Tris(2-chloroethyl) Phosphate (TCEP); Draft Risk Evaluation under the Toxic Substances Control Act (TSCA); Letter Peer Review; Request for Nominations of Expert Reviewers, 67278-67280 [2023-21544]
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lotter on DSK11XQN23PROD with NOTICES1
67278
Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices
NEW) to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act. Before doing so, EPA is
soliciting public comments on specific
aspects of the proposed information
collection as described below. This is a
request for approval of a new collection.
This notice allows for 60 days for public
comments.
DATES: Comments must be submitted on
or before November 28, 2023.
ADDRESSES: Submit your comments,
referencing Docket ID Number EPA–
HQ–OLEM–2023–0416, to EPA online
using www.regulations.gov (our
preferred method), or by mail to: EPA
Docket Center, Environmental
Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW,
Washington, DC 20460. EPA’s policy is
that all comments received will be
included in the public docket without
change including any personal
information provided, unless the
comment includes profanity, threats,
information claimed to be Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute.
FOR FURTHER INFORMATION CONTACT:
Hannah Blaufuss, Resource
Conservation and Sustainability
Division, Office of Resource
Conservation and Recovery, 5306P,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460; telephone number: 202–564–
5614; email address: Blaufuss.hannah@
epa.gov.
SUPPLEMENTARY INFORMATION: This is a
request for approval of a new collection.
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.
This notice allows 60 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.
Pursuant to section 3506(c)(2)(A) of
the PRA, EPA is soliciting comments
and information to enable it to: (i)
Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Agency, including
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21:46 Sep 28, 2023
Jkt 259001
whether the information will have
practical utility; (ii) evaluate the
accuracy of the Agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(iii) enhance the quality, utility, and
clarity of the information to be
collected; and (iv) minimize the burden
of the collection of information on those
who are to respond, including through
the use of appropriate forms of
information technology. EPA will
consider the comments received and
amend the ICR as appropriate. The final
ICR package will then be submitted to
OMB for review and approval. At that
time, EPA will issue another Federal
Register notice to announce the
submission of the ICR to OMB and the
opportunity to submit additional
comments to OMB.
Abstract: EPA’s Office of Land and
Emergency Management, Office of
Resource Conservation and Recovery
(ORCR) is charged with, among other
responsibilities, ensuring efficient and
equitable non-hazardous waste
management. In this capacity, timely
and consistent information on waste/
materials generation, disposition and
recovery is essential to ensure that
programs, policies, and grant monies are
properly targeted. Several statutes
mandate EPA to implement grants and
programs that will be supported by this
Information Collection Request (ICR).
Those statutes include the Save our Seas
2.0 Act (SOS 2.0) (Pub. L. 116–224), the
Infrastructure Investment and Jobs Act
(IIJA) (Pub. L. 117–58) and the Resource
Conservation and Recovery Act (RCRA)
42 U.S.C. 6983. EPA is mandated to
meet certain reporting requirements as
part of the grant programs established in
SOS 2.0 and IIJA. The creation of two
new grant programs in ORCR requires
efficiency to effectively manage the new
work. Under this ICR, a new knowledge
management system will be developed
to manage the post-award grant
reporting that is mandatory for grant
recipients’ reporting requirements under
SOS 2.0 and IIJA. This system will assist
staff in organizing quarterly reports to
measure impact and report to Congress.
Information collected under this ICR
also will illustrate progress toward the
National Recycling Goal to increase the
nation’s recycling rate to 50% by 2030
and the U.S. 2030 Food Loss and Waste
Reduction Goal to cut food loss and
waste in half by the year 2030. This ICR
encompasses EPA activities under the
National Recycling Strategy to
characterize materials management
infrastructure, standardize measurement
and increase data collection, and update
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the Facts and Figures on Materials,
Wastes and Recycling Report. This ICR
also will support activities associated
with future strategies EPA may release
as part of the series on building a
circular economy for all, including the
National Strategy to Prevent Plastic
Pollution. To track progress on the
implementation of these strategies and
goals, EPA requires current, accurate,
and evolving data on national waste
management pathways, including
recycling participation and food loss
and waste generation rates. Without
data collection, tracking progress relies
upon predictive modelling that may be
insufficiently accurate and precise when
definitiveness is key. Lastly, this ICR
also will support working with EPA’s
Office of Research and Development,
and potentially the National Center for
Environmental Economics, to integrate
Waste Input-Output modeling and the
U.S. Environmentally-Extended InputOutput model as the basis for future
Facts and Figures data estimates.
Form numbers: None.
Respondents/affected entities: To be
determined.
Respondent’s obligation to respond:
voluntary for general surveys and
mandatory for grant recipients’ per
reporting requirements under SOS 2.0
and IIJA.
Estimated number of respondents: To
be determined.
Frequency of response: To be
determined.
Total estimated burden: To be
determined.
Total estimated cost: To be
determined.
Dated: September 24, 2023.
Carolyn Hoskinson,
Director, Office of Resource Conservation and
Recovery.
[FR Doc. 2023–21326 Filed 9–28–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2023–0265; FRL–11109–
01–OCSPP]
Tris(2-chloroethyl) Phosphate (TCEP);
Draft Risk Evaluation under the Toxic
Substances Control Act (TSCA); Letter
Peer Review; Request for Nominations
of Expert Reviewers
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) is seeking public
nominations of scientific and technical
SUMMARY:
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Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices
experts to review the draft Risk
Evaluation for Tris(2-chloroethyl)
Phosphate (TCEP) conducted under the
Toxic Substances Control Act (TSCA).
The draft risk evaluation will be
released for public review and comment
in December 2023 through a separate
Federal Register document and
subsequently submitted for letter peer
review by the expert reviewers.
DATES: Nominations should be
submitted in time to arrive no later
October 30, 2023.
ADDRESSES: Submit your nominations to
the Peer Review Leader listed under FOR
FURTHER INFORMATION CONTACT. Do not
electronically submit any information
you consider to be Confidential
Business Information (CBI) or other
information whose public disclosure is
restricted by statute. If your nomination
may contain any such information,
please contact the Peer Review Leader
to obtain special instructions before
submitting that information.
FOR FURTHER INFORMATION CONTACT:
Contact the Peer Review Leader, 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; email address: kamel.alaa@
epa.gov or call the main office: (202)
564–8450.
SUPPLEMENTARY INFORMATION:
I. General Information
lotter on DSK11XQN23PROD with NOTICES1
A. What action is the Agency taking?
The Agency is seeking public
nominations of scientific and technical
experts that the EPA can consider for
service as peer reviewers for the review
of the ‘‘2023 Draft Risk Evaluation for
Tris(2-chloroethyl) Phosphate (TCEP).’’
EPA will be soliciting comments from
the reviewers on the approach and
methodologies utilized in the draft 2023
TCEP risk evaluation.
This document provides instructions
for submitting nominations for EPA to
consider for reviewers. EPA will publish
a separate document in the Federal
Register in December 2023 to announce
the availability of the draft risk
evaluation and solicit public comments.
B. What is the Agency’s authority for
taking this action?
TSCA section 6(b) requires that EPA
conduct risk evaluations on existing
chemical substances and identifies the
minimum components EPA must
include in all chemical substance risk
evaluations (15 U.S.C. 2605(b)). The risk
evaluation must not consider costs or
other non-risk factors (15 U.S.C.
2605(b)(4)(F)(iii)). The specific risk
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21:46 Sep 28, 2023
Jkt 259001
evaluation process is set out in 40 CFR
part 702 and summarized on EPA’s
website at https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca/risk-evaluations-existingchemicals-under-tsca.
C. Does this action apply to me?
This action is directed to the public
in general. This action may, however, be
of 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 regulated under TSCA. Since
other entities may also be interested, the
Agency has not attempted to describe all
the specific entities that may be affected
by this action.
II. Nominations for Peer Reviewers
A. Why is EPA seeking nominations for
peer reviewers?
As part of a broader process for
developing a pool of candidates for peer
reviews, EPA is asking the public and
stakeholder communities for
nominations of scientific and technical
experts that EPA can consider as
prospective candidates to serve as peer
reviewers. 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 asked
to review the draft risk evaluation for
TCEP and to help finalize the Letter
Review report.
B. What expertise is sought for this peer
review?
Individuals nominated for this peer
review, should have expertise in one or
more of the following areas:
environmental fate assessment;
environmental hazard assessment;
human health toxicology with
experience in cancer mode of action,
reproductive toxicology,
neurotoxicology, and renal toxicology;
dose-response modeling;
physiologically based pharmacokinetic
(PBPK) modeling; and human or
environmental exposure assessment,
especially for susceptible life stages and
subpopulations to environmental
contaminants, and experience with
particle versus gaseous partitioning and
air deposition of semi-volatile organic
compounds (SVOCs). Nominees should
be scientists who have sufficient
professional qualifications, including
training and experience, to be capable of
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67279
providing expert comments on the
scientific issues for this review.
C. How do I make a nomination?
By the deadline indicated under
DATES, submit your nomination to the
Peer Review Leader listed under FOR
FURTHER INFORMATION CONTACT. Each
nomination should include the
following: 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?
Peer 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 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.
E. How will EPA select peer reviewers?
The selection of scientists to serve as
peer reviewers is based on the expertise
needed to address the Agency’s charge
to the reviewers. No interested scientists
shall be ineligible to serve by reason of
their membership on any 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 Letter Review, 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 as a
peer reviewer.
Numerous qualified candidates are
often identified for the review.
E:\FR\FM\29SEN1.SGM
29SEN1
67280
Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices
Therefore, selection decisions involve
carefully weighing a number of 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 peer reviewers that are
received on or before the date listed in
the DATES section of this document.
However, the final selection of peer
reviewers is a discretionary function of
the Agency. At this time, EPA
anticipates selecting 10–12 reviewers in
the review of the designated topic.
EPA plans to make a list of candidates
under consideration as prospective peer
reviewers for this review available for
public comment by late fall of 2023. The
list will be available in the docket at
https://www.regulations.gov (docket ID
number EPA–HQ–OPPT–2023–0265).
III. Letter Review
lotter on DSK11XQN23PROD with NOTICES1
A. What is the purpose of this Letter
Review?
The focus of this Letter Review is to
review the approach and methodologies
utilized in the ‘‘2023 Draft Risk
Evaluation for Tris(2-chloroethyl)
Phosphate (TCEP).’’ Feedback from this
review will be considered in the
development of the final TCEP risk
evaluation.
EPA intends to announce in
December 2023, in the Federal Register,
the availability of and solicit public
comment on the draft risk evaluation, at
which time EPA will provide
instructions for submitting public
comments for the Agency’s and Letter
Peer Reviewers’ consideration.
B. Why did EPA develop these
documents?
TCEP is a High-Priority substance
undergoing the TSCA risk evaluation
process after passage of the Frank R.
Lautenberg Chemical Safety for the 21st
Century Act, which amended TSCA.
TCEP has been primarily used in
paint and coating manufacturing, and in
polymers used in aerospace equipment
and products. In the past it has also
been used in commercial and consumer
products, including fabric and textile,
products, foam seating, and
construction materials. TCEP may also
be imported in articles intended for
consumer use.
In August 2020, EPA published a final
scope document for 20 High-Priority
substances, including TCEP, outlining
the hazards, exposures, conditions of
use, and the potentially exposed or
susceptible subpopulations the Agency
expects to consider in its risk
evaluation.
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21:46 Sep 28, 2023
Jkt 259001
EPA is submitting the ‘‘2023 Draft
Risk Evaluation for Tris(2-chloroethyl)
Phosphate (TCEP)’’ and associated
supporting documents for Letter Peer
Review. The Letter Peer Review will
include review of the analysis of
physical chemical properties, the fate of
TCEP in the environment, releases of
TCEP 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. Specifically, EPA is seeking
comment on the following issues:
• The list of considerations EPA used
to arrive at the human health hazard
confidence levels and the specific
confidence levels chosen for individual
human health hazard outcome
(neurotoxicity, reproductive/
developmental effects, kidney effects,
and cancer) in the TCEP risk evaluation.
• Whether the approach used to
estimate anaerobic degradation in the
absence of data is appropriate for
assessing anaerobic degradation in
sediment.
• Use of the model, Web-based
Interspecies Correlation Estimation
(Web-ICE), to predict acute toxicity
hazard values for aquatic species not
represented in the available studies.
This is the first time EPA has used WebICE in a TSCA risk evaluation. These
predictions were used with available
empirical data to create a Species
Sensitivity Distribution (SSD). The SSD
was used to calculate a hazardous
concentration for 5% of species (HC05).
EPA is also using a data-driven way of
accounting for uncertainty for
environmental hazard and is soliciting
comment on its characterization of this
uncertainty, specifically its use of the
lower bound of the 95% confidence
interval of the hazardous HC05.
• Human health hazard benchmark
dose modeling of animal toxicity data
for TCEP.
• The list of considerations EPA used
to arrive at the human health hazard
confidence levels and the specific
confidence levels chosen for individual
human health hazard outcomes
(neurotoxicity, reproductive/
developmental effects, kidney effects,
and cancer) to quantitatively evaluate
risk from TCEP.
• Use of several approaches for
estimating exposures to humans and
environmental receptors: (1) The use of
Verner 2008 Multi-compartment model,
which was used to assess TCEP
exposure to infants through human milk
for the first time in a TSCA risk
evaluation; (2) the use of Verner 2008
Multi-compartment model and
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Fmt 4703
Sfmt 4703
associated uncertainties in extrapolating
from the inhalation to oral routes of
exposure; (3) the use of AERMOD model
to estimate air deposition of TCEP. EPA
has used AERMOD in previous TSCA
risk evaluations; however, its use in
estimating air deposition is novel for
TSCA risk evaluations.
• Approach for modeling drinking
water contamination from wells near
municipal solid waste landfills, which
is a new approach for TSCA risk
evaluations.
C. How can I access the documents
submitted for review to the SACC?
EPA is planning to release the ‘‘2023
Draft Risk Evaluation for Tris(2chloroethyl) Phosphate (TCEP)’’ and all
background documents, related
supporting materials, and draft charge
questions in December 2023. At that
time, EPA will publish a separate
document in the Federal Register to
announce the availability of and solicit
public comment on the draft risk
evaluation and provide instructions for
submitting written comments. These
materials will be available in the docket
at https://www.regulations.gov (docket
ID number EPA–HQ–OPPT–2023–0265)
and through the TSCA Scientific Peer
Review Committees website. In
addition, as additional background
materials become available, EPA will
include those additional background
documents (e.g., reviewers participating
in this letter review) in the docket and
through the website.
Authority: 15 U.S.C. 2625(h).
Dated: September 26, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2023–21544 Filed 9–28–23; 8:45 am]
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FARM CREDIT ADMINISTRATION
Sunshine Act Meetings
10 a.m., Thursday,
October 12, 2023.
PLACE: You may observe the open
portions of this meeting in person at
1501 Farm Credit Drive, McLean,
Virginia 22102–5090, or virtually. If you
would like to observe, at least 24 hours
in advance, visit FCA.gov, select
‘‘Newsroom,’’ then select ‘‘Events.’’
From there, access the linked
‘‘Instructions for board meeting visitors’’
and complete the described registration
process.
STATUS: Parts of this meeting will be
open to the public. The rest of the
meeting will be closed to the public.
TIME AND DATE:
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67278-67280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21544]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0265; FRL-11109-01-OCSPP]
Tris(2-chloroethyl) Phosphate (TCEP); Draft Risk Evaluation under
the Toxic Substances Control Act (TSCA); Letter Peer Review; Request
for Nominations of Expert Reviewers
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is seeking public
nominations of scientific and technical
[[Page 67279]]
experts to review the draft Risk Evaluation for Tris(2-chloroethyl)
Phosphate (TCEP) conducted under the Toxic Substances Control Act
(TSCA). The draft risk evaluation will be released for public review
and comment in December 2023 through a separate Federal Register
document and subsequently submitted for letter peer review by the
expert reviewers.
DATES: Nominations should be submitted in time to arrive no later
October 30, 2023.
ADDRESSES: Submit your nominations to the Peer Review Leader listed
under FOR FURTHER INFORMATION CONTACT. Do not electronically submit any
information you consider to be Confidential Business Information (CBI)
or other information whose public disclosure is restricted by statute.
If your nomination may contain any such information, please contact the
Peer Review Leader to obtain special instructions before submitting
that information.
FOR FURTHER INFORMATION CONTACT: Contact the Peer Review Leader, 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;
email address: [email protected] or call the main office: (202) 564-
8450.
SUPPLEMENTARY INFORMATION:
I. General Information
A. What action is the Agency taking?
The Agency is seeking public nominations of scientific and
technical experts that the EPA can consider for service as peer
reviewers for the review of the ``2023 Draft Risk Evaluation for
Tris(2-chloroethyl) Phosphate (TCEP).'' EPA will be soliciting comments
from the reviewers on the approach and methodologies utilized in the
draft 2023 TCEP risk evaluation.
This document provides instructions for submitting nominations for
EPA to consider for reviewers. EPA will publish a separate document in
the Federal Register in December 2023 to announce the availability of
the draft risk evaluation and solicit public comments.
B. What is the Agency's authority for taking this action?
TSCA section 6(b) requires that EPA conduct risk evaluations on
existing chemical substances and identifies the minimum components EPA
must include in all chemical substance risk evaluations (15 U.S.C.
2605(b)). The risk evaluation must not consider costs or other non-risk
factors (15 U.S.C. 2605(b)(4)(F)(iii)). The specific risk evaluation
process is set out in 40 CFR part 702 and summarized on EPA's website
at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.
C. Does this action apply to me?
This action is directed to the public in general. This action may,
however, be of 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 regulated under TSCA. Since other entities may also
be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action.
II. Nominations for Peer Reviewers
A. Why is EPA seeking nominations for peer reviewers?
As part of a broader process for developing a pool of candidates
for peer reviews, EPA is asking the public and stakeholder communities
for nominations of scientific and technical experts that EPA can
consider as prospective candidates to serve as peer reviewers. 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 asked to review the draft risk evaluation for TCEP and to help
finalize the Letter Review report.
B. What expertise is sought for this peer review?
Individuals nominated for this peer review, should have expertise
in one or more of the following areas: environmental fate assessment;
environmental hazard assessment; human health toxicology with
experience in cancer mode of action, reproductive toxicology,
neurotoxicology, and renal toxicology; dose-response modeling;
physiologically based pharmacokinetic (PBPK) modeling; and human or
environmental exposure assessment, especially for susceptible life
stages and subpopulations to environmental contaminants, and experience
with particle versus gaseous partitioning and air deposition of semi-
volatile organic compounds (SVOCs). 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?
By the deadline indicated under DATES, submit your nomination to
the Peer Review Leader listed under FOR FURTHER INFORMATION CONTACT.
Each nomination should include the following: 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?
Peer 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 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.
E. How will EPA select peer reviewers?
The selection of scientists to serve as peer reviewers is based on
the expertise needed to address the Agency's charge to the reviewers.
No interested scientists shall be ineligible to serve by reason of
their membership on any 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
Letter Review, 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 as a peer reviewer.
Numerous qualified candidates are often identified for the review.
[[Page 67280]]
Therefore, selection decisions involve carefully weighing a number of
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 peer reviewers that are
received on or before the date listed in the DATES section of this
document. However, the final selection of peer reviewers is a
discretionary function of the Agency. At this time, EPA anticipates
selecting 10-12 reviewers in the review of the designated topic.
EPA plans to make a list of candidates under consideration as
prospective peer reviewers for this review available for public comment
by late fall of 2023. The list will be available in the docket at
https://www.regulations.gov (docket ID number EPA-HQ-OPPT-2023-0265).
III. Letter Review
A. What is the purpose of this Letter Review?
The focus of this Letter Review is to review the approach and
methodologies utilized in the ``2023 Draft Risk Evaluation for Tris(2-
chloroethyl) Phosphate (TCEP).'' Feedback from this review will be
considered in the development of the final TCEP risk evaluation.
EPA intends to announce in December 2023, in the Federal Register,
the availability of and solicit public comment on the draft risk
evaluation, at which time EPA will provide instructions for submitting
public comments for the Agency's and Letter Peer Reviewers'
consideration.
B. Why did EPA develop these documents?
TCEP is a High-Priority substance undergoing the TSCA risk
evaluation process after passage of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, which amended TSCA.
TCEP has been primarily used in paint and coating manufacturing,
and in polymers used in aerospace equipment and products. In the past
it has also been used in commercial and consumer products, including
fabric and textile, products, foam seating, and construction materials.
TCEP may also be imported in articles intended for consumer use.
In August 2020, EPA published a final scope document for 20 High-
Priority substances, including TCEP, outlining the hazards, exposures,
conditions of use, and the potentially exposed or susceptible
subpopulations the Agency expects to consider in its risk evaluation.
EPA is submitting the ``2023 Draft Risk Evaluation for Tris(2-
chloroethyl) Phosphate (TCEP)'' and associated supporting documents for
Letter Peer Review. The Letter Peer Review will include review of the
analysis of physical chemical properties, the fate of TCEP in the
environment, releases of TCEP 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. Specifically, EPA is seeking comment on the
following issues:
The list of considerations EPA used to arrive at the human
health hazard confidence levels and the specific confidence levels
chosen for individual human health hazard outcome (neurotoxicity,
reproductive/developmental effects, kidney effects, and cancer) in the
TCEP risk evaluation.
Whether the approach used to estimate anaerobic
degradation in the absence of data is appropriate for assessing
anaerobic degradation in sediment.
Use of the model, Web-based Interspecies Correlation
Estimation (Web-ICE), to predict acute toxicity hazard values for
aquatic species not represented in the available studies. This is the
first time EPA has used Web-ICE in a TSCA risk evaluation. These
predictions were used with available empirical data to create a Species
Sensitivity Distribution (SSD). The SSD was used to calculate a
hazardous concentration for 5% of species (HC05). EPA is
also using a data-driven way of accounting for uncertainty for
environmental hazard and is soliciting comment on its characterization
of this uncertainty, specifically its use of the lower bound of the 95%
confidence interval of the hazardous HC05.
Human health hazard benchmark dose modeling of animal
toxicity data for TCEP.
The list of considerations EPA used to arrive at the human
health hazard confidence levels and the specific confidence levels
chosen for individual human health hazard outcomes (neurotoxicity,
reproductive/developmental effects, kidney effects, and cancer) to
quantitatively evaluate risk from TCEP.
Use of several approaches for estimating exposures to
humans and environmental receptors: (1) The use of Verner 2008 Multi-
compartment model, which was used to assess TCEP exposure to infants
through human milk for the first time in a TSCA risk evaluation; (2)
the use of Verner 2008 Multi-compartment model and associated
uncertainties in extrapolating from the inhalation to oral routes of
exposure; (3) the use of AERMOD model to estimate air deposition of
TCEP. EPA has used AERMOD in previous TSCA risk evaluations; however,
its use in estimating air deposition is novel for TSCA risk
evaluations.
Approach for modeling drinking water contamination from
wells near municipal solid waste landfills, which is a new approach for
TSCA risk evaluations.
C. How can I access the documents submitted for review to the SACC?
EPA is planning to release the ``2023 Draft Risk Evaluation for
Tris(2-chloroethyl) Phosphate (TCEP)'' and all background documents,
related supporting materials, and draft charge questions in December
2023. At that time, EPA will publish a separate document in the Federal
Register to announce the availability of and solicit public comment on
the draft risk evaluation and provide instructions for submitting
written comments. These materials will be available in the docket at
https://www.regulations.gov (docket ID number EPA-HQ-OPPT-2023-0265)
and through the TSCA Scientific Peer Review Committees website. In
addition, as additional background materials become available, EPA will
include those additional background documents (e.g., reviewers
participating in this letter review) in the docket and through the
website.
Authority: 15 U.S.C. 2625(h).
Dated: September 26, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-21544 Filed 9-28-23; 8:45 am]
BILLING CODE 6560-50-P
