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Environmental Protection Agency (EPA).
Notice.
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 2/1/2023 to 2/28/2023.
Comments identified by the specific case number provided in this document must be received on or before April 19, 2023.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2022-0132, through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically ( printed page 16627) 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 technical information contact: Jim Rahai, Project Management and Operations Division (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.
This document provides the receipt and status reports for the period from 2/01/2023 to 2/28/2023. 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.
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/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.
This action provides information that is directed to the public in general.
No.
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.
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.
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 ( printed page 16628) 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.
| Case No. | Version | Received date | Manufacturer | Use | Chemical substance |
|---|---|---|---|---|---|
| J-23-0004 | 1 | 02/08/2023 | Danisco US, Inc | (G) Production of a chemical substance | (G) Genetically modified microorganism for the production of a chemical substance. |
| P-19-0095A | 8 | 02/07/2023 | CBI | (G) Consumer Disposables, Polymer Sheet, Durable Goods | (G) Poly hydroxy alkanoate. |
| P-21-0086A | 5 | 02/02/2023 | Croda, Inc | (G) Industrial Rolling oil, Compressor oil, hydraulic oil, Industrial turbine oil, Industrial gear oil, Automotive gear oil, Refrigeration oil, Industrial drilling oil, Marine engine oil additive, Automotive engine oil additive, polymer additive, Greases, Metal working fluid | (S) Isooctadecanamide, N,N-bis(2-ethylhexyl). |
| P-21-0086A | 6 | 02/27/2023 | Croda, Inc | (G) Industrial Rolling oil, Compressor oil, hydraulic oil, Industrial turbine oil, Industrial gear oil, Automotive gear oil, Refrigeration oil, Industrial drilling oil, Marine engine oil additive, Automotive engine oil additive, polymer additive, Greases, Metal working fluid | (S) Isooctadecanamide, N,N-bis(2-ethylhexyl). |
| P-22-0054A | 3 | 02/01/2023 | CBI | (G) Additive for paint and coatings | (G) Graphene nanoplatelets. |
| P-22-0071A | 4 | 02/24/2023 | Lamberti USA, Inc | (G) Industrial Surfactant | (S) D-Glucopyranose, oligomeric, maleates, C9-11-alkyl glycosides, sulfonated, potassium salts. |
| P-22-0072A | 4 | 02/24/2023 | Lamberti USA, Inc | (G) Industrial Surfactant | (S) D-Glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts. |
| P-22-0073A | 4 | 02/24/2023 | Lamberti USA, Inc | (G) Industrial Surfactant | (S) D-Glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium salts. |
| P-22-0095A | 3 | 02/03/2023 | Locus Fermentation Solutions | (G) Surfactant for consumer, industrial, and commercial applications | (G) Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates. |
| P-22-0096A | 3 | 02/03/2023 | Locus Fermentation Solutions | (G) Surfactant for consumer, industrial, and commercial applications | (G) Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates. |
| P-22-0097A | 3 | 02/03/2023 | Locus Fermentation Solutions | (G) Surfactant for consumer, industrial, and commercial applications | (G) Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates. |
| P-22-0098A | 3 | 02/03/2023 | Locus Fermentation Solutions | (G) Surfactant for consumer, industrial, and commercial applications | (G) Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates. |
| P-22-0099A | 3 | 02/03/2023 | Locus Fermentation Solutions | (G) Surfactant for consumer, industrial, and commercial applications | (G) Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates. |
| P-22-0100A | 3 | 02/03/2023 | Locus Fermentation Solutions | (G) Surfactant for consumer, industrial, and commercial applications | (G) Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates. |
| P-22-0119A | 4 | 02/15/2023 | CBI | (G) Resin for packaging, Binding agent | (G) Polyhydroxyalkanoate. |
| P-22-0120A | 4 | 02/15/2023 | CBI | (G) Resin for packaging materials, Binder | (G) Polyhydroxyalkanoate. |
| P-22-0151A | 2 | 02/01/2023 | CBI | (G) Surfactant for commercial applications | (G) Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates. |
| P-22-0151A | 3 | 02/03/2023 | CBI | (G) Surfactant for commercial applications | (G) Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates. |
| P-22-0151A | 4 | 02/15/2023 | CBI | (G) Surfactant for commercial applications | (G) Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates. |
| ( printed page 16629) | |||||
| P-23-0063 | 1 | 01/08/2023 | CBI | (G) Dyestuff | (G) 3-Heteromonocycle methanesulfonic acid, 5-[2-[5-[[4-chloro-6-[[3(or 4)-sulfo-carbomonocyclic]amino]heteromonocyclic]amino]-2-sulfocarbomonocyclic]diazenyl]-1-ethyl-6-hydroxy-4-methyl-2-oxo-, sodium salt (1:3). |
| P-23-0066A | 2 | 02/06/2023 | CBI | (G) An antioxidant additive | (G) alkylated phenyl-naphthalene amine. |
| P-23-0067 | 2 | 02/01/2023 | CBI | (G) cleaner | (G) Ethoxylated Fatty Acid Amide. |
| P-23-0067A | 3 | 02/23/2023 | CBI | (G) Cleaner | (G) Ethoxylated Fatty Acid Amide. |
| P-23-0068A | 5 | 02/21/2023 | US Polymers Accurez, LLC | (S) Ingredient in industrial primers and topcoats | (S) 1,3-Isobenzofurandione, hexahydro-, polymer with 1,4-cyclohexanedimethanol, isononanoate. |
| P-23-0069 | 2 | 02/07/2023 | CBI | (S) Encapsulating Shell Polymer for Fragrance Encapsulates for Industrial or Household Consumer Products such as Detergents and Fabric Softeners | (G) Pea extract, glycerol, carboxymethyl cellulose sodium salt, sodium hyaluronate, maltodextrin and tannins crosslinked polymer with linear and cyclic aliphatic isocyanates. |
| P-23-0072 | 2 | 01/31/2023 | Allnex USA, Inc | (S) UV resin for offset lithographic printing on plastic substrates | (G) Halosubstituted carbopolycycle, polymer with substituted carbomonocycles and oxybis[alkanol]. |
| P-23-0077 | 2 | 02/06/2023 | CBI | (G) Additive for industrial applications | (G) Alkanepolyoxy acid, alkyl substituted. |
| P-23-0078 | 3 | 02/15/2023 | Huntsman International, LLC | (S) Polyester polyol which will be used in combination with other ingredients to make the B side of a spray polyurethane foam formulation. The A side (isocyanate) and B side are reacted together to produce a polyurethane foam that is used as insulation in buildings | (G) soybean oil polymer with alkylene glycol- and glycerol- and alkylene glycol- and alkylene glycol-depolymd. poly(alkylene terephthalate), hydroxy-(hydroxyalkyl)-alkylalkanoic acid phthalic anhydride. |
| P-23-0080 | 1 | 02/06/2023 | CBI | (G) Photoacid generator (PAG) for use in semiconductor industry | (G) Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt. |
| P-23-0081 | 2 | 02/15/2023 | Ashland, Inc | (S) Polymer used as non-ionic surfactant in wood coating formulations | (G) Alkyl glycidyl ether, polymer with Poly(oxy-1,2-ethanediyl). |
| P-23-0083 | 1 | 02/08/2023 | CBI | (G) Photolithography | (G) Sulfonium, tricarbocyclic-, [polyhydro-alkyl-(polyfluoro-2-heteroatom substituted)-alkano-heteromonocyclic] alkyl ester (1:1). |
| P-23-0084 | 1 | 02/09/2023 | Colonial Chemical, Inc | (S) Lubricant additive, water based cutting fluids, institutional cleaning products, and cleaning in place applications, Surfactant used in personal care products such as body cleansers, shower gels, shampoos, etc. Aids foam boosting, foam stabilization, viscosity control, skin emolliency, wetting, detergency, emulsification, and solubilization in solid actives | (G) amides, vegetable oil, hydroxylated amine. |
| P-23-0084A | 2 | 02/16/2023 | Colonial Chemical, Inc | (S) Lubricant additive, water based cutting fluids, institutional cleaning products, and cleaning in place applications, Surfactant used in personal care products such as body cleansers, shower gels, shampoos, etc. Aids foam boosting, foam stabilization, viscosity control, skin emolliency, wetting, detergency, emulsification, and solubilization in solid actives | (G) amides, vegetable oil, hydroxylated amine. |
| P-23-0085 | 1 | 02/09/2023 | Colonial Chemical, Inc | (S) Lubricant additive, water based cutting fluids, institutional cleaning products, and cleaning in place applications (G) Personal care surfactant | (G) amides, soya, hydroxylated amine. |
| P-23-0085A | 2 | 02/16/2023 | Colonial Chemical, Inc | (S) Lubricant additive, water based cutting fluids, institutional cleaning products, and cleaning in place applications, Surfactant used in personal care products such as body cleansers, shower gels, shampoos, etc. Aids foam boosting, foam stabilization, viscosity control, skin emolliency, wetting, detergency, emulsification, and solubilization in solid actives. (G) Personal care surfactant | (G) amides, soya, hydroxylated amine. |
| ( printed page 16630) | |||||
| P-23-0087 | 1 | 02/10/2023 | Evonik Corporation | (S) Adhesives and Sealants for various applications | (S) Oxirane, 2-methyl-, polymer with 2-[[3-(triethoxysilyl)propoxy]methyl]oxirane, monoether with -butyl—hydroxypoly[oxy(methyl-1,2-ethanediyl)]. |
| P-23-0093 | 2 | 02/23/2023 | CBI | (G) Photoacid generator (PAG) for use in semiconductor industry | (G) Aromatic Dibenzothiophenium fluoroalkyl carbopolycycle sulfonic acid salt. |
| P-23-0094 | 1 | 02/24/2023 | Sika Corporation | (S) Reactive polymer for use in surface pre-treatment. | (G) Polymer of benzenedicarboxylic acid, substituted-benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and triisocyanate. |
| SN-22-0006A | 3 | 02/13/2023 | MacDermid Enthone, Inc | (G) Catalyst (contained use) | (S) Tungstate (W12(OH)2O386-), sodium (1:6). |
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.
| Case No. | Received date | Commencement date | If amendment, type of amendment | Chemical substance |
|---|---|---|---|---|
| P-13-0471 | 02/01/2023 | 01/24/2023 | N | (G) Methylene diisocyanate polymer with polypropylene glycol and diols (generic). |
| P-14-0069 | 02/07/2023 | 01/13/2023 | N | (G) Polymer of substituted-naphthalene, substituted-benzenecarboxylic acid, benzenediol and substituted-naphthalene. |
| P-16-0495 | 02/02/2023 | 02/02/2023 | N | (G) 2-pentanol, 4-methyl-, reaction products with phosphorus oxide (p2o5), compounds with alkylamine. |
| P-19-0076 | 02/02/2023 | 01/10/2023 | N | (G) Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with dihalo substituted alkyl carbopolycyclic carboxylate (1:1). |
| P-19-0188 | 02/13/2023 | 02/01/2023 | N | (G) Octadecenamide, n,n-alkyl, modified. |
| P-21-0077 | 02/21/2023 | 12/10/2022 | N | (G) Alkylene sulfate. |
| P-21-0187A | 02/14/2023 | 09/14/2022 | Amendment requested by EPA regarding CBI request reasoning | (G) Glycerine, alkoxylated alkyl acid esters. |
| P-21-0199 | 02/28/2023 | 01/30/2023 | N | (G) 1,6-disubstituted hexane (see cover letter). |
| P-21-0202 | 02/02/2023 | 01/10/2023 | N | (G) Sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], substituted carbomonocyclic ester. |
| P-22-0009 | 02/15/2023 | 02/12/2023 | N | (S) Alkanes, c4-c9-branched and linear. |
| P-22-0017 | 02/13/2023 | 02/07/2023 | N | (S) 1-eicosanol, manuf. of, distn., residues. |
| * 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. | ||||
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: March 14, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.
[FR Doc. 2023-05598 Filed 3-17-23; 8:45 am]
BILLING CODE 6560-50-P
2 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.