[Federal Register Volume 89, Number 12 (Thursday, January 18, 2024)]
[Notices]
[Pages 3397-3401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00891]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0061; FRL-10581-12-OCSPP]


Certain New Chemicals; Receipt and Status Information for 
December 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 12/01/
2023 to 12/31/2023.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before February 20, 2024.

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 12/01/2023 to 12/31/2023. 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);

[[Page 3398]]

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.

                                            Table I--PMN/SNUN/MCANs Approved * From 12/01/2023 to 12/31/2023
--------------------------------------------------------------------------------------------------------------------------------------------------------
             Case No.               Version          Received date              Manufacturer               Use                  Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
J-24-0001.........................        1                    12/13/2023  CBI..................  (G) Chemical           (G) Chromosomally-modified
                                                                                                   production.            Saccharomyces cerevisiae.
J-24-0002.........................        1                    12/13/2023  CBI..................  (G) Chemical           (G) Chromosomally-modified
                                                                                                   production.            Saccharomyces cerevisiae.
P-16-0404A........................        7                    12/01/2023  CBI..................  (G) A colorant for     (G) Alkyl ester, 2-({4-[2-
                                                                                                   dyeing various         (trisubstituted phenyl)azo]-5-
                                                                                                   synthetic fibers and   acetamido-2-
                                                                                                   fabrics. Open, non-    substitutedphenyl{time}
                                                                                                   dispersive use.        (substituted alkoxy)amino).
P-20-0092A........................        9                    12/01/2023  CBI..................  (G) Coloration of      (G) Napthalenesulfonic acid,
                                                                                                   fabric.                amino-hydroxy-bis [sulfo-
                                                                                                                          [(sulfooxy)ethyl]sulfonyl]phen
                                                                                                                          yl]diazinyl]-,potassium sodium
                                                                                                                          salt.
P-22-0002A........................        5                    12/06/2023  Materion Advanced      (G) This product is    (G) Metal Oxide Chloride.
                                                                            Chemicals.             used for the
                                                                                                   manufacturing of
                                                                                                   electronic devices.
P-22-0011A........................        6                    12/20/2023  CBI..................  (G) Functionalized     (G) Alkadiene, homopolymer,
                                                                                                   rubber in resin side   hydroxy-terminated, bis[N-[2-
                                                                                                   of two component       [(1-oxo-2-propen-1-
                                                                                                   epoxy modified         yl)oxylethyl]carbamates].
                                                                                                   acrylic adhesive.
P-22-0113A........................        6                    12/12/2023  Solugen, Inc.........  (G) Chemical           (S) D-Glucaric acid.
                                                                                                   intermediate,
                                                                                                   Additive.
P-23-0148.........................        1                    06/22/2023  CBI..................  (G) Inert component    (G) Amylopectin, 2-
                                                                                                   in Pesticides.         hydroxypropyl ether, modified.

[[Page 3399]]

 
P-23-0172A........................        3                    12/18/2023  CBI..................  (G) Photolithography.  (G) Sulfonium, tricarbocyclic-,
                                                                                                                          alkylcarbomonocyclic-
                                                                                                                          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-24-0006.........................        2                    12/19/2023  CBI..................  (S) Oilfield           (G) Polymeric salt of Propenoic
                                                                                                   Production Scale       acid, Acrylamido-methylpropane
                                                                                                   Inhibitor.             sulfonic acid sodium salt,
                                                                                                                          Hydroxyethyl methacrylate,
                                                                                                                          Methyl methacrylate, Propenoic
                                                                                                                          acid, methyl-,
                                                                                                                          phosphinicobis(oxy-ethanediyl)
                                                                                                                          ester, Sodium Metabisulfite.
P-24-0016.........................        3                    11/29/2023  Huntsman               (S) Catalyst in 2-     (S) 2-Propanamine, N ,N'-(oxydi-
                                                                            International, LLC.    part polyurethane      2,1-ethanediyl)bis[N-methyl-.
                                                                                                   spray foam
                                                                                                   insulation
                                                                                                   application.
P-24-0034.........................        1                    11/27/2023  Barentz North          (S) Elcosol DM has     (S) 2,5,7,10-Tetraoxaundecane,
                                                                            America, LLC.          widespread use as a    4,8-dimethyl-.
                                                                                                   non-reactive
                                                                                                   processing aid (no
                                                                                                   inclusion into or
                                                                                                   onto article), the
                                                                                                   substance is not
                                                                                                   included in the
                                                                                                   final article as it
                                                                                                   evaporates. There is
                                                                                                   no intended consumer
                                                                                                   use for this
                                                                                                   application.
                                                                                                  (S) In cleaning
                                                                                                   products, Elcosol DM
                                                                                                   has widespread use
                                                                                                   as a non-reactive
                                                                                                   processing aid (no
                                                                                                   inclusion into or
                                                                                                   onto article). The
                                                                                                   substance is not
                                                                                                   included in the
                                                                                                   final article it is
                                                                                                   recycled or
                                                                                                   recuperated for
                                                                                                   treatment/
                                                                                                   appropriate
                                                                                                   disposal; waters are
                                                                                                   treated through a
                                                                                                   biological sewage
                                                                                                   treatment process
                                                                                                   (STP). In consumer
                                                                                                   products the NCS is
                                                                                                   used as a solvent or
                                                                                                   cosolvent.
                                                                                                  (S) For use in
                                                                                                   laboratories,
                                                                                                   Elcosol DM is not
                                                                                                   included in the
                                                                                                   final article: it is
                                                                                                   recycled or
                                                                                                   recuperated for
                                                                                                   treatment/
                                                                                                   appropriate
                                                                                                   disposal, waters are
                                                                                                   treated through a
                                                                                                   biological sewage
                                                                                                   treatment process
                                                                                                   (STP). There is no
                                                                                                   consumer use of this
                                                                                                   NCS for this
                                                                                                   application.
                                                                                                  (S) Elcosol DM is
                                                                                                   used in consumer
                                                                                                   cleaning products as
                                                                                                   a solvent or
                                                                                                   cosolvent. The use
                                                                                                   of the substance by
                                                                                                   consumers is
                                                                                                   expected to fall
                                                                                                   under do-it yourself
                                                                                                   (DIY) cleaning
                                                                                                   products such as
                                                                                                   glue removers, paint
                                                                                                   strippers, hard
                                                                                                   stain removers.
P-24-0036.........................        3                    12/18/2023  CBI..................  (G) Intermediate.....  (G) Poly(oxy-alkylene), alpha-
                                                                                                                          alkenyl-omega-hydroxy-,.
P-24-0040.........................        2                    12/15/2023  Sudoc, LLC...........  (G) Additive for       (G) Metal,
                                                                                                   commercial             aqua[(alkylnitrocarbocyclepoly
                                                                                                   applications.          heteropolyheterocyclopolyalkan
                                                                                                   Additive for non-      e-ketone)-polyoxidato]-,
                                                                                                   spray commercial and   metal.
                                                                                                   consumer
                                                                                                   applications.
P-24-0042.........................        1                    12/15/2023  CBI..................  (G) An ingredient      (G) Sulfonium,
                                                                                                   used in the            bis(dihalocarbomonocycle)carbo
                                                                                                   manufacture of         monocycle-, salt with (dihalo-
                                                                                                   photoresist.           sulfoalkyl) (halo-substituted
                                                                                                                          carbomonocycle)
                                                                                                                          carbopolycycle.
P-24-0043.........................        1                    12/19/2023  Clariant Corporation.  (S) Catalyst for use   (S) Iron potassium oxide
                                                                                                   in petrochemical       (FeKO2).
                                                                                                   operations.
P-24-0044.........................        1                    12/21/2023  CBI..................  (G) Component in       (G) Oxirane, 2-methyl-, polymer
                                                                                                   polyurethane and       with oxirane, ether with N-[4-
                                                                                                   other thermoset        [[4-[bis(2-
                                                                                                   resins.                hydroxyethyl)amino]phenyl](2-
                                                                                                                          substitutedphenyl)methylene]-
                                                                                                                          2,5-cyclohexadien-1-ylidene]-2-
                                                                                                                          hydroxy-N-(2-
                                                                                                                          hydroxyethyl)ethanaminium
                                                                                                                          inner salt (4:1).
P-24-0045.........................        1                    12/21/2023  CBI..................  (G) Coating and        (G) Cashew, nutshell liq.,
                                                                                                   Adhesives.             polymer with epichlorohydrin
                                                                                                                          and glycol.
SN-22-0007A.......................        6                    12/29/2023  Braven Environmental,  (G) Product of         (S) Waste plastics, pyrolyzed,
                                                                            LLC.                   Pyrolysis              C5-12 fraction.
                                                                                                   manufacturing.
SN-22-0008A.......................        6                    12/29/2023  Braven Environmental,  (G) Product of         (S) Waste plastics, pyrolyzed,
                                                                            LLC.                   Pyrolysis              C20-55 fraction.
                                                                                                   Manufacturing.

[[Page 3400]]

 
SN-22-0009A.......................        6                    12/29/2023  Braven Environmental,  (G) Product of         (S) Waste plastics, pyrolyzed,
                                                                            LLC.                   Pyrolysis              C9-20 fraction.
                                                                                                   Manufacturing.
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    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 12/01/2023 to 12/31/2023
----------------------------------------------------------------------------------------------------------------
                                     Received     Commencement     If amendment, type
             Case No.                  date           date            of amendment         Chemical substance
----------------------------------------------------------------------------------------------------------------
P-21-0168........................   12/28/2023        12/04/2023  N...................  (G) Metal,
                                                                                         [heteropolycyclic]-,
                                                                                         [[[(hydroxyalkyl)amino]
                                                                                         sulfonyl]alkyl]sulfonyl
                                                                                         (sulfoalkyl)sulfonyl
                                                                                         derivs., ammonium
                                                                                         sodium salts,.
P-22-0054........................   12/19/2023        10/17/2023  N...................  (G) Graphene
                                                                                         nanoplatelets.
P-22-0127........................   12/14/2023        12/01/2023  N...................  (S) Urea, n,n'-bis[3-
                                                                                         [[(4-
                                                                                         methylphenyl)sulfonyl]o
                                                                                         xy]phenyl]-.
----------------------------------------------------------------------------------------------------------------

    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 12/01/2023 to 12/31/2023
----------------------------------------------------------------------------------------------------------------
                                             Received
                 Case No.                      date       Type of test information        Chemical substance
----------------------------------------------------------------------------------------------------------------
P-17-0339................................   12/19/2023  Simulation Test--Aerobic     (S) Poly(oxy-1,2-
                                                         Sewage Treatment--A:         ethanedlyl)-alpha-(2-butyl
                                                         Activated Sludge Units       (1-octyl \14\C))-omega-
                                                         (OECD Test Guideline 303A).  hydroxy alcohol.
P-19-0166................................   12/06/2023  Partition Coefficient (n-    (G) Triarylsulfonium
                                                         octanol/water), Shake        alkylestersulfonate,.
                                                         Flask Method (OECD Test
                                                         Guideline 107); Partition
                                                         Coefficient (n-octanol/
                                                         water), Estimation by
                                                         Liquid Chromatography
                                                         (OECD Test Guideline 117).
P-23-0165................................   12/15/2023  Combined Repeated Dose       (G) 2,3,3,3-tetrafluoro-2-
                                                         Toxicity with the            [(polyfluoroalken-1-
                                                         Reproduction/Development     yl)oxy]-propanoic acid
                                                         Toxicity Screening Test      homopolymer.
                                                         (OECD Test Guideline 422).
P-10-0470................................   12/19/2023  Analytical Information.....  (G) Fluoro modified,
                                                                                      polyether modified and
                                                                                      alkyl modified
                                                                                      polymethylsiloxane.
P-10-0471................................   12/19/2023  Analytical Information.....  (G) Fluoro modified,
                                                                                      polyether modified
                                                                                      polyacrylate.
P-10-0472................................   12/19/2023  Analytical Information.....  (G) Fluoro modified,
                                                                                      polyether modified
                                                                                      polyacrylate.
P-20-0042, P-18-0016.....................    12/4/2023  Direct Photolysis Study      (G) Sulfonium, trisaryl-,
                                                         Report.                      7,7-dialkyl-2-
                                                                                      heteropolycyclic-1-
                                                                                      alkanesulfonate (1:1); (G)
                                                                                      Aromatic sulfonium
                                                                                      tricyclo fluoroalkyl
                                                                                      sulfonic acid salt.
P-18-0304, P-18-0316, P-18-0338, P-19-      12/12/2023  PAG 2 Direct Photolysis      (G) Sulfonium,
 0076, P-19-0115, P-19-0142, P-20-0120, P-               Study Report.                bis(dihalocarbomonocycle)
 21-0027.                                                                             carbomonocycle, salt with
                                                                                      substituted
                                                                                      heteropolycycle dihalo
                                                                                      sulfoalkanoate (1:1).
                                                                                     (G) Heteropolycycle,
                                                                                      alkylaromatic-, salt with
                                                                                      dihalo-substituted alkyl
                                                                                      carbopolycycle
                                                                                      carboxylate.
                                                                                     (G) Sulfonium, triaryl-,
                                                                                      salt with polyhalo-4-
                                                                                      sulfoalkyl polycarbocyclic
                                                                                      alkane-1-carboxylate
                                                                                      (1:1).
                                                                                     (G) Sulfonium,
                                                                                      bis(dihalocarbomonocycle)
                                                                                      carbomonocycle, salt with
                                                                                      dihalo substituted alkyl
                                                                                      carbopolycyclic
                                                                                      carboxylate (1:1).
                                                                                     (G) Sulfonium,
                                                                                      bis(dihalocarbomonocycle)
                                                                                      carbomonocycle,
                                                                                      substituted
                                                                                      carbomonocyclic ester.
                                                                                     (G) Heteropolycycle,
                                                                                      aromatic-, salt with
                                                                                      dihalo-substituted alkyl
                                                                                      carbopolycycle carboxylate
                                                                                      (1:1).
                                                                                     (G) Carbomonocyclic
                                                                                      sulfonium, salt with
                                                                                      trihalo-sulfoalkyl
                                                                                      hydroxycarbopolycyclic
                                                                                      carboxylate.
                                                                                     (G) Heteropolycyclic,
                                                                                      trihaloalkyl
                                                                                      carbomonocycle-, hydroxy
                                                                                      carbomonocyclic 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.


[[Page 3401]]


    Dated: January 11, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2024-00891 Filed 1-17-24; 8:45 am]
BILLING CODE 6560-50-P