[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68899-68902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19304]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2024-0057; FRL-11683-07-OCSPP]


Certain New Chemicals; Receipt and Status Information for July 
2024

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 7/01/
2024 to 7/31/2024.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before September 27, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2024-0057, 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 7/01/2024 to 7/31/2024. 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

[[Page 68900]]

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 7/01/2024 to 7/31/2024
----------------------------------------------------------------------------------------------------------------
                                      Received
        Case No.           Version      date        Manufacturer             Use            Chemical substance
----------------------------------------------------------------------------------------------------------------
P-20-0031...............         1   07/17/2024  CBI...............  (G) Intermediate..  (G) Perfluorinated
                                                                                          substituted 1,3-
                                                                                          oxathiolane dioxide.
P-20-0033...............         1   07/17/2024  CBI...............  (G) Intermediate..  (G) Perfluorinated
                                                                                          vinyl haloalkane
                                                                                          sulfonate salt.
P-20-0034...............         1   07/17/2024  CBI...............  (G) Intermediate..  (G) Perfluorinated
                                                                                          vinyl haloalkane
                                                                                          sulfonyl halide.
P-23-0014...............         1   07/22/2024  CBI...............  ..................  (G) [Polyalkyl-
                                                                                          methylenepolyhydro-
                                                                                          polycyclic]alkyl
                                                                                          acetate.
P-23-0177A..............         3   07/19/2024  Colonial Chemical,  (G) Corrosion       (G) fatty acids,
                                                  Inc.                inhibitor.          vegetable oil,
                                                                                          reaction products with
                                                                                          diethylenetriamine.
P-24-0027A..............         6   07/08/2024  Mikros Biochem....  (S) Surfactant for  (S) Fatty acids, C8-14,
                                                                      cleaners.           2,3-diesters with rel-
                                                                                          (2R, 3S)-2,3,4-
                                                                                          trihydroxybutyl Beta-D-
                                                                                          mannopyranoside
                                                                                          acetate.
P-24-0079A..............         4   07/12/2024  CBI...............  (G) Fuel Additive.  (G) Alkyated
                                                                                          succinimide.
P-24-0079A..............         5   07/19/2024  CBI...............  (G) Fuel Additive.  (G) Alkyated
                                                                                          succinimide.
P-24-0104A..............         5   07/17/2024  CBI...............  (G) Plastic         (G) carbomonocycle
                                                                      Additive.           alkylamide, 3,5-
                                                                                          bis(1,1-dialkyl) -4-
                                                                                          hydroxy-N-[2,5-dioxo-3-
                                                                                          (polyalkylene)-1-
                                                                                          heteromonocyclic]-.
P-24-0109A..............         3   07/09/2024  CBI...............  (G) Electrolyte     (G) Lithium dihalo
                                                                      salt.               (oxalato)borate(1-).
P-24-0109A..............         4   07/10/2024  CBI...............  (G) Electrolyte     (G) Lithium dihalo
                                                                      salt.               (oxalato)borate(1-).
P-24-0130A..............         3   07/12/2024  CBI...............  (S) Sulfur          (G)
                                                                      Scavenger.          poly(alkoxy)alkanol.
P-24-0161A..............         3   06/27/2024  Cargill,            (S) Feedstock for   (S) Fats and glyceridic
                                                  Incorporated.       production of       oils, camelina sativa.
                                                                      biofuel.            Extractives and their
                                                                                          physically modified
                                                                                          derivatives. It
                                                                                          consists primarily of
                                                                                          the glycerides of the
                                                                                          fatty acids
                                                                                          docosenoic,
                                                                                          eicosenoic, linoleic,
                                                                                          linolenic, oleic,
                                                                                          palmitic and stearic.
                                                                                          (Camelina sativa).
P-24-0161A..............         4   07/08/2024  Cargill,            (S) Feedstock for   (S) Fats and glyceridic
                                                  Incorporated.       production of       oils, camelina sativa.
                                                                      biofuel.            Extractives and their
                                                                                          physically modified
                                                                                          derivatives. It
                                                                                          consists primarily of
                                                                                          the glycerides of the
                                                                                          fatty acids
                                                                                          docosenoic,
                                                                                          eicosenoic, linoleic,
                                                                                          linolenic, oleic,
                                                                                          palmitic and stearic.
                                                                                          (Camelina sativa).

[[Page 68901]]

 
P-24-0162A..............         3   07/25/2024  Proton Power, Inc.  (S) Increases       (S) single and
                                                                      strength of         multilayer
                                                                      epoxy, plastics,    turbostratic graphene.
                                                                      moulding
                                                                      compounds,
                                                                      strength,
                                                                      modulus, tear
                                                                      resistance for
                                                                      polyurethane
                                                                      foam; Improves
                                                                      the rutting
                                                                      behavior of
                                                                      asphalt; Improves
                                                                      the capacity and
                                                                      thermal and
                                                                      electrical
                                                                      conductivity for
                                                                      batteries,
                                                                      strength of body
                                                                      armor and
                                                                      helmets, drying
                                                                      time and
                                                                      antifouling for
                                                                      paints.
P-24-0164A..............         2   07/09/2024  Huntsman            (S) Intermediate    (S) 2-Propanamine, N,N'-
                                                  International,      in the production   (oxydi-2,1-
                                                  LLC.                of a catalyst.      ethanediyl)bis-.
P-24-0171A..............         2   07/17/2024  CBI...............  (G) Making of air   (G) Metal and rare
                                                                      pollutants          earth metal zirconium
                                                                      control parts in    oxide.
                                                                      automobiles.
P-24-0172A..............         2   07/17/2024  CBI...............  (G) Manufacturing   (G) Metal and rare
                                                                      of air pollutants   earth metal zirconium
                                                                      control parts.      oxide.
P-24-0173...............         1   07/12/2024  CBI...............  (G) For making air  (G) Rare earth doped
                                                                      pollutant control   zirconium oxide
                                                                      parts in
                                                                      automobiles.
P-24-0174...............         1   07/12/2024  CBI...............  (G) Making air      (G) Rare earth doped
                                                                      pollutants          zirconium oxide.
                                                                      control parts in
                                                                      automobiles.
P-24-0175...............         1   07/12/2024  CBI...............  (G) Air pollutants  (G) Rare earth doped
                                                                      control parts in    zirconium oxide.
                                                                      automobiles.
P-24-0176...............         1   07/12/2024  CBI...............  (G) Making of air   (G) Rare earth doped
                                                                      pollutants          zirconium oxide.
                                                                      control parts in
                                                                      automobiles.
P-24-0177...............         1   07/12/2024  CBI...............  (G) Air pollutants  (G) Rare earth doped
                                                                      control parts in    zirconium oxide.
                                                                      automobiles.
P-24-0178...............         1   07/15/2024  Advancion.........  (G) Paints and      (S) 2-Butanol, 3-amino-
                                                                      coatings, home      3-methyl.
                                                                      and personal
                                                                      care, metal
                                                                      working fluids,
                                                                      electronics.
P-24-0183...............         1   07/25/2024  HPC Holdings, Inc.  (G) Chemical        (S) 1-Butanone, 4,4,4-
                                                                      intermediate.       trifluoro-3-hydroxyl-1-
                                                                                          (2-naphthalenyl)-3-
                                                                                          (trifluoromethyl)-.
SN-24-0007A.............         2   07/22/2024  CBI...............  (G) Additive for    (G) Inorganic acid,
                                                                      plastic,            metal salt, compd.
                                                                      Intermediate.       with substituted
                                                                                          aromatic heterocycle.
----------------------------------------------------------------------------------------------------------------

    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 7/01/2024 to 7/31/2024
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                                                                                   If amendment,  type of
                Case No.                    Received date    Commencement date            amendment                       Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-18-0172...............................         07/17/2024         08/28/2019  N...........................  (S) Calcium, carbonate 2-ethylhexanoate
                                                                                                               neodecanoate propionate complexes.
P-22-0005A..............................         07/22/2024         07/12/2024  N...........................  (S) Formic acid, compd. with 2-methyl-1,5-
                                                                                                               pentanediamine (2:1).
P-22-0083...............................         07/16/2024         07/04/2024  N...........................  (S) Oils, sandalwood, santalene synthase-
                                                                                                               modified Rhodobacter sphaeroides-
                                                                                                               fermented, from D-Glucose, oxidized.
P-22-0192...............................         06/27/2024         06/20/2024  N...........................  (G) Sulfonium, tricarbocyclic-, polyfluoro-
                                                                                                               heteroatom-substituted
                                                                                                               polycarbocyclicalkanesulfonate (1:1).
P-23-0124...............................         06/27/2024         06/20/2024  N...........................  (G) Sulfonium, tricabocyclic-, 2-
                                                                                                               heteroatom-substituted-
                                                                                                               (halocarbocyclic)carboxylate (1:1).
P-23-0126...............................         07/15/2024         07/08/2024  N...........................  (G) Alken-1-ol.
P-23-0135...............................         07/15/2024         07/08/2024  N...........................  (G) Alken-1-ol, 1-acetate.
P-23-0172...............................         06/27/2024         06/20/2024  N...........................  (G) Sulfonium, tricarbocyclic-,
                                                                                                               alkylcarbomocyclic-polyfluoro-
                                                                                                               heteropolycyclic-alkyl sulfonate (1:1),
                                                                                                               polymer with alkylaryl and
                                                                                                               carbomonocyclic alkylalkanoate, di-Me
                                                                                                               2,2'-(1,2-diazenediyl)bis(2-
                                                                                                               alkylalkanoate)-initiated.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 7/01/2024 to 7/31/2024
----------------------------------------------------------------------------------------------------------------
                                         Received
               Case No.                    date        Type of test information          Chemical substance
----------------------------------------------------------------------------------------------------------------
L-23-0173............................   07/09/2024  Algal Toxicity (OECD Test      (G) Cis-alkenoic acid.
                                                     Guideline 201).

[[Page 68902]]

 
P-14-0712............................   07/10/2024  Polychlorinated                (S) Waste plastics,
                                                     Dibenzodioxins and             pyrolyzed, C5-55 fraction.
                                                     Polychlorinated
                                                     dibenzofurans Testing.
P-18-0124............................   07/08/2024  90-Day Inhalation Toxicity     (S) Lithium nickel potassium
                                                     (OECD Test Guideline 413).     oxide.
P-21-0202, P-23-0104.................   07/23/2024  Determination of Dissociation  (G) Sulfonium, carbomonocycle
                                                     Constant (Conductometric       bis[(trihaloalkyl)carbomonoc
                                                     Method; OECD Guideline 112     ycle], substituted
                                                     OPPTS 830.7370).               carbomonocyclic ester; (G)
                                                                                    Sulfonium, carbomonocycle
                                                                                    bis[(trihaloalkyl)carbomonoc
                                                                                    ycle], disubstituted
                                                                                    carbomonocyclic ester.
P-24-0154............................   07/12/2024  Melting Point/Melting Range    (G) Polyphenyl, ethoxy-
                                                     (OECD Test Guideline 102);     polyfluoro-alkyl-.
                                                     Boiling Point/Boiling Range
                                                     (OECD Test Guideline 103);
                                                     Storage Stability (OECD Test
                                                     Guideline 113); Combined
                                                     Repeated Dose Toxicity with
                                                     the Reproduction/Development
                                                     Toxicity Screening Test
                                                     (OECD Test Guideline 422);
                                                     Particle Size, Fiber Length,
                                                     Diameter Distribution (OECD
                                                     Test Guideline 110); Density/
                                                     Relative Density/Bulk
                                                     Density (OECD Test Guideline
                                                     109); In Vitro Skin
                                                     Irritation Testing; Primary
                                                     Skin Irritation Testing in
                                                     Rabbits.
P-24-0154............................   07/12/2024  Acute Oral Toxicity (OECD      (G) Polyphenyl, ethoxy-
                                                     Test Guideline 423); Acute     polyfluoro-alkyl-.
                                                     Eye Irritation (OECD Test
                                                     Guideline 405); Bovine
                                                     Corneal Opacity and
                                                     Permeability Test Method for
                                                     Identifying i) Chemicals
                                                     Inducing Serious Eye Damage
                                                     and ii) Chemicals Not
                                                     Requiring Classification for
                                                     Eye Irritation or Serious
                                                     Eye Damage (OECD Test
                                                     Guideline 437); In Vitro
                                                     Mammalian Chromosome
                                                     Aberration Test (OECD Test
                                                     Guideline 473); Skin
                                                     Sensitization (OECD Test
                                                     Guideline 429); Flammability
                                                     Testing; Bacterial Reverse
                                                     Mutation Test (OECD Test
                                                     Guideline 471).
----------------------------------------------------------------------------------------------------------------

    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: August 22, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2024-19304 Filed 8-27-24; 8:45 am]
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