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: 

THRU: 

TO: 

Carl Chen, Plant Pathologist 

Biological Analysis Branch 

Jihad Alsadek, Economist J v4-/ A-~ -14~ Science Information and Analysis Branch 

Andrew Lee, Economist ak C- ~ Economic Analysis Branch / r. 

Biological and Economic Analysts Division (7503P) 

Arnet Jones, Chief ~ 

Biological Analysis Branch 

Diann 

Science 

Sims, 

Informatio Chief rfati /~~ Analysis Branch 

Timothy 

Economic Kiely, Analysis 

Chief 

Branch ~ L. vv 

" \. t I~ 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 of this document is to convey usage information and a broad overview of the pest 

management roles of pesticides that are beginning to undergo registration review. The 

anticipated audience consists of the team of EPA staff currently evaluating the registration status 

of fenhexamid and eventually the general public. This document builds upon the data already 

1 
provided in the "Usage and Label Use Data Packages" that are also provided to Registration 

Review teams by BEAD. The document is based on information and data available to BEAD as 

of October 2012. 

Fenhexamid belongs 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 used to control some important plant diseases including Botrytis cinerea on blueberries, 

caneberries, cherries, grapes, peaches, pistachios, and strawberries. Fenhexamid is also 

registered for use on greenhouse and nursery-grown ornamentals to control Botrytis and powdery 

mildew diseases. 

COMMON FORMULATIONS AND APPLICATION METHODS 

Fenhexamid is formulated as water dispersible granules. The product is 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 on ornamental 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 of fenhexamid in terms of total pounds a.i. used during the period 1999-

20 11. The initial registration for this chemical was in 1999. The use of fenhexamid in terms of 

lbs. a.i. applied increases throughout the whole period (1999-2011). The increase seems to be 

steady with the exception of some down years in 2007 and 2009. 

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Figure 1. Agricultural Usage Data for 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 with the most usage, strawberries, wine and table 

grapes from 2007-2011. The use of fenhexamid on strawberries fluctuated between 2007 and 

2011. The use on wine and table grapes, and on other crops was rising during the same time 

period, 2007-2011. 

Fi 

70,000 

Strawberries 

---Grapes, Wine 

-A-Grapes, Table 

Other 

0 

Years 

3 
Other crops include caneberries (6%), raisin grapes (4%), and the rest of the 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 170,000 treated acres with an overall application rate of 0.6 lbs. a.i. per 

acre. 

Table 1, for the same time frame (2007-2011), shows the crops with the most use in terms of 

total pounds of active ingredient applied and total acres treated (TAT) in acres. 

Table 1. Fenhexamid's Percent of Top Crops in Terms ofLbs. Applied & TAT in Acres 

(2007-2011) 

Crops - -- - - -, % Pounds A lied % Total Area Treated 

Strawberries 41 34 

33 37 

16 17 

Source: 

Proprietary Data, 2007-2011 

On average, the states with the most agricultural usage in terms of pounds 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 of usage is the use intensity. In this analysis, the use intensity is expressed as 

the pounds a.i. applied per 1,000 acres ofland in farms. This differs from the application rate, 

which is expressed as the pounds a.i. applied per treated acre. That is, the average application 

rate of 0.6 lb. a.i. per acre is equivalent to 600 lbs. a.i. per 1 ,000 acres. The highest range for use 

intensity is between 4 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 high use intensity in 

Long Island and New York is likely a function of very 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. 2006-20 I 0 

USDA, 2006-20IO. NASS Crop Reporting Districts. 

http://www.ers.usda.gov/briefmg/arms/resourceregions/resourceregions.htm#nass. 

USDA, 2007. Census of Agriculture. http://www.agcensus.usda.gov/Publications/2007/index.asp. 

This is a map of agricultural 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 of counties (USDA, 20IO). Pesticide usage is displayed as average pounds (for the years 2006-

20 I 0) 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 of agricultural 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 

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the 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 of a farm or ranch. Land under the exclusive use of a 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 of the cooperative group that used 

the land. In many instances, an entire American Indian reservation was reported 

as one farm (2007 Census of Agriculture, USDA). 

Usage is based on private market surveys of pesticide 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 of pesticide 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 of farmland) summarized at a very highlevel. Readers are strongly cautioned against trying to over interpret the map without examination of the 

underlying data. The underlying data may explain some of the 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) of a crop or crops with a high application rate and frequency of application. 

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-Agricultural Usage 

The available data show use of fenhexamid 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 of the main targets of fenhexamid use, is among the top ten plant pathogens 

that have a high risk of development of resistance to fungicides (FRAC, 20 12). The disease 

control and resistance management program involves fungicides with different modes of action, 

and fenhexamid is one of the most recent botryticides (Debieu et al. 2001; Fillinger et al. 2008). 

Fenhexamid is a Group 17 fungicide. In general, this group of fungicides has a low to medium 

intrinsic risk in resistance development, and resistance management is required (FRAC, 2013). 

In addition, combined resistance risk in this case could increase to as high as 6 in a scale of 1 - 9 

(FRAC, 2013) when the pathogen risk is considered. Resistance management practices 

described on the label include no more than two consecutive applications with a fenhexamid 

product may be made, and alternation or tank mixture with other fungicides is recommended. 

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HISTORY OF BEAD ASSESSMENTS FOR FENHEXAMID 

Two section 18 requests for fenhexamid were reviewed by BEAD as below. 

In 2001, California's request for section 18 use of fenhexamid (Elevate) as a postharvest pear 

treatment to control gray mold disease caused by Botrytis cinerea was not supported by BEAD 

as the submitted data were not adequate enough to support the 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 of Botrytis for the 2003 season. 

DATA NEEDS RELEVANT TO BEAD'S FUTURE WORK ON FENHEXAMID 

Additional information, in terms of average and maximum percent crop treated, pounds a.i. 

applied, average application rate, regional application, time of application, number of application 

per year 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 offenhexamid and may be required as part ofthe registration review of this 

pesticide. 

REFERENCES 

http://www.docstoc.com/docs/7832216/Fenhexamid 

Chand-Goyal, Tara. 2001. California's request for section 18 use offenhexamid (Elevate) as a 

postharvest pear treatment to 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 plant pathogenic 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 of the 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 of Agriculture. 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:2353 

http://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 of section 18 use offenhexamid (Decree® 50 

WDG) to control Botrytis on greenhouse tomatoes. EPA/OPP. May 14,2003. 

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