

                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                                                               
                                         OFFICE OF CHEMICAL SAFETY             
                                                      AND POLLUTION PREVENTION 



MEMORANDUM

Date:  		9/7/2012

SUBJECT:	Fluazinam  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Soybeans, the Melon Subgroup (9A), and the Pepper/Eggplant Subgroup (8-10B)


PC Code:  129098
DP Barcode:  D397722
Decision Nos.:  459107
Registration No.: 71512-1
Petition:  1E7959, 2F7977
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  Dietary
Case No.:  7013
TXR No.:  NA
CAS No.:  79622-59-6
MRID No.:  NA
40 CFR:  §180.574


		              									
FROM:  	Douglas Dotson, Ph.D., Chemist
		Risk Assessment Branch II
		Health Effects Division (7509P)	
		
THROUGH:	Nancy Dodd, Chemist
		Ideliz Negrón-Encarnación, Ph.D., Chemist
		Dietary Exposure Science Advisory Council
		
      and
		
      Christina Swartz, Branch Chief
		Risk Assessment Branch II
		Health Effects Division (7509P)

TO:		Andrew Ertman/Barbara Madden, RM Team 5, RIMUERB
		Dominic Schuler/Tony Kish, PM Team 22, Fungicide Branch
		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 DEEM-FCID, Version 3.16 which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  This dietary survey was conducted from 2003 to 2008.  The analyses were conducted as part of a human health risk assessment for the proposed use of fluazinam on soybeans, the melon subgroup (9B) and the pepper/eggplant subgroup (8-10B).  The estimated drinking water concentrations (EDWCs) are based on a currently registered use on turf.
 
The acute analysis is based on tolerance-level residues for all commodities and uses high-end residue estimates for the metabolite AMGT.  In addition, the acute assessment assumes 100% crop treated and incorporates modeled estimated drinking water concentrations (EDWCs) that account for both parent fluazinam and its transformation products.  Therefore, the resulting exposure and risk estimates are considered to be very conservative.  The acute risk estimates at the 95[th] percentile of exposure are below HED's level of concern for all population subgroups, including those comprised of infants and children.  Generally, HED is concerned when risk estimates exceed 100% of the population-adjusted dose (PAD).  The acute risk estimate for the general U.S. population is 5.3% of the acute PAD (aPAD).  The population subgroup with the highest acute dietary risk estimate is Females 13-49, which uses 28% of the aPAD.

The chronic analysis is based on tolerance-level residues for all commodities except apples.  For apples, the average field trial value was used.  As with the acute assessment, it assumes high-end estimates for AMGT, 100% crop treated, and incorporates modeled EDWCs that account for both parent and transformation products.  The resulting exposure and risk estimates are considered to be conservative.  Chronic risk estimates are below HED's level of concern for all population subgroups.  The risk estimate for the general U.S. population is 20% of the chronic PAD (cPAD).  The most highly exposed population subgroup is Children 1-2, which uses 51% of the cPAD.

Fluazinam is classified as having "suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential."  The CARC determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to fluazinam.  As a result, the chronic dietary exposure assessment is protective for potential cancer risk.

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 the point of departure (e.g., POD, NOAEL, or LOAEL) 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.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  "Available Information on Assessing Exposure from Pesticides, A User's Guide," 21 Jun 2000, web link:  http://www.epa.gov/ fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20 Aug 1999).  The most recent dietary risk assessment for fluazinam was conducted by D. Dotson (D394960, 2/7/2012).

II.   Residue Information

Fluazinam is currently registered in the U.S. for use on carrots, potatoes, ginseng, the Bulb onion subgroup (3-07A), head lettuce, leaf lettuce, Crop Group 5 (Brassica leafy vegetables), turnip greens, peanuts, apples, the Bushberry subgroup (13-07B), and Crop subgroups 6-A (except pea), 6-B (except pea), and 6-C (except pea).  In addition, there is a tolerance without U.S. registration on wine grapes.  Tolerances for these commodities range from 0.01 ppm for the Brassica leafy vegetables and turnip greens to 7.0 ppm for the Bushberry subgroup.  Tolerances have also been established for residues in the fat and meat byproducts of cattle, goats, horses, and sheep.  The tolerances for fluazinam are listed in 40 CFR 180.574.

The metabolite AMGT is a residue of concern for some commodities, but not for others.  The residue of concern for risk assessment in peanuts, bulb vegetables, and root and tuber vegetables is parent fluazinam.  For all other plant commodities, the residues of concern in plants for risk assessment are fluazinam and its metabolite AMGT.  In the crop field trials that were performed, AMGT was measured in some commodities but not in others.  As a result, the residue levels that were used in the dietary exposure assessments were determined in different ways.

As the residue of concern in peanuts, bulb vegetables, and root and tuber vegetables is parent only, tolerance-level residues were used for these commodities.

For the commodities in the current tolerance petitions (soybeans, cantaloupe, and peppers), residues of parent fluazinam as well as residues of AMGT were measured in the field trial studies.  For these commodities, the LOQ for AMGT was 0.01 ppm.  All samples had residue levels below the LOQ.  As a result, the total residue used in the dietary exposure assessment was the tolerance plus 0.01 ppm.  Both fluazinam and AMGT were also measured in the grape and apple field trials.  The 3.0 ppm tolerance for grapes covers all residues of concern.  The fluazinam apple tolerance is 2.0 ppm, and the highest combined (fluazinam + AMGT) residue is below the tolerance (1.69 ppm).  The tolerance was used in the acute assessment and the average combined (fluazinam + AMGT) residue value of 0.215 ppm was used in the chronic assessment.     

For bushberries, the mean ratio of the metabolite:parent residues (0.11:1) from field trials was used to estimate the total residues of concern, and the bushberry tolerance of 7.0 ppm was multiplied by a factor of 1.11.

For the other commodities, an upper-bound ratio of 0.35:1 (AMGT:fluazinam) was used to estimate the AMGT residue.  This factor is the maximum AMGT:fluazinam ratio in grapes determined in the grape metabolism study.  The values obtained using this ratio were used in both the acute and chronic assessments.  For more information concerning the residue levels used in the dietary exposure assessments, see the last dietary exposure memos that were written for fluazinam (D276982, W. Cutchin, 8/22/2001; D340854, M. Doherty, 8/1/2007; and D374522, D. Dotson, 3/31/2010).  

In livestock commodities, the residues of concern for risk assessment and tolerance enforcement are the same:  parent fluazinam, its metabolites AMPA and DAPA, and their sulfamate conjugates.  The tolerance level of 0.05 ppm is being used for meat byproducts and fat of cattle, goats, horses, and sheep (Memo, D360840, D. Dotson, 3/31/2010).  This value is very conservative because it accounts for all residues of concern in the livestock commodities for which tolerances have been established.

DEEM 7.81 default processing factors were used for all processed commodities for which they were available.  Full listings of the residue inputs used in the analyses are included as Attachments 1 and 3.

Table 1.  Summary of Crop Residue Levels Used in the Acute and Chronic
       Dietary Exposure Analyses
Crop/Crop Group
                                Tolerance Level
                                     (ppm)
                    Residue Level used in Assessments (ppm)
                                 Derivation of
                                 Residue Level
Carrots
0.70
0.70
                            Tolerance (parent only)
Potatoes
0.02
0.02
                            Tolerance (parent only)
Ginseng
4.5
4.5
                            Tolerance (parent only)
Bulb Onions (Subgroup 3-07A)
0.20
0.20
                            Tolerance (parent only)
Head Lettuce
0.02
0.027
0.02 tolerance x 1.35
Leaf Lettuce
2.0
2.7
2.0 tolerance x 1.35
Brassica Leafy Vegetables
0.01
0.0135
0.01 tolerance x 1.35
Turnip Greens
0.01
0.0135
0.01 tolerance x 1.35
Edible-Podded Legumes, Subgroup 6-A, except pea
0.10
0.135
0.1 tolerance x 1.35
Succulent Shelled Legumes, Subgroup 6-B, except pea
0.04
0.054
                             0.04 tolerance x 1.35
Dried Shelled Legumes, Subgroup 6-C, except pea
0.02
0.027
                             0.02 tolerance x 1.35
Soybean
0.01
0.02
                               Tolerance + 0.01
Peanuts
0.02
0.02
                            Tolerance (parent only)
Peppers/Eggplant (8-10B)
0.09
0.10
                               Tolerance + 0.01
Melons (9A)
0.07
0.08
                               Tolerance + 0.01
Apples (Acute Assessment)
2.0
2.0
                      Tolerance includes parent and AMGT
Apples (Chronic Assessment)
2.0
0.215 
                    Avg combined residue (fluazinam + AMGT)
Bushberry Subgroup 13-07B
7.0
7.8
                               Tolerance x 1.11
Wine Grapes (imported)
3.0
3.0
                      Tolerance includes parent and AMGT
Fat of cattle, goat, horse, and sheep
0.05
0.05
                                   Tolerance
Meat byproducts of cattle, goat, horse, and sheep 
0.05
0.05
                                   Tolerance

Residues in Fish

Tolerances have not been established for fish commodities.  Fluazinam has a low water solubility and a relatively high octanol/water partition coefficient.  As a result, it will not dissolve in water to any significant extent.  Residues have the potential to partition into sediment at the bottoms of water bodies, however.  Catfish are bottom feeders and residues in catfish serve as a marker for pesticide residues.  The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010.  The catfish samples were not analyzed for fluazinam, however.  As a result, residues in fish were not included in the dietary exposure assessments. 


III.   Percent Crop Treated Information

The acute and chronic assessments were both based on the assumption that 100% of all commodities with fluazinam tolerances will be treated.


IV.   Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED; D391184, J. Meléndez, 8/3/2011) and incorporated directly into this dietary assessment into the food categories "water, direct, all sources" and "water, indirect, all sources."  The residues of concern in drinking water for risk assessment are parent fluazinam and its transformation products, including DCPA, CAPA, DAPA, HYPA, and AMPA.

The estimated acute and chronic EDWCs are based on ground application of fluazinam to turf.  The values are provided in Table 2, below.  The groundwater value was generated using the Screening Concentration in Groundwater (SCI-GROW) Model and the surface water values were generated using the FQPA Index Reservoir Screening Tool (FIRST) Model.  The surface water estimates were used for both the acute and chronic assessments because they were higher than the groundwater value.  Both acute and chronic estimates included parent and degradates.  For the acute assessment, a value of 226 ppb was used, and for the chronic assessment, a value of 37.8 ppb was used.  This value also includes both parent and degradates.  For more information about EFED's drinking water models, see http://www.epa.gov/oppefed1/models/ water.


Table 2.  Maximum Tier 1 Estimated Drinking Water Concentrations Based on Ground
        Application of Fluazinam to Turf at a Seasonal Rate of 8.4 lb a.i./A
                                 Source/Model
                                   Fluazinam
                        Total Residues of Fluazinam[1]
                                       
                                   Acute/ppb
                                  Chronic/ppb
                                   Acute/ppb
                                  Chronic/ppb
                              Surface Water/FIRST
                                     217 2
                                     1.47
                                     226 2
                                     37.8
                             Groundwater/SCI-GROW
                                     0.404
1. Including the following transformation products: DCPA, HYPA, CAPA, DAPA, and AMPA.
[2][.] Exceeds the solubility of fluazinam at pH 7 (71 ppb), but not the solubility at pH 11 (350 ppm).


V.   DEEM-FCID Program and Consumption Information

Fluazinam acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, Version 3.16, which incorporates consumption data from USDA's NHANES/WWEIA.  This dietary survey was conducted from 2003 to 2008.  The data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using 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 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 acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or "matched" in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., 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 assessments performed at all levels of refinement.  However, for unrefined 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 toxicity data show that the primary target organ for chronic exposure to fluazinam is the liver.  Liver effects in mice served as the basis for the chronic dietary endpoint.  Acute neurotoxicity was seen in rats, and developmental toxicity was seen in rabbits.  For acute dietary exposure assessment, different endpoints were selected for the general U.S. population and Females 13-49.  The FQPA Safety Factor was reduced to 1x for all population subgroups.  The CARC determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to fluazinam.  The fluazinam doses and endpoints for use in dietary exposure assessments are summarized in Table 3.

Table 3.  Toxicological Doses and Endpoints for Fluazinam for Use in Dietary and Non-Occupational Human Health Risk Assessments
Exposure/
Scenario
Point of Departure
Uncertainty/
FQPA Safety Factors
RfD, PAD, Level of Concern for Risk Assessment
Study and Toxicological Effects
Acute Dietary (General population)
NOAEL= 50 mg/kg/day

UFA= 10x
UFH=10x
FQPA SF=1x

Acute RfD =0.5 mg/kg/day

aPAD
= 0.5mg/kg/day
Acute Neurotoxicity-Rats
LOAEL = 1000 mg/kg/day based on decreased motor activity and soft stools on day of dosing. 
Acute Dietary
(Females 13-49 years of age)
NOAEL (developmental) = 7 mg/kg/day
UFA= 10x
UFH=10x
FQPA SF=1x

Acute RfD =0.07 mg/kg/day

aPAD
= 0.07mg/kg/day
Developmental Toxicity- Rabbits
Developmental LOAEL = 12 mg/kg/day based on increased incidence of total litter resorptions and possibly increased incidence of fetal skeletal abnormalities.
Chronic Dietary (All Populations)
NOAEL= 1.1 mg/kg/day

UFA= 10x
UFH=10x
FQPA SF=1x

Chronic RfD =0.011 mg/kg/day

cPAD
= 0.011mg/kg/day
Carcinogenicity-Mice
LOAEL = 10.7 mg/kg/day based on liver histopathology and increased liver weight.  
Cancer (oral, dermal, inhalation)
Classification: "Suggestive Evidence of Carcinogenicity, but not sufficient to assess human carcinogenic potential."
	NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies). 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 50-99 years.  Risk estimates are below HED's level of concern for all population subgroups in both the acute and chronic analyses.  The acute risk estimate for the general U.S. population is 5.3% of the aPAD.  The population subgroup with the highest acute risk estimate is Females 13-49, which uses 28% of the aPAD.  Although Females 13-49 use the greatest percent of the aPAD, the population subgroup with the highest exposure is Children 1-2.  Children 1-2 uses 21% of the aPAD.  The reason this subgroup has a higher exposure but a lower % aPAD value than Females 13-49 is that it has a higher aPAD value than Females 13-49 (0.5 mg/kg/day for Children 1-2 as opposed to 0.07 mg/kg/day for Females 13-49).
The chronic risk estimate for the general U.S. population is 20% of the cPAD.  The most highly exposed population subgroup is Children 1-2, which uses 51% of the cPAD.  Finally, cancer risk is not of concern.

 Full listings of exposure and risk estimates are included in Attachments 2 (acute analysis) and 4 (chronic analysis).
 
 Table 4.  Summary of Acute and Chronic Exposure and Risk Estimates for Fluazinam
                              Population Subgroup
                      Acute Assessment (95[th] Percentile)
                               Chronic Assessment
 
                                aPAD, mg/kg/day
                          Exposure Estimate, mg/kg/day
                                     % aPAD
                                cPAD, mg/kg/day
                          Exposure Estimate, mg/kg/day
                                     % cPAD
U.S. Population
0.5
0.026393
5.3
                                     0.011
0.002145
20
All infants
0.5
0.083776
17
                                     0.011
0.004928
45
Children 1-2 yrs*
0.5
0.106710
21
                                     0.011
0.005635
51
Children 3-5 yrs
0.5
0.064022
13
                                     0.011
0.003751
34
Children 6-12 yrs
0.5
0.031323
6.3
                                     0.011
0.002031
18
Youth 13-19 yrs
0.5
0.017332
3.5
                                     0.011
0.001171
11
Adults 20-49 yrs
0.5
0.019148
3.8
                                     0.011
0.001936
18
Adults 50-99 yrs
0.5
0.017495
3.5
                                     0.011
0.002118
19
Females 13-49 yrs*
0.07
0.019721
28
                                     0.011
0.001996
18
 *The subpopulation with the highest acute or chronic risk estimate
 
 
 VIII.   Characterization of Inputs/Outputs
 
HED considers both the acute and chronic assessments to be very conservative.  The acute assessment is based on tolerance-level residues for all commodities, with worst-case assumptions being made for residue levels of the metabolite AMGT.  In addition, it was assumed that 100% of all crops with registered or requested uses of fluazinam will be treated.  The EDWCs include parent fluazinam and its transformation products.  The assumption was made that the degradates were as toxic as parent fluazinam.  These same assumptions and inputs were used for the chronic assessment, except that an average field trial value was used for apples.  These assumptions result in highly conservative, health-protective estimates of exposure and risk.  In the event that refinements need to be made in the future, percent crop treated estimates, average field trial values, and monitoring data can be incorporated into the assessments.


 IX.   Conclusions
 
 The exposure estimates generated by the dietary exposure model that was used are conservative estimates of dietary exposure.  Even so, the acute and chronic aggregate (food + drinking water) dietary risk estimates for the general U.S. population and all population subgroups are not of concern.  The chronic dietary exposure assessment is protective for cancer.  Cancer risk is also not of concern.  
 
 
 X.   List of Attachments
 
Attachment 1.  Acute Dietary Residue Input File for Fluazinam
Attachment 2.  Results of Acute Dietary Exposure Assessment
 Attachment 3.  Chronic Dietary Residue Input File for Fluazinam
 Attachment 4.  Results of Chronic Dietary Exposure Assessment


Attachment 1:  Acute Dietary Residue Input File for Fluazinam

DEEM FCID Version 3.16

Acute NOAEL for general population including infants and children:  50 mg/kg bw/day
Acute PAD for general population including infants and children:  0.5 mg/kg bw/day

Acute NOAEL for Females 13-49:  7 mg/kg bw/day
Acute PAD for Females 13-49:  0.07 mg/kg bw/day

Filename: C:\Documents and Settings\ddotson\My Documents\DEEM FCID\Fluazinam\
                 Fluazinam2012acute.R08
Date created/last modified: 07-14-2012/11:50:12


-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2   
---------- ---- -------------------------------  ----------  ------ ------  -------
0101078000 1AB  Carrot                             0.700000   1.000  1.000  
0101078001 1AB  Carrot-babyfood                    0.700000   1.000  1.000  
0101079000 1AB  Carrot, juice                      0.700000   1.000  1.000  
0101168000 1AB  Ginseng, dried                     4.500000   1.000  1.000  
0103296000 1C   Potato, chips                      0.020000   1.000  1.000  
0103297000 1C   Potato, dry (granules/ flakes)     0.020000   6.500  1.000  
0103297001 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500  1.000  
0103298000 1C   Potato, flour                      0.020000   6.500  1.000  
0103298001 1C   Potato, flour-babyfood             0.020000   6.500  1.000  
0103299000 1C   Potato, tuber, w/peel              0.020000   1.000  1.000  
0103299001 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000  
0103300000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000  
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000  
0301165000 3A   Garlic, bulb                       0.200000   1.000  1.000  
0301165001 3A   Garlic, bulb-babyfood              0.200000   1.000  1.000  
0301237000 3A   Onion, bulb                        0.200000   1.000  1.000  
0301237001 3A   Onion, bulb-babyfood               0.200000   1.000  1.000  
0301238000 3A   Onion, bulb, dried                 0.200000   9.000  1.000  
0301238001 3A   Onion, bulb, dried-babyfood        0.200000   9.000  1.000  
0302338500 3B   Shallot, fresh leaves              0.200000   1.000  1.000  
0401204000 4A   Lettuce, head                      0.027000   1.000  1.000  
0401205000 4A   Lettuce, leaf                      2.700000   1.000  1.000  
0501061000 5A   Broccoli                           0.013500   1.000  1.000  
0501061001 5A   Broccoli-babyfood                  0.013500   1.000  1.000  
0501062000 5A   Broccoli, Chinese                  0.013500   1.000  1.000  
0501064000 5A   Brussels sprouts                   0.013500   1.000  1.000  
0501069000 5A   Cabbage                            0.013500   1.000  1.000  
0501071000 5A   Cabbage, Chinese, napa             0.013500   1.000  1.000  
0501072000 5A   Cabbage, Chinese, mustard          0.013500   1.000  1.000  
0501083000 5A   Cauliflower                        0.013500   1.000  1.000  
0501196000 5A   Kohlrabi                           0.013500   1.000  1.000  
0502063000 5B   Broccoli raab                      0.013500   1.000  1.000  
0502070000 5B   Cabbage, Chinese, bok choy         0.013500   1.000  1.000  
0502117000 5B   Collards                           0.013500   1.000  1.000  
0502194000 5B   Kale                               0.013500   1.000  1.000  
0502229000 5B   Mustard greens                     0.013500   1.000  1.000  
0502318000 5B   Rape greens                        0.013500   1.000  1.000  
0502389000 5B   Turnip, greens                     0.013500   1.000  1.000  
0600347000 6    Soybean, seed                      0.020000   1.000  1.000  
0600349000 6    Soybean, soy milk                  0.020000   1.000  1.000  
0600349001 6    Soybean, soy milk-babyfood or in   0.020000   1.000  1.000  
0600350000 6    Soybean, oil                       0.020000   1.000  1.000  
0600350001 6    Soybean, oil-babyfood              0.020000   1.000  1.000  
0601043000 6A   Bean, snap, succulent              0.135000   1.000  1.000  
0601043001 6A   Bean, snap, succulent-babyfood     0.135000   1.000  1.000  
0602031000 6B   Bean, broad, succulent             0.054000   1.000  1.000  
0602033000 6B   Bean, cowpea, succulent            0.054000   1.000  1.000  
0602037000 6B   Bean, lima, succulent              0.054000   1.000  1.000  
0603030000 6C   Bean, black, seed                  0.027000   1.000  1.000  
0603032000 6C   Bean, broad, seed                  0.027000   1.000  1.000  
0603034000 6C   Bean, cowpea, seed                 0.027000   1.000  1.000  
0603035000 6C   Bean,  great northern, seed        0.027000   1.000  1.000  
0603036000 6C   Bean, kidney, seed                 0.027000   1.000  1.000  
0603038000 6C   Bean, lima, seed                   0.027000   1.000  1.000  
0603039000 6C   Bean, mung, seed                   0.027000   1.000  1.000  
0603040000 6C   Bean, navy, seed                   0.027000   1.000  1.000  
0603041000 6C   Bean, pink, seed                   0.027000   1.000  1.000  
0603042000 6C   Bean, pinto, seed                  0.027000   1.000  1.000  
0603098000 6C   Chickpea, seed                     0.027000   1.000  1.000  
0603098001 6C   Chickpea, seed-babyfood            0.027000   1.000  1.000  
0603099000 6C   Chickpea, flour                    0.027000   1.000  1.000  
0603182000 6C   Guar, seed                         0.027000   1.000  1.000  
0603182001 6C   Guar, seed-babyfood                0.027000   1.000  1.000  
0802148000 8BC  Eggplant                           0.100000   1.000  1.000  
0802234000 8BC  Okra                               0.100000   1.000  1.000  
0802270000 8B   Pepper, bell                       0.100000   1.000  1.000  
0802270001 8B   Pepper, bell-babyfood              0.100000   1.000  1.000  
0802271000 8B   Pepper, bell, dried                0.100000   1.000  1.000  
0802271001 8B   Pepper, bell, dried-babyfood       0.100000   1.000  1.000  
0802272000 8BC  Pepper, nonbell                    0.100000   1.000  1.000  
0802272001 8BC  Pepper, nonbell-babyfood           0.100000   1.000  1.000  
0802273000 8BC  Pepper, nonbell, dried             0.100000   1.000  1.000  
0901075000 9A   Cantaloupe                         0.080000   1.000  1.000  
0901187000 9A   Honeydew melon                     0.080000   1.000  1.000  
0901399000 9A   Watermelon                         0.080000   1.000  1.000  
0901400000 9A   Watermelon, juice                  0.080000   1.000  1.000  
1100007000 11   Apple, fruit with peel             2.000000   1.000  1.000  
1100008000 11   Apple, peeled fruit                2.000000   1.000  1.000  
1100008001 11   Apple, peeled fruit-babyfood       2.000000   1.000  1.000  
1100009000 11   Apple, dried                       2.000000   8.000  1.000  
1100009001 11   Apple, dried-babyfood              2.000000   8.000  1.000  
1100010000 11   Apple, juice                       2.000000   1.300  1.000  
1100010001 11   Apple, juice-babyfood              2.000000   1.300  1.000  
1100011000 11   Apple, sauce                       2.000000   1.000  1.000  
1100011001 11   Apple, sauce-babyfood              2.000000   1.000  1.000  
1302057000 13B  Blueberry                          7.800000   1.000  1.000  
1302057001 13B  Blueberry-babyfood                 7.800000   1.000  1.000  
1302136000 13B  Currant                            7.800000   1.000  1.000  
1302137000 13B  Currant, dried                     7.800000   1.000  1.000  
1302149000 13B  Elderberry                         7.800000   1.000  1.000  
1302174000 13B  Gooseberry                         7.800000   1.000  1.000  
1302191000 13B  Huckleberry                        7.800000   1.000  1.000  
1304179000 13D  Grape, wine and sherry             3.000000   1.000  1.000  
3100046000 31   Beef, meat byproducts              0.050000   1.000  1.000  
3100046001 31   Beef, meat byproducts-babyfood     0.050000   1.000  1.000  
3100047000 31   Beef, fat                          0.050000   1.000  1.000  
3100047001 31   Beef, fat-babyfood                 0.050000   1.000  1.000  
3100048000 31   Beef, kidney                       0.050000   1.000  1.000  
3100049000 31   Beef, liver                        0.050000   1.000  1.000  
3100049001 31   Beef, liver-babyfood               0.050000   1.000  1.000  
3200170000 32   Goat, meat byproducts              0.050000   1.000  1.000  
3200171000 32   Goat, fat                          0.050000   1.000  1.000  
3200172000 32   Goat, kidney                       0.050000   1.000  1.000  
3200173000 32   Goat, liver                        0.050000   1.000  1.000  
3500340000 35   Sheep, meat byproducts             0.050000   1.000  1.000  
3500341000 35   Sheep, fat                         0.050000   1.000  1.000  
3500341001 35   Sheep, fat-babyfood                0.050000   1.000  1.000  
3500342000 35   Sheep, kidney                      0.050000   1.000  1.000  
3500343000 35   Sheep, liver                       0.050000   1.000  1.000  
8601000000 86A  Water, direct, all sources         0.226000   1.000  1.000  
8602000000 86B  Water, indirect, all sources       0.226000   1.000  1.000  
9500263000 O    Peanut                             0.020000   1.000  1.000  
9500264000 O    Peanut, butter                     0.020000   1.890  1.000  
9500265000 O    Peanut, oil                        0.020000   1.000  1.000  



Attachment 2:  Results of Acute Dietary Exposure Assessment

Residue file:  Fluazinam2012acute.R08
Analysis Date:  07-14-2012/13:18:43
Residue file dated:  07-14-2012/13:14:55

Acute PAD for general population including infants and children:  0.5 mg/kg bw/day
Acute PAD for Females 13-49:  0.07 mg/kg bw/day


===============================================================================

Summary calculations--per capita:

                   95th Percentile      99th Percentile     99.9th Percentile
                   Exposure   % aPAD    Exposure   % aPAD    Exposure   % aPAD 
                  ---------- --------  ---------- --------  ---------- --------
US Population:      0.026393     5.28    0.061603    12.32    0.149939    29.99 

All Infants:        0.083776    16.76    0.147293    29.46    0.211463    42.29 

Children 1-2:       0.106710    21.34    0.189491    37.90    0.308126    61.63 

Children 3-5:       0.064022    12.80    0.115100    23.02    0.175905    35.18 

Children 6-12:      0.031323     6.26    0.065217    13.04    0.118435    23.69 

Youth 13-19:        0.017332     3.47    0.029815     5.96    0.054124    10.82 

Adults 20-49:       0.019148     3.83    0.031090     6.22    0.066911    13.38 

Adults 50-99:       0.017495     3.50    0.027960     5.59    0.044332     8.87 

Female 13-49:       0.019721    28.17    0.031934    45.62    0.067067    95.81 


===============================================================================




Attachment 3:  Chronic Dietary Residue Input File for Fluazinam

DEEM FCID Version 3.16

Chronic NOAEL:  1.1 mg/kg bw/day
Chronic PAD:       0.011 mg/kg bw/day

Filename: C:\Documents and Settings\ddotson\My Documents\ DEEMFCID\Fluazinam \Fluazinam2012chronic.R08

Date created/last modified: 07-14-2012/13:13:47


-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2   
---------- ---- -------------------------------  ----------  ------ ------  -------
0101078000 1AB  Carrot                             0.700000   1.000  1.000  
0101078001 1AB  Carrot-babyfood                    0.700000   1.000  1.000  
0101079000 1AB  Carrot, juice                      0.700000   1.000  1.000  
0101168000 1AB  Ginseng, dried                     4.500000   1.000  1.000  
0103296000 1C   Potato, chips                      0.020000   1.000  1.000  
0103297000 1C   Potato, dry (granules/ flakes)     0.020000   6.500  1.000  
0103297001 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500  1.000  
0103298000 1C   Potato, flour                      0.020000   6.500  1.000  
0103298001 1C   Potato, flour-babyfood             0.020000   6.500  1.000  
0103299000 1C   Potato, tuber, w/peel              0.020000   1.000  1.000  
0103299001 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000  
0103300000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000  
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000  
0301165000 3A   Garlic, bulb                       0.200000   1.000  1.000  
0301165001 3A   Garlic, bulb-babyfood              0.200000   1.000  1.000  
0301237000 3A   Onion, bulb                        0.200000   1.000  1.000  
0301237001 3A   Onion, bulb-babyfood               0.200000   1.000  1.000  
0301238000 3A   Onion, bulb, dried                 0.200000   9.000  1.000  
0301238001 3A   Onion, bulb, dried-babyfood        0.200000   9.000  1.000  
0302338500 3B   Shallot, fresh leaves              0.200000   1.000  1.000  
0401204000 4A   Lettuce, head                      0.027000   1.000  1.000  
0401205000 4A   Lettuce, leaf                      2.700000   1.000  1.000  
0501061000 5A   Broccoli                           0.013500   1.000  1.000  
0501061001 5A   Broccoli-babyfood                  0.013500   1.000  1.000  
0501062000 5A   Broccoli, Chinese                  0.013500   1.000  1.000  
0501064000 5A   Brussels sprouts                   0.013500   1.000  1.000  
0501069000 5A   Cabbage                            0.013500   1.000  1.000  
0501071000 5A   Cabbage, Chinese, napa             0.013500   1.000  1.000  
0501072000 5A   Cabbage, Chinese, mustard          0.013500   1.000  1.000  
0501083000 5A   Cauliflower                        0.013500   1.000  1.000  
0501196000 5A   Kohlrabi                           0.013500   1.000  1.000  
0502063000 5B   Broccoli raab                      0.013500   1.000  1.000  
0502070000 5B   Cabbage, Chinese, bok choy         0.013500   1.000  1.000  
0502117000 5B   Collards                           0.013500   1.000  1.000  
0502194000 5B   Kale                               0.013500   1.000  1.000  
0502229000 5B   Mustard greens                     0.013500   1.000  1.000  
0502318000 5B   Rape greens                        0.013500   1.000  1.000  
0502389000 5B   Turnip, greens                     0.013500   1.000  1.000  
0600347000 6    Soybean, seed                      0.020000   1.000  1.000  
0600349000 6    Soybean, soy milk                  0.020000   1.000  1.000  
0600349001 6    Soybean, soy milk-babyfood or in   0.020000   1.000  1.000  
0600350000 6    Soybean, oil                       0.020000   1.000  1.000  
0600350001 6    Soybean, oil-babyfood              0.020000   1.000  1.000  
0601043000 6A   Bean, snap, succulent              0.135000   1.000  1.000  
0601043001 6A   Bean, snap, succulent-babyfood     0.135000   1.000  1.000  
0602031000 6B   Bean, broad, succulent             0.054000   1.000  1.000  
0602033000 6B   Bean, cowpea, succulent            0.054000   1.000  1.000  
0602037000 6B   Bean, lima, succulent              0.054000   1.000  1.000  
0603030000 6C   Bean, black, seed                  0.027000   1.000  1.000  
0603032000 6C   Bean, broad, seed                  0.027000   1.000  1.000  
0603034000 6C   Bean, cowpea, seed                 0.027000   1.000  1.000  
0603035000 6C   Bean,  great northern, seed        0.027000   1.000  1.000  
0603036000 6C   Bean, kidney, seed                 0.027000   1.000  1.000  
0603038000 6C   Bean, lima, seed                   0.027000   1.000  1.000  
0603039000 6C   Bean, mung, seed                   0.027000   1.000  1.000  
0603040000 6C   Bean, navy, seed                   0.027000   1.000  1.000  
0603041000 6C   Bean, pink, seed                   0.027000   1.000  1.000  
0603042000 6C   Bean, pinto, seed                  0.027000   1.000  1.000  
0603098000 6C   Chickpea, seed                     0.027000   1.000  1.000  
0603098001 6C   Chickpea, seed-babyfood            0.027000   1.000  1.000  
0603099000 6C   Chickpea, flour                    0.027000   1.000  1.000  
0603182000 6C   Guar, seed                         0.027000   1.000  1.000  
0603182001 6C   Guar, seed-babyfood                0.027000   1.000  1.000  
0802148000 8BC  Eggplant                           0.100000   1.000  1.000  
0802234000 8BC  Okra                               0.100000   1.000  1.000  
0802270000 8B   Pepper, bell                       0.100000   1.000  1.000  
0802270001 8B   Pepper, bell-babyfood              0.100000   1.000  1.000  
0802271000 8B   Pepper, bell, dried                0.100000   1.000  1.000  
0802271001 8B   Pepper, bell, dried-babyfood       0.100000   1.000  1.000  
0802272000 8BC  Pepper, nonbell                    0.100000   1.000  1.000  
0802272001 8BC  Pepper, nonbell-babyfood           0.100000   1.000  1.000  
0802273000 8BC  Pepper, nonbell, dried             0.100000   1.000  1.000  
0901075000 9A   Cantaloupe                         0.080000   1.000  1.000  
0901187000 9A   Honeydew melon                     0.080000   1.000  1.000  
0901399000 9A   Watermelon                         0.080000   1.000  1.000  
0901400000 9A   Watermelon, juice                  0.080000   1.000  1.000  
1100007000 11   Apple, fruit with peel             0.215000   1.000  1.000  
1100008000 11   Apple, peeled fruit                0.215000   1.000  1.000  
1100008001 11   Apple, peeled fruit-babyfood       0.215000   1.000  1.000  
1100009000 11   Apple, dried                       0.215000   8.000  1.000  
1100009001 11   Apple, dried-babyfood              0.215000   8.000  1.000  
1100010000 11   Apple, juice                       0.215000   1.300  1.000  
1100010001 11   Apple, juice-babyfood              0.215000   1.300  1.000  
1100011000 11   Apple, sauce                       0.215000   1.000  1.000  
1100011001 11   Apple, sauce-babyfood              0.215000   1.000  1.000  
1302057000 13B  Blueberry                          7.800000   1.000  1.000  
1302057001 13B  Blueberry-babyfood                 7.800000   1.000  1.000  
1302136000 13B  Currant                            7.800000   1.000  1.000  
1302137000 13B  Currant, dried                     7.800000   1.000  1.000  
1302149000 13B  Elderberry                         7.800000   1.000  1.000  
1302174000 13B  Gooseberry                         7.800000   1.000  1.000  
1302191000 13B  Huckleberry                        7.800000   1.000  1.000  
1304179000 13D  Grape, wine and sherry             3.000000   1.000  1.000  
3100046000 31   Beef, meat byproducts              0.050000   1.000  1.000  
3100046001 31   Beef, meat byproducts-babyfood     0.050000   1.000  1.000  
3100047000 31   Beef, fat                          0.050000   1.000  1.000  
3100047001 31   Beef, fat-babyfood                 0.050000   1.000  1.000  
3100048000 31   Beef, kidney                       0.050000   1.000  1.000  
3100049000 31   Beef, liver                        0.050000   1.000  1.000  
3100049001 31   Beef, liver-babyfood               0.050000   1.000  1.000  
3200170000 32   Goat, meat byproducts              0.050000   1.000  1.000  
3200171000 32   Goat, fat                          0.050000   1.000  1.000  
3200172000 32   Goat, kidney                       0.050000   1.000  1.000  
3200173000 32   Goat, liver                        0.050000   1.000  1.000  
3500340000 35   Sheep, meat byproducts             0.050000   1.000  1.000  
3500341000 35   Sheep, fat                         0.050000   1.000  1.000  
3500341001 35   Sheep, fat-babyfood                0.050000   1.000  1.000  
3500342000 35   Sheep, kidney                      0.050000   1.000  1.000  
3500343000 35   Sheep, liver                       0.050000   1.000  1.000  
8601000000 86A  Water, direct, all sources         0.037800   1.000  1.000  
8602000000 86B  Water, indirect, all sources       0.037800   1.000  1.000  
9500263000 O    Peanut                             0.020000   1.000  1.000  
9500264000 O    Peanut, butter                     0.020000   1.890  1.000  
9500265000 O    Peanut, oil                        0.020000   1.000  1.000  

Attachment 4:  Results of Chronic Dietary Exposure Assessment

Residue file name: C:\Documents and Settings\ddotson\My Documents\Deemfcid\
                Fluazinam2011\Fluazinam2011chronic.R98

Residue file dated: 07-14-2012/13:13:47
Analysis Date:  07-14-2012/13:16:45



Residue file name: C:\Documents and Settings\ddotson\My Documents\DEEM FCID\Fluazinam \Fluazinam2012chronic.R08
                                                 

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

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             cPAD       
--------------------------------------   -------------       ----------------
Total US Population                         0.002145                19.5%
Hispanic                                    0.001795                16.3%
Non-Hisp-White                              0.002318                21.1%
Non-Hisp-Black                              0.001494                13.6%
Non-Hisp-Other                              0.002299                20.9%
Nursing Infants                             0.002550                23.2%
Non-Nursing Infants                         0.005990                54.5%
Female 13+ PREG                             0.001372                12.5%
Children 1-6                                0.004298                39.1%
Children 7-12                               0.001856                16.9%
Male 13-19                                  0.001150                10.5%
Female 13-19/NP                             0.001192                10.8%
Male 20+                                    0.001756                16.0%
Female 20+/NP                               0.002268                20.6%
Seniors 55+                                 0.002145                19.5%
All Infants                                 0.004928                44.8%
Female 13-50                                0.002002                18.2%
Children 1-2                                0.005635                51.2%
Children 3-5                                0.003751                34.1%
Children 6-12                               0.002031                18.5%
Youth 13-19                                 0.001171                10.6%
Adults 20-49                                0.001936                17.6%
Adults 50-99                                0.002118                19.3%
Female 13-49                                0.001996                18.1%

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

