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[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102903-102908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29829]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0601; FRL-11581-06-OCSPP]

Initiation of Prioritization Under the Toxic Substances Control 
Act (TSCA); Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Under the Toxic Substances Control Act (TSCA) and related 
implementing regulations, EPA is initiating the prioritization process 
for five chemical substances as candidates for designation as High-
Priority Substances for risk evaluation. This action provides the 
identity of the chemical substances being initiated for prioritization, 
a general explanation of why the Agency chose these chemical 
substances, and information on the data sources EPA plans to use to 
support the designation. EPA is providing a 90-day comment period, 
during which interested persons may submit relevant information on 
these chemical substances.

DATES: Comments must be received on or before March 18, 2025.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number, through https://www.regulations.gov. Follow the online 
instructions for submitting comments. For comments not related to a 
specific chemical, including general comments on Unit IV.A., use docket 
ID number EPA-HQ-OPPT-2023-0601; submit information on the candidates 
for which EPA is initiating the prioritization process to the 
applicable chemical-specific docket ID number identified in Unit 
III.B.; submit information on the potential candidates for which EPA is 
not currently initiating the prioritization

[[Page 102904]]

process to the docket ID number identified in Unit IV.B. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. Additional instructions on commenting or visiting the 
docket, along with more information about dockets generally, is 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information: Sarah Au, 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) 564-0398; email address: 
[email protected].
    For general information: 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?

    This action is directed to the public in general and may be of 
interest to entities that currently or may manufacture (including 
import) a chemical substance regulated under TSCA (e.g., entities 
identified under North American Industrial Classification System 
(NAICS) codes 325 and 324110). The action may also be of interest to 
chemical processors, distributors in commerce, users, non-profit 
organizations in the environmental and public health sectors, state and 
local government agencies, Tribes, and members of the public. Because 
other entities may also be interested, the Agency has not attempted to 
describe all the specific entities and corresponding NAICS codes for 
entities that may be interested in or affected by this action.

B. What action is the Agency taking?

    EPA is initiating the prioritization process under TSCA, 15 U.S.C. 
2601 et seq., for five chemical substances as candidates for 
designation as High-Priority Substances for risk evaluation. This 
document includes the identity of the chemical substances entering the 
prioritization process before designation and a general explanation of 
why the Agency chose to initiate prioritization on these chemical 
substances. In addition, EPA is providing a 90-day comment period 
during which interested persons may submit relevant information on 
these chemical substances. Relevant information might include, but is 
not limited to, any information that may inform the prioritization 
screening review conducted pursuant to 40 CFR 702.9(a).

C. Why is the Agency taking this action?

    TSCA section 6(b) requires that EPA initiate the prioritization 
process for chemical substances that may be designated as high priority 
or low priority for risk evaluation. Because EPA generally expects to 
complete five risk evaluations per year over the next several years, 
EPA is initiating the prioritization process for five chemical 
substances per TSCA section 6(b)(3)(C), which requires EPA to designate 
at least one High-Priority Substance upon completion of each risk 
evaluation for a High-Priority Substance. In the Federal Register on 
December 18, 2023 (88 FR 87423) (FRL-11581-01-OCSPP)), EPA initiated 
prioritization for five chemical substances that have undergone 
consideration as High-Priority Substances pursuant to TSCA section 
6(b)(2)(B). By initiating prioritization another five chemical 
substances pursuant to TSCA section 6(b)(2)(B), EPA intends to maintain 
a sustainable pipeline of existing chemical risk evaluations under TSCA 
section 6(b). The request for interested persons to submit relevant 
information on a chemical substance for which EPA has initiated the 
prioritization process is required by TSCA section 6(b)(1)(C)(i).

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

    This document is issued pursuant to the authority in TSCA section 
6(b)(1) and (3)(C).

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

    This document does not establish requirements on persons or 
entities outside of the Agency. No incremental impacts are therefore 
anticipated, and consequently EPA did not estimate potential 
incremental impacts for this action.

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

1. Submitting CBI
    Do not submit CBI to EPA through https://www.regulations.gov or 
email. If you wish to include CBI in your comment, please follow the 
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all the information you 
claim to be CBI. In addition to one complete version of the comment 
including information claimed as CBI, a copy of the comment that does 
not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2 and/or 40 CFR part 703, as applicable.
2. Tips for Preparing Your Comments
    When preparing and submitting your comments, see the commenting 
tips at https://www.epa.gov/dockets/commenting-epa-dockets.html.

II. Background

    TSCA section 6(b)(1) requires EPA to prioritize chemical substances 
for risk evaluation and to establish a process for prioritizing 
chemical substances. Under TSCA section 6(b) and as described in 40 CFR 
702.7, EPA is initiating the prioritization process for five chemical 
substances as candidates for High-Priority Substances for risk 
evaluation.
    Under TSCA section 6(b)(1)(B) and its implementing regulations (40 
CFR 702.3), a High-Priority Substance is defined as a chemical 
substance that EPA determines, without consideration of costs or other 
non-risk factors, may present an unreasonable risk of injury to health 
or the environment because of a potential hazard and a potential route 
of exposure under the conditions of use, including an unreasonable risk 
to potentially exposed or susceptible subpopulations identified as 
relevant by EPA.
    Initiation of prioritization for chemical substances as High-
Priority Substance candidates is not a finding of risk. Rather, when 
prioritization is complete, for those chemicals designated as High-
Priority Substances, EPA will have evidence that this substance may 
present an unreasonable risk of injury to health or the environment 
because of a potential hazard and a potential route of exposure under 
the conditions of use. Final designation of a High-Priority Substance 
initiates the risk evaluation process (40 CFR 702.17), which culminates 
in a finding of whether the chemical substance presents an unreasonable 
risk under the conditions of use.
    This document is intended to fulfill the TSCA section 6(b)(1)(C)(i) 
requirement that the Administrator request interested persons to submit 
relevant information on chemical substances for which the Administrator 
has initiated the prioritization process. As described in 40 CFR 702.7, 
this document initiates the prioritization process and provides 90 days 
during which interested persons may submit relevant information.

[[Page 102905]]

    As described in 40 CFR 702.9(b), in conducting the screening review 
during the prioritization process, EPA will consider sources of 
information relevant to the screening review criteria as outlined in 
the statute (TSCA section 6(b)(1)(A)) and implementing regulations (40 
CFR 702.9(a)) and consistent with the scientific standards of TSCA 
section 26(h), including, as appropriate, sources for hazard and 
exposure data listed in Appendices A and B of the TSCA Work Plan 
Chemicals: Methods Document (February 2012).
    Consistent with the approach described in 40 CFR 702.7, and the ``A 
Working Approach for Identifying Potential Candidate Chemicals for 
Prioritization'' document (September 27, 2018), available at https://www.epa.gov/sites/default/files/2018-09/documents/preprioritization_white_paper_9272018.pdf, EPA consulted with other 
federal agencies and intends to continue to collaborate with them to 
identify information that is useful throughout the prioritization 
process.

III. High Priority Candidate Chemical Substances for Which EPA Is 
Initiating Prioritization

A. How did EPA select these candidates for prioritization for potential 
designation as High-Priority Substances for risk evaluation?

    In general, EPA's working approach to select candidates for 
designation as High-Priority Substances for risk evaluation is outlined 
in the document, titled ``A Working Approach for Identifying Potential 
Candidate Chemicals for Prioritization,'' released to the public on 
September 27, 2018, available at https://www.epa.gov/sites/default/files/2018-09/documents/preprioritization_white_paper_9272018.pdf. To 
identify candidates for designation as High-Priority Substances, EPA 
primarily reviewed the ``TSCA Work Plan for Chemical Assessments: 2014 
Update (2014 TSCA Work Plan),'' available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-assessments-2014-update. TSCA requires EPA to preferentially consider 
chemicals on the 2014 TSCA Work Plan that are persistent and 
bioaccumulative and those that are known human carcinogens and highly 
toxic, based on scores and criteria documented in the Work Plan, as 
these chemicals were selected for inclusion on the Work Plan due to 
their potential risk to human health and the environment. Aside from 
this statutory requirement, TSCA gives EPA discretion in how the Agency 
ultimately selects a chemical substance for prioritization. EPA strives 
to designate as High-Priority Substances those chemicals with the 
greatest hazard and exposure potential first, consistent with the 
policy objectives codified in 40 CFR 702.5(a) in the Federal Register 
on July 20, 2017 (82 FR 33753) (FRL-9964-24)).
    The number of chemical substances remaining on the 2014 TSCA Work 
Plan with persistence and bioaccumulation scores of 3 has been 
significantly reduced over time as EPA has expedited rulemaking under 
TSCA section 6(h) for five persistent, bioaccumulative, and toxic (PBT) 
chemical substances and as the Agency has conducted risk evaluations 
and promulgated risk management for rules for other chemical substances 
from the 2014 TSCA Work Plan. TSCA section 6(b)(2)(B) further requires 
that at least 50 percent of all ongoing risk evaluations be drawn from 
the 2014 TSCA Work Plan for Chemical Assessments. Given EPA's statutory 
deadlines and the timing of prioritization actions needed to offset the 
completion of risk evaluations for chemical substances designated as 
High-Priority Substances in 2019, EPA heavily weighed data availability 
in deciding which chemical substances to include in this action. 
Chemical substances remaining on the 2014 TSCA Work Plan that have 
persistence and bioaccumulation scores of 3 have significant data gaps, 
were submitted as potential manufacturer-requested risk evaluation 
candidates or are categories for which EPA is in the process of 
determining specific chemical structures that may be considered for 
inclusion in those categories.
    EPA consulted with other EPA program offices and partner federal 
agencies to inform the Agency's prioritization efforts. With these 
considerations, the chemicals for which prioritization is initiated in 
this action were selected based on a variety of factors and reflect 
Agency priorities. While data availability was a significant driver of 
the Agency's selections, EPA also considered the complexity of 
evaluating broad chemical categories such as metal compounds. For EPA 
to build a sustainable TSCA prioritization, evaluation, and (when 
appropriate) risk management pipeline, chemicals ultimately designated 
as High-Priority Substances for risk evaluation should have a robust 
data landscape. In future rounds of prioritization, EPA intends to use 
its data gathering authorities earlier and commits to regular 
stakeholder engagement to ensure the Agency has the information needed 
to meet its statutory mandates.
    Using data sources such as those described in the document titled, 
``A Working Approach for Identifying Potential Candidate Chemicals for 
Prioritization,'' EPA considered various types of information and data 
from existing resources such as EPA's National Center for Computational 
Toxicology's Chemistry Dashboard (CompTox Chemicals Dashboard), 
available at https://comptox.epa.gov/dashboard. EPA also conducted 
initial searches of additional sources of public and gray literature 
(e.g., PubMed, Web of Science, other U.S. government and international 
websites).
    EPA also considered existing information from public and non-public 
(i.e., confidential business information) sources maintained by 
authoritative sources, such as other EPA program offices, state and 
federal agencies, and various U.S. and international organizations 
(including but not limited to EPA's Office of Water, EPA's Office of 
Air and Radiation, EPA's Office of Research and Development, California 
Environmental Protection Agency, National Institute for Occupational 
Safety and Health, Agency for Toxic Substances and Disease Registry, 
European Chemicals Agency, Health Canada, International Agency for 
Research on Cancer, and Organisation for Economic Co-operation and 
Development).
    After identifying information from reasonably available sources, 
the information was screened across several data elements including 
physical and chemical properties, environmental fate and transport 
properties, hazard, exposure, and use information to determine the 
breadth of data availability for a chemical substance. Using experience 
gained from TSCA implementation activities to date, EPA considered 
previous and planned Agency activities related to a given chemical 
substance, including how to better leverage experience gained from 
previously conducted or ongoing risk evaluations. EPA also considered 
whether analyses from previous risk assessments could be used to better 
understand each chemical substance's potential exposure and/or hazard 
characteristics.
    In the absence of measured empirical data on chemicals being 
evaluated, EPA may use alternative means or new approach methods (NAMs) 
to obtain relevant data. NAMs can reduce vertebrate testing, consistent 
with TSCA section 4(h)(1)(A). EPA intends to use this approach to the 
extent practicable and scientifically justified.
    EPA also considered information such as data submitted to EPA in 
2020 under

[[Page 102906]]

the Chemical Data Reporting (CDR) rule under TSCA regarding reported 
uses and products to inform prioritization and risk evaluation. EPA 
considered the use information for these chemicals and screened them 
according to the types of industrial uses and types of products for 
which the chemicals were used as reported in the 2020 CDR. Information 
reported to the Toxics Release Inventory Program was also considered to 
identify reported uses and releases of chemical substances.
    EPA intends to update and refine its initial review based on data 
sources identified by the public during the comment period (see EPA's 
request for data in Unit IV.) and, as permitted by TSCA section 14 and 
subject to EPA confidentiality regulations at 40 CFR part 2, subpart B 
and 40 CFR part 703, intends to make this information publicly 
available for the initiated chemicals when EPA publishes the proposed 
priority designation.
    Between December 18, 2023, and October 31, 2024, EPA received 
information regarding candidate chemical substances being considered 
for prioritization actions during two periods. During September and 
October 2023, EPA hosted a series of pre-prioritization meetings with 
various stakeholders, Tribes, state and local governments, and other 
federal agencies to explain the prioritization process and provide an 
overview of information that may be used to inform the considerations 
that ultimately support a High- or Low-Priority Substance designation. 
A list of 15 candidate chemical substances being considered for future 
prioritization actions, including those undergoing initiation in this 
prioritization action, was presented to provide an opportunity for 
partners, stakeholders, and any interested persons to comment on the 
data and scientific literature available that may be used to help EPA 
determine which chemical substances may undergo prioritization in the 
near term. EPA also opened docket ID No. EPA-HQ-OPPT-2023-0606 for 90 
days to receive any potentially relevant information on the 10 chemical 
substances communicated as candidates for prioritization but not 
selected for initiation on December 18, 2023, which included the 
chemical substances for which prioritization is being initiated with 
this action.
    As a part of EPA's commitment to greater transparency and to 
maintain engagement with partners, stakeholders or any interested 
persons about upcoming prioritization actions, EPA hosted public 
webinars on September 30 and October 1, 2024, that explained the 
prioritization process, provided an overview of information that may be 
used to inform the considerations that ultimately support a High- or 
Low-Priority Substance designation, and shared an expanded list of 27 
candidate chemical substances being considered for prioritization 
actions. This expanded list included the 10 chemical substances 
previously communicated in 2023 as being potential candidates for 
prioritization but not yet selected for initiation. Following the 
public webinars, EPA opened docket ID No. EPA-HQ-OPPT-2023-0606 for 30 
days to receive any potentially relevant information on the 27 chemical 
substances communicated as being candidates for prioritization. EPA 
also engaged with Tribes, state and local governments, and other 
federal agencies and presented the same information that was provided 
during the public webinars.
    EPA considered all comments and information received during the 
various meetings and webinars, as well as those submitted to docket ID 
no. EPA-HQ-OPPT-2023-0606 on all candidate chemical substances 
considered for prioritization actions communicated between September 
2023 and October 2024 to identify the five chemical substances being 
initiated for prioritization. During the first 90-day public comment 
period accompanying the initiation action that began in December 2023, 
EPA received comments pertaining to six chemical substances 
communicated as potential candidates for prioritization during the pre-
prioritization presentations in September and October 2023 and 
September and October 2024: 4-tert- octylphenol, N-(1,3-Dimethylbutyl)-
N'-phenyl-p-phenylenediamine (6PPD), benzene, ethylbenzene, 
naphthalene, and styrene.
    One commentor (EPA-HQ-OPPT-2018-0448-0027) wrote in general support 
of the consideration of benzene, ethylbenzene, naphthalene, and styrene 
for upcoming prioritization actions and the consideration of submitted 
information on natural disasters and environmental impacts on potential 
exposure.
    Some commenters (EPA-HQ-OPPT-2023-0606-0005; EPA-HQ-OPPT-2023-0606-
0006; EPA-HQ-OPPT-2023-0606-0007) included information on 6PPD and/or 
6PPD-quinone (a degradation product of 6PPD) for consideration in 
upcoming prioritization actions and in support of the petition 
submitted under TSCA section 21 requesting the promulgation of risk 
management regulations under TSCA section 6(a) to prohibit the 
manufacturing, processing, use and distribution of 6PPD for and in 
tires to eliminate unreasonable risk to the environment.
    Another commenter (EPA-HQ-OPPT-2023-0606-0005) requested that 
docket ID. No. EPA-HQ-OPPT-2023-0606 remain open to allow for 
continuous submission of potentially relevant information regarding the 
characterization of 6PPD risk. EPA intends to re-open docket ID No. 
EPA-HQ-OPPT-2023-0606 during specific timeframes during pre-
prioritization to allow for submission of information using 
regulations.gov.
    As described in Unit IV.B., EPA is also re-opening docket ID No. 
EPA-HQ-OPPT-2023-0606 to solicit comments and information on 22 
chemical substances that are candidates for future prioritization 
actions. Regarding the TSCA section 21 petition from Earthjustice on 
behalf of the Yurok Tribe, the Port Gamble S'Klallam Tribe, and the 
Puyallup Tribe of Indians, EPA issued an Advance Notice of Proposed 
Rulemaking in the Federal Register on November 18, 2024 (89 FR 91299) 
(FRL-11682-01-OCSPP)) for 6PPD and 6PPD-quinone under TSCA section 
6(a), and is committed to finalizing a TSCA section 8(d) rulemaking by 
the end of 2024 that would require persons who manufacture (including 
import) 6PPD to submit lists or copies of unpublished health and safety 
studies to EPA.
    One commentor (EPA-HQ-OPPT-2023-0606-0003) stated that the 
information presented in the 2014 TSCA Work Plan was incorrect for 4-
tert-octylphenol and that EPA should not include 4-tert-octylphenol on 
the fourth Candidate Chemical List under SDWA. Under TSCA, EPA is 
required to consider chemical substances identified in the 2014 TSCA 
Work Plan and does not plan to revise the Work Plan as part of this 
action. Additional information received regarding the potential hazard, 
potential exposure, and bioaccumulation and persistence of 4-tert-
octylphenol may be considered during prioritization.
    For more information on the comments and EPA's responses regarding 
the candidate chemical substances, see Section 1.7 and 7.1 of the ``EPA 
Response to Public Comments Received on the ``Initiation of 
Prioritization Under the Toxic Substances Control Act'' and ``Proposed 
High-Priority Substance Designations Under the Toxic Substances Control 
Act'' document published in docket ID no. EPA-HQ-OPPT-2023-0601 and 
EPA-HQ-OPPT-2023-0606.

[[Page 102907]]

B. What chemicals are being initiated?

    EPA is initiating the prioritization process for the following five 
chemicals as candidates for designation as High-Priority Substances:
1. 4-Tert-Octylphenol, CASRN 140-66-9, Docket ID No.: EPA-HQ-OPPT-2018-
0496
    This chemical was listed in the 2014 TSCA Work Plan with a hazard 
score of 3; an exposure score of 3; and a persistence and 
bioaccumulation score of 2. Exposure to 4-tert-octyphenol (4-(1,1,3,3-
tetramethylbutyl)-phenol may result in a range of human health effects 
such as kidney inflammation and impaired fertility (i.e., lowered sperm 
count). Data related to human carcinogenicity have not been identified. 
Data regarding the use of this chemical was reported to EPA in the 2020 
CDR. EPA also receives information annually on this chemical through 
the Toxics Release Inventory (TRI). Information is available from 
assessments conducted by international organizations, and other 
countries.
2. Benzene, CASRN 71-43-2, Docket ID No.: EPA-HQ-OPPT-2018-0475
    This chemical was listed in the 2014 TSCA Work Plan with a hazard 
score of 3; an exposure score of 3; and a persistence and 
bioaccumulation score of 1. Data regarding the use of this chemical was 
reported to EPA in the 2020 CDR. Benzene is a known human carcinogen. 
Exposure to benzene may also result in a range of health effects such 
as immune function (e.g., decreased immune lymphocyte count) and 
developmental abnormalities (i.e., fetal malformations). EPA also 
receives information annually on this chemical through the TRI. 
Information is available from assessments conducted by other federal 
agencies, the state of California, international organizations, and 
other countries.
3. Ethylbenzene, CAS RN 100-41-4, Docket ID No.: EPA-HQ-OPPT-2018-0487
    This chemical was listed in the 2014 TSCA Work Plan with a hazard 
score of 3; an exposure score of 3; and a persistence and 
bioaccumulation score of 1. Ethylbenzene is a probable human 
carcinogen. Exposure to ethylbenzene may also result in a range of 
health effects such as changes to liver and kidney tissue, hearing 
loss, and developmental abnormalities (i.e., fetal malformations). Data 
regarding the use of this chemical was reported to EPA in the 2020 CDR. 
EPA also receives information annually on this chemical through the 
TRI. Information is available from assessments conducted by other 
federal agencies, the state of California, international organizations, 
and other countries.
4. Naphthalene, CASRN 91-20-3, Docket ID No.: EPA-HQ-OPPT-2018-0454
    This chemical was listed in the 2014 TSCA Work Plan with a hazard 
score of 3; an exposure score of 3; and a persistence and 
bioaccumulation score of 2. Naphthalene is a probable human carcinogen. 
Exposure to naphthalene may also result in a range of health effects 
such as destruction of red blood cells resulting in lower blood oxygen, 
damage to eyesight, and changes to liver, lung, and nasal tissue. Data 
regarding the use of this chemical was reported to EPA in the 2020 CDR. 
EPA also receives information annually on this chemical through the 
TRI. Information is available from assessments conducted by other 
federal agencies, the state of California, international organizations, 
and other countries.
5. Styrene, CASRN 100-42-5, Docket ID No.: EPA-HQ-OPPT-2018-0461
    This chemical was listed in the 2014 TSCA Work Plan with a hazard 
score of 3; an exposure score of 3; and a persistence and 
bioaccumulation score of 1. Styrene is a probable human carcinogen. 
Exposure to styrene may also result in a range of health effects such 
as hearing loss, memory loss, fetal death, and tissue changes in the 
lungs and nasal passages. Data regarding the use of this chemical was 
reported to EPA in the 2020 CDR. EPA also receives information annually 
on this chemical through the TRI. Information is available from 
assessments conducted by other federal agencies, the state of 
California, international organizations, and other countries.

IV. Relevant Information

A. What additional information is EPA seeking for the five candidate 
chemical substances for which EPA is initiating prioritization?

    Through this initiation of prioritization for chemical substances, 
EPA is providing a 90-day comment period as required by the statute 
(TSCA section 6(b)(1)(C)(i)) and implementing regulations (40 CFR 
702.7(d)) and requesting that interested persons voluntarily submit 
relevant information. Relevant information might include, but is not 
limited to, information that may inform the screening review conducted 
pursuant to 40 CFR 702.9(a), consistent with the scientific standard of 
TSCA section 26(h), about the following criteria and considerations:
     The chemical substance's hazard and exposure potential;
     The chemical substance's persistence and bioaccumulation;
     Potentially exposed or susceptible subpopulations which 
the submitter believes are relevant to the prioritization;
     Whether there is any storage of the chemical substance 
near significant sources of drinking water, including the storage 
facility location and the nearby drinking water source(s);
     The chemical substance's conditions of use or significant 
changes in conditions of use, including information regarding trade 
names;
     The chemical substance's production volume or significant 
changes in production volume; and
     Any other information relevant to the potential risks of 
the chemical substance that might be relevant to the designation of the 
chemical substance's priority for risk evaluation.
    If the information is publicly available, citations are sufficient 
(including, but not limited to: Title, author, date of publication, 
publication source), and the submission does not need to include copies 
of the information.

B. What information is the Agency seeking for the 22 additional 
chemical substances that EPA considered, but did not select, for the 
current round of prioritization?

    During the pre-prioritization process, EPA hosted public webinars 
and met with federal partners, industry, environmental organizations, 
labor organizations, state and local governments, and Tribes to discuss 
the prioritization process and presented a list of 27 chemical 
substances EPA was considering for prioritization. EPA took feedback 
from these discussions into consideration when selecting the five 
chemicals for prioritization listed in Unit III.B. Interested persons 
may submit relevant information on the chemical substances listed in 
this unit that are not currently undergoing prioritization by using 
docket ID number EPA-HQ-OPPT-2023-0606.
    EPA has not yet determined which specific chemical structures are 
being considered for the chemical substances designated as a category 
in the 2014 TSCA Work Plan (i.e., do not have CASRN listed). Therefore, 
EPA welcomes comments and information on specific chemical structures 
that may be relevant for addressing the various prioritization criteria 
and considerations on the chemical categories listed in this

[[Page 102908]]

unit. Information submitted on the substances within a category should 
be reported for each individual chemical structure, to the extent 
possible (i.e., known or reasonably ascertainable). If the chemical 
identity of some of the individual chemical structures are not known or 
reasonably ascertainable by the commenter, the information associated 
with those chemical substances may be reported as a group of chemical 
structures (i.e., isomeric mixture) or as the chemical category:
     1-Hexadecanol, CASRN 36653-82-4;
     2-Ethylhexyl 2,3,4,5-tetrabromobenzoate (TBB), CASRN 
183658-27-7;
     Bis(2-Ethylhexyl)-3,4,5,6-Tetrabromophthalate (TBPH), 
CASRN 26040-51-7;
     Bisphenol A, CASRN 80-05-7;
     Creosote, CASRN 8001-58-9;
     Di-n-octyl phthalate (DnOP), CASRN 117-84-0;
     N-Nitroso-diphenylamine, CASRN 86-30-6;
     P,P'-Oxybis(benzenesulfonylhydrazide), CASRN 80-51-3;
     Tribromomethane, CASRN 75-25-2;
     Triglycidyl isocyanurate, CASRN 2451-62-9;
     M-Xylene, CASRN 108-38-3;
     O-Xylene, CASRN 95-47-6;
     P-Xylene, CASRN 106-42-3;
     Antimony and Antimony Compounds, Category;
     Arsenic and Arsenic Compounds, Category;
     Cobalt and Cobalt Compounds, Category;
     Lead and Lead Compounds, Category;
     Long-chain chlorinated paraffins (C18-20), Category;
     Medium-chain chlorinated paraffins (C14-17), Category;
     Bisphenol S, CASRN 80-09-1;
     Hydrogen Fluoride, CASRN 7664-39-3;
     N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD), 
CASRN 793-24-8.

C. How will confidential business information be protected?

    A person seeking to protect from disclosure as ``confidential 
business information'' any information that person submits under TSCA 
must assert and substantiate a claim for protection from disclosure 
concurrent with submission of the information in accordance with the 
requirements of TSCA section 14 and 40 CFR 703, with limited exceptions 
provided in the statute. TSCA section 14(b) limits confidentiality 
protections for health and safety studies and information from such 
studies, however, and while EPA considers confidential business 
information when conducting its review under 40 CFR 702.9(a), the 
Agency encourages submitters to minimize claims for protection from 
disclosure wherever possible to maximize transparency in EPA's 
screening review. More information on asserting and submitting 
confidential business information claims under TSCA can be found at 40 
CFR 703 and https://www.epa.gov/tsca-cbi.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: December 12, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-29829 Filed 12-17-24; 8:45 am]
BILLING CODE 6560-50-P
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