[Federal Register Volume 90, Number 10 (Thursday, January 16, 2025)]
[Notices]
[Pages 4738-4740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00948]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0448; FRL-12439-01-OCSPP]
Vinyl Chloride; Draft Scope of the Risk Evaluation Under the
Toxic Substances Control Act (TSCA); Notice of Availability and Request
for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
announcing the availability of and seeking public comment on the draft
scope of the risk evaluation to be conducted under the Toxic Substances
Control Act (TSCA) for vinyl chloride (ethene, chloro-; CASRN 75-01-4).
Under TSCA, the scope documents must include the conditions of use,
hazards, exposures, and the potentially exposed or susceptible
subpopulations that EPA expects to consider in conducting the risk
evaluation for this chemical substance. The purpose of risk evaluations
under TSCA is to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment under the
conditions of use, including unreasonable risk to potentially exposed
or susceptible subpopulations identified as relevant to the risk
evaluation by EPA, and without consideration of costs or non-risk
factors.
DATES: Comments must be received on or before March 3, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0448, online at https://www.regulations.gov. Follow the online instructions for submitting
comments. 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 and 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: Marcy Card, Existing Chemicals Risk
Assessment Division (7403M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-1202; 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
particular interest to those involved in the manufacture (defined under
TSCA section 3(9) to include import), processing, distribution, use,
and disposal of vinyl chloride, related industry trade organizations,
non-governmental organizations with an interest in human and
environmental health, state and local governments, Tribal Nations, and/
or those interested in the assessment of risks involving chemical
substances and mixtures regulated under TSCA. As such, the Agency has
not attempted to describe all the specific entities that this action
might apply to. If you need help determining applicability, consult the
technical contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
The draft scope of the risk evaluation is issued pursuant to TSCA
section 6(b)(4)(D), 15 U.S.C. 2605(b)(4)(D), and EPA's implementing
regulations at 40 CFR 702.39(b).
C. What action is the Agency taking?
EPA is announcing the availability of and seeking public comment on
the draft scope of the risk evaluation to be conducted under TSCA for
vinyl chloride (ethene, chloro-; CASRN 75-01-4). Under TSCA, the scope
documents must include the conditions of use, hazards, exposures, and
the potentially exposed or susceptible subpopulations that EPA expects
to consider in conducting the risk evaluation for this chemical
substance. The purpose of risk evaluations under TSCA is to determine
whether a chemical substance presents an unreasonable risk of injury to
health or the environment under the conditions of use, including
unreasonable risk to potentially exposed or susceptible subpopulations
identified as relevant to the risk evaluation by EPA, and without
consideration of costs or non-risk factors.
D. What should I consider as I prepare my comments?
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
information that you claim to be CBI. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR
parts 2 and 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.
II. Background
A. What is vinyl chloride?
Vinyl chloride (ethene, chloro-), also known as chloroethylene, is
a chlorinated ethene that does not occur naturally in the environment.
Its primary use is as a reactant (monomer) in the production of
polyvinyl chloride (PVC) in consumer, commercial, and industrial
applications. Since 1986, the national aggregate production volume of
vinyl chloride, as reported under the Chemical Data Reporting (CDR)
rule, formerly known as the Inventory Update Rule (IUR) (40 CFR part
711), has been consistently over 1 billion pounds. In 2011, over 16
billion pounds were reported to CDR and since 2012 production volume
has been reported between 10 billion and 20 billion pounds.
Due to its physical state as a gas at room temperature and
pressure, vinyl chloride is expected to be primarily present in the
atmosphere in vapor phase and is not expected to partition to airborne
particles. Exposure to vinyl chloride may result in a range of harmful
health effects such as liver toxicity, neurotoxicity, immunotoxicity,
and developmental toxicity. EPA previous determined that vinyl chloride
is a ``known human carcinogen.''
B. Draft Scope for the Risk Evaluation of Vinyl Chloride
In December 2024, EPA announced its designation of vinyl chloride
as a high priority substance for risk evaluation under TSCA (Ref. 1),
which initiated the risk evaluation phase and started the 3 to 3.5 year
statutory timeframe in which the risk evaluation is to be completed.
The draft scope of the risk evaluation for this chemical substance
(Ref. 2) includes the conditions of use, hazards, exposures, and the
potentially exposed or susceptible subpopulations EPA expects to
consider in the risk evaluation (15 U.S.C. 2605(b)(4)(D)). Development
of the scope is the first step of a risk evaluation, and includes the
following components (40 CFR 702.39(b)):
The conditions of use, as determined by the Administrator,
that EPA expects to consider in the risk evaluation;
The potentially exposed populations, including any
potentially exposed or susceptible subpopulations identified as
relevant to the risk evaluation by EPA under the conditions of use that
EPA expects to evaluate;
The ecological receptors that EPA expects to evaluate;
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The hazards to health and the environment that EPA expects
to evaluate;
A description of the reasonably available information and
the science approaches that the Agency expects to use;
A conceptual model that describes the actual or predicted
relationships between the chemical substance, its associated conditions
of use through predicted exposure scenarios, and the identified human
and environmental receptors and human and ecological health hazards;
An analysis plan that describes how EPA intends to assess
hazards and exposures, and characterize risks; and
A plan for peer review.
III. Request for Comment
EPA seeks feedback on the approaches presented in the draft scope
of the risk evaluation, use profile (Ref. 3), and draft chemistry and
fate technical support document (Ref. 4), copies of which are available
in the docket. EPA encourages commenters to provide information they
believe might be missing or may further inform the risk evaluation. To
the extent possible, the Agency asks commenters to please cite any
public data related to or that supports the comments provided, and, to
the extent permissible, describe any supporting data that is not
publicly available.
IV. Next Steps
EPA will consider comments received and prepare the final scope of
the risk evaluation for vinyl chloride. EPA intends to publish a notice
in the Federal Register announcing the availability of the final scope
of the risk evaluation within six months of the designation of vinyl
chloride as a high-priority substance for risk evaluation under TSCA
(Ref. 1), i.e., by June 2025.
For more information about the TSCA risk evaluation process for
existing chemicals, go to https://www.epa.gov/assessing-and-managing-
chemicals-under-tsca.
V. 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, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. High-Priority Substance Designations Under the Toxic
Substances Control Act (TSCA) and Initiation of Risk Evaluation on
High-Priority Substances; Notice of Availability. Federal Register.
89 FR 102900, December 18, 2024 (FRL-11581-07-OCSPP)
2. EPA. Vinyl Chloride; Draft Scope of the Risk Evaluation under
the Toxic Substances Control Act (TSCA). January 2025.
3. EPA. Use Report for Vinyl Chloride. January 2025.
4. EPA. Draft Chemistry and Fate Technical Support Document for
Vinyl Chloride, January 2025.
Authority: 15 U.S.C. 2601 et seq.
Dated: January 10, 2025.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2025-00948 Filed 1-15-25; 8:45 am]
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