90 FR 158 pgs. 40360-40364 - Certain New Chemicals; Receipt and Status Information for June 2025
Type: NOTICEVolume: 90Number: 158Pages: 40360 - 40364
Pages: 40360, 40361, 40362, 40363, 40364Docket number: [EPA-HQ-OPPT-2025-0067; FRL-12475-06-OCSPP]
FR document: [FR Doc. 2025-15726 Filed 8-18-25; 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-12475-06-OCSPP]
Certain New Chemicals; Receipt and Status Information for June 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
DATES:
Comments must be received on or before September 18, 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 (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: 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/tsca-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 amendments 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 the submission was 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?
[top] 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?
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 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices . In addition, information EPA receives about chemical substances under TSCA, including non-CBI new chemical submissions, can be accessed in ChemView at https://chemview.epa.gov/chemview .
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.
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Case No. | Received date | Manufacturer | Use | Chemical substance |
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P-21-0059 | 06/24/2025 | CBI | (G) Stabilizer | (S) Methanesulfonic acid,1,1,1-trifluoro-, ytterbium (3+) salt (3:1). |
P-22-0158 | 06/18/2025 | Aqdot | (G) Additive used in consumer, commercial, and industrial applications | (S) 1H,4H,14H,17H-2,16:3,15-Dimethano-5H,6H,7H,8H,9H,10H,11H, 12H,13H,18H,19H,20H,21H,22H,23H,24H,25H,26H-2,3,4a,5a,6a,7a,8a,9a,10a,11a, 12a,13a,15,16,17a,18a,19a,20a,21a,22a,23a,24a,25a,26a- tetracosaazabispentaleno[1"',6"': 5",6",7"]cycloocta[1",2",3": 3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-g'h'] cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-1,4,6,8,10,12,14,17,19,21,23, 25-dodecone, dodecahydro-, stereoisomer;2,18:3,17-Dimethano-2,3,4a,5a, 6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,17,18,19a,20a,21a,22a,23a,24a,25a, 26a,27a,28a,29a,30aoctacosaazabispentaleno[1""', 6""':5"",6"",7""] cycloocta[1"",2"",3"":3"', 4"']pentaleno[1"',6"':5",6",7"] cycloocta[1",2",3":3',4']pentaleno[1',6':5,6,7]cycloocta[1, 2,3-cd:1',2',3'-gh]pentalene-1,4,6,8,10,12,14,16,19,21,23,25,27,29-tetradecone, tetradecahydro-, stereoisomer;2,20:3,19-Dimethano-2,3,4a,5a,6a,7a,8a, 9a,10a,11a,12a,13a,14a,15a,16a,17a,19,20,21a,22a,23a,24a,25a,26a,27a,28a,29a, 30a,31a,32a,33a,34adotriacontaazabispentaleno[1""',6""' :5"",6"",7""]cycloocta[1"", 2"",3"":3"',4"']pentaleno[1"',6"' :5",6",7"]cycloocta[1",2",3":3',4']pentaleno [1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-g'h']cycloocta[1,2,3-cd:5,6,7-c'd'] dipentalene-1,4,6,8,10,12,14,16,18,21,23,25,27,29,31,33-hexadecone,hexadecahydro-, stereoisomer. |
P-23-0081 | 05/30/2025 | Ashland, Inc | (S) Gas., Polymer used as a non-ionic surfactant in water-based separator coatings used in the manufacture of batteries registered pesticide products | (G) Alkyl glycidyl ether, polymer with Poly(oxy-1,2-ethanediyl). |
P-24-0083 | 06/02/2025 | CBI | (G) Ingredient for cleaning products, Ingredient for cleaning products | (G) Branched alcohol alkoxylate. |
P-24-0186 | 06/26/2025 | SGP Ventures, Inc | (S) Epoxy used to fill holes in printed circuit boards | (S) 2-Oxiranemethanamine, N-[2-methyl-4-(2-oxiranylmethoxy) phenyl]-N-(2-oxiranylmethyl)-. |
P-24-0191 | 06/10/2025 | CBI | (G) Conductive agent | (S) Carbon nanotube, multi-walled in tubular shape. |
P-25-0065 | 06/02/2025 | Itaconix Corp | (S) Chemical intermediate in polymer production | (S) Butanedioic acid, 2-methylene-, 1,4-dimethyl ester; Butanedioic acid, 2-methylene-, 1-ethyl 4-methyl ester; Butanedioic acid, 2-methylene-, 4-ethyl 1-methyl ester. |
P-25-0098 | 05/29/2025 | CBI | (G) Photolithography | (G) Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-polyfluoropolyhydro-2-(haloheterocyclic)-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1). |
P-25-0100 | 05/22/2025 | CBI | (G) Exported for use outside the US, Photoacid generator use at customer sites | (G) Aromatic sulfonium tricyclo salt with alkyl carbomonocycle hetero acid. |
P-25-0103 | 06/05/2025 | CBI | (G) Component of photoresist | (G) Alkanedioic acid, polyhalo, carbomonocycle [[(alkyl-substituted alkenyl) substituted] alkyl] ester, homopolymer. |
P-25-0105 | 05/29/2025 | CBI | (S) Treatment agent for pigments | (G) Alkanamide, 2,2'-[(halo[1,1'-biphenyl]-4,4'-diyl) bis(2,1-diazenediyl)] bis [3-oxo-, N,N'-bis(heterocyclic aryl and di-substituted aryl). |
P-25-0106 | 05/30/2025 | CBI | (G) Component of photoresist | (G) Sulfonium tris(substitutedcarbomonocycle) substituted oxatricycloalkyloxycarbonyl dihalo alkane sulfonate. |
P-25-0107 | 05/30/2025 | CBI | (G) Component of photoresist | (G) Heteromonocyclic alkylsubstituted carbomonocyclic carbopolycyclic heteromonocyclic dihalo sulfoacetate. |
P-25-0109 | 06/11/2025 | CBI | (S) Treatment agent for pigments., Treatment agent for pigments in inks | (G) Alkanamide, 2,2-[(dihalo[1,1-biphenyl]-4,4-diyl) bis(2,1-diazenediyl)] bis [3-oxo-, N,N-bis(halo-alkoxy aryl and substituted aryl). |
P-25-0110 | 06/11/2025 | CBI | (G) Ink component | (G) Quino[2,3-b] acridine-7,14-dione, 5,12-dihydro-, (substituted heteropolycyclic) alkyl and sulfo derivs. |
P-25-0111 | 06/12/2025 | CBI | (G) Photoacid generator use at customer sites | (G) Haloaromatic iodonium dicyclo salt with polyfluoroalkyl carbomonocycle hetero acid. |
P-25-0112 | 06/11/2025 | CBI | (G) Additive for use in electronics industry | (G) Haloaromatic iodonium dicyclo salt with halogenated hydroxyaryl carboxylic acid. |
P-25-0113 | 06/11/2025 | Momentive Performance Materials | (S) A co-monomer in acrylic latex production | (G) Siloxanes and Silicones, di-Me, 2-[hydroxy[(2-alkyl-1-oxo-2-propen-1-yl) oxy] cyclohexyl] alkyl group-terminated. |
P-25-0113 | 06/18/2025 | Momentive Performance Materials | (S) A co-monomer in acrylic latex production | (G) Siloxanes and Silicones, di-Me, 2-[hydroxy[(2-alkyl-1-oxo-2-propen-1-yl) oxy] cyclohexyl] alkyl group-terminated. |
P-25-0114 | 06/11/2025 | Greene Tweed & Company | (G) Polymer additive | (G) Carbamic acid, N,N'-(diimino-polyfluoroalkyl)bis-C,C'-bisalkyl ester. |
P-25-0115 | 06/18/2025 | CBI | (G) Deposition material for use in electronics industry | (G) Silylamine. |
P-25-0116 | 06/19/2025 | Heraeus Epurio, LLC | (S) Use as a photoacid generator for photoresist applications | (S) Sulfonium, triphenyl-, salt with tris[(trifluoromethyl)sulfonyl] methane (1:1). |
P-25-0117 | 06/26/2025 | CBI | (G) site-limited intermediate | (G) Amino acid, N, N-bis(cyanoalkyl)-, sodium salt. |
SN-23-0024 | 06/23/2025 | CBI | (G) Component in batteries | (S) Phosphoric acid, iron (2+) lithium salt (1:1:1). |
Table 2 provides non-CBI information on the NOCs received by EPA that have passed an initial screening during this period.
Case No. | Received date | Commencement date | Chemical substance |
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P-12-0106 | 06/16/2025 | 06/04/2025 | (G) Alkyl methacrylate polymer with aromatic vinyl monomer, benzenedicarboxylic acid anhydride and alkyl methacrylates, dialkylalkanate, peroxide-initiated. |
P-15-0138 | 06/10/2025 | 06/05/2025 | (S) Titanium, trichloromethoxy-, (T-4)-. |
P-19-0048 | 06/30/2025 | 06/12/2025 | (S) Poly(oxy-1,2-ethanediyl), -hydro-hydroxy-, mono-C12-14-alkyl ethers, phosphates, sodium salts. |
P-21-0088 | 06/27/2025 | 06/03/2025 | (G) Heterocyclic epoxide polymer with mixed substituted glycols and acid anhydride. |
P-24-0004 | 06/30/2025 | 06/15/2025 | (S) L-Aspartic acid, N-benzoyl-, sodium salt (1:2). |
Table 3 provides non-CBI information on the test information that has been received by EPA that have passed an initial screening during this period.
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Case No. | Received date | Type of test information | Chemical substance |
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P-14-0712 | 06/11/2025 | Polychlorinated Dibenzodioxins and Polychlorinated Dibenzofurans Testing | (G) Plastics, wastes, pyrolyzed, bulk pyrolysate. |
P-14-0712 | 06/12/2025 | Dioxin Report | (G) Plastics, wastes, pyrolyzed, bulk pyrolysate. |
P-21-0202 | 06/11/2025 | Water Solubility (Shake Flask Method) (OECD Test Guideline 105); Partition Coefficient (n-Octanol/Water): Shake Flask Method (OECD Test Guideline 107); Dissociation Constants in Water (Conductometric Method) (OECD Test Guideline 112) | (G) Sulfonium, carbomonocycle bis [(Tri haloalkyl) carbomonocycle], substituted carbomonocyclic ester. |
P-22-0014 | 06/13/2025 | Study Report | (G) Sodium bis(chloropropanediol) phosphate. |
P-22-0014 | 06/27/2025 | Ready Biodegradability (Closed Bottle) (OECD Test Guideline 301D); Freshwater Alga and Cyanobacteria, Growth Inhibition Test (OECD Test Guideline 201) | (G) Sodium bis(chloropropanediol) phosphate. |
P-23-0049 | 06/13/2025 | Water Solubility (Column Elution Method) (OECD Test Guideline 105) | (G) Sulfonium, tricarboxylic-, 2-aryl-polyfluoro polyhydro-alkano-heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-(1,2-diazenediyl) bis[2-methylpropanoate]-initiated. |
P-25-0067 | 06/11/2025 | Water Solubility (Shake Flask Method) (OECD Test Guideline 105); Partition Coefficient (n-Octanol/Water): Shake Flask Method (OECD Test Guideline 107); Dissociation Constants in Water (Conductometric Method) (OECD Test Guideline 112) | (G) Sulfonium, bis (dihalo carbomonocycle) carbomonocycle-, salt with trihalobenzoate. |
P-25-0110 | 06/12/2025 | Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) (OECD Test Guideline 121); Daphnia magna Reproduction Test (OECD Test Guideline 211); in Vitro Mammalian Cell Gene Mutation Test Data; Prenatal Toxicity in Rats Test Data; Repeated Dose 28-day Oral Toxicity Study in Rodents (OECD Test Guideline 407); Melting Point/Melting Range (OECD Test Guideline 102); Boiling Point (OECD Test Guideline 103); Density of Liquids and Solids (OECD Test Guideline 109); Vapour Pressure (OECD Test Guideline 104); Determination of pH, Acidity and Alkalinity (OECD Test Guideline 122); Dissociation Constants in Water (OECD Test Guideline 112); Ready Biodegradability, MITI (I) (Ministry of International Trade and Industry, Japan) (OECD Test Guideline 301C); Ready Biodegradability, CO2 Evolution (Modified Sturm Test) (OECD Test Guideline 301B); Fish Acute Toxicity Test (OECD Test Guideline 203); Daphnia sp. Acute Immobilization Test (OECD Test Guideline 202); Freshwater Alga and Cyanobacteria, Growth Inhibition Test (OECD Test Guideline 201); Activated Sludge, Respiration Inhibition Test (Carbon Ammonium Oxidation) (OECD Test Guideline 209); Acute Oral Toxicity-Acute Toxic Class Method (OECD Test Guideline 423); Acute Dermal Irritation/Corrosion (OECD Test Guideline 404); Acute Eye Irritation/Corrosion (OECD Test Guideline 405); Skin Sensitization, Local Lymph Node Assay: BrdU-ELISA or -FCM (OECD Test Guideline 442B); Bacterial Reverse Mutation Test (OECD Test Guideline 471); in Vitro Mammalian Chromosomal Aberration Test (OECD Test Guideline 473) | (G) Quino[2,3-b] acridine-7,14-dione, 5,12-dihydro-, (substituted heteropolycyclic) alkyl and sulfo derivs. |
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/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices .
Authority: 15 U.S.C. 2601 et seq.
Dated: August 14, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2025-15726 Filed 8-18-25; 8:45 am]
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