2020-23170. Certain New Chemicals; Receipt and Status Information for September 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 09/01/2020 to 09/30/2020.

DATES:

Comments identified by the specific case number provided in this document must be received on or before November 19, 2020.

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, through the Federal eRulemaking Portal at 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.

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. 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, Information Management 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 09/01/2020 to 09/30/2020. 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 09/01/2020 to 09/30/2020

Case No.	Version	Received date	Manufacturer	Use	Chemical substance
P-16-0345A	7	08/31/2020	CBI	(G) Processing aid	(G) Acrylamide, polymer with methacrylic acid derivatives.
P-16-0370A	5	09/14/2020	CBI	(G) Crosslinker for adhesives and coatings	(G) Methoxy-terminated polysiloxanes.
P-16-0404A	4	09/22/2020	CBI	(G) A colorant for dyeing various synthetic fibers and fabrics. Open, non-dispersive use	(G) Alkyl ester, 2-({4-[2-(trisubstituted phenyl)azo]-5-acetamido-2-substitutedphenyl} (substituted alkoxy)amino).
P-16-0589A	5	09/25/2020	Chemtura Corporation	(G) Synthetic aircraft engine lubricant for contained use Industrial lubricant	(G) Pentaerythritol Ester of Mixed Linear and Branched Carboxylic Acids.
P-17-0193A	3	09/25/2020	Chemtura Corporation	(G) Synthetic lubricant for contained use Industrial lubricant	(G) Dipentaerythritol Ester of Mixed Linear and Branched Carboxylic Acids; (G) Pentaerythritol Ester of Mixed Linear and Branched Carboxylic Acids;.
P-18-0128A	4	09/02/2020	CBI	(G) Surface modifier	(S) Inulin, 2-hydroxy-3-(trimethylammonio)propyl ether, chloride.
P-18-0143A	9	08/29/2020	Huntsman International LLC	(G) Anti-corrosive primer for outdoor industrial applications	(G) Fatty acids, tall-oil polymers with aminoalkyl, dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine fraction, and tris-[(alkylamino) alkyl] phenol.
P-18-0289A	6	09/09/2020	CBI	(G) Gas scrubbing, landfill deodorizing, wastewater deodorizing	(G) 2-(2(methylcaboxymonocyclic)amino)ethoxy)-alcohol.
P-18-0289A	7	09/23/2020	CBI	(G) Gas scrubbing, landfill deodorizing, wastewater deodorizing	(G) 2-(2(methylcaboxymonocyclic)amino)ethoxy)-alcohol.
P-18-0290A	6	09/09/2020	CBI	(G) wastewater deodorizing, Gas scrubbing, Landfill odor neutralizing	(G) Carbomonocylic-oxazolidine.
P-18-0290A	7	09/23/2020	CBI	(G) Gas scrubbing, Landfill odor neutralizing, wastewater deodorizing	(G) Carbomonocylic-oxazolidine.
P-18-0330A	5	09/21/2020	CBI	(G) initiator	(G) Formaldehyde, polymer with alkyl aryl ketone.
P-18-0334A	3	09/22/2020	Sirrus, Inc	(S) Intermediate use	(S) Propanedioic acid, 1,3-dihexyl ester.
P-18-0335A	3	09/22/2020	Sirrus, Inc	(S) Intermediate use	(S) Propanedioic acid, 1,3-dicyclohexyl ester.
P-18-0336A	5	09/22/2020	Sirrus, Inc	(S) Intermediate use	(S) Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-dihexyl ester.
P-18-0337A	5	09/22/2020	Sirrus, Inc	(S) Intermediate use	(S) Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-dicyclohexyl ester.
P-18-0387A	5	09/01/2020	CBI	(G) Plastic Additive	(G) Alkanal, reaction products with alkanediyl bis[alkyl-tris(alkyl-heterocycle)-1,3,5-triazine-2,4,6-triamine and hydrogen peroxide.
P-18-0388A	5	09/01/2020	CBI	(G) Plastic additive	(G) 1,3,5-triazine-2,4,6-triamine, alkanediyl bis[alkyl-tris(alkyl-heterocycle)-, allyl derivs., oxidized, hydrogenated.
P-18-0407A	5	09/08/2020	CBI	(S) Polyurethane catalyst	(S) 1,2-Ethanediamine, N,N-dimethyl-N-(1-methylethyl)-N-[2-[methyl(1-methylethyl)amino]ethyl]-.
P-18-0407A	6	09/15/2020	CBI	(S) Polyurethane catalyst	(S) 1,2-Ethanediamine, N,N-dimethyl-N-(1-methylethyl)-N-[2-[methyl(1-methylethyl)amino]ethyl]-.
P-18-0407A	7	09/21/2020	CBI	(S) Polyurethane catalyst	(S) 1,2-Ethanediamine, N,N-dimethyl-N-(1-methylethyl)-N-[2-[methyl(1-methylethyl)amino]ethyl]-.
P-19-0048A	8	09/23/2020	CBI	(G) Coating additive	(S) Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C12-14-alkyl ethers, phosphates, sodium salts.
P-19-0162A	3	09/18/2020	CBI	(G) Component in Oil Production	(G) fatty acid alkyl amide, (dialkyl) amino alkyl, alkyl quaternized, salts.
P-19-0162A	4	09/29/2020	CBI	(G) Component in Oil Production	(G) fatty acid alkyl amide, (dialkyl) amino alkyl, alkyl quaternized, salts.
P-20-0030A	3	09/10/2020	CBI	(S) Plasticizer for Plastisols, in caulks and sealants	(G) Hexanedioic acid, carbomonocyclic esters.
P-20-0066A	3	09/14/2020	CBI	(G) Antiwear additive for lubricants	(G) 2-Propenoic acid, 2-hydroxyethyl ester, reaction products with dialkyl hydrogen heterosubstituted phosphate and dimethyl phosphonate.
P-20-0073A	5	09/25/2020	CBI	(G) Oil and gas production chemistry	(G) 2,5-Furandione, reaction products with alkylamine, 1-octanol and polyethylene glycol alkoxy-ether, acetates (salts).
P-20-0099A	7	09/15/2020	Materion Advanced Chemicals	(S) A material used for the production of Li ion conductive separators for rechargeable batteries	(G) Mixed Metal Oxide.
P-20-0100A	5	09/02/2020	Evonik Corporation	(S) Manual dish detergent, hard Surface cleaner, laundry detergent	(S) Refer to attachment “Chemical Identity”.
P-20-0100A	6	09/11/2020	Evonik Corporation	(S) Manual dish detergent, hard Surface cleaner, laundry detergent	(G) Rhamnolipids, modified pseudomonas-fermented, from dextrose.
P-20-0108A	4	09/11/2020	CBI	(G) Film-forming polymer	(G) Alkanoic acid, compds. with diphenolmethane derivative-N1,N1-dialkyl-1,3-alkanediamine-epiclorohydrin-2-cyclic ester homopolymer with dialkylene glycol (2:1) polymer-dialkanolamine reaction products.
P-20-0111A	2	09/25/2020	CBI	(G) Component in flexible automotive interior parts	(S) 1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl ester.
P-20-0144	2	09/16/2020	CBI	(G) Asphalt emulsion applications	(S) Fatty acids, soya, reaction products with polyethylenepolyamines.
P-20-0162	2	08/31/2020	CBI	(G) Photolithography	(G) Sulfonium, triaryl-, 3,3,3-trihalo-2-sulfoalkyl polycycloalkane-1-carboxylate (1:1).
P-20-0166	1	08/21/2020	Sun Chemical	(G) Component of ink	(G) Formaldehyde, polymer with 2-methylcarbomonocycle, glycidyl ether, acrylate hydrogen 1,2-carbomonocyledicarboxylate,
P-20-0167	2	08/31/2020	W. R. Grace & Co.—Conn	(G) Catalyst	(G) Phenylene, alkyl and polycarbomonocycle substituted, 1,2-dicarboxylate.
P-20-0168	2	09/14/2020	CBI	(S) Lubricating additives for engine oils, transmission and hydraulic fluid and gear oil applications	(G) Polyolefin polyamine succinimide, carbopolycycle alkoxylated.
P-20-0168A	3	09/22/2020	CBI	(S) Lubricating additives for engine oils, transmission and hydraulic fluid and gear oil applications	(G) Polyolefin polyamine succinimide, carbopolycycle alkoxylated.
P-20-0170	3	09/09/2020	Tetramer Technologies, LLC	(G) Component in Lubricants	(G) Glycerin, alkoxylated alkyl acid esters.
P-20-0171	3	09/09/2020	Tetramer Technologies, LLC	(G) Component in Lubricants	(G) Glycerin, alkoxylated alkyl acid esters.
P-20-0172	3	09/09/2020	Tetramer Technologies, LLC	(G) Component in Lubricants	(G) Glycerin, alkoxylated alkyl acid esters.
P-20-0173	1	09/01/2020	ICM Products Inc	(G) Use as a Coating Additive	(G) Silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated.
P-20-0174	3	09/17/2020	P2 Science, Inc	(S) For use in consumer products, as well as direct addition to consumer products	(S) 6-Octen-1-ol, 3,7-dimethyl-, homopolymer, monoacetate.
P-20-0175	2	09/21/2020	Materia Inc	(G) Resin formulation additive	(G) acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, methyl ester.
P-20-0176	2	09/21/2020	Materia Inc	(G) Resin formulation additive	(G) acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl ester.
P-20-0177	2	09/21/2020	Materia Inc	(G) Resin formulation additive	(G) carbopolycyclic alkenyl, 2-carboxylic acid, 2-[[[4-(4-diarylalkyl)]carbonyl]oxy]ethyl ester.
P-20-0178	2	09/21/2020	Materia Inc	(G) Resin formulation additive	(G) carbopolycyclic alkenyl, 2-carboxylic acid, 2-[[[(diarylalkyl)]carbonyl]oxy]ethyl ester.
P-20-0179	1	09/08/2020	CBI	(S) Reactive polymer for use in surface pre-treatment	(G) 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, branched alkyl diol, and alkyldiol, bis[[[[bis(isocyanatophenoxy)phosphinothioyl]oxy]phenyl]carbamate],
P-20-0179A	2	09/14/2020	CBI	(S) Reactive polymer for use in surface pre-treatment	(G) 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, branched alkyl diol, and alkyldiol, bis[[[[bis(isocyanatophenoxy)phosphinothioyl]oxy]phenyl]carbamate],
P-20-0180	1	09/08/2020	Evonik Degussa Corporation	(S) Curing agent for Industrial epoxy Composite	(S) Cyclohexanemethanamine,5-amino-1,3,3-trimethy-, N-sec-Bu dervis.
P-20-0181	1	09/11/2020	Guardian Industries Corp	(S) Additive to influence melting temperature of raw material and physical characteristics of the final product during the manufacture of flat glass, Animal bedding additive used as a dessicant	(S) flue dust, glass-manugf. desulfurization, calcium hydroxide-treated.
P-20-0182	1	09/15/2020	Eastman Chemical Company, Inc	(G) Plasticizer for PVC formulations	(S) 1,4-Benzenedicarboxylic acid, bis[2-(2-butoxyethoxy)ethyl] ester (9CI).
P-20-0183	1	09/16/2020	CBI	(G) Intermediate	(G) Aryl ether epoxide, homopolymer, ether with alkanolamine.
P-20-0184	1	09/24/2020	P2 Science, Inc	(S) For use in fragrances for consumer products, as well as direct addition to consumer products	(S) 6-Octen-1-ol, 3,7-dimethyl-, homopolymer.
* 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 09/01/2020 to 09/30/2020

Case No.	Received date	Commencement date	If amendment, type of amendment	Chemical substance
J-20-0012	09/18/2020	08/31/2020	N	(G) Biofuel producing saccharomyces cerevisiae modified, genetically stable.
P-14-0787	09/21/2020	08/27/2020	N	(S) Bismuth, 1,1′,1″,1′′′-(1,2-ethanediyldinitrilo)tetrakis[2-propanol] neodecanoate complexes.
P-17-0333	09/15/2020	09/13/2020	N	(G) 2-propenoic acid, mixed esters with heterocyclic dimethanol and heterocyclic methanol.
P-17-0395	09/21/2020	09/16/2020	N	(G) Alkyl tri dithiocarbmate tri salt.
P-18-0329	09/28/2020	09/09/2020	N	(G) Substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer with alkanediol and carbopolycyclic bis (substituted carbopolycycle) bisalkanol.
P-19-0053	08/31/2020	08/26/2020	N	(S) 1-butanamine, n-butyl-n-[(triethoxysilyl)methyl]-.
P-20-0038	09/10/2020	08/21/2020	N	(S) 1,3,5-triazine-2,4,6(1h,3h,5h)-trione, 1,3,5-tris[3-(2-oxiranyl)propyl]-.
P-20-0104	09/16/2020	09/01/2020	N	(G) Alkenoic acid, polymer with (alkyl alkenyl) polyether.
* 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 09/01/2020 to 09/30/2020

Case No.	Received date	Type of test information	Chemical substance
P-16-0370	09/14/2020	Subchronic Inhalation Toxicity 90-Day Study (OECD Test Guideline 413)	(G) Methoxy-terminated polysiloxanes.
P-16-0370	09/14/2020	Subchronic Inhalation Toxicity 90-Day Study (OECD Test Guideline 413)	(G) Polysiloxane with functional groups.
P-16-0543	09/17/2020	Exposure Monitoring Report	(G) Halogenophosphoric acid metal salt.
P-19-0098	09/16/2020	Algal, Growth Inhibiton Test with Pseudokirchneriella subcapitata, 72 hours (OECD Test Guideline 201) and Acute Immobilization Test to Daphnia magna, Semi-static, 48 hours (OECD Test Guideline 202)	(G) Phosphoric acid, polymer with (hydroxyalkyl)-alkanediol and alkanediol.
P-20-0062	09/16/2020	Cobalt Oxide Test Data	(S) Multi-walled carbon nanotubes; closed; 4.4-12.8 nm diameter; bundle length 10.6-211.1 um; grade: Jenotube 6 (substance-1).
P-20-0098	09/22/2020	Eye Irritation Study, Dermal Irritation Study, Acute Oral Toxicity Study, Acute Dermal Toxicity Study, 90-Day Oral Toxicity Study, Ames Test, Chromosomal Aberration Test, Mouse Lymphoma Assay, and Skin Sensitization Test. All test submitted on an analogue	(G) Calcium cycloalkylcarboxylate.
SN-17-0011	09/21/2020	Acute Immobilization Test with Daphnia magna	(G) Polyfluorohydrocarbon.

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: October 7, 2020.

Pamela Myrick,

Director, Information Management Division, Office of Pollution Prevention and Toxics.