### Date: Subject:

Rev iewerff o: Through: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

29

- September-2015 OFFI CE OF CHEMI C AL SAFE TY AND POLL U TION PRE VENTION



### Etoxazo le. Dietary Risk Assessment in Support of the Proposed Tolerances in/on Imported Oranges and Orange Oil. PC Code: I07091 DP Barcode: 0426228 Dec is io n No.: 4 93877 Registration Nos.: not applicable Petition No.: 4 E 8304 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 Divi sio n (RAB 1/HED; 7509P) P. Yvonne Barnes, Biolog i st ,

# RAB6/HED**~~~** Thruston Morton, Acting RAB I Branch Chief, RAB l/HED Dietary Exposure Scienc e Advisory Council (DESAC) George F . Kramer, Ph.D., Senior

## Chemis**~~** • RABl/HED (7509P) Executive Summary In support ofthe proposed establishment of import tolerances inion oranges and orange oil, a chronic dietary risk assessment was conducted using the Dietary Exposure Evaluation Model

- Food Consumpt ion 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 s ingle dose were no t identified and etoxazole i s 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 etoxazo le ha s a high potential to bioaccumulate , residue estimates for fish/shellfish were included. The resulting chronic exposure estimates do no t exceed HED's level of concern**15%** 

### chronic population-adjusted dose (cPAD); children 1- 2 years old were the most highly exposed subpopulation ) . Page I of 14

### Etoxazo l e ( PC code: I07091) 

### Dietary Exposure and 

### R isk Assessmenr 

### 0426228 I. 

### Intro d ucti o n Di etary risk assess ment incorpo rate s both ex pos ure and to x icity o f a g iven pes ti c ide . For ac u te a nd c hron ic asses s m ent s, th e ri s k is expre s sed as a percenta ge of a maximum acceptabl e do se (i. e . , th e do se whic h HE D c o nc lud ed w ill res ult in no unreaso nab l e adv erse hea lth e ff ects). Th i s do se is referre d to as the PAD. T he PAD is equi va lent to the po int ofdeparture ( POD , N O AEL , LO AEL. e.g.) di vi d ed by th e r eq ui re d uncertai nty or safet y facto rs . For ac u te and n o n- c ancer c hro ni c exposures, HED is co ncerned w hen estimated d ietary ris k exceeds I00% o f the PAD . References wh ich di scu ss the ac ute and chronic ri sk assess ments in more d etai l are ava il ab le on the E PA/ p esti c id es web s ite: ·'Availab le Info rmati o n o n Assess ing Exp os ure fro m Pes ti c ides , A User's Guide," 2 1

-Jun- 2 000, we b link: http :l/w wv v'. regu lation s. go v/# !d ocum entD etail ;D =EP A

- HQ-OPP

2007-0780

- 00 0 1 ; o r see S OP 9 9. 6 (20

-Aug -1 999) . T he mo s t rece nt etoxazo le d ietary expo s ure ana ly s i s can be found in 0 3 8 5 94 1 

### (J. T y l er, 29-Aug- 2 0 1 1) . H . Re s idu e Inform a tion R esidu es o f Co 11 cem - Pla11t s a11d Livestoc k : 

### B ase d o n the ava il able cotton. eggplant , ora n ge, a pp le. p oul try , and rumi nant m e tab o li sm stud ies , the co nfin ed ro tational cro p studies, and t h e e n viro nmenta l fa te data, HED c oncludes tha t the res idues of concern fo r to lerance enforc e me nt a nd ri s k assess m ent are as d efined in Table I. T a bl e I: S umm a r y o f M e tab o lites and De !!ra d atc s of Co n ce rn for Ri sk A ssess m e nt a nd T o leran ce Enforce me nt . Matrix R esidues ofConcern Ri sk Assessment Tolerance Enforcement !Primary crops - except cotton ain byproducts and almond hulP etoxazo l e lorimarv crops - cot t on 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 mu scle / fail etoxazolc ruminant liver /kidne v2 etoxazo le an d metabolite I water3 ParenL R- 8. and R-13 

# -- ro ta tio na l**ops~** no decis i on no deci s ion 1 0 283737, J . T y ler , 3 1-J ul -2003: 030362 8 . J. Ty l e r. 30 -M ar - 2005: 0307 17 8. J . Ty le r. 6-A p r-2005: 0289666 . J . T y l er. 1 7-.l un-2003 2 0283737. J. T y ler. 3 l -J ul -2003: 0 289666. J . Ty l er, 17-Ju n-2003; 0289666. J . Ty l er, 17 -Ju n-2003 J 0289666 . J . Ty ler. I7-Jun

- 2003

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

### R e g is t e red and Pr o

p os ed To le ran ces: 

### Pe rm anen t to lerances have been es tablis hed fo r r es idues of etoxazole inio n severa l pla n t and li ves t ock co mmodities (40CFR§ 1 80.593). The current peti tion i s fo r the es tabli s hme nt of imp ort to lera n ces fo r res idues of etoxazo l e i n/on orange and o ran ge o il. B ase d o n th e s ubmitted data, HED co nclud ed that the fo ll owi ng to lerance s fo r res idues of etoxazo le ar e appropriate (D4 24 37 5. T. B loe m, 2 9

- Sep- 2 0 1 5) : o range - 0 . 10 ppm and o range oi l

- 1. 0 ppm . R esidues Ass umpti o 11 s In co rp o rated int o til e Dietar y A ssessm e 11t : 

### T he c hro ni c assess me nt ass u me d tolera nce level residues or to lerance level res idues adju sted fo r the res idues of co ncern fo r ri s k assess me nt and I00% crop tre ated . Since the available p rocess in g data ind ic ate th a t residues of etoxazo le do n ot co ncentrate in app le j ui ce, cotto nseed o il , or o ran ge jui ce (0 283737. J. 

### T y ler , 3 1-Jul- 2003; 0424375, T. Bl oem, 29

- Sep-20 1 5) , the D EEM (ve r . 7.8 1) d efault process ing fac to rs fo r these co mmodit ies were set t o I (tan gerine j ui ce process ing fac tor was a lso P age 2of 14Etoxazole ( P C code: I 07091) Dietary Exposu re and Risk Assessment 

### 0426228 

### set to I based on the orangeju ic e data). 

### An adequate grape processing study is not availab le. Howeve r , based on the theoretical concentration factors for grape juice and raisins (OCSPP 860.1520) and the highest-average field trial (HAFT) for g r apes, HED previously determined that a 1.5 ppm grape rais in tolerance was required and a grape juice to lerance was unnecessary (D303628, J. Ty ler, 30-Mar-2005). Based on this decision and since to lerance 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 commoditi es, 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 to lerance was establ i shed for the processed commodity . 

### Fislz/Shelljish: Tolerances for residues of etoxazole in/on fish/shel lfish have not been estab lished . The US DA 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 potentia l to bioaccumulate (0311941, J . Melendez, 31-May-2005), HED included residues in fish/shellfish at the LOD for t he PDP data (0 .00 5 ppm). Tab le2: Estab l is h e d a nd HED-Recommended To lera n ces and Res i due Va lu es for Ri sk Assess ment P urp oses. Recommended/ Residue Values for Commodity Estab lishcd Chronic Dietary DEEM (ver. 7.8 1) Defau lt Processing Factors To l erance Expos ure (ppm)I Assessment (ppm) 1 Oran g e s 0. 10 0. 1 0 The orange juice processing factor was reduced to I based on empirica l data (0 4 24375 , T. B loem , 29-Sep-20 I 5). Oran g e oil 1. 0 1. 0 Separate tolerance estab li shed therefore th e processing factor reduced to I. Avocado 0.20 0.20 

# -- Berry. low growing, subgro up 13

-07G 0.50 0.50 The default processing fac tor for cranberry juice (I. lx) was ret ained. Caneberry subgroup 13-07A 1.5 1.5 

# -- Canistel 0.20 0.20 

# -- An adequate field corn processing study is avai lab l e a nd Corn , field , grain 0.01 0.01 indicates that residues do not concentrate in com starch (trans l ated to com grain sugar/hfcs) , grits. flour or meal (0385940, J. Ty l er, 23-Scp-2011 ); this same study indic ated Corn. field , refined oil 0.03 O.Q3 that residues do concentrate in oil which led to the refined oil t olerance. Corn, pop. grain 0.0 1 0.01 

## -- C ot1on , undelinted seed 0 . 05 0.05 Available processing data indicate that residues do not concentrate in cononsecd oil (0283737 , J. Ty ler, 31-Jul-2003). Available processing data indicate that residues do not concentrate in apple juice (0283737. J . Tyler, 3 l -Jul-2003). Fruit, pome , g roup 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 3of14Etoxazole (PC code: I 07091) Dietary Exposure and Ri sk Assessment 

### 0 426228 Tab lc2: Establi s hed and HED

- Rec ommended T oleran ces and Res idue Va lu es for Ri sk Assess ment Purp oses. Recommended! Re s idue Values for Commodity Estab lished Chronic Dietary DEEM (vcr. 7.8 1) Default Proce ss ing Factors Tolerance Expos ure

(ppm)I As sess ment (ppm) 1 A grape process in g s tudy has not been s ubmill cd: ho w eve r. th e available information indicate s that the subgroup toleranc e is Fruit. s mall vine climbing. except 0.50 0.50 adequate to cover res idue s in grape juice ( 033903 9. J . Ty l er. fuzzy kiwifruit. s ubg roup 13-07F I 7-Jul-2009) . Therefore th e default grape juice processi ng factor was reduced to I . A separate grape rai s in tolerance is established (sec below). The default process in g factor were retained for dried apricot r:ruit, s tone, group 12. excepl plum 1.0 1. 0 (6.0x). cherry jui ce ( I .5x). and dried peaches (7.0x). eparatc tolerances for plum and dried prune are established (sec below). Grape. rai s in 1.5 1. 5 Default pr oce ss in g factor reduced lo I because a s1: parate tolerance is e stabli shed . I lop. dried cones 7.0 7.0 

## - Mango 0.20 0.20 

# -- Mel on subgroup 9A 0.20 0.20 

# - Milk. fat 0.01 0.0 1 

# -- Nut. tn:e, group 14 0.01 0 . 01 

## - Papaya 0.20 0.20 The default dried papaya ( I .8x) and papaya juice (I .5 x) processing factors were ret ai ned . Pepper /eggplant s ub group 8- 1 OB 0.20 0 .20 

# -- Peppennint. oil 20 20 

# -- Peppermint. tops 10 10 

## - Pi s tachio 0.01 0.0 1 

# -- Plum 0. 15 0. 15 

## -- Since a separate toleranc e is e s tabli shed. th e default proce ss ing Plum . prune. dried 0.30 0.30 factor for dried prunt: was reduced to 1. The default plum /prune juice ( l .4x) process ing factor was reiain ed. Sapodilla 0 .20 0.20 

# -- Sapote, black 0 .20 0.20 

# -- Sapo le. mamey 0.20 0.20 

# -- SpearminL oil 20 20 

### - SpeanninL !Ops 10 10 

# - - Squas h/c ucumber subgro up 9 B 0.02 0.02 -- Star apple 0.20 0.20 

## -- !rhe default tangerine juice process ing factor was redu ced to I Tangerine ' 0. 1 0 0 . 10 based on the orange pr ocess ing study which indicated th at residues do not concentrate in ju i ce .. Tea, dried* 15 15 

# -- A tomato process in g s tudy has not been s ubmined: th e defau lt Tomato 0.20 0.20 tomato dried ( 14 .3x) .juice ( l.Sx ) . puree (3.3x) . and paste (5 .4x ) processin g factors were r etai ned .



### Page 4of 14Etoxazole (PC code: 107091) Dietary Exposure and Risk Assessment 0426228 Table2: Estab li s h ed and H E D-Recommended Tolerances and Res idue Va lu es for Risk Assess ment Purposes . Recommended/ Residue Values for Commodity Estab li shed Chro nic Dietary DEEM (vcr. 7 .81 ) Default Processing Factors To l erance 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 s heep )3 

### NA 0.0067 

# -- Fish / shellfish 5



## -- 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, th e residue of concern for tolerance enforce ment is parent only and the re sidue of concern for risk asses s ment is parent and Metabolite 1. 2 The calculated residue l evel of e toxazo le and Metabolite I in ruminant liver was less th an the HED-recommended tol eranc es of0.01 ppm: therefore tolerance-level residues were assumed (038594 1, 

### J. Tyler, 23-Sep-2011 ). 3 The results of the submitted livestock feeding s tudy indicate that tolerances are not needed for ruminant kidney (40 CFR § J 80.6(a)(3)): however, as quantifiable residues of Metaboli te I (a residue of concern for risk assessment purposes) were me asured in kidney in the feeding study, kidney (parent and Me tabdite I) was included in the ri sk assessmen t ( 0385941 , J. Tyler, 23-Scp-2011) 4 A lthou gh a tolerance in /on ruminant meat byproducts has not been es t ab li shed, HED determined that the fat residue should be applied 10 meat byproducts. 5 Tolerances for residues of ctoxazo le in /on fish/ s hellfi sh 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 (LO O = 0.001-0.005 ppm). Based on EFED ' s conclusion that etoxazo l e 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 app li cation rate of 0.36 l b ai /ac re. EFED ca l cu lated 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 DW Cs for Etoxazo le a n d Metab o li tes for C hronic Ana lys is Source Etoxazo l e (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 Cons ump tion 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., app les, 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: I07091) 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 follow ing 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 s ummed 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. Toxico logical Informati on Etoxazo le was pre sented 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 s ummary of the toxicological doses and endpoints selected for dietary exposure assessment. Table 4: Summa r y of Toxico log ical Doses and Endpoints fo r Etoxazo le for Use in Human-Hea lt h 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 attributab l e to a single dose were not identifi ed in the database including the including infants and children) developmental toxicity studies. Acute Dietary (Females 13-49 A dose and endpoint attributable to a s ingle dose were not identified in the database includin g the years of age) developmental toxicity studies . Chronic 

### Ora l Tox icity Study- Dog UFA= I OX LOAEL = 23.5 mg/kg/da y 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 ofdepartur e (POD) = A data p omt or an estimated pomt that 1s derived from observed d OS(} re sp on

se data and u se d t o mark the begmnmg ofextrapolation to dctennine risk associated with lower environmental l y relevant human exposures. NOA EL = no-observed adverse·cffcct l evel. LOAEL = lowe st-o b serve d adverse-effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in se n sitivit y among members of the human population**intra~pecies) .**  FQPA SF= FQPA Safety Factor. PAD= populati onadjusted d ose (a = acute. c = chronic) . Rm = reference dose .



### Page 6of14

### Etoxazole CPC code: 107091) Dietary Exposure and Risk Assessment 

### 0426228 

## VI. Results/Discussion The chro nic dietary analysis resulted in expos ure 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. Tab le 5 is a summary of the results of the chronic analysis.

Table 5: Summary of C h ro ni c Dietary (food and water) Expos ure a nd Risk Est im ates. Population Subgro up cPAD (mg/kg/day) C hronic Ex po sure (mg/kg/day) %c PAD general U.S. Population 0.001650 4 a ll Infants (< I year old) 0.003650 8 ch ildre n J-2 yea rs o ld 0.006865 15 child ren 3-5 years old 0.004616 10 children 6 -1 2 years o l d 0 . 046 0.0022 16 5 youth 13 -19 years old 0.00 11 07 2 adults 20 -49 years old 0.00 1 209 3 adults 50-99 years old 0.001278 3 fema l es 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 residu es 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. Co nclu sions The chronic dietary analysis resulted in exposure estimates of S l 5% c PAD (children 1-2 years old were the most highly exposed population s ub group); therefore, chronic exposure to etoxazole does not exceed HED's level of concern. Thi s assessment is conservative in that it assumed tolerance level res idues and 100% crop treated. Attachment 1: DEEM-FCIDTM chronic resid u e fi l e . Attachme nt 2 : DEEM-FCIDTM chronic exposure estimates.



### Page 7of14E t oxazole (PC code : I 07091) Dietarv Exposure and Ri sk Assessment 

### Attac hment 1. Re s idue File for Chron ic DE EM -FCJDTM Analys is. Filename : C : \Users\tbloem\Documents\work\etoxazole\cit r 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 

### 0 42622 8

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 T o ma to-babyfood Full comment : Parent only 080 1376000 SA Tomato , paste OS01376001 SA Tomato , paste-babyfood 0801377000 SA Tomato , puree 080137700 1 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 : Pare n t o n 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 090202 1000 9B Balsam pear Full comment : Pare n t only 09020SBOOO 9B Chayote , fruit Full comment : Pare n t o n ly 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 

### P age 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 P

arent Parent Parent Parent Parent

### Etoxazole (PC code: 107091) 

### Di etary E xposure and Risk Assessment 0426 228 Full 

### comment : Parent only 0902356001 9B Squash , summer - babyfood 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 , ju i 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 Pare n 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

- babyfood 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 - babyfood 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 1 100210000 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

- babyfood 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 Expo sure and Risk Assessment 

### 0426 22 8 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

- babyfood 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 : Pare n t only ; Default processing factor . 1202261001 128 Peach , dried-babyfood 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-babyfood 0 . 150000 1. 

### 000 1. 

### 000 Parent Full comment : Pare n t o n ly 1203286000 12C Plum , prune , fres h 0 . 150000 1. 

### 000 1. 

### 000 Parent Full comment : Parent only 1203286001 12C Plum , prune , fresh

- babyfood 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 n t on l 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

- babyfood 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 : Pare n t o n ly 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

## P age 10of 14

### Etoxazole (PC code : I07091) 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.1 1 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 Ful l 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 , ju i ce-babyfood 0 . 500000 1 . 100 1 . 000 Parent Full comment : Parent only 1307359000 13G Strawberry 0 . 500000 1 . 000 1 . 000 Parent Ful l comment : Parent only 1307359001 13G Strawberry

- babyfood 0 . 500000 1 . 000 1 . 000 Parent Full comment : Pare n t 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 140000300 1 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 Ful l 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 Fu l 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 14Etoxazole (PC 

### code: I07091) Dietary Exposur e and Ri sk Assessmen l 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 N e w, P Full comment : N e w, Pa r en t only ; Default processing factor = 1 . 1500125001 15 Corn , field , oil- b abyfoo d 0 . 030000 1 . 000 1 . 000 Ne w, P Full comment : N ew , Pare n 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 n sl Full comment : translate d fro m fat 3200171000 32 Goat , fat 0 . 020000 1 . 000 1 . 000 Parent Full comment : Pare n t only 3200172000 32 Goat , kidney 0 . 006700 1 . 000 1 . 000 Parent Full comment : Pare nt a n d 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: I07091) D ietary Exposure and Ri s k Assessment 8000158000 8000159000 8000160000 8000161000 8000 162000 8601000000 80 Fish-freshwater finfish , farm ra 80 Fish-saltwat er finfish , tuna 80 Fish-saltwater finfish , other 80 Fish-shel l fish , crustacean 80 Fish-shellfish , mo ll usc 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 comme n 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 . 00476 1 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 o n ly 9500217001 O Mango , juice-babyfood 0 . 200000 1. 000 Full comment : Parent only 9500245000 0 Papaya 0 . 200000 1. 000 Full comme nt : 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 Spearmi n t 10 . 000000 1. 000 Ful l comment : Parent only 9500353000 0 Spear m

int , oi l 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 nsta n t 15 . 000000 1 . 000 Full comment : Parent only

- Import



### Page 1 3of1 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 EDW C Parent Parent Pa rent Proces Parent Parent Pare nt Parent Parent Parent Parent Parent Parent Pa rent Parent Parent Parent Paren t Parent Parent Parent

### Eto xazo le ( PC code: I07091) Dietarv Exposure and Ri sk Assessment D426228 

### Attachment 2. Chronic D EEM -FCfDTM Analysis. 

## us EPA Ver . 3 . 16 , 03

- 08-d DEEM-FCID Chronic a n alysis for ETOXAZOLE NHANES 2003-2008 2-day Residue file n ame : C : \Users\tbloem\Documents\work\e toxaz ole\citrus import\107091C . R08 Adjus tme nt factor 

### U 2 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 .

Popul ation

Subgroup Total US Population Hispanic Non

- Hisp

- White Non

- Hisp

- Black Non

- Hisp

- Other Nursing Infants Non-Nursing Infants Female 13+ PREG Childre n 1-6 C

h il dren 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 Child r 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%