Propiconazole

PC Cod e: 1 22 1 01 D ietary Exposure and Risk Assessment DP Number: D 4l4627



### UNITED STATES ENVIRONMENTAL PROTECTION
AGENCY WASHINGTON, D.C. 20460

Office of Chemical Safety and Pollution Prevention



### MEMORANDUM



### Date: Fe bruar y 27

, 201 4



### SU BJEC T : Propiconazole: Acute and Chronic Aggr e ga te Dietary (Food and

Drinkin g Water) Expo s ure and Risk Asse ssment s for Rape seed Cr op Subg roup 20A.

PC Co d e: 12210 I DP Barcode: 0414627

Decision No

. : 473635

Petition No.: 2F8135 Re gistration No

. : 10 0-617

Re gu la tory Act i on: Sect ion 3

Case No.: 3125. Risk Assessment Type: D ietary assess men t

TXR No.: N / A

# ioA~~}o~~/- MRJD No.: N / A



### FROM: Thurston 

## G

. Morton, C h e mi s t

# .//~ /' 

# J{j

Risk Assessme nt Bran c h IV (RAB IV)

H ealth Effec t s Di vis i on (HED) (7509P)



### THROUGH: Tom Bloem,**Chemist ~.**  

### . 

## c:-:r- ·

# ~ William C ut ch in, Ch;mist 

# 11. '

,. Dietary Exposure Scie n ce Adv i sory Co unci l ( D ESAC)

HED (7509P)

A nd

Sus an Hummel, Senio r Sc ienti s t 

# 8 /

, /)

Elissa Reaves, PhD, Branch Chief**~** 

## r**~** 

### RABIV

HED (7509P)



### TO: Erin Malone

F ungic i d e Branch Registration Di v ision (7505P)

This document provides the HED 's dietary e xposure risk assessment of the new u se of propiconazole on rapeseed c rop subgroup 20A.

Pagel of24Propiconazole

P C Code: 122101



### Executive Summary Die t ary Exposure and Risk Assessment DP Number: 0414 627



### Propiconazole acute and chron ic dietary exposure assessments were conducted using the Dietary Exposure Eva lua tion Model software with the Food Commodity Intake Database

DE EM -FCIDTM, Version 3.16, which incorporates consumption data from USDA's

Nat ional Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. The

ana l yses were performed to support the Section 3 registration on rapeseed crop subgroup

20A.

This memorandum was reviewed by two p ee r reviewers of t h e DESAC

, per DESAC SOP

2012.1.

Attached are acute and chronic dietary risk assessments for this new u se. Thi s dietary

assessment is for residues of propiconazole and its metabolite s convertible to 2,4-

dichlorobenzoic acid (2,4-DCBA)

, expressed as propiconazole equiva l ents. T h e common metabolites- triazole

, triazolylalanine (TA)

, triazo l ylacetic acid (T AA), and triazolylpyruvic acid are also residues of concern. Since these are common metabolites

from several triazole pes ti cides and have their own toxico l ogical endpoints, the risk

assessment fo r triazoles wi ll be as sess ed separately.

Acute Dietary (Food and Drinking Wa ter) Exposure Results an d Characterization

An acute dietary analysis for propiconazole was conducted using tolerance l eve ls and 100

%CT for all existing and proposed uses. The acute population adjusted dose (PAD) i s 0.3 mg!k g/ da y for all population subgroups (includes females 13-49 years). The results of

the analysis indicate that ac ute risk from the dietary exposure (food and water) to propiconazole from the existing and propo se d uses did not exce ed H E D's lev e l of

concern for the genera l U.S. populat i on or any population subgroup. At the 95 1 h 

### percentile, the exposure to the general U.S. population is 26% ofthe aPAD; the most highly exposure subgroup (chi l dren 1-2 yrs old) is 84% of the aPAD

.

Chro nic Dietary (Food and Drinking Water) Exposure Results and C haracteri zat ion

A chronic dietary analysis for propiconazol e was conducted using tolerance l evels for

some commodities

, average field trial residues for the remaining commodities

, and 100

%CT for a ll existing and proposed uses. The chronic population adju s ted do se (cPAD) is

0.1 mg!k g/ day. Re su lt s of the analysis indica te tha t chronic risk from the dietary

expos ur e (food and water) to p r opiconazole from the ex istin g and proposed uses did not
exceed H E D's lev e l of concern for the general U.S. population or any population

su bgroup. The exposure to the general U.S

. population is 7.4 % of the cPAD, and the

most hi g hl y exposed subgroup (children 1- 2 yrs old) i s 24% ofthe cPAD.

Pa ge 2 of24Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 3 of 24 

### C ancer Dietary ( Food and Drinking Water ) Exposure Resul ts and Characterization

The HED Carcinogenicity Peer Review Committee (CPRC) classified propiconazole as Group C

- possible human carcinogen and recommended that for the purpose of risk

characterization the R eference Dose (RfD) approach should be used and would be protective.

I. Introduction

Propiconazole is a triazole

- type fungicide that provides broad spectrum disease control through inhibition of sterol biosynthesis in fungi. It is registered to Syngenta Crop Protection for the control of fungal dise ases on a variety of crops. This dietary exposure

assessment is for a new use on oilseeds crop subgroup 20A

.

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed a s 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 PAD. The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generally concerned when estimated cancer risk

exceeds one in one m illion

. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21

- JUN

- 2000,

web link: http://www.epa.gov/fedrgstr/EPA

- PEST/2000/July/Day

- 12/6061.pdf ; or see SOP 99.6 ( 20

- AUG

- 1999 ).

The most recent dietary risk assessment for propiconazole was conducted by T. Morton ( DP 403 630

, 2 / 27 / 1 3 ).Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 4 of 24 

### II. Residue Information

Summary of Metabolites and Degradates to be included in the Risk Assessment and Tolerance Expression

.

Matrix For Risk Assessment  For Tolerance Expression

Plants Parent plus all metabolites convertible to 2,4

-

DCBA Parent only

Rotational crop Parent plus all metabolites convertible to 2,4

-

DCBA Parent only

Livestock: Parent plus all metabolites convertible to 2,4

-

DCBA Parent only

Water Parent only N/A

Note: For all triazole

- containing pesticides, the t riazole

- containing metabolites 1,2,4

- T, TA, and TAA should also be included as residues of concern for risk assessment purposes only for plant and livestock

commodities. Since these metabolites are common to the entire class of triazole

- derivative fungicid es and because of differential toxicity between the metabolites and the various parent compounds, risks associated with exposure to 1,2,4

- T and to TA/TAA are addressed in separate risk assessment documents.

M1 = 5

- [(4

- chlorophenyl)methyl]

- 2

- methoxyl

- 2

- met hyl

- 1

- (1 H

- 1,2,4

- triazol

- 1

- ylmethyl)

- 1

- cyclopentanol;

M11 = 5

- [(4

- chlorophenyl)methoxyl]

- 2,2

- dimethyl

- 1

- (1 H

- 1,2,4

- triazol

- 1

- ylmethyl)

- 1

- cyclopentanol; M12

= 5

- [(4

- chlorophenyl)methyl]

- 2

- carboxyl

- 2

- methyl

- 1

- (1 H

- 1,2,4

- triazol

- 1

- ylmethyl)

- 1

- cyclopentanol; M31 = (1S*,3R*,5S*)

- 3

- hydroxy

- cis

- metconazole; 1,2,4

- T = 1 H

- 1,2,4

- triazole; TAA = 1 H

- 1,2,4

- triazol

- 1

- yl acetic acid; TA = 2

- amino

- 3

- (1 H

- 1,2,4

- triazol

- 1

- yl)propanoic acid.



### Residue Da ta used for Acute and Chronic Assessments:

The acute assessment w as based on the assumption of tolerance

- level residues for all commodities with existing and proposed tolerances and 100% crop treated (%CT) for all

commodities. The chronic assessment was based on tolerance level residues for some commodities, average field trial r esidues for the remaining commodities, and 100% crop treated (%CT)

. The existing tolerances are listed in 40 CFR §180.434. The proposed

new tolerance level s used in the DEEM are presented in Table 1

. DEEM default processing factors from DEEM (Version 7.8 1) were used for all processed commodities

that d o not have individual tolerance s except for citrus juice s which were reduced to 1 since no concentration of propiconazole residues occurred.

The recommended tolerance for rapeseed crop subgroup 20A is 0.30 ppm.

Propiconazole existing tolerances:

§ 180.434 Propiconazole; tolerances for residues.



### (a) General . Tolerances are established for the combined residues of the fungicide 1

- [[2

- (2,4

- dichlorophenyl)

- 4

- propyl

- 1,3

- dioxolan

- 2

- yl] methyl]

- 1H

- 1,2,4

- triazo le and its metabolites determined as 2,4

- dichlorobenzoic acid and expressed as parent compound in or on the following commodities:Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 5 of 24 Commodity Parts per million

Banana 0.2

Barley, bran 6.0

Barley, grain 3.0

Bean, dry seed 0.40

Bean, snap 0.70

Bean, suc culent shelled 0.10

Beet, garden, roots 0.30

Beet, garden, tops 5.5

Beet, sugar, molasses 1.5

Beet, sugar, roots 0.3

Beet, sugar, tops 10

Bushberry, subgroup 13

- 07B 1.0

Caneberry, subgroup 13

- 07A 1.0

Carrot, roots 0.25

Cattle, fat 0.05

Cattle, ki dney 2.0

Cattle, liver 2.0

Cattle, meat 0.05

Cattle, meat byproducts, except liver and kidney 0.05

Cilantro, leaves 13

Citrus, oil 1000

Corn, field, grain 0.2

Corn, pop, grain 0.2

Corn, sweet, kernel plus cob with husks removed 0.1

Fruit, citrus, group 10

- 10 8.0

Fruit, stone, group 12, except plum 4.0

Goat, fat 0.05

Goat, kidney 2.0

Goat, liver 2.0

Goat, meat 0.05

Goat, meat byproducts, except liver and kidney 0.05

Hog, kidney 0.2

Hog, liver 0.2

Horse, fat 0.05

Horse, kidney 2.0

Horse, l iver 2.0

Horse, meat 0.05

Horse, meat byproducts, except liver and kidney 0.05

Leaf petioles subgroup 4B 5.0

Low growing berry subgroup 13

- 07G, except cranberry 1.3Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 6 of 24 Milk 0.05

Mushroom 0.1

Nut, tree, group 14 0.1

Oat, grain 3.0

Onion, bulb subgroup 3

- 07A 0.2

Onion, green, subgroup 3

- 07B 9.0

Parsley, fresh leaves 13

Parsley, dried leaves 35

Peanut 0.2

Peppermint, tops 10.0

Pineapple 4.5

Pistachio 0.1

Plum 0.60

Rice, bran 15

Rice, grain 7.0

Rye, bran 0.6

Rye, grain 0.3

Sheep, fat 0.05

Sh eep, kidney 2.0

Sheep, liver 2.0

Sheep, meat 0.05

Sheep, meat byproducts, except liver and kidney 0.05

Sorghum, grain, grain 3.5

Soybean, seed 2.0

Spearmint, tops 10.0

Sugarcane, cane 0.4

Tomato 3.0

Vegetable, foliage of legume, group 7 30

Wheat, bran 0.6

Wheat, grain 0.3



### (b) Section 18 emergency exemptions . Time

- limited tolerances are established for residues of propiconazole (1

- [[2

- (2,4

- dichlorophenyl)

- 4

- propyl

- 1,3

- dioxolan

- 2

- yl] methyl]

- 1H

- 1,2,4

- triazole) and its metabolites determined as 2, 4

- dichlorobenzoic acid and expressed as parent compound, in connection with use of the pesticide under section 18 emergency exemptions granted by EPA. The tolerances will expire and are revoked on the dates specified in the following table:

Commodity Parts per million Expiration/revocation date

Avocado 10 12/31/13

Nectarine 2.0 12/31/13

Peach 2.0 12/31/13Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 7 of 24 

### (c) Tolerances with regional registrations . A tolerance with regional registration, as defined in § 180.1(l), is established for residues of 1

- [[2

- (2 ,4

- dichlorophenyl)

- 4

- propyl

1,3

- dioxolan

- 2

- yl]methyl]

- 1H

- 1,2,4

- triazole and its metabolites determined as 2,4

- dichlorobenzoic acid and expressed as parent compound, in or on the following

commodities:

Commodity Parts per million

Cranberry 1.0

Rice, wild, grain 0.5



### Average Field Trial Residues used in the chronic dietary exposure assessment :

Beets, garden and sugar..............0.12 ppm Carrot..................................0.10 ppm Onion, green and leek................2.43 ppm Parsley, fresh l eaves..................3.65 ppm Crop Group 4B........................1.01 ppm Soybean seed...........................0.26 ppm Tomato.................................0.791 ppm Grapefruit..............................1.18 ppm Lemon..................................1.79 ppm Lime....................................2.34 ppm Orange.................................2.34 ppm Cherry..................................0.563 ppm

A pricot, nectarine, peach............0.961 ppm Plum....................................0.183 ppm Blueberry

..................... ..........0.35 ppm Cranberries..............................0.32 ppm Other small berries.....................0.36 ppm Strawberry...............................0.35 ppm Almond..................................0.038 ppm Corn, field and pop.....................0.036 p pm Rice.......................................1.49 ppm Sorghum..................................1.27 ppm

Wheat.....................................0. 0 43 ppm Pineapple.................................1.03 ppm Sugarcane.................................0. 1 2 ppm Oilseeds....................................0.081 ppm Table 1 . Tolerance Summary for Propiconazole for Petition 2F8135

Crop Commodity Established

Tolerance (ppm) HED

Recommended Tolerance (ppm) Comments ( Correct Commodity Definition)

Tolerances under §180.434(a) to be Added Rapeseed subgrou p 20A none 0. 3 0 Data are adequate to support the use.Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 8 of 24 

### III. Drinking Water Data

The drinking water residues used in the dietary ris k assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memorandum:

“ Drinking Water Assessment for the petition (1F7892) that proposes tolerances for residues of p ropiconazole on sugarcane ” ( I. Abdel

- Saheb , 0 3 / 19 / 1 3 , D 408485 ) and incorporated directly into this dietary assessment. Water residues were incorporated in

the DEEM

- FCID into the food categories “water, direct, all sources” and “water, indirect,

all sources.”

In the case of propiconazole, turf, a previ ously registered crop, has the highest application rate (6.285 lb a.i./A, 8 applications of 0.786 lb a.i../A per year with a 14

- day interval between applications) ((DP 325821,328690, Dated 07/07/2006). The proposed new use does not result in higher EDWCs than those estimated for turf uses.

The estimated surface water drinking water concentrations for propiconazole are:

55.78 ug /L for the 1 in 10 year annual peak concentration (acute)

21.61 ug /L for the 1 in 10 year annual mean concentration (non

- cancer chronic) and

The SCI

- GROW estimated ground water drinking water concentrations for propiconazole are not expected to exceed 0.64 μg/L

The highest estimates from surface water (acute, 55.78 ppb and chronic, 21.61 ppb ) are directly entered into th e exposure model to assess the contributions from drinking water.

The model and its description are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.

IV. DEEM

- FCI DTM Program and Consumption Information

Propiconazole acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database

DEEM

- FCIDTM, Version 3.16, which incorporates co nsumption data from USDA’s National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. 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 trans lation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption

eve nts. 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.Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 9 of 24 

### population, all infants (<1 year old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, adults 20

- 49, females 13

- 49, and adults 50

- 99 years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or

food

- form (e.g., orange o r 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 resid ue 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 populatio n subgroup.

For acute exposure assessments, individual one

- day food consumption data are used on

an individual

- by

- individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a to tal 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 a PAD 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 an d risk are reported for all tiers of analysis. However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V. Toxicological Information

HED’s Hazard Ident ification Assessment Review Committee (HIARC) concluded that the toxicology database for propiconazole is complete for FQPA assessment. Endpoints and dose response have been selected for acute and chronic dietary exposures.

The HED Carcinogenicity Peer R eview Committee (CPRC) classified propiconazole as Group C

- possible human carcinogen and recommended that for the purpose of risk characterization the reference Dose (RfD) approach should be used and would be protective.Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 10 of 24 Table 2 Summary of T oxicol ogical Doses and Endpoints for Propiconazole for Use in Dietary Exposure Risk Assessments Exposure/

Scenario Point of

Departure Uncertainty/FQPA

Safety Factors RfD, PAD, Level

of Concern Study and Toxicological

Effects

Acute Dietary (General Popula tion, including

Infants and Children) NOAEL=

30 mg/kg/day UF A = 10 x

UF H = 10 x FQPA SF= 1 x Acute RfD = 0.3

mg/kg/day

aPAD =0.3 mg/kg/day Acute neurotoxicity study

LOAEL = 100 mg/kg/day based on clinical signs of toxicity (piloerection in one male,

diarrhea in one female, tip toe gait in 3 females).

Acute Dietary (Females 13

- 49 years of age) NOAEL =

30 mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Acute RfD = 0.3

mg/kg/day

aPAD =0.3 mg/kg/day Developmental Toxicity Study

-

Rats. LOAEL = 90 mg/kg/day based

on i ncreased incidence of rudimentary ribs, un

- ossified sternebrae, as well as increased

incidence of shortened and absent renal papillae and increased cleft palate.

Chronic Dietary (All Populations) NOAEL=

10 mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Chroni c RfD = 0.1

mg/kg/day

cPAD =

0.1 mg/kg/day 24

- month oncogenicity study

on CD

- 1 mice.

LOAEL = 50 mg/kg/day based

on non

- neoplastic liver effects (increased liver weight in males

and increase in liver lesions:

masses/raised areas/ swellings/nodular areas

mai nly). Cancer (oral, dermal, inhalation) Classification: Group C, possible human carcinogen, RfD approach for risk

characterization. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and use d 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 = extrapolat ion from animal to human (intraspecies). UF H = potential variation in sensitivity among members of the human population (interspecies). UF DB = to account for the absence of key dat a (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. N/A = not applicable.Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 11 of 24 

### VI. 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 reported in Table s 3 and 4 are for the general U.S. Population, all infants (<1 year old), children 1

- 2,

children 3

- 4 , children 6

- 12, youth 13

- 19, females 13

- 49, adults 20

- 49, and adults 50

- 99

years.

At the 95 th 

### percentile, the acute dietary exposure (food and water) to general US population is 26 % of the aPAD, and the most highly exposed subgroup, Children 1

- 2 yrs old, is 8 4 % of the aPAD . The chronic dietary exposure to general US population is 7. 4 % of the cPAD, and the most highly exposed subgroup , Children 1

- 2 yrs old, is 24 % of the cPAD. All the dietary risk estimates are below 100% of the PADs.

These an alyses are highly conservat ive dietary exposure assessments. Further refinement to the analyses could be made through the use of anticipated residues, incorporation of percentages of crops treated with propiconazole, and/or monitoring data that better reflect

residues at the time o f consumption. Since risk estimates are well below HED’s level of concern, a more highly refined analysis is not needed at this time.

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

Table 3 . Results of Acute Dietary Exposure Analys is for Food and Drinking Water

Population Subgroup aPAD (mg/kg/day) 95th Percentile Exposure (mg/kg/day) % aPAD General U.S. Population

0.3 0.0 7 7 544 2 6 All Infants (< 1 year old) 0. 108 047 3 6

Children 1

- 2 years old 0. 2 5 4 417 8 4

Children 3

- 5 years old 0. 1 94 196 6 5

Children 6

- 12 years old 0. 106 032 3 5

Youth 13

- 19 years old 0. 0 7 3705 2 5

Adults 20

- 49 years old 0. 0 61 213 20

Adults 50

- 99 years old 0. 0 50 880 1 7

Females 13

- 49 years old 0. 0 60 562 20Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 12 of 24 

### Results of Chronic Dietary (Food and D rinking Water) Exposure Analysis

Table 4 . Results of Chronic Dietary Exposure Analysis for Food and Drinking Water

Population Subgroup cPAD (mg/kg/day) Exposure (mg/kg/day) % cPAD General U.S. Population

0.1 0. 0 0 7 434 7. 4 All Infants (< 1 year old) 0. 0 10 284 1 0

Children 1

- 2 years old 0.02 3 722 2 4

Children 3

- 5 years old 0. 01 9 125 1 9

Children 6

- 12 years old 0. 0 09943 9.9

Youth 13

- 19 years old 0. 00 60 24 6. 0

Adults 20

- 49 years old 0.0 0 6 192 6.2

Adults 50

- 99 years old 0.0 0 56 20 5. 6

Females 13

- 49 ye ars old 0.0 0 5 6 25 5. 6



### VII. Characterization of Inputs/Outputs

The acute analysis assumed tolerance

- level residues, 100% CT, and empirical or

DEEM  default processing factors. The chronic analysis assumed average field trial

residues for some commodit ies, tolerance

- level residues for the remaining commodities

, 100% CT, and empirical or DEEM  default processing factors. Therefore, these analyses are considered conservative. Since risk estimates are well below HED’s level of

concern t hey do not warrant the need for further refinement at this time.

VI II

. Conclusions

These dietary analyses demonstrate that the requested amended use for propiconazole will not result in dietary risk estimates that exceed HED’s level of concern for any of the regulated pop ulation subgroups, including those comprised of infants and children. A summary of the dietary exposure analyses is given in Table 5

.Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 13 of 24 Table 5 . Summary of Dietary Exposure and Risk for Propiconazole FOOD PLUS DRINKING WATER.

Population S ubgroup 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 0.0 77544 26 0. 007434 7.4

N/A All Infants (< 1 year old) 0

. 108047 36 0. 010284 10

Children 1

- 2 years old 0.2 54417 84 0.02 3722 2 4

Children 3

- 5 years old 0. 194196 65 0. 019125 19

Children 6

- 12 years old 0. 106032 35 0. 009943 9.9

Youth 13

- 19 years old 0. 073705 25 0. 006024 6.0

Adults 20

- 49 years old 0. 061213 2 0 0.0 06192 6.2

Adults 50

- 99 years old 0. 050880 17 0.0 05620 5.6

Females 13

- 49 years old 0. 060562 20 0.0 05625 5.6



### IX

. List of Attachments

Attachment 1. Acute Food plus Water Residue Input file.

Attachment 2. Acute Results file.

Attachment 3. Chroni c Food plus Water Residue Input file.

Attachment 4. Chronic Results file.Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 14 of 24 

### Attachment 1. Acute Food plus Water Residue Input file.

Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 122101 Propiconazole \ Petition 2F8135 Oil S eeds 20A \ 122101 Acute 2F8135 Aug 2013.R08 Chemical: Propiconazole RfD(Chronic): .1 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .3 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day
Date created/last modified: 09

- 04

- 2013/14:27:11 Program ver. 3.16 , 03

- 08

- d

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

--- ------- ---- ------------------------------- ---------- ------ ------ ------- 0101050000 1AB Beet, garden, roots 0.300000 1.000 1.000 0101050001 1AB Beet, garden, roots

- babyfood 0.300000 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 1.500000 1.000 1.000 0101053001 1A Beet, sugar, molasses

- babyfood 1.500000 1.000 1.000

0101078000 1AB Carrot 0.250000 1.000 1.000

0101078001 1AB Carrot

- babyfood 0.250000 1.000 1.000 0101079000 1AB Carrot, juice 0.250000 1.000 1. 000 0200051000 2 Beet, garden, tops 5.500000 1.000 1.000 0301165000 3A Garlic, bulb 0.200000 1.000 1.000 0301165001 3A Garlic, bulb

- babyfood 0.200000 1.000 1.000

0301237000 3A Oni on, bulb 0.200000 1.000 1.000 0301237001 3A Onion, bulb

- babyfood 0.200000 1.000 1.000 0301238000 3A Onion, bulb, dried 0.200000 9.000 1.000 0301238001 3A Onion, bulb, dried

- babyfood 0.200000 9.000 1.000
0301338000 3A Shallot, bulb 0.200000 1.000 1.000 0302103000 3B Chive, fresh leaves 9.000000 1.000 1.000

0302198000 3B Leek 9.000000 1.000 1.000 0302239000 3B Onion, green 9.000000 1.000 1.000
0302338500 3B Shallot, fresh leaves 9.000000 1.000 1.000 0401248000 4A Parsley, leaves 13.000000 1.000 1.000

0402076000 4B C ardoon 5.000000 1.000 1.000 0402085000 4B Celery 5.000000 1.000 1.000 0402085001 4B Celery

- babyfood 5.000000 1.000 1.000 0402086000 4B Celery, juice 5.000000 1.000 1.000

0402087000 4B Celtuce 5.000000 1.000 1.000
0402152000 4B Fennel, Florence 5.000000 1.000 1.000

0402322000 4B Rhubarb 5.000000 1.000 1.000

0402367000 4B Swiss chard 5.000000 1.000 1.000 0600347000 6 Soybean, seed 2.000000 1.000 1.000 0600349000 6 Soybean, soy milk 2.000000 1.000 1.000

0600349001 6 Soybean, soy milk

- babyfood or in 2.000000 1.000 1.000 0600350000 6 Soybean, oil 2.000000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 2.000000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.700000 1.000 1.000 0601043001 6A Bean, snap, succulent

- babyfood 0.700000 1.000 1.000 0601349500 6AB Soybean, vegetable 2.000000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.100000 1.0 00 1.000 0602033000 6B Bean, cowpea, succulent 0.100000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.100000 1.000 1.000
0603030000 6C Bean, black, seed 0.400000 1.000 1.000

0603032000 6C Bean, broad, seed 0.400000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.400000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.400000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.400000 1.000 1.000 0603038000 6C Bean, lima, seed 0.400000 1.000 1.000 0603039000 6C Bean, mung, seed 0.400000 1.000 1.000 0603040000 6C Bean, navy, seed 0.400000 1 .000 1.000 0603041000 6C Bean, pink, seed 0.400000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.400000 1.000 1.000 0603098000 6C Chickpea, seed 0.400000 1.000 1.000

0603098001 6C Chickpea, seed

- babyfood 0.400000 1.000 1.000 0603099000 6C Chickpea, flour 0.400000 1.000 1.000
0603182000 6C Guar, seed 0.400000 1.000 1.000 0603182001 6C Guar, seed

- babyfood 0.400000 1.000 1.000 0603203000 6C Lentil, seed 0.400000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 15 of 24 0603348000 6C Soybean, flour 2.000000 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 2.000000 1.000 1.000

0801374000 8A Tomatillo 3.000000 1.000 1.000

0801375000 8A Tomato 3.000000 1.000 1.000

0801375001 8A Tomato

- babyfood 3.000000 1.000 1.000

080137600 0 8A Tomato, paste 3.000000 5.400 1.000 0801376001 8A Tomato, paste

- babyfood 3.000000 5.400 1.000 0801377000 8A Tomato, puree 3.000000 3.300 1.000 0801377001 8A Tomato, puree

- baby food 3.000000 3.300 1.000 0801378000 8A Tomato, dried 3.000000 14.300 1.000
0801378001 8A Tomato, dried

- babyfood 3.000000 14.300 1.000 0801379000 8A Tomato, juice 3.000000 1.500 1.000

1001106000 10A Citron 8.000000 1.000 1.000 1001107000 10A Citrus hybrids 8.000000 1.000 1.000
1001108000 10A Citrus, oil 1000. 1.000 1.000

1001240 000 10A Orange 8.000000 1.000 1.000 1001241000 10A Orange, juice 8.000000 1.000 1.000 1001241001 10A Orange, juice

- babyfood 8.000000 1.000 1.000 1001242000 10A Orange, peel 8.000000 1.000 1.000 1001369000 10A Tangerine 8.000000 1.000 1.000 1001370000 10A Tangerine, juice 8.000000 1.000 1.000 1002197000 10B Kumquat 8.0000 00 1.000 1.000

1002199000 10B Lemon 8.000000 1.000 1.000 1002200000 10B Lemon, juice 8.000000 1.000 1.000 1002200001 10B Lemon, juice

- babyfood 8.000000 1.000 1.000

10022 01000 10B Lemon, peel 8.000000 1.000 1.000

1002206000 10B Lime 8.000000 1.000 1.000 1002207000 10B Lime, juice 8.000000 1.000 1.000 1002207001 10B Lime, juice

- ba byfood 8.000000 1.000 1.000 1003180000 10C Grapefruit 8.000000 1.000 1.000 1003181000 10C Grapefruit, juice 8.000000 1.000 1.000

1003307000 10C Pummelo 8.00 0000 1.000 1.000 1201090000 12A Cherry 4.000000 1.000 1.000 1201090001 12A Cherry

- babyfood 4.000000 1.000 1.000 1201091000 12A Cherry, juice 4.000000 1.500 1.000

120 1091001 12A Cherry, juice

- babyfood 4.000000 1.500 1.000 1202012000 12B Apricot 4.000000 1.000 1.000 1202012001 12B Apricot

- babyfood 4.000000 1.000 1.000 1202013000 12B Apricot, dri ed 4.000000 6.000 1.000 1202014000 12B Apricot, juice 4.000000 1.000 1.000 1202014001 12B Apricot, juice

- babyfood 4.000000 1.000 1.000

1202230000 12B Nectarine 4. 000000 1.000 1.000

1202260000 12B Peach 4.000000 1.000 1.000

1202260001 12B Peach

- babyfood 4.000000 1.000 1.000 1202261000 12B Peach, dried 4.000000 7.000 1.000

1 202261001 12B Peach, dried

- babyfood 4.000000 7.000 1.000 1202262000 12B Peach, juice 4.000000 1.000 1.000 1202262001 12B Peach, juice

- babyfood 4.000000 1.000 1.000

1203285000 12C Plum 0.600000 1.000 1.000

1203285001 12C Plum

- babyfood 0.600000 1.000 1.000 1203286000 12C Plum, prune, fresh 0.600000 1.000 1.000 1203286001 12C Plum, prune, fresh

- babyfood 0.600000 1.000 1.000 1203287000 12C Plum, prune, dried 0.600000 5.000 1.000 1203287001 12C Plum, prune, dried

- babyfood 0.600000 5.000 1.000 1203288000 12C Plum, prune, juice 0.600000 1.400 1.000 1203288001 12C Plum, prune, juice

- babyfood 0.600000 1.400 1.000 1301055000 13A Blackberry 1.000000 1.000 1.000 1301056000 13A Blackberry, juice 1.000000 1.000 1.000

1301056001 13A Blackber ry, juice

- babyfood 1.000000 1.000 1.000 1301058000 13A Boysenberry 1.000000 1.000 1.000 1301208000 13A Loganberry 1.000000 1.000 1.000 1301320000 13A Raspberry 1.000000 1.000 1.000 1301320001 13A Raspberry

- babyfood 1.000000 1.000 1.000 1301321000 13A Raspberry, juice 1.000000 1.000 1.000 1301321001 13A Raspberry, juice

- babyfood 1.000000 1.000 1.000 1302057000 13B Blueberry 1.000000 1.000 1.000 1302057001 13B Blueberry

- babyfood 1.000000 1.000 1.000

1302136000 13B Currant 1.000000 1.000 1.000

1302137000 13B Curran t, dried 1.000000 1.000 1.000 1302149000 13B Elderberry 1.000000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 16 of 24 1302174000 13B Gooseberry 1.000000 1.000 1.000 1302191000 13B Huckleberry 1.000000 1.000 1.000 1307130000 13G Cranberry 1.000000 1.000 1.000 1307130001 13G Cranberry

- babyfood 1.000000 1.000 1.000 1307131000 13G Cranberry, dried 1.000000 1.000 1.0 00 1307132000 13G Cranberry, juice 1.000000 1.000 1.000 1307132001 13G Cranberry, juice

- babyfood 1.000000 1.000 1.000 1307359000 13G Strawberry 1.300000 1.000 1.000

1307359001 13G Stra wberry

- babyfood 1.300000 1.000 1.000 1307360000 13G Strawberry, juice 1.300000 1.000 1.000 1307360001 13G Strawberry, juice

- babyfood 1.300000 1.000 1.000

1400003000 14 Almond 0.100000 1.000 1.000

1400003001 14 Almond

- babyfood 0.100000 1.000 1.000 1400004000 14 Almond, oil 0.100000 1.000 1.000
1400004001 14 Almond, oil

- babyfood 0.100000 1.000 1 .000

1400059000 14 Brazil nut 0.100000 1.000 1.000

1400068000 14 Butternut 0.100000 1.000 1.000

1400081000 14 Cashew 0.100000 1.000 1.000

1400092000 14 Ch estnut 0.100000 1.000 1.000

1400155000 14 Hazelnut 0.100000 1.000 1.000 1400156000 14 Hazelnut, oil 0.100000 1.000 1.000 1400185000 14 Hickory nut 0.100000 1.000 1.000

1400213000 14 Macadamia nut 0.100000 1.000 1.000

1400269000 14 Pecan 0.100000 1.000 1.000

1400282000 14 Pistachio 0.100000 1.000 1.000

1400391000 14 Walnut 0.100000 1.000 1.000 1500025000 15 Barley, pearled barley 3.000000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 3.000000 1.000 1.000

1500026000 15 Barley, flour 3.000000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 3.000000 1.000 1.000 1500027000 15 Barley, bran 6.000000 1.000 1.000 1500120000 15 Corn, field, flour 0.200000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.200000 1.000 1.000 1500121000 15 Corn, field, meal 0.200000 1.000 1.000
1500121001 15 Corn, field, meal

- babyfood 0.200000 1.00 0 1.000 1500122000 15 Corn, field, bran 0.200000 1.000 1.000 1500123000 15 Corn, field, starch 0.200000 1.000 1.000
1500123001 15 Corn, field, starch

- babyfood 0.200000 1.000 1.000

1500124000 15 Corn, field, syrup 0.200000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.200000 1.500 1.000 1500125000 15 Corn, field, oil 0.200000 1.000 1.000
1500125001 15 Corn, field, oil

- babyfo od 0.200000 1.000 1.000 1500126000 15 Corn, pop 0.200000 1.000 1.000
1500127000 15 Corn, sweet 0.100000 1.000 1.000 1500127001 15 Corn, sweet

- babyfood 0.100000 1. 000 1.000
1500231000 15 Oat, bran 6.000000 1.000 1.000 1500232000 15 Oat, flour 3.000000 1.000 1.000
1500232001 15 Oat, flour

- babyfood 3.000000 1.000 1.000

1500233000 1 5 Oat, groats/rolled oats 3.000000 1.000 1.000 1500233001 15 Oat, groats/rolled oats

- babyfood 3.000000 1.000 1.000 1500323000 15 Rice, white 7.000000 1.000 1.000
1500323001 15 Rice, white

- babyfood 7.000000 1.000 1.000 1500324000 15 Rice, brown 7.000000 1.000 1.000
1500324001 15 Rice, brown

- babyfood 7.000000 1.000 1.000 1500325000 15 Rice, flour 7.000000 1.000 1.000 1500325001 15 Rice, flour

- babyfood 7.000000 1.000 1.000 1500326000 15 Rice, bran 15.000000 1.000 1.000
1500326001 15 Rice, bran

- babyfood 15.000000 1.000 1.000

1500328000 15 Rye, grain 0.300000 1.000 1.000 1500329000 15 Rye, flour 0.300000 1.000 1.000 1500344000 15 Sorghum, grain 3.500000 1.000 1.000 1500345000 15 Sorghum, syrup 3.500000 1.000 1.000 1500381000 15 Triticale, flour 0.300000 1.000 1.000 1500381001 15 Triticale, flour

- babyfood 0.300000 1.000 1.000 1500401000 15 Wheat, grain 0.300000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.300000 1.000 1.000
1500402000 15 Wheat, flour 0.300000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.300000 1.000 1.000

15004030 00 15 Wheat, germ 0.300000 1.000 1.000 1500404000 15 Wheat, bran 0.600000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 17 of 24 1500405000 15 Wild rice 0.500000 1.000 1.000
1901118000 19A Cilantro, leaves 13.000000 1.000 1.000 1901118001 19A Cilantro, leaves

- babyfood 13.000000 1.000 1.000 1901249000 19A Parsley, dried leaves 35.000000 1.000 1.000 1901249001 19A Parsley, dried leaves

- babyfood 35.00000 0 1.000 1.000 2001163000 20A Flax seed, oil 0.300000 0.200 1.000 2001319000 20A Rapeseed, oil 0.300000 0.200 1.000 2001319001 20A Rapeseed, oil

- babyfood 0.300000 0.200 1.000

200133 6000 20A Sesame, seed 0.300000 1.000 1.000
2001336001 20A Sesame, seed

- babyfood 0.300000 1.000 1.000 2001337000 20A Sesame, oil 0.300000 0.200 1.000 2001337001 20A Sesame, oil

- bab yfood 0.300000 0.200 1.000

2100228000 21 Mushroom 0.100000 1.000 1.000 3100044000 31 Beef, meat 0.050000 1.000 1.000
3100044001 31 Beef, meat

- babyfood 0.050 000 1.000 1.000 3100045000 31 Beef, meat, dried 0.050000 1.920 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

3100 047000 31 Beef, fat 0.050000 1.000 1.000
3100047001 31 Beef, fat

- babyfood 0.050000 1.000 1.000 3100048000 31 Beef, kidney 2.000000 1.000 1.000 3100049000 31 Beef, liver 2.000000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 2.000000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.0 50000 1.000 1.000 3200171000 32 Goat, fat 0.050000 1.000 1.000 3200172000 32 Goat, kidney 2.000000 1.000 1.000 3200173000 32 Goat, liver 2.000000 1.000 1.000

33 00189000 33 Horse, meat 0.050000 1.000 1.000 3400294000 34 Pork, kidney 0.200000 1.000 1.000
3400295000 34 Pork, liver 0.200000 1.000 1.000 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 3500341000 35 Sheep, fat 0 .050000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.050000 1.000 1.000 3500342000 35 Sheep, kidney 2.000000 1.000 1.000 3500343000 35 Sheep, liver 2.000000 1.000 1.000 3600222000 36 Milk, fat 0.050000 1.000 1.000
3600222001 36 Milk, fat

- baby food/infant formu 0.050000 1.000 1.000
3600223000 36 Milk, nonfat solids 0.050000 1.000 1.000
3600223001 36 Milk, non fat solids

- baby food/in 0.050000 1.000 1.000
3600224000 36 Milk, water 0.050000 1.000 1.000
3600224001 36 Milk, water

- babyfood/infant form 0.050000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.050000 1.000 1.000 8601000000 86A Water, direct, all sources 0.055780 1.000 1.000 8602000000 86B Water, indirect, all sources 0.055780 1.000 1.000

9500020000 O Avocado 10.000000 1.000 1.000

9500023000 O Banana 0.200000 1.000 1.000

9500023001 O Banana

- babyfood 0.200000 1.000 1.000 9500024000 O Banana, dried 0.200000 3.900 1.000
9500024001 O Banana, dried

- babyfood 0.200000 3.900 1.000

9500263000 O Peanut 0.200000 1.000 1.000
9500264000 O Peanut, butter 0.200000 1.890 1.000 9500265000 O Peanut, oil 0.200000 1.000 1.000 9500275000 O Peppermint 10.000000 1.000 1.000 9500276000 O Peppermint, oil 10.000000 1.000 1.000 9500279000 O Pineapple 4.500000 1.000 1.00 0 9500279001 O Pineapple

- babyfood 4.500000 1.000 1.000 9500280000 O Pineapple, dried 4.500000 5.000 1.000 9500281000 O Pineapple, juice 4.500000 1.700 1.000

9500281001 O Pinea pple, juice

- babyfood 4.500000 1.700 1.000

9500283000 O Plantain 0.200000 1.000 1.000 9500284000 O Plantain, dried 0.200000 3.900 1.000 9500352000 O Spearmint 10.000000 1.000 1.000 9500353000 O Spearmint, oil 10.000000 1.000 1.000 9500362000 O Sugarcane, sugar 0.400000 1.000 1.000 9500362001 O Sugarcane, sugar

- babyfood 0.400000 1.000 1. 000 9500363000 O Sugarcane, molasses 0.400000 1.000 1.000 9500363001 O Sugarcane, molasses

- babyfood 0.400000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 18 of 24 

### Attachment 2. Acute Results file.

U.S. EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for PROPICONAZOLE NHANES 2003

- 2008 2

- Day Residue file: 122101 Acute 2F8135 Aug 2013.R08 Adjustment factor #2 used. Analysis Date: 09

- 19

- 2013/09:29:56 Residue file dated: 09

- 19

- 2013/09:20:2 9 RAC/FF intake summed over 24 hours

Run Comment: ""

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population:

0.077544 25.85 0.159554 53.18 0.377263 125.75

All Infants:

0.108047 36.02 0.187692 62.56 0.351381 117.13

Children 1

- 2:

0.253417 84.47 0.432398 144.13 0.762600 254.20

Children 3

- 5:

0.194196 64.73 0.353441 117. 81 0.508080 169.36

Children 6

- 12:

0.106032 35.34 0.192330 64.11 0.418327 139.44

Youth 13

- 19:

0.073705 24.57 0.126458 42.15 0.195901 65.30

Adults 20

- 49:

0.06121 3 20.40 0.100171 33.39 0.185973 61.99

Adults 50

- 99:

0.050880 16.96 0.086346 28.78 0.157208 52.40

Female 13

- 49:

0.060562 20.19 0.100715 33.57 0.165635 55.21Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 19 of 24 

### Attachment 3. Chronic Food plus Water Residue Input file.

Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 122101 Propiconazole \ Petition 2F8135 Oil Seeds 20A \ 122101 Chronic 2F8135 Avg FT for Aggregate Aug 2013.R08 Chemical: Propiconazole RfD(Chronic): .1 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .3 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day
Date created/last modified: 09

- 04

- 2013/14:27:37 Program ver. 3.16, 03

- 08

- d

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

---------- ---- ------------------------------- ---------- ------ - ----- ------- 0101050000 1AB Beet, garden, roots 0.120000 1.000 1.000 0101050001 1AB Beet, garden, roots

- babyfood 0.120000 1.000 1.000 0101052000 1A Beet, sugar 0.120000 1.000 1.000

0101052001 1A Beet, sugar

- babyfood 0.120000 1.000 1.000 0101053000 1A Beet, sugar, molasses 1.500000 1.000 1.000 0101053001 1A Beet, sugar, molasses

- babyfood 1.500000 1.000 1.000

0101078000 1AB Carrot 0.100000 1.000 1.000

0101078001 1AB Carrot

- babyfood 0.100000 1.000 1.000 0101079000 1AB Carrot, juice 0.100000 1.000 1.000 0200051000 2 Beet, garden, tops 5.500000 1.000 1.000 0301165000 3A Garlic, bulb 0.200000 1.000 1.000 0301165001 3A Garlic, bulb

- babyfood 0.200000 1.000 1.000 0301237000 3A Onion, bulb 0.200000 1.000 1.000

03012370 01 3A Onion, bulb

- babyfood 0.200000 1.000 1.000 0301238000 3A Onion, bulb, dried 0.200000 9.000 1.000 0301238001 3A Onion, bulb, dried

- babyfood 0.200000 9.000 1.000
0301338000 3A Shallot, bulb 0.200000 1.000 1.000 0302103000 3B Chive, fresh leaves 2.430000 1.000 1.000

0302198000 3B Leek 2.430000 1.000 1.000 0302239000 3B Onion, green 2.43000 0 1.000 1.000
0302338500 3B Shallot, fresh leaves 0.200000 1.000 1.000 0401248000 4A Parsley, leaves 3.650000 1.000 1.000

0402076000 4B Cardoon 1.010000 1.000 1.000

040208 5000 4B Celery 1.010000 1.000 1.000 0402085001 4B Celery

- babyfood 1.010000 1.000 1.000 0402086000 4B Celery, juice 1.010000 1.000 1.000

0402087000 4B Celtuce 1.010000 1.000 1.000
0402152000 4B Fennel, Florence 1.010000 1.000 1.000

0402322000 4B Rhubarb 1.010000 1.000 1.000

0402367000 4B Swiss chard 1.010 000 1.000 1.000 0600347000 6 Soybean, seed 0.260000 1.000 1.000 0600349000 6 Soybean, soy milk 0.260000 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.260000 1.000 1.000

0600 350000 6 Soybean, oil 0.260000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.260000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.700000 1.000 1.000 0601043001 6A Bean, snap, s ucculent

- babyfood 0.700000 1.000 1.000 0601349500 6AB Soybean, vegetable 0.260000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.100000 1.000 1.000 0602033000 6B Bean, cowpea, succulent 0.1 00000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.100000 1.000 1.000
0603030000 6C Bean, black, seed 0.400000 1.000 1.000 0603032000 6C Bean, broad, seed 0.400000 1.000 1.000

06 03034000 6C Bean, cowpea, seed 0.400000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.400000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.400000 1.000 1.000 0603038000 6C Bean, lima, seed 0.400000 1.000 1.000 0603039000 6C Bean, mung, seed 0.400000 1.000 1.000 0603040000 6C Bean, navy, seed 0.400000 1.000 1.000 0603041000 6C Bean, pink, seed 0 .400000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.400000 1.000 1.000 0603098000 6C Chickpea, seed 0.400000 1.000 1.000 0603098001 6C Chickpea, seed

- babyfood 0.400000 1.000 1.000 0603099000 6C Chickpea, flour 0.400000 1.000 1.000
0603182000 6C Guar, seed 0.400000 1.000 1.000 0603182001 6C Guar, seed

- babyfood 0.400000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 20 of 24 0603203000 6C Lentil, s eed 0.400000 1.000 1.000 0603348000 6C Soybean, flour 0.260000 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 0.260000 1.000 1.000

0801374000 8A Tomatillo 0.791000 1.000 1.000

0801375000 8A Tomato 0.791000 1.000 1.000

0801375001 8A Tomato

- babyfood 0.791000 1.000 1.000 0801376000 8A Tomato, paste 0.791000 5.400 1.000 0801376001 8A Tomato, paste

- babyfood 0.791000 5.400 1.000 0801377000 8A Tomato, puree 0.791000 3.300 1.000 0801377001 8A Tomato, puree

- babyfood 0.791000 3.300 1.000
0801378000 8A Tomato, dried 0.791000 14.300 1.000 0801378001 8A Tomato, dried

- babyfood 0.791000 14.300 1.000 0801379000 8A Tomato, juice 0.791000 1.500 1.000

1001106000 10A Citron 2.340000 1.000 1.000 1001107000 10A Citrus hybrids 2.340000 1.000 1.000 1001108000 10A Citrus, oil 1000. 1.000 1.000 1001240000 10A Orange 2.340000 1.000 1.00 0 1001241000 10A Orange, juice 2.340000 1.000 1.000 1001241001 10A Orange, juice

- babyfood 2.340000 1.000 1.000 1001242000 10A Orange, peel 2.340000 1.000 1.000 1001369000 10A Tange rine 2.340000 1.000 1.000 1001370000 10A Tangerine, juice 2.340000 1.000 1.000 1002197000 10B Kumquat 2.340000 1.000 1.000

1002199000 10B Lemon 1.790000 1.000 1.000 1002200000 10B Lemon, juice 1.790000 1.000 1.000 1002200001 10B Lemon, juice

- babyfood 1.790000 1.000 1.000 1002201000 10B Lemon, peel 1.790000 1.000 1. 000

1002206000 10B Lime 2.340000 1.000 1.000 1002207000 10B Lime, juice 2.340000 1.000 1.000 1002207001 10B Lime, juice

- babyfood 2.340000 1.000 1.000

1003180000 10C Gra pefruit 1.180000 1.000 1.000 1003181000 10C Grapefruit, juice 1.180000 1.000 1.000

1003307000 10C Pummelo 1.180000 1.000 1.000 1201090000 12A Cherry 0.563000 1.000 1.000 1201090001 12A Cherry

- babyfood 0.563000 1.000 1.000 1201091000 12A Cherry, juice 0.563000 1.500 1.000 1201091001 12A Cherry, juice

- babyfood 0.563000 1.500 1.000 1202012000 12B Apricot 0.961000 1.000 1.000 1202012001 12B Apricot

- babyfood 0.961000 1.000 1.000 1202013000 12B Apricot, dried 0.961000 6.000 1.000

1202014000 12B A pricot, juice 0.961000 1.000 1.000 1202014001 12B Apricot, juice

- babyfood 0.961000 1.000 1.000

1202230000 12B Nectarine 0.961000 1.000 1.000

1202260000 12B Peach 0.961000 1.000 1.000

1202260001 12B Peach

- babyfood 0.961000 1.000 1.000 1202261000 12B Peach, dried 0.961000 7.000 1.000 1202261001 12B Peach, dried

- babyfood 0.961000 7.000 1.000 1202262000 12B Peach, juice 0.961000 1.000 1.000 1202262001 12B Peach, juice

- babyfood 0.961000 1.000 1.000

1203285000 12C Plum 0.183000 1.000 1.000

1203285001 12C Plum

- babyfood 0.183000 1.000 1.000 1203286000 12C Plum, prune, fresh 0.183000 1.000 1.000 1203286001 12C Plum, prune, fresh

- babyfood 0.183000 1.000 1.000 1203287000 12C Plum, prune, dried 0.183000 5.000 1.000 1203287001 12C Plum, prune, dried

- babyfood 0.183000 5.000 1.000 1203288000 12C Plum, prune, juice 0.183000 1.400 1.000 1203288001 12C Plum, prune, juice

- babyfood 0.183000 1.4 00 1.000 1301055000 13A Blackberry 0.360000 1.000 1.000 1301056000 13A Blackberry, juice 0.360000 1.000 1.000 1301056001 13A Blackberry, juice

- babyfood 0.360000 1.000 1.000

1301058000 13 A Boysenberry 0.360000 1.000 1.000 1301208000 13A Loganberry 0.360000 1.000 1.000 1301320000 13A Raspberry 0.360000 1.000 1.000 1301320001 13A Raspberry

- babyfood 0.360000 1.000 1.000 1301321000 13A Raspberry, juice 0.360000 1.000 1.000 1301321001 13A Raspberry, juice

- babyfood 0.360000 1.000 1.000 1302057000 13B Blueberry 0.350000 1 .000 1.000 1302057001 13B Blueberry

- babyfood 0.350000 1.000 1.000

1302136000 13B Currant 0.360000 1.000 1.000 1302137000 13B Currant, dried 0.360000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 21 of 24 1302149000 13B Elderberry 0.360000 1.000 1.000 1302174000 13B Gooseberry 0.360000 1.000 1.000 1302191000 13B Huckleberry 0.360000 1.000 1.000 1307130000 13G Cranberry 0.320000 1.000 1.000 1307130001 13G Cranberry

- babyfood 0.320000 1.000 1.000 1307131000 13G Cranberry, dried 0.320000 1.000 1.000 1307132000 13G Cranberry, juice 0.320000 1.100 1.000 1307132001 13G Cranberry, juice

- babyfood 0.320000 1.100 1.000 1307359000 13G Strawberry 0.350000 1.000 1.000 1307359001 13G Strawberry

- babyfood 0.350000 1.000 1.000

130736000 0 13G Strawberry, juice 0.350000 1.000 1.000 1307360001 13G Strawberry, juice

- babyfood 0.350000 1.000 1.000

1400003000 14 Almond 0.038000 1.000 1.000

1400003001 14 Almond

- babyfood 0.038000 1.000 1.000 1400004000 14 Almond, oil 0.038000 1.000 1.000 1400004001 14 Almond, oil

- babyfood 0.038000 1.000 1.000

1400059000 14 Brazil nut 0.100000 1.000 1.000

1400068000 14 Butternut 0.100000 1.000 1.000

1400081000 14 Cashew 0.100000 1.000 1.000

1400092000 14 Chestnut 0.100000 1.000 1.000

1400155 000 14 Hazelnut 0.100000 1.000 1.000 1400156000 14 Hazelnut, oil 0.100000 1.000 1.000 1400185000 14 Hickory nut 0.100000 1.000 1.000

1400213000 14 Macadamia nut 0.100000 1.000 1.000

1400269000 14 Pecan 0.100000 1.000 1.000

1400282000 14 Pistachio 0.100000 1.000 1.000

1400391000 14 Walnut 0.1000 00 1.000 1.000 1500025000 15 Barley, pearled barley 3.000000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 3.000000 1.000 1.000 1500026000 15 Barley, flour 3.000000 1.000 1.000

15000 26001 15 Barley, flour

- babyfood 3.000000 1.000 1.000 1500027000 15 Barley, bran 6.000000 1.000 1.000 1500120000 15 Corn, field, flour 0.036000 1.000 1.000 1500120001 15 Corn, field, f lour

- babyfood 0.036000 1.000 1.000 1500121000 15 Corn, field, meal 0.036000 1.000 1.000
1500121001 15 Corn, field, meal

- babyfood 0.036000 1.000 1.000 1500122000 15 Corn, field, bran 0.03 6000 1.000 1.000 1500123000 15 Corn, field, starch 0.036000 1.000 1.000 1500123001 15 Corn, field, starch

- babyfood 0.036000 1.000 1.000 1500124000 15 Corn, field, syrup 0.036000 1.500 1.000

150 0124001 15 Corn, field, syrup

- babyfood 0.036000 1.500 1.000 1500125000 15 Corn, field, oil 0.036000 1.000 1.000 1500125001 15 Corn, field, oil

- babyfood 0.036000 1.000 1.000 1500126000 15 Corn, pop 0.036000 1.000 1.000 1500127000 15 Corn, sweet 0.100000 1.000 1.000
1500127001 15 Corn, sweet

- babyfood 0.100000 1.000 1.000 1500231000 15 Oat, bran 6. 000000 1.000 1.000
1500232000 15 Oat, flour 3.000000 1.000 1.000 1500232001 15 Oat, flour

- babyfood 3.000000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 3.000000 1.000 1.000

1 500233001 15 Oat, groats/rolled oats

- babyfood 3.000000 1.000 1.000 1500323000 15 Rice, white 1.490000 1.000 1.000 1500323001 15 Rice, white

- babyfood 1.490000 1.000 1.000 1500324000 15 Rice, brow n 1.490000 1.000 1.000 1500324001 15 Rice, brown

- babyfood 1.490000 1.000 1.000 1500325000 15 Rice, flour 1.490000 1.000 1.000 1500325001 15 Rice, flour

- babyfood 1.490000 1.000 1.000 1500326000 15 Rice, bran 15.000000 1.000 1.000
1500326001 15 Rice, bran

- babyfood 15.000000 1.000 1.000 1500328000 15 Rye, grain 0.300000 1.000 1.000 1500329000 15 Rye, flour 0.300000 1.000 1.000 1500344000 15 Sorghum, grain 1.270000 1.000 1.000 1500345000 15 Sorghum, syrup 1.270000 1.000 1.000

1500381000 15 Tritical e, flour 0.043000 1.000 1.000 1500381001 15 Triticale, flour

- babyfood 0.043000 1.000 1.000 1500401000 15 Wheat, grain 0.043000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.043000 1.000 1.000 1500402000 15 Wheat, flour 0.043000 1.000 1.000
1500402001 15 Wheat, flour

- babyfood 0.043000 1.000 1.000 1500403000 15 Wheat, germ 0.043000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 22 of 24 1500404000 15 Wheat, bran 0.600000 1.000 1.000

1500405000 15 Wild rice 0.500000 1.000 1.000 1901118000 19A Cilantro, leaves 13.000000 1.000 1.000

1901118001 19A Cilant ro, leaves

- babyfood 13.000000 1.000 1.000 1901249000 19A Parsley, dried leaves 35.000000 1.000 1.000 1901249001 19A Parsley, dried leaves

- babyfood 35.000000 1.000 1.000 2001163000 20A Flax seed, oil 0.081000 0.200 1.000 2001319000 20A Rapeseed, oil 0.081000 0.200 1.000 2001319001 20A Rapeseed, oil

- babyfood 0.081000 0.200 1.000
2001336000 20A Sesame, seed 0.081000 1.000 1.0 00
2001336001 20A Sesame, seed

- babyfood 0.081000 1.000 1.000 2001337000 20A Sesame, oil 0.081000 0.200 1.000
2001337001 20A Sesame, oil

- babyfood 0.081000 0.200 1.000

2100228000 21 Mush room 0.100000 1.000 1.000
3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat

- babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dried 0.050000 1.920 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
3100047000 31 Beef, fat 0.050000 1.000 1 .000
3100047001 31 Beef, fat

- babyfood 0.050000 1.000 1.000 3100048000 31 Beef, kidney 2.000000 1.000 1.000
3100049000 31 Beef, liver 2.000000 1.000 1.000

3100049001 31 Be ef, liver

- babyfood 2.000000 1.000 1.000
3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000
3200171000 32 Goat, fat 0.050000 1.000 1.000 3200172000 32 Goat, kidney 2.000000 1.000 1.000
3200173000 32 Goat, liver 2.000000 1.000 1.000
3300189000 33 Horse, meat 0.050000 1.000 1.000 3400294000 34 Pork, kidney 0.200000 1.000 1.000 3400295000 34 Pork, liver 0.200000 1.000 1.000 3500339000 35 Sheep, meat 0.050000 1.000 1.000

3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 3500341000 35 Sheep, fat 0.050000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.050000 1.000 1.000 3500342000 35 Sheep, kidney 2.000000 1.000 1.000 3500343000 35 Sheep, liver 2.000000 1.000 1.000
3600222000 36 Milk, fat 0.050000 1.00 0 1.000 3600222001 36 Milk, fat

- baby food/infant formu 0.050000 1.000 1.000
3600223000 36 Milk, nonfat solids 0.050000 1.000 1.000 3600223001 36 Milk, nonfat solids

- baby food/in 0.050000 1.000 1.000

3600224000 36 Milk, water 0.050000 1.000 1.000 3600224001 36 Milk, water

- babyfood/infant form 0.050000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.050000 1.000 1.000
8601000000 86A Water, direct, all sour ces 0.021680 1.000 1.000 8602000000 86B Water, indirect, all sources 0.021680 1.000 1.000

9500020000 O Avocado 10.000000 1.000 1.000

9500023000 O Banana 0.200000 1. 000 1.000

9500023001 O Banana

- babyfood 0.200000 1.000 1.000 9500024000 O Banana, dried 0.200000 3.900 1.000 9500024001 O Banana, dried

- babyfood 0.200000 3.900 1.000

9500263000 O Peanut 0.200000 1.000 1.000 9500264000 O Peanut, butter 0.200000 1.890 1.000 9500265000 O Peanut, oil 0.200000 1.000 1.000 9500275000 O Peppermint 10.000000 1.000 1.000 9500276000 O Peppermint, oil 10.000000 1.000 1.000 9500279000 O Pineapple 1.030000 1.000 1.000 9500279001 O Pineapple

- babyfood 1.030000 1.000 1.000 9500280000 O Pineapple, dried 1.030000 5.000 1.000 9500281000 O Pineapple, juice 1.030000 1.000 1.000 9500281001 O Pineapple, juice

- babyfood 1.030000 1.000 1.000

9500283000 O Plantain 0.200000 1.000 1.000
9500284000 O Plantain, dried 0.200000 3.900 1.000 9500352000 O Spearmint 10.000000 1.000 1.000 9500353000 O Spearmint, oil 10.000000 1.000 1.000 9500362000 O Sugarcane, sugar 0.120000 1.000 1.000 9500362001 O Sugarcane, sugar

- babyfood 0.120000 1.000 1.000 9500363000 O Sugarcane, molasses 0.120000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 23 of 24 9500363001 O Sugarcane, molasses

- babyfood 0.120000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D 4 14627

PC Code: 122101

___________________________________________________________ ___________________________

Page 24 of 24 

### Attachment 4. Chronic Results file.

U.S. EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for PROPICONAZ OLE NHANES 2003

- 2008 2

- day

Residue file name: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM

Files \ 122101 Propiconazole \ Petition 2F8135 Oil Seeds 20A \ 122101 Chronic 2F8135 Avg FT for Aggregate Aug 2013.R08 Adjustment factor #2 used. Analysis Date 09

- 19

- 2013/09:34:27 Residue file dated: 09

- 19

- 2013/09:27:43 Reference dose (RfD, Chronic) = .1 mg/kg bw/day

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

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

Total Exposure

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

-------------------------------------- ------------- ------ ---------- Total US Population 0.007434 7.4% Hispanic 0.010070 10.1%

Non

- Hisp

- White 0.006797 6.8%

Non

- Hisp

- Black 0.007585 7.6%

Non

- Hisp

- Other 0.008733 8.7% Nursing Infants 0.006638 6.6%

Non

- Nursing Infants 0.011912 11.9%

Female 13+ PREG 0.008191 8.2%

Children 1

- 6 0.019913 19.9%

Children 7

- 12 0.009220 9.2%

Male 13

- 19 0.006519 6.5%

Female 13

- 19/NP 0.005550 5.6%

Male 20+ 0.006316 6.3% Female 20+/NP 0.005525 5.5%

Seniors 55+ 0.005523 5.5%

All Infants 0.010284 10.3%

Female 13

- 50 0.005653 5.7%

Children 1

- 2 0.023722 23.7%

Children 3

- 5 0.019125 19.1%

Children 6

- 12 0.009943 9.9%

Youth 13

- 19 0.006024 6.0%

Adults 20

- 49 0.006182 6.2%

Adults 50

- 99 0.005620 5.6%

Female 13

- 49 0.005625 5.6%

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