[Federal Register Volume 90, Number 107 (Thursday, June 5, 2025)]
[Notices]
[Pages 23931-23932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10200]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0503 and EPA-HQ-OPPT-2018-0433; FRL-12808-01-OCSPP]
Dibutyl Phthalate (DBP) and Diethylhexyl Phthalate (DEHP); Draft
Risk Evaluations 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 the draft
risk evaluations under the Toxic Substances Control Act (TSCA) for
Dibutyl Phthalate (DBP) (CASRN 84-74-2) and Diethylhexyl Phthalate
(DEHP) (CARSN 117-81-7). 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 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 draft risk evaluation and to
preliminarily determine, based on the weight of scientific evidence,
that DBP and DEHP present unreasonable risk to health and the
environment driven primarily by certain conditions of use analyzed in
the draft evaluations.
DATES: Comments must be received on or before August 4, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0503, 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:
For technical information on DBP: Carolyn Mottley, 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) 566-1955; email address: [email protected].
For technical information on DEHP: Dyllan Taylor, 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) 564-2913; 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 DBP and DEHP, 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
appropriate 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 the 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,
and not consider costs or non-risk factors. 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
these draft risk evaluations conducted under TSCA for DBP and DEHP. The
purpose of risk evaluation 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 draft risk evaluation and, based on the weight of
scientific evidence, to preliminarily determine that DBP and DEHP
present unreasonable risk to health and the environment driven
primarily by certain conditions of use analyzed in the draft
evaluations.
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 are DBP and DEHP?
DBP is a common chemical name for the chemical substance 1,2-
Benzenedicarboxylic acid, 1,2-dibutylester (CASRN 84-74-2). DEHP is a
common chemical name for the chemical substance 1,2-Benzenedicarboxylic
acid, 1,2-bis(2-ethylhexyl) ester (CASRN 117-81-7). DBP and DEHP are
manufactured (including imported), processed, distributed, and disposed
as part of industrial, commercial, and consumer conditions of use. DBP
and DEHP are used primarily as plasticizers in polyvinyl chloride
(PVC). These phthalates are also used in adhesives, sealants, paints,
coatings, rubbers, and
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non-PVC plastics, as well as for other applications. Between 2016 and
2019 the productions volumes of DBP and DEHP were between 1 to 10
million pounds and between 10 to 50 million pounds, respectively, based
on the 2020 TSCA Chemical Data Reporting data.
B. Summary of Activities for the Risk Evaluations of DBP and DEHP
In December 2019, EPA announced its designation of DBP and DEHP as
high priority substances for risk evaluation under TSCA (Ref. 1). In
June 2020, EPA sought public comment on the draft scopes of the DBP and
DEHP risk evaluations (Ref. 2), and, after considering public comments,
issued the final scope in September 2020 (Ref. 3). These documents,
other supporting documents, and public comments are in the docket
established for each chemical at https://www.regulations.gov. In
addition, as will be announced separately in the Federal Register, the
draft risk evaluations for DBP and DEHP will also undergo peer review
by the Science Advisory Committee on Chemicals (SACC) and will be
included in the SACC peer review docket (Docket ID No. EPA-HQ-OPPT-
2024-0551), along with other materials related to that peer review.
III. Request for Comment
EPA seeks feedback on the assessment of risk presented in the draft
risk evaluations for DBP (Docket ID No. EPA-HQ-OPPT-2018-0503) and DEHP
(Docket ID No. EPA-HQ-OPPT-2018-0433), which are available in the
chemical specific dockets as identified, 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 evaluations. To the extent possible, the
Agency asks commenters to please cite any public data related to or
that support comments provided, and to the extent permissible, describe
any supporting data that are not publicly available.
EPA welcomes specific input on each section of the draft risk
evaluation for each chemical, and is particularly interested in
comments and information related to the following topics:
Information on the use of personal protective equipment
(PPE) and engineering controls during the manufacture, processing, and
use of DBP and DEHP for each condition of use.
Information that could be used to replace upper-bound or
screening level assumptions, particularly for the conditions of use
that may significantly contribute to unreasonable risk;
Application of the Revised Draft Technical Support
Document for the Cumulative Risk Analysis (CRA) within the individual
chemical risk evaluations;
The use of transcriptomics data in the weight of
scientific evidence for environmental hazard assessment of DBP and the
environmental hazard assessment of DEHP;
The human health and environmental hazard endpoints used
in the risk characterizations;
Application of a flux-limited approach to estimating
dermal absorption; and
Approaches used to estimate chemical migration rate for
ingestion via mouthing in the consumer exposure assessments.
IV. Next Steps
After consideration of comments received from the public and the
SACC on the draft risk evaluations, EPA will issue final risk
evaluations for DBP and DEHP. A separate forthcoming Federal Register
notice will announce the peer review by the SACC.
Under TSCA section 6, EPA must determine in the final risk
evaluations, based on the weight of scientific evidence, whether or not
the chemicals present an unreasonable risk to health or the environment
under the chemical's conditions of use. This includes consideration of
risks to potentially exposed susceptible subpopulations (PESS) who may
be at greater risks than the general population, such as children and
workers. TSCA prohibits EPA from considering non-risk factors (e.g.,
costs/benefits) during risk evaluation.
If EPA determines that a chemical presents an unreasonable risk to
health or the environment, the chemical will move to risk management
action under TSCA section 6(a) for the relevant conditions of use. EPA
is required to implement, via regulation, regulatory restrictions on
the manufacture (including import), processing, distribution, use or
disposal of the chemical to eliminate the identified 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 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.
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).
Authority: 15 U.S.C. 2601 et seq.
Dated: May 30, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and
Pollution Prevention.
[FR Doc. 2025-10200 Filed 6-4-25; 8:45 am]
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