Certain Existing Chemicals; Request To Submit Unpublished Health and Safety Data Under the Toxic Substances Control Act (TSCA), 20918-20924 [2024-06303]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Proposed Rules]
[Pages 20918-20924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06303]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 716

[EPA-HQ-OPPT-2023-0360; FRL-11164-01-OCSPP]
RIN 2070-AL15


Certain Existing Chemicals; Request To Submit Unpublished Health 
and Safety Data Under the Toxic Substances Control Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is 
proposing to require manufacturers (including importers) of 16 chemical 
substances to submit copies and lists of certain unpublished health and 
safety studies to EPA. Health and safety studies sought by this action 
will help inform EPA's responsibilities pursuant to TSCA, including 
prioritization, risk evaluation, and risk management.

DATES: Comments must be received on or before May 28, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2023-0360, through 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 or visiting the 
docket, along with more information about dockets generally, is 
available at https://www.epa.gov/.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Lameka Smith, Data Gathering and 
Analysis Division (7406M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-1629; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(including import) chemical substances and mixtures. 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:
     Chemical manufacturing (NAICS code 325);
     Petroleum refineries (NAICS code 324110); and
     Tire manufacturing (NAICS code 32621).
    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 is proposing to require manufacturers of chemical substances 
listed in this document to submit copies and lists of certain 
unpublished health and safety studies to EPA. This proposed rule is 
intended to provide EPA with useful information for prioritization, 
risk evaluations, and risk management under TSCA section 6 regarding 
the chemical substances discussed below. This action lists the chemical 
substances and their Chemical Abstracts Service Registry Numbers 
(CASRNs) that would be added to 40 CFR 716. It also lists proposed 
specific data reporting requirements.

C. What is the Agency's authority for taking this action?

    EPA promulgated the Health and Safety Data Reporting Rule that is 
codified at 40 CFR part 716 under TSCA section 8(d) (15 U.S.C. 
2607(d)). EPA is proposing this rule under its authority in TSCA 
section 8(d) to require the submission of health and safety studies, 
and lists of studies, regarding certain chemical substances.

D. What are the estimated incremental impacts of this action?

    EPA prepared an economic analysis of the impacts associated with 
the proposed addition of the 16 chemical substances to the TSCA section 
8(d) Health and Safety Data Reporting rule, titled, ``TSCA Section 
8(d): Economic Impact Analysis for Adding 16 Chemicals to the Health 
and Safety Data Reporting Rule'' (Ref. 1). This economic analysis is 
available in the docket and is summarized here.
    EPA estimates that the costs of this action will be approximately 
$301,956 in the first year of reporting, with 3,388 estimated paperwork 
burden hours. In addition, EPA has determined that, of the 44 small 
businesses affected by this action, 1 is estimated to incur a maximum 
annualized cost impact of more than 1% of revenues. Thus, this action 
is not expected to have a significant adverse economic impact on a 
substantial number of small entities as further discussed in Unit IV.C.

E. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your 
comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the 
part or all of the information that you claim to be CBI. In addition to 
one complete version of the

[[Page 20919]]

comment that includes information claimed as CBI, a copy of the comment 
that does not contain the information claimed as CBI must be submitted 
for inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2 and/or 40 CFR part 703, as applicable.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.html.

II. Background

A. What chemical substances is EPA proposing to add?

    EPA is proposing the addition of 16 chemical substances to amend 
the list at 40 CFR 716.120. This list contains chemical substances for 
which the health and safety study data reporting is required. For this 
proposed rule, the 16 chemical substances will amend the current list 
and be added at 40 CFR 716.21(a)(11). If any special exemptions are 
required for a specific chemical substance, it will be identified in 
the table below under special exemptions. Special exemptions are 
reporting requirements that are specific to a chemical substance and 
would include specific language about specific studies and 
requirements. The chemical substances being added by this proposed rule 
are listed below:
     4,4-Methylene bis(2-chloraniline) (CASRN 101-14-4);
     4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) 
(CASRN140-66-9);
     Acetaldehyde (CASRN75-07-0);
     Acrylonitrile (CASRN 107-13-1);
     Benzenamine (CASRN 62-53-3);
     Benzene (CASRN 71-43-2);
     Bisphenol A (CASRN 80-05-7);
     Ethylbenzene (CASRN 100-41-4);
     Naphthalene (CASRN 91-20-3);
     Vinyl Chloride (CASRN 75-01-4);
     Styrene (CASRN 100-42-5);
     Tribomomethane (Bromoform) (CASRN 75-25-2);
     Triglycidyl isocyanurate; (CASRN 2451-62-9);
     Hydrogen fluoride (CARN 7664-39-3);
     N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD) 
(CASRN 793-24-8); and
     2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-
diene-1,4-dione (6PPD-quinone) (CASRN 2754428-18-5).

B. What are the proposed reporting requirements?

    The proposed reporting requirements for the 16 chemical substances 
listed in Unit II.A. include the following, with the specific types of 
health and safety studies listed in Unit II.D.:
     Manufacturers who, in the 10 years preceding the date a 
chemical substance is listed, either have proposed to manufacture or 
have manufactured any of the listed chemical substances must submit to 
EPA, during the 60-day reporting period specified in 40 CFR 716.65 and 
according to the reporting schedule set forth at 40 CFR 716.60, would 
be required to submit a copy of each specified type of health and 
safety study which is in their possession at the time the chemical 
substance is listed in 40 CFR part 716.
     Manufacturers who, either at the time of or after the 
chemical substance is listed in part 716, propose to manufacture or are 
manufacturing the listed chemical substance would be required to submit 
to EPA during the 60-day reporting period specified in 40 CFR 716.65 
and according to the reporting schedule set forth at 40 CFR 716.60:

--A copy of each specified type of health and safety study which is in 
their possession at the time the chemical substance is listed;
--A list of the specified types of health and safety studies known to 
them but not in their possession at the time the chemical substance is 
listed;
--A list of the specified types of health and safety studies that are 
ongoing at the time the chemical substance is listed and are being 
conducted by or for them;
--A list of the specified types of health and safety studies that are 
initiated after the date the chemical substance is listed and will be 
conducted by or for them; and
--A copy of each specified type of health and safety study that was 
previously listed as ongoing or subsequently initiated (i.e., listed in 
accordance with reporting requirements in Unit II.D., respectively) and 
is now complete regardless of completion date.

    The proposed reporting would be required 90 days after date the 
final rule is issued from those who manufacture or proposes to 
manufacture the listed chemical substance from [to be determined 30 
days after date of publication of the final rule] to [to be determined 
as 90 days after date of publication of the final rule] must inform EPA 
(by submitting a list) of any studies initiated during the period from 
[to be determined as 30 days after date of publication of the final 
rule] to [to be determined as 90 days after date of publication of the 
final rule] within 30 days of their initiation, but in no case later 
than [to be determined as 120 days after date of publication of the 
final rule].
    The proposed reporting described in Unit II.D. would be required 90 
days after the final rule is issued from those who manufactures or 
proposes to manufacture the listed chemical substance from [to be 
determined as 30 days after date of publication of the final rule] to 
[to be determined as 90 days after date of publication of the final 
rule] must inform EPA (by submitting a list) of any studies initiated 
during the period from [to be determined as 30 days after date of 
publication of the final rule] to [to be determined as 90 days after 
date of publication of the final rule] within 30 days of their 
initiation, but in no case later than [to be determined as 120 days 
after date of publication of the final rule].
    In addition, if any such person has submitted lists of studies that 
were ongoing or initiated during the period from [to be determined as 
30 days after date of publication of the final rule] to [to be 
determined as 90 days after date of publication of the final rule] to 
EPA, such person must submit a copy of each study within 30 days after 
its completion, regardless of the study's completion date. See 40 CFR 
716.60 and 716.65.

C. What are the exemptions under this proposed rule?

    Detailed guidance for reporting unpublished health and safety data 
is provided at 40 CFR part 716. Also found at 40 CFR 716.20 are 
explanations of reporting exemptions. EPA is proposing that the 
exemption listed at 40 CFR 716.20(a)(9), for persons manufacturing a 
substance only as an impurity, would not be available for the 
substances subject to this proposed rule. An impurity is defined as a 
chemical substance that is unintentionally present with another 
chemical substance. Impurities are not manufactured for distribution in 
commerce as chemical substances and have no commercial purpose separate 
from the chemical substance or mixture of which they are a part. 
Rulemaking proceedings that add chemical substances and mixtures to 40 
CFR 716.120 will specify the types of health and safety studies that 
must be reported and will specify chemical grade/purity that must be 
met or exceeded in individual studies. Pursuant to the rulemaking 
procedure that requires EPA to identify the chemical/grade purity, EPA 
is requiring reporting on any purity level of the chemical.

[[Page 20920]]

    EPA is proposing to require submissions of health and safety 
studies from companies manufacturing the identified chemical 
substances, including when a company is importing the chemical 
substance as a pure substance, mixture, formulated product, or article 
contains the subject chemical substance. Reporting would be required 
where the chemical substance is included as an impurity. EPA considers 
conditions of use associated with circumstances where a chemical 
substance subject to a risk evaluation even where the chemical 
substance is an impurity. To such ends, health and safety information 
associated with the conditions of use, whether as a pure chemical, part 
of a mixture or article, or as an impurity helps inform such risk 
evaluation. Accordingly, the chemicals included in today's action are 
of particular interest to EPA because they are either in the process of 
prioritization as candidates for high-priority designation or are 
expected to be candidates in the upcoming years. For those found to be 
of high priority, EPA is required to immediately conduct a risk 
evaluation. Collecting health and safety studies on the chemicals 
identified by this proposal will assist EPA in selecting chemicals to 
designate as high-priority chemicals as well as conduct risk evaluation 
on such designated chemicals.

D. What types of studies must be submitted?

    Pursuant to 40 CFR 716.10 and 716.50, manufacturers are required to 
submit the following types of information:
     Lists and copies of unpublished health and safety studies 
for all substances specified in this rule on health effects, such as 
toxicity studies (e.g., in vivo, in vitro) on carcinogenicity, 
reproductive and developmental effects, genotoxicity, neurotoxicity, 
immunotoxicity, endocrine effects, and other systemic toxicity and 
toxicokinetic (absorption, distribution, metabolism, or elimination), 
including modeling studies, in humans or animals.
     All unpublished studies on environmental effects and 
physical-chemical properties if performed as described in 40 CFR 
716.50.
     All unpublished studies on occupational, general 
population, consumer, and environmental exposure, such as: unpublished 
studies on inhalation and dermal exposure, human biomonitoring, 
environmental monitoring of indoor and outdoor air, soil, water, and 
household dust, chamber emission rates from products or polymeric 
matrices, and unpublished modeling studies that estimate environmental 
concentrations or human exposures.
     Studies showing any measurable content of the tested 
substance (single substance or mixture). The composition and purity of 
test substances must be reported if included as part of the study.
     Studies previously submitted to EPA pursuant to a 
requirement under TSCA or of the submitter's own accord and studies 
conducted or to be conducted pursuant to a TSCA section 4 action are 
exempt from the submission of lists of health and safety studies 
required under 40 CFR 716.35 and the submission of studies required 
under this rule.
     Surveys, tests, and studies of biological, photochemical, 
and chemical degradation. Chemical identities are part of the submitted 
health and safety studies or data and must be submitted to EPA. 
Information from health and safety studies and/or data is not protected 
from disclosure, except to the extent such studies or information 
reveal information ``that discloses processes used in the manufacturing 
or processing of a chemical substance. Or, in the case of a mixture, 
the portion of the mixture comprised by any of the chemical substances 
in the mixture,'' 15 U.S.C. 2613(2)(B). Additional information, listed 
in the rule's definition of health and safety study, are not part of a 
health and safety study (e.g., names of laboratory personnel). 
Submitters asserting a CBI claim for information are required to submit 
a sanitized copy, removing only the information that is claimed as CBI.

E. How to report?

    All submitters would be required to report TSCA section 8(d) data 
electronically, using the CSPP: Submissions for Chemical Safety and 
Pesticide Programs software (CSPP Software) accessible via EPA's 
Central Data Exchange (CDX) system available at https://cdx.epa.gov/. 
The CSPP Software provides a TSCA 8(d) Health and Safety Data Reporting 
application that a registered CDX user will access to submit TSCA 
section 8(d) records. Information on how to submit TSCA section 8(d) 
data is available in the docket (EPA-HQ-OPPT-2023-0360) and via EPA's 
TSCA section 8(d) web page for this action at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/section-8d-health-safety-data-reporting-user-guide-0. Submitters may also contact EPA's TSCA 
Hotline at [email protected] or 202-554-1404. For help with 
accessing your CDX account, please contact the CDX help desk at https://cdx.epa.gov/contact or (888) 890-1995 (for international callers: 
(970) 494-5500).
    1. Submitting confidential business information. Any person 
submitting copies of records may assert a business confidentiality 
claim covering all or part of the submitted information in accordance 
with the procedures described in 40 CFR part 703 (88 FR 37155, June 7, 
2023 (FRL-8223-02-OCSPP)). Requirements for asserting and maintaining 
confidentiality claims are described in 40 CFR 703.5. Such claim must 
be made concurrent with submission of the information. If no such claim 
accompanies the submission, EPA will not recognize a confidentiality 
claim, and the information in that submission may be made available to 
the public without further notice. Confidentiality claims must be 
substantiated at the time of submission to EPA pursuant to the 
requirements of 40 CFR 703.5(b). To assert a claim of confidentiality 
for information contained in a submitted record, the respondent must 
submit two copies of the document. One copy must be complete. In that 
copy, the respondent must indicate what information, if any, is claimed 
as confidential by marking the specific information on each page with a 
label such as ``confidential'', ``proprietary'', or ``CBI.'' The other 
copy must be a public version of the submission and attachments, with 
all information that is claimed as confidential removed (40 CFR 
703.5(c)). Both the copy containing information claimed as CBI and the 
``sanitized'' copy must be submitted electronically. The TSCA section 
8(d) Health and Safety Data Reporting application incorporates many of 
the requirements for asserting CBI claims, including substantiation 
questions, a required certification statement, and prompts to provide a 
sanitized copy. Further details regarding the requirements for 
confidentiality claims can be found in 40 CFR part 703.
    2. Submitting harmonized templates. Additionally, EPA finalized the 
requirement for submitting all existing information concerning health 
and environmental effects in the format of Organization of Economic 
Cooperation and Development's (OECD) harmonized templates, where such 
templates exist for the type of data (codified at 40 CFR 705.15(f)). 
OECD templates are accessible to the public online at https://oecd.org/ehs/templates/harmonised-templates.htm. This can be accomplished by 
using the freely available IUCLID6 software by exporting the dossier in 
the OECD Harmonized

[[Page 20921]]

Template working context. EPA can accept any dossiers generated using 
any version of IUCLID6 available at https://www.epa.gov/tsca-cbi/final-rule-requirements-confidential-business-information-claims-under-tsca#Implementation. EPA believes that some of the data will already be 
available as an OECD template if the company had already submitted the 
studies under the European Union's Registration, Evaluation, 
Authorization and Restriction of Chemicals (REACH) regulation. In 
addition to the required template format, those subject to this 
rulemaking must submit any associated full study reports or underlying 
data as support documents. The full study reports and support documents 
are necessary for EPA to understand the full context and evaluate the 
quality of the data, which is necessary for the Agency to review to 
determine whether such data may be used for any future Agency actions. 
If an OECD-harmonized template is not available for a particular 
endpoint for which the manufacturer has relevant information, then the 
manufacturer must still submit the data. Such information may include, 
but is not limited to, raw monitoring data (regardless of having been 
aggregated or analyzed) of human or environmental exposure assessments 
and toxicity tests for either human health effects or ecological other 
environmental effects.

F. What is the rationale for adding the 16 chemical substances?

    EPA assessment of chemical substances under TSCA section 6 involves 
a three-stage process: (1) prioritization, (2) risk evaluation, and, as 
applicable, (3) risk management. Prioritization and risk evaluation are 
carried out in accordance with procedural regulations at 40 CFR part 
702, subparts A and B, respectively.
    During prioritization, EPA identifies chemical substances that are 
candidates for prioritization and then uses reasonably available 
information to screen each candidate chemical substance against certain 
criteria and considerations specified in TSCA section 6(b)(1)(A):
     The hazard and exposure potential of the chemical 
substance;
     Persistence and bioaccumulation of the chemical substance;
     Potentially exposed or susceptible subpopulations;
     Storage near significant sources of drinking water;
     The conditions of use or significant changes in the 
conditions of use of the chemical substance (Conditions of use is 
defined under TSCA section 3(4) to mean ``the circumstances, as 
determined by the Administrator, under which a chemical substance is 
intended, known, or reasonably foreseen to be manufactured, processed, 
distributed in commerce, used or disposed of.'');
     The volume or significant changes in the volume of the 
chemical substance manufactured or processed; and
     Other risk-based criteria that EPA determines to be 
relevant to the designation of the chemical substance's priority.
    EPA identified 15 chemical substances that are the subject of this 
proposal as potential candidates for prioritization based on a 
screening process that is based on a combination of hazard, exposure 
(including uses), and persistence and bioaccumulation characteristics. 
To support the prioritization process as well as to inform its risk 
evaluation findings on any of these substances that EPA might designate 
as a high-priority substance, EPA is seeking unpublished health and 
safety studies on these chemical substances to ensure that such studies 
are available to EPA to inform any activities undertaken pursuant to 
TSCA section 6. EPA is also including the 6PPD transformation product, 
2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione 
(6PPD-quinone) (CASRN: 2754428-18-5) due to a response to a recent 
citizen's petition filed under TSCA section 21 received on 6PPD and 
6PPD-quinone. Cited in the petition are the potential impacts of 6PPD-
quinone to aquatic organisms and on population levels for some fish, 
such as the coho salmon. The Agency is including this chemical in this 
proposed request for unpublished health and safety studies to address 
data needs and to better understand and characterize risks associated 
with this chemical. For details on 6PPD and 6PPD-quinone and EPA's 
current key actions to address this chemical, please visit, https://www.epa.gov/chemical-research/6ppd-quinone.
    Information received pursuant to the final rule will help inform 
other EPA activities involving such chemical substances. Additionally, 
non-CBI information collected pursuant to the final rule would be made 
public via ChemView.
    Estimated benefits of the final rule include addressing market 
failure stemming from incomplete or imperfect information regarding the 
hazards associated with the listed chemicals. This final rule addresses 
market failure by making information about the health and safety 
effects of the listed chemicals available to EPA. By making this 
information available, EPA will be able to base decisions on actual 
data rather than relying on assumptions. Additionally, the information 
provided by this rule can aid in addressing negative externalities that 
occur when the costs associated with known hazards are external to 
manufacturers' decision-making and may result in overuse and/or 
overproduction of certain harmful products.

III. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA. For more information about these 
references, please consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.

1. EPA. TSCA Section 8(d): Economic Impact Analysis for the Addition 
of Sixteen Chemicals to the Health and Reporting Data Rule (March 
2024).

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 14094: Modernizing Regulatory Review

    This action is not a significant regulatory action under 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 impose 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. 2703.01). 
This action requires the reporting of health and safety data to EPA by 
manufacturers of certain chemical substances to be added to the Health 
and Safety Data Reporting Rule. EPA intends to use information 
collected under the rule to assist in chemical assessments under TSCA, 
and to inform any additional work necessary under environmental 
protection mandates beyond TSCA. Submitters may designate information 
as confidential, trade secret, or proprietary. EPA has implemented 
procedures to protect any confidential, trade secret or proprietary 
information from disclosure. These procedures comply with TSCA

[[Page 20922]]

section 14 and EPA's confidentiality regulation, 40 CFR part 2, subpart 
B. This action requires the reporting of health and safety data to EPA 
by manufacturers of certain chemical substances to be added to the 
Health and Safety Data Reporting Rule. EPA intends to use information 
collected under the rule to assist in chemical assessments under TSCA, 
and to inform any additional work necessary under environmental 
protection mandates beyond TSCA. Submitters may designate information 
as confidential, trade secret, or proprietary.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    Consistent with the PRA, EPA is interested in comments about the 
accuracy of the burden estimate, and any suggested methods for 
minimizing respondent burden or improving the automated collection 
techniques for submitting health and safety data to the Agency.

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. The small entities subject to the requirements of 
this action are manufacturers of 16 chemicals to be added to the Health 
and Safety Data Reporting Rule. The Agency has determined that 44 out 
of 161 of the firms in the affected universe are small entities. Of 
those small firms, 13 may experience an impact of above 1% and 3 may 
have impacts above 3%. Details of this analysis are presented in the 
Economic Analysis of this rule (Ref. 1), which can be found in the 
docket.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandates 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 Orders 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. It does not have substantial direct 
effects on tribal government because this action relates to toxic 
chemical reporting under EPCRA section 313, which primarily affects 
private sector facilities. Thus, Executive Order 13175 does not apply 
to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to regulatory actions considered significant under 
section 3(f)(1) of Executive Order 12866 and that concern environmental 
health or safety risks that EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of Executive Order 13045.
    Since this is not a ``covered regulatory action,'' E.O. 13045 does 
not apply. However, the Policy on Children's Health does apply. 
Although this action does not concern an environmental health or safety 
risk, the information obtained from the reporting required by this rule 
will be used to inform the Agency's decision-making process regarding 
chemical substances to which children may be exposed. This information 
will also assist the Agency and others in determining whether the 
chemical substances included in this proposed rule present potential 
risks, allowing the Agency and others to take appropriate action to 
investigate and mitigate those risks.

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 a significant adverse effect on the supply, distribution 
or use of energy and has not otherwise been designated by the 
Administrator of the Office of Information and Regulatory Affairs as a 
significant energy action.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve any technical standards. As such, 
NTTAA section 12(d), 15 U.S.C. 272, does not apply to this action.

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

    EPA believes that this type of action does not directly impact 
human health or environmental conditions. Although this action does not 
directly impact human health or environmental conditions, EPA 
identifies and addresses environmental justice concerns in accordance 
with Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 
(88 FR 25251, April 26, 2023) by requiring reporting of unpublished 
health and safety data. This regulatory action requires the submission 
of unpublished health and safety data for 16 chemical substances that 
will result in more information being collected and provided to the 
public. All consumers of products made from these chemicals could 
benefit from data regarding the chemicals' health and environmental 
effects. By requiring reporting of these unpublished studies, EPA 
provides communities across the U.S. (including communities with 
environmental justice concerns) with access to these studies. This 
information can also be used by government agencies and others in 
determining the potential hazards and risks associated with the listed 
chemicals. Therefore, the informational benefits of the action will 
have a positive impact on the human health and environmental impacts on 
communities with environmental justice concerns.

List of Subjects in 40 CFR Part 716

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: March 20, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, for the reasons stated in the preamble, EPA is proposing 
to amend 40 CFR chapter I as follows:

[[Page 20923]]

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.  716.21 by adding paragraph (a)(11) to read as follows:


Sec.  716.21  Chemical specific reporting requirements.

    (a) * * *
    (11) For 4,4-Methylene bis(2-chloraniline) (101-14-4); 4-tert-
octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (140-66-9); 
Acetaldehyde (75-07-7); Acrylonitrile (107-13-1); Benzenamine (62-53-
3); Benzene (71-43-2); Bisphenol A (80-5-7); Ethylbenzene (100-41-4); 
Naphthalene (91-20-3); Vinyl Chloride (75-01-4); Styrene (100-42-5); 
Tribomomethane (Bromoform) (75-25-2); Triglycidyl isocyanurate (2451-
62-9); Hydrogen fluoride (7664-39-3); N-(1,3-Dimethylbutyl)-N'-phenyl-
p-phenylenediamine (6PPD) (793-24-8); and 2-anilino-5-[(4-methylpentan-
2-yl)amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (2754428-18-5), 
all unpublished studies on health effects (including toxicity studies 
(in vivo and in vitro) on carcinogenicity, reproductive and 
developmental effects, genotoxicity, neurotoxicity, immunotoxicity, 
endocrine effects, and other systemic toxicity); toxicokinetics 
(absorption, distribution, metabolism, or elimination), including 
modelling studies, in humans or animals; environmental effects; 
environmental fate; physical-chemical properties if performed as 
described in 40 CFR 716.50; and occupational (both users and non-
users), general population, consumer, bystander, and environmental 
exposure must be submitted. Studies showing any measurable content of 
the substance in the tested substance (single substances or mixture) 
must be reported. The composition and purity of test substances must be 
reported if included as part of the study. Studies previously submitted 
to EPA pursuant to a requirement under TSCA or of the submitter's own 
accord and studies conducted or to be conducted pursuant to a TSCA 
section 4 action are exempt from the submission of lists of health and 
safety studies required under 40 CFR 716.35 and the submission of 
studies required under this rule.
* * * * *
0
3. Amend Sec.  716.120 by adding alphabetically in the table under 
paragraph (d) entries for -``4,4-Methylene bis(2-chloraniline);'' ``4-
tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol);'' 
``Acetaldehyde;'' ``Acrylonitrile;'' ``Benzenamine;'' ``Benzene;'' 
``Bisphenol A;'' ``Ethylbenzene;'' ``Naphthalene;'' ``Vinyl Chloride;'' 
``Styrene;'' ``Tribomomethane (Bromoform);'' ``Triglycidyl 
isocyanurate;'' ``Hydrogen fluoride;'' and ``N-(1,3-Dimethylbutyl)-N'-
phenyl-p-phenylenediamine (6PPD);'' and '' 2-anilino-5-[(4-
methylpentan-2-yl)amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone)'' 
to read as follows:


Sec.  716.120  Substance and listed mixtures to which this subpart 
applies.

    (d) * * *

----------------------------------------------------------------------------------------------------------------
            Category                 CAS No.        Special exemptions      Effective date        Sunset date
----------------------------------------------------------------------------------------------------------------
4,4-Methylene bis(2-                   101-14-4  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
 chloraniline).                                   applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
4-tert-octylphenol(4-(1,1,3,3-         140-66-9  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
 Tetramethylbutyl)-phenol).                       applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Acetaldehyde...................         75-07-0  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Acrylonitrile..................        107-13-1  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Benzenamine....................         62-53-3  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply applies; Sec.
                                                  716.20(a)(9) does not
                                                  apply.
Benzene........................         71-43-2  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Bisphenol A....................         80-05-7  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Ethylbenzene...................        100-41-4  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Naphthalene....................         91-20-3  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Vinyl Chloride.................         75-01-4  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Styrene........................        100-42-5  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Tribomomethane (Bromoform).....         75-25-2  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
Triglycidyl isocyanurate.......       2451-62-9  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.

[[Page 20924]]

 
Hydrogen fluoride..............       7664-39-3  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
                                                  applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
N-(1,3-Dimethylbutyl)-N'-phenyl-       793-24-8  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
 p-phenylenediamine (6PPD).                       applies; Sec.            DATE OF FINAL       DATE OF FINAL
                                                  716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
2-anilino-5-[(4-methylpentan-2-    2754428-18-5  Sec.   716.21(a)(11)     [TBD 30 DAYS AFTER  [TBD 90 DAYS AFTER
 yl) amino]cyclohexa-2,5-diene-                   applies; Sec.            DATE OF FINAL       DATE OF FINAL
 1,4-dione (6PPD-quinone).                        716.20(a)(9) does not    RULE].              RULE].
                                                  apply.
----------------------------------------------------------------------------------------------------------------


[FR Doc. 2024-06303 Filed 3-25-24; 8:45 am]
BILLING CODE 6560-50-P