Notice2023-27600
Tris(2-chloroethyl) Phosphate (TCEP); Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Letter Peer Review; Notice of Availability, Public Meeting and Request for Comment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 15, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on the document titled: "2023 Draft Risk Evaluation for Tris(2-chloroethyl) Phosphate (TCEP)" and related draft charge questions. EPA will be submitting the Draft Risk Evaluation and public comments to peer reviewers who will consider the approach and methodologies utilized. 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. The letter peer review is expected to begin on March 13, 2024, and end on April 12, 2024. A preparatory virtual public meeting will be held on March 5, 2024, for reviewers and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions. Feedback from the letter peer review will be considered in the development of the final TCEP risk evaluation.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 240 (Friday, December 15, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 240 (Friday, December 15, 2023)]
[Notices]
[Pages 86894-86896]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27600]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0265; FRL-11109-02-OCSPP]
Tris(2-chloroethyl) Phosphate (TCEP); Draft Risk Evaluation Under
the Toxic Substances Control Act (TSCA); Letter Peer Review; Notice of
Availability, Public Meeting and Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comment on the document titled:
``2023 Draft Risk Evaluation for Tris(2-chloroethyl) Phosphate (TCEP)''
and related draft charge questions. EPA will be submitting the Draft
Risk Evaluation and public comments to peer reviewers who will consider
the approach and methodologies utilized. 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. The letter peer review
is expected to begin on March 13, 2024, and end on April 12, 2024. A
preparatory virtual public meeting will be held on March 5, 2024, for
reviewers and the public to comment on and ask questions regarding the
scope and clarity of the draft charge questions. Feedback from the
letter peer review will be considered in the development of the final
TCEP risk evaluation.
DATES:
Virtual Public Meeting: March 5, 2024, 1-4 p.m. EST. To receive the
webcast meeting link and audio teleconference information before the
meeting, you must register by 5 p.m. EST on March 1, 2024.
Special Accommodations: To allow EPA time to process your request
for special accommodations, please submit the request by February 23,
2024.
Written Comments: Comments must be received on or before February
13, 2024.
ADDRESSES: Submit written comments identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0265, through <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 information on commenting or visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: The Peer Review Leader (PRL), Alaa
Kamel, Ph.D., Mission Support Division, Office of Program Support,
Office of Chemical Safety and Pollution Prevention, Environmental
Protection Agency;
[[Page 86895]]
telephone number: (202) 564-5336 or call the main office number: (202)
564-8450; email address: <a href="/cdn-cgi/l/email-protection#e388828e868fcd828f8282a3869382cd848c95"><span class="__cf_email__" data-cfemail="8ae1ebe7efe6a4ebe6ebebcaeffaeba4ede5fc">[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 document titled: ``2023 Draft Risk Evaluation for Tris(2-
chloroethyl) Phosphate (TCEP)''. A letter peer review is expected to
begin on March 13, 2024, and end on April 12, 2024, to review the
approach and methodologies utilized in this document. A preparatory
virtual public meeting will be held on March 5, 2024, for reviewers and
the public to comment on and ask questions regarding the scope and
clarity of the draft charge questions.
B. What is the Agency's authority for taking this action?
Section 6(b) of the Toxic Substances Control Act (TSCA) (15 U.S.C.
2605(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. 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 <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca</a>.
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.
D. What should I consider as I submit my comments to EPA?
1. Submitting Confidential Business Information (CBI).
Do not submit CBI or other sensitive information to EPA through
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you'd like to include
information in your comment that you consider to be CBI or otherwise
protected, please contact the PRL listed under FOR FURTHER INFORMATION
CONTACT to obtain special instructions before submitting that
information.
2. Tips for preparing comments. When preparing and submitting your
comments, see Tips for Effective Comments at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Request for Comment
EPA is seeking public comment on both the draft risk evaluation and
the draft charge questions for the letter peer review. Both documents
are available in EPA Docket ID No. EPA-HQ-OPPT-2023-0265 at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and may also be accessed through EPA's website at
<a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a>. As additional background
materials become available, EPA will include those additional
background documents (e.g., reviewers participating in this letter peer
review) in the docket and on the website.
III. Preparatory Meeting
EPA will publish instructions on how to register for the virtual
public meeting that will be held on March 5, 2024, from 1-4 p.m. EST.
After registering, you will receive the webcast meeting link and audio
teleconference information for this public meeting. You may register
and participate as a listen-only attendee at any time up to the end of
the meeting on March 5, 2024. Requests to make brief (up to five
minutes) oral comments during the preparatory meeting can be submitted
when registering and will be accepted until Friday, March 1, 2024.
IV. Letter Peer Review
A. What is the purpose of this Letter Peer Review?
The focus of this Letter Peer Review is on 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.
B. Why did EPA develop these documents?
TCEP is a High-Priority substance undergoing the TSCA risk
evaluation process. 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:
<bullet> 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) in the
TCEP risk evaluation.
<bullet> Whether the approach used to estimate anaerobic
degradation in the absence of data is appropriate for assessing
anaerobic degradation in sediment.
<bullet> 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
(HC<INF>05</INF>). 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
HC<INF>05</INF>.
<bullet> Human health hazard benchmark dose modeling of animal
toxicity data for TCEP.
<bullet> 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.
<bullet> Use of several approaches for estimating exposures to
humans and
[[Page 86896]]
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 the American Meteorological Society/Environmental Protection
Agency Regulatory Model (AERMOD) 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.
<bullet> 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?
The ``2023 Draft Risk Evaluation for Tris(2-chloroethyl) Phosphate
(TCEP)'' and all background documents, related supporting materials,
and draft charge questions are available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
in Docket ID No. EPA-HQ-OPPT-2023-0265 and through the TSCA Scientific
Peer Review Committees website at <a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a>.
In addition, as additional background materials become available (e.g.,
reviewers participating in the letter peer review), EPA will include
those additional background documents in the docket and through the
website.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 12, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-27600 Filed 12-14-23; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 15, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.