Notice2024-19304
Certain New Chemicals; Receipt and Status Information for July 2024
Primary source
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Published
August 28, 2024
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 7/01/ 2024 to 7/31/2024.
Full Text
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<title>Federal Register, Volume 89 Issue 167 (Wednesday, August 28, 2024)</title>
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[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68899-68902]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19304]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0057; FRL-11683-07-OCSPP]
Certain New Chemicals; Receipt and Status Information for July
2024
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 7/01/
2024 to 7/31/2024.
DATES: Comments identified by the specific case number provided in this
document must be received on or before September 27, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0057, 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#9be9faf3faf2b5f1f2f6dbfeebfab5fcf4ed"><span class="__cf_email__" data-cfemail="e795868f868ec98d8e8aa7829786c9808891">[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#83d7d0c0c2aecbecf7efeaede6c3e6f3e2ade4ecf5"><span class="__cf_email__" data-cfemail="3c686f7f7d11745348505552597c594c5d125b534a">[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 7/01/2024 to 7/31/2024. 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
[[Page 68900]]
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 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 7/01/2024 to 7/31/2024
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Received
Case No. Version date Manufacturer Use Chemical substance
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P-20-0031............... 1 07/17/2024 CBI............... (G) Intermediate.. (G) Perfluorinated
substituted 1,3-
oxathiolane dioxide.
P-20-0033............... 1 07/17/2024 CBI............... (G) Intermediate.. (G) Perfluorinated
vinyl haloalkane
sulfonate salt.
P-20-0034............... 1 07/17/2024 CBI............... (G) Intermediate.. (G) Perfluorinated
vinyl haloalkane
sulfonyl halide.
P-23-0014............... 1 07/22/2024 CBI............... .................. (G) [Polyalkyl-
methylenepolyhydro-
polycyclic]alkyl
acetate.
P-23-0177A.............. 3 07/19/2024 Colonial Chemical, (G) Corrosion (G) fatty acids,
Inc. inhibitor. vegetable oil,
reaction products with
diethylenetriamine.
P-24-0027A.............. 6 07/08/2024 Mikros Biochem.... (S) Surfactant for (S) Fatty acids, C8-14,
cleaners. 2,3-diesters with rel-
(2R, 3S)-2,3,4-
trihydroxybutyl Beta-D-
mannopyranoside
acetate.
P-24-0079A.............. 4 07/12/2024 CBI............... (G) Fuel Additive. (G) Alkyated
succinimide.
P-24-0079A.............. 5 07/19/2024 CBI............... (G) Fuel Additive. (G) Alkyated
succinimide.
P-24-0104A.............. 5 07/17/2024 CBI............... (G) Plastic (G) carbomonocycle
Additive. alkylamide, 3,5-
bis(1,1-dialkyl) -4-
hydroxy-N-[2,5-dioxo-3-
(polyalkylene)-1-
heteromonocyclic]-.
P-24-0109A.............. 3 07/09/2024 CBI............... (G) Electrolyte (G) Lithium dihalo
salt. (oxalato)borate(1-).
P-24-0109A.............. 4 07/10/2024 CBI............... (G) Electrolyte (G) Lithium dihalo
salt. (oxalato)borate(1-).
P-24-0130A.............. 3 07/12/2024 CBI............... (S) Sulfur (G)
Scavenger. poly(alkoxy)alkanol.
P-24-0161A.............. 3 06/27/2024 Cargill, (S) Feedstock for (S) Fats and glyceridic
Incorporated. production of oils, camelina sativa.
biofuel. Extractives and their
physically modified
derivatives. It
consists primarily of
the glycerides of the
fatty acids
docosenoic,
eicosenoic, linoleic,
linolenic, oleic,
palmitic and stearic.
(Camelina sativa).
P-24-0161A.............. 4 07/08/2024 Cargill, (S) Feedstock for (S) Fats and glyceridic
Incorporated. production of oils, camelina sativa.
biofuel. Extractives and their
physically modified
derivatives. It
consists primarily of
the glycerides of the
fatty acids
docosenoic,
eicosenoic, linoleic,
linolenic, oleic,
palmitic and stearic.
(Camelina sativa).
[[Page 68901]]
P-24-0162A.............. 3 07/25/2024 Proton Power, Inc. (S) Increases (S) single and
strength of multilayer
epoxy, plastics, turbostratic graphene.
moulding
compounds,
strength,
modulus, tear
resistance for
polyurethane
foam; Improves
the rutting
behavior of
asphalt; Improves
the capacity and
thermal and
electrical
conductivity for
batteries,
strength of body
armor and
helmets, drying
time and
antifouling for
paints.
P-24-0164A.............. 2 07/09/2024 Huntsman (S) Intermediate (S) 2-Propanamine, N,N'-
International, in the production (oxydi-2,1-
LLC. of a catalyst. ethanediyl)bis-.
P-24-0171A.............. 2 07/17/2024 CBI............... (G) Making of air (G) Metal and rare
pollutants earth metal zirconium
control parts in oxide.
automobiles.
P-24-0172A.............. 2 07/17/2024 CBI............... (G) Manufacturing (G) Metal and rare
of air pollutants earth metal zirconium
control parts. oxide.
P-24-0173............... 1 07/12/2024 CBI............... (G) For making air (G) Rare earth doped
pollutant control zirconium oxide
parts in
automobiles.
P-24-0174............... 1 07/12/2024 CBI............... (G) Making air (G) Rare earth doped
pollutants zirconium oxide.
control parts in
automobiles.
P-24-0175............... 1 07/12/2024 CBI............... (G) Air pollutants (G) Rare earth doped
control parts in zirconium oxide.
automobiles.
P-24-0176............... 1 07/12/2024 CBI............... (G) Making of air (G) Rare earth doped
pollutants zirconium oxide.
control parts in
automobiles.
P-24-0177............... 1 07/12/2024 CBI............... (G) Air pollutants (G) Rare earth doped
control parts in zirconium oxide.
automobiles.
P-24-0178............... 1 07/15/2024 Advancion......... (G) Paints and (S) 2-Butanol, 3-amino-
coatings, home 3-methyl.
and personal
care, metal
working fluids,
electronics.
P-24-0183............... 1 07/25/2024 HPC Holdings, Inc. (G) Chemical (S) 1-Butanone, 4,4,4-
intermediate. trifluoro-3-hydroxyl-1-
(2-naphthalenyl)-3-
(trifluoromethyl)-.
SN-24-0007A............. 2 07/22/2024 CBI............... (G) Additive for (G) Inorganic acid,
plastic, metal salt, compd.
Intermediate. with substituted
aromatic heterocycle.
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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 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 7/01/2024 to 7/31/2024
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If amendment, type of
Case No. Received date Commencement date amendment Chemical substance
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P-18-0172............................... 07/17/2024 08/28/2019 N........................... (S) Calcium, carbonate 2-ethylhexanoate
neodecanoate propionate complexes.
P-22-0005A.............................. 07/22/2024 07/12/2024 N........................... (S) Formic acid, compd. with 2-methyl-1,5-
pentanediamine (2:1).
P-22-0083............................... 07/16/2024 07/04/2024 N........................... (S) Oils, sandalwood, santalene synthase-
modified Rhodobacter sphaeroides-
fermented, from D-Glucose, oxidized.
P-22-0192............................... 06/27/2024 06/20/2024 N........................... (G) Sulfonium, tricarbocyclic-, polyfluoro-
heteroatom-substituted
polycarbocyclicalkanesulfonate (1:1).
P-23-0124............................... 06/27/2024 06/20/2024 N........................... (G) Sulfonium, tricabocyclic-, 2-
heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1).
P-23-0126............................... 07/15/2024 07/08/2024 N........................... (G) Alken-1-ol.
P-23-0135............................... 07/15/2024 07/08/2024 N........................... (G) Alken-1-ol, 1-acetate.
P-23-0172............................... 06/27/2024 06/20/2024 N........................... (G) Sulfonium, tricarbocyclic-,
alkylcarbomocyclic-polyfluoro-
heteropolycyclic-alkyl sulfonate (1:1),
polymer with alkylaryl and
carbomonocyclic alkylalkanoate, di-Me
2,2'-(1,2-diazenediyl)bis(2-
alkylalkanoate)-initiated.
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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 7/01/2024 to 7/31/2024
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Received
Case No. date Type of test information Chemical substance
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L-23-0173............................ 07/09/2024 Algal Toxicity (OECD Test (G) Cis-alkenoic acid.
Guideline 201).
[[Page 68902]]
P-14-0712............................ 07/10/2024 Polychlorinated (S) Waste plastics,
Dibenzodioxins and pyrolyzed, C5-55 fraction.
Polychlorinated
dibenzofurans Testing.
P-18-0124............................ 07/08/2024 90-Day Inhalation Toxicity (S) Lithium nickel potassium
(OECD Test Guideline 413). oxide.
P-21-0202, P-23-0104................. 07/23/2024 Determination of Dissociation (G) Sulfonium, carbomonocycle
Constant (Conductometric bis[(trihaloalkyl)carbomonoc
Method; OECD Guideline 112 ycle], substituted
OPPTS 830.7370). carbomonocyclic ester; (G)
Sulfonium, carbomonocycle
bis[(trihaloalkyl)carbomonoc
ycle], disubstituted
carbomonocyclic ester.
P-24-0154............................ 07/12/2024 Melting Point/Melting Range (G) Polyphenyl, ethoxy-
(OECD Test Guideline 102); polyfluoro-alkyl-.
Boiling Point/Boiling Range
(OECD Test Guideline 103);
Storage Stability (OECD Test
Guideline 113); Combined
Repeated Dose Toxicity with
the Reproduction/Development
Toxicity Screening Test
(OECD Test Guideline 422);
Particle Size, Fiber Length,
Diameter Distribution (OECD
Test Guideline 110); Density/
Relative Density/Bulk
Density (OECD Test Guideline
109); In Vitro Skin
Irritation Testing; Primary
Skin Irritation Testing in
Rabbits.
P-24-0154............................ 07/12/2024 Acute Oral Toxicity (OECD (G) Polyphenyl, ethoxy-
Test Guideline 423); Acute polyfluoro-alkyl-.
Eye Irritation (OECD Test
Guideline 405); Bovine
Corneal Opacity and
Permeability Test Method for
Identifying i) Chemicals
Inducing Serious Eye Damage
and ii) Chemicals Not
Requiring Classification for
Eye Irritation or Serious
Eye Damage (OECD Test
Guideline 437); In Vitro
Mammalian Chromosome
Aberration Test (OECD Test
Guideline 473); Skin
Sensitization (OECD Test
Guideline 429); Flammability
Testing; Bacterial Reverse
Mutation Test (OECD Test
Guideline 471).
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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: August 22, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2024-19304 Filed 8-27-24; 8:45 am]
BILLING CODE 6560-50-P
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