[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)] [Notices] [Pages 84578-84583] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2024-24503] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2024-0057; FRL-11683-09-OCSPP] Certain New Chemicals; Receipt and Status Information for September 2024 AGENCY: Environmental Protection Agency (EPA). [[Page 84579]] 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 9/1/ 2024 to 9/30/2024. DATES: Comments identified by the specific case number provided in this document must be received on or before November 22, 2024. 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. SUPPLEMENTARY INFORMATION: I. Executive Summary A. What action is the Agency taking? This document provides the receipt and status reports for the period from 9/1/2024 to 9/30/2024. 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. [[Page 84580]] 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 9/1/2024 to 9/30/2024 ---------------------------------------------------------------------------------------------------------------- Received Case No. Version date Manufacturer Use Chemical substance ---------------------------------------------------------------------------------------------------------------- P-20-0174A.......... 7 08/29/2024 P2 Science, Inc.... (S) For use in (S) 6-Octen-1-ol, 3,7- consumer products, dimethyl-, homopolymer, as well as direct monoacetate. addition to consumer products. Specific functions would be as solubilizer, rheology modifier and fragrance oil. The candidate substance is expected to be used as an ingredient in the formulation of a broad range of consumer products including but not limited to laundry detergents, cleaners, fabric softeners, air fresheners, etc. In addition, it is anticipated to be added as an ingredient to fragrances by fragrance manufacturers, who will then supply these fragrances to downstream consumer product companies to use in the manufacture of their goods. The anticipated range of use levels is 0.1-5.0%. [[Page 84581]] P-20-0184A.......... 5 08/29/2024 P2 Science, Inc.... (S) For use in (S) 6-Octen-1-ol, 3,7- fragrances for dimethyl-, homopolymer. consumer products, as well as direct addition to consumer products. Specific functions would be as solubilizer, rheology modifier and fragrance oil The candidate substance is expected to be used as an ingredient in the formulation of a broad range of consumer products including but not limited to laundry detergents, cleaners, fabric softeners, air fresheners, etc. In addition, it is anticipated to be added as an ingredient to fragrances by fragrance manufacturers, who will then supply these fragrances to downstream consumer product companies to use in the manufacture of their goods. The anticipated range of typical use levels is 0.1- 5.0%. P-22-0158A.......... 4 09/06/2024 Aqdot.............. (G) Additive used (S) 1H,4H,14H,17H- in consumer, 2,16:3,15-Dimethano- commercial, and 5H,6H,7H,8H,9H,10H,11H,1 industrial 2H,13H,18H,19H,20H,21H,2 applications. 2H,23H,24H,25H,26H-2,3,4 a,5a,6a,7a,8a,9a,10a,11a ,12a,13a,15,16,17a,18a,1 9a,20a,21a,22a,23a,24a,2 5a,26a- *tetracosaazabispentalen o[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- 1,4,6,8,10,12,14,17,19,2 1,23,25-dodecone, dodecahydro-, stereoisomer;2,18:3,17- Dimethano- 2,3,4a,5a,6a,7a,8a,9a,10 a,11a,12a,13a,14a,15a,17 ,18,19a,20a,21a,22a,23a, 24a,25a,26a,27a,28a,29a, 30aoctacosaazabispentale no[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- 1,4,6,8,10,12,14,16,19,2 1,23,25,27,29- tetradecone, tetradecahydro-, stereoisomer;2,20:3,19- Dimethano- 2,3,4a,5a,6a,7a,8a,9a,10 a,11a,12a,13a,14a,15a,16 a,17a,19,20,21a,22a,23a, 24a,25a,26a,27a,28a,29a, 30a,31a,32a,33a,34adotri acontaazabispentaleno[1' '''',6''''':5'''',6'''', 7'''']cycloocta[1'''',2' ''',3'''':3''',4''']pent aleno[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- 1,4,6,8,10,12,14,16,18,2 1,23,25,27,29,31,33- hexadecone, hexadecahydro-, stereoisomer. P-23-0117A.......... 6 09/04/2024 Braven (S) Feedstock (G) Waste plastics, Environmental, LLC. blended into fuels pyrolyzed, condensate. and fuel blendstocks; Chemical feedstock. P-23-0138A.......... 2 08/27/2024 CBI................ (S) Photoinitiator: (S) Benzoic acid, 2- Amine Synergists ([1,1'-biphenyl]-4- or Amine Acrylates ylcarbonyl)-, 2- like OPV and ethylhexyl ester. industrial coatings (pigmented systems like offset, flexo and inkjets) No domestic production as this product is for import only. P-23-0149A.......... 4 09/20/2024 CBI................ (S) This material (G) Dialkyltin Fatty is a catalyst. acids ester. P-23-0189A.......... 2 09/06/2024 CBI................ (G) Component in (G) polymers. Dimethanocarbopolycycle, alkyl-polyhydro-. P-23-0189A.......... 3 09/10/2024 CBI................ (G) Component in (G) polymers. Dimethanocarbopolycycle, alkyl-polyhydro-. P-24-0086A.......... 2 09/24/2024 HydroGraph......... (S) Thermosets a. (S) few layer, non- Automotive parts: functionalized, Used to turbostratic graphene in manufacture a powdered form of various automotive aggregated nano- components, such platelets from carbon- as brake pads, rich gas explosion engine mounts, synthesis. electrical connectors, and interior trim, due to their excellent heat resistance and mechanical properties. [[Page 84582]] P-24-0087A.......... 2 09/24/2024 HydroGraph......... (S) Alternative (S) few layer, non- energy: Wind functionalized, blades and solar turbostratic graphene in panels, a powdered form of Construction aggregated nano- materials platelets from carbon- including rich gas explosion concrete, asphalt, synthesis. and other engineered materials. P-24-0104A.......... 6 09/12/2024 CBI................ (G) Plastic (G) carbomonocycle additive. alkylamide, 3,5-bis(1,1- dialkyl)-N-[2,5-dioxo-3- (polyalkylene)-1- heteromonocyclic]- -4- hydroxy-. P-24-0158A.......... 3 09/03/2024 CBI................ (G) Resin for (G) Polyhydroxyalkanoate. packaging, battery technology. P-24-0186A.......... 3 09/04/2024 SGP Ventures, Inc.. (S) Epoxy used to (S) 2-Oxiranemethanamine, fill holes in N-[2-methyl-4-(2- printed circuit oxiranylmethoxy)phenyl]- boards. N-(2-oxiranylmethyl)-. P-24-0192A.......... 4 09/23/2024 Bruhl Chemical (S) Paints, (S) 4- Trade, Inc. coatings and inks. Hydroxybenzophenone, ethoxylated, esters with acrylic acid. P-24-0192A.......... 5 09/26/2024 Bruhl Chemical (S) Paints, (S) poly(oxy-1,2- Trade, Inc. coatings and inks. ethanediyl), alpha-(1- oxo2-propen-1-yl)-omega- (4-benzoylphenoxy)-. P-24-0193........... 1 09/13/2024 CBI................ (G) Dispersive Use. (G) Perfluorosulfonic acid polymer, with perfluorodioxolane. P-24-0195........... 1 09/26/2024 CBI................ (G) Heat transfer (G) Trimers of fluid, Dielectric hexafluoropropene. testing. SN-22-0006A......... 4 08/30/2024 MacDermid Enthone, (G) Catalyst (S) Tungstate Inc. (contained use). (W12(OH)2O386-), sodium (1:6). SN-22-0006A......... 5 09/16/2024 MacDermid Enthone, (G) Catalyst (S) Tungstate Inc. (contained use). (W12(OH)2O386-), sodium (1:6). SN-22-0007A......... 8 09/04/2024 Braven (G) Product of (S) Waste plastics, Environmental, LLC. Pyrolysis pyrolyzed, C5-12 manufacturing. fraction. SN-22-0008A......... 9 09/04/2024 Braven (G) Product of (S) Waste plastics, Environmental, LLC. Pyrolysis pyrolyzed, C20-55 Manufacturing. fraction. SN-22-0009A......... 8 09/04/2024 Braven (G) Product of (S) Waste plastics, Environmental, LLC. Pyrolysis pyrolyzed, C9-20 Manufacturing. fraction. ---------------------------------------------------------------------------------------------------------------- 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 9/1/2024 to 9/30/2024 ---------------------------------------------------------------------------------------------------------------- Received Commencement If amendment, type Case No. date date of amendment Chemical substance ---------------------------------------------------------------------------------------------------------------- P-18-0014A....................... 09/09/2024 04/22/2024 Revised specific (G) Sulfonium, triphenyl- chemical name. , salt with disubstituted- heterocyclic compound (1:1). P-19-0095A....................... 09/12/2024 03/26/2024 Revised generic (G) Alkane, mixed with chemical name. carbon dioxide and oxygen, fermented, hydroxyalkanoic acid homopolymer. P-19-0173........................ 09/05/2024 09/05/2024 N................... (S) Benzoic acid, 2,4- dichloro-5-fluoro-. P-19-0175........................ 09/06/2024 09/06/2024 N................... (S) Benzoic acid, 5- chloro-2-methyl-. P-19-0182........................ 09/05/2024 09/05/2024 N................... (S) Benzoic acid, 2,4- dichloro-5-fluoro-, sodium salt (1:1). P-19-0184........................ 09/06/2024 09/06/2024 N................... (S) Benzoic acid, 5- chloro-2-methyl-, sodium salt (1:1). P-20-0122A....................... 09/09/2024 04/22/2024 Revised generic (G) Heterocyclic onium chemical name. compound with fluorosubstitutedalkyl 2-methyl-2-propenoate (1:1), polymer with acenaphthylene, 4- ethenyl-alpha,alpha- dimethylbenzenemethanol and 4-ethenylphenyl acetate, hydrolyzed. P-21-0002........................ 09/18/2024 12/20/2022 N................... (G) Octadecanoic acid, 12-hydroxy-, polymer with aziridine, 2- oxepanone and tetrahydro-2H-pyran-2- one, reaction products with disubstituted heteropolycycle. P-21-0034........................ 09/26/2024 09/14/2024 N................... (G) Polymer modified multifunctional silane. P-22-0137A....................... 09/17/2024 09/10/2024 N................... (G) Aklyl dialkylamine. P-22-0138........................ 09/17/2024 09/16/2024 N................... (G) Tetraalkylammonium chloride. P-23-0032........................ 09/26/2024 09/12/2024 N................... (S) 1, 3-propanediol, polymer with 1, 3- diisocyanatomethylbenze ne. P-23-0102........................ 09/18/2024 09/01/2024 N................... (G) Glycerides from fermentation of genetically modified microorganism. P-23-0134........................ 09/12/2024 08/14/2024 N................... (S) Poly[oxy(methyl-1,2- ethanediyl)],alpha- hydro-omega-{[2-[(1- chloro-9-oxo-9H- thioxanthen-4- yl)oxy]acetyl]oxy{time} -,ether with 2,2- bis(hydroxymethyl)-1,3- propanediol (4:1). P-23-0142........................ 09/27/2024 09/26/2024 N................... (G) Alkenal, 9- (acetyloxy)-, (E)-. P-23-0160........................ 09/04/2024 08/26/2024 N................... (G) Alkenoyl chloride, 3- methyl-. P-23-0170........................ 09/04/2024 08/19/2024 N................... (G) Ethanaminium, 2-[3- (2,5-dioxo-1- heteromonocyclic) propoxy]-N,N,N- trimethyl-, monopolyisobutylene derivs., Me ethanedioate. P-24-0005........................ 09/12/2024 08/26/2024 N................... (S) [[1,1'-biphenyl]- 4,4'-diol, reaction products with 4- cyclohexylphenol and 2,4,6-trichloro-1,3,5- triazinec. ---------------------------------------------------------------------------------------------------------------- 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 [[Page 84583]] type of test information submitted, and chemical substance identity. Table III--Test Information Received From 9/1/2024 to 9/30/2024 ---------------------------------------------------------------------------------------------------------------- Received Case No. date Type of test information Chemical substance ---------------------------------------------------------------------------------------------------------------- P-14-0712.................... 09/26/2024 Polychlorinated Dibenzodioxins (S) Waste plastics, pyrolyzed, C5- and Polychlorinated 55 fraction. dibenzofurans Testing. P-16-0543.................... 09/24/2024 Exposure Monitoring Report....... (G) Halogenophosphoric acid metal salt. P-21-0180.................... 09/18/2024 Determination of Water Solubility (G) Sulfonium, Report. (halocarbomonocycle)diphenyl-, salt with 1-heterosubstituted-2- methylalkyl trihalobenzoate (1:1). P-22-0086.................... 09/26/2024 Supplementary Test Data Report... (G) Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6- substituted tri- carbopolycycle, hetero-acid)benzenesulfonate (1:1). P-22-0179.................... 09/18/2024 Water Solubility: Column Elution (G) Sulfonium, Method; Shake Flask Method (OECD (alkylsubstitutedphenyl)diphenyl- Test Guideline 105). , salt with 1- (heterosubstitutedalkyl)-2,2,2- triheterosubstitutedalkyl trisubstitutedbenzoate (1:1). P-22-0180.................... 09/18/2024 Water Solubility: Column Elution (G) Dibenzothiophenium, 5-phenyl- Method; Shake Flask Method (OECD , 4-[1-(heterosubstitutedalkyl)- Test Guideline 105). 2,2,2- triheterosubstitutedalkoxy]-4- oxoalkyl trisubstitutedbenzoate (1:1). P-24-0097.................... 09/18/2024 Water Solubility: Column Elution (G) Sulfonium, tris(4- Method; Shake Flask Method (OECD fluorophenyl)-, Test Guideline 105). (substitutedphenoxy)alkyl substitutedbenzoate (1:1). ---------------------------------------------------------------------------------------------------------------- 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: October 17, 2024. Pamela Myrick, Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics. [FR Doc. 2024-24503 Filed 10-22-24; 8:45 am] BILLING CODE 6560-50-P