90 FR 87 pgs. 19298-19301 - Certain New Chemicals; Receipt and Status Information for February 2025
Type: NOTICEVolume: 90Number: 87Pages: 19298 - 19301
Pages: 19298, 19299, 19300, 19301Docket number: [EPA-HQ-OPPT-2025-0067; FRL-12475-02-OCSPP]
FR document: [FR Doc. 2025-07941 Filed 5-6-25; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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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.
SUMMARY:
[top] 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,
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 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/dockets.
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: rahai.jim@epa.gov .
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov .
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 https://www.epa.gov/chemicals-under-tsca . 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 https://www.epa.gov/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 https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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).
• 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.
• Chemical substance. Name of the chemical substance, or generic name if the specific name is claimed as CBI.
• 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.
• Use(s). Potential uses identified by the manufacturer.
• Received. Date received by EPA.
• Commencement. Date of commencement provided by the submitter in the NOC.
• 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:
• (S) indicates that the information in the table is the specific information provided by the submitter.
• (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?
[top] EPA provides information on its website about cases reviewed under TSCA section 5, including the PMNs, SNUNs, MCANs, and exemption
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).
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| Case No. | Received date | Manufacturer | Use(s) | Chemical substance |
|---|---|---|---|---|
| J-25-0002 | 01/31/2025 | Greenlight Biociences, Inc | (G) To produce DNA for use in internal manufacturing | (G) Strain of Escherichia coli modified with genetically stable, plasmid-borne DNA for the production of plasmid-borne DNA. |
| J-25-0003 | 02/21/2025 | Greenlight Biociences, Inc | (G) To produce an enzyme for use in internal manufacturing | (G) Strain of Escherichia coli modified with genetically stable, plasmid-borne DNA for the production of an enzyme. |
| J-25-0003 | 02/26/2025 | Greenlight Biociences, Inc | (G) To produce an enzyme for use in internal manufacturing | (G) Strain of Escherichia coli 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, Inc | (S) All-purpose hard surface cleaner; Low foam floor scrubber; Spray Metal Cleaning Concentrate | (S) Hexanoic acid, 3,5,5-trimethyl-, sodium salt (1:1). |
| 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 printing ink formulations | (S) 2-Propenoic acid, 3-bromo-2,2-bis(bromomethyl)propyl ester. |
| P-25-0015 | 02/10/2025 | CBI | (G) Additive in paving applications | (G) Modified tall oil 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 Materials, Inc | (S) The CNOs produced do not require any further 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 | (S) Graphene, Carbon Nano-Onions. |
| P-25-0029 | 02/05/2025 | CBI | (G) Functional additive in composite; precursor for high-value nanomaterials | (S) Graphene Oxide. |
| P-25-0030 | 02/05/2025 | CBI | (G) Precursor for high-value nanomaterials; Functional additive in composite. | (S) Graphene Oxide. |
| P-25-0035 | 01/30/2025 | W. R. Grace & Co.-Conn | (G) Used as component in polyethylene production | (G) Transition metal, carbomonocyclic alkyl-substituted, dialkyl. |
| P-25-0055 | 02/06/2025 | Motiva Enterprises, LLC | (G) Additive used in industrial and commercial applications | (G) Hydrocarbon, processed. |
| P-25-0064 | 02/10/2025 | CBI | (G) Contained use for microlithography for electronic device manufacturing | (G) Dibenz thiophenium, 5-phenyl-, salt with fluoroheterosubstitutedalkyl heterosubstitutedhalo substitutedaromatichydro 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 in the manufacture of photoresist | (G) Sulfonium, bis (dihalo carbomonocycle) 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 in the manufacture of photoresist | (G) Sulfonium, bis (dihalo carbomonocycle) carbomonocycle-, salt with trihalobenzoate. |
| SN-23-0024 | 01/30/2025 | CBI | (G) Component in batteries | (S) Phosphoric acid, iron (2+) lithium salt (1:1:1). |
| SN-25-0006 | 02/06/2025 | CBI | (S) Substance for use in the manufacture of battery cathodes | (S) Phosphoric acid, iron (2+) lithium salt (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:
| Case No. | Received date | Commencement 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-. |
Table 3 provides non-CBI information on the test information that has been received by EPA during this time period:
| Case No. | Received date | Type of test information | Chemical substance |
|---|---|---|---|
| P-18-0413 | 02/07/2025 | Acute Earthworm OECD 207; Chronic Earthworm study OECD 222; Reproductive study OECD 443; Range finding study | (G) Haloalkyl alkanoate. |
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: https://www.epa.gov/new-chemicals-under-toxic-substances-control-act-tsca/pre-manufacture-notices.
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]
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