UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C

. 20460 

## SiP 07 2DU

MEMORANDUM OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

SUBJECT: BEAD Chemical Profile for Registration Review: Spinetoram (110008 and 110009) FROM:

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TO: DavidBrassard, Entomologist Biological Analysis Branch Jihad Alsadek, Economist

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# A-UJ..ek Science Information and Analysis Branch "
. Derek Berwald,

# ~onomist**~** I(J

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# J. EconoInlc AnalYSIS Branch

## ~~ Biological and Economic Analysis Division (7503P) Arnet Jones, Chief 

# /.7 ""-.,**~** Biological Analysis Branch

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Diann Sims, Chief

# ~ Science Information and Analysis Branch Timothy Kiely, Chief

# ~**~** Economic Analysis Branch Biological and Economic Analysi Division ( ) Wilhelmena Livingston, Chemical Review Manager Anne Overstreet, Team Leader Risk Management and Implementation Branch 3 Pesticide Reevaluation Division (7508P)
Product Review Panel date: August 31, 2011 INTRODUCTION The purpose ofthis document is to convey usage information and a broad overview ofthe pest management roles ofpesticides that are beginning to undergo registration review. The anticipated audience consists ofthe team ofEPA staffcurrently evaluating the registration status 1ofSpinetoram (110008 and 110009), and eventually the general public. This document builds upon**t~e** data already provided in the "Usage and Label Use DataPackages" that are also providedto Registration Reviewteams by BEAD. The document is based oninformation and data available to BEAD as ofAugust 24, 2011. Spinetoram is a fermentation byproduct ofSaccharopolyspora spinosa and an analogue of spinosad. Spinetoram is a mixture oftwo closely related active ingredients, spinetoram-Jand spinetoram-L, present in an approximate 3: 1ratio. Manufacture ofspinetoram occurs intwo major steps. The first step involves fermentation production ofspinosyn J and spinosyn L. In the second step, these fermentation products are chemically modified to yield spinetoram-J and spinetoram-L. These chemical alterations to the spinosyn structure are believed to broadenthe spectrum ofpests controlled and extendthe period ofresidual activity ofspinetoram relative to spinosad (Racke et al., 2011). Spinetoram was first registered in the U.S. in 2007. Spinetoram is a broad-spectrum insecticide that kills insects via contact with the insect cuticle and/or dietary exposure. Insecticides exhibiting these routes ofexposure leading to lethality were historically described as contact and stomachpoisons. Spinetoram's insecticidal mode ofaction is attributed to allosteric modulation ofthe insect's nicotinic acetylcholine receptors. This interaction generates an acetylcholineinduced inward current that causes widespread neuronal excitationresulting in involuntary muscle contractions, tremors, and eventually death. (EPA 2009, Racke et aI., 2011) Spinetoram is effective in controlling lepidopterous pests, Colorado potato beetles, serpentine leafminers, fleas, fruit flies, fire ants, sawfly larvae, andthrips (EPA, 2009; NPIRS, 2011). Spinetoram is not permittedfor use in organic agricultural production because its molecular structure has been synthetically altered. USE SITES Agricultural Use Sites Spinetoram is registered for use on asparagus, banana andplantain, brassica crops, bulb vegetables, cereal grains (barley, oats, rice, rye, sorghum, triticale, and wheat ), citrus, com (field, sweet, popcorn, and seed com), cotton, cucurbits, dates, fig, fruiting vegetables (tomato, peppers, and eggplant), globe artichoke, grain amaranth, herbs, hops, leafy vegetables, leaves of legume vegetables, leaves ofroot andtuber vegetables, legume vegetables (succulent and dried beans and peas), okra, peanut, peppermint, pineapple, pistachios, pome fruits, pomegranate, root and tubervegetables, root vegetables, small fruits (bushberries, caneberries, cranberry, grapes, strawberry) soybean, spearmint, spice crops (exceptblackpepper), stone fruits, teosinte, tree nuts, tropical tree fruits, turnip greens and watercress. Non-Agricultural Use Sites Spinetoram is registered for use on ornamentals (herbaceous plants, lawns and turf, shrubs, vines, and trees), and cats (spot ontreatment).
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### COMMON FORMULATIONS AND APPLICATION METHODS Spinetoram is formulated as ready-to-use solution, dispersible granules and as soluble and emulsifiable concentrates. 

### USAGE Agricultural Based on private marketpesticide usage data from 2007-2010, the annual total agricultural usage averaged approximately 46,000 pounds active ingredient for 700,000 acres for an overall average of0.07 lbs. a.i. applicationrate per acre. In comparison to this rate, the average application rate in lbs. a.i. per acre is 0.09 for apples, 0.04 for lettuce, and 0.08 for oranges. From 2007-2010, the largest markets interms oftotal pounds ofactive ingredient applied are: apples (29%), oranges (14%), and lettuce (13%). The crops with the highest total areatreated (TAT) are apples (22%), lettuce (20%), and oranges (12%). The states with the most agricultural usage in terms ofpounds a.i. applied are California (36%), Washington (22%), and Florida (17%) (Proprietary Data, 2007-2010). 

### USE TRENDS Figure 1provides usage trends, in terms ofpounds applied, for spinetoram's largest agricultural markets. There was very little use ofspinetoram in 2007. Use on apples and lettuce did not change much during 2008-2010. The use ofspinetoram on oranges and other crops increased during this period. The data provided in this section is provided for preliminary scoping purposes only, because the datahave not been analyzed. Figure 1. S 

### inetoram Usa e Data 80,000 

## "T"-------------

PoundsA.I. • Other Crops
• Oranges
• Lettuce • Apples 

### o +----,--' 2007 2008 2009 2010 Years

Other crops include: apricots, artichoke, asparagus, beans, broccoli, cabbage, caneberries, cantaloupes, carrots, cauliflower, celery, cherries, cotton, cucumbers, grapefruit, grapes, onions, peaches, pears, pecans, peppers, plums/prune, potatoes, pumpkin, soybeans, spinach, squash, strawberries, sweet com, tomatoes, walnuts, and watermelons. Source: Proprietary Data, 2007-2010



### 3Dow anticipates that the use ofspinetoram will continue to increase and displace spinosad uses due to its enhanced biological activity relative to spinosad (Racke et aI., 2011). BIOLOGICAL ASPECTS RELEVANT TO SPINETORAM According to the Arthropod Pesticide Resistance Database (APRD, 2011), there have been no reports ofinsectresistance to spinetoram. The Arthropod Pesticide Resistance Database does contain 14 reports ofresistance on 6 insect pest species on 13 crops for spinosad, an analogue of spinetoram. Since the two active ingredients are inthe same chemical class and are closely related structurally, there is a high probabilitythat there is some cross-resistance between spinosad and spinetoram. The 6 insect pests involved have beenreported to beresistant to many pesticides. These findings, coupled with spinetoram's unique mode ofaction, suggest that spinetoram may be an important componept inintegrated resistance managementprograms.
HISTORY OF BEAD ASSESSMENTS FOR SPINETORAM In 2006, the Canadian Pest Management Regulatory Agency (PMRA), reviewed 27 efficacy studies submittedbyDowAgroSciences in support ofnewuses against 20 insect pests. BEAD concurred withthe findings ofthe PMRA (Chiri, 2006). PMRAproposed acceptance ofthe proposed application rates withthe exception ofthree cases. In two cases, (thrips on onions and spanworm onblueberries), a lower application rate was recommended, and one use (Cabbage looper, imported cabbageworm, and diamondback moth on leafy (non-Brassica) vegetables) was not supported because itinvolved insects not generally found onthe proposed crop. DATA NEEDS RELEVANT TO BEAD'S FUTURE WORK ON SPINETORAM Obtaining additional information onthe following items would improve future BEAD assessments ofthe importance ofSpinetoram and may be required as part ofthe registration review ofthis pesticide.
• Usage information on animal treatment (cats) • Usage information on ornamental plants

4REFERENCES APRD. 2011. Arthropod Pesticide Resistance Database. Michigan state University. http://www.pesticideresistance.org/ Chiri, Angel. Secondary review ofPMRA-reviewed efficacy data for XDE-175, a spinosad analog, April 26, 2006. Dow. 2011. Spinosad Overview. DowAgroSciences LLC. http://www.dowagro.com/turf/prod/spinosad.htm EPA 2009. EPA fact Sheet for Spinetoram. http://www.epa.gov/ opprdOO 1/factsheets/spinetoram.pdf GfK Kynetec. 2007-2010. Proprietary Data. NPIRS. 2011. National Pesticide Infonnation and Retrieval System. http://npirs.ceris.purdue.edu Racke, K.D. et al. 2011. Spinosad and Spinetoram: Infonnationto Support EPA's Registration Review. DowAgroSciences LLC



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