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[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]

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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Certain Existing Chemicals; Request To Submit Unpublished Health 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.

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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rulemaking to submit copies and lists of certain unpublished health and 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

[[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 [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

[[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]]

 
 
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[FR Doc. 2024-29406 Filed 12-12-24; 8:45 am]
BILLING CODE 6560-50-P
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