Certain New Chemical Substances; Receipt and Status Information for May 2018

Federal RegisterAug 14, 2018

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0404; FRL-9981-43]

Certain New Chemical Substances; Receipt and Status Information for May 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 May 1, 2018 to May 31, 2018.

DATES:

Comments identified by the specific case number provided in this document must be received on or before September 13, 2018.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0404, 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: (202) 564-8593; email address:

rahai.jim@epa.gov.

For general information contact:

The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address:

TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

This document provides the receipt and status reports for the period from May 1, 2018 to May 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?

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.

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 5/1/2018 to 5/31/2018

Case No.

Version

Received date

Manufacturer

Use

Chemical substance

P-18-0057

5/1/2018

CBI

(S) A drier accelerator that is used for superior drying performance in solvent-borne and waterborne air dried paints, inks and coatings

(S) Vanadium, tris(2-ethylhexanoato-ko)tri-μ-oxotri-, cyclo.

P-18-0162

5/8/2018

CBI

(G) Adhesive component

(G) Cashew nutshell liquid, polymer with diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol.

P-18-0162A

5/16/2018

CBI

(G) Adhesive component

(G) Cashew nutshell liquid, polymer with diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol.

P-18-0163

5/7/2018

Cabot Corporation

(S) Pigment Dispersing Aid

(G) Substituted, (4-amino-l-hydroxybutylidene)bis-, sodium salt (1:1), reaction products with epichlorohydrin-trimethylolpropane polymer and maleic anhydride-styrene polymer, sodium salts.

P-18-0164

5/7/2018

CBI

(S) Pigment Dispersing Aid

(G) Substituted, (4-amino-1-hydroxybutylidene)bis-, sodium salt (1:1), reaction products with 2-[2-[3-(aminomethyl)phenyl]diazenyl]-n-(substitutedphenyl)-3-oxobutanamide, epichlorohydrin-trimethylolpropane polymer and maleic anhydride-styrene polymer, sodium salts.

P-18-0167

5/7/2018

Cabot Corporation

(S) Chemical intermediate

(G) Butanamide, 2-[2-[(substitutued phenyl)diazenyl]-n-(2-methoxyphenyl)-3-oxo-.

P-18-0168

5/4/2018

CBI

(G) color additive

(G) Alkoxylated triaryl methane.

P-18-0169

5/7/2018

C. L. Hauthaway & Sons Corp

(G) Protective coating

(G) Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 1,6-hexanediol, diamine and 1,1′-methylenebis[4-isocyanatocyclohexane], acrylate-blocked, compds. with triethylamine.

P-18-0169A

5/15/2018

C. L. Hauthaway & Sons Corp

(G) Protective coating

P-18-0170

5/10/2018

CBI

(G) Textile treatment

(S) 1-propanaminium, n,n′-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-n,n-dimethyl-, dichloride.

P-18-0170A

5/23/2018

CBI

(G) Textile treatment

(S) 1-propanaminium, n,n′-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-n,n-dimethyl-, dichloride.

P-18-0171

5/4/2018

CBI

(G) Industrial Inks and coatings

(G) Dialkylamine, reaction products with polyalkylene glycol ether with alkylolalkane acrylate.

P-18-0172

5/10/2018

CBI

(S) By function and application i.e. a dispersive dye for finishing polyester fibers) Calcium is an auxiliary drier that is used solely in combination with primary and secondary driers. It can also be used as a pigment wetting agent and loss of dry additive. Calcium itself has no drying effect on binders that dry by oxidation. However, it yields synergistic effects in combination with primary driers such as cobalt, manganese and Borchi OXY-Coat, and with secondary driers such as zirconium. When added during the dispersion, it prevents adsorption of the primary driers by the pigments thereby stabilizing surface dry. Calcium also promotes pigment wetting to improve film gloss. Applications 10% Calcium Cem-All® driers are based on a blend of carboxylate metal salts and are designed for Solventborne coatings only. Calcium driers are used in all oxidatively cured systems, whether air or force dried. They are used in architectural paints, industrial coatings and stains. Dosage In conventional alkyd formulations, the Calcium addition is between 0.03-0.30% metal based on the vehicle solids of the coating and will vary depending upon the composition of the binder. The specific drier blend should be experimentally determined. Higher levels might be needed if added to the dispersion to prevent drier adsorption. Calcium drier can be added to the dispersion and/or in the letdown with other driers

(S) Calcium, carbonate 2-ethylhexanoate neodecanoate propionate complex.

P-18-0172A

5/15/2018

CBI

(S) Calcium, carbonate 2-ethylhexanoate neodecanoate propionate complex.

P-18-0172A

5/21/18

CBI

(S) Calcium, carbonate 2-ethylhexanoate neodecanoate propionate complex.

P-18-0173

5/8/2018

CBI

(S) Thicker for consumer coatings

(G) Poly (oxy1,2-alkydiyl) hydroxy polymer with cyanoato butylalcohol.

P-18-0174

5/9/2018

CBI

(G) Oilfield applications

(G) Enzyme.

P-18-0175

5/11/2018

Hexion Inc

(S) Food can coating, Non-food contact can coating

(S) Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol and phenol, bu ether.

P-18-0176

5/17/2018

CBI

(G) Open, non-dispersive use

(G) 5-isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, polymer with aminoalcohol, 2,2-dimethyl-1,3-propanediol, 2,5-furandione, polyalkylene glycol and unsaturated anhydride.

P-18-0177

5/15/2018

Clariant Plastics & Coatings USA Inc

(S) Lubricant and surface protection agent, Coating and treatment agent for use in agricultural applications

(S) Waxes and waxy substances, rice bran, oxidized.

P-18-0178

5/22/2018

Galata Chemicals LLC

(S) Stabilizer for PVC

(G) Dialkyltin dialkylcarboxylate.

P-18-0179

5/16/2018

CBI

(G) Adhesive

(G) Phenol, polymer with formaldehyde and phenolic resin, sodium salt.

P-18-0180

5/16/2018

CBI

(G) Adhesive

(G) Phenol, polymer with formaldehyde and phenolic resin, potassium salt.

P-18-0181

5/16/2018

CBI

(G) Adhesive

(G) Phenol, polymer with formaldehyde and phenolic resin, potassium sodium salt.

P-18-0183

5/14/2018

CBI

(S) Curing agent for epoxy coating systems

(G) Benzaldehyde, reaction products with polyalkylenepolyamines, hydrogenated, reaction products with me et ketone.

P-18-0184

5/21/2018

Eastman Kodak Company

(G) Component in printing plates, Coating component

(G) Halide, bis alkylaromatic, polyaromatic non-metal salt.

P-18-0185

5/21/2018

Allnex USA Inc

(S) Adhesion-enhancing resin for wood applications.

(G) Fatty acid, polymer with alkanedioic acid dialkyl ester, hydroxyl alkyl substituted alkanediol, substituted carbomonocycle and alkylol substituted alkane.

P-18-0186

5/22/2018

CBI

(G) Fuel additive—destructive use

(G) Polyolefin ester.

P-18-0188

5/23/2018

Allnex USA Inc

(S) Adhesion and scratch resistance

(G) Alkyl substituted alkenoic acid, alkyl ester, polymer with alkanediol alkyl-alkenoate, reaction products with alkenoic acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle and substituted alkanediol.

P-18-0189

5/24/2018

Everris NA Inc

(S) Inorganic Fertilizer

(S) Phosphoric acid, potassium salt (2:3), dihydrate (9Cl).

P-18-0192

5/29/2018

Archroma U.S., Inc

(S) Optical brightener for use in paper applications.

(G) Benzenesulfonic acid, (alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2-yl]amino]-, n-(hydroxyalkyl) derivs., salts, compds. with polyalkyl-substituted(alkanol).

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 5/1/2018 to 5/31/2018

Case No.

Received date

Commencement date

If amendment, type of amendment

Chemical substance

J-17-0018

5/1/2018

4/29/2018

(S) Genetically engineered yeast FS-0130.

P-13-0253

5/24/2018

5/18/2018

(G) Tritylated ether.

P-14-0597

5/1/2018

4/27/2018

(G) Neodecanoic acid, compd. with alkyldiamine.

P-15-0442

5/24/2018

10/12/1995