### UNITED STATES ENVIRONMENTAL P RO TEC TI ON AGENCY 

### WASHINGTON, D.C. 20460

MEMORANDUM

Date: 12-NOV-2014 OFFICE OF CHEMICAL SA FETY AND POLLUTION PREVENTION



### SUBJECT: Sedaxane. Acute, Chronic, and Cancer Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to Support Seed Treatment Uses on Cotton and Sugar Beet.

PC Code: 129223 Decision No.: 489552 Petition No.: 4F8263 

### DP Barcode: 04 23821 Registration No.: 100-13 

### 81 Regulatory Action: Sect i on 3 Re gistrat ion 

### CaseNo.: NA Risk Assessment Type: Dietary Aggregate Risk 

### TXRNo.: NA CAS No.: 874967-67-6 40 

### CFR: §180.665 

### MRIDNo.: NA



### FROM:

THROUGH: William H

. Donovan, Ph.D., Chemist

# LJ~ 

# /j

,**~** Risk Assessment Branch V H ealth Effects Division (7509P)

# MohsenSahafeyen,Chem~·st .

# V~~ Seyed Tadayon, Chemis Dietary Exposure Science A isory Council (DESAC) HED (7509P)



### TO: Heath er Garvie, Risk Manager Reviewer Fungicide Branch Re gistratio n Division (7505P)

Page 1 of 18Sedaxane (129223) Dietary Exposure and Risk Assessment 0423821



### Executive Summary

Acute, chronic, and cancer aggregate dietary (food and drinking water) exposure and risk
assessments were conducted using the Dietary Exposure Eva l uation Model wi t h the Food Commodity Intake Database (DEEM-FCID) Vers ion 3.16. Th is software incorporates 2003- 2008 food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We E at in America

, (NHANES/WWEIA). The analyses

were performed to support a Section 3 registration request for seed treatment uses of sedaxane on cotton and sugar beet. This memo was reviewed by two members of the DESAC, per the current DESAC SOP.

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization A highly conservative acute dietary assessment was conducted using tolerance-level residues, 100% crop treated assumptions, and screening-level estimated drinking water concentrations (EDWCs). At the 95 1 h 

### percentile of exposure , the estimated risk is< 2% of the acute population adjusted dose (aPAD) for the U.S. population and all population subgroups.

Chronic and Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization Partially refined chronic and cancer dietary assessments were conducted using anticipated residue levels, percent crop treated data, and screening-level EDWCs. The estimated risk is 

### :S 1% of the chronic population adjusted dose ( cP AD) for the U.S. population and all population subgroups. Sedaxane has been classified as "Likely to be Carcinogenic to Humans" (TXR No

. 0055854, J. Kidwell, 18-MA Y-11). A linear low

- dose ex tr apolation model 

### (Q,*) was used to estima t e cancer risk, with a Q, 

# *

= 

### 4.64 x 1 

# o- 3 

### (mg/kg/dayy 1 • 

### The cancer risk estimate to the U.S.
popu l ation is 2.0 X 

### 1 

# o

6

.



### 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 the point of departure (PoD) (e

. g., no observed adverse effect l evel ; NOAEL, low est observed adverse effect level; LOAEL) divided by the required uncertainty or safety factors.

For acute and chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in more detail are

ava ilable on the EPA/pesticides web site: "Avai l able Information on Assessing E xposure from Pesticides, A User's Guide," 21-JUN-2000, web link: h tt p: // www

. e p a

. gov / fedrgst r! EPA

P EST / 2000 / July / Day

- 12 / 6061. p df; or see SOP 99.6 (20-AUG-1999).

T he most recent dietary risk assessment for sedaxane was conducted by W. Donovan (D412218, 12-JUN

- 2013).

Page 2 of 18Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 3 of 18 II. Residue Information

T olerance s for sedaxane are established under 40 CFR § 180. 665. The residue of concern in plants consists of the cis

- and trans

- isomers of the parent compound. Residue levels in most food commodities were less than the limit of quantitation (LOQ) of 0.005 ppm for both isomers. Summing these residues resulted in the recommended tolerance level of 0.01 ppm, and this value was used in the acute dietary exposure ana lysis for all food RACs except potato, where the residue was 0.02 ppm.

For the chronic dietary analysis, it was determined that anticipate d residues should be used

, as a screening approach resulted in cancer risk estimates that exceeded 1 x 10

- 6



### . Typic ally, anticipated residues for chronic dietary exposure estimates are determined as the average residues from field trials or monitoring data. For sedaxane, the anticipated residues were conservatively determined as 1⁄2 × tolerance, which was 1⁄2 × LOQ or 0.005 ppm for all food RACs except potato, where the anticipated residue was 0.0 1 ppm

. In livestock, the residue of concern for risk assessment is parent plus metabolite CSCD658906 (D406945
, E. Holman

, 19

- DEC

- 2012 )

. However, all current and propose d uses of sedaxane have been classified as 180.6 (a) (3), no reasonable expectation of finite residues in livestock commodities ( D407472
, W. Donovan
, 12

- MAR

- 2013 ). For the current petition, t he recommended sedaxane tolerances are shown in Table 1.

Table 1. Tolerance Summary for Sedaxane. Commodity Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition Beet, sugar 0.0 1 0.0 1 Cotton, undelinted seed 0.0 1 0.0 1



### The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010; however, the samples were not analyzed for sedaxane . As a result, residues in fish were not included in the assessment.

III. Percent Crop Treated Information D389267, C. Doucoure and T. Chandgoyal, 22

- JUN

- 2011 D409503, T. Chandgoyal and C. Doucoure, 29

- APR

- 2013



### The acute dietary exposure assessments assumed 100% crop treated for all registered and proposed crops.

For chronic and cancer dietary exposure assessment, 100% crop treated was assumed for all commodities except for soybeans (51%) and wheat (32%)

, which incorporated average percent crop treated estimates. Average percent crop treated estimates were also used for the proposed use on potato (67%).Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 4 of 18 IV. Drinking Water Data

EDWCs used in the dietary risk assessment were provided by the Environmental Fat e and Effects Division (EFED) : “Drinking Water Assessment for the Proposed New Use of Sedaxane as a Seed Treatment on Corn, Sorghum, Dried Shelled Pea and Bean (Subgroup 6C; except soybean), Ra peseed (Subgroup 20A), and Potato ” (D405391 & D407956

, R. Bohaty & J. Hetrick

, 18

- MAR

- 20 13 )

. EFED confirmed th at EDWCs based on the potato use pattern are protective of those based on cotton or sugar beet use patterns (D419976, R. Bohaty, 23

- OCT

2014). W ater residues were incorporated in the DEEM

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

The sedaxane residues of concern in drinking water include b oth isomers of parent sedaxane plus CSCD668094 and CS CD668095 ( D406945, E. Holman, 19

- DEC

- 2012 )

.

T here are no monitoring data currently available for sedaxane or its residues of concern in drinking water

. EDWCs were generated using computer modeling procedures . T he screening model FIRST (FQPA I ndex Reservoir Screening Tool ) was used to calculate the surface water EDWCs. G round water estimates were provided from the ground water model PRZM

- GW using the GW

- GUI (Graphical User Interface, version 1.0, Dec ember 11, 2012)

. For dietary risk
assessment pur

poses , the ground water EDWC s w ere selected as they were higher than the corresponding surface water EDWCs

. Additional information concerning the water models is available at the EPA internet site: http://www.epa.gov/pesticides/science/models_pg.htm#aquat ic

. Maximum application rates for sedaxane as a high

- end estimate of exposure in drinking water were modeled based on the proposed labels

. C hemical specific and model input values were chosen in accordance with current EFED input pa rameter guidance (USEP A, 2009). No data are available on the amount of sedaxane that may come off a treated seed once it is planted; therefore, in all model runs

, 100% of sedaxane applied to the treated seed is assumed to be available for runoff and leaching in the form of sed axane or total toxic sedaxane residues. The maximum surface and ground w ater EDWCs for use in the human

- health risk assessment for sedaxane are shown in Table 2

.

T able 2. Maximum Estimate d Surface Water and Ground W ater Concentrations for Sedaxane and Major Degradates 1

. Scenario Surface Water Conc., ppb 2 Ground W ater Conc., ppb 3

Acute 4.1 22.0
Chronic & Cancer 1.2 19.3

1 EDWCs include residues of concern identified by the ROCKS

. Highest value for use in risk assessment is shown in bold.

2 From the FIRST model

. 3 From the PRZM

- GW model assuming sedaxane potato treatment every year

.Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 5 of 18 V. DEEM

- FCID Program and Consumption Information

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

- FCID, Version 3.16. This software incorporates 2003

- 2008 food consumption data from USDA’s NHAN ES/WWEIA. 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 po pulation 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 co ncluded 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

- 4 9, females 13

- 49, and adults 50

- 99 years o ld.

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. Ex posure 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

a nd 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 refinement. However, for deterministic assessments, any significant dif ferences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

VI. Toxicological Information

The s edaxane risk assessment team in consultation with the ToxSAC (Toxicology Science Advisory Co uncil ) selec ted doses and endpoints for risk assessment. The toxicological doses and endpoints used for dietary risk as sessment are summarized in T able 3 ( D 386415, W. Donovan et al.

, 16

- FEB

- 2012 )

.Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 6 of 18 Table 3

. Summary of Toxicological Doses and Endpoints for Sedaxane for Use in Dietary Human Health Risk Assessments

.
Exposure/ Scenario Point of

Departure Uncertainty/

FQPA Safety Factors RfD, PAD, Level of

Concern for Risk A ssessment Study and Toxicological Effects

Acute Dietary (All populations, including children and women 13

- 49 years of age) NOAEL=

3 0 mg/kg/day UF A = 10 x

UF H =10 x FQPA SF = 1x Acute RfD = 0.3 0

mg/kg/day

aPAD =0.3 mg/kg/day Acute neurotoxicity study in rats

NOAEL=30 mg/kg LOAEL=250 mg/kg based on reduced activity, decreased rearing, initial inactivity, piloerection, ruffled fur and recumben cy, decreased BW, decreased BWG and food consumption (males). In females, weakened condition, swaying gait, decreased activity, reduced muscle
tone an d decreased locomotor activity and rearing

.

Chronic Dietary (All Populations) NOAEL=

11 mg/kg/day UF A = 10 x

UF H =10 x FQPA SF = 1x Chronic RfD = 0.11

mg/kg/day

cPAD = 0.11 mg/kg/day Chronic toxicity study in rat s NOAEL= 11/14 mg/kg bw/day ♂/♀ LOAEL = 67/86 mg/kg bw/day ♂/♀, in males based on decreased hind limb grip strength

, increased liver weight, increased incidences of hepatocyte hypertrophy and eosinophilic foci, thyroid follicular cell hypertrophy, basophilic colloid, epithelial desquamation and increased phosphate levels (♂). In females, it was based on decreased body weight and body weight gain, increased liver weight and the same thyroid histopathology noted above for males.

Cancer Classification: “Likely to be Carcinogenic to Humans” based on significant tumor increases in two

adequate rodent carcinogenicity studies. Q 1 *= 4.64x10

- 3 (mg/kg/day)

- 1 Point of Departure (POD) = A data point or an estimated point that is derived from ob served dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adver se effect level. LOAEL = lowest observed adverse effect level. UF = unc ertainty 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 = chroni c). RfD = reference dose.


### The Agency recommends that the 10X FQPA safety factor for the protection of infants and children, be reduce d to 1X. T he risk assessments conducted for sedaxane were based on the most sensitive endpoints in the toxicity databa se, and the NOAELs selected for risk assessment are considered protective of potential developmental , neurotoxic, and immunotoxic effects for infants and children. Highly conservative exposure estimates were incorporated into the risk assessment for sedax ane

. T here are no residual uncertainties with regard to pre

- and/or post

natal toxicity

, neurotoxicity , or exposure; therefore, reduction of the 10X FQPA safety factor to 1X is appropriate.Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 7 of 18 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 Table 4 are for the general U.S. Popula tion, all infants (<1 year old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, females 13

- 49, adults 20

- 49, and adul ts 50

- 99 years. Cancer risk is determined for the general U.S. population only.

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization A highly conservative acute dietary assessment was conducted using tolerance

- level residues, 100% crop treated assumptions, and screening

- level EDWCs. At the 95 th 

### percentile of exposure, the estimated risk is < 1% of the acut e population adjusted dose (aPAD) for the U.S. population and all population subgroups. Results are shown in Table 4.

Chronic and Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization Partially refined chronic and cancer dietary assessments were conducted using anticipated residue levels, percent crop treated data, and screening

- level EDWCs. The estimated risk is < 2 % of the chronic population adjusted dose (cPAD) for the U.S. population and all population subgroups. The estimat ed exposure of the general U.S. population to sedaxane is 0.000 427 mg/kg/day. Multiplying the Q 1 

### * of 4.64 x 10

- 3 

### (mg/kg/day )

- 1 

### by the exposure value results in a cancer risk estimate of 2.0 x 10

- 6



### . Results are shown in Table 4.

Table 4 . Summary of Dietary (Food and Drinking Water) Exposure and Risk for Sedaxane. 1

Population Subgroup Acute Dietary ( 95th Percentile) Chronic Dietary Cancer

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

General U.S. Population 0.001286 < 1 0.000 427 < 1 0.000 427 2.0 × 10 - 6

All Infants (< 1 year old) 0.003876 1 .3 0.001076 1 .0

N/A N/A Children 1

- 2 years old 0.002074 < 1 0.000 636 < 1

Children 3

- 5 years old 0.001699 < 1 0.000 543 < 1

Children 6

- 12 years old 0.001290 < 1 0.000 391 < 1

Youth 13

- 19 years old 0.001069 < 1 0.000318 < 1

Adults 20

- 49 years old 0.001238 < 1 0.000 423 < 1

Adults 50

- 99 years old 0.001100 < 1 0.000 413 < 1

Females 13

- 49 years old 0.001259 < 1 0.000 420 < 1

1 Highest exposure identified in bold.Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 8 of 18 To assess the contribution of just food to the dietary exposure of sedaxane , acute , chronic

, and cancer analyse s were run without modeled water estimates. The results are reported in Table 5

, including 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 year population subgroups.

Results of Acute Dietary (Food Only ) Exposure Analysis A conservative acut e dietary assessment was conducted using tolerance

- level residues and 100% crop treated assumptions. At the 95 th 

### percentile of exposure, the estimated risk from food

sources is < 1% of the aPAD for the U.S. population and all population subgroup s. Result s are shown in Table 5

. Chronic and Cancer Dietary (Food Only) Exposure Results and Characterization Partially refined chronic and cancer dietary assessments were conducted using anticipated residue levels, and percent crop treated data. The estimated risk is < 1% of the cPAD for the U.S. population and all population subgroups. The estimated exposure of the general U.S. population to sedaxane is 0.000023 mg/kg/day. Multiplying the Q 1 

### * of 4.64 x 10

- 3 

### (mg/kg/day )

- 1 

### by the exposure value results in a fo od only cancer risk estimate of 1.1 x 10

- 7



### . Results are shown in Table 5.

Table 5 . Summary of Dietary (Food Only ) Exposure and Risk for Sedaxane. 1

Population Subgroup Acute Dietary ( 95th Percentile) Chronic Dietary Cancer

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

General U.S. Population 0.000165 < 1 0.000023 < 1 0.000 023 1.1 × 10 - 7

All Infants (< 1 year old) 0.000274 < 1 0.000034 < 1

N/A N/A Children 1

- 2 years old 0.000344 < 1 0.000 053 < 1

Children 3

- 5 years old 0.000302 < 1 0.000 052 < 1

Children 6

- 12 years old 0.000218 < 1 0.000 037 < 1

Youth 13

- 19 years old 0.000148 < 1 0.000024 < 1

Adults 20

- 49 years old 0.000122 < 1 0.000 019 < 1

Adults 50

- 99 years old 0.000098 < 1 0.000 015 < 1

Females 13

- 49 years old 0.000117 < 1 0.000 018 < 1

1 Highest exposure identified in bold.



### VIII. Characterization of Inputs/OutputsSedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 9 of 18 HED has conducted highly conservative acute dietary risk assessments. These assessments could be refined using anticipated residue levels instead of tolerance level residues and/or percent crop treated data. However, since acute risks were not of concern, no refinements were conducted. A food

- only exposure analysis demonstrated that food accounts for 13% of the total acute dietary exposure to sedaxane for the general U.S. population ([0.000165 mg/kg/day ÷ 0.001286 mg/kg/day] * 100).

For the chronic an d cancer dietary risk estimates, partially refined dietary risk assessments were conducted. The refinements consisted of anticipated residue levels and average percent crop treated information. These refinements were included because unrefined cancer ris k estimates exceeded 1 × 10

- 6



### . A food

- only exposure analysis demonstrate d tha t food accounts for 5 % of the total chronic dietary exposure to sedaxane for the general U.S. population ([0.000023 mg/kg/day ÷ 0.000427 mg/kg/day] * 100)

.

IX. Conclusions

H ED conducted acute dietary risk assessments which incorporated tolerance level residues, 100% crop treated assumptions

, default processing factors, and conservative, screening

- level drinking water concentrations

. Chronic and cancer dietary risk assessment s made use of anticipated residues, percent crop treated information [for wheat, soybean, and potato], default processing facto rs, and screening

- level drinking water concentrations

. Acute and chronic dietary risks to all population subgroups were <2 % of the aPAD and cPAD. Additionally, cancer risk to the US population was estimated at 2.0 x 10

- 6



### . HED is confident that the se assessment s do not underestimate risk to the general U.S. population or any population subgroup.

X. List of Attachments

Attachm ent 1. Acute Residue Input File Attachment 2. Acute Results File Attachment 3. Ch ronic Residue Input File Attachment 4 . Chronic Results File Attachment 5. Cancer Results File Attachment 6. Acute Results File (Food

- only) Attachment 7. Chronic Results File (Food

- only)Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 10 of 18 A ttachment 1. Acute Residue Input File

Filename: C: \ Users \ wdonovan \ Documents \ DEEM Version 3.16 \ 129223A3.R08 Chemical: Sedaxane RfD(Chronic): .11 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .3 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Q*= .0046 Date created/last modified: 11

- 05

- 2014/13:12:35 Program ver. 3.16, 03

- 08

- d Comment: sedaxane acute uses with 22 ppb water (PRZM

- GW)

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101052000 1A Beet, sugar 0.010000 1.000 1.000 0101053000 1A Beet, sugar, molasses 0.010000 1.000 1.000 0101053001 1A Beet, sugar, molasses

- babyfood 0.010000 1.000 1.000 0101052001 1A Beet, sugar

- babyfood 0.010000 1.000 1.000 0103296000 1C Potato, chips 0.020000 1.000 1.000 0103297000 1C Potato, dry (granules/ flakes) 0.020000 6.500 1.000 0103297001 1C Potato, dry (granules/ flakes)

- b 0.020000 6 .500 1.000 0103298000 1C Potato, flour 0.020000 1.000 1.000 0103298001 1C Potato, flour

- babyfood 0.020000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel

- babyfood 0.020000 1.000 1.000 0103299000 1C Potato, tuber, w/peel 0.020000 1.000 1.000 0103299001 1C Potato, tuber, w/peel

- babyfood 0.020000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.010000 1.000 1.000 0603030000 6C Bean, black, seed 0.010000 1.000 1.000 0603032000 6C Bean, broad, seed 0.010000 1.000 1.000 0603034000 6C Bean, cow pea, seed 0.010000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.010000 1.000 1.000 0603038000 6C Bean, lima, seed 0.010000 1.000 1.000 0603039000 6C Bean, mung, seed 0.010000 1.000 1.000 0603040000 6C Bean, navy, seed 0.010000 1.000 1.000 0603041000 6C Bean, pink, seed 0.010000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.010000 1.000 1.000 0603099000 6C Chickpea, flour 0.010000 1.000 1.000 0603098000 6C Chickpea, seed 0.010000 1.000 1.000 0603098001 6C Chickpea, seed

- babyfood 0.010000 1.000 1.000 0603182000 6C Guar, s eed 0.010000 1.000 1.000 0603182001 6C Guar, seed

- babyfood 0.010000 1.000 1.000 0603203000 6C Lentil, seed 0.010000 1.000 1.000 0603256000 6C Pea, dry 0.010000 1.000 1.000 0603256001 6C Pea, dry

- babyfood 0.010000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0.010000 1.000 1.000 0603348000 6C Soybean, flour 0.010000 1.000 1.00 0 0603348001 6C Soybean, flour

- babyfood 0.010000 1.000 1.000 0600350000 6 Soybean, oil 0.010000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.010000 1.000 1.000 0600347000 6 Soybe an, seed 0.010000 1.000 1.000 0600349000 6 Soybean, soy milk 0.010000 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.010000 1.000 1.000 1500027000 15 Barley, bran 0.010000 1.000 1.000 1500026000 15 Barley, flour 0.010000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 0.010000 1.000 1.000 1500025000 15 Barley, pearled barley 0.010000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 0.010000 1.000 1.000 1500065000 15 Buckwheat 0.010000 1.000 1.000 1500066000 15 Buckwheat , flour 0.010000 1.000 1.000 1500122000 15 Corn, field, bran 0.010000 1.000 1.000 1500120000 15 Corn, field, flour 0.010000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.010000 1.000 1.000 1500121000 15 Corn, field, meal 0.010000 1.000 1.000 1500121001 15 Corn, field, meal

- babyfood 0.010000 1.000 1.000 1500125000 15 Corn, field, oil 0.010000 1.000 1.000 1500125001 15 Corn, field, oil

- babyfood 0.010000 1.000 1.000 1500123000 15 Corn, field, starch 0.010000 1.000 1.000 1500123001 15 Corn, field, starch

- babyfood 0.010000 1.000 1.000 1500124000 15 Corn, f ield, syrup 0.010000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.010000 1.500 1.000 1500126000 15 Corn, pop 0.010000 1.000 1.000Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 11 of 18 1500127000 15 Corn, sweet 0.010000 1.000 1.000 1500127001 15 Corn, sweet

- babyfood 0.010000 1.000 1.000 1500226000 15 Millet, grain 0.010000 1.000 1.000 1500231000 15 Oat, bran 0.010000 1.000 1.00 0 1500232000 15 Oat, flour 0.010000 1.000 1.000 1500232001 15 Oat, flour

- babyfood 0.010000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 0.010000 1.000 1.000 1500233001 15 Oat, groats/rolled oats

- babyfood 0.010000 1.000 1.000 1500329000 15 Rye, flour 0.010000 1.000 1.000 1500328000 15 Rye, grain 0.010000 1.000 1.000 1500344000 15 Sorghum, grain 0.010000 1.000 1.000 1500345000 15 Sorghum, syrup 0.010000 1.000 1.000 1500381000 15 Triticale, flour 0.010000 1.000 1.000 1500381001 15 Triticale, flour

- babyfood 0.010000 1.000 1.000 1500404000 15 Wheat, bran 0.010000 1.000 1.000 1500402000 15 Wheat, flour 0.010000 1.000 1.000 1500402001 15 Wheat, fl our
- babyfood 0.010000 1.000 1.000 1500403000 15 Wheat, germ 0.010000 1.000 1.000 1500401000 15 Wheat, grain 0.010000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.010000 1.000 1.000 2003128000 20C Cottonseed, oil 0.010000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 0.010000 1.000 1.000 2001163000 20A Flax seed, oil 0.010000 1.000 1.000 2001319000 20A Rapeseed, oil 0.010000 1.000 1.000 2001319001 20A Rapeseed, oil

- babyfood 0.010000 1.000 1.000 2001337000 20A Sesame, oil 0.010000 1.000 1.000 8601000000 86A Water, direct, all sources 0.022000 1.000 1.000 R. Bohaty 18MAR13 8602000000 86B Water, indirect, all sources 0.022000 1.000 1.000 R. Bohaty 18MAR13Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 12 of 18 Attachment 2. Acute Results File

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for SEDAXANE NHANES 2003

- 2008 2

- Day Residue file: 129223A3.R08 Adjustment factor #2 NOT used. Analysis Date: 11

- 05

- 2014/14:09:56 Residue file dated: 11

- 05

- 2014/13:12:35 RAC/FF intake summed over 24 hours Run Comment: "sedaxane acute uses with 22 ppb water (PRZM

- GW) "

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

Summary calculations

-- per capita:

95 th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population: 0.001286 0.43 0.002100 0.70 0.003876 1.29 All Infants: 0.003876 1.29 0.005154 1.72 0.007493 2.50 Children 1

- 2: 0.002074 0.69 0.003127 1.04 0.007012 2.34 Chil dren 3

- 5: 0.001699 0.57 0.002442 0.81 0.003860 1.29 Children 6

- 12: 0.001290 0.43 0.001996 0.67 0.003187 1.06 Youth 13

- 19: 0.001069 0.36 0.001731 0. 58 0.002625 0.88 Adults 20

- 49: 0.001238 0.41 0.001791 0.60 0.002591 0.86 Adults 50

- 99: 0.001100 0.37 0.001649 0.55 0.002594 0.86 Female 13

- 49: 0.00125 9 0.42 0.001793 0.60 0.002523 0.84Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 13 of 18 Attachment 3. Chronic Residue Input File

Filename: C: \ Users \ wdonovan \ Documents \ DEEM Version 3.16 \ 129223C3.R08 Chemical: Sedaxane RfD(Chronic): .11 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .3 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Q*= .0046 Date created/last modified: 11

- 05

- 2014/13:13:55 Program ver. 3.16, 03

- 08

- d Comment: Sedaxane chronic uses with 19 ppb water (PRZM

- GW)

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101052000 1A Beet, sugar 0.005000 1.000 1.000 0101053000 1A Beet, sugar, molasses 0.005000 1.000 1.000 0101053001 1A Beet, sugar, molasses

- babyfood 0.005000 1.000 1.000 01 01052001 1A Beet, sugar

- babyfood 0.005000 1.000 1.000 0103296000 1C Potato, chips 0.010000 1.000 0.670 BEAD, 29APR13 0103297000 1C Potato, dry (granules/ flakes) 0.010000 6.500 0.670 BEAD, 29APR13 0 103297001 1C Potato, dry (granules/ flakes)

- b 0.010000 6.500 0.670 BEAD, 29APR13 0103298000 1C Potato, flour 0.010000 1.000 0.670 BEAD, 29APR13 0103298001 1C Potato, flour

- babyfood 0.010000 1.000 0.670 BEAD, 29APR13 0103300000 1C Potato, tuber, w/o peel 0.010000 1.000 0.670 BEAD, 29APR13 0103300001 1C Potato, tuber, w/o peel

- babyfood 0.010000 1.000 0.670 BEAD, 29APR13 0103299000 1C Potato, tuber, w/peel 0.010000 1.000 0.670 BEAD, 29APR13 0103299001 1C Potato, tuber, w/peel

- babyfood 0.010000 1.000 0.670 BEAD, 29APR13 0603035000 6C Bean, great northern, seed 0.005000 1.000 1.000 0603030000 6C Bean, black, seed 0.005000 1.000 1.000 0603032000 6C Bean, broad, seed 0.005000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.005000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.005000 1.000 1.000 0603038 000 6C Bean, lima, seed 0.005000 1.000 1.000 0603039000 6C Bean, mung, seed 0.005000 1.000 1.000 0603040000 6C Bean, navy, seed 0.005000 1.000 1.000 0603041000 6C Bean, pink, seed 0.005000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.005000 1.000 1.000 0603099000 6C Chickpea, flour 0.005000 1.000 1.000 0603098000 6C Chickpea, seed 0.0050 00 1.000 1.000 0603098001 6C Chickpea, seed

- babyfood 0.005000 1.000 1.000 0603182000 6C Guar, seed 0.005000 1.000 1.000 0603182001 6C Guar, seed

- babyfood 0.005000 1.000 1.000 06032 03000 6C Lentil, seed 0.005000 1.000 1.000 0603256000 6C Pea, dry 0.005000 1.000 1.000 0603256001 6C Pea, dry

- babyfood 0.005000 1.000 1.000 0603258000 6C Pea, pigeon, s eed 0.005000 1.000 1.000 0603348000 6C Soybean, flour 0.005000 1.000 0.510 BEAD, 22JUL11 0603348001 6C Soybean, flour

- babyfood 0.005000 1.000 0.510 BEAD, 22JUL11 0600350000 6 Soybean, oil 0.005000 1.000 0.510 BEAD, 22JUL11 0600350001 6 Soybean, oil

- babyfood 0.005000 1.000 0.510 BEAD, 22JUL11 0600347000 6 Soybean, seed 0.005000 1.000 0.510 BEAD, 22JUL11 0600349000 6 Soybean, soy milk 0.005000 1.000 0.510 BEAD, 22JUL11 0600349001 6 Soybean, soy milk

- babyfood or in 0.005000 1.000 0.510 BEAD, 22JUL11 1500027000 15 Barley, bran 0.005000 1.000 1.000 1500026000 15 Barley, flour 0.005000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 0.005000 1.000 1.000 1500025000 15 Barley, pearled barley 0.005000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 0.005000 1.000 1.000 1500065000 15 Buckwheat 0.005000 1.000 1.000 1500066000 15 Buckwheat, flour 0.005000 1.000 1.000 1500122000 15 Corn, field, bran 0.005000 1.000 1.000 1500120000 15 Corn, field, flour 0.005000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.005000 1.000 1.000 1500121000 15 Corn, field, meal 0.005000 1.000 1.000 1500121001 15 Corn, field, meal

- babyfood 0.005000 1.000 1.000 1500125000 15 Corn, field, oil 0.005000 1.000 1.000 1500125001 15 Corn, field, oil

- babyfood 0.005000 1.000 1.000 1500123000 15 Corn, field, starch 0.005000 1.000 1.000 1500123001 15 Corn, field, starch

- babyfood 0.005000 1.000 1.000 1500124000 15 Corn, field, syrup 0.005000 1.500 1.000Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 14 of 18 1500124001 15 Corn, field, syrup

- babyfood 0.005000 1.500 1.000 1500126000 15 Corn, pop 0.005000 1.000 1.000 1500127000 15 Corn, sweet 0.005000 1.000 1.000 1500127001 15 Corn, sweet

- babyfood 0.005000 1.000 1.0 00 1500226000 15 Millet, grain 0.005000 1.000 1.000 1500231000 15 Oat, bran 0.005000 1.000 1.000 1500232000 15 Oat, flour 0.005000 1.000 1.000 1500232001 15 Oat, flour

- babyfood 0.005000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 0.005000 1.000 1.000 1500233001 15 Oat, groats/rolled oats

- babyfood 0.005000 1.000 1.000 1500329000 15 Rye, flour 0.005000 1.000 1.000 1500328000 15 Rye, grain 0.005000 1.000 1.000 1500344000 15 Sorghum, grain 0.005000 1.000 1.000 1500345000 15 Sorghum, syrup 0.005000 1.000 1.000 1500381000 15 Triticale, flour 0.005000 1.000 1.000 1500381001 15 Triticale, flour

- babyfood 0.005000 1.000 1.000 1500404000 15 Wheat, bran 0.005000 1.000 0.320 BEAD, 22JUL11 1500402000 15 Wheat, flour 0.005000 1.000 0.320 BEAD, 22JUL11 1500402001 15 Wheat, flour

- babyfood 0.005000 1.000 0.320 BEAD, 22JUL11 1500403000 15 Wheat, germ 0.005000 1.000 0.320 BEAD, 22JUL11 1500401000 15 Wheat, grain 0.005000 1.000 0.320 BEAD, 22JUL11 1500401001 15 Wheat, grain

- babyfood 0.005000 1.000 0.320 BEAD, 22JUL11 2003128000 20C Cotton seed, oil 0.005000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 0.005000 1.000 1.000 2001163000 20A Flax seed, oil 0.005000 1.000 1.000 2001319000 20A Rapeseed, oil 0.005000 1.000 1.000 2001319001 20A Rapeseed, oil

- babyfood 0.005000 1.000 1.000 2001337000 20A Sesame, oil 0.005000 1.000 1.000 8601000000 86A Water, direct, all sources 0.019300 1.000 1.0 00 R. Bohaty 18MAR13 8602000000 86B Water, indirect, all sources 0.019300 1.000 1.000 R. Bohaty 18MAR13Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 15 of 18 Attachment 4. Chronic Results File

US EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for SEDAXANE NHANES 2003

- 2008 2

- day Residue file name: C: \ Users \ wdonovan \ Documents \ DEEM Version 3.16 \ 129223C3.R08 Adjustment factor #2 used. Analysis Date 11

- 05

- 2014/1 3:20:49 Residue file dated: 11

- 05

- 2014/13:13:55 Reference dose (RfD, Chronic) = .11 mg/kg bw/day COMMENT 1: Sedaxane chronic uses with 19 ppb water (PRZM

- GW)

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

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

Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Po pulation 0.000427 0.4% Hispanic 0.000411 0.4%
Non

- Hisp

- White 0.000438 0.4%
Non

- Hisp

- Black 0 .000357 0.3% Non

- Hisp

- Other 0.000488 0.4% Nursing Infants 0.000381 0.3%
Non

- Nursing Infants 0.001387 1.3% Femal e 13+ PREG 0.000400 0.4% Children 1

- 6 0.000569 0.5% Children 7

- 12 0.000372 0.3% Male 13

- 19 0.000304 0.3% Female 13

- 19/NP 0.000333 0.3% Male 20+ 0.000396 0.4% Female 20+/NP 0.000440 0.4% Seniors 55+ 0.000405 0.4% All Infants 0.001076 1.0% Female 13

- 50 0.000420 0.4% Children 1

- 2 0.000636 0.6% Children 3

- 5 0.000543 0.5% Children 6

- 12 0.000391 0.4% Youth 13

- 19 0.000318 0.3% Adults 20

- 49 0.000423 0.4% Adults 50

- 99 0.000413 0.4% Female 13

- 49 0.000420 0.4%

-------------------------- -----------------------------------------------------Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 16 of 18 Attachment 5 . Cancer Results File

US EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for SEDAXANE NHANES 2003

- 2008 2

- day Residue file name: C: \ Users \ wdonovan \ Documents \ DEEM Version 3.16 \ 129223C3.R08 Adjustment factor #2 used. Analysis Date 11

- 05

- 2014/13:21:59 Residue file dated: 11

- 05

- 2014/13:13:55 Q* = 0.0046 COMMENT 1: Sedaxane chronic uses with 19 ppb water (PRZM

- GW) cancer run

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

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

Total Exposure

----------------------------------- Population mg/kg Lifetime risk Subgroup body wt/day (Q*= .0046)

-------------------------------------- ------------- -------------- Total US Population 0.000427 1.96E

- 06

------------------------------------------- ------------------------------------Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 17 of 18 Attachment 6. Acute Results File Food Only

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for SEDAXANE NHANES 2003

- 2008 2

- Day Residue file: 129223A3FO.R08 Adjustment factor #2 NOT used. Analysis Date: 11

- 06

- 2014/09:53:48 Residue file dated: 11

- 06

- 2014/09:51:06 RAC/FF intake summed over 24 hours Run Comment: "sedaxane acute uses food only"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD E xposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population: 0.000165 0.05 0.000273 0.09 0.000505 0.17 All Infants: 0.000274 0.09 0. 000448 0.15 0.000958 0.32 Children 1

- 2: 0.000344 0.11 0.000671 0.22 0.000924 0.31 Children 3

- 5: 0.000302 0.10 0.000460 0.15 0.000705 0.23 Children 6

- 12: 0.000218 0.07 0.000346 0.12 0.000522 0.17 Youth 13

- 19: 0.000148 0.05 0.000218 0.07 0.000335 0.11 Adults 20

- 49: 0.000122 0.04 0.000179 0.06 0.000264 0.09 Adults 50

- 99: 0.000098 0.03 0.000146 0.05 0.000232 0.08 Female 13

- 49: 0.000117 0.04 0.000170 0.06 0.000231 0.08Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D423821



### Page 18 of 18 Attachment 7. Chronic Results File Food Only

US EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for SEDAXANE NHANES 2003

- 2008 2

- day Residue file name: C: \ Users \ wdonovan \ Documents \ DEEM Version 3.16 \ 129223C3FO.R08 Adjustment factor #2 used. Analysis Date 11

- 06

- 2014/09:54:39 Residue file dated: 11

- 06

- 2014/09:52:00 Reference dose (RfD, Chronic) = .11 mg/kg bw/day COMMENT 1: Sedaxane chronic uses food only

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

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

Total Exposure

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

-------------------------- ------------ ------------- ---------------- Total US Population 0.000023 0.0% Hispanic 0.000025 0.0%
Non

- Hisp

- White 0.000022 0.0% Non

- Hisp

- Black 0.000023 0.0% Non

- Hisp

- Other 0.000022 0.0% Nursing Infants 0.000015 0.0%
Non

- Nursing Infa nts 0.000043 0.0% Female 13+ PREG 0.000020 0.0% Children 1

- 6 0.000052 0.0% Children 7

- 12 0.0000 35 0.0% Male 13

- 19 0.000026 0.0% Female 13

- 19/NP 0.000021 0.0% Male 20+ 0.000019 0.0% Female 20+/NP 0.000015 0.0% Seniors 55+ 0.000014 0.0% All Infants 0.000034 0.0% Female 13

- 50 0.000018 0.0% Children 1

- 2 0.000053 0.0% Children 3

- 5 0.000052 0.0% Children 6

- 12 0.000037 0.0%
Y outh 13

- 19 0.000024 0.0% Adults 20

- 49 0.000019 0.0% Adults 50

- 99 0.000015 0.0% Female 13

- 49 0.000018 0.0%

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