UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: 22-AUG-2013 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Triflumizole. Acute and Chronic Dietary (Food and Drinking Water) Exposure 

and Risk Assessments for Greenhouse Uses on Tomato and Cucumber; 

Translations of Apple and Pear to Pome Fruit Group 11-10, Grape to Crop 

Subgroup 13-07F, and Strawberry to Crop Subgroup 13-07G, Except Cranberry. 

PC Code: 128879 

Decision No.: 472282 

Petition No.: 2E8119 

DP Barcode: D413699 

Registration Nos.: 400-436, -518, -521 

Regulatory Action: Section 3 Registration 

Risk Assessment Type: Dietary Case No.: NA 

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

MRID No.: NA 40 CFR: §180.476 

REVIEWER: 

THROUGH: 

TO: 

William H. Donovan, Ph.D., Chemist W ~ 'JJ ... -D~ Risk Assessment Branch V 

Health Effects Division (HED) (7509P) 

NancyDodd,Chemist . Ideliz Negr6n-Encamaci~m, Ph.D.~ Chemist / cJ79 ---- Dietary Exposure Science Advisory Council (D AC) HED (7509P) 

Andrew Ertman/Barbara Madden, RM 05 

Registration Division (RD) (7505P) 

Executive Summary 

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments 

were conducted using the Dietary Exposure Evaluation Model software with the Food 

Commodity Intake Database (DEEM-FCID) Version 3.16. This software incorporates 2003-

2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National 

Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The 

analyses were conducted in support of a human health risk assessment for the proposed Section 

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Triflumizole (128879) Dietary Exposure and Risk Assessment 0413699 

3 uses of triflumizole on greenhouse cucumber and tomato, Crop Group 11-10 [Po me fruit], 

Crop Subgroup 13-07F [Small fruit vine climbing, except fuzzy kiwifruit subgroup], and Crop 

Subgroup 13-07G, except cranberry [Low-growing berry subgroup, except cranberry]. This 

memo was reviewed by two members of the DESAC, per the current DESAC SOP. 

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

A conservative acute dietary assessment was conducted using tolerance-level residues, 100% 

crop treated assumptions, and modeled water estimates. At the 951h percentile of exposure, the 

estimated risk is :S66% of the acute population adjusted dose (aPAD) for the U.S. population and 

all population subgroups. 

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

A partially refined chronic dietary assessment was conducted using average residues from 

supervised field trials, percent crop treated information, and modeled water estimates. The 

estimated risk is :S39% of the chronic population adjusted dose (cPAD) for the U.S. population 

and all population subgroups. 

Cancer Dietary Exposure and Characterization 

Triflumizole is classified as "Not likely to be Carcinogenic to Humans" based on the absence of 

significant tumor increases in two adequate rodent carcinogenicity studies. Therefore, a cancer 

dietary exposure analysis is not required. 

I. Introduction 

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute 

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose 

(i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the 

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

factors. 

For acute and chronic exposures, HED is concerned when estimated dietary risk exceeds 100% 

of the PAD. References which discuss the acute and chronic risk assessments in more detail are 

available on the EPA/pesticides web site: "Available Information on Assessing Exposure from 

Pesticides, A User's Guide," 21-JUN-2000, web link: http://www.epa.gov/fedrgstr/EPAPEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG-1999). 

The most recent dietary risk assessment for triflumizole was conducted by W. Donovan 

(D397935, 28-MAR-2012). 

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II. Residue Information

Established and Recommended Tolerances: Permanent tolerances for residues of triflumizole, 

including its metabolites and degradates are established under 40 CFR §180.476(a)(1) for plants 

and under 40 CFR §180.476(a)(2) for livestock commodities. Compliance with the tolerance 

levels under 40 CFR §180.476(a)(1) is to be determined by measuring only the parent and its 

metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as the parent 

compound, in/on the crops listed in Table 1. Compliance with the tolerance levels under 40 CFR 

§180.476(a)(2) is to be determined by measuring only the parent, 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/on the fat, meat, and meat 

byproducts of cattle, goats, hogs, horses, poultry, and sheep; milk, , and eggs. However, based 

on the cattle feeding study and revisions from the Table 1 Feedstuffs (June 2008), livestock 

tolerances are appropriate only for meat byproducts and fat of cattle, goats, horses, and sheep 

(D354063, W. Cutchin, 10/1/08). Consequently, the present analyses were based on the 

recommended tolerances listed in Table 1 instead of the established tolerances for livestock 

commodities.

Table 1. Tolerance Summary for Triflumizole.

Commodity Established

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Comments

Correct Commodity 

Definition

Plant Commodities § 180.476(a)(1)

Apple 0.5 -- In group 11-10

Apple, dry pomace 2.0 -- Not a regulated feedstuff

Apple, wet pomace 2.0 -- No residue concentration

Brassica,head and stem, subgroup 5A 8.0 8.0

Brassica, leafy greens, subgroup 5B 40 40

Canistel 2.5 2.5

Cherry, sweet 1.5 1.5

Cherry, tart 1.5 1.5

Cilantro, leaves 35 35 Coriander, leaves

Fruit, pome, group 11-10 -- 0.5 Extrapolated from apple, 

pear

Fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13-07F

-- 2.5 Extrapolated from grape

Berry, low growing, subgroup 13-

07G, except cranberry

-- 2.0 Extrapolated from 

strawberry

Grape 2.5 -- In group 13-07F

Grape, dried pomace 15 --

Grape, raisin, waste 10 -- Not a regulated feedstuff

Grape, wet pomace 15 --

Hazelnut 0.05 0.05

Hop, dried cones 50 50

Leafy greens subgroup 4A, except 

spinach

35 35

Mango 2.5 2.5

Papaya 2.5 2.5

Pear 0.5 -- In group 11-10

Pineapple 4.0 4.0
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Table 1. Tolerance Summary for Triflumizole.

Commodity Established

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Comments

Correct Commodity 

Definition

Pome fruit, group 11-10 -- 0.5

Sapodilla 2.5 2.5

Sapote, black 2.5 2.5

Sapote, mamey 2.5 2.5

Star apple 2.5 2.5

Strawberry 2.0 -- In subgroup 13-07G

Swiss chard 18 18

Tomato -- 1.5 Greenhouse only

Turnip, greens 40 40

Vegetable, cucurbit, group 9 0.5 0.8 Increased level due to 

greenhouse cucumber 

field trial data

Livestock Commodities § 180.476(a)(2)

Cattle, fat 0.5 0.1

Tolerances for fat, meat 

and meat byproducts of 

hog and poultry; meat of 

cattle, goat, horse, and 

sheep; milk, and egg 

should be deleted.

Cattle, meat 0.05 --

Cattle, meat byproduct 0.5 0.2

Egg 0.05 --

Goat, fat 0.5 0.1

Goat, meat 0.05 --

Goat, meat byproduct 0.5 0.2

Hog, fat 0.5 --

Hog, meat 0.05 --

Hog, meat byproduct 0.5 --

Horse, fat 0.5 0.1

Horse, meat 0.05 --

Horse, meat byproduct 0.5 0.2

Milk 0.05 --

Poultry, fat 0.05 --

Poultry, meat 0.05 --

Poultry, meat byproduct 0.1 --

Sheep, fat 0.5 0.1

Sheep, meat 0.05 --

Sheep, meat byproduct 0.5 0.2

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. Tolerances are required for meat byproducts and fat of cattle, 

sheep, goat, and horse, but below established levels. Specifically, the established fat tolerance 

levels should be lowered from 0.5 ppm to 0.10 ppm, and the meat byproduct tolerance levels 

should be lowered from 0.5 ppm to 0.20 ppm (D354063, W. Cutchin, 10/1/08). All other 

established livestock tolerances should be removed from 40 CFR § 180.476(a)(2).

Nature of the Residue: The nature of the residue in plants 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) (D280869, J. Tyler, 

3/13/02).
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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 (D280869, J. Tyler, 3/13/02). 

Residue Data used for Acute and Chronic Assessments:

Anticipated Residues: Tolerance-level residues were used for all registered 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, 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 2

for a summary of the input values used in the present analysis. 

TABLE 2: Summary of Residue Values Used in the Dietary (Food + Drinking Water) Risk Assessments for 

Triflumizole

COMMODITY1

ACUTE ASSESSMENT CHRONIC ASSESSMENT

Tolerance

(ppm)

Processing

Factors AR2

(ppm)

%CT3 Processing

Factors

Established Crop Commodities

Leafy greens subgroup 

4A, except spinach 35 NA4 Head Lettuce 2.97Leaf Lettuce 11.1 NR NA

Brassica, head and 

stem, subgroup 5A 8.0 NA Cabbage 0.74Broccoli 1.79 NR NA

Brassica leafy greens

subgroup 5B5 40 NA 7.72 NR NA

Muskmelons, subgroup

9A6 0.8 NA 0.17 10/158 NA

Summer squash, 

subgroup 9B6 0.8 NA 0.14 5 NA

Pome fruit, group 11-10 0.5 See Apple and Pear

Small vine climbing 

fruit except fuzzy 

kiwifruit, subgroup 13-

07F

2.5 See Grape

Low growing berry, 

subgroup 13-07G, 

except cranberry

2.0 See Strawberry

Cucumber

(Greenhouse)7 0.8 NA 0.25 2.5 NA

Apple90.5

Juice – 1.0

Sauce – 1.0

Dried – 8.0

0.14 25

Juice – 1.0

Sauce – 1.0

Dried – 8.0

Pear90.5 Dried – 6.25 0.23 45 Dried – 6.25

Grape92.5 Juice – 1.0

Raisin – 1.0 0.55 5

Juice – 1.0

Raisin – 1.0

Cherry

10 1.5 Juice – 1.5 0.66 25 Juice – 1.5

Coriander, leaves 35 NA 11.1 NR NA
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TABLE 2: Summary of Residue Values Used in the Dietary (Food + Drinking Water) Risk Assessments for 

Triflumizole

COMMODITY1

ACUTE ASSESSMENT CHRONIC ASSESSMENT

Tolerance

(ppm)

Processing

Factors AR2

(ppm)

%CT3 Processing

Factors

Hazelnuts (Filberts)11 0.05 NA 0.05 5 NA

Hop, dried cones 50 NA 14.4 NR NA

Strawberry

13 2.0 NA 0.53 25 NA

Swiss chard 18 NA 5.48 NR NA

Pineapple 4.0 Juice – 1.0

Dried – 5.0 2.17 NR Juice – 1.0Dried – 5.0

Papaya 2.5 Juice – 1.5

Dried – 1.8 0.63 NR Juice – 1.5Dried – 1.8

Sapote, black 2.5 NA 0.63 NR NA

Canistel 2.5 NA 0.63 NR NA

Sapote, mamey 2.5 NA 0.63 NR NA

Mango 2.5 NA 0.63 NR NA

Sapodilla 2.5 NA 0.63 NR NA

Star apple 2.5 NA 0.63 NR NA

Tomato (Greenhouse)12 1.5 NA 0.59 NR NA

Recommended Livestock Commodities

Fat14 0.10 NA 0.10 NA NA

Meat byproducts 

(Mbyp)14 0.20 NA 0.20 NA NA

1

 Unless otherwise indicated, anticipated residue values were from: D346779, W. Cutchin, 01-OCT-2008.

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

3

Percent Crop Treated from BEAD SLUA

4 NA – Not Available; NC – Not Calculated; NR – Not Reported

5 Subgroup 5B: D338653, J.R. Tomerlin, 07-DEC-2007.

6 D271003, J. Tyler, 11-MAR-2002.

7 MRID 48998101. 

8

Percent crop treated of 10% was used for cantaloupes and percent crop treated of 30% used for honeydew melons. 

100% CT was assumed for all other melons except watermelon (5%).

9

 Apple, pear, and grape: MRID#s 407520-06 thru 407520-08; and 400185-07 thru 400185-09) were previously 

reviewed in the HED memos dated 3/16/89 (Memo, S. Malak; DEB#s 4277 and 4278) and 3/13/87 (Memo, R. 

Loranger). 

10 Cherry: D242429, J. Tyler, 30-APR-2001.

11

Filbert: D312293, J. Tyler, 18-MAY-2005.

12 MRID 48998102. 

13

Strawberry: D274589, J. Tyler, 11-MAR-2002.

14 Of cattle, goats, horses, and sheep.

No crop field trial data were submitted for cilantro, which is not currently a member of subgroup 

4A. However, the proposed update to subgroup 4A includes fresh leaves for both parsley and 

cilantro (12/14/2011 ChemSAC Minutes). Because the commodity definition for parsley has 

been determined to be equivalent to cilantro (Reviewer’s Guide, B. Schneider, 14-JUN-2002), 

and parsley is a member of subgroup 4A, data for head and leaf lettuce are adequate to support

tolerances on parsley and cilantro leaves (D346779, W. Cutchin, 01-OCT-2008). Note that the 

preferred commodity terminology for cilantro is coriander. 
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DEEM does not include a default processing factor for parsley, dried leaves. To account for the 

potentially higher residues in parsley, dried leaves, tolerance level residues for subgroup 4A 

were used for this commodity. 

Processing Factors: The combined triflumizole residues did not concentrate in pineapple 

process residue and juice (D346779, W. Cutchin, 01-OCT-2008). There is no evidence that 

triflumizole residues concentrate in raisins, grape juice, apple juice, and apple sauce (DEB Nos. 

4277 and 7278, S. Malak, 3/16/89); therefore, the DEEMTM default concentration factors for 

these processed commodities were reduced to 1. The dietary risk assessments used DEEMTM 

default concentration factors for all other processed commodities, except tomato. No tomato 

processed commodities were included in the assessments since triflumizole use is limited to 

greenhouse tomato varieties, and these are not processed for economic reasons.

The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, 

and 2010. In general, pesticide residues would not be expected to be found in fish unless the 

pesticide bioaccumulates or has an aquatic use. To determine whether or not residues are present 

in fish, HED now routinely checks PDP monitoring data regardless of the pesticide’s uses and 

physicochemical properties. In 2008, PDP analyzed 552 catfish samples for triflumizole, 

reporting no detections. As a result, residues in fish were not included in the assessment.

III. Percent Crop Treated Information

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 in a Screening Level Usage Analysis (SLUA) dated 30-JAN2013. Although BEAD provided maximum and average %CT information, only the average 

%CT values were utilized in the dietary exposure analysis. 

The following average percent crop treated estimates (30-JAN-2013 Triflumizole SLUA) were 

used in the chronic dietary risk assessments for the following crops that are registered for 

triflumizole: apple: 25%; cantaloupe: 10%; cherry: 25%; cucumber: 2.5%; filbert: 5%; grape: 

5%; honeydew: 15%; pear: 45%; pumpkin: 5%; squash: 5%; strawberry: 25%; and watermelon: 

5%.

IV. Drinking Water Data

The Environmental Fate and Effects Division (EFED) provided 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): “Tier II Drinking 

Water Assessment to Establish Tolerances of Triflumizole on Greenhouse Vegetables (Cucumber 

and Tomato), Pome Fruit Subgroup 11-10, Small Fruit Vine Climbing Subgroup 13-07F and Low 

Growing Berry Subgroup 13-07G (excluding Cranberry)” 5/20/13, C.M. Koper, S. Sankula, and E. 

Odenkirchen, D407680. Water residues were incorporated in DEEM-FCID directly into the food 

categories “water, direct, all sources” and “water, indirect, all sources.” 

For groundwater, SCI-GROW and PRZM-GW simulations were executed. PRZM-GW
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concentration estimates were less than those generated from SCI-GROW. For surface water, the

Pesticide Root Zone Model-Exposure Analysis Modeling System (PRZM-EXAMS) model was

used to derive the surface water EDWC. Maximum acute and chronic EDWC values were 

obtained using the maximum application scenarios for ornamentals and cherries, respectively. 

The ground water EDWC was 3.1 ppb. The acute EDWC of 98 ppb was taken from the 1-in-10 

year annual maximum concentration calculated by PRZM-EXAMS. Likewise, the chronic

EDWC of 22 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 0.098 and 0.022 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: http://www.epa.gov/oppefed1/models/water/. 

V. DEEM-FCIDTM Program and Consumption Information

Triflumizole acute and chronic dietary exposure assessments were conducted using the DEEMFCID, Version 3.16, which incorporates 2003-2008 food consumption data from USDA’s 

NHANES/WWEIA. The 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. However, for acute 

exposure assessment, consumption data are retained as individual consumption events. Based on 

analysis of the 2003-2008 WWEIA 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 50-99

years old.

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (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 an acute exposure assessment, 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 
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exposure and risk are reported for analyses performed at all levels of refinement. However, for 

deterministic assessments, any significant differences in user vs. per capita exposure and risk are 

specifically identified and noted in the risk assessment.

VI. Toxicological Information

The toxicity endpoints were from the most recent human-health risk assessment (D393221, S. 

Tadayon et. al., 5/2/12), and 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 = 0.012

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: “Not likely to be Carcinogenic to Humans” based on the absence 

of significant tumor increases in two adequate rodent carcinogenicity studies. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and 

used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human 

exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = 

uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 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.

Separate PODs were selected for females of child-bearing age (13-49) and the general population

including infants and children. For females 13-49, a developmental endpoint was selected with a 

NOAEL = 10 mg/kg/day and a LOAEL = 35 mg/kg/day. For the general population, the POD 

was the NOAEL = 25 mg/kg/day and a LOAEL = 100 mg/kg/day at which functional 
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observational battery (FOB) findings (neuromuscular impairment) and decreased locomotor 

activity were observed following a single exposure. An uncertainty factor of 100x (10x for 

interspecies extrapolation and 10x intraspecies variation) was applied to derive the acute 

Reference Doses (RfD) for these population groups. The chronic dietary endpoint is based on 

liver toxicity observed at 3.5 mg/kg/day, the lowest dose tested in the combined chronic

toxicity/carcinogenicity study in rats; a NOAEL was not established. An uncertainty factor of 

300x (10x for interspecies extrapolation, 10x intraspecies extrapolation and 3x for the use of a 

LOAEL (UFL)) was used to derive the chronic RfD. 

The Agency has determined that a 3x for the use of a LOAEL (as opposed to the default 10x) is 

adequate based on the following weight of evidence considerations: 

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 observed lesions (eosinophilic 

foci in male rats and fatty vacuolation and inflammation and necrosis in female rats) did 

not progress into malignancy. 

The available data do not show this chemical to be a potent toxicant following short- and 

long-term dietary exposure since clear NOAELs were established in all the other studies 

such as the reproduction (3.5 mg/kg/day), subchronic rat (15.3 mg/kg/day), subchronic 

mouse (33.1 mg/kg/day), chronic dog 10 mg/kg/day) and the mouse carcinogenicity (16.2 

mg/kg/day) studies.

The extrapolated NOAEL of 1.2 mg/kg/day (3.5/3 = 1.2) is supported by a comparable 

NOAEL (2.5 mg/kg/day) used for deriving the chronic RfD for a structurally-related 

chemical (imazalil).

VII. 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-FCIDTM 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 50-99 years old. With 

respect to carcinogenicity, triflumizole has been classified as “not likely to be carcinogenic to 

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 assessment used tolerance-level residues and 100% CT for all 

crops. Drinking water was incorporated directly in the dietary assessment using the maximum 

concentration for surface water generated by the PRZM/EXAMS model. This assessment 

indicated that the acute dietary exposure estimates (at the 95th percentile) are below the Agency’s 
Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

___________________________________________________________________________________________

Page 11 of 20

level of concern (<100% of the aPAD) for the general U.S. population (25% of the aPAD) and 

all population subgroups. Exposure was equivalent to 66% of the aPAD for the most highly 

exposed population subgroup (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. The assessment used % CT 

information where available, and 100% CT for all other crops. 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 

PRZM/EXAMS model. This assessment concludes that the chronic dietary exposure estimates 

are below the Agency’s level of concern (<100% of the cPAD) for the general U.S. population 

(21% of the cPAD) and all population subgroups. The most highly exposed population subgroup 

is children 1-2 years old at 39% of the 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 0.063555 25 0.002571 21

N/A N/A

All Infants (< 1 year old) 0.046533 19 0.002625 22

Children 1-2 years old 0.099738 40 0.004641 39

Children 3-5 years old 0.090227 36 0.003741 31

Children 6-12 years old 0.058912 24 0.002281 19

Youth 13-19 years old 0.048310 19 0.001728 14

Adults 20-49 years old 0.062830 25 0.002563 21

Adults 50-99 years old 0.062045 25 0.002602 22

Females 13-49 years old 0.066279 66 0.002531 21

VIII. Characterization of Inputs/Outputs

The triflumizole ARs used in the chronic dietary exposure assessment (listed in Table 2) 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 rate of application and shortest preharvest 

interval (PHI). 
Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

___________________________________________________________________________________________

Page 12 of 20

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 and %CT data where available. 

Consequently, the chronic assessment provides a reasonably conservative assessment of potential 

risk to residues of triflumizole in the diet.

Should further refinements become necessary, utilization of the maximum %CT estimates 

provided by BEAD is recommended for the acute assessment. Also, residues of triflumizole

have been analyzed by the Pesticide Data Program (PDP) in many crops as summarized in the 

2008 & 2009 PDP reports. Strawberry samples had the highest triflumizole residues (0.41 ppm)

and the highest percentage of detections (10%). However, no samples exceeded the established 

tolerance levels. Most crops had residues of triflumizole below the LOQ of 0.06 ppm in all 

samples.

IX. Conclusions

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 acute exposure at the 95th percentile is below the 

Agency’s level of concern for all population subgroups evaluated. 

The chronic dietary (food + drinking water) exposure assessment used ARs and %CT 

information as available. Drinking water was incorporated directly into the assessment. Chronic 

exposure estimates for all population subgroups are below the Agency’s level of concern. 

HED is confident that the assessments provided in this memorandum do not underestimate risk 

to the general U.S. population or any population subgroup.

X. List of Attachments

Attachment 1. Acute Residue Input File

Attachment 2. Acute Results File

Attachment 3. Chronic Residue Input File

Attachment 4. Chronic Results File

Attachment 5. Triflumizole SLUA

ATTACHMENT 1: Residue File for Acute Dietary (Food + Drinking Water) 
Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

___________________________________________________________________________________________

Page 13 of 20

Filename: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 3.16\128879A.R08

Chemical: Triflumizole

RfD(Chronic): .012 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .25 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 08-20-2013/08:02:24 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0401005000 4A Amaranth, leafy 35.000000 1.000 1.000 

0401018000 4A Arugula 35.000000 1.000 1.000 

0401104000 4A Chrysanthemum, garland 35.000000 1.000 1.000 

0401133000 4A Cress, garden 35.000000 1.000 1.000 

0401134000 4A Cress, upland 35.000000 1.000 1.000 

0401138000 4A Dandelion, leaves 35.000000 1.000 1.000 

0401150000 4A Endive 35.000000 1.000 1.000 

0401204000 4A Lettuce, head 35.000000 1.000 1.000 

0401205000 4A Lettuce, leaf 35.000000 1.000 1.000 

0401248000 4A Parsley, leaves 35.000000 1.000 1.000 

0401313000 4A Radicchio 35.000000 1.000 1.000 

0402367000 4B Swiss chard 18.000000 1.000 1.000 

0501061000 5A Broccoli 8.000000 1.000 1.000 

0501061001 5A Broccoli-babyfood 8.000000 1.000 1.000 

0501062000 5A Broccoli, Chinese 8.000000 1.000 1.000 

0501064000 5A Brussels sprouts 8.000000 1.000 1.000 

0501069000 5A Cabbage 8.000000 1.000 1.000 

0501071000 5A Cabbage, Chinese, napa 8.000000 1.000 1.000 

0501072000 5A Cabbage, Chinese, mustard 8.000000 1.000 1.000 

0501083000 5A Cauliflower 8.000000 1.000 1.000 

0501196000 5A Kohlrabi 8.000000 1.000 1.000 

0502063000 5B Broccoli raab 40.000000 1.000 1.000 

0502070000 5B Cabbage, Chinese, bok choy 40.000000 1.000 1.000 

0502117000 5B Collards 40.000000 1.000 1.000 

0502194000 5B Kale 40.000000 1.000 1.000 

0502229000 5B Mustard greens 40.000000 1.000 1.000 

0502318000 5B Rape greens 40.000000 1.000 1.000 

0502389000 5B Turnip, greens 40.000000 1.000 1.000 

0801374000 8A Tomatillo 1.500000 1.000 1.000 

0801375000 8A Tomato 1.500000 1.000 1.000 

0801380000 8A Tomato, Tree 1.500000 1.000 1.000 

0901075000 9A Cantaloupe 0.800000 1.000 1.000 

0901187000 9A Honeydew melon 0.800000 1.000 1.000 

0901399000 9A Watermelon 0.800000 1.000 1.000 

0901400000 9A Watermelon, juice 0.800000 1.000 1.000 

0902021000 9B Balsam pear 0.800000 1.000 1.000 

0902088000 9B Chayote, fruit 0.800000 1.000 1.000 

0902102000 9B Chinese waxgourd 0.800000 1.000 1.000 

0902135000 9B Cucumber 0.800000 1.000 1.000 

0902308000 9B Pumpkin 0.800000 1.000 1.000 

0902309000 9B Pumpkin, seed 0.800000 1.000 1.000 

0902356000 9B Squash, summer 0.800000 1.000 1.000 

0902356001 9B Squash, summer-babyfood 0.800000 1.000 1.000 

0902357000 9B Squash, winter 0.800000 1.000 1.000 

0902357001 9B Squash, winter-babyfood 0.800000 1.000 1.000 

1100007000 11 Apple, fruit with peel 0.500000 1.000 1.000 

1100008000 11 Apple, peeled fruit 0.500000 1.000 1.000 

1100008001 11 Apple, peeled fruit-babyfood 0.500000 1.000 1.000 

1100009000 11 Apple, dried 0.500000 8.000 1.000 

1100009001 11 Apple, dried-babyfood 0.500000 8.000 1.000 

1100010000 11 Apple, juice 0.500000 1.000 1.000 

1100010001 11 Apple, juice-babyfood 0.500000 1.000 1.000 

1100011000 11 Apple, sauce 0.500000 1.000 1.000 

1100011001 11 Apple, sauce-babyfood 0.500000 1.000 1.000 

1100129000 11 Crabapple 0.500000 1.000 1.000 

1100210000 11 Loquat 0.500000 1.000 1.000 

1100266000 11 Pear 0.500000 1.000 1.000 

1100266001 11 Pear-babyfood 0.500000 1.000 1.000 

1100267000 11 Pear, dried 0.500000 6.250 1.000 

1100268000 11 Pear, juice 0.500000 1.000 1.000 
Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

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Page 14 of 20

1100268001 11 Pear, juice-babyfood 0.500000 1.000 1.000 

1100310000 11 Quince 0.500000 1.000 1.000 

1201090000 12A Cherry 1.500000 1.000 1.000 

1201090001 12A Cherry-babyfood 1.500000 1.000 1.000 

1201091000 12A Cherry, juice 1.500000 1.500 1.000 

1201091001 12A Cherry, juice-babyfood 1.500000 1.500 1.000 

1302057000 13B Blueberry 2.000000 1.000 1.000 

1302057001 13B Blueberry-babyfood 2.000000 1.000 1.000 

1302174000 13B Gooseberry 2.500000 1.000 1.000 

1304175000 13D Grape 2.500000 1.000 1.000 

1304176000 13D Grape, juice 2.500000 1.000 1.000 

1304176001 13D Grape, juice-babyfood 2.500000 1.000 1.000 

1304179000 13D Grape, wine and sherry 2.500000 1.000 1.000 

1307359000 13G Strawberry 2.000000 1.000 1.000 

1307359001 13G Strawberry-babyfood 2.000000 1.000 1.000 

1307360000 13G Strawberry, juice 2.000000 1.000 1.000 

1307360001 13G Strawberry, juice-babyfood 2.000000 1.000 1.000 

1400155000 14 Hazelnut 0.050000 1.000 1.000 

1400156000 14 Hazelnut, oil 0.050000 1.000 1.000 

1901118000 19A Cilantro, leaves 35.000000 1.000 1.000 

1901118001 19A Cilantro, leaves-babyfood 35.000000 1.000 1.000 

1901249000 19A Parsley, dried leaves 35.000000 1.000 1.000 

1901249001 19A Parsley, dried leaves-babyfood 35.000000 1.000 1.000 

3100046000 31 Beef, meat byproducts 0.200000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.200000 1.000 1.000 

3100047000 31 Beef, fat 0.100000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.100000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.200000 1.000 1.000 

3200171000 32 Goat, fat 0.100000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.200000 1.000 1.000 

3500341000 35 Sheep, fat 0.100000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.100000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.098000 1.000 1.000 D40768

 Full comment: D407680, 5/20/13

8602000000 86B Water, indirect, all sources 0.098000 1.000 1.000 D40768

 Full comment: D407680, 5/20/13

9500074000 O Canistel 2.500000 1.000 1.000 

9500177000 O Grape, leaves 2.500000 1.000 1.000 

9500178000 O Grape, raisin 2.500000 1.000 1.000 

9500188000 O Hop 50.000000 1.000 1.000 

9500215000 O Mango 2.500000 1.000 1.000 

9500215001 O Mango-babyfood 2.500000 1.000 1.000 

9500216000 O Mango, dried 2.500000 1.000 1.000 

9500217000 O Mango, juice 2.500000 1.000 1.000 

9500217001 O Mango, juice-babyfood 2.500000 1.000 1.000 

9500245000 O Papaya 2.500000 1.000 1.000 

9500245001 O Papaya-babyfood 2.500000 1.000 1.000 

9500246000 O Papaya, dried 2.500000 1.800 1.000 

9500247000 O Papaya, juice 2.500000 1.500 1.000 

9500279000 O Pineapple 4.000000 1.000 1.000 

9500279001 O Pineapple-babyfood 4.000000 1.000 1.000 

9500280000 O Pineapple, dried 4.000000 5.000 1.000 

9500281000 O Pineapple, juice 4.000000 1.000 1.000 

9500281001 O Pineapple, juice-babyfood 4.000000 1.000 1.000 

9500333000 O Sapote, Mamey 2.500000 1.000 1.000 
Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

___________________________________________________________________________________________

Page 15 of 20

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

U.S. EPA Ver. 3.16, 03-08-d

DEEM-FCID ACUTE Analysis for TRIFLUMIZOLE NHANES 2003-2008 2-Day

Residue file: 128879A.R08 Adjustment factor #2 NOT used.

Analysis Date: 08-20-2013/09:07:44 Residue file dated: 08-20-2013/08:02:24

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

RAC/FF intake summed over 24 hours

Run Comment: ""

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

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

 Exposure % aPAD Exposure % aPAD Exposure % aPAD 

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

Total US Population:

 0.063555 25.42 0.116822 46.73 0.216316 86.53 

All Infants:

 0.046533 18.61 0.109217 43.69 0.277180 110.87 

Children 1-2:

 0.099738 39.90 0.185510 74.20 0.408983 163.59 

Children 3-5:

 0.090227 36.09 0.184659 73.86 0.265504 106.20 

Children 6-12:

 0.058912 23.56 0.117290 46.92 0.190734 76.29 

Youth 13-19:

 0.048310 19.32 0.099460 39.78 0.251838 100.74 

Adults 20-49:

 0.062830 25.13 0.114721 45.89 0.211577 84.63 

Adults 50-99:

 0.062045 24.82 0.105279 42.11 0.193090 77.24 

Female 13-49:

 0.066279 66.28 0.126576 126.58 0.220461 220.46 
Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

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Page 16 of 20

ATTACHMENT 3: Residue File for Chronic Dietary (Food + Drinking Water)

Filename: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 3.16\128879C.R08

Chemical: Triflumizole

RfD(Chronic): .012 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .25 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 08-20-2013/08:57:49 Program ver. 3.16, 03-08-d

Comment: Triflumizole chronic ARs %CT

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0401005000 4A Amaranth, leafy 11.100000 1.000 1.000 

0401018000 4A Arugula 11.100000 1.000 1.000 

0401104000 4A Chrysanthemum, garland 11.100000 1.000 1.000 

0401133000 4A Cress, garden 11.100000 1.000 1.000 

0401134000 4A Cress, upland 11.100000 1.000 1.000 

0401138000 4A Dandelion, leaves 11.100000 1.000 1.000 

0401150000 4A Endive 11.100000 1.000 1.000 

0401204000 4A Lettuce, head 2.970000 1.000 1.000 

0401205000 4A Lettuce, leaf 11.100000 1.000 1.000 

0401248000 4A Parsley, leaves 11.100000 1.000 1.000 

0401313000 4A Radicchio 2.970000 1.000 1.000 

0402367000 4B Swiss chard 5.480000 1.000 1.000 

0501061000 5A Broccoli 1.790000 1.000 1.000 

0501061001 5A Broccoli-babyfood 1.790000 1.000 1.000 

0501062000 5A Broccoli, Chinese 1.790000 1.000 1.000 

0501064000 5A Brussels sprouts 0.740000 1.000 1.000 

0501069000 5A Cabbage 0.740000 1.000 1.000 

0501071000 5A Cabbage, Chinese, napa 0.740000 1.000 1.000 

0501072000 5A Cabbage, Chinese, mustard 0.740000 1.000 1.000 

0501083000 5A Cauliflower 1.790000 1.000 1.000 

0501196000 5A Kohlrabi 0.740000 1.000 1.000 

0502063000 5B Broccoli raab 7.720000 1.000 1.000 

0502070000 5B Cabbage, Chinese, bok choy 7.720000 1.000 1.000 

0502117000 5B Collards 7.720000 1.000 1.000 

0502194000 5B Kale 7.720000 1.000 1.000 

0502229000 5B Mustard greens 7.720000 1.000 1.000 

0502318000 5B Rape greens 7.720000 1.000 1.000 

0502389000 5B Turnip, greens 7.720000 1.000 1.000 

0801374000 8A Tomatillo 0.590000 1.000 1.000 

0801375000 8A Tomato 0.590000 1.000 1.000 

0801380000 8A Tomato, Tree 0.590000 1.000 1.000 

0901075000 9A Cantaloupe 0.170000 1.000 0.100 SLUA o

 Full comment: SLUA of Jan 2013

0901187000 9A Honeydew melon 0.170000 1.000 0.150 SLUA o

 Full comment: SLUA of Jan 2013

0901399000 9A Watermelon 0.170000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

0901400000 9A Watermelon, juice 0.170000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

0902021000 9B Balsam pear 0.250000 1.000 1.000 

0902088000 9B Chayote, fruit 0.140000 1.000 1.000 

0902102000 9B Chinese waxgourd 0.250000 1.000 1.000 

0902135000 9B Cucumber 0.250000 1.000 0.025 SLUA o

 Full comment: SLUA of Jan 2013

0902308000 9B Pumpkin 0.140000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

0902309000 9B Pumpkin, seed 0.140000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

0902356000 9B Squash, summer 0.140000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

0902356001 9B Squash, summer-babyfood 0.140000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

0902357000 9B Squash, winter 0.140000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

0902357001 9B Squash, winter-babyfood 0.140000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

1100007000 11 Apple, fruit with peel 0.140000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013
Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

___________________________________________________________________________________________

Page 17 of 20

1100008000 11 Apple, peeled fruit 0.140000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1100008001 11 Apple, peeled fruit-babyfood 0.140000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1100009000 11 Apple, dried 0.140000 8.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1100009001 11 Apple, dried-babyfood 0.140000 8.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1100010000 11 Apple, juice 0.140000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1100010001 11 Apple, juice-babyfood 0.140000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1100011000 11 Apple, sauce 0.140000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1100011001 11 Apple, sauce-babyfood 0.140000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1100129000 11 Crabapple 0.140000 1.000 1.000 

1100210000 11 Loquat 0.230000 1.000 1.000 

1100266000 11 Pear 0.230000 1.000 0.450 SLUA o

 Full comment: SLUA of Jan 2013

1100266001 11 Pear-babyfood 0.230000 1.000 0.450 SLUA o

 Full comment: SLUA of Jan 2013

1100267000 11 Pear, dried 0.230000 6.250 0.450 SLUA o

 Full comment: SLUA of Jan 2013

1100268000 11 Pear, juice 0.230000 1.000 0.450 SLUA o

 Full comment: SLUA of Jan 2013

1100268001 11 Pear, juice-babyfood 0.230000 1.000 0.450 SLUA o

 Full comment: SLUA of Jan 2013

1100310000 11 Quince 0.230000 1.000 1.000 

1201090000 12A Cherry 0.660000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1201090001 12A Cherry-babyfood 0.660000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1201091000 12A Cherry, juice 0.660000 1.500 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1201091001 12A Cherry, juice-babyfood 0.660000 1.500 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1302057000 13B Blueberry 0.530000 1.000 1.000 

1302057001 13B Blueberry-babyfood 0.530000 1.000 1.000 

1302174000 13B Gooseberry 0.550000 1.000 1.000 

1304175000 13D Grape 0.550000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

1304176000 13D Grape, juice 0.550000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

1304176001 13D Grape, juice-babyfood 0.550000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

1304179000 13D Grape, wine and sherry 0.550000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

1307359000 13G Strawberry 0.530000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1307359001 13G Strawberry-babyfood 0.530000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1307360000 13G Strawberry, juice 0.530000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1307360001 13G Strawberry, juice-babyfood 0.530000 1.000 0.250 SLUA o

 Full comment: SLUA of Jan 2013

1400155000 14 Hazelnut 0.050000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

1400156000 14 Hazelnut, oil 0.050000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

1901118000 19A Cilantro, leaves 11.100000 1.000 1.000 

1901118001 19A Cilantro, leaves-babyfood 11.100000 1.000 1.000 

1901249000 19A Parsley, dried leaves 35.000000 1.000 1.000 

1901249001 19A Parsley, dried leaves-babyfood 35.000000 1.000 1.000 

3100046000 31 Beef, meat byproducts 0.200000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.200000 1.000 1.000 

3100047000 31 Beef, fat 0.100000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.100000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.200000 1.000 1.000 

3200171000 32 Goat, fat 0.100000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.200000 1.000 1.000 
Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

___________________________________________________________________________________________

Page 18 of 20

3500341000 35 Sheep, fat 0.100000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.100000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.022000 1.000 1.000 D40768

 Full comment: D407680, 5/20/13

8602000000 86B Water, indirect, all sources 0.022000 1.000 1.000 D40768

 Full comment: D407680, 5/20/13

9500074000 O Canistel 0.630000 1.000 1.000 

9500177000 O Grape, leaves 0.550000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

9500178000 O Grape, raisin 0.550000 1.000 0.050 SLUA o

 Full comment: SLUA of Jan 2013

9500188000 O Hop 14.400000 1.000 1.000 

9500215000 O Mango 0.630000 1.000 1.000 

9500215001 O Mango-babyfood 0.630000 1.000 1.000 

9500216000 O Mango, dried 0.630000 1.000 1.000 

9500217000 O Mango, juice 0.630000 1.000 1.000 

9500217001 O Mango, juice-babyfood 0.630000 1.000 1.000 

9500245000 O Papaya 0.630000 1.000 1.000 

9500245001 O Papaya-babyfood 0.630000 1.000 1.000 

9500246000 O Papaya, dried 0.630000 1.800 1.000 

9500247000 O Papaya, juice 0.630000 1.500 1.000 

9500279000 O Pineapple 2.170000 1.000 1.000 

9500279001 O Pineapple-babyfood 2.170000 1.000 1.000 

9500280000 O Pineapple, dried 2.170000 5.000 1.000 

9500281000 O Pineapple, juice 2.170000 1.000 1.000 

9500281001 O Pineapple, juice-babyfood 2.170000 1.000 1.000 

9500333000 O Sapote, Mamey 0.630000 1.000 1.000 
Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

___________________________________________________________________________________________

Page 19 of 20

ATTACHMENT 4: Chronic Dietary (Food + Water) Exposure Analysis

U.S. EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for TRIFLUMIZOLE NHANES 2003-2008 2-day

Residue file name: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 

3.16\128879C.R08

 Adjustment factor #2 used.

Analysis Date 08-20-2013/09:05:53 Residue file dated: 08-20-2013/08:57:49

Reference dose (RfD, Chronic) = .012 mg/kg bw/day

COMMENT 1: Triflumizole chronic ARs %CT

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 Total exposure by population subgroup

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 Total Exposure

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 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.002571 21.4%

Hispanic 0.002466 20.5%

Non-Hisp-White 0.002589 21.6%

Non-Hisp-Black 0.002526 21.1%

Non-Hisp-Other 0.002723 22.7%

Nursing Infants 0.001322 11.0%

Non-Nursing Infants 0.003207 26.7%

Female 13+ PREG 0.002466 20.5%

Children 1-6 0.004045 33.7%

Children 7-12 0.002045 17.0%

Male 13-19 0.001625 13.5%

Female 13-19/NP 0.001831 15.3%

Male 20+ 0.002418 20.1%

Female 20+/NP 0.002730 22.7%

Seniors 55+ 0.002512 20.9%

All Infants 0.002625 21.9%

Female 13-50 0.002530 21.1%

Children 1-2 0.004641 38.7%

Children 3-5 0.003741 31.2%

Children 6-12 0.002281 19.0%

Youth 13-19 0.001728 14.4%

Adults 20-49 0.002563 21.4%

Adults 50-99 0.002602 21.7%

Female 13-49 0.002531 21.1%

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Triflumizole (128879) Dietary Exposure and Risk Assessment D413699

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Page 20 of 20

ATTACHMENT 5. Triflumizole SLUA

January 30, 2013 

Screening Level Estimates of Agricultural Uses of Triflumizole (128879)

Sorted Alphabetically

(Reporting Timeframe: 2004-2011)

Percent Crop Treated

Crop Lbs. A.I. Average Maximum

1 Apples 40,000 25 40

2 Brussels Sprouts * <500 N/C N/C

3 Cantaloupes 2,000 10 25

4 Cherries 10,000 25 35

5 Cucumbers <500 <2.5 10

6 Grapes 20,000 5 15

7 Hazelnuts (Filberts) <500 5 15

8 Honeydews 1,000 15 30

9 Pears 10,000 45 60

10 Pumpkins 1,000 5 15

11 Squash 1,000 5 10

12 Strawberries 5,000 25 40

13 Watermelons 2,000 5 10

All numbers rounded.

<500 Less than 500 pounds of active ingredient

<2.5 Less than 2.5 percent of crop treated

* Based on CA DPR data only/ N/C = not calculated, only lbs. A.I. available

SLUA data sources include: 

USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service) 

Private Pesticide Market Research

California DPR (Department of Pesticide Regulation)

These results reflect amalgamated data developed by the Agency and are releasable to the public.