90 FR 35 pgs. 10492-10496 - Certain New Chemicals; Receipt and Status Information for January 2025
Type: NOTICEVolume: 90Number: 35Pages: 10492 - 10496
Pages: 10492, 10493, 10494, 10496Docket number: [EPA-HQ-OPPT-2025-0067; FRL-12475-01-OCSPP]
FR document: [FR Doc. 2025-02995 Filed 2-21-25; 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-12475-01-OCSPP]
Certain New Chemicals; Receipt and Status Information for January 2025
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice and request for comment.
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: 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. 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.
[top] Any person who intends to manufacture (including import) a new
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.
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| Case No. | Version | Received date | Manufacturer | Use | Chemical substance |
|---|---|---|---|---|---|
| J-25-0004A | 2 | 01/14/2025 | CBI | (G) Manufacture of an alcohol | (G) Modified Yeast, with chromosomal modifications to improve fermentation characteristics. |
| J-25-0005A | 2 | 01/14/2025 | CBI | (G) Manufacture of an alcohol | (G) Modified Yeast, with chromosomal modifications to improve fermentation characteristics. |
| P-23-0070A | 5 | 01/22/2025 | CBI | (G) Surfactant for cleaning products, pet shampoo, hand cleansing, laundry detergent and dishwasher detergent | (S) Fatty Acids, C8-14, methyl-2-sulfoethyl esters, sodium salts. |
| P-23-0192A | 2 | 01/27/2025 | Colonial Chemical, Inc | (S) Metal working applications | (G) Amides, fatty acid, N, N-bis(2-hydroxypropyl). |
| P-24-0034A | 2 | 01/17/2025 | Barentz North America, LLC | (S) 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). 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 | (S) 2,5,7,10-Tetraoxaundecane, 4,8-dimethyl-. |
| 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 fluid, Dielectric testing | (G) Trimers of hexafluoropropene. |
| P-25-0019A | 2 | 01/24/2025 | Cytec Industries, Inc | (G) Additive used in acid production | (G) Dithiophosphate alkyl ester salt. |
| P-25-0038A | 3 | 01/28/2025 | CBI | (S) Used in automotive safety air bag inflators | (S) 1,3,5-Triazine-2,4,6-triamine, nitrate (1:1). |
| P-25-0040A | 2 | 01/22/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Gases, processed. |
| P-25-0041A | 2 | 01/09/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0041A | 3 | 01/16/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0041A | 4 | 01/23/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0042A | 2 | 01/09/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0042A | 3 | 01/16/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0042A | 4 | 01/23/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0043A | 2 | 01/09/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0043A | 3 | 01/16/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0043A | 4 | 01/23/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0044A | 2 | 01/09/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0044A | 3 | 01/16/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0044A | 4 | 01/23/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0045A | 2 | 01/09/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbons, carbon range. |
| P-25-0045A | 3 | 01/16/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbons, carbon range. |
| P-25-0045A | 4 | 01/23/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbons, carbon range. |
| P-25-0046A | 2 | 01/16/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0046A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0047A | 2 | 01/16/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0047A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0048A | 2 | 01/16/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0048A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0049A | 2 | 01/16/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0049A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0050A | 2 | 01/16/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses, Intermediate | (G) Hydrocarbon, processed. |
| P-25-0050A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses, Intermediate | (G) Hydrocarbon, processed. |
| P-25-0051A | 2 | 01/16/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0051A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Additive for consumer, commercial, and industrial uses | (G) Hydrocarbon, processed. |
| P-25-0052A | 2 | 01/15/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0052A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0053A | 2 | 01/15/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0053A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0054A | 2 | 01/15/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0054A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0055A | 2 | 01/15/2025 | Motiva Enterprises, LLC | (G) Additive used in industrial and commercial applications | (G) Hydrocarbon, processed. |
| P-25-0055A | 3 | 01/24/2025 | Motiva Enterprises, LLC | (G) Additive used in industrial and commercial applications | (G) Hydrocarbon, processed. |
| P-25-0056A | 2 | 01/15/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0056A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0057A | 2 | 01/15/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0057A | 3 | 01/23/2025 | Motiva Enterprises, LLC | (G) Intermediate | (G) Hydrocarbon, processed. |
| P-25-0058 | 1 | 01/02/2025 | CBI | (G) Component of cleaner | (G) Heteromonocycle alkanol, homopolymer, monoalkyl ether. |
| P-25-0059 | 1 | 01/21/2025 | CBI | (S) Treatment agent for pigments. | (G) Benzamide, alkoxy-[[[[(alkoxyphenyl)amino] carbonyl]-oxoalkyl] diazenyl]-N-phenyl-. |
| P-25-0060A | 2 | 01/28/2025 | CBI | (G) Contained use for microlithography for electronic device manufacturing | (G) Dibenz thiophenium, 5-phenyl-, salt with fluoroheterosubstitutedalkyl heterosubstitutedhalosubstitutedaromatichydrocarboncarboxylate (1:1), polymer with 3-ethenylphenol and fluorocarbomonocyclealkyl 2-methyl-2-propenoate. |
| SN-25-0004A | 2 | 01/03/2025 | CBI | (G) Formulation into cosmetic products, Use as monomer in polymer industry | (S) 1,3-Butanediol, (3R)-. |
| *?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.
| Case No. | Received date | Commencement date | If amendment, type of amendment | Chemical substance |
|---|---|---|---|---|
| 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. |
| *?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.
| Case No. | Received date | Type of test information | Chemical substance |
|---|---|---|---|
| P-09-0644 | 01/08/2025 | Annual PFAS Species Testing | (G) Substituted alkyl phosphate ester. |
| P-09-0645 | 01/08/2025 | Annual PFAS Species Testing | (G) Substituted 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 test data on pH treated Melamine nitrate; Fish acute toxicity data on Melamine nitrate; pH treated Melamine nitrate process and chemical analysis | (G) Melamine nitrate. |
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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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