[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Pages 16626-16630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05598]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0132; FRL-10581-02-OCSPP]
Certain New Chemicals; Receipt and Status Information for
February 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 2/1/
2023 to 2/28/2023.
DATES: Comments identified by the specific case number provided in this
document must be received on or before April 19, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0132, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically
[[Page 16627]]
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 (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 2/01/2023 to 2/28/2023. 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/inventory.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as
appropriate, before initiating the activity. EPA will review the
notice, make a risk determination on the chemical substance or
significant new use, and take appropriate action as described in TSCA
section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: https://www.epa.gov/chemicals-under-tsca.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that 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
[[Page 16628]]
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 02/01/2023 to 02/28/2023
----------------------------------------------------------------------------------------------------------------
Case No. Version Received date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
J-23-0004............... 1 02/08/2023 Danisco US, Inc... (G) Production of (G) Genetically
a chemical modified
substance. microorganism for
the production of a
chemical substance.
P-19-0095A.............. 8 02/07/2023 CBI............... (G) Consumer (G) Poly hydroxy
Disposables, alkanoate.
Polymer Sheet,
Durable Goods.
P-21-0086A.............. 5 02/02/2023 Croda, Inc........ (G) Industrial (S)
Rolling oil, Isooctadecanamide,
Compressor oil, N,N-bis(2-
hydraulic oil, ethylhexyl).
Industrial
turbine oil,
Industrial gear
oil, Automotive
gear oil,
Refrigeration
oil, Industrial
drilling oil,
Marine engine oil
additive,
Automotive engine
oil additive,
polymer additive,
Greases, Metal
working fluid.
P-21-0086A.............. 6 02/27/2023 Croda, Inc........ (G) Industrial (S)
Rolling oil, Isooctadecanamide,
Compressor oil, N,N-bis(2-
hydraulic oil, ethylhexyl).
Industrial
turbine oil,
Industrial gear
oil, Automotive
gear oil,
Refrigeration
oil, Industrial
drilling oil,
Marine engine oil
additive,
Automotive engine
oil additive,
polymer additive,
Greases, Metal
working fluid.
P-22-0054A.............. 3 02/01/2023 CBI............... (G) Additive for (G) Graphene
paint and nanoplatelets.
coatings.
P-22-0071A.............. 4 02/24/2023 Lamberti USA, Inc. (G) Industrial (S) D-Glucopyranose,
Surfactant. oligomeric,
maleates, C9-11-
alkyl glycosides,
sulfonated,
potassium salts.
P-22-0072A.............. 4 02/24/2023 Lamberti USA, Inc. (G) Industrial (S) D-Glucopyranose,
Surfactant. oligomeric,
maleates, decyl
octyl glycosides,
sulfonated,
potassium salts.
P-22-0073A.............. 4 02/24/2023 Lamberti USA, Inc. (G) Industrial (S) D-Glucopyranose,
Surfactant. oligomeric,
maleates, C10-16-
alkyl glycosides,
sulfonated,
potassium salts.
P-22-0095A.............. 3 02/03/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, and yeast-fermented,
commercial from glycerides and
applications. carbohydrates.
P-22-0096A.............. 3 02/03/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, and yeast-fermented,
commercial from glycerides and
applications. carbohydrates.
P-22-0097A.............. 3 02/03/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, and yeast-fermented,
commercial from glycerides and
applications. carbohydrates.
P-22-0098A.............. 3 02/03/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, and yeast-fermented,
commercial from glycerides and
applications. carbohydrates.
P-22-0099A.............. 3 02/03/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, and yeast-fermented,
commercial from glycerides and
applications. carbohydrates.
P-22-0100A.............. 3 02/03/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, and yeast-fermented,
commercial from glycerides and
applications. carbohydrates.
P-22-0119A.............. 4 02/15/2023 CBI............... (G) Resin for (G)
packaging, Polyhydroxyalkanoat
Binding agent. e.
P-22-0120A.............. 4 02/15/2023 CBI............... (G) Resin for (G)
packaging Polyhydroxyalkanoat
materials, Binder. e.
P-22-0151A.............. 2 02/01/2023 CBI............... (G) Surfactant for (G) Glycolipids,
commercial sophorose-contg.,
applications. yeast-fermented,
from glycerides and
carbohydrates.
P-22-0151A.............. 3 02/03/2023 CBI............... (G) Surfactant for (G) Glycolipids,
commercial sophorose-contg.,
applications. yeast-fermented,
from glycerides and
carbohydrates.
P-22-0151A.............. 4 02/15/2023 CBI............... (G) Surfactant for (G) Glycolipids,
commercial sophorose-contg.,
applications. yeast-fermented,
from glycerides and
carbohydrates.
[[Page 16629]]
P-23-0063............... 1 01/08/2023 CBI............... (G) Dyestuff...... (G) 3-
Heteromonocycle
methanesulfonic
acid, 5-[2-[5-[[4-
chloro-6-[[3(or 4)-
sulfo-
carbomonocyclic]ami
no]heteromonocyclic
]amino]-2-
sulfocarbomonocycli
c]diazenyl]-1-ethyl-
6-hydroxy-4-methyl-
2-oxo-, sodium salt
(1:3).
P-23-0066A.............. 2 02/06/2023 CBI............... (G) An antioxidant (G) alkylated phenyl-
additive. naphthalene amine.
P-23-0067............... 2 02/01/2023 CBI............... (G) cleaner....... (G) Ethoxylated
Fatty Acid Amide.
P-23-0067A.............. 3 02/23/2023 CBI............... (G) Cleaner....... (G) Ethoxylated
Fatty Acid Amide.
P-23-0068A.............. 5 02/21/2023 US Polymers (S) Ingredient in (S) 1,3-
Accurez, LLC. industrial Isobenzofurandione,
primers and hexahydro-, polymer
topcoats. with 1,4-
cyclohexanedimethan
ol, isononanoate.
P-23-0069............... 2 02/07/2023 CBI............... (S) Encapsulating (G) Pea extract,
Shell Polymer for glycerol,
Fragrance carboxymethyl
Encapsulates for cellulose sodium
Industrial or salt, sodium
Household hyaluronate,
Consumer Products maltodextrin and
such as tannins crosslinked
Detergents and polymer with linear
Fabric Softeners. and cyclic
aliphatic
isocyanates.
P-23-0072............... 2 01/31/2023 Allnex USA, Inc... (S) UV resin for (G) Halosubstituted
offset carbopolycycle,
lithographic polymer with
printing on substituted
plastic carbomonocycles and
substrates. oxybis[alkanol].
P-23-0077............... 2 02/06/2023 CBI............... (G) Additive for (G) Alkanepolyoxy
industrial acid, alkyl
applications. substituted.
P-23-0078............... 3 02/15/2023 Huntsman (S) Polyester (G) soybean oil
International, polyol which will polymer with
LLC. be used in alkylene glycol-
combination with and glycerol- and
other ingredients alkylene glycol-
to make the B and alkylene glycol-
side of a spray depolymd.
polyurethane foam poly(alkylene
formulation. The terephthalate),
A side hydroxy-
(isocyanate) and (hydroxyalkyl)-
B side are alkylalkanoic acid
reacted together phthalic anhydride.
to produce a
polyurethane foam
that is used as
insulation in
buildings.
P-23-0080............... 1 02/06/2023 CBI............... (G) Photoacid (G) Aromatic
generator (PAG) sulfonium tricyclo
for use in fluoroalkyl
semiconductor sulfonic acid salt.
industry.
P-23-0081............... 2 02/15/2023 Ashland, Inc...... (S) Polymer used (G) Alkyl glycidyl
as non-ionic ether, polymer with
surfactant in Poly(oxy-1,2-
wood coating ethanediyl).
formulations.
P-23-0083............... 1 02/08/2023 CBI............... (G) (G) Sulfonium,
Photolithography. tricarbocyclic-,
[polyhydro-alkyl-
(polyfluoro-2-
heteroatom
substituted)-alkano-
heteromonocyclic]
alkyl ester (1:1).
P-23-0084............... 1 02/09/2023 Colonial Chemical, (S) Lubricant (G) amides,
Inc. additive, water vegetable oil,
based cutting hydroxylated amine.
fluids,
institutional
cleaning
products, and
cleaning in place
applications,
Surfactant used
in personal care
products such as
body cleansers,
shower gels,
shampoos, etc.
Aids foam
boosting, foam
stabilization,
viscosity
control, skin
emolliency,
wetting,
detergency,
emulsification,
and
solubilization in
solid actives.
P-23-0084A.............. 2 02/16/2023 Colonial Chemical, (S) Lubricant (G) amides,
Inc. additive, water vegetable oil,
based cutting hydroxylated amine.
fluids,
institutional
cleaning
products, and
cleaning in place
applications,
Surfactant used
in personal care
products such as
body cleansers,
shower gels,
shampoos, etc.
Aids foam
boosting, foam
stabilization,
viscosity
control, skin
emolliency,
wetting,
detergency,
emulsification,
and
solubilization in
solid actives.
P-23-0085............... 1 02/09/2023 Colonial Chemical, (S) Lubricant (G) amides, soya,
Inc. additive, water hydroxylated amine.
based cutting
fluids,
institutional
cleaning
products, and
cleaning in place
applications (G)
Personal care
surfactant.
P-23-0085A.............. 2 02/16/2023 Colonial Chemical, (S) Lubricant (G) amides, soya,
Inc. additive, water hydroxylated amine.
based cutting
fluids,
institutional
cleaning
products, and
cleaning in place
applications,
Surfactant used
in personal care
products such as
body cleansers,
shower gels,
shampoos, etc.
Aids foam
boosting, foam
stabilization,
viscosity
control, skin
emolliency,
wetting,
detergency,
emulsification,
and
solubilization in
solid actives.
(G) Personal care
surfactant.
[[Page 16630]]
P-23-0087............... 1 02/10/2023 Evonik Corporation (S) Adhesives and (S) Oxirane, 2-
Sealants for methyl-, polymer
various with 2-[[3-
applications. (triethoxysilyl)pro
poxy]methyl]oxirane
, monoether with -
butyl--hydroxypoly[
oxy(methyl-1,2-
ethanediyl)].
P-23-0093............... 2 02/23/2023 CBI............... (G) Photoacid (G) Aromatic
generator (PAG) Dibenzothiophenium
for use in fluoroalkyl
semiconductor carbopolycycle
industry. sulfonic acid salt.
P-23-0094............... 1 02/24/2023 Sika Corporation.. (S) Reactive (G) Polymer of
polymer for use benzenedicarboxylic
in surface pre- acid, substituted-
treatment.. benzenedicarboxylic
acid, branched-
alkyldiol,
alkyldiol and
triisocyanate.
SN-22-0006A............. 3 02/13/2023 MacDermid Enthone, (G) Catalyst (S) Tungstate
Inc. (contained use). (W12(OH)2O386-),
sodium (1:6).
----------------------------------------------------------------------------------------------------------------
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 02/01/2023 to 02/28/2023
----------------------------------------------------------------------------------------------------------------
Commencement If amendment, type of
Case No. Received date date amendment Chemical substance
----------------------------------------------------------------------------------------------------------------
P-13-0471.................. 02/01/2023 01/24/2023 N.................... (G) Methylene diisocyanate
polymer with
polypropylene glycol and
diols (generic).
P-14-0069.................. 02/07/2023 01/13/2023 N.................... (G) Polymer of substituted-
naphthalene, substituted-
benzenecarboxylic acid,
benzenediol and
substituted-naphthalene.
P-16-0495.................. 02/02/2023 02/02/2023 N.................... (G) 2-pentanol, 4-methyl-,
reaction products with
phosphorus oxide (p2o5),
compounds with
alkylamine.
P-19-0076.................. 02/02/2023 01/10/2023 N.................... (G) Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with
dihalo substituted alkyl
carbopolycyclic
carboxylate (1:1).
P-19-0188.................. 02/13/2023 02/01/2023 N.................... (G) Octadecenamide, n,n-
alkyl, modified.
P-21-0077.................. 02/21/2023 12/10/2022 N.................... (G) Alkylene sulfate.
P-21-0187A................. 02/14/2023 09/14/2022 Amendment requested (G) Glycerine, alkoxylated
by EPA regarding CBI alkyl acid esters.
request reasoning.
P-21-0199.................. 02/28/2023 01/30/2023 N.................... (G) 1,6-disubstituted
hexane (see cover
letter).
P-21-0202.................. 02/02/2023 01/10/2023 N.................... (G) Sulfonium,
carbomonocycle
bis[(trihaloalkyl)carbomo
nocycle], substituted
carbomonocyclic ester.
P-22-0009.................. 02/15/2023 02/12/2023 N.................... (S) Alkanes, c4-c9-
branched and linear.
P-22-0017.................. 02/13/2023 02/07/2023 N.................... (S) 1-eicosanol, manuf.
of, distn., residues.
----------------------------------------------------------------------------------------------------------------
* 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.
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: March 14, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2023-05598 Filed 3-17-23; 8:45 am]
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