Document ID: EPA-HQ-OPP-2009-0801-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-07-14T04:00Z

SEQ CHAPTER \h \r 1 

     

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

                                                                        
                                                                        
                                            

                                                                        
                                                                        
        			      

	OFFICE OF     

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM        

DATE:  	March 8, 2010 

SUBJECT:	Cyazofamid: Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessments for Tolerance Petition and
Proposed Section 3 Amendment Registration for Uses on Brassica (Cole)
Leafy Vegetables Crop Group 5, Turnip Greens, Spinach, and Hops.

PC Code:  085651

DP Barcode:  371163

Decision No.:  420982

Registration No.:  71512-2 , 71512-3

Petition No.:  9E7615

Regulatory Action:  Sec. 3 Registration

Risk Assessment Type:  NA

Case No.:  NA

TXR No.:  NA

CAS No.:  120116-88-3

MRID No.:  

40 CFR:  180.601

REVIEWER:	Amelia M. Acierto, Chemist

Risk Assessment Branch 3

Health Effects Division (7509P)

THROUGH:	

		Mohsen Sahafeyan, Chemist

Thurston Morton, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

		Stephen Funk, Senior Science Advisor

		Risk Assessment Branch III

Health Effects Division (7509P)

 

TO:		Nancy Tsaur, Risk Assessor

Risk Assessment Branch III

Health Effects Division (7509P)

and

		Barbara Madden, RM #5

		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.  Dietary risk
assessments were performed to support a FIFRA Section 3 request to amend
the registration of the fungicide cyazofamid for use on Brassica (Cole)
leafy vegetables crop group 5, turnip greens, spinach, and hops. 

Acute and chronic dietary (drinking water) risk assessment for
cyazofamid have been conducted previously for turf and ornamentals
(D332427, Susan L. Stanton, 9/14/06).  The risk estimate considered
drinking water exposure only.  Subsequent dietary risk assessments were
performed to support separate FIFRA Section 3 requests on carrots
(D381623, A.M.Acierto, 3/5/2008) and on fruiting vegetables, okra, and
grapes (D357043, Amelia M. Acierto 3/25/09).  Dietary risk estimates
were determined considering exposures from food plus drinking water
using the upper-bound estimated drinking water concentrations (EDWCs)
for cyazofamid in surface water sources for turf grass provided by the
Environmental Fate and Effects Division (EFED).  This decision was based
on EFED’s determination that the highest use rate per application per
season is on turf grass as compared with the use rates on various food
crops (D342613, Mohammed A. Ruhman, 2/21/08 and D356836, Jose L.
Melendez, 3/24/09).  Additional runs to cover the new crops (Brassica
(Cole) leafy vegetables crop group 5, turnip greens, spinach, and hops)
were performed by EFED with the same result that the highest EDWCs of
all crops (past and present) were obtained for turf and ornamentals
(surface waters) and ornamentals (ground water) (D370673, Jose L.
Melendez, 3/1/2010).  As in the earlier dietary assessments, HED used
the highest calculated screening EDWCs for surface water based on the
3rd modeling scenario: 136 ppb for the acute analysis and 133 ppb for
the chronic analysis.  As noted previously, this approach may
significantly overestimate dietary exposure to cyazofamid from drinking
water; however, since estimated aggregate food and drinking water
exposures using this approach are well below the acute and chronic
levels of concern, additional refinements were not deemed necessary. 
For both the acute and chronic analyses, the drinking water EDWC was
incorporated directly as a point estimate in the DEEM analysis to assess
exposure to cyazofamid from drinking water.  Drinking water was
incorporated directly into the DEEM-FCID into the food categories
“water, direct, all sources” and water, indirect, all sources.  

The acute dietary (food plus drinking water) analysis was performed for
females 13-49 years old only since an acute endpoint of concern was not
identified for the general U.S. population.  The chronic dietary
analyses were performed for the general U.S. population and all the
population subgroups.  HED is concerned when estimated dietary risks
exceed 100% of the acute or chronic population adjusted dose (aPAD and
cPAD). 

  

The acute and chronic analyses assumed that cyazofamid residues are
present in all registered food commodities at tolerance levels and that
100% of all commodities are assumed treated.  Processing factors for all
registered or proposed crops were set to 1, based on the results of
processing studies demonstrating that residues of cyazofamid in
processed commodities would not exceed the raw agricultural commodity
(RAC) tolerances.

Acute Dietary Exposure Results

The unrefined acute dietary (food + water) 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 well below HED’s level of concern at the 95th percentile
of exposure.  Combined dietary exposure from food and drinking water is
estimated at 0.012139 mg/kg/day, equivalent to 1.2% of the acute
Population Adjusted Dose (aPAD).  

Chronic Dietary Exposure Results

Chronic dietary exposure estimates for food and drinking water combined
are also well below HED’s level of concern.  Using the DEEM-FCID
software, dietary exposure for the general U.S. population is estimated
at 0.004945 mg/kg/day, equivalent to <1% of the chronic Population
Adjusted Dose (cPAD) and 0.011079 mg/kg/day, equivalent to 1.2% of the
cPAD for infants <1 year old, the population subgroup with the highest
estimated chronic dietary exposure to cyazofamid.  

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 cyazofamid (D357043,
Amelia M. Acierto, 3/25/09) was conducted to support the FIFRA §3
registration on fruiting vegetables, okra and grapes.  As in the 2009
dietary assessment, this current assessment incorporates drinking water
directly into the dietary analyses.

II.	Food Residue Information

Residues of Concern:  The HED Metabolism Assessment Review Committee
(MARC) concluded in a meeting on 2/18/04 that for the risk assessment
and tolerance expression, parent and the metabolite designated as CCIM
are the residues of concern for plant commodities.  The MARC also
concluded that cyazofamid and the metabolites designated as CCIM,
CCIM-AM and CTCA are considered to be the major residues in water and
should be included in the drinking water risk assessment.  The current
uses of cyazofamid fall under 40 CFR §180.6(a)(3) (i.e., there is no
reasonable expectation of finite residues in livestock commodities).  

Tolerances:  Tolerances have been established under 40 CFR §180.601 for
the combined residues of  cyazofamid and its metabolite CCIM
[4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile] in or on
cucurbit vegetables, Group 9 (0.1 ppm); vegetable, fruiting, group 8
(0.40 ppm);  potato (0.02 ppm); okra (0.40 ppm), carrot, roots (0.09
ppm) and grapes (1.5 ppm). Turf and ornamentals (non-food use sites) did
not require establishment of additional tolerances.

Residue Data used for the Acute and Chronic Assessments:  The unrefined
acute and chronic analyses assumed that cyazofamid residues are present
in/on all registered food commodities at tolerance levels and assumed
100% of all commodities are treated.  There are no processing data for
brassica (Cole) leafy vegetables crop group 5, turnip greens, spinach,
and hops.  The tolerance summary for cyazofamid used in the acute and
chronic analyses for the proposed new uses are summarized below in Table
1.  A complete listing of the residues used in the analyses are included
in Attachments 1, and 3.

Table 1.  Tolerance Summary for Cyazofamid Proposed Uses on Brassica
Cole Leafy Vegetables Crop Group 5, Turnip Greens, Spinach and Hops.

Commodity	ProposedTolerance (ppm)	Recommended Tolerances (ppm)
Tolerances Proposed under 40 CFR§180.601

Brassica Head and Stem Subgroup 5A 	1.2	1.2	1.2

Brassica Leafy Greens Subgroup 5B	12.0	12.0	12.0

Turnip greens	12.0	12.0	12.0

Spinach	9.0	9.0	9.0

Hops	10.0	10.0	10.0

 Drinking Water Data

Reference: Estimated Drinking Water Concentrations of Parent Cyazofamid
and its Degradates of Concern CCIM, CCIM-AM and CTCA, for Use in Human
Health Risk Assessment: New Uses on Brassica (Cole) Leafy Vegetables &
Turnip Greens (Crop Group 5), Spinach, and Hops; Jose L. Melendez,
D370673, March 1, 2010.

The above memorandum from EFED is a drinking waters assessment (DWA)
that presents the EDWCs for parent cyazofamid, and the degradates CCIM,
CCIM-AM and CTCA for use in an FQPA human health risk assessment.
Cyazofamid fungicide and/or its degradates may reach both surface and
groundwater under some conditions.  The degradates’ EDWCs were modeled
individually (as opposed to the use of the total residue approach). 
This was done because sufficient data were available on the degradates
to model them individually (although some assumptions were made, see
below).  It is noted that DWAs were previously issued as follows:

Summary of Cyazofamid Drinking Water Exposure Assessments

Date	DP Barcode	Uses included

4/28/04	301099	Cucurbits, potatoes and tomatoes

9/6/06	319466	Turf and Ornamentals

3/5/08	342613	Carrots

3/24/09	356836	Fruiting vegetables + okra, and grapes (East of the Rocky
mountains)

This DWA builds largely upon the previous assessments.  Additional runs
were performed to cover the new crops; the highest EDWCs of all crops
(past and present) were obtained for turf and ornamentals (surface
waters) and ornamentals (ground water).  The screening-level surface
water and ground water EDWCs were obtained using the tier 2 linked
aquatic models PRZM/ EXAMS and the tier 1 aquatic model SCI-GROW,
respectively.  EDWCs are summarized in Table 2 for three scenarios as
follows:

1st scenario: the parent is applied at the maximum rate;

2nd scenario: the degradates CCIM and CCIM-AM (and CTCA) are applied at
the parent-molar equivalent amounts, spreading the application rate
through the degradates, according to the molecular ratios and the
adjusted maximum percentages of the degradates observed in the
environmental fate studies; and

3rd scenario: the terminal degradate, CTCA, is applied assuming
application of 100% molar conversion of the parent to the degradate.

Based on the results presented in Table 2 below and a time-line of
exposure, the surface water acute EDWC is 38.2 ppb (equal to the Parent
“14.362 ppb” + CCIM “17.106 ppb” + CCIM-AM “6.699 ppb”). 
CTCA is not included in the surface water acute EDWC because it is not
expected to be present in this time frame. The surface water non-cancer
chronic is 133.5 ppb and the cancer chronic is 77.3 ppb (equal to the
value for the terminal degradate, CTCA). For ground water, the EDWC is
2.18 ppb, which is suitable for acute and chronic exposures (equal to
the value for the terminal degradate, CTCA).

Table 2. Maxima of surface and ground water EDWCs for cyazofamid and its
relevant major degradates.  Turf and ornamentals use pattern, previously
reported in D319466 (dated 9/6/06).

Scenario	Chemical	Surface water EDWCs (ppb)	Ground water EDWC (ppb)

Acute	Chronic “Non-Cancer”	Chronic “Cancer”

	1st  Scenario	Cyazofamid	14.362	0.377	0.279	0.01180

2nd  Scenario	CCIM	17.106	12.094	10.600	0.00061

	CCIM-AM	6.699	6.312	3.611	0.00270

3rd  Scenario 	CTCA	136.242	133.458	77.270	2.180

                           EDWCs	38.2	133.5	77.3	2.18

The above stated values represent upper-bound estimates of the parent,
individual degradates and/or terminal degradate concentrations that
might be found in surface water and groundwater due to the use of
cyazofamid on turf and ornamentals.  EFED emphasizes that this is a
screening level analysis and additional refinements could be made if
needed.

Typically, HED uses the higher of the surface or groundwater estimates
for each duration when assessing dietary risk.  Therefore, although CTCA
is not expected to be found in the acute time frame of exposure, HED
will continue to use the EDWC which includes CTCA (136 ppb). This
approach may significantly overestimate dietary exposure to cyazofamid
from drinking water, however, since estimated aggregate food and
drinking water exposures using this approach are well below the acute
and chronic levels of concern, additional refinements were not deemed
necessary. 

   

M-FCID™ Program and Consumption Information

Cyazofamid 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.

V.	Toxicological Information

The toxicology database for cyazofamid with regard to the acute and
chronic reference doses (RfDs) remain unchanged.  The rationale for
toxicity endpoint selection was discussed in detail in the most recent
human health risk assessment document (D356837, N. Tsaur, 5/5/20009) and
will not be repeated here.  However, the doses and toxicological
endpoints selected for dietary risk assessments are summarized in Table
3.  

.

Table 3.  Summary of Cyazofamid Toxicological Doses and Endpoints for
Dietary Risk Assessment.

Exposure

Scenario	

Dose Used in Risk Assessment, UF 	

FQPA SF and Level of Concern for Risk Assessment	

Study and Toxicological Effects

Acute Dietary

(Females 13-49 years of age)	

NOAEL = 100 mg/kg

UF = 100

Acute RfD = 1.0 mg/kg	

FQPA SF = 1X

aPAD = acute RfD

              FQPA SF

= 1.0 mg/kg	

Rat Prenatal Developmental Toxicity (MRID 45408933)

LOAEL = 1,000 mg/kg based on developmental toxicity findings of
increased incidence of bent 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	

No adverse effects were observed which could be attributed to a
single-dose exposure.

Chronic Dietary

(All populations)	

NOAEL= 94.8 mg/kg/day

UF = 100

Chronic RfD = 0.95

 mg/kg/day	

FQPA SF = 1X

cPAD = chronic RfD

               FQPA SF

= 0.95 mg/kg/day	

18-Month Mouse Oral Carcinogenicity (MRID 45408932)

LOAEL = 985 mg/kg/day based on increased skin lesions.

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

VI.	Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned
when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses
estimate the dietary exposure of the U.S. population and various
population subgroups.  The acute exposure results are reported in Tables
4 for females 13-49 only.  The chronic results reported in 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.  

Results of Acute Dietary Exposure Analysis

The Tier 1 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 well below HED’s level of
concern (i.e., <100% of the aPAD of 1.0 mg/kg).  The combined dietary
exposure from food and drinking water is estimated at 0.012139 mg/kg/day
(equivalent to 1.2% of the aPAD), at the 95th percentile of exposure,
the appropriate regulatory statistic for Tier 1 dietary assessments as
shown in Table 4.   

Table 4.  Results of Acute Dietary Exposure Analysis for Food and
Drinking Water at the 95th Percentile of Exposure 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 	1	0.012139	1.2	0.024480	2.45	0.059739	5.97

  

Results of Chronic Dietary Exposure Analysis

-FCID™ software are well below HED’s level of concern for the
general U.S. population and each of the population subgroups.  Dietary
exposure was estimated at 0.004945 mg/kg/day for the U.S. population
(<1% of the cPAD) and 0.011079 mg/kg/day (1.2% of the cPAD) for the most
highly exposed population subgroup (infants <1 year old).  The estimated
exposures/risks for food and drinking water are summarized in Table 5
for all populations.

Table 5.  Results of Chronic Dietary Exposure Analysis for Food and
Drinking Water

Population Subgroup	    Exposure

(mg/kg/day)	% cPAD

General U.S. Population	0.004945	<1

All Infants (< 1 year old)1	0.011079	1.2

Children 1-2 years old	0.010749	1

Children 3-5 years old	0.008556	<1

Children 6-12 years old	0.004916	<1

Youth 13-19 years old	0.003393	<1

Adults 20-49 years old	0.004351	<1

Adults 50+ years old	0.004884	<1

Females 13-49 years old	0.004302	<1

 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

These acute and chronic dietary exposure and risk estimates are
conservative since they assume that 100% of crops are treated with
cyazofamid and that residues are present at tolerance levels.  In
addition, drinking water exposure estimates were based on screening
level estimates generated by the PRZM-EXAMS 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 well below HED’s level of concern, such
refinement is not warranted.

VIII.	Conclusions

These unrefined, Tier 1 dietary exposure analyses using DEEM-FCID™
indicate that acute and chronic dietary exposures to cyazofamid from
food and drinking water are well below HED’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 1.2%
of the aPAD at the 95th percentile of exposure.  Estimated chronic
dietary exposures are less than or equal to 1.2% 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

Chronic Food + Drinking Water Input File

U.S. Environmental Protection Agency                           Ver. 2.00

DEEM-FCID Chronic analysis for CYAZOFAMID                    1994-98
data

Residue file: C:\Documents and Settings\aacierto\Desktop\DEEM-FCID
Files\DEEM2010\Chronic cyazofamid food+water.R98     Adjust. #2 NOT used
                     

Analysis Date 03-16-2010        Residue file dated:
03-16-2010/13:48:52/8

Reference dose (RfD) = 0.95  (NOEL) = 94.8 mg/kg bw/day

Comment:Drinking Water using CTCA Drinking Water estimate (scenario #3)

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

09020210 9B   Balsam pear                        0.100000   1.000     
1.000   

05010610 5A   Broccoli                           1.200000   1.000     
1.000   

05010611 5A   Broccoli-babyfood                  1.200000   1.000     
1.000   

05010620 5A   Broccoli, Chinese                  1.200000   1.000     
1.000   

05020630 5B   Broccoli raab                     12.000000   1.000     
1.000   

05010640 5A   Brussels sprouts                   1.200000   1.000     
1.000   

05010690 5A   Cabbage                            1.200000   1.000     
1.000   

05020700 5B   Cabbage, Chinese, bok choy        12.000000   1.000     
1.000   

05010710 5A   Cabbage, Chinese, napa             1.200000   1.000     
1.000   

05010720 5A   Cabbage, Chinese, mustard          1.200000   1.000     
1.000   

09010750 9A   Cantaloupe                         0.100000   1.000     
1.000   

01010780 1AB  Carrot                             0.090000   1.000     
1.000   

01010781 1AB  Carrot-babyfood                    0.090000   1.000     
1.000   

09010800 9A   Casaba                             0.100000   1.000     
1.000   

05010830 5A   Cauliflower                        1.200000   1.000     
1.000   

09020880 9B   Chayote, fruit                     0.100000   1.000     
1.000   

09021020 9B   Chinese waxgourd                   0.100000   1.000     
1.000   

05021170 5B   Collards                          12.000000   1.000     
1.000   

09021350 9B   Cucumber                           0.100000   1.000     
1.000   

95001750 O    Grape                              1.500000   1.000     
1.000   

95001760 O    Grape, juice                       1.500000   1.000     
1.000   

95001761 O    Grape, juice-babyfood              1.500000   1.000     
1.000   

95001770 O    Grape, leaves                      1.500000   1.000     
1.000   

95001780 O    Grape, raisin                      1.500000   1.000     
1.000   

95001790 O    Grape, wine and sherry             1.500000   1.000     
1.000   

09011870 9A   Honeydew melon                     0.100000   1.000     
1.000   

95001880 O    Hop                               10.000000   1.000     
1.000   

05021940 5B   Kale                              12.000000   1.000     
1.000   

05011960 5A   Kohlrabi                           1.200000   1.000     
1.000   

05022290 5B   Mustard greens                    12.000000   1.000     
1.000   

08002340 8    Okra                               0.400000   1.000     
1.000   

08002700 8    Pepper, bell                       0.400000   1.000     
1.000   

08002701 8    Pepper, bell-babyfood              0.400000   1.000     
1.000   

08002710 8    Pepper, bell, dried                0.400000   1.000     
1.000   

08002711 8    Pepper, bell, dried-babyfood       0.400000   1.000     
1.000   

08002720 8    Pepper, nonbell                    0.400000   1.000     
1.000   

08002721 8    Pepper, nonbell-babyfood           0.400000   1.000     
1.000   

08002730 8    Pepper, nonbell, dried             0.400000   1.000     
1.000   

01032960 1C   Potato, chips                      0.020000   1.000     
1.000   

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

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

01032980 1C   Potato, flour                      0.020000   1.000     
1.000   

01032981 1C   Potato, flour-babyfood             0.020000   1.000     
1.000   

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

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

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

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

09023080 9B   Pumpkin                            0.100000   1.000     
1.000   

09023090 9B   Pumpkin, seed                      0.100000   1.000     
1.000   

05023180 5B   Rape greens                       12.000000   1.000     
1.000   

04013550 4A   Spinach                            9.000000   1.000     
1.000   

09023560 9B   Squash, summer                     0.100000   1.000     
1.000   

09023561 9B   Squash, summer-babyfood            0.100000   1.000     
1.000   

09023570 9B   Squash, winter                     0.100000   1.000     
1.000   

09023571 9B   Squash, winter-babyfood            0.100000   1.000     
1.000   

08003740 8    Tomatillo                          0.400000   1.000     
1.000   

08003750 8    Tomato                             0.400000   1.000     
1.000   

08003751 8    Tomato-babyfood                    0.400000   1.000     
1.000   

08003760 8    Tomato, paste                      0.400000   1.000     
1.000   

08003761 8    Tomato, paste-babyfood             0.400000   1.000     
1.000   

08003770 8    Tomato, puree                      0.400000   1.000     
1.000   

08003771 8    Tomato, puree-babyfood             0.400000   1.000     
1.000   

08003780 8    Tomato, dried                      0.400000   1.000     
1.000   

08003781 8    Tomato, dried-babyfood             0.400000   1.000     
1.000   

08003790 8    Tomato, juice                      0.400000   1.000     
1.000   

95003800 O    Tomato, Tree                       0.200000   1.000     
1.000   

05023890 5B   Turnip, greens                    12.000000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.133000   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.133000   1.000     
1.000   

09013990 9A   Watermelon                         0.100000   1.000     
1.000   

09014000 9A   Watermelon, juice                  0.100000   1.000     
1.000   

Chronic Food + Drinking Water Results File

U.S. Environmental Protection Agency                                Ver.
2.00

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

Residue file name: C:\Documents and Settings\aacierto\Desktop\DEEM-FCID
Files\DEEM2010\Chronic cyazofamid food+water.R98

                                             Adjustment factor #2 NOT
used.

Analysis Date 03-16-2010/13:52:31  Residue file dated:
03-16-2010/13:48:52/8

Reference dose (RfD, Chronic) = .95 mg/kg bw/day

NOEL (Chronic) = 94.8 mg/kg bw/day

COMMENT 1: Drinking Water using CTCA Drinking Water estimate (scenario
#3)

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of  
Percent 

           Subgroup                       body wt/day   Exposure 1/  of
RfD 

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

U.S. Population (total)                     0.004945       19,170       
0.5%

U.S. Population (spring season)             0.004835       19,607       
0.5%

U.S. Population (summer season)             0.005231       18,123       
0.6%

U.S. Population (autumn season)             0.004869       19,469       
0.5%

U.S. Population (winter season)             0.004838       19,595       
0.5%

Northeast region                            0.004930       19,231       
0.5%

Midwest region                              0.004722       20,075       
0.5%

Southern region                             0.004802       19,743       
0.5%

Western region                              0.005426       17,470       
0.6%

Hispanics                                   0.004836       19,603       
0.5%

Non-hispanic whites                         0.004649       20,390       
0.5%

Non-hispanic blacks                         0.006007       15,781       
0.6%

Non-hisp/non-white/non-black                0.007056       13,436       
0.7%

All infants (< 1 year)                      0.011079        8,557       
1.2%

Nursing infants                             0.004345       21,817       
0.5%

Non-nursing infants                         0.013634        6,953       
1.4%

Children 1-6  yrs                           0.008929       10,617       
0.9%

Children 7-12 yrs                           0.004649       20,394       
0.5%

Females 13-19 (not preg or nursing)         0.003240       29,256       
0.3%

Females 20+ (not preg or nursing)           0.004777       19,844       
0.5%

Females 13-50 yrs                           0.004422       21,440       
0.5%

Females 13+ (preg/not nursing)              0.003590       26,403       
0.4%

Females 13+ (nursing)                       0.005594       16,945       
0.6%

Males 13-19 yrs                             0.003526       26,884       
0.4%

Males 20+ yrs                               0.004303       22,034       
0.5%

Seniors 55+                                 0.004900       19,347       
0.5%

Children 1-2 yrs                            0.010749        8,819       
1.1%

Children 3-5 yrs                            0.008556       11,081       
0.9%

Children 6-12 yrs                           0.004916       19,283       
0.5%

Youth 13-19 yrs                             0.003393       27,936       
0.4%

Adults 20-49 yrs                            0.004351       21,789       
0.5%

Adults 50+ yrs                              0.004884       19,411       
0.5%

Females 13-49 yrs                           0.004302       22,034       
0.5%

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

Acute Food + Drinking Water Input File

	

U.S. Environmental Protection Agency                           Ver. 2.02

DEEM-FCID Acute analysis for CYAZOFAMID

Residue file name: C:\Documents and Settings\aacierto\Desktop\DEEM-FCID
Files\DEEM2010\acute cyazofamid food+water.R98

Analysis Date 03-16-2010        Residue file dated:
03-16-2010/13:34:40/8

Reference dose: aRfD = 1 mg/kg bw/day  NOEL = 100 mg/kg bw/day

Comment: Drinking Water using CTCA Drinking Water estimate (scenario #3)

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

09020210 9B   Balsam pear                        0.100000   1.000  1.000

05010610 5A   Broccoli                           1.200000   1.000  1.000

05010611 5A   Broccoli-babyfood                  1.200000   1.000  1.000

05010620 5A   Broccoli, Chinese                  1.200000   1.000  1.000

05020630 5B   Broccoli raab                     12.000000   1.000  1.000

05010640 5A   Brussels sprouts                   1.200000   1.000  1.000

05010690 5A   Cabbage                            1.200000   1.000  1.000

05020700 5B   Cabbage, Chinese, bok choy        12.000000   1.000  1.000

05010710 5A   Cabbage, Chinese, napa             1.200000   1.000  1.000

05010720 5A   Cabbage, Chinese, mustard          1.200000   1.000  1.000

09010750 9A   Cantaloupe                         0.100000   1.000  1.000

01010780 1AB  Carrot                             0.090000   1.000  1.000

01010781 1AB  Carrot-babyfood                    0.090000   1.000  1.000

09010800 9A   Casaba                             0.100000   1.000  1.000

05010830 5A   Cauliflower                        1.200000   1.000  1.000

09020880 9B   Chayote, fruit                     0.100000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.100000   1.000  1.000

05021170 5B   Collards                          12.000000   1.000  1.000

09021350 9B   Cucumber                           0.100000   1.000  1.000

08001480 8    Eggplant                           0.400000   1.000  1.000

95001750 O    Grape                              1.500000   1.000  1.000

95001760 O    Grape, juice                       1.500000   1.000  1.000

95001761 O    Grape, juice-babyfood              1.500000   1.000  1.000

95001770 O    Grape, leaves                      1.500000   1.000  1.000

95001780 O    Grape, raisin                      1.500000   1.000  1.000

95001790 O    Grape, wine and sherry             1.500000   1.000  1.000

09011870 9A   Honeydew melon                     0.100000   1.000  1.000

95001880 O    Hop                               10.000000   1.000  1.000

05021940 5B   Kale                              12.000000   1.000  1.000

05011960 5A   Kohlrabi                           1.200000   1.000  1.000

05022290 5B   Mustard greens                    12.000000   1.000  1.000

08002340 8    Okra                               0.400000   1.000  1.000

08002700 8    Pepper, bell                       0.400000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.400000   1.000  1.000

08002710 8    Pepper, bell, dried                0.400000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.400000   1.000  1.000

08002720 8    Pepper, nonbell                    0.400000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.400000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.400000   1.000  1.000

01032960 1C   Potato, chips                      0.020000   1.000  1.000

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

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

01032980 1C   Potato, flour                      0.020000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.020000   1.000  1.000

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

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

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

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

09023080 9B   Pumpkin                            0.100000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.100000   1.000  1.000

05023180 5B   Rape greens                       12.000000   1.000  1.000

04013550 4A   Spinach                            9.000000   1.000  1.000

09023560 9B   Squash, summer                     0.100000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.100000   1.000  1.000

09023570 9B   Squash, winter                     0.100000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.100000   1.000  1.000

08003740 8    Tomatillo                          0.400000   1.000  1.000

08003750 8    Tomato                             0.400000   1.000  1.000

08003751 8    Tomato-babyfood                    0.400000   1.000  1.000

08003760 8    Tomato, paste                      0.400000   1.000  1.000

08003761 8    Tomato, paste-babyfood             0.400000   1.000  1.000

08003770 8    Tomato, puree                      0.400000   1.000  1.000

08003771 8    Tomato, puree-babyfood             0.400000   1.000  1.000

08003780 8    Tomato, dried                      0.400000   1.000  1.000

08003781 8    Tomato, dried-babyfood             0.400000   1.000  1.000

08003790 8    Tomato, juice                      0.400000  
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86020000 O    Water, indirect, all sources       0.136000   1.000  1.000

09013990 9A   Watermelon                         0.100000   1.000  1.000

09014000 9A   Watermelon, juice                  0.100000   1.000  1.000

Acute Food + Drinking Water Results File

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: acute cyazofamid food+water.R98 Adjustment factor #2 NOT
used.

Analysis Date: 03-16-2010/13:37:03  Residue file dated:
03-16-2010/13:34:40/8

NOEL (Acute) = 100.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment:"Drinking Water using CTCA Drinking Water estimate (scenario
#3)"

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

Summary calculations (per capita):

      95th Percentile          99th Percentile           99.9th
Percentile

 Exposure  % aRfD   MOE     Exposure  % aRfD    MOE   Exposure  % aRfD 
MOE  

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

U.S. Population:

0.014299    1.43    6993   0.031974    3.20    3127   0.071845   7.18  
1391    

Females 13-49 yrs:

0.012139    1.21    8237   0.024480    2.45    4085   0.059739   5.97  
1673  

Cyazofamid	Dietary Exposure and Risk Assessment	DP Number: 371163

PC Code:  085651		                				  
________________________________________________________________________
______________

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