BIOPESTICIDES REGISTRATION ACTION DOCUMENT



# ( E , E )

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PC Code: 128004

U.S. Environmental Protection Agency Office of Pesticide Programs Biopesticides and Pollution Prevention Division

January 8 , 201 5(E,E)
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Page 2 of 17 Biopesticides Registration Action Document TABLE OF CONTENTS

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

II. ACTIVE INGREDIENT OV ERVIEW
................................ ................................ .............. 7

III. REGULATORY BACKGROUN D
................................ ................................ ...................... 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 Dis ruptors ................................ ................................ ................................ ................................ .... 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 Effe cts ................................ ................................ ................................ ................................ ...... 10 7. Risk Characterization
................................ ................................ ................................ ................................ . 10 C. Environmental Assessment
................................ ................................ ............................... 11 1. Ecological Hazards
................................ ................................ ................................ ................................ ...... 11 2. Env ironmental 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 DECI SION
................................ ................................ ................ 12
A. Determination of Eligibility for Registration
................................ ................................ .. 12
B. Regulatory Decision
................................ ................................ ................................ ........... 12
C. Environmental Justice
................................ ................................ ................................ ....... 13

VI. ACTIONS REQUIRED BY REGISTRANTS
................................ ................................ . 13
A. R eporting of Adverse Effects
................................ ................................ ............................... 14
B. Reporting of Hypersensitivity Incidents
................................ ................................ .......... 14(E,E)
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Page 3 of 17 Biopesticides Registration Action Document
VII. APPENDIX A. DATA REQ UIREMENTS (40 CFR PA RT 158
- SUBPART U)
.......... 14

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

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

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS
................................ ............. 16(E,E)
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Page 4 of 17 Biopesticides Registration Action Document 

### BIOPESTICI DES REGISTRATION ACTION DOCUMENT (BRAD) TEAM 

## Branch Chief Linda A. Hollis, M.S. Product Chemistry/ Human Health Effects/Nontarget Organisms Russell S. Jones, P h.D., Senior Biologist Regulatory Action Leader Colin G. Walsh, M.S., Biologist(E,E)
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Page 5 of 17 Biopesticides Registration Action Document
I. EXECUTIVE SUMMARY: (E,E)

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- yl acetate is a new technical grade synthetic Straight

- Chain Lepidopteran Pheromone (SCLP) biochemical pesticide active ingredient

. Th is 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. Th is synthetic technical grade active ingredient (TGAI), (E,E)

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- yl acetate , is intended to mitigate the effects of the fi l bertworm by disrupti ng the normal mating cycle of this pest in pomegranates and other pome fruits and hazelnuts and other tree nut crops

. T he TGAI will be formulated into the proposed end

- use product (EP), Isomate ® FBW Ring (EPA File Symbol No. 53575

- UL), at a nominal concent ration 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 Develop ment ( OECD ) publication

- Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for Pest Control ( O EC D, 2002; http://www.epa.gov/pesticides/biopest icides/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, th ey 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

- Oct

08.pdf ) . This chapter is specific to (E,E)

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- yl acetate , a synthetic SCLP of the female filbertworm, Synanthedon scitula

. Product chemistry data requireme nts for the EP , Isomate® FBW Ring , were satisfied by acceptable guideline studies. Data waiver s submitted to address human health and environmental t oxicology data requi rements for the E P 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 registrati on decisions before they occur. According to this policy, EPA provide s a public comment period prior to making a registration decision for the(E,E)
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Page 6 of 17 Biopesticides Registration Action Document following types of applications: new active ingredients, first food use, first out door 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)

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- yl acetate is sub ject 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)

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- yl acetate ’s minimal toxicity, the determination that (E,E)

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- 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 include s the draft BRAD and the dra ft product label for the E P, Isomate® FBW Ring , which contain s this new active ingredient, (E,E)

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- yl acetate

. The docket identification ( ID ) number is EPA

- HQ

- OPP

- 201 4

- 0 892 . The Agency believes that based on the risk assessment and information submitted in support of the registration of the E P containing (E,E)

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- yl acetate , it is in the best interests of the public to issue the registration for Isomate® FBW R ing

. The basis for this decision can be found in the risk assessment for (E,E)

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- yl acetate , which is characterized in this BRAD.(E,E)
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Page 7 of 17 Biopesticides Registration Action Document II. ACTIVE INGREDIENT OVERVIEW
Common Name: (E,E)

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Chemical Names: (8E,10E)

- Dodeca

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- yl acetate; (E,E)

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1

- ol acetate; (8E,10E)

- Dodecadien

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- yl acetate; 8,10

- Dodecadien

1

- 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: 12 8004 Type of Pesticide: Straight

- Chain Lepidopteran Pheromone ( SCLP ) ; mating disruptant for filbertworm pheromone

III. REGULATORY BACKGROUND
On June 30 , 20 1 4 , 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 ) co ntaining the new SCLP active ingredient, (E,E)

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- 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)

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- yl acetate is a synthetic Straight

- C hain Lepidoptera n Pheromone (SCLP) and is classified as a biochemical pesticide.
B. F ood 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 act ive 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 pheromone s without knowledge and without any adverse reactions.(E,E)
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Page 8 of 17 Biopesticides Registration Action Document

IV. RISK ASSESSMENT
A. Active Ingredient Characterization (E,E )

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- yl acetate is a technical grade synthetic SCLP. This pheromone is structurally similar to, and mimic s , a naturally occurring pheromone produced by the female filbertworm, Synanthedon scitula , to attract males for mating. EPA reviewed th e 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)

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- 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 inha lation 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 E P are: 1) acute oral toxi city

– 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 w ere submitted b y the applicant. All toxicology data requirements for (E,E)

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- yl acetate have been satisfied.
2. Endocrine Disruptors
As required by the Administrator under the Federa l 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(E,E)
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Page 9 of 17 Biopesticides Registration Action Document determine whether certain s ubstances (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 hu mans 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 ine rt 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 su ch, 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. Fo r 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.g ov/endo/

. 3
. Dose Response Assessment
Because n o toxicolog ical endpoints were identified for this active ingredient , a dose

- respon se 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)

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- 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 toxico logical 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 conclude s that there will be very low risk associated with dietary exposure to Isomate® FBW Ring

. The Agency note s 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(E,E)
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Page 10 of 17 Biopesticides Registration Action Document usage of (E,E)

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. This SCLP active ingredient is contained inside a closed twin

- tube ring dispenser. The product will be applied to ter restrial 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 in gredient is not likely to accumulate in drinking water. As a result, dietary and drinking water exposure to residues of (E,E)

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- 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)

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- 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)

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- 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 includ e 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 c ontaining (E,E)

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. 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)

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- yl acetate and other substances that have a common mechanism of toxicity. These considerations include the possible cumulative effects of such re sidues on infants and children. (E,E)

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- yl acetate has a non
- toxic mode of action and there is no indication o r evidence to suggest that this biochemical pesticide shares a common mechanism of toxicity with any other substance

. Therefore, c umulative exposure concerns are not anticipated for the product Isomate® FBW Ring.
7
. Risk Characterization (E,E)

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- yl acetate is a synthetic semiochemica l that acts via a non

- toxic mode of ac tion 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 f rom 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 populatio ns, including infants and children.(E,E)
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Page 11 of 17 Biopesticides Registration Action Document

C. E nvironmental 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). Accor ding to 40 CFR 158.2060(a) (2), SCLPs applied up to a maximum use rate of 150 gr ams 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)

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- 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
E nvironmental fate data are not required for this active ingredient because it is an SCLP being applied at a maximum use rate of 150 gra ms 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
Accor ding 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 gra ms active ingredient/acre/year and is not expecte d to be available to avian species

. (E,E)

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- 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. Enda ngered 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)

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- yl acetate have “no effect” or “may effect” federally listed threatened or endangered species (listed species) or their designated critical habitats. (E,E)

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- yl acetate is a synthetic SCLP and is structurally similar t o, 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)

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- 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 wi th 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(E,E)
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Page 12 of 17 Biopesticides Registration Action Document 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 regis tered 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/risk

benefit.htm ).
The EP that contains this new active ingredient , (E,E)

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- 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 hazelnut s 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. R ISK 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 warrant s proposed claims; (B) its labeling and other materials comply with the requirements of FIFRA; (C) it will perform its in tended 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 se four criteria of the eligibility determination for pesticidal active i ngredients are satisfied by the science assessment evaluating the subject registration application for the EP containing (E,E)

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- 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)

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- yl acetate is eligible for registration for the labeled uses.
B. Regulatory Decision The data submitted fulfill the registration requirements of (E,E)

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- yl acetate for use as synthetic SCLP pheromone that is structurally similar to , and mimics, a naturally occurring pheromone produced by the female filbertworm, Sy nanthedon scitula , to attract males for mating

. Refer to Appendix B for product

- specific information.(E,E)
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Page 13 of 17 Biopesticides Registration Action Document

Conditional/Unconditional Registration All data requirements are fulfilled, and EPA determined that an unconditional registration of (E,E )

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- yl acetate is appropriate. Consistent with the policy of making registration actions more transparent, (E,E)

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- 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)

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- yl acetate ’s minimal toxicity, the determination that (E,E)

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- yl acetate presents low risk of any adverse effects to human health and the environment, and critical need for this act ive 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 contain s this new active ingredient (E,E)

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- yl acetate . The docket identification (ID) number is EPA

- HQ

- OPP

- 201 4

- 0892 . The Agency believes that based on the risk assessment and information submitted in support of the registration of the EP containing (E,E)

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- 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)

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- 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 th is time , EPA does not believe that use of the (E,E)

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- 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 we bsite at http://www.epa.gov/compliance/environmentaljustice/index.html

.

V I
. ACTIONS REQUIRED BY REGISTRANTS
EPA evaluated all data submitted in connection with the registration of the (E,E)

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- yl acetate pesticide product and determined that these data are sufficient to satisfy current registration data requirements. At this time, n o additional data must be submi tted to EPA for th is particular prod uct. 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 summa ry of these types of data are listed below.(E,E)
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Page 14 of 17 Biopesticides Registration Action Document A. R eporting of Adverse Effects Pursuant to FIFRA section 6(a)(2), r eports of all incidents of adverse effects to the environment must be submitted to EPA

. B. Reporting of Hypersensitivity Incidents
Addi tionally, 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).

VI I
. A PPENDIX A. DATA REQUIREMENTS (40 CFR P ART 158
- S UBPART 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)
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- yl acetate ( 40 CFR § 158.2030 )
OCSPP Guideline Reference No./ Study Description of Result MRID
8 8 0. 1100 Product identity and composition The product identity and composition were adequately addressed. Confidential Business

Information (CBI). 49420501

8 8 0. 1200 Description of starting materials,

production, and formulation process The description of the starting materials, production, and formulation process were adequately addressed. CBI. 49420501

8 8 0. 1400 Discussion of formation of

impurities The discussion of formation of impurities was adequately addressed. CBI. 49420501

8 3 0. 1700 Preliminary analysis The preliminary analysis of the product was acceptable. CBI. 49420501

8 3 0. 1750 Certified limits The certified limits listed on the Confidential Statement of Formula ( CSF ) are acceptable. 49420501

8 3 0. 1800 Enforcement analytical method The enforcement analytical method was adequately addressed. CBI. 49420501(E,E)
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- yl Acetate

Page 15 of 17 Biopesticides Registration Action Document

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 mm 2 /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 0.8 93

- 0.897 g/cm 3 (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 2 0 °C ); easily soluble in common organic solvent except DMSO and ethylene glycol 49420501

830.7950 Vapor Pressure 2.16 x10

- 3 mm Hg 49420501

VIII. A PPENDIX 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 fo r 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. 201 4 . Memorandum from Russell S. Jones, Ph.D., to Colin Walsh

. Scienc e Review of the Reg istration 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 , 201 4

.

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS
a.i. a ctive i ngredient 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 O CS PP Office of Chemical Safety and Pollution Prevention PR Notice Pesticide Registration Notice s second TGAI technical grade of the active ingredient UV ultra

- violet