EPA Registration Division contact: Laura Nollen, (703) 305-7390

Interregional Research Project Number 4 (IR-4)

Petition Number (PP#) 2E8029

EPA has received a pesticide petition, PP# 2E8029, from Interregional Research Project 

Number 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 

College Road East, Suite 201 W, Princeton, NJ 08450 proposing, pursuant to section 408(d) of 

the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 

180.564 by establishing a tolerance for residues of the combined residues of Indoxacarb, (S)-methyl 

7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]carbonyl]-

indeno[1,2e]-[1,3,4]oxadiazine-4a(3H)- carboxylate and its R-enantiomer (R)-methyl-7-chloro-2,5-

dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]carbonyl]-indeno [1,2-e] [1,3,4]

oxadiazine-4a(3H)- carboxylate in a 75:25 mixture (DPX-MP062), respectively, in or on the raw 

agricultural commodity bean, dry, seed at 0.07 parts per million (ppm); bean, succulent at 0.64 

ppm; bean, forage (foliage of leguminous vegetables/cow pea foliage) at 37 ppm; small fruit,

vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; and berry, low growing,

except strawberry, subgroup 13-07H at 0.9 ppm. Upon approval of the aforementioned tolerances, 

the petition additionally requests to remove the established tolerances in or on grape at 2.0 ppm and 

cranberry at 0.90 ppm. in EPA has determined that the petition contains data or information 

regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully

evaluated the sufficiency of the submitted data at this time or whether the data supports granting of 

the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

The active ingredient in the end-use formulation DuPont Avaunt® Insecticide is a 75:25 mixture 

of two isomers, indoxacarb (DPX-KN128) and IN-KN127. Only one of the isomers, indoxacarb 

(DPX-KN128), has insecticidal activity. The active ingredient in the end-use formulation, 

DuPontTM Steward® EC Insecticide is indoxacarb; no IN-KN127 is present. Since the 

insecticidal efficacy is based on the concentration of indoxacarb (DPX-KN128), the application 

rates have been normalized on an indoxacarb (DPX-KN128) basis. The proposed tolerance 

expression includes both indoxacarb (DPX-KN128) and IN-KN127 and the residue method does 

not distinguish between the enantiomers, therefore residues are reported as the sum of indoxacarb 

(DPX-KN128) combined with IN-KN127. Residues of indoxacarb (DPX-KN128) combined with 

IN-KN127 will be referred to as "KN128/KN127." 

 

1. Plant metabolism. The metabolism of indoxacarb in plants is 

adequately understood to support these tolerances. Plant metabolism studies in cotton, lettuce, 

and tomatoes showed no significant metabolites. The only significant residue was parent 

compound.

2. Analytical method. The plant residue enforcement method 
2

detects and quantitates indoxacarb in various matrices including sweet corn, lettuce, tomato, 

broccoli, apple, grape, cottonseed, tomato, peanut and soybean commodity samples by HPLC

UV. The limit of quantitation in the method allows monitoring of crops with indoxacarb residues 

at or above the levels proposed in these tolerances.

3. Magnitude of residues. Nine field trials were conducted on snap 

beans. Each field trial site consisted of one untreated control plot and one treated plot. At all the 

trials the test substance was applied as a foliar application. Four applications, six to eight days 

apart, were made at the maximum use rate of 0.119 lb of indoxacarb active ingredient per acre 

(0.457 lb of active ingredient maximum seasonal use rate). Harvesting was done 2-3, 7 and 13

days after the last application. For the pods with seeds samples (at the 2 – 3 day PHI), the 

residue levels ranged from 0.04 to 0.59 ppm and for the plant samples (at the 2 – 3 day PHI), the 

residue levels range from 1.3 to 32.1 ppm. 

Thirteen field trials were conducted on dry

beans. Each field trial site consisted of one untreated control plot and one treated plot. At all the 

trials the test substance was applied as a foliar application. Four applications, six to eight days 

apart, were made at 0.106 to 0.118 lb of indoxacarb active ingredient per acre (0.438 to 0.463 lb 

of active ingredient maximum seasonal use rate). Harvesting was done 6-8 days after the last 

application. The residue levels in the harvested beans ranged from < 0.01 ppm to 0.093 ppm. 

B. Toxicological Profile

1. Acute toxicity. Based on EPA criteria, indoxacarb is classified as follows for Toxicity

Categories

Guideline Title Results Category

870.1100

870.1200

870.1300

870.2400

870.2500

Acute Oral Toxicity

Acute Dermal Toxicity

Acute Inhalation Toxicity

Primary Eye Irritation

Primary Dermal Irritation

Skin Sensitization

LD50:1730 mg/kg (M Rat)

LD50: 268 mg/kg/(F Rat)

LD50: >5000 mg/kg (Rat)

LC50: >5.5 mg/L (M Rat)

(70% MUP)

Effects reversed within 72 hours 

(Rabbit)

No irritation (Rabbit)

Category II

Category IV

Category IV

Category III

Category IV
3

870.2600 Sensitizer (Guinea Pig) ---------------

Formulated products are slightly less acutely toxic than indoxacarb. 

In an acute neurotoxicity study, indoxacarb exhibited decreased forelimb grip strength, decreased 

foot splay, and some evidence of slightly reduced motor activity, but only at the highest doses 

tested. The NOAEL was 100 mg/kg for males and 12.5 mg/kg for females based on body weight 

effects in females  50 mg/kg.]

2. Genotoxicty. [Indoxacarb has shown no genotoxic activity in the following listed 

in-vitro and in-vivo tests: 

Ames-- Negative 

In-vitro mammalian gene mutation (CHO/HGPRT)-- Negative 

In-vitro unscheduled DNA synthesis-- Negative 

In-vitro chromosomal aberration-- Negative 

In-vivo mouse micronucleus-- Negative]

3. Reproductive and developmental toxicity. The results of a series 

of studies indicated that there were no reproductive, developmental or teratogenic hazards 

associated with the use of indoxacarb. In a 2-generation rat reproduction study, the parental 

NOAEL was 1.5 mg/kg/day. The parental NOAEL was based on observations of reduced weight 

gain and food consumption for the higher concentration groups of the F0 generation and potential 

treatment-related changes in spleen weights for the higher groups of the F1 generation. There was 

no effect on mating or fertility. The NOAEL for fertility and reproduction was 6.4 mg/kg/day. The 

offspring NOAEL was 1.5 mg/kg/day, and was based on the reduced mean pup weights noted for 

the F1 litters of the higher concentration groups. The effects on pup weights occurred only at a 

maternal effect level and may have been due to altered growth and nutrition in the dams. In studies 

conducted to evaluate developmental toxicity potential, indoxacarb was neither teratogenic nor 

uniquely toxic to the conceptus (i.e., not considered a developmental toxin). Developmental studies 

conducted in rats and rabbits demonstrated that the rat was more susceptible than the rabbit to the 

maternal and fetal effects of DPX- MP062. Developmental toxicity was observed only in the 

presence of maternal toxicity. The NOAEL for maternal and fetal effects in rats was 2 mg/kg/day

based on body weight effects and decreased food consumption at 4 mg/kg/day. The NOAEL for 

developmental effects in fetuses was >4 mg/kg/day. In rabbits, the maternal and fetal NOAELS 

were 500 mg/kg/day based on body weight effects, decreased food consumption in dams and 

decreased weight and delayed ossification in fetuses at 1000 mg/kg/day.

In a developmental neurotoxicity study, dams administered 3 mg/kg/day from 

gestation day 6 through lactation day 10 had decreased body weight, weight gain, and food 

consumption; increased incidences of clinical signs of toxicity; and test substance-related 

mortality. At maternally toxic doses of 3 mg/kg/day, there was also an increase in offspring 
4

effects including lower body weight. In addition, beginning on lactation day 11, offspring were 

directly administered the test substance daily by oral gavage through lactation day 21. There 

were no effects in offspring on learning and memory, sexual maturation, motor activity, acoustic 

startle habituation, terminal body weights, brain weights, selected hematology parameters, 

neuromorphometric parameters, or neurohistopathology. There were no biologically significant 

effects on dams or offspring administered dosages of 1.5, 1, or 0.5 mg/kg/day.

4. Subchronic toxicity. Subchronic (90-day) feeding studies were conducted with rats, 

mice, and dogs. In a 90-day feeding study in rats, the NOAEL was 3.1 and 2.1 mg/kg/day for males 

and females, respectively. In male rats, the NOAEL was based on decreased body weight and 

nutritional parameters, mild hemolytic anemia and decreased total protein and globulin 

concentration. In female rats, the NOAEL was based on decreased body weight and food efficiency. 

In a subchronic neurotoxicity study in rats, there was no evidence of neurotoxicity at 11.9 and 

6.09 mg/kg/day, the highest dose tested for males and females, respectively. The subchronic 

NOAEL in dogs (5.0 mg/kg/day, M/F) was based on hemolytic anemia. Erythrocyte values for most 

dogs were within a range that would be considered normal for dogs in a clinical setting. Mice were 

less sensitive to indoxacarb than the rats or dogs. NOAELs (23 mg/kg/day, males, 16 mg/kg/day, 

females) were based on mortality (males only); increased reticulocytes and Heinz bodies and 

decreased body weight, weight gain, food consumption, food efficiency; and increased clinical 

signs (leaning to one side and/or with abnormal gait or mobility) (females only). In a 28-day

repeated dose dermal study, the NOAEL was 50 mg/kg/day based on decreased body weights, body

weight gains, food consumption, and food efficiency in females, and changes in hematology

parameters, the spleen and clinical signs of toxicity in both sexes in rats.

]

5. Chronic toxicity. Chronic studies with indoxacarb were conducted on rats, mice, and 

dogs to determine oncogenic potential and/or chronic toxicity of the compound. Effects generally

similar to those observed in the 90-day studies were seen in the chronic studies. Indoxacarb was not 

oncogenic in rats or mice. The chronic NOAEL in male rats was 5 mg/kg/day based on body weight 

and nutritional effects. In females, the NOAEL of 2.1 mg/kg/day was based on body weight and 

nutritional changes, as well as biologically significant hematologic changes at 3.6 mg/kg/day and 

above. Hemolytic effects were present only through the 6-month evaluation and only in females. 

The regenerative nature of indoxacarb-induced hemolytic anemia was demonstrated by the absence 

of significant changes in indicators of circulating erythrocyte mass at later evaluations. In mice, the 

chronic NOAEL of 2.6 mg/kg/day for males was based on deceased body weight and weight gain 

effects and food efficiency at 13.8 mg/kg/day and above. The NOAEL for females was 4.0 

mg/kg/day based on body weight nutritional effects, neurotoxicity, and clinical signs at 20 

mg/kg/day. In dogs, the chronic NOAEL was about 2.3 and 2.4 mg/kg/day in males and females, 

respectively based on hemolytic effects similar to those seen in the subchronic dog study.
5

6. Animal metabolism. Livestock animal metabolism. Animal metabolism has been 

studied in the rat, hen, and cow and is well understood. In contrast to crops, indoxacarb is 

extensively metabolized in animals.

Poultry. In poultry, hens were fed at 10 ppm/day for 5 days, 87-88% of the total administered dose 

was excreted; parent comprised 51-54% of the total dose in excreta. Concentrations of residues in 

eggs were low, 0.3-0.4 of the total dose, as were the concentrations of residues in muscle, 0.2% of 

the total dose. Parent and metabolite IN-JT333 were not detected in egg whites; only insecticidally

inactive metabolites were identified. Parent and IN-JT333 were found in egg yolks; however, their 

concentrations were very low-0.01-0.02 ppm. Concentrations of parent and IN-JT333 in muscle 

were at or below the limit of quantitation, (LOQ) (0.01 ppm). 

Poultry Feeding study. Four groups of laying hens (10/ group) were dosed orally once a day for 28 

consecutive days-with capsules containing indoxacarb at levels equivalent to target concentrations 

of 1.75, 7.0, 21.0, and 70.0 ppm in the feed on a dry weight basis. Residues of each analyte 

plateaued in whole eggs within 14-21 days of dosing. Residues in fat, skin, and liver were dose 

dependent, particularly for the top three dose levels.

The maximum combined residues in fat were 0.11, 0.54, 1.5, and 5.0 ppm from the 1.75, 7, 21, and 

70 ppm dose groups, respectively; and combined residues in fat averaged 0.10, 0.44, 1.4, and 4.13 

ppm from the respective dose groups. The maximum combined residues inskin were 

<0.07,0.17,0.60, and 1.20 ppm from the 1.75,7,21, and 70 ppm dose groups, respectively; and 

combined residues in skin averaged <0.07,0.12,0.51, and 1.06 ppm from the respective dose 

groups. In liver, the maximum combined residues were <0.06, <0.09, 6.21, and 0.67 ppm from the 

1.75,7,21, and 70 ppm dose groups, respectively; and combined residues in liver averaged 0.03, 

0.08, 0.18, and 0.52 ppm from the respective dose groups In composited muscle, the maximum 

combined residues were <0.06 ppm from the 1.75 and 7 ppm dose groups, <0.07 ppm from the 21 

ppm dose group, and 0.15 ppm from the 70 ppm dose group. Combined residues in muscle 

averaged 0.03, 0.03, 0.06, and 0.12 ppm from the 1.75, 7, 21, and 70 ppm dose groups, 

respectively.

Following a 28-day recovery period for hens dosed at 70 ppm, residues of each analyte were nondetectable «0.003 ppm) in skin, liver, and muscle. Residues of each analyte were also <0.003 ppm 

in fat with the exception of IN-JT333, which had detectable residues (0.004-0.009 ppm) below the 

method LOQ. following the cessation of dosing average combined residues in eggs declined from 

0.65 ppm at 2 days post-dose to 0.07 ppm by 9 days post-dose. By 12 days postdose, residues of 

each analyte, except IN-JT333, were <0.003 ppm in eggs, and residues of IN-JT333 declined to 

<0.003 ppm by 23 days post-dose.

Cattle. For the cow study, the cattle were fed at 10 ppm/day for 5-days; approximately 20% of the 

total administered dose was excreted in urine and 53-60% was excreted in feces in 5-days. Fourtenths to 1.2% of the total dose in urine was parent indicating extensive metabolism; parent 

represented 46-68% of the fecal activity. Thus, most residues were not absorbed; those residues that 

were absorbed were extensively metabolized. Less than 1% of the total administered dose was in 
6

milk, most of which was parent compound. The insecticidally active metabolite IN-JT333 was not 

found in milk. Residues in muscle represented less than 0.01% of the total administered dose most 

of which was parent. IN-JT333 was not detected in muscle. No other metabolites were seen above 

10% of the dose, thus only parent and IN-JT333 were monitored in the cattle feeding study. 

Cattle feeding study. A cattle feeding study was conducted with indoxacarb at doses of 7.5 ppm, 

22.5 and 75 ppm. The mean KN128/KN127 concentrations were proportional to the dosing level in 

whole milk, skim milk, cream, muscle, fat, liver and kidney. Based on final residue values for the 

respective commodities contributing to the cattle diet, the anticipated dietary burden in dairy cattle 

is 51.7 ppm and the anticipated dietary burden in beef cattle is 49.1 ppm. The proposed grape use 

will not increase the animal dietary burden. Based on standard curves constructed from data in the 

cattle feeding study, KN128/KN127 concentrations at the 51.7-ppm feeding level are 0.123 ppm for 

whole milk, 0.033 ppm for skim milk and 1.46 ppm for cream. The KN128/KN127 concentrations 

at the 49.1 ppm feeding level are 0.046 ppm for muscle, 1.37 ppm for fat, 0.012 ppm for liver and 

0.026 ppm for kidney. Tolerances have been established at 1.5 ppm in fat (cattle, goat, horse, sheep 

and hog), 0.05 ppm in meat, 0.03 ppm in meat by-products, 0.15 ppm in milk and 4.0 ppm in milk 

fat. 

7. Metabolite toxicology. In rats, indoxacarb was readily absorbed at low dose (5 

mg/kg), but saturated at the high dose (150 mg/kg). Indoxacarb was metabolized extensively, based 

on very low excretion of parent compound in bile and extensive excretion of metabolized dose in 

the urine and feces. Some parent compound remained unabsorbed and was excreted in the feces. No 

parent compound was excreted in the urine. The retention and elimination of the metabolite 

IN-JT333 from fat appeared to be the overall rate determining process for elimination of radioactive 

residues from the body. Metabolites in urine were cleaved products (containing only one 

radiolabel), while the major metabolites in the feces retained both radiolabels. Major metabolic 

reactions included hydroxylation of the indanone ring, hydrolysis of the carboxylmethyl group from 

the amino nitrogen and the opening of the oxadiazine ring, which gave rise to cleaved products. 

Metabolites were identified by mass spectral analysis, NMR, UV and/or by comparison to standards 

chemically synthesized or produced by microsomal enzymes.

8. Endocrine disruption. Lifespan, and multigenerational bioassays in mammals and 

acute and subchronic studies on aquatic organisms and wildlife did not reveal endocrine effects. 

Any endocrine related effects would have been detected in this definitive array of required tests. 

The probability of any such effect due to agricultural uses of indoxacarb is negligible.

C. Aggregate Exposure

Tolerances for indoxacarb are proposed to support agricultural use on succulent beans, dried beans, 

and the crops of subgroups 13-07 F and 13-07 H. 

1. Dietary exposure. The chronic RfD of 0.02 mg/kg bw/day is based on a NOAEL of 
7

2.0 mg/kg bw/day from the subchronic rat feeding study, the subchronic rat neurotoxicity study, and 

the chronic/carcinogenicity study, using an uncertainty factor of 100. The acute RfD for the general 

population is 0.12 mg/kg/day, based on the NOAEL of 12.5 mg/kg in the acute neurotoxicity study

and an uncertainty factor of 100. The acute RfD for females 13-50 years of age is 0.02 mg/kg/day, 

based on the NOAEL of 2 mg/kg/day observed in the developmental rat toxicity study and using an 

uncertainty factor of 100.

i. Food. Chronic dietary exposure assessment. Chronic dietary exposure resulting from 

the currently approved use of indoxacarb on apples, Crop group 5 (brassica vegetables), cotton, 

pears, peppers, sweet corn, tomatoes, eggplant, alfalfa, head and leaf lettuce, peanuts, potatoes, 

soybeans, cranberries (current Section 18 use) and the proposed uses on grapes, leafy Brassica, 

leafy greens crop subgroup 4A (except spinach), spinach, leaf petioles crop subgroup 4B, tuberous 

and corm vegetables crop subgroup 1C, pome fruits crop group 11 (except pear), okra, pea 

(Southern) and mint are well within acceptable limits for all sectors of the population. The Chronic 

Module of the Dietary Exposure Evaluation Model (DEEM, Exponent, Inc., formerly Novigen 

Sciences, Inc., Version 7.87) was used to conduct the assessment with the reference dose (RfD) of 

0.02 mg/kg/ day. The analysis used overall mean field trial values, processing factors and projected 

peak percent crop treated values. Secondary residues in milk, meat and poultry products were also 

included in the analysis. The chronic dietary exposure to indoxacarb is 0.000185 mg/kg/day, and 

utilizes 1% of the RfD for the overall U.S. population. The exposure of the most highly exposed 

subgroup in the population, children age 1-2 years, is 0.000347 mg/kg/day, and utilizes 2% of the 

RfD. The table below lists the results of this analysis, which indicate large margins of safety for 

each population subgroup and very low probability of effects resulting from chronic exposure to 

indoxacarb.
8

Subgroup Maximum Dietary

Exposure (mg/kg/day)

% RfD

U.S Population

All infants

Males 13-19

Males 20+

Seniors 55+

Children 1-2

Children 3-5

Children 6-12

Youth 13-19

Adults 20-49

Adults 50+

Females 13-19 

(not preg or nursing)

Females 20+ 

(not preg or nursing)

0.000185

0.000126

0.000183

0.000165

0.000186

0.000347

0.000315

0.000191

0.000171

0.000163

0.000186

0.000157

0.000179

1

1

1

1

1

2

2

1

1

1

1

1

1

Acute dietary exposure. Acute dietary exposure resulting from the proposed uses and 

the currently approved use of indoxacarb on apples, Crop Group 5 (brassica vegetables), cotton, 

pears, peppers, sweet corn, tomatoes, eggplant, alfalfa, head and leaf lettuce, peanuts, soybeans, 

potatoes, cranberries (current Section 18 use) and the proposed uses on grapes, leafy Brassica, 

leafy greens crop subgroup 4A (except spinach), spinach, leaf petioles crop subgroup 4B, 

tuberous and corm vegetables crop subgroup 1C, pome fruits crop group 11 (except pear), okra, 

pea (Southern) and mint are well within acceptable limits for all sectors of the population. The 

Dietary Exposure Evaluation Model (DEEM, Exponent, Inc., formerly Novigen Sciences, Inc., 

Version 7.87) was used to conduct the assessment. Margins of exposure (MOE) were calculated 

based on a NOAEL of 12 mg/kg/day for children and the general population (Pesticide Fact 

Sheet for Indoxacarb). An endpoint of concern attributable to a single dose was not identified for 

women of childbearing age; therefore an acute RfD was not established for this population. The 

Tier 3 analysis used distributions of field trial residue data adjusted for projected peak percent 

crop treated. Secondary residues in milk, meat and poultry products were also included in the 

analysis. The results of this analysis are given in the table below. The percent of the acute 

population adjusted dose (a PAD) for all population subgroups shows that an adequate margin of 

safety exists in each case. Thus, the acute dietary safety of indoxacarb for established and the 

follow-on use clearly meets the FQPA standard of reasonable certainty of no harm and presents 

acceptable acute dietary risk.
9

Subgroup 99.9th Percentile Of Exposure

Exposure 

(mg/kg/day)

% Acute 

population 

adjusted dose 

(aPAD)

U.S. Population

All infants

Males 13-19

Males 20+

Seniors 55+

Children 1-2

Children 3-5

Children 6-12

Youth 13-19

Adults 20-49

Adults 50+

0.020267

0.018458

0.029223

0.019257

0.020072

0.036020

0.005358

0.017498

0.022245

0.018887

0.019883

17

15

24

16

17

23

30

15

19

16

17

ii. Drinking water. Indoxacarb is highly unlikely to contaminate groundwater resources 

due to its immobility in soil, low water solubility, high soil sorption, and moderate soil half-life. 

Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations 

(EECs) of indoxacarb and its R-enantiomer for acute exposures are estimated to be 6.84 parts per 

billion (ppb) for surface water and 0.0025 ppb for ground water. The EECs for chronic exposures 

are estimated to be 0.316 ppb for surface water and 0.0025 ppb for ground water. Drinking water 

levels of comparison (DWLOCs), theoretical upper allowable limits on the pesticide=s 

concentration in drinking water, were calculated to be much higher than the EECs. The chronic 

DWLOCs ranged from 198 to 697 ppb. The acute DWLOCs ranged from 440 to 3890 ppb. Thus, 

exposure via drinking water is acceptable.

2. Non-dietary exposure. Indoxacarb product registrations for residential non-food uses 

have been approved. Non-occupational, non-dietary exposure for DPX- MP062 has been estimated 

to be extremely small. Therefore, the potential for non-dietary exposure is insignificant.

D. Cumulative Effects

EPA's consideration of a common mechanism of toxicity is not necessary at this time 

because there is no indication that toxic effects of indoxacarb would be cumulative with those of 

any other chemical compounds. Oxadiazine chemistry is new, and indoxacarb has a novel mode of 

action compared to currently registered active ingredients.
10

E. Safety Determination

1. U.S. population. Dietary and occupational exposure will be the major routes of 

exposure to the U.S. population, and ample margins of safety have been demonstrated for both 

situations. The chronic dietary exposure to indoxacarb is 0.000185 mg/kg/day, which utilizes 1% of 

the RfD for the overall U.S. population, using mean field trial values, processing factors and 

projected peak percent crop treated values. The percent of the acute population adjusted dose (17% 

aPAD) for the overall U.S. population shows that an adequate margin of safety exists. Using only

PHED data levels A and B (those with a high level of confidence), MOEs for occupational 

exposure are 650 for mixer/loaders and 1351 for airblast applicators (worst-case). Based on the 

completeness and reliability of the toxicity data and the conservative exposure assessments, there is 

a reasonable certainty that no harm will result from the aggregate exposure of residues of 

indoxacarb including all anticipated dietary exposure and all other non-occupational exposures. 

2. Infants and children. Chronic dietary exposure of the most highly exposed subgroup 

in the population, children age 1-2 years, is 0.000347 mg/kg/day or 2% of the RfD. For all infants, 

the exposure accounts for 1% of the RfD. For acute exposure at the 99.9th percentile (based on a 

Tier 3 assessment) the exposure was 0.005358 mg/kg/day (30% aPAD) for children 3-5 and 

0.018458 mg/kg/day (15% aPAD) for all infants. Residential uses of indoxacarb have been 

approved and exposure is calculated to be extremely minimal. The estimated levels of indoxacarb 

in drinking water are well below the below the DWLOC. Based on the completeness and reliability

of the toxicity data, the lack of toxicological endpoints of special concern, the lack of any indication 

that children are more sensitive than adults to indoxacarb, and the conservative exposure 

assessment, there is a reasonable certainty that no harm will result to infants and children from the 

aggregate exposure of residues of indoxacarb, including all anticipated dietary exposure and all 

other non-occupational exposures. Accordingly, there is no need to apply an additional safety factor 

for infants and children.

F. International Tolerances

To date, numerous tolerances exist for indoxacarb residues in various food and feed 

crops and foods of animal origin in at least 25 countries.