[Federal Register Volume 88, Number 137 (Wednesday, July 19, 2023)]
[Notices]
[Pages 46157-46160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15301]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0061; FRL-10581-06-OCSPP]


Certain New Chemicals; Receipt and Status Information for June 
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 6/1/
2023 to 6/30/2023.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before August 18, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2023-0061, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting and visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Jim Rahai, Project Management 
and Operations Division (MC 7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-8593; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the 
period from 6/01/2023 to 6/30/2023. 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

[[Page 46158]]

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 06/01/2023 to 06/30/2023
----------------------------------------------------------------------------------------------------------------
       Case No.         Version   Received date      Manufacturer               Use           Chemical substance
----------------------------------------------------------------------------------------------------------------
P-21-0016A...........         4      05/25/2023  CBI.................  (G) Paint additive,   (G) Alkanoic acid,
                                                                        Additive in coating   dialkyl ester.
                                                                        formulations,
                                                                        Component in
                                                                        cleaning agents.
P-21-0016A...........         5      06/19/2023  CBI.................  (G) Paint additive,   (G) Alkanoic acid,
                                                                        Additive in coating   dialkyl ester.
                                                                        formulations,
                                                                        Component in
                                                                        cleaning agents.
P-21-0021A...........         7      05/25/2023  J6 Polymers.........  (S) Raw material to   (S) Soybean oil,
                                                                        be blending into R-   mixed esters with
                                                                        side components of    diethylene glycol,
                                                                        the polyurethane      phthalic acid and
                                                                        and                   terephthalic acid.
                                                                        polyisocyanurate
                                                                        industry.
                                                                        Specifically used
                                                                        in slabstock/
                                                                        bunstock processing
                                                                        of foam.
P-22-0071A...........         5      06/06/2023  CBI.................  (G) Industrial        (S) D-
                                                                        Surfactant.           Glucopyranose,
                                                                                              oligomeric,
                                                                                              maleates, C9-11-
                                                                                              alkyl glycosides,
                                                                                              sulfonated,
                                                                                              potassium salts.
P-22-0072A...........         5      06/06/2023  CBI.................  (G) Industrial        (S) D-
                                                                        Surfactant.           Glucopyranose,
                                                                                              oligomeric,
                                                                                              maleates, decyl
                                                                                              octyl glycosides,
                                                                                              sulfonated,
                                                                                              potassium salts.
P-22-0073A...........         5      06/06/2023  CBI.................  (G) Industrial        (S) D-
                                                                        Surfactant.           Glucopyranose,
                                                                                              oligomeric,
                                                                                              maleates, C10-16-
                                                                                              alkyl glycosides,
                                                                                              sulfonated,
                                                                                              potassium salts.
P-22-0125A...........         4      06/05/2023  CBI.................  (G) Corrosion         (G)
                                                                        inhibitor.            Isononanoylamidoca
                                                                                              proic Acid.
P-22-0125A...........         5      06/22/2023  CBI.................  (G) Corrosion         (G)
                                                                        inhibitor.            Isononanoylamidoca
                                                                                              proic Acid.

[[Page 46159]]

 
P-22-0140A...........         3      06/07/2023  CBI.................  (G) Corrosion         (G) 6-[(alkyl-1-
                                                                        inhibitor.            oxohexyl)amino]-
                                                                                              hexanoic acid,
                                                                                              compd. with
                                                                                              cyclohexylamine
                                                                                              (1:1).
P-23-0013A...........         2      06/26/2023  Honeycomb Techno      (S) Epoxy molding     (S) Phenol, polymer
                                                  Research USA, Inc.    compound for          with 4,4'-
                                                                        electronic device.    bis(chloromethyl)-
                                                                                              1,1'-biphenyl.
P-23-0064A...........         3      06/20/2023  CBI.................  (G) Component in      (G) Alkanediol,
                                                                        aerospace coatings.   substituted,
                                                                                              polymer with
                                                                                              diisocyanatoalkane
                                                                                              , substituted
                                                                                              heterocycle-
                                                                                              modified.
P-23-0066A...........         3      06/01/2023  CBI.................  (G) An antioxidant    (G) Alkylated
                                                                        additive.             phenyl-naphthalene
                                                                                              amine.
P-23-0066A...........         4      06/13/2023  CBI.................  (G) An antioxidant    (G) Alkylated
                                                                        additive.             phenyl-naphthalene
                                                                                              amine.
P-23-0066A...........         5      06/26/2023  CBI.................  (G) An antioxidant    (G) Alkylated
                                                                        additive.             phenyl-naphthalene
                                                                                              amine.
P-23-0142............         1      05/30/2023  CBI.................  (G) Destructive Use.  (G) Alkenal, 9-
                                                                                              (acetyloxy)-, (E)-
                                                                                              .
P-23-0143............         1      06/13/2023  Sika Corporation....  (S) Retarder for use  (S) L-Lysine, N-(3-
                                                                        in gypsum-based       carboxy-1-
                                                                        construction          oxopropyl)
                                                                        materials.            derivs., sodium
                                                                                              salts.
P-23-0144............         1      06/13/2023  Sika Corporation....  (S) Retarder for use  (S) L-Lysine, N-(3-
                                                                        in gypsum-based       carboxy-1-
                                                                        construction          oxopropyl)
                                                                        materials.            derivs., calcium
                                                                                              salts.
P-23-0145............         1      06/14/2023  Engineered Bonded     (S) Talathol PO3,     (G) Polyethylene
                                                  Structures and        the material for      terephthalate
                                                  Composites.           which this notice     polyol.
                                                                        is filed, is
                                                                        intended to be used
                                                                        as a copolymer in
                                                                        the production of
                                                                        urethane foam or
                                                                        coating.
P-23-0147............         1      06/16/2023  CBI.................  (G) Photolithography  (G) Sulfonium,
                                                                                              tris(heteroatom-
                                                                                              substituted
                                                                                              carbomonocyclic),
                                                                                              salt with
                                                                                              polyhydro-
                                                                                              polyfluoro-
                                                                                              heteroatom-
                                                                                              substituted alkyl
                                                                                              heteropolycyclic-
                                                                                              heteroatom-
                                                                                              substituted aryl
                                                                                              heteroatom-
                                                                                              substituted
                                                                                              benzoate (1:1).
P-23-0151............         2      06/28/2023  CBI.................  (G) Oil production..  (G) Amides, from
                                                                                              polyalkylamine,
                                                                                              dioic acid
                                                                                              anhydride and
                                                                                              alkyl fatty acids.
P-23-0152............         1      06/28/2023  CBI.................  (G) CMP slurry......  (G) 1-Alkanethiol,
                                                                                              3-(trialkoxysilyl)-
                                                                                               hydrolysis
                                                                                              products with
                                                                                              silica, oxidized.
SN-23-0024...........         1      06/27/2023  CBI.................  (G) Component in      (S) Phosphoric
                                                                        batteries.            acid, iron(2+)
                                                                                              lithium salt
                                                                                              (1:1:1).
----------------------------------------------------------------------------------------------------------------

    In Table II of this unit, EPA provides the following information 
(to the extent that such information is not claimed as CBI) on the NOCs 
that have passed an initial screening by EPA during this period: The 
EPA case number assigned to the NOC including whether the submission 
was an initial or amended submission, the date the NOC was received by 
EPA, the date of commencement provided by the submitter in the NOC, a 
notation of the type of amendment (e.g., amendment to generic name, 
specific name, technical contact information, etc.) and chemical 
substance identity.

                             Table II--NOCs Approved * From 06/01/2023 to 06/30/2023
----------------------------------------------------------------------------------------------------------------
                                          Commencement    If amendment, type of
        Case No.          Received date       date              amendment               Chemical substance
----------------------------------------------------------------------------------------------------------------
J-22-0019..............      06/23/2023      06/18/2023  N                       (G) Saccharomyces cerevisiae,
                                                                                  strain CBI.
J-22-0020..............      06/23/2023      06/18/2023  N                       (G) Saccharomyces cerevisiae,
                                                                                  strain CBI.
P-16-0167..............      06/23/2023      06/06/2023  N                       (S) Fatty acids, c12-20, 1, 2,
                                                                                  2, 6, 6-pentamethyl-4-
                                                                                  piperidinyl esters.
P-20-0044..............      06/26/2023      06/25/2023  N                       (S) 1-propanamine, 3-methoxy-
                                                                                  n,n-dimethyl-.
P-20-0076..............      06/02/2023      05/17/2023  N                       (S) Glycine, reaction products
                                                                                  with sodium o-iso-pr
                                                                                  carbonodithioate, sodium
                                                                                  salts.
P-20-0130..............      06/09/2023      05/26/2023  N                       (S) Carbonic acid, diphenyl
                                                                                  ester, polymer with 1,10-
                                                                                  decanediol, 1,12-dodecanediol,
                                                                                  1,6-hexanediol and 1,1'-
                                                                                  methylenebis[4-
                                                                                  isocyanatobenzene.
P-21-0109..............      06/29/2023      05/29/2023  N                       (S) Naphtha (glyceridic), light
                                                                                  alkylate.
P-21-0110..............      06/29/2023      05/29/2023  N                       (S) Naphtha (glyceridic), light
                                                                                  catalytic cracked.
P-21-0111..............      06/29/2023      05/29/2023  N                       (S) Naphtha (glyceridic), heavy
                                                                                  catalytic cracked.
P-21-0112..............      06/29/2023      05/29/2023  N                       (S) Naphtha (glyceridic), light
                                                                                  hydrocracked.
P-21-0113..............      06/29/2023      05/29/2023  N                       (S) Naphtha (glyceridic),
                                                                                  isomerization.
P-21-0114..............      06/29/2023      05/29/2023  N                       (S) Naphtha (glyceridic), heavy
                                                                                  catalytic reformed.
P-21-0116..............      06/29/2023      05/29/2023  N                       (S) Distillates (glyceridic),
                                                                                  hydrotreated light.
P-21-0117..............      06/29/2023      05/29/2023  N                       (S) Distillates (glyceridic),
                                                                                  hydrotreated light paraffinic.

[[Page 46160]]

 
P-21-0118..............      06/29/2023      05/29/2023  N                       (S) Distillates (glyceridic),
                                                                                  light catalytic cracked.
P-21-0119..............      06/29/2023      05/29/2023  N                       (S) Distillates (glyceridic),
                                                                                  heavy hydrocracked.
P-21-0121..............      06/28/2023      05/29/2023  N                       (S) Distillates (glyceridic),
                                                                                  heavy catalytic cracked.
P-21-0122..............      06/29/2023      05/29/2023  N                       (S) Naphtha (glyceridic), heavy
                                                                                  hydrocracked.
P-21-0123..............      06/29/2023      05/29/2023  N                       (S) Distillates (glyceridic),
                                                                                  light hydrocracked.
P-21-0126..............      06/14/2023      06/13/2023  N                       (G) Substituted
                                                                                  heteromonocycle, polymer with
                                                                                  haloalkyl substituted
                                                                                  heteromonocycle, dialkyl-
                                                                                  alkanediamine,
                                                                                  (alkylalkylidene)bis[hydroxyca
                                                                                  rbomonocycle] and
                                                                                  oxybis[alkanol], reaction
                                                                                  products with metal oxide and
                                                                                  dialkanolamine.
P-22-0051..............      06/23/2023      05/31/2023  N                       (S) 2,5-furandione, dihydro-,
                                                                                  monopolyisobutylene derivs.,
                                                                                  reaction products with
                                                                                  tetraethylenepentamine.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission.

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

   Table III--Test Information Received From 06/01/2023 to 06/30/2023
------------------------------------------------------------------------
                                       Type of test         Chemical
     Case No.        Received date     information         substance
------------------------------------------------------------------------
P-14-0712.........      06/13/2023  Polychlorinated    (S) Waste
                                     Dibenzodioxins     plastics,
                                     and                pyrolyzed, C5-55
                                     Polychlorinated    fraction.
                                     dibenzofurans
                                     Testing.
P-14-0712.........      06/07/2023  Polychlorinated    (S) Waste
                                     Dibenzodioxins     plastics,
                                     and                pyrolyzed, C5-55
                                     Polychlorinated    fraction.
                                     dibenzofurans
                                     Testing.
P-16-0543.........      06/20/2023  Exposure           (G)
                                     Monitoring         Halogenophosphor
                                     Report.            ic acid metal
                                                        salt.
P-16-0543.........      06/06/2023  Exposure           (G)
                                     Monitoring         Halogenophosphor
                                     Report.            ic acid metal
                                                        salt.
P-22-0167.........      06/23/2023  72 hour & 96 hour  (G) 1,2-
                                     Freshwater Algae   cycloalkanedicar
                                     Exposure Testing.  boxylic acid,
                                                        1,2-bis(2-
                                                        oxiranylalkyl)
                                                        ester, reaction
                                                        products with
                                                        unsaturated
                                                        carboxylic acid.
------------------------------------------------------------------------

    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: July 13, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2023-15301 Filed 7-18-23; 8:45 am]
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