Document ID: EPA-HQ-OPP-2008-0731-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-07-08T04:00Z

SEQ CHAPTER \h \r 1 

     

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

                                                                        
                                                                        
                                            

                                                                        
                                                                        
        			      OFFICE OF     

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	March 25, 2009 

SUBJECT:	Cyazofamid: Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessments for an IR-4 Proposed
Section 3 Registration Amendment to Add Uses in/on Fruiting Vegetables,
Okra, and Grapes. 

PC Code:  085651

DP Barcode:  357043

Decision No.:  399610

Registration No.:  71512-3

Petition No.:  8E7427

Regulatory Action:  Sec. 3 Registration

Risk Assessment Type:  NA

Case No.:  NA

TXR No.:  NA

CAS No.:  120116-88-3

MRID No.:  47528401, 47528402

40 CFR:  180.601

REVIEWER:	Amelia M. Acierto, Chemist

Risk Assessment Branch 3

Health Effects Division (7509P)

THROUGH:	William Cutchin, Chemist

Sheila Piper, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

Leung Cheng, Senior Chemist

Risk Assessment Branch 3

Health Effects Division (7509P)

TO:		Nancy Tsaur, Risk Assessor

Risk Assessment Branch 3

Health Effects Division (7509P)

and

		Barbara Madden, RM #5

		Risk Integration, Minor Use, and Emergency Response Branch

Registration Division (7505P)



Executive Summary

Acute (females 13-49 years old only) and chronic dietary risk
assessments were 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.  The analyses were
performed to support the proposed amendment of a FIFRA §3 registration
of the fungicide, cyazofamid, to add uses in/on the rest of the fruiting
vegetables and grapes. 

Acute and chronic dietary risk assessments have been conducted
previously for turf and ornamentals (D332427, Susan L. Stanton, 9/14/06)
and for carrot root (D343442, Amelia M. Acierto, 3/5/08).  For the
purpose of the new use pattern, HED has concluded that it would not be
necessary to amend the dietary risk assessment for carrots except for
amending the tolerance for tomato from 0.2 ppm to 0.4 ppm and adding the
rest of the fruiting vegetables, crop group 8 and okra into the residue
file.  This decision is based on the determination by the Environmental
Fate and Effects Division (EFED) that the maximum estimated Drinking
Water Concentration (EDWCs) for parent cyazofamid and degradates CCIM,
CCIM-AM and CTCA for the fruiting vegetables, okra, and grapes use
pattern in comparison to turf and ornamental use pattern, are much lower
as values are 11% for the surface water acute, 2.6% for the surface
water non-cancer chronic, and 3.5% for the cancer chronic. (D356836,
Jose L. Melendez, 3/24/2009).

Therefore, the dietary risk assessment on fruiting vegetables and grapes
will be conducted using the same information and parameters used for the
dietary risk assessment on carrot root.  

 

The unrefined, Tier 1 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.  All
processing factors 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.

Drinking water was incorporated directly into the dietary assessment
using the estimated drinking water concentrations (EDWC) for the
terminal degradate (CTCA) in surface water.  EDWCs were generated using
the PRZM-EXAMS models.  For the acute assessment, the 1-in-10 year
annual peak concentration of 136 ppb was used; for the chronic
assessment, the 1-in-10 year annual mean value of 133 ppb was used.

Acute Dietary Exposure Results

The Tier 1 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
well below HED’s level of concern at the 95th percentile of exposure. 
Combined dietary exposure from food and drinking water is estimated at
0.009409 mg/kg/day, equivalent to <1% 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 is estimated at 0.003984 mg/kg/day for the
general U.S. population (<1% of the chronic Population Adjusted Dose
(cPAD) and 0.010761 mg/kg/day (1.1% 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 (D343442,
Amelia M. Acierto, 3/5/08) was conducted to support the FIFRA §3
registration on carrot, roots.  As in the assessment for carrot, root,
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), imported wine grapes (1.5 ppm),
potato (0.02 ppm) and tomato (0.2 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,
Tier 1 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.  Adequate processing data
are available for grapes (MRID 45409028), potatoes (MRID 45409033) and
tomatoes (MRID 45409031).  The results of these studies indicate that
residues in processed commodities will not exceed the raw agricultural
commodity (RAC) tolerances (A. Acierto, 

D285680, 2/20/04).  Therefore, all processing factors were set to 1x.  
There were no processing data for carrot. The food residue data used in
the acute and chronic analyses are summarized below in Table 1.

Table 1.  Residue Data used in the Acute and Chronic Dietary Analyses
for Cyazofamid

Commodity	Tolerance (ppm)	Percent Crop Treated	Processing Factors

Fruiting vegetables, crop group 8	0.4 	100	1

Okra	0.4	100	1

Grape	1.5	100	1

 Drinking Water Data

Reference: Estimated Drinking Water Concentrations of Parent Cyazofamid
and its Degradates CCIM, CCIM-AM and CTCA for Use in Human Health Risk
Assessment (Use on Fruiting Vegetables, Crop Group 8 + Okra, and Grapes,
East of the Rocky Mountains); Jose L. Melendez, D356836, 3/24/09.

The Environmental Effects Division (EFED) determined that the maximum
estimated Drinking Water Concentration (EDWCs) for parent cyazofamid and
degradates CCIM, CCIM-AM and CTCA for the fruiting vegetables, Crop
Group 8 + okra, and grapes use pattern in comparison to turf and
ornamental use pattern, are much lower as values are 11% for the surface
water acute, 2.3% for the surface water non-cancer chronic, and 3.5% for
the cancer chronic (DP Number 356836, Jose L. Melendez, 3/24/09.). 
Therefore the EDWCs from EFED’s previous drinking water assessment for
turf and ornamentals, which was used for carrots, were used in this
dietary assessment as described below.

The Environmental Fate and Effects Division (EFED) calculated screening
level surface water and ground water estimates for cyazofamid and its
degradates using linked PRZM/EXAMS models 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/ .  Estimated drinking water
concentrations (EDWCs) are presented in Table 2 for three scenarios as
follows:

(1) 1st scenario (parent) assuming application of the maximum rate as
parent;

(2) 2nd scenario (each of the degradates CCIM, CCIM-AM, and CTCA)
assuming application of the molar equivalent of the parent for each of
the degradate by apportioning the rate between the degradates based on
molecular ratios and adjusted maximums found in fate studies; and

(3) 3rd scenario (the terminal degradate CTCA) assuming application of
100% molar conversions of the parent into this terminal degradate CTCA.

Table 2.  Resulting Maximum Surface/Ground water EDWCs for cyazofamid
and each of its Major Degradates

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

Acute

(1-in-10 yr. peak)	Chronic

 (1-in-10 yr. mean)

	1st  Scenario	Parent	14.362	0.377	0.01180

2nd  Scenario 	CCIM	17.106	12.094	0.00061

	CCIM-AM	6.699	6.312	0.00270

	CTCA	16.716	11.993	0.52300

3rd  Scenario 	CTCA	136.242	133.458	2.18000

The highest acute (peak) and chronic (mean) EDWCs were estimated for
surface water using the PRZM/EXAMS model.  For the purpose of this Tier
1 dietary assessment, 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.  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.

  

IV.	DEEM-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

On February 10, 2004, the HIARC evaluated the toxicology database for
cyazofamid with regard to the acute and chronic reference doses (RfDs). 
The doses and toxicological endpoints selected for dietary exposure
scenarios 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 

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 0.009409 mg/kg/day
(equivalent to <1% 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	0.009409	<1	0.015596	1.56	0.022290	2.23

Results of Chronic Dietary Exposure Analysis

™ 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 0.003984 mg/kg/day for the U.S. population (<1% of the
cPAD) and 0.010761 mg/kg/day (1.1% 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	0.003984	<1

All Infants (< 1 year old)1	0.010761	1

Children 1-2 years old	0.009260	1

Children 3-5 years old	0.007258	<1

Children 6-12 years old	0.004219	<1

Youth 13-19 years old	0.002741	<1

Adults 20-49 years old	0.003461	<1

Adults 50+ years old	0.003659	<1

Females 13-49 years old	0.003472	<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%
of the aPAD at the 95th percentile of exposure.  Estimated chronic
dietary exposures are less than or equal to 1.1% 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 CYAZOFAMID

Residue file name: C:\DEEMFCID\DEEMFCIDAACIERTO\cyazofamid\D357043 acute
cyazofamid food + water.R98 Analysis Date 03-26-2009

Residue file dated: 03-26-2009/15:14:19/8

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

Comment: Acute Food + Drinking Water using CTCA Drinking Water estimate
(scenario #3): Females 13-49 only.

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

09020210 9B   Balsam pear                        0.100000   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

09020880 9B   Chayote, fruit                     0.100000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.100000   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

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

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

86010000 O    Water, direct, all sources         0.136000   1.000  1.000

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  RESULT FILE

U.S. Environmental Protection Agency                             Ver.
2.02

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

Residue file: D357043 acute cyazofamid food + water.R98

Adjustment factor #2 NOT used.

Analysis Date: 03-26-2009/16:58:40  Residue file dated:
03-26-2009/15:14:19/8

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

Daily totals for food and foodform consumption used.

Run Comment: "Acute Food + Drinking Water using CTCA Drinking Water
estimate (scenario #3): Females 13-49 only."

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

Summary calculations (per capita):

      95th Percentile           99th Percentile             99.9th
Percentile

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

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

Females 13-49 yrs:

  0.009409   0.94   10627   0.015596    1.56   6411  0.022290    2.23   
4486  

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\CYAZOFAMID.09\

chronic cyazofamid food + water.R98                       Adjust. #2 NOT
used   Analysis Date 03-26-2009  Residue file dated:
03-26-2009/16:43:49/8

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

Comment:Chronic Food + 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   

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   

09020880 9B   Chayote, fruit                     0.100000   1.000     
1.000   

09021020 9B   Chinese waxgourd                   0.100000   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   

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   

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   

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 RESULT 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\CYAZOFAMID.09\chronic cyazofamid food +
water.R98

                                              Adjustment factor #2 NOT
used.

Analysis Date 03-26-2009/16:51:02   Residue file dated:
03-26-2009/16:43:49/8

Reference dose (RfD, Chronic)= .95 mg/kg bw/day NOEL (Chronic) = 94.8
mg/kg bw/day

COMMENT 1: Chronic Food + 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)                     0.003984       23,796       
0.4%

U.S. Population (spring season)             0.003902       24,296       
0.4%

U.S. Population (summer season)             0.004324       21,924       
0.5%

U.S. Population (autumn season)             0.003841       24,680       
0.4%

U.S. Population (winter season)             0.003863       24,539       
0.4%

Northeast region                            0.003905       24,279       
0.4%

Midwest region                              0.003998       23,709       
0.4%

Southern region                             0.003701       25,612       
0.4%

Western region                              0.004489       21,120       
0.5%

Hispanics                                   0.004324       21,926       
0.5%

Non-hispanic whites                         0.003958       23,949       
0.4%

Non-hispanic blacks                         0.003672       25,814       
0.4%

Non-hisp/non-white/non-black                0.004488       21,124       
0.5%

All infants (< 1 year)                      0.010761        8,809       
1.1%

Nursing infants                             0.004073       23,276       
0.4%

Non-nursing infants                         0.013299        7,128       
1.4%

Children 1-6  yrs                           0.007625       12,433       
0.8%

Children 7-12 yrs                           0.003998       23,712       
0.4%

Females 13-19 (not preg or nursing)         0.002740       34,599       
0.3%



	



 

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Females 20+ (not preg or nursing)           0.003711       25,545       
0.4%

Females 13-50 yrs                           0.003634       26,090       
0.4%

Females 13+ (preg/not nursing)              0.003386       27,994       
0.4%

Females 13+ (nursing)                       0.004717       20,099       
0.5%

Males 13-19 yrs                             0.002726       34,772       
0.3%

Males 20+ yrs                               0.003333       28,444       
0.4%

Seniors 55+                                 0.003672       25,815       
0.4%

Children 1-2 yrs                            0.009260       10,237       
1.0%

Children 3-5 yrs                            0.007258       13,061       
0.8%

Children 6-12 yrs                           0.004219       22,469       
0.4%

Youth 13-19 yrs                             0.002741       34,584       
0.3%

Adults 20-49 yrs                            0.003461       27,391       
0.4%

Adults 50+ yrs                              0.003659       25,907       
0.4%

Females 13-49 yrs                           0.003472       27,305       
0.4%

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

Cyazofamid Dietary Exposure Assessment		DP Number:
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