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Federal Register / Vol. 86, No. 26 / Wednesday, February 10, 2021 / Notices along with more information about dockets generally, is available at http
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Jim Rahai, Project Management and Operations Division 7407M, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
204600001; telephone number: 202
5648593; email address: rahai.jim@
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. Executive Summary What action is the Agency taking?
This document provides the receipt and status reports for the period from 12/01/2020 to 12/31/2020. The Agency is providing notice of receipt of PMNs, SNUNs and MCANs including amended notices and test information;
an exemption application under 40 CFR
part 725 Biotech exemption; TMEs, both pending and/or concluded; NOCs to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review.
EPA is also providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPAs determination for PMN/SNUN/
MCAN notices on its website at: https
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/
status-pre-manufacture-notices. This information is updated on a weekly basis.
B. What is the Agencys authority for taking this action?
Under the Toxic Substances Control Act TSCA, 15 U.S.C. 2601 et seq., a chemical substance may be either an existing chemical substance or a new chemical substance. Any chemical substance that is not on EPAs TSCA Inventory of Chemical Substances TSCA Inventory is classified as a new chemical substance, while a chemical substance that is listed on the TSCA
Inventory is classified as an existing chemical substance. See TSCA section 311. For more information about the
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TSCA Inventory please go to: https
www.epa.gov/tsca-inventory.
Any person who intends to manufacture including import a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA
has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the chemical substance or significant new use, and take appropriate action as described in TSCA section 5a3.
TSCA section 5h1 authorizes EPA
to allow persons, upon application and under appropriate restrictions, to manufacture or process a new chemical substance, or a chemical substance subject to a significant new use rule SNUR issued under TSCA section 5a2, for test marketing purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical will not present an unreasonable risk of injury to health or the environment.
This is referred to as a test marketing exemption, or TME. For more information about the requirements applicable to a new chemical go to:
http www.epa.gov/oppt/newchems.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to publish in the Federal Register certain information, including notice of receipt of a PMN/SNUN/MCAN including amended notices and test information;
an exemption application under 40 CFR
part 725 biotech exemption; an application for a TME, both pending and concluded; NOCs to manufacture a new chemical substance; and a periodic status report on the new chemical substances that are currently under EPA
review or have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in general.
D. Does this action have any incremental economic impacts or paperwork burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information 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 CDROM that
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you mail to EPA, mark the outside of the disk or CDROM as CBI and then identify electronically within the disk or CDROM the specific information that is claimed as 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. Status Reports In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the Federal Register after providing notice of such changes to the public and an opportunity to comment See the Federal Register of May 12, 1995, 60
FR 25798 FRL49427. Since the passage of the Lautenberg amendments to TSCA in 2016, public interest in information on the status of section 5
cases under EPA review and, in particular, the final determination of such cases, has increased. In an effort to be responsive to the regulated community, the users of this information, and the general public, to comply with the requirements of TSCA, to conserve EPA resources and to streamline the process and make it more timely, EPA is providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPAs determination for PMN/SNUN/
MCAN notices on its website at: https
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/
status-pre-manufacture-notices. This information is updated on a weekly basis.
III. Receipt Reports For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information to the extent that such information is not subject to a CBI
claim on the notices screened by EPA
during this period: The EPA case number assigned to the notice that indicates whether the submission is an
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