[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Certain Existing Chemicals; Request To Submit Unpublished Health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substances to submit copies and lists of certain unpublished health and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
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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.
* * * * *
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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