Notice2026-07172
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-Hexamethylcyclopenta [g]-2-Benzopyran (HHCB); Phthalic Anhydride; o-Dichlorobenzene (o-DCB) and p-Dichlorobenzene (p-DCB); Science Advisory Committee on Chemicals (SACC) Peer Review; Draft Risk Evaluations; Notice of SACC Meeting; Availability of Draft Documents and Request for Comment
Primary source
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Published
April 14, 2026
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is announcing that there will be two virtual public meetings of the Science Advisory Committee on Chemicals (SACC). On May 26, 2026, a preparatory meeting will be held for the SACC to consider the scope and clarity of the draft charge questions for the peer review of the draft risk evaluations for 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8- hexamethylcyclopenta [g ]-2-benzopyran (HHCB) and phthalic anhydride and the draft hazard assessments for o-dichlorobenzene (o-DCB) and p- dichlorobenzene (p-DCB). The peer review meeting will be held June 8 through 12, 2026, for the SACC to consider the draft risk evaluations for HHCB and phthalic anhydride, the draft hazard assessments for o-DCB and p-DCB, the technical support documents, and their public comments. EPA is also announcing the availability of and soliciting public comment on the draft documents and charge questions that will be provided to the SACC for this peer review. The draft risk evaluations and draft hazard assessments were prepared under the Toxic Substances Control Act (TSCA) and will be submitted to the SACC for peer review.
Full Text
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<title>Federal Register, Volume 91 Issue 71 (Tuesday, April 14, 2026)</title>
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[Federal Register Volume 91, Number 71 (Tuesday, April 14, 2026)]
[Notices]
[Pages 19131-19133]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07172]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2026-1189; FRL-13266-01-OCSPP]
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-Hexamethylcyclopenta [g]-2-
Benzopyran (HHCB); Phthalic Anhydride; o-Dichlorobenzene (o-DCB) and p-
Dichlorobenzene (p-DCB); Science Advisory Committee on Chemicals (SACC)
Peer Review; Draft Risk Evaluations; Notice of SACC Meeting;
Availability of Draft Documents 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 that there will be two virtual public meetings of the
Science Advisory Committee on Chemicals (SACC). On May 26, 2026, a
preparatory meeting will be held for the SACC to consider the scope and
clarity of the draft charge questions for the peer review of the draft
risk evaluations for 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-
hexamethylcyclopenta [g ]-2-benzopyran (HHCB) and phthalic anhydride
and the draft hazard assessments for o-dichlorobenzene (o-DCB) and p-
dichlorobenzene (p-DCB). The peer review meeting will be held June 8
through 12, 2026, for the SACC to consider the draft risk evaluations
for HHCB and phthalic anhydride, the draft hazard assessments for o-DCB
and p-DCB, the technical support documents, and their public comments.
EPA is also announcing the availability of and soliciting public
comment on the draft documents and charge questions that will be
provided to the SACC for this peer review. The draft risk evaluations
and draft hazard assessments were prepared under the Toxic Substances
Control Act (TSCA) and will be submitted to the SACC for peer review.
DATES:
Preparatory Public Meeting
Meeting date: May 26, 2026, 1 p.m. to approximately 4 p.m. (ET).
Registration: To request time to present oral comments during the
preparatory meeting, you must register by noon (12 p.m. ET) on May 18,
2026, and submit a written version of your oral comments by noon (12
p.m. ET) on May 22, 2026. For those not making oral comments,
registration will remain open until the end of this meeting on May 26,
2026.
SACC Peer Review Public Meeting
Meeting dates: June 8 through 12, 2026, 10 a.m. to approximately 5
p.m. (ET).
Registration: To request time to present oral comments during the
SACC peer review meeting, you must register by noon (12 p.m. ET) June
1, 2026, and submit a written version of your oral comments by noon (12
p.m. ET) on June 5, 2026. For those not making oral comments,
registration will remain open through the end of this meeting on June
12, 2026.
Comments: To ensure proper receipt of comments, it is imperative
that you identify docket identification (ID): EPA-HQ-OPPT-2025-1610 in
the subject line on the first page of your comments and follow the
instructions in this document.
Submit written comments on the draft risk evaluations, draft hazard
assessments, and technical support documents for consideration by the
SACC for peer review on or before May 29, 2026.
To request time to present oral comments during one of the virtual
public meetings, you must register online by the deadlines set in this
section of the document. Oral comments during the peer review meeting
are limited to five minutes unless arrangements have been made with the
Designated Federal Official (DFO), within the constraints of the
meeting agenda. In addition, each speaker should submit a written
transcript or copy of their oral comments and any supporting materials
(e.g., presentation slides) to the DFO prior to the meetings for
distribution to the SACC by the deadlines set in this section of the
document.
Special Accommodations: To allow sufficient time for EPA to process
your request for special accommodation before both the preparatory and
SACC peer review meetings, please submit the request at least ten
business days in advance of the relevant meeting.
ADDRESSES:
Comments: Submit written comments, identified by docket ID: EPA-HQ-
OPPT-2026-1189, through <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online
instructions for submitting comments. Do not electronically submit any
information you consider to be
[[Page 19132]]
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Members of the public should also
be aware that personal information included in any written comments may
be posted on the internet at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional
information on commenting or 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>.
Meeting(s) registration: Online registration for both the
preparatory and the SACC peer review meetings will be available in
April 2026. Please refer to the SACC website at <a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a> to complete and submit the registration form(s)
approximately one month prior to each meeting. After registering, you
will receive the webcast and streaming service meeting links and audio
teleconference information.
Special accommodation requests: To request an accommodation for a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT.
FOR FURTHER INFORMATION CONTACT:
DFO: Dr. Alaa Kamel, Science Advisory Committee Branch, mail code
7602M, Regulatory and Information Services Division, Office of Mission
Critical Operations, Office of Chemical Safety and Pollution
Prevention, Environmental Protection Agency; telephone number: (202)
564-5336 or call the SACC main office: (202) 564-8450; email address:
<a href="/cdn-cgi/l/email-protection#e68d878b838ac8878a8787a6839687c8818990"><span class="__cf_email__" data-cfemail="7e151f131b12501f121f1f3e1b0e1f50191108">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
EPA is announcing that there will be two virtual public meetings of
the SACC. On May 26, 2026, there will be a preparatory meeting for the
SACC to consider the scope and clarity of the draft charge questions
for the peer review; and on June 8 through 12, 2026, there will be a
peer review meeting for the SACC to consider the draft risk evaluations
for HHCB and phthalic anhydride, the draft hazard assessments for o-DCB
and p-DCB, the technical support documents, and their public comments.
EPA is also announcing the availability of and soliciting public
comments on the draft documents and charge questions that will be
provided to the SACC for this peer review.
B. What is the Agency's authority for taking this action?
EPA established the SACC in 2016 in accordance with TSCA, 15 U.S.C.
2625(o), to provide independent advice and expert consultation with
respect to the scientific and technical aspects of issues relating to
the implementation of TSCA. The SACC operates in accordance with the
Federal Advisory Committee Act, 5 U.S.C. 10, and supports activities
under TSCA, 15 U.S.C. 2601 et seq., the Pollution Prevention Act, 42
U.S.C. 13101 et seq., and other applicable statutes.
C. 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, and disposal of the subject chemical substances, and/or
those interested (including members of at-risk communities; non-
governmental organizations; and federal, state, and local officials) in
the assessment of risks involving chemical substances and mixtures
regulated under TSCA.
D. What should I consider as I submit my comments to EPA?
1. Submitting CBI. Do not submit CBI or other sensitive information
to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. To include
information in your comment that you consider to be CBI or otherwise
protected, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT to obtain special instructions before submitting that
information.
2. Tips for preparing 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>. See also the instructions in Unit III of this
document.
E. How can I stay informed about SACC activities?
You may subscribe to the following listserv for alerts regarding
this and other SACC-related activities: <a href="https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101">https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101</a>.
II. Background
A. What is the purpose of SACC?
The SACC provides independent advice and recommendations to the EPA
on the scientific and technical aspects of risk assessments,
methodologies, and pollution prevention measures and approaches for
chemicals regulated under TSCA. The SACC is composed of experts in
toxicology, environmental risk assessment, exposure assessment, and
related sciences (e.g., chemistry, biology, toxicology, pharmacology,
biotechnology, nanotechnology, biochemistry, biostatistics,
physiologically based pharmacokinetic modeling, computational
toxicology, epidemiology, environmental fate, and environmental
engineering and sustainability). When needed, the SACC committee will
be assisted by ad hoc reviewers with specific expertise in the topics
under consideration.
B. Why is EPA conducting these risk evaluations?
TSCA requires EPA to conduct risk evaluations on high-priority
chemical substances and identifies the minimum components EPA must
include in all chemical substance risk evaluations. The purpose of
conducting risk evaluations is to determine whether a chemical
substance presents an unreasonable risk to human health or the
environment under the conditions of use. These evaluations include
assessing risks to relevant potentially exposed or susceptible
subpopulations. As part of this process, EPA: (1) Integrates hazard and
exposure assessments using the best available science that is
reasonably available to assure decisions are based on the weight of the
scientific evidence and (2) Conducts peer review for risk evaluation
approaches that have not been previously peer reviewed. For more
information about the three stages of EPA's process for ensuring the
safety of existing chemicals (i.e., prioritization, risk evaluation,
and risk management), go to <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals</a>.
C. Why did EPA develop these documents?
HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-
hexamethylcyclopenta[[gamma]]-2-benzopyran (CASRN 1222-05-5)), commonly
known by the trade name Galaxolide, phthalic anhydride (CASRN 85-44-9),
o-DCB (ortho- or 1,2-dichlorobenzene (CASRN 95-50-1)) and p-DCB (para-
or 1,4-dichlorobenzene (CASRN 106-46-7)), were designated in December
2019 as high-priority substances under the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, and are currently in the risk
evaluation process. EPA published draft and final scopes in April and
August 2020, respectively. The scope documents outlined the hazards,
exposures, conditions of use, and the potentially exposed or
susceptible subpopulations the Agency expected to consider in its risk
evaluations.
On January 22, 2026, EPA leadership re-committed the Agency to
phasing out mammalian animal testing and further incorporating New
Approach Methods (NAMs) approaches into chemical risk
[[Page 19133]]
evaluations. These NAMs approaches have been incorporated into
forthcoming risk evaluations.
D. What is the topic of the planned SACC peer review?
EPA is soliciting comments from the SACC on a variety of charge
questions related to HHCB, phthalic anhydride, o-DCB, and p-DCB. Many
of the methods and analyses used in these risk evaluations and hazard
assessments are not novel and have been reviewed in the development of
the tools used in various Agency work products or in previous TSCA
assessments. EPA is focusing peer review on critical inputs and novel
approaches.
EPA anticipates requesting the SACC to provide feedback on the
following documents:
<bullet> Complete draft risk evaluation for HHCB, including risk
characterization and associated technical support documents related to
hazard and exposure assessment.
<bullet> Complete draft risk evaluation for phthalic anhydride,
including risk characterization and associated technical support
documents related to hazard and exposure assessment.
<bullet> Draft hazard assessments and technical support documents
for human health and ecological hazard for o-DCB and p-DCB.
In addition, EPA expects to solicit feedback on the following
scientific issues, which have been incorporated into forthcoming risk
evaluations in alignment with the Agency's recent announcement on
phasing out mammalian animal testing.
1. Use of 5-Day Transcriptomic Studies
<bullet> Interpretation and application of transcriptomic studies
for o-DCB and p-DCB.
<bullet> Application of a transcriptomics study and benchmark dose
modeling of gene expression in rodent tissues to identify a
transcriptomic point-of-departure for o-DCB.
2. Advances in Cancer Risk Assessment
<bullet> Constitutive Androstane Receptor mode of action/adverse
outcome pathway analysis and non-human relevance determination for p-
DCB.
<bullet> Application of the Rethinking Carcinogenicity Assessment
for Agrochemicals Project weight of evidence framework for HHCB and o-
DCB.
3. Application of In Vitro and Computational NAMs
<bullet> Use of skin sensitization and respiratory sensitization in
vitro studies and adverse outcome pathways to support hazard
characterization of phthalic anhydride.
<bullet> Use of skin irritation and dermal absorption in vitro
studies to support hazard identification of HHCB.
<bullet> Computational approaches, including use of the Skin
Allergy Risk Assessment-Integrated Chemical Environment model for
phthalic anhydride.
<bullet> Computational approaches for o-DCB.
4. Additional Non-Cancer Human Health Hazard Issues
<bullet> Use and interpretation of the Extended One-Generation
Reproductive Toxicity Study for HHCB.
5. Screening Level Approaches for Occupational and Consumer Exposure
Assessment
<bullet> The data and methods utilized in the screening-level
occupational and consumer exposure assessments for HHCB, including
evidence regarding bioconcentration and bioaccumulation and associated
human exposure through fish consumption.
<bullet> The use of the thin film model for dermal exposure and the
applicability to the chosen exposure scenarios.
6. Environmental Hazard Technical Support Documentation
<bullet> The data and methods used to characterize environmental
hazards of HHCB and phthalic anhydride.
III. Virtual Public Meetings of the SACC
A. What is the purpose of the virtual public meeting(s)?
The purpose of the preparatory meeting is for the SACC to consider
and ask questions regarding the scope and clarity of the draft charge
questions. The purpose of the peer review meeting is for the SACC to
consider and peer review the draft risk evaluations, draft hazard
assessments, and technical support documents. These public meetings are
part of the SACC's peer review of the Agency's methods and novel
analyses for the draft risk evaluations and draft hazard assessments.
The agenda for these meetings will be posted in the docket and will
also be available through the SACC website.
EPA will consider recommendations from this SACC review and public
comments in the development of the final TSCA risk evaluations, which
may inform other EPA efforts related to the assessment and regulation
of the chemical substances. The Agency is seeking peer review of its
data analyses and methodologies relevant to human health hazard and
exposure analyses that have not been previously peer reviewed.
B. How can I participate in the virtual public meeting(s)?
To participate in these virtual public meetings, you must register
online to receive the webcast and streaming service meeting links and
audio teleconference information for each meeting. Online registration
will be available approximately one month prior to the meeting(s) and
will remain open until the end of the meeting. To make oral comments
during one of these meetings, follow the instructions in this document.
C. How can I access the documents?
The draft risk evaluations, draft hazard assessments, related
technical supporting materials, and draft charge questions are
available in docket ID number EPA-HQ-OPPT-2026-1189 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. EPA will include additional meeting background
materials as they become available, (e.g., SACC members and the meeting
agenda) in the docket and through the Peer Review of the Draft Risk
Evaluations for HHCB and phthalic anhydride and the draft hazard
assessments for o-DCB and p-DCB website at <a href="https://www.epa.gov/tsca-peer-review/peer-review-evaluating-hhcb-phthalic-anhydride-o-dcb-and-p-dcb">https://www.epa.gov/tsca-peer-review/peer-review-evaluating-hhcb-phthalic-anhydride-o-dcb-and-p-dcb</a>.
IV. Next Steps
After the peer review meeting, the SACC will prepare the meeting
minutes and final report document summarizing its recommendations to
the EPA, which will also be available in the docket and through the
SACC website. EPA will consider the SACC recommendations and public
comments to complete the risk evaluations and unreasonable risk
determinations under TSCA for these chemical substances. Under TSCA,
EPA must then initiate risk management actions to address the
unreasonable risk if identified.
(Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10.)
Dated: April 10, 2026.
Douglas M. Troutman,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2026-07172 Filed 4-13-26; 8:45 am]
BILLING CODE 6560-50-P
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