Notice2025-11438
1,1-Dichloroethane; Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability
Primary source
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Published
June 23, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is announcing the availability of the final risk evaluation under the Toxic Substances Control Act (TSCA) for 1,1-dichloroethane (CASRN 75- 34-3). 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. EPA used the best available science to prepare this final risk evaluation and determined, based on the weight of scientific evidence, that 1,1-dichloroethane presents unreasonable risk to human health driven by three conditions of use because of risks to workers.
Full Text
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<title>Federal Register, Volume 90 Issue 118 (Monday, June 23, 2025)</title>
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[Federal Register Volume 90, Number 118 (Monday, June 23, 2025)]
[Notices]
[Pages 26581-26583]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11438]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0114; FRL-11809-04-OCSPP]
1,1-Dichloroethane; Risk Evaluation Under the Toxic Substances
Control Act (TSCA); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
[[Page 26582]]
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
announcing the availability of the final risk evaluation under the
Toxic Substances Control Act (TSCA) for 1,1-dichloroethane (CASRN 75-
34-3). 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. EPA used the best available
science to prepare this final risk evaluation and determined, based on
the weight of scientific evidence, that 1,1-dichloroethane presents
unreasonable risk to human health driven by three conditions of use
because of risks to workers.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2024-0114, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
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 Chemicals
Risk Assessment Division (6.6308-AA), 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#97a6b9a6b9d3fef4fffbf8e5f8f2e3fff6f9f2b9c3c4d4d6d7f2e7f6b9f0f8e1"><span class="__cf_email__" data-cfemail="99a8b7a8b7ddf0faf1f5f6ebf6fcedf1f8f7fcb7cdcadad8d9fce9f8b7fef6ef">[email protected]</span></a>.
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave. Rochester, NY 14620; telephone number: (202) 554-1404;
email address: <a href="/cdn-cgi/l/email-protection#37636474761a7f58435b5e59527752475619505841"><span class="__cf_email__" data-cfemail="cc989f8f8de184a3b8a0a5a2a98ca9bcade2aba3ba">[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 1,1-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 conducted 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 evaluation. Each risk evaluation must be conducted
consistent with the best available science, be based on the weight of
the 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 and 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>.
C. What action is the Agency taking?
EPA is announcing the availability of the final risk evaluation
under TSCA for 1,1-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
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. EPA has used the best available science to prepare this final
risk evaluation and, based on the weight of scientific evidence,
determined that 1,1-dichloroethane poses unreasonable risk to human
health driven by three conditions of use because of risks to workers.
Upon a determination of unreasonable risk, EPA must initiate risk
management action as required pursuant to TSCA section 6(a), 15 U.S.C.
2605(a), to address the unreasonable risk.
II. Background
A. What is 1,1-dichloroethane?
1,1-Dichloroethane, a chlorinated solvent, is a colorless, oily
liquid with a chloroform- or ether-like odor. It is both volatile and
soluble in water. It is used to produce other chlorinated solvents that
have broad industrial applications. Relatively small amounts of 1,1-
dichloroethane support commercial use as a laboratory chemical. The
reported total domestic production volume in 2020 was between 100
million and 1 billion pounds for two corporations located in the
southern United States.
B. Summary of Activities for the Risk Evaluation of 1,1-Dichloroethane
In December 2019, EPA announced its designation of 1,1-
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 1,1-dichloroethane risk evaluation (Ref. 2), and after
considering public comments, issued the final scope in August 2020
(Ref. 3). In July 2024, EPA released the draft risk evaluation 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 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>.
These documents, other supporting documents, and public comments
are in docket EPA-HQ-OPPT-2018-0426 and docket EPA-HQ-OPPT-2024-0114.
The following three documents are being released with this notice:
<bullet> A response to comments document entitled, ``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;''
<bullet> A nontechnical summary of the final risk evaluation
entitled, ``Nontechnical Summary of the TSCA Risk Evaluation for 1,1-
Dichloroethane;'' and
<bullet> The final risk evaluation entitled, ``Risk Evaluation for
1,1-Dichloroethane.''
III. Unreasonable Risk Determination
EPA determined that 1,1-dichloroethane presents an unreasonable
risk of injury to human health driven by three of the eight conditions
of use (COUs). The three COUs that significantly contribute to the
unreasonable risk determination for 1,1-dichloroethane based on
identified risk to workers due to non-cancer and cancer effects due to
inhalation exposure are:
<bullet> Processing as a reactant--intermediate in all other basic
organic chemical manufacturing;
<bullet> Processing as a reactant--intermediate in all other
chemical
[[Page 26583]]
product and preparation manufacturing; and
<bullet> Processing--recycling.
The unreasonable risk identified would no longer be unreasonable
when using respirators in a manner that achieves a minimum Assigned
Protection Factor (APF) 10 to 25 (depending on the expected workplace
activity, represented in the risk evaluation by Similar Exposure Groups
(SEGs)) or implementing other exposure controls (e.g., engineering
controls) that may be equally or more effective in reducing worker
exposures. EPA received inhalation monitoring data from a TSCA section
4(a)(2) test order submission for the manufacture of 1,1-dichloroethane
as an isolated intermediate. The test order submission characterized
the facility control operations known and expected to be in place
depending on the potential exposure during standard, task-specific, and
emergency activities--including engineering controls, administrative
controls, personal protective equipment (PPE) (e.g., respirators
achieving a level of APF 10-1,000), and chemical safety plans.
Consistent with the amendments to the procedures for chemical risk
evaluation under TSCA finalized in May 2024 (89 FR 37028; May 3, 2024),
EPA considered all reasonably available information, including this
test order data substantiating the use of PPE, when determining what
COUs significantly contribute to the unreasonable risk determination.
EPA did not identify unreasonable risk of injury to workers from non-
cancer dermal exposure, or unreasonable risk of injury to occupational
non-users, the general population, or the environment under any COUs.
IV. Next Step is Risk Management
Consistent with TSCA section 6(a), EPA will propose a risk
management regulatory action applying requirements to the extent
necessary so that 1,1-dichloroethane no longer presents an unreasonable
risk. EPA expects to focus its risk management action on the conditions
of use that significantly contribute to the unreasonable risk. In
proposing a rule and selecting among requirements, consistent with TSCA
section 6(c)(2), EPA will consider and factor in, to the extent
practicable: (i) the effects of 1,1-dichloroethane on health and the
environment, (ii) the magnitude of exposure to 1,1-dichloroethane of
human beings and the environment, (iii) the benefits of 1,1-
dichloroethane for various uses, and (iv) the reasonably ascertainable
economic consequences of the rule.
Like the prioritization and risk evaluation processes, there will
be an opportunity for public comment on any proposed risk management
actions.
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 and Initiation of Risk Evaluation on High-
Priority Substances. Federal Register. 84 FR 71924, December 30,
2019 (FRL-10003-15).
2. EPA. 1,1-Dichloroethane; Draft Scope of the Risk Evaluation to be
Conducted under the Toxic Substances Control Act (TSCA); Notice of
Availability and Request for Comments. Federal Register. 85 FR
19941, April 9, 2020 (FRL-10007-11).
3. EPA. 1,1-Dichloroethane; Final Scope of the Risk Evaluation to be
Conducted under the Toxic Substances Control Act (TSCA); Notice of
Availability. Federal Register. 85 FR 55281, September 4, 2020 (FRL-
10013-90).
4. EPA. 1,1-Dichloroethane; Draft Risk Evaluation under the Toxic
Substances Control Act (TSCA); Notice of Availability and Request
for Comments. Federal Register. 89 FR 54815, July 2, 2024 (FRL-
11809-03).
Authority: 15 U.S.C. 2601 et seq.
Dated: June 17, 2025.
Nancy B. Beck,
Principal Deputy Assistance Administrator, Office of Chemical Safety
and Pollution Prevention.
[FR Doc. 2025-11438 Filed 6-20-25; 8:45 am]
BILLING CODE 6560-50-P
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