Notice2023-23471
Certain New Chemicals; Receipt and Status Information for September 2023
Primary source
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Published
October 24, 2023
Issuing agencies
Environmental Protection Agency
Abstract
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 9/1/ 2023 to 9/30/2023.
Full Text
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<title>Federal Register, Volume 88 Issue 204 (Tuesday, October 24, 2023)</title>
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[Federal Register Volume 88, Number 204 (Tuesday, October 24, 2023)]
[Notices]
[Pages 73013-73017]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-23471]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0061; FRL-10581-09-OCSPP]
Certain New Chemicals; Receipt and Status Information for
September 2023
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application (Biotech exemption); an
application for a test marketing exemption (TME), both pending and/or
concluded; a notice of commencement (NOC) of manufacture (including
import) for new chemical substances; and a periodic status report on
new chemical substances that are currently under EPA review or have
recently concluded review. This document covers the period from 9/1/
2023 to 9/30/2023.
DATES: Comments identified by the specific case number provided in this
document must be received on or before November 24, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0061, through the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#bfcdded7ded691d5d6d2ffdacfde91d8d0c9"><span class="__cf_email__" data-cfemail="3b495a535a52155152567b5e4b5a155c544d">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#4d191e0e0c60052239212423280d283d2c632a223b"><span class="__cf_email__" data-cfemail="abfff8e8ea86e3c4dfc7c2c5ceebcedbca85ccc4dd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
This document provides the receipt and status reports for the
period from 9/01/2023 to 9/30/2023. The Agency is providing notice of
receipt of PMNs,
[[Page 73014]]
SNUNs, and MCANs (including amended notices and test information); an
exemption application under 40 CFR part 725 (Biotech exemption); TMEs,
both pending and/or concluded; NOCs to manufacture a new chemical
substance; and a periodic status report on new chemical substances that
are currently under EPA review or have recently concluded review.
EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. 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: <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
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: <a href="https://www.epa.gov/chemicals-under-tsca">https://www.epa.gov/chemicals-under-tsca</a>.
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 <a href="http://regulations.gov">regulations.gov</a> 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 <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
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: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g. P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete
[[Page 73015]]
or invalid submissions. Note also that future versions of the following
tables may adjust slightly as the Agency works to automate population
of the data in the tables.
Table I--PMN/SNUN/MCANs Approved * From 09/01/2023 to 09/30/2023
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Case No. Version Received date Manufacturer Use Chemical substance
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J-23-0005.......... 1 08/30/2023 CBI.............. (G) Production of (G) Microorganisms
an enzyme. transformed to express and
enzyme.
J-23-0006.......... 1 08/30/2023 CBI.............. (G) Production of (G) Microorganisms
an enzyme. transformed to express and
enzyme.
P-21-0143A......... 4 09/25/2023 CBI.............. (G) Coating and (G) Aliphatic Diisocyanate,
adhesive homopolymer, aliphatic
ingredient. alcohol blocked.
P-21-0215A......... 2 09/01/2023 Coventya, Inc.... (S) The PMN (S) Pyridinium, 3-carboxy-1-
substance is methyl-, inner salt.
used in a
primarily
aqueous alkaline
electroplating
solution that
produces a
nominal zinc
(Zn) nickel (Ni)
alloy deposit on
iron bearing
substrates.
P-22-0011A......... 5 08/24/2023 Lord Corporation. (G) (G) Alkadiene, homopolymer,
Functionalized hydroxy-terminated, bis[N-
rubber in resin [2-[(1-oxo-2-propen-1-
side of two yl)oxylethyl]carbamates].
component epoxy
modified acrylic
adhesive.
P-22-0024A......... 3 09/25/2023 CBI.............. (G) Ingredient in (G) Amino salt, polymer
Industrial with 1,6-
Coating. diisocyanatohexane, oxime-
and glycol ether-blocked.
P-22-0043A......... 3 09/13/2023 CBI.............. (G) Intermediate. (G) Fatty acids,
hydroxyethoxy ethyl
esters.
P-22-0151A......... 7 08/28/2023 CBI.............. (G) Surfactant (G) Glycolipids, sophorose-
for commercial contg., yeast-fermented,
applications. from glycerides and
carbohydrates.
P-22-0157A......... 2 09/01/2023 Evonik (S) Polyurethane (S) 1,2-Ethanediamine,
Corporation. catalyst. N1,N2-dimethyl-N1-(1-
methylethyl)-N2-[2-
[methyl(1-
methylethyl)amino]ethyl]-.
P-22-0157A......... 3 09/07/2023 Evonik (S) Polyurethane (S) 1,2-Ethanediamine,
Corporation. catalyst. N1,N2-dimethyl-N1-(1-
methylethyl)-N2-[2-
[methyl(1-
methylethyl)amino]ethyl]-.
P-22-0168.......... 2 09/11/2023 Colonial (S) The product (G) Amides, alkyl, N-[3-
Chemical, Inc. is used as a (dimethylamino)propyl].
reaction
intermediate to
make surfactant
end-products. It
is not sold
commercially or
used outside of
our
manufacturing
facility.
P-22-0168A......... 3 09/25/2023 Colonial (S) The product (G) Amides, alkyl, N-[3-
Chemical, Inc. is used as a (dimethylamino)propyl].
reaction
intermediate to
make surfactant
end-products. It
is not sold
commercially or
used outside of
our
manufacturing
facility.
P-22-0175A......... 3 09/06/2023 Wacker Chemical (S) Polymer Resin (G) Modified
Corporation. Binder for Silsesquioxane, alkoxy-
composite stone terminated.
(Engineered
Stone).
P-23-0022A......... 2 09/08/2023 Cabot Corporation (G) Additive used (G) Multi-walled carbon
in industrial nanotubes.
applications.
P-23-0023A......... 2 09/08/2023 Cabot Corporation (G) Additive used (G) Multi-walled carbon
in industrial nanotubes.
applications.
P-23-0024A......... 2 09/08/2023 Cabot Corporation (G) Additive used (G) Multi-walled carbon
in industrial nanotubes.
applications.
P-23-0033A......... 2 09/08/2023 Cabot Corporation (G) Additive used (G) Multi-walled carbon
in industrial nanotubes.
applications.
P-23-0077A......... 3 08/31/2023 CBI.............. (G) Additive for (G) Alkanepolyoxy acid,
industrial alkyl substituted.
applications.
P-23-0077A......... 4 09/01/2023 CBI.............. (G) Additive for (G) Alkanepolyoxy acid,
industrial alkyl substituted.
applications.
P-23-0154A......... 3 09/20/2023 RWDC Industries.. (G) The primary (G) Vegetable oils,
application genetically modified
areas for PHA Cupriavidus-fermented,
are for food polyhydroxyalkanoate
packaging and copolymer.
other uses where
its
biodegradable
properties
provide
nontraditional
end-of-use
options.
[[Page 73016]]
P-23-0163.......... 2 09/06/2023 CBI.............. (G) Surface (S) 1,2-Ethanediamine, N1-
coating. [3-
(trimethoxysilyl)propyl]-,
hydrolysis products with 3-
(trimethoxysilyl)-N-[3-
(trimethoxysilyl)propyl]-1-
propanamine, nitrates
(salts).
P-23-0171.......... 2 09/06/2023 Interplastic (G) Polyester (S) 1,2,3-
Corporation. Resin Additive. Propanetricarboxylic acid,
2-hydroxy-, octyl ester.
P-23-0172A......... 2 09/13/2023 CBI.............. (G) (G) Sulfonium,
Photolithography. tricarbocyclic-,
alkylcarbomocyclic-
polyfluoro-
heteropolycyclic-alkyl
sulfonate (1:1), polymer
with alkylaryl and
carbomonocyclic alkyl
alkanoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-
alkylalkanoate]-initiated.
P-23-0175.......... 2 09/27/2023 CBI.............. (G) rinse (G)
material for Bis(fluoroalkylsubstituted
photolithography. ) sulfonyl sulfonamide.
P-23-0176.......... 1 09/06/2023 CBI.............. (G) An ingredient (G) Sulfonium, bis(dihalo
used in the carbomonocycle)carbomonocy
manufacture of cle-, salt with dihalo-
photoresist. sulfoalkyl trisubstituted
benzoate.
P-23-0177.......... 2 09/19/2023 Colonial (G) Corrosion (G) fatty acids, vegetable
Chemical, Inc. inhibitor. oil, reaction products
with diethylenetriamine.
P-23-0178.......... 1 09/07/2023 CBI.............. (S) Lens resins (S) Benzenamine, 4,4'-(9H-
for fluoren-9-ylidene)bis-.
photoelectric
conversion
adapters.
P-23-0179.......... 1 09/08/2023 CBI.............. (G) An ingredient (G) Sulfonium,
used in the bis(dihalocarbomonocycle)c
manufacture of arbomonocycle-, salt with
photoresist. substituted-
dihalobenzoate.
P-23-0181.......... 1 09/13/2023 CBI.............. (G) Used as (G) Alkanedioic acid,
adhesive. polymer with mixed
alkanediol, polyalkyl
glycol, carbomonocycle
carbomonocycle, alkane
carbopolycycle
diisocyanate.
P-23-0182.......... 1 09/15/2023 CBI.............. (G) Base oils in (G) Cyclic ether, polymer
lubricants. with 2-methyloxirane and
oxirane, monobutyl ether.
P-23-0183.......... 2 09/22/2023 CBI.............. (G) Additive in (G) Ethyl Modified Lactam.
paints, coatings
and inks, paint
removal
formulations,
wire coatings.
P-23-0184.......... 2 09/25/2023 CBI.............. (G) Intermediate. (G) Perfluorosulfonyl
fluoride polymer, with
perfluorodioxolane.
P-23-0185.......... 2 09/25/2023 CBI.............. (G) Intermediate. (G) Perfluorosulfonic acid
polymer, salt, with
perfluorodioxolane.
P-23-0186.......... 2 09/25/2023 CBI.............. (G) Dispersive (G) Perfluorosulfonic acid
Use. polymer, with
perfluorodioxolane.
P-23-0187.......... 1 09/21/2023 CBI.............. (S) Polymer for (G) Substituted
use in powder benzenedicarboxylic acid,
and tablet sodium salt, polymer with
laundry benzenedicarboxylic acids
detergent and 1,2-ethanediol.
formulations.
P-23-0188.......... 2 09/27/2023 CBI.............. (G) Destructive (G) Alkenoic acid, 3-methyl-
Use. , 1,1-dimethyl-2-propen-1-
yl ester; Alkenoic acid, 3-
methyl-, 1,1-dimethyl-2-
propen-1-yl ester;.
P-23-0189.......... 1 09/25/2023 CBI.............. (G) Component in (G)
polymers. Dimethanocarbopolycycle,
alkyl-polyhydro-.
P-23-0191.......... 1 09/25/2023 CBI.............. (G) (G) Sulfonium,
Photolithography. tricarbocyclic-,
heteroatom-substituted-
(halocarbocyclic)carboxyla
te (1:1).
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In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
that have passed an initial screening by EPA during this period: The
EPA case number assigned to the NOC including whether the submission
was an initial or amended submission, the date the NOC was received by
EPA, the date of commencement provided by the submitter in the NOC, a
notation of the type of amendment (e.g., amendment to generic name,
specific name, technical contact information, etc.) and chemical
substance identity.
Table II--NOCs Approved * From 09/01/2023 to 09/30/2023
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If amendment, type of
Case No. Received date Commencement date amendment Chemical substance
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J-22-0023............... 09/28/2023 09/15/2023 N (G) Microorganisms stably
transformed to manufacture
PHA.
J-22-0024............... 09/29/2023 09/20/2023 N (G) Microorganisms stably
transformed to manufacture
PHA.
[[Page 73017]]
J-22-0025............... 09/29/2023 09/29/2023 N (G) Microorganisms stably
transformed to manufacture
PHA.
J-23-0004............... 09/18/2023 09/11/2023 N (G) Genetically modified
microorganism.
P-21-0073............... 09/25/2023 09/07/2023 N (S) 4-
cyclohexanedicarboxylic
acid, 1,4-dinonyl ester,
branched and linear.
P-21-0175............... 09/29/2023 09/22/2023 N (G) Polycarbonate diol/
benebiol nldb grade.
P-97-0954A.............. 09/21/2023 10/23/2020 Amended generic (G) Isocyanic acid,
chemical name. polymethylenepolyphenylene
ester, polymer with
.alpha.,.alpha.'-[(1-
methylethylidene)di-4,1-
phenylene]bis[.omega.-
hydroxypoly(oxyalkanediyl)
] and 1,2-alkanediol, 2-
alkoxyethanol-blocked.
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* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
information and documents have been provided with the submission.
In Table III of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information that has been received during this time period: The
EPA case number assigned to the test information; the date the test
information was received by EPA, the type of test information
submitted, and chemical substance identity.
Table III--Test Information Received From 09/01/2023 to 09/30/2023
------------------------------------------------------------------------
Type of test Chemical
Case No. Received date information substance
------------------------------------------------------------------------
P-16-0543......... 09/01/2023 Exposure (G)
Monitoring Halogenophosphor
Report. ic acid metal
salt.
P-16-0543......... 09/01/2023 Exposure (G)
Monitoring Halogenophosphor
Report. ic acid metal
salt.
P-18-0304......... 09/06/2023 Partition (G) Sulfonium,
Coefficient (n- bis(dihalocarbom
octanol/water), onocycle)
Shake Flask carbomonocycle,
Method (OECD salt with
Test Guideline substituted
107); Partition heteropolycycle
Coefficient (n- dihalo
octanol/water), sulfoalkanoate
Estimation by (1:1).
Liquid
Chromatography
(OECD Test
Guideline 117).
P-22-0046......... 09/01/2023 Published Studies (S) Fibroins.
on Allergenicity.
P-22-0128......... 09/20/2023 Mass (G) Alkyl
Spectrometry, IR cycloalkane,
Spectrometry, polyfluoro-.
NMR Testing Data.
------------------------------------------------------------------------
If you are interested in information that is not included in these
tables, you may contact EPA's technical information contact or general
information contact as described under FOR FURTHER INFORMATION CONTACT
to access additional non-CBI information that may be available.
Authority: 15 U.S.C. 2601 et seq.
Dated: October 18, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2023-23471 Filed 10-23-23; 8:45 am]
BILLING CODE 6560-50-P
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