Difenoconazole Dietary Exposure Assessment DP#: 389652

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: 26 - October - 20 1 1 Subject: **Difenoconazole.** Acute and Chronic Aggregate Dietary Exposure and Risk Assessments fo r the Amended Section 3 Registration to Add Seed Treatment Uses on Oats and Rye . PC Code: 128847 DP Barcode: 389652 Decision No.: 440121 Registration No. : None Petition Nos.: 0 F7 785 Regulatory Action: Amended Section 3 Assessment Type: Singl e 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: Dennis McNeilly Ch emist

David Hrdy , Senior Scientist Dietary Exposure Science Advisory Council (DESAC) And Susan V. Hummel, Senior Chemist RABIV/HED (7509P) To: Rebecca Daiss , Risk Assessor

RABIV/HED (7509 P ) And Elissa Reaves, Branch Chief RABIV/HED (7509P) An d Tony Kish F ungicide B ranch/RD (7505P)Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 2 of 22 **Executive Summary** Aggregate (food + water) a cute and chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM - FCID  , ver. 2.03 ) . This m odel uses food consumption data from the United States Department of Agriculture’s (USDA’s) Continuing Survey s of Food Intakes by Individuals (CSFI I; 1994 - 1996 and 1998). The analy ses were performed to support an amended Section 3 registration to add seed treatment uses on oats and rye 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]. The unrefined acute analy s i s assumed tolerance - level residues , maximum expected residues for wheat grain and barley

grain from field trials with a lower method limit of quantitation (L OQ) , 100% crop treated (CT), and the available empirical or DEEM  (ver. 7. 81 ) default processing factors. The EDWC of 15.8 μg/L (ppb) was used for the acute dietary exposure analysis and an EDWC of 10.4 μg/L(ppb) was used for the chronic dietary exposure analysis. The resulting acute food plus water exposure estimates were less than HED’s level of concern ( - <100 % of the acut e population - adjusted dose (aPAD)) at the 95 th 

### percentile of the exposure distribution for the general U . S . population ( 8 % aPAD) and all population sub - groups; the most highly exposed population subgroup was c hildren 1 - 2 ye ar s old with 1 9 % aPAD. The so mewhat 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 resulting chron ic 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 ( 1 8 % cPAD) and all population sub groups; the most highly

exposed population subgroup was c hildren 1 - 2 years old with 4 6 % cPAD. **The requested amended**  **uses of difenoconazole**  **did not result in**  **an increase**  **in dietary**  **exposure estimate s**  **for free triazole or conjugated triazoles. Therefore, the last dietary exposure analyses for the triazole m**  **etabolites ( D388469,**  **T .**  **Morton ,**  **2 7**  **Apr . 20**  **11 )**  **will not need to be updated**  **and still applies** . **I. Introduction** 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.) d ivided by the required uncertainty

or safety factors. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generally concerned when estimated cancer risk exceeds one in one million. Ref

erences which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing ExposureDifenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 3 of 22 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 ( 3 - March - 20 1 1 ; DP# 3 7 89 38 ). **II. Residue Information** Difenoconazole tolerances are published in 40 CFR§180.475. Residues of Concern in Plants and Livestock: The HED Metabolism Assessment Review Committee (MARC) has determined that for tolerance expression and risk assessme nt purposes, the residue of concern is difenoconazole per se for plant and livestock commodities. The MARC, however, stated that if tolerances are proposed for difenoconazole resulting from foliar uses which result in higher residue levels of CGA - 205375 than parent, then the need to include CGA - 205375 should be reconsidered (Memo, G. Kramer, 22 - JUL - 1994; No DP#) . Because the petitioner has now proposed foliar uses of difenoconazole, which result in higher residues in crop commodities , the need to include metabolite CGA 205375 in the tolerance expression and/or risk assessment has been re - examined . Based upon a review of the previously- submitted metabolism data for difenoconazole, HED concludes the residue of concern for both tolerance setting and risk ass essment for the crops included in this petition is difenoconazole . However, HED concludes the residue of concern in livestock for tolerance setting and risk assessment are difenoconazole and its metabolite CGA 205375 (for more details, see the summary doc ument, DP# 340379). T able 1 below summarizes tolerance expression and the residues of concern in plant and livestock commodities. **Table 1 .**  **Difenoconazole Residues of Concern in Plants and Rum inants.** 

**Matrix Residues of Concern**  **For Risk Assessm en**  **t For Tolerance Expression**  Plants Primary and Rotational crops Parent Only Parent Only Livestock Ruminant and Poultry Parent and CGA 205375 Parent and CGA 205375 Drinking Water Parent Only NA 

### No new residue data was submitted to support an ame nded Section 3 registration to add seed treatment uses on oats and rye. These amended uses are covered by previously

submitted residue data. The amended uses of difenoconazole do not increase the livestock dietary burden and does not affect the livestock tolerances. Previously Recommended Tolerances : Based on the residue chemistry data submitted with the previous petitions, HED recommended for establishment of the new food toleranc es (DP# 36 6507 , B . Cropp - Ko h lligian , 2 3 - Feb - 20 1 1 ). The newly recommended , established, and revised tolerances are listed in Table 2 below.Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 4 of 22 **Table 2 . Tolerance Sum**  **ma ry for Difenoconazole**  **(non feed item s)**  **.** Commodity Existing/Established Tolerances (ppm) New Tolerances (ppm) 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 0.01 ------ Beet, sugar 0.30 ------ Papaya 0.30 ------ Banana 0.2 - ----- Barley, grain 0.1 **0. 10**  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 ------ Horse, fat 0.10 ------ Horse, meat 0.05 ------ Horse, meat byproducts (except 0. 10 ------Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 5 of 22 **Table 2 . Tolerance Sum**  **ma ry for Difenoconazole**  **(non feed item s)**  **.** Commodity Existing/Established Tolerances (ppm) New Tolerances (ppm) liver) Horse, liver 0. 4 0 ------ Milk 0.01 ------ Rye, grain 0.1 **0.01** Sheep, fat 0. 10 ------ Sheep, meat 0.05 ------ Sheep, meat byproducts (excep t liver) 0. 10 ------ Sheep, liver 0. 40 ------ Wheat, grain 0.1 **0. 10**  Wax apple 0.07 ------ Mango 0.07 ------ Carrot ------ 0.50 Chickpea ------ 0.08 Soybean, seed ------ 0.15 Fruit, stone, group 12 ------ 2.5 Straw berry ------ 2.5 Turnip greens -- ---- 35 Oat, grain ------ **0.01** 

### The requested **amended uses of**  **difenoconazole did not**  **result in an**  **increase in**  **dietary exposure estimate**  **s for free triazole or conjugated triazoles. Therefore, the last dietary**  **exposure analyses for the triazole metabolite s (** **D388469, T**  **. Morton**  **, 27**  **Apr . 20**  **11 )**  **will not need to be updated**  .Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 6 of 22 Food Residues and processing factors used in the Acute and Chronic Analysis : The acute analy s i s assumed tolerance - level residues , maximum expected residues for wheat grain and barley grain from field trials with a lower method L OQ, 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 analysis as sumed tolerance - level resi dues for some commodities, average field trial residues for the majority of commodities, and 100 % CT . Those commodities where field trial data were used are summarized below. HED SOP 2000.1 Guidance for Translation of Field Trial Data from Representativ e Commodities in the Crop Group Regulation to Other Commodities in Each Crop Group/Subgroup dated 9/12/2000 was used in translating to other commodities in the crop group. Experimental processing factors were used for apple juice (0.04x), grape juice (0.2 x), citrus juices (0.1x), potato chips (0.5x), potato granules/flakes (0.5x), raisin (3.5x chronic only since raisin tolerance used in acute ), sugar beet molasses (0.6x), tomato paste (1.6x), and tomato puree (0.5x); DEEM  (ver. 7. 81 ) default process ing fa ctors were assumed for other processed commodities. Almond : Field trial residues were used from MRID 47586101. Apple : Field trial residues were used from MRID 46950233. Broccoli : Field trial residues were used from MRID 47586102. Residues from 1 - 7 day PHIwere 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 PHI s. 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 479298 04. Chickpea : Field trial residues were used from MRID 47929805. Cucumber : Field trial residues were used from MRID 47586103. Residues 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. Li me : 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 PHIwere used since registered labels allow from 1 - 7 day PHI s.Difenoconazole Dietary Exposure Assessment DP#: 389652

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### 7 of 22 Orange : Field trial residues were used from MRID 47586104. Pear : Field trial residues were used from MRID 46950233. Pecan : Field tria l residues were used from MRID 47586106. Peppers : Field trial residues were used from MRID 46950234. Potato : Field trial residues were used from MRID 46950235. Soy bean : Field trial residues were used from MRID 47929801. Stone Fruit : Field trial residue s were used from MRID 47929803. Strawberry : Field trial residues were used from MRID 47929802. Sugar Beet : Field trial residues were used from MRID 46950236. Summer Squash : Field trial residues were used from MRID 47586103. Residues from 0 - 1 day PHIwe re used since registered labels allow from 0 - 1 day PHI s . Tomato : Field trial residues were used from MRIDs 46950234, 47417705, and 47417708. **III. Drinking Water Data**  The drinking water estimates used in the dietary risk assessment were provided by the Envi ronmental Fate and Effects Division (EFED; Memo, I . Maher, 1 - June - 2010; D371044). EFED conducted a Tier II drinking water assessment for surface water sources using the Pesticide Root Zone/Exposure Analysis Modeling Sy stem (PRZM/EXAMS ) for the registered and proposed new uses. Among all the registered and proposed new uses, the highest estimated drinking water concentrations (EDWCs) f or surface water sources were derived for aerial applications of difenoconazole to New York grapes at the maximum annual ap plicati on rate of 0.46 lb ai/acre. The estimated drinking water residues for 1 - in - 10 year annual peak, 1 - in - 10 year annual mean, and 36 - ye ar annual mean are 15.8, 10.4, and 7.62 μg/L (ppb) respectively . The highest SCI - GROW estimated drinking water conc entration of difenoconazole from sh allow ground water sources is 1.28 x 10 - 2 

### μg/L , obtained for the maximum application rate for ornamentals (0.52 lb ai/A; D333319 ) . These concentrations can be considered as both the acute and chronic groundwater values. The EDWCs from ground water sources are expected to be the same for the proposed golf course turf uses as estimated for ornamentals. The 1 - in - 10 year annual peak EDWC of 15.8 μg/L (ppb) was used for the acute dietary (food plus water) exposure analy sis and the 1 - in - 10 year annual mean EDWC of 10.4 μg/L (ppb) was used for the chronic dietary (food plus water) exposure analy sis.Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 8 of 22 **I V**  **. DEEM**  **- FCID**   **Program and Consumption Informat**  **ion** Difenoconazole acute and chronic dietary exposure assessments were conducted using the DEEM - FCID  (ver. 2.03), which incorporates consumption data from USDA’s CSFII (1994 - 1996 and 1998). The 1994 - 96, 98 data are based on the reported consumption of m ore than 20,000 individuals over two non - consecutive survey day s. 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) usi ng 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 reta ined as individual consumption events. Based on analysis of the 1994 - 96, 98 CSFI I 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 (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ years old. For chronic dietary

exposure assessment, an estimate of the residue level in eac h food or food form ( e .g. , orange or orange juice) on the food commodity residue list is multiplied by the average daily

consumption estimate for that food/food form. The resulting residue consumption estimate for each food/food form is summed with the re sidue 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 p opulation 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 obt ain 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 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.Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 9 of 22 **V. Toxicological Information** On 08 - SEP - 1998, HED’s Hazard I dentification Assessment Review Committee (HIARC) evaluated the toxicology

database of difenoconazole and re - assessed the RfD established in 1994, as well as the toxicological endpoints for the dietary and occupational exposure risk assessments th at 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 t eam 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. Inaccordance with HED’s current policy and EPA’s 2005 Cancer Guidelines, difenoconazole is classified as “Suggestive Evidence of Carcinogenic 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. 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 a ssessment i s not being conducted for difenoconazole. **Table 3. Sum ma**  **ry 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** Acute 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 **Com bined chronic**  **toxicity/carcinogenicity (rat; dietary)**  LOAEL = 24.1 /32.8 mg/kg/day (M/F) based on cumulati ve decreases in body - we ight 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 Marc h 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 observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human ( int er 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.Difenoconazole Dietary Exposure Assessment DP#: 389652

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### 10 of 22 **V I**  **. 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. 2.03) acute and chronic exposure analyses. Acute and chronic a ggregate (food + water) analy ses were performed using DEEM - FCID  estimat ing 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 . Th e 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 ( 8 % aPAD) and all population sub - groups; the most highly exposed population subgrou p was Children 1 - 2 ye ars old with 1 9 % aPAD. The resulting chronic food exposure estimates were less than HED’s level of concern ( <100 % cPAD) for the general U . S . population (1 7 % cPAD) and all population sub - groups; the most highly exposed population subgroup was children 1 - 2 years old with 4 6 % 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. Population Subgroup**  **aPAD (m g/kg/day)**  **Exposure (m g/kg/day)**  **% a**  **PAD** General U.S. Populati on

0.25 0.0 20 538 8 All Infants (< 1 year old) 0. 03 9780 1 6 **Children 1 -**  **2 years old 0.**  **04 7**  **638 1**  **9** Children 3 - 5 years old 0.0 3 7 050 1 5 Children 6 - 12 years old 0.0 21 576 9 Youth 13 - 19 years old 0.0 11 240 5 Adults 20 - 49 years old 0.0 1 4 6 99 6 Adults 50+ years old 0.0 1 9 351 8 Females 13 - 49 years old 0.0 1 5 084 6 The bolded %aPAD is the highest.Difenoconazole Dietary Exposure Assessment DP#: 389652

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### 11 of 22 **Table 5**  **. Summary of Chronic Dietary**  **(Food plus Water) Exposure and Risk for Difenoconazole.**  **Population Subgroup cPAD (m**  **g/k g/day)**  **Exposure (m g/kg/day)**  **%cPAD** General U.S. Population

0.01 0.001 687 1 7 All Infants (< 1 year old) 0.00 30 01 3 0 **Children 1 -**  **2 years old 0.00**  **4 573**  **4 6**  Children 3 - 5 years old 0.00 3 607 3 6 Children 6 - 12 years old 0.00 2 027 2 0 Youth 1 3 - 19 years old 0.001 30 7 1 3 Adults 20 - 49 years old 0.001 317 1 3 Adults 50+ years old 0.001 562 1 6 Females 13 - 49 years old 0.001 37 3 1 4 The bolded %cPAD is the highest. 

### VI **I . Characterization of Inputs/Outputs**  The acute analy s i s assumed tolerance - level residues, maximum expected residues for wheat grain and barley

grain from field trials with a lower method L OQ, 100% CT, and empirical or DEEM  default processing factors . The chronic analysis 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 analyses are considered conservative . While they could be significantly

refined, further refinement is n ot warranted as estimated risks are not of concern. **VII I**  **. Conclusions** An a cute aggregate (food + water) dietary risk assessment was conducted for difenoconazole using the DEEM - FCID  (ver. 2.03) M odel and assumed tolerance - level residues, maximum expe cted residues for wheat grain and barley grain from field trials with a lower method L OQ , 100% CT, and empirical or DEEM  default processing factors . The chronic aggregate dietary risk assessment assumed tolerance - level residues for some commodities, ave rage 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 8 % and 1 7 %, respectively . The most highly- exposed population subgroups in the acute ( at the 95 th 

### percentile of the exposure distribution) and chronic analyses were Children 1 - 2 ye ar s old ( 1 9 % aPAD) and children 1 - 2 years old ( 4 6 % cPAD) , respectively .Difenoconazole Dietary Exposure Assessment DP#: 389652

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### 12 of 22 **IX . 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 a ll attachments: T . Morton (RAB IV ) RDI: D. McNeilly and D. Hrdy - DESAC ( 26 - October - 20 1 1 ) ; S. Hummel ( 26 - October - 201 1 ) Petition Number(s): 0 F7 785 DP#: 389652 PC Code: 128847 T . Morton :S10 838 :PY1:(703)305 - 6691Difenoconazole Dietary Exposure Assessment DP#: 389652

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### 13 of 22 **Attachment 1 : DEEM**  **- FCID**   **Acute Residue File** Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 128847 Difenoconazole 0F7785 May 2011 \ difenoconazole_acute - 05 - 11.R98 Chemical: Difenoconazole RfD(Chronic): .01 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .25 mg/kg b w/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 05 - 10 - 2011/07:02:12/8 Program ver. 2.03

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 01010520 1A Beet, sugar 0.300000 1.000 1.000 010105 21 1A Beet, sugar - babyfood 0.300000 1.000 1.000 01010530 1A Beet, sugar, molasses 0.300000 0.600 1.000 01010531 1A Beet, sugar, molasses - babyfood 0.300000 0.600 1.000 01010780 1AB Carrot 0.500000 1.000 1.000 01010781 1AB Carrot - babyfood 0.500000 1.000 1.000 01010790 1AB Carrot, juice 0.500000 1.000 1.000 01032960 1C Potato, chips 0.010000 0.500 1 .000 01032970 1C Potato, dry (granules/ flakes) 0.010000 0.500 1.000 01032971 1C Potato, dry (granules/ flakes) - b 0.010000 0.500 1.000 01032980 1C Potato, flour 0.010000 0.500 1.000 01032981 1C Potato, fl our - babyfood 0.010000 0.500 1.000 01032990 1C Potato, tuber, w/peel 0.010000 1.000 1.000 01032991 1C Potato, tuber, w/peel - babyfood 0.010000 1.000 1.000 01033000 1C Potato, tuber, w/o peel 0.0100 00 1.000 1.000 01033001 1C Potato, tuber, w/o peel - babyfood 0.010000 1.000 1.000 03001640 3 Garlic 0.200000 1.000 1.000 03001650 3 Garlic, dried 0.200000 1.000 1.000 03001651 3 Garlic, dried - babyfood 0.200000 1.000 1.000 03001980 3 Leek 6.000000 1.000 1.000 03002370 3 Onion, dry bulb 0.200000 1.000 1.000 03002371 3 Onion, dry bulb - babyfood 0.200000 1.000 1.000 03002380 3 Onion, dry bulb, dried 0.200000 9.000 1.000 03002381 3 Onion, dry bulb, dried - babyfood 0.200000 9.000 1.000 03002390 3 Onion, green 6.000000 1.000 1.000 03003380 3 Shallot 0.200000 1.000 1.000 05010610 5A Broccoli 1.900000 1.000 1.000 05010611 5A Broccoli - babyfood 1.900000 1.000 1.000 05010620 5A Broccoli, Chine se 1.900000 1.000 1.000 05010640 5A Brussels sprouts 1.900000 1.000 1.000 05010690 5A Cabbage 1.900000 1.000 1.000 05010710 5A Cabbage, Chinese, napa 1.900000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 1.900000 1.000 1.000 05010830 5A Cauliflower 1.900000 1.000 1.000 05011960 5A Kohlrabi 1.900000 1.000 1.000 05020630 5B Br occoli raab 35.000000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 35.000000 1.000 1.000 05021170 5B Collards 35.000000 1.000 1.000 05021940 5B Kale 35.000000 1.000 1.000 05022290 5B Mustard greens 35.000000 1.000 1.000 05023180 5B Rape greens 35.000000 1.000 1.000 05023890 5B Turnip, greens 35.000000 1.000 1.000 060 03470 6 Soybean, seed 0.150000 1.000 1.000 06003480 6 Soybean, flour 0.150000 1.000 1.000 06003481 6 Soybean, flour - babyfood 0.150000 1.000 1.000 06003490 6 Soybean, soy milk 0.150000 1.000 1.000 06003491 6 Soybean, soy milk - babyfood or in 0.150000 1.000 1.000 06003500 6 Soybean, oil 0.150000 1.000 1.000 06003501 6 Soybean, oil - babyfood 0.150000 1.000 1.000 06030980 6C Chickpea, seed 0.080000 1.000 1.000 06030981 6C Chickpea, seed - babyfood 0.080000 1.000 1.000 06030990 6C Chickpea, flour 0.080000 1.000 1.000 08001480 8 Eggplan t 0.600000 1.000 1.000 08002340 8 Okra 0.600000 1.000 1.000 08002700 8 Pepper, bell 0.600000 1.000 1.000 08002701 8 Pepper, bell - babyfood 0.6 00000 1.000 1.000 08002710 8 Pepper, bell, dried 0.600000 1.000 1.000 08002711 8 Pepper, bell, dried - babyfood 0.600000 1.000 1.000 08002720 8 Pepper, nonbell 0.600000 1.000 1.000 08002721 8 Pepper, nonbell - babyfood 0.600000 1.000 1.000 08002730 8 Pepper, nonbell, dried 0.600000 1.000 1.000 08003740 8 Tomatillo 0.600000 1.000 1.000 08003750 8 Tomato 0.600000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 14 of 22 08003751 8 Tomato - babyfood 0.600000 1.000 1.000 08003760 8 Tomato, paste 0.600000 1.600 1.000 08003761 8 Tomato, paste - babyfood 0.600000 1.600 1.0 00 08003770 8 Tomato, puree 0.600000 0.500 1.000 08003771 8 Tomato, puree - babyfood 0.600000 0.500 1.000 08003780 8 Tomato, dried 0.600000 14.300 1.000 08003781 8 Tomato, drie d - babyfood 0.600000 14.300 1.000 08003790 8 Tomato, juice 0.600000 1.500 1.000 09010750 9A Cantaloupe 0.700000 1.000 1.000 09010800 9A Casaba 0.700000 1.000 1.000 09011870 9A Honeydew melon 0.700000 1.000 1.000 09013990 9A Watermelon 0.700000 1.000 1.000 09014000 9A Watermelon, juice 0.700000 1.000 1.000 09020210 9B Balsam pear 0.700000 1.000 1.000 09020880 9B Chayote, fruit 0.700000 1.000 1.000 09021020 9B Chinese waxgourd 0.700000 1.000 1.000 09021350 9B Cucumber 0.700000 1.000 1.000 09023080 9B Pumpkin 0.700000 1.000 1.000 09023090 9B Pumpkin, seed 0.700000 1.000 1.000 09023560 9B Squash, summer 0.700000 1.000 1.000 09023561 9B Squash, summer - babyfood 0.700000 1.000 1.000 09023570 9B Squash, winter 0.700000 1.000 1.000 09023571 9B Squash, winter - babyfood 0.700000 1.000 1.000 10001060 10 Citrus citron 0.600000 1.000 1.000 10001070 10 Citrus hybrids 0.600000 1.000 1.000 10001080 10 Citrus, oil 25.000000 1.000 1.000 10001800 10 Grapefruit 0.600000 1. 000 1.000 10001810 10 Grapefruit, juice 0.600000 0.100 1.000 10001970 10 Kumquat 0.600000 1.000 1.000 10001990 10 Lemon 0.600000 1.000 1.000 10002000 10 Lemo n, juice 0.600000 0.100 1.000 10002001 10 Lemon, juice - babyfood 0.600000 0.100 1.000 10002010 10 Lemon, peel 0.600000 1.000 1.000 10002060 10 Lime 0.600000 1.000 1.000 10002070 10 Lime, juice 0.600000 0.100 1.000 10002071 10 Lime, juice - babyfood 0.600000 0.100 1.000 10002400 10 Orange 0.600000 1.000 1.000 10002 410 10 Orange, juice 0.600000 0.100 1.000 10002411 10 Orange, juice - babyfood 0.600000 0.100 1.000 10002420 10 Orange, peel 0.600000 1.000 1.000 10003070 10 Pummelo 0.600000 1.000 1.000 10003690 10 Tangerine 0.600000 1.000 1.000 10003700 10 Tangerine, juice 0.600000 0.100 1.000 11000070 11 Apple, fruit with peel 1.000000 1.000 1.000 11000080 11 Apple, peeled fruit 1.000000 1.000 1.000 11000081 11 Apple, peeled fruit - babyfood 1.000000 1.000 1.000 11000090 11 Apple, dried 1.000000 8.000 1.000 11000091 11 Apple, dr ied - babyfood 1.000000 8.000 1.000 11000100 11 Apple, juice 1.000000 0.040 1.000 11000101 11 Apple, juice - babyfood 1.000000 0.040 1.000 11000110 11 Apple, sauce 1.000 000 1.000 1.000 11000111 11 Apple, sauce - babyfood 1.000000 1.000 1.000 11001290 11 Crabapple 1.000000 1.000 1.000 11002100 11 Loquat 1.000000 1.000 1.000 11002660 1 1 Pear 1.000000 1.000 1.000 11002661 11 Pear - babyfood 1.000000 1.000 1.000 11002670 11 Pear, dried 1.000000 6.250 1.000 11002680 11 Pear, juice 1.000000 1.000 1.000 11002681 11 Pear, juice - babyfood 1.000000 1.000 1.000 11003100 11 Quince 1.000000 1.000 1.000 12000120 12 Apricot 2.500000 1.000 1.000 12000121 12 Apricot - babyfood 2.500000 1.000 1.000 12000130 12 Apricot, dried 2.500000 1.000 1.000 12000140 12 Apricot, juice 2.500000 1.000 1.000 12000141 12 Apricot, juice - babyfood 2.500000 1.000 1.000 12000900 12 Cherry 2.500000 1.000 1.000 12000901 12 Cherry - babyfood 2.500000 1.000 1.000 12000910 12 Cherry, juice 2.500000 1.000 1.000 12000911 12 Cherry, juice - babyfood 2.500000 1.000 1.000 12002300 12 Nectarine 2.500000 1.000 1.000 12002600 12 Peach 2.500000 1.000 1.000 12002601 12 P each - babyfood 2.500000 1.000 1.000 12002610 12 Peach, dried 2.500000 1.000 1.000 12002611 12 Peach, dried - babyfood 2.500000 1.000 1.000 12002620 12 Peach, juice 2.500000 1.000 1.000 12002621 12 Peach, juice - babyfood 2.500000 1.000 1.000 12002850 12 Plum 2.500000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 15 of 22 12002851 12 Plum - babyfood 2.500000 1.000 1.000 12 002860 12 Plum, prune, fresh 2.500000 1.000 1.000 12002861 12 Plum, prune, fresh - babyfood 2.500000 1.000 1.000 12002870 12 Plum, prune, dried 2.500000 1.000 1.000 12002871 12 Plum, prune, dried - babyfood 2.500000 1.000 1.000 12002880 12 Plum, prune, juice 2.500000 1.000 1.000 12002881 12 Plum, prune, juice - babyfood 2.500000 1.000 1.000 14000030 14 Almond 0.030000 1.00 0 1.000 14000031 14 Almond - babyfood 0.030000 1.000 1.000 14000040 14 Almond, oil 0.030000 1.000 1.000 14000041 14 Almond, oil - babyfood 0.030000 1.000 1.000 14000590 14 Brazil nut 0.030000 1.000 1.000 14000680 14 Butternut 0.030000 1.000 1.000 14000810 14 Cashew 0.030000 1.000 1.000 14000920 14 Chestnut 0. 030000 1.000 1.000 14001550 14 Filbert 0.030000 1.000 1.000 14001560 14 Filbert, oil 0.030000 1.000 1.000 14001850 14 Hickory nut 0.030000 1.000 1.000 1400213 0 14 Macadamia nut 0.030000 1.000 1.000 14002690 14 Pecan 0.030000 1.000 1.000 14002820 14 Pistachio 0.030000 1.000 1.000 14003910 14 Walnut 0.030000 1.000 1.000 15000250 15 Barley, pearled barley 0.010000 1.000 1.000 15000251 15 Barley, pearled barley - babyfood 0.010000 1.000 1.000 15000260 15 Barley, flour 0.010000 1.000 1. 000 15000261 15 Barley, flour - babyfood 0.010000 1.000 1.000 15000270 15 Barley, bran 0.010000 1.000 1.000 15001270 15 Corn, sweet 0.010000 1.000 1.000 15001271 15 Corn, sweet - babyfood 0.010000 1.000 1.000 15002310 15 Oat, bran 0.010000 1.000 1.000 15002320 15 Oat, flour 0.010000 1.000 1.000 15002321 15 Oat, flour - babyfood 0.01000 0 1.000 1.000 15002330 15 Oat, groats/rolled oats 0.010000 1.000 1.000 15002331 15 Oat, groats/rolled oats - babyfood 0.010000 1.000 1.000 15003280 15 Rye, grain 0.010000 1.000 1.000 15003290 15 Rye, flour 0.010000 1.000 1.000 15004010 15 Wheat, grain 0.020000 1.000 1.000 15004011 15 Wheat, grain - babyfood 0.020000 1.000 1.000 15004020 15 Wheat, flour 0.020000 1.000 1.000 15004021 15 Wheat, flour - babyfood 0.020000 1.000 1.000 15004030 15 Wheat, germ 0.020000 1.000 1.000 15004040 15 Wheat, bran 0.020000 1.000 1.000 20003190 20 Rapeseed, oil 0.010000 1.000 1.000 20003191 20 Rapeseed, oil - babyfood 0.010000 1.000 1.000 21000440 M Beef, meat 0.050000 1.000 1.000 21000441 M Beef, meat - babyf ood 0.050000 1.000 1.000 21000450 M Beef, meat, dried 0.050000 1.920 1.000 21000460 M Beef, meat byproducts 0.100000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 0.100000 1 .000 1.000 21000470 M Beef, fat 0.100000 1.000 1.000 21000471 M Beef,fat - babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 0.100000 1.000 1.000 21000490 M Bee f, liver 0.400000 1.000 1.000 21000491 M Beef, liver - babyfood 0.400000 1.000 1.000 23001690 M Goat, meat 0.050000 1.000 1.000 23001700 M Goat, meat byproducts 0.100000 1.000 1.000 23001710 M Goat, fat 0.100000 1.000 1.000 23001720 M Goat, kidney 0.100000 1.000 1.000 23001730 M Goat, liver 0.400000 1.000 1.000 2400 1890 M Horse, meat 0.050000 1.000 1.000 25002900 M Pork, meat 0.050000 1.000 1.000 25002901 M Pork, meat - babyfood 0.050000 1.000 1.000 25002910 M Pork, skin 0.100000 1.000 1.000 25002920 M Pork, meat byproducts 0.100000 1.000 1.000 25002921 M Pork, meat byproducts - babyfood 0.100000 1.000 1.000 25002930 M Pork, fat 0.100000 1.000 1.000 25002931 M Pork, fat - babyfood 0.100000 1.000 1.000 25002940 M Pork, kidney 0.100000 1.000 1.000 25002950 M Pork, liver 0.400000 1.000 1.000 26003390 M Sheep, m eat 0.050000 1.000 1.000 26003391 M Sheep, meat - babyfood 0.050000 1.000 1.000 26003400 M Sheep, meat byproducts 0.100000 1.000 1.000 26003410 M Sheep, fat 0.10 0000 1.000 1.000 26003411 M Sheep, fat - babyfood 0.100000 1.000 1.000 26003420 M Sheep, kidney 0.100000 1.000 1.000 26003430 M Sheep, liver 0.400000 1.000 1.000 27002220 D Milk, fat 0.010000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 16 of 22 27002221 D Milk, fat - baby food/infant for 0.010000 1.000 1.000 27012230 D Milk, nonfat solids 0.010000 1.000 1.000 27012231 D Milk, nonfat solids - baby f ood/in 0.010000 1.000 1.000 27022240 D Milk, water 0.010000 1.000 1.000 27022241 D Milk, water - babyfood/infant form 0.010000 1.000 1.000 27032251 D Milk, sugar (lactose) - baby food/ 0.010000 1.000 1.00 0 70001450 P Egg, whole 0.020000 1.000 1.000 70001451 P Egg, whole - babyfood 0.020000 1.000 1.000 70001460 P Egg, white 0.020000 1.000 1.000 70001461 P Egg, white (s olids) - babyfood 0.020000 1.000 1.000 70001470 P Egg, yolk 0.020000 1.000 1.000 70001471 P Egg, yolk - babyfood 0.020000 1.000 1.000 86010000 O Water, direct, all sources 0.015800 1.000 1.000 86020000 O Water, indirect, all sources 0.015800 1.000 1.000 95000230 O Banana 0.200000 1.000 1.000 95000231 O Banana - babyfood 0.200000 1.000 1.000 95000240 O Banana, dried 0.200000 3.900 1.000 95000241 O Banana, dried - babyfood 0.200000 3.900 1.000 95001280 O Cottonseed, oil 0.050000 1.000 1.000 95001281 O Cottonseed, oil - babyfood 0.050000 1.000 1.000 95001750 O Grape 4.000000 1.000 1.000 95001760 O Grape, juice 4.000000 0.200 1.000 95001761 O Grape, juice - babyfood 4.000000 0.200 1.000 9 5001770 O Grape, leaves 4.000000 1.000 1.000 95001780 O Grape, raisin 6.000000 1.000 1.000 95001790 O Grape, wine and sherry 4.000000 1.000 1.000 95002150 O Mango 0.070000 1.000 1.000 95002151 O Mango - babyfood 0.070000 1.000 1.000 95002160 O Mango, dried 0.070000 1.000 1.000 95002170 O Mango, juice 0.070000 1.0 00 1.000 95002171 O Mango, juice - babyfood 0.070000 1.000 1.000 95002450 O Papaya 0.300000 1.000 1.000 95002451 O Papaya - babyfood 0.300000 1.000 1.000 95002460 O Papay a, dried 0.300000 1.800 1.000 95002470 O Papaya, juice 0.300000 1.500 1.000 95002830 O Plantain 0.200000 1.000 1.000 95002840 O Plantain, dried 0 .200000 3.900 1.000 95003590 O Strawberry 2.500000 1.000 1.000 95003591 O Strawberry - babyfood 2.500000 1.000 1.000 95003600 O Strawberry, juice 2.500000 1.000 1.000 950036 01 O Strawberry, juice - babyfood 2.500000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 17 of 22 **Attachment 2 : DEEM**  **- FCID**   **Acute Exposure Estimates** U.S. Environmental Protection Agency Ver. 2.02 DEEM - FCID ACUTE Analysis for DIF ENOCONAZOLE (1994 - 98 data) Residue file: difenoconazole_acute - 05 - 11.R98 Adjustment factor #2 used. Analysis Date: 05 - 10 - 2011/07:05:35 Residue file dated: 05 - 10 - 2011/07:02:12/8 Daily totals for food and foodform consumption used. Run Comment: "" =============================================================================== Summary calculations (per capita): 95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- U.S. Population: 0.020538 8.22 0.055384 22.15 0.143944 57.58 All infants: 0. 039780 15.91 0.062606 25.04 0.118345 47.34 Children 1 - 2 yrs: 0.047638 19.06 0.094024 37.61 0.252955 101.18 Children 3 - 5 yrs: 0.037050 14.82 0.076959 30.78 0.375828 150.33 Children 6 - 12 yrs: 0.021576 8.63 0.044683 17.87 0.148114 59.25 Youth 13 - 19 yrs: 0.011240 4.50 0.039654 15.86 0.137650 55.06 Adults 20 - 49 yrs: 0.014699 5.88 0.041863 16.75 0.109721 43.89 Adults 50+ yrs: 0.019351 7.74 0.063235 25.29 0.138873 55.55 Females 13 - 49 yrs: 0.015084 6.03 0.042143 16.86 0.121368 48.55Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 18 of 22 **Attachment 3 :**  **DEEM -**  **FCID**  **Chronic Residue File** Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 128847 Difenoconazole 0F7785 May 2011 \ difenoconazole_chronic - 05 - 11AverageFT.R98 Chemical: Difenoconazole RfD(Chronic): .01 mg/kg bw/day NOEL(Chron ic): 0 mg/kg bw/day RfD(Acute): .25 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 05 - 10 - 2011/07:03:40/8 Program ver. 2.03

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 01010520 1A Beet, sugar 0.300000 1.000 1.000 01010521 1A Beet, sugar - babyfood 0.300000 1.000 1.000 01010530 1A Beet, sugar, molasses 0.300000 0.600 1.000 01010531 1A Beet, sugar, molasses - babyfood 0.300000 0.600 1. 000 01010780 1AB Carrot 0.062000 1.000 1.000 01010781 1AB Carrot - babyfood 0.062000 1.000 1.000 01010790 1AB Carrot, juice 0.062000 1.000 1.000 01032960 1C Potato, chi ps 0.005000 0.500 1.000 01032970 1C Potato, dry (granules/ flakes) 0.005000 0.500 1.000 01032971 1C Potato, dry (granules/ flakes) - b 0.005000 0.500 1.000 01032980 1C Potato, flour 0.00500 0 0.500 1.000 01032981 1C Potato, flour - babyfood 0.005000 0.500 1.000 01032990 1C Potato, tuber, w/peel 0.005000 1.000 1.000 01032991 1C Potato, tuber, w/peel - babyfood 0.005000 1.000 1.000 01033000 1C Potato, tuber, w/o peel 0.005000 1.000 1.000 01033001 1C Potato, tuber, w/o peel - babyfood 0.005000 1.000 1.000 03001640 3 Garlic 0.200000 1.000 1.000 03001650 3 Garlic, dried 0.200000 1.000 1.000 03001651 3 Garlic, dried - babyfood 0.200000 1.000 1.000 03001980 3 Leek 6.000000 1.000 1.000 03002370 3 Onion, dry bulb 0.200000 1.000 1.000 03002371 3 Onion, dry bulb - babyfood 0.200000 1.000 1.000 03002380 3 Onion, dry bulb, dried 0.200000 9.000 1.000 03002381 3 Onion, dry bulb, dried - babyfood 0.200000 9.000 1.000 03002390 3 Onion, green 6.000000 1.000 1.000 03003380 3 Shallot 0.200000 1.000 1.000 05010610 5A Broccoli 0.221000 1.000 1.000 05010611 5A Broccoli - babyfood 0.221000 1 .000 1.000 05010620 5A Broccoli, Chinese 0.221000 1.000 1.000 05010640 5A Brussels sprouts 29.000000 1.000 1.000 05010690 5A Cabbage 0.029000 1.000 1.000 05010710 5A Cab bage, Chinese, napa 0.029000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 0.221000 1.000 1.000 05010830 5A Cauliflower 0.221000 1.000 1.000 05011960 5A Kohlrabi 0.029000 1.000 1.000 05020630 5B Broccoli raab 5.100000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 5.100000 1.000 1.000 05021170 5B Collards 5.100000 1.000 1.000 0502 1940 5B Kale 5.100000 1.000 1.000 05022290 5B Mustard greens 5.100000 1.000 1.000 05023180 5B Rape greens 5.100000 1.000 1.000 05023890 5B Turnip, greens 5.100000 1.000 1.000 06003470 6 Soybean, seed 0.021500 1.000 1.000 06003480 6 Soybean, flour 0.021500 1.000 1.000 06003481 6 Soybean, flour - babyfood 0.021500 1.000 1.000 06003490 6 Soybean, soy milk 0.021500 1.000 1.000 06003491 6 Soybean, soy milk - babyfood or in 0.021500 1.000 1.000 06003500 6 Soybean, oil 0.021500 1.000 1.000 06003501 6 Soybean, oil - babyfood 0.021500 1.000 1.000 06030980 6C Chickpea, seed 0.017000 1.000 1.000 06030981 6C Chickpea, seed - babyfood 0.017000 1.000 1.000 06030990 6C Chickpea, flour 0.01 7000 1.000 1.000 08001480 8 Eggplant 0.133000 1.000 1.000 08002340 8 Okra 0.600000 1.000 1.000 08002700 8 Pepper, bell 0.133000 1.000 1.000 08002701 8 Pepper, bell - babyfood 0.133000 1.000 1.000 08002710 8 Pepper, bell, dried 0.133000 1.000 1.000 08002711 8 Pepper, bell, dried - babyfood 0.133000 1.000 1.000 08002720 8 Pepper, nonbell 0.133000 1.000 1.000 08002721 8 Pepper, nonbell - babyfood 0.133000 1.000 1.000 08002730 8 Pepper, nonbell, dried 0.133000 1.000 1.000 08003740 8 Tomatillo 0.165000 1.000 1.00 0Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 19 of 22 08003750 8 Tomato 0.165000 1.000 1.000 08003751 8 Tomato - babyfood 0.165000 1.000 1.000 08003760 8 Tomato, paste 0.165000 1.600 1.000 08003761 8 Tomato, paste - babyfood 0.165000 1.600 1.000 08003770 8 Tomato, puree 0.165000 0.500 1.000 08003771 8 Tomato, puree - babyfood 0.165000 0.500 1.000 08003780 8 Tomato, dried 0.165000 14.300 1.000 08003781 8 Tomato, dried - babyfood 0.165000 14.300 1.000 08003790 8 Tomato, juice 0.165000 1.500 1.000 09010750 9A Cantaloupe 0.137000 1.000 1.000 09010800 9A Casaba 0.137000 1.000 1.000 09011870 9A Honeydew melon 0.137000 1.000 1.000 09013990 9A Watermelon 0.137000 1.000 1.000 09014000 9A Watermelon, juice 0.137000 1.000 1.000 09020210 9B Balsam pear 0.055000 1.000 1.000 09020880 9B Chayote, fruit 0.310000 1.000 1.000 09021020 9B Chinese waxgourd 0.055000 1.000 1.000 0 9021350 9B Cucumber 0.055000 1.000 1.000 09023080 9B Pumpkin 0.031000 1.000 1.000 09023090 9B Pumpkin, seed 0.031000 1.000 1.000 09023560 9B Squash, summer 0.031000 1.000 1.000 09023561 9B Squash, summer - babyfood 0.031000 1.000 1.000 09023570 9B Squash, winter 0.031000 1.000 1.000 09023571 9B Squash, winter - babyfood 0.031000 1.0 00 1.000 10001060 10 Citrus citron 0.208000 1.000 1.000 10001070 10 Citrus hybrids 0.208000 1.000 1.000 10001080 10 Citrus, oil 25.000000 1.000 1.000 10001800 10 Grape fruit 0.120000 1.000 1.000 10001810 10 Grapefruit, juice 0.120000 0.100 1.000 10001970 10 Kumquat 0.208000 1.000 1.000 10001990 10 Lemon 0 .176000 1.000 1.000 10002000 10 Lemon, juice 0.176000 0.100 1.000 10002001 10 Lemon, juice - babyfood 0.176000 0.100 1.000 10002010 10 Lemon, peel 0.176000 1.000 1.000 100020 60 10 Lime 0.176000 1.000 1.000 10002070 10 Lime, juice 0.176000 0.100 1.000 10002071 10 Lime, juice - babyfood 0.176000 0.100 1.000 10002400 10 Orange 0.208000 1.000 1.000 10002410 10 Orange, juice 0.208000 0.100 1.000 10002411 10 Orange, juice - babyfood 0.208000 0.100 1.000 10002420 10 Orange, peel 0.208000 1.000 1 .000 10003070 10 Pummelo 0.120000 1.000 1.000 10003690 10 Tangerine 0.208000 1.000 1.000 10003700 10 Tangerine, juice 0.208000 0.100 1.000 11000070 11 Apple, fru it with peel 0.203000 1.000 1.000 11000080 11 Apple, peeled fruit 0.203000 1.000 1.000 11000081 11 Apple, peeled fruit - babyfood 0.203000 1.000 1.000 11000090 11 Apple, dried 0.2030 00 8.000 1.000 11000091 11 Apple, dried - babyfood 0.203000 8.000 1.000 11000100 11 Apple, juice 0.203000 0.040 1.000 11000101 11 Apple, juice - babyfood 0.203000 0.040 1.000 11000110 11 Apple, sauce 0.203000 1.000 1.000 11000111 11 Apple, sauce - babyfood 0.203000 1.000 1.000 11001290 11 Crabapple 0.203000 1.000 1.000 11002100 11 Loquat 0.123000 1.000 1.000 11002660 11 Pear 0.123000 1.000 1.000 11002661 11 Pear - babyfood 0.123000 1.000 1.000 11002670 11 Pear, dried 0.123000 6.250 1.000 11002680 11 Pear, juice 0.123000 1.000 1.000 11002681 11 Pear, juice - babyfood 0.123000 1.000 1.000 11003100 11 Quince 0.123000 1.000 1.000 12000120 12 Apricot 0.421000 1.000 1.000 12000121 12 Apricot - babyfood 0.421000 1.000 1.000 12000130 12 Apricot, dried 0.421000 1.000 1.000 12000140 12 Apricot, juice 0.421000 1.000 1.000 12000141 12 Apricot, juice - babyfood 0.421000 1.000 1.000 12000900 12 Cherry 0.622000 1.000 1.000 12000901 12 Cherry - babyfood 0.622000 1.000 1.000 12000910 12 Ch erry, juice 0.622000 1.000 1.000 12000911 12 Cherry, juice - babyfood 0.622000 1.000 1.000 12002300 12 Nectarine 0.421000 1.000 1.000 12002600 12 Peach 0.421000 1.000 1.000 12002601 12 Peach - babyfood 0.421000 1.000 1.000 12002610 12 Peach, dried 0.421000 1.000 1.000 12002611 12 Peach, dried - babyfood 0.421000 1.000 1.000 120 02620 12 Peach, juice 0.421000 1.000 1.000 12002621 12 Peach, juice - babyfood 0.421000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 20 of 22 12002850 12 Plum 0.295000 1.000 1.000 12002851 12 Plum - babyfood 0.295000 1.000 1.000 12002860 12 Plum, prune, fresh 0.295000 1.000 1.000 12002861 12 Plum, prune, fresh - babyfood 0.295000 1.000 1.000 12002870 12 Plum, prune, dried 0.295000 2.600 1.000 12002871 12 Plum, prune, dried - babyfood 0.295000 2.600 1.000 12002880 12 Plum, prune, juice 0.295000 1.000 1.000 12002881 12 Plum, prune, juice - babyfood 0.295000 1.000 1.000 14000030 14 Almond 0.005000 1.000 1.000 14000031 14 Almond - babyfood 0.005000 1.000 1.000 14000040 14 Almond, oil 0.005000 1.000 1.000 14000041 14 Almond, oil - babyfood 0.0 05000 1.000 1.000 14000590 14 Brazil nut 0.007000 1.000 1.000 14000680 14 Butternut 0.007000 1.000 1.000 14000810 14 Cashew 0.007000 1.000 1.000 14000920 14 Chestnut 0.005000 1.000 1.000 14001550 14 Filbert 0.007000 1.000 1.000 14001560 14 Filbert, oil 0.007000 1.000 1.000 14001850 14 Hickory nut 0.007000 1.000 1.000 14002130 14 Macadamia nut 0.007000 1.000 1.000 14002690 14 Pecan 0.007000 1.000 1.000 14002820 14 Pistachio 0.005000 1.000 1.0 00 14003910 14 Walnut 0.007000 1.000 1.000 15000250 15 Barley, pearled barley 0.010000 1.000 1.000 15000251 15 Barley, pearled barley - babyfood 0.010000 1.000 1.000 15000260 15 Barley, flou r 0.010000 1.000 1.000 15000261 15 Barley, flour - babyfood 0.010000 1.000 1.000 15000270 15 Barley, bran 0.010000 1.000 1.000 15001270 15 Corn, sweet 0.010000 1.000 1.000 15001271 15 Corn, sweet - babyfood 0.010000 1.000 1.000 15002310 15 Oat, bran 0.010000 1.000 1.000 15002320 15 Oat, flour 0.010000 1.000 1.000 15002321 15 Oat, flour - babyfood 0.010000 1.000 1.000 15002330 15 Oat, groats/rolled oats 0.010000 1.000 1.000 15002331 15 Oat, groats/rolled oats - babyfood 0.010000 1.000 1.000 15003280 15 Rye, grain 0.010000 1.000 1.000 15003290 15 Rye, flour 0.010000 1.000 1.000 15004010 15 Wheat, grain 0.020000 1.000 1.000 15004011 15 Wheat, grain - babyfood 0.020000 1.000 1.000 15004020 15 Wheat, flour 0.020000 1.000 1.000 15004021 15 Wheat, flour - babyfood 0.020000 1.000 1.000 15004030 15 Wheat, germ 0.020000 1.000 1.000 15004040 15 Wheat, bran 0.020000 1.000 1.000 20003190 20 Rapeseed, oil 0.010000 1.000 1.000 20003191 20 Rapeseed, oil - babyfood 0.010000 1.000 1.000 21000440 M Beef, meat 0.050000 1. 000 1.000 21000441 M Beef, meat - babyfood 0.050000 1.000 1.000 21000450 M Beef, meat, dried 0.050000 1.920 1.000 21000460 M Beef, meat byproducts 0.100000 1.000 1.000 21000461 M Beef , meat byproducts - babyfood 0.100000 1.000 1.000 21000470 M Beef, fat 0.100000 1.000 1.000 21000471 M Beef,fat - babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 0.100000 1.000 1.000 21000490 M Beef, liver 0.400000 1.000 1.000 21000491 M Beef, liver - babyfood 0.400000 1.000 1.000 23001690 M Goat, meat 0.050000 1.000 1.000 23001 700 M Goat, meat byproducts 0.100000 1.000 1.000 23001710 M Goat, fat 0.100000 1.000 1.000 23001720 M Goat, kidney 0.100000 1.000 1.000 23001730 M Goat, liver 0.400000 1.000 1.000 24001890 M Horse, meat 0.050000 1.000 1.000 25002900 M Pork, meat 0.050000 1.000 1.000 25002901 M Pork, meat - babyfood 0.050000 1.000 1.000 25002910 M Pork, skin 0.100000 1.000 1.000 25002920 M Pork, meat byproducts 0.100000 1.000 1.000 25002921 M Pork, meat byproducts - babyfood 0.100000 1.000 1.000 25002930 M Pork, fat 0.100000 1.000 1.000 25002931 M Pork, fat - babyfood 0.100000 1.000 1.000 25002940 M Pork, kidney 0.100000 1.000 1.000 25002950 M Pork, liver 0.400 000 1.000 1.000 26003390 M Sheep, meat 0.050000 1.000 1.000 26003391 M Sheep, meat - babyfood 0.050000 1.000 1.000 26003400 M Sheep, meat byproducts 0.100000 1.000 1.000 26003410 M Sheep, fat 0.100000 1.000 1.000 26003411 M Sheep, fat - babyfood 0.100000 1.000 1.000 26003420 M Sheep, kidney 0.100000 1.000 1.000 26003430 M Sheep, liver 0.400000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 21 of 22 27002220 D Milk, fat 0.010000 1.000 1.000 27002221 D Milk, fat - baby food/infant for 0.010000 1.000 1.000 27012230 D Milk, nonfat solids 0.010000 1.000 1.000 27012231 D Milk, nonfat solids - baby food/in 0.010000 1.000 1.000 27022240 D Milk, water 0.010000 1.000 1.000 27022241 D Milk, water - babyfood/infant form 0.010000 1.000 1.000 27032251 D Milk, sugar (l actose) - baby food/ 0.010000 1.000 1.000 70001450 P Egg, whole 0.020000 1.000 1.000 70001451 P Egg, whole - babyfood 0.020000 1.000 1.000 70001460 P Egg, white 0.020000 1.000 1.000 70001461 P Egg, white (solids) - babyfood 0.020000 1.000 1.000 70001470 P Egg, yolk 0.020000 1.000 1.000 70001471 P Egg, yolk - babyfood 0.020000 1.000 1.000 86010000 O W ater, direct, all sources 0.010400 1.000 1.000 86020000 O Water, indirect, all sources 0.010400 1.000 1.000 95000230 O Banana 0.200000 1.000 1.000 95000231 O Banana - babyfood 0.200000 1.000 1.000 95000240 O Banana, dried 0.200000 3.900 1.000 95000241 O Banana, dried - babyfood 0.200000 3.900 1.000 95001280 O Cottonseed, oil 0.050000 1.000 1.000 95 001281 O Cottonseed, oil - babyfood 0.050000 1.000 1.000 95001750 O Grape 0.613000 1.000 1.000 95001760 O Grape, juice 0.613000 0.200 1.000 95001761 O Grape, juice - babyfo od 0.613000 0.200 1.000 95001770 O Grape, leaves 0.613000 1.000 1.000 95001780 O Grape, raisin 0.613000 3.500 1.000 95001790 O Grape, wine and sherry 0.613000 1.00 0 1.000 95002150 O Mango 0.070000 1.000 1.000 95002151 O Mango - babyfood 0.070000 1.000 1.000 95002160 O Mango, dried 0.070000 1.000 1.000 95002170 O Mango, juice 0.070000 1.000 1.000 95002171 O Mango, juice - babyfood 0.070000 1.000 1.000 95002450 O Papaya 0.300000 1.000 1.000 95002451 O Papaya - babyfood 0. 300000 1.000 1.000 95002460 O Papaya, dried 0.300000 1.800 1.000 95002470 O Papaya, juice 0.300000 1.500 1.000 95002830 O Plantain 0.200000 1.000 1.000 9500284 0 O Plantain, dried 0.200000 3.900 1.000 95003590 O Strawberry 0.495000 1.000 1.000 95003591 O Strawberry - babyfood 0.495000 1.000 1.000 95003600 O Strawberry, juice 0.495000 1.000 1.000 95003601 O Strawberry, juice - babyfood 0.495000 1.000 1.000Difenoconazole Dietary Exposure Assessment DP#: 389652

PC Code: 128847



### 22 of 22 **Attachm ent 4**  **: DEEM -**  **FCID**  **Chronic Exposure Estimates** U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for DIFENOCONAZOLE (1994 - 98 data) Residue file name: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 128847 Difenoconazole 0F7785 May 2011 \ difenoconazole_chronic - 05 - 11AverageFT.R98 Adjustment factor #2 used. Analysis Date 05 - 10 - 2011/07:07:12 Residue file dated: 05 - 10 - 2011/07:03:40/8 Reference dose (RfD, Chronic) = .01 mg/kg bw/day

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

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

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

-------------------------------------- ------------- -- ------------- U.S. Population (total) 0.001687 16.9% U.S. Population (spring season) 0.001678 16.8% U.S. Population (summer season) 0.001793 17.9% U.S. Population (au tumn season) 0.001618 16.2% U.S. Population (winter season) 0.001659 16.6% Northeast region 0.001620 16.2% Midwest region 0.001651 16.5% Southern region 0.001578 15.8% Western region 0.001956 19.6% Hispanics 0.001605 16.1% Non - hispani c whites 0.001609 16.1% Non - hispanic blacks 0.001946 19.5% Non - hisp/non - white/non - black 0.002414 24.1% All infants (< 1 year) 0.003001 30.0% Nursing infants 0.001638 16.4% Non - nursing infants 0.003518 35.2% Children 1 - 6 yrs 0.003782 37.8% Chil dren 7 - 12 yrs 0.001901 19.0% Females 13 - 19 (not preg or nursing) 0.001191 11.9% Females 20+ (not preg or nursing) 0.001484 14.8% Females 13 - 50 yrs 0.001445 14.5% Females 13+ (preg/not nursing) 0.001325 13.3% Females 13+ (nursing) 0.001582 15.8% Males 13 - 19 yrs 0.001419 14 .2% Males 20+ yrs 0.001323 13.2% Seniors 55+ 0.001597 16.0% Children 1 - 2 yrs 0.004573 45.7% Children 3 - 5 yrs 0.003607 36.1% Children 6 - 12 yrs 0.002027 20.3% Youth 13 - 19 yrs 0.001307 13.1% Adults 20 - 49 yrs 0.001317 13.2% Adults 50+ yrs 0.001562 15.6% Females 13 - 49 yrs 0.001373 13.7%

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