Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### UNITED STA **T ES ENVIRONMENTAL PROTECTION AGENCY** 

**WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND**  **POLLUTION PREVENTION** 

### MEMORANDUM **DATE** : 1 1/7 /2014 **SUBJECT** : **Metconazole** Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Actions on Pea and Bean, Dried Shelled, except Soy bean, Subgroup 6C and the Sunflower Subgroup 20B; Expansion of the Canola Tolerance to the Rapeseed Subgroup 20A; and Conversion of the Established Stone Fruit and Tree Nut Crop Groups to the Stone Fruit Group 12 - 12 and the Tree Nut Group 14 - 12.

**FROM:** Nancy

Dodd, Chemist Risk Assessment Branch III (RAB 3 ) Health Effects Division (HED ; 7509P) **THROUGH:** Mohsen Sahafeyan, Chemist

Seyed Tadayon, Chemist Dietary Exposure Science Advisory Council (DESAC) **TO:** Barry

O’Keefe, Risk Assessor RAB 3 /HED (7509P) and Barbara Madden , P M # 0 5 Minor Use and Emergency Response Branch Registration Division (RD; 7505P) **Executive Summary** Acute and chronic aggregate dietary (foo d and drinking water) 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 **PC Code:** 125619 **DP Num ber**  **:** D 423622 **Decision No.:** 487580 **Registration No. :**  59639 - 147 **Petition No.:** 4E8244 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** Dietary Exposure **Case No.:** NA **T XR No.:**  NA **CAS No.:** 125116 - 23 - 6 **MRID No.:** NA **40 CFR:** §180.6 17Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### Nutrition Examination Survey , What We Eat in America (NHAN ES/WWEIA). The anal ys es were conducted in support of a human - health risk assessment for the proposed Section 3 uses of metconazole on the pea and b ean, dried s helled, except s oy bean, s ubgroup 6C and the s unflower s ubgroup 20B; e xpansion of the canola t ole rance to the r apeseed s ubgroup 20A; and c onversion of the e stablished s tone f ruit and tree nut c rop groups to the s tone f ruit group 12 - 12 and the tree nut group 14 - 12. This memorandum was reviewed b y two peer reviewers of the DESAC, per DESAC SOP 2012.1. Acute Dietary (Food and Drinking W ater) Exposure Assessment An unrefined acute dietary (food and drinking water) exposure assessment was conducted . The residue levels used in the assessment were the established or recommended tolerance level s except for cereal grains and livestock commodities . Since cereal grains and livestock commodities include metabolites as residues of concern in the risk assessment , maximum residue values for the metabolites f rom field trials were added to the metconazol e tolerance levels. DEEM default processing factors or empirical processing factors were used, as available. It was assumed that 100% of the crop s w ere treated. The estimated drinking water concentration (EDWC) used in the acute dietary assessment was pr ovided b y the Environmental Fate and Effects Division ( EFED ) and incorporated directl y into the acute assessment. The groundwater EDWC of 51.8 u g/ L (ppb) generated b y the PRZM - Ground Water (PRZM - GW) model was used in the acute dietary assessment. The highest application rate, which was the application rate for turf, was modeled using the WI Central Sand Scenario in estimating metconazole EDWCs for groundwater. The acute dietary

(food and drinking water) exposure to metconazole is below HED’s level o f concern for females 13 - 49 years old, the onl y population subgroup of concern . For the general U.S. population , including infants and children , an appropriate dose/endpoint attributable to a single dose was not observed in the available oral toxicity studies. The acute dietary exposure estimate at the 95 th 

### percentile is 4.6 % of the aPAD for females 13 - 49 years old, the only population subgroup of concern. Chronic Dietary (Food and Drinking W ater) Exposure Assessment An unrefined chronic dietary (foo d and drinking water) exposure assessment was conducted. The residue levels used in the assessment were the established or recommended tolerance level s except for cereal grains and livestock commodities. Since cereal grains and livestock commodities include metabolites as residues of concern in the risk assessment, maximum residue values for the metabolites f rom field trials were added to the metconazole tolerance levels. DEEM default processing factors or empirical processing factors were used, as available. It was assumed that 100% of the crop s w ere treated. T he EDWC used in the chronic dietary assessment was pr ovided b y EFED and incorporated directly into the chronic assessment. The surface water EDWC of 43.9 u g/ L (ppb) generated by the Surface Water Concentration Calculator (SWCC ) model was used in the chronic dietary assessment. The SWCC model was used to generate EDWCs for the Tier II aquatic exposureMetconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### assessment based on the cranberry scenario. The SWCC is a graphical user interface that runs the Pesticide Root Zone Model (PRZM, v 5, November 15, 2006) and the Variable Volume Water Body Model (VVWM, 3/6/2014) (USEPA, 2006b). The default percent cropped area ( PCA ) factor of 1.0 was used. The chronic dietary

(food and drinking water) exposure to metconazole is below HED’s level of concern for the general U.S. population and all population subgroups. The chronic dietary exposure estimates are 6. 6% of the cPAD for the general U.S. population and 14 % of the cPAD for chil dren 1 - 2 years old , the most highl y exposed population subgroup. C ancer Exposure Results and Characterization Metconazole was classified as “n ot likel y to be carcinogenic to humans ; ” therefore, a cancer dietary assessment was not performed. **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 unreasona ble adverse health effects). This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safet y factors. For acute and non - cancer chroni c exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure f

rom Pesticides, A User’s Guide,” 6/21/2000, web link: http://www.epa.gov/fedrgstr/EPA - PEST/2000/July /Day - 12/6061.pdf

; or see SOP 99.6 (8/20/ 19 99). The m o st recent dietary

risk assessment for metconazole was conducted by Amelia Acierto (3/28/2011, D387504 ). **II. Residue Information**  Residues of Concern : The residues of concern for the tolerance expression and risk assessment (DP# 348234, C. Olinger, 2/11/2008 ) are summarized in Table 1 below . The triazole metabolites (1,2,4 - triazole, triazolylalanine, and triazolylacetic acid) are also residues of concern, but they are addressed in a separate dietary exposure assessment document (DP# 414951, T. Morton, 10/24/13 ).Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### Table 1. Summary of Metabolites and Degradates to be included in the Risk Assessment **and Tolerance Expression** 1 ,2 Matrix Residues Included In Risk Assessment Residues Included In Tolerance Expression Plants Primary and Rotational

Crops, except Cereal Grains Metconazole Metconazole Primary and Rotational Crops, Cereal Grains only Metconazole and M11 Metconazole Livestock Metconazole; M1 and its glucuronic acid conjugate; M12; M31 and its glucuronic acid conjugate Metconazole Drinking Water Metconazole Not Applicable 1 For all triazole - containing pesticides, 1,2,4 - triazole, triazolylalanine (TA), and triazolylacetic acid (TAA) should also be included as residues of concern for risk assessment purposes only for plant and livestock commodities. Since these metabolites are common to the entire class of triazole - derivative fun gicides and because of differential toxicity between the metabolites and the various parent compounds, risks associated with exposure to 1,2,4 - T and to TA/TAA are addressed in separate risk assessment documents. 2 M1 = 5 - [(4 - chlorophenyl)methyl] - 2 - me thoxyl - 2 - me thyl - 1 - (1 H - 1,2,4 - triazol - 1 - ylmethyl) - 1 - cyclopentan ol; M11 = 5 - [(4 - chlorophenyl)methoxyl] - 2,2 - dimethyl - 1 - (1 H - 1,2,4 - triazol - 1 - ylmethyl) - 1 - cyclopentanol; M12 = 5 - [(4 - chlorophenyl)methyl] - 2 - carboxyl - 2 - me thyl - 1 - (1 H - 1,2,4 - triazol - 1 - ylmethyl) - 1 - cyclopentanol; M31 = (1S*,3R*,5S*) - 3 - hydroxy - cis - metconazole; 1,2,4 - T = 1 H - 1,2,4 - triazole; TAA = 1 H - 1,2,4 - triazol - 1 - yl acetic acid; TA = 2 - amino - 3 - (1 H - 1,2,4 - triazol - 1 - yl)propanoic acid. 

### Established Tolerances: Tolerances are established under 40 CFR § 180.617 for residues of metconazole, including its metabolites an d degradates , on a variet y of raw agricultural commodities . Compliance with the tolerance levels is to be determined by measuring only metconazole as the sum of its cis - and trans - isomers. Permanent tolerances have been established for a variet y of raw a gricultural and processed commodities . T ime - limited tolerances , set to expire on 12/31/14, have also been established on sugarcane cane and molasses . Recommended Tolerances: In PP#4E 8244 (as shown in Table 2 below) , the Interregional Research Project No. 4 (IR - 4), on behalf of the IR - 4 Project and the Agricultural Experiment Stations of Montana, South Dakota, North Dakota, and Colorado (dry bean), Montana, South Dakota, Idaho, and North Dakota (dry pea), and Kansas, Mo ntana, South Dakota and North Dakota (sunflower), requested the establishment of permanent tolerances and registration for use on the pea and bean, dried shelled, except so ybean, subgroup 6C, and the sunflower subgroup 20B; expansion of the canola toleranc e to the rapeseed subgroup 20A; and conversion of the established stone fruit crop group 12 and tree nut crop group 14 to the stone fruit crop group 12 - 12 and the tree nut crop group 14 - 12.Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### Table **2 .**  **Recommended Metconazole Tolerances for PP#4E 8244**  **. Comm**  **odity HED**  **- Recommended**  **Tolerance s**  **(ppm )**  P e a an d b ean , drie d s h elle d , e x ce p t so y b ean , s ub gro u

p 6 C 0.15 Sun flo we r s ub gro u

p 20 B 0.7 Rap esee d s ub gro u

p 20 A 0.08 F r uit , sto n e , gro u

p 1 2 - 1 2 0.2 Nut , tree , gro u

p 14 - 1 2 0.04 

### Residue Values Used in This Asses sment: T he residue levels used in the assessment are the established or recommended tolerance level s except for cereal grains and livestock commodities. Since cereal grains and livestock commodities include metabolites as residues of concern in the risk assessment, maximum residue values for the metabolites f rom field trials were added to the metconazole tolerance levels. Residue values used for cereal grains and livestock commodities are shown in Table 3 below: **Table 3 . Residue Values Used in**  **DEEM for Cereal Grains and Livestock**  **Commodities Comm**  **odities** HED Recommended Tolerances - Parent only (ppm) Maximum Residue Level For Metabolites (ppm , parent equivalents ) Residue Values Used

in DEEM (ppm) 1 Corn, field, grain 0.02 M11 (0.01) 0.03 Corn, pop, grain 0.02 M11 (0.01) 0.03 Corn, sweet, ke rnel plus cob with husk removed 0.01 M11 (0.01) 0.02 Small grains Barley, grain 2.5 M11 (0.33) 2.83

Oat, grain 1.0 M11 (0.34) 1.34 Ry e, grain 0.25 M11 (0.04) 0.29 Wheat, grain 0.15 M11 (0.03) 0.18 Cattle, meat byproducts 0.04 M1 (0.02) M12 (0.02) M31 (0.02) 0.10 Goat, meat byproducts Horse, meat byproducts Sheep, meat byproducts Egg 0.04 M1 (0.02) M12 (0.02) M31 ( 0.02) 0.10

1 For cereal grains and livestock commodities, the residue values used in the DEEM include the sum of parent (tolerance) and metabolite(s) , reported as parent equivalents . Residues in meat byproducts and eggs are <LOQ (<0.02 ppm for each analyte) .

. 

### Processing Factors : DEEM default processing factors were used for apricot, dried (6.0x), banana/plantain, dried (3.9x), cherry juice (1.5x), corn, field, s yrup (1.5x), cranberry juice (1.1x), peach, dried (7.0x), peanut butter (1.89x), and plum, prune, juice (1.4x). Empirical processing factors , based on processing studies , were used for the bran of barley , oat, and wheat ( 2.0 x), wheat flour (1x), wheat germ (1x), soy bean oil (1x), sugarcane , sugar (1x) (all D348168, N. Dodd, 2/20/08 ; processing factors for barley, oat and wheat commoditiesMetconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### include residues of parent and metabolite M11 from MRID 46902231 ); potato commodities (potato, chips; potato, dry) (1x) (D380990, A. Acierto, 3/24/11); rapeseed oil/sesame oil (1x) (D 4 19223 , N. Dodd, 1 1 / 4 /14 ), and sunflower oil (1x) (D 4 19223 , N. Dodd, 11 /4 /14 ). (The processing factor of 1x was used for processing factors which were ≤1x.) A s eparate tolerance was established for sugarcane molasses under a Section 18 (D 341748, B. O’Keefe, 8/15/08 ) ; therefore , the processing factor was set to 1. Separate tolerances were established for peanut oil and sugar beet molasse s ; therefore, the processing factors were set to 1 (D348168, N. Dodd, 2/20/08). Although concentration was observed in dried prune (2.3x), it was determined that the tolerance for the raw agricultural commodity is adequate to cover the residues in th e processed commodity (D348168, N. Dodd, 2/20/08 ) ; therefore, the processing factor for dried prune is set to 1. The USDA Pe sticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010; however, the samples were not analyzed for metconazole. As a result, residues in fish were not included in the assessment. **III. Percent Crop Treated**  1 00% crop treated (100% CT ) was assumed for all commodities. **IV. Drinking Water Data**  The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memorandum: “ Drinking Water Exposure Assessment for the Section 3 New Use of Metconazole on Pea and Bean (Dried Shelled, Subgroup 6C), and Sunflower (Subgroup 20B) ” (D 418674 , Faruque Khan, Ph.D., 9/30/14 ) and incorporated directly into this dietary

assessment. Water residues w ere incorporated in the DEEM - FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.” Metconazole parent is the only residue of concern considered in the drinking water assessment. No degradates of metconazole were included based on the recommendation from the Residues of Concern Knowledgebase Subcommittee (ROCKS) of HED (USEPA, 2008, D348234 ). For surface water, the Surface Water Concentration Calculator (SWCC v 1.106) model was used to generate EDWCs for the Ti er II aquatic exposure assessment based on cranberry use . The SWCC is a graphical user interface that runs the Pesticide Root Zone Model (PRZM, v 5, November 15, 2006) and the Variable Volume Water Body Model (VVWM, 3/6/2014) (USEPA, 2006b). The default p ercent cropped area ( PCA ) factor of 1.0 was used. For peak exposure and annual mean exposure, l ower EDWCs for surface water were generated using the Tier II Pesticide Root Zone Model and Exposure Analy sis Modeling Sy stem (PRZM EXAMS) , based on metconazole use on PA turf with a PCA factor of 1 . The use on turf reflected the highest application rate (i.e., five applications at 0.6 lb ai/A/application with a 14 - day retreatment interval). Th e modeled EDWCs for pea/bean (dried shelled) and sunflower did not exceed the concentrations from PA turf.Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### For groundwater, the PRZM - Ground Water ( PRZM - GW ) model was used to estimate EDWCs . The highest application rate , which was the application rate for turf, was modeled in estimating metconazole EDWCs for groundwater. Since application rates for proposed uses are lower than turf, no additional PRZM - GW modeling was conducted. T he EDWCs used in HED’s human health dietary risk assessment are bolded in summary Table 4 below . The groundwater EDWC of 51.8 u g/ L (ppb) was used in the acute dietary assessment. The surface water EDWC of 43.9 u g/ L (ppb) was used in the chronic dietary assessment. **Table 4**  **. Recommended EDWCs for the Proposed Uses of Metconazole for Drinking**  **Water Sources** 1 **Drinking Water Source**  **Crop Scenario (M**  **odel)** 

### Peak **Exposure (Acute)**  **(μg/L)** 

### Annual Mean

**Exposure (Non**  **- Cancer**  **Chronic) (μg/L)**  **30 -**  **year Mean**

**Exposure (Cancer**  **Chronic) (μg/L)**  Surface Water Turf 2 45.5 31.3 22.8

Cranberry3 49.6 **43.9** NA 5 Groundwater WI C entral Sand Scenario 4 **51.8** NA 5 20.0 1 Bolded values are the recommended EDWCs for assessing acute and chronic dietary exposures from me tconazole uses . 2 The Tier II model PRZM/EXAMS was used to generate EDWCs for surface water , based on metconazole use on PA turf . A percent cropped area ( PCA) factor of 1 wa s used. 3 The SWCC v 1.106 mo del was used to generate E DW Cs for the Tier II aquatic exposure assessment. The SWCC is a graphical user interface that runs the Pesticide Root Zone Model (PRZM, v 5, November 15, 2006) and the Variable Volume Water Body Model (VVWM, 3/6/2014) (USEPA, 2006b). The default PCA factor o f 1.0 wa s used . 4 The Tier 1 PRZM - GW model was used to reassess groundwater EDWCs for the turf use, which has the highest application rate (5 applications at of 0.6 lbs ai/A/application) . 5 Not applicable. 

### The drinking water models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/ . **V. DEEM -**  **FCID Program and Consumption Information** Metconazole acute and chronic dietary exposure assessments were conducted using the DEEM - FCID, Version 3.16, which incorporates 2003 - 2008 consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consumption of more 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) using publicl y available recipe trans lation 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. However, for acute exposure assessment, consumption data are retained as in dividual consumption events. Based on anal ys is of the 2003 - 2008 WWEIA consumption data, whichMetconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### took into account dietary

patterns and survey

respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the g eneral U.S. population, all infants (<1 ye ar 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 a 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 to produce a residue intake estimate. The resulting residue intake estimate for each food/food for m is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD. This procedure is pe rformed for each population subgroup. For an acute exposure assessment, 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 expres sed as a percentage of the aPAD on both a user (i.e., only 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 po licy , per capita exposure and risk are reported for anal ys es performed at all levels of refinement. However, for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specificall y identified and noted in the risk assessment. **VI. Toxicological Information** The risk assessment team selected endpoints or confirmed endpoints that were selected previously . The Cancer Assessment Review Committee ( CARC ) for metconazole met on November 2, 2005 (memo, Gregory Akerman, Ph.D., TXR# 0054211, 4/14/06). The Metconazole Endpoint Selection meeting was held on December 21, 2005. The Toxicity Advisory Clinic (TAC) met on 1/10/06 to discuss the acute hazard endpoi nt selection and the FQPA selection. The critical studies in which HED has high confidence suggest a low (or no) level of concern for pup susceptibility . Other data in which HED has a lower level of confidence suggests some level of concern for pup su sceptibility . Taken together, there is low concern (and thus low uncertaint y) that the young are more susceptible than adults to metconazole exposures. Thus, the FQPA factor has been removed (i.e., reduced to 1X). A summary

of toxicological endpoints for use in human health risk assessme nt is presented below in Table 5 :Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### Table **5 . Summary of Toxicological Doses and Endpoints for Metconazole for Use in**  **Dietary and Non -**  **Occupational Human Health Risk Assessments Exposure/**  **Scenario Point of** 

**Departure Uncertainty/FQP** 

**A Safety Factors RfD, PAD, Level** 

**of Concern for Risk Assessment**  **Study and Toxicological**

**Effects** Ac ute Dietary (General Population , including Infants and Children) An appropriate dose/endpoint attributable to a single dose was not observed in the

available oral toxicity studies. Ac ute Dietary (Females 13 - 49 years of age) NOAEL= 12

mg/kg/day UF A= 10x

UF H = 10x FQPA SF= 1x Ac ute RfD = 0.12

mg/kg/day aPAD= 0.12 mg/kg/day **Developm ental toxicity in** 

**rats:** LOAEL = 30 mg/kg/day based on increases in skeletal variations (predominantly lumbar ribs) . Chronic Dietary (All Populations) NOAEL= 4.3

mg/kg/day UF A=10x

UF H = 10x FQPA SF= 1x Chronic RfD =

0.04 mg/kg/day cPAD = 0.04 mg/kg/day **Chronic oral toxicity**

**study in rats :**  LOAEL = 13.1 mg/kg/day based on increased liver (M) weights and associated hepatocellular lipid vacuolation (M) and centrilobular hypertrophy(M). Same effects seen in F at 54 mg/kg/day, plus increased spleen wt. Cancer (oral, dermal, inhalation) Classification: “Not likely to be Carcinogenic to Humans” based on convincing

evidence that carcinogenic effects are not likely below a defined dose range. A non genotoxic mode of action for mouse liver tumors wa s established. No quantification is required. 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 (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). 

### VII. Results/Discussion As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCID analy ses estimate the dietary exposure and risk of the U.S. population and various population subgroups. The results reported in Table 6 are for the general U.S. Population, all infants (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, females 13 - 49, adults 20 - 49, and adults 50 - 99 years old. Results of Acute Dietary

(Food and Drinking Water) Exposure and Risk Analy sis The results of the acute dietary (food and drinking water) exposure and risk anal ys is at the 95 th 

### percentile of exposure are reported in Table 6 , below. The acute assessment was performed forMetconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### females 13 - 49 years old only , since an acute endpoint was not identified for the general U . S . population. The acute dietary (food and drinking water) expo s ure is 4 .6 % of the aPAD for females 13 - 49 . Results of Chronic Dietary (Food and Drinking Water) Exposure and Risk Analy sis The results of the chronic dietary (food and drinking water) exposure and risk analy sis are reported in Table 6 , below. The chronic dietary (food and drinking water) exposure to metconazole is below HED’s level of concern for the general U.S. population and all population subgroups. The chronic dietary (food and drinking water) exposure estimates are 6.6 % of the cPAD for the general U.S. population and 14 % of the cPAD for children 1 - 2 years old, the most highly

exposed population subgroup. **Table 6 . Summary of Dietary**  **(Food and Drinking Water )**  **Exposure and Risk for Metconazole**  **. Population Subgroup**  **Acute Dietary (**  **95 th**  **Percentile) Chronic Dietary**  **Cancer Dietary**  **Exposure (m**  **g/kg/day) % aPAD** * **Dietary Exposure**  **(m g/kg/day)**  **% cPAD*** **Dietary Exposure**  **(m g/kg/day)**  **Risk** General U.S. Population

NA NA 0.002653 6.6

N/A N/A All Infants (<1 year old) 0.004963 12 **Children 1**  **- 2 years old**  ***** **0.005391 1**  **4** Children 3 - 5 years old 0.004749 12 Children 6 - 12 years old 0.003241 8. 1 Youth 13 - 19 years old 0.002045 5.1 Adults 20 - 49 years old 0.002549 6. 4 Adults 50 - 99 years old 0.002166 5.4 **Fem ales 13**  **- 49 years**  **old** * **0.005500 4.6**  0.002179 5.4 *T he subpopulation s with the highest risk estimates are bolded . 

### VIII. Characterization of Inputs/Outputs Unrefined acute and chronic dietary exposure assessments were conducted. Except for cereal grains and livestock commodities, the residue levels used in the assessment were the established or recommended tolerance level s. For cereal grains and livestock commodities, maximum residue values for the metabolites f rom field trials were added to the metconazole tolerance levels. It was assumed that 100% of the crop s w ere treated. Default and empirical processing factors were used, as available. EDWCs based on modeling were provided b y EFED and incorporated directly into the acute and c hronic dietary assessments. Although not needed at this time, HED could refine the exposure and risk estimates with the following information: 1) projected market share/percent crop treated data; 2) anticipated residue data; and 3) monitoring data.Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### IX. **Conclusions** Acute and chronic dietary (food and drinking water) exposure assessments were conducted for the proposed/established uses. The acute dietary (food and drinking water) exposure to metconazole is below HED’s level of concern for females 13 - 49 years old, the only population subgroup of concern. The chronic dietary (food and drinking water) exposure to metconazole is below HED’s level of concern for the general U.S. population and all population subgroups. **X. List of Attachments**  1. Acute Food plus Water Residue Input File. 2. Acute Results File. 3. Chronic Food plus Water Residue Input File. 4. Chronic Results File.Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### Attachment 1. Acute Food plus Water Residue Input File Filename: C: \ Users \ ndodd \ Documents \ DEEM Version 3.16 \ Metconazole \ M etconazoleAcuteSunflower.R08 Chemical: Metconazole RfD(Chronic): .04 mg/kg bw/day NOEL(Chronic): 4.3 mg/kg bw/day RfD(Acute): .12 mg/kg bw/day NOEL(Acute): 12 mg/kg bw/day Date created/last modified: 11 - 07 - 2014/15:57:58 Program ver. 3.16, 03 - 08 - d Comment:

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101052000 1A Beet, sugar 0.070000 1.000 1.000 0101052001 1A Beet, sugar - babyfood 0.070000 1.000 1.000 0101053000 1A Be et, sugar, molasses 0.080000 1.000 1.000 D34816

Full comment: D348168 0101053001 1A Beet, sugar, molasses - babyfood 0.080000 1.000 1.000 0103015000 1CD Arrowroot, flour 0.040000 1.000 1.000 010 3015001 1CD Arrowroot, flour - babyfood 0.040000 1.000 1.000 0103017000 1CD Artichoke, Jerusalem 0.040000 1.000 1.000 0103082000 1CD Cassava 0.040000 1.000 1.000 0103082001 1CD Cassava - baby food 0.040000 1.000 1.000 0103139000 1CD Dasheen, corm 0.040000 1.000 1.000 0103166000 1CD Ginger 0.040000 1.000 1.000 0103166001 1CD Ginger - babyfood 0. 040000 1.000 1.000 0103167000 1CD Ginger, dried 0.040000 1.000 1.000 0103296000 1C Potato, chips 0.040000 1.000 1.000 D38099

Full comment: D380990 0103297000 1C Potato, dry (granules/ flakes) 0.040000 1.000 1.000 D38099

Full comment: D380990 0103297001 1C Potato, dry (granules/ flakes) - b 0.040000 1.000 1.000 0103298000 1C Potato, flour 0.040000 1.000 1.000 0103298001 1C Potato, flour - babyfood 0.040000 1.000 1.000 0103299000 1C Potato, tuber, w/peel 0.040000 1.000 1.000 0103299001 1C Potato, tuber, w/peel - babyfood 0.040000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 0.040000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel - babyfood 0.040000 1.000 1.000 0103366000 1CD Sweet potato 0.040000 1.000 1.000 0103366001 1CD Sweet potato - babyfood 0.040000 1.000 1.000 0103371000 1CD Tanier, corm 0.040000 1.000 1.000 0103387000 1CD Turmeric 0.040000 1.000 1.000 0103406000 1CD Yam, true 0.040000 1.000 1.000 0103407000 1CD Yam bean 0.040000 1.000 1.000 0600347000 6 Soybean, seed 0.050000 1.000 1.000 0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 0600349001 6 Soybean, soy milk - babyfood or in 0.050000 1.000 1.000 0600350000 6 Soybean, oil 0.050000 1.000 1.000 D34816

Full comment: D348168 0600350001 6 Soybean, oil - babyfo od 0.050000 1.000 1.000 0601349500 6AB Soybean, vegetable 0.050000 1.000 1.000 0603030000 6C Bean, black, seed 0.150000 1.000 1.000 0603032000 6C Bean, broad, seed 0.150000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.150000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.150000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.150000 1.000 1.000 06030380 00 6C Bean, lima, seed 0.150000 1.000 1.000 0603039000 6C Bean, mung, seed 0.150000 1.000 1.000 0603040000 6C Bean, navy, seed 0.150000 1.000 1.000 0603041000 6C Bean, pink, seed 0.150000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.150000 1.000 1.000 0603098000 6C Chickpea, seed 0.150000 1.000 1.000 0603098001 6C Chickpea, seed - babyfood 0.15000 0 1.000 1.000 0603099000 6C Chickpea, flour 0.150000 1.000 1.000 0603182000 6C Guar, seed 0.150000 1.000 1.000 0603182001 6C Guar, seed - babyfood 0.150000 1.000 1.000 060320 3000 6C Lentil, seed 0.150000 1.000 1.000 0603256000 6C Pea, dry 0.150000 1.000 1.000 0603256001 6C Pea, dry - babyfood 0.150000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0.150000 1.000 1.000 0603348000 6C Soybean, flour 0.050000 1.000 1.000Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

_____________________________________________________________ _____________________________

Page 13 of 19 0603348001 6C Soybean, flour - babyfood 0.050000 1.000 1.000 1201090000 12A Cherry 0.200000 1.000 1.000 1201090001 12A Cherry - babyfood 0.200000 1.000 1.000 1201091000 12A Cherry, juice 0.200000 1.500 1.000 1201091001 12A Cherry, juice - babyfood 0.200000 1.500 1.000 1202012000 12B Apricot 0.200000 1.000 1.000 1202012001 12B Apricot - babyfood 0.200000 1.000 1.000 1202013000 12B Apricot, dried 0.200000 6.000 1.000 1202014000 12B Apricot, juice 0.200000 1.000 1.000 1202014001 12B Apricot, juice - babyfood 0.200000 1.000 1.000 1202230000 12B Nectarine 0.200000 1.000 1.000 1202260000 12B Peach 0.200000 1.000 1.000 1202260001 12B Peach - babyfood 0.200000 1.000 1.000 1202261000 12B Peach, dried 0.200000 7.000 1.000 1202261001 12B Peach, dried - babyfood 0.200000 7.000 1.000 1202262000 12B Peach, juice 0.200000 1.000 1.000 1202262001 12B Peach, juice - babyfood 0.200000 1.000 1.000 1203285000 12C Plum 0.200000 1.000 1.00 0 1203285001 12C Plum - babyfood 0.200000 1.000 1.000 1203286000 12C Plum, prune, fresh 0.200000 1.000 1.000 1203286001 12C Plum, prune, fresh - babyfood 0.200000 1.000 1.000 1203287000 12C Plum, prune, dried 0.200000 1.000 1.000 D34816

Full comment: D348168 1203287001 12C Plum, prune, dried - babyfood 0.200000 1.000 1.000 1203288000 12C Plum, prune, juice 0.200000 1.400 1.000 1203288001 12C Plum, prune, juice - babyfood 0.200000 1.400 1.000 1302057000 13B Blueberry 0.400000 1.000 1.000 1302057001 13B Blueberry - babyfood 0.400000 1.000 1.000 1302136000 13B Currant 0.400000 1.000 1.000 1302137000 13B Currant, dried 0.400000 1.000 1.000 1302149000 13B Elderberry 0.400000 1.000 1.000 1302174000 13B Gooseberry 0.400000 1.000 1.000 1302191000 13B Huckleberry 0.400000 1.000 1.000 1307130000 13G Cranberry 0.400000 1.000 1.000 1307130001 13G Cranberry - babyfood 0.400000 1.000 1.000 1307131000 13G Cranberry, dried 0.400000 1.000 1.000 1307132000 13G Cranberry, juice 0.400000 1.100 1.000 1307132001 13G Cranberry, juice - babyfood 0.400000 1.100 1.000 1400003000 14 Almond 0.040000 1.000 1.000 1400003001 14 Almond - babyfood 0.040000 1.000 1.000 1400004000 14 Almond, oil 0.040000 1.000 1.000 1400004001 14 Almond, oil - babyfood 0.040000 1.000 1.000 1400059000 14 Brazil nut 0.040000 1.000 1.000 1400068000 14 Butternut 0.040000 1.000 1.000 1400081000 14 Cashew 0.040000 1.000 1.00 0 1400092000 14 Chestnut 0.040000 1.000 1.000 1400155000 14 Hazelnut 0.040000 1.000 1.000 1400156000 14 Hazelnut, oil 0.040000 1.000 1.000 1400185000 14 Hicko ry nut 0.040000 1.000 1.000 1400213000 14 Macadamia nut 0.040000 1.000 1.000 1400269000 14 Pecan 0.040000 1.000 1.000 1400278000 14 Pine nut 0.040000 1.000 1.000 1400282000 14 Pistachio 0.040000 1.000 1.000 1400391000 14 Walnut 0.040000 1.000 1.000 1500025000 15 Barley, pearled barley 2.830000 1.000 1.000 1500025001 15 Barley, pearled barley - babyfood 2.830000 1.000 1.000 1500026000 15 Barley, flour 2.830000 1.000 1.000 1500026001 15 Barley, f lour - babyfood 2.830000 1.000 1.000 1500027000 15 Barley, bran 2.830000 2.000 1.000 1500120000 15 Corn, field, flour 0.030000 1.000 1.000 1500120001 15 Corn, field, flour - babyfood 0.030000 1.000 1.000 1500121000 15 Corn, field, meal 0.030000 1.000 1.000 1500121001 15 Corn, field, meal - babyfood 0.030000 1.000 1.000 1500122000 15 Corn, field, bran 0.030000 1.000 1.000 1500123000 15 Corn, field, starch 0.030000 1.000 1.000 1500123001 15 Corn, field, starch - babyfood 0.030000 1.000 1.000 1500124000 15 Corn, field, syrup 0.030000 1.500 1.000 1500124001 15 Corn, f ield, syrup - babyfood 0.030000 1.500 1.000 1500125000 15 Corn, field, oil 0.030000 1.000 1.000 1500125001 15 Corn, field, oil - babyfood 0.030000 1.000 1.000 1500126000 15 Corn, pop 0.030000 1.000 1.000Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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Page 14 of 19 1500127000 15 Corn, sweet 0.020000 1.000 1.000 1500127001 15 Corn, sweet - babyfood 0.020000 1.000 1.000 1500231000 15 Oat, bran 1.340000 2.000 1.00 0 1500232000 15 Oat, flour 1.340000 1.000 1.000 1500232001 15 Oat, flour - babyfood 1.340000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 1.340000 1.000 1.000 1500233001 15 Oat, groats/rolled oats - babyfood 1.340000 1.000 1.000 1500328000 15 Rye, grain 0.290000 1.000 1.000 1500329000 15 Rye, flour 0.290000 1.000 1.000 1500401000 15 Wheat, grain 0.180000 1.000 1.000 1500401001 15 Wheat, grain - babyfood 0.180000 1.000 1.000 1500402000 15 Wheat, flour 0.180000 1.000 1.000 D34816

Full comment: D348168 1500402001 15 Wheat, flour - babyfood 0.180000 1.000 1.000 1500403000 15 Wheat, germ 0.180000 1.000 1.000 D34816

Full comment: D348168 1500404000 15 Wheat, bran 0.180000 2.000 1.000 D34816

Full comment: D348168, MRID 46902231 2001163000 20A Flax seed, oil 0.080000 1.000 1.000 2001319000 20A Rapeseed, oil 0.080000 1.000 1.000 D42362

Full comment: D423622 2001319001 20A Rapeseed, oil - babyfood 0.080000 1.000 1.000 2001336000 20A Sesame, seed 0.080000 1.000 1.000 2001336001 20A Sesame, seed - babyfood 0.080000 1.000 1.000 2001337000 20A S esame, oil 0.080000 1.000 1.000 D42362

Full comment: D423622 2001337001 20A Sesame, oil - babyfood 0.080000 1.000 1.000 2002330000 20B Safflower, oil 0.700000 1.000 1.000 20 02330001 20B Safflower, oil - babyfood 0.700000 1.000 1.000 2002364000 20B Sunflower, seed 0.700000 1.000 1.000 2002365000 20B Sunflower, oil 0.700000 1.000 1.000 D42362

Full comm ent: D423622 2002365001 20B Sunflower, oil - babyfood 0.700000 1.000 1.000 2003128000 20C Cottonseed, oil 0.250000 1.000 1.000 2003128001 20C Cottonseed, oil - babyfood 0.250000 1.000 1.000 3100046000 3 1 Beef, meat byproducts 0.100000 1.000 1.000 3100046001 31 Beef, meat byproducts - babyfood 0.100000 1.000 1.000 3100048000 31 Beef, kidney 0.100000 1.000 1.000 3100049000 31 Beef, liver 0.100000 1.000 1.000 3100049001 31 Beef, liver - babyfood 0.100000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.100000 1.000 1.000 3200172000 32 Goat, kidney 0.100000 1.000 1.000 3200173000 32 Goat, liver 0.100000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.100000 1.000 1.000 3500342000 35 Sheep, ki dney 0.100000 1.000 1.000 3500343000 35 Sheep, liver 0.100000 1.000 1.000 7000145000 70 Egg, whole 0.100000 1.000 1.000 7000145001 70 Egg, whole - babyfood 0.100000 1.000 1.000 7000146000 70 Egg, white 0.100000 1.000 1.000 7000146001 70 Egg, white (solids) - babyfood 0.100000 1.000 1.000 7000147000 70 Egg, yolk 0.100000 1.000 1.000 7000147001 70 Egg, yolk - babyfood 0.100000 1.000 1.000 8601000000 86A Water, direct, all sources 0.051800 1.000 1.000 8602000000 86B Water, indirect, all sources 0.051800 1.000 1.000 9500023000 O Banana 0.100000 1.000 1.000 9500023001 O Banana - babyfood 0.100000 1.000 1.000 9500024000 O Banana, dried 0.100000 3.900 1.000 9500024001 O Banana, dried - babyfood 0.100000 3.900 1.000 9500263000 O Peanut 0.040000 1.000 1.000 9500264000 O Peanut, butter 0.050000 1.890 1.000 9500265000 O Peanut, oil 0.050000 1.000 1.00 0 D34816

Full comment: D348168 9500283000 O Plantain 0.100000 1.000 1.000 9500284000 O Plantain, dried 0.100000 3.900 1.000 9500362000 O Sugarcane, sugar 1.60000 0 1.000 1.000 D34816

Full comment: D348168 9500362001 O Sugarcane, sugar - babyfood 1.600000 1.000 1.000 9500363000 O Sugarcane, molasses 3.200000 1.000 1.000 Sectio

Full comment: Section 18 tolerance =1.6 x 2x 9500363001 O Sugarcane, molasses - babyfood 3.200000 1.000 1.000Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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Page 15 of 19 

### Attachment 2. Acute Results File US EPA Ver. 3.18, 03 - 08 - d DEEM - FCID ACUTE Analysis for METCONAZOLE NHANES 2003 - 2008 2 - Day Residue file: MetconazoleAcuteSunflower.R08 Adjustment factor #2 used. Analysis Date: 11 - 07 - 2014/16:13:21 Residue file dated: 11 - 07 - 2014/15:57:58 NOEL (Acute) = 12.000000 mg/kg body - wt/day RAC/FF intake s ummed over 24 hours Run Comment: " "

=============================================================================== Summary calculations -- per capita:

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

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Female 13 - 49: 0.005500 4.58 2181 0.008947 7.46 1341 0.015703 13.09 764Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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Page 16 of 19 

### Attachment 3. Chronic Food plus Water Residue Input File Filename: C: \ Users \ ndodd \ Documents \ DEEM Version 3.16 \ Metconazole \ MetconazoleChronicSunflower.R08 Chemical: Metconazole RfD(Chronic): .04 mg/kg bw/day NOEL(Chronic): 4.3 mg/kg bw/day RfD(Acute): .12 mg/kg bw/day NOEL(Acute): 12 mg/kg bw/day Date created/last modified: 11 - 07 - 2014/15:59:15 Program ver. 3.16, 03 - 08 - d Comment:

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101052000 1A Beet, sugar 0.070000 1.000 1.000 0101052001 1A Beet, sugar - babyfood 0.070000 1.000 1.000 0101053000 1A Beet, sugar, molasses 0.080000 1.000 1.000 D34816

Full comment: D34816 8 0101053001 1A Beet, sugar, molasses - babyfood 0.080000 1.000 1.000 0103015000 1CD Arrowroot, flour 0.040000 1.000 1.000 0103015001 1CD Arrowroot, flour - babyfood 0.040000 1.000 1.000 0103017000 1CD Articho ke, Jerusalem 0.040000 1.000 1.000 0103082000 1CD Cassava 0.040000 1.000 1.000 0103082001 1CD Cassava - babyfood 0.040000 1.000 1.000 0103139000 1CD Dasheen, corm 0.040000 1.000 1.000 0103166000 1CD Ginger 0.040000 1.000 1.000 0103166001 1CD Ginger - babyfood 0.040000 1.000 1.000 0103167000 1CD Ginger, dried 0.040000 1.000 1.00 0 0103296000 1C Potato, chips 0.040000 1.000 1.000 D38099

Full comment: D380990 0103297000 1C Potato, dry (granules/ flakes) 0.040000 1.000 1.000 D38099

Full comment: D380990 0103297001 1C Po tato, dry (granules/ flakes) - b 0.040000 1.000 1.000 0103298000 1C Potato, flour 0.040000 1.000 1.000 0103298001 1C Potato, flour - babyfood 0.040000 1.000 1.000 0103299000 1C Potato, tuber, w/peel 0.040000 1.000 1.000 0103299001 1C Potato, tuber, w/peel - babyfood 0.040000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 0.040000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel - babyfood 0.040000 1.000 1.000 0103366000 1CD Sweet potato 0.040000 1.000 1.000 0103366001 1CD Sweet potato - babyfood 0.040000 1.000 1.000 0103371000 1CD Tanier, c orm 0.040000 1.000 1.000 0103387000 1CD Turmeric 0.040000 1.000 1.000 0103406000 1CD Yam, true 0.040000 1.000 1.000 0103407000 1CD Yam bean 0.040000 1.000 1.000 0600347000 6 Soybean, seed 0.050000 1.000 1.000 0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 0600349001 6 Soybean, soy milk - babyfood or in 0.050000 1.000 1.000 0600350000 6 Soybean, oil 0.050000 1.000 1.000 D34816

Full comment: D348168 0600350001 6 Soybean, oil - babyfood 0.050000 1.000 1.000 0601349500 6AB Soybean, vegetable 0.050000 1.000 1.000 0603030000 6C Bean, black, seed 0.150000 1.000 1.000 0603032000 6C Bean, broad, seed 0.150000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.150000 1.000 1.000 06030350 00 6C Bean, great northern, seed 0.150000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.150000 1.000 1.000 0603038000 6C Bean, lima, seed 0.150000 1.000 1.000 0603039000 6C Bean, mung, seed 0.150000 1.000 1.000 0603040000 6C Bean, navy, seed 0.150000 1.000 1.000 0603041000 6C Bean, pink, seed 0.150000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.15000 0 1.000 1.000 0603098000 6C Chickpea, seed 0.150000 1.000 1.000 0603098001 6C Chickpea, seed - babyfood 0.150000 1.000 1.000 0603099000 6C Chickpea, flour 0.150000 1.000 1.000 060318 2000 6C Guar, seed 0.150000 1.000 1.000 0603182001 6C Guar, seed - babyfood 0.150000 1.000 1.000 0603203000 6C Lentil, seed 0.150000 1.000 1.000 0603256000 6C Pea, dry 0.150000 1.000 1.000 0603256001 6C Pea, dry - babyfood 0.150000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0.150000 1.000 1.000Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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Page 17 of 19 0603348000 6C Soybean, flour 0.050000 1.000 1.000 0603348001 6C Soybean, flour - babyfood 0.050000 1.000 1.000 1201090000 12A Cherry 0.200000 1.000 1.000 1201090001 12A Cherry - babyfood 0.200000 1.000 1.000 1201091000 12A Cherry, juice 0.200000 1.500 1.000 1201091001 12A Cherry, juice - babyfood 0.200000 1.500 1.000 1202012000 12B Apricot 0.200000 1.000 1.000 1202012001 12B Apricot - babyfood 0.200000 1.000 1.000 1202013000 12B Apricot, dried 0.200000 6.000 1.000 1202014000 12B Apricot, juice 0.200000 1.000 1.000 1202014001 12B Apricot , juice - babyfood 0.200000 1.000 1.000 1202230000 12B Nectarine 0.200000 1.000 1.000 1202260000 12B Peach 0.200000 1.000 1.000 1202260001 12B Peach - babyfood 0.200000 1.000 1.000 1202261000 12B Peach, dried 0.200000 7.000 1.000 1202261001 12B Peach, dried - babyfood 0.200000 7.000 1.000 1202262000 12B Peach, juice 0.200000 1.000 1.00 0 1202262001 12B Peach, juice - babyfood 0.200000 1.000 1.000 1203285000 12C Plum 0.200000 1.000 1.000 1203285001 12C Plum - babyfood 0.200000 1.000 1.000 1203286000 12C Plum, prune, fresh 0.200000 1.000 1.000 1203286001 12C Plum, prune, fresh - babyfood 0.200000 1.000 1.000 1203287000 12C Plum, prune, dried 0.200000 1.000 1.000 D34816

Full comment: D348168 1203287001 12C Plum, prune, dried - babyfood 0.200000 1.000 1.000 1203288000 12C Plum, prune, juice 0.200000 1.400 1.000 1203288001 12C Plum, prune, juice - babyfood 0.200000 1.400 1.000 1302057000 13B Blueberry 0.400000 1.000 1.000 1302057001 13B Blueberry - babyfood 0.400000 1.000 1.000 1302136000 13B Currant 0.400000 1.000 1.000 1302137000 13B Currant, dried 0.400000 1.000 1.000 1302149000 13B Elderberry 0.400000 1.000 1.000 1302174000 13B Gooseberry 0.400000 1.000 1.000 1302191000 13B Huckleberry 0.400000 1.000 1.000 1307130000 13G Cranberry 0.400000 1.000 1.000 1307130001 13G Cranberry - babyfood 0.400000 1.000 1.000 1307131000 13G Cranberry, dried 0.400000 1.000 1.000 1307132000 13G Cranber ry, juice 0.400000 1.100 1.000 1307132001 13G Cranberry, juice - babyfood 0.400000 1.100 1.000 1400003000 14 Almond 0.040000 1.000 1.000 1400003001 14 Almond - babyfood 0.040000 1.000 1.000 1400004000 14 Almond, oil 0.040000 1.000 1.000 1400004001 14 Almond, oil - babyfood 0.040000 1.000 1.000 1400059000 14 Brazil nut 0.040000 1.000 1.00 0 1400068000 14 Butternut 0.040000 1.000 1.000 1400081000 14 Cashew 0.040000 1.000 1.000 1400092000 14 Chestnut 0.040000 1.000 1.000 1400155000 14 Hazel nut 0.040000 1.000 1.000 1400156000 14 Hazelnut, oil 0.040000 1.000 1.000 1400185000 14 Hickory nut 0.040000 1.000 1.000 1400213000 14 Macadamia nut 0.040000 1.000 1.000 1400269000 14 Pecan 0.040000 1.000 1.000 1400278000 14 Pine nut 0.040000 1.000 1.000 1400282000 14 Pistachio 0.040000 1.000 1.000 1400391000 14 Walnut 0.040000 1.000 1.000 1500025000 15 Barley, pearled barley 2.830000 1.000 1.000 1500025001 15 Barley, p earled barley - babyfood 2.830000 1.000 1.000 1500026000 15 Barley, flour 2.830000 1.000 1.000 1500026001 15 Barley, flour - babyfood 2.830000 1.000 1.000 1500027000 15 Barley, bran 2.830000 2.000 1.000 1500120000 15 Corn, field, flour 0.030000 1.000 1.000 1500120001 15 Corn, field, flour - babyfood 0.030000 1.000 1.000 1500121000 15 Corn, field, meal 0.030000 1.000 1.000 1500121001 15 Corn, field, meal - babyfood 0.030000 1.000 1.000 1500122000 15 Corn, field, bran 0.030000 1.000 1.000 1500123000 15 Corn, field, starch 0.030000 1.000 1.000 1500123001 15 Corn, f ield, starch - babyfood 0.030000 1.000 1.000 1500124000 15 Corn, field, syrup 0.030000 1.500 1.000 1500124001 15 Corn, field, syrup - babyfood 0.030000 1.500 1.000 1500125000 15 Corn, field, oil 0.030000 1.000 1.000 1500125001 15 Corn, field, oil - babyfood 0.030000 1.000 1.000Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

_____________________________________________________________ _____________________________

Page 18 of 19 1500126000 15 Corn, pop 0.030000 1.000 1.000 1500127000 15 Corn, sweet 0.020000 1.000 1.00 0 1500127001 15 Corn, sweet - babyfood 0.020000 1.000 1.000 1500231000 15 Oat, bran 1.340000 2.000 1.000 1500232000 15 Oat, flour 1.340000 1.000 1.000 1500232001 15 Oat, flour - babyfood 1.340000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 1.340000 1.000 1.000 1500233001 15 Oat, groats/rolled oats - babyfood 1.340000 1.000 1.000 1500328000 15 Rye, grain 0.290000 1.000 1.000 1500329000 15 Rye, flour 0.290000 1.000 1.000 1500401000 15 Wheat, grain 0.180000 1.000 1.000 1500401001 15 Wheat, grain - babyfood 0.180000 1.000 1.000 1500402000 15 Wheat, flour 0.180000 1.000 1.000 D34816

Full comment: D348168 1500402001 15 Wheat, flour - babyfood 0.180000 1.000 1.000 1500403000 15 Wheat, germ 0.180000 1.000 1.000 D34816

Full comment: D348168 1500404000 15 Wheat, bran 0.180000 2.000 1.000 D34816

Full comment: D348168; MRID 4 6902231 2001163000 20A Flax seed, oil 0.080000 1.000 1.000 2001319000 20A Rapeseed, oil 0.080000 1.000 1.000 D42362

Full comment: D423622 2001319001 20A Rapeseed, oil - babyfood 0.0 80000 1.000 1.000 2001336000 20A Sesame, seed 0.080000 1.000 1.000 2001336001 20A Sesame, seed - babyfood 0.080000 1.000 1.000 2001337000 20A Sesame, oil 0.080000 1.000 1.000 D42 362

Full comment: D423622 2001337001 20A Sesame, oil - babyfood 0.080000 1.000 1.000 2002330000 20B Safflower, oil 0.700000 1.000 1.000 2002330001 20B Safflower, oil - babyfood 0.700000 1. 000 1.000 2002364000 20B Sunflower, seed 0.700000 1.000 1.000 2002365000 20B Sunflower, oil 0.700000 1.000 1.000 D42362

Full comment: D423622 2002365001 20B Sunflower, oil - babyfood 0.700000 1.000 1.000 2003128000 20C Cottonseed, oil 0.250000 1.000 1.000 2003128001 20C Cottonseed, oil - babyfood 0.250000 1.000 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 3100048000 31 Beef, kidney 0.100000 1.000 1.000 3100049000 31 Beef, liver 0.100000 1.000 1.000 3100049001 31 Beef, liver - babyfood 0.100000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.100000 1.000 1.000 3200172000 32 Goat, kidney 0.100000 1.000 1.000 3200173000 32 Goat, liv er 0.100000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.100000 1.000 1.000 3500342000 35 Sheep, kidney 0.100000 1.000 1.000 3500343000 35 Sheep, liver 0.100000 1.000 1.000 7000145000 70 Egg, whole 0.100000 1.000 1.000 7000145001 70 Egg, whole - babyfood 0.100000 1.000 1.000 7000146000 70 Egg, white 0.100000 1.000 1.000 7000146001 70 Egg, white (solids) - babyfood 0.100000 1.000 1.000 7000147000 70 Egg, yolk 0.100000 1.000 1.000 7000147001 70 Egg, yolk - babyfood 0.100000 1.000 1.000 8601000000 86A Water, direct, all sources 0.043900 1.000 1.000 8602000000 86B Water, indirect, all sources 0.043900 1.000 1.000 9500023000 O Banana 0.100000 1.000 1.000 9500023001 O Banana - babyfood 0.100000 1.000 1.000 9500024000 O Banana, dried 0.100000 3.900 1.000 9500024001 O Banana, dried - babyfood 0.100000 3.900 1.000 9500263000 O Peanut 0.040000 1.000 1.00 0 9500264000 O Peanut, butter 0.050000 1.890 1.000 9500265000 O Peanut, oil 0.050000 1.000 1.000 D34816

Full comment: D348168 9500283000 O Plantain 0.10000 0 1.000 1.000 9500284000 O Plantain, dried 0.100000 3.900 1.000 9500362000 O Sugarcane, sugar 1.600000 1.000 1.000 D34816

Full comment: D348168 9500362001 O Sugarcane, sugar - babyfood 1.600000 1.000 1.000 9500363000 O Sugarcane, molasses 3.200000 1.000 1.000 Sectio

Full comment: Section 18 tolerance =1.6 x 2x 9500363001 O Sugarcane, molasses - babyfood 3.200000 1.000 1.000Metconazole Dietary - Exposure and Risk Assessment DP Number: D423622

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### Attachment 4: Chronic Results File US EPA Ver. 3.16, 03 - 08 - d DEEM - FCID Chronic analysis for METCONAZOLE NHANES 2003 - 2008 2 - day Residue file name: C: \ Users \ ndodd \ Documents \ DEEM Versi on 3.16 \ Metconazole \ MetconazoleChronicSunflower.R08 Adjustment factor #2 used. Analysis Date 11 - 07 - 2014/16:15:22 Residue file dated: 11 - 07 - 2014/15:59:15 Reference dose (RfD, Chronic) = .04 mg/kg bw/d ay =============================================================================== Total exposure by population subgroup

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

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

-------------------------------------- ------------- ---------------- Total US Population 0.002653 6.6% Hispanic 0.002641 6.6% Non - Hisp - White 0.002701 6.8% Non - Hisp - Black 0.002353 5.9% Non - Hisp - Other 0.002747 6.9% Nursing Infants 0.002351 5.9% Non - Nursing Infants 0.006129 15.3% Female 13+ PREG 0.002123 5.3% Children 1 - 6 0.004914 12.3% Children 7 - 12 0.003045 7.6% Male 13 - 19 0.002133 5.3% Female 13 - 19/NP 0.001966 4.9% Male 20+ 0.0026 58 6.6% Female 20+/NP 0.002149 5.4% Seniors 55+ 0.002074 5.2% All Infants 0.004963 12.4% Female 13 - 50 0.002174 5.4% Children 1 - 2 0.005391 13.5% Children 3 - 5 0.004749 11.9% Children 6 - 12 0.003241 8.1% Youth 13 - 19 0.002045 5.1% Adults 20 - 49 0.002549 6.4% Adults 50 - 99 0.002166 5.4% Fema le 13 - 49 0.002179 5.4%

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