Initiation of Prioritization Under the Toxic Substances Control Act (TSCA); Request for Comment, 87423-87426 [2023-27641]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87423-87426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27641]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0601; FRL-11581-01-OCSPP]


Initiation of Prioritization Under the Toxic Substances Control 
Act (TSCA); Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
initiation of and soliciting public comment on the prioritization 
process for five chemical substances as candidates for designation as 
High-Priority Substances for risk evaluation under the Toxic Substances 
Control Act (TSCA) and related implementing regulations. This document 
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 that 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, 2024.

ADDRESSES: Submit your comments through https://www.regulations.gov. 
Follow the online instructions for submitting comments. Submit comments 
on the chemicals identified in Unit III.B. to the applicable chemical-
specific docket ID number provided in Unit III.B. Submit comments on 
the chemicals identified in Unit IV.B. and comments not related to a 
specific chemical, including general comments on Unit IV.A., to Docket 
ID No. EPA-HQ-OPPT-2023-0601. 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 contact: Sarah Au, Data Gathering and 
Analysis Division (7406M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-0398; 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?

    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, and members of the public. Since 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 the Toxic 
Substances Control Act (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 choose 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 
and low priority for risk evaluation. In December 2019, EPA designated 
20 High-Priority Substances pursuant to TSCA section 6(b)(2)(B), which 
are currently undergoing 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. By initiating this group of 
High-Priority Substance candidates, EPA intends to begin building 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 identifies the five chemical substances for which EPA 
is initiating the prioritization process, provides a general 
explanation of why

[[Page 87424]]

the Agency chose to initiate prioritization on these chemical 
substances, and provides a 90-day comment period for interested persons 
to submit relevant information. This document does not establish any 
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 of the information that 
you claim to be CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2 and/or 40 CFR part 703, as applicable.
2. Tips for Preparing Your Comments
    When preparing and submitting your comments, see the commenting 
tips at https://www.epa.gov/dockets/commenting-epa-dockets.html.

II. Background

    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, that 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, the Agency 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 or not 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.
    As described in 40 CFR 702.9(b) Information sources, 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 in our A Working Approach for 
Identifying Potential Candidate Chemicals for Prioritization (September 
27, 2018) and prioritization process (40 CFR 702.7), 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, 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/production/files/2018-09/documents/preprioritization_white_paper_9272018.pdf. To identify 
candidates for designation as High-Priority Substances, the Agency 
primarily looked to the TSCA Work Plan for Chemical Assessments: 2014 
Update (2014 TSCA Work Plan), available at https://www.epa.gov/sites/default/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf. TSCA requires the Agency to preferentially consider 
chemicals on the 2014 TSCA Work Plan, as these chemicals were selected 
due to their potential risk to human health and the environment. EPA 
also 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 notice 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. In order 
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 that the Agency has the 
information it needs to meet its statutory mandates.
    Using data sources such as those described in the document, A 
Working Approach for Identifying Potential Candidate Chemicals for 
Prioritization, EPA considered various types of information and data 
from existing databases (and dashboards) 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 information within 
the public and gray literature domains (e.g., searches in PubMed, Web 
of Science, other US government and international websites).
    Existing information from public and non-public (i.e., confidential 
business information) sources that are maintained by authoritative 
sources, such as other EPA program offices, state and federal agencies 
and various U.S. and international organizations are also considered 
(e.g., including but not

[[Page 87425]]

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 (Cal EPA), National Toxicology Program (NTP), 
National Institute for Occupational Safety and Health (NIOSH), Agency 
for Toxic Substances and Disease Registry (ATSDR), International Agency 
for Research on Cancer (IARC), European Chemicals Agency (ECHA), Health 
Canada and Organisation for Economic Co-operation and Development 
(OECD)).
    After identifying evidence of 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 existing risk assessments could be 
used to better understand the chemical substance's potential exposure 
and/or hazard characteristics.
    In the absence of measured data on chemicals being evaluated, EPA 
may use alternative means or new approach methods (NAMs) to obtain 
relevant data. These 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.
    To identify chemical substances, EPA considered information such as 
the data submitted to EPA in 2020 under the Chemical Data Reporting 
(CDR) rule under TSCA regarding reported uses and products as a 
surrogate for complexity of information to inform prioritization and 
risk evaluation. EPA considered the release and use information for 
these chemicals and screened them according to the types of industrial 
uses and types of products where the chemicals were used, as reported 
in the 2020 CDR.
    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, where 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 we publish the 
proposed priority designation.

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. Acetaldehyde, CAS RN 75-07-0, Docket ID No.: EPA-HQ-OPPT-2018-0497
    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. EPA also receives information annually 
on this chemical through the Toxics Release Inventory (TRI). 
Information is available from assessments conducted by the state of 
California, international organizations, and other countries.
2. Acrylonitrile, CAS RN 107-13-1, Docket ID No.: EPA-HQ-OPPT-2018-0449
    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. 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. Benzenamine, CAS RN 62-53-3, Docket ID No.: EPA-HQ-OPPT-2018-0474
    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. EPA also receives information annually 
on this chemical through the TRI. Information is available from 
assessments conducted by the Center for Disease Control (CDC), the 
state of California, international organizations, and other countries.
4. Vinyl Chloride, CAS RN 75-01-4, Docket ID No.: EPA-HQ-OPPT-2018-0448
    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. 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. 4,4'-Methylene bis(2-chloroaniline) (MBOCA), CAS RN 101-14-4, Docket 
ID No.: EPA-HQ-OPPT-2023-0464
    This chemical was listed in the 2014 TSCA Work Plan with a hazard 
score of 3; an exposure score of 2; and a persistence and 
bioaccumulation score of 2. 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 relevant to 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 requests 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

[[Page 87426]]

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.
    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 relevant to 10 additional chemical substances 
that EPA considered for the current round of prioritization?

    During the pre-prioritization process, EPA 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 15 chemical substances that 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 following chemical substances that are not 
currently undergoing prioritization by using Docket ID No. EPA-HQ-OPPT-
2023-0606.
     4-tert-Octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol), 
CAS RN 140-66-9;
     Benzene, CAS RN 71-43-2;
     Bisphenol A, CAS RN 80-05-7;
     Ethylbenzene, CAS RN 100-41-4;
     Napthalene, CAS RN 91-20-3;
     Styrene, CAS RN 100-42-5;
     Tribromomethane, CAS RN 75-25-2;
     Triglycidyl isocyanurate, CAS RN 2451-62-9;
     Hydrogen fluoride, CAS RN 7664-39-3; and
     N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine, CAS RN 
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, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2023-27641 Filed 12-15-23; 8:45 am]
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