Rule2025-03865
Certain Existing Chemicals; Request To Submit Unpublished Health and Safety Data Under the Toxic Substances Control Act (TSCA); Extension of Submission Deadline
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 13, 2025
Effective
March 13, 2025
Issuing agencies
Environmental Protection Agency
Abstract
In response to requests from stakeholders, 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requires manufacturers (including importers) of 16 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. Specifically, EPA is amending the deadline from March 13, 2025, to June 11, 2025, for one of the 16 chemical substances (vinyl chloride) and to September 9, 2025, for the remaining 15 chemical substances. The Health and Safety Data Reporting Rule requires manufacturers (including importers) of certain chemical substances to submit lists and copies of certain unpublished health and safety studies to EPA.
Full Text
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<title>Federal Register, Volume 90 Issue 48 (Thursday, March 13, 2025)</title>
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[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Rules and Regulations]
[Pages 11899-11903]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-03865]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 716
[EPA-HQ-OPPT-2023-0360; FRL-11164.1-02-OCSPP]
RIN 2070-AL15
Certain Existing Chemicals; Request To Submit Unpublished Health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: In response to requests from stakeholders, 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 report certain lists
and copies of unpublished health and safety studies to EPA.
Specifically, EPA is amending the deadline from March 13, 2025, to June
11, 2025, for one of the 16 chemical substances (vinyl chloride) and to
September 9, 2025, for the remaining 15 chemical substances. The Health
and Safety Data Reporting Rule requires manufacturers (including
importers) of certain chemical substances to submit lists and copies of
certain unpublished health and safety studies to EPA.
[[Page 11900]]
DATES: This rule is effective on March 13, 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#701702191616191e5e0304150018111e1915301500115e171f06"><span class="__cf_email__" data-cfemail="afc8ddc6c9c9c6c181dcdbcadfc7cec1c6caefcadfce81c8c0d9">[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#7521263634583d1a01191c1b10351005145b121a03"><span class="__cf_email__" data-cfemail="b9edeafaf894f1d6cdd5d0d7dcf9dcc9d897ded6cf">[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
(defined by statute to include 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 since they are part of the manufacture of a chemical product
for a commercial purpose.
B. What action is the Agency taking?
EPA promulgated a final rule in the Federal Register of December
13, 2024 (89 FR 100756) (FRL-11164-02-OCSPP)), to require manufacturers
(defined by statute to include importers) of 16 specific chemical
substances to report certain lists and copies of unpublished health and
safety studies to EPA. The 16 chemical substances were added to 40 CFR
716.120 to support ongoing and upcoming activities under TSCA section
6. The Agency is hereby extending the submission deadline established
in that final rule from March 13, 2025, to June 11, 2025, for the
following chemical substance:
<bullet> Vinyl chloride (CASRN 75-01-4).
EPA is extending the deadline established in that final rule from
March 13, 2025, to September 9, 2025, for the following chemical
substances:
<bullet> 4,4-Methylene bis(2-chloraniline) (CASRN 101-14-4);
<bullet> 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol)
(CASRN 140-66-9);
<bullet> Acetaldehyde (CASRN 75-07-0);
<bullet> Acrylonitrile (CASRN 107-13-1);
<bullet> Benzenamine (CASRN 62-53-3);
<bullet> Benzene (CASRN 71-43-2);
<bullet> Bisphenol A (CASRN 80-05-7);
<bullet> Ethylbenzene (CASRN 100-41-4);
<bullet> Hydrogen fluoride (CASRN 7664-39-3);
<bullet> N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD)
(CASRN 793-24-8);
<bullet> 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-
diene-1,4-dione (6PPD-quinone) (CASRN 2754428-18-5);
<bullet> Naphthalene (CASRN 91-20-3);
<bullet> Styrene (CASRN 100-42-5);
<bullet> Tribomomethane (Bromoform) (CASRN 75-25-2); and
<bullet> Triglycidyl isocyanurate (CASRN 2451-62-9).
C. Why is the Agency taking this action?
The Agency is taking this action to provide additional time for the
regulated community to respond to the requirements of the TSCA Health
and Safety Data Reporting rule. Through extension requests submitted to
the EPA, the Agency has recently become aware that a number of
companies are having unanticipated difficulties understanding and
complying with the reporting requirements. EPA wants to ensure that
companies subject to the rule do not face enforcement consequences due
to these unanticipated difficulties, and as discussed further below,
believes that additional time is warranted for EPA to provide guidance
on particular implementation problems raised in the extension requests
that could otherwise frustrate the purpose of the reporting rule.
Additionally, the chemicals included in this final rule are either
in the process of prioritization as candidates for high-priority
designation or are expected to be candidates in the upcoming years.
Collecting health and safety studies on the chemicals included in this
final rule will assist EPA in selecting chemicals to designate as high-
priority chemicals, as well as in conducting the risk evaluation on
such chemicals under TSCA section 6(b). If companies are unable to meet
the requirements of the rule and relevant studies are either not
provided or provided in an unusable form, EPA may be poorly positioned
to conduct prioritization and risk evaluation. Such outcomes complicate
EPA's current ability to make use of any information that it would
receive via this reporting requirement because the Agency will review
information submitted by the deadline and proceed with any TSCA section
6 activities upon processing such information. Incomplete response to
this rule could, in turn, result in the Agency in needing to consider
new information that could impact activities that had been undertaken,
in part, due to the information received by the deadline. Extending the
date helps ensure that such late submissions/revisions do not
complicate activities undertaken subsequent to the deadline.
Of note, this is the first time where a TSCA section 8(d) reporting
rule requires respondents to prepare Organization of Economic
Cooperation and Development (OECD) harmonized templates (OHTs) study
submissions containing confidential business information (CBI), where a
template is available for the study being provided. EPA explained in
the response to comment document for the final rule that it did not
anticipate significant amounts of CBI reporting in response to this
reporting requirement, and thus did not expect that the requirement to
prepare an OHT for a submission containing CBI to would interfere with
timely submissions of data. However, EPA has recently become aware of
unexpected difficulties in complying with the OHT requirement. EPA
received an extension request from a respondent company with
information demonstrating that the company will need to complete
substantially more OHTs than previously estimated based on the
personally identifiable information included in such studies
[[Page 11901]]
(such as a technician's name), which is one of the limited types of
information in health and safety studies that may be asserted as CBI.
EPA believes the company and others similarly situated to be at risk of
non-compliance without additional time. Further, the request leads EPA
to believe that a sizeable proportion of submissions may contain CBI,
contrary to what EPA had anticipated, as there may be more
circumstances where a CBI claim may arise with regard to this data
collection. EPA believes it is appropriate to allow additional time for
respondents to consider whether an OHT is required and then to prepare
any such OHTs.
The timing of these extensions is intended to ensure that the
required data submissions will be timely available for use in risk
evaluations for chemical substances that have been designated as high-
priority substances. Of the 16 chemicals included in this rule, EPA
released 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). Because the draft scope has been available for public comment
since January 16, 2025, EPA expects that companies with such health and
safety studies are more likely to have prioritized working through
those studies to inform relevant comments on the draft scope for risk
evaluation under the original reporting deadline and to inform the
Agency's subsequent development of a draft risk evaluation. Thus, EPA
is extending the submission deadline for vinyl chloride to June 11,
2025, to allow the Agency to take the submissions into account when
preparing a draft TSCA risk evaluation for public comment. For all
other chemical substances, the deadline is extended to September 9,
2025.
In letters seeking an extension to the reporting deadline, copies
of which are included in the docket, EPA received requests for
additional guidance on certain facets of TSCA section 8(d) reporting
generally as well as with regard to the OHT requirement. The benefits
that EPA and the public would receive via this data collection--in the
form of studies that will inform TSCA section 6 activities, among other
uses--will be diminished should EPA not receive information as per the
requirements of the data collection. Accordingly, EPA believes that
additional guidance would be useful to assist companies in complying
with this reporting requirement and plans to provide such guidance
soon. Further, EPA recognizes the uncertainty and potential legal
vulnerability that companies could find themselves in should they not
adhere to the reporting requirements despite their attempts to do so.
Accordingly, additional time to submit the required information will
enable EPA to provide more guidance, as requested, and thereby further
ensure that the Agency receives data as per the goals of the rulemaking
(e.g., to ensure that the Agency has information needed to conduct
prioritization and, as applicable, risk evaluation and risk management
activities involving these chemicals).
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. 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.
The Agency finds that notice and public comment is unnecessary
because the extension of the reporting period does not alter the
substantive existing requirements of the TSCA section 8(d) reporting
rule and it is not expected to interfere with the timely implementation
of EPA's obligations under TSCA section 6. As such, there is no reason
to believe that the public would have an interest in this action and
desire to comment upon it. The Agency believes the extension does not
represent a significant delay in the processing and availability of
information to EPA for TSCA section 6 activities involving these
chemical substances. Receiving TSCA section 8(d) submissions pursuant
to the deadlines provided in this rule will ensure that such
information will be received in time for use in TSCA section 6
activities.
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 original reporting deadline of March 13,
2025. EPA recently became aware of the need for the extension upon
receiving numerous stakeholder requests for extensions and further
guidance regarding unexpected reporting difficulties, as explained
above.
The Agency finds that notice and public comment would be contrary
to the public interest because if notice and comment time frames
prevented the Agency from extending the reporting deadline, currently
March 13, 2025, 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.
This final rule is effective immediately upon publication. Section
553(d)(1) of the Administrative Procedure Act, 5 U.S.C. 553(d)(3),
provides that final rules shall not become effective until 30 days
after publication in the Federal Register, with an exception ``for good
cause found and published with the rule.'' EPA finds that the good
cause discussed above for a final rulemaking without notice and comment
applies equally to having an immediately effective date for this rule,
especially considering the imminent reporting deadline.
II. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory 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 Orders 12866 (58 FR 51735, October 4, 1993)
and 13563 (76 FR 3821, January 21, 2011).
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 2070-0224 (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.
C. 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.).
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million
(in 1995 dollars and adjusted annually for
[[Page 11902]]
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 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.
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 address environmental health or
safety risks disproportionately affecting children. Since this action
does not concern human health, EPA's 2021 Policy on Children's Health
also does not apply.
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. 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. The CRA allows the issuing
agency to make a rule effective sooner than otherwise provided by the
CRA if the agency makes a good cause finding that notice and comment
rulemaking procedures are impracticable, unnecessary or contrary to the
public interest (5 U.S.C. 808(2)). EPA finds that there is good cause
to make this rule immediately effective. (See Unit I.)
List of Subjects in 40 CFR Part 716
Environmental protection, Chemicals, Hazardous substances, Health
and safety, Reporting and recordkeeping requirements.
Nancy 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:
0
a. 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)'',
and ``Triglycidyl isocyanurate''; and
0
b. Removing the entry for ``Vinyl Chloride'' and adding the entry
``Vinyl chloride'' in its place.
The revisions and addition 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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OPPT 2024 Chemicals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaldehyde.......................... 75-07-0 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
Acrylonitrile......................... 107-13-1 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
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................. September 9, 2025.
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................. September 9, 2025.
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................. September 9, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
Bisphenol A........................... 80-05-7 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
Ethylbenzene.......................... 100-41-4 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
[[Page 11903]]
Hydrogen fluoride..................... 7664-39-3 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
4,4-Methylene bis(2-chloraniline)..... 101-14-4 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
N-(1,3-Dimethylbutyl)-N'-phenyl-p- 793-24-8 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
phenylenediamine (6PPD). applies; Sec.
716.20(a)(9) does not
apply.
Naphthalene........................... 91-20-3 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
Styrene............................... 100-42-5 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
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................. September 9, 2025.
Tetramethylbutyl)-phenol). applies; Sec.
716.20(a)(9) does not
apply.
Tribomomethane (Bromoform)............ 75-25-2 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
Triglycidyl isocyanurate.............. 2451-62-9 Sec. 716.21(a)(11) January 13, 2025................. September 9, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
Vinyl chloride........................ 75-01-4 Sec. 716.21(a)(11) January 13, 2025................. June 11, 2025.
applies; Sec.
716.20(a)(9) does not
apply.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
[FR Doc. 2025-03865 Filed 3-12-25; 8:45 am]
BILLING CODE 6560-50-P
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