Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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### UNITED STA**TES ENVIRONMENTA L PROTECTION A**  **GENCY**

**WA SHINGTON, 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 Use s on Ginseng, Leaf y Petioles Crop Subgroup 4B, Pineapple (post - harvest treatment), Tuberous and Corm Vegetable Subgroup 1C , Tropical Fruit (post - harvest treatment), Bulb Onion Subgroup 3 - 07A, Gr een 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:** D38998 1 **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 **T XR 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/L isa 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 - FCID TM 

### , Version 2.03) which uses food consumption data from the U.S. Department of Agriculture’s (USDA’s) Continuing Survey s of Food Intakes byFludioxonil Dietary Exposure and Risk Assessment DP# 389981

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### Individuals (CSFII) from 1994 - 1996 and 1998. These anal ys es were performed to support the proposed Section 3 use s 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, an d tomato (post - harvest treatment) . Acute Dietary

(Food and Drinking Water) Exposure Results and Characterization An unrefined acute dietary exposure and risk anal ys i s was performed assuming tolerance - level residues, 100% crop - treated (CT), and DEEM TM 

### (ver. 7.81 ) default processing factors. T he 1 - in 10 - ye ar acute drinking water estimate (i.e., relevant to acute exposure) of 0.0 8 38 pp m , previously provided by Environmental Fate and Effects Division ( EFED ) , was directl y incorporated into the acute asses sment. This analy sis was performed for the population subgroup females 13 to 49 ye ars old ; the only subgroup of interest for acute exposure. The acute dietary (food plus water) risk utilizes 1 6 % 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 parsl e y , Brassica leafy

vegetables (crop group 5), grape, cherry , peach and plum ] , 100% CT estimates, and DEEM TM 

### (ver. 7.81 ) default processing factors [ with the exception of citrus fruit juice s (1 X ), apple juice (1 X ), grape juice (0.42X), raisin (1.65X) , potato commodities (1X), and tomato commodities (1 X ) , 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

v egetables (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 inc orporated 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 ye ars 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 dos e. 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 b y the required uncertainty or safet y factors. Dietary risk is expressed as a percentage of the PAD.Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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 ( 0 8/20/1999). The most re cent dietary

risk assessment for fludioxonil was conducted by D. Rate ( D P# 379936 , 07 / 1 4/20 1 0 ). **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 ) - 1 H

– py rrole - 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 (D P# 262022, W. Donovan et al ., 01/18/2000). As part of a previous tolerance p etition memo, an additional reviewed plant metabolism study reconfirmed fludioxonil as the only

residue of concern (D P# 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 b y 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 ppmFludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Page 4 of 25 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 Lo w 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 - py rrole - 3 - carbonitrile), and its metabolites converted to 2,2 - difluoro - l,3 - benzodioxole - 4 - carbox yl ic 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 by

products 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 to lerances be expanded to their respective crop groups or crop subgroups.Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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### Residue Data Used for Acute and Chronic Assessments : Established and recommended t olerance - level residues , 100% CT, and DEEM TM 

### (ver. 7.81) default processing factors were utilized f or 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 previousl y generated from field trial data ( D. Rate, DP# 379936 , 07/14/2010 ) . ARs for tomato , celery , pineapple, potato, and spinach were also generated from fi el d trial data for this assessment , see Table 1, below. For Brassica leafy vegetables (crop group 5), the f ield trial data were translated from the representative commodities in the crop groups to the non - representative commodities according to HED SOP 2000.1: “Guidan ce 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, 0 2/27/2004) 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 appreciabl y 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 1 X for these processed commodities (pineapple juice ; tomato paste, juice, and puree ; and potato chips, flakes, and flour) . DEEM TM 

### (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.** 

**Comm odity**  **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 Orange 1 , whole juice 1.5 0. 0 Pear, whole 1.6 Tomato 0.89 Lettuce, head (w ith w

rapper 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 0.13Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Page 6 of 25 **Table 1. AR**  **Values Used for the Chronic Assessment.**  **Comm odity**  **AR (ppm)**  **2** Grape 0.33 Cherry 0.82 Peach 0.40 Plum 0.51 C elery 4.9 P ineapple 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 Analy sis Modeling Sy stem (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. Percent cropped areas (PCA) that account for the maximum area within a watershed that may be planted with the modeled crop are applied to concentrations pre dicted b y 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 ye ar 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 previousl y assessed by EFED for ornamentals, the EDWC s based on use on ornamentals are recommended for use in the human - health dietary assessment . However, based on information provided in Sy ngenta’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 o f 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 as sessment. 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/y r.Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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### The resulting acute and chronic EDWCs in surface water were 83.8 pp b (1 - in - 10 - year acute estimate) and 38.5 ppb (1 - i n - 10 - year chronic estimate), respectivel y. The EDWC for groundwater (for both acute and chronic anal ys is ) 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. 0 8 38 ppm and 0.0 38 5 ppm, respectivel y, 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 (m**  **odel) 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 

### I **V .**  **DEEM -**  **FCIDTM Program and Consumption Information** Fludioxonil a cute and chronic dietary exposure assessments were conducted using the DEEM FCID TM 

### 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 mo re than 20,000 individuals over two non - consecutive survey day s. Foods “as consumed” (e.g., apple pie) are linked to EPA - defined food commodities (e.g. , apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicl y available recipe translation files developed jointly

by USDA/ARS and EPA. For chronic exposure 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 anal ys is of the 1994 - 96, 98 CSFII consumption data, which took into account dietary patterns and survey r espondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and ad ults 50+ 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 dail y 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 pes ticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., onl y those who reported eating relevant commodities/food forms) and a per - capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capitaFludioxonil Dietary Exposure and Risk Assessment DP# 389981

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### exposure and risk are reported for all tiers of anal ysis. However, for Tiers 1 and 2, an y 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. Dy kstra, 10/13/1999; TXR No. 0050427, W. Dy

kstra, 01/29/2002) and concluded that the 10X safety factor should be reduced to 1X . The mo st recent review of the toxicology database ( DP#3 89613 , G . Kramer et al. , 0 5 /2 1 /20 1 2 ) 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 f

ulfilled 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 expo sure 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** Ac ute 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. Ac ute Dietary (Females 13 - 49 years of age) NOAEL =

100 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X Ac ute RfD = 1.0

mg/kg/day aPAD = 1.0 mg/kg/day **Rat developm ental 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 UF A = 10X

UF H = 10X FQPA SF = 1X Chronic RfD = 0.03 3

mg/kg/day cPAD = 0.03 3 mg/kg/day **One -**  **year dog feeding study .** 

LOAEL = 35.5 mg/kg/day based on based on d ecreased 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 d eparture (POD) = A data point or an estimated point that is derived from observed dose - response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no - observed adverse - effect level. LOAEL = lowest - observed adverse - effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (intraspecies). UF H = potential variation in sensitivity among members of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = population - adjuste d dose (a = acute, c = chronic). RfD = reference dose. N/A = not applicable.Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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### V **I . Results/Discussion**  For acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCID TM 

### analy ses 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 ye ar 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 Analy ses The acute dietary risk for fludioxonil at the 95 th 

### percentile of exposure (food plus water) utilizes 1 6 % 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 an y other population subgroups; therefore, these population subgroups were not included in this assessment. The chroni c 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 ye ars old, is 68 % of the cPAD. The results of the acute and chronic diet ary exposure and risk anal ys es 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 (m**  **g/kg/day) % aPAD** * **Dietary Exposure**  **(m g/kg/day)**  **% cPAD*** General U.S. Population N/A 0.008711 2 6 All Infants (<1 year old) 0.018891 5 7 **Children 1 -**  **2 years old 0.022497**  **68** Children 3 - 5 years old 0.017817 5 4 Children 6 - 12 years old 0.011011 3 3 Youth 13 - 19 years old 0.006547 20 Adults 20 - 49 years old 0.006943 2 1 Adults 50+ years old 0.007778 2 4 **Fem ales 13**  **- 49 years old**  **0.164096 1**  **6** 0.007073 2 1 * % PADs are reported to 2 significant figures. The values for the highest exposed population for each type of risk assessment are bolded. 

### VI **I .**  **Characterization of Inputs/Outputs** These analy ses are conservative dietary exposure assessments. Further refi nement to the anal ys es 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 DEEM TM 

### (ver. 7.81 ) default processing factors. The 1 - in - 10 - ye ar acute drinking water estimate (i.e., relevant to acute exposure) of 0.0838 ppm was directl y incorporated into the acute assessment.Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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 DEEM TM 

### (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 anal ys is. 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 do cument are unlikely to underestimate actual exposure for the following reasons: (1) the analy sis incorporated tolerance level 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. **VII I.**  **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 - harv est 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 to mato (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 onl y subgroup of interest). The acute dietary risk utilizes 16 % of the aPAD at the 95 th 

### percentile 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 cP AD for the general U.S. population ; and , for the most highl y exposed population subgroup ( children 1 - 2 years old) 68 % of the cPAD. **IX. List of Attachments**  Attachment 1: DEEM - FCID TM 

### Acute Residue File Attachment 2: DEEM - FCID TM 

### Acute Exposure and Risk Estimates Attachment 3: DEEM - FCID TM 

### Chronic Residue File Attachment 4: DEEM - FCID TM 

### Chronic Exposure and Risk Estimates

cc: G. Kramer G.F. Kramer:S10957:PY - S:(703)305 - 5079:7509P:RAB1Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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### Attachment 1: DEEM - FCID TM 

### 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 0101050 1 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 Chico ry, 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 0 1013880 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, Jerusa lem 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 Pota to, 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 01033 000 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 - b abyfood 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 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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 Sh allot 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 1.000 040 11500 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 Rhub arb 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 05010 710 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, g reens 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 06030 350 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, see d 0.400000 1.000 1.000 06031821 6C Guar, seed - babyfood 0.400000 1.000 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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 Pepp er, 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 0.4500 00 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 0.45000 0 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 10.00000 0 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 Loqu at 5.000000 1.000 1.000 11002660 11 Pear 5.000000 1.000 1.000 11002661 11 Pear - babyfood 5.000000 1.000 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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 12000 120 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 13013 200 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 - babyf ood 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 1 5000650 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 1.0 00 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 150023 10 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 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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, flo ur - 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 0.020 000 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 1 5 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 l eaves - 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 1 9013340 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 1.0 00 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 Flaxs eed, 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 200036 51 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, liv er - 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 0.050 000 1.000 1.000 23001720 M Goat, kidney 0.050000 1.000 1.000 23001730 M Goat, liver 0.050000 1.000 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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 s olids - 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 Gr ape, 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 1.000 950 02110 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 Pome granate 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 95 003600 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 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Page 17 of 25 

### Attachment 2: DEEM - FCID TM 

### 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 (Acut e) = 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 163Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Page 18 of 25 

### Attachment 3: DEEM - FCID TM 

### Chronic Residue File Filename: C: \ Documents and Settings \ gkramer \ My Documents \ Gk \ ##Fludioxonil \ 20 12_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 0101053 1 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 0.75000 0 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 1.8 20000 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 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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 Onio n, 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 3 0.000000 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 04011 340 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

Fu ll 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 5 A 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 Coll ards 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 10.000 000 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 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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 06031 821 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; pr ocessing 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; proces sing 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 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Page 21 of 25 09023561 9B Squash, summer - babyfood 0.45000 0 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, juic e - 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 11 002670 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 1 3A 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 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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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 0.0200 00 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, sy rup 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 Mi llet, 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 15004 010 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 1.000Fludioxonil 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 190120 20 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 0.0200 00 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 23001 730 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; DPFludioxonil 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 5.00 0000 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 Pass ionfruit 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 95002 790 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 St rawberry, 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 1.000Fludioxonil Dietary Exposure and Risk Assessment DP# 389981

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Page 25 of 25 

### Attachment 4: DEEM - FCID TM 

### 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 0.0 07562 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%

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