UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: 20-FEB-2013 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Sedaxane. Acute, Chronic, and Cancer Aggregate Dietary (Food and Drinking 

Water) Exposure and Risk Assessments to Support New Seed Treatment Uses on 

Corn [Field, Pop, and Sweet], Crop Subgroup 6C [Pea and Bean, Dried Shelled, 

Except Soybean, Subgroup 6C], Crop Subgroup 20A [Rapeseed Subgroup 20A], 

and Sorghum. 

PC Code: 129223 

Decision No.: 469252 

Petition No.: 2F8071 

Risk Assessment Type: Dietary Aggregate Risk 

TXRNo.: NA 

MRIDNo.: NA 

DP Barcode: 0408793 

Registration No.: 100-1374 

Regulatory Action: Section 3 Registration 

CaseNo.: NA 

CAS No.: 874967-67-6 

40 CFR: §180.665 

FROM: William H. Donovan, Ph.D., Chemist 

Risk Assessment Branch V 

Health Effects Division (7509P) 

THROUGH: 

Juli

Mohsen 

e Van 

Sahafeyan, 

Alstine, Environmental 

Chemist - 1, 

Health 

'c--£ 

Scientist ~ 

~~ V ~.,; Dietary Exposure Science Advisory Council (DESAC) 

HED (7509P) 

TO: Heather Garvie, Risk Manager Reviewer 

Fungicide Branch 

Registration Division (7505P) 

Page 1 of 15 
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

Page 2 of 15

Executive Summary

Acute, chronic, and cancer aggregate dietary (food and drinking water) exposure and risk 

assessments were conducted using the Dietary Exposure Evaluation Model with the Food 

Commodity Intake Database (DEEM-FCID) Version 3.16. This software incorporates 2003-

2008 food consumption data from the U.S. Department of Agriculture’s National Health and 

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The analyses 

were performed to support Section 3 registration requests for seed treatment uses on corn [field, 

pop, and sweet], crop subgroup 6C [Pea and bean, dried shelled, except soybean, subgroup 6C], 

crop subgroup 20A [Rapeseed subgroup 20A], and sorghum. 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 modeled water numbers. At the 95th percentile of exposure, 

the estimated risk is <1% of the acute population adjusted dose (aPAD) for the U.S. population 

and all population subgroups. 

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

A conservative chronic dietary assessment was conducted using tolerance-level residues, 100% 

crop treated assumptions, and modeled water numbers. The estimated risk is <1% of the chronic 

population adjusted dose (cPAD) for the U.S. population and all population subgroups.

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

Sedaxane has been classified as “Likely to be Carcinogenic to Humans” with respect to 

carcinogenicity (TXR No. 0055854, J. Kidwell, 18-MAY-11). A linear low-dose extrapolation 

model (Q1*) was used for quantification of cancer risk, with a Q1* = 0.00464 (mg/kg/day)-1. The 

cancer risk estimate to the U.S. population is 1 x 10-6.

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, NOAEL, LOAEL, e.g.) 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 

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/EPAPEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG-1999).
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

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The most recent dietary risk assessment for sedaxane was conducted by W. Donovan (D398309, 

02-FEB-2012). 

II. Residue Information

Tolerances for sedaxane are established under 40 CFR §180.665. The residue of concern in 

plants, both primary and rotational crops, consists of the cis- and trans-isomers of the parent 

compound. Residue levels in 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 where appropriate in the dietary exposure analysis. In 

livestock, the residue of concern for risk assessment is parent plus metabolite CSCD658906

(D406945, E. Holman, 19-DEC-2012). However, the proposed seed treatment uses of sedaxane

have been classified as 180.6 (a) (3), no reasonable expectation of finite residues in livestock 

commodities (D407472, W. Donovan, in preparation). The recommended tolerances for 

sedaxane are shown in Table 1. 

Table 1. Tolerance Summary for Sedaxane.

Commodity Proposed Tolerance 

(ppm)

Recommended 

Tolerance (ppm)

Comments; Correct Commodity 

Definition

Foods

Corn (grain) 0.01 0.01 Corn, field, grain

Popcorn (grain) 0.01 0.01 Corn, pop, grain

Sorghum (grain) 0.01 0.01 Sorghum, grain, grain

Crop subgroup 6C, Dried 

shelled pea and bean

0.01 0.01 Pea and bean, dried shelled, except 

soybean, subgroup 6C

Crop subgroup 20A, 

Rapeseed

0.01 0.01 Rapeseed, subgroup 20A

Corn ears 0.01 0.01 Corn, sweet, K+CWHR

Feedstuffs

Crop subgroup 6C forage 0.01 0.01 Vegetable, foliage of legume, except 

Crop subgroup 6C hay soybean, subgroup 7A 0.01

Corn forage 0.01 0.01 Corn, field, forage

Corn stover 0.01 0.01 Corn, field, stover

Popcorn stover 0.01 0.01 Corn, pop, stover

Sorghum forage 0.01 0.01 Sorghum, grain, forage

Sorghum stover 0.01 0.01 Sorghum, grain, stover

Tolerances that need to be proposed

Corn, sweet, forage None 0.01

Corn, sweet, stover None 0.01

For all dietary risk assessments, the recommended tolerances were used and 100% crop treated 

was assumed. Although the Biological and Economic Analysis Division (BEAD) provided 

maximum and average percent crop treated estimates for sedaxane uses on soybean and wheat 

(D389267, C. Doucoure and T. Chandgoyal, 22-JUN-2011), these refinements were not needed 

for the present analyses.
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

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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

The acute, chronic, and cancer assessments assumed 100% crop treated for all registered and 

proposed new use crops.

IV. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the 

Environmental Fate and Effects Division (EFED): “Drinking Water Assessment for the 

Registration of Sedaxane” (D382528, R. Bohaty, 12/21/11) and updated values in an email 

message from R. Bohaty to W. Donovan dated 24-JAN-2013. Water 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 both isomers of parent sedaxane plus

CSCD668094 and CSCD668095 (D406945, E. Holman, 19-DEC-2012). 

There are no monitoring data currently available for sedaxane or its residues of concern in 

drinking water. Estimated drinking water concentrations (EDWCs) were generated using 

computer modeling procedures. The screening model FIRST (FQPA Index Reservoir Screening 

Tool) was used to calculate the surface water EDWCs. Estimated groundwater EDWCs were 

calculated using the screening model SCI-GROW (Screening Concentrations in Ground Water,

version 2.3, 08/08/03), and refined ground water estimates were provided using the provisional 

groundwater model PRZM-groundwater [(GW); November 2, 2001 Prerelease version]. The 

SCI-GROW model provided significantly higher EDWCs than the PRZM-GW model. For 

dietary risk assessment, the refined ground water EDWC values were selected. Additional 

information concerning the water models is available at the EPA internet site:

http://www.epa.gov/pesticides/science/models_pg.htm#aquatic.

Maximum application rates for sedaxane as a high-end estimate of exposure in drinking water 

were modeled based on the proposed labels. Chemical specific and model input values were 

chosen in accordance with current EFED input parameter guidance (USEPA, 2009). Two

degradates of sedaxane (CDCD668094 and CDCD668095) were included in the water modeling, 

and are referred to as total toxic sedaxane residues. 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 sedaxane or total toxic sedaxane residues. To capture the highest use rate possible in a 

given field, two plantings of treated seed were assumed, consistent with a soybean-wheat crop 

rotation practice. The maximum surface and ground water EDWCs for use in the human-health 

risk assessment for sedaxane are shown in Table 2. 
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

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Table 2. Maximum Estimated Surface Water and Groundwater Concentrations for Sedaxane and Major 

Degradates1.

Scenario Surface Water Conc., ppb 2 Groundwater Conc., ppb 3

Acute 1.4 9.9

Chronic & Cancer 0.9 8.4

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

1 EDWCs include residues of concern identified by the ROCKS.

2

From the FIRST model.

3

From the PRZM-GW model using the corn seed treatment maximum label rate of 40 g ai/100 kg seed.

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 

NHANES/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 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 50-99

years old.

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

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

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

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

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

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

For 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 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.
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

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VI. Toxicological Information

The Sedaxane risk assessment team in consultation with the ToxSAC (Toxicology Science 

Advisory Council) selected doses and endpoints for risk assessment. The toxicological doses 

and endpoints used for dietary risk assessment are summarized in Table 3 (D386415, W. 

Donovan et al., 16-FEB-2012).

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 

Assessment Study and Toxicological Effects

Acute Dietary 

(All 

populations, 

including 

children and

women 13-49 

years of age)

NOAEL= 

30 

mg/kg/day

UFA= 10 x

UFH=10 x

FQPA SF = 

1x

Acute RfD = 0.30 

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 

recumbency, decreased BW, decreased 

BWG and food consumption (males). In 

females, weakened condition, swaying 

gait, decreased activity, reduced muscle 

tone and decreased locomotor activity 

and rearing.

Chronic 

Dietary (All 

Populations)

NOAEL= 

11

mg/kg/day

UFA= 10 x

UFH=10 x

FQPA SF = 

1x

Chronic RfD = 0.11

mg/kg/day

cPAD = 0.11 

mg/kg/day

Chronic toxicity study in rats 

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, and 

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. Q1*= 4.64x10-3 (mg/kg/day)-1

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. 

The Agency recommends that the 10X FQPA safety factor for the protection of infants and 

children, be reduced to 1X. The risk assessments conducted for sedaxane were based on the 

most sensitive endpoints in the toxicity database, 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 
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

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assessment for sedaxane. There are no residual uncertainties with regard to pre- and/or postnatal 

toxicity, neurotoxicity, or exposure; therefore, reduction of the 10X FQPA safety factor to 1X is 

appropriate.

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. 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

A highly conservative acute dietary assessment was conducted using tolerance-level residues, 

100% crop treated assumptions, and modeled water numbers. At the 95th percentile of exposure, 

the estimated risk is <1% of the acute population adjusted dose (aPAD) for the U.S. population 

and all subpopulations. Results are shown in Table 4.

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

A highly conservative chronic dietary assessment was conducted using tolerance-level residues, 

100% crop treated assumptions, and modeled water numbers. The estimated risk is <1% of the 

chronic population adjusted dose (cPAD) for the U.S. population and all subpopulations. Results 

are shown in Table 4.

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

The estimated exposure of the general U.S. population to sedaxane is 0.000222 mg/kg/day. 

Multiplying the Q1* of 4.64 x 10-3(mg/kg/day)

-1

by the exposure value results in a cancer risk

estimate of 1 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 0.000604 < 1 0.000222 < 1 0.000222 1 x 10-6

All Infants (< 1 year old) 0.001784 < 1 0.000522 < 1

N/A N/A

Children 1-2 years old 0.000990 < 1 0.000363 < 1

Children 3-5 years old 0.000804 < 1 0.000321 < 1

Children 6-12 years old 0.000612 < 1 0.000231 < 1

Youth 13-19 years old 0.000505 < 1 0.000177 < 1
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

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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

Adults 20-49 years old 0.000571 < 1 0.000215 < 1

Adults 50-99 years old 0.000507 < 1 0.000202 < 1

Females 13-49 years old 0.000579 < 1 0.000211 < 1

1 Highest exposure identified in bold.

VIII. Characterization of Inputs/Outputs

The HED has conducted highly conservative acute and chronic dietary risk assessments. These 

assessments could be refined using highest and mean residue levels instead of tolerance level 

residues and/or percent crop treated data. However, since risks were not of concern, no 

refinements were conducted. Check calculations demonstrate that water exposure accounts for 

79% of the total chronic dietary exposure to sedaxane for general U.S. population ([0.000176 

mg/kg/day ÷ 0.000222 mg/kg/day] * 100). 

IX. Conclusions

The HED conducted acute, chronic, and cancer dietary risk assessments which incorporated 

tolerance level residues, 100% crop treated assumptions, and modeled water numbers. Acute 

and chronic dietary risks to all population subgroups were <1% of the aPAD and cPAD, 

respectively. Additionally, cancer risk to the US population was estimated at 1 x 10-6. HED is 

confident that these assessments do not underestimate risk to the general U.S. population or any 

population subgroup.

X. List of Attachments

Attachment 1. Acute Residue Input File

Attachment 2. Acute Results File

Attachment 3. Chronic Residue Input File

Attachment 4. Chronic Results File

Attachment 5. Cancer Results File
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

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Attachment 1. Acute Residue Input File

Filename: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 3.16\129223A.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: 02-20-2013/09:23:35 Program ver. 3.16, 03-08-d

Comment: sedaxane acute uses with 9.9 ppb water (PRZM-GW) 

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0600347000 6 Soybean, 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 

0600350000 6 Soybean, oil 0.010000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 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, cowpea, seed 0.010000 1.000 1.000 

0603035000 6C Bean, great northern, 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 

0603098000 6C Chickpea, seed 0.010000 1.000 1.000 

0603098001 6C Chickpea, seed-babyfood 0.010000 1.000 1.000 

0603099000 6C Chickpea, flour 0.010000 1.000 1.000 

0603182000 6C Guar, seed 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 1.000 

0603348001 6C Soybean, 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 

1500026000 15 Barley, flour 0.010000 1.000 1.000 

1500026001 15 Barley, flour-babyfood 0.010000 1.000 1.000 

1500027000 15 Barley, bran 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 

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 

1500122000 15 Corn, field, bran 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, field, syrup 0.010000 1.500 1.000 

1500124001 15 Corn, field, syrup-babyfood 0.010000 1.500 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 

1500126000 15 Corn, pop 0.010000 1.000 1.000 

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 1.000 

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 

1500328000 15 Rye, grain 0.010000 1.000 1.000 

1500329000 15 Rye, flour 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 
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

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1500381001 15 Triticale, flour-babyfood 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 

1500402000 15 Wheat, flour 0.010000 1.000 1.000 

1500402001 15 Wheat, flour-babyfood 0.010000 1.000 1.000 

1500403000 15 Wheat, germ 0.010000 1.000 1.000 

1500404000 15 Wheat, bran 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 0.009900 1.000 1.000 R. Boh

 Full comment: R. Bohaty 24JAN13 email

8602000000 86B Water, indirect, all sources 0.009900 1.000 1.000 R. Boh

 Full comment: R. Bohaty 24JAN13 email
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

Page 11 of 15

Attachment 2. Acute Results File

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

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

Residue file: 129223A.R08 Adjustment factor #2 NOT used.

Analysis Date: 02-20-2013/09:28:07 Residue file dated: 02-20-2013/09:23:35

RAC/FF intake summed over 24 hours

Run Comment: "sedaxane acute uses with 9.9 ppb water (PRZM-GW) "

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

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD Exposure % aRfD Exposure % aRfD 

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

Total US Population:

 0.000604 0.20 0.000985 0.33 0.001777 0.59 

All Infants:

 0.001784 0.59 0.002401 0.80 0.003405 1.14 

Children 1-2:

 0.000990 0.33 0.001543 0.51 0.003229 1.08 

Children 3-5:

 0.000804 0.27 0.001146 0.38 0.001752 0.58 

Children 6-12:

 0.000612 0.20 0.000927 0.31 0.001504 0.50 

Youth 13-19:

 0.000505 0.17 0.000801 0.27 0.001164 0.39 

Adults 20-49:

 0.000571 0.19 0.000817 0.27 0.001178 0.39 

Adults 50-99:

 0.000507 0.17 0.000760 0.25 0.001141 0.38 

Female 13-49:

 0.000579 0.19 0.000817 0.27 0.001135 0.38 
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

Page 12 of 15

Attachment 3. Chronic Residue Input File

Filename: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 3.16\129223C.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: 02-20-2013/09:26:21 Program ver. 3.16, 03-08-d

Comment: sedaxane chronic uses with 8.4 ppb water (PRZM-GW)

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0600347000 6 Soybean, 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 

0600350000 6 Soybean, oil 0.010000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 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, cowpea, seed 0.010000 1.000 1.000 

0603035000 6C Bean, great northern, 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 

0603098000 6C Chickpea, seed 0.010000 1.000 1.000 

0603098001 6C Chickpea, seed-babyfood 0.010000 1.000 1.000 

0603099000 6C Chickpea, flour 0.010000 1.000 1.000 

0603182000 6C Guar, seed 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 1.000 

0603348001 6C Soybean, 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 

1500026000 15 Barley, flour 0.010000 1.000 1.000 

1500026001 15 Barley, flour-babyfood 0.010000 1.000 1.000 

1500027000 15 Barley, bran 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 

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 

1500122000 15 Corn, field, bran 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, field, syrup 0.010000 1.500 1.000 

1500124001 15 Corn, field, syrup-babyfood 0.010000 1.500 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 

1500126000 15 Corn, pop 0.010000 1.000 1.000 

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 1.000 

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 

1500328000 15 Rye, grain 0.010000 1.000 1.000 

1500329000 15 Rye, flour 0.010000 1.000 1.000 

1500344000 15 Sorghum, grain 0.010000 1.000 1.000 
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

Page 13 of 15

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 

1500401000 15 Wheat, grain 0.010000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 0.010000 1.000 1.000 

1500402000 15 Wheat, flour 0.010000 1.000 1.000 

1500402001 15 Wheat, flour-babyfood 0.010000 1.000 1.000 

1500403000 15 Wheat, germ 0.010000 1.000 1.000 

1500404000 15 Wheat, bran 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 0.008400 1.000 1.000 R. Boh

 Full comment: R. Bohaty 24JAN13 email

8602000000 86B Water, indirect, all sources 0.008400 1.000 1.000 R. Boh

 Full comment: R. Bohaty 24JAN13 email
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

Page 14 of 15

Attachment 4. Chronic Results File

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

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

Residue file name: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 

3.16\129223C.R08

 Adjustment factor #2 NOT used.

Analysis Date 02-20-2013/09:29:11 Residue file dated: 02-20-2013/09:26:21

Reference dose (RfD, Chronic) = .11 mg/kg bw/day

COMMENT 1: sedaxane chronic uses with 8.4 ppb water (PRZM-GW)

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.000222 0.2%

Hispanic 0.000219 0.2%

Non-Hisp-White 0.000226 0.2%

Non-Hisp-Black 0.000191 0.2%

Non-Hisp-Other 0.000248 0.2%

Nursing Infants 0.000190 0.2%

Non-Nursing Infants 0.000670 0.6%

Female 13+ PREG 0.000205 0.2%

Children 1-6 0.000332 0.3%

Children 7-12 0.000220 0.2%

Male 13-19 0.000175 0.2%

Female 13-19/NP 0.000179 0.2%

Male 20+ 0.000202 0.2%

Female 20+/NP 0.000216 0.2%

Seniors 55+ 0.000197 0.2%

All Infants 0.000522 0.5%

Female 13-50 0.000211 0.2%

Children 1-2 0.000363 0.3%

Children 3-5 0.000321 0.3%

Children 6-12 0.000231 0.2%

Youth 13-19 0.000177 0.2%

Adults 20-49 0.000215 0.2%

Adults 50-99 0.000202 0.2%

Female 13-49 0.000211 0.2%

-------------------------------------------------------------------------------
Sedaxane (129223) Dietary Exposure and Risk Assessment D408793

Page 15 of 15

Attachment 5. Cancer Results File

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

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

Residue file name: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 

3.16\129223C.R08

 Adjustment factor #2 NOT used.

Analysis Date 02-20-2013/09:32:05 Residue file dated: 02-20-2013/09:26:21

Q* = 0.0046 

COMMENT 1: sedaxane chronic uses with 8.4 ppb water (PRZM-GW)

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Lifetime risk

 Subgroup body wt/day (Q*= .0046)

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

Total US Population 0.000222 1.02E-06

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