Document ID: EPA-HQ-OPP-2006-0331-0011
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-07-11T04:00Z

SEQ CHAPTER \h \r 1 

     

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

                                                                        
                                                                        
                                            

                                                                        
                                                                        
        			      OFFICE OF     

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:   	05/DEC/2006 

SUBJECT:	Cymoxanil: Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure Assessment for the Proposed IR-4 Uses on
Grapes, Hops (PP # 5E7000) and Caneberries (PP # 6E7100).

PC Code:	129106			Decision Number: 369731

DP Num: 	333189

REVIEWER:	Eugenia McAndrew, Biologist

Risk Integration, Minor Use and Emergency Response Branch 

Registration Division (7505P)

THROUGH:	Amelia Acierto

		Thurston Morton

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

TO:		Shaja Brothers

		Risk Integration, Minor Use and Emergency Response Branch 

Registration Division (7505P)

Executive Summary

ion 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.  The analyses
were performed to support the proposed IR-4 tolerance petitions for the
use of cymoxanil on grapes, hops and caneberries.

The unrefined acute analysis (females 13-49 years old only) assumed that
cymoxanil residues are present in all registered food commodities at
tolerance levels and that 100% of all commodities are treated.  DEEM
version 7.81 default processing factors were used for all registered and
proposed commodities except for grape juice and raisins where the
default concentration factors were set to 1 (see memo S. Chun; DP Num:
248603; 02/SEPT/1998). For risk assessment purposes for lettuce and
hops, the metabolite IN-KQ960 was included, along with the parent, based
on the ratio of IN-KQ960 to the parent (3.5) in the lettuce metabolism
study (i.e., the recommended tolerance level was multiplied by 3.5 to
account for IN-KQ960).  

The partially refined chronic analysis was conducted for the general
U.S. population and all population subgroups using mean tolerance level
residues for all commodities except lettuce and residues for lettuce
field trials conducted at the highest application rate (1.3125 lb. ai/A)
(MRID 44946430, S. Levy, 20/NOV/2002). Exposure estimates were further
refined based on screening-level percent crop treated (% CT) data for
several registered commodities and projected % crop treated data for
grapes.  

Drinking water was incorporated directly into the dietary assessment
using the estimated drinking water concentrations (EDWC).  EDWCs were
generated using the FIRST (version 1.0) model for surface water.  For
the acute assessment, a concentration of 0.019 ppm was used; for the
chronic assessment, the value of 0.0001 ppm was used.

Acute Dietary Exposure Results

The unrefined acute dietary exposure assessment was performed for
females 13-49 years old only, since an acute endpoint of concern was not
identified for the general U.S. population.  Based on the assumptions
described above, acute dietary exposure of females 13-49 years old is
below ARIA’s level of concern at the 95th percentile of exposure. 
Combined dietary exposure from food and drinking water is estimated at
0.028791 mg/kg/day, equivalent to 72 % of the acute Population Adjusted
Dose (aPAD).

Chronic Dietary Exposure Results 

™ software, dietary exposure is estimated at 0.000414 mg/kg/day for
the general U.S. population (52% of the chronic Population Adjusted Dose
(cPAD)) and 0.000560 mg/kg/day (70% of the cPAD) for adults 20-49 years,
the population subgroup with the highest estimated chronic dietary
exposure to cymoxanil.  

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  For acute and chronic assessments, the risk is
expressed as a percentage of a maximum acceptable dose (i.e., the dose
which HED has concluded will result in no unreasonable adverse health
effects).  This dose is referred to as the population adjusted dose
(PAD).  The PAD is equivalent to the reference dose (RfD) divided by the
special Food Quality Protection Act (FQPA) Safety Factor.

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:      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 HED dietary risk assessment for cymoxanil (S. Levy, DP
Num: 276292, 04/DEC/2002) was conducted to support the FIFRA §3 food
uses on hops, lychee, fruiting vegetables, head lettuce and cucurbits.
The current assessment incorporates drinking water directly into the
dietary analyses using the EDWCs calculated for the proposed tolerances
on grapes, hops and caneberries. 

Food Residue Information

A. Tolerance Expression and Residues of Concern for the
Registered/Proposed Crops

An ad hoc MARC met on 21/JAN/1998 and decided that parent only is of
regulatory concern (G. Kramer, et. al., DP Num: 242321, 26/JAN/1998) in
tomatoes, potatoes, grapes, livestock, rotational crops and drinking
water. Subsequent to the initial MARC meeting, the petitioner submitted
a lettuce metabolism study (MRID 44944605). Metabolites IN-KQ960 and
IN-KP533 are present in the lettuce metabolism study which were not
present in the tomato, grape, potato or rat metabolism studies. The
lettuce metabolism results were presented to the HED MARC to assess the
toxicological significance of these metabolites and to determine which
additional residues, if any, to regulate in lettuce. 

The MARC concluded (S. Levy, DP Num: 276796, 30/AUG/2001) that for the
tolerance expression the residue of concern in/on hops is cymoxanil per
se. For risk assessment purposes for hops and lettuce, the metabolite
IN-KQ960 must be included, along with the parent, based on the ratio of
IN-KQ960 to the parent in the lettuce 14C metabolism study. For any
future petitions for tolerance on leafy vegetables, the petitioner was
instructed to include residue data for IN-KQ960. The final decision
concerning the tolerance expression in lettuce and other leafy
vegetables is deferred pending results of the residue studies. 

Tolerances are currently established under 40 CFR 180.503 for grape (0.1
ppm, imports only), hop, dried cones (1.0 ppm), lettuce, head (4.0 ppm),
lychee (1.0 ppm), potato, (0.05 ppm), vegetable, cucurbit, group 9 (0.05
ppm) and vegetable, fruiting, group 8 (0.2 ppm). IR-4 has proposed
adding caneberries (4 ppm) and increasing the grape tolerance to 1 ppm
and the dried hop tolerance to 5 ppm. The increased tolerance for grapes
is being requested to support domestic use of cymoxanil on grapes. The
increased tolerance for dried hop is being requested to support a
different formulation which results in higher field trials. ARIA has
reviewed the residue chemistry data associated with the current request.
These data do not support increasing the tolerance for grapes from 0.1
to 1.0 ppm.  The data indicate that the tolerance for hop should be
increased from 1.0 to 7.0 ppm. ARIA concludes that the following
tolerances for residues of cymoxanil are appropriate (D. Rate, DP Num:
324447)

Grape 			0.1 ppm

Hop, dried cones	7.0 ppm  

Caneberries		4.0 ppm          

B. Residue Data used in the Acute and Chronic Dietary Analyses

Acute:  Tolerance level residues and 100% CT were assumed for all plant
commodities. DEEM (ver.7.81) default processing factors were assumed for
all registered and proposed commodities except for grape juice and
raisins where the default concentration factors were set to 1 (see S.
Chun, DP Num: 248603, 02/SEPT/1998 for details). For risk assessment
purposes for lettuce and hops, the metabolite IN-KQ960 was included,
along with the parent, based on the ratio of IN-KQ960 to the parent
(3.5) in the lettuce metabolism study (i.e., the recommended tolerance
level was multiplied by 3.5 to account for IN-KQ960). 

Table # 1.  Residue Data used in the Acute Dietary Analysis for
Cymoxanil

Commodity	Tolerance

(Tolerance + Metabolite)	Percent Crop Treated	Processing Factors

Grape	0.1  ppm	100	Juice (1x)

Raisins (1x)

Hop, dried cones	           7.0  ppm 

        (31.5  ppm)	100	1x

Lettuce, head	           4.0 ppm

(18  ppm)	100	1x

Lychee	          1.0   ppm	100	Dried  1.85

Potato	          0.05 ppm	100	Dried  6.5

Cucurbit Vegetables (Group 9)	          0.05 ppm	100	1x

Fruiting vegetables

(Group 8)	          0.2  ppm	100	Tomato paste  5.4

Tomato puree 3.3

Tomato dried 14.3

Tomato juice  1.5

Caneberries

(Subgroup 13A)	           4    ppm	100	1x

Chronic:

The partially refined chronic dietary exposure analysis incorporated
mean field trial residues of cymoxanil for lettuce (with wrapper leaves)
from trials conducted at the highest application rate (1.3125 lb. ai/A)
(MRID 44946430, S. Levy, 20/NOV/2002).  Tolerance level residues were
used for all other commodities. Exposure estimates were further refined
based on screening-level percent crop treated (% CT) data provided by
BEAD for cucumbers, lettuce, peppers, potatoes, pumpkins, squash,
tomatoes and watermelons [Cymoxanil Screening- level Usage Analysis
(SLUA),  J. Carter, 02/NOV/2006].  A conservative projected % crop
treated estimate of 10% was used for grapes. Cymoxanil is proposed for
use only on grapes grown east of the Rocky Mountains. USDA production
statistics for grapes indicate that in 2003, 2004 and 2005 more than 93%
of U.S. grapes were produced in two West Coast states (California and
Washington) [USDA NASS Non-Citrus Fruits and Nuts; 2005 Summary; FrNt
1-3 (06)].  Therefore, ARIA conservatively estimates that even if all of
the grapes grown east of the Rockies were treated with cymoxanil, less
than 10% of the grapes would be treated. 

Table # 2.  Residue Data used in the Chronic Dietary Analysis for
Cymoxanil

Commodity	Residue	Percent Crop Treated	Processing Factors

Grape	0.1  ppm 

(tolerance)	             10	Juice (1x)

Raisins (1x)

Hop, dried cones1	31.5 ppm 

(tolerance + metabolite)	            100	1x

Lettuce, head 2	 3.15 ppm 

(average field trial + metabolite)	              10	1x

Lychee	 1.0   ppm (tolerance)	             100	Dried  1.85

Potato	 0.05 ppm (tolerance)	               10	Dried  6.5

Cucurbit Vegetables (Group 9)	 0.05 ppm (tolerance)	Cucumber       10

Pumpkin           1

Squash              1

Watermelon      1

All others      100	1x

Fruiting vegetables

(Group 8)	 0.2  ppm (tolerance)	Tomatoes        10

Peppers           10

All others      100

	Tomato paste  5.4

Tomato puree 3.3

Tomato dried 14.3

Tomato juice  1.5

Caneberries

(Subgroup 13A)	  4.0 ppm (tolerance)	              100	1x

 

1 Tolerance + (3.5 x Tolerance) = 7 ppm + ( 3.5 x 7) = 31.5 ppm

2 Average FT + (3.5 x Average FT) = 0,7 ppm + (3.5 x 0.7 ppm) = 3.15 ppm

 Drinking Water Data 

References: IR-4 Tolerance Petition for Cymoxanil (Tanos) Use on Grapes,
Hops: DW Assessment; D.Young and T. Steeger, 20/SEPT/2006, DP Num:
323681 and IR-4 Tolerance Petition for Cymoxanil (Tanos) Use on
Caneberries: DW Assessment; D.Young and T. Steeger,  21/SEPT/2006, DP
Num: 331978

The Environmental Fate and Effects Division (EFED) calculated screening
level surface water and ground water estimates for cymoxanil using FIRST
(version 1.0) model and the SCI-GROW model, respectively. The drinking
water models and their descriptions are available at the EPA internet
site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .  The newly proposed
application rate for caneberries is less than the rates evaluated for
the new use of cymoxanil on grapes and hops. Therefore no new drinking
water concentrations are needed for the proposed use. The newly proposed
application rates for use on grapes and hops are higher than the rates
evaluated in the previous Section 3 registration for the use of
cymoxanil on potatoes (DP Num: 233366) and for the initial IR-4
tolerance petition for use of cymoxanil (Curzate 60 DF) on hops (DP Num:
271572).  Therefore new drinking water concentrations were determined
for the proposed uses. Tier 1 drinking water concentrations (EDWCs)
based on the newly proposed application rate for grapes appear in Table
3 as follows:

Table #3.  Estimated drinking water concentrations for Cymoxanil1

	Acute  (ppm)	Chronic  (ppm)

Groundwater	0.000003	0.000003

Surface Water	0.019	0.0001

1 Concentrations determined from the grape application (0.25 lbs per
acre, 10 times), which was the highest application rate reported for the
new proposed uses.

For the purpose of these dietary assessments, ARIA used 0. 019 ppm for
the acute analysis and 0.0001 ppm for the chronic analysis.  For both
the acute and chronic analyses, the drinking water EDWC was incorporated
directly as a point estimate in the
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IV.	DEEM-FCID™ Program and Consumption Information

Cymoxanil 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 assessments, 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.

Toxicological Information

This memo updates the previous memo with a new toxicological endpoint
for the chronic assessment. 

.

Table # 4.  Summary of Cymoxanil Toxicological Doses and Endpoints for
Dietary Risk Assessment

Exposure

Scenario	

Dose Used in Risk Assessment, UF 	

Special FQPA SF* and Level of Concern for Risk Assessment	

Study and Toxicological Effects

Acute Dietary

(Females 13-50 years of age)	

NOAEL = 4 mg/kg

UF = 100

Acute RfD = 0.04 mg/kg	

FQPA SF = 1X

aPAD = acute RfD

              FQPA SF

= 0.04 mg/kg	

Developmental Toxicity (rabbit)

Offspring LOAEL = 8 mg/kg/day  based on increased skeletal malformations
of he cervical and thoracic vertebrae and ribs

Acute Dietary

(General population including infants and children)	

NOAEL = NA

UF = NA

Acute RfD = NA 	

FQPA SF =  NA

aPAD = acute RfD

              FQPA SF

= NA	

Not Required.  An endpoint of concern (effect) attributable to a single
dose was not identified in the database. 

Chronic Dietary

(All populations)	

NOAEL< 0.8 mg/kg/day

UF = 100

Chronic RfD = 0.008

 mg/kg/day	

FQPA SF1 = 10X

(includes UFL =  10X 

cPAD = chronic RfD

               FQPA SF

= 0.0008 mg/kg/day	

Chronic toxicity (dog; 2003)

LOAEL = 1.3/0.8 mg/kg/day (M/F), based on decreased absolute and
relative thymus weights and histopathology of the thymus (thymic
atrophy/involution) in males and decreased thymus weights in females

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL =
no-observed-adverse-effect-level, LOAEL =
lowest-observed-adverse-effect-level, PAD = population adjusted dose (a
= acute, c = chronic) RfD = reference dose, NA = Not Applicable 

1  The 10X FQPA SF has been retained in the form of UFL to account for
the use of a LOAEL to extrapolate a NOAEL

VI.	Results/Discussion 

As stated above, for acute and chronic assessments, ARIA 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 acute exposure results are reported in Table
# 5 for females 13-49 only.  The chronic results reported in Table # 6
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.  

Results of Acute Dietary Exposure Analysis

The unrefined acute dietary (food + drinking water) exposure assessment
was performed for females 13-49 years old only, since an acute endpoint
of concern was not identified for the general population.  Based on the
assumptions described above in sections II and III, acute dietary
exposure of females 13-49 years old is below ARIA’s level of concern
(i.e., <100% of the aPAD of 0.04 mg/kg).  The combined dietary exposure
from food and drinking water is estimated at 0.028791 mg/kg/day (72% of
the aPAD), at the 95th percentile of exposure, the appropriate
regulatory statistic for Tier 1 dietary assessments.  

Table # 5.  Results of Acute Dietary Exposure Analysis Using DEEM FCID 

Population Subgroup	aPAD (mg/kg/day)	95th Percentile	99th Percentile
99.9th Percentile

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

Females 13-49 years old 	0.04	0 .028791	72	0.051094	128	0.108653	272

Results of Chronic Dietary Exposure Analysis

-FCID™ software are below ARIA’s level of concern for the general
U.S. population and each of the population subgroups.  Dietary exposure
was estimated at 0.000414 mg/kg/day for the U.S. population         (52%
of the cPAD) and 0.000560 mg/kg/day (70% of the cPAD) for the most
highly exposed population subgroup (adults 20-49 years).  The estimated
exposures/risks for food, drinking water and combined food and water are
summarized in Table # 6 for all populations.

Table # 6.  Results of Chronic Dietary Exposure Analysis

Population Subgroup	

cPAD

(mg/kg/day)	

Exposure (mg/kg/day)	

% cPAD

General U.S. Population	0.0008	0.000414	52

All Infants (< 1 year old)	0.0008	0.000122	15

Children 1-2 years old	0.0008	         0.000327	41

Children 3-5 years old	0.0008	0.000342	43

Children 6-12 years old	0.0008	0.000246	31

Youth 13-19 years old	0.0008	0.000253	32

Adults 20-49 years old	0.0008	0.000560	701

Females 13-49 years old	0.0008	0.000304	38

Adults 50+ years old	0.0008	0.000328	41

1The population subgroup with the highest estimated chronic dietary
(food + drinking water) exposure and risk is indicated by bold text.

VII.	Characterization of Inputs/Outputs

The acute dietary exposure and risk estimates are conservative since
they assume that 100% of crops are treated with cymoxanil and that
residues are present at tolerance levels.  In addition, drinking water
exposure estimates were based on screening level estimates generated by
the model.  Dietary exposure estimates could be refined through the use
of anticipated residues and percent crop treated data, as well as
refined estimated drinking water concentrations.  However, since
estimated exposures and risks using conservative assumptions are below
ARIA’s level of concern, such refinement is not warranted.

This chronic dietary exposure for cymoxanil is a partially refined
assessment which incorporates average field trial residues for lettuce,
a screening level % CT data for several registered commodities and
projected % CT for grapes.  Dietary exposure estimates could be further
refined through the use of additional anticipated residues as well as
refined EDWCs. As with the acute assessment, such refinements are not
warranted at this time. 

VIII.	Conclusions

The unrefined acute dietary exposure analysis using DEEM-FCID™
indicates that dietary exposures to cymoxanil from food and drinking
water are below ARIA’s level of concern for this pesticide.  The
estimated acute exposure of females 13-49 years old, the only population
subgroup of concern for acute exposure, represents 72% of the aPAD at
the 95th percentile of exposure.  

The partially refined chronic dietary exposure analysis using
DEEM-FCID™ indicates that dietary exposure to cymoxanil from food and
drinking water are below ARIA’s level of concern for this pesticide.
Estimated chronic dietary exposures are less than or equal to 70% of the
cPAD for the general U.S. population and all population subgroups.

IX.		List of Attachments

Acute Food + Drinking Water Input File

Acute Food + Drinking Water Results File

Chronic Food + Drinking Water Input File

Chronic Food + Drinking Water Results File

Acute Food + Drinking Water Input File

U.S. Environmental Protection Agency                                
Ver. 2.02

DEEM-FCID Acute analysis for CYMOXANIL

Residue file name: E:\Cymoxanil Oct.2006\acute129106.r98

Analysis Date 11-09-2006             Residue file dated:
11-09-2006/09:06:14/8

Reference dose (aRfD) = 0.04 mg/kg bw/day

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

09020210 9B   Balsam pear                        0.050000   1.000  1.000

13010550 13A  Blackberry                         4.000000   1.000  1.000

13010560 13A  Blackberry, juice                  4.000000   1.000  1.000

13010561 13A  Blackberry, juice-babyfood         4.000000   1.000  1.000

13010580 13A  Boysenberry                        4.000000   1.000  1.000

09010750 9A   Cantaloupe                         0.050000   1.000  1.000

09010800 9A   Casaba                             0.050000   1.000  1.000

09020880 9B   Chayote, fruit                     0.050000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.050000   1.000  1.000

09021350 9B   Cucumber                           0.050000   1.000  1.000

13011420 13A  Dewberry                           4.000000   1.000  1.000

08001480 8    Eggplant                           0.200000   1.000  1.000

95001750 O    Grape                              0.100000   1.000  1.000

95001760 O    Grape, juice                       0.100000   1.000  1.000

95001761 O    Grape, juice-babyfood              0.100000   1.000  1.000

95001770 O    Grape, leaves                      0.100000   1.000  1.000

95001780 O    Grape, raisin                      0.100000   1.000  1.000

95001790 O    Grape, wine and sherry             0.100000   1.000  1.000

09011870 9A   Honeydew melon                     0.050000   1.000  1.000

95001880 O    Hop                               31.500000   1.000  1.000

04012040 4A   Lettuce, head                     18.000000   1.000  1.000

13012080 13A  Loganberry                         4.000000   1.000  1.000

95002110 O    Lychee                             1.000000   1.000  1.000

95002120 O    Lychee, dried                      1.000000   1.850  1.000

08002340 8    Okra                               0.200000   1.000  1.000

08002700 8    Pepper, bell                       0.200000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.200000   1.000  1.000

08002710 8    Pepper, bell, dried                0.200000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.200000   1.000  1.000

08002720 8    Pepper, nonbell                    0.200000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.200000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.200000   1.000  1.000

01032960 1C   Potato, chips                      0.050000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500  1.000

01032980 1C   Potato, flour                      0.050000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.050000   1.000  1.000

01032990 1C   Potato, tuber, w/peel              0.050000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000

09023080 9B   Pumpkin                            0.050000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.050000   1.000  1.000

13013200 13A  Raspberry                          4.000000   1.000  1.000

13013201 13A  Raspberry-babyfood                 4.000000   1.000  1.000

13013210 13A  Raspberry, juice                   4.000000   1.000  1.000

13013211 13A  Raspberry, juice-babyfood          4.000000   1.000  1.000

09023560 9B   Squash, summer                     0.050000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.050000   1.000  1.000

09023570 9B   Squash, winter                     0.050000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.050000   1.000  1.000

08003740 8    Tomatillo                          0.200000   1.000  1.000

08003750 8    Tomato                             0.200000   1.000  1.000

08003751 8    Tomato-babyfood                    0.200000   1.000  1.000

08003760 8    Tomato, paste                      0.200000   5.400  1.000

08003761 8    Tomato, paste-babyfood             0.200000   5.400  1.000

08003770 8    Tomato, puree                      0.200000   3.300  1.000

08003771 8    Tomato, puree-babyfood             0.200000   3.300  1.000

08003780 8    Tomato, dried                      0.200000  14.300  1.000

08003781 8    Tomato, dried-babyfood             0.200000  14.300  1.000

08003790 8    Tomato, juice                      0.200000   1.500  1.000

86010000 O    Water, direct, all sources         0.019000   1.000  1.000

86020000 O    Water, indirect, all sources       0.019000   1.000  1.000

09013990 9A   Watermelon                         0.050000   1.000  1.000

09014000 9A   Watermelon, juice                  0.050000   1.000  1.000

Acute Food + Drinking Water Results File

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: acute129106.r98                     Adjustment factor #2
NOT used.

Analysis Date: 11-09-2006/09:24:05    Residue file dated:
11-09-2006/09:06:14/8

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th
Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure  
% aRfD 

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

Females 13-49 yrs:

                    0.028791    71.98    0.051094   127.74    0.108653  
271.63 



Chronic Food + Water Input File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for CYMOXANIL                         
1994-98 data

Residue file: E:\Cymoxanil Oct.2006\chronic129106%CT.R98       Adjust.
#2 used

Analysis Date 11-07-2006             Residue file dated:
11-07-2006/11:14:45/8

Reference dose (RfD) = 0.0008 mg/kg bw/day

Comment:Cymoxanil chronic food + water using mean FT for lettuce; SLUA
%CT for registered uses and 10%CT for Grapes.

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

09020210 9B   Balsam pear                        0.050000   1.000     
1.000   

13010550 13A  Blackberry                         4.000000   1.000     
1.000   

13010560 13A  Blackberry, juice                  4.000000   1.000     
1.000   

13010561 13A  Blackberry, juice-babyfood         4.000000   1.000     
1.000   

13010580 13A  Boysenberry                        4.000000   1.000     
1.000   

09010750 9A   Cantaloupe                         0.050000   1.000     
1.000   

09010800 9A   Casaba                             0.050000   1.000     
1.000   

09020880 9B   Chayote, fruit                     0.050000   1.000     
1.000   

09021020 9B   Chinese waxgourd                   0.050000   1.000     
1.000   

09021350 9B   Cucumber                           0.050000   1.000     
0.100   

13011420 13A  Dewberry                           4.000000   1.000     
1.000   

08001480 8    Eggplant                           0.200000   1.000     
1.000   

95001750 O    Grape                              0.100000   1.000     
0.100   

95001760 O    Grape, juice                       0.100000   1.000     
0.100   

95001761 O    Grape, juice-babyfood              0.100000   1.000     
0.100   

95001770 O    Grape, leaves                      0.100000   1.000     
0.100   

95001780 O    Grape, raisin                      0.100000   1.000     
0.100   

95001790 O    Grape, wine and sherry             0.100000   1.000     
0.100   

09011870 9A   Honeydew melon                     0.050000   1.000     
1.000   

95001880 O    Hop                               31.500000   1.000     
1.000   

04012040 4A   Lettuce, head                      3.150000   1.000     
0.100   

13012080 13A  Loganberry                         4.000000   1.000     
1.000   

95002110 O    Lychee                             1.000000   1.000     
1.000   

95002120 O    Lychee, dried                      1.000000   1.850     
1.000   

08002340 8    Okra                               0.200000   1.000     
1.000   

08002700 8    Pepper, bell                       0.200000   1.000     
0.100   

08002701 8    Pepper, bell-babyfood              0.200000   1.000     
0.100   

08002710 8    Pepper, bell, dried                0.200000   1.000     
0.100   

08002711 8    Pepper, bell, dried-babyfood       0.200000   1.000     
0.100   

08002720 8    Pepper, nonbell                    0.200000   1.000     
0.100   

08002721 8    Pepper, nonbell-babyfood           0.200000   1.000     
0.100   

08002730 8    Pepper, nonbell, dried             0.200000   1.000     
0.100   

01032960 1C   Potato, chips                      0.050000   1.000     
0.100   

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500     
0.100   

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500     
0.100   

01032980 1C   Potato, flour                      0.050000   1.000     
0.100   

01032981 1C   Potato, flour-babyfood             0.050000   1.000     
0.100   

01032990 1C   Potato, tuber, w/peel              0.050000   1.000     
0.100   

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000     
0.100   

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000     
0.100   

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000     
0.100   

09023080 9B   Pumpkin                            0.050000   1.000     
0.010   

09023090 9B   Pumpkin, seed                      0.050000   1.000     
0.010   

13013200 13A  Raspberry                          4.000000   1.000     
1.000   

13013201 13A  Raspberry-babyfood                 4.000000   1.000     
1.000   

13013210 13A  Raspberry, juice                   4.000000   1.000     
1.000   

13013211 13A  Raspberry, juice-babyfood          4.000000   1.000     
1.000   

09023560 9B   Squash, summer                     0.050000   1.000     
0.010   

09023561 9B   Squash, summer-babyfood            0.050000   1.000     
0.010   

09023570 9B   Squash, winter                     0.050000   1.000     
0.010   

09023571 9B   Squash, winter-babyfood            0.050000   1.000     
0.010   

08003740 8    Tomatillo                          0.200000   1.000     
1.000   

08003750 8    Tomato                             0.200000   1.000     
0.100   

08003751 8    Tomato-babyfood                    0.200000   1.000     
0.100   

08003760 8    Tomato, paste                      0.200000   5.400     
0.100   

08003761 8    Tomato, paste-babyfood             0.200000   5.400     
0.100   

08003770 8    Tomato, puree                      0.200000   3.300     
0.100   

08003771 8    Tomato, puree-babyfood             0.200000   3.300     
0.100   

08003780 8    Tomato, dried                      0.200000  14.300     
0.100   

08003781 8    Tomato, dried-babyfood             0.200000  14.300     
0.100   

08003790 8    Tomato, juice                      0.200000   1.500     
0.100   

86010000 O    Water, direct, all sources         0.000100   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.000100   1.000     
1.000   

09013990 9A   Watermelon                         0.050000   1.000     
0.010   

09014000 9A   Watermelon, juice                  0.050000   1.000     
0.010   

Chronic Food + Water Results File

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: E:\Cymoxanil Oct.2006\chronic129106%CT.R98

                                                     Adjustment factor
#2 used.

Analysis Date 11-07-2006/11:15:48     Residue file dated:
11-07-2006/11:14:45/8

Reference dose (RfD, Chronic) = .0008 mg/kg bw/day

COMMENT 1: Cymoxanil chronic food + water using mean FT for lettuce;
SLUA %CT for registered uses and 10%CT for Grapes.

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000414               
51.7%

 

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       45.6%

Northeast region                            0.000366               
45.8%

Midwest region                              0.000451               
56.3%

Southern region                             0.000355               
44.4%

Western region                              0.000509               
63.7%

Hispanics                                   0.000361               
45.1%

Non-hispanic whites                         0.000453               
56.6%

Non-hispanic blacks                         0.000265               
33.2%

Non-hisp/non-white/non-black                0.000323               
40.4%

All infants (< 1 year)                      0.000122               
15.2%

Nursing infants                             0.000080               
10.1%

Non-nursing infants                         0.000137               
17.2%

Children 1-6  yrs                           0.000334               
41.7%

Children 7-12 yrs                           0.000232               
29.0%

Females 13-19 (not preg or nursing)         0.000185               
23.1%

Females 20+ (not preg or nursing)           0.000300               
37.5%

Females 13-50 yrs                           0.000322               
40.3%

Females 13+ (preg/not nursing)              0.000148               
18.6%

Females 13+ (nursing)                       0.000226               
28.2%

Males 13-19 yrs                             0.000320               
40.0%

Males 20+ yrs                               0.000670               
83.8%

Seniors 55+                                 0.000288               
36.0%

Children 1-2 yrs                            0.000327               
40.8%

Children 3-5 yrs                            0.000342               
42.8%

Children 6-12 yrs                           0.000246               
30.7%

Youth 13-19 yrs                             0.000253               
31.7%

Adults 20-49 yrs                            0.000560               
70.0%

Adults 50+ yrs                              0.000328               
41.0%

Females 13-49 yrs                           0.000304               
38.0%

Cymoxanil                       Dietary Exposure Assessment             
           DP Num: 333189	                PC Code: 129106               
                                  	

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