2020-10101. Certain New Chemicals; Receipt and Status Information for March 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 03/01/2020 to 03/31/2020.

DATES:

Comments identified by the specific case number provided in this document must be received on or before June 11, 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, 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, Information Management 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

A. What action is the Agency taking?

This document provides the receipt and status reports for the period from 03/01/2020 to 03/31/2020. 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 03/01/2020 to 03/31/2020

Case no.	Version	Received date	Manufacturer	Use	Chemical substance
P-17-0110A	4	03/12/2020	DIC International (USA) LLC	(G) Masking Photopolymer	(G) Phenol formaldehyde glycidyl ether acrylate cycloalkene ester.
P-17-0233A	4	03/09/2020	CBI	(S) Creping Aid for Yankee Dryers to manufacture tissue and towel paper	(G) Oxyalkylene modified polyalkyl amine alkyl diacid polymer with 2-(chloromethyl)oxirane.
P-17-0414A	6	03/05/2020	CBI	(G) Monitor well performance	(G) Halogenated benzoic acid.
P-18-0059A	2	03/10/2020	Eastman Chemical Company, Inc	(S) Chemical intermediate	(S) Butanoic acid, 4-(dimethylamino)-, ethyl ester.
P-18-0060A	5	03/10/2020	Eastman Chemical Company, Inc	(S) Surfactant for Liquid Dish, Liquid Laundry, and Industrial Hand Wash; Export only volume of the TSCA manufactured NCS; and FDA related uses	(S) 1-Butanaminium, 4-amino-N-(2-hydroxy-3-sulfopropyl)-N, N-dimethyl-4-oxo-, N-coco alkyl derivs., inner salts.
P-18-0069A	3	03/09/2020	Sasol Chemicals (USA) LLC	(G) Polymer performance additive	(G) Surface modified boehmite.
P-18-0143A	7	03/03/2020	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-18-0144A	6	03/03/2020	CBI	(G) Anti-corrosive primer for outdoor industrial applications	(G)Formaldehyde, polymer with an alkane diamine and phenol.
P-18-0152A	6	03/06/2020	CBI	(G) Intermediate for use in manufacturing	(G) Hydrolyzed Functionalized Di-amino Silanol Polymer.
P-18-0152A	7	03/06/2020	CBI	(G) Intermediate for use in manufacturing	(G) Hydrolyzed Functionalized Di-amino Silanol Polymer.
P-18-0152A	8	03/11/2020	CBI	(G) Intermediate for use in manufacturing	(G) Hydrolyzed Functionalized Di-amino Silanol Polymer.
P-18-0237A	9	02/28/2020	CBI	(G) Use in print resins	(G) Alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate-, and dialkylheteromonocycle-blocked.
P-18-0292A	6	02/28/2020	CBI	(G) Use in print resins	(G) alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkylmethacrylate-blocked.
P-18-0323A	7	03/02/2020	Kuraray America, Inc.	(G) Raw material for polymer manufacturing	(S) 2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl ester.
P-18-0326A	7	03/04/2020	CBI	(G) Chemical Intermediate	(G) Alkanoic acid, alkyl ester, manuf. of, byproducts from, distn. residues.
P-18-0330A	2	03/04/2020	CBI	(G) Initiator	(G) Formaldehyde, polymer with alkyl aryl ketone.
P-18-0376A	4	03/11/2020	Sumitomo Chemical Advanced Technologies LLC	(S) Substance used to improve physical properties in rubber products	(G) Thiosulfuric acid, aminoalkyl ester.
P-18-0405A	4	03/05/2020	CBI	(G) Adhesive	(S) Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 3,6,9,12-tetraoxatetradeca-1,13-diene, glycidyl ether.
P-19-0036A	3	03/11/2020	Ethox Chemicals, LLC	(S) As an additive to polymers for improvement in gas barrier performance	(S) 1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) ester.
P-19-0036A	4	03/16/2020	Ethox Chemicals, LLC	(S) As an additive to polymers for improvement in gas barrier performance	(S)1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) ester.
P-19-0077A	11	03/13/2020	CBI	(G) Agricultural	(G) Alkenylamide.
P-19-0116	4	03/24/2020	CBI	(S) Silk protein for production of fiber, and Skincare use as additive in dermal moisturizing lotions	(G)Sr-(WaspSpider Polypeptide-1 Oligopeptide-178).
P-19-0138A	3	03/13/2020	CBI	(G) Intermediate	(G) Perfluorodioxaalkanoyl fluoride.
P-19-0139A	2	03/13/2020	CBI	(G) Intermediate	(G) Perfluoro-2-methyl-trioxaalkanoyl fluoride.
P-19-0140A	3	03/13/2020	CBI	(G) Intermediate	(G)Perfluorodioxaalkyl vinyl ether.
P-19-0160A	2	03/04/2020	CBI	(S) Component of a UV curable printing ink	(G) Alkanesulfonic acid, 2-[(2-aminoethyl)heteroatom-substituted]-, sodium salt (1:1), polymer with alpha-[2,2-bis(hydroxymethyl)butyl]-omega-methoxypoly(oxy-1,2-ethanediyl) and 1,1'-methylenebis[4-isocyanatocyclohexane], acrylic acid-dipenthaerythritol reaction products- and polypropylene glycol ether with pentaerythritol (4:1) triacrylate-blocked.
P-19-0161A	2	03/12/2020	CBI	(S) Organic amine salt mixture used as a foaming agent in the production of urethanes	(G) Alkano1 amine salt mixture.
P-19-0174A	4	03/11/2020	International Lubricants, Inc	(G) Phosphorus antiwear compound	(G) Octadecanoic acid, (alkylphosphinyl), polyol ester.
P-20-0005A	4	03/05/2020	RMC Advanced Technologies, Inc	(G) Additive for plastics and resins	(G) modified graphene.
P-20-0010A	5	03/10/2020	CBI	(G) Polymerization auxiliary	(G) Carboxylic acid, reaction products with metalhydroxide, inorganic dioxide and metal.
P-20-0011A	5	03/04/2020	CBI	(G) Light stabilizer	(G) Tetraoxaspiro[5.5]alkyl-3,9-diylbis(alkyl-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate).
P-20-0022A	3	03/05/2020	CBI	(G) Fuel additive for combustion improver	(G) Polyalkoxycarbopolycycle hydroxy.
P-20-0030A	2	03/13/2020	CBI	(S) Plasticizer for plastisols and in caulks and sealants	(G) Hexanedioic acid, alkyl ester.
P-20-0051A	3	03/11/2020	CBI	(S) Curing agent for Industrial epoxy coating systems	(S) 1,8-Octanediamine, 4-(aminomethyl)-, N-benzyl derivs.
P-20-0061	1	03/03/2020	Allnex USA, Inc	(S) Coating resin crosslinking agent	(G) Formaldehyde, polymer with alkylphenols, alkyl ether.
P-20-0062	1	03/05/2020	Inabata America Corporation	(S) Use as an electrically conductive material, as an additive in field emission applications, as an additive in batteries, energy storage, and electrode applications, as an additive to improve physical or mechanical properties, as an additive for weight reduction, and as a heat generation material	(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-20-0063	1	03/05/2020	Inabata America Corporation	(S) Use as an electrically conductive material, as an additive in field emission applications as an additive in batteries, energy storage, and electrode applications, as an additive to improve physical or mechanical properties, as an additive for weight reduction, as a heat generation material, and as a heat dissipation material	(S) Multi-walled carbon nanotubes; closed; 5.1-11.6 nm diameter; bundle length 1.9-552.0 um; Grade: Jenotube 8 (Substance-2).
P-20-0064	1	03/05/2020	Inabata America Corporation	(S) Use as an electrically conductive material, as an additive in field emission applications, as an additive in batteries, energy storage, and electrode applications, as an additive to improve physical or mechanical properties, as an additive for weight reduction, as a heat generation material, and as a heat dissipation material	(S) Multi-walled carbon nanotubes; closed; 7.9-14.2 nm diameter; bundle length 9.4-106.4 um; Grade: Jenotube 10 (Substance-3).
P-20-0065	1	03/05/2020	Inabata America Corporation	(S) Use as an electrically conductive material, as an additive in field emission applications, as an additive in batteries, energy storage, and electrode applications, as an additive to improve physical or mechanical properties, as an additive for weight reduction, as a heat generation material, and as a heat dissipation material	(S) Multi-walled carbon nanotubes; closed; 17.0-34.7 nm diameters; globular shape; Grade: Jenotube 20 (Substance-4).
P-20-0066	1	03/09/2020	CBI	(G) Antiwear additive for lubricants	(G) 2-Propenoic acid, 2-hydroxyethyl ester, reaction products with dialkyl hydrogen heterosubstituted phosphate and dimethyl phosphonate.
P-20-0067	1	03/11/2020	Shepherd Chemical	(G) Catalyst and Additive	(S) Neodecanoic acid, zinc salt, basic.
P-20-0068	1	03/11/2020	CBI	(G) Perfume	(S) 1,3-Propanediol, 2,2-dimethyl-, 1,3-diacetate.
P-20-0069	2	03/21/2020	CBI	(G) Surface-active chemical	(G) 2-Propenoic acid, 2-methyl-, polymer with 2-hydroxyethyl 2-methyl-2-propenoate phosphate and 2-propenoic acid salt, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)- and sodium (disulfite) (2:1)-initiated.
P-20-0070	1	03/16/2020	Clariant Corporation	(S) Solvent for use in formulated pesticide products, and in agrochemical adjuvant formulations	(S) Nonanamide, N,N-dimethyl-.
P-20-0072	1	03/18/2020	CBI	(G) Additive used to impart specific physicochemical properties to finished articles	(G) Multi-walled carbon nanotubes.
P-20-0074	1	03/23/2020	Clariant Corporation	(S) Surfactant for use in the formulation of pesticide products	(S) Oxirane, 2-methyl-, polymer with oxirane, monoundecyl ether, branched and linear.
P-20-0075	1	03/24/2020	CBI	(G) Pigment dispersant	(G) Phenol, 4,4'-(1-alkylalkylidene)bis-, polymer with 2-(2-aminoalkoxy)alcohol,2- (chloroalkyl)oxirane, N1,N1-dialkyl-1,3-alkanediamine and .alpha-hydro-.omega.-hydroxypoly[ oxy(alkyl-1,2-alkanediyl)], branched 4-alkylphenyl ethers,acetates (salts).
P-20-0076	1	03/25/2020	Cytec Industries, Inc	(G) Mining chemical	(S) Glycine, reaction products with sodium O-iso-Pr carbonodithioate,sodium salts.
SN-19-0006A	3	03/05/2020	CBI	(G) Component for 3D Printing formulations	(S) 2-Propen-1-one, 1-(4-morpholinyl)-.
* 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 03/01/2020 to 03/31/2020

Case No.	Received date	Commencement date	If amendment, type of amendment	Chemical substance
P-13-0123	03/20/2020	03/16/2020	N	(G) Salt of acidic polymers with monomeric and polymeric bases.
P-15-0054A	03/03/2020	09/30/2015	Withdrew CBI claim	(S) Carbon nanotubes (70% single walled and 30% multi-walled (double- or triple-walled) carbon nanotubes.
P-17-0184	03/06/2020	02/11/2020	N	(S) 1-Propanaminium, 2-hydroxy-N,N-dimethyl-N-[3-[(1-oxooctyl)amino]propyl]-3-sulfo-, inner salt.
P-17-0325	03/05/2020	03/05/2020	N	(S) 2-Propenoic Acid, polymer with 2-methyl-2-((1-oxo-2propenyl)amino)-1-propanesulfonic acid.
P-17-0414A	03/09/2020	12/31/2019	Withdrew CBI claim	(S) Benzoic acid, 2,3,5 -trilfuoro.
P-17-0450A	03/09/2020	12/31/2019	Withdrew CBI claim	(S) Benzoic acid, 2,3,4-trichloro-.
P-18-0016	03/13/2020	02/24/2020	N	(G) Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt.
P-18-0172	03/04/2020	11/06/2019	Withdrew CBI claim	(S) Calcium, carbonate 2-ethylhexanoate neodecanoate propionate complex.
P-19-0059	03/02/2020	02/06/2020	N	(S) Butanoic acid, 3-oxo-, 2-[(2-methyl-1-oxo-1-propen-1-yl)oxy]ethyl ester, polymer with butyl 2-propenoate, ethenylbenzene, 1,1′-[(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)]] di-2-propenoate, methyl 2-methyl-2-propenoate and 2-methyl-2-propenoic acid, ammonium salt.
P-19-0099	03/02/2020	02/26/2020	N	(S) Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 1,2-ethanediamine, 2- ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1′-methylenebis[4-isocyanatocyclohexane], compd. with n,n-diethylethanamine.
* 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 03/01/2020 to 03/31/2020

Case No.	Received date	Type of test information	Chemical substance
P-14-0627	03/11/2020	Oral (Gavage) Prenatal Developmental Toxicity Study of n-Butyl Pyrrolidone in New Zealand White Rabbits (OECD Test Guideline 414)	(G) Cyclic amide.
P-14-0627	03/04/2020	Draft: Oral (Gavage) Prenatal Developmental Toxicity Study of n-Butyl Pyrrolidone in New Zealand White Rabbits (OECD Test Guideline 414)	(G) Cyclic amide.
P-16-0404	03/09/2020	Acute Toxicity to the Zebra Fish, Determined Under Static-Renewal Test Conditions (OCSPP Test Guideline 850.1075)	(G) Alkyl ester, 2-({4-[2-(trisubstituted phenyl)azo]-5-acetamido-2-substitutedphenyl} (substituted alkoxy)amino).
P-16-0543	02/28/2020	Exposure Monitoring Report	(G) Halogenophosphoric acid metal salt.
P-18-0303	03/11/2020	Revised Aquatic Toxicity Acute Base set (OECD Test Guideline 201, 202, 203)	(G) 2-propenoic acid, polymer with aliphatic cyclic epoxide.

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: April 21, 2020.

Pamela Myrick,

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