Date: 

Subject: 

Reviewerff o: 

Through: 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

29-September-2015 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

Etoxazole. Dietary Risk Assessment in Support of the Proposed Tolerances in/on 

Imported Oranges and Orange Oil. 

PC Code: I 07091 DP Barcode: 0426228 

Decision No.: 493877 Registration Nos.: not applicable 

Petition No.: 4E8304 Regulatory Action: tolerance without U.S. registration 

Risk Assessment Type: dietary Case No.: 7616 

TXR No.: not applicable CAS No.: 153233-91-1 

MRID No: none ... 40 CFR: 180.593 

Tom Bloem, Che~~ -

Risk Assessment Branch l/Health Effects Division (RAB 1/HED; 7509P) 

P. Yvonne Barnes, Biologist, RAB6/HED~~~ Thruston Morton, Acting RAB I Branch Chief, RAB l/HED 

Dietary Exposure Science Advisory Council (DESAC) 

George F. Kramer, Ph.D., Senior Chemis~~ • 

RABl/HED (7509P) 

Executive Summary 

In support of the proposed establishment of import tolerances inion oranges and orange oil, a chronic 

dietary risk assessment was conducted using the Dietary Exposure Evaluation Model - Food 

Consumption Intake Database (DEEM-FCID, ver. 3.16) which incorporates food consumption data 

from the United States Department of Agriculture (USDA) National Health and Nutrition Examination 

Survey, What We Eat in America (NHANES/WWEIA; 2003-2008). Acute and cancer analyses were 

not conducted as toxicological effects attributable to a single dose were not identified and etoxazole is 

classified as not likely to be carcinogenic to humans. This memorandum was reviewed by two peer 

reviewers of the DESAC per DESAC Standard Operating Procedure (SOP) 2012.1. 

The chronic analysis assumed I 00% crop treated, tolerance-level residues or tolerance level 

residues adjusted to account for the residues of concern, modeled drinking water estimates, and in 

the absence of empirical data, DEEM ( ver. 7 .81) default processing factors. In addition, Based on 

EFED's conclusion that etoxazole has a high potential to bioaccumulate, residue estimates for 

fish/shellfish were included. The resulting chronic exposure estimates do not exceed HED's level 

of concern 15% chronic population-adjusted dose ( cP AD); children 1-2 years old were the most 

highly exposed subpopulation). 

Page I of 14 
Etoxazole (PC code: I 07091) Dietary Exposure and Risk Assessmenr 0426228 

I. Introd uction 

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 concluded will result in no unreasonable adverse health effects). This dose is 

referred to as the 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 non-cancer chronic 

exposures, HED is concerned when estimated dietary risk exceeds I 00% 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," 2 1-Jun-2000, web link: http:l/wwvv'.regulations.gov/#!documentDetail;D=EPA-HQ-OPP2007-0780-0001; or see SOP 99.6 (20-Aug-1 999). The most recent etoxazole dietary exposure 

analysis can be found in 0 385941 (J. Tyler, 29-Aug-2011). 

H. Residue Information 

Residues of Co11cem - Pla11ts a11d Livestock: Based on the available cotton. eggplant, orange, 

apple. poultry, and ruminant metabolism studies, the confined rotational crop studies, and the 

environmental fate data, HED concludes that the residues of concern for tolerance enforcement and 

risk assessment are as defined in Table I. 

Table I: Summa ry of Metabolites and De!!radatcs of Concern for Risk Assessment and Tolerance Enforcement. 

Matrix Residues of Concern 

Risk Assessment Tolerance Enforcement 

!Primary crops - except cotton ain byproducts and almond hulP etoxazole 

lorimarv crops - cotton J?.in bvoroduct:S'Md almond hull 1 etoxazole and R-3 

!poultry tissue (except liver)l ctoxazole etoxazole 

egg and poultry liver etoxazole and R- 16 

milk and ruminant muscle/fail etoxazolc 

ruminant liver/kidnev2 etoxazole and metabolite I 

water3 ParenL R-8. and R-13 -- rotational ops~ no decision no decision 1 0 283737, J. Tyler, 31-Jul-2003: 0303628. J. Tyler. 30-Mar-2005: 0307178. J. Tyler. 6-Apr-2005: 0289666. J. Tyler. 17-.lun-2003 2 0283737. J. Tyler. 3 l-J ul-2003: 0 289666. J. Tyler, 17-Jun-2003; 0289666. J. Tyler, 17-Jun-2003 

J 0289666. J. Tyler. I 7-Jun-2003 

•

1 0283737, J. Tyler. 3 1-Jul-2003: 0307 178. J. Tyler. 6-Apr-2003: 0353394. 0. Rate. I 8-Nov-2008 

Registered and Proposed Tolerances: Permanent tolerances have been established for residues 

of etoxazole inion several plant and livestock commodities (40CFR§ 180.593). The current 

petition is for the establishment of import tolerances for residues of etoxazole in/on orange and 

orange oil. Based on the submitted data, HED concluded that the fo llowing tolerances for 

residues of etoxazole are appropriate (D4243 75. T. Bloem, 29-Sep-2015): orange - 0.10 ppm 

and orange oil - 1.0 ppm. 

Residues Assumptio11s Incorporated into tile Dietary Assessme11t: The chronic assessment 

assumed tolerance level residues or tolerance level residues adjusted for the residues of concern 

for risk assessment and I 00% crop treated. Since the available processing data indicate that 

residues of etoxazole do not concentrate in apple j uice, cottonseed oil, or orange juice (0 283737. 

J. Tyler, 3 1-Jul-2003; 0424375, T. Bloem, 29-Sep-2015), the DEEM (ver. 7.8 1) default 

processing factors for these commodities were set to I (tangerine juice processing factor was also 

Page 2of 14 
Etoxazole (PC code: I 07091) Dietary Exposure and Risk Assessment 0426228 

set to I based on the orange juice data). An adequate grape processing study is not available. 

However, based on the theoretical concentration factors for grape juice and raisins (OCSPP 

860.1520) and the highest-average field trial (HAFT) for grapes, HED previously determined 

that a 1.5 ppm grape raisin tolerance was required and a grape juice tolerance was unnecessary 

(D303628, J. Tyler, 30-Mar-2005). Based on this decision and since tolerance level residues are 

being assumed, the DEEM (ver. 7.81) default processing factors for grape juice and raisin were 

set to 1. Adequate processing studies were not provided for stone fruit commodities, thus default 

DEEM (ver. 7.81) processing factors were set for appropriate stone fruit commodities, except 

dried prune for which the processing factor was set to 1 because a separate tolerance was 

established for the processed commodity. 

Fislz/Shelljish: Tolerances for residues of etoxazole in/on fish/shellfish have not been established. 

The USDA PDP monitored etoxazole residues in catfish (2008, 2009, and 2010) and salmon 

(2013) with no residues detected (LOD = 0.001-0.005 ppm). Based on EFED's conclusion that 

etoxazole has a high potential to bioaccumulate (0311941, J. Melendez, 31-May-2005), HED 

included residues in fish/shellfish at the LOD for the PDP data (0.005 ppm). 

Table2: Established and HED-Recommended Tolerances and Residue Values for Risk Assessment Purposes. 

Recommended/ Residue Values for 

Commodity Establ ishcd Chronic Dietary DEEM (ver. 7.8 1) Default Processing Factors Tolerance Exposure 

(ppm)I Assessment (ppm) 1 

Oranges 0. 10 0. 10 

The orange juice processing factor was reduced to I based on 

empirical data (0424375, T. Bloem, 29-Sep-20 I 5). 

Orange oil 1.0 1.0 Separate tolerance established therefore the processing factor 

reduced to I. 

Avocado 0.20 0.20 --

Berry. low growing, subgroup 13-07G 0.50 0.50 

The default processing factor for cranberry juice (I. lx) was 

retained. 

Caneberry subgroup 13-07A 1.5 1.5 -- Canistel 0.20 0.20 -- An adequate field corn processing study is available and 

Corn, field, grain 0.01 0.01 indicates that residues do not concentrate in com starch 

(translated to com grain sugar/hfcs), grits. flour or meal 

(0385940, J. Tyler, 23-Scp-2011 ); this same study indicated 

Corn. field, refined oil 0.03 O.Q3 that residues do concentrate in oil which led to the refined oil 

tolerance. 

Corn, pop. grain 0.01 0.01 --

Cot1on, undelinted seed 0.05 0.05 

Available processing data indicate that residues do not 

concentrate in cononsecd oil (0283737, J. Tyler, 31-Jul-2003). 

Available processing data indicate that residues do not 

concentrate in apple juice (0283737. J. Tyler, 3 l-Jul-2003). 

Fruit, pome, group 1 I 0.20 0.20 Therefore the apple juice default processing factor was 

reduced to I; The default dried apple (8.0x) and pear (6.25x) 

processing factors were retained 

Page 3of14 
Etoxazole (PC code: I 07091) Dietary Exposure and Risk Assessment 0 426228 

Tablc2: Established and HED-Recommended Tolerances and Residue Values for Risk Assessment Purposes. 

Recommended! Residue Values for 

Commodity Established Chronic Dietary DEEM (vcr. 7.8 1) Default Processing Factors Tolerance Exposure 

(ppm)I Assessment (ppm)1 

A grape processing study has not been submillcd: however. the 

available information indicates that the subgroup tolerance is 

Fruit. small vine climbing. except 0.50 0.50 adequate to cover residues in grape juice (0339039. J. Tyler. 

fuzzy kiwifruit. subgroup 13-07F I 7-Jul-2009). Therefore the default grape juice processing 

factor was reduced to I. A separate grape raisin tolerance is 

established (sec below). 

The default processing factor were retained for dried apricot 

r:ruit, stone, group 12. excepl plum 1.0 1.0 (6.0x). cherry juice ( I .5x). and dried peaches (7.0x). eparatc 

tolerances for plum and dried prune are established (sec 

below). 

Grape. raisin 1.5 1.5 

Default processing factor reduced lo I because a s1:parate 

tolerance is established. 

I lop. dried cones 7.0 7.0 -

Mango 0.20 0.20 -- Melon subgroup 9A 0.20 0.20 - Milk. fat 0.01 0.01 -- Nut. tn:e, group 14 0.01 0.01 -

Papaya 0.20 0.20 

The default dried papaya ( I .8x) and papaya juice (I .5x) 

processing factors were retained. 

Pepper/eggplant subgroup 8- 1 OB 0.20 0.20 -- Peppennint. oil 20 20 -- Peppermint. tops 10 10 -

Pistachio 0.01 0.01 -- Plum 0. 15 0.15 --

Since a separate tolerance is established. the default processing 

Plum. prune. dried 0.30 0.30 factor for dried prunt: was reduced to 1. The default 

plum/prune juice ( l .4x) processing factor was reiained. 

Sapodilla 0.20 0.20 -- Sapote, black 0.20 0.20 -- Sapole. mamey 0.20 0.20 -- SpearminL oil 20 20 -

SpeanninL !Ops 10 10 -- Squash/cucumber subgroup 9B 0.02 0.02 --

Star apple 0.20 0.20 --

!rhe default tangerine juice processing factor was reduced to I 

Tangerine' 0. 10 0.10 based on the orange processing study which indicated that 

residues do not concentrate in juice .. 

Tea, dried* 15 15 -- A tomato processing study has not been submined: the default 

Tomato 0.20 0.20 tomato dried ( 14.3x).juice (l.Sx). puree (3.3x). and paste 

(5.4x) processing factors were retained. 

Page 4of 14 
Etoxazole (PC code: 107091) Dietary Exposure and Risk Assessment 0426228 

Table2: Established and HED-Recommended Tolerances and Residue Values for Risk Assessment Purposes. 

Recommended/ Residue Values for 

Commodity Established Chronic Dietary DEEM (vcr. 7.81 ) Default Processing Factors Tolerance Exposure 

(ppm)l Assessment (ppm)1 

Fat and meat byproducts (cattle. goat. 0.02 O.Q2 -- horse, and sheep )2.4 

Liver (cattle, goat, horse, and sheep)2 0.01 0.01 -- Kidney (cattle, goat, horse, and sheep )

3 NA 0.0067 -- Fish/shellfish5 -- 0.005 -- 1 The residue of concern for tolerance enforcement and risk assessment are the same for all commodities except rummant hver and 

kidney. for ruminant liver and kidney, the residue of concern for tolerance enforcement is parent only and the residue of concern for 

risk assessment is parent and Metabolite 1. 2 The calculated residue level of etoxazole and Metabolite I in ruminant liver was less than the HED-recommended tolerances of0.01 

ppm: therefore tolerance-level residues were assumed (038594 1, J. Tyler, 23-Sep-2011 ). 3 The results of the submitted livestock feeding study indicate that tolerances are not needed for ruminant kidney (40 CFR 

§ J 80.6(a)(3)): however, as quantifiable residues of Metabolite I (a residue of concern for risk assessment purposes) were measured in 

kidney in the feeding study, kidney (parent and Metabdite I) was included in the risk assessment (0385941 , J. Tyler, 23-Scp-2011) 4 Although a tolerance in/on ruminant meat byproducts has not been established, HED determined that the fat residue should be applied 

10 meat byproducts. 5 Tolerances for residues of ctoxazole in/on fish/shellfish have not been established. The USDA PDP monitored ctoxazole 

residues in catfish (2008. 2009. and 20 I 0) and salmon (2013) with no residues detected (LOO = 0.001-0.005 ppm). Based on 

EFED's conclusion that etoxazole has a high potential to bioaccumulate (031194 1, J. Melendez, 31-May-2005), HED included 

residues in fish/shellfish at lhe LOO for the PDP data (0.005 ppm). 

III. Drinking Water Data 

The Environmental Fate and Effects Division (EFED) provided Estimated Drinking Water 

Concentrations (EDWCs) of etoxazole and the metabolites of concern (R-8 and R-13) in surface 

and ground water using the Food Quality Protection Act (FQPA) lndex Reservoir Screening 

Tool (FIRST) and Pesticide Root Zone Model - Ground Water (PRZM-GW) models, 

respectively (D426353, J. Melendez, 23-Mar-2015). The assessment was based on the 

established mint use which has a maximum proposed seasonal application rate of 0.36 lb ai/acre. 

EFED calculated the l-in-10-year estimated annual mean non-cancer chronic EDWCs for 

etoxazole, R-8, and R-13 in surface and ground water of 4.761 ppb and 0.746 ppb, respectively. 

Table 3 is a summary of the EDWCs provided by EFED. 

Table 3: E DWCs for Etoxazole a nd Metabolites for C hronic Analysis 

Source Etoxazole (ppb) R-8 (ppb) R-13 (ppb) Total (ppb) Application Scenario 

Surface Water (FIRST) 0.618 4.08 0.063 4.76 1 One application to mint at 

Ground Water (PRZM GW) -- -- -- <0.1 0.36 lb ai/acre/season. 

IV. DEEM-FCIDTM Program and Consumption Information 

Chronic dietary exposure assessments were conducted using the DEEM-FCID (ver. 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 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 

Page 5of14 
Etoxazole (PC code: I 07091) Dietary Exposure and Risk Assessment 0 426228 

population subgroups. 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 (<l 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 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 fo1m 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. 

V. Toxicological Information 

Etoxazole was presented to the HED Hazard Identification Assessment Review Committee 

(HIARC) on 4-Feb-2003 (TXR No. 0051659, PY Shah, l 9-Mar-2003). Based on the HIARC 

conclusions and the etoxazole risk assessment team's evaluation of the hazard and exposure data, 

the team recommended that the FQPA Safety Factor be reduced to lx. Table 4 is a summary of 

the toxicological doses and endpoints selected for dietary exposure assessment. 

Table 4: Summary of Toxicological Doses and Endpoints fo r Etoxazole for Use in Human-Health Risk 

Assessments. 

Point of Uncertainty/ FQPA RID, PAD. LOC 

Exposure Scenario Departure Safety Factors for Risk Study and Toxicological Effects 

Assessment 

Acute Dietary (General population, A dose and endpoint attributable to a single dose were not identified in the database including the 

including infants and children) developmental toxicity studies. 

Acute Dietary (Females 13-49 A dose and endpoint attributable to a single dose were not identified in the database including the 

years of age) developmental toxicity studies. 

Chronic Oral Toxicity Study- Dog 

UFA= IOX LOAEL = 23.5 mg/kg/day based upon 

Chronic Dietary (All populations) NOAEL = UFH = IOX cPAD=cRID= increased alkaline phosphatase activity. 

4.62 mg/kg/day 0.046 mg/kg/day increased liver weights, liver enlargement 

FQPA SF= IX (females), and incidences of centrilobular 

hepatocellular swelling in the liver. 

Cancer (oral. dennal, inhalation) HED classified ctoxazole as "not likely to be carcinogenic to humans'' according to EPA 

Proposed Guidelines/or Carcinogen Risk Assessment (April 10. 1996). 

Pomt of departure (POD) = A data pomt or an estimated pomt that 1s derived from observed dOS(}response data and used to mark the begmnmg 

of extrapolation to dctennine risk associated with lower environmentally relevant human exposures. NOA EL = no-observed adverse·cffcct level. 

LOAEL = lowest-observed adverse-effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population intra~pecies). FQPA SF= FQPA Safety Factor. PAD= populationadjusted dose (a = acute. c = chronic). Rm = reference dose. 

Page 6of14 
Etoxazole CPC code: 107091) Dietary Exposure and Risk Assessment 0426228 

VI. Results/Discussion 

The chronic dietary analysis resulted in exposure estimates of Sl 5% cPAD (children 1-2 years old 

were the most highly exposed population subgroup); therefore, chronic exposure to etoxazole does not 

exceed HED's level of concern. Table 5 is a summary of the results of the chronic analysis. 

Table 5: Summary of Chronic Dietary (food and water) Exposure a nd Risk Estimates. 

Population Subgroup cPAD (mg/kg/day) Chronic 

Exposure (mg/kg/day) %cPAD 

general U.S. Population 0.001650 4 

a ll Infants (< I year old) 0.003650 8 

children J-2 years old 0.006865 15 

children 3-5 years old 0.004616 10 

children 6-1 2 years old 0.046 0.0022 16 5 

youth 13-19 years old 0.00 11 07 2 

adults 20-49 years old 0.00 1209 3 

adults 50-99 years old 0.001278 3 

fema les 13-49 years old 0.001 171 3 

Vil. Characterization of Inputs/Outputs 

The chronic analysis is conservative as it assumes tolerance level residues and 100% crop treated. In 

addition, the chronic analysis included residues in processed tomato commodities; residues in 

processed tomato commodities are unlikely, particularly for a chronic analysis, as the use is limited to 

greenhouse grown tomatoes which are usually reserved for the fresh market. 

VIII. Conclusions 

The chronic dietary analysis resulted in exposure estimates of Sl 5% cPAD (children 1-2 years 

old were the most highly exposed population subgroup); therefore, chronic exposure to etoxazole 

does not exceed HED's level of concern. This assessment is conservative in that it assumed 

tolerance level residues and 100% crop treated. 

Attachment 1: DEEM-FCIDTM chronic residue fi le. 

Attachment 2: DEEM-FCIDTM chronic exposure estimates. 

Page 7of14 
Etoxazole (PC code: I 07091) Dietarv Exposure and Risk Assessment 

Attachment 1. Residue File for Chronic DEEM-FCJDTM Analysis. 

Filename : C: \Users\tbloem\Documents\work\etoxazole\citr us import\107091C. R08 

Chemical : Etoxazole 

RfD(Chronic) : . 046 mg/kg bw/day NOEL(Chronic) : 4 . 62 mg/ kg bw/day 

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

0426228 

Date created/last modified : 05- 07-2015/09 : 27 : 51 Program ver . 3 . 16, 03- 0S- d 

Comment : Section 3 request for use on field corn and pop corn . 

EPA 

Code 

Crop 

Grp Commodity Name 

Def Res 

(ppm) 

Adj . Factors Comment 

~1 ~2 

0S01375000 SA Tomato 0 . 200000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

OS01375001 SA Toma to-babyfood 

Full comment : Parent only 

0801376000 SA Tomato, paste 

OS01376001 SA Tomato, paste-babyfood 

0801377000 SA Tomato, puree 

0801377001 SA Tomato, puree-babyfood 

0801378000 8A Tomato, dried 

0801378001 BA Tomato, dried-babyfood 

0801379000 BA Tomato, juice 

0802148000 BBC Eggplant 

Full comment : Parent only 

0802234000 SBC Okra 

Full comment : Parent only 

0802270000 BB Pepper, bell 

Full comment : Parent only 

0802270001 SB Pepper, bell- babyfood 

Full comment : Parent only 

OB02271000 SB Pepper, bell, dried 

Full comment : Parent only 

0802271001 SB Pepper, bell, dried- babyfood 

Full comment : Parent only 

0802272000 BBC Pepper, nonbell 

Full comment : Parent only 

OS02272001 SBC Pepper, nonbell- babyfood 

Full comment : Parent only 

OS02273000 SBC Pepper, nonbell , dried 

Full comment : Paren t on ly 

0901075000 9A Cantaloupe 

Full comment : Parent only 

09011S7000 9A Honeydew melon 

Full comment : Parent only 

0901399000 9A Watermelon 

Full comment : Parent only 

0901400000 9A Watermelon, juice 

Full comment : Parent only 

0902021000 9B Balsam pear 

Full comment : Parent only 

09020SBOOO 9B Chayote, fruit 

Full comment : Paren t o nly 

0902102000 9B Chinese waxgourd 

Full comment : Parent only 

0902135000 9B Cucumber 

Full comment : Parent only 

090230SOOO 9B Pumpkin 

Full comment : Parent only 

0902309000 9B Pumpkin , seed 

Full comment : Parent only 

0902356000 9B Squash, summer 

Page 8of14 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 200000 

0 . 020000 

0 . 020000 

0 . 020000 

0 . 020000 

0 . 020000 

0 . 020000 

0 . 020000 

1 . 000 

5 . 400 

5 . 400 

3 . 300 

3 . 300 

14 . 300 

14 . 300 

1 . 500 

1 . 000 

1 . 000 

1. 000 

l. 000 

1. 000 

1 . 000 

1 . 000 

1. 000 

l. 000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1. 000 

l. 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1. 000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1. 000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1. 000 

Parent 

!?a rent 

Parent 

Parent 

!?a rent 

Parent 

Parent 

!?a rent 

Parent 

Parent 

!?a rent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 
Etoxazole (PC code: 107091) Dietary Exposure and Risk Assessment 0426228 

Full comment : Parent only 

0902356001 9B Squash, summer- baby food 0 . 020000 l. 000 1 . 000 Parent 

Full comment : Parent only 

0902357000 9B Squash, winter 0 . 020000 l. 000 1 . 000 Parent 

Full comment : Parent only 

0902357001 9B Squash, winter-babyfood 0 . 020000 1. 000 1. 000 Parent 

Full comment : Parent only 

1001108000 lOA Citrus, oil 1 . 000000 l. 000 l. 000 parent 

Full comment : parent only 

1001240000 lOA Orange 0 . 100000 1 . 000 1. 000 parent 

Full comment : parent only 

1001241000 lOA Orange , juice 0 . 100000 1. 000 l. 000 parent 

Full comment : parent only 

1001241001 lOA Orange , juice- babyfood 0 . 100000 1. 000 1. 000 parent 

Full comment : parent only 

1001242000 lOA Orange , peel 0 . 100000 1 . 000 1 . 000 parent 

Full comment : parent only 

1001369000 lOA Tangerine 0 . 100000 1 . 000 1. 000 Parent 

Full comment : Parent only 

1001370000 lOA Tangerine , jui ce 0 . 100000 1. 000 1. 000 Parent 

Full comment : Parent only 

1100007000 11 Apple , fruit with peel 0 . 200000 1. 000 1. 000 Parent 

Full comment : Parent only 

1100008000 11 Apple , peeled fruit 0 . 200000 1. 000 1. 000 Parent 

Full comment : Parent only 

1100008001 11 Apple , peeled fruit-babyfood 0 . 200000 1. 000 1. 000 Parent 

Full comment : Parent 

only 

1100009000 11 Apple , dried 0 . 200000 8 . 000 1 . 000 Parent 

Full comment : Parent only; Default processing factor set to l. 

1100009001 11 Apple , dried- babyfood 0 . 200000 8 . 000 1. 000 Paren t 

Full comment : Parent only ; Default processing factor set to 1. 

1100010000 11 Apple , juice 0 . 200000 1. 000 1. 000 Parent 

Full comment : Parent only; Default processing factor set to 1. 

1100010001 11 Apple , juice- baby food 0 . 200000 1. 000 l. 000 Parent 

Full comment : Parent only ; Default processing factor set to 1. 

1100011000 11 Apple , sauce 0 . 200000 1. 000 l. 000 Parent 

Full comment : Parent only 

1100011001 11 Apple , sauce- babyf ood 0 . 200000 1. 000 1. 000 Parent 

Full comment : Parent only 

1100129000 11 Crabapple 0 . 200000 1. 000 1. 000 Parent 

Full comment : Parent only 

1100210000 11 Loquat 0 . 200000 1. 000 1 . 000 Parent 

Full comment : Parent only 

1100266000 11 Pear 0 . 200000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1100266001 11 Pear- baby food 0 . 200000 1 . 000 1. 000 Parent 

Full comment : Parent only 

1100267000 11 Pear, dried 0 . 200000 6 . 250 1. 000 Parent 

Full comment : Parent only; Default processing factor . 

1100268000 11 Pear, juice 0 . 200000 1. 000 1. 000 Parent 

Full comment : Parent only 

1100268001 11 Pear, juice-babyfood 0 . 200000 1. 000 1 . 000 Parent 

Full comment : Parent only 

1100310000 11 Quince 0 . 200000 1. 000 l. 000 Parent 

Full comment : Parent only 

1201090000 12A Cherry 1. 000000 1. 000 1 . 000 Parent 

Full comment : Parent only 

1201090001 12A Cherry-babyf ood 1 . 000000 1 . 000 1. 000 Parent 

Full comment : Parent only 

1201091000 12A Cherry, juice 1 . 000000 1 . 500 1. 000 Parent 

Full comment : Parent only; Default processing factor . 

1201091001 12A Cherry, juice-babyfood 1. 000000 1. 500 1. 000 Parent 

Page 9of14 
Etoxazole (PC code: I 07091) Dietary Exposure and Risk Assessment 0426228 

Full comment : Parent only; Default processing factor . 

1202012000 12B Apricot 1. 000000 1. 000 1 . 000 Parent 

Full comment : Parent only 

1202012001 128 Apricot-babyfood 1 . 000000 1.000 1 . 000 Parent 

Full comment : Parent only 

1202013000 128 Apricot , dried 1 . 000000 6 . 000 1 . 000 Parent 

Full comment : Parent only; Default processing factor . 

1202014000 128 Apricot , juice 1 . 000000 1. 000 1. 000 Parent 

Full comment : Parent only 

1202014001 128 Apricot , juice- baby food 1 . 000000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1202230000 128 Nectarine 1 . 000000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1202260000 128 Peach 1 . 000000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1202260001 12B Peach-baby food 1 . 000000 1. 000 1. 000 Parent 

Full comment : Parent only 

1202261000 128 Peach, dried 1 . 000000 7 . 000 1 . 000 Parent 

Full comment : Parent only; Default processing factor . 

1202261001 128 Peach , dried-baby food 1 . 000000 7 . 000 1. 000 Parent 

Full comment : Parent only; Default processing factor . 

1202262000 128 Peach, juice 1 . 000000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1202262001 128 Peach, juice-babyfood 1 . 000000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1203285000 12C Plum 0 . 150000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1203285001 12C Plum-baby food 0 . 150000 1. 000 1. 000 Parent 

Full comment : Pare nt only 

1203286000 12C Plum, prune, fresh 0 . 150000 1. 000 1. 000 Parent 

Full comment : Parent only 

1203286001 12C Plum, prune, fresh - baby food 0 . 150000 1. 000 1 . 000 Parent 

Full comment : Parent only 

1203287000 12C Plum, prune, dried 0 . 300000 1 . 000 1 . 000 Parent 

Full comment : Parent only; Default PF set to 1 . 

1203287001 12C Plum, prune, dried- baby food 0 . 300000 1 . 000 1 . 000 Parent 

Full comment : Par:e:-it only; Default PF set to 1. 

1203288000 12C Plum, prune, juice 0 . 150000 1. 400 1 . 000 Parent 

Full comment : Parent only; 

1203288001 12C Plum, prune, juice-babyfood 0 . 150000 1. 400 1 . 000 Parent 

E'ull comment : Pare nt onl y ; 

1301055000 13A Blackberry 1 . 500000 1. 000 1 . 000 Parent 

Full comment : Parent only 

1301056000 13A Blackberry, juice 1 . 500000 1. 000 1 . 000 Parent 

Full comment : Parent only 

1301056001 13A Blackberry, juice- baby food 1 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1301058000 13A Boysenberry 1 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1301208000 13A Loganberry 1 . 500000 1 . 000 1 . 000 Parent. 

Full comment : Parent only 

1301320000 13A Raspberry 1 . 500000 1. 000 1 . 000 Parent. 

Full comment : Parent only 

1301320001 13A Raspberry-babyfood 1 . 500000 1. 000 1. 000 Parent 

Full comment : Parent only 

1301321000 13A Raspberry, juice 1. 500000 1. 000 1 . 000 Parent 

Full corrunent : Parent only 

1301321001 13A Raspberry, j uice- babyfood 1 . 500000 1 . 000 1 . 000 Parent 

Full commen L : Parent only 

1302057000 13B Blueberry 0 . 500000 1 . 000 1 . 000 Parent. 

Full comment : Parent only 

1302057001 138 8lueberry- babyfood 0 . 500000 1 . 000 1 . 000 Parent 

Full comment: : Par:ent only 

Page 10of 14 
Etoxazole (PC code: I 07091) Dietary Exposure and Risk Assessment 0426228 

1302174000 13B Gooseberry 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1304175000 130 Grape 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1304176000 130 Grape , juice 0 . 500000 1 . 000 1 . 000 Proces 

Fu.11 comment : Processing factor set to one ; parent only 

1304176001 130 Grape , juice- babyfood 0 . 500000 1 . 000 1 . 000 Proces 

Full comment : Processing factor set to one ; parent only 

1304179000 130 Grape , wine and sherry 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1304195000 130 Kiwifruit , fuzzy 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1307130000 13G Cranberry 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1307130001 13G Cranberry- babyfood 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1307131000 13G Cranberry, dried 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1307132000 13G Cranberry, juice 0 . 500000 1 . 100 1 . 000 Pa r ent 

Full comment : Parent only 

1307132001 13G Cranberry, jui ce-babyfood 0 . 500000 1 . 100 1 . 000 Parent 

Full comment : Parent only 

1307359000 13G Strawberry 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1307359001 13G Strawberry- babyfood 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1307360000 13G Strawberry, juice 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only; Default processing factor . 

1307360001 13G Strawberry, juice-babyfood 0 . 500000 1 . 000 1 . 000 Parent 

Full comment : Parent only; Default processing factor . 

1400003000 14 Almond 0 . 010000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

1400003001 14 Almond-babyfood 

Full comment : Parent only 

1400004000 14 Almond , oil 

Full comment : Parent only 

1400004001 14 Almond , oil- babyfood 

Full comment : Parent only 

1400059000 14 Brazil nut 

Full comment : Parent only 

1400068000 14 Butternut 

Full comment : Parent only 

1400081000 14 Cashew 

Full comment : Parent only 

1400092000 14 Chestnut 

Full comment : Parent only 

1400155000 14 Hazelnut 

Full comment : Parent only 

1400156000 14 Hazelnut, oil 

Full comment : Parent only 

1400185000 14 Hickory nut 

Full comment : Parent only 

1400213000 14 Macadamia nut 

Full comment : Parent only 

1400269000 14 Pecan 

Full comment : Parent only 

1400282000 14 Pistachio 

Full comment : Parent only 

1400391000 14 Walnut 

Full comment : Parent only 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

0 . 010000 1 . 000 1 . 000 Parent 

1500120000 15 Corn, field, flour 0 . 010000 1 . 000 1 . 000 New, P 

Ful l comment : New, Parent only; Default processing factor = 1 . 

1500120001 15 Corn , field , flour- babyfood 0 . 010000 1 . 000 1 . 000 New, P 

Page 11 of 14 
Etoxazole (PC code: I 07091) Dietary Exposure and Risk Assessmenl 0 426228 

Full comment : New, Parent only; Default processing factor = 1 . 

1500121000 15 Corn, field, meal 0 . 010000 1 . 000 1 . 000 New, P 

Full comment : New, Parent only; Default processing factor = 1 . 

1500121001 15 Corn, field , meal-babyfood 0 . 010000 1 . 000 1 . 000 New, P 

Full comment : New, Parent only; Default processing factor = l . 

1500122000 15 Corn, field , bran 0 . 010000 l . 000 1 . 000 New, P 

Full comment : New, Parent only; Default processing factor = 1 . 

1500123000 15 Corn, field, starch 0 . 010000 l . 000 1 . 000 New, P 

Full comment : New, Parent only; Default processing factor = 1 . 

1500123001 15 Corn, field , starch- babyfood 0 . 010000 1 . 000 1 . 000 New, P 

Full comment : New, Parent only; Default processing factor= 1 . 

1500124000 15 Corn, field , syrup 0 . 010000 1 . 000 1 . 000 New, P 

Full comment : New, Parent only; Default processing factor = 1 . 

1500124001 15 Corn , field , syrup- babyfood 0 . 010000 1 . 000 1 . 000 New, P 

Full comment : New , Parent only; Default processing factor = 1 . 

1500125000 15 Corn , field , oil 0 . 030000 1 . 000 1 . 000 New, P 

Full comment : New, Par ent only; Default processing factor = 1 . 

1500125001 15 Corn, field , oil-babyfood 0 . 030000 1 . 000 1 . 000 New, P 

Full comment : New, Paren t only; Default processing factor= 1 . 

1500126000 15 Corn, pop 0 . 010000 1 . 000 1 . 000 New, P 

Full comment : New, Parent only 

2003128000 20C Cottonseed, oil 0 . 050000 1 . 000 1 . 000 Parent 

Full comment : Parent only; Default processing factor . 

2003129001 20C Cottonseed, oil-babyfood 0 . 050000 1 . 000 1 . 000 Parent 

Full comment : Parent only; Default processing factor . 

3100046000 31 Beef, meat byproducts 0 . 020000 1 . 000 1 . 000 transl 

Full comment : translated from fat 

3100046001 31 Beef, meat byproducts- babyfood 0 . 020000 1 . 000 1 . 000 transl 

Full comment : translated from fat 

3100047000 31 Beef, fat 0 . 020000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

3100047001 31 Beef, fat-babyfood 0 . 020000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

3100048000 31 Beef, kidney 0 . 006700 1 . 000 1 . 000 Parent 

Full comment : Parent and Metabolite 1 

3100049000 31 Beef, liver 0 . 010000 1 . 000 1 . 000 Parent 

Full comment : Parent and Metabolite 1 

3100049001 31 Beef, liver- babyfood 0 . 010000 1 . 000 1 . 000 Parent 

Full comment : Parent and 

Metabolite 1 

3200170000 32 Goat , meat b yproducts 0 . 020000 1 . 000 1 . 000 tra nsl 

Full comment : translated from fat 

3200171000 32 Goat , fat 0 . 020000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

3200172000 32 Goat , kidney 0 . 006700 1 . 000 1 . 000 Parent 

Full comment : Parent a nd Metabolite 1 

3200173000 32 Goat, liver 0 . 010000 1 . 000 1 . 000 Parent 

Full comment : Parent and Metabolite 1 

3500340000 35 Sheep, meat byproducts 0 . 020000 1 . 000 1 . 000 transl 

Full comment : translated from fat 

3500341000 35 Sheep, fat 0 . 020000 1.000 1.000 Parent 

Full comment : Parent only 

3500341001 35 Sheep, fat- babyfood 0 . 020000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

3500342000 35 Sheep, kidney 0 . 006700 1 . 000 1 . 000 Parent 

Full comment : Parent and Metabolite 1 

3500343000 35 Sheep, liver 0 . 010000 1 . 000 1 . 000 Parent 

Full comment : Parent and Metabolite 1 

3600222000 36 Milk, fat 0 . 010000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

3600222001 36 Milk, fat- baby food/infant formu 0 . 010000 1 . 000 1 . 000 Parent 

Full comment : Parent only 

9000157000 80 Fish-freshwater f i nfish 0 . 005000 1 . 000 1 . 000 

Page 12of 14 
Etoxazole (PC code: I 07091) Dietary Exposure and Risk Assessment 

8000158000 

8000159000 

8000160000 

8000161000 

8000162000 

8601000000 

80 Fish-freshwater finfish , farm ra 

80 Fish-saltwater finfish , tuna 

80 Fish-saltwater finfish , other 

80 Fish-shel l fish , crustacean 

80 Fish-shellfish, mo llusc 

86A Water, direct, all sources 

Full comment : EDWC = 4 . 761 ppb 

8602000000 868 Water , indirect, all sources 

Full comment : EDWC = 4 . 761 ppb 

9500020000 O Avocado 

Full comment : Parent only 

9500074000 O Canistel 

Full commen t : Parent only 

9500177000 0 Grape , leaves 

Full comment : Parent only 

9500178000 O Grape , raisin 

0 . 005000 

0 . 005000 

0 . 005000 

0 . 005000 

0 . 005000 

0 . 004761 

0 . 004761 

0 . 200000 

0 . 200000 

0 . 500000 

1 . 500000 

1 . 000 

1. 000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1. 000 

1. 000 

1 . 000 

1. 000 

1. 000 

Full comment : Processing faccor set co one ; parent o n l y 

9500188000 0 Hop 7 . 000000 1 . 000 

Full comment : Parent only 

9500215000 O Mango 0 . 200000 1. 000 

Full comment : Parent only 

9500215001 0 Mango-babyfood 0 . 200000 1. 000 

Ful l comment : Parent only 

9500216000 0 Mango , dried 0 . 200000 1. 000 

Full comment : Parent only 

9500217000 0 Mango , juice 0 . 200000 1. 000 

Full comment : Parent on ly 

9500217001 O Mango , juice-babyfood 0 . 200000 1. 000 

Full comment : Parent only 

9500245000 0 Papaya 0 . 200000 1. 000 

Full comment : Parent only 

9500245001 0 Papaya- babyfood 0 . 200000 1. 000 

Full comment : Parent only 

9500246000 0 Papaya , dried 0 . 200000 1 . 800 

Full comment : Parent only 

9500247000 0 Papaya , juice 0 . 200000 1 . 500 

Full comment : Parent only 

9500275000 0 Peppermint 10 . 000000 1. 000 

Full comment : Parent only 

9500276000 0 Peppermint, oil 20 . 000000 1. 000 

Full comment : Pa r ent o n ly 

9500333000 O Sapote , Marney 0 . 200000 1. 000 

Full comment : Parent only 

9500352000 0 Spearmin t 10 . 000000 1. 000 

Ful l comment : Parent only 

9500353000 0 Spearmint, oil 20 . 000000 1. 000 

Full comment : Parent only 

9500372000 O Tea , dried 15 . 000000 1. 000 

Full comment : Parent only - Import 

9500373000 0 Tea , i nstan t 15 . 000000 1 . 000 

Full comment : Parent only - Import 

Page 13of1 4 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1. 000 

1. 000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1. 000 

1. 000 

1. 000 

1. 000 

1. 000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1. 000 

1. 000 

1 . 000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1. 000 

0426228 

EDWC 

EDWC 

Parent 

Parent 

Pa rent 

Proces 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 

Pa rent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 

Parent 
Etoxazole (PC code: I 07091) Dietarv Exposure and Risk Assessment D426228 

Attachment 2. Chronic DEEM-FCfDTM Analysis. 

us EPA Ver . 3 . 16 , 03 - 08-d 

DEEM-FCID Chronic a nalysis for ETOXAZOLE NHANES 2003-2008 2-day 

Residue file name : C: \Users\tbloem\Documents\work\etoxazole\citrus import\107091C. R08 

Adjustment factor U2 NOT used . 

Analysis Date 05-07-2015/09 : 28 : 12 Residue file dated: 05-07-2015/09 : 27 : 51 

Reference dose (RfD, Chronic) = . 046 mg/kg bw/day 

COMMENT 1 : Section 3 request for use on field corn and pop corn . 

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 

Ch ildren 7-12 

Male 13-19 

Female 13- 19/NP 

Male 20+ 

Female 20+/NP 

Senioi:-s 55+ 

All Infants 

Female 13-50 

Children 1- 2 

Children 3 - 5 

Childr en 6-12 

Youth 13-19 

Adults 20-49 

Adults 50-99 

Female 13-49 

Total exposure by population subgroup 

Total Exposure 

mg/ kg 

body wt/day 

0 . 001650 

0 . 001789 

0 . 001642 

0 . 001516 

0 . 001704 

0 . 002071 

0 . 004355 

0 . 001404 

0 . 005235 

0 . 001983 

0 . 001102 

0 . 001112 

0 . 001224 

0 . 0012 44 

0 . 001293 

0 . 003650 

0 . 001173 

0 . 006865 

0 . 004616 

0 . 002216 

0 . 001107 

0 . 001209 

0 . 001278 

0 . 001171 

Page 14 of 14 

Percent of 

Rfd 

3 . 6% 

3 . 9% 

3 . 6% 

3 . 3% 

3 . 7% 

t] . 5% 

9 . 5% 

3 . H 

11. 4% 

4 . 3% 

2 . 4% 

2 . 4% 

2 . 7% 

2 . 7% 

2 . 8% 

7 . 9% 

2 . 5% 

14 . 9% 

10 . 0% 

4 . 8% 

2 . 4% 

2 . 6% 

2 . 8% 

2 . 5%