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, 14836-14838 [2024-04212]
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14836
Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices
information whose disclosure is
restricted by statute.
Submit written comments and
recommendations to OMB for the
proposed information collection within
30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
30-day Review—Open for Public
Comments’’ or by using the search
function.
FOR FURTHER INFORMATION CONTACT:
Aaron Letterly, Office of Transportation
and Air Quality, Environmental
Protection Agency, 2000 Traverwood
Drive, Ann Arbor, MI 48105; telephone
number 734–214–4340, email address:
letterly.aaron@epa.gov.
SUPPLEMENTARY INFORMATION: This is a
proposed extension of the ICR, which is
currently approved through February
29, 2024. An agency may not conduct or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
Public comments were previously
requested via the Federal Register on
August 8, 2023 during a 60-day
comment period (88 FR 53483). This
notice allows for an additional 30 days
for public comments. Supporting
documents which explain in detail the
information that the EPA will be
collecting are available in the public
docket for this ICR. The docket can be
viewed online at www.regulations.gov
or in person at the EPA Docket Center,
WJC West, Room 3334, 1301
Constitution Ave. NW, Washington, DC.
The telephone number for the Docket
Center is 202–566–1744. For additional
information about EPA’s public docket,
visit https://www.epa.gov/dockets.
Abstract: Transportation conformity is
required under Clean Air Act section
176(c) (42 U.S.C. 7506(c)) to ensure that
federally supported transportation
activities are consistent with (‘‘conform
to’’) the purpose of the State Air Quality
Implementation Plan (SIP).
Transportation activities include
transportation plans, transportation
improvement programs (TIPs), and
federally funded or approved highway
or transit projects. Conformity to the
purpose of the SIP means that
transportation activities will not cause
or contribute to new air quality
violations, worsen existing violations, or
delay timely attainment of the relevant
National Ambient Air Quality Standards
(NAAQS)) or interim milestones.
Transportation conformity applies
under EPA’s conformity regulations at
40 CFR part 93, subpart A, to areas that
are designated nonattainment and
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maintenance areas for the following
transportation-related criteria
pollutants: ozone, particulate matter
(PM2.5 and PM10), carbon monoxide
(CO), and nitrogen dioxide (NO2). EPA
published the original transportation
conformity rule on November 24, 1993
(58 FR 62188), and has subsequently
published several revisions. EPA
develops the conformity regulations in
coordination with the Federal Highway
Administration (FHWA) and Federal
Transit Administration (FTA). The
federal government needs information
collected under these regulations to
ensure that metropolitan planning
organization (MPO) and federal
transportation actions are consistent
with state air quality goals.
Form numbers: None.
Respondents/affected entities: MPOs,
local transit agencies, state departments
of transportation, and state and local air
quality agencies.
Respondent’s obligation to respond:
Mandatory pursuant to Clean Air Act
section 176(c) (42 U.S.C. 7506(c)) and 40
CFR part 93.
Estimated number of respondents:
145 (total).
Frequency of response: Typically,
once every four years for transportation
plans and TIPs, and for the largest
MPOs with three or more NAAQS, once
every three years for transportation
plans and TIPs. As needed for projects.
Total estimated burden: 42,481 hours
(per year). Burden is defined at 5 CFR
1320.03(b).
Total estimated cost: $2,946,914 (per
year), which includes $0 annualized
capital or operation & maintenance
costs.
Changes in the estimates: There is a
decrease of 6,190 hours in the total
estimated respondent burden compared
with the ICR currently approved by
OMB. This decrease in burden was
projected due to the requirement for
transportation conformity ending in
PM10, NO2, and CO maintenance areas
that have reached the end of the 20-year
maintenance period.
Courtney Kerwin,
Director, Information Engagement Division.
[FR Doc. 2024–04153 Filed 2–28–24; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2024–0073; FRL–11760–
01–OCSPP]
Di-isodecyl Phthalate (DIDP) and Diisononyl Phthalate (DINP); Draft Risk
Evaluations; Science Advisory
Committee on Chemicals (SACC) Peer
Review; Request for Nominations of ad
hoc Expert Reviewers
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 SACC@epa.gov.
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: kamel.alaa@
epa.gov.
SUMMARY:
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
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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.
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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, nongovernmental 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
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other SACC-related activities: https://
public.govdelivery.com/accounts/
USAEPAOPPT/subscriber/new?topic_
id=USAEPAOPPT_101.
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 https://www.epa.gov/assessingand-managing-chemicals-under-tsca/
how-epa-evaluates-safety-existingchemicals.
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
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14837
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: 1,2benzenedicarboxylic acid, 1,2diisodecyl ester (CASRN 26761–40–0)
and 1,2-benzenedicarboxylic acid, diC9-11-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: 1,2benzenedicarboxylic acid, 1,2-isononyl
ester (CASRN 28553–12–0) and 1,2benzenedicarboxylic acid, di-C9-11branched 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 noncancer 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
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Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices
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
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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
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16:39 Feb 28, 2024
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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
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Sfmt 4703
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 https://
www.regulations.gov (docket ID No.
EPA–HQ–OPPT–2024–0073) and
through the SACC website at https://
www.epa.gov/tsca-peer-review.
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]
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]]>Agencies
[Federal Register Volume 89, Number 41 (Thursday, February 29, 2024)]
[Notices]
[Pages 14836-14838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04212]
-----------------------------------------------------------------------
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 [email protected].
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:
[email protected].
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: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.
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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals.
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 https://www.regulations.gov (docket ID No.
EPA-HQ-OPPT-2024-0073) and through the SACC website at https://www.epa.gov/tsca-peer-review.
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]
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