UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D

.C

. 20460



### MEMORANDUM OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: BEAD Chemical Profile for Registration Review: Fenhexamid (090209) 

### FROM:

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TO: Carl Chen, Plant Pathologist Biological Analysis Branch Jihad Alsadek, Economist 

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# v4-/**A-~ -14~**  Science Information and Analysis Branch Andrew Lee, Economist 

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# ~ Economic Analysis Branch / r. 

### Biological and Economic Analysts Division (7503P) ArnetJones, Chief

### ~ Biological Analysis Branch Diann Sims, Chief

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## Informatio**rfati Analysis**  Branch Timothy Kiely, Chief

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# I~ Economic Analysis Branch 

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# t Biological and Economic Analysis ivision (75 Joel Wolf, Chemical Review Manager Risk Management and Implementation Branch 2 Pesticide Re-evaluation Division (7508P) 

### Product Review Panel date: October 24,2012 Revised Date: May 13, 2013 INTRODUCTION The purpose ofthis document is to convey usage information and a broad overview ofthepest management roles ofpesticides that are beginning to undergo registration review. The anticipated audience consists ofthe team ofEPA staffcurrently evaluating the registration status offenhexamid and eventually the general public. This document builds upon the data already
1provided inthe "Usage and Label Use DataPackages" that are also providedto Registration Reviewteams byBEAD. The document is based on information and data available to BEAD as ofOctober 2012. Fenhexamidbelongs to the chemical family ofhydroxyanilides functioning as a sterol biosynthesis inhibitor (SBI). This SBI Class III fungicide was registered in 1999 and has been mainly usedto control some importantplant diseases including

### Botrytis cinerea onblueberries, caneberries, cherries, grapes, peaches, pistachios, and strawberries. Fenhexamid is also registered for use ongreenhouse and nursery-grown ornamentals to control Botrytis and powdery mildewdiseases. 

### COMMON FORMULATIONS AND APPLICATION METHODS Fenhexamid is formulated as water dispersible granules. Theproductis applied as a foliar spray by ground equipment only, no aerial application. 

### USE SITES Agricultural Use Sites Fenhexamid is registered for use on almonds, asparagus, busberries, caneberries, cherry, cilantro, cucumber, flavoring/spice crops, fruiting vegetables, ginseng (medicinal), grapes, kiwi fruit, leafy vegetables (except spinach), pear, pistachio, pomegranate, raspberry (black and red), stone fruits, strawberry, and tomato. Non-Agricultural Use Sites Fenhexamid is registered for use onornamental and/or shade trees, ornamental herbaceous plants, ornamental non-flowering plants, and ornamental woody shrubs and vines. 

### USAGE Agricultural Usage Figures 1 shows the use offenhexamid interms oftotal pounds a.i. used during the period 1999- 2011. The initial registration for this chemical was in 1999. The use offenhexamid interms of lbs. a.i. applied increases throughout the whole period (1999-2011). The increase seems to be steady withthe exception ofsome down years in 2007 and 2009.

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### Figure 1. 

### Agricultural Usage Datafor Fenhexamid in Pounds A.I. on all Crops (1999-2011) 160,000

0 en 0 .-I N M <:t IJl lO 

### ..... co en 0 .-I en 0 0 0 0 0 0 0 0 0 0 .-I ...... en 0 0 0 0 0 0 0 0 0 0 0 0 .-I N N N N N N N N N N N N Years All crops include apricots, caneberries, cherries, grapes (raisins, table, and wine), peaches, pistachios, plums/prunes, soybeans, and strawberries. Source: Proprietary Data, 1999 -2011 

### Figure 2 provides usage data for the crops withthe most usage, strawberries, wine andtable grapes from 2007-2011. The use offenhexamid on strawberries fluctuated between 2007 and 2011. The use onwine and table grapes, and onother crops was rising during the same time period, 2007-2011. 

### Fi 70,000**Strawberries**

--- Grapes, Wine -A- Grapes, Table**Other** 0
Years



### 3Other crops include caneberries (6%), raisin grapes (4%), and the rest ofthe crops (cherries, peaches, pistachios and soybeans (<I%). Source: Proprietary Data, 2007-2011 From 2007-2011, the annual total agricultural usage averaged approximately 90,000 pounds active ingredient (a.i.) for 170,000treated acres with an overall application rate of0.6 lbs. a.i. per acre. Table 1, for the same time frame (2007-2011), shows the crops withthe most use interms of total pounds ofactive ingredient applied and total acres treated (TAT) in acres. 

### Table 1. 

### Fenhexamid's Percent ofTop Crops in Terms ofLbs. Applied & 

### TAT in Acres (2007-2011) Crops

- -- - - -, % Pounds A lied % Total AreaTreated 

### Strawberries 41 34 33 37 16 17 

### Source: Proprietary Data, 2007-2011 On average, the states withthe most agricultural usage in terms ofpounds a.i. applied are California (86%), Florida (5%), and Washington (4%), (Proprietary Data, 2007-2011).


### Fenhexamid's Agricultural Usage by Crop Reporting District Another measure ofusage is the use intensity. Inthis analysis, the use intensity is expressed as the pounds a.i. applied per 1,000 acres ofland in farms. This differs from the applicationrate, which is expressed as the pounds a.i. appliedpertreated acre. Thatis, the average application rate of0.6 lb. a.i. per acre is equivalentto 600 lbs. a.i. per 1,000 acres. The highestrange for use intensity is between4 and 11lbs. a.i. per 1,000 acres. Figure 3 spatially represents fenhexamid's relative intense use in the US. for strawberries in Southern and Coastal California. The relatively moderate use intensity in Central Florida is also likely driven by use on strawberry, while those areas in California and Washington may be use on grapes. The relatively highuse intensity in Long Island andNew York is likely a function ofvery limited farm land.

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### Figure 3. Fenhexamid Usage by 

### Crop Reporting District (2006- 2010)

Average Pounds Per 1,000 Acres of Farmland

- <0.3 0.3-0.7 

## D o.a-2
.1 2.2-4.1 4.2- 11.1 Sources: Proprietary Data. 2006-20I0 USDA, 2006-20IO. NASS Crop Reporting Districts. http://www.ers.usda.gov/briefmg/arms/resourceregions/ resourceregions.htm#nass
. USDA, 2007. Census ofAgriculture. http://www.agcensus.usda.gov/Publications/2007/index.asp
. This is a map ofagricultural pesticide usage at the Crop Reporting District (CRD) level prepared by BEAD for use in the Environmental Fate and Effects Division documents. These maps are used to help visualize where the pesticide being considered is most likely to be used and can be helpful in scenario selection and placing the exposure assessment in context. CRDs are boundaries created by USDA NASS which are aggregates ofcounties (USDA, 20IO). Pesticide usage is displayed as average pounds (for the years 2006- 20I0) per I,000 acres of farmland in a CRD to normalize for the variation in farmland between CRDs. Farmland acreage was obtained from USDA (2007). Farmland or "land in farms" is defined as follows: The acreage designated as "land in farms" consists primarily ofagricultural land used for crops, pasture, or grazing. It also includes woodland and wasteland not actually under cultivation or used for pasture or grazing, provided it was part of the farm operator's total operation. Large acreages of woodland or wasteland held for nonagricultural purposes were deleted from individual reports during 5the edit process. Land in farms includes CRP, WRP, FWP, and CREP acres. Land in farms is an operating unit concept and includes land owned and operated as well as land rented from others. Land used rent free was reported as land rented from others. All grazing land, except land used under government permits on a per-head basis, was included as "land in farms" provided it was part ofa farm or ranch. Land under the exclusive use ofa grazing association was reported by the grazing association and included as land in farms. All land in American Indian reservations used for growing crops, grazing livestock, or the potential of grazing livestock was included as land in farms. Land in reservations not reported by reservation, individual American Indians or nonNative Americans was reported in the name ofthe cooperative group that used the land. In many instances, an entire American Indian reservation was reported as one farm (2007 Census ofAgriculture, USDA). Usage is based on private market surveys ofpesticide use in agriculture (Proprietary Data, 2006-2010). The survey data are limited to the states that represent the top 80-90% of acreage for the individual crops; therefore, use may be occurring in regions outside the scope of the survey. CRDs showing no usage of pesticides may be due to either the lack ofpesticide use in the region or non-participation in the agricultural surveys. In addition, across the years, there may be variations in the specific crops included in the CRD survey. This may result in a lower annual average for the CRD. This map displays ratio data (i.e., average pounds per 1,000 acres offarmland) summarized at a very highlevel. Readers are strongly cautioned against trying to over interpret the map without examination ofthe underlying data. The underlying data may explain some ofthe many reasons that a Crop Reporting District may have a high value for a particular active ingredient such as significant acreage (compared with the CRD as a whole) ofa crop or crops with a high applicationrate and frequency ofapplication. The reader should pay particular attention to the figure legends and realize that a map prepared for a particular chemical is not directly comparable to a map prepared for a different chemical. Scale and units of measurement do matter and may be different between maps. 

### Non-AgriculturalUsage The available data showuse offenhexamid on nursery and floriculture to be 2,000 lbs. a.i. in 2002 and 2004, 5,000 lbs. a.i. in 2006, and rising to 6,000 lbs. a.i. in 2009. 

### Source: Kline and Company, Inc., 2002,2004,2006, and 2009. USDA NASS, Agricultural Chemical Usage Report, 2009 

### BIOLOGICAL ASPECTS RELEVANT TO FENHEXAMID Botrytis cinerea, one ofthe maintargets offenhexamid use, is among the top tenplant pathogens that have a highrisk ofdevelopment ofresistance to fungicides (FRAC, 2012). The disease control and resistance managementprogram involves fungicides with different modes ofaction, and fenhexamid is one ofthe mostrecent botryticides (Debieu et al. 2001; Fillinger et al. 2008). Fenhexamid is a Group 17 fungicide. In general, this group offungicides has a lowto medium intrinsic risk in resistance development, and resistance management is required (FRAC, 2013). In addition, combinedresistance risk inthis case could increase to as high as 6 in a scale of 1 - 9 (FRAC, 2013) whenthe pathogen risk is considered. Resistance management practices described onthe label include no more thantwo consecutive applications with a fenhexamid product may be made, and alternation or tank 

### mixture with other fungicides is recommended.
6HISTORY OF BEAD ASSESSMENTS FORFENHEXAMID 

### Two section 18 requests for fenhexamid were reviewed by BEAD as below. In 2001, California's request for section 18 use offenhexamid (Elevate) as a postharvestpear treatmentto control gray mold disease caused byBotrytis cinerea was not supported by BEAD as the submitted data were not adequate enoughto supportthe case (Chand-Goyal, 2001). In 2003, Texas requested a section 18 use offenhexamid (Decree® 50 WDG) to control Botrytis on greenhouse tomatoes. BEAD found that the data submitted did not indicate that growers would incur significant economic losses due to an outbreak ofBotrytis for the 2003 season. DATANEEDS RELEVANT TO BEAD'S FUTURE WORK ON FENHEXAMID 

### Additional information, interms ofaverage andmaximum percent crop treated, pounds a.i. applied, average applicationrate, regional application, time ofapplication, number ofapplication peryear and/or per season, and any other available data on both agricultural and non-agricultural sites (nurseries and greenhouses) from the registrant would improve future BEAD assessments of the importance offenhexamidand may be required as part oftheregistrationreview ofthis pesticide. REFERENCES http://www.docstoc.com/docs/7832216/Fenhexamid 

### Chand-Goyal, Tara. 2001. California'srequest for section 18 use offenhexamid (Elevate) as a postharvestpeartreatmentto control gray mold disease caused by Botrytis cinerea. EPA/OPP. Debieu D, Bach

### J, Hugon M, Malosse C, Leroux P. 2001. The hydroxyanilide fenhexamid, a new sterol biosynthesis inhibitor fungicide efficient against the plantpathogenic fungus Botryotinia fuckeliana (Botrytis cinerea). Pest Manag Sci. (11): 1060-7. http://www.ncbi.nlm.nih.gov/pubmed/11721524
. Fillinger S, Leroux P, Auclair C, Barreau C, AI Hajj C, Daniele D. 2008. Genetic analysis of fenhexamid-resistant field isolates ofthe phytopathogenic fungus Botrytis cinerea. Antimicrob. Agents Chemother. 52:3933-3940. http://aac.asm.org/content/52/11/3933.full. FRAC. 2012. Fungicide Resistance Action Committee. http://www.frac.info/frac/index.htm Accessed October 2012. Proprietary Data, 1999-2011



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### USDA, 2006-2010. NASS Crop Reporting Districts. Online: http://www.ers.usda.gov/briefing/arms/resourceregions/resourceregions.htm#nass
. USDA, 2007. Census ofAgriculture. Online: http:/ /www.agcensus.usda.gov /Publications/2007 /index.asp. http://www.extension.org/pages/29324/fenhexamid http:/ /iaspub.epa.gov/apex/pesticides/f?p=CHEMICALSEARCH:3:0::NO: 1,3,31,7,12,25:P3 XC HEMICALID:2353http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&rgn=div8&view=text&node=40:25.0.1.1.28.3.19.285&idno=40 http://guickstats.nass.usda.gov/results/96FOIA45-2464-34D5-A034- D41C48C57824#42B2940A-16El-3C8C-B440-FC054B9C8630 Kline and Company, Inc., 2002, 2004, 2006, and 2009 Wyatt, T.J. and Richard Michell. Texas request ofsection 18 use offenhexamid (Decree® 50 WDG) to control Botrytis on greenhouse tomatoes. EPA/OPP. May 14,2003.



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