[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77593-77596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27448]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0132; FRL-9411-11-OCSPP]


Certain New Chemicals; Receipt and Status Information for 
November 2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA), 
as amended by the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act, to make information publicly available and to publish 
information in the Federal Register pertaining to submissions under 
TSCA Section 5, including notice of receipt of a Premanufacture notice 
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial 
Activity Notice (MCAN), including an amended notice or test 
information; an exemption application (Biotech exemption); an 
application for a test marketing exemption (TME), both pending and/or 
concluded; a notice of commencement (NOC) of manufacture (including 
import) for new chemical substances; and a periodic status report on 
new chemical substances that are currently under EPA review or have 
recently concluded review. This document covers the period from 11/1/
2022 to 11/30/2022.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before January 18, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2022-0132, 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. Additional 
instructions on commenting and visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Jim Rahai, Project Management 
and Operations Division (MC 7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-8593; 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. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the 
period from 11/01/2022 to 11/30/2022. 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 EPA's 
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a 
weekly basis.

B. What is the Agency's 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 EPA's 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 3(11).) For more 
information about the 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 5(a)(3).
    TSCA section 5(h)(1) 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 5(a)(2), 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: https://www.epa.gov/chemicals-under-tsca.
    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 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 as CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a

[[Page 77594]]

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/commenting-epa-dockets.

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) (FRL-4942-7). 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 EPA's 
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-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 
initial submission, or an amendment, a notation of which version was 
received, the date the notice was received by EPA, the submitting 
manufacturer (i.e., domestic producer or importer), the potential uses 
identified by the manufacturer in the notice, and the chemical 
substance identity.
    As used in each of the tables in this unit, (S) indicates that the 
information in the table is the specific information provided by the 
submitter, and (G) indicates that this information in the table is 
generic information because the specific information provided by the 
submitter was claimed as CBI. Submissions which are initial submissions 
will not have a letter following the case number. Submissions which are 
amendments to previous submissions will have a case number followed by 
the letter ``A'' (e.g. P-18-1234A). The version column designates 
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some 
cases, an initial submission is not numbered as version 1; this is 
because earlier version(s) were rejected as incomplete or invalid 
submissions. Note also that future version of the following tables may 
adjust slightly as the Agency works to automate population of the data 
in the tables.

                         Table I--PMN/SNUN/MCANs Approved * From 11/1/2022 to 11/30/2022
----------------------------------------------------------------------------------------------------------------
                                        Received
        Case No.           Version        date         Manufacturer             Use           Chemical substance
----------------------------------------------------------------------------------------------------------------
J-23-0002..............            1   10/07/2022  CBI................  (G) Manufacture of   (G) Microorganism
                                                                         a recombinant        stably transformed
                                                                         protein.             to express a
                                                                                              recombinant
                                                                                              protein.
P-20-0060A.............            9   11/05/2022  CBI................  (S) Catalyst for     (G) Bismuth
                                                                         polyurethane foam    Carboxylate
                                                                         manufacturing.       complexes.
P-22-0019A.............            2   11/23/2022  CBI................  (G) Film-forming     (G) Protein sodium
                                                                         polymer.             complexes,
                                                                                              polymers with
                                                                                              aromatic acid
                                                                                              chloride, ethylene
                                                                                              diamine and amino
                                                                                              acid.
P-22-0044A.............            3   11/22/2022  CBI................  (G) Site Limited     (G) Silica gel,
                                                                         Intermediate.        reaction products
                                                                                              with alkyl metal
                                                                                              salt.
P-22-0107A.............            3   11/29/2022  Locus Fermentation   (G) Surfactant for   (G) Glycolipids,
                                                    Solutions.           consumer,            sophorose-contg.,
                                                                         industrial,          yeast-fermented,
                                                                         commercial           from glycerides
                                                                         applications.        and carbohydrates,
                                                                                              salts.
P-22-0108A.............            3   11/29/2022  Locus Fermentation   (G) Surfactant for   (G) Glycolipids,
                                                    Solutions.           consumer,            sophorose-contg.,
                                                                         industrial,          yeast-fermented,
                                                                         commercial           from glycerides
                                                                         applications.        and carbohydrates,
                                                                                              salts.
P-22-0109A.............            3   11/29/2022  Locus Fermentation   (G) Surfactant for   (G) Glycolipids,
                                                    Solutions.           consumer,            sophorose-contg.,
                                                                         industrial,          yeast-fermented,
                                                                         commercial           from glycerides
                                                                         applications.        and carbohydrates,
                                                                                              salts.
P-22-0110A.............            3   11/29/2022  Locus Fermentation   (G) Surfactant for   (G) Glycolipids,
                                                    Solutions.           consumer,            sophorose-contg.,
                                                                         industrial,          yeast-fermented,
                                                                         commercial           from glycerides
                                                                         applications.        and carbohydrates,
                                                                                              salts.
P-22-0111A.............            3   11/29/2022  Locus Fermentation   (G) Surfactant for   (G) Glycolipids,
                                                    Solutions.           consumer,            sophorose-contg.,
                                                                         industrial,          yeast-fermented,
                                                                         commercial           from glycerides
                                                                         applications.        and carbohydrates,
                                                                                              salts.
P-22-0112A.............            3   11/29/2022  Locus Fermentation   (G) Surfactant for   (G) Glycolipids,
                                                    Solutions.           consumer,            sophorose-contg.,
                                                                         industrial,          yeast-fermented,
                                                                         commercial           from glycerides
                                                                         applications.        and carbohydrates,
                                                                                              salts.
P-23-0006A.............            3   11/04/2022  Siltech, Inc.......  (G) Additive.......  (S) Siloxanes and
                                                                                              silicones, di-Me,
                                                                                              Me hydrogen,
                                                                                              polymers with
                                                                                              vinyl group-
                                                                                              terminated di-Me
                                                                                              siloxanes.
P-23-0014..............            4   11/21/2022  CBI................  (S) Intermediate in  (G) [Polyalkyl-
                                                                         production of        methylenepolyhydro-
                                                                         fragrance.           polycyclic]alkyl
                                                                                              acetate.
P-23-0017..............            2   11/07/2022  Givaudan Fragrances  (S) Encapsulant for  (G) Hydrolyzed
                                                    Corp.                time-released        collagen, polymer
                                                                         delivery of          with aromatic
                                                                         fragrance.           isocyanate, N-
                                                                                              triethoxysylil-
                                                                                              alkanamine, pectic
                                                                                              polysaccharide and
                                                                                              poly alkyl
                                                                                              alcohol.
P-23-0018..............            2   11/02/2022  H.B. Fuller Company  (S) Industrial       (G) Vegetable oil,
                                                                         Adhesive.            polymer with
                                                                                              pimelin ketone,
                                                                                              oxymethylene and
                                                                                              polymethylenepolyp
                                                                                              henylene
                                                                                              isocyanate.

[[Page 77595]]

 
P-23-0018A.............            3   11/14/2022  H.B. Fuller Company  (S) Industrial       (G) Vegetable oil,
                                                                         Adhesive.            polymer with
                                                                                              pimelin ketone,
                                                                                              oxymethylene and
                                                                                              polymethylenepolyp
                                                                                              henylene
                                                                                              isocyanate.
P-23-0019..............            2   11/04/2022  CBI................  (G)                  (G) Sulfonium,
                                                                         Photolithography.    triphenyl-,
                                                                                              polyhydro-5-
                                                                                              (polyfluoro-2-
                                                                                              sulfoalkyl)spiro[4
                                                                                              ,7-methano-1,3-
                                                                                              benzodioxole-2,2'-
                                                                                              polycycloalkane]-5-
                                                                                              carboxylate (1:1).
P-23-0020..............            1   11/04/2022  Siltech, Inc.......  (G) Additive/        (S)
                                                                         intermediate.        Silsesquioxanes, 3-
                                                                                              mercaptopropyl,
                                                                                              polymers with
                                                                                              silic acid
                                                                                              (H4SiO4) tetra-Et
                                                                                              ester,
                                                                                              [(trimethylsilyl)o
                                                                                              xy]-terminated.
P-23-0021..............            2   11/16/2022  CBI................  (G) Resin used for   (G) Ethylene,
                                                                         the fabrication of   polymer with
                                                                         articles.            tetrafluoroethylen
                                                                                              e and
                                                                                              hexafluoropropene.
P-23-0022..............            1   11/11/2022  Cabot Corporation..  (G) Additive used    (G) Multi-walled
                                                                         in industrial        carbon nanotubes.
                                                                         applications.
P-23-0023..............            1   11/11/2022  Cabot Corporation..  (G) Additive used    (G) Multi-walled
                                                                         in industrial        carbon nanotubes.
                                                                         applications..
P-23-0024..............            1   11/11/2022  Cabot Corporation..  (G) Additive used    (G) Multi-walled
                                                                         in industrial        carbon nanotubes.
                                                                         applications..
P-23-0025..............            1   11/11/2022  Solugen, Inc.......  (G) Additive used    (G) Polycarboxylic
                                                                         in consumer,         acid, salt.
                                                                         industrial, and
                                                                         commercial
                                                                         applications.
P-23-0026..............            1   11/11/2022  Solugen, Inc.......  (G) Additive used    (G) Polycarboxylic
                                                                         in consumer,         acid, salt.
                                                                         industrial, and
                                                                         commercial
                                                                         applications.
P-23-0027..............            1   11/11/2022  Solugen, Inc.......  (G) Additive used    (G) Polycarboxylic
                                                                         in consumer,         acid, salt.
                                                                         industrial, and
                                                                         commercial
                                                                         applications.
P-23-0029..............            1   11/14/2022  CBI................  (G) Battery Cathode  (G) Cobalt metal
                                                                         Manufacturing.       nickel oxide.
P-23-0030..............            1   11/17/2022  CBI................  (G) A polymer of     (G) Phenol,
                                                                         insulating           polyalkylcarbo bis-
                                                                         materials.           , polymer with 2-
                                                                                              carbomonocyclichal
                                                                                              oheteromonocycle,
                                                                                              bis[(alkenylcarbom
                                                                                              onocyclic)alkyl]
                                                                                              ether.
P-23-0031..............            1   11/21/2022  Tetramer             (G) Component in     (G) Glycerin,
                                                    Technologies, LLC.   Lubricants.          polyalkoxylated,
                                                                                              mixed fatty acid
                                                                                              and alkyl diacid
                                                                                              esters.
P-23-0032..............            2   11/28/2022  ADC--Adrian........  (S) Industrial       (S) 1,3
                                                                         belting--Tough       propanediol,
                                                                         material with very   polymer with 1,3
                                                                         good flex fatigue    diisocyanatomethyl
                                                                         properties to        benzene.
                                                                         replace current
                                                                         products.
                                                                        No crush wheels--
                                                                         used in multiple
                                                                         industries; the
                                                                         good flex fatigue
                                                                         properties,
                                                                         resilience, and
                                                                         toughness would
                                                                         make an ideal
                                                                         polymer for this
                                                                         application.
                                                                        General replacement
                                                                         for
                                                                         polytetramethylene
                                                                         ether glycol
                                                                         (PTMEG)-based cast
                                                                         urethane parts
                                                                         fatigue properties.
P-23-0033..............            1   11/22/2022  Cabot Corporation..  (G) Additive used    (G) Multi-walled
                                                                         in industrial        carbon nanotubes.
                                                                         applications.
P-23-0034..............            1   11/23/2022  CBI................  (G) Process aid....  (G) Derivative of a
                                                                                              diallyldimethylamm
                                                                                              onium chloride and
                                                                                              substituted
                                                                                              ethylene
                                                                                              copolymer.
SN-22-0007A............            4   11/11/2022  Braven               (G) Product of       (S) Waste plastics,
                                                    Environmental, LLC.  Pyrolysis            pyrolyzed, C5-12
                                                                         manufacturing.       fraction.
SN-22-0008A............            4   11/11/2022  Braven               (G) Product of       (S) Waste plastics,
                                                    Environmental, LLC.  Pyrolysis            pyrolyzed, C20-55
                                                                         Manufacturing.       fraction.
SN-22-0009A............            4   11/11/2022  Braven               (G) Product of       (S) Waste plastics,
                                                    Environmental, LLC.  Pyrolysis            pyrolyzed, C9-20
                                                                         Manufacturing.       fraction.
SN-23-0001.............            2   11/03/2022  Ultium Cells, LLC..  (S) Use as a         (G) Single-walled
                                                                         conductive           carbon nanotubes.
                                                                         material in
                                                                         battery cells.
----------------------------------------------------------------------------------------------------------------

    In Table II of this unit, EPA provides the following information 
(to the extent that such information is not claimed as CBI) on the NOCs 
that have passed an initial screening by EPA during this period: The 
EPA case number assigned to the NOC including whether the submission 
was an initial or amended submission, the date the NOC was received by 
EPA, the date of commencement provided by the submitter in the NOC, a 
notation of the type of amendment (e.g., amendment to generic name, 
specific name, technical contact information, etc.) and chemical 
substance identity.

                             Table II--NOCs Approved * From 11/1/2022 to 11/30/2022
----------------------------------------------------------------------------------------------------------------
                                               Commencement    If amendment, type of
          Case No.            Received date        date              amendment            Chemical substance
----------------------------------------------------------------------------------------------------------------
P-17-0306A.................      11/22/2022        09/11/2022  Amended generic        (G) Vegetable oil, polymer
                                                                chemical name.         with alkyl dialcohol,
                                                                                       cyclic dicarboxylic
                                                                                       anhydride, aromatic
                                                                                       dicarboxylic acid, and
                                                                                       polyglycol.

[[Page 77596]]

 
P-18-0362..................      11/03/2022        10/20/2022  N....................  (S) 1,3-propanediol, 2-
                                                                                       ethyl-2-(hydroxymethyl)-,
                                                                                       polymer with 2, 4-
                                                                                       diisocyanato-1-
                                                                                       methylbenzene, alpha-
                                                                                       hydro-omega-
                                                                                       hydroxypoly[oxy(methyl-
                                                                                       1,2-ethanediyl)] and
                                                                                       alpha, alpha prime, alpha
                                                                                       double prime-1,2, 3-
                                                                                       propanetriyltris[omega-
                                                                                       hydroxypoly[oxy(methyl-
                                                                                       1,3-ethandiyl)]], me et
                                                                                       ketone oxime blocked.
P-19-0019A.................      11/16/2022        08/21/2021  Amended generic        (G) Chlorofluoroalkane.
                                                                chemical name.
P-19-0108..................      11/11/2022        11/11/2022  N....................  (S) Benzoic acid, 2-chloro-
                                                                                       4-methyl-, ethyl ester.
P-19-0187..................      11/11/2022        11/11/2022  N....................  (S) Benzoic acid, 2-chloro-
                                                                                       4-methyl-, sodium salt
                                                                                       (1:1).
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission.

    In Table III of this unit, EPA provides the following information 
(to the extent such information is not subject to a CBI claim) on the 
test information that has been received during this time period: The 
EPA case number assigned to the test information; the date the test 
information was received by EPA, the type of test information 
submitted, and chemical substance identity.

                        Table III--Test Information Received From 11/1/2022 to 11/30/2022
----------------------------------------------------------------------------------------------------------------
             Case No.               Received date      Type of test information           Chemical substance
----------------------------------------------------------------------------------------------------------------
P-13-0021........................      11/15/2022  Test Data Validation Study......  (G) Perfluoroacrylate
                                                                                      polymer.
P-16-0543........................      11/28/2022  Exposure Monitoring Report......  (G) Halogenophosphoric acid
                                                                                      metal salt.
P-16-0543........................      11/14/2022  Exposure Monitoring Report......  (G) Halogenophosphoric acid
                                                                                      metal salt.
----------------------------------------------------------------------------------------------------------------

    If you are interested in information that is not included in these 
tables, you may contact EPA's technical information contact or general 
information contact as described under FOR FURTHER INFORMATION CONTACT 
to access additional non-CBI information that may be available.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: December 13, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2022-27448 Filed 12-16-22; 8:45 am]
BILLING CODE 6560-50-P


