Propiconazole Dietary Exposure and Risk Assessment DP Number: D426495 

PC Code: 122101 

UNITED STATES ENVIRONMENTAL PROTECTION 

AGENCY 

WASHINGTON, D.C. 20460 

Office of Chemical Safety and Pollution Prevention 

MEMORANDUM 

Date: December 1, 2015 

SUBJECT: Propiconazole: Acute and Chronic Aggregate Dietary (Food and 

Drinking Water) Exposure and Risk Assessments for the New Use of 

Propiconazole on Dill, Crop subgroup SB Leafy Brassica greens, Radish, 

Ti Palm, Watercress, and the Expansion of Fruit, stone, group 12-1 2, and 

Nut, tree, group 14-1 2. 

PC Code: 122101 

Decision No.: 496175 

DP Barcode: D426495 

Registration No.: I 00-617, I 00-1 178, I 00-1312, & 

100-1324 

Petition No.: 4E832 I Regulatory Action: Section 3 

Risk Assessment Type: Dietary assessment Case No.: 3 125. 

TXR No.: NIA CAS No.: 60207-90-1 

MRID No.: NIA 

FROM: 

THROUGH: 

40 CFR: § 180.434 

Thurston G. Morton, Chemist rj// ~/-­ Risk Assessment Branch IV (RAB / • 

Health Effects Division (HED) (7509P) 

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~ff<.i:!.. lth Scientist ~ 

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HED (7509P) 

And 

Elissa Reaves, Ph.D., Chief 

Risk Assessment Branch 4, HED (7509P) 

TO: Sidney Jackson/Barbara Madden 

Risk Integration, Minor Use Emergency Response Branch 

Registration Division (7505P) 

This document provides the HED's dietary exposure risk assessment for the new uses of 

propiconazole. 

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Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122 101 

Executive Summary 

Propiconazole acute and chronic aggregate dietary (food and drinking water) exposure 

and risk assessments were conducted using the Dietary Exposure Evaluation Model 

software with the Food Commodity Intake Database DEEM-FCTD, Version 3.16, which 

incorporates 2003-2008 consumption data from USDA's National Health and Nutrition 

Examination Survey, What We Eat in America, (NHANES/WWEIA). The analyses were 

performed to support the new uses on dill, leafy Brassica greens crop subgroup SB, 

radish, ti palm, watercress, and the expansion of fruit, stone, group 12-12, and nut, tree, 

group 14-12. 

This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 

2012.l. 

Attached are acute and chronic dietary risk assessments for these new uses. This dietary 

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

dichlorobenzoic acid (2,4-DCBA), expressed as propiconazole equivalents. The common 

metabolites- triazole, triazolylalanine (TA), triazolylacetic acid (T AA), and 

triazolylpyruvic acid are also residues of concern. Since these are common metabolites 

from several triazole pesticides and have their own toxicological endpoints, the risk 

assessment for triazoles will be assessed separately. 

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

An acute dietary analysis for propiconazole was conducted using tolerance levels and I 00 

percent crop treated(% CT) for all existing uses and the proposed new uses. The results 

of the analysis indicate that acute risk from the dietary exposure (food and drinking 

water) to propiconazole from the existing, proposed, and amended uses did not exceed 

HED's level of concern for the general U.S. population or any population subgroup. At 

the 95th percentile, the exposure to the general U.S. population is 26 % of the aPAD; the 

most highly exposure subgroup (children 1-2 year old) is 85 % of the aPAD. 

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

A chronic dietary analysis fo"t propiconazole was conducted using tolerance levels for 

some commodities, average field trial residues for the remaining commodities, and l 00 % 

CT for all existing uses and the proposed new uses. Results of the analysis indicate that 

chronic risk from the dietary exposure (food and drinking water) to propiconazole from 

the existing, proposed, and amended 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 8.0 % of the cPAD, and the most highly exposed subgroup (children 1-2 

years old) is 25 % of the cPAD. 

Page 2 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122101 

Cancer Dietary (Food and Drinking Water) Exposure Results 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 Reference Dose (RID) 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 diseases on a variety of crops. This dietary exposure 

assessment is for the requested new uses. 

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

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

acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable 

adverse health effects). This dose is referred to as the 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. 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," 2 l-JUN-2000, 

web link: http://www.regulations.gov/# ! documentDetai l;D=EP A-H Q-0 PP-2007-0780-

000 I; or see SOP 99.6 (20-AUG-1999). 

The most recent dietary risk assessment for propiconazole was conducted by T. Morton 

(DP 426895, 12/1 /15). 

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Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122101 

II. Residue Information 

Summary of Metabolites a nd Deg radates to be included in the Risk Assessment a nd Tolerance Expr ession. 

Matrix For Risk Assessment* For Tolerance Expression 

Plants Parent plus all metabolites convertible to 2,4- Parent only 

DCBA 

Rotational crop Parent plus all metabolites convertible to 2,4- Parent only 

DCBA 

Livestock: Parent plus all metabolites convertible to 2,4- Parent only 

DCBA 

Water Parent only NIA 

Note: For all triazole-containing pesticides, the triazole-containing metabolites 1,2,4-T, TA, and T AA 

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 oftriazole-derivative fungicides and 

because of differential toxicity between the metabolites and the various parent compounds, risks associated 

with exposure to 1,2,4-T and to T A!T AA are addressed in separate risk assessment documents. 

*MI = 5-[(4-chlorophenyl)methyl]-2-methoxyl-2-methyl- l-( 1 H-1 ,2,4-triazol-1-ylmethyl)- l-cyclopentanol: 

M 11 = 5-[(4-chlorophenyl)methoxyl]-2,2-dimethyl-1-( 1 H-1 ,2,4-triazol-1-ylmethyl)- 1-cyclopentanol; M 12 

= 5-[(4-chlorophenyl)methyl]-2-carboxyl-2-methyl-1-( I H-1 ,2.4-triazol-1-ylmethyl)-l-cyclopentanol: M31 

= (Is• ,3R*,5S*)-3-hydroxy-cis-metconazole; 1,2,4-T = 1 H-1 ,2,4-triazole; T AA = 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 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% CT for all commodities. 

The chronic assessment was based on tolerance-level residues for some commodities, 

average field trial residues for the remaining commodities, and I 00% CT. The existing 

tolerances are listed in 40 CFR § 180.434. DEEM default processing factors from DEEM 

(Version 7.81) were used for all processed commodities that do not have individual 

tolerances except for citrus juices which were reduced to l since no concentration of 

propiconazole residues occurred. Residues of propiconazole and metabolites do not 

concentrate in canola refined oil (processing factor of 0.2x). Cano la oil processing factor 

was used for sesame oil also. Field trial data were translated from the representative 

commodities to the non-representative commodities according to HED SOP 2000.1 : 

"Guidance for Translation of Field Trial Data from Representative Commodities in the 

Crop Group Regulation to other Commodities in Each Crop Group/Subgroup." 

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Propiconazole Dietary Exposure and Risk Assessment DP Number: D426495 

PC Code: 122 101 

New Uses and Crop Conversions associated with this petition: 

Those commodities to be added to § 180.434(a)( l) are: 

Dill weed, fresh leaves ........................................................... 30 ppm 

Dillweed, dried leaves ........................................................... 80 ppm 

Dill, seed ........................ ....... ................................................ 15 ppm 

Brassica, leafy greens, subgroup 58 ..................................... 20 ppm 

Ti palm, leaves ...................................................................... l 0 ppm 

Ti palm, roots .......................................... ........................... 0.30 ppm 

Watercress .... .............. ........... ...................................... ......... 6.0 ppm 

Fruit, stone, group 12-1 2, except plum ................................ 4.0 ppm 

Nut, tree, group 14-12 ........................................................ 0.10 ppm 

Radish, tops ................................. 0.20 ppm (9 ppm used for acute*) 

Radish, roots ............................ 0.04 ppm (0.2 ppm used for acute*) 

*propiconazole residues convertible to 2.4-dichlorobenzoic acid (2,4-DCBA) 

In addition, a tolerance of 4.0 ppm has been proposed for tea in a previous action (T. 

Morton, 426896, 1211 II 5). 

Propiconazole existing tolerances: 

§ 180.434 Propiconazole; tolerances for residues. 

(a) General . Tolerances are established for residues of propiconazole, including its 

metabolites and degradates, in or on the commodities in the table below. Compliance 

with the tolerance levels specified below is to be determined by measuring only those 

propiconazole residues convertible to 2,4-dichlorobenzoic acid (2,4-DCBA), expressed as 

the stoichiometric equivalent of propiconazole, in or on the commodities in the table 

below: 

r-- Co

--

mmo

- -

dity - - - -r-- Parts per million 

I Banana I 0.2 

jBarley, bran translated to oat bran I 6.0 

jBarley, grain [ --3.0 

!Bean, dry seed I 0.40 

ls ean, snap I 0.70 

!Bean, succulent shelled I 0. 10 

IBeet, garden, roots I 0.30 

JBeet, garden, t~ I 5.5 --r -- Beet, sugar, molasses 1.5 

jseet, sugar, roots I 0.3 

!Beet, sugar, tops ---- -- -r 10 

Page 5 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: D426495 

PC Code: 122101 

[Bushberry, subgroup 13-078 1.0 I 

lcaneberry, subgroup l-3--0-7_A _________________ ,_ _______ 1_.0 

~t.~s @ 

[Cattle, fat ~ 

tcattle, kidney 2.0 

!cattle, liver 2 01 

Cattle, meat O.~S !cattle, meat byproducts, except liver and kidney 0.05 

!Cilantro, leaves 13 --- Citrus, oil I 000 

[Corn, field, grain 0.2 

!corn. pop, grain 0.2 

!com, sweet, kernel plus cob with husks em~ 0.1 

I Fruit, citrus, group 10-10 8.0 

!Fruit, stone, group 12-.-e.-xc_e_p_t p-l-um----------------;.i--------4- .-01 

!Goat, fat -- -----------1 0.05 1 

!Goat, kidney ------ I 2.0 . 

!Goat, liver 2.0 

!Goat, meat --r o.osl 

jGoat, meat byproducts, except liver and kidney O.osl 

jHog, kidney 0.2 

[Hog, liver Q.21 

!Horse, fat I ofill 

!Horse, kidney iO 

!Horse, liver -------- I 2.0 

lr-H-o-rs_e_, -m-e-at----------------------1 0.05 

I l

i--------1 

Horse, meat byproducts, except liver and kidney 0.05 

[Leaf petioles subgroup 48 ----------1 5.0 

Low growing berry subgroup I 3-07G, except cranberry ~ I .3 JMilk ___ .;______________ ,! _____ Q.05 

jMushroom I 0.1 

INut, tree, group 14 I 0.1 

loat, grain I 3.0 

!Onion, bulb subgroup 3-07A [ 0.2 

lonion, green, subgroup 3-078 I 9.0 

!Parsley, fresh leaves I 13 

f Parsley, dried leaves ~[ 35 

Jreanut I 0.2 

lreppennint, tops I I 0.0 

jPineapple I 4.5 I 

I Pistachio I 0.1 I 

Page 6 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122 101 

--

jPlum -----, 0.60 

!Rapeseed subgroup 20A I 0.30 [RRice, 

--- bran I 15 

jRice, grain I 7.0 

!Rye, bran I 0.6 

[Rye, grain -

I 0.3 

js heep, fa t --- I 0.05 

'Sheep, kidney I 2.0 

[Sheep, liver I - 2.0 

[Sheep, meat I 0.05 

Sheep, meat byproducts, except liver and kidney I 0.05 

lsorghum, grain, grain I 3.5 

!soybean, seed I 2.0 ~----

!Spearmint, tops I 10.0 

r----

Sugarcane, cane I 0.4 

!Tomato I 3.0 

!vegetable, fo liage of legume, group 7 I 30 

Wheat, bran I 0.6 

jwheat, grain I 0.3 

(b) Section 18 emergency exemptions . Time-limited tolerances are established for 

residues of propiconazole (1-[[2-(2,4-dichlorophenyl)-4-propyl-l ,3-dioxolan-2-yl] 

methyl]-1 H-1 ,2,4-triazole) and its metabolites detem1ined 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: 

jcommodity -I Parts per millio1-1 - -r - E-;pi a~ ;;;o~o;d~tc 

~\ ca -----.---------- 0 12/31 /16 

!Nectarine 2.0 lr-----------------1-2-/3_1_/1-31 

~-------.----------- jPeach 2.0 12/3 1/ 13 

(c) Tolerances with regional registrations. A tolerance with regional registration, as 

defined in § 180. l (1), is established for residues of 1-[[2-(2, 4-dichlorophenyl)-4-propyl1,3-dioxolan-2-yl]methyl]-1 H-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 ry ___ _ I 1.0 

1

Rice, wild, grain I 0.5 

Page 7 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: D426495 

PC Code: 122101 

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, chive, shallot leaves ................ 2.43 ppm 

Parsley, fresh leaves .................. 3.65 ppm 

Crop Group 48 .................. ...... 1.01 ppm 

Soybean seed ... ......... ... ........ ... . 0.26 ppm 

Tomato ................................. 0.791 ppm 

Grapefruit.. ............................ 1.18 ppm 

Lemon ......... ..................... .... I . 79 ppm 

Lime ........................ ............ 2.34 ppm 

Orange ................................. 2.34 ppm 

Cherry .................... . ......... .... 1.08 ppm 

Apricot, nectarine, peach ............ 0.989 ppm 

Plum .................................... 0.192 ppm 

Blueberry ............................... 0.35 ppm 

Cranberries .............................. 0.32 ppm 

Other small berries ..................... 0.36 ppm 

Strawberry .... .. ......... .. .............. 0.35 ppm 

Almond .................................. 0.038 ppm 

Com, field and pop ..................... 0.036 ppm 

Rice ....................................... 1.49 ppm (rice bran used bran tolerance) 

Sorghum .................................. 1.27 ppm 

Wheat ................. .................... 0.043 ppm (wheat bran used bran tolerance) 

Pineapple ................ ......... ........ I. I I ppm 

Sugarcane ..... ........... .......... ....... 0.12 ppm 

Oilseeds .................................... 0.081 ppm 

Dill seed ....... ........................... 2.447 ppm 

Dill weed, dried leaves .. ................ 23.1 18 ppm 

Brassica leafy greens subgroup SB ..... 4.078 ppm 

Radish, tops ............................... 2.005 ppm 

Radish, roots ............................... 0.057 ppm 

Watercress .............................. .... 1.698 ppm 

The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 

2008, 2009, and 20 l 0. PDP analyzed 1279 catfish samples for propiconazole residues. 

There were no detectable propiconazole residues. As a result, residues in fish were not 

included in the assessment. 

III. Percent Crop Treated 

l 00% CT was assumed for all crops. 

IV. Drinking Water Data 

The drinking water residues used in the dietary risk assessment were provided by the 

Environmental Fate and Effects Division (EFED) in the following memorandum: 

"Drinking Water Assessment for Proposed New Uses of Propiconazole on Dill, 

Radish, Leafy Brassica Subgroup SB, Watercress, Ti palm and Crop Group 

Page 8 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122101 

conversions for Stone Fruit Group 12-12 and Tree Nut Group 14-12." (I. Abdel-Saheb, 

05/27/ 15, 0423648) and incorporated directly into this dietary assessment. This 

assessment incorporated new models implemented since the previous EDWCs. Water 

residues were directly incorporated in DEEM-FCID into the food categories "water, 

direct, all sources" and "water, indirect, all sources." 

The estimated drinking water concentrations for propiconazole are: 

37.9 ug /L for use in the acute dietary exposure assessment 

35. l ug /L for use in the chronic dietary exposure assessment. 

Table I. Estimated Drinking Water Concentrations (EDWCs) for proposed new uses and previously registered turf. 

Use on Turf New Uses 

Surface water Surface water Surface water 

2006 Modeling 2015 Modeling 2015 Modeling 

(PRZM/EXAMS)* (SWCC)** (SWCC) 

Dill Ra dis Watercre Ti Stone 

h SS Palm Fruit(l2-

12) 

Peak (ppb) 76.5 Peak (1-in-1 0 yr) 35.2 2.84 18.4 15.9 8.69 3.55 

Annual Mean (ppb) 37.5 365-day Avg ( I-in- 18.6 1.35 2.68 3.65 2.25 1.61 

10 yr) 

30-Year Mean (ppb) 26.4 Entire Simulation 14.4 1.04 1.76 2.61 1.69 1.35 

Mean 

I 

- ~ -~ 

SCI- =~~ PRZM-GW - *** - PRZM-GW -- Groundwater GROW 

EDWCs (ppb) Peak Concentration 37.9 1.84 2.47 2.47 2.47 3. 17 

(ppb) 

Post-Breakthrough 35. 1 1.66 2.23 2.23 2.23 2.85 

Mean Concentration 

0.64 (ppb) 

Entire Simulation 26.4 1.25 1.67 1.67 1.67 2.14 

Mean Concentration 

(ppb) 

• Based on PA turf scenario (highest model output). 

•• Two scenarios were run and highest model output is presented in this table. 

For the SWCC model; the following available turf scenarios \\Cre used: 

FL. and PA 

The Pennsylvania scenario gave the highest EDWCs. 

••• For the PRZ'.\l-GW model: the following available scenarios were used: 

FLpotato. FL citrus. GA coastal. ruid NCcoastal. and Wlsand. The Wlsa11d scenario gave the highest EDWCs. 

The highest estimates from ground water (acute, 37.9 ppb and chronic, 35. l ppb) are 

directly entered into the exposure model to assess the contributions from drinking water. 

Page 9 of26 

Tree Nut 

(14-12) 

4.88 

2.68 

2.36 

4.41 

3.99 

2.99 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 12210 I 

V. DEEM-FCID 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-FCID, Version 3.16, which incorporates 2003-2008 consumption data from 

USDA's National Health and Nutrition Examination Survey, What We Eat in America, 

(NHANES/WWElA). The data are based on the reported consumption of more than 

20,000 individuals over two non-consecutive survey days. Foods "as consumed" (e.g., 

apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit -

cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly 

available recipe translation files developed jointly by USDA/ ARS and EPA. For chronic 

exposure assessment, consumption data are averaged for the entire U.S. population and 

within population subgroups, but for acute exposure assessment are retained as individual 

consumption events. Based on analysis of the 2003-2008 WWEIA consumption data, 

which took into account dietary patterns and survey respondents, HED concluded that it 

is most appropriate to report risk for the following population subgroups: the general U.S. 

population, all infants ( < l 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 or orange juice) on the food commodity residue list is multiplied 

by the average daily consumption estimate for that food/food form to produce a residue 

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

with the residue intake estimates for all other food/food forms on the commodity residue 

list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg 

body weight/day and as a percent of the cPAD. This procedure is performed for each 

population subgroup. 

For 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 total daily pesticide 

exposure for a deterministic exposure assessment, or "matched" in multiple random 

pairings with residue values and then summed in a probabilistic assessment. The 

resulting distribution of exposures is expressed as a percentage of the aP AD 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 for 

all tiers of analysis. However, for tiers 1 and 2, any significant differences in user vs. per 

capita exposure and risk arc specifically identified and noted in the risk assessment. 

VI. Toxicological Information 

HED's Hazard Identification Assessment Review Committee (HIARC) concluded that 

the toxicology database for propiconazole is complete for Food Quality Protection Act 

(FQPA) assessment. Endpoints and dose response have been selected for acute and 

chronic dietary exposures. 

Page 10 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: D426495 

PC Code: 122101 

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 reference Dose (RID) approach should be used and would be 

protecti ve. 

Table I Summary of Toxicological Doses and Endpoints for Propiconazole for Use in Dietary 

Exposure Risk Assessments 

Exposure/ Point of U nccrtainty/FQPA RID, PAD, Level Study and Toxicological 

Scenario Departure Safety Factors of Concern Effects 

Acute NOA EL= UFA= !Ox Acute RfD = 0.3 Acute neurotoxicity study 

Dietary 30 UF11= IOx mg/kg/day LOA EL = I 00 mg/kg/day based 

(General mg/kg/day FQPA SF= Ix on clinical signs of toxicity 

Population, aPAD =0.3 (piloerection in one male, 

including mg/kg/day diarrhea in one female, tip toe 

Infants and gait in 3 fema les). 

Children) 

Acute NOAEL = UFA= IOx Acute RID = 0.3 Developmental Toxicity Study -

Dietary 30 UF11= !Ox mg/kg/day Rats. 

(Females 13- mg/kg/day FQPA SF= Ix LOAEL = 90 mg/kg/day based 

49 years of on increased incidence of 

age) aPAD =0.3 rudimentary ribs, un-ossified 

mg/kg/day stemebrae, as well as increased 

incidence of shortened and 

absent renal papillae and 

increased cleft palate. 

Chronic NOA EL= UFA= IOx Chronic RID = 0.1 24-month oncogenicity study Dietary (All 10 UF11= !Ox mg/kg/day on CD- I mice. 

Populations) mg/kg/day FQPA SF= Ix LOAEL = 50 mg/kg/day based 

cPAD = O.I on non-neoplastic liver effects 

mg/kg/day (increased liver weight in males 

and increase in liver lesions: 

masses/raised areas/ 

swell ings/nodular areas 

mainly). 

Cancer (oral, dermal, Classification: Group C, possible human carcinogen, RID approach for risk 

inhalation) characterization. 

Po mt of Departure (POD) = A data po mt or an estimated po mt that 1s derived from observed dose-response 

data and used to mark the beginning of extrapolation to determine risk associated with lower 

environmentally relevant human exposures. NOA EL = no observed adverse effect level. LOAEL = lowest 

observed adverse effect level. UF = uncertainty factor. UF" = extrapolation from animal to human 

(interspecies). UF11 = potential variation in sensitivity among members of the human population 

(intraspecies). UFoa = to account for the absence of key data (i.e., lack ofa critical study). FQPA SF = 

FQPA Safety Factor. PAD = population adj usted dose (a = acute, c = chronic). RID = reference dose. 

NIA = not applicable. 

VII. Results!Discussion 

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

exceeds 100% of the PAD. The DEEM-FCID analyses estimate the dietary exposure of 

the general U.S. population and various population subgroups. The results reported in 

Tables 2 and 3 are for the general U.S. Population, all infants ( <1 year old), children 1-2, 

Page 11 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: D426495 

PC Code: 122 101 

children 3-4, children 6- 12, youth 13-19, females 13-49, adults 20-49, and adults 50-99 

years old. 

At the 95111 percentile, the acute dietary exposure (food and drinking water) to the general 

US population is 26 % of the aP AD, and the exposure to the most highly exposed 

subgroup, children 1-2 years old, is 84 % of the aPAO. The chronic dietary exposure to 

the general U.S. population is 8.0 % of the cPAD, and the exposure to the most highly 

exposed subgroup, children 1-2 years old, is 25 % of the cPAD. All the dietary risk 

estimates are below 100% of the P ADs. 

These analyses are highly conservative 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 of 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 2. Results of Acute Dietary Exposu re Analysis for Food and Drinkin2 Water 

95th Percentile 

Population Sub2roup aPAD (m!?/k2/day) Exposure (m2/ k2/day) %aPAD 

General U.S. Population 0.0787 19 26 

All Infants(< I year old) 0. 111352 37 

Children 1-2 years old 0.252947 84 

Children 3-5 years old 0.193824 65 

Children 6- 12 years old 0.3 0.106303 35 

Youth 13- 19 years old 0.073978 25 

Adults 20-49 years old 0.061858 21 

Adults 50-99 years old 0.053388 18 

Females 13-49 years old 0.060911 20 1

The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and 

risk is indicated by bold text 

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

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

Population Sub2roup cPAD (mg/kg/day) Exposure (mg/kg/day) %cPAD 

General U.S. Population 0.00801 2 8.0 

All Infants(< 1 year old) 0.0 11138 11 

Children 1-2 years old 0.024493 25 

Children 3-5 years old 0.019799 20 

Children 6-12 years old 0.1 0.010409 10 

Youth 13-19 years old 0.006435 6.4 

Adults 20-49 years old 0.006739 6.7 

Adults 50-99 years old 0.006270 6.3 

Females 13-49 years old 0.006 176 6.2 1

The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and 

risk is indicated by bold text 

Page 12 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122101 

VIII. Characterization of Inputs/Outputs 

The acute analysis assumed tolerance-level residues, l 00% CT, and empirical or DEEM 

default processing factors. The chronic analysis assumed average field trial residues for 

some commodities, tolerance-level residues for the remaining commodities, I 00% 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 for further refinement at this time. 

IX. 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 population subgroups, including those comprised of infants and children. 

X. List of Attachments 

Attachment l . Acute Food plus Water Residue Input file. 

Attachment 2. Acute Results fi le. 

Attachment 3. Chronic Food plus Water Residue Input file. 

Attachment 4. Chronic Results file. 

Page 13 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: D426495 

PC Code: 122 10 I 

Attachment 1. Acute Food plus Water Residue Input file. 

Filename: C:\Users\tmorton\Documents\My Files\DEEM Files\122101 Propiconazole\Petition 

4E8321 Dill Mustard Watercress Radish\122101 Acute August 2015.R08 

Chemical: Propiconazole 

RfD(Chronic) : .l mg/kg bw/day NOEL(Chronic): O mg/kg bw/day 

RfD(Acute): .3 mg/kg bw/day NOEL(Acute): O mg/kg bw/day 

Date created/last modified: 07-27-2015/09:17:52 Program ver . 3.16, 03-08-d 

----------------------------- ----- ------------- --- --------------------------------- EPA 

Code 

Crop Def Res 

(ppm) 

Adj .Factors Comment 

Grp Commodity Name Ill 112 

0101050000 lAB Beet, garden, roots 0.300000 1.000 

0101050001 lAB Beet. garden, roots-babyfood 0.300000 1 .000 

01010S2000 lA Beet, sugar 0.300000 1.000 

01010S2001 lA Beet, sugar- babyfood 0.300000 1.000 

0101053000 lA Beet, sugar, molasses 1.500000 1.000 

01010S3001 lA Beet, sugar, molasses-babyfood 1.500000 1 .000 

0101078000 1AB Carrot o.2soooo 1.000 

0101078001 lAB Carrot-babyfood 0.250000 1.000 

0101079000 lAB Carrot, juice 0.250000 1.000 

0101314000 lAB Radish, roots 0.200000 1.000 

Full comment: What would be for parent plus metabolites 

0101316000 lAB Radish, Oriental, roots 0.200000 1 . 000 

Full comment: What would be for parent plus metabolites 

02ooos1000 2 Beet, garden, tops 5.500000 1.000 

020031SOOO 2 Radish, tops 9.000000 1.000 

Full comment: What would be for parent plus metabolites 

0200317000 2 Radish, Oriental, tops 9.000000 1.000 

Full comment: What would be for parent plus metabolites 

030116SOOO 3A Garlic, bulb 0.200000 1.000 

030116S001 JA Garlic, bulb-babyfood 0.200000 1.000 

0301237000 3A Onion. bulb 0.200000 1 .000 

0301237001 3A Onion, bulb-babyfood 0.200000 1.000 

0301238000 3A Onion, bulb, dried 0.200000 9.000 

0301238001 3A Onion, bulb, dried -babyfood 0.200000 9 . 000 

0301338000 3A Shallot, bulb 0.200000 1.000 

0302103000 3B 

0302198000 3B 

0302239000 3B 

0302338SOO JB 

0401248000 4A 

0402076000 4B 

040208SOOO 4B 

040208S001 4B 

0402086000 4B 

0402087000 4B 

0402152000 4B 

04023 22000 4B 

0402367000 4B 

0502063000 SB 

OS02070000 SB 

0502117000 SB 

OS02194000 SB 

OS02229000 SB 

OS02318000 SB 

0502389000 SB 

0600347000 6 

0600349000 6 

0600349001 6 

06003SOOOO 6 

06003 S0001 6 

0601043000 6A 

0601043001 6A 

0601349SOO 6AB 

0602031000 68 

0602033000 6B 

0602037000 6B 

0603030000 6C 

Chive, fresh leaves 

Leek 

Onion, green 

Shallot, fresh leaves 

Parsley, leaves 

Cardoon 

Celery 

Celery-baby food 

Celery, juice 

Celtuce 

Fennel, Florence 

Rhubarb 

Swiss chard 

Broccoli raab 

Cabbage, Chinese, bok choy 

Collards 

Kale 

Mustard greens 

Rape greens 

Turnip, greens 

Soybean, seed 

Soybean, soy milk 

Soybean, soy milk-babyfood or in 

Soybean, oil 

Soybean. oil-babyfood 

Bean. snap, succulent 

Bean. snap, succulent- babyfood 

Soybean, vegetable 

Bean. broad, succulent 

Bean. cowpea, succulent 

Bean, lima, succulent 

Bean, black, seed 

9.000000 

9.000000 

9.000000 

9.000000 

13.000000 

S.000000 

5.000000 

5.000000 

S.000000 

S.000000 

5.000000 

5 . 000000 

5.000000 

20.000000 

20.000000 

20.000000 

20.000000 

20.000000 

20.000000 

20.000000 

2.000000 

2.000000 

2.000000 

2.000000 

2 . 000000 

0.700000 

0.700000 

0.100000 

0.100000 

0.100000 

0.100000 

0 .4 00000 

Page 14 of26 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 .000 

1 .000 

1 . 000 

1.000 

1.000 

1.000 

1 .000 

1.000 

1.000 

1 .000 

1 . 000 

1. 000 

1.000 

1 . 000 

1. 000 

1. 000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1. 000 

1. 000 

1. 000 

1.000 

1.000 

1 .000 

1.000 

1.000 

1.000 

1.000 What w 

1. 000 What w 

1.000 

1.000 What w 

1.000 What w 

l.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1.000 

1.000 

1 .000 

1 .000 

1. 000 

1.000 

1.000 

1 .000 

1 .000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

l. 000 

1.000 

1.000 

1.000 

1. 000 

1 .000 

1.000 

1.000 

1 . 000 

1 .000 

1.000 

1.000 

1 . 000 

1.000 

1 .000 

1 . 000 
Propiconazole 

PC Code: 122101 

0603032000 6C 

0603034000 6C 

0603035000 6C 

0603036000 6C 

0603038000 6C 

0603039000 6C 

0603040000 6C 

0603041000 6C 

0603042000 6C 

0603098000 6C 

0603098001 6C 

0603099000 6C 

0603182000 6C 

06031S2001 6C 

0603348000 6C 

060334S001 6C 

OS01374000 SA 

OS01375000 SA 

OS01375001 SA 

OS01376000 SA 

OS01376001 SA 

OS01377000 SA 

OS01377001 SA 

OS0137SOOO SA 

OS0137S001 SA 

OS01379000 SA 

OS013SOOOO SA 

1001106000 lOA 

1001107000 lOA 

lOOllOSOOO lOA 

1001240000 lOA 

1001241000 lOA 

1001241001 lOA 

1001242000 lOA 

1001369000 lOA 

1001370000 lOA 

1002197000 lOB 

1002199000 lOB 

1002200000 lOB 

1002200001 lOB 

1002201000 lOB 

1002206000 lOB 

1002207000 10B 

1002207001 lOB 

10031SOOOO lOC 

10031S1000 lOC 

1003307000 lOC 

1201090000 12A 

1201090001 12A 

1201091000 12A 

1201091001 12A 

1202012000 128 

1202012001 128 

1202013000 128 

1202014 000 128 

1202014001 12B 

1202230000 12B 

1202260000 12B 

1202260001 12B 

1202261000 12B 

1202261001 12B 

1202262000 12B 

1202262001 12B 

12032S5000 12C 

12032S5001 12C 

12032S6000 12C 

12032S6001 12C 

12032S7000 12C 

1203287001 12C 

12032SSOOO 12C 

Dietary Exposure and Risk Assessment 

Bean, broad, seed 

Bean, cowpea, seed 

Bean, great northern, seed 

Bean, kidney, seed 

Bean, lima, seed 

Bean, mung, seed 

Bean, navy, seed 

Bean, pink, seed 

Bean, pinto, seed 

Chickpea, seed 

Chickpea, seed-babyfood 

Chickpea, flour 

Guar, seed 

Guar, seed-babyfood 

Soybean, flour 

Soybean, flour-babyfood 

Tomatillo 

Tomato 

Tomato -babyfood 

Tomato, paste 

Tomato, paste-babyfood 

Tomato, puree 

Tomato, puree-babyfood 

Tomato, dried 

Tomato, dried-babyfood 

Tomato, juice 

Tomato, Tree 

Citron 

Citrus hybrids 

Citrus, oil 

Orange 

Orange, juice 

Orange, juice-babyfood 

Orange, peel 

Tangerine 

Tangerine. juice 

Kumquat 

Lemon 

Lemon , juice 

Lemon, juice-babyfood 

Lemon, peel 

Lime 

Lime, juice 

Lime, juice-babyfood 

Grapefruit 

Grapefruit, juice 

Pummelo 

Cherry 

Cherry-babyfood 

Cherry, Juice 

Cherry, juice-babyfood 

Apricot 

Apricot-babyfood 

Apricot, dried 

Apricot, juice 

Apricot, juice-babyfood 

Nectarine 

Peach 

Peach-baby food 

Peach, dried 

Peach, dried-babyfood 

Peach, juice 

Peach, juice-babyfood 

Plum 

Plum-baby food 

Plum, prune, fresh 

Plum, prune, fresh-babyfood 

Plum, prune, dried 

Plum, prune, dried-babyfood 

Plum, prune, juice 

0.400000 

0.400000 

0.400000 

0.400000 

0.400000 

0.400000 

0 . 400000 

0.400000 

0 . 400000 

0.400000 

0 .4 00000 

0.400000 

0.400000 

0 . 400000 

2.000000 

2.000000 

3 .000000 

3.000000 

3.000000 

3.000000 

3.000000 

3.000000 

3.000000 

3.000000 

3 . 000000 

3.000000 

3 .000000 

S.000000 

S . 000000 

1000. 

S.000000 

S . 000000 

S.000000 

S.000000 

8.000000 

8.000000 

8.000000 

8.000000 

8.000000 

8.000000 

8.000000 

8.000000 

S.000000 

8.000000 

8.000000 

8 . 000000 

8.000000 

4 . 000000 

4.000000 

4 . 000000 

4.000000 

4 . 000000 

4.000000 

4.000000 

4.000000 

4.000000 

4 . 000000 

4.000000 

4.000000 

4.000000 

4 . 000000 

4.000000 

4.000000 

0.600000 

0.600000 

0.600000 

0 .600000 

0 . 600000 

0.600000 

0.600000 

Page 15 of26 

DP Number: 0426495 

1. 000 1.000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1.000 1 . 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1.000 1. 000 

1. 000 1. 000 

1. 000 1.000 

1.000 

1.000 

5.400 

5.400 

3.300 

3.300 

14.300 

14.300 

1.500 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 500 

1.500 

1.000 

1.000 

6 . 000 

1 .000 

1.000 

1.000 

1.000 

1.000 

7.000 

7.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

5.000 

5.000 

1. 400 

1 . 000 

1.000 

1.000 

1. 000 

1. 000 

1. 000 

1. 000 

1. 000 

1.000 

1.000 

1 . 000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1 . 000 

1.000 

1 . 000 

1.000 

1 . 000 

1.000 

1.000 

1. 000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1. 000 

1.000 

1.000 

1. 000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 
Propiconazole 

PC Code: 122101 

1203288001 12C 

1301055000 13A 

1301056000 13A 

1301056001 13A 

1301058000 13A 

1301208000 13A 

1301320000 13A 

1301320001 13A 

1301321000 13A 

1301321001 13A 

1302057000 13B 

1302057001 138 

1302136000 138 

1302137000 13B 

1302149000 138 

1302174000 13B 

1302191000 13B 

1307130000 13G 

1307130001 13G 

1307131000 13G 

1307132000 13G 

1307132001 13G 

1307359000 l3G 

1307359001 13G 

1307360000 13G 

1307360001 l3G 

14 00003000 14 

1400003001 14 

14 00004 000 14 

1400004001 14 

1400059000 14 

1400068000 14 

1400081000 14 

1400092000 14 

1400155000 14 

1400156000 14 

1400185000 14 

1400213000 14 

1400269000 14 

1400278000 14 

1400282000 14 

1400391000 14 

1500025000 15 

1500025001 15 

1500026000 15 

1500026001 15 

1500027000 15 

1500120000 15 

1500120001 15 

1500121000 15 

1500121001 15 

1500122000 15 

1500123000 15 

1500123001 15 

1500124000 15 

1500124001 15 

1500125000 1 5 

1500125001 15 

1500126000 15 

1500127000 15 

1500127001 15 

1500231000 15 

1 500232000 15 

1500232001 15 

1500233000 15 

1500233001 15 

1500323000 15 

1500323001 15 

1500324000 15 

1500324001 15 

Dietary Exposure and Risk Assessment 

Plum, prune, j uice-babyfood 

Blackberry 

Blackberry, juice 

Blackberry, juice-babyfood 

Boysenberry 

Loganberry 

Raspberry 

Raspberry-babyfood 

Raspberry, Juice 

Raspberry, juice-babyfood 

Blueberry 

Blueberry-babyfood 

Currant 

currant, dried 

Elderberry 

Gooseberry 

Huckleberry 

Cranberry 

Cranberry-babyfood 

Cranberry, dried 

Cranberry, juice 

Cranberry, juice-babyfood 

Strawberry 

Strawberry-baby food 

Strawberr y, juice 

Strawberry, juice-babyfood 

Almond 

Almond- baby food 

Almond, oil 

Almond, oil- babyfood 

Brazil nut 

Butternut 

Cashew 

Chestnut 

Hazelnut 

Hazelnut, oil 

Hickory nut 

Macadamia nut 

Pecan 

Pine nut 

Pistachio 

Walnut 

Barley, pearled barley 

Barley, pearled barley-babyfood 

Barley, flour 

Barley, flour-babyfood 

Barley, bran 

Corn, field, flour 

Corn, field, flour-babyfood 

Corn, field, mea l 

Corn, field, meal -babyfood 

Corn, field, bran 

Corn, field, starch 

Corn, field, starch-babyfood 

Corn, field, syrup 

Corn, field, syrup-babyfood 

Corn, field, oil 

Corn, field, oil-babyfood 

Corn, pop 

Corn, sweet 

Corn, sweet-babyfood 

Oat, bran 

Oat, flour 

Oat, flour-babyfood 

Oat, groats/ rolled oats 

Oat, groats/rolled oats-babyfood 

Rice, white 

Rice, white- babyfood 

Rice, brown 

Rice, brown-babyfood 

Page 16 of26 

0.600000 

1.000000 

1 . 000000 

1.000000 

1 . 000000 

1 . 000000 

1 . 000000 

1.000000 

1 . 000000 

1.000000 

1.300000 

1. 300000 

1.000000 

1.000000 

1.000000 

1 . 000000 

1.000000 

1.000000 

1.000000 

1.000000 

1.000000 

1.000000 

1 .3 00000 

1.300000 

1.300000 

1.300000 

0 .100000 

0 .100000 

0.100000 

0 .100000 

0.100000 

0.100000 

0 .100000 

0. 1 00000 

0. 1 00000 

0. 100000 

0.100000 

0.100000 

0 .100000 

0.100000 

0.100000 

0 .100000 

3.000000 

3.000000 

3 . 000000 

3.000000 

6 . 000000 

0 . 200000 

0.200000 

0.200000 

0 .2 00000 

0.200000 

0.200000 

0.200000 

0 .200000 

0.200000 

0.200000 

0 . 200000 

0 .200000 

0. 100000 

0.100000 

6 . 000000 

3.000000 

3 .000000 

3.000000 

3 . 000000 

7.000000 

7.000000 

7.000000 

7 .000000 

DP Number: 0426495 

1.400 1.000 

1. 000 1. 000 

1. 000 1 . 000 

1. 000 1. 000 

1 .000 1. 000 

1. 000 1. 000 

1 . 000 1.000 

1. 000 1.000 

1 . 000 1. 000 

1. 000 1 . 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1 . 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 l . 000 

1. 000 1. 000 

1. 1 00 1. 000 

1. 1 00 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1.000 1 . 000 

1. 000 1. 000 

1. 000 1. 000 

1.000 1.000 

1. 000 1. 000 

1. 000 1.000 

1. 000 1 . 000 

1.000 1.000 

1 . 000 1.000 

1. 000 1. 000 

1. 000 1.000 

1.000 1.000 

1. 000 1.000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1.000 

1.000 1.000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1. 000 1 . 000 

1.000 1 . 000 

1 . 000 1. 000 

1. 000 1. 000 

1. 000 1. 000 

1.000 1.000 

1.000 1.000 

1. 000 1. 000 

1.500 1 . 000 

1. 5 00 1.000 

1. 000 1. 000 

1. 000 1 . 000 

1. 000 1.000 

1. 000 1. 000 

1.000 1 . 000 

1 . 000 1.000 

1.000 1 . 000 

1. 000 1. 000 

1. 000 1. 000 

1 .000 1 . 000 

1. 000 1. 000 

1. 000 1. 000 

1.000 1.000 

1. 000 1. 000 
Propiconazole 

PC Code: 122 10 1 

1500325000 15 

1 500325001 15 

1500326000 15 

1500326001 15 

1 500328000 15 

1500329000 15 

1500344000 15 

1500345000 15 

1500381 000 1 5 

1500381001 15 

1500401000 15 

1500401001 15 

1500402000 15 

1500402001 15 

1500403000 15 

1500404000 15 

1500405000 15 

1901118000 19A 

1901118001 19A 

1901144000 19A 

1901249000 19A 

1901249001 19A 

1902143000 198 

2001163000 20A 

2001319000 20A 

2001319001 20A 

2001336000 20A 

2001336001 20A 

2001337000 20A 

2001337001 20A 

2003114001 20C 

2100228000 21 

3100044000 31 

3100044001 31 

3100045000 31 

3100046000 31 

3100046001 31 

3100047000 31 

3100047001 31 

3100048000 31 

3100049000 31 

3100049001 31 

3200169000 32 

3200170000 32 

3200171000 32 

3200172000 32 

3200173000 32 

3300189000 33 

3400294000 34 

3400295000 34 

3500339000 35 

3500339001 35 

3500340000 35 

3500341000 35 

3500341001 35 

3500342000 35 

3500343000 35 

3600222000 36 

3600222001 36 

3600223000 36 

3600223001 36 

3600224000 36 

3600224001 36 

3600225001 36 

8601000000 86A 

8602000000 86B 

9500020000 0 

9500023000 0 

9500023001 0 

9500024000 0 

Dietary Exposure and Risk Assessment 

Rice, flour 

Rice , flour-babyf ood 

Rice, bran 

Rice, bran-babyfood 

Rye, grain 

Rye, flour 

Sorghum, grain 

Sorghum, s yrup 

Triticale, flour 

Triticale, flour-babyfood 

Wheat, grain 

Wheat, grain-babyfood 

Wheat, flour 

Wheat, flour-babyfood 

Wheat, germ 

Wheat, bran 

Wild rice 

Cilancro, leaves 

Cil antro, leaves-babyfood 

Dill weed 

Parsley, dried leaves 

Par s l ey, dried l eaves-babyfood 

Dill, seed 

Flax seed, oil 

Rapeseed, oil 

Rapeseed, oil-babyfood 

Sesame, seed 

Sesame, seed-babyfood 

Sesame , oil 

Sesame, oil-babyfood 

Coconut, oil-babyfood 

Mushroom 

Beef, meat 

Beef, meat-babyfood 

Beef, meac, dried 

Beef, meat byproducts 

Beef, meat byproduccs-babyfood 

Beef, fat 

Beef, fat-babyfood 

Beef, kidney 

Beef, liver 

Beef, liver-babyfood 

Goac, meat 

Goac, meat byproducts 

Goac, fat 

Goat, kidney 

Goat, liver 

Horse, meat 

Pork, kidney 

Pork, liver 

Sheep, meat 

Sheep, meat-babyfood 

Sheep, meat bypr oducts 

Sheep, fat 

Sheep, fat-babyfood 

Sheep, kidney 

Sheep, liver 

Milk, fat 

Milk, fat -baby food/infant formu 

Milk, nonfat solids 

Milk, nonfat solids-baby food/in 

Milk, water 

Milk, wacer-babyfood/infanc form 

Milk, sugar (lactose)-baby food/ 

Water, direct, all sources Wat er, indirect , all sources 

Avocado 

Banana 

Banana-babyfood 

Banana, dried 

7.000000 

7.000000 

15.000000 

15.000000 

0 . 300000 

0.300000 

3.500000 

3.500000 

0.300000 

0. 300000 

0.300000 

0 . 300000 

0.300000 

0.300000 

0 . 300000 

0 . 600000 

0.500000 

13. 000000 

13 . 000000 

80.000000 

35 . 000000 

35.000000 

15.000000 

0.300000 

0 . 300000 

0.300000 

0.300000 

0.300000 

0.300000 

0.300000 

0.100000 

0.100000 

0.050000 

0.050000 

0 . 050000 

0.050000 

0.050000 

0.050000 

0 . 050000 

2.000000 

2.000000 

2 . 000000 

0.050000 

0.050000 

0 . 050000 

2.000000 

2.000000 

0.050000 

0.200000 

0.200000 

0.050000 

0 . 050000 

0.050000 

0.050000 

0.050000 

2 . 000000 

2.000000 

0.050000 

0.050000 

0.050000 

0.050000 

0 . 050000 

0 . 050000 

0.050000 

0.037900 

0 . 037900 

10.000000 

0.200000 

0 . 200000 

0.200000 

Page 17 of 26 

1.000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1 . 000 

1. 000 

1.000 

1 . 000 

1 . 000 

1.000 

1.000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1. 000 

1.000 

1 . 000 

1. 000 

1.000 

1 . 000 

0 . 200 

0 . 200 

0 . 200 

1 . 000 

1 . 000 

0 . 200 

0.200 

1 . 000 

l. 000 

1 . 000 

1 . 000 

1 . 920 

l. 000 

1. 000 

1 . 000 

1. 000 

1.000 

1. 000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

l. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1.000 

1 . 000 

1 . 000 

1.000 

1 . 000 

1 . 000 

1 . 000 

l. 000 

1 . 000 

1. 000 

1.000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

3.900 

DP Number: D426495 

1. 000 

1 .000 

1.000 

1.000 

1 .000 

1.000 

1 . 000 

1. 000 

1 . 000 

1.000 

1.000 

1 .000 

1 . 000 

1 .000 

1 .000 

1 .000 

1 . 000 

1. 000 

1. 000 

1.000 

1 . 000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1 . 000 

1. 000 

1.000 

1. 000 

1. 000 

1.000 

1. 000 

1 . 000 

1.000 

1 . 000 

1. 000 

1 . 000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1 . 000 

1. 000 

1.000 

1 . 000 

l. 000 

1. 000 

1.000 

1 . 000 

1.000 

1.000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

1. 000 

1.000 

1. 000 

1 . 000 

1 . 000 

1.000 

1.000 

1 . 000 

1.000 

1 . 000 

1 . 000 

1.000 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0 426495 

PC Code: 122101 

9500024001 0 Banana, dried-babyfood 0.200000 3.900 1.000 

9500111000 0 Coconut, meat 0.100000 1.000 1.000 

9500111001 0 Coconut, meat-babyfood 0.100000 1.000 1.000 

9500112000 0 Coconut, dried 0.100000 1.000 1.000 

9500113000 0 Coconut, milk 0.100000 1.000 1.000 

9500114000 0 Coconut, oil 0.100000 1.000 1.000 

9500263000 0 Peanut 0.200000 1.000 1.000 

9500264000 0 Peanut, butter 0.200000 1 . 890 1 . 000 

9500265000 0 Peanut, oil 0.200000 1.000 1.000 

9500275000 0 Peppermint 10.000000 1.000 1.000 

9500276000 0 Peppermint, oil 10 . 000000 1 .000 1.000 

9500279000 0 Pineapple 4.500000 1.000 1 . 000 

9500279001 0 Pineapple- babyfood 4.500000 1 . 000 1. 000 

9500280000 0 Pineapple, dried 4.500000 S.000 1.000 

9500281000 0 Pineapple, juice 4.500000 1.700 1.000 

9500281001 0 Pineapple, juice-babyfood 4.500000 1.700 1.000 

9500283000 0 Plantain 0.200000 1.000 1. 000 

9500284000 0 Plantain, dried 0.200000 3 . 900 1.000 

9500352000 0 Spearmint 10.000000 1.000 1.000 

9500353000 0 Spearmint, oil 10.000000 1.000 1.000 

9500362000 0 Sugarcane, sugar 0.400000 1.000 1.000 

9500362001 0 Sugarcane, sugar-babyfood 0.400000 1 . 000 1. 000 

9500363000 0 Sugarcane, molasses 0.400000 1.000 1.000 

9500363001 0 Sugarcane, molasses-babyfood 0.400000 1 . 000 1.000 

9500372000 0 Tea, dried 4.000000 8.300 1.000 To ace 

Full comment: To account for ROC in RA highest metabolite ratio 

9500373000 0 Tea, instant 4.000000 8.300 1.000 To ace 

Full comment: To account for ROC in RA highest metabolite ratio 

9500398000 0 Watercress · 6.000000 1 . 000 1. 000 

Page 18 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122101 

Attachment 2. Acute Results file. 

US EPA 

DEEM-FCID ACUTE Analysis for PROPICONAZOLE 

Residue file: 122101 Acute August 2015.R08 

Ver. 3.18, 03-08-d 

NHANES 2003-2008 2-Day 

Adjustment factor #2 used. 

Analysis Date: 08-27-2015/09:26 :43 Residue file dated: 08-27-2015/09 :14:32 

RAC/FF intake summed over 24 hours 

Run Comment : "" 

Summary calculations--per capita : 

95th Percencile 99ch Percentile 99 . 9th Percentile 

Exposure \' aRfD Exposure t aRfD Exposure t aRfD 

---·------ -------· ---------- -------- -- ------- · -------- Total us Population: 

0.078719 26.24 0.160030 53.34 0.376022 125 . 34 

All Infants: 

0 .111352 37.12 0.188073 62.69 0.357776 119.26 

Children 1-2: 

0.252947 84.32 0 .433606 144.54 0 . 757159 252 .39 

Children 3 - 5 : 

0.193824 64.61 0. 353977 117 . 99 0. 5098 72 169 .96 

Children 6-12: 

0.106303 35.43 0.192343 64 . 11 0 . 4203 57 140 . 12 

Youth 13-19: 

0.073978 24.66 0 . 126393 42.13 0.202299 67 .4 3 

Adults 20-49: 

0.061 858 20.62 0.100991 33.66 0 . 185836 61 . 95 

Adults 50 -99: 

0.053388 17.80 0 . 090404 30.13 0 . 157350 52 .45 

Female 13 -49: 

0. 060911 20.30 0.100932 33.64 0.165573 55 . 19 

FOOD ONLY 

US EPA 

DEEM-FCID ACUTE Analysis for PROPICONAZOLE 

Residue file: 122101 Acute Food Only.ROS 

Ver . 3.18, 03-08-d 

NHANES 2003-2008 2 - Day 

Adjustment factor #2 NOT used. 

Anal ysis Date: 07-27-2015 /09 : 24 :35 Residue file dated: 07- 27 -2015/09 : 18: 28 

RAC/FF inta ke summed over 24 hours 

Run Comment : " " 

=== == ===== == =~=== == ===== == ===== == =========================== === ==== == =e== == === 

Summary cal culations--per capita : 

95th Percentile 99th Percencile 99 . 9th Percentile 

Exposure t aRf D Exposure t aRfD Exposure t aRfD 

-----·---- -------- ---------- -------- ·--------- ------ -- To cal us Population: 

0. 077760 25.92 0.159032 53.01 0 . 3738 58 124.62 

All Infants: 

0 .110354 36.78 0.186049 62.02 0.356252 118 . 75 

Children 1-2: 

0 . 250714 83.57 0.433136 144 . 38 0 . 758195 25 2. 73 

Children 3-5: 

0.193230 64.41 0.350542 116 . 85 0 . 510102 170 . 03 

Children 6-12: 

0.105713 35. 24 0 .191 7 44 63.91 0 . 419511 13 9 . 84 

Youth 13-19; 

0. 073311 24.44 0.125193 41.73 0.202048 67.35 

Adulcs 20-49: 

0 . 06091 0 20.30 0 . 100207 33.40 0.184511 61. 50 

Adults 50-99: 

0.052357 17.45 0.089768 29 . 92 0.157737 52.58 

Female 13-49: 

0.060263 20.09 0.100507 33 . 50 0.164521 54 . 84 

Page 19of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122 101 

Attachment 3. Chronic Food plus Water Residue Input file. 

Filename: C:\Users\tmorton\Documents\My Files\DEEM Files\122101 Propiconazole\Petition 

4E832l Dill Mustard Watercress Radish\ 122101 Chronic Avg FT Food and Water.ROS 

Chemical: Propiconazole 

RfD(Chronic): . 1 mg/kg bw/day NOEL(Chronic): O mg/kg bw/day 

RfD(Acute): .3 mg/kg bw/day NOEL(Acute): O mg/kg bw/day 

Date created/last modified: 07 -2 7-201S/09 :13: 30 Program ver. 3.16, 03-08-d 

EPA 

Code 

Crop 

Grp Commodity Name 

Def Res 

(ppm) 

Ad j.Factors 

Ill #2 

OlOlOSOOOO lAB Beet, garden, roots 0 . 120000 1 . 000 

OlOlOSOOOl lAB Beet, garden, roots-babyfood 0 .12 0000 1.000 

01010S2000 1A Beet, sugar 0 .120000 l . 000 

0101os2001 lA Beet, sugar-babyfood 0 . 120000 l . 000 

01010S3000 lA Beet , sugar, molasses l.SOOOOO 1. 000 

01010S3001 lA Beet, sugar, molasses-babyfood l.SOOOOO 1.000 

0101078000 lAB Carrot 0 .100000 1.000 

0101078001 lAB Carrot-babyfood 0 .100000 1.000 

0101079000 l AB Carrot, juice 0.100000 1.000 

0101314000 lAB Radish, roots O. OS7000 l . 000 

Full comment: Average residue for parent and metabolites 

0101316000 lAB Radish, Oriental, roots O.OS7000 l.000 

Full comment: Average residue for parent and metabolites 

02000Sl000 2 Beet, garden, tops s.sooooo 1.000 

020031SOOO 2 Radish, tops 2.oosooo 1.000 

Full comment: Average residue for parent and metabolites 

0200317000 2 Radish, Oriental, tops 2.oosooo 1. 000 

Full comment: Average residue for parent and metabolites 

030116SOOO 3A Garlic, bulb 0 .2 00000 1.000 

030116S001 3A Garlic, bulb-babyfood 0.200000 1 . 000 

0301237000 3A Onion . bulb 0.200000 1.000 

0301237001 3A Onion , bulb- babyfood 0 . 200000 1 . 000 

0301238000 3A Onion, bulb, dried 0 . 200000 9 . 000 

0301238001 3A Onion, bulb, dried-babyfood 0 .200000 9.000 

0301338000 3A Shallot, bulb 0.200000 1.000 

0302103000 3B Chive, fresh leaves 2 .430000 1 . 000 

0302198000 3B Leek 2.430000 1 . 000 

0302239000 3B 

0302338SOO 3B 

0401248000 4A 

0402076000 4B 

0402085000 4B 

040208S001 4B 

0402086000 4B 

0402087000 4B 

04021S2000 4B 

0402322000 4B 

0402367000 4B 

OS02063000 SB 

OS02070000 SB 

OS02117000 SB 

OS02194000 SB 

OS02229000 SB 

0502318000 SB 

0502389000 SB 

0600347000 6 

0600349000 6 

0600349001 6 

06003SOOOO 6 

06003S0001 6 

0601043000 6A 

0601043001 6A 

0601349500 6AB 

0602031000 6B 

0602033000 6B 

0602037000 6B 

Onion, green 

Shallot, fresh leaves 

Parsley, leaves 

Cardoon 

Celery 

Celery-baby food 

Celery, juice 

Celtuce 

Fennel, Florence 

Rhubarb 

Swiss chard 

Broccoli raab 

Cabbage, Chinese, bok choy 

Collards 

Kale 

Mustard greens 

Rape greens 

Turnip, greens 

Soybean, seed 

Soybean, soy milk 

Soybean, soy milk-babyfood or in 

Soybean, oil 

Soybean, oil-babyfood 

Bean, snap, succulent 

Bean. snap, succulent-babyfood 

Soybean, vegetable 

Bean, broad, succulent 

Bean, cowpea. succulent 

Bean, lima, succulent 

2.430000 

2.430000 

3.650000 

1.010000 

1. 010000 

1.010000 

1.010000 

1.010000 

1 . 010000 

l . 010000 

l . 010000 

4.078000 

4.078000 

4.078000 

4.078000 

4 . 078000 

4 . 078000 

4.078000 

0 .260000 

0 . 260000 

0.260000 

0 . 260000 

0.260000 

0 . 700000 

0 .700000 

0.100000 

0.100000 

0.100000 

0.100000 

Page 20 of26 

1. 000 

1. 000 

l.000 

1 . 000 

1. 000 

1 . 000 

l . 000 

1.000 

l.000 

1.000 

1.000 

l. 000 

1.000 

1.000 

1. 000 

1 .000 

1.000 

1 . 000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1 .000 

1 . 000 

l. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1 .000 

l . 000 

1.000 

1.000 

1 . 000 

1.000 

l.000 

l.000 

1.000 

1.000 

1. 000 

l . 000 

l.000 

1. 000 

1.000 

l.000 

1.000 

1.000 

1.000 

l . 000 

1.000 

1 . 000 

1.000 

1.000 

1 . 000 

l . 000 

1. 000 

1.000 

l.000 

1.000 

1 . 000 

l . 000 

l.000 

l . 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1.000 

Comment 

Ave rag 

Ave rag 

Ave rag 

Ave rag 
Propiconazole 

PC Code: 122 101 

0603030000 6C 

0603032000 6C 

0603034000 6C 

0603035000 6C 

0603036000 6C 

060303SOOO 6C 

0603039000 6C 

0603040000 6C 

0603041000 6C 

0603042000 6C 

060309SOOO 6C 

060309S001 6C 

0603099000 6C 

06031S2000 6C 

06031S2001 6C 

060334SOOO 6C 

060334S001 6C 

OS01374000 SA 

0801375000 SA 

OS01375001 SA 

OS01376000 SA 

OS01376001 SA 

OS01377000 SA 

0801377001 SA 

OS0137SOOO SA 

OS0137S001 SA 

OS01379000 SA 

OS013SOOOO SA 

1001106000 lOA 

1001107000 lOA 

lOOllOSOOO lOA 

1001240000 lOA 

1001241000 lOA 

1001241001 lOA 

1001242000 lOA 

1001369000 lOA 

10013 70000 lOA 

1002197000 lOB 

1002199000 lOB 

1002200000 lOB 

1002200001 lOB 

1002201000 lOB 

1002206000 lOB 

1002207000 lOB 

1002207001 lOB 

1003180000 lOC 

10031Sl000 lOC 

1003307000 lOC 

1201090000 12A 

1201090001 12A 

1201091000 12A 

1201091001 12A 

1202012000 12B 

1202012001 12B 

1202013000 12B 

1202014000 12B 

1202014001 12B 

1202230000 12B 

1202260000 12B 

1202 260001 12B 

1202261000 12B 

1202261001 12B 

1202262000 12B 

1202262001 12B 

1203285000 12C 

12032S5001 12C 

12032S6000 12C 

12032S6001 12C 

12032S7000 12C 

12032S7001 12C 

Dietary Exposure and Risk Assessment 

Bean, black, seed 

Bean, broad, seed 

Bean, cowpea, seed 

Bean, great northern, seed 

Bean, kidney, seed 

Bean, lima, seed 

Bean, mung, seed 

Bean, navy, seed 

Bean, pink, seed 

Bean, pinto, s eed 

Chickpea, seed 

Chickpea, seed-babyfood 

Chickpea, flour 

Guar. seed 

Guar, seed-babyfood 

Soybean, flour 

Soybean, flour-babyfood 

Tomatillo 

Tomato 

Tomato-babyfood 

Tomato, paste 

Tomato, paste-babyfood 

Tomato, puree 

Tomato, puree -babyfood 

Tomato, dried 

Tomato, dried-babyfood 

Tomato, juice 

Tomato, Tree 

Citron 

Citrus hybrids 

Citrus, oil 

Orange 

Orange, juice 

Orange, juice-babyfood 

Orange, peel 

Tangerine 

Tangerine. juice 

Kumquat 

Lemon 

Lemon, juice 

Lemon, juice-babyfood 

Lemon, peel 

Lime 

Lime, juice 

Lime, juice- babyfood 

Gr apefruit 

Grapefruit, juice 

Pummelo 

Cherry 

Cherry-babyfood 

Cherry, Juice 

Cherry. juice-babyfood 

Apricot 

Apricot- babyfood 

Apricot, dried 

Apricot, juice 

Apricot, juice-babyfood 

Nectarine 

Peach 

Peach-baby food 

Peach. dried 

Peach. dried-babyfood 

Peach, juice 

Peach, juice-babyfood 

Plum 

Plum-babyfood 

Plum, prune, fresh 

Plum, prune, fresh-babyfood 

Plum, prune, dried 

Plum, prune. dried-babyfood 

0.400000 

0.400000 

0 .4 00000 

0.400000 

0.400000 

0.400000 

0.400000 

0.400000 

0.400000 

0. 400000 

0.400000 

0.400000 

0.400000 

0.400000 

0 .400000 

0.260000 

0.260000 

0.791000 

0.791000 

0.791000 

0.791000 

0.791000 

0.791000 

0.791000 

0.791000 

0.791000 

0.791000 

0.791000 

2.340000 

2.340000 

1000. 

2.340000 

2.340000 

2.340000 

2.340000 

2. 340000 

2.340000 

2.340000 

1.790000 

1.790000 

1 . 790000 

1.790000 

2.340000 

2.340000 

2.340000 

l.lSOOOO 

l.lSOOOO 

l.lSOOOO 

l.OSOOOO 

1.080000 

l.OSOOOO 

l.OSOOOO 

0.9S9000 

0.9S9000 

0.9S9000 

0.9S9000 

0.9S9000 

0.9S9000 

0.9S9000 

0.9S9000 

0.9S9000 

0.9S9000 

0.9S9000 

0.9S9000 

0.192000 

0.192000 

0.192000 

0.192000 

0.192000 

0.192000 

Page 2 I of26 

l. 000 

l.000 

1.000 

1 . 000 

1.000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

l. 000 

l.000 

l.000 

1.000 

1.000 

1 . 000 

1.000 

1 . 000 

1.000 

1.000 

5 . 400 

5 .400 

3 . 300 

3.300 

14.300 

14 . 300 

l . 500 

l. 000 

1.000 

1 . 000 

1 . 000 

1 .000 

1 . 000 

1 .000 

1.000 

1.000 

1.000 

l. 000 

1.000 

l. 000 

1.000 

1.000 

1 . 000 

l . 000 

1.000 

1.000 

1.000 

l. 000 

1.000 

l. 000 

1.500 

1 . 500 

l. 000 

1.000 

6 . 000 

1.000 

1.000 

1.000 

1.000 

1.000 

7.000 

7.000 

1.000 

1.000 

1.000 

1.000 

1.000 

l. 000 

5.000 

5 . 000 

DP Number: D426495 

l.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 .000 

l. 000 

1.000 

l. 000 

1.000 

1.000 

1.000 

1.000 

l.000 

1.000 

1 .000 

1.000 

l.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

l.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

l. 000 

1.000 

1.000 

1.000 

1.000 

l. 000 

1.000 

1 . 000 

1.000 

1.000 

1 .000 

1.000 

l.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1.000 
Propiconazole 

PC Code: 122 101 

1203288000 12C 

1203288001 12C 

1301055000 13A 

1301056000 l3A 

1301056001 l3A 

1301058000 l3A 

1301208000 l3A 

1301320000 13A 

1301320001 13A 

1301321000 13A 

1301321001 13A 

1302057000 l3B 

1302057001 13B 

1302136000 13B 

1302137000 13B 

1302149000 13B 

1302174000 138 

1302191000 13B 

1307130000 13G 

1307130001 13G 

1307131000 13G 

1307132000 13G 

1307132001 13G 

1307359000 13G 

1307359001 13G 

1307360000 l3G 

1307360001 13G 

1400003000 14 

1400003001 14 

1400004000 14 

1400004001 14 

1400059000 14 

1400068000 14 

1400081000 14 

1400092000 14 

1400155000 14 

1400156000 14 

1400185000 l4 

1400213000 14 

1400269000 14 

1400278000 14 

1400282000 14 

1400391000 14 

1500025000 15 

1500025001 15 

1500026000 15 

1500026001 15 

1 500027000 15 

1500120000 15 

1500120001 15 

1500121000 15 

1 500121001 15 

1500122000 15 

1500123000 15 

1500123001 15 

1500124000 15 

1500124001 15 

1500125000 15 

1500125001 15 

1500126000 15 

1500127000 15 

1500127001 15 

1500231000 15 

1500232000 15 

1500232001 15 

1500233000 15 

1500233001 15 

1500323000 15 

1500323001 15 

1500324000 15 

Dietary Exposure and !Usk Assessment 

Plum, prune, juice 

Plum, prune, juice-babyfood 

Blackberry 

Blackberry, j uice 

Blackberry, juice-babyfood 

Boysenberry 

Loganberry 

Raspberry 

Raspberry-babyfood 

Raspberry, juice 

Raspberry, juice-babyfood 

Blueberry 

Blueberry-babyfood 

Currant 

Currant, dried 

Elderberry 

Gooseberry 

Huckleberry 

Cranberry 

Cranberry-babyfood 

Cranberry, dried 

Cranberry, juice 

Cranberry, juice-babyfood 

Strawberry 

Strawberry-babyfood 

Strawberry, juice 

Strawberry, juice-babyfood 

Almond 

Almond-babyfood 

Almond, oil 

Almond, oil-babyfood 

Brazil nut 

Butternut 

Cashew 

Chestnut 

Hazelnut 

Hazelnut, oil 

Hickory nut 

Macadamia nut 

Pecan 

Pine nut 

Pistachio 

Walnut 

Barley, pearled barley 

Barley, pearled barley-babyfood 

Barley, flour 

Barley, flour-babyfood 

Barley, bran 

Corn, field. flour 

Corn, field. flour-babyfood 

Corn, field, meal 

Corn, field, meal-babyfood 

Corn, field, bran 

Corn, field, starch 

Corn, field, starch-babyfood 

Corn, field, syrup 

Corn, field, syrup-babyfood 

Corn, field, oil 

Corn. field, oil-babyfood 

Corn , pop 

Corn, sweet 

Corn, sweet -babyfood 

Oat, bran 

Oat, flour 

Oat, flour-babyfood 

Oat . groats/ rolled oats 

Oat, groats/rolled oats-babyfood 

Rice, white 

Rice, white-babyfood 

Rice, brown 

Page 22 of26 

0 .192000 

0.192000 

0.360000 

0.360000 

0 .360000 

0 .360000 

0 .360000 

0 .360000 

0 . 360000 

0 .36 0000 

0 .360000 

0 .350000 

0 . 350000 

0 .360000 

0 . 360000 

0 . 360000 

0.360000 

0 . 360000 

0 .320000 

0 .320000 

0. 320000 

0 .320000 

0 . 320000 

0.350000 

0 .350000 

0 .350000 

0 . 350000 

0.038000 

0 . 038000 

0 .038 000 

0.038000 

0.100000 

0 . 100000 

0.100000 

0. 1 00000 

0 . 100000 

0.100000 

0 .100000 

0 .100000 

0 . 100000 

0.100000 

0.100000 

0.100000 

3.000000 

3 . 000000 

3 . 000000 

3.000000 

6 . 000000 

0.036000 

0 .036000 

0 .036000 

0 .036000 

0.036000 

0.036000 

0 .036000 

0.036000 

0 .036000 

0 .036000 

0 .036000 

0 . 036000 

0 . 100000 

0 .100000 

6 . 000000 

3 .000000 

3 .000000 

3.000000 

3.000000 

1.490000 

l. 490000 

1 .4 90000 

1.400 

l. 400 

l.000 

1.000 

l.000 

1 . 000 

l. 000 

l. 000 

l. 000 

l. 000 

l . 000 

l .000 

1 .000 

1 .000 

1.000 

1 .000 

1 . 000 

1.000 

1 . 000 

1 . 000 

1.000 

1 . 100 

1.100 

1.000 

1 . 000 

1.000 

l . 000 

1.000 

1.000 

1 . 000 

l.000 

1.000 

1.000 

l.000 

l. 000 

1 .000 

l. 000 

l.000 

1.000 

l. 000 

l. 000 

l.000 

1 .000 

1 .000 

1.000 

l. 000 

l. 000 

l.000 

1 .000 

l.000 

1.000 

1 .000 

1.000 

1.000 

1 . 000 

1.500 

1.500 

l.000 

1.000 

1 .000 

1 .000 

1 .000 

1 . 000 

l. 000 

1 .000 

1 . 000 

l. 000 

l.000 

l .000 

l . 000 

DP Number: D426495 

l. 000 

1 . 000 

1. 000 

l . 000 

1 . 000 

1.000 

1.000 

1.000 

1 . 000 

l . 000 

1.000 

l. 000 

1.000 

1 . 000 

1 . 000 

l. 000 

1 . 000 

1 . 000 

1 . 000 

l . 000 

l.000 

l. 000 

l. 000 

1 . 000 

1 .000 

l.000 

1.000 

1 . 000 

1 . 000 

1.000 

1 . 000 

1.000 

1.000 

1. 000 

1.000 

1 . 000 

1.000 

l.000 

1 . 000 

1.000 

1. 000 

l.000 

l. 000 

1.000 

1 . 000 

l. 000 

l.000 

1.000 

1 . 000 

l. 000 

1 . 000 

l. 000 

l . 000 

l . 000 

1. 000 

l . 000 

1.000 

1. 000 

1.000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

l. 000 

l.000 

1.000 

1 . 000 

1.000 

1 . 000 

1.000 
Propiconazole Dietary Exposure and Risk Assessment DP Number: D426495 

PC Code: 122 101 

1500324001 1 5 Rice, brown-ba byfood 1.490000 1.000 1. 000 

1500325000 15 Rice, flour 1 . 4 90000 1.000 1. 000 

1500325001 15 Rice, flour-baby food 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 

1500381 000 15 Triticale, flour 0.043000 1.000 1.000 

1500381001 15 Triticale, flour- babyfood 0 .04 3000 1.000 1. 000 

1500401 000 15 Wheat, grain 0 . 043000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 0 . 043000 1.000 1.000 

1500402000 15 Whea t , 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 

1 500404000 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. 000 

1901144000 19A Dill weed 23 . 118000 1.000 1. 000 dried 

Full comment: dried dillweed 

1901249000 19A Parsley, dried leaves 35 . 000000 1.000 1. 000 

1901249001 19A Parsley, dried leaves-baby food 35.000000 1.000 1.000 

1902143000 19B Dill, seed 2 . 447000 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. 000 

200133 6001 20A Sesame, seed-baby food 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 

2003114001 20C Coconut, oil-babyfood 0.100000 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, k idne y 2.000000 1. 000 1. 000 

3500343000 35 Sheep. liver 2 . 000000 1 .000 1.000 

3600222000 36 Milk, fa t 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, d irect, all sources 0 . 035100 1 . 000 1.000 

8602000000 86B water, indirect , all sources 0 . 035100 1. 000 1.000 

9500020000 0 Avocado 10.000000 1.000 1 . 000 

9500023000 0 Banana 0 . 200000 1.000 1 . 000 

Page 23 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122 101 

9500023001 0 Banana -baby food 0.200000 1.000 1.000 

9500024000 0 Banana, dried 0.200000 3.900 1.000 

9500024001 0 Banana, dried-babyfood 0.200000 3.900 1.000 

9500111000 0 Coconut, meat 0.100000 1.000 1.000 

9500111001 0 Coconut, meat-babyfood 0 .100000 1.000 1 . 000 

9500112000 0 Coconut, dried 0.100000 1 .000 1. 000 

9500113000 0 Coconut, milk 0.100000 1.000 1.000 

9500114 000 0 Coconut, oil 0.100000 1 . 000 1 . 000 

95002 63000 0 Peanut 0.200000 1 . 000 1.000 

95002 64000 0 Peanut, butter 0 . 200000 l. 890 1 . 000 

9500265000 0 Peanut, oil 0.200000 1.000 1.000 

9500275000 0 Peppermint 10.000000 1 . 000 1.000 

9500276000 0 Peppermint, oil 10.000000 l .000 l.000 

9500279000 0 Pineapple l. 110000 1 . 000 1.000 

9500279001 0 Pineappl e-babyfood 1.110000 1.000 1.000 

9500280000 0 Pineapple, dried 1.110000 5 . 000 1 .000 

9500281000 0 Pineapple, j ui ce 1 . 110000 l.000 1.000 

9500281001 0 Pineapple, juice -babyfood 1.110000 1.000 1 .000 

9500283000 0 Plantain 0.200000 1 .000 1.000 

9500284000 0 Plantain, dried 0.200000 3.900 1.000 

9500352000 0 Spearmint 10.000000 1.000 1 . 000 

9500353000 0 Spearmint, oil 10.000000 1.000 l.000 

9500362000 0 Sugarcane, sugar 0.120000 1.000 1 . 000 

95003 62001 0 Sugarcane, sugar-baby food 0.120000 l . 000 l. 000 

9500363000 0 Sugarcane, molasses 0.120000 1 .000 1. 000 

9500363001 0 Sugarcane, molasses-babyfood 0.120000 1.000 1.000 

9500372000 0 Tea , dried 4.000000 8.300 1.000 To ace 

Full comment: To account for metabolite ROC in RA 

9500373000 0 Tea, instant 4.000000 8.300 1.000 To ace 

Full comment: To account for metabolite ROC in RA 

9500398000 0 Watercr ess 1.698000 1 . 000 1.000 

Page 24 of26 
Propiconazole Dietary Exposure and Risk Assessment DP Number: 0426495 

PC Code: 122 101 

Attachment 4. Chronic Results file. 

US EPA Ver. 3.16, 03-08-d 

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

Residue file name: C:\Users\tmorton\Documents\My Files\DEEM Files\122101 

Propiconazole\Petition 4E8321 Dill Mustard Watercress Radish\122101 Chronic Avg FT Food 

and Water.ROS 

Adjustment factor #2 used . 

Analysis Date 08-27-2015/09 : 22:19 Residue file dated: 08-27-2015/09:20:33 

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

Population 

Subgroup 

Total US Population 

Hispanic 

Non- Hisp-White 

Non-Hisp-Black 

Non-Hisp-Ocher 

Nursing Infants 

Non-Nursing Infancs 

Female 13+ PREG 

Children 1-6 

Children 7-12 

Male 13-19 

Female lJ-1 9/NP 

Male 20+ 

Female 20+/NP 

Seniors SS+ 

All Infants 

Female 13-50 

Children 1- 2 

Children 3-5 

Children 6-12 

Youth 13-19 

Adulcs 20 - 49 

Adults 50 -9 9 

Female 13 - 49 

Total exposure by population subgroup 

Total Exposure 

mg/kg 

body wt/day 

0 . 008012 

0.010493 

0.007374 

0.008302 

0.009390 

0.006959 

0.013004 

0 .008693 

0 . 020611 

0.009661 

0.006923 

0 . 005969 

0.006876 

0.006159 

0.006156 

0.011138 

0.006206 

0.024493 

0.019799 

0.010409 

0.006435 

0.006739 

0.006270 

0.006176 

Page 25 of26 

Percenc of 

Rfd 

8.0t 

10.5\ 

7 .4\ 

8 .3\ 

9 .4\ 

7.0t 

13.0\ 

8 . 7\ 

20.6\ 

9 . 7t 

6.9\ 

6.0\ 

6.9\ 

6.2\ 

6.2t 

11.1\ 

6.2\ 

24.5\ 

19 .8\ 

10.4\ 

6.4\ 

6.7\ 

6.3\ 

6.2\ 
Propiconazole Dietary Exposure and Risk Assessment DP Number: D426495 

PC Code: 12210 1 

Food Only 

us EPA Ver . 3.16, 03-08-d 

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

Residue file name: C:\Users\tmorton\Documents\My Files\DEEM Files\122101 

Propiconazole\ Petition 4E8321 Dill Mustard Watercress Radish\ 122101 Chronic Avg FT Food 

Only.ROS 

Adjustment factor #2 used. 

Analysis Date 08-27 -2015/09:22 : 42 Residue file dated: 08-27-2015/09:21 : 11 

Reference dose (RfD, Chronic) = .1 mg/kg bw/day 

============c========================================================= === ====== 

Total exposure by population subgroup 

Population 

Subgroup 

Total US Population 

Hispanic 

Non-Hisp-White 

Non-Hisp-Black 

Non-Hisp-Other 

Nursing Infants 

Non-Nursing Infants 

Female 13+ PREG 

Children 1-6 

Children 7-12 

Male 13 - 19 

Female 13-19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1-2 

Children 3-5 

Childre n 6-12 

Youth 13-19 

Adults 20-49 

Adults 50 - 99 

Female 13-49 

Total Exposure 

mg/ kg 

body wt/ day 

0 . 007277 

0 . 009791 

0 . 006618 

0 . 007695 

0 . 008543 

0.006294 

0 . 010560 

0 . 008001 

0.019669 

0 . 009048 

0 . 006417 

0 . 005402 

0.006191 

0 . 005387 

0 . 005445 

0 . 009243 

0 . 005475 

0 . 023432 

0.018906 

0 . 009765 

0 . 005899 

0.006006 

0 . 005545 

0.005446 

Page 26 of26 

Percent of 

Rfd 

7.3% 

9.8\ 

6 .6' 

7 . 7\ 

8.5\ 

6.H 

10.6' 

8.0\ 

19. 7\ 

9.0t 

6 .4\ 

5 .4\ 

6.2\ 

5 .4\ 

5 .4\ 

9.2\ 

5.5\ 

23 .4\ 

18.9\ 

9.8\ 

5 . 9\ 

6.0\ 

5.5\ 

5 .4\