Notice2022-25743
Certain New Chemicals; Receipt and Status Information for October 2022
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Published
November 25, 2022
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 10/1/ 2022 to 10/31/2022.
Full Text
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<title>Federal Register, Volume 87 Issue 226 (Friday, November 25, 2022)</title>
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[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Notices]
[Pages 72475-72479]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25743]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0132; FRL-9411-10-OCSPP]
Certain New Chemicals; Receipt and Status Information for October
2022
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 10/1/
2022 to 10/31/2022.
DATES: Comments identified by the specific case number provided in this
document must be received on or before December 27, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2022-0132, 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#2250434a434b0c484b4f624752430c454d54"><span class="__cf_email__" data-cfemail="7103101910185f1b181c311401105f161e07">[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#6531362624482d0a11090c0b00250015044b020a13"><span class="__cf_email__" data-cfemail="3561667674187d5a41595c5b50755045541b525a43">[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 10/01/2022 to 10/31/2022. 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
[[Page 72476]]
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 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.
[[Page 72477]]
Table I--PMN/SNUN/MCANs Approved * From 10/1/2022 to 10/31/2022
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Received
Case No. Version date Manufacturer Use Chemical substance
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J-22-0019............. 2 10/3/2022 CBI................ (G) Production of a (G) Saccharomyces
chemical. cerevisiae, chromosomal
integration
modification.
J-22-0020............. 2 10/3/2022 CBI................ (G) Production of a (G) Saccharomyces
chemical. cerevisiae, chromosomal
integration
modification.
J-22-0022............. 1 9/23/2022 RWDC Industries.... (G) Production of (G) Microorganisms
PHA. stably transformed to
manufacture PHA.
J-22-0023............. 1 9/23/2022 RWDC Industries.... (G) Production of (G) Microorganisms
PHA. stably transformed to
manufacture PHA.
J-22-0024............. 1 9/23/2022 RWDC Industries.... (G) Production of (G) Microorganisms
PHA. stably transformed to
manufacture PHA.
J-22-0025............. 1 9/23/2022 RWDC Industries.... (G) Production of (G) Microorganisms
PHA. stably transformed to
manufacture PHA.
P-16-0512A............ 5 9/30/2022 CBI................ (S) Component of a (G) Fatty acid dimers,
UV curable polymer with acrylic
printing inks. acid and
pentaerythritol
reaction products.
P-17-0194A............ 2 10/20/2022 CBI................ (G) Pigment (G) Hydrogenated dihalo
additive for dialkyl
industrial diindolotriphenodioxazi
coatings. ne,
dihydrodisubstituted
isoindolyl alkyl
derivs.
P-18-0070A............ 11 10/24/2022 Arrowstar, LLC..... (G) Chemical (G) Waste plastics,
intermediate for polyester, depolymd.
polyurethane with glycols, polymers
industry. with dicarboxylic
acids.
P-20-0060A............ 6 10/6/2022 CBI................ (S) Solvent-based (G) Bismuth Carboxylate
pigmented one- and complexes.
two-component
polyurethane
coatings
Automotive
Refinish General
Industrial Coil.
P-20-0060A............ 8 10/20/2022 CBI................ (S) Catalyst for (G) Bismuth Carboxylate
polyurethane foam complexes.
manufacturing.
P-22-0080A............ 4 10/7/2022 Huntsman (S) As an (S) Poly(oxy-1,2-
International LLC. industrial ethanediyl), ,'-
intermediate used (iminodi-2,1-
in the manufacture ethanediyl)bis[-(2-
of polyamides as a aminoethoxy)-;(S)
monomer. Poly(oxy-1,2-
ethanediyl), -(2-
aminoethyl)-(2-
aminoethoxy)-;.
P-22-0121A............ 3 10/4/2022 CBI................ (G) Process (G) polychloroalkene.
Intermediate: New
chemical substance
will be used as a
process
intermediate.
P-22-0148A............ 3 10/27/2022 CBI................ (G) Intermediate... (G) Substituted
benzonitrile.
P-22-0153A............ 3 10/6/2022 Huntsman (S) Notified (S) 2-Propenoic acid, 2-
International LLC. substance will be methyl-, 2-hydroxyethyl
used as an ester, reaction
adhesion promoter products with 2-
in a resin used oxepanone homopolymer 2-
for adhesive and/ [(2-methyl-1-oxo-2-
or sealants in propen-1-yl)oxy]ethyl]
industrial ester and phosphorous
assembly or oxide (P2O5).
manufacturing
operations, in
outdoor repair.
Through small
scale application
on assembly line,
manual use, or
automated use by
dispensing unit.
P-22-0175............. 2 10/26/2022 Wacker Chemical (S) Polymer Resin (G) Modified
Corporation. Binder for Silsesquioxane, alkoxy-
composite stone terminated.
(Engineered Stone).
P-22-0187............. 2 9/29/2022 LG Energy Solution (G) Substance for (G) Mixed metal oxide.
Michigan Inc. use in the
manufacture of
battery components.
P-22-0192............. 2 10/11/2022 CBI................ (G) (G) Sulfonium,
Photolithography. tricarbocyclic-,
polyfluoro-heteroatom-
substituted
polycarbocyclicalkanesu
lfonate (1:1).
P-23-0001............. 1 10/3/2022 Solugen Inc........ (G) Additive for (G) Polycarboxylic acid,
consumer, salt.
commercial, and
industrial
applications.
P-23-0002............. 1 10/3/2022 Solugen Inc........ (G) Additive for (G) Polycarboxylic acid,
consumer, salt.
commercial, and
industrial
applications.
P-23-0003............. 1 10/3/2022 Solugen Inc........ (G) Additive for (G) Polycarboxylic acid,
consumer, salt.
commercial, and
industrial
applications.
P-23-0004............. 1 10/3/2022 Solugen Inc........ (G) Additive for (G) Polycarboxylic acid,
consumer, salt.
commercial, and
industrial
applications.
P-23-0005............. 1 10/3/2022 Solugen Inc........ (G) Additive for (G) Polycarboxylic acid,
consumer, salt.
commercial, and
industrial
applications.
P-23-0006............. 2 10/13/2022 Siltech Inc........ (G) additive....... (S) Siloxanes and
silicones, di-Me, Me
hydrogen, reaction
products with vinyl
group-terminated di-Me
siloxanes.
P-23-0009............. 1 10/5/2022 Givaudan Fragrances (G) Fragrance (G) Cysteine, cyclic
Corp. ingredient for use alkyl, ethyl ester.
in laundry
applications.
P-23-0010............. 1 10/5/2022 Givaudan Fragrances (G) Fragrance (G) Alkylthio ketone.
Corp. ingredient for use
in laundry
applications.
P-23-0011............. 1 10/10/2022 CBI................ (G) Cross-linking (G)
agent. divinylperfluoroalkane.
P-23-0012............. 1 10/11/2022 CBI................ (S) Polymer for use (G) Starch, polymer with
in concrete alkenoic acid, salt.
applications.
P-23-0013............. 1 10/12/2022 Honeycomb Techno (S) Epoxy molding (S) Phenol, polymer with
Research USA Inc. compound for 4,4'-bis(chloromethyl)-
electronic device. 1,1'-biphenyl.
P-23-0015............. 1 10/26/2022 CBI................ (G) Water treatment (G) Amines,
chemical. polyalkylenepoly,
(disubstitutedcarboxy)
derivs., alkali metal
salts.
P-23-0016............. 1 10/26/2022 Kuraray America, (G) Additive for (S) 2-Propanol, 1,3-
Inc. paints, UV inks, bis[(3-methyl-2-buten-1-
coatings, etc. yl)oxy]-.
SN-21-0003A........... 4 10/26/2022 Norquay Technology (G) Intermediate... (S) 1,1'-Biphenyl, 4,4'-
Inc. dibromo-.
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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 prior to the start of the 90 day review
period, and in no way reflects the final status of a complete submission review.
[[Page 72478]]
In Table II. of this unit, EPA provides the following information
(to the extent that such information is not subject to a CBI claim) on
the TMEs and/or Biotech Exemptions received by EPA during this period:
The EPA case number assigned to the TME and/or Biotech Exemption, the
submission document type (initial or amended), the version number, the
date the TME and/or Biotech Exemption was received by EPA, the
submitting manufacturer (i.e., domestic producer or importer), the
potential uses identified by the manufacturer in the TME and/or Biotech
Exemption, and the chemical substance identity.
Table II--TMEs and Biotech Exemptions Received From 10/1/2022 to 10/31/2022
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Case No. Submission type Version Received date Manufacturer Use Chemical substance
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T-22-0001A............. Test Marketing 3 10/4/2022 CBI.................... (G) Functional (G) Mica-group minerals,
Exemption mineral in reaction products with
Application (TMEA). automotive triethoxysilyl
components, and substituted-alkane.
mineral for
plastics.
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In Table III 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 III--NOCs Approved * From 10/1/2022 to 10/31/2022
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If amendment, type of
Case No. Received date Commencement date amendment Chemical substance
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P-12-0346................ 10/20/2022 10/17/2022 N..................... (S) 2-propanone, 2,2',2``-
[o,o',o''-
(ethylsilylidyne)trioxime
].
P-15-0691A............... 10/7/2022 7/22/2022 Amended generic (G) Polyamidoamine n-
chemical name. carbodithioate, sodium
salt.
P-18-0282A............... 10/25/2022 10/6/2021 Amended generic (G) Fatty acid ester,
chemical name. polyether,
poly[di(ethylene glycol)
adipate], methylene
diphenyl diisocyanate.
P-21-0023................ 10/5/2022 9/7/2022 N..................... (G) Sulfonium, carbocyclic-
, salt with 1-(alkyl) 2-
[4-[polyhydro-2-
carbomonocyclic-5-
(polyfluoro-2-sulfoalkyl)-
4,7-methano-1,3-
benzodioxol-2-
yl]carbomonocyclic
oxy]acetate (1:1).
P-21-0068................ 10/6/2022 9/8/2022 N..................... (G) Metalloxanes, alkyl,
alkyl group-terminated,
reaction products with
dihalo-dialkylalkylaryl-
alkyl-polycyclic-
ylidene(dialkylsilylene)-
dialkylalkylarylalkylalky
l-polycyclic-ylidene,
metal oxide and
nonmetallic oxide.
P-21-0085................ 10/11/2022 9/15/2022 N..................... (S) 1-propanethiol, 3-
(triethoxysilyl)-,
reaction products with
polybutadiene.
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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 IV 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 IV--Test Information Received From 10/1/2022 to 10/31/2022
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0543............................... 10/14/2022 Industrial Hygiene (G) Halogenophosphoric
Exposure Report. acid metal salt.
P-21-0011............................... 10/14/2022 Test Scheduling (G) Hexane, 1,6-
Notification. diisocyanato-,
homopolymer, alkyl epoxy
ether- and polyethylene
glycol mono-me ether-
blocked, reaction
products with
propylenimine.
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[[Page 72479]]
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: November 21, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2022-25743 Filed 11-23-22; 8:45 am]
BILLING CODE 6560-50-P
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