BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2024-0057; FRL-11683-06-OCSPP] Certain New Chemicals; Receipt and Status Information for June 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 6/01/2024 to 6/30/2024. DATES: Comments identified by the specific case number provided in this document must be received on or before [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPAHQ-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: TSCAHotline@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 6/01/2024 to 6/30/2024. 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 web site 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 web site at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statuspre-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/tscainventory. 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 nonexempt 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 CDROM 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, in particular, 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 web site 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 web site at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statuspre-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. 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 “1â€, “2â€, “3â€, 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. Table I. – PMN/SNUN/MCANs Approved* from 6/01/2024 to 6/30/2024. Case No. Version Received Date Manufacturer Use Chemical Substance P-220126A 06/07/2024 Takasago (S) This polymer constitutes the wall of microcapsules containing fragrance that can be used in different homecare and personal-care applications (S) Cellulose, polymer with 1,1'-[2-ethyl-2-[(3mercapto-1oxopropoxy)methyl]-1,3propanediyl] bis(3mercaptopropanoate) and 1,2,3-propanetriol bis(2methyl-2-propenoate), peroxydisulfuric acid ([(HO)S(O)2]2O2) ammonium salt (1:2)- and sodium (disulfite) (2:1)initiated P-220149A 06/14/2024 Colonial Chemical, Inc. (S) Hexanoic acid, 3,5,5trimethyl-, sodium salt (1:1) P-230150A 06/19/2024 CBI (S) All-purpose hard surface cleaner, Low foam floor scrubber, Spray Metal Cleaning Concentrate (G) Industrial use for roll-on, brushing, and spray application P-240013A 06/13/2024 Momentive Performance Materials (S) Resin/binder in paint formulations for industrial coatings P-240040A 06/20/2024 Sudoc, LLC P-240083A P-240085A 06/21/2024 CBI 06/04/2024 Luna Labs (G) Additive for commercial, nonspray commercial and consumer applications (G) Ingredient for cleaning products (S) Curative for polyurethane sealant (G) Branched Glycidyl Ester and Bisphenol Glycidyl Ether polymer adduct with Aralkyl Diamine (G) Siloxanes and Silicones, di-Me, hydroxy-terminated, polymers with 3-[[3alkoxy-1(alkoxycarbonyl)-3oxoalkyl]heteroatom] propyl Me silsesquioxanes, alkoxyterminated (G) Metal, aqua[(alkylnitrocarbocycl epolyheteropolyheterocycl opolyalkane-ketone)polyoxidato]-, metal (G) Branched alcohol alkoxylate (S) Siloxanes and Silicones, di-Me, 3-[[[[4[(4isocyanantocyclohexyl)me thyl] cyclohexyl] amino] carbonyl] oxy] propyl group terminated P-240110A 05/31/2024 US Paint Corp. (G) Component of coating P-240114A 05/31/2024 HPC Holdings, (G) Chemical Inc. Intermediate P-240125 P-240128A 04/17/2024 CBI 06/06/2024 CBI P-240132A P-240137 06/11/2024 CBI 04/19/2024 P-240160A 06/05/2024 CBI (G) Photoacid generator use at customer sites P-240163A 06/13/2024 CBI P-240164 06/13/2024 P-240166 06/24/2024 Huntsman International, LLC Nagase America, LLC (G) Gas adsorption cartridges. Protective Garments (S) Intermediate in the production of a catalyst (S) Heat transfer fluid in a cooling system for a reaction chamber (G) Plasticizer Additive (S) Chemical intermediate (G) Sizing agent KAO (G) Component Specialties of liquid Americas, LLC detergent (G) Alkyl fatty acids, polymers with substituted alkene, heteromonocyclic alkenoate, substituted heteropolycyclic, substituted alkyl alkenoate, substituted alkanoic acid, carbomonocyclic dicarboxylic acid, alkyl alkenoate, alkyl alkenoate, alkenoic acid, substituted carbomonocycle, and trisubstituted alkyl, alkyl substituted alkyl alkanoate and substituted bis alkylalkanenitrile-initiated (S) 1,3-Butanediol, 4,4,4trifluoro-3(trifluoromethyl)(G) Dialkyl carbomonocyclodiate (G) Tetramethyldisiloxanediyl bis[propylcarbonyl] (S) Sunflower oil, oleic acid-high, maleated (G) Alkene, reaction products with oxide, hydrolyzed, alkali metal salts (G) Iodonium, bis(dialkyl carbomonocycle) salt with alkyl carbomonocycle hetero-acid (G) Transition metal polykis (heteroatom substituted carbomonocycle), hydroxy- oxo(S) 2-Propanamine, N ,N '-(oxydi-2,1ethanediyl)bis(S) Pentane, 1,1,2,2,3,3,4,4-octafluoro5-(1,1,2,2tetrafluoroethoxy)- In table II 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. Table II—NOCs Approved* From 6/01/2024 to 6/30/2024. Case No. Received Date Commencement Date J-240009 J-240010 J-240011 J-240012 J-240013 P-150446 P-170235 A P-180226 P-190166 A P-220025 06/03/2024 05/30/2024 If amendment, type of amendment N 06/03/2024 05/30/2024 N 06/03/2024 05/30/2024 N 06/03/2024 05/30/2024 N 06/03/2024 05/30/2024 N 06/10/2024 06/05/2024 N 05/31/2024 11/28/2022 05/31/2024 03/04/2024 Amended the generic chemical name N 06/14/2024 06/27/2022 06/19/2024 06/10/2024 Amended the generic chemical name N P-220090 P-220093 06/14/2024 05/21/2024 N 06/03/2024 05/24/2024 N Chemical Substance (G) Chromosomally-modified saccharomyces cerevisiae (G) Chromosomally modified saccharomyces cerevisiae (G) Chromosomally modified saccharomyces cerevisiae (G) Chromosomally-modified saccharomyces cerevisiae (G) Chromosomally-modified saccharomyces cerevisiae (G) Rare earth doped zirconium oxide (G) Fatty amidopropyl trialkyl ammonium alkyl sulfate (G) Trialkylammonioethyl fattyalkylate, alkyl sulfate (G) Triaryl sulfonium, multicycloalkylalkoxycarbonyloxym onofluoroalkylsulfonate (G) Oxirane, 2-(chloromethyl)-, homopolymer, ether with dialkylalkanediol (2:1) (S) 4,8,11-dodecatrienal (G) Alkenoic acid, alkyl-substituted alkyl ester, polymer with (polyalkylamino)alkyl alkylalkenoate, alkyl-substituted alkylalkenoate, alpha-(alkyloxoalkenyl)-omega-alkoxypoly(oxy1,2-ethanediyl), [(alkoxy-alkylalkenyl)oxy]polyalkylsilaneinitiated, compds. with polyethylene glycol phosphoric acid based alkyl ether P-220175 P-871177 06/06/2024 05/23/2024 N 06/20/2024 03/21/1990 N (G) Modified silsesquioxane, alkoxy-terminated (G) Siloxanes and silicones, di-me, vinyl group-terminated, reaction products with trisiladioxadimethoxyalkanes In table III 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. Table III—Test Information Received From 6/01/2024 to 6/30/2024. Case No. L-24-0235 Received Date 06/20/2024 Type of Test Information Bioconcentration Factor Predictions; Bacterial Reverse Mutation Test (OECD Test Guideline 471); Prenatal Developmental Toxicity Study (OECD Test Guideline 414); Carcinogenicity (OECD Test Guideline 451); Acute Dermal Toxicity (OECD Test Guideline 402); Skin Sensitization (OECD Test Guideline 406); Acute Dermal Irritation (OECD Test Guideline 404); Acute Eye Irritation (OECD Test Guideline 405); Chromosomal Aberration Testing Chemical Substance (G) Diisopropyl imidazolium salt P-12-0241 06/21/2024 Analyte Reports P-14-0712 06/27/2024 Polychlorinated Dibenzodioxins and Polychlorinated dibenzofurans Testing P-16-0543 06/25/2024 Exposure Monitoring Report P-21-0166 06/20/2024 Gel Permeation Chromatography Testing (G) [2-Propenoic acid, 2-methyl-, 2hydroxyethyl esters, telomers with c18-26-alkyl acrylate, 1dodecanethiol, N(hydroxymethyl)-2methyl-2propenamide, 3,3,4,4,5,5,6,6,7,7,8 ,8,8tridecaflourooctyl methacrylate, 2,2[1,2 diazenedylbis(1methylethylidene)] bis[4,5-dihydro1Himidazole]hydro chloride (1:2)initiated] (S) Waste plastics, pyrolyzed, C5-55 fraction (G) Halogenophosphori c acid metal salt (G) Siloxanes and silicones, di-me, [alkylpiperaziniumhydroxyalkoxy]alk yl groupterminated, arylsulfonates (salts) P-210180, P22-0086, P-220122, P22-0179, P-220180, P24-0097 6/20/2024 Determination of Dissociation Constant (Conductometric Method) (G) Sulfonium, (halocarbomonocyc le)diphenyl-, salt with 1heterosubstituted-2methylalkyl trihalobenzoate (1:1); (G) Phenoxathiinium, 10-phenyl-, 5-alkyl2-alkyl-4-(2,4,6substituted tricarbopolycycle, heteroacid)benzenesulfon ate (1:1); (G) Heterotrisubstituted -bile acid, 1(difluorosulfomethy l)-2,2,2trifluoroethyl ester, ion(1-), (5)-, 5phenyldibenzothiop henium(1:1); (G) Sulfonium, (alkylsubstitutedph enyl)diphenyl-, salt with 1(heterosubstitutedal kyl)-2,2,2triheterosubstituted alkyl trisubstitutedbenzoa te (1:1); (G) Dibenzothiopheniu m, 5-phenyl-, 4-[1(heterosubstitutedal kyl)-2,2,2triheterosubstituted alkoxy]-4-oxoalkyl trisubstitutedbenzoa te (1:1); (G) Sulfonium, tris(4fluorophenyl)-, (substitutedphenox y)alkyl substitutedbenzoate (1:1) P-210202, P23-0104 06/07/2024 Determination of Water Solubility (Shake Flask Method) P-22-0056 06/25/2024 Determination of Tin in Dermal Penetration Media Samples Validation P-22-0086 06/20/2024 Dissociation Constants in Water (OECD Test Guideline 112) P-22-0122 06/20/2024 Dissociation Constants in Water (OECD Test Guideline 112) (G) Sulfonium, carbomonocycle bis[(trihaloalkyl)car bomonocycle], substituted carbomonocyclic ester; (G) Sulfonium, carbomonocycle bis[(trihaloalkyl)car bomonocycle], disubstituted carbomonocyclic ester (S) Tin, dioctylbis(2,4pentanedionato.kappa.o2,.kappa.o4 )(G) Phenoxathiinium, 10-phenyl-, 5-alkyl2-alkyl-4-(2,4,6substituted tricarbopolycycle, heteroacid)benzenesulfon ate (1:1) (G) Heterotrisubstituted -bile acid, 1(difluorosulfomethy l)-2,2,2trifluoroethyl ester, ion(1-), (5)-, 5phenyldibenzothiop henium(1:1) P-24-0137 04/19/2024 Acute Eye Irritation (OECD Test Guideline 405); Combined Repeated Dose Toxicity with the Reproduction/Development Toxicity Screening Test (OECD Test Guideline 422); Earthworm, Acute Toxicity Tests (OECD Test Guideline 207); Daphnia sp., Acute Immobilization Test (OECD Test Guideline 202); Daphnia magna Reproduction Test (OECD Test Guideline 211); Freshwater and Saltwater Fish Acute Toxicity Test (OECD Test Guideline 203); In Vitro Mammalian Cell Gene Mutation Test (OECD Test Guideline 476); Mammalian Spermatogonial Chromosomal Aberration Test (OECD Test Guideline 483); Prenatal Developmental Toxicity Study (OECD Test Guideline 414); Inherent Biodegradability – Concawe Test (OCSPP Test Guideline 835.3215); Ready Biodegradability (OECD Test Guideline 301); Fish Short-Term Reproduction (OECD Test Guideline 299); Seed Germination/Root Elongation Toxicity Test (OPPTS Test Guideline 850.4200); Sediment-Water Chironomid Toxicity Test Using Spiked Sediment (OECD Test Guideline 218); Skin Sensitization (OECD Test Guideline 406); 90-Day Oral Toxicity in Rodents (OECD Test Guideline 408); Modified Activated Sludge, Respiration Inhibition Test (OCSPP Test Guideline 850.3300); Acute Dermal Irritation (OECD Test Guideline 404); Acute Dermal Toxicity/Pathology (OCSPP Test Guideline 885.3100); Acute Oral Toxicity/Pathogenicity (OCSPP Test Guideline 885.3050); Algal Toxicity (OECD Test Guideline 201); Adsorption/Desorption (Batch Equilibrium) (OECD Test Guideline 106); Bacterial Reverse Mutation Test (OECD Test Guideline 471) (G) Alkene, reaction products with oxide, hydrolyzed, alkali metal salts 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: July 15, 2024. Pamela Myrick, Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics. [FR Doc. 2024-15856 Filed: 7/17/2024 8:45 am; Publication Date: 7/18/2024]