Document ID: EPA-HQ-OPP-2007-1192-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-03-04T05:00Z

UNITED STAES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

 PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:  		July 8, 2008

SUBJECT:	Famoxadone.  AMENDED Acute and Chronic Dietary (Food and Water)
Exposure Assessments for the Petition Proposing Tolerances for Residues
of Famoxadone on Bulb Vegetables, Crop Group 3; Leafy Greens, Subgroup
4A; Leaf Petioles, Subgroup 4B; and Cilantro.

PC Code:  	113202	DP Numbers:	354336 & 354337

Decision No.:	386103 & 386104	Registration No.:	352-604

Petition No.:	7E7280, 7E7281	Regulatory Action:	Section 3

Assessment Type:	Dietary	Registration Case No.:	‘None’

TXR No.:	‘None’	CAS No.:	131807-57-3

MRID No.:	‘None’	40 CFR:	§180.587

FROM:	Breann Hanson, Biologist 

Alternative Risk Integration and Assessment (ARIA) Team

Risk Integration Minor Use and Emergency Response Branch 			
(RIMUERB)/Registration Division (RD) (7505P)

THROUGH:   William Cutchin, Acting Senior Branch Scientist

		ARIA Team

RIMERB/RD (7505P)

AND

Thurston Morton, Chemist

Dennis McNeilly, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (HED) (7509P)

TO:		Breann Hanson, Biologist

ARIA Team

RIMUERB/RD (7505P)

	Susan Stanton / Daniel Rosenblatt

	RIMUERB/RD (7505P)

Executive Summary

The purpose of this memorandum is to amend the results of a dietary
(food + drinking water) exposure analysis for the fungicide famoxadone,
[3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione].  In
this analysis, the chronic dietary exposure and risk estimates resulting
from food and water intake were determined for the general U.S.
population and various population subgroups.  The end-use product (EP)
relevant for this registration action is Tanos® Fungicide (EPA Reg. No.
352-604), a dry flowable (DF) formulation containing 25% ai cymoxanil
plus 25% ai famoxadone.  This summary document addresses only the
dietary risk data for famoxadone; the dietary risk data for cymoxanil
will be addressed in a separate summary document.

A chronic dietary risk assessment was conducted using the Dietary
Exposure Evaluation Model (DEEM-FCID™, Version 2.03) which uses food
consumption data from the U.S. Department of Agriculture’s Continuing
Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. 
This analysis was performed to support two separate Interregional
Research Project No. 4 (IR-4) petition requests to establish tolerances
for residues of famoxadone in/on leaf petioles, subgroup 4B (PP#7E7280)
and on leafy greens, subgroup 4A; bulb vegetables, group 3 and on
cilantro, leaves (PP#7E7281).  Although IR-4 has indicated that they
will request a tolerance for caneberry, subgroup 13A, a tolerance of
10.0 ppm is already established for this crop group.  IR-4 is
concurrently requesting the removal of the established famoxadone
tolerance for lettuce, head at 10.0 ppm.

In calculating dietary risk estimates, ARIA has compared the chronic
population-adjusted dose (cPAD) to the respective estimated dietary
exposures.  Typically, ARIA has concerns regarding dietary risk when the
estimates exceed 100% of the cPAD.  With the conservative assumptions
noted below, risk estimates associated with dietary exposure to
famoxadone are significantly below ARIA’s level of concern.

 Acute Dietary (Food + Drinking Water) Exposure Results and
Characterization

HED has agreed upon the doses and endpoints for use in human health risk
assessments for famoxadone.  There was no appropriate endpoint for
assessing acute dietary exposure; therefore, no acute dietary risk
assessment was performed.

Chronic Dietary (Food + Drinking Water) Exposure Results and
Characterization

 μg/L (ppb) was used in this analysis.  The results of the analysis
indicate that chronic risk from the dietary (food + drinking water)
exposure to famoxadone will not exceed ARIA’s level of concern for the
general U.S. population, and all population subgroups.  The chronic
dietary risk estimate for the highest reported exposed population
subgroup, adults 20-49 years old, is 59% of the cPAD.  The general US
population utilizes 47% of the cPAD.

Cancer Exposure Results and Characterization

HED classified famoxadone as a “not likely carcinogen;” therefore,
quantification of human cancer risk is not required.

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 ARIA 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, ARIA is concerned when
estimated dietary risk exceeds 100% of the PAD.  ARIA is generally
concerned when estimated cancer risk exceeds one in one million (i.e.,
the risk exceeds 1 x 10-6).  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,” 6/21/2000, 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 (8/20/99).

The most recent dietary risk assessment for famoxadone was conducted by
B. Hanson (DP#: 349186, 5/27/2008).

II.	Residue Information

Tolerances:  Tolerances for residues of famoxadone are listed in 40 CFR
§180.587 and are expressed in terms of famoxadone per se.  Famoxadone
tolerances for plant commodities have been established for: caneberry,
subgroup 13A at 10 ppm; grape raisin at 4.0 ppm; hop, dried cone at 80
ppm; lettuce, head at 10.0 ppm; potato at 0.02 ppm; tomato at 1.0 ppm;
vegetable, cucurbits, group 9 at 0.30 ppm; vegetable, fruiting, group 8
except tomato at 4.0 ppm; and grape as a tolerance with a regional
registration at 2.5 ppm.  Famoxadone tolerances for animal commodities
have been established for milk fat at 0.06 ppm and the fat at 0.02 ppm
and liver at 0.05 ppm of cattle, goat, horse, and sheep.

Residue of Concern:  HED believes that a metabolism study with an
oilseed or grain crop is needed to complete a general understanding of
the nature of the residue in all crops.  However, for the purposes of
this IR-4 request, the residue of concern for tolerance expression and
risk assessment purposes is considered to be the parent compound per se.

Residue Data Used for Chronic Assessment:  

For the previous assessment, the dietary exposure analyses used average
field trial values for crops and anticipated residues for ruminant fat,
liver, and milk fat.  Empirical processing factors were used to refine
the residue estimates of processed tomato, pepper, potato, and grape
commodities.  Average field trial values and processing factors are
taken from the famoxadone residue chemistry summary document (DP#:
287253, M. Doherty, 4/16/2003).  Anticipated residues were also
calculated from the mean levels for grapes, hops and caneberries,
subgroup 13A (DP#: 323682 & 333260, W. Cutchin, 11/29/2006).  

For the current assessment, anticipated residues were derived from the
current residue chemistry memoranda (DP# 349184 & 349198; W. Cutchin;
4/14/2008) from the mean levels for leafy greens (subgroup 4A), leafy
petioles (subgroup 4B), cilantro, spinach, and dry bulb/green onions. 

Leafy vegetables are both washed and have outer wrapper leaves removed
before eaten; therefore reduction factors can be determined for such
instances.  A reduction factor for wrapper to no-wrapper (0.22x) was
determined from DER 44946430 for leaf lettuce, which was summarized in
an HED memorandum (DP#: 271377 & 287253, M. Doherty, 4/18/2003).  A
reduction factor was also determined for unwashed to washed leaf lettuce
(0.59x) from the current residue chemistry memoranda.

Residue levels and processing factors used in the dietary exposure
analyses are shown in Table 1.  

Table 1.  Residue Levels Used in Chronic Dietary Assessment for
Famoxadone.

RAC	Food Form	Residue Level, ppm	Processing Factor	Comments

Grape	RAC	0.44	Not Applicable	Grape AR

Grape	Juice	0.44	0.01	Grape AR

Grape	Raisin	0.44	1.9	Grape AR

Grape	Wine and Sherry	0.44	0.01	Grape AR

Potato	Chips	0.01	1	Potato AR

Potato	Dry (granules/flakes)	0.01	1	Potato AR

Potato	Flour	0.01	1	Potato AR

Potato	Tuber, w/ peel	0.01	Not Applicable	Potato AR

Potato	Tuber, w/o peel	0.01	1	Potato AR

Lettuce, Head	RAC	0.28	Not Applicable	Lettuce AR (w/o wrapper) x washing
reduction

Eggplant	RAC	0.35	Not Applicable	Bell Pepper AR

Okra	RAC	1.31	Not Applicable	Non-bell Pepper AR

Pepper	Bell	0.35	Not Applicable	Bell Pepper AR

Pepper	Bell, Dried	0.35	1.65 (tomato)	Bell Pepper AR

Pepper	Nonbell	1.31	Not Applicable	Non-bell Pepper AR

Pepper	Nonbell, Dried	1.31	1.65 (tomato)	Non-bell Pepper AR

Tomatillo	RAC	0.28	Not Applicable	Tomato AR

Tomato	RAC	0.28	Not Applicable	Tomato AR

Tomato	Paste	0.28	1.3	Tomato AR

Tomato	Puree	0.28	0.4	Tomato AR

Tomato	Dried	0.28	1.65	Tomato AR

Tomato	Juice	0.28	0.3	Tomato AR

Balsam pear	RAC	0.05	Not Applicable	Cucumber AR

Caneberries, subgroup 13A	RAC	2.01	Not Applicable	Caneberry AR

Cantaloupe	RAC	0.13	Not Applicable	Cantaloupe AR

Casaba	RAC	0.13	Not Applicable	Cantaloupe AR

Chayote	RAC	0.11	Not Applicable	Summer Squash AR

Chinese waxgourd	RAC	0.05	Not Applicable	Cucumber AR

Cilantro	RAC	0.28	Not Applicable	Lettuce AR (w/o wrapper) x washing
reduction

Cucumber	RAC	0.05	Not Applicable	Cucumber AR

Honeydew melon	RAC	0.13	Not Applicable	Cantaloupe AR

Hops	RAC	34.16	Not Applicable	Hop AR

Leafy Greens, subgroup 4A	RAC	1.11	Not Applicable	Leaf Lettuce, washed
AR x wrapper reduction 

Leaf Petioles, subgroup 4B	RAC	4.43	Not Applicable	Washed Celery AR

Onion, dry bulb	RAC	0.07	Not Applicable	Onion, dry bulb AR

Onion, green	RAC	6.11	Not Applicable	Green Onion AR

Pumpkin	RAC	0.11	Not Applicable	Summer Squash AR

Pumpkin	Seed	0.11	Not Applicable	Summer Squash AR

Squash, summer	RAC	0.11	Not Applicable	Summer Squash AR

Squash, winter	RAC	0.11	Not Applicable	Summer Squash AR

Watermelon	RAC	0.13	Not Applicable	Cantaloupe AR

Watermelon	Juice	0.13	1	Cantaloupe AR

Soybean	seeds	0.02	1	Recommended tolerance level  - 05MN13

Soybean	flour	0.02	1	Recommended tolerance level  - 05MN13

Soybean	flour-babyfood	0.02	1	Recommended tolerance level  - 05MN13

Soybean	soy milk	0.02	1	Recommended tolerance level  - 05MN13

Soybean	soy milk-babyfood	0.02	1	Recommended tolerance level  - 05MN13

Soybean	oil	0.02	

1	Recommended tolerance level  - 05MN13

Soybean	oil-babyfood	0.02	1	Recommended tolerance level  - 05MN13

Spinach	RAC	4.33	Not Applicable	Spinach, washed AR x wrapper reduction 

Fat of cattle, goats, and sheep	RAC	0.0075	Not Applicable	AR from a
dietary burden of 0.0405 ppm

Liver of cattle, goats, and sheep	RAC	0.00285	Not Applicable

	AR from a dietary burden of 0.0405 ppm

Milk, fat	RAC	0.00506	Not Applicable	AR from a dietary burden of 0.0305
ppm

The previous dietary exposure analyses used a Screening-Level Usage
Analysis (SLUA), provided by BEAD, for %CT information of current uses
of famoxadone (J. Alsadek, 8/31/2006).

For this current petition, BEAD provided projected percent crop treated
(PPCT) estimates (DP#: 349850 & 349852, A. Halvorson, 4/7/2008) for
celery, lettuce, spinach and grapes.   Famoxadone is to be registered
for use on grapes grown east of the Rockies only.

PPCT information is listed in Table 2, below.

Table 2.  Percent Crop Treated Information Used in Chronic Dietary
Exposure Analysis                       

Commodity	Percent of Crop Treated

Celery	39

Cucumbers	5

Grapes, wine	5

Grapes, table	5

Grape, juice	50

Lettuce, head	67

Lettuce, other	62

Peppers	5

Potatoes	5

Pumpkins	5

Spinach	39

Squash	<1*

Tomatoes	10

Watermelons	<1*

* Value rounded to 1.

As part of the current petition, the proposed uses and the submitted
data support the following tolerances for residues of famoxadone per se
in/on the following crop subgroups (DP# 349184 & 349198; W. Cutchin;
4/14/2008):

Onion, bulb, subgroup 3-07A	0.45 ppm

Onion, green, subgroup 3-07B	40.0 ppm

Leafy greens, subgroup 4A	50.0 ppm

Leaf, petioles, subgroup 4B	25.0 ppm

Cilantro, leaves	50.0 ppm

III.	Drinking Water Data

The drinking water residues used in the dietary risk assessment were
provided by the Environmental Fate and Effects Division (EFED) in a
memoranda “Tier II Drinking Water Exposure Assessment for Famoxadone
Use on Leafy Greens subgroup 4A, Bulb Vegetabels Group 3, Cilantro and
Caneberry subgroup 13A and Leaf Petioles subgroup 4B” (DP#s: 347671 &
347674, J. Lin, 4/30/2008) and incorporated directly into this dietary
assessment.  Water residues were incorporated in the DEEM-FCID into the
food categories “water, direct, all sources” and “water, indirect,
all sources.” 

μg/L (ppb) in surface water and 0.010 μg/L (ppb) in ground water. 
These values generally represent upper-bound estimates of the
concentrations that might be found in surface water and groundwater
resulting from the use of famoxadone.  The assessment was based on the
proposed leafy greens (subgroup 4A) and leafy petioles (subgroup 4B)
use.  The PRZM/EXAMS Model was used to estimate surface water
concentrations and the SCIGROW Model was used to estimate groundwater
concentrations.

IV.	DEEM-FCID™ Program and Consumption Information

The famoxadone chronic dietary exposure assessment was 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

HED has previously agreed upon the doses and endpoints for use in human
health risk assessments for famoxadone.  As there were no toxic effects
attributable to a single dose, an endpoint of concern was not identified
to quantitate acute-dietary risk to the general population or to the
subpopulation females 13-49 years old.  There was no appropriate
endpoint for assessing acute dietary exposure.  For chronic dietary
exposure, the toxicology endpoint was selected from a subchronic feeding
study in dogs in which the LOAEL was 1.4 mg/kg/day based on microscopic
lens lesions (cataracts) in the eyes of female dogs.  An additional
Uncertainty Factor (UF) of 10 was added to the conventional UF of 100
for the use of a LOAEL and the use of a subchronic study.  The cRfD is
0.0014 mg/kg/day.  The doses relevant to dietary exposure are summarized
in Table 3, below.  

The Cancer Assessment Review Committee (CARC) classified famoxadone as
“not likely to be carcinogenic to humans.” As such, a cancer dietary
risk assessment is not warranted.

Table 3.  Summary of Toxicological Doses and Endpoints for Famoxadone
Relevant to Human Health Dietary Risk Assessment.

Exposure

Scenario	

Dose Used in Risk Assessment, UF 	

Special FQPA SF and LOC for Risk Assessment	

Study and Toxicological Effects

Acute Dietary

(All populations)	

NOAEL = none 

UF = none

Acute RfD = none	

NA	

No appropriate endpoint attributable to a single oral dose was
identified in the available toxicology studies on Famoxadone.  

Chronic Dietary

(All populations)	

LOAEL= 1.4 mg/kg/day

UF = 1000

Chronic RfD = 0.0014 mg/kg/day	

FQPA SF = 1

Chronic PAD = 

Chronic RfD

 FQPA SF

Chronic PAD = 0.0014

 mg/kg/day	

13-Week Feeding Study in Dogs

LOAEL = 1.4 mg/kg/day based on microscopic lens lesions (cataracts) in
eyes of female dogs. 

Cancer (oral, dermal, inhalation)	

Classification: Not Likely to be carcinogenic to humans 

UF = uncertainty factor; FQPA SF = FQPA SF; NOAEL = no observed adverse
effect level; LOAEL = lowest observed adverse effect level; PAD =
population adjusted dose (a = acute, c = chronic); RfD = reference dose.

VI.	Results/Discussion 

As stated above, for chronic dietary assessments, ARIA is concerned when
dietary risk exceeds 100% of the cPAD.  The DEEM-FCID( analyses estimate
the dietary exposure of the US population and various population
subgroups.  The results reported in Table 4 (below) are for the general
US population (total), all infants <1, children 1-2, children 3-5,
children 6-12, youths 13-19, females 13-49, adults 20-49, and adults 50+
for chronic exposure and females 13-49 for acute exposure.  

For the general population, there were no appropriate toxicological
effects attributable to a single exposure (dose); therefore, an acute
dose and endpoint were not identified for this risk assessment. 
Famoxadone has been classified as a “not likely carcinogen”;
therefore, quantification of human cancer risk is not required and a
cancer dietary assessment was not performed.

Results of Chronic Dietary Exposure Analysis

Famoxadone chronic dietary (food + water) exposure estimates using the
DEEM-FCID™ software are below ARIA’s level of concern for the U.S.
population and each of the population subgroups.  Chronic dietary
exposure utilized 47% of the cPAD for the U.S. population.  The chronic
dietary exposure for the highest reported exposed population subgroup,
adults 20-49 years old, was 59% of the cPAD.

The results of the acute and chronic dietary exposure analyses are
reported in the Summary Table (Table 4, below).

Table 4.  Summary of Dietary Exposure and Risk for Famoxadone.  

Population Subgroup1	DEEM Acute Dietary Analysis,

95th Percentile	DEEM Chronic Dietary Analysis

	Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% cPAD

General U.S. Population	

NA 2

	0.000658	47

All Infants (< 1 year old)

0.000414	30

Children 1-2 years old

0.000707	51

Children 3-5 years old

0.000614	44

Children 6-12 years old

0.000416	30

Youth 13-19 years old

0.000387	28

Adults 20-49 years old

0.000818	59

Adults 50+ years old

0.000597	43

Females 13-49 years old

0.000544	39

1 Values for the population with the highest risk for each type of risk
assessment are bolded.  

2 NA = Not Applicable; no acute dietary endpoint was identified for
these population subgroups.

VII.	Characterization of Inputs/Outputs

This analysis is a highly refined dietary exposure assessment.  Further
refinement to the analysis could be made through the use of additional
anticipated residues, incorporation of percentages of other crops
treated with famoxadone and/or monitoring data that better reflect
residues at the time of consumption.  Since risk estimates are below
ARIA’s level of concern, a more highly refined analysis is not needed
at this time.

VII.	Conclusions

Based on conservative assumptions, dietary risk estimates for famoxadone
do not exceed ARIA’s level of concern for the general U.S. population,
nor any of the population subgroups, including those comprised of
infants and children.  

VIII.	List of Attachments

Attachment 1:  Chronic Food plus Water Residue Input File

Attachment 2:  Chronic Results File

cc: Cynthia Giles-Parker

Attachment 1:  Chronic Food plus Water Residue Input File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FAMOXADONE                        
1994-98 data

Residue file: C:\Documents and Settings\bhanson\My Documents\Breann's
Work\ARIA\Famoxadone\Leafy Greens 4ALeaf Petioles 4B\Finals\113202.R98

                                                               Adjust.
#2 used

Analysis Date 07-08-2008             Residue file dated:
07-08-2008/12:49:11/8

Reference dose (RfD) = 0.0014 mg/kg bw/day

Comment:PP# 7E7280 and 7E7281 (2008)

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

04010050 4A   Amaranth, leafy                    1.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

04010180 4A   Arugula                            1.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

09020210 9B   Balsam pear                        0.050000   1.000     
1.000   Cucumb

  Full comment: Cucumber AR

21000470 M    Beef, fat                          0.007500   1.000     
1.000   AR Die

  Full comment: AR Diet = 0.05 ppm

21000471 M    Beef,fat-babyfood                  0.007500   1.000     
1.000   AR Die

  Full comment: AR Diet = 0.05 ppm

21000490 M    Beef, liver                        0.002850   1.000     
1.000   AR Die

  Full comment: AR Diet = 0.05 ppm

21000491 M    Beef, liver-babyfood               0.002850   1.000     
1.000   AR Die

  Full comment: AR Diet = 0.05 ppm

13010550 13A  Blackberry                         2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

13010560 13A  Blackberry, juice                  2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

13010561 13A  Blackberry, juice-babyfood         2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

13010580 13A  Boysenberry                        2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

09010750 9A   Cantaloupe                         0.130000   1.000     
1.000   Cantal

  Full comment: Cantaloupe AR

04020760 4B   Cardoon                            4.430000   1.000     
1.000   PP7E72

  Full comment: PP7E7280 Washed celery AR mean

09010800 9A   Casaba                             0.130000   1.000     
1.000   Cantal

  Full comment: Cantaloupe AR

04020850 4B   Celery                             4.430000   1.000     
0.390   PP7E72

  Full comment: PP7E7280 Washed celery AR mean

04020851 4B   Celery-babyfood                    4.430000   1.000     
0.390   PP7E72

  Full comment: PP7E7280 Washed celery AR mean

04020860 4B   Celery, juice                      4.430000   1.000     
0.390   PP7E72

  Full comment: PP7E7280 Washed celery AR mean

04020870 4B   Celtuce                            4.430000   1.000     
1.000   PP7E72

  Full comment: PP7E7280 Washed celery AR mean

09020880 9B   Chayote, fruit                     0.110000   1.000     
1.000   Summer

  Full comment: Summer Squash AR

09021020 9B   Chinese waxgourd                   0.050000   1.000     
1.000   Cucumb

  Full comment: Cucumber AR

19011030 19A  Chive                              6.110000   1.000     
1.000   PP#7E7

  Full comment: PP#7E7281 Green Onion AR

04011040 4A   Chrysanthemum, garland             1.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

19011180 19A  Coriander, leaves                  0.280000   1.000     
1.000   PP7E72

  Full comment: PP7E7280 Washed Lettuce w/o wrapper Mean AR

19011181 19A  Coriander, leaves-babyfood         0.280000   1.000     
1.000   PP7E72

  Full comment: PP7E7280 Washed Lettuce w/o wrapper Mean AR

04011330 4A   Cress, garden                      1.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

04011340 4A   Cress, upland                      1.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

09021350 9B   Cucumber                           0.050000   1.000     
0.050   Cucumb

  Full comment: Cucumber AR

04011380 4A   Dandelion, leaves                  1.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

13011420 13A  Dewberry                           2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

08001480 8    Eggplant                           0.350000   1.000     
1.000   Bell P

  Full comment: Bell Pepper AR

04011500 4A   Endive                             1.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

04021520 4B   Fennel, Florence                   4.430000   1.000     
1.000   PP7E72

  Full comment: PP7E7280 Washed celery AR mean

03001640 3    Garlic                             0.070000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Dry Bulb Mean AR

03001650 3    Garlic, dried                      0.070000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Dry Bulb Mean AR

03001651 3    Garlic, dried-babyfood             0.070000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Dry Bulb Mean AR

23001710 M    Goat, fat                          0.007500   1.000     
1.000   AR Die

  Full comment: AR Diet = 0.05 ppm

23001730 M    Goat, liver                        0.002850   1.000     
1.000   AR Die

  Full comment: AR Diet = 0.05 ppm

95001750 O    Grape                              0.440000   1.000     
0.050   Grape 

  Full comment: Grape AR mean

95001760 O    Grape, juice                       0.440000   0.010     
0.500   Grape 

  Full comment: Grape AR mean

95001761 O    Grape, juice-babyfood              0.440000   0.010     
0.500   Grape 

  Full comment: Grape AR mean

95001780 O    Grape, raisin                      0.440000   1.900     
1.000   Grape 

  Full comment: Grape AR mean

95001790 O    Grape, wine and sherry             0.440000   0.010     
0.050   Grape 

  Full comment: Grape AR mean

09011870 9A   Honeydew melon                     0.130000   1.000     
1.000   Cantal

  Full comment: Cantaloupe AR

95001880 O    Hop                               34.160000   1.000     
1.000   Hop AR

  Full comment: Hop AR mean

03001980 3    Leek                               6.110000   1.000     
1.000   PP#7E7

  Full comment: PP#7E7281 Green Onion AR mean

04012040 4A   Lettuce, head                      0.280000   1.000     
0.670   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x washing 

04012050 4A   Lettuce, leaf                      1.110000   1.000     
0.620   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

13012080 13A  Loganberry                         2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

27002220 D    Milk, fat                          0.005060   1.000     
1.000   

27002221 D    Milk, fat - baby food/infant for   0.005060   1.000     
1.000   

08002340 8    Okra                               1.310000   1.000     
1.000   Non-be

  Full comment: Non-bell Pepper AR

03002370 3    Onion, dry bulb                    0.070000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Dry Bulb AR mean

03002371 3    Onion, dry bulb-babyfood           0.070000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Dry Bulb AR mean

03002380 3    Onion, dry bulb, dried             0.070000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Dry Bulb AR mean

03002381 3    Onion, dry bulb, dried-babyfood    0.070000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Dry Bulb AR mean

03002390 3    Onion, green                       6.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Green Onion AR mean

04012480 4A   Parsley, leaves                    1.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

08002700 8    Pepper, bell                       0.350000   1.000     
0.050   Bell P

  Full comment: Bell Pepper AR

08002701 8    Pepper, bell-babyfood              0.350000   1.000     
0.050   Bell P

  Full comment: Bell Pepper AR

08002710 8    Pepper, bell, dried                0.350000   1.650     
0.050   Bell P

  Full comment: Bell Pepper AR

08002711 8    Pepper, bell, dried-babyfood       0.350000   1.650     
0.050   Bell P

  Full comment: Bell Pepper AR

08002720 8    Pepper, nonbell                    1.310000   1.000     
0.050   Non-be

  Full comment: Non-bell Pepper AR

08002721 8    Pepper, nonbell-babyfood           1.310000   1.000     
0.050   Non-be

  Full comment: Non-bell Pepper AR

08002730 8    Pepper, nonbell, dried             1.310000   1.650     
0.050   Non-be

  Full comment: Non-bell Pepper AR

01032960 1C   Potato, chips                      0.010000   1.000     
0.050   Potato

  Full comment: Potato AR

01032970 1C   Potato, dry (granules/ flakes)     0.010000   1.000     
0.050   Potato

  Full comment: Potato AR

01032971 1C   Potato, dry (granules/ flakes)-b   0.010000   1.000     
0.050   Potato

  Full comment: Potato AR

01032980 1C   Potato, flour                      0.010000   1.000     
0.050   Potato

  Full comment: Potato AR

01032981 1C   Potato, flour-babyfood             0.010000   1.000     
0.050   Potato

  Full comment: Potato AR

01032990 1C   Potato, tuber, w/peel              0.010000   1.000     
0.050   Potato

  Full comment: Potato AR

01032991 1C   Potato, tuber, w/peel-babyfood     0.010000   1.000     
0.050   Potato

  Full comment: Potato AR

01033000 1C   Potato, tuber, w/o peel            0.010000   1.000     
0.050   Potato

  Full comment: Potato AR

01033001 1C   Potato, tuber, w/o peel-babyfood   0.010000   1.000     
0.050   Potato

  Full comment: Potato AR

09023080 9B   Pumpkin                            0.110000   1.000     
0.050   Summer

  Full comment: Summer Squash AR

09023090 9B   Pumpkin, seed                      0.110000   1.000     
0.050   Summer

  Full comment: Summer Squash AR

04013130 4A   Radicchio                          1.110000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Washed Lettuce AR Mean x w/out wrapper

13013200 13A  Raspberry                          2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

13013201 13A  Raspberry-babyfood                 2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

13013210 13A  Raspberry, juice                   2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

13013211 13A  Raspberry, juice-babyfood          2.010000   1.000     
1.000   6E7099

  Full comment: 6E7099 AR mean

04023220 4B   Rhubarb                            4.430000   1.000     
1.000   PP7E72

  Full comment: PP7E7280 Washed celery AR mean

03003380 3    Shallot                            0.070000   1.000     
1.000   PP7E72

  Full comment: PP7E7281 Dry Bulb AR mean

26003410 M    Sheep, fat                         0.007500   1.000     
1.000   AR Die

  Full comment: AR Diet = 0.05 ppm

26003411 M    Sheep, fat-babyfood                0.007500   1.000     
1.000   AR Die

  Full comment: AR Diet = 0.05 ppm

26003430 M    Sheep, liver                       0.002850   1.000     
1.000   AR Die

  Full comment: AR Diet = 0.05 ppm

06003470 6    Soybean, seed                      0.020000   1.000     
1.000   Tolera

  Full comment: Tolerance level est for 18

06003480 6    Soybean, flour                     0.020000   1.000     
1.000   Tolera

  Full comment: Tolerance level est for 18

06003481 6    Soybean, flour-babyfood            0.020000   1.000     
1.000   Tolera

  Full comment: Tolerance level est for 18

06003490 6    Soybean, soy milk                  0.020000   1.000     
1.000   Tolera

  Full comment: Tolerance level est for 18

06003491 6    Soybean, soy milk-babyfood or in   0.020000   1.000     
1.000   Tolera

  Full comment: Tolerance level est for 18

06003500 6    Soybean, oil                       0.020000   1.000     
1.000   Tolera

  Full comment: Tolerance level est for 18

06003501 6    Soybean, oil-babyfood              0.020000   1.000     
1.000   Tolera

  Full comment: Tolerance level est for 18

04013550 4A   Spinach                            4.330000   1.000     
0.390   PP7E72

  Full comment: PP7E7281 Washed Spinach AR Mean x w/wrapper

04013551 4A   Spinach-babyfood                   4.330000   1.000     
0.390   PP7E72

  Full comment: PP7E7281 Washed Spinach AR Mean x w/wrapper

09023560 9B   Squash, summer                     0.110000   1.000     
0.010   Summer

  Full comment: Summer Squash AR

09023561 9B   Squash, summer-babyfood            0.110000   1.000     
0.010   Summer

  Full comment: Summer Squash AR

09023570 9B   Squash, winter                     0.110000   1.000     
0.010   Summer

  Full comment: Summer Squash AR

09023571 9B   Squash, winter-babyfood            0.110000   1.000     
0.010   Summer

  Full comment: Summer Squash AR

04023670 4B   Swiss chard                        4.430000   1.000     
1.000   PP7E72

  Full comment: PP7E7280 Washed celery AR mean

08003740 8    Tomatillo                          0.280000   1.000     
1.000   Tomato

  Full comment: Tomato AR

08003750 8    Tomato                             0.280000   1.000     
0.100   Tomato

  Full comment: Tomato AR

08003751 8    Tomato-babyfood                    0.280000   1.000     
0.100   Tomato

  Full comment: Tomato AR

08003760 8    Tomato, paste                      0.280000   1.300     
0.100   Tomato

  Full comment: Tomato AR

08003761 8    Tomato, paste-babyfood             0.280000   1.300     
0.100   Tomato

  Full comment: Tomato AR

08003770 8    Tomato, puree                      0.280000   0.400     
0.100   Tomato

  Full comment: Tomato AR

08003771 8    Tomato, puree-babyfood             0.280000   0.400     
0.100   Tomato

  Full comment: Tomato AR

08003780 8    Tomato, dried                      0.280000   1.650     
0.100   Tomato

  Full comment: Tomato AR

08003781 8    Tomato, dried-babyfood             0.280000   1.650     
0.100   Tomato

  Full comment: Tomato AR

08003790 8    Tomato, juice                      0.280000   0.300     
0.100   Tomato

  Full comment: Tomato AR

86010000 O    Water, direct, all sources         0.000189   1.000     
1.000   DP 347

  Full comment: DP 347671, 347674

86020000 O    Water, indirect, all sources       0.000189   1.000     
1.000   DP 347

  Full comment: DP 347671, 347674

09013990 9A   Watermelon                         0.130000   1.000     
0.010   Cantal

  Full comment: Cantaloupe AR

09014000 9A   Watermelon, juice                  0.130000   1.000     
0.010   Cantal

  Full comment: Cantaloupe AR

Attachment 2:  Chronic Results File

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\bhanson\My
Documents\Breann's Work\ARIA\Famoxadone\Leafy Greens 4ALeaf Petioles
4B\Finals\113202.R98

                                                     Adjustment factor
#2 used.

Analysis Date 07-08-2008/12:50:01     Residue file dated:
07-08-2008/12:49:11/8

Reference dose (RfD, Chronic) = .0014 mg/kg bw/day

COMMENT 1: PP# 7E7280 and 7E7281 (2008)

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000658               
47.0%

U.S. Population (spring season)             0.000724               
51.7%

U.S. Population (summer season)             0.000687               
49.0%

U.S. Population (autumn season)             0.000594               
42.4%

U.S. Population (winter season)             0.000629               
45.0%

Northeast region                            0.000632               
45.2%

Midwest region                              0.000648               
46.3%

Southern region                             0.000575               
41.1%

Western region                              0.000821               
58.7%

Hispanics                                   0.000602               
43.0%

Non-hispanic whites                         0.000684               
48.9%

Non-hispanic blacks                         0.000460               
32.9%

Non-hisp/non-white/non-black                0.000916               
65.4%

All infants (< 1 year)                      0.000414               
29.6%

Nursing infants                             0.000177               
12.6%

Non-nursing infants                         0.000505               
36.0%

Children 1-6  yrs                           0.000621               
44.4%

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Children 7-12 yrs                           0.000402               
28.7%

Females 13-19 (not preg or nursing)         0.000296               
21.2%

Females 20+ (not preg or nursing)           0.000574               
41.0%

Females 13-50 yrs                           0.000563               
40.2%

Females 13+ (preg/not nursing)              0.000336               
24.0%

Females 13+ (nursing)                       0.000483               
34.5%

Males 13-19 yrs                             0.000475               
33.9%

Males 20+ yrs                               0.000921               
65.8%

Seniors 55+                                 0.000563               
40.2%

Children 1-2 yrs                            0.000707               
50.5%

Children 3-5 yrs                            0.000614               
43.9%

Children 6-12 yrs                           0.000413               
29.5%

Youth 13-19 yrs                             0.000387               
27.6%

Adults 20-49 yrs                            0.000818               
58.4%

Adults 50+ yrs                              0.000597               
42.7%

Females 13-49 yrs                           0.000544               
38.8%

Famoxadone	                       Dietary Exposure and Risk Assessment  
            DP Numbers: 354336 &354337	

PC Code: 113202

________________________________________________________________________
______________

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	Page   PAGE  10  of   NUMPAGES  17