Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011



### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHING T ON, D.C. 20460



### MEMORANDUM

DA TE : February 5, 2014 OFFICE OF

CHEMICAL SAFETY AND
POLLUTION PREVENTION



### SUBJEC T: Flazasulfuron: Acu t e 

### & 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 Act i on: Section 3 Registration

Case No

. : N/ A Risk Assessment Type: Dietary

TXR No.: NA CAS No

. : 104040-78-0

40 CFR: § 180.655 MRIDNo.: NA



### REVIEWER :

THROUGH:

TO : Cassi Walls, Senior Biologist

# ~ -:t_

# L)~ Risk Assessment Branch 3 (RABBI)

Health Effects Division (HED; 7509P)

Dennis McNeilly

, Chemist

# ~ tw{- 

# WZ

# ~ Meheret Negussie, Chemist 

## /ieAerd

# ;::,_. Die tary Exposure Science Advisory Council (D E SAC)

# ~n~D (7509P)

# tit~t/ 

# / /

Christine Olinger

, Branch Ch i ef ; 

# J**~** RABIIIIHED (7509P)

. 

# f'

Kable Davis/Em il y Hartman, RM#25 Registra t i on Division (7505P)

Executive Summary

Acute & chronic aggregate dietary (food and drinking wate r) exposure and risk assessments

were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity In take Database (DEEM-FC ID ) Version 3. 1 6, which uses food consumpt ion data

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

What We Ea t in Ame r ica (NHANES/WWEIA). This die tary survey was conducted f r om 2003



## to 2008. The 

## ana l ysis was 

## performed to support a registration request for use of tlazas ulfuron

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

PC Code: 119011

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Page 2 of 16 

### 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 exp osure 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. Th e chronic dietary exposure estimates for food and drinking water are below HED’s level of concern for the gener al 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

Fl azasulfuron 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 equ ivalent 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 wh en 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 flazasulfu ron was conducted by C. Walls (09/12/12 , DP 405650 ).Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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Page 3 of 16 

### II. Residue Information

Flazasulfuron U se:

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 Kn owledgebase 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

f act 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 f or citrus, grapes and sugarcane ( listed below) were used to

conduct the dietary analyse s.

E stablished Tolerances “ General”:

Citrus

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

................................ ................................ .... 0. 0 1 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, p rocessing factors for parent flazasulfuron could not be calculated for any of the processed commodities be cause no quantifi able residues of parent were measured . Th erefore, 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

pro cessing 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 analys e s.

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 Tr ee 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

- E XAMs )

. For groundwater, EDWC s 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, D TPP, 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 ground water EDWCs are shown in T able 1

.Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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Page 5 of 16 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 individual s 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 reci pe 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 retain ed 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 subgroup s: 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 f ood 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/fo od 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 ofFlazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

PC Code: 119011

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Page 6 of 16 

### 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.

V I

. Toxicological Information

The doses and endpoints for dietary risk assessment were selected by the fla zasulfuron 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 s how 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 susce ptibility concerns based on the developmental and rep roductive

studies.

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

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

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 t he

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 ob served adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (intraspecies). UF H = 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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### V I I. Results/Discussion

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

exceeds 100% of the PAD. The DEEM

- FCID analyses estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table s 3 and 4 are for the gene ral 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 an d Drinking Water) Exposure Analysis

The results of the acute dietary (food + drinking 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 are all below HED’s level of concern (<100% aPAD) at the 95 th 

### percentile of exposure for the general U.S. population and all populat ion 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 w as 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 ( 95 th Percentile ) Chronic Dietary

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

General U.S. Population 0.00498 2 1 .0 0.001187 9 .1
All Infants (< 1 year old) 0.015502 3 .1 0.003022 23

Children 1

- 2 years old 0.00775 5 1.6 0.001769 14

Children 3

- 5 years old 0.00630 9 1 .3 0.001485 11

Children 6

- 12 years old 0.004777 < 1 .0 0.001054 8 .1

Youth 13

- 19 years old 0.00414 2 <1.0 0.000867 6.7

Adults 20

- 49 years old 0.0048 91 <1.0 0.001177 9 .1

Adults 50

- 99 years old 0.0043 70 <1.0 0.001165 9 .0

Females 13

- 49 years old 0.00496 9 < 1 .0 0.001173 9 .0



### VII I . 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 , 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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### I X

. 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 infan ts 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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Page 9 of 16 

### 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

D ate 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 hybri ds 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, ju ice 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 1.00 0

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 Chest nut 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 Sugarca ne, molasses

- babyfood 0.010000 1.000 1.000Flazasulfuron Dietary Exposure and Risk Assessment DP Number: 417419

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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 4907Flazasulfuron 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 n uts \ 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 Sugar cane, 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 L emon 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 1.0 00 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 1.000Flazasulfuron 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

RA C/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 0.00049 9 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 20264 3 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 204191Flazasulfuron 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 0.01000 0 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 1.00 0
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 Butte rnut 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 W alnut 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 1.000Flazasulfuron 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 0 12914.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 0.0 01054 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 0.0100 00 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

10011 08000 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 0.01 0000 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

100 2207001 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 1.0 00

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 Maca damia 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 1.000Flazasulfuron 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%

Ma le 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%

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