Document ID: EPA-HQ-OPP-2006-0332-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-05-23T04:00Z

UNITED STAES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

 PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	11/6/06

SUBJECT:	Famoxadone Chronic Dietary Exposure Assessment for the Use on
Grapes, Hops, and Caneberries.

PC Code:		113202

Decision Number: 	369719

DP Number:		332298

REVIEWER:	W. Cutchin, Acting Branch Senior Scientist 

Alternative Risk Integration and Assessment (ARIA) Team

Technical Review Branch (TRB) 				

Registration Division (RD) (7505P)

	and

	B. Hanson, Biologist 

ARIA

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

THROUGH:	D. Dotson, Chemist

D. Soderberg, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (HED) (7509P)

TO:	S. Brothers, RM 05

	RIMUERB/RD (7505P)

Executive Summary

The purpose of this memorandum is to report the results of a chronic
dietary exposure analysis for Interregional Research Project No. 4
(IR-4) petitions for the fungicide famoxadone for a domestic
registration for the use on grapes east of the Rocky Mountains, hops,
and caneberries, subgroup 13A (PP#5E7001 & 6E7099).  The 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.  

Acute Dietary Exposure Results and Characterization 

In meetings on December 5, 2002 and April 4, 2003 HED’s Hazard
Identification Assessment Review Committee (HIARC) 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 Exposure Results and Characterization

The Tier 1 chronic dietary risk assessment for famoxadone showed that
dietary risk estimates exceeded HED's level of concern (i.e. >100%
chronic population adjusted doses (cPAD)); therefore, a partially
refined chronic dietary assessment was performed using anticipated
residues (ARs) and with use of percent crop treated (%CT) information
from the Biological and Economic Analysis Division (BEAD).  The refined
assessment shows that for all included commodities, the chronic dietary
risk estimates are below HED's level of concern (i.e. <100% cPAD).  The
highest chronic drinking water concentration of 0.47 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 HED’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, children
1-2 years old, is 65% of the cPAD.  The general US population utilizes
51% of the cPAD.

Cancer 

The HIARC 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.  This is the
population adjusted dose (PAD), which HED has concluded will result in
no unreasonable adverse health effects.  The PAD is the Reference Dose
(RfD) divided by the FQPA Safety Factor.  Dietary risk is expressed as a
percentage of the PAD.  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,”
6/21/2000, web link: 
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
D. McNeilly (DP Number: 321684, 04/17/2006) for its use on soybean to
control soybean rust.  The first dietary risk assessment for famoxadone
was conducted in connection with Section 3 registration of fruiting
vegetables, cucurbit vegetables, head lettuce, and potatoes and an
import tolerance for grapes (DP Number: 288138, M. Doherty, 04/18/2003).

II.	Residue Information

Famoxadone Use

In this analysis the chronic dietary exposure and risk estimates
resulting from food intake were determined for the general U.S.
population and various population subgroups resulting from the addition
of a domestic registration for the use on grapes east of the Rocky
Mountains, hops, and caneberries, subgroup 13A to the existing food uses
for famoxadone.

Permanent tolerances for famoxadone have been established in 40 CFR
§180.587.  Temporary tolerances have been established for
soybean/soybean commodities.  Current tolerances range from 0.02 ppm in
cattle, goat, horse and sheep fat to 10 ppm in lettuce.  

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 for use of
famoxadone on caneberry, the residue of concern for tolerance expression
and risk assessment purposes is considered to be the parent compound. 

Residue Data Used for Chronic Assessments

The previous 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 Number: 287253, M.
Doherty, 4/16/2003).  The assessments assumed 100% crop treated for all
commodities.  Those residue levels and processing factors used in the
previous dietary exposure analyses are shown in Table 1.  

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

RAC	

Food Form	

Residue Level, ppm	

Processing Factor	

Comments

Grape	

RAC	

0.67	

Not Applicable	

Grape AR

Grape	

Juice	

0.67	

0.01	

Grape AR

Grape	

Raisin	

0.67	

1.9	

Grape AR

Grape	

Wine and Sherry	

0.67	

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	

0.55	

Not Applicable	

Lettuce AR (w/o wrapper)

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

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

Cucumber	

RAC	

0.05	

Not Applicable	

Cucumber AR

Honeydew melon	

RAC	

0.13	

Not Applicable	

Cantaloupe 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

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 partially refined dietary exposure analysis used a Screening-Level
Usage Analysis (SLUA), provided by the Biological and Economic Analysis
Division (BEAD), for %CT information of current uses of famoxadone (J.
Alsadek, 08/31/2006).  This information is listed in Table 2, below.

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

Commodity	Percent of Crop Treated

Cucumbers	5

Peppers	5

Potatoes	5

Pumpkins	5

Squash

	<1

Tomatoes	10

Watermelons	<1

As part of the current petition, ARIA recommends establishing the
permanent tolerances listed in Table 3 for residues of famoxadone.  The
dietary assessment used the highest average field trial (HAFT) level for
hops and caneberries.  The existing ARs for grape commodities were also
used since the data used for the existing tolerance without a domestic
registration was used in support of the proposed use on grapes east of
the Rocky Mountains.

Table 3.   Proposed Tolerance Summary and AR for Famoxadone             
         

Commodity	Proposed Tolerance	AR

Grapes	2.50	Existing AR

Hops	80	45.66

Caneberries, subgroup 13A

	   10 ppm	6.05

III.  	Drinking Water Data

For this chronic dietary exposure analysis, residues in water were
included directly in the DEEM analysis.  The Environmental Fate and
Effects Division (EFED) sent a memorandum (P. Jennings, 8/31/2005)
stating that the estimated drinking water concentrations (EDWCs)
appropriate for chronic exposure comparisons are 0.47 μg/L (ppb) in
surface water and 0.23 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 registered potato use
because it has the highest application rate, 0.1875 lbs ai/acre, with 6
applications at 5 day intervals.  The PRZM/EXAMS Model was used to
estimate surface water concentrations and the SCIGROW Model was used to
estimate groundwater concentrations.

.	DEEM-FCID™ Program and Consumption Information

The famoxadone chronic dietary 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.  Consumption data are averaged for the
entire U.S. population and within population subgroups for chronic
exposure assessment, but are retained as individual consumption events
for acute exposure assessment.

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 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 exposure and risk 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.  The resulting residue
consumption estimate for each food/food form is summed with the residue
consumption 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

In meetings on December 5, 2002 and April 4, 2003 HED’s Hazard
Identification Assessment Review Committee 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 4, 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 4.  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 

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 the Summary Table (Table 5) 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.  

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.  The
HIARC classified famoxadone as a “not likely carcinogen”; therefore,
quantification of human cancer risk is not required and a cancer dietary
assessment was not performed.

Results of the Chronic Dietary Exposure Analysis

The chronic dietary exposure for food and surface water utilized 51% of
the cPAD for the U.S. population.  The chronic dietary exposure for the
highest reported exposed population subgroup, children 1-2 years old,
was 65% of the cPAD.

Table 5.  Summary of Dietary Exposure and Risk for Famoxadone

Population Subgroup	Acute Dietary

(95.0 Percentile)	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD*	Dietary Exposure

(mg/kg/day)	% cPAD*	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	N/A	0.000712	51	N/A

All Infants (< 1 year old)

0.000232	17

	Children 1-2 years old

0.000915	65

	Children 3-5 years old

0.000842	60

	Children 6-12 years old

0.000517	37

	Youth 13-19 years old

0.000424	30

	Adults 20-49 years old

0.000883	63

	Adults 50+ years old

0.000583	42

	Females 13-49 years old

0.000524	37

	* % PADs are reported to 2 significant figures.

* *The values for the highest exposed population for each type of risk
assessment are bolded.

These analyses are partially refined dietary exposure assessments. 
Further refinement to the analyses could be made through the use of
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
HED’s level of concern, a more highly refined analysis is not needed
at this time.

VII.	Conclusions

A chronic dietary exposure assessment was conducted for the proposed and
existing food uses and drinking water from surface water sources.  

  

The chronic dietary (food + drinking water) exposure to famoxadone is
below HED’s level of concern for the general U.S. population and all
population subgroups.  The chronic dietary exposure utilized 51% cPAD
for the general U.S. population and 65% cPAD for children 1-2 years old,
the most highly exposed population subgroup. 

VIII.	List of Attachments

Attachment 1:  Chronic Food plus Water Residue Input File

Attachment 2:  Chronic Results File

Attachment 3:  Famoxadone SLUA

cc:  B. Hanson

Attachment 1:  Chronic Food plus Water Residue Input File

                                                            

Filename: I:\working\Famox\113202_3.R98                    Chemical:
Famoxadone

RfD(Chronic): .0014 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 10-25-2006/15:25:20/8          Program ver.
2.03

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

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                         6.050000   1.000  1.000
 6E7099

13010560 13A  Blackberry, juice                  6.050000   1.000  1.000
 6E7099

13010561 13A  Blackberry, juice-babyfood         6.050000   1.000  1.000
 6E7099

13010580 13A  Boysenberry                        6.050000   1.000  1.000
 6E7099

09010750 9A   Cantaloupe                         0.130000   1.000  1.000
 Cantal

          Full comment: Cantaloupe AR

09010800 9A   Casaba                             0.130000   1.000  1.000
 Cantal

          Full comment: Cantaloupe AR

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

09021350 9B   Cucumber                           0.050000   1.000  0.050
 Cucumb

          Full comment: Cucumber AR

13011420 13A  Dewberry                           6.050000   1.000  1.000
 6E7099

08001480 8    Eggplant                           0.350000   1.000  1.000
 Bell P

          Full comment: Bell Pepper 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                              0.670000   1.000  1.000
 Grape 

          Full comment: Grape AR

95001760 O    Grape, juice                       0.670000   0.010  1.000
 Grape 

          Full comment: Grape AR

95001761 O    Grape, juice-babyfood              0.670000   0.010  1.000
 Grape 

          Full comment: Grape AR

95001780 O    Grape, raisin                      0.670000   1.900  1.000
 Grape 

          Full comment: Grape AR

95001790 O    Grape, wine and sherry             0.670000   0.010  1.000
 Grape 

          Full comment: Grape AR

09011870 9A   Honeydew melon                     0.130000   1.000  1.000
 Cantal

          Full comment: Cantaloupe AR

95001880 O    Hop                               45.660000   1.000  1.000
 

04012040 4A   Lettuce, head                      0.550000   1.000  1.000
 Lettuc

          Full comment: Lettuce AR (w/o wrapper)

13012080 13A  Loganberry                         6.050000   1.000  1.000
 6E7099

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

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

13013200 13A  Raspberry                          6.050000   1.000  1.000
 6E7099

13013201 13A  Raspberry-babyfood                 6.050000   1.000  1.000
 6E7099

13013210 13A  Raspberry, juice                   6.050000   1.000  1.000
 6E7099

13013211 13A  Raspberry, juice-babyfood          6.050000   1.000  1.000
 6E7099

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

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

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         0.000470   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.000470   1.000  1.000
 

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: I:\working\Famox\113202_3.R98     Adjustment factor
#2 used.

Analysis Date 10-26-2006/12:41:59     Residue file dated:
10-25-2006/15:25:20/8

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

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000712               
50.9%

U.S. Population (spring season)             0.000768               
54.9%

U.S. Population (summer season)             0.000835               
59.6%

U.S. Population (autumn season)             0.000622               
44.5%

U.S. Population (winter season)             0.000624               
44.6%

Northeast region                            0.000644               
46.0%

Midwest region                              0.000764               
54.5%

Southern region                             0.000615               
43.9%

Western region                              0.000874               
62.4%

Hispanics                                   0.000620               
44.3%

Non-hispanic whites                         0.000776               
55.4%

Non-hispanic blacks                         0.000464               
33.1%

Non-hisp/non-white/non-black                0.000601               
43.0%

All infants (< 1 year)                      0.000232               
16.6%

Nursing infants                             0.000144               
10.3%

Non-nursing infants                         0.000266               
19.0%

Children 1-6  yrs                           0.000837               
59.8%

Children 7-12 yrs                           0.000490               
35.0%

Females 13-19 (not preg or nursing)         0.000331               
23.7%

Females 20+ (not preg or nursing)           0.000532               
38.0%

Females 13-50 yrs                           0.000556               
39.7%

Females 13+ (preg/not nursing)              0.000295               
21.1%

Females 13+ (nursing)                       0.000490               
35.0%

Males 13-19 yrs                             0.000513               
36.7%

Males 20+ yrs                               0.001042               
74.4%

Seniors 55+                                 0.000526               
37.6%

Children 1-2 yrs                            0.000915               
65.4%

Children 3-5 yrs                            0.000842               
60.2%

Children 6-12 yrs                           0.000517               
36.9%

Youth 13-19 yrs                             0.000424               
30.3%

Adults 20-49 yrs                            0.000883               
63.1%

Adults 50+ yrs                              0.000583               
41.6%

Females 13-49 yrs                           0.000524               
37.4%

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

Attachment 3:  Famoxadone SLUA

Famoxadone (PC 113202)

Screening-level Usage Analysis (SLUA)

Date:  August 31, 06

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active
ingredient that is used on agricultural crops in the United States.

What does it contain?

Pesticide usage data for a single active ingredient only.

Agricultural use sites (crops) that the pesticide is reported to be used
on. 

Available pesticide usage information (i.e., does not include all of the
United States).

Annual percent of crop treated (average & maximum) for each agricultural
crop.

Average annual pounds of the pesticide applied for each agricultural
crop (i.e., for the states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

Average pounds of active ingredient applied - Values are calculated by
merging pesticide usage data sources together; averaging by year,
averaging across all years, & then rounding.  Note:  If the estimated
value is less than 500, then that value is labeled <500.  Estimated
values between 500 & <1,000,000 are rounded to 1 significant digit. 
Estimated values of 1,000,000 or greater are rounded to 2 significant
digits.)

Average percent of crop treated - Values are calculated by merging data
sources together; averaging by year, averaging across all years, &
rounding to the nearest multiple of 5.  Note:  If the estimated value is
less than 1, then the value is labeled <1.

Maximum percent of crop treated - Value is the single maximum value
reported across all data sources, across all years, & rounded up to the
nearest multiple of 5.  Note:  If the estimated value is less than 2.5,
then the value is labeled <2.5.

What are the data sources used?

USDA-NASS (United States Department of Agriculture’s National
Agricultural Statistics Service) – pesticide usage data from 1999 to
2004.

Private Pesticide Market Research – pesticide usage data from 1999 to
2004.

NCFAP 97 (National Center for Food and Agricultural Policy), and NPUD
2002 (National Pesticide Use Database) – insecticide usage data from
NCFAP 97, and fungicide and herbicide usage data from NPUD 02, of the
CropLife Foundation,  are used only if data are not available from the
other sources.

California DPR data can be requested separately.

What are the data limitations?

Additional registered uses may exist but are not included because the
available surveys do not report usage (e.g., small acreage crops).

Lack of reported usage data for the pesticide on a crop does not imply
zero usage.

Usage data on a particular site may be noted in data sources, but not
quantified.  In these instances, the site would not be reported in the
SLUA.

Non-agricultural use sites (e.g., turf, post-harvest, mosquito control,
etc.) are not reported in the SLUA.  A separate request must be made to
receive these estimates.

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☊଀ن㜀Ĥ␸䠁Ĥ᠀Some sites show some use, even though they are
not on the label.  This usage could be due to Section 18 requests,
existing stocks of the chemical, data collection errors, experimental
use permit (EUP), and/or because of an illegal use. 

Who do I contact for further information and/or questions on this SLUA?

Jihad Alsadek (703-308-8140)

Alan Halvorson (703-308-8070)

                                      Thursday, August 31, 2006 12:35  
       	  	 		

Screening Level Estimates of Agricultural Uses of famoxadone

Sorted Alphabetically

	  	 		

	  	 	Pounds of	Percent      Maximum

	  	 	Active	of Crop     Percent of

		Crop	Ingredient	Treated    Crop Treated

	  	 		

	1 	Cucumbers	1,000	 5             10

	2 	Peppers	2,000	 5              5

	3 	Potatoes	5,000	 5              5

	4 	Pumpkins	2,000	 5              5

	5 	Squash	<500	<1              5

	6 	Tomatoes	6,000	10             20

	7 	Watermelons	1,000	<1           <2.5

	  	 		

______________________________________		

	  	 		

All numbers rounded.		

'<500' indicates less than 500 pounds of active ingredient.		

'<2.5' indicates less than 2.5 percent of crop is treated.		

'<1'	indicates less than 1	percent of crop is treated.	

Famoxadone		DP Number: 332298	

PC Code: 113202	

________________________________________________________________________
______________

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