BIOPESTICIDES REGISTRATION ACTION DOCUMENT



## (Z,Z,E)-7,11,13-Hexadecatrienal

PC Code 029000

CITRUS LEAFMINER

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

(Last updated March 15, 2010)

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.(Z,Z,E)-7,11,13-Hexadecatrienal 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 Respon se Assessment .................................................................................................... .......................7 3. Food Quality Protection Act (FQPA) Consideration ............................................................................ .....8 4. Occupational, Residential, School and Day Care Exposure and Risk Characterization ........................8

5. Cumulative Effects .......................................................................................................... ..............................9

6. Risk Char acteriza tion ....................................................................................................... ............................9

C. Environmental Assessment ................................................................................................. 9

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

2. Environmental Fate and Ground Wa ter Data.................................................................................... ......10 3. Ecological Exposure an d Risk Characterization ............................................................................... .......10 4. Endangered Speci es Assessment ............................................................................................... .................10

D. Product Performance Data (Efficacy).............................................................................. 10

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

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

B. Regulatory Decision........................................................................................................... 1 1

C. Environmental Justice....................................................................................................... 11

VI. ACTIONS REQUIRED BY REGISTRANTS.................................................................. 12

A. Reporting of Adverse Effects ............................................................................................ 12

B. Reporting of Hypersensitivity Incidents .......................................................................... 12

VII. APPENDIX A: References................................................................................................. 12(Z,Z,E)-7,11,13-Hexadecatrienal Page 3 of 12 Biopesticides Registration Action Document

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs:

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

Gina Casciano Biologi st / Regulatory Action Leader

Linda Hollis Branch Chief Colin Walsh Biologist(Z,Z,E)-7,11,13-Hexadecatrienal Page 4 of 12 Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY

The new active ingredient (Z,Z,E)-7,11,13-hexadecatri enal is a technical grade synthetic straightchain lepidopteran pheromone (SCLP). This phero mone is structurally similar to, and mimics, a naturally occurring pheromone produced by the female citrus leafminer moth (CLM), Phyllocnistis citrella , to attract males for mating. The synt hetic technical grad e active ingredient (TGAI) (Z,Z,E)-7,11,13-hexadecatriena l is intended to mitigate th e effects of CLM by disrupting the normal mating cycle of CLM on citrus crops. The pesticide product will be dispensed from a tube in small amounts, such as droplets or do llops, either manually (i.e. spatula, caulking gun, back sprayer) or mechanically via tractor, all- terrain vehicle, aircraft , or other appropriate mechanical device. The product will not be app lied through any type of irritation system. Once applied, droplets will cure in 2-3 hours, after wh ich they become rain-fast and UV resistant, and will slowly release infinitesimal amounts of (Z,Z,E)-7,11,13-hexadecatrienal into the atmosphere. The droplet or dollop size can be varied (larger or smaller) depending on (1) the amount of active ingredient applied per acre (not to exceed 150 grams of active ingredient per acre) and (2) the duration of control required. A higher number of small droplets will emit more pheromone in a shorter time. Application will oc cur in the upper one- thir d of plant foliage or

tree canopy.

The citrus leafminer moth (CLM) Phyllocnistis citrella poses a risk of serious harm to citrus crops, particularly in areas wher e efforts to control “citrus gr eening” disease (also known as Huanglongbing or HLB), caused by an Asia n citrus psyllid vector carrying Candidatus Liberibacter asiaticus, has re sulted in increased CLM populati ons. As CLM larvae emerge on citrus trees, they feed on new flush (growth) creating shallow tunnels, or mines, on the leaf’s upper and lower surfaces. While CLM infestation al one is not often fatal to mature trees, the mines that it leaves greatly increase the susceptib ility of the plant to a th ird pest known as citrus canker ( Xanthomonas axonopodis ). The resulting infection lead s to blemished fruit, premature fruit drop, and tree decline. The end-use product SPLAT CLM TM , containing 0.15% of the active ingredient Z,Z,E)-7,11,13-hexadecatrienal, is intended to disrupt CLM mating, therefore decreasing the number of larvae to feed on plant leaves and, consequently, the susceptibility of

the fruit tree to citrus canker.

Pursuant to FIFRA Section 3(c)(4 ), EPA has provided notice of the receipt of an application to register the pesticides products ISCA CLM MP (manufacturing-use product), and SPLAT

CLM TM (end-use product), which contain the activ e ingredient (Z,Z,E,)-7,11,13-hexadecatrienal, a mating disruptor pheromone not in cluded in any previously regist ered pesticide products. The notice includes a profile of th e active ingredient and products. The docket ID is EPA-HQ-OPP2009-0930. The Agency did not receive any comments on this notice.

Product chemistry data requirements for both th e manufacturing-use prod uct (MP) and the enduse product (EP) were satisfied by acceptable gui deline studies. EPA’s regulations at 40 CFR 158.2050(a)(2) and 158.2060(a)(2) exempt SCLP MPs from human health and environmental toxicology data requirements. Data waiv ers submitted to address human health and environmental toxicology data requirements for the EP are acceptable. No risks to human health are expected from the use of lepidopteran pheromones based on demonstrated low toxicity in animal testing and expected low exposure to hu mans. Furthermore, adverse effects on 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(Z,Z,E)-7,11,13-Hexadecatrienal Page 5 of 12 Biopesticides Registration Action Document

present low risk to both humans and non-target organisms (and, in actuality, they present low toxicological risk to th e target organism).

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, and first residential use.

Consistent with the new policy of making regi stration actions more transparent, (Z,Z,E)-7,11,13- hexadecatrienal is subject to a 30-day comment period as a “new active ingredient,” the registration of which would result in a “first outdoor use, first food use, and first residential use.” While a final decision on registration is cont ingent upon review and consideration of public comments, the Agency presently believes that based on the preliminary risk assessment and information submitted in support of the registra tion of (Z,Z,E)-7,11,13-hexadecatrienal, it is in the best interest of the public and the environment to issue th e registration for this active ingredient. The basis for this preliminary de cision can be found in the risk assessment for (Z,Z,E)-7,11,13-hexadecatrienal, which is characterized in this BRAD.(Z,Z,E)-7,11,13-Hexadecatrienal Page 6 of 12 Biopesticides Registration Action Document

II. ACTIVE INGREDIENT OVERVIEW

Common Name: (Z,Z,E)-7,11,13- Hexadecatrienal

Chemical Name: (7Z,11Z,13E)-7,11,13-Hexadecatrienal

Trade & Other Names : Citrus Leafminer Lepidoptera Pheromone

CAS Registry Number: 888042-38-4

OPP Chemical Code: 029000

Type of Pesticide: Mating disrupter for citrus leafminer moth

III. REGULATORY BACKGROUND

On November 4, 2009, ISCA Technologies, Inc., submitted applications for registration of a manufacturing-use product (MP) ISCA CL M MP and end-use product (EP) SPLAT CLM TM

, containing the active ingredient (Z,Z,E )-7,11,13-hexadecatrienal at 66.5% and 0.15%, respectively. A notice of r eceipt of the appli cation for registration of (Z,Z,E)-7,11,13- hexadecatrienal as a new active ingredient was published in the Federal Register on January 27, 2010 (75 FR 4383), with a 30-day comment period. No comments were received in response to this publication.

Consistent with the new policy of making regi stration actions more transparent, (Z,Z,E)-7,11,13- hexadecatrienal is subject to a 30-day comment period as a “new active ingredient,” the registration of which would result in a “first outdoor use, first food use, and first residential use.” While a final decision on registration is cont ingent upon review and consideration of public comments, EPA presently believes that, base d on the preliminary risk assessment and information submitted in support of the registration of (Z,Z,E,)-hexadecatrienal, that it is in the best interest of the public and the environment to register (Z,Z,E)-hexadecatrienal. The basis for this preliminary decision can be found in the risk assessment for (Z,Z,E)-7,11,13- hexadecatrienal, which is characterized in this BRAD.

A. Classification

(Z,Z,E)-7,11,13-Hexadecatrienal is a synthetic St raight-chain Lepidopter an Pheromone (SCLP) and is classified as a biochemical pesticide.

B. Food Clearance/Tolerances

Straight-chain Lepidopteran Pheromones (SCLPs ) are exempt from the requirement of a tolerance in or on all raw agricu ltural commodities when applied to growing crops at a rate not to exceed 150 grams of active ingredient/acre/year and in accordance with good agricultural use practices, and in indoor post-harvest treatmen t in or on all stored food commodities when applied/used at a rate not to exceed 3.5 gram s active ingredient (AI)/1,000 square feet/year (equivalent of 150 grams AI/acre/ year), in accordance with good ag ricultural use practices (40 CFR 180.1153). Pheromones are ubiqu itous in the environment, and are not considered to be air(Z,Z,E)-7,11,13-Hexadecatrienal Page 7 of 12 Biopesticides Registration Action Document

pollutants. During the season, where moths a nd/or butterflies appear, they normally emit pheromones and, therefore, humans are natura lly exposed to these pheromones without knowledge and without a ny adverse reactions.

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

(Z,Z,E)-7,11,13-Hexadecatrienal is a technical grade synthetic straight-chain lepidopteran pheromone (SCLP). This pheromone is structura lly similar to, and mimics, a naturally occurring pheromone produced by the female citrus leafminer moth (CLM), Phyllocnistis citrella , to attract males for mating. The descriptions of the produc t formulation and production process, as well as the formation of impurities, were examined by the Agency and found to meet current standards. Packaging for these products was also adequately described and quality c ontrol/quality assurance procedures were adequately discussed. A cceptable results were provided regarding the preliminary analysis of five batches of each product. All required physical and chemical characteristics were adequately presented. A tw o-year storage stability study is ongoing and is expected to be completed in October, 2011.

B. Human Health Assessment

1. Toxicology Assessment

The end-use product SPLAT CLM TM 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. Label requirements indicate that the product must be applied while wearing a longsleeved shirt, long pants, socks, shoes, chemi cal resistant gloves, and protective eyewear. Additionally, since there will be no direct contact with food or fe ed crops, there is no chance to develop skin sensitiza tion through the oral route and inhala tion exposure is negligible. The inerts in this product are all cl eared for food-use and SCLP’s are exempt from the requirement of a tolerance. In summary, no risk to human h ealth is expected from the use of SPLAT CLM TM

.

2. Dose Response Assessment

SPLAT CLM TM is a paste containing 0.15% of the active ingredient (AI) (Z,Z,E)-7,11,13- hexadectrienal. The applicati on use rate allowed by the label is 10 grams to 10 kilograms of undiluted product per acre, which is equivalent to 0.015 to 15 grams of AI per acre. Application must not exceed 150 grams of (Z,Z,E)-7,11,13-hexa dectrienal per acre per year. Thus, if applying at maximum label amount during each application, the appl icator would need to apply at a frequentcy greater than ten times per year in order to exceed the application limit. This worst case scenario of 15 grams AI applied ten times per year w ould equate to an approximate daily application rate of 410 mg AI/acre/day.(Z,Z,E)-7,11,13-Hexadecatrienal Page 8 of 12 Biopesticides Registration Action Document

Comparing this to typical natural exposure, c odling moths during the cal ling period are estimated to release an approximate 240 ng pheromone/hr (OECD, 2002), ∗ resulting in total pheromone release between 96 and 2,184 mg pheromone/acre/ day (based on estimates of the density of codling moth females in severe outbreaks in orchards, between 17,000-380,000 females/acre). Thus, worst case year-round application of SPLAT CLM TM would be in the lower range of natural release by a living lepidopteran. Thus , given that the emission level of (Z,Z,E)-7,11,13-

hexadecatrienal in SPLAT CLM TM is comparable to naturally occurring emissions of pheromones during an infestation, the Agency co ncludes that it will ha ve no impact on human health, non-target organisms, or the environment.

3. Food Quality Protection Act (FQPA) Consideration

a. Dietary Exposure and Risk Characterization

In accordance with 40 CFR 180.1153, SCLPs such as (Z,Z,E)-7,11,13-hexadecatrienal are exempt from the requirement of a tolerance. Moreover, as discussed ab ove regarding the human health assessment, the end-use product SPLAT CLM TM poses negligible toxicological hazard, including dietary hazard. Therefore, given th e negligible dietary hazard and the limited possibility of dietary exposure, we conclude that there will be very low risk associated with dietary exposure to SPLAT CLM TM . 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; http://www.epa.gov/pesticides/bi opesticides/regtools/index.htm ). ∗

b. Drinking Water Exposure and Risk Characterization

No significant drinking water expos ure or residues are expected to result from the pesticidal usage of (Z,Z,E)-7,11,13-hexadecatrienal. The activ e ingredient (a.i) is intended for use as a droplet or dollop. It will be appl ied to terrestrial areas only, and is not applied directly to water, to areas where surface water is present, or to in tertidal areas below the mean water mark. Aerial applications are allowed. If droplets of a.i. from aerial application hit surface water, minimal concern to drinking water would exis t due to the demonstrated low toxi city of SCLPs. If used in accordance with EPA-approved labeling, the a.i. is not likely to accumulate in drinking water. As a result, dietary and dri nking water exposure to residues of (Z,Z,E)-7,11,13-hexadecatrienal are expected to be minimal.

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

Characterization

(Z,Z,E)-7,11,13-Hexadecatrienal act s via a non-toxic mode of acti on on a specific target pest. The end-use product containing th is active ingredient is inte nded for both agricultural and residential use. In agricultural use, the expect ed exposure to humans a nd food/feed crops is low because the product is applied early, and thus is not expected to come into contact with fruit or nuts that develop later in the season. In addi tion, the potential for dermal, eye, and inhalation exposure to (Z,Z,E,)-7,11,13-hexadecatrienal fo r handlers is minimal and will be further mitigated if products are used according to la bel directions, which require the use of long-

∗ Series on Pesticides No. 12: Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control. Organization for Ec onomic Cooperation and Development (OECD). Issued: 02/26/2002. Available at: http://www.epa.gov/pe sticides/biopesticides/regtools/index.htm(Z,Z,E)-7,11,13-Hexadecatrienal Page 9 of 12 Biopesticides Registration Action Document

sleeved shirt and long pants, socks, shoes, chem ical resistant gloves, and protective eyewear. The Agency also requires labels for products co ntaining this active ingredient to include the appropriate signal word, re-entry inte rval, and precautionary statements.

Outdoor residential use is expect ed, but the potential for dermal, eye, and inhalation exposure to (Z,Z,E,)-7,11,13-hexadecatrienal for handlers is mi nimal and will be further mitigated if products are used according to label direct ions (see above). No indoor re sidential, school, or day care uses currently appear on the label for this or any other SCLP. Alt hough possible accidental nondietary exposure at sites where children are present (residential or, perhaps, agricultural) may occur, the health risk is expected to be mini mal based on low mammalian toxicity. No risk to those in occupational, residentia l, school, or day care exposure gr oups is expected from the use of this active ingredient in accordance with EPA accepted labeling.

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 (Z,Z,E)-7,11,13-hexadecatrienal and to

other substances that have a co mmon mechanism of toxicity. Th ese considerations include the possible cumulative effects of su ch residues on infants and child ren. Due to the fact that (Z,Z,E)-7,11,13-hexadecatrienal has a non-toxic mode of action, there is no indication or evidence to suggest that this biochemical pestic ide shares a common mechanism of toxicity with any other substance. Cumulative ex posure concerns are not anticipated.

6. Risk Characterization

(Z,Z,E,)-7,11,13-Hexadecatrienal is a synthetic se miochemical that acts via a non-toxic mode of action on a specific insect pest. Given the low toxicity of lepidopteran pheromones in animal testing, and the expected low exposure to humans, no risk to human health is expected from use of the product SPLAT CLM TM . The Agency has considered the various routes of exposure and potential risks of the product and determined th at the proposed use of the active ingredient does not pose significant risk to all popula tions, including infa nts 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 maximun 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. (Z ,Z,E)-7,11,13-Hexadecatrienal is a synthetic pheromone subject to 180.2060(a)(2), which acts on a sele ct group of insects and has a

non-toxic mode of action.(Z,Z,E)-7,11,13-Hexadecatrienal Page 10 of 12 Biopesticides Registration Action Document

2. Environmental Fate and Ground Water Data

Environmental fate data are not required for this active ingredient because it is an SCLP being applied at a maximum use rate of 150 grams active ingredient/acre/year a nd is not expected to available to avian species (40 CFR 158.2060).

3. Ecological Exposure and Ri sk Characterization

According to 40 CFR 158.2060 (a) (2), environmen tal data are not required because the active ingredient is an SCLP be ing applied at a maximum use rate of 150 grams active ingredient/acre/year and is not expected to available to avia n species. (Z,Z,E)-7,11,13- Hexadecatrienal is a synthetic pheromone subj ect to 180.2060(a)(2), which acts on a select group

of insects and has a non-toxic mode of action.

4. Endangered Species Assessment

Based on the fact that (Z,Z,E)-7,11,13-hexadecatrienal is not toxic to non-t arget organisms, the Agency has determined it will have "No Effect" on any currently listed threatened or endangered species, or on any design ated critical habitat

D. Product Performance Data (Efficacy)

Submission of product performance data (OPPTS 810.3000) is listed as a requirement for all pesticide products. Customarily, the Agency requ ires efficacy data to be submitted for review only in connection with the registration of produc ts directly pertaining to the mitigation of disease bearing human health organisms and cer tain designated quarantine pests, i.g., ticks, mosquitoes, fleas, Mediterranean fruit flies, gypsy moths, Japane se beetles. For a list of organisms considered by the Agency as “publ ic health pests”, please refer to Pesticide Registration Notice 2002-1 ( http://www.epa.gov/PR_Notices/pr2002-1.pdf ).

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.

The four criteria of the Eligibility Determinati on for Pesticidal Active Ingredients are satisfied by

the science assessments evaluati ng the subject registration app lication for products containing (Z,Z,E)-7,11,13-hexadecatrienal. Such products ar e not expected to cause unreasonable adverse effects on the environment, and are likely to provide protection as claimed when used according to label instructions. Therefore, (Z,Z,E)-7,11,13-he xadecatrienal is eligible for registration for

the labeled uses.(Z,Z,E)-7,11,13-Hexadecatrienal Page 11 of 12 Biopesticides Registration Action Document

B. Regulatory Decision

As set forth above, EPA has determined that (Z,Z,E)-7,11,13-hexadecatrienal presents no issues of toxicological, ecological, or environmental concern, and will not cause harm to humans and

will not cause unreasonable adverse effects on th e environment. Thus, given that (Z,Z,E)- 7,11,13-hexadecatrienal has very low toxicity and presents little if any risk to non-target organisms, EPA concludes that it is in the best interest of the public and the environment to issue the registration for this biochemical pestic ide. On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for the public to comment on major registration

decisions in advance of EPA's final decision. 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 applications: new active ingredients; first f ood use; first outdoor use; first residential use; and any regist ration decision for which the Agency believes there may be substantial public interest.

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. SPLAT

CLM TM does not demonstrate subchronic or developm ental toxicity, and it is not mutagenic or genotoxic. EPA has no concerns for any non- target organisms exposed to SPLAT CLM TM in accordance with approved label directions. EP A has not identified any toxic endpoints for nontarget mammals, birds, plants, aquatic, or soil organisms. There are no concerns for any threatened or endangered species . Thus, given that SPLAT CLM TM has very low toxicity and presents little, if any, risk to non-target organisms, EP A concludes that it is in the best interests of the public and the environment to issue the registration for SPLAT CLM TM

.

Consistent with the Agency’s new policy for maki ng these registration actions more transparent, EPA is providing a 30-day public comment period on the regi stration of manufacturing-use product ISCA CLM MP and end-use product SPLAT CM TM , both containing the new active ingredient (Z,Z,E)-7,11,13-hexadecat rienal. The intent of the 30-day comment period is to provide a more meaningful opportunity for the public to participate on major registration decisions before they occur. All comments w ill be included in the docket (EPA-HQ-OPP-2009- 0930) as they are received.

At this time, EPA believes that the data submitted fulfill the requirements of registration for products containing (Z,Z,E)-7,11,13-he xadecatrienal for use as a mating disrupter of the citrus leafminer moth at a rate not exceeding 150 gram s / acre / year. EPA has no concerns for any non-target organisms exposed to (Z,Z,E)-7,11,13- hexadecatrienal in accordance with its approved uses. EPA has not identified any mean ingful 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 char acter of (Z,Z,E)-7,11,13-hexadecatrienal, EPA supports its registration under S ection 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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(Z,Z,E)-7,11,13-Hexadecatrienal Page 12 of 12 Biopesticides Registration Action Document

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, unusually high exposure to (Z,Z,E)- 7,11,13-hexadecatrienal, comp ared to the general population. Please comment if you ar e aware of any sub-populations that may have atypical, unusually high exposure as compared to the general population.

VI. ACTIONS REQUIRED BY REGISTRANTS

The Agency has evaluated all data submitted in connection with the initial registration of (Z,Z,E)-7,11,13-hexadecatrienal 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.

Not withstanding the information stated in th e previous paragraph, it should be clearly understood that certain, specific, da ta are required to be reported to the Agency as a requirement for maintaining the Federal regi stration for a pesticide 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

All incidents of hypersensitivity (including both suspected and confirmed incidents) must be reported to the Agency under the pr ovisions of 40 CFR Part 158.2050(d).

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