### F enbuconazole Diet ary Ex posur e and Risk Assessment DP Number: 40 362 1



### 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 Act ion Increasing

the Tolerance for Pep per s.

PC Code: 1290 II

Decision No.: 465307

Petition No.: 2F8034 DP Number : 403621 Registration No.: 62719-421 Regulatory Action: Section 3 Toleranc e
Amendment

Case No.: 701 2 Ri sk Assess m e n t Type: Die tary
TXR 

### No. : No n e
MRJD No

. : None CAS No.: 114369-43-6

40 CF R : 180.480



### FROM: Dennis McNeilly, Chemist 

# [3
....---- Registration Action Branch 2

Health Effects Division (7509P)

# THROUGH~915ouglas Dotson, Ph.D.,

# Chern**~** Kris t en R ury
, Biolog i st 

# · y_ 

# \CS. (_)

. . /)

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

### Regist rati on Action Branch 2

TO: Hea lth Effects Division (75 09P)

Erin Malone / Shaja Joyner

, RM 20 Fungicide Branch Registration Division (7505 P)

E xecutive Summary

Acute, chronic, and cancer agg re gat e d ietary [food and drinkin g water] expo sure and risk

assessme n ts were conducted using the Dietary Exposure E valuation Mode l software with the

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

Page 1 of21

### 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

reques t for an increased to l erance for fenbuconazole on peppers.

Acute Dietary Exposure Results and Charact eri zation

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 pot e ntial 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 popula t ion adjusted

dose (aPAD) at the 95th percen t ile of exposure. T h is risk estimate is considerably lower than

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

Chronic Dietary (Food and Drinking Water) E xposure Result s an d C haracterization

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

field tria l s. Because of the manner in which these data were submitted and reviewed

, multiple

averages were ca l culated for many of the crops. F or these crops, the highes t average was used in

the analysis. The non

- cancer dietary analysis assumes 1 00% crop trea t ed

. The most highly exposed popu l ation 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 t hose used in the chronic noncancer assessment. The cancer analysis is further refined in that it makes u s e 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 

# o

6

•



### 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

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

.

Page 2 of21

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

Page 3 of 21 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

200 8 to support th e original tolerance petition for use on peppers ( D 350321

, D . Do tson

, 6 / 1 2/200 8 ).

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 analys i s. The average fiel d 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 ( D 350321 , D. Dotso n, 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 r esidues of fenbuconazole and its

residues of concern in almond s , apple s , banana s
, blueberries , citrus, cranberr ies , grape s , peanut s
, pecan s
, peppers, stone fruit, sugar beet s , and wheat. Residue estimates for the chronic and cancer

assessments are based o n 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 resi dues 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 diet ary 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 assessment s , respectively ).

Acute Assessment

. The acute dietary (food + water) assessment is a screening

- level assessment.
It is b ased 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 (2 4

. 1 ppb), which is a high

- end estimate that is derived from the requested use pattern for peppers . The acute assessment includes DEEMTM V ersion 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 proces sing, 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

Page 4 of 21 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 da ta within each volume. The highest of these three averages is used in the chronic assessments. The chronic assessments use DEEMTM v ersion

7. 81 default processing factors for commodities that do not have e mpirical processing factors.

The non

- cancer assess ment 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 Facto rs 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 Chroni c 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 P roc. 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

Be ef, 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 Pro cessing 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. Fac tor

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

Page 5 of 21 Table 1. Summary of Residues and Facto rs 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 Chroni c 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)

H uckleberry 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. Facto r (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 0.3 07 1.0 15

Peanut 0.1 1 0.035 1 100
Peanut, butter 0.1 1.89 0.035 1.89 100 Default Proc essing Factor
Peanut, oil 0.1 1 0.035 1 100

Pecan 0.05 1 0.015 1 1 0 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/ Emp irical Proc

. Factor s Plum, prune, juice 1 1 0.063 1.0 1 No concentration in juice

Pummelo 1 1 1 1 100 Sheep, meat byproduc ts 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 Proc essing Factor Wheat, germ 0.1 1 0.017 0.85 100 Empirical Proc essing Factor
Wheat, bran 0.1 1 0.017 1.4 100 Empirical Proc essing 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

Page 6 of 21 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 : a lmonds: 5%, Apples: 5%, apricots: 5%, blueberries: 55%, cherr ies: 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 concentration s (EDWC s ) used in the dietary risk assessment s w ere provided by the Environmental Fate and Effects Division (EFED, D 3 44352

, J. Lin

, 1 / 16 /200 8 ).

The EDWC s w ere incorporated directly into th e s e dietary assessment s 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 tri azole 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. T he 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 analys is. 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 ar e 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, cons umption 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

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

-

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

Page 7 of 21 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 th e residue level in each food or food

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting 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

multi plied 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 dist ribution 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) ba sis. 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 specificall y identified and noted in the risk assessment.

V I

. Toxicological Information

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

summarized in Table 2.

Table 2 . Summary of Toxicological Dose s 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

UF A = 10x

UF H = 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 (Gener al 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

UF A = 10x

UF H = 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

Page 8 of 21 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 thy roid 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 quantif ication of human risk (Q 1 *). 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 dat a, quantification of risk was derived using combined hepatocellular adenomas/carcinomas in female mice. The upper bound estimate of unit risk, Q 1 * (mg/kg/day) - 1 is 3.59 x 10 - 3 in human equivalents. Point of Departure (POD) = A data point or an estimat ed 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 (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adju sted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.



### VI I

. Results/Discussion

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

100% of the PAD. The DEEM

- FCIDTM analys e s 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 95 th 

### ). Table 4 lists the results for the general U.S. Population, all infants (<1 year old), children 1

- 2, ch ildren 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 95 th 

### , 99 th 

### , and 99.9 th 

### percentiles of exposure are reported in Table 3 . As percent crop treated estimates were not used in the assessment, HED recommends that the 95 th 

### percentile of exposure be used for regulation. The population subgroup Females 13

- 49 utilizes 2.9 % of the aPAD at the 95 th 

### percentile of exposure.

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

Population Subgroup aPAD (mkd)* 95 th Percentile 99 th Percentile 99.9 th 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

Page 9 of 21 Results of Chronic Dietary Exposure Analysis

In the chronic dietary exposure analysis, t h e most highly exposed population subgroup is c hildren

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) - 1 

### to the exposure value of 0.000 604 mg/kg/day yield s 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 Wat er)

Population Subgroup* Acute Dietary (95 th 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 0.000 604 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 year s 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 0.00 8618 2.9 0.000602 2.0



### VII I

. Characterization of Inputs/Outputs

In the acute and chronic (non

- cancer) dietary exposure analyses, c onservative esti mates of food

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

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

could be made to the se analys e s, but they are not neces sary 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 u sed 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 lab el. 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 magnitu de 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 an alyses 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

Page 10 of 21 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

.

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

Page 11 of 21 IX. Conclusions

Based on conservative assumptions, the acu te 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, t he c a ncer 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

Atta chment 3: Residue Input File for Chronic (Non

- Cancer) Analys i s Attachment 4: Results of Chronic Dietary Exposure Analysis Attachment 5: Residue Input File for Cancer Analysis

A ttachment 6 : Results of Cancer Dietary Exposure Analysis

A ttachment 7 : S cre ening L evel U sage A nalysis (SLUA)

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

Page 12 of 21 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

- b abyfood 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

120 2014001 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 1.0 00 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

10011060 00 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 1.0000 00 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 Or ange, 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

95002 63000 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 1.0 00000 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

- babyfo od 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 1.0 00 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 : Res ults 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) Analys i s

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

14000040 00 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 Ap ple, 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 0.30700 0 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

010105 3001 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, ju ice

- 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 0.093 000 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 1.00 0 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 1.0 00 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

1304 179000 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, j uice 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 0.0 17000 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

95 00265000 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 8 B 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 : Res u lts 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%

No n

- 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 Analys i s

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

1202014 001 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 B anana, 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 0.3360 00 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 1.00 0 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

13021 36000 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, ju ice 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 0.07 3000 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 1.0 00 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

100 1241001 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 12 B 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

1 203287000 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 Tange rine 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 : Res ults 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

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

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

Total Exposure

----------------------------------- Population mg/kg Lifetime risk
Subgroup body wt/day (Q*= .0036)

-------------------------------------- ------------- -------------- Total US Population 0.000604 2.18E

- 06

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

Page 21 of 21 A ttachment 7 : Screening Level Usage Analysis ( SLUA )

November 13, 20 12 Screening Level Estimates of Agricultural Uses of F enbuconazole 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 5 5

7 Nectarines <500 5 5

8 Oranges 3 ,000 5 10

9 Peaches 4 ,000 15 25

10 Pecans 7 ,000 1 0 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 rou nded <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 Natio nal Agricultural Statistics Service ) 

### Private Pesticide Market Research, 2001

- 2006

California DPR data