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 of Fluopyram on Cantaloupe, Cucumber, Dry

Beans, Peanuts, Potatoes, Pumpkin, Squash, Sugar Beet, and Watermelon.

Analysis ofthe Bayer Crop Science Percent Crop 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., Plant Pathologist

Biological Analysis Branch

Biological and Economic Analysi

Arnet Jones, Chief .

Biological Analysis Branch

'Biological and Economic Analysis Divi 0

TO: Lisa Jones, Senior Reviewer

Fungicide Branch

Registration Division (7505P)

Product Review 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, sugar beets, and watermelon, To calculate these PCTn values, BEAD used recent data

from the National Agricultural Statistics Service (NASS) 2002-2006, and recent proprietary 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 of dry 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 upper bound of use expected during the pesticide's initial five years ofregistration;

that is, the PCTn for fluopyram is a threshold of use that EPA is reasonably certain will not be

exceeded for this registered use site. The PCTn recommended for use in the chronic dietary

assessment is calculated as the average percent crop treated (PCT) ofthe market leader or leaders

(i.e., the one(s) with the greatest PCT) on that crop over the three most recent years of available

data. The PCTn recommended for use in the acute dietary assessment is the maximum observed

PCT over the 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 different times.

Typically, EPA uses USDA/National Agricultural Statistics Service (NASS) surveys as

the source data because 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.

If no 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). Further review ofthese cases identified factors

contributing to the exceptionally high use of a new pesticide. To evaluate whether the PCTn for

fluopyram could be exceeded, EPA considered whether or not there may be unusually high pest

pressure, as indicated in emergency exemption requests 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 pest resistance issues with past market leaders provide

fluopyram with significant market potential. Given currently available information, BEAD

concludes that it is unlikely that actual PCT for fluopyram will exceed the estimated PCT for

new uses during the next five years.

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III. PROJECTIONS BASED ON MARKET LEADER APPROACH

BEAD used the market leader approach to derive the PCTn values presented in Table 1.

The market leader approach utilizes PCT data for the chemicals that dominate the market to

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 over that same period. BEAD found that

over 95% ofthe time, the new pesticide or new use of a registered pesticide is not likely to

overtake the market leader for 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 leader PCT values. The PCTn value to be used in acute risk assessments

is the highest value among the available years of PCT data.

BEAD previously provided data for 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 sugar beets 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 of DCS PPCT Estimates and Analysis of Rotational Crop PCT

Methodology Submitted by DeS

To evaluate the BCS PPCT estimates BEAD reviewed the most recent NASS data where

available for all crops. When NASS data were unavailable, the most recent proprietary data were

used. The methods differ in terms of data sources and years of usage data. BCS used the

average ofthe highest competitor values from the last five years (2005':'2009) of proprietary 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 sugar beets, where

BEAD used the most recent proprietary data due 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

Sugar beets" TetraconazolelPyraclostrobin 48 46 -4

Watermelon" Chlorothalonil 54 59 9

• a Propnetary data (2006-2010)

• b NASS data (2002-2006)

In order to 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 of dry 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 order to 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 on both 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 of dry beans and potatoes by

the percent of acreage treated for each ofthese two crops. The PCTn for these rotational crops

that follows the treated acreage of dry beans and potatoes, as shown in Table 4, is derived by

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dividing this fixed value (808,000 planted acres from dry beans and potatoes) by the five-year

average of each individual rotational crop's planted acreage as shown in Table 3.

As BCS explains in their Revised Portfolio submission (Bayer, 2011) "for most crops permitted

rotation have been limited to primary crops for which rotational crop data are available (cotton

and alfalfa). Dry beans and potatoes require additional plant back options to canola, com,

cereals, and soybeans. The plant back statements on the product labels have been modified to

reflect these limitations on crop rotations."

In the absence ofsufficient rotational 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 100 percent 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 of Planted 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)

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Table 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 of a

newly registered chemical or a new use will exceed the PCT for new uses: (l) the extent of pest

pressure on the crops in question; (2) the pest spectrum ofthe new pesticide in comparison with

the market leaders as well as whether the 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 of FIFRA are a good indicator in regard to these situations. On the

other hand, it would be relatively difficult for a new active ingredient to gain a large portion of

the market if a) it competes with the market leader(s) or others that have been extensively used

for pest control including the same target pest(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.

Fluopyram belongs to a chemical group functioning as a succinate dehydrogenase

inhibitor (SDHI) and is labeled for use on a variety of crops. HED requested fluopyram PCTn

for 10 crops at this time: almonds, dry beans, peanuts, potatoes, sugar beets, and five cucurbits.

A biological analysis of additional 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).

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Table 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 (Sphaeotheca fuliginea, Podosphaera xanthii, Erysiphe

WATERMELON) cichoracearum)

Alternaria blight (Alternaria spp.); Alternaria leafspot

DRIED BEANS (Alternaria alternate); Gray mold (Botrytis cinerea); Powdery

mildew (Erysiphe pisiy; White mold (Sclerotinia sclerotiorum)

PEANUT Early leafspot (Cercospora arach idicolay ; 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 of dry beans and potatoes, 100%

ofthe acreage treated with fluopyram is assumed to grow these 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 Exemption has been currently issued

for the use of any 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 of action,

where fluopyram has a single-site mode of action.

• Resistance: The Fungicide Resistance Action Committee (FRAC) indicates that

chlorothalonil and sulfur, the market leaders on cantaloupe, cucumber, pumpkin, squash,

and watermelon are generally considered to be at low risk for resistance development.

Triflumizole, one oftwo market leaders on cantaloupe, is a high-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

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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 of action, 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 of any fungicides to control the labeled diseases on dry beans.

• Pest spectrum: The market leader fungicides, thiophanate-methyl and/or pyraclostrobin,

have been registered to control the same target diseases as fluopyram on dry beans.

• Resistance: FRAC indicates that pyraclostrobin 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

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 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 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 of action, which would limit its use and usage.

PEANUT - The market leaders are chlorothalonil and mancozeb.

• Pest pressure: No FIFRA Section 18 Emergency Exemption has been currently issued

for the use of any 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 of action that have been registered 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 of action, 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 of any fungicides to control the labeled diseases on potatoes.

• Pest spectrum: The market leader fungicides, chlorothalonil and/or mancozeb, have been

registered to control the same target diseases as fluopyram on potatoes. Both ofthem are

broad-spectrum fungicides with a multi-site mode of action.

• 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 unlikely that 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 of action, which would limit its use and usage.

SUGAR BEETS - The market leaders are pyraclostrobin and tetraconazole.

• Pest pressure: No FIFRA Section 18 Emergency Exemption has been currently issued

for the use of any fungicides to control the labeled diseases on sugar beets.

• Pest spectrum: The market leader fungicides, pyraclostrobin and/or tetraconazole, have

been registered to control the same target diseases as fluopyram on sugar beets.

• 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 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

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 high risk 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 of action, 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 for plant 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

Alsadek J., 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; Barbara Madden; Paula Deschamp

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