BIOPESTICIDES REGISTRATION ACTION DOCUMENT

(E,E)-8,10-Dodecadien-1-yl Acetate

 PC Code: 128004

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

January 8, 2015
(E,E)-8,10-Dodecadien-1-yl Acetate

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TABLE OF CONTENTS

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

II. ACTIVE INGREDIENT OVERVIEW.............................................................................. 7

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

A. Classification ........................................................................................................................ 7

B. Food Clearances/Tolerances............................................................................................... 7

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

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

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

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

2. Endocrine Disruptors....................................................................................................................................8

3. Dose Response Assessment ...........................................................................................................................9

4. Food Quality Protection Act (FQPA) Considerations................................................................................9

5. Occupational, Residential, School and Day Care Exposure and Risk Characterization ......................10

6. Cumulative Effects......................................................................................................................................10

7. Risk Characterization .................................................................................................................................10

C. Environmental Assessment ............................................................................................... 11

1. Ecological Hazards......................................................................................................................................11

2. Environmental Fate and Ground Water Data..........................................................................................11

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

4. Endangered Species Assessment ................................................................................................................11

D. Efficacy Data ..................................................................................................................... 11

V. RISK MANAGEMENT DECISION................................................................................ 12

A. Determination of Eligibility for Registration .................................................................. 12

B. Regulatory Decision........................................................................................................... 12

C. Environmental Justice ....................................................................................................... 13

VI. ACTIONS REQUIRED BY REGISTRANTS................................................................. 13

A. Reporting of Adverse Effects............................................................................................... 14

B. Reporting of Hypersensitivity Incidents.......................................................................... 14
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VII. APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158-SUBPART U).......... 14

VIII. APPENDIX B. ............................................................................................................. 15

IX. APPENDIX C.................................................................................................................... 16

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ............................................. 16
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Branch Chief

Linda A. Hollis, M.S.

Product Chemistry/Human Health Effects/Nontarget Organisms

Russell S. Jones, Ph.D., Senior Biologist

Regulatory Action Leader

Colin G. Walsh, M.S., Biologist
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I. EXECUTIVE SUMMARY:

(E,E)-8,10-Dodecadien-1-yl acetate is a new technical grade synthetic Straight-Chain 

Lepidopteran Pheromone (SCLP) biochemical pesticide active ingredient. This synthetic SCLP

pheromone is structurally similar to, and mimics, a naturally occurring pheromone produced by 

the female filbertworm, Synanthedon scitula, to attract males for mating. This synthetic technical 

grade active ingredient (TGAI), (E,E)-8,10-Dodecadien-1-yl acetate, is intended to mitigate the 

effects of the filbertworm by disrupting the normal mating cycle of this pest in pomegranates and 

other pome fruits and hazelnuts and other tree nut crops. The TGAI will be formulated into the 

proposed end-use product (EP), Isomate® FBW Ring (EPA File Symbol No. 53575-UL), at a 

nominal concentration 88.93%. The EP is a twin-tube ring dispenser that will be placed on lateral 

branches in the upper third of the tree canopy. 

SCLPs have been well characterized by the Agency since 1994 when the Agency issued a final 

rule establishing an exemption from the requirement of a tolerance for residues from the use of 

lepidopteran pheromones that are naturally occurring compounds, or identical or substantially 

similar synthetic compounds (40 CFR 180.1153). In addition, EPA’s regulations at 40 CFR 

158.2050(a)(2) and 158.2060(a)(2) exempt SCLP manufacturing-use products from human 

health and environmental toxicology data requirements. These data were waived based on the 

criteria presented in the Organisation for Economic Co-operation and Development (OECD)

publication - Guidance for Registration Requirements for Pheromones and Other 

Semiochemicals Used for Pest Control (OECD, 2002; 

http://www.epa.gov/pesticides/biopesticides/regtools/index.htm). No risks to human health are 

expected from the use of lepidopteran pheromones based on demonstrated low toxicity in animal 

testing and expected low exposure to humans. Furthermore, adverse effects to non-target 

organisms are not expected because pheromones are released in very small quantities in the 

environment and act on a select group of insects. Thus, given that these compounds present both 

low hazard and low exposure, the Agency has determined that, when used as directed, they 

present low risk to both humans and non-target organisms. 

This Biopesticides Registration Action Document (BRAD) serves as an additional chapter to be 

added to the original SCLP BRAD issued by the Agency in 2001 (SCLP BRAD update in 2008) 

(http://www.epa.gov/pesticides/chem_search/reg_actions/registration/decision_G-109_02-Oct08.pdf). This chapter is specific to (E,E)-8,10-Dodecadien-1-yl acetate, a synthetic SCLP of the 

female filbertworm, Synanthedon scitula. Product chemistry data requirements for the EP, 

Isomate® FBW Ring, were satisfied by acceptable guideline studies. Data waivers submitted to 

address human health and environmental toxicology data requirements for the EP are acceptable. 

BPPD has reviewed the data and information in support of the requirements for granting 

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

(FIFRA). BPPD has determined that the data and information submitted adequately satisfy 

current data requirements (please refer to 40 CFR Subpart U § 158.2000). 

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

policy, EPA provides a public comment period prior to making a registration decision for the 
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following types of applications: new active ingredients, first food use, first outdoor use, first 

residential use; and any registration decisions for which the Agency believes there may be 

substantial public interest. 

Consistent with the policy of making registration actions more transparent, (E,E)-8,10-

Dodecadien-1-yl acetate is subject to a 15-day comment period as a “new active ingredient.” 

EPA has established a comment period of 15 days on the basis of (E,E)-8,10-Dodecadien-1-yl 

acetate’s minimal toxicity, the determination that (E,E)-8,10-Dodecadien-1-yl acetate presents 

low risk of any adverse effects to human health and the environment, and the fact that SCLPs, 

which includes this new active ingredient, have been well characterized and studied by the 

Agency and have shown a long history of safe use. This new active ingredient is also expected to 

help reduce the use of conventional chemicals that are used against the target pest, the 

filbertworm, such as the insecticides that contain carbaryl and esfenvalerate. The notice for this 

comment period includes the draft BRAD and the draft product label for the EP, Isomate® FBW 

Ring, which contains this new active ingredient, (E,E)-8,10-Dodecadien-1-yl acetate. The docket 

identification (ID) number is EPA-HQ-OPP-2014-0892. The Agency believes that based on the 

risk assessment and information submitted in support of the registration of the EP containing 

(E,E)-8,10-Dodecadien-1-yl acetate, it is in the best interests of the public to issue the 

registration for Isomate® FBW Ring. The basis for this decision can be found in the risk 

assessment for (E,E)-8,10-Dodecadien-1-yl acetate, which is characterized in this BRAD. 
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II. ACTIVE INGREDIENT OVERVIEW

Common Name: (E,E)-8,10-Dodecadien-1-yl acetate

 Chemical Names: (8E,10E)-Dodeca-8,10-dien-1-yl acetate; (E,E)-8,10-Dodecadien1-ol acetate; (8E,10E)-Dodecadien-1-yl acetate; 8,10-Dodecadien1-ol, 1-acetate, (8E,10E)-; trans-8, trans-10-Dodecadienyl acetate

Trade & Other Names: Filbertworm pheromone

 CAS Registry Number: 53880-51-6

OPP Chemical Code: 128004

Type of Pesticide: Straight-Chain Lepidopteran Pheromone (SCLP); mating

disruptant for filbertworm pheromone

III. REGULATORY BACKGROUND

On June 30, 2014, EPA received an application filed by Pacific Biocontrol Corporation, 575 

Viewridge Drive, Angwin, CA 94508, to register the product, Isomate® FBW Ring (EPA File 

Symbol No. 53575-UL) containing the new SCLP active ingredient, (E,E)-8,10-Dodecadien-1-yl 

acetate. A notice of receipt (NOR) of this application, allowing for a 30-day comment period, is 

expected to be published in the Federal Register in January 2015.

A. Classification

(E,E)-8,10-Dodecadien-1-yl acetate is a synthetic Straight-Chain Lepidopteran Pheromone 

(SCLP) and is classified as a biochemical pesticide.

B. Food Clearances/Tolerances 

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/year

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

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

butterflies appear, they normally emit pheromones and humans are naturally exposed to these 

pheromones without knowledge and without any adverse reactions.
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IV. RISK ASSESSMENT

A. Active Ingredient Characterization

(E,E)-8,10-Dodecadien-1-yl acetate is a technical grade synthetic SCLP. This pheromone is

structurally similar to, and mimics, a naturally occurring pheromone produced by the female 

filbertworm, Synanthedon scitula, to attract males for mating. EPA reviewed the applicant’s data 

on the product formulation, production and packaging and determined that they all met current 

Agency standards. Acceptable results were provided regarding the preliminary analysis of five 

batches of the product. All required physical and chemical characteristics were adequately 

presented. 

All product chemistry data requirements for registration of (E,E)-8,10-Dodecadien-1-yl acetate

have been satisfied. 

For more information regarding product chemistry data requirements, refer to Tables 1 and 2 in 

Appendix A. 

B. Human Health Assessment

1. Toxicology

The EP, Isomate® FBW Ring, has a low application rate (not to exceed 150 grams active 

ingredient/acre/year) and expected exposure to humans is low. SCLP’s are exempt from the 

requirement of a tolerance (40 CFR 180.1153); therefore, dietary exposure is not a concern. 

Additionally, there will be no purposeful exposure to human skin, and inhalation exposure is 

negligible. 

For acute toxicity data requirements, toxicity categories are assigned based on the hazard(s) 

identified from studies and/or information on file with the Agency. The active ingredient is 

classified into Toxicity Category I, II, III or IV where Toxicity Category I indicates the highest 

toxicity and Toxicity Category IV indicates the lowest toxicity. Based on historical mammalian 

toxicity data for arthropod pheromones, the toxicity categories for the EP are: 1) acute oral 

toxicity – category IV, 2) acute dermal toxicity – category III-IV, 3) acute inhalation toxicity –

category III-IV, 4) minimal eye irritation, and 5) minimal skin irritation.

Adequate information and scientific rationales to address all toxicity requirements for this 

product were submitted by the applicant. All toxicology data requirements for (E,E)-8,10-

Dodecadien-1-yl acetate have been satisfied.

2. Endocrine Disruptors

As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) 

section 408(p), the EPA has developed the Endocrine Disruptor Screening Program (EDSP) and 

has begun to implement the screening program that is to be used to test all pesticides in order to 
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determine whether certain substances (including pesticide active and other ingredients) may have 

an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, 

or other such endocrine effects as the Administrator may designate.” FFDCA section 408(p)(4) 

authorizes the Administrator, by order, to exempt from the requirements of the Estrogenic 

Substances Screening Program a biologic substance or other substance if a determination is made 

that the substance is not anticipated to produce any effect in humans similar to an effect 

produced by a naturally occurring estrogenic substance. Between October 2009 and February 

2010, the EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 

58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for 

screening under the EDSP was published on June 14, 2013, and includes some pesticides 

scheduled for registration review and chemicals found in water. SCLPs, including this new 

active ingredient, are not among the group of pesticide active ingredients on the lists to be 

screened under the EDSP.

The Agency believes that SCLPs would not likely produce any effect in humans similar to an 

effect produced by a naturally occurring estrogenic substance. As such, and pursuant to Section 

408(p)(4), EPA will determine in the future whether it can exempt SCLPs from the requirements 

of the Section 408(p) EDSP. In the event the EPA does determine to exempt this substance from 

the EDSP, an order will be issued. 

For further information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines, and the Tier 1 screening battery, please visit our 

website at http://www.epa.gov/endo/.

3. Dose Response Assessment

Because no toxicological endpoints were identified for this active ingredient, a dose-response 

assessment was not required. 

4. Food Quality Protection Act (FQPA) Considerations

a. Dietary Exposure and Risk Characterization

In accordance with 40 CFR 180.1153, SCLPs such as (E,E)-8,10-Dodecadien-1-yl acetate are 

exempt from the requirement of a tolerance. Moreover, as discussed in the human health 

assessment, the EP, Isomate® FBW Ring, poses negligible toxicological hazard, including 

dietary hazard. The EP is contained in a twin-tube ring dispenser that is placed on lateral 

branches in the upper third of the tree canopy, and thus is not expected to come into direct 

contact with fruits or nuts. Therefore, given the negligible dietary hazard and the limited 

possibility of dietary exposure, the Agency concludes that there will be very low risk associated 

with dietary exposure to Isomate® FBW Ring. The Agency notes that this is consistent with the 

conclusion of the OECD, which has determined that consumption of food containing residues of 

SCLPs presents no risk (OECD, 2002).

 b. Drinking Water Exposure and Risk Characterization

No significant drinking water exposure or residues are expected to result from the pesticidal 
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usage of (E,E)-8,10-Dodecadien-1-yl acetate. This SCLP active ingredient is contained inside a 

closed twin-tube ring dispenser. The product will be applied to terrestrial areas only, and is not

applied directly to water, to areas where surface water is present, or to intertidal areas below the 

mean water mark. Aerial applications are not allowed. If used in accordance with EPA-approved 

labeling, this SCLP active ingredient is not likely to accumulate in drinking water. As a result, 

dietary and drinking water exposure to residues of (E,E)-8,10-Dodecadien-1-yl acetate is 

expected to be minimal.

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

a. Occupational Exposure and Risk Characterization

(E,E)-8,10-Dodecadien-1-yl acetate acts via a non-toxic mode of action on a specific target pest. 

The EP containing this SCLP active ingredient is intended for agricultural use only (on food 

crops). The expected exposure to workers is low because the product is contained in a twin-tube 

ring dispenser that is placed on lateral branches in the upper third of the tree canopy, and thus is 

not expected to come into direct contact with workers. In addition, the potential for dermal, eye, 

and inhalation exposure to (E,E)-8,10-Dodecadien-1-yl acetate for handlers is minimal due to the 

nature of the dispenser. The Agency also requires labels for products containing this active 

ingredient to include the appropriate signal word and precautionary statements for occupational 

workers. 

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

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

containing (E,E)-8,10-Dodecadien-1-yl acetate.

6. Cumulative Effects

Section 408(b)(2)(D)(v) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the 

Agency to consider the cumulative effect of exposure to (E,E)-8,10-Dodecadien-1-yl acetate and 

other substances that have a common mechanism of toxicity. These considerations include the 

possible cumulative effects of such residues on infants and children. (E,E)-8,10-Dodecadien-1-yl 

acetate has a non-toxic mode of action and there is no indication or evidence to suggest that this 

biochemical pesticide shares a common mechanism of toxicity with any other substance.

Therefore, cumulative exposure concerns are not anticipated for the product Isomate® FBW 

Ring.

7. Risk Characterization

(E,E)-8,10-Dodecadien-1-yl acetate is a synthetic semiochemical that acts via a non-toxic mode 

of action on a specific insect pest. Given 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® FBW Ring. 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.
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C. Environmental Assessment

1. Ecological Hazards

Ecological toxicology data for this EP are not required for a SCLP as indicated in 40 CFR 

158.2060(a)(2). According to 40 CFR 158.2060(a)(2), SCLPs applied up to a maximum use rate 

of 150 grams active ingredient/acre/year, and that are not expected to be available to avian 

species, are not required to address non-target toxicity data requirements. (E,E)-8,10-

Dodecadien-1-yl acetate is a synthetic pheromone subject to 180.2060(a)(2), which acts on a 

select group of insects and has a non-toxic mode of action. The EP is contained in a twin-tube 

ring dispenser that is not expected to be available to avian species.

2. Environmental Fate and Ground Water Data 

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

applied at a maximum use rate of 150 grams active ingredient/acre/year and is not expected to be 

available to avian species (40 CFR 158.2060(a)(2)).

3. Ecological Exposure and Risk Characterization

According to 40 CFR 158.2060(a)(2), ecological and environmental fate data are not required 

because the active ingredient is an SCLP being applied at a maximum use rate of 150 grams 

active ingredient/acre/year and is not expected to be available to avian species. (E,E)-8,10-

Dodecadien-1-yl acetate is a synthetic pheromone subject to 40 CFR 158.2060(a)(2), which acts 

on a select group of insects and has a non-toxic mode of action. 

4. Endangered Species Assessment

The Agency has not conducted a risk assessment that supports a complete endangered species 

determination. The ecological risk assessment planned during registration review will allow the 

Agency to determine whether the uses of (E,E)-8,10-Dodecadien-1-yl acetate have “no effect” or 

“may effect” federally listed threatened or endangered species (listed species) or their designated 

critical habitats. (E,E)-8,10-Dodecadien-1-yl acetate is a synthetic SCLP and is structurally 

similar to, and mimics, a naturally occurring pheromone produced by the female filbertworm, 

Synanthedon scitula, to attract males for mating. It is not known to be toxic to any insect species 

or other non-target organisms. Based on this information, it is unlikely that (E,E)-8,10-

Dodecadien-1-yl acetate will affect listed species.

Should an assessment conclude that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service 

and/or National Marine Fisheries Services (the Services), as appropriate. 

D. Efficacy Data

Product performance data must be developed for all pesticides to ensure that pesticide products 
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will perform as intended and that unnecessary pesticide exposure to the environment will not 

occur as a result of the use of ineffective products. The Agency reserves the right to require on a 

case-by-case basis, submission of efficacy data for any pesticide product registered or proposed 

for registration that are intended to be used to control a pest of significance public health 

importance and a public health pest as defined in FIFRA section 28(d) and section 2(nn). For 

further guidance on product performance requirement, refer to Pesticide Registration Notice (PR) 

Notices 96-7, 2002-1 and Explanation of Statutory Framework for Risk-Benefit Balancing for 

Public Health Pesticides (http://www.epa.gov/PR _Notices/pr1996-7.pdf) 

(http://www.ea.gov/PR_Notices/pr2002-1.pdf) and (http://www.epa.gov/pesticides/health/riskbenefit.htm).

The EP that contains this new active ingredient, (E,E)-8,10-Dodecadien-1-yl acetate, is intended 

to mitigate the effects of the filbertworm, Synanthedon scitula, by disrupting the normal mating 

cycle of this pest in pomegranates and other pome fruits and hazelnuts and other tree nut crops.

Since the filbertworm is not considered a public health pest as listed in PR Notice 2002-1, 

product performance (efficacy) was not evaluated. 

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 warrants proposed claims; (B) its labeling and other 

materials 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. 

These four criteria of the eligibility determination for pesticidal active ingredients are satisfied 

by the science assessment evaluating the subject registration application for the EP containing 

(E,E)-8,10-Dodecadien-1-yl acetate. The EP is not expected to cause unreasonable adverse 

effects on human health or the environment, and is likely to provide protection as claimed when 

used according to label instructions. Therefore, (E,E)-8,10-Dodecadien-1-yl acetate is eligible for 

registration for the labeled uses. 

B. Regulatory Decision

The data submitted fulfill the registration requirements of (E,E)-8,10-Dodecadien-1-yl acetate for 

use as synthetic SCLP pheromone that is structurally similar to, and mimics, a naturally 

occurring pheromone produced by the female filbertworm, Synanthedon scitula, to attract males 

for mating. Refer to Appendix B for product-specific information.
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Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA determined that an unconditional registration of 

(E,E)-8,10-Dodecadien-1-yl acetate is appropriate.

Consistent with the policy of making registration actions more transparent, (E,E)-8,10-

Dodecadien-1-yl acetate is subject to a 15-day comment period as a “new active ingredient.” 

EPA has established a comment period of 15 days on the basis of (E,E)-8,10-Dodecadien-1-yl 

acetate’s minimal toxicity, the determination that (E,E)-8,10-Dodecadien-1-yl acetate presents 

low risk of any adverse effects to human health and the environment, and critical need for this 

active ingredient. The notice for this comment period includes the draft Biopesticides 

Registration Action Document (BRAD) and draft product label for the EP, Isomate® FBW Ring, 

which contains this new active ingredient (E,E)-8,10-Dodecadien-1-yl acetate. The docket 

identification (ID) number is EPA-HQ-OPP-2014-0892. The Agency believes that based on the 

risk assessment and information submitted in support of the registration of the EP containing 

(E,E)-8,10-Dodecadien-1-yl acetate, it is in the best interests of the public to issue the 

registration for Isomate® FBW Ring. The basis for this decision can be found in the risk 

assessment for (E,E)-8,10-Dodecadien-1-yl acetate, which is characterized in this BRAD. 

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—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. At this time, 

EPA does not believe that use of the (E,E)-8,10-Dodecadien-1-yl acetate pesticide product will 

cause harm or a disproportionate impact on at-risk communities. For additional information 

regarding environmental justice issues, please visit EPA’s website at

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connection with the registration of the (E,E)-8,10-

Dodecadien-1-yl acetate pesticide product and determined that these data are sufficient to satisfy 

current registration data requirements. At this time, no additional data must be submitted to EPA 

for this particular product. For new uses and/or changes to existing uses, EPA may require 

additional data. 

Notwithstanding the information stated in the previous paragraph, it should be clearly understood 

that certain specific data are required to be reported to EPA as a requirement for maintaining the 

Federal registration for a pesticide product. A brief summary of these types of data are listed 

below. 
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A. Reporting of Adverse Effects

Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment 

must be submitted to EPA.

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 REQUIREMENTS (40 CFR PART 158-SUBPART U)

*NOTE: Master Record Identification (MRID) numbers listed in the following tables are 

representative of supporting data/information 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. 

TABLE 1. Product Chemistry Data Requirements for (E,E)-8,10-Dodecadien-1-yl acetate (40 CFR § 158.2030)

OCSPP Guideline Reference No./Study Description of Result MRID

880.1100 Product identity and composition The product identity and composition were 

adequately addressed. Confidential Business 

Information (CBI).

49420501

880.1200 Description of starting materials, 

production, and formulation 

process

The description of the starting materials, 

production, and formulation process were 

adequately addressed. CBI.

49420501

880.1400 Discussion of formation of 

impurities

The discussion of formation of impurities was 

adequately addressed. CBI. 49420501

830.1700 Preliminary analysis The preliminary analysis of the product was 

acceptable. CBI. 49420501

830.1750 Certified limits The certified limits listed on the Confidential 

Statement of Formula (CSF) are acceptable. 49420501

830.1800 Enforcement analytical method The enforcement analytical method was 

adequately addressed. CBI. 49420501
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TABLE 2. Physical and Chemical Properties for (E,E)-8,10-Dodecadien-1-yl acetate

Guideline Reference No./Property Description of Result MRID

830.6302 Color Light yellow transparent 49497001

830.6303 Physical State Liquid 49420501

830.6304 Odor Fatty and waxy 49497001

830.6313 Stability Stable under normal conditions, 

but avoid high temperatures under 

air exposure and direct sunlight 

exposure

49420501

830.6315 Flammability N/A, does not contain combustible 

liquids

49420501

830.6317 Storage Stability For storage beyond a month, the 

end use formulation should be kept 

in a refrigerator at 5°C (or 40°F) or 

lower

49420501

830.6319 Miscibility N/A, not an emulsifiable liquid and 

is not to be diluted with petroleum 

solvents

49420501

830.6320 Corrosion Characteristics No visible changes in either the 

end-use formulation or the 

container during the course of the 

storage stability study

49420501

830.7000 pH 3.4 49420501

830.7050 UV/Visible light absorption

Maximum absorption between 

200-280 nm

49420501

830.7100 Viscosity 6.7 mm2

/s (20°C) for end-use 

formulation

49420501

830.7200 Melting Range N/A, product is not a solid at room 

temperature.

49420501

830.7220 Boiling Range 126-128°C / 2 mmHg 49420501

830.7300 Density/Relative Density/Bulk 

Density

0.893-0.897 g/cm3(20°C ) 49420501

830.7520 Particle size, fiber length/diameter

Particle size, fiber length, and diameter distribution

N/A, not a fibrous test substance 49420501

830.7550 Partition Coefficient More than 10,000 P o/w (20°C ) 49420501

830.7840 Water Solubility Insoluble in water (less than 0.002 

g/L at 20°C); easily soluble in 

common organic solvent except 

DMSO and ethylene glycol

49420501

830.7950 Vapor Pressure 2.16x10-3 mm Hg 49420501

VIII. APPENDIX B.

For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels.
(E,E)-8,10-Dodecadien-1-yl Acetate

Page 16 of 17

Biopesticides Registration Action Document

IX. APPENDIX C.

REFERENCES

OECD. 2002. Series on Pesticides No. 12: Guidance for Registration Requirements for 

Pheromones and Other Semiochemicals Used for Arthropod Pest Control. Organization for 

Economic Cooperation and Development (OECD). Issued: 02/26/2002. 

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

EPA. 2008. Biopesticides Registration Action Document (BRAD) for Straight Chain 

Lepidopteran Pheromones (SCLP). U.S. Environmental Protection Agency Office of Pesticide 

Programs. October 2, 2008.

http://www.epa.gov/pesticides/chem_search/reg_actions/registration/decision_G-109_02-

Oct-08.pdf

REVIEWS AND OTHER REFERENCES

EPA. 2014. Memorandum from Russell S. Jones, Ph.D., to Colin Walsh. Science Review of the 

Registration of Isomate FBW Ring, a New End-Use Product (EP) Containing 88.93% (E, E)-8, 

10-Dodecadien-1-yl Acetate as its Active Ingredient. The Technical Grade of the Active 

Ingredient (TGAI) is a New Active Ingredient. U.S. Environmental Protection Agency Office of 

Pesticide Programs. December 11, 2014.

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

a.i. active ingredient

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document

CBI Confidential Business Information

CFR Code of Federal Regulations

cm centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EP end-use product

EPA Environmental Protection Agency (the “Agency”)

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g gram

gal gallon

kg kilogram

L liter

lbs pounds

m meter
(E,E)-8,10-Dodecadien-1-yl Acetate

Page 17 of 17

Biopesticides Registration Action Document

MRID No. Master Record Identification Number

mg milligram

mL milliliter

mm Hg millimeter in Mercury

MP manufacturing-use product

N/A not applicable

NE “No Effect”

nm nanometer

NOR notice of receipt

OECD Organisation for Economic Co-operation and Development

OPP Office of Pesticide Programs

OCSPP Office of Chemical Safety and Pollution Prevention

PR Notice Pesticide Registration Notice

s second

 TGAI technical grade of the active ingredient

 UV ultra-violet