Notice2024-07895
Certain New Chemicals; Receipt and Status Information for March 2024
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
April 15, 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 3/01/ 2024 to 3/31/2024.
Full Text
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<title>Federal Register, Volume 89 Issue 73 (Monday, April 15, 2024)</title>
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[Federal Register Volume 89, Number 73 (Monday, April 15, 2024)]
[Notices]
[Pages 26142-26146]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07895]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0057; FRL-11683-03-OCSPP]
Certain New Chemicals; Receipt and Status Information for March
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 3/01/
2024 to 3/31/2024.
DATES: Comments identified by the specific case number provided in this
document must be received on or before May 15, 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#592b3831383077333034193c2938773e362f"><span class="__cf_email__" data-cfemail="fb899a939a92d5919296bb9e8b9ad59c948d">[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#eabeb9a9abc7a2859e8683848faa8f9a8bc48d859c"><span class="__cf_email__" data-cfemail="a2f6f1e1e38feacdd6cecbccc7e2c7d2c38cc5cdd4">[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 3/01/2024 to 3/31/2024. 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
[[Page 26143]]
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 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 3/01/2024 to 3/31/2024
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Received
Case No. Version date Manufacturer Use Chemical substance
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J-24-0009A............. 3 03/05/2024 CBI.............. (G) Chemical (G) Chromosomally modified
production. Saccharomyces cerevisiae.
[[Page 26144]]
J-24-0010A............. 3 03/05/2024 CBI.............. (G) Chemical (G) Chromosomally modified
production. Saccharomyces cerevisiae.
J-24-0011A............. 3 03/05/2024 CBI.............. (G) Chemical (G) Chromosomally modified
production. Saccharomyces cerevisiae.
J-24-0012A............. 3 03/05/2024 CBI.............. (G) Chemical (G) Chromosomally modified
production. Saccharomyces cerevisiae
strain.
J-24-0013A............. 3 03/05/2024 CBI.............. (G) Chemical (G) Chromosomally modified
production. Saccharomyces cerevisiae.
P-18-0065A............. 3 03/14/2024 Evonik (S) Absorption (S) 1,3-Propanediamine,
Corporation. agent, lab N1,N1-dimethyl-N3-
reagent. (2,2,6,6-tetramethyl-4-
piperidinyl)-.
P-22-0014A............. 6 03/18/2024 Colonial (G) Precursor.... (G) sodium
Chemical, Inc. bis(chloropropanediol)
phosphate.
P-22-0157A............. 6 03/25/2024 Evonik (S) Polyurethane (S) 1,2-Ethanediamine,
Corporation. catalyst. N1,N2-dimethyl-N1-(1-
methylethyl)-N2-[2-
[methyl(1-
methylethyl)amino]ethyl]-
.
P-22-0176A............. 4 03/14/2024 Colonial (G) Corrosion (G) 6-[(alkyl-1-
Chemical, Inc. inhibitor. oxohexyl)amino]-hexanoic
acid, compd. with
2,2',2''-
nitrilotris[ethanol]
(1:1).
P-23-0086A............. 6 03/04/2024 CBI.............. (G) Additive for (S) 1,2-Benzisothiazole, 3-
surfactant methyl-,1,1-dioxide.
performance
enhancement.
P-23-0096.............. 4 03/08/2024 CBI.............. (G) Open, non- (S) Rosin, fumarated,
dispersive use, polymer with adipic acid
additive for and glycerol.
packaging
industry.
P-23-0174A............. 3 03/08/2024 CBI.............. (G) Component (G) Mixed metal oxide.
used in battery
manufacturing.
P-23-0174A............. 4 03/18/2024 CBI.............. (G) Component (G) Mixed metal oxide.
used in battery
manufacturing.
P-23-0174A............. 5 03/20/2024 CBI.............. (G) Component (G) Mixed metal oxide.
used in battery
manufacturing.
P-24-0025.............. 1 11/09/2023 CBI.............. (G) Paving (G) Functionalized fatty
chemical acids, reaction products
additive. with alkene polyamines,
hydrochlorides.
P-24-0038.............. 1 12/13/2023 CBI.............. (G) Ingredient (S) Bicyclo(2.2.1)hept-5-
for consumer en-2-ol,acetate.
products.
P-24-0062.............. 1 01/11/2024 Flint Hills (S) Raw material (G) Fatty acids, reaction
Resources. in Emulsified products with alkene
Asphalt polyamine,
Production. hydrochlorides.
P-24-0063.............. 1 01/11/2024 Flint Hills (S) Raw material (G) Fatty acids, reaction
Resources. in Emulsified products with alkene
Asphalt polyamine,
Production. hydrochlorides.
P-24-0064.............. 1 01/11/2024 Flint Hills (S) Raw material (G) Fatty acids, reaction
Resources. in Emulsified products with alkene
Asphalt polyamine,
Production. hydrochlorides.
P-24-0065.............. 1 01/11/2024 Flint Hills (S) Raw material (G) Fatty acids, reaction
Resources. in Emulsified products with alkene
Asphalt polyamine,
Production. hydrochlorides.
P-24-0068.............. 1 01/16/2024 Flint Hills (S) Raw material (G) Functionalized fatty
Resources. in Emulsified acids, reaction products
Asphalt with alkene polyamines,
Production. hydrochlorides.
P-24-0080.............. 2 03/19/2024 Seppic........... (S) Function: Non- (S) D-glucoside, undecyl.
ionic surfactant
for industrial
uses and bio
manufacturing
process..
Applications: HI
&I Plant
protection
products; fire-
fighting foam;
Detergents;
oilfield; paper
and textile.
P-24-0081.............. 2 02/29/2024 CBI.............. (G) Adhesive (S) Heptyl 2-
binder. cyanoacrylate.
P-24-0081A............. 3 03/18/2024 CBI.............. (G) Adhesive (S) Heptyl 2-
binder. cyanoacrylate.
P-24-0088A............. 2 03/27/2024 HSAGP Energy, LLC (G) Substance for (G) Mixed metal oxide.
use in the
manufacture of
battery
components.
P-24-0089.............. 1 03/05/2024 CBI.............. (S) Additive for (S) 1H -Imidazole-4,5-
electrochemical dicarbonitrile, 2-
cell (trifluoromethyl)-,
manufacturing. lithium salt (1:1).
P-24-0090.............. 1 03/05/2024 AlzChem, LLC..... (S) Manure (S) Glycine, N-
additive. (aminoiminomethyl)-,
manuf. of, by-products
from.
P-24-0092.............. 1 03/05/2024 Colonial (G) Used in (G) Fatty acid reaction
Chemical, Inc. personal care products with
products. diisopropanolamine.
[[Page 26145]]
P-24-0093.............. 1 03/08/2024 Evonik (S) Surfactant in (G) Rhamnolipids, modified
Corporation. laundry pseudomonas-fermented,
detergent, hard from dextrose, salts.
surface cleaner,
manual/hand dish
detergent.
P-24-0094.............. 1 03/08/2024 Evonik (S) Surfactant in (G) Rhamnolipids, modified
Corporation. laundry pseudomonas-fermented,
detergent, hard from dextrose, salts.
surface cleaner,
manual/hand dish
detergent.
P-24-0095.............. 1 03/08/2024 Evonik (S) Surfactant in (G) Rhamnolipids, modified
Corporation. laundry pseudomonas-fermented,
detergent, hard from dextrose, salts.
surface cleaner,
manual/hand dish
detergent.
P-24-0096.............. 1 03/08/2024 Evonik (S) Surfactant in (G) Rhamnolipids, modified
Corporation. laundry pseduomonas-fermented,
detergent, hard from dextrose, salts.
surface cleaner,
manual/hand dish
detergent.
P-24-0097.............. 1 03/08/2024 CBI.............. (G) Contained use (G) Sulfonium, tris(4-
for fluorophenyl)-,
microlithography (substituted
for electronic phenoxy)alkyl
device substitutedbenzoate
manufacturing. (1:1).
P-24-0098.............. 2 03/18/2024 CBI.............. (G) Contained use (G) Substituted
for heterocyclic onium
microlithography compound, salt with
for electronic fluoropoly.
device Substituted alkyl.
manufacturing. Substituted tricycloalkane
carboxylate (1:1),
polymer with 4-ethenyl-2-
methoxylphenol and
fluoro.
Substituted aromaticalkyl
2-methyl-2-propenoate, di-
Me 2,2'-(1,2-
diazenediyl)bis[2-
methylpropanoate]-
initiated.
P-24-0099.............. 1 03/14/2024 CBI.............. (G) Printing (G) Saturated and
additive. unsaturated hydrocarbon
waxes, oxidized, polymers
with alkenoic acid,
alkanedioic acid,
substituted
carbomonocycle, alkyl
alkenoate, alkenyl
substituted
heteromonocycle, alkylene
glycol, alkyl alkenoate,
alkenedioic acid,
polyalkylene glycol ether
with substituted
carbomonocycle
(alkylidene)bis-,
polyalkylene glycol ether
with substituted
carbomonocycle
(alkylidene)bis-,
alkanoic acid, alkyl
alkenoate, disubstituted
carbomonocycle,
substituted
heteropolycycle, alkyl
peroxide-initiated.
P-24-0100.............. 1 03/13/2024 CBI.............. (G) Wetting agent (G) sulfonyl carbamate of
propoxylated alkyl
alcohol.
P-24-0101.............. 1 03/13/2024 CBI.............. (G) Wetting agent (G) sulfonyl carbamate of
ethoxy/propoxylated alkyl
alcohol ethoxy.
P-24-0102.............. 2 03/26/2024 H.B. Fuller (S) Industrial (G) Polyester polymer with
Company. Adhesive. polyether polymer and
1,1'-methylenebis[4-
isocyanatobenzene].
P-24-0103.............. 2 03/26/2024 H.B. Fuller (S) Industrial (G) Polyester polymer with
Company. Adhesive. polyether polymer and
1,1'-
methylenebis[isocyanatobe
nzene].
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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 3/01/2024 to 3/31/2024
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Commencement
Case No. Received date date If amendment, type of amendment Chemical substance
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J-23-0005............................... 03/27/2024 03/22/2024 N (G) Microorganisms transformed to express
an enzyme.
J-24-0001............................... 03/20/2024 03/08/2024 N (G) Chromosomally modified saccharomyces
cerevisiae.
[[Page 26146]]
J-24-0002............................... 03/20/2024 03/08/2024 N (G) Chromosomally modified saccharomyces
cerevisiae.
P-21-0115............................... 03/26/2024 03/25/2024 N (G) Heteromonocycle, polymer, substituted
aliphatic carbamate, [2-[(1-oxo-2-propen-
1-yl)oxy]alkyl]ester.
P-21-0198............................... 03/01/2024 03/01/2024 N (G) Reaction product of polyester with
alpha-hydro-omega-hydroxypoly(oxy-1,4-
butanediyl) and 1,1'-
methylenebis[isocyanatobenzene],
P-21-0205............................... 03/25/2024 03/15/2024 N (S) Benzene, [2-[(2-methyl-1-undecen-1-
yl)oxy]ethyl]-.
P-22-0019............................... 03/01/2024 02/03/2024 N (G) Protein sodium complexes, polymers
with aromatic acid chloride, ethylene
diamine and amino acid.
P-22-0058............................... 03/14/2024 03/04/2024 N (S) Methanesulfonamide,1,1,1-trifluoro-n-
[(trifluoromethyl)sulfonyl]-, sodium salt
(1:1).
P-22-0082............................... 03/18/2024 02/24/2024 N (G) Alkenoic acid, alkyl, carbopolycyclic
alkyl ester, polymer with trihalo
(trihaloalkyl) alkyl alkyl alkenoate.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 t est information
submitted, and chemical substance identity.
Table III--Test Information Received From 3/01/2024 to 3/31/2024
----------------------------------------------------------------------------------------------------------------
Type of test
Case No. Received date information Chemical Substance
----------------------------------------------------------------------------------------------------------------
P-14-0712........................... 03/25/2024 Polychlorinated (S) Waste plastics,
Dibenzodioxins and pyrolyzed, C5-55 fraction.
Polychlorinated
dibenzofurans Testing.
P-14-0712........................... 03/29/2024 Polychlorinated (S) Waste plastics,
Dibenzodioxins and pyrolyzed, C5-55 fraction.
Polychlorinated
dibenzofurans Testing.
P-24-0097,.......................... 03/12/2024 Water Solubility: (G) Sulfonium, tris(4-
P-24-0098........................... Column Elution Method; fluorophenyl)-,
Shake Flask Method (substituted phenoxy)alkyl
(OECD Test Guideline substituted benzoate
105); Modified OECD (1:1).
316/OPPTS Test
Guideline 835.2210:
Direct Photolysis Rate
in Water by Sunlight;
Direct Aqueous
Photodegradation in
Buffer Solutions;
Estimation of n-
Octanol/Water
Partition Coefficient
Using High Performance
Liquid Chromotography
(HPLC); Determination
of the Dissociation
Constants for Five
Photoacid Generators
(PAGs) in Water and
the Degree of
Dissociation of their
Ion Pairs.
----------------------------------------------------------------------------------------------------------------
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: April 10, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2024-07895 Filed 4-12-24; 8:45 am]
BILLING CODE 6560-50-P
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