Notice2025-20240
1,2-Dichloroethane; Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment
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Published
November 19, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is announcing the availability of and seeking public comment on a draft risk evaluation under the Toxic Substances Control Act (TSCA) for 1,2- dichloroethane (CASRN 107-06-2). 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 (COUs), 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. EPA used the best available science to prepare this draft risk evaluation and to preliminarily determine, based on the weight of scientific evidence, that 1,2-dichloroethane poses unreasonable risk to human health and the environment driven primarily by certain COUs analyzed in the draft risk evaluation.
Full Text
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<title>Federal Register, Volume 90 Issue 221 (Wednesday, November 19, 2025)</title>
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[Federal Register Volume 90, Number 221 (Wednesday, November 19, 2025)]
[Notices]
[Pages 52054-52056]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20240]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0427]; FRL-11809-06-OCSPP]
1,2-Dichloroethane; Draft 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 a draft
risk evaluation under the Toxic Substances Control Act (TSCA) for 1,2-
dichloroethane (CASRN 107-06-2). 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 (COUs), 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. EPA used the best available science to prepare this draft risk
evaluation and to preliminarily determine, based on the weight of
scientific evidence, that 1,2-dichloroethane poses unreasonable risk to
human health and the environment driven primarily by certain COUs
analyzed in the draft risk evaluation.
DATES: Comments must be received on or before January 20, 2026.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0427, online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: Seema Schappelle, Existing Chemical Risk
Assessment Division, Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-8006; email address:
<a href="/cdn-cgi/l/email-protection#75445b475b311c161d191a071a10011d141b105b21263634351005145b121a03"><span class="__cf_email__" data-cfemail="bf8e918d91fbd6dcd7d3d0cdd0dacbd7ded1da91ebecfcfeffdacfde91d8d0c9">[email protected]</span></a>.
For general information: The TSCA-Hotline, Goodwill of the Finger
Lakes, 422 South Clinton Ave., Rochester, NY 14620; telephone number:
(202) 554-1404; email address: <a href="/cdn-cgi/l/email-protection#0551564644284d6a71696c6b60456075642b626a73"><span class="__cf_email__" data-cfemail="01555242402c496e756d686f64416471602f666e77">[email protected]</span></a>.
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 1,2-dichloroethane, 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 Agency is conducting this risk evaluation under TSCA section 6,
15 U.S.C. 2605, which requires that EPA conduct risk evaluations on
chemical substances and identifies the minimum components EPA must
include in the risk evaluations. Each risk evaluation must be conducted
consistent with the best available science, be based on the weight of
scientific evidence, consider reasonably available information, and not
consider costs or non-risk factors. 15 U.S.C. 2625(h), (i), and (k).
See also the implementing procedural regulations at 40 CFR part 702.
C. What action is the Agency taking?
EPA is announcing the availability of and seeking public comment on
a draft risk evaluation under TSCA for 1,2-dichloroethane. 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 COUs, 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. EPA has used the best available science to prepare this draft
risk evaluation and, based on the weight of scientific evidence, to
preliminarily
[[Page 52055]]
determine that 1,2-dichloroethane presents unreasonable risk to human
health and the environment driven primarily by certain COUs analyzed in
the draft risk evaluation.
D. What should I consider as I prepare my comments?
1. Submitting CBI. Do not submit CBI to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you wish to include CBI in your
comment, please follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> 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 <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
A. What is 1,2-Dichloroethane?
1,2-Dichloroethane, also known as ethylene dichloride or EDC (CASRN
107-06-2), is a volatile, colorless, oily liquid with a chloroform-like
odor that is used primarily in the synthesis of vinyl chloride; over 90
percent of 1,2-dichloroethane is manufactured to be converted to vinyl
chloride. It is soluble in water (8,600 mg/L) and is miscible in most
organic solvents. Between 2016 and 2019, production volume of 1,2-
dichloroethane was reported to be between 30 to 40 billion pounds,
based on the 2020 TSCA Chemical Data Reporting data.
B. Summary of Activities for the Risk Evaluation of 1,2-Dichloroethane
In December 2019, EPA announced its designation of 1,2-
dichloroethane as a high priority substance for risk evaluation under
TSCA (Ref. 1). In April 2020, EPA sought public comment on the draft
scope of the 1,2-dichloroethane risk evaluation (Ref. 2), and after
considering public comments, issued the final scope in September 2020
(Ref. 3). In July 2024, EPA released the Draft Human Health Hazard
Assessment for 1,2-Dichloroethane for public comment and external peer
review by the Science Advisory Committee on Chemicals (SACC) (Ref. 4).
As part of the SACC deliberations, the Agency held a virtual public
meeting to discuss the Draft Risk Evaluation for 1,1-Dichloroethane as
well as the Draft Human Health Hazard Assessment for 1,2-Dichloroethane
in September 2024. For more information about this meeting, go to the
SACC website at <a href="https://www.epa.gov/tsca-peer-review/science-advisory-committee-chemicals-meetings">https://www.epa.gov/tsca-peer-review/science-advisory-committee-chemicals-meetings</a>. In June 2025, EPA released a response to
comments document titled, ``Summary of and Response to External Peer
Review and Public Comments on the Risk Evaluation for 1,1-
Dichloroethane and Human Health Hazard Technical Support Document for
1,2-Dichloroethane'' (Ref 5). These documents, other supporting
documents, and public comments are in dockets EPA-HQ-OPPT-2018-0427 and
EPA-HQ-OPPT-2024-0114. The draft risk evaluation for 1,2-dichloroethane
is being released with this notice.
Due to prior review, EPA is not soliciting additional peer review
of the human health hazard assessment. Additional external peer review
is also not needed on the other components of the draft risk evaluation
because (1) the Draft Human Health Hazard Assessment for 1,2-
Dichloroethane was peer reviewed by the SACC (Ref. 4); and (2) the
methodologies used in the development of the 1,2-dichloroethane draft
risk evaluation have been previously peer reviewed by the SACC in
published risk evaluations for 1,1-dichloroethane (Ref. 5), carbon
tetrachloride (Ref. 6), methylene chloride (Ref. 7), perchloroethylene
(Ref. 8), and trichloroethylene (Ref. 9), as well as the Draft TSCA
Screening Level Approach for Assessing Ambient Air and Water Exposures
to Fenceline Communities (Ref. 10). This draft risk evaluation reflects
SACC and public comments received on the Draft Human Health Hazard
Assessment for 1,2-Dichloroethane.
III. Request for Comment
EPA seeks feedback on the assessment of risk presented in the draft
risk evaluation for 1,2-dichloroethane, a copy of which is available in
the docket, and encourages all potentially interested parties,
including individuals, governmental and non-governmental organizations,
non-profit organizations, academic institutions, research institutions,
and private sector entities to comment on the draft risk evaluation. To
the extent possible, the Agency asks commenters to please cite any
public data related to or that support comments provided, and to the
extent permissible, describe any supporting data that is not publicly
available.
EPA welcomes specific input on each section of the draft risk
evaluation, particularly input on the following:
<bullet> The approach taken to evaluate the byproducts in the Draft
Byproducts Assessment for 1,2-Dichloroethane;
<bullet> The COU names and descriptions for ``Industrial use--other
use--process solvent,'' particularly whether there is overlap between
this use as a process solvent in chemical reactions (including a
proprietary use in pesticide, fertilizer, and other agricultural
chemical manufacturing) and other processing or industrial and
commercial COUs that may duplicate this newly added COU (e.g.,
Processing--incorporated into a formulation, mixture, or reaction
product);
<bullet> Whether the delineation of occupational exposure scenarios
(OESs) associated with the Disposal COU are clear and accurate;
<bullet> Whether and how exposure controls and personal protective
equipment (PPE) are used during the manufacture, processing, and use of
1,2-dichloroethane for each of the COUs. Although EPA has test order
data, additional information on when and where exposure controls and
PPE are used would be informative;
<bullet> All aspects of the approach for assessing ambient air
inhalation exposure for the general population, including exposure
input assumptions, uncertainties, as well as the calculation and
interpretation of additional cancer cases based on the population
exposed;
<bullet> Information on environmental releases for OESs for which
releases were modeled (Repackaging, Application of adhesives and
sealants, Industrial and commercial non-aerosol cleaning/degreasing,
Application of lubricants and greases, Industrial and commercial
aerosol products, and Laboratory use); and
<bullet> Information on OESs for which EPA has slight confidence on
exposures to workers and ONUs (Repackaging, Industrial and commercial
aerosol products, and Waste handling, treatment, and disposal
[landfills]), including on the degree to which 1,2-dichloroethane is
used in Industrial and commercial aerosol products. Information to help
clarify the approach EPA used to analyze OSHA CEHD, specifically the
step of removing data in which all measurements taken at the site were
recorded as ``0'' or below the limit of detection and there was no
evidence such as a bulk sample that shows the presence of the chemical
at the site as EPA assumed that the chemical of interest may not have
been at the site at the time of sampling; and
<bullet> Information (e.g., SDS documents) to inform the level of
1,2-dichloroethane in adhesives. The concentration evaluated for the
dermal exposure for the Industrial application of adhesives and
sealants OES is 91.8 percent based
[[Page 52056]]
on an SDS for an adhesive containing 1,2-dichloroethane.
IV. Next Steps
EPA will consider comments received on the draft risk evaluation
and announce the availability of the final risk evaluation for 1,2-
dichloroethane.
Under TSCA section 6, EPA must determine in the final risk
evaluation, based on the weight of scientific evidence, whether or not
the chemical presents an unreasonable risk to health or the environment
under the chemical's COUs. This includes consideration of risks to
potentially exposed or susceptible subpopulations who may be at greater
risks than the general population, such as children and workers. TSCA
prohibits EPA from considering non-risk factors (e.g., costs/benefits)
during risk evaluation.
If EPA determines in its final risk evaluation that a chemical
presents an unreasonable risk to health or the environment, the
chemical will move to risk management action under TSCA section 6(a)
for the relevant COUs. EPA would be required to implement, via
regulation, regulatory restrictions on the manufacture (including
import), processing, distribution, use or disposal of the chemical to
eliminate the identified unreasonable risk. TSCA section 6(a) includes
a range of risk management options, including labeling, recordkeeping
or notice requirements, actions to reduce human exposure or
environmental release, and a ban of the chemical or of certain uses.
Like the prioritization and risk evaluation processes, there is an
opportunity for public comment on any proposed risk management actions.
For more information about the TSCA risk evaluation process for
existing chemicals, go to <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca</a>.
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.
84 FR 71924, December 30, 2019 (FRL-10003-15).
2. EPA. Draft Scopes of the Risk Evaluations To Be Conducted for
Thirteen Chemical Substances Under the Toxic Substances Control Act;
Notice of Availability. Federal Register. 85 FR 19941, April 9, 2020
(FRL-10007-11).
3. EPA. Final Scopes of the Risk Evaluations To Be Conducted for
Twenty Chemical Substances Under the Toxic Substances Control Act;
Notice of Availability. Federal Register. 85 FR 55281, September 4,
2020 (FRL-10013-90).
4. EPA. 1,1-Dichloroethane and 1,2-Dichloroethane; Science Advisory
Committee on Chemicals (SACC) Peer Review; Notice of SACC Meeting,
Availability of Draft Documents and Request for Comment. Federal
Register. 89 FR 54815, July 2, 2024 (FRL-11809-03).
5. EPA. 1,1-Dichloroethane; Risk Evaluation Under the Toxic
Substances Control Act (TSCA); Notice of Availability. Federal
Register. 90 FR 26581, June 23, 2025 (FRL-11809-04).
6. EPA. Carbon Tetrachloride (CCl4); Final Toxic Substances Control
Act (TSCA) Risk Evaluation; Notice of Availability. Federal
Register. 85 FR 70147, November 4, 2020 (FRL-10015-51).
7. EPA. Methylene Chloride (MC); Final Toxic Substances Control Act
(TSCA) Risk Evaluation; Notice of Availability. Federal Register. 85
FR 37942, June 24, 2020 (FRL-10011-16).
8. EPA. Perchloroethylene (PCE); Final Toxic Substances Control Act
(TSCA) Risk Evaluation; Notice of Availability. Federal Register. 85
FR 82474, December 18, 2020 (FRL-10017-44).
9. EPA. Trichloroethylene (TCE); Final Toxic Substances Control Act
(TSCA) Risk Evaluation; Notice of Availability. Federal Register. 85
FR 75010, November 24, 2020 (FRL-10016-91).
10. EPA. Science Advisory Committee on Chemicals (SACC); Notice of
Public Meeting and Request for Comments on Draft Toxic Substances
Control Act (TSCA) Screening Level Approach for Assessing Ambient
Air and Water Exposures to Fenceline Communities. Federal Register.
87 FR 3294. January 21, 2022 (FRL-9392-01).
Authority: 15 U.S.C. 2601 et seq.
Dated: November 14, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and
Pollution Prevention.
[FR Doc. 2025-20240 Filed 11-18-25; 8:45 am]
BILLING CODE 6560-50-P
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