Fluopyram Dietary Exposure and Risk Assessment DP Number: 389122

Page 1 of 40 **UNITED ST AT**  **ES ENVIRONMENT AL**  **PROTECTION A GENCY** 

**WA SHINGTON, D.C. 20460**  **OFFICE OF CHEMICAL SAFETY**  **AND POLLUTION PREVENTION**  **ME MORANDUM**  

### DATE: September 2 9 , 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 C rop Group 14, Watermelon , and Rotational Crops Alfalfa, Canola, Cotton, Cereal Grains (Except Rice) C rop Group 15, and Forage of Cereal Grains (Except Rice) C rop Group 16. **PC Code:** 080302 **DP Barcode:** D 389122 **Decision No.:** 402628 **Registration No. :**  264 - RNTI **Petition No.:** 8F7463 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** Single chemical **Case No.:** NA T**XR 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 McNeill y , 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 Heal y , Risk Assessor

Risk Assessment Branch III Health Effects Division (7509P ) **Executive Summary** A cute, chronic , and cancer aggregate dietary exposure and risk assessment s were conducted using the Dietary

Exposure Evaluation Model (DEEM - FCIDTM), Version 2.03, which use s foodFluopyram 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 anal ys e s w ere performed as part of a registration action to support a petition for new uses of fluop yram on apple, banana (import onl y), cherry , dried beans, wine grape, peanut, pistachio, potato, sugar beet, strawberry, tree nuts C rop Group 14 , and watermelon . Acute Dietary

(Food and Drinking Water) Exposure Results and Characterization The acute dietary

anal ys is included tolerance residue levels, 1 00% crop treated assumption and processing factors (empirical and default) . Estimated drinking water concentration (EDWCs) was incorporated directl y into the dietary assessment ( 1 in 10 y

r annual peak of 13 μg/L) and was calculated based on a maximum application rate of 0.446 lb ai/A/season ( cucumber). Estimated acute dietary

exposure to fluopy

ram 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 9 5 th 

### percentile of exp osure is estimated to be 0.0 21 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 fluopy

ram is children 1 - 2 ye ars, with an e stimated exposure at the 95 th 

### percentile of 0.0 4 2 mg/kg/day , equivalent to 8. 4 % of the aPAD. Chronic (Food and Drinking Water) Exposure Results and Characterization The chronic dietary

analysis us ed average residue level s , 100% crop treated assumption, and processing factors (empirical and default) . Estimated drinking water concentration (EDWCs) was incorporated directl y into the dietary assessment ( 1 in 10 y r 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 bel ow HED’s level of concern (<100% ( cPAD) chronic Population Adjusted Dose) for all population subgroups. The dietary exposure is estimated at 0.00 0 42 mg/kg/day for the general U.S. population ( 3.5 % of the cPAD ) and 0.0 0 1 2 mg/kg/day ( 1 0 % of the cPAD) for children 1 - 2 year old s , the population subgroup with the highest estimated chroni c dietary exposure to fluopy

ram . Cancer Aggregate Exposure Results and Characterization The HED Cancer Peer Review C ommittee (CARC) classified fluop yram as “Likely to be Carcinogenic to Human” and recommended the use of linear low dose extrapolation model for risk assessment using a unit risk, Q 1 

### * = 1.55x10 - 2 

### (mg/kg/day) - 1



### . The cancer dietary analysis included average residue levels, projected percent crop treated (PP CT) estimates and processing factors (empirical and default) . Estimated drinking water concentration (EDWCs) was incorporated directly into the dietary

assessment ( 1 in 3 0 y

r 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 (D 387587, D 389081 & September 23 , 2011, L. Cheng) , and thus there are no prior dietary exposure anal ys es conducted. **II. Food**  **Residue Information** Residues of Concern: The nature of the residue in plants is adequatel y 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 enf orcement is fluopy ram, and for risk assessment is fluopy ram 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 fluopy ram and AE C656948 -benzamide. For risk assess ment, the residues of concern in ruminants are fluop yram and its metabolites AE C656948 -benzamide, AE C656948 - E - olefine, AE C656948 - Z - olefine and AE C656948 - 7 - hydroxy, and in hens are fluop yram 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 c ommodities : Almond, hull ................................ ................................ ................................ .......................... 8.0 ppm Apple ................................ ................................ ................................ ................................ .... 0 .30 ppm Apple, wet pomace ................................ ................................ ................................ ............... 0.60 ppm Banana ................................ ................................ ................................ ................................ .... 1.0 ppm Beans, dry ................................ ................................ ................................ ............................ 0 .0 9 ppm Beet, sugar, root ................................ ................................ ................................ ................... 0.0 4 ppm Cherry ................................ ................................ ................................ ................................ .. 0 .6 0 ppm Grape, wine ................................ ................................ ................................ ............................ 2 . 0 ppm Nut, tree, group 14 ................................ ................................ ................................ ............... 0.05 ppm Peanut ................................ ................................ ................................ ................................ ... 0.02 ppm Pistachio ................................ ................................ ................................ ............................... 0.05 ppm Potato ................................ ................................ ................................ ................................ ... 0 .0 2 ppm Potato, processed potato waste ................................ ................................ ............................. 0.08 ppmFluopyram Dietary Exposure and Risk Assessment DP Number: 389122

Page 4 of 40 Straw berry ................................ ................................ ................................ .............................. 1.5 ppm Watermelon ................................ ................................ ................................ ............................ 1.0 ppm Cattle, fat ................................ ................................ ................................ .............................. 0. 1 1 ppm Cattle, meat ................................ ................................ ................................ .......................... 0.15 ppm Cattle, meat byproducts ................................ ................................ ................................ .......... 1.1 ppm Egg ................................ ................................ ................................ ................................ ....... 0. 2 5 ppm Goat, fat ................................ ................................ ................................ ................................ 0. 1 1 ppm Goat, meat ................................ ................................ ................................ ............................ 0.15 ppm Goat, meat byproduct s ................................ ................................ ................................ ........... 1.1 ppm Hog, fat ................................ ................................ ................................ ................................ 0. 0 5 ppm Hog, meat ................................ ................................ ................................ ............................. 0.0 5 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 .0 7 ppm Poultry, fat ................................ ................................ ................................ ............................ 0.20 ppm Poultry, meat ................................ ................................ ................................ ........................ 0.1 5 ppm Poultry, meat byproducts ................................ ................................ ................................ ..... 0 .60 ppm Sheep, fat ................................ ................................ ................................ .............................. 0.11 ppm Sheep, meat ................................ ................................ ................................ .......................... 0.15 ppm Sheep, meat byproduct s ................................ ................................ ................................ ......... 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 Soy bean, forage ................................ ................................ ................................ ...................... 4 .0 ppm Soy bean, hay ................................ ................................ ................................ ........................... 15 ppm Soy bean, seed ................................ ................................ ................................ ....................... 0. 1 0 ppm 

### Residue Data used for the Acute and Chronic Assessment s : 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 y

r annual peak of 13 μg/L). For the c hronic non - cancer dietary anal ys is : average residues , 1 00%CT and processing factors (empirical and default) were us ed . The EDWC was incorporated directl y into the dietary assessment ( 1 in 10 y

r 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 y

r annual mean of 3.5 μg/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 /20 11 ) 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 ba sed 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 fluop yr am, 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 by products (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 D38 7587 , September 23 , 2011 , L. Cheng) . For chronic dietary assessments , the livestock dietary burdens are adjusted with projected percent crop treated estimates provided b y BEAD (see Attachment 2 ). **III. Dr inking 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 /20 11 ) , DP Barcodes 3 53319, 363812, 363820, 363821, 363822, 363824, and 369773 ) and incorporated directl y 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 fluopy ram (Residues O f C oncern Knowledgebase S ubcommittee , D367115, 7/ 16/2009) . The Environmental Fate and Effects Division (EFED) calculated screening level surface water and ground water estimates for fluop yram using PRZM/EXAMS models and the SCI - GROW model, respectivel y. The drinking water models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/ . The EDWCs for fluop yram 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 m aximum use rates of fluopy ram on Florida cucumber scenario and Maine potato scen ario . 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 - ye ar annual mean) . The SCI - GROW model estimated a concentration of 0.319 μg fluop yram/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 E DWCs are recommended.Fluopyram Dietary Exposure and Risk Assessment DP Number: 389122

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### IV. **DEEM -**  **FCIDTM Program and Consumption Information** Fluopy ram acute and chronic dietary exposure assessment s 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 EPA defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicl y available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure asses sment, 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 anal ys is 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 ye ar 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 assessment s , 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 Q 1 

### * . 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., onl y 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 ac cordance with HED policy , per capita exposure and risk are reported for all tier s of anal ysis. 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 fluop yram risk assessment t eam selected a rat acute neurotoxicity study and rat combine d chronic/carcinogenicity s tudy , which provided the most sensitive and protective endpoints from the fluopy

ram 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 forFluopyram Dietary Exposure and Risk Assessment DP Number: 389122

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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 H**  **um an Health Risk**  **Assessments Exposure/**  **Scenario Point of** 

**Departure Uncertainty/** 

**FQPA Safety Factors**  **RfD, PAD, Level**

**of Concern for Risk Assessment**  **Study and Toxicological Effects** Ac ute Dietary (General Population, including Infants and Children) NOAEL= 50

mg/kg/day UF A= 10 x

UF H=10 x FQPA SF=1x Ac ute RfD = 0. 50

mg/kg/day aPAD = 0. 50 mg/kg/day Ac ute 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 wa s 125 mg/kg/day. Ac ute 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 UF A= 10 x

UF H=10 x FQPA SF=1x Chronic RfD =

0.0 12 mg/kg/day cPAD = 0.0 12 mg/kg/day Com bined 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 , Q 1 * =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. UF A = extrapolation from animal to human (interspecies). UF H = 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 anal ys es estimate the dietary exposure of the U.S. population and various population subgroups. The acute and chronic results reported in Table s 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+ ye ars. Results of Acute Dietary

Exposure Analysis E stimated acute dietary

exposure to fluopy

ram from food and drinking water is below HED’s level of concern for all population subgroups . Combined dietary exposure from foo d and drinking water at the 95 th 

### percentile of expo sure 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 fluopy

ram is children 1 - 2 y

rs, with an estimated exposure at the 95 th 

### percentile of 0.04 2 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 resultsFluopyram Dietary Exposure and Risk Assessment DP Number: 389122

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### for all populations at the 95 th 

### , 99 th 

### , and 99.9 th 

### percentiles of exposure are summarized in the Table 2 b elow. **T able**  **2 . Results of Acute Die**  **tary (Food + Drinking Water)**  **Exposure Analysis Using DEEM**  **- FCID**  **Population Subgroup**  **aPAD**

**(m g/kg/day)**  **95 th**  **Percentile 99th Percentile**  **99.9 th**  **Percentile**

**Exposure (m** **g/kg/day) % aPAD**  **Exposure (m** **g/kg/day) % aPAD**  **Exposure (m** **g/kg/day) % aPAD**  General U.S. Population

0. 50 0.02 0741 4.2 0.033456 6.7 0.054800 11 All Infants (< 1 year old) 0.0 38195 7.6 0.063671 13 0.11 2337 22 Children 1 - 2 years old **0.04 2**  **156 8.**  **4** 0.05 4792 1 1 0.0 78116 16 Children 3 - 5 years old 0.03 5136 7. 0 0.0 47878 9.6 0.07 3838 1 5 Children 6 - 12 years old 0.02 4081 4.8 0.03 5065 7.0 0.05 4834 11 Youth 13 - 19 years old 0.01 5398 3. 1 0.024 207 4.8 0.03 7645 7. 5 Adults 20 - 49 years old 0.013 032 2. 6 0.019 434 3.9 0.0 32 439 6.5 Adults 50+ years old 0.01 1141 2. 2 0.01 7676 3. 5 0.0 3 1026 6 . 2 Females 13 - 49 years old 0.01 2844 2. 6 0.0 19692 3.9 0.0 3 2515 6.5 

### Results of Chronic Dietary Exposure Analysis The results of the aggregate chronic dietary anal ysis 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 0.00 0 42 mg/kg/day for the U.S. population ( 3.5 % of the cPAD) and 0.0 0 1 2 mg/kg/day

( 1 0 % of the cPAD) for the most hi ghl y exposed population subgroup ( children 1 - 2 y rs old). Based on a Q 1 

### * = 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.Fluopyram Dietary Exposure and Risk Assessment DP Number: 389122

Page 9 of 40 **Table 3**  **. Summary of Chronic**  **Dietary (Food and Drinking Water) Exposu re 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. 01 2 0.000 423 3.5 0.000 188 2.9 x 10 - 6 All Infants (< 1 year old) 0.00 0800 6.7

NA**2** NA Children 1 - 2 years old **0.001 239**  **1 0**  Children 3 - 5 years old 0.001 0 17 8.5 Children 6 - 12 years old 0.000 574 4.8 Youth 13 - 19 years old 0.000 3 15 2.6 Adults 20 - 49 years old 0.000 3 20 2.7 Adults 50+ years old 0.000 353 2.9 Females 13 - 49 years old 0.000 3 26 2.7 **1** The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and risk is indicated by bold text. **2**NA = 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 PHIpermitted on the proposed label. The chronic dietary risk assessment is considered partially refined and cancer dietary risk assessment i s highl y 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 appli cations, minimum PHI, etc.). A number of experimentally derived processing factor s were used to refine the chronic anal ys e s . Default DEEM processing factors were incorporated for all other processed commodities.Fluopyram Dietary Exposure and Risk Assessment DP Number: 389122

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### VIII. **Conclusions** For acute assessment , food and drinking water are below HED’s level of concern (<100% aPAD) at the 95 th 

### 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 ye ars old, with an estimated exposure at the 95 th 

### percentile of 0.0 4 2 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 0.00 0 42 mg/kg/day

for the general U.S. population ( 3.5 % of the cPAD) and 0.00 1 2 mg/kg/day ( 1 0 % of the cPAD) for children 1 - 2 years old, the population subgroup with the highest estimated chronic dietary exposure to fluopy

ram . 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 Anal ys es Attachment 2 . Livestock Dietary Burdens for Chronic Anal ys is Attachment 3 . Acute Dietary Anal ys is Input File - Food & Water Attachment 4 . Acute Dietary Anal ys is Results - Fo od & Water Attachment 5 . Chronic Dietary Anal ys is Input File - Food & Water Attachment 6 . Chronic Dietary Anal ys is Results - Food & Water Attachment 7 . C ancer Dietary Anal ys is Input File - Food & Water Attachment 8. Cancer Dietary Anal ys is Results - Food & Water Attachment 9 . BEAD Projected Percent Crop Treated Memo (5 /2 3/2011 )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 Classification**  **1 Data**  **Source No. of** 

**Samples No. of** 

**Detectable Residues**  **LO Q**  **%CT Processing**  **Factors Anticipated Residue** 

**Estimates/Tolerance Acute (Tol.,**  **HR ,**  **HAFT, RDF)**  **2 Chronic (Tol.,** 

**AR) 2**  Al mond Al mond oil Al mond 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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12 **Data and Residue Estimates Used in Dietary Analyses** 

**RAC Classification**  **1 Data**  **Source No. of** 

**Samples No. of** 

**Detectable Residues**  **LO Q**  **%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 .1 x. 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

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13 **Data and Residue Estimates Used in Dietary Analyses** 

**RAC Classification**  **1 Data**  **Source No. of** 

**Samples No. of** 

**Detectable Residues**  **LO Q**  **%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. 6 0 (Tol) 0.19 (AR) Chestnut PB Al mond 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 0.01 x (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 chronicFluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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14 **Data and Residue Estimates Used in Dietary Analyses** 

**RAC Classification**  **1 Data**  **Source No. of** 

**Samples No. of** 

**Detectable Residues**  **LO Q**  **%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) 0.0 1 (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

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15 **Data and Residue Estimates Used in Dietary Analyses** 

**RAC Classification**  **1 Data**  **Source No. of** 

**Samples No. of** 

**Detectable Residues**  **LO Q**  **%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 Al mond 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

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16 **Data and Residue Estimates Used in Dietary Analyses** 

**RAC Classification**  **1 Data**  **Source No. of** 

**Samples No. of** 

**Detectable Residues**  **LO Q**  **%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 0.0 13 0.00 49 (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 o f 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

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17 **Data and Residue Estimates Used in Dietary Analyses** 

**RAC Classification**  **1 Data**  **Source No. of** 

**Samples No. of** 

**Detectable Residues**  **LO Q**  **%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 0.0 7 (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 residueFluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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 0.014Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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19 

### Attachment **2. Livestock Dietary Burdens for Chronic Analysis Calculation of Dietary Burdens of Fluopyram**  **Residues to Livestock for Chronic Dietary Exposure.** Feedstuff Type 1 % 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** Al mond, 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 Al falfa, meal PC 89 5 0.16 4 0.0003 Untreated PC -- 5 -- -- TOTAL BURDEN -- -- 100 -- -- **0.036 Sw**  **ine: 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 swin e.Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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 - 2 011/14:56:51/8 Reference dose (aRfD) = 0.5 mg/kg bw/day Comment: Tolerance residues 2011 - 08 - 08 crops 13 ppb water

-------------------------------------------------------------------------------- EPA Crop Def Res A dj.Factors Comment Code Grp Food Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 14000030 14 Almond 0.050000 1.000 1.000 1400003 1 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 6 C 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 1.000Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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 C hicken, 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 0.6 00000 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 Ch icken, 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 0.09 0000 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 C orn, 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 1.5 00000 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 Eg g, 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 0.25 0000 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 Goa t, 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 1.100 000 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 M ilk, 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 0.0 70000 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 Oa t, 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 1.50 0000 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 Pea nut, 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 0.050 000 1.000 1.000Fluopyram 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 P otato, 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 0.0 20000 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 Po ultry, 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 0.20 0000 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 Rap eseed, 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 0.150 000 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 Shee p, 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 T urkey, 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 0.2 00000 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 Wa lnut 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 1.000Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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 d ata) 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 0.11 0000 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 0.400Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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 95000 230 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 0.01 0000 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 Be an, 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 1.00 0 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 Be et, 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 1.00 0 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 Ch icken, 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 0.85 0 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 0.010Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Page 25 of 40 15001241 15 Co rn, 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 Eg g, 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 0.50 0 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 Me at, 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 solid s 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 Oa t, 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 1.00 0 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 Po tato, 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 0.640Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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 Po ultry, 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 1.00 0 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 So ybean, 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 1.00 0 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 Tu rkey, 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 1.00 0 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 Wh eat, 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 waterFluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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% Chi ldren 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(A cute): .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

-------- ---- ------------------------------- ---------- ------ ------ ------- 140000 30 14 Almond 0.010000 1.000 0.330Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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 Barl ey, 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 06030 380 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 - babyf ood 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 Cash ew 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 40000 931 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 byproduc ts - 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 0.070Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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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 70001 450 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) - ba byfood 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 15002 320 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 oat s - 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, mea t - 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 1.000Fluopyram 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 Pota to, 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 60003 040 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 Soyb ean, 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 15003 810 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, s kin 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 0.010Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Page 31 of 40 

### Attachment 8 **. Ca**  **ncer 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* = 0.0 155 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 2.4 8E - 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+ (n ot 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 - 06Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Page 32 of 40 

### Attachment **9 .**  **BEAD Projected Percent Crop Treated Me mo (**  **5 /** **2 3/20**  **11 )**  **UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

WASHINGTON D.C., 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION **ME MORANDUM**  **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: Ma** **y 4, 2011**  **I. SUMMARY**  In this memo BEAD is providing percent crop treated for new use (PCTn) estimates of the fungicide fluopyram for c antaloupe, cucumber, dry beans, p eanuts, p otatoes, p um pkin, squash, s ugar b eet s , 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 f or 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. Com parisons are only mad e among pesticides of the same pesticide types (e.g., the market leader for fungicides on the use crop is selected for comparison with a ne w fungicide). The market leader included in the estimation may not be the same for each year since different pestici des may dominate at different times. Ty pically, 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 an d 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 exceptiona lly 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 ne w pesticide in comparison with the market leaders, w hether or not the market leaders are well established 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 co mp arison 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. T he 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, straw berries, 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 c antaloupe, cucumber, peanuts, p otatoes, p um pkin, 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 Waterm elon**  .Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Page 34 of 40 **Crop M**  **arket L**  **eader (ML) Chem** **ical Avg**  **ML PCTn**  **Max ML**  **PCTn** Cantaloupe b Sulfur

Triflumizole **22 31**  Cucumber

b Chlorothalonil **41 52**  

### Dry Bean s a Thiophanate - Methyl

Py raclostrobin **7 14**  Peanut s b Chlorothalonil

Mancozeb **67 70**  

### Potato es b Mancozeb

Chlorothalonil **64 64**  Pum pkin b Chlorothalonil **45 57**  Squash

b Chlorothalonil **47 54**  

### Sugar B eet s a Tetraconazole

Py raclostrobin **48 53**  Watermelon

b Chlorothalonil **54 58**  

###  a Proprietary data (2006 - 2010)  b NASS data (2002 - 2006) **IV. Evaluation of BCS PPCT Estim**  **ates 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 C**  **om pared to BCS**  **PPCTs for C**  **antaloupe, C**  **ucumber, D**  **ry B**  **eans, P**  **eanuts, P**  **otatoes, P**  **umpkin, S**  **quash, S**  **ugar B**  **eets, and W**  **aterm elon**  **Crop M**  **arket L**  **eader (ML) Chem** **ical BEAD Avg**  **ML PCTn**  **BCS PPCTs Difference**  **(%)** Cantaloupe b Sulfur/Triflumizole **22 34**  **55** Cucumber

b Chlorothalonil **41 47**  **15** Dry Beans a Thiophanate - Methyl/

Py raclostrobin **7 10**  **43** Peanut s b Chlorothalonil/Mancozeb **67 67**  **0** 

### Potato es b Mancozeb/ Chlorothalonil **64 60**  **- 6**  Pum pkin b Chlorothalonil **45 50**  **11** Squash

b Chlorothalonil **47 54**  **15** 

### Sugar beet s a Tetraconazole/Pyraclostrobin **48 46**  **- 4**  Watermelon

b Chlorothalonil **54 59**  **9**  a Proprietary data (200 6 - 20 1 0)  b NASS data (200 2 - 200 6 ) In order to evaluate the methodology BCS used to determine PPCTs for rotated crops (w heat, 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 PPC Ts 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 ( 200 6 - 20 1 0 ) 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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Page 35 of 40 The BCS methodology assumed that e ach rotational crop is plante d 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, w here 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 m

ultiplying 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 . T he PCTn for these rotational crops that follows the treated acreage of dry beans and potatoe s , 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) w hich 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 b**  **y Rotational Crops**  **Data Items**  **2010 2009**  **2008 2007**  **2006 5 Year**  **Avg. BEAD** 

**PCTn Tr**  **ea t**  **e d.** 

**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 *P roprietary Data (2004 - 2008) **NASS (2003)

**T able**  **4 . P**  **CTn for Rotated Crops**Fluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Page 36 of 40 **Data Item s**  **Dry Beans and Potato es** 

**Acres Treated 5 Year Avg.**  **PCTn Rotated Crops** Wheat 8 08 ,000 5 9 , 000 , 0 00 **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 , 0 00 **23** Rye 808 ,000 1, 000 , 0 00 **63** Millet 808 ,000 482,000 **100** Soy beans 808 ,000 74, 000 , 0 00 **1** Canola 808 ,000 1, 000 , 000 **73** Cotton 808 ,000 11, 000 , 000 **7** Alfalfa 808 ,000 2 0 , 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 i ndicate 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 wo uld 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), w hich 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 o f 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. Comm** **odity 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 cicho racearum ) 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 spotFluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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Page 37 of 40 ( 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 betico la ); Powdery mildew (Erysiphe polygoni) In addition, HED requested fluopyram PCTn for rotational crops that are alfalfa, c anola, 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, pum pkin, 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. T wo o f 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 high risk - 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 wo uld 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 indic ates that pyraclostrobin and thiophanate - me thyl 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 rank s 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 lead er 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 wo uld 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 ne eds 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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Page 38 of 40  Pest pressure: No FIFRA Section 18 Emergency Exem ption 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 lead er levels on peanuts. In particular, fluopyram will unlikely gain a large portion of the market whe n it competes with the market leaders that have been extensively used to control the same diseases. It is also because fluopyram competes with other fungic ide 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 b een 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 alternative s 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 py raclostrobin 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 disease s. 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 cle ar 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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Page 39 of 40 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 beli eves 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, Straw berries, 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, 200 6 - 20 1 0. FRAC, 2011 . Fungicide Resistance Action Committee. http://www.frac.info/frac/index.htm cc: Cynthia Giles - Parker; Barbara Madden; Paula DeschampFluopyram Dietary Exposure and Risk Assessment DP Number: D389122

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