Notice2021-19392
Octamethylcyclotetra-Siloxane (D4); Draft Scope of the Risk Evaluation To Be Conducted Under the Toxic Substances Control Act; Notice of Availability and Request for Comments
Primary source
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Published
September 8, 2021
Issuing agencies
Environmental Protection Agency
Abstract
In accordance with implementing regulations for the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on the draft scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4). D4 (Cyclotetrasiloxane, 2,2,4,4,6,6,8,8-octamethyl-; Chemical Abstracts Service Registry Number (CASRN) 556-67-2), is a chemical substance for which EPA received a manufacturer request for risk evaluation. The draft scope for this chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this chemical substance. EPA is also opening a 45-calendar day comment period on the draft scope to allow for the public to provide additional data or information that could be useful to the Agency in finalizing the scope of the risk evaluation; comments may be submitted to this docket.
Full Text
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<title>Federal Register, Volume 86 Issue 171 (Wednesday, September 8, 2021)</title>
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[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Notices]
[Pages 50347-50348]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19392]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0443; FRL-8850-01-OCSPP]
Octamethylcyclotetra-Siloxane (D4); Draft Scope of the Risk
Evaluation To Be Conducted Under the Toxic Substances Control Act;
Notice of Availability and Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: In accordance with implementing regulations for the Toxic
Substances Control Act (TSCA), the Environmental Protection Agency
(EPA) is announcing the availability of and soliciting public comment
on the draft scope of the risk evaluation to be conducted for
octamethylcyclotetra-siloxane (D4). D4 (Cyclotetrasiloxane,
2,2,4,4,6,6,8,8-octamethyl-; Chemical Abstracts Service Registry Number
(CASRN) 556-67-2), is a chemical substance for which EPA received a
manufacturer request for risk evaluation. The draft scope for this
chemical substance includes the conditions of use, hazards, exposures,
and the potentially exposed or susceptible subpopulations that EPA
plans to consider in conducting the risk evaluation for this chemical
substance. EPA is also opening a 45-calendar day comment period on the
draft scope to allow for the public to provide additional data or
information that could be useful to the Agency in finalizing the scope
of the risk evaluation; comments may be submitted to this docket.
DATES: Comments must be received on or before October 25, 2021.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0443, online using the Federal eRulemaking
Portal at <a href="http://www.regulations.gov">http://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
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets/about-epa-dockets">https://www.epa.gov/dockets/about-epa-dockets</a>.
Due to the public health emergency the EPA Docket Center (EPA/DC)
and Reading Room were closed to public visitors on March 31, 2020. Our
EPA/DC staff will continue to provide customer service via email,
phone, and webform. For further information on EPA/DC services, docket
contact information and the current status of the EPA/DC and Reading
Room, please visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Bethany Masten, Existing
Chemical Risk Management Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency (Mailcode 7404T), 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8803; email address: <a href="/cdn-cgi/l/email-protection#ff929e8c8b9a91d19d9a8b979e9186bf9a8f9ed1989089"><span class="__cf_email__" data-cfemail="264b4755524348084443524e47485f6643564708414950">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#9acec9d9dbb7d2f5eef6f3f4ffdaffeafbb4fdf5ec"><span class="__cf_email__" data-cfemail="f0a4a3b3b1ddb89f849c999e95b0958091de979f86">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general and may be of
interest to entities that manufacture (including import) a chemical
substance regulated under TSCA, 15 U.S.C. 2601 et seq., (e.g., entities
identified under North American Industrial Classification System
(NAICS) codes 325 and 324110). The action may also be of interest to
[[Page 50348]]
chemical processors, distributors in commerce, and users; non-
governmental organizations in the environmental and public health
sectors; state and local government agencies; and members of the
public. Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities and corresponding NAICS
codes for entities that may be interested in or affected by this
action.
B. What is the Agency's authority for taking this action?
The draft scope of the risk evaluation is issued pursuant to TSCA
implementing regulations at 40 CFR 702.41(c)(7).
C. What action is the Agency taking?
EPA is publishing and requesting public comment on the draft scope
of the risk evaluation for D4 under TSCA. Through the risk evaluation
process, EPA will determine whether the chemical substance presents an
unreasonable risk of injury to health or the environment under the
conditions of use, as determined by the Administrator, in accordance
with TSCA section 6(b)(4).
II. Background
TSCA allows chemical manufacturers to request an EPA-conducted risk
evaluation of a chemical substance under 40 CFR 702.37. On March 19,
2020, EPA received a manufacturer request for a risk evaluation of D4.
In the Federal Register notice of June 17, 2020 (85 FR 36586; FRL-
10010-49), EPA opened a 45-day public comment period to gather
information relevant to the requested risk evaluation. EPA granted the
request on October 6, 2020, and subsequently initiated the scoping
process for the risk evaluation for this chemical substance on November
5, 2020. The purpose of a risk evaluation is to determine whether a
chemical substance, or group of chemical substances, presents an
unreasonable risk to health or the environment, under the conditions of
use, including an unreasonable risk to a relevant potentially exposed
or susceptible subpopulation (15 U.S.C. 2605(b)(4)(A)). As part of this
process, EPA must evaluate both hazards and exposures for the
conditions of use; describe whether aggregate or sentinel exposures
were considered and the basis for consideration; not consider costs or
other non-risk factors; take into account where relevant, likely
duration, intensity, frequency, and number of exposures; and describe
the weight-of-scientific-evidence for hazards and exposures (15 U.S.C.
2605(b)(4)(F)). This process will culminate in a determination of
whether or not the chemical substance presents an unreasonable risk of
injury to health or the environment under the conditions of use (15
U.S.C. 2605(b)(4)(A); 40 CFR 702.47).
III. Draft Scope of the Risk Evaluation for Octamethylcyclotetra-
Siloxane (D4)
The chemical substance for which EPA is publishing the draft scope
of the risk evaluation is listed on the TSCA Inventory with CA Index
Name ``Cyclotetrasiloxane, 2,2,4,4,6,6,8,8-octamethyl-'' and the
associated Chemical Abstracts Service Registry Number (CASRN) 556-67-2.
The draft scope of the risk evaluation for this chemical substance
includes the conditions of use, hazards, exposures, and the potentially
exposed or susceptible subpopulations EPA plans to consider in the risk
evaluation (15 U.S.C. 2605(b)(4)(D)). Development of the scope is the
first step of a risk evaluation. The draft scope of the risk evaluation
will include the following components (40 CFR 702.41(c)):
<bullet> The conditions of use, as determined by the Administrator,
that EPA plans to consider in the risk evaluation.
<bullet> The potentially exposed populations that EPA plans to
evaluate; the ecological receptors that EPA plans to evaluate; and the
hazards to health and the environment that EPA plans to evaluate.
<bullet> A description of the reasonably available information and
the science approaches that the Agency plans to use.
<bullet> A conceptual model that will describe the actual or
predicted relationships between the chemical substance, the conditions
of use within the scope of the evaluation and the receptors, either
human or environmental, with consideration of the life cycle of the
chemical substance--from manufacturing, processing, distribution in
commerce, storage, use, to release or disposal--and identification of
human and ecological health hazards EPA plans to evaluate for the
exposure scenarios EPA plans to evaluate.
<bullet> An analysis plan, which will identify the approaches and
methods EPA plans to use to assess exposure, hazards, and risk,
including associated uncertainty and variability, as well as a strategy
for using reasonably available information and science approaches.
<bullet> A plan for peer review.
EPA encourages commenters to provide information they believe might
be missing or may further inform the risk evaluation. EPA will publish
a notice in the Federal Register announcing the availability of the
final scope of the risk evaluation within three months of publishing
the draft scope.
Authority: 15 U.S.C. 2601 et seq.
Michael S. Regan,
Administrator.
[FR Doc. 2021-19392 Filed 9-7-21; 8:45 am]
BILLING CODE 6560-50-P
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