Document ID: EPA-HQ-OPPT-2018-0443-0002
Agency: epa
Document Type: Notice
Title: Manufacturer Request for Risk Evaluation under the Toxic Substances Control Act: Octamethylcyclotetra-siloxane (D4)
Posted Date: 2020-06-17T04:00Z

[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36586-36588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13037]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0443; FRL-10010-49]

Octamethylcyclotetra-siloxane (D4); Manufacturer Request for Risk 
Evaluation Under the Toxic Substances Control Act (TSCA); Notice of 
Availability and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of and soliciting public 
comment on a manufacturer request for a risk evaluation of 
octamethylcyclotetra-siloxane (D4) under the Toxic Substances Control 
Act (TSCA). The request was made by Dow Silicones Corporation, Elkem 
Silicones USA Corporation, Evonik Corporation, Momentive Performance 
Materials,

[[Page 36587]]

Shin-Etsu Silicones of America, Inc.; and Wacker Chemical Corporation 
through the American Chemistry Council's Silicones Environmental, 
Health, and Safety Center (SEHSC). EPA conducts risk evaluations to 
determine whether a chemical substance presents an unreasonable risk of 
injury to health or the environment without consideration of costs or 
other non-risk factors, including an unreasonable risk to potentially 
exposed or susceptible subpopulations, under the conditions of use. In 
the docket associated with this request is the manufacturer request for 
an EPA-conducted risk evaluation and possible additional conditions of 
use EPA has identified for inclusion within the scope of a risk 
evaluation of D4. After considering comments received in response to 
this solicitation, EPA will determine whether to grant or deny the 
manufacturer request. All TSCA risk evaluations, whether EPA-initiated 
or manufacturer-requested, will be conducted in the same manner.

DATES: Comments must be received on or before August 3, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0443, by one of the following methods:
     Federal eRulemaking Portal: 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.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Please note that 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, National Program 
Chemicals Division, Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, Mail Code 7404T, 1200 Pennsylvania 
Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-8803; 
email address: masten.bethany@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this apply to me?

    This notice is directed to the public in general and may be of 
interest to persons who currently or may manufacture (including 
import), process, distribute, use, and/or dispose of D4. Since other 
entities may also be interested in these risk evaluations, EPA has not 
attempted to describe all the specific entities that may be affected by 
this action.

B. What is EPA's authority for taking this action?

    TSCA section 6(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. 15 U.S.C. 
2605(b). 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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.
    TSCA section 6(b) also allows manufacturers of a chemical substance 
to request an EPA-conducted risk evaluation on the chemical substance. 
TSCA required EPA to develop the form and manner under which these 
requests must be made, and the criteria for which EPA will determine 
whether to grant a request. These requirements and criteria are set out 
in 40 CFR 702.37.
    Under 40 CFR 702.37(e)(3), EPA is required to assess whether the 
circumstances identified in a manufacturer request for a risk 
evaluation constitute conditions of use (as defined under TSCA section 
(3)(4) and implementing regulations (40 CFR 702.33), and whether those 
conditions of use warrant inclusion within the scope of a risk 
evaluation for the chemical substance. EPA will also assess what, if 
any, additional conditions of use warrant inclusion within the scope of 
a risk evaluation for the chemical substance. EPA will conduct these 
assessments based on the same considerations applied in the same manner 
as it would for a risk evaluation in the EPA-initiated risk evaluation 
process.
    No later than 60 business days after receiving a manufacturer 
request for risk evaluation that EPA has determined to be facially 
complete (meeting the criteria set forth in 40 CFR 702.37(e)(1)), EPA 
is required to submit for publication the receipt of the request in the 
Federal Register, open a public docket for the request (which must 
contain the manufacturer request and EPA's possible additional 
conditions of use), and provide no less than 45 calendar days for 
public comment. This notice identifies the docket containing the 
manufacturer request, EPA's possible additional conditions of use, and 
the basis for including those possible additional conditions of use. 
During the public comment period, the public may submit comments and 
information relevant to the requested risk evaluation, as well as the 
additional possible conditions of use EPA is including in the docket.
    After the comment period closes, the Agency has up to 60 days to 
either grant or deny the request to conduct a risk evaluation under 40 
CFR 702.37(e)(6). EPA will review the request along with any additional 
information received during the comment period, and grant the request 
if it determines the request meets all of the following requirements 
listed under 40 CFR 702.37(e)(6)(ii):
     The circumstances identified in the request constitute 
conditions of use that warrant inclusion in a risk evaluation for the 
chemical substance;
     EPA has all the information needed to conduct such risk 
evaluation on the conditions of use that were the subject of the 
request; and
     All other criteria and requirements of 40 CFR 702.37 have 
been met.

C. What action is EPA taking?

    EPA is announcing the availability of and soliciting public comment 
on a manufacturer request for a risk evaluation of D4 under TSCA 
section 6(b) that is described in detail in Unit II. Also available in 
the docket associated with this request are the manufacturer request 
and possible additional conditions of use EPA identified for inclusion 
in a risk evaluation of D4. This notice satisfies 40 CFR 702.37(e)(4).

D. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that

[[Page 36588]]

you claim to be CBI. For CBI information in a disk or CD-ROM that you 
mail to EPA, mark the outside of the disk or CD-ROM as CBI and then 
identify electronically within the disk or CD-ROM the specific 
information that is claimed CBI. In addition to one complete version of 
the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Summary of This Manufacturer Request

    On March 19, 2020, EPA received a complete manufacturer request for 
a TSCA risk evaluation of D4 that was made by Dow Silicones 
Corporation, Elkem Silicones USA Corporation, Evonik Corporation, 
Momentive Performance Materials, Shin-Etsu Silicones of American, Inc.; 
and Wacker Chemical Corporation through the American Chemistry 
Council's Silicones Environmental, Health, and Safety Center (SEHSC). 
After determining the request was facially complete (i.e., EPA 
determined that the request appeared to be consistent with the 
requirements in 40 CFR 702.37(b) through (d), such as including all the 
necessary information in those paragraphs), EPA notified the public of 
the receipt of the request on April 8, 2020 via a listserv announcement 
to stakeholders.

A. What is octamethylcyclotetra-siloxane (D4)?

    D4 is used to make other silicone chemicals and as an ingredient in 
some personal care products. This substance 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.

B. What are the conditions of use?

    The manufacturer request for a risk evaluation of D4 identifying 
conditions of use of interest to the manufacturer is included in docket 
EPA-HQ-OPPT-2018-0443. Subject to further analysis and public comment, 
EPA anticipates including activities identified in the request as 
conditions of use in the risk evaluation of D4.
    EPA has identified additional conditions of use pursuant to 40 CFR 
702.37(e)(3), which are also included in docket EPA-HQ-OPPT-2018-0443.

III. Request for Comment

    The docket associated with this request contains the manufacturer 
request (excluding information claimed as CBI), EPA's possible 
additional conditions of use as described 40 CFR 702.37(e)(3), and the 
basis for these possible additions. During the comment period, the 
public may submit comments and information relevant to the requested 
risk evaluation; in particular, commenters are encouraged to identify 
any information not included in the request that the commenters believe 
would be needed to conduct a risk evaluation, and to provide any other 
information relevant to EPA's possible additional conditions of use, 
such as information on other conditions of use of the chemical 
substance than those included in the request or in EPA's possible 
additional conditions of use. 40 CFR 702.37(e)(4). In addition, at any 
time prior to the end of the comment period, the requesting 
manufacturer(s) may supplement the original request with any new 
information it receives. 40 CFR 702.37(e)(5).

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

Andrew Wheeler,
Administrator.
[FR Doc. 2020-13037 Filed 6-16-20; 8:45 am]
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