Document ID: EPA-HQ-OPP-2009-0276-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-27T05:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	June  10, 2009 

SUBJECT:	Triticonazole Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessments for a Section 3
Registration Action for Seed Treatment of Cereals.

PC Code:  125620

DP Barcode:  366041

Decision No.:  399232

Registration No.:  7969-xxx

Petition No.:  8F7420

Regulatory Action:  Sec. 3 Registration

Risk Assessment Type:  Single Chemical/Aggregate

Case No.:  NA

TXR No.:  NA 

CAS No.:  131983-72-7

MRID No.:  NA

40 CFR:  180.583

FROM:	Amelia M. Acierto, Chemist 

Risk Assessment Branch 3 (RAB3)

Health Effects Division (HED) (7509P)

THROUGH:  David Soderberg, Chemist

	Nancy Dodd, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

						and

Paula Deschamp, Branch Chief

Risk Assessment Branch 3 (RAB3)

Health Effects Division (HED) (7509P)

TO:	Nancy Tsaur, Risk Assessor

Risk Assessment Branch 3 (RAB3)

Health Effects Division (HED) (7509P)

		and 

Shaja Joyner (RM Team # 20)

Fungicide Branch

Registration Division (RD) (7505P)

Executive Summary		

ion Model (DEEM-FCID™, Version 2.03) which uses food consumption data
from the U.S. Department of Agriculture’s Continuing Surveys of Food
Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses
were performed to support a Section 3 registration request for
triticonazole use as a seed treatment on cereal grains (Crop Group 15,
except rice). 

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

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

Drinking water residues were incorporated directly into the dietary
assessment using the EDWCs for triticonazole in surface water, generated
using the PRISM/EXAMS models.  For the acute assessment, the 1-in-10
year annual peak concentration of 75.5 ppb was used.  The water residues
were incorporated in the DEEM-FCID into the food categories “water,
direct, all sources” and “water, indirect, all sources.”

The acute dietary (food and drinking water) exposure assessment for
females 13-49 years was performed separately, since the acute
toxicological endpoint of concern was different from that identified for
the general U.S. population (see Table 1).  Based on the assumptions
described above, the most highly exposed population subgroup is females
13-49 years old.  However, the exposure is well below HED’s level of
concern at the 95th percentile of exposure.  Combined acute dietary
exposure from food and drinking water is <1% of the acute Population
Adjusted Dose (aPAD) for females 13-49 years old.  For the general U.S.
population and for all infants <1 year old, the exposure is  also <1 of
the aPAD.

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

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

Drinking water residues were incorporated directly into the dietary
assessment using the EDWCs for triticonazole in surface water, generated
using the PRISM/EXAMS models.  For the chronic assessment, the 1-in-10
annual mean concentration of 32.8 ppb was used.  The water residues were
incorporated in the DEEM-FCID into the food categories “water, direct,
all sources” and “water, indirect, all sources.”

Chronic dietary exposure estimates for food and drinking water combined
are also well below HED’s level of concern.  The dietary exposure is
estimated <1% of the cPAD) for the general U.S. population and 1.4% of
the cPAD for all infants (<1 year old), the population subgroup with the
highest estimated chronic dietary exposure to triticonazole.   

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

Triticonazole is classified as “Not likely to be Carcinogenic to
Humans”, therefore, the quantification of carcinogenic potential is
not applicable  (TXR Number 0054249, 4/12/2006).

 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 the 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 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 triticonazole was conducted
by Sarah Winfield (11/28/2006, DP#334039).

Residue Information

Triticonazole Use:

BASF Crop Protection has proposed use of triticonazole as a seed
treatment of the cereal grains in Crop Group 15, except rice and cereal
grains in Crop Group 16, except rice.  In connection with that use, HED
is recommending tolerances of  0.05 ppm for cereal grains (Crop Group
15, except rice) and 0.25 ppm for the forage, fodder and straw of cereal
grains (Crop Group 16, except rice) (DP#325956, A. Acierto, 6/9/2009).  

Permanent tolerances have been established in 40 CFR §80.583 (a) for
residues of the fungicide triticonazole,
(1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(H-1,2,4-triazol-
1-ylmethyl)cyclopentanol, from the treatment of seed prior to planting
in or on barley grain, hay, and straw, and wheat forage, grain, hay, and
straw at 0.05 ppm. 

No livestock tolerances have been established.  Based on the available
cow and poultry metabolism studies, and low levels of residues found in
the cereal grain (corn, rice, sorghum and wheat) field trials, there is
no reasonable expectation that quantifiable residues of triticonazole
will occur in livestock commodities [40 CFR §180.6(a)(3)]. 

No separate tolerances have been established for processed commodities. 
Processing data for corn, sorghum, and wheat showed no concentration of
triticonazole in processed commodities following seed treatment at 5x
the maximum proposed seed treatment rate.  

As determined by the HED’s Metabolism Assessment Review Committee 
(MARC) in a meeting on 5/1/2001, the residue of concern in barley,
wheat, and livestock for seed treatment uses  is triticonazole.  The
available metabolism studies supporting seed treatment uses on barley
and wheat may be extended to include seed treatment uses on all cereal
grains.

The residues of concern in drinking water (for risk assessment) are
triticonazole and its transformation products since environmental data
suggests that they have similar physical,, chemical,and toxicological
properties and, thus, are expected to be similar to triticonazole in
persistence and toxicity.  Triticonazole may be transformed in the
environment via 1) E-Z isomerization (in the presence of sunlight), 2)
hydroxylation, or 3) stepwise mineralization and potential formation of
free triazole.  Triticonazole dissipation is expected to occur primarily
via dilution in the environment.  Degradation of the parent or further
degradation of the putative toxic degradates is not expected to be
significant in the environment; degradation pathways have not been
identified. 

The requested seed treatment uses of triticonazole did not result in
increase dietary exposure estimate for free triazole or conjugated
triazoles.  Therefore, the last dietary exposure analyses for the
triazole metabolites (M. Doherty, 6 Oct. 2009) have not changed.

Residue Data used for the Acute and Chronic Assessments

The acute and chronic dietary analysis assumed that triticonazole
residues are present in/on all registered commodities at tolerance
levels and that 100% of all commodities are treated.  All processing
factors were set to 1x, based on the results of processing studies
indicating that residues of triticonazole in processed commodities would
not exceed the raw agricultural commodity (RAC) tolerances. 

 

Although seed treatment use of triticonazole on cereal grain, group 16
was proposed, the proposed use does not impact, nor result in raw
agricultural commodities for human consumption.  The food residue data
used in the acute and chronic dietary analyses are summarized in Table
1.

 

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

Commodity	Tolerance	Percent Crop Treated	Processing Factors

Cereal Grains,  Crop Group 15, except rice	

0.05 ppm	

100	

NA1

1Not applicable 

 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: “Tier II Drinking Water Assessment for the
Triticonazole Section 3 Turf Use” (C. Sutton, DP#358615, 3/24/09) and
incorporated in the DEEM-FCID into the food categories “water, direct,
all sources” and “water, indirect, all sources.”.  

The Environmental Effects Division determined that the maximum estimated
Drinking Water Concentration (EDWCs) for the seed treatment use of
triticonazole on cereal grain crop group 15 (except rice, are much lower
than the EDWCs determined for the use on turfgrass. Therefore, the EDWCs
for turfgrass were used in this dietary assessment as described below.

EFED calculated screening level surface water and ground water estimates
for triticonazole using the computer models PRZM/EXAMS (surface water)
and SCI-GROW2 (groundwater) 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/ .  

Table 2.  Tier II estimated drinking water concentrations (EDWCs)
resulting from applications of triticonazole.

Drinking water source (model)	Use 

(modeled rate)	1-in-10 year acute (ppb)	1-in-10 year chronic (ppb)	30-
year average (ppb)

Surface water (PRZM/EXAMS)	Turfgrass

(3.45 lb a.i./A/yr)	75.5	32.8	21.4

Groundwater (SCIGROW)	Turfgrass

(3.45 lb a.i./A/yr)	5.7	<5.7	<5.7

For the purpose of this dietary assessment, HED used the highest
calculated screening EDWCs for surface water: 75.5 ppb for the acute
analysis and 32.2 ppb for the chronic analysis.  This approach may
significantly overestimate dietary exposure to triticonazole 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 in the DEEM-FCID into the food categories
“water, direct, all sources” and “water, indirect, all sources.”

IV.	DEEM-FCID™ Program and Consumption Information

Triticonazole 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 (no
significance differences were identified for triticonazole).

V.	Toxicological Information

The risk assessment team confirmed endpoints that were selected
previously.  On April 5, 2001, the HED Hazard Identification Assessment
Review Committee (HIARC) reviewed the recommendations of the toxicology
reviewer for triticonazole with regard to the acute and chronic RfDs and
the toxicological endpoint selection for use as appropriate in
occupational/residential exposure/risk assessments.  The potential for
increased susceptibility of infants and children from exposure to
triticonazole was also evaluated as required by the FQPA of 1996 (TXR
Number 0014698, 10/11/2001, A. Assaad).  Additionally, the FQPA Safety
Factor Committee met on February 11, 2002 to evaluate the hazard and
exposure data for triticonazole and recommended that the FQPA Safety
Factor be removed (1x) in assessing the risk posed by this chemical (HED
DOC. NO. 0050801, 6/13/2002) because the degree of concern for pre-natal
and post-natal toxicity is low, and there are no residual uncertainties
regarding the available data in rats and mice.  The doses and
toxicological endpoints selected for various exposure scenarios are
summarized in Table 3.  On April 12, 2006, the carcinogenic potential of
triticonazole was re-evaluated by the Cancer Assessment Review Committee
(CARC).  In accordance with the EPA’s Final Guidelines for Carcinogen
Risk Assessment (March, 2005), the CARC classified triticonazole as
“Not likely to be Carcinogenic to Humans,” therefore, the
quantification of carcinogenic potential is not applicable (TXR Number
0054249, 4/12/2006).  

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

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD,
Level of Concern 	Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)
NOAEL= 400 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Acute RfD = 4 mg/kg/day

aPAD =4 mg/kg/day	Acute Neurotoxicity - Rat

LOAEL = 2000 mg/kg/day based on increased motor activity in both sexes 

Acute Dietary

(Females 13-49 years of age)	NOAEL = 50 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Acute RfD = 0.5 mg/kg/day	Developmental - Rabbit

LOAEL = 75 mg/kg/day based on cranial variations, abortion, and
increased pre- and post-implantation losses assumed to occur following a
single dose (developmental toxicity)

Chronic Dietary (All Populations)	NOAEL= 17.4 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Chronic RfD = 0.17

mg/kg/day

cPAD = 0.17 mg/kg/day	Carcinogenicity - Mouse

LOAEL of ~ 200 mg/kg/day based on decreased body weight gain and liver
toxicity 

[LOAEL=202/209.5 mkd for males/females]

Cancer (oral, dermal, inhalation)   	Classification: “Not likely to be
Carcinogenic to Humans” based on no evidence of carcinogenicity from
studies in rats and mice.  

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.

VI.	Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned
when dietary risk exceeds 100% of the aPAD or cPAD.  The DEEM-FCID™
analyses estimate the dietary exposure of the U.S. population and
various population subgroups.  The results reported in Table 4 below 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 (Food and Drinking Water) Exposure Analysis

The results of the acute dietary exposure analysis are reported in Table
4 below.  The acute dietary (food  and drinking water) exposure
assessment was performed separately for females 13-49 yeas old since the
acute endpoint of concern is different from the acute endpoint
identified for the general U.S. population (Table 3).  Based on the
assumptions described in Sections II and V, the most highly exposed
population subgroup is female 13-49 years old, although the exposure is
well below HED’s level of concern at the 95th percentile of exposure. 
Combined acute dietary exposure from food and drinking water is
estimated at 003813 mg/kg/day, equivalent to <1% of the acute Population
Adjusted Dose (aPAD) for female 13-49 years old. 

Triticonazole acute dietary (food and drinking water) exposures at the
95th percentile for the general U.S. population and each of the
population subgroups are also well below HED’s level of concern. 
Dietary exposure was estimated at 0.004192 mg/kg/day, equivalent to <1%
of the aPAD for the general U.S. population and  0.015052 mg/kg/day,
equivalent to <1% of the aPAD for all infants (<1 year old). 

Results of Chronic Dietary Exposure Analysis   

The results of the chronic dietary exposure analysis are reported in
Table 4 below.  Chronic dietary exposure estimates for food and water
combined are well below HED’s level of concern.  The dietary exposure
is estimated at 0.000865 mg/kg/day (<1% of the cPAD) for the general
U.S. population and 0.002431 mg/kg/day (1.4% of the cPAD) for all
infants (<1 year old), the most highly exposed population subgroup.   



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

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	

0.004192	

<1.0	

0.000865	

<1.0	N/A	N/A

All Infants (< 1 year old)	

0.015052	<1.0

(0.38)	

0.002431	

1.4

Children 1-2 years old	

0.006674	 

<1.0	

0.001422	

<1.0

Children 3-5 years old	

0.006171	

<1.0	

0.001376	

<1.0

Children 6-12 years old	

0.004301	

<1.0	

0.000959	

<1.0

Youth 13-19 years old	

0.003414	

<1.0	

0.000694	

<1.0

Adults 20-49 years old	

0.003806	

<1.0	

0.000787	

<1.0

Adults 50+ years old	

0.003426	

<1.0	

0.000781	

<1.0

Females 13-49 years old	

0.003813	<1.0

(0.76)	

0.000777	

<1.0

* The acute endpoint for females 13-49 years old is different from the
acute endpoint identified for all the other subpopulations. The bolded
values indicate the highest exposed population for each type of risk
assessment.

VII.	Characterization of Inputs/Outputs

The acute and chronic dietary exposure and risk estimates are highly
conservative since these assumes that 100% of the crops are treated with
triticonazole and that residues are present at tolerance levels even
though actual residues from field trials were less than the tolerance
level (0.05 ppm). In addition, drinking water exposure estimates were
based on screening level estimates generated by the PRZM-EXAMS model
which resulted to higher point estimates and therefore are more
protective than the SCIGROW 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

 dietary exposure analyses using DEEM-FCID™ indicate that acute (at
the 95th percentile) and chronic dietary exposures to triticonazole are
well below HED’s level of concern for seed treatment use of the
fungicide on the cereal grain crop group 15, except rice.  The
assessments can be considered highly conservative as they assume all the
subject crops are treated and bear residues at the tolerance level. 
Actual exposure is likely to be much lower.

IX.		List of Attachments

	Attachment 1: Acute Dietary (Food Plus Water) Residue Input file.

	Attachment 2: Acute Dietary (Food plus Water) Results file for Female
13-49 years old.

Attachment 3: Acute Dietary (Food plus Water) Results file for the
General U.S.Population                                                  
          

	Attachment 4: Chronic Dietary (Food plus Water) Residue Input file.

	Attachment 5: Chronic Dietary (Food plus Water) Results file.

Attachment 1: Acute Dietary (Food plus Water) Residue Input file.

U.S. Environmental Protection Agency                                Ver.
2.02

DEEM-FCID Acute analysis for TRITICONAZOLE

Residue file name: C:\Documents and Settings\aacierto\My
Documents\DEEM-FCID
Files\deemfcid\Deemfcid\Triticonazole\triticonazoleAcute.R98

Analysis Date 06-16-2009            Residue file dated:
06-16-2009/11:09:58/8

Reference dose: aRfD = 4 mg/kg bw/day  NOEL = 400 mg/kg bw/day

Comment: cereal grain seed treatment

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

15000250 15   Barley, pearled barley             0.050000   1.000  1.000

15000251 15   Barley, pearled barley-babyfood    0.050000   1.000  1.000

15000260 15   Barley, flour                      0.050000   1.000  1.000

15000261 15   Barley, flour-babyfood             0.050000   1.000  1.000

15000270 15   Barley, bran                       0.050000   1.000  1.000

15000650 15   Buckwheat                          0.050000   1.000  1.000

15000660 15   Buckwheat, flour                   0.050000   1.000  1.000

15001200 15   Corn, field, flour                 0.050000   1.000  1.000

15001201 15   Corn, field, flour-babyfood        0.050000   1.000  1.000

15001210 15   Corn, field, meal                  0.050000   1.000  1.000

15001211 15   Corn, field, meal-babyfood         0.050000   1.000  1.000

15001220 15   Corn, field, bran                  0.050000   1.000  1.000

15001230 15   Corn, field, starch                0.050000   1.000  1.000

15001231 15   Corn, field, starch-babyfood       0.050000   1.000  1.000

15001240 15   Corn, field, syrup                 0.050000   1.000  1.000

15001241 15   Corn, field, syrup-babyfood        0.050000   1.000  1.000

15001250 15   Corn, field, oil                   0.050000   1.000  1.000

15001251 15   Corn, field, oil-babyfood          0.050000   1.000  1.000

15001260 15   Corn, pop                          0.050000   1.000  1.000

15001270 15   Corn, sweet                        0.050000   1.000  1.000

15001271 15   Corn, sweet-babyfood               0.050000   1.000  1.000

15002260 15   Millet, grain                      0.050000   1.000  1.000

15002310 15   Oat, bran                          0.050000   1.000  1.000

15002320 15   Oat, flour                         0.050000   1.000  1.000

15002321 15   Oat, flour-babyfood                0.050000   1.000  1.000

15002330 15   Oat, groats/rolled oats            0.050000   1.000  1.000

15002331 15   Oat, groats/rolled oats-babyfood   0.050000   1.000  1.000

15003280 15   Rye, grain                         0.050000   1.000  1.000

15003290 15   Rye, flour                         0.050000   1.000  1.000

15003440 15   Sorghum, grain                     0.050000   1.000  1.000

15003450 15   Sorghum, syrup                     0.050000   1.000  1.000

15003810 15   Triticale, flour                   0.050000   1.000  1.000

15003811 15   Triticale, flour-babyfood          0.050000   1.000  1.000

86010000 O    Water, direct, all sources         0.075500   1.000  1.000

86020000 O    Water, indirect, all sources       0.075500   1.000  1.000

15004010 15   Wheat, grain                       0.050000   1.000  1.000

15004011 15   Wheat, grain-babyfood              0.050000   1.000  1.000

15004020 15   Wheat, flour                       0.050000   1.000  1.000

15004021 15   Wheat, flour-babyfood              0.050000   1.000  1.000

15004030 15   Wheat, germ                        0.050000   1.000  1.000

15004040 15   Wheat, bran                        0.050000   1.000  1.000

Attachment 2: Acute Dietary (Food plus Water) Results file for Female
13-49 years old.

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: triticonazoleAcute.R98          Adjustment factor #2 NOT
used.

Analysis Date: 06-16-2009/11:14:47  Residue file dated:
06-16-2009/11:09:58/8

NOEL (Acute) = 400.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "cereal grain seed treatment"

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

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

Females 13-49 yrs:

  0.003813   0.10  104905  0.006039    0.15   66239  0.010651   0.27  
37554  

Attachment 3: Acute Dietary (Food plus Water) Results file for the
General U.S. Population

U.S. Environmental Protection Agency                                Ver.
2.02

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

Residue file: triticonazoleAcute.R98           Adjustment factor #2 NOT
used.

Analysis Date: 06-16-2009/11:34:26  Residue file dated:
06-16-2009/11:09:58/8

NOEL (Acute) = 400.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "cereal grain seed treatment"

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

Summary calculations (per capita):

      95th Percentile            99th Percentile           99.9th
Percentile

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

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

U.S. Population:

  0.004192    0.10   95430  0.007666   0.19   52180  0.015105    0.38  
26481  

All infants:

  0.015052    0.38   26574  0.021515   0.54   18591  0.038065    0.95  
10508  

Children 1-2 yrs:

  0.006674    0.17   59931  0.011069   0.28   36137  0.015453    0.39  
25885  

Children 3-5 yrs:

  0.006171    0.15   64815  0.009504   0.24   42086  0.015442    0.39  
25902  

Children 6-12 yrs:

  0.004301    0.11   92992  0.006979   0.17   57315  0.009335    0.23  
42848  

Youth 13-19 yrs:

  0.003414    0.09  117156  0.005572   0.14   71783  0.009812    0.25  
40767  

Adults 20-49 yrs:

  0.003806    0.10  105090  0.006271   0.16   63789  0.011201    0.28  
35709  

Adults 50+ yrs:

  0.003426    0.09  116767  0.004894   0.12   81728  0.007830    0.20  
51084  

Attachment 4: Chronic Dietary (Food plus Water) Residue Input file.

U.S. Environmental Protection Agency                               Ver.
2.00

DEEM-FCID Chronic analysis for TRITICONAZOLE                     1994-98
data

Residue file: C:\Documents and Settings\aacierto\My Documents\DEEM-FCID
Files\deemfcid\Deemfcid\Triticonazole\triticonazoleChronic.R98          
                                          Adjust. #2 NOT used

Analysis Date 06-16-2009            Residue file dated:
06-16-2009/10:41:14/8

Reference dose (RfD) = 0.174  (NOEL) = 17.4 mg/kg bw/day

Comment:cereal grain seed treatment

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

15000250 15   Barley, pearled barley             0.050000   1.000     
1.000   

15000251 15   Barley, pearled barley-babyfood    0.050000   1.000     
1.000   

15000260 15   Barley, flour                      0.050000   1.000     
1.000   

15000261 15   Barley, flour-babyfood             0.050000   1.000     
1.000   

15000270 15   Barley, bran                       0.050000   1.000     
1.000   

15000650 15   Buckwheat                          0.050000   1.000     
1.000   

15000660 15   Buckwheat, flour                   0.050000   1.000     
1.000   

15001200 15   Corn, field, flour                 0.050000   1.000     
1.000   

15001201 15   Corn, field, flour-babyfood        0.050000   1.000     
1.000   

15001210 15   Corn, field, meal                  0.050000   1.000     
1.000   

15001211 15   Corn, field, meal-babyfood         0.050000   1.000     
1.000   

15001220 15   Corn, field, bran                  0.050000   1.000     
1.000   

15001230 15   Corn, field, starch                0.050000   1.000     
1.000   

15001231 15   Corn, field, starch-babyfood       0.050000   1.000     
1.000   

15001240 15   Corn, field, syrup                 0.050000   1.000     
1.000   

15001241 15   Corn, field, syrup-babyfood        0.050000   1.000     
1.000   

15001250 15   Corn, field, oil                   0.050000   1.000     
1.000   

15001251 15   Corn, field, oil-babyfood          0.050000   1.000     
1.000   

15001260 15   Corn, pop                          0.050000   1.000     
1.000   

15001270 15   Corn, sweet                        0.050000   1.000     
1.000   

15001271 15   Corn, sweet-babyfood               0.050000   1.000     
1.000   

15002260 15   Millet, grain                      0.050000   1.000     
1.000   

15002310 15   Oat, bran                          0.050000   1.000     
1.000   

15002320 15   Oat, flour                         0.050000   1.000     
1.000   

15002321 15   Oat, flour-babyfood                0.050000   1.000     
1.000   

15002330 15   Oat, groats/rolled oats            0.050000   1.000     
1.000   

15002331 15   Oat, groats/rolled oats-babyfood   0.050000   1.000     
1.000   

15003280 15   Rye, grain                         0.050000   1.000     
1.000   

15003290 15   Rye, flour                         0.050000   1.000     
1.000   

15003440 15   Sorghum, grain                     0.050000   1.000     
1.000   

15003450 15   Sorghum, syrup                     0.050000   1.000     
1.000   

15003810 15   Triticale, flour                   0.050000   1.000     
1.000   

15003811 15   Triticale, flour-babyfood          0.050000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.032800   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.032800   1.000     
1.000   

15004010 15   Wheat, grain                       0.050000   1.000     
1.000   

15004011 15   Wheat, grain-babyfood              0.050000   1.000     
1.000   

15004020 15   Wheat, flour                       0.050000   1.000     
1.000   

15004021 15   Wheat, flour-babyfood              0.050000   1.000     
1.000   

15004030 15   Wheat, germ                        0.050000   1.000     
1.000   

15004040 15   Wheat, bran                        0.050000   1.000     
1.000   

Attachment 5: Chronic Dietary (Food plus Water) Results file.

U.S. Environmental Protection Agency                               Ver.
2.00

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

Residue file name: C:\Documents and Settings\aacierto\My
Documents\DEEM-FCID
Files\deemfcid\Deemfcid\Triticonazole\triticonazoleChronic.R98

                                               Adjustment factor #2 NOT
used.

Analysis Date 06-16-2009/10:42:04   Residue file dated:
06-16-2009/10:41:14/8

Reference dose (RfD, Chronic) = .174 mg/kg bw/day

NOEL (Chronic) = 17.4 mg/kg bw/day

COMMENT 1: cereal grain seed treatment

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

                    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)                     0.000865       20,111       
0.5%

U.S. Population (spring season)             0.000862       20,192       
0.5%

U.S. Population (summer season)             0.000920       18,907       
0.5%

U.S. Population (autumn season)             0.000839       20,742       
0.5%

U.S. Population (winter season)             0.000839       20,736       
0.5%

Northeast region                            0.000801       21,724       
0.5%

Midwest region                              0.000886       19,643       
0.5%

Southern region                             0.000825       21,101       
0.5%

Western region                              0.000965       18,023       
0.6%

Hispanics                                   0.000962       18,080       
0.6%

Non-hispanic whites                         0.000849       20,504       
0.5%

Non-hispanic blacks                         0.000832       20,910       
0.5%

Non-hisp/non-white/non-black                0.001002       17,361       
0.6%

All infants (< 1 year)                      0.002431        7,158       
1.4%

Nursing infants                             0.000909       19,147       
0.5%

Non-nursing infants                         0.003008        5,784       
1.7%

Children 1-6  yrs                           0.001366       12,736       
0.8%

Children 7-12 yrs                           0.000912       19,088       
0.5%

Females 13-19 (not preg or nursing)         0.000656       26,540       
0.4%

Females 20+ (not preg or nursing)           0.000804       21,650       
0.5%



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emales 13-50 yrs                           0.000811       21,460       
0.5%

Females 13+ (preg/not nursing)              0.000808       21,527       
0.5%

Females 13+ (nursing)                       0.001103       15,774       
0.6%

Males 13-19 yrs                             0.000728       23,915       
0.4%

Males 20+ yrs                               0.000761       22,873       
0.4%

Seniors 55+                                 0.000778       22,367       
0.4%

Children 1-2 yrs                            0.001422       12,240       
0.8%

Children 3-5 yrs                            0.001376       12,646       
0.8%

Children 6-12 yrs                           0.000959       18,139       
0.6%

Youth 13-19 yrs                             0.000694       25,069       
0.4%

Adults 20-49 yrs                            0.000787       22,101       
0.5%

Adults 50+ yrs                              0.000781       22,289       
0.4%

Females 13-49 yrs                           0.000777       22,398       
0.4%

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

Triticonazole	Dietary Exposure and Risk Assessment	DP Number: 366041	

PC Code:  125260														    Decision Number: 399232

________________________________________________________________________
______________

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