

                                       
                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C.  20460
                                       
	OFFICE OF CHEMICAL SAFETY
	AND POLLUTION PREVENTION
                                                                               
MEMORANDUM

DATE:  	September 29, 2011

SUBJECT:	Fluopyram: Acute, Chronic, and Cancer Aggregate Dietary Exposure and Risk Assessments for Section 3 Registration for Use on Apple, Banana (Import only), Dried Beans, Cherry, Grape (Wine Production only), Peanut, Pistachio, Potato, Sugar Beet, Strawberry, Tree Nuts Crop Group 14, Watermelon, and Rotational Crops Alfalfa, Canola, Cotton, Cereal Grains (Except Rice) Crop Group 15, and Forage of Cereal Grains (Except Rice) Crop Group 16.
 
PC Code:  080302
DP Barcode:  D389122 
Decision No.: 402628
Registration No.: 264-RNTI
Petition No.: 8F7463
Regulatory Action: Section 3 Registration
Risk Assessment Type: Single chemical
Case No.: NA
TXR No.: NA
CAS No.: 658066-35-4
MRID No.: NA
40 CFR:   180.XXX

REVIEWER:	Leung Cheng, Chemist
            Risk Assessment Branch III
            Health Effects Division (7509P)

THROUGH:	Dennis McNeilly, Chemist
		David Hrdy, Biologist
            Dietary Exposure Science Advisory Council (DESAC)
            Health Effects Division (7509P)
            
		Paula Deschamp, Branch Chief
		Risk Assessment Branch III
            Health Effects Division (7509P)
            
TO:		Sheila Healy, Risk Assessor
		Risk Assessment Branch III
            Health Effects Division (7509P)


Executive Summary

Acute, chronic, and cancer aggregate dietary exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model (DEEM-FCID(TM)), Version 2.03, which uses food 
consumption data from the U.S. Department of Agriculture's Continuing Surveys of Food Intakes 
by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed as part of a 
registration action to support a petition for new uses of fluopyram on apple, banana (import only),
cherry, dried beans, wine grape, peanut, pistachio, potato, sugar beet, strawberry, tree nuts Crop Group 14, and watermelon. 
 
Acute Dietary (Food and Drinking Water) Exposure Results and Characterization

The acute dietary analysis included tolerance residue levels, 100% crop treated assumption and processing factors (empirical and default).  Estimated drinking water concentration (EDWCs) was incorporated directly into the dietary assessment (1 in 10 yr annual peak of 13ug/L) and was calculated based on a maximum application rate of 0.446 lb ai/A/season (cucumber).

Estimated acute dietary exposure to fluopyram from food and drinking water is below HED's level of concern for all population subgroups (<100% (aPAD) acute Population Adjusted Dose).  Combined dietary exposure from food and drinking water at the 95[th] percentile of exposure is estimated to be 0.021 mg/kg/day for the overall U.S. population, equivalent to 4.2% of the aPAD.  The population subgroup with the highest estimated acute dietary exposure to fluopyram is children 1-2 years, with an estimated exposure at the 95[th] percentile of 0.042 mg/kg/day, equivalent to 8.4% of the aPAD.

Chronic (Food and Drinking Water) Exposure Results and Characterization

The chronic dietary analysis used average residue levels, 100% crop treated assumption, and processing factors (empirical and default).  Estimated drinking water concentration (EDWCs) was incorporated directly into the dietary assessment (1 in 10 yr annual mean of 4.9 ug/L) and was calculated based on a maximum application rate of 0.356 lb ai/A/season (potato).

Chronic dietary exposure estimates for food and drinking water are well below HED's level of concern (<100% (cPAD) chronic Population Adjusted Dose) for all population subgroups.  The dietary exposure is estimated at 0.00042 mg/kg/day for the general U.S. population (3.5% of the cPAD) and 0.0012 mg/kg/day (10% of the cPAD) for children 1-2 year olds, the population subgroup with the highest estimated chronic dietary exposure to fluopyram.  

Cancer Aggregate Exposure Results and Characterization

The HED Cancer Peer Review Committee (CARC) classified fluopyram as "Likely to be Carcinogenic to Human" and recommended the use of linear low dose extrapolation model for risk assessment using a unit risk, Q1* = 1.55x10[-2] (mg/kg/day) [-1].  The cancer dietary analysis included average residue levels, projected percent crop treated (PPCT) estimates and processing factors (empirical and default).  Estimated drinking water concentration (EDWCs) was incorporated directly into the dietary assessment (1 in 30 yr annual mean of 3.5 ug/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 .    


I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the point of departure (POD; e.g., NOAEL, LOAEL) divided by the appropriate uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  "Available Information on Assessing Exposure from Pesticides, A User's Guide," 6/21/2000, web link:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (8/20/99).

The petition represents the first food use for fluopyram (D387587, D389081 & September 23, 2011, L. Cheng), and thus there are no prior dietary exposure analyses conducted.

II.	Food Residue Information

Residues of Concern:  The nature of the residue in plants is adequately understood based on metabolism studies with grape, potato, bean, and red pepper.  HED has determined that the residue of concern in plant commodities (primary and rotational crop) for tolerance enforcement is fluopyram, and for risk assessment is fluopyram in all crops except in legumes and oilseed crops when AE C656948-benzamide is also included.  

The nature of the residue in livestock is adequately understood based on metabolism studies with goats and hens.  For tolerance enforcement, HED has determined that the residues of concern are fluopyram and AE C656948-benzamide.  For risk assessment, the residues of concern in ruminants are fluopyram and its metabolites AE C656948-benzamide, AE C656948-E-olefine, AE C656948-Z-olefine and AE C656948-7-hydroxy, and in hens are fluopyram and its metabolites AE C656948-benzamide, AE C656948-E-olefine, and AE C656948-Z-olefine. 

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

      Almond, hull	8.0 ppm
      Apple	0.30 ppm
      Apple, wet pomace	0.60 ppm
      Banana	1.0 ppm
      Beans, dry	0.09 ppm
      Beet, sugar, root	0.04 ppm
      Cherry	0.60 ppm
      Grape, wine	2.0 ppm
      Nut, tree, group 14	0.05 ppm
      Peanut	0.02 ppm
      Pistachio	0.05 ppm
      Potato	0.02 ppm
      Potato, processed potato waste	0.08 ppm
      Strawberry	1.5 ppm
      Watermelon	1.0 ppm
      Cattle, fat	0.11 ppm
      Cattle, meat	0.15 ppm
      Cattle, meat byproducts	1.1 ppm
      Egg	0.25 ppm
      Goat, fat	0.11 ppm
      Goat, meat	0.15 ppm
      Goat, meat byproducts	1.1 ppm
      Hog, fat	0.05 ppm
      Hog, meat	0.05 ppm
      Hog, meat byproducts	0.70 ppm
      Horse, fat	0.11 ppm
      Horse, meat	0.15 ppm
      Horse, meat byproducts	1.1 ppm
      Milk	0.07 ppm
      Poultry, fat	0.20 ppm
      Poultry, meat	0.15 ppm
      Poultry, meat byproducts	0.60 ppm
      Sheep, fat	0.11 ppm
      Sheep, meat	0.15 ppm
      Sheep, meat byproducts	1.1 ppm
      
In addition, the following rotational crop tolerances are recommended:

      Alfalfa, forage	0.45 ppm
      Alfalfa, hay	1.1 ppm
      Canola, seed	1.8 ppm
      Cotton, gin byproducts	0.05 ppm
      Cotton, undelinted seed	0.01 ppm
      Grain, cereal, group 15, except rice	1.5 ppm
      Grain, cereal, forage, fodder and straw, group 16, except rice; forage	4.0 ppm
      Grain, cereal, forage, fodder and straw, group 16, except rice; hay, straw and stover	7.0 ppm
      Soybean, forage	4.0 ppm
      Soybean, hay	15 ppm
      Soybean, seed	0.10 ppm

Residue Data used for the Acute and Chronic Assessments:  

For the acute dietary analysis: included tolerance residue levels, 100% crop treated assumption and processing factors (empirical and default).  The EDWC was incorporated directly into the dietary assessment (1 in 10 yr annual peak of 13ug/L).

For the chronic non-cancer dietary analysis: average residues, 100%CT and processing factors (empirical and default) were used.  The EDWC was incorporated directly into the dietary assessment (1 in 10 yr annual mean of 4.9 ug/L).

For the cancer dietary assessment: average residues, projected percent crop treated, and empirical and default processing factors were used.  The EDWC was incorporated directly into the dietary assessment (1 in 30 yr annual mean of 3.5ug/L).

Percent Crop Treated:

Projected %CT data (J. Alsadek and C. Chen, 5/23/2011) were used to refine anticipated residues for the cancer assessment.  To calculate these projected percent crop treated values, BEAD used recent data from the National Statistics Service (NASS) 2002-2006, and recent proprietary data (2006-2010).  The estimates for the primary crops are based on the market leader approach involving several registered fungicides, and the estimates for the rotational crops are based on the total acreage available from treated rotatable crops (dry beans and potato); see Attachment 9.  
Livestock commodities:  

There are livestock feedstuffs associated with the proposed uses of fluopyram, and the following ones are considered important:  alfalfa hay, alfalfa meal, almond hulls, canola meal, field/sweet corn forage/silage, sorghum grain, sugar beet molasses, and wheat milled byproducts (email, J. Stokes, 5/16/2011).  The estimated dietary burdens for tolerance setting are 1.90 ppm for beef cattle, 3.39 ppm for dairy cattle, 1.24 ppm for poultry, and 1.33 ppm for swine (see D387587, September 23, 2011, L. Cheng).  For chronic dietary assessments, the livestock dietary burdens are adjusted with projected percent crop treated estimates provided by BEAD (see Attachment 2).  
 
III.    Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (M. Ruhman, 7/8/2011), DP Barcodes 353319, 363812, 363820, 363821, 363822, 363824, and 369773) and incorporated directly into this dietary assessment.  Water residues were incorporated in the DEEM-FCID into the food categories "water, direct, all sources" and "water, indirect, all sources."

The residue of concern in drinking water for this single chemical risk assessment is fluopyram (Residues Of Concern Knowledgebase Subcommittee, D367115, 7/16/2009).  The Environmental Fate and Effects Division (EFED) calculated screening level surface water and ground water estimates for fluopyram using PRZM/EXAMS models and the SCI-GROW model, respectively.  The drinking water models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/.  

The EDWCs for fluopyram were calculated for ground and surface drinking water using the Tier II (PRZM/EXAMS) surface water modeling and Tier I (SCI-GROW) ground water modeling based on the proposed maximum use rates of fluopyram on Florida cucumber scenario and Maine potato scenario.  The surface water estimates are 13.0 ug/L for acute concentration (1-in-10 year annual peak), 4.90 ug/L for chronic concentration (1-in-10 year mean), and 3.49 ug/L for cancer concentration (30-year annual mean).  The SCI-GROW model estimated a concentration of  0.319 ug fluopyram/L in ground water.  Surface water EDWCs were used in the dietary assessment, since they were higher than those for ground water.  For the human health risk assessment, the highest relevant EDWCs are recommended. 


IV.	DEEM-FCID(TM) Program and Consumption Information

Fluopyram acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID(TM), 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 publicly available recipe translation files developed jointly by 
USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are 
retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the 
general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessments, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The 
resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For cancer dietary exposure assessments, the estimated exposure of the general U.S. population is multiplied by the Q1*.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or "matched" in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for highly refined assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment. 

V.	Toxicological Information 

The fluopyram risk assessment team selected a rat acute neurotoxicity study and rat combined chronic/carcinogenicity study, which provided the most sensitive and protective endpoints from the fluopyram database, to employ in the risk assessment for acute and chronic dietary exposure scenarios (TOXSAC memo,12/23/2009).  The doses and toxicological endpoints selected for dietary risk assessment are summarized in Table 1.

Table 1. Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Dietary Human Health Risk Assessments
Exposure/
Scenario
                              Point of Departure
                        Uncertainty/FQPA Safety Factors
                RfD, PAD, Level of Concern for Risk Assessment
                        Study and Toxicological Effects
Acute Dietary (General Population, including Infants and Children)
NOAEL= 50 mg/kg/day
UFA= 10 x
UFH=10 x
FQPA SF=1x


Acute RfD = 0.50  mg/kg/day

aPAD = 0.50  mg/kg/day
Acute Neurotoxicity Study in Rats.  
The LOAEL of 100 mg/kg in females is based on decreased motor and locomotor activity in females.  The LOAEL in males was 125 mg/kg/day.
Acute Dietary
(Females 13-49 years of age)

An endpoint attributable to a single dose exposure has not been identified for subpopulation.
Chronic Dietary (All Populations)
NOAEL= 1.2 mg/kg/day
UFA= 10 x
UFH=10 x
FQPA SF=1x


Chronic RfD = 0.012
mg/kg/day

cPAD = 0.012 mg/kg/day
Combined Chronic/Carcinogenicity in Rats.
The LOAEL of 6.0 mg/kg/day is based on nephropathy in the kidney, follicular cell hypertrophy in the thyroid, and increased liver weight with gross pathological and histopathological findings. 
Cancer (oral, dermal, inhalation)
Based on the liver tumor in female rats and thyroid tumor in male rats, the CARC classified fluopyram as a "Likely to be Carcinogenic to Human" and recommended the use of linear low dose extrapolation model for risk assessment using a unit risk, Q1[*] =1.55x10[-2] (mg/kg/day)[-1]
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.  MOE = margin of exposure.  LOC = level of concern.  N/A = not applicable.

VI.	Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID(TM) analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The acute and chronic results reported in Tables 2 and 3 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  

Results of Acute Dietary Exposure Analysis

Estimated acute dietary exposure to fluopyram from food and drinking water is below HED's level of concern for all population subgroups.  Combined dietary exposure from food and drinking water at the 95[th] percentile of exposure is estimated to be 0.021 mg/kg/day for the overall U.S. population, equivalent to 4.2% of the aPAD.  The population subgroup with the highest estimated acute dietary exposure to fluopyram is children 1-2 yrs, with an estimated exposure at the 95[th] percentile of 0.042 mg/kg/day, equivalent to 8.4% of the aPAD.  When comparing the per capita to per user exposures, no significant differences were found for all population subgroups.  The results for all populations at the 95[th], 99[th], and 99.9[th] percentiles of exposure are summarized in the Table 2 below.

 Table 2.  Results of Acute Dietary (Food + Drinking Water) Exposure Analysis Using DEEM-FCID 
                              Population Subgroup
                                aPAD (mg/kg/day)
                               95[th] Percentile
                                99th Percentile
                              99.9[th] Percentile
 
 
                              Exposure (mg/kg/day)
                                     % aPAD
                              Exposure (mg/kg/day)
                                     % aPAD
                              Exposure (mg/kg/day)
                                     % aPAD
General U.S. Population
                                      0.50
                                    0.020741
                                      4.2
                                    0.033456
                                      6.7
                                    0.054800
                                       11
All Infants 
(< 1 year old)
                                        
                                    0.038195
                                      7.6
                                    0.063671
                                       13
                                    0.112337
                                       22
Children 1-2 years old
                                        
                                    0.042156
                                      8.4
                                    0.054792
                                       11
                                    0.078116
                                       16
Children 3-5 years old
                                        
                                    0.035136
                                      7.0
                                    0.047878
                                      9.6
                                    0.073838
                                       15
Children 6-12 years old
                                        
                                    0.024081
                                      4.8
                                    0.035065
                                      7.0
                                    0.054834
                                       11
Youth 13-19 years old
                                        
                                    0.015398
                                      3.1
                                    0.024207
                                      4.8
                                    0.037645
                                      7.5
Adults 20-49 years old
                                        
                                    0.013032
                                      2.6
                                    0.019434
                                      3.9
                                    0.032439
                                      6.5
Adults 50+ years old
                                        
                                    0.011141
                                      2.2
                                    0.017676
                                      3.5
                                    0.031026
                                      6.2
Females 13-49 years old
                                        
                                    0.012844
                                      2.6
                                    0.019692
                                      3.9
                                    0.032515
                                      6.5
 
 Results of Chronic Dietary Exposure Analysis
 
 The results of the aggregate chronic dietary analysis for food and drinking water are below the Agency's level of concern (<100% cPAD) for all population subgroups.  Chronic dietary exposure was estimated at 0.00042 mg/kg/day for the U.S. population (3.5% of the cPAD) and 0.0012 mg/kg/day (10% of the cPAD) for the most highly exposed population subgroup (children 1-2 yrs old).  
 
 Based on a Q1* = 1.55x10[-2] (mg/kg/day) [-1], the cancer risk was estimated at 2.9 x10[-][6] with exposure from drinking water accounted for 1.1 x10[-][6] .  The estimated chronic exposures/risks for food and water are summarized in Table 3 for all populations.
 

 Table 3.  Summary of Chronic Dietary (Food and Drinking Water) Exposure and Risk for Fluopyram
                              Population Subgroup

                               cPAD (mg/kg/day)
                                Chronic Dietary
                                     Cancer
                                        
                                        
                               Dietary Exposure 
                                  (mg/kg/day)
                                     % cPAD
                                Dietary Exposure
                                  (mg/kg/day)
                                      Risk
                               Q* = 1.55 x 10[-2]
 General U.S. Population

                                     0.012
                                    0.000423
                                      3.5
                                    0.000188
                                  2.9 x 10[-6]
 All Infants (< 1 year old)
                                       
                                    0.000800
                                      6.7
                                     NA[2]
                                       NA
 Children 1-2 years old
                                       
                                    0.001239
                                       10
                                        
                                        
 Children 3-5 years old
                                       
                                    0.001017
                                      8.5
                                        
                                        
 Children 6-12 years old
                                       
                                    0.000574
                                      4.8
                                        
                                        
 Youth 13-19 years old
                                       
                                    0.000315
                                      2.6
                                        
                                        
 Adults 20-49 years old
                                       
                                    0.000320
                                      2.7
                                        
                                        
 Adults 50+ years old
                                       
                                    0.000353
                                      2.9
                                        
                                        
 Females 13-49 years old
                                       
                                    0.000326
                                      2.7
                                        
                                        
[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 PHI permitted on the proposed label.  The chronic dietary risk assessment is considered partially refined and cancer dietary risk assessment is highly refined.  Anticipated residues for all the proposed food commodities were based on field trial data.  Although field trial data provide more refined exposure estimates than tolerances, the results may still be considered somewhat conservative, since field trials are conducted under maximum use conditions (maximum allowed application rate and number of applications, minimum PHI, etc.).  

A number of experimentally derived processing factors were used to refine the chronic analyses.  Default DEEM processing factors were incorporated for all other processed commodities.  

    

   VIII.		Conclusions
 
For acute assessment, food and drinking water are below HED's level of concern (<100% aPAD) at the 95th percentile of exposure.  Combined dietary exposure from food and drinking water is estimated to be 0.021 mg/kg/day for the overall U.S. population, equivalent to 4.2% of the aPAD.  The population subgroup with the highest estimated acute dietary exposure to is children 1-2 years old, with an estimated exposure at the 95[th] percentile of 0.042 mg/kg/day, equivalent to 8.4% of the aPAD.

Chronic dietary exposure estimates for food and water are well below HED's level of concern (<100% cPAD) for all population subgroups.  The dietary exposure is estimated at 0.00042 mg/kg/day for the general U.S. population (3.5% of the cPAD) and 0.0012 mg/kg/day (10% of the cPAD) for children 1-2 years old, the population subgroup with the highest estimated chronic dietary exposure to fluopyram.  

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

 IX.		List of Attachments
 
Attachment 1.  Data and Residue Estimates Used in Dietary Analyses
Attachment 2.  Livestock Dietary Burdens for Chronic Analysis
Attachment 3.  Acute Dietary Analysis Input File - Food & Water
Attachment 4.  Acute Dietary Analysis Results - Food & Water
Attachment 5.  Chronic Dietary Analysis Input File - Food & Water
Attachment 6.  Chronic Dietary Analysis Results - Food & Water
Attachment 7.  Cancer Dietary Analysis Input File - Food & Water
Attachment 8.  Cancer Dietary Analysis Results - Food & Water
Attachment 9.  BEAD Projected Percent Crop Treated Memo (5/23/2011)

 

   



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
                                      LOQ
                                      %CT
                                  Processing
                                    Factors
Anticipated Residue Estimates/Tolerance



                                       
                                       
                                       
                                       

Acute (Tol., HR, HAFT, RDF) 2
Chronic (Tol., AR)[2]
Almond
Almond oil
Almond hulls
PB
B
PB
Field Trial Data 47567020
                                      20
                                       4
                                       4
                                      20
                                     0.01
                                      33
                                       
0.05 (Tol)
0.05 (Tol)
8.0 (Tol)
0.01 (AR)
0.01 (AR)
3.08 (AR)
Apple
NB, PB
Field Trial Data 47567032
                                      58
                                      58
                                     0.01
                                      40
                                  Washed 0.7x
                                 Peeled 0.03x
                                  Dried 0.03x
                                  Juice 0.4x
                               Applesauce 0.01x
                                   47567111
0.30 (Tol)
0.11 (AR)
Banana
NB, PB
Field Trial Data 47567036
                                      28
                                      28
                                     0.01
                                       
                                       
1.0 (Tol)
0.02 (AR)
Barley
B
Wheat Field Trial Data 47567015
                                      30
                                      30
                                     0.01
                                      22
                                       
1.5 (Tol)
0.22 (AR)
Bean, dry
Bean, black, seed
Bean, broad, seed
Bean, cowpea, seed
Bean, great northern, seed
Bean, kidney, seed
Bean, lima, seed
Bean, mung, seed
Bean, navy, seed
Bean, pink, seed
Bean, pinto, seed
B
Dry Bean Seed Field Trial Data 47567029
                                      18
                                      11
                                     0.01
                                       7
                                       
0.09 (Tol)
0.01 (AR)
The benzamide to fluopyram ratio from the bean metabolism study is 5.1x. Thus, the parent residues in dry beans are adjusted with a 6.1x factor for acute and chronic
Beet, sugar
B
Field Trial Data 47567010
                                      24
                                      24
                                     0.01
                                      48
                              Refined sugar 1.3x
                                 Molasses 0.9x
                                   47567120
0.04 (Tol)
0.01 (AR)
Brazil nut
PB
Pecan Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Buck wheat
B
Wheat Field Trial Data 47567015
                                      30
                                      30
                                     0.01
                                       
                                       
1.5 (Tol)
0.22 (AR)
Butternut
PB
Pecan Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Cashew
PB
Pecan Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Cherry
PB
Field Trial Data 47567033
                                      12
                                      12
                                     0.01
                                      49
                                       
0.60 (Tol)
0.19 (AR)
Chestnut
PB
Almond Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Chickpea
B
Dry Bean Seed Field Trial Data 47567029
                                      18
                                      11
                                     0.01
                                       7
                                       
0.09 (Tol)
0.01 (AR) - see note under dry beans
Corn, field
Corn, pop
Corn, sweet
B
Field Trial Data 47567014
                                      30
                                      18
                                       2
                                       0
                                     0.01
                                       1

                                  Bran 2.64x
                                  Flour 0.85x
                                   Meal 0.8x
                    Refined oil 0.59x, 0.11x (aver = 0.35x)
                                 Starch 0.15x
                                   47567117
1.5 (Tol)
Field & pop corn 0.01 (AR)
Sweet corn 0.005 (AR)
Cottonseed
B
Field Trial Data 47567125
                                      22
                                       0
                                     0.01
                                       7
                         <0.01 ppm from 5x use rate
                                   47567122
                               Refined oil 0.01x
                  (rapeseed oil processing data in 47567116) 
                                       
0.01 (Tol)
0.01 (AR)
The EU canola field trials show that the maximum benzamide residues compared to fluopyram represented 50%. Thus, the parent residues in cottonseed are adjusted by 1.5 for acute and chronic
Filbert
PB
Pecan Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Grape, wine
PB
Field Trial Data 47372604
                                      32
                                      32
                                     0.01
                                      79
                                  Juice 0.5x 
                                 Raisins 2.4x
                                  Washed 0.8x
2.0 (Tol)
0.40 (AR)
Guar seed
B
Dry Bean Seed Field Trial Data 47567029
                                      18
                                      11
                                     0.01
                                       7
                                       
0.09 (Tol)
0.01 (AR) - see note under dry beans
Hickory nut
PB
Pecan Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Lentil
B
Dry Bean Seed Field Trial Data 47567029
                                      18
                                      11
                                     0.01
                                       7
                                       
0.09 (Tol)
0.01 (AR)  - see note under dry beans
Macademia nut
PB
Pecan Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Millet
B
Sorghum Field Trial Data 47567015
                                      24
                                      24
                                     0.01
                                       
                                       
1.5 (Tol)
0.62 (AR)
Oat
B
Wheat Field Trial Data 47567015
                                      30
                                      30
                                     0.01
                                      23
                                       
1.5 (Tol)
0.22 (AR)
Peanut
B
Field Trial Data 47567019
                                      24
                                       4
                                     0.01
                                      67
                                 Butter 0.22x
                                  Meal 0.19x
                               Refined oil 0.25x
                                 Roasted 0.26x
                                   47567114
0.02 (Tol)
0.011 (AR)
Pecan
PB
Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Pistachio
PB
Almond Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Potato
NB, PB
Field Trial Data 47567012
                                      32
                                       2
                                     0.01
                                      64
                              Peeled tubers 0.2x
                              Washed tubers 0.7x
                               Potato chips 0.3x
                              Granules/flakes 1x
                                   47567118
0.02 (Tol)
0.01 (AR)
Rape seed oil/canola oil
B
Field Trial Data 47567013
                                      16
                                      16
                                     0.01
                                      73
                               Canola meal 0.3x
                               Refined oil 0.01x
                                   47567116
1.8 (Tol)
0.51 (AR)
The EU canola field trials show that the maximum benzamide residues compared to fluopyram represented 50%. Thus, the parent residues in canola/rapeseed are adjusted by 1.5 for acute and chronic
Rye
B
Wheat Field Trial Data 47567015
                                      30
                                      30
                                     0.01
                                      63
                                       
1.5 (Tol)
0.22 (AR)
Sorghum
B
Field Trial Data 47567015
                                      24
                                      24
                                     0.01
                                      12
                                       
1.5 (Tol)
0.62 (AR)
Soybean
B
Field Trial Data 47567016
                                      40
                                      15
                                     0.01
                                       1
                                  Flour 0.04x
                                  Meal 0.05x
                                  Milk 0.01x
                               Refined oil 0.02x
                                   47567119
0.10 (Tol)
0.024 (AR)
Strawberry
PB
Field Trial Data 47372605
47372615 (EU greenhouse)
                                   20 (drip)
                                8 (green house)
                                       8
                                       8
                                     0.01
                                      71
                                       
1.5 (Tol)
0.026 (AR)
0.35 (AR)
Ave = 0.19
Triticale
B
Wheat Field Trial Data 47567015
                                      30
                                      30
                                     0.01
                                       
                                  Flour 0.12x
1.5 (Tol)
0.22 (AR)
Walnut
PB
Pecan Field Trial Data 47567020
                                      20
                                       4
                                     0.01
                                       
                                       
0.05 (Tol)
0.01 (AR)
Watermelon
NB, PB
Muskmelon Field Trial Data 47567030
                                      12
                                      12
                                     0.01
                                      54
                     Peeled 0.044x (from foliar treatment)
1.0 (Tol)
0.22 (AR)
Wheat 
B
Field Trial Data 47567015
                                      30
                                      30
                                     0.01
                                       1
                               Wheat flour 0.12x
                                Wheat germ 2.4x
                                Wheat bran 2.7x
                                   47567115
1.5 (Tol)
0.22 (AR)
Water
N/A
Modeling
                                      N/A
                                      N/A
                                      N/A
                                      N/A
                                      N/A
0.013
0.0049 (0.0035 for cancer)
For risk assessment in livestock commodities, metabolites 7-hydroxy and the 2 olefins need to be included; and in poultry commodities, the 2 olefin metabolites need to be included.  Based on the goat metabolism data (phenyl label), the ratios of the sum of parent, benzamide, 7-hydroxy, and the olefins to the sum of parent and benzamide are 1.02 in milk, 1.00 in meat, 1.43 in fat, 1.02 in liver, and 1.01 in kidney.  Therefore, for fat commodities in the acute assessment, an adjustment factor of 1.43 has been applied.  
Based on the poultry metabolism data (phenyl label), the ratios of the sum of parent, benzamide, and the olefins to the sum of parent and benzamide are 1.01 in egg, 1.01 in meat, 1.39 in fat, and 1.01 in liver.  Therefore, for fat commodities in the acute assessment, an adjustment factor of 1.39 has been applied.
See charts below for residue estimates for chronic dietary assessment.
Meat (except pork)


                                       
                                       
                                       
                                       
                                       
0.15 (Tol)
0.0007 (AR)
Meat byproducts (except pork)


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


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


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


                                       
                                       
                                       
                                       
                                       
1.1 (Tol)
0.0069 (AR)
Chicken meat


                                       
                                       
                                       
                                       
                                       
0.15 (Tol)
0.014 (AR)
Chicken liver


                                       
                                       
                                       
                                       
                                       
0.60 (Tol)
0.022 (AR)
Chicken meat byproducts


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


                                       
                                       
                                       
                                       
                                       
0.20 (Tol)
0.014 (AR)
Egg


                                       
                                       
                                       
                                       
                                       
0.25 (Tol)
0.014 (AR)
Milk


                                       
                                       
                                       
                                       
                                       
0.07 (Tol)
0.0029 (AR)
Pork meat


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


                                       
                                       
                                       
                                       
                                       
0.05 (Tol)
0.0005 (AR)
Pork kidney


                                       
                                       
                                       
                                       
                                       
0.70 (Tol)
0.0015 (AR)
Pork liver


                                       
                                       
                                       
                                       
                                       
0.70 (Tol)
0.009 (AR)

N/A =  not applicable
1.  	Classification of blended (B), partially blended (PB), not blended (NB).
2.	HR=highest residue; HAFT=highest average field trial value; AR=average residue



Cattle feeding study maximum residues in ppm parent equivalents at 1.5 ppm feeding level: 
Dairy
                                     Milk
                                      Fat
                                     Liver
                                    Muscle
                                    Kidney
fluopyram
                                     0.01
                                   <0.01
                                     0.25
                                   <0.01
                                   <0.01
benzamide
                                     0.02
                                   <0.01
                                     0.10
                                     0.02
                                     0.03
7-OH 
                            <<0.01/<0.003
                                 <<0.01
                                     0.006
                                 <<0.01
                                     0.003
Olefins (2)
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                     0.02
Total
                                     0.04
                                     0.02
                                     0.37
                                     0.04
                                     0.06
0.11/1.5
                                    0.0029
                                       
                                       
                                       
                                       
LOQ = 0.01 ppm parent, benzamide, 7-hydroxy; 0.02 ppm olefins (E & Z isomers)



Beef
                                     Milk
                                      Fat
                                     Liver
                                    Muscle
                                    Kidney
fluopyram
                                     0.01
                                   <0.01
                                     0.25
                                   <0.01
                                   <0.01
benzamide
                                     0.02
                                   <0.01
                                     0.10
                                     0.02
                                     0.03
7-OH 
                                 <<0.01
                                 <<0.01
                                     0.006
                                 <<0.01
                                     0.003
Olefins (2)
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                     0.02
Total
                                     0.04
                                     0.02
                                     0.37
                                     0.04
                                     0.06
0.028/1.5
                                       
                                    0.0004
                                    0.0069
                                    0.0007
                                    0.0011
0.038/1.5 (hog)
                                       
                                    0.0005
                                     0.009
                                     0.001
                                    0.0015


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

                                      Egg
                                 Skin with fat
                                     Liver
                                    Muscle
                                       
fluopyram
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                       
benzamide
                                   <0.01
                                   <0.01
                                     0.02
                                   <0.01
                                       
Olefins (2)
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                       
Total
                                     0.02
                                     0.02
                                     0.03
                                     0.02
                                       
0.036/0.05 (0.72x)
                                     0.014
                                     0.014
                                     0.022
                                     0.014
                                       


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 Matter[2]
                                   % Diet[2]
                             Average Residue (ppm)
                                   PPCT [3]
                         Dietary Contribution (ppm)[4]
Beef Cattle: 15% R, 80% CC, 5% PC
Corn, field, forage/silage
                                       R
                                      40
                                      15
                                     1.76
                                       1
                                    0.0066
Sorghum, grain, grain
                                      CC
                                      86
                                      40
                                     0.31
                                      12
                                    0.0173
Wheat, milled byproducts
                                      CC
                                      88
                                      30
                                     0.30
                                       1
                                     0.001
Beet, sugar, molasses
                                      CC
                                      75
                                      10
                                     0.021
                                      48
                                    0.0013
Canola, meal
                                      PC
                                      88
                                       5
                                     0.075
                                      73
                                    0.0031
TOTAL BURDEN
                                      --
                                      --
                                      100
                                      --
                                      --
                                     0.028
Dairy Cattle: 45% R, 45% CC, 10% PC
Almond, hulls
                                       R
                                      90
                                       5
                                     3.08
                                      43
                                    0.0736
Corn, sweet, forage/silage
                                       R
                                      48
                                      40
                                     1.76
                                       1
                                    0.0147
Sorghum, grain, grain
                                      CC
                                      86
                                      35
                                     0.31
                                      12
                                    0.0151
Beet, sugar, molasses
                                      CC
                                      75
                                      10
                                     0.021
                                      48
                                    0.0013
Canola, meal
                                      PC
                                      88
                                      10
                                     0.075
                                      73
                                    0.0062
TOTAL BURDEN
                                      --
                                      --
                                      100
                                      --
                                      --
                                     0.11
Poultry: 75% CC, 25% PC
Sorghum, grain, grain
                                      CC
                                      86
                                      75
                                     0.31
                                      12
                                    0.0279
Canola, meal
                                      PC
                                      88
                                      15
                                     0.075
                                      73
                                    0.0082
Alfalfa, meal
                                      PC
                                      89
                                       5
                                     0.16
                                       4
                                    0.0003
Untreated
                                      PC
                                      --
                                       5
                                      --
                                      --
                                       
TOTAL BURDEN
                                      --
                                      --
                                      100
                                      --
                                      --
                                     0.036
Swine: 85% CC, 15% PC
Sorghum, grain, grain
                                      CC
                                      86
                                      80
                                     0.31
                                      12
                                    0.0298
Wheat, milled byproducts
                                      CC
                                      88
                                       5
                                     0.30
                                       1
                                    0.0002
Canola, meal
                                      PC
                                      88
                                      15
                                     0.075
                                      73
                                    0.0082
TOTAL BURDEN
                                      --
                                      --
                                      100
                                      --
                                      --
                                     0.038
[1]  R:  Roughage; CC:  Carbohydrate concentrate; PC:  Protein concentrate.
[2]  OPPTS 860.1000 Table 1 Feedstuffs (June 2008).  
[3]  Projected percent crop treated values from BEAD.  
[4]  Contribution = ([residue /% DM] X % diet) for beef and dairy cattle; contribution = ([residue] X % diet) for poultry and swine. 


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

U.S. Environmental Protection Agency                                 Ver. 2.02
DEEM-FCID Acute analysis for FLUOPYRAM
Residue file name: C:\Documents and Settings\lcheng\My Documents\DEEM FCID lc\Fluopyram\Tolerance 2011-08-08.R98
Analysis Date 09-23-2011             Residue file dated: 09-23-2011/14:56:51/8
Reference dose (aRfD) = 0.5 mg/kg bw/day
Comment: Tolerance residues 2011-08-08 crops 13 ppb water
--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code    Grp  Food Name                         (ppm)       #1    #2   
-------- ---- -------------------------------  ----------  ------ ------  -------
14000030 14   Almond                             0.050000   1.000  1.000
14000031 14   Almond-babyfood                    0.050000   1.000  1.000
14000040 14   Almond, oil                        0.050000   1.000  1.000
14000041 14   Almond, oil-babyfood               0.050000   1.000  1.000
11000070 11   Apple, fruit with peel             0.300000   1.000  1.000
11000080 11   Apple, peeled fruit                0.300000   1.000  1.000
11000081 11   Apple, peeled fruit-babyfood       0.300000   1.000  1.000
11000090 11   Apple, dried                       0.300000   1.000  1.000
11000091 11   Apple, dried-babyfood              0.300000   1.000  1.000
11000100 11   Apple, juice                       0.300000   1.000  1.000
11000101 11   Apple, juice-babyfood              0.300000   1.000  1.000
11000110 11   Apple, sauce                       0.300000   1.000  1.000
11000111 11   Apple, sauce-babyfood              0.300000   1.000  1.000
95000230 O    Banana                             1.000000   1.000  1.000
95000231 O    Banana-babyfood                    1.000000   3.900  1.000
95000240 O    Banana, dried                      1.000000   3.900  1.000
95000241 O    Banana, dried-babyfood             1.000000   1.000  1.000
15000250 15   Barley, pearled barley             1.500000   1.000  1.000
15000251 15   Barley, pearled barley-babyfood    1.500000   1.000  1.000
15000260 15   Barley, flour                      1.500000   1.000  1.000
15000261 15   Barley, flour-babyfood             1.500000   1.000  1.000
15000270 15   Barley, bran                       1.500000   2.700  1.000
06030300 6C   Bean, black, seed                  0.090000   6.100  1.000
06030320 6C   Bean, broad, seed                  0.090000   6.100  1.000
06030340 6C   Bean, cowpea, seed                 0.090000   6.100  1.000
06030350 6C   Bean,  great northern, seed        0.090000   6.100  1.000
06030360 6C   Bean, kidney, seed                 0.090000   6.100  1.000
06030380 6C   Bean, lima, seed                   0.090000   6.100  1.000
06030390 6C   Bean, mung, seed                   0.090000   6.100  1.000
06030400 6C   Bean, navy, seed                   0.090000   6.100  1.000
06030410 6C   Bean, pink, seed                   0.090000   6.100  1.000
06030420 6C   Bean, pinto, seed                  0.090000   6.100  1.000
21000440 M    Beef, meat                         0.150000   1.000  1.000
21000441 M    Beef, meat-babyfood                0.150000   1.000  1.000
21000450 M    Beef, meat, dried                  0.150000   1.920  1.000
21000460 M    Beef, meat byproducts              1.100000   1.000  1.000
21000461 M    Beef, meat byproducts-babyfood     1.100000   1.000  1.000
21000470 M    Beef, fat                          0.110000   1.430  1.000
21000471 M    Beef,fat-babyfood                  0.110000   1.430  1.000
21000480 M    Beef, kidney                       1.100000   1.000  1.000
21000490 M    Beef, liver                        1.100000   1.000  1.000
21000491 M    Beef, liver-babyfood               1.100000   1.000  1.000
01010520 1A   Beet, sugar                        0.040000   1.300  1.000
01010521 1A   Beet, sugar-babyfood               0.040000   1.300  1.000
01010530 1A   Beet, sugar, molasses              0.040000   1.000  1.000
01010531 1A   Beet, sugar, molasses-babyfood     0.040000   1.000  1.000
14000590 14   Brazil nut                         0.050000   1.000  1.000
15000650 15   Buckwheat                          1.500000   1.000  1.000
15000660 15   Buckwheat, flour                   1.500000   1.000  1.000
14000680 14   Butternut                          0.050000   1.000  1.000
14000810 14   Cashew                             0.050000   1.000  1.000
12000900 12   Cherry                             0.600000   1.000  1.000
12000901 12   Cherry-babyfood                    0.600000   1.000  1.000
12000910 12   Cherry, juice                      0.600000   1.000  1.000
12000911 12   Cherry, juice-babyfood             0.600000   1.000  1.000
14000920 14   Chestnut                           0.050000   1.000  1.000
40000930 P    Chicken, meat                      0.150000   1.000  1.000
40000931 P    Chicken, meat-babyfood             0.150000   1.000  1.000
40000940 P    Chicken, liver                     0.600000   1.000  1.000
40000950 P    Chicken, meat byproducts           0.600000   1.000  1.000
40000951 P    Chicken, meat byproducts-babyfoo   0.600000   1.000  1.000
40000960 P    Chicken, fat                       0.200000   1.390  1.000
40000961 P    Chicken, fat-babyfood              0.200000   1.390  1.000
40000970 P    Chicken, skin                      0.200000   1.390  1.000
40000971 P    Chicken, skin-babyfood             0.200000   1.390  1.000
06030980 6C   Chickpea, seed                     0.090000   6.100  1.000
06030981 6C   Chickpea, seed-babyfood            0.090000   6.100  1.000
06030990 6C   Chickpea, flour                    0.090000   6.100  1.000
15001200 15   Corn, field, flour                 1.500000   1.000  1.000
15001201 15   Corn, field, flour-babyfood        1.500000   1.000  1.000
15001210 15   Corn, field, meal                  1.500000   1.000  1.000
15001211 15   Corn, field, meal-babyfood         1.500000   1.000  1.000
15001220 15   Corn, field, bran                  1.500000   2.600  1.000
15001230 15   Corn, field, starch                1.500000   1.000  1.000
15001231 15   Corn, field, starch-babyfood       1.500000   1.000  1.000
15001240 15   Corn, field, syrup                 1.500000   1.000  1.000
15001241 15   Corn, field, syrup-babyfood        1.500000   1.000  1.000
15001250 15   Corn, field, oil                   1.500000   1.000  1.000
15001251 15   Corn, field, oil-babyfood          1.500000   1.000  1.000
15001260 15   Corn, pop                          1.500000   1.000  1.000
15001270 15   Corn, sweet                        1.500000   1.000  1.000
15001271 15   Corn, sweet-babyfood               1.500000   1.000  1.000
95001280 O    Cottonseed, oil                    0.010000   1.500  1.000
95001281 O    Cottonseed, oil-babyfood           0.010000   1.500  1.000
70001450 P    Egg, whole                         0.250000   1.000  1.000
70001451 P    Egg, whole-babyfood                0.250000   1.000  1.000
70001460 P    Egg, white                         0.250000   1.000  1.000
70001461 P    Egg, white (solids)-babyfood       0.250000   1.000  1.000
70001470 P    Egg, yolk                          0.250000   1.000  1.000
70001471 P    Egg, yolk-babyfood                 0.250000   1.000  1.000
14001550 14   Filbert                            0.050000   1.000  1.000
14001560 14   Filbert, oil                       0.050000   1.000  1.000
23001690 M    Goat, meat                         0.150000   1.000  1.000
23001700 M    Goat, meat byproducts              1.100000   1.000  1.000
23001710 M    Goat, fat                          0.110000   1.430  1.000
23001720 M    Goat, kidney                       1.100000   1.000  1.000
23001730 M    Goat, liver                        1.100000   1.000  1.000
95001790 O    Grape, wine and sherry             2.000000   1.000  1.000
06031820 6C   Guar, seed                         0.090000   6.100  1.000
06031821 6C   Guar, seed-babyfood                0.090000   6.100  1.000
14001850 14   Hickory nut                        0.050000   1.000  1.000
24001890 M    Horse, meat                        0.150000   1.000  1.000
06032030 6C   Lentil, seed                       0.090000   6.100  1.000
14002130 14   Macadamia nut                      0.050000   1.000  1.000
28002210 M    Meat, game                         0.150000   1.000  1.000
27002220 D    Milk, fat                          0.070000   1.000  1.000
27002221 D    Milk, fat - baby food/infant for   0.070000   1.000  1.000
27012230 D    Milk, nonfat solids                0.070000   1.000  1.000
27012231 D    Milk, nonfat solids-baby food/in   0.070000   1.000  1.000
27022240 D    Milk, water                        0.070000   1.000  1.000
27022241 D    Milk, water-babyfood/infant form   0.070000   1.000  1.000
27032251 D    Milk, sugar (lactose)-baby food/   0.070000   1.000  1.000
15002260 15   Millet, grain                      1.500000   1.000  1.000
15002310 15   Oat, bran                          1.500000   2.700  1.000
15002320 15   Oat, flour                         1.500000   1.000  1.000
15002321 15   Oat, flour-babyfood                1.500000   1.000  1.000
15002330 15   Oat, groats/rolled oats            1.500000   1.000  1.000
15002331 15   Oat, groats/rolled oats-babyfood   1.500000   1.000  1.000
95002630 O    Peanut                             0.020000   1.000  1.000
95002640 O    Peanut, butter                     0.020000   1.000  1.000
95002650 O    Peanut, oil                        0.020000   1.000  1.000
14002690 14   Pecan                              0.050000   1.000  1.000
14002820 14   Pistachio                          0.050000   1.000  1.000
25002900 M    Pork, meat                         0.050000   1.000  1.000
25002901 M    Pork, meat-babyfood                0.050000   1.000  1.000
25002910 M    Pork, skin                         0.050000   1.000  1.000
25002920 M    Pork, meat byproducts              0.700000   1.000  1.000
25002921 M    Pork, meat byproducts-babyfood     0.700000   1.000  1.000
25002930 M    Pork, fat                          0.050000   1.430  1.000
25002931 M    Pork, fat-babyfood                 0.050000   1.430  1.000
25002940 M    Pork, kidney                       0.700000   1.000  1.000
25002950 M    Pork, liver                        0.700000   1.000  1.000
01032960 1C   Potato, chips                      0.020000   1.000  1.000
01032970 1C   Potato, dry (granules/ flakes)     0.020000   1.000  1.000
01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   1.000  1.000
01032980 1C   Potato, flour                      0.020000   1.000  1.000
01032981 1C   Potato, flour-babyfood             0.020000   1.000  1.000
01032990 1C   Potato, tuber, w/peel              0.020000   1.000  1.000
01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000
01033000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000
01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000
60003010 P    Poultry, other, meat               0.150000   1.000  1.000
60003020 P    Poultry, other, liver              0.600000   1.000  1.000
60003030 P    Poultry, other, meat byproducts    0.600000   1.000  1.000
60003040 P    Poultry, other, fat                0.200000   1.390  1.000
60003050 P    Poultry, other, skin               0.200000   1.390  1.000
29003120 M    Rabbit, meat                       0.150000   1.000  1.000
20003190 20   Rapeseed, oil                      1.800000   1.500  1.000
20003191 20   Rapeseed, oil-babyfood             1.800000   1.500  1.000
15003280 15   Rye, grain                         1.500000   1.000  1.000
15003290 15   Rye, flour                         1.500000   1.000  1.000
26003390 M    Sheep, meat                        0.150000   1.000  1.000
26003391 M    Sheep, meat-babyfood               0.150000   1.000  1.000
26003400 M    Sheep, meat byproducts             1.100000   1.000  1.000
26003410 M    Sheep, fat                         0.110000   1.430  1.000
26003411 M    Sheep, fat-babyfood                0.110000   1.430  1.000
26003420 M    Sheep, kidney                      1.100000   1.000  1.000
26003430 M    Sheep, liver                       1.100000   1.000  1.000
15003440 15   Sorghum, grain                     1.500000   1.000  1.000
15003450 15   Sorghum, syrup                     1.500000   1.000  1.000
06003470 6    Soybean, seed                      0.100000   1.000  1.000
06003480 6    Soybean, flour                     0.100000   1.000  1.000
06003481 6    Soybean, flour-babyfood            0.100000   1.000  1.000
06003490 6    Soybean, soy milk                  0.100000   1.000  1.000
06003491 6    Soybean, soy milk-babyfood or in   0.100000   1.000  1.000
06003500 6    Soybean, oil                       0.100000   1.000  1.000
06003501 6    Soybean, oil-babyfood              0.100000   1.000  1.000
95003590 O    Strawberry                         1.500000   1.000  1.000
95003591 O    Strawberry-babyfood                1.500000   1.000  1.000
95003600 O    Strawberry, juice                  1.500000   1.000  1.000
95003601 O    Strawberry, juice-babyfood         1.500000   1.000  1.000
15003810 15   Triticale, flour                   1.500000   1.000  1.000
15003811 15   Triticale, flour-babyfood          1.500000   1.000  1.000
50003820 P    Turkey, meat                       0.150000   1.000  1.000
50003821 P    Turkey, meat-babyfood              0.150000   1.000  1.000
50003830 P    Turkey, liver                      0.600000   1.000  1.000
50003831 P    Turkey, liver-babyfood             0.600000   1.000  1.000
50003840 P    Turkey, meat byproducts            0.600000   1.000  1.000
50003841 P    Turkey, meat byproducts-babyfood   0.600000   1.000  1.000
50003850 P    Turkey, fat                        0.200000   1.390  1.000
50003851 P    Turkey, fat-babyfood               0.200000   1.390  1.000
50003860 P    Turkey, skin                       0.200000   1.390  1.000
50003861 P    Turkey, skin-babyfood              0.200000   1.390  1.000
14003910 14   Walnut                             0.050000   1.000  1.000
86010000 O    Water, direct, all sources         0.013000   1.000  1.000
86020000 O    Water, indirect, all sources       0.013000   1.000  1.000
09013990 9A   Watermelon                         1.000000   1.000  1.000
09014000 9A   Watermelon, juice                  1.000000   1.000  1.000
15004010 15   Wheat, grain                       1.500000   1.000  1.000
15004011 15   Wheat, grain-babyfood              1.500000   1.000  1.000
15004020 15   Wheat, flour                       1.500000   1.000  1.000
15004021 15   Wheat, flour-babyfood              1.500000   1.000  1.000
15004030 15   Wheat, germ                        1.500000   2.400  1.000
15004040 15   Wheat, bran                        1.500000   2.700  1.000

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


U.S. Environmental Protection Agency                                  Ver. 2.02
DEEM-FCID ACUTE Analysis for FLUOPYRAM                           (1994-98 data)
Residue file: Tolerance 2011-08-08.R98            Adjustment factor #2 NOT used.
Analysis Date: 09-23-2011/15:04:41    Residue file dated: 09-23-2011/14:56:51/8
Daily totals for food and foodform consumption used.
Run Comment: "Tolerance residues 2011-08-08 crops 13 ppb water"
===============================================================================

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile
                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD 
                  ---------- --------  ---------- --------  ---------- --------
U.S. Population:
                    0.020741     4.15    0.033456     6.69    0.054800    10.96 
All infants:
                    0.038195     7.64    0.063671    12.73    0.112337    22.47 
Children 1-2 yrs:
                    0.042156     8.43    0.054792    10.96    0.078116    15.62 
Children 3-5 yrs:
                    0.035136     7.03    0.047878     9.58    0.073838    14.77 
Children 6-12 yrs:
                    0.024081     4.82    0.035065     7.01    0.054834    10.97 
Youth 13-19 yrs:
                    0.015398     3.08    0.024207     4.84    0.037645     7.53 
Adults 20-49 yrs:
                    0.013032     2.61    0.019434     3.89    0.032439     6.49 
Adults 50+ yrs:
                    0.011141     2.23    0.017676     3.54    0.031026     6.21 
Females 13-49 yrs:
                    0.012844     2.57    0.019692     3.94    0.032515     6.50 

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

U.S. Environmental Protection Agency                                 Ver. 2.00
DEEM-FCID Chronic analysis for FLUOPYRAM                          1994-98 data
Residue file: C:\Documents and Settings\lcheng\My Documents\DEEM FCID lc\Fluopyram\chronic AR 2011-08-08 water.R98
                                                           Adjust. #2 NOT used
Analysis Date 09-23-2011             Residue file dated: 09-23-2011/14:39:42/8
Reference dose (RfD) = 0.012 mg/kg bw/day
Comment:chronic assess 2011-08-08 crops 5 ppb water
--------------------------------------------------------------------------------
Food Crop                                       Residue       Adj.Factors      Comment
EPA Code  Grp  Food Name                          (ppm)       
                                                             #1         #2 
-------- ---- -------------------------------   ---------- ------     ------   -------
14000030 14   Almond                             0.010000   1.000      0.330   
14000031 14   Almond-babyfood                    0.010000   1.000      0.330   
14000040 14   Almond, oil                        0.010000   1.000      0.330   
14000041 14   Almond, oil-babyfood               0.010000   1.000      0.330   
11000070 11   Apple, fruit with peel             0.110000   0.700      0.400   
11000080 11   Apple, peeled fruit                0.110000   0.030      0.400   
11000081 11   Apple, peeled fruit-babyfood       0.110000   0.030      0.400   
11000090 11   Apple, dried                       0.110000   0.030      0.400   
11000091 11   Apple, dried-babyfood              0.110000   0.030      0.400   
11000100 11   Apple, juice                       0.110000   0.400      0.400   
11000101 11   Apple, juice-babyfood              0.110000   0.400      0.400   
11000110 11   Apple, sauce                       0.110000   0.010      0.400   
11000111 11   Apple, sauce-babyfood              0.110000   0.010      0.400   
95000230 O    Banana                             0.020000   1.000      1.000   
95000231 O    Banana-babyfood                    0.020000   1.000      1.000   
95000240 O    Banana, dried                      0.020000   3.900      1.000   
95000241 O    Banana, dried-babyfood             0.020000   3.900      1.000   
15000250 15   Barley, pearled barley             0.220000   1.000      0.220   
15000251 15   Barley, pearled barley-babyfood    0.220000   1.000      0.220   
15000260 15   Barley, flour                      0.220000   0.120      0.220   
15000261 15   Barley, flour-babyfood             0.220000   0.120      0.220   
15000270 15   Barley, bran                       0.220000   2.700      0.220   
06030300 6C   Bean, black, seed                  0.010000   6.100      0.070   
06030320 6C   Bean, broad, seed                  0.010000   6.100      0.070   
06030340 6C   Bean, cowpea, seed                 0.010000   6.100      0.070   
06030350 6C   Bean,  great northern, seed        0.010000   6.100      0.070   
06030360 6C   Bean, kidney, seed                 0.010000   6.100      0.070   
06030380 6C   Bean, lima, seed                   0.010000   6.100      0.070   
06030390 6C   Bean, mung, seed                   0.010000   6.100      0.070   
06030400 6C   Bean, navy, seed                   0.010000   6.100      0.070   
06030410 6C   Bean, pink, seed                   0.010000   6.100      0.070   
06030420 6C   Bean, pinto, seed                  0.010000   6.100      0.070   
21000440 M    Beef, meat                         0.000700   1.000      1.000   
21000441 M    Beef, meat-babyfood                0.000700   1.000      1.000   
21000450 M    Beef, meat, dried                  0.000700   1.920      1.000   
21000460 M    Beef, meat byproducts              0.001100   1.000      1.000   
21000461 M    Beef, meat byproducts-babyfood     0.001100   1.000      1.000   
21000470 M    Beef, fat                          0.000400   1.000      1.000   
21000471 M    Beef,fat-babyfood                  0.000400   1.000      1.000   
21000480 M    Beef, kidney                       0.001100   1.000      1.000   
21000490 M    Beef, liver                        0.006900   1.000      1.000   
21000491 M    Beef, liver-babyfood               0.006900   1.000      1.000   
01010520 1A   Beet, sugar                        0.010000   1.300      0.480   
01010521 1A   Beet, sugar-babyfood               0.010000   1.300      0.480   
01010530 1A   Beet, sugar, molasses              0.010000   0.900      0.480   
01010531 1A   Beet, sugar, molasses-babyfood     0.010000   0.900      0.480   
14000590 14   Brazil nut                         0.010000   1.000      1.000   
15000650 15   Buckwheat                          0.220000   1.000      1.000   
15000660 15   Buckwheat, flour                   0.220000   0.120      1.000   
14000680 14   Butternut                          0.010000   1.000      1.000   
14000810 14   Cashew                             0.010000   1.000      1.000   
12000900 12   Cherry                             0.190000   1.000      0.490   
12000901 12   Cherry-babyfood                    0.190000   1.000      0.490   
12000910 12   Cherry, juice                      0.190000   1.000      0.490   
12000911 12   Cherry, juice-babyfood             0.190000   1.000      0.490   
14000920 14   Chestnut                           0.010000   1.000      1.000   
40000930 P    Chicken, meat                      0.014000   1.000      1.000   
40000931 P    Chicken, meat-babyfood             0.014000   1.000      1.000   
40000940 P    Chicken, liver                     0.022000   1.000      1.000   
40000950 P    Chicken, meat byproducts           0.014000   1.000      1.000   
40000951 P    Chicken, meat byproducts-babyfoo   0.014000   1.000      1.000   
40000960 P    Chicken, fat                       0.014000   1.000      1.000   
40000961 P    Chicken, fat-babyfood              0.014000   1.000      1.000   
40000970 P    Chicken, skin                      0.014000   1.000      1.000   
40000971 P    Chicken, skin-babyfood             0.014000   1.000      1.000   
06030980 6C   Chickpea, seed                     0.010000   6.100      0.070   
06030981 6C   Chickpea, seed-babyfood            0.010000   6.100      0.070   
06030990 6C   Chickpea, flour                    0.010000   6.100      0.070   
15001200 15   Corn, field, flour                 0.010000   0.850      0.010   
15001201 15   Corn, field, flour-babyfood        0.010000   0.850      0.010   
15001210 15   Corn, field, meal                  0.010000   0.800      0.010   
15001211 15   Corn, field, meal-babyfood         0.010000   0.800      0.010   
15001220 15   Corn, field, bran                  0.010000   2.640      0.010   
15001230 15   Corn, field, starch                0.010000   0.150      0.010   
15001231 15   Corn, field, starch-babyfood       0.010000   0.150      0.010   
15001240 15   Corn, field, syrup                 0.010000   1.000      0.010   
15001241 15   Corn, field, syrup-babyfood        0.010000   1.000      0.010   
15001250 15   Corn, field, oil                   0.010000   0.350      0.010   
15001251 15   Corn, field, oil-babyfood          0.010000   0.350      0.010   
15001260 15   Corn, pop                          0.010000   1.000      0.010   
15001270 15   Corn, sweet                        0.005000   1.000      0.010   
15001271 15   Corn, sweet-babyfood               0.005000   1.000      0.010   
95001280 O    Cottonseed, oil                    0.010000   0.015      0.070   
95001281 O    Cottonseed, oil-babyfood           0.010000   0.015      0.070   
70001450 P    Egg, whole                         0.014000   1.000      1.000   
70001451 P    Egg, whole-babyfood                0.014000   1.000      1.000   
70001460 P    Egg, white                         0.014000   1.000      1.000   
70001461 P    Egg, white (solids)-babyfood       0.014000   1.000      1.000   
70001470 P    Egg, yolk                          0.014000   1.000      1.000   
70001471 P    Egg, yolk-babyfood                 0.014000   1.000      1.000   
14001550 14   Filbert                            0.010000   1.000      1.000   
14001560 14   Filbert, oil                       0.010000   1.000      1.000   
23001690 M    Goat, meat                         0.000700   1.000      1.000   
23001700 M    Goat, meat byproducts              0.001100   1.000      1.000   
23001710 M    Goat, fat                          0.000400   1.000      1.000   
23001720 M    Goat, kidney                       0.001100   1.000      1.000   
23001730 M    Goat, liver                        0.006900   1.000      1.000   
95001790 O    Grape, wine and sherry             0.400000   0.500      0.790   
06031820 6C   Guar, seed                         0.010000   6.100      0.070   
06031821 6C   Guar, seed-babyfood                0.010000   6.100      0.070   
14001850 14   Hickory nut                        0.010000   1.000      1.000   
24001890 M    Horse, meat                        0.000700   1.000      1.000   
06032030 6C   Lentil, seed                       0.010000   6.100      0.070   
14002130 14   Macadamia nut                      0.010000   1.000      1.000   
28002210 M    Meat, game                         0.000700   1.000      1.000   
27002220 D    Milk, fat                          0.002900   1.000      1.000   
27002221 D    Milk, fat - baby food/infant for   0.002900   1.000      1.000   
27012230 D    Milk, nonfat solids                0.002900   1.000      1.000   
27012231 D    Milk, nonfat solids-baby food/in   0.002900   1.000      1.000   
27022240 D    Milk, water                        0.002900   1.000      1.000   
27022241 D    Milk, water-babyfood/infant form   0.002900   1.000      1.000   
27032251 D    Milk, sugar (lactose)-baby food/   0.002900   1.000      1.000   
15002260 15   Millet, grain                      0.620000   1.000      1.000   
15002310 15   Oat, bran                          0.220000   1.000      0.230   
15002320 15   Oat, flour                         0.220000   1.000      0.230   
15002321 15   Oat, flour-babyfood                0.220000   1.000      0.230   
15002330 15   Oat, groats/rolled oats            0.220000   1.000      0.230   
15002331 15   Oat, groats/rolled oats-babyfood   0.220000   1.000      0.230   
95002630 O    Peanut                             0.011000   1.000      0.670   
95002640 O    Peanut, butter                     0.011000   0.220      0.670   
95002650 O    Peanut, oil                        0.011000   0.260      0.670   
14002690 14   Pecan                              0.010000   1.000      1.000   
14002820 14   Pistachio                          0.010000   1.000      1.000   
25002900 M    Pork, meat                         0.001000   1.000      1.000   
25002901 M    Pork, meat-babyfood                0.001000   1.000      1.000   
25002910 M    Pork, skin                         0.000500   1.000      1.000   
25002920 M    Pork, meat byproducts              0.001500   1.000      1.000   
25002921 M    Pork, meat byproducts-babyfood     0.001500   1.000      1.000   
25002930 M    Pork, fat                          0.000500   1.000      1.000   
25002931 M    Pork, fat-babyfood                 0.000500   1.000      1.000   
25002940 M    Pork, kidney                       0.001500   1.000      1.000   
25002950 M    Pork, liver                        0.009000   1.000      1.000   
01032960 1C   Potato, chips                      0.010000   0.300      0.640   
01032970 1C   Potato, dry (granules/ flakes)     0.010000   1.000      0.640   
01032971 1C   Potato, dry (granules/ flakes)-b   0.010000   1.000      0.640   
01032980 1C   Potato, flour                      0.010000   1.000      0.640   
01032981 1C   Potato, flour-babyfood             0.010000   1.000      0.640   
01032990 1C   Potato, tuber, w/peel              0.010000   1.000      0.640   
01032991 1C   Potato, tuber, w/peel-babyfood     0.010000   1.000      0.640   
01033000 1C   Potato, tuber, w/o peel            0.010000   0.200      0.640   
01033001 1C   Potato, tuber, w/o peel-babyfood   0.010000   0.200      0.640   
60003010 P    Poultry, other, meat               0.014000   1.000      1.000   
60003020 P    Poultry, other, liver              0.022000   1.000      1.000   
60003030 P    Poultry, other, meat byproducts    0.014000   1.000      1.000   
60003040 P    Poultry, other, fat                0.014000   1.000      1.000   
60003050 P    Poultry, other, skin               0.014000   1.000      1.000   
29003120 M    Rabbit, meat                       0.014000   1.000      1.000   
20003190 20   Rapeseed, oil                      0.510000   0.015      0.730   
20003191 20   Rapeseed, oil-babyfood             0.510000   0.015      0.730   
15003280 15   Rye, grain                         0.220000   1.000      0.630   
15003290 15   Rye, flour                         0.220000   1.000      0.630   
26003390 M    Sheep, meat                        0.000700   1.000      1.000   
26003391 M    Sheep, meat-babyfood               0.000700   1.000      1.000   
26003400 M    Sheep, meat byproducts             0.001100   1.000      1.000   
26003410 M    Sheep, fat                         0.000400   1.000      1.000   
26003411 M    Sheep, fat-babyfood                0.000400   1.000      1.000   
26003420 M    Sheep, kidney                      0.001100   1.000      1.000   
26003430 M    Sheep, liver                       0.006900   1.000      1.000   
15003440 15   Sorghum, grain                     0.620000   1.000      0.120   
15003450 15   Sorghum, syrup                     0.620000   1.000      0.120   
06003470 6    Soybean, seed                      0.024000   1.000      0.010   
06003480 6    Soybean, flour                     0.024000   0.040      0.010   
06003481 6    Soybean, flour-babyfood            0.024000   0.040      0.010   
06003490 6    Soybean, soy milk                  0.024000   0.010      0.010   
06003491 6    Soybean, soy milk-babyfood or in   0.024000   0.010      0.010   
06003500 6    Soybean, oil                       0.024000   0.020      0.010   
06003501 6    Soybean, oil-babyfood              0.024000   0.020      0.010   
95003590 O    Strawberry                         0.190000   1.000      0.710   
95003591 O    Strawberry-babyfood                0.190000   1.000      0.710   
95003600 O    Strawberry, juice                  0.190000   1.000      0.710   
95003601 O    Strawberry, juice-babyfood         0.190000   1.000      0.710   
15003810 15   Triticale, flour                   0.220000   1.000      1.000   
15003811 15   Triticale, flour-babyfood          0.220000   1.000      1.000   
50003820 P    Turkey, meat                       0.014000   1.000      1.000   
50003821 P    Turkey, meat-babyfood              0.014000   1.000      1.000   
50003830 P    Turkey, liver                      0.022000   1.000      1.000   
50003831 P    Turkey, liver-babyfood             0.022000   1.000      1.000   
50003840 P    Turkey, meat byproducts            0.014000   1.000      1.000   
50003841 P    Turkey, meat byproducts-babyfood   0.014000   1.000      1.000   
50003850 P    Turkey, fat                        0.014000   1.000      1.000   
50003851 P    Turkey, fat-babyfood               0.014000   1.000      1.000   
50003860 P    Turkey, skin                       0.014000   1.000      1.000   
50003861 P    Turkey, skin-babyfood              0.014000   1.000      1.000   
14003910 14   Walnut                             0.010000   1.000      1.000   
86010000 O    Water, direct, all sources         0.004900   1.000      1.000   
86020000 O    Water, indirect, all sources       0.004900   1.000      1.000   
09013990 9A   Watermelon                         0.220000   1.000      0.540   
09014000 9A   Watermelon, juice                  0.220000   1.000      0.540   
15004010 15   Wheat, grain                       0.220000   1.000      0.010   
15004011 15   Wheat, grain-babyfood              0.220000   1.000      0.010   
15004020 15   Wheat, flour                       0.220000   0.120      0.010   
15004021 15   Wheat, flour-babyfood              0.220000   0.120      0.010   
15004030 15   Wheat, germ                        0.220000   2.400      0.010   
15004040 15   Wheat, bran                        0.220000   2.700      0.010   

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

U.S. Environmental Protection Agency                                 Ver. 2.00
DEEM-FCID Chronic analysis for FLUOPYRAM                        (1994-98 data)
Residue file name: C:\Documents and Settings\lcheng\My Documents\DEEM FCID lc\Fluopyram\chronic AR 2011-08-08 water.R98
                                                 Adjustment factor #2 NOT used.
Analysis Date 09-23-2011/15:27:51     Residue file dated: 09-23-2011/14:39:42/8
Reference dose (RfD, Chronic) = .012 mg/kg bw/day
COMMENT 1: chronic assess 2011-08-08 crops 5 ppb water
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ---------------
U.S. Population (total)                     0.000423                 3.5%

U.S. Population (spring season)             0.000443                 3.7%
U.S. Population (summer season)             0.000453                 3.8%
U.S. Population (autumn season)             0.000400                 3.3%
U.S. Population (winter season)             0.000395                 3.3%

Northeast region                            0.000436                 3.6%
Midwest region                              0.000421                 3.5%
Southern region                             0.000373                 3.1%
Western region                              0.000491                 4.1%

Hispanics                                   0.000454                 3.8%
Non-hispanic whites                         0.000423                 3.5%
Non-hispanic blacks                         0.000367                 3.1%
Non-hisp/non-white/non-black                0.000509                 4.2%

All infants (< 1 year)                      0.000800                 6.7%
Nursing infants                             0.000375                 3.1%
Non-nursing infants                         0.000961                 8.0%
Children 1-6  yrs                           0.001053                 8.8%
Children 7-12 yrs                           0.000536                 4.5%

Females 13-19 (not preg or nursing)         0.000288                 2.4%
Females 20+ (not preg or nursing)           0.000341                 2.8%
Females 13-50 yrs                           0.000350                 2.9%
Females 13+ (preg/not nursing)              0.000375                 3.1%
Females 13+ (nursing)                       0.000531                 4.4%

Males 13-19 yrs                             0.000340                 2.8%
Males 20+ yrs                               0.000319                 2.7%
Seniors 55+                                 0.000359                 3.0%

Children 1-2 yrs                            0.001239                10.3%
Children 3-5 yrs                            0.001017                 8.5%
Children 6-12 yrs                           0.000574                 4.8%
Youth 13-19 yrs                             0.000315                 2.6%
Adults 20-49 yrs                            0.000320                 2.7%
Adults 50+ yrs                              0.000353                 2.9%
Females 13-49 yrs                           0.000326                 2.7%

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

Filename: C:\Documents and Settings\lcheng\My Documents\DEEM FCID lc\Fluopyram\cancer assess 2011-08-03 water.R98
Chemical: Fluopyram
RfD(Chronic): .012 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .5 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .0155
Date created/last modified: 08-03-2011/10:18:54/8          Program ver. 2.03
Comment: cancer assess 2011-08-03 water 3.5 ppb
--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code    Grp  Commodity Name                    (ppm)       #1    #2   
-------- ---- -------------------------------  ----------  ------ ------  -------
14000030 14   Almond                             0.010000   1.000  0.330  
14000031 14   Almond-babyfood                    0.010000   1.000  0.330  
14000040 14   Almond, oil                        0.010000   1.000  0.330  
14000041 14   Almond, oil-babyfood               0.010000   1.000  0.330  
11000070 11   Apple, fruit with peel             0.110000   0.700  0.400  
11000080 11   Apple, peeled fruit                0.110000   0.030  0.400  
11000081 11   Apple, peeled fruit-babyfood       0.110000   0.030  0.400  
11000090 11   Apple, dried                       0.110000   0.030  0.400  
11000091 11   Apple, dried-babyfood              0.110000   0.030  0.400  
11000100 11   Apple, juice                       0.110000   0.400  0.400  
11000101 11   Apple, juice-babyfood              0.110000   0.400  0.400  
11000110 11   Apple, sauce                       0.110000   0.010  0.400  
11000111 11   Apple, sauce-babyfood              0.110000   0.010  0.400  
95000230 O    Banana                             0.020000   1.000  1.000  
95000231 O    Banana-babyfood                    0.020000   1.000  1.000  
95000240 O    Banana, dried                      0.020000   3.900  1.000  
95000241 O    Banana, dried-babyfood             0.020000   3.900  1.000  
15000250 15   Barley, pearled barley             0.220000   1.000  0.220  
15000251 15   Barley, pearled barley-babyfood    0.220000   1.000  0.220  
15000260 15   Barley, flour                      0.220000   0.120  0.220  
15000261 15   Barley, flour-babyfood             0.220000   0.120  0.220  
15000270 15   Barley, bran                       0.220000   2.700  0.220  
06030300 6C   Bean, black, seed                  0.010000   6.100  0.070  
06030320 6C   Bean, broad, seed                  0.010000   6.100  0.070  
06030340 6C   Bean, cowpea, seed                 0.010000   6.100  0.070  
06030350 6C   Bean,  great northern, seed        0.010000   6.100  0.070  
06030360 6C   Bean, kidney, seed                 0.010000   6.100  0.070  
06030380 6C   Bean, lima, seed                   0.010000   6.100  0.070  
06030390 6C   Bean, mung, seed                   0.010000   6.100  0.070  
06030400 6C   Bean, navy, seed                   0.010000   6.100  0.070  
06030410 6C   Bean, pink, seed                   0.010000   6.100  0.070  
06030420 6C   Bean, pinto, seed                  0.010000   6.100  0.070  
21000440 M    Beef, meat                         0.000700   1.000  1.000  
21000441 M    Beef, meat-babyfood                0.000700   1.000  1.000  
21000450 M    Beef, meat, dried                  0.000700   1.920  1.000  
21000460 M    Beef, meat byproducts              0.001100   1.000  1.000  
21000461 M    Beef, meat byproducts-babyfood     0.001100   1.000  1.000  
21000470 M    Beef, fat                          0.000400   1.000  1.000  
21000471 M    Beef,fat-babyfood                  0.000400   1.000  1.000  
21000480 M    Beef, kidney                       0.001100   1.000  1.000  
21000490 M    Beef, liver                        0.006900   1.000  1.000  
21000491 M    Beef, liver-babyfood               0.006900   1.000  1.000  
01010520 1A   Beet, sugar                        0.010000   1.300  0.480  
01010521 1A   Beet, sugar-babyfood               0.010000   1.300  0.480  
01010530 1A   Beet, sugar, molasses              0.010000   0.900  0.480  
01010531 1A   Beet, sugar, molasses-babyfood     0.010000   0.900  0.480  
14000590 14   Brazil nut                         0.010000   1.000  1.000  
15000650 15   Buckwheat                          0.220000   1.000  1.000  
15000660 15   Buckwheat, flour                   0.220000   0.120  1.000  
14000680 14   Butternut                          0.010000   1.000  1.000  
14000810 14   Cashew                             0.010000   1.000  1.000  
12000900 12   Cherry                             0.190000   1.000  0.490  
12000901 12   Cherry-babyfood                    0.190000   1.000  0.490  
12000910 12   Cherry, juice                      0.190000   1.000  0.490  
12000911 12   Cherry, juice-babyfood             0.190000   1.000  0.490  
14000920 14   Chestnut                           0.010000   1.000  1.000  
40000930 P    Chicken, meat                      0.014000   1.000  1.000  
40000931 P    Chicken, meat-babyfood             0.014000   1.000  1.000  
40000940 P    Chicken, liver                     0.022000   1.000  1.000  
40000950 P    Chicken, meat byproducts           0.014000   1.000  1.000  
40000951 P    Chicken, meat byproducts-babyfoo   0.014000   1.000  1.000  
40000960 P    Chicken, fat                       0.014000   1.000  1.000  
40000961 P    Chicken, fat-babyfood              0.014000   1.000  1.000  
40000970 P    Chicken, skin                      0.014000   1.000  1.000  
40000971 P    Chicken, skin-babyfood             0.014000   1.000  1.000  
06030980 6C   Chickpea, seed                     0.010000   6.100  0.070  
06030981 6C   Chickpea, seed-babyfood            0.010000   6.100  0.070  
06030990 6C   Chickpea, flour                    0.010000   6.100  0.070  
15001200 15   Corn, field, flour                 0.010000   0.850  0.010  
15001201 15   Corn, field, flour-babyfood        0.010000   0.850  0.010  
15001210 15   Corn, field, meal                  0.010000   0.800  0.010  
15001211 15   Corn, field, meal-babyfood         0.010000   0.800  0.010  
15001220 15   Corn, field, bran                  0.010000   2.640  0.010  
15001230 15   Corn, field, starch                0.010000   0.150  0.010  
15001231 15   Corn, field, starch-babyfood       0.010000   0.150  0.010  
15001240 15   Corn, field, syrup                 0.010000   1.000  0.010  
15001241 15   Corn, field, syrup-babyfood        0.010000   1.000  0.010  
15001250 15   Corn, field, oil                   0.010000   0.350  0.010  
15001251 15   Corn, field, oil-babyfood          0.010000   0.350  0.010  
15001260 15   Corn, pop                          0.010000   1.000  0.010  
15001270 15   Corn, sweet                        0.005000   1.000  0.010  
15001271 15   Corn, sweet-babyfood               0.005000   1.000  0.010  
95001280 O    Cottonseed, oil                    0.010000   0.015  0.070  
95001281 O    Cottonseed, oil-babyfood           0.010000   0.015  0.070  
70001450 P    Egg, whole                         0.014000   1.000  1.000  
70001451 P    Egg, whole-babyfood                0.014000   1.000  1.000  
70001460 P    Egg, white                         0.014000   1.000  1.000  
70001461 P    Egg, white (solids)-babyfood       0.014000   1.000  1.000  
70001470 P    Egg, yolk                          0.014000   1.000  1.000  
70001471 P    Egg, yolk-babyfood                 0.014000   1.000  1.000  
14001550 14   Filbert                            0.010000   1.000  1.000  
14001560 14   Filbert, oil                       0.010000   1.000  1.000  
23001690 M    Goat, meat                         0.000700   1.000  1.000  
23001700 M    Goat, meat byproducts              0.001100   1.000  1.000  
23001710 M    Goat, fat                          0.000400   1.000  1.000  
23001720 M    Goat, kidney                       0.001100   1.000  1.000  
23001730 M    Goat, liver                        0.006900   1.000  1.000  
95001790 O    Grape, wine and sherry             0.400000   0.500  0.790  
06031820 6C   Guar, seed                         0.010000   6.100  0.070  
06031821 6C   Guar, seed-babyfood                0.010000   6.100  0.070  
14001850 14   Hickory nut                        0.010000   1.000  1.000  
24001890 M    Horse, meat                        0.000700   1.000  1.000  
06032030 6C   Lentil, seed                       0.010000   6.100  0.070  
14002130 14   Macadamia nut                      0.010000   1.000  1.000  
28002210 M    Meat, game                         0.000700   1.000  1.000  
27002220 D    Milk, fat                          0.002900   1.000  1.000  
27002221 D    Milk, fat - baby food/infant for   0.002900   1.000  1.000  
27012230 D    Milk, nonfat solids                0.002900   1.000  1.000  
27012231 D    Milk, nonfat solids-baby food/in   0.002900   1.000  1.000  
27022240 D    Milk, water                        0.002900   1.000  1.000  
27022241 D    Milk, water-babyfood/infant form   0.002900   1.000  1.000  
27032251 D    Milk, sugar (lactose)-baby food/   0.002900   1.000  1.000  
15002260 15   Millet, grain                      0.620000   1.000  1.000  
15002310 15   Oat, bran                          0.220000   1.000  0.230  
15002320 15   Oat, flour                         0.220000   1.000  0.230  
15002321 15   Oat, flour-babyfood                0.220000   1.000  0.230  
15002330 15   Oat, groats/rolled oats            0.220000   1.000  0.230  
15002331 15   Oat, groats/rolled oats-babyfood   0.220000   1.000  0.230  
95002630 O    Peanut                             0.011000   1.000  0.670  
95002640 O    Peanut, butter                     0.011000   0.220  0.670  
95002650 O    Peanut, oil                        0.011000   0.260  0.670  
14002690 14   Pecan                              0.010000   1.000  1.000  
14002820 14   Pistachio                          0.010000   1.000  1.000  
25002900 M    Pork, meat                         0.001000   1.000  1.000  
25002901 M    Pork, meat-babyfood                0.001000   1.000  1.000  
25002910 M    Pork, skin                         0.000500   1.000  1.000  
25002920 M    Pork, meat byproducts              0.001500   1.000  1.000  
25002921 M    Pork, meat byproducts-babyfood     0.001500   1.000  1.000  
25002930 M    Pork, fat                          0.000500   1.000  1.000  
25002931 M    Pork, fat-babyfood                 0.000500   1.000  1.000  
25002940 M    Pork, kidney                       0.001500   1.000  1.000  
25002950 M    Pork, liver                        0.009000   1.000  1.000  
01032960 1C   Potato, chips                      0.010000   0.300  0.640  
01032970 1C   Potato, dry (granules/ flakes)     0.010000   1.000  0.640  
01032971 1C   Potato, dry (granules/ flakes)-b   0.010000   1.000  0.640  
01032980 1C   Potato, flour                      0.010000   1.000  0.640  
01032981 1C   Potato, flour-babyfood             0.010000   1.000  0.640  
01032990 1C   Potato, tuber, w/peel              0.010000   1.000  0.640  
01032991 1C   Potato, tuber, w/peel-babyfood     0.010000   1.000  0.640  
01033000 1C   Potato, tuber, w/o peel            0.010000   0.200  0.640  
01033001 1C   Potato, tuber, w/o peel-babyfood   0.010000   0.200  0.640  
60003010 P    Poultry, other, meat               0.014000   1.000  1.000  
60003020 P    Poultry, other, liver              0.022000   1.000  1.000  
60003030 P    Poultry, other, meat byproducts    0.014000   1.000  1.000  
60003040 P    Poultry, other, fat                0.014000   1.000  1.000  
60003050 P    Poultry, other, skin               0.014000   1.000  1.000  
29003120 M    Rabbit, meat                       0.014000   1.000  1.000  
20003190 20   Rapeseed, oil                      0.510000   0.015  0.730  
20003191 20   Rapeseed, oil-babyfood             0.510000   0.015  0.730  
15003280 15   Rye, grain                         0.220000   1.000  0.630  
15003290 15   Rye, flour                         0.220000   1.000  0.630  
26003390 M    Sheep, meat                        0.000700   1.000  1.000  
26003391 M    Sheep, meat-babyfood               0.000700   1.000  1.000  
26003400 M    Sheep, meat byproducts             0.001100   1.000  1.000  
26003410 M    Sheep, fat                         0.000400   1.000  1.000  
26003411 M    Sheep, fat-babyfood                0.000400   1.000  1.000  
26003420 M    Sheep, kidney                      0.001100   1.000  1.000  
26003430 M    Sheep, liver                       0.006900   1.000  1.000  
15003440 15   Sorghum, grain                     0.620000   1.000  0.120  
15003450 15   Sorghum, syrup                     0.620000   1.000  0.120  
06003470 6    Soybean, seed                      0.024000   1.000  0.010  
06003480 6    Soybean, flour                     0.024000   0.040  0.010  
06003481 6    Soybean, flour-babyfood            0.024000   0.040  0.010  
06003490 6    Soybean, soy milk                  0.024000   0.010  0.010  
06003491 6    Soybean, soy milk-babyfood or in   0.024000   0.010  0.010  
06003500 6    Soybean, oil                       0.024000   0.020  0.010  
06003501 6    Soybean, oil-babyfood              0.024000   0.020  0.010  
95003590 O    Strawberry                         0.190000   1.000  0.710  
95003591 O    Strawberry-babyfood                0.190000   1.000  0.710  
95003600 O    Strawberry, juice                  0.190000   1.000  0.710  
95003601 O    Strawberry, juice-babyfood         0.190000   1.000  0.710  
15003810 15   Triticale, flour                   0.220000   1.000  1.000  
15003811 15   Triticale, flour-babyfood          0.220000   1.000  1.000  
50003820 P    Turkey, meat                       0.014000   1.000  1.000  
50003821 P    Turkey, meat-babyfood              0.014000   1.000  1.000  
50003830 P    Turkey, liver                      0.022000   1.000  1.000  
50003831 P    Turkey, liver-babyfood             0.022000   1.000  1.000  
50003840 P    Turkey, meat byproducts            0.014000   1.000  1.000  
50003841 P    Turkey, meat byproducts-babyfood   0.014000   1.000  1.000  
50003850 P    Turkey, fat                        0.014000   1.000  1.000  
50003851 P    Turkey, fat-babyfood               0.014000   1.000  1.000  
50003860 P    Turkey, skin                       0.014000   1.000  1.000  
50003861 P    Turkey, skin-babyfood              0.014000   1.000  1.000  
14003910 14   Walnut                             0.010000   1.000  1.000  
86010000 O    Water, direct, all sources         0.003490   1.000  1.000  
86020000 O    Water, indirect, all sources       0.003490   1.000  1.000  
09013990 9A   Watermelon                         0.220000   0.044  0.540  
09014000 9A   Watermelon, juice                  0.220000   0.044  0.540  
15004010 15   Wheat, grain                       0.220000   1.000  0.010  
15004011 15   Wheat, grain-babyfood              0.220000   1.000  0.010  
15004020 15   Wheat, flour                       0.220000   0.120  0.010  
15004021 15   Wheat, flour-babyfood              0.220000   0.120  0.010  
15004030 15   Wheat, germ                        0.220000   2.400  0.010  
15004040 15   Wheat, bran                        0.220000   2.700  0.010  

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


U.S. Environmental Protection Agency                                 Ver. 2.00
DEEM-FCID Chronic analysis for FLUOPYRAM                        (1994-98 data)
Residue file name: C:\Documents and Settings\lcheng\My Documents\DEEM FCID lc\Fluopyram\cancer assess 2011-08-03 water.R98
                                                     Adjustment factor #2 used.
Analysis Date 08-03-2011/10:37:29     Residue file dated: 08-03-2011/10:18:54/8
Q* = 0.0155 
COMMENT 1: cancer assess 2011-08-03 water 3.5 ppb
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg         Lifetime risk
           Subgroup                       body wt/day       (Q*= .0155)
--------------------------------------   -------------     -------------
U.S. Population (total)                     0.000188         2.92E-06

U.S. Population (spring season)             0.000193         2.99E-06
U.S. Population (summer season)             0.000188         2.92E-06
U.S. Population (autumn season)             0.000187         2.90E-06
U.S. Population (winter season)             0.000185         2.86E-06

Northeast region                            0.000194         3.00E-06
Midwest region                              0.000186         2.88E-06
Southern region                             0.000167         2.59E-06
Western region                              0.000220         3.41E-06

Hispanics                                   0.000203         3.15E-06
Non-hispanic whites                         0.000190         2.94E-06
Non-hispanic blacks                         0.000160         2.48E-06
Non-hisp/non-white/non-black                0.000205         3.18E-06

All infants (< 1 year)                      0.000434         6.72E-06
Nursing infants                             0.000186         2.88E-06
Non-nursing infants                         0.000528         8.18E-06
Children 1-6  yrs                           0.000439         6.80E-06
Children 7-12 yrs                           0.000209         3.24E-06

Females 13-19 (not preg or nursing)         0.000118         1.83E-06
Females 20+ (not preg or nursing)           0.000164         2.54E-06
Females 13-50 yrs                           0.000162         2.51E-06
Females 13+ (preg/not nursing)              0.000163         2.53E-06
Females 13+ (nursing)                       0.000210         3.26E-06

Males 13-19 yrs                             0.000130         2.02E-06
Males 20+ yrs                               0.000147         2.28E-06
Seniors 55+                                 0.000168         2.61E-06

Children 1-2 yrs                            0.000543         8.42E-06
Children 3-5 yrs                            0.000410         6.35E-06
Children 6-12 yrs                           0.000225         3.49E-06
Youth 13-19 yrs                             0.000124         1.93E-06
Adults 20-49 yrs                            0.000151         2.33E-06
Adults 50+ yrs                              0.000166         2.58E-06
Females 13-49 yrs                           0.000153         2.36E-06


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



                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            -  -  - WASHINGTON D.C., 20460
                                        -  - 
                                           
                                                                                                                                                       
                                                         OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                                                                 
                                                                 
MEMORANDUM	

SUBJECT:	Percent Crop Treated for New Uses of Fluopyram on Cantaloupe, Cucumber, Dry Beans, Peanuts, Potatoes, Pumpkin, Squash, Sugar Beet, and Watermelon.  Analysis of the Bayer Crop Science Percent Crop Treated Estimates for Rotated Crops (Wheat, Corn, Sorghum, Barley, Oats, Rye, Millet, Soybeans, Canola, Cotton, and Alfalfa) from the Combined Acreage of Dry Beans and Potatoes 
		PC#080302, DP# 387227

FROM:	Jihad Alsadek, Ph.D., Economist
		Science Information and Analysis Branch
			
		Carl Chen, Ph.D., Plant Pathologist
			Biological Analysis Branch 
		Biological and Economic Analysis Division (7503P)

THRU:		Diann Sims, Chief
		Science Information and Analysis Branch
		
		Arnet Jones, Chief
		Biological Analysis Branch
		Biological and Economic Analysis Division (7503P)	

TO:		Lisa Jones, Senior Reviewer
		Fungicide Branch
		Registration Division (7505P)

Product Review Panel:  May 4, 2011

I. SUMMARY
     
      In this memo BEAD is providing percent crop treated for new use (PCTn) estimates of the fungicide fluopyram for cantaloupe, cucumber, dry beans, peanuts, potatoes, pumpkin, squash, sugar beets, and watermelon.  To calculate these PCTn values, BEAD used recent data from the National Agricultural Statistics Service (NASS) 2002-2006, and recent proprietary data (2006-2010). 
      
      BEAD recommends that the average PCTn values in Table 1 be used for chronic risk assessment, and the maximum PCTn values be used for acute risk assessment.  For the rotational crops, BEAD recommends using the PCTn values for the rotational crops in Table 4 for chronic assessment of fluopyram for plant back after dry beans and potatoes.  
      
      At HED's request, BEAD also reviewed PPCT estimates submitted by Bayer Crop Sciences (BCS).  The term PPCT used by BCS is the equivalent of the EPA's PCTn (Bayer, 2011).  BEAD PCTn values were compared with those submitted by the registrant as shown in Table 2.   
      Additionally, HED requested that BEAD analyze the approach BCS used to estimate PCT for rotated crops (wheat, corn, sorghum, barley, oats, rye, millet, soybeans, canola, cotton, and alfalfa) from the combined acreage of dry beans and potatoes.  The results are shown in Table 4. 
      
II. FEDERAL REGISTER LANGUAGE 

      EPA estimate of the percent crop treated for the new use (PCTn) of fluopyram represent the upper bound of use expected during the pesticide's initial five years of registration; that is, the PCTn for fluopyram is a threshold of use that EPA is reasonably certain will not be exceeded for this registered use site.  The PCTn recommended for use in the chronic dietary assessment is calculated as the average percent crop treated (PCT) of the market leader or leaders (i.e., the one(s) with the greatest PCT) on that crop over the three most recent years of available data.  The PCTn recommended for use in the acute dietary assessment is the maximum observed PCT over the same period.  Comparisons are only made among pesticides of the same pesticide types (e.g., the market leader for fungicides on the use crop is selected for comparison with a new fungicide).  The market leader included in the estimation may not be the same for each year since different pesticides may dominate at different times.  
      
      Typically, EPA uses USDA/National Agricultural Statistics Service (NASS) surveys as the source data because they are publicly available and directly report values for PCT.  When a specific use crop is not reported by USDA/NASS or the NASS data are very dated, EPA uses proprietary data and calculates the PCT based on reported data on acres treated and acres grown.  If no proprietary data are available, EPA may extrapolate PCTn from other crops if the production area and pest spectrum are substantially similar.

      A retrospective analysis to validate this approach shows few cases where the PCT for the market leaders were exceeded, (EPA, 2006).  Further review of these cases identified factors contributing to the exceptionally high use of a new pesticide.  To evaluate whether the PCTn for fluopyram could be exceeded, EPA considered whether or not there may be unusually high pest pressure, as indicated in emergency exemption requests for fluopyram, the pest spectrum of the new pesticide in comparison with the market leaders, whether or not the market leaders are 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 comparison of the PCT with new uses (from tolerances established over a 10 year period) to the PCT with market leaders over that same period.  BEAD found that over 95% of the time, the new pesticide or new use of a registered pesticide is not likely to overtake the market leader for the pesticide type (i.e. fungicide in this case) and crop within the first five years following registration, (EPA, 2006).  
      
      The PCT value is taken directly from NASS data, or if proprietary data are used, BEAD calculates the PCT value by dividing the base area treated (the area treated at least one time by a given pesticide) by the crop acres grown and multiplying the value by 100.  The fungicide with the highest PCT for each data year was designated as the market leader and the PCT values associated with the market leader(s) were used to derive the PCTn values for the new crop.  The PCTn values to be used in chronic risk assessments for new uses are derived by taking the average of the market leader PCT values and the PCTn value to be used in acute risk assessments is the highest value among the available years of PCT data.  
       
		BEAD previously provided data for almonds, apples, peaches, wine grapes, oranges, pears, strawberries, and fresh tomatoes (Alsadek J. and Chen C., February 23, 2011). For this request, BEAD reviewed USDA/ NASS pesticide use surveys for fungicide usage data on cantaloupe, cucumber, peanuts, potatoes, pumpkin, squash, and watermelon.  BEAD used proprietary data for dry beans and sugar beets since NASS data are either dated or not available for these crops.
      
      Table 1. Fluopyram PCTn for Cantaloupe, Cucumber, Dry Beans, Peanuts, Potatoes, Pumpkin, Squash, Sugar Beet, and Watermelon. 
      
 Crop
Market Leader (ML) Chemical
Avg ML PCTn
Max ML PCTn
Cantaloupe[b]
Sulfur
Triflumizole
22
31
Cucumber[b]
Chlorothalonil
41
52
Dry Beans[a]
Thiophanate-Methyl
 Pyraclostrobin
7
14
Peanuts[b]
Chlorothalonil
Mancozeb 
67
70
Potatoes[b]
Mancozeb
Chlorothalonil
64
64
Pumpkin[b]
Chlorothalonil
45
57
Squash[b]
Chlorothalonil
47
54
Sugar Beets[a]
Tetraconazole
Pyraclostrobin
48
53
Watermelon[b]
Chlorothalonil
54
58
   * a Proprietary data (2006-2010)
   * b NASS data (2002-2006)
   
IV.	Evaluation of BCS PPCT Estimates and Analysis of Rotational Crop PCT Methodology Submitted by BCS

To evaluate the BCS PPCT estimates BEAD reviewed the most recent NASS data where available for all crops, except for cases where NASS data were unavailable, the most recent proprietary data were used.  The methods differ in terms of data sources and years of usage data...BCS used the average of the highest competitor values from the last five years (2005-2009) of proprietary data for all the nine crops as shown in Table 2 (Bayer, 2011).  BEAD's method, used the most recent NASS data (2002-2006) for all the crops in Table 2, except for dry beans and sugar beets, where BEAD used the most recent proprietary data (2006-2010 due to the unavailability of NASS data for these two crops.  

   Table 2. BEAD Average ML PCTns Compared to BCS PPCTs for Cantaloupe, Cucumber, Dry Beans, Peanuts, Potatoes, Pumpkin, Squash, Sugar Beets, and Watermelon
   
 Crop
Market Leader (ML) Chemical
BEAD Avg ML PCTn
BCS PPCTs
                                Difference (%)
Cantaloupe[b]
Sulfur/Triflumizole
22
34
55
Cucumber[b]
Chlorothalonil
41
47
15
Dry Beans[a]
Thiophanate-Methyl/ Pyraclostrobin
7
10
43
Peanuts[b]
Chlorothalonil/Mancozeb 
67
67
0  
Potatoes[b]
Mancozeb/ Chlorothalonil
64
60
-6
Pumpkin[b]
Chlorothalonil
45
50
11
Squash[b]
Chlorothalonil
47
54
15
Sugar beets[a]
Tetraconazole/Pyraclostrobin
48
46
-4
Watermelon[b]
Chlorothalonil
54
59
9
   * a Proprietary data (2006-2010)
   * b NASS data (2002-2006)

In order to evaluate the methodology BCS used to determine PPCTs for rotated crops (wheat, corn, sorghum, barley, oats, rye, millet, soybeans, canola, cotton, and alfalfa) from the combined acreage of dry beans and potatoes, BEAD reviewed the NASS data used by BCS as shown in Table 3.  The NASS data used by BCS for determining the PPCTs for their rotational crops analysis are publicly available.  In order to calculate the dry bean and potato treated acreage, BEAD used NASS data (2003) for potatoes (64%) and proprietary data (2006-2010) for dry beans (7%) because NASS data were not available (Table 3).  

The BCS methodology assumed that each rotational crop is planted back on both acreage of dry beans and potatoes (808,000 Acres).  It was assumed that 100 percent of the maximum available acreage (808,000 acres) could be planted back with each of the possible rotational crops, where plant back statements on the product labels reflect the ability to rotate to cereals, corn, and soybeans, only after dry beans and potatoes. (Bayer, 2011).  The treated acreage is derived by multiplying the five-year average for the combined planted acres of dry beans and potatoes by the percent of acreage treated for each of these two crops.  The PCTn for these rotational crops that follows the treated acreage of dry beans and potatoes, as shown in Table 4, is derived by dividing this fixed value (808,000 planted acres from dry beans and potatoes) by the five - year average of each individual rotational crop's planted acreage as shown in Table 3.  

As BCS explains in their Revised Portfolio submission (Bayer, 2011) "for most crops permitted rotation have been limited to primary crops for which rotational crop data are available (cotton and alfalfa).  Dry beans and potatoes require additional plant back options to canola, corn, cereals, and soybeans.  The plant back statements on the product labels have been modified to reflect these limitations on crop rotations." 

In the absence of sufficient rotational crop data, BCS defaulted to the highly conservative target crop residue data for use in the dietary risk assessment and for setting rotational crop tolerances.  A conservative estimate of PPCT for the rotational crops in BCS methodology was determined as follows.  The potential treated acres for each of the primary crops (dry beans and potatoes) which could be rotated to other crops were determined and added together.  

BCS assumed that 100 percent of that maximum available acreage (808,000 acres) could be planted back with each of the possible rotational crops as shown in Table 4 (Bayer, 2011).     
                                       
                                       
Table 3.  Fluopyram Treated Acres of Planted Dry Beans and Potatoes and Ready for Plant Back by Rotational Crops

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















Table 4.  PCTn for Rotated Crops

Data Items
Dry Beans and Potatoes Acres Treated
5 Year Avg.
PCTn Rotated Crops
Wheat
                                                                        808,000
                                                                     59,000,000
                                                                              1
Corn
                                                                        808,000
                                                                     86,000,000
                                                                              1
Sorghum
                                                                        808,000
                                                                      7,000,000
                                                                             12
Barley
                                                                        808,000
                                                                      4,000,000
                                                                             22
Oats
                                                                        808,000
                                                                      4,000,000
                                                                             23
Rye
                                                                        808,000
                                                                      1,000,000
                                                                             63
Millet
                                                                        808,000
                                                                        482,000
                                                                            100
Soybeans
                                                                        808,000
                                                                     74,000,000
                                                                              1
Canola
                                                                        808,000
                                                                      1,000,000
                                                                             73
Cotton
                                                                        808,000
                                                                     11,000,000
                                                                              7
Alfalfa
                                                                        808,000
                                                                     20,000,000
                                                                              4
Source: http://www.nass.usda.gov/Statistics_by_Subject/index.php?sector=CROPS


V.	ADDITIONAL FACTORS
      
      There are three main factors BEAD considers in evaluating the likelihood that use of a newly registered chemical or a new use will exceed the PCT for new uses:  (1) the extent of pest pressure on the crops in question; (2) the pest spectrum of the new pesticide in comparison with the market leaders as well as whether the market leaders are well-established for this use; and (3) resistance concerns with the new pesticide and the market leaders.  High pest pressure with the lack of registered controls could indicate significant demand for a new chemical.  Emergency exemptions under section 18 of FIFRA are a good indicator in regard to these situations.  On the other hand, it would be relatively difficult for a new active ingredient to gain a large portion of the market if a) it competes with the market leader(s) or others that have been extensively used for pest control including the same target pest(s), b) its new use is limited, for example, registered only for a single pest, and/or c) it is labeled for pest(s) of minor economic concern.  Finally, if the target pests are developing resistance to the market leader(s), it could indicate an advantage for the new active ingredient in the market. 
      
      Fluopyram belongs to a chemical group functioning as a succinate dehydrogenase inhibitor (SDHI) and is labeled for use on a variety of crops.  HED requested fluopyram PCTn for 10 crops at this time (BEAN #387227), which are almonds, dry beans, peanuts, potatoes, sugar beets, and five cucurbits.  A biological analysis of additional factors for the use of fluopyram on almonds has been provided in Alsadek and Chen (2011), which concludes that it is unlikely that the use of fluopyram will exceed the market leader levels on almonds.  For the remaining nine crops, the analysis of the three main factors follows (Table 5). 







      Table 5:  A List of the Registered Disease Control/Suppression on Dry Beans, Peanuts, Potatoes, Sugar Beets, and Five Cucurbits by Fluopyram 500 SC Fungicide.

                                   Commodity
                        Diseases Labeled for Fluopyram
CUCURBIT VEGETABLES
(CANTALOUPE, CUCUMBER, PUMPKIN, SQUASH, WATERMELON)
Alternaria leaf spot (Alternaria spp.); Gray mold (Botrytis cinerea); Gummy stem blight (Didymella bryoniae); Powdery mildew (Sphaeotheca fuliginea, Podosphaera xanthii, Erysiphe cichoracearum)
DRIED BEANS
Alternaria blight (Alternaria spp.); Alternaria leaf spot (Alternaria alternate); Gray mold (Botrytis cinerea); Powdery mildew (Erysiphe pisi); White mold (Sclerotinia sclerotiorum)
PEANUT
Early leaf spot (Cercospora arachidicola); Late leaf spot (Cercosporidium personatum)
POTATO
Botrytis leaf spot (Botrytis cinerea); Early blight (Alternaria solani); White mold (Sclerotinia sclerotiorum); Silver scurf (Helminthosporium solani)
SUGAR BEET
Cercospora leaf spot (Cercospora beticola); Powdery mildew (Erysiphe polygoni)
  Note: The termmo tmo to address   
      
      In addition, HED requested fluopyram PCTn for rotational crops that are alfalfa, canola, cotton, soybean, and cereal grains except rice.  After the harvest of dry beans and potatoes, 100% of the acreage treated with fluopyram is assumed to grow these rotational crops.  Thus, it is a conservative estimate and no analysis on additional factors is needed. 

CUCURBITS - The market leaders are sulfur and triflumizole for cantaloupe, and chlorothalonil for cucumber, pumpkin, squash, and watermelon.
      oo       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.
      oo       Pest spectrum:  The market leader fungicide, chlorothalonil, has been registered to control the same target diseases as fluopyram on cucumber, pumpkin, squash, and watermelon.  The market leader fungicides, sulfur and/or triflumizole, have been registered to control the same target diseases as fluopyram on cantaloupe.  Two of them, chlorothalonil and sulfur, are broad-spectrum fungicides with a multi-site mode of action, where fluopyram has a single-site mode of action.
      oo       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 would reduce its use and usage.  As a medium to high risk fungicide for resistance development, fluopyram also does not have a clear market advantage in resistance management because it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode of action, which would limit its use and usage. 

DRY BEANS - The market leaders are thiophanate-methyl and pyraclostrobin.
      oo       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.
      oo       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.
      oo       Resistance:  FRAC indicates that pyraclostrobin and thiophanate-methyl 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 dry beans.  In particular, fluopyram will unlikely gain a large portion of the market when it competes with the market leader fungicides that have been applied to control the same diseases.  It is also because fluopyram competes with other fungicide alternatives currently available on dry beans, which would reduce its use and usage.  In addition, as a medium to high risk fungicide for resistance development, fluopyram does not have a clear market advantage in resistance management because it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode of action, which would limit its use and usage.  

PEANUT - The market leaders are chlorothalonil and mancozeb.
      oo       Pest pressure:  No FIFRA Section 18 Emergency Exemption has been currently issued for the use of any fungicides to control the labeled diseases on peanuts.
      oo       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. 
      oo       Resistance:  FRAC indicates that the market leader fungicides, chlorothalonil and mancozeb, are generally considered to be at low risk for resistance development.  FRAC ranks fluopyram as medium to high risk for resistance development and indicates that resistance management is required (FRAC, 2011).
   Conclusion:  Consideration of these factors indicates that it is unlikely that the use of fluopyram will exceed the market leader levels on peanuts.  In particular, fluopyram will unlikely gain a large portion of the market when it competes with the market leaders that have been extensively used to control the same diseases.  It is also because fluopyram competes with other fungicide alternatives currently available on peanuts, which would reduce its use and usage.  As a medium to high risk fungicide for resistance development, fluopyram also does not have a clear market advantage in resistance management because it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode of action, which would limit its use and usage.

POTATO - The market leaders are chlorothalonil and mancozeb.
      oo       Pest pressure:  No FIFRA Section 18 Emergency Exemption has been currently issued for the use of any fungicides to control the labeled diseases on potatoes.
      oo       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.
      oo       Resistance:  FRAC indicates that the market leader fungicides, chlorothalonil and mancozeb, are generally considered to be at low risk for resistance.  FRAC ranks fluopyram as medium to high risk for resistance development and indicates that resistance management is required (FRAC, 2011).
   Conclusion:  Consideration of these factors indicates that it is unlikely that the use of fluopyram will exceed the market leader levels on potatoes.  In particular, fluopyram will unlikely gain a large portion of the market when it competes with the market leaders that have been extensively used to control the same diseases.  It is also because fluopyram competes with other fungicide alternatives currently available on potatoes, which would reduce its use and usage.  As a medium to high risk fungicide for resistance development, fluopyram also does not have a clear market advantage in resistance management because it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode of action, which would limit its use and usage.

SUGAR BEETS - The market leaders are pyraclostrobin and tetraconazole.
      oo       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.
      oo       Pest spectrum:  The market leader fungicides, pyraclostrobin and/or tetraconazole, have been registered to control the same target diseases as fluopyram on sugar beets.
      oo       Resistance:  FRAC indicates that pyraclostrobin and tetraconazole are high-risk-for-resistance-development fungicides.  With different chemistries, both can be rotated or tank-mixed to reduce the risk of resistance development.  It is also found that EPA Proprietary Data indicate that both were actually used to control all the main diseases labeled for fluopyram, and the fact that both were still market leaders suggests that in this particular case resistance might not be a dominating factor compared to fluopyram.  FRAC ranks fluopyram as medium to high risk for resistance development and indicates that resistance management is required (FRAC, 2011).
   Conclusion:  Consideration of these factors indicates that it is unlikely that the use of fluopyram will exceed the market leader levels on sugar beets.  In particular, fluopyram will unlikely gain a large portion of the market when it competes with the market leader fungicide that has been extensively used to control the same diseases.  It is also because fluopyram competes with other fungicide alternatives currently available on sugar beets, which would reduce its use and usage.  In addition, as a medium to high risk fungicide for resistance development, fluopyram does not have a clear market advantage in resistance management because it needs to be fitted into a fungicide rotation scheme and alternate with others with a different mode of action, which would limit its use and usage



VI.	CONCLUSIONS/RECOMMENDATIONS

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


VII.	REFERENCES

Agricultural Chemical Usage 2002 Vegetables Summary

Agricultural Chemical Usage 2004 Vegetables Summary

Agricultural Chemical Usage 2006 Vegetables Summary

Alsadek J., Chen C. 2011. Refined Percent Crop Treated for New Uses of Fluopyram on Almonds, Apples, Wine Grapes, Oranges, Peaches, Pears, Strawberries, and Tomatoes 
PC #080302, DP # 381225, DP # 378732. February 23, 2011.
  
Bayer, 2011. Revised portfolio for fluopyram use: January 19, 2011.

EPA, 2006. Memorandum: "BEAD Approach to Providing Projected Percent Crop Treated Estimates for Use in Dietary Risk Assessment in OPP", December 14, 2006.  Unpublished.

EPA Proprietary Data, 2006-2010. 

FRAC, 2011. Fungicide Resistance Action Committee. http://www.frac.info/frac/index.htm


cc: Cynthia Giles-Parker; Barbara Madden; Paula Deschamp  





                                       
