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 Environmental Protection Agency [EPA-HQ-OPPT-2023-0061; FRL-10581-12-OCSPP]
 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 12/01/2023 to 12/31/2023.
 DATES: Comments identified by the specific case number provided in this document must be received on or before February 20, 2024.
 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/​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 12/01/2023 to 12/31/2023. 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); 
                    ( print page 3398)
                    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, 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 12/01/2023 to 12/31/2023
Case No.
Version
Received date
Manufacturer
Use
Chemical substanceJ-24-0001
1
12/13/2023
CBI
(G) Chemical production
(G) Chromosomally-modified Saccharomyces cerevisiae.J-24-0002
1
12/13/2023
CBI
(G) Chemical production
(G) Chromosomally-modified Saccharomyces cerevisiae.P-16-0404A
7
12/01/2023
CBI
(G) A colorant for dyeing various synthetic fibers and fabrics. Open, non-dispersive use
(G) Alkyl ester, 2-({4-[2-(trisubstituted phenyl)azo]-5-acetamido-2-substitutedphenyl} (substituted alkoxy)amino).P-20-0092A
9
12/01/2023
CBI
(G) Coloration of fabric
(G) Napthalenesulfonic acid, amino-hydroxy-bis [sulfo-[(sulfooxy)ethyl]sulfonyl]phenyl]diazinyl]-,potassium sodium salt.P-22-0002A
5
12/06/2023
Materion Advanced Chemicals
(G) This product is used for the manufacturing of electronic devices
(G) Metal Oxide Chloride.P-22-0011A
6
12/20/2023
CBI
(G) Functionalized rubber in resin side of two component epoxy modified acrylic adhesive
(G) Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-[(1-oxo-2-propen-1-yl)oxylethyl]carbamates].P-22-0113A
6
12/12/2023
Solugen, Inc
(G) Chemical intermediate, Additive
(S) D-Glucaric acid.P-23-0148
1
06/22/2023
CBI
(G) Inert component in Pesticides
(G) Amylopectin, 2-hydroxypropyl ether, modified.( print page 3399)P-23-0172A
3
12/18/2023
CBI
(G) Photolithography
(G) Sulfonium, tricarbocyclic-, alkylcarbomonocyclic-polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with alkylaryl and carbomonocyclic alkyl alkanoate, di-Me 2,2′-(1,2-diazenediyl)bis[2-alkylalkanoate]-initiated.P-24-0006
2
12/19/2023
CBI
(S) Oilfield Production Scale Inhibitor
(G) Polymeric salt of Propenoic acid, Acrylamido-methylpropane sulfonic acid sodium salt, Hydroxyethyl methacrylate, Methyl methacrylate, Propenoic acid, methyl-, phosphinicobis(oxy-ethanediyl) ester, Sodium Metabisulfite.P-24-0016
3
11/29/2023
Huntsman International, LLC
(S) Catalyst in 2-part polyurethane spray foam insulation application
(S) 2-Propanamine, N ,N′-(oxydi-2,1-ethanediyl)bis[N-methyl-.P-24-0034
1
11/27/2023
Barentz North America, LLC
(S) Elcosol DM has widespread use as a non-reactive processing aid (no inclusion into or onto article), the substance is not included in the final article as it evaporates. There is no intended consumer use for this application
(S) 2,5,7,10-Tetraoxaundecane, 4,8-dimethyl-.(S) In cleaning products, Elcosol DM has widespread use as a non-reactive processing aid (no inclusion into or onto article). The substance is not included in the final article it is recycled or recuperated for treatment/appropriate disposal; waters are treated through a biological sewage treatment process (STP). In consumer products the NCS is used as a solvent or cosolvent(S) For use in laboratories, Elcosol DM is not included in the final article: it is recycled or recuperated for treatment/appropriate disposal, waters are treated through a biological sewage treatment process (STP). There is no consumer use of this NCS for this application(S) Elcosol DM is used in consumer cleaning products as a solvent or cosolvent. The use of the substance by consumers is expected to fall under do-it yourself (DIY) cleaning products such as glue removers, paint strippers, hard stain removersP-24-0036
3
12/18/2023
CBI
(G) Intermediate
(G) Poly(oxy-alkylene), alpha-alkenyl-omega-hydroxy-,.P-24-0040
2
12/15/2023
Sudoc, LLC
(G) Additive for commercial applications. Additive for non-spray commercial and consumer applications
(G) Metal, aqua[(alkylnitrocarbocyclepolyheteropolyheterocyclopolyalkane-ketone)-polyoxidato]-, metal.P-24-0042
1
12/15/2023
CBI
(G) An ingredient used in the manufacture of photoresist
(G) Sulfonium, bis(dihalocarbomonocycle)carbomonocycle-, salt with (dihalo-sulfoalkyl) (halo-substituted carbomonocycle) carbopolycycle.P-24-0043
1
12/19/2023
Clariant Corporation
(S) Catalyst for use in petrochemical operations
(S) Iron potassium oxide (FeKO2).P-24-0044
1
12/21/2023
CBI
(G) Component in polyurethane and other thermoset resins
(G) Oxirane, 2-methyl-, polymer with oxirane, ether with N-[4-[[4-[bis(2-hydroxyethyl)amino]phenyl](2-substitutedphenyl)methylene]-2,5-cyclohexadien-1-ylidene]-2-hydroxy-N-(2-hydroxyethyl)ethanaminium inner salt (4:1).P-24-0045
1
12/21/2023
CBI
(G) Coating and Adhesives
(G) Cashew, nutshell liq., polymer with epichlorohydrin and glycol.SN-22-0007A
6
12/29/2023
Braven Environmental, LLC
(G) Product of Pyrolysis manufacturing
(S) Waste plastics, pyrolyzed, C5-12 fraction.SN-22-0008A
6
12/29/2023
Braven Environmental, LLC
(G) Product of Pyrolysis Manufacturing
(S) Waste plastics, pyrolyzed, C20-55 fraction.( print page 3400)SN-22-0009A
6
12/29/2023
Braven Environmental, LLC
(G) Product of Pyrolysis Manufacturing
(S) Waste plastics, pyrolyzed, C9-20 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 12/01/2023 to 12/31/2023
Case No.
Received
                             date
Commencement date
If amendment,
                             type of 
                             amendment
Chemical substanceP-21-0168
12/28/2023
12/04/2023
N
(G) Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino]sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium salts,.P-22-0054
12/19/2023
10/17/2023
N
(G) Graphene nanoplatelets.P-22-0127
12/14/2023
12/01/2023
N
(S) Urea, n,n′-bis[3-[[(4-methylphenyl)sulfonyl]oxy]phenyl]-.
 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 12/01/2023 to 12/31/2023
Case No.
Received
                             date
Type of test information
Chemical substanceP-17-0339
12/19/2023
Simulation Test—Aerobic Sewage Treatment—A: Activated Sludge Units (OECD Test Guideline 303A)
(S) Poly(oxy-1,2-ethanedlyl)-alpha-(2-butyl (1-octyl 14
                            C))-omega-hydroxy alcohol.P-19-0166
12/06/2023
Partition Coefficient (n-octanol/water), Shake Flask Method (OECD Test Guideline 107); Partition Coefficient (n-octanol/water), Estimation by Liquid Chromatography (OECD Test Guideline 117)
(G) Triarylsulfonium alkylestersulfonate,.P-23-0165
12/15/2023
Combined Repeated Dose Toxicity with the Reproduction/Development Toxicity Screening Test (OECD Test Guideline 422)
(G) 2,3,3,3-tetrafluoro-2-[(polyfluoroalken-1-yl)oxy]-propanoic acid homopolymer.P-10-0470
12/19/2023
Analytical Information
(G) Fluoro modified, polyether modified and alkyl modified polymethylsiloxane.P-10-0471
12/19/2023
Analytical Information
(G) Fluoro modified, polyether modified polyacrylate.P-10-0472
12/19/2023
Analytical Information
(G) Fluoro modified, polyether modified polyacrylate.P-20-0042, P-18-0016
12/4/2023
Direct Photolysis Study Report
(G) Sulfonium, trisaryl-, 7,7-dialkyl-2-heteropolycyclic-1-alkanesulfonate (1:1); (G) Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt.P-18-0304, P-18-0316, P-18-0338, P-19-0076, P-19-0115, P-19-0142, P-20-0120, P-21-0027
12/12/2023
PAG 2 Direct Photolysis Study Report
(G) Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with substituted heteropolycycle dihalo sulfoalkanoate (1:1).
                             (G) Heteropolycycle, alkylaromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate.(G) Sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl polycarbocyclic alkane-1-carboxylate (1:1).(G) Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with dihalo substituted alkyl carbopolycyclic carboxylate (1:1).(G) Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, substituted carbomonocyclic ester.(G) Heteropolycycle, aromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (1:1).(G) Carbomonocyclic sulfonium, salt with trihalo-sulfoalkyl hydroxycarbopolycyclic carboxylate.(G) Heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic salt.
 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: January 11, 2024. Pamela Myrick, Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.


[FR Doc. 2024-00891 Filed 1-17-24; 8:45 am] BILLING CODE 6560-50-P