### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460 

### MAY 23 

### lOll

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM SUBJECT:

FROM: Percent Crop Treated for New Uses ofFluopyram on Cantaloupe, Cucumber, Dry Beans, Peanuts, Potatoes, Pumpkin, Squash, Sugar Beet, and Watermelon. Analysis ofthe Bayer Crop Science PercentCrop Treated Estimates for Rotated Crops (Wheat, Corn, Sorghum, Barley, Oats, Rye, Millet, Soybeans, Canola, Cotton, and Alfalfa) from the Combined Acreage ofDry Beans and Potatoes PC#080302, DP# 387227 Jihad Alsadek, Ph.D., Economist

# T~ tb

# /)~ 

# 4 Science Information and Analysis Branch



### THRU: Carl Chen, Ph.D., PlantPathologist Biological Analysis Branch Biological and Economic Analysi

ArnetJones, Chief

. Biological Analysis Branch

' Biological and Economic Analysis Divi 0 

### TO: LisaJones, Senior Reviewer Fungicide Branch Registration Division (7505P) 

### ProductReview Panel: May 4, 2011 I. SUMMARY In this memo BEAD is providing percent crop treated for new use (pCTn) estimates of the fungicide fluopyram for cantaloupe, cucumber, dry beans, peanuts, potatoes, pumpkin, squash, sugarbeets, and watermelon, To calculate these PCTn values, BEAD used recent data from the National Agricultural Statistics Service (NASS) 2002-2006, and recentproprietary data (2006-2010).BEAD recommends that the average PCTn values in Table 1 be used for chronic risk assessment, and the maximum PCTn values be used for acute risk assessment. For the rotational crops, BEAD recommends using the PCTn values for the rotational crops in Table 4 for chronic assessment offluopyram for plant back after dry beans and potatoes. At HED's request, BEAD also reviewed PPCT estimates submitted by Bayer Crop Sciences (BCS). The term PPCT used by BCS is the equivalent ofthe EPA's PCTn (Bayer, 2011). BEAD PCTn values were compared with those submitted by the registrant as shown in Table 2

. Additionally, HED requested that BEAD analyze the approach BCS used to estimate PCT for rotated crops (wheat, com, sorghum, barley, oats, rye, millet, soybeans, canola, cotton, and alfalfa) from the combined acreage ofdry beans and potatoes. The results are shown 

### in Table 4. 

### II. FEDERAL REGISTER LANGUAGE
EPA's estimate ofthe percent crop treated for the new uses (PCTn) offluopyram represent the upperbound ofuse expected during the pesticide's initial five years ofregistration; that is, the PCTn for fluopyram is a threshold ofuse that EPA is reasonably certain will not be exceeded for this registered use site. The PCTnrecommended for use in the chronic dietary assessment is calculated as the average percent crop treated (PCT) ofthe market leaderor leaders (i.e., the one(s) with the greatestPCT) on that crop overthe three most recent years ofavailable data. The PCTn recommended for use in the acute dietary assessment is the maximum observed PCT overthe same period. Comparisons are only made among pesticides ofthe same pesticide types (e.g., the market leader for fungicides on the use crop is selected for comparison with a new fungicide). The market leader included in the estimation may not be the same for each year since different pesticides may dominate at differenttimes. Typically, EPA uses USDA/National Agricultural Statistics Service (NASS) surveys as the source databecause they are publicly available and directly report values for PCT. When a specific use crop is not reported by USDAINASS or the NASS data are very dated, EPA uses proprietary data and calculates the PCT based on reported data on acres treated and acres grown. Ifno proprietary data are available, EPA may extrapolate PCTn from other crops ifthe production area and pest spectrum are substantially similar

. A retrospective analysis to validate this approach shows few cases where the PCT for the market leaders were exceeded, (EPA, 2006)

. Furtherreview ofthese cases identified factors contributing to the exceptionally high use ofa new pesticide. To evaluate whetherthe PCTn for fluopyram could be exceeded, EPA considered whether or not there may be unusually high pest pressure, as indicated in emergency exemptionrequests for fluopyram, the pest spectrum ofthe new pesticide in comparison with the market leaders, whether or not the market leaders are wellestablished for that use and whether or not pestresistance issues with pastmarket leaders provide fluopyram with significantmarket potential. Given currently available information, BEAD concludes that it is unlikely that actual PCT for fluopyram will exceedthe estimated PCT for new uses during the next five years.
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### III. PROJECTIONS BASED ON MARKET LEADERAPPROACH
BEAD used the market leader approach to derive the PCTn values presented in Table 1. The market leader approach utilizes PCT datafor the chemicals that dominate the marketto assign a conservative upper bound PCT value for the new use. The market leader approach is backed by an analysis ofthe comparison ofthe PCT with new uses (from tolerances established over a 10 year period) to the PCT with market leaders overthat same period. BEAD found that over 95% ofthe time, the new pesticide or new use ofa registered pesticide is not likely to overtake the market leaderfor the pesticide type (i.e. fungicide in this case) and crop within the first five years following registration, (EPA, 2006).
The PCT value is taken directly from NASS data, or ifproprietary data are used, BEAD calculates the PCT value by dividing the base area treated (the area treated at least one time by a given pesticide) by the crop acres grown and multiplying the value by 100. The fungicide with the highest PCT for each data year was designated as the market leader and the PCT values associated with the market leader(s) were used to derive the PCTn values for the new crop. The PCTn values to be used in chronic risk assessments for new uses are derived by taking the average ofthe market leaderPCT values. The PCTn value to be used in acute risk assessments is the highest value among the available years ofPCT data

. BEAD previously provided datafor almonds, apples, peaches, wine grapes, oranges, pears, strawberries, and fresh tomatoes (AIsadek

### J. and Chen C., February 23, 2011)

. For this request, BEAD reviewed USDA! NASS pesticide use surveys for fungicide usage data on cantaloupe, cucumber, peanuts, potatoes, pumpkin, squash, and watermelon. BEAD used proprietary data for dry beans and sugarbeets since NASS data are either dated or not available for these crops.
Table 1. Fluopyram PCTn for Cantaloupe, Cucumber, Dry Beans, Peanuts, Potatoes, Pumpkin, Squash, Sugar Beet, and Watermelon.

Cron Market Leader (MU Chemical AVl!MLPCTn Max ML PCTn Cantaloupe" Sulfur 

### 22 31 Triflumizole Cucumber" Chlorothalonil 

### 41 52 Dry Beans" Thiophanate-Methyl 

### 7 14 Pvraclostrobin Peanuts" Chlorothalonil 

### 67 70 Mancozeb Potatoes" Mancozeb 

### 64 64 Chlorothalonil Pumpkin" Chlorothalonil 

### 45 57 Squash" Chlorothalonil 

### 47 54 Sugar Beetsa Tetraconazole 

### 48 53 Pvraclostrobin Watermelon" Chlorothalonil 

### 54 58
• a Proprietary data (2006-.2010) • b NASS data (2002-2006)

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### IV. Evaluation ofDCS PPCT Estimates and Analysis ofRotational Crop PCT Methodology Submitted by DeS
To evaluate the BCS PPCT estimates BEAD reviewed the most recentNASS datawhere available for all crops. When NASS data were unavailable, the most recentproprietary data were used. The methods differ in terms ofdata sources and years ofusage data. BCS used the average ofthe highest competitor values from the last five years (2005':'2009) ofproprietary data for all the nine crops as shown in Table 2 (Bayer, 2011). BEAD's method used the most recent NASS data (2002-2006) for all the crops in Table 2, except for dry beans and sugarbeets, where BEAD used the most recent proprietary datadue to the unavailability ofNASS data for these two crops.
Table 2. BEAD Average ML PCTns Compared to BCS PPCTs for Cantaloupe, Cucumber, Dry Beans, Peanuts, Potatoes, Pumpkin, Squash, Sugar Beets, and Watermelon Crop Market Leader (ML) Chemical BEAD Avg ML 

### BCS Difference PCTn 

### PPCTs 

### (%) Cantaloupe" Sulfur/Triflumizole 

### 22 34 55 Cucumber" Chlorothalonil 

### 41 47 15 Dry Beans" Thiophanate-Methyl/ 

### 7 10 43 Pyraclostrobin Peanuts" Chlorothalonil/Mancozeb 

### 67 67 0 Potatoes" Mancozeb/ Chlorothalonil 

### 64 60 -6 Pumpkin" Chlorothalonil 

### 45 50 11 Squash" Chlorothalonil 

### 47 54 15 Sugarbeets" TetraconazolelPyraclostrobin 

### 48 46 -4 Watermelon" Chlorothalonil 

### 54 59 9
• a Propnetary data (2006-2010) • b NASS data (2002-2006)
In orderto evaluate the methodology BCS used to determine PPCTs for rotated crops (wheat, com, sorghum, barley, oats, rye, millet, soybeans, canola, cotton, and alfalfa) from the combined acreage ofdry beans and potatoes, BEAD reviewed the NASS data used by BCS as shown in Table 3

. The NASS data used by BCS for determining the PPCTs for their rotational crops analysis are publicly available. In orderto calculate the dry bean and potato treated acreage, BEAD used NASS data (2003) for potatoes (64%) and proprietary data (2006-2010) for dry beans (7%) because NASS data were not available (Table 3).
The BCS methodology assumed that each rotational crop is planted back onboth acreage ofdry beans and potatoes (808,000 acres). It was assumed that 100 percent ofthe maximum available acreage (808,000 acres) could be planted back with each ofthe possible rotational crops, where plant back statements on the product labels reflect the ability to rotate to cereals, com, and soybeans, only after dry beans and potatoes (Bayer, 2011). The treated acreage is derived by multiplying the five-year average for the combined planted acres ofdry beans and potatoes by the percent ofacreage treated for each ofthese two crops. The PCTn for these rotational crops that follows the treated acreage ofdry beans and potatoes, as shown in Table 4, is derived by 4

### dividing this fixed value (808,000 planted acres from dry beans and potatoes) by the five-year average ofeach individual rotational crop's planted acreage as shown in Table 3.
As BCS explains 

### in theirRevised Portfolio submission (Bayer, 2011) "formostcrops permitted rotation have been limited to primary crops for which rotational crop data are available (cotton and alfalfa). Dry beans and potatoes require additional plantback options to canola, com, cereals, and soybeans. The plantback statements on the product labels have been modified to reflectthese limitations on crop rotations."
In the absence ofsufficientrotational crop data, BCS defaulted to the highly conservative target crop residue data for use 

### in the dietary risk assessment and for setting rotational crop tolerances. The potential treated acres for each ofthe primary crops (dry beans and potatoes) which could be rotated to other crops were determined and added together

. BCS assumed that 100percent ofthat maximum available acreage (808,000 acres) could be planted back with each ofthe possible rotational crops as shown in Table 4 (Bayer, 2011).

Table 3. Fluopyram Treated Acres ofPlanted Dry Beans and Potatoes and Ready for Plant Back by Rotational Crops
Data 5 Year BEAD Treated. Items 2010 2009 2008 2007 2006 Av£!. PCTn Acres Dry Beans 1,911,400 1,540,000 1,495,000 1,527,400 1,622,800 1,619,320 7* 113,352.40
Potatoes 1,020,600 1,068,100 1,059,600 1,141,900 1,139,400 1,085,920 64** 694,988.80
Maximum acreage available for plant back/rotation 808,341.20 Source: http://www.nass.usda.gov/Statistics by Subject/index.php?sector=CROPS *Proprietary Data (2004-2008) **NASS (2003)

5Table 4. PCTn for Rotated Crops Dry Beans and Potatoes Data Items Acres Treated 5 Year Ave;

. PCTn Rotated Crops Wheat 808,000 59,000,000 1 Com 808,000 86,000,000 1 Sorghum 808,000 7,000,000 12 Barley**80~ ,000**  4,000,000 22 Oats 808,000 4,000,000 23 Rye 808,000 1,000,000 63 Millet 808,000 482,000 100 Soybeans 808,000 74,000,000 1 Canola 808,000 1,000,000 73 Cotton 808,000 11,000,000 7 Alfalfa 808,000 20,000,000 4 Source: http://www.nass.usda.gov/Statistics by Subject/index.php?sector=CROPS



# v. ADDITIONAL FACTORS 

### There are three main factors BEAD considers in evaluating the likelihood that use ofa newly registered chemical or a new use will exceed the PCT for new uses: (l) 

### the extent ofpest pressure on the crops in question; (2) the pest spectrum ofthe new pesticide in comparison with the market leaders as well as whetherthe market leaders are well-established for this use; and (3) resistance concerns with the new pesticide and the market leaders. High pest pressure with the lack ofregistered controls could indicate significant demand for a new chemical. Emergency exemptions under section 18 ofFIFRA are a good indicatorin regard to these situations. On the other hand, it would be relatively difficult for a new active ingredientto gain a large portion of the market ifa) it competes with the market leader(s) or others that have been extensively used for pest control including the same targetpest(s), b) its new use is limited, for example, registered only for a single pest, and/or c) it is labeled for pest(s) ofminor economic concern. Finally, ifthe target pests are developing resistance to the market leader(s), it could indicate an advantage for the new active ingredient in the market. Fluopyrambelongs to achemical group functioning as a succinate dehydrogenase inhibitor (SDHI) and is labeled for use on a variety ofcrops. HED requested fluopyram PCTn for 10 crops at this time: almonds, dry 

### beans, peanuts, potatoes, sugar beets, and five cucurbits

. A biological analysis ofadditional factors for the use offluopyram on almonds has been provided in Alsadek and Chen (2011), which concludes that 

### it is unlikely that the use of fluopyram will exceed the market leader levels on almonds. For the remaining nine crops, the analysis ofthe three main factors follows (Table 5).

6Table 5: A List of the Registered Disease Control/Suppression on Dry Beans, Peanuts, Potatoes, Sugar Beets, and Five Cucurbits by Fluopyram 500 SC Fungicide. Commodity Diseases Labeled for Fluopyram CUCURBIT VEGETABLES Alternaria leafspot (Alternaria spp.); Gray mold (Botrytis (CANTALOUPE, CUCUMBER, cinerea); Gummy stem blight (Didymella bryoniae); Powdery PUMPKIN, SQUASH, mildew (Sphaeothecafuliginea, Podosphaeraxanthii, Erysiphe WATERMELON) cichoracearum) Alternariablight (Alternaria spp.); Alternarialeafspot DRIED BEANS (Alternaria alternate); Gray mold (Botrytis cinerea); Powdery mildew (Erysiphe pisiy; White mold (Sclerotinia sclerotiorum) PEANUT Early leafspot (Cercospora arachidicolay ;Late leaf spot (Cercosporidium personatumt Botrytis leafspot (Botrytis cinerea); Early blight (Alternaria POTATO solaniy; White mold (Sclerotinia sclerotiorum); Silver scurf (Helminthosporium solanii SUGAR BEET Cercospora leafspot (Cereospora beticolay; Powdery mildew (Erysiphe polygoniy


### In addition, HED requested fluopyram PCTn for rotational crops that are alfalfa, canola, cotton, soybean, and cereal grains except rice. After the harvest ofdry 

### beans and potatoes, 100% ofthe acreage treated with fluopyram is assumed to growthese rotational crops. Thus, it is a conservative estimate and no analysis on additional factors is needed.
CUCURBITS - The market leaders are sulfur and triflumizole for cantaloupe, and chlorothalonil for cucumber, pumpkin, squash, and watermelon. • Pest pressure: No FIFRA Section 18 Emergency Exemptionhas been currently issued for the use ofany fungicides to control the labeled diseases on cantaloupe, cucumber, pumpkin, squash, and watermelon. • Pest spectrum: The market leader fungicide, chlorothalonil, has been registered to control the same target diseases as fluopyram on cucumber, pumpkin, squash, and watermelon. The market leader fungicides, sulfur and/or triflumizole, have been registered to control the same target diseases as fluopyram on cantaloupe. Two ofthem, chlorothalonil and sulfur, are broad-spectrum fungicides with a multi-site mode ofaction, where fluopyram has a single-site mode ofaction.

• Resistance: The Fungicide Resistance Action Committee (FRAC) indicates that chlorothalonil and sulfur, the market leaders on cantaloupe, cucumber, pumpkin, squash, and watermelon are generally consideredto be at low risk for resistance development. Triflumizole, one oftwo market leaders on cantaloupe, is ahigh-risk-for-resistancedevelopment fungicide. FRAC ranks fluopyram as medium to high risk for resistance development and indicates that resistance management is required (FRAC, 2011). Conclusion: Consideration ofthese factors indicates that it is unlikely that the use of fluopyram will exceed the market leader levels on cucurbits identified. In particular, fluopyram will unlikely gain a large portion ofthe market when it competes with the market leaders that have been extensively used to control the same diseases. It 

### is also because fluopyram competes with other fungicide alternatives currently available on cucurbits, which would reduce its use and usage. As a medium to high risk fungicide for resistance
7development, fluopyram also does not have a clearmarket advantage in resistance management because 

### it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode ofaction, which would limit its use and usage. 

### DRY BEANS

- The market leaders are thiophanate-methyl and pyraclostrobin

. • Pest pressure: No FIFRA Section 18 Emergency Exemption has been currently issued for the use ofany fungicides to control the labeled diseases on dry beans

. • Pest spectrum: The market leader fungicides, thiophanate-methyl and/orpyraclostrobin, have been registered to control the same target diseases as fluopyram on dry beans.

• Resistance: FRAC indicates thatpyraclostrobin and thiophanate-methyl are high-riskfor-resistance-development fungicides. With different chemistries, both can be rotated or tank-mixed to reduce the risk ofresistance development. It is also found that EPA Proprietary Data indicate that both were actually used to control all the main diseases labeled for fluopyram, and the fact that both were still market leaders suggests that in this particular case resistance might not be a dominating factor compared to fluopyram. FRAC ranks fluopyram as medium to high risk for resistance development and indicates thatresistance management is required (FRAC, 2011). Conclusion: Consideration ofthese factors indicates that it is unlikely that the use of fluopyram will exceed the market leader levels on dry beans. In particular, fluopyram will unlikely gain a large portion ofthe market when it competes with the market leader fungicides that have been applied to control the same diseases. It is also because fluopyram competes with other fungicide alternatives currently available on dry beans, which would reduce its use and usage. In addition, as a medium to high risk fungicide for resistance development, fluopyram does not have a clearmarket advantage in resistance management because it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode ofaction, which would limit its use and usage. 

### PEANUT

- The market leaders are chlorothalonil and mancozeb.

• Pestpressure: No FIFRA Section 18 Emergency Exemption has been currently issued for the use ofany fungicides to control the labeled diseases on peanuts.

• Pest spectrum: The market leader fungicides, chlorothalonil and/or mancozeb, are broadspectrum fungicides with a multi-site mode ofaction that have beenregistered to control the same target diseases as fluopyram on peanuts.

• Resistance: FRAC indicates that the market leader fungicides, chlorothalonil and mancozeb, are generally considered to be at low risk for resistance development. FRAC ranks fluopyram as medium to high risk for resistance development and indicates that resistance management is required (FRAC, 2011)

. Conclusion: Consideration ofthese factors indicates that it is unlikely that the use of fluopyram will exceed the market leader levels on peanuts

. In particular, fluopyram will unlikely gain a large portion ofthe market when it competes with the market leaders that have been extensively used to control the same diseases. It is also because fluopyram competes with other fungicide alternatives currently available on peanuts, which would reduce its use and usage. As a medium to high risk fungicide for resistance development, fluopyram also does not have a clear market advantage in resistance management because it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode ofaction, which would limit its use and usage. S

### POTATO - The market leaders are chlorothalonil and mancozeb. • Pest pressure: No FIFRA Section 18 Emergency Exemption has been currently issued for the use ofany fungicides to control the labeled diseases on potatoes. • Pest spectrum: The market leader fungicides, chlorothalonil and/or mancozeb, have been registeredto control the same target diseases as fluopyram on potatoes. Both ofthem are broad-spectrum fungicides with a multi-site mode ofaction.

• Resistance: FRAC indicates that the market leader fungicides, chlorothalonil and mancozeb, are generally considered to be at low risk for resistance. FRAC ranks fluopyram as medium to high risk for resistance development and indicates that resistance management is required (FRAC, 2011)

. Conclusion: Consideration ofthese factors indicates that it is unlikelythat the use of fluopyram will exceed the market leader levels on potatoes. In particular, fluopyram will unlikely gain a large portion ofthe market when it competes with the market leaders that have been extensively used to control the same diseases. It is also because fluopyram competes with other fungicide alternatives currently available on potatoes, which would reduce its use and usage. As a medium to high risk fungicide for resistance development, fluopyram also does not have a clear market advantage in resistance management because it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode ofaction, which would limit its use and usage.
SUGAR BEETS - The market leaders are pyraclostrobin and tetraconazole.

• Pestpressure: No FIFRA Section 18 Emergency Exemptionhas been currently issued for the use ofany fungicides to control the labeled diseases on sugar beets. • Pest spectrum: The market leader fungicides, pyraclostrobin and/or tetraconazole, have beenregistered to control the same target diseases as fluopyram on sugarbeets.

• Resistance: FRAC indicates that pyraclostrobin and tetraconazole are high-risk-forresistance-development fungicides. With different chemistries, both can be rotated or tank-mixed to reduce the risk ofresistance development. It is also found thatEPA Proprietary Data indicate that both were actually used to control all the main diseases labeled for fluopyram, and the fact that both were still market leaders suggests that in this particular case resistance might not be a dominating factor compared to fluopyram

. FRAC ranks fluopyram as mediumto highrisk for resistance development and indicates that resistance management is required (FRAC, 2011). Conclusion: Consideration ofthese factors indicates that it is unlikely that the use of fluopyram will exceed the market leader levels on sugar beets. In particular, fluopyram will unlikely gain a large portion ofthe market when it competes with the market leader fungicide that has been extensively used to control the same diseases. It is also because fluopyram competes with other fungicide alternatives currently available on sugar beets, which would reduce its use and usage. In addition, as a medium to highrisk fungicide for resistance development, fluopyram does not have a clear market advantage in resistance management because it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode ofaction, which would limit its use and usage

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### VI. CONCLUSIONS/RECOMMENDATIONS
BEAD recommends that the average PCTn values for almond, cantaloupe, cucumber, dry beans, peanut, potatoes, pumpkin, squash, sugar beet, and watermelon, provided in Table 1 be used in the chronic dietary risk assessment for fluopyram and the maximum PCTn values be used for acute risk assessment. BEAD also recommends the PCTn values for the rotational crops, in Table 4, be used for chronic assessment for fluopyram forplant back after dry beans and potatoes. BEAD has considered all available relevant information and believes it is unlikely that the PCTn values provided in Table 1 and Table 4 will be exceeded during the next five years.



### VII. REFERENCES Agricultural Chemical Usage 2002 Vegetables Summary Agricultural Chemical Usage 2004 Vegetables Summary Agricultural Chemical Usage 2006 Vegetables Summary AlsadekJ., Chen C. 2011. Refined Percent Crop Treated for New Uses ofFluopyram on Almonds, Apples, Wine Grapes, Oranges, Peaches, Pears, Strawberries, and Tomatoes PC #080302, DP # 381225, DP # 378732. February 23,2011. Bayer, 2011. Revised portfolio for fluopyram use: January 19, 2011.
EPA, 2006

. Memorandum: "BEAD Approach to Providing Projected Percent Crop Treated Estimates for Use in Dietary Risk Assessment in OPP", December 14,2006. Unpublished.
EPA Proprietary Data, 2006-2010.
FRAC, 2011. Fungicide Resistance Action Committee. http://www.frac.info/frac/index.htm

cc: Cynthia Giles-Parker; BarbaraMadden; Paula Deschamp

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