2012-6583. Pesticide Product Registration Approvals

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces EPA's issuance, pursuant to the provisions of section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), of certain registrations for new pesticide products and amended registrations for currently existing pesticide products.

FOR FURTHER INFORMATION CONTACT:

A contact person, with telephone number and email address, is listed at the end of each registration and amended registration approval summary. You may also reach each contact person by mail at Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the contact person listed at the end of the registration or amended registration approval summary of interest.

B. How can I get copies of this document and other related Information?

For each registration and amended registration approval summary (see Unit IV. and Unit V.), EPA has established a unique docket identification (ID) number. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov,, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

In accordance with section 3(c)(2) of FIFRA, copies of approved labels, lists of data references, data and other scientific information used to support registration or amended registration, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Such requests should identify the product name and registration number and specify the data or information desired.

Paper copies of the fact sheets, which provide more detail on these registrations and amended registrations, may be obtained from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.

II. EPA's Approval Process

EPA approved the subject applications in accordance with established procedures. EPA considered the nature of the active ingredients, patterns of use, application methods and rates, and levels and extent of potential exposure. EPA has determined that the active ingredients described in Units IV. and V., when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment.

III. Public Participation Process

EPA provides an opportunity to comment on certain registration actions (i.e., new active ingredients, first food uses, first residential uses, first outdoor uses, and other actions of significant interest to the public). Each of the applications described in Units IV. and V. was subjected to a 30-day public comment period (http://www.epa.gov/​pesticides/​regulating/​registration-status.html).

IV. New Active Ingredients

1. Bacillus thuringiensis Cry1Ac Protein and the Genetic Material (Vector PV-GMIR9) Necessary for Its Production in MON 87701 (OECD Unique Identifier: MON 87701-2) Soybean (Bt Cry1Ac). Docket ID Number: EPA-HQ-OPP-2010-0023.

a. Description of New Active Ingredient: Monsanto Company submitted an application to register a pesticide product, MON 87701 (EPA File Symbol 524-LOU), containing the new active ingredient, Bt Cry1Ac.

b. Regulatory Conclusions: On September 9. 2010, EPA registered MON 87701 for use as a seed increase plant-incorporated protectant in soybean (EPA Reg. No. 524-594).

c. Missing Data and Conditions for Submission: None.

d. Response to Comments: EPA received no comments in response to the notice of receipt published on April 14, 2010 (75 FR 19388; FRL-8808-5). One comment was received during the 30-day public participation process occurring immediately prior to the final registration decision. Monsanto Company noted several technical corrections needed to be made to the proposed decision and risk assessment document (i.e., Biopesticides Registration Action Document or “BRAD”) posted for public participation. Monsanto also requested a longer expiration date (five vs. two years) for its registration. In response, EPA updated the BRAD and granted the MON 87701 registration for three years. The revised BRAD is posted to the docket with this notice.

Contact: Mike Mendelsohn, [phone], [e-mail].

2. Bacteriophage of Clavibacter michiganensis subspecies michiganensis (Bacteriophage of Cmm). Docket ID Number: EPA-HQ-OPP-2009-0539.

a. Description of New Active Ingredient: Interregional Research Project Number 4 of Rutgers University, on behalf of OmniLytics, Inc., submitted an application to register a pesticide product, AgriPhage—CMM (EPA File Symbol 67986-A), containing the new active ingredient, bacteriophage of Cmm.

b. Regulatory Conclusions: On September 30, 2011, EPA registered Agriphage—CMM (EPA Reg. No. 67986-6) for field and greenhouse uses on tomato.

c. Missing Data and Conditions for Submission: EPA is requiring submission of data on Analysis of Samples (OCSPP Test Guideline 885.1400) and Storage Stability (OCSPP Test Guideline 830.6317) within one year of registration.

d. Response to Comments: EPA received no comments on this action.

Contact: Denise Greenway, [phone], [e-mail].

3. Chromobacterium subtsugae strain PRAA4-1^T. Docket ID Number: EPA-HQ-OPP-2010-0058.

a. Description of New Active Ingredient: Marrone Bio Innovations, Inc. submitted applications to register two pesticide products, MBI-203 TGAI (EPA File Symbol 84059-O) and MBI-203 EP (EPA File Symbol 84059-RN), containing the new active ingredient, Chromobacterium subtsugae strain PRAA4-1^T.

b. Regulatory Conclusions: On August 26, 2011, EPA registered MBI-203 TGAI (EPA Reg. No. 84059-9) for manufacturing use, and MBI-203 EP Bioinsecticide (EPA Reg. No. 84059-10) for use on agricultural and greenhouse crops, including vegetables, fruit, flowers, bedding plants, ornamentals, and turf.

c. Missing Data and Conditions for Submission: For MBI-203 EP Bioinsecticide (EPA Reg. No. 84059-10), EPA is requiring submission of data on Analysis of Samples (OCSPP Test Guideline 885.1400), Storage Stability (OCSPP Test Guideline 830.6317), and Corrosion Characteristics (OCSPP Test Guideline 830.6320) by September 1, 2012.

d. Response to Comments: EPA received no comments on this action.

Contact: Jeannine Kausch, [phone], [e-mail].

4. 3,7-Dimethyl-2,6-Octadienal (Citral). Docket ID Number: EPA-HQ-OPP-2010-0804.

a. Description of New Active Ingredient: Bedoukian Research, Inc. submitted an application to register a pesticide product, Bedoukian Citral Technical (EPA File Symbol 52991-EA), containing the new active ingredient, Citral.

b. Regulatory Conclusions: On August 23, 2011, EPA registered Bedoukian Citral Technical (EPA Reg. No. 52991-26) for manufacturing use.

c. Missing Data and Conditions for Submission: EPA is requiring submission of data on Storage Stability (OCSPP Test Guideline 830.6317) and Corrosion Characteristics (OCSPP Test Guideline 830.6320) within 12 months of registration.

d. Response to Comments: EPA received no comments on this action.

Contact: Leonard Cole, [phone], [e-mail].

5. (E,Z,Z)-3,8,11-Tetradecatrienyl Acetate. Docket ID Number: EPA-HQ-OPP-2010-0040.

a. Description of New Active Ingredient: ISCA Technologies, Inc. submitted applications to register two pesticide products, ISCA Tuta MP (EPA File Symbol 80286-RT) and SPLAT Tuta^TM (EPA File Symbol 80286-RA), containing the new active ingredient, (E,Z,Z)-3,8,11-Tetradecatrienyl Acetate.

b. Regulatory Conclusions: On September 1, 2010, EPA registered ISCA Tuta MP (EPA Reg. No. 80286-17) for manufacturing use, and SPLAT Tuta^TM (EPA Reg. No. 80286-16) for use on all crops as a mating disrupter for South American tomato leafminer (Tuta absoluta).

c. Missing Data and Conditions for Submission: EPA is requiring submission of data on Storage Stability (OCSPP Test Guideline 830.6317) and Corrosion Characteristics (OCSPP Test Guideline 830.6320) for both products within 1 year of registration.

d. Response to Comments: EPA received no comments on this action.

Contact: Menyon Adams, [phone], [e-mail].

6. (E,Z)-2,13-Octadecadien-1-yl and (E,Z)-2,13-Octadecadien-1-ol. Docket ID Number: EPA-HQ-OPP-2011-0247.

a. Description of New Active Ingredients: Pacific Biocontrol Corporation submitted an application to register a pesticide product, Isomate® DWB (EPA File Symbol 53575-UN), containing the new active ingredients, (E,Z)-2,13-Octadecadien-1-yl and (E,Z)-2,13-Octadecadien-1-ol.

b. Regulatory Conclusions: On August 23, 2011, EPA registered Isomate® DWB (EPA Reg. No. 53575-40) for use on pome fruit, stone fruit, tree nut, and ornamental nursery crops.

c. Missing Data and Conditions for Submission: None.

d. Response to Comments: EPA received no comments on this action.

Contact: Gina Burnett, [phone], [e-mail].

7. Isopropyl Myristate. Docket ID Number: EPA-HQ-OPP-2010-0082.

a. Description of New Active Ingredient: Piedmont Animal Health LLC submitted an application to register a pesticide product, Resultix^TM (EPA File Symbol 86865-R), containing the new active ingredient, Isopropyl Myristate.

b. Regulatory Conclusions: On August 25, 2011, EPA registered Resultix^TM (EPA Reg. No. 86865-1) for treatment of ticks on cats and dogs.

c. Missing Data and Conditions for Submission: None.

d. Response to Comments: EPA received no comments on this action.

Contact: Cheryl Greene, [phone], [e-mail].

8. Oregano Oil. Docket ID Number: EPA-HQ-OPP-2008-0019.

a. Description of New Active Ingredient: Moss Buster LLC submitted an application to register a pesticide product, Moss Buster® (EPA File Symbol 84316-R), containing the new active ingredient, Oregano Oil.

b. Regulatory Conclusions: On March 14, 2011, EPA registered Moss Buster® (EPA Reg. No. 84316-1) to control moss on surfaces (e.g., patios, walls, and rooftops).

c. Missing Data and Conditions for Submission: EPA is requiring submission of data on Storage Stability (OCSPP Test Guideline 830.6317) and Corrosion Characteristics (OCSPP Test Guideline 830.6320) within 1 year of registration.

d. Response to Comments: EPA received no comments on this action.

Contact: Leonard Cole, [phone], [e-mail].

9. Paecilomyces fumosoroseus strain FE 9901. Docket ID Number: EPA-HQ-OPP-2010-0093.

a. Description of New Active Ingredient: Technology Sciences Group, Inc., on behalf of Natural Industries, Inc., submitted applications to register two pesticide products, NoFly^TM WP (EPA File Symbol 73314-A) and NoFly^TM Technical (EPA File Symbol 73314-T), containing the new active ingredient, Paecilomyces fumosoroseus strain FE 9901.

b. Regulatory Conclusions: On May 12, 2011, EPA registered NoFly^TM Technical (EPA Reg. No. 73314-7) for manufacturing use, and NoFly^TM WP (EPA Reg. No. 73314-6) for use on nonfood greenhouse and nursery crops to control whiteflies, aphids, thrips, psyllids, mealybugs, leafhoppers, plant bugs, weevils, grasshoppers, Mormon crickets, locusts, and beetles.

c. Missing Data and Conditions for Submission: EPA is requiring submission of the following data:

i. Analysis of Samples (OCSPP Test Guideline 885.1400), Storage Stability (OCSPP Test Guideline 830.6317), and Corrosion Characteristics (OCSPP Test Guideline 830.6320) for both products within 18 months of registration;

ii. Stability to Normal and Elevated Temperatures, Metals and Metal Ions (OCSPP Test Guideline 830.6313) for NoFly^TM WP within 12 months of registration; and

iii. Additional confirmatory data on the Acute Injection Toxicity/Pathogenicity (Intraperitoneal) study (OCSPP Test Guideline 885.3200) for NoFly^TM Technical within 6 months of registration.

d. Response to Comments: EPA received no comments on this action.

Contact: Kathleen Martin, [phone], [e-mail].

10. Penta-Termanone. Docket ID Number: EPA-HQ-OPP-2009-0333.

a. Description of New Active Ingredient: Bayer Environmental Science submitted an application to register a pesticide product, Penta-Termanone^TM Technical (EPA File Symbol 432-RLNU), containing the new active ingredient, Penta-Termanone.

b. Regulatory Conclusions: On July 15, 2011, EPA registered Penta-Termanone^TM Technical (EPA Reg. No. 432-1504) for manufacturing use.

c. Missing Data and Conditions for Submission: EPA is requiring submission of data on Storage Stability (OCSPP Test Guideline 830.6317) and Corrosion Characteristics (OCSPP Test Guideline 830.6320) within 1 year of registration.

d. Response to Comments: EPA received no comments on this action.

Contact: Menyon Adams, [phone], [e-mail].

11. Pseudomonas fluorescens strain CL145A. Docket ID Number: EPA-HQ-OPP-2011-0568.

a. Description of New Active Ingredient: Marrone Bio Innovations, Inc. submitted applications to register two pesticide products, MOI-401 TGAI (EPA File Symbol 84059-U) and MOI-401 EP (EPA File Symbol 84059-L), containing the new active ingredient, Pseudomonas fluorescens strain CL145A.

b. Regulatory Conclusions: On July 29, 2011, EPA registered MOI-401 TGAI (EPA Reg. No. 84059-4) for manufacturing use, and MOI-401 EP (EPA Reg. No. 84059-5) for use in enclosed static or flowing water infrastructures infested with zebra and/or quagga mussels.

c. Missing Data and Conditions for Submission: EPA is requiring submission of data on Storage Stability (OCSPP Test Guideline 830.6317) for MOI-401 TGAI (EPA Reg. No. 84059-4), and Storage Stability (OCSPP Test Guideline 830.6317) and Corrosion Characteristics (OCSPP Test Guideline 830.6320) for MOI-401 (EPA Reg. No. 84059-5) by January 29, 2012.

d. Response to Comments: EPA received no comments on this action.

Contact: Ann Sibold, [phone], [e-mail].

12. Trichoderma asperellum strain T34. Docket ID Number: EPA-HQ-OPP-2010-0247.

a. Description of New Active Ingredient: Wagner Regulatory Associates, Inc., on behalf of Biocontrol Technologies, S.L., submitted an application to register a pesticide product, T34 Biocontrol (EPA File Symbol 87301-R), containing the new active ingredient, Trichoderma asperellum strain T34.

b. Regulatory Conclusions: On October 20, 2011, EPA registered T34 Biocontrol (EPA Reg. No. 87301-1) for nonfood, greenhouse use.

c. Missing Data and Conditions for Submission: EPA is requiring submission of data on Acute Injection Toxicity/Pathogenicity (OCSPP Test Guideline 885.3200) by October 20, 2012.

d. Response to Comments: EPA received no comments on this action.

Contact: Michael Glikes, [phone], [e-mail].

13. Typhula phacorrhiza strain 94671. Docket ID Number: EPA-HQ-OPP-2010-0090.

a. Description of New Active Ingredient: Technology Sciences Group, Inc., on behalf of Agrium Advanced Technologies RP, Inc., submitted applications to register two pesticide products, Nivalis (EPA File Symbol 84888-E) and Nivalis Technical (EPA File Symbol 84888-R), containing the new active ingredient, Typhula phacorrhiza strain 94671.

b. Regulatory Conclusions: On November 2, 2010, EPA registered Nivalis Technical (EPA Reg. No. 84888-1) for manufacturing use, and Nivalis (EPA Reg. No. 84888-2) for use to control grey snow mold and pink snow mold on golf course turf where continuous snow cover persists for 90 days or longer.

c. Missing Data and Conditions for Submission: EPA is requiring submission of data on Storage Stability (OCSPP Test Guideline 830.6317) and Corrosion Characteristics (OCSPP Test Guideline 830.6320) for both products within one year of registration.

d. Response to Comments: EPA received no comments on this action.

Contact: Denise Greenway, [phone], [e-mail].

V. New Uses for Registered Active Ingredients

1. Cydia pomonella granulovirus (CpGV). Docket ID Number: EPA-HQ-OPP-2010-0059.

a. Description of New Use: Certis USA LLC submitted an application to amend the pesticide product, CYD-X® (EPA Reg. No. 70051-44), containing the active ingredient, CpGV, to allow for new use on apple, pear, plum, prune, and walnut in residential settings.

b. Regulatory Conclusions: EPA approved the requested registration amendment on April 6, 2010 (CYD-X®, EPA Reg. No. 70051-44).

c. Missing Data and Conditions for Submission: None.

d. Response to Comments: EPA received no comments on this action.

Contact: Jeannine Kausch, [phone], [e-mail].

2. Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97. Docket ID Number: EPA-HQ-OPP-2010-0088.

a. Description of New Use: Certis USA LLC submitted applications to amend two pesticide products, PFR-97^TM MUP (EPA Reg. No. 70051-17) and PFR-97^TM 20% WDG (EPA Reg. No. 70051-19), containing the active ingredient, Isaria fumosorosea Apopka strain 97, to allow for new use on all food commodities. These submissions required the concurrent establishment of an exemption from the requirement of a tolerance for residues of Isaria fumosorosea Apopka strain 97.

b. Regulatory Conclusions: EPA approved the requested registration amendments on September 20, 2011 (PFR-97^TM MUP, EPA Reg. No. 70051-17; PFR-97^TM 20% WDG, EPA Reg. No. 70051-19).

c. Missing Data and Conditions for Submission: None.

d. Response to Comments: EPA received no comments on this action.

Contact: Shanaz Bacchus, [phone], [e-mail].

3. Metarhizium anisopliae strain F52. Docket ID Number: EPA-HQ-OPP-2010-0081.

a. Description of New Use: Novozymes Biologicals, Inc. submitted applications to amend three pesticide products: TAE-001 Technical Bioinsecticide (EPA Reg. No. 70127-7), Taenure Granular Bioinsecticide (EPA Reg. No. 70127-8), and TICK-EX EC Bioinsecticide (EPA Reg. No. 70127-10), containing the active ingredient, Metarhizium anisopliae strain F52, for new use on all food commodities. These submissions required the concurrent establishment of an exemption from the requirement of a tolerance for residues of Metarhizium anisopliae strain F52.

b. Regulatory Conclusions: EPA approved the requested registration amendments on April 28, 2011 (TAE-001Technical Bioinsecticide, EPA Reg. No. 70127-7; Taenure Granular Bioinsecticide, EPA Reg. No. 70127-8; TICK-EX EC Bioinsecticide, EPA Reg. No. 70127-10).

c. Missing Data and Conditions for Submission: None.

d. Response to Comments: EPA received no comments on this action.

Contact: Shanaz Bacchus, [phone], [e-mail].

4. Sodium Ferric Ethylenediaminetetraacetate (Sodium Ferric EDTA). Docket ID Number: EPA-HQ-OPP-2010-0182.

a. Description of New Use: Walter G. Talarek, P.C., on behalf of W. Neudorff GmbH KG, submitted applications to register three pesticide products: Ferroxx MP (EPA File Symbol 67702-GR), Slug Exx (EPA File Symbol 67702-GE), and Ferroxx (EPA File Symbol 67702-GG), containing the active ingredient, Sodium Ferric EDTA, to allow for new use on all food commodities. These submissions required the concurrent establishment of an exemption from the requirement of a tolerance for residues of Sodium Ferric EDTA.

b. Regulatory Conclusions: On March 29, 2011, EPA registered Ferroxx MP (EPA Reg. No. 67702-31) for manufacturing use, and Slug Exx (EPA Reg. No. 67702-32) and Ferroxx (EPA Reg. No. 67702-33) for use on all food commodities to control slugs and snails.

c. Missing Data and Conditions for Submission: None.

d. Response to Comments: EPA received no comments on this action.

Contact: Andrew Bryceland, [phone], [e-mail].

List of Subjects

Environmental protection, Chemicals, Pests and pesticides.

Dated: March 8, 2012.

W. Michael McDavit,

Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.