Document ID: EPA-HQ-OPP-2007-1161-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-11-14T05:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

Date:		26-June-2008

Subject:	Tetraconazole.  Acute and Chronic Dietary Exposure and Risk
Assessment for Application of Tetraconazole to Grape.  

PC Code:  120603	DP Barcode:  353708

Decision No.:  385790	Registration No.:  none

Petition No.:  7E7273	Regulatory Action:  Section 3

Risk Assessment Type:  Dietary	Case No.:  none

TXR No.:  not applicable	CAS No.:  112281-77-3

MRID No:  none	40 CFR:  180.557

From/To:	Tom Bloem, Chemist

			Registration Action Branch 1/Health Effects Division (RAB1/HED;
7509P)

Through:	Debra Rate, Biologist, Risk Integration Minor Use & Emergency
Response Branch 	(RIMUEB)/Registration Division (RD)

			Dave Soderberg, Chemist, Reregistration Branch 3 (RRB3)/HED

			Dietary Exposure Science Advisory Committee (DESAC) Secondary Review

			George F. Kramer, Ph.D., Senior Chemist

			RAB1/HED (7509P)

Executive Summary

The residues of concern following application of tetraconazole includes
compounds which HED has determined to be toxicologically different from
tetraconazole.  The current memorandum pertains only to exposure to
tetraconazole and those compounds which HED has determined are
toxicologically equivalent to tetraconazole (information concerning
exposure to the remaining compounds can be found in the HED risk
assessment; D347084, M. Clock-Rust et al., in draft).  

Acute, chronic, and cancer dietary risk assessments were conducted using
the Dietary Exposure Evaluation Model - Food Consumption Intake Database
(DEEM-FCID™, ver. 2.03) which incorporates the food consumption data
from the USDA’s Continuing Surveys of Food Intakes by Individuals
(CSFII; 1994-1996 and 1998).  These analyses were conducted in support
of the proposed application of tetraconazole to grape.  The following
paragraphs are summaries of the acute, chronic, and cancer analyses.  

Acute:  The tier 1 acute analysis (food and water) resulted in exposure
estimate for females 13-49 years old less than HED’s level of concern
(<1% acute population adjusted dose (aPAD); acute endpoint of concern
was not identified for the general population including infants and
children).  

rop treated assumed for food commodities).  The resulting exposure
estimates are less than HED's level of concern (≤8% cPAD; all infants
<1 year old were the most highly exposed population subgroup).  

Cancer:  The cancer analysis was refined through the incorporation of
empirical processing factors, average field trial residues, average
residues from the feeding studies, and projected percent crop treated
estimates (food and feed).  The resulting exposures estimates yielded a
cancer risk for the U.S. population of 3 x 10-6 which is less than HED's
level of concern (see Table 8).  A critical commodity analysis for the
cancer run (U.S. population) indicated that water (62% of total
exposure) and soybean oil (21% of total exposure) were the major
contributors to the cancer exposure.  

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 PAD.  The PAD is equivalent
to the point of departure divided by the required uncertainty and/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,” 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 dietary risk assessment for
tetraconazole was conducted by T. Bloem (D342525, 22-Aug-2007).

II.  Residue Information

Residues of Concern in Plants and Livestock:  Table 1 is a summary of
the residues of concern in plants and livestock (for a complete
discussion concerning these conclusions, refer to D321751, M. Clock-Rust
et al., 26-Jan-2007).  HED has concluded that the toxicological effects
resulting from exposure to 1,2,4-triazole (T), triazolyl alanine (TA),
triazolyl acetic acid (TAA), triazolyl hydroxypropionic acid (THP), and
all labile conjugates of these compounds and M14360(C-1)-alcohol are
different from that resulting from exposure to tetraconazole; HED
concluded that the toxicity of the remaining metabolites are identical
to that of tetraconazole.  The current dietary exposure analysis
pertains only to exposure to those compounds which HED has concluded are
toxicologically similar to tetraconazole (i.e. tetraconazole,
M14360-alcohol (free and conjugated), M14360-acid, M14360-DFA, and
M14360-hydroxydetriazolyl-O-malonyldiglucoside).  Information concerning
exposure to the remaining compounds can be found in the HED risk
assessment; D347084 (M. Clock-Rust et al., in draft).

Table 1:  Residues for Tolerance Expression and Risk Assessment.

Matrix	Residues included in Risk Assessment	Residues included in
Tolerance Expression

Shelled Pea 

and Bean	tetraconazole and 1,2,4-triazole (T), triazolyl alanine (TA),
triazolyl acetic acid (TAA), and all labile conjugates of these
compounds	tetraconazole

Remaining Plants	tetraconazole, M14360-alcohol (free and conjugated),
M14360-acid, M14360-DFA, M14360-hydroxydetriazolyl-O-malonyldiglucoside,
and T, TA, TAA and all labile conjugates of these compounds
tetraconazole

Livestock	tetraconazole, M14360-alcohol (free and conjugated),
M14360-acid, M14360-DFA, M14360(C-1)-alcohol (free and conjugated),
M14360-hydroxydetriazolyl-O-malonyldiglucoside, and T, TA, THP, and TAA
and all labile conjugates of these compounds	tetraconazole

Rotational Crops	tetraconazole, M14360-acid, M14360-DFA,
M14360(C-1)-alcohol (free and conjugated), and TA, THP, and TAA and all
labile conjugates of these compounds	tetraconazole

Drinking Water	tetraconazole	not applicable

Currently Established Tolerances and HED-Recommended Tolerances: 
Tetraconazole is currently registered for application to sugar beet,
peanut, pecan, and soybean with tolerances ranging from 0.05-0.80 ppm
(40 CFR 180.557).  Tolerances as a result of secondary residues are also
established in/on poultry and ruminant commodities (0.01-0.25 ppm).  

Residue Estimates for the Acute and Chronic Analyses:  As stated earlier
in the document, HED concluded that the toxicity of T, TA, TAA, THP, and
all labile conjugates of these compounds and M14360(C-1)-alcohol are
different from that resulting from exposure to tetraconazole.  Since the
current document is concerned with exposure to compounds which HED has
determined are toxicologically similar to tetraconazole, these compounds
were not considered.  

The petitioner submitted field trial and processing data for
tetraconazole per se.  These data are sufficient for soybean
tetraconazole risk assessment; however, the residues of concern for a
tetraconazole risk assessment in sugar beet, pecan, peanut, and grape
includes tetraconazole, M14360-alcohol (free and conjugated),
M14360-acid, M14360-DFA, and
M14360-hydroxydetriazolyl-O-malonyldiglucoside.  The magnitude of these
residues were estimated based on the tetraconazole metabolites to
tetraconazole residues ratios from the metabolism studies (sugar beet
leaves:  0.06 (0-day preharvest interval (PHI)) and 0.32-0.33 (23-35 day
PHI); root:  0.26 (23-day PHI); wheat straw:  0.02; wheat grain -
metabolites were not identified; grape metabolism studies only included
parent as a reference standard with none of the metabolites identified).
 HED concludes that the sugar beet root residue ratio is appropriate for
the currently proposed/registered crops (sugar beet (PHI = 14 days),
peanut (PHI = 14 days), pecan (PHI = 14 days), and grape (PHI = 14
days); these compounds were not identified as residues of concern in
soybean seed).  Table 3 is a summary of the tetraconazole per se
residues and estimated combined residues of concern in the plant
commodities.  

The livestock tolerances are based on residues of tetraconazole per se
derived from the consumption of feed commodities which contain
tetraconazole per se; however, as stated above, the residues of concern
for a tetraconazole risk assessment in both feed (excluding soybean feed
commodities) and livestock are tetraconazole, M14360-alcohol (free and
conjugated), M14360-acid, M14360-DFA, and
M14360-hydroxydetriazolyl-O-malonyldiglucoside.  Therefore, the acute
and chronic dietary assessment included livestock residues which were
calculated based on dietary burdens which included all of the residues
of concern for a tetraconazole risk assessment.  This dietary burden was
then used to calculate residues in the livestock tissues based on the
tetraconazole per se transfer coefficients (i.e., assessments assumes
that transfer coefficient for the tetraconazole metabolites are
identical to tetraconazole).  Table 2 is a summary of the dietary burden
calculations and Table 4 is a summary of the residue estimates in the
livestock commodities.  HED notes the following:  (1) the livestock
feeding studies (ruminant and poultry) employed a minimum of three
animals per dosing level with the highest and average residue at each
dosing level used for calculation of the acute and chronic transfer
coefficients; (2) if the acute residue estimates for the livestock
commodities in Table 4 were less than the tolerance, tolerance-level
residues were assumed; (3) HED notes that the livestock diets were
constructed by J. Stokes (HED livestock diet expert); (4) since the
dairy and beef cattle dietary burdens were nearly identical, HED
concluded that the beef tissue residues estimates may be used for goat,
horse, and sheep; and (5) the peanut and soybean application scenarios
prohibit the feeding of hay and/or forage to livestock and sugar beet
tops are being eliminated as a feed commodity from OPPTS 860.1000
(communication from J. Stokes, HED).  

Table 2:  Livestock Dietary Burden Calculations for Refinement of the
Chronic Dietary Analysis.

commodity1	% diet1	% dry matter	residue (ppm)	dietary burden2

	acute	chronic	acute	chronic

beef cattle

sugar beet dried pulp (R; 70%)	10	88	0.25	0.106	0.029	0.008

soybean hull (R; 27%)	5	90	0.15	0.046	0.008	0.0007

sugar beet molasses (CC; 70%)	10	75	0.32	0.141	0.042	0.013

aspirated grain fractions (from soybean; 27%) CC)	5	85	1.0	0.345	0.059
0.005

untreated  (CC)	60	--	--	--	--	--

soybean seed (PC; 27%)	10	89	0.15	0.046	0.017	0.001

total	100	--

	0.155	0.029

dairy cattle

sugar beet dried pulp (R; 70%)	20	88	0.25	0.106	0.057	0.017

untreated  (R)	25	--	--	--	--	--

sugar beet molasses (CC; 70%)	10	75	0.32	0.141	0.042	0.013

untreated (CC)	35	--	--	--	--	--

soybean seed (PC; 27%)	10	89	0.15	0.046	0.017	0.001

total	100

0.116	0.031

poultry

untreated (CC)	75	--	--	--	--	--

soybean meal (PC; 27%)	20	--	0.15	0.046	0.030	0.002

soybean hull (R; 27%) 	5	--	0.15	0.046	0.008	0.0006

total	100	--

	0.038	0.003

hog

untreated (CC)	85	--	--	--	--	--

soybean meal (PC; 27%)	15	--	0.15	0.046	0.022	0.002

total	100	--

	0.022	0.002

1	R = roughage, CC = carbohydrate concentrate, PC = protein concentrate;
peanut hay and soybean forage and hay are not to be fed to livestock
(therefore not included); percentage refers percent crop treated (see
attachment 1) which were used in the chronic dietary burden
calculations.

2	beef/dairy cattle dietary burden = residue x % diet ÷ % dry matter;
poultry/hog dietary burden = residue x % diet; chronic calculations
included the percent crop treated estimates.



Table 3:  Food/Feed Residue Estimates for Acute, Chronic, and Cancer
Analyses.

matrix	tetraconazole residue (ppm)	factor1	total residue2	comments

	acute	chronic/

cancer

acute	chronic/

cancer

	soybean (seed, hulls, and meal)	0.15	0.046	--3	0.15	0.046	acute
tetraconazole residue = tolerance residue

chronic tetraconazole residues = average field trial residue
(46614332.der.doc) multiplied by 2x to account for insufficient
analytical method 

soybean oil	0.80	0.212	--3	0.80	0.212	acute tetraconazole residue =
tolerance residue

chronic tetraconazole residues = average soybean seed field trial
residue multiplied by the average processing factor 4.6x
(46614320.der.doc) multiplied by 2x to account for insufficient
analytical method

soybean aspirated grain fractions	1.0	0.345	--3	1.0	0.345	acute
tetraconazole residue = tolerance residue

chronic tetraconazole residues = average soybean seed field trial
residue multiplied by the average processing factor 7.5x
(46614320.der.doc) multiplied by 2x to account for insufficient
analytical method

sugar beet root sugar	0.12	0.004	0.26	0.15	0.005	acute tetraconazole
residue = tolerance residue

chronic tetraconazole residues = average field trial residue multiplied
by 0.1x processing factor (D254411, W. Donovan, 18-May-2000, D342523, T.
Bloem, 22-Aug-2007)

sugar beet molasses	0.25	0.112	0.26	0.315	0.141	acute tetraconazole
residues = tolerance residue

chronic tetraconazole residues = average field trial residue multiplied
by 2.8x processing factor (D254411, W. Donovan, 18-May-2000, D342523, T.
Bloem, 22-Aug-2007)

sugar beet dried pulp	0.20	0.084	0.26	0.252	0.106	acute tetraconazole
residues = tolerance residue

chronic tetraconazole residues = average field trial residue multiplied
by 2.1x processing factor (D254411, W. Donovan, 18-May-2000, D342523, T.
Bloem, 22-Aug-2007)

peanut (mutmeat and meal)	0.03	0.013	0.26	0.038	0.016	acute
tetraconazole residue = tolerance residue

chronic tetraconazole residues = average field trial residue (D259231,
W. Donovan, 18-May-2000)

peanut oil	0.10	0.043	0.26	0.126	0.055	acute tetraconazole residues =
tolerance residue

chronic tetraconazole residues = average peanut field trial residue
multiplied by 3.34x processing factor (D259231, W. Donovan, 18-May-2000)

pecan	0.04	0.007	0.26	0.050	0.009	acute tetraconazole residue =
tolerance residue

chronic tetraconazole residues = average field trial residue
(46037601.der.doc)

grape	0.20	0.031	0.26	0.252	0.039	acute tetraconazole residue =
tolerance residue

chronic tetraconazole residues = average field trial residue
(47270101.der.doc)

grape juice	0.20	0.00186	0.26	0.252	0.002	acute tetraconazole residue =
tolerance residue

chronic tetraconazole residues = average field trial residue multiplied
by the 0.06x processing factor (47270101.der.doc)

raisin	0.20	0.0282	0.26	0.252	0.036	acute tetraconazole residue =
tolerance residue

chronic tetraconazole residues = average field trial residue multiplied
by the 0.91x processing factor (47270101.der.doc)

1	factor = residue ratio of non-free triazole tetraconazole metabolites
of concern to tetraconazole from the metabolism studies; sugar beet root
factor (0.26x) used for all commodities.

2	total residue = residue + (residue)(factor).

3	the non-free triazole tetraconazole metabolites are not residues of
concern in soybean seed.

Table 4:  Livestock Residues for Acute and Chronic Analysis.

matrix	tetraconazole residue from feeding study1 (ppm)	tetraconazole
transfer coeffcients2	residue estimates3

	low dosing level	middle dosing level 	high ppm dosing level	low dosing
level	middle dosing level	high dosing level	acute	chronic

dairy cattle

milk4	<0.003	max = 0.016;

avg = 0.006	max = 0.048

avg = 0.019	--	based on max res - 0.016

based on avg res - 0.006	based on max res - 0.014

based on avg res - 0.006	0.002	0.0002

milk fat	milk fat was not analyzed in the feeding studies; since
residues in fat were significantly higher than those in muscle from the
feeding studies, HED concluded that a 25x concentration factor for milk
fat was appropriate (milk fat residue = milk residue x 25)	0.046	0.0046

skimmed milk	<0.003	<0.003	max = 0.003

avg = 0.003	--	--	based on max res - 0.0009

based on avg res - 0.0009	0.001	0.0003

cream	max = 0.023

avg = 0.020	max = 0.125

avg = 0.073	max = 0.391

avg = 0.283	based on max res - 0.068

based on avg res - 0.060	based on max res - 0.122

based on avg res - 0.072	based on max res - 0.115

based on avg res - 0.083	0.014	0.0026

beef cattle/hog

subcutaneous fat	max = 0.003

avg = 0.003	max = 0.033

avg = 0.029	max = 0.205

avg = 0.109	--	based on max res - 0.032

based on avg res - 0.029	based on max res - 0.060

based on avg res - 0.032	beef = 0.0093

hog = 0.0013	beef = 0.0009

hog = 0.00006

peritoneal fat	max = 0.029

avg = 0.016	max = 0.069

avg = 0.051	max = 0.199

avg = 0.114	based on max res - 0.085

based on avg res - 0.046	based on max res - 0.068

based on avg res - 0.050	based on max res - 0.059

based on avg res - 0.033	beef = 0.0132

hog = 0.0019	beef = 0.0014

hog = 0.0001

kidney	max = 0.007

avg = 0.005	max = 0.039

avg = 0.024	max = 0.067

avg = 0.055	based on max res - 0.021

based on avg res - 0.016	based on max res - 0.038

based on avg res - 0.024	based on max res - 0.020

based on avg res - 0.016	beef = 0.0059

hog = 0.0008	beef = 0.0007

hog = 0.00005

liver	max = 0.371

avg = 0.268	max = 0.662

avg = 0.376	max = 1.636

avg = 1.345	based on max res - 1.091

based on avg res - 0.789	based on max res - 0.649

based on avg res - 0.368	based on max res - 0.481

based on avg res - 0.395	beef = 0.1691

hog = 0.0240	beef = 0.0229

hog = 0.0016

muscle	<0.003	max = 0.006

avg = 0.005	max = 0.015

avg = 0.011	--	based on max res - 0.006

based on avg res - 0.005	based on max res - 0.004

based on avg res - 0.003	beef = 0.0009

hog = 0.0001	beef = 0.0001

hog = 0.00001

poultry

liver	max = 0.011

avg = 0.010	max = 0.029

avg = 0.026	max = 0.081

avg = 0.073	based on max res - 0.159

based on avg res - 0.145	based on max res - 0.120

based on avg res - 0.108	based on max res - 0.113

based on avg res - 0.102	0.0060	0.0004

kidney	<0.01	<0.01	max = 0.049

avg = 0.040	--	--	based on max res - 0.069

based on avg res - 0.056	0.0026	0.0002

skeletal muscle	<0.01	<0.01	max = 0.021

avg = 0.021	--	--	based on max res - 0.029

based on avg res - 0.029	0.0011	0.00009

abdominal fat	max = 0.045

avg = 0.038	max = 0.140

avg = 0.115	max = 0.456

avg = 0.387	based on max res - 0.652

based on avg res - 0.551	based on max res - 0.581

based on avg res - 0.477	based on max res - 0.639

based on avg res - 0.542	0.0248	0.0017

skin and subcutaneous fat	max = 0.019

avg = 0.015	max = 0.044

avg = 0.041	max = 0.181

avg = 0.164	based on max res - 0.275

based on avg res - 0.217	based on max res - 0.183

based on avg res - 0.170	based on max res - 0.253

based on avg res - 0.230	0.0104	0.0007

eggs5	max = 0.011

avg = 0.008	max = 0.034

avg = 0.025	max = 0.135

avg = 0.089	based on max res - 0.159

based on avg res - 0.116	based on max res - 0.141

based on avg res - 0.104	based on max res - 0.189

based on avg res - 0.125	0.0072	0.0004

1	ruminant feeding study - D254411, W. Donovan, 18 May-2000 (dietary
burdens of 0.34 ppm, 1.02 ppm, and 3.4 ppm); poultry feeding study -
46614307.der.wpd (dietary burdens of 0.069 ppm, 0.241 ppm, and 0.714
ppm); the livestock feeding studies (ruminant and poultry) employed a
minimum of three animals per dosing level with the highest and average
residue at each dosing level used for calculation of the acute and
chronic transfer coefficients.

2	transfer coefficient = tetraconazole residues in tissue, egg, or milk
÷ dietary burden; for the acute analysis the residues in bold were <
tolerance therefore defaulted to the tolerance.

3	residue estimate = dietary burden x transfer coefficient; the highest
transfer coefficient derived from a dosing level which resulted in
quantifiable residues was used.

4	residues in milk peaked on the third day of dosing; therefore, the
average residue is for all samples collected on day 3 and after.

5	residues in egg peaked on the tenth day of dosing; therefore, the
average residue is for all samples collected on day 10 and after.

III.  Drinking Water Data

EFED provided modeled ground (Screening Concentration In Ground Water
(SCIGROW)) and surface (Pesticide Root Zone Model (PRZM 3.12) and
Exposure Analysis Modeling System (EXAMS 2.98.04)) water concentrations
for tetraconazole per se (EFED memorandum; D347085, I. Maher,
5-June-2008).  Table 5 is a summary of the water estimates provided by
EFED (bolded number were used in the assessment).  The water estimates
were incorporated directly into the dietary exposure analysis via the
water sources direct (all sources) and indirect (all sources)
commodities.  The water models and their description are available at
the EPA internet site:   HYPERLINK
"http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .  

Tetraconazole is currently registered for application to sugar beet,
peanut, pecan and soybean and is being proposed for application to
grape.  Since the application rates for grape and soybean are
significantly lower than the application rates for sugar beet, peanut,
and pecans, EFED concluded that modeling using the grape and soybean
application scenarios were unnecessary.  Also, the surface/ground water
estimate for pecan have dropped considerably from those attained as part
of the previous assessment as the petitioner has changed the pecan
application scenario permitting only four applications rather than
eight.  

Table 5.  Summary of Ground and Surface Water Modeled Water Estimates.

Scenario	Tetraconazole per se concentration (μg/L; ppb)

	Peak	Yearly	30 Year Annual Average

Minnesota Sugar Beets1

Aerial spray	6.68	4.68	3.29

Ground spray	6.22	4.22	2.87

North Carolina Peanuts2

Aerial spray	5.95	3.51	2.99

Ground spray	5.51	3.22	2.71

Georgia Pecans3

Aerial spray	10.45	3.48	2.84

Ground spray	10.03	3.26	2.61

1   SEQ CHAPTER \h \r 1 EXAMS EEC multiplied by 0.87 to account for
percent of basin cropped (assumes 100% of the crop treated).

2 EXAMS EEC multiplied by 0.67 to account for percent of basin cropped
(assumes 100% of the crop treated).

3 EXAMS EEC multiplied by 0.85 to account for percent of basin cropped
(assumes 100% of the crop treated).

IV.  DEEM-FCID™ Program and Consumption Information

Acute and chronic dietary exposure assessments were conducted using
DEEM-FCID™ (ver. 2.03) which incorporates consumption data from
USDA’s 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 HED Hazard Identification Assessment Review Committee (HIARC) met on
14-September-1999 (HED Doc. No. 013765) and 13-May-2004 (TXR No.
0052657) to select endpoints for risk assessment and to evaluate the
potential for increased susceptibility of infants and children from
exposure to tetraconazole (evaluated according to the February 2002 OPP
10X guidance document).  The HED Cancer Assessment Review Committee met
on 10-November-1999 and classified tetraconazole as a likely human
carcinogen (HED Doc. No. 013948).  The HIARC, based on toxicological
considerations recommended for a 1x Food Quality Protection Act Safety
Factor (FQPA SF).  Based on toxicological considerations (evaluated by
HIARC) and the residue assumptions used in the dietary analyses
(evaluated by the reviewer), it was concluded that the FQPA Safety
Factor should be reduced to 1x when assessing dietary exposures.  Table
6 summarizes the endpoints used for dietary exposure assessment.   

Table 6:  Summary of Toxicological Doses and Endpoints for Tetraconazle
Dietary Exposure Assessment1

Exposure Scenario	Dose Used in Risk

Assessment, UF	FQPA SF* and Dose for Risk Assessment	Study and
Toxicological Effects

Acute Dietary - general population (including infants and children)	None
N/A	No endpoint attributable to a single exposure was identified.  This
risk assessment is not required.

Acute Dietary - Females 13-50 years of age	NOAEL = 22.5 mg/kg/day

UF = 100

aRfD = 0.225 mg/kg/day	FQPA SF = 1X

aPAD = aRfD ÷ FQPA SF

= 0.225 mg/kg	Oral developmental toxicity study - rat

Developmental NOAEL = 22.5 mg/kg/day, based on increased incidence of
small fetuses, and supernumerary ribs. 

Chronic Dietary -

all populations	NOAEL= 0.73 mg/kg/day

UF =100

cRfD = 0.0073 mg/kg/day	FQPA SF = 1 

cPAD = cRfD ÷ FQPA SF

cPAD = 0.0073 mg/kg/day 	Chronic oral toxicity - dog 

Systemic Toxicity LOAEL = 2.95/3.33 (M/F) mg/kg/day, based on absolute
and relative kidney weights and histopathological changes in the male
kidney.

Cancer	Classification: “likely to be carcinogenic to humans” Q1*= 
2.30 x 10-2, based on male mouse liver benign and/or malignant combined
tumor rates.

1	NOAEL = No-Observed-Adverse-Effect-Level; LOAEL =
Lowest-Observed-Adverse-Effect-Level; UF = Uncertainty Factor; RfD =
Reference Dose; PAD = Chronic Population Adusted Dose = RfD ÷ FQPA SF.

VI.  Results/Discussion & Conclusions

Acute:  The Tier 1 acute analysis resulted in exposure estimate for
females 13-49 years old which are less than HED's level of concern (<1%
aPAD; see Table 7); an acute endpoint of concern was not identified for
the general population including infants and children.  

Chronic:  The chronic analysis was refined through the incorporation of
empirical processing factors, average field trial residues, average
residues from the feeding studies, and projected percent crop treated
estimates for the feed commodities (100% crop treated assumed for food
commodities).  The resulting exposure estimates are less than HED's
level of concern (≤8% cPAD; all infants <1 year old were the most
highly exposed population subgroup; see Table 7).  

Cancer:  The cancer analysis was refined through the incorporation of
empirical processing factors, average field trial residues, average
residues from the feeding studies, and projected percent crop treated
estimates (food and feed).  The resulting exposures estimates yielded a
cancer risk for the U.S. population of 3 x 10-6 (2.6 x 10-6 rounded to
3.0 x 10-6; see Table 8).  

Cancer risks presented in this assessment are expressed to one
significant figure.  However, it should be noted that, in general, the
precision which can be assumed for cancer risk estimates is best
described by rounding to the nearest integral order of magnitude on the
log scale, e.g., 3.16 x 10-7 to 3.16 x 10-6, expressed as 10-6.  Risks
are generally reported to one significant figure in HED risk assessments
to allow better characterization of changes in risk which might result
from potential risk mitigation.  This rounding procedure indicates that
risks should generally not be assumed to exceed the benchmark level of
concern of 10-6 until the calculated risks exceed approximately 3 x
10-6.  Discretion should be used in interpreting the significance of
these calculated risks with consideration given to the precision in the
risk estimates.

Table 7:  Summary of the Acute and Chronic Dietary Exposure and Risk.

Population	aPAD (mg/kg/day)	Exposure (mg/kg/day)1	%aPAD	cPAD (mg/kg/day)
Exposure (mg/kg/day)	%cPAD

General U.S. Population	no acute endpoint identified for these
population subgroups	0.073	0.000210	3

All Infants (< 1 year old)

	0.000563	8

Children 1-2 years old

	0.000399	6

Children 3-5 years old

	0.000385	5

Children 6-12 years old

	0.000267	4

Youth 13-19 years old

	0.000178	2

Adults 20-49 years old

	0.000182	2

Adults 50+ years old

	0.000173	2

Females 13-49 years old	0.225	0.001697	<1

0.000178	2

1	95th percentile (tier 1 analysis)

Table 8:  Summary of the Cancer Dietary Exposure and Risk.

Population1	Exposure (mg/kg/day)	Q1*	Cancer risk

General U.S. population	0.000112	0.023	2.6 x 10-6

1	exposure for the general U.S. population; HED performs cancer analyses
for only the general U.S. population.

VII.  Characterization of Inputs/Outputs

The acute analysis could be refined through the incorporation of maximum
or highest average field trial residues, percent crop treated estimates,
and/or monitoring data.  The chronic/cancer analyses incorporated
average field trial residues, average residues from the feeding studies,
and/or projected percent CT information and could be further refined
through the incorporation of monitoring data.  A critical-commodity
analysis conducted for the general U.S. population cancer assessment
indicates that water (62% of the total exposure) and soybean oil (21% of
the total exposure) are the major contributors.

VIII.  Conclusions

The acute (<1% of the aPAD), chronic (≤8% of the cPAD), and cancer (3
x 10-6) exposure estimates are not of concern to HED.  

Attachment 1:  BEAD percent crop treated information

Attachment 2:  DEEM-FCID™ acute exposure estimates

Attachment 3:  DEEM-FCID™ acute residue file

Attachment 4:  DEEM-FCID™ chronic exposure estimates

Attachment 5:  DEEM-FCID™ chronic residue file

Attachment 6:  DEEM-FCID™ cancer exposure estimates

Attachment 7:  DEEM-FCID™ cancer residue file

Attachment 8:  Critical Commodity Analysis for the Cancer Analysis

CC with all attachments:  Susan Stanton (RD; 7505P)

T. Bloem:S10945:PY:(703)605-0217:7509P

Attachment 1:  BEAD percent crop treated information

  SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE OF

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES

						

MEMORANDUM

SUBJECT:	Projected Percent Crop Treated for the Fungicide Tetraconazole
on Three Crops: Peanuts, Soybeans, and Sugar Beets.

FROM:		Jihad Alsadek, Economist

Science Information & Analysis Branch

Biological and Economic Analysis Division (7503P)

			

			Richard Michell, Plant Pathologist

			Biological Analysis Branch

			Biological and Economic Analysis Division (7503P)

TO:			Mary Waller, Product Manager

			Fungicide Branch

			Registration Division (7505P)

THRU:	Diann Sims, Chief

			Science Information Analysis Branch

			Biological and Economic Analysis Division (7503P)

			Arnet Jones, Chief

			Biological Analysis Branch

			Biological and Economic Analysis Division (7503P)

PRP Review: November 29, 2006

I.	SUMMARY

	This memorandum provides projected percent crop treated (PPCT) values
for tetraconazole on three crops (peanuts, soybeans, and sugar beets),
as well as the corresponding Federal Register (FR) language.  The
methodology used to produce the estimates is outlined below, along with
the analysis of additional biological information that could impact the
assessments.  The market leader approach is only used with peanuts;
other approaches are used with soybeans and sugar beets.  The registrant
Isa Gro input and expert opinions are used for soybeans, and the sugar
beet regional value is adjusted for a national one.  We have examined
all the relevant data and conclude that it is unlikely that the actual
percent crop treated (PCT) values for tetraconazole on peanuts, soybeans
and sugar beets in the next five years will exceed the PPCTs provided
for tetraconazole on these three crops. Numbers to be used in risk
analysis are shown in table 1.

Table 1. Values to be used in Risk Assessment

Crop	Chronic	Acute

Peanuts	77	88

Soybeans	27	38

Sugar Beets	70	70

II.	FR LANGUAGE

EPA estimates projected percent crop treated (PPCT) for a new pesticide
use by assuming that the percent crop treated (PCT) during the
pesticide’s initial five years of use on a specific use site will not
exceed the average PCT of the market leader (i.e., the one with the
greatest PCT) on that site.

Typically, EPA uses USDA/NASS as the primary source for PCT data.  When
a specific use site is not surveyed by USDA/NASS, EPA uses other sources
including proprietary data and calculates the PCT.  Comparisons are only
made among pesticides of the same pesticide types (i.e., the leading
fungicide on the use site is selected for comparison with the new
fungicide).  The PCTs included in the average may be for the same
pesticide, or for different pesticides, since the same, or different
pesticides, may dominate for each year selected.    This PPCT, based on
the average PCT of the market leader, is appropriate for use in chronic
dietary risk assessment. The method of estimating a PPCT for a new use
of a registered pesticide or a new pesticide produces a high-end
estimate that is unlikely, in most cases, to be exceeded during the
initial five years of actual use.  

The predominant factors that bear on whether the estimated PPCT could be
exceeded are whether new pesticide use or new pesticide is more
efficacious or controls a broader spectrum of pests than the dominant
pesticide; and/or whether there are concerns with pest pressures as
indicated in emergency exemption requests or other readily available
information; and/or other factor based on analysis of additional
information, such as the total crop acreage and the geographical
distribution of the crops and pests.

All information currently available for the predominant factors
mentioned above or relevant to the case in question have been considered
for this chemical, and it is the opinion of BEAD that it is unlikely
that actual PCT for tetraconazole will exceed the PPCT during the next
five years.  

III.	PROJECTIONS BASED ON MARKET LEADER APPROACH

The PPCTs for peanuts are calculated by averaging the PCTs of the
leading fungicide(s) for the three most recent available years.  The
PPCT for sugar beets showed a 55 percent use of tetraconazole as the
market leader for the year 2000, but 2000 USDA/NASS data for the market
leader tetraconazole is registered on sugar beets in seven states
(Colorado, Michigan, Minnesota, Montana, Nebraska, North Dakota, and
Wyoming).  NASS data are adjusted to get the acres treated in each of
the seven states, summing them up, then dividing by the sum of the
planted acres in these same states, and multiplying by 100 to get, on
average, market leader for sugar beets to be used in chronic dietary
risk assessment and acute risk too.

  The PPCTs for soybeans were based on a modified approach which is
described in the following subsection (Modified PPCT Approach for
Soybeans).



Table 2.  Projected Tetraconazole PCT Values for Dietary Risk
Assessments

Crop	Market Leaders	Average

Market Leader	Maximum

Market Leader	Years

Peanuts	Chlorothalonil 	77	88	1991, 1999, 2004

Soybeans	Unknown, but projected to be a triazole and/or strobilurin
fungicide	27	38	Future projection for next 5 years

Sugar Beets	Tetraconazole	70	70	Adjusted for year 2000

Sources:  Based on 1991 to 2004 NASS usage data for peanuts and sugar
beets.  Crop 

Specialists’ usage projections were used for soybeans.

  Market leaders could be the same chemical for all three years or could
be different for each year. 

b  Averaging the available years.

c  The highest observed percent crop treated of the available survey
years.

IV.         Modified PPCT Approach for Soybeans

Due to the recent discovery of a new and important disease on soybeans,
Asian soybean rust, historical information was not considered useful for
estimating a useful PCT for a fungicide market leader on soybeans. 
Another approach was utilized which involved obtaining PCT estimates for
future market leaders from soybean crop specialists.  The estimates were
obtained via a phone call and four list server responses enlisted by
USDA.  The five crop specialists’ PCT estimates for a market leader
ranged from 10 to 38 percent.  For a conservative estimate we utilized
only the maximum projected values provided by each respondent, which
ranged from 15 to 38 percent.  These values translated into average and
maximum PPCT values of 27 and 38 percent, respectively.

The most common factors used by the crop specialists to project the
market leader PCT were: weather patterns; prevailing winds; length of
time crop is in a growth stage that will lead to yield losses, if
infection occurs during this period; cost-effectiveness of treatments;
and market supply/availability limitations.  Some of the specific
examples provided to support their estimates were:

About 21% of the total soybean acreage is in areas where the prevailing
winds and temperature and humidity are generally unfavorable for soybean
rust infection (e.g., KS, ND, NE, SD).  

About 16% of the total soybean acreage doesn’t have the yield
potential to justify the cost of a soybean rust fungicide treatment.

In most years 40% of the soybean acreage is considered to possess a high
risk for soybean rust infection (e.g., IL, IN, OH, AR, eastern MO).

Pesticide distributors are more likely to carry stock of those soybean
rust fungicides that have other labeled uses relevant to area growers
(e.g., wheat  and corn uses in Midwestern states).  Note: The only
alternate crop uses for tetraconazole are sugar beets and peanuts, which
are not prevalent crops in most soybean production areas.

V.	ADDITIONAL FACTORS

Table 3. Biological Analysis of BEAD’s Projected Percent Crop Treated
(PPCT) for Tetraconazole on Three New Crops

NEW USES

[AVG. /MAX. PPCT]	RECENT MARKET LEADER(S) [SAMPLE YEARS]
JUSTIFICATION/COMMENTS	WILL TETRACONAZOLE EXCEED THE PCT LEVELS OF
MARKET LEADER(S)

Sugar Beets – cercospora leaf spot, 

powdery mildew 

[70/70]	tetraconazole

[2000]	Tetraconazole is the current market leader (55%), and was
previously only registered for use in 7 sugar beet producing states (CO,
MI, MN, MT, NE, ND, WY); based on the 2006 acreage planted, the addition
of 4 states (CA, ID, OR, WA) increases the potential acreage to be
treated by about 18 percent;  if all the planted acreage in these 4
additional states are treated it could bring the PPCT up to about 77%;
based upon the pest information provided in the USDA Crop Profiles it is
not likely that more than 70% of the planted acreage will be treated in
any of the 4 additional states, because the reported total fungicide
usage for these target pests is less than 70%	No

Soybeans – 

Asian soybean rust, 

cercospora, 

frog eye, 

white mold, powdery mildew, septoria, anthracnose

[27/38]	Not applicable	These values seem to be reasonable estimates for
the future market leader(s) when the following factors are considered:  

1] at least 11 active ingredients are currently available and competing
for the Asian soybean rust control market on the approximately 75
million acres grown; 

2] treatments are only warranted when weather conditions conducive to
disease development occur during the soybean bloom and/or pod fill
stages; 

3] in any given year the probability of a national epidemic which
results in the need for most of the US acreage grown in the 31 soybean
producing states being treated is low, because it would be dependent
upon the widespread occurrence of unusual weather patterns during the
critical crop growth stages; 

4] The proposed labeling allows for up to two applications per year,
which if it occurs will reduce stocks and therefore reduce the total
acreage capable of being treated; Some of the crop specialists projected
that up to 30 - 40% of the acreage in their state may be treated twice.

5] the registrant stated that only one tetraconazole product will be
marketed for the soybean use because the chemical is still under patent,
which would appear to limit the amount likely to be available throughout
the US due to supply limitations and surplus stock concerns if an
epidemic does not occur;

6] The registrant (Isa Gro), per a personal phone call on November 16,
2006, stated that although they projected they might be able to treat as
much as 5.38% of the crop if an epidemic occurred; they felt it would be
impossible to supply enough tetraconazole to treat 10% of the crop
anytime within the next 5 years.

7] Since the disease organism is not considered cold-hardy, each growing
season the disease must start its northward movement from Mexico and/or
extreme southern United States locations.  Accordingly, the northward
disease spread each year and the specific states impacted is dependent
upon wind speed and direction during humid and moderate temperature
weather.  

8] EPA has approved a wide range of active ingredients and products that
can be available to growers.  This effort was initiated because of
national concern that the supply of fungicides would not be adequate in
the case of a soybean rust epidemic.  This involved granting numerous
states permission to use seven active ingredients via Section 18
quarantine emergency exemptions, in addition to the four active
ingredients already available via Section 3 registrations.

9] Based on yields obtained in recent soybean rust efficacy studies
conducted in the US and other countries the triazole and strobilurin
fungicide classes generally seem to be the most efficacious groups of
fungicides to use (Fungicide & Nematicide Tests – Special Section on
Asian Soybean Rust Reports;   HYPERLINK
"http://www.apsnet.org/online/FNtests/" 
http://www.apsnet.org/online/FNtests/ ).  Most crop specialists predict
combinations of these two types of fungicides will be used by many
growers.

10] Since the competing fungicide tebuconazole is reportedly among the
least expensive fungicides, as well as one of the most effective
triazole fungicides, it is generally considered by crop specialists to
be the triazole fungicide of choice.  Since there are multiple products
(alone and in combinations with other fungicides) being sold by
different companies reasonable stocks are expected to be available in
most soybean production areas. 

11] Crop specialists projected that the maximum US soybean acreage to be
treated with a fungicide, if an epidemic occurred, would range from
35-65 percent (average = 54%).  Therefore if one of the eleven active
ingredients available were able to attain a 50% market share this would
only result in a maximum of 32.5% of the crop being treated with any one
fungicide.  BEAD contends that this level of market share is rarely
achieved when a number of competitive active ingredients are available. 
	No,  plus the likelihood of an epidemic although uncertain is thought
to be low

Peanuts – 

early leaf spot, late leaf spot, 

web blotch, 

rust [77/88]	chlorothalonil [ 1991, 1999, 2004]	The market leader
chlorothalonil is  typically inexpensive and is used mainly for control
of the same pests that are claimed on the proposed tetraconazole label
plus the common and important disease white mold (southern stem rot);
chlorothalonil is alternated with various systemic fungicides to delay
the development of resistant pest strains; the introduction of the
systemic fungicide tetraconazole will not likely affect
chlorothalonil’s current usage, but it is expected to share the
existing systemic fungicide market	No

VI. CONCLUSIONS/RECOMMENDATIONS

BEAD recommends that the given average PPCTs be used in the chronic
dietary risk assessment for tetraconazole, and the maximum PPCTs for
acute risk assessment.  BEAD has considered all relevant information and
believes it is unlikely that the above PPCTs will be exceeded during the
next five years for peanuts, soybeans, and sugar beets.

VII. References:

Typically, EPA uses USDA/NASS as the source for raw PCT data because it
is publicly available and does not have to be calculated from available
data sources.  When a specific use site is not surveyed by USDA/NASS,
EPA uses proprietary data and calculates the estimated PCT.

Agricultural Chemical Usage, 1990 Field Crops Summary, May 1991

Agricultural Chemical Usage, 1998 Field Crops Summary, May 1999

Agricultural Chemical Usage, 1999 Field Crops Summary, May 2000

Agricultural Chemical Usage, 2004 Field Crops Summary, May 2005

USDA, 1999, Crop Profile for Sugar Beet in California.   HYPERLINK
"http://www.ipmcenters.org/cropprofiles/docs/casugarbeets.html" 
http://www.ipmcenters.org/cropprofiles/docs/casugarbeets.html 

USDA, 2000. Crop Profile for Sugar Beet in Idaho.   HYPERLINK
"http://www.ipmcenters.org/cropprofiles/docs/IDsugarbeets.html" 
http://www.ipmcenters.org/cropprofiles/docs/IDsugarbeets.html 

USDA, 1999, Crop Profile for Sugar Beet in Oregon.   HYPERLINK
"http://www.ipmcenters.org/cropprofiles/docs/orsugarbeets.html" 
http://www.ipmcenters.org/cropprofiles/docs/orsugarbeets.html 

USDA, 2001, Crop Profile for Sugar Beet in Washington.   HYPERLINK
"http://www.ipmcenters.org/cropprofiles/docs/WAsugarbeets.html" 
http://www.ipmcenters.org/cropprofiles/docs/WAsugarbeets.html 

Attachment 2:  DEEM-FCID™ acute exposure estimates

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: 120603a.R98                         Adjustment factor #2
NOT used.

Analysis Date: 07-09-2008/07:50:23    Residue file dated:
06-17-2008/09:52:02/8

Daily totals for food and foodform consumption used.

Run Comment: "acute for females 13-50 only FQPA SF = 1x (acute and
chronic)"

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th
Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure  
% aRfD 

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

Females 13+ (preg/not nursing):

                    0.001843     0.82    0.002277     1.01    0.002703  
  1.20 

Females 13+ (nursing):

                    0.002182     0.97    0.002355     1.05    0.002383  
  1.06 

Females 13-19 (not preg or nursing):

                    0.001561     0.69    0.002829     1.26    0.005052  
  2.25 

Females 20+ (not preg or nursing):

                    0.001621     0.72    0.002778     1.23    0.004480  
  1.99 

Females 13-50 yrs:

                    0.001694     0.75    0.002806     1.25    0.004479  
  1.99 

Females 13-49 yrs:

                    0.001697     0.75    0.002813     1.25    0.004484  
  1.99 

D™ acute residue file

Filename: C:\Documents and Settings\tbloem\tetraconazole\DE memo -
grape\120603a.R98

Chemical: tetraconazole

RfD(Chronic): .0073 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .225 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .023

Date created/last modified: 06-17-2008/09:52:02/8          Program ver.
2.03

Comment: acute for females 13-50 only FQPA SF = 1x (acute and chronic)

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

95001750 O    Grape                              0.252000   1.000  1.000
 

95001760 O    Grape, juice                       0.252000   1.200  1.000
 

95001761 O    Grape, juice-babyfood              0.252000   1.200  1.000
 

95001770 O    Grape, leaves                      0.252000   1.000  1.000
 

95001780 O    Grape, raisin                      0.252000   4.300  1.000
 

95001790 O    Grape, wine and sherry             0.252000   1.200  1.000
 

95002630 O    Peanut                             0.038000   1.000  1.000
 

95002640 O    Peanut, butter                     0.038000   1.890  1.000
 

95002650 O    Peanut, oil                        0.126000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.010450   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.010450   1.000  1.000
 

21000440 M    Beef, meat                         0.010000   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.010000   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.010000   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.010000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.010000   1.000  1.000
 

21000470 M    Beef, fat                          0.020000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.020000   1.000  1.000
 

21000480 M    Beef, kidney                       0.010000   1.000  1.000
 

21000490 M    Beef, liver                        0.200000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.200000   1.000  1.000
 

23001690 M    Goat, meat                         0.010000   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.010000   1.000  1.000
 

23001710 M    Goat, fat                          0.020000   1.000  1.000
 

23001720 M    Goat, kidney                       0.010000   1.000  1.000
 

23001730 M    Goat, liver                        0.200000   1.000  1.000
 

24001890 M    Horse, meat                        0.010000   1.000  1.000
 

28002210 M    Meat, game                         0.010000   1.000  1.000
 

25002900 M    Pork, meat                         0.010000   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.010000   1.000  1.000
 

25002910 M    Pork, skin                         0.010000   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.010000   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.010000   1.000  1.000
 

25002930 M    Pork, fat                          0.010000   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.010000   1.000  1.000
 

25002940 M    Pork, kidney                       0.010000   1.000  1.000
 

25002950 M    Pork, liver                        0.050000   1.000  1.000
 

29003120 M    Rabbit, meat                       0.010000   1.000  1.000
 

26003390 M    Sheep, meat                        0.010000   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.010000   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.010000   1.000  1.000
 

26003410 M    Sheep, fat                         0.020000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.020000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.010000   1.000  1.000
 

26003430 M    Sheep, liver                       0.200000   1.000  1.000
 

40000930 P    Chicken, meat                      0.010000   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.010000   1.000  1.000
 

40000940 P    Chicken, liver                     0.010000   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.010000   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.010000   1.000  1.000
 

40000960 P    Chicken, fat                       0.050000   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.050000   1.000  1.000
 

40000970 P    Chicken, skin                      0.010400   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.010400   1.000  1.000
 

70001450 P    Egg, whole                         0.020000   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.020000   1.000  1.000
 

70001460 P    Egg, white                         0.020000   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.020000   1.000  1.000
 

70001470 P    Egg, yolk                          0.020000   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.020000   1.000  1.000
 

60003010 P    Poultry, other, meat               0.010000   1.000  1.000
 

60003020 P    Poultry, other, liver              0.010000   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.010000   1.000  1.000
 

60003040 P    Poultry, other, fat                0.050000   1.000  1.000
 

60003050 P    Poultry, other, skin               0.010400   1.000  1.000
 

50003820 P    Turkey, meat                       0.010000   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.010000   1.000  1.000
 

50003830 P    Turkey, liver                      0.010000   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.010000   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.010000   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.010000   1.000  1.000
 

50003850 P    Turkey, fat                        0.050000   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.050000   1.000  1.000
 

50003860 P    Turkey, skin                       0.104000   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.104000   1.000  1.000
 

27002220 D    Milk, fat                          0.250000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.250000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.010000   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.010000   1.000  1.000
 

27022240 D    Milk, water                        0.010000   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.010000   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.010000   1.000  1.000
 

01010520 1A   Beet, sugar                        0.150000   1.000  1.000
 

01010521 1A   Beet, sugar-babyfood               0.150000   1.000  1.000
 

01010530 1A   Beet, sugar, molasses              0.315000   1.000  1.000
 

01010531 1A   Beet, sugar, molasses-babyfood     0.315000   1.000  1.000
 

06003470 6    Soybean, seed                      0.150000   1.000  1.000
 

06003480 6    Soybean, flour                     0.150000   1.000  1.000
 

06003481 6    Soybean, flour-babyfood            0.150000   1.000  1.000
 

06003490 6    Soybean, soy milk                  0.150000   1.000  1.000
 

06003491 6    Soybean, soy milk-babyfood or in   0.150000   1.000  1.000
 

06003500 6    Soybean, oil                       0.800000   1.000  1.000
 

06003501 6    Soybean, oil-babyfood              0.800000   1.000  1.000
 

14002690 14   Pecan                              0.050000   1.000  1.000
 

Attachment 4:  DEEM-FCID™ chronic exposure estimates

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\tbloem\tetraconazole\DE
memo - grape\120603c.R98

                                                     Adjustment factor
#2 used.

Analysis Date 07-09-2008/07:47:03     Residue file dated:
06-17-2008/09:53:54/8

Reference dose (RfD, Chronic) = .0073 mg/kg bw/day

COMMENT 1: acute for females 13-50 only FQPA SF = 1x (acute and chronic)

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000210                
2.9%

U.S. Population (spring season)             0.000209                
2.9%

U.S. Population (summer season)             0.000215                
2.9%

U.S. Population (autumn season)             0.000206                
2.8%

U.S. Population (winter season)             0.000208                
2.9%

Northeast region                            0.000197                
2.7%

Midwest region                              0.000215                
3.0%

Southern region                             0.000202                
2.8%

Western region                              0.000228                
3.1%

Hispanics                                   0.000222                
3.0%

Non-hispanic whites                         0.000207                
2.8%

Non-hispanic blacks                         0.000207                
2.8%

Non-hisp/non-white/non-black                0.000233                
3.2%

All infants (< 1 year)                      0.000563                
7.7%

Nursing infants                             0.000199                
2.7%

Non-nursing infants                         0.000702                
9.6%

Children 1-6  yrs                           0.000381                
5.2%

Children 7-12 yrs                           0.000254                
3.5%

Females 13-19 (not preg or nursing)         0.000163                
2.2%

Females 20+ (not preg or nursing)           0.000178                
2.4%

Females 13-50 yrs                           0.000187                
2.6%

Females 13+ (preg/not nursing)              0.000193                
2.6%

Females 13+ (nursing)                       0.000233                
3.2%

Males 13-19 yrs                             0.000191                
2.6%

Males 20+ yrs                               0.000178                
2.4%

Seniors 55+                                 0.000172                
2.4%

Children 1-2 yrs                            0.000399                
5.5%

Children 3-5 yrs                            0.000385                
5.3%

Children 6-12 yrs                           0.000267                
3.7%

Youth 13-19 yrs                             0.000178                
2.4%

Adults 20-49 yrs                            0.000182                
2.5%

Adults 50+ yrs                              0.000173                
2.4%

DEEM-FCID™ chronic residue file

Filename: C:\Documents and Settings\tbloem\tetraconazole\DE memo -
grape\120603c.R98

Chemical: tetraconazole

RfD(Chronic): .0073 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .225 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .023

Date created/last modified: 06-17-2008/09:53:54/8          Program ver.
2.03

Comment: acute for females 13-50 only FQPA SF = 1x (acute and chronic)

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

95001750 O    Grape                              0.039000   1.000  1.000
 

95001760 O    Grape, juice                       0.002000   1.000  1.000
 

95001761 O    Grape, juice-babyfood              0.002000   1.000  1.000
 

95001770 O    Grape, leaves                      0.039000   1.000  1.000
 

95001780 O    Grape, raisin                      0.036000   1.000  1.000
 

95001790 O    Grape, wine and sherry             0.039000   1.000  1.000
 

95002630 O    Peanut                             0.016000   1.000  1.000
 

95002640 O    Peanut, butter                     0.016000   1.890  1.000
 

95002650 O    Peanut, oil                        0.055000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.004680   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.004680   1.000  1.000
 

21000440 M    Beef, meat                         0.000100   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.000100   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.000100   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.000700   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.000700   1.000  1.000
 

21000470 M    Beef, fat                          0.001400   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.001400   1.000  1.000
 

21000480 M    Beef, kidney                       0.000700   1.000  1.000
 

21000490 M    Beef, liver                        0.022900   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.022900   1.000  1.000
 

23001690 M    Goat, meat                         0.000100   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.000700   1.000  1.000
 

23001710 M    Goat, fat                          0.001400   1.000  1.000
 

23001720 M    Goat, kidney                       0.000700   1.000  1.000
 

23001730 M    Goat, liver                        0.022900   1.000  1.000
 

24001890 M    Horse, meat                        0.000100   1.000  1.000
 

28002210 M    Meat, game                         0.000100   1.000  1.000
 

25002900 M    Pork, meat                         0.000010   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.000010   1.000  1.000
 

25002910 M    Pork, skin                         0.000060   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.000050   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.000050   1.000  1.000
 

25002930 M    Pork, fat                          0.000100   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.000100   1.000  1.000
 

25002940 M    Pork, kidney                       0.000050   1.000  1.000
 

25002950 M    Pork, liver                        0.001600   1.000  1.000
 

29003120 M    Rabbit, meat                       0.000100   1.000  1.000
 

26003390 M    Sheep, meat                        0.000100   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.000100   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.000700   1.000  1.000
 

26003410 M    Sheep, fat                         0.001400   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.001400   1.000  1.000
 

26003420 M    Sheep, kidney                      0.000700   1.000  1.000
 

26003430 M    Sheep, liver                       0.022900   1.000  1.000
 

40000930 P    Chicken, meat                      0.000090   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.000090   1.000  1.000
 

40000940 P    Chicken, liver                     0.000400   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.000200   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.000200   1.000  1.000
 

40000960 P    Chicken, fat                       0.001700   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.001700   1.000  1.000
 

40000970 P    Chicken, skin                      0.000700   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.000700   1.000  1.000
 

70001450 P    Egg, whole                         0.000400   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.000400   1.000  1.000
 

70001460 P    Egg, white                         0.000400   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.000400   1.000  1.000
 

70001470 P    Egg, yolk                          0.000400   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.000400   1.000  1.000
 

60003010 P    Poultry, other, meat               0.000090   1.000  1.000
 

60003020 P    Poultry, other, liver              0.000400   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.000200   1.000  1.000
 

60003040 P    Poultry, other, fat                0.001700   1.000  1.000
 

60003050 P    Poultry, other, skin               0.000700   1.000  1.000
 

50003820 P    Turkey, meat                       0.000090   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.000090   1.000  1.000
 

50003830 P    Turkey, liver                      0.000400   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.000400   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.000200   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.000200   1.000  1.000
 

50003850 P    Turkey, fat                        0.001700   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.001700   1.000  1.000
 

50003860 P    Turkey, skin                       0.000700   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.000700   1.000  1.000
 

27002220 D    Milk, fat                          0.004600   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.004600   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.000113   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.000200   1.000  1.000
 

27022240 D    Milk, water                        0.000300   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.000300   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.000300   1.000  1.000
 

01010520 1A   Beet, sugar                        0.005000   1.000  1.000
 

01010521 1A   Beet, sugar-babyfood               0.005000   1.000  1.000
 

01010530 1A   Beet, sugar, molasses              0.141000   1.000  1.000
 

01010531 1A   Beet, sugar, molasses-babyfood     0.141000   1.000  1.000
 

06003470 6    Soybean, seed                      0.046000   1.000  1.000
 

06003480 6    Soybean, flour                     0.046000   1.000  1.000
 

06003481 6    Soybean, flour-babyfood            0.046000   1.000  1.000
 

06003490 6    Soybean, soy milk                  0.046000   1.000  1.000
 

06003491 6    Soybean, soy milk-babyfood or in   0.046000   1.000  1.000
 

06003500 6    Soybean, oil                       0.212000   1.000  1.000
 

06003501 6    Soybean, oil-babyfood              0.212000   1.000  1.000
 

14002690 14   Pecan                              0.009000   1.000  1.000
 

Attachment 6:  DEEM-FCID™ cancer exposure estimates

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\tbloem\tetraconazole\DE
memo - grape\120603cancer.R98

                                                     Adjustment factor
#2 used.

Analysis Date 07-09-2008/07:48:50     Residue file dated:
06-17-2008/12:18:39/8

Q* = 0.023 

COMMENT 1: acute for females 13-50 only FQPA SF = 1x (acute and chronic)

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .023)

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

U.S. Population (total)                     0.000112         2.57E-06

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

Attachment 7:  DEEM-FCID™ cancer residue file

Filename: C:\Documents and Settings\tbloem\tetraconazole\DE memo -
grape\120603cancer.R98

Chemical: tetraconazole

RfD(Chronic): .0073 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .225 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day Q*= .023

Date created/last modified: 06-17-2008/12:18:39/8          Program ver.
2.03

Comment: acute for females 13-50 only FQPA SF = 1x (acute and chronic)

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

95001750 O    Grape                              0.039000   1.000  1.000
 

95001760 O    Grape, juice                       0.002000   1.000  1.000
 

95001761 O    Grape, juice-babyfood              0.002000   1.000  1.000
 

95001770 O    Grape, leaves                      0.039000   1.000  1.000
 

95001780 O    Grape, raisin                      0.036000   1.000  1.000
 

95001790 O    Grape, wine and sherry             0.039000   1.000  1.000
 

95002630 O    Peanut                             0.016000   1.000  0.770
 

95002640 O    Peanut, butter                     0.016000   1.890  0.770
 

95002650 O    Peanut, oil                        0.055000   1.000  0.770
 

86010000 O    Water, direct, all sources         0.003290   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.003290   1.000  1.000
 

21000440 M    Beef, meat                         0.000100   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.000100   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.000100   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.000700   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.000700   1.000  1.000
 

21000470 M    Beef, fat                          0.001400   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.001400   1.000  1.000
 

21000480 M    Beef, kidney                       0.000700   1.000  1.000
 

21000490 M    Beef, liver                        0.022900   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.022900   1.000  1.000
 

23001690 M    Goat, meat                         0.000100   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.000700   1.000  1.000
 

23001710 M    Goat, fat                          0.001400   1.000  1.000
 

23001720 M    Goat, kidney                       0.000700   1.000  1.000
 

23001730 M    Goat, liver                        0.022900   1.000  1.000
 

24001890 M    Horse, meat                        0.000100   1.000  1.000
 

28002210 M    Meat, game                         0.000100   1.000  1.000
 

25002900 M    Pork, meat                         0.000010   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.000010   1.000  1.000
 

25002910 M    Pork, skin                         0.000060   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.000050   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.000050   1.000  1.000
 

25002930 M    Pork, fat                          0.000100   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.000100   1.000  1.000
 

25002940 M    Pork, kidney                       0.000050   1.000  1.000
 

25002950 M    Pork, liver                        0.001600   1.000  1.000
 

29003120 M    Rabbit, meat                       0.000100   1.000  1.000
 

26003390 M    Sheep, meat                        0.000100   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.000100   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.000700   1.000  1.000
 

26003410 M    Sheep, fat                         0.001400   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.001400   1.000  1.000
 

26003420 M    Sheep, kidney                      0.000700   1.000  1.000
 

26003430 M    Sheep, liver                       0.022900   1.000  1.000
 

40000930 P    Chicken, meat                      0.000090   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.000090   1.000  1.000
 

40000940 P    Chicken, liver                     0.000400   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.000200   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.000200   1.000  1.000
 

40000960 P    Chicken, fat                       0.001700   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.001700   1.000  1.000
 

40000970 P    Chicken, skin                      0.000700   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.000700   1.000  1.000
 

70001450 P    Egg, whole                         0.000400   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.000400   1.000  1.000
 

70001460 P    Egg, white                         0.000400   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.000400   1.000  1.000
 

70001470 P    Egg, yolk                          0.000400   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.000400   1.000  1.000
 

60003010 P    Poultry, other, meat               0.000090   1.000  1.000
 

60003020 P    Poultry, other, liver              0.000400   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.000200   1.000  1.000
 

60003040 P    Poultry, other, fat                0.001700   1.000  1.000
 

60003050 P    Poultry, other, skin               0.000700   1.000  1.000
 

50003820 P    Turkey, meat                       0.000090   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.000090   1.000  1.000
 

50003830 P    Turkey, liver                      0.000400   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.000400   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.000200   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.000200   1.000  1.000
 

50003850 P    Turkey, fat                        0.001700   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.001700   1.000  1.000
 

50003860 P    Turkey, skin                       0.000700   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.000700   1.000  1.000
 

27002220 D    Milk, fat                          0.004600   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.004600   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.000113   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.000200   1.000  1.000
 

27022240 D    Milk, water                        0.000300   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.000300   1.000  1.000
 



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01010520 1A   Beet, sugar                        0.005000   1.000  0.700
 

01010521 1A   Beet, sugar-babyfood               0.005000   1.000  0.700
 

01010530 1A   Beet, sugar, molasses              0.141000   1.000  0.700
 

01010531 1A   Beet, sugar, molasses-babyfood     0.141000   1.000  0.700
 

06003470 6    Soybean, seed                      0.046000   1.000  0.270
 

06003480 6    Soybean, flour                     0.046000   1.000  0.270
 

06003481 6    Soybean, flour-babyfood            0.046000   1.000  0.270
 

06003490 6    Soybean, soy milk                  0.046000   1.000  0.270
 

06003491 6    Soybean, soy milk-babyfood or in   0.046000   1.000  0.270
 

06003500 6    Soybean, oil                       0.212000   1.000  0.270
 

06003501 6    Soybean, oil-babyfood              0.212000   1.000  0.270
 

14002690 14   Pecan                              0.009000   1.000  1.000
 

Attachment 8:  Critical Commodity Analysis for the Cancer Analysis 

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\tbloem\tetraconazole\DE
memo - grape\120603cancer.R98

                                                     Adjustment factor
#2 used.

Analysis Date 07-09-2008/07:49:24     Residue file dated:
06-17-2008/12:18:39/8

Q* = 0.023 

COMMENT 1: acute for females 13-50 only FQPA SF = 1x (acute and chronic)

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

                 Critical Commodity Contribution Analysis for

                            U.S. Population (total)

                 Total Exposure =.0001116 mg/kg bw/day

            Crop groups with total exposure contribution > 1%

              Foods/Foodforms with exposure contribution > 1%

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

Crop group                               -----------Exposure
analysis----------

   Food                                     mg/kg   | % of Total|
Lifetime Risk

      Foodform                           body wt/day|  Exposure |(Q*=
.023)

--------------------------------------  
-----------|-----------|--------------

Crop Group = (O)  Other

   Grape (95001750):

        FoodForm N/S                       0.0000038     3.42%       
8.77E-08

   Grape, wine and sherry (95001790):

        FoodForm N/S                       0.0000050     4.48%       
1.15E-07

   Peanut, butter (95002640):

        FoodForm N/S                       0.0000012     1.05%       
2.69E-08

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0000399    35.78%       
9.18E-07

   Water, indirect, all sources (86020000):

        FoodForm N/S                       0.0000294    26.37%       
6.77E-07

--------------------------------------  
-----------|-----------|--------------

  Total for crop group                     0.0000812    72.72%       
1.87E-06

Crop Group = (D)  Dairy Products

   Milk, fat (27002220):

        FoodForm N/S                       0.0000015     1.37%       
3.51E-08

   Milk, water (27022240):

        FoodForm N/S                       0.0000017     1.48%       
3.80E-08

--------------------------------------  
-----------|-----------|--------------

  Total for crop group                     0.0000033     2.95%       
7.57E-08

Crop Group = (1)  Root and Tuber Vegetables

  Total for crop group                     0.0000013     1.12%       
2.88E-08

Crop Group = (6)  Legume Vegetables (Succulent or Dried)

   Soybean, oil (06003500):

        FoodForm N/S                       0.0000238    21.30%       
5.47E-07

--------------------------------------  
-----------|-----------|--------------

  Total for crop group                     0.0000251    22.49%       
5.77E-07

Total for crop groups listed above:        0.0001108    99.28%       
2.55E-06

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

Tetraconazole	Dietary Exposure and Risk Assessment	D353708

Page   PAGE  11  of   NUMPAGES  26 

Page   PAGE  16  of   NUMPAGES  26