2024-03533. Certain New Chemicals; Receipt and Status Information for January 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 1/01/2024 to 1/31/2024.

DATES:

Comments identified by the specific case number provided in this document must be received on or before March 25, 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: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

This document provides the receipt and status reports for the period from 1/01/2024 to 1/31/2024. 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.

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 1/01/2024 to 1/31/2024

Case No.	Version	Received date	Manufacturer	Use	Chemical substance
J–24–0001	2	01/19/2024	CBI	(G) Chemical production	(G) Chromosomally modified Saccharomyces cerevisiae.
J–24–0002	2	01/19/2024	CBI	(G) Chemical production	(G) Chromosomally modified Saccharomyces cerevisiae.
P–20–0031A	8	01/22/2024	CBI	(G) Intermediate	(G) Perfluorinated substituted 1,3-oxathiolane dioxide.
P–20–0033A	6	01/22/2024	CBI	(G) Intermediate	(G) Perfluorinated vinyl haloalkane sulfonate salt.
P–20–0034A	6	01/22/2024	CBI	(G) Intermediate	(G) Perfluorinated vinyl haloalkane sulfonyl halide.
P–22–0002A	6	01/05/2024	Materion Advanced Chemicals	(G) This product is used for the manufacturing of electronic devices	(G) Metal Oxide Chloride.
P–22–0169A	4	01/24/2024	Solugen, Inc	(G) Additive for consumer, commercial, and industrial applications	(G) Polycarboxylic acid, salt.
P–22–0170A	4	01/24/2024	Solugen, Inc	(G) Additive for consumer, commercial, and industrial applications	(G) Polycarboxylic acid, salt.
P–22–0171A	4	01/24/2024	Solugen, Inc	(G) Additive for consumer, commercial, and industrial applications	(G) Polycarboxylic acid, salt.
P–22–0172A	4	01/24/2024	Solugen, Inc	(G) Additive for consumer, commercial, and industrial applications	(G) Polycarboxylic acid, salt.
P–22–0173A	4	01/24/2024	Solugen, Inc	(G) Additive for consumer, commercial, and industrial applications	(G) Polycarboxylic acid, salt.
P–22–0174A	4	01/24/2024	Solugen, Inc	(G) Additive for consumer, commercial, and industrial applications	(G) Polycarboxylic acid, salt.
P–23–0001A	2	01/23/2024	Solugen, Inc	(G) Additive for industrial, and commercial applications	(G) Polycarboxylic acid, salt.
P–23–0002A	2	01/23/2024	Solugen, Inc	(G) Additive for industrial, and commercial applications	(G) Polycarboxylic acid, salt.
P–23–0003A	2	01/23/2024	Solugen, Inc	(G) Additive for industrial, and commercial applications	(G) Polycarboxylic acid, salt.
P–23–0004A	2	01/23/2024	Solugen, Inc	(G) Additive for industrial, and commercial applications	(G) Polycarboxylic acid, salt.
P–23–0005A	2	01/23/2024	Solugen, Inc	(G) Additive for industrial, and commercial applications	(G) Polycarboxylic acid, salt.
P–23–0022A	3	01/08/2024	Cabot Corporation	(G) Additive used in industrial applications	(G) Multi-walled carbon nanotubes.
P–23–0023A	3	01/08/2024	Cabot Corporation	(G) Additive used in industrial applications	(G) Multi-walled carbon nanotubes.
P–23–0024A	3	01/08/2024	Cabot Corporation	(G) Additive used in industrial applications	(G) Multi-walled carbon nanotubes.
P–23–0025A	2	01/23/2024	Solugen, Inc	(G) Additive for industrial, consumer, and commercial applications	(G) Polycarboxylic acid, salt.
P–23–0026A	2	01/23/2024	Solugen, Inc	(G) Additive for industrial, consumer, and commercial applications	(G) Polycarboxylic acid, salt.
P–23–0027A	2	01/23/2024	Solugen, Inc	(G) Additive for industrial, consumer, and commercial applications	(G) Polycarboxylic acid, salt.
P–23–0033A	3	01/08/2024	Cabot Corporation	(G) Additive used in industrial applications	(G) Multi-walled carbon nanotubes.
P–23–0117A	4	12/29/2023	Braven Environmental, LLC	(S) Feedstock blended into fuels and fuel blendstocks (S) Chemical feedstock	(G) Waste plastics, pyrolyzed, condensate.
P–23–0117A	5	01/03/2024	Braven Environmental, LLC	(S) Feedstock blended into fuels and fuel blendstocks (S) Chemical feedstock	(G) Waste plastics, pyrolyzed, condensate.
P–23–0149	3	01/16/2024	CBI	(S) This material is a catalyst	(G) Dialkyltin Fatty acids ester.
P–24–0001A	2	01/10/2024	Cabot Corporation	(G) Additive used in industrial applications	(G) Carbon Nanostructures, purified.
P–24–0002	4	01/18/2024	CBI	(G) Photocurable coatings and inks	(G) Poly[oxy(methyl-1,2-ethanediyl)], alpha-hydro-omega-hydroxy-, ether with polyol (4:1), 2-propenoate.
P–24–0003	3	01/09/2024	CBI	(G) Photocurable coatings and inks	(G) Poly[oxy(methyl-1,2-ethanediyl)], alpha-hydro-omega-hydroxy-, ether with polyol (4:1), mono[2-[(9-oxo-9H-thioxanthen-2-yl)oxy]acetate] 2-propenoate.
P–24–0018	2	11/22/2023	CBI	(G) Additives for lubricating oil	(G) Copolymer of alkyl methacrylate, alkyl(C=32) methacrylate, alkyl(C=28) methacrylate and oxygen-substituted alkyl methacrylate.
P–24–0043A	2	01/22/2024	Clariant Corporation	(S) Catalyst for use in petrochemical operations	(S) Iron potassium oxide (FeKO2).
P–24–0046	1	01/03/2024	The Euclid Chemical Company	(S) Grinding aid used in cement manufacture	(G) Alkanol, alkoxyalkylimino, salt.
P–24–0047	1	01/03/2024	The Euclid Chemical Company	(S) Grinding aid used in cement manufacture	(G) Alkanol, nitrilo, salt.
P–24–0048	1	01/05/2024	CBI	(G) Ingredient for consumer products	(G) Ethyl Octenenitrile.
P–24–0067	1	01/11/2024	Swan Chemical, Inc	(S) Rubber accelerator	(S) Methanethioic acid, 1,1′-tetrathiobis-, O1,O1′-bis(1-methylethyl) ester.
P–24–0069	1	01/17/2024	Soulbrain Mi	(S) Additive for use in battery electrolyte formulations	(G) Oxa-thiaspiro alkane, oxide.
P–24–0075	1	01/23/2024	Allnex USA, Inc	(S) CYMEL NF 2264/87WA RESIN will be used as a water-based formaldehyde free crosslinking additive for acid resistance	(G) Carbamic acid, N, N′, N″-1,3,5-triazine-2,4,6-tryltris-, mixed alkyl triesters.
SN–22–0007A	7	12/29/2023	Braven Environmental, LLC	(G) Product of Pyrolysis Manufacturing	(S) Waste plastics, pyrolyzed, C5–12 fraction.
SN–22–0008A	7	12/29/2023	Braven Environmental, LLC	(G) Product of Pyrolysis Manufacturing	(S) Waste plastics, pyrolyzed, C20–55 fraction.
SN–22–0008A	8	01/25/2024	Braven Environmental, LLC	(G) Product of Pyrolysis Manufacturing	(S) Waste plastics, pyrolyzed, C20–55 fraction.
SN–22–0009A	7	12/29/2023	Braven Environmental, LLC	(G) Product of Pyrolysis Manufacturing	(S) Waste plastics, pyrolyzed, C9–20 fraction.
SN–24–0002A	2	01/29/2024	CBI	(G) A component used in battery manufacture	(G) Carbon.
SN–24–0003	3	01/17/2024	Diamond Green Diesel, LLC	(S) Transportation Fuel, Feedstock for monomer production for polymer manufacturing, Product will be a renewable blend component of consumer transportation fuels	(S) Alkanes, C4–8–branched and linear.
SN–24–0004	1	01/11/2024	Olin Corporation	(G) Reactive diluent in coatings	(S) Oxirane, 2,2′-[1,6-hexanediylbis(oxymethylene)]bis-.

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 1/01/2024 to 1/31/2024

Case No.	Received date	Commencement date	If amendment, type of amendment	Chemical substance
P–17–0295A	01/30/2024	03/31/2023	Amended chemical name	(S) 1-propene, 1-chloro-2,3,3,3-tetrafluoro-, (z)-.
P–19–0111	01/29/2024	01/28/2024	N	(G) Dibenzothiophenium, trifluoro-hydroxy-(triheterosubstitutedalkyl)alkaoate (1:1).
P–19–0180	01/23/2024	06/16/2023	N	(S) Benzoic acid, 2-chloro-5-fluoro-, sodium salt (1:1).
P–20–0139	01/30/2024	01/28/2024	N	(G) Sulfonium, triphenyl-, 1,2-fluoroalkyltricycloalkyl-1-carboxylate (1:1).
P–20–0142	01/30/2024	01/28/2024	N	(G) Dibenzothiophenium, 5-phenyl-, salt with 2,2-difluoro-2-sulfoethyl substituted-heterotricycloalkane-carboxylate (1:1).
P–20–0145	01/30/2024	01/28/2024	N	(G) Substituted heterocyclic onium compound, salt with fluoropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1), polymer with disubstitutedaromatic compound and 1-methylcyclopentyl 2-methyl-2-propenoate, di-me 2,2′-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated.
P–20–0152	01/30/2024	01/28/2024	N	(G) Sulfonium, triphenyl-, salt with 2,2-difluoro-2-sulfoethyl-2-oxo substituted -heterotricycloalkane-heteropolycyclo-carboxylate (1:1).
P–21–0073A	01/03/2024	09/07/2023	Amended chemical name	(S) 1,4-cyclohexanedicarboxylic acid, 1,4-dinonyl ester, branched and linear.
P–22–0038	01/02/2024	12/21/2023	N	(G) Siloxanes and silicones, di-me, mixed (polyhydro-substituted heterocyclic) alkyl group and [(polyalkylsilyl)substituted]-terminated.
P–23–0028	01/09/2024	01/09/2024	N	(G) Gelatin and maltodextrin crosslinked with linear and cyclic aliphatic polyisocyanates.

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 1/01/2024 to 1/31/2024

Case No.	Received date	Type of test information	Chemical substance
L–24–0109	01/05/2024	Melting Point/Melting Range (OECD Test Guideline 102); Boiling Point/Boiling Range (OECD Test Guideline 103)	(G) Amide, bis(carboheterocyclic)alkyl, polymer with alkylsubstituted polyalkylene glycol.
L–24–0111	01/10/2024	Skin Sensitization (OECD Test Guideline 406); Bacterial Reverse Mutation Test (OECD Test Guideline 471); Determination of the Number-Average Molecular Weight and the Molecular Weight Distribution of Polymers using Gel Permeation Chromatography (OECD Test Guideline 118); Determination of the Low Molecular Weight Content of a Polymer using Gel Permeation Chromatography (OECD Test Guideline119); Storage Stability (OECD Test Guideline 113); Density/Relative Density/Bulk Density (OECD Test Guideline 109)	(G) Amide, bis (carboheterocyclic)alkyl), polymer with polyether dialkanesulfonate, reaction products with heteromonocyclic alkyl carbomonocyclic amide.
P–09–0644	1/2/2024	Annual reporting pursuant to modified consent order	(G) Substituted alkyl phosphate ester.
P–09–0645	1/2/2024	Annual reporting pursuant to modified consent order	(G) Substituted alkyl phosphate ester, ammonium salt.
P–10–0317	1/04/2024	Impurity measurements	(G) Fluoroalkyl acrylate copolymer.
P–13–0679	1/04/2024	Impurity measurements	(G) Fluoroalkyl acrylate copolymer.
P–14–0053	01/26/2024	Ready Biodegradability (OECD Test Guideline 301)	(S) 2-pentanone, 3-methyl-5-(2,2,3-trimethylcyclopentyl)-.
P–14–0712	01/08/2024	Polychlorinated Dibenzodioxins and Polychlorinated dibenzofurans Testing	(S) Waste plastics, pyrolyzed, C5–55 fraction.
P–14–0712	01/09/2024	Polychlorinated Dibenzodioxins and Polychlorinated dibenzofurans Testing	(S) Waste plastics, pyrolyzed, C5–55 fraction.
P–21–0056	01/25/2024	In Chemico Skin Sensitization (OECD Test Guideline 442C); In Vitro Skin Sensitation (OECD Test Guideline 442E); Antioxidant-Response-Element Dependent Gene Activity and Cytotoxicity	(G) Isocyanic acid, polyalkylenepolyarylene ester, polymer with alkyl-hydroxyalkyl-alkanediol, alkoxyalcohol and alkoxylalkoxyalcohol-blocked.
P–23–0136	01/02/2024	Acute Oral Toxicity (AOT)2 (OECD Test Guideline 425); In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (OECD Test Guideline 439); Melting Point/Melting Range (OECD Test Guideline 102); Boiling Point/Boiling Range (OECD Test Guideline 103); Density/Relative Density/Bulk Density (OECD Test Guideline 109); Partition Coefficient (n-octanol/water), Estimation by Liquid Chromatography (OECD Test Guideline 117); Water Solubility: Column Elution Method; Shake Flask Method (OECD Test Guideline 105); Vapor Pressure (OECD Test Guideline 104); Bacterial Reverse Mutation Test (OECD Test Guideline 471)	(G) Fatty acids, reaction products with hexamethylenediamine and 12-hydroxyoctadecanoic acid.

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: February 15, 2024.

Pamela Myrick,

Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.