[Federal Register Volume 91, Number 3 (Tuesday, January 6, 2026)]
[Notices]
[Pages 373-375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-24290]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0501, EPA-HQ-OPPT-2018-0503, EPA-HQ-OPPT-2018-0504,
EPA-HQ-OPPT-2018-0433, EPA-HQ-OPPT-2018-0434, EPA-HQ-OPPT-2024-0551;
FRL-13111-01-OCSPP]
Butyl Benzyl Phthalate (BBP), Dibutyl Phthalate (DBP),
Dicyclohexyl Phthalate (DCHP), Diethylhexyl Phthalate (DEHP), and
Diisobutyl Phthalate (DIBP); Risk Evaluation under the Toxic Substances
Control Act (TSCA); 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 evaluations under the
Toxic Substances Control Act (TSCA) for Butyl Benzyl Phthalate (BBP)
(CARSN 85-68-7), Dibutyl Phthalate (DBP) (CASRN 84-74-2), Dicyclohexyl
Phthalate (DCHP) (CASRN 84-61-7), Diethylhexyl Phthalate (DEHP) (CASRN
117-81-7), and Diisobutyl Phthalate (DIBP) (CASRN 84-69-5). The purpose
of conducting 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. EPA used the best available science to
prepare these final risk evaluations, and determined, based on the
weight of scientific evidence, that BBP, DBP, DCHP, DEHP, and DIBP pose
unreasonable risk to human health and/or the environment driven by
specific conditions of use. Under TSCA, EPA must initiate risk
management actions to address the unreasonable risk.
ADDRESSES: The dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPPT-2018-0501, EPA-HQ-OPPT-2018-
0503, EPA-HQ-OPPT-2018-0504, EPA-HQ-OPPT-2018-0433, and EPA-HQ-OPPT-
2018-0434 are 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 on BBP: Brianne Raccor, 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) 564-0303; email
address: [email protected].
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 DCHP: 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].
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 technical information on DIBP: Stephen Watkins, 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) 564-3744; email address: [email protected].
For general information: The TSCA-Hotline, Goodwill Vision
Enterprises, 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 BBP, DBP, DCHP, DEHP, and DIBP, 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
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action might apply to. If you need help determining applicability,
consult the BBP, DBP, DCHP, DEHP, or DIBP technical contact listed
under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
The Agency conducted these risk evaluations 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, 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 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 evaluations
under TSCA for BBP, DBP, DCHP, DEHP, and DIBP. 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 and ensured that this
action is consistent with Executive Order 14303 ``Restoring Gold
Standard Science,'' (May 23, 2025). Based on the weight of scientific
evidence, the Agency determined that BBP, DBP, DCHP, DEHP, and DIBP
pose unreasonable risk to human health and/or the environment driven by
specific conditions of use. EPA will now initiate risk management
action as required pursuant to TSCA section 6(a) (15 U.S.C 2605(a)), to
address the unreasonable risk.
II. Background
A. What are BBP, DBP, DCHP, DEHP, and DIBP?
BBP is a common chemical name for the chemical substance 1,2-
Benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester (CASRN 85-68-
7). DBP is a common chemical name for the chemical substance 1,2-
Benzenedicarboxylic acid, 1,2-dibutylester (CASRN 84-74-2). DCHP is a
common chemical name for the chemical substance 1,2-benzenedicarboxylic
acid, 1,2-dicyclohexyl ester (CASRN 84-61-7). DEHP is a common chemical
name for the chemical substance 1,2-Benzenedicarboxylic acid, 1,2-
bis(2-ethylhexyl) ester (CASRN 117-81-7). DIBP is a common chemical
name for the chemical substance 1,2-Benzenedicarboxylic acid, 1,2-
bis(2-methylpropyl) ester (CASRN 84-69-5). BBP, DBP, DCHP, DEHP, and
DIBP are manufactured (including imported), processed, distributed, and
disposed of as part of industrial, commercial, and consumer conditions
of use. These phthalates are used as plasticizers in polyvinyl chloride
(PVC) and non-PVC plastics, as well as in adhesives, sealants, paints,
coatings, rubbers, and other applications. Between 2016 and 2019,
annual production volumes of these phthalates were reported to be
between 1 and 20 million pounds (BBP), between 1 and 10 million pounds
(DBP), between 500 thousand and 1 million pounds (DCHP), between 10 and
50 million pounds (DEHP), and between 380,000 and 441,000 pounds (DIBP)
based on the 2020 TSCA Chemical Data Reporting (CDR) data.
B. Summary of Activities for the Risk Evaluations of BBP, DBP, DCHP,
DEHP, and DIBP
On December 30, 2019, EPA announced its designation of BBP, DBP,
DCHP, DEHP, and DIBP as high-priority substances for risk evaluation
under TSCA (84 FR 71924) (FRL-10003-1). On April 23, 2020, EPA sought
public comment on the draft scopes of the BBP, DBP, DCHP, DEHP, and
DIBP risk evaluations (85 FR 22733) (FRL-10008-05), and, after
considering public comments, issued the final scopes on September 4,
2020, (85 FR 55281) (FRL-10013-90). The Science Advisory Committee on
Chemicals (SACC) conducted an external peer review of the proposed
approach for cumulative risk assessment of these phthalates on May 8,
2023, through May 11, 2023 (88 FR 3974) (FRL-10490-02). On January 7,
2025, EPA sought public comment on the draft risk evaluation of DCHP
(90 FR 1125) (FRL-12481-01). On June 5, 2025, EPA sought public comment
on the draft risk evaluation of DBP and DEHP (90 FR 23931) (FRL-12808-
01-OCSPP). On August 6, 2025, EPA sought public comment on the draft
risk evaluation of BBP and DIBP (90 FR 14882) (FRL-12897-01-OCSPP). On
August 4, 2025, through August 8, 2025, the SACC conducted an external
peer review of the draft risk evaluations for DBP, DCHP, and DEHP, as
well as the hazard assessments for BBP and DIBP (90 FR 24400) (FRL-
12418-02-OCSPP). For more information about these SACC meetings, go to
the SACC website at https://www.epa.gov/tsca-peer-review/science-advisory-committee-chemicals-meetings.
These documents, other supporting documents, and public comments
are in the dockets EPA-HQ-OPPT-2018-0501 (BBP), EPA-HQ-OPPT-2018-0503
(DBP), EPA-HQ-OPPT-2018-0504 (DCHP), EPA-HQ-OPPT-2018-0433 (DEHP), EPA-
HQ-OPPT-2018-0434 (DIBP), EPA-HQ-OPPT-2022-0918 (SACC 2023), and EPA-
HQ-OPPT-2024-0551 (SACC 2025). The following documents are also being
released with this notice:
1. A response to public comments document titled, ``Response to
Public Comments on the Draft Risk Evaluations for Butyl Benzyl
Phthalate (BBP); Dibutyl Phthalate (DBP); Dicyclohexyl Phthalate
(DCHP); Diethylhexyl Phthalate (DEHP); and Diisobutyl Phthalate
(DIBP): EPA-HQ-OPPT-2018-0501; EPA-HQ-OPPT-2018-0503; EPA-HQ-OPPT-
2018-0504; EPA-HQ-OPPT-2018-0433; EPA-HQ-OPPT-2018-0434; EPA-HQ-
OPPT-2022-0918; and EPA-HQ-OPPT-2024-0551;''
2. A response to peer review comments document titled, ``Summary
of and Response to External Peer Review on the Risk Evaluations and
Technical Support Documents for Di(2-ethylhexyl) Phthalate (DEHP),
Dibutyl Phthalate (DBP), Butyl Benzyl Phthalate (BBP), Diisobutyl
Phthalate (DIBP), Dicyclohexyl Phthalate (DCHP), and Diisononyl
Phthalate (DINP)''
3. A non-technical summary of the final risk evaluation for BBP
titled, ``Nontechnical Summary of the TSCA Risk Evaluation for Butyl
Benzyl Phthalate;''
4. A non-technical summary of the final risk evaluation for DBP
titled, ``Nontechnical Summary of the TSCA Risk Evaluation for
Dibutyl Phthalate;''
5. A non-technical summary of the final risk evaluation for DCHP
entitled, ``Nontechnical Summary of the TSCA Risk Evaluation for
Dicyclohexyl Phthalate;''
6. A non-technical summary of the final risk evaluation for DEHP
entitled, ``Nontechnical Summary of the TSCA Risk Evaluation for
Diethylhexyl Phthalate;''
7. A non-technical summary of the final risk evaluation for DIBP
entitled, ``Nontechnical Summary of the TSCA Risk Evaluation for
Diisobutyl Phthalate;''
8. The final risk evaluation for BBP entitled, ``Risk Evaluation
for Butyl Benzyl Phthalate;''
9. The final risk evaluation for DBP entitled, ``Risk Evaluation
for Dibutyl Phthalate;''
10. The final risk evaluation for DCHP entitled, ``Risk
Evaluation for Dicyclohexyl Phthalate;''
11. The final risk evaluation for DEHP entitled, ``Risk
Evaluation for Diethylhexyl Phthalate;'' and
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12. The final risk evaluation for DIBP entitled, ``Risk
Evaluation for Diisobutyl Phthalate.''
III. Unreasonable Risk Determination
EPA determined that BBP presents an unreasonable risk of injury to
human health and the environment driven by 7 of the 38 conditions of
use (COUs). EPA has determined that the unreasonable risk to human
health presented by BBP is driven by 2 COUs based on non-cancer risks
associated with inhalation exposure to workers. The unreasonable risk
to the environment is driven by 7 COUs due to chronic exposure of
aquatic organisms through surface water. EPA did not identify
unreasonable risk of injury to consumers or the general population
under any COUs for BBP, nor do cumulative exposures contribute to
unreasonable risks.
EPA determined that DBP presents an unreasonable risk of injury to
human health and the environment driven by 6 of the 44 COUs. EPA has
determined that the unreasonable risk to human health presented by DBP
is driven by 5 COUs based on non-cancer risks driven by inhalation and
aggregate exposure to workers. The unreasonable risk to the environment
is driven by 1 COU due to chronic exposure of aquatic vertebrates, and
exposure of aquatic plants and algae, through surface water. EPA did
not identify unreasonable risk of injury to consumers or the general
population under any COUs for DBP, nor do cumulative exposures
contribute to unreasonable risks.
EPA determined that DCHP presents an unreasonable risk of injury to
human health driven by 2 of the 24 COUs. EPA has determined that the
unreasonable risk to human health presented by DCHP is driven by 2 COUs
based on non-cancer risks associated with acute inhalation exposures to
workers. EPA did not identify unreasonable risk to the environment
under any COUs. EPA did not identify unreasonable risk of injury to
consumers or the general population under any COUs for DCHP, nor do
cumulative exposures contribute to unreasonable risks.
EPA determined that DEHP presents an unreasonable risk of injury to
human health and the environment driven by 20 of the 44 COUs. EPA has
determined that the unreasonable risk to human health presented by DEHP
is driven by 10 COUs based on non-cancer risks associated with exposure
to workers. The unreasonable risk to the environment is driven by 20
COUs due to chronic exposure of aquatic organisms through surface water
with a subset of 18 of these COUs also driven by risk due to chronic
exposure of sediment-dwelling organisms through sediment pore water.
EPA did not identify unreasonable risk of injury to consumers or the
general population under any COUs for DEHP, nor do cumulative exposures
contribute to unreasonable risks.
EPA determined that DIBP presents an unreasonable risk of injury to
human health and the environment driven by 9 of the 28 COUs. EPA has
determined that the unreasonable risk to human health presented by DIBP
is driven by 4 COUs based on non-cancer risks associated with
inhalation exposure to workers. The unreasonable risk to the
environment is driven by 7 COUs due to exposure of algae and chronic
exposure of aquatic vertebrates through surface water. EPA did not
identify unreasonable risk of injury to consumers or the general
population under any COUs for DIBP, nor do cumulative exposures
contribute to unreasonable risks.
IV. Next Step Is Risk Management
Consistent with TSCA section 6(a), EPA will propose risk management
regulatory actions to the extent necessary so that BBP, DBP, DCHP,
DEHP, and DIBP no longer present an unreasonable risk. EPA expects to
focus its risk management actions on the conditions of use that
significantly contribute to the unreasonable risks. In proposing rules
and selecting among requirements, consistent with TSCA section 6(c)(2),
EPA will consider and factor in, to the extent practicable: (i) the
effects of BBP, DBP, DCHP, DEHP, and DIBP on health and the
environment; (ii) the magnitude of exposure to BBP, DBP, DCHP, DEHP,
and DIBP of human beings and the environment; (iii) the benefits of
BBP, DBP, DCHP, DEHP, and DIBP for various uses; and (iv) the
reasonably ascertainable economic consequences of the rule.
Additional information received may inform the risk management of
the phthalates and, like the prioritization and risk evaluation
processes, there will be an opportunity for public comment on any
proposed risk management actions.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 31, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and
Pollution Prevention.
[FR Doc. 2025-24290 Filed 1-5-26; 8:45 am]
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