### UN I TED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D

. C. 20460

MEMORANDUM

Date: 20-FEB-2013 O FFI CE OF CHEMICAL SAF ETY AND POLLUTION P REV ENTION



### SUBJECT: Sedaxane. Acute, Chronic, and Cancer Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to S uppo rt New Seed Treatment Uses on Co rn [Fie ld, Pop, and Sweet], Crop Subgroup 6C [Pea and Bean, Dried Shelled, Except Soybean, Subgroup 6C], Crop Subgroup 20A [Rape seed 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: Sect i o n 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: Mohsen Sahafeyan, Chemist

- 

## 1, 

# ' c-

-

£**~~** Juli e Van Alstine, Environmental Health Scient i st

# ~ 

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

HED (7509P)

TO: Heather Garvie, Risk Manager Reviewer Fungicide Branch Registration Division (7505P)

Page 1 o f 15Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent 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 Evaluatio n Model with the Food Commodity Intake Database ( DEEM

- FCID ) Version 3.16

. This software incor porates 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 per formed to support Section 3 registration requests for seed treatment uses on c orn [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 95 th 

### percenti le of exposure, the estimated risk is <1% of the acute population adjusted dose (aPAD) for the U.S. population
and all population subgroup s.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization A conservative chronic dietary a ssessmen t 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 Dietar y (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 (Q 1 

### *) w as used for quantification of cancer risk, with a Q 1 

### * = 0.0046 4 (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 unreasona ble 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
Pestici des, A User’s Guide,” 21

- JUN

- 2000, web link: http://www.epa.gov/fedrgstr/EPA

PEST/2000/July/Day

- 12/6061.pdf ; or see SOP 99.6 (20

- AUG

- 1999).Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D408793



### Page 3 of 15 The most recent dietary risk assessment for sedaxane was conduct ed by W. Donovan (D398309,
02

- FEB

- 2012)

.

II. Residue Information

T olerance s for sedaxane are established under 40 CFR § 180. 665. The residue of concern in plants , both primary and rotational crops, consi sts 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 S edaxane.
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 0.0 1 Vegetable, foliage of legume, except soybean, subgroup 7A Crop subgroup 6C hay 0.01

Corn forage 0.01 0.0 1 Corn, field, forage

Corn stover 0.01 0.0 1 Corn, field, stover
Popcorn stover 0.01 0.01 Corn, pop, stover
Sorghum forage 0.01 0.0 1 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), the se refinements were not needed for the present analyses.Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D408793



### Page 4 of 15 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 in cluded 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 Fat e and Effects Division (EFED) : “Drinking Water Assessment for the Registration of Sedaxane ” (D382528

, R. Bohaty, 12/2 1 /11 ) and updated values in an email message from R. Bohaty to W. Donovan dat ed 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 b oth isomers of parent sedaxane plus
CSCD668094 and CSCD668095 ( D406945, E. Holman, 19

- DEC

- 2012 )

.

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

. E stimated drinking water concentrations (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. 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 value s w ere 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 r ates 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 parameter guidance (USEPA, 2009). T wo degradates o f 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 a ssumed, consistent with a soybean

- wheat crop rotation practice. The maximum surface and ground w ater EDWCs for use in the human

- health
risk assessment for sedaxane are shown in Table 2

.Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D408793



### Page 5 of 15 T able 2. Maximum Estimate d Surface Water and Groundwater Concentrations for Sedaxane and Major Degradates 1

. 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
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.Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D408793



### Page 6 of 15 VI. Toxicological Information

The Sedaxane risk assessment team in consultation with the ToxSAC (Toxicology Science Advisory Co uncil ) select ed 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 )

.

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, 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. Q 1 *= 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 adver se effect level.
LOAEL = lowest observed adverse effect level. UF = u ncertainty 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 = chro nic). 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 data base, 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 riskSedaxane (129223 ) Dietary Exposure and Risk Assessm ent D408793



### Page 7 of 15 assessment for sed axane

. T here 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. 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.

Results of Acute Dietary (Food and Drinking Wate r) Exposure Analysis A highly conservative acute dietary assessmen t was conducted using tolerance

- level residues, 100% crop treated assumptions, and modeled water numbers. At the 95 th 

### percentile of exposure, the estimated risk is <1% of the acute populati on 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 assessmen t 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 C ancer Dietary (Food and Drinking Water) Exposure Analysis The estimated exposure of the general U.S. population to sedaxane is 0.000222 mg/kg/day.
Multi plying the Q 1 

### * 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 0.000 604 < 1 0.000 2 22 < 1 0.000 2 22 1 x 10 - 6

All Infants (< 1 year old) 0.001 7 84 < 1 0.000 5 22 < 1

N/A N/A Children 1

- 2 years old 0.000 9 90 < 1 0.000 3 63 < 1

Children 3

- 5 years old 0.000 804 < 1 0.000 3 21 < 1

Children 6

- 12 years old 0.000 6 12 < 1 0.000 2 31 < 1

Youth 13

- 19 years old 0.000 505 < 1 0.0001 7 7 < 1Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D408793



### Page 8 of 15 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 0.000 5 71 < 1 0.000 21 5 < 1

Adults 50

- 99 years old 0.000 50 7 < 1 0.000 202 < 1

Females 13

- 49 years old 0.000 5 7 9 < 1 0.000 2 11 < 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 tha t water exposure accounts for
79 % of the tota l 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, 10 0% 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 the se assessment s 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. Ch ronic Residue Input File
Attachment 4 . Chronic Results File
Attachment 5. Cancer Results FileSedaxane (129223 ) Dietary Exposure and Risk Assessm ent D408793



### Page 9 of 15 A ttachment 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
0 603032000 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, kidn ey, 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 1.00 0 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 C orn, 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 1.000Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D408793



### Page 10 of 15 1500381001 15 Triticale, flour

- babyfoo d 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 1.0 00 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 20 A 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 emailSedaxane (129223 ) Dietary Exposure and Risk Assessm ent 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 Exposu re % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population:

0.000604 0.20 0.000985 0.33 0.001777 0.59

All Infants:
0.001784 0.59 0.00240 1 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 0.001 178 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 0.38Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent D408793



### Page 12 of 15 Attachment 3. Chronic Residue Input File

Filen ame: 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 modifi ed: 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 R es 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
06030420 00 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 0.01000 0 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

060334 8000 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, fie ld, 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, f ield, 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 1.00 0 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 1.000Sedaxane (129223 ) Dietary Exposure and Risk Assessm ent 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 W heat, 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 emailSedaxane (129223 ) Dietary Exposure and Risk Assessm ent 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 wat er (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

- Whi te 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%
Childr en 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 Assessm ent 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

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