Document ID: EPA-HQ-OPP-2012-0420-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-12-27T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460      

	OFFICE OF CHEMICAL SAFETY AND

                                                                        
                   POLLUTION PREVENTION

	

MEMORANDUM

DATE:  	May 1, 2013

SUBJECT:	Indoxacarb Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessment for the Section 3
Registration Action on Dry Beans, Succulent Beans, Small Fruit Vine
Climbing Subgroup (except kiwifruit) 13-07F and Low Growing Berry
Subgroup (except strawberry) 13-07H. 

PC Code: 067710	DP Barcode:   D408983

Decision No.: 464583	Registration No.: 352-597

Petition No.: 2E8029	Regulatory Action: Section 3

Risk Assessment Type: Single Chemical /Aggregate	Case No.: NA

TXR No.: NA	CAS No.: 173584-44-6

MRID No.: NA	40 CFR:180.564

REVIEWER:	Ideliz Negrón-Encarnación, Ph.D., Chemist

		Risk Assessment Branch V

		Health Effects Division (7509P)

   

THROUGH:	Douglas Dotson, Ph.D., Chemist

				Kristin Rury, Chemist

	Dietary Exposure Science Advisory Council (DESAC)

TO:		Danette Drew, Senior Chemist

		Risk Assessment Branch V

		Health Effects Division (7509P)

			and

		Barbara Madden, Team Leader

		Risk Integration Minor Use, and Emergency Response Branch

		Registration Division (7505P)

Executive Summary

Acute and chronic dietary risk assessments for indoxacarb 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 from 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; D360559) 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 Section 3 registrations on dry beans, succulent beans,
Small fruit vine climbing subgroup (except kiwifruit) 13-07F and Low
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 proposed 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 proposed 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, D338731) following the guidance provided 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),
soybean (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 water 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 99.9th percentile of exposure is estimated to be 0.032762
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 (< 1 year old), with an estimated
exposure at the 99.9th percentile of 0.058294 mg/kg/day, equivalent to
49% of the aPAD.  

Estimated chronic dietary exposure to indoxacarb from food and drinking
water is below HED’s level of concern (i.e. < 100% cPAD).  Combined
dietary exposure from food and drinking water is estimated at 0.001133
mg/kg/day for the general U.S. population (5.7% of the chronic
population-adjusted dose (cPAD) and 0.002381 mg/kg/day (12% of the 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 chronic 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 equivalent to the point of departure (POD, NOAEL,
LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when
estimated dietary risk exceeds 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 Information 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

Indoxacarb 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 + its 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(
Insecticide, EPA Reg. No. 352-597) and a 1.25 lb/gal (15%) suspension
concentrate (SC) formulation (DuPont Steward® Insecticide, 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 (insecticidally inactive; IN-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 livestock
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;
D263986).  Indoxacarb 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 poultry commodities will include indoxacarb and
its R-enantiomer.  The residues of concern for risk assessment in milk
will also include the metabolite IN-MP819; and in poultry the
metabolites IN-JT333, IN-JU873, IN-KB687, IN-KG433, IN-KT319,
5-HO-IN-JT333, and 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 byproducts 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 byproducts (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 byproducts
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, meat
byproducts (0.03 ppm); Horse, fat (1.5 ppm); Horse, meat (0.05 ppm);
Horse, meat byproducts (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 byproducts (0.03 ppm); Soybean, hulls (4.0 ppm); Soybean,
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).   

DuPont has proposed tolerances for indoxacarb on dry beans and succulent
beans.  In addition, the Interregional Research Project No. 4 (IR-4)
proposes tolerances for Small fruit vine climbing subgroup (except
kiwifruit) 13-07F and Low 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-2013).

Table 1.  Tolerance Summary for Indoxacarb.

Commodity	Established/Proposed Tolerance (ppm)	HED-Recommended Tolerance
(ppm)	Comments (correct commodity definition)

Bean, dry, seed	0.07	0.2

	Pea, southern, seed	0.1	Remove

	Bean, succulent	0.64	0.9

	Bean, forage	37	50	Cowpea, forage

Cowpea, 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	Remove

	

Residue Data used for the 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 registered 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 corrected
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), soybean (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:

For non-blended and partially blended commodities:  Tolerance level
residues or the highest residue from the field trial data was used. 
Alternatively, a residue-distribution file (RDF) was constructed using
the entire distribution of field trial residue values.  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 was 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 commodities:  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 calculate the secondary residues in those tissues (see
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 Estimates Used in the Acute and Chronic
Dietary Analyses

Commodity	Classification	Ave.

% CT	Max

% CT	Source of Data	# of FTD	# of zeroes in RDF	sum (FTD)	mean of RDF or
FTD1	PF	Acute Value	Chronic

Value

apple juice	PB	5	10	highest FTD (DP#:  244253)	1	9	0.74	0.074	0.01	rdf x
PF	0.74 x fCT x PF

apples	NB	5	10	highest FTD (DP#: 244253)	1	9	0.74	0.074

rdf	0.74 x fCT

apples, dried	B	5	10	highest FTD (DP#: 244253)	1	9	0.74	0.074	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 Garden Roots	NB/PB	100	100	FTD

(DP# 351087)	10	0	1.64	0.16

rdf	0.16

Beet Garden Tops	PB	100	100	FTD

(DP# 351087)	10	0	24.69	2.47

rdf	2.47

Subgroup (13B)	PB	100	100	FTD

(DP# 351087)	26	0	14.8	0.57

rdf	0.57

Broccoli	NB	50	70	FTD 

(DP#: 244253)	20	8	12.95	0.4625

rdf	0.648 x fCT

Cabbage

(no wrapper)	NB	25	35	FTD 

(DP#: 244253)	24	40	1.27	0.0205

rdf	0.0577 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 FTD (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	0.2160

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	0.023

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

Grape 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

Lettuce head, no wrapper	NB	10	35

18	33	3.97	0.0778

rdf	0.22 x fCT

Lettuce, leaf	NB	10	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	0.08 x fCT x PF

Pepper (bell or non-bell)	PB	15	30	highest FTD (DP#: 244253)	30	70	1.005
0.0201

rdf	0.067

Pepper, dried	B	15	30	highest FTD (DP#: 244253)	30	70	1.005	0.0201

0.0201	0.067

Pepper, dry (bell or non-bell)	B	15	30	highest FTD (DP#: 244253)	15	70
1.005	0.0201

0.0201	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	Tolerance

tolerance	tolerance

Pork, fat	NB	100

Tolerance (a) /Anticip Res (c)

tolerance	0.016

Potato	NB	1	2.5	FTD/Tolerance	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
0.004 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	0.016

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	5.27

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	50	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	0.0331

Tomatoes	PB	20	40	highest FTD (DP#: 244253)	25	37	6.75	0.108

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 applicable

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 assessment further refinement was performed to
support the aggregate risk assessment (food and residential).

Bean, guar seed:  The tolerance 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 were used
as a point estimate 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
(PHIs) (celery at 7-, 14-, and 21-day PHIs while spinach at 3-, 7-, and
14-day PHIs).  The proposed label for leafy petiole vegetables (celery
is in subgroup 4B) 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 days.  However,
HED used the trimmed celery residue data to estimate untrimmed celery
residues as follows:  Indoxacarb residue concentrations in trimmed and
untrimmed celery were compared for 0-day, 7-day, and 14-day PHI samples.
 Based on this comparison, trimmed to untrimmed ratios were determined
to be 2.32 for the 0-day PHI samples, 3.0 for the 7-day PHI samples and
2.3 for the 14-day PHI samples.  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
trimmed 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 PHI celery FTD were multiplied
by 2.5 and used in an RDF
(Indoxacarb-040907-3-dayPHI-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
and 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).  For 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-Jan-2000, DP#: 244253 and 18-Feb-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 cranberry 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.

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 pepper, and tomatoes (S. Levy, 19-Jan-2000, 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; these 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 for 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 were 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, grape 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
used 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 for dried apple.  

Pear, pear juice, dried pear:  The highest FTD for pear which were
adjusted for rate of 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.

Peanut, peanut butter, peanut oil:  All are considered blended
commodities.  The highest FTD for peanut (0.003 ppm) with % CT were used
to derive a point estimate for acute.  For 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 soybean food forms are blended, the average FTD
(0.088 ppm) (S. Levy, 30-MAY-2002; DP#: 276516) were used as a point
estimate in conjunction with PF (0.64x for soybean 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-May-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).

Table 3.  Calculation of Poultry Dietary Burden.

Feedstuff	%DM	Classification	Tolerance	% In Diet	Dietary Burden

Corn, grain	

NA	CC4	0	70	0

Wheat, grain

CC	0	5	0

Soybean, meal1

PC5	0.8	15	0.12

Cottonseed, meal2

PC	2.0	5	0.10

Alfalfa, meal3

PC	50	5	2.50

Total

100	2.72

1   Based on soybean seed tolerance

2   Based on undelinted cottonseed tolerance

3   Based on alfalfa hay tolerance

4   CC = 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 value in
poultry liver tissue was used for meat by-product tissues. Refer to M.
Sahafeyan (DP # 339398; 23-May-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.  

In order 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
dietary 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 reported 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 Assessment of Indoxacarb.  

Feedstuff	%DM	Classification1	Highest/ Average Residue2	% In Diet
Dietary Burden	%Crop Treated	Refined Dietary Burden

Apples, Pomace, wet	40	CC	1.9	10	0.48	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. 

  

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
(D276518, 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 whole milk is 0.00104 ppm.  Due to high
lipophilicity 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., 0.00104 / 4%*100,
assuming milk 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 milk from the
dose-residue chart is 0.000229 ppm; therefore, considering the residues
of concern the expected residue is 0.00042 ppm (i.e., 0.000229*1.8). 
With the assumption that the residues are concentrated in non-fat solids
of the skim milk (~ 8% of the milk w/w), the estimated residues in
non-fat solids is 0.0052 ppm (i.e., 0.00042 / 8%*100).  No residues are
expected in milk water and lactose.  Refer to M. Sahafeyan (DP # 339398;
23-May-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 increase 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 ruminant 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 LOD) in 292 samples of adipose beef tissue.

Table 5.  Residues of indoxacarb in fat from the feeding study with
ruminants (D244253, S. Levy, 01/19/2000)

Dose (ppm)	Residue of R- and S- enantiomers (ppm)

7.5	0.52

22.5	0.39

75	0.42

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%; peaches:
2.5%; peanuts: 10%; pears: 2.5%; potatoes: 2.5%; soybeans: 2.5%;
spinach: 5%; sweet corn:  10%; tomatoes: 40%.  The following average
percent crop treated estimates were used in the chronic dietary risk
assessments for the following crops that are currently 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%; soybeans: 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 II 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 ™ Avaunt®,
EPA Reg. No. 352-597 and DuPont ™ 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 (IN-JT333, IN-KG4333, IN- KT413, IN-ML437-0H) for the drinking
water assessment.    

The recommended estimated drinking water concentrations (EDWCs) for the
human health risk 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 beans 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.  Recommended Estimated Drinking Water Concentrations (EDWCs)1
for Surface Water and Ground Water 

Drinking Water Source	Model

Scenario	Method2	Maximum 

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 Water	Provisional Cranberry Model

Cranberry	PCM	2 app @ 0.11 lb a.i./acre	59.26	18.48	18.48

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 adjusted 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
include 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
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V.   DEEM-FCID™ Program and Consumption Information

Indoxacarb 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 incorporates
2003 - 2008 consumption data from USDA’s NHANES/WWEIA.  The data are
based on the reported consumption of more than 20,000 individuals over
two non-consecutive survey days.  Foods “as consumed” (e.g., apple
pie) are linked to EPA-defined food commodities (e.g., apples, peeled
fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or
N/S, baked) using publicly available recipe translation files developed
jointly by USDA/ARS and EPA.  For chronic exposure assessment,
consumption data are averaged for the entire U.S. population and within
population subgroups.  However, for acute exposure assessment,
consumption data are retained as individual consumption events.  Based
on analysis of the 2003-2008 WWEIA consumption data, which took into
account dietary patterns and survey respondents, HED concluded that it
is most appropriate to report risk for the following population
subgroups: the general U.S. population, all infants (<1 year old),
children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49,
females 13-49, and adults 50-99 years old.

For a chronic dietary exposure assessment, an estimate of the residue
level in each food or food-form (e.g., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food 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 an individual-by-individual basis.  The reported
consumption amounts of each food item can be multiplied by a residue
point estimate and summed to obtain a total daily pesticide exposure for
a deterministic exposure assessment, or “matched” in multiple random
pairings with residue values and then summed in a 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/food 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.

VI.   Toxicological Information

Table 6 below summarizes the HED decisions on endpoints as related to
the dietary risk assessment as adapted from the Human Health Risk
Assessment (D. Drew, D402099, In Progress).

Table 6.  Summary of Toxicological Doses and Endpoints for Indoxacarb
for Use in Dietary Exposure Assessment1.

Exposure

Scenario	Dose 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 identified 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

	UFA= 10x

UFH=10x

FQPA SF = 1x

aPAD = 

= 0.12 mg/kg	Acute oral rat neurotoxicity study.

LOAEL = 50 mg/kg based on decreased body weight and body-weight gain in
females (MP062)

Chronic Dietary

all populations	NOAEL= 2.0 mg/kg/day

UF = 100

Chronic RfD = 0.02 mg/kg/day

	UFA= 10x

UFH=10x

FQPA SF = 1x 

cPAD = 

= 0.02 mg/kg/day	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-weight gain,
food consumption and food efficiency; decreased hematocrit, hemoglobin
and red blood cells only at 6 months.

Cancer (oral, dermal,inhalation)	“Not likely” to be carcinogenic to
humans since no 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 extrapolation to determine risk associated with lower environmentally
relevant human exposures.  NOAEL = no observed adverse effect level. 
LOAEL = lowest observed adverse effect level.  UF = uncertainty factor. 
UFA = extrapolation from animal to human (interspecies).  UFH =
potential variation in sensitivity among members of the human population
(intraspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  FQPA SF =
FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c =
chronic).  RfD = reference dose.   N/A = not applicable.

, 

VI.   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-FCID™ 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 99.9th
percentile of exposure is estimated to be 0.032762 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 99.9th percentile of
0.058294 mg/kg/day, equivalent to 49% of the aPAD.

Table 7.  Summary of Acute Dietary (Food + Drinking Water) Exposure and
Risk for Indoxacarb

Population Subgroup	aPAD (mg/kg/day)	95th Percentile	99th Percentile
99.9th Percentile

Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% aPAD	Exposure
(mg/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  	20	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 old

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	11	0.026456	22

The population subgroup with the highest estimated acute dietary (food +
drinking water) exposure and risk is indicated by bold text.

Chronic Dietary Exposure Results

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 0.001133 mg/kg/day for the
general U.S. population (5.7% of the cPAD) and 0.002381 mg/kg/day (12%
of the cPAD) for children, 1 to 2 years old, the population subgroup
with the highest estimated chronic dietary exposure to indoxacarb.

Table 8.  Summary of Chronic Dietary (Food + Drinking Water) Exposure
and Risk for Indoxacarb.

Population Subgroup	cPAD (mg/kg/day)	Exposure (mg/kg/day)	% cPAD

General U.S. Population	0.02	0.001133	5.7

All Infants (< 1 year old)

0.001772            	8.9

Children 1-2 years old

0.002381            	12

Children 3-5 years old

0.001818            	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

0.001165             	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 assessment 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 (mg/kg/day)	% aPAD*	Dietary Exposure

(mg/kg/day)	% cPAD*	Dietary Exposure

(mg/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	0.001818	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	0.001037	5.2

*The 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)

VIII.   Characterization of Inputs and Outputs

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 field
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. 

It is 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; D360559, 18-Feb-2009 for acute and D364939, 13-May-2009 for
chronic) was based on surveys conducted from 1994-1996 and 1998
(USDA’s Continuing Surveys 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 level 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 Food plus Water Residue Input file and Acute Results file.

Chronic Food plus Water Residue Input file and Chronic Results file.

Percent Crop Treated Memo from BEAD.

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, Blueberry 

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

Indoxacarb-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

0.94

0.26

0.52

0.36

0.49

0.23

0.26

0.38

0.54	RDF 4

Indoxacarb-subgroup 5A, Broccoli FTD,  

doc 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

0.54

RDF 5

Indoxacarb-Cabbage without Wrapper Leaves

doc Max %CT=35%

ToTALZ=44

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

9.4

RDF 8

Indoxacarb - Head Lettuce w/o wrapper 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=100%

0.27

RDF 14

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

ToTALZ=9

doc max %CT=10

0.008	RDF 15

Indox-pepper(bell or non-bell), FTD, D244253

doc highest FTD used (adjusted for exaggeration)

doc max CT=30%

ToTALZ=70

30,0.067	RDF 18-20 blank

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

3.25

3

1.075

1.375

1.9

1.325

1.05

1.175

4.75

4	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

.0320	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

0.105

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

.084

.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.der

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%

.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 31

Indox-cranberry, FTD, 46651507.der, PHI=28-30 days

doc max CT=100%

totalz=0

.086

.151

.099

.190

.13

.57

.146

.149

.11

.16

.11

.69	RDF 32

Indox-Spinach FTD, 46487001.der used for rest of group 4A (100% CT
assumption)

doc max CT=100%

totalz=0

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 root

doc max CT=100%

totalz=0

0.11

0.12

0.12

0.13

0.18

0.18

0.18

0.19

0.21

0.22

	RDF 17

Indoxacarb, garden beet tops 

doc max CT=100%

totalz=0

1.31

1.31

1.86

1.88

2.15

2.23

3.01

3.28

3.70

3.96

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   indoxacarb-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 1CD  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-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                      0.000100   0.850 
1.000      Blende

    Full comment: Blended, %CT unknown

0103297000 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      Blende

    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 1CD  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, garden, 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                 14.000000   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  22  

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  

0402085001 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  

0502229000 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    Soybean, 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 
1.000      

0603030000 6C   Bean, black, seed                  0.900000   1.000 
1.000      

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      

0603036000 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   Bean, 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  

0801375001 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 comment: 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

0802271001 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   1.000 
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   1  

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               0.110000   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  

1202012001 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-babyfood                     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   4.000 
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  

1302136000 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  Gooseberry                         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 
1.000  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 byproducts              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 
1.000      

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                          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      

3400290000 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   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                          1.500000   1.000 
1.000      

3400293001 34   Pork, fat-babyfood                 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                         1.500000   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      

3600223001 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                      0.052000   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)-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      

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   2.700 
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  21  

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 

Youth 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    11.14    0.030965  
 25.80 

Female 13-49:

                    0.007511     6.26    0.013145    10.95    0.026456  
 22.05



Attachment 3: Chronic Risk Assessment Input File and Result File

Filename: C:\Documents and Settings\iencarna\My Documents\DEEM Version
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       0.160000   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  

0103082000 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                      0.004000   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  

0103298001 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, tuber, 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  

0103407000 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   Broccoli                           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 
1.000  

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 
1.000  

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   Cabbage, 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    Soybean, 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   1.000 
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 8A   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  

0902308000 9B   Pumpkin                            0.033100   1.000 
1.000  

0902309000 9B   Pumpkin, seed                      0.033100   1.000 
1.000  

0902356000 9B   Squash, summer                     0.033100   1.000 
1.000  

0902356001 9B   Squash, summer-babyfood            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             0.740000   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  

1100009001 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                             0.740000   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  

1100268000 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             0.250000   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  

1202014000 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, prune, 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  Huckleberry                        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 
1.000  

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 
1.000  

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   Beef, 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   Pork, 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   1.000 
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 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                      0.052000   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                        0.457000   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  

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)-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  

8601000000 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 
1.000  

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    Peppermint, 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

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

                                                    Total 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%

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

Attachment 4:  Screening Level Estimates of Agricultural Uses of
Indoxacarb (067710), October 12, 2012, Reporting Years: 2004-2011

	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	       4,000	  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.

 NC: not calculated, 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)

These results reflect amalgamated data developed by the Agency and are
releasable to the public.

Attachment #5: Highest/average residues of indoxacarb in feedstuff
commodities6

1.  Wet apple pomace (CC)1

Processing factor = 2.6x; Highest field trial residue 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 byproducts (R)1 

Highest field trial residue adjusted 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.  Soybean seed (PC)3

Average field trial = 0.088 ppm 

10.  Soybean hulls (R)3,4 

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Processing Factor4 = 8.2x; Average field trial of soybean seed3 = 0.088
ppm

Average residue in soybean 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 trial 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.

Indoxacarb	Dietary Exposure Assessment	DP Bar code: 408983

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