Document ID: EPA-HQ-OPP-2014-0225-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-08-06T04:00Z

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

MEMORANDUM

Date:	   April 22, 2014 

SUBJECT:	Fluopicolide.  Chronic Aggregate Dietary Exposure Assessment of Food and Drinking Water to Support a Petition for an Increased Tolerance on Tuberous and Corm Subgroup 1C Vegetables.  

PC Code:  027412
DP Barcode:  D417355
Decision No.:  481092
Registration No.:  59639-139
Petition No.: 3F8191
Regulatory Action: Section 3 
Risk Assessment Type: Single Chemical, Dietary
Case No.: NA
TXR No.: NA
CAS No.: 2008-54-4
MRID No.: None 
40 CFR: §180.627

FROM:	Peter Savoia, Chemist
		Risk Assessment Branch V
		Health Effects Division (7509P)
		
THRU:	Michael S. Metzger, Branch Chief
		Risk Assessment Branch V
		Health Effects Division (7509P)
				And
		Dennis McNeilly, Chemist 
		Meheret Negussie, Chemist
		Dietary Exposure Science Advisory Council
	Health Effects Division (7509P)
		
TO:	Tony Kish, Risk Manager
		Dominic Schuler, Risk Manager Reviewer 
		Fungicide Branch
		Registration Division (7505P)
		
Executive Summary

A chronic aggregate dietary food and drinking water exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16.  This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey/What We Eat in America, (NHANES/WWEIA).  The analyses were performed to evaluate the proposed tolerance increase on tuberous and corm subgroup 1C vegetables from 0.02 ppm to 0.3 ppm.  This action is being sought to prevent the possible seizure of commodities for over tolerance residues which were legally treated with an early season soil application that has since been restricted.  This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC Standard Operating Procedures (SOP) 2012.1. 
Acute Dietary Exposure Assessment
An acute dietary exposure analysis and risk assessment was not conducted because an endpoint attributable to a single dose has not been identified for fluopicolide.
 
Chronic Dietary Exposure Assessment
The chronic dietary exposure analysis and risk assessment made is a conservative determination that uses tolerance level residues or maximum field trial residues and a 100% crop treated assumption.   Dietary risk estimates were determined considering exposures from food and drinking water using estimated drinking water concentrations (EDWCs) for all direct and indirect water sources provided by the Environmental Fate and Effects Division (EFED).  The chronic risk estimates for fluopicolide are below the Agency's level of concern for the general U.S. population and all population subgroups (i.e., <100% of the chronic population adjusted dose).  The most highly exposed population subgroup is children ages 1-2 with an estimate for fluopicolide for food and water of 13% of the cPAD.

Cancer Dietary Exposure Assessment
A cancer dietary exposure and risk assessment was not conducted since fluopicolide is not likely to be carcinogenic to humans.

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 that 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, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References that 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," 21-JUN-2000, web link:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary exposure analysis of fluopicolide was conducted in support of the Section 3 registration action to establish tolerances on rotational corn (D407936, A. Kamel, 04/08/2013).

II.	Residue Information

The Valent U.S.A. Corporation has submitted PP# 3F8191 which requests to increase the tolerances on tuberous and corm subgroup 1C vegetables and potato processed waste for the fungicide fluopicolide.  This action is being requested since there is a potential for fluopicolide limits to be exceeded because of an unintentional labeling error which allowed for soil directed applications to be made on potatoes.  Fluopicolide is a fungicide active ingredient used for the control of plant diseases caused by Oomycetes.  Permanent tolerances are established under 40 CFR §180.627 for residues of fluopicolide which include levels previously determined on potatoes for post-emergence foliar applications.  To accommodate directed soil applications to potatoes, Valent is currently conducting field trials and will submit these data as soon as they become available.  In the interim, modeling data were submitted which are concluded to be adequate for estimating residue concentrations that may be found in potato tubers as a result of this added use (MRID No. 49177301).  
The fluopicolide residues of concern for primary and rotational crops, livestock and drinking water are shown in Table 1.  

Table 1.  Summary of Fluopicolide Residues of Concern.
Matrix
Residues included in Risk Assessment
                   Residues included in Tolerance Expression
Plants

                                 Primary Crops

All primary crops except Tuberous and Corm Vegetables
Fluopicolide (parent) and BAM 
                                 Fluopicolide

Tuberous and Corm Vegetables
Fluopicolide (parent), PCA, and BAM

                               Rotational Crops

All rotational crops except cereal grains
Fluopicolide (parent) and BAM
                                 Fluopicolide

Cereal grains - grain for human food 
Fluopicolide (parent), PCA, P1X and BAM

Cereal grains - forage/hay/straw and grain for livestock feed
Fluopicolide (parent) and BAM 

Livestock
Fluopicolide (parent) and BAM 
                                Fluopicolide[1]
Drinking Water
Fluopicolide (parent) and BAM 
                                Not applicable
1  Upon submission of additional information, the Fluopicolide Team revisited the residues of concern in animal commodities and determined that the tolerance should be expressed as parent compound and that the ROC for risk assessment purposes was parent and BAM. (D370762, D. Davis, 8/19/10)

In determining the residues of concern, fluopicolide was concluded to share a common metabolite, BAM with another active ingredient dichlobenil.  For risk assessment purposes, a determination is also needed to evaluate if BAM residues resulting from this new use of the parent compound will impact dietary exposure.  For the prior action which registered the foliar use of fluopicolide on potatoes, a separate dietary risk assessment was completed for the BAM metabolite (D381051 and D381052, D. S. Davis, 09/09/2010).  These results found that the addition of this use for fluopicolide did not significantly impact the overall dietary assessment.  Further, when fluopicolide is applied, very little is converted to BAM in contrast to the use of dichlobenil which results in much higher residues.  As such, there is no expectation that BAM residues will result from allowing soil directed treatments to be made to potatoes as well.  The prior BAM dietary exposure analysis and risk assessment is therefore concluded to be adequate in supporting this petition.  All other metabolites referenced above are assumed to have equivalent or less toxicity than the parent compound and will be included with the parent compound in this dietary risk assessment.        

For this dietary assessment, tolerance level residues were utilized for the established uses of fluopicolide except for rotational wheat commodities, and tuberous and corm vegetables.  Maximum residue values were used for these crops since metabolite concentrations are required to be included for risk assessment.  In regard to rotational wheat commodities, the maximum residues from the field trial data were used to calculate an appropriate residue value since the parent compound along with the PCA and P1X metabolites are used for risk assessment.  The maximum metabolite residues obtained were converted to parent equivalents and added to the maximum fluopicolide residue value observed in the field trial data to derive a total residue value.  The total residue calculations for rotational wheat commodities were carried forward from the previous dietary assessment made for fluopicolide on these commodities (D381050, D. S. Davis, 08/19/2010).  The rotational wheat total residue calculations are shown below in Table 2.
Table 2.  Calculation of Fluopicolide Residues of Wheat for Dietary Assessment.[1]
Matrix
Residues of Concern for Risk Assessment[2]
Max Reported Residues (ppm)
Conversion Factors[3]
Max Residues Expressed as Parent Equivalents (ppm)
Wheat grain
Parent
0.014
Not applicable
0.014

PCA
0.062
1.701
0.10546

P1X
0.075
1.515
0.1136

                                     Total
0.2331 ≈ 0.23
Wheat germ 
Parent
0.014
Not applicable
0.0658

PCA
0.10546
1.701
0.09491

P1X
0.1136
1.515
0.07952

                                     Total
0.24023 ≈ 0.24
Wheat bran
Parent
0.014
Not applicable
0.0420

PCA
0.10546
1.701
0.2004

P1X
0.1136
1.515
0.2499

                                     Total
0.4923 ≈ 0.49
1 Rotational wheat commodities were previously assessed in a separate memo (D381050, D. S. Davis, 08/19/2010).
[2] BAM is assessed in a separate memo (D381051 and D381052, D. S. Davis, 09/09/2010).
[3] Conversion factors convert residues reported as PCA and P1X to fluopicolide (parent) equivalents using molecular weight ratios.  Molecular weights are 383.584 for parent, 225.554 for PCA, and 253.196 for P1X.  Conversion factors are calculated as follows: 383.584 / 225.554 = 1.701 for conversion of PCA to parent equivalents; 383.584 / 253.196 = 1.515 for conversion of P1X to parent equivalents.

In regard to rotational corn, tolerance-level residues were utilized for assessing these established uses which followed the previous dietary assessment made for fluopicolide on these commodities (D407936, A. Kamel, 04/08/2013).  Empirical processing factors were incorporated, except for corn syrup where the default processing factor was included.  Since metabolite residues of PAC and P1X were not detected (below the limit of detection, LOD) in grain or processed fractions at the 1x and 2x application rates, half the LOD (0.005 ppm) of each metabolite was added to the residues of the parent fluopicolide for this assessment.  As a result, a value of 0.02 ppm was used for corn commodities.

For tuberous and corm commodities, an appropriate residue value for risk assessment includes the parent compound and PCA metabolite.  In order to estimate the level of fluopicolide that can occur from directed soil application, the registrant has provided modeling calculations for tolerance setting purposes while field trials are completed.  This was represented by modeling the maximum application rate for directed soil treatment to estimate the percentage of fluopicolide residues which could be translocated to potato tubers.  To obtain a maximum residue value for risk assessment, a ratio was therefore determined for calculating a correlated level of the PCA metabolite.  This was done by evaluating all of the available studies relevant for determining the residues of fluopicolide in root and tuber crops (potato metabolism study, potato field trial studies, and confined rotational crop study).  Upon comparison, the 29 day plant-back interval for radish roots which tested the pyridinyl label examined in the confined rotational crop study gave the most conservative ratio (82%).  A maximum residue value of 0.54 ppm is therefore used for tuberous and corm vegetables which is determined by multiplying the modeled fluopicolide value recommended for tolerance (0.3 ppm) by a factor of 1.8X         

There are no livestock tolerances required to support the established uses of fluopicolide or for an increased tolerance on tuberous and corm vegetables following this action.  The livestock dietary burden was determined to be unaffected by the increased tolerance which is being recommended on potato processed waste (D417354, P. Savoia, 04/22/2014).  Empirical data were used to determine appropriate values for all relevant processed commodities.  DEEM 7.81 default concentration factors were otherwise applied to the raw agricultural commodity residue level in the absence of empirical data.  The processing factors used for this chronic dietary exposure and risk assessment are shown in Table 3 below.

Table 3.  Summary of Processing Factors Used for Fluopicolide Dietary Analysis.
RAC
Processed Commodity
Processing Factor
Comment
Beet, Sugar
Molasses
1.0
MRID 47021707  -  Residues of fluopicolide do concentrate slightly in molasses, however, when the highest average field trial (HAFT) is multiplied by the concentration factor of 1.6X, the resulting residue value is below the tolerance set on the RAC.  Since the RAC tolerance is used in the assessment, no additional PF is needed.
Grapes
Grape Juice

1.0
MRIDs 4647102, 46474104, 46474105, 46708542  -  Residues of fluopicolide are not likely to concentrate in juice or wine.  Residues do concentrate in raisins; however a processed commodity tolerance of 6.0 ppm is established for raisins and is used in the assessment; since concentration is already accounted for an additional processing factor is not required.  

Raisins

1.0

Wine

1.0

Onions
Onions, dehydrated or dry
9.0
DEEM 7.81 default processing factor
Potato
Flakes & Flour
1.0
MRID 46708545  -  Residues of fluopicolide in potato flakes and chips are not likely to exceed the established RAC tolerance.  

Chips
1.0

Tomato
Tomato Juice
1.0
MRID 46708543  -  Residues of fluopicolide in tomato juice, paste or puree are not likely to exceed the established RAC tolerance.

Tomato Paste
1.0

Tomato Puree
1.0

Tomatoes, dried
14.3
DEEM 7.81 default processing factor

III.  Percent Crop Treated Information

The dietary assessment performed in support of this action is considered to be a highly conservative analysis.  It includes tolerance level residues or maximum field trial residue levels for all crops, assumes 100% crop treated and uses empirical or default DEEM processing factors.  

IV.  Drinking Water Data
   
Estimated Drinking Water Concentrations (EDWCs) for fluopicolide were recently determined to support the establishment of tolerances on tuberous and corm subgroup 1C vegetables for post-emergence foliar applications.  These analyses were provided by the Environmental Fate and Effects Division (EFED) in the memorandum "Tier II Drinking Water Exposure Assessment for Fluopicolide and its Major Degradate, 2,6-Dichlorbenzamide (BAM) for Use on Potatoes, Carrots, Sugar Beets and Brassica (Cole) Leafy Vegetables" (D370764, R. Miller, 07/20/2010).  The need for updated EDWCs is currently being assessed in order to support a pending new use registration which has been recently requested.  An updated dietary exposure and risk assessment is anticipated which will evaluate all of the established uses of fluopicolide.  In the interim, the previous drinking water assessment will remain applicable for supporting this current action.      
In the EFED assessment, EDWCs are provided separately for the parent compound and its BAM metabolite; however, since this risk assessment includes fluopicolide only in drinking water, BAM results are not discussed further here.

Fluopicolide is not included as an analyte monitored in U.S. surface and groundwater under the USGS's National Water Quality Assessment (NAWQA) program.  Since there is not adequate monitoring data available, surface water concentrations were estimated using the Tier II model PRZM version 3.12/ EXAMS version 2.98. Ground water concentrations were estimated using the Tier I SCI-GROW model.  The model and its description are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/.  

The recommended estimated drinking water concentrations (EDWCs) for fluopicolide are summarized below in Table 4.

Table 4.  Summary of Estimated Surface Water and Groundwater Concentrations for Fluopicolide.

                                 Fluopicolide

                          Surface Water Conc., ppb 1
                           Groundwater Conc., ppb 2
Acute
                                     25.50
                                      0.5
Chronic (non-cancer)
                                     24.14
                                       
Chronic (cancer)
                                     22.36
                                       
[1] From the Tier II PRZM-EXAMS - Index Reservoir model.  Highest surface water EDWC assumed a maximum application rate of 0.125 lbs ai/A, a maximum number of applications of 3 and an RTI of 7 days.  For the premix label a maximum application rate of 0.09 lbs ai/A, a maximum of 4 applications and a 10 day RTI were evaluated but did not lead to the highest EDWC values.  The scenario that gave the maximum acute and chronic (non cancer) EDWCs were aerial application to Florida Carrots.  The scenario that gave the maximum cancer EDWC was aerial application to potatoes.
 [2] From the SCI-GROW model assuming 3 applications of   0.125 lbs ai/A.
Note:  Since only a chronic dietary assessment was conducted, the value of 24.14 ppb is the value used to calculate exposure and risk.

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

The fluopicolide chronic dietary exposure and risk assessment was conducted using the DEEM-FCID(TM), Version 3.16.  This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).   These 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 2003-2008 WWEIA 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 50-99 years old.

For chronic dietary exposure assessment, 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 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 tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

VI.	Toxicological Information

A summary of the toxicological endpoints and doses chosen for the relevant exposure scenarios for human risk assessment are found below in Table 5.  The need for updating any of the toxicological points of departure will be reassessed in addressing the new use registration that has been recently requested for fluopicolide.  For the purpose of this action, the prior toxicological endpoints and doses will therefore remain applicable for human risk assessment.      

Table 5.   Summary of Toxicological Doses and Endpoints for Fluopicolide for Use in Dietary Exposure Risk Assessment.
Exposure/
Scenario
Point of Departure
Uncertainty/FQPA Safety Factors
RfD, PAD, Level of Concern 
Study and Toxicological Effects
Acute Dietary (All Populations)
An endpoint attributable to a single dose was not identified from the available data.
Chronic Dietary (All Populations)
Maternal NOAEL=20 mg/kg/day

NOAEL =31.5 mg/kg/day (co-critical study)
                                    UFA=10x
                                    UFH=10x
                                 FQPA SF = 1X
                                       
Chronic RfD = 
cRfD = 0.2 mg/kg/day

cPAD = 0.2 mg/kg/day
Developmental Toxicity Study in Rabbits
LOAEL (maternal) = 60 mg/kg/day based on death, abortions/premature deliveries, decreased food consumption and body weight gain.

Chronic Oncogenicity Study in Rats (co-critical study)
LOAEL = 109.4 mg/kg/day based on decreased body weight gain and increased thyroid weight and increased incidence of thyroid lesions.
Cancer (oral, dermal, inhalation)
        Classification:  "Not Likely to be Carcinogenic to Humans"
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 (c = chronic).  RfD = reference dose. 
VII.  Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The following summarizes the DEEM-FCID (ver. 3.16) chronic exposure analyses.  The chronic aggregate (food + water) analysis was performed using DEEM-FCID estimating the dietary exposure of the U.S. population and various population subgroups.  The results reported below 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
An acute dietary exposure and risk assessment was not conducted because an endpoint attributable to a single dose has not been identified for fluopicolide.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis
 The established uses along with an increased tolerance on tuberous and corm subgroup 1C vegetables for fluopicolide will result in an estimated exposure to the U.S. Population which is equivalent to 7.7% of the cPAD.  The most highly exposed subgroup is children 1  -  2 years of age with an estimated exposure equivalent to 13% of the cPAD.  Results for all subpopulations are shown in the table below.  
 
 Table 7.  Chronic Dietary Exposure and Risk Estimates for Fluopicolide.
 Population Subgroup
                                     PAD[1]
                                  (mg/kg/day)
                                   DEEM-FCID
 
 
                                    Exposure
                                  (mg/kg/day)
                                     % PAD
U.S. Population
                                      0.2
                                    0.015484
                                      7.7
All infants (< 1 yr)
 
                                    0.010881
                                      5.4
Children 1-2 yrs
 
                                    0.025122
                                       13
Children 3-5 yrs
 
                                    0.023460
                                       12
Children 6-12 yrs
 
                                    0.014866
                                      7.4
Youth 13-19 yrs
 
                                    0.011526
                                      5.8
Adults 20-49 yrs
 
                                    0.015214
                                      7.6
Adults 50-99 yrs
 
                                    0.015629
                                      7.8
Females 13-49 yrs
 
                                    0.015484
                                      7.7
 			[1] Chronic dietary analysis derived from a 0.2 mg/kg/day cPAD for the general population.
 			2 Highest exposures found for assessment is noted in bold.
 
Results of Cancer Dietary Exposure Analysis
A cancer dietary exposure and risk assessment was not conducted since fluopicolide is not likely to be carcinogenic to humans.  

 VIII.	Characterization of Inputs/Outputs
 
This assessment is considered highly conservative as it includes tolerance level residues or maximum field trial residue levels for all crops, assumes 100% crop treated and uses empirical or default DEEM processing factors.  To provide a comparison for reference, the chronic dietary results for the analysis of food exposures (only) are presented in attachment 3.   
 
 
 
 
 IX.	Conclusions
 
 The chronic dietary risk from the established and newly proposed uses of fluopicolide is not of concern for the U.S. population and all population subgroups.  This assessment is not likely to underestimate risk.  

References

DP No.:	D407936
Subject:	Fluopicolide Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Tolerances on Rotational Corn.  
From:	A. Kamel
To:	T. Kish and D. Schuler
Dated:	04/08/2013
MRID No.:	48809201, 48842201

MRID No.:	49177301 Allen, R. (2013) Fluopicolide: Proposal for a Revised Tolerance on Potato.  Laboratory Project ID VP-38438.  Unpublished study prepared by Valent Technical Center.  19 p.

DP No.:	D417354
Subject:	Fluopicolide.  Section 3 Registration of an Amended Tolerance on Tuberous and Corm Subgroup 1C Vegetables and Potato Processed Waste for Fluopicolide. 
From:	P. Savoia
To:	D. Schuler and T. Kish
Dated:	04/22/2014
MRID No.:	49177301

DP No.:	D370762
Subject:	Fluopicolide.  Petitions to Establish Tolerances on Potatoes, Sugar Beets, Carrots, Rotational Wheat, and Animal Commodities.  Summary of Analytical Chemistry and Residue Data.  
From:	D. S. Davis
To:	J. Whitehurst and T. Kish
Dated:	08/19/2010
MRID No.:	47745901 and 47745902

DP No.:	D381051 and 381052
            Subject:	2,6-Dichlorobenzamide (BAM).  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment to Support New Section 3 Uses of Fluopicolide on Brassica Leafy Greens Subgroup 5B, Potatoes, Sugar Beets, and Carrots, and to Allow Rotation to Wheat.  
            From:	D. S. Davis
To:	J. Whitehurst and T. Kish
Dated:	09/09/2010
MRID No.:	None

DP No.:	D381050
Subject:	Fluopicolide.  Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment to Support New Section 3 Uses on Brassica Leafy Greens Subgroup 5B, Potatoes, Sugar Beets, Carrots, and Rotational Wheat.  
From:	D. S. Davis
To:	J. Whitehurst and T. Kish
Dated:	08/19/2010
MRID No.:	None

DP No.:	D370764
Subject:	Tier II Drinking Water Exposure Assessment for Fluopicolide and its Major Degradate, 2,6-Dichlorbenzamide (BAM) for Uses on Potatoes, Carrots, Sugar Beets, and Brassica (Cole) Leafy Vegetables.  
From:	R. Miller
To:	T. Kish and J. Whitehurst 
Dated:	07/20/2010
MRID No.:	None

 X.		List of Attachments
   
1.	  Attachment 1: Chronic Dietary Input File.
2.	Attachment 2: Chronic Dietary Results (Food and Drinking Water) File.
 3.	Attachment 3: Chronic Dietary Results (Food Only) File.

                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       

                                 ATTACHMENT 1

Filename: G:\Fluopicolide Dietary\Residue Data Files\FLUOPIC_Amended CG1C Tolerances_March 2014_ CHRONIC _Food and Water_W.R08
Chemical: fluopicolide 027412
RfD(Chronic): .2 mg/kg bw/day  NOEL(Chronic): 20 mg/kg bw/day
RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 03-13-2014/09:33:51       Program ver. 3.16, 03-08-d
Comment: PP#3F8191 Amended CG1C Tolerances (Food and Water)
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2   
---------- ---- -------------------------------  ----------  ------ ------  -------
0401005000 4A   Amaranth, leafy                   25.000000   1.000  1.000  
0103015000 1CD  Arrowroot, flour                   0.540000   1.000  1.000  5F7016
0103015001 1CD  Arrowroot, flour-babyfood          0.540000   1.000  1.000  5F7016
0103017000 1CD  Artichoke, Jerusalem               0.540000   1.000  1.000  5F7016
0401018000 4A   Arugula                           25.000000   1.000  1.000  
0902021000 9B   Balsam pear                        0.500000   1.000  1.000  
0101050000 1AB  Beet, garden, roots                0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0101050001 1AB  Beet, garden, roots-babyfood       0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0200051000 2    Beet, garden, tops                15.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0101052000 1A   Beet, sugar                        0.150000   1.000  1.000  new us
            Full comment: new use
0101053000 1A   Beet, sugar, molasses              0.150000   1.000  1.000  new us
            Full comment: new use
0101053001 1A   Beet, sugar, molasses-babyfood     0.150000   1.000  1.000  new us
            Full comment: new use
0101052001 1A   Beet, sugar-babyfood               0.150000   1.000  1.000  new us
            Full comment: new use
0501061000 5A   Broccoli                           5.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0502063000 5B   Broccoli raab                     18.000000   1.000  1.000  9F7617
0501062000 5A   Broccoli, Chinese                  5.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0501061001 5A   Broccoli-babyfood                  5.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0501064000 5A   Brussels sprouts                   5.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0101067000 1AB  Burdock                            0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0501069000 5A   Cabbage                            5.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0502070000 5B   Cabbage, Chinese, bok choy        18.000000   1.000  1.000  9F7617
0501072000 5A   Cabbage, Chinese, mustard          5.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0501071000 5A   Cabbage, Chinese, napa             5.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0901075000 9A   Cantaloupe                         0.500000   1.000  1.000  
0402076000 4B   Cardoon                           25.000000   1.000  1.000  
0101078000 1AB  Carrot                             0.150000   1.000  1.000  new us
            Full comment: new use
0101079000 1AB  Carrot, juice                      0.150000   1.000  1.000  new us
            Full comment: new use
0101078001 1AB  Carrot-babyfood                    0.150000   1.000  1.000  new us
            Full comment: new use
0103082000 1CD  Cassava                            0.540000   1.000  1.000  5F7016
0103082001 1CD  Cassava-babyfood                   0.540000   1.000  1.000  5F7016
0501083000 5A   Cauliflower                        5.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0101084000 1AB  Celeriac                           0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0402085000 4B   Celery                            25.000000   1.000  1.000  
0402086000 4B   Celery, juice                     25.000000   1.000  1.000  
0402085001 4B   Celery-babyfood                   25.000000   1.000  1.000  
0402087000 4B   Celtuce                           25.000000   1.000  1.000  
0902088000 9B   Chayote, fruit                     0.500000   1.000  1.000  
0101100000 1AB  Chicory, roots                     0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0200101000 2    Chicory, tops                     15.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0902102000 9B   Chinese waxgourd                   0.500000   1.000  1.000  
0302103000 3B   Chive, fresh leaves                7.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0401104000 4A   Chrysanthemum, garland            25.000000   1.000  1.000  
0502117000 5B   Collards                          18.000000   1.000  1.000  9F7617
1500122000 15   Corn, field, bran                  0.020000   1.000  1.000  2F8099
1500120000 15   Corn, field, flour                 0.020000   1.000  1.000  2F8099
1500120001 15   Corn, field, flour-babyfood        0.020000   1.000  1.000  2F8099
1500121000 15   Corn, field, meal                  0.020000   1.000  1.000  2F8099
1500121001 15   Corn, field, meal-babyfood         0.020000   1.000  1.000  2F8099
1500125000 15   Corn, field, oil                   0.020000   2.100  1.000  2F8099
1500125001 15   Corn, field, oil-babyfood          0.020000   2.100  1.000  2F8099
1500123000 15   Corn, field, starch                0.020000   1.000  1.000  2F8099
1500123001 15   Corn, field, starch-babyfood       0.020000   1.000  1.000  2F8099
1500124000 15   Corn, field, syrup                 0.020000   1.500  1.000  2F8099
1500124001 15   Corn, field, syrup-babyfood        0.020000   1.500  1.000  2F8099
1500126000 15   Corn, pop                          0.020000   1.000  1.000  2F8099
0401133000 4A   Cress, garden                     25.000000   1.000  1.000  
0401134000 4A   Cress, upland                     25.000000   1.000  1.000  
0902135000 9B   Cucumber                           0.500000   1.000  1.000  
0401138000 4A   Dandelion, leaves                 25.000000   1.000  1.000  
0103139000 1CD  Dasheen, corm                      0.540000   1.000  1.000  5F7016
0200140000 2    Dasheen, leaves                   15.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0802148000 8BC  Eggplant                           1.600000   1.000  1.000  
0401150000 4A   Endive                            25.000000   1.000  1.000  
0402152000 4B   Fennel, Florence                  25.000000   1.000  1.000  
0301165000 3A   Garlic, bulb                       7.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0301165001 3A   Garlic, bulb-babyfood              7.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0103166000 1CD  Ginger                             0.540000   1.000  1.000  5F7016
0103167000 1CD  Ginger, dried                      0.540000   1.000  1.000  5F7016
0103166001 1CD  Ginger-babyfood                    0.540000   1.000  1.000  5F7016
0101168000 1AB  Ginseng, dried                     0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
1304175000 13D  Grape                              2.000000   1.000  1.000  
1304176000 13D  Grape, juice                       2.000000   1.000  1.000  
1304176001 13D  Grape, juice-babyfood              2.000000   1.000  1.000  
9500177000 O    Grape, leaves                      2.000000   1.000  1.000  
9500178000 O    Grape, raisin                      6.000000   1.000  1.000  
1304179000 13D  Grape, wine and sherry             2.000000   1.000  1.000  
0901187000 9A   Honeydew melon                     0.500000   1.000  1.000  
0101190000 1AB  Horseradish                        0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0502194000 5B   Kale                              18.000000   1.000  1.000  9F7617
0501196000 5A   Kohlrabi                           5.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0302198000 3B   Leek                               7.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0401204000 4A   Lettuce, head                     25.000000   1.000  1.000  
0401205000 4A   Lettuce, leaf                     25.000000   1.000  1.000  
0502229000 5B   Mustard greens                    18.000000   1.000  1.000  9F7617
0802234000 8BC  Okra                               1.600000   1.000  1.000  
0301237000 3A   Onion, bulb                        7.000000   1.000  1.000  DEEM d
            Full comment: DEEM default PF
0301238000 3A   Onion, bulb, dried                 7.000000   9.000  1.000  DEEM d
            Full comment: DEEM default PF
0301238001 3A   Onion, bulb, dried-babyfood        7.000000   9.000  1.000  DEEM d
            Full comment: DEEM default PF
0301237001 3A   Onion, bulb-babyfood               7.000000   1.000  1.000  DEEM d
            Full comment: DEEM default PF
0302239000 3B   Onion, green                       7.000000   1.000  1.000  
0401248000 4A   Parsley, leaves                   25.000000   1.000  1.000  
0101250000 1AB  Parsley, turnip rooted             0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0101251000 1AB  Parsnip                            0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0101251001 1AB  Parsnip-babyfood                   0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0802270000 8B   Pepper, bell                       1.600000   1.000  1.000  
0802271000 8B   Pepper, bell, dried                1.600000   1.000  1.000  
0802271001 8B   Pepper, bell, dried-babyfood       1.600000   1.000  1.000  
0802270001 8B   Pepper, bell-babyfood              1.600000   1.000  1.000  
0802272000 8BC  Pepper, nonbell                    1.600000   1.000  1.000  
0802273000 8BC  Pepper, nonbell, dried             1.600000   1.000  1.000  
0802272001 8BC  Pepper, nonbell-babyfood           1.600000   1.000  1.000  
0103296000 1C   Potato, chips                      0.540000   1.000  1.000  new us
            Full comment: new use; empirical PF
0103297000 1C   Potato, dry (granules/ flakes)     0.540000   1.000  1.000  new us
            Full comment: new use; empirical PF
0103297001 1C   Potato, dry (granules/ flakes)-b   0.540000   1.000  1.000  new us
            Full comment: new use; empirical PF
0103298000 1C   Potato, flour                      0.540000   1.000  1.000  new us
            Full comment: new use; empirical PF
0103298001 1C   Potato, flour-babyfood             0.540000   1.000  1.000  new us
            Full comment: new use; empirical PF
0103300000 1C   Potato, tuber, w/o peel            0.540000   1.000  1.000  new us
            Full comment: new use
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.540000   1.000  1.000  new us
            Full comment: new use
0103299000 1C   Potato, tuber, w/peel              0.540000   1.000  1.000  new us
            Full comment: new use
0103299001 1C   Potato, tuber, w/peel-babyfood     0.540000   1.000  1.000  new us
            Full comment: new use
0902308000 9B   Pumpkin                            0.500000   1.000  1.000  
0902309000 9B   Pumpkin, seed                      0.500000   1.000  1.000  
0401313000 4A   Radicchio                         25.000000   1.000  1.000  
0101316000 1AB  Radish, Oriental, roots            0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0200317000 2    Radish, Oriental, tops            15.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0101314000 1AB  Radish, roots                      0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0200315000 2    Radish, tops                      15.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0502318000 5B   Rape greens                       18.000000   1.000  1.000  9F7617
0402322000 4B   Rhubarb                           25.000000   1.000  1.000  
0101327000 1AB  Rutabaga                           0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0101331000 1AB  Salsify, roots                     0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0200332000 2    Salsify, tops                     15.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0302338500 3B   Shallot, fresh leaves              7.000000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
0401355000 4A   Spinach                           25.000000   1.000  1.000  
0401355001 4A   Spinach-babyfood                  25.000000   1.000  1.000  
0902356000 9B   Squash, summer                     0.500000   1.000  1.000  
0902356001 9B   Squash, summer-babyfood            0.500000   1.000  1.000  
0902357000 9B   Squash, winter                     0.500000   1.000  1.000  
0902357001 9B   Squash, winter-babyfood            0.500000   1.000  1.000  
0103366000 1CD  Sweet potato                       0.540000   1.000  1.000  5F7016
0103366001 1CD  Sweet potato-babyfood              0.540000   1.000  1.000  5F7016
0402367000 4B   Swiss chard                       25.000000   1.000  1.000  
0103371000 1CD  Tanier, corm                       0.540000   1.000  1.000  5F7016
0801374000 8A   Tomatillo                          1.600000   1.000  1.000  
0801375000 8A   Tomato                             1.600000   1.000  1.000  
0801378000 8A   Tomato, dried                      1.600000  14.300  1.000  DEEM d
            Full comment: DEEM default PF
0801378001 8A   Tomato, dried-babyfood             1.600000  14.300  1.000  DEEM d
            Full comment: DEEM default PF
0801379000 8A   Tomato, juice                      1.600000   1.000  1.000  Empiri
            Full comment: Empirical PF
0801376000 8A   Tomato, paste                      1.600000   1.000  1.000  Empiri
            Full comment: Empirical PF
0801376001 8A   Tomato, paste-babyfood             1.600000   1.000  1.000  Empiri
            Full comment: Empirical PF
0801377000 8A   Tomato, puree                      1.600000   1.000  1.000  Empiri
            Full comment: Empirical PF
0801377001 8A   Tomato, puree-babyfood             1.600000   1.000  1.000  Empiri
            Full comment: Empirical PF
0801375001 8A   Tomato-babyfood                    1.600000   1.000  1.000  
0103387000 1CD  Turmeric                           0.540000   1.000  1.000  5F7016
0502389000 5B   Turnip, greens                    15.000000   1.000  1.000  Crop G
            Full comment: Crop Group 2
0101388000 1AB  Turnip, roots                      0.150000   1.000  1.000  PP#7E7
            Full comment: PP#7E7172
8601000000 86A  Water, direct, all sources         0.024140   1.000  1.000  
8602000000 86B  Water, indirect, all sources       0.024140   1.000  1.000  
0901399000 9A   Watermelon                         0.500000   1.000  1.000  
0901400000 9A   Watermelon, juice                  0.500000   1.000  1.000  
1500404000 15   Wheat, bran                        0.490000   1.000  1.000  rotati
            Full comment: rotational crop use
1500402000 15   Wheat, flour                       0.230000   1.000  1.000  rotati
            Full comment: rotational crop use
1500402001 15   Wheat, flour-babyfood              0.230000   1.000  1.000  rotati
            Full comment: rotational crop use
1500403000 15   Wheat, germ                        0.240000   1.000  1.000  rotati
            Full comment: rotational crop use
1500401000 15   Wheat, grain                       0.230000   1.000  1.000  rotati
            Full comment: rotational crop use
1500401001 15   Wheat, grain-babyfood              0.230000   1.000  1.000  rotati
            Full comment: rotational crop use
0103407000 1CD  Yam bean                           0.540000   1.000  1.000  5F7016
0103406000 1CD  Yam, true                          0.540000   1.000  1.000  5F7016

                                 ATTACHMENT 2

US EPA                                                          Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for FLUOPICOLIDE 027412         NHANES 2003-2008 2-day
Residue file name: G:\Fluopicolide Dietary\Residue Data Files\FLUOPIC_Amended CG1C Tolerances_March 2014_ CHRONIC _Food and Water_W.R08
                                                 Adjustment factor #2 NOT used.
Analysis Date 03-13-2014/09:38:58     Residue file dated: 03-13-2014/09:33:51
Reference dose (RfD, Chronic) = .2 mg/kg bw/day
COMMENT 1: PP#3F8191 Amended CG1C Tolerances (Food and Water)
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ----------------
Total US Population                         0.015484                 7.7%
Hispanic                                    0.014496                 7.2%
Non-Hisp-White                              0.015948                 8.0%
Non-Hisp-Black                              0.012939                 6.5%
Non-Hisp-Other                              0.017915                 9.0%
Nursing Infants                             0.006674                 3.3%
Non-Nursing Infants                         0.012759                 6.4%
Female 13+ PREG                             0.014187                 7.1%
Children 1-6                                0.023496                11.7%
Children 7-12                               0.013956                 7.0%
Male 13-19                                  0.010965                 5.5%
Female 13-19/NP                             0.012091                 6.0%
Male 20+                                    0.014183                 7.1%
Female 20+/NP                               0.016524                 8.3%
Seniors 55+                                 0.015507                 7.8%
All Infants                                 0.010881                 5.4%
Female 13-50                                0.015467                 7.7%
Children 1-2                                0.025122                12.6%
Children 3-5                                0.023460                11.7%
Children 6-12                               0.014866                 7.4%
Youth 13-19                                 0.011526                 5.8%
Adults 20-49                                0.015214                 7.6%
Adults 50-99                                0.015629                 7.8%
Female 13-49                                0.015484                 7.7%

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

                                 ATTACHMENT 3

US EPA                                                          Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for FLUOPICOLIDE 027412         NHANES 2003-2008 2-day
Residue file name: G:\Fluopicolide Dietary\Residue Data Files\FLUOPIC_Amended CG1C Tolerances_March 2014_ CHRONIC _Food Only_W.R08
                                                 Adjustment factor #2 NOT used.
Analysis Date 03-13-2014/09:41:09     Residue file dated: 03-13-2014/09:35:23
Reference dose (RfD, Chronic) = .2 mg/kg bw/day
COMMENT 1: PP#3F8191 Amended CG1C Tolerances (Food Only)
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ----------------
Total US Population                         0.014978                 7.5%
Hispanic                                    0.014014                 7.0%
Non-Hisp-White                              0.015428                 7.7%
Non-Hisp-Black                              0.012522                 6.3%
Non-Hisp-Other                              0.017333                 8.7%
Nursing Infants                             0.006217                 3.1%
Non-Nursing Infants                         0.011078                 5.5%
Female 13+ PREG                             0.013711                 6.9%
Children 1-6                                0.022849                11.4%
Children 7-12                               0.013535                 6.8%
Male 13-19                                  0.010617                 5.3%
Female 13-19/NP                             0.011701                 5.9%
Male 20+                                    0.013712                 6.9%
Female 20+/NP                               0.015993                 8.0%
Seniors 55+                                 0.015018                 7.5%
All Infants                                 0.009577                 4.8%
Female 13-50                                0.014964                 7.5%
Children 1-2                                0.024393                12.2%
Children 3-5                                0.022845                11.4%
Children 6-12                               0.014423                 7.2%
Youth 13-19                                 0.011158                 5.6%
Adults 20-49                                0.014710                 7.4%
Adults 50-99                                0.015131                 7.6%
Female 13-49                                0.014982                 7.5%

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