Notice2023-28240
Certain New Chemicals; Receipt and Status Information for November 2023
Primary source
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Published
December 22, 2023
Issuing agencies
Environmental Protection Agency
Abstract
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 11/01/ 2023 to 11/30/2023.
Full Text
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<title>Federal Register, Volume 88 Issue 245 (Friday, December 22, 2023)</title>
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[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88606-88609]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28240]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0061; FRL-10581-11-OCSPP]
Certain New Chemicals; Receipt and Status Information for
November 2023
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application (Biotech exemption); an
application for a test marketing exemption (TME), both pending and/or
concluded; a notice of commencement (NOC) of manufacture (including
import) for new chemical substances; and a periodic status report on
new chemical substances that are currently under EPA review or have
recently concluded review. This document covers the period from 11/01/
2023 to 11/30/2023.
DATES: Comments identified by the specific case number provided in this
document must be received on or before January 22, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0061, 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
[[Page 88607]]
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#a0d2c1c8c1c98ecac9cde0c5d0c18ec7cfd6"><span class="__cf_email__" data-cfemail="790b1811181057131014391c0918571e160f">[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#88dcdbcbc9a5c0e7fce4e1e6edc8edf8e9a6efe7fe"><span class="__cf_email__" data-cfemail="6e3a3d2d2f4326011a0207000b2e0b1e0f40090118">[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 11/01/2023 to 11/30/2023. The Agency is providing notice of
receipt of PMNs, SNUNs, and MCANs (including amended notices and test
information); an exemption application under 40 CFR part 725 (Biotech
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a
new chemical substance; and a periodic status report on new chemical
substances that are currently under EPA review or have recently
concluded review.
EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. This information is updated on a
weekly basis.
B. What is the Agency's authority for taking this action?
Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory please go to: <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as
appropriate, before initiating the activity. EPA will review the
notice, make a risk determination on the chemical substance or
significant new use, and take appropriate action as described in TSCA
section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: <a href="https://www.epa.gov/chemicals-under-tsca">https://www.epa.gov/chemicals-under-tsca</a>.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information (CBI). Do not
submit this information to EPA through <a href="http://regulations.gov">regulations.gov</a> or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Status Reports
In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending, or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (see the Federal
Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the
[[Page 88608]]
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 11/01/2023 to 11/30/2023
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Received
Case No. Version date Manufacturer Use Chemical substance
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J-23-0005A............. 2 09/26/2023 CBI.............. (G) Production of (G) Microorganisms
an enzyme. transformed to express an
enzyme.
J-23-0006A............. 2 09/26/2023 CBI.............. (G) Production of (G) Microorganisms
an enzyme. transformed to express an
enzyme.
P-22-0113A............. 5 11/02/2023 SOLUGEN INC...... (G) Chemical (S) D-Glucaric acid.
intermediate,
Additive.
P-22-0123A............. 4 11/13/2023 CBI.............. (G) Mineral (G) Propaneamine, 3-
processing aid. (alkyloxy)-, structural
variants.
P-22-0140A............. 4 11/28/2023 Colonial (G) Corrosion (G) 6-[(alkyl-1-
Chemical, Inc. inhibitor. oxohexyl)amino]-hexanoic
acid, compd. with
cyclohexylamine (1:1).
P-23-0069A............. 4 11/08/2023 CBI.............. (S) Encapsulating (G) Pisum sativum oil,
Shell Polymer glycerol, crosspolymer
for Fragrance; with linear and cyclic
Encapsulates for aliphatic isocyanates.
Industrial or
Household
Consumer
Products such as
Detergents and
Fabric Softeners.
P-24-0001.............. 1 10/03/2023 Cabot Corporation (G) Additive used (G) Carbon Nanostructures,
in industrial purified.
applications.
P-24-0005A............. 8 11/16/2023 CBI.............. (G) Plastic (G) Polycarbomonocyclic
article diol reaction products
production. with
cycloalkylcarbomonocycle
and polysubstituted
heteromonocycle.
P-24-0007.............. 2 11/08/2023 Kenrich (S) Use as a (S) Titanium, branched and
Petrochemicals, dispersant for linear C16-18 and C18-
Inc. powders, all unsatd. fatty acids iso-
forms KR PTOA, Pr alc. complexes.
CAPOW KR PTOA
and CAPS KR
PTOA.; Use as an
adhesion
promoter in
adhesives and
sealants all
forms KR PTOA,
CAPOW KR PTOA
and CAPS KR PTOA.
P-24-0024.............. 1 11/08/2023 Enchem America, (G) Electrolyte (G) Heteroatom-substituted
LLC. additive. dihalo acid, methyl
substituted-alkyl ester.
P-24-0030.............. 1 11/10/2023 Barentz North (S) 2- (S) Heptane, 3,3'-
America, LLC. Ethylhexylal [methylenebis(oxymethylen
currently has e)]bis- (9CI, ACI).
widespread use
as a functional
fluid in
lubricants,
greases, and
other release
products; 2-
Ethylhexylal
currently has
widespread use
in laboratories
as a non-
reactive
processing aid
with no
inclusion into
or onto the
article.; 2-
Ethylhexylal is
also used in
consumer
products as a
solvent or
cosolvent in
coating products.
P-24-0032.............. 1 11/15/2023 Equinor Marketing (S) Hydrocarbon (S) Naphtha (glyceridic),
& Trading (US), value for fuel light catalytic cracked.
Inc. applications
(e.g., use in
motor fuel,
blending stock
for other fuels).
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In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
that have passed an initial screening by EPA during this period: The
EPA case number assigned to the NOC including whether the submission
was an initial or amended submission, the date the NOC was
[[Page 88609]]
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 11/01/2023 to 11/30/2023
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Commencement
Case No. Received date date If amendment, type of amendment Chemical substance
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P-16-0313............................... 11/15/2023 11/02/2023 N (S) Tar acids (shale oil), C6-9 fraction,
alkylphenols, low-boiling.
P-18-0158............................... 11/28/2023 11/01/2023 N (G) Sulfonium, triphenyl-, salt with 2,3-
bis(substituted) 5-sulfocarbopolycyclic-
2,3-carboxylate derivative (1:1).
P-20-0054............................... 11/07/2023 10/07/2020 N (S) Nitrile Hydratase.
P-20-0178A.............................. 11/29/2023 08/02/2023 Amended Generic Chemical Name (G) Carbopolycyclic alkenyl, 2-carboxylic
acid, 2-[[[[[(isocyanatophenyl)alkyl]
carbocycle]-amino]carbonyl]oxy]ethyl
ester.
P-21-0042............................... 11/28/2023 11/01/2023 N (G) Sulfonium, tricarbocyclic-, 2-
heteroatom-substituted-4-
(alkyl)carbomonocyclic carboxylate (1:1).
P-21-0131............................... 11/28/2023 11/01/2023 N (G) Sulfonium, tricarbocyclic-, 2-(4-
alkoxyhalocarbomonocyclic)-alpha, alpha,
beta, beta-polyhalopolyhydro-4,7-methano-
1,3-heteropolycyclic-5-alkanesulfonate
(1:1).
P-22-0018............................... 11/20/2023 11/03/2023 N (G) Substituted polyalkylenepoly, reaction
products with substituted heteromonocycle
substituted heteromonocycle polyalkylene
derivs.
P-22-0022............................... 11/14/2023 11/04/2023 N (G) Aryl-substituted-heterocyclic-
polyamine, reaction products with
polyethylene glycol alkyl-ether, and
nitrogen and alkyl-substituted benzene.
P-23-0013............................... 11/17/2023 11/15/2023 N (S) Phenol, polymer with 4,4'-
bis(chloromethyl)-1,1'-biphenyl.
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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 11/01/2023 to 11/30/2023
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Type of test
Case No. Received date information Chemical substance
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L-23-0173........................... 11/22/2023 Algal Toxicity (OECD (G) Cis-Alkenoic Acid.
Test Guideline 201).
P-16-0543........................... 11/21/2023 Exposure Monitoring (G) Halogenophosphoric acid
Report. metal salt.
P-23-0017........................... 11/29/2023 Human Repeated Insult (G) Hydrolyzed collagen,
Patch Testing. polymer with aromatic
isocyanate, n-
triethoxysylil-alkanamine,
pectic polysaccharide and
poly alkyl alcohol.
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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 18, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2023-28240 Filed 12-21-23; 8:45 am]
BILLING CODE 6560-50-P
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