Notice2025-07941
Certain New Chemicals; Receipt and Status Information for February 2025
Primary source
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Published
May 7, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This document announces the Agency's receipt of new chemical submissions under the Toxic Substances Control Act (TSCA), including information about the receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN), Microbial Commercial Activity Notice (MCAN), and an amendment to a previously submitted notice; test information; a biotechnology exemption application; an application for a test marketing exemption (TME); and a notice of commencement of manufacture (defined by statute to include import) (NOC) for a new chemical substance. This document also provides a periodic status report on the new chemical substances that are currently under EPA review or have recently concluded review. EPA is hereby providing notice of receipt of this information, as required by TSCA, and an opportunity to comment. This document covers the period from 2/ 1/2025 to 2/25/2025.
Full Text
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<title>Federal Register, Volume 90 Issue 87 (Wednesday, May 7, 2025)</title>
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[Federal Register Volume 90, Number 87 (Wednesday, May 7, 2025)]
[Notices]
[Pages 19298-19301]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07941]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2025-0067; FRL-12475-02-OCSPP]
Certain New Chemicals; Receipt and Status Information for
February 2025
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of receipt and request for comment.
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SUMMARY: This document announces the Agency's receipt of new chemical
submissions under the Toxic Substances Control Act (TSCA), including
information about the receipt of a Premanufacture notice (PMN),
Significant New Use Notice (SNUN), Microbial Commercial Activity Notice
(MCAN), and an amendment to a previously submitted notice; test
information; a biotechnology exemption application; an application for
a test marketing exemption (TME); and a notice of commencement of
manufacture (defined by statute to include import) (NOC) for a new
chemical substance. This document also provides a periodic status
report on the new chemical substances that are currently under EPA
review or have recently concluded review. EPA is hereby providing
notice of receipt of this information, as required by TSCA,
[[Page 19299]]
and an opportunity to comment. This document covers the period from 2/
1/2025 to 2/25/2025.
DATES: Comments must be received on or before June 6, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2025-0067 and the specific case number provided
in this document for the chemical substance related to your comment,
online 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: 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="85f7e4ede4ecabefece8c5e0f5e4abe2eaf3">[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#c195928280ec89aeb5ada8afa481a4b1a0efa6aeb7"><span class="__cf_email__" data-cfemail="8cd8dfcfcda1c4e3f8e0e5e2e9cce9fceda2ebe3fa">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action provides information that is directed to the public in
general.
B. What is the Agency's authority for taking this action?
EPA is publishing this document in the Federal Register as required
by sections 5 of the Toxic Substances Control Act (TSCA), 15 U.S.C.
2601 et seq., and corresponding EPA regulations.
Under TSCA, a chemical substance may be either an ``existing''
chemical substance or a ``new'' chemical substance, see <a href="https://www.epa.gov/chemicals-under-tsca">https://www.epa.gov/chemicals-under-tsca</a>. 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(2) and (11). For more
information about the TSCA Inventory, see <a href="https://www.epa.gov/inventory">https://www.epa.gov/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 new 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 a new
chemical substance, or manufacture or process 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 substances will not present an unreasonable risk of injury
to health or the environment. This is referred to as a test marketing
exemption, or TME.
Premanufacture notification procedures for review of certain new
microbial products of biotechnology are established in 40 CFR part 725.
These pertain to MCANs and biotechnology exemptions, including TSCA
experimental release applications (TERAs), TMEs for microorganisms, and
Tier I and Tier II exemptions.
C. What action is the Agency taking?
This document provides notice of receipt and status reports for the
covered period and certain submissions under TSCA section 5 and
provides an opportunity to comment on this information. The Agency is
providing information about the receipt of PMNs, SNUNs, MCANs, and an
amendment to a previously submitted notice; test information;
biotechnology exemption applications under 40 CFR part 725; TME
applications; NOCs for new chemical substances; and a periodic status
report on chemical substances that are currently under EPA review or
have recently concluded review.
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you wish to include CBI in your
comment, please follow the instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the information that you
claim to be CBI. In addition to one complete version of the comment
that includes CBI, a copy of the comment without CBI must be submitted
for inclusion in the public docket. Information marked as CBI will not
be disclosed except in accordance with procedures set forth in 40 CFR
parts 2 and 703.
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. Background
A. What information is being provided in this document?
The tables in this document provide the following information on
the TSCA section 5 submissions received by EPA during this period and
determined to be complete consistent with 40 CFR 720.70(a).
<bullet> Case number. The EPA number assigned to the TSCA section 5
submissions. Please note that a case number may be listed more than
once in the table when the submission involves a subsequent amendment.
<bullet> Chemical substance. Name of the chemical substance, or
generic name if the specific name is claimed as CBI.
<bullet> Manufacturer. Name of the submitting manufacturer, to the
extent that such information is not subject to a CBI claim. The term
``manufacturer'' is defined by statute to include importer.
<bullet> Use(s). Potential uses identified by the manufacturer.
<bullet> Received. Date received by EPA.
<bullet> Commencement. Date of commencement provided by the
submitter in the NOC.
<bullet> Test information. For test information received, the type
of test information submitted to EPA based on the attachment type and
subtype data selected by the submitter.
B. What do the acronyms mean that are used in the tables?
As used in each of the tables, the following explanations apply:
<bullet> (S) indicates that the information in the table is the
specific information provided by the submitter.
<bullet> (G) indicates that the information in the table is generic
information because the specific information provided by the submitter
was claimed as CBI.
C. How can I access other information about TSCA section 5 submissions?
EPA provides information on its website about cases reviewed under
TSCA section 5, including the PMNs, SNUNs, MCANs, and exemption
[[Page 19300]]
applications received; the date of receipt; the final EPA determination
on the submission; and the effective date of EPA's determination. See
<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>. In addition,
information EPA receives about chemical substances under TSCA,
including non-CBI new chemical submissions, can be accessed in ChemView
at <a href="https://chemview.epa.gov/chemview">https://chemview.epa.gov/chemview</a>.
III. Receipt Reports
Table 1 provides non-CBI information for the PMNs, SNUNs and MCANs
received by EPA during this period that have passed an initial
screening and determined to be complete consistent with 40 CFR
720.70(a).
Table 1--PMN/SNUN/MCANs Received and Under Review
----------------------------------------------------------------------------------------------------------------
Case No. Received date Manufacturer Use(s) Chemical substance
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J-25-0002............. 01/31/2025 Greenlight (G) To produce DNA for (G) Strain of
Biociences, Inc. use in internal Escherichia coli
manufacturing. modified with
genetically stable,
plasmid-borne DNA for
the production of
plasmid-borne DNA.
J-25-0003............. 02/21/2025 Greenlight (G) To produce an enzyme (G) Strain of
Biociences, Inc. for use in internal Escherichia coli
manufacturing. modified with
genetically stable,
plasmid-borne DNA for
the production of an
enzyme.
J-25-0003............. 02/26/2025 Greenlight (G) To produce an enzyme (G) Strain of
Biociences, Inc. for use in internal Escherichia coli
manufacturing. modified with
genetically stable,
plasmid-borne DNA for
the production of an
enzyme.
J-25-0006............. 01/31/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
J-25-0006............. 02/10/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
J-25-0007............. 01/31/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
J-25-0007............. 02/10/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
J-25-0008............. 01/31/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
J-25-0008............. 02/10/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
J-25-0009............. 01/31/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
J-25-0009............. 02/10/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
J-25-0010............. 01/31/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
J-25-0010............. 02/10/2025 CBI................ (G) Chemical Production. (G) Chromosomally
modified Saccharomyces
cerevisiae.
P-22-0149............. 02/12/2025 Colonial Chemical, (S) All-purpose hard (S) Hexanoic acid, 3,5,5-
Inc. surface cleaner; Low trimethyl-, sodium salt
foam floor scrubber; (1:1).
Spray Metal Cleaning
Concentrate.
P-24-0027............. 01/30/2025 Mikros Biochem..... (S) Surfactant.......... (S) Fatty acids, C8-14,
2,3-diesters with rel-
(2R, 3S)-2,3,4-
trihydroxybutyl Beta-D-
mannopyranoside
acetate.
P-24-0082............. 02/12/2025 CBI................ (G) Additive used in 3D (S) 2-Propenoic acid, 3-
printing ink bromo-2,2-
formulations. bis(bromomethyl)propyl
ester.
P-25-0015............. 02/10/2025 CBI................ (G) Additive in paving (G) Modified tall oil
applications. fatty acid polyamine
condensate.
P-25-0018............. 02/07/2025 CBI................ (G) Paint coating....... (S) Graphene platelets.
P-25-0027............. 02/07/2025 Elemental Advanced (S) The CNOs produced do (S) Graphene, Carbon
Materials, Inc. not require any further Nano-Onions.
treatment for its
application on
concrete, resins,
batteries, paints,
asphalt, polyurethanes,
etc. Additionally, the
CNOs are ready to be
combined with other
nanostructures to
create 2nd generation
Li-Ion batteries and
antimicrobial materials
or composites.
P-25-0029............. 02/05/2025 CBI................ (G) Functional additive (S) Graphene Oxide.
in composite; precursor
for high-value
nanomaterials.
P-25-0030............. 02/05/2025 CBI................ (G) Precursor for high- (S) Graphene Oxide.
value nanomaterials;
Functional additive in
composite..
P-25-0035............. 01/30/2025 W. R. Grace & Co.-- (G) Used as component in (G) Transition metal,
Conn. polyethylene production. carbomonocyclic alkyl-
substituted, dialkyl.
P-25-0055............. 02/06/2025 Motiva Enterprises, (G) Additive used in (G) Hydrocarbon,
LLC. industrial and processed.
commercial applications.
[[Page 19301]]
P-25-0064............. 02/10/2025 CBI................ (G) Contained use for (G) Dibenz thiophenium,
microlithography for 5-phenyl-, salt with
electronic device fluoroheterosubstituted
manufacturing. alkyl
heterosubstitutedhalo
substitutedaromatichydr
o carboncarboxylate
(1:1), polymer with 3-
ethenylphenol and alkyl
cycloalkyl 2-methyl-2-
propenoate.
P-25-0066............. 02/14/2025 CBI................ (G) An ingredient used (G) Sulfonium, bis
in the manufacture of (dihalo carbomonocycle)
photoresist. carbomonocycle-, salt
with dihalo-sulfoalkyl
[(alkenylcarbomonocycle
)substituted]
trisubstituted
benzoate, polymer with
alkenylcarbomonocycle
and alkylcarbomonocycle
alkyl alkenoate.
P-25-0067............. 02/14/2025 CBI................ (G) An ingredient used (G) Sulfonium, bis
in the manufacture of (dihalo carbomonocycle)
photoresist. carbomonocycle-, salt
with trihalobenzoate.
SN-23-0024............ 01/30/2025 CBI................ (G) Component in (S) Phosphoric acid,
batteries. iron (2+) lithium salt
(1:1:1).
SN-25-0006............ 02/06/2025 CBI................ (S) Substance for use in (S) Phosphoric acid,
the manufacture of iron (2+) lithium salt
battery cathodes. (1:1:1).
----------------------------------------------------------------------------------------------------------------
Table 2 provides non-CBI information on the NOCs received by EPA
during this period that have passed an initial screening and determined
to be complete:
Table 2--NOCs Received and Under Review
----------------------------------------------------------------------------------------------------------------
Commencement
Case No. Received date date Chemical substance
----------------------------------------------------------------------------------------------------------------
P-19-0150........................ 02/04/2025 01/22/2025 (G) Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-
oxoacetic acid reaction products, sodium
salts.
P-20-0101........................ 02/03/2025 01/10/2025 (G) Alkanoic acid, hydroxy-(hydroxyalkyl)-
alkyl-, polymer with alpha-
[(hydroxyalkyl)alkyl]-omega-
alkoxypoly(oxyalkanediyl),
(haloalkyl)oxiane polymer
(alkylalkylidene)bis[hydroxy-
carbomonocycle] alkenoate and
isocyanatealkyl-carbomonocycle,
hydroxyalkyl acrylate-blocked.
P-21-0215........................ 02/07/2025 02/05/2025 (S) Pyridinium, 3-carboxy-1-methyl-, inner
salt.
P-22-0095........................ 02/19/2025 10/14/2024 (G) Glycolipids, sophorose-contg., yeast-
fermented, from glycerides and
carbohydrates.
P-22-0116........................ 02/26/2025 02/25/2025 (G) Carbopolycycle octa-alkene,
alkenylaryloxy-.
P-22-0151........................ 02/19/2025 02/19/2025 (G) Glycolipids, sophorose-contg., yeast-
fermented, from glycerides and
carbohydrates.
P-23-0015........................ 02/19/2025 01/24/2025 (G) Amines, polyalkylenepoly,
(disubstitutedcarboxy) derivs., alkali
metal salts.
P-23-0173........................ 02/10/2025 01/22/2025 (G) Cellulose, alkoxyalkyl ether, alkali
metal salt.
P-24-0036........................ 02/11/2025 02/04/2025 (G) Poly(oxy-alkylene), -alkenyl--hydroxy-
.
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Table 3 provides non-CBI information on the test information that
has been received by EPA during this time period:
Table 3--Test Information Received and Determined To Be Complete
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
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P-18-0413....................... 02/07/2025 Acute Earthworm OECD 207; (G) Haloalkyl alkanoate.
Chronic Earthworm study OECD
222; Reproductive study OECD
443; Range finding study.
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IV. Status Reports
Information about the TSCA section 5 PMNs, SNUNs, MCANs, and
exemption applications received, including the date of receipt, the
status of EPA's review, the final EPA determination, and the effective
date of EPA's determination, is available online at: <a href="https://www.epa.gov/new-chemicals-under-toxic-substances-control-act-tsca/pre-manufacture-notices">https://www.epa.gov/new-chemicals-under-toxic-substances-control-act-tsca/pre-manufacture-notices</a>.
Authority: 15 U.S.C. 2601 et seq.
Dated: May 1, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2025-07941 Filed 5-6-25; 8:45 am]
BILLING CODE 6560-50-P
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