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

February 23, 2015(E,E)-8,10-Dodecadien-1-yl Acetate Page 2 of 17 Biopesticides Registration Action Document

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 Di sruptors .......................................................................................................... .......................... 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 ....................................................................................................... 1 3

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

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

B. Reporting of Hypersensitivity Incidents .......................................................................... 13(E,E)-8,10-Dodecadien-1-yl Acetate Page 3 of 17 Biopesticides Registration Action Document

VII. APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158-SUBPART U) .......... 13

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

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

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ............................................. 16(E,E)-8,10-Dodecadien-1-yl Acetate Page 4 of 17 Biopesticides Registration Action Document



### BIOPESTICIDES REGISTRATION AC TION 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(E,E)-8,10-Dodecadien-1-yl Acetate Page 5 of 17 Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY:

(E,E)-8,10-Dodecadien-1-yl acetate is a new technical grade synthetic Straight-Chain Lepidopteran Pheromone (SCLP) biochemical pest icide active ingredient. This synthetic SCLP pheromone is structurally similar to, and mimi cs, a naturally occurring pheromone produced by the female filbertworm, Cydia latiferreana , 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 disr upting 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-t ube ring dispenser that will be placed on lateral branches in the upper th ird of the tree canopy.

SCLPs have been well characterized by the Agency since 1994 when the Agency issued a final rule establishing an exemption fr om the requirement of a toleran ce for residues from the use of lepidopteran pheromones that are naturally occu rring 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) exem pt SCLP manufacturing-us e products from human

health and environmental toxico logy data requirements. These da ta were waived based on the criteria presented in the Or ganisation 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/bio pesticides/reg tools/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 expos ure 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 thes e compounds present both low hazard and low exposure, the Agency has dete rmined 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/c hem_search/reg_actions/reg istration/decision_G-109_02-Oct08.pdf ). This chapter is specific to (E,E)-8,10-Dodecad ien-1-yl acetate, a synthetic SCLP of the female filbertworm, Cydia latiferreana . Product chemistry data requirements for the EP, Isomate® FBW Ring, were satisfied by acceptable guideline studies. Data waivers submitted to

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

BPPD has reviewed the data and informati on in support of the requirements for granting registration under Section 3(c)(5) of the Federal Insecticid e, 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 meani ngful opportunity for the public to participate on major registration deci sions before they occur. According to this policy, EPA provides a public comment period prio r to making a registration decision for the(E,E)-8,10-Dodecadien-1-yl Acetate Page 6 of 17 Biopesticides Registration Action Document

following types of applications: new active ingredients, first f ood use, first outdoor use, first residential use; and any regist ration decisions for which the Agency believes there may be substantial public interest.

Consistent with the policy of making regist ration actions more transparent, (E,E)-8,10- Dodecadien-1-yl acetate was subj ect to a 15-day comment period as a “new active ingredient.” EPA had established a comment period of 15 da ys on the basis of (E,E)-8,10-Dodecadien-1-yl acetate’s minimal toxicity, the determination th at (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 conventi onal chemicals that are used against the target pest, the filbertworm, such as the insecticides that cont ain carbaryl and esfenvalerate. The notice for this comment period included the draft BRAD and the dr aft 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 public participation comment period was open from January 15, 2015 to Janua ry 30, 2015. No comments were received during this comment period.

The Agency believes that based on the risk asse ssment and information submitted in support of the registration of the EP containing (E,E)-8,10-Dodecad ien-1-yl acetate, it is in the best interests of the public to issue the regist ration for Isomate® FBW Ring. The basis for this decision can be found in the risk assessment for (E,E)-8,10-Dodecadi en-1-yl acetate, which is characterized in

this BRAD.(E,E)-8,10-Dodecadien-1-yl Acetate Page 7 of 17 Biopesticides Registration Action Document

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)-Dodecadie n-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 ingredie nt, (E,E)-8,10-Dodecadien-1-yl acetate. A notice of receipt (NOR) of this a pplication, allowing for a 30-day comment period, was published in the Federal Register on January 21, 2015 (80 FR 2929). No comments were received following this publication.

A. Classification

(E,E)-8,10-Dodecadien-1-yl acetat e is a synthetic Straight-Cha in Lepidopteran Pheromone (SCLP) and is classified as a biochemical pesticide.

B. Food Clearances/Tolerances

SCLPs are exempt from the requirement of a tole rance 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 practic es, and in indoor post-harvest treatment in or on all stored food commodities when applied/us ed 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 180.115 3). Pheromones are ubiquitous in the environment, and are not considered to be air po llutants. 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.(E,E)-8,10-Dodecadien-1-yl Acetate Page 8 of 17 Biopesticides Registration Action Document

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

(E,E)-8,10-Dodecadien-1-yl acetat e is a technical grade synthetic SCLP. This pheromone is structurally similar to, and mimics, a naturally occurring pheromone produced by the female filbertworm, Cydia latiferreana , to attract males for mating. EPA reviewed the applicant’s data on the product formulation, production and packagi ng and determined that they all met current Agency standards. Acceptable re sults were provided re garding the preliminary analysis of five batches of the product. All required physical a nd chemical characteristics were adequately presented.

All product chemistry data requirements for regi stration of (E,E)-8,10-D odecadien-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 applica tion 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); ther efore, dietary exposur e 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 fi le 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 th e lowest toxicity. Base d on historical mammalian toxicity data for arthropod phero mones, the toxicity categories fo r 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 irrita tion, 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 Endocr ine Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be used to test all pesticides in order to determine whether certain substances (including pe sticide active and other ingredients) may have(E,E)-8,10-Dodecadien-1-yl Acetate Page 9 of 17 Biopesticides Registration Action Document

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

or other such endocrine effect s as the Administrator may designate.” FFDCA section 408(p)(4) authorizes the Administrator, by order, to ex empt 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 anticip ated 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/dat a call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients a nd 9 inert ingredients. A second list of chemicals identified for screening under the EDSP was published on J une 14, 2013, and includes some pesticides scheduled for registration review and chemi cals found in water. SCLPs, including this new active ingredient, are not among the group of pes ticide active ingredient s 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 estrogeni c substance. As such, and pursuant to Section 408(p)(4), EPA will determine in the fu ture 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 ED SP, 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 identifie d 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 toxicologi cal 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 e xpected 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 notes that this is consistent with the conclusion of the OECD, which has determined th at consumption of food containing residues of SCLPs presents no risk (OECD, 2002).

b

. Drinking Water Exposure and Risk Characterization

No significant drinking water expos ure or residues are expected to result from the pesticidal usage of (E,E)-8,10-Dodecadien-1-yl acetate. This SCLP active ingredient is contained inside a(E,E)-8,10-Dodecadien-1-yl Acetate Page 10 of 17 Biopesticides Registration Action Document

closed twin-tube ring dispenser. The product will be applied to terr estrial areas only, and is not applied directly to water, to areas where surface wa ter 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 likel y to accumulate in drinking water. As a result, dietary and drinking water expos ure 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 act s via a non-toxic mode of action on a specific target pest. The EP containing this SCLP active ingredient is intended for agricu ltural 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 th e 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 requ ires labels for products containing this active ingredient to include the appropriate signal wo rd and precautionary statements for occupational

workers.

b. Residential, School and Day Ca re Exposure and Risk Characterization

No outdoor or indoor residential, school, or day care uses ar e 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 co mmon 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 mechanis m 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 le pidopteran 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 ha s 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 p opulations, including infants and children.(E,E)-8,10-Dodecadien-1-yl Acetate Page 11 of 17 Biopesticides Registration Action Document

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/acr e/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 phero mone 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 i ngredient/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 bei ng applied at a maximum use rate of 150 grams active ingredient/acre/year and is not expected to be availa ble to avian species. (E,E)-8,10- Dodecadien-1-yl acetate is a synthetic pheromo ne 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 assessmen t that supports a complete endangered species determination. The ecological risk assessment pla nned during registration re view 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 endang ered species (listed species) or their designated critical habitats. (E,E)-8,10-Dodecadien-1-yl acet ate is a synthetic SCLP and is structurally similar to, and mimics, a naturally occurring phe romone produced by the female filbertworm, Cydia latiferreana , to attract males for mating. It is not known to be toxic to any insect species or other non-target organisms. Based on this inform ation, it is unlikely that (E,E)-8,10-Dodecadien1-yl acetate will affect listed species.

Should an assessment conclude that a pesticid e’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service

and/or National Marine Fi sheries Services (the Serv ices), as appropriate.

D. Efficacy Data

Product performance data must be developed for a ll pesticides to ensure that pesticide products will perform as intended and that unnecessary pe sticide exposure to the environment will not(E,E)-8,10-Dodecadien-1-yl Acetate Page 12 of 17 Biopesticides Registration Action Document

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 Explanatio n 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_N otices/pr2002-1.pdf) and ( http://www.epa.gov/pest icides/health/riskbenefit.htm).

The EP that contains this new active ingredient, (E,E)-8,10-Dodecadi en-1-yl acetate, is intended to mitigate the effects of the filbertworm, Cydia latiferreana , by disrupting the normal mating cycle of this pest in pomegranates and other pom e 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 regi stration 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 requi rements of FIFRA; (C) it will perform its intended function

without unreasonable adverse eff ects on the environment; and (D) when used in accordance with widespread and commonly recogniz ed practice, it will not genera lly cause unreasonable adverse

effects on the environment.

These four criteria of the eligibility determina tion 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 prot ection as claimed when used according to label instructi ons. 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 requir ements of (E,E)-8,10-Dodecadien-1-yl acetate for use as synthetic SCLP pheromone that is stru cturally similar to, and mimics, a naturally occurring pheromone produced by the female filbertworm, Cydia latiferreana , to attract males for mating. Refer to Appendix B fo r product-specific information.

Conditional/Unconditional Registration

All data requirements are fulf illed, and EPA determined that an unconditional registration of (E,E)-8,10-Dodecadien-1-yl acetate is appropriate.(E,E)-8,10-Dodecadien-1-yl Acetate Page 13 of 17 Biopesticides Registration Action Document

C. Environmental Justice

EPA seeks to achieve environmen tal justice—the fair treatment and meaningful involvement of all people regardless of race, color, national or igin, or income—with respect to the development, implementation, and enforcement of environmental laws, regulations, and po licies. 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/en vironmentaljustice/index.html

.

VI. ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connecti on with the registrati on of the (E,E)-8,10- Dodecadien-1-yl acetate pesticide product and determined that these data are sufficient to satisfy current registration data requirement s. 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 pr evious paragraph, it should be clearly understood that certain specific data are requi red to be reported to EPA as a requirement for maintaining the Federal registration for a pesticide product. A br ief summary of these t ypes of data are listed

below.

A. Reporting of Adverse Effects

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

must be submitted to EPA.

B. Reporting of Hypersensitivity Incidents

Additionally, all incidents of hype rsensitivity (including both suspected and confirmed incidents) must be reported to the Agency unde r the provisions of 40 CFR Part 158.2050(d).

VII. APPENDIX A. DATA REQUIREM ENTS (40 CFR PART 158-SUBPART U)

*NOTE: Master Record Identification (MRID) numbers listed in the following tables are representative of supporting da ta/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 th is active ingredient.(E,E)-8,10-Dodecadien-1-yl Acetate Page 14 of 17 Biopesticides Registration Action Document

TABLE 1. Product Chemistry Data Requirement s 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(E,E)-8,10-Dodecadien-1-yl Acetate Page 15 of 17 Biopesticides Registration Action Document

TABLE 2. Physical and Chemical Properti es 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 di rect 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 0.893-0.897 g/cm 3 (20°C ) 49420501

830.7520 Particle size, fiber length/diameter 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 informatio n, please refer to http://w ww.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: Gu idance for Registration Requirements for

Pheromones and Other Semiochemicals Used fo r Arthropod Pest Contro l. Organization for Economic Cooperation and Devel opment (OECD). Issued: 02/26/2002. http://www.epa.gov/pesticides/bio pesticides/reg tools/index.htm

EPA. 2008. Biopesticides Regist ration Action Document (B RAD) for Straight Chain Lepidopteran Pheromones (SCLP). U.S. Environm ental Protection Agency Office of Pesticide Programs. October 2, 2008. http://www.epa.gov/pesticides/chem_search /reg_actions/registr ation/decision_G-109_02- Oct-08.pdf

REVIEWS AND OTHER REFERENCES

EPA. 2014. Memorandum from Russell S. Jones, P h.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 Ingr edient. The Technical Grade of the Active Ingredient (TGAI) is a New Activ e Ingredient. U.S. Environmenta l Protection Agency Office of Pesticide Programs. December 11, 2014.

X. GLOSSARY OF ACRONYMS AND A BBREVIATIONS

a.i. active ingredient BPPD Biopesticides and Pollu tion 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 Safe ty and Pollution Prevention PR Notice Pesticide Registration Notice

s second

TGAI technical grade of the active ingredient

UV ultra-violet