[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,
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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: [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 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
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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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