Notice2024-10999
Di-isodecyl Phthalate (DIDP) and Di-isononyl Phthalate (DINP); Science Advisory Committee on Chemicals (SACC) Peer Review of Draft Documents; Notice of SACC Meeting; Availability; and Request for Comment
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Published
May 20, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or "Agency") is announcing the availability of and soliciting public comment on the draft manufacturer-requested risk evaluation for Di-isodecyl Phthalate (DIDP) and the draft physical chemical, fate, and hazard assessments for Di-isononyl Phthalate (DINP) prepared under the Toxic Substances Control Act (TSCA). The draft documents will also be submitted to the Science Advisory Committee on Chemicals (SACC) for peer review. EPA is also announcing that there will be two virtual public meetings of the SACC: On July 23, 2024, for the SACC to consider the scope and clarity of the draft charge questions for the peer review; and on July 30- August 2, 2024, for the SACC to consider the draft documents and public comments for peer review.
Full Text
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<title>Federal Register, Volume 89 Issue 98 (Monday, May 20, 2024)</title>
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[Federal Register Volume 89, Number 98 (Monday, May 20, 2024)]
[Notices]
[Pages 43847-43850]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10999]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0073; FRL-11760-02-OCSPP]
Di-isodecyl Phthalate (DIDP) and Di-isononyl Phthalate (DINP);
Science Advisory Committee on Chemicals (SACC) Peer Review of Draft
Documents; Notice of SACC Meeting; Availability; and Request for
Comment
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is
announcing the availability of and soliciting public comment on the
draft manufacturer-requested risk evaluation for Di-isodecyl Phthalate
(DIDP) and the draft physical chemical, fate, and hazard assessments
for Di-isononyl Phthalate (DINP) prepared under the Toxic Substances
Control Act (TSCA). The draft documents will also be submitted to the
Science Advisory Committee on Chemicals (SACC) for peer review. EPA is
also announcing that there will be two virtual public meetings of the
SACC: On July 23, 2024, for the SACC to consider the scope and clarity
of the draft charge questions for the peer review; and on July 30-
August 2, 2024, for the SACC to consider the draft documents and public
comments for peer review.
DATES:
Virtual Preparatory Public Meeting
Comments: Submit written comments on the scope and clarity of the
charge questions on or before noon (12:00 p.m. EDT) on July 19, 2024.
Registration: To request time to present oral comments, you must
register by noon (12:00 p.m. EDT) on July 19, 2024. For those not
making oral comments, registration will remain open through the end of
the meeting on July 19, 2024.
Meeting date: July 23, 2024, 1 p.m. to 4 p.m. (EDT).
Virtual Peer Review Public Meeting
Comments: Submit comments on or before July 19, 2024.
Registration: To request time to present oral comments, you must
register by noon, July 26, 2024. For those not making oral comments,
registration will remain open through the end of the meeting.
Meeting dates: July 30-August 2, 2024, 10 a.m. to 5 p.m. (EDT).
Special Accommodations
To allow sufficient time for EPA to process your request before the
applicable meeting, please submit your requests at least ten business
days in advance of the meeting.
See unit III. of SUPPLEMENTARY INFORMATION.
ADDRESSES:
Comments: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0073, through the Federal eRulemaking
Portal 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 is available at
<a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
Meeting registration: For information and instructions on how to
register and access these virtual public meetings, please refer to the
SACC website at <a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a>. After
registering, you will receive the webcast and streaming service meeting
links and audio teleconference information.
Special accommodation requests: To request accommodation for a
disability, please contact the Designated Federal Official (DFO) listed
under FOR FURTHER INFORMATION CONTACT.
[[Page 43848]]
FOR FURTHER INFORMATION CONTACT:
SACC peer review: The Designated Federal Official (DFO) is Dr. Alaa
Kamel, Mission Support Division (7602M), Office of Program Support,
Office of Chemical Safety and Pollution Prevention, Environmental
Protection Agency; telephone number: (202) 564-5336 or SACC main office
number: (202) 564-8450; email address: <a href="/cdn-cgi/l/email-protection#f79c969a929bd9969b9696b7928796d9909881"><span class="__cf_email__" data-cfemail="0b606a666e67256a676a6a4b6e7b6a256c647d">[email protected]</span></a>.
Draft documents: Todd Coleman, Existing Chemicals Risk Management
Division (7404M), Office of Pollution Prevention and Toxics, Office of
Chemical Safety and Pollution Prevention, Environmental Protection
Agency; telephone number: (202) 564-1208; email address:
<a href="/cdn-cgi/l/email-protection#3b5854575e565a55154f545f5f7b5e4b5a155c544d"><span class="__cf_email__" data-cfemail="5734383b323a363979233833331732273679303821">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
EPA is announcing the availability of and soliciting public comment
on the draft risk evaluation for DIDP and the draft physical chemical,
fate, and hazard assessments for DINP. EPA is also announcing a virtual
peer review public meeting on July 30-August 2, 2024, for the SACC to
consider and review the draft documents. A virtual preparatory public
meeting will be held on July 23, 2024, for the SACC to consider and ask
questions regarding the scope and clarity of the draft charge
questions. This document provides instructions for accessing the
materials, submitting written comments, and registering to provide oral
comments and attend the public meetings.
B. What is the Agency's authority for taking this action?
EPA established the SACC in 2016 in accordance with the 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 (FACA), 5 U.S.C. 10, and supports
activities under TSCA, 15 U.S.C. 2601 et seq., the Pollution Prevention
Act (PPA), 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 substance, and/or
those interested in the assessment of risks involving chemical
substances and mixtures regulated under TSCA (including members of at-
risk communities, non-governmental organizations (NGOs), Federal,
State, and local officials). Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be interested.
D. What should I consider as I submit my comments to EPA?
1. Submitting CBI. Do not submit CBI to EPA through email or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you wish to include CBI in your
comment, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT to obtain special instructions before submitting that
information.
2. Tips for preparing your comments. When preparing and submitting
your comments, see <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.C.
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 the 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., synthetic biology, pharmacology, biotechnology,
nanotechnology, biochemistry, biostatistics, physiologically based
pharmacokinetic (PBPK) modeling, computational toxicology,
epidemiology, environmental fate, and environmental engineering and
sustainability). The SACC currently consists of 18 members. When
needed, the 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 prioritized
chemical substances and allows chemical manufacturers to request an
EPA-conducted risk evaluation of a chemical substance (or category of
chemical substances) using the procedures established in 40 CFR 702.37.
TSCA also identifies the minimum components EPA must include in all
chemical substance risk evaluations. EPA received manufacturer requests
to conduct risk evaluations for DIDP and DINP, both as categories of
chemical substances, and subsequently granted and initiated risk
evaluations for both of them. 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 (COUs). These evaluations include assessing
unreasonable 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 is EPA evaluating the risks from DIDP and DINP?
On May 24, 2019, EPA received requests to conduct risk evaluations
for DIDP and DINP from ExxonMobil Chemical Company, Evonik Corporation,
and Teknor Apex, through the American Chemistry Council's High
Phthalates Panel (ACC HPP). In December 2019, EPA notified ACC HPP that
the Agency had granted their manufacturer requested risk evaluations.
DIDP is a common chemical name for the category of chemical
substances that includes the following substances: 1,2-
benzenedicarboxylic acid, 1,2-diisodecyl ester (CASRN 26761-40-0) and
1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
(CASRN 68515-49-1). Both CASRNs contain mainly C10 dialkyl phthalate
esters.
DINP is a common chemical name for the category of chemical
substances that includes the following substances: 1,2-
benzenedicarboxylic acid, 1,2-isononyl ester (CASRN 28553-12-0) and
1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C9-rich
(CASRN 68515-48-0). Both CASRNs contain mainly C9 dialkyl phthalate
esters. Both DIDP and DINP are primarily used as a plasticizer in
polyvinyl chloride (PVC) in consumer, commercial, and industrial
applications.
[[Page 43849]]
DIDP and DINP are both structurally phthalates, and therefore many
aspects of physical-chemical (p-chem) properties and exposure (to
humans and ecological species) are similar, described further in the
draft physical chemical and fate assessments for both chemical
substances. Because of the similar exposure and physical chemical
properties of DIDP and DINP, EPA is developing these individual risk
evaluations in parallel, and similarly the SACC peer review of the
methods and novel analyses for the draft risk evaluations will occur
concurrently. Both DIDP and DINP have extremely low water solubility
and will be preferentially sorbed into sediments, soils, and suspended
solids in surface water and wastewater. Both are expected to be
persistent in anaerobic environments. Under indoor settings, DIDP and
DINP are expected to partition to airborne particles and are expected
to have extended lifetime compared to outdoor settings.
For both DIDP and DINP, liver and developmental toxicity are
indicated as the most sensitive and robust non-cancer hazards. However,
these two phthalates differ in several important respects regarding
their human health hazard profiles. For DIDP, the developmental
toxicity is not characterized by androgen insufficiency, and data are
insufficient to determine the carcinogenicity. For DINP, developmental
toxicity results in androgen insufficiency (phthalate syndrome), and
the effects on the liver include cancer. Therefore, because of these
hazard differences, EPA is requesting peer review on the draft hazard
assessment of DINP ahead of issuing the risk evaluation of DINP.
D. What is the topic of the planned SACC peer review?
EPA is submitting the draft risk evaluation of DIDP, draft physical
chemical, fate, and hazard assessments of DINP, and associated
supporting documents to the SACC for peer review, along with the public
comments received. The draft risk evaluation for DIDP includes analyses
of physical chemical properties, the fate and transport in the
environment, exposure to workers, consumers and general population
including potentially exposed or susceptible subpopulations (PESS),
releases to the environment, environmental hazard and risk
characterization for terrestrial and aquatic species, and human health
hazard and risk characterization for workers, consumers, and the
general population. The draft assessments of DINP includes analyses of
physical chemical properties, the fate and transport in the
environment, environmental hazard for terrestrial and aquatic species,
human health non-cancer hazards, and human health cancer hazards.
EPA is not developing charge questions for all aspects of the draft
documents but is instead focusing its charge to the SACC on specific
scientific areas that need peer review. Many of the methods and
analyses used in these evaluations are not novel and have been reviewed
in the development of the tools, used in various agency work products
or in previous TSCA assessments (e.g., systematic review, consumer
exposure model (CEM), American Meteorological Society (AMS)/EPA
Regulatory Model (AERMOD), point source calculator (PSC), etc.). Also,
EPA is not soliciting comments on uses of these phthalates that are
outside the scope of TSCA (e.g., personal care products, cosmetics,
food contact materials, medical devices); those uses will be addressed
as appropriate within the cumulative risk assessment.
As a result of the similarities in conditions of use, chemical
properties, and data availability between DIDP and DINP, the methods
and approaches used to assess DIDP apply to DINP. Nonetheless, these
two chemicals differ most in their human health hazard profiles and
therefore SACC is requested to review these novel analyses for DINP.
Any relevant recommendations from this SACC review on DIDP will be also
considered in the development of the final risk evaluations for both
DIDP and DINP. By taking the DIDP risk evaluation and DINP hazard
assessments to peer review in this manner, EPA will obtain the
necessary independent review and advice for the DINP risk evaluation.
EPA continues to work on risk evaluations of additional high-
priority substance phthalates, in addition to the cumulative risk
assessment (CRA) for the phthalates. The subsequent five individual
risk evaluations and the CRA are not part of this peer review but will
be brought to the SACC for peer review at a future date.
III. Public Meeting of the SACC
A. What is the purpose of the virtual peer review public meeting(s)?
EPA is planning two virtual public meetings: (1) A preparatory
public meeting for the SACC to consider and ask questions regarding the
scope and clarity of the draft charge questions; and (2) a public
meeting for the SACC to consider and review the draft documents. These
public meetings are part of the SACC peer review of the Agency's
methods and novel analyses for the draft evaluations of the risks from
the phthalates DIDP and DINP to inform risk management decisions under
TSCA. EPA expects to ask the SACC to consider and review this DIDP
draft risk evaluation and DINP assessments. The agenda for these
meetings will be posted in the docket and the SACC website.
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 beginning approximately one month prior to the
meeting, and remain open through the end of the meeting. To make oral
comments during one of these meetings, follow the instructions in unit
III.C.
Recommendations from this SACC review and public comments will be
considered in the development of the final risk evaluation for DIDP and
DINP. The Agency will be seeking SACC 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 access the documents?
The manufacturer-requested draft risk evaluation for DIDP, draft
assessments for DINP, and related documents, including background
documents, related supporting materials, and draft charge questions,
are available in the docket. As additional background materials become
available, EPA will include those additional background materials
(e.g., SACC members and consultants participating in this meeting and
the meeting agenda) in the docket and through links on the SACC website
at <a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a>.
After the public meeting, the SACC will prepare the meeting minutes
and a final report document summarizing its recommendations to the EPA,
which will also be available in the docket and through the SACC
website.
C. How can I provide comments?
To ensure proper receipt of comments, it is imperative that you
identify docket ID No. EPA-HQ-OPPT-2024-0073 in the subject line on the
first page of your comments and follow the instructions in this
document.
1. Written comments. Submit written comments by the deadlines set
in the DATES section of this document and as described in the ADDRESSES
section of this document.
[[Page 43850]]
2. Oral comments. To request time to present oral comments during
one of the virtual public meetings, you must register online by the
deadlines set in the DATES section of this document. Oral comments
during the virtual public meetings are limited to 5 minutes. In
addition, each speaker should submit a written 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.
Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10.
Dated: May 15, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-10999 Filed 5-17-24; 8:45 am]
BILLING CODE 6560-50-P
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