Rule2025-10410
Certain Existing Chemicals; Request To Submit Unpublished Health and Safety Data Under the Toxic Substances Control Act (TSCA); Extension of Submission Deadline
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Published
June 9, 2025
Effective
June 9, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is amending the deadline for reporting pursuant to the Toxic Substances Control Act (TSCA) Health and Safety Data Reporting rule, which requires manufacturers (including importers) of 16 specified chemical substances to submit lists and copies of certain unpublished health and safety studies to the EPA. Specifically, the EPA is amending the reporting deadline for all 16 chemical substances subject to the rule to May 22, 2026, through final action.
Full Text
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<title>Federal Register, Volume 90 Issue 109 (Monday, June 9, 2025)</title>
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[Federal Register Volume 90, Number 109 (Monday, June 9, 2025)]
[Rules and Regulations]
[Pages 24228-24231]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10410]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 716
[EPA-HQ-OPPT-2023-0360; FRL-11164.2-02-OCSPP]
RIN 2070-AL31
Certain Existing Chemicals; Request To Submit Unpublished Health
and Safety Data Under the Toxic Substances Control Act (TSCA);
Extension of Submission Deadline
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
amending the deadline for reporting pursuant to the Toxic Substances
Control Act (TSCA) Health and Safety Data Reporting rule, which
requires manufacturers (including importers) of 16 specified chemical
substances to submit lists and copies of certain unpublished health and
safety studies to the EPA. Specifically, the EPA is amending the
reporting deadline for all 16 chemical substances subject to the rule
to May 22, 2026, through final action.
DATES: This rule is effective on June 9, 2025.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2023-0360, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#5c3b2e353a3a3532722f28392c343d3235391c392c3d723b332a"><span class="__cf_email__" data-cfemail="305742595656595e1e4344554058515e5955705540511e575f46">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#b6e2e5f5f79bfed9c2dadfd8d3f6d3c6d798d1d9c0"><span class="__cf_email__" data-cfemail="10444353513d587f647c797e75507560713e777f66">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import) any of the chemical substances that are listed in 40
CFR 716.120(d) of the regulatory text of this document. The following
list of North American Industrial Classification System (NAICS) codes
affected by this rule are those that align with these activities:
<bullet> Chemical manufacturers (including importers), (NAICS code
325); and
<bullet> Petroleum refineries (NAICS code 324110).
This action applies to manufacturers in these NAICS codes who are
currently manufacturing (including importing) a listed chemical
substance (or will do so during the chemical's reporting period) or who
have manufactured (including imported) or proposed to manufacture
(including import) a listed chemical substance within the last 10
years.
This action may also affect manufacturers of substances for
commercial purposes that coincidentally produce the substance during
the manufacture, processing, use, or disposal of another substance or
mixture, including byproducts and impurities. Such byproducts and
impurities may, or may not, in themselves have commercial value. They
are nonetheless produced for the purpose of obtaining a commercial
advantage because they are part of the manufacture of a chemical
product for a commercial purpose.
B. What action is the Agency taking?
The EPA is amending the data submission period for the TSCA section
8(d) rule by changing the reporting deadline for all 16 chemical
substances to May 22, 2026.
C. Why is the Agency taking this action?
The EPA promulgated a final rule in the Federal Register of
December 13, 2024 (89 FR 100756 (FRL-11164-02-OCSPP)), to require
manufacturers (including importers) of 16 specific chemical substances
to submit copies and lists of certain unpublished health and safety
studies to the EPA. The 16 chemical substances were added to 40 CFR
716.120 to support ongoing and upcoming activities under TSCA section
6. On March 13, 2025, the EPA modified the submission deadlines from
March
[[Page 24229]]
13, 2025, to June 11, 2025, for vinyl chloride (CASRN 75-01-4) and from
March 13, 2025, to September 9, 2025, for the remaining 15 chemical
substances (90 FR 11899 (FRL-11164.1-02-OCSPP)). The EPA now recognizes
a need to further extend these reporting deadlines as explained below.
The Agency is taking this action for several reasons. First, the
EPA needs additional time to provide guidance on particular
implementation problems that entities subject to the rule have raised
to the Agency as described in the EPA's previous March 13, 2025, final
rule to modify the reporting deadlines for the chemical substances
subject to this rule. Despite best efforts to act expeditiously, the
Agency has not yet finalized this guidance, which will address topics
such as submitting harmonized templates, which are required for
submissions containing Confidential Business Information. In this
action, however, the EPA is not reopening or reconsidering provisions
of the underlying rule other than the submission deadline.
When the EPA previously extended the reporting deadlines for the 16
chemical substances subject to this rule, the Agency bifurcated the
deadlines such that the modified deadline for vinyl chloride was June
11, 2025, and the modified deadline for the remaining 15 chemical
substances was September 9, 2025 (90 FR 11899, March 13, 2025 (11164.1-
02-OCSPP)). In the final rule to modify these deadlines, the EPA
explained that it anticipated that companies were more likely to have
already reviewed their records for studies of vinyl chloride, as
compared with the other chemical substances subject to this rule,
because the Agency published a draft scope for the TSCA risk evaluation
of vinyl chloride for public comment on January 16, 2025 (90 FR 4738
(FRL-12439-01-OCSPP)). Accordingly, the EPA expected that companies
with unpublished health and safety studies on vinyl chloride would
likely have prioritized this chemical substance in terms of searching
for records to support commenting on the draft scope.
However, the EPA has been unable as yet to resolve the issues for
which additional guidance is needed and continues to have substantial
concerns that the scope of the reporting required will be difficult for
companies to provide. As such, the EPA believes that providing a later
reporting deadline for vinyl chloride, as well as for the other
chemical substances subject to this rule, will ensure consistency of
reporting requirements for all 16 chemical substances subject to this
rule as well as provide the EPA sufficient time to incorporate data
received in response to this rule for any of the Agency's associated
TSCA section 6 responsibilities. Thus, the EPA finds it prudent to
delay the deadline for the reporting requirements subject to this rule
for all 16 chemical substances.
D. What is the Agency's authority for taking this action?
The Health and Safety Data Reporting rule for these 16 chemical
substances is promulgated under TSCA section 8(d) (15 U.S.C. 2607(d))
and codified at 40 CFR part 716. The EPA's statutory authority to
modify the deadlines for the final TSCA section 8(d) rule is the same
statutory authority relied upon to promulgate the underlying rule. The
EPA's authority for the rulemaking procedures used in this direct final
rule is Administrative Procedure Act (APA) section 553(b)(B), 5 U.S.C.
553(b)(B), which permits an agency to forego notice and an opportunity
for public comment if the agency finds good cause that such procedures
are impracticable, unnecessary, or contrary to the public interest.
The EPA finds that notice and public comment is impracticable here
because there is insufficient time for notice and comment on an
extension to the deadline prior to the reporting deadline for vinyl
chloride of June 11, 2025. Though more time is available ahead of the
September 9, 2025 deadline for the other 15 chemical substances, it is
nonetheless a limited period in which to conduct a notice and comment
rulemaking. Relatedly, notice and public comment would be contrary to
the public interest because if notice and comment timeframes prevented
the Agency from extending the reporting deadline, many TSCA section
8(d) submissions might be provided without sufficient time or guidance
to properly prepare them, impairing the ability of the Agency to carry
out its prioritization and risk evaluation requirements and defeating
the purpose of the rule, which is to effectuate the public interest by
providing the EPA with sound data to analyze risk and protect human
health and the environment. The EPA further notes that extending the
submission period avoids the risk of covered entities collecting
irresponsive materials that may not be required or may be required in a
different format once the Agency issues related guidance on issues such
as the use of harmonized templates.
This final rule is effective immediately upon publication. APA
section 553(d)(1), 5 U.S.C. 553(d)(3), provides that agencies may make
a final rule effective immediately ``for good cause found and published
with the rule.'' The EPA finds that the good cause discussed above
applies equally to having an immediately effective date for this rule,
especially considering the imminent reporting deadline for vinyl
chloride. The EPA notes that the volume of reporting required means
that covered entities require significant lead time prior to the
compliance date to collect, process, and format the necessary
information, meaning that an immediate effective date is appropriate
for the 15 additional chemical substances as well.
II. Statutory and Executive Order 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 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 opportunity costs on affected firms.
C. 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 previously approved the
information collection activities contained in the existing regulations
and assigned OMB control number 2070-0224 (EPA ICR No. 2701.01). 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
[[Page 24230]]
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 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.
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 address environmental health or
safety risks disproportionately affecting children. Because this action
does not concern human health, EPA's 2021 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 716
Environmental protection, Chemicals, Hazardous substances, Health
and safety, Reporting and recordkeeping requirements.
Dated: June 4, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and
Pollution Prevention.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 716--HEALTH AND SAFETY DATA REPORTING
0
1. The authority citation for part 716 continues to read as follows:
Authority: 15 U.S.C. 2607(d).
0
2. Amend Sec. 716.120 in table 3 to paragraph (d), under the heading
``OPPT 2024 Chemicals'', by revising the entries for ``Acetaldehyde'',
``Acrylonitrile'', ``2-anilino-5-[(4-methylpentan-2-yl)amino]cyclohexa-
2,5-diene-1,4-dione (6PPD-quinone)'', ``Benzenamine'', ``Benzene'',
``Bisphenol A'', ``Ethylbenzene'', ``Hydrogen fluoride'', ``4,4-
Methylene bis(2-chloraniline)'', ``N-(1,3-Dimethylbutyl)-N'-phenyl-p-
phenylenediamine (6PPD)'', ``Naphthalene'', ``Styrene'', ``4-tert-
octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol)'', ``Tribomomethane
(Bromoform)'', ``Triglycidyl isocyanurate'', and ``Vinyl chloride'' to
read as follows:
Sec. 716.120 Substances and listed mixtures to which this subpart
applies.
* * * * *
(d) * * *
Table 3 to Paragraph (d)
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Category CASRN Special exemptions Effective date Sunset date
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* * * * * * *
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OPPT 2024 Chemicals:
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Acetaldehyde......................... 75-07-0 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
Acrylonitrile........................ 107-13-1 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
2-anilino-5-[(4-methylpentan-2- 2754428-18-5 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
yl)amino]cyclohexa-2,5-diene-1,4- applies; Sec.
dione (6PPD-quinone). 716.20(a)(9) does not
apply.
Benzenamine.......................... 62-53-3 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply applies; Sec.
716.20(a)(9) does not
apply.
Benzene.............................. 71-43-2 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
Bisphenol A.......................... 80-05-7 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
Ethylbenzene......................... 100-41-4 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
Hydrogen fluoride.................... 7664-39-3 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec. Sec.
716.20, 716.20(a)(9)
does not apply.
4,4-Methylene bis(2-chloraniline).... 101-14-4 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec. 716.20,
716.20(a)(9) does not
apply.
[[Page 24231]]
N-(1,3-Dimethylbutyl)-N'-phenyl-p- 793-24-8 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
phenylenediamine (6PPD). applies; Sec.
716.20(a)(9) does not
apply.
Naphthalene.......................... 91-20-3 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
Styrene.............................. 100-42-5 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
4-tert-octylphenol(4-(1,1,3,3- 140-66-9 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
Tetramethylbutyl)-phenol). applies; Sec. 716.20,
716.20(a)(9) does not
apply.
Tribomomethane (Bromoform)........... 75-25-2 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
Triglycidyl isocyanurate............. 2451-62-9 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
Vinyl chloride....................... 75-01-4 Sec. 716.21(a)(11) January 13, 2025.................. May 22, 2026.
applies; Sec.
716.20(a)(9) does not
apply.
* * * * * * *
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[FR Doc. 2025-10410 Filed 6-6-25; 8:45 am]
BILLING CODE 6560-50-P
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