2018-13944. Certain New Chemical Substances; Receipt and Status Information for March 2018

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 March 1, 2018 to March 31, 2018.

DATES:

Comments identified by the specific case number provided in this document must be received on or before July 30, 2018.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0717, 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 (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 March 1, 2018 to March 31, 2018. 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 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 received 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 received 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 Received From 3/1/2018 to 3/31/2018

Case No.	Version	Received date	Manufacturer	Use	Chemical substance
P-16-0509A	10	3/2/2018	CBI	(G) For packaging application	(G) Modified ethylene-vinyl alcohol copolymer.
P-17-0235A	3	3/28/2018	CBI	(G) Anti-agglomerate	(G) Amidoamino quaternary ammonium salt.
P-17-0288A	7	3/27/2018	SK Chemicals America, Inc	(G) All-purpose packaging	(G) Carbomonocyclicdicarboxylic acid, polymer with cycloalkane(C=5~8) alkanol, alkanediol(C=1~5), 4-(hydroxymethyl)cyclohexyl]methyl 4-(hydroxymethyl)cyclohexanecarboxylate, substitutedalkanol(C=1~5) and 4,4′-[oxybis(methylene)]bis  [cyclohexanemethanol].
P-17-0346A	5	03/19/2018	CBI	(G) Destructive use	(G) Triarylalkyl phosphonium halide salt.
P-17-0398A	5	3/30/2018	Nexus Fuels	(G) Wax-Component of complex formulations for various uses	(G) Branched Cyclic and Linear Hydrocarbons from Plastic Depolymerization.
P-17-0399A	5	3/30/2018	Nexus Fuels	(G) Stock use	(G) Alkane, Alkene, Styrenic Compounds Derived from Plastic Depolymerization.
P-18-0104	2	03/01/2018	CBI	(S) Halogen free flame retardant in thermoplastic polymers	(G) Heteroaromatic substituted alkanoic acid, [2, 2-bis [[(1-oxo-2-propen-1-yl)oxy]methyl]-1,3-propanediyl] ester, dioxide homopolymer.
P-18-0117	2	03/02/2018	Mane USA	(S) Fragrance to be put into a Fine Fragrance, Personal Care Products such as shampoo, body washes and lotions, Consumer Care Products such as laundry detergents, toilet bowl cleaners and air fresheners	(S) Cyclopentaneacetonitrile, 2 , 4 , 4 -trimethyl -a-methylene-.
P-18-0117A	3	03/12/2018	Mane USA	(S) Fragrance to be put into a Fine Fragrance, Personal Care Products such as shampoo, body washes and lotions, Consumer Care Products such as laundry detergents, toilet bowl cleaners and air fresheners	(S) Cyclopentaneacetonitrile, 2 , 4 , 4 -trimethyl -a-methylene-.
P-18-0122	2	03/01/2018	CBI	(G) Paper additive	(G) Alkylamide, polymer with alkylamine, formaldehyde, and polycyanamide, alkyl acid salt.
P-18-0123	1	03/02/2018	Duracell US Operation Inc	(S) Chemical intermediate used in the production of a substance used in battery	(G) Alkali nickel oxide.
P-18-0124	1	03/02/2018	Duracell US Operation Inc	(S) Used in the production of battery electrodes	(G) Alkali nickel oxide.
P-18-0125	1	03/07/2018	Noltex L.L.C	(G) Reagent in coating material	(G) Oxoalkylcarboxylic acid, sodium salt.
P-18-0126	1	03/09/2018	Ishihara Corporation (USA)	(S) Black pigment for architectural paint (e.g. roof and walls of buildings)	(S) Calcium manganese titanium oxide.
P-18-0127	1	03/12/2018	Takasago	(S) Fragrance in fine fragrance (S) Fragrance in household products (laundry detergent), (S) Fragrance in other consumer products, (S) Fragrance in shower gels and shampoos	(S) Heptane, 2-methoxy-2-methyl-.
P-18-0128	1	03/12/2018	Cosun Biobased Products	(G) Surface modifier	(S) Inulin, 2-hydroxy-3-(trimethylammonio)propyl ether, chloride.
P-18-0082A	3	03/12/2018	Cytec Industries Inc	(S) Isolated intermediate used in the manufacture of a surface-active agent	(G) Aspartic acid, tallow modified diester.
P-18-0097A	2	03/12/2018	Mane USA	(S) Maderal is a fragrance that will be added to Personal Care Products, (S) Maderal is a fragrance that will be added to Consumer Care Products, (S) Maderal is a fragrance that will be added to Fine Fragrances	(S) 1,3-Dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethly-.
P-18-0129	1	03/13/2018	CBI	(G) Intermediate used for chemical production	(S) 2,2-dimethyl-3-(3-methylphenyl)propanal,.
P-18-0129A	3	03/20/2018	CBI	(G) Intermediate used for chemical production	(S) Benzenepropanal, alpha, alpha, 3-trimethyl-.
P-18-0116A	2	03/13/2018	CBI	(G) Intermediate for industrial chemical	(G) Fatty acid oil reaction product with fatty acid oil.
P-18-0130	1	03/15/2018	Allnex USA Inc	(S) Adhesion promoter	(G) Substituted alkanediol, polymer with heteromonocycles, alkenoate, metal complexes.
P-18-0130A	3	03/30/2018	Allnex USA Inc	(S) Adhesion promoter	(G) Substituted alkanediol, polymer with heteromonocycles, alkenoate, metal complexes.
P-18-0131	1	03/16/2018	Coim USA Inc	(S) Polyester foam applications	(G) Soybean oil, polymer with mixed difunctional glycols, glycerol, melamine, phthalic anhydride, polyethylene glycol, and terephathalic acid.
P-18-0131A	2	03/27/2018	Coim USA Inc	(S) Polyester foam applications	(G) Soybean oil, polymer with mixed difunctional glycols, glycerol, melamine, phthalic anhydride, polyethylene glycol, and terephathalic acid.
P-18-0132	1	03/20/2018	Cabot Corporation	(S) Pigment dispersing aid	(G) Substituted benzene, 4-methoxy-2-nitro-5-[2-[(1e)-1-[[(2-methoxyphenyl)amino]carbonyl]-2-oxopropylidene]hydrazinyl]-, sodium salt (1:1).
P-18-0133	1	03/20/2018	CBI	(G) Component in hydraulic fracturing fluids	(G) Polyol adduct of bisaldehyde.
P-18-0134	1	03/21/2018	CBI	(G) Used for chemical production	(S) Benzene, 1-(chloromethyl)-3-methyl-.
P-18-0135	3	03/23/2018	CBI	(G) Ingredient for household products	(S) 1,2-decanediol.
P-17-0393A	3	03/22/2018	Allnex USA Inc	(G) Ultra violet (UV) Curable Coating Resin	(G) Alkanediamine, dialkyl-, polymer with a-hydro-w-[(1-oxo-2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) ether with substituted alkyl-substitutedalkanediol, reaction products with alkyl-alkanamine.
P-18-0137	1	03/23/2018	Wacker Chemical Corporation	(S) For improved water protection of construction materials, like cement fiber board	(G) Alkylsilsesquioxane, ethoxy-terminated.
P-18-0138	1	03/26/2018	CBI	(S) Compounding, (S) Injection molding of special applications	(G) Cyclo aromatic dicarboxylic acid, polymer with hexacyclo aromatic dicarboxylic acid, alkanediamine and dicycloalkanediamine.
P-18-0139	1	03/26/2018	Dayglo Color Corp	(G) Pigment for Paint	(G) Rare-earth substituted aluminum strontium oxide, doped.
P-18-0140	2	03/27/2018	AdvanSix Inc	(S) Export, (G) Agricultural solvent, (G) Solvent in coatings	(G) Methyl modified lactam.
P-18-0141	2	03/27/2018	AdvanSix Inc	(G) Solvent in coatings, (S) Export, (G) Agricultural solvent	(G) Ethyl modified lactam.
P-18-0142	1	03/27/2018	Allnex USA Inc	(S) Binder for Topcoat coating	(G) Alkanoic acid, alkyl-, alkyl ester, polymer with substituted alkenoates, alkenoic acid, alkyl peroxoate-initiated.
P-18-0027A	3	03/29/2018	CBI	(G) The polymer will be used as an additive in coatings	(G) 2-Propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl ester, polymer with alpha-(2-alkyl-1-oxo-2-alken-1-yl)-omega-methoxypoly(oxy-1,2-alkanediyl).
P-18-0143	1	03/29/2018	Huntsman International LLC	(S) Customers will further formulate the product containing the PMN substance to make a product that is used in Industrial applications as an anti-corrosive primer coating on metal, (S) Customers will further formulate the product containing the PMN substance to make a product that is used as a primer on concrete	(G) Tofa polymer with amines.
P-18-0144	1	03/29/2018	CBI	(G) Coating	(G) Formaldehyde, polymer with an amine and phenol.
P-18-0145	2	03/30/2018	CBI	(S) Plastic coatings, (S) Parquet coatings, (S) Metal coatings, (S) Wood coatings, (S) Furniture coatings	(G) Dialkanediol, polymer with 5-isocyanato-1-(isocyanatoalkyl)-1,3,3-trialkylcycloalkane, bis[n-[3-(trialkoxysilyl)alkyl]carbamate](ester).
P-18-0028A	2	3/30/2018	Nexus Fuels	(G) Blending stock	(G) Branched cyclic and linear hydrocarbons from plastic depolymerization.

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 received 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 Received From 3/1/2018 to 3/31/2018

Case No.	Received date	Commencement date	If amendment, type of amendment	Chemical substance
P-00-0546A	03/23/2018	08/15/2000	Substantiated CBI	(G) Alkyloxy-hydroxypropyl, trialkylamine, ammonium chloride.
P-12-0084	03/27/2018	02/15/2018		(G) Acrylic modified polyolefin.
P-12-0289	03/13/2018	01/26/2015		(G) Decanedioic acid, polymer with alcohol, isooctadecanoate.
P-12-0351	03/26/2018	03/22/2018		(G) Siloxanes and silicones, alkyl, alkyl propoxy ethyl, methyl octyl, alkyl polyfluorooctyl.
P-16-0278	03/01/2018	02/16/2018		(G) 2-(chloromethyl)oxirane and 4,4'-methylenebis[alkylphenol] polymer with diphenol, reaction products with 2-propenoic acid, 2-methyl-, ethenylbenzene, ethyl 2-propenoate and 2-(dimethylamino)ethanol.
P-16-0370	03/20/2018	02/28/2018		(G) Methoxy-terminated polysiloxane.
P-17-0153	03/19/2018	03/13/2018		(S) D-glucitol,1-deoxy-1-(dimethylamino)-.
P-17-0176	03/22/2018	02/21/2018		(G) Carbonic acid, alkyl carbomonocyclic ester,.
P-17-0283	03/15/2018	02/15/2018		(G) Arenesulfonic acid, alkyl derivatives, metal salts.
P-17-0337	03/06/2018	03/06/2018		(S) Aluminum boron cobalt lithium nickel oxide.
P-17-0338	03/06/2018	03/06/2018		(S) Aluminum boron cobalt lithium magnesium nickel oxide.

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 received by EPA 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 3/1/2018 to 3/31/2018

Case No.	Received date	Type of test information	Chemical substance
J-18-0001	3/6/2018	Data validating microorganism inactivation	(G) Modified Corynebacterium glutamicum.
P-16-0593	3/16/2018	Acute Inhalation Toxicity Study of EP-730 in Rats (OECD 403 and OCSPP 870.1300)	(S) Carboxylic Acids, C6-18 and C5-15-di-, polymers with diethylene glycol, glycerol, sorbitol and terephthalic acid.
P-16-0225	3/19/2018	Direct Peptide Reactivity Assay; KeratinoSens Study Report; DEREK Prediction Report; HRIPT Study Report.	(S) Isomer mixture of Cyclohexanol, 4-ethylidene-2-propoxy- (CAS 1631145-48-6) (35-45%) and Cyclohexanol, 5-ethylidene-2-propoxy (CAS 1631145-49-7) (45-55%).
P-15-0353	3/21/2018	Acute Toxicity to Zebra Fish (Danio rerio) in a 96-hour Screening Test (OECD 203); Acute Toxicity to Daphnia magna in a 48-hour Screening Test(OECD 202); and Anaerobic Biodegradation of Chlorinated Fatty Acid Methyl Esters in Sediment (OECD 311)	(G) Chlorinated Complex Ester.
P-18-0130	3/23/2018	Gel Permeation Chromatography Analysis	(G) Substituted alkanediol, polymer with heteromonocycles, alkenoate, metal complexes.
P-12-0351	3/26/2018	Analytical Report—Impurities	(G) Siloxanes and Silicones, alkyl, alkyl propoxy ethyl, methyl octyl, alkyl polyfluorooctyl.
P-13-0658	3/26/2018	Repeated Dose 90-day Inhalation Toxicity Study in Wistar Rats Dust Aerosol Exposure (OECD 413)	(G) Lithium Metal Phosphate.
P-16-0543	3/27/2018	Exposure Monitoring Report	(G) Halogenophosphoric acid metal salt.
SN-15-0009	3/29/2018	Fish Early Life Stage; Determination of Effects in Sediment on Emergence of the Midge, Chironomus riparius; and Analytical Method Validation in Sediment and Surface Water used in Chironomid Studies	(G) Fatty Acid amide.
P-16-0577	3/29/2018	Two-Generation Reproduction and 90-day Toxicity Study in Rats by Dietary Administration	(G) Alkyl Polyamine.

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: June 19, 2018.

Pamela Myrick,

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