Certain New Chemicals; Receipt and Status Information for May 2024

Federal RegisterJul 11, 2024

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2024-0057; FRL-11683-05-OCSPP]

Certain New Chemicals; Receipt and Status Information for May 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 5/01/2024 to 5/31/2024.

DATES:

Comments identified by the specific case number provided in this document must be received on or before August 12, 2024.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2024-0057, through the

Federal eRulemaking Portal

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 5/01/2024 to 5/31/2024. 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/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?

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.

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 5/01/2024 to 5/31/2024

Case No.

Version

Received date

Manufacturer

Use

Chemical substance

J-24-0005

04/23/2024

Cargill, Incorporated

(G) Production of biofuel

(G) Biofuel-producing modified microorganism(s), with chromosomally borne modifications.

J-24-0006

04/23/2024

Cargill, Incorporated

(G) Production of biofuel

(G) Biofuel-producing modified microorganism(s), with chromosomally borne modifications.

J-24-0007

04/23/2024

Cargill, Incorporated

(G) Production of biofuel

(G) Biofuel-producing modified microorganism(s), with chromosomally borne modifications.

J-24-0008

04/23/2024

Cargill, Incorporated

(G) Production of biofuel

(G) Biofuel-producing modified microorganism(s), with chromosomally borne modifications.

P-20-0144A

05/08/2024

CBI

(G) Asphalt emulsion applications

(S) Fatty acids, soya, reaction products with polyethylenepolyamines.

P-21-0165

05/02/2024

Colonial Chemical, Inc

(S) Anionic surfactant in cleaning products

(S) D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 3-(3,4-dicarboxy-3-hydroxy-1-oxobutoxy)-2-hydroxypropyl ethers, sodium salts.

P-23-0084

05/02/2024

Colonial Chemical, Inc

(S) Institutional cleaning products, hard surface cleaners, and cleaning in place applications

(G) Amides, vegetable oil, hydroxylated amine.

P-23-0085

05/02/2024

Colonial Chemical, Inc

(S) Institutional cleaning products, hard surface cleaners, and cleaning in place applications

(G) Amides, soya, hydroxylated amine.

P-23-0173A

05/10/2024

CBI

(G) Component used in battery manufacturing

(G) Cellulose, alkoxyalkyl ether, alkali metal salt.

P-23-0173A

05/28/2024

CBI

(G) Component used in battery manufacturing

(G) Cellulose, alkoxyalkyl ether, alkali metal salt.

P-23-0174A

05/28/2024

CBI

(G) Component used in battery manufacturing

(G) Mixed metal oxide.

P-24-0027

05/29/2024

Mikros Biochem

(S) Surfactant for cleaners

(S) Fatty acids, C8-14, 2,3-diesters with rel-(2R, 3S)-2,3,4-trihydroxybutyl Beta-D-mannopyranoside acetate.

P-24-0092

05/02/2024

Colonial Chemical, Inc

(S) Institutional cleaning products, hard surface cleaners, and cleaning in place applications

(G) Fatty acid reaction products with diisopropanolamine.

P-24-0111A

05/24/2024

CBI

(S) Hardener for use in paints, coatings, and adhesives

(G) Formaldehyde, polymer with aminoalkyl-(aminoalkyl)amino(alkyl)-alkaneamine, alkanediylbis(oxyalkylene)(oxirane), 4,4′-(1-methylethylidene)bis[phenol] and 2,2′-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bis[oxirane], modified with (aminoalkyl)amino(alkyl)amino-phenoxy-alkanol and alkyl modified-ether, salts.

P-24-0113A

05/08/2024

CBI

(S) Adhesion and curing agent for use in paints and adhesives

(G) Epoxidized D-glucitol.

P-24-0116

05/09/2024

CBI

(G) For use in coatings for metal parts

(G) Phenol, 4,4-(1-alkylidene)bis-, polymer with 2-(chloromethyl)oxirane, 4-alkylphenyl ether, reaction products with alkylpolyamine and 2-(alkylamino)alkanol, hydrolyzed, alkanesulfonates (salts).

P-24-0117

05/09/2024

CBI

(G) For use in coatings for metal parts

(G) Alkanoic acid, compds. with hydrolyzed bisphenol-epichlorohydrin polymer 4-alkylphenyl ether- alkylpolyamine and 2-(alkylamino)alkanol reaction products.

P-24-0118

05/09/2024

CBI

(G) For use in coatings for metal parts

(G) Alkanoic acid, compds. with [(aminoalkyl)imino]bis[alkanol]-bisphenol-epichlorohydrin polymer 4-alkylphenyl ether—2-(alkylamino)alkanol reaction products.

P-24-0119

05/09/2024

CBI

(G) For use in coatings for metal parts

(G) Amidosulfonic acid, compds. with with [(aminoalkyl)imino]bis[alkanol]-bisphenol-epichlorohydrin polymer 4-alkylphenyl ether—2-(alkylamino)alkanol reaction products.

P-24-0120

05/09/2024

CBI

(G) For use in coatings for metal parts

(G) Alkanoic acid, compds. with hydrolyzed bisphenol-monoalkylamine-epichlorohydrin polymer 4-alkylphenyl ether-alkylpolyamine and 2-(alkylamino)alkanol reaction products.

P-24-0121

05/09/2024

CBI

(G) For use in coatings for metal parts

(G) Phenol, 4,4-(1-alkylidene)bis-, polymer with 2-(chloromethyl)oxirane and monoalkanamine, 4-alkylphenyl ether, reaction products with alkylpolyamine and 2-(alkylamino)alkanol, hydrolyzed, alkanesulfonates (salts).

P-24-0127

05/14/2024

CBI

(S) Hardener for use in paints, coatings, and adhesives

(G) Phenol, polymer with bisphenol A, modified bisphenol A, epichlorohydrin, modified phenoxyalkyl and alkylamine, acetate (salt).

P-24-0128

05/29/2024

CBI

(S) Chemical intermediate

(G) Tetramethyldisiloxanediylbis[propylcarbonyl].

P-24-0130A

05/13/2024

CBI

(S) Sulfur Scavenger

(G) Poly(alkoxy)alkanol.

P-24-0133

05/02/2024

Wacker Chemical Corporation

(G) Thread and textile treatment

(S) Siloxanes and Silicones, di-Me, hydrogen-terminated, polymers with 1,6-diisocyanatohexane and polyethylene glycol monoallyl ether, N3-[3-(dimethylamino)propyl]-N1,N1-dimethy1-1,3-propanediamine-blocked.

P-24-0135A

05/02/2024

ArrMaz Products, Inc

(S) Anti-caking additive

(S) Phosphoric acid, mono- and di-C16-18-alkyl esters.

P-24-0136

05/28/2024

CBI

(G) Crosslinking polymer

(G) Siloxanes and Silicones, di-Me, polymers with silicic acid, [(ethenyldimethylsilyl)oxyl]-terminated, reaction products with [(alkoxysilyl)ethyl]siloxane and [(alkoxysilyl)ethyl]siloxane.

P-24-0139

05/14/2024

CBI

(G) Automotive refinish coating

(G) Maleic acid, dibutyl ester, reaction products with isophoronediamine-5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane-trimethylolpropane triacrylate polymer, di-Bu maleate and di-Et maleate.

P-24-0141

05/01/2024

CBI

(G) Fuel additive

(G) 2-Propenoic acid, reaction products with alkylamine.

P-24-0142

04/21/2024

Samsung SDI America, Inc

(S) Leveling agent used in semiconductor manufacturing

(G) 2-alkenoic acid fluorinated ester, polymer with alkyloxirane homopolymer monoether with 1,2-alkanediol, mono-alkenoate, alkylperoxoate initiated.

P-24-0144

05/13/2024

CBI

(G) Industrial Raw Material

(G) Unsaturated carboxylic acid copolymer with 2-Methyl substituted poly(ethylene glycol) diol.

P-24-0145

05/14/2024

CBI

(G) Automotive refinish coating

(G) 2-Butenedioic acid (2Z)-, 1,4-bis(2-ethylhexyl) ester, reaction products with 5-amino-1,3,3-trimethylcyclohexanemethanamine-hexamethylene diacrylate-isophorone diisocyanate polymer and di-Bu maleate.

P-24-0145A

05/24/2024

CBI

(G) Automotive refinish coating

P-24-0147

05/02/2024

CBI

(G) Component used in drilling operations

(G) Vinylhalo dialkylester, Vinylhalo dialkylester, Vinylhalo dialkylester;.

P-24-0148

05/06/2024

CBI

(G) Display Material

(G) Substituted polyphenyl, alkyl-fluoro-alkyl.

P-24-0149

05/06/2024

CBI

(G) Display Material

(G) Substituted polyphenyl, alkyl-polyfluoro-alkyl-.

P-24-0150

05/06/2024

CBI

(G) Display Material

(G) Substituted polyphenyl, alkyl-alkyl-polyfluoro-.

P-24-0151

05/06/2024

CBI

(G) Display Material

(G) Substituted polyphenyl, alkyl-alkyl-fluoro-.

P-24-0152

05/08/2024

CBI

(G) Display Material

(G) Phenyl carboxylic acid, alkylcycloalkyl, phenylalkanediyl ester.

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 5/01/2024 to 5/31/2024

Case No.

Received date

Commencement date

If amendment, type of

amendment

Chemical substance

P-18-0014

05/01/2024

04/22/2024

(G) Sulfonium, triphenyl-, salt with disubstituted-heterocyclic compound (1:1).

P-18-0223

05/16/2024

05/13/2024

(S) Heptane, 3,3-bis(methoxymethyl)-2,6-dimethyl-.

P-20-0122

05/01/2024

04/22/2024

(G) Heterocyclic onium compound with 1-substituted-alkyl 2,2,2-trisubstitutedalkyl 2-methyl-2-propenoate (1:1), polymer with acenaphthylene, 4- ethenyl-a,a-dimethylbenzenemethanol and 4-ethenylphenyl acetate, hydrolyzed.

P-20-0168

05/22/2024

05/17/2024

(G) Polyolefin polyamine succinimide, carbopolycycle alkoxylated.

P-22-0030

05/10/2024

05/03/2024

(G) Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4-isocyanatobenzene].

P-22-0080

05/03/2024

04/05/2024

(S) Poly(oxy-1,2-ethanediyl),,'-(iminodi-2,1-ethanediyl)bis[-(2-aminoethoxy)-.

P-22-0080

05/03/2024

04/05/2024

(S) Poly(oxy-1,2-ethanediyl),-(2-aminoethyl)—(2-aminoethoxy)-.

P-22-0086

05/02/2024

04/09/2024

(G) Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri- carbopolycycle, hetero-acid)benzenesulfonate (1:1).

P-22-0131

05/10/2024

05/09/2024

(S) Maltodextrin, hexadecanoate.

P-22-0132

05/10/2024

05/09/2024

(S) Maltodextrin, decanoate.

P-22-0133

05/10/2024

05/09/2024

(S) Maltodextrin, octadecanoate.

P-22-0139

05/02/2024

04/20/2024

(G) Dialkylhydroxylamine.

P-22-0157

05/28/2024

(S) 1,2-ethanediamine, n,n-dimethyl-n-(1-methylethyl)-n-[2-[methyl(1-methylethyl)amino]ethyl]-.

P-23-0061

05/22/2024

04/25/2024

(G) Alkanoic acid, substituted, polymer with substituted alkanoic acid, from fermentation of fermentable sugars.

P-23-0104

05/16/2024

04/17/2024

(G) Sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic ester.

P-23-0176

05/16/2024

04/17/2024

(G) Sulfonium, bis(dihalo carbomonocycle)carbomonocycle-, salt with dihalo-sulfoalkyl trisubstituted benzoate

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 5/01/2024 to 5/31/2024

Case No.

Received date

Type of test Information

Chemical substance

L-23-0189

05/16/2024

Air Monitoring Test Data

(S) 1-propene, 3,3-diethoxy-.

L-24-0004

05/21/2024

Allyl Chlorid PEL TWA & STEL Monitoring Test Data

(G) 3-alkene, 1-chloro-, (3z)-.

LM-24-0003

05/04/2024

Algal Toxicity (OECD Test Guideline 201); Freshwater and Saltwater Fish Acute Toxicity Test (OECD Test Guideline 203); Bacterial Reverse Mutation Test (OECD Test Guideline 471); Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids (OECD Test Guideline 202)

(G) Urea, (dialkylsubstituted)alkyl)-, polymer with polyether dialkanesalt.

P-07-0087

05/28/2024