Certain New Chemicals; Receipt and Status Information for November 2022, 77593-77596 [2022-27448]
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Federal Register / Vol. 87, No. 242 / Monday, December 19, 2022 / Notices
Dated: December 13, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022–27461 Filed 12–16–22; 8:45 am]
BILLING CODE 6717–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2022–0132; FRL–9411–11–
OCSPP]
Certain New Chemicals; Receipt and
Status Information for November 2022
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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 11/1/2022 to 11/
30/2022.
DATES: Comments identified by the
specific case number provided in this
document must be received on or before
January 18, 2023.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0132,
through the Federal eRulemaking Portal
at https://www.regulations.gov. Follow
the online instructions for submitting
comments. Do not submit electronically
any information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Additional
instructions on commenting and visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Jim
Rahai, Project Management and
Operations Division (MC 7407M), Office
tkelley on DSK125TN23PROD with NOTICE
SUMMARY:
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of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–8593; email address: rahai.jim@
epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
This document provides the receipt
and status reports for the period from
11/01/2022 to 11/30/2022. 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
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-chemicalsunder-toxic-substances-control-act-tsca/
status-pre-manufacture-notices. This
information is updated on a weekly
basis.
B. What is the Agency’s authority for
taking this action?
Under the Toxic Substances Control
Act (TSCA), 15 U.S.C. 2601 et seq., a
chemical substance may be either an
‘‘existing’’ chemical substance or a
‘‘new’’ chemical substance. Any
chemical substance that is not on EPA’s
TSCA Inventory of Chemical Substances
(TSCA Inventory) is classified as a ‘‘new
chemical substance,’’ while a chemical
substance that is listed on the TSCA
Inventory is classified as an ‘‘existing
chemical substance.’’ (See TSCA section
3(11).) For more information about the
TSCA Inventory please go to: https://
www.epa.gov/tsca-inventory.
Any person who intends to
manufacture (including import) a new
chemical substance for a non-exempt
commercial purpose, or to manufacture
or process a chemical substance in a
non-exempt manner for a use that EPA
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77593
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-undertsca.
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
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Federal Register / Vol. 87, No. 242 / Monday, December 19, 2022 / Notices
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-chemicalsunder-toxic-substances-control-act-tsca/
status-pre-manufacture-notices. This
information is updated on a weekly
basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that
have passed an initial screening by EPA
during this period, Table I provides the
following information (to the extent that
such information is not subject to a CBI
claim) on the notices screened by EPA
during this period: The EPA case
number assigned to the notice that
indicates whether the submission is an
initial submission, or an amendment, a
notation of which version was received,
the date the notice was received by EPA,
the submitting manufacturer (i.e.,
domestic producer or importer), the
potential uses identified by the
manufacturer in the notice, and the
chemical substance identity.
As used in each of the tables in this
unit, (S) indicates that the information
in the table is the specific information
provided by the submitter, and (G)
indicates that this information in the
table is generic information because the
specific information provided by the
submitter was claimed as CBI.
Submissions which are initial
submissions will not have a letter
following the case number. Submissions
which are amendments to previous
submissions will have a case number
followed by the letter ‘‘A’’ (e.g. P–18–
1234A). The version column designates
submissions in sequence as ‘‘1’’, ‘‘2’’,
‘‘3’’, etc. Note that in some cases, an
initial submission is not numbered as
version 1; this is because earlier
version(s) were rejected as incomplete
or invalid submissions. Note also that
future version 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 11/1/2022 TO 11/30/2022
tkelley on DSK125TN23PROD with NOTICE
Case No.
Received
date
Version
Manufacturer
Use
Chemical substance
J–23–0002 ..........
1
10/07/2022
CBI .....................................
(G) Manufacture of a recombinant protein
P–20–0060A .......
9
11/05/2022
CBI .....................................
P–22–0019A .......
2
11/23/2022
CBI .....................................
(S) Catalyst for polyurethane foam manufacturing.
(G) Film-forming polymer .........................
P–22–0044A .......
3
11/22/2022
CBI .....................................
(G) Site Limited Intermediate ...................
P–22–0107A .......
3
11/29/2022
Locus Fermentation Solutions.
(G) Surfactant for consumer, industrial,
commercial applications.
P–22–0108A .......
3
11/29/2022
Locus Fermentation Solutions.
(G) Surfactant for consumer, industrial,
commercial applications.
P–22–0109A .......
3
11/29/2022
Locus Fermentation Solutions.
(G) Surfactant for consumer, industrial,
commercial applications.
P–22–0110A .......
3
11/29/2022
Locus Fermentation Solutions.
(G) Surfactant for consumer, industrial,
commercial applications.
P–22–0111A .......
3
11/29/2022
Locus Fermentation Solutions.
(G) Surfactant for consumer, industrial,
commercial applications.
P–22–0112A .......
3
11/29/2022
Locus Fermentation Solutions.
(G) Surfactant for consumer, industrial,
commercial applications.
P–23–0006A .......
3
11/04/2022
Siltech, Inc .........................
(G) Additive ..............................................
P–23–0014 .........
4
11/21/2022
CBI .....................................
P–23–0017 .........
2
11/07/2022
Givaudan Fragrances Corp
(S) Intermediate in production of fragrance.
(S) Encapsulant for time-released delivery of fragrance.
P–23–0018 .........
2
11/02/2022
H.B. Fuller Company .........
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(S) Industrial Adhesive .............................
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(G) Microorganism stably transformed to
express a recombinant protein.
(G) Bismuth Carboxylate complexes.
(G) Protein sodium complexes, polymers
with aromatic acid chloride, ethylene
diamine and amino acid.
(G) Silica gel, reaction products with alkyl
metal salt.
(G) Glycolipids, sophorose-contg., yeastfermented, from glycerides and carbohydrates, salts.
(G) Glycolipids, sophorose-contg., yeastfermented, from glycerides and carbohydrates, salts.
(G) Glycolipids, sophorose-contg., yeastfermented, from glycerides and carbohydrates, salts.
(G) Glycolipids, sophorose-contg., yeastfermented, from glycerides and carbohydrates, salts.
(G) Glycolipids, sophorose-contg., yeastfermented, from glycerides and carbohydrates, salts.
(G) Glycolipids, sophorose-contg., yeastfermented, from glycerides and carbohydrates, salts.
(S) Siloxanes and silicones, di-Me, Me
hydrogen, polymers with vinyl groupterminated di-Me siloxanes.
(G) [Polyalkyl-methylenepolyhydropolycyclic]alkyl acetate.
(G) Hydrolyzed collagen, polymer with aromatic isocyanate, N-triethoxysylilalkanamine, pectic polysaccharide and
poly alkyl alcohol.
(G) Vegetable oil, polymer with pimelin
ketone, oxymethylene and
polymethylenepolyphenylene
isocyanate.
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TABLE I—PMN/SNUN/MCANS APPROVED * FROM 11/1/2022 TO 11/30/2022—Continued
Case No.
Received
date
Version
Manufacturer
Use
Chemical substance
(G) Vegetable oil, polymer with pimelin
ketone, oxymethylene and
polymethylenepolyphenylene
isocyanate.
(G) Sulfonium, triphenyl-, polyhydro-5(polyfluoro-2-sulfoalkyl)spiro[4,7methano-1,3-benzodioxole-2,2′polycycloalkane]-5-carboxylate (1:1).
(S) Silsesquioxanes, 3-mercaptopropyl,
polymers with silic acid (H4SiO4) tetraEt ester, [(trimethylsilyl)oxy]-terminated.
(G) Ethylene, polymer with tetrafluoroethylene and hexafluoropropene.
(G) Multi-walled carbon nanotubes.
P–23–0018A .......
3
11/14/2022
H.B. Fuller Company .........
(S) Industrial Adhesive .............................
P–23–0019 .........
2
11/04/2022
CBI .....................................
(G) Photolithography ................................
P–23–0020 .........
1
11/04/2022
Siltech, Inc .........................
(G) Additive/intermediate ..........................
P–23–0021 .........
2
11/16/2022
CBI .....................................
P–23–0022 .........
1
11/11/2022
Cabot Corporation ..............
P–23–0023 .........
1
11/11/2022
Cabot Corporation ..............
P–23–0024 .........
1
11/11/2022
Cabot Corporation ..............
P–23–0025 .........
1
11/11/2022
Solugen, Inc .......................
P–23–0026 .........
1
11/11/2022
Solugen, Inc .......................
P–23–0027 .........
1
11/11/2022
Solugen, Inc .......................
P–23–0029 .........
P–23–0030 .........
1
1
11/14/2022
11/17/2022
CBI .....................................
CBI .....................................
(G) Resin used for the fabrication of articles.
(G) Additive used in industrial applications.
(G) Additive used in industrial applications..
(G) Additive used in industrial applications..
(G) Additive used in consumer, industrial,
and commercial applications.
(G) Additive used in consumer, industrial,
and commercial applications.
(G) Additive used in consumer, industrial,
and commercial applications.
(G) Battery Cathode Manufacturing .........
(G) A polymer of insulating materials ......
P–23–0031 .........
1
11/21/2022
P–23–0032 .........
2
11/28/2022
Tetramer Technologies,
LLC.
ADC—Adrian ......................
P–23–0033 .........
1
11/22/2022
Cabot Corporation ..............
P–23–0034 .........
1
11/23/2022
CBI .....................................
(S) Industrial belting—Tough material
with very good flex fatigue properties to
replace current products.
No crush wheels—used in multiple industries; the good flex fatigue properties,
resilience, and toughness would make
an ideal polymer for this application.
General replacement for
polytetramethylene ether glycol
(PTMEG)-based cast urethane parts
fatigue properties.
(G) Additive used in industrial applications.
(G) Process aid ........................................
SN–22–0007A ....
4
11/11/2022
Braven Environmental, LLC
(G) Product of Pyrolysis manufacturing ...
SN–22–0008A ....
4
11/11/2022
Braven Environmental, LLC
(G) Product of Pyrolysis Manufacturing ...
SN–22–0009A ....
4
11/11/2022
Braven Environmental, LLC
(G) Product of Pyrolysis Manufacturing ...
SN–23–0001 .......
2
11/03/2022
Ultium Cells, LLC ...............
(S) Use as a conductive material in battery cells.
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
(G) Component in Lubricants ...................
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
(G) Multi-walled carbon nanotubes.
(G) Multi-walled carbon nanotubes.
(G) Polycarboxylic acid, salt.
(G) Polycarboxylic acid, salt.
(G) Polycarboxylic acid, salt.
(G) Cobalt metal nickel oxide.
(G) Phenol, polyalkylcarbo bis-, polymer
with 2carbomonocyclichaloheteromonocycle,
bis[(alkenylcarbomonocyclic)alkyl]
ether.
(G) Glycerin, polyalkoxylated, mixed fatty
acid and alkyl diacid esters.
(S) 1,3 propanediol, polymer with 1,3
diisocyanatomethylbenzene.
(G) Multi-walled carbon nanotubes.
(G) Derivative of a
diallyldimethylammonium chloride and
substituted ethylene copolymer.
(S) Waste plastics, pyrolyzed, C5–12
fraction.
(S) Waste plastics, pyrolyzed, C20–55
fraction.
(S) Waste plastics, pyrolyzed, C9–20
fraction.
(G) Single-walled carbon nanotubes.
type of amendment (e.g., amendment to
generic name, specific name, technical
contact information, etc.) and chemical
substance identity.
tkelley on DSK125TN23PROD with NOTICE
TABLE II—NOCS APPROVED * FROM 11/1/2022 TO 11/30/2022
Case No.
P–17–0306A .....
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Commencement
date
11/22/2022
09/11/2022
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If amendment, type of
amendment
Amended generic chemical
name.
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Chemical substance
(G) Vegetable oil, polymer with alkyl dialcohol, cyclic
dicarboxylic anhydride, aromatic dicarboxylic acid, and
polyglycol.
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TABLE II—NOCS APPROVED * FROM 11/1/2022 TO 11/30/2022—Continued
Received date
Commencement
date
P–18–0362 ........
11/03/2022
10/20/2022
N ..........................................
P–19–0019A .....
11/16/2022
08/21/2021
P–19–0108 ........
P–19–0187 ........
11/11/2022
11/11/2022
11/11/2022
11/11/2022
Amended generic chemical
name.
N ..........................................
N ..........................................
Case No.
If amendment, type of
amendment
Chemical substance
(S) 1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer
with 2, 4-diisocyanato-1-methylbenzene, alpha-hydroomega-hydroxypoly[oxy(methyl-1,2-ethanediyl)] and
alpha, alpha prime, alpha double prime-1,2, 3propanetriyltris[omega-hydroxypoly[oxy(methyl-1,3ethandiyl)]], me et ketone oxime blocked.
(G) Chlorofluoroalkane.
(S) Benzoic acid, 2-chloro-4-methyl-, ethyl ester.
(S) Benzoic acid, 2-chloro-4-methyl-, sodium salt (1:1).
* 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 11/1/2022 TO 11/30/2022
Case No.
Received date
P–13–0021 .........
P–16–0543 .........
P–16–0543 .........
11/15/2022
11/28/2022
11/14/2022
Type of test information
Test Data Validation Study ....................................................
Exposure Monitoring Report ..................................................
Exposure Monitoring Report ..................................................
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: December 13, 2022.
Pamela Myrick,
Director, Project Management and Operations
Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2022–27448 Filed 12–16–22; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2016–0743; FRL–9943–02–
OCSPP]
n-Methylpyrrolidone (NMP); Revision
to Toxic Substances Control Act
(TSCA) Risk Determination; Notice of
Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
tkelley on DSK125TN23PROD with NOTICE
AGENCY:
The Environmental Protection
Agency (EPA) is announcing the
availability of the final revision to the
risk determination for the nmethylpyrrolidone (NMP) risk
SUMMARY:
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Chemical substance
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evaluation issued under the Toxic
Substances Control Act (TSCA). The
revision to the NMP risk determination
reflects the announced policy changes
to ensure the public is protected from
unreasonable risks from chemicals in a
way that is supported by science and
the law. EPA determined that NMP, as
a whole chemical substance, presents an
unreasonable risk of injury to health
when evaluated under its conditions of
use. In addition, this revised risk
determination does not reflect an
assumption that workers always
appropriately wear personal protective
equipment (PPE). EPA understands that
there could be adequate occupational
safety protections in place at certain
workplace locations; however, not
assuming use of PPE reflects EPA’s
recognition that unreasonable risk may
exist for subpopulations of workers that
may be highly exposed because they are
not covered by Occupational Safety and
Health Administration (OSHA)
standards, or their employers are out of
compliance with OSHA standards, or
because many of OSHA’s chemicalspecific permissible exposure limits
largely adopted in the 1970’s are
described by OSHA as being ‘‘outdated
and inadequate for ensuring protection
of worker health,’’ or because OSHA has
not issued a chemical-specific
permissible exposure limit (PEL) (as is
the case for NMP), or because EPA finds
unreasonable risk for purposes of TSCA
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(G) Perfluoroacrylate polymer.
(G) Halogenophosphoric acid metal salt.
(G) Halogenophosphoric acid metal salt.
notwithstanding OSHA requirements.
This revision supersedes the condition
of use-specific no unreasonable risk
determinations in the December 2020
NMP Risk Evaluation and withdraws
the associated TSCA order included in
the December 2020 NMP Risk
Evaluation.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2016–0743, is
available online at https://
www.regulations.gov or in-person at the
Office of Pollution Prevention and
Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPPT
Docket is (202) 566–0280. Additional
instructions on 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:
Clara Hull, Office of Pollution
Prevention and Toxics (7404M),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
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]]>Agencies
[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77593-77596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27448]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0132; FRL-9411-11-OCSPP]
Certain New Chemicals; Receipt and Status Information for
November 2022
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
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 11/1/
2022 to 11/30/2022.
DATES: Comments identified by the specific case number provided in this
document must be received on or before January 18, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2022-0132, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Jim Rahai, Project Management
and Operations Division (MC 7407M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-8593; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
This document provides the receipt and status reports for the
period from 11/01/2022 to 11/30/2022. 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 the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.
B. What is the Agency's authority for taking this action?
Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory please go to: https://www.epa.gov/tsca-inventory.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as
appropriate, before initiating the activity. EPA will review the
notice, make a risk determination on the chemical substance or
significant new use, and take appropriate action as described in TSCA
section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: https://www.epa.gov/chemicals-under-tsca.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical 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
[[Page 77594]]
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public docket. Information
so marked will not be disclosed except in accordance with procedures
set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.
II. Status Reports
In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (see the Federal
Register of May 12, 1995 (60 FR 25798) (FRL-4942-7). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g. P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future version 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 11/1/2022 to 11/30/2022
----------------------------------------------------------------------------------------------------------------
Received
Case No. Version date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
J-23-0002.............. 1 10/07/2022 CBI................ (G) Manufacture of (G) Microorganism
a recombinant stably transformed
protein. to express a
recombinant
protein.
P-20-0060A............. 9 11/05/2022 CBI................ (S) Catalyst for (G) Bismuth
polyurethane foam Carboxylate
manufacturing. complexes.
P-22-0019A............. 2 11/23/2022 CBI................ (G) Film-forming (G) Protein sodium
polymer. complexes,
polymers with
aromatic acid
chloride, ethylene
diamine and amino
acid.
P-22-0044A............. 3 11/22/2022 CBI................ (G) Site Limited (G) Silica gel,
Intermediate. reaction products
with alkyl metal
salt.
P-22-0107A............. 3 11/29/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0108A............. 3 11/29/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0109A............. 3 11/29/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0110A............. 3 11/29/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0111A............. 3 11/29/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-22-0112A............. 3 11/29/2022 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. consumer, sophorose-contg.,
industrial, yeast-fermented,
commercial from glycerides
applications. and carbohydrates,
salts.
P-23-0006A............. 3 11/04/2022 Siltech, Inc....... (G) Additive....... (S) Siloxanes and
silicones, di-Me,
Me hydrogen,
polymers with
vinyl group-
terminated di-Me
siloxanes.
P-23-0014.............. 4 11/21/2022 CBI................ (S) Intermediate in (G) [Polyalkyl-
production of methylenepolyhydro-
fragrance. polycyclic]alkyl
acetate.
P-23-0017.............. 2 11/07/2022 Givaudan Fragrances (S) Encapsulant for (G) Hydrolyzed
Corp. time-released collagen, polymer
delivery of with aromatic
fragrance. isocyanate, N-
triethoxysylil-
alkanamine, pectic
polysaccharide and
poly alkyl
alcohol.
P-23-0018.............. 2 11/02/2022 H.B. Fuller Company (S) Industrial (G) Vegetable oil,
Adhesive. polymer with
pimelin ketone,
oxymethylene and
polymethylenepolyp
henylene
isocyanate.
[[Page 77595]]
P-23-0018A............. 3 11/14/2022 H.B. Fuller Company (S) Industrial (G) Vegetable oil,
Adhesive. polymer with
pimelin ketone,
oxymethylene and
polymethylenepolyp
henylene
isocyanate.
P-23-0019.............. 2 11/04/2022 CBI................ (G) (G) Sulfonium,
Photolithography. triphenyl-,
polyhydro-5-
(polyfluoro-2-
sulfoalkyl)spiro[4
,7-methano-1,3-
benzodioxole-2,2'-
polycycloalkane]-5-
carboxylate (1:1).
P-23-0020.............. 1 11/04/2022 Siltech, Inc....... (G) Additive/ (S)
intermediate. Silsesquioxanes, 3-
mercaptopropyl,
polymers with
silic acid
(H4SiO4) tetra-Et
ester,
[(trimethylsilyl)o
xy]-terminated.
P-23-0021.............. 2 11/16/2022 CBI................ (G) Resin used for (G) Ethylene,
the fabrication of polymer with
articles. tetrafluoroethylen
e and
hexafluoropropene.
P-23-0022.............. 1 11/11/2022 Cabot Corporation.. (G) Additive used (G) Multi-walled
in industrial carbon nanotubes.
applications.
P-23-0023.............. 1 11/11/2022 Cabot Corporation.. (G) Additive used (G) Multi-walled
in industrial carbon nanotubes.
applications..
P-23-0024.............. 1 11/11/2022 Cabot Corporation.. (G) Additive used (G) Multi-walled
in industrial carbon nanotubes.
applications..
P-23-0025.............. 1 11/11/2022 Solugen, Inc....... (G) Additive used (G) Polycarboxylic
in consumer, acid, salt.
industrial, and
commercial
applications.
P-23-0026.............. 1 11/11/2022 Solugen, Inc....... (G) Additive used (G) Polycarboxylic
in consumer, acid, salt.
industrial, and
commercial
applications.
P-23-0027.............. 1 11/11/2022 Solugen, Inc....... (G) Additive used (G) Polycarboxylic
in consumer, acid, salt.
industrial, and
commercial
applications.
P-23-0029.............. 1 11/14/2022 CBI................ (G) Battery Cathode (G) Cobalt metal
Manufacturing. nickel oxide.
P-23-0030.............. 1 11/17/2022 CBI................ (G) A polymer of (G) Phenol,
insulating polyalkylcarbo bis-
materials. , polymer with 2-
carbomonocyclichal
oheteromonocycle,
bis[(alkenylcarbom
onocyclic)alkyl]
ether.
P-23-0031.............. 1 11/21/2022 Tetramer (G) Component in (G) Glycerin,
Technologies, LLC. Lubricants. polyalkoxylated,
mixed fatty acid
and alkyl diacid
esters.
P-23-0032.............. 2 11/28/2022 ADC--Adrian........ (S) Industrial (S) 1,3
belting--Tough propanediol,
material with very polymer with 1,3
good flex fatigue diisocyanatomethyl
properties to benzene.
replace current
products.
No crush wheels--
used in multiple
industries; the
good flex fatigue
properties,
resilience, and
toughness would
make an ideal
polymer for this
application.
General replacement
for
polytetramethylene
ether glycol
(PTMEG)-based cast
urethane parts
fatigue properties.
P-23-0033.............. 1 11/22/2022 Cabot Corporation.. (G) Additive used (G) Multi-walled
in industrial carbon nanotubes.
applications.
P-23-0034.............. 1 11/23/2022 CBI................ (G) Process aid.... (G) Derivative of a
diallyldimethylamm
onium chloride and
substituted
ethylene
copolymer.
SN-22-0007A............ 4 11/11/2022 Braven (G) Product of (S) Waste plastics,
Environmental, LLC. Pyrolysis pyrolyzed, C5-12
manufacturing. fraction.
SN-22-0008A............ 4 11/11/2022 Braven (G) Product of (S) Waste plastics,
Environmental, LLC. Pyrolysis pyrolyzed, C20-55
Manufacturing. fraction.
SN-22-0009A............ 4 11/11/2022 Braven (G) Product of (S) Waste plastics,
Environmental, LLC. Pyrolysis pyrolyzed, C9-20
Manufacturing. fraction.
SN-23-0001............. 2 11/03/2022 Ultium Cells, LLC.. (S) Use as a (G) Single-walled
conductive carbon nanotubes.
material in
battery cells.
----------------------------------------------------------------------------------------------------------------
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 11/1/2022 to 11/30/2022
----------------------------------------------------------------------------------------------------------------
Commencement If amendment, type of
Case No. Received date date amendment Chemical substance
----------------------------------------------------------------------------------------------------------------
P-17-0306A................. 11/22/2022 09/11/2022 Amended generic (G) Vegetable oil, polymer
chemical name. with alkyl dialcohol,
cyclic dicarboxylic
anhydride, aromatic
dicarboxylic acid, and
polyglycol.
[[Page 77596]]
P-18-0362.................. 11/03/2022 10/20/2022 N.................... (S) 1,3-propanediol, 2-
ethyl-2-(hydroxymethyl)-,
polymer with 2, 4-
diisocyanato-1-
methylbenzene, alpha-
hydro-omega-
hydroxypoly[oxy(methyl-
1,2-ethanediyl)] and
alpha, alpha prime, alpha
double prime-1,2, 3-
propanetriyltris[omega-
hydroxypoly[oxy(methyl-
1,3-ethandiyl)]], me et
ketone oxime blocked.
P-19-0019A................. 11/16/2022 08/21/2021 Amended generic (G) Chlorofluoroalkane.
chemical name.
P-19-0108.................. 11/11/2022 11/11/2022 N.................... (S) Benzoic acid, 2-chloro-
4-methyl-, ethyl ester.
P-19-0187.................. 11/11/2022 11/11/2022 N.................... (S) Benzoic acid, 2-chloro-
4-methyl-, sodium salt
(1:1).
----------------------------------------------------------------------------------------------------------------
* 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 11/1/2022 to 11/30/2022
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-13-0021........................ 11/15/2022 Test Data Validation Study...... (G) Perfluoroacrylate
polymer.
P-16-0543........................ 11/28/2022 Exposure Monitoring Report...... (G) Halogenophosphoric acid
metal salt.
P-16-0543........................ 11/14/2022 Exposure Monitoring Report...... (G) Halogenophosphoric acid
metal salt.
----------------------------------------------------------------------------------------------------------------
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: December 13, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2022-27448 Filed 12-16-22; 8:45 am]
BILLING CODE 6560-50-P
