Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 378629

PC Code: 119011

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1

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.: 425253 Registration No.: 71512-RI

Petition No.: 9F7666 Regulatory Action: Section 3 Registration

Risk Assessment Type: Single Chemical/Aggregate Case No.: N/A

TXR No.: NA CAS No.: 104040-78-0

MRID No.: NA 40 CFR: N/A

REVIEWER: Kristin Rury, Biologist

Risk Assessment Branch 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 & chronic aggregate dietary (food and drinking water) exposure and risk assessments 

were conducted using the Dietary Exposure Evaluation Model, DEEM-FCIDTM, Version 2.03, 

which 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 performed 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 incorporated 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 combined with 100% crop treated were used to determine the chronic 

dietary exposure and risk estimates. Drinking water was incorporated directly into the dietary 

assessment. The 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

Flazasulfuron 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 dose (PAD). The PAD is equivalent to 

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

factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

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

one in one million. References which discuss the acute and chronic risk assessments in more 

detail are available on the EPA/pesticides web site: “Available Information on Assessing 

Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link: 

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 Use:

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 

tolerance 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 included 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. Chromatographic 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 S09-03106; 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 Acute & Chronic Assessments

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

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

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Tolerances to be established “General”:

Citrus...................................................................... 0.01 ppm

Grapes.................................................................... 0.01 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, juice, 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 conduct the acute and chronic analyses.

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 Assessment 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 

were 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 Model (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 wells 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 of 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 is meant to 

approximate the vertical depth from which a well screen may sample and supply as drinking 
Flazasulfuron 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 meteorological 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 interception. 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, below 

which only hydrolysis is assumed to occur.

Based on refined modeling results using the provisional Tier II groundwater model (PRZMGW), 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 risk 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 allows 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 surface and groundwater EDWCs are shown in Table 1. 

The 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. Nonextracted 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 Koc 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 approach. 
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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 nonconsecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA-defined 

food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour -

cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly 

by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged 

for the entire U.S. population and within population subgroups, but for acute exposure 

assessment are retained as individual consumption events. Based on analysis of the 1994-96, 

98 CSFII consumption data, which took into account dietary patterns and survey respondents, 

HED concluded that it is most appropriate to report risk for the following population 

subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, 

children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake 

estimate. The resulting residue intake estimate for each food/food form is summed with the 

residue intake estimates for all other food/food forms on the commodity residue list to arrive at 

the total average estimated exposure. Exposure is expressed in mg/kg body weight/day and as 

a percent of the cPAD. This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food item can be 

multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure 

for a deterministic exposure assessment, or “matched” in multiple random pairings with 

residue values and 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 1 
Flazasulfuron 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 developmental 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 observed 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 and 

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 LD50 is greater than 

5,000 mg/kg, the acute inhalation LD50 is greater than 4.0 mg/L, and the acute dermal LD50 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 assessment 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 reproductive 

studies. 

The selection of toxicity endpoints and points of departure is presented in the previous risk 

assessment (G. Burke, D303573, 11/16/05), and are unchanged for this risk assessment. They 

are summarized in Table 2.
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A separate acute dietary endpoint for Females 13-49 was not selected from the available 

developmental toxicity studies because the NOAEL of 50 mg/kg from the acute neurotoxicity 

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 NOAEL 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 

below. 

Table 2. Summary of Toxicological Doses and Endpoints for Flazasulfuron for Use in Residential and NonOccupational 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

UFA = 10x

UFH = 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 postdosing).

Chronic 

Dietary

(all populations)

Oral

NOAEL = 

1.3 

mg/kg/day

UFA = 10x

UFH = 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. UFA = 

extrapolation from animal to human (intraspecies). UFH = potential variation 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 Tables 3 and 4 are 

for the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-

12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years. 

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

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The results of the acute dietary (food + drinking water) exposure analysis at the 95th 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 concern (<100% aPAD) at the 95th 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 DEEMTM 7.81 default processing factors were used to 

determine the chronic dietary exposure and risk estimates. This assessment showed that for all 

included commodities, the chronic risk estimates were below the Agency’s level of concern 

(<100% cPAD) for the general U.S. population (17% of the cPAD) and all population 

subgroups (<54% cPAD) listed in Table 3. The most highly exposed population subgroup was

all infants (<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 

(95th Percentile) Chronic Dietary

Dietary Exposure 

(mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD

General U.S. Population 0.005365 1 0.002173 17

All Infants (< 1 year old) 0.020058 4 0.007068 54

Children 1-2 years old 0.008418 2 0.003278 25

Children 3-5 years old 0.007707 2 0.003055 24

Children 6-12 years old 0.005343 1 0.002099 16

Youth 13-19 years old 0.004388 <1.0 0.001575 12

Adults 20-49 years old 0.004948 <1.0 0.002023 16

Adults 50+ years old 0.004475 <1.0 0.002129 16

Females 13-49 years old 0.004979 1 0.002016 16

VII. Characterization of Inputs/Outputs

As the exposure estimates to all population 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, anticipated residues, empirical processing 

factors, and/or monitoring data.

VIII. 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.
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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.
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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 Grapefruit, 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 0.010000 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 Lime, 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 0.010000 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 Sugarcane, 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 0.010000 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 1.000
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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 consumption used.

Run Comment: ""

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

Summary calculations (per capita):

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD MOE Exposure % 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 yrs:

 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 3523 
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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 

 Subgroup 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+ (nursing) 0.002999 23.1%

Males 13-19 yrs 0.001603 12.3%

Males 20+ yrs 0.001942 14.9%

Seniors 55+ 0.002128 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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