OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENC Y
WASHINGTON, D.C. 20460

BIOPESTICIDES REGISTRATION ACTION DOCUMENT



## (E,Z)-2,13-Octadecadien-1-yl Acetate

PC Code 117242

(E,Z)-2,13-Octadecadien-1-ol

PC Code 117244

SEX PHEROMONES OF THE DOGWOOD BORER

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

July 20, 2011

This document is for informational purposes only an d is representative of the Agency’s justification in registering products containing this active ingredient. This is not a legal document.(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 2 of 12 Biopesticides Registration Action Document

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY .................................................................................................. 4

II. ACTIVE INGREDIENT OVERVIEW .............................................................................. 6

III. REGULATORY BACKGROUND...................................................................................... 6

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

B. Food Clearance/Tolerances ................................................................................................. 6

IV. RISK ASSESSMENT ........................................................................................................... 7

A. Active Ingredient Characterization.................................................................................... 7

B. Human Health Assessment.................................................................................................. 7
1. Toxicology Assessment ...................................................................................................... ............................ 7 2. Dose Response Assessment ................................................................................................... ........................ 7 3. Food Quality Protection Act (FQPA) Consideration ........................................................................... ...... 8 4. Occupational, Residential, School and Da y Care Exposure and Risk Characterization ........................ 8

5. Cumulative Effects ......................................................................................................... ............................... 8

6. Risk Characterization ...................................................................................................... ............................. 9

C. Environmental Assessment ................................................................................................. 9
1. Ecological Effects and Hazards Assessment .................................................................................. ............. 9

2. Environmental Fate an d Ground Water Data ................................................................................... ......... 9 3. Ecological Exposure a nd Risk Characterization .............................................................................. .......... 9 4. Endangered Species Assessment .............................................................................................. .................... 9

D. Product Performance Data (Efficacy) ................................................................................ 9

V. RISK MANAGEMENT DECISION ................................................................................. 10

A. Determination of Eligibility for Registration .................................................................. 10

B. Regulatory Decision ........................................................................................................... 10

C. Environmental Justice ....................................................................................................... 1 1

VI. ACTIONS REQUIRED BY REGISTRANTS.................................................................. 11

A. Reporting of Adverse Effects ............................................................................................ 11

B. Reporting of Hypersensitivity Incidents .......................................................................... 11

VII. APPENDIX A: References ................................................................................................. 12(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 3 of 12 Biopesticides Registration Action Document

BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Office of Pesticide Programs:

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

Gina Casciano Regulatory Action Leader

Linda Hollis Branch Chief Manying Xue Chemist(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 4 of 12 Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY

The new active ingredients (E,Z)-2,13-octadeca dien-1-yl acetate and (E,Z)-2,13-octadecadien-1- ol are technical grade synthe tic Straight-Chain Lepidopteran Pheromones (SCLPs). These pheromones are structurally similar to, and mi mic, naturally occurring pheromones produced by the female dogwood borer, Synanthedon scitula , to attract males for mating. These synthetic technical grade active ingredients (TGAIs), (E ,Z)-2,13-octadecadien-1-yl acetate and (E,Z)- 2,13-octadecadien-1-ol, are intended to mitigate the effects of the dogwood borer by disrupting the normal mating cycle of this pest in pome fr uit, stone fruit, and tree nut crops, and in ornamental nursery crops. The pesticide product formulated with these TGAIs will be dispensed in polymeric tubes. The product consists of two tubes fused together in a parallel fashion, one containing the end-use product formulation and the other containing a wire. The wire allows the entire dispenser to be twisted around the branch es of a tree. The product will only be dispensed in this manner. The product will not be appl ied through any type of irritation system. The product will be applied in the spring be fore dogwood borer adult emergence.

The dogwood borer, Synanthedon scitula, is a documented pest of at least 19 species of fruit, nut,

and ornamental trees in the eas tern United States and Canada (Zhang et al., 2005). The larvae feed on the inner bark of live, healthy trees. The damage d area of the trunk or branch swells and eventually the bark will fall off; infested br anches and limbs will die. Dogwood borers often will not kill the tree in the first year, but reinfestati on in successive years will generally kill the tree. The end-use product ISOMATE ® -DWB, containing 5.46% and 0.27% of the active ingredients (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13- octadecadien-1-ol, resp ectively, is intended to disrupt the mating of the dogw ood borer, therefore decreasing the number of larvae to feed on

trees later that season.

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 OECD publication - Guidance for Registration Requirements for

Pheromones and Other Semiochemicals Us ed for Pest Control (OCED, 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 exposur e 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 ( http://www.epa.gov/opp00001/bi opesticides/ingredie nts/tech_docs/brad_129109.pdf ). This chapter is specific to (E,Z)-2,13- octadecadien-1-yl acetate a nd (E,Z)-2,13-octadecadien-1-ol, synthetic SCLPs of the female dogwood borer, Synanthedon scitula . Product chemistry data requirements for the end-use product (EP), ISOMATE ® -DWB, were satisfied by acceptable(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 5 of 12 Biopesticides Registration Action Document

guideline studies. Data waiver rationale submitt ed to address human health and environmental toxicology data requirements for the end-use product is acceptable.

On October 1, 2009, EPA announced a new policy to provide a more meani ngful opportunity for the public to participate in major registration decisions before they occur. According to this new policy, EPA intends to provide a public comment period prior to making a registration decision for, at minimum, the following types of applicati ons: new active ingredients, first food use, first outdoor use, first residential use, or actions for which EPA anticipates significant publi c interest. Consistent with the new policy of making regi stration actions more transparent, (E,Z)-2,13- octadecadien-1-yl acetate and (E,Z)-2,13-octade cadien-1-ol are subject to a 30-day comment period as “new active ingredients, ” the registration of which would result in a “first outdoor use, first food use, and first residen tial use.” The intent of the 30-da y comment period is to provide a more meaningful opportunity for the public to part icipate in major registration decisions before they occur. The notice for this comment peri od includes the draft BRA D and the draft product

label for ISOMATE ® -DWB. The docket ID is EPA-HQ- OPP-2011-0247. While a final decision on registration is contingent upon review and considera tion of public comments, at this time the Agency believes that based on the risk assessmen t and information submitted in support of the registration of (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-ol, it is in the public interest to issue these registrations. The basis for this decision can be found in the risk assessment for (E,Z)-2,13-octadecadien-1-yl aceta te and (E,Z)-2,13-octadecadien-1-ol, which is

characterized in this BRAD.(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 6 of 12 Biopesticides Registration Action Document

II. ACTIVE INGREDIENT OVERVIEW

Common Name:

Chemical Name:

Trade & Other Names :

CAS Registry Number:

OPP Chemical Code:

Type of Pesticide: (E,Z)-2,13-octadecadien-1- yl acetate

(2E,13Z)-2,13- octadecadien-1-yl acetate

Dogwood Borer

Pheromone

86252-65-5

117242

Mating disruptant for dogwood borer (E,Z)-2,13-octadecadien-1-

ol

(2E,13Z)-2,13-

octadecadien-1-ol

Dogwood Borer

Pheromone

123551-47-3

117244

Mating disruptant for dogwood borer

III. REGULATORY BACKGROUND

On February 10, 2011, Pacific Biocontrol Corpora tion submitted an application for registration of end-use product (EP) Isomate-DWB, c ontaining the active i ngredients (E,Z)-2,13- octadecadien-1-yl acetate and (E,Z)-2,13-octa decadien-1-ol, at 5.46% and 0.27%, respectively. A notice of receipt of the application for regist ration of (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-ol as new active ingredie nts was published in the Federal Register on Wednesday, March 30, 2011 (76 FR 17644), with a 30-day comment period. No comments were received in response to this publication.

A. Classification

(E,Z)-2,13-Octadecadien-1-yl acet ate and (E,Z)-2,13-octadecadien-1-ol are synthetic Straightchain Lepidopteran Pheromones and are cl assified as biochemical pesticides.

B. Food Clearance/Tolerances

SCLPs are exempt from the requirement of a to lerance in or on all raw agricultural commodities when applied to growing crops at a rate not to exceed 150 grams of activ e 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 180.1153). 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,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 7 of 12 Biopesticides Registration Action Document

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

(E,Z)-2,13-Octadecadien-1-yl a cetate and (E,Z)-2,13-octadecadie n-1-ol are technical grade synthetic straight-chain lepidopt eran pheromones. These pheromone s are structurally similar to, and mimic, naturally oc curring pheromones produced by the female dogwood borer, Synanthedon scitula , to attract males for mating. EPA revi ewed the applican t’s data on the product formulation, production and packaging and de termined that they all met current Agency standards. Acceptable results were provided regardi ng the preliminary analysis of five batches of the product. All required physical and chemical characteristics were ad equately presented.

B. Human Health Assessment

1. Toxicology Assessment

The end-use product ISOMATE ® -DWB has a low application rate (not to exceed 150 grams active ingredient/acre/year) and expected exposure to humans is low. Adequate information and

scientific rationales to addre ss all toxicity require ments for this product were submitted by the applicant. SCLP’s are exempt from the requirement of a tolerance (40 CFR 180.1153); therefore, dietary exposure is not a concern. Additionall y, there will be no purpos eful exposure to human skin, and inhalation exposure is negligible. In summary, no risk to human health is expected

from the use of ISOMATE ® -DWB.

2. Dose Response Assessment

ISOMATE ® -DWB consists of two parallel polymeri c tubes fused together , one containing the end-use product formulation and the other c ontaining a wire. The wire allows the entire dispenser to be twisted around th e branch of a tree. ISOMATE ® -DWB contains the active ingredients (E,Z)-2,13-octadecadi en-1-yl acetate and (E,Z)-2,13- octadecadien-1-ol at 5.46% and 0.27%, respectively. The product al so contains two other synt hetic dogwood borer pheromones that were previously registered with the Agen cy. The application use ra te on the product label

considers the total sum of all four of these pheromones and sets a total allowable application rate of 200 dispensers per acre, or 11.02 grams total pheromone, per applica tion. Application must not exceed 150 grams of total pheromone/acre/y ear. Thus, if applying at maximum label rate during each application, the applic ator would need to apply at a frequency greater than thirteen times per year in order to exceed the applicati on limit. This worst-case scenario of 11.02 grams total pheromone applied thirteen times per year would equal an approxi mate daily application rate of 393 mg total pheromone/acre/day.

Compared to typical natural exposure, codling moths during the calling pe riod are estimated to release approximately 240 ng pheromone/hr (OECD, 2002), resulting in total pheromone release between 96 and 2,184 mg pheromone/acre/day. T hus, worst-case year-round application of

ISOMATE ® -DWB would be in the lower range of na tural release by a livi ng lepidopteran. And, given that the total level of dogw ood borer pheromone emitted by ISOMATE ® -DWB is comparable to naturally occurring emissions of pheromones during an in festation, the Agency concludes that it will have no impact on human health, non-target organisms, or the environment.(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 8 of 12 Biopesticides Registration Action Document

3. Food Quality Protection Act (FQPA) Consideration

a. Dietary Exposure and Ri sk Characterization

In accordance with 40 CFR 180.1153, SCLPs such as (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-ol are exempt from the requirement of a tolerance. Moreover, as

discussed in the human health asse ssment, the end-use product ISOMATE ® -DWB poses negligible toxicological hazard, including dietary h azard. Therefore, given the negligible dietary hazard and the limited possibility of dietary exposu re, we conclude that there will be very low risk associated with dietary exposure to ISOMATE ® -DWB. We note that this is consistent with the conclusion of the OECD, whic h 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 expos ure or residues are expected to result from the pesticidal usage of (E,Z)-2,13-octadecadien- 1-yl acetate and (E,Z)-2,13-oct adecadien-1-ol. These active ingredients are contained inside a closed polymeric tube dispen ser. The product will be applied to terrestrial areas only, and is not applied dire ctly to water, to areas where surface water is present, or to intertidal areas below the mean wa ter mark. Aerial applicati ons are not allowed. If

used in accordance with EPA- approved labeling, these active i ngredients are not likely to accumulate in drinking water. As a result, diet ary and drinking water exposure to residues of (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z )-2,13-octadecadien-1-ol are expected to be

minimal.

4. Occupational, Residential, School , and Day Care Exposure and Risk

Characterization

(E,Z)-2,13-Octadecadien-1-yl acetate and (E ,Z)-2,13-octadecadien-1-ol act via a non-toxic mode of action on a specific ta rget pest. The end-use product c ontaining these active ingredients is intended for agricultural use only (on food a nd ornamental crops). The expected exposure to humans and food/feed crops is low because the product is contained in a polymeric dispenser that is attached to tree limbs, and thus is not exp ected to come into direct contact with fruit or nuts. In addition, the potentia l for dermal, eye, and inha lation exposure to (E,Z)-2,13- octadecadien-1-yl acetate and (E,Z)-2,13-octadecad ien-1-ol 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 si gnal word and precautionary statements.

No outdoor or indoor residential, school, or day care uses ar e currently approved for products containing (E,Z)-2,13-octadecadien-1-yl acet ate and (E,Z)-2,13-oc tadecadien-1-ol.

5. 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,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-o l and other substances that have a common mechanism of toxicity. These consider ations include the possible cumulative effects of such residues on infants and children. (E,Z)-2,13-Octadecadien-1-yl acet ate and (E,Z)-2,13-octadecadien-1-ol have a

non-toxic mode of action and there is no indication or evidence to suggest that these biochemical(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 9 of 12 Biopesticides Registration Action Document

pesticides share a common mechanism of toxici ty with any other substance. Therefore, cumulative exposure concerns are not anticipated for the product ISOMATE ® -DWB.

6. Risk Characterization

(E,Z)-2,13-Octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-ol are synthetic

semiochemicals that act via a non- toxic mode of action on a specifi c insect pest. Given the low toxicity of lepidopteran pheromones in animal te sting, and the expected low exposure to humans, no risk to human health is expect ed from use of the product ISOMATE ® -DWB. The Agency has considered the various routes of exposure and po tential risks of the produc t and determined that the proposed use of the active ingredient does not pose significant ri sk to all populations, including infants and children.

C. Environmental Assessment

1. Ecological Effects and Hazards Assessment

According to 40 CFR 158.2060 (a)(2), SCLPs app lied up to a maximum use rate of 150 grams active ingredient/acre/year, and th at are not expected to be ava ilable to avian species, are not required to address non-target t oxicity data requirements. (E,Z )-2,13-Octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-o l are synthetic pheromones s ubject to 40 CFR 158.2060(a)(2), which acts on a select group of insect s and has a non-toxic mode of action.

2. Environmental Fate and Ground Water Data

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

3. Ecological Exposure and Ri sk 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,Z)-2,13- Octadecadien-1-yl acetate and (E ,Z)-2,13-octadecadien-1-ol are synthetic pheromone subject to 40 CFR 158.2060(a)(2), which acts on a select gr oup of insects and has a non-toxic mode of

action.

4. Endangered Species Assessment

Granted that (E,Z)-2,13-octadecadi en-1-yl acetate and (E,Z)-2,13-oc tadecadien-1-ol are not toxic to non-target organisms, the Agency has determ ined that they will have "No Effect" on any currently listed threatened or endangered species, or on any designated critical habitat.

D. Product Performance Data (Efficacy)

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 occur as a result of the use of ineffective products . The Agency reserves the right to require on a(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 10 of 12 Biopesticides Registration Action Document

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 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. For further guidance, please refer to Pesticide Registration Notice 96-7 ( http://www.epa.gov/PR _Notices/pr1996-7.pdf ), ( http://www.ea.gov/PR_Notices/pr2002-1.pdf ) and ( http://www.epa.gov/pesticid es/health/risk-benefit.htm ).

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 is such as to warrant the proposed claims for it; (B) its labeling and other materials required to be subm itted comply with the requirements of FIFRA; (C) it will perform its intended function w ithout unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.

These four criteria of the eligibility determina tion for pesticidal active ingredients are satisfied by the science assessments evaluating the subject registration applicati on for products containing (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2, 13-octadecadien-1-ol. Such products are not expected to cause unreasonable a dverse effects on the environmen t, and are likely to provide protection as claimed when used according to label instructions. Therefore, (E,Z)-2,13- octadecadien-1-yl acetate and (E,Z)-2,13-octadecadie n-1-ol are eligible for registration for the

labeled uses.

B. Regulatory Decision

At this time, EPA believes that the data submitted fulfill the requirements of registration for products containing (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-ol for use as mating disrupters of the dogwood borer at a rate not to exceed 3.5 grams active ingredient (AI)/1,000 square feet/year (equiva lent of 150 grams AI/acre/year). EPA has determined that (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2 ,13-octadecadien-1-ol present no issues of toxicological, ecological, or environmental con cern, will not cause harm to humans and will not

cause unreasonable adverse effects on the enviro nment. EPA has no concerns for any non-target organisms exposed to (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-ol in accordance with their approved uses. EPA has not identified any meaningful toxic endpoints for non-target mammals, birds, plants, aquatic, or soil organisms; nor are there concerns for any threatened and endangered species. Given the n on-toxic nature of (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-ol, EPA intends to issue registrations for these biochemical pesticides under Section 3(c)(5) of the Federal Insect icide, Fungicide, and Rodenticide Act (FIFRA).

Acute toxicity data for SCLPs, as discussed above, indicate that they be characterized as toxicity category III or IV. The end-use product will be characterized as toxicity category III.

ISOMATE ® -DWB does not demonstrate subchronic or developmental toxicity, and it is not mutagenic or genotoxic. EPA has no concerns for any non-target organisms exposed to(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 11 of 12 Biopesticides Registration Action Document

ISOMATE ® -DWB in accordance with approved label di rections. EPA has not identified any toxic endpoints for non-target mammals, birds, pl ants, aquatic, or soil organisms. There are no concerns for any threatened or endangere d species. Thus, given that ISOMATE ® -DWB has very low toxicity and presents little, if any, risk to non-target organisms, EPA concludes that it is in the public interest to issue the registration for ISOMATE ® -DWB.

C. Environmental Justice

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical or unusually high exposure to (E,Z )-2,13-octadecadien-1-yl acetate and (E,Z)-2,13- octadecadien-1-ol, compared to the general pop ulation. Please comment if you are aware of any sub-populations that may have atypical or unusua lly high exposure as co mpared to the general population.

VI. ACTIONS REQUIRED BY REGISTRANTS

The Agency has evaluated all data submitted in c onnection with the initial registration of (E,Z)- 2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octadeca dien-1-ol and determined that these data are sufficient to satisfy current registration data requirements. No additional data are required to be submitted to the Agency at this time. For new uses and/or changes to existing uses, additional data may be required.

Notwithstanding the information stated in the pr evious paragraph, it should be clearly understood that certain, specific, data are required to be reported to th e Agency as a requirement for maintaining the Federal registration for a pestic ide product. A brief summary of these types of

data are listed below.

A. Reporting of Adverse Effects

Reports of all incidents of adverse effects to the environment must be submitted to the Agency under the provisions stated in FIFRA, Section 6(a)(2).

B. Reporting of Hypersensitivity Incidents

Additionally, all incidents of 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).(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 12 of 12 Biopesticides Registration Action Document

VII. APPENDIX A: References

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

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

Zhang, A., Leskey, T.C., Bergh, J.C., and J.F. Walgenbach. (2005) Sex Pheromone of the Dogwood Borer, Synanthedon scitula . Journal of Chemical Ecology, 31(10): 2463-2479.