[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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