Notice2023-00859
Certain New Chemicals; Receipt and Status Information for December 2022
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 18, 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 12/1/ 2022 to 12/31/2022.
Full Text
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<title>Federal Register, Volume 88 Issue 11 (Wednesday, January 18, 2023)</title>
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[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2912-2916]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00859]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0132; FRL-9411-12-OCSPP]
Certain New Chemicals; Receipt and Status Information for
December 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 12/1/
2022 to 12/31/2022.
DATES: Comments identified by the specific case number provided in this
document must be received on or before February 17, 2023.
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="1c6e7d747d75327675715c796c7d327b736a">[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#16424555573b5e79627a7f78735673667738717960"><span class="__cf_email__" data-cfemail="42161101036f0a2d362e2b2c27022732236c252d34">[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 12/01/2022 to 12/31/2022. 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 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
[[Page 2913]]
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 version of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.
[[Page 2914]]
Table I--PMN/SNUN/MCANs Approved * From 12/1/2022 to 12/31/2022
----------------------------------------------------------------------------------------------------------------
Case No. Version Received date Manufacturer Use Chemical substance
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P-18-0146A............ 4 12/19/2022 CBI................ (G) Primer paint (G) Modified fat
binders for open amines, polymers
non-dispersive with bisphenol A,
uses. alkanolamines,
epichlorohydrin,
alkylamine and
substituted
isocyanato
[isocyanatoalkylca
rbomonocyle].
P-22-0002A............ 4 12/01/2022 Materion Advanced (G) This product is (G) Metal Oxide
Chemicals. used for the Chloride.
manufacturing of
electronic devices.
P-22-0095A............ 2 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates.
P-22-0096A............ 2 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates.
P-22-0097A............ 2 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates.
P-22-0098A............ 2 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates.
P-22-0099A............ 2 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates.
P-22-0100A............ 2 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates.
P-22-0101A............ 3 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0102A............ 3 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0103A............ 3 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0104A............ 3 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0105A............ 3 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0106A............ 3 12/05/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0119A............ 3 12/12/2022 CBI................ (G) Resin for (G)
packaging and Polyhydroxyalkanoa
Binding agent. te.
P-22-0120A............ 3 12/12/2022 CBI................ (G) Resin for (G)
packaging, Binder Polyhydroxyalkanoa
materials. te.
P-23-0009A............ 2 12/19/2022 CBI................ (G) Fragrance (G) Cysteine,
ingredient for use cyclic alkyl,
in laundry ethyl ester.
applications..
P-23-0014A............ 5 12/12/2022 CBI................ (S) Intermediate in (G) [Polyalkyl-
production of methylenepolyhydro-
fragrance. polycyclic]alkyl
acetate.
P-23-0028............. 3 12/13/2022 CBI................ (S) Encapsulating (G) gelatin and
Shell Polymer for maltodextrin
Fragrance crosslinked with
Encapsulates for linear and cyclic
Industrial or aliphatic
Household Consumer polyisocyanates.
Products such as
Detergents and
Fabric Softeners.
P-23-0029A............ 2 12/07/2022 CBI................ (G) Battery Cathode (G) Cobalt metal
Manufacturing. nickel oxide.
P-23-0035............. 2 12/13/2022 CBI................ (G) Isolated (G) Aryl alkoxy
intermediate. ether.
P-23-0036............. 1 11/30/2022 Elantas PDG, Inc... (S) MF8044 Resin is (S) Castor oil,
an unsaturated polymer with
polyester resin dicyclopentadiene,
used in an maleic anhydride,
electrical 2-methyl-1,3-
insulation propanediol,
coating. The 3a,4,7,7a-
coating is used to tetrahydro-2-(2-
insulate hydroxyethyl)-1H-
electrical isoindole-1,3(2H)-
components in dione and
automobiles. triethylene
glycol.
P-23-0037............. 1 12/01/2022 CBI................ (G) Photoacid (G) Monoaromatic
generator (PAG) cyclic alkylene
for use in sulfonium
electronics fluoroalkyl
industry. sulfonic acid
salt.
P-23-0038............. 2 12/07/2022 Allnex, USA Inc.... (S) Crosslinker (G) Formaldehyde,
(hardener) for polymer with
various water phenol,
dilutable backbone carboxyalkyl
binders (e.g., ethers, alkali
polyester resins, salts, compds.
epoxy resins or with
acrylic resins) in (dialkylamino)alka
order to obtain nol.
high chemical
resistant
protective layers
for heat curing
metal application.
P-23-0039............. 2 12/19/2022 Evonik Corporation. (S) Surfactant in (G) Rhamnolipids,
manual/hand dish modified
detergent, surface pseudomonas-
cleaner, laundry fermented, from
detergent. dextrose, salts.
P-23-0040............. 2 12/19/2022 Evonik Corporation. (S) Surfactant in (G) Rhamnolipids,
manual/hand dish modified
detergent, surface pseudomonas-
cleaner, laundry fermented, from
detergent. dextrose, salts.
[[Page 2915]]
P-23-0041............. 1 12/09/2022 CHT USA Inc........ (G) Additive into (G) Siloxane &
consumer cleaning Silicone, alkyl
products, amino polymer.
Industrial &
Institutional
Cleaners.
P-23-0042............. 1 12/12/2022 Clariant (S) Intermediate (G) Oxirane, alkyl-
Corporation. for use in , polymer with
producing polymers. oxirane,
monoethers with
polyethylene
glycol alkenyl
ether.
P-23-0043............. 1 12/12/2022 Clariant (S) Intermediate (G) Oxirane, alkyl-
Corporation. for use in , polymer with
producing polymers. oxirane, sulfate,
ethers with
polyethylene
glycol alkenyl
ether, salt.
P-23-0044............. 1 12/13/2022 CBI................ (G) Photoacid (G) Monoaromatic
generator (PAG) cyclic alkylene
for use in sulfonium
electronics fluoroalkyl
industry. sulfonic acid
salt.
P-23-0046............. 1 12/16/2022 CBI................ (G) Process aid for (G) Siloxanes and
the fabrication of Silicones, di-
molded articles. alkyl, hydroxy-
terminated,
polymers with
substituted alkane
and substituted
silane.
P-23-0047............. 1 12/16/2022 CBI................ (G) Additive in (G)
plating baths. Heteromonocyclic,
dialkyl amide,
substituted alkyl
salt.
P-23-0048............. 2 12/19/2022 Dynax Corporation.. (G) Additive used (G) Alkenoic acid,
in industrial and reaction products
commercial with
applications. polyalkenimine,
poly-mercapto
alkanolester and
C6-fluoro
haloalkane,
compds. with
alkanolamine.
P-23-0049............. 1 12/21/2022 CBI................ (G) (G) Sulfonium,
Photolithography. tricarbocyclic-, 2-
aryl-
polyfluoropolyhydr
o-alkano -
heteropolycycle-
alkanesulfonate
(1:1), polymer
with heteroatom
substituted aryl
and
carbomonocyclic 2-
alkyl-2-alkanoate,
di-Me 2,2-(1,2-
diazenediyl)bis[2-
methylpropanoate]-
initiated.
P-23-0050............. 1 12/23/2022 SHIN-ETSU Microsi.. (G) Contained use (G)
for Substitutedheteroc
microlithography yclic onium
for electronic compound, salt
device with
manufacturing. heteropolysubstitu
tedalkyl
substitutedtricycl
oalkanecarboxylate
(1:1), polymer
with 3-
ethenylphenol and
heterosubstituteda
romaticalkyl 2-
methyl-2-
propenoate, di-Me
2,2'-(1,2-
diazenediyl)bis[2-
methylpropanoate]-
initiated.
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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 12/1/2022 to 12/31/2022
----------------------------------------------------------------------------------------------------------------
If amendment, type of
Case No. Received date Commencement date amendment Chemical substance
----------------------------------------------------------------------------------------------------------------
P-11-0224A................ 12/06/2022 08/29/2022 Amended generic (G) Propane, fluoro-
chemical name. substituted-3-(1,1,2,2-
tetrafluoroethoxy)-.
P-21-0019................. 11/30/2022 11/28/2022 N.................... (G) Ethyl 4-alkyl-2-
oxocycloalkanecarboxylate
.
----------------------------------------------------------------------------------------------------------------
* 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 12/1/2022 to 12/31/2022
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-13-0021...................... 12/05/2022 Revised Test Data Validation (G) Perfluoroacrylate polymer.
Study.
P-14-0712...................... 11/30/2022 Polychlorinated Dibenzodioxins (G) Plastics, wastes,
and Polychlorinated pyrolyzed, bulk pyrolysate.
dibenzofurans Testing.
P-14-0712...................... 12/19/2022 Testing Notice................. (G) Plastics, wastes,
pyrolyzed, bulk pyrolysate.
[[Page 2916]]
P-15-0443...................... 12/21/2022 90-Day Inhalation Toxicity (G) Rare earth doped zirconium
Testing (OECD Test Guideline oxide.
413).
P-22-0129...................... 12/14/2022 Water Solubility: Column (G) Substituted heterocyclic
Elution Method; Shake Flask onium compound, salt with
Method (OECD Test Guideline heteropolysubstitutedalkyl
105). substitutedtricycloalkane
carboxylate (1:1), polymer
with 1-alkenyl-4-
[(alkylcycloalkyl)oxy]carbomo
nocycle, 5-ethyloctahydro-4,7-
methano-1h-inden-5-yl 2-
methyl-2-propenoate,
hexahydro-5-oxo-2,6-
methanofuro[3,2-b]furan-3-yl
2-methyl-2-propenoate and 4-
hydroxyphenyl 2-methyl-2-
propenoate.
P-23-0030...................... 12/06/2022 Bacterial Reverse Mutation Test (G) Phenol, polyalkylcarbo bis-
(OECD Test Guideline 471). , polymer with 2-
carbomonocyclichaloheteromono
cycle,
bis[(alkenylcarbomonocyclic)a
lkyl] ether.
----------------------------------------------------------------------------------------------------------------
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: January 12, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2023-00859 Filed 1-17-23; 8:45 am]
BILLING CODE 6560-50-P
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