Notice2025-14882
Butyl Benzyl Phthalate (BBP); Diisobutyl Phthalate (DIBP); Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment
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Published
August 6, 2025
Issuing agencies
Environmental Protection Agency
Abstract
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 Butyl Benzyl Phthalate (BBP) (CARSN 85-68-7) and Diisobutyl Phthalate (DIBP) (CASRN 84-69-5). 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 BBP and DIBP pose unreasonable risk to health and the environment driven primarily by certain conditions of use analyzed in the draft risk evaluations.
Full Text
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<title>Federal Register, Volume 90 Issue 149 (Wednesday, August 6, 2025)</title>
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[Federal Register Volume 90, Number 149 (Wednesday, August 6, 2025)]
[Notices]
[Pages 37855-37857]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14882]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0501 and EPA-HQ-OPPT-2018-0434; FRL-12897-01-OCSPP]
Butyl Benzyl Phthalate (BBP); Diisobutyl Phthalate (DIBP); 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
Butyl Benzyl Phthalate (BBP) (CARSN 85-68-7) and Diisobutyl Phthalate
(DIBP) (CASRN 84-69-5). 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 BBP and DIBP pose unreasonable risk to health and the environment
driven primarily by certain conditions of use analyzed in the draft
risk evaluations.
DATES: Comments must be received on or before October 6, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0501 and EPA-HQ-OPPT-2018-0434, online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information on BBP: Brianne Raccor, Existing
Chemicals Risk Management Division (7404M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
[[Page 37856]]
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-0303; email address: <a href="/cdn-cgi/l/email-protection#087a696b6b677a266a7a616966666d486d7869266f677e"><span class="__cf_email__" data-cfemail="11637072727e633f736378707f7f74517461703f767e67">[email protected]</span></a>.
For technical information on DIBP: Robert Landolfi, Existing
Chemicals Risk Management Division (7404M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 343-9161; email address: <a href="/cdn-cgi/l/email-protection#d2beb3bcb6bdbeb4bbfca0bdb0b7a0a692b7a2b3fcb5bda4"><span class="__cf_email__" data-cfemail="187479767c77747e71366a777a7d6a6c587d6879367f776e">[email protected]</span></a>.
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: <a href="/cdn-cgi/l/email-protection#85d1d6c6c4a8cdeaf1e9ecebe0c5e0f5e4abe2eaf3"><span class="__cf_email__" data-cfemail="a6f2f5e5e78beec9d2cacfc8c3e6c3d6c788c1c9d0">[email protected]</span></a>.
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 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 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 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 BBP 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 to
prepare these draft risk evaluations and, based on the weight of
scientific evidence, to preliminarily determine that BBP and DIBP pose
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you wish to include CBI in your
comment, please follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> 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 <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
A. What are BBP 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). 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 and DIBP are manufactured (including imported), processed,
distributed, and disposed as part of industrial, commercial, and
consumer conditions of use. BBP and DIBP are used as a plasticizer in
polyvinyl chloride (PVC), as well as in adhesives, sealants, paints,
coatings, rubbers, non-PVC plastics, and other applications. Between
2016 and 2019, production volume of BBP was reported to be between 1 to
20 million pounds, based on the 2020 TSCA Chemical Data Reporting (CDR)
data. Between 2016 and 2020 the production volumes of DIBP reported to
CDR were between 380,000 and 441,000 pounds.
B. Summary of Activities for the Risk Evaluations of BBP and DIBP
In December 2019, EPA announced its designation of BBP and DIBP as
high priority substances for risk evaluation under TSCA (Ref. 1). In
June 2020, EPA sought public comment on the draft scopes of the BBP and
DIBP 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 for
each chemical at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. The human health hazard
and environmental hazard technical support documents for BBP and DIBP
are being peer reviewed by the Science Advisory Committee on Chemicals
(SACC) in August 2025 and are 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 BBP (Docket ID No. EPA-HQ-OPPT-2018-0501) and DIBP
(Docket ID No. EPA-HQ-OPPT-2018-0434), 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 is not publicly available.
EPA welcomes specific input on each section of the draft risk
evaluation for each chemical, particularly input on the following:
<bullet> whether and how personal protective equipment and
engineering controls are used during the manufacture, processing, and
use of BBP and DIBP for each condition of use;
<bullet> information that could be used to refine upper-bound or
screening level assumptions for BBP and DIBP, particularly for the COUs
that may significantly contribute to unreasonable risk;
<bullet> information on environmental releases of BBP and DIBP,
including media of environmental release (i.e., air, land, water, or
incineration), facility-specific receiving water bodies, and the use of
wastewater treatment;
[[Page 37857]]
<bullet> information on inhalation occupational exposure to BBP and
DIBP under the COUs, including monitoring or personal breathing zone
data and exposure to respirable particles (i.e., data on particle
formation or size);
<bullet> input on the dermal occupational exposure scenarios used
to assess BBP and DIBP, including the use of a flux-limited approach to
estimate dermal absorption and any supporting data to inform
assumptions regarding duration and surface area of exposure;
<bullet> information to inform the assessment of dermal and
inhalation exposures to BBP and DIBP for occupational non users (ONUs);
<bullet> information on the extent to which spray applications of
BBP and DIBP are used in industrial and commercial COUs and the volumes
of BBP and DIBP that may be used;
<bullet> information to inform assumptions of inhalation of dust/
particulate matter in the consumer exposure assessment of BBP;
<bullet> approaches used to estimate chemical migration rate for
ingestion via mouthing in the BBP and DIBP consumer exposure
assessments;
<bullet> selection of human health and environmental hazard
endpoints used in the BBP and DIBP risk characterizations;
<bullet> integration of its cumulative risk assessment approach
within individual risk evaluations, derivation of relative potency
factors (RPFs), and individual BBP and DIBP PODs; and
<bullet> any other information that may inform the assumptions used
for exposure modeling used to assess the COUs for BBP and DIBP.
Two cross-phthalate TSDs were released to the public in May 2025
through the DBP (EPA-HQ-OPPT-2018-0503), DEHP (EPA-HQ-OPPT-2018-0433),
and SACC (EPA-HQ-OPPT-2024-0551) dockets: Draft Cancer Human Health
Hazard Assessment for Di(2-ethylhexyl) Phthalate (DEHP), Dibutyl
Phthalate (DBP), BBP, DIBP, and DCHP and Revised Draft Technical
Support Document for the Cumulative Risk Analysis of DEHP, DBP, BBP,
DIBP, DCHP, and DINP Under the Toxic Substances Control Act. These TSDs
have been added to the dockets for BBP (EPA-HQ-OPPT-2018-0501), DIBP
(EPA-HQ-OPPT-2018-0434), and DCHP (EPA-HQ-OPPT-2018-0504).
IV. Next Steps
After consideration of comments received from the public and the
SACC on the draft risk evaluations of BBP, DIBP, revised draft
cumulative risk analysis, and other phthalates included in the peer
review, EPA will issue final risk evaluations for BBP and DIBP.
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 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 in its final risk evaluation 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 would be required to implement,
via regulation, regulatory restrictions on the manufacture (including
import), processing, distribution, use or disposal of the chemical to
the extent necessary to eliminate the identified unreasonable risk.
TSCA section 6 includes a range of risk management options that can be
applied alone or in combination, including labeling, recordkeeping or
notice requirements, actions to reduce human exposure or environmental
release, or prohibition of the chemical or of certain uses. Like the
prioritization and risk evaluation processes, there would be 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 <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca</a>.
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: August 2, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and
Pollution Prevention.
[FR Doc. 2025-14882 Filed 8-5-25; 8:45 am]
BILLING CODE 6560-50-P
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