Notice2021-28085
Certain New Chemicals; Receipt and Status Information for November 2021
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 28, 2021
Issuing agencies
Environmental Protection Agency
Abstract
EPA is required under the Toxic Substances Control Act (TSCA) 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 11/01/2021 to 11/30/2021.
Full Text
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<title>Federal Register, Volume 86 Issue 246 (Tuesday, December 28, 2021)</title>
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[Federal Register Volume 86, Number 246 (Tuesday, December 28, 2021)]
[Notices]
[Pages 73760-73764]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28085]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2021-0068; FRL-8732-06-OCSPP]
Certain New Chemicals; Receipt and Status Information for
November 2021
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA)
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 11/01/2021 to 11/30/2021.
DATES: Comments identified by the specific case number provided in this
document must be received on or before January 27, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0068 and the specific case number for the
chemical substance related to your comment, through the Federal
eRulemaking Portal at <a href="http://www.regulations.gov">http://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 or visiting the docket, along
with more information about dockets generally, is available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit <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#8efcefe6efe7a0e4e7e3ceebfeefa0e9e1f8"><span class="__cf_email__" data-cfemail="88fae9e0e9e1a6e2e1e5c8edf8e9a6efe7fe">[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#4c181f0f0d61042338202522290c293c2d622b233a"><span class="__cf_email__" data-cfemail="085c5b4b492540677c6461666d486d7869266f677e">[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 11/01/2021 to 11/30/2021. 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 TSCA 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 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
[[Page 73761]]
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="http://www.epa.gov/oppt/newchems">http://www.epa.gov/oppt/newchems</a>.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information (CBI). Do not
submit this information to EPA through <a href="http://regulations.gov">regulations.gov</a> or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="http://www.epa.gov/dockets/comments.html">http://www.epa.gov/dockets/comments.html</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 TSCA section 5 PMN/SNUN/
MCAN and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g., P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.
Table I--PMN/SNUN/MCANs Approved * From 11/01/2021 to 11/30/2021
----------------------------------------------------------------------------------------------------------------
Case No. Version Received date Manufacturer Use Chemical substance
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J-21-0020 2 11/05/2021 Cinder Biological, (G) Enzyme (G) CinderBio-1.
Inc. production.
J-21-0021 2 11/05/2021 Cinder Biological, (G) Enzyme (G) CinderBio-1.
Inc. production.
J-21-0022 2 11/05/2021 Cinder Biological, (G) Enzyme (G) CinderBio-1.
Inc. production.
J-21-0023 2 11/05/2021 Cinder Biological, (G) Enzyme (G) CinderBio-1.
Inc. production.
J-21-0024 2 11/05/2021 Cinder Biological, (G) Enzyme (G) CinderBio-1.
Inc. production.
J-21-0025 2 11/05/2021 Cinder Biological, (G) Enzyme (G) CinderBio-1.
Inc. production.
J-22-0001 1 10/26/2021 CBI................. (G) Chemical (G) Chromosomally-
production. modified
Saccharomyces
cerevisiae.
J-22-0002 1 10/26/2021 CBI................. (G) Chemical (G) Chromosomally-
production. modified
Saccharomyces
cerevisiae.
J-22-0003 1 10/26/2021 CBI................. (G) Chemical (G) Chromosomally-
production. modified
Saccharomyces
cerevisiae.
J-22-0004 1 10/26/2021 CBI................. (G) Chemical (G) Chromosomally-
production. modified
Saccharomyces
cerevisiae.
J-22-0005 1 10/26/2021 CBI................. (G) Chemical (G) Chromosomally-
production. modified
Saccharomyces
cerevisiae.
J-22-0006 1 10/26/2021 CBI................. (G) Chemical (G) Chromosomally-
production. modified
Saccharomyces
cerevisiae.
[[Page 73762]]
J-22-0007 1 10/27/2021 CBI................. (G) Production of (G) Strain of
DNA for use in Escherichia coli
internal modified with
manufacturing. genetically-
stable, plasmid-
borne DNA for the
production of
plasmid-borne DNA.
P-19-0134A 8 11/04/2021 CBI................. (S) Binder for (G) [5-isocyanato-1-
moisture cure (isocyanatomethyl)-
coatings. 1,3,3-
trimethylcyclohexa
ne],
[Poly[oxy(methyl-
1,2-ethanediyl)],
.alpha.-hydro-
.omega.-hydroxy-,
polymer with 1,6-
diisocyanatohexane
], polymer with
[Poly(oxy-1,4-
butanediyl),
.alpha.-hydro-
.omega.-hydroxy-],
[Cyclic amine--
ketone adduct,
reduced], and [1,3-
Propanediol, 2-
ethyl-2-
(hydroxymethyl)-].
P-20-0060 5 11/10/2021 CBI................. (S) Solvent-based (G) Bismuth
pigmented one- and Carboxylate
two-component complexes.
polyurethane
coatings
Automotive
Refinish General
Industrial Coil.
P-20-0096A 5 11/09/2021 Solenis LLC......... (G) Use in (G) Unsaturated
papermaking dicarboxylic acid
process. polymer with 2-
(dialkylamino)alky
l-alkyl-alkanoate,
N, N-dialkyl-
alkene amide, 2-
propenamide and
salt of alkyl-
substituted alkene
sulfonate.
P-20-0127A 5 11/09/2021 Kuraray America, Inc (S) Industrial (S) 2H-Pyran,
Solvent. tetrahydro-4-
methyl-.
P-20-0182A 2 11/19/2021 Eastman Chemical (G) Plasticizer for (S) 1,4-
Company, Inc. PVC formulations. Benzenedicarboxyli
c acid, bis[2-(2-
butoxyethoxy)ethyl
] ester (9 CI).
P-21-0017A 2 11/05/2021 Sumitomo Chemical (S) Substance used (G) [(Substituted-
Advanced to improve carbomonocyclic)
Technologies LLC. physical amino] oxoalkenoic
properties in acid, inorganic
rubber products. salt.
P-21-0049A 5 11/18/2021 CBI................. (G) Monomer........ (G) Alkanoic acid,
polyhalo-(halo-oxo-
alkenyl)oxyalkyl
ester.
P-21-0050A 5 11/18/2021 CBI................. (G) Monomer........ (G) Alkenoic acid,
halo-
polylhaloalkyl
ester.
P-21-0089A 4 11/09/2021 CBI................. (G) Emulsifier..... (G) Lignin,
modified, reaction
products with
alkylamine by-
products,
hydrochlorides.
P-21-0090A 4 11/09/2021 CBI................. (G) Component in (G) Lignin,
paving modified, reaction
formulations. products with
alkylamine by-
products.
P-21-0138A 3 11/15/2021 LG Energy Solution (S) Electrode (G) Lithium metal
Michigan Inc. material for use oxide.
in the manufacture
of batteries.
P-21-0172A 6 11/04/2021 Silco, Inc.......... (S) Moisture (G) Siloxanes and
reactive polymer Silicones, di-Me,
for use in trimethoxysilyl
sealants and group terminated.
coatings.
P-21-0173A 3 11/09/2021 ICM Products Inc.... (G) Additive for (G) Siloxanes and
finishing of silicones
textiles/fabrics. polyether, polymer
with aliphatic
isocyanate, 2-
dimethylaminoethan
ol and polyglycol
ether.
P-21-0213 2 10/28/2021 ICM Products Inc.... (G) Textile (G) Siloxanes and
finishing agent. Silicones, alkyl
methyl, dimethyl.
P-21-0218 3 11/17/2021 Honeycomb Techno (G) Electric (G) Phenol
Research USA Inc. Molding. biphenylene
polycondensate.
P-22-0001 1 10/04/2021 CBI................. (G) Raw material (G) Alkane,
for manufacturing disubstituted.
chemicals.
P-22-0008 2 11/22/2021 CBI................. (G) Biocatalyst (S) .beta.-N-
used in a variety Acetylhexosaminida
of products. se.
P-22-0010 1 11/17/2021 H.B. Fuller Company. (S) This chemical (G) Amino alkanoic
is being used as acid, N-[3-
part of an (Trimethoxysilyl)P
industrial ropyl]-, 3-
adhesive. (Trimethoxysilyl)P
ropyl ester.
P-22-0012 1 11/24/2021 CBI................. (G) (G) Sulfonium,
Photolithography. tricarbocyclic-, 2-
heteroatom-
substituted-4-
(halocarbocyclic)c
arboxylate (1:1).
SN-21-0012 3 11/15/2021 Showa Denko (S) Epoxy molding (S) Oxirane, 2,2''-
Materials compound. [methylenebis[(2,6-
(America), Inc. dimethyl-4,1-
phenylene)oxymethy
lene]]bis-.
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* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
information and documents have been provided with the submission prior to the start of the 90 day review
period, and in no way reflects the final status of a complete submission review.
[[Page 73763]]
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 11/01/2021 to 11/30/2021
----------------------------------------------------------------------------------------------------------------
Commencement If amendment,
Case No. Received date date type of amendment Chemical substance
----------------------------------------------------------------------------------------------------------------
J-21-0006 11/08/2021 11/08/2021 N................ (G) Modified saccharomyces cerevisiae.
J-21-0011 11/11/2021 10/28/2021 N................ (G) Saccharomyces cerevisiae fermenting
C5 sugars, modified.
J-21-0016 11/08/2021 10/11/2021 N................ (G) Modified saccharomyces cerevisiae.
P-01-0925A 11/11/2021 04/16/2004 Update generic (G) 1,2-Ethanediamine, n-[3-
chemical name. trialkoxysilyl) propyl]reaction products
with dialkoxymethyl[3-(oxyanylalkoxy)
propyl] silane and trialkoxy [3-
(oxyanylalkoxy) propyl] silane.
P-01-0926A 11/11/2021 04/16/2004 Update generic (G) Alkenoic acid, 2-methyl-, butyl
chemical name. ester, polymer with 2-hydroxy-3-
phenoxypropyl 2-propenoate and methyl 2-
methyl-2-propenoate.
P-16-0539A 11/24/2021 09/17/2020 Update generic (G) Sulfonium, tricarbocyclic-, alpha,
chemical name. alpha, beta, beta-
polyhalopolyhydrospiro[4,7-methano-1,3-
heteropolycyclic-2,2-cycloalkane]-5-
alkanesulfonate (1:1).
P-16-0548A 11/03/2021 07/09/2020 Update generic (G) Aromatic sulfonium, [([aromatic]-
chemical name. thio)phenyl]phenyl-, fluoro-alkyl
phosphate.
P-17-0206 11/05/2021 07/30/2020 Multiple (G) Imino alkane amine phosphate.
chemicals in a
single
submission were
split out.
P-17-0206 11/05/2021 07/30/2020 Multiple (G) Imino alkane amine phosphate.
chemicals in a
single
submission were
split out.
P-17-0343A 11/01/2021 04/09/2018 Update generic (G) Heteropolycyclic-alkanol,
chemical name. carbomonocycle-alkanesulfonate.
P-18-0012A 11/02/2021 08/31/2021 Update generic (G) Vegetable oil, polymer with alkyl
chemical name. dialcohol, polyglycol, aromatic
dicarboxylic acid and vegetable oil.
P-18-0023A 11/03/2021 09/30/2021 Update generic (G) 1,2-propanediol, 3-[(2-
chemical name. ethylhexyl)oxy]- hydrogen phosphate.
P-18-0035 11/01/2021 06/10/2020 Multiple (S) Propenoic acid, 2-methyl-, 1,3-
chemicals in a dioxolan-4-ylmethyl ester.
single
submission were
split out.
P-18-0035A 11/01/2021 06/10/2020 Multiple (S) 2-propenoic acid, 2-methyl-, 1,3-
chemicals in a dioxan-5-yl ester.
single
submission were
split out.
P-18-0273 11/11/2021 10/20/2021 N................ (S) 1,4-cyclohexanedicarboxylic acid, 1,4-
bis(2-ethylhexyl) ester.
P-18-0282 11/01/2021 10/06/2021 N................ (G) Fatty acid ester, polyether,
diisocyanate polymer,
P-19-0020A 11/02/2021 08/27/2021 Update generic (G) Alkylphenol, reaction products with
chemical name. carbon dioxide, distn. residues from
manuf. of alkylphenol derivs. and
calcium alkylphenol derivs.
P-21-0078 11/17/2021 11/03/2021 N................ (G) Phenol, polymer with alkyl-
(alkylalkylenyl)cyclohexene, mixed
dialkylcyclohexadienes, mixed alkyl-
(alkylalkylidene)cyclohexenes and 3,7,7-
trimethylbicyclo[4.1.0]hept-3-ene,
----------------------------------------------------------------------------------------------------------------
* 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 11/01/2021 to 11/30/2021
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0206 10/27/2021 Fish Acute Toxicity Test, (G) Formaldehyde ketone
Freshwater and Marine (OECD condensate polymer.
Test Guideline 203).
P-16-0543 11/02/2021 Exposure Monitoring Report (G) Halogenophosphoric acid
(September 2021). metal salt.
P-16-0543 11/02/2021 Exposure Monitoring Report (June (G) Halogenophosphoric acid
2021). metal salt.
[[Page 73764]]
P-20-0014 11/01/2021 Pimephales Promelas (Fathead (G) Sugars, polymer with
minnow) Acute Semi-Static alkanetriamine.
Renewal 96-Hour Definitive
Toxicity Test using OCSPP
850.1085 Fish Acute Toxicity
Test mitigate by Humic Acid.
P-20-0014A 11/18/2021 Disassociation Constants in (G) Sugars, polymer with
Water (OECD Test Guideline 112). alkanetriamine.
----------------------------------------------------------------------------------------------------------------
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 21, 2021.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2021-28085 Filed 12-27-21; 8:45 am]
BILLING CODE 6560-50-P
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