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[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Pages 3828-3830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00730]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0436; FRL-8806-04-OCSPP]

Diisononyl Phthalate (DINP); Risk Evaluation Under the Toxic 
Substances Control Act; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is 
announcing the availability of the final risk evaluation under the 
Toxic Substances Control Act (TSCA) for diisononyl 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 under the conditions of use, including 
unreasonable risk to potentially exposed or susceptible subpopulations 
identified as relevant to the risk evaluation by EPA, and without 
consideration of costs or non-risk factors. EPA used the best available 
science to prepare this final risk evaluation and determined, based on 
the weight of scientific evidence, that DINP 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-2018-0436, 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: 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].
    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 (defined under 
TSCA section 3(9) to include import), processing, distribution, use, 
and disposal of DINP, 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 and for more information about the TSCA risk evaluation process for 
existing chemicals, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.

C. What action is the Agency taking?

    EPA is announcing the availability of the final risk evaluation 
under TSCA for DINP. 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 under the conditions of use, 
including unreasonable risk to potentially exposed or susceptible 
subpopulations identified as relevant to the risk evaluation by EPA, 
and without consideration of costs or non-risk factors. EPA has used 
the best available science to prepare this final risk evaluation and, 
based on the weight of scientific evidence, determined that DINP poses 
unreasonable risk to human health. Upon a determination of unreasonable 
risk, EPA must initiate risk management action as required

[[Page 3829]]

pursuant to TSCA section 6(a), 15 U.S.C 2605(a), to address the 
unreasonable risk.

II. Background

A. What is DINP?

    DINP is a common chemical name for the category of chemical 
substances that includes the following substances: Di-isononyl 
phthalate (DINP) (1,2-Benzene- dicarboxylic acid, 1,2- diisononyl 
ester) (CASRN 28553-12-0 and 68515-48-0). Both CASRNs contain mainly C9 
dialkyl phthalate esters. DINP is manufactured (including imported), 
processed, distributed, and disposed as part of industrial, commercial, 
and consumer conditions of use. DINP 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. DINP 
production volumes are available through the TSCA Chemical Data 
Reporting (CDR) rule under two associated CAS Registry Numbers 
(CASRNs): 1) The production volume for CASRN 28553-12-0 in 2015 was 
between 100 to 250 million pounds (lb.) and decreased to 50 to 100 
million lb. in 2019 based on the latest 2020 CDR data; and 2) The 
production volume for CASRN 68515-48-0 in 2015 ranged between 100 to 
250 million lb. and changed to between 100 million and 1 billion lb. in 
2019 based on the latest 2020 CDR data.

B. Summary of Activities for the Risk Evaluation of DINP

    In May 2019, EPA received a request to conduct a risk evaluation 
for DINP 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 (Ref. 1). In 
November 2020, EPA released the draft scope of the DINP risk evaluation 
(Ref. 2), and, after receiving public comments, issued the problem 
formulation in August 2021 (Ref. 3). In May 2024, the Environmental 
Hazard and Human Health Hazard technical support documents for DINP 
were released for public comment and peer review by the Science 
Advisory Committee on Chemicals (SACC) (Ref. 4). In September 2024, EPA 
released a full draft risk evaluation for public comment (Ref. 5). The 
draft documents and public comments are in docket ID number EPA-HQ-
OPPT-2024-0436.
    The docket also includes a response to comments document (Ref. 6), 
a non-technical summary of the final risk evaluation (Ref. 7), and the 
final risk evaluation (Ref. 8).

III. Unreasonable Risk Determination

    EPA has determined that DINP presents an unreasonable risk of 
injury to human health under the COUs. EPA did not identify risk of 
injury to the environment that would contribute to the unreasonable 
risk determination for DINP. EPA has determined that the unreasonable 
risk to human health presented by DINP is due to the following: (1) 
Non-cancer effects (developmental toxicity) in female workers of 
reproductive age from acute inhalation exposures; (2) Non-cancer 
effects (liver effects) in female workers of reproductive age from 
chronic aggregate exposures; and (3) Non-cancer effects (liver effects) 
in workers from chronic and aggregate exposures. This unreasonable risk 
determination is based on the information in 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.
    The COUs that EPA identified as significantly contributing to the 
unreasonable risk from DINP include those that lead to exposures to 
average adult workers, including female workers of reproductive age, in 
scenarios in which unprotected workers used spray adhesives and 
sealants or paints and coatings that contain DINP, because doing so 
could create high concentrations of DINP in mist that an unprotected 
worker could inhale.
    Between release of the draft risk evaluation and finalization of 
the DINP risk evaluation, EPA updated the risk determination to find 
that four conditions of use (COUs) significantly contribute to the 
unreasonable risk of DINP. These updates were based on new information 
identified by EPA, information provided by public commenters, and 
recommendations of the Science Advisory Committee on Chemicals (SACC). 
These changes stem from consideration of (1) multiple factors impacting 
occupational exposure during spray application; and (2) determination 
that the liver effects associated with chronic exposure are relevant to 
adult works, adult consumers, and adult members of the general 
population, but not infants and children.

IV. Next Step Is Risk Management

    Consistent with TSCA section 6(a), EPA will propose a risk 
management regulatory action to the extent necessary so that DINP no 
longer presents an unreasonable risk. EPA expects to focus its risk 
management action on the COUs 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 TSCA 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., consumer 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.

V. 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-isononyl Phthalate (DINP); Manufacturer Request for 
Risk Evaluation Under the Toxic Substances Control Act (TSCA). 
Federal Register. 84 FR 42912, August 19, 2019 (FRL-9998-25-OCSPP).
    2. EPA. Di-isononyl Phthalate (DINP); 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 76072, November 27, 2020 (FRL-10017-15-OSCPP).
    3. EPA. Di-isononyl Phthalate (DINP); Final Scope of the Risk 
Evaluation To Be Conducted Under the Toxic Substances Control Act 
(TSCA); Notice of Availability. Federal Register. 86 FR 48693, 
August 31, 2021 (FRL- 8806-01-OSCPP).
    4. EPA. Di-isodecyl Phthalate (DIDP) and Di-isononyl Phthalate 
(DINP); Science Advisory Committee on Chemicals (SACC) Peer Review 
of Draft Documents; Notice of

[[Page 3830]]

SACC Meeting; Availability; and Request for Comment. Federal 
Register. 89 FR 43847, May 20, 2024 (FRL-11760-02-OCSPP).
    5. EPA. Di-isononyl phthalate (DINP); Draft Risk Evaluation 
Under the Toxic Substances Control Act (TSCA); Notice of 
Availability, Webinar and Request for Comment. Federal Register. 89 
FR 71270, September 3, 2024 (FRL-8806-02-OCSPP).
    6. EPA. Comment Summary and Responses for Di-isodecyl Phthalate 
(DIDP) and Diisononyl Phthalate (DINP). December 2024.
    7. EPA. Nontechnical Summary of the TSCA Risk Evaluation for Di-
isononyl Phthalate (DINP). December 2024. (EPA Publication ID No. 
EPA-740-S-25-001).
    8. EPA. TSCA Risk Evaluation for Di-isononyl Phthalate (DINP). 
December 2024. (EPA Publication ID No. EPA-740-R-25-001).
    Authority: 15 U.S.C. 2601 et seq.

    Dated: January 7, 2025.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2025-00730 Filed 1-14-25; 8:45 am]
BILLING CODE 6560-50-P
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