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

August 23, 2011

This document is for informational purposes only and is representative of the Agency’s justification in registering products containing this active ingred ient. 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-octadecadien -1-yl acetate and (E,Z)- 2,13-octadecadien-1-ol are technical grade synthetic Straight-Chain Lepido pteran Pheromones (SCLPs). These pheromones are structurally similar to, and mimic, naturally occurring pheromones produced by the female dogwood borer, Synanthedon scitula , to attract males for mating. Thes e 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 no rmal mating cycle of this pest in pome fruit, 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 contai ning the end-use product fo rmulation and the other containing a wire. The wire allows th e entire dispenser to be twisted around the branches of a tree. The product will only be dispensed in this manner. The product will not be applied through any type of irritation system. The product will be applied in the spring before dogwood borer adult emergence.

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

ornamental trees in the eastern Un ited States and Canada (Zhang et al., 2005). The larvae feed on the inner bark of live, healthy trees. Th e damaged area of the trunk or branch swells and eventually the bark will fall off; infested branches and limbs will die. D ogwood borers often will not ki ll the tree in the first year, but reinfestation in successive years will generally kill the tree. The end-use product (EP)

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, respectivel y, is intended to disrupt the mating of the dogwood borer, therefore decreasing the number of la rvae 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 from the requirement of a to lerance 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, EP A’s regulations at 40 CFR 158.2050(a)(2) and 158.2060(a)(2) exempt SCLP manuf acturing-use products from huma n health and environmental toxicology data requirements. Thes e data were waived based on the criteria presented in the OECD publication - Guidance for Registration Requirement s for Pheromones and Other Semiochemicals Used for Pest Control (OCED, 2002; http://www.epa.gov/pesticides/bi opesticides/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 exposur e to humans. Furthermore, adverse effects to nontarget organisms are not expected because pheromone s are released in very small quantities in the environment and act on a select group of insects. Thus, given that these co mpounds present both low hazard and low exposure, the Agency has determined th at, 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 and (E,Z)-2,13-octadeca dien-1-ol, synthetic SCLPs of the female dogwood borer, Synanthedon scitula . Product chemistry data requirements for the EP,

ISOMATE ® DWB, were satisfied by acceptable guideline st udies. Data waiver rationale submitted to

address human health and environm ental toxicology data requirements for the EP is 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

On October 1, 2009, EPA announced a new policy to pr ovide a more meaningful opportunity for the public to participate in major regi stration decisions before they occu r. According to this new policy, EPA intends to provide a public comment period pr ior to making a registration decision for, at minimum, the following types of applications: new ac tive ingredients, first food use, first outdoor use, first residential use, or actions for which EP A anticipates significan t public 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-octadecadie n-1-ol are subject to a 30-day comment period as “new active ingredient s,” the registration of which would result in a “first outdoor use, first food use,

and first residential use.” The intent of the 30-da y comment period is to provide a more meaningful opportunity for the public to particip ate in major registration decisions before they occur. The notice for this comment period includes the draft BRA D and the draft product label for ISOMATE ® DWB. The docket ID is EPA-HQ-OPP-2011-0247. No comments we re received in response to this notice. Therefore, the Agency is issuing the registrations fo r these active ingredients. The Agency believes that based on the risk assessment 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 th is decision can be found in th e risk assessment for (E,Z)-2,13- octadecadien-1-yl acetate 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 Corporation submitted an application for registration of enduse product (EP) Isomate ® DWB, containing the active ingredie nts (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octadecadi en-1-ol, at 5.46% and 0.27%, respectiv ely. A notice of receipt of the application for registration of (E,Z)-2,13-octadecadie n-1-yl acetate and (E,Z)- 2,13-octadecadien-1-ol as new active ingredients was published in the Fede ral Register on Wednesday, March 30, 2011 (76 FR 17644), with a 30-day comment perio d. No comments were received in response to this publication.

A. Classification

(E,Z)-2,13-Octadecadien-1-yl acetat e and (E,Z)-2,13-octadecadien-1-ol are synthetic Straight-chain Lepidopteran Pheromones and are classi fied as biochemical pesticides.

B. Food Clearance/Tolerances

SCLPs are exempt from the requirement of a tole rance in or on all raw ag ricultural commodities when applied to growing crops at a rate not to exceed 150 grams of active ingred ient/acre/year and in accordance with good agricultural use practices, and in i ndoor post-harvest treatment in or on all stored food commodities when applied/used at a rate no t 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). Pheromone s are ubiquitous in the environmen t, and are not considered to be air pollutants. During the season when moths and/or butte rflies appear, they normally emit pheromones and humans are naturally exposed to th ese pheromones without know ledge 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 acetat e and (E,Z)-2,13-octadecadien-1-ol are technical grade synthetic straight-chain lepidopteran pheromones. These pher omones are structurally similar to, and mimic, naturally occurring pheromones produced by the female dogwood borer, Synanthedon scitula , to attract males for mating. EPA reviewed the applicant’ s data on the product fo rmulation, 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. A ll required physical and chemical characteristics were adequately 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/y ear) and expected exposure to humans is lo w. Adequate information and scientific rationales to address all toxicity requirements for this product were submitted by the applicant. SCLP’s are exempt from the requirement of a tolerance (4 0 CFR 180.1153); therefore, di etary exposure is not a concern. Additionally, there will be no purposeful exposure to human skin, and inhalation exposure is negligible. In summary, no risk to human hea lth is expected from the use of ISOMATE ® DWB.

2. Dose Response Assessment

ISOMATE ® DWB consists of two parallel polymeric t ubes fused together, one containing the end-use product formulation and the other cont aining a wire. The wire allows the entire dispenser to be twisted

around the branch of a tree. ISOMATE ® DWB contains the active ingred ients (E,Z)-2,13-octadecadien1-yl acetate and (E,Z)-2,13-octa decadien-1-ol at 5.46% and 0.27%, respectively. The product also contains two other synthetic dogwoo d borer pheromones that were pr eviously registered with the Agency. The application use rate on the product label cons iders the total sum of all four of these pheromones and sets a total allowabl e application rate of 200 dispensers per ac re, or 11.02 grams total pheromone, per application. Application must not ex ceed 150 grams of total pheromone/acre/year. Thus, if applying at maximum label rate during each applic ation, the applicator woul d need to apply at a frequency greater than thirteen time s per year in order to exceed the application limit. This worst-case scenario of 11.02 grams total pherom one applied thirteen times per ye ar would equal an approximate daily application rate of 393 mg total phe romone/acre/day.

Compared to typical natural exposure, codling moth s during the calling period ar e estimated to release approximately 240 ng pheromone/hr (OECD, 2002), re sulting in total pherom one release between 96 and 2,184 mg pheromone/acre/day. Thus, worst- case year-round application of ISOMATE ® DWB would be in the lower range of natu ral release by a living le pidopteran. And, given th at the total level of dogwood borer pheromone emitted by ISOMATE ® DWB is comparable to naturally occurring emissions of pheromones during an infestation, the Agency conclude s 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 assessment, the end-use product ISOMATE ® DWB poses negligible toxicological hazard, including dietary hazard. Therefore, given the neglig ible dietary hazard and the limited possibility of dietary exposure, we conclude that there will be very low risk a ssociated with dietary exposure to

ISOMATE ® DWB. We note 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 resu lt from the pesticidal usage of (E,Z)-2,13-octadecadien-1-yl acetat e and (E,Z)-2,13-octad ecadien-1-ol. These ac tive ingredients are contained inside a closed polymeric tube dispenser. The product will be applied to terr estrial 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, these active ingredients are not likely to accumu late in drinking water. As a result, dietary and drinking water exposure to residues of (E,Z )-2,13-octadecadien-1-yl acetate and (E,Z)-2,13- octadecadien-1-ol are exp ected to be minimal.

4. Occupational, Residential, School, and D ay Care Exposure and Risk Characterization

(E,Z)-2,13-Octadecadien-1-yl acetat e and (E,Z)-2,13-octadecadien-1-ol act via a non-toxic mode of action on a specific target pest. The end-use product containing these acti ve ingredients is intended for agricultural use only (on food and or namental crops). The expected e xposure to humans and food/feed crops is low because the product is c ontained in a polymeric dispenser that is attached to tree limbs, and thus is not expected to come into direct contact with fru it or nuts. In addition, the potential for dermal, eye, and inhalation exposure to (E,Z)-2,13-octade cadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-ol for handlers is minimal due to the nature of the disp enser. The Agency also requires labels for products containing this active ingredient to include the a ppropriate signal word and precautionary statements.

No outdoor or indoor resident ial, school, or day care uses are cu rrently approved for products containing (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13-octa decadien-1-ol.

5. Cumulative Effects

Section 408(b)(2)(D)(v) of the Federal Food, Drug, a nd 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-ol and other substances that ha ve a common mechanism of toxicity. These considerations include the possible cumulative eff ects of such residues on infants and children. (E,Z)- 2,13-Octadecadien-1-yl acetate and (E ,Z)-2,13-octadecadien-1-ol have a non-toxic mode of action and there is no indication or evidence to suggest th at these biochemical pe sticides share a common mechanism of toxicity with any other substance. Therefore, cumulative e xposure concerns are not anticipated for the product ISOMATE ® DWB.(E,Z)-2,13-Octadecadien-1-yl Acetate and (E ,Z)-2,13-Octadecadien-1-ol Page 9 of 12 Biopesticides Registration Action Document

6. Risk Characterization

(E,Z)-2,13-Octadecadien-1-yl acetat e and (E,Z)-2,13-octadecadien-1-ol are synthetic semiochemicals that act via a non-toxic mode of action on a specific in sect pest. Given the low toxicity of lepidopteran pheromones in animal testing, and the expected low exposure to humans, no risk to human health is expected from use of the product ISOMATE ® DWB. The Agency has consid ered the various routes of exposure and potential risks of the product and determined that the propos ed use of the active ingredient does not pose significant risk to all p opulations, including infants and children.

C. Environmental Assessment

1. Ecological Effects and Hazards Assessment

According to 40 CFR 158.2060 (a)(2), SCLPs applied up to a maximum use rate of 150 grams active ingredient/acre/year, and that are not expected to be available to avian spec ies, are not required to address non-target toxicity data requirements. (E,Z)-2,13-Octadecadien-1-yl acetate and (E,Z)-2,13- octadecadien-1-ol are synthetic pheromones subj ect to 40 CFR 158.2060(a)(2), which acts on a select group of insects and has a non-toxic mode of action.

2. Environmental Fate and Ground Water Data

Environmental fate data are not required for this activ e ingredient because it is an SCLP being applied at a maximum use rate of 150 grams active ingredient/acre/y ear 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 envi ronmental fate data are not required because the active ingredient is an SCLP being app lied at a maximum use rate of 150 grams active ingredient/acre/year and is not ex pected to be available to avian species. (E,Z)-2,13-Octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-1-ol are synt hetic pheromone subject to 40 CFR 158.2060(a)(2), which acts on a select group of insect s and has a non-toxic mode of action.

4. Endangered Species Assessment

Granted that (E,Z)-2,13-octadecadien -1-yl acetate and (E,Z)-2,13-octade cadien-1-ol are not toxic to nontarget organisms, the Agency has determined 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 all pesticides to ensure that pesticide products 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 Agen cy reserves the right to require on a case-by-case basis, submission of efficacy data for any pesticide product registered or propos ed for registration that

are intended to be used to control a pest of significance public health im portance 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 Noti ce (PR) Notices 96-7, 2002-1 and Explanation of(E,Z)-2,13-Octadecadien-1-yl Acetate and (E,Z )-2,13-Octadecadien-1-ol Page 10 of 12 Biopesticides Registration Action Document

Statutory Framework for Risk-Benefit Balancing for P ublic 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/pest icides/health/riskbenefit.htm ).

V. RISK MANAGEMENT DECISION

A. Determination of Eligibility for Registration

Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is determined that (A) its composition is such as to warrant the propos ed claims for it; (B) its labeling and other materials required to be submitted comply with the requirem ents of FIFRA; (C) it will perform its intended

function without unreasonable adverse effects on th e environment; and (D) when used in accordance with widespread and commonly r ecognized practice it will not genera lly cause unreasonable adverse

effects on the environment.

These four criteria of the eligibility determination for pesticidal active ingredients are satisfied by the science assessments evaluating the subject registration ap plication 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 adverse effects on the e nvironment, and are likely to provi de protection as claimed when used according to label instructi ons. Therefore, (E,Z)-2,13-octadeca dien-1-yl acetate and (E,Z)-2,13- octadecadien-1-ol are eligible for re gistration 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-octad ecadien-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 (equivalent 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 toxicologica l, ecological, or environmental concern, will not cause harm to humans and will not cause unreasonable adverse effects on the environment. 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 non-toxic nature of (E,Z)-2,13-octadecadien-1-yl acetate and (E,Z)-2,13- octadecadien-1-ol, EPA is issuing registrations for these biochemical pesticides under Section 3(c )(5) of the Federal Insecticide, 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 pr oduct 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 ISOMATE ® DWB in accordance with approved label directions. EPA has not identified any toxic endpoints for non-target mammals, birds, plants, aquatic, or soil organisms. There are no concerns for any thre atened or endangered species. Thus, given that ISOMATE ® DWB has very low toxicity and presen ts little, if any, risk to non-target organisms, EPA concludes that it is in the public interest to issue the registration for ISOMATE ® DWB.(E,Z)-2,13-Octadecadien-1-yl Acetate and (E,Z )-2,13-Octadecadien-1-ol Page 11 of 12 Biopesticides Registration Action Document

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 origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural pr actices, 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 population. Please comment if you are aw are of any sub-populations that may have atypical or unusually high exposure as compared to the general population.

VI. ACTIONS REQUIRED BY REGISTRANTS

The Agency has evaluated all data submitted in conn ection with the initial re gistration of (E,Z)-2,13- octadecadien-1-yl acetate and (E,Z)-2,13-octadecadien-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 da ta may be required.

Notwithstanding the information stated in the previ ous paragraph, it should be clearly understood that certain, specific, data are required to be reported to the Agency as a requirement for maintaining the Federal registration for a pesticide pr oduct. A brief summary of these type s of data are listed below.

A. Reporting of Adverse Effects

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

B. Reporting of Hypersensitivity Incidents

Additionally, all incidents of hypers ensitivity (including both suspected and confirmed incidents) must be reported to the Agency under th e 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 for Arthropod Pest C ontrol. Organization for Economic Cooperation and Development (OECD). 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.