Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 1 of 11 1

UNITED STATES ENVIRONMEN TAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM

DATE: 10 Sept 2010

SUBJECT: Flutolanil Chronic Aggregate Dietary (F ood and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action ( Brassica Leafy Vegetables, Crop Group 5).

PC Code: 128975 DP Barcode: D371494 Decision No.: 419258 Registration No.: 10163-301 Petition No.: 9E7612 Regulatory Action: Section 3 Registration Risk Assessment Type: Single Chemical/Aggregate Case No.: N/A TXR No.: NA CAS No.: 66332-96-5 MRID Nos. NA 40 CFR: § 180.484

REVIEWER: Kristin Rury, Biologist Risk Assessment Branch 3 Health Effects Division (7509P)

THROUGH: Doug Dotson, Chemist Julie VanAlstine, Environmental Health Scientist Dietary Exposure Science Advisory Council (DESAC) Health Effects Division (7509P) and Paula Deschamp, Branch Chief Risk Assessment Branch 3 Health Effects Division (7509P)

TO: Barbara Madden, Risk Management Team 05 Risk Integration, Minor Use and Emergency Response Branch (RIMUERB) Registration Division (7505P)

Executive Summary

Chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evalua tion Model, DEEM-FCIDTM, Version 2.03,Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 2 of 11 which uses food consumption data from the U. S. Department of Ag riculture’s (USDA’s) Continuing Surveys of Food Intakes by I ndividuals (CSFII) from 1994-1996 and 1998. The analysis was performed to support a S ection 3 request for flutolanil in/on Brassica leafy vegetables (crop group 5) and turnip greens.

Acute Dietary (Food and Drinking Water) Ex posure Results and Characterization

No appropriate endpoint attribut able to a single dose was id entified. As no acute dietary endpoint was identified, an acute ex posure analysis was not performed.

Chronic Dietary (Food and Dr inking Water) Exposure Results and Characterization

Tolerance level residues combined with 100% crop treated and DEEM TM 7.81 default processing factors were used to determine the chronic dietar y exposure and risk estimates. The chronic dietary exposure estimates for f ood and drinking water are below HED’s level of concern for the general U.S. population (1% of th e chronic population adju sted dose (cPAD)). The most highly exposed population subgroup wa s children 1 – 2 (<2% of the cPAD). Drinking water was incorporated dir ectly into the dietary assessment.

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

Flutolanil is classified as “not likely to be carcinogenic to humans,” so a cancer dietary assessment was not conducted

I. Introduction

Dietary risk assessment incorporat es both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expresse d as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the population adju sted dose (PAD). The P AD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required un certainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generally co ncerned when estimated cancer risk exceeds one in one million. References which discuss th e acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link: http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20- AUG-1999).

The most recent dietary risk assessment for flutolanil was conducted by S. Funk (01/04/2010, D364586).Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 3 of 11 II. Residue Information

Flutolanil Use:

For the current action, HED has examined data to support the establishmen t of tolerances in/on
Brassica leafy vegetables and turnip greens.

HED's Metabolism Assessment Review Committee (MARC) met on 12/16/99 and concluded that the parent compound and metabolites c ontaining the common moie ty, 2-trifluoromethyl benzanilide, calculated as flutolanil, are the resi dues of concern for plants and rotational crops. As the enforcement method for plant commod ities converts residues of flutolanil and its metabolites to 2-trifluoromethyl benzoic acid, tole rances for plant commodities will be set in terms of residues of flutolanil and its metabolite s converted to 2-trifluoromethyl benzoic acid, calculated as flutolanil. Th e parent compound and metabolites, M-2, M-4, and M-7, are the residues of concern in animal ti ssues and milk. The glucuronid e/sulfate conjugates of M-4 are also residues of concern in milk. As the enfo rcement analytical method determines residues of flutolanil and metabolites convert ed to 2-trifluoromethyl benzoi c acid, tolerances on livestock commodities are established in terms of parent plus metabolites that are converted to the common moiety (HED MARC M. Xue, 1/6/00; Anna Lowit et al . D268880, 09/11/2000).

Tolerances are currently established for residues of flutolanil and its metabolites converted to 2-trifluoromethyl benzoic acid and calculated as flutolanil in/ on peanut, rice, potato, milk, egg, soybean and cotton commodities, poultry, beef, hog, goat, horse, and sheep (40 CFR§180.484(a)) at levels rang ing from 0.05 ppm to 25.0 ppm. Inadvertent or indirect tolerances are also currently established for residues of flutolanil and its metabolites in/on wheat bran, wheat forage, wheat grain, wh eat hay, and wheat straw commodities (40 CFR§180.484(d)), at levels ranging from 0.2 ppm to 2.5 ppm.

Residue Data Used for Chronic Assessments

The established tolerances in 40 CFR§180.484 and the recommended tolerance levels for
Brassica leafy vegetables and turnip greens (liste d below) were used to conduct the chronic analysis.

Tolerances to be established under “ §180.484 (a) General”:

Vegetable, brassica leafy, group 5 ......................... 0.11 ppm Turnip, Greens ....................................................... 0.11 ppm

DEEM TM 7.81 default processing factors along with 100% crop treated assumptions were used to conduct the chronic analysis.Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 4 of 11 III. Drinking Water Data

The drinking residues used in the dietary asse ssment were provided by the Environmental Fate and Effects Division (EFED) in the followi ng memorandum: “Estimated Environmental Concentrations (EECs) of Flutolanil on Sugar Beets, Brassica Leafy Vegetables, Turnip Greens, and Ginseng” (L. Liu, D370201, 7/21/2010) a nd were incorporated directly into this dietary assessment. Water residues were incorp orated in the DEEM Food Commodity Intake Database (FCID) into the food categories “water, direct, all s ources” and “water, indirect, all sources.”

For surface water and groundwater, Estimated Drinking Water Concentrations (EDWCs) were generated from the Pesticide Root Zone Model and Exposure Analysis Modeling System (PRZM-EXAMs) and from a Tier I Sc reening Concentration In Ground Water (SCIGROW) analysis, respectively. The surface and groundwater ED WCs are shown in Table 1. At the time the EDWCs were generated, flut olanil was proposed for use on sugar beets,
Brassica leafy vegetables, turnip greens and ginse ng, with the highest ap plication rate for flutolanil being on ginseng. The mean su rface water concentration of 8.5 (ppb) from application to ginseng was entered as a conservati ve point estimate in the chronic residue file editor for DEEM-FCID TM . While the proposed use of flutolanil on ginseng has been withdrawn, the drinking water analysis incorpor ating the use of flutolanil on ginseng was used in the dietary assessment as a c onservative, screening level analysis.

Table 1. Recommended Surface and Groundwater Concentrations

Agricultural Setting Surface Water Concentrations Groundwater Concentrations (ppb)

1 in 10 year Peak

EDWC (ppb) 1 in 10 year Annual EDWC (ppb) Ginseng

12.7 8.5 0.7

IV. DEEM-FCIDTM Program and Consumption Information

Flutolanil chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the F ood Commodity Intake Database DEEMFCIDTM,Version 2.03 which incorporates consumpti on data from USDA’s Continuing Surveys of Food Intakes by Individuals (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) ar e linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fr esh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe transl ation files developed jo intly by USDA/ARS and EPA. For chronic exposure assessment, consum ption 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 an alysis 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.Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 5 of 11 population, all infants (<1 year old), childre n 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 esti mate of the residue level in each food or foodform (e.g., orange or orange juice) on the f ood 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 estima te for each food/food form is summed with the residue intake estimates for all other food/food fo rms on the commodity residue list to arrive at the total average estimated expos ure. Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD. This procedur e is performed for each population subgroup.

V. Toxicological Information

The doses and endpoints for dietary risk assessm ent were selected by the flutolanil risk assessment team. A summary of this information is presented in Table 2. Flutolanil has been classified as “not like ly to be carcinogenic to humans.” A quantitative carcinogenic dietary analysis is not required.

Subchronic and chronic toxicity studies showed that the primary effects of flutolanil are increases in liver weight comb ined with decreases in body wei ght. The available data for flutolanil do not show neurotoxic, carcinogenic, or mutagenic effects. Flutolanil is not a developmental or reproductive toxi cant. There is no evidence of increased susceptibility of rat or rabbit fetuses to in-utero exposure or rat pups to post-natal exposure to flutol anil. No toxic effects were observed in studies in which flutolanil was administered by the dermal routes of exposure. The FQPA Safety Factor for flut olanil was reduced to 1X because there was no increased sensitivity to fetuses as compared to maternal animals in the developmental rat and rabbit studies and no increased sensitivity to pups as compared to adults in a multi-generation reproduction study in rats (M. Ottley et al , D349580, 08/07/2008).

The doses and toxicological e ndpoints selected for various e xposure scenarios are summarized below.Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 6 of 11 Table 2: Summary of Toxicological Doses and Endpoints for Flutolanil for Use in Dietary Exposure Risk Assessments Exposure/ Scenario Point of Departure Uncertainty/FQPA Safety Factors RfD, PAD, Level of Concern Study and Toxicological Effects

Acute Dietary (All Populations ) N/A N/A N/A No approp riate endpoint was identified in the oral toxicity studies including developmental toxicity studies in rats and rabbits. This risk assessment is not required.
Chronic Dietary (All Populations) NOAEL= 50 mg/kg/day UF A = 10x
UF H =10x FQPA SF= 1x Chronic RfD = 0.5 mg/kg/day

cPAD = 0.5 mg/kg/day Chronic toxicity in dog LOAEL = 1250 mg/kg/day based on increase of clinical toxic signs (emesis, salivation, and soft stool), lower body weight gains and decreased food consumption ] Cancer (oral, dermal, inhalation) Classification: “Not likely to be Carcinogenic to Humans” based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dos e-response data and used to mark the beginning of extrapolation to determine risk associ ated with lower environmentall y 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 adjusted dose (a = acute, c = chronic). RfD = reference dose.

VI. Results/Discussion

Results of Chronic Dietary (Food an d Drinking Water) Exposure Analysis

As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM-FCIDTM analyses es timate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 3 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adu lts 50+ years. Tolerance level residues, 100% CT, and DEEM TM 7.81 default processing factors were used to determine the chronic dietary exposure and risk estimates. This assessment showed that for all included commodities, the chronic risk estimates were below the Agency’s level of concern (<100% cPAD) for the general U.S. population (<1% of the cPAD) and all population subgroups (<2% cPAD) listed in Table 3. The most highly exposed population subgroup was children 1 – 2 years of age at <2% of the cPAD.Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 7 of 11 Table 3: Summary of Dietary (Food a nd Drinking Water) Exposure and Risk for Flutolanil

Chronic Dietary
Population Subgroup Dietary Exposure (mg/kg/day) % cPAD

General U.S. Population 0.003127 <1

All Infants (< 1 year old) 0.007005 1.4

Children 1-2 years old 0.007530 1.5

Children 3-5 years old 0.006337 1.3

Children 6-12 years old 0.004258 <1

Youth 13-19 years old 0.002850 <1

Adults 20-49 years old 0.002818 <1

Adults 50+ years old 0.001964 <1

Females 13-49 years old 0.002418 <1

VII. Characterizati on of Inputs/Outputs

As the exposure estimates to all population subgroups were low, it was not necessary to make refinements to the chronic dietary analysis. Furt her refinement to the analysis could be made through the use of percent crop treated, anticipated residues, empirical processing factors, and/or monitoring data.

VIII. Conclusions

Based on extremely conservative assumptions , the chronic dietary (food and water) risk estimates are well below HED’s level of con cern for the general U.S. population and all population subgroups, includi ng those comprised of infants and children.

IX. List of Attachments

Attachment 1: Chronic Food and Water Residue Input File. Attachment 2: Chronic Results File.Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 8 of 11 Attachment 1: Chronic Food and Water Residue Input file

Filename: C:\DEEMFCID\Flutolanil\flutolanil Brassica Sept 2010.R98
Chemical: FLUTOLANIL RfD(Chronic): .5 mg/kg bw/day NOEL(Chronic): 50 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 09-09-2010/11:58:32/8 Program ver. 2.03 Comment: update for seed treatment use: cottonseed; soybeans. Sugar beet is non-food
use for seed treatment.

-------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 01032960 1C Potato, chips 0.200000 1.000 1.000 01032970 1C Potato, dry (granules/ flakes) 0.200000 6.500 1.000 01032971 1C Potato, dry (granules/ flakes)-b 0.200000 6.500 1.000 01032980 1C Potato, flour 0.200000 6.500 1.000 01032981 1C Potato, flour-babyfood 0.200000 6.500 1.000 01032990 1C Potato, tuber, w/peel 0.200000 1.000 1.000 01032991 1C Potato, tuber, w/peel-babyfood 0.200000 1.000 1.000 01033000 1C Potato, tuber, w/o peel 0.200000 1.000 1.000 01033001 1C Potato, tuber, w/o peel-babyfood 0.200000 1.000 1.000 05010610 5A Broccoli 0.110000 1.000 1.000 05010611 5A Broccoli-babyfood 0.110000 1.000 1.000 05010620 5A Broccoli, Chinese 0.110000 1.000 1.000 05010640 5A Brussels sprouts 0.110000 1.000 1.000 05010690 5A Cabbage 0.110000 1.000 1.000 05010710 5A Cabbage, Chinese, napa 0.110000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 0.110000 1.000 1.000 05010830 5A Cauliflower 0.110000 1.000 1.000 05011960 5A Kohlrabi 0.110000 1.000 1.000 05020630 5B Broccoli raab 0.110000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 0.110000 1.000 1.000
05021170 5B Collards 0.110000 1.000 1.000
05021940 5B Kale 0.110000 1.000 1.000 05022290 5B Mustard greens 0.110000 1.000 1.000 05023180 5B Rape greens 0.110000 1.000 1.000 05023890 5B Turnip, greens 0.110000 1.000 1.000 06003470 6 Soybean, seed 0.200000 1.000 1.000 06003480 6 Soybean, flour 0.200000 1.000 1.000 06003481 6 Soybean, flour-babyfood 0.200000 1.000 1.000 06003490 6 Soybean, soy milk 0.200000 1.000 1.000 06003491 6 Soybean, soy milk-babyfood or in 0.200000 1.000 1.000 06003500 6 Soybean, oil 0.200000 1.000 1.000 06003501 6 Soybean, oil-babyfood 0.200000 1.000 1.000 15003230 15 Rice, white 7.000000 1.000 1.000 15003231 15 Rice, white-babyfood 7.000000 1.000 1.000 15003240 15 Rice, brown 7.000000 1.000 1.000 15003241 15 Rice, brown-babyfood 7.000000 1.000 1.000 15003250 15 Rice, flour 7.000000 1.000 1.000 15003251 15 Rice, flour-babyfood 7.000000 1.000 1.000 15003260 15 Rice, bran 10.000000 1.000 1.000 15003261 15 Rice, bran-babyfood 10.000000 1.000 1.000 15004010 15 Wheat, grain 0.050000 1.000 1.000 15004011 15 Wheat, grain-babyfood 0.050000 1.000 1.000 15004020 15 Wheat, flour 0.050000 1.000 1.000 15004021 15 Wheat, flour-babyfood 0.050000 1.000 1.000 15004030 15 Wheat, germ 0.050000 1.000 1.000 15004040 15 Wheat, bran 0.200000 1.000 1.000 21000440 M Beef, meat 0.050000 1.000 1.000 21000441 M Beef, meat-babyfood 0.050000 1.000 1.000 21000450 M Beef, meat, dried 0.050000 1.920 1.000Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 9 of 11 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 0.100000 1.000 1.000 21000471 M Beef,fat-babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 1.000000 1.000 1.000 21000490 M Beef, liver 2.000000 1.000 1.000 21000491 M Beef, liver-babyfood 2.000000 1.000 1.000 23001690 M Goat, meat 0.050000 1.000 1.000 23001700 M Goat, meat byproducts 0.050000 1.000 1.000 23001710 M Goat, fat 0.100000 1.000 1.000 23001720 M Goat, kidney 1.000000 1.000 1.000 23001730 M Goat, liver 2.000000 1.000 1.000 24001890 M Horse, meat 0.050000 1.000 1.000 25002900 M Pork, meat 0.050000 1.000 1.000 25002901 M Pork, meat-babyfood 0.050000 1.000 1.000 25002910 M Pork, skin 0.050000 1.000 1.000 25002920 M Pork, meat byproducts 0.050000 1.000 1.000 25002921 M Pork, meat byproducts-babyfood 0.050000 1.000 1.000 25002930 M Pork, fat 0.100000 1.000 1.000 25002931 M Pork, fat-babyfood 0.100000 1.000 1.000 25002940 M Pork, kidney 1.000000 1.000 1.000 25002950 M Pork, liver 2.000000 1.000 1.000 26003390 M Sheep, meat 0.050000 1.000 1.000 26003391 M Sheep, meat-babyfood 0.050000 1.000 1.000 26003400 M Sheep, meat byproducts 0.050000 1.000 1.000 26003410 M Sheep, fat 0.100000 1.000 1.000 26003411 M Sheep, fat-babyfood 0.100000 1.000 1.000 26003420 M Sheep, kidney 1.000000 1.000 1.000 26003430 M Sheep, liver 2.000000 1.000 1.000 27002220 D Milk, fat 0.050000 1.000 1.000 27002221 D Milk, fat - baby food/infant for 0.050000 1.000 1.000 27012230 D Milk, nonfat solids 0.050000 1.000 1.000 27012231 D Milk, nonfat solids-baby food/in 0.050000 1.000 1.000 27022240 D Milk, water 0.050000 1.000 1.000 27022241 D Milk, water-babyfood/infant form 0.050000 1.000 1.000 27032251 D Milk, sugar (lactose)-baby food/ 0.050000 1.000 1.000 40000930 P Chicken, meat 0.050000 1.000 1.000 40000931 P Chicken, meat-babyfood 0.050000 1.000 1.000 40000940 P Chicken, liver 0.050000 1.000 1.000 40000950 P Chicken, meat byproducts 0.050000 1.000 1.000 40000951 P Chicken, meat byproducts-babyfoo 0.050000 1.000 1.000 40000960 P Chicken, fat 0.050000 1.000 1.000 40000961 P Chicken, fat-babyfood 0.050000 1.000 1.000 40000970 P Chicken, skin 0.050000 1.000 1.000 40000971 P Chicken, skin-babyfood 0.050000 1.000 1.000 50003820 P Turkey, meat 0.050000 1.000 1.000 50003821 P Turkey, meat-babyfood 0.050000 1.000 1.000 50003830 P Turkey, liver 0.050000 1.000 1.000 50003831 P Turkey, liver-babyfood 0.050000 1.000 1.000 50003840 P Turkey, meat byproducts 0.050000 1.000 1.000 50003841 P Turkey, meat byproducts-babyfood 0.050000 1.000 1.000 50003850 P Turkey, fat 0.050000 1.000 1.000 50003851 P Turkey, fat-babyfood 0.050000 1.000 1.000 50003860 P Turkey, skin 0.050000 1.000 1.000 50003861 P Turkey, skin-babyfood 0.050000 1.000 1.000 60003010 P Poultry, other, meat 0.050000 1.000 1.000 60003020 P Poultry, other, liver 0.050000 1.000 1.000 60003030 P Poultry, other, meat byproducts 0.050000 1.000 1.000 60003040 P Poultry, other, fat 0.050000 1.000 1.000 60003050 P Poultry, other, skin 0.050000 1.000 1.000 70001450 P Egg, whole 0.050000 1.000 1.000 70001451 P Egg, whole-babyfood 0.050000 1.000 1.000 70001460 P Egg, white 0.050000 1.000 1.000 70001461 P Egg, white (solids)-babyfood 0.050000 1.000 1.000 70001470 P Egg, yolk 0.050000 1.000 1.000Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 10 of 11 70001471 P Egg, yolk-babyfood 0.050000 1.000 1.000 86010000 O Water, direct, all sources 0.008500 1.000 1.000 86020000 O Water, indirect, all sources 0.008500 1.000 1.000 95001280 O Cottonseed, oil 0.200000 1.000 1.000 95001281 O Cottonseed, oil-babyfood 0.200000 1.000 1.000
95002630 O Peanut 0.500000 1.000 1.000 95002640 O Peanut, butter 0.500000 1.890 1.000 95002650 O Peanut, oil 0.500000 1.000 1.000Flutolanil Dietary Exposure and Ri sk Assessment DP Number: 371494 PC Code: 128975

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Page 11 of 11 Attachment 2: Chronic Results File

U.S. Environmental Protection Agency Ver. 2.00 DEEM-FCID Chronic analysis for FLUTOLANIL (1994-98 data) Residue file name: C:\DEEMFCID\Flutolanil\flutolanil Brassica Sept 2010.R98 Adjustment factor #2 NOT used. Analysis Date 09-09-2010/14:07:32 Residue file dated: 09-09-2010/11:58:32/8 Reference dose (RfD, Chronic) = .5 mg/kg bw/day COMMENT 1: Update for brassica use

=============================================================================== Total exposure by population subgroup

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Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.003127 0.6%

U.S. Population (spring season) 0.003156 0.6% U.S. Population (summer season) 0.003192 0.6% U.S. Population (autumn season) 0.003080 0.6% U.S. Population (winter season) 0.003080 0.6%

Northeast region 0.003516 0.7% Midwest region 0.002600 0.5% Southern region 0.002704 0.5% Western region 0.004013 0.8%

Hispanics 0.004847 1.0% Non-hispanic whites 0.002414 0.5% Non-hispanic blacks 0.003209 0.6% Non-hisp/non-white/non-black 0.010478 2.1%

All infants (< 1 year) 0.007005 1.4% Nursing infants 0.003979 0.8% Non-nursing infants 0.008154 1.6% Children 1-6 yrs 0.006613 1.3% Children 7-12 yrs 0.004016 0.8%

Females 13-19 (not preg or nursing) 0.002322 0.5% Females 20+ (not preg or nursing) 0.002131 0.4% Females 13-50 yrs 0.002641 0.5% Females 13+ (preg/not nursing) 0.003501 0.7% Females 13+ (nursing) 0.003121 0.6%

Males 13-19 yrs 0.003339 0.7% Males 20+ yrs 0.002883 0.6% Seniors 55+ 0.001877 0.4%

Children 1-2 yrs 0.007530 1.5% Children 3-5 yrs 0.006337 1.3% Children 6-12 yrs 0.004258 0.9% Youth 13-19 yrs 0.002850 0.6% Adults 20-49 yrs 0.002818 0.6% Adults 50+ yrs 0.001964 0.4% Females 13-49 yrs 0.002418 0.5%

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