Document ID: EPA-HQ-OPPT-2023-0061-0027
Agency: epa
Document Type: Notice
Title: Certain New Chemicals: Status Information for November 2023
Posted Date: 2023-12-22T05:00Z

[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88606-88609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28240]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0061; FRL-10581-11-OCSPP]

Certain New Chemicals; Receipt and Status Information for 
November 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 11/01/
2023 to 11/30/2023.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before January 22, 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

[[Page 88607]]

of Pollution Prevention and Toxics, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-8593; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the 
period from 11/01/2023 to 11/30/2023. 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); 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

[[Page 88608]]

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 11/01/2023 to 11/30/2023
----------------------------------------------------------------------------------------------------------------
                                     Received
        Case No.          Version      date        Manufacturer           Use             Chemical substance
----------------------------------------------------------------------------------------------------------------
J-23-0005A.............         2   09/26/2023  CBI..............  (G) Production of  (G) Microorganisms
                                                                    an enzyme.         transformed to express an
                                                                                       enzyme.
J-23-0006A.............         2   09/26/2023  CBI..............  (G) Production of  (G) Microorganisms
                                                                    an enzyme.         transformed to express an
                                                                                       enzyme.
P-22-0113A.............         5   11/02/2023  SOLUGEN INC......  (G) Chemical       (S) D-Glucaric acid.
                                                                    intermediate,
                                                                    Additive.
P-22-0123A.............         4   11/13/2023  CBI..............  (G) Mineral        (G) Propaneamine, 3-
                                                                    processing aid.    (alkyloxy)-, structural
                                                                                       variants.
P-22-0140A.............         4   11/28/2023  Colonial           (G) Corrosion      (G) 6-[(alkyl-1-
                                                 Chemical, Inc.     inhibitor.         oxohexyl)amino]-hexanoic
                                                                                       acid, compd. with
                                                                                       cyclohexylamine (1:1).
P-23-0069A.............         4   11/08/2023  CBI..............  (S) Encapsulating  (G) Pisum sativum oil,
                                                                    Shell Polymer      glycerol, crosspolymer
                                                                    for Fragrance;     with linear and cyclic
                                                                    Encapsulates for   aliphatic isocyanates.
                                                                    Industrial or
                                                                    Household
                                                                    Consumer
                                                                    Products such as
                                                                    Detergents and
                                                                    Fabric Softeners.
P-24-0001..............         1   10/03/2023  Cabot Corporation  (G) Additive used  (G) Carbon Nanostructures,
                                                                    in industrial      purified.
                                                                    applications.
P-24-0005A.............         8   11/16/2023  CBI..............  (G) Plastic        (G) Polycarbomonocyclic
                                                                    article            diol reaction products
                                                                    production.        with
                                                                                       cycloalkylcarbomonocycle
                                                                                       and polysubstituted
                                                                                       heteromonocycle.
P-24-0007..............         2   11/08/2023  Kenrich            (S) Use as a       (S) Titanium, branched and
                                                 Petrochemicals,    dispersant for     linear C16-18 and C18-
                                                 Inc.               powders, all       unsatd. fatty acids iso-
                                                                    forms KR PTOA,     Pr alc. complexes.
                                                                    CAPOW KR PTOA
                                                                    and CAPS KR
                                                                    PTOA.; Use as an
                                                                    adhesion
                                                                    promoter in
                                                                    adhesives and
                                                                    sealants all
                                                                    forms KR PTOA,
                                                                    CAPOW KR PTOA
                                                                    and CAPS KR PTOA.
P-24-0024..............         1   11/08/2023  Enchem America,    (G) Electrolyte    (G) Heteroatom-substituted
                                                 LLC.               additive.          dihalo acid, methyl
                                                                                       substituted-alkyl ester.
P-24-0030..............         1   11/10/2023  Barentz North      (S) 2-             (S) Heptane, 3,3'-
                                                 America, LLC.      Ethylhexylal       [methylenebis(oxymethylen
                                                                    currently has      e)]bis- (9CI, ACI).
                                                                    widespread use
                                                                    as a functional
                                                                    fluid in
                                                                    lubricants,
                                                                    greases, and
                                                                    other release
                                                                    products; 2-
                                                                    Ethylhexylal
                                                                    currently has
                                                                    widespread use
                                                                    in laboratories
                                                                    as a non-
                                                                    reactive
                                                                    processing aid
                                                                    with no
                                                                    inclusion into
                                                                    or onto the
                                                                    article.; 2-
                                                                    Ethylhexylal is
                                                                    also used in
                                                                    consumer
                                                                    products as a
                                                                    solvent or
                                                                    cosolvent in
                                                                    coating products.
P-24-0032..............         1   11/15/2023  Equinor Marketing  (S) Hydrocarbon    (S) Naphtha (glyceridic),
                                                 & Trading (US),    value for fuel     light catalytic cracked.
                                                 Inc.               applications
                                                                    (e.g., use in
                                                                    motor fuel,
                                                                    blending stock
                                                                    for other fuels).
----------------------------------------------------------------------------------------------------------------

    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

[[Page 88609]]

received by EPA, the date of commencement provided by the submitter in 
the NOC, a notation of the type of amendment (e.g., amendment to 
generic name, specific name, technical contact information, etc.) and 
chemical substance identity.

                                                 Table II--NOCs Approved * From 11/01/2023 to 11/30/2023
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Commencement
                Case No.                   Received date        date         If amendment, type of amendment              Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-16-0313...............................      11/15/2023        11/02/2023  N                                 (S) Tar acids (shale oil), C6-9 fraction,
                                                                                                               alkylphenols, low-boiling.
P-18-0158...............................      11/28/2023        11/01/2023  N                                 (G) Sulfonium, triphenyl-, salt with 2,3-
                                                                                                               bis(substituted) 5-sulfocarbopolycyclic-
                                                                                                               2,3-carboxylate derivative (1:1).
P-20-0054...............................      11/07/2023        10/07/2020  N                                 (S) Nitrile Hydratase.
P-20-0178A..............................      11/29/2023        08/02/2023  Amended Generic Chemical Name     (G) Carbopolycyclic alkenyl, 2-carboxylic
                                                                                                               acid, 2-[[[[[(isocyanatophenyl)alkyl]
                                                                                                               carbocycle]-amino]carbonyl]oxy]ethyl
                                                                                                               ester.
P-21-0042...............................      11/28/2023        11/01/2023  N                                 (G) Sulfonium, tricarbocyclic-, 2-
                                                                                                               heteroatom-substituted-4-
                                                                                                               (alkyl)carbomonocyclic carboxylate (1:1).
P-21-0131...............................      11/28/2023        11/01/2023  N                                 (G) Sulfonium, tricarbocyclic-, 2-(4-
                                                                                                               alkoxyhalocarbomonocyclic)-alpha, alpha,
                                                                                                               beta, beta-polyhalopolyhydro-4,7-methano-
                                                                                                               1,3-heteropolycyclic-5-alkanesulfonate
                                                                                                               (1:1).
P-22-0018...............................      11/20/2023        11/03/2023  N                                 (G) Substituted polyalkylenepoly, reaction
                                                                                                               products with substituted heteromonocycle
                                                                                                               substituted heteromonocycle polyalkylene
                                                                                                               derivs.
P-22-0022...............................      11/14/2023        11/04/2023  N                                 (G) Aryl-substituted-heterocyclic-
                                                                                                               polyamine, reaction products with
                                                                                                               polyethylene glycol alkyl-ether, and
                                                                                                               nitrogen and alkyl-substituted benzene.
P-23-0013...............................      11/17/2023        11/15/2023  N                                 (S) Phenol, polymer with 4,4'-
                                                                                                               bis(chloromethyl)-1,1'-biphenyl.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

                       Table III--Test Information Received From 11/01/2023 to 11/30/2023
----------------------------------------------------------------------------------------------------------------
                                                                  Type of test
              Case No.                    Received date           information             Chemical substance
----------------------------------------------------------------------------------------------------------------
L-23-0173...........................            11/22/2023  Algal Toxicity (OECD     (G) Cis-Alkenoic Acid.
                                                             Test Guideline 201).
P-16-0543...........................            11/21/2023  Exposure Monitoring      (G) Halogenophosphoric acid
                                                             Report.                  metal salt.
P-23-0017...........................            11/29/2023  Human Repeated Insult    (G) Hydrolyzed collagen,
                                                             Patch Testing.           polymer with aromatic
                                                                                      isocyanate, n-
                                                                                      triethoxysylil-alkanamine,
                                                                                      pectic polysaccharide and
                                                                                      poly alkyl alcohol.
----------------------------------------------------------------------------------------------------------------

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

    Dated: December 18, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2023-28240 Filed 12-21-23; 8:45 am]
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