E9-18955. Pesticide Product Registration Approval; Opportunity for Public Comment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces Agency approval of an application to register the pesticide product spirotetramat containing an active ingredient not included in any previously registered products pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, and the opening of a comment period on such approval.

DATES:

Comments must be received on or before September 8, 2009.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2009-0603, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2009-0603. 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 website 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 comment 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, is not placed on the Internet and will be publicly available only in hard copy form. 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 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].

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: kumar.rita @epa.gov.

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, pesticide manufacturer, or interested member of the public. 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. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information 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 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 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. Background

A. FIFRA Registrations

On October 10, 2006, EPA received applications from Bayer CropScience, LLC, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709, to register three new pesticide products containing spirotetramat as an active ingredient under section 3 of FIFRA, 7 U.S.C. 136a, seeking use of spirotetramat on a wide variety of agricultural use sites and on Christmas tree plantations. Spirotetramat is a tetramic acid derivative insecticide. On February 5, 2007, EPA received another application from Bayer Environmental Science for an end-use product for use of spirotetramat for insect control in greenhouses, nurseries, and interior plantscapes and on April 27, 2007, EPA received an application from Bayer CropScience for another end-use product containing spirotetramat for agricultural use.

The applications for the technical and one end-use product were approved on June 30, 2008, as Spirotetramat Technical and Movento (EPA Registration Number 264-1049 and 264-1050, respectively) for control of insects on several agricultural crops and Christmas tree plantations. The application for Spirotetramat 240 SC Greenhouse and Nursery (EPA Registration Number 432-1471) was approved on August 8, 2008, for insect control in greenhouses, nurseries, and interior plantscapes. The application for BYI 8330 150 OD Insecticide (EPA Registration Number 264-1051) was approved on September 24, 2008, for control of insects on several agricultural crops and Christmas tree plantations. The application for Ultor (EPA Registration Number 264-1065) was approved on December 16, 2008, for control of insects on several agricultural crops and Christmas tree plantations.

The Agency approved the applications after considering all required data on risks associated with the proposed use of spirotetramat, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency considered the nature of the chemical 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 when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects to the environment.

B. FFDCA Tolerances

Along with the applications for registration of Spirotetramat Technical, Movento 240 SC Insecticide, and Movento 150 OD Insecticide filed on October 10, 2006, Bayer CropScience also filed a petition under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, to establish tolerances for residues of spirotetramat in or on the raw agricultural commodities: Citrus (Crop Group 10); cucurbit vegetables (Crop Group 9); fruiting vegetables (Crop Group 8); grape (Crop Subgroup 13F); hops; leafy Brassica vegetables (Crop Group 5); leafy non-Brassica vegetables (Crop Group 4); pome fruit (Crop Group 11); potato and other tuberous and corm vegetables (Crop Subgroup 1C); stone fruit (Crop Group 12); tree nuts (Crop Group 14); import tolerances on onions and strawberries; milk; meat, fat; and meat byproducts of cattle, goat, hog, sheep, and horse.

EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), in the Federal Register issue of July 25, 2007 (72 FR 40877) (FRL-8137-1) announcing the filing of this petition. EPA also issued a final rule establishing tolerances for spirotetramat in the Federal Register issue of July 9, 2008 (73 FR 39251) (FRL-8367-1).

III. What Action is the Agency Taking?

Although the Agency solicited comments on the application for a tolerance under FFDCA, it did not do so regarding the applications for registration under FIFRA. Therefore, EPA is now seeking comment on the registrations for the spirotetramat technical and end-use products, issued under section 3 of FIFRA. After consideration of all comments received, the Agency will take appropriate action based on that consideration and issue another Federal Register notice responding to comments received.

List of Subjects

• Environmental protection
• Chemicals
• Pests and pesticides

Dated: July 30, 2009.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.