Notice2024-14492
1,1-Dichloroethane and 1,2-Dichloroethane; Science Advisory Committee on Chemicals (SACC) Peer Review; Notice of SACC Meeting, Availability of Draft Documents and Request for Comment
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Published
July 2, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or "Agency") is announcing the availability of and soliciting public comment on the draft risk evaluation for 1,1-dichloroethane and the draft human health hazard technical support document for 1,2-dichloroethane (also known as ethylene dichloride). The draft documents were prepared under the Toxic Substances Control Act (TSCA) and will be submitted to the Science Advisory Committee on Chemicals (SACC) for peer review. EPA is also announcing that there will be two virtual public meetings of the SACC: On August 27, 2024, a preparatory meeting for the SACC to consider the scope and clarity of the draft charge questions for the peer review; and on September 17 through 20, 2024, the peer review meeting for the SACC to consider the draft documents and public comments.
Full Text
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<title>Federal Register, Volume 89 Issue 127 (Tuesday, July 2, 2024)</title>
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[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54815-54818]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-14492]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0114; FRL-11809-03-OCSPP]
1,1-Dichloroethane and 1,2-Dichloroethane; Science Advisory
Committee on Chemicals (SACC) Peer Review; Notice of SACC Meeting,
Availability of Draft Documents and Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is
announcing the availability of and soliciting public comment on the
draft risk evaluation for 1,1-dichloroethane and the draft human health
hazard technical support document for 1,2-dichloroethane (also known as
ethylene dichloride). The draft documents were prepared under the Toxic
Substances Control Act (TSCA) and will be submitted to the Science
Advisory Committee on Chemicals (SACC) for peer review. EPA is also
announcing that there will be two virtual public meetings of the SACC:
On August 27, 2024, a preparatory meeting for the SACC to consider the
scope and clarity of the draft charge questions for the peer review;
and on September 17 through 20, 2024, the peer review meeting for the
SACC to consider the draft documents and public comments.
DATES:
Preparatory Public Meeting
Meeting date: August 27, 2024, 1:00 p.m. to approximately 4:00 p.m.
(EDT).
Comments: Submit written comments on the scope and clarity of the
charge questions on or before noon (12:00 p.m. EDT) on August 23, 2024.
Registration: To request time to present oral comments during the
preparatory meeting, you must register by noon (12:00 p.m. EDT) on
August 23, 2024. For those not making oral comments, registration will
remain open through the end of the meeting on August 27, 2024.
SACC Peer Review Public Meeting
Meeting dates: September 17 through 20, 2024, 10:00 a.m. to
approximately 5:00 p.m. (EDT).
Comments: Submit written comments on the draft documents on or
before September 3, 2024.
Registration: To request time to present oral comments during the
peer review meeting, you must register by noon, September 10, 2024. For
those not making oral comments, registration will remain open through
the end of the meeting.
[[Page 54816]]
Special Accommodations: To allow sufficient time for EPA to process
your request for special accommodations before the meeting, please
submit the request at least ten business days in advance of the
meeting.
ADDRESSES:
Comments: Submit written comments, identified by docket
identification (ID) number EPA-HQ-OPPT-2024-0114, 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>.
Meeting Registration: Online registration will be available
beginning in late July 2024. Please refer to the SACC website at
<a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a>. After registering, you will
receive the webcast and streaming service meeting links and audio
teleconference information.
Special accommodation requests: To request an accommodation for a
disability, please contact the Designated Federal Official (DFO) listed
under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT:
Designated Federal Official (DFO): Alie Muneer, Mission Support
Division (7602M), Office of Program Support, Office of Chemical Safety
and Pollution Prevention, Environmental Protection Agency; telephone
number: (202) 564-6369 or call the main office number: (202) 564-8450;
email address: <a href="/cdn-cgi/l/email-protection#5538203b3030277b34393c30153025347b323a23"><span class="__cf_email__" data-cfemail="28455d464d4d5a064944414d684d5849064f475e">[email protected]</span></a>.
Technical contact: Clara Hull, Existing Chemicals Risk Management
Division, Office of Pollution Prevention and Toxics, Office of Chemical
Safety and Pollution Prevention, Environmental Protection Agency;
telephone number: (202) 564-3954; email address: <a href="/cdn-cgi/l/email-protection#b4dcc1d8d89ad7d8d5c6d5f4d1c4d59ad3dbc2"><span class="__cf_email__" data-cfemail="177f627b7b39747b7665765772677639707861">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
EPA is announcing the availability of and soliciting public comment
on the draft risk evaluation for 1,1-dichloroethane and the draft human
health hazard technical support document for 1,2-dichloroethane. The
draft documents were prepared under the Toxic Substances Control Act
(TSCA) and will be submitted to the Science Advisory Committee on
Chemicals (SACC) for peer review. EPA is also announcing that there
will be two virtual public meetings of the SACC: On August 27, 2024, a
preparatory meeting for the SACC to consider the scope and clarity of
the draft charge questions for the peer review; and on September 17
through 20, 2024, the peer review meeting for the SACC to consider the
draft documents and public comments.
This document provides instructions for accessing the materials,
submitting written comments, and registering to provide oral comments
and attend the public meetings.
B. What is the Agency's authority for taking this action?
EPA established the SACC in 2016 in accordance with TSCA, 15 U.S.C.
2625(o), to provide independent advice and expert consultation with
respect to the scientific and technical aspects of issues relating to
the implementation of TSCA. The SACC operates in accordance with the
Federal Advisory Committee Act (FACA), 5 U.S.C. 10, and supports
activities under TSCA, 15 U.S.C. 2601 et seq., the Pollution Prevention
Act (PPA), 42 U.S.C. 13101 et seq., and other applicable statutes.
C. Does this action apply to me?
This action is directed to the public in general and may be of
particular interest to those involved in the manufacture, processing,
distribution, and disposal of the subject chemical substances, and/or
those interested in the assessment of risks involving chemical
substances and mixtures regulated under TSCA (including members of at-
risk communities, non-governmental organizations (NGOs), federal,
state, and local officials). Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be interested.
D. What should I consider as I submit my comments to EPA?
1. Submitting CBI. Do not submit CBI or other sensitive information
to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. To include
information in your comment 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.
2. Tips for preparing comments. When preparing and submitting your
comments, see <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>. See
also the instructions in Unit III.C.
E. How can I stay informed about SACC activities?
You may subscribe to the following listserv for alerts regarding
this and other SACC-related activities: <a href="https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101">https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101</a>.
II. Background
A. What is the purpose of the SACC?
The SACC provides independent advice and recommendations to the EPA
on the scientific and technical aspects of risk assessments,
methodologies, and pollution prevention measures and approaches for
chemicals regulated under TSCA. The SACC is composed of experts in
toxicology; environmental risk assessment; exposure assessment; and
related sciences (e.g., synthetic biology, pharmacology, biotechnology,
nanotechnology, biochemistry, biostatistics, physiologically based
pharmacokinetic (PBPK) modeling, computational toxicology,
epidemiology, environmental fate, and environmental engineering and
sustainability). When needed, the SACC committee will be assisted by ad
hoc reviewers with specific expertise in the topics under
consideration.
B. Why is EPA conducting these risk evaluations?
TSCA requires EPA to conduct risk evaluations on prioritized
chemical substances and allows chemical manufacturers to request an
EPA-conducted risk evaluation of a chemical substance (or category of
chemical substances) using the procedures established in 40 CFR 702.37.
TSCA also identifies the minimum components EPA must include in all
chemical substance risk evaluations. 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 ensure 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-
[[Page 54817]]
and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-
chemicals.
C. Why is EPA evaluating these chemical substances?
In 2020, EPA issued final scope documents for the 20 chemical
substances designated in December 2019 as High-Priority Substances for
the TSCA risk evaluation process, which included 1,1-dichloroethane and
1,2-dichloroethane. The final scope documents outline the hazards,
exposures, conditions of use, and the potentially exposed or
susceptible subpopulations the Agency expected to consider in its risk
evaluation for the substances (85 FR 55283, September 4, 2020 (FRL-
10013-90)).
1,1-Dichloroethane (CASRN 75-34-3) is a chlorinated solvent that is
manufactured and used primarily in industrial applications, such as a
reactant for the manufacture of other chemicals or as a laboratory
chemical. 1,2-dichloroethane (CASRN 107-06-2) is a colorless liquid,
with a pleasant, chloroform-like odor, that is highly flammable and
primarily used in plastic material manufacturing, specifically the
manufacture of vinyl chloride. The reported total production volume of
1,1-dichloroethane in 2016 and 2020 was between 100 million and one
billion pounds with a high percentage used for processing as a reactive
intermediate and a small percentage used for commercial use as a
laboratory chemical. The reported production volume of 1,2-
dichloroethane was between 20 and 30 billion lbs/year, and a high
percentage of the production volume is used for processing as a
reactive intermediate in the manufacture of vinyl chloride.
Given that the largest reported environmental releases of 1,1-
dichloroethane are to air, a major exposure pathway to 1,1-
dichloroethane is through releases to air. Based on its physical and
chemical properties including water solubility, vapor pressure, and
Henry's Law Constant, 1,1-dichloroethane released to air is expected to
remain primarily in air and 1,1-dichloroethane released to water will
remain in water as it is water soluble. Continuous releases of 1,1-
dichloroethane to water are expected to volatilize to air at rates
dependent on environmental conditions, however, a portion of 1,1-
dichloroethane will remain in the water column (maximum solubility is 5
g/liter). EPA, therefore, assessed relevant air, surface water, and
land exposure pathways. EPA relied on databases reporting multi-year
1,1-dichloroethane releases to ambient air, surface water, and disposal
to land, such as the Toxic Release Inventory (TRI), the National
Emissions Inventory (NEI) and Discharge Monitoring Reports (DMR), among
others, to conduct major portions of its exposure analysis.
Due to limited empirical data for human health and portions of the
environmental hazard assessments, EPA relied on read-across approaches
to supplement 1,1-dichloroethane data to propose hazard values.
Specifically, for the human health assessment of 1,1-dichloroethane,
EPA used 1,2-dichloroethane as an analog for a read-across method to
supplement the non-cancer and cancer hazard information for 1,1-
dichloroethane.
D. What is the topic of the planned SACC peer review?
EPA is submitting the draft risk evaluation of 1,1-dichloroethane,
draft human health hazard technical support document of 1,2-
dichloroethane, and associated supporting documents to the SACC for
peer review, along with the public comments received. The draft risk
evaluation for 1,1-dichloroethane includes analyses of physical-
chemical properties, the fate and transport in the environment,
exposure to workers and the general population including potentially
exposed or susceptible subpopulations, releases to the environment,
environmental hazard and risk characterization for terrestrial and
aquatic species, and human health hazard and risk characterization for
workers and the general population. EPA identified 1,2-dichloroethane
as an analog for reading across to 1,1-dichloroethane non-cancer and
cancer human health since EPA had limited non-cancer and cancer
empirical toxicity data available for 1,1- dichloroethane. EPA is
therefore submitting the draft human health hazard technical support
document for 1,2-dichloroethane for peer review. EPA is in the process
of preparing a draft risk evaluation for 1,2-dichloroethane that will
be released later for public comment and peer review. The 1,2-
dichloroethane human health hazard technical support document will also
accompany the 1,2-dichloroethane draft risk evaluation when it is
released for public comment but will not undergo additional peer review
since is currently being evaluated along with 1,1-dichloroethane.
EPA is focusing its peer review charge on specific scientific areas
and analyses. Many of the methods and analyses used in these
evaluations are not novel and have been reviewed in the development of
previous TSCA assessments. EPA is requesting feedback on approaches,
results and calculations associated with the exposure, human health
hazard and environmental hazard analyses. EPA is releasing the draft
risk evaluation for public comment and independent, expert peer review.
Once EPA receives comment and input from public comment and peer
review, revisions will be made, and the Agency will finalize the 1,1-
dichloroethane risk evaluation and incorporate information from the
1,2-dichloroethane draft human health hazard technical support document
into the 1,2-dichloroethane draft risk evaluation.
III. Public Meeting of the SACC
A. What is the purpose of the virtual public meeting(s)?
EPA is planning two virtual public meetings: (1) A preparatory
public meeting for the SACC to consider and ask questions regarding the
scope and clarity of the draft charge questions; and (2) a public peer
review meeting for the SACC to consider and peer review the draft
documents. These public meetings are part of the SACC's peer review of
the Agency's methods and novel analyses for the draft risk evaluation
of 1,1-dichloroethane and the draft human health hazard technical
support document of 1,2-dichloroethane. The agenda for these meetings
will be posted on the docket and will also be available through the
SACC website.
To participate in these virtual public meetings, you must register
online to receive the webcast and streaming service meeting links and
audio teleconference information for each meeting. Online registration
will be available beginning approximately one month prior to the
meeting and will remain open through the end of the meeting. To make
oral comments during one of these meetings, follow the instructions in
this document.
Recommendations from this SACC review and public comments will be
considered in the development of the TSCA risk evaluations for both
chemical substances and may inform other EPA efforts related to the
assessment and regulation of 1,1-dichloroethane and 1,2-dichloroethane.
The Agency will be seeking SACC review of its data analyses and
methodologies relevant to human health hazard and exposure analyses
that have not been previously peer-reviewed.
B. How can I access the documents?
The draft risk evaluation for 1,1-dichloroethane, draft human
health hazard technical support document for 1,2-dichloroethane, and
related documents, including background
[[Page 54818]]
documents, related supporting materials, and draft charge questions,
are available in the docket. As additional background materials become
available, EPA will include those additional background materials
(e.g., SACC members and consultants participating in this meeting and
the meeting agenda) in the docket and through links on the SACC website
at <a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a>.
After the public meeting, the SACC will prepare the meeting minutes
and final report document summarizing its recommendations to the EPA,
which will also be available in the docket and through the SACC
website.
C. How can I provide comments?
To ensure proper receipt of comments, it is imperative that you
identify docket ID No. EPA-HQ-OPPT-2024-0073 in the subject line on the
first page of your comments and follow the instructions in this
document.
1. Written comments. Submit written comments by the deadlines set
in the DATES section of this document and as described in the ADDRESSES
section of this document.
2. Oral comments. To request time to present oral comments during
one of the virtual public meetings, you must register online by the
deadlines set in the DATES section of this document. Oral comments
during the virtual public meetings are limited to 5 minutes. In
addition, each speaker should submit a written copy of their oral
comments and any supporting materials (e.g., presentation slides) to
the DFO prior to the meetings for distribution to the SACC.
Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10.
Dated: June 26, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-14492 Filed 7-1-24; 8:45 am]
BILLING CODE 6560-50-P
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