Propiconazole P C Co de: 122101 Dietary Exposure and Risk A ssessm ent DP Num ber: D403630



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

Office of Chemical Safety and Pollution Prevention



### MEMORANDUM



### Date: Feb ru ary 27, 2013



### SUBJEC T: Propiconazole: Acute and C hr o ni c Agg r egate Dietary (Food a nd D rinking Water) Expo sure and Ri sk Assessments fo r Cereal Gra in s

.

PC Code: 122101 Decision No.: 460659 Petition N o. : 2F7975 DP B arcode: D 403630

Ri s k Assessm e nt Ty pe : D ie ta ry assess men t TXRNo .: N /A R eg i stration No.: I 00-617 and 100-132 4 R egulatory Ac ti on: Amended Section 3 Case No.: 3 125

. CAS No.: 60207-90-1 

### MRID No.: N / A 40 CFR : § 180.434

. 

# L

Thurston G. Morton

, Chemis t

# ~ffj-- FROM: 

### Risk Assessment Branch IV Health Ef fects Division ( 7509P)



### THROUGH: Tom Bloem

,

# ._**f~** William C u tc hin, Chemi s t

# ;~ Dietary Expos ure S cie n ce Advisory Co uncil (D ESAC ) Health Effects Di v i s i on (750 9P)

And



### S u san Hummel

, Senior Sc i en ti st Eliss a Reave s, PhD

, Br anc h C hie f Risk Assessment Branch I V Health Effects Division ( 7 509 P)



### TO: H ea ther Garvie Fu ngi c id e Branch Registrati o n D i visi on (75 05P)

This document p rovi de s the Health Effec t s Di v i s i o n 's (RE D 's) d i e tary exposure risk

assess ment of the am e nd e d u se 

### of propiconazol e on cerea l grains.

P ag e I of23Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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### Executive Summary

Propiconazole acute and chronic dietary expos ure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCIDTM, Version 3.16, which incorpor ates consumption data from USDA’s National Health and Nutrition Examinati on Survey, What We Eat in America, (NHANES/WWEIA). This dietary surv ey was conducted from 2003 to 2008. The analyses were performed to support the ame nded Section 3 registra tion on cereal grains.

Attached are acute and chronic dietary risk assessments for this new use. This dietary assessment is for residues of propiconazo le and its metabolites convertible to 2,4- dichlorobenzoic acid (2,4-DCBA), expressed as propiconazole equi valents. The common metabolites- triazole, triazolylalanine (TA), triazolylacetic acid (TAA), and

t 

### riazolylpyruvic acid are also residues of concern. Sin ce these are common metabolites from several triazole pesticides, the risk assessment for triazoles will be assessed separately.

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

An acute dietary analysis fo r propiconazole residues of concern was conducted using tolerance levels and 100 %C T for all existing and proposed uses. The acute population adjusted dose (PAD) is 0.3 mg /kg/day for all population s ubgroups (includes females 13- 49 years). The results of the analysis indica te that acute risk from the dietary exposure (food and water) to propiconazole from the ex isting and proposed uses did not exceed HED’s level of concern for the general U. S. population or any population subgroup. At the 95 th 

### percentile, the exposure to the general U.S. population is 26 % of the aPAD; the highest exposed subgroup (Children 1- 2 yrs old) is 85 % of the aPAD.

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

A chronic dietary analysis for propiconazole residues of concer n was conducted using tolerance levels for some commodities, aver age field trial residues for the remaining commodities, and 100 %CT for all existing a nd proposed uses. The chronic population adjusted dose (cPAD) is 0.1 mg/kg/day. Results of the analysis indicat e that chronic risk from the dietary exposure (food and water) to propiconazole from the existing and proposed uses did not exceed HED’s level of concern for the general U.S. population or any population subgroup. The exposure to the general U.S. population is 7.4 % of the cPAD, and the most highly exposed subgroup (C hildren 1-2 yrs old) is 24 % of the cPAD.

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

The HED Carcinogenicity Peer Review Comm ittee (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: D403630 PC Code: 122101

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### I. Introduction

Propiconazole is a triazole-t ype fungicide that provides br oad spectrum disease control through inhibition of sterol biosynthesis in fungi. It is registered to Syngenta Crop Protection for the control of fungal diseases on a variety of crops. This dietary exposure assessment is for an amended use on cereal grains.

Dietary risk assessment incorpor ates 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 ha s 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 chroni c exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is gene rally concerned when estimated cancer risk exceeds one in one million. 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/E PA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment fo r propiconazole was conducted by T. Morton (DP 403182, 11/15/12).

II. Residue Information

Residue Data used for Acute and Chronic Assessments:

The acute assessment was 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 residues fo r the remaining commodities, and 100% crop treated (%CT). The existing tolerances are listed in 40 CFR §180.434. The proposed new tolerance levels used in the DEEM are presented in Table 1. DEEM default processing factors from DEEM (Version 7.81) were used for all processed commodities that do not have individual to lerances except for citrus juices which were reduced to 1 since no concentration of propiconazole residues occurred.Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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### Propiconazole existing tolerances:

§ 180.434 Propiconazole; tolerances for residues.



### (a) General . Tolerances are establis hed for the combined residues of the fungicide 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 Almond, hulls 7.0

Banana 0.2 Barley, bran 0.6 Barley, grain 0.3 Barley, hay 1.4 Barley, straw 10 Bean, dry seed 0.40 Bean, snap 0.70 Bean, succulent shelled 0.10 Beet, garden, roots 0.30 Beet, garden, tops 5.5 Beet, sugar, dried pulp 1.0 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, kidney 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, forage 12 Corn, field, grain 0.2 Corn, field, stover 30 Corn, pop, grain 0.2 Corn, pop, stover 30 Corn, sweet, forage 6.0 Corn, sweet, kernel plus cob with husks removed 0.1Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 5 of 23 Corn, sweet, stover 30 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 Grain, aspirated fractions 30 Grass, forage 0.5 Grass, hay 0.5 Grass, straw 40 Hog, kidney 0.2 Hog, liver 0.2 Horse, fat 0.05 Horse, kidney 2.0 Horse, liver 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 1.3

Milk 0.05

Mushroom 0.1 Nut, tree, group 14 0.1 Oat, forage 1.7 Oat, grain 0.3 Oat, hay 1.4 Oat, straw 10 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 Peanut, hay 20 Peppermint, tops 10.0 Pineapple 4.5 Pineapple, process residue 7.0

Pistachio 0.1

Plum 0.60 Rice, bran 15 Rice, grain 7.0Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 6 of 23 Rice, hulls 20 Rice, straw 18 Rye, bran 0.6 Rye, forage 1.7 Rye, grain 0.3 Rye, straw 10 Sheep, fat 0.05 Sheep, kidney 2.0 Sheep, liver 2.0 Sheep, meat 0.05 Sheep, meat byproducts, except liver and kidney 0.05 Sorghum, grain, forage 12 Sorghum, grain, grain 3.5 Sorghum, grain, stover 15 Soybean, forage 11 Soybean, hay 30 Soybean, seed 2.0 Spearmint, tops 10.0

Tomato 3.0 Vegetable, foliage of legume, group 7 30 Wheat, bran 0.6 Wheat, forage 1.7 Wheat, grain 0.3 Wheat, hay 1.4 Wheat, straw 10



### (b) Section 18 emergency exemptions . Time-limited tolerances are established for residues of propiconazole (1-[[2-(2,4-d ichlorophenyl)-4-propy l-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole) and its metabolites determined as 2,4-di chlorobenzoic acid and expressed as parent compound, in connectio n 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 12/31/13



### (c) Tolerances with regional registrations . A tolerance with re gional registration, as defined in § 180.1(l), is established for re sidues of 1-[[2-(2,4-dichlorophenyl)-4-propyl1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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### 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



### (d) Indirect or inadvertent residues . Tolerances are establ ished for the combined residues of the fungicide 1- [[2-(2,4-dichlorophenyl)-4-propyl -1,3-dioxolan-2-yl] methyl]- 1H-1,2,4-triazole and its metabolites dete rmined as 2,4-dichlorobenzoic acid and expressed as parent compound in or on the following commodities wh en present therein as a result of application of propiconazole to growing crops in paragraphs (a) and (c) of this section:

Commodity Parts per million Alfalfa, forage 0.1 Alfalfa, hay 0.1



### [71 FR 55306, Sept. 22, 2006, as amended at 72 FR 20439, Apr. 25, 2007; 74 FR 12613, Mar. 25, 2009; 75 FR 80346, Dec. 22, 2010; 76 FR 27268, May 11, 2011; 77 FR 38204, Jun. 27, 2012]

Table 1a. Tolerance Summary for Propiconazole for Petition 1E7892

Crop Commodity Established Tolerance

(ppm) HED Recommended Tolerance (ppm) Comments ( Correct Commodity Definition)

Tolerances under §180.434(a) to be Added Sugarcane, cane none 0.40 Data ar e adequate to support the use.

Table 1b. Tolerance Summary for Propiconazole for Petition 2F7975

Crop Commodity Proposed or Established Tolerance

(ppm) HED Recommended Tolerance (ppm) Comments ( Correct Commodity Definition)

Tolerances under §180.434(a) to be Added Barley, bran none 6 Data are adequate to support the use. Barley, grain 0.3 3 Data are adequate to support the use. Oat, grain 0.3 3 Data are adequate to support the use.Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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### 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 leaves..................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 Apricot, 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 ppm Rice.......................................1.49 ppm Sorghum..................................1.27 ppm Wheat.....................................0.043 ppm Pineapple.................................1.03 ppm Sugarcane.................................0.12 ppm



### III. Drinking Water Data

The drinking water residues used in the di etary risk assessment were provided by the Environmental Fate and Effects Divisi on (EFED) in the following memorandum: “Drinking Water Assessment for Propiconazole Uses on Florida Avocado – Section 18 Emergency Exemption” (Jim Lin, 07/15/10, D379850) and incorporated directly into this dietary assessment. Water residues were in corporated in the DEEM-FCID into the food categories “water, direct, all sources” a nd “water, indirect, all sources.”

In the case of propiconazole, turf, a previously registered crop, has the highest application rate (6.285 lb a.i./A, 8 applica tions of 0.786 lb a.i../A per ye ar with a 14-day interval between applications) ((DP 325821,328690, Date d 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 c oncentrations for propiconazole are:

55.78 ug /L for the 1 in 10 year annual peak concentra tion (acute) 21.61 ug /L for the 1 in 10 year annual mean concentration (non-cancer chronic) and 13.24 ug /L for the 30 year annual mean c oncentration (cance r chronic).

The SCI-GROW estimated ground water drinking water concentrations for propiconazole are not expected to exceed 0.64 μ g/LPropiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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### The highest estimates from surface water (acute, 55.8 ppb and chronic, 21.6 ppb) are directly entered into th e exposure model to assess the cont ributions from drinking water.

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

. IV. DEEM-FCIDTM Program and Consumption Information

Propiconazole acute and chronic dietary expos ure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCIDTM, Version 3.16, which incorpor ates consumption data from USDA’s National Health and Nutrition Examinati on 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 indi viduals over two nonconsecutive survey days. Foods “as cons umed” (e.g., apple pie) are linked to EPAdefined food commodities (e.g. apples, peeled fr uit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly ava ilable recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the en tire U.S. population a nd within population subgroups, but for acute exposure assessment are retained as i ndividual consumption events. Based on analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns and survey res pondents, HED concluded that it is most appropriate to report risk for the follo wing population subgroups: the general U.S. population, all infants (<1 year old), child ren 1-2, children 3-5, children 6-12, youth 13- 19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an es timate of the residue level in each food or food-form (e.g., orange or orange juice) on th e food commodity residue list is multiplied by the average daily consumption estimate fo r 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 av erage estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD. This procedure is performed for each population subgroup.

For acute exposure assessments, individual one -day food consumption data are used on an individual-by-individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate a nd summed to obtain a total daily pesticide exposure for a deterministic exposure asse ssment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of expos ures is expressed as a perc entage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a percapita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported forPropiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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### all tiers of analysis. However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are sp ecifically identified and noted in the risk assessment.

V. Toxicological Information

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

The HIARC also concluded that the database was adequate to characterize any potential for prenatal or postnatal risk for infants and children. Th ere is low concern for preand/or postnatal toxicity resulting from exposure to propiconazole, and no residual uncertainties were identified. The Special FQPA factor is thus 1X. The HIARC had previously determined that an acute ne urotoxicity (ACN) study was required based on neurotoxic signs in pregnant rats administered high propico nazole doses (360 mg/kg/day) during gestation. HIARC had determined that for acute (single dos e) and short-term exposure scenarios a 3X database uncertainty factor (UF DB 

### ) was adequate to account for the lack of the ACN. In September 2005 the ACN was submitted to the Agency and reviewed. The study confirms that neurotoxi c signs are observed at high doses, but there was no neuropathology and there were no e ffects on neurobehavioral parameters. Accordingly, the propiconazole risk assessm ent team determined that a developmental neurotoxicity study was not necessary and the database uncertainty factor for acute and short-term scenarios was removed.

The HED Carcinogenicity Peer Review Comm ittee (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: D403630 PC Code: 122101

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Page 11 of 23 Table 2 Summary of Toxicological 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 Population, including Infants and Children) 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 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 increased 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 Chronic RfD = 0.1 mg/kg/day

cPAD = 0.1mg/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 mainly). Cancer (oral, dermal, inhalation) Classification: Group C, possible human carcinogen, RfD approach for risk characterization. Point of Departure (POD) = A data point or an estimate d point that is derived from observed dose-response data and used to mark the beginning of extra polation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (intraspecies). UF H = potential variation in sensitivity among members of the human population (interspecies). UF DB = to account for the absence of key data (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.



### 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 Tables 3 and 4 are for the general U.S. Populati on, all infants (<1 year old), children 1-2, children 3-4, children 6-1 2, youth 13-19, females 13-49, adults 20-49, and adults 50+

years.

At the 95 th 

### percentile, the acute dietary expos ure (food and water) to general US population is 26 % of the aPAD, and the mo st highly exposed subgroup, Children 1-2 yrs old, is 85 % of the aPAD. The chronic dietar y exposure to general US population is 7.6Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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### % of the cPAD, and the most highly exposed subgroup, Children 1-2 yrs old, is 24 % of the cPAD. All the dietary risk es timates are below 100% of the PADs.

These analyses are highly conservative dietar y exposure assessments. Further refinement to the analyses could be made through the us e of anticipated residues, incorporation of percentages of crops treated w ith propiconazole, and/or monito ring data that better reflect residues at the time of consumption. Since ri sk estimates are well below HED’s level of concern, a more highly refined analys is is not needed at this time.

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

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

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

0.3 0.077562 26 All Infants (< 1 year old) 0.108099 36 Children 1-2 years old 0.253533 85 Children 3-5 years old 0.194271 65 Children 6-12 years old 0.106036 35 Youth 13-19 years old 0.073595 25 Adults 20-49 years old 0.061233 20 Adults 50+ years old 0.050898 17 Females 13-49 years old 0.060552 20



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

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

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

0.1 0.007432 7.4 All Infants (< 1 year old) 0.010280 10 Children 1-2 years old 0.023718 24 Children 3-5 years old 0.019121 19 Children 6-12 years old 0.009941 9.9 Youth 13-19 years old 0.006022 6.0 Adults 20-49 years old 0.006180 6.2 Adults 50+ years old 0.005618 5.6 Females 13-49 years old 0.005622 5.6



### VII. Characterization of Inputs/Outputs

The acute analysis assumed tolerance-le vel residues, 100% CT, and empirical or DEEM  default processing factors. The chroni c analysis assumed average field trial residues for some commodities, 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 they do not warrant the need fo r further refinement at this time.Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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### VIII. Conclusions

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

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

Population Subgroup Acute Dietary (95th Percentile) Chronic Dietary Cancer

Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD Dietary Exposure (mg/kg/day) Risk

General U.S. Population 0.077562 26 0.007432 7.4

N/A All Infants (< 1 year old) 0.108099 36 0.010280 10 Children 1-2 years old 0.253533 85 0.023718 24 Children 3-5 years old 0.194271 65 0.019121 19 Children 6-12 years old 0.106036 35 0.009941 9.9 Youth 13-19 years old 0.073595 25 0.006022 6.0 Adults 20-49 years old 0.061233 20 0.006180 6.2 Adults 50+ years old 0.050898 17 0.005618 5.6 Females 13-49 years old 0.060552 20 0.005622 5.6



### IX. List of Attachments

Attachment 1. Acute Food plus Water Residue Input file. Attachment 2. Acute Results file. Attachment 3. Chronic Food plus Water Residue Input file. Attachment 4. Chronic Results file.Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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

Filename: C:\Documents and Settings\tmorton\My Documents\MyFiles\DEEM Files\122101 Propiconazole\Petition 2F7975 Cereal Grains\122101 Acute 2F7975 Oct 2012.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: 10-16-2012/13:48:00 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 Onion, 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 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 Cardoon 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 1.000 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 1.000 0603348000 6C Soybean, flour 2.000000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 15 of 23 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 0801376000 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-babyfood 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 1001240000 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 8.000000 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 1002201000 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-babyfood 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 8.000000 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 1201091001 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, dried 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 1202261001 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 Blackberry, 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 1.300000 1.000 1.000 1302057001 13B Blueberry-babyfood 1.300000 1.000 1.000 1302136000 13B Currant 1.000000 1.000 1.000 1302137000 13B Currant, dried 1.000000 1.000 1.000 1302149000 13B Elderberry 1.000000 1.000 1.000 1302174000 13B Gooseberry 1.000000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 16 of 23 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 1.000 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 Strawberry-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 Chestnut 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 1.000 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-babyfood 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 15 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 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 1500403000 15 Wheat, germ 0.300000 1.000 1.000 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 Cilantro, leaves-babyfood 13.000000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 17 of 23 1901249000 19A Parsley, dried leaves 35.000000 1.000 1.000 1901249001 19A Parsley, dried leaves-babyfood 35.000000 1.000 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 0.050000 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 Beef, liver-babyfood 2.000000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.050000 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 1.000 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, 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 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 1.000 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 Pineapple, 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: D403630 PC Code: 122101

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Page 18 of 23 

### 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 2F7975 Oct 2012.R08 Adjustment factor #2 NOT used. Analysis Date: 10-16-2012/13:49:34 Residue file dated: 10-16-2012/13:48:00 RAC/FF intake summed over 24 hours

Run Comment: ""

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Summary calculations--per capita:

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

---------- -------- ---------- -------- ---------- -------- Total US Population: 0.077562 25.85 0.159619 53.21 0.377394 125.80 All Infants: 0.108099 36.03 0.187782 62.59 0.351549 117.18 Children 1-2: 0.253533 84.51 0.432596 144.20 0.762949 254.32 Children 3-5: 0.194271 64.76 0.353578 117.86 0.508278 169.43 Children 6-12: 0.106036 35.35 0.192413 64.14 0.418507 139.50 Youth 13-19: 0.073595 24.53 0.126481 42.16 0.195937 65.31 Adults 20-49: 0.061233 20.41 0.100175 33.39 0.186014 62.00 Adults 50-99: 0.050898 16.97 0.086386 28.80 0.157281 52.43 Female 13-49: 0.060552 20.18 0.100742 33.58 0.165680 55.23Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 19 of 23 

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

Filename: C:\Documents and Settings\tmorton\My Documents\MyFiles\DEEM Files\122101 Propiconazole\Petition 2F7975 Cereal Grains\122101 Chronic 2F7975 Avg FT for Aggregate Oct 2012.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: 10-16-2012/13:16:50 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 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 0302198000 3B Leek 2.430000 1.000 1.000 0302239000 3B Onion, green 2.430000 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 0402085000 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 1.010000 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 0600350000 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, succulent-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 0.100000 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 1.000 0603348000 6C Soybean, flour 0.260000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 20 of 23 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 1.000 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 Tangerine 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 Grapefruit 1.180000 1.000 1.000 1003181000 10C Grapefruit, juice 1.180000 1.000 1.000 1003307000 10C Pummelo 2.340000 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 Apricot, 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 1.400 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 13A 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 1.000 1302149000 13B Elderberry 0.360000 1.000 1.000 1302174000 13B Gooseberry 0.360000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 21 of 23 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 1307360000 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 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 0.036000 1.000 1.000 1500120001 15 Corn, field, flour-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 0.036000 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 1500124001 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 1500233001 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, brown 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 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 1.000 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 Cilantro, leaves-babyfood 13.000000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 22 of 23 1901249000 19A Parsley, dried leaves 35.000000 1.000 1.000 1901249001 19A Parsley, dried leaves-babyfood 35.000000 1.000 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 0.050000 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 Beef, liver-babyfood 2.000000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.050000 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 1.000 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, 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 sources 0.021610 1.000 1.000 8602000000 86B Water, indirect, all sources 0.021610 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 1.000 9500363001 O Sugarcane, molasses-babyfood 0.120000 1.000 1.000Propiconazole Dietary Exposure and Risk Assessment DP Number: D403630 PC Code: 122101

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Page 23 of 23 

### Attachment 4. Chronic Results file.

U.S. EPA Ver. 3.16, 03-08-d DEEM-FCID Chronic analysis for PROPICONAZOLE NHANES 2003-2008 2-day Residue file name: C:\Documents and Settings\tmorton\My Documents\MyFiles\DEEM Files\122101 Propiconazole\Petition 2F7975 Cereal Grains\122101 Chronic 2F7975 Avg FT for Aggregate Oct 2012.R08 Adjustment factor #2 used. Analysis Date 10-16-2012/13:35:01 Residue file dated: 10-16-2012/13:16:50 Reference dose (RfD, Chronic) = .1 mg/kg bw/day

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

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Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Population 0.007432 7.4% Hispanic 0.010068 10.1% Non-Hisp-White 0.006795 6.8% Non-Hisp-Black 0.007584 7.6% Non-Hisp-Other 0.008731 8.7% Nursing Infants 0.006637 6.6% Non-Nursing Infants 0.011907 11.9% Female 13+ PREG 0.008189 8.2% Children 1-6 0.019909 19.9% Children 7-12 0.009218 9.2% Male 13-19 0.006517 6.5% Female 13-19/NP 0.005548 5.5% Male 20+ 0.006314 6.3% Female 20+/NP 0.005523 5.5% Seniors 55+ 0.005521 5.5% All Infants 0.010280 10.3% Female 13-50 0.005651 5.7% Children 1-2 0.023718 23.7% Children 3-5 0.019121 19.1% Children 6-12 0.009941 9.9% Youth 13-19 0.006022 6.0% Adults 20-49 0.006180 6.2% Adults 50-99 0.005618 5.6% Female 13-49 0.005622 5.6%

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