Diisodecyl Phthalate (DIDP); Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability, 638-640 [2024-31280]
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Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Notices
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
[Project No. P–2299–082]
Turlock & Modesto Irrigation District;
Notice of Reasonable Period of Time
for Water Quality Certification
Application
On December 13, 2024, the Turlock &
Modesto Irrigation District submitted to
the Federal Energy Regulatory
Commission (Commission) a copy of its
application for Clean Water Act section
401(a)(1) water quality certification filed
with the California State Water
Resources Control Board (Water Board),
in conjunction with the above captioned
project. The submittal also included a
response from the Water Board stating
that it received the application on the
same day. Pursuant to section 5.23(b) of
the Commission’s regulations,1 we
hereby notify the Water Board of the
following:
Date of Receipt of the Certification
Request: December 13, 2024.
Reasonable Period of Time to Act on
the Certification Request: December 13,
2025.
If the Water Board fails or refuses to
act on the water quality certification
request on or before the above date, then
the certifying authority is deemed
waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C.
1341(a)(1).
Dated: December 30, 2024.
Debbie-Anne A. Reese,
Secretary.
[FR Doc. 2024–31651 Filed 1–3–25; 8:45 am]
BILLING CODE 6717–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2017–0751; FRL–12478–01–
OCSPP]
chemicals: 1,3–PAD, chlorothalonil,
thiophanate-methy/carbendazim, and
TCMTB.
FOR FURTHER INFORMATION CONTACT:
For pesticide specific information,
contact: The Chemical Review Manager
for the pesticide of interest identified in
table 1 of unit I.
For general information on the
registration review program, contact:
Melanie Biscoe, Pesticide Re-Evaluation
Division (7508P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 566–0701; email address:
biscoe.melanie@epa.gov.
SUPPLEMENTARY INFORMATION:
Pesticide Registration Review;
Decisions and Case Closures for
Several Pesticides; Notice of
Availability
I. Purpose of This Notice
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
This notice announces the
availability of EPA’s interim registration
review decisions for the following
SUMMARY:
Pursuant to 40 CFR 155.58(c), this
notice announces the availability of
EPA’s interim or final registration
review decisions for the pesticides
shown in table 1. The interim
registration review decisions are
supported by rationales included in the
docket established for each chemical.
TABLE 1—INTERIM REGISTRATION REVIEW DECISIONS BEING ISSUED
Registration review case name and No.
Chemical review manager and contact information
1,3–PAD; Case Number 5109 .......................................
EPA–HQ–OPP–2014–0406
2-(thiocyanomethylthio) benzothiazole (TCMTB); Case
Number 2625.
Chlorothalonil; Case Number 0097 ................................
EPA–HQ–OPP–2014–0405
Thiophanate-methyl and carbendazim; Case Number
2680.
EPA–HQ–OPP–2014–0004
II. Background
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Docket ID No.
EPA is conducting its registration
review of the chemicals listed in table
1 of unit I pursuant to the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) section 3(g) (7 U.S.C.
136a(g)) and the Procedural Regulations
for Registration Review at 40 CFR part
155, subpart C. FIFRA section 3(g)
provides, among other things, that
pesticide registrations are to be
reviewed every 15 years. Consistent
with 40 CFR 155.57, in its final
registration review decision, EPA will
ultimately determine whether a
pesticide continues to meet the
registration standard in FIFRA section
3(c)(5) (7 U.S.C. 136a(c)(5)). As part of
the registration review process, the
1 18
EPA–HQ–OPP–2011–0840
Areej Jahangir, jahangir.areej@epa.gov, (202) 566–
1577.
Erin Dandridge, dandridge.erin@epa.gov, (202) 566–
0635.
Rachel Blatnick, blatnick.rachel@epa.gov, (202) 566–
2223.
Alex McKee, mckee.alex@epa.gov, (202) 566–1939.
Megan Snyderman, snyderman.megan@epa.gov,
(202) 566–0639.
Agency has completed interim
registration review decisions for the
pesticides in table 1 of unit I.
Prior to completing the interim review
decisions in table 1 of unit I, EPA
posted proposed interim decisions or
proposed registration review decisions
for these chemicals and invited the
public to submit any comments or new
information, consistent with 40 CFR
155.58(a). EPA considered and
responded to any comments or
information received during these
public comment periods in the
respective interim decision or final
registration review decisions.
For additional background on the
registration review program, see: https://
www.epa.gov/pesticide-reevaluation.
Authority: 7 U.S.C. 136 et seq.
Dated: December 31, 2024.
Jean Anne Overstreet,
Director, Pesticide Re-Evaluation Division,
Office of Pesticide Programs.
[FR Doc. 2024–31644 Filed 1–3–25; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
AGENCY:
CFR 5.23(b).
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Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Notices
ACTION:
Notice.
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 https://
www.regulations.gov. Additional
information about dockets generally,
along with instructions for visiting the
docket in-person, is available at https://
www.epa.gov/dockets.
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:
raccor.brianne@epa.gov.
For general information: The TSCAHotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620;
telephone number: (202) 554–1404;
email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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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, nongovernmental 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
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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: 1,2benzenedicarboxylic acid, 1,2diisodecyl ester (CASRN 26761–40–0)
and 1,2-benzenedicarboxylic acid, diC9-11-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
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639
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 nontechnical 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
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Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Notices
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 DIDPcontaining 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
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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 https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca.
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 Diisononyl 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]
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OAR–2023–0151; FRL–10890–02–
OAR]
California State Nonroad Engine
Pollution Control Standards; Small OffRoad Engines Regulations; Notice of
Decision
Environmental Protection
Agency (EPA).
ACTION: Notice of decision.
AGENCY:
The Environmental Protection
Agency (‘‘EPA’’) is providing notice of
its decision granting the California Air
Resources Board’s (‘‘CARB’s’’) request
for an authorization of amendments to
its small off-road engine (‘‘SORE’’)
regulations. CARB’s amendments
covered by this authorization include
those adopted by CARB in 2016 and
2021. EPA’s decision was issued under
the authority of section 209 of the Clean
Air Act (‘‘CAA’’ or ‘‘Act’’).
DATES: Petitions for review must be filed
by March 7, 2025.
ADDRESSES: EPA has established a
docket for this action under Docket ID
EPA–HQ–OAR–2023–0151. All
documents relied upon in making this
decision, including those submitted to
EPA by CARB, are contained in the
public docket. Publicly available docket
materials are available either
electronically through
www.regulations.gov or in hard copy at
the EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution
Avenue NW, Washington, DC 20004.
The Docket Center’s hours of operation
are 8:30 a.m. to 4:30 p.m.; generally, it
is open Monday through Friday, except
Federal holidays. The electronic mail
(email) address for the EPA Docket is: aand-r-Docket@epa.gov. An electronic
version of the public docket is available
through the Federal government’s
electronic public docket and comment
system. You may access EPA dockets at
https://www.regulations.gov. After
opening the www.regulations.gov
website, enter EPA–HQ–OAR–2023–
0151 in the ‘‘Enter Keyword or ID’’ fillin box to view documents in the record.
Although a part of the official docket,
the public docket does not include
Confidential Business Information
(‘‘CBI’’) or other information whose
disclosure is restricted by statute.
EPA’s Office of Transportation and
Air Quality (‘‘OTAQ’’) maintains a web
page that contains general information
on its review of California waiver and
authorization requests. Included on that
page are links to prior waiver Federal
Register notices, some of which are
SUMMARY:
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]]>Agencies
[Federal Register Volume 90, Number 3 (Monday, January 6, 2025)]
[Notices]
[Pages 638-640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31280]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at https://www.epa.gov/dockets.
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:
[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, 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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.
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
