Notice2022-27448
Certain New Chemicals; Receipt and Status Information for November 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
December 19, 2022
Issuing agencies
Environmental Protection Agency
Abstract
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA Section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 11/1/ 2022 to 11/30/2022.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 242 (Monday, December 19, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77593-77596]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27448]
=======================================================================
-----------------------------------------------------------------------
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 <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#7507141d141c5b1f1c18351005145b121a03"><span class="__cf_email__" data-cfemail="b5c7d4ddd4dc9bdfdcd8f5d0c5d49bd2dac3">[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#1a4e49595b3752756e7673747f5a7f6a7b347d756c"><span class="__cf_email__" data-cfemail="8edaddcdcfa3c6e1fae2e7e0ebceebfeefa0e9e1f8">[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 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: <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
[[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 <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.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 19, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.