Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

Date: 21-MAY-2012

Subject: Fludioxonil. Acute and Chronic Aggregate Dietary (Food and Drinking Water) 

Exposure and Risk Assessment for Uses on Ginseng, Leafy Petioles Crop Subgroup 

4B, Pineapple (post-harvest treatment), Tuberous and Corm Vegetable Subgroup 1C, 

Tropical Fruit (post-harvest treatment), Bulb Onion Subgroup 3-07A, Green Onion 

subgroup 3-07B, Caneberry Subgroup 13-07A, Bushberry Subgroup 13-07B, Small 

Fruit Vine Climbing Subgroup 13-07F (except fuzzy kiwifruit), Low-Growing Berry

Subgroup 13-07G (except cranberry), Fruiting Vegetable Group 8-10 (except 

tomato), Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Leafy Vegetable (except 

Brassica) Subgroup 4A, Dragon Fruit, and Tomato (post-harvest treatment). 

PC Code: 071503 DP Barcode: D389981

Decision Nos.: 447549, 448805 Registration Nos.: 100-953, 100-1242, 100-969, 

100-1308

Petition Nos.: 1E7853, 1E7870 Regulatory Action: Section 3 Registration

Risk Assessment Type: Dietary Case No.: 7017

TXR No.: NA CAS No.: 131341-86-1

MRID No.: None 40 CFR: §180.516

REVIEWER:George F. Kramer, Ph.D., Senior Chemist

Risk Assessment Branch 1 (RAB1)

Health Effects Division (HED, 7509P)

THROUGH: Mohsen Sahafeyan, Chemist

Julie Van Alstine, MPH, Environmental Health Scientist

Dietary Exposure Science Advisory Council (DESAC)

and

David E. Hrdy, Acting Branch Chief

RAB1/HED (7509P)

TO: Barbara Madden/Laura Nollen, RM 05

Mary Waller/Lisa Jones, RM 21

Registration Division (RD, 7505P)

Executive Summary

Acute and chronic dietary (food plus water) exposure and risk assessments were conducted using the 

Dietary Exposure Evaluation Model (DEEM-FCIDTM, Version 2.03) which uses food consumption 

data from the U.S. Department of Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Individuals (CSFII) from 1994-1996 and 1998. These analyses were performed to support the 

proposed Section 3 uses of fludioxonil on ginseng, leaf petioles, pineapple (post-harvest treatment), 

potato (post-harvest treatment), spinach, tropical fruit (post-harvest treatment), bulb onion, green 

onion, caneberry, bushberry, small fruit vine climbing (except fuzzy kiwifruit), low-growing berry

(except cranberry), fruiting vegetables, citrus fruit, pome fruit, leafy vegetables (except Brassica), 

dragon fruit, and tomato (post-harvest treatment).

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

An unrefined acute dietary exposure and risk analysis was performed assuming tolerance-level 

residues, 100% crop-treated (CT), and DEEMTM (ver. 7.81) default processing factors. The 1-in10-year acute drinking water estimate (i.e., relevant to acute exposure) of 0.0838 ppm, 

previously provided by Environmental Fate and Effects Division (EFED), was directly 

incorporated into the acute assessment. This analysis was performed for the population subgroup 

females 13 to 49 years old; the only subgroup of interest for acute exposure. The acute dietary

(food plus water) risk utilizes 16% of acute population-adjusted dose (aPAD) for females 13 to 

49 years old.

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

A partially refined chronic dietary exposure and risk assessment was performed assuming 

tolerance-level residues for most commodities [with the exception of celery, pineapple, potato, 

spinach, apple, grapefruit, lemon, lime, orange, pear, tomato, head lettuce, leaf lettuce, fresh 

parsley, Brassica leafy vegetables (crop group 5), grape, cherry, peach and plum], 100% CT 

estimates, and DEEMTM (ver. 7.81) default processing factors [with the exception of citrus fruit 

juices (1X), apple juice (1X), grape juice (0.42X), raisin (1.65X), potato commodities (1X), and 

tomato commodities (1X), except dried tomato (14.3X)]. These processing factors are based 

upon processing study data. Anticipated residue estimates (ARs) for celery, pineapple, potato, 

spinach, apple, grapefruit, lemon, lime, orange, pear, tomato, head lettuce, leaf lettuce, fresh 

parsley, Brassica leafy vegetables (crop group 5), grape, cherry, peach, and plum were generated 

from field trial and processing study data. The 1-in-10-year chronic drinking water estimate (i.e., 

relevant to chronic exposure) of 0.0385 ppm, provided by the EFED, was directly incorporated 

into the chronic assessment. For the U.S. population the dietary risk (food plus water) utilizes 

26% of the chronic PAD (cPAD). The chronic dietary risk estimate for the highest reported 

exposed population subgroup, children 1 to 2 years old, utilizes 68% of the cPAD. 

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

Fludioxonil is classified as a Group D chemical - not classifiable as to human carcinogenicity; 

therefore, a cancer dietary exposure and risk assessment was not performed for fludioxonil. 

I. Introduction

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

and chronic assessments, the risks are expressed as a percentage of a maximum acceptable dose. 

This is the PAD, which HED has concluded will result in no unreasonable adverse health effects. 

The PAD is equivalent to the point of departure (POD; e.g., NOAEL, LOAEL) divided by the 

required uncertainty or safety factors. Dietary risk is expressed as a percentage of the PAD.
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For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

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

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

Exposure from Pesticides, A User’s Guide”, 21/06/2000, web link: 

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

(08/20/1999).

The most recent dietary risk assessment for fludioxonil was conducted by D. Rate (DP#379936, 

07/14/2010).

II. Residue Information

Established Tolerances: Permanent tolerances for residues of fludioxonil are listed in 40 CFR 

§180.516 and are expressed in terms of fludioxonil (4-(2, 2-difluoro-1, 3-benzodioxol-4-yl)-1H–

pyrrole-3-carbonitrile) in/on a variety of plant commodities. 

Residue of Concern: The HED Metabolism Assessment Review Committee (MARC) has 

determined that the residue of concern for purposes of tolerance enforcement and risk 

assessment, is the parent fludioxonil (DP#262022, W. Donovan et al., 01/18/2000). As part of a 

previous tolerance petition memo, an additional reviewed plant metabolism study reconfirmed 

fludioxonil as the only residue of concern (DP#287808, T. Bloem, 02/12/2003). The nature of 

the residues in livestock is also understood based on the adequate goat and hen metabolism 

studies. For purposes of tolerance enforcement and risk assessment, the residues of concern in 

ruminants are fludioxonil and Metabolite B-1, and the residues of concern in poultry are 

fludioxonil, CGA-344623, and Metabolite I-1.

Recommended Tolerances: As part of the current petition, HED recommends establishing the 

following tolerances: 

CFR §180.516 (a) General. (1) should be as follows: “Tolerances are established for residues of 

the fungicide fludioxonil, including its metabolites and degradates, in or on the commodities in 

the table below. Compliance with the tolerance levels specified below is to be determined by 

measuring only fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile).”

Guava 5.0 ppm

Feijoa 5.0 ppm

Jaboticaba 5.0 ppm

Wax jambu 5.0 ppm

Starfruit 5.0 ppm

Passionfruit 5.0 ppm 

Acerola 5.0 ppm

Avocado 5.0 ppm

Black sapote 5.0 ppm

Mamey sapote 5.0 ppm

Canistel 5.0 ppm

Mango 5.0 ppm

Papaya 5.0 ppm

Sapodilla 5.0 ppm

Star apple 5.0 ppm

Lychee 20 ppm
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Longan 20 ppm

Spanish lime 20 ppm

Rambutan 20 ppm

Pulasan 20 ppm

Sugar apple 20 ppm

Atemoya 20 ppm

Custard apple 20 ppm

Cherimoya 20 ppm

Ilama 20 ppm

Soursop 20 ppm

Biriba 20 ppm

Ginseng 4.0 ppm

Onion, bulb subgroup 3-07A 0.50 ppm

Onion, green subgroup 3-07B 7.0 ppm

Caneberry subgroup 13-07A 5.0 ppm 

Bushberry subgroup 13-07B 2.0 ppm

Fruit, small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit 2.0 ppm

Low growing berry subgroup 13-07G, except cranberry 3.0 ppm

Vegetable, fruiting group 8-10, except tomato 0.50 ppm

Tomato 5.0 ppm

Fruit, citrus, group 10-10 10 ppm

Fruit, pome, group 11-10 5.0 ppm

Vegetable, Leafy, except Brassica, subgroup 4A 30 ppm

Vegetable, tuberous and corm, subgroup 1C 6.0 ppm

Pineapple 20 ppm

Dragon fruit 1.0 ppm

Leafy petioles crop subgroup 4B 15 ppm

The residue definition for the tolerance expression for CFR §180.516 (a) General. (2) should be 

as follows: “Tolerances are established for residues of the fungicide fludioxonil, including its 

metabolites and degradates, in or on the commodities in the table below. Compliance with the 

tolerance levels specified below is to be determined by measuring only the sum of fludioxonil, 4-

(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile), and its metabolites converted to 

2,2-difluoro-l,3-benzodioxole-4-carboxylic acid, calculated as the stoichiometric equivalent of 

fludioxonil.”

Milk 0.01 ppm

Cattle, meat byproducts 0.05 ppm

Cattle, meat 0.01 ppm

Cattle, fat 0.05 ppm

Goat, meat byproducts 0.05 ppm

Goat, meat 0.01 ppm

Goat, fat 0.05 ppm

Horse, meat byproducts 0.05 ppm

Horse, meat 0.01 ppm

Horse, fat 0.05 ppm

Sheep, meat byproducts 0.05 ppm

Sheep, meat 0.01 ppm

Sheep, fat 0.05 ppm

No new data were submitted to support tolerances on onion, bulb, subgroup 3-07A; onion, green, 

subgroup 3-07B; low-growing berry 13-07G crop subgroup; caneberry subgroup 13A; bushberry

subgroup 13B; fruit, citrus, group 10; fruit, pome, group 11-10; or small fruit vine climbing 

subgroup 13-07F, except fuzzy kiwifruit. The petitioner has requested that existing tolerances be 

expanded to their respective crop groups or crop subgroups.
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Residue Data Used for Acute and Chronic Assessments: 

Established and recommended tolerance-level residues, 100% CT, and DEEMTM (ver. 7.81) 

default processing factors were utilized for the acute assessment. 

The chronic assessment was based on the assumption of tolerance-level residues for most 

commodities and 100% CT. ARs for apple, grapefruit, lemon, lime, orange, pear, head lettuce 

(with wrapper), leaf lettuce, fresh parsley, Brassica leafy vegetables (crop group 5), grape, 

cherry, peach, and plum were previously generated from field trial data (D. Rate, DP#379936, 

07/14/2010). ARs for tomato, celery, pineapple, potato, and spinach were also generated from 

field trial data for this assessment, see Table 1, below. For Brassica leafy vegetables (crop group 

5), the field trial data were translated from the representative commodities in the crop groups to 

the non-representative commodities according to HED SOP 2000.1: “Guidance for Translation 

of Field Trial Data from Representative Commodities in the Crop Group Regulation to Other 

Commodities in Each Crop Group/Subgroup.” ARs were determined for apple, grapefruit, 

lemon, and lime juices (J. Sullivan and M. Papathakis, 02/27/2004) using average residues from 

field trials and processing studies. As a result, processing factors were set to 1X for these juices. 

The value for orange juice was set to 0.0 ppm as fungicide-treated fruit are not processed and 

Pesticide Data Program (PDP) monitoring data reported no detectable residues in orange juice 

(16th Annual Summary, data from calendar year 2006). The submitted grape processing study 

indicated that fludioxonil residues do not concentrate in juice or appreciably in raisin. The 

processing factors were set to 0.42X for grape juice and 1.65X for raisin. The submitted tomato,

pineapple, and potato processing study indicated that fludioxonil residues do not appreciably 

concentrate in processed commodities made from treated tomato, pineapple, and potato samples; 

therefore, separate tolerances are not required for tomato, pineapple, and potato processed 

commodities. Processing factors were set to 1X for these processed commodities (pineapple

juice; tomato paste, juice, and puree; and potato chips, flakes, and flour). DEEMTM (ver. 7.81)

default processing factors were used for all other processed commodities for which they are 

available.

Table 1. AR Values Used for the Chronic Assessment.

Commodity AR (ppm)2

Apple, whole

 juice

1.1

0.1

Grapefruit, whole

 juice

2.6

0.74

Lemon, whole

 juice

1.7

0.02

Lime, whole

 juice

1.7

0.02

Orange1, whole

 juice

1.5

0.0

Pear, whole 1.6

Tomato 0.89

Lettuce, head (with wrapper leaves) 2.09

Lettuce, leaf 10.77

Parsley, fresh 1.23

Brassica leafy vegetables (crop 

group 5)

 Cabbage

 Mustard greens

 Broccoli

0.34

1.03

0.13
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Table 1. AR Values Used for the Chronic Assessment.

Commodity AR (ppm)2

Grape 0.33

Cherry 0.82

Peach 0.40

Plum 0.51

Celery 4.9

Pineapple 5.64

Potato 1.82

Spinach 7.1

 

1 Also represents tangerine.

 

2 ARs calculated for the current memo were taken from field trial data associated with the following

 MRID Nos.: 48478501, 48437302, 48437101, 48437305, and 48438204.

III. Drinking Water Data

Estimated drinking water concentrations (EDWCs) were generated using EFED’s standard suite 

of models (DP#389616, C. Sutton, 10/27/2011). The Pesticide Root Zone Model (PRZM, 

v3.12.2, May 2005) and Exposure Analysis Modeling System (EXAMS, v2.98.4.6, April 2005) 

are simulation models used to generate EDWCs of fludioxonil residues that may occur in surface 

water used as drinking water. The PRZM model simulates pesticide movement and 

transformation on and across the agricultural field resulting from crop applications. Percentcropped areas (PCA) that account for the maximum area within a watershed that may be planted 

with the modeled crop are applied to concentrations predicted by PRZM/EXAMS. The models 

and their descriptions are available at the EPA internet site: 

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

Screening Concentration in Ground Water (SCI-GROW v2.3, Jul. 29, 2003) is a regression 

model used as a screening tool to estimate pesticide concentrations found in groundwater used as 

drinking water. The output of SCI-GROW represents the concentrations of fludioxonil that 

might be expected in shallow unconfined aquifers under sandy soils, which is representative of 

the groundwater most vulnerable to pesticide contamination and likely to serve as a drinking 

water source. 

The maximum proposed application rate among all new proposed uses (for onion subgroups 3-

07A and 3-07A) is 0.25 lbs ai/A/application, applied four times per year with a 7-day application 

interval, for a maximum total annual application rate of 1.0 lb ai/A/yr. Because the maximum 

proposed application rate among all of the uses considered for this assessment is less than the 

rates previously assessed by EFED for ornamentals, the EDWCs based on use on ornamentals 

are recommended for use in the human-health dietary assessment. However, based on 

information provided in Syngenta’s 9/9/2011 submission “Fludioxonil Registration Review 

Public Comments Response to Initial 60-Day Comment Period, Case Number: 7017, Docket 

Number: EPA-HQ-OPP-2010-1067,” EFED concurs that the use of the container-grown

ornamentals application rate is not appropriate for estimating EDWCs. As noted by the 

registrant, the strong adsorption of the pesticide to the potting media used for container-grown 

ornamentals, as well as the use of containers, results in attenuation of pesticide movement from 

the containers to the underlying soil in the field, thereby reducing potential runoff of the 

pesticide. Thus, EFED now recommends that the values from the Tier I DWA of 6/22/2009 

(D364264) be used in HED’s human dietary health assessment. The values in the Tier I DWA 

are based on the use of fludioxonil on field-grown ornamentals at one application of 2 lb ai/A/yr. 
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The resulting acute and chronic EDWCs in surface water were 83.8 ppb (1-in-10-year acute 

estimate) and 38.5 ppb (1-in-10-year chronic estimate), respectively. The EDWC for 

groundwater (for both acute and chronic analysis) is 0.2 ppb. Since the surface water 

concentrations were the highest; the acute and chronic dietary runs were conducted assuming 

water residues of 0.0838 ppm and 0.0385 ppm, respectively, for all water sources (direct and 

indirect). 

Table 2. Tier II Estimated Drinking Water Concentrations (EDWCs) Resulting From Applications of 

Fludioxonil on Ornamentals (Total Rate of 4 lb ai/A/yr).

Drinking water source 

(model) Use

1-in-10-year acute 

(μg/L)

1-in-10-year chronic 

(μg/L)

Surface water 

(PRZM/EXAMS)

Container-grown 

ornamental 83.8 38.5

Groundwater (SCI-GROW) Container-grown 

ornamental 0.2 0.2

IV. DEEM-FCIDTM Program and Consumption Information

Fludioxonil acute and chronic dietary exposure assessments were conducted using the DEEMFCIDTM model, Version 2.03, which incorporates consumption data from USDA’s CSFII, 1994-

1996 and 1998. The 1994-96, 98 data are based on the reported consumption of more than 

20,000 individuals over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) 

are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; 

baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation 

files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption 

data are averaged for the entire U.S. population and within population subgroups, but for acute 

exposure assessment are retained as individual consumption events. Based on analysis of the 

1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey

respondents, HED concluded that it is most appropriate to report risk for the following 

population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, 

children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

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

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

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

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

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

of the cPAD. This procedure is performed for each population subgroup.

For 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 
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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.

V. Toxicological Information

The HED Hazard Identification Assessment Review Committee (HIARC) previously reviewed 

the fludioxonil toxicological database (HED Doc. No. 013806, W. Dykstra, 10/13/1999; TXR 

No. 0050427, W. Dykstra, 01/29/2002) and concluded that the 10X safety factor should be 

reduced to 1X. The most recent review of the toxicology database (DP#389613, G. Kramer et 

al., 05/21/2012) showed that the database is essentially complete and there is no evidence of 

neurotoxicity or immunotoxicity in the hazard database for fludioxonil. While the new Part 158 

requirements for an immunotoxicity study and acute and subchronic neurotoxicity studies have 

not yet been fulfilled for fludioxonil, the existing data are sufficient for endpoint selection for 

exposure/risk assessment scenarios and for evaluation of the requirements under the Food 

Quality Protection Act (FQPA). The toxicological endpoints used for dietary exposure for 

fludioxonil are summarized in Table 3, below. 

Table 3. Summary of Toxicological Doses and Endpoints for Fludioxonil for Use in Dietary Exposure Risk 

Assessments.

Exposure/

Scenario

Point of 

Departure

Uncertainty/FQPA 

Safety Factors RfD, PAD Study and Toxicological Effects

Acute Dietary 

(General 

Population, 

including 

Infants and 

Children)

There were no appropriate toxicological effects attributable to a single exposure (dose) observed in 

available oral toxicity studies, including maternal toxicity in the developmental toxicity studies. 

Therefore, a dose and endpoint were not identified for this risk assessment.

Acute Dietary

(Females 13-

49 years of 

age)

NOAEL = 

100 

mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 1X

Acute RfD = 1.0 

mg/kg/day

aPAD = 1.0 

mg/kg/day

Rat developmental study. 

LOAEL = 1000 mg/kg/day based 

on an increased incidence of 

fetuses and litters with dilated 

renal pelvis and dilated ureter in 

rat developmental study.

Chronic 

Dietary (All 

Populations)

NOAEL= 

3.3

mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 1X

Chronic RfD = 0.033

mg/kg/day

cPAD = 0.033

mg/kg/day

One-year dog feeding study. 

LOAEL = 35.5 mg/kg/day based 

on based on decreased weight gain 

in female dogs during weeks 1-52.

Cancer (oral, dermal, 

inhalation) 

Classification: HED’s Cancer Peer Review Committee has classified fludioxonil as 

a Group D chemical - not classifiable as to human carcinogenicity. 

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 (intraspecies). UFH = potential variation in 

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

population-adjusted dose (a = acute, c = chronic). RfD = reference dose. N/A = not applicable.
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VI. Results/Discussion

For acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the 

PAD. The DEEM-FCIDTM analyses estimate the dietary exposure of the U.S. population and 

various population subgroups. The results reported in the Summary Table (Table 4) 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 and Chronic Dietary Exposure Analyses

The acute dietary risk for fludioxonil at the 95th percentile of exposure (food plus water) utilizes 

16% of the aPAD for females 13 to 49 years old. There were no appropriate toxicological effects 

attributable to a single exposure (dose) for the general population or any other population 

subgroups; therefore, these population subgroups were not included in this assessment.

The chronic dietary risk for the U.S. population (food plus water) for fludioxonil utilizes 26% of 

the cPAD. The chronic dietary risk for the highest exposed population subgroup, children 1-2 

years old, is 68% of the cPAD.

The results of the acute and chronic dietary exposure and risk analyses are reported in the 

Summary Table (Table 4, below). 

Table 4. Summary of Dietary Exposure (Food Plus Water) and Risk Assessment for Fludioxonil.

Population Subgroup

Acute Dietary

(95th Percentile) Chronic Dietary

Dietary 

Exposure 

(mg/kg/day) % aPAD*

Dietary 

Exposure

(mg/kg/day) % cPAD*

General U.S. Population

N/A

0.008711 26

All Infants (<1 year old) 0.018891 57

Children 1-2 years old 0.022497 68

Children 3-5 years old 0.017817 54

Children 6-12 years old 0.011011 33

Youth 13-19 years old 0.006547 20

Adults 20-49 years old 0.006943 21

Adults 50+ years old 0.007778 24

Females 13-49 years old 0.164096 16 0.007073 21

* % PADs are reported to 2 significant figures. The values for the highest exposed population for each type of risk 

assessment are bolded.

VII. Characterization of Inputs/Outputs

These analyses are conservative dietary exposure assessments. Further refinement to the 

analyses could be made through the use of additional ARs, incorporation of percent CT 

estimates, and/or monitoring data that better reflect residues at the time of consumption. 

The acute dietary exposure and risk assessment incorporated tolerance-level residues (established 

and recommended), 100% CT, and DEEMTM (ver. 7.81) default processing factors. The 1-in-10-

year acute drinking water estimate (i.e., relevant to acute exposure) of 0.0838 ppm was directly 

incorporated into the acute assessment. 
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A partially refined chronic dietary exposure and risk assessment was performed assuming 

tolerance-level residues for most commodities [with the exception of celery, pineapple, potato, 

spinach, apple, grapefruit, lemon, lime, orange, pear, tomato, head lettuce, leaf lettuce, fresh 

parsley, Brassica leafy vegetables (crop group 5), grape, cherry, peach and plum], 100% CT 

estimates, and DEEMTM (ver. 7.81) default processing factors [with the exception of citrus fruit 

juice (1X), apple juice (1X), grape juice (0.42X), raisin (1.65X), potato commodities (1X), and 

tomato commodities (1X), except dried tomato (14.3X)]. These processing factors are based 

upon processing study data. ARs for celery, pineapple, potato, spinach, apple, grapefruit, lemon, 

lime, orange, pear, tomato, head lettuce, leaf lettuce, fresh parsley, Brassica leafy vegetables 

(crop group 5), grape, cherry, peach, and plum were generated from field trial and processing 

study data for the chronic analysis. The 1-in-10-year chronic drinking water estimate (i.e., 

relevant to chronic exposure) of 0.0385 ppm, provided by the EFED, was directly incorporated 

into the chronic assessment.

HED concludes that the exposure estimates provided in this document are unlikely to 

underestimate actual exposure for the following reasons: (1) the analysis incorporated tolerancelevel residues or made use of average residues derived from crop field trial studies (maximum 

application rate and minimum pre-harvest interval); and (2) the surface drinking water estimates 

were from a conservative drinking water assessment and are based upon the maximum use rate

pattern on the label. 

VIII. Conclusions

Acute and chronic dietary (food plus drinking water) dietary exposure and risk assessment 

assessments were conducted for fludioxonil to support the proposed Section 3 uses of fludioxonil 

on ginseng, leaf petioles, pineapple (post-harvest treatment), potato (post-harvest treatment), 

spinach, tropical fruit (post-harvest treatment), bulb onion, green onion, caneberry, bushberry, 

small fruit vine climbing (except fuzzy kiwifruit), low-growing berry (except cranberry), fruiting 

vegetables, citrus fruit, pome fruit, leafy vegetables (except Brassica), dragon fruit, and tomato 

(post-harvest treatment). The acute dietary (food plus drinking water) exposure to fludioxonil is 

below HED’s level of concern for females 13 to 49 years old (the only subgroup of interest). 

The acute dietary risk utilizes 16% of the aPAD at the 95thpercentile for females 13-49 years 

old. The chronic dietary (food plus drinking water) exposure to fludioxonil is below HED’s

level of concern for the general U.S. population and all population subgroups. The chronic 

dietary risk utilizes 26% of the cPAD for the general U.S. population; and, for the most highly 

exposed population subgroup (children 1-2 years old) 68% of the cPAD. 

IX. List of Attachments

Attachment 1: DEEM-FCIDTM Acute Residue File

Attachment 2: DEEM-FCIDTM Acute Exposure and Risk Estimates

Attachment 3: DEEM-FCIDTM Chronic Residue File

Attachment 4: DEEM-FCIDTM Chronic Exposure and Risk Estimates

cc: G. Kramer

G.F. Kramer:S10957:PY-S:(703)305-5079:7509P:RAB1
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 11 of 25

Attachment 1: DEEM-FCIDTM Acute Residue File

Filename: C:\Documents and Settings\gkramer\My Documents\Gk\##Fludioxonil\2012_071503a.R98

Chemical: Fludioxonil

RfD(Chronic): .03 mg/kg bw/day NOEL(Chronic): 3.3 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 100 mg/kg bw/day

Date created/last modified: 05-17-2012/13:28:47/8 Program ver. 2.03

Comment: DPR Work-share Acute/Chronic Dietary with new FY04 Section 3 Tolerances

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

01010500 1AB Beet, garden, roots 0.750000 1.000 1.000 

01010501 1AB Beet, garden, roots-babyfood 0.750000 1.000 1.000 

01010520 1A Beet, sugar 0.020000 1.000 1.000 

01010521 1A Beet, sugar-babyfood 0.020000 1.000 1.000 

01010530 1A Beet, sugar, molasses 0.020000 1.000 1.000 

01010531 1A Beet, sugar, molasses-babyfood 0.020000 1.000 1.000 

01010670 1AB Burdock 0.750000 1.000 1.000 

01010780 1AB Carrot 0.750000 1.000 1.000 

01010781 1AB Carrot-babyfood 0.750000 1.000 1.000 

01010790 1AB Carrot, juice 0.750000 1.000 1.000 

01010840 1AB Celeriac 0.750000 1.000 1.000 

01011000 1AB Chicory, roots 0.750000 1.000 1.000 

01011680 1AB Ginseng, dried 4.000000 1.000 1.000 

01011900 1AB Horseradish 0.750000 1.000 1.000 

01012500 1AB Parsley, turnip rooted 0.750000 1.000 1.000 

01012510 1AB Parsnip 0.750000 1.000 1.000 

01012511 1AB Parsnip-babyfood 0.750000 1.000 1.000 

01013140 1AB Radish, roots 0.750000 1.000 1.000 

01013160 1AB Radish, Oriental, roots 0.750000 1.000 1.000 

01013270 1AB Rutabaga 0.750000 1.000 1.000 

01013310 1AB Salsify, roots 0.750000 1.000 1.000 

01013880 1AB Turnip, roots 0.750000 1.000 1.000 

01030150 1CD Arrowroot, flour 6.000000 1.000 1.000 

01030151 1CD Arrowroot, flour-babyfood 6.000000 1.000 1.000 

01030170 1CD Artichoke, Jerusalem 6.000000 1.000 1.000 

01030820 1CD Cassava 6.000000 1.000 1.000 

01030821 1CD Cassava-babyfood 6.000000 1.000 1.000 

01031390 1CD Dasheen, corm 6.000000 1.000 1.000 

01031660 1CD Ginger 6.000000 1.000 1.000 

01031661 1CD Ginger-babyfood 6.000000 1.000 1.000 

01031670 1CD Ginger, dried 6.000000 1.000 1.000 

01032960 1C Potato, chips 6.000000 1.000 1.000 

01032970 1C Potato, dry (granules/ flakes) 6.000000 6.500 1.000 

01032971 1C Potato, dry (granules/ flakes)-b 6.000000 6.500 1.000 

01032980 1C Potato, flour 6.000000 6.500 1.000 

01032981 1C Potato, flour-babyfood 6.000000 6.500 1.000 

01032990 1C Potato, tuber, w/peel 6.000000 1.000 1.000 

01032991 1C Potato, tuber, w/peel-babyfood 6.000000 1.000 1.000 

01033000 1C Potato, tuber, w/o peel 6.000000 1.000 1.000 

01033001 1C Potato, tuber, w/o peel-babyfood 6.000000 1.000 1.000 

01033660 1CD Sweet potato 6.000000 1.000 1.000 

01033661 1CD Sweet potato-babyfood 6.000000 1.000 1.000 

01033710 1CD Tanier, corm 6.000000 1.000 1.000 

01033870 1CD Turmeric 6.000000 1.000 1.000 

01034060 1CD Yam, true 8.000000 1.000 1.000 

01034070 1CD Yam bean 6.000000 1.000 1.000 

02000510 2 Beet, garden, tops 30.000000 1.000 1.000 

02001010 2 Chicory, tops 30.000000 1.000 1.000 

02001400 2 Dasheen, leaves 30.000000 1.000 1.000 

02003150 2 Radish, tops 30.000000 1.000 1.000 

02003170 2 Radish, Oriental, tops 30.000000 1.000 1.000 

02003320 2 Salsify, tops 30.000000 1.000 1.000 

03001640 3 Garlic 0.500000 1.000 1.000 

03001650 3 Garlic, dried 0.500000 1.000 1.000 

03001651 3 Garlic, dried-babyfood 0.500000 1.000 1.000 

03001980 3 Leek 7.000000 1.000 1.000 

03002370 3 Onion, dry bulb 0.500000 1.000 1.000 

03002371 3 Onion, dry bulb-babyfood 0.500000 1.000 1.000 

03002380 3 Onion, dry bulb, dried 0.500000 9.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 12 of 25

03002381 3 Onion, dry bulb, dried-babyfood 0.500000 9.000 1.000 

03002390 3 Onion, green 7.000000 1.000 1.000 

03003380 3 Shallot 0.500000 1.000 1.000 

04010050 4A Amaranth, leafy 30.000000 1.000 1.000 

04010180 4A Arugula 30.000000 1.000 1.000 

04011040 4A Chrysanthemum, garland 30.000000 1.000 1.000 

04011330 4A Cress, garden 30.000000 1.000 1.000 

04011340 4A Cress, upland 30.000000 1.000 1.000 

04011380 4A Dandelion, leaves 30.000000 1.000 1.000 

04011500 4A Endive 30.000000 1.000 1.000 

04012040 4A Lettuce, head 30.000000 1.000 1.000 

04012050 4A Lettuce, leaf 30.000000 1.000 1.000 

04012480 4A Parsley, leaves 30.000000 1.000 1.000 

04013130 4A Radicchio 30.000000 1.000 1.000 

04013550 4A Spinach 30.000000 1.000 1.000 

04013551 4A Spinach-babyfood 30.000000 1.000 1.000 

04020760 4B Cardoon 15.000000 1.000 1.000 

04020850 4B Celery 15.000000 1.000 1.000 

04020851 4B Celery-babyfood 15.000000 1.000 1.000 

04020860 4B Celery, juice 15.000000 1.000 1.000 

04020870 4B Celtuce 15.000000 1.000 1.000 

04021520 4B Fennel, Florence 15.000000 1.000 1.000 

04023220 4B Rhubarb 15.000000 1.000 1.000 

04023670 4B Swiss chard 15.000000 1.000 1.000 

05010610 5A Broccoli 2.000000 1.000 1.000 

05010611 5A Broccoli-babyfood 2.000000 1.000 1.000 

05010620 5A Broccoli, Chinese 2.000000 1.000 1.000 

05010640 5A Brussels sprouts 2.000000 1.000 1.000 

05010690 5A Cabbage 2.000000 1.000 1.000 

05010710 5A Cabbage, Chinese, napa 2.000000 1.000 1.000 

05010720 5A Cabbage, Chinese, mustard 2.000000 1.000 1.000 

05010830 5A Cauliflower 2.000000 1.000 1.000 

05011960 5A Kohlrabi 2.000000 1.000 1.000 

05020630 5B Broccoli raab 10.000000 1.000 1.000 

05020700 5B Cabbage, Chinese, bok choy 10.000000 1.000 1.000 

05021170 5B Collards 10.000000 1.000 1.000 

05021940 5B Kale 10.000000 1.000 1.000 

05022290 5B Mustard greens 10.000000 1.000 1.000 

05023180 5B Rape greens 10.000000 1.000 1.000 

05023890 5B Turnip, greens 10.000000 1.000 1.000 

06003470 6 Soybean, seed 0.010000 1.000 1.000 

06003480 6 Soybean, flour 0.010000 1.000 1.000 

06003481 6 Soybean, flour-babyfood 0.010000 1.000 1.000 

06003490 6 Soybean, soy milk 0.010000 1.000 1.000 

06003491 6 Soybean, soy milk-babyfood or in 0.010000 1.000 1.000 

06003500 6 Soybean, oil 0.010000 1.000 1.000 

06003501 6 Soybean, oil-babyfood 0.010000 1.000 1.000 

06010430 6A Bean, snap, succulent 0.400000 1.000 1.000 

06010431 6A Bean, snap, succulent-babyfood 0.400000 1.000 1.000 

06012570 6A Pea, edible podded, succulent 0.010000 1.000 1.000 

06020310 6B Bean, broad, succulent 0.400000 1.000 1.000 

06020330 6B Bean, cowpea, succulent 0.400000 1.000 1.000 

06020370 6B Bean, lima, succulent 0.400000 1.000 1.000 

06022550 6B Pea, succulent 0.010000 1.000 1.000 

06022551 6B Pea, succulent-babyfood 0.010000 1.000 1.000 

06022590 6B Pea, pigeon, succulent 0.010000 1.000 1.000 

06030300 6C Bean, black, seed 0.400000 1.000 1.000 

06030320 6C Bean, broad, seed 0.400000 1.000 1.000 

06030340 6C Bean, cowpea, seed 0.400000 1.000 1.000 

06030350 6C Bean, great northern, seed 0.400000 1.000 1.000 

06030360 6C Bean, kidney, seed 0.400000 1.000 1.000 

06030380 6C Bean, lima, seed 0.400000 1.000 1.000 

06030390 6C Bean, mung, seed 0.400000 1.000 1.000 

06030400 6C Bean, navy, seed 0.400000 1.000 1.000 

06030410 6C Bean, pink, seed 0.400000 1.000 1.000 

06030420 6C Bean, pinto, seed 0.400000 1.000 1.000 

06030980 6C Chickpea, seed 0.400000 1.000 1.000 

06030981 6C Chickpea, seed-babyfood 0.400000 1.000 1.000 

06030990 6C Chickpea, flour 0.400000 1.000 1.000 

06031820 6C Guar, seed 0.400000 1.000 1.000 

06031821 6C Guar, seed-babyfood 0.400000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 13 of 25

06032030 6C Lentil, seed 0.400000 1.000 1.000 

06032560 6C Pea, dry 0.010000 1.000 1.000 

06032561 6C Pea, dry-babyfood 0.010000 1.000 1.000 

06032580 6C Pea, pigeon, seed 0.010000 1.000 1.000 

08001480 8 Eggplant 0.500000 1.000 1.000 

08002340 8 Okra 0.500000 1.000 1.000 

08002700 8 Pepper, bell 0.500000 1.000 1.000 

08002701 8 Pepper, bell-babyfood 0.500000 1.000 1.000 

08002710 8 Pepper, bell, dried 0.500000 1.000 1.000 

08002711 8 Pepper, bell, dried-babyfood 0.500000 1.000 1.000 

08002720 8 Pepper, nonbell 0.500000 1.000 1.000 

08002721 8 Pepper, nonbell-babyfood 0.500000 1.000 1.000 

08002730 8 Pepper, nonbell, dried 0.500000 1.000 1.000 

08003740 8 Tomatillo 0.500000 1.000 1.000 

08003750 8 Tomato 5.000000 1.000 1.000 

08003751 8 Tomato-babyfood 5.000000 1.000 1.000 

08003760 8 Tomato, paste 5.000000 5.400 1.000 

08003761 8 Tomato, paste-babyfood 5.000000 5.400 1.000 

08003770 8 Tomato, puree 5.000000 3.300 1.000 

08003771 8 Tomato, puree-babyfood 5.000000 3.300 1.000 

08003780 8 Tomato, dried 5.000000 14.300 1.000 

08003781 8 Tomato, dried-babyfood 5.000000 14.300 1.000 

08003790 8 Tomato, juice 5.000000 1.500 1.000 

09010750 9A Cantaloupe 0.450000 1.000 1.000 

09010800 9A Casaba 0.450000 1.000 1.000 

09011870 9A Honeydew melon 0.450000 1.000 1.000 

09013990 9A Watermelon 0.450000 1.000 1.000 

09014000 9A Watermelon, juice 0.450000 1.000 1.000 

09020210 9B Balsam pear 0.450000 1.000 1.000 

09020880 9B Chayote, fruit 0.450000 1.000 1.000 

09021020 9B Chinese waxgourd 0.450000 1.000 1.000 

09021350 9B Cucumber 0.450000 1.000 1.000 

09023080 9B Pumpkin 0.450000 1.000 1.000 

09023090 9B Pumpkin, seed 0.450000 1.000 1.000 

09023560 9B Squash, summer 0.450000 1.000 1.000 

09023561 9B Squash, summer-babyfood 0.450000 1.000 1.000 

09023570 9B Squash, winter 0.450000 1.000 1.000 

09023571 9B Squash, winter-babyfood 0.450000 1.000 1.000 

10001060 10 Citrus citron 10.000000 1.000 1.000 

10001070 10 Citrus hybrids 10.000000 1.000 1.000 

10001080 10 Citrus, oil 500.000000 1.000 1.000 

10001800 10 Grapefruit 10.000000 1.000 1.000 

10001810 10 Grapefruit, juice 10.000000 2.100 1.000 

10001970 10 Kumquat 10.000000 1.000 1.000 

10001990 10 Lemon 10.000000 1.000 1.000 

10002000 10 Lemon, juice 10.000000 2.000 1.000 

10002001 10 Lemon, juice-babyfood 10.000000 2.000 1.000 

10002010 10 Lemon, peel 10.000000 1.000 1.000 

10002060 10 Lime 10.000000 1.000 1.000 

10002070 10 Lime, juice 10.000000 2.000 1.000 

10002071 10 Lime, juice-babyfood 10.000000 2.000 1.000 

10002400 10 Orange 10.000000 1.000 1.000 

10002410 10 Orange, juice 10.000000 1.800 1.000 

10002411 10 Orange, juice-babyfood 10.000000 1.800 1.000 

10002420 10 Orange, peel 10.000000 1.000 1.000 

10003070 10 Pummelo 10.000000 1.000 1.000 

10003690 10 Tangerine 10.000000 1.000 1.000 

10003700 10 Tangerine, juice 10.000000 2.300 1.000 

11000070 11 Apple, fruit with peel 5.000000 1.000 1.000 

11000080 11 Apple, peeled fruit 5.000000 1.000 1.000 

11000081 11 Apple, peeled fruit-babyfood 5.000000 1.000 1.000 

11000090 11 Apple, dried 5.000000 8.000 1.000 

11000091 11 Apple, dried-babyfood 5.000000 8.000 1.000 

11000100 11 Apple, juice 5.000000 1.300 1.000 

11000101 11 Apple, juice-babyfood 5.000000 1.300 1.000 

11000110 11 Apple, sauce 5.000000 1.000 1.000 

11000111 11 Apple, sauce-babyfood 5.000000 1.000 1.000 

11001290 11 Crabapple 5.000000 1.000 1.000 

11002100 11 Loquat 5.000000 1.000 1.000 

11002660 11 Pear 5.000000 1.000 1.000 

11002661 11 Pear-babyfood 5.000000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 14 of 25

11002670 11 Pear, dried 5.000000 6.250 1.000 

11002680 11 Pear, juice 5.000000 1.000 1.000 

11002681 11 Pear, juice-babyfood 5.000000 1.000 1.000 

11003100 11 Quince 5.000000 1.000 1.000 

12000120 12 Apricot 5.000000 1.000 1.000 

12000121 12 Apricot-babyfood 5.000000 1.000 1.000 

12000130 12 Apricot, dried 5.000000 6.000 1.000 

12000140 12 Apricot, juice 5.000000 1.000 1.000 

12000141 12 Apricot, juice-babyfood 5.000000 1.000 1.000 

12000900 12 Cherry 5.000000 1.000 1.000 

12000901 12 Cherry-babyfood 5.000000 1.000 1.000 

12000910 12 Cherry, juice 5.000000 1.500 1.000 

12000911 12 Cherry, juice-babyfood 5.000000 1.500 1.000 

12002300 12 Nectarine 5.000000 1.000 1.000 

12002600 12 Peach 5.000000 1.000 1.000 

12002601 12 Peach-babyfood 5.000000 1.000 1.000 

12002610 12 Peach, dried 5.000000 7.000 1.000 

12002611 12 Peach, dried-babyfood 5.000000 7.000 1.000 

12002620 12 Peach, juice 5.000000 1.000 1.000 

12002621 12 Peach, juice-babyfood 5.000000 1.000 1.000 

12002850 12 Plum 5.000000 1.000 1.000 

12002851 12 Plum-babyfood 5.000000 1.000 1.000 

12002860 12 Plum, prune, fresh 5.000000 1.000 1.000 

12002861 12 Plum, prune, fresh-babyfood 5.000000 1.000 1.000 

12002870 12 Plum, prune, dried 5.000000 5.000 1.000 

12002871 12 Plum, prune, dried-babyfood 5.000000 5.000 1.000 

12002880 12 Plum, prune, juice 5.000000 1.400 1.000 

12002881 12 Plum, prune, juice-babyfood 5.000000 1.400 1.000 

13010550 13A Blackberry 5.000000 1.000 1.000 

13010560 13A Blackberry, juice 5.000000 1.000 1.000 

13010561 13A Blackberry, juice-babyfood 5.000000 1.000 1.000 

13010580 13A Boysenberry 5.000000 1.000 1.000 

13011420 13A Dewberry 5.000000 1.000 1.000 

13012080 13A Loganberry 5.000000 1.000 1.000 

13013200 13A Raspberry 5.000000 1.000 1.000 

13013201 13A Raspberry-babyfood 5.000000 1.000 1.000 

13013210 13A Raspberry, juice 5.000000 1.000 1.000 

13013211 13A Raspberry, juice-babyfood 5.000000 1.000 1.000 

13020570 13B Blueberry 3.000000 1.000 1.000 

13020571 13B Blueberry-babyfood 3.000000 1.000 1.000 

13021360 13B Currant 2.000000 1.000 1.000 

13021370 13B Currant, dried 2.000000 1.000 1.000 

13021490 13B Elderberry 2.000000 1.000 1.000 

13021740 13B Gooseberry 2.000000 1.000 1.000 

13021910 13B Huckleberry 2.000000 1.000 1.000 

14002820 14 Pistachio 0.100000 1.000 1.000 

15000250 15 Barley, pearled barley 0.020000 1.000 1.000 

15000251 15 Barley, pearled barley-babyfood 0.020000 1.000 1.000 

15000260 15 Barley, flour 0.020000 1.000 1.000 

15000261 15 Barley, flour-babyfood 0.020000 1.000 1.000 

15000270 15 Barley, bran 0.020000 1.000 1.000 

15000650 15 Buckwheat 0.020000 1.000 1.000 

15000660 15 Buckwheat, flour 0.020000 1.000 1.000 

15001200 15 Corn, field, flour 0.020000 1.000 1.000 

15001201 15 Corn, field, flour-babyfood 0.020000 1.000 1.000 

15001210 15 Corn, field, meal 0.020000 1.000 1.000 

15001211 15 Corn, field, meal-babyfood 0.020000 1.000 1.000 

15001220 15 Corn, field, bran 0.020000 1.000 1.000 

15001230 15 Corn, field, starch 0.020000 1.000 1.000 

15001231 15 Corn, field, starch-babyfood 0.020000 1.000 1.000 

15001240 15 Corn, field, syrup 0.020000 1.500 1.000 

15001241 15 Corn, field, syrup-babyfood 0.020000 1.500 1.000 

15001250 15 Corn, field, oil 0.020000 1.000 1.000 

15001251 15 Corn, field, oil-babyfood 0.020000 1.000 1.000 

15001260 15 Corn, pop 0.020000 1.000 1.000 

15001270 15 Corn, sweet 0.020000 1.000 1.000 

15001271 15 Corn, sweet-babyfood 0.020000 1.000 1.000 

15002260 15 Millet, grain 0.020000 1.000 1.000 

15002310 15 Oat, bran 0.020000 1.000 1.000 

15002320 15 Oat, flour 0.020000 1.000 1.000 

15002321 15 Oat, flour-babyfood 0.020000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 15 of 25

15002330 15 Oat, groats/rolled oats 0.020000 1.000 1.000 

15002331 15 Oat, groats/rolled oats-babyfood 0.020000 1.000 1.000 

15003230 15 Rice, white 0.020000 1.000 1.000 

15003231 15 Rice, white-babyfood 0.020000 1.000 1.000 

15003240 15 Rice, brown 0.020000 1.000 1.000 

15003241 15 Rice, brown-babyfood 0.020000 1.000 1.000 

15003250 15 Rice, flour 0.020000 1.000 1.000 

15003251 15 Rice, flour-babyfood 0.020000 1.000 1.000 

15003260 15 Rice, bran 0.020000 1.000 1.000 

15003261 15 Rice, bran-babyfood 0.020000 1.000 1.000 

15003280 15 Rye, grain 0.020000 1.000 1.000 

15003290 15 Rye, flour 0.020000 1.000 1.000 

15003440 15 Sorghum, grain 0.020000 1.000 1.000 

15003450 15 Sorghum, syrup 0.020000 1.000 1.000 

15003810 15 Triticale, flour 0.020000 1.000 1.000 

15003811 15 Triticale, flour-babyfood 0.020000 1.000 1.000 

15004010 15 Wheat, grain 0.020000 1.000 1.000 

15004011 15 Wheat, grain-babyfood 0.020000 1.000 1.000 

15004020 15 Wheat, flour 0.020000 1.000 1.000 

15004021 15 Wheat, flour-babyfood 0.020000 1.000 1.000 

15004030 15 Wheat, germ 0.020000 1.000 1.000 

15004040 15 Wheat, bran 0.020000 1.000 1.000 

15004050 15 Wild rice 0.020000 1.000 1.000 

19010280 19A Basil, fresh leaves 10.000000 1.000 1.000 

19010281 19A Basil, fresh leaves-babyfood 10.000000 1.000 1.000 

19010290 19A Basil, dried leaves 65.000000 1.000 1.000 

19010291 19A Basil, dried leaves-babyfood 65.000000 1.000 1.000 

19011030 19A Chive 10.000000 1.000 1.000 

19011180 19A Coriander, leaves 10.000000 1.000 1.000 

19011181 19A Coriander, leaves-babyfood 10.000000 1.000 1.000 

19011440 19A Dillweed 10.000000 1.000 1.000 

19011840 19A Herbs, other 65.000000 1.000 1.000 

19011841 19A Herbs, other-babyfood 65.000000 1.000 1.000 

19012020 19A Lemongrass 10.000000 1.000 1.000 

19012200 19A Marjoram 10.000000 1.000 1.000 

19012201 19A Marjoram-babyfood 10.000000 1.000 1.000 

19012490 19A Parsley, dried leaves 65.000000 1.000 1.000 

19012491 19A Parsley, dried leaves-babyfood 65.000000 1.000 1.000 

19013340 19A Savory 10.000000 1.000 1.000 

19021050 19B Cinnamon 0.020000 1.000 1.000 

19021051 19B Cinnamon-babyfood 0.020000 1.000 1.000 

19021190 19B Coriander, seed 0.020000 1.000 1.000 

19021191 19B Coriander, seed-babyfood 0.020000 1.000 1.000 

19021430 19B Dill, seed 0.020000 1.000 1.000 

19022740 19B Pepper, black and white 0.020000 1.000 1.000 

19022741 19B Pepper, black and white-babyfood 0.020000 1.000 1.000 

19023540 19B Spices, other 0.020000 1.000 1.000 

19023541 19B Spices, other-babyfood 0.020000 1.000 1.000 

20001630 20 Flaxseed, oil 0.050000 1.000 1.000 

20003190 20 Rapeseed, oil 0.010000 1.000 1.000 

20003191 20 Rapeseed, oil-babyfood 0.010000 1.000 1.000 

20003300 20 Safflower, oil 0.010000 1.000 1.000 

20003301 20 Safflower, oil-babyfood 0.010000 1.000 1.000 

20003640 20 Sunflower, seed 0.010000 1.000 1.000 

20003650 20 Sunflower, oil 0.010000 1.000 1.000 

20003651 20 Sunflower, oil-babyfood 0.010000 1.000 1.000 

21000440 M Beef, meat 0.010000 1.000 1.000 

21000441 M Beef, meat-babyfood 0.010000 1.000 1.000 

21000450 M Beef, meat, dried 0.010000 1.920 1.000 

21000460 M Beef, meat byproducts 0.050000 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.050000 1.000 1.000 

21000470 M Beef, fat 0.050000 1.000 1.000 

21000471 M Beef,fat-babyfood 0.050000 1.000 1.000 

21000480 M Beef, kidney 0.050000 1.000 1.000 

21000490 M Beef, liver 0.050000 1.000 1.000 

21000491 M Beef, liver-babyfood 0.050000 1.000 1.000 

23001690 M Goat, meat 0.010000 1.000 1.000 

23001700 M Goat, meat byproducts 0.050000 1.000 1.000 

23001710 M Goat, fat 0.050000 1.000 1.000 

23001720 M Goat, kidney 0.050000 1.000 1.000 

23001730 M Goat, liver 0.050000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 16 of 25

24001890 M Horse, meat 0.010000 1.000 1.000 

26003390 M Sheep, meat 0.010000 1.000 1.000 

26003391 M Sheep, meat-babyfood 0.010000 1.000 1.000 

26003400 M Sheep, meat byproducts 0.050000 1.000 1.000 

26003410 M Sheep, fat 0.050000 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.050000 1.000 1.000 

26003420 M Sheep, kidney 0.050000 1.000 1.000 

26003430 M Sheep, liver 0.050000 1.000 1.000 

27002220 D Milk, fat 0.010000 1.000 1.000 

27002221 D Milk, fat - baby food/infant for 0.010000 1.000 1.000 

27012230 D Milk, nonfat solids 0.010000 1.000 1.000 

27012231 D Milk, nonfat solids-baby food/in 0.010000 1.000 1.000 

27022240 D Milk, water 0.010000 1.000 1.000 

27022241 D Milk, water-babyfood/infant form 0.010000 1.000 1.000 

27032251 D Milk, sugar (lactose)-baby food/ 0.010000 1.000 1.000 

86010000 O Water, direct, all sources 0.083800 1.000 1.000 

86020000 O Water, indirect, all sources 0.083800 1.000 1.000 

95000010 O Acerola 5.000000 1.000 1.000 

95000200 O Avocado 5.000000 1.000 1.000 

95000740 O Canistel 5.000000 1.000 1.000 

95000890 O Cherimoya 20.000000 1.000 1.000 

95001280 O Cottonseed, oil 0.050000 1.000 1.000 

95001281 O Cottonseed, oil-babyfood 0.050000 1.000 1.000 

95001510 O Feijoa 5.000000 1.000 1.000 

95001750 O Grape 2.000000 1.000 1.000 

95001760 O Grape, juice 2.000000 1.200 1.000 

95001761 O Grape, juice-babyfood 2.000000 1.200 1.000 

95001770 O Grape, leaves 2.000000 1.000 1.000 

95001780 O Grape, raisin 2.000000 4.300 1.000 

95001790 O Grape, wine and sherry 2.000000 1.000 1.000 

95001830 O Guava 5.000000 1.000 1.000 

95001831 O Guava-babyfood 5.000000 1.000 1.000 

95001920 O Jaboticaba 5.000000 1.000 1.000 

95001950 O Kiwifruit 20.000000 1.000 1.000 

95002090 O Longan 20.000000 1.000 1.000 

95002110 O Lychee 20.000000 1.000 1.000 

95002120 O Lychee, dried 20.000000 1.850 1.000 

95002150 O Mango 5.000000 1.000 1.000 

95002151 O Mango-babyfood 5.000000 1.000 1.000 

95002160 O Mango, dried 5.000000 1.000 1.000 

95002170 O Mango, juice 5.000000 1.000 1.000 

95002171 O Mango, juice-babyfood 5.000000 1.000 1.000 

95002450 O Papaya 5.000000 1.000 1.000 

95002451 O Papaya-babyfood 5.000000 1.000 1.000 

95002460 O Papaya, dried 5.000000 1.800 1.000 

95002470 O Papaya, juice 5.000000 1.500 1.000 

95002520 O Passionfruit 5.000000 1.000 1.000 

95002521 O Passionfruit-babyfood 5.000000 1.000 1.000 

95002530 O Passionfruit, juice 5.000000 1.000 1.000 

95002531 O Passionfruit, juice-babyfood 5.000000 1.000 1.000 

95002630 O Peanut 0.010000 1.000 1.000 

95002640 O Peanut, butter 0.010000 1.890 1.000 

95002650 O Peanut, oil 0.010000 1.000 1.000 

95002790 O Pineapple 20.000000 1.000 1.000 

95002791 O Pineapple-babyfood 20.000000 1.000 1.000 

95002800 O Pineapple, dried 20.000000 5.000 1.000 

95002810 O Pineapple, juice 20.000000 1.700 1.000 

95002811 O Pineapple, juice-babyfood 20.000000 1.700 1.000 

95002890 O Pomegranate 5.000000 1.000 1.000 

95003330 O Sapote, Mamey 5.000000 1.000 1.000 

95003460 O Soursop 20.000000 1.000 1.000 

95003510 O Spanish lime 20.000000 1.000 1.000 

95003580 O Starfruit 5.000000 1.000 1.000 

95003590 O Strawberry 3.000000 1.000 1.000 

95003591 O Strawberry-babyfood 3.000000 1.000 1.000 

95003600 O Strawberry, juice 3.000000 1.000 1.000 

95003601 O Strawberry, juice-babyfood 3.000000 1.000 1.000 

95003610 O Sugar apple 20.000000 1.000 1.000 

95003800 O Tomato, Tree 5.000000 1.000 1.000 

95003980 O Watercress 7.000000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 17 of 25

Attachment 2: DEEM-FCIDTM Acute Exposure and Risk Estimates

U.S. Environmental Protection Agency Ver. 2.02

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

Residue file: 2012_071503a.R98 Adjustment factor #2 used.

Analysis Date: 05-22-2012/15:59:13 Residue file dated: 05-22-2012/15:58:30/8

NOEL (Acute) = 100.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "DPR Work-share Acute/Chronic Dietary with new FY04 Section 3 Tol

erances"

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

Summary calculations (per capita):

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

Females 13-49 yrs:

 0.164096 16.41 609 0.284802 28.48 351 0.610556 61.06 163 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 18 of 25

Attachment 3: DEEM-FCIDTM Chronic Residue File

Filename: C:\Documents and Settings\gkramer\My 

Documents\Gk\##Fludioxonil\2012_071503c_Harm.R98

Chemical: Fludioxonil

RfD(Chronic): .033 mg/kg bw/day NOEL(Chronic): 3.3 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 100 mg/kg bw/day

Date created/last modified: 05-17-2012/13:27:02/8 Program ver. 2.03

Comment: DPR Work-share Acute/Chronic Dietary with new FY04 Section 3 Tolerances

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

01010500 1AB Beet, garden, roots 0.750000 1.000 1.000 

01010501 1AB Beet, garden, roots-babyfood 0.750000 1.000 1.000 

01010520 1A Beet, sugar 0.020000 1.000 1.000 

01010521 1A Beet, sugar-babyfood 0.020000 1.000 1.000 

01010530 1A Beet, sugar, molasses 0.020000 1.000 1.000 

01010531 1A Beet, sugar, molasses-babyfood 0.020000 1.000 1.000 

01010670 1AB Burdock 0.750000 1.000 1.000 

01010780 1AB Carrot 0.750000 1.000 1.000 

01010781 1AB Carrot-babyfood 0.750000 1.000 1.000 

01010790 1AB Carrot, juice 0.750000 1.000 1.000 

01010840 1AB Celeriac 0.750000 1.000 1.000 

01011000 1AB Chicory, roots 0.750000 1.000 1.000 

01011680 1AB Ginseng, dried 4.000000 1.000 1.000 

01011900 1AB Horseradish 0.750000 1.000 1.000 

01012500 1AB Parsley, turnip rooted 0.750000 1.000 1.000 

01012510 1AB Parsnip 0.750000 1.000 1.000 

01012511 1AB Parsnip-babyfood 0.750000 1.000 1.000 

01013140 1AB Radish, roots 0.750000 1.000 1.000 

01013160 1AB Radish, Oriental, roots 0.750000 1.000 1.000 

01013270 1AB Rutabaga 0.750000 1.000 1.000 

01013310 1AB Salsify, roots 0.750000 1.000 1.000 

01013880 1AB Turnip, roots 0.750000 1.000 1.000 

01030150 1CD Arrowroot, flour 6.000000 1.000 1.000 

01030151 1CD Arrowroot, flour-babyfood 6.000000 1.000 1.000 

01030170 1CD Artichoke, Jerusalem 6.000000 1.000 1.000 

01030820 1CD Cassava 6.000000 1.000 1.000 

01030821 1CD Cassava-babyfood 6.000000 1.000 1.000 

01031390 1CD Dasheen, corm 6.000000 1.000 1.000 

01031660 1CD Ginger 6.000000 1.000 1.000 

01031661 1CD Ginger-babyfood 6.000000 1.000 1.000 

01031670 1CD Ginger, dried 6.000000 1.000 1.000 

01032960 1C Potato, chips 1.820000 1.000 1.000 

01032970 1C Potato, dry (granules/ flakes) 1.820000 1.000 1.000 

01032971 1C Potato, dry (granules/ flakes)-b 1.820000 1.000 1.000 

01032980 1C Potato, flour 1.820000 1.000 1.000 

01032981 1C Potato, flour-babyfood 1.820000 1.000 1.000 

01032990 1C Potato, tuber, w/peel 1.820000 1.000 1.000 

01032991 1C Potato, tuber, w/peel-babyfood 1.820000 1.000 1.000 

01033000 1C Potato, tuber, w/o peel 1.820000 1.000 1.000 

01033001 1C Potato, tuber, w/o peel-babyfood 1.820000 1.000 1.000 

01033660 1CD Sweet potato 6.000000 1.000 1.000 

01033661 1CD Sweet potato-babyfood 6.000000 1.000 1.000 

01033710 1CD Tanier, corm 6.000000 1.000 1.000 

01033870 1CD Turmeric 6.000000 1.000 1.000 

01034060 1CD Yam, true 8.000000 1.000 1.000 

01034070 1CD Yam bean 6.000000 1.000 1.000 

02000510 2 Beet, garden, tops 30.000000 1.000 1.000 

02001010 2 Chicory, tops 30.000000 1.000 1.000 

02001400 2 Dasheen, leaves 30.000000 1.000 1.000 

02003150 2 Radish, tops 30.000000 1.000 1.000 

02003170 2 Radish, Oriental, tops 30.000000 1.000 1.000 

02003320 2 Salsify, tops 30.000000 1.000 1.000 

03001640 3 Garlic 0.500000 1.000 1.000 

03001650 3 Garlic, dried 0.500000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 19 of 25

03001651 3 Garlic, dried-babyfood 0.500000 1.000 1.000 

03001980 3 Leek 7.000000 1.000 1.000 

03002370 3 Onion, dry bulb 0.500000 1.000 1.000 

03002371 3 Onion, dry bulb-babyfood 0.500000 1.000 1.000 

03002380 3 Onion, dry bulb, dried 0.500000 9.000 1.000 

03002381 3 Onion, dry bulb, dried-babyfood 0.500000 9.000 1.000 

03002390 3 Onion, green 7.000000 1.000 1.000 

03003380 3 Shallot 0.500000 1.000 1.000 

04010050 4A Amaranth, leafy 30.000000 1.000 1.000 

04010180 4A Arugula 30.000000 1.000 1.000 

04011040 4A Chrysanthemum, garland 30.000000 1.000 1.000 

04011330 4A Cress, garden 30.000000 1.000 1.000 

04011340 4A Cress, upland 30.000000 1.000 1.000 

04011380 4A Dandelion, leaves 30.000000 1.000 1.000 

04011500 4A Endive 30.000000 1.000 1.000 

04012040 4A Lettuce, head 2.090000 1.000 1.000 AR hea

 Full comment: AR head lettuce (w/ wrapper leaves)

04012050 4A Lettuce, leaf 10.770000 1.000 1.000 AR lea

 Full comment: AR leaf lettuce

04012480 4A Parsley, leaves 1.230000 1.000 1.000 AR; pa

 Full comment: AR; parsely field trials

04013130 4A Radicchio 30.000000 1.000 1.000 

04013550 4A Spinach 7.100000 1.000 1.000 

04013551 4A Spinach-babyfood 7.100000 1.000 1.000 

04020760 4B Cardoon 15.000000 1.000 1.000 

04020850 4B Celery 4.900000 1.000 1.000 

04020851 4B Celery-babyfood 4.900000 1.000 1.000 

04020860 4B Celery, juice 4.900000 1.000 1.000 

04020870 4B Celtuce 15.000000 1.000 1.000 

04021520 4B Fennel, Florence 15.000000 1.000 1.000 

04023220 4B Rhubarb 15.000000 1.000 1.000 

04023670 4B Swiss chard 15.000000 1.000 1.000 

05010610 5A Broccoli 0.130000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05010611 5A Broccoli-babyfood 0.130000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05010620 5A Broccoli, Chinese 0.130000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05010640 5A Brussels sprouts 0.340000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05010690 5A Cabbage 0.340000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05010710 5A Cabbage, Chinese, napa 0.340000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05010720 5A Cabbage, Chinese, mustard 0.130000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05010830 5A Cauliflower 0.130000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05011960 5A Kohlrabi 0.340000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05020630 5B Broccoli raab 1.030000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05020700 5B Cabbage, Chinese, bok choy 1.030000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05021170 5B Collards 1.030000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05021940 5B Kale 1.030000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05022290 5B Mustard greens 1.030000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05023180 5B Rape greens 1.030000 1.000 1.000 AR; DP

 Full comment: AR; DP#345970

05023890 5B Turnip, greens 10.000000 1.000 1.000 

06003470 6 Soybean, seed 0.010000 1.000 1.000 

06003480 6 Soybean, flour 0.010000 1.000 1.000 

06003481 6 Soybean, flour-babyfood 0.010000 1.000 1.000 

06003490 6 Soybean, soy milk 0.010000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 20 of 25

06003491 6 Soybean, soy milk-babyfood or in 0.010000 1.000 1.000 

06003500 6 Soybean, oil 0.010000 1.000 1.000 

06003501 6 Soybean, oil-babyfood 0.010000 1.000 1.000 

06010430 6A Bean, snap, succulent 0.400000 1.000 1.000 

06010431 6A Bean, snap, succulent-babyfood 0.400000 1.000 1.000 

06012570 6A Pea, edible podded, succulent 0.010000 1.000 1.000 

06020310 6B Bean, broad, succulent 0.400000 1.000 1.000 

06020330 6B Bean, cowpea, succulent 0.400000 1.000 1.000 

06020370 6B Bean, lima, succulent 0.400000 1.000 1.000 

06022550 6B Pea, succulent 0.010000 1.000 1.000 

06022551 6B Pea, succulent-babyfood 0.010000 1.000 1.000 

06022590 6B Pea, pigeon, succulent 0.010000 1.000 1.000 

06030300 6C Bean, black, seed 0.400000 1.000 1.000 

06030320 6C Bean, broad, seed 0.400000 1.000 1.000 

06030340 6C Bean, cowpea, seed 0.400000 1.000 1.000 

06030350 6C Bean, great northern, seed 0.400000 1.000 1.000 

06030360 6C Bean, kidney, seed 0.400000 1.000 1.000 

06030380 6C Bean, lima, seed 0.400000 1.000 1.000 

06030390 6C Bean, mung, seed 0.400000 1.000 1.000 

06030400 6C Bean, navy, seed 0.400000 1.000 1.000 

06030410 6C Bean, pink, seed 0.400000 1.000 1.000 

06030420 6C Bean, pinto, seed 0.400000 1.000 1.000 

06030980 6C Chickpea, seed 0.400000 1.000 1.000 

06030981 6C Chickpea, seed-babyfood 0.400000 1.000 1.000 

06030990 6C Chickpea, flour 0.400000 1.000 1.000 

06031820 6C Guar, seed 0.400000 1.000 1.000 

06031821 6C Guar, seed-babyfood 0.400000 1.000 1.000 

06032030 6C Lentil, seed 0.400000 1.000 1.000 

06032560 6C Pea, dry 0.010000 1.000 1.000 

06032561 6C Pea, dry-babyfood 0.010000 1.000 1.000 

06032580 6C Pea, pigeon, seed 0.010000 1.000 1.000 

08001480 8 Eggplant 0.500000 1.000 1.000 

08002340 8 Okra 0.500000 1.000 1.000 

08002700 8 Pepper, bell 0.500000 1.000 1.000 

08002701 8 Pepper, bell-babyfood 0.500000 1.000 1.000 

08002710 8 Pepper, bell, dried 0.500000 1.000 1.000 

08002711 8 Pepper, bell, dried-babyfood 0.500000 1.000 1.000 

08002720 8 Pepper, nonbell 0.500000 1.000 1.000 

08002721 8 Pepper, nonbell-babyfood 0.500000 1.000 1.000 

08002730 8 Pepper, nonbell, dried 0.500000 1.000 1.000 

08003740 8 Tomatillo 0.500000 1.000 1.000 AR

08003750 8 Tomato 0.890000 1.000 1.000 AR

08003751 8 Tomato-babyfood 0.890000 1.000 1.000 AR

08003760 8 Tomato, paste 0.890000 1.000 1.000 AR; pr

 Full comment: AR; processing study

08003761 8 Tomato, paste-babyfood 0.890000 1.000 1.000 AR; pr

 Full comment: AR; processing study

08003770 8 Tomato, puree 0.890000 1.000 1.000 AR; pr

 Full comment: AR; processing study

08003771 8 Tomato, puree-babyfood 0.890000 1.000 1.000 AR; pr

 Full comment: AR; processing study

08003780 8 Tomato, dried 0.890000 14.300 1.000 AR

08003781 8 Tomato, dried-babyfood 0.890000 14.300 1.000 AR

08003790 8 Tomato, juice 0.890000 1.000 1.000 AR; pr

 Full comment: AR; processing study

09010750 9A Cantaloupe 0.450000 1.000 1.000 

09010800 9A Casaba 0.450000 1.000 1.000 

09011870 9A Honeydew melon 0.450000 1.000 1.000 

09013990 9A Watermelon 0.450000 1.000 1.000 

09014000 9A Watermelon, juice 0.450000 1.000 1.000 

09020210 9B Balsam pear 0.450000 1.000 1.000 

09020880 9B Chayote, fruit 0.450000 1.000 1.000 

09021020 9B Chinese waxgourd 0.450000 1.000 1.000 

09021350 9B Cucumber 0.450000 1.000 1.000 

09023080 9B Pumpkin 0.450000 1.000 1.000 

09023090 9B Pumpkin, seed 0.450000 1.000 1.000 

09023560 9B Squash, summer 0.450000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 21 of 25

09023561 9B Squash, summer-babyfood 0.450000 1.000 1.000 

09023570 9B Squash, winter 0.450000 1.000 1.000 

09023571 9B Squash, winter-babyfood 0.450000 1.000 1.000 

10001060 10 Citrus citron 10.000000 1.000 1.000 

10001070 10 Citrus hybrids 10.000000 1.000 1.000 

10001080 10 Citrus, oil 500.000000 1.000 1.000 

10001800 10 Grapefruit 2.600000 1.000 1.000 AR

10001810 10 Grapefruit, juice 0.740000 1.000 1.000 AR

10001970 10 Kumquat 10.000000 1.000 1.000 

10001990 10 Lemon 1.700000 1.000 1.000 AR

10002000 10 Lemon, juice 0.020000 1.000 1.000 AR

10002001 10 Lemon, juice-babyfood 0.020000 1.000 1.000 AR

10002010 10 Lemon, peel 1.700000 1.000 1.000 AR

10002060 10 Lime 1.700000 1.000 1.000 AR

10002070 10 Lime, juice 0.020000 1.000 1.000 AR

10002071 10 Lime, juice-babyfood 0.020000 1.000 1.000 AR

10002400 10 Orange 1.500000 1.000 1.000 AR

10002420 10 Orange, peel 1.500000 1.000 1.000 AR

10003070 10 Pummelo 10.000000 1.000 1.000 

10003690 10 Tangerine 1.500000 1.000 1.000 AR

10003700 10 Tangerine, juice 0.740000 1.000 1.000 AR

11000070 11 Apple, fruit with peel 1.100000 1.000 1.000 AR

11000080 11 Apple, peeled fruit 1.100000 1.000 1.000 AR

11000081 11 Apple, peeled fruit-babyfood 1.100000 1.000 1.000 AR

11000090 11 Apple, dried 1.100000 8.000 1.000 AR

11000091 11 Apple, dried-babyfood 1.100000 8.000 1.000 AR

11000100 11 Apple, juice 0.100000 1.000 1.000 AR

11000101 11 Apple, juice-babyfood 0.100000 1.000 1.000 AR

11000110 11 Apple, sauce 1.100000 1.000 1.000 AR

11000111 11 Apple, sauce-babyfood 1.100000 1.000 1.000 AR

11001290 11 Crabapple 5.000000 1.000 1.000 

11002100 11 Loquat 5.000000 1.000 1.000 

11002660 11 Pear 1.600000 1.000 1.000 AR

11002661 11 Pear-babyfood 1.600000 1.000 1.000 AR

11002670 11 Pear, dried 1.600000 6.250 1.000 AR

11002680 11 Pear, juice 1.600000 1.000 1.000 AR

11002681 11 Pear, juice-babyfood 1.600000 1.000 1.000 AR

11003100 11 Quince 5.000000 1.000 1.000 

12000120 12 Apricot 5.000000 1.000 1.000 

12000121 12 Apricot-babyfood 5.000000 1.000 1.000 

12000130 12 Apricot, dried 5.000000 6.000 1.000 

12000140 12 Apricot, juice 5.000000 1.000 1.000 

12000141 12 Apricot, juice-babyfood 5.000000 1.000 1.000 

12000900 12 Cherry 0.820000 1.000 1.000 AR

12000901 12 Cherry-babyfood 0.820000 1.000 1.000 AR

12000910 12 Cherry, juice 0.820000 1.500 1.000 AR

12000911 12 Cherry, juice-babyfood 0.820000 1.500 1.000 AR

12002300 12 Nectarine 5.000000 1.000 1.000 

12002600 12 Peach 0.400000 1.000 1.000 AR

12002601 12 Peach-babyfood 0.400000 1.000 1.000 AR

12002610 12 Peach, dried 0.400000 7.000 1.000 AR

12002611 12 Peach, dried-babyfood 0.400000 7.000 1.000 AR

12002620 12 Peach, juice 0.400000 1.000 1.000 AR

12002621 12 Peach, juice-babyfood 0.400000 1.000 1.000 AR

12002850 12 Plum 0.510000 1.000 1.000 AR

12002851 12 Plum-babyfood 0.510000 1.000 1.000 AR

12002860 12 Plum, prune, fresh 0.510000 1.000 1.000 AR

12002861 12 Plum, prune, fresh-babyfood 0.510000 1.000 1.000 AR

12002870 12 Plum, prune, dried 0.510000 5.000 1.000 AR

12002871 12 Plum, prune, dried-babyfood 0.510000 5.000 1.000 AR

12002880 12 Plum, prune, juice 0.510000 1.400 1.000 AR

12002881 12 Plum, prune, juice-babyfood 0.510000 1.400 1.000 AR

13010550 13A Blackberry 5.000000 1.000 1.000 

13010560 13A Blackberry, juice 5.000000 1.000 1.000 

13010561 13A Blackberry, juice-babyfood 5.000000 1.000 1.000 

13010580 13A Boysenberry 5.000000 1.000 1.000 

13011420 13A Dewberry 5.000000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

_____________________________________________________________________________________________

Page 22 of 25

13012080 13A Loganberry 5.000000 1.000 1.000 

13013200 13A Raspberry 5.000000 1.000 1.000 

13013201 13A Raspberry-babyfood 5.000000 1.000 1.000 

13013210 13A Raspberry, juice 5.000000 1.000 1.000 

13013211 13A Raspberry, juice-babyfood 5.000000 1.000 1.000 

13020570 13B Blueberry 3.000000 1.000 1.000 

13020571 13B Blueberry-babyfood 3.000000 1.000 1.000 

13021360 13B Currant 2.000000 1.000 1.000 

13021370 13B Currant, dried 2.000000 1.000 1.000 

13021490 13B Elderberry 2.000000 1.000 1.000 

13021740 13B Gooseberry 2.000000 1.000 1.000 

13021910 13B Huckleberry 2.000000 1.000 1.000 

14002820 14 Pistachio 0.100000 1.000 1.000 

15000250 15 Barley, pearled barley 0.020000 1.000 1.000 

15000251 15 Barley, pearled barley-babyfood 0.020000 1.000 1.000 

15000260 15 Barley, flour 0.020000 1.000 1.000 

15000261 15 Barley, flour-babyfood 0.020000 1.000 1.000 

15000270 15 Barley, bran 0.020000 1.000 1.000 

15000650 15 Buckwheat 0.020000 1.000 1.000 

15000660 15 Buckwheat, flour 0.020000 1.000 1.000 

15001200 15 Corn, field, flour 0.020000 1.000 1.000 

15001201 15 Corn, field, flour-babyfood 0.020000 1.000 1.000 

15001210 15 Corn, field, meal 0.020000 1.000 1.000 

15001211 15 Corn, field, meal-babyfood 0.020000 1.000 1.000 

15001220 15 Corn, field, bran 0.020000 1.000 1.000 

15001230 15 Corn, field, starch 0.020000 1.000 1.000 

15001231 15 Corn, field, starch-babyfood 0.020000 1.000 1.000 

15001240 15 Corn, field, syrup 0.020000 1.500 1.000 

15001241 15 Corn, field, syrup-babyfood 0.020000 1.500 1.000 

15001250 15 Corn, field, oil 0.020000 1.000 1.000 

15001251 15 Corn, field, oil-babyfood 0.020000 1.000 1.000 

15001260 15 Corn, pop 0.020000 1.000 1.000 

15001270 15 Corn, sweet 0.020000 1.000 1.000 

15001271 15 Corn, sweet-babyfood 0.020000 1.000 1.000 

15002260 15 Millet, grain 0.020000 1.000 1.000 

15002310 15 Oat, bran 0.020000 1.000 1.000 

15002320 15 Oat, flour 0.020000 1.000 1.000 

15002321 15 Oat, flour-babyfood 0.020000 1.000 1.000 

15002330 15 Oat, groats/rolled oats 0.020000 1.000 1.000 

15002331 15 Oat, groats/rolled oats-babyfood 0.020000 1.000 1.000 

15003230 15 Rice, white 0.020000 1.000 1.000 

15003231 15 Rice, white-babyfood 0.020000 1.000 1.000 

15003240 15 Rice, brown 0.020000 1.000 1.000 

15003241 15 Rice, brown-babyfood 0.020000 1.000 1.000 

15003250 15 Rice, flour 0.020000 1.000 1.000 

15003251 15 Rice, flour-babyfood 0.020000 1.000 1.000 

15003260 15 Rice, bran 0.020000 1.000 1.000 

15003261 15 Rice, bran-babyfood 0.020000 1.000 1.000 

15003280 15 Rye, grain 0.020000 1.000 1.000 

15003290 15 Rye, flour 0.020000 1.000 1.000 

15003440 15 Sorghum, grain 0.020000 1.000 1.000 

15003450 15 Sorghum, syrup 0.020000 1.000 1.000 

15003810 15 Triticale, flour 0.020000 1.000 1.000 

15003811 15 Triticale, flour-babyfood 0.020000 1.000 1.000 

15004010 15 Wheat, grain 0.020000 1.000 1.000 

15004011 15 Wheat, grain-babyfood 0.020000 1.000 1.000 

15004020 15 Wheat, flour 0.020000 1.000 1.000 

15004021 15 Wheat, flour-babyfood 0.020000 1.000 1.000 

15004030 15 Wheat, germ 0.020000 1.000 1.000 

15004040 15 Wheat, bran 0.020000 1.000 1.000 

15004050 15 Wild rice 0.020000 1.000 1.000 

19010280 19A Basil, fresh leaves 10.000000 1.000 1.000 

19010281 19A Basil, fresh leaves-babyfood 10.000000 1.000 1.000 

19010290 19A Basil, dried leaves 65.000000 1.000 1.000 

19010291 19A Basil, dried leaves-babyfood 65.000000 1.000 1.000 

19011030 19A Chive 10.000000 1.000 1.000 

19011180 19A Coriander, leaves 10.000000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Page 23 of 25

19011181 19A Coriander, leaves-babyfood 10.000000 1.000 1.000 

19011440 19A Dillweed 10.000000 1.000 1.000 

19011840 19A Herbs, other 65.000000 1.000 1.000 

19011841 19A Herbs, other-babyfood 65.000000 1.000 1.000 

19012020 19A Lemongrass 10.000000 1.000 1.000 

19012200 19A Marjoram 10.000000 1.000 1.000 

19012201 19A Marjoram-babyfood 10.000000 1.000 1.000 

19012490 19A Parsley, dried leaves 65.000000 1.000 1.000 

19012491 19A Parsley, dried leaves-babyfood 65.000000 1.000 1.000 

19013340 19A Savory 10.000000 1.000 1.000 

19021050 19B Cinnamon 0.020000 1.000 1.000 

19021051 19B Cinnamon-babyfood 0.020000 1.000 1.000 

19021190 19B Coriander, seed 0.020000 1.000 1.000 

19021191 19B Coriander, seed-babyfood 0.020000 1.000 1.000 

19021430 19B Dill, seed 0.020000 1.000 1.000 

19022740 19B Pepper, black and white 0.020000 1.000 1.000 

19022741 19B Pepper, black and white-babyfood 0.020000 1.000 1.000 

19023540 19B Spices, other 0.020000 1.000 1.000 

19023541 19B Spices, other-babyfood 0.020000 1.000 1.000 

20001630 20 Flaxseed, oil 0.050000 1.000 1.000 

20003190 20 Rapeseed, oil 0.010000 1.000 1.000 

20003191 20 Rapeseed, oil-babyfood 0.010000 1.000 1.000 

20003300 20 Safflower, oil 0.010000 1.000 1.000 

20003301 20 Safflower, oil-babyfood 0.010000 1.000 1.000 

20003640 20 Sunflower, seed 0.010000 1.000 1.000 

20003650 20 Sunflower, oil 0.010000 1.000 1.000 

20003651 20 Sunflower, oil-babyfood 0.010000 1.000 1.000 

21000440 M Beef, meat 0.010000 1.000 1.000 

21000441 M Beef, meat-babyfood 0.010000 1.000 1.000 

21000450 M Beef, meat, dried 0.010000 1.920 1.000 

21000460 M Beef, meat byproducts 0.050000 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.050000 1.000 1.000 

21000470 M Beef, fat 0.050000 1.000 1.000 

21000471 M Beef,fat-babyfood 0.050000 1.000 1.000 

21000480 M Beef, kidney 0.050000 1.000 1.000 

21000490 M Beef, liver 0.050000 1.000 1.000 

21000491 M Beef, liver-babyfood 0.050000 1.000 1.000 

23001690 M Goat, meat 0.010000 1.000 1.000 

23001700 M Goat, meat byproducts 0.050000 1.000 1.000 

23001710 M Goat, fat 0.050000 1.000 1.000 

23001720 M Goat, kidney 0.050000 1.000 1.000 

23001730 M Goat, liver 0.050000 1.000 1.000 

24001890 M Horse, meat 0.010000 1.000 1.000 

26003390 M Sheep, meat 0.010000 1.000 1.000 

26003391 M Sheep, meat-babyfood 0.010000 1.000 1.000 

26003400 M Sheep, meat byproducts 0.050000 1.000 1.000 

26003410 M Sheep, fat 0.050000 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.050000 1.000 1.000 

26003420 M Sheep, kidney 0.050000 1.000 1.000 

26003430 M Sheep, liver 0.050000 1.000 1.000 

27002220 D Milk, fat 0.010000 1.000 1.000 

27002221 D Milk, fat - baby food/infant for 0.010000 1.000 1.000 

27012230 D Milk, nonfat solids 0.010000 1.000 1.000 

27012231 D Milk, nonfat solids-baby food/in 0.010000 1.000 1.000 

27022240 D Milk, water 0.010000 1.000 1.000 

27022241 D Milk, water-babyfood/infant form 0.010000 1.000 1.000 

27032251 D Milk, sugar (lactose)-baby food/ 0.010000 1.000 1.000 

86010000 O Water, direct, all sources 0.038500 1.000 1.000 

86020000 O Water, indirect, all sources 0.038500 1.000 1.000 

95000010 O Acerola 5.000000 1.000 1.000 

95000200 O Avocado 5.000000 1.000 1.000 

95000740 O Canistel 5.000000 1.000 1.000 

95000890 O Cherimoya 20.000000 1.000 1.000 

95001280 O Cottonseed, oil 0.050000 1.000 1.000 

95001281 O Cottonseed, oil-babyfood 0.050000 1.000 1.000 

95001510 O Feijoa 5.000000 1.000 1.000 

95001750 O Grape 0.330000 1.000 1.000 AR; DP
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Page 24 of 25

 Full comment: AR; DP#348539

95001760 O Grape, juice 0.330000 0.420 1.000 AR; DP

 Full comment: AR; DP#348539

95001761 O Grape, juice-babyfood 0.330000 0.420 1.000 AR; DP

 Full comment: AR; DP#348539

95001770 O Grape, leaves 0.330000 1.000 1.000 AR; DP

 Full comment: AR; DP#348539

95001780 O Grape, raisin 0.330000 1.650 1.000 AR; DP

 Full comment: AR; DP#348539

95001790 O Grape, wine and sherry 0.330000 1.000 1.000 AR; DP

 Full comment: AR; DP#348539

95001830 O Guava 5.000000 1.000 1.000 

95001831 O Guava-babyfood 5.000000 1.000 1.000 

95001920 O Jaboticaba 5.000000 1.000 1.000 

95001950 O Kiwifruit 20.000000 1.000 1.000 

95002090 O Longan 20.000000 1.000 1.000 

95002110 O Lychee 20.000000 1.000 1.000 

95002120 O Lychee, dried 20.000000 1.850 1.000 

95002150 O Mango 5.000000 1.000 1.000 

95002151 O Mango-babyfood 5.000000 1.000 1.000 

95002160 O Mango, dried 5.000000 1.000 1.000 

95002170 O Mango, juice 5.000000 1.000 1.000 

95002171 O Mango, juice-babyfood 5.000000 1.000 1.000 

95002450 O Papaya 5.000000 1.000 1.000 

95002451 O Papaya-babyfood 5.000000 1.000 1.000 

95002460 O Papaya, dried 5.000000 1.800 1.000 

95002470 O Papaya, juice 5.000000 1.500 1.000 

95002520 O Passionfruit 5.000000 1.000 1.000 

95002521 O Passionfruit-babyfood 5.000000 1.000 1.000 

95002530 O Passionfruit, juice 5.000000 1.000 1.000 

95002531 O Passionfruit, juice-babyfood 5.000000 1.000 1.000 

95002630 O Peanut 0.010000 1.000 1.000 

95002640 O Peanut, butter 0.010000 1.890 1.000 

95002650 O Peanut, oil 0.010000 1.000 1.000 

95002790 O Pineapple 5.640000 1.000 1.000 

95002791 O Pineapple-babyfood 5.640000 1.000 1.000 

95002800 O Pineapple, dried 5.640000 5.000 1.000 

95002810 O Pineapple, juice 5.640000 1.000 1.000 

95002811 O Pineapple, juice-babyfood 5.640000 1.000 1.000 

95002890 O Pomegranate 5.000000 1.000 1.000 

95003330 O Sapote, Mamey 5.000000 1.000 1.000 

95003460 O Soursop 20.000000 1.000 1.000 

95003510 O Spanish lime 20.000000 1.000 1.000 

95003580 O Starfruit 5.000000 1.000 1.000 

95003590 O Strawberry 3.000000 1.000 1.000 

95003591 O Strawberry-babyfood 3.000000 1.000 1.000 

95003600 O Strawberry, juice 3.000000 1.000 1.000 

95003601 O Strawberry, juice-babyfood 3.000000 1.000 1.000 

95003610 O Sugar apple 20.000000 1.000 1.000 

95003800 O Tomato, Tree 5.000000 1.000 1.000 

95003980 O Watercress 7.000000 1.000 1.000 
Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Page 25 of 25

Attachment 4: DEEM-FCIDTM Chronic Exposure and Risk Estimates

U.S. Environmental Protection Agency Ver. 2.00

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

Residue file name: C:\Documents and Settings\gkramer\My 

Documents\Gk\##Fludioxonil\2012_071503c_Harm.R98

 Adjustment factor #2 used.

Analysis Date 05-17-2012/13:29:15 Residue file dated: 05-17-2012/13:27:02/8

Reference dose (RfD, Chronic) = .033 mg/kg bw/day

COMMENT 1: DPR Work-share Acute/Chronic Dietary with new FY04 Section 3 Tolerances

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

U.S. Population (total) 0.008711 26.4%

U.S. Population (spring season) 0.008905 27.0%

U.S. Population (summer season) 0.008622 26.1%

U.S. Population (autumn season) 0.008578 26.0%

U.S. Population (winter season) 0.008755 26.5%

Northeast region 0.008693 26.3%

Midwest region 0.008731 26.5%

Southern region 0.007925 24.0%

Western region 0.009952 30.2%

Hispanics 0.009658 29.3%

Non-hispanic whites 0.008593 26.0%

Non-hispanic blacks 0.007937 24.1%

Non-hisp/non-white/non-black 0.010602 32.1%

All infants (< 1 year) 0.018891 57.2%

Nursing infants 0.010595 32.1%

Non-nursing infants 0.022040 66.8%

Children 1-6 yrs 0.018682 56.6%

Children 7-12 yrs 0.010537 31.9%

Females 13-19 (not preg or nursing) 0.006151 18.6%

Females 20+ (not preg or nursing) 0.007503 22.7%

Females 13-50 yrs 0.007562 22.9%

Females 13+ (preg/not nursing) 0.009275 28.1%

Females 13+ (nursing) 0.009753 29.6%

Males 13-19 yrs 0.006920 21.0%

Males 20+ yrs 0.006899 20.9%

Seniors 55+ 0.007875 23.9%

Children 1-2 yrs 0.022497 68.2%

Children 3-5 yrs 0.017817 54.0%

Children 6-12 yrs 0.011011 33.4%

Youth 13-19 yrs 0.006547 19.8%

Adults 20-49 yrs 0.006943 21.0%

Adults 50+ yrs 0.007778 23.6%

Females 13-49 yrs 0.007073 21.4%

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