### UNITED ST A T E S ENVIRONMENTAL PROTEC T ION AGENCY

WASHINGTON, D.C. 20460

MEMORANDUM

DATE: 22 -AUG-2013 OFFICE OF
CHE M ICAL SA FETY AND
POLLUTION PREVENTION



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

and Risk Assessments for Greenhouse Uses on Tom ato and Cucumber;

Translations of Apple and Pear to Pome Fr uit Group 11-10, Grape to Crop Subgroup 1 3-07F, and Strawberry to Crop Subgroup 13-07G, Except Cranberry.

PC Code: 1288 79

Decision No.: 472282

Pet ition No.: 2E8119 DP Barcode : D413699 Registration Nos.: 400-436, -518

, -521 Regulatory Action: Section 3 Regis tration

Case No.: NA Risk Assessment Type: Diet ary
TXRNo.: NA CAS No.: 68694-11-1

40 CFR: §180.476 MRID No.: NA

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

---- Dietar y Exposure Science Advisory Council

# (D**AC)** HED (7509P)

Andrew Ertman/Barbara Ma dd en, 

## 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 In take 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 h ealt h risk assessment for the proposed Section

Page I of20T riflumizole (128879) Dietary Exposure and Risk Ass e ssment 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 Resu l ts and Characterization

A conservative acute dietary assessment was conducted using tolerance

- level residues, 100%

crop treated assumptions

, and modeled water estimates

. At the 95 1 h 

### percentile of exposure, the

est im ated 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 stud i es. Therefore, a cancer dietary exposure ana l ysis is not required.

I. 

### Introduction



### Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acut e 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 d i etary risk exceeds 100%

of the PAD. References which discuss the acute and chronic risk assessments in more detail are availab l e on the EPA/pesticides web site: "Available Information on Assessing Exposure from
Pesticides, A User's Guide," 21-JUN-2000, web link: http:/ /www

. e p a.gov /fe dr g str/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 by W. Donovan (D397935

, 28-MAR

- 2012).

Pa g e 2 o f 20Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 3 of 20 

### 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

- h ydroxy

- 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, b ased 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

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

-- 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 4.0Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 4 of 20 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

. T olera nces 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 ( D 354063, 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

- trifluoromethylani line moiety (calculated as triflumizole ) ( D 280869

, J. Tyler,

3/13/02 ).Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 5 of 20 

### 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 c ombined 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 ( D 280869 , 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 t rial data were used for apple, grape, pear, cherry, cucurbit vegetables

, strawberry, l eafy greens (subgroup 4A) except spinach, head and stem Brassica (subgroup 5A), cilantro, Swiss chard, pineapple, papaya, canistel, mamey sapote, mango, and hops

. See Ta ble 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

COMMODITY 1 ACUTE ASSESSMENT CHRONIC ASSESSMENT

Tolerance (ppm) Processing

Factors AR 2

(ppm) %CT 3 Processing

Factors

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

Leaf Lettuce 11.1 NR NA

Brass ica , head and stem, subgroup 5A 8.0 NA Cabbage 0.74

Broccoli 1.79 NR NA

Brassica leafy greens subgroup 5B 5 40 NA 7.72 NR NA

Muskmelons , subgroup

9A 6 0. 8 NA 0.17 10/15 8 NA

Summer s quash

, subgroup 9B 6 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

Apple 9 0.5 Juice

– 1.0

Sauce

– 1.0

Dried

– 8.0 0.14 2 5 Juice

– 1.0

Sauce

– 1.0

Dried

– 8.0

Pear 9 0.5 Dried

– 6.25 0.23 4 5 Dried

– 6.25

Grape 9 2.5 Juice

– 1.0

Raisin

– 1.0 0.55 5 Juice

– 1.0

Raisin

– 1.0

Cherr y 10 1.5 Juice

– 1.5 0.66 25 Juice

– 1.5
Coriander, leaves 35 NA 11.1 NR NATriflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 6 of 20 TABLE 2 : Summary of Residue Values Used in the Dietary (Food + Drinking Water) Risk Assessments for

Triflumizole

COMMODITY 1 ACUTE ASSESSMENT CHRONIC ASSESSMENT

Tolerance (ppm) Processing

Factors AR 2

(ppm) %CT 3 Processing

Factors

Hazelnuts (Filberts) 11 0.05 NA 0.05 5 NA Hop, dried cones 50 NA 14.4 NR NA

Strawberr y 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

– 1.0

Dried

– 5.0
Papaya 2.5 Juice

– 1.5

Dried

– 1.8 0.63 NR Juice

– 1.5

Dried

– 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

Recommend ed Livestock Commodities

Fat 14 0. 10 NA 0.10 NA NA Meat byproducts (Mbyp) 1 4 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 A vailable; 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 cantaloupe s 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

. 1 1 Filbert: D312293, J. Tyler, 18

- MAY

- 2005.

12 MRID 48998102.

1 3 Strawberry: D274589, J. Tyler, 11

- MAR

- 2002.

1 4 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 defi nition for parsle y 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

tolerance s on parsley and cilantro leaves (D34 6779, W. Cutchin, 01

- OCT

- 2008)

. Note that t he preferred commodity terminology for cilantro is coriander.Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 7 of 20 

### DEEM does not include a default processing factor for parsley, dried leaves . To account for the potentially higher residues in parsley, dried leav es, tolerance level residues for subgroup 4A were used for this commodity.

Processing Factors : The combined triflumizole residues did not c oncentrate 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 regardles s of the pesticide’s uses and physicochemical properties. In 2008, PDP analyze d 552 catfish samples for triflumizole, reporting no de te ct ions. As a result, residues in fish were not included in the assessment

.

III. Percent Crop Treated Information

Upd ated 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, pumpk ins, squash, strawberries, and watermelons in a Screening Level Us age Analysis (SLUA) dated 30

- JAN

201 3 . Although BEAD provided maximum and average %CT information, only the average %CT values were utilized in the dietary exposure analysis.

The followi ng average pe rcent 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: 2 5 %; 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; D P Num: 280869

, J. Tyler, 3/13/02) : “ Tier II Drinking

Water Assessment to Establish Tolerances of Triflumizole on Gree nhouse 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

, D 407680

. 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

- GWTriflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 8 of 20 

### concentration estimates were less t han 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. M aximum acute and chronic EDWC values were obtained using the maximum a ppl ication scenario s 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, t he chronic

EDWC of 2 2 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. 0 98 and 0.02 2 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 DEEM

FCID, 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 p ublicly 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, consu mption 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

followi ng 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

- 4 9, 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 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 e stimate 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 t he 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 multip lied 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 distr ibution 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) bas is. In accordance with HED policy, per capitaTriflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 9 of 20 

### 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 ( D 393221

, 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 UF A = 10x

UF H = 10x FQPA SF= 1x Acute RfD = 0.25

mg/kg/day Acute Ne u rotoxicity

– Rat

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

loco m otor activity

.

Acute Dietary (Females 13

- 49 years of age) NOAEL= 10

mg/kg/day UF A = 10x

UF H = 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) L OAEL= 3.5

mg/kg/day UF A = 10 x

UF H = 10 x FQPA SF= 3 x Chronic RfD = 0.0 3 5

mg/kg/day

cPAD = 0.0 12 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 =

u ncertainty factor. UF A = extrapolation from animal to human (int er species). UF H = potential variation in sensitivity among members of the human population (int ra species). UF L = use of a LOAEL to extrapolate a

NOAEL. UF S = use of a short

- term study for long

- term risk assessment. UF DB = 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 = le vel 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 functionalTriflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 10 of 20 

### 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 c ombined c hronic

t oxicity/ c arcinog enicity s tudy in r at s; a NOAEL was not established. An uncertainty factor of 300x (10x for interspecies extrapolation, 10x intraspecies extr apolation and 3x for the use of a LOAEL (UF L 

### )) 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 mos t 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 th e other studies such as the reproduction (3.5 m g /k g /d ay ), subchronic rat (15.3 m g /k g /d ay ), subchronic mouse (33.1 m g /k g /d ay )

, chronic dog 10 m g /k g /d ay ) and the mouse carcinogenicity (16.2

m g /k g /d ay ) studies.

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

- related chemical ( i mazalil).

VI I

. 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 lik ely to be carcinogenic to humans”; therefore, a triflumizole c ancer 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 ac ute dietary (food + drinking water) expo sure 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. Th is assessment
indicated that the acute dietary exposure estimates ( at the 95 th 

### percentile) are below the Agency’sTriflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 11 of 20 

### level of concern (<100% of the aPAD) for the general U.S. population ( 2 5 % of the aPAD) and all population subgroups . Exp osure 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 us ed ARs from average field trial residues

. The assessment used % CT

information where available, and 100% CT for all oth er 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 su rface water generated by the

PRZ M/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 ( 2 1 % of the cPAD) and all population subgroups. The most highly exposed population subgroup

is children 1

- 2 years old at 3 9 % 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 0.06 3 555 2 5 0.002 5 71 2 1

N/A N/A All Infants (< 1 year old) 0.04 6 533 1 9 0.002 6 25 2 2

Children 1

- 2 years old 0.09 9 738 40 0.00 4 641 3 9

Children 3

- 5 years old 0.0 90 227 36 0.003 7 41 3 1

Children 6

- 12 years old 0.0 58 912 2 4 0.002 2 81 19

Youth 13

- 19 years old 0.0 48 310 19 0.001 7 2 8 14

Adults 20

- 49 years old 0.06 2 8 30 25 0.002 5 63 2 1

Adults 50

- 99 years old 0.06 2 045 25 0.002 6 02 22

Females 13

- 49 years old 0.06 6 279 6 6 0.002 5 31 2 1



### VII I

. 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 o f application and shortest preharvest interval (PHI).Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 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 th e level of refinement of the assessments, the acute dietary assessment is unrefined in that it assumes that 100% of eligibl e 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 con servative assessment of potential

risk to residues of triflumizole in the diet.

Should further refinements become necessary, utilization of the max imum %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 de tections (10%). However, no samples exceeded the established

tolerance level s . M ost crops had residues of triflumizole b elow 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 95 th 

### percentile is below the Agency’s level of concern for all population subgroups evaluated.

The chron ic dietary (food + drinking water) exposure assessment us ed ARs and %CT

information as available

. Drinking water was incorporated directly into the assessment

. Chronic

e xposure estimates for all populat ion subgroups are below the Agency’s level of concern.

HED is confident that the assessment s provided in this memorandum do not underestimate risk to the general U.S. populat ion 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) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 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 35.00 0000 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

040 1138000 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, lea f 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

0 501064000 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, C hinese, 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 4 0.000000 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 Tomatill o 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 Cucumb er 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 1.0 00 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 Appl e, 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 1.000Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 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

13021740 00 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

- baby food 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 2.00000 0 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

140015 6000 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, mea t 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, rais in 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, j uice 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, M amey 2.500000 1.000 1.000Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 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 rep orts 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:

0.06 2830 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 220.46Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0401005 000 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 11.1000 00 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

04013 13000 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

- babyf ood 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 Cauliflow er 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

090 1400000 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 0.140 000 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 2013Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 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 0.140 000 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

Fu ll 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 c omment: 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

- ba byfood 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

1304 176000 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

1307 359001 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

13073600 01 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 1 4 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 1.0 00 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 1.000Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 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 14.4000 00 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

95002 17000 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

- babyfoo d 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 2.17 0000 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

950 0281001 O Pineapple, juice

- babyfood 2.170000 1.000 1.000 9500333000 O Sapote, Mamey 0.630000 1.000 1.000Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 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

==================================== =========================================== Total exposure by population subgroup

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

Total Exposure

----------------------------------- 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 0.002 530 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%

-------------------------------------------------------------------------------Triflumizole (128879) D ietary Exposure and Risk Assessment D 413699

______________________________________________________________________________________ _____

P age 20 of 20 

### A TTACHMENT 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 re leasable to the public.