Notice2024-04212
Di-isodecyl Phthalate (DIDP) and Di-isononyl Phthalate (DINP); Draft Risk Evaluations; Science Advisory Committee on Chemicals (SACC) Peer Review; Request for Nominations of ad hoc Expert Reviewers
Primary source
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Published
February 29, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the Agency's evaluation of the risks from di-isodecyl phthalate (DIDP) and di- isononyl phthalate (DINP) being conducted to inform risk management decisions under the Toxic Substances Control Act (TSCA). To facilitate nominations, this document provides information about the SACC, the intended topic for the planned peer review, the expertise sought for this peer review, instructions for submitting nominations to EPA, and the Agency's plan for selecting the ad hoc reviewers for this peer review. EPA is planning to convene a virtual public meeting of the SACC in the summer of 2024 to review the draft risk evaluations.
Full Text
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<title>Federal Register, Volume 89 Issue 41 (Thursday, February 29, 2024)</title>
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[Federal Register Volume 89, Number 41 (Thursday, February 29, 2024)]
[Notices]
[Pages 14836-14838]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04212]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0073; FRL-11760-01-OCSPP]
Di-isodecyl Phthalate (DIDP) and Di-isononyl Phthalate (DINP);
Draft Risk Evaluations; Science Advisory Committee on Chemicals (SACC)
Peer Review; Request for Nominations of ad hoc Expert Reviewers
SUMMARY: The Environmental Protection Agency (EPA) is seeking public
nominations of scientific and technical experts that EPA can consider
for service as ad hoc reviewers assisting the Science Advisory
Committee on Chemicals (SACC) with the peer review of the Agency's
evaluation of the risks from di-isodecyl phthalate (DIDP) and di-
isononyl phthalate (DINP) being conducted to inform risk management
decisions under the Toxic Substances Control Act (TSCA). To facilitate
nominations, this document provides information about the SACC, the
intended topic for the planned peer review, the expertise sought for
this peer review, instructions for submitting nominations to EPA, and
the Agency's plan for selecting the ad hoc reviewers for this peer
review. EPA is planning to convene a virtual public meeting of the SACC
in the summer of 2024 to review the draft risk evaluations.
DATES: Submit your nominations on or before April 1, 2024.
ADDRESSES: Submit your nominations to the SACC at <a href="/cdn-cgi/l/email-protection#0152404242416471602f666e77"><span class="__cf_email__" data-cfemail="3d6e7c7e7e7d584d5c135a524b">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: The Designated Federal Official (DFO)
for the SACC 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 call the SACC main office at (202) 564-8450; email address:
<a href="/cdn-cgi/l/email-protection#1279737f777e3c737e7373527762733c757d64"><span class="__cf_email__" data-cfemail="640f050901084a05080505240114054a030b12">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. What action is the Agency taking?
The Agency is seeking public nominations of scientific and
technical experts that EPA can consider for service as ad hoc reviewers
assisting the SACC with the peer review of the Agency's evaluation of
the risks from DIDP and DINP being conducted to inform risk management
decisions under TSCA. EPA is planning a virtual public meeting to be
held in the summer of 2024 for the SACC to consider and review the
draft risk evaluations. At that
[[Page 14837]]
time, EPA will be soliciting comments from the SACC on the novel
approaches used, the unique exposure analyses and other calculations,
and selection of key hazard endpoints.
To facilitate nominations, this document provides information about
the SACC, the intended topic for the planned peer review, the expertise
sought for this peer review, instructions for submitting nominations to
EPA, and the Agency's plan for selecting the ad hoc reviewers for this
peer review.
B. What is the Agency's authority for taking this action?
The SACC was established by EPA in 2016 in accordance with TSCA
section 26(o), 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. This action may,
however, be of particular interest to those involved in the
manufacture, processing, distribution, and disposal of chemical
substances and mixtures, and/or those interested in the assessment of
risks involving chemical substances and mixtures regulated under TSCA.
Members of at-risk communities, non-governmental organizations (NGOs)
(particularly those with an interest in protecting health for at-risk
communities), and Federal, State and local officials may also be
interested. Since other entities may also be interested, the Agency has
not attempted to describe all the specific entities to which this
action may apply.
D. What should I consider as I submit my nominations to EPA?
Do not submit confidential business information (CBI) or other
sensitive information to EPA through email. If your nomination contains
any information 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.
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 comprised 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, 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 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 (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.
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. 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 draft risk evaluations will occur
concurrently. Both 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. Therefore, ecological risk will be assessed
primarily considering exposure via sediment and soil pathways. 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
[[Page 14838]]
syndrome), and the effects on the liver include cancer.
D. What is the topic of the planned SACC peer review?
EPA is planning this SACC peer review of the Agency's risk
evaluations for DIDP and DINP. EPA expects to ask the SACC to consider
and review the novel approaches, unique exposure analyses and other
calculations, and selection of key hazard endpoints for the risk
evaluations of DIDP and DINP. Feedback from this review will be
considered in the development of the final risk evaluations of the two
phthalates under TSCA.
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 at a future date.
EPA intends to publish a separate document in the Federal Register
to announce the availability of and solicit public comment on the draft
risk evaluations that are submitted to the SACC for peer review, at
which time EPA will provide instructions for submitting written
comments and registering to provide oral comments at the peer review
meeting planned for the summer of 2024.
III. Nominations for ad hoc Reviewers
A. Why is EPA seeking nominations for ad hoc reviewers?
As part of a broader process for developing a pool of candidates
for SACC peer reviews, EPA is asking the public and stakeholders for
nominations of scientific and technical experts that EPA can consider
as prospective candidates for service as ad hoc reviewers assisting the
SACC with the peer reviews. Any interested person or organization may
nominate qualified individuals for consideration as prospective
candidates for this review by following the instructions provided in
this document. Individuals may also self-nominate.
Those who are selected from the pool of prospective candidates will
be invited to attend the public meeting and to participate in the
discussion of key issues and assumptions at the meeting. In addition,
they will be asked to review and to help finalize the meeting minutes.
B. What expertise is sought for this peer review?
Individuals nominated for this SACC peer review should have
expertise in one or more of the following areas: Risk assessment;
ecological risk assessment, including terrestrial hazard/wildlife
toxicology for feedback on Toxicity Reference Value (TRV) approach,
bioaccumulation and fate/physical chemistry (p-chem) for trophic
transfer, and analogue selection; General exposure, particularly,
consumer products and indoor air; Ingestion exposure for mouthing/
ingestion route and chemical migration to saliva, surface water
concentrations, water solubility, and acute aquatic hazard (fate/P-chem
and aquatic toxicology), and use of European Union (EU) percentages to
assign production volumes for the Conditions of Use (engineering);
Human health, including liver toxicity and developmental toxicology for
DIDP (toxicology), cancer and peroxisome proliferator-activated
receptor alpha (PPARa mode of action), and dose response assessment.
Nominees should be scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments on the scientific issues for this review.
C. How do I make a nomination?
Submit your nomination as directed under ADDRESSES by the deadline
indicated under DATES. Each nomination should include the following
information: Contact information for the person making the nomination;
Name, affiliation, and contact information for the nominee; and, The
disciplinary and specific areas of expertise of the nominee.
D. Will ad hoc reviewers be subjected to an ethics review?
SACC members and ad hoc reviewers are subject to the provisions of
the Standards of Ethical Conduct for Employees of the Executive Branch
at 5 CFR part 2635, conflict of interest statutes in Title 18 of the
United States Code and related regulations. In anticipation of this
requirement, prospective candidates for service on the SACC will be
asked to submit confidential financial information which shall fully
disclose, among other financial interests, the candidate's employment,
stocks, and bonds, and where applicable, sources of research support.
EPA will evaluate the candidates' financial disclosure forms to assess
whether there are financial conflicts of interest, appearance of a loss
of impartiality, or any prior involvement with the development of the
documents under consideration (including previous scientific peer
review) before the candidate is considered further for service on the
SACC.
E. How will EPA select the ad hoc reviewers?
The selection of scientists to serve as ad hoc reviewers for the
SACC is based on the function of the Committee and the expertise needed
to address the Agency's charge to the Committee. No interested
scientists shall be ineligible to serve by reason of their membership
on any other advisory committee to a federal department or agency or
their employment by a federal department or agency, except EPA. Other
factors considered during the selection process include availability of
the prospective candidate to fully participate in the Committee's
reviews, ability to be hired as an EPA Special Government Employee
(SGE), absence of any conflicts of interest or appearance of loss of
impartiality, independence with respect to the matters under review,
and lack of bias. Although financial conflicts of interest, the
appearance of loss of impartiality, lack of independence, and bias may
result in non-selection, the absence of such concerns does not assure
that a candidate will be selected to serve on the SACC.
Numerous qualified candidates are often identified for SACC
reviews. Therefore, selection decisions involve carefully weighing
several factors including the candidates' areas of expertise and
professional qualifications and achieving an overall balance of
different scientific perspectives across reviewers. The Agency will
consider all nominations of prospective candidates for service as ad
hoc reviewers for the SACC that are received by the deadline listed
under DATES. However, the final selection of ad hoc reviewers is a
discretionary function of the Agency.
EPA anticipates selecting 8-10 ad hoc reviewers to assist the SACC
in their review of the designated topic. EPA plans to make a list of
candidates under consideration as prospective ad hoc reviewers for this
review available for public comment in April 2024. The list will be
available in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a> (docket ID No.
EPA-HQ-OPPT-2024-0073) and through the SACC website at <a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a>.
Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10.
Dated: February 23, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-04212 Filed 2-28-24; 8:45 am]
BILLING CODE P
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