Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419 

PC Code: 119011 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: February 5, 2014 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Flazasulfuron: Acute & Chronic Aggregate Dietary (Food and Drinking 

Water) Exposure and Risk Assessment for a Proposed New Use on Tree Nuts. 

PC Code: I 19011 

Decision No.: 478042 

Petition No.: 3F8173 

DP Barcode: 417419 

Registration No.: 71512-18 

Regulatory Action: Section 3 Registration 

Risk Assessment Type: Dietary Case No.: N/A 

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

MRIDNo.: NA 40 CFR: § 180.655 

REVIEWER: 

THROUGH: 

TO: 

Cassi Walls, Senior Biologist ~ -:t_ L)~ Risk Assessment Branch 3 (RABBI) 

Health Effects Division (HED; 7509P) 

Dennis 

Meheret 

McNeilly

Negussie, 

, Chemist 

Chemist 

~ /ieAerd tw{- WZ ;::,_. ~ 

Dietary Exposure Science Advisory Council (DESAC) 

~n~D (7509P) tit~t/ / / 

Christine 

RABIIIIHED 

Olinger

(7509P) 

, Branch Chief 

. 

; 

f' 

J ~ 

Kable Davis/Emily Hartman, 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 software with the Food 

Commodity Intake Database (DEEM-FCID) Version 3. 16, which uses food consumption data 

from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, 

What We Eat in America (NHANES/WWEIA). This dietary survey was conducted from 2003 

to 2008. The analysis was performed to support a registration request for use of tlazasulfuron 

Page 1 of 16 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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on tree nuts. This memorandum was reviewed by two peer reviewers of the DESAC per 

DESAC SOP 2012.1. 

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

Tolerance-level residues of the currently registered and proposed crops 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) at 3% of the aPAD. 

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

Tolerance-level residues of the currently registered and proposed crops 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 [9% of the chronic population adjusted dose (cPAD)]. The most highly exposed 

population subgroup was all infants (<1 year old) at 23% of the cPAD. 

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

Flazasulfuron is classified as “not likely to be carcinogenic to humans,” therefore, 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).

The most recent dietary risk assessment for flazasulfuron was conducted by C. Walls 

(09/12/12, DP405650).
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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II. Residue Information

Flazasulfuron Use:

ISK Biosciences Corporation (ISK) has submitted an application to modify the Flazasulfuron 

Herbicide label (EPA Reg. No. 71512-18) to include a use on tree nuts (Group 14-12).

There are currently existing tolerances for flazasulfuron on citrus, grapes, and sugarcane 

established under 40 CFR §180.655.

Metabolism studies on grape, sugarcane, and tomato were evaluated by EPA’s Residues of 

Concern Knowledgebase Subcommittee (ROCKS) on 2/15/11 (D386767). 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 only. 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. Since no detectable residues of parent or 

DTPU were found in nutmeats or almond hulls in the tree nut field trials, this conclusion can 

be extended to tree nuts.

The goat metabolism study was also evaluated by the ROCKS on 2/15/11 (D386767). Based 

on the available information, the ROCKS determined for that the residue of concern for 

ruminants for both the tolerance expression and risk assessment is parent. 

Residue Data Used for Acute & Chronic Assessments

The existing tolerance levels for citrus, grapes and sugarcane (listed below) were used to 

conduct the dietary analyses. 

Established Tolerances “General”:

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

Grapes.................................................................... 0.01 ppm

Sugarcane............................................................... 0.01 ppm

Additionally, HED’s recommended tolerance of 0.01 ppm for tree nuts (group 14-12) was also 

used in the dietary analyses.

There are no processed commodities associated with the proposed tree nut use. For the 

existing uses, processing factors for parent flazasulfuron could not be calculated for any of the 

processed commodities because no quantifiable residues of parent were measured. Therefore, 

separate tolerances were not required for the processed commodities of citrus (oil, juice, and 

dried pulp), grape (juice and raisin), and sugarcane (molasses and refined sugar) and the 

processing factor was set to 1 for these commodities (N. Dodd, D372901, 2/16/11). No 

DEEMTM 7.81 processing factors were used in the dietary exposure assessment. 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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III. Percent Crop Treated Information

100% crop treated assumptions were used to conduct the acute and chronic analyses. 

IV. 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: “Drinking Water Assessment for 

Flazasulfuron Use on Tree Nuts” (A. Shelby, D411771, 12/3/13) 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, EDWCs were generated from a Tier II provisional groundwater model 

(PRZM-GW). EDWCs include total toxic residues of flazasulfuron in accordance with the 

most recent ROCKS memo (D386767, 2/15/11). The toxic residues include DTPU, DTPP, 

HTPP, TPSA, ADMP, and 2,3-GTF.

EFED conducted a drinking water assessment to support ISK’s previous submission for 

flazasulfuron use on citrus, grapes, sugarcane and for industrial vegetation management 

(D372897). The maximum application rate and maximum number of applications considered 

in the previous drinking water assessment (0.045 lb a.i./A with 3 applications per year) is 

protective of the maximum application rate and the maximum number of applications for the

proposed tree nuts new use (0.045 lb a.i./A with 2 applications per year). Further, PRZM 

scenarios representing use on tree nuts (Florida citrus, Florida nursery, New Jersey nursery, 

and Tennesse nursery) were also considered in the previous assessment. For these reasons, 

EFED does not find reason to change previous EDWCs and maintains an acute value of 90.8 

ppb and a chronic value of 55.6 ppb may be used to represent EDWCs for the new use on tree 

nuts. 

The surface and groundwater EDWCs are shown in Table 1. 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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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 90.8

(highest daily value)

Chronic 4.67

(non-cancer, 1 in 10 year annual average)

55.6

(post breakthough average)

a From the Tier I PRZM-EXAMs modeling system.

b From the Tier II provisional groundwater model (PRZM-GW). 

V. DEEM-FCIDTM Program and Consumption Information

Flazasulfuron acute and chronic dietary exposure assessments were conducted using the 

DEEM-FCID, Version 3.16, which incorporates consumption data from USDA’s 

NHANES/WWEIA. This dietary survey was conducted from 2003 to 2008. The data are 

based on the reported consumption of more than 20,000 individuals over two non-consecutive 

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

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

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

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

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

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

analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns 

and survey respondents, HED concluded that it is most appropriate to report risk for the 

following population subgroups: the general U.S. population, all infants (<1 year old), children 

1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ 

years old.

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

food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by 

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

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

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

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

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

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

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

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

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

residue values and then summed in a probabilistic assessment. The resulting distribution of 

exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who 

reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported 

eating the relevant commodities as well as those who did not) basis. In accordance with HED 

policy, per capita exposure and risk are reported for analyses performed at all levels of 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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refinement. However, for deterministic assessments, any significant differences in user vs. per 

capita exposure and risk are specifically identified and noted in the risk assessment.

VI. Toxicological Information

The doses and endpoints for dietary risk assessment were selected by the flazasulfuron risk 

assessment team. A summary of this information is presented in Table 2. 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. 

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. 

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. 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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VII. 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 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 50-99 years. Cancer risk is 

determined for the general U.S. population only.

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

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 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 3.1% aPAD for all infants (<1 year old), the most highly exposed 

subgroup. 

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

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 (9% of 

the cPAD) and all population subgroups listed in Table 3. The most highly exposed 

population subgroup was all infants (<1 year old) at 23% 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 0.004982 1.0 0.001187 9.1

All Infants (< 1 year old) 0.015502 3.1 0.003022 23

Children 1-2 years old 0.007755 1.6 0.001769 14

Children 3-5 years old 0.006309 1.3 0.001485 11

Children 6-12 years old 0.004777 <1.0 0.001054 8.1

Youth 13-19 years old 0.004142 <1.0 0.000867 6.7

Adults 20-49 years old 0.004891 <1.0 0.001177 9.1

Adults 50-99 years old 0.004370 <1.0 0.001165 9.0

Females 13-49 years old 0.004969 <1.0 0.001173 9.0

VIII. 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.
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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IX. 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.

X. List of Attachments

Attachment 1: Acute Food and Water Residue Input File.

Attachment 2: Acute Food and Water Results File.

Attachment 3: Acute Food Alone Residue Input File.

Attachment 4: Acute Food Alone Results File.

Attachment 5: Chronic Food and Water Residue Input File.

Attachment 6: Chronic Food and Water Results File.

Attachment 3: Chronic Food Alone Residue Input File.

Attachment 4: Chronic Food Alone Results File.
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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Attachment 1: Acute Food and Water Residue Input file

Filename: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\Flazasulfuron\2014 

tree nuts\acute FLAZ 012914.R08

Chemical: Flazasulfuron

RfD(Chronic): .013 mg/kg bw/day NOEL(Chronic): 1.3 mg/kg bw/day

RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 50 mg/kg bw/day

Date created/last modified: 01-23-2014/16:41:25 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

1001106000 10A Citron 0.010000 1.000 1.000 

1001107000 10A Citrus hybrids 0.010000 1.000 1.000 

1001108000 10A Citrus, oil 0.010000 1.000 1.000 

1001240000 10A Orange 0.010000 1.000 1.000 

1001241000 10A Orange, juice 0.010000 1.000 1.000 

1001241001 10A Orange, juice-babyfood 0.010000 1.000 1.000 

1001242000 10A Orange, peel 0.010000 1.000 1.000 

1001369000 10A Tangerine 0.010000 1.000 1.000 

1001370000 10A Tangerine, juice 0.010000 1.000 1.000 

1002197000 10B Kumquat 0.010000 1.000 1.000 

1002199000 10B Lemon 0.010000 1.000 1.000 

1002200000 10B Lemon, juice 0.010000 1.000 1.000 

1002200001 10B Lemon, juice-babyfood 0.010000 1.000 1.000 

1002201000 10B Lemon, peel 0.010000 1.000 1.000 

1002206000 10B Lime 0.010000 1.000 1.000 

1002207000 10B Lime, juice 0.010000 1.000 1.000 

1002207001 10B Lime, juice-babyfood 0.010000 1.000 1.000 

1003180000 10C Grapefruit 0.010000 1.000 1.000 

1003181000 10C Grapefruit, juice 0.010000 1.000 1.000 

1003307000 10C Pummelo 0.010000 1.000 1.000 

1304175000 13D Grape 0.010000 1.000 1.000 

1304176000 13D Grape, juice 0.010000 1.000 1.000 

1304176001 13D Grape, juice-babyfood 0.010000 1.000 1.000 

1304179000 13D Grape, wine and sherry 0.010000 1.000 1.000 

1400003000 14 Almond 0.010000 1.000 1.000 

1400003001 14 Almond-babyfood 0.010000 1.000 1.000 

1400004000 14 Almond, oil 0.010000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.010000 1.000 1.000 

1400059000 14 Brazil nut 0.010000 1.000 1.000 

1400068000 14 Butternut 0.010000 1.000 1.000 

1400081000 14 Cashew 0.010000 1.000 1.000 

1400092000 14 Chestnut 0.010000 1.000 1.000 

1400155000 14 Hazelnut 0.010000 1.000 1.000 

1400156000 14 Hazelnut, oil 0.010000 1.000 1.000 

1400185000 14 Hickory nut 0.010000 1.000 1.000 

1400213000 14 Macadamia nut 0.010000 1.000 1.000 

1400269000 14 Pecan 0.010000 1.000 1.000 

1400278000 14 Pine nut 0.010000 1.000 1.000 

1400282000 14 Pistachio 0.010000 1.000 1.000 

1400391000 14 Walnut 0.010000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.090800 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.090800 1.000 1.000 

9500177000 O Grape, leaves 0.010000 1.000 1.000 

9500178000 O Grape, raisin 0.010000 1.000 1.000 

9500362000 O Sugarcane, sugar 0.010000 1.000 1.000 

9500362001 O Sugarcane, sugar-babyfood 0.010000 1.000 1.000 

9500363000 O Sugarcane, molasses 0.010000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 0.010000 1.000 1.000 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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Attachment 2: Acute and Water Results File

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

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

Residue file: acute FLAZ 012914.R08 Adjustment factor #2 NOT used.

Analysis Date: 01-23-2014/16:44:14 Residue file dated: 01-23-2014/16:41:25

NOEL (Acute) = 50.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "tree nut use"

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

Summary calculations--per capita:

--- 95th Percentile---- --- 99th Percentile---- ---99.9th Percentile----

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

Total US Population:

 0.004982 1.00 10036 0.008188 1.64 6106 0.015585 3.12 3208 

All Infants:

 0.015502 3.10 3225 0.021023 4.20 2378 0.030811 6.16 1622 

Female 13-50:

 0.004951 0.99 10098 0.007295 1.46 6853 0.010270 2.05 4868 

Children 1-2:

 0.007755 1.55 6447 0.011976 2.40 4175 0.028669 5.73 1744 

Children 3-5:

 0.006309 1.26 7925 0.009556 1.91 5232 0.015760 3.15 3172 

Children 6-12:

 0.004777 0.96 10466 0.007724 1.54 6473 0.012016 2.40 4161 

Youth 13-19:

 0.004142 0.83 12072 0.006805 1.36 7347 0.010277 2.06 4865 

Adults 20-49:

 0.004891 0.98 10222 0.007266 1.45 6881 0.010585 2.12 4723 

Adults 50-99:

 0.004370 0.87 11442 0.006584 1.32 7593 0.010431 2.09 4793 

Female 13-49:

 0.004969 0.99 10062 0.007297 1.46 6851 0.010188 2.04 4907 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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Attachment 3: Acute Food Alone Residue Input file 

Filename: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\Flazasulfuron\2014 

tree nuts\acute food alone FLAZ 012914.R08

Chemical: Flazasulfuron

RfD(Chronic): .013 mg/kg bw/day NOEL(Chronic): 1.3 mg/kg bw/day

RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 50 mg/kg bw/day

Date created/last modified: 01-23-2014/16:41:25 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

9500177000 O Grape, leaves 0.010000 1.000 1.000 

9500178000 O Grape, raisin 0.010000 1.000 1.000 

9500363000 O Sugarcane, molasses 0.010000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 0.010000 1.000 1.000 

9500362000 O Sugarcane, sugar 0.010000 1.000 1.000 

9500362001 O Sugarcane, sugar-babyfood 0.010000 1.000 1.000 

1001106000 10A Citron 0.010000 1.000 1.000 

1001107000 10A Citrus hybrids 0.010000 1.000 1.000 

1001108000 10A Citrus, oil 0.010000 1.000 1.000 

1003180000 10C Grapefruit 0.010000 1.000 1.000 

1003181000 10C Grapefruit, juice 0.010000 1.000 1.000 

1002197000 10B Kumquat 0.010000 1.000 1.000 

1002199000 10B Lemon 0.010000 1.000 1.000 

1002200000 10B Lemon, juice 0.010000 1.000 1.000 

1002200001 10B Lemon, juice-babyfood 0.010000 1.000 1.000 

1002201000 10B Lemon, peel 0.010000 1.000 1.000 

1002206000 10B Lime 0.010000 1.000 1.000 

1002207000 10B Lime, juice 0.010000 1.000 1.000 

1002207001 10B Lime, juice-babyfood 0.010000 1.000 1.000 

1001240000 10A Orange 0.010000 1.000 1.000 

1001241000 10A Orange, juice 0.010000 1.000 1.000 

1001241001 10A Orange, juice-babyfood 0.010000 1.000 1.000 

1001242000 10A Orange, peel 0.010000 1.000 1.000 

1003307000 10C Pummelo 0.010000 1.000 1.000 

1001369000 10A Tangerine 0.010000 1.000 1.000 

1001370000 10A Tangerine, juice 0.010000 1.000 1.000 

1304175000 13D Grape 0.010000 1.000 1.000 

1304176000 13D Grape, juice 0.010000 1.000 1.000 

1304176001 13D Grape, juice-babyfood 0.010000 1.000 1.000 

1304179000 13D Grape, wine and sherry 0.010000 1.000 1.000 

1400003000 14 Almond 0.010000 1.000 1.000 

1400004000 14 Almond, oil 0.010000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.010000 1.000 1.000 

1400003001 14 Almond-babyfood 0.010000 1.000 1.000 

1400059000 14 Brazil nut 0.010000 1.000 1.000 

1400068000 14 Butternut 0.010000 1.000 1.000 

1400081000 14 Cashew 0.010000 1.000 1.000 

1400092000 14 Chestnut 0.010000 1.000 1.000 

1400155000 14 Hazelnut 0.010000 1.000 1.000 

1400156000 14 Hazelnut, oil 0.010000 1.000 1.000 

1400185000 14 Hickory nut 0.010000 1.000 1.000 

1400213000 14 Macadamia nut 0.010000 1.000 1.000 

1400269000 14 Pecan 0.010000 1.000 1.000 

1400278000 14 Pine nut 0.010000 1.000 1.000 

1400282000 14 Pistachio 0.010000 1.000 1.000 

1400391000 14 Walnut 0.010000 1.000 1.000 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

______________________________________________________________________________________

Page 12 of 16

Attachment 4: Acute and Water Results File

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

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

Residue file: acute food alone FLAZ 012914.R08 Adjustment factor #2 NOT used.

Analysis Date: 02-19-2014/14:14:40 Residue file dated: 02-19-2014/14:08:51

NOEL (Acute) = 50.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "food alone"

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

Summary calculations--per capita:

--- 95th Percentile---- --- 99th Percentile---- ---99.9th Percentile----

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

Total US Population:

 0.000092 0.02 544062 0.000202 0.04 247304 0.000499 0.10 100274 

All Infants:

 0.000118 0.02 423905 0.000304 0.06 164253 0.000578 0.12 86563 

Children 1-2:

 0.000340 0.07 147230 0.000598 0.12 83613 0.001048 0.21 47725 

Children 3-5:

 0.000247 0.05 202643 0.000451 0.09 110769 0.000676 0.14 73978 

Children 6-12:

 0.000124 0.02 402706 0.000229 0.05 218781 0.000576 0.12 86788 

Youth 13-19:

 0.000084 0.02 597046 0.000144 0.03 346111 0.000246 0.05 203184 

Adults 20-49:

 0.000069 0.01 727516 0.000121 0.02 414233 0.000252 0.05 198670 

Adults 50-99:

 0.000061 0.01 817053 0.000110 0.02 453504 0.000198 0.04 252152 

Female 13-49:

 0.000070 0.01 717050 0.000129 0.03 387730 0.000245 0.05 204191 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

______________________________________________________________________________________

Page 13 of 16

Attachment 5: Chronic Food and Water Residue Input file 

Filename: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\Flazasulfuron\2014 

tree nuts\chronic FLAZ 012914.R08

Chemical: Flazasulfuron

RfD(Chronic): .013 mg/kg bw/day NOEL(Chronic): 1.3 mg/kg bw/day

RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 50 mg/kg bw/day

Date created/last modified: 01-23-2014/16:40:39 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

1001106000 10A Citron 0.010000 1.000 1.000 

1001107000 10A Citrus hybrids 0.010000 1.000 1.000 

1001108000 10A Citrus, oil 0.010000 1.000 1.000 

1001240000 10A Orange 0.010000 1.000 1.000 

1001241000 10A Orange, juice 0.010000 1.000 1.000 

1001241001 10A Orange, juice-babyfood 0.010000 1.000 1.000 

1001242000 10A Orange, peel 0.010000 1.000 1.000 

1001369000 10A Tangerine 0.010000 1.000 1.000 

1001370000 10A Tangerine, juice 0.010000 1.000 1.000 

1002197000 10B Kumquat 0.010000 1.000 1.000 

1002199000 10B Lemon 0.010000 1.000 1.000 

1002200000 10B Lemon, juice 0.010000 1.000 1.000 

1002200001 10B Lemon, juice-babyfood 0.010000 1.000 1.000 

1002201000 10B Lemon, peel 0.010000 1.000 1.000 

1002206000 10B Lime 0.010000 1.000 1.000 

1002207000 10B Lime, juice 0.010000 1.000 1.000 

1002207001 10B Lime, juice-babyfood 0.010000 1.000 1.000 

1003180000 10C Grapefruit 0.010000 1.000 1.000 

1003181000 10C Grapefruit, juice 0.010000 1.000 1.000 

1003307000 10C Pummelo 0.010000 1.000 1.000 

1304175000 13D Grape 0.010000 1.000 1.000 

1304176000 13D Grape, juice 0.010000 1.000 1.000 

1304176001 13D Grape, juice-babyfood 0.010000 1.000 1.000 

1304179000 13D Grape, wine and sherry 0.010000 1.000 1.000 

1400003000 14 Almond 0.010000 1.000 1.000 

1400003001 14 Almond-babyfood 0.010000 1.000 1.000 

1400004000 14 Almond, oil 0.010000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.010000 1.000 1.000 

1400059000 14 Brazil nut 0.010000 1.000 1.000 

1400068000 14 Butternut 0.010000 1.000 1.000 

1400081000 14 Cashew 0.010000 1.000 1.000 

1400092000 14 Chestnut 0.010000 1.000 1.000 

1400155000 14 Hazelnut 0.010000 1.000 1.000 

1400156000 14 Hazelnut, oil 0.010000 1.000 1.000 

1400185000 14 Hickory nut 0.010000 1.000 1.000 

1400213000 14 Macadamia nut 0.010000 1.000 1.000 

1400269000 14 Pecan 0.010000 1.000 1.000 

1400278000 14 Pine nut 0.010000 1.000 1.000 

1400282000 14 Pistachio 0.010000 1.000 1.000 

1400391000 14 Walnut 0.010000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.055600 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.055600 1.000 1.000 

9500177000 O Grape, leaves 0.010000 1.000 1.000 

9500178000 O Grape, raisin 0.010000 1.000 1.000 

9500362000 O Sugarcane, sugar 0.010000 1.000 1.000 

9500362001 O Sugarcane, sugar-babyfood 0.010000 1.000 1.000 

9500363000 O Sugarcane, molasses 0.010000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 0.010000 1.000 1.000 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

______________________________________________________________________________________

Page 14 of 16

Attachment 6: Chronic Food and Water Results File

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

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

Residue file name: C:\Documents and Settings\cwalls\My 

Documents\Cassi\HED\Flazasulfuron\2014 tree nuts\chronic FLAZ 012914.R08

 Adjustment factor #2 NOT used.

Analysis Date 01-23-2014/16:42:09 Residue file dated: 01-23-2014/16:40:39

Reference dose (RfD, Chronic) = .013 mg/kg bw/day

COMMENT 1: tree nut use

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.001187 9.1%

Hispanic 0.001140 8.8%

Non-Hisp-White 0.001218 9.4%

Non-Hisp-Black 0.000987 7.6%

Non-Hisp-Other 0.001365 10.5%

Nursing Infants 0.001063 8.2%

Non-Nursing Infants 0.003897 30.0%

Female 13+ PREG 0.001121 8.6%

Children 1-6 0.001566 12.0%

Children 7-12 0.001001 7.7%

Male 13-19 0.000820 6.3%

Female 13-19/NP 0.000913 7.0%

Male 20+ 0.001100 8.5%

Female 20+/NP 0.001239 9.5%

Seniors 55+ 0.001142 8.8%

All Infants 0.003022 23.2%

Female 13-50 0.001175 9.0%

Children 1-2 0.001770 13.6%

Children 3-5 0.001485 11.4%

Children 6-12 0.001054 8.1%

Youth 13-19 0.000867 6.7%

Adults 20-49 0.001177 9.1%

Adults 50-99 0.001165 9.0%

Female 13-49 0.001173 9.0%

-------------------------------------------------------------------------------
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

______________________________________________________________________________________

Page 15 of 16

Attachment 7: Chronic Food Alone Residue Input file 

Filename: C:\Documents and Settings\cwalls\My Documents\Cassi\HED\Flazasulfuron\2014 

tree nuts\chronic food alone FLAZ 012914.R08

Chemical: Flazasulfuron

RfD(Chronic): .013 mg/kg bw/day NOEL(Chronic): 1.3 mg/kg bw/day

RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 50 mg/kg bw/day

Date created/last modified: 01-23-2014/16:40:39 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

9500177000 O Grape, leaves 0.010000 1.000 1.000 

9500178000 O Grape, raisin 0.010000 1.000 1.000 

9500363000 O Sugarcane, molasses 0.010000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 0.010000 1.000 1.000 

9500362000 O Sugarcane, sugar 0.010000 1.000 1.000 

9500362001 O Sugarcane, sugar-babyfood 0.010000 1.000 1.000 

1001106000 10A Citron 0.010000 1.000 1.000 

1001107000 10A Citrus hybrids 0.010000 1.000 1.000 

1001108000 10A Citrus, oil 0.010000 1.000 1.000 

1003180000 10C Grapefruit 0.010000 1.000 1.000 

1003181000 10C Grapefruit, juice 0.010000 1.000 1.000 

1002197000 10B Kumquat 0.010000 1.000 1.000 

1002199000 10B Lemon 0.010000 1.000 1.000 

1002200000 10B Lemon, juice 0.010000 1.000 1.000 

1002200001 10B Lemon, juice-babyfood 0.010000 1.000 1.000 

1002201000 10B Lemon, peel 0.010000 1.000 1.000 

1002206000 10B Lime 0.010000 1.000 1.000 

1002207000 10B Lime, juice 0.010000 1.000 1.000 

1002207001 10B Lime, juice-babyfood 0.010000 1.000 1.000 

1001240000 10A Orange 0.010000 1.000 1.000 

1001241000 10A Orange, juice 0.010000 1.000 1.000 

1001241001 10A Orange, juice-babyfood 0.010000 1.000 1.000 

1001242000 10A Orange, peel 0.010000 1.000 1.000 

1003307000 10C Pummelo 0.010000 1.000 1.000 

1001369000 10A Tangerine 0.010000 1.000 1.000 

1001370000 10A Tangerine, juice 0.010000 1.000 1.000 

1304175000 13D Grape 0.010000 1.000 1.000 

1304176000 13D Grape, juice 0.010000 1.000 1.000 

1304176001 13D Grape, juice-babyfood 0.010000 1.000 1.000 

1304179000 13D Grape, wine and sherry 0.010000 1.000 1.000 

1400003000 14 Almond 0.010000 1.000 1.000 

1400004000 14 Almond, oil 0.010000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.010000 1.000 1.000 

1400003001 14 Almond-babyfood 0.010000 1.000 1.000 

1400059000 14 Brazil nut 0.010000 1.000 1.000 

1400068000 14 Butternut 0.010000 1.000 1.000 

1400081000 14 Cashew 0.010000 1.000 1.000 

1400092000 14 Chestnut 0.010000 1.000 1.000 

1400155000 14 Hazelnut 0.010000 1.000 1.000 

1400156000 14 Hazelnut, oil 0.010000 1.000 1.000 

1400185000 14 Hickory nut 0.010000 1.000 1.000 

1400213000 14 Macadamia nut 0.010000 1.000 1.000 

1400269000 14 Pecan 0.010000 1.000 1.000 

1400278000 14 Pine nut 0.010000 1.000 1.000 

1400282000 14 Pistachio 0.010000 1.000 1.000 

1400391000 14 Walnut 0.010000 1.000 1.000 
Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

______________________________________________________________________________________

Page 16 of 16

Attachment 8: Chronic Food Alone Results File

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

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

Residue file name: C:\Documents and Settings\cwalls\My 

Documents\Cassi\HED\Flazasulfuron\2014 tree nuts\chronic food alone FLAZ 012914.R08

 Adjustment factor #2 NOT used.

Analysis Date 02-19-2014/14:11:20 Residue file dated: 02-19-2014/14:10:20

Reference dose (RfD, Chronic) = .013 mg/kg bw/day

COMMENT 1: food alone

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.000022 0.2%

Hispanic 0.000028 0.2%

Non-Hisp-White 0.000020 0.2%

Non-Hisp-Black 0.000026 0.2%

Non-Hisp-Other 0.000024 0.2%

Nursing Infants 0.000009 0.1%

Non-Nursing Infants 0.000025 0.2%

Female 13+ PREG 0.000024 0.2%

Children 1-6 0.000075 0.6%

Children 7-12 0.000030 0.2%

Male 13-19 0.000019 0.1%

Female 13-19/NP 0.000017 0.1%

Male 20+ 0.000016 0.1%

Female 20+/NP 0.000016 0.1%

Seniors 55+ 0.000017 0.1%

All Infants 0.000020 0.2%

Female 13-50 0.000016 0.1%

Children 1-2 0.000090 0.7%

Children 3-5 0.000070 0.5%

Children 6-12 0.000034 0.3%

Youth 13-19 0.000018 0.1%

Adults 20-49 0.000016 0.1%

Adults 50-99 0.000016 0.1%

Female 13-49 0.000016 0.1%

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