89 FR 243 pgs. 102895-102900 - Certain New Chemicals; Receipt and Status Information for November 2024

Type: NOTICEVolume: 89Number: 243Pages: 102895 - 102900
Docket number: [EPA-HQ-OPPT-2024-0057; FRL-11683-11-OCSPP]
FR document: [FR Doc. 2024-29934 Filed 12-17-24; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version:  PDF Version
Pages: 102895, 102896, 102897, 102898, 102899, 102900

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2024-0057; FRL-11683-11-OCSPP]

Certain New Chemicals; Receipt and Status Information for November 2024

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA Section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; 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 11/01/2024 to 11/30/2024.

DATES:

Comments identified by the specific case number provided in this document must be received on or before January 17, 2025.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2024-0057, through the Federal eRulemaking Portal 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 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.


[top] SUPPLEMENTARY INFORMATION: page 102896

I. Executive Summary

A. What action is the Agency taking?

This document provides the receipt and status reports for the period from 11/01/2024 to 11/30/2024. 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.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 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/chemicals-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

In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the Federal Register after providing notice of such changes to the public and an opportunity to comment (see the Federal Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage of the Lautenberg amendments to TSCA in 2016, public interest in information on the status of section 5 cases under EPA review, and particularly the final determination of such cases, has increased. In an effort to be responsive to the regulated community, the users of this information, and the general public, to comply with the requirements of TSCA, to conserve EPA resources and to streamline the process and make it more timely, EPA is 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.

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.


[top] 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 page 102897 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.

page 102898


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Case No. Version Received date Manufacturer Use Chemical substance
J-25-0001 1 11/13/2024 CBI (G) Ethanol production (G) Biofuel producing Saccharomyces cerevisiae modified, genetically stable.
P-21-0007A 3 11/06/2024 CBI (G) Catalyst (G) Reaction products of Aluminoxanes, Me, Me group-terminated and (alkylcycloalkylene)dialkylzirconium.
P-21-0008A 3 11/06/2024 CBI (G) Catalyst (G) Reaction products of Aluminoxanes, Me, Me group-terminated and cycloalkylene dialkyl tetrahydro indenyl zirconium.
P-22-0158A 5 11/19/2024 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-23-0141A 2 11/21/2024 Hach Company (G) Buffer solution for free chlorine determination (S) 2-Butenedioic acid (2Z)-, potassium salt (1:?).
P-24-0046A 2 11/20/2024 The Euclid Chemical Company (S) Grinding aid used in cement manufacture (G) Alkanol, alkoxyalkyl imino, salt.
P-24-0047A 2 11/20/2024 The Euclid Chemical Company (S) Grinding aid used in cement manufacture (G) Alkanol, nitrilo, salt.
P-24-0116A 4 11/20/2024 CBI (G) For use in coatings for metal parts (G) Phenol, 4,4-(1-alkylidene) bis-, polymer with 2-(chloromethyl) oxirane, 4-alkylphenyl ether, reaction products with alkylpolyamine and 2-(alkylamino)alkanol, hydrolyzed, alkanesulfonates (salts).
P-24-0117A 4 11/20/2024 CBI (G) For use in coatings for metal parts (G) Alkanoic acid, compds. with hydrolyzed bisphenol-epichlorohydrin polymer 4-alkylphenyl ether- alkylpolyamine and 2-(alkylamino)alkanol reaction products.
P-24-0118A 4 11/20/2024 CBI (G) For use in coatings for metal parts (G) Alkanoic acid, compds. with [(aminoalkyl)imino] bis[alkanol]-bisphenol-epichlorohydrin polymer 4-alkylphenyl ether-2-(alkylamino)alkanol reaction products.
P-24-0119A 4 11/20/2024 CBI (G) For use in coatings for metal parts (G) Amidosulfonic acid, compds. With [(aminoalkyl)imino] bis[alkanol]-bisphenol-epichlorohydrin polymer 4-alkylphenyl ether-2-(alkylamino)alkanol reaction products.
P-24-0120A 4 11/20/2024 CBI (G) For use in coatings for metal parts (G) Alkanoic acid, compds. with hydrolyzed bisphenol-monoalkylamine-epichlorohydrin polymer 4-alkylphenyl ether- alkylpolyamine and 2-(alkylamino)alkanol reaction products.
P-24-0121A 4 11/20/2024 CBI (G) For use in coatings for metal parts (G) Phenol, 4,4-(1-alkylidene) bis-, polymer with 2-(chloromethyl) oxirane and monoalkanamine, 4-alkylphenyl ether, reaction products with alkylpolyamine and 2-(alkylamino)alkanol, hydrolyzed, alkanesulfonates (salts).
P-25-0005A 2 11/20/2024 CBI (G) For use in coatings for metal parts (G) Cashew, nutshell liq., polymer with [(aminoalkyl)imino] bis[alkanol], bisphenol and epichlorohydrin, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts).
P-25-0006A 2 11/20/2024 CBI (G) For use in coatings for metal parts (G) Phenol, 4,4-(1-alkylidene) bis-, polymer with [(aminoalkyl)imino] bis[alkanol] and 2-(chloromethyl) oxirane, 3-alkyloxy-2-hydroxypropyl ethers, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts).
P-25-0007A 2 11/20/2024 CBI (G) For use in coatings for metal parts (G) Phenol, 4,4-(1-alkylidene) bis-, polymer with [(aminoalkyl)imino] bis[alkanol] and 2-(chloromethyl) oxirane, 4-alkylphenyl ethers, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts).
P-25-0008A 2 11/20/2024 CBI (G) For use in coatings for metal parts (G) Benzenediol, polymer with [(aminoalkyl)imino] bis[alkanol], 2- (chloromethyl)oxirane and 4,4-(1-alkylidene) bis[phenol], 4-alkylphenyl ethers, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts).
P-25-0009A 2 11/20/2024 CBI (G) For use in coatings for metal parts (G) Cashew, nutshell liq., polymer with [(aminoalkyl)imino] bis[alkanol], bisphenol, epichlorohydrin and benzenediol, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts).
P-25-0010A 2 11/20/2024 CBI (G) For use in coatings for metal parts (G) Benzenediol, polymer with [(aminoalkyl)imino] bis[alkanol], 2- (chloromethyl)oxirane and 4,4-(1-alkylidene) bis[phenol], 3-alkyloxy-2-hydroxypropyl ethers, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts).
P-25-0011A 3 11/01/2024 CBI G (Surface Modifier) (G) Phosphonic acid, P- [polyfluoro- oxygen-substituted-poly(trifluoromethyl)-heteroatom-substituted-alkan-1-yl]-.
P-25-0011A 4 11/20/2024 CBI (G) Surface Modifier (G) Phosphonic acid, P- [polyfluoro- oxygen-substituted-poly(trifluoromethyl)-heteroatom-substituted-alkan-1-yl]-.
P-25-0015 1 11/12/2024 CBI (G) Additive in paving applications (G) Modified tall oil fatty acid polyamine condensate.
P-25-0016 1 11/15/2024 CBI (G) Photoacid generator use at customer sites (G) Tri haloaromatic iodonium dicyclo salt with polyhaloalkyl carbomonocycle hetero acid.
P-25-0017 2 11/26/2024 US Polymers Accurez, LLC (S) Binder for Thermoplastic Coatings; Binder for Ink/Adhesive (G) Reaction product of aromatic acid with trifunctional polyol and pelargonic acid.
P-25-0020 1 11/21/2024 CBI (G) Contained use for microlithography for electronic device manufacturing (G) Sulfonium, triphenyl-, salt with heterosubstituteddifluorosubstitutedalkyl substitutedalkyl trihalosubstitutedcarbomonocycle carboxylate (1:1).
P-25-0021 1 11/22/2024 CBI (G) Contained use for microlithography for electronic device manufacturing (G) Sulfonium, tri (halosubstituted henyl)-, salt with heterosubstituteddifluorosubstitutedalkyl substitutedalkyl trihalosubstitutedcarbomonocycle carboxylate (1:1).
SN-23-0024A 2 11/21/2024 CBI (G) Component in batteries (S) Phosphoric acid, iron (2+) lithium salt (1:1:1).
SN-25-0002 1 11/20/2024 CBI (G) Additive used in plastic panels (S) Cesium tungsten oxide.
SN-25-0003 1 11/25/2024 CBI (S) Cathode Active Material in Batteries (S) Phosphoric acid, iron (2+) lithium salt (1:1:1).



[top] In Table II. of this unit, EPA provides the following information (to the extent that such information is not subject to a CBI claim) on the TMEs and/or Biotech Exemptions received by EPA during this period: The EPA case number assigned to the TME and/or Biotech Exemption, the submission document type (initial or amended), the version number, the date the TME and/or Biotech Exemption was received by EPA, the submitting manufacturer ( i.e., domestic producer or importer), the potential uses identified by the manufacturer in the TME and/or Biotech Exemption, and the chemical substance identity. page 102899

Case No. Submission type Version Received date Manufacturer Use Chemical substance
T-24-0001A Test Marketing Exemption Application (TMEA)Test Marketing Exemption Application (TMEA) 4 11/18/2024 Zschimmer & Schwarz (S) Raw material in ester manufacturing, to be fully consumed (G) Isomerized alkane derivs.

In Table III 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 of the type of amendment ( e.g., amendment to generic name, specific name, technical contact information, etc.) and chemical substance identity.

Case No. Received date Commencement date If amendment, type of amendment Chemical substance
J-20-0013 11/08/2024 12/21/2023 N (G) Strain of Escherichia coli modified with genetically stable, plasmid-borne DNA to produce enzymes.
J-20-0014 11/13/2024 12/21/2023 N (G) Strains of Escherichia coli modified with genetically stable, plasmid-borne DNA to produce enzymes.
J-20-0015 11/13/2024 12/21/2023 N (G) Strain of Escherichia coli modified with genetically stable, plasmid-borne DNA to produce enzymes.
J-20-0016 11/13/2024 12/21/2023 N (G) Strain of Escherichia coli modified with genetically stable, plasmid-borne DNA to produce enzymes.
J-20-0017 11/13/2024 12/21/2023 N (G) Strain of Escherichia coli modified with genetically stable, plasmid-borne DNA to produce enzymes.
J-20-0018 11/13/2024 12/21/2023 N (G) Strain of Escherichia coli modified with genetically stable, plasmid-borne DNA to produce enzymes.
J-21-0019 11/13/2024 12/21/2023 N (G) Strain of Escherichia coli modified with genetically stable, plasmid-borne DNA to produce plasmid-borne DNA.
P-13-0143 11/15/2024 03/10/2013 N (G) Polyalkylene acid, alkanol amine derivative.
P-15-0680A 11/19/2024 05/14/2018 N (S) 2-propenoic acid, butylester, polymer with 1,3-cyclohexanedimethanamine, reaction products with Bu glycidyl ether.
P-18-0226A 11/01/2024 03/04/2024 N (G) Trialkylammonioethyl fatty-alkylate, alkyl sulfate.
P-20-0156 11/11/2024 10/16/2024 N (G) Substituted, triaryl-, Tri cycloalkane alkyl disubstituted.
P-21-0055A 11/25/2024 07/07/2022 Amended generic chemical name (G) Fatty acids, reaction products with dialkenyltriamine-aromatic dicarboxylic acid polymer and polycyclic acids.
P-21-0066 11/12/2024 10/23/2024 N (G) 1,2-Alkanediol, 3-aryloxy, mono phosphate ester.
P-22-0154 11/19/2024 11/15/2024 N (S) 2-tridecenoic acid, 2-acetyl-4-methyl-, ethyl ester.
P-22-0175A 11/26/2024 05/22/2024 Relinquished chemical identity confidentiality claim (S) Silsesquioxanes, Me vinyl, hydroxy and methoxy and [(trimethylsilyl)oxy]- terminated.
P-23-0069 11/01/2024 10/21/2024 N (S) Oils, Pisum sativum, polymers with 1, 6-diisocyanatohexane, 1,5 diisocyanato pentane, glycerol, and maltodextrin.
P-23-0101 11/19/2024 10/31/2024 N (G) Glycerides from fermentation of genetically modified microorganism, epoxidized.
P-23-0103 11/19/2024 10/31/2024 N (G) Glycerides from fermentation of genetically modified microorganism, epoxidized, reaction products with ethanol.
P-23-0152 11/11/2024 10/17/2024 N (G) 1-Alkanethiol, 3-(trialkoxysilyl)- hydrolysis products with silica, oxidized.
P-23-0174 11/15/2024 11/07/2024 N (G) Mixed metal oxide.
P-23-0188 11/25/2024 11/15/2024 N (G) Alkenoic acid, 3-methyl-, 1,1-dimethyl-2-propen-1-yl ester.
P-24-0088 11/04/2024 10/07/2024 N (G) Mixed metal oxide.

In Table IV 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-16-0543 11/19/2024 Exposure Monitoring Report (G) Halogenophosphoric acid metal salt.
P-22-0056 11/09/2024 In Vitro Percutaneous Absorption of Tin in a Sealant Formulation Through Human Skin; In Vitro Percutaneous Absorption of Radiolabeled TIB KAT 223 in Sealant Formulation Through Human Split-Thickness Skin; Supplementary risk assessment for industrial handling of TIB KAT 223 and consumer use of sealants formulated with TIB KAT 223; initial review engineering report; CEM Inhalation and Dermal Exposure Estimates (S) Tin, dioctylbis (2,4-pentanedionato-. kappa. O2,. kappa. O4)-.


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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: December 12, 2024.

Pamela Myrick,

Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.

[FR Doc. 2024-29934 Filed 12-17-24; 8:45 am]

BILLING CODE 6560-50-P