                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, 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 (Subgroup 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 (7508P)

THROUGH:	 Dennis McNeilly, Chemist
	Meheret Negussie, Chemist
	Ideliz 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 Survey, What We Eat in America, (NHANES/WWEIA).The analyses 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 Assessment

 A slightly unrefined acute dietary risk assessment was conducted which used maximum field trial residue values, assumed 100 percent crop treated (% CT) for all commodities, incorporated DEEM(TM) default processing factors and empirical factors were used for 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 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 DEEM(TM) 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 highly exposed subpopulation was children 1  -  2 years with an estimated exposure equivalent to 89% of the cPAD.

Cancer Dietary Exposure Assessment 

Fenamidone is not likely to be a human carcinogen; therefore a cancer dietary risk assessment is not required for this chemical.  

I.  Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the 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-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million.  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-2013, web link:  http://www.epa.gov/fedrgstr/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 (D391040, 07/7/11).

II.  Residue Information

Tolerances are currently 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 vegetables, cotton, non bell pepper, sunflower, and tomato ranging from 0.02 ppm to 60 ppm.  Livestock commodity tolerances are established for residues of fenamidone and RPA 717879 (DADK-Fen) in milk, fat, meat and meat byproducts under 180.579(a)(2).  Rotational crop tolerances are established for residues of fenamidone and RPA 717870 (DADK-Fen) in wheat, corn and soybean 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 risk 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 fenamidone, 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 document (K. Milians, D409835). 

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 metabolism 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 residues of parent fenamidone were 0.35 ppm, conjugated RPA 408056 were 0.024 ppm, RPA 717879  were <0.02 and RPA 405862 were 0.022 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).
Snap Beans
                                     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, RPA 405862, RPA 717879, RPA 408056 in snap beans were 0.46, 0.02, 0.02 and 0.02 ppm, respectively, for a total residue of 0.52 ppm (MRID 49052103; 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 3-07B
                                     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 soybean processed commodities.  For these commodities, the DEEM (ver. 7.81) default 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).


III.  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 Fate and Effects Division (EFED, J. K. Wolf, D409837, 09/18/13) and were incorporated directly 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 Screening Concentration In Ground Water 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 PCA 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 risk assessment are those estimated for groundwater.  The highest daily total fenamidone residue concentration in shallow groundwater estimated by PRZM-GW is 207ug/L and the average concentration after breakthrough was 139 ug/L for the Central Sands Region of Wisconsin from 30 years of continuous use.  These estimates represent potential exposure to private drinking water well in a highly vulnerable pesticide use area where numerous pesticide residues have been detected in groundwater.

For both the acute and chronic dietary analysis, 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
Acute
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 days.  Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups.  However, for acute exposure assessment, consumption data are retained as individual consumption events.  Based on analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years old.

For 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 daily consumption estimate for that food/food form to produce a residue intake estimate.  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 basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or "matched" in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., 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 policy, per capita exposure and risk are reported for analyses performed at all levels of refinement.  However, for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specifically 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 database 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 the dietary analyses, HED concludes that the FQPA Safety 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 SF
RfD and PAD
Study and Toxicological Effects
Acute Dietary
(All populations)
NOAEL = 125 mg/kg/day
UFA= 10x
UFH= 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
UFA= 10x
UFH= 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 adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (intraspecies).  UFH = 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.  


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(TM) analyses 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 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 new uses of fenamidone resulted in an estimated risk equivalent to 53% of the cPAD.  The most highly exposed subpopulation was children 1  -  2 years with an estimated exposure equivalent to 89 % of the cPAD.

 The results of the acute and chronic dietary exposure analysis are reported in the summary table below (Table 4).  

Fenamidone is not likely 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 Fenamidone
                              Population Subgroup
                                 Acute Dietary
                               (95th Percentile)
                                Chronic Dietary
                                     Cancer
                                        
                          Dietary Exposure (mg/kg/day)
                                    % aPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                    % cPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                      Risk
 General U.S. Population
                                    0.042858
                                      3.4
                                    0.014881
                                       53
                                      N/A
                                      N/A
 All Infants (< 1 year old)
                                    0.049122
                                      3.9
                                    0.019601
                                       69
                                        
                                        
 Female 13-50 years old
                                    0.044191
                                      3.5
                                    0.014513
                                       51
                                        
                                        
 Children 1-2 years old
                                    0.059469
                                      4.8
                                    0.025185
                                       89
                                        
                                        
 Children 3-5 years old
                                    0.058441
                                      4.7
                                    0.022511
                                       80
                                        
                                        
 Children 6-12 years old
                                    0.035464
                                      2.8
                                    0.014602
                                       52
                                        
                                        
 Youth 13-19 years old
                                    0.030767
                                      2.5
                                    0.011064
                                       39
                                        
                                        
 Adults 20-49 years old
                                    0.042344
                                      3.4
                                    0.014350
                                       51
                                        
                                        
 Adults 50+ years old
                                    0.043906
                                      3.5
                                    0.014768
                                       52
                                        
                                        
 Females 13-49 years old
                                    0.044264
                                      3.5
                                    0.014516
                                       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 concentration factors and empirical factors.  The results of the acute and chronic dietary risk assessments are unlikely to underestimate 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 DEEM(TM) 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 new uses of fenamidone resulted in an estimated risk equivalent to 53% of the cPAD.  The most highly 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 newly 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-d
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 11-19-2013/12:08:00     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%
Female 13-49                                0.014516                51.3%

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

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    Residue 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    2.46    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     823  




Attachment 3.  Acute and Chronic Food plus Water Residue Input file.

The residue input file used was the same for acute and chronic analyses, however the reference doses were different; 0.0283 mg/kg  bw/day for chronic analysis and 125 mg/kg  bw/day for acute.

US EPA                                                          Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for FENAMIDONE
Residue file: 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: 11-19-2013/13:26:57
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               0.080000   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   Brussels 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      1.000   
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   Collards                          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, meal                  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      1.000   
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   Pepper, 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, nonbell-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/ flakes)     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   Sheep, meat byproducts             0.150000   1.000      1.000   
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  Sweet 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   



