[Federal Register Volume 75, Number 20 (Monday, February 1, 2010)]
[Pages 5077-5079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2146]



[EPA-HQ-OPP-2010-0020; FRL-8808-3]

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 (703) 305-5805.
    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 (703) 305-5805.

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: (703) 308-9525; e-mail 
address: benmhend.driss@epa.gov.


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 

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

[[Page 5078]]

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 
    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

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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.

[FR Doc. 2010-2146 Filed 1-29-10; 8:45 am]