Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

PC Code: 119011

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### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION



### MEMORANDUM

DATE: 12 April 2011

SUBJECT: Flazasulfuron: Acute & Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the first food use, Section 3 Registration Action ( Citrus, Grapes and Sugarcane ).

PC Code: 119011 DP Barcode: 378629

Decision No.: 42525 3 Registration No. : 71512

- RI

Petition No.: 9F7666 Regulatory Action: Section 3 Registration Risk Assessment Type: Single Chemical/Aggregate Case No.: N/A

T XR No.: NA CAS No.: 104040

- 78

- 0

MRID No. : NA 40 CFR: 

### N/A

REVIEWER: Kristin Rury

, Biologist

R isk A ssessment B ranch 3 (RABIII) Health Effects Division ( HED; 7509P)

THROUGH: Thurston Morton

, Chemist

William Cutchin

, Chemist Dietary Exposure Science Advisory Council (DESAC)

HED (7509P)

and Paula Deschamp, Branch Chief

RABIII/HED (7509P)

TO: Linda Arrington , RM#25 Registration Division (7505P)

Executive Summary

Acute & c hronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model, DEEM

- FCIDTM, Version 2.03,

w hich uses food consumption data from the U.S. Department of Agriculture’s (USDA’s)Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994

- 1996 and 1998. The analysis was p erformed to support a Section 3 request for flazasulfuron in/ on citrus, grapes and

sugarcane

.

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

Tolerance level residues combined with 100% crop treated were used to determine the acute dietary exposure and risk estimates. Drinking water was inc orporated directly into the dietary

assessment. The acute dietary exposure estimates for food and drinking water are below HED’s level of concern for the general U.S. population ( 1 % of the acute population adjusted dose (aPAD)). The most highly exposed population subgroup was all infants (<1 year old) ( 4 % of the aPAD).

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

Tolerance level residues co mbined with 100% crop treated were used to determine the chronic dietary exposure and risk estimates. Drinking water was incorporated directly into the dietary

assessment. Th e chronic dietary exposure estimates for food and drinking water are below

HED’s level of concern for the general U.S. population ( 17 % of the chronic population adjusted dose (cPAD) ). The most highly exposed population subgroup was all infants (<1 year old) (54 % of the cPAD )

.

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

Fl azasulfuron is classified as “not likely to be carcinogenic to humans ,” so a cancer dietary

assessment was not conducted

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 dos e (PAD). The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety

factors.

For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary risk

exceeds 100% of the PAD. HED i s generally concerned when estimated cancer risk exceeds

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

- JUN

- 2000, web link: http://www.epa.gov/fedrgstr/EPA

- PEST/2000/July/Day

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

- AUG

- 1999).

This is the first dietary exposure analysis for flazasulfuron.Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### II. Residue Information

Flazasulfuron U se:

For the current action, HED has examined data to support the establishment of tolerances in/on citrus, grapes and sugarcane.

Metabolism studies on grape, sugarcane, and tomato were evaluated by EPA’s Residues of Concern Knowledgebase Subcommittee (ROCKS) on 2/15/11. Based on the available information, the ROCKS determined that the residue of concern for plants for both the

tole rance expression and risk assessment is parent. This conclusion is based on the fact that no residues of parent or 1

- (4,6

- dimethoxypyrimidin

- 2

- yl)

- 1

- (3

- trifluoromethyl

- 2

- pyridyl)urea ( DTPU ) were found in any field trials.

The goat metabolism study was evaluated by the ROCKS on 2/15/11. Pending receipt of additional information on the goat metabolism study, an acceptable goat metabolism study is available. The major metabolites identified in kidney, liver and/or muscle inc luded the parent (flazasulfuron), 4

- hydroxy

- 6

- methoxy

- 2

- (3

- trifluoromethyl

- 2

- pyridylamino)pyrimidine ( HTPP ) , and DTPU. 4,6

- dimethoxy

- 2

- (3

- trifluoromethyl

- 2

- pyridylamino)pyrimidine ( DTPP ) was identified as a minor metabolite only. The petitioner indicated that flazasulfuron undergoes not only loss of the sulfonyl moiety and rearrangement to form DTPU, DTPP, and HTPP, but is further metabolized and excreted as HTPU glucuronide, HTPP glucuronide (TPPG), HDTP glucuronide (HDTG), and HTPP + O

- glucuronide. Chr omatographic analysis showed that the radioactivity extracted from a tissue type was consistent regardless of label position and yielded little evidence of cleavage of the parent molecule by the goat, elimination of the sulfonyl moiety and reconnection of the urea bridge notwithstanding. Based on the available information, the ROCKS determined for the proposed uses that the residue of concern for ruminants for both the tolerance expression and risk assessment is parent. There is

no concern with metabolites because of the low dietary burden associated with the proposed

uses.

An adequate residue analytical method using high performance liquid chromatography/tandem mass spectrometry with multiple reaction monitoring (HPLC/MS

- MS/MRM) (ADME study

code S09

- 0310 6; MRID 48092201) is available for enforcing the proposed tolerances. The method underwent a successful independent laboratory validation (ILV) using olives, tomatoes, and wheat. The validated limit of quantitation (LOQ) is 0.01 ppm. Radiovalidation

is not needed since the extraction solvent is the same (acetonitrile:water, 80:20, v/v) in the method (MRID 48092201) and in the grape, sugarcane, and tomato metabolism studies (MRIDs 47939905, 47939906, and 47939907, respectively).

Residue Data Used for Acu te & Chronic Assessments

HED’s recommended tolerance levels for citrus, grapes and sugarcane ( listed below) were

used to conduct the dietary analyse s.Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### Tolerances to be established “ General”:

Citrus

................................ ................................ ...... 0.0 1 ppm Grapes

................................ ................................ .... 0. 0 1 ppm Sugarcane

................................ ............................... 0.01 ppm

Processing factors for parent flazasulfuron could not be calculated for any of the processed commodities because no quantifiable residues of parent occurred. Therefore, separate tolerances are not required for the processed commodities of citrus (oil, jui ce, and dried pulp), grape (juice and raisin), and sugarcane (molasses and refined sugar) (N. Dodd, D372901, 2/16/11). No DEEMTM 7.81 processing factors were used in the dietary exposure assessment.
However, 100% crop treated assumptions were used to c onduct the acute and chronic analys e s.

III. Drinking Water Data

The drinking residues used in the dietary assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memorandum: “ Flazasulfuron: Refined Drinking Water Asse ssment for First Food Uses on citrus, grapes and sugarcane, and new

outdoor non

- food uses on Christmas trees and industrial vegetation management ” ( A. Shelby

, D372897, 4/4/11 ) and were incorporated directly into this dietary assessment. Water residues

wer e incorporated in the DEEM Food Commodity Intake Database ( FCID ) into the food categories “water, direct, all sources” and “water, indirect, all sources.”

For surface water

, Estimated Drinking Water Concentrations ( EDWCs ) were generated from

the Pesticide Root Zone Model and Exposure Analysis Modeling System ( PRZM

- EXAMs )

. For groundwater, EDWGs were generated from a Tier II provisional groundwater model (PRZM

- GW).

PRZM GW is a graphical user interface that automates the Pesticide Root Zone Mod el (PRZM v3.12.2; May 12, 2005; Suarez, 2006) under a NAFTA

- harmonized conceptual model for ground water modeling that was subject to peer review by the FIFRA SAP (USEPA, 2005; 2005a). The conceptual model represents vulnerable private drinking water well s in the vicinity of agricultural environments. In this conceptualization, the pesticide is applied to the soil surface (or plant canopy) and precipitation or irrigation drives the pesticide into the soil. Meteorological, crop, biological, chemical, and management processes affect the transport of the pesticide as it moves through the soil and into a saturated zone. Horizontal movement of pesticide (advection via runoff or erosion) and subsequent removal is neglected for this model.

The saturated zone o f the conceptual model is a shallow surficial aquifer with a water table nine meters below the surface. Concentrations are based on a vertical spatial average starting at the top of the water table down to a depth of 1 meter below the water table. This i s meant to approximate the vertical depth from which a well screen may sample and supply as drinkingFlazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### water. The location of the well screen was chosen to sample the higher concentrations expected nearer to the water table.

The conceptual model includes m eteorological events with daily resolution that can significantly affect pesticide transport including precipitation, evaporation, snow, temperature, and wind. Crop descriptions are needed only in regard to how they impact hydrology or pesticide intercept ion. Management practices such as irrigation and setback distances are included in the conceptual model. The default environmental fate scheme uses the aerobic soil degradation rate in the top 10 cm and a linearly declining rate with depth to 1 meter, be low which only hydrolysis is assumed to occur.

Based on refined modeling results using the provisional Tier II groundwater model (PRZM

GW), estimated groundwater exposure concentration for total toxic residues of flazasulfuron for new and expanded uses is 102 ppb for acute and chronic exposure. The estimated drinking water exposure concentration was generated from the Delmarva corn scenario which represents new uses on grapes, Christmas trees and industrial vegetation management. Dietary exposure and ris k estimates were determined using the refined, Tier II provisional groundwater model estimates (PRZM

- GW).

Tier I model results in only a single screening level concentration to be used for assessing risk at all exposure durations. Tier II modeling allo ws for the estimation of exposure concentrations at various exposure durations, however, because the Tier II groundwater model is provisional, this assessment will conservatively assume the peak concentration represents all exposure durations.

The surfa ce and ground water EDWCs are shown in Table 1

.

Th e drinking water assessment differs from previous drinking water assessments on flazasulfuron and reports higher EDWCs because of the inclusion of nonextracted residues in

metabolism studies. Nonextracte d residues are likely to be parent flazasulfuron or degradates

included as total toxic residues ( TTR ) . Data characterizing adsorption/desorption behavior of degradates and metabolism studies with more rigorous extraction techniques would reduce uncertainty associated with nonextracted residues. Excluding nonextracted residues from

half

- life calculations reduces EDWCs by less than 1% to 9% for scenarios resulting in highest crop and non

- crop EDWCs (CA impervious and LA sugarcane). Assuming the K

oc 

### of flazasulfuron represents the mobility of all degradates reduces the acute and chronic groundwater EDWC by 94% according to SCIGROW. Adsorption/desorption and toxicity data for degradates would be of most use to reduce uncertainty with the TTR approa ch.Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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Page 6 of 13 Table 1. Summary of Estimated Surface Water and Groundwater Concentrations for Flazasulfuron

.
Surface Water Conc., ppb a Tier II Groundwater Conc., ppb b

Acute 26.9 102 Chronic (non

- cancer, 1 in 10 year annual average) 4.67

a From the Tier I PRZM

- EXAMs modeling system

. b From the Tier II provisional groundwater model (PRZM

- GW).



### IV. DEEM

- FCIDTM Program and Consumption Information

Flazasulfuron acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database

DEEM

- FCIDTM,Version 2.03 which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994

- 1996 and 1998. The 1994

- 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non

consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA

- defined food commodities (e. g. apples, peeled fruit

- cooked; fresh or N/S; baked; or wheat flour

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged

fo r the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on analysis of the 1994

- 96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1

- 2, children 3

- 5,

children 6

- 12, youth 13

- 19, adults 20

- 49, females 13

- 49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that fo od/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 estimat ed exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD. This procedure is performed for each population subgroup.

For acute exposure assessments, individual one

- day food consumption data are used on an

individual

- by

- ind ividual 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

re sidue values and them 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 the relevant commodities/food forms) and a per capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for tiers 1Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### and 2, any significant differences in user vs . per capita exposure and risk are specifically

identified and noted in the risk assessment.

V. Toxicological Information

The doses and endpoints for dietary risk assessment were selected by the fluzasulfuron risk assessment team. A summary of this information is presented in Table 2

. Flazasulfuron has been classified as “not likely to be carcinogenic to humans

. ” A quantitative carcinogenic dietary analysis is not required.

Chronic oral studies in the rat and the dog indicate that the kidney and liver are the target organs for chronic oral exposure. Subchronic oral studies indicate decreased body weight gain, slight anemia in rats and liver abnormalities in dogs. The available data for flazasulfuron

did not show neurotoxic, carcinogenic or mutagenic effects.

Developmental toxicity was observed in rats and rabbits. Reduced fetal weights and retardation in ossification were observed in a Sprague

- Dawley rat developmental study. A Wistar rat developmenta l study showed increased incidence of visceral malformations (interventricular septal defect). The rabbit developmental study showed high incidences of abortion at the highest dose tested. Decreases in body weight and chronic neuropathy were

observed in the offspring in a 2

- generation rat reproduction study. The effects on offspring in these developmental and reproductive studies occurred at dose levels which were toxic to the parents, and susceptibility concerns were not raised.

Neurotoxicity was obs erved using an acute neurotoxicity battery. A transient decrease in motor activity on Day 0 (5 hours post dosing) was observed at the mid

- dose of 1,000 mg/kg.

The genotoxic potential of flazasulfuron has been assessed as negative by several in vitro an d

in vivo mutagenicity studies. The two

- year combined chronic toxicity and carcinogenicity study showed no evidence of carcinogenicity.

Flazasulfuron exhibits low acute toxicity in rats and rabbits. The oral LD 50 

### is greater than 5,000 mg/kg, the acute inhalation LD 50 

### is greater than 4.0 mg/L, and the acute dermal LD 50 

### is greater than 2,000 mg/kg. All studies are in Toxicity Category III or IV.

Based on the hazard and exposure data, the flazasulfuron risk assessm ent team has recommended that the Food Quality Protection Act (FQPA) Safety Factor be reduced to 1X. There are no quantitative susceptibility concerns based on the developmental and rep roductive

studies.

The selection of toxicity endpoints and points o f departure is presented in the previous risk assessment ( G. Burke, D303573

, 11/16/ 0 5), and are unchanged for this risk assessment. They

are summarized in Table 2

.Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### A separate a cute d ietary endpoint for Females 13

- 49 was not selected from the available

de velopmental toxicity studies because the NOAEL of 50 mg/kg from the a cute n eurotoxicity study is the lowest NOAEL for any available acute study, and is protective of the developmental effects seen in the prenatal developmental (Wistar) rat study with a NOA EL of 100 mg/kg/day and a LOAEL of 300 mg/kg/day. Therefore, a separate endpoint for females

13

- 49 based on developmental effects is not considered necessary.

The doses and toxicological endpoints selected for various exposure scenarios are summarized

b elow.

Table 2

. Summary of Toxicological Doses and Endpoints for Flazasulfuron for Use in Residential and Non

Occupational Human Health Risk Assessments

Exposure/

Scenario Point of Departure Uncertainty/FQ PA Safety

Factors RfD, PAD,

Level of

Concern for

Risk

Assessment Study and Toxicological Effects

Acute Dietary ( all populations including

Females 13

- 49 ) NOAEL =50 mg/kg UF A = 10x

UF H = 10x FQPA SF = 1X Acute RfD = 0.5 mg/kg

aPAD = 0.5 mg/kg Acute neurotoxicity (rat) LOAEL = 1000 mg/kg based on: transient decrease in motor activity observed at Day 0 (5 hours post

dosing).

Chronic Dietary (all popu

lations) Oral

NOAEL =

1.3 mg/kg/day UF A = 10x

UF H = 10x FQPA SF = 1X Chronic RfD = 0.013 mg/kg /day

cPAD = 0.013 mg/kg /day Combined Chronic Toxicity/ Carcinogenicity rats LOAEL= 13.3 mg/kg/day based on: Adverse change in kidney function (chronic nephropathy)

Cancer (oral, dermal, inhalation) Classification: No evidence of carcinogenicity to humans based on lack of carcinogenic effects in the rat and mouse carcinogenicity studies and lack of a mutagenicity concern

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. UF A = extrapolation from animal to human (intraspecies). UF H = potential v ariation in sensitivity among members of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (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

- FCIDTM analyses estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table s 3 and 4 are for the general U.S. popul ation, 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.

Results of Acute Dietary (Food and Drinking Water) Exposure AnalysisFlazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### The results of the acute dietary (food + d rinking water) exposure analysis at the 95 th 

### percentile of exposure are reported in Table 3. The flazasulfuron acute dietary risk estimates for food and drinking water using the Delmarva corn scenario for drinking water are all below HED’s

level of concer n (<100% aPAD) at the 95 th 

### percentile of exposure for the general U.S. population and all population subgroups, at 1 % aPAD for the general U.S. population and 4 % aPAD for all infants (<1 year old), the most highly exposed subgroup.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

Tolerance level residues

, 100 % CT , and DEEM TM 

### 7.81 default processing factors were used to determine the chronic dietary exposure and risk estimates. This assessment showed that for all

included commodi ties, the chronic risk estimates were below the Agency’s level of concern (<100% cPAD) for the general U.S. population ( 1 7 % of the cPAD) and all population subgroups ( < 54 % cPAD ) listed in Table 3

. The most highly exposed population subgroup w as all infant s (<1 year old) at 54 % of the cPAD.

Table 3. Summary of Dietary (Food and Drinking Water) Exposure Analysis for Flazasulfuron Using DEEM

- FCID

Population Subgroup Acute Dietary ( 95 th Percentile ) Chronic Dietary

Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % c PAD

General U.S. Population 0. 005365 1 0. 002173 17
All Infants (< 1 year old) 0. 020058 4 0.007 068 54

Children 1

- 2 years old 0. 008418 2 0.003 278 25

Children 3

- 5 years old 0. 007707 2 0.003 055 2 4

Children 6

- 12 years old 0 .005343 1 0.002 099 16

Youth 13

- 19 years old 0.004388 <1.0 0.001 575 12

Adults 20

- 49 years old 0.00 4948 <1.0 0.002 023 16 Adults 50+ years old 0.00 4475 <1.0 0.002 129 16

Females 13

- 49 years old 0.00 4979 1 0.002 016 1 6



### VII. Characterization of Inputs/Outputs

As the exposure estimates to all po pulation subgroups were low

, it was not necessary to make

refinements to the acute and chronic dietary analyses

. Further refinement to the analysis could be made through the use of percent crop treated , a nticipated residues, empirical processing factors, and/or monitoring data

.

VII I . Conclusions

Based on extremely conservative assumptions, the acute and chronic dietary (food and water) risk estimates are well below HED’s level of concern for the general U.S. population and all population subgroups, including those comprised of infants and children.Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### IX. List of Attachments

Attachment 1 : Acute & Chronic Food and Water Residue Input File.

Attachment 2 : Acute Results File.

Attachment 3: Chronic Results File

.Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### Attachment 1 : Acute & Chronic Food and Water Residue Input file

U.S. Environmental Protection Agency Ver. 2.02

DEEM

- FCID Acute analysis for FLAZASULFURON

Residue file name: C: \ Documents and Settings \ krury \ My Documents \ My Work

Files \ Flazasulfuron \ Flaz Citrus Grape Sugarcane.R98 Analysis Date 04

- 04

- 2011 Residue file dated: 03

- 30

- 2011/13:33:00/8
Reference dose: aRfD = 0.5 mg/kg bw/day NOEL = 50 mg/kg bw/day

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

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

-------- ---- ------------------------------- ---------- ---- -- ------ ------- 10001060 10 Citrus citron 0.010000 1.000 1.000 10001070 10 Citrus hybrids 0.010000 1.000 1.000
10001080 10 Citrus, oil 0.010000 1.000 1.000

95001750 O Grape 0.010000 1.000 1.000 95001760 O Grape, juice 0.010000 1.000 1.000 95001761 O Grape, juice

- babyfood 0.010000 1.000 1.000
95001770 O Grape, leaves 0. 010000 1.000 1.000 95001780 O Grape, raisin 0.010000 1.000 1.000 95001790 O Grape, wine and sherry 0.010000 1.000 1.000 10001800 10 Grapefruit 0.010000 1.000 1.000

10001810 10 G rapefruit, juice 0.010000 1.000 1.000
10001970 10 Kumquat 0.010000 1.000 1.000

10001990 10 Lemon 0.010000 1.000 1.000 10002000 10 Lemon, juice 0.0 10000 1.000 1.000 10002001 10 Lemon, juice

- babyfood 0.010000 1.000 1.000
10002010 10 Lemon, peel 0.010000 1.000 1.000

10002060 10 Lime 0.010000 1.000 1.000

10002070 10 Li me, juice 0.010000 1.000 1.000 10002071 10 Lime, juice

- babyfood 0.010000 1.000 1.000
10002400 10 Orange 0.010000 1.000 1.000 10002410 10 Orange, juice 0.01 0000 1.000 1.000 10002411 10 Orange, juice

- babyfood 0.010000 1.000 1.000
10002420 10 Orange, peel 0.010000 1.000 1.000

10003070 10 Pummelo 0.010000 1.000 1.000
95003620 O Sug arcane, sugar 0.010000 1.000 1.000
95003621 O Sugarcane, sugar

- babyfood 0.010000 1.000 1.000
95003630 O Sugarcane, molasses 0.010000 1.000 1.000
95003631 O Sugarcane, molasses

- babyfood 0.010 000 1.000 1.000 10003690 10 Tangerine 0.010000 1.000 1.000 10003700 10 Tangerine, juice 0.010000 1.000 1.000
86010000 O Water, direct, all sources 0.102000 1.000 1.000

86020000 O Water, indirect, all sources 0.102000 1.000 1.000Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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### Attachment 2 : Acute Results File

U.S. Environmental Protection Agency Ver. 2.02

DEEM

- FCID ACUTE Analysis for FLAZASULFURON (1994

- 98 data) Residue file: Flaz Citrus Grape Sugarcane.R98 Adjustment factor #2 NOT used. Analysis Date: 03

- 30

- 2011/13:41:02 Residue file dated: 03

- 30

- 2011/13:33:00/8
NOEL (Acute) = 50.000000 mg/kg body

- wt/day Daily totals for food and foodform consumptio n used.

Run Comment: ""

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

Summary calculations (per capita):

95th Percentile 99th Percentile 99.9th Percentile
Exposure % aRfD MOE Exposu re % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- U.S. Population:

0.005365 1.07 9319 0.010048 2.01 4976 0.020088 4.02 2489

All infants:

0.020058 4.01 2492 0.028750 5.75 1739 0.051500 10.30 970

Children 1

- 2 yrs:

0.008418 1.68 5939 0.014270 2.85 3503 0.020746 4.15 2410

Children 3

- 5 yrs:

0.007707 1.54 6487 0.012081 2.42 4138 0.019632 3.93 2546

Children 6

- 12 yrs:

0.005343 1.07 9358 0.008926 1.79 5601 0.012202 2.44 4097

Youth 13

- 19 yrs:

0.004388 0.88 11395 0.007285 1.46 6863 0.013102 2.62 3816

Adults 20

- 49 yr s:

0.004948 0.99 10104 0.008266 1.65 6048 0.014952 2.99 3343
Adults 50+ yrs:

0.004475 0.89 11174 0.006393 1.28 7820 0.010511 2.10 4756

Females 13

- 49 yrs:

0.004979 1.00 10041 0.007976 1.60 6268 0.014189 2.84 3523Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

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Page 13 of 13 Attachment 3 : Chronic Results File

U.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chronic analysis for FLAZASULFURON (1994

- 98 data)

Residue file name: C: \ Documents and Settings \ krury \ My Documents \ My Work

Files \ Flazasulfuron \ Flaz Citrus Grape Sugarcane.R98 Adjustment factor #2 NOT used. Analysis Date 04

- 04

- 2011/12:05:46 Residue file dated: 03

- 30

- 2011/13 :33:00/8 Reference dose (RfD, Chronic) = .013 mg/kg bw/day

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

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

Total Exposure

----------------------------------- Population mg/kg Percent of

Su bgroup body wt/day Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.002173 16.7%

U.S. Population (spring season) 0.002155 16.6% U.S. Population (summer season) 0.002332 17.9% U.S. Population (autumn season) 0.002101 16.2% U.S. Population (winter season) 0.002104 16.2%

Northeast region 0.001990 15.3% Midwest region 0.002196 16.9% Southern region 0.002064 15.9% Western region 0.002487 19.1%

Hispanics 0.002468 19.0%

Non

- hispanic whites 0.002120 16.3%

Non

- hispanic blacks 0.002066 15.9%

Non

- hisp/non

- white/non

- black 0.002662 20.5%

All infants (< 1 year) 0.007068 54.4% Nursing infants 0.002622 20.2%

Non

- nursing infants 0.008755 67.3%

Children 1

- 6 yrs 0.003073 23.6%

Children 7

- 12 yrs 0.001989 15.3%

Females 13

- 19 (not preg or nursing) 0.001533 11.8% Females 20+ (not preg or nursing) 0.002163 16.6%

Females 13

- 50 yrs 0.002099 16.1% Females 13+ (preg/not nursing) 0.002110 16.2%
Females 13+ (nursi ng) 0.002999 23.1%

Males 13

- 19 yrs 0.001603 12.3%
Males 20+ yrs 0.001942 14.9%

Seniors 55+ 0.00212 8 16.4%

Children 1

- 2 yrs 0.003278 25.2%

Children 3

- 5 yrs 0.003055 23.5%

Children 6

- 12 yrs 0.002099 16.1%

Youth 13

- 19 yrs 0.001575 12.1%

Adults 20

- 49 yrs 0.002023 15.6%
Adults 50+ yrs 0.002129 16.4%

Females 13

- 49 yrs 0.002016 15.5%

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