Notice2025-13021
Certain New Chemicals; Receipt and Status Information for March 2025
Primary source
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Published
July 11, 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 2/27/2025 to 3/31/2025.
Full Text
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<title>Federal Register, Volume 90 Issue 131 (Friday, July 11, 2025)</title>
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[Federal Register Volume 90, Number 131 (Friday, July 11, 2025)]
[Notices]
[Pages 30929-30932]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13021]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2025-0067; FRL-12475-03-OCSPP]
Certain New Chemicals; Receipt and Status Information for March
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, and an
opportunity to comment. This document covers the period from 2/27/2025
to 3/31/2025.
DATES: Comments must be received on or before August 11, 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
[[Page 30930]]
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/">https://www.epa.gov/</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: Jim Rahai, Project Management and
Operations Division (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#fa889b929b93d4909397ba9f8a9bd49d958c"><span class="__cf_email__" data-cfemail="4d3f2c252c24632724200d283d2c632a223b">[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#f9adaabab8d4b1968d9590979cb99c8998d79e968f"><span class="__cf_email__" data-cfemail="d98d8a9a98f491b6adb5b0b7bc99bca9b8f7beb6af">[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/">https://www.epa.gov/</a>-
inventory.
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 https://www.epa.gov/dockets/
commenting-epa-dockets.
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 the submission was received by EPA and that
have passed an initial screening and determined to be complete during
this period.
<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
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/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>. 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>.
[[Page 30931]]
III. Receipt Reports
Table 1 provides non-CBI information for the PMNs, SNUNs and MCANs
received by EPA that have passed an initial screening and determined to
be complete consistent with 40 CFR 720.70(a) during this period.
Table 1--PMN/SNUN/MCANs Received and Under Review
----------------------------------------------------------------------------------------------------------------
Received
Case No. date Manufacturer Use(s) Chemical substance
----------------------------------------------------------------------------------------------------------------
P-24-0034A................ 03/20/2025 Barentz North America, (S) In consumer use (S) 2,5,7,10-
LLC. cleaning products, Tetraoxaundecane, 4,8-
the NCS is used as a dimethyl-.
solvent or
cosolvent., For use
in laboratories,
Elcosol DM is not
included in the final
article: it is
recycled or
recuperated for
treatment/appropriate
disposal, waters are
treated through a
biological sewage
treatment process
(STP). There is no
consumer use of this
NCS for this
application. In
industrial and
commercial cleaning
products, Elcosol DM
has widespread use as
a non-reactive
processing aid (no
inclusion into or
onto article). The
substance is not
included in the final
article it is
recycled or
recuperated for
treatment/appropriate
disposal.
P-24-0194................. 3/31/2025 ERGON, INC............. (S) Stabilizer in (G) Modified tall oil
Asphalt Emulsions. fatty acid polyamine
condensate,
hydrochlorides.
P-25-0002A................ 03/21/2025 CBI.................... (G) Catalyst for (G) Poly(oxy-1,2-
polyurethane and ethanediyl), alpha,
polyurethane/epoxy alpha'-
composites. [methylenebis(4,1-
phenyleneiminocarbony
l)] bis [omega-
methoxy-, reaction
products with alkali
metal salt., Benzene,
1,1'-methylenebis [4-
isocyanato-,
homopolymer,
polyethylene glycol
mono-Me ether
blocked, reaction
products with alkali
metal salt.
P-25-0019A................ 03/21/2025 Cytec Industries, Inc.. (G) Additive used in (G) Dithiophosphate
acid production. alkyl ester salt.
P-25-0068A................ 03/21/2025 Cytec Industries, Inc.. (G) Additive used in (G) ether modified
phosphoric acid polyethyleneimine
production. polymer.
P-25-0069................. 02/27/2025 CBI.................... (S) Polymer (G) Poly(oxy-1,2-
intermediate. ethanediyl),
substituted.
P-25-0070A................ 03/17/2025 CBI.................... (G) An ingredient used (G) Sulfonium, bis
in the manufacture of (dihalo
photoresist. carbomonocycle) (halo
carbomonocycle)-,
salt with dihalo-
sulfoalkyl
[(alkenylcarbomonocyc
le)substituted]
trisubstituted
benzoate, polymer
with
alkenylcarbomonocycle
and
alkylcarbomonocycle
alkyl alkenoate.
P-25-0071................. 03/13/2025 CBI.................... (G) An ingredient used (G) Sulfonium, bis
in the manufacture of (dihalo
photoresist. carbomonocycle)
(halocarbomonocycle)-
, salt with
trihalobenzoate.
P-25-0072A................ 03/19/2025 CBI.................... (G) Heat transfer (G) 1-Propene,
fluid, Dielectric polyfluoro-, trimer,
testing. epoxidized.
P-25-0072A................ 03/27/2025 CBI.................... (G) Heat transfer (G) 1-Propene,
fluid, Dielectric polyfluoro-, trimer,
testing. epoxidized
P-25-0073A................ 03/25/2025 CBI.................... (G) Substance for the (G) Cobalt lithium
use in manufacturing manganese nickel
of battery components. oxide, metals.
P-25-0074A................ 03/25/2025 Momentive Performance (S) The new chemical (G) Ethanol, reaction
Materials. substance (NCS) will products with
be used as a coupling methylated
agent in elastomer- formaldehyde-melamine
based formulations polymer and
that will be used in substituted alkane
molding operations to modified
manufacture different triethoxysilane.
types of rubber
articles.
SN-25-0003A............... 03/21/2025 CBI.................... (S) Cathode Active (S) Phosphoric acid,
Material in Batteries. iron (2+) lithium
salt (1:1:1).
SN-25-0004A............... 03/24/2025 CBI.................... (G) Ingredient in the (S) 1,3-Butanediol,
manufacture of (3R)-.
consumer cleaning
products, Use as
monomer in polymer
industry, Formulation
into cosmetic
products.
SN-25-0005A............... 03/24/2025 CBI.................... (G) Electronic (S) 2-Butene,
component 1,1,1,4,4,4-
manufacturing. hexafluoro-, (2Z)-.
SN-25-0006A............... 03/03/2025 CBI.................... (S) Substance for use (S) Phosphoric acid,
in the manufacture of iron (2+) lithium
battery cathodes. salt (1:1:1).
SN-25-0006A............... 03/26/2025 CBI.................... (S) Substance for use (S) Phosphoric acid,
in the manufacture of iron (2+) lithium
battery cathodes. salt (1:1:1).
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[[Page 30932]]
Table 2 provides non-CBI information on the NOCs received by EPA
that have passed an initial screening and determined to be complete
during this period:
Table 2--NOCs Received and Under Review
------------------------------------------------------------------------
Received Commencement
Case No. date date Chemical substance
------------------------------------------------------------------------
J-24-0015.......... 03/19/2025 02/25/2025 (G) Biopolymer
producing modified
microorganism, with
chromosomally
located
modifications.
J-25-0001.......... 03/05/2025 02/11/2025 (G) Biofuel
producing
Saccharomyces
cerevisiae
modified,
genetically stable.
P-19-0049.......... 03/12/2025 03/11/2025 (G) Fatty acids,
polymers with
substituted
carbomonocycles,
dialkanolamine,
alkyl substituted
alkanediamine and
halo-substituted
heteromonocycle,
formates (salts).
P-19-0171.......... 03/11/2025 03/11/2025 (S) Benzoic acid, 2-
chloro-5-fluoro-.
P-19-0176.......... 03/11/2025 03/11/2025 (S) Benzoic acid, 2-
chloro-3-methyl-.
P-22-0053.......... 03/19/2025 03/15/2025 (S) Ethanol, 2-amino-
, compds. with
polyethylene glycol
hydrogen sulfate
C10-16-alkyl ether.
P-23-0178.......... 03/26/2025 03/26/2025 (S) Benzenamine,
4,4'-(9H-fluoren-9-
ylidene) bis-.
------------------------------------------------------------------------
Table 3 provides non-CBI information on the test information that
has been received by EPA and that have passed an initial screening and
determined to be complete during this time period:
Table 3.--Test Information Received and Determined to be Complete
------------------------------------------------------------------------
Received Type of test Chemical
Case No. date information substance
------------------------------------------------------------------------
P-14-0712............ 03/27/2025 Polychlorinated (S) Waste
Dibenzodioxins plastics,
and pyrolyzed, C5-55
Polychlorinated fraction.
dibenzofurans
Testing.
P-16-0543............ 03/20/2025 Exposure (G)
Monitoring Halogenophosphor
Report. ic acid metal
salt.
P-21-0036............ 03/17/2025 Dermal (S) 5-Hexen-2-
Sensitization one, 1-bicyclo
Testing Report. [2.2.1] hept-2-
yl-.
P-21-0079............ 03/17/2025 Freshwater and (S) 13-Oxabicyclo
Saltwater Fish [10.1.0] trideca-
Acute Toxicity 4,8-diene, (4E)-
Test (OECD Test .
Guideline 203);
Repeated Dose 28-
day Oral
Toxicity Study
in Rodents (OECD
Test Guideline
407); In Vitro
Mammalian Cell
Gene Mutation
Tests using the
Thymidine Kinase
Gene (OECD Test
Guideline 490);
Dermal
Sensitization
Testing Report.
P-23-0022............ 03/28/2025 Skin (G) Multi-walled
Sensitization carbon
Test Report; nanotubes.
Respiratory
Sensitization
Test Report.
P-23-0023............ 03/28/2025 Skin (G) Multi-walled
Sensitization carbon
Test Report; nanotubes.
Respiratory
Sensitization
Test Report.
P-23-0024............ 03/28/2025 Skin (G) Multi-walled
Sensitization carbon
Test Report; nanotubes.
Respiratory
Sensitization
Test Report.
P-23-0033............ 03/28/2025 Skin (G) Multi-walled
Sensitization carbon
Test Report; nanotubes.
Respiratory
Sensitization
Test Report.
------------------------------------------------------------------------
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: July 8, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2025-13021 Filed 7-10-25; 8:45 am]
BILLING CODE 6560-50-P
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