UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: 12-JUN-201 3 

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 Seed Treatment Uses on 

Potato. 

PC Code: 129223 

Decision No.: 472224 

Petition No.: 2F8113 

Risk Assessment Type: Dietary Aggregate Risk 

TXRNo.: NA 

MRIDNo.: NA 

DP Barcode: 0412218 

Registration No.: 100-1374 

Regulatory Action: Section 3 Registration 

CaseNo.: NA 

CAS No.: 874967-67-6 

40 CFR: §180.665 

FROM: 

Risk 

William 

Assessment 

H. Donovan, 

Branch 

Ph.D., 

V 

Chemist W~wv Jd • V~~ 

Health Effects Division (7509P) 

THROUGH: Douglas Dotson, Ph.D., Che~·st ~.IJ~ Kristin Rury, Biologist ¥J 

Dietary Exposure Science Advisor uncil (DESAC) 

HED (7509P) 

TO: Heather Garvie, Risk Manager Reviewer 

Fungicide Branch 

Registration Division (7505P) 

Page 1 of 15 
Sedaxane(I29223) Dietary Exposure and Risk Assessment D412218 

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 a Section 3 registration request for seed treatment uses of sedaxane on 

potato. 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 95th percentile of exposure, the estimated risk is <I% 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 <1% 

of the chronic population adjusted dose ( cPAD) 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 extrapolation model (Q1*) was used to 

estimate cancer risk, with a Q1 * = 4.64 x 1 o-3 (mg/kg/dayy'. The cancer risk estimate to the U.S. 

population is 1.4 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) (e.g., no observed adverse effect level; NOAEL, lowest 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 

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-12/606l.pdf; or see SOP 99.6 (20-AUG- 1999). 

The most recent dietary risk assessment for sedaxane was conducted by W. Donovan (D408793, 

20-FEB-2013). 

Page 2 of 15 
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

Page 3 of 15

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 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 analysis for all 

food RACs except potato, where the residue was 0.02 ppm. 

For the chronic dietary analysis, it was determined that anticipated residues should be used, as a 

screening approach resulted in cancer risk estimates that exceeded 1 x 10-6. Typically, 

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 0.01 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 proposed 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, the 

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

Potato 0.02 0.02

Potato, wet peel 0.06 0.075

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 Assessment D412218

Page 4 of 15

IV. Drinking Water Data

EDWCs used in the dietary risk assessment were provided by the Environmental Fate 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), Rapeseed (Subgroup 20A), and Potato” (D405391 & D407956, R. Bohaty & J. 

Hetrick, 18-MAR-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. EDWCs were generated using computer modeling procedures. The screening 

model FIRST (FQPA Index Reservoir Screening Tool) was used to calculate the surface water 

EDWCs. Ground water estimates were provided from the ground water model PRZM-GW using 

the GW-GUI (Graphical User Interface, version 1.0, December 11, 2012). For dietary risk 

assessment purposes, the ground water EDWCs were 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#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. The maximum surface and ground water 

EDWCs for use in the human-health risk assessment for sedaxane are shown in Table 2. 

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

Degradates1.

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

Acute 4.1 15.1

Chronic & Cancer 1.2 13

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 other year.
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

Page 5 of 15

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.

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).
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

Page 6 of 15

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, 

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 

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.
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

Page 7 of 15

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.

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 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. 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 <1% 

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

subgroups. The estimated exposure of the general U.S. population to sedaxane is 0.000293 

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 1.4 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 0.000906 < 1 0.000293 < 1 0.000293 1.4 × 10-6

All Infants (< 1 year old) 0.002682 < 1 0.000735 < 1

N/A N/A

Children 1-2 years old 0.001471 < 1 0.000442 < 1

Children 3-5 years old 0.001232 < 1 0.000378 < 1

Children 6-12 years old 0.000922 < 1 0.000273 < 1

Youth 13-19 years old 0.000759 < 1 0.000221 < 1

Adults 20-49 years old 0.000862 < 1 0.000290 < 1

Adults 50-99 years old 0.000766 < 1 0.000282 < 1

Females 13-49 years old 0.000877 < 1 0.000287 < 1

1 Highest exposure identified in bold.
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

Page 8 of 15

VIII. Characterization of Inputs/Outputs

The 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. 

For the chronic and 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 risk estimates 

exceeded 1 × 10-6. A water-only exposure analysis demonstrated that water exposure accounts 

for 93% of the total chronic dietary exposure to sedaxane for the general U.S. population

([0.000272 mg/kg/day ÷ 0.000293 mg/kg/day] * 100). 

IX. Conclusions

The HED 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 assessments made use of 

anticipated residues, percent crop treated information [for wheat, soybean, and potato], default 

processing factors, and screening-level drinking water concentrations. Acute and chronic dietary 

risks to all population subgroups were <1% of the aPAD and cPAD. Additionally, cancer risk to 

the US population was estimated at 1.4 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 D412218

Page 9 of 15

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: 06-04-2013/08:31:28 Program ver. 3.16, 03-08-d

Comment: sedaxane acute uses with 15.1 ppb water (PRZM-GW) 

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

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 

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 

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 

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 
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

Page 10 of 15

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 

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 0.015100 1.000 1.000 R. Bohaty, 18MAR13

8602000000 86B Water, indirect, all sources 0.015100 1.000 1.000 R. Bohaty, 18MAR13

 
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

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: 06-10-2013/09:00:02 Residue file dated: 06-10-2013/08:55:58

RAC/FF intake summed over 24 hours

Run Comment: "sedaxane acute uses with 15.1 ppb water (PRZM-GW) "

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

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD Exposure % aRfD Exposure % aRfD 

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

Total US Population:

 0.000906 0.30 0.001473 0.49 0.002686 0.90 

All Infants:

 0.002682 0.89 0.003558 1.19 0.005173 1.72 

Children 1-2:

 0.001471 0.49 0.002237 0.75 0.004863 1.62 

Children 3-5:

 0.001232 0.41 0.001779 0.59 0.002668 0.89 

Children 6-12:

 0.000922 0.31 0.001447 0.48 0.002264 0.75 

Youth 13-19:

 0.000759 0.25 0.001200 0.40 0.001837 0.61 

Adults 20-49:

 0.000862 0.29 0.001236 0.41 0.001791 0.60 

Adults 50-99:

 0.000766 0.26 0.001145 0.38 0.001770 0.59 

Female 13-49:

 0.000877 0.29 0.001238 0.41 0.001744 0.58 
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

Page 12 of 15

Attachment 3. Chronic Residue Input File

Filename: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 3.16\129223C1.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: 06-10-2013/08:58:11 Program ver. 3.16, 03-08-d

Comment: Sedaxane chronic uses with 13 ppb water (PRZM-GW)

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

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

0103297001 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

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

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

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

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

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 

0603035000 6C Bean, great northern, seed 0.005000 1.000 1.000 

0603036000 6C Bean, kidney, seed 0.005000 1.000 1.000 

0603038000 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 

0603098000 6C Chickpea, seed 0.005000 1.000 1.000 

0603098001 6C Chickpea, seed-babyfood 0.005000 1.000 1.000 

0603099000 6C Chickpea, flour 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 

0603203000 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, seed 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

1500025000 15 Barley, pearled barley 0.005000 1.000 1.000 

1500025001 15 Barley, pearled barley-babyfood 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 

1500027000 15 Barley, bran 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 

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 

1500122000 15 Corn, field, bran 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 1.000 

1500124001 15 Corn, field, syrup-babyfood 0.005000 1.500 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 

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 1.000 
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

Page 13 of 15

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 

1500328000 15 Rye, grain 0.005000 1.000 1.000 

1500329000 15 Rye, flour 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 

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

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

1500404000 15 Wheat, bran 0.005000 1.000 0.320 BEAD, 22JUL11

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 0.013000 1.000 1.000 R. Bohaty, 18MAR13

8602000000 86B Water, indirect, all sources 0.013000 1.000 1.000 R. Bohaty, 18MAR13
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

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\129223C1.R08

 Adjustment factor #2 used.

Analysis Date 06-10-2013/09:03:42 Residue file dated: 06-10-2013/08:58:11

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

COMMENT 1: Sedaxane chronic uses with 13 ppb water (PRZM-GW)

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.000293 0.3%

Hispanic 0.000283 0.3%

Non-Hisp-White 0.000300 0.3%

Non-Hisp-Black 0.000246 0.2%

Non-Hisp-Other 0.000334 0.3%

Nursing Infants 0.000261 0.2%

Non-Nursing Infants 0.000947 0.9%

Female 13+ PREG 0.000275 0.2%

Children 1-6 0.000396 0.4%

Children 7-12 0.000259 0.2%

Male 13-19 0.000212 0.2%

Female 13-19/NP 0.000229 0.2%

Male 20+ 0.000272 0.2%

Female 20+/NP 0.000300 0.3%

Seniors 55+ 0.000276 0.3%

All Infants 0.000735 0.7%

Female 13-50 0.000287 0.3%

Children 1-2 0.000442 0.4%

Children 3-5 0.000378 0.3%

Children 6-12 0.000273 0.2%

Youth 13-19 0.000221 0.2%

Adults 20-49 0.000290 0.3%

Adults 50-99 0.000282 0.3%

Female 13-49 0.000287 0.3%

-------------------------------------------------------------------------------
Sedaxane (129223) Dietary Exposure and Risk Assessment D412218

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\129223C1.R08

 Adjustment factor #2 used.

Analysis Date 06-10-2013/09:06:18 Residue file dated: 06-10-2013/08:58:11

Q* = 0.0046 

COMMENT 1: Sedaxane chronic uses with 13 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 0.000293 1.35E-06

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