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[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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[[Page 4739]]

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;

[[Page 4740]]

     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]
BILLING CODE 6560-50-P
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