  SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	1 August 2007

SUBJECT:	Fluazinam Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessments for the Section 3
Registration Action on Ginseng, Brassica Vegetables, Legume Vegetables,
and Bushberries.

PC Code:	129098			Decision Number:  372193

DP Number:	340854

REVIEWER:	Michael A. Doherty, Ph.D., Chemist

Registration Action Branch 2

Health Effects Division (7509P)

THROUGH:	Christina Swartz, Branch Chief

William Cutchin, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

Richard A. Loranger, Ph.D., Branch Senior Scientist

Registration Action Branch 2

Health Effects Division (7509P)

TO:		Karlyn J. Bailey, Toxicologist

Registration Action Branch 2

Health Effects Division (7509P)

and

Shaja Brothers/Dan Rosenblatt, Team 05

Risk Integration, Minor Use, and Emergency Response 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 2.03 which use food consumption
data from the U.S. Department of Agriculture’s Continuing Surveys of
Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The
analyses were conducted as part of a human health aggregate risk
assessment for the requested uses of fluazinam on ginseng, Brassica
vegetables, legume vegetables, and bushberries.  An assessment of cancer
risk is not necessary for this chemical.

Both the acute and chronic analyses are based on tolerance-level
residues, assume 100% crop treated, and incorporate modeled estimated
drinking water concentrations (EDWCs).  Therefore, the resulting
exposure and risk estimates should be considered high-end and very
conservative.  Actual exposures and risks from fluazinam will likely be
lower than the values presented in these analyses.

The acute risk estimates are below HED’s level of concern for all
population subgroups, including those 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 U.S.
population, as a whole, is 1% of the acute PAD (aPAD).  For females
13-49 years of age, the risk estimate is 8% of their aPAD.  Risk
estimates for all other population subgroups are less than 8% aPAD. 
Likewise, chronic risk estimates are below HED’s level of concern for
all population subgroups.  The risk estimate for the U.S. population is
9% of the chronic PAD (cPAD).  The highest risk estimate is for the
“all infant” population subgroup at 16% cPAD.

These analyses indicate that there are no dietary exposure
considerations that preclude establishing tolerances for fluazinam.

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.  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:      HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf" 
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
W. Cutchin (22 Aug 2001, D276982).

II.	Residue Information

Fluazinam is currently registered in the U.S. for use on potato and
peanut, each with a tolerance of 0.02 ppm [40 CFR 180.574].  In
addition, there is a tolerance of 3.0 ppm for residues in/on wine grapes
(no U.S. registration).  The residues of concern for risk assessment are
fluazinam and its metabolite AMGT, combined.  Field trial data
reflecting AMGT residues were not provided for brassica vegetables and
legume vegetables; therefore, an upper-bound ratio of 0.35:1
(AMGT:fluazinam) was used to estimate the AMGT residue in these crops. 
AMGT is not formed in root and tuber crops and this factor was not used
for residues in/on potato and ginseng.  For bushberries, the mean ratio
of the metabolite:parent residues (0.11:1) from field trials was used to
estimate total residues of concern.   The residues used in the
assessments are based on tolerance-level residues of fluazinam (Table 1)
and should be considered high-end estimates.  The residue estimates
shown in Table 1 were used for both acute and chronic analyses.  The
assessment assumed 100% crop treated and used DEEM 7.76 default
processing factors for processed commodities (e.g., dried potato).  A
full listing of the residue inputs used in the analyses is included as
Attachments 1 and 2.

Table 1.  Summary of New-Use Food Crop Residue Levels Used in the Acute
and Chronic Dietary Exposure Analyses.

Crop/Crop Group	Recommended Tolerance Level, ppm	Residue Level for
Dietary Exposure Assessment, ppma

Ginseng	4.5	4.5b

Brassica Vegetables (Group 5)	0.01	0.0135

Edible Podded Legumes (except peas; Group 6A)	0.1	0.135

Succulent Shelled Pea and Bean (Group 6B)	0.04	0.054

Dried Shelled Pea and Bean (Group 6C)	0.02	0.027

Bushberries (Group 13B)	7.0	7.8c

a Residue level = recommended tolerance × 1.35 (from grape metabolism
data)

b AMGT is not a significant residue in root and tuber crops and no
correction is necessary for risk assessment

c Residue level = recommended tolerance × 1.11 (from field trial data)



 Drinking Water Data

The drinking water residue used in the dietary risk assessment was
provided by the Environmental Fate and Effects Division (EFED; J.
Meléndez, D334948, 7 Feb 2007) and incorporated directly into this
dietary assessment into the food categories “water, direct, all
sources” and “water, indirect, all sources.”  The estimated
drinking water concentration (EDWC) of 0.071 ppm is the estimated peak
concentration from the FIRST model (for more information, see  
HYPERLINK "http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ ) and was used for the acute
assessment.  The chronic assessment uses the EDWC based on total
residues of fluazinam in surface water (Table 2).

Table 2.  Maximum Tier I Estimated Drinking Water Concentrations (EDWCs)
for drinking water assessment based on ground application of fluazinam.

Drinking Water Source (Model Used) 	USE (Rate Modeled)	Maximum Estimated
Drinking Water Concentration  (EDWC; ppb) 

Groundwater

(SCI-GROW) Fluazinam and Total Residues of Fluazinam	Bushberries (3.90
lb a.i./A)	Acute and Chronic	0.187

Surface Water

(FIRST) Fluazinam	Bushberries (3.90 lb a.i./A)	Acute	71.0

	Bushberries (3.90 lb a.i./A)	Chronic	0.7

Surface Water

(FIRST) Total Residues of Fluazinam	Bushberries (3.90 lb a.i./A)	Acute
71.0

	Bushberries (3.90 lb a.i./A)	Chronic	17.7



IV.	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 2.03 which incorporates
consumption data from USDA’s Continuing Surveys of Food Intakes by
Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 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, but for acute exposure assessment are retained as
individual consumption events.  Based on analysis of the 1994-96, 98
CSFII consumption data, which took into account dietary patterns and
survey respondents, HED concluded that it is most appropriate to report
risk for the following population subgroups: the general U.S.
population, all infants (<1 year old), children 1-2, children 3-5,
children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+
years old.

For chronic dietary exposure assessment, an estimate of the residue
level in 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 all tiers of analysis.  However, for tiers 1 and 2, any
significant differences in user vs. per capita exposure and risk are
specifically identified and noted in the risk assessment.

V.	Toxicological Information

Adequate toxicological data have been submitted to permit assessment of
fluazinam.  The data show that the primary target organ for fluazinam is
the liver and that acute and chronic dietary assessments are
appropriate.  The data also support reducing the FQPA factor to 1X. 
Based on the available information, a dietary assessment of cancer risk
is not necessary.  Detailed toxicological considerations can be found in
the human health risk assessment for fluazinam (K. Bailey et al.,
D334949).  The fluazinam doses and endpoints for dietary exposure
assessments are summarized in Table 3.

Table 3.  Toxicological Doses and Endpoints for Fluazinam for Use in
Dietary 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

Total UF=100x	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

Total UF=100x	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 possible increased incidence of fetal
skeletal abnormalities.

Chronic Dietary (All Populations)	NOAEL= 1.1 mg/kg/day

	UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x	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”

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 (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. N/A = not
applicable.

  TC \l3 "3.5.10	Classification of Carcinogenic Potential 

VI.	Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned
when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ 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.  Risk estimates for all population subgroups, for
both the acute and the chronic analyses, are below HED’s level of
concern.  Full listings of exposure and risk estimates are included in
Attachments 3 (acute analysis) and 4 (chronic analysis).

Table 4.  Summary of Acute and Chronic Exposure and Risk Estimates for
Fluazinam.

Population Subgroup	Acute Assessment (95th Percentile)	Chronic
Assessment

	PAD, mg/day	Exposure Estimate, mg/day	% Pad	PAD, mg/day	Exposure
Estimate, mg/day	% Pad

U.S. Population	0.5	0.006015	1	0.011	0.000953	9

All infants	0.5	0.015211	3	0.011	0.001799	16

Children 1-2 yrs	0.5	0.007019	1	0.011	0.001133	10

Children 3-5 yrs	0.5	0.006323	1	0.011	0.000996	9

Children 6-12 yrs	0.5	0.004439	1	0.011	0.000650	6

Youth 13-19 yrs	0.5	0.003344	1	0.011	0.000438	4

Adults 20-49 yrs	0.5	0.005903	1	0.011	0.000996	9

Adults 50+ yrs	0.5	0.006933	1	0.011	0.001123	10

Females 13-49 yrs	0.07	0.005809	8	0.011	0.001016	9

Assessments with the highest risk estimates are bolded

VII.	Characterization of Inputs/Outputs

Both the acute and chronic assessments are based on tolerance-level
residues, with worst-case assumptions regarding levels of the metabolite
AMGT.  In addition, it was assumed that all crops with registered or
requested uses of fluazinam were treated (i.e., 100% crop treated). 
These assumptions result in highly conservative, health-protective
estimates of exposure and risk.

VIII.	Conclusions

The exposure estimates derived by the dietary exposure model are likely
to be overestimates of actual exposures that may occur.  Even so, the
aggregate (food + water) dietary risk estimates are below HED’s level
of concern for all population subgroups for both the acute and chronic
exposure scenarios.  There are no dietary exposure considerations that
preclude registering the proposed uses and establishing tolerances at
the levels recommended by HED.

IX.		List of Attachments

Attachment 1.  Residue inputs for the acute dietary exposure assessments
of fluazinam.

Attachment 2.  Residue inputs for the chronic dietary exposure
assessments of fluazinam.

Attachment 3.  Summary of acute dietary exposure and risk analysis for
fluazinam.

Attachment 4.  Summary of chronic dietary exposure and risk analysis for
fluazinam.

cc:	M. Doherty (HED/RAB2), W. Drew (HED/RAB2)

Attachment 1.  Residue inputs the acute dietary exposure assessments of
fluazinam.

U.S. Environmental Protection Agency                                
Ver. 2.02

DEEM-FCID Acute analysis for FLUAZINAM

Residue file name: C:\Documents and Settings\mdoherty\My
Documents\Chemistry Reviews\DEEM Runs\Fluazinam\129098a.R98

Analysis Date 07-17-2007             Residue file dated:
07-17-2007/10:27:53/8

Reference dose (aRfD) = 0.5 mg/kg bw/day

Comment: aPAD of 0.5 kg/day is for general pop.  Female 13-49 aPAD =
0.07 mg/day

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

06030300 6C   Bean, black, seed                  0.027000   1.000  1.000

06020310 6B   Bean, broad, succulent             0.054000   1.000  1.000

06030320 6C   Bean, broad, seed                  0.027000   1.000  1.000

06020330 6B   Bean, cowpea, succulent            0.054000   1.000  1.000

06030340 6C   Bean, cowpea, seed                 0.027000   1.000  1.000

06030350 6C   Bean,  great northern, seed        0.027000   1.000  1.000

06030360 6C   Bean, kidney, seed                 0.027000   1.000  1.000

06020370 6B   Bean, lima, succulent              0.054000   1.000  1.000

06030380 6C   Bean, lima, seed                   0.027000   1.000  1.000

06030390 6C   Bean, mung, seed                   0.027000   1.000  1.000

06030400 6C   Bean, navy, seed                   0.027000   1.000  1.000

06030410 6C   Bean, pink, seed                   0.027000   1.000  1.000

06030420 6C   Bean, pinto, seed                  0.027000   1.000  1.000

06010430 6A   Bean, snap, succulent              0.135000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.135000   1.000  1.000

13020570 13B  Blueberry                          7.800000   1.000  1.000

13020571 13B  Blueberry-babyfood                 7.800000   1.000  1.000

05010610 5A   Broccoli                           0.013500   1.000  1.000

05010611 5A   Broccoli-babyfood                  0.013500   1.000  1.000

05010620 5A   Broccoli, Chinese                  0.013500   1.000  1.000

05020630 5B   Broccoli raab                      0.013500   1.000  1.000

05010640 5A   Brussels sprouts                   0.013500   1.000  1.000

05010690 5A   Cabbage                            0.013500   1.000  1.000

05020700 5B   Cabbage, Chinese, bok choy         0.013500   1.000  1.000

05010710 5A   Cabbage, Chinese, napa             0.013500   1.000  1.000

05010720 5A   Cabbage, Chinese, mustard          0.013500   1.000  1.000

05010830 5A   Cauliflower                        0.013500   1.000  1.000

06030980 6C   Chickpea, seed                     0.027000   1.000  1.000

06030981 6C   Chickpea, seed-babyfood            0.027000   1.000  1.000

06030990 6C   Chickpea, flour                    0.027000   1.000  1.000

05021170 5B   Collards                           0.013500   1.000  1.000

13021360 13B  Currant                            7.800000   1.000  1.000

13021370 13B  Currant, dried                     7.800000   1.000  1.000

13021490 13B  Elderberry                         7.800000   1.000  1.000

01011680 1AB  Ginseng, dried                     4.500000   1.000  1.000

13021740 13B  Gooseberry                         7.800000   1.000  1.000

95001790 O    Grape, wine and sherry             3.000000   1.000  1.000

06031820 6C   Guar, seed                         0.027000   1.000  1.000

06031821 6C   Guar, seed-babyfood                0.027000   1.000  1.000

13021910 13B  Huckleberry                        7.800000   1.000  1.000

05021940 5B   Kale                               0.013500   1.000  1.000

05011960 5A   Kohlrabi                           0.013500   1.000  1.000

06032030 6C   Lentil, seed                       0.027000   1.000  1.000

05022290 5B   Mustard greens                     0.013500   1.000  1.000

06022550 6B   Pea, succulent                     0.054000   1.000  1.000

06022551 6B   Pea, succulent-babyfood            0.054000   1.000  1.000

06032560 6C   Pea, dry                           0.027000   1.000  1.000

06032561 6C   Pea, dry-babyfood                  0.027000   1.000  1.000

06012570 6A   Pea, edible podded, succulent      0.135000   1.000  1.000

06032580 6C   Pea, pigeon, seed                  0.027000   1.000  1.000

06022590 6B   Pea, pigeon, succulent             0.054000   1.000  1.000

95002630 O    Peanut                             0.020000   1.000  1.000

95002640 O    Peanut, butter                     0.020000   1.890  1.000

95002650 O    Peanut, oil                        0.020000   1.000  1.000

01032960 1C   Potato, chips                      0.020000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500  1.000

01032980 1C   Potato, flour                      0.020000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.020000   1.000  1.000

01032990 1C   Potato, tuber, w/peel              0.020000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000

05023180 5B   Rape greens                        0.013500   1.000  1.000

05023890 5B   Turnip, greens                     0.013500   1.000  1.000

86010000 O    Water, direct, all sources         0.071000   1.000  1.000

86020000 O    Water, indirect, all sources       0.071000   1.000  1.000

Attachment 2.  Residue inputs for the chronic dietary exposure
assessments of fluazinam.

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FLUAZINAM                         
1994-98 data

Residue file: C:\Documents and Settings\mdoherty\My Documents\Chemistry
Reviews\DEEM Runs\Fluazinam\129098c.R98

                                                           Adjust. #2
NOT used

Analysis Date 07-17-2007             Residue file dated:
07-17-2007/10:28:39/8

Reference dose (RfD) = 0.011 mg/kg bw/day

Comment:aPAD of 0.5 kg/day is for general pop.  Female 13-49 aPAD = 0.07
mg/day

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

06030300 6C   Bean, black, seed                  0.027000   1.000     
1.000   

06020310 6B   Bean, broad, succulent             0.054000   1.000     
1.000   

06030320 6C   Bean, broad, seed                  0.027000   1.000     
1.000   

06020330 6B   Bean, cowpea, succulent            0.054000   1.000     
1.000   

06030340 6C   Bean, cowpea, seed                 0.027000   1.000     
1.000   

06030350 6C   Bean,  great northern, seed        0.027000   1.000     
1.000   

06030360 6C   Bean, kidney, seed                 0.027000   1.000     
1.000   

06020370 6B   Bean, lima, succulent              0.054000   1.000     
1.000   

06030380 6C   Bean, lima, seed                   0.027000   1.000     
1.000   

06030390 6C   Bean, mung, seed                   0.027000   1.000     
1.000   

06030400 6C   Bean, navy, seed                   0.027000   1.000     
1.000   

06030410 6C   Bean, pink, seed                   0.027000   1.000     
1.000   

06030420 6C   Bean, pinto, seed                  0.027000   1.000     
1.000   

06010430 6A   Bean, snap, succulent              0.135000   1.000     
1.000   

06010431 6A   Bean, snap, succulent-babyfood     0.135000   1.000     
1.000   

13020570 13B  Blueberry                          7.800000   1.000     
1.000   

13020571 13B  Blueberry-babyfood                 7.800000   1.000     
1.000   

05010610 5A   Broccoli                           0.013500   1.000     
1.000   

05010611 5A   Broccoli-babyfood                  0.013500   1.000     
1.000   

05010620 5A   Broccoli, Chinese                  0.013500   1.000     
1.000   

05020630 5B   Broccoli raab                      0.013500   1.000     
1.000   

05010640 5A   Brussels sprouts                   0.013500   1.000     
1.000   

05010690 5A   Cabbage                            0.013500   1.000     
1.000   

05020700 5B   Cabbage, Chinese, bok choy         0.013500   1.000     
1.000   

05010710 5A   Cabbage, Chinese, napa             0.013500   1.000     
1.000   

05010720 5A   Cabbage, Chinese, mustard          0.013500   1.000     
1.000   

05010830 5A   Cauliflower                        0.013500   1.000     
1.000   

06030980 6C   Chickpea, seed                     0.027000   1.000     
1.000   

06030981 6C   Chickpea, seed-babyfood            0.027000   1.000     
1.000   

06030990 6C   Chickpea, flour                    0.027000   1.000     
1.000   

05021170 5B   Collards                           0.013500   1.000     
1.000   

13021360 13B  Currant                            7.800000   1.000     
1.000   

13021370 13B  Currant, dried                     7.800000   1.000     
1.000   

13021490 13B  Elderberry                         7.800000   1.000     
1.000   

01011680 1AB  Ginseng, dried                     4.500000   1.000     
1.000   

13021740 13B  Gooseberry                         7.800000   1.000     
1.000   

95001790 O    Grape, wine and sherry             3.000000   1.000     
1.000   

06031820 6C   Guar, seed                         0.027000   1.000     
1.000   

06031821 6C   Guar, seed-babyfood                0.027000   1.000     
1.000   

13021910 13B  Huckleberry                        7.800000   1.000     
1.000   

05021940 5B   Kale                               0.013500   1.000     
1.000   

05011960 5A   Kohlrabi                           0.013500   1.000     
1.000   

06032030 6C   Lentil, seed                       0.027000   1.000     
1.000   

05022290 5B   Mustard greens                     0.013500   1.000     
1.000   

06022550 6B   Pea, succulent                     0.054000   1.000     
1.000   

06022551 6B   Pea, succulent-babyfood            0.054000   1.000     
1.000   

06032560 6C   Pea, dry                           0.027000   1.000     
1.000   

06032561 6C   Pea, dry-babyfood                  0.027000   1.000     
1.000   

06012570 6A   Pea, edible podded, succulent      0.135000   1.000     
1.000   

06032580 6C   Pea, pigeon, seed                  0.027000   1.000     
1.000   

06022590 6B   Pea, pigeon, succulent             0.054000   1.000     
1.000   

95002630 O    Peanut                             0.020000   1.000     
1.000   

95002640 O    Peanut, butter                     0.020000   1.890     
1.000   

95002650 O    Peanut, oil                        0.020000   1.000     
1.000   

01032960 1C   Potato, chips                      0.020000   1.000     
1.000   

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500     
1.000   

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500     
1.000   

01032980 1C   Potato, flour                      0.020000   1.000     
1.000   

01032981 1C   Potato, flour-babyfood             0.020000   1.000     
1.000   

01032990 1C   Potato, tuber, w/peel              0.020000   1.000     
1.000   

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000     
1.000   

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000     
1.000   

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000     
1.000   

05023180 5B   Rape greens                        0.013500   1.000     
1.000   

05023890 5B   Turnip, greens                     0.013500   1.000     
1.000   

86010000 O    Water, direct, all sources         0.017700   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.017700   1.000     
1.000   

Attachment 3.  Summary of acute dietary exposure and risk analysis for
fluazinam.

U.S. Environmental Protection Agency                                 
Ver. 2.02

DEEM-FCID ACUTE Analysis for FLUAZINAM                          
(1994-98 data)

Residue file: 129098a.R98                         Adjustment factor #2
NOT used.

Analysis Date: 07-17-2007/10:31:43    Residue file dated:
07-17-2007/10:27:53/8

Acute Pop Adjusted Dose (aPAD) varies with population; see individual
reports

Daily totals for food and foodform consumption used.

Run Comment: "aPAD of 0.5 kg/day is for general pop.  Female 13-49 aPAD
= 0.07

 mg/day"

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th
Percentile

                   Exposure   % aPAD    Exposure   % aPAD    Exposure  
% aPAD 

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

U.S. Population:

                    0.006015     1.20    0.016307     3.26    0.034661  
  6.93 

All infants:

                    0.015211     3.04    0.025064     5.01    0.054080  
 10.82 

Children 1-2 yrs:

                    0.007019     1.40    0.012500     2.50    0.043972  
  8.79 

Children 3-5 yrs:

                    0.006323     1.26    0.010539     2.11    0.043124  
  8.62 

Children 6-12 yrs:

                    0.004439     0.89    0.007210     1.44    0.020699  
  4.14 

Youth 13-19 yrs:

                    0.003344     0.67    0.006779     1.36    0.018525  
  3.70 

Adults 20-49 yrs:

                    0.005903     1.18    0.017222     3.44    0.034739  
  6.95 

Adults 50+ yrs:

                    0.006933     1.39    0.017895     3.58    0.037081  
  7.42 

Females 13-49 yrs:

                    0.005809     8.30    0.018964    27.09    0.035119  
 50.17 

Attachment 4.  Summary of chronic dietary exposure and risk analysis
for fluazinam.

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FLUAZINAM                        (1994-98
data)

Residue file name: C:\Documents and Settings\mdoherty\My
Documents\Chemistry Reviews\DEEM Runs\Fluazinam\129098c.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 07-17-2007/10:29:17     Residue file dated:
07-17-2007/10:28:39/8

Reference dose (RfD, Chronic) = .011 mg/kg bw/day

COMMENT 1: aPAD of 0.5 kg/day is for general pop.  Female 13-49 aPAD =
0.07 mg/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000953                
8.7%

U.S. Population (spring season)             0.000916                
8.3%

U.S. Population (summer season)             0.001044                
9.5%

U.S. Population (autumn season)             0.000942                
8.6%

U.S. Population (winter season)             0.000905                
8.2%

Northeast region                            0.001055                
9.6%

Midwest region                              0.000848                
7.7%

Southern region                             0.000806                
7.3%

Western region                              0.001206               
11.0%

Hispanics                                   0.000735                
6.7%

Non-hispanic whites                         0.001064                
9.7%

Non-hispanic blacks                         0.000546                
5.0%

Non-hisp/non-white/non-black                0.000809                
7.4%

All infants (< 1 year)                      0.001799               
16.4%

Nursing infants                             0.000957                
8.7%

Non-nursing infants                         0.002118               
19.3%

Children 1-6  yrs                           0.001014                
9.2%

Children 7-12 yrs                           0.000617                
5.6%

Females 13-19 (not preg or nursing)         0.000429                
3.9%

Females 20+ (not preg or nursing)           0.001178               
10.7%

Females 13-50 yrs                           0.000992                
9.0%

Females 13+ (preg/not nursing)              0.000526                
4.8%

Females 13+ (nursing)                       0.000633                
5.8%

Males 13-19 yrs                             0.000445                
4.0%

Males 20+ yrs                               0.000914                
8.3%

Seniors 55+                                 0.001145               
10.4%

Children 1-2 yrs                            0.001133               
10.3%

Children 3-5 yrs                            0.000996                
9.1%

Children 6-12 yrs                           0.000650                
5.9%

Youth 13-19 yrs                             0.000438                
4.0%

@

„@

„`ú^„@

1

7

:

a



€

œ

¼

½

Ã

ê

ü

:

Z

[

\

½

¾

Â

Ã

ê

 ê

jì

摧眄

摧眄

摧眄

摧眄

摧眄

摧眄

Ø	@

Ø	@

Ø	@

摧❬³

愀Ĥ摧品R

摧廷â

摧廷â

摧❬³

愀Ĥ摧品R

摧廷â

摧廷â

摧❬³

愀Ĥ摧品R

摧廷â

摧廷â

摧❬³

愀Ĥ摧品R

摧廷â

摧廷â

摧❬³

愀Ĥ摧品R

摧廷â

摧廷â

摧❬³

愀Ĥ摧品R

摧廷â

摧廷â

摧❬³

愀Ĥ摧品R

摧廷â

摧廷â

摧❬³

愀Ĥ摧品R

摧廷â

摧廷â

摧❬³

愀Ĥ摧品R

摧廷â

摧廷â

&

&

&

&

Adults 20-49 yrs                            0.000996                
9.1%

Adults 50+ yrs                              0.001123               
10.2%

Females 13-49 yrs                           0.001016                
9.2%

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

Fluazinam 	Dietary Exposure and Risk Assessment	DP Number:  340854

PC Code:  129098

 PAGE   

Page   PAGE  1  of   NUMPAGES  12 

DRAFT – Confidential, Internal, and Deliberative Material

[Chemical Name]	Dietary Exposure and Risk Assessment	DP Number:
[xxxxxxx]

PC Code:  [xxxxxx]		

