[Federal Register Volume 90, Number 35 (Monday, February 24, 2025)]
[Notices]
[Pages 10492-10496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02995]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2025-0067; FRL-12475-01-OCSPP]
Certain New Chemicals; Receipt and Status Information for January
2025
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice 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), an amendment to a previously submitted notice; receipt of test
information; a biotechnology exemption application; an application for
a test marketing exemption (TME); and a notice of commencement of
manufacture (including import) (NOC) for a new chemical substance; 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 1/01/2025 to 1/31/2025.
DATES: Comments must be received on or before March 26, 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 https://www.regulations.gov. 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 https://www.epa.gov/.
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: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
This document provides the receipt and status reports for the
period from 1/01/2025 to 1/31/2025. 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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. 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: https://www.epa.govtsca-inventory.
Any person who intends to manufacture (including import) a new
[[Page 10493]]
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: https://www.epa.gov/under-tsca.
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 regulations.gov 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 https://www.epa.gov/dockets/commenting-epa-dockets.
II. Status Reports
Information about the TSCA section 5 PMNs, SNUNs, MCANs, and
exemption notices 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: https://www.epa.gov/new-chemicals-under-toxic-substances-control-act-tsca/pre-manufacture-notices.
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 1--PMN/SNUN/MCANs Approved *
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Received
Case No. Version date Manufacturer Use Chemical substance
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J-25-0004A.............. 2 01/14/2025 CBI................. (G) Manufacture of (G) Modified Yeast,
an alcohol. with chromosomal
modifications to
improve
fermentation
characteristics.
J-25-0005A.............. 2 01/14/2025 CBI................. (G) Manufacture of (G) Modified Yeast,
an alcohol. with chromosomal
modifications to
improve
fermentation
characteristics.
P-23-0070A.............. 5 01/22/2025 CBI................. (G) Surfactant for (S) Fatty Acids, C8-
cleaning products, 14, methyl-2-
pet shampoo, hand sulfoethyl esters,
cleansing, laundry sodium salts.
detergent and
dishwasher
detergent.
P-23-0192A.............. 2 01/27/2025 Colonial Chemical, (S) Metal working (G) Amides, fatty
Inc. applications. acid, N, N-bis(2-
hydroxypropyl).
[[Page 10494]]
P-24-0034A.............. 2 01/17/2025 Barentz North (S) For use in (S) 2,5,7,10-
America, LLC. laboratories, Tetraoxaundecane,
Elcosol DM is not 4,8-dimethyl-.
included in the
final article: it
is recycled or
recuperated for
treatment/
appropriate
disposal, waters
are treated through
a biological sewage
treatment process
(STP). In consumer
products the NCS is
used as a solvent
or cosolvent.
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 as it
evaporates. There
is no intended
consumer use for
this application.
P-24-0130A.............. 4 01/24/2025 CBI................. (S) Sulfur Scavenger (G)
poly(alkoxy)alkanol
.
P-24-0195A.............. 2 01/22/2025 CBI................. (G) Heat transfer (G) Trimers of
fluid, Dielectric hexafluoropropene.
testing.
P-25-0019A.............. 2 01/24/2025 Cytec Industries, (G) Additive used in (G) Dithiophosphate
Inc. acid production. alkyl ester salt.
P-25-0038A.............. 3 01/28/2025 CBI................. (S) Used in (S) 1,3,5-Triazine-
automotive safety 2,4,6-triamine,
air bag inflators. nitrate (1:1).
P-25-0040A.............. 2 01/22/2025 Motiva Enterprises, (G) Intermediate.... (G) Gases,
LLC. processed.
P-25-0041A.............. 2 01/09/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0041A.............. 3 01/16/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0041A.............. 4 01/23/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0042A.............. 2 01/09/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0042A.............. 3 01/16/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0042A.............. 4 01/23/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0043A.............. 2 01/09/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0043A.............. 3 01/16/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0043A.............. 4 01/23/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0044A.............. 2 01/09/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0044A.............. 3 01/16/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0044A.............. 4 01/23/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0045A.............. 2 01/09/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbons,
LLC. consumer, carbon range.
commercial, and
industrial uses.
P-25-0045A.............. 3 01/16/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbons,
LLC. consumer, carbon range.
commercial, and
industrial uses.
P-25-0045A.............. 4 01/23/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbons,
LLC. consumer, carbon range.
commercial, and
industrial uses.
P-25-0046A.............. 2 01/16/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0046A.............. 3 01/23/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0047A.............. 2 01/16/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0047A.............. 3 01/23/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0048A.............. 2 01/16/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0048A.............. 3 01/23/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0049A.............. 2 01/16/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0049A.............. 3 01/23/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0050A.............. 2 01/16/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses,
Intermediate.
P-25-0050A.............. 3 01/23/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses,
Intermediate.
P-25-0051A.............. 2 01/16/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0051A.............. 3 01/23/2025 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0052A.............. 2 01/15/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0052A.............. 3 01/23/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0053A.............. 2 01/15/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0053A.............. 3 01/23/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0054A.............. 2 01/15/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0054A.............. 3 01/23/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0055A.............. 2 01/15/2025 Motiva Enterprises, (G) Additive used in (G) Hydrocarbon,
LLC. industrial and processed.
commercial
applications.
P-25-0055A.............. 3 01/24/2025 Motiva Enterprises, (G) Additive used in (G) Hydrocarbon,
LLC. industrial and processed.
commercial
applications.
P-25-0056A.............. 2 01/15/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0056A.............. 3 01/23/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0057A.............. 2 01/15/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
[[Page 10495]]
P-25-0057A.............. 3 01/23/2025 Motiva Enterprises, (G) Intermediate.... (G) Hydrocarbon,
LLC. processed.
P-25-0058............... 1 01/02/2025 CBI................. (G) Component of (G) Heteromonocycle
cleaner. alkanol,
homopolymer,
monoalkyl ether.
P-25-0059............... 1 01/21/2025 CBI................. (S) Treatment agent (G) Benzamide,
for pigments.. alkoxy-
[[[[(alkoxyphenyl)a
mino] carbonyl]-
oxoalkyl] diazenyl]-
N-phenyl-.
P-25-0060A.............. 2 01/28/2025 CBI................. (G) Contained use (G) Dibenz
for thiophenium, 5-
microlithography phenyl-, salt with
for electronic fluoroheterosubstit
device utedalkyl
manufacturing. heterosubstitutedha
losubstitutedaromat
ichydrocarboncarbox
ylate (1:1),
polymer with 3-
ethenylphenol and
fluorocarbomonocycl
ealkyl 2-methyl-2-
propenoate.
SN-25-0004A............. 2 01/03/2025 CBI................. (G) Formulation into (S) 1,3-Butanediol,
cosmetic products, (3R)-.
Use as monomer in
polymer industry.
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* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
information and documents have been provided with the submission prior to the start of the 90-day review
period, and in no way reflects the final status of a complete submission review.
In Table 2 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, if applicable, of the type of amendment (e.g., amendment to
generic name, specific name, technical contact information, etc.); and
the chemical substance identity.
Table 2--NOCs Approved *
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Commencement If amendment, type of
Case No. Received date date amendment Chemical substance
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J-24-0020................. 01/03/2025 12/12/2024 N/A..................... (G) Genetically
engineered
microorganism for
chemical production.
P-23-0168................. 01/07/2025 12/20/2024 N/A..................... (G) Sulfamide
fluorophosphate salt.
P-24-0160................. 01/02/2025 12/21/2024 N/A..................... (G) Iodonium, bis
(dialkyl
carbomonocycle) salt
with alkyl
carbomonocycle hetero
acid.
P-24-0190................. 01/02/2025 12/31/2024 N/A..................... (G) Aromatic sulfonium
tricyclo salt with
alkyl carbomonocycle
hetero acid.
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* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
information and documents have been provided with the submission.
In Table 3 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 3--Test Information Received From 1/01/2025 to 1/31/2025
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Type of test Chemical
Case No. Received date information substance
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P-09-0644......... 01/08/2025 Annual PFAS (G) Substituted
Species Testing. alkyl phosphate
ester.
P-09-0645......... 01/08/2025 Annual PFAS (G) Substituted
Species Testing. alkyl phosphate
ester, ammonium
salt.
P-14-0712......... 01/03/2025 Dioxin report.... (S) Waste
plastics,
pyrolyzed, C5-55
fraction.
P-16-0260......... 01/27/2025 Algae toxicity (G) Melamine
test data on pH nitrate.
treated Melamine
nitrate; Fish
acute toxicity
data on Melamine
nitrate; pH
treated Melamine
nitrate process
and chemical
analysis.
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[[Page 10496]]
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: February 14, 2025.
Todd Holderman,
Acting Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2025-02995 Filed 2-21-25; 8:45 am]
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