Document ID: EPA-HQ-OPPT-2020-0738-0001
Agency: epa
Document Type: Notice
Title: Chemical Category for OctahydroTetramethyl-Naphthalenyl-Ethanone (OTNE); Manufacturer Request for Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comments
Posted Date: 2021-02-19T05:00Z

[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Pages 10267-10269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03383]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2020-0738; FRL-10019-82]

Chemical Category for Octahydro-Tetramethyl-Naphthalenyl-Ethanone 
(OTNE); 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: The Environmental Protection Agency (EPA) is announcing the 
availability of and soliciting public comment on a manufacturer request 
for a risk evaluation under the Toxic Substances Control Act (TSCA) of 
ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-
naphthalenyl), ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-
tetramethyl-2-naphthalenyl), ethanone, 1-(1,2,3,4,6,7,8,8a-octahydro-
2,3,8,8-tetramethyl-2-naphthalenyl), and ethanone, 1-(1,2,3,5,6,7,8,8a-
octahydro-2,3,8,8-tetramethyl-2-naphthalenyl) (collectively, ``OTNE''). 
The request was made by International Flavors and Fragrances, Inc. 
(IFF), Privi Organics USA Corporation (Privi), and DRT America, Inc. 
(DRT) through the OTNE Consortium. 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 OTNE. EPA specifically invites public comment on the 
inclusion of any additional conditions of use and potentially exposed 
or susceptible subpopulations. The Agency is in the process of broadly 
re-examining how it intends to implement these and other provisions of 
amended TSCA including determining how new executive orders and other 
direction provided by the Biden-Harris Administration will be 
addressed. This process would benefit greatly from stakeholder 
feedback. 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 April 5, 2021.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0738, through 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. 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

[[Page 10268]]

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: 
Jeffrey Putt, Existing Chemicals Risk Management Division (Mail Code 
7404T), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-3703; email address: 
putt.jeffrey@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 OTNE. 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 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 at 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):
    [ssquf] The circumstances identified in the request constitute 
conditions of use that warrant inclusion in a risk evaluation for the 
chemical substance;
    [ssquf] EPA has all the information needed to conduct such risk 
evaluation on the conditions of use that were the subject of the 
request; and
    [ssquf] 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 OTNE 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 OTNE. 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 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 November 20, 2020, EPA received a complete manufacturer request 
for a TSCA risk evaluation of OTNE that was made by IFF, Privi, and 
DRT, through the OTNE Consortium. 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 December 8, 2020 
via a listserv announcement to stakeholders.

A. What is OTNE?

    OTNE is used as a fragrance ingredient. The four chemical 
substances in this chemical category are listed on the TSCA Inventory 
as: Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-

[[Page 10269]]

2,3,5,5-tetramethyl-2-naphthalenyl), ethanone, 1-(1,2,3,4,5,6,7,8-
octahydro-2,3,8,8-tetramethyl-2-naphthalenyl), ethanone, 1-
(1,2,3,4,6,7,8,8a-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl), and 
ethanone, 1-(1,2,3,5,6,7,8,8a-octahydro-2,3,8,8-tetramethyl-2-
naphthalenyl). The associated Chemical Abstracts Service Registry 
Numbers (CASRNs) are 54464-59-4, 54464-57-2, 68155-67-9, and 68155-66-
8, respectively. TSCA section 26(c) provides for EPA to take action on 
a category of chemical substances whenever authorized or required by 
TSCA to take action on a chemical substance. 15 U.S.C. 2625(c). EPA is 
treating these four CASRNs (54464-59-4, 54464-57-2, 68155-67-9, and 
68155-66-8) as a category of chemical substances for purposes of this 
manufacturer-requested risk evaluation.

B. What are the conditions of use?

    The manufacturer request for a risk evaluation of OTNE identifying 
conditions of use of interest to the manufacturer is included in docket 
EPA-HQ-OPPT-2020-0738. Subject to further analysis and public comment, 
EPA anticipates including activities identified in the request as 
conditions of use in the risk evaluation of OTNE.
    EPA has identified additional conditions of use pursuant to 40 CFR 
702.37(e)(3), which are also included in docket EPA-HQ-OPPT-2020-0738.

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 
substances 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.

Jane Nishida,
Acting Administrator.
[FR Doc. 2021-03383 Filed 2-18-21; 8:45 am]
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