Document ID: EPA-HQ-OPPT-2023-0061-0024
Agency: epa
Document Type: Notice
Title: Certain New Chemicals: Receipt and Status Information for September 2023
Posted Date: 2023-10-24T04:00Z

[Federal Register Volume 88, Number 204 (Tuesday, October 24, 2023)]
[Notices]
[Pages 73013-73017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23471]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0061; FRL-10581-09-OCSPP]

Certain New Chemicals; Receipt and Status Information for 
September 2023

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 9/1/
2023 to 9/30/2023.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before November 24, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2023-0061, 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 9/01/2023 to 9/30/2023. The Agency is providing notice of 
receipt of PMNs,

[[Page 73014]]

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 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

[[Page 73015]]

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.

                        Table I--PMN/SNUN/MCANs Approved * From 09/01/2023 to 09/30/2023
----------------------------------------------------------------------------------------------------------------
      Case No.        Version   Received date     Manufacturer           Use              Chemical substance
----------------------------------------------------------------------------------------------------------------
J-23-0005..........         1      08/30/2023  CBI..............  (G) Production of  (G) Microorganisms
                                                                   an enzyme.         transformed to express and
                                                                                      enzyme.
J-23-0006..........         1      08/30/2023  CBI..............  (G) Production of  (G) Microorganisms
                                                                   an enzyme.         transformed to express and
                                                                                      enzyme.
P-21-0143A.........         4      09/25/2023  CBI..............  (G) Coating and    (G) Aliphatic Diisocyanate,
                                                                   adhesive           homopolymer, aliphatic
                                                                   ingredient.        alcohol blocked.
P-21-0215A.........         2      09/01/2023  Coventya, Inc....  (S) The PMN        (S) Pyridinium, 3-carboxy-1-
                                                                   substance is       methyl-, inner salt.
                                                                   used in a
                                                                   primarily
                                                                   aqueous alkaline
                                                                   electroplating
                                                                   solution that
                                                                   produces a
                                                                   nominal zinc
                                                                   (Zn) nickel (Ni)
                                                                   alloy deposit on
                                                                   iron bearing
                                                                   substrates.
P-22-0011A.........         5      08/24/2023  Lord Corporation.  (G)                (G) Alkadiene, homopolymer,
                                                                   Functionalized     hydroxy-terminated, bis[N-
                                                                   rubber in resin    [2-[(1-oxo-2-propen-1-
                                                                   side of two        yl)oxylethyl]carbamates].
                                                                   component epoxy
                                                                   modified acrylic
                                                                   adhesive.
P-22-0024A.........         3      09/25/2023  CBI..............  (G) Ingredient in  (G) Amino salt, polymer
                                                                   Industrial         with 1,6-
                                                                   Coating.           diisocyanatohexane, oxime-
                                                                                      and glycol ether-blocked.
P-22-0043A.........         3      09/13/2023  CBI..............  (G) Intermediate.  (G) Fatty acids,
                                                                                      hydroxyethoxy ethyl
                                                                                      esters.
P-22-0151A.........         7      08/28/2023  CBI..............  (G) Surfactant     (G) Glycolipids, sophorose-
                                                                   for commercial     contg., yeast-fermented,
                                                                   applications.      from glycerides and
                                                                                      carbohydrates.
P-22-0157A.........         2      09/01/2023  Evonik             (S) Polyurethane   (S) 1,2-Ethanediamine,
                                                Corporation.       catalyst.          N1,N2-dimethyl-N1-(1-
                                                                                      methylethyl)-N2-[2-
                                                                                      [methyl(1-
                                                                                      methylethyl)amino]ethyl]-.
P-22-0157A.........         3      09/07/2023  Evonik             (S) Polyurethane   (S) 1,2-Ethanediamine,
                                                Corporation.       catalyst.          N1,N2-dimethyl-N1-(1-
                                                                                      methylethyl)-N2-[2-
                                                                                      [methyl(1-
                                                                                      methylethyl)amino]ethyl]-.
P-22-0168..........         2      09/11/2023  Colonial           (S) The product    (G) Amides, alkyl, N-[3-
                                                Chemical, Inc.     is used as a       (dimethylamino)propyl].
                                                                   reaction
                                                                   intermediate to
                                                                   make surfactant
                                                                   end-products. It
                                                                   is not sold
                                                                   commercially or
                                                                   used outside of
                                                                   our
                                                                   manufacturing
                                                                   facility.
P-22-0168A.........         3      09/25/2023  Colonial           (S) The product    (G) Amides, alkyl, N-[3-
                                                Chemical, Inc.     is used as a       (dimethylamino)propyl].
                                                                   reaction
                                                                   intermediate to
                                                                   make surfactant
                                                                   end-products. It
                                                                   is not sold
                                                                   commercially or
                                                                   used outside of
                                                                   our
                                                                   manufacturing
                                                                   facility.
P-22-0175A.........         3      09/06/2023  Wacker Chemical    (S) Polymer Resin  (G) Modified
                                                Corporation.       Binder for         Silsesquioxane, alkoxy-
                                                                   composite stone    terminated.
                                                                   (Engineered
                                                                   Stone).
P-23-0022A.........         2      09/08/2023  Cabot Corporation  (G) Additive used  (G) Multi-walled carbon
                                                                   in industrial      nanotubes.
                                                                   applications.
P-23-0023A.........         2      09/08/2023  Cabot Corporation  (G) Additive used  (G) Multi-walled carbon
                                                                   in industrial      nanotubes.
                                                                   applications.
P-23-0024A.........         2      09/08/2023  Cabot Corporation  (G) Additive used  (G) Multi-walled carbon
                                                                   in industrial      nanotubes.
                                                                   applications.
P-23-0033A.........         2      09/08/2023  Cabot Corporation  (G) Additive used  (G) Multi-walled carbon
                                                                   in industrial      nanotubes.
                                                                   applications.
P-23-0077A.........         3      08/31/2023  CBI..............  (G) Additive for   (G) Alkanepolyoxy acid,
                                                                   industrial         alkyl substituted.
                                                                   applications.
P-23-0077A.........         4      09/01/2023  CBI..............  (G) Additive for   (G) Alkanepolyoxy acid,
                                                                   industrial         alkyl substituted.
                                                                   applications.
P-23-0154A.........         3      09/20/2023  RWDC Industries..  (G) The primary    (G) Vegetable oils,
                                                                   application        genetically modified
                                                                   areas for PHA      Cupriavidus-fermented,
                                                                   are for food       polyhydroxyalkanoate
                                                                   packaging and      copolymer.
                                                                   other uses where
                                                                   its
                                                                   biodegradable
                                                                   properties
                                                                   provide
                                                                   nontraditional
                                                                   end-of-use
                                                                   options.

[[Page 73016]]

 
P-23-0163..........         2      09/06/2023  CBI..............  (G) Surface        (S) 1,2-Ethanediamine, N1-
                                                                   coating.           [3-
                                                                                      (trimethoxysilyl)propyl]-,
                                                                                      hydrolysis products with 3-
                                                                                      (trimethoxysilyl)-N-[3-
                                                                                      (trimethoxysilyl)propyl]-1-
                                                                                      propanamine, nitrates
                                                                                      (salts).
P-23-0171..........         2      09/06/2023  Interplastic       (G) Polyester      (S) 1,2,3-
                                                Corporation.       Resin Additive.    Propanetricarboxylic acid,
                                                                                      2-hydroxy-, octyl ester.
P-23-0172A.........         2      09/13/2023  CBI..............  (G)                (G) Sulfonium,
                                                                   Photolithography.  tricarbocyclic-,
                                                                                      alkylcarbomocyclic-
                                                                                      polyfluoro-
                                                                                      heteropolycyclic-alkyl
                                                                                      sulfonate (1:1), polymer
                                                                                      with alkylaryl and
                                                                                      carbomonocyclic alkyl
                                                                                      alkanoate, di-Me 2,2'-(1,2-
                                                                                      diazenediyl)bis[2-
                                                                                      alkylalkanoate]-initiated.
P-23-0175..........         2      09/27/2023  CBI..............  (G) rinse          (G)
                                                                   material for       Bis(fluoroalkylsubstituted
                                                                   photolithography.  ) sulfonyl sulfonamide.
P-23-0176..........         1      09/06/2023  CBI..............  (G) An ingredient  (G) Sulfonium, bis(dihalo
                                                                   used in the        carbomonocycle)carbomonocy
                                                                   manufacture of     cle-, salt with dihalo-
                                                                   photoresist.       sulfoalkyl trisubstituted
                                                                                      benzoate.
P-23-0177..........         2      09/19/2023  Colonial           (G) Corrosion      (G) fatty acids, vegetable
                                                Chemical, Inc.     inhibitor.         oil, reaction products
                                                                                      with diethylenetriamine.
P-23-0178..........         1      09/07/2023  CBI..............  (S) Lens resins    (S) Benzenamine, 4,4'-(9H-
                                                                   for                fluoren-9-ylidene)bis-.
                                                                   photoelectric
                                                                   conversion
                                                                   adapters.
P-23-0179..........         1      09/08/2023  CBI..............  (G) An ingredient  (G) Sulfonium,
                                                                   used in the        bis(dihalocarbomonocycle)c
                                                                   manufacture of     arbomonocycle-, salt with
                                                                   photoresist.       substituted-
                                                                                      dihalobenzoate.
P-23-0181..........         1      09/13/2023  CBI..............  (G) Used as        (G) Alkanedioic acid,
                                                                   adhesive.          polymer with mixed
                                                                                      alkanediol, polyalkyl
                                                                                      glycol, carbomonocycle
                                                                                      carbomonocycle, alkane
                                                                                      carbopolycycle
                                                                                      diisocyanate.
P-23-0182..........         1      09/15/2023  CBI..............  (G) Base oils in   (G) Cyclic ether, polymer
                                                                   lubricants.        with 2-methyloxirane and
                                                                                      oxirane, monobutyl ether.
P-23-0183..........         2      09/22/2023  CBI..............  (G) Additive in    (G) Ethyl Modified Lactam.
                                                                   paints, coatings
                                                                   and inks, paint
                                                                   removal
                                                                   formulations,
                                                                   wire coatings.
P-23-0184..........         2      09/25/2023  CBI..............  (G) Intermediate.  (G) Perfluorosulfonyl
                                                                                      fluoride polymer, with
                                                                                      perfluorodioxolane.
P-23-0185..........         2      09/25/2023  CBI..............  (G) Intermediate.  (G) Perfluorosulfonic acid
                                                                                      polymer, salt, with
                                                                                      perfluorodioxolane.
P-23-0186..........         2      09/25/2023  CBI..............  (G) Dispersive     (G) Perfluorosulfonic acid
                                                                   Use.               polymer, with
                                                                                      perfluorodioxolane.
P-23-0187..........         1      09/21/2023  CBI..............  (S) Polymer for    (G) Substituted
                                                                   use in powder      benzenedicarboxylic acid,
                                                                   and tablet         sodium salt, polymer with
                                                                   laundry            benzenedicarboxylic acids
                                                                   detergent          and 1,2-ethanediol.
                                                                   formulations.
P-23-0188..........         2      09/27/2023  CBI..............  (G) Destructive    (G) Alkenoic acid, 3-methyl-
                                                                   Use.               , 1,1-dimethyl-2-propen-1-
                                                                                      yl ester; Alkenoic acid, 3-
                                                                                      methyl-, 1,1-dimethyl-2-
                                                                                      propen-1-yl ester;.
P-23-0189..........         1      09/25/2023  CBI..............  (G) Component in   (G)
                                                                   polymers.          Dimethanocarbopolycycle,
                                                                                      alkyl-polyhydro-.
P-23-0191..........         1      09/25/2023  CBI..............  (G)                (G) Sulfonium,
                                                                   Photolithography.  tricarbocyclic-,
                                                                                      heteroatom-substituted-
                                                                                      (halocarbocyclic)carboxyla
                                                                                      te (1:1).
----------------------------------------------------------------------------------------------------------------

    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 09/01/2023 to 09/30/2023
----------------------------------------------------------------------------------------------------------------
                                                              If amendment, type of
        Case No.           Received date  Commencement date         amendment             Chemical substance
----------------------------------------------------------------------------------------------------------------
J-22-0023...............      09/28/2023         09/15/2023  N                       (G) Microorganisms stably
                                                                                      transformed to manufacture
                                                                                      PHA.
J-22-0024...............      09/29/2023         09/20/2023  N                       (G) Microorganisms stably
                                                                                      transformed to manufacture
                                                                                      PHA.

[[Page 73017]]

 
J-22-0025...............      09/29/2023         09/29/2023  N                       (G) Microorganisms stably
                                                                                      transformed to manufacture
                                                                                      PHA.
J-23-0004...............      09/18/2023         09/11/2023  N                       (G) Genetically modified
                                                                                      microorganism.
P-21-0073...............      09/25/2023         09/07/2023  N                       (S) 4-
                                                                                      cyclohexanedicarboxylic
                                                                                      acid, 1,4-dinonyl ester,
                                                                                      branched and linear.
P-21-0175...............      09/29/2023         09/22/2023  N                       (G) Polycarbonate diol/
                                                                                      benebiol nldb grade.
P-97-0954A..............      09/21/2023         10/23/2020  Amended generic         (G) Isocyanic acid,
                                                              chemical name.          polymethylenepolyphenylene
                                                                                      ester, polymer with
                                                                                      .alpha.,.alpha.'-[(1-
                                                                                      methylethylidene)di-4,1-
                                                                                      phenylene]bis[.omega.-
                                                                                      hydroxypoly(oxyalkanediyl)
                                                                                      ] and 1,2-alkanediol, 2-
                                                                                      alkoxyethanol-blocked.
----------------------------------------------------------------------------------------------------------------
* 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 09/01/2023 to 09/30/2023
------------------------------------------------------------------------
                                       Type of test         Chemical
     Case No.        Received date     information         substance
------------------------------------------------------------------------
P-16-0543.........      09/01/2023  Exposure           (G)
                                     Monitoring         Halogenophosphor
                                     Report.            ic acid metal
                                                        salt.
P-16-0543.........      09/01/2023  Exposure           (G)
                                     Monitoring         Halogenophosphor
                                     Report.            ic acid metal
                                                        salt.
P-18-0304.........      09/06/2023  Partition          (G) Sulfonium,
                                     Coefficient (n-    bis(dihalocarbom
                                     octanol/water),    onocycle)
                                     Shake Flask        carbomonocycle,
                                     Method (OECD       salt with
                                     Test Guideline     substituted
                                     107); Partition    heteropolycycle
                                     Coefficient (n-    dihalo
                                     octanol/water),    sulfoalkanoate
                                     Estimation by      (1:1).
                                     Liquid
                                     Chromatography
                                     (OECD Test
                                     Guideline 117).
P-22-0046.........      09/01/2023  Published Studies  (S) Fibroins.
                                     on Allergenicity.
P-22-0128.........      09/20/2023  Mass               (G) Alkyl
                                     Spectrometry, IR   cycloalkane,
                                     Spectrometry,      polyfluoro-.
                                     NMR Testing Data.
------------------------------------------------------------------------

    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: October 18, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2023-23471 Filed 10-23-23; 8:45 am]
BILLING CODE 6560-50-P