[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Notices]
[Pages 50347-50348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 http://www.regulations.gov. 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 https://www.epa.gov/dockets/about-epa-dockets.
    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 https://www.epa.gov/dockets.

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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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)):
     The conditions of use, as determined by the Administrator, 
that EPA plans to consider in the risk evaluation.
     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.
     A description of the reasonably available information and 
the science approaches that the Agency plans to use.
     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.
     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.
     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]
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