[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)] [Notices] [Pages 80294-80298] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2023-25437] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2023-0061; FRL-10581-10-OCSPP] Certain New Chemicals; Receipt and Status Information for October 2023 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 10/01/ 2023 to 10/31/2023. DATES: Comments identified by the specific case number provided in this document must be received on or before December 18, 2023. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2023-0061, 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/. 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: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. Executive Summary A. What action is the Agency taking? This document provides the receipt and status reports for the period from 10/01/2023 to 10/31/2023. 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 [[Page 80295]] 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, 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 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. 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. Table I--PMN/SNUN/MCANs Approved* From 10/01/2023 to 10/31/2023 ---------------------------------------------------------------------------------------------------------------- Received Case No. Version date Manufacturer Use Chemical substance ---------------------------------------------------------------------------------------------------------------- P-21-0165A............. 3 10/23/2023 Colonial (S) Anionic (S) D-Glucopyranose, Chemical, Inc. surfactant in oligomeric, C10-16-alkyl cleaning glycosides, 3-(3,4- products. dicarboxy-3-hydroxy-1- oxobutoxy)-2- hydroxypropyl ethers, sodium salts. P-22-0023A............. 2 09/28/2023 CBI.............. (G) Catalyst (G) Alkyldioic acid, system component. bis(alkylalkyl)-, polyalkyl ester. P-22-0023A............. 3 10/13/2023 CBI.............. (G) Catalyst (G) Alkyldioic acid, system component. bis(alkylalkyl)-, polyalkyl ester. P-22-0040A............. 4 10/16/2023 CBI.............. (G) Component (S) Manganate(4-), used in hexakis(cyano-.kappa.C)-, manufacture of manganese (2+) sodium, high- (OC-6-11)-. performance batteries. P-22-0041A............. 4 10/16/2023 CBI.............. (G) A component (S) Ferrate (-4), used in the hexakis(cyano-.kappa.C)-, manufacture of iron(3+) manganese(2+) batteries. sodium, (OC-6-11)-. P-22-0168A............. 4 10/11/2023 Colonial (S) The product (G) Amides, alkyl, N-[3- Chemical, Inc. is used as a (dimethylamino)propyl]. reaction intermediate to make surfactant end-products. It is not sold commercially or used outside of our manufacturing facility.. [[Page 80296]] P-23-0134A............. 4 10/11/2023 CBI.............. (G) (S) Poly[oxy(methyl-1,2- Photoinitiator ethanediyl)],alpha-hydro- for UV curing of omega-{[2-[(1-chloro-9- monomeric and oxo-9H-thioxanthen-4- oligomeric yl)oxy]acetyl]oxy{time} - acrylate-based ,ether with 2,2- printing inks. bis(hydroxymethyl)-1,3- propanediol (4:1). P-23-0154A............. 4 10/04/2023 RWDC Industries.. (G) The primary (G) Vegetable oils, application genetically modified areas for PHA Cupriavidus-fermented, are for food polyhydroxyalkanoate packaging and copolymer. other uses where its biodegradable properties provide nontraditional end-of-use options. P-23-0165A............. 4 09/29/2023 CBI.............. (G) Production (G) 2,3,3,3-tetrafluoro-2- aide for the [(polyfluoroalken-1- manufacturing of yl)oxy]-propanoic acid polymers. homopolymer. P-23-0168A............. 3 10/13/2023 Central Glass (G) Battery (G) Sulfamoyl halide International, production. fluorophosphate salt. Inc. P-23-0192.............. 1 09/27/2023 Colonial (S) Metal working (G) Amides, fatty acid, Chemical, Inc. applications. N,N-bis(2-hydroxypropyl). P-23-0193.............. 1 09/27/2023 CBI.............. (G) Component of (G) Substituted lenses used in carbopolycyclic electronic dicarboxylic acid dialkyl applications. ester, polymer with alkanediol, carbopolycyclic bis(substituted carbopolycycle)bis[alkano l] and carbopolycyclic bis(substituted carbomonocycle)bis[alkano l]. P-23-0194.............. 1 09/29/2023 CBI.............. (G) Lubricant (G) Amines, alkyl and additive. alkenyl, 2-ethylhexyl phosphates. P-24-0004.............. 1 10/05/2023 CBI.............. (G) Plastic (G) Benzoylated amino acid production aid. salt. P-24-0005.............. 3 10/24/2023 CBI.............. (G) Plastic (G) Polycarbomonocyclic article diol reaction products production. with cycloalkylcarbomonocycle and polysubstituted heteromonocycle. P-24-0005A............. 4 10/25/2023 CBI.............. (G) Plastic (G) Polycarbomonocyclic article diol reaction products production. with cycloalkylcarbomonocycle and polysubstituted heteromonocycle. P-24-0005A............. 5 10/25/2023 CBI.............. (G) Plastic (G) Polycarbomonocyclic article diol reaction products production. with cycloalkylcarbomonocycle and polysubstituted heteromonocycle. P-24-0009.............. 1 10/19/2023 Chevron Phillips (S) Heat transfer (S) Eicosane, branched and Chemical agent for linear. Company, LP. direct, immersive liquid cooling of electronic components; (S) Synthetic base oil for use in lubricants; (S) Lubricity additive for drilling fluids. P-24-0011.............. 1 10/24/2023 High Plains (S) Used as a (S) Alkanes, C5-11- Bioenergy, LLC. component of branched and linear. fuels (e.g., gasoline, E85) to increase the vapor pressure; (S) Chemical intermediate use (e.g., petrochemical feedstock). P-24-0013.............. 1 10/26/2023 Momentive (S) Resin/binder (G) Siloxanes and Performance in paint Silicones, di-Me, hydroxy- Materials. formulations for terminated, polymers with industrial 3-[[3-alkoxy-1- coatings. (alkoxycarbonyl)-3- oxoalkyl]heteroatom]propy l Me silsesquioxanes, alkoxy-terminated. [[Page 80297]] SN-21-0006A............ 3 10/30/2023 Carbice.......... (S) For heat (S) Multiwalled carbon transfer, heat nanotubes grown storage, thermal perpendicularly on an emission, and aluminum foil substrate general using Fe catalyst. temperature management in heat-generating systems such as electronics; (S) To improve mechanical properties or electrical conduciveness of other materials or products; (S) For light absorption properties; (S) Gap filling or sealing of opposing interfaces. ---------------------------------------------------------------------------------------------------------------- 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 10/01/2023 to 10/31/2023 ---------------------------------------------------------------------------------------------------------------- Commencement If amendment, type of Case No. Received date date amendment Chemical substance ---------------------------------------------------------------------------------------------------------------- P-13-0355..................... 10/10/2023 08/31/2023 N (S) Phenol, 2,6- dimethyl-, homopolymer, ether with 2,2'', 3,3'', 5,5''-hexamethyl [1,1'-biphenol]-4, 4''-diol (2:1). P-22-0057..................... 10/30/2023 10/13/2023 N (G) Polysaccharide, polymer with 2- propenoic acid, sodium salt. ---------------------------------------------------------------------------------------------------------------- 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 10/01/2023 to 10/31/2023. ---------------------------------------------------------------------------------------------------------------- Type of test Case No. Received date information Chemical substance ---------------------------------------------------------------------------------------------------------------- P[dash]14[dash]0712................. 10/12/2023 Polychlorinated (S) Waste plastics, Dibenzodioxins and pyrolyzed, C5-55 fraction Polychlorinated dibenzofurans Testing. P[dash]18[dash]0304................. 10/04/2023 PAG 2A Direct (G) Sulfonium, Photolysis Study bis(dihalocarbomonocycle) Report,. carbomonocycle, salt with PAG 3A Direct substituted Photolysis Study heteropolycycle dihalo Report,. sulfoalkanoate (1:1). PAG 5 Direct Photolysis Study Report. P[dash]19[dash]0079, 10/06/2023 PAG 2A Direct (G) Substituted P[dash]19[dash]0111, Photolysis Study heterocyclic onium P[dash]19[dash]0112, Report,. compound, salt with 2,2,2- P[dash]19[dash]0114, PAG 3A Direct trifluoro-1-(sulfomethyl)- P[dash]19[dash]0133. Photolysis Study 1-(trifluoromethyl)ethyl 3- Report,. [(2-methyl-1-oxo-2-propen- PAG 5 Direct Photolysis 1- Study Report. yl)oxy]tricyclo[3.3.1.13,7 ]decane-1- carboxylate (1:1), polymer with acenaphthylene, 1-ethenyl- 4-[[1-(1- methylethyl)cyclopentyl]ox y]benzene and 4- ethenylphenol, di-me 2,2'- (1,2-diazenediyl)bis[2- methylpropanoate]- initiated. [[Page 80298]] P[dash]20[dash]0122, 10/6/2023 PAG 2A Direct (S) 1-(4-tert- P[dash]20[dash]0139, Photolysis Study butylphenyl)tetrahydro[2- P[dash]20[dash]0140, Report,. \14\C]thiophen-1-ium P[dash]20[dash]0141, PAG 3A Direct nonaflate; (S) (4- P[dash]20[dash]0142. Photolysis Study hydroxy[U-\14\C]phenyl)- Report,. diphenyl-sulfonium PAG 5 Direct Photolysis trifluoromethanesulfonate; Study Report. (S) tris(4-tert-butyl[mono- U-\14\C]phenyl)sulfonium nonaflate. P[dash]20[dash]0145, 10/6/2023 PAG 2A Direct (S) 1-(4-tert- P[dash]20[dash]0147, Photolysis Study butylphenyl)tetrahydro[2- P[dash]20[dash]0152, Report,. \14\C]thiophen-1-ium P[dash]20[dash]0155, PAG 3A Direct nonaflate; (S) (4- P[dash]20[dash]0159. Photolysis Study hydroxy[U-\14\C]phenyl)- Report,. diphenyl-sulfonium PAG 5 Direct Photolysis trifluoromethanesulfonate; Study Report. (S) tris(4-tert-butyl[mono- U-\14\C]phenyl)sulfonium nonaflate. P[dash]17[dash]0178, 10/6/2023 PAG 2A Direct (S) 1-(4-tert- P[dash]18[dash]0013, Photolysis Study butylphenyl)tetrahydro[2- P[dash]18[dash]0014, Report,. \14\C]thiophen-1-ium P[dash]18[dash]0037, PAG 3A Direct nonaflate; (S) (4- P[dash]19[dash]0078. Photolysis Study hydroxy[U-\14\C]phenyl)- Report,. diphenyl-sulfonium PAG 5 Direct Photolysis trifluoromethanesulfonate; Study Report. (S) tris(4-tert-butyl[mono- U-\14\C]phenyl)sulfonium nonaflate. P[dash]22[dash]0129, 10/6/2023 PAG 2A Direct (S) 1-(4-tert- P[dash]23[dash]0050. Photolysis Study butylphenyl)tetrahydro[2- Report,. \14\C]thiophen-1-ium PAG 3A Direct nonaflate; (S) (4- Photolysis Study hydroxy[U-\14\C]phenyl)- Report,. diphenyl-sulfonium PAG 5 Direct Photolysis trifluoromethanesulfonate; Study Report. (S) tris(4-tert-butyl[mono- U-\14\C]phenyl)sulfonium nonaflate. P[dash]19[dash]0079, 10/27/2023 PAG 2 Direct Photolysis (S) tri[mono-U- P[dash]19[dash]0111, Study Report. \14\C]phenylsulfonium 2- P[dash]19[dash]0112, (adamantane-1- P[dash]19[dash]0114, carbonyloxy)-1,1-difluoro- P[dash]19[dash]0133. ethanesulfonate. P[dash]20[dash]0122, 10/27/2023 PAG 2 Direct Photolysis (S) tri[mono-U- P[dash]20[dash]0139, Study Report. \14\C]phenylsulfonium 2- P[dash]20[dash]0140, (adamantane-1- P[dash]20[dash]0141, carbonyloxy)-1,1-difluoro- P[dash]20[dash]0142. ethanesulfonate P[dash]20[dash]0145, 10/27/2023 PAG 2A Direct (S) tri[mono-U- P[dash]20[dash]0147, Photolysis Study \14\C]phenylsulfonium 2- P[dash]20[dash]0152, Report. (adamantane-1- P[dash]20[dash]0155, carbonyloxy)-1,1-difluoro- P[dash]20[dash]0159. ethanesulfonate. P[dash]22[dash]0129, 10/27/2023 PAG 2 Direct Photolysis (S) tri[mono-U- P[dash]23[dash]0050. Study Report. \14\C]phenylsulfonium 2- (adamantane-1- carbonyloxy)-1,1-difluoro- ethanesulfonate P[dash]17[dash]0178, 10/27/2023 PAG 2 Direct Photolysis (S) tri[mono-U- P[dash]18[dash]0013, Study Report. \14\C]phenylsulfonium 2- P[dash]18[dash]0014, (adamantane-1- P[dash]18[dash]0037, carbonyloxy)-1,1-difluoro- P[dash]19[dash]0078. ethanesulfonate. P[dash]11[dash]0557................. 10/31/2023 Annual reporting of (G) 2-Propenoic acid, 2- Certificate of methyl-, 2-hydroxyethyl Analysis test data and ester, telomers with C18- import volumes. 26-alkyl acrylate, 1- dodecanethiol, N- (hydroxymethyl)-2-methyl-2- propenamide, polyfluorooctyl methacrylate and vinylidene chloride, 2,2'- [1 ,2-diazenediylbis(1- methylethylidene)bis[4,5- dihydro-1 H-imidazole] hydrochloride (1 :2)- initiated. ---------------------------------------------------------------------------------------------------------------- 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: November 13, 2023. Pamela Myrick, Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics. [FR Doc. 2023-25437 Filed 11-16-23; 8:45 am] BILLING CODE 6560-50-P