[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.

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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 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.

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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]
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