2021-02728. Certain New Chemicals; Receipt and Status Information for December 2020

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 12/01/2020 to 12/31/2020.

DATES:

Comments identified by the specific case number provided in this document must be received on or before March 12, 2021.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0077, and the specific case number for the chemical substance related to your comment, by one of the following methods:

• Federal eRulemaking Portal: http://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.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

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: [phone]; email address: [e-mail].

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

SUPPLEMENTARY INFORMATION:

I. Executive Summary

What action is the Agency taking?

This document provides the receipt and status reports for the period from 12/01/2020 to 12/31/2020. 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: http://www.epa.gov/​oppt/​newchems.

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 http://www.epa.gov/​dockets/​comments.html.

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 12/01/2020 to 12/31/2020

Case No.	Version	Received date	Manufacturer	Use	Chemical substance
J-21-0002	2	12/02/2020	CBI	(G) Ethanol production	(G) Saccharomyces cerevisiae modified.
J-21-0003	2	12/02/2020	CBI	(G) Ethanol production	(G) Saccharomyces cerevisiae modified.
P-17-0263A	5	12/09/2020	CBI	(G) Most paint formulators will add less than 5% of Borchi Gel NA that contains 50% of the PMN substance to make their formulated product volume. (i.e., 10-gallon batch would contain 0.5 gallon of our product (0.25gal of PMN substance)	(G) Zirconium carboxylates sodium complexes.
P-18-0057A	15	12/08/2020	CBI	(S) a drier accelerator that is used for superior drying performance in solvent-borne and waterborne air-dried paints, inks and coatings	(G) Vanadium Carboxylate.
P-19-0165A	4	12/16/2020	Arboris, LLC	(G) Plasticizer in rubber, Additive for asphalt	(G) Tall oil pitch, fraction, sterol-low.
P-20-0058A	4	12/01/2020	CBI	(G) Additive for automatic dishwashing, Additive for hard surface cleaner	(G) Polysaccharide, polymer with unsaturated carboxylic acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid salt initiated.
P-20-0058A	5	12/08/2020	CBI	(G) Additive for automatic dishwashing, Additive for hard surface cleaner	(G) Polysaccharide, polymer with unsaturated carboxylic acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid salt initiated.
P-20-0078A	3	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine alkyldioate alkyldioate (1:2:1:1).
P-20-0078A	4	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine alkyldioate alkyldioate (1:2:1:1).
P-20-0078A	5	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine alkyldioate alkyldioate (1:2:1:1).
P-20-0079A	3	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine (3:2).
P-20-0079A	4	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine (3:2).
P-20-0079A	5	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine (3:2).
P-20-0080A	6	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Alkyldiamine, aminoalkyl-, hydrochloride (1:3).
P-20-0080A	7	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Alkyldiamine, aminoalkyl-, hydrochloride (1:3).
P-20-0081A	6	12/28/2020	Ascend Performance Materials	(G) A stabilizer for industrial applications	(G) Carboxylic acid, compd. with aminoalkyl-alkyldiamine (3:1).
P-20-0081A	7	12/28/2020	Ascend Performance Materials	(G) A stabilizer for industrial applications	(G) Carboxylic acid, compd. with aminoalkyl-alkyldiamine (3:1).
P-20-0082A	6	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Alkyldiamine, aminoalkyl-, carboxylate (1:3).
P-20-0082A	7	12/28/2020	Ascend Performance Materials	(G) Stabilizer for industrial applications	(G) Alkyldiamine, aminoalkyl-, carboxylate (1:3).
P-20-0128A	2	12/16/2020	CBI	(G) Additive in Household consumer products	(S) 2-Oxiraneacetic acid, 3-ethyl-, 1-(3,3 dimethylcyclohexyl)ethyl ester.
P-20-0169A	4	11/30/2020	CBI	(G) Battery Plastics and coatings applications, Conductive agent for conductive plastic and paint	(S) multiwalled carbon nanotube.
P-20-0173A	2	12/07/2020	ICM Products Inc	(G) Use as a Coating Additive	(G) Silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated.
P-20-0180A	2	12/09/2020	Evonik Degussa Corporation	(S) Curing agent for Industrial epoxy Composite	(S) Cyclohexanemethanamine,5-amino-1,3,3-trimethy-, N-sec-Bu dervis.
P-21-0010	3	12/16/2020	Evonik Degussa Corporation	(S) 3D Printing	(S) 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2-(hydroxymethyl)- 1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-trimethyl-5-[[[[2-[(1-oxo-2-propen-1- yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.
P-21-0021	4	12/16/2020	J6 Polymers	(S) Raw material to be blending into R-side components of the polyurethane and polyisocyanurate industry. Specifically used in slabstock/bunstock processing of foam	(S) Soybean oil, mixed esters with diethylene glycol, phthalic acid and terephthalic acid.
P-21-0024	2	12/07/2020	CBI	(G) lamination catalyst	(G) Sulfur acid, compd. with bis-alkanolamine (1:1).
P-21-0025	2	12/07/2020	CBI	(G) lamination catalyst	(G) Sulfur acid, compd. with bis-alkanolamine (1:1).
P-21-0026	2	12/07/2020	CBI	(G) lamination catalyst	(G) Sulfur acid, compd. with bis-alkanolamine (1:1).
P-21-0031	2	12/10/2020	Omnium International	(S) Used as a component in a mineral oil based anticorrosion oil. Two applications for the anticorrosion oil are for use in cavities, interiors and closed systems and for protection of large metal parts against corrosion	(S) Isooctadecanoic acid, compd. with N-cyclohexylcyclohexanamine (1:1).
P-21-0037	1	12/11/2020	Sinova Specialties, Inc	(S) Used as a viscosity modifier in commercial and consumer engine oil	(S) [1,1′-Biphenyl]-3,3′,4,4′-tetracarboxamide, N3,N3′,N4,N4′-tetraoctyl.
P-21-0038	1	12/11/2020	Sinova Specialties, Inc	(S) Used as a viscosity modifier in commercial and consumer engine oil	(S) [1,1′-Biphenyl]-3,3′,4,4′-tetracarboxamide, N3, N3′, N4, N4′-tetradodecyl-.
P-21-0039	1	12/11/2020	Sinova Specialties, Inc	(S) Part of a series of chemicals used as viscosity modifiers in commercial and consumer engine oil	(S) 1,2,4,5-Benzenetetracarboxamide, N1, N2, N4, N5-tetrahexyl-.
P-21-0040	1	12/11/2020	Sinova Specialties, Inc	(S) Part of a series of chemicals used as viscosity modifiers in commercial and consumer engine oil	(S) 1,2,4,5-Benzenetetracarboxamide, N1,N2,N4,N5-tetraoctyl-.
P-21-0041	1	12/11/2020	Sinova Specialties, Inc	(S) Part of a series of chemicals used as viscosity modifiers in commercial and consumer engine oil	(S) 1,2,4,5-Benzenetetracarboxamide, N1,N2,N4,N5-tetradodecyl-.
P-21-0042	1	12/15/2020	CBI	(G) Photolithography	(G) Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-(alkyl)carbomonocyclic carboxylate (1:1).
P-21-0043	1	12/16/2020	Advanced Polymer Coatings	(S) Component in protective coatings that provides chemical resistance	(G) Glycidyl ether of (formaldehyde, polymer with mixed phenols).
P-21-0044	1	12/17/2020	CBI	(G) Monomer	(G) Alkenoic acid, polyhaloalkyl ester.
P-21-0045	1	12/17/2020	CBI	(G) Monomer	(G) Alkenoic acid, alkyl-substituted, polyhaloalkyl ester.
P-21-0046	1	12/17/2020	CBI	(G) Monomer	(G) Alkanoic acid, polyhalo-, halo-oxo-alkenyl-oxo-alkyl ester.
P-21-0047	1	12/17/2020	CBI	(G) Monomer	(G) Alkenoic acid, halo-substituted-polyhalo-alkyl ester.
P-21-0049	1	12/18/2020	CBI	(G) Monomer	(G) Alkanoic acid, polyhalo-(halo-oxo-alkenyl)oxyalkyl ester.
P-21-0050	1	12/18/2020	CBI	(G) Monomer	(G) Alkenoic acid, halo-polylhaloalkyl ester.
SN-20-0006A	3	12/18/2020	CBI	(G) Color Developer	(S) Phenol, 4,4′-[1-[4-[1-(4-hydroxyphenyl)-1-methylethyl]phenyl]ethylidene]bis-.
SN-21-0001	1	12/07/2020	CBI	(S) Chelating agent for use in hard surface cleaning (and disinfection), Chelating agent for use in laundry detergent	(S) Glycine, N-(carboxymethyl)-N-[2-[(carboxymethyl)amino]ethyl]-, sodium salt (1:3).
SN-21-0001A	2	12/14/2020	CBI	(S) Chelating agent for use in hard surface cleaning (and disinfection), Chelating agent for use in laundry detergent	(S) Glycine, N-(carboxymethyl)-N-[2-[(carboxymethyl)amino]ethyl]-, sodium salt (1:3).
* 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 prior to the start of the 90-day review period, and in no way reflects the final status of a complete submission review.

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 12/01/2020 to 12/31/2020

Case No.	Received date	Commencement date	If amendment, type of amendment	Chemical substance
J-20-0008	12/08/2020	11/19/2020	N	(G) Biofuel producing saccharomyces cerevisiae modified, genetically stable.
P-11-0386	12/23/2020	12/04/2020	N	(S) Nonanoic acid, ammonium salt.
P-14-0412	12/11/2020	12/03/2020	N	(G) Akyl diol, polymer with alkyldiisocycanate,.alpha-hydro-.omega. hydroxypoly(oxy-alkyldiyl), alkyloxirane, oxirane either with diol.
P-17-0086A	12/10/2020	07/31/2020	Withdrew CBI claim	(S) Cyclohexane, 1,4-bis(ethoxymethyl)-, trans-.
P-18-0318	11/30/2020	11/10/2020	N	(S) 1-octadecanaminium, n,n-dimethyl-n-[3-(triethoxysilyl)propyl]-, chloride (1:1).
P-19-0062	12/18/2020	12/15/2020	N	(S) 1-propene, 1-chloro-2,3,3-trifluoro-, (1e)-.
P-19-0082	12/01/2020	12/01/2020	N	(S) Heptanal, 6-hydroxy-2,6-dimethyl-.
P-20-0008	12/11/2020	11/13/2020	N	(G) 7-heteropolycyclicsulfonic acid, 2-[4-[2-[1-[[(2-methoxy-5-methyl-4-sulfophenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]-6-methyl-, compd. with (alkylamino)alkanol and (hydroxyalkyl)amine.
P-20-0046	12/02/2020	10/31/2020	N	(G) Reaction products of alkyl-terminated alkylalumuminoxanes and {[(pentaalkylphenyl-(pentaalkylphenyl)amino)alkyl]alkanediaminato}bis(aralkyl) transition metal coordination compound.
P-20-0048	12/02/2020	10/31/2020	N	(G) Aluminoxanes, me, me group-terminated, reaction products with bis[(1,2,3,4,5, eta)-1-butyl-2,4-cyclopentadien-1-yl]dichlorozirconium.
P-20-0102	12/22/2020	12/17/2020	N	(S) Coal, brown, ammoxidized.
P-20-0143	12/15/2020	11/01/2020	N	(S) Cyclohexanemethanamine, 5-amino-1,3,3-trimethyl-, polymer with alpha-hydro-omega-hydroxypoly(oxy-1,4-butanediyl), 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, and 1,1′-methylenebis[4-isocyanatobenzene].
P-20-0146	12/04/2020	11/12/2020	N	(G) Alkanoic acid, alkyl, carbopolycyclic alkyl ester.
* 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 12/01/2020 to 12/31/2020

Case No.	Received date	Type of test information	Chemical substance
P-13-0679	12/08/2020	Annual Report of Impurities	(G) Fluoroalkyl acrylate copolymer.
P-16-0543	12/18/2020	Exposure Monitoring Report November 2020	(G) Halogenophosphoric acid metal salt.
P-16-0543	12/17/2020	Exposure Monitoring Report October 2020	(G) Halogenophosphoric acid metal salt.
P-21-0018	12/04/2020	Phototransformation of chemicals in Water—Direct Photolysis (OECD Test Guideline 316)	(G) Sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1).

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 14, 2021.

Pamela Myrick,

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