Di fenoconazole 

PC Code: 128847 

Dietary Exposure Assessment DP#: 42649 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Office of Chemical Safety and Pollution Prevention 

MEMORANDUM 

Date: 1-J uly-20 15 

Subject: Difenoconazole. Acute and Chronic Aggregate Dietary Exposure and Risk 

Assessments for the Petition for Use of Oifenoconazole on Globe Artichoke, Ginseng 

and Greenhouse Grown Cucumbers and Conversion of the Established Foliar 

Uses/Tolerances for Stone Fruit and Tree Nut Crop Groups to Fruit, Stone, Group 12-

!? - an d t l 1e N T ut, ree, G roup 14 -!? -· PC Code: 128847 DP Barcode: 426491 

Decision No.: 491006 Registration No.: 100-1262, 100-1313, 100-

1317 

Petition Nos.: 4E8274 Regulatory Action: Amended Section 3 

Assessment Type: Single Chemical, Dietary Registration Case No.: NA 

TXR No.: None CAS No.: 11 9446-68-3 

MRID No.: None 40 CFR: 180.475 

Reviewer: Thurston G. Morton, Chemist ~A,,,,cr­ Risk Assessment Branch IV/Health Effects Division (RABJV/HED; 7509P) 

Through: ldeliz Negr6n-Encarnaci6n, Chemist ~ .__ ___ _ 

N

Dietary 

ancy D

Exposure 

odd, Chem

Sc

is

ie

t 

nce 

~ 

Advi~ Co

~ 

uncil (DESAC) 

And 

Charles Smith, Acting Branch Chie 

RABIV /HED (7509P) 

To: Ivan Nieves, Risk Assessor 

RABIV/HED (7509P) 

And 

Tony Kish (RM 22) 

Fungicide Branch 

Registration Division (7505P) 

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Difenoconazole 

PC Code: 128847 

Executive Summary 

Dietary Exposure Assessment DP#: 426491 

Difenoconazole acute and chronic dietary exposure and risk assessments were conducted using 

the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database 

(DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the 

U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, 

What We Eat in America, (NHANES/WWElA). The analyses were performed to support the 

Section 3 registration on ginseng, globe artichoke, and the expansion to crop group 12-12 and 14-

12 of the fungicide difenoconazole [ l -[2-[2-chloro-4-( 4-chlorophenoxy) phenyl]-4-methyl-1 ,3-

dioxolan-2-ylmethyl]-1 H-1,2,4-triazole]. 

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

2012.1. 

The unrefined acute analysis assumed tolerance-level residues, I 00% crop treated (CT), and the 

available empirical or DEEM (ver. 7.81) default processing factors. The somewhat refined 

chronic analysis assumed tolerance-level residues for some commodities, average field trial 

residues and USDA Pesticide Data Program monitoring samples for the remaining commodities, 

the available empirical or DEEM (ver. 7.81) default processing factors, and% CT assumptions 

for some commodities. The EDWC of20.0 μg/L (ppb) was used for the acute dietary exposure 

analysis and an estimated drinking water concentrations (EDWC) of 13.6 μg/L (ppb) was used 

for the chronic dietary exposure analysis. 

The resulting acute food plus water dietary exposure estimates were less than HED's level of 

concern (< I 00% of the acute population-adjusted dose (aPAD)) at the 95th percentile of the 

exposure distribution for the general U.S. population ( 15% a PAD) and all population sub-groups; 

the most highly exposed population subgroup was children 1-2 years old with 49% aP AD. The 

resulting chroni c food plus water dietary exposure estimates were less than HED's level of 

concern (<100% of the chronic population-adjusted dose (cPAD)) for the general U.S. population 

(26% cPAD) and all population sub-groups; the most highl y exposed population subgroup was 

children I - 2 years old with 89% cPAD. No cancer analysis was performed since it was 

determined the chronic dietary exposure assessment is protective of cancer effects. 

The dietary exposure analyses for the triazole metabolites was recently updated (D426492, 

T. Morton, 4/ 9/15). 

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Difenoconazole 

PC Code: 128847 

I. Introduction 

Dietary Exposure Assessment DP#: 426491 

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 the 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 Pesti cides, A User's Guide," 2 l-JUN-2000, web link: 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-l 2/6061.pdf; or see SOP 99.6 (20-AUG1999). 

The most recent dietary risk assessment for di fenoconazole was conducted by T. Morton ( l 5-

January-2015; DP#4 128 12). 

II. Residue Information 

Difenoconazole tolerances are published in 40 CFR§180.475. 

Residues of Concern in Plants and Livestock: 

Residues of concern were determined based on recommendations from the HED Residues of 

Concern Knowledgebase Sub-committee (ROCKS) (D391350, 9/19/ 11 ). The residue of concern 

for plant commodities for tolerance expression and risk assessment purposes is difenoconazole 

per se. The HED ROCKS has determined that the parent compound and the CGA-205375 

metabolite are the residues of concern in livestock commodities for both the tolerance expression 

and the risk assessment. In addition, metabolite OH-CGA-169374, which comprised 15% of the 

TRR in goat milk, should be considered as a residue of concern for the dietary risk assessment. 

Based on available goat metabolism data in milk, total residues of concern for dietary risk 

assessments, should be calculated by multiplying the tolerance in milk by a factor of l .5x to 

account for the metabolite OH-CGA-1 69374. Table I summarizes tolerance expression and the 

residues of concern in plant and livestock commodities. 

rrable I. Difenoconazole Residues of Concern in Plants a nd Ruminants. 

Matrix Residues of Concern 

For Risk Assessment For Tolerance Exoression 

Plants Primary and Rotational crops Parent Only Parent Onlv 

Livestock Ruminant and Poultry Parent and CGA 205375 Parent and CGA 205375 

Milk Parent. CGA 205375, and Parent and CGA 205375 

OH-CGA-169374 

Drinking Water Parent Only NA 

Note: The 1riazole-containing metabolites 1,2,4-T, TA. and TAJ\ should be included in the residues of concern for risk 

assessment purposes only for plant and livestock commodities. Since these metabolites are common to the entire class of 

lraizole-dcrivative fung icides and because of ditTerential toxicity between me1aboli1cs and the various parenl compounds, risks 

associated with exposure to 1,2.4-T and lo TAIT AA are addressed separately. 

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Di fenoconazole 

PC Code: 128847 

Dietary Exposure Assessment DP#: 426491 

Recommended Tolerances: Based on the residue chemistry data submitted with the previous 

petitions, HED recommended for establishment of the new food tolerances (DP# 421089, B. 

Cropp-Kohlligian, 28-January-2015). The recommended, established, and revised tolerances are 

listed in Table 2 below. 

Table 2. Tole ra nce Summa ry fo r Difenoconazole (non-feed items). 

Commodity Existing/Established New Tolerances Average Field Trial Residue 

Tolerances (ppm) (ppm) or average PDP Residue 

(ppm) 

Rapeseed crop subgroup 20A 0.10 ------ 0.10 

Brassica subgroup 5A 1.9 ............... 2013 PDP data = 708 

samples/ I detects/highest 

det of0.019 used in chronic 

for broccoli 

Cabbage = 0.029 

Brassica subgroup 58 35 ----·-- 5.10 

Citrus oil 25 ............... 25 

Fruit, citrus, group I 0 0.6 ------ 201 1/ 12 PDP data = 1426 

samples/O detects/highest 

LOO of0.005 used in 

chronic for citrus 

Grape 4.0 ................. 0.613 

2013 PDP data = 176 

samples/O detects/highest 

1/2 LOO of0.005 used in 

chronic for grape juice 

Grape, raisin 6.0 ................. 0.615 (3.5x PF) 

Nut, tree, group 14-12 0.03 ................ Almond = 0.005 

Pecan = 0.007 

Onion, bulb, subgroup 3-07 A 0.20 ................. 2011/12 PDP data = 744 

samples/O detects/highest Yi 

LOO of0.0025 used in 

chronic 

Onion, green, subgroup 3-078 6.0 ................. 6.0 

Pistachios 0.03 ................ ... 0.005 

Vegetable, cucurbit, group 9 0.7 ------ 2011/12 PDP data = 744 

samples/O detects/highest Yi 

LOO of0.0025 used in 

chronic for cantaloupe 

Cucumber = 0.055 

2011 / 12/ 13 PDP data = 

1115 samples/I 

detects/highest det of 0.0 I I 

used in chronic for 

squash/pumpkin 

Fruit, Pome, group I I 1.0 ------ Apple = 0.203 

Pear = 0.123 

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Dietary Exposure Assessment 

Table 2. Tolerance Summary for Difenoconazole (non-feed items). 

Commodity Existing/Es tab I ished New Tolerances 

Tolerances (ppm) (ppm) 

Vegetable, Fruiting, Group 8-10 0.60 ------

Vegetable, Tuberous and Conn, 4.0 ------ subgroup IC 

Beet. sugar 0.30 ____ .. _ 

Papaya 0.30 ............ 

Banana 0.2 ............. 

Barley, grain 0. 1 .............. 

Cattle fat 0.10 ------

Cattle, meat 0.05 ------ Cattle, meat byproducts 0. 10 ------

Cattle, liver 0.40 ------

Corn, sweet, kerne l plus cob 0.01 ------ with husks removed 

Cotton, undelinted seed 0.05 ------

Eoo 0.02 ............. "'"' 

Goat. fat 0.10 ............ 

Goat, meat 0.05 ............ 

Goat. meat byproducts (except 0.10 ------ liver) 

Goat, liver 0.40 .............. 

Hog, fat 0.10 ------

Hog, meat 0.05 ............. 

Hog, meat byproducts (except 0.1 ------

liver) 

Hog. liver 0.40 ------

Horse, fat 0.10 ------

Horse. meat 0.05 ------

Milk 0.02 proposed to be ............. 

increased from 0.0 I 

ppm 

Rye. grain 0.0 1 ............... 

Sheep. fat 0.10 ------

Sheep. meat 0.05 ................ 

Sheep, meat byproducts (except 0. 10 ------ liver) 

Sheep, liver 0.40 ............. 

Wheat. grain 0.1 .............. 

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DP# : 426491 

Average Field Trial Residue 

or average PDP Residue 

(ppm) 

Tomato = 0.165 

Pepper = 0.133 

Eggplant=0.133 

Okra=0.6 

1.36 

0.30 

0.30 

20 12/ 13 PDP data = 1267 

samples/O detects/highest Yi 

LOO of0.0025 used in 

chronic for banana 

0.10 

0. 10 

0.05 

0.10 

0.40 

0.0 1 

0.05 

0.02 

0.10 

0.05 

0. 10 

0.40 

0.10 

0.05 

0. 10 

0.40 

0.10 

0.05 

0.02 

0.0 1 

0.10 

0.05 

0.10 

0.40 

0.10 
Difenoconazole 

PC Code: 128847 

Dietary Exposure Assessment 

Table 2. Tolerance Summa ry for Difenoconazole (non-feed items). 

Commodity Existing/Established New Tolerances 

Tolerances (ppm) (ppm) 

Wax apple 0.07 ------

Mango 0.07 ------

Carrot 0.50 ............. 

Soybean, seed 0.15 ------ Fruit, stone, group 12- 12 2.5 ............ 

Strawberry 2.5 ------

Turnip greens 35 ............ 

Oat, grain 0.01 ------

Wax Jambu 1.5 

Dragon fruit 1.5 (translated from 

waxjambu) 

Pea and bean, dried shelled, 0.20 

except soybean, subgroup 6C 

Bushberry subgroup 13-078 4.0 

Globe Artichoke 1.5 

Ginseng 1.0 

DP#: 426491 

Average Field Trial Residue 

or average PDP Residue 

(ppm) 

0.07 

0.07 

20 13 PDP carrot data = 712 

samples/ I I detects/max 

detect of0.007 used for 

chronic 

0.02 15 

Cherry = 0.622 

20 13 PDP data = 285 

samples/6 detects/highest 

det of0.038 used in chronic 

for peach 

20 13 PDP data = 543 

samples/5 detects/highest 

det of0.004 used in chronic 

for nectarine 

2011 / 12/13 PDP dara = 

1347 samples/O 

detects/highest 1/2 LOD of 

0.0025 used in chronic for 

plum 

0.495 

5. 10 

0.01 

1.5 

1.5 

Dried bean = 0.0 14 

Dried pea = 0.034 

1.009 

0.469000 

0.316 

The dietary exposure analyses for the triazole metabolites (0426492, T. Morton, 4/ 9/15) 

was recently updated. Addition of these uses did not significantly change the dietary 

exposure for the triazole metabolites. 

Food Residues and processing factors used in the Acute and Chronic Analysis: The acute 

analysis assumed tolerance-level residues and l 00% CT for all the registered and proposed crops. 

Tolerance-level residues were also assumed for all livestock tissues in this assessment. The 

chronic analysis assumed tolerance-level residues for some commodities, average field trial 

residues and USDA PDP average residues for the remaining commodities, and% CT assumption 

for some commodities. Those commodities where field trial data were used are summarized 

below. HED SOP 2000.l Guidance for Translation of Field Trial Data from Representative 

Commodities in the Crop Group Regulation to Other Commodities in Each Crop 

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Difenoconazole 

PC Code: 128847 

Dietal)' Exposure Assessment DP#: 426491 

Group/Subgroup dated 9112/2000 was used in translating to other commodities in the crop group. 

Experimental processing factors were used for apple juice (0.04x), grape juice (0.2x), citrus 

juices (O. lx), potato chips (0.5x), potato granules/flakes (0.5x), raisin (3.5x chronic only since 

the raisin tolerance was used in acute), sugar beet molasses (0.6x), tomato paste (1.6x), and 

tomato puree (0.5x); DEEM (ver. 7 .81) default processing factors were assumed for other 

processed commodities. 

Almond: Average field trial residue was used from MRID 47586101. 

~:Average field trial residue was used from MRlD 46950233. 

Pea and Bean, Dried Shelled, Except Soybean, Subgroup 6C: Field trial residues were used from 

MRID 49227601. 

Banana: Highest LOO of 0.0025 ppm in 2012/2013 USDA PDP data used. PDP found 0 detects 

in 1267 banana samples tested. 

Broccoli: Highest residue in 2013 USDA PDP data used (0.019 ppm). PDP found l detect in 

708 samples tested. 

Bushbeny: Average field trial residue was used from MRJD 49227602. 

Cabbage: Average field trial residue was used from 47586102. Residues from 1-7 day PHI were 

used since registered labels allow from 1-7 day PHis. To refine the dietary exposure data from 

only cabbage samples without wrapper leaves were used. 

Cantaloupe: Highest LOO of0.0025 ppm in 2011 /2012 USDA PDP data used. PDP found 0 

detects in 744 cantaloupe samples tested. 

Carrot: Highest detect of 0.007 ppm in 2013 USDA PDP data used. PDP found 11 detects in 712 

carrot samples tested. 

Chickpea: Average fi eld trial residue was used from MRJD 47929805. 

Cucumber: Average field trial residue was used from MRID 47586103. Residues from 0-1 day 

PHI were used since registered labels allow from 0-1 day PHI. 

Grape: Highest LOD of 0.005 ppm in 20 I 3 USDA PDP data used for grape juice. PDP found 0 

detects in 176 grape juice samples tested. Average field trial residue from MRTD 4 7586105 used 

for grape. 

Grapefruit: Highest LOO of 0.005 ppm in 2011/20 12 USDA PDP data used. PDP found 0 

detects in 1426 citrus samples tested. 

Lemon: Highest LOO of0.005 ppm in 201 1/2012 USDA PDP data used. PDP found 0 detects in 

1426 citrus samples tested. 

Lime: Highest LOO of 0.005 ppm in 201112012 USDA POP data used. POP found 0 detects in 

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Di fenoconazole 

PC Code: 128847 

1426 citrus samples tested. 

Dietary Exposure Assessment DP#: 426491 

Mustard Greens: Average field trial residue was used from MRIDs 47417704, 474 17707, and 

47586102. Residues from 1-7 day PHI were used since registered labels allow from 1-7 day 

PHis. 

Nectarine: Highest detect of 0.004 ppm in 2013 USDA PDP data used. PDP found 5 detects in 

543 nectarine samples tested. 

Onion, bulb, subgroup 3-07 A: Highest LOO of 0.0025 ppm in 2011 /2012 USDA POP data used. 

PDP found 0 detects in 744 onion samples tested. 

Orange: Highest LOO of 0.005 ppm in 20 11 /2012 USDA PDP data used. PDP found 0 detects 

in 1426 citrus samples tested. 

Peach: Highest detect of 0.038 ppm in 2013 USDA PDP data used. PDP found 6 detects in 285 

peach samples tested. 

Pear: Average field trial residue was used from MRJD 46950233. 

Pecan: Average field trial residue was used from MRID 47586106. 

Peppers: Average field trial residue was used from MRID 46950234. 

Plum: Highest LOO of 0.0025 ppm in 2011 /20 12/2013 USDA PDP data used. PDP found 0 

detects in 134 7 plum samples tested. 

Potato: Average field trial residue was used from MRID 47929804. 

Soybean: Average field trial residue was used from MRID 47929801. 

Stone Fruit: Average field trial residue was used from MRID 47929803. 

Strawberry: Average field trial residue was used from MRID 4 7929802. 

Sugar Beet: Average field trial residue was used from MRID 46950236. 

Summer Squash: Highest detect of0.011 ppm in 20 11 /2012/2013 USDA PDP data used for 

squash and pumpkin. POP found 0 detects in 744 squash samples tested. 

Tomato: Average field trial residue was used from MRIDs 46950234, 47417705, and 47417708. 

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Difenoconazole 

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Dietary Exposure Assessment 

III. Percent Crop Treated Information 

DP#: 426491 

The acute dietary exposure analyses assumed 100% crop treated (CT). Average %CT was used 

for the following crops: almond 5%, cabbage 2.5%, cucumbers 5%, garlic 5%, grape 5%, 

grapefruit 2.5%, onions 5%, orange 2.5%, pecan 2.5%, peach 1 %, peppers 2.5%, pistachio 2.5%, 

pumpkin 2.5%, squash 5%, strawberry 2.5%, sugar beets 15%, tangerine 2.5%, tomatoes 25%, 

walnut 2.5%, watermelon 5%, and wheat 10%. 

IV. Drinking Water Data 

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

Environmental Fate and Effects Division (EFED; Memo, F. Khan, l 3-November-2014; 

0421092). The EDWCs for surface water for the requested new uses did not supersede the 

previously recommended drinking water concentrations. For surface water, revised 

recommended EDWCs are 20.0 μg/L for peak, 13.6 μg/L for annual mean and 9.9μ g/L for 

annual average concentrations. Recommended EDWCs for human health are 20.0 μg/L (ppb) for 

the acute dietary (food plus water) exposure analysis and the I -in-10 year annual mean EDWC of 

13.6 μg/L (ppb) for the chronic dietary (food plus water) exposure analysis. 

V. DEEM-FCID Program and Consumption Information 

Oifenoconazole acute and chronic dietary exposure assessments were conducted using the 

Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEMFCID, Version 3.16, which incorporates consumption data from USDA's National Health and 

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary 

survey was conducted from 2003 to 2008. The data are based on the reported consumption of 

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

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

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

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 13-1 9, 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 foodform (e.g. , orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form. The resulting residue consumption 

estimate for each food/food form is summed with the residue consumption 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 

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PC Code: 128847 

Dietary Exposure Assessment 

is performed for each population subgroup. 

DP#: 426491 

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. , those who reported eating relevant 

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

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

exposure and risk are reported for all tiers of analysis. However, for Tiers 1 and 2, significant 

differences in user vs. per capita exposure and risk are identified and noted in the risk 

assessment. 

VI. Toxicological Information 

On 08-SEP-1998, HED's Hazard Identification Assessment Review Committee (HIARC) 

evaluated the toxicology database of difenoconazole and re-assessed the RID established in 1994, 

as well as the toxicological endpoints for the dietary and occupational exposure risk assessments 

that were selected in 1994. At this meeting, the HIARC also addressed the potential enhanced 

sensitivity of infants and children from exposure to difenoconazole as required by the Food 

Quality Protection Act (FQPA) of 1996 (HED Doc. No. 012873, 25-SEP-1998). In July, 2007, 

the RAB 1 toxicologists and risk assessment team met to reevaluate the endpoints selected by the 

HIARC since new studies were submitted. RAB 1 toxicologists and risk assessment team also 

reevaluated FQPA assessments. The risk assessment team concluded that the default lOx FQPA 

Safety Factor (SF) should be reduced to lx when assessing acute and chronic dietary exposures 

(M.Sahafeyan, 0333320, 09-AUG-07). The relevant endpoints are shown in Table 3. 

In accordance with HEO's current policy and EPA's 2005 Cancer Guidelines, difenoconazole is 

classified as "Suggestive Evidence of Carcinogenic Potential," based on excessive toxicity 

observed at the two highest doses, the absence of tumors at the lower doses and the absence of 

genotoxic effects. A margin-of-exposure (MOE) approach in risk assessment was advocated by 

HED's CPRC in 1994. Use of an MOE approach was reviewed and reaffirmed in 2007 by the 

CPRC Chair (PV Shah, 3/1 /07, HED Doc. No. 0054532). Therefore, a separate cancer dietary 

assessment is not being conducted for difenoconazole. 

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Table 3. Summary of Toxicologica l Doses and Endpoints for Difenoconazole for Use in Dietary Risk 

Assessments. 

Exposure Point of Uncertainty/FQPA RID, PAD, for Risk Study and Relevant 

Scenario Departure Safety Factors Assessment Toxicological Effects 

Acute Dietary NOAEL= UFA= IOX aRfD = aPAD = 0.25 Acute Neurotoxicity Study 

(All 25 UF11 = IOX mg/kg/day in Rats 

populations) mg/kg FQPA SF = IX LOA EL= 200 mg/kg in 

males based on reduced 

fore-limb grip strength in 

males on day I. 

Chronic NOAEL= UF" = IOX cRID = cPAD = Combined chronic 

Dietary (All 0.96 UF11 = IOX 0.0 I mg/kg/day toxicity/carcinogenicity 

populations) mg/kg/day FQPA SF = IX (rat; dieta ry) LOAEL = 

24.1 /32.8 mg/kg/day (M/F) 

based on cumulative 

decreases in body-weight 

gains. 

Cancer (oral, Difenoconazole is classified as a Group C. possible human carci nogen with a non-linear (MOE) 

dem1al. approach for human risk characterization (CPRC Document, 7/27/94, Memo. P. V. Shah dated 

inhalation) March 3, 2007, HED Doc. No. 0054532). The chronic dietary exposure assessment is protective of 

cancer effects. 

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

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

exposures. NOA EL = no observed adverse effect level. LOAEL = lowest observed adverse efTect level. UF = 

uncertainty factor. UF,, = extrapolation from animal to human (interspecies). UFn = potential variation in sensitivity 

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

adjusted dose (a = acute, c = chronic). RID = reference dose. 

VII. Results/Discussion 

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

100% of the aPAD or cPAD, respectively. The following paragraphs are summaries of the 

DEEM-FCID (ver. 3.16) acute and chronic exposure analyses. 

Acute and chronic aggregate (food+ water) analyses were performed using DEEM-FCID 

estimating the dietary exposure of the U.S. population and various population subgroups. The 

results are summarized in Tables 4 and 5 below for acute and chronic analyses respectively. 

The resulting acute food exposure estimates were less than HED's level of concern (<100% 

aPAD) at the 95111 percentile of the exposure distribution for general US population ( 15 % aPAD) 

and all population sub-groups; the most highly exposed population subgroup was All lnfants < l 

year old with 49 % aPAD. The resulting chronic food exposure estimates were less than HED's 

leve l of concern (< I 00% cPAD) for the general U.S. population (26 % cPAD) and all population 

sub-groups; the most highly exposed population subgroup was children 1-2 years old with 89 % 

cPAD. A separate cancer dietary assessment was not conducted for difenoconazole because the 

cancer NOAEL is higher than the chronic RID; therefore, the chronic dietary risk estimate is 

considered protective of all chronic effects including carcinogenicity. 

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Table 4. Summary of Acute Dietary (Food p lus Water) Exposu re and Risk for Difenoconazole at the 95th 

Percentile. 

Population Subgroup aPAD (mg/kg/day) Exposure {mg/kg/day) % aPAD 

General U.S. Population 0.038371 15 

All Infants(< I year old) 0.122946 49 

Children 1-2 years old 0. 108065 43 

Children 3-5 years old 0.074 134 30 

0.25 

Children 6-12 years old 0.050183 20 

Youth 13-19 years old 0.024840 10 

Adults 20-49 years old 0.026003 10 

Adults 50-99 years old 0.028849 12 

Females 13-49 years old 0.025932 10 

The bolded %aPAD is the highest. 

Table 5. Summary of Chronic Dietary (Food plus Water) Exposur e and Risk for Difenoconazole. 

Population Subgrou p cPAD (mg/kg/day) Exposu re {mg/kg/day) %cPAD 

General U.S. Population 0.00259 1 26 

All In fa nts(< 1 year old) 0.00769 1 77 

Children 1-2 years old 0.008894 89 

Children 3-5 years old 0.006043 60 

0.01 

Children 6-1 2 years old 0.003709 37 

Youth 13-1 9 years old 0.002016 20 

Adults 20-49 years old 0.001893 19 

Adults 50-99 years old 0.002095 2 1 

Females 13-49 years old 0.001856 19 

The bolded 'YocPAD is the highest. 

VIII. Characterization of Inputs/Outputs 

The acute analysis assumed tolerance-level residues, 100% CT, and empirical or DEEM default 

processing factors. The chronic analysis assumed tolerance-level residues for some 

commodities, average field trial residues and USDA PDP monitoring data for the remaining 

commodities, average% CT, and empirical or DEEM default processing factors. Therefore, 

these analyses are considered refined. While they could be further refined, further refinement is 

not warranted as estimated risks are not of concern. 

12of29 
Difenoconazole 

PC Code: 128847 

IX. Conclusions 

Dietary Exposure Assessment DP#: 426491 

An acute aggregate (food + water) dietary risk assessment was conducted for difenoconazole 

using the DEEM-FCID Model and assumed tolerance-level residues, 100% CT, and empirical or 

DEEM default processing factors. The chronic aggregate dietary risk assessment assumed 

tolerance-level residues for some commodities, average field trial residues and USDA PDP 

mo nitoring data for the remaining commodities, average% CT, and empirical or DEEM default 

processing factors. The resulting acute and chronic aggregate exposure estimates were less than 

HED's level of concern. For the general U.S. population, the aPAD and cPAD were 15 % and 

26 %, respectively. The most highly-exposed population subgroup in the acute (at the 951h 

percentile of the exposure distribution) was All Infants <l year old ( 49 % aP AD) and chronic 

analysis were children 1-2 years old (89 % cPAO), respective ly. 

X. List of Attachments 

Attachment I: DEEM-FCIOTM Acute Residue File 

At1achment 2: DEEM-FCrDTM Acute Exposure Estimates 

Attachment 3: DEEM-FCIDTM Chronic Residue File 

Attachment 4: DEEM-FCIDTM Chronic Exposure Estimates 

Attachment 5: Percent Crop Treated Memorandum 

cc with all attachments: T. Morton (RABIV) 

ROI: N. Dodd and I. Encarnacion - DESAC (I 2-March-2015); C. Smith ( l-July-2015) 

Petition Number(s): 4E8274 

PC Code: 128847 

T. Morton:S I 0838:PY I :(703)305-6691 

13 of29 
Di fenoconazole 

PC Code: 128847 

Dietary Exposure Assessment 

Attachment 1: DEEM-FCID Acute Residue File 

DP#: 426491 

Filename: C:\Users\tmorton\Documents\My Files\DEEM Files\128847 Difenoconazole\128847 

Difenoconazole 4E8274 Mar 201S\128847 Acute Ma r 201S Food and Water.ROS 

Chemical : Difenoconazole 

RfD(Chronic) : .01 mg/kg bw/day NOEL(Chronic): O mg/kg bw/day 

RfD(Acute) : .2S mg/kg bw/day NOEL(Acute): O mg/kg bw/day 

Date created/last modified: 03-06-201S/07:02:16 Program ver. 3.16, 03-08-d 

EPA Crop 

Code Grp Commodity Name 

01010S2000 lA 

01010S2001 lA 

01010S3000 lA 

01010S3001 lA 

0101078000 lAB 

0101078001 lAB 

0101079000 lAB 

0101168000 lAB 

010301SOOO lCD 

010301S001 lCD 

0103017000 lCD 

0103082000 lCD 

0103082001 lCD 

010313 9000 lCD 

0103166000 lCD 

010316 6001 lCD 

0103167000 lCD 

0103296000 lC 

0103297000 lC 

0103297001 lC 

0103298000 lC 

0103298001 lC 

0103299000 lC 

0103299001 lC 

0103300000 lC 

0103 300001 lC 

0103366000 lCD 

0103366001 lCD 

0103371000 lCD 

01 03387000 lCD 

0103406000 lCD 

0103407000 lCD 

030116SOOO 3A 

030116S00 1 3A 

0301237000 3A 

0301237001 3A 

0301238000 3A 

0301238001 3A 

0301338000 3A 

0302103000 3B 

0302198000 3B 

0302239000 3B 

0302338SOO 3B 

OS0 1061000 SA 

OS0106100 1 SA 

OS01062000 SA 

OS01064000 SA 

OS01069000 SA 

OS0107 1000 SA 

OS01072000 SA 

0501083000 SA 

05011960 00 SA 

OS02063000 SB 

OS02070000 SB 

OS02117000 SB 

OS02194000 SB 

OS02229000 SB 

OS02318000 SB 

OS0 2389000 SB 

06003 47000 6 

0600349000 6 

0600349001 6 

0600350000 6 

06003S0001 6 

0601349S00 6AB 

Beet, sugar 

Beet, sugar-babyfood 

Beet, sugar, molasses 

Beet, sugar, molasses-babyfood 

Carrot 

Carrot- babyfood 

Carrot, juice 

Ginseng, dried 

Arrowroot, flour 

Arrowroot, flour-babyfood 

Artichoke, Jerusalem 

Cassava 

Cassava-babyfood 

Dasheen, corm 

Ginger 

Ginger-babyfood 

Ginger, dried 

Potato, chips 

Potato, dry (granules/ flakes) 

Potato, dry (granules/ flakes)-b 

Potato, flour 

Potato, flour-babyfood 

Potato, tuber, w/peel 

Potato, tuber, w/ peel-babyfood 

Potato, tuber, w/o peel 

Potato, tuber, w/o peel-babyfood 

Sweet potato 

Sweet potato-babyfood 

Tanier, corm 

Turmeric 

Yam, true 

Yam bean 

Garlic, bulb 

Garlic, bulb-babyfood 

Onion, bulb 

Onion, bulb- babyfood 

Onion, bulb, dried 

Onion, bulb, dried-babyfood 

Shallot, bulb 

Chive, fresh leaves 

Leek 

Onion, green 

Shallot, fresh leaves 

Broccoli 

Broccoli-baby food 

Broccoli, Chinese 

Brussels sprouts 

cabbage 

Cabbage, Chinese , napa 

Cabbage, Chinese , mustard 

Cauliflower 

Kohlrabi 

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 

Soybean, vegetable 

Def Res 

(ppm) 

0.300000 

0.300000 

0.300000 

0.300000 

0.500000 

o.sooooo 

0.500000 

1.000000 

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 

4.000000 

4.000000 

4.000000 

4.000000 

4.000000 

4.000000 

4.000000 

4.000000 

0 .200000 

0.200000 

0.200000 

0.200000 

0.200000 

0 .200000 

0.200000 

6.000000 

6.000000 

6.000000 

6.000000 

1.900000 

1.900000 

1.900000 

1. 900000 

1.900000 

1.900000 

1 . 900000 

1.900000 

1.900000 

3S.OOOOOO 

3S.OOOOOO 

3S . 000000 

3S.OOOOOO 

35.000000 

)S.000000 

3S.OOOOOO 

O.lSOOOO 

0.150000 

0 .150000 

0.150000 

0.150000 

0.150000 

14 of29 

Adj.Factors 

#1 #2 

1.000 

1. 000 

0 . 600 

0 . 600 

1 . 000 

1.000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

1.000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

o.soo 

0 . 500 

0 . 500 

o.soo 

0.500 

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 

9 . 000 

9.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1. 000 

1. 000 

1. 000 

1.000 

1. 000 

1 . 000 

1.000 

1. 000 

1.000 

1. 000 

1.000 

1. 000 

1 . 000 

1.000 

1 . 000 

1. 000 

1. 000 

1. 000 

1.000 

1 . 000 

1.000 

1.000 

1. 000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1. 000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1. 000 

1.000 

1. 000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1. 000 

1. 000 

1.000 

1.000 

Comment 
Difenoconazole Dietary Exposure Assessment DPll: 426491 

PC Code: 128847 

0603030000 6C Bean, black, seed 0.200000 l.000 1.000 

0603032000 6C Bean, broad, seed 0.200000 1. 000 l. 000 

0603034000 6C Bean, cowpea, seed 0.200000 1.000 l. 000 

0603035000 6C Bean, great northern, seed 0 . 200000 1. 000 l. 000 

0603036000 6C Bean, kidney, seed 0 . 200000 1.000 l.000 

060303SOOO 6C Bean, lima, seed 0.200000 1. 000 1 .000 

0603039000 6C Bean , mung, seed 0 .200000 1 . 000 1 .000 

0603040000 6C Bean, navy , seed 0 . 200000 1. 000 1 . 00 0 

0603041000 6C Bean, pink, seed 0.200000 l. 000 l. 000 

0603042000 6C Bean, pinto, seed 0.200000 l. 000 l . 000 

060309SOOO 6C Chickpea. seed 0.200000 1. 000 l.000 

060309SOOl 6C Chickpea, seed-baby food 0 . 200000 l. 000 l .000 

0603099000 6C Chickpea, flour 0 . 200000 l . 000 l. 000 

06031S2000 6C Guar. seed 0.200000 l. 000 1.000 

06031S2001 6C Guar. seed-baby food 0.200000 l. 000 1.000 

0603203000 6C Lentil, seed 0.200000 l. 000 1.000 

0603256000 6C Pea, dry 0.200000 l . 000 1.000 

0603256001 6C Pea, dry-babyfood 0.200000 1. 000 l. 000 

060325SOOO 6C Pea, pigeon, seed 0.200000 l. 000 1.000 

060334SOOO 6C Soybean, flour 0 . 150000 l. 000 l. 000 

060334S001 6C Soybean, flour-babyfood 0.150000 1. 000 l. 000 

OS01374000 SA Tomatillo 0 .600000 1. 000 l. 000 

OS01375000 SA Tomato 0.600000 1. 000 1. 000 

OS01375001 SA Tomato-babyfood 0 . 600000 l. 000 l. 000 

OS01376000 SA Tomato, paste 0.600000 1 . 600 l. 000 

OS01376001 SA Tomato, paste-babyfood 0 . 600000 1. 600 1.000 

OS01377000 SA Tomato , puree 0 . 600000 0.500 l .000 

OS01377001 SA Tomato, puree-babyfood 0 .600000 0.500 1 .000 

OS0137SOOO SA Tomato, drie d 0 . 600000 14. 300 l. 000 

OS0137S001 SA Tomato, dried-babyfood 0.600000 14.300 1.000 

OS01379000 SA Tomato, juice 0.600000 l. 500 1.000 

OS013SOOOO SA Tomato, Tree 0.600000 1.000 1 . 000 

OS0214SOOO SBC Eggplant 0 . 600000 1. 000 l. 000 

OS02234000 SBC Okra 0 .600000 1. 000 1 .000 

OS02270000 SB Pepper , bell 0 . 600000 1.000 1 .000 

OS0227000 1 SB Pepper, be 11-baby food 0.600000 1.000 1 .000 

OS02271000 SB Peppe r, bell , dried 0.600000 1.000 l. 000 

OS02271001 SB Pepper, bell, dried-baby food 0.600000 1.000 l. 000 

OS02272000 SBC Pepper, nonbell 0 . 600000 l. 000 1.000 

OS02272001 SBC Pepper, nonbell-babyfood 0.600000 1.000 1.000 

OS02273000 SBC Pepper, nonbell, dried 0.600000 1. 000 1.000 

0901075000 9A Cantaloupe 0.700000 1.000 l. 000 

09011S7000 9A Honeydew melon 0.700000 1. 000 l. 000 

0901399000 9A watermelon 0.700000 l. 000 l. 000 

0901400000 9A watermelon, juice 0.700000 l. 000 1.000 

0902021000 9B Balsam pear 0 . 700000 l. 000 1 . 000 

0902088000 9B Chayote, fruit 0.700000 1.000 1. 000 

0902102000 9B Chinese waxgourd 0.700000 1. 000 1. 000 

0902135000 9B Cucumber 0 . 700000 1. 000 1 . 000 

0902308000 9B Pumpkin 0.700000 l. 000 1.000 

0902309000 9B Pumpkin, seed 0 . 700000 1 . 000 1 . 000 

0902356000 9B squash, summer 0.700000 1. 000 1.000 

0902356001 9B Squash, summer-babyfood 0.700000 1 . 000 1.000 

0902357000 9B Squash, winter 0.700000 l. 000 1 . 000 

0902357001 9B squash, winter- babyfood 0 . 700000 1.000 1.000 

1001106000 lOA Citron 0.600000 1.000 1 . 000 

1 001107000 lOA Citrus hybrids 0 . 600000 1. 000 1.000 

lOOllOSOOO lOA Citrus, oil 25.000000 1. 000 1 .000 

1001240000 lOA Orange 0.600000 1. 000 1.000 

1001241000 lOA orange, juice 0 . 600000 0.100 1.000 

1001241001 lOA orange, juice-babyfood 0.600000 0.100 1.000 

1001242000 lOA Orange, peel 0.600000 1.000 1.000 

1001369000 lOA Tangerine 0.600000 l. 000 1.000 

1001370000 l OA Tangerine, j u ice 0 . 600000 0 . 100 1.000 

1002197000 lOB Kumquat 0 .600000 1. 000 1. 000 

1002199000 lOB Lemon 0.600000 1.000 1. 000 

1002200000 lOB Lemon, juice 0.600000 0.100 1.000 

1002200001 lOB Lemon, juice-babyfood 0.600000 0.100 1.000 

1002201000 lOB Lemon, peel 0.600000 1.000 1. 000 

1002206000 lOB Lime 0.600000 1. 000 1 .000 

1002207000 l OB Lime . juice 0.600000 0.100 1. 000 

1002207001 108 Lime, juice- babyfood 0.600000 0 .100 l .000 

10031SOOOO lOC Grapefruit 0.600000 1. 000 1. 000 

10031Sl000 lOC Grapefruit, juice 0.600000 0.100 1. 000 

1003307000 lOC Pummelo 0.600000 1.000 1.000 

1100007000 11 Apple, fruit with peel 5.000000 l. 000 1 . 000 

llOOOOSOOO 11 Apple, peeled fruit 5.000000 l.000 1.000 

1100008001 11 Apple , p ee l ed fruit-babyfood 5 . 000000 1.000 1 . 000 

15 of29 
Difenoconazole Dietary Exposure Assessment DP#: 426491 

PC Code: 128847 

1100009000 11 Apple, dried 5.000000 8.000 1.000 

1100009001 11 Apple, dried-babyfood 5.000000 8.000 1. 000 

1100010000 11 Apple, juice 5.000000 0.040 1. 000 

1100010001 11 Apple, juice-babyfood 5.000000 0.040 1. 000 

1100011000 11 Apple, sauce 5.000000 1.000 1.000 

1100011001 11 Apple, sauce-babyfood 5.000000 1.000 1.000 

1100129000 11 Crabapple 5.000000 1.000 1.000 

1100173500 11 Goji berry 5.000000 1.000 1.000 

1100210000 11 Loquat 5.000000 1.000 1.000 

1100266000 11 Pear 5.000000 1.000 1 . 000 

1100266001 11 Pear-babyfood 5.000000 1.000 1.000 

1100267000 11 Pear, dried 5.000000 6.250 1.000 

1100268000 11 Pear, juice 5.000000 1.000 1.000 

1100268001 11 Pear, juice-babyfood 5.000000 1.000 1.000 

1100310000 11 Quince 5.000000 1. 000 1.000 

1201090000 12A Cherry 2.500000 1. 000 1.000 

1201090001 12A Cherry-babyfood 2.500000 1. 000 1. 000 

1201091000 12A Cherry, juice 2.500000 1. 500 1. 000 

1201091001 12A Cherry, juice-babyfood 2.500000 1.500 1. 000 

1202012000 12B Apricot 2.500000 1. 000 1. 000 

1202012001 12B Apricot-baby food 2.500000 1. 000 1. 000 

1202013000 126 Apricot, dried 2.500000 6.000 1. 000 

1202014000 12B Apricot, juice 2.500000 1. 000 1. 000 

1202014001 12B Apricot, juice-babyfood 2.500000 1. 000 1.000 

1202230000 126 Nectarine 2.500000 1. 000 1.000 

1202260000 126 Peach 2.500000 1. 000 1.000 

1202260001 126 Peach-babyfood 2.500000 1 .000 1.000 

1202261000 12B Peach, dried 2.500000 7.000 1. 000 

1202261001 126 Peach, dried-babyfood 2.500000 7.000 1.000 

1202262000 12B Peach, juice 2.500000 1.000 1.000 

1202262001 12B Peach, juice-babyfood 2.500000 1.000 1. 000 

1203285000 12C Plum 2.500000 1.000 1.000 

1203285001 12C Plum-babyfood 2.500000 1.000 1.000 

1203286000 12C Plum, prune, fresh 2.500000 1.000 1.000 

1203286001 12C Plum, prune, fresh-babyfood 2.500000 1.000 1.000 

1203287000 12C Plum, prune, dried 2.500000 5.000 1. 000 

1203287001 12C Plum, prune , dried- baby food 2.500000 5.000 1.000 

1203288000 12C Plum, prune, juice 2.500000 1.400 1. 000 

1203288001 12C Plum, prune, juice-babyfood 2.500000 1 . 400 1.000 

1302057000 13B Blueberry 4.000000 1. 000 1. 000 

1302057001 13B Blueberry-babyfood 4.000000 1.000 1.000 

1302136000 13B currant 4.000000 1. 000 1. 000 

1302137000 13B Currant, dried 4.000000 1. 000 1. 000 

1302149000 13B Elderberry 4.000000 1. 000 1. 000 

1302174000 13B Gooseberry 4.000000 1. 000 1.000 

1302191000 13B Huckleberry 4.000000 1. 000 1. 000 

13 041 75000 130 Grape 4.000000 1. 000 1. 000 

1304176000 130 Grape, juice 4.000000 0.200 1. 000 

1304176001 130 Grape, juice-babyfood 4.000000 0.200 1. 000 

1304179000 130 Grape, wine and s herry 4.000000 1. 000 1. 000 

1307130000 13G Cranberry 4.000000 1. 000 1. 000 

1307130001 13G Cranberry-baby food 4.000000 1. 000 1.000 

1307131000 13G Cranberry, dried 4.000000 1. 000 1.000 

1307132000 13G Cranberry, juice 4.000000 1.100 1. 000 

1307132001 13G Cranberry, juice-babyfood 4.000000 1.100 1.000 

1307359000 13G Strawberry 2.500000 1.000 1.000 

1307359001 13G Strawberry-babyfood 2.500000 1. 000 1.000 

1307360000 13G Strawberry, juice 2.500000 1. 000 1.000 

1307360001 13G Strawberry, juice-babyfood 2.500000 1.000 1.000 

1400003000 14 Almond 0.030000 1.000 1.000 

1400003001 14 Almond-baby food 0.030000 1.000 1.000 

14 00004 000 14 Almond, oil 0.030000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.030000 1.000 1.000 

1400059000 14 Brazil nut 0.030000 1.000 1.000 

1400068000 14 Butternut 0.030000 1. 000 1.000 

1400081000 14 Cashew 0.030000 1.000 1.000 

14 00092000 14 Chestnut 0.030000 1.000 1. 000 

1400155000 14 Hazelnut 0.030000 1. 000 1. 000 

1400156000 14 Hazelnut, oil 0.030000 1. 000 1. 000 

1400185000 14 Hickory nut 0 . 030000 1.000 1. 000 

1400213000 14 Macadamia nut 0 . 030000 1. 000 1. 000 

1400269000 14 Pecan 0.030000 1. 000 1. 000 

1400278000 14 Pine nut 0 .030000 1. 000 1.000 

14 00282000 14 Pistachio 0.030000 1. 000 1.000 

1400391000 14 walnut 0.030000 1. 000 1. 000 

1500025000 15 Barley, pearled barley 0.100000 1.000 1. 000 

1500025001 15 Barley, pearled barley- baby food 0.100000 1. 000 1. 000 

1500026000 15 Barley, flour 0.100000 1. 000 1. 000 

16 of29 
Di fenoconazole Dietary Exposure Assessment OP#: 42649 1 

PC Code: 128847 

1500026001 15 Barley, flour- baby food 0.100000 1. 000 1. 000 

1500027000 15 Barley, bran 0.100000 1. 000 1. 000 

1500127000 15 Corn, sweet 0 . 01 0000 1. 000 1 . 000 

1500127001 15 Corn, sweet-babyfood 0.010000 1.000 1. 000 

1500231000 15 Oat, bran 0.010000 1.000 1. 000 

1500232000 15 Oat, flour 0.010000 1. 000 1.000 

1500232001 15 Oat, flour-babyfood 0.010000 1.000 1.000 

1500233000 15 Oat, groats/rolled oats 0.010000 1. 000 1.000 

1500233001 15 Oat, groats/rolled oats-babyfood 0.010000 1. 000 1.000 

1500328000 15 Rye, grain 0.010000 1. 000 1. 000 

1500329000 15 Rye, flour 0.010000 1.000 1.000 

1500381000 15 Triticale, flour 0.100000 1.000 1.000 

1500381001 15 Triticale, flour-baby food 0.100000 1. 000 1.000 

1500401000 15 wheat, grain 0.100000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 0.100000 1.000 1. 000 

1500402000 15 Wheat, flour 0.100000 l.000 1. 000 

1500402001 15 Wheat, flour-baby food 0.100000 1.000 1. 000 

1500403000 15 Wheat, germ 0.100000 1. 000 1.000 

1500404000 15 Wheat, bran 0.100000 1. 000 1.000 

2001163000 20A Flax seed, oil 0.100000 l.000 1. 000 

2001319000 20A Rapeseed, oil 0.100000 1. 000 1. 000 

2001319001 20A Rapeseed, oil-babyfood 0.100000 l. 000 1. 000 

2001336000 20A Sesame, seed 0.100000 l. 000 1. 000 

2001336001 20A Sesame, seed-baby food 0.100000 1.000 1. 000 

2001337000 20A Sesame, oil 0.100000 1. 000 1. 000 

2001337001 20A Sesame, oil-babyfood 0.100000 1. 000 1.000 

2003128000 20C Cottonseed, oil 0.050000 1.000 1. 000 

2003128001 20C Cottonseed, oil-babyfood 0.050000 1. 000 1 . 000 

3100044000 31 Beef, meat 0.050000 1.000 1.000 

3100044001 31 Beef, meat- babyfood 0.050000 1. 000 l. 000 

3100045000 31 Beef, meat, dried 0.050000 l. 920 1. 000 

3100046000 31 Beef. meat byproducts 0.100000 l. 000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.100000 1. 000 1.000 

3100047000 31 Beef. fat 0.100000 l.000 l. 000 

3100047001 31 Beef. fat-babyfood 0.100000 1. 000 1 . 000 

3100048000 31 Beef, kidney 0.100000 1. 000 1.000 

3100049000 31 Beef, liver 0.400000 1. 000 1.000 

3100049001 31 Beef. liver-babyfood 0.400000 1.000 1.000 

3200169000 32 Goat, meat 0.050000 1. 000 1.000 

3200170000 32 Goat, meat byproducts 0.100000 1.000 1.000 

3200171000 32 Goat, fat 0.100000 1. 000 1.000 

3200172000 32 Goat, kidney 0.100000 1. 000 1. 000 

3200173000 32 Goat, liver 0.400000 l. 000 1.000 

3300189000 33 Horse, meat 0.050000 l. 000 l. 000 

3400290000 34 Pork, meat 0.050000 1.000 1.000 

3400290001 34 Pork, meat- babyfood 0.050000 1. 000 1 . 000 

3400291000 34 Pork, skin 0.100000 l. 000 1.000 

3400292000 34 Pork, meat byproducts 0.100000 1. 000 1.000 

3400292001 34 Pork. meat byproducts-babyfood 0.100000 1.000 1 . 000 

3400293000 34 Pork, fat 0.100000 1. 000 1.000 

3400293001 34 Pork, fat-babyfood 0.100000 l. 000 1.000 

34 00294 000 34 Pork, kidney 0.100000 l. 000 1. 000 

3400295000 34 Pork. liver 0. 400000 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 0.100000 1.000 l. 000 

3500341000 35 Sheep, fat 0.100000 1. 000 1.000 

3500341001 35 Sheep, fat - baby food 0.100000 1.000 1.000 

3500342000 35 Sheep, kidney 0.100000 1.000 1. 000 

3500343000 35 Sheep, liver 0. 400000 1.000 1. 000 

3600222000 36 Milk, fat 0.020000 1. 000 1.000 

3600222001 36 Milk, fat-baby food / infant formu 0.020000 1.000 1. 000 

3600223000 36 Milk, nonfat solids 0.020000 1. 000 1.000 

3600223001 36 Milk, nonfat solids-baby food/in 0.020000 1. 000 1.000 

3600224000 36 Milk, water 0.020000 1. 000 1.000 

3600224001 36 Milk, water-babyfood/infant form 0.020000 1. 000 l. 000 

3600225001 36 Milk, sugar (lactose)-baby food/ 0.020000 1. 000 1.000 

7000145000 70 Egg, whole 0.020000 1. 000 l. 000 

7000145001 70 Egg, whole-babyfood 0.020000 1.000 1.000 

7000146000 70 Egg, white 0.020000 1.000 1.000 

7000146001 70 Egg, white (solidsJ- babyfood 0.020000 1.000 1.000 

7000147000 70 Egg, yolk 0.020000 l. 000 1.000 

7000147001 70 Egg, yolk-babyfood 0.020000 1.000 1. 000 

8601000000 86A Water, direct, all sources 0.020000 1. 000 1. 000 

8602000000 86B Water, indirect, all sources 0.020000 1. 000 1.000 

9500016000 0 Artichoke, globe 1.500000 1. 000 1.000 

9500023000 0 Banana 0.200000 l. 000 1. 000 

9500023001 0 Banana-babyfood 0.200000 l. 000 1. 000 

17 of 29 
Di fcnoconazole Dietary Exposure Assessment DP#: 426491 

PC Code: 128847 

9500024000 0 Banana, dried 0.200000 3.900 1.000 

9500024001 0 Banana, dried-babyfood 0.200000 3.900 1.000 

9500177000 0 Grape, leaves 4.000000 1.000 1.000 

9500178000 0 Grape, raisin 6.000000 1.000 1.000 

9500215000 0 Mango 0 . 070000 1.000 1.000 

9500215001 0 Mango-babyfood 0 . 070000 1.000 1. 000 

9500216000 0 Mango, dried 0.070000 1.000 1. 000 

9500217000 0 Mango, juice 0.070000 1.000 1 . 000 

9500217001 0 Mango. juice-babyfood 0 . 070000 1.000 1. 000 

9500245000 0 Papaya 0.300000 1. 000 1. 000 

950024 5001 0 Papaya-babyfood 0.300000 1.000 1. 000 

9500246000 0 Papaya, dried 0.300000 1. 800 1. 000 

9500247000 0 Papaya, juice 0.300000 1.500 1. 000 

9500283000 0 Plantain 0 . 200000 1. 000 1.000 

9500284000 0 Plantain, dried 0.200000 3 .900 1.000 

18 of 29 
Difenoconazole 

PC Code: 128847 

Dietary Exposure Assessment DP#: 42649 1 

Attachment 2: DEEM-FCID Acute Exposure Estimates 

US EPA 

OEEM-FCIO ACUTE Analysis for OIFENOCONAZOLE 

ver. 3 . 18, 03-08-d 

NHANES 2003-2008 2-Day 

Residue file: 128847 Acute Mar 2015 Food and Water.ROS 

Adjustment factor #2 used. 

Analysis Date: 04-14-2015/07:17:06 

RAC/FF intake summed over 24 hours 

Run Comment: "" 

Summary calculations--per capita: 

95th Percentile 

Exposure \ aRfD 

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

0.038371 15. 35 

All Infants: 

0.122946 49. 18 

Children 1-2: 

0.108065 43 . 23 

Children 3-5: 

0.074134 29.65 

Children 6-12 : 

0 .050183 20.07 

Youth 13-19: 

0.024840 9. 94 

Adults 20-49: 

0 . 026003 10 .40 

Adults 50-99: 

0.028849 11. 54 

Female 13-49: 

0.025932 10. 37 

FOOD ONLY 

US EPA 

Residue file dated : 04-14-2015/07:12:29 

99th Percentile 99.9th Percentile 

Exposure ' aRfD Exposure ' aRfD 

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

0.080320 32.13 0.159182 63.67 

0.188019 75.21 0 .266271 106 . 51 

0.167396 66 .96 0.40744 1 162 .98 

0 .120179 48 . 07 0.230086 92 . 03 

0.084207 33.68 0 .145216 58.09 

0.043253 17. 30 0.121941 48.78 

0.044454 17.78 0.102906 41.16 

0.058188 23 . 28 0.127083 50.83 

0.044352 17.74 0.102615 41. 05 

DEEM-FCID ACUTE Analysis for DIFENOCONAZOLE 

Residue file: 128847 Acute Mar 2015 Food Only.ROB 

Ver. 3.18, 03-08-d 

NHANES 2003-2008 2-Day 

Adjustment factor #2 used. 

Analysis Date: 04-14-2015/07:41:27 Residue file dated: 04-14-2015/07:11:38 

RAC/FF intake summed over 24 hours 

Run Comment: "" 

Summary calculations--per capita: 

95th Percentile 99th Percentile 99.9th Percentile 

Exposure ' aRfD Exposure ' aRfD Exposure ' aRfD 

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

0.037864 15.15 0.079985 31. 99 0.158254 63 . 30 

All Infants: 

0.121522 48.61 0 .185721 74 . 29 0.265664 106 . 27 

Children 1-2: 

0.107552 43 .02 0.166250 66 . 50 0. 404915 161.97 

Children 3 - 5: 

0 . 073611 29 . 44 0. 118936 47.57 0.228458 91. 3 8 

Children 6-12: 

0. 049833 19.93 0.083 109 33.24 0.145147 58 . 06 

Youth 13-19: 

0. 024462 9.78 0.042645 17.06 0.121769 48. 71 

Adults 20-49: 

0.0253 81 10.15 0.043966 17.59 0 . 102720 41. 09 

Adults 50-99: 

0.028263 11. 31 0 .057725 23 .09 0 .126771 50 . 71 

Female 13 -4 9: 

0.025437 10.17 0.043864 17.55 0.102467 40 . 99 

19 of29 
Difenoconazole 

PC Code: 12884 7 

Dietary Exposure Assessment 

Attachment 3: DEEM-FCID Chronic Residue File 

DP#: 426491 

Filename: C:\Users\tmorton\Documents\ My Files\DEEM Files\128847 Difenoconazole\128847 

Difenoconazole 4£8274 Mar 2015\12884 7Chronic Mar 2015 Food and water.ROS 

Chemical: Difenoconazole 

RfD{Chronic) : .01 mg/kg bw/day NOEL(Chronic): O mg/kg bw/day 

RfD(Acute): .25 mg/kg bw/day NOEL(Acute): O mg/kg bw/day 

Date created/last modified: 04-l4-201S/06:Sl:34 Program ver. 3.16, 03-08-d 

EPA Crop 

Code Grp Commodity Name 

Def Res 

(ppm) 

01010S2000 lA 

01010S2001 lA 

01010S3000 lA 

01010S3001 lA 

0101078000 lAB 

0101078001 lAB 

0101079000 lAB 

0101168000 lAB 

010301SOOO lCD 

010301S001 lCD 

0103017000 lCD 

0103082000 lCD 

0103082001 lCD 

0103139000 lCD 

0103166000 lCD 

0103166001 .lCD 

0103167000 lCD 

0103296000 lC 

0103297000 lC 

0103297001 lC 

0103298000 lC 

0103298001 lC 

0103299000 lC 

0103299001 lC 

0103300000 lC 

0103300001 lC 

0103366000 lCD 

0103366001 lCD 

0103371000 lCD 

0103387000 lCD 

0103406000 lCD 

0103407000 lCD 

030116SOOO 3A 

030116S001 3A 

0301237000 3A 

0301237001 3A 

0301238000 3A 

0301238001 3A 

0301338000 3A 

0302103000 3B 

0302198000 3B 

0302239000 3B 

0302338SOO 3B 

OS01061000 SA 

OS01061001 SA 

OS01062000 SA 

OS01064000 SA 

OS01069000 SA 

OS01071000 SA 

OS01072000 SA 

0S01083000 SA 

0S01196000 SA 

OS02063000 SB 

OS02070000 SB 

OS02117000 SB 

OS02194000 SB 

OS02229000 SB 

OS02318000 SB 

OS02389000 SB 

06003 47000 6 

0600349000 6 

06003 49001 6 

06003SOOOO 6 

06003S0001 6 

0601349SOO 6AB 

Beet, sugar 

Beet, sugar-babyfood 

Beet, sugar, molasses 

Beet. sugar, molasses-babyfood 

Carrot 

Carrot- babyfood 

Carrot. juice 

Ginseng, dried 

Arrowroot. flour 

Arrowroot, flour-babyfood 

Artichoke, Jerusalem 

cassava 

Cassava-babyfood 

Dasheen, corm 

Ginger 

Ginger- baby food 

Ginger, dried 

Potato, chips 

Potato, dry (granules/ flakes) 

Potato, dry (granul es/ flakes) - b 

Potato, flour 

Potato, flour-babyfood 

Potato. tuber, w/peel 

Potato. tuber, w/ peel- babyfood 

Potato, tuber. w/o peel 

Potato, tuber. w/o peel - babyfood 

Sweet potato 

Sweet potato-babyfood 

Tanier, corm 

Turmeric 

Yam, true 

Yam bean 

Garlic, bulb 

Garlic, bulb-babyfood 

Onion, bulb 

Onion, bulb-babyfood 

Onion, bulb. dried 

Onion, bulb, dried-babyfood 

Shallot. bulb 

Chive. fresh leaves 

Leek 

Onion, green 

Shallot, fresh leaves 

Broccoli 

Broccoli-babyfood 

Broccoli, Chinese 

Brussels sprouts 

Cabbage 

Cabbage. Chinese. napa 

Cabbage, Chinese. mustard 

Cauliflower 

Kohlrabi 

Broccoli raab 

Cabbage. Chinese, bok choy 

Collards 

Kale 

Mustard greens 

Rape greens 

Turnip, greens 

soybean, seed 

Soybean, soy milk 

Soybean, soy milk-babyfood or i n 

Soybean, oil 

Soybean, oil-babyfood 

Soybean, vegetable 

0.300000 

0. 300000 

0.300000 

0.300000 

0.007000 

0.007000 

0.007000 

0.316000 

1.360000 

1.360000 

1.360000 

1.360000 

1 .360000 

1 .360000 

1.360000 

1. 360000 

1. 3 60000 

1.360000 

1. 360000 

l.360000 

1.360000 

1.360000 

1.360000 

1.360000 

1.360000 

1.360000 

1.360000 

1.360000 

1.360000 

1 . 360000 

1 .360000 

1.360000 

0.002SOO 

0.002SOO 

0.002SOO 

0.002SOO 

0.002SOO 

0.002SOO 

0.002S00 

6.000000 

6.000000 

6.000000 

6.000000 

0.019000 

0.019000 

0.019000 

0.029000 

0.029000 

0.029000 

0.003000 

0.003000 

0.029000 

5.100000 

5.100000 

S.100000 

S .100000 

S.100000 

5.100000 

S.100000 

0.021SOO 

0.021SOO 

0.021SOO 

0.021SOO 

0.021SOO 

0.021500 

20 of 29 

Adj.Factors 

#1 112 

1.000 

1.000 

0.600 

0.600 

1. 000 

1. 000 

1. 000 

1 . 000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

o.soo 

o.soo 

o.soo 

0.500 

o.soo 

1 . 000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

9 . 000 

9 . 000 

1. 000 

1. 000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1. 000 

1. 000 

1.000 

1 . 000 

1 . 000 

1.000 

1.000 

1.000 

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 . lSO 

O.lSO 

0.150 

0.150 

1. 000 

1. 000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1. 000 

1. 000 

1. 000 

1. 000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

o.oso 

o.oso 

o.oso 

o.oso 

0.050 

o.oso 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

0.025 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

Comment 
Difenoconazole Dietary Exposure Assessment DP#: 426491 

PC Code: 128847 

0603030000 6C Bean, black, seed 0.014000 1.000 l. 000 

0603032000 6C Bean, broad, seed 0 . 014000 1 . 000 1 . 000 

0603034000 6C Bean, cowpea, seed 0.014000 1.000 1. 000 

0603035000 6C Bean, great northern, seed 0. 014000 1.000 1.000 

0603036000 6C Bean, kidney, seed 0.014000 1.000 1. 000 

060303SOOO 6C Bean, lima, seed 0.014000 l. 000 1 .000 

0603039000 6C Bean , mung, seed 0.014000 l. 000 1. 000 

0603040000 6C Bean, navy, seed 0.014000 1.000 l. 000 

0603041000 6C Bean, pink, seed 0.014000 1.000 1. 000 

0603042000 6C Bean, pinto, seed 0. 014 000 1.000 l. 000 

060309SOOO 6C Chickpea, seed 0 . 014000 1.000 1 . 000 

060309S001 6C Chickpea, seed-babyfood 0 . 014000 1. 000 1. 000 

0603099000 6C Chickpea, flour 0.014000 1.000 1. 000 

06031S2000 6C Guar, seed 0.014000 1.000 1. 000 

06031S2001 6C Guar, seed-baby food 0.014000 1.000 l. 000 

0603203000 6C Lentil, seed 0 . 014000 1 . 000 1 . 000 

0603256000 6C Pea, dry 0.034000 1.000 1. 000 

0603256001 6C Pea, dry-baby food 0.034000 1.000 1. 000 

060325SOOO 6C Pea, pigeon, seed 0. 034000 1.000 l. 000 

060334SOOO 6C Soybean, flour 0 . 021500 1.000 l. 000 

060334S001 6C Soybean, flour-babyfood 0 . 021500 1. 000 l. 000 

OS01374000 SA Tomatillo 0.165000 1.000 1.000 

OS01375000 SA Tomato 0 . 165000 1.000 0 . 250 

OS01375001 SA Tomato-babyfood 0.165000 1. 000 0.250 

OS01376000 SA Tomato, paste 0.165000 1. 600 0 . 250 

OS01376001 SA Tomato, paste-babyfood 0. 1 65000 1 .600 0 . 250 

OS01377000 SA Tomato, puree 0 . 165000 0.500 0 . 250 

OS01377001 SA Tomato, puree-babyfood 0 . 165000 0.500 0.250 

OS0137SOOO SA Tomato, dried 0 . 165000 14. 300 0.250 

OS0137S001 SA Tomato, dried-baby food 0 . 165000 14. 300 0 . 250 

OS01379000 SA Tomato, jui ce 0 . 165000 1 . 500 0 . 250 

OS013SOOOO SA Tomato, Tree 0 . 165000 1.000 l. 000 

OS0214 sooo SBC Eggplant 0 .133000 1.000 1 . 000 

OS02234000 BBC Okra 0.600000 1.000 l. 000 

OS02270000 BB Pepper, bell 0 . 133000 1.000 0 . 025 

OS02270001 BB Pepper, be ll-babyfood 0 . 133000 1.000 0 . 025 

OS02271000 SB Pepper, bell, dried 0.133000 1.000 0.025 

OS02271001 SB Pepper, bell, dried-baby food 0.133000 1.000 0 . 025 

OS02272000 SBC Pepper, nonbell 0 . 133000 1.000 0 . 025 

OS02272001 SBC Pepper, nonbell-babyfood 0 . 133000 1.000 0 . 025 

OS02273000 SBC Pepper, nonbell, dried 0.133000 1.000 0 . 025 

0901075000 9A Cantaloupe 0.002500 l. 000 0.025 

09011S7000 9A Honeydew melon 0.002500 1.000 1 . 000 

0901399000 9A Watermelon 0.002500 1.000 0 . 050 

0901400000 9A Wa t ermelon, juice 0 . 002500 1. 000 0 . 050 

0902021000 9B Balsam pear 0.055000 1.000 l. 000 

09020SSOOO 9B Chayote, fruit 0.012000 l. 000 1.000 

0902102000 9B Chinese waxgourd 0 . 055000 1.000 1 . 000 

0902135000 9B cucumber 0.055000 l. 000 0 . 050 

090230SOOO 9B Pumpkin 0.012000 1 . 000 0.025 

0902309000 9B Pumpkin, seed 0.012000 1. 000 0.025 

0902356000 9B Squash, summer 0.012000 l. 000 0 . 050 

0902356001 9B Squash. summer-babyfood 0.012000 1 . 000 0 . 050 

0902357000 9B Squash, winter 0.012000 1. 000 0 . 050 

0902357001 9B Squash, wint er-baby food 0.012000 1. 000 0.050 

1001106000 lOA Citron 0.005000 1. 000 1. 000 

1001107000 lOA Citrus hybrids 0.005000 1.000 1. 000 

100110SOOO lOA Citrus, oil 25.000000 1. 000 1. 000 

1001240000 lOA Orange 0.005000 1. 000 0.025 

1001241000 lOA Orange, juice 0.005000 0.100 0 . 025 

1001241001 lOA Orange, juice-babyfood 0.005000 0.100 0 . 025 

1001242000 lOA Orange, peel 0.005000 1.000 0.025 

1001369000 lOA Tangerine 0.005000 1.000 0.025 

1001370000 lOA Tangerine, juice 0 . 005000 0 . 100 0 . 025 

1002197000 lOB Kumquat 0.005000 l. 000 1.000 

1002199000 lOB Lemon 0.005000 1.000 1.000 

1002200000 lOB Lemon, juice 0.005000 0.100 1.000 

1002200001 lOB Lemon, juice-baby food 0.005000 0 . 100 1 . 000 

1002201000 lOB Lemon, peel 0 . 005000 1.000 1. 000 

1002206000 lOB Lime 0.005000 1.000 1.000 

1002207000 lOB Lime, juice 0.005000 0.100 1 . 000 

1002207001 lOB Lime, juice-babyfood 0.005000 0.100 1.000 

10031SOOOO lOC Grapefruit 0 . 005000 1.000 0 . 025 

10031Sl000 lOC Grap efruit, juice 0.005000 0.100 0.025 

1003307000 lOC Pummelo 0.005000 1.000 1. 000 

1100007000 11 Apple, fruit with peel l. 4 20000 1.000 1. 000 

llOOOOSOOO 11 Apple, peeled fruit 1.420000 1.000 l. 000 

llOOOOSOOl 11 Apple, peele d fruit-babyfood 1. 420000 1. 000 1. 000 

21 of 29 
Di fenoconazole Dietary Exposure Assessment DP#: 426491 

PC Code: 128847 

1100009000 11 Apple, dried l.420000 8.000 1.000 

1100009001 11 Apple, dried-baby food 1. 420000 8.000 1.000 

1100010000 11 Apple, juice 1 . 420000 0 . 040 1.000 

1100010001 11 Apple, juice-babyfood l.420000 0.040 1.000 

1100011000 11 Apple, sauce 1. 420000 1 . 000 1.000 

1100011001 11 Apple, sauce-babyf ood 1.420000 1. 000 1.000 

1100129000 11 Crabapple 1. 420000 1. 000 1.000 

1100173500 11 Goji berry 1. 350000 1. 000 1. 000 

1100210000 11 Loquat 1.350000 1. 000 1.000 

1100266000 11 Pear 1. 350000 1. 000 1.000 

1100266001 11 Pear-baby food l. 350000 1 . 000 1. 000 

1100267000 11 Pear, dried l. 350000 6.250 1.000 

1100268000 11 Pear, juice l. 350000 1.000 1.000 

1100268001 11 Pear, juice-babyfood 1.350000 1 . 000 1.000 

1100310000 11 Quince 1.350000 1.000 1.000 

1201090000 12A Cherry 0.622000 1.000 1.000 

1201090001 12A Cherry-baby food 0.622000 1. 000 1.000 

1201091000 12A Cherry, j u ice 0.622000 1. 500 1. 000 

1201091001 12A Cherry, juice-babyfood 0.622000 1 . 500 1.000 

1202012000 12B Apricot 0.038000 1. 000 1 . 000 

1202012001 12B Apricot-babyfood 0.038000 1. 000 1.000 

1202013000 1 2B Apricot, dried 0.038000 6 . 000 1.000 

1202014000 12B Apricot, juice 0.038000 1 . 000 1.000 

1202014001 12B Apricot, juice-babyfood 0.038000 1.000 1.000 

1202230000 12B Nectarine 0.004000 1.000 1.000 

1202260000 12B Peach 0.038000 1.000 0.010 

1202260001 12B Peach-baby food 0.038000 1.000 0.010 

1202261000 12B Peach, dried 0.038000 7.000 0.010 

1202261001 12B Peach, dried-baby food 0.038000 7 . 000 0.010 

1202262000 12B Peach, juice 0.038000 1 . 000 0.010 

1202262001 12B Peach, juice-babyfood 0.038000 1.000 0.010 

1203285000 12C Plum 0.002500 1.000 1.000 

1203285001 12C Plum-babyfood 0.002500 1 . 000 1.000 

1203286000 12C Plum, prune, fresh 0.002500 1. 000 1.000 

1203286001 12C Plum, prune , fresh - babyfood 0 . 002500 1 . 000 1.000 

1203287000 12C Plum, prune, dried 0.002500 2.600 1. 000 

1203287001 12C Plum, prune, dried-babyfood 0 . 002500 2.600 1.000 

1203288000 12C Plum, prune, juice 0.002500 1. 400 1.000 

1203288001 12C Plum, prune, juice-babyf ood 0.002500 1. 400 1.000 

1302057000 13B Blueberry 1.009000 1.000 1.000 

1302057001 13B Blueberry-babyfood 1.009000 1.000 1.000 

1302136000 13B Currant 1.009000 1.000 1.000 

1302137000 13B Currant, dried 1.009000 1.000 1.000 

1302149000 13B Elderberry 1.009000 1.000 1.000 

1302174000 13B Gooseberry 1.009000 1.000 1.000 

1302191000 13B Huckleberry 1.009000 1 . 000 1.000 

1304175000 130 Grape 0. 613000 1.000 0.050 

1304176000 130 Grape, juice 0.005000 1.000 0.050 

1304176001 13 0 Grape, juice-ba b yfood 0.005000 1 . 000 0.050 

13 041 79000 130 Grape, wine and sherry 0.613000 1.000 0 . 050 

1307130000 13G Cranberry 1.009000 1.000 1.000 

1307130001 13G Cranberry-baby food 1. 009000 1 . 000 1.000 

1307131000 13G Cranberry, dried 1. 009000 1.000 1.000 

1307132000 13G Cranberry, juice 1.009000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 1.009000 1.100 1.000 

1307359000 13G Strawberry 0.495000 1. 000 0.025 

1307359001 13G Strawberry-babyfood 0. 4 95000 1.000 0.025 

1307360000 13G Strawberry, juice 0.495000 1.000 0.025 

1307360001 13G Strawberry, juice-babyfood 0.495000 1.000 0.025 

1400003000 14 Almond 0.005000 1.000 0.050 

1400003001 14 Almond- baby food 0 . 005000 1 . 000 0.050 

1400004000 14 Almond, oil 0.005000 1 . 000 0.050 

1400004001 14 Almond, oil-babyf ood 0 . 005000 1 . 000 0 . 050 

1400059000 14 Brazil nut 0.007000 1 . 000 1.000 

1400068000 14 Butternut 0.007000 1 . 000 1. 000 

1400081000 14 Cashew 0.007000 1. 000 1. 000 

1400092000 14 Chestnut 0.005000 1 . 000 1.000 

1400155000 14 Hazelnut 0.007000 1. 000 1.000 

1400156000 14 Hazelnut, oil 0.007000 1 . 000 1.000 

1400185000 14 Hickory nut 0.007000 1.000 1.000 

1400213000 14 Macadamia nut 0.007000 1. 000 1.000 

1400269000 14 Pecan 0.007000 1.000 0.025 

1400278000 14 Pine nut 0.007000 1. 000 1.000 

1400282000 14 Pistachio 0.005000 1. 000 0.025 

1400391000 14 Walnut 0.007000 1. 000 0.025 

1500025000 15 Barley, pearled barley 0.100000 1. 000 1. 000 

1500025001 15 Barley, pearled barley-babyfood 0 . 100000 1. 000 1.000 

1500026000 15 Barley, flour 0.100000 1. 000 1.000 

22of29 
Di fe noconazole Dietary Exposure Assessment DP#: 426491 

PC Code: 128847 

1500026001 15 Barley, flour-baby food 0.100000 1. 000 1.000 

1500027000 15 Barley, bran 0.100000 1.000 1.000 

1500127000 15 Corn, sweet 0.010000 1.000 1.000 

1500127001 15 Corn, sweet-baby food 0.010 000 1 . 000 1. 000 

1500231000 15 Oat, bran 0.010000 1.000 1. 000 

1500232000 15 Oat, flour 0.010000 1. 000 1.000 

1500232001 15 Oat, flour-babyfood 0.010000 1. 000 1. 000 

1500233000 15 Oat, groats/rolled oats 0.010000 1.000 1.000 

1500233001 15 Oat, groats/rolled oats-babyfood 0.010000 1. 000 1.000 

1500328000 15 Rye, grain 0.010000 1. 000 1.000 

1500329000 15 Rye, flour 0.010000 1. 000 1.000 

1500381000 15 Triticale, flour 0.100000 1.000 1.000 

1500381001 15 Triticale, flour-baby food 0.100000 1.000 1. 000 

1500401000 15 Wheat, grain 0.100000 1. 000 0.100 

1500401001 15 wheat, grain-babyfood 0.100000 1. 000 0.100 

1500402000 15 Wheat, flour 0.100000 1. 000 0.100 

1500402001 15 wheat, flour-baby food 0.100000 1.000 0.100 

1500403000 15 Wheat, germ 0.100000 1. 000 0.100 

1500404000 15 Wheat, bran 0.100000 1.000 0.100 

2001163000 20A Flax seed, oil 0.100000 1.000 1. 000 

2001319000 20A Rapeseed, oil 0.100000 1.000 1 .000 

2001319001 20A Rapeseed, oil-babyfood 0.100000 1.000 1.000 

2001336000 20A Sesame, seed 0.100000 1.000 1.000 

2001336001 20A Sesame, seed-babyfood 0.100000 1. 000 1. 000 

2001337000 20A Sesame, oil 0.100000 1. 000 l. 000 

2001337001 20A Sesame, oil -baby food 0.100000 1.000 1.000 

2003128000 20C Cottonseed, oil 0.050000 1.000 1.000 

2003128001 20C Cottonseed, oil- babyfood 0.050000 l. 000 1.000 

3100044000 31 Beef, meat 0.050000 1.000 1.000 

3100044001 31 Beef, mear.-babyfood 0.050000 1. 000 1. 000 

3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 

3100046000 31 Beef, meat byproducts 0.100000 1.000 1. 000 

3100046001 31 Beef, meat byproducts-babyfood 0.100000 1.000 1.000 

3100047000 31 Beef, fat 0.100000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0 . 100000 1. 000 1.000 

3100048000 31 Beef, kidney 0.100000 1. 000 1. 000 

3100049000 31 Beef. liver 0.400000 1. 000 1. 000 

3100049001 31 Beef, liver-babyfood 0.400000 1. 000 1. 000 

3200169000 32 Goat, meat 0.050000 1. 000 1.000 

3200170000 32 Goat, meat byproducts 0.100000 1.000 1.000 

3200171000 32 Goat, fat 0.100000 1.000 1. 000 

3200172000 32 Goat, kidney 0.100000 1.000 1. 000 

3200173000 32 Goat, liver 0. 400000 1. 000 1. 000 

3300189000 33 Horse. meat 0.050000 1. 000 1. 000 

3400290000 34 Pork, meat 0.050000 1. 000 1. 000 

3400290001 34 Pork, meat-babyfood 0.050000 1.000 l. 000 

34 00291000 34 Pork, skin 0.100000 1.000 1. 000 

3400292000 34 Pork, meat byproducts 0.100000 1.000 1. 000 

3400292001 34 Pork, meat byproducts-babyfood 0.100000 l. 000 1.000 

3400293000 34 Pork, fat 0.100000 1.000 1.000 

3400293001 34 Pork, fat - baby food 0.100000 l. 000 1.000 

3400294000 34 Pork, kidney 0.100000 1. 000 1. 000 

3400295000 34 Pork, liver 0. 400000 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 0.100000 l. 000 1. 000 

3500341000 35 Sheep, fat 0.100000 1. 000 1.000 

3500341001 35 Sheep, fat-babyfood 0.100000 1.000 1.000 

3 50034 2000 35 Sheep, kidney 0.100000 1.000 1. 000 

3500343000 35 Sheep, liver 0. 400000 1. 000 1. 000 

3600222000 36 Milk, fat 0.020000 1. 000 1. 000 

3600222001 36 Milk, fat-baby food/infant formu 0.020000 l. 000 l. 000 

3600223000 36 Milk, nonfat solids 0.020000 1.000 l. 000 

3600223001 36 Milk, nonfat solids-baby food/ in 0.020000 1.000 1.000 

3600224000 36 Milk, water 0.020000 1. 000 1. 000 

3600224001 36 Milk, water-babyfood/infant form 0.020000 l. 000 1. 000 

3600225001 36 Milk, sugar (lactose)-baby food / 0 . 020000 l. 000 1 . 000 

7000145000 70 Egg, whole 0.020000 l. 000 1. 000 

7000145001 70 Egg, whole-babyfood 0.020000 1.000 1.000 

7000146000 70 Egg, white 0.020000 l. 000 1. 000 

7000146001 70 Egg, white (solids)-babyfood 0.020000 1.000 1. 000 

7000147000 70 Egg, yolk 0.020000 1 . 000 1.000 

7000147001 70 Egg, yolk - baby food 0.020000 l. 000 1 . 000 

8601000000 86A water, direct, all sources 0.013600 1.000 1.000 

8602000000 86B water, indirect, all sources 0.013600 1.000 1.000 

9500016000 0 Artichoke, globe 0.469000 1.000 1.000 

9500023000 0 Banana 0.002500 1.000 1.000 

9500023001 0 Banana-babyfood 0 . 002500 1.000 1.000 

23 of29 
Difenoconazole Dietary Exposure Assessment DP#: 426491 

PC Code: 128847 

9500024000 0 Banana, dried 0.002500 3.900 1.000 

9500024001 0 Banana, dried-baby food 0.002500 3 . 900 l.000 

9500177000 0 Grape, leaves 0.613000 l.000 0.050 

9500178000 0 Grape. raisin 0.613000 3 . 500 0.050 

9500215000 0 Mango 0.070000 1. 000 1. 000 

9500215001 0 Mango-baby food 0.070000 1. 000 1.000 

9500216000 0 Mango, dried 0.070000 l.000 1. 000 

9500217000 0 Mango, juice 0 .070000 1. 000 l.000 

9500217001 0 Mango, juice-babyfood 0.070000 l. 000 l.000 

9500245000 0 Papaya 0. 013000 l. 000 1.000 

9500245001 0 Papaya - babyfood 0.013000 1.000 1.000 

9500246000 0 Papaya, dried 0.013000 l.800 1. 000 

9500247000 0 Papaya, juice 0. 013000 1.500 l.000 

9500283000 0 Plantain 0 . 002500 1.000 1.000 

9500284 000 0 Plantain, dried 0.002500 3.900 1.000 

24of29 
Difenoconazole 

PC Code: 128847 

Dietary Exposure Assessment DP#: 42649 1 

Attachment 4: DEEM-FCID Chronic Exposure Estimates 

US EPA 

DEEM - FCID Chronic analysis for DIFENOCONAZOLE 

Residue file name: C:\users\tmorton\Documents\My 

Difenoconazole 4E8274 Mar 2015 \1 28847Chronic Mar 

ver. 3.16 , 03 -08- d 

NHANES 2003-2008 2-day 

Files\ DEEM Files\12 8847 Di fenoconazole\128847 

2015 Food and Water.ROS 

Analysis Date 04-14-201S/07:14:49 

Reference dose (RfD, Chronic) = .01 

Adjustment factor #2 used. 

Residue file dated: 04-14-2015/07 :13:52 

mg/kg bw/day 

Total exposure by population subgroup 

Population 

Subgroup 

Total us Population 

Hispanic 

Non-Hisp-White 

Non- Hisp-Black 

Non- Hisp-Other 

Nursing Infan ts 

Non- Nursing Infants 

Female 13+ PREG 

Children 1 - 6 

Children 7 - 12 

Ma le 13-19 

Female 13-19/ NP 

Male 20+ 

Female 20+/NP 

Seniors SS+ 

All Infants 

Female 13 -50 

Children 1-2 

Children 3-5 

Children 6-1 2 

Youth 13-19 

Adults 20- 49 

Adults S0-99 

Fema le 13-49 

FOOD ONLY 

US EPA 

Total Exposure 

mg/kg 

body wt/ day 

0.002S91 

0 . 002761 

0.002499 

0.002689 

0.003154 

0.004996 

0.008894 

0. 002239 

0.006947 

0 . 003413 

0.002073 

0.001966 

0.002008 

0 .001940 

0.00 2096 

0 . 007691 

0 .0018S9 

0 .008894 

0.006043 

0.003709 

0 .002016 

0 . 001893 

0 .00209S 

0 .001856 

Percent of 

Rfd 

25.9\ 

27.6\ 

25.0\ 

26 . 9\ 

31. 5\ 

SO . O\ 

88.9\ 

22 . 4\ 

69.S\ 

34 .1\ 

20 . 7\ 

19.7\ 

20 . 1\ 

19. 4\ 

21. 0\ 

76 .9\ 

1 8.6\ 

88.9\ 

60. 4\ 

37 . H 

20 .2 \ 

1 8.9\ 

21. 0\ 

18 .6\ 

DEEM-FCID Chronic analysis for DIFENOCONAZOLE 

Residue file name : C: \ Users\tmorton\ Documents\My 

Difenoconazole 4E8274 Mar 201S\12884 7Chronic Mar 

Ver. 3 . 16, 03-08-d 

NHANES 2003-20 08 2-day 

Files\DEEM Files\128847 Difenoco nazole\ 12884 7 

2015 Food Only.ROB 

Analysis Date 04-14-201S/07 :15:08 

Reference dose (RfD , Chronic ) = .01 

Adjustment factor #2 used. 

Residue file dated: 04-14-2015/06 :Sl:34 

mg/kg bw/day 

=============== ===c==========••==== ====== ====================================== 

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 

Total exposure by population subgroup 

Total Exposure 

mg/kg 

body wt/ day 

0 . 002306 

0.002489 

0.002206 

0 . 002454 

0.002826 

0 .004739 

0.007947 

0. 001971 

0 . 006S82 

25 of29 

Percent of 

Rfd 

23.H 

24 . 9\ 

22 .1\ 

24.5\ 

28. 3\ 

4 7. 4\ 

79 .St 

19 .7\ 

65 .8 \ 
Difenoconazole Dietary Exposure Assessment DPff: 426491 

PC Code: 128847 

Children 7-12 0.003176 31. 8\' 

Male 13-19 0 . 001877 18 . 8\' 

Female 13-19/NP 0 . 001747 17 . 5\' 

Male 20+ 0 . 001743 17 . 4\' 

Female 20+/NP 0 . 001641 16 . 4\' 

Seniors 55+ 0 . 001821 18.2\' 

All Infants 0.006957 69 . 6\' 

Femal e 13-50 0 . 001576 15 . 8\' 

Children 1 -2 0.0084 83 8 4. st 

Children 3-5 0.005697 57 . 0\' 

Children 6-12 0 . 003459 34 . 6\' 

Youth 13-19 0 . 001809 18 . 1\ 

Adults 20-49 0 . 001609 16 . 1\ 

Adults 50-99 0 . 001815 18 . H 

Female 13 - 49 0 . 001573 15 . 7\ 

26 of29 
Difenoconazole 

PC Code: 12884 7 

Dietary Exposure Assessment 

Attachment 5: Percent Crop Treated Memorandum 

Difenoconazole (128847) 

Screening Level Usage Analysis (SLUA) 

Date: October 2, 2014 

What is a Screening Level Usage Analysis (SL UA)? 

DP#: 426491 

• Available estimates of pesticide usage data for a particular acti ve ingredient that is 

used on agricultural crops in the United States. 

• Pesticide usage data obtained from various sources. The data are then merged, 

averaged, and rounded so that the presented information is not proprietary, business 

confidentia l, or trade secret. 

What does it contain? 

• Pesticide usage data for a single acti ve ingredient only. 

• Agricultural use sites (crops) that the pesticide is reported to be used on. 

• Available pesticide usage information from U.S. states that produce 80% or more of a 

crop, in most cases, or less than 80%, in rare cases, depending on the scope of the 

survey and available resources. 

• Annua l percent of crop treated (average & maximum) for each agricultural crop. 

• Average annua l pounds of the pesticide applied for each agricultural crop (i.e., for the 

states surveyed, not for the entire United States). 

What assumptions can I make about the reported data? 

• Average pounds of active ingredient applied - Values are calcul ated by merging 

pesticide usage data sources together; averaging across all observations, then 

rounding. Note: If the estimated value is less than 500, then that value is labeled 

<500. Estimated values between 500 & <l ,000,000 are rounded to I significant 

digit. Estimated values of I, 000, 000 or greater are rounded to 2 significant digits.) 

• Average percent of crop treated - Values are calculated by merging data sources 

together; averaging by year, averaging across all years, & rounding to the nearest 

multiple of 5. Note: If the estimated value is less than 2.5, then the value is labeled 

<2.5. If the estimated value is less than I . then the value is labeled <l. 

• Maximum percent of crop treated - Value is the single maximum value reported 

across all data sources, across all years, & rounded up to the nearest multiple of 5. 

Note: If the estimated value is less than 2.5, then the value is labeled <2.5. 

What a r e the data sources used? 

• USDA-NASS (United States Department of Agriculture's Nationa l Agricultural 

Statistics Service) - pesticide usage data from 2004 to 20 12. 

• Private pesticide market research - pesticide usage data from 2004 to 2012. 

• California Department of Pesticide Regulation (DPR) Pesticide Use Reporting 

(PUR) data for 2004 to 20 11 . 

What a re the limitations to the data? 

• Additional registered uses may exist but are not included because the available 

surveys do not report usage (e.g., small acreage crops). 

• Lack of reported usage data for the pesticide on a crop does not imply zero usage. 

• Usage data on a particular site may be noted in data sources, but not quantified. In 

these instances, the site would not be reported in the SLUA. 

27of 29 
Di fenoconazole 

PC Code: 128847 

Dietary Exposure Assessment DP#: 426491 

• Non-agricultural use sites (e.g., turf, post-harvest, mosquito control, etc.) are not 

reported in the SLUA. A separate request must be made to receive these estimates. 

• Some sites show some use, even though they are not on the label. This usage could 

be due to various factors, including, but not limited to Section 18 requests, existing 

stocks of the chemical, data collection errors, and experimental use permits (EUPs). 

28 of29 
Difenoconazole 

PC Code: 128847 

Dietary Exposure Assessment DP#: 42649 1 

Date: October 2, 2014 

Screening Level Estimates of Agricultural Uses of Difenocooazole ( 128847) 

Sorted Alphabetically 

R eportme: Y ears: 2004 -2012 

Average Percent Crop Treated 

Crop Lbs. A.I. Average Maximum 

I Almonds 

2 Aooles 

3 Brussels Sprouts • 

4 Cabbage 

5 Cantaloupes 

6 Cucumbers 

7 Garlic 

8 Grapefruit 

9 Grapes 

10 Onions 

11 Oranges 

12 Peaches 

13 Pears 

14 Pecans 

15 Pcooers 

16 Pistachios 

17 Potatoes 

18 Pumpkins 

19 Squash 

20 Strawberries 

21 Sugar Beets 

22 Tangerines 

23 Tomatoes 

24 Walnuts 

25 Watermelons 

26 Wheat (Seed Treatment) 

All numbers are rounded. 

<500: less than 500 pounds of active ingredients. 

<2.5: less than 2.5 percent of crop is treated. 

<I: less than I percent of crop is treated. 

7,000 5 

7,000 15 

<500 NC 

<500 <2.5 

<500 <2.5 

3,000 5 

<500 5 

<500 <> _,) ~ 

9,000 5 

2,000 5 

1,000 <2.5 

<500 < I 

<500 5 

1,000 <2.5 

<500 <2.5 

<500 <2.5 

20,000 15 

<500 <> _,) ~ 

<500 5 

<500 <2.5 

20,000 15 

1,000 <2.5 

7,000 r _) 

<500 <2.5 

2,000 5 

40,000 10 

* Based on CA DPR data only (80% or more of U.S. acres grown are in California) 

NC: not calculated, on ly pounds a.i. available. 

SLUA data sources include: 

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

Private Pesticide Market Research 

California DPR (Department of Pesticide Regulation) 

These results renect amalgamated data developed by the Agency and are releasable to the public. 

29 of29 

15 

25 

NC 

5 

<2.5 

10 

5 

<2.5 

10 

10 

<2.5 

<2.5 

10 

<2.5 

5 

5 

30 

5 

10 

<2.5 

30 

<2.5 

40 

<2.5 

10 

15