90 FR 158 pgs. 40355-40359 - Certain New Chemicals; Receipt and Status Information for May 2025
Type: NOTICEVolume: 90Number: 158Pages: 40355 - 40359
Pages: 40355, 40356, 40357, 40358, 40359Docket number: [EPA-HQ-OPPT-2025-0067; FRL-12475-05-OCSPP]
FR document: [FR Doc. 2025-15724 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-12475-05-OCSPP]
Certain New Chemicals; Receipt and Status Information for May 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 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?
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 applications received; the date of
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 |
|---|---|---|---|---|
| J-25-0006 | 04/29/2025 | CBI | (G) Chemical Production | (G) Chromosomally modified Saccharomyces cerevisiae. |
| J-25-0007 | 04/29/2025 | CBI | (G) Chemical Production | (G) Chromosomally modified Saccharomyces cerevisiae. |
| J-25-0008 | 04/29/2025 | CBI | (G) Chemical Production | (G) Chromosomally modified Saccharomyces cerevisiae. |
| J-25-0009 | 04/29/2025 | CBI | (G) Chemical Production | (G) Chromosomally modified Saccharomyces cerevisiae. |
| J-25-0010 | 04/29/2025 | CBI | (G) Chemical Production | (G) Chromosomally modified Saccharomyces cerevisiae. |
| P-22-0014 | 04/01/2025 | CBI | (G) precursor | (G) Sodium bis(chloropropanediol) phosphate. |
| P-23-0162 | 05/02/2025 | CBI | (S) Transportation fuels, Chemical Feedstock, Fuel additive | (G) Alkane (glyceridic), hydrotreated and isomerized. |
| P-24-0093 | 05/01/2025 | Evonik Corporation | (S) Surfactant in laundry detergent, surfactant in manual/hand dish detergent, surfactant in hard surface cleaner | (G) Rhamnolipids, modified pseudomonas-fermented, from dextrose, salts. |
| P-24-0094 | 05/01/2025 | Evonik Corporation | (S) Surfactant in laundry detergent, surfactant in manual/hand dish detergent, surfactant in hard surface cleaner | (G) Rhamnolipids, modified pseudomonas-fermented, from dextrose, salts. |
| P-24-0095 | 05/01/2025 | Evonik Corporation | (S) Surfactant in laundry detergent, surfactant in manual/hand dish detergent, surfactant in hard surface cleaner | (G) Rhamnolipids, modified pseudomonas-fermented, from dextrose, salts. |
| P-24-0096 | 05/01/2025 | Evonik Corporation | (S) Surfactant in laundry detergent, surfactant in manual/hand dish detergent, surfactant in hard surface cleaner | (G) Rhamnolipids, modified pseudomonas-fermented, from dextrose, salts. |
| P-24-0112 | 04/25/2025 | CBI | (S) Rubber accelerator for the manufacture of rubber articles | (S) CARBAMODITHIOIC ACID, N, N-BIS(PHENYLMETHYL)-, COMPD. WITH 2,2'-DITHIOBIS[ETHANAMINE] (2:1). |
| P-24-0136 | 05/22/2025 | CBI | (G) Crosslinking polymer | (G) Siloxanes and Silicones, di-Me, polymers with silicic acid, [(ethenyldimethylsilyl)oxyl]-terminated, reaction products with [(alkoxysilyl)ethyl] siloxane and [(alkoxysilyl)ethyl] siloxane. |
| P-24-0179 | 05/12/2025 | CBI | (G) Component in batteries | (G) Aluminum- and metal-doped cobalt metal nickel oxide. |
| P-24-0180 | 05/12/2025 | CBI | (G) Component in batteries | (G) Aluminum- and metal- and metal-doped cobalt metal nickel oxide. |
| P-24-0181 | 05/12/2025 | CBI | (G) Component in batteries | (G) Metal- and metal-doped cobalt metal metal nickel oxide. |
| P-24-0195 | 05/12/2025 | CBI | (G) Dielectric testing, Heat transfer fluid | (G) Trimers of hexafluoropropene. |
| P-25-0023 | 11/26/2024 | CBI | (G) Mixed metal oxide for batteries | (G) Cobalt lithium manganese nickel oxide, metals-modified. |
| P-25-0065 | 04/29/2025 | Itaconix Corp | (S) Chemical intermediate in polymer production | (S) Butanedioic acid, 2-methylene-, 1,4-dimethyl ester. |
| P-25-0068 | 05/16/2025 | Cytec Industries Inc | (G) Additive used in phosphoric acid production | (G) ether modified polyethyleneimine polymer. |
| P-25-0072 | 05/12/2025 | CBI | (G) Heat transfer fluid, Dielectric testing | (G) 1-Propene, polyfluoro-, trimer, epoxidized. |
| P-25-0081 | 05/01/2025 | CBI | (S) Treatment agent for pigments | (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-25-0082 | 05/01/2025 | CBI | (S) Treatment agent for pigments | (G) Alkanamide, [alkanediylbis(oxy-arylene-diazenediyl)] bis [3-oxo-, N,N'-bis(heterocyclic-substituted aryl and substituted aryl). |
| P-25-0083 | 05/02/2025 | CBI | (G) Pigment | (G) Metal, Transitional Metals, oxide. |
| P-25-0084 | 05/21/2025 | CBI | (G) Component in cooling formulations | (G) Alkoxy 1H-Benzimidazole. |
| P-25-0085 | 05/06/2025 | Clariant Corporation | (S) Stain and soil release agent for use in laundry detergents | (G) Arylcarboxylic acid, polymer with alkanol, ester with substituted polyalkylene glycol. |
| P-25-0086 | 05/06/2025 | Clariant Corporation | (S) Stain and soil release agent for use in laundry detergents | (G) Polymer of arylcarboxylic acid, glycol, polyalkylene glycol ether. |
| P-25-0087 | 05/06/2025 | Clariant Corporation | (S) Stain and soil release agent for use in laundry detergents | (G) Polymer of arylcarboxylic acid, alkanediol and alcohols, alkoxylated. |
| P-25-0088 | 05/06/2025 | Clariant Corporation | (S) Stain and soil release agent for use in laundry detergents | (G) Polymer of arylcarboxylic acid, glycols and polyalkylene glycol ether. |
| P-25-0089 | 05/06/2025 | Clariant Corporation | (S) Stain and soil release agent for use in laundry detergents | (G) Polymer of arylcarboxylic acid, sulfoarylcarboxylic acid, alkyl ester salt, glycols and oligoethylene glycol ether. |
| P-25-0090 | 05/08/2025 | CBI | (G) monomer for use in UV/EB technology | (G) Carbamic acid, N,N'-(trialkylalkanidyl)bis-, bis(propenyloxy)alkyl ester. |
| P-25-0091 | 05/08/2025 | CBI | (G) Carbamic acid, N,N'-(trialkylalkanidyl)bis-, bis(propenyloxy)alkyl ester. | |
| P-25-0092 | 05/16/2025 | CBMM | (S) The substance is an anode active material used in batteries and accumulators, which are intended for industrial use such as trucks and various commercial vehicles | (G) Niobium zinc oxide, mixed transition metal doped. |
| P-25-0092 | 05/22/2025 | CBMM | (S) The substance is an anode active material used in batteries and accumulators, which are intended for industrial use such as trucks and various commercial vehicles | (G) Niobium zinc oxide, mixed transition metal doped. |
| P-25-0097 | 05/13/2025 | CBI | (S) Export formulated for use outside of US, (G) Photoacid generator use at customer sites | (G) Aromatic sulfonium tricyclo salt with dicycloalkyl carbomonocycle hetero acid. |
| P-25-0099 | 05/22/2025 | CBI | (G) Photolithography | (G) Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-polyfluoropolyhydro-2-alkyl-2-((halocarbomonocyclic)alkano)-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1). |
| P-25-0101 | 05/23/2025 | Cargill, Incorporated | (S) Thickener or additive to improve lubrication performance for industrial gear oils and hydraulic fluid applications; Thickener or additive to improve lubrication performance for applications in stern tube lubricants and gear oils for ships | (G) Alkanedioic acid, polymer with polyhydroxyalkane, branched alkanoate. |
| P-25-0102 | 05/27/2025 | CBI | (S) Export for use outside of US, (G) Photoacid generator use at customer sites | (G) Carboheterocyclo aromatic sulfonium salt with dicycloalkyl carbomonocycle hetero acid. |
| P-25-0103 | 05/28/2025 | CBI | (G) Component of photoresist | (G) Alkanedioic acid, polyhalo, carbomonocycle [[(alkyl-substituted alkenyl) substituted] alkyl] ester, homopolymer. |
| P-25-0104 | 05/28/2025 | CBI | (G) Component of photoresist | (G) Alkyl alkenoic acid, substituted heteropolycyclic substituted alkyl ester, polymer with substituted carbopolycyclic, alkyl alkenoate, alkyl carbopolycyclic alkyl alkenoate and heteromonocyclic alkyl alkenoate. |
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 |
|---|---|---|---|
| P-18-0413 | 05/20/2025 | 04/25/2025 | (S) Ethanol, 2,2-difluoro-, 1-acetate. |
| P-21-0083 | 05/01/2025 | 04/25/2025 | (G) Alkenoic acid, reaction products with pentaerythritol, polymers with diisocyanatoalkane and heteromonocyle homopolymer esters with alkanoic acid-pentaerythritol reaction products. |
| P-23-0088 | 05/28/2025 | 05/13/2025 | (S) Glycine, reaction products with oxidized maltodextrin. |
| P-23-0089 | 05/28/2025 | 05/14/2025 | (S) Maltodextrin, 6-[3-(dimethyl-2-propen-1-ylammonio) propyl] ether, chloride. |
| P-23-0090 | 05/28/2025 | 05/15/2025 | (S) Dextran, 3-(dimethyl-2-propen-1-ylammonio) propyl ether, chloride. |
| P-23-0091 | 05/28/2025 | 05/14/2025 | (S) Maltodextrin, oxidized, reaction products with ethylenediamine. |
| P-24-0085 | 05/22/2025 | 05/15/2025 | (G) GlassLock Sealant Part B. |
| P-24-0124 | 05/16/2025 | 04/19/2025 | (G) Alkyl alkenoic acid, alkyl ester, polymer with substituted carbomonocycle, substituted alkyl alkyl alkenoate phosphate, substituted alkyl alkyl alkenoate, alkyl alkenoate, heteromonocycle polymer, substitutes alkenyl substituted alkyl ester, alkyl substituted alkyl alkanoate initiated. |
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 |
|---|---|---|---|
| P-14-0712 | 05/21/2025 | Polychlorinated Dibenzodioxins and Polychlorinated dibenzofurans Testing | (S) Waste plastics, pyrolyzed, C5-55 fraction. |
| P-14-0712 | 5/26/2025 | Polychlorinated Dibenzodioxins and Polychlorinated dibenzofurans Testing | (S) Waste plastics, pyrolyzed, C5-55 fraction. |
| P-16-0543 | 05/12/2025 | Exposure Monitoring Report | (G) Halogenophosphoric acid metal salt. |
| P-17-0178 | 04/25/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Sulfonium, triphenyl-, salt with substituted-alkyl 4-substituted-benzoate. |
| P-18-0013 | 04/25/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Sulfonium, pheno carbopolycycle, inner salt. |
| P-18-0014 | 04/25/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Sulfonium, triphenyl-, salt with disubstituted-heterocyclic compound (1:1). |
| P-18-0037 | 04/25/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Sulfonium, triphenyl-, salt with 2,4,5-trisubstituted-benzenesulfonate (1:1). |
| P-18-0304 | 04/28/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Sulfonium, bis (dihalo carbomonocycle) carbomonocycle, salt with substituted heteropolycycle dihalo sulfo alkanoate (1:1). |
| P-18-0316 | 04/28/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Heteropolycycle, alkylaromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate. |
| P-18-0338 | 04/28/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl polycarbocyclic alkane-1-carboxylate (1:1). |
| P-19-0076 | 04/28/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Sulfonium, bis (dihalo carbomonocycle) carbomonocycle, salt with dihalo substituted alkyl carbopolycyclic carboxylate (1:1). |
| P-19-0115 | 04/28/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Sulfonium, bis (dihalo carbomonocycle) carbomonocycle, substituted carbomonocyclic ester. |
| P-19-0142 | 04/28/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Heteropolycycle, aromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (1:1). |
| P-19-0166 | 04/25/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Triaryl sulfonium, multicycloalkylalkoxycarbonyloxymonofluoroalkylsulfonate. |
| P-20-0120 | 04/28/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Carbomonocyclic sulfonium, salt with trihalo-sulfoalkyl hydroxycarbopolycyclic carboxylate. |
| P-20-0140 | 04/25/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) N-Substituted-beta-alanine, heterosubstituted-alkyl ester, ion (1-), triphenylsulfonium (1:1). |
| P-21-0027 | 04/28/2025 | Photo transformation of Chemicals in Water-Direct Photolysis (OECD Test Guideline 316) | (G) Heteropolycyclic, Tri haloalkyl carbomonocycle-, hydroxy carbomonocyclic salt. |
| P-22-0042 | 05/09/2025 | Prenatal Developmental Toxicity Study (OECD Test Guideline 414) | (G) Alkanediones, [[[(substituted)aryl] thio] aryl]-, 2-(O-acetyloxime). |
| P-23-0163 | 05/16/2025 | Wastewater Treatment Study | (S) 1,2-Ethanediamine, N1-[3-(trimethoxysilyl) propyl]-, hydrolysis products with 3-(trimethoxysilyl)-N- [3- (trimethoxysilyl)propyl]-1-propanamine, nitrates (salts). |
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. 2025-15724 Filed 8-18-25; 8:45 am]
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