Zoxamide Dietary Exposure and Risk Assessment DP# 0416654 

PC Code 101702 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

DRAFT MEMORANDUM 

DATE: 01129/2014 

SUBJECT: Zoxamide: Chronic Aggregate Dietary (Food plus Drinking Water) 

Exposure and Risk Assessments in Support of a Section 3 Registration on 

Dry Onion Bulbs. 

PC Code: 101702 

Decision No.: 476622 

Petition No.: 3F8164 

DP Barcode: 0416654 

Registration No.: 10163-6414 

Regulatory Action: Section 3 Registration 

Risk Assessment Type: Dietary Case No.: NA 

TXRNo.: NA CAS No.: 156052-68-5 

MRIDNo.:NA 40 CFR: §180.567 

FROM: Meheret Negussie, Chemist /1 t:h erd ~~ Risk Assessment Branch IIT (RAB3) 

Health Effects Division (7509P) 

----~- - THROUGH: Thomas Bloem, Chemis~ ~ . 

William Cutchin, Chemist 't~ L;.f!_, f'~ 

Dietary Exposure Science Advisory Council (DESAC) 

Health Effects Division (HED; 7509P) 

and (!4 Christine Olinger, Branch Chief f' /_ ~ 

RAB31HED (7509P) f-~ 

TO: Nancy Tsaur, Chemist/Risk Assessor 

RAB3/HED (7509P) 

and 

Marcel Howard/Hope Johnson, RM#21 

Fungicide Branch 

Registration Division (7505P) 

PageL of 12 
Zoxamide Dietary Exposure and Risk Assessment DP# D416654 

PC Code 101702 

Executive Summary 

Chronic aggregate dietary (food and drinking water) exposure and risk assessment was 

conducted using the Dietary Exposure Evaluation Model software with the Food 

Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 

food consumption data from the U.S. Department of Agriculture's (USDA's) National 

Health and Nutrition Examination Survey, What We Eat in America, 

(NHANES/WWEIA). The analyses were conducted in support of a human health risk 

assessment for the proposed Section 3 requests on dry bulb onions. This memorandum 

was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1. 

Acute and Cancer Dietary Exposure 

No acute dietary toxicity endpoint could be identified based on the toxicology data 

currently available for zoxamide; therefore, an acute assessment was not performed. 

The Cancer Assessment Review Committee (CARC) classified zoxamide as "not likely 

to be carcinogenic to humans;" therefore, a cancer assessment was not performed. 

Chronic Dietary Exposure Results and Characterization 

Chronic (food and drinking water) dietary assessment was conducted assuming tolerance 

level residues for all crops and 100% crops are treated (CT). DEEM version 7.81 default 

processing factors were assumed except for where tolerances were established for 

processed commodities. The estimated drinking water concentration (EDWC) was 

incorporated directly into the dietary assessment. 

The results of the chronic dietary (food and drinking water) analysis indicate that 

exposure and risk does not exceed HED's level of concern for the U.S. population and all 

population subgroups. The dietary exposure for food and water is estimated at 1.5% of 

the chronic Population Adjusted Dose (cPAD) for the general U.S. population and 4.8%, 

of the cPAD for children 1-2 yrs, the most highly exposed population subgroup. 

I. Introduction 

Dietary risk assessment incorporates both exposure and toxicity for any 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 point of departure (POD, NOAEL, LOAEL, e.g.) divided by 

the required uncertainty or safety factors. 

For non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 100% of the cPAD. References which discuss 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: 

Page 2 of 12 
Zoxamide Dietary Exposure and Risk Assessment DP# 0416654 

PC Code 101702 

http:/ /www.epa.gov/fedrgstr/EP A-PEST/2000/J uly/Day-1 2/606l.pdf or see SOP 99.6 

(20-AUG-1999). 

The most recent HED dietary risk assessment for zoxarnide was conducted by A. 

Acierto (DP# D2741 97, 04/09/2001) 

II. Residue Information 

Zoxamide is a broad-spectrum protectant fungicide registered for use on potatoes, grapes, 

tomatoes, and cucurbit vegetables. 

Tolerances for residues ofzoxamide have been established under 40 CFR §180.567(a)(1) 

on grapes at 3.0 ppm, grape raisins at 15.0 ppm, tomatoes at 2.0 ppm, and cucurbit 

vegetables at 1.0 ppm. Tolerances are established under 40 CFR § 180.567(a)(2) for the 

combined residues ofzoxarnide and its metabolites on potatoes at 0.06 ppm, potato flakes 

and chips at 0.30 ppm, and potato wet peel at 0. 10 ppm. 

The residue of concern for tolerance setting and risk assessment is zoxamide for grapes, 

grape processed commodities, tomatoes, and cucumbers. The residues of concern for 

tolerance setting and risk assessment are zoxamide and its metabolites (RH-1452 and 

RH-1455) in/on potatoes and processed potatoes. The residues of concern for tolerance 

setting and risk assessment for the bulb onions are the same as the potatoes. Refer to 

(DP# D416653, M. Negussie, 01/23/2014) for names and structures. 

The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 

2008,2009, and 2010. In general, pesticide residues would not be expected to be found 

in fish unless the pesticide bioaccumulates or has an aquatic use. To determine whether 

or not residues are present in fish, HED now routinely checks PDP monitoring data 

regardless of the pesticide's uses and physicochemical properties. However, PDP did not 

analyze catfish samples for zoxamide. As a result, residues in fish were not included in 

the assessment. 

For the proposed new use on dry bulb onions, tolerance level (0. 7 ppm) is recommended 

(DP# D416653, M. Negussie, 01123/2014). 

Residue Data used for Chronic Assessments: 

HED assumed tolerance level residues and 100%CT for all crops. DEEM version 7.81 

default processing factors were assumed except for where tolerances were established for 

processed commodities. Separate tolerances were set for grape raisin and potato 

granules/flakes; therefore, the processing factor for these commodities was set at 1. The 

EDWC estimated at 65.8 J.lg/L using the PRZM-GW (Pesticide Root Zone ModelGround Water) was incorporated directly into the dietary assessment. 

Page 3 of 12 
Zoxamide Dietary Exposure and Risk Assessment DP# D416654 

PC Code 101702 

III. Percent Crop Treated Information 

1 00% CT was assumed for all crops. 

IV. Drinking Water Data 

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

(DP# 417061, F. Khan, 01/17/2014) and incorporated directly into this dietary 

assessment. Water residues were incorporated in the DEEM-FCID into the food 

categories ''water, direct, all sources" and "water, indirect, all sources." The EDWC for 

ground water using PRZM/GW was estimated to be 65.8 J..tg/L. 

For surface water, coupled models PRZM/EXAMS (Exposure Analysis Modeling 

System) were used to estimate drinking water concentrations. For ground water, the 

SCIGROW (Screening Concentration in Ground Water) and PRZM-GW models were 

used to predict the maximum acute and chronic concentrations. The model and its 

description are available at the EPA internet site: 

http://www .epa.gov I oppefed 1 /models/water/ 

Since this is the first time PRZM-GW modeling was performed for zoxamide, the highest 

application rate for all currently registered zoxamide uses, [1.6 lbs a.i/ A for use on grape 

and potato based on the Gavel® 80WP label (EPA Reg. No.l0163-6413)] was used to 

determine drinking water exposure in groundwater. 

For surface water, the total toxic residues (TTR) EDWCs for onions, garlic and shallots 

did not exceed the recommended peak (acute) concentration of81.30 J..tgfL, annual mean 

(non-cancer chronic) concentration of 54.48 J..tg/L, and the 30 year annual average 

concentration (cancer chronic) of22.84 J..tg/L for use on grape reported in the previous 

drinking water assessment (DP# 266174+, M. Rust, 12/06/2000). The previously 

recommended EDWCs were based on 0.89 PCA (Percent Cropped Area) factor and were 

revised using the current PCA of 0.91 for agricultural uses according to recently 

implemented revised guidance for PCA. 

The estimated PZRM-GW ground water acute concentration of 83.5 J..tg/L and chronic 

concentration of 65.8 J..tg/L for TTR are higher than the previously recommended 

groundwater concentration of2.07 J..tg/L for both acute and chronic values for grape and 

potato (DP# 266174+, M. Rust, 12/06/2000). Therefore, the current EDWCs supersede 

the previously recommended EDWCs for groundwater for the total toxic residue of 

zoxamide. 

The surface and ground water EDWCs for the TTRs are presented in Table 1. 

Page 4 of 12 
Zoxamide Dietary Exposure and Risk Assessment DP# 0 416654 

PC Code 101702 

Table 1. EDWCs Based on Total Toxic Residues of Zoxamide. 

Average Annual 

Drinking Water Crop Scenario Peak Exposure Annual Mean Exposure (J.Lg/L) 

Source (Jlg/L) Exposure (llg!L) 

Recommended EDWCs of Total Toxic Residue (Parent +RH-150721, RH-24549, RH-141288, RH-129151 

and RH-139432) 

Surface water NY Grape STD 

Scenario1 

83.3 54.48 22.84 

Maximum EDWCs of Total Toxic Residue (Parent +RH-150721, RH-24549, RH-141288, RH-129151 and 

RH-139432) on onions (Dry Bulb), Garlic and Shallots Uses. 

Surface water GAOnion STD 10.09 1.20 0. 81 

Scenario1 

Ground water WI corn Scenarioz 83.5 NA 65.8 

Generic ScenarioJ 4.52E-OI 4.52E-Ol 4.52£-01 

PCA of0.91 adjusted EDWCs generated using PRZMIEXAMS model for aerial application 2 Highest EDWCs generated using PRZM-GW model based on 1.60 lbs a.i/A for grape and potato 

[Gavel 80 WP (EPA Reg. No.l0163-6413)) 3 EDWCs generated using SCI GROW model and represent both acute and chronic 

V. DEEM-FCID Program and Consumption Information 

Zoxamide chronic dietary exposure assessment was conducted using the DEEM-FCID, 

Version 3.16, which incorporates 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" (e.g., 

apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruitcooked; 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 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. Exposure is expressed in mg/kg 

body weight/day and as a percent of the cPAD. This procedure is performed for each 

population subgroup. 

Page 5 of 12 
Zoxamide Dietary Exposure and Risk Assessment DP# D416654 

PC Code 101702 

VI. Toxicological Information 

No acute hazard, attributable to a single dose, was identified; therefore, an acute dietary 

endpoint was not selected for quantitative risk assessment. 

The toxicity endpoints pertinent for human health dietary risk assessment are summarized 

in Table 2. 

Table 2. Summary of Toxicological Doses and Endpoints for Zoxamide for Use in Dietary Human 

Health Risk Assessments. 

Uncertainty/ RID, PAD, 

Level of Exposure/ Point of FQPA Concern for Study and Toxicological Effects Scenario Departure Safety Risk Factors Assessment 

Acute Dietary 

(General 

Population, No effect attributed to a single dose was identified in the toxicology database. 

including Infants (HIARC, 12/16/99) 

and Children and 

Females 13-49 

years of age) 

UF A= lOx c RID = 0.48 Body weight changes, increases 

NOAEL= in liver and thyroid weights, and Chronic Dietary 48 UFH=lOx mglkglday increases in alkaline phosphatase. (All Populations) mglkglday FQPASF= cPAD = 0.48 

lx mglkglday Chronic toxicity in dog (MRJD 

no. 44731817) 

Cancer (oral, Classification: ''Not likely to be Carcinogenic to Humans" based on weight of 

evidence of data: No treatment-related increase in tumors incidence was dermal, demonstrated in rat and mouse carcinogenicity studies. No mutagenic concern was inhalation) 

reported in the mutagenicity studies. 

Pomt of Departure (POD) = A data pomt or an estimated pomt that 1s denved 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 = extrapolation from animal to human 

(interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = FQPA Safety Factor. PAD= population adjusted dose (c =chronic). RID= 

reference dose. LOC = level of concern. HED=human equivalent dose. HEC=human equivalent 

concentration. 

VII. Results/Discussion 

As stated above, for 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 5 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+ years. 

Page 6 of12 
Zoxamide Dietary Exposure and Risk Assessment DP# 0416654 

PC Code 101702 

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

The results of the aggregate chronic dietary analysis for food and drinking water are 

below the Agency's level of concern (<100% cPAD) for the general U.S. population 

(1.5% cP AD) and all population subgroups. The most highly exposed population 

subgroup is children 1-2 yrs at 4.8% ofthe cPAD with exposure value of0.023241 

mg/kg/day. The results of the chronic dietary analyses (food plus drinking water) are 

reported in Table 3 below. 

Table 3. Result of Chronic Dietary Exposure and Risk Estimates for Zoxamide. 

Population Subgroup cPAD, Chronic Estimates (Food and Drinking Water) 

mg/kg/day Exposure, mg/kg/day Risk,% cPAD 

U.S. Population O.ol 0.007368 1.5 

All infants 0.010837 2.3 

Children 1-2 yrs 0.023241 4.8 

Children 3-5 yrs 0.018422 3.8 

Children 6-12 yrs 0.009842 2. 1 

Youth 13-19 yrs 0.005483 1.1 

Adults 20-49 yrs 0.006082 l.3 

Adults 50+ yrs 0.005863 1.2 

Females 13-49 yrs 0.005954 1.2 

The populatiOn subgroup w1th the highest est1mated exposure/nsk 1s bolded. 

Vlll. Characterization of Inputs/Outputs 

The dietary exposure and risk estimates are unrefined since they assume tolerance level 

residues, 100 %CT, and include mainly default processing factors except for grape raisin 

and dry potatoes where tolerance was established. Additional refmements may be 

implemented such as the incorporation of%CT data and inclusion of additional empirical 

processing factors. HED concludes that the chronic dietary exposure and risk estimates 

are not underestimated. 

IX. Conclusions 

An unrefmed dietary (food and drinking water) exposure and risk assessment was 

performed for zoxamide. The assumptions of this assessment were tolerance level 

residues, 100% CT, and default DEEM 7.81 processing factors. EDWCs from EFED 

were also included. The chronic dietary (food and drinking water) exposure estimates are 

below BED's level of concern (<100% cPAD) for the general U.S. population and all 

population subgroups. Zoxamide dietary (food and drinking water) risk is 1.5% of the 

cPAD for the U.S. population and 4.8% of the cPAD for 'children 1-2 yrs old', the most 

highly exposed population subgroup. 

Page 7 of 12 
Zoxamide Dietary Exposure and Risk Assessment DP# D416654 

PC Code 101702 

X. List of Attachments 

1. Attachment 1. Chronic Food Plus Water Residue Input file 

2. Attachment 2. Chronic Results files: Food Plus Water 

3. Attachment 3. Chronic Results files: Food Alone 

Page 8 of 12 
Zoxamide Dietary Exposure and Risk Assessment DP# 0416654 

PC Code 101702 

Attachment 1. Chronic Food Plus Water Input File 

Filename : C:\Oocuments and Settings\MNEGUSSI\My Oocuments\OEEM Version 

3.16\Zoxamide\OinionBul bs\Chronic FoodWater2013.R0 8 

Chemical : Zoxamide -

RfO(Chroni c): .48 mg/kg bw/day NOEL(Chronic) : 4S mg/kg bw/day 

RfD(Acute): 0 mg(kg bw/day NOEL(Acute): 0 mg/kg bw/day 

Date created/last modified: 01-30-2014/12:32:00 Program ver. 3.16, 03-08 -d 

Comment: Dry onion bulbs 

EPA 

Code 

Crop 

Grp Commodity Name 

010116Sooo lAB Ginseng, dried 

0103296000 1C Potato, chips 

Full comment: OP# D237S92 

0103297000 1C Potato, dry (granules/ flakes) 

0103297001 1C Potato, dry (granules/ flakes) -b 

0103298000 1C Potato, flour 

0103298001 1C Potato, flour- babyfood 

0103299000 1C Potato, tuber, w/peel 

0103299001 1C Potato, tuber, w/peel-babyfood 

0103300000 1C Potato, tuber, w/o peel 

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

0301165000 3A Garlic, bulb 

Full comment: OP# 0416653 

Garlic, bulb-babyfood 

Onion, bulb 

Onion, bulb-baby f ood 

Onion, bulb, dried 

0301165001 3A 

0301237000 3A 

0301237001 3A 

0301238000 3A 

030123S001 3A 

030133SOOO 3A 

OS01375000 SA 

Onion, bulb, d ried-babyfood 

Shallot, bulb 

Tomato 

Full comment: DP# D2661Sl 

OS01375001 SA Tomato-babyfood 

OS01376000 SA Tomato, paste 

OS01376001 SA Tomato, paste- babyfood 

OS01377000 SA Tomato, puree 

OS01377001 SA Tomato, puree-babyfood 

OS0137SOOO SA Tomato, dried 

OS0137S001 SA Tomato, dried-babyfood 

OS01379000 SA Tomato, juice 

0901075000 9A Cantaloupe 

0901187000 9A Honeydew melon 

0901399000 9A Watermelon 

0901400000 9A Watermelon, juice 

0902021000 9B Balsam pear 

Full comment: OP# D2661S1 

09020SSOOO 9B Chayote, fruit 

0902102000 9B Chinese waxgourd 

0902135000 9B cucumber 

Full comment : OP# 02661S1 

090230SOOO 9B Pumpkin 

0902309000 9B Pumpkin, seed 

0902356000 9B Squash, summer 

0902356001 9B Squash, summer- b abyfood 

0902357000 9B Squash, winter 

0902357001 9B Squash, winter-babyfood 

1304175000 130 Grape 

Ful l comment: DP# D237S92 

1304176000 130 Grape, juice 

1304176001 130 Grape, juice-babyfood 

1304179000 130 Grape, wine and sherry 

S601000000 86A Water, direct, all sources 

Full comment: DP# 266174 

Page 9 of 12 

Def Res 

(ppm) 

0.060000 

0.300000 

0 . 300000 

0 . 300000 

0 . 300000 

0 . 300000 

0.060000 

0.060000 

0 .060000 

0 .060000 

0 . 700000 

0 . 700000 

0 . 700000 

0 . 700000 

0.700000 

0.700000 

0.700000 

2.000000 

2.000000 

Adj.Factors 

#1 #2 

1.000 1.000 

Comment 

1.000 1.000 DP# 02 

1.000 1.000 

1.000 1.000 

1.000 1.000 

1.000 1.000 

1.000 1.000 

1.000 1.000 

l. 000 1. 000 

1.000 1.000 

1.000 1.000 DP# 04 

1.000 1.000 

l. 000 1. 000 

l. 000 1. 000 

9.000 1.000 

9.000 1.000 

1.000 1.000 

1 . 000 1.000 DP# 02 

1. 000 1. 000 

2.000000 5.400 1.000 

2.000000 5.400 1.000 

2.000000 3.300 1.000 

2 . 000000 3.300 1.000 

2.000000 14.300 1.000 

2.000000 14.300 1.000 

2 . 000000 1.500 1 .000 

1 .000000 1.000 1 .000 

1 .000000 1.000 1 .000 

1.000000 1.000 1.000 

1.000 000 1.000 1.000 

1.000000 1.000 1.000 OP# 02 

1 . 000000 1.000 1.000 

1 . 000000 1.000 1.000 

1.000000 1.000 1.000 DP# 02 

1.000000 1.000 1.000 

1.000000 1.000 1 .000 

1 .000000 1.000 1 .000 

1.000000 1.000 1.000 

1.000000 1.000 1.000 

1.000000 1.000 1.000 

3.000000 1.000 1.000 OP# 02 

3.000000 1.200 1.000 

3. 000000 1.200 1.000 

3.000000 1.000 1.000 

0.065SOO 1.000 1.000 DP# 26 
Zoxamide Dietary Exposure and Risk Assessment 

PC Code 101702 

8602000000 868 Water, i ndirect , all sources 

9500177000 0 Grape, l eaves 

9500178000 0 Grape , raisin 

Page 10 of 12 

0 . 065800 

3.000000 

1 5.000000 

DP# 0416654 

1. 000 1.000 

1. 000 1.000 

1.000 1.000 
Zoxamide Dietary Exposure and Risk Assessment 

PC Code 101702 

Attachment 2. Chronic Food Plus Water Output File 

U.S. EPA 

DEEM-FCID Chronic analysis for ZOXAMIDE 

Residue file name: C:\Documents and Settings\MNEGUSSI\My 

3.16\Zoxamide\OinionBulbs\Chronic_FoodWater2013.R08 

DP# 0416654 

Ver. 3.16, 03-08-d 

NHANES 2003-2008 2-day 

Documents\DEEM Version 

Adjustment factor #2 NOT used. 

Analysis Date 01-30-2014/12:37 :25 

Reference dose (RfD, Chronic) = .48 

COMMENT 1: Dry onion bulbs 

Residue file dated : 01-30-2014/12:32:00 

mg/kg bw/day 

Total exposure by population subgroup 

Population 

Subgroup 

Total us Population 

Hispanic 

Non- Hisp-White 

Non- Hisp-Black 

Non- Hisp-Other 

Nursing Infants 

Non-Nursing Infants 

Female 13+ PREG 

Children 1 - 6 

Children 7-12 

Male 13-19 

Female 13-19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1-2 

Children 3-5 

Children 6-12 

Youth 13-19 

Adults 20-49 

Adults 50-99 

Female 13-49 

Total Exposure 

mg/kg Percent of 

body wt/day Rfd 

------------- ---------------- 0.007368 1.5\ 

0.007665 1.6% 

0.007459 1.6% 

0.006575 1.4% 

0.007265 1. 5\ 

0.004593 1.0\ 

0.013625 2.8\ 

0.006386 1.3\ 

0.019551 4.1\ 

0.008956 1. 9\ 

0.005657 1. 2\ 

0.005310 1.1\ 

0.005898 1.2\ 

0.006060 1.3\ 

0.005894 1.2\ 

0.010837 2.3\ 

0.005934 1.2\ 

0. 023241 4 .8\ 

0.018422 3.8\ 

0.009842 2.1\ 

0.005483 1.1% 

0.006082 1.3% 

0.005863 1.2% 

0.005954 1.2% 

Page II of 12 
Zoxamide Dietary Exposure and Risk Assessment 

PC Code 101702 

Attachment 3. Chronic Food Alone Output File 

U.S . EPA 

DEEM-FCID Chronic analysis for ZOXAMIDE 

Residue f ile name: C:\Documents and Settings\MNEGUSSI\My 

3. 16\Zoxamide\OinionBulbs\Chronic_FoodAlone2013 .R08 

DP# D416654 

Ver. 3.16, 03-08-d 

NHANES 2003 - 2008 2-day 

Documents\DEEM Version 

Adjustment factor #2 NOT used. 

Analysis Dat e 01-30-2014/12:35:56 

Reference dose (RfD, Chronic) = .48 

COMMENT 1 : Dry onion bulbs 

Residue file dated: 01-30-2014 /12:33:07 

mg/kg bw/day 

Total exposure by population subgroup 

Population 

Subgroup 

Total US Population 

Hispanic 

Non-Hisp-White 

Non-Hisp-Black 

Non - Hisp- Other 

Nursing Infants 

Non-Nursing Infants 

Female 1 3+ PREG 

Children 1-6 

Children 7- 12 

Male 13 - 19 

Female 13-1 9/NP 

Male 20+ 

Femal e 20+/NP 

Seniors 55+ 

All Infants 

Female 13 - 50 

Children 1-2 

Children 3 - 5 

Children 6-12 

Youth 13-19 

Adul ts 20 - 49 

Adul ts 50 - 99 

Femal e 13 - 49 

Total Exposure 

mg/kg 

body wt/day 

0.005991 

0.006349 

0.006042 

0.005438 

0. 005677 

0.003346 

0.009043 

0.005089 

0 . 017787 

0 . 007807 

0.004710 

0.004249 

0.004614 

0.004 613 

0.004 562 

0 . 007284 

0 . 004563 

0.021254 

0 . 01674 8 

0.008634 

0 . 004478 

0 . 004708 

0.004505 

0 . 004584 

Page 12 of 12 

Percent of 

Rfd 

1. 2% 

1 . 3% 

1.3% 

1. 1% 

1 .2% 

0. 7% 

1.9% 

1. 1% 

3.7% 

1.6% 

1 .0% 

0.9% 

1 . 0% 

1. 0% 

1.0% 

1. 5% 

1. 0% 

4.4% 

3.5% 

1..8% 

0.9% 

1.0% 

0.9% 

1.0%