2010-33279. Pesticide Product Registrations; Conditional Approval

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces Agency approval of an application to register the pesticide products Spirotetramat Technical, Movento, BYI 8330 150 OD Insecticide, Ultor, and Spirotetramat 240 SC Greenhouse & Nursery Insecticide/Miticide containing an active ingredient not included in any previously registered products pursuant to the provisions of section 3(c)(7) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. Spirotetramat is a tetramic acid derivative (ketoenole), and is active against sucking insects in vegetables, citrus, pome fruit, stone fruit, grapes, cotton and other plants. It is systemic (xylem and phloem mobile) and can control hidden pests and protect new shoots.

FOR FURTHER INFORMATION CONTACT:

Rita Kumar, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

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 person listed under FOR FURTHER INFORMATION CONTACT.

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

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2010-0130. 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, a copy of the approved labels, the list of data references, the data and other scientific information used to support 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.

A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.

II. Did EPA conditionally approve the application?

A conditional registration may be granted under section 3(c)(7)(C) of FIFRA for a new active ingredient where certain data are lacking, on condition that such data are received by the end of the conditional registration period and do not meet or exceed the risk criteria set forth in 40 CFR 154.7; that use of the pesticide during the conditional registration period will not cause unreasonable adverse effects; and that use of the pesticide is in the public interest. The Agency has considered the available data on the risks associated with the proposed use of spirotetramat, and information on social, economic, and environmental benefits to be derived from such use. Specifically, the Agency has considered the nature and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of spirotetramat during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is in the public interest.

Consistent with section 3(c)(7)(C) of FIFRA, the Agency has determined that these conditional registrations are in the public interest. Use of the pesticides are of significance to the user community, and appropriate labeling, use directions, and other measures have been taken to ensure that use of the pesticides will not result in unreasonable adverse effects to man and the environment.

III. Approved Applications

EPA issued a notice, published in the Federal Register of February 26, 2010 (75 FR 8939) (FRL-8812-8), which announced that Bayer CropScience and Bayer Environmental Science had submitted applications to register the pesticide products, Spirotetramat Technical, Movento, BYI 8330 150 OD Insecticide, Ultor, and Spirotetramat 240 SC Greenhouse & Nursery Insecticide/Miticide, for control of insect pests, (EPA File Symbols 264-RNUO, 264-RNLN, 264-RNLR, 264-RNAL, and 432-RUTR), containing 97.37%, 22.4%, 15.3%, 14.5%, and 22.4% active ingredient respectively. These products were previously registered in 2008, but the registrations were vacated by court order on December 23, 2009, due to lack of publication of a notice of receipt of the registration applications in the Federal Register under section 3(c)(4) of FIFRA. As a result of the vacatur, EPA treated Bayer's earlier-filed applications for registration as then-pending before the Agency.

The applications were conditionally approved on October 15, 2010, as Spirotetramat Technical, Movento, BYI 8330 150 OD Insecticide, Ultor, and Spirotetramat 240 SC Greenhouse & Nursery Insecticide/Miticide (EPA Registration Numbers 264-1049, 264-1050, 264-1051, 264-1065, and 432-1471 respectively) for insect control on citrus, grapes, pome fruit, stone fruit, tree nuts, hops, Christmas tree plantations, vegetables except cucurbits, potato, greenhouses, nurseries, and interiorscapes. The registrations for end-use products were limited to 3 years, expiring on October 15, 2013.

IV. Missing Data

1. Conditional data required for Spirotetramat Technical consists of:

a. Avian Reproduction Study with the Mallard Duck (Anas platyrhynchos) (OPPTS Guideline 850.2300).

b. Immunotoxicity Study (OPPTS Guideline 870.6200).

c. Subchronic Neurotoxicity Study (OPPTS Guideline 870.6200).

d. Full-scale five-batch preliminary analysis of the technical material (OPPTS Guideline 830.1700).

2. Conditional data required for the end-use products consists of:

a. Residue Analysis of Nectar and Pollen in Flowering Citrus (OPPTS Guideline: Special Study).

b. Residue Analysis of Nectar and Pollen in Flowering Tree Crops OPPTS Guideline: Special Study).

V. Response to Comments

EPA issued a notice, published in the Federal Register of February 26, 2010 (75 FR 8939), which announced that Bayer CropScience and Bayer Environmental Science had submitted applications to register the pesticide products, Spirotetramat Technical, Movento, BYI 8330 150 OD Insecticide, Ultor, and Spirotetramat 240 SC Greenhouse & Nursery Insecticide/Miticide. During the public comment period of this notice, comments were received from growers, non-governmental organizations, and the applicant. EPA's response to these comments is posted to the docket EPA-HQ-OPP-2010-0130.

List of Subjects

• Environmental protection
• Chemicals
• Pests and pesticides

Dated: December 23, 2010.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.