Fluoxastro b in

PC Code: 028869 Dietary Exposure and R i s k Assessment DP Number: 409517



### UNITED S TATES ENVIRONMENTAL PRO TECT I ON AGENCY

WASH INGTON, D.C. 20460



### MEM ORAND UM

DATE: 03/21/2013 OFFICE OF CHEM IC AL SAFETY
AND POLLUTION PREVENTION



### SU BJECT: F l uoxastrobin : Chronic Dietary (Food and Drinkin g Water) Exposure

Assessments for the Section 3 Registra t ion Action Uses on Me l on Subgroup 9A, Sorg hum

, and Wheat. Amendments to Established

T o l erances on M ilk and M i lk Fat.



### PC Code: 028869


### Decision Nos.: 465774, 473405


### Petition N os.: 2F804 7

, 2F8 1 30



### Risk Assessment Type: Dietary


### TXRNo.: NA



### MRIDNo.: NA



### REVIEWER: Meheret Negussie, Chemist

Risk Assessment Branch III

Health Effects Di vision (7509 P ) 

### DP Barcode: D409517 

### Registration No.: 66330-64 

### Regulatory Action: Sect i o n 3

Re g i str atio n 

### Case No.: NA


### CAS N o.: 361377-29-9

40 

### CFR: §180.609



### THROUGH: Sheila Piper

, Senior

# Chem**~'s t** **~** -

# ~.vJ Seye d Tadayon, Chemist Dietary Exposur e Sc ien ce A visory Co uncil (DESAC)

Health Effects Division (7509P)



### T O : Christ i ne Olinger, Branch Chief Nancy Tsaur, Chemist/Risk Assessor

Risk Assessmen t Branch III

Health Effects Divi s ion (7509P)

Willi am C utchin/Heath e r Garvie, RM Team #20 Registration Division (7505P)

Pagelofl3Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 409517



### Executive Summary



### Chronic aggregate dietary (food and drinking water) exposure and risk assessment was conducted using the Die tary Exposure Evaluation Model software with th e Food

Commodi ty Intake Database (DEEM-FCID) Version 3.16. Thi s software uses 2003 -2008

food consumption data from the U

. S. Department of Agriculture

, s (USDA's) Na t i ona l

Health and N utr i t ion Exam ina t ion Survey, What We Eat in America, (NHANES/WWEIA). The analyses were conducted in s upport of a human healt h risk

assessment for the proposed Section 3 requests on melon subgroup 9A, sorghum, wheat

and to amend the established tolerances of milk and milk fat. This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

Acute Dietary Exposure Results and Characterization:

No toxic effects attri b utable to a single exposure to fluoxastrobin have been iden t ified; therefore, an acute reference dose (aRID) has not been established and an acute dietary

exposure assessment was not conducted.

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

A partially refined dietary exposure assessment was performed for fluoxastrobin. The assumptions of this dietary assessment include tolerance level residues, average field trial

residues and 100% crop t re ated (CT). DEEM version 7.81 default processing factors

were assumed except for where tolerances were established for processed commodities or when processing studies showed no concentration. Estimated drinking water
concentration (EDWC) values were also incorporated. The estimated ground water post breakthrough ave ra ge concentration of 137 J..Lg/L was i ncorporat ed directly into the dietary assessment. The results of the chronic dietary analysis for food and drinking

water are below the Agency's l evel of concern (LOC) for all population subgroups. The dietary exposure for food and water is estimated at 30% of the chronic Population Adjusted Dose (cPAD) for the general U

. S

. population and 66%, of the cPAD for all

infants < 

### 1 year old, the population subgroup with the highes t estimated chronic dietary

expos ur e to fluoxastrobin.

Cancer Dietary Exposure Results and Characterization

The Cancer Assessment Review Committee (CARC) recentl y concluded that

fluoxastrobin is "not likely to be carcinogenic to humans;" therefore, cancer risk was not
assessed

.



### I. Introduction



### Dietary risk assessment incorpora tes bo th exposure and toxicity of a given pesticide. For

acute and chronic assessments, th e risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will re su lt in no unreasonable

adverse hea l th effects). This dose is referred to as the population adjusted dose (PAD).

Page 2 of 13Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

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Page 3 of 13 

### The PAD is equivalent to the reference do se po int of d eparture ( PO D , NOAEL, LOAEL ) divided by the required uncertainty and s afety f actor s

.

For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generally concerned when estimated cance r risk

exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web

link: http://www.epa.gov/fedrgstr/EPA

- PEST/2000/July/Day

- 12/6061.pdf ; or see SOP 99.6 (8/20/99).

This dietary assessment is an update to the fluoxa strobin di etary assessment ( D4 02506

, M. Negussie

, 06/19 /2012)

.

II. Residue Information

Fluoxastrobin is a fungicide used for the control of fungal diseases in tuberous and corm vegetables, fruiting vegetables, the leaf petiole vegetables, low growing berries, squash

and cucumbe rs, field and sweet corn, peanuts, soybeans, w heat, rice, and as a seed treatment for potato and peanut, and for soilborne/seedling disease control. Tolerances

for combined residues of fluoxastrobin and its Z

- isomer in/on primary crop commodities

are esta blished under 40 CFR §180.609(a)(1) at levels ranging from 0.010 ppm to 60 ppm. Tolerances are established under 40 CFR §180.609(a)(2) for the combined residues of fluoxastrobin, its Z

- isomer, and its phenoxy

- hydroxypyrimidine metabo lite, 6

- (2

- chlorophenoxy)

- 5

- fluoro

- 4

- pyrimidinol, in cattle, goat, hog, horse, and sheep commodities and poultry liver at levels ranging from 0.02 ppm (milk) to 0.50 ppm (milk fat).

Th e residues of concern in primary crops, rotational crops , and livesto ck, for tolerance

enforcement and risk assessment are as follows: primary crops/ rotational crops

fluoxastrobin and its Z

- isomer ; livestock

- fluoxastrobin

, its Z

- isomer and 6

- (2

- chlorophenoxy)

- 5

- fluoro

- 4

- pyrimidinol ( D P 289106, W. Wassel l , 01/25/ 20 05 )

.

Table 1 is a summary of the HED recommended food tolerances resulting from the proposed uses on melon subgroup 9A

, sorghum , wheat and amend the established

tolerances of milk and milk fat (DP 403571 , M. Negussie, 03/21 /201 3 )

.

Table 1

. Summary of Pro posed Tolerances for Fluoxastrobin
Commodity Proposed

Tolerance (ppm) Recommended Tolerance (ppm) Comments [ Correct Commodity

Definition ]

Melon, subgroup 9A 1.5 1.5 Melon subgroup 9A
Sorghum grain 1.5 1.5 Sorghum, grain
Wheat, grain 0.15 0.15

Wheat, bran 0.15

Established None Revoke. The recommended tolerance on wheat, grain will coverFluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

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Page 4 of 13 Table 1

. Summary of Pro posed Tolerances for Fluoxastrobin
Commodity Proposed

Tolerance (ppm) Recommended Tolerance (ppm) Comments [ Correct Commodity

Definition ]

expected residues in wheat bran.

Livestock Tolerances That Need to be Revised
Commodity Established

Tolerance (ppm) Proposed

Tolerance (ppm) Recommended

Tolerance (p pm)

Milk 0.02 0.03 0.03

Milk, fat 0.50 0.75 0.75



### Residue Data used for Chronic Assessments:

T olerance level residues , average field trial residues, and 100% CT were assumed. Average field trial residues were used for melon su bgroup 9A, berry low growing subgroup 13

- 07G, leaf petioles subgroup 4B, rice, squash/cucumber subgroup 9B, and vegetable fruiting group 8

. Based on processing studies, the processing factors for

tomato puree, potato chips, dried potato (granules/flakes), and potato flour were reduced

to 1

. Separate tolerances were set for peanut oil and tomato paste; therefore, the processing factors for these commodities were set at 1 ( DP 289106 , W.D. Wassell,

01/25/2005 ). DEEM TM version 7.81 default processing factors were assumed f or all other processed commodities for which they were available

. Field trial data were translated from the representative commodities to the non

- representative commodities according to HED SOP 2000.1 :”Guidance for Translation of Field Trial Data from Representative Commodities in the Crop Group Regulation to other Commodities in Each Crop Group/Subgroup.” Table 2 is a summary of the average residues and Table 3 is a summary of the processing factors used in the dietary assessment

.

Table 2

. Summary of Average Residues Used for Fluoxastrobin.

Commodity Established Tolerance (ppm) Average Residues (ppm)
Melon, subgroup 9A 1.5 0.282
Berry, low, growing, subgroup 13

- 07G 1.9 0.56

Leaf petioles s ubgroup 4B 4.0 2.09
Rice, grain 4.0 1.177
Squash/cucumber 9B 0.50 Cucumber

- 0.09

Summer Squash

- 0.08
Vegetable, fruiting, group 8 1.0 Tomato

- 0.203

Pepper

- 0.214Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

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Page 5 of 13 T able 3

. Processing Factors (PF) for Fluoxastrobin Dietary Risk Assessment.

Pr ocessed Commodity PF Source Beef, meat, dried 1.92 DEEM Default
Corn grain, sugar/hfcs 1.5 DEEM Default
Cranberry

, j uice 1.1 DEEM Default

Peanut, butter 1.89 DEEM Default

Peanut, oil 1.0 Tolerance for p eanut

, oil accounts for processing

. Potato

, d rie d and f

lour 1.0 Processing Study

Tomato, dried 14.3 DEEM Default
Tomato, juice 1. 5 DEEM Default

Tomato , p aste 1.0 Tolerance for t omato, paste accounts for processing

. Tomato , p uree 1.0 Processing Study



### III. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the

Environmental Fate and Effects Division ( EFED ) ; ( DP 40 3757 , R. Bohaty, 02 / 05 / 20 1 3 ) and incorporated directly into this dietary assessment. Water residues were incorporated

in the DEEM

- FCID into the food categories “water, direct, all sources” and “w ater, indirect, all sources.”

EDWC s for surface water are based on the Tier I I model. Based on this model estimate,

t he proposed use s of fluoxastrobin on melon and sorghum may result in a peak

c oncentrat ion of 48.7 μg/L and 1 in 10 year annual average concentration of 7.9 ug/L in

surface water

. The previous EDWC of 93 μg/L estimated for rice is higher than the EDWC resulting from the proposed uses

.

Reevaluation of the turf use using the Wiscons in scenario (the use with the highest single maximum application rate, as well as the highest yearly application rate) using PRZM

GW 1 

### indicates that continued use of fluoxastrobin over many years (based on a 100 year simulation with 100 years of repeated a pplications) at the maximum label rates for turf may result in groundwater concentrations that are greater than EDWCs previously reported for surface water as shown in Table 5

.

Table 4. Tier II Surface Water Estimated Drinking Water Concentrations R esulting From the Proposed Use of Fluoxastrobin on Melon and Sorghum.

Parameter Tier II Surface Water (μg/L)

Melons Sorghum Turf

Acute

1

- in

- 10 Year Peak Concentration

μg/L 48.7 7.0 24.8

Chronic

1

- in

- 10 Year Annual Average Concentration 7.9 4.6 18.6

1 PRZM

- GW was recently (12/2012) approved for standard use in drinking water assessments are a Tier I and Tier II exposure tool.Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

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Page 6 of 13 μg/L

Cancer 30 Year Annual Average Concentration

μg/L 5.0 3.5 12.2



### Table 5

. Tier I Groundwater Estimated Drinking Water Concentrations Resulting From the Proposed Use of Fluoxastrobin on Melon and Sorghum

.

Parameter Tier I Ground w ater (μg/L)

M elons Sorghum Turf

Peak Concentration μg/L 47.1 a 15.3 a 146 a

Post Breakthrough Average

Concentration μg/L 44.2 a 14.3 a 137 a

Average Breakthrough Time

(days) 14529 b 14529 b 14529 b

a. extended weather file used; 100 year simulation with100 years of r epeated applications

b. Reported for the scenario with the shortest average breakthrough time. The reported values are not from the scenario for which the EDWCs are reported.

Bold font indicates most conservative values for all fluoxastrobin uses.



### IV. DEEM

- FCID Program and Consumption Information

Fluoxastrobin chronic dietary exposure assessment was conducted using the DEEM

FCID, Version 3.16, which incorporates 2003

- 2008 consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consum ption 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 ass essment, 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 f or 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 chronic dietary exposure assessment, an est imate 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 resi due 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.Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

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Page 7 of 13 

### V. Toxicological Information

The toxicity endpoints pertinent for human dietary risk assessment are summarized in

Table 6

.

Table 6 . Summary of Toxicological Doses and Endpoints for Fluoxastrobin for Use in Dietary Exposure Risk Assessments. Exposure/

Scenario Dose Used in Risk Assessment, UF FQPA SF and

Endpoint for Risk

Assessment Study and Toxicological

Effects

Acute Dietary (General Population) No acute endpoint was identified for the general population.
Acute Dietary (Females 13

- 49 years of age) Chronic Dietary all Populations NOAEL = 1.5

mg/kg/day

UF = 100
Chronic RfD = 0.015 mg/kg/day FQPA SF = 1X

cPAD = chronic RfD FQPA SF

= 0.015 mg/kg/day Chronic toxicity study with

dogs.

LOAEL = M/F:8.1/7.7 mg/kg/day based on body weight reductions and hepatocytomegaly and cytoplasmic changes associated

with increased serum liver alkaline phosphatase indicative

of cholestasis.

Cancer (oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans.

NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainity factor. FQPA SF = FQPA Safety Factor. PAD = population adjusted do se (a = acute, c = chronic). RfD = reference dose.



### VI. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk

exceeds 100% of the PAD. The DEEM

- FCID analyses estimate the dietary exposure of

the U.S. population and various population subgroups. The results reported in Table 7 are for the general U.S. Population, all infants (<1 year old), children 1

- 2, children 3

- 5,

children 6

- 12, youth 13

- 19, females 13

- 49, adults 20

- 49, and adults 50+ years

.

Res ults of Chronic Dietary Exposure Analysis

The results of the aggregate chronic dietary analysis for food and drinking water are below the Agency’s level of concern (<100% cPAD) for the general U.S. population ( 3 0 % cPAD) and all population subgroups. The most highly exposed population

su bgroup is all infants < 1 year old at 66 % of the cPAD. The results of the chronic dietary exposure analys e s are reported in Table 7 below.Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

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Page 8 of 13 T able 7

. Res ult of Chronic Dietary Exposure and Risk Estimates for Fluoxas trobin

. 1

Population Subgroup PAD, mg/kg/day DEEM

- FCID (food and water)

Exposure, mg/kg/day %PAD

Chronic Dietary Estimates

U.S. Population

0.015 0.00 4 5 29 3 0

All infants (< 1 yr) 0. 00988 6 66

Children 1

- 2 yrs 0.0 09 51 6 6 3

Children 3

- 5 yrs 0.0 07 496 5 0

Children 6

- 12 yrs 0.00 5 05 2 3 4

Youth 13

- 19 yrs 0.00 3 51 4 2 3

Adults 20

- 49 yrs 0.00 4 2 26 28

Adults 50+ yrs 0.00 3999 2 7

Females 13

- 49 yrs 0.00 4 1 18 28

1 The population subgroup with the greatest exposure is in bold



### Cancer Dietary Exposure Resul ts and Characterization

As noted above, the HED CARC has recently revisited the cancer classification for

fluoxa strobin. HED has reclassified fluoxa strobin as “not likely to be carcinogenic to

humans ; ” therefore cancer risk is not of concern

.

VIII. Cha racterization of Inputs/Outputs

The dietary exposure and risk estimates are partially refined since they assume average

residues for most crops and include empirical processing factors. Additional refinements may be implemented such as the incorporation of %CT data , monitoring data, and inclusion of additional empirical processing factors. HED concludes that the chronic dietary exposure and risk estimates are not underestimated.

IX. Conclusions

Dietary risks for fluoxa strobin are below HED’s level of concern for dietary exposure

and risk. All infants < 1 year old are the most highly exposed population subgroup for chronic exposure, with risks estimates at 66 % of the cPAD

. Risks were lower for all other population subgroups, including the general U.S . population which utilized 3 0 % of

the cPAD

. The chronic dietary exposure assessment is not likely to underestimate

exposure.

X. List of Attachments

Attachment 1

. Fluoxastrobin Chronic Dietary Analysis Input File

- Food & Water

Attachment 2

. Fluoxas trobin Chronic Dietary Analysis Results

- Food & WaterFluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

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Page 9 of 13 

### Attachment 1. Fluoxastrobin Chronic Dietary Analysis Input File

- Food & Water

Filename: C: \ Documents and Settings \ MNEGUSSI \ My Documents \ DEEM Version

3.16 \ Fluoxastrobin \ MelonSorghum \ FLUOXASTROBIN_TOL +WATER_Jan2013.R08

Chemical: Fluoxastrobin RfD(Chronic): .015 mg/kg bw/day NOEL(Chronic): 1.5 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day
Date created/last modified: 02

- 27

- 2013/12:01:16 Program ver. 3.16, 03

- 08

- d

Comment: N ew Use Melon and Sorghum; new EDWC 137 ppb Refinement

- Rice, subgroup 4B, 9A, 9B, 13

- 07G, group 8,

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 0103015000 1CD Arrowroot, flour 0.010000 1.000 1.000

010301500 1 1CD Arrowroot, flour

- babyfood 0.010000 1.000 1.000 0103017000 1CD Artichoke, Jerusalem 0.010000 1.000 1.000

0103082000 1CD Cassava 0.010000 1.000 1.000

0103082001 1CD Cassava

- babyfood 0.010000 1.000 1.000 0103139000 1CD Dasheen, corm 0.010000 1.000 1.000 0103166000 1CD Ginger 0.010000 1.000 1.000 0103166001 1CD Ginger

- babyfood 0.010000 1.000 1.000 0103167000 1CD Ginger, dried 0.010000 1.000 1.000 0103296000 1C Potato, chips 0.010000 1.000 1.000 0103297000 1C Potato, dry (granules/ flakes) 0.010000 1.000 1.000

0103297 001 1C Potato, dry (granules/ flakes)

- b 0.010000 1.000 1.000 0103298000 1C Potato, flour 0.010000 1.000 1.000 0103298001 1C Potato, flour

- babyfood 0.010000 1.000 1.000 0103299000 1C Potato, tuber, w /peel 0.010000 1.000 1.000 0103299001 1C Potato, tuber, w/peel

- babyfood 0.010000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 0.010000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel

- babyfood 0.0100 00 1.000 1.000 0103366000 1CD Sweet potato 0.010000 1.000 1.000 0103366001 1CD Sweet potato

- babyfood 0.010000 1.000 1.000 0103371000 1CD Tanier, corm 0.010000 1.000 1.000

01033 87000 1CD Turmeric 0.010000 1.000 1.000 0103406000 1CD Yam, true 0.010000 1.000 1.000

0103407000 1CD Yam bean 0.010000 1.000 1.000

0402076000 4B Cardoon 2.090000 1.000 1.000 0402085000 4B Celery 2.090000 1.000 1.000 0402085001 4B Celery

- babyfood 2.090000 1.000 1.000 0402086000 4B Celery, juice 2.09 0000 1.000 1.000

0402087000 4B Celtuce 2.090000 1.000 1.000 0402152000 4B Fennel, Florence 2.090000 1.000 1.000

0402322000 4B Rhubarb 2.090000 1.000 1.000

040 2367000 4B Swiss chard 2.090000 1.000 1.000 0600347000 6 Soybean, seed 0.050000 1.000 1.000 0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.050000 1.000 1.000 0600350000 6 Soybean, oil 0.050000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.050000 1.000 1.000 0603348000 6C Soybean, flour 0. 050000 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 0.050000 1.000 1.000

0801374000 8A Tomatillo 0.203000 1.000 1.000

0801375000 8A Tomato 0.203000 1.000 1.000

0 801375001 8A Tomato

- babyfood 0.203000 1.000 1.000 0801376000 8A Tomato, paste 1.500000 1.000 1.000 0801376001 8A Tomato, paste

- babyfood 1.500000 1.000 1.000 0801377000 8A Tomato, pu ree 0.203000 1.000 1.000 0801377001 8A Tomato, puree

- babyfood 0.203000 1.000 1.000 0801378000 8A Tomato, dried 0.203000 14.300 1.000 0801378001 8A Tomato, dried

- babyfood 0.203000 14.300 1.000 0801379000 8A Tomato, juice 0.203000 1.500 1.000 0801380000 8A Tomato, Tree 0.203000 1.000 1.000 0802148000 8BC Eggplant 0.214000 1.000 1.000Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

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Page 10 of 13 0802234000 8BC Okra 0.214000 1.000 1.000 0802270000 8B Pepper, bell 0.214000 1.000 1.000 0802270001 8B Pepper, bell

- babyfood 0.214000 1.000 1.000 0802271000 8B Pepper, bell, dried 0.214000 1.000 1.000 0802271001 8B Pepper, bell, dried

- babyfood 0.214000 1.000 1.000 0802272000 8BC Pepper, nonbell 0.214000 1.000 1.000 0802272001 8BC Pepper, nonbell

- babyfood 0.214000 1.000 1.000 0802273000 8BC Pepper, nonbell, dried 0.214000 1.000 1.000 0901075000 9A Cantaloupe 0.282000 1.000 1.000 0901187000 9A Honeydew melon 0.282000 1.000 1.000

0901399000 9A Watermelon 0.282000 1.000 1.000 0901400000 9A Watermelon, juice 0.282000 1.000 1.000 0902021000 9B Balsam pear 0.090000 1.000 1.000 0902088000 9B Chayot e, fruit 0.080000 1.000 1.000 0902102000 9B Chinese waxgourd 0.090000 1.000 1.000

0902135000 9B Cucumber 0.090000 1.000 1.000 0902308000 9B Pumpkin 0.080000 1.000 1.000 0902309000 9B Pumpkin, seed 0.080000 1.000 1.000 0902356000 9B Squash, summer 0.080000 1.000 1.000 0902356001 9B Squash, summer

- babyfood 0.080000 1.000 1.0 00 0902357000 9B Squash, winter 0.080000 1.000 1.000 0902357001 9B Squash, winter

- babyfood 0.080000 1.000 1.000 1100173500 11 Goji berry 0.203000 1.000 1.000

1302057000 13B Blue berry 0.560000 1.000 1.000 1302057001 13B Blueberry

- babyfood 0.560000 1.000 1.000 1307130000 13G Cranberry 0.560000 1.000 1.000 1307130001 13G Cranberry

- babyfood 0.560000 1.000 1.000 1307131000 13G Cranberry, dried 0.560000 1.000 1.000 1307132000 13G Cranberry, juice 0.560000 1.100 1.000 1307132001 13G Cranberry, juice

- babyfood 0.560000 1.100 1 .000 1307359000 13G Strawberry 0.560000 1.000 1.000 1307359001 13G Strawberry

- babyfood 0.560000 1.000 1.000 1307360000 13G Strawberry, juice 0.560000 1.000 1.000

1307360001 13G St rawberry, juice

- babyfood 0.560000 1.000 1.000 1500120000 15 Corn, field, flour 0.020000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.020000 1.000 1.000 1500121000 15 Corn, field, meal 0.020000 1.000 1.000 1500121001 15 Corn, field, meal

- babyfood 0.020000 1.000 1.000 1500122000 15 Corn, field, bran 0.020000 1.000 1.000 1500123000 15 Corn, field, starch 0.020000 1.000 1.000 1500123001 15 Corn, field, starch

- babyfood 0.020000 1.000 1.000 1500124000 15 Corn, field, syrup 0.020000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.020000 1.500 1.000

1500125000 15 Corn, field, oil 0.020000 1.000 1.000 1500125001 15 Corn, field, oil

- babyfood 0.020000 1.000 1.000 1500127000 15 Corn, sweet 0.010000 1.000 1.000 DP#364

Full comment: DP#364445
1500127001 15 Corn, sweet

- babyfood 0.010000 1.000 1.000 1500323000 15 Rice, white 1.177000 1.000 1.000 DP# 39

Full comment: DP# 392986 1500323001 15 Rice, white

- babyfood 1.17700 0 1.000 1.000 DP# 39

Full comment: DP# 392986 1500324000 15 Rice, brown 1.177000 1.000 1.000 DP# 39

Full comment: DP# 392986
1500324001 15 Rice, brown

- babyfood 1.177000 1.000 1.000 DP# 39

Full comment: DP# 392986 1500325000 15 Rice, flour 1.177000 1.000 1.000 DP# 39

Full comment: DP# 392986 1500325001 15 Rice, flour

- babyfood 1.177000 1.000 1.000 DP# 39

Full comment: DP# 392986 1500326000 15 Rice, bran 1.177000 1.000 1.000 DP# 39

Full comment: DP# 392986 1500326001 15 Rice, bran

- babyfood 1.177000 1.000 1.000 DP# 39

Full commen t: DP# 392986 1500344000 15 Sorghum, grain 1.500000 1.000 1.000 1500345000 15 Sorghum, syrup 1.500000 1.000 1.000Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

___________________________________________________________________________________

Page 11 of 13 1500401000 15 Wheat, grain 0.150000 1.000 1.000

1500401001 15 Wheat, grain

- babyfood 0.150000 1.000 1.000 1500402000 15 Wheat, flour 0.150000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.150000 1.000 1.000 1500403000 15 Wheat, germ 0.150000 1.000 1.000 1500404000 15 Wheat, bran 0.150000 1.000 1.000

1500405000 15 Wild rice 1.177000 1.000 1.000 3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat

- babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 3100046000 31 Beef, meat byproducts 0.200000 1.000 1.000 DP#364

Full comment: DP#364445 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 3100048000 31 Beef, kidney 0.200000 1.000 1.000 DP#364

Full comment: DP#364445 3100049000 31 Beef, liver 0.200000 1.000 1.000 DP#364

Full comment: DP#364445

3100049001 31 Beef, liver

- babyfood 0.200000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.200000 1.000 1.000 DP#364

Full comment: DP# 364445 3200171000 32 Goat, fat 0.100000 1.000 1.000 3200172000 32 Goat, kidney 0.200000 1.000 1.000 DP#364

Full comment: DP#364445
3200173000 32 Goat, liver 0. 200000 1.000 1.000 DP#364

Full comment: DP#364445
3300189000 33 Horse, meat 0.050000 1.000 1.000 3400291000 34 Pork, skin 0.060000 1.000 1.000 DP#392

Full comment: DP#3 92986 3400292000 34 Pork, meat byproducts 0.060000 1.000 1.000 DP#392

Full comment: DP#392986 3400292001 34 Pork, meat byproducts

- babyfood 0.060000 1.000 1.000 DP#392

Full comment: DP#392986

3400293000 3 4 Pork, fat 0.030000 1.000 1.000 DP#392

Full comment: DP#392986
3400293001 34 Pork, fat

- babyfood 0.030000 1.000 1.000 DP#392

Full comment: DP#392986 3400294000 34 Pork, kidney 0.060000 1.000 1.000 DP#392

Full comment: DP#392986 3400295000 34 Pork, liver 0.060000 1.000 1.000 DP#392

Full comment: DP#392986 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.200000 1.000 1.000 DP#364

Full comment: DP#364445 3500341000 35 Sheep, fat 0.100000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.100000 1.000 1.000 3500342000 35 Sheep, kidney 0.200000 1.000 1.000 DP#364

Full comment: DP#364445

3500343000 35 Sheep, liver 0.200000 1.000 1.000 DP#364

Full comment: DP#364445 3600222000 36 Milk, fat 0.750000 1.000 1.000 3600222001 36 Milk, fat

- baby food/infant formu 0.750000 1.000 1.000
3600223000 36 Milk, nonfat solids 0.030000 1.000 1.000 3600223001 36 Milk, nonfat solids

- baby food/in 0.030000 1.000 1.000
3600224000 36 Milk, water 0.030000 1.000 1.000 3600224001 36 Milk, water

- babyfood/infant form 0.030000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.030000 1.000 1.000 4000094000 40 Chicken, liver 0.060000 1.000 1.000 DP#392

Full comment: DP#392986

50003 83000 50 Turkey, liver 0.060000 1.000 1.000 5000383001 50 Turkey, liver

- babyfood 0.060000 1.000 1.000 6000302000 60 Poultry, other, liver 0.060000 1.000 1.000 8601000000 86A Water, direct, all sources 0.137000 1.000 1.000Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

___________________________________________________________________________________

Page 12 of 13 8602000000 86B Water, indirect, all sources 0.137000 1.000 1.000
9500263000 O Peanut 0.020000 1.000 1.000 DP#364

Full comment: DP#364445

9500264000 O Peanut, butter 0.020000 1.890 1.000 DP#364

Full comment: DP#364445 9500265000 O Peanut, oil 0.060000 1.000 1.000 DP#364

Full comment: DP#364445Fluoxastrobin

PC Code: 028869 Dietary Exposure and Risk Assessment DP Number: 40 9517

___________________________________________________________________________________

Page 13 of 13 

### Attachment 2. Fluoxastrobin Chronic Dietary Analysis Results

- Food & Water

U.S. EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for FLUOXASTROBIN NHANES 20 03

- 2008 2

- day

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

3.16 \ Fluoxastrobin \ MelonSorghum \ FLUOXASTROBIN_TOL+WATER_Jan2013.R08 Adjustment factor #2 NOT used. Analysis Date 02

- 27

- 2013/12:02:10 Residue file dated: 02

- 27

- 2013/12:01:16 Reference dose (RfD, Chronic) = .015 mg/kg bw/day COMMENT 1: New Use Melon and Sorghum; new EDWC 137 ppb Refinement

- Rice, subgroup 4B,
9A, 9B, 13

- 07G, group 8,

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

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

Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

--------------------------- ----------- ------------- ---------------- Total US Population 0.004529 30.2% Hispanic 0.004667 31.1%

Non

- Hisp

- White 0.004547 30.3%

Non

- Hisp

- Black 0.003794 25.3%

Non

- Hisp

- Other 0.005687 37.9% Nursing Infants 0.003969 26.5%

Non

- Nursing Infan ts 0.012528 83.5%

Female 13+ PREG 0.004122 27.5%

Children 1

- 6 0.008050 53.7%

Children 7

- 12 0.00479 6 32.0%

Male 13

- 19 0.003476 23.2%

Female 13

- 19/NP 0.003554 23.7%

Male 20+ 0.004039 26.9% Female 20+/ NP 0.004214 28.1%

Seniors 55+ 0.003920 26.1%

All Infants 0.009886 65.9%

Female 13

- 50 0 .004116 27.4%

Children 1

- 2 0.009516 63.4%

Children 3

- 5 0.007496 50.0%

Children 6

- 12 0.005052 33.7%

Youth 13

- 19 0.003514 23.4%

Adults 20

- 49 0.004226 28.2%

Adults 50

- 99 0.003999 26.7%

Female 13

- 49 0.004118 27.5%