Di-isononyl phthalate (DINP); Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability, Webinar and Request for Comment, 71270-71272 [2024-19698]
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71270
Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices
San Fernando Valley Basin-Wide
Remedial Investigation response costs
from other responsible parties in the
future; however, because EPA is not
recovering one hundred percent of its
past costs at this time, this Settlement
Agreement represents a compromise of
EPA’s costs. The Settlement Agreement
includes two covenants not to sue
pursuant to sections 106 and 107(a) of
CERCLA, 42 U.S.C. 9606 and 9607(a).
EPA will consider all comments
received on the Settlement Agreement
in accordance with the DATES and
ADDRESSES sections of this Notice and
may modify or withdraw its consent to
the Settlement Agreement if comments
received disclose facts or considerations
that indicate that the settlement is
inappropriate, improper, or inadequate.
Parties to the Proposed Settlement:
Coltec Industries, Inc., Menasco
Aerosystems Division; Eaton Filtration
LLC, as successor in interest to Vickers
Incorporated; Foto-Kem Industries, Inc.;
Haskel International, LLC, formerly
Haskel International, Inc.; International
Electronic Research Corporation; ITT
LLC, as successor in interest to ITT
Industries, Inc.; Lockheed Martin
Corporation; Lockheed Martin
Librascope Corporation; Pacific Bell
Telephone Company, formerly Pacific
Bell, formerly The Pacific Telephone
and Telegraph Company; Philips North
America LLC, as successor in interest to
Philips Components, a Division of
Philips Electronics North America
Corporation; PRC-DeSoto International,
Inc., formerly Courtaulds Aerospace,
Inc.; The Prudential Insurance Company
of America; Ralphs Grocery Co.; Union
Pacific Railroad Company, formerly
Southern Pacific Transportation Co.;
Vorelco, Inc.; and Walt Disney Pictures
and Television.
Dated: August 27, 2024.
Dana Barton,
Acting Director, Superfund and Emergency
Management Division, EPA Region 9.
[FR Doc. 2024–19708 Filed 8–30–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
tkelley on LAP7H3WLY3PROD with NOTICES2
[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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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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, 1,2diisononyl 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
https://usepa.zoomgov.com/meeting/
register/vJIsc-mprzguHuiI1Lu5jNuwkQ84wPrRr8.
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 https://
www.regulations.gov. 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
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Webinar information: Sarah Soliman,
Project Management and Operations
SUMMARY:
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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: soliman.sarah@
epa.gov.
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:
coleman.todd@epa.gov.
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:
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
U:\REGISTER\03SEN1.SGM
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Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices
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 nonrisk 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
https://www.regulations.gov or email. If
you wish to include CBI in your
comment, please follow the applicable
instructions at https://www.epa.gov/
dockets/commenting-epa-dockets#rules
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
https://www.epa.gov/dockets/
commenting-epa-dockets.
II. Background
tkelley on LAP7H3WLY3PROD with NOTICES2
A. What is DINP?
DINP is a common chemical name for
the category of chemical substances that
includes the following substances: 1,2benzenedicarboxylic acid, 1,2-isononyl
ester (CASRN 28553–12–0) and 1,2benzenedicarboxylic acid, di-C9-11branched 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, 1,2diisodecyl 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 physicalchemical (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.
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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 noncancer 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 noncancer 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
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evaluation, EPA’s protective, screeninglevel 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 nongovernmental 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:
• Sections 3, 4 and 5 of the Draft Risk
Evaluation for DINP;
• Draft Environmental Release and
Occupational Exposure Assessment for
DINP;
• Draft Consumer and Indoor
Exposure Assessment for DINP;
• Draft Environmental Media and
General Population Screening for DINP;
• Draft Environmental Exposure
Assessment for DINP;
• 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.
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Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices
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 https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca.
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
ENVIRONMENTAL PROTECTION
AGENCY
tkelley on LAP7H3WLY3PROD with NOTICES2
[EPA R9–2024–01; FRL–12107–01–R9]
Notice of Proposed Administrative
Settlement Agreement and Order on
Consent for Removal Actions and
Recovery of Past Response Costs at
the Max Johnson No. 9, Manuel
Denetsone No. 2, and Juan Horse No.
3 Abandoned Uranium Mine Sites,
Navajo Nation, Coconino County,
Arizona
Environmental Protection
Agency (EPA).
AGENCY:
VerDate Sep<11>2014
22:46 Aug 30, 2024
Notice of proposed settlement;
request for public comment.
ACTION:
Jkt 262001
In accordance with the
Comprehensive Environmental
Response, Compensation and Liability
Act of 1980, as amended (‘‘CERCLA’’),
notice is hereby given that the
Environmental Protection Agency
(‘‘EPA’’) has entered into a proposed
settlement, embodied in an
Administrative Settlement Agreement
and Order on Consent (‘‘Settlement
Agreement’’), with Wells Cargo, Inc.
(‘‘Wells Cargo’’). Under the Settlement
Agreement, Wells Cargo agrees to take
response actions and pay a portion of
EPA’s past response costs at the Max
Johnson No. 9, Manuel Denetsone No. 2,
and Juan Horse No. 3 abandoned
uranium mine sites (‘‘Sites’’) in the
Navajo Nation in Coconino County,
Arizona.
DATES: Comments must be received on
or before October 3, 2024.
ADDRESSES: The proposed settlement
agreement is available for public
inspection at https://insert link.
Comments on the Settlement Agreement
should be submitted in writing to
Gregory Krauss at krauss.gregory@
epa.gov. Comments should reference the
Wells Cargo Sites and Docket No. 2024–
01, the EPA Region 9 Docket Number for
the Settlement Agreement. If for any
reason you are not able to submit a
comment by email, please contact Mr.
Krauss at (415) 972–3913 to make
alternative arrangements for submitting
your comment. EPA will post its
response to any comments at https://
www.epa.gov/navajo-nation-uraniumcleanup/western-abandoned-uraniummine-region, EPA’s website for the
Western Abandoned Uranium Mine
Region in the Navajo Nation.
FOR FURTHER INFORMATION CONTACT:
Gregory Krauss, Assistant Regional
Counsel (ORC–3), Office of Regional
Counsel, U.S. EPA Region IX, 75
Hawthorne Street, San Francisco, CA
94105; Email: krauss.gregory@epa.gov;
Phone (415) 972–3913.
SUPPLEMENTARY INFORMATION: Notice of
this proposed administrative settlement
is made in accordance with section
122(i) of CERCLA. The Settlement
Agreement concerns the performance of
response actions at the Sites and the
recovery by EPA of past response costs.
The Settlement Agreement requires
Wells Cargo to perform removal site
evaluations at the Max Johnson No. 9
and Manuel Denetsone No. 2 mines,
conduct certain sampling at the Juan
Horse No. 3 mine, and complete an
Engineering Evaluation and Cost
Analysis for each of the Sites as
SUMMARY:
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determined to be necessary by EPA.
Wells Cargo will also pay $391,183.15 to
resolve its liability for EPA’s past
response costs through March 31, 2019.
The Settlement Agreement includes a
compromise of around $75,000 on
interest payments and some indirect
costs and provides Wells Cargo
contribution protection and a covenant
not to sue regarding response costs
incurred through March 31, 2019, and
the work to be performed. EPA will
consider all comments received on the
Settlement Agreement in accordance
with the DATES and ADDRESSES sections
of this Notice and may modify or
withdraw its consent to the Settlement
Agreement if comments received
disclose facts or considerations that
indicate that the settlement is
inappropriate, improper, or inadequate.
Dated: August 27, 2024.
Will Duncan,
Acting Director, Superfund and Emergency
Management Division, EPA Region 9.
[FR Doc. 2024–19709 Filed 8–30–24; 8:45 am]
BILLING CODE 6560–50–P
FARM CREDIT ADMINISTRATION
Sunshine Act Meetings
10 a.m., Thursday,
September 12, 2024.
PLACE: You may observe this meeting in
person at 1501 Farm Credit Drive,
McLean, Virginia 22102–5090, or
virtually. If you would like to observe,
at least 24 hours in advance, visit
FCA.gov, select ‘‘Newsroom,’’ then
select ‘‘Events.’’ From there, access the
linked ‘‘Instructions for board meeting
visitors’’ and complete the described
registration process.
STATUS: This meeting will be open to the
public.
MATTERS TO BE CONSIDERED: The
following matters will be considered:
• Approval of Minutes for August 8,
2024
• Quarterly Report on Economic
Conditions and Farm Credit System
Condition and Performance
CONTACT PERSON FOR MORE INFORMATION:
If you need more information or
assistance for accessibility reasons, or
have questions, contact Ashley
Waldron, Secretary to the Board.
Telephone: 703–883–4009. TTY: 703–
883–4056.
TIME AND DATE:
Ashley Waldron,
Secretary to the Board.
[FR Doc. 2024–19798 Filed 8–29–24; 11:15 am]
BILLING CODE 6705–01–P
U:\REGISTER\03SEN1.SGM
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Agencies
[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71270-71272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
-----------------------------------------------------------------------
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 https://usepa.zoomgov.com/meeting/register/vJIsc-mprzguHuiI1Lu5jNuwk-Q84wPrRr8.
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 https://www.regulations.gov. 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 https://www.epa.gov/dockets.
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:
[email protected].
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:
[email protected].
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 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 https://www.regulations.gov or
email. If you wish to include CBI in your comment, please follow the
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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 https://www.epa.gov/dockets/commenting-epa-dockets.
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:
Sections 3, 4 and 5 of the Draft Risk Evaluation for DINP;
Draft Environmental Release and Occupational Exposure
Assessment for DINP;
Draft Consumer and Indoor Exposure Assessment for DINP;
Draft Environmental Media and General Population Screening
for DINP;
Draft Environmental Exposure Assessment for DINP;
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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.
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