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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 :**  December 5, 2013 **SUBJECT: Fenamidone**  **–** Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to Support New Uses on Ginseng, Succulent Beans, Bulb Onion (Subgroup 3 - 07A), and Green Onion (Subgrou p 3 - 07B). **PC Code:** 046679 **DP Barcode:**  D416496 **Decision No.:** 475185 **Registration No. :**  **Petition No.:** 3E8150 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** Dietary Risk Assessment **CAS No.:** 161326 - 34 - 7 

### FROM: Karen Milians, Ph.D., Chemist

Risk Assessment Branch 7 Health Effects Division ( 7508 P) **THROUGH:** Dennis McNeill y , Chemist

Meheret Negussie , Chemist Id eliz Negron **-** Encarnacion, Ph.D., Chemist Dietary Exposure Science Advisory Council (DESAC) **TO:** Laura Nollen, Risk Manager Reviewer

Barbara Madden, Risk Manager Registration Division (7505P) **Executive Summary** Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity

Intake Database (DEEM - FCID) Version 3.16 . This software uses 2003 - 2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Su rvey , What We Eat in America, (NHANES/WWEIA). The anal ys es were performed to support the Section 3 request for use on ginseng, succulent beans bulb onion (Subgroup 3 - 07A), and green onion (Subgroup 3 - 07B) . Acute Dietary

Exposure AssessmentFenamidone Dietary Exposure and Risk Assessment DP Number: D416496

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### A slightly unr efined acute dietary

risk assessment was conducted which used maximum field trial residue values, assumed 100 percent crop treated (% CT) for all commodities, incorporated DEEMTM default processing factors and empirical factors were used for processed commo dities and included modeled drinking water estimates. The estimated exposure (food and water) to the U.S. population from the existing and proposed new uses of fenamidone resulted in an estimated risk equivalent to 3% of the acute population adjusted dose (aPAD) at the 95 th 

### percentile. The most highly

exposed subpopulation was children 1 - 2 years with an estimated exposure equivalent to 5 % of the aPAD at the 95 th 

### percentile. Chronic Dietary

Exposure Assessment A chronic dietary

risk assessment was conducted which used maximum field trial residue values, assumed 100 % CT for all commodities, incorporated DEEMTM default processing factors for many processed commodities and included modeled drinking water estimates. The estimated exposure (food and water) to the U.S. population from the existing and proposed new uses of fenamidone resulted in an estimated risk equivalent to 53 % of the chronic population adjusted dose (cPAD). The most highl y exposed subpopulation wa s children 1

– 2 years with an estimated exposure equivalent to 89 % of the cPAD. Cancer Dietary

Exposure Assessment Fenamidone is not likel y to be a human carcinogen; therefore a cancer dietary risk assessment is not required for this chemical. **I. I**  **ntroduction** 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 population adjusted dose (PAD). The PAD is equivalent to point of departure (POD, NOAEL , LOAEL, e.g.) divided by the required uncertainty

or safety factors. For acute and non - canc er chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generall y concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides In Food , A User’s Guide,” 5 - NOV - 20 13 , web link: http://www.epa.gov/fe drgstr/EPA - PEST/2000/July /Day - 12/6061.pdf ; or see SOP 99.6 ( 29 - OCT 2013 ) . The most recent dietary

risk assessment for fenamidone was conducted by Alexandra LaMay (D3 91040, 07/7/11 ). **II. Residue Information** Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

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### Tolerances are currentl y established for residues of fenamidone under 40 CFR 180.579 (a)(1) for a variety of primary

crops including bulb vegetables, cucurbit vegetables, tuberous and corm vegetables, brassica vegetables, leafy vegetables, fruiting vegeta bles, cotton, non bell pepper, sunflower, and tomato ranging from 0.02 ppm to 60 ppm. Li vestock commodity tolerances are established for residues of fenamidone and RPA 717879 (DADK - Fen) in milk, fat, meat and meat by products under 180.579(a)(2). Rotation al crop tolerances are established for residues of fenamidone and RPA 717870 (DADK - Fen) in wheat, corn and soy bean commodities and strawberries ranging from 0.02 ppm to 0.50 ppm under 40CFR 180.579(d). The residues of concern for tolerance setting and ris k assessment purposes are summarized in the table below. **Table 1: Residues of Concern in Primary Crops, Livestock, Rotational Crops, and Water Matrix**  **Tolerance Expression Residues for Risk Assessment**  Registered/proposed primary crops excluding root vegetables fenamidone fenamidone, RPA 717879 (DADK - Fen), RPA 408056 (DA - Fen), RPA 405862 Carrot 1 fenamidone fenamidone, RPA 413255 Animal commodities fenamidone, RPA 717879 (DADK - Fen) fenamidone, RPA 717879 (DADK - Fen), RPA 408056 (DA - Fen) Rotational Crops fenamidone, RPA 717879 (DADK - Fen) fenamidone, RPA 717879 (DADK - Fen), and RPA 408056 (DA - Fen) (free and conjugated) Water NA Fenamidone, RPA 412636, RPA 412708, RPA 411639, RPA 413255, RPA 409446, and RPA 410995 1 For future field trials with the root vegetables, HED recommends that parent f enamidone, and the metabolites RPA 413255, RPA 717879 (DADK - Fen) and RPA 408056 (DA - Fen), and RPA 405862 are measured. 

### The tolerances are presented in the most recent residue chemistry d ocument ( K. Milians, D 409835 ) . The new residues were included in the acute and chronic dietary risk assessment and a description of how they

were calculated are shown in **Table 2** . **Table 2. Summary of New Residue Values Added to the Acute and Chronic Dietary Risk Assessment**  **Crop/Commodity** ***** **Residue Value (ppm)**  **Comment**

Ginseng 1.19 The field rotational crop studies monitored for residues of fenamidone and metabolites (RPA 717879, RPA 408056 and RPA 405862) in ginseng . RPA 413255 is included as a residue of concern for ginseng since it is in the same crop group as carrot , however, this analyte was not determined in the field trials for ginseng. Data from carrot was used to estimate a factor to account for RPA 413255 . The carrot m etabolism study (469291101.der.doc) indicated that residues of RPA 413255 were 0.6x that of fenamidone (D314318, T. Bloem, 7 - Jun - 2007) . The ginseng field trials showed that r esidues of parent fenamidone were 0.35 ppm, conjugated RPA 408056 were 0.024 ppm, RP A 717879 were < 0.02 and RPA 405862 were 0.0 22 for combined residues of 0. 98 ppm ( D409835 , K. Milians ) . Using the 0.6x factor to account for RPA 413255 the combined residue level would be 1.19 ppm (0.98 ppm + 0.35 ppm x 0.21ppm).Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

Page 4 of 14 **Table 2. Summary of New Residue Values Added to the Acute and Chronic Dietary Risk Assessment**  **Crop/Commodity** ***** **Residue Value (ppm)**  **Comment** Snap Bean s 0.52 The field crop studies monitored for residues of fenamidone and metabolites (RPA 717879, RPA 408056 and RPA 405862) in snap beans. Residues of fenamidone, RP A 405862 , RP A 717879, RPA 408056 in snap beans were 0.46, 0.02, 0.02 and 0.02 ppm , respectively, f or a t otal residue of 0.52 ppm ( MRID 4905210 3 ; D409835 , K. Milians ) . Onion, bulb, subgroup 3 - 07A 0.186 Adequate data were previously submitted to establish tolerances on these subgroups based on residue data for bulb onions. A. LaMay (D391040, 07/7/11) Onion, bulb, subgroup 3 - 07 B 1.23 Adequate data were previously submitted to establish tolerances on this subgroup based on residue data for green onions. A. LaMay (D391040, 07/7/11) 

### DEEM  (ver. 7.81) default processing factors were maintained for all commodities excluding grape juice, dried potato, tomato paste, tomato puree, field corn processed commodities and soy bean processed commodities. For these commodities, the DEEM  (ver. 7.81) d efault processing factors were reduced to 1 based on processing data (grape), were reduced to 1 based on the application of empirical processing factors to the RAC residue (tomato paste, tomato puree, and dried potato; D277818, T. Bloem, 4/22/04), or were reduced to 1 based on lack of residues at exaggerated rates in the RAC (field corn processed commodities and soybean processed commodities; D357372, A. LaMay , 2/24/09). **I I**  **I. Percent Crop Treated Information**  For all commodities 100 percent crop treated was assumed. **IV . Drinking**  **Water Data** The drinking water residues used in the dietary risk assessment were provided by the Environmental F ate and Effects Division (EFED, J. K. Wolf , D409837 , 09 / 18 / 13 ) and were incorporated directl y into the acute and chronic dietary assessments. Water residues were incorporated in the DEEM - FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.” Monitoring data are not available for residues of fenamidone and its metabolites in water; therefore EFED has provided modeled values for ground and surface water. The modeled EDWCs (estimated drinking water concentrations) are reported for parent and its degradation products, RPA - 412636, RPA - 412108, RPA - 411639, RPA - 413255, RPA - 409446, and RPA 410995 . These are the residues of concern in drinking water, as determined by the Metabolite Assessment Committee (MARC, 05/25/04). Surface water EDWCs were calculated using a Tier II model for surface water PRZM ( Pesticide Root Zone Model, Version 3.122) and EXAMS (Version 2.98.04) using the PE5 platform . The EDWC in ground water were estimated using the S creening C oncentration In Gro und W ater model (SCI - GROW, Version 2.3) and PRZM - GW (Pesticide Root Zone Model for Groundwater, version 1.0, August 31, 2012 ) . EDWCs in surface source water were corrected using the default percent crop area factor (0. 91 ). The default PCAFenamidone Dietary Exposure and Risk Assessment DP Number: D416496

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### was applied because fenamidone can be used on numerous crops. No water treatment effects were considered in this assessment . These models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/ . The drinking water EDWCs recommended for use in the human health dietary ri sk assessment are those estimated for groundwater. The highest daily total fenamidone residue concentration in shallow groundwater estimated by PRZM - GW is 207μg/L and the average concentration after breakthrough was 139 μg/L for the Central Sands Region o f Wisconsin from 30 years of continuous use. These estimates represent potential exposure to private drinking water well in a highl y vulnerable pesticide use area where numerous pesticide residues have been detected in groundwater. For both the acute and chronic dietary anal ys is, HED will use the maximum ground water EDWC of 207 μg/L ( **0.207 ppm** ), since it is the highest EDWC reported for fenamidone. **Table 3 Summary of Estimated Surface Water and Groundwater Concentrations** 

**for Fenamidone.**  Scenario Surface Water Conc., ppb a Groundwater Conc., ppb b Ac ute 41.7 207 Chronic (non - cancer) 11.9 207 Chronic (cancer) 5.99 207 a From the Tier II PRZM - EXAMS - Index Reservoir model. Input parameters are based on ... b From the PRZM - GW model. USEPA, 2013, J. K. Wolf, D409837 . 

### V. **DEEM -**  **FCID Program and Consumption Information** Fenamidone 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; fres h or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicl y available recipe translation files developed jointly

by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and withi n population subgroups. However, for acute exposure assessment, consumption data are retained as individual consumption events. Based on anal ys is of the 2003 - 2008 WWEIA consumption data, which took into account dietary patterns and survey

respondents, HE D concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50 - 99 ye ars 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.Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

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### The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg body weight/day

and as a percent of the cPAD. This procedure is performed for each population subgroup. For an acute exposure assessment, individual one - day food consumption data are used on an individual - by - individual ba sis. 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 valu es 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., onl y those who reported eating relevant commodities/food forms) and a per - capita (i.e., those who repo rted 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 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 HED Hazard Identification and Assessment Review Committee (HIARC) met on 18 - March 2003 to evaluate the toxicological database for fenamidone (TXR No. 0052379). At that meeting the lack of a developmental neurotoxicity study was indentified and a 10X d atabase uncertainty factor was applied. Subsequent to that finding, the registrant has addressed the data gap, and HED has determined that the database UF is no longer required. Based on toxicological considerations and the residue assumptions used in th e dietary analy ses, HED concludes that the FQPA Safet y Factor can be reduced to 1x when assessing acute and chronic dietary exposures. **Table 3** summarizes the points of departure used for dietary risk assessment. **Table 3. Summary of Toxicological Doses and Endpoints for Fenamidone Dietary**  **Exposure Assessment Exposure**  **Scenario Point of Departure**  **Uncertainty/ FQPA S**  **F RfD and PAD**  **Study and Toxicological Effects** Acute Dietary (All populations) NOAEL = 125

mg/kg/day UF A= 10x

UF H = 10x FQPA SF= 1 Acute RfD = 1.25

mg/kg/day Acute PAD = 1.25 mg/kg/day Acute Neurotoxicity in Rats; LOAEL =

500 mg/kg/day based on urination, staining/soiling of the anogenital region, mucous in the feces, and unsteady gait in the females Chronic Dietary (All populations) NOAEL= 2.83

mg/kg/day UF A= 10x

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

0.0283 mg/kg/day Chronic PAD = 0.0283 mg/kg/day 2 Year Chronic Toxicity/Carcinogenicity in

Rats; LOAEL = 7.07/9.24 mg/kg/day (M/F) based on increase in severity of diffuse thyroid C - cell hyperplasia in both sexes Cancer Based on the negative carcinogenic potential of fenamidone in rats and mice, the HIARC classified

fenamidone as **“not likely”** to be a human carcinogen by all relevant routes of exposure. 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 adver se effect level. LOAE L = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (intraspecies). UF H = potential variation in sensitivity among members of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

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### VII. **Results/Discussion** As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCIDTM anal ys es estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in **Table 4** 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+ years. The estimated exposure (food and water) to the U.S. population from the existing and proposed new uses of fenamidone resulted in an estimated risk equivalent to 3% of the aPAD at the 95 th 

### percentile. The most highly exposed sub population was children 1

– 2 years with an estimated exposure equivalent to 5% of the aPAD at the 95 th 

### percentile. The estimated exposure (food and water) to the U.S. population from the existing and proposed new uses of fenamidone resulted in an estimat ed risk equiv alent to 5 3 % of the cPAD . The most highl y exposed subpopulation was children 1

– 2 years with an estimated exposure equivalent to 8 9 % of the cPAD. The results of the acute and chronic dietary exposure anal ys is are reported in the summary table below ( **Table 4** ). Fenamidone is not likel y to be a human carcinogen; therefore a cancer dietary risk assessment is not required for this chemical. **Table 4. Summary of Dietary (Food and Drinking Water)**  **Exposure and Risk for Fenam idone**  

### Population **Subgroup Acute Dietary**  **(95th 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 0.04 2858 3.4 0.01 4881 5 3

N/A N/A All Infants (< 1 year old) 0.04 9122 3.9 0.0 19601 6 9 Female 13 - 50 years old 0.044 191 3.5 0.01 4513 51 Children 1 - 2 years old **0.059 469**  **4.8 0.02**  **5185 8**  **9** Children 3 - 5 years old 0.05 8 441 4.7 0.0 2 2511 80 Children 6 - 12 years old 0.035 464 2.8 0.0 14602 5 2 Youth 13 - 19 years old 0.03 0767 2.5 0.01 1064 3 9 Adults 20 - 49 years old 0.042 344 3.4 0.01 4350 5 1 Adults 50+ years old 0.04 3906 3.5 0.01 4768 5 2Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

Page 8 of 14 **Table 4. Summary of Dietary (Food and Drinking Water)**  **Exposure and Risk for Fenam idone**  

### Population **Subgroup Acute Dietary**  **(95th 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** Females 13 - 49 years old 0.044 264 3.5 0.01 4516 51 N/A is “not applicable”. Populations with highest exposure are shown in bold. * PAD = population adjusted dose. 

### VIII **. Characterization**  **of Inputs/Outputs** The acute and chronic dietary assessments are considered to be conservative, using field trial data conducted at maximum application rate and minimum PHI and assuming 100% CT for all commodities, as well as using default drying concentr ation factors and empirical factors. The results of the acute and chronic dietary risk assessments are unlikel y to und erestimate risk. **IX. Conclusions**  Slightly refined acute and chronic dietary risk assessments were conducted which used maximum field trial residue values, assumed 100 % CT for all commodities and incorporated DEEMTM default processing factors as well as empirical factors were used for processed commodities. The estimated exposure (food and water) to the U.S. population from the existing and proposed new uses of fenamidone resulted in an estimated risk equivalent to 3 .4 % of the aPAD at the 95 th 

### percentile. The most highly exposed subpopulation was children 1

– 2 years with an estimated exposure equivalent to 5 % of the aPAD at the 95 th 

### percentile. The estimated exposure (food and water) to the U.S. population from the existing and proposed ne w uses of fenamidone resulted in an estimated risk equivalent to 5 3 % of the cPAD. The most highl y exposed subpopulation was children 1

– 2 years with an estimated exposure equivalent to 89 % of the cPAD. Acute and chronic dietary risks from the existing and newl y proposed used of fenamidone are not of concern. **X. List of Attachments**  **Attachment 1 .**  Chronic Dietary Risk Assessment Results file. **Attachment 2 .**  Acute Dietary Risk Assessment Results file. **Attachment 3 .**  Acute and Chronic Food plus Water Residue Input file. **Attachment 1 .**  Fenamidone Chronic Dietary Risk Assessment Results File US EPA Ver. 3.16, 03 - 08 - dFenamidone Dietary Exposure and Risk Assessment DP Number: D416496

Page 9 of 14 DEEM - FCID Chronic analysis for FENAMIDONE NHANES 2003 - 2008 2 - day Residue file name: C: \ Documents and Settings \ kmilians \ Desktop \ MODELS \ DEEM \ FENAMIDONE ACUTE AND CHRONIC F_W041311.R08 Adjustment factor #2 NOT used. Analysis Date 11 - 19 - 20 13/12:08:00 Residue file dated: 11 - 19 - 2013/12:06:01 Reference dose (RfD, Chronic) = .0283 mg/kg bw/day COMMENT 1: 100x uncertainity factor for acute and chronic; 1x FQPA safety factor for acute and chronic; EDWC

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

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

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

-------------------------------------- ------------- ---------------- Total US Population 0.014881 52.6% Hispanic 0.013448 47.5% Non - Hisp - White 0.015116 53.4% Non - Hisp - Black 0.013951 49.3% Non - Hisp - Other 0.017714 62.6% Nursing Infants 0.009144 32.3% Non - Nursing Infants 0.024272 85.8% Female 13+ PREG 0.013363 47.2% Children 1 - 6 0.023021 81.3% Children 7 - 12 0.013691 48.4% Male 13 - 19 0.010802 38.2% Female 13 - 19/NP 0.011339 40.1% Male 20+ 0.013446 47.5% Female 20+/NP 0.015545 54.9% Seniors 55+ 0.014586 51.5% All Infants 0.019601 69.3% Female 13 - 50 0.014513 51.3% Children 1 - 2 0.025185 89.0% Children 3 - 5 0.022511 79.5% Children 6 - 12 0.014602 51.6% Youth 13 - 19 0.011064 39.1% Adults 20 - 49 0.014350 50.7% Adults 50 - 99 0.014768 52.2% Fema le 13 - 49 0.014516 51.3%

-------------------------------------------------------------------------------Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

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### Attachment 2 **.** Fenamidone Acute Dietary Risk Assessment Results File US EPA Ver. 3.18, 03 - 08 - d DEEM - FCID ACUTE Analysis for FENAMIDONE NHANES 2003 - 2008 2 - Day Residue file: FENAMIDONE ACUTE AND CHRONIC F_W041311.R08 Adjustment factor #2 NOT used. Analysis Date: 11 - 19 - 2013/12:10:42 Resi due file dated: 11 - 19 - 2013/12:06:01 NOEL (Acute) = 125.000000 mg/kg body - wt/day RAC/FF intake summed over 24 hours Run Comment: "100x uncertainity factor for acute and chronic; 1x FQPA safety f actor for acute and chronic; EDWC "

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

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

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.042858 3.43 2916 0.083286 6.66 1500 0.159846 12.79 782 All Infants: 0.049122 3.93 2544 0.078634 6.29 1589 0.328697 26.30 380 Female 13 - 50: 0.044191 3.54 2828 0.086806 6.94 1439 0.152918 12.23 817 Children 1 - 2: 0.059469 4.76 2101 0.100903 8.07 1238 0.368654 29.49 339 Children 3 - 5: 0.058441 4.68 2138 0.122948 9.84 1016 0.212424 16.99 588 Children 6 - 12: 0.035464 2.84 3524 0.083108 6.65 1504 0.159590 12.77 783 Youth 13 - 19: 0.030767 2.4 6 4062 0.059223 4.74 2110 0.124518 9.96 1003 Adults 20 - 49: 0.042344 3.39 2952 0.081206 6.50 1539 0.145666 11.65 858 Adults 50 - 99: 0.043906 3.51 2846 0.082755 6.62 1510 0.156961 12.56 796 Female 13 - 49: 0.044264 3.54 2823 0.087130 6.97 1434 0.151727 12.14 823Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

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### Attachment 3 **.** Acute and Chronic Food plus Water Residue Input file. **The residue input file used**  **was the sam e for acute and chronic**  **anal yses,**  **however the reference doses were**  **different; 0**  **.0283 m g/kg bw/day for chronic analysis**  **and 125 m g/kg bw/day for acute**  **.** US EPA Ver. 3.16, 03 - 08 - d DEEM - FCID Chronic analysis for FENAMIDONE Residue fi le: C: \ Documents and Settings \ kmilians \ Desktop \ MODELS \ DEEM \ FENAMIDONE ACUTE AND CHRONIC F_W041311.R08 Adjust. #2 NOT used Analysis Date 11 - 21 - 2013 Residue file dated: 11 - 19 - 2013/13:26:5 7 Reference dose (RfD) = 0.0283 mg/kg bw/day Comment:100x uncertainity factor for acute and chronic; 1x FQPA safety factor for acute and chronic; EDWC

---------------------------------------------------------------------------------- Food Crop Residue Adj.Factors EPA Code Grp Food Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ 0401005000 4A Amaranth, leafy 32.550000 1.000 1.000 0103015000 1CD Arrowroot, flour 0.080000 1.000 1.000 0103015001 1CD Arrowroot, flour - babyfood 0.080000 1.000 1.000 0103017000 1CD Artichoke, Jerusalem 0.08 0000 1.000 1.000 0401018000 4A Arugula 32.550000 1.000 1.000 0902021000 9B Balsam pear 0.158000 1.000 1.000 1500025000 15 Barley, pearled barley 0.594000 1.000 1.000 1500025001 15 Barley, pearled barley - babyfood 0.594000 1.000 1.000 1500026000 15 Barley, flour 0.594000 1.000 1.000 1500026001 15 Barley, flour - babyfood 0.594000 1.000 1.000 1500027000 15 Barley, bran 0.594000 1.000 1.000 0603030000 6C Bean, black, seed 0.520000 1.000 1.000 0602031000 6B Bean , broad, succulent 0.520000 1.000 1.000 0603032000 6C Bean, broad, seed 0.520000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.520000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.520000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.520000 1.000 1.000 0603038000 6C Bean, lima, seed 0.520000 1.000 1.000 0603039000 6C Bean, mung, seed 0.520000 1.000 1.000 0603040000 6C Bean, navy, seed 0.520000 1.000 1.000 0603041000 6C Bean, pink, seed 0.520000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.520000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.520000 1.000 1.000 0601043001 6A Bean, snap, succulent - babyfood 0.520000 1.000 1.000 3100044000 31 Beef, meat 0.150000 1.000 1.000 3100044001 31 Beef, meat - babyfood 0.150000 1.000 1.000 3100045000 31 Beef, meat, dried 0.150000 1.920 1.000 3100046000 31 Beef, meat byproducts 0.150000 1.000 1.000 3100046001 31 Beef, meat byproducts - babyfood 0.150000 1.000 1.000 3100047000 31 Beef, fat 0.150000 1.000 1.000 3100047001 31 Beef, fat - babyfood 0.150000 1.000 1.000 3100048000 31 Beef, kidney 0.150000 1.000 1.000 3100049000 31 Beef, liver 0.150000 1.000 1.000 3100049001 31 Beef, liver - babyfood 0.150000 1.000 1.000 0101050000 1AB Beet, garden, roots 0.180000 1.000 1.000 0101050001 1AB Beet, garden, roots - babyfood 0.180000 1.000 1.000 0501061000 5A Broccoli 3.270000 1.000 1.000 0501061001 5A Broccoli - babyfood 3.270000 1.000 1.000 0501062000 5A Broccoli, Chinese 3.270000 1.000 1.000 0502063000 5B Broccoli raab 32.990000 1.000 1.000 0501064000 5A Brus sels sprouts 0.740000 1.000 1.000 1500065000 15 Buckwheat 0.594000 1.000 1.000 1500066000 15 Buckwheat, flour 0.594000 1.000 1.000 0101067000 1AB Burdock 0.180000 1.000 1.000 0501069000 5A Cabbage 0.740000 1.000 1.000 0502070000 5B Cabbage, Chinese, bok choy 32.990000 1.000 1.000 0501071000 5A Cabbage, Chinese, napa 0.740000 1.000 1.000Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

Page 12 of 14 0501072000 5A Cabbage, Chinese, mustard 3.270000 1.000 1.000 0901075000 9A Cantaloupe 0.158000 1.000 1.000 0402076000 4B Cardoon 20.160000 1.000 1.000 0101078000 1AB Carrot 0.180000 1.000 1.000 0101078001 1AB Carrot - babyfood 0.180000 1.000 1.000 0101079000 1AB Carrot, juice 0.180000 1.000 1.000 0103082000 1CD Cassava 0.080000 1.000 1.000 0103082001 1CD Cassava - babyfood 0.080000 1.000 1.000 0501083000 5A Cauliflower 3.270000 1.000 1.000 0101084000 1AB Celeriac 0.180000 1.000 1.000 0402085000 4B Celery 20.160000 1.000 1.000 0402085001 4B Celery - babyfood 20.160000 1.000 1.000 0402086000 4B Celery, juice 20.160000 1.000 1.000 0402087000 4B Celtuce 20.160000 1.000 1.000 0902088000 9B Chayote, fruit 0.158000 1.000 1.000 0603098000 6C Chickpea, seed 0.520000 1.000 1.000 0603098001 6C Chickpea, seed - babyfood 0.520000 1.000 1.000 0603099000 6C Chickpea, flour 0.520000 1.000 1.000 0101100000 1AB Chicory, roots 0.180000 1.000 1.000 0902102000 9B Chinese waxgourd 0.158000 1.000 1.000 0401104000 4A Chrysanthemum, garland 32.550000 1.000 1.000 0502117000 5B Coll ards 32.990000 1.000 1.000 1500120000 15 Corn, field, flour 0.218000 1.000 1.000 1500120001 15 Corn, field, flour - babyfood 0.218000 1.000 1.000 1500121000 15 Corn, field, m eal 0.218000 1.000 1.000 1500121001 15 Corn, field, meal - babyfood 0.218000 1.000 1.000 1500122000 15 Corn, field, bran 0.218000 1.000 1.000 1500123000 15 Corn, field, starch 0.218000 1.000 1.000 1500123001 15 Corn, field, starch - babyfood 0.218000 1.000 1.000 1500124000 15 Corn, field, syrup 0.218000 1.000 1.000 1500124001 15 Corn, field, syrup - babyfood 0.218000 1.000 1.000 1500125000 15 Corn, field, oil 0.218000 1.000 1.000 1500125001 15 Corn, field, oil - babyfood 0.218000 1.000 1.000 1500126000 15 Corn, pop 0.594000 1.000 1.000 1500127000 15 Corn, sweet 0.218000 1.000 1.000 1500127001 15 Corn, sweet - babyfood 0.218000 1.000 1.000 2003128000 20C Cottonseed, oil 0.080000 1.000 1.000 2003128001 20C Cottonseed, oil - babyfood 0.080000 1.000 1.000 0401133000 4A Cress, garden 32.550000 1.000 1.000 0401134000 4A Cress, upland 32.550000 1.000 1.000 0902135000 9B Cucumber 0.158000 1.000 1.000 0401138000 4A Dandelion, leaves 32.550000 1.000 1.000 0103139000 1CD Dasheen, corm 0.080000 1.000 1.000 0802148000 8BC Eggplant 0.260000 1.000 1.000 0401150000 4A Endive 32.550000 1.000 1.000 0402152000 4B Fennel, Florence 20.160000 1.000 1.000 0301165000 3A Garlic, bulb 0.186000 1.000 1.000 0301165001 3A Garlic, bulb - babyfood 0.186000 1.000 1.000 0101168000 1AB Ginseng, dried 1.190000 1.000 1.000 3200169000 32 Goat , meat 0.150000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.150000 1.000 1.000 3200171000 32 Goat, fat 0.150000 1.000 1.000 3200172000 32 Goat, kidney 0.150000 1.000 1.000 3200173000 32 Goat, liver 0.150000 1.000 1.000 1304175000 13D Grape 0.896000 1.000 1.000 1304176000 13D Grape, juice 0.896000 1.000 1.000 1304176001 13D Grape, juice - babyfood 0.896000 1.000 1.000 9500177000 O Grape, leaves 0.896000 1.000 1.000 9500178000 O Grape, raisin 0.896000 4.300 1.000 1304179000 13D Grape, wine and sherry 0.896000 1.000 1.000 0603182000 6C Guar, seed 0.520000 1.000 1.000 0603182001 6C Guar, seed - babyfood 0.520000 1.000 1.000 0901187000 9A Honeydew melon 0.158000 1.000 1.000 3300189000 33 Horse, meat 0.150000 1.000 1.000 0101190000 1AB Horseradish 0.180000 1.000 1.000 0502194000 5B Kale 32.990000 1.000 1.000 0501196000 5A Kohlrabi 0.740000 1.000 1.000Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

Page 13 of 14 0302198000 3B Leek 1.234000 1.000 1.000 0603203000 6C Lentil, seed 0.520000 1.000 1.000 0401204000 4A Lettuce, head 11.790000 1.000 1.000 0401205000 4A Lettuce, leaf 17.580000 1.000 1.000 3800221000 38 Meat, game 0.150000 1.000 1.000 3600222000 36 Milk, fat 0.030000 1.000 1.000 3600222001 36 Milk, fat - baby food/infant formu 0.030000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.030000 1.000 1.000 3600223001 36 Milk, nonfat solids - baby food/in 0.030000 1.000 1.000 3600224000 36 Milk, water 0.030000 1.000 1.000 3600224001 36 Milk , water - babyfood/infant form 0.030000 1.000 1.000 3600225001 36 Milk, sugar (lactose) - baby food/ 0.030000 1.000 1.000 1500226000 15 Millet, grain 0.594000 1.000 1.000 0502229000 5B Mustard greens 32.990000 1.000 1.000 1500231000 15 Oat, bran 0.594000 1.000 1.000 1500232000 15 Oat, flour 0.594000 1.000 1.000 1500232001 15 Oat, flour - babyfood 0.594000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 0.594000 1.000 1.000 1500233001 15 Oat, groats/rolled oats - babyfood 0.594000 1.000 1.000 0802234000 8BC Okra 1.780000 1.000 1.000 0301237000 3A Onion, bulb 0.186000 1.000 1.000 0301237001 3A Onion, bulb - babyfood 0.186000 1.000 1.000 0301238000 3A Onion, bulb, dried 0.186000 9.000 1.000 0301238001 3A Onion, bulb, dried - babyfood 0.186000 9.000 1.000 0302239000 3B Onion, green 1.234000 1.000 1.000 0401248000 4A Parsley, leaves 32.550000 1.000 1.000 0101250000 1AB Parsley, turnip rooted 0.180000 1.000 1.000 0101251000 1AB Parsnip 0.180000 1.000 1.000 0101251001 1AB Parsnip - babyfood 0.180000 1.000 1.000 0602255000 6B Pea, succulent 0.520000 1.000 1.000 0602255001 6B Pea, succulent - babyfood 0.520000 1.000 1.000 0603256000 6C Pea, dry 0.520000 1.000 1.000 0603256001 6C Pea, dry - babyfood 0.520000 1.000 1.000 0601257000 6A Pea, edible podded, succulent 0.520000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0.520000 1.000 1.000 0602259000 6B Pea, pigeon, succulent 0.520000 1.000 1.000 0802270000 8B Pepper, bell 0.260000 1.000 1.000 0802270001 8B Pepper, bell - babyfood 0.260000 1.000 1.000 0802271000 8B Pepp er, bell, dried 0.260000 1.000 1.000 0802271001 8B Pepper, bell, dried - babyfood 0.260000 1.000 1.000 0802272000 8BC Pepper, nonbell 1.780000 1.000 1.000 0802272001 8BC Pepper, nonbel l - babyfood 1.780000 1.000 1.000 0802273000 8BC Pepper, nonbell, dried 1.780000 1.000 1.000 0103296000 1C Potato, chips 0.080000 1.000 1.000 0103297000 1C Potato, dry (granules/ f lakes) 0.104000 1.000 1.000 0103297001 1C Potato, dry (granules/ flakes) - b 0.104000 1.000 1.000 0103298000 1C Potato, flour 0.104000 1.000 1.000 0103298001 1C Potato, flour - babyfood 0.104000 1.000 1.000 0103299000 1C Potato, tuber, w/peel 0.080000 1.000 1.000 0103299001 1C Potato, tuber, w/peel - babyfood 0.080000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 0.080000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel - babyfood 0.080000 1.000 1.000 0902308000 9B Pumpkin 0.158000 1.000 1.000 0902309000 9B Pumpkin, seed 0.158000 1.000 1.000 3900312000 39 Rabbit, meat 0.150000 1.000 1.000 0401313000 4A Radicchio 11.790000 1.000 1.000 0101314000 1AB Radish, roots 0.180000 1.000 1.000 0101316000 1AB Radish, Oriental, roots 0.180000 1.000 1.000 0502318000 5B Rape greens 32.990000 1.000 1.000 0402322000 4B Rhubarb 20.160000 1.000 1.000 0101327000 1AB Rutabaga 0.180000 1.000 1.000 1500328000 15 Rye, grain 0.594000 1.000 1.000 1500329000 15 Rye, flour 0.594000 1.000 1.000 0101331000 1AB Salsify, roots 0.180000 1.000 1.000 3500339000 35 Sheep, meat 0.150000 1.000 1.000 3500339001 35 Sheep, meat - babyfood 0.150000 1.000 1.000 3500340000 35 Shee p, meat byproducts 0.150000 1.000 1.000Fenamidone Dietary Exposure and Risk Assessment DP Number: D416496

Page 14 of 14 3500341000 35 Sheep, fat 0.150000 1.000 1.000 3500341001 35 Sheep, fat - babyfood 0.150000 1.000 1.000 3500342000 35 Sheep, kidney 0.150000 1.000 1.000 3500343000 35 Sheep, liver 0.150000 1.000 1.000 1500344000 15 Sorghum, grain 0.594000 1.000 1.000 1500345000 15 Sorghum, syrup 0.594000 1.000 1.000 0600347000 6 Soybean, seed 0.232000 1.000 1.000 0603348000 6C Soybean, flour 0.232000 1.000 1.000 0603348001 6C Soybean, flour - babyfood 0.232000 1.000 1.000 0600349000 6 Soybean, soy milk 0.232000 1.000 1.000 0600349001 6 Soybean, soy milk - babyfood or in 0.232000 1.000 1.000 0600350000 6 Soybean, oil 0.232000 1.000 1.000 0600350001 6 Soybean, oil - babyfood 0.232000 1.000 1.000 0401355000 4A Spinach 32.550000 1.000 1.000 0401355001 4A Spinach - babyfood 32.550000 1.000 1.000 0902356000 9B Squash, summer 0.158000 1.000 1.000 0902356001 9B Squash, summer - babyfood 0.158000 1.000 1.000 0902357000 9B Squash, winter 0.158000 1.000 1.000 0902357001 9B Squash, winter - babyfood 0.158000 1.000 1.000 1307359000 13G Strawberry 0.252000 1.000 1.000 1307359001 13G Strawberry - babyfood 0.252000 1.000 1.000 1307360000 13G Strawberry, juice 0.252000 1.000 1.000 1307360001 13G Strawberry, juice - babyfood 0.252000 1.000 1.000 2002364000 20B Sunflower, seed 0.080000 1.000 1.000 2002365000 20B Sunflower, oil 0.080000 1.000 1.000 2002365001 20B Sunflower, oil - babyfood 0.080000 1.000 1.000 0103366000 1CD Sweet potato 0.080000 1.000 1.000 0103366001 1CD Swee t potato - babyfood 0.080000 1.000 1.000 0402367000 4B Swiss chard 20.160000 1.000 1.000 0103371000 1CD Tanier, corm 0.080000 1.000 1.000 0801374000 8A Tomatillo 0.860000 1.000 1.000 0801375000 8A Tomato 0.860000 1.000 1.000 0801375001 8A Tomato - babyfood 0.860000 1.000 1.000 0801376000 8A Tomato, paste 2.880000 1.000 1.000 0801376001 8A Tomato, paste - babyfood 2.880000 1.000 1.000 0801377000 8A Tomato, puree 1.779000 1.000 1.000 0801377001 8A Tomato, puree - babyfood 1.779000 1.000 1.000 0801378000 8A Tomato, dried 0.860000 14.300 1.000 0801378001 8A Tomato, dried - babyfood 0.860000 14.300 1.000 0801379000 8A Tomato, juice 0.860000 1.500 1.000 1500381000 15 Triticale, flour 0.594000 1.000 1.000 1500381001 15 Triticale, flour - babyfood 0.594000 1.000 1.000 0103387000 1CD Turmeric 0.080000 1.000 1.000 0101388000 1AB Turnip, roots 0.180000 1.000 1.000 0502389000 5B Turnip, greens 32.990000 1.000 1.000 8601000000 86A Water, direct, all sources 0.207000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.207000 1.000 1.000 0901399000 9A Watermelon 0.158000 1.000 1.000 0901400000 9A Watermelon, juice 0.158000 1.000 1.000 1500401000 15 Wheat, grain 0.594000 1.000 1.000 1500401001 15 Wheat, grain - babyfood 0.594000 1.000 1.000 1500402000 15 Wheat, flour 0.594000 1.000 1.000 1500402001 15 Wheat, flour - babyfood 0.594000 1.000 1.000 1500403000 15 Wheat, germ 0.594000 1.000 1.000 1500404000 15 Wheat, bran 0.594000 1.000 1.000 0103406000 1CD Yam, true 0.080000 1.000 1.000 0103407000 1CD Yam bean 0.080000 1.000 1.000 0301338000 3A Shallot, bulb 0.186000 1.000 1.000