Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



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**UNITED STA TES ENVIRONMENTA**  **L PROTECTION A GENCY** 

**WA SHINGTON, D.C. 20460**  **Office of Chemical Safety and Pollution Prevention** 

### MEMORANDUM Date: 1 5 - January- 20 1 5 Subject: **Difenoconazole.** Acute and Chronic Aggregate Dietary Exposure and Risk Assessments for the Petition for Use of Difenoconazole on Rapeseed Crop Subgroup 20A and Imported Dragonfruit . PC Code: 128847 DP Barcode: 412812 & 42 2170 Decision No.: 473631 & 493233 Registration No. : 100 - 1262 Petition Nos.: 2F8134 & 4E8296 Regulatory Action: Amended Section 3 Assessment Type: Single Chemical, Dietary Registration Case No.: NA T XR No.: None CAS No.: 119446 - 68 - 3 MRID No.: None 40 CFR: 180.475 

### Reviewer: Thurston G. Morton , Chemist

Risk Assessment Branch IV/Health Effects Division (RABIV/HED; 7509 P ) Through: Tom Bloem , Chemist

William Cutchin , Chemist Dietary Exposure Science Advisory Council (DESAC) And Elissa Reaves PhD. , Branch Chief RABIV/HED (7509P) To: Thurston G. Morton , Risk Assessor

RABIV/HED (7509 P ) And Rosemary

Kearns/Tony Kish (RM 22 ) Fungicide Branch Registration Division (7505P)

**Executive Summary**Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 2 of 22 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/WWEIA). This dietary survey was conducted from 2003 to 2008. The anal ys es were performed to support the Section 3 registration on Rapeseed Crop Subgroup 20A of the fungicide difenoconazole [1 - [2 - [2 - chloro - 4 - (4 - chlorophenoxy)phenyl ] - 4 - methyl - 1,3 - dioxolan - 2 - yl methyl] - 1 H - 1,2,4 - triazole] and the use of difenoconazole on imported dragonfruit . This memorandum was reviewed b y two peer reviewers of the DESAC, per DESAC SOP 2012.1. The unrefined acute analys i s assumed tolerance - level residues , 100% 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 for the majority

of commodities, the available empirical or DEEM  (ver. 7.81) default processing factors, and 100 % CT. The EDWC of 20.0 μg/L (ppb ) was used for the acute dietary exposure anal ys is and an estimated drinking water concentrations (EDWC) of 13.6 μg/L (ppb) was used for the chronic dietary exposure anal ys is. The resulting acute food plus water exposure estimates were less than HED’s level of concern ( - <100 % of the acute population - adjusted dose (aPAD)) at the 95 th 

### percentile of the exposure distribution for the general U . S . population ( 12 % aPAD) and all population sub - groups; the most highly

exposed population subgroup was children 1 - 2 ye ars old with 27 % aPAD. The resulting chronic food plus water exposure estimates were less than HED’s level of concern ( - <100 % of the chronic population - adjusted dose (cPAD) ) for the general U . S . population ( 30 % cPAD) and all population sub - groups; the most highl y exposed population subgroup was children 1 - 2 years old with 7 5 % cPAD. No cancer anal ys is was performed since it was determined the chronic dietary exposure assessment is protective of cancer effect s. **The dietary exposure analyses for the triazole metabolites**  **w ere**  **updated (** **D 414951**  **, T**  **. Morton**  **, 24**  **Oct . 20**  **1 3**  **)** .

**I. Introduction**Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 3 of 22 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 unreasona ble adverse health effects). This dose is referred to as the PAD. The PAD is equivalent to the point of departure (POD, NOAEL, LOAE L, e.g.) divided by the required uncertainty or safety factors. For acute and non - cancer chronic exposures, HED is concern ed when estimated dietary risk exceeds 100% of the PAD. HED is generall y concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21 - JUN - 2000, web link: http://www.epa.gov/fedrgstr/EPA PEST/2000/July

/Day- 12/6061.pdf

; or see SOP 99.6 (20 - AUG - 1999). The most recent dietary

risk assessment for difenoconazole was conducted by T. Morton ( 30 - May- 20 1 2 ; DP# 397664 ). **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 a ssessment 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 from the phenyl - labeled study, should be considered as a residue of concern for the dietary

risk assessment. Based on available goat metabolism data, total residues of concern in milk f

or dietary risk assessments (parent, CGA - 205375, and OH - CGA - 169374), should be calculated b y multiplying the tolerance in milk by a factor of 1.5x. Table 1 summarizes tolerance expression and the residues of concern in plant and livestock commodities. **Ta ble**  **1 . Difenoconazole Residues of Concern in Plants and Ruminants.** 

**Matrix Residues of Concern**  **For Risk Assessment For Tolerance Expression**  Plants Primary and Rotational crops Parent Only Parent Only Livestock Ruminant and Poultry Parent and CGA 205375 Parent and CGA 205375

Milk Parent, CGA 205375 and OH - CGA - 169374 Parent and CGA 205375 Drinking Water Parent Only NA Note: The triazole - containing metabolites 1,2,4 - T, TA, and TAA 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 traizole - derivative fungicides and because of differential toxicity between metabolites and the various parent compounds, risks associated with exposure to 1,2,4 - T and to TA/TAA are addressed separately. 

### Recommended Tolerances : Based on the residue chemistry data submitted with the previous petitions, HED recommended for establishment of the new food toleranc es (DP# 412810 , B .Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

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### 4 of 22 Cropp - Ko hlligian , 22 - August - 20 1 3 ). The recommended , established, and revised tolerances are listed in Table 2 below. **Table 2 . Tolerance Summary for Difenoconazole**  **(non feed items) .**  Commodity Existing/Established Tolerances (ppm) New Tolerances (ppm) Rapeseed crop subgroup 20A ----- 0.10 Almond, nutmeat 0.0 3 ------ Brassica subgroup 5A 1.9 ------ Brassica subgroup 5B 35 ------ Citrus oil 25 ------ Fruit, citrus, group 10 0.6 ------ Grape 4.0 ------ Grape, raisin 6.0 ------ Nut, tree, group 14 0.03 ------ Onion, bulb, subgroup 3

—07A 0.20 ------ Onion, green, subgroup 3

—07B 6.0 ------ Pistachios 0.03 ------ Vegetable, cucurbit, group 9 0.7 ------ Fruit, Pome, group 11 1.0 ------ Vegetable, Fruiting, Group 8 0.60 ------ Vegetable, Tuberous and Corm, subgroup 1C **4.0 4.0**  Beet, sugar 0.30 ------ Papaya 0.30 ------ Banana 0.2 ------ Barley, grain 0.1 ------ Canola, seed 0.01 ------ Cattle fat 0. 10 ------ Cattle, meat 0.05 ------ Cattle, meat byproducts 0.10 ------ Cattle, liver 0. 4 0 ------ Corn, sweet, kernel plus cob with husks removed 0.01 ------ Cotton, undelinted seed 0.0 5 ------ Egg 0. 02 ------ Goat, fat 0.10 ------ Goat, meat 0.05 ------ Goat, meat byproducts (except liver) 0.10 ------ Goat, liver 0. 4 0 ------ Hog, fat 0.10 ------ Hog, meat 0.05 ------ Hog, meat byproducts (except liver) 0.1 ------ Hog, liver 0. 4 0 ------Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

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### 5 of 22 **Table 2 . Tolerance Summary for Difenoconazole**  **(non feed items) .**  Commodity Existing/Established Tolerances (ppm) New Tolerances (ppm) Horse, fat 0.10 ------ Horse, meat 0.05 ------ Horse, meat byproducts (except liver) 0. 10 ------ Horse, liver 0. 4 0 ------ Milk 0.01 ------ Rye, grain 0. 0 1 ------ Sheep, fat 0. 10 ------ Sheep, meat 0.05 ------ Sheep, meat byproducts (except liver) 0. 10 ------ Sheep, liver 0. 40 ------ Wheat, grain 0.1 ------ Wax apple 0.07 ------ Mango 0.07 ------ Carrot 0.50 ------ Chickpea 0.08 ------ Soy bean, seed 0.15 ------ Fruit, stone, group 12 2.5 ------ Straw berry 2.5 ------ Turnip greens 35 ------ Oat, grain 0.01 ------ Wax Jambu 1.5 Dragonfruit 1.5 (translated from wax jambu) 

### The **dietary exposure analyses for the triazole metabolites (D**  **414951 , T.**  **Morton ,**  **24 Oct**  **. 201**  **3 )**  **was updated**  . Food Residues and processing factors used in the Acute and Chronic Analysis : The acute anal ys i s assumed tolerance - level residues and 100% CT for all the registered and proposed crops. T olerance - level residues were also assumed for all livestock tissues in this assessment. The chronic anal ys is as sumed tolerance - level residues for some commodities, average field trial residues for the majority

of commodities, and 100 % CT . Those commodities where field trial data were u sed are summarized below. 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 dated 9/12/2000 was used in translating to other commoditie s in the crop group. Experimental processing factors were used for apple juice (0.04x), grape juice (0.2x), citrus juices (0.1x), 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 process ing factors were assumed for other processed commodities. Almond : Field trial residues were used from MRID 47586101.Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

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### 6 of 22 Apple : Field trial residue s were used from MRID 46950233. Broccoli : Field trial residues were used from MRID 47586102. Residues from 1 - 7 day PHI were used since registered labels allow from 1 - 7 day PHI s. Cabbage : Field trial residues were used from 47586102. Residues from 1 - 7 day PHIwere 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 : Field trial residues were used from MRID 4758610 3 . Residues from 0 - 1 day PHI were used since registered labels allow from 0 - 1 day PHI . Carrot : Field trial residues were used from MRID 47929804. Chickpea : Field trial residues were used from MRID 47929805. Cucumber : Field trial residues were used from MRID 47586103. Resi dues from 0 - 1 day PHI were used since registered labels allow from 0 - 1 day PHI . Grape : Field trial residues were used from MRID 47586105. Grapefruit : Field trial residues were used from MRID 47586104. Lemon : Field trial residues were used from MRID 47586104. Lime : Field trial residues were used from MRID 47586104. Mustard Greens : Field trial residues were used from MRIDs 47417704, 47417707, and 47586102. Residues from 1 - 7 day PHI were used since registered labels allow from 1 - 7 day PHI s. Orange : Field trial residues were used from MRID 47586104. Pear : Field trial residues were used from MRID 46950233. Pecan : Field trial residues were used from MRID 47586106. Peppers : Field trial residues were used from MRID 46950234. Potato : Field trial residues were used from MRID 47929804 . Soy bean : Field trial residues were used from MRID 47929801. Stone Fruit : Field trial residues were used from MRID 47929803. Strawberry : Field trial residues were used from MRID 47929802. Sugar Beet : Field trial residues were used from MRID 46950236.Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

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### 7 of 22 Summer Squash : Field trial residues were used from MRID 47586103. Residues from 0 - 1 day PHIwere used since registered labels allow from 0 - 1 day PHI s . Tomato : Field trial residues were used from MRIDs 46950234, 47417705, and 47417708. **III. Percent Crop Treated Information** The acute and chronic dietary exposure analyses assumed 100% crop treated (CT). **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 , 14 - August - 201 3 ; D 412614 ). For surface water, the EDWCs for canola/ oilseed subgroup 20A did not exceed the peak (acute) concentration of 17.4 μg/L, annual mean (non - cancer chronic) concentration of 11.8 μg/L and the 30 year annual average concentration (cancer chronic) of 8.6 μg/L for use on grape reported in the previous drinking water assessment (US EPA, 2012b; DP 398836 ). Therefore, the EDWCs for surface water for canola/ oilseed subgroup 20A (Table 1) did not supersede the previously

recommended drinking water concentrations. However, the previously recommended EDWCs were based on 0.87 PCA (Percent Cropped Area**)** facto r. Recently, EFED implemented a revised guidance for P CA (USEPA 2012a). Since difenoconazole can be used in both non agricultural (turf

) and various agricultural crops , a PCA of 1.0 factor was u sed to revise previously

recommended EDWCs for grape. For surf ace water, revised recommended EDWCs are 20.0 μg/L for peak, 13.6 μg/L for annual mean and 9.9μg/L for annual average concentrations Estimated PZRM - GW ground water acute concentration of 2.24 μg/L and chronic concentration of 0.82 μg/L are higher than the previousl y recommended concentration of 1.30x 10 - 2 

### μg/Lfor citrus (US EPA, 2011; D395784). Therefore, the current EDWCs superseded the previously recommended EDWCs for groundwater. Recommended EDWCs for human health are **20.0** μg/L(ppb) for the acute dietary (food plus water) exposure anal ys is and the 1 - 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** Difenoconazole acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM - FCIDTM, Version 3.16, which incorporates consumption data from USDA’s National Health and Nutriti on 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 publicl y available recipe translation files developed jointly by USDA/ARS and EPA. F or 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 consump tion data, which took into accountDifenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

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### 8 of 22 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 (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50 - 99 years old. For chronic dietary

exposure assessment, an estimate of the residue level in each food or food form ( e .g. , orange or orange juice) on the food commodity residue list is multiplied by the average dail y 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 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 aPAD on both a user ( i.e. , those who reported eating relevant commodities/food for

ms) 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 anal ysis. 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 di fenoconazole and re - assessed the RfD 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). InJuly , 2007, the RAB1 toxicologists and risk assessment team met to reevaluate the endpoints selected by the HIARC since new studies were submitted. RAB1 toxicologists and risk assessment team also reevaluated FQPA assessments. The risk assessment team concluded that the default 10x FQPA Safety Factor (SF) should be reduced to 1x when assessing acute and chronic dietary exposures (M. Sahafeyan, D333320, 09 - AUG - 07) . The relevant endpoints are shown in Table 3. In accordance with HED’s current policy and EPA’s 2005 Cancer Guidelines, difenoconazole is classified as “Suggestive Evidence of Carcinog enic Potential,” b ased 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. U se 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 i s not being conducted for difenoconazole.Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

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### 9 of 22 **Table 3. Summary of Toxicological Doses and Endpoints for Difenoconazole for Use in Dietary Risk**  **Assessments. Exposure**  **Scenario Point of** 

**Departure Uncertainty/FQPA** 

**Safety Factors RfD, PAD, for Risk**  **Assessment Study and Relevant**  **Toxicological Effects** Ac ute Dietary (All populations) NOAEL =

25 mg/kg UF A = 10X

UF H = 10X FQPA SF = 1X aRfD = aPAD = 0.25

mg/kg/day **Acute Neurotoxicity Study in Rats**  LOAEL= 200 mg/kg in males based on reduced fore - limb grip strength in males on day 1. Chronic Dietary (All populations) NOAEL =

0.96 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X cRfD = cPAD =

0.01mg/kg/day **Combined chronic toxicity/carcinogenicity**  **(rat; dietary)** LOAEL = 24.1 /32.8 mg/kg/day (M/F) based on cumulative decreases in body - weight gains . Cancer (oral, dermal, inhalation) Difenoconazole is classified as a Group C, possible human carcinogen with a non - linear (MOE)

approach for human risk characterization (CPRC Document, 7/27/94, Memo, P. V. Shah dated March 3, 2007, HED Doc. No. 0054532) . The chronic dietary exposure assessment is protective of cancer effects. Point of Departure (POD) = A data point 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. NOAEL = no ob served adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human ( inter species ). UF H = potential variation in sensitivity among members of the human population ( intra species ). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference do se. 

### VII. Results/Discussion As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the aPAD or cPAD, respectivel y. The following paragraphs are summaries of the DEEM - FCID  (ver. 2.03) acute and chronic exposure anal ys es. Acute and chronic aggregate (food + water) anal yses 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 95 th 

### percentile of the exposure distribution for general US population ( 1 1 % aPAD) and all population sub - groups; the most highly exposed population subgroup was Children 1 - 2 ye ars old with 2 9 % aPAD. The resulting chronic food exposure estimates were less than HED’s level of concern ( <100 % cPAD) for the general U . S . population (27 % cPAD) and all population sub - groups; the most highly exposed population subgroup was children 1 - 2 years old with 7 8 % cPAD. A separate cancer dietary assessment was not conducted for difenoconazole because the cancer NOAEL is higher than the chronic RfD; therefore, the chronic dietary risk estimate is considered protective of all chronic effects including carcinogenicity . **Table 4 .**  **Summary of A**  **cute Dietary (Food plus Water)**  **Exposure and Risk for Difenoconazole at the 95 th**  **Percentile.**Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

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### 10 of 22 **Population Subgroup aPAD (m** **g/kg/day) Exposure (mg/kg/day)**  **% a**  **PAD** General U.S. Population

0.25 0.0 2 8053 1 1 All Infants (< 1 year old) 0. 0 56 908 23 **Children 1 -**  **2 years old 0.**  **0 7**  **1431 2**  **9** Children 3 - 5 years old 0.0 50407 2 0 Children 6 - 12 years old 0.0 3 3218 1 3 Youth 13 - 19 years old 0.0 17 774 7. 1 Adults 20 - 49 years old 0.0 2 0 285 8. 1 Adults 50 - 99 years old 0.0 2 3 527 9. 4 Females 13 - 49 years old 0.0 20231 8. 1 The bolded %aPAD is the highest. **Table 5**  **. Summary of Chronic Dietary**  **(Food plus Water) Exposure and Risk for Difenoconazole.**  **Population Subgroup cPAD (m** **g/kg/day) Exposure (mg/kg/day)**  **%cPAD** General U.S. Population

0.01 0.00 2 6 85 27 All Infants (< 1 year old) 0.00 4 7 96 4 8 **Children 1 -**  **2 years old 0.00**  **7 816**  **7 8**  Children 3 - 5 years old 0.00 5 781 5 8 Children 6 - 12 years old 0.00 3 616 3 6 Youth 13 - 19 years old 0.00 2 0 69 2 1 Adults 20 - 49 years old 0.00 2 1 4 4 2 1 Adults 50 - 99 years old 0.00 2 3 48 2 4 Females 13 - 49 years old 0.00 2 0 92 2 1 The bolded %cPAD is the highest. 

### VIII. **Characterization of Inputs/Outputs** The acute anal ys i s assumed tolerance - level residues, 100% CT, and empirical or DEEM default processing factors . The chronic anal ys is assumed tolerance - level residues for some commodities, average field trial residues for the majority of commodities, 100 % CT , and empirical or DEEM default processing factors . Therefore, these anal ys es are considered conservative . While they could be significantl y refined, further refinement is not warranted as estimated risks are not of concern. **IX. Conclusions** An acute aggregate (food + water) dietary risk assessment was conducted for difenoconazo le using the DEEM - FCID  (ver. 2.03) M odel 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 for the majority of commodities, 1 00 % CT , and empirical or DEEM default processing factors . The resulting acute and chronic aggregate exposure estimate s w ere less than HED’s level of concern . For the general U.S. population, the aPAD and cPAD were 1 1 % and 27 %, respectivel y. TheDifenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

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### 11 of 22 most highly- exposed population subgroups in the acute ( at the 95 th 

### percentile of the exposure distribution) and chronic anal ys es were Children 1 - 2 ye ars old (2 9 % aPAD) and children 1 - 2 ye ars old ( 7 8 % cPAD) , respectivel y.

**X. List of Attachments** Attachment 1 : DEEM -FCID  Acute Residue File Attachment 2 : DEEM -FCID  Acute Exposure Estimates Attachment 3 : DEEM -FCID  Chronic Residue File Attachment 4 : DEEM -FCID  Chronic Exposure Estimates c c with all attachments: T . Morton (RAB IV) RDI: T. Bloem and W. Cutchin - DESAC ( 26 - January - 20 1 3 ) ; E . Reaves ( 30 - May - 201 2 ) Petition Number(s): 2F8134 PC Code: 128847 T . Morton :S10 838 :PY1:(703)305 - 6691Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

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### 12 of 22 **Attachment 1 : DEEM** **- FCID**   **Acute Residue File** Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 128847 Difenoconazole \ Petition 2F8134 Oilseeds 20A \ 128847 Acut e Aug 2013.R08 Chemical: Difenoconazole RfD(Chronic): .01 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .25 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 09 - 25 - 2013/08:08:55 Program ver. 3.16, 03 - 08 - d

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101052000 1A Beet, sugar 0.300000 1.000 1.000 0101052001 1A Beet, sugar - babyfood 0.300000 1.000 1.000 0101053000 1A Beet, sugar, molas ses 0.300000 0.600 1.000 0101053001 1A Beet, sugar, molasses - babyfood 0.300000 0.600 1.000 0101078000 1AB Carrot 0.500000 1.000 1.000 0101078001 1AB Carrot - babyfood 0.500000 1.000 1.000 0101079000 1AB Carrot, juice 0.500000 1.000 1.000 0103015000 1CD Arrowroot, flour 4.000000 1.000 1.000 0103015001 1CD Arrowroot, flour - babyfood 4.000000 1.000 1.000 0103017 000 1CD Artichoke, Jerusalem 4.000000 1.000 1.000 0103082000 1CD Cassava 4.000000 1.000 1.000 0103082001 1CD Cassava - babyfood 4.000000 1.000 1.000 0103139000 1CD Dasheen, corm 4.000000 1.000 1.000 0103166000 1CD Ginger 4.000000 1.000 1.000 0103166001 1CD Ginger - babyfood 4.000000 1.000 1.000 0103167000 1CD Ginger, dried 4.0000 00 1.000 1.000 0103296000 1C Potato, chips 4.000000 0.500 1.000 0103297000 1C Potato, dry (granules/ flakes) 4.000000 0.500 1.000 0103297001 1C Potato, dry (granules/ flakes) - b 4.000000 0.500 1.000 01032 98000 1C Potato, flour 4.000000 0.500 1.000 0103298001 1C Potato, flour - babyfood 4.000000 0.500 1.000 0103299000 1C Potato, tuber, w/peel 4.000000 1.000 1.000 0103299001 1C Potato, tuber, w/peel - babyfood 4.000000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 4.000000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel - babyfood 4.000000 1.000 1.000 0103366000 1CD Sweet potato 4.00 0000 1.000 1.000 0103366001 1CD Sweet potato - babyfood 4.000000 1.000 1.000 0103371000 1CD Tanier, corm 4.000000 1.000 1.000 0103387000 1CD Turmeric 4.000000 1.000 1.000 0103406000 1CD Yam, true 4.000000 1.000 1.000 0103407000 1CD Yam bean 4.000000 1.000 1.000 0301165000 3A Garlic, bulb 0.200000 1.000 1.000 0301165001 3A Garlic, b ulb - babyfood 0.200000 1.000 1.000 0301237000 3A Onion, bulb 0.200000 1.000 1.000 0301237001 3A Onion, bulb - babyfood 0.200000 1.000 1.000 0301238000 3A Onion, bulb, dried 0.200000 9.000 1.000 0301238001 3A Onion, bulb, dried - babyfood 0.200000 9.000 1.000 0301338000 3A Shallot, bulb 0.200000 1.000 1.000 0302103000 3B Chive, fresh leaves 6.000000 1.000 1.000 0302198000 3B Leek 6.000000 1.000 1.000 0302239000 3B Onion, green 6.000000 1.000 1.000 0302338500 3B Shallot, fresh leaves 6.000000 1.000 1.000 0501061000 5A Broccol i 1.900000 1.000 1.000 0501061001 5A Broccoli - babyfood 1.900000 1.000 1.000 0501062000 5A Broccoli, Chinese 1.900000 1.000 1.000 0501064000 5A Brussels sprouts 1.900000 1.000 1.000 0501069000 5A Cabbage 1.900000 1.000 1.000 0501071000 5A Cabbage, Chinese, napa 1.900000 1.000 1.000 0501072000 5A Cabbage, Chinese, mustard 1.900000 1.000 1.00 0 0501083000 5A Cauliflower 1.900000 1.000 1.000 0501196000 5A Kohlrabi 1.900000 1.000 1.000 0502063000 5B Broccoli raab 35.000000 1.000 1.000 0502070000 5B Cabba ge, Chinese, bok choy 35.000000 1.000 1.000 0502117000 5B Collards 35.000000 1.000 1.000 0502194000 5B Kale 35.000000 1.000 1.000 0502229000 5B Mustard greens 35.000000 1.000 1.000 0502318000 5B Rape greens 35.000000 1.000 1.000 0502389000 5B Turnip, greens 35.000000 1.000 1.000 0600347000 6 Soybean, seed 0.150000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 13 of 22 0600349000 6 Soybean, soy milk 0.150000 1.000 1.000 0600349001 6 Soybean, soy milk - babyfood or in 0.150000 1.000 1.000 0600350000 6 Soybean, oil 0.150000 1.000 1.000 0600350001 6 Soybean, oil - babyfood 0.150000 1.000 1.000 0601349500 6AB Soybean, vegetable 0.150000 1.000 1.000 0603098000 6C Chickpea, seed 0.080000 1.000 1.000 0603098001 6C Chickpea, seed - babyfood 0.080000 1.000 1.000 0603099000 6C Chickpea, flour 0.080000 1.000 1.000 0603348000 6C Soybean, flour 0.150000 1.000 1.000 0603348001 6C Soybean , flour - babyfood 0.150000 1.000 1.000 0801374000 8A Tomatillo 0.600000 1.000 1.000 0801375000 8A Tomato 0.600000 1.000 1.000 0801375001 8A Tomato - babyfood 0.600000 1.000 1.000 0801376000 8A Tomato, paste 0.600000 1.600 1.000 0801376001 8A Tomato, paste - babyfood 0.600000 1.600 1.000 0801377000 8A Tomato, puree 0.600000 0.500 1.00 0 0801377001 8A Tomato, puree - babyfood 0.600000 0.500 1.000 0801378000 8A Tomato, dried 0.600000 14.300 1.000 0801378001 8A Tomato, dried - babyfood 0.600000 14.300 1.000 0801379000 8A Tomat o, juice 0.600000 1.500 1.000 0802148000 8BC Eggplant 0.600000 1.000 1.000 0802234000 8BC Okra 0.600000 1.000 1.000 0802270000 8B Pepper, bell 0.600000 1.000 1.000 0802270001 8B Pepper, bell - babyfood 0.600000 1.000 1.000 0802271000 8B Pepper, bell, dried 0.600000 1.000 1.000 0802271001 8B Pepper, bell, dried - babyfood 0.600000 1.000 1.000 0802272000 8BC Pepper, nonbell 0.600000 1.000 1.000 0802272001 8BC Pepper, nonbell - babyfood 0.600000 1.000 1.000 0802273000 8BC Pepper, n onbell, dried 0.600000 1.000 1.000 0901075000 9A Cantaloupe 0.700000 1.000 1.000 0901187000 9A Honeydew melon 0.700000 1.000 1.000 0901399000 9A Watermelon 0.700000 1.000 1.000 0901400000 9A Watermelon, juice 0.700000 1.000 1.000 0902021000 9B Balsam pear 0.700000 1.000 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 1.000 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 1.000 1.000 0902357001 9B Squash, winter - babyfood 0.700000 1.000 1.000 1001106000 10A Citron 0.600000 1.000 1.000 1001107000 10A Citrus hybrids 0.600000 1.000 1.00 0 1001108000 10A Citrus, oil 25.000000 1.000 1.000 1001240000 10A Orange 0.600000 1.000 1.000 1001241000 10A Orange, juice 0.600000 0.100 1.000 1001241001 10A Orang e, juice - babyfood 0.600000 0.100 1.000 1001242000 10A Orange, peel 0.600000 1.000 1.000 1001369000 10A Tangerine 0.600000 1.000 1.000 1001370000 10A Tangerine, juice 0.600000 0.100 1.000 1002197000 10B Kumquat 0.600000 1.000 1.000 1002199000 10B Lemon 0.600000 1.000 1.000 1002200000 10B Lemon, juice 0.600000 0.100 1.000 1002200001 10B Lemon, juice - babyfood 0.600000 0.100 1.000 1002201000 10B Lemon, peel 0.600000 1.000 1.000 1002206000 10B Lime 0.600000 1.000 1.000 1002207000 10B Lime, juice 0.600000 0.100 1.000 1002207001 10B Lime, juice - babyfood 0.600000 0.100 1.000 1003180000 10C Grapefruit 0.600000 1.000 1.000 1003181000 10C Grapefruit, juice 0.600000 0.100 1.000 1003307000 10C Pummelo 0.600000 1.000 1.000 1100007000 11 Apple, fruit with peel 1.000000 1.000 1.000 1100008000 11 Apple, peeled fruit 1.000000 1.000 1.000 1100008001 11 Apple, peeled fruit - babyfood 1.000000 1.000 1.000 1100009000 11 Apple, dried 1.000000 8.000 1.000 1100009001 11 Apple, dried - babyfood 1.000000 8.000 1.000 1100010000 11 Apple, juice 1.000000 0.040 1.000 1100010001 11 Apple, juice - babyfood 1.000000 0.040 1.000 1100011000 11 Apple, sauce 1.000000 1.000 1.000 1100011001 11 Apple, sauce - babyfood 1.000000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 14 of 22 1100129000 11 Crabapple 1.000000 1.000 1.000 1100173500 11 Goji berry 1.000000 1.000 1.00 0 1100210000 11 Loquat 1.000000 1.000 1.000 1100266000 11 Pear 1.000000 1.000 1.000 1100266001 11 Pear - babyfood 1.000000 1.000 1.000 1100267000 11 Pear, dried 1.000000 6.250 1.000 1100268000 11 Pear, juice 1.000000 1.000 1.000 1100268001 11 Pear, juice - babyfood 1.000000 1.000 1.000 1100310000 11 Quince 1.000000 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 - b abyfood 2.500000 1.000 1.000 1202013000 12B Apricot, dried 2.500000 8.000 1.000 1202014000 12B Apricot, juice 2.500000 1.000 1.000 1202014001 12B Apricot, juice - babyfood 2.500000 1.000 1.000 1202230000 12B Nectarine 2.500000 1.000 1.000 1202260000 12B Peach 2.500000 1.000 1.000 1202260001 12B Peach - babyfood 2.500000 1.000 1.000 1202261000 12B Peach, dried 2.500000 8.000 1.000 1202261001 12B Peach, dried - babyfood 2.500000 8.000 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 1.000 1.000 1203287001 12C Plum, prune, dried - babyfood 2.500000 1.000 1.00 0 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 2.500000 1.000 1.000 1302057001 13B Blueb erry - babyfood 2.500000 1.000 1.000 1304175000 13D Grape 4.000000 1.000 1.000 1304176000 13D Grape, juice 4.000000 0.200 1.000 1304176001 13D Grape, juice - babyfood 4.000000 0.200 1.000 1304179000 13D Grape, wine and sherry 4.000000 1.000 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 - babyfood 0.030000 1.000 1.000 1400004000 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 1400092000 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 1400282000 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 - babyfood 0.100000 1.000 1.00 0 1500026000 15 Barley, flour 0.100000 1.000 1.000 1500026001 15 Barley, flour - babyfood 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 - 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 1.000Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 15 of 22 1500381000 15 Triticale , flour 0.100000 1.000 1.000 1500381001 15 Triticale, flour - babyfood 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 1.000 1.000 1500402001 15 Wheat, flour - babyfood 0.100000 1.000 1.000 1500403000 15 Wheat, germ 0.100000 1.000 1.000 1500404000 15 Wheat, bran 0.100000 1.000 1.000 2001163000 20A Flax seed, oil 0.100000 1.000 1.000 2001319000 20A Rapeseed, oil 0.100000 1.000 1.000 2001319001 20A Rapesee d, 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 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 1.00 0 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 0.100000 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 1.000 3400291000 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 1.000 1.000 3400293000 34 Pork, fat 0.100000 1.000 1.000 3400293001 34 Pork, f at - babyfood 0.100000 1.000 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 1.000 1.000 3500341000 35 Sheep, fat 0.100000 1.000 1.00 0 3500341001 35 Sheep, fat - babyfood 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 0.015000 1.000 1.000 3600222001 36 Milk, fat - baby food/infant formu 0.015000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.015000 1.000 1.000 3600223001 36 Milk, nonfat solids - baby food/ in 0.015000 1.000 1.000 3600224000 36 Milk, water 0.015000 1.000 1.000 3600224001 36 Milk, water - babyfood/infant form 0.015000 1.000 1.000 3600225001 36 Milk, sugar (lactose) - baby food/ 0.015000 1.000 1.000 7000145000 70 Egg, whole 0.020000 1.000 1.000 7000145001 70 Egg, whole - babyfood 0.020000 1.000 1.000 7000146000 70 Egg, whit e 0.020000 1.000 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 - 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 9500023000 O Banana 0.200000 1.000 1.000 9500023001 O Banana - babyfood 0.200000 1.000 1.000 9500024000 O Banana, dried 0.200000 3.900 1.000 9500024001 O Banana, dried - babyfood 0.200000 3.900 1.000 9500177000 O Grape, leaves 4.000000 1.000 1.000 9500178000 O Grape, raisin 6.000000 1.000 1.000 9500215000 O Mango 0.070000 1.000 1.000 9500215001 O Mango - babyfood 0.070000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 16 of 22 9500216000 O Mango, dried 0.070000 1.000 1.000 9500217000 O Mango, juice 0.070000 1.000 1.000 9500217001 O Mango, juice - babyfood 0.070000 1.000 1.00 0 9500245000 O Papaya 0.300000 1.000 1.000 9500245001 O Papaya - babyfood 0.300000 1.000 1.000 9500246000 O Papaya, dried 0.300000 1.800 1.000 9500247000 O Papay a, juice 0.300000 1.500 1.000 9500283000 O Plantain 0.200000 1.000 1.000 9500284000 O Plantain, dried 0.200000 3.900 1.000



### Attachment 2 **: DEEM -**  **FCID**  **Acute Exposure Estimates** US EPA Ver. 3.18, 03 - 08 - d DEEM - FCID ACUTE Analysis for DIFENOCONAZOLE NHANES 2003 - 2008 2 - Day Residue file: 128847 Acute Aug 2013.R08 Adjustment fac tor #2 used. Analysis Date: 08 - 13 - 2014/11:09:38 Residue file dated: 09 - 25 - 2013/08:12:04 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 Populat ion: 0.028053 11.22 0.058998 23.60 0.126523 50.61 All Infants: 0.056908 22.76 0.086683 34.67 0.238437 95.37 Children 1 - 2: 0.071431 28.57 0.113369 45.35 0.276000 110.40 Children 3 - 5: 0.050407 20.16 0.075530 30.21 0.212138 84.86 Children 6 - 12: 0.033218 13.29 0.058711 23.48 0.1 39789 55.92 Youth 13 - 19: 0.017774 7.11 0.033809 13.52 0.114904 45.96 Adults 20 - 49: 0.020285 8.11 0.040753 16.30 0.103165 41.27 Adults 50 - 99: 0.023527 9.41 0.052000 20.80 0.125606 50.24 Female 13 - 49: 0.020231 8.09 0.040542 16.22 0.103405 41.36Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 17 of 22 **Attachment 3 : DEEM** **- FCID**   **Chronic Residue File** Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DE EM Files \ 128847 Difenoconazole \ Petition 2F8134 Oilseeds 20A \ 128847Chronic Aug 2013 AVG FT WHEAT BARLEY AT TOLERANCE.R08 Chemical: Difenoconazole RfD(Chronic): .01 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .25 mg/kg bw/day NOEL(Acute): 0 mg/ kg bw/day Date created/last modified: 08 - 22 - 2013/07:59:00 Program ver. 3.16, 03 - 08 - d

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101052000 1A Beet, sugar 0.300000 1.000 1.000 0101052001 1A Beet, sugar - babyfood 0.300000 1.000 1.000 0101053000 1A Beet, sugar, molasses 0.300000 0.600 1.000 0101053001 1A Beet, sugar, molasses - babyfood 0.300000 0.600 1.000 0101078000 1AB Carrot 0.062000 1.000 1.000 0101078001 1AB Carrot - babyfood 0.062000 1.000 1.000 0101079000 1AB Carrot, juice 0.062000 1 .000 1.000 0103015000 1CD Arrowroot, flour 1.360000 1.000 1.000 0103015001 1CD Arrowroot, flour - babyfood 1.360000 1.000 1.000 0103017000 1CD Artichoke, Jerusalem 1.360000 1.000 1.000 0103082000 1CD Cassava 1.360000 1.000 1.000 0103082001 1CD Cassava - babyfood 1.360000 1.000 1.000 0103139000 1CD Dasheen, corm 1.360000 1.000 1.000 0103166000 1CD Ginger 1.360000 1.000 1.000 0103166001 1CD Ginger - babyfood 1.360000 1.000 1.000 0103167000 1CD Ginger, dried 1.360000 1.000 1.000 0103296000 1C Potato, chips 1.360000 0.500 1.000 0103297000 1C Potato, dry (granules/ flakes) 1.360000 0.500 1.000 0103297001 1C Potato, dry (granules/ flakes) - b 1.360000 0.500 1.000 0103298000 1C Potato, flour 1.360000 0.500 1.000 010329800 1 1C Potato, flour - babyfood 1.360000 0.500 1.000 0103299000 1C Potato, tuber, w/peel 1.360000 1.000 1.000 0103299001 1C Potato, tuber, w/peel - babyfood 1.360000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 1.360000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel - babyfood 1.360000 1.000 1.000 0103366000 1CD Sweet potato 1.360000 1.000 1.000 0103366001 1CD Sweet potato - babyfood 1.360000 1.000 1.000 0103371000 1CD Tanier, corm 1.360000 1.000 1.000 0103387000 1CD Turmeric 1.360000 1.000 1.000 0103406000 1CD Yam, true 1.360000 1.000 1.000 0103407000 1CD Yam bean 1.360000 1.000 1.000 0301165000 3A Garlic, bulb 0.200000 1.000 1.000 0301165001 3A Garlic, bulb - babyfood 0.200000 1.000 1.000 0301237000 3A Onion, bulb 0.200000 1.000 1.000 0301237001 3A Onion, bulb - babyfood 0.200000 1.000 1.000 0301238000 3A Onion, bulb, dried 0.200000 9.000 1.000 0301238001 3A Onion, bulb, dried - babyfood 0.200000 9.000 1.000 0301338000 3A Shallot, bulb 0.200000 1.000 1.000 0302103000 3B Chive, fresh leaves 6.000000 1.000 1.000 0302198000 3B Leek 6.000000 1.000 1.000 0302239000 3B Onion, green 6.000000 1.000 1.000 0302338500 3B Shallot, fresh leaves 6.000000 1.000 1.000 0501061000 5A Broccoli 0.221000 1.000 1.000 0501061001 5A Broccoli - babyfood 0.221000 1.000 1.000 0501062000 5A Broccoli, Chinese 0.221000 1.000 1.000 0501064000 5A Brussels sprouts 0.029000 1.000 1.00 0 0501069000 5A Cabbage 0.029000 1.000 1.000 0501071000 5A Cabbage, Chinese, napa 0.029000 1.000 1.000 0501072000 5A Cabbage, Chinese, mustard 0.221000 1.000 1.000 0501083000 5A Cauli flower 0.221000 1.000 1.000 0501196000 5A Kohlrabi 0.029000 1.000 1.000 0502063000 5B Broccoli raab 5.100000 1.000 1.000 0502070000 5B Cabbage, Chinese, bok choy 5.100000 1.000 1.000 0502117000 5B Collards 5.100000 1.000 1.000 0502194000 5B Kale 5.100000 1.000 1.000 0502229000 5B Mustard greens 5.100000 1.000 1.000 0502318000 5B Rape greens 5.100000 1.000 1.000 0502389000 5B Turnip, greens 5.100000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 18 of 22 0600347000 6 Soybean, seed 0.021500 1.000 1.000 0600349000 6 Soybean, soy milk 0.021500 1.000 1.000 0600349001 6 Soybean, soy milk - babyfood or in 0.021500 1.000 1.000 0600350000 6 Soybean, oil 0.021500 1.000 1.000 0600350001 6 Soybean, oil - babyfood 0.021500 1.000 1.000 0601349500 6AB Soybean, vegetable 0.021500 1.000 1.000 0603098000 6C Chickpea, seed 0.017000 1.000 1.000 0603098001 6C Chickpea, seed - babyfood 0.017000 1.000 1.000 0603099000 6C Chickpea, flour 0.017000 1.000 1.000 0603348000 6C Soybean, flour 0.021500 1.000 1.000 0603348001 6C Soybean , flour - babyfood 0.021500 1.000 1.000 0801374000 8A Tomatillo 0.165000 1.000 1.000 0801375000 8A Tomato 0.165000 1.000 1.000 0801375001 8A Tomato - babyfood 0.165000 1.000 1.000 0801376000 8A Tomato, paste 0.165000 1.600 1.000 0801376001 8A Tomato, paste - babyfood 0.165000 1.600 1.000 0801377000 8A Tomato, puree 0.165000 0.500 1.00 0 0801377001 8A Tomato, puree - babyfood 0.165000 0.500 1.000 0801378000 8A Tomato, dried 0.165000 14.300 1.000 0801378001 8A Tomato, dried - babyfood 0.165000 14.300 1.000 0801379000 8A Tomat o, juice 0.165000 1.500 1.000 0802148000 8BC Eggplant 0.133000 1.000 1.000 0802234000 8BC Okra 0.600000 1.000 1.000 0802270000 8B Pepper, bell 0.133000 1.000 1.000 0802270001 8B Pepper, bell - babyfood 0.133000 1.000 1.000 0802271000 8B Pepper, bell, dried 0.133000 1.000 1.000 0802271001 8B Pepper, bell, dried - babyfood 0.133000 1.000 1.000 0802272000 8BC Pepper, nonbell 0.133000 1.000 1.000 0802272001 8BC Pepper, nonbell - babyfood 0.133000 1.000 1.000 0802273000 8BC Pepper, n onbell, dried 0.133000 1.000 1.000 0901075000 9A Cantaloupe 0.137000 1.000 1.000 0901187000 9A Honeydew melon 0.137000 1.000 1.000 0901399000 9A Watermelon 0.137000 1.000 1.000 0901400000 9A Watermelon, juice 0.137000 1.000 1.000 0902021000 9B Balsam pear 0.055000 1.000 1.000 0902088000 9B Chayote, fruit 0.310000 1.000 1.000 0902102000 9B Chinese waxgourd 0.055000 1.000 1.000 0902135000 9B Cucumber 0.055000 1.000 1.000 0902308000 9B Pumpkin 0.031000 1.000 1.000 0902309000 9B Pumpkin , seed 0.031000 1.000 1.000 0902356000 9B Squash, summer 0.031000 1.000 1.000 0902356001 9B Squash, summer - babyfood 0.031000 1.000 1.000 0902357000 9B Squash, winter 0.031000 1.000 1.000 0902357001 9B Squash, winter - babyfood 0.031000 1.000 1.000 1001106000 10A Citron 0.208000 1.000 1.000 1001107000 10A Citrus hybrids 0.208000 1.000 1.00 0 1001108000 10A Citrus, oil 25.000000 1.000 1.000 1001240000 10A Orange 0.208000 1.000 1.000 1001241000 10A Orange, juice 0.208000 0.100 1.000 1001241001 10A Orang e, juice - babyfood 0.208000 0.100 1.000 1001242000 10A Orange, peel 0.208000 1.000 1.000 1001369000 10A Tangerine 0.208000 1.000 1.000 1001370000 10A Tangerine, juice 0.208000 0.100 1.000 1002197000 10B Kumquat 0.208000 1.000 1.000 1002199000 10B Lemon 0.176000 1.000 1.000 1002200000 10B Lemon, juice 0.176000 0.100 1.000 1002200001 10B Lemon, juice - babyfood 0.176000 0.100 1.000 1002201000 10B Lemon, peel 0.176000 1.000 1.000 1002206000 10B Lime 0.176000 1.000 1.000 1002207000 10B Lime, juice 0.176000 0.100 1.000 1002207001 10B Lime, juice - babyfood 0.176000 0.100 1.000 1003180000 10C Grapefruit 0.120000 1.000 1.000 1003181000 10C Grapefruit, juice 0.120000 0.100 1.000 1003307000 10C Pummelo 0.120000 1.000 1.000 1100007000 11 Apple, fruit with peel 0.203000 1.000 1.000 1100008000 11 Apple, peeled fruit 0.203000 1.000 1.000 1100008001 11 Apple, peeled fruit - babyfood 0.203000 1.000 1.000 1100009000 11 Apple, dried 0.203000 8.000 1.000 1100009001 11 Apple, dried - babyfood 0.203000 8.000 1.000 1100010000 11 Apple, juice 0.203000 0.040 1.000 1100010001 11 Apple, juice - babyfood 0.203000 0.040 1.000 1100011000 11 Apple, sauce 0.203000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 19 of 22 1100011001 11 Apple, sauce - babyfood 0.203000 1.000 1.000 1100129000 11 Crabapple 0.203000 1.000 1.000 1100173500 11 Goji berry 0.123000 1.000 1.00 0 1100210000 11 Loquat 0.123000 1.000 1.000 1100266000 11 Pear 0.123000 1.000 1.000 1100266001 11 Pear - babyfood 0.123000 1.000 1.000 1100267000 11 Pear, dried 0.123000 6.250 1.000 1100268000 11 Pear, juice 0.123000 1.000 1.000 1100268001 11 Pear, juice - babyfood 0.123000 1.000 1.000 1100310000 11 Quince 0.123000 1.000 1.000 1201090000 12A Cherry 0.622000 1.000 1.000 1201090001 12A Cherry - babyfood 0.622000 1.000 1.000 1201091000 12A Cherry, juice 0.622000 1.500 1.000 1201091001 12A Cherry, juice - babyfood 0.622000 1.500 1.000 1202012000 12B Apricot 0.421000 1.000 1.000 1202012001 12B Apricot - b abyfood 0.421000 1.000 1.000 1202013000 12B Apricot, dried 0.421000 8.000 1.000 1202014000 12B Apricot, juice 0.421000 1.000 1.000 1202014001 12B Apricot, juice - babyfood 0.421000 1.000 1.000 1202230000 12B Nectarine 0.421000 1.000 1.000 1202260000 12B Peach 0.421000 1.000 1.000 1202260001 12B Peach - babyfood 0.421000 1.000 1.000 1202261000 12B Peach, dried 0.421000 8.000 1.000 1202261001 12B Peach, dried - babyfood 0.421000 8.000 1.000 1202262000 12B Peach, juice 0.421000 1.000 1.000 1202262001 12B Peach, juice - babyfood 0.421000 1.000 1.000 1203285000 12C Plum 0.295000 1.000 1.000 1203285001 12C Plum - babyfood 0.295000 1.000 1.000 1203286000 12C Plum, prune, fresh 0.295000 1.000 1.000 1203286001 12C Plum, prune, fresh - babyfood 0.295000 1.000 1.000 1203287000 12C Plum, prune, dried 0.295000 2.600 1.000 1203287001 12C Plum, prune, dried - babyfood 0.295000 2.600 1.00 0 1203288000 12C Plum, prune, juice 0.295000 1.400 1.000 1203288001 12C Plum, prune, juice - babyfood 0.295000 1.400 1.000 1302057000 13B Blueberry 0.495000 1.000 1.000 1302057001 13B Blueb erry - babyfood 0.495000 1.000 1.000 1304175000 13D Grape 0.613000 1.000 1.000 1304176000 13D Grape, juice 0.613000 0.200 1.000 1304176001 13D Grape, juice - babyfood 0.613000 0.200 1.000 1304179000 13D Grape, wine and sherry 0.613000 1.000 1.000 1307359000 13G Strawberry 0.495000 1.000 1.000 1307359001 13G Strawberry - babyfood 0.495000 1.000 1.000 1307360000 13G Strawberry, juice 0.495000 1.000 1.000 1307360001 13G Strawberry, juice - babyfood 0.495000 1.000 1.000 1400003000 14 Almond 0.005000 1.000 1.000 1400003001 14 Almond - babyfood 0.005000 1.000 1.000 1400004000 14 Almond, oil 0.005000 1.000 1.000 1400004001 14 Almond, oil - babyfood 0.005000 1.000 1.000 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 1.000 1400282000 14 Pistachio 0.005000 1.000 1.000 1400391000 14 Walnut 0.007000 1.000 1.000 1500025000 15 Barley, pearled barley 0.100000 1.000 1.000 1500025001 15 Barley, pearled barley - babyfood 0.100000 1.000 1.00 0 1500026000 15 Barley, flour 0.100000 1.000 1.000 1500026001 15 Barley, flour - babyfood 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 - 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 1.000Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 20 of 22 1500329000 15 Rye, flour 0.010000 1.000 1.000 1500381000 15 Triticale , flour 0.100000 1.000 1.000 1500381001 15 Triticale, flour - babyfood 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 1.000 1.000 1500402001 15 Wheat, flour - babyfood 0.100000 1.000 1.000 1500403000 15 Wheat, germ 0.100000 1.000 1.000 1500404000 15 Wheat, bran 0.100000 1.000 1.000 2001163000 20A Flax seed, oil 0.100000 1.000 1.000 2001319000 20A Rapeseed, oil 0.100000 1.000 1.000 2001319001 20A Rapesee d, 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 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 1.00 0 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 0.100000 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 1.000 3400291000 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 1.000 1.000 3400293000 34 Pork, fat 0.100000 1.000 1.000 3400293001 34 Pork, f at - babyfood 0.100000 1.000 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 1.000 1.000 3500341000 35 Sheep, fat 0.100000 1.000 1.00 0 3500341001 35 Sheep, fat - babyfood 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 0.015000 1.000 1.000 3600222001 36 Milk, fat - baby food/infant formu 0.015000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.015000 1.000 1.000 3600223001 36 Milk, nonfat solids - baby food/ in 0.015000 1.000 1.000 3600224000 36 Milk, water 0.015000 1.000 1.000 3600224001 36 Milk, water - babyfood/infant form 0.015000 1.000 1.000 3600225001 36 Milk, sugar (lactose) - baby food/ 0.015000 1.000 1.000 7000145000 70 Egg, whole 0.020000 1.000 1.000 7000145001 70 Egg, whole - babyfood 0.020000 1.000 1.000 7000146000 70 Egg, whit e 0.020000 1.000 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 - babyfood 0.020000 1.000 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 9500023000 O Banana 0.200000 1.000 1.000 9500023001 O Banana - babyfood 0.200000 1.000 1.000 9500024000 O Banana, dried 0.200000 3.900 1.000 9500024001 O Banana, dried - babyfood 0.200000 3.900 1.000 9500177000 O Grape, leaves 0.613000 1.000 1.000 9500178000 O Grape, raisin 0.613000 3.500 1.000 9500215000 O Mango 0.070000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 21 of 22 9500215001 O Mango - babyfood 0.070000 1.000 1.000 9500216000 O Mango, dried 0.070000 1.000 1.000 9500217000 O Mango, juice 0.070000 1.000 1.000 9500217001 O Mango, juice - babyfood 0.070000 1.000 1.00 0 9500245000 O Papaya 0.300000 1.000 1.000 9500245001 O Papaya - babyfood 0.300000 1.000 1.000 9500246000 O Papaya, dried 0.300000 1.800 1.000 9500247000 O Papay a, juice 0.300000 1.500 1.000 9500283000 O Plantain 0.200000 1.000 1.000 9500284000 O Plantain, dried 0.200000 3.900 1.000Difenoconazole Dietary Exposure Assessment DP#: 412812 & 422170

PC Code: 128847



### 22 of 22 **Attachm ent 4**  **: DEEM -**  **FCID**  **Chronic Exposure Estimates** US EPA Ver. 3.16, 03 - 08 - d DEEM - FCID Chronic analysis for DIFENOCONAZOLE NHANES 2003 - 2008 2 - day Residue file name: C: \ Users \ tmorton \ Documents \ My Files \ DEEM Files \ 128847 Difenoconazole \ Petition 2F8134 Oilseeds 20A and Dragonfruit \ 128847Chronic Aug 2013 AVG FT WHEAT BARLEY AT TOLERANCE.R08 Adjustment factor #2 used. Analysis Date 08 - 13 - 2014/11:10:27 Resid ue file dated: 09 - 25 - 2013/08:11:21 Reference dose (RfD, Chronic) = .01 mg/kg bw/day

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

---------------------------------- --------------------------------------------- Total Exposure

----------------------------------- Population mg/kg Pe rcent of Subgroup body wt/day Rfd

-------------------------------------- ------------- ---------------- Total US Population 0.002685 26.9% Hispanic 0.002695 26.9% Non - Hisp - White 0.002650 26.5% Non - Hisp - Black 0.002711 27.1% Non - Hisp - Other 0.003 075 30.8% Nursing Infants 0.002931 29.3% Non - Nursing Infants 0.005629 56.3% Female 13+ PREG 0.002420 24.2% Children 1 - 6 0.006387 63.9% Children 7 - 12 0.003360 33.6% Male 13 - 19 0.002154 21.5% Female 13 - 19/NP 0.001991 19.9% Male 20+ 0.002238 22.4% Female 20+/NP 0.002213 22.1% Seniors 55+ 0.002359 23.6% All Infants 0.004796 48.0% Female 13 - 50 0.002090 20.9% Children 1 - 2 0.007816 78.2% Children 3 - 5 0.005781 57.8% Children 6 - 12 0.003616 36.2% Youth 13 - 19 0.002069 20.7% Adults 20 - 49 0.002144 21. 4% Adults 50 - 99 0.002348 23.5% Female 13 - 49 0.002092 20.9%

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