Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **1** of **41 UNITED STA** 

**TES ENVIRONMENTA L PROTECTION A** **GENCY WA** **SHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND**  **POLLUTION PREVENTION**



### MEMORANDUM DATE: May

1 , 201 3 SUBJECT: In doxacarb Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action on Dry B eans, S ucculent B eans, S mall F ruit V ine C limbing S ubgroup (except kiwifruit) 13

- 07F and L ow Grow ing B erry S ubgroup (except strawberry ) 13

- 07H
. **PC Code: 067710**  **DP Barcode: D**  **408983 Decision No.:**  **464583 Registration No.**  **: 352**  **- 597**  **Petition No.: 2E8029**  **Regulatory Action: S**  **ection 3**  **Risk Assessment Type: Single Chemical /Aggregate**  **Case No.: NA**  **T XR No**  **.: NA**  **CAS No.: 173584**  **- 44**  **- 6**  **MRID No.: NA**  **40 CFR: 180.**  **564**

REVIEWER: Id eliz Negrón

- Encarnación, Ph.D., Chemist

Risk Assessment Branch V Health Effects Division (7509P) THROUGH: Doug las Dotson, Ph.D., Chemist

Kristin Rury , Chemist Dietary Expo sure Science Advisory Council (DESAC) TO: Danette Drew , Senior C hemist

Risk Assessment Branch V Health Effects Division (7509P) and Barbara Madden, Team Leader Risk Integration Minor Use, and Emergency Response Branch Registration Division ( 7505P)Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **2** of **41 Executive Summary**  A cute and chronic dietary risk assessments for i ndoxacarb were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM

- FCID) Version 3.16, which uses food consumption data fro m the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey , What We Eat in America, (NHANES/WWEIA) from 2003 to 2008. The last dietary risk assessment for indoxacarb was conducted on 18

- Feb

- 2009 (S. Tadayon ; D 360559 ) and the chronic was further refined on 13

- May
2009 (S. Tadayon; D364939)

. The acute and chronic dietary risk assessment has been updated to support the proposed S ection 3 registrations on dry beans, s ucculent beans , S ma ll fruit vine climbing subgroup (except kiwifr uit) 13

- 07F and L ow growing berry subgroup (except strawberry ) 13

- 07H
. This memorandum was reviewed by two peer reviewers of the DESAC per SOP 2012.1. Refined acute probabilistic and chronic dietary exposure assessments were conducted for existing and pr oposed new food uses of indoxacarb and drinking water . A cancer dietary exposure assessment was not conducted for indoxacarb, because indoxacarb has been classified as “not likely to be carcinogenic.” Anticipated residues (ARs) for all registered and pro posed food commodities were based on field trial data (FTD) or tolerance level residues

. When necessary , ARs for all current uses were further refined using percent crop treated (%CT) data (A. Halvorson, 05

- Apr

- 2007 , D 338731 ) following the guidance provid ed in HED Standard Operating Procedure (SOP) 99.6 ( Classification of Food Forms with Respect to level of Blending ; 20

- Aug - 1999). Available processing data for indoxacarb were used to refine ARs for apples/pears (juice), potato (dry , chips), cotton (oil), tomato (paste and puree), peanut (oil), soy bean (oil), grapes (raisin and juice), prunes (dried), and mint (oil), and other commodities where translation was applicable. DEEM
- FCID  (ver. 7.81) default processing factors (PFs) were assumed for all other processed commodities for which these have been established. EDWCs were provided by EFED ( C. Koper, D402100, 06

- Nov
- 2012 ) and incorporated directly into the DEEM

- FCID  analyses. Both the acute and chronic analyses were conducted using estimated surface wat er residues generated using the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS). Estimated acute dietary

exposure to indoxacarb from food and drinking water is below HED’s level of concern (i.e. < 100% aPAD) for all population subgroups. Combined dietary exposure from food and drinking water at the 99.9 th 

### percentile of exposure is estimated to be 0.0 32 762 mg/kg/day

for the overall U.S. population equivalent to 27 % of the aPAD. The population subgroup with the highest estimated acut e dietary exposure to indoxacarb is all infants (< 1 year old) , with an estimated exposure at the 99.9 th 

### percentile of 0.0 58 294 mg/kg/day , equivalent to 49 % of the aPAD. Estimated chronic dietary exposure to indoxacarb from food and drinking water is be low HED’s level of concern (i.e. < 100% cPAD) . Combined dietary exposure from food and drinking water isIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **3** of **41** estimated at 0.00 1133 mg/kg/day for the general U.S. population ( 5.7 % of the chronic population

adjusted dose (cPAD ) and 0.0 02381 mg/kg/day ( 1 2 % of th e cPAD) for children, 1 to 2 years old, the population subgroup with the highest estimated chronic dietary exposure to indoxacarb.
**I. Introduction**  Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chron ic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose that 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 e quivalent 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 100% of the PAD. References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available I nformation on Assessing Exposure from Pesticides, A User’s Guide,” 21

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

- PEST/2000/July /Day

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

- Aug

1999).
**II. Residue Information**  In doxacarb is an oxadiazine insecticide used for control of lepidopteran pests on a variety of fruit, vegetable and field crops. Tolerances for the combined residues of indoxacarb + it s R
- enantiomer are published in 40 CFR §180.564. There are currently two end

- use products of indoxacarb with food/feed uses registered to DuPont: a 30% water

- dispersible granular (WDG) formulation (DuPont Avaunt In secticide, EPA Reg. No. 352

- 597) and a 1.25 lb/gal (15%) suspension concentrate (SC) formulation (DuPont Steward® 

### In secticide, EPA Reg. No. 352

- 598). These formulations contain an isomeric mixture of 75% indoxacarb (insecticidally active S

- enantiomer; DPX
- KN128) and 25% of the R

- enantiomer (in secticidally inactive; I

N
- KN127). The percentage of active ingredient (a.i.) listed on each label and the labeled use rates for each crop are based only on the amount of indoxacarb. Residues of Concern: The nature of the residue in plants and livestoc k is adequately understood. Data from the plant and ruminant metabolism studies, as well as toxicological and environmental fate data were presented to the HED Metabolism Assessment Review Committee (MARC) for determination of the residues of concern (S. Levy , 10

- Jul

- 2000; D 263986). In doxacarb and its R

enantiomer were the relevant residues of concern to be established for the tolerance enforcement and risk assessment in plants. MARC has determined that the tolerance expression for milk, ruminant and pou ltry

commodities will include indoxacarb and its R

- enantiomer. The residues of concern for risk assessment in milk will also include the metabolite I N
- MP819 ; and in poultry the metabolites I

N
- JT333, I

N
- JU873, I

N
- KB687, I

N
- KG433, I

N
- KT319, 5

- HO

- IN
- JT333, andIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **4** of **41** Metabolite F will be included as well. Refer to DP# 324855 for the chemical structures of indoxacarb and its metabolites. Tolerances: Permanent tolerances have been established under 40 CFR §180.564(a) for the combined residues of indoxacarb + its R

- enantiomer as follows: Apple, wet pomace (3.0 ppm); Alfalfa, forage (10 ppm); Alfalfa, hay (50 ppm); Beet, garden, roots (0.30 ppm); Beet, garden, tops (6.0 ppm); Bushberry

subgroup 13

- 07B (1.5 ppm); Cattle, fat (1.5 ppm); Cattle, meat (0.05 ppm); Cattle, meat by

products 0.03; Corn, sweet, forage (10 ppm); Corn, sweet, kernel plus cob with husk removed (0.02 ppm); Corn, sweet, stover (15 ppm); Cotton, gin by products (15 ppm); Cotton, undelinted seed (2.0 ppm); Cranberry (0.90 ppm); Fruit, pome, except pear , group 11 (1.0 ppm); Fruit, stone, group 12 (0.90 ppm); Goat, fat (1.5 ppm); Goat, meat (0.05 ppm); Goat, meat by products 0.03; Grain, aspirated fractions (45 ppm); Grape (2.0 ppm); Grape, raisin (5.0 ppm); Hog, fat (1.5 ppm); Hog, meat (0.05 ppm); Hog, m eat by products (0.03 ppm); Horse, fat (1.5 ppm); Horse, meat (0.05 ppm); Horse, meat by products (0.03 ppm); Milk (0.15 ppm); Milk, fat (4.0 ppm); Okra (0.50 ppm); Pea, southern, seed (0.10 ppm); Peanut (0.01 ppm); Peanut, hay (40 ppm); Pear (0.20 ppm); Pear, oriental (0.20 ppm); Peppermint, tops (11 ppm); Sheep, fat (1.5 ppm); Sheep, meat (0.05 ppm); Sheep, meat by products (0.03 ppm); Soy bean, hulls (4.0 ppm); Soy bean, seed (0.80 ppm); Spearmint, tops (11 ppm); Turnip, greens (12 ppm); Vegetable, Brassica, leafy , group 5 (12 ppm); Vegetable, cucurbit, group 9 (0.60 ppm); Vegetable, fruiting, group 8 (0.50 ppm); Vegetable, leafy , except Brassica, group 4 (14 ppm); Vegetable, tuberous and corm, subgroup 1

- C (0.01 ppm)

. DuP ont has proposed tolerances for i n doxacarb on dry beans and succulent beans

. Inaddition, the Interregional Research Project No. 4 (IR
- 4) proposes tolerances for S mall fruit vine climbing subgroup (except kiwifruit) 13

- 07F and L ow growing berry subgroup (except strawberry ) 13

- 07H based on the current tolerances for grapes and cranberry

. The proposed tolerances are summarized below in Table 1 together with HED’s recommendations based on review of the residue data submitted to support these petitions ( I. Negron , D408982, xx - Feb

- 20 13 ). **Tabl e**  **1 . Tolerance Sum**  **ma ry for**  **Indoxacarb .**  **Com mo**  **dity Established/Proposed**  **Tolerance (ppm )**  **HED -**  **Recom me**  **nded Tolerance (ppm** **) Com**  **me nts (**  **correct**

**commodity definition )**  Bean, dry, seed 0.07 0. 2 Pea, southern, seed 0.1 Remove Bean, succulent 0.64 0.9 Bean, fo rage 37 50 Cow pea, forage Cow pea, hay NA 100 Small fruit vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F 2.0 2 Low growing berry, except strawberry, subgroup 13

- 07H 0.9 1 Cranberry 0.90 Remove Grape 2.0 RemoveIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **5** of **41** Residue Data used for th e Acute and Chronic Assessments: Food Commodities (except livestock commodities): Refined acute probabilistic and chronic dietary exposure assessments were conducted for all existing and proposed food uses of indoxacarb and drinking water. ARs for all r egistered and proposed food commodities were based on tolerance level residues or field trial data ( FTD ) . When a commodity had a number of <LOQ residue values, either the highest FTD or tolerance was used for ease of calculation ( i.e. , for apples, the cor rected highest field trial value was used for the “treated” commodity , instead of constructing a RDF with the full distribution of corrected values). ARs for some current uses were further refined using %CT data, following the guidance provided in HED SOP 99.6 ( Classification of Food Forms with Respect to level of Blending ; 20

- Aug - 1999). 100% CT was assumed for the remaining uses. Available processing data were used to refine ARs for apples/pears (juice), potato (dry , chips), cotton (oil), tomato (paste and puree), peanut (oil), soy bean (oil), grapes (raisin and juice), prunes (dried), and mint (oil), and commodities were translated as appropriate. For all other processed commodities, DEEM

- FCID  (ver. 7.81) default PFs were assumed. Acute Assessment :

 F or non - blended and partially blended commodities: Tolerance level residues or the highest residue from the field trial data was used. A lternatively , a residue

- distribution file (RDF) was constructed using the entire distributio n of field trial residue va lues. If further refinement was needed, the tolerance level, highest residue, or RDF was adjusted to incorporate zeros to account for the untreated portion of the crop (untreated portion = 100% minus the estimated maximum %CT). The resulting residue distributions were used probabilistically

in the acute assessment. All PFs were inserted in DEEM

- FCID  under “adjustment factor 1.”  For blended commodities: A point estimate was calculated by using the average or highest field trial residue

. If refinement w as needed, the point estimate was adjusted by the maximum %CT estimate (point estimate = residue level x maximum %CT). All PFs were inserted in DEEM

- FCID  under “adjustment factor 1.” Chronic Assessment :

 For non
- blended, partially blended and blended co mmodities: Tolerance level, highest or average residue was used

. If further refinement was needed, the average %CT was used. All PFs were inserted in DEEM

- FCID  under “adjustment factor 1 ” while the fCT (fraction of crop treated, %CT/100) was inserted under “adjustment factor 2.” Livestock commodities: For poultry , egg and milk, since the residues of concern for risk assessment were different than those in the tolerance expression, the metabolism study , in conjunction with feeding studies was used to c alculate the secondary residues in those tissues (seeIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **6** of **41** detail discussion later in this section). For ruminant and hog tissues, since the tolerance expression was the same as the residues of concern, the tolerance values were used as conservative estimates of the indoxacarb residues. The food residue data used in the acute and chronic dietary assessments are summarized in Table 2
. RDFs used in the acute assessment are included in the attachments to this document.
**Table 2**  **. Data and Residue Estim ates Used**  **in the Acute and Chronic Dietary Analyses Commodity**  **Classifi**

**cation A**  **ve.**

**% CT Max** 

**% CT Source of Data**  **# of FTD**  **# of zeroes in**  **RDF sum** 

**(FTD) mean of** 

**RDF or**  **FTD 1**  **PF Acute**  **Value Chronic** 

**Value** apple juice PB 5 10 highest FTD (DP#: 244253) 1 9 0.74 0.0 74 0.0 1 rdf x PF 0.74 x fCT x PF apples NB 5 10 highest FTD (DP#: 244253) 1 9 0.74 0.0 74 rdf 0.74 x fCT apples, dried B 5 10 highest FTD (DP#: 244253) 1 9 0.74 0.0 74 8 0.074 x PF 0.74 x fCT x PF Apricot PB 100 100 peach FTD (DP#: 325479) 30 0 4.66 0.155 rdf 0.155 Apricot, dried B 100 100 FTD (DP#: 325479) 30 0 4.66 0.155 6 0.155 x PF 0.155 x PF Bean, guar seed B 100 100 Dry Bean Tol / Ave Residue 13 NA 0.01 0.10 0. 01 Bean (the rest) PB 100 100 Succulent Bean Tolerance 9 NA 0.18 0.90 0.18 Beet Garde n Roots NB/PB 100 100 FTD (DP# 351087) 10 0 1.6 4 0.16 rdf 0.16 Beet Garden Tops PB 100 100 FTD (DP# 351087) 10 0 24. 69 2.47 r df 2.47 Subgroup (13B) PB 100 100 FTD (DP# 351087) 26 0 14.8 0.57 rdf 0.57 Broccoli NB 50 7 0 FTD (DP#: 244253) 20 8 12.95 0. 4625 rdf 0. 648 x fCT Cabbage (no wrapper) NB 25 3 5 FTD (DP#: 244253) 24 40 1.27 0.0 205 rdf 0.0 577 x fCT Cantaloupe NB 100 100 FTD (DP#: 325479) 22 0 2.236 0.1016 rdf 0.1016 Cauliflower NB 50 70 broccoli FTD 20 8 12.95 0. 464 rdf 0. 648 x fCT Celery

untrimmed PB 100 5 FTD (DP#: 325479) 12 0 23.2 1.9333 rdf 1.93 Cherry PB 1 2.5 FTD (DP#: 325479) 32 1248 8 0.0063 rdf 0. 25 x fCT Cherry juice PB 1 2.5 FTD (DP#: 325479) 32 1248 8 0.0063 1.5 rdf x PF 0. 25 x fCT x PF Corn, sweet NB 2.5 10 highest FT D (DP#: 244253) 1 9 0.008 0 .0008 rdf 0. 008 x fCT Cottonseed oil B 100 100 highest FTD (DP#: 244253) 1 NA 0.67 0.67 0.04 0.67 x PF 0.67 x PF Cranberry PB 100 100 FTD (DP#: 325479) 12 0 2.591 0.2159 rdf 0.21 60 Cranberry PB 100 100 FTD (DP#: 325479) 12 0 2.591 0.2159 rdf x PF 0.2160 x PF Cucumber NB 100 100 FTD (DP#: 325479) 20 0 0.459 0.0230 rdf 0.023Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **7** of **41 Table**  **2 . Data and Residue Estim**  **ates Used in the Acute and Chronic Dietary Analyses**  **Commodity Classifi** 

**cation A**  **ve.**

**% CT Max** 

**% CT Source of Data**  **# of FTD**  **# of zeroes in**  **RDF sum** 

**(FTD) mean of** 

**RDF or**  **FTD 1**  **PF Acute**  **Value Chronic** 

**Value** Eggs NB 100 100 see text 1 NA 0.119 0.119 0.119 0.119 Group 8, the rest (okra, eggplant, tomatillo) PB 100 100 highest tomato FTD (DP#: 244253) 1 NA 0.27 0.27 0.27 0.27 Grape PB 100 1 FTD (DP#: 290126) 20 0 10.06 0.5030 rdf 0.503 Grape juice/wine PB 100 1 FTD (DP#: 290126) 20 0 10.06 0.5030 0.007 rdf x PF 0.503 x PF Grape leaves PB 100 100 FTD (DP#: 290126) 20 0 10.06 0.5030 rdf 0.503 Gra pe raisins PB 100 1 FTD (DP#: 290126) 20 0 10.06 0.5030 2.7 rdf x PF 0.5030 x PF Group 11, except apples and pears NB 100 100 highest FTD for apples (DP#: 244253) 1 0 0.74 0.7400 rdf 0.74
Le ttuce head, no wrapper NB 1 0 35 18 33 3.97 0.0 778 rdf 0.22 x fCT Le ttuce, leaf NB 1 0 35 DP#: 244253 18 33 108.2 2.12 rdf 6.01 x fCT Milk fat PB 100 1

- 2.5 see text 1 NA 3.28 3.28 2.43 0.026 Milk water PB 100 100 see text 1 NA 0.11 0.11 0 0 Milk, non

- fat solids PB 100 1

- 2.5 see text 1 NA 0.29 0.29 0.495 0.0052 Mint B 100 100 FTD (DP#: 325479) 12 NA 46.44 3.87 3.87 3.87 Mint oil B 100 100 12 NA 46.44 3.87 0.028 3.87 x PF 3.87 x PF Mustard Green PB 100 100 FTD (DP#: 325479) 8 0 47.8 5.975 rdf 5.975 Nectarine PB 100 100 Peach FTD (DP#: 325479) 30 0 4.66 0 .1553 rdf 0.1553 Peach NB 2.5 2.5 FTD (DP#: 325479) 30 1170 4.66 0.0039 rdf 0. 155 x fCT Peach Dried B 2.5 2.5 FTD (DP#: 325479) 30 NA 4.66 0.0039 4 0.0039 x PF 0.155 x fCT Peanut B 2.5 10 highest FTD (DP#: 244253) 1 NA 0.003 0.0003 0.0003 0.003 x fCT Peanut butter B 2.5 10 highest FTD (DP#: 244253) 1 NA 0.003 0.0003 1.89 0.0003 x PF 0.003 x fCT xPF Peanut oil B 2.5 10 highest FTD (DP#: 244253) 1 NA 0.003 0.0003 1.4 0.0003 x PF 0.003 x fCT x PF Pear NB 1 2.5 highest FTD (DP#: 244253) 1 39 0.08 0. 002 rdf 0. 08 x fCT Pear juice PB 1 2.5 highest FTD (DP#: 244253) 1 39 0.08 0.002 0.01 rdf x PF 0. 08 x fCT x PF Pears, dried B 1 2.5 highest FTD (DP#: 244253) 1 NA 0.08 0.002 6.25 0.002 x PF 0.0 8 x fCT x PF Pepper (bell or non -bell) PB 15 30 highest FT D (DP#: 244253) 30 70 1.005 0.0201 rdf 0.0 67Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **8** of **41 Table**  **2 . Data and Residue Estim**  **ates Used in the Acute and Chronic Dietary Analyses**  **Commodity Classifi** 

**cation A**  **ve.**

**% CT Max** 

**% CT Source of Data**  **# of FTD**  **# of zeroes in**  **RDF sum** 

**(FTD) mean of** 

**RDF or**  **FTD 1**  **PF Acute**  **Value Chronic** 

**Value** Pepper, dried B 15 30 highest FTD (DP#: 244253) 30 70 1.005 0.0 2 01 0.0 2 01 0. 067 Pepper, dry (bell or non

bell) B 15 30 highest FTD (DP#: 244253) 15 70 1.005 0.0 2 01 0.0 2 01 0
. 067
Plums

-prunes NB 100 100 FTD (DP#: 325479) 22 0 0.99 0.0450 rdf 0.045 Plums

-prunes (dried) PB 100 100 FTD (DP#: 325479) 22 NA 0.99 0.0450 4 0.045 x PF 0.045 x PF Pork NB 100 100 T olerance tolerance tolerance Pork, fat NB 100 Tolerance (a) /Anticip Res (c) tolerance 0.0 16 Potato NB 1 2.5 FTD/T olerance 1 39 0.01 0.00025 rdf 0. 01 x fCT Potato (dry , chips) B 1 2.5 average FTD 1 NA 0.004 0.0001 0.85 0.0001 x PF 0.0 04 x fCT x PF Potato, flour B 1 2.5 average FTD 1 NA 0.004 0.0001 0.0001 0.004 x fCT Poultry, fat NB 100 100 see text 0.457 0.457 Poultry, liver NB 100 100 see text 0.052 0.052 Poultry, meat NB 100 100 see text 0.045 0.045 Poultry, meat byproduct NB 100 100 see text 0.052 0.052 Poultry, skin NB 100 100 see text 0.079 0.079 Ruminants NB 100 100 tolerance tolerance tolerance Ruminants, fat NB 100 Tolerance (a) /Anticip Res (c) tolerance 0.01 6 Soybean B 1 2.5 average FTD 1 NA 0.088 0.0022 0.64 (for oil) .0022 x PF 0. 088 x fCT x PF Spinach NB 2.5 5 FTD (DP#: 325479) 16 304 84.3 0.2634 rdf 5.27 x fCT Squash NB 100 100 FTD (DP#: 325479) 22 0 0.729 0.0331 rdf 0.0331 Subgroup 1C, except potato NB 100 100 tolerance 1 NA 0.01 0.01 0.01 0.01 Subgroup 4A, the rest (not spinach & lettuce) NB 100 100 FTD (DP#: 325479) 16 0 84.3 5.2688 rdf 5.2 7 Subgroup 4B NB 100 100 Celery FTD (DP#: 325479) 12 0 23.2 1.9333 rdf 1.93 Subgroup 5A , except broccoli and cabbage PB 5 0 70 broccoli FTD 20 8 12.95 0. 4625 rdf 0. 648 x fCT
Subgroup 5B PB 100 100 Mustard green FTD (DP#: 325479) 8 0 47.8 5.9750 rdf 5.9750 Subgroup 9A, melons NB 100 100 Cantaloupe FTD (DP#: 325479) 22 0 2.236 0.1016 rdf 0.1016 Subgroup 9B except cucumber NB 100 100 summer squash FTD (DP#: 325479) 22 0 0.729 0.0331 rdf 0.0331Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **9** of **41 Table**  **2 . Data and Residue Estim**  **ates Used in the Acute and Chronic Dietary Analyses**  **Commodity Classifi** 

**cation A**  **ve.**

**% CT Max** 

**% CT Source of Data**  **# of FTD**  **# of zeroes in**  **RDF sum** 

**(FTD) mean of** 

**RDF or**  **FTD 1**  **PF Acute**  **Value Chronic** 

**Value** Tomatoes PB 20 40 highest FTD ( DP#: 244253) 25 37 6.75 0.10 8 rdf 0.27 x fCT Tomatoes, dried B 20 40 highest FTD (DP#: 244253) 25 37 6.75 0.108 14.3 0.108 x PF 0.27 x fCT x PF Tomatoes, paste B 20 40 highest FTD (DP#: 244253) 25 37 6.75 0.108 1.4 0.108 x PF 0.27 x fCT x PF Tomatoes, puree B 20 40 highest FTD (DP#: 244253) 25 37 6.75 0.108 0.52 0.108 x PF 0.27 x fCT x PF Subgroup 8, except tomato and pepper 20 40 highest FTD (DP#: 244253) 1 NA NA 0.27 0.27 0.27 Water (all sources) see text 0.05926 0.01848 NA = Not applica

ble 1 The mean of the RDF or FTD may be adjusted by the maximum %CT. 2 When the highest or mean FTD is used, the #FTD may be set higher than one in order to obtain an integer for the # of zeros in rdf. 

### Food Residues

**– Details**  Note that for the chronic as sessment further refinement was performed to support the aggregate risk assessment (food and residential). Bean, guar seed: T he t olerance and average residue of dry beans was used as a point estimate for acute and chronic assessments , respectively , since guar seed is exclusively under the dry

beans section of the proposed label

. All the remaining beans are under dry and/or succulent bean section of the label; therefore, the highest residue corresponding to the succulent commodity was used in the dietary assessment, see below. Bean (the rest) : The tolerance and average residue of succulent bean was used as a point estimate for acute and chronic assessments , respectively

. Bushberries (blueberries) : RDF and average field trial data w ere used as a point e stimate for acute and chronic assessments, respectively

. Beet, Garden (roots and tops): RDF and average field trial data were used as a point estimate for acute and chronic assessments, respectively

. Vegetables, leafy, except Brassica, group 4: The submitted field trials for celery and spinach were conducted at different pre

- harvest intervals (PHI s) (celery at 7
- , 14

- , and 21

- day

PHI s while spinach at 3

- , 7
- , and 14

- day PHI s). The proposed label for leaf y petiole vegetables (celery is in subgroup 4 B) lists 3

- day

PHI , 3

- day

retreatment interval (RTI), maximum seasonal application of 0.26 lb ai/A. Note that data are not available for untrimmed celery at the proposed PHI

of 3 day s. However, HED used the trimmed celery residue data to estimate untrimm ed celery residues asIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **10** of **41** follows: Indoxacarb residue concentrations in trimmed and untrimmed celery were compared for 0

- day , 7
- day , and 14

- day

PHIsamples. Based on this comparison, trimmed to untrimmed ratios were determined to be 2.32 for the 0

- day PHIsamples, 3.0 for the 7

- day PHIsamples and 2.3 for the 14

- day

PHIsamples. The average residue ratio for these three sampling intervals was calculated to be 2.5. The 3

- day trimmed celery

residue data were entered into the MRL calculator, resulting in a tri mmed celery tolerance of 3.5 ppm. To determine an untrimmed tolerance value, the 3.5 ppm value was multiplied by the average trimmed to untrimmed residue ratio of 2.5, resulting in a value of ~9.0 ppm. Therefore, for celery , the trimmed, 3

- day PHIcelery FTD were multiplied by 2.5 and used in an RDF (Indoxacarb

- 040907

- 3

- day PHI
- UntrimdCelery .rdf). This RDF, with assumption of 100% CT was used for all subgroup 4B crops (leaf petiole vegetables). For the chronic assessment, the average of the celery

FTD an d average %CT were used. For lettuce and spinach, their corresponding FTD and %CT were used in three separate RDFs (leaf lettuce, head lettuce and spinach). The crops had the same use rates (4 applications, maximum use rate

– 0.26 lb ai/A, 3

- day

PHI). F or the remaining RACs of crop subgroup 4A (leafy greens subgroup), spinach FTD with 100% CT assumptions were used. The average residue value and %CT were used in the chronic assessment. 100% of CT was assumed for all crops other than lettuce and spinach. Brassica, leafy, group 5: Broccoli, cabbage, and mustard green FTD are available (S. Levy, 19

- J an - 2000, DP#: 244253 and 18

- F eb

- 2005 , DP#: 290126) and were within 5x of each other, with mustard green FTD being the highest. The suggested use rate is the same for all crops in this group (maximum application rate = 0.26 lb ai/A, PHI=3 days). Broccoli field trials were not conducted at a 1x application rate; therefore, broccoli FTD were used for broccoli only after being adjusted for rate of exaggeration (multiplied by 0.67; see DP#: 244253, page 119) and cabbage FTD were used for cabbage only . For the rest of the crop subgroup 5A, broccoli FTD (higher residues than cabbage) adjusted for zeroes with %CT for broccoli (highest %CT in that subgroup and in all crops), were used. The average residue value and %CT were used for subgroup 5A in the chronic assessment. For crop subgroup 5B, mustard green FTD with 100% CT were used (no %CT on any of the crops in subgroup 5B are available). The average residue value and 100%CT was assumed for crop subgroup 5B in the chronic assessment. Cranberry: The submitted FTD with assumption of 100% CT were used in an RDF. The average field trial value was used in the chronic assessment. The DEEM

- FCID  default PF for cranber ry juice (1.1) was used. Cottonseed oil: The average FTD and the empirical PF (0.04x) as adjustment factor were used. Corn: The highest FTD were used in an RDF incorporating zeroes corresponding to %CT. For the chronic assessment, the highest field trial value and average %CT were used.Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **11** of **41** Cucurbit Vegetables (group 9): Cantaloupe, summer squash, and cucumber FTD with 100% CT assumptions were used for group 9 crops. Cantaloupe data were used for all melons (subgroup 9A) and summer squash data (higher than cucumber data) were utilized for all crops in subgroup 9B except for cucumber. For the chronic assessment, average field trial data with 100% CT assumptions were used. Fruiting Vegetables (group 8): FTD were submitted for non

- bell pepper, bell peppe r, and tomatoes (S. L evy , 19

- J an - 2 000 , DP#: 244253), with residues being highest for tomatoes. The highest FTD residue for both non

- bell pepper and bell pepper which was adjusted for the rate exaggeration was 0.067 ppm and that for tomato FTD was 0.27 ppm . These values and the average %CT were used in the chronic assessment. For the acute assessment, two RDFs were generated for pepper and tomatoes, using their highest FTD and incorporating the available %CT values; the se RDFs were used for corresponding crops. For the rest of this group (eggplant, tomatillo, and okra), the highest FTD for tomatoes (0.27 ppm) were used in the chronic and acute assessments, as well as 100% CT assumptions . Empirical PFs for tomato paste (1.4x) and puree (0.52x) were used. The PF for tomato puree (0.52x) was also used for tomato juice. The DEEM

- FCID  default PF for dried tomato (14.3x) was used. Fruit Stone, group 12: FTD for cherries, peaches, and plums with the same use rate were submitted; FTD residues were highest fo r cherries. The registrant requested four applications with a maximum use of 0.44 lb ai/A and 14

- day PHI . The submitted FTD were used for the respective crops in DEEM

- FCID  as (in form of RDFs). For other crops in group 12, FTD for the similar fruit wer e used. %CT data were only available for cherries and peaches which were incorporated in their respective RDFs. The average FTD and %CT were used for cherries and peaches in the chronic assessment. For other crops in group 12, 100% CT were assumed. An empirical PF of 4x was used for dried plums. For the other crops in group 12, DEEM

- FCID  default PFs were used for juice and the dried food form. Grape, grape juice, raisins: Grape FTD with 100% CT assumptions were used to construct an RDF for grape, gr ape juice and raisins. The average field trial residue and average %CT was used in the chronic assessment. PFs (as adjustment factors in DEEM

- FCID  ) were also incorporated (PF for grape juice/wine and sherry =0.007, PF for raisins=2.7). Mint: The average of the submitted mint FTD were used as a point estimate (assuming 100% CT) for peppermint, spearmint, and their corresponding oil in the acute and chronic assessments. Mint and mint oil are considered blended commodities. An empirical PF (0.028x) was us ed for mint oil. Pome Fruit group (11): Apple, apple juice, dried apple: The highest FTD for apple which were adjusted for rate of exaggeration (0.74 ppm) were used in an RDF. The RDF also incorporated zeroes according to %CT. For the chronic assessment , the highest field trial data and average %CT were used. An empirical PF of 0.01 was used for apple juice, and a DEEM
- FCID  default PF of 8 was used forIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **12** of **41** dried apple. Pear, pear juice, dried pear: The highest FTD for pear which were adjusted for rate o f exaggeration (0.08 ppm) were used in an RDF. The RDF also incorporated zeroes according to %CT. For the chronic assessment, the highest field trial data and average %CT were used. A PF for apple juice (0.01) was translated to pear juice, and a DEEM

- FCID  default PF of 6.25 was used for dried pear. For the rest of the crops in group 11, the apple RDF with the same %CT was used in the acute assessment while the highest field trial value was used in the chronic assessment with 100% CT assumptions

. Peanu t, peanut butter, peanut oil : All are considered blended commodities. The highest FTD for peanut (0.003 ppm) with % CT were used to deri ve a point estimate for acute. F or chronic , the highest field trial value with average %CT was used . An empirical PF of 1.4x was used for peanut oil and DEEM

- FCID  default PF of 1.89x was used for peanut butter. Soybean: Since all the soy bean food forms are blended, the average FTD (0.088 ppm) (S. Levy , 30

- MAY

- 2002; DP#: 276516) were used as a point estimate in conjun ction with PF (0.64x for soy bean oil only

) and %CT value. Tuberous and corm vegetables, subgroup 1C: Potato: For non
- blended food forms, a tolerance

- level residue (0.01 ppm) was used in the RDF with inserting zeroes according to %CT value. The tolerance level and average %CT were used in the chronic assessment. For blended food forms (dry potato, chips, flour), the average field trial value (0.004 ppm) adjusted for the %CT, and PFs (0.85x for chips and dry potato) were used (S. Levy , 30

- M ay- 2002; D276516 )

. The tolerance level residue (0.01 ppm), with assumption of 100% CT were used for the rest of the crops in subgroup 1C.
**Livestock Commodities -**  **Details** Poultry : From the poultry metabolism study , the ratios of all the metabolites of concern to those that were measured in the feeding study were calculated to be: 1.81 for egg yolk, 2.8 for fat, 1.5 for muscle, 2.5 for liver, and 1.8 for skin (DP#: 244253). These ratios were multiplied by estimated measured residues in each tissue in the feeding study to arrive at the total metabolites of concern. The following dietary

burden in conjunction with the feed

- tissue chart was used to estimate the measured residues in each tissue. As per HED policy , residues in poultry tissues were not adjusted for % dry matter (DM). The calculated dietary burden is 2.72 ppm (electronic communication, J. Stokes, 17

- Apr - 2007).Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **13** of **41 Table**  **3 . Calculation of Poultry Dietary Burden.**  **Feedstuff %DM**  **Classification Tolerance**  **% In Diet Dietary Burden**  Corn, grain NA CC 4 0 70 0 Whe at, grain CC 0 5 0 Soybean, meal 1 PC 5 0.8 15 0.12 Cottonseed, meal 2 PC 2.0 5 0.10 Alfalfa, meal 3 PC 50 5 2.50 **Total 100**  **2.72** 1 Based on soy

bean seed tolerance 2 Based on undelinted cottonseed tolerance 3 Based on alfalfa hay tolerance 4 C C = carbohydrate concentrate 5 PC = protein concentrate 

### The estimated residues of concern were used as a point estimate in DEEM

- FCID  for the corresponding poultry

tissues in both acute and chronic assessments, assuming 100% CT. The estimated residue v alue in poultry liver tissue was used for meat by

- product tissues. Refer to M. Sahafeyan ( DP # 339398; 23

- M ay- 2007) for the anticipated residue calculations. Ruminants (beef, goat, sheep, and horse) and Pork: Corresponding tolerance values as point estimates (assuming 100% CT) were used for both acute and chronic assessments for all ruminant commodities with the exception of ruminant fat and milk for which anticipated residues were calculated to support the chronic assessment. Inorder to refine the chronic assessment anticipated residues in milk and ruminant fat were estimated using dietary

burden calculations that incorporated highest or average residues and average %CT. A livestock dietary burden calculator developed by HED was used to estimate the d ietary burden for dairy

cattle , and then the % crop treated was incorporated

. Since average residues in feedstuff commodities can be used to construct dietary burden to support chronic dietary assessment , the estimate below (8.78 ppm) is lower than that r eported in the residue chemistry chapter (33.0 ppm). Moreover, incorporation of percent of crop treated estimates lead to lower dietary

burden estimates (0.229 ppm). For the remaining ruminant commodities tolerance level residues were assumed. **Table 4. Refined Dietary Burden for Dairy Cattle to Support the Chronic Dietary Assessm**  **ent of Indoxacarb. Feedstuff**  **%DM Classific**  **ation** 1 **Highest/**

**Average Residue**  **2 % In Diet**  **Dietary Burden**  **%Crop**

**Treated Refined** 

**Dietary Burden**  Apples, Pomace, wet 40 CC 1.9 10 0.4 8 5 0.024 CC 35 (NU) 0.00 Cotton, undelinted seed 88 PC 1.3 10 0.15 1 0.001 Corn, sweet, forage 48 R 8.7 45 8.16 2.5 0.204 **Total 100**  8.78 **0.229** 1 CC = carbohydrate concentrate; PC = protein concentrate; R = roughage 2 The residue values used to determine the dietary burden are included in Attachment #5.Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **14** of **41** Milk: The dietary

burden of 0.229 ppm is anticipated to result in 0.000573 ppm indoxacarb residue in whole milk based on the feeding study ( D 276518 , 5/30/2002 ) and a constructed dose

residue chart ( D339398, 5/23/2007 ) . However, the residues of concern are indoxacarb and MP

819. From metabolism study (D244253, p.141), the highest ratio of metabolites of concern to indoxacarb is 1.82; therefore, the estimated highest residues of concern in wh ole milk is 0.0 0104 ppm. Due to high lipophi licity of indoxacarb (KOW 

### = 4.65 at pH 5) those residues are expected to be concentrated in the milk fat. Therefore, the residues in milk fat are estimated to be at 0.026 ppm ( i.e. , 0.0 0104 / 4% *100 , assuming mi lk fat is 4% of whole milk). From the same feeding study residues in cream and skim milk were also measured; however, the fat content of the cream is undetermined and thus, those data for cream can not be used. The expected indoxacarb residue in skim mil k from the dose

- residue chart is 0.0 00229 ppm; therefore, considering the residues of concern the expected residue is 0.0 0042 ppm ( i.e. , 0.0 00229 *1.8). With the assumption that the residues are concentrated in non

- fat solids of the skim milk (~ 8% of the m ilk w/w), the estimated residues in non

- fat solids is 0. 0052 ppm ( i.e. , 0.0 0042 / 8% *100 ). No residues are expected in milk water and lactose. Refer to M. Sahafeyan ( DP # 339398; 23

- M ay- 2007) for the anticipated residue calculations. Fat of ruminants (beef, goat, sheep, and horse ) and pork: The dietary burden of dairy

cattle is higher than that of beef cattle; therefore, is appropriate to base the anticipated residues in the former. The feeding study doesn’t show an increase of residue level with incr ease of dose administered; therefore, a linear regression is not appropriate in this case. Based on this the tissue to feed ratio was obtained from the 7.5 ppm dose which correspond to the highest and most conservative ratio. The anticipated residue in r uminant fat is 0.016 ppm ( i.e. 0.229 * 0.52 / 7.5). Note that monitoring data from the 2009 Pesticide Data Program show no detects (0.05 ppm L OD) in 292 samples of adipose beef tissue.

**III. Percent Crop Treated Information** The following maximum percent crop treated estimates (BEAD Report, October 12, 2012, Reporting Years: 2004

- 2011, see Attachment 4) were used in the acute dietary risk assessment for the following crops that are currently registered for indoxacarb: apples: 10 %; broccoli: 70%, cabbage: 35%; cauliflower: 60%; cherries: 2.5 %; lettuce: 40%; peac hes: 2.5%; peanuts: 10%; pears: 2.5%; potatoes: 2.5%; soy beans: 2.5%; spinach: 5%; sweet corn: 10 %; tomatoes: 40% . The following average percent crop treated estimates were used in the chronic dietary risk assessments **Table 5. Residues of indoxacarb in fat from the feeding study with**  **r uminants (D244253, S. Levy, 01/19/2000)**  **Dose (ppm )**  **Residue of R -**  **and S -**  **enantiom ers (ppm** **)**

7.5 0.52 22.5 0.39 75 0.42Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **15** of **41** for the following crops that are cur rently registered for indoxacarb apples: 5%; broccoli: 50%, cabbage: 25%; cauliflower: 40%; celery : 5%; cherries: 1%; grapes: 1%; lettuce: 10%; peaches: 2.5%; peanuts: 2.5%; pears: 1%; potatoes: 1%; soy beans: 1%; spinach: 2.5 %; sweet corn: 2.5 %; tomatoes: 20 %. For all other crop commodities with indoxacarb uses, including the proposed uses (dry bean, succulent bean and low growing berry subgroup (except strawberry ) 13

- 07H), 100% of the crop treated was assumed.
**IV .**  **Drinking Water Data** Reference: C. Koper, D402100, 06

- Nov
- 2012. A Tier I I screening

- level drinking water assessment was conducted to support the human health risk assessment for the proposed new use registration for indoxacarb. Modeled application rates represent the maximum application rates from the proposed labels (DuPont TM Avaunt ® 

### , EPA Reg. No. 352

- 597 and DuPont TM Steward ® 

### EC, EPA Reg. No. 352

- 638) for use on dry beans, snap beans, small fruit vine climbing subgroup 13

- 07F and low

- growing berry subgroup 13

- 07H. For dry and snap beans and the low

- growing berry subgroup, the proposed maximum application rate is 0.44 lbs. a.i./acre (4 applications at 0.11 lbs. a.i./acre). For cranberry and the small fruit vine climbing subgroup, the proposed maximum application rate is 0.22 lbs. a.i./acre (2 applications at 0.11 lbs. a.i./acre). In addition, aerial and ground foliar spray applications and chemigation techniques are the proposed application methods. Based on the Metabolism Assessment Review Committee (MARC) recommendations, a Total Toxic Residue (TTR) approach was used for the parent indoxacarb and the degradation products with toxicological concern (I N
- JT333, I

N
KG4333, I

N
- KT413, I

N
- ML437

- 0H) for the drinking water assessment. The recommended estimated drinking water concentrations (EDWCs) for the human health ris k assessment are based on highest predicted value for surface water and groundwater (Table 5), which are based on two applications of 0.11 lbs. a.i./acre/season on cranberry and four applications of 0.11 lbs. a.i./acre on b eans and berries respectively

. For acute and chronic dietary risk assessments, the 1

- in

- 10 year peak ( **59.26 ppb** ) and the 1

- in

- 10 year annual average, ( **18.48 ppb** ) indoxacarb residues of concern in water from cranberry scenario were used.

**Table 5. Re commended Estimated Drinking Water Concentrations (EDWCs)**  **1** 

### for Surface Water **and Ground Water Drinking**  **Water Source**  **Model**

**Scenario Method**  **2 Maxim**  **um Application Rate**  **(interval between applications)**  **1 -**  **in -**  **10**

**year acute**  **(** 

### μg/L **) 1**  **- in**  **- 10** 

**year chronic**  **(** 

### μg/L **) 30**  **- year** 

**average (**  

### μg/L **)** Surface Provisional Cranberry Model PCM 2 app @ 0.11 lb a.i./acre **59.26 18.48**  18.48Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **16** of **41 Table 5. Re**  **commended Estimated Drinking Water Concentrations (EDWCs) 1**  

### for Surface Water **and Ground Water Drinking**  **Water Source**  **Model**

**Scenario Method**  **2 Maxim**  **um Application Rate**  **(interval between applications)**  **1 -**  **in -**  **10**

**year acute**  **(** 

### μg/L **) 1**  **- in**  **- 10** 

**year chronic**  **(** 

### μg/L **) 30**  **- year** 

**average (**  

### μg/L **)** Water Cranberry Ground Water SCI

- GROW

(Beans, Berries) -- 4 app @ 0.11 lb a.i./acre 0.33 0.33 0.33 1 For surface water (PRZM/EXAMS), EDWC values adj usted with a Percent Cropped Area (PCA) factor of 0.87. For ground water (SCI

- GROW), no PCA adjustment was utilized. 2 PCM = The Provisional Cranberry Model (PCM) is a provisional refinement to the Tier I Rice Model (v1.0, May 8, 2007). Refinements i nclude the addition of simple degradation processes in dry and flooded conditions and a water depth of twelve inches, rather than the water depth of four inches used in the rice model. These modifications allow estimation of screening

- level peak and annual mean EDWCs of residues of concern that may occur in untreated surface water used as drinking water following use on cranberries.



### V. DEEM **- FCIDTM Program and Consumption Information**  In doxacarb acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM

- FCID, Version 3.16, which incorp orates 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 day s. Foods “as consumed” (e.g., apple pie) are linked to EPA

- defined food commod ities (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 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 acc ount 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, a dults 20

- 49, females 13

- 49, and adults 50

- 99 ye ars 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 da ily 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. For an acute exposure assessment, individual one

- day food consumption data are used on anIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **17** of **41** individual

- by

- individual basis. The reported consumption amounts of each food item can be multiplied by

a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matche d” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/fo od forms) and a per

- capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy , per capita exposure and risk are reported for analyses performed at all levels of refinement. However , for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specifically

identified and noted in the risk assessment.
**V I**  **. Toxicological Information** Table 6 below summarizes the HED decisions on endpoints a s related to the dietary risk assessment as adapted from the Human Health Risk Assessment (D. Drew, D402099, In Progress )

. **Table 6. Sum ma**  **ry of Toxicological Doses and Endpoints for Indoxacarb for Use in Dietary Exposure Assessment**  **1**
**. Exposure**  **Scenario Do**  **se for Use in Risk Assessment,**  **UF** **FQPA SF* and**

**Level of Concern for Risk**  **Assessment Study and Toxicological Effects**  Acute Dietary females 13

- 49 years ofage An endpoint of concern specific to females 13

- 49 and attributable to a single dose was not identifi ed in the toxicity study data base, thus an acute RfD was not established. Acute Dietary general population including infants and children NOAEL= 12 mg/kg

UF = 100 **Acute RfD** = 0.12 mg/kg UF A= 10x UF H =10x FQPA SF = 1x **aPAD** = = 0.12 mg/kg A cute oral rat neurotoxicity study.

LOAEL = 50 mg/kg based on decreased body weight and body

we ight gain in females (MP062) Chronic Dietary all populations NOAEL= 2.0 mg/kg/day

UF = 100 **Chronic RfD** = 0.02 mg/kg/day UF A= 10x UF H =10x FQPA SF = 1x **cPAD** = = 0.0 2 mg/kg/d ay Weight of evidence approach was

used from four studies: 1) Subchronic toxicity study

- rat (MP062) 2) Subchronic neurotoxicity study

- rat (MP062) 3) Chronic/carcinogenicity study

- rat (JW062) 4) Two generation rat reproduction study (JW062). LOAEL = 3.3 mg/kg/day based on decreased body weight, body

we ight gain, food consumption and food efficiency; decreased hematocrit, hemoglobin and red blood cells only at 6 months.Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **18** of **41** Cancer (oral, dermal,inhalation) “Not likely” to be carcinogenic to humans since n o evidence of carcinogenicity in either the rat or mouse studies, and no evidence of mutagenicity. 1 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapol ation 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 (interspec ies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF L = use of a LOAEL to extrapolate a NOAEL. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference do se. N/A = not applicable.


### V **I. Results/Discussion** As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the aPAD and cPAD, respectively . The DEEM

- FCIDTM analyses estimate the dietary exposure of the U.S. population and various population subgroups. The acute and chronic results reported in Tables 7 and 8 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. Acute Dietary

Exposure Results Estimated acute dietary

exposure to indoxacarb from food and drinking water is below HED’s level of concern for all population subgroups. Combined dietary exposure from food and drinking water at the 99.9 th 

### percentile of exposure is estimated to be 0.032 762 mg/kg/day for the overall U.S. population, equivalent to 27 % of the aPAD. The population subgroup with the highest estimated acute dietary

exposure to indoxacarb is all infants , with an estimated exposure at the 99.9 th 

### percentile of 0.0 58 294 mg/kg/day , equivalent to 49 % of the aPAD. **Table 7**  **. Sum ma**  **ry of Acute Dietary (Food + Drinking Water) Exposure and Risk for Indoxacarb Population Subgroup**  **aPAD (m**  **g/kg/day) 95**  **th Percentile**  **99th Percentile 9**  **9.9th Percentile**

**Exposure (m**  **g/kg/day) %** 

**aPAD Exposure**  **(m g/kg/day)**  **%**

**aPAD Exposure** 

**(m g/kg/day)**  **%**

**aPAD** General U.S. Population

0.12 0.009954 8.3 0.017531 15 0.032762 27 **All Infants (< 1 year old)** 0.016632 14 0.023797 2 0 **0.058294 49**  Children 1

- 2 years old 0.021818 18 0.030424 25 0.054158 45 Children 3

- 5 years old 0.016529 14 0.026494 22 0.046841 39 Children 6

- 12 years old 0.010843 9 0.016818 14 0.035434 30 Youth 13

- 19 years old 0.006731 5.6 0.010642 8.9 0.025623 21 Adults 20

- 49 years o ld 0.007453 6.2 0.012442 10 0.025109 21 Adults 50+ years old 0.007340 6.1 0.013368 11 0.030965 26 Female 13

- 49 0.007511 6.3 0.013145 1 1 0.026456 2 2 The population subgroup with the highest estimated acute dietary (food + drinking water) exposure and risk is indicated by bold text.



### Chronic Dietary

Exposure ResultsIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **19** of **41** Estimated chronic dietary exposure to indoxacarb from food and drinking water is below HED’s level of concern. Combined dietary exposure from food and drinking water is estimated at 0.0 0 1133 mg/kg/day

for the general U.S. population ( 5.7 % of the cPAD) and 0.0 02381 mg/kg/day ( 1 2 % of the cPAD) for children, 1 to 2 years old, the population subgroup with the highest estimated chronic dietary exposure to indoxacarb.

**Table 8**  **. Sum ma**  **ry of Ch ronic Dietary (Food + Drinking Water) Exposure and Risk for Indoxacarb.**  **Population Subgroup cPAD (m**  **g/kg/day) Exposure (m**  **g/kg/day) % cPAD**  General U.S. Population

0.0 2 0.001133 5.7 All Infants (< 1 year old) 0.001772 8.9 **Children 1 -**  **2 years o ld**  **0.002381 12**  Children 3

- 5 years old 0.00181 8 9.1 Children 6

- 12 years old 0.001105 5.5 Youth 13

- 19 years old 0.000743 3.7 Adults 20

- 49 years old 0.001036 5.2 Adults 50+ years old 0.001 165 5.8 Females 13

- 49 years old 0.001037 5.2 The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and risk is indicated by bold text. 

### Results of the acute and chronic dietary asse ssment are summarized in Table 9. **Table 9. Summary of Dietary (Food and Drinking Water)**  **Exposure and Risk for Indoxacarb Population Subgroup**  **Acute Dietary (99.9 Percentile)**  **Chronic Dietary Cancer**  **Dietary Exposure**  **(m g/kg/day)**  **% aPAD*** **Dietary Exposure**  **( mg**  **/kg/day) % cPAD** * **Dietary Exposure**  **(m g/kg/day)**  **Risk** General U.S. Population 0.032762 27 0.001133 5.7 All Infants (<1 year old) **0.058294 49**  0.001772 8.9


### N/A N/A Children 1

- 2 years old 0.054158 45 **0.002381 12**  Children 3

- 5 years old 0.046841 39 0.001 818 9.1 Children 6

- 12 years old 0.035434 30 0.001105 5.5 Youth 13

- 19 years old 0.025623 21 0.000743 3.7 Adults 20

- 49 years old 0.025109 21 0.001036 5.2 Adults 50+ years old 0.030965 26 0.001165 5.8 Females 13

- 49 years old 0.026456 22 0.00103 7 5.2 *T he subpopulation(s) with the highest risk estimates (Insert an asterisk after the population subgroups with the highest risk estimates and highlight the subpopulations in bold print)



### VII **I . Characterization of Inputs and Outputs** Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **20** of **41** These analyses are considered to be refined dietary exposure assessments. In some cases, tolerance

- level residues, empirical processing factors, default DEEM processing factors, and/or 100% CT data were used. Refinement was conducted for some commodities by using f ield trial data and %CT assumptions. Anticipated residues in milk and ruminant fat were calculated to further refine the chronic risk assessment and support the aggregate assessment (dietary and residential exposure). Further refinement of residue levels for some commodities could be made through the use of ARs, and incorporation of %CT and/or monitoring data that better reflect residues at the time of consumption. Since both acute and chronic risk estimates are below HED’s level of concern, more highly refined analyses are not needed at this time. Itis noted that the consumption database used in the current assessment is based on data obtained in surveys conducted from 2003 to 2008 (NHANES/WWEIA) while the database used in the previous assessment (S. Tadayon ; D 360559 , 18

- Feb

- 200 9 for acute and D364939, 13

- May
- 2009 for chronic ) was based on survey s conducted from 1994

- 1996 and 1998 (USDA’s Continuing Survey s of Food Intakes by Individuals). The consumption database used is reflective of the most current consumption patterns and may result in different exposures for some commodities

.
**IX . Conclusions**  The results of the acute and chronic dietary assessments indicate that dietary exposure to indoxacarb from food and drinking water is below HED’s lev el of concern for the general U.S. population and all population subgroups. HED is confident that the assessments do not underestimate risk to the general U.S. population or any population subgroup.
**X. List of Attachments** 

 RDFs for the Acute Analysis  Acute Foo d plus Water Residue Input file and Acute Results file.  Chronic Foo d plus Water Residue Input file and Chronic Results file.  Percent Crop Treated Memo from BEAD.Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **21** of **41 Attachment**  **1: RDFs for the Acute Analysis**  RDF 1 Apple, highest adjusted FTD (D244253, p.128)=0.74 ToTALZ= 9 doc max %CT=10% 1 ,0.74 RDF 2 Indoxacarb, Blu e berry doc max CT=100% totalz=0 0.20 0.27 0.28 0.30 0.32 0.35 0.38 0.38 0.42 0.51 0.52 0.53 0.55 0.56 0.58 0.58 0.59 0.63 0.73 0.80 0.81 0.81 0.84 0.84 1.03 1.04 RDF 3 Indoxac arb

- Broccoli doc Max %CT=70% ToTALZ=8 doc adjusted for exaggeration rate(multiplied by 0.67) (MRID 44477401) 0.19 0.23 1.34 1.5 0.57 0.62 0.25 0.45 1.34 1.68 0.80 RDF 4 Indoxacarb

- subgroup 5A, Broccoli FTD, do c Max %CT= 70 % of Broccoli (highest) ToTALZ= 8 doc adjusted for exaggeration rate(multiplied by 0.67) (MRID 44477401) 0.19 0.23 1.34 1.5 0.57 0.62 0.25 0.45 1.34 1.68 0.80 0.94 0.26 0.52 0.36 0.49 0.23 0.26 0.38 0.54Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **22** of **41** 0.94 0.26 0.52 0.36 0.49 0.23 0.26 0.38 0.54 RDF 5 Indoxacarb

- Cabbage without Wrapp er Leaves doc Max %CT= 35 % ToTALZ= 4 4 0.02 0.04 0.01 0.03 0.08 0.11 0.05 0.05 0.03 0.07 0.06 0.1 0.01 0.02 0.11 0.21 0.02 0.03 0.03 0.04 0.02 0.02 0.03 0.08 RDF 6 Indox

- Cherries, 46651504.der doc max CT= 2.5 Totalz=1248 .07 .07 .15 .45 .22 .19 .15 .16 .3 .51 .24 .12 .26 .31 .13 .62 .07 .07 .15 .45 .21 .19 .15 .15 .32 .51 .28 .15 .26 .32 .13 .64 RDF 7 Indoxacarb, Mustard Green FTD, PHI=3 days, D290126, 45718701.der doc max CT=100% totalz=0 3.5 3.4 1.2 1.2 9.6 10 9.5 9.4Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **23** of **41** RDF 8 Indoxacarb

- Head Lettuce w/o wr apper leaves doc 40 % CT Max (of lettuce) TOTALZ= 27 0.033 0.016 0.067 0.082 0.051 0.044 0.14 0.24 0.061 0.047 0.11 0.029 0.48 0.34 0.13 0.24 1.1 0.76 RDF 9 Indoxacarb

- Leaf Lettuce doc 40 % CT Max (of lettuce) TOTALZ= 27 8 8.7 6.8 7.9 6.6 5.6 3.5 4. 6 6.6 7.7 5.9 7.2 8.3 8.1 3.4 3.7 2.7 2.9 RDF 10 Indox

- Peach FTD, 46651505.der ToTALZ=1170 doc max CT=2.5% .07 .26 .13 .03 .04 .1 .09 .3 .16 .19 .58 .07 .06 .29 .13 .04 .04 .3 .16 .2 .59 .07 .09 .09 .09 .09 .1 .1 .1 .1 RDF 11 Indox

- Pear, highest FTD, D244253, p.128 doc max CT=2.5% ToTALZ=39 0.08 RDF 12 Indox

- tomato, highest adjusted FTD, D244253 ToTALZ= 60
40 ,0.27 RDF 13 Indox

- fruiting veg. besides pepper and tomatoes doc highest adjusted FTD for tomatoes is used, D244253 ToTALZ=0 doc max % CT=10 0% 0.27 RDF 14 Indox

- Corn Sweet(k+CWHR), adjusted highest FTD, D244253 RDF 15 Indox

- pepper(bell or non

- bell), FTD, D244253 RDF 1 8

- 20 blankIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **24** of **41** ToTALZ= 9 doc max %CT= 10 0.008 doc highest FTD used (adjusted for exaggeration) doc max CT=30% ToTALZ=70 30,0.067 RDF 21 Indox

- Mint, FTD, 46520902.der doc max CT=100% totalz=0 6.84 5.9 5.3 6.81 3.61 2.62 2.24 2.73 2.18 2.1 2.75 3.36 RDF 22 Indox

- Spinach FTD, 46487001.der doc max CT=5% totalz=304 7.9 13 2.5 4.5 3.7 3.3 5.7 5.7 4.7 4.3 4.3 4.2 7.2 6.7 2.2 4. 4 RDF 23 Indox

- Plum, FTD, 46651506.der doc max CT=100% TotalZ=0 .01 .01 .02 .02 .02 .03 .07 .04 .07 .19 .02 .02 .01 .02 .02 .02 .03 .07 .04 .07 .18 .01 RDF 24 Indox

- trimmed celery, FTD x 2.5, see p.14 of D325479 doc max CT=100% totalz=0 0.155 0.145 3.2 5 3 1.075 1.375 1.9 1.325 1.05 RDF 25 Indox

- southern pea, FTD, 46520901.der doc max CT=100% totalz=0 4,.01 .0670 .0630 .0130 .0140 .0110 .0110 .0330 .0200 .0150 RDF 26 Indoxacarb, Grapes, FTD, D290126, 45900301.der, PHI=7 days doc max CT=100% totalz=0 0.196 0.163 1.72 1.32 0.133 0.198 0.105Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **25** of **41** 1.175 4.75 4 .0320 0.0661 0.306 0.328 0.448 0.423 0.292 0.0888 0.482 0.353 1.35 1.31 0.447 0.329 RDF 27 indox

- squash, FTD, 46651503.der doc max CT=100% totalz=0 0.12 .014 .11 .04 .01 .022 .035 .012 .026 .01 .01 .08 4 .013 .048 .032 .01 .034 .026 .013 .028 .01 .022 RDF 28 Indox

- Cucumber, FTD, 46651502.der doc max CT=100% totalz=0 .018 .015 .025 .025 .01 .023 .04 .031 .013 .019 .016 .02 .028 .014 .01 .022 .069 .031 .012 .018 RDF 29 Indox

- Cantaloupe, FTD, 46651501.d er doc max CT=100% totalz=0 0.027 0.247 0.13 .393 .088 .031 .05 .036 .05 .116 .018 .064 .197 .17 .23 .068 .022 .064 .035 .052 .124 .024 RDF 30 Indox

- Apricot, Nectarine, used Peach FTD, 46651505.der ToTALZ=0 doc max CT=100% RDF 31 Indox

- cranberry, FTD, 46651507.der, PHI=28

- 30 days doc max CT=100% totalz=0 .086 RDF 32 Indox

- Spinach FTD, 4648700 1.der used for rest of group 4A (100% CT assumption) doc max CT=100% totalz=0Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **26** of **41** .07 .26 .13 .03 .04 .1 .09 .3 .16 .19 .58 .07 .06 .29 .13 .04 .04 .3 .16 .2 .59 .07 .09 .09 .09 .09 .1 .1 .1 .1 .151 .099 .190 .13 .57 .146 .149 .11 .16 .11 .69 7.9 13 2.5 4.5 3.7 3.3 5.7 5.7 4.7 4.3 4.3 4.2 7.2 6.7 2.2 4.4

RDF 33 Indox

- potato ; tolerance, D276516 doc max % CT=2.5 totalz=39 0.01 RDF 16 Indoxacarb, garden beet r oot doc max CT=100% totalz=0 0.11 0.12 0.12 0.13 0.18 0.18 RDF 17 Indoxacarb, garden beet tops doc max CT=100% totalz=0 1.31 1.31 1.86 1.88 2.15 2.23Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **27** of **41** 0.18 0.19 0.21 0.22 3.01 3.28 3.70 3.96Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **28** of **41 Attachment**  **2 : Acute Food plus Water Residue Input File**  **and Result File**  Filename: C: \ Documents and Settings \ iencarna \ My Documents \ DEEM Version 3.16 \ Indoxacarb \ INDOXACARB_ACUTE.R08 Chemical: Indoxacarb RfD(Chronic): .02 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .12 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 04

- 30
- 2013/16:17:14 Program ver. 3.16, 03

- 08
- d Comment: EDWC 0.0593 ppm

----------------------------------------------------------------------------------- RDL indices and parameters for Monte Carlo Analysis: Index Dist Parameter #1 Param #2 Param #3 Comment # Code

----- ---- ------------ -------- -------- ------- 1 6 Indoxacarb
- 041207
- apple.rdf 2 6 indoxacarb
- Blueberry
- FTD.rdf 3 6 Indoxacarb
- 041207
- broccoli.rdf 4 6 Indoxacarb
- 041207
- Grp5A
- rest.rdf 5 6 Indoxacarb
- 041107
- cabbage
- WithoutWrapper.rdf 6 6 Indoxacarb
- 040907
- cherries.rdf 7 6 indoxacarb
- 040307
- MustrdGrn
- FTD.rdf 8 6 Indoxacarb
- 041107
- HeadLettuce
- NoWrapper.rdf 9 6 Indoxacarb
- 041707
- LeafLettuce.rdf 10 6 Indoxacarb
- 040907
- peach.rdf 11 6 Indoxacarb
- 041207
- pear.rdf 12 6 Indoxacarb
- 041507
- tomato.rdf 13 6 Indoxacarb
- 041507
- FruitgVeg.rdf 14 6 Indoxacarb
- 041707
- sweet - corn.rdf 15 6 Indoxacarb
- 041507
- Pepper.rdf 16 6 indoxacarb
- garden beet root
- FTD.rdf 17 6 indoxacarb
- garden beet top
- FTD.rdf 18 6 Indoxacarb
- blank3.rdf 19 6 Indoxacarb
- blank4.rdf 20 6 Indoxacarb
- blank5.rdf 21 6 Indoxacarb
- 041007
- mint.rdf 22 6 indo xacarb
- 040907
- spinach.rdf 23 6 Indoxacarb
- 040907
- plum.rdf 24 6 Indoxacarb
- 040907
- 3
- dayPHI
- UntrimdCelery.rdf 25 6 Indoxacarb
- 040907
- southern
- pea.rdf 26 6 indoxacarb
- 040307
- grapeFTD.rdf 27 6 Indoxacarb
- 041007.squash.rdf 28 6 Indoxacarb
- 041007
- cucumber.rdf 29 6 Indoxacarb
- 041007
- cantaloupe.rdf 30 6 Indoxacarb
- 040907
- Apricot
- Nectarine.rdf 31 6 Indoxacarb
- 041007
- cranberry.rdf 32 6 indoxacarb
- 042307
- Grp
- 4A
- rest.rdf 33 6 Indoxacarb
- 042307
- potato.rdf EPA Crop Commodity Name Def Res Adj.Factors RDLComment Code Grp (ppm) #1 #2 Pntr

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 0101050000 1AB Beet, garden, roots 0.300000 1.000 1.000 16 0101050001 1AB Beet, garden, roots
- babyfood 0.300000 1.000 1.000 16 0103015000 1CD Arrowroot, flour 0.010000 1.000 1.000 0103015001 1C D Arrowroot, flour
- babyfood 0.010000 1.000 1.000 0103017000 1CD Artichoke, Jerusalem 0.010000 1.000 1.000 0103082000 1CD Cassava 0.010000 1.000 1.000 0103082001 1CD Cassava
- ba byfood 0.010000 1.000 1.000 0103139000 1CD Dasheen, corm 0.010000 1.000 1.000 0103166000 1CD Ginger 0.010000 1.000 1.000 0103166001 1CD Ginger
- babyfood 0.010000 1.000 1.000 0103167000 1CD Ginger, dried 0.010000 1.000 1.000 0103296000 1C Potato, chips 0.000100 0.850 1.000 Blende Full comment: Blended, %CT unknown 0103297 000 1C Potato, dry (granules/ flakes) 0.000100 0.850 1.000 Blende Full comment: Blended 0103297001 1C Potato, dry (granules/ flakes)

- b 0.000100 0.850 1.000 BlendeIndoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **29** of **41** Full comment: Blended 0103298000 1C Potato, flour 0.000100 1.000 1.000 Blende Full comment: Blended 0103298001 1C Potato, flour
- babyfood 0.000100 1.000 1.000 Blende Full comment: Blended 0103299000 1C Potato, tuber, w/peel 0.010000 1.000 1.000 33 0103299001 1C Potato, tuber, w/peel

- babyfood 0.010000 1.000 1.000 33 0103300000 1C Potato, tuber, w/o peel 0.010000 1.000 1.000 33 0103300001 1C Potato, tuber, w/o peel

- babyfood 0.010000 1.000 1.000 33 0103366000 1CD Sweet potato 0.010000 1.000 1.000 0103366001 1CD Sweet potato
- babyfood 0.010000 1.000 1.000 0103371000 1CD Tanier, corm 0.010000 1.000 1.000 0103387000 1 CD Turmeric 0.010000 1.000 1.000 0103406000 1CD Yam, true 0.010000 1.000 1.000 0103407000 1CD Yam bean 0.010000 1.000 1.000 0200051000 2 Beet, gar den, tops 6.000000 1.000 1.000 17 0401005000 4A Amaranth, leafy 14.000000 1.000 1.000 32 0401018000 4A Arugula 14.000000 1.000 1.000 32 0401104000 4A Chrysanthemum, garland 14.000000 1.000 1.000 32 0401133000 4A Cress, garden 14.000000 1.000 1.000 32 0401134000 4A Cress, upland 14.000000 1.000 1.000 32 0401138000 4A Dandelion, leaves 1 4.000000 1.000 1.000 32 0401150000 4A Endive 14.000000 1.000 1.000 32 0401204000 4A Lettuce, head 14.000000 1.000 1.000 8 0401205000 4A Lettuce, leaf 14.000000 1. 000 1.000 9 0401248000 4A Parsley, leaves 14.000000 1.000 1.000 32 0401313000 4A Radicchio 14.000000 1.000 1.000 32 0401355000 4A Spinach 14.000000 1.000 1.000 2 2 0401355001 4A Spinach
- babyfood 14.000000 1.000 1.000 22 0402076000 4B Cardoon 14.000000 1.000 1.000 24 0402085000 4B Celery 14.000000 1.000 1.000 24 040208500 1 4B Celery
- babyfood 14.000000 1.000 1.000 24 0402086000 4B Celery, juice 14.000000 1.000 1.000 24 0402087000 4B Celtuce 14.000000 1.000 1.000 24 0402152000 4B Fennel , Florence 14.000000 1.000 1.000 24 0402322000 4B Rhubarb 14.000000 1.000 1.000 24 0402367000 4B Swiss chard 14.000000 1.000 1.000 24 0501061000 5A Broccoli 12.000000 1.000 1.000 3 0501061001 5A Broccoli
- babyfood 12.000000 1.000 1.000 3 0501062000 5A Broccoli, Chinese 12.000000 1.000 1.000 3 0501064000 5A Brussels sprouts 12.000000 1.000 1.000 4 0501069000 5A Cabbage 12.000000 1.000 1.000 5 0501071000 5A Cabbage, Chinese, napa 12.000000 1.000 1.000 4 0501072000 5A Cabbage, Chinese, mustard 12.000000 1.000 1.000 4 0501083000 5A Cauliflower 12.000000 1.000 1.000 4 0501196000 5A Kohlrabi 12.000000 1.000 1.000 4 0502063000 5B Broccoli raab 12.000000 1.000 1.000 7 0502070000 5B Cabbage, Chinese, bok choy 12.000000 1.000 1.000 7 0502117000 5B Collards 12.000000 1.000 1.000 7 0502194000 5B Kale 12.000000 1.000 1.000 7 050222 9000 5B Mustard greens 12.000000 1.000 1.000 7 0502318000 5B Rape greens 12.000000 1.000 1.000 7 0502389000 5B Turnip, greens 12.000000 1.000 1.000 7 0600347000 6 Soy bean, seed 0.002200 1.000 1.000 Blende Full comment: Blended 0600349000 6 Soybean, soy milk 0.002200 1.000 1.000 Blende Full comment: Blended 0600349001 6 Soybean, soy milk
- babyfood or in 0.002200 1.000 1.000 Blende Full comment: Blended 0600350000 6 Soybean, oil 0.002200 0.640 1.000 Blende Full comment: Blended 0600350001 6 Soybean, oil
- babyfood 0.002200 0.640 1.000 Blende Full comment: Blended 0601043000 6A Bean, snap, succulent 0.900000 1.000 1.000 0601043001 6A Bean, snap, succulent
- babyfood 0.900000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.900000 1.000 1.000 0602033000 6B Bean, cowpea, succulent 0.900000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.900000 1.000 1.000Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **30** of **41** 0603030000 6C Bean, black, seed 0.900000 1.000 1.00 0 0603032000 6C Bean, broad, seed 0.900000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.900000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.900000 1.000 1.000 06030 36000 6C Bean, kidney, seed 0.900000 1.000 1.000 0603038000 6C Bean, lima, seed 0.900000 1.000 1.000 0603039000 6C Bean, mung, seed 0.900000 1.000 1.000 0603040000 6C Be an, navy, seed 0.900000 1.000 1.000 0603041000 6C Bean, pink, seed 0.900000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.900000 1.000 1.000 0603098000 6C Chickpea, seed 0.900000 1.000 1.000 0603098001 6C Chickpea, seed
- babyfood 0.900000 1.000 1.000 0603099000 6C Chickpea, flour 0.900000 1.000 1.000 0603182000 6C Guar, seed 0.100000 1.000 1.000 0603182001 6C Guar, seed
- babyfood 0.100000 1.000 1.000 0603348000 6C Soybean, flour 0.002200 1.000 1.000 Blende Full comment: Blended 0603348001 6C Soybean, flour
- babyfood 0.002200 1.000 1.000 Blende Full comment: Blended 0801374000 8A Tomatillo 0.270000 1.000 1.000 0801375000 8A Tomato 0.500000 1.000 1.000 12 080137 5001 8A Tomato
- babyfood 0.500000 1.000 1.000 12 0801376000 8A Tomato, paste 0.108000 1.400 1.000 Blende Full comment: Blended 0801376001 8A Tomato, paste
- babyfood 0.108000 1.400 1.000 Blende Full comment: Blended 0801377000 8A Tomato, puree 0.108000 0.520 1.000 Blende Full comment: Blended 0801377001 8A Tomato, puree
- babyfood 0.108000 0.520 1.000 Blende Full co mment: Blended 0801378000 8A Tomato, dried 0.108000 14.300 1.000 Blende Full comment: Blended 0801378001 8A Tomato, dried
- babyfood 0.108000 14.300 1.000 Blende Full comment: Blended 0801379000 8A Tomato, juice 0.500000 0.520 1.000 12 0802148000 8BC Eggplant 0.270000 1.000 1.000 0802234000 8BC Okra 0.270000 1.000 1.000 0802270000 8B Pepper, bell 0.500000 1.000 1.000 15 0802270001 8B Pepper, bell
- babyfood 0.500000 1.000 1.000 15 0802271000 8B Pepper, bell, dried 0.020100 1.000 1.000 Blende Full comment: Blended 080227100 1 8B Pepper, bell, dried
- babyfood 0.020100 1.000 1.000 Blende Full comment: Blended 0802272000 8BC Pepper, nonbell 0.500000 1.000 1.000 15 0802272001 8BC Pepper, nonbell
- babyfood 0.500000 1.000 1. 000 15 0802273000 8BC Pepper, nonbell, dried 0.020100 1.000 1.000 Blende Full comment: Blended 0901075000 9A Cantaloupe 0.600000 1.000 1.000 29 0901187000 9A Honeydew melon 0 .600000 1.000 1.000 29 0901399000 9A Watermelon 0.600000 1.000 1.000 29 0901400000 9A Watermelon, juice 0.600000 1.000 1.000 29 0902021000 9B Balsam pear 0.600000 1.0 00 1.000 27 0902088000 9B Chayote, fruit 0.600000 1.000 1.000 27 0902102000 9B Chinese waxgourd 0.600000 1.000 1.000 27 0902135000 9B Cucumber 0.600000 1.000 1.000 28 0902308000 9B Pumpkin 0.600000 1.000 1.000 27 0902309000 9B Pumpkin, seed 0.600000 1.000 1.000 27 0902356000 9B Squash, summer 0.600000 1.000 1.000 27 0902356001 9B Squash, summer
- babyfood 0.600000 1.000 1.000 27 0902357000 9B Squash, winter 0.600000 1.000 1.000 27 0902357001 9B Squash, winter
- babyfood 0.600000 1.000 1.000 27 1100007000 11 Apple, fruit with peel 1.000000 1.000 1.000 1 1100008000 11 Apple, peeled fruit 1.000000 1.000 1.000 1 1100008001 11 Apple, peeled fruit
- babyfood 1.000000 1.000 1.000 1 1100009000 11 Apple, dried 0.074000 8.000 1.000 1100009001 11 Apple, dried
- babyfood 0.074000 8.000 1.000 1100010000 11 Apple, juice 1.000000 0.010 1.000 1 1100010001 11 Apple, juice
- babyfood 1.000000 0.010 1.000 1Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **31** of **41** 1100011000 11 Apple, sauce 1.000000 1.000 1.000 1 1100011001 11 Apple, sauce
- babyfood 1.000000 1.000 1.000 1 1100129000 11 Crabapple 1.000000 1.000 1.000 1 1100210000 11 Loquat 1.000000 1.000 1.000 1 1100266000 11 Pear 0.110000 1.000 1.000 11 1100266001 11 Pear
- babyfood 0.110000 1.000 1.000 11 1100267000 11 Pear, dried 0.002000 6.250 1.000 Blende Full comment: Blended 1100268000 11 Pear, juice 0.110000 0.010 1.000 11 1100268001 11 Pear, juice
- babyfood 0.110 000 0.010 1.000 11 1100310000 11 Quince 1.000000 1.000 1.000 1 1201090000 12A Cherry 0.900000 1.000 1.000 6 1201090001 12A Cherry
- babyfood 0.900000 1.000 1.000 6 1201091000 12A Cherry, juice 0.900000 1.500 1.000 6 1201091001 12A Cherry, juice
- babyfood 0.900000 1.500 1.000 6 1202012000 12B Apricot 0.900000 1.000 1.000 30 1 202012001 12B Apricot
- babyfood 0.900000 1.000 1.000 30 1202013000 12B Apricot, dried 0.155300 6.000 1.000 1202014000 12B Apricot, juice 0.900000 1.000 1.000 30 1202014001 12B Apricot, juice
- babyfood 0.900000 1.000 1.000 30 1202230000 12B Nectarine 0.900000 1.000 1.000 30 1202260000 12B Peach 0.900000 1.000 1.000 10 1202260001 12B Peach
- babyf ood 0.900000 1.000 1.000 10 1202261000 12B Peach, dried 0.003900 4.000 1.000 1202261001 12B Peach, dried
- babyfood 0.003900 4.000 1.000 1202262000 12B Peach, juice 0.900000 1.000 1.000 10 1202262001 12B Peach, juice
- babyfood 0.900000 1.000 1.000 10 1203285000 12C Plum 0.900000 1.000 1.000 23 1203285001 12C Plum
- babyfood 0. 900000 1.000 1.000 23 1203286000 12C Plum, prune, fresh 0.900000 1.000 1.000 23 1203286001 12C Plum, prune, fresh
- babyfood 0.900000 1.000 1.000 23 1203287000 12C Plum, prune, dried 0.900000 4.00 0 1.000 23 Partia Full comment: Partially blended 1203287001 12C Plum, prune, dried
- babyfood 0.900000 4.000 1.000 23 Partia Full comment: Partially blended 1203288000 12C Plum, prune, juice 0.900000 1.400 1.000 23 1203288001 12C Plum, prune, juice
- babyfood 0.900000 1.400 1.000 23 1302057000 13B Blueberry 1.500000 1.000 1.000 2 1302057001 13B Blueberry
- babyfood 1.500000 1.000 1.000 2 13021360 00 13B Currant 1.500000 1.000 1.000 2 1302137000 13B Currant, dried 1.500000 1.000 1.000 2 1302149000 13B Elderberry 1.500000 1.000 1.000 2 1302174000 13B Goose berry 3.000000 1.000 1.000 2 1302191000 13B Huckleberry 1.500000 1.000 1.000 2 1304175000 13D Grape 3.000000 1.000 1.000 26 1304176000 13D Grape, juice 3.000000 0.007 1.000 26 1304176001 13D Grape, juice
- babyfood 3.000000 0.007 1.000 26 1304179000 13D Grape, wine and sherry 3.000000 1.000 1.000 26 1307130000 13G Cranberry 1.000000 1.000 1.000 31 1307130001 13G Cranberry
- babyfood 1.000000 1.000 1.000 31 1307131000 13G Cranberry, dried 1.000000 1.000 1.000 31 1307132000 13G Cranberry, juice 1.000000 1.100 1.000 31 1307132001 13G Cranberry, juice
- babyfood 1.000000 1.100 1.000 31 1500127000 15 Corn, sweet 0.020000 1.000 1.000 14 1500127001 15 Corn, sweet
- babyfood 0.020000 1.000 1.00 0 14 2003128000 20C Cottonseed, oil 0.670000 0.040 1.000 Blende Full comment: Blended 2003128001 20C Cottonseed, oil
- babyfood 0.670000 0.040 1.000 Blende Full comment: Blended 3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat
- babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 3100046000 31 Beef, meat byproduc ts 0.030000 1.000 1.000 3100046001 31 Beef, meat byproducts
- babyfood 0.030000 1.000 1.000 3100047000 31 Beef, fat 1.500000 1.000 1.000 3100047001 31 Beef, fat
- babyfood 1.500000 1.000 1.000 3100048000 31 Beef, kidney 0.030000 1.000 1.000 3100049000 31 Beef, liver 0.030000 1.000 1.000Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **32** of **41** 3100049001 31 Beef, liver
- babyfood 0.030000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.030000 1.000 1.000 3200171000 32 Goat, fat 1.500000 1.000 1.000 3200172000 32 Goat, kidney 0.030000 1.000 1.000 3200173000 32 Goat, liver 0.030000 1.000 1.000 3300189000 33 Horse, meat 0.050000 1.000 1.000 340029 0000 34 Pork, meat 0.050000 1.000 1.000 3400290001 34 Pork, meat
- babyfood 0.050000 1.000 1.000 3400291000 34 Pork, skin 1.500000 1.000 1.000 3400292000 34 Por k, meat byproducts 0.030000 1.000 1.000 3400292001 34 Pork, meat byproducts
- babyfood 0.030000 1.000 1.000 3400293000 34 Pork, fat 1.500000 1.000 1.000 3400293001 34 Pork, fat
- babyfo od 1.500000 1.000 1.000 3400294000 34 Pork, kidney 0.030000 1.000 1.000 3400295000 34 Pork, liver 0.030000 1.000 1.000 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat
- babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.030000 1.000 1.000 3500341000 35 Sheep, fat 1.50000 0 1.000 1.000 3500341001 35 Sheep, fat
- babyfood 1.500000 1.000 1.000 3500342000 35 Sheep, kidney 0.030000 1.000 1.000 3500343000 35 Sheep, liver 0.030000 1.000 1. 000 3600222000 36 Milk, fat 2.430000 1.000 1.000 3600222001 36 Milk, fat
- baby food/infant formu 2.430000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.500000 1.000 1.000 360 0223001 36 Milk, nonfat solids
- baby food/in 0.500000 1.000 1.000 4000093000 40 Chicken, meat 0.045000 1.000 1.000 4000093001 40 Chicken, meat
- babyfood 0.045000 1.000 1.000 4000094000 40 Chicken, liver 0.052000 1.000 1.000 4000095000 40 Chicken, meat byproducts 0.052000 1.000 1.000 4000095001 40 Chicken, meat byproducts
- babyfoo 0.052000 1.000 1.000 4000096000 40 Chicken, fat 0.457000 1.000 1.000 4000096001 40 Chicken, fat
- babyfood 0.457000 1.000 1.000 4000097000 40 Chicken, skin 0.079000 1.000 1.000 4000097001 40 Chicken, skin
- babyfood 0.079000 1.000 1.000 5000382000 50 Turkey, meat 0.045000 1.000 1.000 5000382001 50 Turkey, meat
- babyfood 0.045000 1.000 1.000 5000383000 50 Turkey, liver 0.05 2000 1.000 1.000 5000383001 50 Turkey, liver
- babyfood 0.052000 1.000 1.000 5000384000 50 Turkey, meat byproducts 0.052000 1.000 1.000 5000384001 50 Turkey, meat byproducts
- babyfood 0.052000 1.000 1.000 5000385000 50 Turkey, fat 0.460000 1.000 1.000 5000385001 50 Turkey, fat
- babyfood 0.460000 1.000 1.000 5000386000 50 Turkey, skin 0.079000 1.000 1.000 5000386001 50 Turkey, skin
- babyfood 0.079000 1.000 1.000 6000301000 60 Poultry, other, meat 0.045000 1.000 1.000 6000302000 60 Poultry, other, liver 0.052000 1.000 1.000 6000303000 60 Poultry, other, meat byproducts 0.052000 1.000 1.000 6000304000 60 Poultry, other, fat 0.457000 1.000 1.000 6000305000 60 Poultry, other, skin 0.079000 1.000 1.000 7000145000 70 Egg, whole 0.119000 1.000 1.000 7000145001 70 Egg, whole
- babyfood 0.119000 1.000 1.000 7000146000 70 Egg, white 0.119000 1.000 1.000 7000146001 70 Egg, white (solids)
- bab yfood 0.119000 1.000 1.000 7000147000 70 Egg, yolk 0.119000 1.000 1.000 7000147001 70 Egg, yolk
- babyfood 0.119000 1.000 1.000 8601000000 86A Water, direct, all sources 0 .059260 1.000 1.000 8602000000 86B Water, indirect, all sources 0.059260 1.000 1.000 9500177000 O Grape, leaves 2.000000 1.000 1.000 26 9500178000 O Grape, raisin 6.000000 2.7 00 1.000 26 9500263000 O Peanut 0.000300 1.000 1.000 Blende Full comment: Blended 9500264000 O Peanut, butter 0.000300 1.890 1.000 Blende Full comment: Blended 9500265000 O Peanut, oil 0.000300 1.400 1.000 Blende Full comment: Blended 9500275000 O Peppermint 3.870000 1.000 1.000 21Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **33** of **41** 9500276000 O Peppermint, oil 3.870000 0.028 1.000 Blende Full comment: Blended 9500352000 O Spearmint 3.870000 1.000 1.000 21 9500353000 O Spearmint, oil 3.870000 0.028 1.000 Blende Full comment: Blended

US EPA Ver. 3.16, 03
- 08
- d DEEM - FCID ACUTE Analysis for INDOXACARB NHANES 2003
- 2008 2
- Day Residue file: INDOXACARB_ACUTE.R08 Adjustment factor #2 NOT used. Analysis Date: 04
- 30
- 2013/16:25: 21 Residue file dated: 04
- 30
- 2013/16:17:14 RAC/FF intake summed over 24 hours MC iterations = 1000; MC list in residue file; MC seed = 1000; RNG = MS VB Run Comment: "EDWC 0.0593 ppm"

===================================================================== ========== Summary calculations
-- per capita: 95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- - ------- ---------- -------- Total US Population: 0.009954 8.30 0.017531 14.61 0.032762 27.30 All Infants: 0.016632 13.86 0.023797 19.83 0.058294 48.58 Children 1
- 2: 0.021818 18.18 0.030424 25.35 0.054158 45.13 Children 3
- 5: 0.016529 13.77 0.026494 22.08 0.046841 39.03 Children 6
- 12: 0.010843 9.04 0.016818 14.02 0.035434 29.53 Y outh 13
- 19: 0.006731 5.61 0.010642 8.87 0.025623 21.35 Adults 20
- 49: 0.007453 6.21 0.012442 10.37 0.025109 20.92 Adults 50
- 99: 0.007340 6.12 0.013368 1 1.14 0.030965 25.80 Female 13
- 49: 0.007511 6.26 0.013145 10.95 0.026456 22.05Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **34** of **41 Attachment 3:**  **Chronic Risk Assessment Input File and Result File** 

Filename: C: \ Documents and Settings \ iencarna \ My Documents \ DEEM V ersion 3.16 \ Indoxacarb \ INDOXACARB_CHRONIC.R08 Chemical: Indoxacarb RfD(Chronic): .02 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .12 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 04

- 30
- 2013/16:16:25 Program ver. 3 .16, 03
- 08
- d Comment: EDWC 0.01848 ppm for chronic

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101050000 1AB Beet, garden, roots 0.160000 1.000 1.000 0101050001 1AB Beet, garden, roots
- babyfood 0.1600 00 1.000 1.000 0103015000 1CD Arrowroot, flour 0.010000 1.000 1.000 0103015001 1CD Arrowroot, flour
- babyfood 0.010000 1.000 1.000 0103017000 1CD Artichoke, Jerusalem 0.010000 1.000 1.000 01030 82000 1CD Cassava 0.010000 1.000 1.000 0103082001 1CD Cassava
- babyfood 0.010000 1.000 1.000 0103139000 1CD Dasheen, corm 0.010000 1.000 1.000 0103166000 1CD Ginger 0.010000 1.000 1.000 0103166001 1CD Ginger
- babyfood 0.010000 1.000 1.000 0103167000 1CD Ginger, dried 0.010000 1.000 1.000 0103296000 1C Potato, chips 0.00 4000 0.850 0.010 0103297000 1C Potato, dry (granules/ flakes) 0.004000 0.850 0.010 0103297001 1C Potato, dry (granules/ flakes)

- b 0.004000 0.850 0.010 0103298000 1C Potato, flour 0.004000 1.000 0.010 010 3298001 1C Potato, flour
- babyfood 0.004000 1.000 0.010 0103299000 1C Potato, tuber, w/peel 0.010000 1.000 0.010 0103299001 1C Potato, tuber, w/peel

- babyfood 0.010000 1.000 0.010 0103300000 1C Potato, tube r, w/o peel 0.010000 1.000 0.010 0103300001 1C Potato, tuber, w/o peel

- babyfood 0.010000 1.000 0.010 0103366000 1CD Sweet potato 0.010000 1.000 1.000 0103366001 1CD Sweet potato
- babyfood 0. 010000 1.000 1.000 0103371000 1CD Tanier, corm 0.010000 1.000 1.000 0103387000 1CD Turmeric 0.010000 1.000 1.000 0103406000 1CD Yam, true 0.010000 1.000 1.000 0 103407000 1CD Yam bean 0.010000 1.000 1.000 0200051000 2 Beet, garden, tops 2.470000 1.000 1.000 0401005000 4A Amaranth, leafy 5.270000 1.000 1.000 0401018000 4A Arugula 5.270000 1.000 1.000 0401104000 4A Chrysanthemum, garland 5.270000 1.000 1.000 0401133000 4A Cress, garden 5.270000 1.000 1.000 0401134000 4A Cress, upland 5.270000 1.000 1.000 0401138000 4A Dandelion, leaves 5.270000 1.000 1.000 0401150000 4A Endive 5.270000 1.000 1.000 0401204000 4A Lettuce, head 0.220000 1.000 0.100 0401205000 4A Lettuce, leaf 6.010000 1.000 0.100 0401248000 4A Parsley, leaves 5.270000 1.000 1.000 0401313000 4A Radicchio 5.270000 1.000 1.000 0401355000 4A Spinach 5.270000 1.000 0.025 0401355001 4A Spinach
- babyfood 5.270000 1.000 0.025 0402076000 4B Cardoon 1.930000 1.000 1.000 0402085000 4B Celery 1.930000 1.000 0.050 0402085001 4B Celery
- babyfood 1.930000 1.000 0.050 0402086000 4B Celery, juice 1.930000 1.000 0.050 0402087000 4B Celtuce 1.930000 1.000 1.000 0402152000 4B Fennel, Florence 1.930000 1.000 1.000 0402322000 4B Rhubarb 1.930000 1.000 1.000 0402367000 4B Swiss chard 1.930000 1.000 1.000 0501061000 5A Brocco li 0.648000 1.000 0.500 0501061001 5A Broccoli
- babyfood 0.648000 1.000 0.500 0501062000 5A Broccoli, Chinese 0.648000 1.000 1.000 0501064000 5A Brussels sprouts 0.648000 1.000 1.000Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **35** of **41** 0501069000 5A Cabbage 0.057700 1.000 0.250 0501071000 5A Cabbage, Chinese, napa 0.057700 1.000 1.000 0501072000 5A Cabbage, Chinese, mustard 0.057700 1.000 1.0 00 0501083000 5A Cauliflower 0.648000 1.000 0.400 0501196000 5A Kohlrabi 0.648000 1.000 1.000 0502063000 5B Broccoli raab 5.980000 1.000 1.000 0502070000 5B Cabb age, Chinese, bok choy 5.980000 1.000 1.000 0502117000 5B Collards 5.980000 1.000 1.000 0502194000 5B Kale 5.980000 1.000 1.000 0502229000 5B Mustard greens 5.980000 1.000 1.000 0502318000 5B Rape greens 5.980000 1.000 1.000 0502389000 5B Turnip, greens 5.980000 1.000 1.000 0600347000 6 Soybean, seed 0.088000 1.000 0 .010 0600349000 6 Soybean, soy milk 0.088000 1.000 0.010 0600349001 6 Soybean, soy milk
- babyfood or in 0.088000 1.000 0.010 0600350000 6 Soybean, oil 0.088000 0.640 0.010 0600350001 6 So ybean, oil
- babyfood 0.088000 0.640 0.010 0601043000 6A Bean, snap, succulent 0.180000 1.000 1.000 0601043001 6A Bean, snap, succulent
- babyfood 0.180000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.180000 1.000 1.000 0602033000 6B Bean, cowpea, succulent 0.180000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.180000 1.000 1.000 0603030000 6C Bean, black, seed 0.180000 1.000 1.000 0603032000 6C Bean, broad, seed 0.180000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.180000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.180000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.180000 1.000 1.000 0603038000 6C Bean, lima, seed 0.180000 1.000 1.000 0603039000 6C Bean, mung, seed 0.180000 1.000 1.000 0603040000 6C Bean, navy, seed 0.180000 1.000 1.000 0603041000 6C Bean, pink, seed 0.180000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.180000 1.000 1.000 0603098000 6C Chickpea, seed 0.180000 1.00 0 1.000 0603098001 6C Chickpea, seed
- babyfood 0.180000 1.000 1.000 0603099000 6C Chickpea, flour 0.180000 1.000 1.000 0603182000 6C Guar, seed 0.010000 1.000 1.000 0603182001 6C Guar, seed
- babyfood 0.010000 1.000 1.000 0603348000 6C Soybean, flour 0.088000 1.000 0.010 0603348001 6C Soybean, flour
- babyfood 0.088000 1.000 0.010 0801374000 8A Tomatillo 0.270000 1.000 1.000 0801375000 8A Tomato 0.270000 1.000 0.200 0801375001 8A Tomato
- babyfood 0.270000 1.000 0.200 0801376000 8A Tomato, paste 0.270000 1. 400 0.200 0801376001 8A Tomato, paste
- babyfood 0.270000 1.400 0.200 0801377000 8A Tomato, puree 0.270000 0.520 0.200 0801377001 8A Tomato, puree
- babyfood 0.270000 0.520 0.200 0801378000 8 A Tomato, dried 0.270000 14.300 0.200 0801378001 8A Tomato, dried
- babyfood 0.270000 14.300 0.200 0801379000 8A Tomato, juice 0.270000 0.520 0.200 0802148000 8BC Eggplant 0.270000 1.000 1.000 0802234000 8BC Okra 0.270000 1.000 1.000 0802270000 8B Pepper, bell 0.067000 1.000 0.150 0802270001 8B Pepper, bell
- babyfood 0.067000 1.000 0.150 0802271000 8B Pepper, bell, dried 0.067000 1.000 0.150 0802271001 8B Pepper, bell, dried
- babyfood 0.067000 1.000 0.150 0802272000 8BC Pepper, nonbell 0.067000 1.000 0.150 0802272001 8BC Pepper, nonbell
- babyfood 0.067000 1.000 0.150 0802273000 8BC Pepper, nonbell, dried 0.067000 1.000 0.150 0901075000 9A Cantaloupe 0.101600 1.000 1.000 0901187000 9A Honeydew melon 0.101600 1.000 1.000 0901399000 9A Watermelon 0.101600 1.000 1.000 0901400000 9A Watermelon, juice 0.101600 1.000 1.000 0902021000 9B Balsam pear 0.033100 1.000 1.000 0902088000 9B Chayote, fruit 0.033100 1.000 1.000 0902102000 9B Chinese waxgourd 0.033100 1.000 1.000 0902135000 9B Cucumber 0.023000 1.000 1.000 09023080 00 9B Pumpkin 0.033100 1.000 1.000 0902309000 9B Pumpkin, seed 0.033100 1.000 1.000Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **36** of **41** 0902356000 9B Squash, summer 0.033100 1.000 1.000 0902356001 9B Squash, summer
- ba byfood 0.033100 1.000 1.000 0902357000 9B Squash, winter 0.033100 1.000 1.000 0902357001 9B Squash, winter
- babyfood 0.033100 1.000 1.000 1100007000 11 Apple, fruit with peel 0.74000 0 1.000 0.050 1100008000 11 Apple, peeled fruit 0.740000 1.000 0.050 1100008001 11 Apple, peeled fruit
- babyfood 0.740000 1.000 0.050 1100009000 11 Apple, dried 0.740000 8.000 0.050 110000 9001 11 Apple, dried
- babyfood 0.740000 8.000 0.050 1100010000 11 Apple, juice 0.740000 1.300 0.050 1100010001 11 Apple, juice
- babyfood 0.740000 1.300 0.050 1100011000 11 Apple, sauce 0.740000 1.000 0.050 1100011001 11 Apple, sauce
- babyfood 0.740000 1.000 0.050 1100129000 11 Crabapple 0.740000 1.000 1.000 1100210000 11 Loquat 0.740 000 1.000 1.000 1100266000 11 Pear 0.080000 1.000 0.010 1100266001 11 Pear
- babyfood 0.080000 1.000 0.010 1100267000 11 Pear, dried 0.080000 6.250 0.010 1100 268000 11 Pear, juice 0.080000 0.010 0.010 1100268001 11 Pear, juice
- babyfood 0.080000 0.010 0.010 1100310000 11 Quince 0.740000 1.000 1.000 1201090000 12A Cherry 0.250000 1.000 0.010 1201090001 12A Cherry
- babyfood 0.250000 1.000 0.010 1201091000 12A Cherry, juice 0.250000 1.500 0.010 1201091001 12A Cherry, juice
- babyfood 0.2 50000 1.500 0.010 1202012000 12B Apricot 0.155000 1.000 1.000 1202012001 12B Apricot
- babyfood 0.155000 1.000 1.000 1202013000 12B Apricot, dried 0.155000 6.000 1.000 12 02014000 12B Apricot, juice 0.155000 1.000 1.000 1202014001 12B Apricot, juice
- babyfood 0.155000 1.000 1.000 1202230000 12B Nectarine 0.155300 1.000 1.000 1202260000 12B Peach 0.155000 1.000 0.025 1202260001 12B Peach
- babyfood 0.155000 1.000 0.025 1202261000 12B Peach, dried 0.155000 4.000 0.025 1202261001 12B Peach, dried
- babyfood 0 .155000 4.000 0.025 1202262000 12B Peach, juice 0.155000 1.000 0.025 1202262001 12B Peach, juice
- babyfood 0.155000 1.000 0.025 1203285000 12C Plum 0.045000 1.000 1.000 1203285001 12C Plum
- babyfood 0.045000 1.000 1.000 1203286000 12C Plum, prune, fresh 0.045000 1.000 1.000 1203286001 12C Plum, prune, fresh
- babyfood 0.045000 1.000 1.000 1203287000 12C Plum, pru ne, dried 0.045000 4.000 1.000 1203287001 12C Plum, prune, dried
- babyfood 0.045000 4.000 1.000 1203288000 12C Plum, prune, juice 0.045000 1.000 1.000 1203288001 12C Plum, prune, juice
- babyfood 0.045000 1.000 1.000 1302057000 13B Blueberry 0.570000 1.000 1.000 1302057001 13B Blueberry
- babyfood 0.570000 1.000 1.000 1302136000 13B Currant 0.570000 1.000 1.000 1302137000 13B Currant, dried 0.570000 1.000 1.000 1302149000 13B Elderberry 0.570000 1.000 1.000 1302174000 13B Gooseberry 0.570000 1.000 1.000 1302191000 13B Huckleb erry 0.570000 1.000 1.000 1304175000 13D Grape 0.503000 1.000 0.010 1304176000 13D Grape, juice 0.503000 0.007 0.010 1304176001 13D Grape, juice
- babyfood 0.503000 0.007 0.010 1304179000 13D Grape, wine and sherry 0.503000 1.000 1.000 1307130000 13G Cranberry 0.216000 1.000 1.000 1307130001 13G Cranberry
- babyfood 0.216000 1.000 1.00 0 1307131000 13G Cranberry, dried 0.216000 1.000 1.000 1307132000 13G Cranberry, juice 0.216000 1.100 1.000 1307132001 13G Cranberry, juice
- babyfood 0.216000 1.100 1.000 1500127000 15 Corn, sweet 0.008000 1.000 0.025 1500127001 15 Corn, sweet
- babyfood 0.008000 1.000 0.025 2003128000 20C Cottonseed, oil 0.670000 0.040 1.000 2003128001 20C Cottonseed, oil
- babyfood 0.670000 0.040 1.000 3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat
- babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dried 0.050000 1.920 1. 000Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **37** of **41** 3100046000 31 Beef, meat byproducts 0.030000 1.000 1.000 3100046001 31 Beef, meat byproducts
- babyfood 0.030000 1.000 1.000 3100047000 31 Beef, fat 0.016000 1.000 1.000 3100047001 31 Bee f, fat
- babyfood 0.016000 1.000 1.000 3100048000 31 Beef, kidney 0.030000 1.000 1.000 3100049000 31 Beef, liver 0.030000 1.000 1.000 3100049001 31 Beef, liver
- babyfood 0.030000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.030000 1.000 1.000 3200171000 32 Goat, fat 0.016000 1.000 1.000 3200172000 32 Goat, kidney 0.030000 1.000 1.000 3200173000 32 Goat, liver 0.030000 1.000 1.000 3300189000 33 Horse, meat 0.050000 1.000 1.000 3400290000 34 P ork, meat 0.050000 1.000 1.000 3400290001 34 Pork, meat
- babyfood 0.050000 1.000 1.000 3400291000 34 Pork, skin 0.016000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.030000 1.000 1.000 3400292001 34 Pork, meat byproducts
- babyfood 0.030000 1.000 1.000 3400293000 34 Pork, fat 0.016000 1.000 1.000 3400293001 34 Pork, fat
- babyfood 0.016000 1.000 1.000 3400294000 34 Pork, kidney 0.030000 1.000 1.000 3400295000 34 Pork, liver 0.030000 1.000 1.000 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat
- babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.030000 1.000 1.000 3500341000 35 Sheep, fat 0.016000 1.000 1.000 3500341001 35 Sheep, fat
- babyfood 0.016000 1.000 1.000 3500342000 35 Sheep, kidney 0.030000 1.000 1.000 3500343000 35 Sheep, liver 0.030000 1.000 1.000 3600222000 36 Milk, fat 0.026000 1.0 00 1.000 3600222001 36 Milk, fat
- baby food/infant formu 0.026000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.005200 1.000 1.000 3600223001 36 Milk, nonfat solids
- baby food/in 0.005200 1.000 1.000 4000093000 40 Chicken, meat 0.045000 1.000 1.000 4000093001 40 Chicken, meat
- babyfood 0.045000 1.000 1.000 4000094000 40 Chicken, liver 0.052000 1.000 1.000 4000095000 40 Chicken, meat byproduc ts 0.052000 1.000 1.000 4000095001 40 Chicken, meat byproducts
- babyfoo 0.052000 1.000 1.000 4000096000 40 Chicken, fat 0.457000 1.000 1.000 4000096001 40 Chicken, fat
- babyfood 0.457000 1 .000 1.000 4000097000 40 Chicken, skin 0.079000 1.000 1.000 4000097001 40 Chicken, skin
- babyfood 0.079000 1.000 1.000 5000382000 50 Turkey, meat 0.045000 1.000 1.000 5000382001 50 Turkey, meat
- babyfood 0.045000 1.000 1.000 5000383000 50 Turkey, liver 0.052000 1.000 1.000 5000383001 50 Turkey, liver
- babyfood 0.052000 1.000 1.000 5000384000 50 Turkey, meat byprodu cts 0.052000 1.000 1.000 5000384001 50 Turkey, meat byproducts
- babyfood 0.052000 1.000 1.000 5000385000 50 Turkey, fat 0.457000 1.000 1.000 5000385001 50 Turkey, fat
- babyfood 0.457000 1.000 1.000 5000386000 50 Turkey, skin 0.079000 1.000 1.000 5000386001 50 Turkey, skin
- babyfood 0.079000 1.000 1.000 6000301000 60 Poultry, other, meat 0.045000 1.000 1.000 600030200 0 60 Poultry, other, liver 0.052000 1.000 1.000 6000303000 60 Poultry, other, meat byproducts 0.052000 1.000 1.000 6000304000 60 Poultry, other, fat 0.457000 1.000 1.000 6000305000 60 Poultry, other, sk in 0.079000 1.000 1.000 7000145000 70 Egg, whole 0.119000 1.000 1.000 7000145001 70 Egg, whole
- babyfood 0.119000 1.000 1.000 7000146000 70 Egg, white 0.119000 1.000 1.000 7000146001 70 Egg, white (solids)
- babyfood 0.119000 1.000 1.000 7000147000 70 Egg, yolk 0.119000 1.000 1.000 7000147001 70 Egg, yolk
- babyfood 0.119000 1.000 1.000 8601000 000 86A Water, direct, all sources 0.018480 1.000 1.000 ave. 1

Full comment: ave. 1 in 10 yr, cranberry scenario 8602000000 86B Water, indirect, all sources 0.018480 1.000 1.000 ave. 1

Full comment: ave. 1 in 10 yr, cranberry scenario 9500177000 O Grape, leaves 0.503000 1.000 1.000Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **38** of **41** 9500178000 O Grape, raisin 0.503000 2.700 1.000 9500263000 O Peanut 0.003000 1.000 0.025 9500264000 O Peanut, butter 0.003000 1.890 0.025 9500265000 O Peanut, oil 0.003000 1.400 0.025 9500275000 O Peppermint 3.870000 1.000 1.000 9500276000 O Pepperm int, oil 3.870000 0.028 1.000 9500352000 O Spearmint 3.870000 1.000 1.000 9500353000 O Spearmint, oil 3.870000 0.028 1.000

US EPA Ver. 3.16, 03
- 08
- d DEEM - FCID Chronic analysis for INDOXACARB NHANES 2003
- 2008 2
- day Residue file name: C: \ Documents and Settings \ iencarna \ My Documents \ DEEM Version 3.16 \ Indoxacarb \ INDOXACARB_CHRONIC.R08 Adjustment factor #2 used. Analysis Date 04
- 30
- 2013/16:31:57 Residue file dated: 04

- 30
- 2013/16:16:25 Reference dose (RfD, Chronic) = .02 mg/kg bw/day COMMENT 1: EDWC 0.01848 ppm for chronic

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

------------------------------------------------------------------------------- Tota l Exposure

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

-------------- ------------------------ ------------- ---------------- Total US Population 0.001133 5.7% Hispanic 0.000991 5.0% Non - Hisp
- White 0.001112 5.6% Non - Hisp
- Black 0.001346 6.7% Non - Hisp
- Other 0.001276 6.4% Nursing Infants 0.000814 4.1% Non - Nursing Infants 0.002200 11.0% Female 13+ PREG 0.000951 4.8% Children 1
- 6 0.001967 9.8% Children 7
- 12 0.001034 5.2% Male 13
- 19 0.000748 3.7% Female 13
- 19/NP 0.000738 3.7% Male 20+ 0.001014 5.1 % Female 20+/NP 0.001165 5.8% Seniors 55+ 0.001149 5.7% All Infants 0.001772 8.9% Female 13
- 50 0.001038 5.2% Children 1
- 2 0.002381 11.9% Children 3
- 5 0.001818 9.1% Children 6
- 12 0.001105 5.5% Youth 13
- 19 0.000743 3.7% Adults 20
- 49 0.001036 5.2% Adults 50
- 99 0.001165 5.8% Female 13
- 49 0.001037 5.2%

-------------------------------------------------------------------------------Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **39** of **41 Attachment**  **4 :**  **Screening Level Estimates of Agricultural Uses of Indoxacarb (067710), October 12, 2012,**  **Reporting Years: 2 004**  **- 2011**  **Percent Crop Treated**

**Crop Lbs. A.I.**  **Avg. Max.**  **1** Alfalfa 10,000 <1 <2.5 

### 2 Apples 2,000 5 10 

### 3 Broccoli 5,000 50 70 

### 4 Brussels Sprout* <500 NC NC 

### 5 Cabbage 2,000 25 35 

### 6 Cantaloupes <500 5 10 

### 7 Cauliflower 1,000 40 60 

### 8 Celery <500 5 5 

### 9 Cherries <500 <1 <2.5 

### 10 Cotton 10,000 <1 <2.5 

### 11 Cucumbers <500 <1 <2.5 

### 12 Grapes <500 <1 <2.5 

### 13 Lettuce 4,0 00 10 40 

### 14 Nectarines 1,000 15 15 

### 15 Peaches <500 <2.5 <2.5 

### 16 Peanuts 3,000 <2.5 10 

### 17 Pears <500 <1 <2.5 

### 18 Peppers 1,000 15 30 

### 19 Plums/Prunes <500 <2.5 5 

### 20 Potatoes 1,000 <1 <2.5 

### 21 Pumpkins <500 <2.5 <2.5 

### 22 Soybeans 4,000 <1 <2.5 

### 23 Spinach <500 <2.5 5 

### 24 Squash <500 <2.5 5 

### 25 Sweet Corn 1,000 <2.5 10 

### 26 Tomatoes 9,000 20 40 

### 27 Watermelons <500 5 10 All numbers are rounded. <500: indicates less than 500 pounds of active ingredient. <2.5: indicates less than 2.5 percent of crop is treated. <1: indicates less than 1 percent of crop is treated. * California data only.Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **40** of **41** NC: not cal culated, only pounds a.i. available. SLUA data sources include: USDA

-NASS (United States Department of Agriculture's National Agricultural Statistics Service) Private Pesticide Market Research California DPR (Department of Pesticide Regulation) Thes e results reflect amalgamated data developed by the Agency and are releasable to the public.Indoxacarb Dietary Exposure Assessment DP Bar code: 408983



### Page **41** of **41 Attachment #5:**  **Highest/average residues of indoxacarb in feedstuff commodities 6**  

### 1. Wet apple pomace (CC) 1 

### Processing factor = 2.6x; Highest field trial residu e adjusted for application rate = 0.74 ppm Average residue in wet apple pomace = **1.9 ppm** 2. Cotton undelinted seed (PC) 1 

### Highest field trial residue adjusted for application rate = **1.3 ppm** 3. Cotton gin by

products (R) 1 

### Highest field trial residue adj usted for application rate = **6.7 ppm** * a bridging study

showed higher residues than these but were not considered because the plants were not allowed to dry

before ginning; therefore, they had more leaves than normally and resulted in higher residues. 4. Sweet Corn stover (R) 1 

### Highest field trial residue adjusted for application rate = **13.4 ppm** 5. Sweet Corn forage (R) 1 

### Highest field trial residue adjusted for application rate = **8.7 ppm** 6. Peanut Hay

(R) 2 

### Highest / Average field trial residue = 18 ppm / **7.8 ppm** 7. Alfalfa forage (R) 3 

### Highest / Average field trial residue = 9.0 ppm / **4.8 ppm** 8. Alfalfa hay

(R) 3 

### Highest / Average field trial residue = 39 ppm / **15 ppm** 9. Soy bean seed (PC) 3 

### Average field trial = **0.088 ppm** 10. Soy bean hulls (R) 3,4 

### Processing Factor4 

### = 8.2x; Average field trial of soy bean seed 3 

### = 0.088 ppm Average residue in soy

bean hulls = **0.72 ppm** 11. Cowpea, foliage (R) 5 

### Highest / Average field trial residue = 32.1 ppm / **12.6 ppm** 12. Cowpea, hay

(R) 5 

### Highest / Average field t

rial residue = 92 ppm / **36 ppm** (Estimated from foliage data and % DM, * 86 / 30)



### _____ _____ _____________________________ ______________________________ 1 Sarah J. Levy; 19

- JAN

- 2000; DP Barcodes: D244253. 2 Sarah J. Levy; 7

- JAN

- 2005; DP Barcode 301655. 3 Sarah J. Levy; 30

- MAY

- 2002; DP Barcode: D276516. 4 MRID 45384305; Devine, T.; 2000. 5 Ideliz Negron

- Encarnacion; DP Barcode: D408982. 6 Residue values in bold were used for dietary burden calculations to support the chronic dietary assessment.