[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Certain Existing Chemicals; Request To Submit Unpublished Health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rulemaking to submit copies and lists of certain unpublished health and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: 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.
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
[[Page 100758]]
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
[[Page 100759]]
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 tsca-hotline@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 ``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
[[Page 100760]]
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]]
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
[FR Doc. 2024-29406 Filed 12-12-24; 8:45 am]
BILLING CODE 6560-50-P