Certain New Chemicals; Receipt and Status Information for January 2023

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Federal RegisterFeb 17, 2023
88 Fed. Reg. 10320 (Feb. 17, 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 1/1/2023 to 1/31/2023.

DATES:

Comments identified by the specific case number provided in this document must be received on or before March 20, 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/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 1/01/2023 to 1/31/2023. 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/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 01/01/2023 to 01/31/2023

Case No. Version Received date Manufacturer Use Chemical substance
J-23-0001 7 12/30/2022 Lesaffre Yeast Corporation (G) Ethanol production (G) Saccharomyces cerevisiae, modified to express glucoamylase activity.
J-23-0003 1 12/08/2022 CBI (G) Production of an enzyme mixture (G) Microorganism expressing enzymes.
J-23-0003A 2 01/20/2023 CBI (G) Production of an enzyme mixture (G) Microorganism expressing enzymes.
J-23-0003A 3 01/30/2023 CBI (G) Production of an enzyme mixture (G) Microorganism expressing enzymes.
P-18-0365A 5 01/09/2023 CBI (G) Superabsorbent polymer, (S) Manufacture for export only (G) Starch, carboxymethyl ether, sodium salt, polymer with polycarboxylic acid.
P-18-0366A 5 01/09/2023 CBI (G) Superabsorbent polymer, (S) Manufacture for export only (G) Starch, carboxymethyl ether, sodium salt, polymer with mixed polycarboxylic acids.
P-19-0095A 7 12/22/2022 CBI (G) Consumer Disposables, Polymer Sheet, Durable Goods (G) Poly hydroxy alkanoate.
P-22-0009A 4 01/25/2023 CBI (S) Gasoline blending component to reduce the average carbon intensity and subsequent CO 2 emissions of fuel (S) Alkanes, C4-C9-branched and linear.
P-22-0054A 2 01/05/2023 CBI (G) Additive for paint and coatings (G) Graphene nanoplatelets.
P-22-0068A 3 01/24/2023 Aditya Birla Chemicals (USA), LLC (S) An epoxy component used in a reaction with other components to produce an epoxy article (S) 2-Propanamine, 1,1′-[(1-methylethylidene)bis(oxy)]bis-.
P-22-0182 6 01/16/2023 Goulston Technologies (G) Textile wear additive (G) Poly(ethylene terephthalate)-co-poly(propyl trimethylol alkanoate).
P-23-0014A 6 01/05/2023 CBI (G) Intermediate in production of fragrance (G) [Polyalkyl-methylenepolyhydro-polycyclic]alkyl acetate.
P-23-0036A 3 01/10/2023 Elantas PDG, Inc (S) MF8044 Resin is an unsaturated polyester resin used in an electrical insulation coating. The coating is used to insulate electrical components in automobiles (S) Castor oil, polymer with dicyclopentadiene, maleic anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.
P-23-0042A 2 01/10/2023 Clariant Corporation (S) Intermediate for use in producing polymers (G) Oxirane, alkyl-, polymer with oxirane, monoethers with polyethylene glycol alkenyl ether.
P-23-0045 3 01/05/2023 Colonial Chemical, Inc (S) Water based metalworking fluids, Metal cleaners, Metal treating fluids (G) Carboxylic acid, compound with 2,2′,2″-nitrilotris[ethanol] (1:1);(G) Carboxylic acid, compound with 2-aminoethanol (1:1).
P-23-0045A 4 01/20/2023 Colonial Chemical, Inc (S) Water based metalworking fluids, Metal cleaners, Metal treating fluids (G) Carboxylic acid, compound with 2,2′,2″-nitrilotris[ethanol] (1:1);(G) Carboxylic acid, compound with 2-aminoethanol (1:1).
P-23-0048A 3 12/28/2022 Dynax Corporation (G) Additive used in industrial and commercial applications (G) Alkenoic acid, reaction products with polyalkenimine, poly-mercapto alkanolester and C6-fluoro haloalkane, compds. with alkanolamine.
P-23-0061 1 12/29/2022 CBI (G) Plastic resin (G) Alkanoic acid, substituted, polymer with substituted alkanoic acid, from fermentation of fermentable sugars.
P-23-0061A 2 01/30/2023 CBI (G) Plastic resin (G) Alkanoic acid, substituted, polymer with substituted alkanoic acid, from fermentation of fermentable sugars.
P-23-0064 1 01/09/2023 CBI (G) Component in aerospace coatings (G) Alkanediol, substituted, polymer with diisocyanatoalkane, substituted heterocycle-modified.
P-23-0065 1 01/11/2023 Cytec Industries, Inc (G) Industrial process chemical (G) Alkyl acid, 2-hydroxy-, methyl substituted alkyl ester.
P-23-0066 1 01/17/2023 CBI (G) An antioxidant additive (G) alkylated phenyl-naphthalene amine.
P-23-0068 4 01/30/2023 US Polymers Accurez, LLC (S) Ingredient in industrial primers and topcoats (S) 1,3-Isobenzofurandione, hexahydro-, polymer with 1,4-cyclohexanedimethanol, isononanoate.
P-23-0071 1 01/18/2023 Colonial Chemical, Inc (S) Water based metalworking fluids, Metal cleaner (G) alkyl dicarboxylic acid, compound with 2,2′,2″-nitrilotris[ethanol] (1:?).
P-23-0073 1 01/24/2023 Heraeus Epurio, LLC (S) Use as a photoacid generator for photoresist applications (S) Methanesulfonic acid, 1,1,1-trifluoro-, 1,3-dioxo-1H-benz[de]isoquinolin-2(3H)-yl ester.
P-23-0074 1 01/24/2023 BASF Corporation (S) Monomer used in the production of polymers (S) 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters.
P-23-0075 1 01/25/2023 Colonial Chemical, Inc (S) Lubricant additive, water based cutting fluids, institutional cleaning products, and cleaning in place applications (G) Surfactant used in personal care products (G) Amides, vegetable oil, hydroxylated amine, amides, soya, hydroxylated amine.
P-23-0076 1 01/26/2023 CBI (G) Dyestuff (G) 1,5-Carbopolycycle disulfonic acid, 2-[2-[8-[[4-chloro-6-(ethylcarbomonocyclic amino)-heteromonocyclic]amino]-1-hydroxy-3,6-disulfo-2-carbopolycyclic]diazenyl]-, sodium salt (1:4).
SN-23-0002 2 12/30/2022 CBI (G) The LCPFACs have no function or application (S) Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-pentadecafluoro-.
SN-23-0003 2 12/30/2022 CBI (G) The LCPFACs have no function or application (S) Dodecanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12-tricosafluoro-.
SN-23-0004 2 12/30/2022 CBI (G) The LCPFACs have no function or application (S) Nonanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluoro-.
SN-23-0005 2 12/30/2022 CBI (G) The LCPFACs have no function or application (S) Decanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-nonadecafluoro-.
SN-23-0006 2 12/30/2022 CBI (G) The LCPFACs have no function or application (S) Undecanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,11-heneicosafluoro-.
SN-23-0007 3 01/09/2023 Allnex USA, Inc (S) EBECRYL MPDDA is a difunctional acrylated monomer which polymerizes when exposed to sources of free radicals such as application in UV/EB cured inks, additive manufacturing, adhesives, composites, 3D printing and coatings systems, and is used as an additive where improved elasticity, weathering, and adhesion are desired in combination with an excellent water resistance (S) 2-Propenoic acid, 1,1′-(3-methyl-1,5-pentanediyl) ester.
SN-23-0008 2 12/30/2022 CBI (G) The LCPFACs have no function or application (S) Tetradecanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14-heptacosafluoro-.
SN-23-0009 2 12/30/2022 CBI (G) The LCPFACs have no function or application (S) Tridecanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,13-pentacosafluoro-.
SN-23-0010 2 12/30/2022 CBI (G) The LCPFACs have no function or application (S) Hexadecanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16-.hentriacontafluoro-
SN-23-0011 2 12/30/2022 CBI (G) The LCPFACs have no function or application (S) Octadecanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,17,17,18,18,18-pentatriacontafluoro-.
SN-23-0012 4 01/04/2023 Dynax Corporation (G) Additive used in industrial and commercial applications (G) Polyfluorinated alkyl polyamide.

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 01/01/2023 to 01/31/2023

Case No. Received date Commencement date If amendment, type of amendment Chemical substance
J-22-0015 01/09/2023 01/06/2023 N (G) Modified yeast, chromosomally and stably modified to improve fermentation performance.
P-15-0691A 01/24/2023 07/21/2022 Amended generic chemical name (G) Polyamidoamine with substituted ethyleneamine, sodium salt.
P-15-0734A 01/24/2023 08/01/2022 Amended generic chemical name (G) Polyamidoamine with substituted ethyleneamine, n-carbodithioate, sodium salt.
P-17-0235 01/11/2023 11/28/2022 N (G) Amidoamine quaternary ammonium salt.
P-19-0186 01/18/2023 01/18/2023 N (S) Benzoic acid, 2-chloro-5-methyl-, sodium salt (1:1).
P-21-0137 01/09/2023 09/09/2022 N (G) Triazine-trione, tris(isocyanatoalkyl)-, polymer with substituted diisocyanato alkylcarbomonocycle, ydro-hydroxypoly(oxyalkanediyl) and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], aliphatic alkyl amine-blocked.
P-21-0138 01/30/2023 01/17/2023 N (G) Lithium metal oxide.
P-21-0176 01/30/2023 12/29/2022 N (S) Dodecanedioic acid, 1,12-bis[2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl]ester.
P-97-0954 01/13/2023 10/23/2020 N (G) Polymeric, alcohol-blocked aromatic isocyanate.
* 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.

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 01/01/2023 to 01/31/2023

Case No. Received date Type of test information Chemical substance
P-14-0712 01/11/2023 Polychlorinated Dibenzodioxins and Polychlorinated dibenzofurans Testing (S) Waste plastics, pyrolyzed, C5-55 fraction.
P-16-0543 01/18/2023 Exposure Monitoring Report (G) Halogenophosphoric acid metal salt.
P-16-0543 01/06/2023 Exposure Monitoring Report (G) Halogenophosphoric acid metal salt.
P-18-0168 01/27/2023 Surface Tension Testing (G) Alkoxylated triaryl methane.

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 13, 2023.

Pamela Myrick,

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

[FR Doc. 2023-03362 Filed 2-16-23; 8:45 am]

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