Document ID: EPA-HQ-OPP-2007-0312-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-06-03T04:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	3/11/09  

SUBJECT:	Triflumizole Amended Acute and Chronic Dietary (Food and
Drinking Water) Exposure and Risk Assessments for the Section 3
Registration Action on Leafy Greens (Subgroup 4A) Except Spinach, Head
and Stem Brassica (Subgroup 5A), Cilantro, Swiss Chard, Pineapple,
Papaya, Black Sapote, Canistel, Mamey Sapote, Mango, Sapodilla, Star
Apple, and Hops.

PC Code:  128879	DP Num:  361544

Decision Nos.:  383407	Registration No.:  400-518

Petition Nos.:  7E7258 and 7E7286	Regulatory Action:  Section 3
Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  68694-11-1

MRID No.:  NA	40 CFR:  §180.476

REVIEWER:	W. Cutchin, Chemist

Alternative Risk Integration Assessment (ARIA) Team

Risk Integration, Minor Use, and Emergency Response Branch (RIMUERB)

Registration Division (RD; 7505P)

THROUGH:	D. Hrdy, Biologist

		N. Dodd, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (HED; 7509P)

TO:		S. Jackson, Risk Manager

RIMUERB/RD (7505P)

Executive Summary

CID™, Version 2.14 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 requested Section 3 registrations.

The acute dietary exposure assessments used tolerance-level residues and
100% crop treated (CT) for all registered and proposed uses.  The
assessment incorporated triflumizole residues in drinking water
directly, using the maximum concentration (1-in-10-year annual peak) for
surface water generated by the Pesticide Root Zone Model-Exposure
Analysis Modeling System (PRZM-EXAMS) model.  These assessments conclude
that the acute dietary (food + drinking water) exposure estimates (95th
percentile) are below the Agency’s level of concern (<100% acute
population adjusted dose; aPAD) for the general U.S. population (26%
aPAD) and all population subgroups (children 1-2 years old at 40% aPAD
and females 13-49 years old at 67% aPAD). 

The chronic dietary (food + drinking water) exposure assessment used
anticipated residues (ARs) from average field trial residues for apple,
grape, pear, cherry, cucurbit, strawberry, milk commodities, leafy
greens (subgroup 4A) except spinach, head and stem Brassica (subgroup
5A), cilantro, Swiss chard, pineapple, papaya, black sapote, canistel,
mamey sapote, mango, sapodilla, star apple and hops.  For all other
commodities, the assessment used current and proposed tolerances.  The
assessment used % CT information for apples, cantaloupes, cherries,
cucumbers, grapes, hazelnuts (filberts), honeydew melons, pears,
pumpkins, squash, strawberries, and watermelons, but used 100% CT
information for all other registered and proposed uses.  Drinking water
was incorporated directly into the dietary assessment using the mean
concentration (1-in-10-year annual mean) for surface water generated by
the PRZM-EXAMS model.  The chronic assessment concludes that the chronic
dietary exposure estimates are below the Agency’s level of concern
(<100% chronic (c) PAD) for the general U.S. population (26% cPAD) and
all population subgroups.  The most highly exposed population subgroup
is children 1-2 years old at 44% cPAD.

I.  Introduction

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  For acute and chronic assessments, the risk is
expressed as a percentage of a maximum acceptable dose (i.e., the dose
which HED has concluded will result in no unreasonable adverse health
effects).  This dose is referred to as the population adjusted dose
(PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL,
e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, the Agency is concerned when
estimated dietary risk exceeds 100% of the PAD.  The Agency 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 triflumizole was conducted
for Brassica leafy greens, crop subgroup 5B (J. Tomerlin, 1/8/08, DP
Num: 341964).

II.  Residue Information

Registered and Proposed Tolerances: Permanent tolerances are established
under 40 CFR §180.476(a) for the combined residues of triflumizole and
its metabolites containing the 4-chloro-2-trifluoromethylaniline moiety,
calculated as the parent compound, in/on apples, cherries, filberts,
grapes, pears, strawberries, and cucurbit vegetables.  Permanent
tolerances have also been established under 40 CFR §180.476(a) for the
same residue of concern in/on milk; eggs; meat, fat, and meat byproducts
(mbyp) of cattle, goats, hogs, horses, and sheep; and in/on meat, fat,
and mbyp of poultry.  Time-limited tolerances in conjunction with
Section 18 Emergency Exemptions have been established under 40 CFR
§180.476(b) for the combined residues of triflumizole and its
metabolites containing the 4-chloro-2-trifluoromethylaniline moiety,
calculated as the parent compound, in/on broccoli, Chinese (Napa)
cabbage, collards, coriander, dandelion, kale, kohlrabi, mustard greens,
parsley, Swiss chard, and turnip greens.

ARIA has recommended for Section 3 registrations and tolerances on:  

Brassica, head and stem, subgroup 5A	8.0 ppm

Leafy greens subgroup 4A, except spinach	35 ppm

Coriander, leaves	35 ppm

Swiss chard	18 ppm

Pineapple	4.0 ppm

Papaya	2.5 ppm

Sapote, black	2.5 ppm

Canistel	2.5 ppm

Sapote, mamey	2.5 ppm

Mango	2.5 ppm

Sapodilla	2.5 ppm

Star apple	2.5 ppm

Hop, dried cones	50 ppm

Since there are no longer any poultry or swine feed items of regulatory
interest, the current tolerances on eggs; poultry fat, meat, and meat
byproducts; and hog fat, meat and meat byproducts should all be deleted.
 Based on the previously reviewed cattle feeding study and the revised
dietary burden, tolerances are required for meat byproducts and fat of
cattle, sheep, goat, and horse, but below established levels. 
Specifically, ARIA recommends lowering the present fat tolerance levels
from 0.5 ppm to 0.10 ppm, and also lowering the meat byproduct tolerance
levels from 0.5 ppm to 0.20 ppm (PP#s 7E7258 and 7E7286, DP Num: 354063,
W. Cutchin, 10/1/08).  All other established livestock tolerances should
be removed from 40 CFR § 180.476(a)(2).

Cattle, fat	0.10 ppm

Cattle, meat byproducts	0.20 ppm

Goat, fat	0.10 ppm

Goat, meat byproducts	0.20 ppm

Horse, fat	0.10 ppm

Horse, meat byproducts	0.20 ppm

Sheep, fat	0.10 ppm

Sheep, meat byproducts	0.20 ppm

When the permanent tolerances recommended in the registration action
become final, the time-limited tolerances for the following RACs,
established under Section 18 Emergency Exemptions [40 CFR §180.476(b)],
may be removed:  broccoli (1.0 ppm); cabbage, Chinese, napa (20 ppm),
coriander leaves (20 ppm), dandelion, leaves (7.0 ppm); kohlrabi (20
ppm); parsley leaves (20 ppm); and Swiss chard (7.0 ppm).

Nature of the Residue: The nature of the residue in fruit is adequately
understood based on acceptable metabolism data on apples, cucumbers,
grapes, and pears.  The residues of concern include the parent compound,
triflumizole and its metabolites (free and conjugates) containing the
4-chloro-2-trifluoromethylaniline moiety (calculated as triflumizole). 
In a meeting on 2/26/02, the HED Metabolism Assessment Review Committee
(MARC) concluded that there was no need to revisit the residues of
concern in primary crops (DP Num: 280869, J. Tyler, 3/13/02).  The MARC
concurred with the current tolerance expressions for plants as stated in
40 CFR §180.476.

The nature of the residue in livestock is adequately understood based on
acceptable metabolism data on lactating goats and poultry.  The residues
of concern were determined to be the combined residues of triflumizole,
the metabolite 4-chloro-2-hydroxy-6-trifluoromethylaniline sulfate, and
other metabolites containing the 4-chloro-2-trifluoromethylaniline
moiety, calculated as the parent compound.  In a meeting on 2/26/02, the
HED MARC concluded that there was no need to revisit the residues of
concern in livestock (DP Num: 280869, J. Tyler, 3/13/02).  The MARC
concurred with the current tolerance expressions for livestock as stated
in 40 CFR §180.476.  There are no livestock feed commodities associated
with the proposed tolerances, so the proposed registration does not have
an impact on residues in edible livestock tissues.

Residue Data used for Acute, Chronic, and/or Cancer Assessments:

Anticipated Residues: Tolerance-level residues were used for all
registered and proposed commodities in the acute assessment.  For the
chronic assessment, anticipated residues (ARs) calculated as the mean
value from field trial data were used for apple, grape, pear, cherry,
most cucurbit vegetables, strawberry, leafy greens (subgroup 4A) except
spinach, head and stem Brassica (subgroup 5A), cilantro, Swiss chard,
pineapple, papaya, canistel, mamey sapote, mango, and hops.  See Table 1
for further information; additional information can be found in
Attachment 5 of the HED risk assessment (DP Num: 280865, J. Tyler,
4/9/02) and the ARIA residue chemistry chapter (PP#: 7E7258 and 7E7286,
DP Num: 344463 and 346779, W. Cutchin, 10/1/08).

TABLE 1:  Summary of Residue Values Used in the Dietary (Food + Drinking
Water) Risk Assessments for Triflumizole

COMMODITY	ACUTE ASSESSMENT	CHRONIC ASSESSMENT

	Tolerance

(ppm)	Processing

Factors	Tolerance

(ppm)	AR1

(ppm)	%CT2	Processing

Factors

Established Crop Commodities

Apples	0.5	Juice – 1.0

Sauce & Dried– DEEM	NU3	0.14	20	Juice – 1.0

Sauce & Dried– DEEM

Brassica leafy greens9	40	NA	40	NC	NR	NA

Cherries	1.5	DEEM	NU	0.66	15	DEEM

Grapes	2.5	Juice – 1.0

Raisin, Leaves and Wine/Sherry – DEEM	NU	0.55	5	Juice – 1.0

Raisin, Leaves and Wine/Sherry – DEEM

Hazelnuts	0.05	DEEM	0.05	NC	15	DEEM

Muskmelons5	0.5	NA	NU	0.17	106	NA

Pears	0.5	DEEM	NU	0.23	40	DEEM

Strawberries	2.0	NA	NU	0.53	NR	NA

Summer Squash7	0.5	NA	NU	0.14	NR	NA

Established Livestock Commodities

Fat8	0.10	NA	0.10	NC	NA	NA

Meat byproducts (Mbyp)8	0.20	NA	0.20	NC	NA	NA

Proposed Commodities

Brassica, head and stem, subgroup 5A	8.0	NA	8.0	Cabbage 0.74

Broccoli 1.79 	NR	NA

Leafy greens subgroup 4A, except spinach	35	NA	35	Head Lettuce 2.97

Leaf Lettuce 11.1	NR	NA

Coriander, leaves	35	NA	35	11.1	NR	NA

Swiss chard	18	NA	18	5.48	NR	NA

Pineapple	4.0	Juice - 1.0

Dried - DEEM	4.0	2.17	NR	Juice - 1.0

Dried - DEEM

Papaya	2.5	NA	2.5	0.63	NR	NA

Sapote, black	2.5	NA	2.5	0.63	NR	NA

Canistel	2.5	NA	2.5	0.63	NR	NA

Sapote, mamey	2.5	NA	2.5	0.63	NR	NA

Mango	2.5	NA	2.5	0.63	NR	NA

Sapodilla	2.5	NA	2.5	0.63	NR	NA

Star apple	2.5	NA	2.5	0.63	NR	NA

Hop, dried cones	50	NA	50	14.4	NR	NA

1 Anticipated Residue: calculated as the mean value from field trial
data

2 Percent Crop Treated: Taken from A. Grube, 12/28/07, memo titled
“Screening Level Usage Analysis (SLUA) Report Package in Support of
Registration for the Fungicide Triflumizole (PC 128879)”, no DP Num
listed.

3 NA – Not available; NC – Not calculated; NR – Not Reported; NU
– Not Used

4 Translated to Chinese waxgourd, balsam pear, and bitter melon

5 Translated to citron melon, casabas, crenshaws, cantaloupe, honeydew
melons, persian melon, winter melon, watermelon.  

6 Percent crop treated of 10% was used for cantaloupes and percent crop
treated of 15% used for honeydew melons.  100% CT was assumed for all
other melons.

7 Translated to christophine, okra/Chinese gourd, pumpkin, summer and
winter squash

8 Of cattle, goats, horses, and sheep

9 Field trial data from mustard greens residue trials were translated to
Brassica leafy greens, crop subgroup 5B, including the commodities:
Broccoli raab, collards, kale, rape greens, and turnip greens.  Although
a tolerance of 20 ppm was requested by the petitioner, ARIA recommended
a tolerance of 40 ppm (DP Nums: 338653 and 341963, J. Tomerlin,
12/7/07,) based upon calculations performed according to “NAFTA
Guidance Document for Guidance for Setting Pesticide Maximum Residue
Limits Based on Field Trial Data”, Regulatory Proposal PRO2005-04
published jointly by the U. S. Environmental Protection Agency’s
Office of Pesticide Programs and Health Canada’s Pest Management
Regulatory Agency.

 3/16/89); therefore, the DEEM™ default concentration factors for
these processed commodities were reduced to 1.  The dietary risk
assessments used DEEM™ default concentration factors for all other
processed commodities.

Percent Crop Treated: Updated percent crop treated (%CT) information was
provided by the Office of Pesticide Program’s (OPP’s) Biological and
Economic Analysis Division (BEAD) for apples, cantaloupes, cherries,
cucumbers, grapes, hazelnuts (filberts), honeydew melons, pears,
pumpkins, squash, strawberries, and watermelons (A. Grube, 12/28/07,
memo titled “Screening Level Usage Analysis (SLUA) Report Package in
Support of Registration for the Fungicide Triflumizole (PC 128879)”,
no DP Num listed).  The %CT estimates from this SLUA are summarized in
Table 2.

Table 2:  Percent Crop Treated Estimates for Triflumizole

COMMODITY	MEAN PERCENT

CROP TREATED	MAXIMUM PERCENT

CROP TREATED

Apples	20	35

Cantaloupes	10	15

Cherries	15	20

Cucumbers	< 1	< 2.5

Cucumbers, pickles	5	5

Grapes	5	10

Hazelnuts (Filberts)	15	40

Honeydew melons	15	25

Pears	40	55

Pumpkins	5	10

Squash	< 1	< 2.5

Strawberries	15	25

Watermelons	5	5

For the acute dietary risk assessment, residues were assumed to be
from100% CT of registered and proposed commodities.  For the chronic
assessment, the mean %CT information was used only for the specific
commodities listed.  For example, the estimate of 15% CT for honeydew
melons was not used for casaba melons, for which 100% CT was assumed.  

Although separate %CT estimates are available for cucumbers and pickle
cucumbers, the DEEM dietary database does not differentiate consumption
estimates for cucumber pickles.  Therefore, the chronic dietary risk
assessment used the higher value of 5% for all cucumbers.  The chronic
risk assessment assumed that 1% of squash were treated, effectively
ignoring the “<” symbol.

  Drinking Water Data

Drinking Water Considerations: The Environmental Fate and Effects
Division (EFED) provided revised Tier II drinking water estimated
drinking water concentrations (EDWCs) to include the degradates
containing the 4-chloro-2-trifluoromethylaniline moiety (MARC; DP Num:
280869, J. Tyler, 3/13/02): “Triflumizole Drinking Water Assessment in
Support of New Use Registration Action for Brassica, Leafy Greens,
Subgroup 5B, Leafy Greens Subgroup 4A (except Spinach), Papayas, and
Hops,” 10/3/07, I. L. Maher, T. Nguyen, and T. Bailey, DP Nums: 338654
and 344465.  Water residues were incorporated in the DEEM-FCID directly
into the food categories “water, direct, all sources” and “water,
indirect, all sources.”  

The EDWCs derived for total residues of parent and degradates containing
the 4-chloro-2-trifluoromethylaniline moiety were updated to account for
an anaerobic aquatic metabolism study submitted by the registrant.  The
Screening Concentration in Ground Water (SCI-GROW) and Pesticide Root
Zone Model-Exposure Analysis Modeling System (PRZM-EXAMS) models were
used to derive the ground and surface water EDWCs, respectively. 
Although the proposed use patterns for Brassica vegetables were
evaluated, maximum EDWC values were obtained using the maximum
application scenario (0.5 lb ai/A/application and 6 applications/year)
for cherries.  Therefore, the drinking water EDWCs were derived for
cherries.  The ground water EDWC was 3.11 ppb.  The acute EDWC of 37.4
ppb was taken from the 1-in-10 year annual maximum concentration
calculated by PRZM-EXAMS.  Likewise, the chronic EDWC of 15.8 ppb was
taken from the 1-in-10 year annual mean concentration calculated by
PRZM-EXAMS.  Consequently, the dietary (food + water) risk assessments
used residue values of 0.037 and 0.016 ppm for the acute and non-cancer
chronic assessments, respectively.

Additional information regarding 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/ .  

IV.  DEEM-FCID™ Program and Consumption Information

Triflumizole acute and chronic dietary exposure assessments were
conducted using the Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database DEEM-FCID™, Version 2.14 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 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.

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.

V.  Toxicological Information

With the exception of the chronic endpoint, the risk assessment team
adopted toxicity endpoints used in previous risk assessments (DP Num:
325681, J. Tyler, 3/1/06; DP Num: 306463, J. Tyler, M. Dow and R.
Mitkus, 1/28/05).  The chronic RfD is based on a LOAEL of 3.5 mg/kg/day
based on liver toxicity (eosinophilic foci in male rats and fatty
vacuolation and inflammation and necrosis in female rats) in combined
chronic toxicity/carcinogenicity study in rats (DP Num: 361545, J.
Redden, 3/4/09).

The former Hazard Identification Assessment Review Committee (HIARC)
recommended that an acute neurotoxicity study and a subchronic
neurotoxicity study be submitted in order to better characterize the
neurological effects seen in the rat and mouse acute oral, the rat acute
inhalation and the rat chronic studies.  The former FQPA Safety Factor
Committee (SFC) recommended a UFDB of 3x be applied to the acute and
chronic RfDs in order to account for any uncertainty due to the lack of
these two neurotoxicity studies (TXR NO. 0050571, D. Nixon, 3/17/02). 
Since that time, acceptable acute and subchronic rat neurotoxicity and
subchronic rat neurotoxicity studies (GLN 870.6200) have been submitted
and reviewed; therefore, the risk assessment team determined that the 3x
UFDB should be removed from the acute and chronic RfDs.  In addition,
the FQPA SFC recommended the FQPA Safety Factor (SF) be reduced to 1x. 
Based upon a re-evaluation of the quality of the exposure and hazard
data, the risk assessment team recommended that the FQPA SF remain at
1x.  The recommendation is based on the following:

The toxicity database is complete for FQPA assessment;

There was no quantitative or qualitative evidence of increased
susceptibility in the rabbit fetuses following in utero exposure or the
rat following pre- and post-natal exposure in the rat reproduction
study;

There was evidence of qualitative susceptibility in the developmental
rat study; however, there are no residual uncertainties, and the use of
the developmental NOAEL and the endpoint for the aRfD for females 13-49
would be protective with respect to the pre-natal toxicity following an
acute dietary exposure;

There is no evidence of increased quantitative or qualitative
susceptibility in the rat developmental neurotoxicity study;

The acute dietary food exposure assessment utilizes existing and
proposed tolerance level residues and 100% CT for all commodities.  By
using these screening-level assessments, actual exposures/risks will not
be underestimated;

The chronic dietary food exposure assessment utilizes anticipated
residues (ARs) and percent crop treated (% CT) data summarized by
OPP’s BEAD for several existing uses.  For all proposed uses,
tolerance-level residues and 100% CT are assumed.  The chronic
assessment is somewhat refined and based on reliable data and will not
underestimate exposure/risk;

The dietary drinking water assessment utilizes water concentration
values generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations which will not likely be exceeded;

There are no registered or proposed uses of triflumizole that would
result in residential exposure.

However, in a memo from J. Redden (DP Num: 361545, 3/4/09) ARIA agrees
with the removal of the FQPA safety factor decision as to acute risk but
believes a 3x FQPA safety factor is needed for the chronic RfD because
it is derived from the use of a LOAEL established in the combined
chronic toxicity/carcinogenicity study in rats.  A 3x FQPA Safety Factor
for use of LOAEL instead of a NOAEL (as opposed to a 10x) is viewed to
be adequate because: 

The most sensitive endpoint in the target organ (liver) for this class
of compounds (conazole fungicide) is used for assessing chronic risk.

 There is low concern for the observed effects since the lesions did not
progress into malignancy.

The available data dose do not show this chemical to be a potent
toxicant since clear NOAELs were established following dietary
administrations in all the other studies such as the two-generation
reproduction (3.5 m/k/d), subchronic rat (15.3 m/k/d) and mouse (33.1
m/k/d); chronic dog study (10 m/k/d) and the carcinogenicity (16.2
m/k/d) studies. 

The extrapolated NOAEL of 1.2 mg/k/d (3.5/3 = 1.2) is supported by a
comparable NOAEL (2.5 m/k/d) used for deriving the chronic RfD for a
structurally-related chemical (imazalil). 

Based on these weight-of-evidence considerations, the Agency is
confident that a 3x FQPA Safety Factor is adequate to address the
concerns for the lack of a NOAEL in the critical study and that the
chronic RfD would not underestimate dietary risk from chronic exposure
to triflumizole.  

Based on the proposed use pattern, the toxicology database for
triflumizole is adequate for risk assessment.  However, an
immunotoxicity study in rats is required under the current (revised)
Part 158 Toxicology Data requirements (40 CFR).  This study was not
submitted to the Agency in support of the proposed registration for
products containing triflumizole.  Therefore, registration of
triflumizole should be made conditional pending receipt of an acceptable
immunotoxicity study.  

The toxicity endpoints used to evaluate acute and chronic dietary risk
are summarized in Table 3.

Table 3.  Summary of Toxicological Doses and Endpoints for Triflumizole
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
= 25 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x	Acute RfD = 0.25 mg/kg/day	Acute Neurotoxicity – Rat

LOAEL = 100 mg/kg/day based on FOB findings (neuromuscular impairment)
and decreased locomotor activity.

Acute Dietary

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

UFH= 10x

FQPA SF= 1x	Acute RfD = 0.1 mg/kg/day	Developmental Toxicity – Rat

LOAEL = 35 mg/kg/day based upon decreased numbers of viable fetuses,
increased dead or resorbed fetuses, increased numbers of late
resorptions, decreased fetal body weight, and increased incidences of
cervical ribs.

Chronic Dietary (All Populations)	LOAEL= 3.5 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 3x	Chronic RfD = 0.035

mg/kg/day

cPAD = 0.0117 mg/kg/day	Combined Chronic Toxicity/Carcinog. Study -  Rat

Based on liver toxicity (eosinophilic foci in male rats and fatty
vacuolation and inflammation and necrosis in female rats).

Cancer	Classification: “Evidence for non-carcinogenicity for Humans”
based on adequate studies in two animal species.

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 (intraspecies).  UFH =
potential variation in sensitivity among members of the human population
(interspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  UFS = use
of a short-term study for long-term risk assessment.  UFDB = to account
for the absence of key data (i.e., lack of a critical study).  FQPA SF =
FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c =
chronic).  RfD = reference dose.  MOE = margin of exposure.  LOC = level
of concern.  N/A = not applicable.

VI.  Results/Discussion 

As stated above, for acute and chronic assessments, the Agency is
concerned when dietary risk exceeds 100% of the appropriate PAD.  The
DEEM-FCID™ analyses estimate the dietary exposure of the U.S.
population and various population subgroups.  The results reported in
Table 4 are for the general U.S. Population, all infants (<1 year old),
children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49,
adults 20-49, and adults 50+ years.  With respect to carcinogenicity,
triflumizole has been classified as “Evidence for non-carcinogenicity
for Humans;” therefore, a triflumizole cancer risk assessment was not
performed.

Results of Acute Dietary (Food + Drinking Water) Exposure Analysis:

The results of the acute dietary exposure analysis are reported in Table
4.  The acute dietary (food + drinking water) exposure assessments used
tolerance-level residues and 100% CT for all registered and proposed
uses.  Drinking water was incorporated directly in the dietary
assessment using the maximum concentration for surface water generated
by the PRZM/EXAMS model.  These assessments conclude that the acute
dietary exposure estimates (95th percentile) are below the Agency’s
level of concern (<100% aPAD) for the general U.S. population (26% aPAD)
and all population subgroups.  Exposure was equivalent to 40% of the
aPAD for the most highly exposed population subgroup (children 1-2 years
old) and 67% of the aPAD for females 13-49 years old.

Results of Chronic Dietary (Food + Drinking Water) Exposure Analysis:

The results of the chronic dietary exposure analysis are reported in
Table 4.  The chronic dietary exposure assessment used ARs from average
field trial residues for apple, grape, pear, cherry, most cucurbit
vegetables, strawberry, leafy greens (subgroup 4A) except spinach, head
and stem Brassica (subgroup 5A), cilantro, Swiss chard, pineapple,
papaya, canistel, mamey sapote, mango, and hops, and registered and
proposed tolerances for all other commodities.  The assessment used % CT
information for apples, cantaloupes, cherries, cucumbers, grapes,
hazelnuts (filberts), honeydew melons, pears, pumpkins, squash,
strawberries, and watermelons; and 100% CT for all other registered and
proposed uses.  The chronic dietary (food + drinking water) risk
assessment was conducted for the general U.S. population and various
population subgroups.  Drinking water was incorporated directly into the
dietary assessment using the chronic (annual average) concentration for
surface water generated by the PRAM/EXAMS model.  This assessment
concludes that the chronic dietary exposure estimates are below the
Agency’s level of concern (<100% cPAD) for the general U.S. population
(26% cPAD) and all population subgroups.  The most highly exposed
population subgroup is children 1-2 years old at 44% cPAD.

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

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	0.064679	26	0.003082	26	N/A	N/A

All Infants (< 1 year old)	0.039008	16	0.002318	20

Children 1-2 years old	0.099522	40	0.005132	44

Children 3-5 years old	0.086530	35	0.004747	41

Children 6-12 years old	0.067118	27	0.002720	23

Youth 13-19 years old	0.054418	22	0.002714	23

Adults 20-49 years old	0.064733	26	0.002743	23

Adults 50+ years old	0.059468	24	0.003453	30

Females 13-49 years old	0.067180	67	0.002729	23

	VII.  Characterization of Inputs/Outputs

Adequate data are available for the determination of tolerance levels,
as discussed in the applicable residue chemistry memos.  The
triflumizole ARs used in the chronic dietary exposure assessment (listed
in Table 1) are based on field trial data submitted by the registrant to
support tolerances.  Field trial residue data are generally considered
by the Agency as an upper-end or a worst case scenario of possible
residues, because field trials require the highest rates of application
and shortest preharvest interval (PHI).  

Field trial data were translated from some commodities to other
commodities in the same crop group.  Residue data from cucumbers were
translated to Chinese waxgourd, balsam pear, and bitter melon; residue
data from muskmelons were translated to citron melon, casabas,
crenshaws, cantaloupe, honeydew melons, persian melons, winter melon,
and watermelon; residue data from mustard greens were translated to
Brassica leafy greens, crop subgroup 5B: broccoli raab, Chinese (Napa)
cabbage, collards, kale, rape greens, and turnip greens; residue data
from leaf lettuce were translated to coriander and the leafy greens
subgroup 4A, except spinach and head lettuce; and residue data from
papaya were translated to black sapote, canistel, mamey sapote, mango,
sapodilla, and star apple.  In all cases, data was translated from a
representative commodity only to other commodities in the same crop
group.  This practice is consistent with Agency data usage policy and
practice.

The use of 100%CT for most of the commodities that could be treated with
triflumizole is a conservative measure that overestimates dietary
exposure and risk from triflumizole residues.

Regarding the level of refinement of the assessments, the acute dietary
assessment is unrefined in that it assumes that 100% of eligible
commodities contain tolerance-level residues of triflumizole. 
Therefore, the acute assessment provides a conservative estimate of
acute dietary risk to triflumizole which is protective of public health.
 The chronic dietary assessment is partially refined in that it uses
anticipated residues for numerous commodities, as well as %CT data for
several other commodities.  However, the chronic assessment does assume
that the other commodities contain tolerance level residues. 
Consequently, the chronic assessment provides a reasonably conservative
assessment of potential risk to residues of triflumizole in the diet.

	VIII.  Conclusions

  The DEEM-FCID™ analysis estimates the dietary exposure of the U.S.
population and 26 population subgroups.  Table 4 summarizes dietary
exposure and risk for the U.S. Population, all infants (<1 year old),
children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49,
males 20-49, and adults 50+ years.

The unrefined acute dietary (food + drinking water) assessment used
tolerance-level residues in 100% of eligible commodities.  Drinking
water was incorporated directly in the assessment.  These assessments
conclude that estimated exposure at the 95th percentile is below the
Agency’s level of concern for all population subgroups evaluated. 
Estimated exposure was equivalent to 26% and 40% of the aPAD for the
general U.S. population and children 1-2 years old, respectively. 
Estimated exposure for females 13-49 years old was equivalent to 67% of
the aPAD.

The chronic dietary (food + drinking water) exposure assessment used ARs
for some commodities and tolerance values for the remainder.  The
assessment used 100% CT for most commodities, but did use estimates of
%CT for several crops.  Drinking water was incorporated directly into
the assessment.  Exposure estimates for all population subgroups are
below the Agency’s level of concern (<100% chronic cPAD).  Estimated
exposure was equivalent to 26% and 44% of the cPAD for the general U.S.
population and children 1-2 years old (the most highly exposed
subgroup), respectively.

IX.  List of Attachments

1: Acute Food + Drinking Water Residue Input file.

2: Acute Results file, except Females 13-49

3. Acute Results file, Females 13-49

4: Chronic Food + Drinking Water Residue Input file.

5: Chronic Results file.

6: Triflumizole SLUA



ATTACHMENT 1:  Residue File for Acute Dietary (Food + Drinking Water) 

U.S. Environmental Protection Agency                                
Ver. 2.02

DEEM-FCID Acute analysis for TRIFLUMIZOLE

Residue file name: G:\working\Triflum\128879a.R98

Analysis Date 09-22-2008             Residue file dated:
09-22-2008/11:12:29/8

Reference dose (aRfD) = 0.25 mg/kg bw/day

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

04010050 4A   Amaranth, leafy                   35.000000   1.000  1.000

11000070 11   Apple, fruit with peel             0.500000   1.000  1.000

11000080 11   Apple, peeled fruit                0.500000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood       0.500000   1.000  1.000

11000090 11   Apple, dried                       0.500000   8.000  1.000

11000091 11   Apple, dried-babyfood              0.500000   8.000  1.000

11000100 11   Apple, juice                       0.500000   1.000  1.000

11000101 11   Apple, juice-babyfood              0.500000   1.000  1.000

11000110 11   Apple, sauce                       0.500000   1.000  1.000

11000111 11   Apple, sauce-babyfood              0.500000   1.000  1.000

04010180 4A   Arugula                           35.000000   1.000  1.000

09020210 9B   Balsam pear                        0.500000   1.000  1.000

21000460 M    Beef, meat byproducts              0.200000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.200000   1.000  1.000

21000470 M    Beef, fat                          0.100000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.100000   1.000  1.000

05010610 5A   Broccoli                           8.000000   1.000  1.000

05010611 5A   Broccoli-babyfood                  8.000000   1.000  1.000

05010620 5A   Broccoli, Chinese                  8.000000   1.000  1.000

05020630 5B   Broccoli raab                     40.000000   1.000  1.000

05010640 5A   Brussels sprouts                   8.000000   1.000  1.000

05010690 5A   Cabbage                            8.000000   1.000  1.000

05020700 5B   Cabbage, Chinese, bok choy        40.000000   1.000  1.000

05010710 5A   Cabbage, Chinese, napa             8.000000   1.000  1.000

05010720 5A   Cabbage, Chinese, mustard          8.000000   1.000  1.000

95000740 O    Canistel                           2.500000   1.000  1.000

09010750 9A   Cantaloupe                         0.500000   1.000  1.000

09010800 9A   Casaba                             0.500000   1.000  1.000

05010830 5A   Cauliflower                        8.000000   1.000  1.000

09020880 9B   Chayote, fruit                     0.500000   1.000  1.000

12000900 12   Cherry                             1.500000   1.000  1.000

12000901 12   Cherry-babyfood                    1.500000   1.000  1.000

12000910 12   Cherry, juice                      1.500000   1.500  1.000

12000911 12   Cherry, juice-babyfood             1.500000   1.500  1.000

09021020 9B   Chinese waxgourd                   0.500000   1.000  1.000

04011040 4A   Chrysanthemum, garland            35.000000   1.000  1.000

05021170 5B   Collards                          40.000000   1.000  1.000

19011180 19A  Coriander, leaves                 35.000000   1.000  1.000

19011181 19A  Coriander, leaves-babyfood        35.000000   1.000  1.000

04011330 4A   Cress, garden                     35.000000   1.000  1.000

04011340 4A   Cress, upland                     35.000000   1.000  1.000

09021350 9B   Cucumber                           0.500000   1.000  1.000

04011380 4A   Dandelion, leaves                 35.000000   1.000  1.000

04011500 4A   Endive                            35.000000   1.000  1.000

14001550 14   Filbert                            0.050000   1.000  1.000

14001560 14   Filbert, oil                       0.050000   1.000  1.000

23001700 M    Goat, meat byproducts              0.200000   1.000  1.000

23001710 M    Goat, fat                          0.100000   1.000  1.000

95001750 O    Grape                              2.500000   1.000  1.000

95001760 O    Grape, juice                       2.500000   1.000  1.000

95001761 O    Grape, juice-babyfood              2.500000   1.000  1.000

95001770 O    Grape, leaves                      2.500000   1.000  1.000

95001780 O    Grape, raisin                      2.500000   4.300  1.000

95001790 O    Grape, wine and sherry             2.500000   1.000  1.000

09011870 9A   Honeydew melon                     0.500000   1.000  1.000

95001880 O    Hop                               50.000000   1.000  1.000

05021940 5B   Kale                              40.000000   1.000  1.000

05011960 5A   Kohlrabi                           8.000000   1.000  1.000

04012040 4A   Lettuce, head                     35.000000   1.000  1.000

04012050 4A   Lettuce, leaf                     35.000000   1.000  1.000

95002150 O    Mango                              2.500000   1.000  1.000

95002151 O    Mango-babyfood                     2.500000   1.000  1.000

95002160 O    Mango, dried                       2.500000   1.000  1.000

95002170 O    Mango, juice                       2.500000   1.000  1.000

95002171 O    Mango, juice-babyfood              2.500000   1.000  1.000

05022290 5B   Mustard greens                    40.000000   1.000  1.000

95002450 O    Papaya                             2.500000   1.000  1.000

95002451 O    Papaya-babyfood                    2.500000   1.000  1.000

95002460 O    Papaya, dried                      2.500000   1.800  1.000

95002470 O    Papaya, juice                      2.500000   1.500  1.000

04012480 4A   Parsley, leaves                   35.000000   1.000  1.000

19012490 19A  Parsley, dried leaves             35.000000   1.000  1.000

19012491 19A  Parsley, dried leaves-babyfood    35.000000   1.000  1.000

11002660 11   Pear                               0.500000   1.000  1.000

11002661 11   Pear-babyfood                      0.500000   1.000  1.000

11002670 11   Pear, dried                        0.500000   6.250  1.000

11002680 11   Pear, juice                        0.500000   1.000  1.000

11002681 11   Pear, juice-babyfood               0.500000   1.000  1.000

95002790 O    Pineapple                          4.000000   1.000  1.000

95002791 O    Pineapple-babyfood                 4.000000   1.000  1.000

95002800 O    Pineapple, dried                   4.000000   5.000  1.000

95002810 O    Pineapple, juice                   4.000000   1.000  1.000

95002811 O    Pineapple, juice-babyfood          4.000000   1.000  1.000

09023080 9B   Pumpkin                            0.500000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.500000   1.000  1.000

04013130 4A   Radicchio                         35.000000   1.000  1.000

05023180 5B   Rape greens                       40.000000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.200000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.200000   1.000  1.000

26003410 M    Sheep, fat                         0.100000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.100000   1.000  1.000

09023560 9B   Squash, summer                     0.500000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.500000   1.000  1.000

09023570 9B   Squash, winter                     0.500000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.500000   1.000  1.000

95003590 O    Strawberry                         2.000000   1.000  1.000

95003591 O    Strawberry-babyfood                2.000000   1.000  1.000

95003600 O    Strawberry, juice                  2.000000   1.000  1.000

95003601 O    Strawberry, juice-babyfood         2.000000   1.000  1.000

04023670 4B   Swiss chard                       18.000000   1.000  1.000

05023890 5B   Turnip, greens                    40.000000   1.000  1.000

86010000 O    Water, direct, all sources         0.037000   1.000  1.000

86020000 O    Water, indirect, all sources       0.037000   1.000  1.000

09013990 9A   Watermelon                         0.500000   1.000  1.000

09014000 9A   Watermelon, juice                  0.500000   1.000  1.000

ATTACHMENT 2:  Acute Dietary (Food + Water) Exposure Analysis, Except
Females 

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: 128879a.R98                         Adjustment factor #2
NOT used.

Analysis Date: 09-22-2008/11:19:09    Residue file dated:
09-22-2008/11:12:29/8

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th
Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure  
% aRfD 

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

U.S. Population:

                    0.064679    25.87    0.120094    48.04    0.222048  
 88.82 

All infants:

                    0.039008    15.60    0.083833    33.53    0.237666  
 95.07 

Children 1-2 yrs:

                    0.099522    39.81    0.189346    75.74    0.402569  
161.03 

Children 3-5 yrs:

                    0.086530    34.61    0.171124    68.45    0.458449  
183.38 

Children 6-12 yrs:

                    0.067118    26.85    0.118731    47.49    0.241756  
 96.70 

Youth 13-19 yrs:

                    0.054418    21.77    0.127038    50.82    0.200944  
 80.38 

Adults 20-49 yrs:

                    0.064733    25.89    0.115985    46.39    0.212482  
 84.99 

Adults 50+ yrs:

                    0.059468    23.79    0.109666    43.87    0.179040  
 71.62 

Note: The aPAD is 0.1 mg/kg bw/day for females 13-49 and 0.25 mg/kg
bw/day for all other population groups.  ATTACHMENT 3:  Acute Dietary
(Food + Water) Exposure Analysis, Females

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: 128879a.R98                         Adjustment factor #2
NOT used.

Analysis Date: 09-22-2008/11:18:04    Residue file dated:
09-22-2008/11:12:29/8

Acute Pop Adjusted Dose (aPAD) varies with population; see individual
reports

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th
Percentile

                   Exposure   % aPAD    Exposure   % aPAD    Exposure  
% aPAD 

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

Females 13-49 yrs:

                    0.067180    67.18    0.118034   118.03    0.212362  
212.36 

Note: The aPAD is 0.1 mg/kg bw/day for females 13-49 and 0.25 mg/kg
bw/day for all other population groups.  ATTACHMENT 4: Residue File for
Chronic Dietary (Food + Drinking Water)

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for TRIFLUMIZOLE                      
1994-98 data

Residue file: G:\working\Triflum\128879cAR.R98                 Adjust.
#2 used

Analysis Date 01-21-2009             Residue file dated:
01-21-2009/09:58:25/8

Reference dose (RfD) = 0.0117 mg/kg bw/day

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

04010050 4A   Amaranth, leafy                   11.100000   1.000     
1.000   

11000070 11   Apple, fruit with peel             0.140000   1.000     
0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000080 11   Apple, peeled fruit                0.140000   1.000     
0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000081 11   Apple, peeled fruit-babyfood       0.140000   1.000     
0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000090 11   Apple, dried                       0.140000   8.000     
0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000091 11   Apple, dried-babyfood              0.140000   8.000     
0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000100 11   Apple, juice                       0.140000   1.000     
0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000101 11   Apple, juice-babyfood              0.140000   1.000     
0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000110 11   Apple, sauce                       0.140000   1.000     
0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000111 11   Apple, sauce-babyfood              0.140000   1.000     
0.200   Per up

  Full comment: Per updated SLUA of Dec 07

04010180 4A   Arugula                           11.100000   1.000     
1.000   

09020210 9B   Balsam pear                        0.500000   1.000     
1.000   

21000460 M    Beef, meat byproducts              0.200000   1.000     
1.000   

21000461 M    Beef, meat byproducts-babyfood     0.200000   1.000     
1.000   

21000470 M    Beef, fat                          0.100000   1.000     
1.000   

21000471 M    Beef,fat-babyfood                  0.100000   1.000     
1.000   

05010610 5A   Broccoli                           1.790000   1.000     
1.000   

05010611 5A   Broccoli-babyfood                  1.790000   1.000     
1.000   

05010620 5A   Broccoli, Chinese                  1.790000   1.000     
1.000   

05020630 5B   Broccoli raab                     40.000000   1.000     
1.000   

05010640 5A   Brussels sprouts                   1.790000   1.000     
1.000   

05010690 5A   Cabbage                            0.740000   1.000     
1.000   

05020700 5B   Cabbage, Chinese, bok choy        40.000000   1.000     
1.000   

05010710 5A   Cabbage, Chinese, napa             0.740000   1.000     
1.000   

05010720 5A   Cabbage, Chinese, mustard          0.740000   1.000     
1.000   

95000740 O    Canistel                           0.630000   1.000     
1.000   

09010750 9A   Cantaloupe                         0.170000   1.000     
0.100   Per up

  Full comment: Per updated SLUA of Dec 07

09010800 9A   Casaba                             0.170000   1.000     
1.000   

05010830 5A   Cauliflower                        1.790000   1.000     
1.000   

09020880 9B   Chayote, fruit                     0.500000   1.000     
1.000   

12000900 12   Cherry                             0.660000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

12000901 12   Cherry-babyfood                    0.660000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

12000910 12   Cherry, juice                      0.660000   1.500     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

12000911 12   Cherry, juice-babyfood             0.660000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

09021020 9B   Chinese waxgourd                   0.500000   1.000     
1.000   

04011040 4A   Chrysanthemum, garland            11.100000   1.000     
1.000   

05021170 5B   Collards                          40.000000   1.000     
1.000   

19011180 19A  Coriander, leaves                 11.100000   1.000     
1.000   

19011181 19A  Coriander, leaves-babyfood        11.100000   1.000     
1.000   

04011330 4A   Cress, garden                     11.100000   1.000     
1.000   

04011340 4A   Cress, upland                     11.100000   1.000     
1.000   

09021350 9B   Cucumber                           0.130000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

04011380 4A   Dandelion, leaves                 11.100000   1.000     
1.000   

04011500 4A   Endive                            11.100000   1.000     
1.000   

14001550 14   Filbert                            0.050000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

14001560 14   Filbert, oil                       0.050000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

23001700 M    Goat, meat byproducts              0.200000   1.000     
1.000   

23001710 M    Goat, fat                          0.100000   1.000     
1.000   

95001750 O    Grape                              0.550000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001760 O    Grape, juice                       0.550000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001761 O    Grape, juice-babyfood              0.550000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001770 O    Grape, leaves                      0.550000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001780 O    Grape, raisin                      0.550000   4.300     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001790 O    Grape, wine and sherry             0.550000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

09011870 9A   Honeydew melon                     0.170000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

95001880 O    Hop                               14.400000   1.000     
1.000   

05021940 5B   Kale                              40.000000   1.000     
1.000   

05011960 5A   Kohlrabi                           1.790000   1.000     
1.000   

04012040 4A   Lettuce, head                      2.970000   1.000     
1.000   

04012050 4A   Lettuce, leaf                     11.100000   1.000     
1.000   

95002150 O    Mango                              0.630000   1.000     
1.000   

95002151 O    Mango-babyfood                     0.630000   1.000     
1.000   

95002160 O    Mango, dried                       0.630000   1.000     
1.000   

95002170 O    Mango, juice                       0.630000   1.000     
1.000   

95002171 O    Mango, juice-babyfood              0.630000   1.000     
1.000   

05022290 5B   Mustard greens                    40.000000   1.000     
1.000   

95002450 O    Papaya                             0.630000   1.000     
1.000   

95002451 O    Papaya-babyfood                    0.630000   1.000     
1.000   

95002460 O    Papaya, dried                      0.630000   1.800     
1.000   

95002470 O    Papaya, juice                      0.630000   1.500     
1.000   

04012480 4A   Parsley, leaves                   11.100000   1.000     
1.000   

19012490 19A  Parsley, dried leaves             35.000000   1.000     
1.000   

19012491 19A  Parsley, dried leaves-babyfood    35.000000   1.000     
1.000   

11002660 11   Pear                               0.230000   1.000     
0.400   Per up

  Full comment: Per updated SLUA of Dec 07

11002661 11   Pear-babyfood                      0.230000   1.000     
0.400   Per up

  Full comment: Per updated SLUA of Dec 07

11002670 11   Pear, dried                        0.230000   6.250     
0.400   Per up

  Full comment: Per updated SLUA of Dec 07

11002680 11   Pear, juice                        0.230000   1.000     
0.400   Per up

  Full comment: Per updated SLUA of Dec 07

11002681 11   Pear, juice-babyfood               0.230000   1.000     
0.400   Per up

  Full comment: Per updated SLUA of Dec 07

95002790 O    Pineapple                          2.170000   1.000     
1.000   

95002791 O    Pineapple-babyfood                 2.170000   1.000     
1.000   

95002800 O    Pineapple, dried                   2.170000   5.000     
1.000   

95002810 O    Pineapple, juice                   2.170000   1.000     
1.000   

95002811 O    Pineapple, juice-babyfood          2.170000   1.000     
1.000   

09023080 9B   Pumpkin                            0.140000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

09023090 9B   Pumpkin, seed                      0.140000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

04013130 4A   Radicchio                         11.100000   1.000     
1.000   

05023180 5B   Rape greens                       40.000000   1.000     
1.000   

95003330 O    Sapote, Mamey                      0.630000   1.000     
1.000   

26003400 M    Sheep, meat byproducts             0.200000   1.000     
1.000   

26003410 M    Sheep, fat                         0.100000   1.000     
1.000   

26003411 M    Sheep, fat-babyfood                0.100000   1.000     
1.000   

09023560 9B   Squash, summer                     0.140000   1.000     
0.010   Per up

  Full comment: Per updated SLUA of Dec 07

09023561 9B   Squash, summer-babyfood            0.140000   1.000     
0.010   Per up

  Full comment: Per updated SLUA of Dec 07

09023570 9B   Squash, winter                     0.140000   1.000     
0.010   Per up

  Full comment: Per updated SLUA of Dec 07

09023571 9B   Squash, winter-babyfood            0.140000   1.000     
0.010   Per up

  Full comment: Per updated SLUA of Dec 07

95003590 O    Strawberry                         0.530000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

95003591 O    Strawberry-babyfood                0.530000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

95003600 O    Strawberry, juice                  0.530000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

95003601 O    Strawberry, juice-babyfood         0.530000   1.000     
0.150   Per up

  Full comment: Per updated SLUA of Dec 07

04023670 4B   Swiss chard                        5.480000   1.000     
1.000   

05023890 5B   Turnip, greens                    40.000000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.016000   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.016000   1.000     
1.000   

09013990 9A   Watermelon                         0.170000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

09014000 9A   Watermelon, juice                  0.170000   1.000     
0.050   Per up

  Full comment: Per updated SLUA of Dec 07

ATTACHMENT 5: Chronic Dietary (Food + Water) Exposure Analysis

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: G:\working\Triflum\128879cAR.R98

                                                     Adjustment factor
#2 used.

Analysis Date 01-21-2009/09:59:05     Residue file dated:
01-21-2009/09:58:25/8

Reference dose (RfD, Chronic) = .0117 mg/kg bw/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.003082               
26.3%

U.S. Population (spring season)             0.003069               
26.2%

U.S. Population (summer season)             0.003159               
27.0%

U.S. Population (autumn season)             0.003228               
27.6%

U.S. Population (winter season)             0.002851               
24.4%

Northeast region                            0.002943               
25.2%

Midwest region                              0.002678               
22.9%

Southern region                             0.003440               
29.4%

Western region                              0.003070               
26.2%

Hispanics                                   0.002164               
18.5%

Non-hispanic whites                         0.002334               
19.9%

Non-hispanic blacks                         0.006927               
59.2%

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††††††††㘵㔮ഥ䄍汬椠普湡獴⠠‼‱敹牡 †
†††††††††〠〮㈰ㄳ‸†††††††ㄠ⸹┸
不牵楳杮椠普湡獴††††††††††††††〠〮
〰㈹‶††††††††⸷┹



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Non-nursing infants                         0.002846               
24.3%

Children 1-6  yrs                           0.004680               
40.0%

Children 7-12 yrs                           0.002567               
21.9%

Females 13-19 (not preg or nursing)         0.002372               
20.3%

Females 20+ (not preg or nursing)           0.003129               
26.7%

Females 13-50 yrs                           0.002707               
23.1%

Females 13+ (preg/not nursing)              0.002254               
19.3%

Females 13+ (nursing)                       0.002300               
19.7%

Males 13-19 yrs                             0.003033               
25.9%

Males 20+ yrs                               0.002889               
24.7%

Seniors 55+                                 0.003541               
30.3%

Children 1-2 yrs                            0.005132               
43.9%

Children 3-5 yrs                            0.004747               
40.6%

Children 6-12 yrs                           0.002720               
23.2%

Youth 13-19 yrs                             0.002714               
23.2%

Adults 20-49 yrs                            0.002743               
23.4%

Adults 50+ yrs                              0.003453               
29.5%

Females 13-49 yrs                           0.002729               
23.3%

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

ATTACHMENT 6.  Triflumizole SLUA

Triflumizole	Dietary Exposure and Risk Assessment	DP Number: 354065

PC Code: 128879

________________________________________________________________________
______________

Page   PAGE  23  of   NUMPAGES  23