2010-2146. Pesticide Product; Registration Application

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA has received an application to register a pesticide product containing an active ingredient not included in any previously registered pesticide products. Pursuant to the provisions of section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on this application.

DATES:

Comments must be received on or before March 3, 2010.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2010-0020, 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-2010-0020. 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:

Driss Benmhend, Biopesticides and Pollution Prevention Division (7511P), 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. 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. Registration Applications

EPA received an application as follows to register a pesticide product containing an active ingredient not included in any previously registered products. Pursuant to the provision of section 3(c)(4) of FIFRA, EPA is hereby providing notice of receipt of the application and opportunity to comment.

File Symbol: 53575-GA. Applicant: Pacific Biocontrol Corporation, 575 Viewridge Dr., Angwin, CA 94508. Product name: Isomate-EGVM mating disruptor pheromone (E,Z)-7,9-Dodecadien-1-yl acetate at 75.68%. Proposed classification/Use: None.

III. Background Information

The European Grape Vine moth (EGVM), Lobesia botrana, is a Lepidopteran pest that poses a risk of serious harm to vineyards. The EGVM is established in many parts of the world, but, has not previously been observed in the United States. Recently, the EGVM has been observed in the Napa Valley of northern California. The EGVM can feed on both the flower and the fruit of the grapevine. If the moth attacks mature grape clusters, the berries can become further damaged through infection by the fungus botrytis - a condition known as bunch rot. In 2009, Napa Valley winegrape growers suffered serious crop loss and damage from EGVM. Approximately 30 properties have been officially identified as having the pest present, and it is believed that the pest will be found on many more properties once delimitation trapping is conducted this spring. As a sustainable agriculture community, registration of a pheromone-based product is of importance to the Napa Valley winegrape growers and other affected communities in order to provide effective, sustainable, and low risk alternatives to traditional pesticides.

The subject active ingredient is a synthetic biochemical that is structurally similar to and mimics the naturally occurring pheromone produced by the female EGVM to attract males for mating. This pheromone is one of a group of straight-chain lepidopteran pheromones (SCLPs) for which EPA has previously conducted an aggregate risk assessments. The active ingredient will mitigate the effects of the EGVM by disrupting the normal mating cycle of the EGVM. The pheromone will be contained in a twist-tie dispenser that consists of a polyethylene plastic tube parallel to an associated aluminum wire within the field. It will be applied by hand directly on the plant or trellis wires. Each twist-tie dispenser slowly releases infinitesimal amounts of pheromone into the atmosphere. The pheromone slowly diffuses from the inside of the tube to the surface where it volatilizes in microgram amounts. This formulation is not randomly distributed by a mechanical device, nor is it sprayed into the air.

A. What are pheromones?

Pheromones are natural chemicals emitted by insects that mediate communications between individuals of the same species. Pheromones serve a number of functions including identifying the location of food sources, alarming other individuals about potential dangers, and locating potential mates. Pheromones are ubiquitous in the environment, and are not considered to be air pollutants.

EPA has registered many products containing SCLPs. The Agency has compiled a substantial database on SCLPs and has assessed the risks of this class of compounds to human health and the environment. SCLPs exhibit negligible toxicity in animal testing; have no effects on non-target species; and are used at extremely low rates (application rates of SCLPs do not exceed 150 grams active ingredient/acre/year). Because the effects of SCLPs are highly species specific, and given their low application rates, risks to human health are negligible. In addition, EPA concludes that there is no likelihood of adverse effects to non-target organisms. SCLPs are exempt from the requirement of a tolerance in or on all raw agricultural commodities when applied to growing crops at a rate not to exceed 150 grams of active ingredient/acre (40 CFR 180.1153). EPA has determined that there is a certainty of no harm from consumption of food containing residues of SCLPs.

B. What is Isomate-EGVM?

The application before the Agency is for “Isomate-EGVM,” an end-use product (EP) containing 94% of active ingredient, which is the SCLP that is chemically similar to the pheromone produced naturally by the European Grapevine Moth - and which has a similar physiologic effect. In general, pheromones are easily broken down by UV light and oxidation, and do not remain long in the environment. But, to be effective, the Isomate-EGVM must last long enough to effectively act on the target pest's population within the orchards where they are used. Inert ingredients are therefore added as stabilizers to protect the longevity of the pheromone. Isomate-EGVM contains two inert ingredients, BHT and bumetrizole. BHT is an antioxidant and bumetrizole functions as a UV stabilizer. BHT is approved by the FDA as a food additive permitted for direct addition to food for human consumption, and is present in a wide array of food items. Bumetrizole is also approved by the FDA as a stabilizer in polymers used in producing, manufacturing, packaging, processing, and transporting food. In addition, the NOP (National Organic Program) has approved both of these ingredients for organic uses involving twist-tie dispensers.

C. EPA’s Proposed Action

Pursuant to FIFRA Section 3(c)(4), EPA is providing notice of, and the opportunity to comment on, the receipt of an application for registration for the pesticide product Isomate-EGVM. In addition, EPA is providing advanced notice of OPP's preliminary risk assessment on Isomate-EGVM. EPA has been informed by USDA’s Animal Plant Health Inspection Service (APHIS) that vineyards located in Sonoma and Napa counties in California have become infested with EGVM. The moth is currently in diapause. APHIS is concerned that an active and severe infestation may begin when the moths begins to emerge from diapause in late February. APHIS has requested expedited consideration of the Isomate-EGVM registration application so that growers will be able to immediately begin to use this product for mating disruption efforts when the insects emerge. Based upon EPA's risk assessment for SCLPs, including the EGVM pheromone, EPA believes that registration of Isomate-EGVM will not cause harm to humans and will not cause unreasonable adverse effects on the environment particularly given the fact that the product, when applied, volatizes when released.

List of Subjects

• Environmental protection
• Pesticides and pest

Dated: January 21, 2010.

Keith Matthews,

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