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 ingredie nt. This is not a legal document.(E,Z)-7,9-Dodecadien-1-yl acetate Page 2 of 13 Biopesticides Registra tion 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(E,Z)-7,9-Dodecadien-1-yl acetate Page 3 of 13 Biopesticides Registra tion Action Document

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

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

IX. APPENDIX C. References

.................................... ERROR! BOOKMARK NOT DEFINED.(E,Z)-7,9-Dodecadien-1-yl acetate Page 4 of 13 Biopesticides Registra tion 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(E,Z)-7,9-Dodecadien-1-yl acetate Page 5 of 13 Biopesticides Registra tion 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 stra ight-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 pa rts of the world, but, has not previously been observed in the United States. Recently, the E GVM has been observed in the Napa Valley of northern California. It is a specific pest to grapes and can feed on both the fl ower and the fruit of the grapevine. If the moth attacks mature grape cl usters, the berries can become further damaged through infection by the fungus botrytis – a conditi on known as bunch rot. There has already been documented evidence of damage to grapes as cau sed by this pest. In 2009, Napa Valley winegrape growers suffered serious crop loss and damage fr om EGVM. Approximately 30 properties have been officially identified as having the pest presen t, 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 Eur opean 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 e xpedited 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 Poll ution Prevention Division has reviewed the data required to support the registration of this bioc hemical active ingredient, under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Ac t (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 da ta 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 precauti onary labeling of end use products will further minimize potential exposure and mitigate risk to nontarget organisms.(E,Z)-7,9-Dodecadien-1-yl acetate Page 6 of 13 Biopesticides Registra tion 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, whic h 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 phe romone 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(E,Z)-7,9-Dodecadien-1-yl acetate Page 7 of 13 Biopesticides Registra tion Action Document(E,Z)-7,9-Dodecadien-1-yl acetate Page 8 of 13 Biopesticides Registra tion 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), w ith 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-cha ined Lepidopteran Pheromone (SCLP) and is classified as a biochemical pesticide.

B. Food Clearances/Tolerances(E,Z)-7,9-Dodecadien-1-yl acetate Page 9 of 13 Biopesticides Registra tion Action Document

Straight-chained Lepidopteran Pheromones are exempt from the requirement of a tolerance in or on all raw agricultural commodities when applied to gr owing 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 a nd 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 synthe tic 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 s ynthetic 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 id entified 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 s ource dispensers, from which it is released in very small quantities. Restricting the use of the E GVM 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 cons idered 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(E,Z)-7,9-Dodecadien-1-yl acetate Page 10 of 13 Biopesticides Registra tion Action Document

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 associ ated 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(E,Z)-7,9-Dodecadien-1-yl acetate Page 11 of 13 Biopesticides Registra tion 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 w ithout 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 expect ed 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,(E,Z)-7,9-Dodecadien-1-yl acetate Page 12 of 13 Biopesticides Registra tion 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. APHI S 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 peri od 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 ofthis 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 fo r 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 thei r 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.(E,Z)-7,9-Dodecadien-1-yl acetate Page 13 of 13 Biopesticides Registra tion Action Document

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 (inc luding 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.