Fluopyram Dietary Exposure and Risk Assessment DP Number: 389122

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

MEMORANDUM

DATE: September 29, 2011

SUBJECT: Fluopyram: Acute, Chronic, and Cancer Aggregate Dietary Exposure and Risk 

Assessments for Section 3 Registration for Use on Apple, Banana (Import only), 

Dried Beans, Cherry, Grape (Wine Production only), Peanut, Pistachio, Potato, 

Sugar Beet, Strawberry, Tree Nuts Crop Group 14, Watermelon, and Rotational 

Crops Alfalfa, Canola, Cotton, Cereal Grains (Except Rice) Crop Group 15, and 

Forage of Cereal Grains (Except Rice) Crop Group 16.

PC Code: 080302 DP Barcode: D389122

Decision No.: 402628 Registration No.: 264-RNTI

Petition No.: 8F7463 Regulatory Action: Section 3 Registration

Risk Assessment Type: Single chemical Case No.: NA

TXR No.: NA CAS No.: 658066-35-4

MRID No.: NA 40 CFR: 180.XXX

REVIEWER: Leung Cheng, Chemist

Risk Assessment Branch III

Health Effects Division (7509P)

THROUGH: Dennis McNeilly, Chemist

David Hrdy, Biologist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

Paula Deschamp, Branch Chief

Risk Assessment Branch III

Health Effects Division (7509P)

TO: Sheila Healy, Risk Assessor

Risk Assessment Branch III

Health Effects Division (7509P)

Executive Summary

Acute, chronic, and cancer aggregate dietary exposure and risk assessments were conducted using 

the Dietary Exposure Evaluation Model (DEEM-FCIDTM), Version 2.03, which uses food 
Fluopyram Dietary Exposure and Risk Assessment DP Number: 389122

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consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes 

by Individuals (CSFII) from 1994-1996 and 1998. The analyses were performed as part of a

registration action to support a petition for new uses of fluopyram on apple, banana (import only),

cherry, dried beans, wine grape, peanut, pistachio, potato, sugar beet, strawberry, tree nuts Crop 

Group 14, and watermelon.

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization

The acute dietary analysis included tolerance residue levels, 100% crop treated assumption and 

processing factors (empirical and default). Estimated drinking water concentration (EDWCs) was 

incorporated directly into the dietary assessment (1 in 10 yr annual peak of 13μg/L) and was 

calculated based on a maximum application rate of 0.446 lb ai/A/season (cucumber).

Estimated acute dietary exposure to fluopyram from food and drinking water is below HED’s level 

of concern for all population subgroups (<100% (aPAD) acute Population Adjusted Dose). 

Combined dietary exposure from food and drinking water at the 95

th percentile of exposure is 

estimated to be 0.021 mg/kg/day for the overall U.S. population, equivalent to 4.2% of the aPAD. 

The population subgroup with the highest estimated acute dietary exposure to fluopyram is 

children 1-2 years, with an estimated exposure at the 95th percentile of 0.042 mg/kg/day, 

equivalent to 8.4% of the aPAD.

Chronic (Food and Drinking Water) Exposure Results and Characterization

The chronic dietary analysis used average residue levels, 100% crop treated assumption, and 

processing factors (empirical and default). Estimated drinking water concentration (EDWCs) was 

incorporated directly into the dietary assessment (1 in 10 yr annual mean of 4.9 μg/L) and was 

calculated based on a maximum application rate of 0.356 lb ai/A/season (potato).

Chronic dietary exposure estimates for food and drinking water are well below HED’s level of 

concern (<100% (cPAD) chronic Population Adjusted Dose) for all population subgroups. The 

dietary exposure is estimated at 0.00042 mg/kg/day for the general U.S. population (3.5% of the 

cPAD) and 0.0012 mg/kg/day (10% of the cPAD) for children 1-2 year olds, the population 

subgroup with the highest estimated chronic dietary exposure to fluopyram. 

Cancer Aggregate Exposure Results and Characterization

The HED Cancer Peer Review Committee (CARC) classified fluopyram as “Likely to be 

Carcinogenic to Human” and recommended the use of linear low dose extrapolation model for risk 

assessment using a unit risk, Q1* = 1.55x10-2(mg/kg/day) -1. The cancer dietary analysis included 

average residue levels, projected percent crop treated (PPCT) estimates and processing factors

(empirical and default). Estimated drinking water concentration (EDWCs) was incorporated 

directly into the dietary assessment (1 in 30 yr annual mean of 3.5 μg/L) and was calculated based 

on a maximum application rate of 0.356 lb ai/A/season (potato). The cancer dietary (food and 

drinking water) risk estimate for the general U.S. population is 2.9 x 10-6 . 
Fluopyram Dietary Exposure and Risk Assessment DP Number: 389122

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I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute 

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., 

the dose which HED has concluded will result in no unreasonable adverse health effects). This 

dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the point of 

departure (POD; e.g., NOAEL, LOAEL) divided by the appropriate uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in 

more detail are available on the EPA/pesticides web site: “Available Information on Assessing 

Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link: 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (8/20/99).

The petition represents the first food use for fluopyram (D387587, D389081 & September 23,

2011, L. Cheng), and thus there are no prior dietary exposure analyses conducted.

II. Food Residue Information

Residues of Concern: The nature of the residue in plants is adequately understood based on 

metabolism studies with grape, potato, bean, and red pepper. HED has determined that the residue 

of concern in plant commodities (primary and rotational crop) for tolerance enforcement is 

fluopyram, and for risk assessment is fluopyram in all crops except in legumes and oilseed crops 

when AE C656948-benzamide is also included. 

The nature of the residue in livestock is adequately understood based on metabolism studies with 

goats and hens. For tolerance enforcement, HED has determined that the residues of concern are 

fluopyram and AE C656948-benzamide. For risk assessment, the residues of concern in ruminants 

are fluopyram and its metabolites AE C656948-benzamide, AE C656948-E-olefine, AE C656948-

Z-olefine and AE C656948-7-hydroxy, and in hens are fluopyram and its metabolites AE 

C656948-benzamide, AE C656948-E-olefine, and AE C656948-Z-olefine.

Tolerances/MRLs: Permanent tolerances are recommendeded in/on the following

commodities:

Almond, hull ..........................................................................................................................8.0 ppm

Apple....................................................................................................................................0.30 ppm

Apple, wet pomace...............................................................................................................0.60 ppm

Banana....................................................................................................................................1.0 ppm

Beans, dry ............................................................................................................................0.09 ppm

Beet, sugar, root ...................................................................................................................0.04 ppm

Cherry ..................................................................................................................................0.60 ppm

Grape, wine ............................................................................................................................2.0 ppm

Nut, tree, group 14 ...............................................................................................................0.05 ppm

Peanut...................................................................................................................................0.02 ppm

Pistachio...............................................................................................................................0.05 ppm

Potato ...................................................................................................................................0.02 ppm

Potato, processed potato waste.............................................................................................0.08 ppm
Fluopyram Dietary Exposure and Risk Assessment DP Number: 389122

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Strawberry..............................................................................................................................1.5 ppm

Watermelon............................................................................................................................1.0 ppm

Cattle, fat..............................................................................................................................0.11 ppm

Cattle, meat ..........................................................................................................................0.15 ppm

Cattle, meat byproducts..........................................................................................................1.1 ppm

Egg .......................................................................................................................................0.25 ppm

Goat, fat................................................................................................................................0.11 ppm

Goat, meat............................................................................................................................0.15 ppm

Goat, meat byproducts ...........................................................................................................1.1 ppm

Hog, fat ................................................................................................................................0.05 ppm

Hog, meat.............................................................................................................................0.05 ppm

Hog, meat byproducts ..........................................................................................................0.70 ppm

Horse, fat..............................................................................................................................0.11 ppm

Horse, meat ..........................................................................................................................0.15 ppm

Horse, meat byproducts..........................................................................................................1.1 ppm

Milk......................................................................................................................................0.07 ppm

Poultry, fat............................................................................................................................0.20 ppm

Poultry, meat ........................................................................................................................0.15 ppm

Poultry, meat byproducts .....................................................................................................0.60 ppm

Sheep, fat..............................................................................................................................0.11 ppm

Sheep, meat ..........................................................................................................................0.15 ppm

Sheep, meat byproducts .........................................................................................................1.1 ppm

In addition, the following rotational crop tolerances are recommended:

Alfalfa, forage ......................................................................................................................0.45 ppm

Alfalfa, hay ............................................................................................................................1.1 ppm

Canola, seed ...........................................................................................................................1.8 ppm

Cotton, gin byproducts.........................................................................................................0.05 ppm

Cotton, undelinted seed........................................................................................................0.01 ppm

Grain, cereal, group 15, except rice .......................................................................................1.5 ppm

Grain, cereal, forage, fodder and straw, group 16, except rice; forage ..................................4.0 ppm

Grain, cereal, forage, fodder and straw, group 16, except rice; hay, straw and stover...........7.0 ppm

Soybean, forage......................................................................................................................4.0 ppm

Soybean, hay ...........................................................................................................................15 ppm

Soybean, seed.......................................................................................................................0.10 ppm

Residue Data used for the Acute and Chronic Assessments: 

For the acute dietary analysis: included tolerance residue levels, 100% crop treated assumption and 

processing factors (empirical and default). The EDWC was incorporated directly into the dietary

assessment (1 in 10 yr annual peak of 13μg/L).

For the chronic non-cancer dietary analysis: average residues, 100%CT and processing factors

(empirical and default) were used. The EDWC was incorporated directly into the dietary

assessment (1 in 10 yr annual mean of 4.9 μg/L).

For the cancer dietary assessment: average residues, projected percent crop treated, and empirical 

and default processing factors were used. The EDWC was incorporated directly into the dietary

assessment (1 in 30 yr annual mean of 3.5μg/L).

Percent Crop Treated:
Fluopyram Dietary Exposure and Risk Assessment DP Number: 389122

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Projected %CT data (J. Alsadek and C. Chen, 5/23/2011) were used to refine anticipated residues 

for the cancer assessment. To calculate these projected percent crop treated values, BEAD used 

recent data from the National Statistics Service (NASS) 2002-2006, and recent proprietary data 

(2006-2010). The estimates for the primary crops are based on the market leader approach 

involving several registered fungicides, and the estimates for the rotational crops are based on the 

total acreage available from treated rotatable crops (dry beans and potato); see Attachment 9. 

Livestock commodities: 

There are livestock feedstuffs associated with the proposed uses of fluopyram, and the following 

ones are considered important: alfalfa hay, alfalfa meal, almond hulls, canola meal, field/sweet 

corn forage/silage, sorghum grain, sugar beet molasses, and wheat milled byproducts (email, J. 

Stokes, 5/16/2011). The estimated dietary burdens for tolerance setting are 1.90 ppm for beef 

cattle, 3.39 ppm for dairy cattle, 1.24 ppm for poultry, and 1.33 ppm for swine (see D387587, 

September 23, 2011, L. Cheng). For chronic dietary assessments, the livestock dietary burdens are 

adjusted with projected percent crop treated estimates provided by BEAD (see Attachment 2). 

III. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the 

Environmental Fate and Effects Division (M. Ruhman, 7/8/2011), DP Barcodes 353319, 363812, 

363820, 363821, 363822, 363824, and 369773) and incorporated directly into this dietary

assessment. Water residues were incorporated in the DEEM-FCID into the food categories “water, 

direct, all sources” and “water, indirect, all sources.”

The residue of concern in drinking water for this single chemical risk assessment is fluopyram 

(Residues Of Concern Knowledgebase Subcommittee, D367115, 7/16/2009). The Environmental 

Fate and Effects Division (EFED) calculated screening level surface water and ground water 

estimates for fluopyram using PRZM/EXAMS models and the SCI-GROW model, respectively.

The drinking water models and their descriptions are available at the EPA internet site: 

http://www.epa.gov/oppefed1/models/water/. 

The EDWCs for fluopyram were calculated for ground and surface drinking water using the Tier II 

(PRZM/EXAMS) surface water modeling and Tier I (SCI-GROW) ground water modeling based 

on the proposed maximum use rates of fluopyram on Florida cucumber scenario and Maine potato 

scenario. The surface water estimates are 13.0 μg/L for acute concentration (1-in-10 year annual 

peak), 4.90 μg/L for chronic concentration (1-in-10 year mean), and 3.49 μg/L for cancer 

concentration (30-year annual mean). The SCI-GROW model estimated a concentration of 0.319

μg fluopyram/L in ground water. Surface water EDWCs were used in the dietary assessment, 

since they were higher than those for ground water. For the human health risk assessment, the 

highest relevant EDWCs are recommended.
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IV. DEEM-FCIDTM Program and Consumption Information

Fluopyram acute and chronic dietary exposure assessments were conducted using the Dietary

Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM, 

Version 2.03), which incorporates consumption data from USDA’s CSFII, 1994-1996 and 1998. 

The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over 

two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPAdefined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour -

cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by

USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the 

entire U.S. population and within population subgroups, but for acute exposure assessment are 

retained as individual consumption events. Based on analysis of the 1994-96, 98 CSFII 

consumption data, which took into account dietary patterns and survey respondents, HED 

concluded that it is most appropriate to report risk for the following population subgroups: the 

general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth

13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessments, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average 

daily consumption estimate for that food/food form to produce a residue intake estimate. The 

resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total average 

estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the 

cPAD. This procedure is performed for each population subgroup.

For cancer dietary exposure assessments, the estimated exposure of the general U.S. population is 

multiplied by the Q1*.

For acute exposure assessments, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food item can be 

multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a 

deterministic exposure assessment, or “matched” in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant 

commodities/food forms) and a per-capita (i.e., those who reported eating the relevant 

commodities as well as those who did not) basis. In accordance with HED policy, per capita 

exposure and risk are reported for all tiers of analysis. However, for highly refined assessments,

any significant differences in user vs. per capita exposure and risk are specifically identified and 

noted in the risk assessment.

V. Toxicological Information 

The fluopyram risk assessment team selected a rat acute neurotoxicity study and rat combined 

chronic/carcinogenicity study, which provided the most sensitive and protective endpoints from 

the fluopyram database, to employ in the risk assessment for acute and chronic dietary exposure 

scenarios (TOXSAC memo,12/23/2009). The doses and toxicological endpoints selected for 
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dietary risk assessment are summarized in Table 1.

Table 1. Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Dietary Human Health Risk 

Assessments

Exposure/

Scenario

Point of 

Departure

Uncertainty/

FQPA Safety 

Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological Effects

Acute Dietary 

(General 

Population, 

including 

Infants and 

Children)

NOAEL= 50

mg/kg/day

UFA= 10 x

UFH=10 x

FQPA SF=1x

Acute RfD = 0.50 

mg/kg/day

aPAD = 0.50 

mg/kg/day

Acute Neurotoxicity Study in Rats. 

The LOAEL of 100 mg/kg in females is 

based on decreased motor and locomotor 

activity in females. The LOAEL in males 

was 125 mg/kg/day.

Acute Dietary

(Females 13-

49 years of 

age)

An endpoint attributable to a single dose exposure has not been identified for subpopulation.

Chronic 

Dietary (All 

Populations)

NOAEL= 1.2

mg/kg/day

UFA= 10 x

UFH=10 x

FQPA SF=1x

Chronic RfD = 

0.012

mg/kg/day

cPAD = 0.012

mg/kg/day

Combined Chronic/Carcinogenicity in Rats.

The LOAEL of 6.0 mg/kg/day is based on 

nephropathy in the kidney, follicular cell 

hypertrophy in the thyroid, and increased 

liver weight with gross pathological and 

histopathological findings.

Cancer (oral, 

dermal, 

inhalation)

Based on the liver tumor in female rats and thyroid tumor in male rats, the CARC classified fluopyram as a 

“Likely to be Carcinogenic to Human” and recommended the use of linear low dose extrapolation model for 

risk assessment using a unit risk, Q1

*

=1.55x10-2(mg/kg/day)-1

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and 

used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human 

exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = 

uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity 

among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population 

adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

N/A = not applicable.

VI. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure of the U.S. 

population and various population subgroups. The acute and chronic results reported in Tables 2

and 3 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, 

children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years. 

Results of Acute Dietary Exposure Analysis

Estimated acute dietary exposure to fluopyram from food and drinking water is below HED’s level 

of concern for all population subgroups. Combined dietary exposure from food and drinking water 

at the 95th percentile of exposure is estimated to be 0.021 mg/kg/day for the overall U.S. 

population, equivalent to 4.2% of the aPAD. The population subgroup with the highest estimated 

acute dietary exposure to fluopyram is children 1-2 yrs, with an estimated exposure at the 95th

percentile of 0.042 mg/kg/day, equivalent to 8.4% of the aPAD. When comparing the per capita to 

per user exposures, no significant differences were found for all population subgroups. The results 
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for all populations at the 95th, 99th, and 99.9th percentiles of exposure are summarized in the Table 

2 below.

Table 2. Results of Acute Dietary (Food + Drinking Water) Exposure Analysis Using DEEM-FCID 

Population 

Subgroup

aPAD 

(mg/kg/day)

95th Percentile 99th Percentile 99.9th Percentile

Exposure 

(mg/kg/day)

% aPAD Exposure 

(mg/kg/day)

% aPAD Exposure

(mg/kg/day)

% aPAD

General U.S. 

Population

0.50

0.020741 4.2 0.033456 6.7 0.054800 11

All Infants 

(< 1 year old)

0.038195 7.6 0.063671 13 0.112337 22

Children 1-2 

years old 0.042156 8.4 0.054792 11 0.078116 16

Children 3-5 

years old 0.035136 7.0 0.047878 9.6 0.073838 15

Children 6-12 

years old 0.024081 4.8 0.035065 7.0 0.054834 11

Youth 13-19 

years old 0.015398 3.1 0.024207 4.8 0.037645 7.5

Adults 20-49 

years old 0.013032 2.6 0.019434 3.9 0.032439 6.5

Adults 50+ 

years old 0.011141 2.2 0.017676 3.5 0.031026 6.2

Females 13-49 

years old 0.012844 2.6 0.019692 3.9 0.032515 6.5

Results of Chronic Dietary Exposure Analysis

The results of the aggregate chronic dietary analysis for food and drinking water are below the 

Agency’s level of concern (<100% cPAD) for all population subgroups. Chronic dietary exposure 

was estimated at 0.00042 mg/kg/day for the U.S. population (3.5% of the cPAD) and 0.0012

mg/kg/day (10% of the cPAD) for the most highly exposed population subgroup (children 1-2 yrs

old). 

Based on a Q1* = 1.55x10-2(mg/kg/day) -1, the cancer risk was estimated at 2.9 x10-6 with 

exposure from drinking water accounted for 1.1 x10-6. The estimated chronic exposures/risks for 

food and water are summarized in Table 3 for all populations.
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Table 3. Summary of Chronic Dietary (Food and Drinking Water) Exposure and Risk for Fluopyram

Population Subgroup

cPAD 

(mg/kg/day)

Chronic Dietary Cancer

Dietary 

Exposure 

(mg/kg/day)

%

cPAD

Dietary 

Exposure

(mg/kg/day)

Risk

Q* = 1.55 x 10-2

General U.S. Population 0.0120.000423 3.5 0.000188 2.9 x 10-6

All Infants (< 1 year old) 0.000800 6.7

NA2 NA

Children 1-2 years old 0.001239 10

Children 3-5 years old 0.001017 8.5

Children 6-12 years old 0.000574 4.8

Youth 13-19 years old 0.000315 2.6

Adults 20-49 years old 0.000320 2.7

Adults 50+ years old 0.000353 2.9

Females 13-49 years old 0.000326 2.7

1The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and risk is 

indicated by bold text.

2NA = not applicable

VII. Characterization of Inputs/Outputs

The acute dietary risk assessment is considered not refined. The acute analysis was conducted 

using tolerance level residues for all commodities and the residue levels were derived from field 

trial data conducted at the maximum application rate and minimum PHI permitted on the proposed 

label. The chronic dietary risk assessment is considered partially refined and cancer dietary risk 

assessment is highly refined. Anticipated residues for all the proposed food commodities were 

based on field trial data. Although field trial data provide more refined exposure estimates than 

tolerances, the results may still be considered somewhat conservative, since field trials are 

conducted under maximum use conditions (maximum allowed application rate and number of 

applications, minimum PHI, etc.). 

A number of experimentally derived processing factors were used to refine the chronic analyses. 

Default DEEM processing factors were incorporated for all other processed commodities. 

 
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 VIII. Conclusions

For acute assessment, food and drinking water are below HED’s level of concern (<100% aPAD) 

at the 95th percentile of exposure. Combined dietary exposure from food and drinking water is 

estimated to be 0.021 mg/kg/day for the overall U.S. population, equivalent to 4.2% of the aPAD. 

The population subgroup with the highest estimated acute dietary exposure to is children 1-2 years

old, with an estimated exposure at the 95th percentile of 0.042 mg/kg/day, equivalent to 8.4% of 

the aPAD.

Chronic dietary exposure estimates for food and water are well below HED’s level of concern 

(<100% cPAD) for all population subgroups. The dietary exposure is estimated at 0.00042

mg/kg/day for the general U.S. population (3.5% of the cPAD) and 0.0012 mg/kg/day (10% of the 

cPAD) for children 1-2 years old, the population subgroup with the highest estimated chronic 

dietary exposure to fluopyram. 

The cancer dietary exposure for the U.S. general population is estimated at 2.9 x 10-6 .

IX. List of Attachments

Attachment 1. Data and Residue Estimates Used in Dietary Analyses

Attachment 2. Livestock Dietary Burdens for Chronic Analysis

Attachment 3. Acute Dietary Analysis Input File - Food & Water

Attachment 4. Acute Dietary Analysis Results - Food & Water

Attachment 5. Chronic Dietary Analysis Input File - Food & Water

Attachment 6. Chronic Dietary Analysis Results - Food & Water

Attachment 7. Cancer Dietary Analysis Input File - Food & Water

Attachment 8. Cancer Dietary Analysis Results - Food & Water

Attachment 9. BEAD Projected Percent Crop Treated Memo (5/23/2011)
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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11

Attachment 1. Data and Residue Estimates Used in Dietary Analyses

Data and Residue Estimates Used in Dietary Analyses

RAC Classification1

Data

Source

No. of

Samples

No. of

Detectable

Residues LOQ %CT

Processing

Factors

Anticipated Residue 

Estimates/Tolerance

Acute (Tol., HR, 

HAFT, RDF) 2

Chronic (Tol., 

AR)2

Almond

Almond oil

Almond hulls

PB

B

PB

Field Trial Data 

47567020 20

4

4

20

0.01 33

0.05 (Tol)

0.05 (Tol)

8.0 (Tol)

0.01 (AR)

0.01 (AR)

3.08 (AR)

Apple NB, PB Field Trial Data 

47567032 58 58 0.01 40

Washed 0.7x

Peeled 0.03x

Dried 0.03x

Juice 0.4x

Applesauce 0.01x

47567111

0.30 (Tol) 0.11 (AR)

Banana NB, PB Field Trial Data 

47567036 28 28 0.01 1.0 (Tol) 0.02 (AR)

Barley B

Wheat Field Trial 

Data 47567015 30 30 0.01 22 1.5 (Tol) 0.22 (AR)
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Data and Residue Estimates Used in Dietary Analyses

RAC Classification1

Data

Source

No. of

Samples

No. of

Detectable

Residues LOQ %CT

Processing

Factors

Anticipated Residue 

Estimates/Tolerance

Acute (Tol., HR, 

HAFT, RDF) 2

Chronic (Tol., 

AR)2

Bean, dry

Bean, black, seed

Bean, broad, seed

Bean, cowpea, 

seed

Bean, great 

northern, seed

Bean, kidney, 

seed

Bean, lima, seed

Bean, mung, seed

Bean, navy, seed

Bean, pink, seed

Bean, pinto, seed

B

Dry Bean Seed 

Field Trial Data 

47567029

18 11 0.01 7 0.09 (Tol) 0.01 (AR)

The benzamide to fluopyram ratio from the bean metabolism study is 5.1x. Thus, the parent residues in dry beans are adjusted with a 6.1x factor for acute and chronic

Beet, sugar B

Field Trial Data 

47567010 24 24 0.01 48

Refined sugar 1.3x

Molasses 0.9x

47567120

0.04 (Tol) 0.01 (AR)

Brazil nut PB Pecan Field Trial 

Data 47567020 20 4 0.01 0.05 (Tol) 0.01 (AR)

Buck wheat B

Wheat Field Trial 

Data 47567015 30 30 0.01 1.5 (Tol) 0.22 (AR)

Butternut PB Pecan Field Trial 

Data 47567020 20 4 0.01 0.05 (Tol) 0.01 (AR)
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

13

Data and Residue Estimates Used in Dietary Analyses

RAC Classification1

Data

Source

No. of

Samples

No. of

Detectable

Residues LOQ %CT

Processing

Factors

Anticipated Residue 

Estimates/Tolerance

Acute (Tol., HR, 

HAFT, RDF) 2

Chronic (Tol., 

AR)2

Cashew PB Pecan Field Trial 

Data 47567020 20 4 0.01 0.05 (Tol) 0.01 (AR)

Cherry PB Field Trial Data 

47567033 12 12 0.01 49 0.60 (Tol) 0.19 (AR)

Chestnut PB

Almond Field 

Trial Data 

47567020

20 4 0.01 0.05 (Tol) 0.01 (AR)

Chickpea B

Dry Bean Seed 

Field Trial Data 

47567029

18 11 0.01 7 0.09 (Tol)

0.01 (AR) - see 

note under dry 

beans

Corn, field

Corn, pop

Corn, sweet

B

Field Trial Data 

47567014

30

18

2

0

0.01

1

Bran 2.64x

Flour 0.85x

Meal 0.8x

Refined oil 0.59x, 0.11x 

(aver = 0.35x)

Starch 0.15x

47567117

1.5 (Tol)

Field & pop 

corn 0.01 (AR)

Sweet corn 

0.005 (AR)

Cottonseed B

Field Trial Data 

47567125 22 0 0.01 7

<0.01 ppm from 5x use 

rate

47567122

Refined oil 0.01x

(rapeseed oil processing 

data in 47567116)

0.01 (Tol) 0.01 (AR)

The EU canola field trials show that the maximum benzamide residues compared to fluopyram represented 50%. Thus, the parent residues in cottonseed are adjusted by 1.5 for 

acute and chronic
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

14

Data and Residue Estimates Used in Dietary Analyses

RAC Classification1

Data

Source

No. of

Samples

No. of

Detectable

Residues LOQ %CT

Processing

Factors

Anticipated Residue 

Estimates/Tolerance

Acute (Tol., HR, 

HAFT, RDF) 2

Chronic (Tol., 

AR)2

Filbert PB Pecan Field Trial 

Data 47567020 20 4 0.01 0.05 (Tol) 0.01 (AR)

Grape, wine PB Field Trial Data 

47372604 32 32 0.01 79

Juice 0.5x 

Raisins 2.4x

Washed 0.8x

2.0 (Tol) 0.40 (AR)

Guar seed B

Dry Bean Seed 

Field Trial Data 

47567029

18 11 0.01 7 0.09 (Tol)

0.01 (AR) - see 

note under dry 

beans

Hickory nut PB Pecan Field Trial 

Data 47567020 20 4 0.01 0.05 (Tol) 0.01 (AR)

Lentil B

Dry Bean Seed 

Field Trial Data 

47567029

18 11 0.01 7 0.09 (Tol)

0.01 (AR) -

see note under 

dry beans

Macademia nut PB Pecan Field Trial 

Data 47567020 20 4 0.01 0.05 (Tol) 0.01 (AR)

Millet B

Sorghum Field 

Trial Data 

47567015

24 24 0.01 1.5 (Tol) 0.62 (AR)

Oat B

Wheat Field Trial 

Data 47567015 30 30 0.01 23 1.5 (Tol) 0.22 (AR)

Peanut B

Field Trial Data 

47567019 24 4 0.01 67

Butter 0.22x

Meal 0.19x

Refined oil 0.25x

Roasted 0.26x

47567114

0.02 (Tol) 0.011 (AR)
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

15

Data and Residue Estimates Used in Dietary Analyses

RAC Classification1

Data

Source

No. of

Samples

No. of

Detectable

Residues LOQ %CT

Processing

Factors

Anticipated Residue 

Estimates/Tolerance

Acute (Tol., HR, 

HAFT, RDF) 2

Chronic (Tol., 

AR)2

Pecan PB Field Trial Data 

47567020 20 4 0.01 0.05 (Tol) 0.01 (AR)

Pistachio PB

Almond Field 

Trial Data 

47567020

20 4 0.01 0.05 (Tol) 0.01 (AR)

Potato NB, PB Field Trial Data 

47567012 32 2 0.01 64

Peeled tubers 0.2x

Washed tubers 0.7x

Potato chips 0.3x

Granules/flakes 1x

47567118

0.02 (Tol) 0.01 (AR)

Rape seed 

oil/canola oil B

Field Trial Data 

47567013 16 16 0.01 73

Canola meal 0.3x

Refined oil 0.01x

47567116

1.8 (Tol) 0.51 (AR)

The EU canola field trials show that the maximum benzamide residues compared to fluopyram represented 50%. Thus, the parent residues in canola/rapeseed are adjusted by 1.5 

for acute and chronic

Rye B

Wheat Field Trial 

Data 47567015 30 30 0.01 63 1.5 (Tol) 0.22 (AR)

Sorghum B

Field Trial Data 

47567015 24 24 0.01 12 1.5 (Tol) 0.62 (AR)

Soybean B

Field Trial Data 

47567016 40 15 0.01 1

Flour 0.04x

Meal 0.05x

Milk 0.01x

Refined oil 0.02x

47567119

0.10 (Tol) 0.024 (AR)
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

16

Data and Residue Estimates Used in Dietary Analyses

RAC Classification1

Data

Source

No. of

Samples

No. of

Detectable

Residues LOQ %CT

Processing

Factors

Anticipated Residue 

Estimates/Tolerance

Acute (Tol., HR, 

HAFT, RDF) 2

Chronic (Tol., 

AR)2

Strawberry PB

Field Trial Data 

47372605

47372615 (EU 

greenhouse)

20 (drip)

8 (green 

house)

8

8

0.01 71 1.5 (Tol)

0.026 (AR)

0.35 (AR)

Ave = 0.19

Triticale B

Wheat Field Trial 

Data 47567015 30 30 0.01 Flour 0.12x 1.5 (Tol) 0.22 (AR)

Walnut PB Pecan Field Trial 

Data 47567020 20 4 0.01 0.05 (Tol) 0.01 (AR)

Watermelon NB, PB

Muskmelon Field 

Trial Data 

47567030

12 12 0.01 54 Peeled 0.044x (from 

foliar treatment) 1.0 (Tol) 0.22 (AR)

Wheat B

Field Trial Data 

47567015 30 30 0.01 1

Wheat flour 0.12x

Wheat germ 2.4x

Wheat bran 2.7x

47567115

1.5 (Tol) 0.22 (AR)

Water N/A Modeling N/A N/A N/A N/A N/A 0.013 0.0049 (0.0035 

for cancer)

For risk assessment in livestock commodities, metabolites 7-hydroxy and the 2 olefins need to be included; and in poultry commodities, the 2 olefin metabolites need to be 

included. Based on the goat metabolism data (phenyl label), the ratios of the sum of parent, benzamide, 7-hydroxy, and the olefins to the sum of parent and benzamide are 1.02 

in milk, 1.00 in meat, 1.43 in fat, 1.02 in liver, and 1.01 in kidney. Therefore, for fat commodities in the acute assessment, an adjustment factor of 1.43 has been applied. 

Based on the poultry metabolism data (phenyl label), the ratios of the sum of parent, benzamide, and the olefins to the sum of parent and benzamide are 1.01 in egg, 1.01 in meat, 

1.39 in fat, and 1.01 in liver. Therefore, for fat commodities in the acute assessment, an adjustment factor of 1.39 has been applied.

See charts below for residue estimates for chronic dietary assessment.

Meat (except 

pork) 0.15 (Tol) 0.0007 (AR)
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

17

Data and Residue Estimates Used in Dietary Analyses

RAC Classification1

Data

Source

No. of

Samples

No. of

Detectable

Residues LOQ %CT

Processing

Factors

Anticipated Residue 

Estimates/Tolerance

Acute (Tol., HR, 

HAFT, RDF) 2

Chronic (Tol., 

AR)2

Meat byproducts 

(except pork) 1.1 (Tol) 0.0011 (AR)

Fat (except pork) 0.11 (Tol) 0.0004 (AR)

Kidney (except 

pork) 1.1 (Tol) 0.0011 (AR)

Liver (except 

pork) 1.1 (Tol) 0.0069 (AR)

Chicken meat 0.15 (Tol) 0.014 (AR)

Chicken liver 0.60 (Tol) 0.022 (AR)

Chicken meat 

byproducts 0.60 (Tol) 0.014 (AR)

Chicken fat/skin 0.20 (Tol) 0.014 (AR)

Egg 0.25 (Tol) 0.014 (AR)

Milk 0.07 (Tol) 0.0029 (AR)

Pork meat 0.05 (Tol) 0.001 (AR)

Pork skin/fat 0.05 (Tol) 0.0005 (AR)

Pork kidney 0.70 (Tol) 0.0015 (AR)

Pork liver 0.70 (Tol) 0.009 (AR)

N/A = not applicable

1. Classification of blended (B), partially blended (PB), not blended (NB).

2. HR=highest residue; HAFT=highest average field trial value; AR=average residue
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

18

Cattle feeding study maximum residues in ppm parent equivalents at 1.5 ppm feeding level: 

Dairy Milk Fat Liver Muscle Kidney

fluopyram 0.01 <0.01 0.25 <0.01 <0.01

benzamide 0.02 <0.01 0.10 0.02 0.03

7-OH <<0.01/<0.003 <<0.01 0.006 <<0.01 0.003

Olefins (2) <0.02 <0.02 <0.02 <0.02 0.02

Total 0.04 0.02 0.37 0.04 0.06

0.11/1.5 0.0029

LOQ = 0.01 ppm parent, benzamide, 7-hydroxy; 0.02 ppm olefins (E & Z isomers)

Beef Milk Fat Liver Muscle Kidney

fluopyram 0.01 <0.01 0.25 <0.01 <0.01

benzamide 0.02 <0.01 0.10 0.02 0.03

7-OH <<0.01 <<0.01 0.006 <<0.01 0.003

Olefins (2) <0.02 <0.02 <0.02 <0.02 0.02

Total 0.04 0.02 0.37 0.04 0.06

0.028/1.5 0.0004 0.0069 0.0007 0.0011

0.038/1.5 (hog) 0.0005 0.009 0.001 0.0015

Poultry feeding study maximum residues in ppm parent equivalents at 0.05 ppm feeding level: 

Egg Skin with fat Liver Muscle

fluopyram <0.01 <0.01 <0.01 <0.01

benzamide <0.01 <0.01 0.02 <0.01

Olefins (2) <0.02 <0.02 <0.02 <0.02

Total 0.02 0.02 0.03 0.02

0.036/0.05 

(0.72x)

0.014 0.014 0.022 0.014
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

19

Attachment 2. Livestock Dietary Burdens for Chronic Analysis

Calculation of Dietary Burdens of Fluopyram Residues to Livestock for Chronic Dietary Exposure.

Feedstuff Type1 % Dry 

Matter2 % Diet2

Average 

Residue 

(ppm)

PPCT 3

Dietary 

Contribution 

(ppm)4

Beef Cattle: 15% R, 80% CC, 5% PC

Corn, field, forage/silage R 40 15 1.76 1 0.0066

Sorghum, grain, grain CC 86 40 0.31 12 0.0173

Wheat, milled byproducts CC 88 30 0.30 1 0.001

Beet, sugar, molasses CC 75 10 0.021 48 0.0013

Canola, meal PC 88 5 0.075 73 0.0031

TOTAL BURDEN -- -- 100 -- -- 0.028

Dairy Cattle: 45% R, 45% CC, 10% PC

Almond, hulls R 90 5 3.08 43 0.0736

Corn, sweet, forage/silage R 48 40 1.76 1 0.0147

Sorghum, grain, grain CC 86 35 0.31 12 0.0151

Beet, sugar, molasses CC 75 10 0.021 48 0.0013

Canola, meal PC 88 10 0.075 73 0.0062

TOTAL BURDEN -- -- 100 -- -- 0.11

Poultry: 75% CC, 25% PC

Sorghum, grain, grain CC 86 75 0.31 12 0.0279

Canola, meal PC 88 15 0.075 73 0.0082

Alfalfa, meal PC 89 5 0.16 4 0.0003

Untreated PC -- 5 -- --

TOTAL BURDEN -- -- 100 -- -- 0.036

Swine: 85% CC, 15% PC

Sorghum, grain, grain CC 86 80 0.31 12 0.0298

Wheat, milled byproducts CC 88 5 0.30 1 0.0002

Canola, meal PC 88 15 0.075 73 0.0082

TOTAL BURDEN -- -- 100 -- -- 0.038

1

 R: Roughage; CC: Carbohydrate concentrate; PC: Protein concentrate.

2

 OPPTS 860.1000 Table 1 Feedstuffs (June 2008). 

3

 Projected percent crop treated values from BEAD. 

4

 Contribution = ([residue /% DM] X % diet) for beef and dairy cattle; contribution = ([residue] X % diet) for poultry and swine. 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

Page 20 of 40

Attachment 3. Acute Dietary Analysis Input File - Food & Drinking Water

U.S. Environmental Protection Agency Ver. 2.02

DEEM-FCID Acute analysis for FLUOPYRAM

Residue file name: C:\Documents and Settings\lcheng\My Documents\DEEM FCID 

lc\Fluopyram\Tolerance 2011-08-08.R98

Analysis Date 09-23-2011 Residue file dated: 09-23-2011/14:56:51/8

Reference dose (aRfD) = 0.5 mg/kg bw/day

Comment: Tolerance residues 2011-08-08 crops 13 ppb water

--------------------------------------------------------------------------------

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Food Name (ppm) #1 #2 

-------- ---- ------------------------------- ---------- ------ ------ -------

14000030 14 Almond 0.050000 1.000 1.000

14000031 14 Almond-babyfood 0.050000 1.000 1.000

14000040 14 Almond, oil 0.050000 1.000 1.000

14000041 14 Almond, oil-babyfood 0.050000 1.000 1.000

11000070 11 Apple, fruit with peel 0.300000 1.000 1.000

11000080 11 Apple, peeled fruit 0.300000 1.000 1.000

11000081 11 Apple, peeled fruit-babyfood 0.300000 1.000 1.000

11000090 11 Apple, dried 0.300000 1.000 1.000

11000091 11 Apple, dried-babyfood 0.300000 1.000 1.000

11000100 11 Apple, juice 0.300000 1.000 1.000

11000101 11 Apple, juice-babyfood 0.300000 1.000 1.000

11000110 11 Apple, sauce 0.300000 1.000 1.000

11000111 11 Apple, sauce-babyfood 0.300000 1.000 1.000

95000230 O Banana 1.000000 1.000 1.000

95000231 O Banana-babyfood 1.000000 3.900 1.000

95000240 O Banana, dried 1.000000 3.900 1.000

95000241 O Banana, dried-babyfood 1.000000 1.000 1.000

15000250 15 Barley, pearled barley 1.500000 1.000 1.000

15000251 15 Barley, pearled barley-babyfood 1.500000 1.000 1.000

15000260 15 Barley, flour 1.500000 1.000 1.000

15000261 15 Barley, flour-babyfood 1.500000 1.000 1.000

15000270 15 Barley, bran 1.500000 2.700 1.000

06030300 6C Bean, black, seed 0.090000 6.100 1.000

06030320 6C Bean, broad, seed 0.090000 6.100 1.000

06030340 6C Bean, cowpea, seed 0.090000 6.100 1.000

06030350 6C Bean, great northern, seed 0.090000 6.100 1.000

06030360 6C Bean, kidney, seed 0.090000 6.100 1.000

06030380 6C Bean, lima, seed 0.090000 6.100 1.000

06030390 6C Bean, mung, seed 0.090000 6.100 1.000

06030400 6C Bean, navy, seed 0.090000 6.100 1.000

06030410 6C Bean, pink, seed 0.090000 6.100 1.000

06030420 6C Bean, pinto, seed 0.090000 6.100 1.000

21000440 M Beef, meat 0.150000 1.000 1.000

21000441 M Beef, meat-babyfood 0.150000 1.000 1.000

21000450 M Beef, meat, dried 0.150000 1.920 1.000

21000460 M Beef, meat byproducts 1.100000 1.000 1.000

21000461 M Beef, meat byproducts-babyfood 1.100000 1.000 1.000

21000470 M Beef, fat 0.110000 1.430 1.000

21000471 M Beef,fat-babyfood 0.110000 1.430 1.000

21000480 M Beef, kidney 1.100000 1.000 1.000

21000490 M Beef, liver 1.100000 1.000 1.000

21000491 M Beef, liver-babyfood 1.100000 1.000 1.000

01010520 1A Beet, sugar 0.040000 1.300 1.000

01010521 1A Beet, sugar-babyfood 0.040000 1.300 1.000

01010530 1A Beet, sugar, molasses 0.040000 1.000 1.000

01010531 1A Beet, sugar, molasses-babyfood 0.040000 1.000 1.000

14000590 14 Brazil nut 0.050000 1.000 1.000

15000650 15 Buckwheat 1.500000 1.000 1.000

15000660 15 Buckwheat, flour 1.500000 1.000 1.000

14000680 14 Butternut 0.050000 1.000 1.000

14000810 14 Cashew 0.050000 1.000 1.000

12000900 12 Cherry 0.600000 1.000 1.000

12000901 12 Cherry-babyfood 0.600000 1.000 1.000

12000910 12 Cherry, juice 0.600000 1.000 1.000

12000911 12 Cherry, juice-babyfood 0.600000 1.000 1.000
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

Page 21 of 40

14000920 14 Chestnut 0.050000 1.000 1.000

40000930 P Chicken, meat 0.150000 1.000 1.000

40000931 P Chicken, meat-babyfood 0.150000 1.000 1.000

40000940 P Chicken, liver 0.600000 1.000 1.000

40000950 P Chicken, meat byproducts 0.600000 1.000 1.000

40000951 P Chicken, meat byproducts-babyfoo 0.600000 1.000 1.000

40000960 P Chicken, fat 0.200000 1.390 1.000

40000961 P Chicken, fat-babyfood 0.200000 1.390 1.000

40000970 P Chicken, skin 0.200000 1.390 1.000

40000971 P Chicken, skin-babyfood 0.200000 1.390 1.000

06030980 6C Chickpea, seed 0.090000 6.100 1.000

06030981 6C Chickpea, seed-babyfood 0.090000 6.100 1.000

06030990 6C Chickpea, flour 0.090000 6.100 1.000

15001200 15 Corn, field, flour 1.500000 1.000 1.000

15001201 15 Corn, field, flour-babyfood 1.500000 1.000 1.000

15001210 15 Corn, field, meal 1.500000 1.000 1.000

15001211 15 Corn, field, meal-babyfood 1.500000 1.000 1.000

15001220 15 Corn, field, bran 1.500000 2.600 1.000

15001230 15 Corn, field, starch 1.500000 1.000 1.000

15001231 15 Corn, field, starch-babyfood 1.500000 1.000 1.000

15001240 15 Corn, field, syrup 1.500000 1.000 1.000

15001241 15 Corn, field, syrup-babyfood 1.500000 1.000 1.000

15001250 15 Corn, field, oil 1.500000 1.000 1.000

15001251 15 Corn, field, oil-babyfood 1.500000 1.000 1.000

15001260 15 Corn, pop 1.500000 1.000 1.000

15001270 15 Corn, sweet 1.500000 1.000 1.000

15001271 15 Corn, sweet-babyfood 1.500000 1.000 1.000

95001280 O Cottonseed, oil 0.010000 1.500 1.000

95001281 O Cottonseed, oil-babyfood 0.010000 1.500 1.000

70001450 P Egg, whole 0.250000 1.000 1.000

70001451 P Egg, whole-babyfood 0.250000 1.000 1.000

70001460 P Egg, white 0.250000 1.000 1.000

70001461 P Egg, white (solids)-babyfood 0.250000 1.000 1.000

70001470 P Egg, yolk 0.250000 1.000 1.000

70001471 P Egg, yolk-babyfood 0.250000 1.000 1.000

14001550 14 Filbert 0.050000 1.000 1.000

14001560 14 Filbert, oil 0.050000 1.000 1.000

23001690 M Goat, meat 0.150000 1.000 1.000

23001700 M Goat, meat byproducts 1.100000 1.000 1.000

23001710 M Goat, fat 0.110000 1.430 1.000

23001720 M Goat, kidney 1.100000 1.000 1.000

23001730 M Goat, liver 1.100000 1.000 1.000

95001790 O Grape, wine and sherry 2.000000 1.000 1.000

06031820 6C Guar, seed 0.090000 6.100 1.000

06031821 6C Guar, seed-babyfood 0.090000 6.100 1.000

14001850 14 Hickory nut 0.050000 1.000 1.000

24001890 M Horse, meat 0.150000 1.000 1.000

06032030 6C Lentil, seed 0.090000 6.100 1.000

14002130 14 Macadamia nut 0.050000 1.000 1.000

28002210 M Meat, game 0.150000 1.000 1.000

27002220 D Milk, fat 0.070000 1.000 1.000

27002221 D Milk, fat - baby food/infant for 0.070000 1.000 1.000

27012230 D Milk, nonfat solids 0.070000 1.000 1.000

27012231 D Milk, nonfat solids-baby food/in 0.070000 1.000 1.000

27022240 D Milk, water 0.070000 1.000 1.000

27022241 D Milk, water-babyfood/infant form 0.070000 1.000 1.000

27032251 D Milk, sugar (lactose)-baby food/ 0.070000 1.000 1.000

15002260 15 Millet, grain 1.500000 1.000 1.000

15002310 15 Oat, bran 1.500000 2.700 1.000

15002320 15 Oat, flour 1.500000 1.000 1.000

15002321 15 Oat, flour-babyfood 1.500000 1.000 1.000

15002330 15 Oat, groats/rolled oats 1.500000 1.000 1.000

15002331 15 Oat, groats/rolled oats-babyfood 1.500000 1.000 1.000

95002630 O Peanut 0.020000 1.000 1.000

95002640 O Peanut, butter 0.020000 1.000 1.000

95002650 O Peanut, oil 0.020000 1.000 1.000

14002690 14 Pecan 0.050000 1.000 1.000

14002820 14 Pistachio 0.050000 1.000 1.000

25002900 M Pork, meat 0.050000 1.000 1.000
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Page 22 of 40

25002901 M Pork, meat-babyfood 0.050000 1.000 1.000

25002910 M Pork, skin 0.050000 1.000 1.000

25002920 M Pork, meat byproducts 0.700000 1.000 1.000

25002921 M Pork, meat byproducts-babyfood 0.700000 1.000 1.000

25002930 M Pork, fat 0.050000 1.430 1.000

25002931 M Pork, fat-babyfood 0.050000 1.430 1.000

25002940 M Pork, kidney 0.700000 1.000 1.000

25002950 M Pork, liver 0.700000 1.000 1.000

01032960 1C Potato, chips 0.020000 1.000 1.000

01032970 1C Potato, dry (granules/ flakes) 0.020000 1.000 1.000

01032971 1C Potato, dry (granules/ flakes)-b 0.020000 1.000 1.000

01032980 1C Potato, flour 0.020000 1.000 1.000

01032981 1C Potato, flour-babyfood 0.020000 1.000 1.000

01032990 1C Potato, tuber, w/peel 0.020000 1.000 1.000

01032991 1C Potato, tuber, w/peel-babyfood 0.020000 1.000 1.000

01033000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000

01033001 1C Potato, tuber, w/o peel-babyfood 0.020000 1.000 1.000

60003010 P Poultry, other, meat 0.150000 1.000 1.000

60003020 P Poultry, other, liver 0.600000 1.000 1.000

60003030 P Poultry, other, meat byproducts 0.600000 1.000 1.000

60003040 P Poultry, other, fat 0.200000 1.390 1.000

60003050 P Poultry, other, skin 0.200000 1.390 1.000

29003120 M Rabbit, meat 0.150000 1.000 1.000

20003190 20 Rapeseed, oil 1.800000 1.500 1.000

20003191 20 Rapeseed, oil-babyfood 1.800000 1.500 1.000

15003280 15 Rye, grain 1.500000 1.000 1.000

15003290 15 Rye, flour 1.500000 1.000 1.000

26003390 M Sheep, meat 0.150000 1.000 1.000

26003391 M Sheep, meat-babyfood 0.150000 1.000 1.000

26003400 M Sheep, meat byproducts 1.100000 1.000 1.000

26003410 M Sheep, fat 0.110000 1.430 1.000

26003411 M Sheep, fat-babyfood 0.110000 1.430 1.000

26003420 M Sheep, kidney 1.100000 1.000 1.000

26003430 M Sheep, liver 1.100000 1.000 1.000

15003440 15 Sorghum, grain 1.500000 1.000 1.000

15003450 15 Sorghum, syrup 1.500000 1.000 1.000

06003470 6 Soybean, seed 0.100000 1.000 1.000

06003480 6 Soybean, flour 0.100000 1.000 1.000

06003481 6 Soybean, flour-babyfood 0.100000 1.000 1.000

06003490 6 Soybean, soy milk 0.100000 1.000 1.000

06003491 6 Soybean, soy milk-babyfood or in 0.100000 1.000 1.000

06003500 6 Soybean, oil 0.100000 1.000 1.000

06003501 6 Soybean, oil-babyfood 0.100000 1.000 1.000

95003590 O Strawberry 1.500000 1.000 1.000

95003591 O Strawberry-babyfood 1.500000 1.000 1.000

95003600 O Strawberry, juice 1.500000 1.000 1.000

95003601 O Strawberry, juice-babyfood 1.500000 1.000 1.000

15003810 15 Triticale, flour 1.500000 1.000 1.000

15003811 15 Triticale, flour-babyfood 1.500000 1.000 1.000

50003820 P Turkey, meat 0.150000 1.000 1.000

50003821 P Turkey, meat-babyfood 0.150000 1.000 1.000

50003830 P Turkey, liver 0.600000 1.000 1.000

50003831 P Turkey, liver-babyfood 0.600000 1.000 1.000

50003840 P Turkey, meat byproducts 0.600000 1.000 1.000

50003841 P Turkey, meat byproducts-babyfood 0.600000 1.000 1.000

50003850 P Turkey, fat 0.200000 1.390 1.000

50003851 P Turkey, fat-babyfood 0.200000 1.390 1.000

50003860 P Turkey, skin 0.200000 1.390 1.000

50003861 P Turkey, skin-babyfood 0.200000 1.390 1.000

14003910 14 Walnut 0.050000 1.000 1.000

86010000 O Water, direct, all sources 0.013000 1.000 1.000

86020000 O Water, indirect, all sources 0.013000 1.000 1.000

09013990 9A Watermelon 1.000000 1.000 1.000

09014000 9A Watermelon, juice 1.000000 1.000 1.000

15004010 15 Wheat, grain 1.500000 1.000 1.000

15004011 15 Wheat, grain-babyfood 1.500000 1.000 1.000

15004020 15 Wheat, flour 1.500000 1.000 1.000

15004021 15 Wheat, flour-babyfood 1.500000 1.000 1.000

15004030 15 Wheat, germ 1.500000 2.400 1.000
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

Page 23 of 40

15004040 15 Wheat, bran 1.500000 2.700 1.000

Attachment 4. Acute Dietary Analysis Results File - Food & Drinking Water

U.S. Environmental Protection Agency Ver. 2.02

DEEM-FCID ACUTE Analysis for FLUOPYRAM (1994-98 data)

Residue file: Tolerance 2011-08-08.R98 Adjustment factor #2 NOT used.

Analysis Date: 09-23-2011/15:04:41 Residue file dated: 09-23-2011/14:56:51/8

Daily totals for food and foodform consumption used.

Run Comment: "Tolerance residues 2011-08-08 crops 13 ppb water"

===============================================================================

Summary calculations (per capita):

 95th Percentile 99th Percentile 99.9th Percentile

 Exposure % aRfD Exposure % aRfD Exposure % aRfD 

 ---------- -------- ---------- -------- ---------- --------

U.S. Population:

 0.020741 4.15 0.033456 6.69 0.054800 10.96 

All infants:

 0.038195 7.64 0.063671 12.73 0.112337 22.47 

Children 1-2 yrs:

 0.042156 8.43 0.054792 10.96 0.078116 15.62 

Children 3-5 yrs:

 0.035136 7.03 0.047878 9.58 0.073838 14.77 

Children 6-12 yrs:

 0.024081 4.82 0.035065 7.01 0.054834 10.97 

Youth 13-19 yrs:

 0.015398 3.08 0.024207 4.84 0.037645 7.53 

Adults 20-49 yrs:

 0.013032 2.61 0.019434 3.89 0.032439 6.49 

Adults 50+ yrs:

 0.011141 2.23 0.017676 3.54 0.031026 6.21 

Females 13-49 yrs:

 0.012844 2.57 0.019692 3.94 0.032515 6.50 

Attachment 5. Chronic Dietary Analysis Input File - Food + Drinking Water 

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for FLUOPYRAM 1994-98 data

Residue file: C:\Documents and Settings\lcheng\My Documents\DEEM FCID 

lc\Fluopyram\chronic AR 2011-08-08 water.R98

 Adjust. #2 NOT used

Analysis Date 09-23-2011 Residue file dated: 09-23-2011/14:39:42/8

Reference dose (RfD) = 0.012 mg/kg bw/day

Comment:chronic assess 2011-08-08 crops 5 ppb water

--------------------------------------------------------------------------------

Food Crop Residue Adj.Factors Comment

EPA Code Grp Food Name (ppm) 

 #1 #2 

-------- ---- ------------------------------- ---------- ------ ------ -------

14000030 14 Almond 0.010000 1.000 0.330 

14000031 14 Almond-babyfood 0.010000 1.000 0.330 

14000040 14 Almond, oil 0.010000 1.000 0.330 

14000041 14 Almond, oil-babyfood 0.010000 1.000 0.330 

11000070 11 Apple, fruit with peel 0.110000 0.700 0.400 

11000080 11 Apple, peeled fruit 0.110000 0.030 0.400 

11000081 11 Apple, peeled fruit-babyfood 0.110000 0.030 0.400 

11000090 11 Apple, dried 0.110000 0.030 0.400 

11000091 11 Apple, dried-babyfood 0.110000 0.030 0.400 

11000100 11 Apple, juice 0.110000 0.400 0.400 

11000101 11 Apple, juice-babyfood 0.110000 0.400 0.400 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

Page 24 of 40

11000110 11 Apple, sauce 0.110000 0.010 0.400 

11000111 11 Apple, sauce-babyfood 0.110000 0.010 0.400 

95000230 O Banana 0.020000 1.000 1.000 

95000231 O Banana-babyfood 0.020000 1.000 1.000 

95000240 O Banana, dried 0.020000 3.900 1.000 

95000241 O Banana, dried-babyfood 0.020000 3.900 1.000 

15000250 15 Barley, pearled barley 0.220000 1.000 0.220 

15000251 15 Barley, pearled barley-babyfood 0.220000 1.000 0.220 

15000260 15 Barley, flour 0.220000 0.120 0.220 

15000261 15 Barley, flour-babyfood 0.220000 0.120 0.220 

15000270 15 Barley, bran 0.220000 2.700 0.220 

06030300 6C Bean, black, seed 0.010000 6.100 0.070 

06030320 6C Bean, broad, seed 0.010000 6.100 0.070 

06030340 6C Bean, cowpea, seed 0.010000 6.100 0.070 

06030350 6C Bean, great northern, seed 0.010000 6.100 0.070 

06030360 6C Bean, kidney, seed 0.010000 6.100 0.070 

06030380 6C Bean, lima, seed 0.010000 6.100 0.070 

06030390 6C Bean, mung, seed 0.010000 6.100 0.070 

06030400 6C Bean, navy, seed 0.010000 6.100 0.070 

06030410 6C Bean, pink, seed 0.010000 6.100 0.070 

06030420 6C Bean, pinto, seed 0.010000 6.100 0.070 

21000440 M Beef, meat 0.000700 1.000 1.000 

21000441 M Beef, meat-babyfood 0.000700 1.000 1.000 

21000450 M Beef, meat, dried 0.000700 1.920 1.000 

21000460 M Beef, meat byproducts 0.001100 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.001100 1.000 1.000 

21000470 M Beef, fat 0.000400 1.000 1.000 

21000471 M Beef,fat-babyfood 0.000400 1.000 1.000 

21000480 M Beef, kidney 0.001100 1.000 1.000 

21000490 M Beef, liver 0.006900 1.000 1.000 

21000491 M Beef, liver-babyfood 0.006900 1.000 1.000 

01010520 1A Beet, sugar 0.010000 1.300 0.480 

01010521 1A Beet, sugar-babyfood 0.010000 1.300 0.480 

01010530 1A Beet, sugar, molasses 0.010000 0.900 0.480 

01010531 1A Beet, sugar, molasses-babyfood 0.010000 0.900 0.480 

14000590 14 Brazil nut 0.010000 1.000 1.000 

15000650 15 Buckwheat 0.220000 1.000 1.000 

15000660 15 Buckwheat, flour 0.220000 0.120 1.000 

14000680 14 Butternut 0.010000 1.000 1.000 

14000810 14 Cashew 0.010000 1.000 1.000 

12000900 12 Cherry 0.190000 1.000 0.490 

12000901 12 Cherry-babyfood 0.190000 1.000 0.490 

12000910 12 Cherry, juice 0.190000 1.000 0.490 

12000911 12 Cherry, juice-babyfood 0.190000 1.000 0.490 

14000920 14 Chestnut 0.010000 1.000 1.000 

40000930 P Chicken, meat 0.014000 1.000 1.000 

40000931 P Chicken, meat-babyfood 0.014000 1.000 1.000 

40000940 P Chicken, liver 0.022000 1.000 1.000 

40000950 P Chicken, meat byproducts 0.014000 1.000 1.000 

40000951 P Chicken, meat byproducts-babyfoo 0.014000 1.000 1.000 

40000960 P Chicken, fat 0.014000 1.000 1.000 

40000961 P Chicken, fat-babyfood 0.014000 1.000 1.000 

40000970 P Chicken, skin 0.014000 1.000 1.000 

40000971 P Chicken, skin-babyfood 0.014000 1.000 1.000 

06030980 6C Chickpea, seed 0.010000 6.100 0.070 

06030981 6C Chickpea, seed-babyfood 0.010000 6.100 0.070 

06030990 6C Chickpea, flour 0.010000 6.100 0.070 

15001200 15 Corn, field, flour 0.010000 0.850 0.010 

15001201 15 Corn, field, flour-babyfood 0.010000 0.850 0.010 

15001210 15 Corn, field, meal 0.010000 0.800 0.010 

15001211 15 Corn, field, meal-babyfood 0.010000 0.800 0.010 

15001220 15 Corn, field, bran 0.010000 2.640 0.010 

15001230 15 Corn, field, starch 0.010000 0.150 0.010 

15001231 15 Corn, field, starch-babyfood 0.010000 0.150 0.010 

15001240 15 Corn, field, syrup 0.010000 1.000 0.010 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

Page 25 of 40

15001241 15 Corn, field, syrup-babyfood 0.010000 1.000 0.010 

15001250 15 Corn, field, oil 0.010000 0.350 0.010 

15001251 15 Corn, field, oil-babyfood 0.010000 0.350 0.010 

15001260 15 Corn, pop 0.010000 1.000 0.010 

15001270 15 Corn, sweet 0.005000 1.000 0.010 

15001271 15 Corn, sweet-babyfood 0.005000 1.000 0.010 

95001280 O Cottonseed, oil 0.010000 0.015 0.070 

95001281 O Cottonseed, oil-babyfood 0.010000 0.015 0.070 

70001450 P Egg, whole 0.014000 1.000 1.000 

70001451 P Egg, whole-babyfood 0.014000 1.000 1.000 

70001460 P Egg, white 0.014000 1.000 1.000 

70001461 P Egg, white (solids)-babyfood 0.014000 1.000 1.000 

70001470 P Egg, yolk 0.014000 1.000 1.000 

70001471 P Egg, yolk-babyfood 0.014000 1.000 1.000 

14001550 14 Filbert 0.010000 1.000 1.000 

14001560 14 Filbert, oil 0.010000 1.000 1.000 

23001690 M Goat, meat 0.000700 1.000 1.000 

23001700 M Goat, meat byproducts 0.001100 1.000 1.000 

23001710 M Goat, fat 0.000400 1.000 1.000 

23001720 M Goat, kidney 0.001100 1.000 1.000 

23001730 M Goat, liver 0.006900 1.000 1.000 

95001790 O Grape, wine and sherry 0.400000 0.500 0.790 

06031820 6C Guar, seed 0.010000 6.100 0.070 

06031821 6C Guar, seed-babyfood 0.010000 6.100 0.070 

14001850 14 Hickory nut 0.010000 1.000 1.000 

24001890 M Horse, meat 0.000700 1.000 1.000 

06032030 6C Lentil, seed 0.010000 6.100 0.070 

14002130 14 Macadamia nut 0.010000 1.000 1.000 

28002210 M Meat, game 0.000700 1.000 1.000 

27002220 D Milk, fat 0.002900 1.000 1.000 

27002221 D Milk, fat - baby food/infant for 0.002900 1.000 1.000 

27012230 D Milk, nonfat solids 0.002900 1.000 1.000 

27012231 D Milk, nonfat solids-baby food/in 0.002900 1.000 1.000 

27022240 D Milk, water 0.002900 1.000 1.000 

27022241 D Milk, water-babyfood/infant form 0.002900 1.000 1.000 

27032251 D Milk, sugar (lactose)-baby food/ 0.002900 1.000 1.000 

15002260 15 Millet, grain 0.620000 1.000 1.000 

15002310 15 Oat, bran 0.220000 1.000 0.230 

15002320 15 Oat, flour 0.220000 1.000 0.230 

15002321 15 Oat, flour-babyfood 0.220000 1.000 0.230 

15002330 15 Oat, groats/rolled oats 0.220000 1.000 0.230 

15002331 15 Oat, groats/rolled oats-babyfood 0.220000 1.000 0.230 

95002630 O Peanut 0.011000 1.000 0.670 

95002640 O Peanut, butter 0.011000 0.220 0.670 

95002650 O Peanut, oil 0.011000 0.260 0.670 

14002690 14 Pecan 0.010000 1.000 1.000 

14002820 14 Pistachio 0.010000 1.000 1.000 

25002900 M Pork, meat 0.001000 1.000 1.000 

25002901 M Pork, meat-babyfood 0.001000 1.000 1.000 

25002910 M Pork, skin 0.000500 1.000 1.000 

25002920 M Pork, meat byproducts 0.001500 1.000 1.000 

25002921 M Pork, meat byproducts-babyfood 0.001500 1.000 1.000 

25002930 M Pork, fat 0.000500 1.000 1.000 

25002931 M Pork, fat-babyfood 0.000500 1.000 1.000 

25002940 M Pork, kidney 0.001500 1.000 1.000 

25002950 M Pork, liver 0.009000 1.000 1.000 

01032960 1C Potato, chips 0.010000 0.300 0.640 

01032970 1C Potato, dry (granules/ flakes) 0.010000 1.000 0.640 

01032971 1C Potato, dry (granules/ flakes)-b 0.010000 1.000 0.640 

01032980 1C Potato, flour 0.010000 1.000 0.640 

01032981 1C Potato, flour-babyfood 0.010000 1.000 0.640 

01032990 1C Potato, tuber, w/peel 0.010000 1.000 0.640 

01032991 1C Potato, tuber, w/peel-babyfood 0.010000 1.000 0.640 

01033000 1C Potato, tuber, w/o peel 0.010000 0.200 0.640 

01033001 1C Potato, tuber, w/o peel-babyfood 0.010000 0.200 0.640 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

Page 26 of 40

60003010 P Poultry, other, meat 0.014000 1.000 1.000 

60003020 P Poultry, other, liver 0.022000 1.000 1.000 

60003030 P Poultry, other, meat byproducts 0.014000 1.000 1.000 

60003040 P Poultry, other, fat 0.014000 1.000 1.000 

60003050 P Poultry, other, skin 0.014000 1.000 1.000 

29003120 M Rabbit, meat 0.014000 1.000 1.000 

20003190 20 Rapeseed, oil 0.510000 0.015 0.730 

20003191 20 Rapeseed, oil-babyfood 0.510000 0.015 0.730 

15003280 15 Rye, grain 0.220000 1.000 0.630 

15003290 15 Rye, flour 0.220000 1.000 0.630 

26003390 M Sheep, meat 0.000700 1.000 1.000 

26003391 M Sheep, meat-babyfood 0.000700 1.000 1.000 

26003400 M Sheep, meat byproducts 0.001100 1.000 1.000 

26003410 M Sheep, fat 0.000400 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.000400 1.000 1.000 

26003420 M Sheep, kidney 0.001100 1.000 1.000 

26003430 M Sheep, liver 0.006900 1.000 1.000 

15003440 15 Sorghum, grain 0.620000 1.000 0.120 

15003450 15 Sorghum, syrup 0.620000 1.000 0.120 

06003470 6 Soybean, seed 0.024000 1.000 0.010 

06003480 6 Soybean, flour 0.024000 0.040 0.010 

06003481 6 Soybean, flour-babyfood 0.024000 0.040 0.010 

06003490 6 Soybean, soy milk 0.024000 0.010 0.010 

06003491 6 Soybean, soy milk-babyfood or in 0.024000 0.010 0.010 

06003500 6 Soybean, oil 0.024000 0.020 0.010 

06003501 6 Soybean, oil-babyfood 0.024000 0.020 0.010 

95003590 O Strawberry 0.190000 1.000 0.710 

95003591 O Strawberry-babyfood 0.190000 1.000 0.710 

95003600 O Strawberry, juice 0.190000 1.000 0.710 

95003601 O Strawberry, juice-babyfood 0.190000 1.000 0.710 

15003810 15 Triticale, flour 0.220000 1.000 1.000 

15003811 15 Triticale, flour-babyfood 0.220000 1.000 1.000 

50003820 P Turkey, meat 0.014000 1.000 1.000 

50003821 P Turkey, meat-babyfood 0.014000 1.000 1.000 

50003830 P Turkey, liver 0.022000 1.000 1.000 

50003831 P Turkey, liver-babyfood 0.022000 1.000 1.000 

50003840 P Turkey, meat byproducts 0.014000 1.000 1.000 

50003841 P Turkey, meat byproducts-babyfood 0.014000 1.000 1.000 

50003850 P Turkey, fat 0.014000 1.000 1.000 

50003851 P Turkey, fat-babyfood 0.014000 1.000 1.000 

50003860 P Turkey, skin 0.014000 1.000 1.000 

50003861 P Turkey, skin-babyfood 0.014000 1.000 1.000 

14003910 14 Walnut 0.010000 1.000 1.000 

86010000 O Water, direct, all sources 0.004900 1.000 1.000 

86020000 O Water, indirect, all sources 0.004900 1.000 1.000 

09013990 9A Watermelon 0.220000 1.000 0.540 

09014000 9A Watermelon, juice 0.220000 1.000 0.540 

15004010 15 Wheat, grain 0.220000 1.000 0.010 

15004011 15 Wheat, grain-babyfood 0.220000 1.000 0.010 

15004020 15 Wheat, flour 0.220000 0.120 0.010 

15004021 15 Wheat, flour-babyfood 0.220000 0.120 0.010 

15004030 15 Wheat, germ 0.220000 2.400 0.010 

15004040 15 Wheat, bran 0.220000 2.700 0.010 

Attachment 6. Chronic Dietary Analysis Results File - Food + Drinking Water 

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for FLUOPYRAM (1994-98 data)

Residue file name: C:\Documents and Settings\lcheng\My Documents\DEEM FCID 

lc\Fluopyram\chronic AR 2011-08-08 water.R98

 Adjustment factor #2 NOT used.

Analysis Date 09-23-2011/15:27:51 Residue file dated: 09-23-2011/14:39:42/8

Reference dose (RfD, Chronic) = .012 mg/kg bw/day

COMMENT 1: chronic assess 2011-08-08 crops 5 ppb water
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

Page 27 of 40

===============================================================================

 Total exposure by population subgroup

-------------------------------------------------------------------------------

 Total Exposure

 -----------------------------------

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

-------------------------------------- ------------- ---------------

U.S. Population (total) 0.000423 3.5%

U.S. Population (spring season) 0.000443 3.7%

U.S. Population (summer season) 0.000453 3.8%

U.S. Population (autumn season) 0.000400 3.3%

U.S. Population (winter season) 0.000395 3.3%

Northeast region 0.000436 3.6%

Midwest region 0.000421 3.5%

Southern region 0.000373 3.1%

Western region 0.000491 4.1%

Hispanics 0.000454 3.8%

Non-hispanic whites 0.000423 3.5%

Non-hispanic blacks 0.000367 3.1%

Non-hisp/non-white/non-black 0.000509 4.2%

All infants (< 1 year) 0.000800 6.7%

Nursing infants 0.000375 3.1%

Non-nursing infants 0.000961 8.0%

Children 1-6 yrs 0.001053 8.8%

Children 7-12 yrs 0.000536 4.5%

Females 13-19 (not preg or nursing) 0.000288 2.4%

Females 20+ (not preg or nursing) 0.000341 2.8%

Females 13-50 yrs 0.000350 2.9%

Females 13+ (preg/not nursing) 0.000375 3.1%

Females 13+ (nursing) 0.000531 4.4%

Males 13-19 yrs 0.000340 2.8%

Males 20+ yrs 0.000319 2.7%

Seniors 55+ 0.000359 3.0%

Children 1-2 yrs 0.001239 10.3%

Children 3-5 yrs 0.001017 8.5%

Children 6-12 yrs 0.000574 4.8%

Youth 13-19 yrs 0.000315 2.6%

Adults 20-49 yrs 0.000320 2.7%

Adults 50+ yrs 0.000353 2.9%

Females 13-49 yrs 0.000326 2.7%

Attachment 7. Cancer Dietary Analysis Input File - Food + Drinking Water 

Filename: C:\Documents and Settings\lcheng\My Documents\DEEM FCID lc\Fluopyram\cancer 

assess 2011-08-03 water.R98

Chemical: Fluopyram

RfD(Chronic): .012 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Q*= .0155

Date created/last modified: 08-03-2011/10:18:54/8 Program ver. 2.03

Comment: cancer assess 2011-08-03 water 3.5 ppb

--------------------------------------------------------------------------------

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

-------- ---- ------------------------------- ---------- ------ ------ -------

14000030 14 Almond 0.010000 1.000 0.330 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

Page 28 of 40

14000031 14 Almond-babyfood 0.010000 1.000 0.330 

14000040 14 Almond, oil 0.010000 1.000 0.330 

14000041 14 Almond, oil-babyfood 0.010000 1.000 0.330 

11000070 11 Apple, fruit with peel 0.110000 0.700 0.400 

11000080 11 Apple, peeled fruit 0.110000 0.030 0.400 

11000081 11 Apple, peeled fruit-babyfood 0.110000 0.030 0.400 

11000090 11 Apple, dried 0.110000 0.030 0.400 

11000091 11 Apple, dried-babyfood 0.110000 0.030 0.400 

11000100 11 Apple, juice 0.110000 0.400 0.400 

11000101 11 Apple, juice-babyfood 0.110000 0.400 0.400 

11000110 11 Apple, sauce 0.110000 0.010 0.400 

11000111 11 Apple, sauce-babyfood 0.110000 0.010 0.400 

95000230 O Banana 0.020000 1.000 1.000 

95000231 O Banana-babyfood 0.020000 1.000 1.000 

95000240 O Banana, dried 0.020000 3.900 1.000 

95000241 O Banana, dried-babyfood 0.020000 3.900 1.000 

15000250 15 Barley, pearled barley 0.220000 1.000 0.220 

15000251 15 Barley, pearled barley-babyfood 0.220000 1.000 0.220 

15000260 15 Barley, flour 0.220000 0.120 0.220 

15000261 15 Barley, flour-babyfood 0.220000 0.120 0.220 

15000270 15 Barley, bran 0.220000 2.700 0.220 

06030300 6C Bean, black, seed 0.010000 6.100 0.070 

06030320 6C Bean, broad, seed 0.010000 6.100 0.070 

06030340 6C Bean, cowpea, seed 0.010000 6.100 0.070 

06030350 6C Bean, great northern, seed 0.010000 6.100 0.070 

06030360 6C Bean, kidney, seed 0.010000 6.100 0.070 

06030380 6C Bean, lima, seed 0.010000 6.100 0.070 

06030390 6C Bean, mung, seed 0.010000 6.100 0.070 

06030400 6C Bean, navy, seed 0.010000 6.100 0.070 

06030410 6C Bean, pink, seed 0.010000 6.100 0.070 

06030420 6C Bean, pinto, seed 0.010000 6.100 0.070 

21000440 M Beef, meat 0.000700 1.000 1.000 

21000441 M Beef, meat-babyfood 0.000700 1.000 1.000 

21000450 M Beef, meat, dried 0.000700 1.920 1.000 

21000460 M Beef, meat byproducts 0.001100 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.001100 1.000 1.000 

21000470 M Beef, fat 0.000400 1.000 1.000 

21000471 M Beef,fat-babyfood 0.000400 1.000 1.000 

21000480 M Beef, kidney 0.001100 1.000 1.000 

21000490 M Beef, liver 0.006900 1.000 1.000 

21000491 M Beef, liver-babyfood 0.006900 1.000 1.000 

01010520 1A Beet, sugar 0.010000 1.300 0.480 

01010521 1A Beet, sugar-babyfood 0.010000 1.300 0.480 

01010530 1A Beet, sugar, molasses 0.010000 0.900 0.480 

01010531 1A Beet, sugar, molasses-babyfood 0.010000 0.900 0.480 

14000590 14 Brazil nut 0.010000 1.000 1.000 

15000650 15 Buckwheat 0.220000 1.000 1.000 

15000660 15 Buckwheat, flour 0.220000 0.120 1.000 

14000680 14 Butternut 0.010000 1.000 1.000 

14000810 14 Cashew 0.010000 1.000 1.000 

12000900 12 Cherry 0.190000 1.000 0.490 

12000901 12 Cherry-babyfood 0.190000 1.000 0.490 

12000910 12 Cherry, juice 0.190000 1.000 0.490 

12000911 12 Cherry, juice-babyfood 0.190000 1.000 0.490 

14000920 14 Chestnut 0.010000 1.000 1.000 

40000930 P Chicken, meat 0.014000 1.000 1.000 

40000931 P Chicken, meat-babyfood 0.014000 1.000 1.000 

40000940 P Chicken, liver 0.022000 1.000 1.000 

40000950 P Chicken, meat byproducts 0.014000 1.000 1.000 

40000951 P Chicken, meat byproducts-babyfoo 0.014000 1.000 1.000 

40000960 P Chicken, fat 0.014000 1.000 1.000 

40000961 P Chicken, fat-babyfood 0.014000 1.000 1.000 

40000970 P Chicken, skin 0.014000 1.000 1.000 

40000971 P Chicken, skin-babyfood 0.014000 1.000 1.000 

06030980 6C Chickpea, seed 0.010000 6.100 0.070 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

______________________________________________________________________________________

Page 29 of 40

06030981 6C Chickpea, seed-babyfood 0.010000 6.100 0.070 

06030990 6C Chickpea, flour 0.010000 6.100 0.070 

15001200 15 Corn, field, flour 0.010000 0.850 0.010 

15001201 15 Corn, field, flour-babyfood 0.010000 0.850 0.010 

15001210 15 Corn, field, meal 0.010000 0.800 0.010 

15001211 15 Corn, field, meal-babyfood 0.010000 0.800 0.010 

15001220 15 Corn, field, bran 0.010000 2.640 0.010 

15001230 15 Corn, field, starch 0.010000 0.150 0.010 

15001231 15 Corn, field, starch-babyfood 0.010000 0.150 0.010 

15001240 15 Corn, field, syrup 0.010000 1.000 0.010 

15001241 15 Corn, field, syrup-babyfood 0.010000 1.000 0.010 

15001250 15 Corn, field, oil 0.010000 0.350 0.010 

15001251 15 Corn, field, oil-babyfood 0.010000 0.350 0.010 

15001260 15 Corn, pop 0.010000 1.000 0.010 

15001270 15 Corn, sweet 0.005000 1.000 0.010 

15001271 15 Corn, sweet-babyfood 0.005000 1.000 0.010 

95001280 O Cottonseed, oil 0.010000 0.015 0.070 

95001281 O Cottonseed, oil-babyfood 0.010000 0.015 0.070 

70001450 P Egg, whole 0.014000 1.000 1.000 

70001451 P Egg, whole-babyfood 0.014000 1.000 1.000 

70001460 P Egg, white 0.014000 1.000 1.000 

70001461 P Egg, white (solids)-babyfood 0.014000 1.000 1.000 

70001470 P Egg, yolk 0.014000 1.000 1.000 

70001471 P Egg, yolk-babyfood 0.014000 1.000 1.000 

14001550 14 Filbert 0.010000 1.000 1.000 

14001560 14 Filbert, oil 0.010000 1.000 1.000 

23001690 M Goat, meat 0.000700 1.000 1.000 

23001700 M Goat, meat byproducts 0.001100 1.000 1.000 

23001710 M Goat, fat 0.000400 1.000 1.000 

23001720 M Goat, kidney 0.001100 1.000 1.000 

23001730 M Goat, liver 0.006900 1.000 1.000 

95001790 O Grape, wine and sherry 0.400000 0.500 0.790 

06031820 6C Guar, seed 0.010000 6.100 0.070 

06031821 6C Guar, seed-babyfood 0.010000 6.100 0.070 

14001850 14 Hickory nut 0.010000 1.000 1.000 

24001890 M Horse, meat 0.000700 1.000 1.000 

06032030 6C Lentil, seed 0.010000 6.100 0.070 

14002130 14 Macadamia nut 0.010000 1.000 1.000 

28002210 M Meat, game 0.000700 1.000 1.000 

27002220 D Milk, fat 0.002900 1.000 1.000 

27002221 D Milk, fat - baby food/infant for 0.002900 1.000 1.000 

27012230 D Milk, nonfat solids 0.002900 1.000 1.000 

27012231 D Milk, nonfat solids-baby food/in 0.002900 1.000 1.000 

27022240 D Milk, water 0.002900 1.000 1.000 

27022241 D Milk, water-babyfood/infant form 0.002900 1.000 1.000 

27032251 D Milk, sugar (lactose)-baby food/ 0.002900 1.000 1.000 

15002260 15 Millet, grain 0.620000 1.000 1.000 

15002310 15 Oat, bran 0.220000 1.000 0.230 

15002320 15 Oat, flour 0.220000 1.000 0.230 

15002321 15 Oat, flour-babyfood 0.220000 1.000 0.230 

15002330 15 Oat, groats/rolled oats 0.220000 1.000 0.230 

15002331 15 Oat, groats/rolled oats-babyfood 0.220000 1.000 0.230 

95002630 O Peanut 0.011000 1.000 0.670 

95002640 O Peanut, butter 0.011000 0.220 0.670 

95002650 O Peanut, oil 0.011000 0.260 0.670 

14002690 14 Pecan 0.010000 1.000 1.000 

14002820 14 Pistachio 0.010000 1.000 1.000 

25002900 M Pork, meat 0.001000 1.000 1.000 

25002901 M Pork, meat-babyfood 0.001000 1.000 1.000 

25002910 M Pork, skin 0.000500 1.000 1.000 

25002920 M Pork, meat byproducts 0.001500 1.000 1.000 

25002921 M Pork, meat byproducts-babyfood 0.001500 1.000 1.000 

25002930 M Pork, fat 0.000500 1.000 1.000 

25002931 M Pork, fat-babyfood 0.000500 1.000 1.000 

25002940 M Pork, kidney 0.001500 1.000 1.000 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Page 30 of 40

25002950 M Pork, liver 0.009000 1.000 1.000 

01032960 1C Potato, chips 0.010000 0.300 0.640 

01032970 1C Potato, dry (granules/ flakes) 0.010000 1.000 0.640 

01032971 1C Potato, dry (granules/ flakes)-b 0.010000 1.000 0.640 

01032980 1C Potato, flour 0.010000 1.000 0.640 

01032981 1C Potato, flour-babyfood 0.010000 1.000 0.640 

01032990 1C Potato, tuber, w/peel 0.010000 1.000 0.640 

01032991 1C Potato, tuber, w/peel-babyfood 0.010000 1.000 0.640 

01033000 1C Potato, tuber, w/o peel 0.010000 0.200 0.640 

01033001 1C Potato, tuber, w/o peel-babyfood 0.010000 0.200 0.640 

60003010 P Poultry, other, meat 0.014000 1.000 1.000 

60003020 P Poultry, other, liver 0.022000 1.000 1.000 

60003030 P Poultry, other, meat byproducts 0.014000 1.000 1.000 

60003040 P Poultry, other, fat 0.014000 1.000 1.000 

60003050 P Poultry, other, skin 0.014000 1.000 1.000 

29003120 M Rabbit, meat 0.014000 1.000 1.000 

20003190 20 Rapeseed, oil 0.510000 0.015 0.730 

20003191 20 Rapeseed, oil-babyfood 0.510000 0.015 0.730 

15003280 15 Rye, grain 0.220000 1.000 0.630 

15003290 15 Rye, flour 0.220000 1.000 0.630 

26003390 M Sheep, meat 0.000700 1.000 1.000 

26003391 M Sheep, meat-babyfood 0.000700 1.000 1.000 

26003400 M Sheep, meat byproducts 0.001100 1.000 1.000 

26003410 M Sheep, fat 0.000400 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.000400 1.000 1.000 

26003420 M Sheep, kidney 0.001100 1.000 1.000 

26003430 M Sheep, liver 0.006900 1.000 1.000 

15003440 15 Sorghum, grain 0.620000 1.000 0.120 

15003450 15 Sorghum, syrup 0.620000 1.000 0.120 

06003470 6 Soybean, seed 0.024000 1.000 0.010 

06003480 6 Soybean, flour 0.024000 0.040 0.010 

06003481 6 Soybean, flour-babyfood 0.024000 0.040 0.010 

06003490 6 Soybean, soy milk 0.024000 0.010 0.010 

06003491 6 Soybean, soy milk-babyfood or in 0.024000 0.010 0.010 

06003500 6 Soybean, oil 0.024000 0.020 0.010 

06003501 6 Soybean, oil-babyfood 0.024000 0.020 0.010 

95003590 O Strawberry 0.190000 1.000 0.710 

95003591 O Strawberry-babyfood 0.190000 1.000 0.710 

95003600 O Strawberry, juice 0.190000 1.000 0.710 

95003601 O Strawberry, juice-babyfood 0.190000 1.000 0.710 

15003810 15 Triticale, flour 0.220000 1.000 1.000 

15003811 15 Triticale, flour-babyfood 0.220000 1.000 1.000 

50003820 P Turkey, meat 0.014000 1.000 1.000 

50003821 P Turkey, meat-babyfood 0.014000 1.000 1.000 

50003830 P Turkey, liver 0.022000 1.000 1.000 

50003831 P Turkey, liver-babyfood 0.022000 1.000 1.000 

50003840 P Turkey, meat byproducts 0.014000 1.000 1.000 

50003841 P Turkey, meat byproducts-babyfood 0.014000 1.000 1.000 

50003850 P Turkey, fat 0.014000 1.000 1.000 

50003851 P Turkey, fat-babyfood 0.014000 1.000 1.000 

50003860 P Turkey, skin 0.014000 1.000 1.000 

50003861 P Turkey, skin-babyfood 0.014000 1.000 1.000 

14003910 14 Walnut 0.010000 1.000 1.000 

86010000 O Water, direct, all sources 0.003490 1.000 1.000 

86020000 O Water, indirect, all sources 0.003490 1.000 1.000 

09013990 9A Watermelon 0.220000 0.044 0.540 

09014000 9A Watermelon, juice 0.220000 0.044 0.540 

15004010 15 Wheat, grain 0.220000 1.000 0.010 

15004011 15 Wheat, grain-babyfood 0.220000 1.000 0.010 

15004020 15 Wheat, flour 0.220000 0.120 0.010 

15004021 15 Wheat, flour-babyfood 0.220000 0.120 0.010 

15004030 15 Wheat, germ 0.220000 2.400 0.010 

15004040 15 Wheat, bran 0.220000 2.700 0.010 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Attachment 8. Cancer Dietary Analysis Results File - Food + Drinking Water 

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for FLUOPYRAM (1994-98 data)

Residue file name: C:\Documents and Settings\lcheng\My Documents\DEEM FCID 

lc\Fluopyram\cancer assess 2011-08-03 water.R98

 Adjustment factor #2 used.

Analysis Date 08-03-2011/10:37:29 Residue file dated: 08-03-2011/10:18:54/8

Q* = 0.0155 

COMMENT 1: cancer assess 2011-08-03 water 3.5 ppb

===============================================================================

 Total exposure by population subgroup

-------------------------------------------------------------------------------

 Total Exposure

 -----------------------------------

 Population mg/kg Lifetime risk

 Subgroup body wt/day (Q*= .0155)

-------------------------------------- ------------- -------------

U.S. Population (total) 0.000188 2.92E-06

U.S. Population (spring season) 0.000193 2.99E-06

U.S. Population (summer season) 0.000188 2.92E-06

U.S. Population (autumn season) 0.000187 2.90E-06

U.S. Population (winter season) 0.000185 2.86E-06

Northeast region 0.000194 3.00E-06

Midwest region 0.000186 2.88E-06

Southern region 0.000167 2.59E-06

Western region 0.000220 3.41E-06

Hispanics 0.000203 3.15E-06

Non-hispanic whites 0.000190 2.94E-06

Non-hispanic blacks 0.000160 2.48E-06

Non-hisp/non-white/non-black 0.000205 3.18E-06

All infants (< 1 year) 0.000434 6.72E-06

Nursing infants 0.000186 2.88E-06

Non-nursing infants 0.000528 8.18E-06

Children 1-6 yrs 0.000439 6.80E-06

Children 7-12 yrs 0.000209 3.24E-06

Females 13-19 (not preg or nursing) 0.000118 1.83E-06

Females 20+ (not preg or nursing) 0.000164 2.54E-06

Females 13-50 yrs 0.000162 2.51E-06

Females 13+ (preg/not nursing) 0.000163 2.53E-06

Females 13+ (nursing) 0.000210 3.26E-06

Males 13-19 yrs 0.000130 2.02E-06

Males 20+ yrs 0.000147 2.28E-06

Seniors 55+ 0.000168 2.61E-06

Children 1-2 yrs 0.000543 8.42E-06

Children 3-5 yrs 0.000410 6.35E-06

Children 6-12 yrs 0.000225 3.49E-06

Youth 13-19 yrs 0.000124 1.93E-06

Adults 20-49 yrs 0.000151 2.33E-06

Adults 50+ yrs 0.000166 2.58E-06

Females 13-49 yrs 0.000153 2.36E-06
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Attachment 9. BEAD Projected Percent Crop Treated Memo (5/23/2011)

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

 

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

MEMORANDUM

SUBJECT: Percent Crop Treated for New Uses of Fluopyram on Cantaloupe, Cucumber, Dry Beans, Peanuts, 

Potatoes, Pumpkin, Squash, Sugar Beet, and Watermelon. Analysis of the 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 of Dry Beans and 

Potatoes 

PC#080302, DP# 387227

FROM:Jihad Alsadek, Ph.D., Economist

Science Information and Analysis Branch

Carl Chen, Ph.D., Plant Pathologist

Biological Analysis Branch 

Biological and Economic Analysis Division (7503P)

THRU: Diann Sims, Chief

Science Information and Analysis Branch

Arnet Jones, Chief

Biological Analysis Branch

Biological and Economic Analysis Division (7503P)

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 of fluopyram 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 of the EPA’s PCTn (Bayer, 2011). BEAD PCTn values were compared 

with those submitted by the registrant as shown in Table 2. 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Page 33 of 40

Additionally, HED requested that BEAD analyze the approach BCS used to estimate PCT for rotated crops 

(wheat, corn, 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 estimate of the percent crop treated for the new use (PCTn) of fluopyram represent the upper bound of 

use expected during the pesticide’s initial five years of registration; 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) of the 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 of the 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

USDA/NASS 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 if the 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 of these 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 of the 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.

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 of the comparison of the 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% of the 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 if proprietary 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 of the market leader PCT values and 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 (Alsadek 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. 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Crop Market Leader (ML) Chemical Avg ML PCTn Max ML PCTn

CantaloupebSulfur

Triflumizole

22 31

Cucumberb Chlorothalonil 41 52

Dry Beans

a Thiophanate-Methyl

Pyraclostrobin

7 14

Peanuts

b Chlorothalonil

Mancozeb 

67 70

Potatoesb Mancozeb

Chlorothalonil

64 64

Pumpkinb Chlorothalonil 45 57

Squashb Chlorothalonil 47 54

Sugar Beets

a Tetraconazole

Pyraclostrobin

48 53

Watermelonb Chlorothalonil 54 58

 a Proprietary data (2006-2010)

 b NASS data (2002-2006)

IV. Evaluation of BCS PPCT Estimates and Analysis of Rotational Crop PCT Methodology Submitted 

by BCS

To evaluate the BCS PPCT estimates BEAD reviewed the most recent NASS data where available for all crops, 

except for cases where 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 of the 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 (2006-2010 due to the unavailability of NASS 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

PCTn

BCS PPCTs Difference 

(%)

CantaloupebSulfur/Triflumizole 22 34 55

Cucumberb Chlorothalonil 41 47 15

Dry Beansa Thiophanate-Methyl/ 

Pyraclostrobin

7 10 43

Peanuts

b Chlorothalonil/Mancozeb 67 67 0 

Potatoesb Mancozeb/ Chlorothalonil 64 60 -6

Pumpkinb Chlorothalonil 45 50 11

Squashb Chlorothalonil 47 54 15

Sugar beets

a Tetraconazole/Pyraclostrobin 48 46 -4

Watermelonb Chlorothalonil 54 59 9

 a Proprietary data (2006-2010)

 b NASS data (2002-2006)

In order to evaluate the methodology BCS used to determine PPCTs for rotated crops (wheat, corn, 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). 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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The BCS methodology assumed that each rotational crop is planted back on both acreage of dry beans and potatoes 

(808,000 Acres). It was assumed that 100 percent of the maximum available acreage (808,000 acres) could be 

planted back with each of the possible rotational crops, where plant back statements on the product labels reflect the 

ability to rotate to cereals, corn, 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 of these 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 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, corn, cereals, and soybeans. The plant back statements on the 

product labels have been modified to reflect these limitations on crop rotations.”

In the absence of sufficient 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. A conservative estimate of PPCT for 

the rotational crops in BCS methodology was determined as follows. The potential treated acres for each of the 

primary crops (dry beans and potatoes) which could be rotated to other crops were determined and added together. 

BCS assumed that 100 percent of that maximum available acreage (808,000 acres) could be planted back with each 

of the 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 

Items 2010 2009 2008 2007 2006

5 Year 

Avg.

BEAD 

PCTn

Treated. 

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)

Table 4. PCTn for Rotated Crops
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Data Items

Dry Beans and Potatoes

Acres Treated 5 Year Avg. PCTn Rotated Crops

Wheat 808,000 59,000,000 1

Corn 808,000 86,000,000 1

Sorghum 808,000 7,000,000 12

Barley 808,000 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: (1) the extent of pest pressure on the crops in question; (2) 

the pest spectrum of the 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 of registered 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) of minor 

economic concern. Finally, if the 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 (BEAN #387227), 

which are almonds, dry beans, peanuts, potatoes, sugar beets, and five cucurbits. A biological analysis of additional 

factors for the use of fluopyram 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 of the three main factors follows (Table 5). 

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

(CANTALOUPE, CUCUMBER, 

PUMPKIN, SQUASH, 

WATERMELON)

Alternaria leaf spot (Alternaria spp.); Gray mold (Botrytis 

cinerea); Gummy stem blight (Didymella bryoniae); Powdery 

mildew (Sphaeotheca fuliginea, Podosphaera xanthii, Erysiphe 

cichoracearum)

DRIED BEANS

Alternaria blight (Alternaria spp.); Alternaria leaf spot 

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

mildew (Erysiphe pisi); White mold (Sclerotinia sclerotiorum)

PEANUT Early leaf spot (Cercospora arachidicola); Late leaf spot 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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(Cercosporidium personatum)

POTATO

Botrytis leaf spot (Botrytis cinerea); Early blight (Alternaria 

solani); White mold (Sclerotinia sclerotiorum); Silver scurf 

(Helminthosporium solani)

SUGAR BEET Cercospora leaf spot (Cercospora beticola); Powdery mildew 

(Erysiphe polygoni)

 

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% of the 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 of them, 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 of two market leaders on cantaloupe, is a highrisk-for-resistance-development fungicide. FRAC ranks fluopyram as medium to high risk for resistance 

development and indicates that resistance management is required (FRAC, 2011).

Conclusion: Consideration of these 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 of the 

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 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-risk-for-resistancedevelopment fungicides. With different chemistries, both can be rotated or tank-mixed to reduce the risk of 

resistance 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 of these 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 of the 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.
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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 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 broad-spectrum 

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 of these 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 of the 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.

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 of them 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 of these 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 of the 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-for-resistance-development 

fungicides. With different chemistries, both can be rotated or tank-mixed to reduce the risk of resistance 

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 of these 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 of the 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

VI. CONCLUSIONS/RECOMMENDATIONS
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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 of Fluopyram 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 
Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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