[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]
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