BIOPESTICIDES REGISTRATION ACTION DOCUMENT

(E,Z)-7,9-Dodecadien-1-yl acetate 

PC Code 011471 

EUROPEAN GRAPE VINE MOTH 

U.S. Environmental Protection Agency 

Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

(Last updated February 10, 2010) 

This document is for informational purposes only and is representative of the Agency’s justification in registering 

products containing this active ingredient. This is not a legal document. 
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Biopesticides Registration Action Document

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY:................................................................................................. 5 

II. ACTIVE INGREDIENT OVERVIEW............................................................................... 8 

III. REGULATORY BACKGROUND..................................................................................... 8 

A. Classification ........................................................................................................................ 6

B. Food Clearances and Tolerances........................................................................................ 8 

IV. RISK ASSESSMENT........................................................................................................... 9 

A. Active Ingredient Characterization ................................................................................... 9 

B. Human Health Assessment ................................................................................................. 9 

1. Toxicology.......................................................................................................................... 9 

2. Dose Response Assessment............................................................................................... 9 

3. Food Quality Protection Act (FQPA) Consideration 

...........................................8 

4.. Occupational, Residential, School and Day Care Exposure and Risk 

Characterization ............................................................................................................. 10 

5 Cumulative Effects............................................................................................................ 9

6 Risk Characterization........................................................................................................ 9

C. ENVIRONMENTAL ASSESSMENT.............................................................................. 10 

1. Ecological Hazards.......................................................................................................... 10 

2. Environmental Fate and Ground Water Data ............................................................. 10 

3. Ecological Exposure and Risk Characterization ......................................................... 10 

 4. Endangered Species Assessment................................................................10 

D. EFFICACY DATA............................................................................................................. 11 

V. RISK MANAGEMENT DECISION................................................................................. 11 

A. Determination of Eligibility for Registration.................................................................. 10

B. Regulatory Decision 11 

C. Environmental Justice 13 

VI. ACTIONS REQUIRED BY REGISTRANTS.................................................................. 12 

A. Reporting Adverce Effects ................................................................................................ 13

B. Reporting of Hypersensitivity Incidents.........................................................................................13 
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Biopesticides Registration Action Document

VII. APPENDIX A. Product Specific Information..................................................14

VIII. APPENDIX B. Product Specific Information..................................................15

IX. APPENDIX C. References.................................... ERROR! BOOKMARK NOT DEFINED.
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Biopesticides Registration Action Document

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM 

Office of Pesticide Programs: 

Biopesticides and Pollution Prevention Division 

Biochemical Pesticides Branch (BPB)

Driss Benmhend Biologist / Regulatory Action Leader

Linda Hollis Branch Chief 

Sadaf Shaukat Biologist 
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Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY: 

The new active ingredient (E,Z)-7,9-Dodecadien-1-yl acetate, thereafter referred to as EGVM 

Pheromone, is a technical grade synthetic straight-chained lepidopteran pheromone (SCLP). 

This pheromone is structurally similar to and mimics a naturally occurring pheromone produced 

by the female European grapevine moth (Lobesia botrana), to attract males for mating. The 

active ingredient will mitigate the effects of the EGVM by disrupting the normal mating cycle of 

the EGVM on table and wine grapes. 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. Each twist tie dispenser will be tied, by hand directly on the plant or trellis wires and 

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. 

The European Grape Vine moth (EGVM) Lobesia botrana, 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. It is a specific pest to grapes and 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. There has already been 

documented evidence of damage to grapes as caused by this pest. 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 in Spring 2010. 

In response to an expected infestation of the European Grape Vine Moth in the Napa Valley Area to 

occur in February 2010, the EPA received a request from the U.S. Department of Agriculture’s 

Animal Plant Health Inspection Service for an expedited consideration to register Isomate-EGVM. 

Immediate availability of the product will enable growers to begin to use this product for mating 

disruption efforts immediately when the insects emerge. 

Accordingly, EPA has considered the request for expedited approval of a registration for EGVM 

Pheromone under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act 

(FIFRA) and in doing so, the Biopesticides and Pollution Prevention Division has reviewed the data 

required to support the registration of this biochemical active ingredient, under Section 3(c)(5) of the 

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and has preliminarily evaluated the 

proposed pesticide to assure that its use will not pose unreasonable risks of harm to human health 

and the environment. 

Product chemistry data requirements for both TGAI and EP were satisfied by acceptable 

guideline studies. Toxicology and environmental data requirements for this SCLP TGAI are not 

required per 40 CFR 158.2050(a)(2) and 158.2060(a)(2). No risks to human health are expected 

from the use of lepidopteran pheromones based on the low toxicity in animal testing and the 

expected low exposure to humans. Furthermore, adverse effects on nontarget organisms are not 

expected because pheromones are released in very small quantities in the environment and act on 

a select group of insects. Appropriate precautionary labeling of end use products will further 

minimize potential exposure and mitigate risk to nontarget organisms. 
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Biopesticides Registration Action Document

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for 

the public to participate on major registration decisions before they occur. According to this new 

policy, EPA intends to provide a public comment period prior to making a registration decision 

for, at minimum, the following types of applications: new active ingredients, first food use, first 

outdoor use, and first residential use. 

Consistent with the new policy of making registration actions more transparent, Isomate EGVM 

Pheromone is subject to a 30 day comment period as a “new active ingredient” whose 

registration would result in a “first outdoor use”. While a final decision on registration is 

contingent upon review and consideration of public comments, EPA presently believes that 

based on the preliminary risk assessment and information submitted in support of the registration 

of Isomate EGVM Pheromone that it is in the best interests of the public and the environment to 

issue the registration for Isomate EGVM Pheromone. The basis for this preliminary decision can 

be found in the risk assessment for Isomate EGVM Pheromone, which is characterized in this 

BRAD. 

EPA reviewed data requirements for granting registration under Section 3(c)(5) of the Federal 

Insecticide, Fungicide and Rodenticide Act (FIFRA). It was determined that the 

data/information submitted fulfilled current data requirements (refer to 40 CFR Subpart U § 

158.2000). 

EPA has notified the public that it has received an application to register this pesticide product, 

Isomate-EGVM, a mating disruptor pheromone, which contains an active ingredient not included 

in any previously registered pesticide products. The notice includes a profile of the active 

ingredient and product and a preliminary risk assessment. The Agency has provided opportunity 

for public comment on the application, pursuant to FIFRA Section 3(c)(4). In addition, EPA has 

given advanced notice of the intent to register Isomate-EGVM on an expedited basis. To date, a 

comment that does not support the registration of this active ingredient has been received 

however this comment do not impact the Agency’s preliminary risk assessment of EGVM. EPA 

also had received many (10) requests from several wine grape growers in support of the 

Agency’s preliminary determination to issue registration of this product have been received. All 

comments have been included in the docket (EPA-HQ-OPP-2010-0020). 

Pheromones are natural chemicals emitted by insects that mediate communications between 

individuals of the same species. The EGVM pheromone is one of a group of straight-chain 

lepidopteran pheromones (SCLPs) for which EPA has previously registered many products and 

compiled a substantial database. Based on the Agency’s risk assessment of this class of 

compounds, including the EGVM pheromone, the Agency has preliminarily determined that 

registration of Isomate-EGVM will not cause harm to humans and will not cause unreasonable 

adverse effects on the environments particularly given the fact that the product, when applied, 

volatizes when released. 

Therefore, due to the negligible risk concerns when used as mating disrupter, EGVM Pheromone 

meets the criteria as specified in §3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide 

Act (FIFRA), as amended, and is thus eligible for unconditional registration. It was determined 

that the data/information submitted adequately satisfy applicable data requirements at 40 C.F.R. 

Subpart U §158.2000 
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Biopesticides Registration Action Document

II. ACTIVE INGREDIENT OVERVIEW

Common Name: EGVM Pheromone 

Chemical Names: (E,Z)-7,9-Dodecadien-1-yl Acetate 

Trade & Other Names: EGVM Pheromone 

CAS Registry Number: 

OPP Chemical Code: 011471 

Type of Pesticide: Mating disrupter for European grapevine moth 

Application rates and methods vary depending on the product. For specific information 

regarding the product(s) refer to Appendix B. 

III. REGULATORY BACKGROUND 

On November 16, 2009, Pacific Biocontrol Corporation, submitted an application for the 

registration of the end use product (EP) Isomate® - EGVM, containing 75.68% of the active 

ingredient E,Z)-7,9-Dodecadien-1-yl acetate. A notice of receipt of the application for 

registration of EGVM Pheromone as a new active ingredient was published in the Federal 

Register on February 01, 2010 (75 FR 5077), with a 30-day comment period. To date, a 

comment which do not support the registration of this active ingredient have been received 

however these comments do not impact the Agency’s preliminary risk assessment of EGVM. 

EPA also had received many (10) requests from several wine grape growers in support of the 

Agency’s preliminary determination to issue registration of this product have been received. All 

comments have been included in the docket (EPA-HQ-OPP-2010-0020). 

Consistent with the new policy of making registration actions more transparent, Isomate EGVM 

Pheromone is subject to a 30 day comment period as a “new active ingredient” whose 

registration would result in a “first outdoor use”. While a final decision on registration is 

contingent upon review and consideration of public comments, EPA presently believes that 

based on the preliminary risk assessment and information submitted in support of the registration 

of Isomate EGVM Pheromone that it is in the best interests of the public and the environment to 

issue the registration for Isomate EGVM Pheromone. The basis for this preliminary decision can 

be found in the risk assessment for Isomate EGVM Pheromone, which is characterized in this 

BRAD. 

A. Classification

EGVM Pheromone is a synthetic Straight-chained Lepidopteran Pheromone (SCLP) and is 

classified as a biochemical pesticide. 

B. Food Clearances/Tolerances 
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Biopesticides Registration Action Document

Straight-chained Lepidopteran Pheromones 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/year in accordance with good agricultural practices and indoor post-harvest 

treatment in or on all stored food commodities when applied/used at a rate not to exceed 3.5 grams 

active ingredient (AI)/1,000 square feet/year (equivalent of 150 grams AI/acre/year) in accordance 

with good agricultural practices use practices (40 CFR 180.1153). Pheromones are ubiquitous in the 

environment, and are not considered to be air pollutants. During the season where moths and/or 

butterflies appear, they normally emit pheromones and therefore, humans are naturally breathing in 

the pheromone scent without knowledge and without any adverse reactions. 

IV. RISK ASSESSMENT 

A. Active Ingredient Characterization 

EGVM Pheromone, is a technical grade synthetic straight-chained lepidopteran pheromone 

(SCLP). This pheromone is structurally similar to and mimics a naturally occurring pheromone 

produced by the female European grapevine moth (Lobesia botrana), to attract males for mating. 

B. Human Health Assessment

1. Toxicology Assessment

The active ingredient EGVM Pheromone is a synthetic Straight-chain Lepidopteran Pheromone 

(SCLP). While product chemistry data are required for the registration of a TGAI/ MP for a 

Straight-chain Lepidopteran Pheromone, no toxicology data for the TGAI are required per 40 

CFR 158.2050(a)(2). In light of the Agency’s long history with SCLPs and their relative safety, 

it is expected that future EPs for EGVM Pheromone will demonstrate the same low toxicity as 

observed with all of the SCLPs that have preceded it. 

2. Dose Response Assessment

No meaningful toxicological endpoints were identified on EGVM Pheromone when used as a 

pesticide; therefore, a dose response assessment was not required. 

3. Food Quality Protection Act (FQPA) Consideration 

a. Dietary Exposure and Risk Characterization 

Not required according to 40 CFR 158.2050(a)(2). Moreover, exposure to this pheromone is 

expected to be minimal due to its use in point source dispensers, from which it is released in very 

small quantities. Restricting the use of the EGVM Pheromone to retrievably sized twist ties 

dispensers, will significantly limit the possibility of dietary exposure to the pheromone. Pheromones 

are ubiquitous in the environment, and are not considered to be air pollutants. During the season 

where moths and/or butterflies appear, they normally emit pheromones and therefore, humans are 

naturally breathing in the pheromone scent without knowledge and without any adverse reactions. 

b. Drinking Water Exposure and Risk Characterization
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No significant drinking water exposure or residues are expected to result from the pesticidal 

usage of EGVM Pheromone. The active ingredient is intended for use in retrievable dispensers 

and not to be applied directly to water. If used in accordance with EPA-approved labeling, it is 

not likely to accumulate in drinking water 

As a result, dietary and drinking water exposure to residues of EGVM Pheromone are expected 

to be minimal. 

4. Occupational, Residential, School and Day Care Exposure and Risk Characterization 

EGVM Pheromone is a synthetic compound that is structurally identical to, and mimics, the 

naturally occurring pheromone of the female European grapevine moth, and acts via a non-toxic 

mode of action to specific target pests. The end-use product is not intended for residential uses. 

It will be applied via polymeric-twist ties dispensers placed in trees. The potential for dermal, 

eye, and inhalation exposure to EGVM Pheromone for handlers is minimal and will be mitigated 

as long as products are used according to label directions. The Agency will require labels to 

include the appropriate signal word, re-entry interval, and precautionary statements. 

5. Cumulative Effects

Not applicable to the MP/TGAI (40 CFR 158.2050(a)(2)) 

6. Risk Characterization 

Risk characterizations are not applicable for the MP/TGAI (40 CFR 158.2050(a)(2)). Risk 

characterization depends on the information associated with applications for EGVM Pheromone 

EPs. 

C. ENVIRONMENTAL ASSESSMENT 

1. Ecological Effects and Hazards Assessment 

According to 40 CFR 158.2060 (a) (2), ecological data are not required for SCLPs, when applied 

at a maximum use rate of 150 grams active ingredient/acre/year, and that are not expected to 

available to avian species. EVGM pheromone is structurally similar to and mimics a naturally 

occurring pheromone produced by the female European grapevine moth (Lobesia botrana), to 

attract males for mating. This compound will contained is a twist-tie dispenser that releases less 

than 150 grams active ingredient/acre/year. 

2. Environmental Fate and Ground Water Data 

Environmental fate data are not required for this active ingredient because it is an SCLP 

pheromone applied at a maximum use rate of 150 grams active ingredient/acre/year, and that is 

not expected to available to avian species,. (40 CFR 158.2060) 

3. Ecological Exposure and Risk Characterization
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Biopesticides Registration Action Document

EGVM pheromone is intended for use in polymeric twist-tie dispensers to disrupt the normal 

mating cycle of European grapevine moth on table and wine grapes. As a result, no toxicology 

or environmental fate and effects data were deemed necessary for registration. 

4. Endangered Species Assessment 

Based on the fact that EGVM Pheromone is not toxic to non-target organisms and on its use 

pattern in retrievable dispensers, EPA has determined it will have "No Effect" on any currently 

listed threatened or endangered species or any designated critical habitat 

D. PRODUCT PERFORMANCE DATA (EFFICACY) 

Submission of product performance data (OPPTS 810.3000) is listed as a requirement for all 

pesticide products. Customarily, the Agency requires efficacy data to be submitted for review 

only in connection with the registration of products directly pertaining to the mitigation of 

disease bearing human health organisms and certain designated quarantine pests, i.g., ticks, 

mosquitoes, fleas, Mediterranean fruit flies, gypsy moths, Japanese beetles. For a list of 

organisms considered by the Agency as “public health pests”, please refer to Pesticide 

Registration Notice 2002-1 (http://www.epa.gov/PR_Notices/pr2002-1.pdf). 

V. RISK MANAGEMENT DECISION

A. DETERMINATION OF ELIGIBILITY FOR REGISTRATION 

Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is 

determined that (A) its composition is such as to warrant the proposed claims for it; (B) its 

labeling and other materials required to be submitted comply with the requirements of FIFRA; 

(C) it will perform its intended function without unreasonable adverse effects on the 

environment; and (D) when used in accordance with widespread and commonly recognized 

practice it will not generally cause unreasonable adverse effects on the environment. 

The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied 

by the science assessments evaluating the subject registration application for products containing 

EGVM Pheromone. Such products are not expected to cause unreasonable adverse effects on the 

environment, and are likely to provide protection as claimed when used according to label 

instructions. Therefore, EGVM Pheromone is eligible for registration for the labeled uses. 

B. REGULATORY DECISION 

Based upon our risk assessment for SCLPs, including the EGVM Pheromone, EPA has 

determined 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. Acute toxicity data for EGVM Pheromone demonstrate 

that it is either toxicity category III or IV. EGVM Pheromone does not demonstrate subchronic 

or developmental toxicity, and it is not mutagenic or genotixic. EPA has no concerns for any 

non-target organisms exposed to EGVM Pheromone in accordance with approved label 

directions. EPA has not identified any toxic no meaningful endpoints for non-target mammals, 
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Biopesticides Registration Action Document

birds, plants, aquatic, or soil organisms. Nor are there concerns for any threatened and 

endangered species. 

Thus, given that EGVM Pheromone has very low toxicity and presents little if any risk to nontarget organisms, EPA concludes that it is in the best interests of the public and the environment 

to issue the registration for EGVM Pheromone. Moreover, 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. 

Consistent with the Agency’s new policy for making these registration actions more transparent, 

EPA is providing a 30-day public comment period on the registration of Isomate-EGVM to 

provide a more meaningful opportunity for the public to participate on major registration 

decisions before they occur. To date, a comment that does not support the registration of this 

active ingredient has been received however this comment does not impact the Agency’s 

preliminary risk assessment of EGVM. EPA also had received many (10) requests from several 

wine grape growers in support of the Agency’s preliminary determination to issue registration of 

this product have been received. All comments have been included in the docket (EPA-HQOPP-2010-0020). 

At this time, EPA believes that the data submitted fulfill the requirements of registration for 

products containing Isomate EGVM Pheromone for use as a mating disrupter of European 

grapevine moth on table, wine grapes, using retrievable polymeric dispensers, and at a rate not 

exceeding 150 grams / acre / year. EPA has no concerns for any non-target organisms exposed 

to Isomate EGVM Pheromone in accordance with its approved uses. EPA has not identified any 

meaningful toxic endpoints for non-target mammals, birds, plants, aquatic, or soil organisms; nor 

are there concerns for any threatened and endangered species. Given, the non-toxic character of 

Isomate EGVM Pheromone, EPA supports its registration under Section 3(c)(5) of the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

C. ENVIRONMENTAL JUSTICE 

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of 

all people, regardless of race, color, national origin, or income, in the development, 

implementation, and enforcement of environmental laws, regulations, and policies. To help 

address potential environmental justice issues, the Agency seeks information on any groups or 

segments of the population who, as a result of their location, cultural practices, or other factors, 

may have atypical, unusually high exposure to EGVM Pheromone, compared to the general 

population. Please comment if you are aware of any sub-populations that may have atypical, 

unusually high exposure compared to the general population. 

VI. ACTIONS REQUIRED BY REGISTRANTS

The Agency evaluated all of the data submitted in connection with the initial registration of 

EGVM Pheromone and determined that these data are sufficient to satisfy current registration 

data requirements. No additional data are required to be submitted to the Agency at this time. 

For new uses and/or changes to existing uses, additional data may be required. 
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Not withstanding the information stated in the previous paragraph, it should be clearly 

understood that certain, specific, data are required to be reported to the Agency as a requirement 

for maintaining the Federal registration for a pesticide product. A brief summary of these types 

of data are listed below. 

A. Reporting of Adverse Effects 

Reports of all incidents of adverse effects to the environment must be submitted to the Agency 

under the provisions stated in FIFRA, Section 6(a)(2). 

B. Reporting of Hypersensitivity Incidents 

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

must be reported to the Agency under the provisions of 40 CFR Part 158.2050(d). 

VII. APPENDIX A. DATA REQUIRMENTS (40 CFR Part 158-Subpart U) 

*NOTE: MRID numbers listed in the following tables are representative of supporting data for 

the original registration of the product containing this active ingredient. Subsequent to this 

registration, there may be additional MRIDs that support registration of other products 

containing this active ingredient.