Fisheries of the Exclusive Economic
Zone Off Alaska; Pacific Cod by
Catcher Vessels Using Trawl Gear in
the Central Regulatory Area of the Gulf
of Alaska
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
NMFS is prohibiting directed
fishing for Pacific cod by catcher vessels
using trawl gear in the Central
Regulatory Area of the Gulf of Alaska
(GOA). This action is necessary to
prevent exceeding the 2024 total
allowable catch of Pacific cod by catcher
vessels using trawl gear in the Central
Regulatory Area of the GOA.
DATES: Effective 1200 hours, Alaska
local time (A.l.t.), September 1, 2024,
through 2400 hours, A.l.t., December 31,
2024.
FOR FURTHER INFORMATION CONTACT:
Abby Jahn, 907–586–7228.
SUPPLEMENTARY INFORMATION: NMFS
manages the groundfish fishery in the
GOA exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Gulf of
Alaska (FMP) prepared by the North
Pacific Fishery Management Council
SUMMARY:
E:\FR\FM\05SER1.SGM
05SER1
Agencies
[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Rules and Regulations]
[Pages 72336-72340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19931]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 705
[EPA-HQ-OPPT-2020-0549; FRL-7902.1-02-OCSPP]
RIN 2070-AK67
Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data
Reporting and Recordkeeping Under the Toxic Substances Control Act
(TSCA); Change to Submission Period and Technical Correction
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule; change to submission period and technical
correction.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or Agency) is taking
direct final action to amend the Toxic Substances Control Act (TSCA)
regulation with reporting and recordkeeping requirements for
perfluoroalkyl and polyfluoroalkyl substances (PFAS). As promulgated in
October 2023, the regulation requires manufacturers (including
importers) of PFAS in any year between 2011-2022 to report certain data
to EPA related to exposure and environmental and health effects. EPA is
making a one-time modification to change the beginning of the data
submission period from November 12, 2024, to July 11, 2025, with a
corresponding change to the end of the submission period. EPA is also
making a technical correction to address an error in the regulatory
text. There are no other changes to the reporting and recordkeeping
requirements in the existing rule under TSCA.
DATES: This rule is effective November 4, 2024 without further notice.
However, if EPA receives adverse comment by October 7, 2024, the Agency
will publish a timely withdrawal in the Federal Register informing the
public that this direct final rule will not take effect.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0549, online at https://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Additional instructions on
commenting and 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: Stephanie Griffin, Data Gathering,
Management, and Policy Division (7406M), Office of Pollution Prevention
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: 202-564-1463; email
address: [email protected].
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action may apply to you if you have manufactured (defined by
statute at 15 U.S.C. 2602(9) to include import) PFAS for a commercial
purpose at any time since January 1, 2011. 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:
Construction (NAICS code 23);
Manufacturing (NAICS codes 31 through 33);
Wholesale trade (NAICS code 42);
[[Page 72337]]
Retail trade (NAICS codes 44 through 45); and
Waste management and remediation services (NAICS code
562).
This list details the types of entities that EPA is aware could
potentially be impacted by this action. Other types of entities not
listed could also be impacted. To determine whether your entity is
impacted by this action, you should carefully examine the applicability
criteria found in 40 CFR 705.10 and 705.12. If you have questions
regarding the applicability of this action to a particular entity,
consult the person listed in the FOR FURTHER INFORMATION CONTACT
section (see above).
Any use of the term ``PFAS'' will apply to chemical substances that
meet the structural definition of PFAS codified at 40 CFR 705. PFAS is
defined as including at least one of these three structures:
R-(CF2)-CF(R')R'', where both the CF2 and CF
moieties are saturated carbons;
R-CF2 OCF2-R', where R and R' can either be
F, O, or saturated carbons; and
CF3 C(CF3)R'R'', where R' and R'' can either
be F or saturated carbons.
The requirements of this rule also apply to PFAS manufactured as a
byproduct or impurity or in articles or mixtures. Further, this rule is
not limited to PFAS currently on the TSCA Chemical Substance Inventory.
For a more thorough discussion of the chemical substances included in
this rule, please see Unit III.A. of the final rulemaking (88 FR 70516,
October 11, 2023 (FRL-7902-02-OCSPP)).
This rule does not require reporting on substances that are
excluded from the definition of ``chemical substance'' in TSCA section
3(2)(B). Those exclusions include, but are not limited to: Any
pesticide (as defined by the Federal Insecticide, Fungicide, and
Rodenticide Act) when manufactured, processed, or distributed in
commerce for use as a pesticide; any food, food additive, drug,
cosmetic, or device, as defined by the Federal Food, Drug, and Cosmetic
Act, when manufactured, processed, or distributed in commerce for use
as a food, food additive, drug, cosmetic or device; tobacco or any
tobacco product; any source material, special nuclear material, or
byproduct material as such terms are defined in the Atomic Energy Act
of 1954; and, any article the sale of which is subject to the tax
imposed by section 4181 of the Internal Revenue Code of 1954.
B. What is the Agency's authority for taking this action?
As with the final rule that published in the Federal Register of
October 11, 2023 (88 FR 70516) (FRL-7902-02-OCSPP)), EPA is
promulgating this rule pursuant to its authority in TSCA section
8(a)(7) (15 U.S.C. 2607(a)(7)). The National Defense Authorization Act
for Fiscal Year 2020 (NDAA) (Pub. L. 116-92, section 7351) amended TSCA
section 8(a) in December 2019, adding TSCA section 8(a)(7), titled
``PFAS Data.'' TSCA section 8(a)(7) requires EPA to promulgate a rule
``requiring each person who has manufactured a chemical substance that
is a [PFAS] in any year since January 1, 2011'' to report information
described in TSCA section 8(a)(2)(A) through (G). This includes a broad
range of information, such as information related to chemical identity
and structure, production, use, byproducts, exposure, disposal, and
health and environmental effects.
TSCA section 14 imposes requirements for the assertion,
substantiation, and review of information that is claimed as
confidential business information (CBI).
C. What action is the Agency taking?
EPA is issuing this amendment to change the data submission period
for the TSCA section 8(a)(7) PFAS reporting rule that is codified in 40
CFR part 705, by changing the start date to July 11, 2025, and making
corresponding changes to the end dates for the submission period. For
reasons detailed in Unit II., the Agency is compelled to take this
action in response to constraints on the timely development and testing
of the software being developed to collect information pursuant to this
reporting rule (i.e., the rule's reporting application). EPA is also
taking action to correct an inadvertent error in the rulemaking by
revising the text ``published study reports'' under the requirement to
submit Organization for the Economic Cooperation and Development's
(OECD) Harmonised Templates (OHTs) to the correct requirement of
submitting OHTs for ``unpublished study reports.'' EPA intended to
require OHTs only for unpublished study reports and is correcting the
text accordingly.
This action does not alter any other aspect of the TSCA section
8(a)(7) PFAS rule in 40 CFR part 705. This action will result in
additional time for the Agency's reporting application to be completed
and sufficiently tested to ensure that reporting entities do not
experience issues that prevent their submission of data as required
under TSCA section 8(a)(7) during the regulatory submission period.
Further, without modifying the reporting period, EPA would need to
continue to develop the application while reporting is occurring. Forms
that were submitted prior to the completion of such continued
development could require resubmission due to the effects of such
ongoing application development. Similarly, forms that were started but
not yet submitted could need to be restarted due to the effects of
ongoing application development.
The Agency further anticipates being able to review submitted data,
including CBI claims, and prepare non-CBI data for broader
dissemination more efficiently if the full data collection
infrastructure is established prior to the start of the submission
period. Further, this action is consistent with the public interest
because it is designed to facilitate compliance with the rule and to
ensure that the collection includes accurate data on manufactured PFAS
in the United States. Any impact on the regulated community is expected
to be beneficial given that the extension provides additional time to
submit accurate reports to EPA.
D. Why is the Agency using a direct final rule?
EPA is taking direct final action because the Agency views this as
a noncontroversial action and anticipates no adverse comment. Although
EPA continues to devote significant resources to development of the
reporting application, EPA will not be in a position to accept data in
a usable manner under the current start date of November 12, 2024, and
thus it will be impossible for submitters to begin to submit data on
that date. For reasons detailed in Unit II., the reporting timeline is
no longer tenable and maintaining that deadline would require entities
to submit data before EPA has the technological capacity in place to
accept that data. This would negatively impact EPA's ability to
collect, organize, and make the collected data available to the public,
which is the underlying objective of the regulation as well as the
Congressional direction that required its promulgation.
This action also includes a technical correction to revise an error
in the regulatory text. At 40 CFR 705.15(f)(1), the requirement for
PFAS manufacturers to submit all existing information concerning the
environmental or health effects of that PFAS stipulates that the OHTs
must be completed for ``each published study report'' [emphasis added].
EPA's intent was to require OHTs and supporting information for
unpublished study reports, as those are not publicly available in open
literature (see 88 FR at 70524). Thus, this action also revises the
word ``published'' to ``unpublished'' at 40 CFR 705.15(f)(1).
[[Page 72338]]
In the ``Proposed Rules'' section of this issue of the Federal
Register, EPA is publishing a separate document that will serve as the
proposed rule to amend the beginning of the submission period if
adverse comments are received on this direct final rule. EPA will not
institute a second comment period on this action. Any parties
interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
the document in the ``Proposed Rules'' section of this Federal Register
publication.
If EPA receives adverse comment, the Agency will publish a timely
withdrawal in the Federal Register informing the public that this
direct final rule will not take effect. In this case, EPA would address
all public comments in a subsequent final rule. EPA reiterates that
there is no feasible way to begin collecting the TSCA section 8(a)(7)
dataset by November 12, 2024, so maintaining the current submission
period timeline is not tenable.
II. Background
A. What is the modification to the submission period?
The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century
Act (Lautenberg Act) considerably expanded the scope of EPA's
responsibilities under TSCA. The amendments require EPA to
systematically and comprehensively prioritize and evaluate at least 20
chemicals at the same time and provide protections against the
identified unreasonable risks through regulations. Under the amended
law, EPA is also required to complete formal risk determinations for
100 percent of all new chemical submissions, as compared to the pre-
2016 practice of completing formal risk determinations on about 20
percent of such submissions. The amended law also provides new
responsibility for increasing transparency and new data-gathering
authority to support the Agency assessments. EPA's appropriated
resources for implementing TSCA have not kept pace with the Agency's
activities and obligations under amended TSCA. For example, the enacted
budget for fiscal year 2024 resulted in an $8.4 million reduction to
contracts and other non-payroll TSCA funding levels when compared with
funding for fiscal year 2023 (a ~33% reduction).
As described in this unit, this increased responsibility alongside
reduced funding has forced EPA to make difficult choices, including
delays in activities that impact the Agency's ability to collect data
for the TSCA section 8(a)(7) requirement during the reporting period
that had been anticipated when the Agency promulgated the rule.
Nearly all TSCA regulatory submissions are required to be submitted
through EPA's Central Data Exchange (CDX). CDX provides EPA's interface
with data submitters, including fulfillment of all legal requirements
for electronic submittals as set out by the Cross-Media Electronic
Reporting Rule (CROMERR) (40 CFR part 3).
When EPA uses CDX to collect information, the Agency must also
develop a corresponding application in its TSCA CBI environment, which
is used to manage the final validation and processing of submitted
content. Each submission to CDX is transmitted into the appropriate
TSCA CBI application for further processing, storage, and use. After
successfully processing a submission, a secure message is sent back to
CDX, which updates the submission status to ``submitted'' and provides
a Case Number to the submitter for their reference. Functional CDX and
CBI applications are necessary for a regulated entity to fully and
legally submit the required information to EPA and demonstrate
compliance with the regulation under which the information was
submitted.
Under the NDAA, EPA was directed to write the final rule that was
published on October 11, 2023 (88 FR 70516 (FRL-7902-02-OCSPP)). EPA's
obligation under the NDAA to use its TSCA section 8 authority is
critical to the Agency's understanding of PFAS in commerce. The
information required under the TSCA section 8(a)(7) rule will create a
comprehensive database of previously manufactured PFAS in commerce and
support EPA's actions to address PFAS exposure and contamination.
From a TSCA perspective, the amount of data that is expected to be
submitted under this rule is unprecedented due to the number of
chemicals and years of data for which this reporting requirement
applies, underscoring the critical need to ensure the fidelity of the
process and the data, which can only be achieved by delaying the start
of the reporting period. To fully ensure the Agency's reporting
platform can manage this volume of materials, an industry testing
period will be required. This is built into the new timeline with a
sufficient window to allow for software updates and modifications based
upon this testing.
For technical reasons explained in Unit II. B., EPA must delay the
data submission period of this rule. EPA will not be able to accept,
confirm receipt, and ensure fidelity of reported PFAS information at
the original reporting start date of November 12, 2024. It is in the
interest of the general public and industry that EPA move the start of
the reporting period from November 12, 2024, to July 11, 2025, to
ensure that the infrastructure underlying the data collection process
is working optimally, thus ensuring ultimate public access, as
appropriate, to this information. It is for these reasons that EPA, as
a matter of good governance, must postpone the submission periods
codified in the final rule (88 FR 70516, October 11, 2023 (FRL-7902-02-
OCSPP)). As codified, this includes a start and end date for
submission, including an alternate end date for small entities.
B. Why is the Agency modifying the data submission period?
Due to increased statutory obligations across the TSCA Existing and
New Chemicals programs and a lack of increased resources to meet those
obligations, including a 5 percent reduction to the TSCA program in
Fiscal Year 2024 compared to what was appropriated in Fiscal Year 2023
and an unfunded Cost of Living Adjustment for FY 2024, EPA's Office of
Pollution Prevention and Toxics (OPPT) was forced to make difficult
choices to ensure that the program was able to continue its work to
protect human health and the environment from the risks presented by
toxic chemical substances. Because of this challenge, as a result of
competing priorities for information technology/information management
(IT/IM) resources, and in response to the uncertainties associated with
working under three successive Continuing Resolutions that lasted
through March 9, 2024, which resulted in EPA receiving funding via 30-
day increments and thus, due to the lack of a budget, being unable to
project funding availability for the year, OPPT was forced to
significantly reduce its IT/IM operating budget in FY2024 to prevent
overspending of resources. Software development efforts in process and
operations and maintenance activities associated with both CDX and TSCA
CBI-based applications, which are critical to the Agency's TSCA data
collections, including the data collected under this rule, were
impacted by these reductions, resulting in increased costs due to
unforeseen complications arising with existing software applications as
well as forecasted resource needs for developing new software
applications.
[[Page 72339]]
The reduced funding for this work would primarily have been used for
the contractual support on which EPA relies for much of its IT/IM
efforts.
Because the decrease in resources impacted the funds available for
contractor support, EPA's contractors reduced their effort on the TSCA
information technology software and related portfolio by more than 50
percent, which had significant, immediate implications for EPA's
ability to make progress on many of its IT/IM projects. Most
significantly for this rule, software development needed to be re-
prioritized so only those projects with the nearest-term deadlines
received resources and effort. For example, when the asbestos reporting
application had to be developed by spring 2024, contractor staff
supporting other applications (e.g., TSCA section 8(a)(7), Chemical
Data Reporting (CDR), and operations and maintenance) were re-allocated
to that effort. Additionally, the asbestos reporting application
required additional support beyond what was initially anticipated due
to CBI-related reporting nuances that took more resources, including
time, to implement and delayed the receipt of reporting for that rule.
This process of focusing development on reporting requirements with the
nearest-term deadlines was shortly thereafter repeated in support of
the 2024 CDR reporting cycle, which began on June 1, 2024. EPA was only
able to allocate resources for development of the reporting application
for this TSCA section 8(a)(7) rule in May 2024. These resources
immediately went to reassembling, training, and additional onboarding
of the team (staff had been previously transitioned from the TSCA
section 8(a)(7) reporting application due to the re-prioritizing
activities described above). These activities were completed in June
2024, by which time developing a fully functioning reporting tool by
the submission period date in the TSCA section 8(a)(7) final rule was
impossible due to the significant amount of development required to
ensure that the application would fully support the required data
elements, including the ability to make, as applicable, associated CBI
claims. (88 FR 70516 October 11, 2023 (FRL-7902-02-OCSPP)). Further,
EPA typically conducts testing prior to making an application
available, and in response to users having difficulties using some of
the other recent TSCA applications (e.g., the application for asbestos
reporting), ensuring that the Agency has adequate time to test the TSCA
section 8(a)(7) PFAS reporting application is critical. Relatedly, EPA
has committed to providing interested industry stakeholders an
opportunity to help test the application to ensure that it could
collect the data as intended, which the timeline for the current
reporting period does not allow.
To ensure functioning reporting capability, EPA must extend the
development project timeline. Accordingly, the reporting tool will be
available beginning July 11, 2025. This action will maintain all other
reporting obligations under TSCA section 8(a)(7), and reporters will
still have the same amount of time to submit data as codified at 40 CFR
705.
C. What is the technical correction?
Additionally, EPA is using this action to amend a typographical
error in the regulation's paragraph related to the submission of OHTs.
The regulatory text at 40 CFR 705.15(f)(1) currently states that OHTs
are required for ``published study reports.'' Requiring OHTs for
published study reports was not the intent of the final rule, nor would
this yield any benefits, if submitters are not required to submit
information that is in open scientific literature. This phrase should
have read ``unpublished study reports,'' which is consistent with EPA's
explanation in the final rule preamble: ``EPA is not requiring
manufacturers to search open scientific literature to find relevant
information on a PFAS that was previously not in their possession or
control for the purpose of this rule. EPA believes that implementing
such a requirement may result in duplicative information, if multiple
PFAS manufacturers are submitting the same studies or other information
that are available publicly (including in EPA's scientific literature
databases)'' (88 FR 70524, October 11, 2023 (7902-02-OCSPP)).
IV. Statutory and Executive Orders Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action is not a significant regulatory action as defined in
Executive Order 12866(58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore
not subject to Executive Order 12866 review.
B. Paperwork Reduction Act (PRA)
This action does not contain any new information collection burden
under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the
information collection activities contained in the existing regulations
and has assigned OMB control number 2070-0217 (EPA ICR No. 2682.02).
This action does not create any new reporting or recordkeeping
obligations, and does not otherwise change the burden estimates that
were approved.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this action is any significant adverse economic
impact on small entities and that the agency is certifying that this
action will not have a significant economic impact on a substantial
number of small entities because the rule has no net burden on the
small entities subject to the rule. This direct final rule provides the
same timeframe for reporting, while delaying the start date and
otherwise adds no new reporting requirements. This action only
postpones the start of the information submission period already
required and makes a technical correction to the regulatory text. We
have therefore concluded that this action will have no net regulatory
burden for all directly regulated small entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million
(in 1995 dollars and adjusted annually for inflation) or more as
described in UMRA, 2. U.S.C. 1531-1538, and does not significantly or
uniquely affect small governments. The action imposes no enforceable
duty on any State, local or Tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 1317(65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on Tribal governments, on the
relationship
[[Page 72340]]
between the Federal Government and the Indian Tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian Tribes. This action does not impose substantial
direct compliance costs on federally recognized Indian tribal
governments. Thus, Executive Order 13175 does not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern human health, EPA's
Policy on Children's Health also does not apply. Although this does not
concern an environmental health or safety risk and does not materially
alter the reporting requirements under TSCA section 8(a)(7), EPA
believes that the one-time data collection imposed in the 2023 final
rule will aid in collecting all existing and reasonably ascertainable
information related to the manufacturing (including importing) of PFAS
since 2011. As noted in the 2023 final rule, this one-time collection
will help identify data gaps surrounding the knowledge of commercially
manufactured PFAS. Understanding the extent of existing data gaps
related to manufactured PFAS will also help inform and tailor future
EPA actions to address PFAS as needed. The one-time collection will
provide information on the quantity of PFAS to which children may be
exposed. EPA believes that the information obtained as a result of this
one-time data collection could also be used by the public, government
agencies and others to identify potential problems, set priorities, and
take appropriate steps to reduce any potential human health or
environmental risks, including potential risks to children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have any adverse effect on the supply, distribution or use of
energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards under the NTTAA
section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
The EPA believes that this type of action does not concern human
health or environmental conditions and therefore cannot be evaluated
with respect to potentially disproportionate and adverse effects on
communities with environmental justice concerns in accordance with
Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR
25251, April 26, 2023). This action does not materially alter the
reporting requirements under TSCA section 8(a)(7), as discussed in Unit
II.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This does not meet the
criteria set forth in 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 705
Chemicals, Environmental protection, Reporting and recordkeeping
requirements.
Dated: August 29, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons set forth in the preamble, 40 CFR part
705 is amended as follows:
PART 705--REPORTING AND RECORDKEEPING REQUIREMENTS FOR CERTAIN PER-
AND POLYFLUOROALKYL SUBSTANCES
0
1. The authority for part 705 continues to read as follows
Authority: 42 U.S.C. 2607(a)(7).
0
2. Amend Sec. 705.15 by revising paragraph (f)(1) to read as follows:
Sec. 705.15 What information to report.
* * * * *
(f) * * *
(1) Organization for Economic Cooperation and Development (OECD)
Harmonized Templates. For each unpublished study report, the submitter
shall complete an OECD Harmonized Templates for Reporting Chemical Test
Summaries and submit the accompanying study reports and supporting
information. This can be accomplished by using the freely available
IUCLID software.
* * * * *
0
3. Revise Sec. 705.20 to read as follows:
Sec. 705.20 When to report.
All information reported to EPA in response to the requirements of
this part must be submitted during the applicable submission period.
For all reporters submitting information pursuant to Sec. Sec. 705.15
and 705.18(b) (research and development), the submission period shall
begin on July 11, 2025, and last for six months: July 11, 2025, through
January 11, 2026. For any reporter who is reporting under this part
exclusively pursuant to Sec. 705.18(a) (article importers), and is
also considered a small manufacturer under the definition at 40 CFR
704.3, the submission period shall begin on July 11, 2025, and last for
12 months: July 11, 2025, through July 11, 2026.
[FR Doc. 2024-19931 Filed 9-4-24; 8:45 am]
BILLING CODE 6560-50-P