Notice2024-26342
1,4-Dioxane; Supplement to the Risk Evaluation and Revised Unreasonable Risk Determination Under the Toxic Substances Control Act (TSCA); Notice of Availability
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Published
November 14, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or the Agency) is announcing the availability of the final supplement to the risk evaluation and revised unreasonable risk determination under the Toxic Substances Control Act (TSCA) for 1,4-dioxane. The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to human health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the conditions of use. The Agency used the best available science to prepare this final supplement to the risk evaluation and has determined that 1,4-dioxane poses unreasonable risk to human health. Under TSCA, EPA must initiate risk management actions to address the unreasonable risk.
Full Text
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<title>Federal Register, Volume 89 Issue 220 (Thursday, November 14, 2024)</title>
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[Federal Register Volume 89, Number 220 (Thursday, November 14, 2024)]
[Notices]
[Pages 89993-89995]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-26342]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2016-0723; FRL-7918-03-OCSPP]
1,4-Dioxane; Supplement to the Risk Evaluation and Revised
Unreasonable Risk Determination Under the Toxic Substances Control Act
(TSCA); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
announcing the availability of the final supplement to the risk
evaluation and revised unreasonable risk determination under the Toxic
Substances Control Act (TSCA) for 1,4-dioxane. The purpose of risk
evaluations under TSCA is to determine whether a chemical substance
presents an unreasonable risk of injury to human health or the
environment, without consideration of costs or non-risk factors,
including unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant to the risk evaluation by EPA,
under the conditions of use. The Agency used the best available science
to prepare this final supplement to the risk evaluation and has
determined that 1,4-dioxane poses unreasonable risk to human health.
Under TSCA, EPA must initiate risk management actions to address the
unreasonable risk.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2016-0723, 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: Cindy Wheeler, Existing Chemicals Risk
Management Division (7404M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 566-0484; email address:
<a href="/cdn-cgi/l/email-protection#80c4e9eff8e1eee5aed4d3c3c1c0e5f0e1aee7eff6"><span class="__cf_email__" data-cfemail="cd89a4a2b5aca3a8e3999e8e8c8da8bdace3aaa2bb">[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#4c181f0f0d61042338202522290c293c2d622b233a"><span class="__cf_email__" data-cfemail="6d393e2e2c40250219010403082d081d0c430a021b">[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, processing,
distribution, use, and disposal of 1,4-dioxane, 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 all chemical substance risk evaluations. Each risk
evaluation must be conducted consistent with the best available
science, be based on the weight of
[[Page 89994]]
scientific evidence and consider reasonably available information. 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 the final supplement to the
1,4-dioxane risk evaluation and final revised unreasonable risk
determination under TSCA. 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, without consideration of costs
or non-risk factors, including unreasonable risk to potentially exposed
or susceptible subpopulations identified as relevant to the risk
evaluation by EPA, under the conditions of use. EPA has used the best
available science to prepare this final risk evaluation and has
determined that 1,4-dioxane poses unreasonable risk to human health.
Upon a determination of unreasonable risk, EPA must initiate risk
management action as required pursuant to 15 U.S.C 2605(a) to address
the unreasonable risk.
II. Background
In 2016, EPA announced its designation of 1,4-dioxane for risk
evaluation under TSCA (81 FR 91927, December 19, 2016 (FRL-9956-47)).
1,4-Dioxane was one of the first 10 chemical substances undergoing the
TSCA risk evaluation process after passage of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, which amended TSCA. 1,4-
Dioxane is primarily used as a solvent in a variety of commercial and
industrial applications such as the manufacture of other chemicals
(e.g., adhesives, sealants) or as a processing aid or laboratory
chemical. Although there are no direct consumer uses of 1,4-dioxane, it
is present as a contaminant in commercial and consumer products and is
produced as a byproduct through several manufacturing processes
including ethoxylation, sulfonation, sulfation, and esterification.
In the ``Draft Risk Evaluation for 1,4-Dioxane'' released in June
2019 (hereafter ``2019 draft risk evaluation'') (84 FR 31315, July 1,
2019 (FRL-9995-40)), EPA reviewed the exposures and hazards of 1,4-
dioxane for industrial and commercial uses and assessed risk from
occupational exposures and surface water exposures to environmental
organisms. That assessment, which included the physical and chemical
properties, lifecycle information, environmental fate and transport
information, and hazard identification and dose-response analysis, was
peer reviewed by the Science Advisory Committee on Chemicals (SACC). In
November 2020, EPA released the ``Draft Supplemental Analysis to the
Draft Risk Evaluation for 1,4-Dioxane'' (hereafter ``2020 draft
supplement'') that assessed conditions of use (COUs) of 1,4-dioxane as
a contaminant in consumer products and general population exposure from
incidental contact with surface water. The Agency determined that the
2020 draft supplement did not warrant additional peer review as there
was no novel analysis. The 2019 draft risk evaluation and 2020 draft
supplement were both incorporated into the ``Final Risk Evaluation for
1,4-Dioxane'' that was released in December 2020 (hereinafter ``2020
final risk evaluaton'').
In early 2021, and in response to presidential executive orders and
policy changes, EPA reviewed the risk evaluations for the first 10
chemical substances to ensure that the risk evaluations met the
requirements of TSCA, including the requirement to use the best
available science in decision-making. As a result of that review, the
Agency announced plans to revise specific aspects of the first 10 risk
evaluations to ensure that they appropriately identify unreasonable
risks and thereby help to ensure the protection of human health and the
environment. EPA determined an additional supplement to the 2020 final
risk evaluation was needed to consider critical exposure pathways not
previously assessed. Specifically, that additional supplement
(hereinafter ``2023 draft supplement'') includes evaluation of
additional conditions of use in which 1,4-dioxane is a byproduct in
industrial processes and a contaminant in certain commercial products,
and evaluates risks from general population exposures to 1,4-dioxane
released to ambient surface water and groundwater, ambient air, and
land. To evaluate these additional exposure pathways, the Agency used
new methods and novel applications of existing methods. These new
methods were subject to public comment and peer review as part of the
2023 draft supplement (88 FR 48249, July 26, 2023 (FRL-7918-02-OCSPP)).
Along with the 2023 draft supplement, EPA also published and took
public comment on draft revisions to the unreasonable risk
determination for 1,4-dioxane that considers the 2020 risk evaluation
and the 2023 draft supplement. The 2023 draft revision to the
unreasonable risk determination reflects policy changes announced in
June 2021, and EPA preliminarily determined that 1,4-dioxane presents
an unreasonable risk of injury to health when evaluated under its
conditions of use.
The final revised unreasonable risk determination that is being
released with this announcement considers the 2020 risk evaluation and
the final supplement that is also being released with this
announcement. This final revised unreasonable risk determination
supersedes the condition of use-specific no unreasonable risk
determinations in the 2020 risk evaluation (and withdraws the
associated order) and makes a final determination of unreasonable risk
for 1,4-dioxane as discussed in Unit III.
III. Unreasonable Risk Determination
EPA has determined that 1,4-dioxane presents an unreasonable risk
of injury to human health under the conditions of use. The Agency has
determined that the unreasonable risk to human health presented by 1,4-
dioxane is based on cancer and non-cancer risks (from liver toxicity
and effects in the olfactory epithelium) to workers and occupational
non-users (ONUs) from inhalation and dermal exposures, and cancer risks
to the general population, including fenceline communities, from
exposures to 1,4-dioxane in drinking water sourced from surface water
contaminated with industrial discharges of 1,4-dioxane (including when
it is generated as a byproduct) and down-the-drain disposals of
commercial and consumer products that are contaminated with 1,4-dioxane
generated as a byproduct.
Consistent with the statutory requirements of TSCA section 6(a),
EPA will propose risk management regulatory actions to the extent
necessary so that 1,4-dioxane no longer presents an unreasonable risk
to health. The Agency expects to focus its risk management action on
the conditions of use that significantly contribute to the unreasonable
risk. However, it should be noted that under TSCA section 6(a), EPA is
not limited to regulating the specific activities found to contribute
significantly to unreasonable risk and may select from among a suite of
risk management requirements in TSCA section 6(a) related to
manufacture (including import), processing, distribution in commerce,
commercial use, and disposal as part of its regulatory options to
address the unreasonable risk. As a general example, EPA may regulate
upstream activities (e.g., processing, distribution in commerce) to
address downstream activities (e.g., consumer uses) contributing
significantly to unreasonable risk, even if the upstream
[[Page 89995]]
activities do not contribute significantly to the unreasonable risk.
In addition, as part of its evaluation, EPA has determined that
1,4-dioxane in drinking water sourced from surface water contaminated
with industrial discharges of 1,4-dioxane (including when it is
generated as a byproduct) and down-the-drain disposals of commercial
and consumer products that are contaminated with 1,4-dioxane
significantly contribute to the unreasonable risk from 1,4-dioxane.
TSCA section 9(b) requires EPA to coordinate TSCA actions with actions
taken under other Agency authorities. In coordinating regulatory action
under TSCA with other offices at EPA, the Agency considered the
authorities of the Safe Drinking Water Act (SDWA) and has determined
that certain regulatory actions under the SDWA may also be appropriate.
Therefore, as described in more detail in a memorandum included in this
docket, and consistent with TSCA section 9(b)(1), OCSPP has
memorialized this agreement for coordinated action on risks from 1,4-
dioxane contamination in drinking water through actions under both TSCA
section 6(a) and, for Office of Water consideration of remaining risks
and appropriate action, under SDWA.
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>.
Authority: 15 U.S.C. 2601 et seq.
Dated: November 7, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-26342 Filed 11-13-24; 8:45 am]
BILLING CODE 6560-50-P
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