E. I. DuPont de Nemours & Company Chlorantraniliprole 

 Page 1 of 7 

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

ENVIRONMENTAL PROTECTION AGENCY 

Notice of Filing of a Pesticide Petition for the Establishment of Tolerances for 

Residues of Chlorantraniliprole in or on Food Commodities 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Notice. 

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

SUMMARY: This notice announces the initial filing of a pesticide petition 

proposing the establishment of tolerances for residues of chlorantraniliprole in or 

on food commodities under the Federal Food, Drug, and Cosmetic Act (FFDCA), 

as amended by the Food Quality Protection Act of 1996 (FQPA). 

FOR FURTHER INFORMATION CONTACT: By mail: [EPA Product 

Manager], Product Manager (PM), Registration Division, (7505), Office of 

Pesticide Programs, Environmental Protection Agency, Ariel Rios Building 1200 

Pennsylvania Avenue, N. W., Washington, DC 20460. Office location and 

telephone number: , Arlington, VA., (703) 306-0415. Email: 

manager.product@epa.gov. 

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as 

follows proposing the establishment and/or amendment of regulations for residues 

of certain pesticide chemicals in or on bushberries, subgroup 13-07B; cucurbit 

vegetables, group 9; fruiting vegetables, group 8; large shrub/tree berries, 

subgroup 13-07C; low growing berries, subgroup 13-07G; okra; onion, bulb, 

subgroup 3-07A; peanut, hay; peanut, nutmeat; root and tuber vegetables, group 

1; sugar beet molasses; ti palm; leaves of root and tuber vegetables, group 2; and 

dried tea leaves under section 408(d) of the Federal Food, Drug, and Cosmetic 

Act (FFDCA), 21 U.S.C. 346a (d). EPA has determined that this petition contains 

data or information regarding the elements set forth in section 408(d)(2); 

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. 

 

List of Subjects 

Environmental Protection, Agricultural Commodities, Food Additives, Feed 

Additives, Pesticides and Pests, Reporting and Recordkeeping Requirements. 

Summary of Petition 
E. I. DuPont de Nemours & Company Chlorantraniliprole 

 Page 2 of 7 

A summary of the pesticide petition is given below. The petitioner prepared the summary 

of the petition. 

EPA Registration Division contact: Product Manager, (703) XXX-XXXX

 E. I. DuPont de Nemours and Company, DuPont Crop Protection 

[Insert petition number]

 EPA has received a pesticide petition ([insert petition number]) from E. I. 

DuPont de Nemours and Company, DuPont Crop Protection, Wilmington, Delaware, 

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 to establish tolerances for 

residues of chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-

[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide in 

or on bushberry, subgroup 13-07B at 2.5 ppm; large shrub/tree berry, subgroup 13-07G at 

2.5 ppm; low growing berry, subgroup 13-07G at 2.5 ppm; ti palm, roots at 0.35 ppm; ti 

palm, leaves at 13 ppm; root and tuber vegetables, group 1 at 0.35 ppm; leaves of root 

and tuber vegetables, group 2 at 40 ppm; sugar beet molasses at 11 ppm; onion, bulb, 

subgroup 3-07A at 0.35 ppm; peanut, nutmeat at 0.35 ppm; peanut, hay at 90 ppm; tea, 

dried leaves at 50 ppm and to increase tolerances in or on fruiting vegetables (except 

cucurbits), group 8 from 0.70 ppm to 0.90 ppm; cucurbit vegetables, group 9 from 0.25 

ppm to 0.30 ppm; and okra from 0.70 ppm to 0.90 ppm . 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 

1. Plant metabolism. The metabolism of chlorantraniliprole is adequately 

understood to support the proposed exemption from the requirement of tolerances. 

Studies in apple, lettuce, rice, tomato, and cotton when treated at proposed label 

rates showed no significant metabolites. The only significant residue is the parent 

compound. 

2. Livestock Metabolism. The metabolism of chlorantraniliprole in ruminants and 

poultry is adequately understood to support the exemption from the requirement 

of tolerances. Lactating goat and laying hen metabolism studies were conducted. 

The goat and hen rapidly excreted >93% and >98% of the dosed radiolabeled 

residues, respectively. 

The metabolic pathway in poultry and ruminant (goat) animals was consistent. 

There is no reasonable expectation of transfer of finite residues of 

chlorantraniliprole and its metabolites to fat, meat, milk, and eggs. 
E. I. DuPont de Nemours & Company Chlorantraniliprole 

 Page 3 of 7 

3. Analytical method. Since chlorantraniliprole and its metabolic degradates are 

not of toxicological concern, analytical methods are not applicable. 

4. Magnitude of residues. Field residue trials were conducted on cucumber, 

summer squash, melon, bell pepper, non-bell pepper, tomato, celery, head lettuce, 

leaf lettuce and spinach with and without adjuvants. Residues of 

chlorantraniliprole found in replicate trials in fruiting vegetables treated with 

adjuvants may result in higher residues on average by a factor of 1.1-1.3× as 

compared to the same crops that were not treated with adjuvants. Residues of 

chlorantraniliprole found in replicate trials in leafy, cucurbit and non-cucurbit 

vegetables treated with adjuvants may result in higher residues on average by a 

factor of 1.0-1.3×. 

Six residue trials were conducted with radishes which were treated at the 

proposed maximum labeled rate and harvested at the minimum pre-harvest 

interval. Residues of chlorantraniliprole found in replicate treated samples 

collected 1 day after last application ranged from 3.6 to 22 mg/kg with an average 

11 ± 5.6 mg/kg for radish tops and from 0.021 to 0.26 mg/kg with an average 

0.076 ± 0.075 mg/kg for radish roots. 

In eleven field trials, two foliar broadcast or directed applications of 

chlorantraniliprole were made to blueberries at a rate of approximately 0.1 lb ai/A 

each, for a total of approximately 0.2 lb ai/A. No adjuvant was added to the spray 

mixtures. The applications were made 7±1 days apart and timed so that 

commercially mature blueberries could be collected 1 day after the final 

application. The maximum residue in blueberry following a total application of 

approximately 0.2 lb ai/A and a pre-harvest interval (PHI) of 1 day was 0.908 

ppm. 

In six field trials, two foliar applications of chlorantraniliprole were made to 

cranberries at a rate of approximately 0.1 lb ai/A each, for a total of 

approximately 0.2 lb ai/A. No adjuvant was added to the spray mixtures. The 

applications were made 7±1 days apart and timed so that commercially mature 

cranberries could be collected 1 day after the final application. The maximum 

residue in cranberry following a total application of approximately 0.2 lb ai/A and 

a pre-harvest interval (PHI) of 1 day was 0.211 ppm. 

Numerous residue studies have been conducted on many crops in the United 

States and globally by the registrant and by other organizations such as the IR-4 

Project. The relevant U.S. and foreign residue study reports required to support 

use of chlorantraniliprole and existing tolerances in the United States have been 

submitted to EPA and reviewed as part of prior registration actions for this active 

ingredient. 
E. I. DuPont de Nemours & Company Chlorantraniliprole 

 Page 4 of 7 

B. Toxicological Profile

 1. Acute toxicity. Based on EPA criteria, chlorantraniliprole is classified 

as follows for Toxicity Categories: 

 

Guideline Title Results Category 

870.1100 

870.1200 

870.1300 

870.2400 

870.2500 

870.2600 

Acute Oral Toxicity 

Acute Dermal Toxicity 

Acute Inhalation Toxicity 

Primary Eye Irritation 

Primary Dermal Irritation 

Skin Sensitization 

LD50: >5,000 mg/kg (Rat) 

LD50: >5,000 mg/kg (Rat) 

LC50: >5.1 mg/L (Rat) 

Mild irritation (Rabbit) 

No irritation (Rabbit) 

Not a sensitizer (Mouse LLNA) 

Category IV 

Category IV 

Category IV 

Category IV 

Category IV 

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

 Formulated products are as equally non-toxic following acute exposures as is 

technical chlorantraniliprole. The acute inhalation toxicity for the suspension concentrate 

formulation could not be determined above the maximum practically attainable 

atmospheric aerosol concentration of 2 mg/L. 

There was no evidence of neurotoxicity in rats following a single limit dose of 2,000 

mg/kg 

 2. Genotoxicty. Chlorantraniliprole has shown no genotoxic activity in the following 

listed in vitro and in vivo tests: 

 Bacterial reverse mutation 

 In vitro mammalian gene mutation (CHO/HGPRT) 

 In vitro chromosomal aberration (human lymphocytes) 

 In vivo mouse micronucleus 

 3. Reproductive and developmental toxicity. In developmental toxicity studies in 

rats and rabbits, chlorantraniliprole exhibited no effects on any parameter in pregnant 

females or their offspring at levels up to and including the maximum tested dose of 1,000 

mg/kg bw/day. 

 No reproductive toxicity was observed in a two-generation reproduction study with 

chlorantraniliprole in rats. No adverse effects were observed on reproduction, fertility, 

sperm parameters, estrous cycle, litter size, pup survival and developmental landmarks up to 

the maximum tested dose of 20,000 ppm in the diet. There were no adverse histological 

findings indicative of reproductive toxicity. There was a slight reduction in the F1 pup (but 

not F2 pup) weight during lactation at the highest dose level (mean maternal intake during 

lactation equal to 3,118 mg/kg bw/day); this was attributed, in part, to weight loss in one 

dehydrated dam during lactation which had a litter with some of the lowest pup weights. 

The slight change in pup weight was without subsequent effects since overall body weight, 
E. I. DuPont de Nemours & Company Chlorantraniliprole 

 Page 5 of 7 

weight gain and development in F1 rats fed 20,000 ppm were similar to control animals. 

 4. Subchronic toxicity. 

 Subchronic (90-day) feeding studies were conducted with rats, mice and dogs. No 

adverse effects were observed at the highest dietary concentrations tested of 20,000 ppm in 

rats (1,188 mg/kg bw/day for males and 1,526 mg/kg bw/day for females), 7,000 ppm in 

mice (1,135 mg/kg bw/day for males and 1,539 mg/kg bw/day for females) and 40,000 ppm 

in dogs (1,163 mg/kg bw/day for males and 1,220 mg/kg bw/day for females). 

Chlorantraniloprole showed no evidence of immunotoxicity in 28-day feeding studies in rats 

or mice and no evidence of neurotoxicity in a 90-day feeding study in rats at dietary 

concentrations greater than the limit dose of 1,000 mg/kg bw/day. 

 A 28-day dermal toxicity study in rats was conducted at doses of 100, 300 and 1,000 

mg/kg bw/day. The NOAEL for male and female rats was 300 mg/kg bw/day based on 

reductions in body weight gain and food efficiency at 1,000 mg/kg bw/day. 

 No adverse target organ effects were observed in any subchronic toxicity study. 

5. Chronic toxicity. 

 Chlorantraniliprole was not carcinogenic in either a 2-year study in rats or an 18-

month study in mice. The NOAEL for chronic toxicity in the 18-month mouse study was 

1,200 ppm (158 mg/kg bw/day in males) and was based on eosinophilic foci accompanied 

by hepatocellular hypertrophy and increased liver weight. 

 In rats, there were no adverse effects on any in-life parameter in either males or 

females administered chlorantraniliprole up to and including a maximum dietary 

concentration of 20,000 ppm for 2 years (805 and 1,076 mg/kg bw/day, respectively). 

 In a one-year feeding study in dogs, the NOAEL was the highest dose tested, 40,000 

ppm (1,164 and 1,233 mg/kg/day in males and females, respectively). 

6. Rat metabolism. 

The absorption of [14C]-chlorantraniliprole in rats was rapid with peak concentrations 

occurring at 5-12 hours after single dose administration. Tissue distribution of the absorbed 

dose was extensive and indicated low potential for accumulation. Excretion was 

substantially complete by 48-72 hours after dosing (>90%). 

 Following 14 days of oral administration 14C residues were readily eliminated from the 

plasma and tissues and confirmed minimal potential for accumulation. The profile of 

metabolites in urine and feces indicated extensive metabolism consistent with that observed 

for the single dose study. 

7. Metabolite toxicology. Due to the extremely low toxicity of the parent compound 

and the extensive metabolism observed in mammalian systems, chlorantraniliprole 

metabolites are not expected to result in any significant toxicity. Toxicology studies 

conducted with metabolites support this conclusion.
E. I. DuPont de Nemours & Company Chlorantraniliprole 

 Page 6 of 7 

8. Endocrine disruption. No adverse effects were observed on any endocrine tissue 

in short- and long-term studies in rats, mice and dogs. 

C. Aggregate Exposure

 1. Dietary exposure -- i. Food. Because an endpoint attributable to a single dose 

was not identified, the dietary exposure assessment considered only chronic exposure. 

Chronic dietary exposure assessments were conducted using the Dietary Exposure 

Evaluation Model (DEEM-FCIDTM, Version 2.03) which uses food consumption data 

from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by 

Individuals (CSFII) from 1994-1996 and 1998. The chronic dietary exposure assessment 

was conducted using a chronic reference dose of 1.58 mg/kg bw/day based on the 

NOAEL established in the 18-month study in mice. DuPont has conducted chronic 

assessments which assume that 100% of all crops – including those not labeled - are 

treated with chlorantraniliprole and that all crops contain residues at tolerance level or at 

residue levels equal to tolerance levels for similar crops. In particular all leafy 

vegetables, including leaves of root and tuber vegetables and leafy vegetables including 

brassica vegetables, are assumed to have residues of 15 parts per million. All other 

human foods (including plant and animal commodities) are assumed to have residues of 2 

parts per million. 

These assumptions result in conservative, health-protective estimates of exposure which 

are well below the Agency’s level of concern (100% of the cPAD). The maximum 

estimate is less than 11% of the cPAD for all population subgroups. 

ii. Drinking water. A drinking water assessment for chlorantraniliprole, 

conducted based on PRZM/EXAMS (Pesticide Root Zone Model/Exposure Analysis 

Modeling System), was used to calculate the surface water estimated drinking water 

concentrations (EDWCs) and the Screening Concentration in Ground Water (SCIGROW) model was used to calculate the groundwater EDWC. The EDWCs do not 

exceed the Agency’s level of concern. 

2. Non-dietary exposure. Residential exposure (non-occupational, non-dietary 

exposure to consumers) was conservatively assessed for dermal post-application 

exposure (children and adults), and for children the oral exposures via hand-to-mouth, 

object-to-mouth, and incidental ingestion of soil were also assessed. The margins of 

exposure (MOE) greatly exceed the 100-fold MOE required for these routes and from the 

combined children’s incidental oral ingestion. Therefore, residential non-dietary 

exposure is not a concern. 

D. Cumulative Effects

It is not necessary at this time to consider cumulative effects because there is no 

indication that toxic effects of chlorantraniliprole have a common mechanism with those 

of any other chemical compounds. 
E. I. DuPont de Nemours & Company Chlorantraniliprole 

 Page 7 of 7 

E. Safety Determination

 1. U.S. population. Based on risk assessments performed using worst-case 

exposure assumptions there is a reasonable certainty that no harm will result to the 

general population from the aggregate exposure to chlorantraniliprole. No additional 

safety factors are warranted.

2. Infants and children. Based on the risk assessments performed using worst-case 

exposure assumptions there is a reasonable certainty that no harm will result to the infants 

and children from the aggregate exposure to chlorantraniliprole. No additional safety 

factors are warranted. 

F. International Tolerances 

 Numerous chlorantraniliprole MRLs have been established or are expected to be 

established in 61 countries. Codex MRLs have also been established for 

chlorantraniliprole on numerous crops.