2022-01304. Certain New Chemicals; Receipt and Status Information for December 2021

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is required under the Toxic Substances Control Act (TSCA) to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA, 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 12/01/2021 to 12/31/2021.

DATES:

Comments identified by the specific case number provided in this document must be received on or before February 23, 2022.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0068, and the specific case number for the chemical substance related to your comment, 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 or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is open to visitors by appointment only. For the latest status information on EPA/DC services and docket access, visit 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: [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

A. What action is the Agency taking?

This document provides the receipt and status reports for the period from 12/01/2021 to 12/31/2021. 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/​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 https://www.epa.gov/​dockets/​comments.html.

II. Status Reports

Given public interest in information on the status of TSCA 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 TSCA 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 12/01/2021 to 12/31/2021

Case No.	Version	Received date	Manufacturer	Use	Chemical substance
J-22-0008	1	11/18/2021	CBI	(G) Manufacture of an alcohol	(G) Modified Yeast.
J-22-0009	1	12/10/2021	Danisco US, Inc	(G) Production of a chemical substance	(G) Genetically modified microorganism for the production of a chemical substance.
J-22-0010	1	12/10/2021	Danisco US, Inc	(G) Production of a chemical substance	(G) Genetically modified microorganism for the production of a chemical substance.
P-18-0097A	3	12/23/2021	Mane USA	(G) Ingredient	(S) 1,3-Dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethly-.
P-18-0293A	14	12/28/2021	Sirrus, Inc	(S) Intermediate: Monomer used as a chemical intermediate in the manufacture of polymers (G) Coatings: Monomer used in the manufacture of industrial coatings ( e.g., protective floor coatings). The PMN substance ( i.e., unreacted monomer) is not used in spray applications. Adhesives: Monomer used in the manufacture (formulation) ( e.g., reactive, industrial structural or lamination)	(S) Propanedioic acid, 2-methylene-, 1,3-dihexyl ester.
P-18-0294A	14	12/28/2021	Sirrus, Inc	(S) Intermediate: Monomer used as a chemical intermediate in the manufacture of polymers. (G) Coatings: Monomer used in the manufacture of industrial coatings ( e.g., protective floor coatings). The PMN substance ( i.e., unreacted monomer) is not used in spray applications. Adhesives: Monomer used in the manufacture (formulation) of ( e.g., reactive, industrial structural or lamination)	(S) Propanedioic acid, 2-methylene-, 1,3-dicyclohexyl ester.
P-21-0101A	2	12/13/2021	ENI trading & shipping INC	(G) Used as a lubricant and lubricant additive	(G) Benzenesulfonic acid, polyalkyl derivs., calcium salts.
P-21-0133A	6	12/01/2021	CBI	(S) Chemical Intermediate	(G) Distillation bottoms from manufacture of alkanoic acid by organic acid-producing organism, modified.
P-21-0141A	5	12/23/2021	Valero Energy Corporation	(S) Transportation Fuel	(S) Alkanes, C4-8—Branched and Linear.
P-21-0168A	3	12/23/2021	CBI	(G) Colorant	(G) Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino]sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium salts.
P-21-0169	3	12/15/2021	CBI	(G) Additive for plastic	(G) Fatty acids, penta-alkyl-4-piperidinyl esters.
P-21-0182A	3	12/01/2021	CBI	(S) chemical intermediate	(G) Distillation bottoms from manufacture of alkanoic acid by organic acid-producing organism.
P-21-0183A	3	12/01/2021	CBI	(S) chemical intermediate	(G) Distillation bottoms from manufacture of alkanoic acid by organic acid-producing organism, modified.
P-21-0190A	3	12/07/2021	Santolubes Manufacturing LLC	(S) This product will be used in gear oils & greases, wind turbines, HX-1 (incidental food contact) lubricants and EV (Electric Vehicle) motors. It will be used by OEMs in these applications as components in finished formulations. The intended use of these products is 100% industrial and not intended for use as consumer products	(S) Poly(oxy-1,2-ethanediyl)-alpha-(1-oxohexyl)-omega-[(1-oxohexyl)oxy]-.
P-21-0193A	4	12/07/2021	Santolubes Manufacturing LLC	(S) This product will be used in gear oils & greases, wind turbines, HX-1 (incidental food contact) lubricants and EV (Electric Vehicle) motors. It will be used by OEMs in these applications as components in finished formulations. The intended use of these products is 100% industrial and not intended for use as consumer products	(S) Fatty acids, C8-10, diesters with polyethylene glycol.
P-21-0201A	8	12/09/2021	The Lewis Chemical Company	(S) The intention is for this product to be used as an offset to N,N,N′,N′,N′-Pentamethyl-N-tallow alkyl1,3- propanediammonium chloride (CAS#68607-29-4) in a cationic latex asphalt emulsion formulation	(S) 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-9-octadecen-1-yl, chloride (1:2); (S) 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecyl-, chloride (1:2); (S) 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-tetradecyl-, chloride (1:2); (S) 1,3-Propanediaminium, N-hexadecyl-2-hydroxy-N,N,N′,N′,N′-pentamethyl-, dichloride (2CI);.
P-21-0201A	9	12/20/2021	The Lewis Chemical Company	(S) The intention is for this product to be used as an offset to N,N,N',N',N”-Pentamethyl-N-tallow alkyl1,3- propanediammonium chloride (CAS#68607-29-4) in a cationic latex asphalt emulsion formulation	(S) 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecen-1-yl, chloride (1:2); (S) 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecyl-, chloride (1:2); (S) 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-tetradecyl-, chloride (1:2); (S) 1,3-Propanediaminium, N-hexadecyl-2-hydroxy-N,N,N′,N′,N′-pentamethyl-, dichloride (2CI);.
P-21-0216A	2	12/10/2021	CBI	(G) Additive in electrode materials. (G) Additive in plastics	(G) Multi-walled carbon nanotubes.
P-21-0217A	2	12/10/2021	CBI	(G) Additive in electrode materials. (G) Additive in thermoplastics. (G) Component in electrodes	(G) Multi-walled carbon nanotubes.
P-22-0003	2	12/10/2021	INV Nylon Chemicals Americas, LLC	(S) Clay Stabilizer in Oil & Gas Fracking	(S) 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2).
P-22-0004	2	12/10/2021	INV Nylon Chemicals Americas, LLC	(S) Clay Stabilizer in Oil & Gas Fracking	(S) 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1).
P-22-0005	2	12/10/2021	INV Nylon Chemicals Americas, LLC	(S) Clay Stabilizer in Oil & Gas Fracking	(S) Formic acid, compd. with 2-methyl-1,5-pentanediamine (2:1).
P-22-0006	2	12/10/2021	INV Nylon Chemicals Americas, LLC	(S) Clay Stabilizer in Oil & Gas Fracking	(S) Formic acid, compd. with 2-methyl-1,5-pentanediamine (1:1).
P-22-0007	3	12/22/2021	CBI	(S) This compound will be used as a crosslinker in formulating general purpose sealants and adhesives for use in consumer and professional markets. The crosslinker reacts in the presence of moisture to cure a sealant	(G) 3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester.
P-22-0008A	3	12/20/2021	CBI	(G) Biocatalyst used in a variety of products	(S) .beta.-N-Acetylhexosaminidase.
P-22-0009	2	12/02/2021	CBI	(S) Gasoline blending component to reduce the average carbon intensity and subsequent CO2 emissions of fuel	(S) Alkanes, C4-C9-branched and linear.
P-22-0009A	3	12/07/2021	CBI	(S) Gasoline blending component to reduce the average carbon intensity and subsequent CO2 emissions of fuel	(S) Alkanes, C4-C9-branched and linear.
P-22-0011	2	11/30/2021	Lord Corporation	(G) Functionalized rubber in resin side of two component epoxy modified acrylic adhesive. (G) Functionalized rubber in resin side of two component acrylic adhesive	(G) Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-[(1-oxo-2-propen-1-yl)oxylethyl]carbamates].
P-22-0013	1	12/02/2021	Corteva Agriscience LLC	(S) Raw Material/Intermediate, Site-Limited, Destructive Use	(G) 2-pyridinecarboxylic acid, 3-halo,4-nitrogen-substituted-5-halo-6-halo, aryl ester.
P-22-0015	2	12/16/2021	Corteva Agriscience LLC	(S) Raw Material, Site-Limited, Destructive Use	(G) 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo-.
P-22-0016	1	12/13/2021	CBI	(G) Complexing agent	(G) Alkyl glycine dicarboxylic acid sodium salt.
P-22-0017	1	12/14/2021	Sasol Chemicals (USA) LLC	(S) Paraffin wax substitute for candles. (S) Alkylate for polymer esters	(S) 1—Eicosanol, manuf. of, distn., residues.
P-22-0018	1	12/14/2021	CBI	(G) Component of lubricant	(G) Substituted polyalkylenepoly, reaction products with substituted heteromonocycle substituted heteromonocycle polyalkylene derivs.
P-22-0019	1	12/16/2021	CBI	(G) Film-forming polymer	(G) Protein sodium complexes, polymers with aromatic acid chloride, ethylene diamine and amino acid.
P-22-0021	1	12/17/2021	CBI	(G) Nucleating Agent for Polyolefins	(G) Alkylphosphonic acid, calcium salt.
P-22-0023	1	12/21/2021	CBI	(G) Catalyst system component	(G) Alkyldioic acid, bis(alkylalkyl)-, polyalkyl ester.
P-22-0026	1	12/23/2021	CBI	(G) Emulsifier for industrial uses	(G) Polyalkylamines, reaction products with maleated glycerides.
SN-21-0013	2	11/30/2021	Koch Agronomic Services	(S) Additive for urea ammonium nitrate, UAN, fertilizer for boom spray applications	(S) Urea, reaction products with N-butylphosphorothioic triamide and formaldehyde.
SN-22-0002	1	12/17/2021	Eastman Chemical Company, INC	(S) Solvent-borne coatings (S) Coatings for consumer use, brush on coatings (S) Coatings for commercial use, spray coating (G) Consumer use other than brush on	(S) 2-Pyrrolidinone, 1-butyl-.
* 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 12/01/2021 to 12/31/2021

Case No.	Received date	Commencement date	If amendment, type of amendment	Chemical substance
P-16-0110	12/20/2021	12/17/2021	N	(G) Heteropolycycle hydrogen carbonate, polycondensate with alkyl hydrogen carbonate.
P-16-0349	12/10/2021	11/21/2021	N	(G) Quaternary ammonium salt of polyisobutene succinic acid.
P-16-0430	11/29/2021	11/24/2021	N	(S) Pentanedioic acid, 2-methyl-.
P-18-0284	12/06/2021	11/29/2021	N	(G) Inorganic acid, reaction products with alkyl alcohol.
P-20-0058	12/01/2021	11/15/2021	N	(S) Maltodextrin, polymer with 2-propenoic acid and n,n,n-trimethyl-2-[(2-methyl-1-oxo-2-propen-1- yl)oxy]ethanaminium chloride (1:1), sodium salt, peroxydisulfuric aci d ([(HO)S(O)2]2O2) sodium salt (1:2)-initiated.
P-20-0064	12/16/2021	12/13/2021	N	(S) Multi-walled carbon nanotubes; closed; 7.9-14.2 nm diameter; bundle length 9.4-106.4 µm; Grade: jenotube 10.
P-20-0105	12/16/2021	11/24/2021	N	(S) 4h-Pyran-4-one, 3-[(2,5-dihydro-4-methyl-5-oxo-2-furanyl)oxy]-2-methyl-.
P-21-0063	12/21/2021	11/29/2021	N	(G) Heterocyclic-polycarboxylic acid, polyhaloaryl-polyhydro-alkyl-polyalkyl 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 12/01/2021 to 12/31/2021

Case No.	Received date	Type of test information	Chemical substance
P-14-0712	11/29/2021	Quarterly PCDD/F Test of PMN Substance using EPA Test Method 8290A	(S) Waste plastics, pyrolyzed, C5-55 fraction.
P-14-0712	12/20/2021	Quarterly PCDD/F Test of PMN Substance using EPA Test Method 8290A	(S) Waste plastics, pyrolyzed, C5-55 fraction.
P-16-0543	11/28/2021	Exposure Monitoring Report	(G) Halogenophosphoric acid metal salt.
P-18-0413	12/16/2021	Freezing Point Test (OECD Test Guideline 102), Boiling Point Test (OECD Test Guideline 103), Relative Density Test (OECD Test Guideline 109), Vapor Pressure Test (OECD Test Guideline 104), Water Solubility Test (OECD Test Guideline 105), N-octanol/Water Partition Coefficient (Log Kow) Test (OECD Test Guideline 107), pH Test (CIPAC Method MT 75.3), Surface Tension Test (OECD Test Guideline 115), Dissociation Constant Test (OECD Test Guideline 112), Viscosity Test (OECD Test Guideline 114), Auto-ignition Temperature Test (EC A.15), Flash Point Test (EC A.9), Explosive Properties Test (EC A.14), Oxidizing Properties Test (EC A.21), Ready Biodegradability Test (OECD Test Guideline 301C), Inherent Biodegradability Test (OECD Test Guideline 302C), Hydrolysis Test (OECD Test Guideline 111), Absorption/Desorption (Log Koc): HPLC Screening (OECD Test Guideline 121), Absorption/Desorption (Log Koc): Study in Soils (OECD Test Guideline 106), Algal Growth Inhibition Test (OECD Test Guideline 201), Acute Toxicity Daphnids Test (OECD Test Guideline 202), Acute Toxicity to Fish Test (OECD Test Guideline 203), Activated Sludge Respiration Inhibition Test (OECD Test Guideline 209), Chronic Toxicity to Daphnids Test (OECD Test Guideline 211), Chronic Toxicity to Fish Test (OECD Test Guideline 210), Acute Oral Toxicity Test (OECD Test Guideline 425), Acute Dermal Toxicity Test (OECD Test Guideline 402), Acute Inhalation Toxicity Test (OECD Test Guideline 403), Skin Irritation Test (OECD Test Guideline 404), Eye Irritation Test (OECD Test Guideline 405), Skin Sensitization: LLNA Test (OECD Test Guideline 429), In Vitro genotoxicity: Gene Mutation Study in Bacteria (Ames Test) (OECD Test Guideline 471), In Vitro genotoxicity: Cytogenicity Study in Mammalian Cells (Chromosome Aberration Test) (OECD Test Guideline 473), In Vitro genotoxicity: Gene Mutation Study in Mammalian Cells (Mouse Lymphoma Assay) (OECD Test Guideline 490), In Vivo genotoxicity: Micronucleus Study (OECD Test Guideline 474), Repeated Dose Toxicity: 28-Day Study (OECD Test Guideline 407 and 412), Repeated Dose Toxicity: 90-Day Study (OECD Test Guideline 413), and Prenatal Developmental Toxicity Study (OECD Test Guideline 414)	(G) Haloalkyl alkanoate.

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 19, 2022.

Pamela Myrick,

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