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, 10267-10269 [2021-03383]

Download as PDF Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OAR–2020–0351; FRL–10020–42– OAR] Ozone Transport Commission Recommendation That EPA Require Daily Limits for Emissions of Nitrogen Oxides From Certain Sources in Pennsylvania: Extension of Comment Period Environmental Protection Agency (EPA). ACTION: Notice; extension of comment period. AGENCY: On January 15, 2021, EPA issued a Federal Register notice of public hearing and supplemental information regarding a recommendation submitted by the Ozone Transport Commission (OTC) to address ongoing ozone pollution in the northeastern United States. The OTC has recommended that EPA require Pennsylvania to revise its state implementation plan (SIP) to include additional control measures that would establish daily limits on emissions of nitrogen oxides (NOX) from coal-fired electricity generating units (EGUs) with already-installed selective catalytic reduction (SCR) or selective noncatalytic reduction (SNCR) controls. This document extends the comment period for 30 days, from March 8, 2021 to April 7, 2021. DATES: Comments identified by docket identification (ID) number EPA–HQ– OAR–2020–0351 must be received on or before April 7, 2021. ADDRESSES: Follow the detailed instructions provided under ADDRESSES in the Federal Register document of January 15, 2021 (86 FR 4049). FOR FURTHER INFORMATION CONTACT: Beth Murray, Clean Air Markets Division, Office of Atmospheric Programs, Office of Air and Radiation, Environmental Protection Agency, 202–343–9115, murray.beth@epa.gov. SUPPLEMENTARY INFORMATION: This document extends the public comment period established in the Federal Register document of January 15, 2021 (86 FR 4049), which opened a public comment period for supplemental information concerning a recommendation submitted by the OTC to EPA under CAA section 184(c). In the January 15, 2021 notice, EPA discussed the relevant statutory provisions, described the steps EPA is following to facilitate public participation in the Agency’s process for reaching a decision on the recommendation, discussed the OTC recommendation—including the tkelley on DSKBCP9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:07 Feb 18, 2021 Jkt 253001 Delaware, Maryland, and New Jersey rules that OTC believes should become the standards for EPA’s approval of a responsive SIP revision from Pennsylvania, identified the potentially affected Pennsylvania EGUs, and summarized the supporting information provided by the OTC. EPA further provided information on the potentially affected EGUs’ historical emissions and on regulatory context that may be relevant to EPA’s decision on the recommendation. EPA is hereby extending the public comment period, which was set to end on March 8, 2021, to April 7, 2021. After considering a request to extend the comment period received from a stakeholder, EPA is extending the comment period for the following reasons: (1) The legal and technical complexity of the analysis of the recommendation; (2) the need for stakeholders to consider the interaction of this decision with other actions the Agency is concurrently considering; (3) the stakeholders’ need for additional time to review and develop constructive comments and related analyses on the recommendation. To submit comments, or access the docket, please follow the detailed instructions provided under ADDRESSES in the Federal Register document of January 15, 2021. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. Hans Christopher Grundler, Director, Office of Atmospheric Programs. [FR Doc. 2021–03367 Filed 2–18–21; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2020–0738; FRL–10019– 82] 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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 SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 10267 ethanone, 1-(1,2,3,4,5,6,7,8-octahydro2,3,5,5-tetramethyl-2-naphthalenyl), ethanone, 1-(1,2,3,4,5,6,7,8-octahydro2,3,8,8-tetramethyl-2-naphthalenyl), ethanone, 1-(1,2,3,4,6,7,8,8a-octahydro2,3,8,8-tetramethyl-2-naphthalenyl), and ethanone, 1-(1,2,3,5,6,7,8,8a-octahydro2,3,8,8-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 https://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 https:// www.epa.gov/dockets/contacts.html. Please note that due to the public health emergency the EPA Docket Center (EPA/DC) and Reading Room E:\FR\FM\19FEN1.SGM 19FEN1 10268 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 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 tkelley on DSKBCP9HB2PROD with NOTICES 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-chemicalsunder-tsca/risk-evaluations-existingchemicals-under-tsca. TSCA section 6(b) also allows manufacturers of a chemical substance to request an EPA-conducted risk evaluation on the chemical substance. VerDate Sep<11>2014 21:07 Feb 18, 2021 Jkt 253001 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): D The circumstances identified in the request constitute conditions of use that warrant inclusion in a risk evaluation for the chemical substance; D EPA has all the information needed to conduct such risk evaluation on the conditions of use that were the subject of the request; and PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 D 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 https://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- E:\FR\FM\19FEN1.SGM 19FEN1 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 2,3,5,5-tetramethyl-2-naphthalenyl), ethanone, 1-(1,2,3,4,5,6,7,8-octahydro2,3,8,8-tetramethyl-2-naphthalenyl), ethanone, 1-(1,2,3,4,6,7,8,8a-octahydro2,3,8,8-tetramethyl-2-naphthalenyl), and ethanone, 1-(1,2,3,5,6,7,8,8a-octahydro2,3,8,8-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. 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. tkelley on DSKBCP9HB2PROD with NOTICES 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). 21:07 Feb 18, 2021 Jkt 253001 Jane Nishida, Acting Administrator. [FR Doc. 2021–03383 Filed 2–18–21; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OW–2019–0372; FRL–10019–29– OW] National Pollutant Discharge Elimination System (NPDES) 2021 Issuance of the Multi-Sector General Permit for Stormwater Discharges Associated With Industrial Activity Environmental Protection Agency (EPA). ACTION: Notice of final permit issuance. AGENCY: All 10 of the Environmental Protection Agency’s (EPA) Regions are finalizing the 2021 National Pollutant Discharge Elimination System (NPDES) general permit for stormwater discharges associated with industrial activity, also referred to as the ‘‘2021 Multi-Sector General Permit (MSGP)’’ or the ‘‘final permit.’’ This final permit replaces EPA’s administratively continued 2015 MSGP that expired on June 3, 2020. EPA is issuing this permit for five (5) years to provide permit coverage to eligible operators in all areas of the country where EPA is the NPDES permitting authority, including Idaho (until July 1, 2021), Massachusetts, New Hampshire, New Mexico, Indian country lands, Puerto Rico, the District of Columbia, and most U.S. territories and protectorates. This Federal Register document summarizes the final permit. EPA encourages the public to read the final permit and accompanying fact sheet to better understand the final permit. The final permit and fact sheet can be found at https://www.epa.gov/ npdes/stormwater-dischargesindustrial-activities. DATES: The final permit becomes effective on March 1, 2021. This effective date is necessary to provide dischargers with the immediate opportunity to comply with Clean Water Act (CWA) requirements in light of the expiration of the 2015 MSGP on June 3, 2020. In accordance with 40 CFR part 23, the 2021 MSGP shall be considered issued for the purpose of judicial review on March 5, 2021. Under CWA section 509(b), judicial review of this general permit can be requested by filing a petition for review in the United States Court of Appeals within 120 days after the permit is issued. Under CWA section 509(b)(2), the requirements in SUMMARY: B. What are the conditions of use? VerDate Sep<11>2014 Authority: 15 U.S.C. 2601 et seq. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 10269 this permit may not be challenged later in civil or criminal proceedings to enforce these requirements. In addition, this permit may not be challenged in other agency proceedings. Deadlines for submittal of a Notice of Intent (NOI) are provided in Part 1.3 of the 2021 MSGP. The 2021 MSGP also provides additional dates for compliance with the terms of the permit. FOR FURTHER INFORMATION CONTACT: For further information on the final permit, contact the appropriate EPA Regional office listed in Section I.F of this document, or Emily Halter, EPA Headquarters, Office of Water, Office of Wastewater Management (4203M), 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: 202–564– 3324; email address: halter.emily@ epa.gov. SUPPLEMENTARY INFORMATION: This section is organized as follows: Table of Contents I. General Information A. Does this action apply to me? B. How can I get copies of these documents and other related information? C. Who are the EPA regional contacts for the final permit? II. Background of the Industrial Stormwater Program III. Summary of the 2021 MSGP A. 2015 MSGP Litigation and National Academies Study B. Summary of Significant Final Permit Changes From the 2015 MSGP C. Summary of Changes From Proposed 2020 MSGP IV. Implementation Assistance V. Paperwork Reduction Act (PRA) VI. 2021 MSGP Incremental Cost Analysis and Future Cost-Benefit Considerations VII. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review VIII. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations IX. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments X. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use I. General Information A. Does this action apply to me? The final permit covers stormwater discharges to waters of the United States from industrial facilities in the 30 sectors shown below: Sector A—Timber Products. Sector B—Paper and Allied Products Manufacturing. Sector C—Chemical and Allied Products Manufacturing. E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[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.

-----------------------------------------------------------------------

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 https://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 https://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: 
[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 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 https://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]
BILLING CODE 6560-50-P
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