Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping Under the Toxic Substances Control Act (TSCA); Change to Submission Period
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Abstract
The Environmental Protection Agency (EPA or Agency) is amending the data submission period for the Toxic Substances Control Act (TSCA) PFAS reporting rule by changing the start date for submissions and making corresponding changes to the end dates for the submission period, i.e., the data submission period begins on April 13, 2026, and ends on October 13, 2026, with an alternate end date for small manufacturers reporting exclusively as article importers of April 13, 2027. As promulgated in October 2023, the regulation requires manufacturers (including importers) of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in any year between 2011-2022 to report certain data to EPA related to exposure and environmental and health effects. This change is necessary because EPA requires more time to prepare the reporting application to collect this data. The Agency is separately considering reopening certain aspects of the rule to public comment. The delayed reporting date ensures that EPA has adequate time to consider the public comments and propose and finalize any modifications to the rule before the submission period begins.
Full Text
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<title>Federal Register, Volume 90 Issue 91 (Tuesday, May 13, 2025)</title>
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[Federal Register Volume 90, Number 91 (Tuesday, May 13, 2025)]
[Rules and Regulations]
[Pages 20236-20239]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08168]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 705
[EPA-HQ-OPPT-2020-0549; FRL-7902.2-01-OCSPP]
RIN 2070-AL30
Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data
Reporting and Recordkeeping Under the Toxic Substances Control Act
(TSCA); Change to Submission Period
AGENCY: Environmental Protection Agency (EPA).
ACTION: Interim final rule; request for comment.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
amending the data submission period for the Toxic Substances Control
Act (TSCA) PFAS reporting rule by changing the start date for
submissions and making corresponding changes to the end dates for the
submission period, i.e., the data submission period begins on April 13,
2026, and ends on October 13, 2026, with an alternate end date for
small manufacturers reporting exclusively as article importers of April
13, 2027. As promulgated in October 2023, the regulation requires
manufacturers (including importers) of perfluoroalkyl and
polyfluoroalkyl substances (PFAS) in any year between 2011-2022 to
report certain data to EPA related to exposure and environmental and
health effects. This change is necessary because EPA requires more time
to prepare the reporting application to collect this data. The Agency
is separately considering reopening certain aspects of the rule to
public comment. The delayed reporting date ensures that EPA has
adequate time to consider the public comments and propose and finalize
any modifications to the rule before the submission period begins.
DATES: This interim final rule is effective on May 13, 2025. Comments
must be received on or before June 12, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0549, online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: David Turk, 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: 202-566-1527; email address:
<a href="/cdn-cgi/l/email-protection#057170776e2b6164736c61456075642b626a73"><span class="__cf_email__" data-cfemail="4e3a3b3c25602a2f38272a0e2b3e2f60292138">[email protected]</span></a>.
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: <a href="/cdn-cgi/l/email-protection#adf9feeeec80e5c2d9c1c4c3c8edc8ddcc83cac2db"><span class="__cf_email__" data-cfemail="32666171731f7a5d465e5b5c57725742531c555d44">[email protected]</span></a>.
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:
<bullet> Construction (NAICS code 23);
<bullet> Manufacturing (NAICS codes 31 through 33);
<bullet> Wholesale trade (NAICS code 42);
<bullet> Retail trade (NAICS codes 44 through 45); and
<bullet> 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.
B. What action is the Agency taking?
EPA is amending the data submission period for the TSCA section
8(a)(7) PFAS reporting rule codified in 40 CFR part 705 by changing the
start date to April 13, 2026, and making corresponding changes to the
end dates for the submission period. As modified by this rule, the data
submission period begins on April 13, 2026, and ends on October 13,
2026, with an alternate end date for small manufacturers reporting
exclusively as article importers of April 13, 2027. The Agency is
taking 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). Further, the Agency may, in a future separate action,
reopen other aspects of this rule for public comment in light of
Executive Order 14219: Unleashing Prosperity through Deregulations (90
FR 9065, January 31, 2025). In this action, however, EPA is not
reopening or reconsidering any provisions of the underlying reporting
rule other than the submission period dates.
[[Page 20237]]
Although EPA continues to devote significant resources to the
development of the reporting application, EPA will not be in a position
to verify that the data will be submitted and stored in a usable manner
on the current start date of July 11, 2025. At this point in the
project development timeline, EPA does not have time to conduct
industry beta testing of the application and incorporate any tester
feedback prior to the start of the submission period. Without a period
of industry beta testing as previously planned, the current reporting
timeline is no longer tenable, and maintaining that timeline would
require entities to submit data before EPA has sufficiently verified
that the technological capacity is 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.
Though EPA notes that it may reopen portions of the rule to comment
regarding potential modifications, this action does not alter any
aspect of the TSCA section 8(a)(7) PFAS rule in 40 CFR part 705 except
for the data submission period dates. Accordingly, comments regarding
topics other than the commencement of the reporting period are outside
the scope of this action. This action provides additional time for the
Agency's reporting application to be completed and sufficiently tested
to ensure that reporting entities do not experience technical issues
that prevent or complicate successful 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 and test the application while reporting is
occurring, which could negatively impact submissions in progress or
other functions of the reporting application.
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 Agency is able to establish the
full data collection infrastructure 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.
Any impact on the regulated community is expected to be beneficial
given that the extension provides additional time to submit reports to
EPA and minimize potential for technical issues.
C. 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)) and September 5,
2024 (89 FR 72336 (FRL-7902.1-02-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
perfluoroalkyl or polyfluoroalkyl substance 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.
In addition, under section 553(b)(B) of the Administrative
Procedure Act (APA) (5 U.S.C. 553(b)(B)), ``an agency may issue a final
rule without providing notice and an opportunity for public comment if
it for good cause finds that notice and public procedures are
impracticable, unnecessary, or contrary to the public interest.''
D. Why is the Agency using an interim final rule?
EPA finds that notice and public comment is impracticable because
there is insufficient time for notice and comment on an extension to
the deadline prior to the reporting deadline of July 11, 2025. EPA
recently became aware of the need for the extension after EPA was
unable to conduct industry beta testing of the Central Data Exchange
(CDX) application as originally planned. Moving the start of the
submission period will provide more time for EPA to conduct necessary
beta testing of the reporting application, which the Agency was unable
to do as previously scheduled. This beta testing period will provide
critical feedback to the Agency on the application and database
infrastructure, including on any appropriate guidance that can be
provided to the reporting community. Further, Congress recently
appropriated additional funds to EPA in the FY2025 Continuing
Resolution for the purposes of improving EPA's information technology
infrastructure for the TSCA program. With additional time to receive
and distribute those funds provided by the nine-month extension in this
rule, EPA may be able to improve functionality of the reporting
application and databases.
The Agency finds that notice and public comment would be contrary
to the public interest. If notice and comment time frames prevent the
Agency from delaying the start of the reporting deadline prior to July
11, 2025, submitters would be confronted with using a CDX application
that has not yet undergone rigorous beta testing. Thus, any data
submissions might be provided without sufficient resources to ensure
secure certification and accuracy and ultimately impair the ability of
the Agency to carry out its obligations under TSCA and enable public
access to the information, as appropriate. It is in the interest of
both the public and industry to delay the start of the reporting period
April 13, 2026, to allow EPA time necessary to confirm that the
infrastructure underlying the data collection process is working
optimally.
In conclusion, for the reasons enumerated above, EPA is
promulgating this interim final rule without a general notice of
proposed rulemaking pursuant to 5 U.S.C. 553(b)(3)(B) because the
Agency finds good cause that notice and public comment procedures are
impracticable and contrary to the public interest. In addition, EPA
also intends to issue a separate notice of proposed rulemaking in the
near future that will, among other things, allow for further comment on
the appropriate reporting period. EPA intends to address comments in
response to this final rule and the notice of proposed rulemaking
concurrently and to publish a final rule.
This final rule is effective immediately upon publication. Section
553(d)(1) of the Administrative Procedure Act, (5 U.S.C. 553(d)(1)),
provides that final rules shall not become effective until 30 days
after publication in the Federal Register, with an exception for ``a
substantive rule which grants or recognizes an exemption or relieves a
restriction.'' This rule relieves a restriction by extending the
reporting deadline by nine months. This extension also provides the
Agency an opportunity to reconsider and, if applicable, propose a
separate action to modify any aspects of the TSCA section 8(a)(7)
reporting rule through standard notice and comment rulemaking
procedures.
[[Page 20238]]
II. Background
A. What is the modification to the submission period?
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 and fulfills 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.
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 promulgate a final rule that
published on October 11, 2023 (88 FR 70516 (FRL-7902-02-OCSPP)). The
information required to be collected under TSCA section 8(a)(7) is
critical to advancing the Agency's understanding of PFAS in commerce
and will create a database of information on previously manufactured
PFAS in commerce to support EPA's actions to address PFAS exposure and
contamination.
Resource constraints, alongside additional priorities, impacted 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. As explained in a September 5, 2024,
Federal Register notice, resource constraints forced the agency to move
the reporting period once (89 FR 72336, September 5, 2024) (FRL-7902.1-
02-OCSPP)), delaying the commencement of the reporting period from
November 12, 2024, to July 11, 2025. The Agency previously extended the
reporting period (89 FR 72336 (September 5, 2024) (FRL-7902.1-02-
OCSPP)) due to resource and funding constraints for the CDX application
support.
Similarly, as explained in this notice, the Agency must again delay
the data submission period because of EPA must extend the time provided
for project development and testing. As modified by this rule, the data
submission period begins on April 13, 2026, and ends on October 13,
2026, with an alternate end date of April 13, 2027, for small
manufacturers reporting exclusively as article importers. As codified,
this includes a start and end date for submissions, including an
alternate end date for small entities.
B. Why is the Agency modifying the data submission period?
EPA has considered the costs of compliance with the reporting
requirements using a potentially inadequate IT system against the costs
to the public associated with a reporting delay. EPA has determined
that the costs of compliance with an under-tested IT system outweigh
the costs to the public associated with a delay in reported data, as
EPA would not be able to provide public access of such data in the face
of uncertainty over its integrity.
EPA typically conducts testing prior to making a new reporting
application available. Recognizing that users have been having
difficulties with other TSCA reporting applications (e.g., the
application for Chemical Data Reporting (CDR)), the Agency believes it
is critical to ensure that the TSCA section 8(a)(7) PFAS reporting
application is adequately tested before reporting under this rule
begins. 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. The current timelines for the
submission of data under the rule would not allow this testing to be
completed before the reporting period commences.
To ensure functioning reporting capability, EPA must extend the
time provided for project development and testing. The reporting tool
will be available beginning April 13, 2026. EPA is not altering the
length of time provided for reporters to submit data. Delaying the
commencement of the reporting period to April 13, 2026, will ensure
that the project team has adequate time to complete development and
testing of the reporting tool, along with incorporation of any findings
from testing participants. Thus, EPA is delaying the commencement of
the reporting period to that date. Reporters will still have the same
amount of time to submit data as was provided in the original rule (see
40 CFR part 705). EPA is not amending any other aspects of the
regulation at this time.
III. Statutory and Executive Orders Reviews
Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/laws-regulations-and-executive-orders">https://www.epa.gov/laws-regulations-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review
This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review under Executive Order 12866 (58 FR 51735, October 4, 1993).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
This action is considered an Executive Order 14192 deregulatory
action. This interim final rule provides burden reduction by relieving
immediate pressure on manufacturers for rule familiarization, data
collection and preparation, and electronic reporting. This longer
timeframe will also reduce the opportunity costs on affected firms.
C. Paperwork Reduction Act (PRA)
This action does not contain an 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.
D. Regulatory Flexibility Act (RFA)
This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA
applies only to rules subject to notice and comment rulemaking
requirements under the APA, 5 U.S.C. 553, or any other statute. This
rule is not subject to notice and comment requirements under the APA
because the Agency has invoked the APA ``good cause'' exemption (see
Unit I.).
E. 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.
F. 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
[[Page 20239]]
responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship 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.
H. 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.
I. 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.
J. 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.
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 action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 705
Chemicals, Environmental protection, Reporting and recordkeeping
requirements.
Dated: May 5, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and
Pollution Prevention.
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. Revise Sec. 705.20 to read as follows:
Sec. 705.20 When to report.
(a) 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 April 13, 2026, and last for six months: April 13, 2026,
through October 13, 2026.
(b) 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 April 13, 2026, and last for 12
months: April 13, 2026, through April 13, 2027.
[FR Doc. 2025-08168 Filed 5-12-25; 8:45 am]
BILLING CODE 6560-50-P
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