Document ID: EPA-HQ-OPP-2011-0906-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-09-26T04:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460      

	OFFICE OF CHEMICAL SAFETY AND

                                                                        
                      POLLUTION PREVENTION

	

MEMORANDUM

Date:  		30-APR-2012  

SUBJECT:	Cyazofamid Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessments for the Section 3
Registration Action on Basil, Succulent Beans, the Fruiting Vegetable
Group 8-10, the Leafy Greens Subgroup 4A, and the Tuberous and Corm
Vegetable Subgroup 1C.  

PC Code: 085651 	DP Barcode:  D397214 

Decision No.: 456373	Registration No.: 71512-3

Petition No.: 1E7929	Regulatory Action: Section 3 Registration

Risk Assessment Type:  NA	Case No.: None

TXR No.: NA	CAS No.: 120116-88-3

MRID No.: None	40 CFR: 180.601

FROM:	Nancy Dodd, Chemist

Registration Action Branch III (RAB3)

Health Effects Division (HED; 7509P)

THROUGH:	Thomas Bloem, Chemist

William Cutchin, Chemist

Dietary Exposure Science Advisory Council (DESAC)

HED (7509P)

and

Paula Deschamp, Branch Chief

RAB3/HED (7509P)

TO:		Nancy Tsaur, Chemist

RAB3/HED (7509P)

and

Barbara Madden/Laura Nollen, RM #5

Risk Integration, Minor Use and Emergency Response Branch

		Registration Division (7505P)

Executive Summary

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 Section 3 requests for uses on basil, succulent
beans, the fruiting vegetable group 8-10, the leafy greens subgroup 4A,
and the tuberous and corm vegetable subgroup 1C.

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

The conservative 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.
 The acute dietary (food and drinking water) exposure assessment is
conservative, i.e., based on the assumption that residues in all crops
are at the tolerance levels and that 100% of the crops are treated (100%
CT).  All processing factors were set to 1x, based on the results of
processing studies demonstrating that residues of cyazofamid in
processed commodities would not exceed the level in the raw agricultural
commodity (RAC) tolerances, except that default processing factors were
used for dried tomatoes and tomato juice since those commodities are not
required to be analyzed in processing studies.  The acute estimated
drinking water concentration (EDWC) of 136.2 ppb was modeled using Tier
2 PRZM/EXAMS (Pesticide Root Zone Model/Exposure Analysis Modeling
System) for residues in surface water from use on turf and ornamentals,
which yielded the highest acute EDWC considering all registered/proposed
uses.  The acute dietary risk assessment shows that the acute dietary
risk estimates are below HED’s level of concern (i.e., <100% of the
acute population adjusted dose (aPAD)).  The acute dietary risk estimate
for females 13-49 years old at the 95th percentile of exposure was 2.5%
of the aPAD.  

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

The chronic dietary (food and drinking water) exposure assessment is
conservative, i.e., based on the assumption that residues in all crops
are at the tolerance levels and that 100% of the crops are treated (100%
CT).  All processing factors were set to 1x, based on the results of
processing studies demonstrating that residues of cyazofamid in
processed commodities would not exceed the level in the raw agricultural
commodity (RAC) tolerances, except that default processing factors were
used for dried tomatoes and tomato juice since those commodities are not
required to be analyzed in processing studies.  The chronic EDWC of
133.5 ppb was modeled using Tier 2 PRZM/EXAMS (Pesticide Root Zone
Model/Exposure Analysis Modeling System) for residues in surface water
from use on turf and ornamentals, which yielded the highest chronic EDWC
considering all registered/proposed uses.  The chronic dietary risk
assessment shows that the chronic dietary risk estimates are below
HED’s level of concern (i.e., <100% of the chronic population adjusted
dose (cPAD)).  For the general U.S. population, the exposure for food
and drinking water utilized <1% of the cPAD.  The chronic dietary risk
estimate for the highest reported exposed population subgroup, children
(1-2 years old), utilized 1.5% of the cPAD.  

Cancer Dietary (Food and Drinking Water) Exposure Results and
Characterization

A cancer dietary risk assessment was not conducted since cyazofamid is
classified as “not likely to be carcinogenic to humans.”

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 point of departure (POD, NOAEL, LOAEL,
e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when
estimated dietary risk exceeds 100% of the PAD.  HED is generally
concerned when estimated cancer risk exceeds one in one million. 
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,”
21-JUN-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 (20-AUG-1999).

The most recent dietary risk assessment for cyazofamid was conducted by
Roger Chesser (25-MAY-2010, DP# D376585).

II.	Residue Information

Tolerances:  Permanent tolerances are established in 40 CFR §180.601 on
various raw agricultural commodities (RACs) at levels ranging from 0.02
ppm on potato to 12.0 ppm on turnip greens and the Brassica leafy greens
subgroup 5B.  A tolerance with regional registration is established on
grape at 1.5 ppm.  Time-limited tolerances under Section 18 have been
established on dried basil at 144 ppm and fresh basil at 12 ppm; these
tolerances will expire on 12/31/14.  No tolerances have been established
on livestock commodities.  Compliance with all tolerances specified in
40 CFR §180.601 is to be determined by measuring only the sum of
cyazofamid and its metabolite CCIM, calculated as the stoichiometric
equivalent of cyazofamid.  

Residues of Concern: The HED Metabolism Assessment Review Committee
(MARC) determined in a meeting on 2/18/04 that the residues of concern
for risk assessment are parent and CCIM in plants, parent only in
rotational crops, and parent, CCIM, CCIM-AM, and CTCA in water.  For
livestock commodities, the proposed and established uses fall under 40
CFR §180.6(a)(3), i.e., there is no reasonable expectation of finite
residues in livestock commodities.

Residue Data Used for Acute and Chronic Assessments

The conservative acute and chronic analyses assumed that cyazofamid
residues are present in/on all proposed/registered food commodities at
tolerance levels and that 100% of all commodities are treated.  Adequate
processing data are available for grapes (MRID 45409028), tomatoes (MRID
45409031), and potatoes (MRID 45409033 and MRID 46537730).  The results
of these studies indicate that combined residues of cyazofamid and CCIM
in processed commodities are not expected to exceed the tolerances on
the raw agricultural commodities.  Therefore, processing factors were
set to 1x, except that default processing factors were used for dried
tomatoes and tomato juice since those commodities are not required to be
analyzed in processing studies.  The food residue data used in the acute
and chronic analyses are summarized in Table 1 below.

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

Commodity	Recommended Tolerance (ppm)	Percent Crop Treated	Processing
Factors

Bean, succulent	0.5	

100	

NA2

Bean, succulent, shelled	0.08

Leafy greens subgroup 4A	10

Basil, fresh leaves	30

Basil, dried leaves	1443

Vegetable, tuberous and corm, subgroup 1C	0.02

Vegetable, fruiting, group 8-10	0.9

Dried tomato  14.3

Tomato juice    1.5

1 Table 1 includes proposed crops/crop groups only.

2  NA = not applicable.

3 The time-limited tolerance of 144 ppm, which is established under the
Section 18, was used for dried basil leaves instead of the recommended
Section 3 tolerance of 90 ppm.

 Drinking Water Data

The drinking water residues used in the dietary risk assessment were
provided by the Environmental Fate and Effects Division (EFED) in the
following memorandum: “Estimated Drinking Water Concentrations of
Cyazofamid and its Degradates of Concern CCIM, CCIM-AM and CTCA, for Use
in Human Health Risk Assessment:  IR-4 Petition for the Use on Succulent
Beans, Shelled Beans, Leafy Greens Subgroup 4A, Basil (Fresh and Dried
Leaves), Tuberous and Corm Vegetables Subgroup 1C, and Fruiting
Vegetables Group 8-10” (J. Meléndez, 10-FEB-2012, DP# D396052) and
incorporated directly into this dietary assessment.  Water residues were
incorporated in the DEEM-FCID into the food categories “water, direct,
all sources” and “water, indirect, all sources.”   

As shown in Table 2 below, the acute value of 136.2 ppb and the
non-cancer chronic value of 133.5 ppb were the EDWCs which were directly
entered into the exposure model to assess the contributions from
drinking water.  These EDWCs were modeled using Tier 2 PRZM/EXAMS
(Pesticide Root Zone Model/Exposure Analysis Modeling System) for
residues in surface water from use on turf and ornamentals, which had
the highest seasonal rates among the proposed and registered uses. 
Acute and chronic EDWCs in ground water as modeled by Tier 1 SCI-GROW
(Screening Concentration in Ground Water) were lower (2.18 ppb).

  

Table 2.  Surface/Ground Water EDWCs for Cyazofamid and 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

3rd  Scenario 	CTCA	136.242	133.458	2.18000

The model and its description are available at the EPA internet site:  
HYPERLINK "http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/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 assessment, an estimate of the residue
level in each food or food-form (e.g., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form to produce a residue intake
estimate.  The resulting residue intake estimate for each food/food form
is summed with the residue intake estimates for all other food/food
forms on the commodity residue list to arrive at the total average
estimated exposure.  Exposure is expressed in mg/kg body weight/day and
as a percent of the cPAD.  This procedure is performed for each
population subgroup.

For acute exposure assessments, individual one-day food consumption data
are used on an individual-by-individual basis.  The reported consumption
amounts of each food item can be multiplied by a residue point estimate
and summed to obtain a total daily pesticide exposure for a
deterministic exposure assessment, or “matched” in multiple random
pairings with residue values and then summed in a probabilistic
assessment.  The resulting distribution of exposures is expressed as a
percentage of the aPAD on both a user (i.e., only those who reported
eating relevant commodities/food forms) and a per-capita (i.e., those
who reported eating the relevant commodities as well as those who did
not) basis.  In accordance with HED policy, per capita exposure and risk
are reported for all tiers of analysis.  However, for tiers 1 and 2, any
significant differences in user vs. per capita exposure and risk are
specifically identified and noted in the risk assessment.

V.	Toxicological Information

The risk assessment team selected endpoints that were selected
previously (Ghazi Dannan, 15-APR-2004, TXR# 0052428, Cyazofamid
[IKF-916] – Report of the Hazard Identification Assessment Review
Committee).

The HED cyazofamid risk assessment team has recommended that the FQPA
Safety Factor be reduced to 1X (DP# D356837, N. Tsaur, 20-MAY-2009; DP#
D370671, N. Tsaur, 7-APR-2010).  In brief, the toxicology database is
adequate for the purpose of characterization of potential pre- and
postnatal risks to infants and children.  The concern is low for the
quantitative susceptibility seen in the rat developmental toxicity study
and there are no residual uncertainties.  There were no indications of
pre-and/or postnatal toxicity and no residual uncertainties from the
rabbit developmental study or the rat two-generation reproduction study.
 Although a subchronic neurotoxicity study is not available, the acute
neurotoxicity study showed no neurotoxic effects.  Neurotoxicity and
immunotoxicity were not demonstrated in the available studies.  The
dietary (food and water) and residential exposure assessments are
conservative and are not likely to underestimate the potential
exposures.



Table 3.	Summary of Toxicological Doses and Endpoints for Cyazofamid for
Use in Dietary Exposure Risk Assessments.

Exposure/

Scenario	Point of Departure

(PoD)	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern 	Study
and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)	No
adverse effects were observed which could be attributed to a single-dose
exposure for the general population.

Acute Dietary

(Females 13-49 years of age)	NOAEL = 100 mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF = 1X	Acute RfD = 1.0  mg/kg/day

aPAD = 1.0 mg/kg/day	Rat Prenatal Developmental Toxicity (MRID 45408933)

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

Chronic Dietary (All Populations)	NOAEL= 94.8 mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF = 1X	Chronic RfD = 0.95 mg/kg/day

cPAD = 0.95 mg/kg/day	18-Month Mouse Oral Carcinogenicity (MRID
45408932)

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

Cancer (oral, dermal, inhalation)	Classification:  “Not likely to be
Carcinogenic to Humans” based on the absence of significant tumor
increases in two adequate rodent carcinogenicity studies.

Point of Departure (POD) = A data point or an estimated point that is
derived from observed dose-response data and used to mark the beginning
of extrapolation to determine risk associated with lower environmentally
relevant human exposures.  NOAEL = no observed adverse effect level. 
LOAEL = lowest observed adverse effect level.  UF = uncertainty factor. 
UFA = extrapolation from animal to human (interspecies).  UFH =
potential variation in sensitivity among members of the human population
(intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population
adjusted dose (a = acute, c = chronic).  RfD = reference dose.  N/A =
not applicable.

VI.	Results/Discussion 

ceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary
exposure of the U.S. population and various population subgroups.  The
results reported in Table 4 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 old.  Cancer
risk is determined for the general U.S. population only.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

An 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.  

The acute dietary (food and drinking water) exposure assessment is
conservative, i.e., based on the assumption that residues in all crops
are at the tolerance levels and that 100% of the crops are treated (100%
CT).  The acute dietary risk assessment shows that the acute dietary
risk estimates are below HED’s level of concern (i.e., <100% of the
acute population adjusted dose (cPAD)).  The acute dietary risk estimate
for females 13-49 years old at the 95th percentile of exposure was 2.5%
of the aPAD.  The results of the acute dietary exposure analysis are
reported in Table 4 below.  

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The chronic dietary (food and drinking water) exposure assessment is
conservative, i.e., based on the assumption that residues in all crops
are at the tolerance levels and that 100% of the crops are treated (100%
CT).  The chronic dietary risk assessment shows that the chronic dietary
risk estimates are below HED’s level of concern (i.e., <100% of the
chronic population adjusted dose (cPAD)).  For the general U.S.
population, the exposure for food and drinking water utilized <1% of the
cPAD.  The chronic dietary risk estimate for the highest reported
exposed population subgroup, children (1-2 years old), was 1.5% of the
cPAD.  The results of the chronic dietary exposure analysis are reported
in Table 4 below.  

Table 4.    Summary of Dietary (Food and Drinking Water) Exposure and
Risk for Cyazofamid.

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary	Cancer

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

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

(mg/kg/day)	Risk

General U.S. Population	

NA1	

NA	0.008157        	<1%

All Infants (< 1 year old)

	0.012989        	1.4	N/A	N/A

Children 1-2 years old

	0.014334        	1.5

Children 3-5 years old

	0.012279	1.3

Children 6-12 years old

	0.008139	<1%

Youth 13-19 years old

	0.006274	<1%

Adults 20-49 years old

	0.007733	<1%

Adults 50+ years old

	0.007855	<1%

Females 13-49 years old	0.024799    	2.5	0.007725	<1%

1  NA = Not Applicable

VII.	Characterization of Inputs/Outputs

The acute and chronic dietary exposure and risk estimates are
conservative since they assume that 100% of the crops are treated with
cyazofamid and that residues are present at tolerance levels.  In
addition, EDWCs 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 the Agency’s level of concern, such refinement is not warranted.

VIII.	Conclusions

These conservative dietary exposure analyses using DEEM-FCID™ indicate
that acute and chronic dietary exposures to cyazofamid from food and
drinking water are well below the Agency’s level of concern.  Both
assessments were conservative, i.e., the assessments assumed that
residues in all crops were at tolerance levels and that 100% of the
crops were treated.  An acute endpoint was not identified for the
general U.S. population.  The estimated acute exposure of females 13-49
years old, the only population subgroup of concern for acute exposure,
represents 2.5% of the aPAD at the 95th percentile of exposure. 
Estimated chronic dietary exposures are <1% of the cPAD for the general
U.S. population and 1.5% of the cPAD for the highest reported exposed
population subgroup, children (1-2 years old).

IX.		List of Attachments

Acute Food plus Water Residue Input File.

Acute Results File.

Chronic Food Residue Input File.

Chronic Results File.

cc:	N. Dodd (RAB3/HED); N. Tsaur (RAB3/HED)

Attachment 1.  Acute Food plus Water Residue Input File

Filename: C:\Documents and Settings\NDODD\My
Documents\Deemfcidndodd\Cyazofamd\acute cyazofamid food+water 043012.R98

Chemical: cyazofamid

RfD(Chronic): .95 mg/kg bw/day  NOEL(Chronic): 94.8 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day  NOEL(Acute):  100 mg/kg bw/day

Date created/last modified: 04-30-2012/13:35:46/8          Program ver.
2.03

Comment: Drinking water using turf & ornamentals inc. parent, CCIM,
CCIM-AM

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

01010780 1AB  Carrot                             0.090000   1.000  1.000
 

01010781 1AB  Carrot-babyfood                    0.090000   1.000  1.000
 

01010790 1AB  Carrot, juice                      0.090000   1.000  1.000
 

01030150 1CD  Arrowroot, flour                   0.020000   1.000  1.000
 

01030151 1CD  Arrowroot, flour-babyfood          0.020000   1.000  1.000
 

01030170 1CD  Artichoke, Jerusalem               0.020000   1.000  1.000
 

01030820 1CD  Cassava                            0.020000   1.000  1.000
 

01030821 1CD  Cassava-babyfood                   0.020000   1.000  1.000
 

01031390 1CD  Dasheen, corm                      0.020000   1.000  1.000
 

01031660 1CD  Ginger                             0.020000   1.000  1.000
 

01031661 1CD  Ginger-babyfood                    0.020000   1.000  1.000
 

01031670 1CD  Ginger, dried                      0.020000   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
 

01033660 1CD  Sweet potato                       0.020000   1.000  1.000
 

01033661 1CD  Sweet potato-babyfood              0.020000   1.000  1.000
 

01033710 1CD  Tanier, corm                       0.020000   1.000  1.000
 

01033870 1CD  Turmeric                           0.020000   1.000  1.000
 

01034060 1CD  Yam, true                          0.020000   1.000  1.000
 

01034070 1CD  Yam bean                           0.020000   1.000  1.000
 

04010050 4A   Amaranth, leafy                   10.000000   1.000  1.000
 

04010180 4A   Arugula                           10.000000   1.000  1.000
 

04011040 4A   Chrysanthemum, garland            10.000000   1.000  1.000
 

04011330 4A   Cress, garden                     10.000000   1.000  1.000
 

04011340 4A   Cress, upland                     10.000000   1.000  1.000
 

04011380 4A   Dandelion, leaves                 10.000000   1.000  1.000
 

04011500 4A   Endive                            10.000000   1.000  1.000
 

04012040 4A   Lettuce, head                     10.000000   1.000  1.000
 

04012050 4A   Lettuce, leaf                     10.000000   1.000  1.000
 

04012480 4A   Parsley, leaves                   10.000000   1.000  1.000
 

04013130 4A   Radicchio                         10.000000   1.000  1.000
 

04013550 4A   Spinach                           10.000000   1.000  1.000
 

04013551 4A   Spinach-babyfood                  10.000000   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
 

05010640 5A   Brussels sprouts                   1.200000   1.000  1.000
 

05010690 5A   Cabbage                            1.200000   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
 

05010830 5A   Cauliflower                        1.200000   1.000  1.000
 

05011960 5A   Kohlrabi                           1.200000   1.000  1.000
 

05020630 5B   Broccoli raab                     12.000000   1.000  1.000
 

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

05021170 5B   Collards                          12.000000   1.000  1.000
 

05021940 5B   Kale                              12.000000   1.000  1.000
 

05022290 5B   Mustard greens                    12.000000   1.000  1.000
 

05023180 5B   Rape greens                       12.000000   1.000  1.000
 

05023890 5B   Turnip, greens                    12.000000   1.000  1.000
 

06010430 6A   Bean, snap, succulent              0.500000   1.000  1.000
 

06010431 6A   Bean, snap, succulent-babyfood     0.500000   1.000  1.000
 

06020310 6B   Bean, broad, succulent             0.080000   1.000  1.000
 

06020330 6B   Bean, cowpea, succulent            0.080000   1.000  1.000
 

06020370 6B   Bean, lima, succulent              0.080000   1.000  1.000
 

08001480 8    Eggplant                           0.900000   1.000  1.000
 

08002340 8    Okra                               0.900000   1.000  1.000
 

08002700 8    Pepper, bell                       0.900000   1.000  1.000
 

08002701 8    Pepper, bell-babyfood              0.900000   1.000  1.000
 

08002710 8    Pepper, bell, dried                0.900000   1.000  1.000
 

08002711 8    Pepper, bell, dried-babyfood       0.900000   1.000  1.000
 

08002720 8    Pepper, nonbell                    0.900000   1.000  1.000
 

08002721 8    Pepper, nonbell-babyfood           0.900000   1.000  1.000
 

08002730 8    Pepper, nonbell, dried             0.900000   1.000  1.000
 

08003740 8    Tomatillo                          0.900000   1.000  1.000
 

08003750 8    Tomato                             0.900000   1.000  1.000
 

08003751 8    Tomato-babyfood                    0.900000   1.000  1.000
 

08003760 8    Tomato, paste                      0.900000   1.000  1.000
 

08003761 8    Tomato, paste-babyfood             0.900000   1.000  1.000
 

08003770 8    Tomato, puree                      0.900000   1.000  1.000
 

08003771 8    Tomato, puree-babyfood             0.900000   1.000  1.000
 

08003780 8    Tomato, dried                      0.900000  14.300  1.000
 

08003781 8    Tomato, dried-babyfood             0.900000  14.300  1.000
 

08003790 8    Tomato, juice                      0.900000   1.500  1.000
 

09010750 9A   Cantaloupe                         0.100000   1.000  1.000
 

09010800 9A   Casaba                             0.100000   1.000  1.000
 

09011870 9A   Honeydew melon                     0.100000   1.000  1.000
 

09013990 9A   Watermelon                         0.100000   1.000  1.000
 

09014000 9A   Watermelon, juice                  0.100000   1.000  1.000
 

09020210 9B   Balsam pear                        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
 

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
 

19010280 19A  Basil, fresh leaves               30.000000   1.000  1.000
 

19010281 19A  Basil, fresh leaves-babyfood      30.000000   1.000  1.000
 

19010290 19A  Basil, dried leaves              144.000000   1.000  1.000
 

19010291 19A  Basil, dried leaves-babyfood     144.000000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.136200   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.136200   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
 

95001880 O    Hop                               10.000000   1.000  1.000
 

Attachment 2.  Acute 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 043012.R98

    Adjustment factor #2 used.

Analysis Date: 04-30-2012/13:37:42    Residue file dated:
04-30-2012/13:35:46/8

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

Daily totals for food and foodform consumption used.

Run Comment: "Drinking water using turf & ornamentals inc. parent, CCIM,
CCIM-

AM"

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

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

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

Females 13-49 yrs:

  0.024799    2.48    4032    0.041882    4.19    2387    0.068117   
6.81    1468  

Attachment 3.  Chronic Food Residue Input File.

Filename: C:\Documents and Settings\NDODD\My
Documents\Deemfcidndodd\Cyazofamd\chronic cyazofamid food+water
041912.R98

Chemical: cyazofamid

RfD(Chronic): .95 mg/kg bw/day  NOEL(Chronic): 94.8 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day  NOEL(Acute):  100 mg/kg bw/day

Date created/last modified: 04-19-2012/14:21:55/8          Program ver.
2.03

Comment: Drinking water using turf and ornamentals inc. only CTCA 

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

01010780 1AB  Carrot                             0.090000   1.000  1.000
 

01010781 1AB  Carrot-babyfood                    0.090000   1.000  1.000
 

01010790 1AB  Carrot, juice                      0.090000   1.000  1.000
 

01030150 1CD  Arrowroot, flour                   0.020000   1.000  1.000
 

01030151 1CD  Arrowroot, flour-babyfood          0.020000   1.000  1.000
 

01030170 1CD  Artichoke, Jerusalem               0.020000   1.000  1.000
 

01030820 1CD  Cassava                            0.020000   1.000  1.000
 

01030821 1CD  Cassava-babyfood                   0.020000   1.000  1.000
 

01031390 1CD  Dasheen, corm                      0.020000   1.000  1.000
 

01031660 1CD  Ginger                             0.020000   1.000  1.000
 

01031661 1CD  Ginger-babyfood                    0.020000   1.000  1.000
 

01031670 1CD  Ginger, dried                      0.020000   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
 

01033660 1CD  Sweet potato                       0.020000   1.000  1.000
 

01033661 1CD  Sweet potato-babyfood              0.020000   1.000  1.000
 

01033710 1CD  Tanier, corm                       0.020000   1.000  1.000
 

01033870 1CD  Turmeric                           0.020000   1.000  1.000
 

01034060 1CD  Yam, true                          0.020000   1.000  1.000
 

01034070 1CD  Yam bean                           0.020000   1.000  1.000
 

04010050 4A   Amaranth, leafy                   10.000000   1.000  1.000
 

04010180 4A   Arugula                           10.000000   1.000  1.000
 

04011040 4A   Chrysanthemum, garland            10.000000   1.000  1.000
 

04011330 4A   Cress, garden                     10.000000   1.000  1.000
 

04011340 4A   Cress, upland                     10.000000   1.000  1.000
 

04011380 4A   Dandelion, leaves                 10.000000   1.000  1.000
 

04011500 4A   Endive                            10.000000   1.000  1.000
 

04012040 4A   Lettuce, head                     10.000000   1.000  1.000
 

04012050 4A   Lettuce, leaf                     10.000000   1.000  1.000
 

04012480 4A   Parsley, leaves                   10.000000   1.000  1.000
 

04013130 4A   Radicchio                         10.000000   1.000  1.000
 

04013550 4A   Spinach                           10.000000   1.000  1.000
 

04013551 4A   Spinach-babyfood                  10.000000   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
 

05010640 5A   Brussels sprouts                   1.200000   1.000  1.000
 

05010690 5A   Cabbage                            1.200000   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
 

05010830 5A   Cauliflower                        1.200000   1.000  1.000
 

05011960 5A   Kohlrabi                           1.200000   1.000  1.000
 

05020630 5B   Broccoli raab                     12.000000   1.000  1.000
 

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

05021170 5B   Collards                          12.000000   1.000  1.000
 

05021940 5B   Kale                              12.000000   1.000  1.000
 

05022290 5B   Mustard greens                    12.000000   1.000  1.000
 

05023180 5B   Rape greens                       12.000000   1.000  1.000
 

05023890 5B   Turnip, greens                    12.000000   1.000  1.000
 

06010430 6A   Bean, snap, succulent              0.500000   1.000  1.000
 

06010431 6A   Bean, snap, succulent-babyfood     0.500000   1.000  1.000
 

06020310 6B   Bean, broad, succulent             0.080000   1.000  1.000
 

06020330 6B   Bean, cowpea, succulent            0.080000   1.000  1.000
 

06020370 6B   Bean, lima, succulent              0.080000   1.000  1.000
 

08001480 8    Eggplant                           0.900000   1.000  1.000
 

08002340 8    Okra                               0.900000   1.000  1.000
 

08002700 8    Pepper, bell                       0.900000   1.000  1.000
 

08002701 8    Pepper, bell-babyfood              0.900000   1.000  1.000
 

08002710 8    Pepper, bell, dried                0.900000   1.000  1.000
 

08002711 8    Pepper, bell, dried-babyfood       0.900000   1.000  1.000
 

08002720 8    Pepper, nonbell                    0.900000   1.000  1.000
 

08002721 8    Pepper, nonbell-babyfood           0.900000   1.000  1.000
 

08002730 8    Pepper, nonbell, dried             0.900000   1.000  1.000
 

08003740 8    Tomatillo                          0.900000   1.000  1.000
 

08003750 8    Tomato                             0.900000   1.000  1.000
 

08003751 8    Tomato-babyfood                    0.900000   1.000  1.000
 

08003760 8    Tomato, paste                      0.900000   1.000  1.000
 

08003761 8    Tomato, paste-babyfood             0.900000   1.000  1.000
 

08003770 8    Tomato, puree                      0.900000   1.000  1.000
 

08003771 8    Tomato, puree-babyfood             0.900000   1.000  1.000
 

08003780 8    Tomato, dried                      0.900000  14.300  1.000
 

08003781 8    Tomato, dried-babyfood             0.900000  14.300  1.000
 

08003790 8    Tomato, juice                      0.900000   1.500  1.000
 

09010750 9A   Cantaloupe                         0.100000   1.000  1.000
 

09010800 9A   Casaba                             0.100000   1.000  1.000
 

09011870 9A   Honeydew melon                     0.100000   1.000  1.000
 

09013990 9A   Watermelon                         0.100000   1.000  1.000
 

09014000 9A   Watermelon, juice                  0.100000   1.000  1.000
 

09020210 9B   Balsam pear                        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
 

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
 

19010280 19A  Basil, fresh leaves               30.000000   1.000  1.000
 

19010281 19A  Basil, fresh leaves-babyfood      30.000000   1.000  1.000
 

19010290 19A  Basil, dried leaves              144.000000   1.000  1.000
 

19010291 19A  Basil, dried leaves-babyfood     144.000000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.133500   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.133500   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
 

95001880 O    Hop                               10.000000   1.000  1.000
 

95003800 O    Tomato, Tree                       0.900000   1.000  1.000
 Attachment 4.  Chronic 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\NDODD\My
Documents\Deemfcidndodd\Cyazofamd\chronic cyazofamid food+water
041912.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 04-26-2012/16:09:22     Residue file dated:
04-19-2012/14:21:55/8

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

COMMENT 1: Drinking water using turf and ornamentals inc. only CTCA

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.008157                
0.9%

U.S. Population (spring season)             0.008177                
0.9%

U.S. Population (summer season)             0.008382                
0.9%

U.S. Population (autumn season)             0.008035                
0.8%

U.S. Population (winter season)             0.008032                
0.8%

Northeast region                            0.008203                
0.9%

Midwest region                              0.008064                
0.8%

Southern region                             0.007651                
0.8%

Western region                              0.009020                
0.9%

Hispanics                                   0.008152                
0.9%

Non-hispanic whites                         0.007995                
0.8%

Non-hispanic blacks                         0.008239                
0.9%

Non-hisp/non-white/non-black                0.010614                
1.1%

All infants (< 1 year)                      0.012989                
1.4%

Nursing infants                             0.005056                
0.5%

Non-nursing infants                         0.016000                
1.7%

Children 1-6  yrs                           0.012576                
1.3%

Children 7-12 yrs                           0.007814                
0.8%

Females 13-19 (not preg or nursing)         0.006145                
0.6%

Females 20+ (not preg or nursing)           0.008154                
0.9%

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           0.007838                 0.8%

Females 13+ (preg/not nursing)              0.006836                
0.7%

Females 13+ (nursing)                       0.009165                
1.0%

Males 13-19 yrs                             0.006349                
0.7%

Males 20+ yrs                               0.007385                
0.8%

Seniors 55+                                 0.007790                
0.8%

Children 1-2 yrs                            0.014334                
1.5%

Children 3-5 yrs                            0.012279                
1.3%

Children 6-12 yrs                           0.008139                
0.9%

Youth 13-19 yrs                             0.006274                
0.7%

Adults 20-49 yrs                            0.007733                
0.8%

Adults 50+ yrs                              0.007855                
0.8%

Females 13-49 yrs                           0.007725                
0.8%

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

Cyazofamid	Dietary Exposure and Risk Assessment	DP Number: D397214	

PC Code: 085651		

________________________________________________________________________
______________

Page   PAGE  1  of   NUMPAGES   15