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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. 
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

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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/EPAPEST/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). 
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

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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 Fluopicolide1

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.
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Table 2. Calculation of Fluopicolide Residues of Wheat for Dietary Assessment.1

Matrix

Residues of 

Concern for Risk 

Assessment2

Max Reported 

Residues 

(ppm)

Conversion 

Factors3

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
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

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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 1.0 chips are not likely to exceed the established RAC tolerance. 

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 postemergence 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. 
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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

Chronic (non-cancer) 24.14 0.5

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-FCIDTM Program and Consumption Information

The fluopicolide chronic dietary exposure and risk assessment was conducted using the DEEMFCIDTM, 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 
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

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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 individualby-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/FQP

A 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=2

0 

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. 
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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

PAD1

(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. 
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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
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

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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.
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

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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
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

Page 12 of 16

 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
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

Page 13 of 16

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 
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

Page 14 of 16

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
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

Page 15 of 16

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%

-------------------------------------------------------------------------------
Fluopicolide Aggregate Dietary Exposure Assessment DP No. D417355

Page 16 of 16

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%

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