F enbuconazole Dietary Exposure and Risk Assessment DP Number: 403621 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: Jan 8, 2013 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Fenbuconazole: Acute, Chronic, and Cancer Aggregate Dietary (Food and 

Drinking Water) Exposure Analysis for the Section 3 Registration Action Increasing 

the Tolerance for Peppers. 

PC Code: 1290 II 

Decision No.: 465307 

Petition No.: 2F8034 

DP Number: 403621 

Registration No.: 62719-421 

Regulatory Action: Section 3 Tolerance 

Amendment 

Risk Assessment Type: Dietary Case No.: 701 2 

TXR No.: None 

MRJD No.: None 

CAS No.: 114369-43-6 

40 CFR: 180.480 

FROM: Dennis McNeilly, Chemist [3 ....----

Registration Action Branch 2 

Health Effects Division (7509P) 

THROUGH~915ouglas Dotson, Ph.D., Chern ~ Kristen Rury, Biologist ·y_ \CS. (_) .. /) 

Michael Doherty, Ph.D., Senior Scientist f~Jt1A.' 

Registration Action Branch 2 

TO: 

Health Effects Division (7509P) 

Erin Malone/Shaja Joyner, RM 20 

Fungicide Branch 

Registration Division (7505P) 

Executive Summary 

Acute, chronic, and cancer aggregate dietary [food and drinking water] exposure and risk 

assessments were conducted using the Dietary Exposure Evaluation Model software with the 

Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 

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F enbuconazole Dietary Exposure and Risk Assessment DP Number: 403621 

food consumption data from the U.S. Department of Agriculture's National Health and Nutrition 

Examination Survey, What We Eat in America, (NHANES/WWEIA). Acute, chronic, and 

cancer aggregate dietary exposure analyses were perfonned in order to support a Section 3 

request for an increased tolerance for fenbuconazole on peppers. 

Acute Dietary Exposure Results and Characterization 

The acute dietary exposure analysis is based on tolerance-level residues and assumes 100% crop 

treated. As such, it is highly conservative with respect to evaluating potential impacts of acute 

dietary exposure to fenbuconazole on human health. The only population subgroup that is 

relevant for this acute assessment is females of child-bearing age (i.e., females 13-49 years old). 

The acute risk estimate that results from this analysis is 2.9% of the acute population adjusted 

dose (aPAD) at the 95th percentile of exposure. This risk estimate is considerably lower than 

HED's level of concern (100% of the aPAD). 

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

The chronic (non-cancer) dietary analysis is more refined because it uses average residues from 

field trials. Because of the manner in which these data were submitted and reviewed, multiple 

averages were calculated for many of the crops. For these crops, the highest average was used in 

the analysis. The non-cancer dietary analysis assumes 1 00% crop treated. The most highly 

exposed population subgroup is Children 1-2 years old which utilizes 6.7% ofthe chronic 

population adjusted dose (cPAD). The risk estimate for the general U.S. population is 2.3% of 

the cPAD. As with the acute assessment, the risk estimates are all well below HED's level of 

concern (100% ofthe cPAD). 

Cancer Dietary Exposure Results and Characterization 

The cancer dietary analysis uses the same food residue inputs as those used in the chronic noncancer assessment. The cancer analysis is further refined in that it makes use of average percent 

crop treated estimates. The cancer risk estimate using these food residue inputs and a worst case 

use pattern assumption for water is 2.2 x 1 o6

• 

The common triazole metabolites 1,2,4-triazole, triazole alanine, and triazole acetic acid have 

been identified as residues of concern for risk assessment. A separate dietary exposure 

assessment has been performed for these metabolites (D350314, T. Morton). As a result, they 

are not being included in this assessment. 

I. Introduction 

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

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose 

(i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to the 

point of departure (e.g., NOAEL, LOAEL) divided by the required uncertainty or safety factors. 

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Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

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For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

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

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

Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link: 

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

(8/20/1999). The last dietary exposure analysis performed for fenbuconazole was done so in 

2008 to support the original tolerance petition for use on peppers (D350321, D. Dotson, 

6/12/2008). 

II. Residue Information

For peppers, the HED-recommended tolerance level of 1.0 ppm was used as the residue value in 

the acute dietary exposure analysis. The average field trial value of 0.19 ppm for peppers was 

used for the chronic and cancer dietary exposure analyses. Residue values used for all other 

commodities are discussed in detail in the previous dietary exposure memo performed for 

fenbuconazole (D350321, D. Dotson, 6/12/2008). Table 1, below, was taken directly from that 

memo (percent crop treated information was updated) and peppers were added. Tolerances for 

fenbuconazole are listed in 40CFR§180.480. 

The petitioner has submitted adequate studies describing residues of fenbuconazole and its 

residues of concern in almonds, apples, bananas, blueberries, citrus, cranberries, grapes, peanuts, 

pecans, peppers, stone fruit, sugar beets, and wheat. Residue estimates for the chronic and cancer

assessments are based on all of the submitted data (often from slightly exaggerated rate studies). 

The residue estimates used in these assessments are directly from the field trial data and, by 

nature of the analytical methods, account for all of the fenbuconazole-specific residues of 

concern in crops and livestock [fenbuconazole, lactone metabolites RH-9129 and RH-9130, and 

the hydroxyl metabolite RH-4911 (peanuts only) and its glycosyl conjugate RH-7905 (peanuts 

only); but not the common triazole metabolites]. A separate dietary exposure assessment has 

been performed for the common triazole metabolites (D350314, T. Morton). Crop field trials 

with the above-listed commodities resulted in measurable residues of concern for all crops. The 

residues are summarized in Table 1, and complete listings of the residue estimates are included 

as Attachments 1, 3, and 5 (acute, chronic non-cancer, and cancer assessments, respectively).

Acute Assessment. The acute dietary (food + water) assessment is a screening-level assessment. 

It is based on single-point, tolerance-level residue estimates for all foods, assumes 100% crop 

treated, and uses the acute estimated drinking water concentrations (EDWC) for fenbuconazole 

in surface water (24.1 ppb), which is a high-end estimate that is derived from the requested use 

pattern for peppers. The acute assessment includes DEEMTM Version 7.81 default processing 

factors for those commodities that were not addressed by the available processing studies. For 

commodities where there is data indicating that residues do not concentrate during processing, a 

factor of one was used to be conservative.

Chronic (Non-cancer) and Cancer Assessments. The chronic (non-cancer) and cancer dietary 

assessments include contributions from both food and water. The chronic estimated drinking 

water concentrations (EDWC) for fenbuconazole is the 1-in-10-year annual mean surface water 
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

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value of 16.5 ppb in surface water, which is a high-end estimate derived from the use on cherries. 

The cancer estimated drinking water concentrations (EDWC) for fenbuconazole is the 

30-year annual mean surface water value of 11.7 ppb for cherries, which is also a high-end

estimate derived from the use on cherries. For many of the crops, residue data were submitted in 

multiple volumes, and summary statistics for those data were computed for each volume. HED 

selected the highest per-study-volume average as the food residue estimate in the chronic 

assessments. For example, three volumes of field trial data were submitted for oranges, and an 

average residue value was determined for the data within each volume. The highest of these 

three averages is used in the chronic assessments. The chronic assessments use DEEMTM version 

7.81 default processing factors for commodities that do not have empirical processing factors. 

The non-cancer assessment assumes 100% crop treated, whereas the cancer assessment makes 

use of average percent-crop-treated estimates. These estimates were provided by the Biological 

and Economic Analysis Division (see Attachment 7).

Table 1. Summary of Residues and Factors Used in the Acute, Chronic, and Cancer Dietary Assessments for Fenbuconazole. 

Food Name Acute 

Residue 

Estimate

(Tolerance)

(ppm)

Acute 

Processing 

Factor

Chronic 

Residue 

Estimate

(ppm)

Chronic 

Processing 

Factor

% Crop 

Treated

(Avg.)

Remarks for Chronic and Cancer 

Assessment

Almond 0.05 1 0.015 1 5

Almond, oil 0.05 1 0.015 1 5

Apple, fruit with peel 0.4 1 0.142 1 5

Apple, peeled fruit 0.4 1 0.142 1 5

Apple, dried 0.4 8 0.142 8 5 Default Proc. Factor

Apple, juice 0.4 1 0.142 0.059 5 Empirical Proc. Factor

Apple, sauce 0.4 1 0.142 1 5

Apricot 1 1 0.307 1 5 Average Peach Value

Apricot, dried 1 6 0.307 6 5 Default Proc. Factor

Apricot, juice 1 1 0.307 1 5

Banana 0.3 1 0.028 1 100

Banana, dried 0.3 3.9 0.028 3.9 100 Default Proc. Factor

Beef, meat byproducts 0.05 1 0.05 1 100

Beet, sugar 0.3 1 0.061 1 1

Beet, sugar, molasses 0.4 1 0.061 1.8 1 Empirical Proc. Factor

Blueberry 0.3 1 0.3 1 55

Cherry 1 1 0.336 1 15

Cherry, juice 1 1 0.336 1.0 15 No concentration in juice

Citrus citron 1 1 0.073 1 100 Lemon Pulp

Citrus hybrids 1 1 0.073 1 100 Lemon Pulp

Citrus, oil 40 1 0.073 47 100 Lemon Pulp + Empirical Proc. Factor

Cranberry 0.5 1 0.199 1 100

Cranberry, dried 0.5 1 0.199 1 100

Cranberry, juice 0.5 1.1 0.199 1.1 100 Default Processing Factor

Currant 0.3 1 0.093 1 100

Currant, dried 0.3 1 0.093 1 100

Elderberry 0.3 1 0.093 1 100

Goat, meat byproducts 0.05 1 0.05 1 100

Gooseberry 0.3 1 0.093 1 100

Grape 1 1 0.39 1 100

Grape, juice 1 1 0.39 0.18 100 Empirical Proc. Factor
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

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Table 1. Summary of Residues and Factors Used in the Acute, Chronic, and Cancer Dietary Assessments for Fenbuconazole. 

Food Name Acute 

Residue 

Estimate

(Tolerance)

(ppm)

Acute 

Processing 

Factor

Chronic 

Residue 

Estimate

(ppm)

Chronic 

Processing 

Factor

% Crop 

Treated

(Avg.)

Remarks for Chronic and Cancer 

Assessment

Grape, leaves 1 1 0.39 1 100

Grape, raisin 1 4.3 0.39 4.3 100 Default Proc. Factor

Grape, wine and sherry 1 1 0.39 0.7 100 Empirical Proc. Factor

Grapefruit 1 1 0.016 1 40

Grapefruit, juice 1 1 0.016 0.2 40 Citrus Juice Proc. Factor (chronic)

Huckleberry 0.3 1 0.093 1 100

Kumquat 1 1 0.073 1 100

Lemon 1 1 0.073 1 100

Lemon, juice 1 1 0.073 0.2 100 Citrus Juice Proc. Factor (chronic)

Lemon, peel 1 1 0.652 1 100

Lime 1 1 0.073 1 100

Lime, juice 1 1 0.073 0.2 100 Citrus Juice Proc. Factor (chronic)

Nectarine 1 1 0.307 1 5

Orange 1 1 0.017 1 5

Orange, juice 1 1 0.017 0.2 5 Citrus Juice Proc. Factor (chronic)

Orange, peel 1 1 0.652 1 5

Peach 1 1 0.307 1 15

Peach, dried 1 7 0.307 7 15 Default Processing Factor

Peach, juice 1 1 0.307 1.0 15

Peanut 0.1 1 0.035 1 100

Peanut, butter 0.1 1.89 0.035 1.89 100 Default Processing Factor

Peanut, oil 0.1 1 0.035 1 100

Pecan 0.05 1 0.015 1 10

Peppers 1.0 1 0.19 1 100

Plantain 0.3 1 0.028 1 100

Plantain, dried 0.3 3.9 0.028 3.9 100 Default Processing Factor

Plum 1 1 0.063 1 1

Plum, prune, fresh 1 1 0.063 1 1

Plum, prune, dried 1 5 0.063 3.4 1 Default/Empirical Proc. Factors

Plum, prune, juice 1 1 0.063 1.0 1 No concentration in juice

Pummelo 1 1 1 1 100

Sheep, meat byproducts 0.05 1 0.05 1 100

Tangerine 1 1 0.073 1 1 Lemon Pulp

Tangerine, juice 1 1 0.073 0.2 1 Lemon Pulp + Citrus Juice Proc Factor

Wheat, grain 0.1 1 0.017 1 100

Wheat, flour 0.1 1 0.017 0.15 100 Empirical Processing Factor

Wheat, germ 0.1 1 0.017 0.85 100 Empirical Processing Factor

Wheat, bran 0.1 1 0.017 1.4 100 Empirical Processing Factor

III. Percent Crop Treated Information - see Attachment 7.

The acute and chronic assessments are based on 100% crop treated assumptions for all 

commodities.
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

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The following maximum percent crop treated estimates (BEAD Reference) were used in the 

cancer dietary risk assessment for the following crops that are currently registered for 

fenbuconazole: almonds: 5%, Apples: 5%, apricots: 5%, blueberries: 55%, cherries: 15%, 

grapefruit: 40%, nectarines: 5%, oranges: 5%, peaches: 15%, pecans: 10%, plums/prunes: 1%, 

sugar beets: 1%, tangelos: 10%, tangerines: 1%. 

IV. Drinking Water Data

The estimated drinking water concentrations (EDWCs) used in the dietary risk assessments were

provided by the Environmental Fate and Effects Division (EFED, D344352, J. Lin, 1/16/2008). 

The EDWCs were incorporated directly into these dietary assessments in the food categories 

“water, direct, all sources” and “water, indirect, all sources.” The EDWCs for fenbuconazole

were generated with the coupled models PRZM and EXAMS for surface water and SCI-GROW 

for groundwater. Modeled surface water EDWCs are based on the maximum label application 

rate to peppers (acute value) or cherries (chronic and cancer values). The groundwater EDWC is 

based on the maximum label application rate to cherries. These EDWCs reflect concentrations 

of fenbuconazole-specific residues. The common triazole metabolites 1,2,4-triazole, triazole 

alanine, and triazole acetic acid have separate EDWCs and are not being included in this 

assessment.

The PRZM/EXAMS 1-in-10-year annual peak surface water value of 24.1 ppb for peppers is 

greater than the SCI-GROW groundwater value of 0.031 ppb. As a result, the surface water 

value was used in the acute dietary analysis. The 1-in-10-year annual mean surface water value 

of 16.5 ppb for cherries is greater than the groundwater value of 0.031 ppb. As a result, the 

surface water value was used in the chronic dietary analysis. Finally, the 30-year annual mean 

surface water value of 11.7 ppb for cherries is greater than the groundwater value of 0.031 ppb. 

As a result, the surface water value was used in the cancer dietary analysis. The SCI-GROW 

Model and its description are available at the EPA internet site: 

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

V. DEEM-FCIDTM Program and Consumption Information

Fenbuconazole acute and chronic dietary exposure assessments were conducted using the Dietary 

Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, 

Version 3.16, which incorporates 2003-2008 consumption data from USDA’s 

NHANES/WWEIA. The data are based on the reported consumption of more than 20,000 

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

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

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

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

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

exposure assessment, consumption data are retained as individual consumption events. Based on 

analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns 

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

following population subgroups: the general U.S. population, all infants (<1 year old), children 1-
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

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2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years

old.

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

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

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

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

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

cPAD. This procedure is performed for each population subgroup.

For an acute exposure assessment, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food item can be 

multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a 

deterministic exposure assessment, or “matched” in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating 

relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant 

commodities as well as those who did not) basis. In accordance with HED policy, per capita 

exposure and risk are reported for analyses performed at all levels of refinement. However, for 

deterministic assessments, any significant differences in user vs. per capita exposure and risk are 

specifically identified and noted in the risk assessment.

VI. Toxicological Information

The toxicological doses and endpoints for use in fenbuconazole dietary assessments are 

summarized in Table 2.

Table 2. Summary of Toxicological Doses and Endpoints for Use in Dietary Human Health Risk Assessments for 

Fenbuconazole

Exposure

Scenario

Dose Used in Risk 

Assessment, UF 

POD

FQPA SF and Level of 

Concern for Risk 

Assessment

Study and Toxicological Effects

Acute Dietary

(Females 13-49 

years of age)

NOAEL = 30 

mg/kg/day

UFA= 10x

UFH= 10x

Acute RfD = 0.3 

mg/kg

FQPA SF =1

aPAD = acute RfD

 FQPA SF

= 0.3 mg/kg

Developmental rat study

Developmental LOAEL = 75 mg/kg/day 

based on increased resorptions and 

decreased live fetuses per dam.

Acute Dietary 

(General population 

including infants and 

children)

None None Not selected.

No appropriate dose and endpoint could 

be identified for these population 

groups.

Chronic Dietary

(All populations)

NOAEL= 3 

mg/kg/day

UFA= 10x

UFH= 10x

FQPA SF =1

cPAD = 

chronic RfD

FQPA SF

Combined chronic toxicity/ 

carcinogenicity - Rat

LOAEL = 30.6/43.1 (M/F) mg/kg/day 
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

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Chronic RfD = 0.03 

mg/kg/day

= 0.03 mg/kg/day

based on decreased body weight gain, 

increased thyroid weight, and 

histopathological lesions in the liver and 

thyroid gland

Cancer (oral, dermal, 

inhalation)

Classification: Under the 1986 cancer classification scheme, fenbuconazole was classified 

as a Group C - Possible Human Carcinogen, with a low dose extrapolation model applied 

to the animal data for the quantification of human risk (Q1*). This classification was based 

on increased incidence of hepatocellular adenomas and carcinomas in male and female 

mice and of thyroid follicular adenomas and combined adenomas/carcinomas in male rats. 

Based on mechanistic data, quantification of risk was derived using combined 

hepatocellular adenomas/carcinomas in female mice. The upper bound estimate of unit 

risk, Q1* (mg/kg/day)-1is 3.59 x 10-3in human equivalents. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and 

used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human 

exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = 

uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity 

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

adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

VII. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure of the U.S. 

population and various population subgroups. The results of the acute dietary exposure analysis 

for the population subgroup Females 13-49 are reported in Table 3. Table 4 lists the results of 

the chronic and cancer dietary exposure analyses, along with the results of the acute analysis at 

the regulated percentile of exposure (i.e., the 95th). Table 4 lists the results for the general U.S. 

Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, 

females 13-49, adults 20-49, and adults 50-99 years. Cancer risk is determined for the general 

U.S. population only.

Results of Acute Dietary Exposure Analysis

The results of the acute dietary exposure analysis at the 95th, 99th, and 99.9th percentiles of 

exposure are reported in Table 3. As percent crop treated estimates were not used in the 

assessment, HED recommends that the 95th percentile of exposure be used for regulation. The 

population subgroup Females 13-49 utilizes 2.9% of the aPAD at the 95th percentile of exposure. 

Table 3. Results of Acute Dietary Exposure Analysis (Food and Drinking Water)

Population Subgroup

aPAD 

(mkd)*

95th Percentile 99th Percentile 99.9th Percentile

Exposure 

(mkd)

% 

aPAD

Exposure 

(mkd)

% 

aPAD

Exposure 

(mkd)

% 

aPAD

Females 13-49 years old 0.30 0.008618 2.9 0.013971 4.66 0.026168 8.72

*mkd: milligram per kilogram body weight per day
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

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Results of Chronic Dietary Exposure Analysis

In the chronic dietary exposure analysis, the most highly exposed population subgroup is children 

1-2 years old which utilizes 6.7% of the cPAD (Table 4). The general U.S. population utilizes 

2.3% of the cPAD.

Results of Cancer Dietary Exposure Analysis

Cancer risk is determined for the general U.S. population only. Applying the Q* value of 

0.00359 (mg/kg/day)-1to the exposure value of 0.000604 mg/kg/day yields a cancer risk estimate 

of 2.2 x 10-6(Table 4).

Table 4. Summary of Dietary Exposure and Risk for Fenbuconazole (Food and Drinking Water)

Population Subgroup*

Acute Dietary

(95th Percentile) Chronic Dietary Cancer

Dietary 

Exposure 

(mg/kg/day) % aPAD

Dietary 

Exposure

(mg/kg/day) % cPAD

Dietary 

Exposure

(mg/kg/day) Risk

General U.S. Population N/A N/A 0.000705 2.3 0.000604 2.2 x 10-6

All Infants (< 1 year old) N/A N/A 0.001755 5.8

Children 1-2 years old N/A N/A 0.002018 6.7

Children 3-5 years old N/A N/A 0.001410 4.7

Children 6-12 years old N/A N/A 0.000796 2.7

Youth 13-19 years old N/A N/A 0.000458 1.5

Adults 20-49 years old N/A N/A 0.000587 2.0

Adults 50-99 years old N/A N/A 0.000652 2.2

Females 13-49 years old 0.008618 2.9 0.000602 2.0

VIII.Characterization of Inputs/Outputs

In the acute and chronic (non-cancer) dietary exposure analyses, conservative estimates of food 

residue levels and drinking water concentrations were used. In addition, it was assumed that 

100% of the commodities with fenbuconazole tolerances would be treated. Further refinements 

could be made to these analyses, but they are not necessary at the present time.

Several refinements were made to the cancer dietary exposure analysis, however. As explained 

in the residue information section of this memo, for many crops, the highest per-study-volume 

average field trial residue values were used for the residue estimates. The tolerance level was 

used for peppers. Field trials were performed using the maximum application rate (and in some 

cases, slightly exaggerated rates) and the samples were collected at the minimum PHI specified 

on the label. For economic reasons, farmers often do not use the maximum label rates. They use 

the minimum amount of pesticide necessary to obtain the desired results. From extensive past 

experience, HED has observed that monitoring data are much lower in magnitude than field trial 

data. As a result, as monitoring data become available for more of the registered and proposed 

commodities, any future dietary analyses for fenbuconazole would likely produce lower risk 

estimates than does the current analysis. The analyses could also be further refined by the 

translation of processing factors. For example, the citrus juice processing factor could have been 
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

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translated to some of the other juices such as cherry, peach, prune, and cranberry juice. In 

addition, percent crop treated could be incorporated for additional commodities not provided for 

in the Screening Level Estimates of Agricultural Uses (SLUA), especially for grapes (including 

raisins) and bananas.
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IX. Conclusions

Based on conservative assumptions, the acute dietary risk estimate for the population subgroup 

Females 13-49 is well below HED’s level of concern. The chronic (non-cancer) dietary risk 

estimates are also based on conservative assumptions and are well below HED’s level of 

concern. Finally, the cancer dietary risk estimate for the general U.S. population is conservative 

and also below HED’s level of concern.

X. List of Attachments:

Attachment 1: Residue Input File for Acute Analysis

Attachment 2: Results of Acute Dietary Exposure Analysis

Attachment 3: Residue Input File for Chronic (Non-Cancer) Analysis

Attachment 4: Results of Chronic Dietary Exposure Analysis

Attachment 5: Residue Input File for Cancer Analysis

Attachment 6: Results of Cancer Dietary Exposure Analysis

Attachment 7: Screening Level Usage Analysis (SLUA)
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

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Attachment 1: Residue Input File for Acute Analysis

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Acute analysis for FENBUCONAZOLE

Residue file name: J:\Fenbuconazole\FENBUCONAC.R08

Analysis Date 11-14-2012 Residue file dated: 11-14-2012/07:46:40

Reference dose (aRfD) = 0.3 mg/kg bw/day

Comment: RfDs are PADs and acute value is for females 13-49 only

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Food Name (ppm) #1 #2 

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

1400003000 14 Almond 0.050000 1.000 1.000

1400003001 14 Almond-babyfood 0.050000 1.000 1.000

1400004000 14 Almond, oil 0.050000 1.000 1.000

1400004001 14 Almond, oil-babyfood 0.050000 1.000 1.000

1100007000 11 Apple, fruit with peel 0.400000 1.000 1.000

1100008000 11 Apple, peeled fruit 0.400000 1.000 1.000

1100008001 11 Apple, peeled fruit-babyfood 0.400000 1.000 1.000

1100009000 11 Apple, dried 0.400000 8.000 1.000

1100009001 11 Apple, dried-babyfood 0.400000 8.000 1.000

1100010000 11 Apple, juice 0.400000 1.000 1.000

1100010001 11 Apple, juice-babyfood 0.400000 1.000 1.000

1100011000 11 Apple, sauce 0.400000 1.000 1.000

1100011001 11 Apple, sauce-babyfood 0.400000 1.000 1.000

1202012000 12B Apricot 1.000000 1.000 1.000

1202012001 12B Apricot-babyfood 1.000000 1.000 1.000

1202013000 12B Apricot, dried 1.000000 6.000 1.000

1202014000 12B Apricot, juice 1.000000 1.000 1.000

1202014001 12B Apricot, juice-babyfood 1.000000 1.000 1.000

9500023000 O Banana 0.300000 1.000 1.000

9500023001 O Banana-babyfood 0.300000 1.000 1.000

9500024000 O Banana, dried 0.300000 3.900 1.000

9500024001 O Banana, dried-babyfood 0.300000 3.900 1.000

3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000

3100046001 31 Beef, meat byproducts-babyfood 0.050000 1.000 1.000

0101052000 1A Beet, sugar 0.300000 1.000 1.000

0101052001 1A Beet, sugar-babyfood 0.300000 1.000 1.000

0101053000 1A Beet, sugar, molasses 0.400000 1.000 1.000

0101053001 1A Beet, sugar, molasses-babyfood 0.400000 1.000 1.000

1302057000 13B Blueberry 0.300000 1.000 1.000

1302057001 13B Blueberry-babyfood 0.300000 1.000 1.000

1201090000 12A Cherry 1.000000 1.000 1.000

1201090001 12A Cherry-babyfood 1.000000 1.000 1.000

1201091000 12A Cherry, juice 1.000000 1.000 1.000

1201091001 12A Cherry, juice-babyfood 1.000000 1.000 1.000

1001106000 10A Citron 1.000000 1.000 1.000

1001107000 10A Citrus hybrids 1.000000 1.000 1.000

1001108000 10A Citrus, oil 40.000000 1.000 1.000

1307130000 13G Cranberry 0.500000 1.000 1.000

1307130001 13G Cranberry-babyfood 0.500000 1.000 1.000

1307131000 13G Cranberry, dried 0.500000 1.000 1.000

1307132000 13G Cranberry, juice 0.500000 1.100 1.000

1307132001 13G Cranberry, juice-babyfood 0.500000 1.100 1.000

1302136000 13B Currant 0.300000 1.000 1.000

1302137000 13B Currant, dried 0.300000 1.000 1.000

1302149000 13B Elderberry 0.300000 1.000 1.000

3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000

1302174000 13B Gooseberry 0.300000 1.000 1.000

1304175000 13D Grape 1.000000 1.000 1.000
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

Page 13 of 21

1304176000 13D Grape, juice 1.000000 1.000 1.000

1304176001 13D Grape, juice-babyfood 1.000000 1.000 1.000

9500177000 O Grape, leaves 1.000000 1.000 1.000

9500178000 O Grape, raisin 1.000000 4.300 1.000

1304179000 13D Grape, wine and sherry 1.000000 1.000 1.000

1003180000 10C Grapefruit 1.000000 1.000 1.000

1003181000 10C Grapefruit, juice 1.000000 1.000 1.000

1302191000 13B Huckleberry 0.300000 1.000 1.000

1002197000 10B Kumquat 1.000000 1.000 1.000

1002199000 10B Lemon 1.000000 1.000 1.000

1002200000 10B Lemon, juice 1.000000 1.000 1.000

1002200001 10B Lemon, juice-babyfood 1.000000 1.000 1.000

1002201000 10B Lemon, peel 1.000000 1.000 1.000

1002206000 10B Lime 1.000000 1.000 1.000

1002207000 10B Lime, juice 1.000000 1.000 1.000

1002207001 10B Lime, juice-babyfood 1.000000 1.000 1.000

1202230000 12B Nectarine 1.000000 1.000 1.000

1001240000 10A Orange 1.000000 1.000 1.000

1001241000 10A Orange, juice 1.000000 1.000 1.000

1001241001 10A Orange, juice-babyfood 1.000000 1.000 1.000

1001242000 10A Orange, peel 1.000000 1.000 1.000

1202260000 12B Peach 1.000000 1.000 1.000

1202260001 12B Peach-babyfood 1.000000 1.000 1.000

1202261000 12B Peach, dried 1.000000 7.000 1.000

1202261001 12B Peach, dried-babyfood 1.000000 7.000 1.000

1202262000 12B Peach, juice 1.000000 1.000 1.000

1202262001 12B Peach, juice-babyfood 1.000000 1.000 1.000

9500263000 O Peanut 0.100000 1.000 1.000

9500264000 O Peanut, butter 0.100000 1.890 1.000

9500265000 O Peanut, oil 0.100000 1.000 1.000

1400269000 14 Pecan 0.050000 1.000 1.000

0802270000 8B Pepper, bell 1.000000 1.000 1.000

0802270001 8B Pepper, bell-babyfood 1.000000 1.000 1.000

0802271000 8B Pepper, bell, dried 1.000000 1.000 1.000

0802271001 8B Pepper, bell, dried-babyfood 1.000000 1.000 1.000

0802272000 8BC Pepper, nonbell 1.000000 1.000 1.000

0802272001 8BC Pepper, nonbell-babyfood 1.000000 1.000 1.000

0802273000 8BC Pepper, nonbell, dried 1.000000 1.000 1.000

9500283000 O Plantain 0.300000 1.000 1.000

9500284000 O Plantain, dried 0.300000 3.900 1.000

1203285000 12C Plum 1.000000 1.000 1.000

1203285001 12C Plum-babyfood 1.000000 1.000 1.000

1203286000 12C Plum, prune, fresh 1.000000 1.000 1.000

1203286001 12C Plum, prune, fresh-babyfood 1.000000 1.000 1.000

1203287000 12C Plum, prune, dried 1.000000 5.000 1.000

1203287001 12C Plum, prune, dried-babyfood 1.000000 5.000 1.000

1203288000 12C Plum, prune, juice 1.000000 1.000 1.000

1203288001 12C Plum, prune, juice-babyfood 1.000000 1.000 1.000

1003307000 10C Pummelo 1.000000 1.000 1.000

3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000

1001369000 10A Tangerine 1.000000 1.000 1.000

1001370000 10A Tangerine, juice 1.000000 1.000 1.000

8601000000 86A Water, direct, all sources 0.024100 1.000 1.000

8602000000 86B Water, indirect, all sources 0.024100 1.000 1.000

1500401000 15 Wheat, grain 0.100000 1.000 1.000

1500401001 15 Wheat, grain-babyfood 0.100000 1.000 1.000

1500402000 15 Wheat, flour 0.100000 1.000 1.000

1500402001 15 Wheat, flour-babyfood 0.100000 1.000 1.000

1500403000 15 Wheat, germ 0.100000 1.000 1.000

1500404000 15 Wheat, bran 0.100000 1.000 1.000
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

Page 14 of 21

Attachment 2: Results of Acute Dietary Exposure Analysis

US EPA Ver. 3.16, 03-08-d

DEEM-FCID ACUTE Analysis for FENBUCONAZOLE NHANES 2003-2008 2-Day

Residue file: FENBUCONAC.R08 Adjustment factor #2 NOT used.

Analysis Date: 11-01-2012/13:08:52 Residue file dated: 11-01-2012/13:07:34

RAC/FF intake summed over 24 hours

Run Comment: "RfDs are PADs and acute value is for females 13-49 only"

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

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

 Exposure % aRfD Exposure % aRfD Exposure % aRfD 

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

Female 13-49:

 0.008618 2.87 0.013971 4.66 0.026168 8.72 
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

Page 15 of 21

Attachment 3: Residue Input File for Chronic (Non-Cancer) Analysis

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for FENBUCONAZOLE

Residue file: J:\Fenbuconazole\FENBUCONCHR.R08 Adjust. #2 NOT used

Analysis Date 11-28-2012 Residue file dated: 11-28-2012/09:31:20

Reference dose (RfD) = 0.03 mg/kg bw/day

Comment:RfDs are PADs and acute value is for females 13-49 only

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

Food Crop Residue Adj.Factors

EPA Code Grp Food Name (ppm) #1 #2 

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

1400003000 14 Almond 0.015000 1.000 1.000 

1400003001 14 Almond-babyfood 0.015000 1.000 1.000 

1400004000 14 Almond, oil 0.015000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.015000 1.000 1.000 

1100007000 11 Apple, fruit with peel 0.142000 1.000 1.000 

1100008000 11 Apple, peeled fruit 0.142000 1.000 1.000 

1100008001 11 Apple, peeled fruit-babyfood 0.142000 1.000 1.000 

1100009000 11 Apple, dried 0.142000 8.000 1.000 

1100009001 11 Apple, dried-babyfood 0.142000 8.000 1.000 

1100010000 11 Apple, juice 0.142000 0.059 1.000 

1100010001 11 Apple, juice-babyfood 0.142000 0.059 1.000 

1100011000 11 Apple, sauce 0.142000 1.000 1.000 

1100011001 11 Apple, sauce-babyfood 0.142000 1.000 1.000 

1202012000 12B Apricot 0.307000 1.000 1.000 

1202012001 12B Apricot-babyfood 0.307000 1.000 1.000 

1202013000 12B Apricot, dried 0.307000 6.000 1.000 

1202014000 12B Apricot, juice 0.307000 1.000 1.000 

1202014001 12B Apricot, juice-babyfood 0.307000 1.000 1.000 

9500023000 O Banana 0.028000 1.000 1.000 

9500023001 O Banana-babyfood 0.028000 1.000 1.000 

9500024000 O Banana, dried 0.028000 3.900 1.000 

9500024001 O Banana, dried-babyfood 0.028000 3.900 1.000 

3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.050000 1.000 1.000 

0101052000 1A Beet, sugar 0.061000 1.000 1.000 

0101052001 1A Beet, sugar-babyfood 0.061000 1.000 1.000 

0101053000 1A Beet, sugar, molasses 0.061000 1.800 1.000 

0101053001 1A Beet, sugar, molasses-babyfood 0.061000 1.800 1.000 

1302057000 13B Blueberry 0.300000 1.000 1.000 

1302057001 13B Blueberry-babyfood 0.300000 1.000 1.000 

1201090000 12A Cherry 0.336000 1.000 1.000 

1201090001 12A Cherry-babyfood 0.336000 1.000 1.000 

1201091000 12A Cherry, juice 0.336000 1.000 1.000 

1201091001 12A Cherry, juice-babyfood 0.336000 1.000 1.000 

1001106000 10A Citron 0.073000 1.000 1.000 

1001107000 10A Citrus hybrids 0.073000 1.000 1.000 

1001108000 10A Citrus, oil 0.073000 47.000 1.000 

1307130000 13G Cranberry 0.199000 1.000 1.000 

1307130001 13G Cranberry-babyfood 0.199000 1.000 1.000 

1307131000 13G Cranberry, dried 0.199000 1.000 1.000 

1307132000 13G Cranberry, juice 0.199000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 0.199000 1.100 1.000 

1302136000 13B Currant 0.093000 1.000 1.000 

1302137000 13B Currant, dried 0.093000 1.000 1.000 

1302149000 13B Elderberry 0.093000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 

1302174000 13B Gooseberry 0.093000 1.000 1.000 

1304175000 13D Grape 0.390000 1.000 1.000 
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

Page 16 of 21

1304176000 13D Grape, juice 0.390000 0.180 1.000 

1304176001 13D Grape, juice-babyfood 0.390000 0.180 1.000 

9500177000 O Grape, leaves 0.390000 1.000 1.000 

9500178000 O Grape, raisin 0.390000 4.300 1.000 

1304179000 13D Grape, wine and sherry 0.390000 0.700 1.000 

1003180000 10C Grapefruit 0.016000 1.000 1.000 

1003181000 10C Grapefruit, juice 0.016000 0.200 1.000 

1302191000 13B Huckleberry 0.093000 1.000 1.000 

1002197000 10B Kumquat 0.073000 1.000 1.000 

1002199000 10B Lemon 0.073000 1.000 1.000 

1002200000 10B Lemon, juice 0.073000 0.200 1.000 

1002200001 10B Lemon, juice-babyfood 0.073000 0.200 1.000 

1002201000 10B Lemon, peel 0.652000 1.000 1.000 

1002206000 10B Lime 0.073000 1.000 1.000 

1002207000 10B Lime, juice 0.073000 0.200 1.000 

1002207001 10B Lime, juice-babyfood 0.073000 0.200 1.000 

1202230000 12B Nectarine 0.307000 1.000 1.000 

1001240000 10A Orange 0.017000 1.000 1.000 

1001241000 10A Orange, juice 0.017000 0.200 1.000 

1001241001 10A Orange, juice-babyfood 0.017000 0.200 1.000 

1001242000 10A Orange, peel 0.652000 1.000 1.000 

1202260000 12B Peach 0.307000 1.000 1.000 

1202260001 12B Peach-babyfood 0.307000 1.000 1.000 

1202261000 12B Peach, dried 0.307000 7.000 1.000 

1202261001 12B Peach, dried-babyfood 0.307000 7.000 1.000 

1202262000 12B Peach, juice 0.307000 1.000 1.000 

1202262001 12B Peach, juice-babyfood 0.307000 1.000 1.000 

9500263000 O Peanut 0.035000 1.000 1.000 

9500264000 O Peanut, butter 0.035000 1.890 1.000 

9500265000 O Peanut, oil 0.035000 1.000 1.000 

1400269000 14 Pecan 0.015000 1.000 1.000 

0802270000 8B Pepper, bell 0.190000 1.000 1.000 

0802270001 8B Pepper, bell-babyfood 0.190000 1.000 1.000 

0802271000 8B Pepper, bell, dried 0.190000 1.000 1.000 

0802271001 8B Pepper, bell, dried-babyfood 0.190000 1.000 1.000 

0802272000 8BC Pepper, nonbell 0.190000 1.000 1.000 

0802272001 8BC Pepper, nonbell-babyfood 0.190000 1.000 1.000 

0802273000 8BC Pepper, nonbell, dried 0.190000 1.000 1.000 

9500283000 O Plantain 0.028000 1.000 1.000 

9500284000 O Plantain, dried 0.028000 3.900 1.000 

1203285000 12C Plum 0.063000 1.000 1.000 

1203285001 12C Plum-babyfood 0.063000 1.000 1.000 

1203286000 12C Plum, prune, fresh 0.063000 1.000 1.000 

1203286001 12C Plum, prune, fresh-babyfood 0.063000 1.000 1.000 

1203287000 12C Plum, prune, dried 0.063000 3.400 1.000 

1203287001 12C Plum, prune, dried-babyfood 0.063000 3.400 1.000 

1203288000 12C Plum, prune, juice 0.063000 1.000 1.000 

1203288001 12C Plum, prune, juice-babyfood 0.063000 1.000 1.000 

1003307000 10C Pummelo 1.000000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 

1001369000 10A Tangerine 0.073000 1.000 1.000 

1001370000 10A Tangerine, juice 0.073000 0.200 1.000 

8601000000 86A Water, direct, all sources 0.016500 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.016500 1.000 1.000 

1500401000 15 Wheat, grain 0.017000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 0.017000 1.000 1.000 

1500402000 15 Wheat, flour 0.017000 0.150 1.000 

1500402001 15 Wheat, flour-babyfood 0.017000 0.150 1.000 

1500403000 15 Wheat, germ 0.017000 0.850 1.000 

1500404000 15 Wheat, bran 0.017000 1.400 1.000 
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

Page 17 of 21

Attachment 4: Results of Chronic Dietary Exposure Analysis

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for FENBUCONAZOLE NHANES 2003-2008 2-day

Residue file name: J:\Fenbuconazole\FENBUCONCHR.R08

 Adjustment factor #2 NOT used.

Analysis Date 11-28-2012/09:31:58 Residue file dated: 11-28-2012/09:31:20

Reference dose (RfD, Chronic) = .03 mg/kg bw/day

COMMENT 1: RfDs are PADs and acute value is for females 13-49 only

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.000705 2.3%

Hispanic 0.000678 2.3%

Non-Hisp-White 0.000729 2.4%

Non-Hisp-Black 0.000573 1.9%

Non-Hisp-Other 0.000758 2.5%

Nursing Infants 0.000875 2.9%

Non-Nursing Infants 0.002148 7.2%

Female 13+ PREG 0.000591 2.0%

Children 1-6 0.001595 5.3%

Children 7-12 0.000721 2.4%

Male 13-19 0.000429 1.4%

Female 13-19/NP 0.000489 1.6%

Male 20+ 0.000565 1.9%

Female 20+/NP 0.000660 2.2%

Seniors 55+ 0.000659 2.2%

All Infants 0.001755 5.8%

Female 13-50 0.000603 2.0%

Children 1-2 0.002018 6.7%

Children 3-5 0.001410 4.7%

Children 6-12 0.000796 2.7%

Youth 13-19 0.000458 1.5%

Adults 20-49 0.000587 2.0%

Adults 50-99 0.000652 2.2%

Female 13-49 0.000602 2.0%

-------------------------------------------------------------------------------
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

Page 18 of 21

Attachment 5: Residue Input File for Cancer Analysis

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for FENBUCONAZOLE

Residue file: J:\Fenbuconazole\FENBUCONCANCER.R08 Adjust. #2 NOT used

Analysis Date 11-29-2012 Residue file dated: 11-29-2012/09:02:27

Q* = 0.0036

Comment:RfDs are PADs and acute value is for females 13-49 only

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

Food Crop Residue Adj.Factors

EPA Code Grp Food Name (ppm) #1 #2 

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

1400003000 14 Almond 0.015000 1.000 0.050 

1400003001 14 Almond-babyfood 0.015000 1.000 0.050 

1400004000 14 Almond, oil 0.015000 1.000 0.050 

1400004001 14 Almond, oil-babyfood 0.015000 1.000 0.050 

1100007000 11 Apple, fruit with peel 0.142000 1.000 0.050 

1100008000 11 Apple, peeled fruit 0.142000 1.000 0.050 

1100008001 11 Apple, peeled fruit-babyfood 0.142000 1.000 0.050 

1100009000 11 Apple, dried 0.142000 8.000 0.050 

1100009001 11 Apple, dried-babyfood 0.142000 8.000 0.050 

1100010000 11 Apple, juice 0.142000 0.059 0.050 

1100010001 11 Apple, juice-babyfood 0.142000 0.059 0.050 

1100011000 11 Apple, sauce 0.142000 1.000 0.050 

1100011001 11 Apple, sauce-babyfood 0.142000 1.000 0.050 

1202012000 12B Apricot 0.307000 1.000 0.050 

1202012001 12B Apricot-babyfood 0.307000 1.000 0.050 

1202013000 12B Apricot, dried 0.307000 6.000 0.050 

1202014000 12B Apricot, juice 0.307000 1.000 0.050 

1202014001 12B Apricot, juice-babyfood 0.307000 1.000 0.050 

9500023000 O Banana 0.028000 1.000 1.000 

9500023001 O Banana-babyfood 0.028000 1.000 1.000 

9500024000 O Banana, dried 0.028000 3.900 1.000 

9500024001 O Banana, dried-babyfood 0.028000 3.900 1.000 

3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.050000 1.000 1.000 

0101052000 1A Beet, sugar 0.061000 1.000 0.010 

0101052001 1A Beet, sugar-babyfood 0.061000 1.000 0.010 

0101053000 1A Beet, sugar, molasses 0.061000 1.800 0.010 

0101053001 1A Beet, sugar, molasses-babyfood 0.061000 1.800 0.010 

1302057000 13B Blueberry 0.300000 1.000 0.550 

1302057001 13B Blueberry-babyfood 0.300000 1.000 0.550 

1201090000 12A Cherry 0.336000 1.000 0.150 

1201090001 12A Cherry-babyfood 0.336000 1.000 0.150 

1201091000 12A Cherry, juice 0.336000 1.000 0.150 

1201091001 12A Cherry, juice-babyfood 0.336000 1.000 0.150 

1001106000 10A Citron 0.073000 1.000 1.000 

1001107000 10A Citrus hybrids 0.073000 1.000 1.000 

1001108000 10A Citrus, oil 0.073000 47.000 1.000 

1307130000 13G Cranberry 0.199000 1.000 1.000 

1307130001 13G Cranberry-babyfood 0.199000 1.000 1.000 

1307131000 13G Cranberry, dried 0.199000 1.000 1.000 

1307132000 13G Cranberry, juice 0.199000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 0.199000 1.100 1.000 

1302136000 13B Currant 0.093000 1.000 1.000 

1302137000 13B Currant, dried 0.093000 1.000 1.000 

1302149000 13B Elderberry 0.093000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 

1302174000 13B Gooseberry 0.093000 1.000 1.000 

1304175000 13D Grape 0.390000 1.000 1.000 
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

Page 19 of 21

1304176000 13D Grape, juice 0.390000 0.180 1.000 

1304176001 13D Grape, juice-babyfood 0.390000 0.180 1.000 

9500177000 O Grape, leaves 0.390000 1.000 1.000 

9500178000 O Grape, raisin 0.390000 4.300 1.000 

1304179000 13D Grape, wine and sherry 0.390000 0.700 1.000 

1003180000 10C Grapefruit 0.016000 1.000 0.400 

1003181000 10C Grapefruit, juice 0.016000 0.200 0.400 

1302191000 13B Huckleberry 0.093000 1.000 1.000 

1002197000 10B Kumquat 0.073000 1.000 1.000 

1002199000 10B Lemon 0.073000 1.000 1.000 

1002200000 10B Lemon, juice 0.073000 0.200 1.000 

1002200001 10B Lemon, juice-babyfood 0.073000 0.200 1.000 

1002201000 10B Lemon, peel 0.652000 1.000 1.000 

1002206000 10B Lime 0.073000 1.000 1.000 

1002207000 10B Lime, juice 0.073000 0.200 1.000 

1002207001 10B Lime, juice-babyfood 0.073000 0.200 1.000 

1202230000 12B Nectarine 0.307000 1.000 0.050 

1001240000 10A Orange 0.017000 1.000 0.050 

1001241000 10A Orange, juice 0.017000 0.200 0.050 

1001241001 10A Orange, juice-babyfood 0.017000 0.200 0.050 

1001242000 10A Orange, peel 0.652000 1.000 0.050 

1202260000 12B Peach 0.307000 1.000 0.150 

1202260001 12B Peach-babyfood 0.307000 1.000 0.150 

1202261000 12B Peach, dried 0.307000 7.000 0.150 

1202261001 12B Peach, dried-babyfood 0.307000 7.000 0.150 

1202262000 12B Peach, juice 0.307000 1.000 0.150 

1202262001 12B Peach, juice-babyfood 0.307000 1.000 0.150 

9500263000 O Peanut 0.035000 1.000 1.000 

9500264000 O Peanut, butter 0.035000 1.890 1.000 

9500265000 O Peanut, oil 0.035000 1.000 1.000 

1400269000 14 Pecan 0.015000 1.000 0.100 

0802270000 8B Pepper, bell 0.190000 1.000 1.000 

0802270001 8B Pepper, bell-babyfood 0.190000 1.000 1.000 

0802271000 8B Pepper, bell, dried 0.190000 1.000 1.000 

0802271001 8B Pepper, bell, dried-babyfood 0.190000 1.000 1.000 

0802272000 8BC Pepper, nonbell 0.190000 1.000 1.000 

0802272001 8BC Pepper, nonbell-babyfood 0.190000 1.000 1.000 

0802273000 8BC Pepper, nonbell, dried 0.190000 1.000 1.000 

9500283000 O Plantain 0.028000 1.000 1.000 

9500284000 O Plantain, dried 0.028000 3.900 1.000 

1203285000 12C Plum 0.063000 1.000 0.010 

1203285001 12C Plum-babyfood 0.063000 1.000 0.010 

1203286000 12C Plum, prune, fresh 0.063000 1.000 0.010 

1203286001 12C Plum, prune, fresh-babyfood 0.063000 1.000 0.010 

1203287000 12C Plum, prune, dried 0.063000 3.400 0.010 

1203287001 12C Plum, prune, dried-babyfood 0.063000 3.400 0.010 

1203288000 12C Plum, prune, juice 0.063000 1.000 0.010 

1203288001 12C Plum, prune, juice-babyfood 0.063000 1.000 0.010 

1003307000 10C Pummelo 1.000000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 

1001369000 10A Tangerine 0.073000 1.000 0.010 

1001370000 10A Tangerine, juice 0.073000 0.200 0.010 

8601000000 86A Water, direct, all sources 0.011700 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.011700 1.000 1.000 

1500401000 15 Wheat, grain 0.017000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 0.017000 1.000 1.000 

1500402000 15 Wheat, flour 0.017000 0.150 1.000 

1500402001 15 Wheat, flour-babyfood 0.017000 0.150 1.000 

1500403000 15 Wheat, germ 0.017000 0.850 1.000 

1500404000 15 Wheat, bran 0.017000 1.400 1.000 
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

Page 20 of 21

Attachment 6: Results of Cancer Dietary Exposure Analysis

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for FENBUCONAZOLE NHANES 2003-2008 2-day

Residue file name: J:\Fenbuconazole\FENBUCONCANCER.R08

 Adjustment factor #2 NOT used.

Analysis Date 11-29-2012/09:02:48 Residue file dated: 11-29-2012/09:02:27

Q* = 0.0036 

COMMENT 1: RfDs are PADs and acute value is for females 13-49 only

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 Total exposure by population subgroup

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 Total Exposure

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

 Population mg/kg Lifetime risk

 Subgroup body wt/day (Q*= .0036)

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Total US Population 0.000604 2.18E-06
Fenbuconazole Dietary Exposure and Risk Assessment DP Number: 403621

Page 21 of 21

Attachment 7: Screening Level Usage Analysis (SLUA)

November 13, 2012

Screening Level Estimates of Agricultural Uses of Fenbuconazole 129011

Sorted Alphabetically

Crop Lbs. A.I. Percent Crop Treated

Average Maximum

1 Almonds 5,000 5 10

2 Apples 3,000 5 15

3 Apricots <500 5 5

4 Blueberries 5,000 55 60

5 Cherries 5,000 15 25

6 Grapefruit 8,000 40 55

7 Nectarines <500 5 5

8 Oranges 3,000 5 10

9 Peaches 4,000 15 25

10 Pecans 7,000 10 20

11 Plums/Prunes <500 <1 <2.5

12 Sugar Beets 1,000 <1 <2.5

13 Tangelos <500 10 15

14 Tangerines <500 <1 <2.5

All numbers rounded

<500 indicates less than 500 pounds of active ingredient

<2.5 indicates less than 2.5 percent of crop is treated

<1 indicates less than 1 percent of crop is treated

SLUA Data Sources Include:

USDA-NASS (United States Department of Agriculture’s National Agricultural Statistics Service)

Private Pesticide Market Research, 2001-2006

California DPR data