### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM

DATE: 14 August 2013

SUBJECT: lpconazole. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action; Food Use

on Legume Vegetables, Group 6 

### (Revised).

PC Code: 125618 

### DP Barcode: 0413901 

### Decision Number: 469403 

### Registration Number: 400-544 

### Petition: 2F8076 

### Regulatory Action: Section 3 

### Risk Assessment Type: Dietary 

### Case Number: 7041 

### TXR Number: NA 

### CAS Number: 125225-28-7 

### MRID Numbers: NA 

### 40CFR: §180.646



### FROM: Will iam T. Drew

,

# Chemist**~** Risk Assessment Branch II (RA B2) 

### Health Effects Division**(HE~), 7~** 


### THRU: William Cutchin, Chemist

# ·'/v**~** ·

# ~H ?---

- Ideliz Negron-Encarnacion

, PhD

, Chemist**/~** Dietary Exposure Science Advisory Cou n cil (DESAC)



### TO: Michael A. Doherty, PhD

, Senior Chemist RAB2/HED

, 7509P and Tony Kish and Dominic Schuler, RM Team 22 Fungicide Branch (FB) Registration Division (RD ), 7505P



### NOTE: These revised dietary ex pos ure assessments were conducted to incorporate updated estimated drinking water concentrations (EDWCs) resulting from the use on gi n seng. The revised E DW Cs replaced those inadvertently used in the previous assessment (D411 023; W.T. Drew; 14 May 2013), which were based on a non-registered use pattern (potatoes).

Page l of 14Ipconazole Dietary Exposure and R is k Assessment DP Barcode D413901

Executive Summary

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

were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database

, Version 3.16 (DEEM-FCID). This software uses 2003-2008 food consumption data from the US Department of Agriculture's (USDA's) National Health and Nu trition Examination Survey, What We Eat in America (NHANES/WWEIA). The analyses

were conducted in su pport of a human-health risk assessment for th e proposed Sec tion 3 use of ipconazole on l egume vegetables, group 6. Per DESAC SOP 2012.1, this memorandum was reviewed by two peer reviewers of the DESAC.

Acute dietary exposure assessment: The acute assessment was conducted only for females 13

- 49
years old. The assumptions utilized for the acute analysis include tolerance-level residues, 100 percent crop treated (%CT) for all commodities, and default processing factors (from DEEM Version 7.8) for corn syr up (1.5X) and peanut butter (1.89X). For the acute assessment, the highest daily groundwater value of0.00101 ppm was used for all drinking wate r inputs. The
acute analysis was conservative and unrefined.

The results ofthe DEEM-FCID acute analysis showed that exposure of females 13-49 to ipconazole was <1% of th e acute population adjusted dose (aPAD). The result is reported at the 95th percentile of exposure, and does no t exceed HED's level of concern (LOC).

Chronic dietary exposure assessment: The assumptions utilized for th e chronic analysis include tol erance-le vel residues, 100 %CT for all commodities, and default p rocessi ng facto rs from DEEM version 7.8 for corn syrup (1.5X) and peanut butter (1.89X). For the chronic assessment, the p os t-break thro ugh average groundwater value of 0.000822 ppm was used for all drinking
water inp u ts. The chronic analysis was conservative and unrefine d.

The results of the DEEM-FCID chronic analysis showed t hat exposures of all population subgroups to ipconazole were <1% of the chronic populat ion adjusted dose ( cP AD). The results do not exceed HED's LOC.

Cancer dietary exposure assessment: Because there is " no evidence of carcinogenicity" for ipconazole, an assessment was not conducted. Cancer risk from dietary exposure is not of

concern.

I. Introduction

Dietary risk assessment incorporates both exposure to, and toxicity of, a given pes t icide. For
acute and chronic assessments, the risk is expressed as a p ercen tage of a maximum acceptable dose (the dose that HED has concluded will result in no unreasonable adverse health effects). This dose is r eferre d to as the population-adjusted dose (PAD). The PAD is equivalent to the

Page 2 of 14Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 3 of 14 

### point of departure (POD )

, such as the NOAEL or LOAEL

, divided by the required uncertai nty and/ or safety factors.

For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticid es web site

, Available Information on Assessing Exposure from Pesticides, A User’s Guide of 21 J une 2000. The web link is http://www.epa.gov/fedrgstr/EPA

- PEST/2000/July/Day

- 12/60 61.pdf

, or see SOP 99.6 (20 A ugust 1999).

The most recent dietary risk assessment for ipconazole was conducted by William T. Drew ( D411023; W.T. Drew; 14 May 2013)

.

II. Residue Information

Tolerances are established for residues of ipconazole under 40CFR §180.646[a]. A Section 3 registration is being requested for an end

- use product (EP) containing ipconazole as the active ingredient (ai)

. This EP, Rancona 3.8FS (EPA Registration #400

- 544)

, is a flowable suspension (FS) formulation of ipconazole containing approximately 41% of the ai by weight, equivalent to 3.77 pounds of ai per gallon (lb ai/gal). The proposed use is on all legume vegetables, group 6, (expanded from uses on soybeans and dried shelled peas and beans, subgroup 6C , except soybean ). Th i s product is for use in commercial seed treatment equipment only ; on

- farm
treatments are prohibited ( it is n ot for use in hopper

- box, planter

- box, slurry

- box or other seed treatment applicatio ns at , o r immediately before

, planting )

. Ipconazole is currently registered for seed treatment use on the Brassica leafy vegetable group, canola, the cucurbit vegetable group, the leafy vegetable (except Brassica ) group, mustard, rape, the root and tuber vegetable group, sorghum, and sunflower; based on the use pattern and residue levels, these are considered non

- food uses. The currently registered uses on cotton, peanut s , soybean s , dry shelled pea s and bean s ( s u bgroup 6C) except soybean , and cereal grains ( g roup 15) except rice are considered food uses

, and have been included in this assessment.

The residues of concern for ipconazole are the parent compound

, along with the common triazole metabolites 1,2,4

- triazole, triazolylalanine, triazolylacetic acid, and triazolylpyruvic acid. The dietary analyses herein address only the parent compound

. The metabolites have been assessed in a separate dietary exposure analysis ( D4 11 38 5 ; T. Morton ; 1 May 20 13 ). The levels of ipconazole used for food inputs in the a cute and chronic assessments are tolerance

- level residues (0.01 ppm for all commodities) that were derived from crop field trials. The trials used ipconazole as a seed treatment at either a 1X or a 5X rate. Even at the exaggerated 5X rate, residues of ipconazole were below the LOQ of 0.01 ppm in all commodities. Both the acute and chronic assessments assume 100% CT and, despite the lack of residues at the 5X rate, includeIpconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 4 of 14 

### default processing factors (fr om DEEM Version 7.8 ) for corn syrup (1.5X) and peanut butter (1.89X).

T hese dietary assessments ar e characterized as screening

- level , unrefined and highly conservative.

I I I. Percent Crop Treated Information

Both the acute and chronic assessments ass umed 100%CT, for the existing uses and the proposed new (unregistered) uses.

IV. Drinking Water Data

A drinking water assessment (DWA) for the current ipconazole action was provided by the Environmental Fate and Effects Division (EFED) in the memorandum Revised Estimated Drinking Water Concentrations (EDWCs) of lpcona zo le from its Proposed New Use by Expansion of Uses from Crop Subgroup 6C to the Entire Crop Group 6 for Use i n Human Health Risk Assessment. ( D 406894 ; M

. A. Ruhman ; 15 July 2013 )

. The EDWCs used in the dietary assessments result from the registered use on ginseng; the requested use on legume vegetables would not result in higher concentration s

. The EDWCs were obtained via PRZM

GW (Pesticide Root Zone Model for GroundWater) modeling. A description of this water model can be found at http://www.epa.gov/oppefed1/models/water/

.

For the acute assessment, the highest daily groundwater value of 0.00 101 ppm was used for the drinking water inputs . The chronic assessment used the post

- breakthrough average groundwater value of 0.000822 ppm

. Water residues were incorporated into DEEM

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

V. DEEM

- FCID Program and Consumption Information

Ipconazole acute and chronic dietary exposure assessments were conducted using DEEM

- FCID ( Version 3.16 ) , which incorpor ates 2003

- 2008 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” ( such as apple pie) are linked to EPA

- defined food commodit ies ( such as 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 US population

, and within population subgroups . However , for
acut e exposure assessment , consumption data are retained as individual consumption events. Based on analysis of the 2003

- 2008 WWEIA consumption data, which took into account dietaryIpconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 5 of 14 

### patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: T he general US 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 a ssessment, an estimate of the residue level in each food or food

form ( such as 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 both in mg/kg b ody 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 proba bilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (only those who reported eating relevant commodities/food forms) and a per

- capita (those who reported eating the relevant commodities

as w ell as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for a nalyses performed at all levels of refinement . However, for deterministic
assessments , any significant differences in user v ersu s per capita ex posure s and risk s are specifically identified and noted in the risk assessment.

VI. Toxicological Information

The toxicological endpoints and points of departure for human health dietary risk assessment are summarized in Table 1, below. After review ing the tox icology database, HED recommended that the FQPA safety factor be reduced to 1X because:

1. The toxicity database is largely complete, with no data gaps for the assessment of the effects of ipconazole following in utero and/or postnatal exposu re. 2. An immunotoxicity study is required for ipconazol e, and is considered a data
gap; however the existing database shows no evidence of immunotoxicity. 3. There is no evidence of neurotoxicity in the available database. An acute neurotoxicity study is not available

, but was waived by the Hazard and Science Policy Council (HASPOC)

, based on the lack of evidence of neurotoxicity in the database, and a developmental neurotoxicity study is not required. The subchronic neurotoxicity study requireme nt is considered to be satisfied by the neurotoxicity assessments performed in both the rat subchronic and chronic toxicity/carcinogenicity studies.Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 6 of 14 

### 4. There is no indication of quantitative or qualitative susceptibility of rats or rabbits to in utero an d/or postnatal exposure to ipconazole. 5. The dietary exposure assessment s are based on models using input parameters which are designed to provide conservative, health protective, high

- end estimates of dietary (food + drinking water) exposure and risk

. 6. At this time, there are no registered residential uses for ipconazole. As a result, infants and children are not expected to be exposed through residential

uses.

TABLE 1 Summary of Toxicological Doses and Endpoints for Use in Ipconazole Dietary Hu man

Health Risk Assessments.
Exposure Scenario Point of

Departure (POD) Uncertainty/

FQPA Safety Factors RfD, PAD,

L O C for Risk Assessment Study and Toxicological Effects

Acute d ietary ( g eneral population, including i nfants and

c hildren) N A * NA NA No appropriate endpoint is available.

Acute d ietary (females 13

- 49 and general population) NOAEL = 10

mg/kg bw/day UF A = 10X

UF H = 10X FQPA SF = 1X Acute RfD = 0.1

mg/kg bw/day

aPAD = 0.1 mg/kg bw/day Co

- critical d evelopmental t oxicity

s tudies in rats and r abbits

.

LOAEL rats = 30 mg/kg bw/day, based on increased visceral and skeletal variations

.

LOAEL rabbits = 50 mg/kg bw/day, based on increased incidence of skeletal variations and malformations

. Chronic d ietary (all populations) NOAEL =

1.5 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X Chronic RfD =

0.015 mg/kg/day

cPAD = 0.015 mg/kg/day Chronic t oxicity study in d ogs

.

LOAEL = 5 mg/kg bw/day, based on skin reddening (both sexes)

, and decreased body weight gain in females

. Cancer (oral, dermal, inhalation) No e vidence of c arcinogenicity

.

* NA = Not Applicable. Point of Departure (P OD) = 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. UF A = ex trapolation from animal to human (int er species). UF H = potential variation among members of the human population (intr a species). FQPA SF = FQPA Safety Factor. a PAD = acute population adjusted dose. c PAD = chronic population adjusted dose. RfD = refere nce dose.Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 7 of 14 

### 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 US population and various population subgroups. The results reported in Table 2 (b elow) are for the general US 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+ years.

Based on the highly

- conservative nature of the acute assessment, evaluation of exposure and risk at the 95 th 

### percentile of exposure is appropriate. For females of child

- bearing age (the only population subgroup of interest for acute analysis), the risk estimate (< 1% aPAD) is well below HED’s LOC

.
For the chronic assessment, risk estimates are below HED’s LOC for all population subgroups

, including infants and children . For children 1

- 2 year s old , the subgroup with the highest exposure estimate, the risk estimate is <1 % of the cPAD.

TABLE 2 Summary of Dietary Exposure and Risk Estimates for Ipconazole. Population Subgroup Acute Dietary (95 th Percentile) Chronic Dietary Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD

General U.S. Population NA * NA 0.000065 <1 All Infants (<1 year old) 0.000122 <1 Children 1

- 2 years old 0.000142 <1 Children 3

- 5 years old 0.000133 <1 Children 6

- 12 years old 0.000095 <1 Youth 13

- 19 years old 0.000063 <1 Adults 20

- 49 years old 0.000058 <1 Adults 50+ years old 0.000047 <1 Females 13

- 49 years old 0.000117 <1 0.000055 <1 * NA = Not Applicable. The population subgroup with the highest risk estimate is in bold typeface

.



### VIII. Characterization of Inputs/Outputs

Both t he acute and chronic dietary analyses are based on highly conservative, health

- protective assumptions ( tolerance

- level residues, 100% CT , and default processing factors )

. They also incorporated model

- derived, conservative estimates of ipconazole residues in drinking water. The resulting exposure and risk estimates should be c onsidered screening

- level estimates that likely overestimate any actual dietary exposures that may occur from the requested uses of ipconazole. Various refinements could be made to the assessments . H owever, as there are no risk estimates of concern, no r efinements were incorporated.Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 8 of 14 

### IX. Conclusions

Acute and chronic dietary risk estimates associated with the requested uses of ipconazole are below HED’s LOC for all population subgroups , including those of infants and children . There are no dietary exposure considerations that would preclude registration of the requested uses

, n or the establishment of tolerances.

X. List of Attachments

Attachment 1. Residue Inputs for the Acute Dietary Exposure Analysis of Ipconazole. A ttachment 2 . Summary of the Acute Dietary Exposure Analysis for Ipconazole. Attachment 3 . Residue Inputs for the Chronic Dietary Exposure Analysis of Ipconazole. Attachment 4. Summary of the Chronic Dietary Exposure Analysis for Ipconazole.Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 9 of 14 

### Atta chment 1. Residue Inputs for the Acute Dietary Exposure Analysis of Ipconazole.

Filename: C: \ Documents and Settings \ wdrew \ My Documents \ IpconazoleDEEM072313AcuteInput.R08 Chemical: Ipconazole RfD(Chronic): .015 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .1 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 07

- 23

- 2013/08:30:25 Program ver. 3.16, 03

- 08

- d Comment: RfDs are PADs. aPAD is for Females 13

- 49 only.

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 1500027000 15 Barley, bran 0.010000 1.000 1.000 1500026000 15 Barley, flour 0.010000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 0.010000 1.000 1.000 150002500 0 15 Barley, pearled barley 0.010000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 0.010000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.010000 1.000 1.000 0603030000 6C Bean, black, seed 0.010000 1.000 1.000 0603032000 6C Bean, broad, seed 0.010000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.010000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.010000 1.000 1.000 0602033000 6B Bean, cowpea, succulent 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 0602037 000 6B Bean, lima, succulent 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 0601043000 6A Bean, snap, succulent 0.010000 1.000 1.000 0601043001 6A Bean, snap, succulent

- babyfood 0.0100 00 1.000 1.000 1500065000 15 Buckwheat 0.010000 1.000 1.000 1500066000 15 Buckwheat, flour 0.010000 1.000 1.000 0603099000 6C Chickpea, flour 0.010000 1.000 1.000 06030 98000 6C Chickpea, seed 0.010000 1.000 1.000 0603098001 6C Chickpea, seed

- babyfood 0.010000 1.000 1.000 1500122000 15 Corn, field, bran 0.010000 1.000 1.000 1500120000 15 Corn, field, f lour 0.010000 1.000 1.000 1500120001 15 Corn, field, flour

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

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

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

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

- babyfood 0.010000 1.500 1.000 1500126000 15 Corn, pop 0.010000 1.000 1.000 2003128000 20C Cottonseed, oil 0.010000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 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 1500226000 15 Millet, grain 0.010000 1.0 00 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 0603256000 6C Pea, dry 0.010000 1.000 1.000 0603256001 6C Pea, dry

- babyfood 0.010000 1.000 1.000 0601257000 6A Pea, edible podded, succulent 0.010000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0.010000 1.000 1.000Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 10 of 14 0602259000 6B Pea, pigeon, succulent 0.010000 1 .000 1.000 0602255000 6B Pea, succulent 0.010000 1.000 1.000 0602255001 6B Pea, succulent

- babyfood 0.010000 1.000 1.000 9500263000 O Peanut 0.010000 1.000 1.000 9500264000 O Peanut, butter 0.010000 1.890 1.000 9500265000 O Peanut, oil 0.010000 1.000 1.000 1500329000 15 Rye, flour 0.010000 1.000 1.000 1500328000 15 Rye, grai n 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 0600350000 6 Soybean, oil 0.010000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.010000 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 0601349500 6AB Soybean, vegetable 0.010000 1.000 1.000 1500381000 15 Triticale, flour 0.010000 1.000 1.000 1500381001 15 Tritica le, flour

- babyfood 0.010000 1.000 1.000 8601000000 86A Water, direct, all sources 0.001010 1.000 1.000 8602000000 86B Water, indirect, all sources 0.001010 1.000 1.000 1500404000 15 Wheat, bran 0.010000 1.000 1.000 1500402000 15 Wheat, flour 0.010000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.010000 1.000 1.000 1500403000 15 Wheat, germ 0.010000 1.000 1.00 0 1500401000 15 Wheat, grain 0.010000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.010000 1.000 1.000Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 11 of 14 

### Attachment 2. Summary of the Acute Dietary Exposure Analysis for Ipconazole.

US EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for IPCONAZOLE NHANES 2003

- 2008 2

- Day Residue file: IpconazoleDEEM072313AcuteInput.R08 Adjustment factor #2 NOT used. Analysis Date: 07

- 23

- 2013/10:25:32 Residue file dated: 07

- 23

- 2013/08:30:25 RAC/FF intake summed over 24 hours Run Comment: "RfDs are PADs. aPAD is for Females 13

- 49 only."

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

Summary calcul ations

-- per capita:

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

---------- -------- ---------- -------- ---------- ------ -- Female 13

- 49: 0.000117 0.12 0.000158 0.16 0.000227 0.23Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 12 of 14 

### Attachment 3. Residue Inputs for the Chronic Dietary Exposure Analysis of Ipconazole.

Filename: C: \ Documents and Settings \ wdrew \ My Documents \ Ipconazole DEEM072313ChronicInput.R08 Chemical: Ipconazole RfD(Chronic): .015 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .1 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 07

- 23

- 2013/08:32:54 Program ver. 3.16, 03

- 08

- d Commen t: RfDs are PADs. aPAD is for Females 13

- 49 only.

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 1500027000 15 Barley, bran 0.010000 1.000 1.000 1500026000 15 Barley, flour 0.010000 1.000 1.000 1500026001 15 Barley, flour

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

- babyfood 0.010000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.010000 1.000 1.000 0603030000 6C Bean, black, seed 0.010000 1.000 1.000 0603032000 6C Bean, broad, seed 0.010000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.010000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.010000 1.000 1.000 0602033000 6B Bean, cowpea, succulent 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 0602037000 6B Bean, lima, succulent 0.010000 1.000 1.000 0603039000 6C Bean, m ung, 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 0601043000 6A Bean, snap, succulent 0.010000 1.000 1.000 0601043001 6A Bean, snap, succulent

- babyfood 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 0603099000 6C Chickpea, flour 0.010000 1.000 1.000 0603098000 6C Chickpea, seed 0.010000 1.000 1.000 0603098001 6C Chick pea, seed

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

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

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

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

- babyfood 0.010000 1.000 1.000 1500124000 15 C orn, field, syrup 0.010000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.010000 1.500 1.000 1500126000 15 Corn, pop 0.010000 1.000 1.000 2003128000 20C Cottonseed, oil 0.010000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 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 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 0603256000 6C Pea, dry 0.010000 1.000 1.000 0603256001 6C Pea, dry

- babyfood 0.010000 1.000 1.000 0601257000 6A Pea, edible podded, succulent 0.010000 1.0 00 1.000 0603258000 6C Pea, pigeon, seed 0.010000 1.000 1.000Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 13 of 14 0602259000 6B Pea, pigeon, succulent 0.010000 1.000 1.000 0602255000 6B Pea, succulent 0.010000 1.000 1.000 0602255001 6B Pea, succulent

- babyfood 0.010000 1.000 1.000 9500263000 O Peanut 0.010000 1.000 1.000 9500264000 O Peanut, butter 0.010000 1.890 1.000 9500265000 O Peanut, oil 0.010000 1.000 1.000 1500329000 15 Rye, flour 0.010000 1.000 1.000 1500328000 15 Rye, grain 0.010000 1.000 1.000 0603348000 6C Soybean, flour 0.010000 1.000 1.000 0603348001 6C Soybean, flour

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

- babyfood 0.010000 1.000 1.000 0600347000 6 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 0601349500 6AB Soybean, vegetable 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 8601000000 86A Water, direct, all sources 0.000822 1.000 1.000 8602000000 86B Water, indirect, all sources 0.000822 1.000 1.000 1500404000 15 Wheat, bran 0.010000 1.000 1.000 1500402000 15 Wheat, flour 0.010000 1.000 1.000 15004020 01 15 Wheat, flour

- babyfood 0.010000 1.000 1.000 1500403000 15 Wheat, germ 0.010000 1.000 1.000 1500401000 15 Wheat, grain 0.010000 1.000 1.000 1500401001 15 Wheat, grain

- baby food 0.010000 1.000 1.000Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413 901

Page 14 of 14 

### Attachment 4. Summary of the Chronic Dietary Exposure Analysis for Ipconazole.

US EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for IPCONAZOLE NHANES 2003

- 2008 2

- day Residue file name: C: \ Documents and Settings \ wdrew \ My Documents \ IpconazoleDEEM072313ChronicInput.R08 Adjustment factor #2 NOT used. Analysis Date 07

- 23

- 2013/10:21:38 Residue file dated: 07

- 23

- 2013/08:32:54 Reference dose (RfD, Chronic) = .015 mg/kg bw/day COMMENT 1: RfDs are PADs. aPAD is for Females 13

- 49 only.

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

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

Total Exposure

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

-------------------------------------- ------------- -------------- -- Total US Population 0.000065 0.4% Hispanic 0.000069 0.5%
Non

- Hisp

- White 0.000065 0.4%
Non

- Hisp

- Black 0.000062 0.4%
Non

- Hisp

- Other 0.000067 0.4% Nursing Infants 0.000055 0.4%
Non

- Nursing Infants 0.000153 1.0% Female 13+ PREG 0.000057 0.4% Children 1

- 6 0.000135 0.9% Children 7

- 12 0.000090 0.6% Male 13

- 19 0.000068 0.5% Female 13

- 19/NP 0.000058 0.4% Male 20+ 0.000056 0.4% Female 20+/NP 0.000051 0.3% Seniors 55+ 0.000046 0.3% All Infants 0.000122 0.8% Female 13

- 50 0.000055 0.4% Children 1

- 2 0.000142 0.9% Children 3

- 5 0.000133 0.9% Children 6

- 12 0.000095 0.6% Youth 13

- 19 0.000063 0.4% Adults 20

- 49 0.000058 0.4% Adults 50

- 99 0.000047 0.3% Female 13

- 49 0.000055 0.4%

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