Notice2024-31280
Diisodecyl Phthalate (DIDP); Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability
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Published
January 6, 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 diisodecyl phthalate (DIDP). 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 used the best available science to prepare this final risk evaluation and determined, based on the weight of scientific evidence, that DIDP 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 90 Issue 3 (Monday, January 6, 2025)</title>
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[Federal Register Volume 90, Number 3 (Monday, January 6, 2025)]
[Notices]
[Pages 638-640]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31280]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0435]; FRL-8807-03-OCSPP]
Diisodecyl Phthalate (DIDP); Risk Evaluation Under the Toxic
Substances Control Act (TSCA); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
[[Page 639]]
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 diisodecyl phthalate (DIDP).
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 used the best available science to
prepare this final risk evaluation and determined, based on the weight
of scientific evidence, that DIDP 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-2018-0435, 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: Brianne Raccor, Existing Chemical Risk
Management Division (7404M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-0303; email address:
<a href="/cdn-cgi/l/email-protection#6b190a08080419450919020a05050e2b0e1b0a450c041d"><span class="__cf_email__" data-cfemail="176576747478653975657e767979725772677639707861">[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#87d3d4c4c6aacfe8f3ebeee9e2c7e2f7e6a9e0e8f1"><span class="__cf_email__" data-cfemail="590d0a1a187411362d3530373c193c2938773e362f">[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 DIDP, 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 all chemical substance risk evaluations. Each risk
evaluation must be conducted consistent with the best available
science, be based on the weight of the 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 risk evaluation
under TSCA for DIDP. 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 based on
the weight of scientific evidence, determined that DIDP poses
unreasonable risk to human health. 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 DIDP?
DIDP is a common chemical name for the category of chemical
substances that includes the following substances: 1,2-
benzenedicarboxylic acid, 1,2-diisodecyl ester (CASRN 26761-40-0) and
1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
(CASRN 68515-49-1). Both CASRNs contain mainly C10 dialkyl phthalate
esters. DIDP is manufactured (including imported), processed,
distributed, and disposed as part of industrial, commercial, and
consumer conditions of use. DIDP is used primarily as a plasticizer to
make flexible polyvinyl chloride (PVC). It is also used to make
building and construction materials; automotive articles; and other
commercial and consumer products including adhesives and sealants,
paints and coatings, and electrical and electronic products. The
production volume of DIDP has increased significantly over the past
decade from between 100 and 250 million pounds in 2015 to between 100
million and 1 billion pounds in 2019.
B. Risk Evaluation of DIDP
In May 2019, EPA received a request to conduct a risk evaluation
DIDP from ExxonMobil Chemical Company, Evonik Corporation, and Teknor
Apex, through the American Chemistry Council's High Phthalates Panel
(ACC HPP). In December 2019, EPA notified ACC HPP that the Agency had
granted the manufacturer requested risk evaluation. See EPA-HQ-OPPT-
2018-0435 (Ref. 1). In November 2020, EPA released the draft scope of
the DIDP risk evaluation (Ref. 2) and, after considering public
comments, issued the final problem formulation in August 2021 (Ref. 3).
On February 29, 2024, EPA released a draft risk evaluation for public
comment and peer review by the Science Advisory Committee on Chemicals
(SACC). (Ref. 4). The draft documents and public comments are in docket
ID number EPA-HQ-OPPT-2024-0073. A non-technical summary is also
available (Ref. 5). Given the shared peer review and chemical
similarities with DINP, a shared set of responses to peer review and
public comments will be available in January 2025 when the final
Diisononyl Phthalate (DINP) risk evaluation is released (Ref. 6).
III. Unreasonable Risk Determination
EPA has determined that DIDP presents an unreasonable risk of
injury to human health under the conditions of use. EPA did not
identify risk of injury to the environment that would contribute to the
unreasonable risk determination for DIDP. EPA has determined that the
unreasonable risk to human health presented by DIDP is due to non-
cancer effects (i.e., reduced offspring survival) in female workers of
reproductive age from acute inhalation exposures and acute aggregated
exposures. The unreasonable risk determination is based on the
information within the risk evaluation, the appendices, and technical
support documents of the risk evaluation in accordance with TSCA
section 6(b). It is also based on TSCA's best available science (TSCA
section 26(h)), weight of scientific evidence standards (TSCA section
26(i)), and relevant implementing regulations in 40 CFR part 702,
including, to the extent practicable, the amendments to the procedures
for chemical risk evaluation
[[Page 640]]
under TSCA finalized in May 2024 (89 FR 37028; May 3, 2024).
Between release of the draft risk evaluation and finalization of
the DIDP risk evaluation, EPA updated the risk determination to find
that six COUs contribute to unreasonable risk of DIDP based on new
information identified by EPA, information provided by public
commenters, and recommendations of the SACC. These changes stem from
consideration of 1) multiple factors impacting occupational exposure
during spray application, 2) applicability of developmental effects to
average adult workers, and 3) identification of DIDP-containing
products that could be spray applied. The COUs that EPA identified as
presenting unreasonable risk were for acute exposure scenarios in which
unprotected female workers of reproductive age were to spray adhesives
and sealants; paints and coatings; lacquers, stains, varnishes, and
floor finishes; or penetrants and inspection fluids that contain DIDP,
because doing so could create high concentrations of DIDP in mist that
an unprotected worker could inhale. The human health hazard that EPA
identified as having the strongest evidence to support this risk
evaluation is developmental toxicity, which means that laboratory
animals dosed with DIDP had litters where more rodent offspring died
than was the case with the litters of rodents that were not dosed with
DIDP. As the most sensitive health effects of concern relate to
exposure of the developing fetus during gestation, the population to
which this risk determination is most relevant is female workers of
reproductive age.
Consistent with the statutory requirements of TSCA section 6(a),
EPA will propose a risk management regulatory action to the extent
necessary so that DIDP 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. However, it
should be noted that, under TSCA section 6(a), EPA is not limited to
regulating the specific activities found to drive unreasonable risk and
may select from among a suite of risk management requirements in
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.,
industrial and commercial uses) driving unreasonable risk, even if the
upstream activities do not drive the unreasonable risk. 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>.
IV. 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. Di-isodecyl Phthalate (DIDP); Manufacturer Request for Risk
Evaluation Under the Toxic Substances Control Act (TSCA); Notice of
Availability and Request for Comments. Federal Register. 84 FR
42914, August 19, 2019 (FRL-9998-26).
2. EPA. Di-isodecyl Phthalate (DIDP); 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 76077, November 27, 2020 (FRL-10017-14).
3. EPA. Di-isodecyl Phthalate (DIDP); Final Scope of the Risk
Evaluation To Be Conducted Under the Toxic Substances Control Act
(TSCA); Notice of Availability. Federal Register. 86 FR 48695,
August 31, 2021 (FRL-8807-01-OCSPP).
4. EPA. Di-isodecyl Phthalate (DIDP) and Di-isononyl Phthalate
(DINP); Science Advisory Committee on Chemicals (SACC) Peer Review
of Draft Documents; Notice of SACC Meeting; Availability; and
Request for Comment. Federal Register. 89 FR 43847, May 20, 2024
(FRL-11760-02-OCSPP).
5. EPA. Nontechnical Summary of the TSCA Risk Evaluation for
Diisodecyl Phthalate (DIDP). December 2024. (EPA Document ID No.
EPA-740-S-24-008).
6. EPA. Comment Summary and Responses for Diisodecyl Phthalate
(DIDP) and Diisononyl Phthalate (DINP). December 2024.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 20, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-31280 Filed 1-3-25; 8:45 am]
BILLING CODE 6560-50-P
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