Certain New Chemicals; Receipt and Status Information

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Federal RegisterNov 24, 2010
75 Fed. Reg. 71688 (Nov. 24, 2010)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

Under sections 5(d)(2) and 5(d)(3) of the Toxic Substances Control Act (TSCA), EPA is required to publish in the Federal Register a notice of receipt of a premanufacture notice (PMN) or an application for a test marketing exemption (TME), and to publish in the Federal Register periodic status reports on the new chemicals under review and the receipt of notices of commencement (NOC) to begin the manufacture of those chemicals. This document covers the period from September 20, 2010, to October 8, 2010, and provides the required notice and status report for the PMNs and TMEs, both pending or expired, and the NOCs to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.

DATES:

Comments must be received on or before December 27, 2010.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2010-0880, and the specific PMN number or TME number for the chemical related to your comment, by one of the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
  • 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: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov,, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov,, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Bernice Mudd, Information Management 7407M, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8951; fax number: (202) 564-8955; e-mail address: mudd.bernice@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitter of the particular PMN or TME addressed in this document. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit CBI to EPA through regulations.gov or e-mail. 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 marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Why is EPA taking this action?

EPA classifies chemical substances as either “existing” chemicals or “new” chemicals. Any substance that is not on EPA's TSCA Chemical Substances Inventory, commonly referred to as the the TSCA Inventory, is classified as a “new chemical,” while those that are on the TSCA Inventory are classified as an “existing chemical.” For more information about the TSCA Inventory go to: http://www.epa.gov/opptintr/newchems/pubs/inventory.htm. Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by section 5 of TSCA to provide EPA with a premanufacture notice, or PMN, before initiating the activity. Section 5(h)(1) authorizes EPA to allow persons, upon application, to manufacture (includes import) or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a), for “test marketing” purposes, which 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(d)(2) and 5(d)(3) of TSCA, EPA is required to publish in the Federal Register a notice of receipt of a PMN or an application for a TME and to publish in the Federal Register periodic status reports on the new chemicals under review and the receipt of the NOCs to begin the manufacture of those chemicals. This document, covers the period from September 20, 2010 to October 8, 2010, and provides the required notice and status report for the PMNs and TMEs, both pending or expired, and the NOCs to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.

III. Receipt and Status Reports

In Table I. of this Unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the PMNs received by EPA during this period: The EPA case number assigned to the PMN, the date the PMN was received by EPA, the projected end date for EPA's review of the PMN, the submitting manufacturer; the potential uses identified by the manufacturer/importer in the PMN, and the chemical identity.

Table I—Premanufacture Notices Received From: 9/21/10 to 10/08/10

P-10-0571
Case No. Received date Projected review end date Manufacturer/ importer Use Chemical
09/21/10 12/19/10 CBI (G) Inhibitor for oil applications (G) Quaternary ammonium compound.
P-10-0572 09/22/10 12/20/10 CBI (S) Coatings for leather; water borne industiral coatings like wood (G) Hexamethylenediisocyanate homopolymer, alkoxy-terminated.
P-10-0573 09/23/10 12/21/10 CBI (G) Polyurethane (open, nondispersive) (G) Thermoplastic polyurethane.
P-10-0574 09/23/10 12/21/10 CBI (G) Additive, open, non-dispersive use (G) Polyisocyanate, reaction product with polyalkylene oxide.
P-10-0575 09/27/10 12/25/10 Eastman Kodak Company (S) Polymer used in manufacture of imaging media/products; for export (G) Methacrylic acid polymer with isoalkylmethacrylamide, arylmethacrylate, and alkenylmethacrylate.
P-10-0576 09/27/10 12/25/10 CBI (S) A surfactant in hard surface cleaning detergent; laundry detergent (G) Alkyloxypropyliminodipropionic acid, monosodium salt.
P-10-0577 09/27/10 12/25/10 CBI (G) Anti-friction coating (G) Polyamideimide.
P-10-0578 09/27/10 12/25/10 CBI (G) Used in industrial coatings (G) Alkylenealkanedioic acid, polymer with alkenylbenzene and alkenenitrile, ammonium salt, alkylhydroperoxide-initiated.
P-10-0579 09/27/10 12/25/10 CBI (S) An isocyanate for adhesives formulations (G) Aromatic isocyanate, polymer with alkoxides and diol.
P-10-0580 09/27/10 12/25/10 CBI (G) Hole injection layer in a polylmeric photovoltaic module (G) Hetromonocyclic[3,4-b]thiophene, homopolymer, 2-[1-[difluoro[(1,2,2-trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2-tetrafluoroethyoxy]-1,1,2,2-tetrafluoroethanesulfonic acid-tetrafluoroethylene polyer-doped.
P-10-0581 09/29/10 12/27/10 CBI (G) Anti-caking agent (S) Iron, isomerized tartarate sodium complexes.
P-10-0582 09/28/10 12/26/10 CBI (G) Moisture curing polyurethane adhesive. The predicted volume for every application is same for all 6 chemical substances. The production is same for all 6 substances (G) Isocyanate terminated urethane polymer.
P-10-0583 09/28/10 12/26/10 CBI (G) Moisture curing polyurethane adhesive. The predicted volume for every application is same for all 6 chemical substances. The production is same for all 6 substances (G) Isocyanate terminated urethane polymer.
P-10-0584 09/28/10 12/26/10 CBI (G) Moisture curing polyurethane adhesive. The predicted volume for every application is same for all 6 chemical substances. The production is same for all 6 substances (G) Isocyanate terminated urethane polymer.
P-10-0585 09/28/10 12/26/10 CBI (G) Moisture curing polyurethane adhesive. The predicted volume for every application is same for all 6 chemical substances. The production is same for all 6 substances (G) Isocyanate terminated urethane polymer.
P-10-0586 09/28/10 12/26/10 CBI (G) Moisture curing polyurethane adhesive. The predicted volume for every application is same for all 6 chemical substances. The production is same for all 6 substances (G) Isocyanate terminated urethane polymer.
P-10-0587 09/28/10 12/26/10 CBI (G) Moisture curing polyurethane adhesive. The predicted volume for every application is same for all 6 chemical substances. The production is same for all 6 substances (G) Isocyanate terminated urethane polymer.
P-10-0588 09/29/10 12/27/10 CBI (S) Precursor to polyimide resin used in aircraft material; precursor to polyimide resin used in electronic and it material (S) Benzenamine, 4,4'-[1,3-phenylenebis(1-methylethylidene)]bis-.
P-10-0589 09/30/10 12/28/10 CBI (G) Plasticizer for resin (G) Dibasic acid ester.
P-10-0590 09/28/10 12/26/10 CBI (G) Component/additive in polymer resins (G) Modified ketal ester.
P-10-0591 09/30/10 12/28/10 CBI (G) Adhesive system component (G) Methylenebis[isocyanatobenzene], polymer with alkanedioic acid, alkylene glycols, alkoxylated alkanepolyol and substituted trialkoxysilane.
P-10-0592 09/28/10 12/26/10 Cytec Industries Inc (G) Coating resin (G) Fatty acids, polymer with substituted carbopolycycle, substuted alkylamines, substituted alkyleneoxide and glycidyl alkanoate, substituted alkanoic acid (salts).
P-10-0593 09/29/10 12/27/10 CBI (G) Adhesive ingredient (G) Modified starch.
P-11-0001 10/01/10 12/29/10 CBI (G) Crosslinking agent for coatings (G) Aromatic polyisocyanate, aliphatic polyol blocked.
P-11-0002 10/01/10 12/29/10 CBI (G) Crosslinking agent for coatings (G) Aromatic polyisocyanate, aliphatic polyol blocked.
P-11-0003 10/01/10 12/29/10 CBI (G) Crosslinking agent for coatings (G) Aromatic polyisocyanate, aliphatic polyol blocked.
P-11-0004 10/01/10 12/29/10 CBI (G) Crosslinking agent for coatings (G) Aromatic polyisocyanate, aliphatic polyol blocked.
P-11-0005 10/01/10 12/29/10 CBI (G) Crosslinking agent for coatings (G) Aromatic polyisocyanate, aliphatic polyol blocked.
P-11-0006 10/01/10 12/29/10 CBI (G) Crosslinking agent for coatings (G) Aromatic polyisocyanate, aliphatic polyol blocked.
P-11-0007 10/01/10 12/29/10 Organic Dyestuffs Corporation (S) Leather dye for distribution; other dyeing applications as needed (S) 2,7-naphthalenedisulfonic acid, 4-amino-6-[[4-[[[4-[(2,4-diaminophenyl)azo]phenyl]amino]sulfonyl]phenyl]azo]-5-hydroxy-3-[(4-nitrophenyl)azo]-, dipotassium salt.
P-11-0008 10/01/10 12/29/10 CBI (G) Component in resins (G) Modified ketal ester.
P-11-0009 10/04/10 01/01/11 Interchem, Inc. (S) Water soluble corrosion inhibitor (G) Alkoxylated imidazoline.
P-11-0010 10/04/10 01/01/11 CBI (S) Resin for coatings, stains, primes and lacquers (G) Fatty acid modified polyester aliphatic polyurethane dispersion.
P-11-0011 10/05/10 01/02/11 Dic International (USA) LLC (G) Adhesive (G) Polyol blocked cycloaliphatic amine polymer.
P-11-0012 10/07/10 01/04/11 CBI (G) A polymer used in a concrete admixture which retains workability by retaining slump in concrete precast applications (G) 2-propenoic acid, 2-methyl-, telomer with 2-propenoic acid and sodium phosphinate (1:1), ester with polyethylene glycol, peroxydisulfuric acid ([ho)s(o)2]2o2)sodium salt (1:2)-initiated.
P-11-0013 10/05/10 01/02/11 Cytec Industries Inc (G) Coatings resin (G) Alkyl dioic acid, polymer with substituted alkanoate, alkyl diisocyanate, alkyldiol, and substituted alkanoic acid.
P-11-0014 10/05/10 01/02/11 Goulston Technologies, Inc (G) Component of lubricant for finish product for fiber and yarn (G) Alkyl amine salt.
P-11-0015 10/06/10 01/03/11 CBI (S) Ingredient for fragrance production (S) Cyclohexanepentanol, -methyl-.

In Table II. of this Unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the TMEs received by EPA during this period: The EPA case number assigned to the TME, the date the TME was received by EPA, the projected end date for EPA's review of the TME, the submitting manufacturer/importer, the potential uses identified by the manufacturer/importer in the TME, and the chemical identity.

Table II—Test Marketing Exemption Notices Received From: 09/21/10 to 10/08/10

T-10-0009
Case No. Received date Projected review end date Manufacturer/importer Use Chemical
09/28/10 11/11/10 Cytec Industries Inc. (G) Coating resin (G) Fatty acids, polymer with substituted carbopolycycle, substituted akylamines, substituted akylneoxide and glycidyl alkenoate, substituted alkanoic acid (salts).
T-11-0001 10/05/10 11/18/10 Cytec Industries Inc. (G) Coating resin (G) Alkyl dioic acid, polymer with substituted alkanoate, alkyl diisocyanate, alkyldiol, and substituted alkanoic acid.

In Table III. 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, the date the NOC was received by EPA, the projected end date for EPA's review of the NOC, and the chemical identity.

Table III—Notices of Commencement From: 9/21/10 to 10/08/10

P-00-0129
Case No. Received date Commencement notice review end date Chemical
10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis-, compound with 2-aminoethanol (1:3).
P-00-0130 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis-, compound with 2-aminoethanol (1:4).
P-00-0131 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt.
P-00-0135 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis-, tetrasodium salt.
P-00-0136 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis-, potassium salt.
P-00-0139 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis-, tripotassium salt.
P-00-0140 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis-, tetrapotassium salt.
P-00-0144 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis-, magnesium salt (1:2).
P-00-0146 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis-, magnesium sodium salt (1:1:2).
P-00-0153 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis- sodium salt, compound with 2-aminoethanol.
P-00-0154 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis- monosodium salt, compound with 2-aminoethanol (1:3).
P-00-0155 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis- disodium salt, compound with 2-aminoethanol (1:2).
P-00-0156 10/01/10 09/07/10 (S) L-aspartic acid, N,N'-1,2-ethanediylbis- trisodium salt, compound with 2-aminoethanol (1:1).
P-07-0353 10/07/10 08/28/10 (G) Alkyl acid fluoride.
P-08-0486 10/05/10 09/17/10 (G) Polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and alkyldiisocyanate, ammonium salt.
P-09-0083 10/04/10 09/03/10 (G) Cationic polyamide.
P-09-0084 09/22/10 09/02/10 (G) Benzenesulfonic acid salt.
P-09-0146 10/01/10 09/28/10 (S) Formaldehyde, polymers with acetone-phenol reaction products and phenol, sodium salts.
P-09-0288 09/22/10 08/21/10 (G) Alkyl silsesquioxanes.
P-09-0430 10/04/10 09/14/10 (G) Polymeric monoazo compound.
P-09-0431 10/04/10 09/14/10 (G) Polymeric monoazo compound.
P-09-0432 10/04/10 09/14/10 (G) Polymeric monoazo triphenylmethane.
P-09-0433 10/04/10 09/14/10 (G) Polymeric triphenylmethane.
P-09-0558 09/27/10 09/10/10 (G) Modified ketal.
P-09-0610 09/22/10 09/01/10 (G) Alkylbenzene sulfonic acid.
P-10-0050 09/29/10 08/30/10 (G) Amine salt.s of fatty acids.
P-10-0128 09/23/10 08/02/10 (S) Siloxanes and silicones, di-me, 3-hydroxypropyl group-terminated, ethoxylated, polymers with 1,6-diisocyanato-2,2,4-trimethylhexane, 1,6-diisocyanato-2,4,4-trimethylhexane, polypropylene glycol ether with glycerol (3:1) and polypropylene glycol ether with pentaerythritol (4:1), polypropylene glycol mono-bu ether-blocked.
P-10-0133 09/29/10 09/21/10 (G) Alkyl sulfide, manuf. of, by-products from, distn. lights.
P-10-0186 09/27/10 09/08/10 (G) Alkyl phosphate salt.
P-10-0293 09/21/10 08/23/10 (G) Methacrylate copolymer.
P-10-0306 09/30/10 08/31/10 (G) Unsaturated polyester resin.
P-10-0325 10/07/10 09/20/10 (G) Neodymium ziegler-natta catalyst.
P-10-0388 10/06/10 08/23/10 (G) 2-propenoic acid, 2-methyl-, polymer with alkyl 2-propenoates, ethenyl acetate and methyl-2-methyl-2-propenoate.
P-10-0389 10/04/10 09/08/10 (G) Amino acid, N-(2-aminoalkyl)-, salt. (1:1), polymers with cycloaliphatic diamine, alkyldiisocyanate, alpha-hydro-omega-hydroxy(alkyldiyl) and polyalkyl glycol mono alkyl ether blocked, alkyldiisocyanate-aromatic diisocyanate, polyalkyl glycol mono alkyl ether blocked.
P-10-0394 10/07/10 09/28/10 (G) Aromatic carboxylic acid.
P-10-0395 10/07/10 10/01/10 (G) Organic carboxylic acid.
P-10-0417 09/22/10 09/21/10 (S) Amines, C36-alkylenedi-, polymers with 5,5'-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione], maleated.
P-10-0430 10/06/10 09/28/10 (G) Urethane acrylate.

If you are interested in information that is not included in these tables, you may contact the person listed under FOR FURTHER INFORMATION CONTACT to access additional non-CBI information that may be available.

List of Subjects

  • Environmental protection
  • Chemicals
  • Hazardous substances
  • Imports
  • Notice of commencement
  • Premanufacturer
  • Reporting and recordkeeping requirements
  • Test marketing exemptions

Dated: November 17, 2010.

Darryl S. Ballaard,

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

[FR Doc. 2010-29674 Filed 11-23-10; 8:45 am]

BILLING CODE 6560-50-P