Notice2024-19698
Di-isononyl phthalate (DINP); Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability, Webinar and Request for Comment
Primary source
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Published
September 3, 2024
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 di- isononyl phthalate (DINP) (1,2-Benzene- dicarboxylic acid, 1,2- diisononyl ester) (CASRN 28553-12-0). 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 (COU). EPA has used the best available science to prepare this draft risk evaluation and to preliminarily determine that DINP poses unreasonable risk to human health.
Full Text
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<title>Federal Register, Volume 89 Issue 170 (Tuesday, September 3, 2024)</title>
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[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71270-71272]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19698]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0436; FRL-8806-02-OCSPP]
Di-isononyl phthalate (DINP); Draft Risk Evaluation Under the
Toxic Substances Control Act (TSCA); Notice of Availability, Webinar
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 di-
isononyl phthalate (DINP) (1,2-Benzene- dicarboxylic acid, 1,2-
diisononyl ester) (CASRN 28553-12-0). 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
(COU). EPA has used the best available science to prepare this draft
risk evaluation and to preliminarily determine that DINP poses
unreasonable risk to human health.
DATES: Written comments: Comments must be received on or before
November 4, 2024.
Webinar on: September 26, 2024, 2-3 p.m. EST.
Register by: September 8, 2024, 12 p.m. EST, to receive the webcast
meeting link and audio teleconference information before the meeting.
Request special accommodation by: September 8, 2024, 5 p.m. EST, to
allow EPA time to process the request before the meeting.
Special accommodations: In addition, To allow EPA time to process
your request, please submit your request to EPA by 5 p.m. EST on
September 8, 2024, 5 p.m.
ADDRESSES:
Registration: Register online at <a href="https://usepa.zoomgov.com/meeting/register/vJIsc-mprzguHuiI1Lu5jNuwk-Q84wPrRr8">https://usepa.zoomgov.com/meeting/register/vJIsc-mprzguHuiI1Lu5jNuwk-Q84wPrRr8</a>.
Special accommodation requests: Submit your request to the webinar
contact person listed under FOR FURTHER INFORMATION CONTACT.
Written comments: Submit your comments, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0436, 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:
Webinar information: Sarah Soliman, Project Management and
Operations Division (7407M), Office of Chemical Safety and Pollution
Prevention, Environmental Protection Agency, 1201 Constitution Ave. NW,
Washington, DC 20004; telephone number: (202) 564-8820; email address:
<a href="/cdn-cgi/l/email-protection#01726e6d686c606f2f7260736069416471602f666e77"><span class="__cf_email__" data-cfemail="3645595a5f5b575818455744575e7653465718515940">[email protected]</span></a>.
Chemical specific information: Todd Coleman, 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) 564-1208; email address:
<a href="/cdn-cgi/l/email-protection#b8dbd7d4ddd5d9d696ccd7dcdcf8ddc8d996dfd7ce"><span class="__cf_email__" data-cfemail="294a46454c444847075d464d4d694c5948074e465f">[email protected]</span></a>.
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#1d494e5e5c30557269717473785d786d7c337a726b"><span class="__cf_email__" data-cfemail="d98d8a9a98f491b6adb5b0b7bc99bca9b8f7beb6af">[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 the chemical being evaluated,
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 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 and seeking public comment on
a draft risk evaluation under TSCA for DINP (CASRN 28553-12-0). The
purpose of
[[Page 71271]]
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 COU. This draft risk evaluation is consistent with the best
available science, based on the weight of scientific evidence, and
considers reasonably available information. EPA has preliminarily
determined that DINP poses unreasonable risk to human health.
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 DINP?
DINP is a common chemical name for the category of chemical
substances that includes the following substances: 1,2-
benzenedicarboxylic acid, 1,2-isononyl ester (CASRN 28553-12-0) and
1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C9-rich
(CASRN 68515-48-0). Both CASRNs contain mainly C9 dialkyl phthalate
esters. Both DINP, and another phthalate also undergoing TSCA risk
evaluation, DIDP (1,2-Benzene- dicarboxylic acid, 1,2- diisodecyl
ester, CASRN 26761-40-0 and 68515-49-1), are primarily used as
plasticizers in polyvinyl chloride (PVC) in consumer, commercial, and
industrial applications. DIDP and DINP are both structurally similar
phthalates, and therefore many aspects of physical-chemical (p-chem)
properties and exposure (to humans and ecological species) are similar,
as described further in the draft physical chemical and fate
assessments for both chemical substances.
B. Why is EPA evaluating this chemical under TSCA?
On May 24, 2019, EPA received requests to conduct risk evaluations
for both DINP and 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 their manufacturer requested risk
evaluations. See [insert cite to the FRN that announced this]. On May
17, 2024, EPA released for public comment and peer review draft
technical support documents on DINP's physical chemical properties,
fate and transport in the environment, environmental hazard for
terrestrial and aquatic species, human health non-cancer hazards, and
human health cancer hazards. See 89 FR 43847, May 20, 2024 (FRL-11760-
02-OCSPP). The draft documents and public comments are in docket ID
number EPA-HQ-OPPT-2024-0073.
Given the similar exposure and physical chemical properties of DIDP
and DINP, EPA is developing these individual risk evaluations in
parallel, and similarly the external peer review of the methods and
novel analyses for the draft risk evaluations are occurring
concurrently. Due to these similarities, EPA sought external peer
review of technical portions of the DINP draft physical chemical
properties, the fate and transport in the environment, environmental
hazard for terrestrial and aquatic species, human health non-cancer
hazards, and human health cancer hazards technical support documents,
along with the DIDP draft risk evaluation. Thus, the focus of this
public comment period is to solicit feedback regarding DINP-specific
exposure analyses and the integration of these analyses with previously
peer reviewed data.
DINP exhibits extremely low water solubility and will be
preferentially sorbed into sediments, soils, and suspended solids in
surface water and wastewater. It is expected to be persistent in
anaerobic environments. Under indoor settings, DINP is expected to
partition to airborne particles and is expected to have extended
lifetime compared to outdoor settings. Liver and developmental toxicity
are indicated as the most sensitive and robust non-cancer hazards for
DINP. Developmental toxicity results in androgen insufficiency
(phthalate syndrome), and effects on the liver include cancer.
The Agency has evaluated the health and environmental risks of DINP
under TSCA section 6. In its draft risk evaluation, EPA's protective,
screening-level approaches demonstrated that DINP does not pose risk to
the environment or the general population. Of the 45 COUs that EPA
evaluated, two COUs have risk estimates that raise concerns for
workers' exposure and one COU has risk estimates that raise concerns
for consumers. Based on these concerns, EPA preliminarily finds that
DINP presents an unreasonable risk of injury to human health.
After this draft risk evaluation is informed by public comment, EPA
will issue a final risk evaluation that includes its determination as
to whether DINP presents unreasonable risk to health or the environment
under its COUs. EPA also continues to work on the draft risk
evaluations of five additional high-priority chemical substance
phthalates, in addition to a draft cumulative risk assessment (CRA) for
DINP and the other five phthalates.
III. Request for Comment
EPA seeks feedback on the assessment of risk presented in the draft
risk evaluation, 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 supports comments, and to the extent
permissible, describe any supporting data that is not publicly
available.
Because many of the DINP technical support documents have undergone
public comment and are currently undergoing external peer review, input
on the following is of particular interest to the EPA:
<bullet> Sections 3, 4 and 5 of the Draft Risk Evaluation for DINP;
<bullet> Draft Environmental Release and Occupational Exposure
Assessment for DINP;
<bullet> Draft Consumer and Indoor Exposure Assessment for DINP;
<bullet> Draft Environmental Media and General Population Screening
for DINP;
<bullet> Draft Environmental Exposure Assessment for DINP;
<bullet> Whether high-pressure spray applications of DINP-
containing adhesives and sealants and paints and coatings are currently
in use in industrial settings, or may be used in the future due to
changing industrial practices.
[[Page 71272]]
IV. Next Steps
At the conclusion of the risk evaluation phase, EPA must use the
risk evaluation as a basis to determine whether the chemical presents
an unreasonable risk to health or the environment under the chemical's
COUs. TSCA prohibits EPA from considering non-risk factors (e.g.,
costs/benefits) during risk evaluation. This includes risks to
subpopulations who may be at greater risks than the general population,
such as children and workers.
If at the end of the risk evaluation process, EPA determines that a
chemical substance presents an unreasonable risk to health or the
environment, the chemical substance must immediately move to risk
management rulemaking action under TSCA. At the risk management stage,
EPA is required to implement, via regulation, regulatory restrictions
on the manufacture, processing, distribution, use or disposal of the
chemical substance to eliminate the unreasonable risk. EPA is given a
range of risk management options under TSCA, including labeling,
recordkeeping or notice requirements, actions to reduce human exposure
or environmental release, and a ban of the chemical substance 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>.
Authority: 15 U.S.C. 2601 et seq.
Dated: August 28, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-19698 Filed 8-30-24; 8:45 am]
BILLING CODE 6560-50-P
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