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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1125-1127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00137]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0504; FRL-12481-01-OCSPP]

Dicyclohexyl phthalate (DCHP); Draft Risk Evaluation Under the 
Toxic Substances Control Act (TSCA); Notice of Availability 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 
Dicyclohexyl phthalate (DCHP) (1,2-benzenedicarboxylic acid, 1,2-
dicyclohexyl ester) (CASRN 84-61-7). 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 other 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 draft risk evaluation and to preliminarily determine that DCHP 
poses unreasonable risk to human health.

DATES: Comments must be received on or before March 10, 2025.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0504, 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: 
    Chemical specific information: Claire Brisse, 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) 564-9004; 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.

[[Page 1126]]

15 U.S.C. 2625(h), (i), and (k). See also the implementing procedural 
regulations at 40 CFR part 702. 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 and seeking public comment on 
a draft risk evaluation under TSCA for DCHP (CASRN 84-61-7). 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. 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 DCHP 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 DCHP?

    DCHP is a common chemical name for the chemical substance 1,2-
benzenedicarboxylic acid, 1,2-dicyclohexyl ester (CASRN 84-61-7). DCHP 
is a granular solid at room temperature that is produced by the 
esterification of phthalic anhydride with cyclohexanols. It is 
primarily used as a plasticizer in adhesives and plastic and rubber 
products and resins for consumer, commercial, and industrial 
applications.

B. Why is EPA evaluating this chemical under TSCA?

    In December 2019, EPA announced its designation of DCHP as a high-
priority substance for risk evaluation under TSCA (Ref. 1). A draft 
scope of the DCHP risk evaluation was published in April 2020 (Ref. 2), 
and after receiving public comment, EPA issued the final scope of the 
DCHP risk evaluation in September 2020 (Ref. 3).
    The Agency has evaluated the health and environmental risks of DCHP 
under TSCA section 6. Laboratory animal data suggest that developmental 
toxicity, specifically androgen insufficiency (phthalate syndrome), is 
the most sensitive and robust non-cancer hazard for DCHP. The Agency 
included DCHP for cumulative risk assessment along with five other 
phthalate chemicals that also cause effects on laboratory animals 
consistent with phthalate syndrome (Ref. 4). Notably, assessments by 
Health Canada, U.S. CPSC, European Chemicals Agency (ECHA), and the 
Australian National Industrial Chemicals Notification and Assessment 
Scheme (NICNAS) have reached similar conclusions regarding the effects 
of DCHP on development and have also conducted cumulative risk 
assessments of phthalates based on these chemicals' shared ability to 
cause phthalate syndrome. Further, independent, expert peer reviewers 
endorsed EPA's proposal to conduct a cumulative risk assessment of 
phthalates under TSCA during the May 2023 meeting of the Science 
Advisory Committee on Chemicals (SACC) because doing so represents the 
best available science. In this draft risk evaluation, EPA has 
evaluated cumulative exposure to phthalates for the U.S. civilian 
population using human biomonitoring data. These phthalate exposures to 
the general U.S. civilian population cannot be attributed to specific 
conditions of use or other sources. This non-attributable cumulative 
exposure and risk, representing that of the national population, was 
taken into consideration by EPA in reaching its preliminary 
determination of unreasonable risk of injury of human health for DCHP. 
Had EPA not taken this into consideration, it could have understated 
the unreasonable risk of injury to human health for DCHP.
    In this draft risk evaluation, EPA has preliminarily determined 
that DCHP presents an unreasonable risk of injury to human health under 
the conditions of use (COUs). Of the 24 COUs that EPA evaluated, 9 COUs 
have risk estimates that raise concerns for workers' exposure to DCHP, 
and no COUs that raise such concerns for consumers or the general 
population. In its draft evaluation, EPA's protective, screening-level 
approaches demonstrated that DCHP does not pose risk to the 
environment.
    After this draft risk evaluation is informed by public comment and 
independent, expert peer review advice, EPA will issue a final risk 
evaluation that includes its determination as to whether DCHP presents 
unreasonable risk to health or the environment under the TSCA COUs. EPA 
also continues to work on the draft risk evaluations of five additional 
high-priority chemical substance 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.

IV. Next Steps

    In its risk evaluation, EPA must determine whether the chemical 
presents an unreasonable risk to health or the environment under the 
chemical's conditions of use. These factors include risks to 
subpopulations who may be at greater exposure or susceptibility than 
the general population, such as children and workers. TSCA prohibits 
EPA from considering non-risk factors (e.g., costs/benefits) in making 
its risk determination.
    If 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 so the chemical substance no longer 
presents an 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

[[Page 1127]]

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. High-Priority Substance Designations Under the Toxic 
Substances Control Act (TSCA) and Initiation of Risk Evaluation on 
High-Priority Substances; Notice of Availability. Federal Register. 
84 FR 71924, December 30, 2019 (FRL-10003-15).
    2. EPA. Draft Scopes of the Risk Evaluations To Be Conducted for 
Seven Chemical Substances Under the Toxic Substances Control Act; 
Notice of Availability. Federal Register. 85 FR 22733, April 23, 
2020 (FRL-10008-05).
    3. EPA. Final Scopes of the Risk Evaluations To Be Conducted for 
Twenty Chemical Substances Under the Toxic Substances Control Act; 
Notice of Availability. Federal Register. 85 FR 55281, September 4, 
2020 (FRL-10013-90).
    4. EPA. Cumulative Risk Assessment Under the Toxic Substances 
Control Act. EPA website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/cumulative-risk-assessment-under-toxic-substances#.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: December 30, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2025-00137 Filed 1-6-25; 8:45 am]
BILLING CODE 6560-50-P
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