[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Notices]
[Pages 72475-72479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25743]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0132; FRL-9411-10-OCSPP]


Certain New Chemicals; Receipt and Status Information for October 
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 10/1/
2022 to 10/31/2022.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before December 27, 2022.

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 10/01/2022 to 10/31/2022. 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

[[Page 72476]]

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 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 versions of the following tables may 
adjust slightly as the Agency works to automate population of the data 
in the tables.

[[Page 72477]]



                         Table I--PMN/SNUN/MCANs Approved * From 10/1/2022 to 10/31/2022
----------------------------------------------------------------------------------------------------------------
                                   Received
       Case No.         Version      date         Manufacturer             Use             Chemical substance
----------------------------------------------------------------------------------------------------------------
J-22-0019.............        2    10/3/2022  CBI................  (G) Production of a  (G) Saccharomyces
                                                                    chemical.            cerevisiae, chromosomal
                                                                                         integration
                                                                                         modification.
J-22-0020.............        2    10/3/2022  CBI................  (G) Production of a  (G) Saccharomyces
                                                                    chemical.            cerevisiae, chromosomal
                                                                                         integration
                                                                                         modification.
J-22-0022.............        1    9/23/2022  RWDC Industries....  (G) Production of    (G) Microorganisms
                                                                    PHA.                 stably transformed to
                                                                                         manufacture PHA.
J-22-0023.............        1    9/23/2022  RWDC Industries....  (G) Production of    (G) Microorganisms
                                                                    PHA.                 stably transformed to
                                                                                         manufacture PHA.
J-22-0024.............        1    9/23/2022  RWDC Industries....  (G) Production of    (G) Microorganisms
                                                                    PHA.                 stably transformed to
                                                                                         manufacture PHA.
J-22-0025.............        1    9/23/2022  RWDC Industries....  (G) Production of    (G) Microorganisms
                                                                    PHA.                 stably transformed to
                                                                                         manufacture PHA.
P-16-0512A............        5    9/30/2022  CBI................  (S) Component of a   (G) Fatty acid dimers,
                                                                    UV curable           polymer with acrylic
                                                                    printing inks.       acid and
                                                                                         pentaerythritol
                                                                                         reaction products.
P-17-0194A............        2   10/20/2022  CBI................  (G) Pigment          (G) Hydrogenated dihalo
                                                                    additive for         dialkyl
                                                                    industrial           diindolotriphenodioxazi
                                                                    coatings.            ne,
                                                                                         dihydrodisubstituted
                                                                                         isoindolyl alkyl
                                                                                         derivs.
P-18-0070A............       11   10/24/2022  Arrowstar, LLC.....  (G) Chemical         (G) Waste plastics,
                                                                    intermediate for     polyester, depolymd.
                                                                    polyurethane         with glycols, polymers
                                                                    industry.            with dicarboxylic
                                                                                         acids.
P-20-0060A............        6    10/6/2022  CBI................  (S) Solvent-based    (G) Bismuth Carboxylate
                                                                    pigmented one- and   complexes.
                                                                    two-component
                                                                    polyurethane
                                                                    coatings
                                                                    Automotive
                                                                    Refinish General
                                                                    Industrial Coil.
P-20-0060A............        8   10/20/2022  CBI................  (S) Catalyst for     (G) Bismuth Carboxylate
                                                                    polyurethane foam    complexes.
                                                                    manufacturing.
P-22-0080A............        4    10/7/2022  Huntsman             (S) As an            (S) Poly(oxy-1,2-
                                               International LLC.   industrial           ethanediyl), ,'-
                                                                    intermediate used    (iminodi-2,1-
                                                                    in the manufacture   ethanediyl)bis[-(2-
                                                                    of polyamides as a   aminoethoxy)-;(S)
                                                                    monomer.             Poly(oxy-1,2-
                                                                                         ethanediyl), -(2-
                                                                                         aminoethyl)-(2-
                                                                                         aminoethoxy)-;.
P-22-0121A............        3    10/4/2022  CBI................  (G) Process          (G) polychloroalkene.
                                                                    Intermediate: New
                                                                    chemical substance
                                                                    will be used as a
                                                                    process
                                                                    intermediate.
P-22-0148A............        3   10/27/2022  CBI................  (G) Intermediate...  (G) Substituted
                                                                                         benzonitrile.
P-22-0153A............        3    10/6/2022  Huntsman             (S) Notified         (S) 2-Propenoic acid, 2-
                                               International LLC.   substance will be    methyl-, 2-hydroxyethyl
                                                                    used as an           ester, reaction
                                                                    adhesion promoter    products with 2-
                                                                    in a resin used      oxepanone homopolymer 2-
                                                                    for adhesive and/    [(2-methyl-1-oxo-2-
                                                                    or sealants in       propen-1-yl)oxy]ethyl]
                                                                    industrial           ester and phosphorous
                                                                    assembly or          oxide (P2O5).
                                                                    manufacturing
                                                                    operations, in
                                                                    outdoor repair.
                                                                    Through small
                                                                    scale application
                                                                    on assembly line,
                                                                    manual use, or
                                                                    automated use by
                                                                    dispensing unit.
P-22-0175.............        2   10/26/2022  Wacker Chemical      (S) Polymer Resin    (G) Modified
                                               Corporation.         Binder for           Silsesquioxane, alkoxy-
                                                                    composite stone      terminated.
                                                                    (Engineered Stone).
P-22-0187.............        2    9/29/2022  LG Energy Solution   (G) Substance for    (G) Mixed metal oxide.
                                               Michigan Inc.        use in the
                                                                    manufacture of
                                                                    battery components.
P-22-0192.............        2   10/11/2022  CBI................  (G)                  (G) Sulfonium,
                                                                    Photolithography.    tricarbocyclic-,
                                                                                         polyfluoro-heteroatom-
                                                                                         substituted
                                                                                         polycarbocyclicalkanesu
                                                                                         lfonate (1:1).
P-23-0001.............        1    10/3/2022  Solugen Inc........  (G) Additive for     (G) Polycarboxylic acid,
                                                                    consumer,            salt.
                                                                    commercial, and
                                                                    industrial
                                                                    applications.
P-23-0002.............        1    10/3/2022  Solugen Inc........  (G) Additive for     (G) Polycarboxylic acid,
                                                                    consumer,            salt.
                                                                    commercial, and
                                                                    industrial
                                                                    applications.
P-23-0003.............        1    10/3/2022  Solugen Inc........  (G) Additive for     (G) Polycarboxylic acid,
                                                                    consumer,            salt.
                                                                    commercial, and
                                                                    industrial
                                                                    applications.
P-23-0004.............        1    10/3/2022  Solugen Inc........  (G) Additive for     (G) Polycarboxylic acid,
                                                                    consumer,            salt.
                                                                    commercial, and
                                                                    industrial
                                                                    applications.
P-23-0005.............        1    10/3/2022  Solugen Inc........  (G) Additive for     (G) Polycarboxylic acid,
                                                                    consumer,            salt.
                                                                    commercial, and
                                                                    industrial
                                                                    applications.
P-23-0006.............        2   10/13/2022  Siltech Inc........  (G) additive.......  (S) Siloxanes and
                                                                                         silicones, di-Me, Me
                                                                                         hydrogen, reaction
                                                                                         products with vinyl
                                                                                         group-terminated di-Me
                                                                                         siloxanes.
P-23-0009.............        1    10/5/2022  Givaudan Fragrances  (G) Fragrance        (G) Cysteine, cyclic
                                               Corp.                ingredient for use   alkyl, ethyl ester.
                                                                    in laundry
                                                                    applications.
P-23-0010.............        1    10/5/2022  Givaudan Fragrances  (G) Fragrance        (G) Alkylthio ketone.
                                               Corp.                ingredient for use
                                                                    in laundry
                                                                    applications.
P-23-0011.............        1   10/10/2022  CBI................  (G) Cross-linking    (G)
                                                                    agent.               divinylperfluoroalkane.
P-23-0012.............        1   10/11/2022  CBI................  (S) Polymer for use  (G) Starch, polymer with
                                                                    in concrete          alkenoic acid, salt.
                                                                    applications.
P-23-0013.............        1   10/12/2022  Honeycomb Techno     (S) Epoxy molding    (S) Phenol, polymer with
                                               Research USA Inc.    compound for         4,4'-bis(chloromethyl)-
                                                                    electronic device.   1,1'-biphenyl.
P-23-0015.............        1   10/26/2022  CBI................  (G) Water treatment  (G) Amines,
                                                                    chemical.            polyalkylenepoly,
                                                                                         (disubstitutedcarboxy)
                                                                                         derivs., alkali metal
                                                                                         salts.
P-23-0016.............        1   10/26/2022  Kuraray America,     (G) Additive for     (S) 2-Propanol, 1,3-
                                               Inc.                 paints, UV inks,     bis[(3-methyl-2-buten-1-
                                                                    coatings, etc.       yl)oxy]-.
SN-21-0003A...........        4   10/26/2022  Norquay Technology   (G) Intermediate...  (S) 1,1'-Biphenyl, 4,4'-
                                               Inc.                                      dibromo-.
----------------------------------------------------------------------------------------------------------------
* 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 prior to the start of the 90 day review
  period, and in no way reflects the final status of a complete submission review.


[[Page 72478]]

    In Table II. of this unit, EPA provides the following information 
(to the extent that such information is not subject to a CBI claim) on 
the TMEs and/or Biotech Exemptions received by EPA during this period: 
The EPA case number assigned to the TME and/or Biotech Exemption, the 
submission document type (initial or amended), the version number, the 
date the TME and/or Biotech Exemption was received by EPA, the 
submitting manufacturer (i.e., domestic producer or importer), the 
potential uses identified by the manufacturer in the TME and/or Biotech 
Exemption, and the chemical substance identity.

                                       Table II--TMEs and Biotech Exemptions Received From 10/1/2022 to 10/31/2022
--------------------------------------------------------------------------------------------------------------------------------------------------------
        Case No.            Submission type         Version      Received date        Manufacturer                Use              Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
T-22-0001A.............  Test Marketing                      3       10/4/2022  CBI....................  (G) Functional        (G) Mica-group minerals,
                          Exemption                                                                       mineral in            reaction products with
                          Application (TMEA).                                                             automotive            triethoxysilyl
                                                                                                          components, and       substituted-alkane.
                                                                                                          mineral for
                                                                                                          plastics.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In Table III 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 III--NOCs Approved * From 10/1/2022 to 10/31/2022
----------------------------------------------------------------------------------------------------------------
                                                               If amendment, type of
         Case No.           Received date  Commencement date         amendment            Chemical substance
----------------------------------------------------------------------------------------------------------------
P-12-0346................      10/20/2022         10/17/2022  N.....................  (S) 2-propanone, 2,2',2``-
                                                                                       [o,o',o''-
                                                                                       (ethylsilylidyne)trioxime
                                                                                       ].
P-15-0691A...............       10/7/2022          7/22/2022  Amended generic         (G) Polyamidoamine n-
                                                               chemical name.          carbodithioate, sodium
                                                                                       salt.
P-18-0282A...............      10/25/2022          10/6/2021  Amended generic         (G) Fatty acid ester,
                                                               chemical name.          polyether,
                                                                                       poly[di(ethylene glycol)
                                                                                       adipate], methylene
                                                                                       diphenyl diisocyanate.
P-21-0023................       10/5/2022           9/7/2022  N.....................  (G) Sulfonium, carbocyclic-
                                                                                       , salt with 1-(alkyl) 2-
                                                                                       [4-[polyhydro-2-
                                                                                       carbomonocyclic-5-
                                                                                       (polyfluoro-2-sulfoalkyl)-
                                                                                       4,7-methano-1,3-
                                                                                       benzodioxol-2-
                                                                                       yl]carbomonocyclic
                                                                                       oxy]acetate (1:1).
P-21-0068................       10/6/2022           9/8/2022  N.....................  (G) Metalloxanes, alkyl,
                                                                                       alkyl group-terminated,
                                                                                       reaction products with
                                                                                       dihalo-dialkylalkylaryl-
                                                                                       alkyl-polycyclic-
                                                                                       ylidene(dialkylsilylene)-
                                                                                       dialkylalkylarylalkylalky
                                                                                       l-polycyclic-ylidene,
                                                                                       metal oxide and
                                                                                       nonmetallic oxide.
P-21-0085................      10/11/2022          9/15/2022  N.....................  (S) 1-propanethiol, 3-
                                                                                       (triethoxysilyl)-,
                                                                                       reaction products with
                                                                                       polybutadiene.
----------------------------------------------------------------------------------------------------------------
* 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 IV 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 IV--Test Information Received From 10/1/2022 to 10/31/2022
----------------------------------------------------------------------------------------------------------------
                Case No.                   Received date   Type of test information       Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0543...............................      10/14/2022  Industrial Hygiene          (G) Halogenophosphoric
                                                           Exposure Report.            acid metal salt.
P-21-0011...............................      10/14/2022  Test Scheduling             (G) Hexane, 1,6-
                                                           Notification.               diisocyanato-,
                                                                                       homopolymer, alkyl epoxy
                                                                                       ether- and polyethylene
                                                                                       glycol mono-me ether-
                                                                                       blocked, reaction
                                                                                       products with
                                                                                       propylenimine.
----------------------------------------------------------------------------------------------------------------


[[Page 72479]]

    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: November 21, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2022-25743 Filed 11-23-22; 8:45 am]
BILLING CODE 6560-50-P


