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 March 5, 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 .............................................................................. 7 

III. REGULATORY BACKGROUND..................................................................................... 7 

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

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

IV. RISK ASSESSMENT........................................................................................................... 8 

A. Active Ingredient Characterization.................................................................................... 8 

B. Human Health Assessment.................................................................................................. 8 

1. Toxicology.......................................................................................................................... 8 

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 ............................................................. 11 

3. Ecological Exposure and Risk Characterization ......................................................... 11 

 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.................................................................. 13 

A. Reporting Adverse Effects ................................................................................................ 13

B. Reporting of Hypersensitivity Incidents.........................................................................................13 
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VII. APPENDIX A. Product Specific Information..................................................14
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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: 

This Biopesticides Registration Action Document (BRAD) presents EPA's risk assessment and 

regulatory decision on the new biochemical pesticide active ingredient (E,Z)-7,9-Dodecadien-1-

yl acetate. (E,Z)-7,9-Dodecadien-1-yl acetate is a technical grade synthetic straight-chained 

lepidopteran pheromone (SCLP) that is structurally similar to and mimics the naturally occurring 

pheromone produced by the female European Grapevine moth (Lobesia botrana) (EGVM) to 

attract males for mating. The synthetic active ingredient (Isomate-EGVM) is intended to 

mitigate the effects of the EGVM by disrupting the normal mating cycle of the EGVM in 

vineyards. Isomate-EGVM will be contained in a twist-tie dispenser that consists of a 

polyethylene plastic tube parallel to an associated aluminum wire. The pheromone slowly 

diffuses from the inside of the tube to the surface where it volatilizes in microgram amounts. 

Each twist tie dispenser will be tied directly on the plant or trellis wires, and will slowly release 

infinitesimal amounts of pheromone into the atmosphere. This formulation is not randomly 

distributed by a mechanical device, nor is it sprayed into the air. 

The EGVM feeds on both the flower and the fruit of the grapevine, and poses a risk of serious 

harm to vineyards. If the moth attacks mature grape clusters, the berries can become further 

damaged through infection by the fungus botrytis cine rea – a condition known as bunch rot. 

While the EGVM is established in many parts of the world, it has not previously been observed 

in the United States. But, 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 the spring of 2010. 

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

anticipated to occur during the 2010 growing season, the EPA received a request from the U.S. 

Department of Agriculture’s Animal Plant Health Inspection Service (APHIS) for expedited 

consideration of the registration application for Isomate-EGVM. APHIS requested expedited 

consideration of the registration application so that the product would be available for mating 

disruption efforts immediately during the time the insects emerge from diapause. 

EPA has considered the Isomate-EGVM registration application on an expedited basis and has 

determined to grant a registration for Isomate-EGVM under Section 3(c)(5) of the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA has determined that registration and 

use of this pesticide in accordance with label directions will not cause unreasonable adverse 

effects to the environment. In addition, EPA has determined that there is a reasonable certainty 

of no harm from dietary exposure to residues of Isomate-EGVM. 

Product chemistry data requirements for both the technical grade active ingredient (TGAI) and 

the end-use product (EP) were satisfied by acceptable guideline studies. EPA's regulations at 40 

CFR 158.2050(a)(2) and 158.2060(a)(2) exempt straight chain lepidopteran pheromones from 

human health, non-target organism, and environmental fate data requirements. EPA has 

concluded that use of SCLPs in accordance with approved labels does not pose a risk to human 

health based on the low toxicity in animal testing and the expected low exposure to humans. 

Thus, given that these compounds present both low hazard and low exposure, we have 

determined that, when used as directed, they present low risk to both humans and non-target 

organisms (and, in actuality, they present low toxicological risk to the target organism). 
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Pursuant to FIFRA Section 3(c)(4), EPA provided notice of receipt of an application to register 

the biochemical pesticide Isomate-EGVM, which contains an active ingredient not included in 

any previously registered pesticide products, and opportunity for comment. The notice included 

a profile of the product and the active ingredient, and a preliminary risk assessment. In addition, 

given the urgent circumstances of a potential EGVM infestation, and the need to begin mating 

disruption efforts as soon as possible after insect emergence, EPA noted its intent to register 

Isomate-EGVM – provided no contrary information was received during the comment period. 

During that 30-day comment period, EPA did not receive any substantive comments that 

provided data or information calling into question EPA's risk assessment. EPA received 12 

comments in support of registration of Isomate-EGVM as soon as possible. All comments have 

been included in the docket. 

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

the public to comment on significant registration decisions prior to the Agency's final decision. 

According to this new policy, EPA intends to provide a public comment period in advance of 

making a registration decision for, at minimum, the following types of applications: new active 

ingredients, first food use, first outdoor use, first residential use, and any registration action for 

which the Agency believes there may be substantial public interest. 

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 without delay. Consistent with the 

Agency’s new policy for making these registration actions more transparent, however, EPA is 

issuing this registration with an initial period of one-year and, concurrent with its issuance, 

providing a 30-day public comment period on the time-limited registration. EPA is registering 

this product as a time-limited registration, with the understanding that public comments could 

bring to light new information or concerns that could inform EPA’s initial decision. Therefore, 

EPA is granting a time-limited one year registration for Isomate-EGVM. 
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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. In addition to 

providing notice of receipt of the application, the notice included a profile of the product and the 

active ingredient, a preliminary risk assessment, a description of the urgent circumstances of a 

potential EGVM infestation and the need to begin mating disruption efforts as soon as possible 

after insect emergence, and EPA's inclination to register Isomate-EGVM – provided no contrary 

information was received during the comment period. EPA received a total of thirteen 

comments on the notice of receipt. Twelve comments supported immediate registration of 

Isomate-EGVM. One comment opposed the registration of Isomate-EGVM, but did not provide 

any substantive basis supporting that position. That comment also did not provide any data or 

information calling into question EPA's risk assessment. All comments have been included in 

the docket. 

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 without delay. Consistent with the 

Agency’s new policy for making these registration actions more transparent, however, EPA is 

issuing this registration with an initial period of one-year and, concurrent with its issuance, 

providing a 30-day public comment period on the time-limited registration. EPA is registering 

this product as a time-limited registration, with the understanding that public comments could 

bring to light new information or concerns that could inform EPA’s initial decision. Therefore, 

EPA is granting a time-limited one year registration for Isomate-EGVM. 

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

classified as a biochemical pesticide. 

B. Food Clearances/Tolerances 

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 exposed to 

numerous pheromones without 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. 

 The descriptions of the product formulation and production process, as well as the formation of 

impurities, were examined by the Agency and found to meet current standards. The production 

process was adequately described. The packaging was also adequately described and quality 

control/quality assurance procedures were discussed. The formation of potential impurities in the 

product was adequately described. Acceptable results were provided regarding the preliminary 

analysis of five batches of the product. The physical/chemical characteristics were adequately 

presented. In addition, the applicant submitted acceptable updated storage stability data that 

included values at the 6 month interval.

B. Human Health Assessment

1. Toxicology Assessment

Isomate-EGVM has a low application rate (not to exceed 150 grams active ingredient/acre/year) 

and expected exposure to humans is low. Adequate information and data waiver rationales to 

address all toxicity requirements for this product was submitted by the applicant. The product 

consists of two polymer tubes, one filled with a wire, and the other filled with the pheromone 

formulation. This twist-tie dispenser precludes concerns for toxicity via the dermal, ocular, oral, 

and inhalation routes of exposure. Label requirements indicate that the product must be applied 

while wearing chemical resistant gloves and protective eyewear. In addition, with no direct 

contact with food or feed crops, there is no chance to develop skin sensitization through the oral 

route and inhalation exposure is negligible. Also, the inerts in this product are all cleared for 

food-use and SCLP’s are exempt from the requirement of a tolerance. In summary, no risk to 

human health is expected from the use of Isomate-EGVM. 
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2. Dose Response Assessment 

Isomate-EGVM contains 191.79 mg of (E,Z)-7,9-Dodecadien-1-yl acetate. Given the maximum 

label use-rate of no more than 200 twist ties per application, the calculated grams of active 

ingredient (AI) per acre of application equals 38.358 g. 782 twist ties per acre may be used for 

the entire calendar year. Assuming a worst case misuse scenario of 782 dispensers used in a 

single application, this would result in an emission of 149.798 g AI/acre/year. Assuming a yearround application of 782 twist ties per acre, an approximated daily application rate would be 410 

mg AI/acre/day. Comparing this to typical natural exposure, codling moths during the calling 

period are estimated to release an approximate 240 ng pheromone/hr,* resulting in total 

pheromone release of 6-2184mg pheromone/acre/day. Thus, worst case year-round application 

of Isomate-EGVM via twist ties would be in the lower range of natural release by a living 

lepidopteran. Thus, given that expected emissions of (E,Z)-7,9-Dodecadien-1-yl acetate in 

Isomate-EGVM is comparable to naturally occurring emissions of pheromones during an 

infestation, we conclude that it will have no impact on human health, non-target organisms, or 

the environment. 

3. Food Quality Protection Act (FQPA) Consideration 

a. Dietary Exposure and Risk Characterization 

In accordance with 40 CFR 180.1153, SCLPs such as Isomate-EGVM are exempt from the 

requirement of a tolerance. Moreover, notwithstanding this exemption, exposure to this 

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

released in infinitesimal 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. As discussed above regarding the human health assessment, Isomate-EGVM poses 

negligible toxicological hazard, including dietary hazard. Therefore, given the negligible dietary 

hazard and the limited possibility of dietary exposure, we conclude that there will be very low 

risk associated with dietary exposure to Isomate-EGVM. 

We note that this is consistent with the determination of the OECD, which has determined that 

consumption of food containing residues of SCLPs presents no risk (OECD- Guidance for 

Registration Requirements for Pheromones and Other Semiochemicals Used for Pest Control 

(http://www.epa.gov/pesticides/biopesticides/regtools/index.htm). 

b. Drinking Water Exposure and Risk Characterization

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. 

 

* OECD Series on Pesticides No. 12: Guidance for Registration Requirements for Pheromones and 

Other Semiochemicals Used for Arthropod Pest Control, dated 02/26/2002 (citing data from EPA's Pheromone White Paper, by J. 

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

 a. Occupational Exposure and Risk Characterization 

As discussed above, Isomate-EGVM acts via a non-toxic mode of action to target specific pests. 

Low oral, dermal, and inhalation toxicity have been demonstrated by the data summarized above. 

 The end-use product will be applied via polymeric-twist tie dispensers placed in trees. As 

discussed above, 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. 

 b. Residential, School, and Day Care Exposure and Risk Characterization 

No indoor residential, school, or day care uses are currently approved for products containing 

EGVM Pheromone. The Agency has concluded that the potential for pheromone residues is not 

a dietary hazard to the general population, including infants and children. This decision was 

based on the following criteria: 1) low acute and subchronic mammalian toxicity, 2) the known 

metabolism; and 3) the history of safe use of similar SCLPs.

5. Cumulative Effects

Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to consider the cumulative effects of 

exposure to (E,Z)-7,9-Dodecadien-1-yl acetate and to other substances that have a common 

mechanism of toxicity. These considerations include the possible cumulative effects of such 

residues on infants and children. (E,Z)-7,9-Dodecadien-1-yl acetate has a non-toxic mode of 

action. Thus, there is no indication or any evidence to suggest that this biochemical pesticide 

shares any common mechanisms of toxicity with other substances. Therefore, cumulative 

exposure concerns are not anticipated for the product Isomate-EGVM. 

6. Risk Characterization 

(E,Z)-7,9-Dodecadien-1-yl acetate is a synthetic semiochemical that acts via a non-toxic mode of 

action on a specific insect pest. Givent the low toxicity of lepidopteran pheromones in animal 

testing, and the expected low exposure to humans, no risk to human health is expected from use 

of the product Isomate-EGVM. The Agency has considered the various routes of exposure and 

potential risks of the product and determined that the proposed use of the active ingredient does 

not pose significant risk to all populations, including infants and children. 

C. ENVIRONMENTAL ASSESSMENT 

1. Ecological Hazards 
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Biopesticides Registration Action Document

According to 40 CFR 158.2060(a)(2), SCLPs when applied at up to a maximum use rate of 150 

grams active ingredient/acre/year, and that are not expected to available to avian species, are not 

required to address non-target toxicity data requirements. Isomate-EGVM is a synthetic 

pheromone that is subject to section 180.2060(a)(2). This compound acts on a select group of 

insects and has a non-toxic mode of action. 

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

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 

Given that Isomate-EGVM has a non-toxic mode of action, that it is not toxic to any species (i.e., 

target or non-target organisms), and that its use pattern requires application via retrievable twist 

tie dispensers, placed directly in the vineyards, EPA determines that it will "No Effect" on 

current listed threatened or endangered species and 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 
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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 

As set forth above, EPA has determined that Isomate-EGVM presents no issues of toxicological, 

ecological, or environmental concern. Accordingly, EPA is granting a time-limited registration 

for Isomate-EGVM under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide 

Act (FIFRA). On October 1, 2009, EPA announced a new policy to provide a more meaningful 

opportunity for the public to comment on major registration decisions in advance of EPA's final 

decision. 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; first residential use; and any registration decision for 

which the Agency believes there may be substantial public interest. 

Notwithstanding that the current action on Isomate-EGVM qualifies as a “new active ingredient” 

under the new policy, EPA believes that it is in the best interests of the public and the 

environment to issue the registration for Isomate-EGVM without delay. As discussed above, 

acute toxicity data for Isomate-EGVM demonstrate that it is either toxicity category III or IV. 

Isomate-EGVM 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 IsomateEGVM in accordance with approved label directions. EPA has not identified any toxic 

endpoints for non-target mammals, birds, plants, aquatic, or soil organisms. There are no 

concerns for any threatened or endangered species. Thus, given that Isomate-EGVM has very 

low toxicity and presents little, if any, risk to non-target organisms, EPA concludes that it is in 

the best interests of the public and the environment to issue the registration for Isomate-EGVM 

without delay. Consistent with the Agency’s new policy for making these registration actions 

more transparent, however, EPA is issuing this registration with an initial period of one-year and, 

concurrent with its issuance, providing a 30-day public comment period on the time-limited 

registration. EPA is registering this product as a time-limited registration, with the 

understanding that public comments could bring to light new information or concerns that could 

inform EPA’s initial decision. Any subsequent action taken by EPA, will be made in the context 

of information received during the public comment period. 

We note that, pursuant to FIFRA Section 3(c)(4), we have provided notice of the receipt of the 

application to register Isomate-EGVM, and opened a 30-day comment period on the receipt of 

the application. In addition, the notice included a profile of the product and the active ingredient, 

and a preliminary risk assessment. In addition, given the urgent circumstances of a potential 

EGVM infestation, and the need to begin mating disruption efforts as soon as possible after 

insect emergence, EPA noted its intent to register Isomate-EGVM – provided no contrary 

information was received during the comment period. EPA received a total of thirteen 

comments on the notice of receipt. Twelve comments supported immediate registration of 

Isomate-EGVM. One comment opposed the registration of Isomate-EGVM, but did not provide 

any substantive basis supporting that position. That comment also did not provide any data or 

information calling into question EPA's risk assessment. All comments have been included in 

the docket. 
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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. 

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). 
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Biopesticides Registration Action Document

VII. APPENDIX A. DATA REQUIREMENTS (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. 

 Waiver Requests: MRID Number 4791181-00 

 Product Chemistry Data: MRID Number 479118-01