Certain Existing Chemicals; Request To Submit Unpublished Health and Safety Data Under the Toxic Substances Control Act (TSCA), 100756-100763 [2024-29406]
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100756
Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
placing a site on the NPL does not mean
that any remedial or removal action
necessarily need be taken.
This action is not subject to Executive
Order 13211, because it is not a
significant regulatory action under
Executive Order 12866.
K. Congressional Review Act
This action is subject to the CRA, and
the EPA will submit a rule report to
each House of the Congress and to the
Comptroller General of the United
States. This action is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
Provisions of the Congressional
Review Act (CRA) or section 305 of
CERCLA may alter the effective date of
this regulation. Under 5 U.S.C.
801(b)(1), a rule shall not take effect, or
continue in effect, if Congress enacts
(and the President signs) a joint
resolution of disapproval, described
under section 802. Another statutory
provision that may affect this rule is
CERCLA section 305, which provides
for a legislative veto of regulations
promulgated under CERCLA. Although
INS v. Chadha, 462 U.S. 919,103 S. Ct.
2764 (1983), and Bd. of Regents of the
University of Washington v. EPA, 86
F.3d 1214,1222 (D.C. Cir. 1996), cast the
validity of the legislative veto into
question, the EPA has transmitted a
copy of this regulation to the Secretary
of the Senate and the Clerk of the House
of Representatives.
If action by Congress under either the
CRA or CERCLA section 305 calls the
effective date of this regulation into
question, the EPA will publish a
document of clarification in the Federal
Register.
I. National Technology Transfer and
Advancement Act (NTTAA)
This rulemaking does not involve
technical standards.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The EPA believes the human health or
environmental risk addressed by this
action will not have potential
disproportionately high and adverse
human health or environmental effects
on minority, low-income or indigenous
populations because it does not affect
the level of protection provided to
human health or the environment. As
discussed in section I.C. of the preamble
to this action, the NPL is a list of
national priorities. The NPL is intended
primarily to guide the EPA in
determining which sites warrant further
investigation to assess the nature and
extent of public health and
environmental risks associated with a
release of hazardous substances,
pollutants or contaminants. The NPL is
of only limited significance as it does
not assign liability to any party. Also,
List of Subjects in 40 CFR Part 300
Environmental protection, Air
pollution control, Chemicals, Hazardous
substances, Hazardous waste,
Intergovernmental relations, Natural
resources, Oil pollution, Penalties,
Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
Barry N. Breen,
Principal Deputy Assistant Administrator,
Office of Land and Emergency Management.
For the reasons set out in the
preamble, the Environmental Protection
Agency amends title 40, chapter I, part
300, of the Code of Federal Regulations
as follows:
PART 300—NATIONAL OIL AND
HAZARDOUS SUBSTANCES
POLLUTION CONTINGENCY PLAN
1. The authority citation for part 300
continues to read as follows:
■
Authority: 33 U.S.C. 1251 et seq.; 42
U.S.C. 9601–9657; E.O. 13626, 77 FR 56749,
3 CFR, 2013 Comp., p. 306; E.O. 12777, 56
FR 54757, 3 CFR, 1991 Comp., p. 351; E.O.
12580, 52 FR 2923, 3 CFR, 1987 Comp., p.
193.
2. Amend table 1 of Appendix B to
part 300 by adding the entry for ‘‘WA,
Upper Columbia River’’, in alphabetical
order, to read as follows:
■
Appendix B to Part 300—National
Priorities List
TABLE 1—GENERAL SUPERFUND SECTION
State
Site name
*
WA .........................
*
*
Upper Columbia River ..........................
*
*
Notes a
City/county
*
Upper Columbia River.
*
*
*
*
*
*
*
*
a A = Based on issuance of health advisory by Agency for Toxic Substances and Disease Registry (if scored, HRS score need not be greater
than or equal to 28.50).
*
*
*
*
*
[FR Doc. 2024–29006 Filed 12–12–24; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
BILLING CODE 6560–50–P
40 CFR Part 716
[EPA–HQ–OPPT–2023–0360; FRL–11164–
02–OCSPP]
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RIN 2070–AL15
Certain Existing Chemicals; Request
To Submit Unpublished Health and
Safety Data Under the Toxic
Substances Control Act (TSCA)
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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The Environmental Protection
Agency (EPA or Agency) is finalizing
the Health and Safety Reporting Rule
under the Toxic Substance Control Act
(TSCA) to require manufacturers
(including importers) of the sixteen
chemical substances identified in this
rulemaking to submit copies and lists of
certain unpublished health and safety
studies to EPA. Health and safety
studies sought by this action will inform
EPA actions in carrying out its
responsibilities pursuant to TSCA,
including prioritization, risk evaluation,
and risk management.
SUMMARY:
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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations
This rule is effective on January
13, 2025.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2023–0360, is
available online at https://
www.regulations.gov. Additional
information about dockets generally,
along with instructions for visiting the
docket in-person, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Lameka
Smith, 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)
564–1629; email address:
smith.lameka@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
DATES:
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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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 North American
Industrial Classification System
(NAICS) codes affected by this rule are
those that align with these activities.
This typically includes manufacturing
and chemical processing sectors, as well
as any related industries where these
chemicals might be used or introduced
into commerce, including those who fall
within the following list of NAICS
codes:
• Chemical manufacturing (NAICS
code 325); and
• 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
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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 requiring manufacturers of
chemical substances listed in this
document to submit copies and lists of
certain unpublished health and safety
studies to EPA. EPA is taking final
action on the proposed rule published
on March 26, 2024 (89 FR 20918 (FRL–
11164–01–OCSPP). This rulemaking is
intended to provide EPA with useful
information for prioritization, risk
evaluations, and risk management
activities under TSCA section 6
regarding the chemical substances
identified in this final rule. This action
lists the chemical substances and their
Chemical Abstracts Service Registry
Numbers (CASRNs) being added to 40
CFR 716. It also lists 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
finalizing this rule under its authority in
TSCA section 8(d) to require 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
for the addition of the 16 chemical
substances to the TSCA section 8(d)
Health and Safety Data Reporting rule
(Ref. 1), which is available in the docket
and summarized here. EPA estimates
that the costs of this action will be
approximately $5,884,568 in the first
year of reporting and involve 70,630
burden hours (Ref. 1). In addition, EPA
has determined that, of the 35 small
businesses affected by this action, 2 are
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 (Ref. 1).
II. Background
A. What chemical substances is EPA
adding to the final rule?
EPA is amending the list at 40 CFR
716.120 to add 16 chemical substances.
The list at 40 CFR 716.120 contains
chemical substances for which the
health and safety study data reporting is
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required. Additionally, the chemical
specific reporting requirements will be
incorporated into 40 CFR 716.21(a)(11).
Any special exemptions are required for
a specific chemical substance are
identified in the table at 40 CFR 716.120
under special exemptions. Special
exemptions are reporting requirements
that are specific to a chemical substance
and include specific language about
specific studies and requirements. The
chemical substances addressed in this
final rule are as follows:
• 4,4-Methylene bis(2-chloraniline)
(CASRN 101–14–4);
• 4-tert-octylphenol(4-(1,1,3,3Tetramethylbutyl)-phenol) (CASRN
140–66–9);
• Acetaldehyde (CASRN 75–07–0);
• 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);
• Tribromomethane (Bromoform)
(CASRN 75–25–2);
• Triglycidyl isocyanurate; (CASRN
2451–62–9);
• Hydrogen fluoride (CASRN 7664–
39–3);
• N-(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (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 reporting requirements?
Listed in Unit II. are the reporting
requirements for the 16 chemical
substances identified in Unit II.A.
Generally, the reporting described in
Unit II.D. is required by March 13, 2025.
The specific types of health and safety
studies are listed in Unit II.D. and
include the following:
• 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, 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 part 716.
• Manufacturers who, either at the
time of or after the chemical substance
is listed in 40 CFR 716, propose to
manufacture or are manufacturing the
listed chemical substance must submit
to EPA during the 60-day reporting
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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.
• For this rulemaking, EPA is
requiring submission of information
only on those studies in which the
listed chemical is specifically identified
in the studies.
Any person who manufactures
(including imports) or who proposes to
manufacture the listed chemical
substance from January 13, 2025 to
March 13, 2025 must:
(1) Inform EPA (by submitting a list)
of any studies initiated during the
period from January 13, 2025 to March
13, 2025 within 30 days of their
initiation, but in no case later than April
14, 2025; and
(2) For those who submitted lists of
studies that were ongoing or initiated
during the period from January 13, 2025
to March 13, 2025, such persons 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
rule?
Requirements for reporting
unpublished health and safety data is
provided at 40 CFR part 716, and with
explanations of reporting exemptions
detailed in 40 CFR 716.20. As explained
in the proposed rule (89 FR 20918
March 26, 2024 (FRL–11164–01–
OCSPP)), EPA did not include the
exemption listed at 40 CFR 716.20(a)(9),
which allows for the inclusion of an
exemption for persons manufacturing a
substance only as an impurity. A person
manufacturing or proposing to
manufacture a substance listed in this
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rule must report on the substance where
it was only manufactured (or is being
proposed for manufacturing) as an
impurity. An impurity is defined at 40
CFR 716.3 as a chemical substance that
is unintentionally present with another
chemical substance. Additionally,
pursuant to the procedure at 40 CFR
716.20(b)(5) that requires EPA to
identify the chemical grade/purity, EPA
is requiring reporting on any chemical
grade/purity level of the chemical.
EPA is requiring 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, or within
a mixture, formulated product, or article
that contains the subject chemical
substance. This includes instances
where the chemical substance is
manufactured only as an impurity. EPA
considers conditions of use, as
discussed in further detail in Unit II. F.,
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 (see e.g., 89 FR
37028, 37033 (‘‘[EPA must include
consideration of] known circumstances
associated with the chemical (e.g., [. . .]
de minimis amounts such as an
impurity or within an article, etc.)’’)).
For this rulemaking, EPA is requiring
submission of information only on those
studies in which the listed chemical is
specifically identified in the studies.
Accordingly, the chemicals included
in this final rule 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 designation, EPA is
required to initiate a risk evaluation
under TSCA section 6(b). 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.
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
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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 physicalchemical properties if performed as
described in 40 CFR 716.50.
• All unpublished studies on
occupational, general population,
consumer, bystander, 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 listed substance (single
substance or mixture). The composition
and purity of test substances must be
reported if included as part of the study.
• 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 relating to
chemical substances offered for
commercial distribution or subject to
reporting under TSCA Section 4 or 5 is
not protected from disclosure, with
limited exceptions as stated in 15 U.S.C.
2613(2)(B).
The following types of information
are not included in this action and need
not be submitted to EPA:
• 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.
• Certain types of studies when the
subject of the study is a mixture known
to contain a listed substance. These
studies include acute oral toxicity; acute
dermal toxicity; acute inhalation
toxicity; primary eye irritation; primary
dermal irritation; dermal sensitization;
and physical-chemical properties.
• Analyzed aggregations of
monitoring data when either based on
monitoring data acquired over five years
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prior to the date of this rule, or when
the data are not analyzed to determine
the exposure or concentration levels of
the listed chemical.
E. How to report?
All submitters must report TSCA
section 8(d) data electronically using the
Chemical Safety and Pesticide Programs
(CSPP) Software, which is 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 at https://www.epa.gov/assessingand-managing-chemicals-under-tsca/
section-8d-health-safety-data-reportinguser-guide-0. Submitters may also
contact EPA’s TSCA Hotline at tscahotline@epa.gov 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 CBI. 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, and using the CSPP Software.
Requirements for asserting and
maintaining confidentiality claims are
described in 40 CFR 703.5. Such claims
must be made concurrent with
submission of the information. If no
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, and, on each page containing
information claimed as confidential, the
respondent must indicate what
information, if any, is claimed as
confidential by marking the specific
information on that 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
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‘‘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 OECD harmonized
templates. Additionally, EPA is
requiring all existing information
concerning health and environmental
effects and that have CBI claims as
described in Unit II.E.1. to be submitted
in the format of Organization of
Economic Cooperation and
Development’s (OECD) harmonized
templates (OHTs), where such templates
exist for the type of data pursuant to 40
CFR 703. OECD templates are accessible
to the public online at https://oecd.org/
ehs/templates/harmonisedtemplates.htm. This can be
accomplished by using the freely
available IUCLID6 software by exporting
the dossier in the OECD Harmonized
Template working context. EPA can
accept any dossiers generated using any
version of IUCLID6 available at https://
www.epa.gov/tsca-cbi/final-rulerequirements-confidential-businessinformation-claims-undertsca#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 OHT is not available for a
particular endpoint for which the
manufacturer has relevant information,
then the manufacturer must still submit
the study under 40 CFR 716.
This rule does not require the
submission of OHTs for health and
safety studies that do not have CBI
claims. As explained in the Response to
Comments document (Ref. 2), 40 CFR
703.5(g) already requires that studies
containing CBI claims be submitted
using OHTs. However, EPA is declining
to extend this requirement to those
studies without CBI claims. Forgoing an
OHT requirement for non-CBI claims
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alleviates some of the overall
submission burden. However, EPA
welcomes any OHTs for those non-CBI
studies, especially if they have already
been prepared pursuant to other
authorities (e.g., REACH). EPA also
advises manufacturers that it reserves
the authority to promulgate OHT
requirements for non-CBI health and
safety studies in future rulemakings and
anticipates doing so.
F. What is the rationale for adding the
16 chemical substances?
EPA’s 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):
• 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;
• 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.’’;
• 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
rule 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
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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-[(4methylpentan-2-yl) amino]cyclohexa2,5-diene-1,4-dione (6PPD-quinone)
(CASRN: 2754428–18–5) in response to
a citizen’s petition filed under TSCA
section 21 regarding 6PPD and 6PPDquinone. 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 request for unpublished
health and safety studies to address data
needs and to better understand and
characterize potential 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 this
rulemaking will help inform other EPA
activities involving these chemical
substances. Additionally, non-CBI
collected pursuant to this final rule will
be made public via ChemView (https://
chemview.epa.gov/chemview/), the EPA
online system that contains information
EPA receives and develops about
chemicals regulated under TSCA.
ChemView is part of EPA’s commitment
to strengthen its chemicals management
programs by improving access to and
the usefulness of chemical information.
The goal is for people to easily get
information they need to make safe
chemical choices and to help
businesses, individuals and others make
more informed decisions about the
chemicals they use.
Benefits of this 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’ decisionmaking and may result in overuse and/
or overproduction of certain harmful
products.
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III. Summary of Public Comments on
the Proposed Rule
EPA received 35 unique public
comments during the public comment
period for the proposed rule (89 FR
20918, March 26, 2024 (FRL–11164–01–
OCSPP)). Comments were submitted by
citizens, industry groups and
companies, non-governmental
organizations, and a state agency. The
public comments revealed varied
perspectives across different types of
commenters.
Industry stakeholders were generally
supportive of the need for
comprehensive chemical data under
TSCA section 6. Some industry
commenters, however, expressed
concerns about the utility of studies
involving low concentrations of
chemicals or cases in which the
chemical is not the test substance (e.g.,
included in the study as an impurity of
the test substance or test mixture). Many
such commenters were not supportive
of EPA lifting the impurity exemption
and/or requiring the submission of
studies with the listed chemical
substance at any concentration or
purity. Several industry commenters
also discussed the proposed OHTs
requirement, with different points of
view. While some supported the use of
templated and standardized
submissions, others expressed concerns
about the administrative and financial
burdens of compliance, particularly
with reporting on impurities. Some
industry stakeholders suggested
extending the reporting deadlines from
90 to 180 days to allow more time for
compliance. Finally, many comments
from companies or trade groups
discussed EPA’s draft burden analysis,
with many claiming that EPA had
underestimated the time and cost
related to preparing and submitting
OHTs.
Environmental groups and NGOs
strongly supported the rule as proposed,
including the requirement to submit
studies with the chemical substances
even when present as impurities. These
commenters also highlighted the
importance of gathering data on 6PPD
and its degradant, 6PPD-quinone, and
urged EPA to finalize this rule quickly.
EPA considered all comments and
information in the development of this
final rule. A comprehensive response to
comments document can be found in
the docket (Ref. 2).
IV. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
includes these documents and other
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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. December 2024.
2. EPA. Response to Comments. TSCA
Section 8(d) Certain Existing Chemicals;
Request to Submit Unpublished Health
and Safety Data Under TSCA. December
2024.
3. EPA. Supporting Statement under the
Paperwork Reduction Act: Section 8 of
the Toxic Substances Control Act. EPA
ICR No. 2703.01 OMB Control No. 2070–
0224. November 2022.
V. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/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)
As required by the PRA, 44 U.S.C.
3501 et seq., the information collection
activities associated with TSCA section
8(d) reporting are approved by OMB
under OMB Control No. 2070–0224. The
Information Collection Request (ICR)
document that EPA prepared has been
assigned EPA ICR No. 2703.01 (Ref. 3).
A copy of the approved ICR is in the
docket for this rule, and is briefly
summarized here.
This action requires the reporting of
unpublished health and safety studies to
EPA by manufacturers of certain
chemical substances that are being
added to the Health and Safety Data
Reporting Rule in 40 CFR part 716. EPA
intends to use the information collected
to assist in assessing the chemical
substances 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 section
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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations
14 and EPA’s confidentiality
regulations, 40 CFR part 2, subpart B.
Respondents/affected entities:
Manufacturers (including importers) of
the 16 chemical substances identified in
the rulemaking, see also Unit I.A. and
the ICR.
Respondent’s obligation to respond:
Mandatory, TSCA section 8(d) (15
U.S.C. 2607(d)), and implementing
regulations in 40 CFR part 716.
Estimated number of respondents:
160.
Frequency of response: One-time.
Total estimated burden: 23,962 hours
(per year). Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: $2,011,604 (per
year), with no annualized capital or
operation & maintenance costs. (Ref. 1)
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.
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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 35 out of 160 of the
firms in the affected universe are small
entities. Of those small firms, 2 may
experience an impact of above 1% and
1 may have impacts above 3%. Details
of this analysis are presented in Chapter
6 of the Economic Analysis for this rule
(Ref. 1), which can be found in the
docket.
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million
(adjusted annually for inflation) or more
(in 1995 dollars) as described in UMRA,
2 U.S.C. 1531–1538, and does not
significantly or uniquely affect small
governments. The costs involved in this
action are estimated not to exceed $183
million in 2023$ ($100 million in 1995$
adjusted for inflation using the GDP
implicit price deflator) or more in any
one year.
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,
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100761
on the relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
I. National Technology Transfer and
Advancement Act (NTTAA)
F. Executive Orders 13175: Consultation
and Coordination With Indian Tribal
Governments
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
This action does not have tribal
implications as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000) because it will not have
substantial direct effects on tribal
governments, on the relationship
between the Federal government and
the Indian tribes, or on the distribution
of power and responsibilities between
the Federal government and Indian
tribes. This rule affects entities who
manufacture (including import)
chemical substances for commercial
purposes. 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 directly concern an
environmental health or safety risk to
children, 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 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 subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because it is not a significant
regulatory action under Executive Order
12866.
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This rulemaking does not involve
technical standards under the NTTAA
section 12(d), 15 U.S.C. 272.
The EPA believes that this type of
action does not concern human health
or environmental conditions and
therefore cannot be evaluated with
respect to potentially disproportionate
and adverse effects on communities
with environmental justice concerns.
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 available for EPA’s use under
TSCA section 6, thereby enabling the
Agency to better protect human health
and the environment, including in lowincome and minority communities.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5
U.S.C. 801 et seq., and EPA will submit
a rule report to each House of the
Congress and to the Comptroller General
of the United States. This action is not
a ‘‘major rule’’ under 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 716
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: December 10, 2024.
Michal Freedhoff,
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
1. The authority citation for part 716
continues to read as follows:
■
Authority: 15 U.S.C. 2607(d).
2. Amend § 716.21 by adding
paragraph (a)(11) to read as follows:
■
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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations
§ 716.21 Chemical specific reporting
requirements.
(a) * * *
(11) For 4,4-Methylene bis(2chloraniline) (101–14–4); 4-tertoctylphenol(4-(1,1,3,3Tetramethylbutyl)-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-pphenylenediamine (6PPD) (793–24–8);
and 2-anilino-5-[(4-methylpentan-2yl)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.
*
*
*
*
*
3. In § 716.120, amend the table in
paragraph (d) by:
■
a. Designating the table as table 3 to
paragraph (d);
■ b. Adding the category sub-heading
‘‘OPPT 2024 Chemicals:’’ in
alphabetical order immediately
preceding the category ‘‘Organohalogen
flame retardants:’’; and
■ c Adding the entries ‘‘Acetaldehyde’’;
‘‘Acrylonitrile’’; ‘‘2-anilino-5-[(4methylpentan-2-yl)amino]cyclohexa2,5-diene-1,4-dione (6PPD-quinone)’’;
‘‘Benzenamine’’; ‘‘Benzene’’; ‘‘Bisphenol
A’’; ‘‘Ethylbenzene’’; ‘‘Hydrogen
fluoride’’; ‘‘4,4-Methylene bis(2chloraniline)’’; ‘‘N-(1,3-Dimethylbutyl)N′-phenyl-p-phenylenediamine
(6PPD)’’; ‘‘Naphthalene’’; ‘‘Styrene’’; ‘‘4tert-octylphenol(4-(1,1,3,3Tetramethylbutyl)-phenol)’’;
‘‘Tribomomethane (Bromoform)’’;
‘‘Triglycidyl isocyanurate’’; and ‘‘Vinyl
Chloride’’ after the category sub-heading
‘‘OPPT 2024 Chemicals:’’.
The additions read as follows:
■
§ 716.120 Substances and listed mixtures
to which this subpart applies.
(d) * * *
TABLE 3 TO PARAGRAPH (d)
Category
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*
CAS No.
*
*
*
OPPT 2024 Chemicals
Acetaldehyde ..........................................
75–07–0
Acrylonitrile ..............................................
107–13–1
2-anilino-5-[(4-methylpentan-2yl)amino]cyclohexa-2,5-diene-1,4dione (6PPD-quinone).
Benzenamine ..........................................
2754428–18–5
Benzene ..................................................
71–43–2
Bisphenol A .............................................
80–05–7
Ethylbenzene ..........................................
100–41–4
Hydrogen fluoride ....................................
7664–39–3
4,4-Methylene bis(2-chloraniline) ............
101–14–4
N-(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (6PPD).
Naphthalene ............................................
793–24–8
Styrene ....................................................
100–42–5
4-tert-octylphenol(4-(1,1,3,3Tetramethylbutyl)-phenol).
Tribomomethane (Bromoform) ................
140–66–9
Triglycidyl isocyanurate ...........................
2451–62–9
Vinyl Chloride ..........................................
75–01–4
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62–53–3
91–20–3
75–25–2
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Special exemptions
Effective date
*
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
§ 716.21(a)(11) applies; § 716.20(a)(9)
does not apply.
Frm 00042
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*
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*
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January 13, 2025 ....
March 13, 2025.
January 13, 2025 ....
March 13, 2025.
January 13, 2025 ....
March 13, 2025.
January 13, 2025 ....
March 13, 2025.
January 13, 2025 ....
March 13, 2025.
January 13, 2025 ....
March 13, 2025.
January 13, 2025 ....
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E:\FR\FM\13DER1.SGM
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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations
100763
TABLE 3 TO PARAGRAPH (d)—Continued
Category
*
CAS No.
*
*
*
Effective date
*
Geanelle G. Herring, (410) 786–4466.
Christopher S. Wilson, (410) 786–
3178.
[FR Doc. 2024–29406 Filed 12–12–24; 8:45 am]
BILLING CODE 6560–50–P
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Executive Summary and Severability
Office of the Secretary
A. Purpose
45 CFR Parts 162
We published a proposed rule titled
‘‘Administrative Simplification:
Modifications of Health Insurance
Portability and Accountability Act of
1996 (HIPAA) National Council for
Prescription Drug Programs (NCPDP)
Retail Pharmacy Standards; and
Adoption of Pharmacy Subrogation
Standard’’ (hereafter referred to as the
November 2022 proposed rule) that
appeared in the November 9, 2022,
Federal Register (87 FR 67634). In that
rule, we proposed to adopt
modifications to the retail pharmacy
and Medicaid subrogation standards.
This final rule adopts modifications to
standards for electronic retail pharmacy
transactions and the Medicaid
pharmacy subrogation transaction
adopted under the Administrative
Simplification subtitle of the Health
Insurance Portability and
Accountability Act of 1996 (HIPAA).
[CMS–0056–F]
RIN 0938–AU19
Administrative Simplification:
Modifications of Health Insurance
Portability and Accountability Act of
1996 (HIPAA) National Council for
Prescription Drug Programs (NCPDP)
Retail Pharmacy Standards; and
Modification of the Medicaid Pharmacy
Subrogation Standard
Office of the Secretary,
Department of Health and Human
Services (HHS).
ACTION: Final rule.
AGENCY:
This final rule adopts updated
versions of the retail pharmacy
standards for electronic transactions
adopted under the Administrative
Simplification subtitle of the Health
Insurance Portability and
Accountability Act of 1996 (HIPAA).
These updated versions are
modifications to the currently adopted
standards for the following retail
pharmacy transactions: health care
claims or equivalent encounter
information; eligibility for a health plan;
referral certification and authorization;
and coordination of benefits. This final
rule also adopts a modification to the
standard for the Medicaid pharmacy
subrogation transaction.
DATES:
Effective Date: This final rule is
effective on February 11, 2025. The
incorporation by reference of certain
publications listed in the rule is
approved by the Director of the Federal
Register beginning February 11, 2025.
The incorporation by reference of
certain other publications listed in the
rule was approved by the Director as of
March 17, 2009.
Compliance Date: Compliance with
this final rule is required beginning
February 11, 2028.
FOR FURTHER INFORMATION CONTACT:
SUMMARY:
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Special exemptions
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Jkt 265001
1. Need for the Regulatory Action
The modified standards adopted in
this rule will benefit the health care
industry by offering more robust data
exchange and workflow automation,
enhanced patient safety, improved
coordination of benefits, and expanded
financial fields, so that entities may not
have to manually enter free text, split
claims, or prepare and submit a paper
Universal Claim Form. The current
retail pharmacy standards adopted in
2009 remain unchanged. In 2018, the
National Committee on Vital and Health
Statistics (NCVHS) recommended that
HHS adopt more recent standards to
address evolving industry business
needs. Consistent with the NCVHS
recommendations and collaborative
industry and stakeholder input, we
believe the updated retail pharmacy
standards we are adopting are
sufficiently mature for adoption and
that covered entities are ready to
implement them.
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*
Sunset date
*
2. Legal Authority for the Regulatory
Action
Through subtitle F of title II of
HIPAA, Congress added to title XI of the
Social Security Act (the Act) a new Part
C, titled ‘‘Administrative
Simplification,’’ which requires the
Secretary of the Department of Health
and Human Services (the Secretary) to
adopt standards for certain transactions
to enable health information to be
exchanged more efficiently and to
achieve greater uniformity in the
transmission of health information.
More specifically, section 1174 of the
Act requires the Secretary to review the
adopted standards and adopt
modifications to them, including
additions to the standards, as
appropriate, but not more frequently
than once every 12 months, unless the
Secretary determines that the
modification is necessary in order to
permit compliance with the standard,
thus providing the legal authority for
this regulatory action.
B. Summary of the Major Provisions
The provisions in this final rule adopt
the following modifications: the NCPDP
Telecommunication Standard
Implementation Guide, Version F6
(Version F6) and equivalent NCPDP
Batch Standard Implementation Guide,
Version 15 (Version 15) and NCPDP
Batch Standard Subrogation
Implementation Guide, Version 10
(Version 10). These updated standards
will replace the currently adopted
NCPDP Telecommunication Standard
Implementation Guide, Version D,
Release 0 (Version D.0) and the
equivalent NCPDP Batch Standard
Implementation Guide, Version 1,
Release 2 (Version 1.2), and NCPDP
Batch Standard Medicaid Subrogation
Implementation Guide, Version 3,
Release 0 (Version 3.0).
Version 3.0 was adopted to support
Federal and State requirements for State
Medicaid agencies to seek
reimbursement from the health plan
responsible for paying the pharmacy
claim after the State Medicaid agency
has paid the claim on behalf of the
Medicaid recipient.
In the November 2022 proposed rule,
we proposed to broaden the scope of the
subrogation transaction to apply not
only to State Medicaid agencies but to
E:\FR\FM\13DER1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 240 (Friday, December 13, 2024)]
[Rules and Regulations]
[Pages 100756-100763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29406]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 716
[EPA-HQ-OPPT-2023-0360; FRL-11164-02-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: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or Agency) is
finalizing the Health and Safety Reporting Rule under the Toxic
Substance Control Act (TSCA) to require manufacturers (including
importers) of the sixteen chemical substances identified in this
rulemaking to submit copies and lists of certain unpublished health and
safety studies to EPA. Health and safety studies sought by this action
will inform EPA actions in carrying out its responsibilities pursuant
to TSCA, including prioritization, risk evaluation, and risk
management.
[[Page 100757]]
DATES: This rule is effective on January 13, 2025.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2023-0360, is available online
at https://www.regulations.gov. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Lameka Smith, 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) 564-1629; 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. Executive Summary
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 North American
Industrial Classification System (NAICS) codes affected by this rule
are those that align with these activities. This typically includes
manufacturing and chemical processing sectors, as well as any related
industries where these chemicals might be used or introduced into
commerce, including those who fall within the following list of NAICS
codes:
Chemical manufacturing (NAICS code 325); and
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 is requiring manufacturers of chemical substances listed in
this document to submit copies and lists of certain unpublished health
and safety studies to EPA. EPA is taking final action on the proposed
rule published on March 26, 2024 (89 FR 20918 (FRL-11164-01-OCSPP).
This rulemaking is intended to provide EPA with useful information for
prioritization, risk evaluations, and risk management activities under
TSCA section 6 regarding the chemical substances identified in this
final rule. This action lists the chemical substances and their
Chemical Abstracts Service Registry Numbers (CASRNs) being added to 40
CFR 716. It also lists 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 finalizing this rule under its authority in TSCA
section 8(d) to require 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 for the addition of the 16
chemical substances to the TSCA section 8(d) Health and Safety Data
Reporting rule (Ref. 1), which is available in the docket and
summarized here. EPA estimates that the costs of this action will be
approximately $5,884,568 in the first year of reporting and involve
70,630 burden hours (Ref. 1). In addition, EPA has determined that, of
the 35 small businesses affected by this action, 2 are 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 (Ref. 1).
II. Background
A. What chemical substances is EPA adding to the final rule?
EPA is amending the list at 40 CFR 716.120 to add 16 chemical
substances. The list at 40 CFR 716.120 contains chemical substances for
which the health and safety study data reporting is required.
Additionally, the chemical specific reporting requirements will be
incorporated into 40 CFR 716.21(a)(11). Any special exemptions are
required for a specific chemical substance are identified in the table
at 40 CFR 716.120 under special exemptions. Special exemptions are
reporting requirements that are specific to a chemical substance and
include specific language about specific studies and requirements. The
chemical substances addressed in this final rule are as follows:
4,4-Methylene bis(2-chloraniline) (CASRN 101-14-4);
4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol)
(CASRN 140-66-9);
Acetaldehyde (CASRN 75-07-0);
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);
Tribromomethane (Bromoform) (CASRN 75-25-2);
Triglycidyl isocyanurate; (CASRN 2451-62-9);
Hydrogen fluoride (CASRN 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 reporting requirements?
Listed in Unit II. are the reporting requirements for the 16
chemical substances identified in Unit II.A. Generally, the reporting
described in Unit II.D. is required by March 13, 2025.
The specific types of health and safety studies are listed in Unit
II.D. and include the following:
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, 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 part 716.
Manufacturers who, either at the time of or after the
chemical substance is listed in 40 CFR 716, propose to manufacture or
are manufacturing the listed chemical substance must submit to EPA
during the 60-day reporting
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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.
For this rulemaking, EPA is requiring submission of
information only on those studies in which the listed chemical is
specifically identified in the studies.
Any person who manufactures (including imports) or who proposes to
manufacture the listed chemical substance from January 13, 2025 to
March 13, 2025 must:
(1) Inform EPA (by submitting a list) of any studies initiated
during the period from January 13, 2025 to March 13, 2025 within 30
days of their initiation, but in no case later than April 14, 2025; and
(2) For those who submitted lists of studies that were ongoing or
initiated during the period from January 13, 2025 to March 13, 2025,
such persons 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 rule?
Requirements for reporting unpublished health and safety data is
provided at 40 CFR part 716, and with explanations of reporting
exemptions detailed in 40 CFR 716.20. As explained in the proposed rule
(89 FR 20918 March 26, 2024 (FRL-11164-01-OCSPP)), EPA did not include
the exemption listed at 40 CFR 716.20(a)(9), which allows for the
inclusion of an exemption for persons manufacturing a substance only as
an impurity. A person manufacturing or proposing to manufacture a
substance listed in this rule must report on the substance where it was
only manufactured (or is being proposed for manufacturing) as an
impurity. An impurity is defined at 40 CFR 716.3 as a chemical
substance that is unintentionally present with another chemical
substance. Additionally, pursuant to the procedure at 40 CFR
716.20(b)(5) that requires EPA to identify the chemical grade/purity,
EPA is requiring reporting on any chemical grade/purity level of the
chemical.
EPA is requiring 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,
or within a mixture, formulated product, or article that contains the
subject chemical substance. This includes instances where the chemical
substance is manufactured only as an impurity. EPA considers conditions
of use, as discussed in further detail in Unit II. F., 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 (see e.g., 89 FR 37028, 37033 (``[EPA
must include consideration of] known circumstances associated with the
chemical (e.g., [. . .] de minimis amounts such as an impurity or
within an article, etc.)'')). For this rulemaking, EPA is requiring
submission of information only on those studies in which the listed
chemical is specifically identified in the studies.
Accordingly, the chemicals included in this final rule 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 designation, EPA is required to initiate a risk
evaluation under TSCA section 6(b). 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.
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, bystander, 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 listed
substance (single substance or mixture). The composition and purity of
test substances must be reported if included as part of the study.
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 relating to
chemical substances offered for commercial distribution or subject to
reporting under TSCA Section 4 or 5 is not protected from disclosure,
with limited exceptions as stated in 15 U.S.C. 2613(2)(B).
The following types of information are not included in this action
and need not be submitted to EPA:
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.
Certain types of studies when the subject of the study is
a mixture known to contain a listed substance. These studies include
acute oral toxicity; acute dermal toxicity; acute inhalation toxicity;
primary eye irritation; primary dermal irritation; dermal
sensitization; and physical-chemical properties.
Analyzed aggregations of monitoring data when either based
on monitoring data acquired over five years
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prior to the date of this rule, or when the data are not analyzed to
determine the exposure or concentration levels of the listed chemical.
E. How to report?
All submitters must report TSCA section 8(d) data electronically
using the Chemical Safety and Pesticide Programs (CSPP) Software, which
is 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 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 CBI. 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, and using the CSPP Software. Requirements for asserting
and maintaining confidentiality claims are described in 40 CFR 703.5.
Such claims must be made concurrent with submission of the information.
If no 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, and, on each page containing information claimed as
confidential, the respondent must indicate what information, if any, is
claimed as confidential by marking the specific information on that
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 OECD harmonized templates. Additionally, EPA is
requiring all existing information concerning health and environmental
effects and that have CBI claims as described in Unit II.E.1. to be
submitted in the format of Organization of Economic Cooperation and
Development's (OECD) harmonized templates (OHTs), where such templates
exist for the type of data pursuant to 40 CFR 703. 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 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 OHT is not available for a particular
endpoint for which the manufacturer has relevant information, then the
manufacturer must still submit the study under 40 CFR 716.
This rule does not require the submission of OHTs for health and
safety studies that do not have CBI claims. As explained in the
Response to Comments document (Ref. 2), 40 CFR 703.5(g) already
requires that studies containing CBI claims be submitted using OHTs.
However, EPA is declining to extend this requirement to those studies
without CBI claims. Forgoing an OHT requirement for non-CBI claims
alleviates some of the overall submission burden. However, EPA welcomes
any OHTs for those non-CBI studies, especially if they have already
been prepared pursuant to other authorities (e.g., REACH). EPA also
advises manufacturers that it reserves the authority to promulgate OHT
requirements for non-CBI health and safety studies in future
rulemakings and anticipates doing so.
F. What is the rationale for adding the 16 chemical substances?
EPA's 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):
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;
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.'';
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
rule 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
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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) in response to a citizen's petition
filed under TSCA section 21 regarding 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 request for
unpublished health and safety studies to address data needs and to
better understand and characterize potential 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 this rulemaking will help inform
other EPA activities involving these chemical substances. Additionally,
non-CBI collected pursuant to this final rule will be made public via
ChemView (https://chemview.epa.gov/chemview/), the EPA online system
that contains information EPA receives and develops about chemicals
regulated under TSCA. ChemView is part of EPA's commitment to
strengthen its chemicals management programs by improving access to and
the usefulness of chemical information. The goal is for people to
easily get information they need to make safe chemical choices and to
help businesses, individuals and others make more informed decisions
about the chemicals they use.
Benefits of this 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. Summary of Public Comments on the Proposed Rule
EPA received 35 unique public comments during the public comment
period for the proposed rule (89 FR 20918, March 26, 2024 (FRL-11164-
01-OCSPP)). Comments were submitted by citizens, industry groups and
companies, non-governmental organizations, and a state agency. The
public comments revealed varied perspectives across different types of
commenters.
Industry stakeholders were generally supportive of the need for
comprehensive chemical data under TSCA section 6. Some industry
commenters, however, expressed concerns about the utility of studies
involving low concentrations of chemicals or cases in which the
chemical is not the test substance (e.g., included in the study as an
impurity of the test substance or test mixture). Many such commenters
were not supportive of EPA lifting the impurity exemption and/or
requiring the submission of studies with the listed chemical substance
at any concentration or purity. Several industry commenters also
discussed the proposed OHTs requirement, with different points of view.
While some supported the use of templated and standardized submissions,
others expressed concerns about the administrative and financial
burdens of compliance, particularly with reporting on impurities. Some
industry stakeholders suggested extending the reporting deadlines from
90 to 180 days to allow more time for compliance. Finally, many
comments from companies or trade groups discussed EPA's draft burden
analysis, with many claiming that EPA had underestimated the time and
cost related to preparing and submitting OHTs.
Environmental groups and NGOs strongly supported the rule as
proposed, including the requirement to submit studies with the chemical
substances even when present as impurities. These commenters also
highlighted the importance of gathering data on 6PPD and its degradant,
6PPD-quinone, and urged EPA to finalize this rule quickly.
EPA considered all comments and information in the development of
this final rule. A comprehensive response to comments document can be
found in the docket (Ref. 2).
IV. 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. December
2024.
2. EPA. Response to Comments. TSCA Section 8(d) Certain Existing
Chemicals; Request to Submit Unpublished Health and Safety Data
Under TSCA. December 2024.
3. EPA. Supporting Statement under the Paperwork Reduction Act:
Section 8 of the Toxic Substances Control Act. EPA ICR No. 2703.01
OMB Control No. 2070-0224. November 2022.
V. 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)
As required by the PRA, 44 U.S.C. 3501 et seq., the information
collection activities associated with TSCA section 8(d) reporting are
approved by OMB under OMB Control No. 2070-0224. The Information
Collection Request (ICR) document that EPA prepared has been assigned
EPA ICR No. 2703.01 (Ref. 3). A copy of the approved ICR is in the
docket for this rule, and is briefly summarized here.
This action requires the reporting of unpublished health and safety
studies to EPA by manufacturers of certain chemical substances that are
being added to the Health and Safety Data Reporting Rule in 40 CFR part
716. EPA intends to use the information collected to assist in
assessing the chemical substances 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 section
[[Page 100761]]
14 and EPA's confidentiality regulations, 40 CFR part 2, subpart B.
Respondents/affected entities: Manufacturers (including importers)
of the 16 chemical substances identified in the rulemaking, see also
Unit I.A. and the ICR.
Respondent's obligation to respond: Mandatory, TSCA section 8(d)
(15 U.S.C. 2607(d)), and implementing regulations in 40 CFR part 716.
Estimated number of respondents: 160.
Frequency of response: One-time.
Total estimated burden: 23,962 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $2,011,604 (per year), with no annualized
capital or operation & maintenance costs. (Ref. 1)
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.
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 35 out
of 160 of the firms in the affected universe are small entities. Of
those small firms, 2 may experience an impact of above 1% and 1 may
have impacts above 3%. Details of this analysis are presented in
Chapter 6 of the Economic Analysis for this rule (Ref. 1), which can be
found in the docket.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million
(adjusted annually for inflation) or more (in 1995 dollars) as
described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or
uniquely affect small governments. The costs involved in this action
are estimated not to exceed $183 million in 2023$ ($100 million in
1995$ adjusted for inflation using the GDP implicit price deflator) or
more in any one year.
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. This rule affects entities who
manufacture (including import) chemical substances for commercial
purposes. 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 directly concern an environmental health
or safety risk to children, 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 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 subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards under the
NTTAA section 12(d), 15 U.S.C. 272.
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
The EPA believes that this type of action does not concern human
health or environmental conditions and therefore cannot be evaluated
with respect to potentially disproportionate and adverse effects on
communities with environmental justice concerns. 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 available for EPA's use under
TSCA section 6, thereby enabling the Agency to better protect human
health and the environment, including in low-income and minority
communities.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' under 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 716
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: December 10, 2024.
Michal Freedhoff,
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. 716.21 by adding paragraph (a)(11) to read as follows:
[[Page 100762]]
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. In Sec. 716.120, amend the table in paragraph (d) by:
0
a. Designating the table as table 3 to paragraph (d);
0
b. Adding the category sub-heading ``OPPT 2024 Chemicals:'' in
alphabetical order immediately preceding the category ``Organohalogen
flame retardants:''; and
0
c Adding the entries ``Acetaldehyde''; ``Acrylonitrile''; ``2-anilino-
5-[(4-methylpentan-2-yl)amino]cyclohexa-2,5-diene-1,4-dione (6PPD-
quinone)''; ``Benzenamine''; ``Benzene''; ``Bisphenol A'';
``Ethylbenzene''; ``Hydrogen fluoride''; ``4,4-Methylene bis(2-
chloraniline)''; ``N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine
(6PPD)''; ``Naphthalene''; ``Styrene''; ``4-tert-octylphenol(4-
(1,1,3,3-Tetramethylbutyl)-phenol)''; ``Tribomomethane (Bromoform)'';
``Triglycidyl isocyanurate''; and ``Vinyl Chloride'' after the category
sub-heading ``OPPT 2024 Chemicals:''.
The additions read as follows:
Sec. 716.120 Substances and listed mixtures to which this subpart
applies.
(d) * * *
Table 3 to Paragraph (d)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Category CAS No. Special exemptions Effective date Sunset date
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
OPPT 2024 Chemicals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaldehyde......................... 75-07-0 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
Acrylonitrile........................ 107-13-1 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
2-anilino-5-[(4-methylpentan-2- 2754428-18-5 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
yl)amino]cyclohexa-2,5-diene-1,4- Sec. 716.20(a)(9) does not
dione (6PPD-quinone). apply.
Benzenamine.......................... 62-53-3 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
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) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
Bisphenol A.......................... 80-05-7 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
Ethylbenzene......................... 100-41-4 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
Hydrogen fluoride.................... 7664-39-3 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
4,4-Methylene bis(2-chloraniline).... 101-14-4 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
N-(1,3-Dimethylbutyl)-N'-phenyl-p- 793-24-8 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
phenylenediamine (6PPD). Sec. 716.20(a)(9) does not
apply.
Naphthalene.......................... 91-20-3 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
Styrene.............................. 100-42-5 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
4-tert-octylphenol(4-(1,1,3,3- 140-66-9 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Tetramethylbutyl)-phenol). Sec. 716.20(a)(9) does not
apply.
Tribomomethane (Bromoform)........... 75-25-2 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
Triglycidyl isocyanurate............. 2451-62-9 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
Vinyl Chloride....................... 75-01-4 Sec. 716.21(a)(11) applies; January 13, 2025.................. March 13, 2025.
Sec. 716.20(a)(9) does not
apply.
[[Page 100763]]
* * * * * * *
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[FR Doc. 2024-29406 Filed 12-12-24; 8:45 am]
BILLING CODE 6560-50-P
