Document ID: EPA-HQ-OPPT-2018-0443-0033
Agency: epa
Document Type: Notice
Title: Final Scope of the Risk Evaluation To Be Conducted Under the Toxic Substances Control Act: Octamethylcyclotetra-siloxane (D4)
Posted Date: 2022-03-07T05:00Z

[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12696-12697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04676]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0443; FRL-8850-02-OCSPP]

Octamethylcyclotetra-siloxane (D4); Final Scope of the Risk 
Evaluation To Be Conducted Under the Toxic Substances Control Act 
(TSCA); Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In accordance with the Toxic Substances Control Act (TSCA) and 
implementing regulations, EPA is announcing the availability of the 
final scope of the risk evaluation to be conducted for 
octamethylcyclotetra-siloxane (D4) (Cyclotetrasiloxane, 
2,2,4,4,6,6,8,8-octamethyl-; Chemical Abstracts Service Registry Number 
(CASRN) 556-67-2), a chemical substance for which EPA received a 
manufacturer request for risk evaluation. The scope document 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.

ADDRESSES: The docket, identified by docket identification (ID) number 
EPA-HQ-OPPT-2018-0443, is available online at https://www.regulations.gov or in-person at the Office of Pollution Prevention 
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and docket access, 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 (e.g., entities identified under North 
American Industrial Classification System (NAICS) codes 325 and 
324110). The action may also be of interest to 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 final scope document is issued pursuant to TSCA section 
6(b)(4)(D) and TSCA implementing regulations at 40 CFR 702.41(c)(8).

C. What action is the Agency taking?

    EPA is publishing the final 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, 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 
(Ref. 1). On June 17, 2020, 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. 
Pursuant to 40 CFR 702.41(c)(7), EPA announced the availability of and 
sought public comment on the draft scope document for the risk 
evaluation to be conducted for D4 under TSCA (86 FR 50347, September 8, 
2021) (FRL-8850-01-OCSPP) (Ref. 2).
    The purpose of risk evaluation is to determine whether a chemical 
substance, or category of chemical substances, presents an unreasonable 
risk of injury 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 nonrisk factors; take into account, where relevant, likely 
duration, intensity, frequency, and number of exposures and describe 
the weight of the scientific evidence for hazards and exposures (15 
U.S.C. 2605(b)(4)(F)). This process will culminate in a determination 
of whether 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. Information and Comments Received on the Draft Scope

    In the Federal Register of September 8, 2021 (Ref. 2), EPA 
announced the availability of the draft scope document for the risk 
evaluation to be conducted for D4 under TSCA and invited public 
comments on EPA's draft scope document, including additional data or 
information relevant to the chemical substance or that otherwise could 
be useful to the Agency in finalizing the scope of the risk evaluation. 
To the extent that comments provided information on conditions of use, 
as well as other elements of the draft scope document, those comments 
and other submitted information (e.g., relevant studies, assessments, 
information on degradation products, and information on conditions of 
use) were used to inform revisions to the draft scope document and may 
be considered in

[[Page 12697]]

subsequent phases of the risk evaluation process.
    EPA received six unique submissions for D4, including comments from 
potentially affected businesses or trade associations, environmental 
and public health advocacy groups, and one member of the general 
public.
    Comments addressed the overall approach to the risk evaluation 
process (e.g., collection, consideration, and systematic review of 
relevant information), the specific elements of the scope document 
(e.g., hazard, exposure, and potentially exposed or susceptible 
subpopulations), information specific to the chemical substance (e.g., 
relevant studies, assessments, degradation products, and conditions of 
use), and topics beyond the draft scope document phase of the process 
(e.g., risk management). EPA considered those comments, as applicable 
and appropriate, in developing the final scope document. Concurrently 
with the publication of the final scope document, EPA is publishing a 
response to comments document that contains a comprehensive summary of 
and response to public comments received on the D4 draft scope 
document. The comprehensive response to comments document is available 
in the docket EPA-HQ-OPPT-2018-0443 (Ref. 3).

IV. References

    The following is a listing of the documents that are specifically 
referenced in this Federal Register notice. The docket for this action 
includes these documents and other information considered by EPA, 
including documents that are referenced within the documents that are 
included in the docket. For assistance in locating these referenced 
documents, please consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

1. EPA. Octamethylcyclotetra-Siloxane (D4); Manufacturer Request for 
Risk Evaluation Under the Toxic Substances Control Act (TSCA); 
Notice of Availability and Request for Comments. Federal Register. 
(85 FR 36586, June 17, 2020) (FRL-10010-49).
2. EPA. Octamethylcyclotetra-Siloxane (D4); Draft Scope of the Risk 
Evaluation to be Conducted Under the Toxic Substances Control Act 
(TSCA); Notice of Availability and Request for Comments. Federal 
Register. (86 FR 50347, September 8, 2021) (FRL-8850-01-OCSPP).
3. EPA. EPA Response to Public Comments Received on the Draft Scope 
of the Risk Evaluation for Under the Toxic Substances Control Act 
(TSCA) for Octamethylcyclotetra-siloxane (Cyclotetrasiloxane, 
2,2,4,4,6,6,8,8-octamethyl-) (D4) CASRN 556-67-2 (March 2022).

    Authority: 15 U.S.C. 2601 et seq.

Michael S. Regan,
Administrator.
[FR Doc. 2022-04676 Filed 3-4-22; 8:45 am]
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