Document ID: EPA-HQ-OPP-2008-0549-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-09-08T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

     OFFICE OF	

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date: June 12, 2008

SUBJECT:	ID#: 08MN03 Section 18 Emergency Exemption for the Use of
Chlorantraniliprole on Sweet Corn in Minnesota.

PC Code:  090100	DP Barcode:  351271

MRID No.:  None	Registration No.: 08MN03

Petition No.:  None	Regulatory Action: Section 18

Assessment Type:  Single Chemical Aggregate	Reregistration Case No.:
None

TXR No.:  None

	

FROM:	Barry O’Keefe, Senior Biologist

		Leung Cheng, Senior Chemist

		Jack Arthur, Senior Environmental Scientist

		Registration Action Branch 3

		Health Effects Division (7509P)

		Office of Pesticide Programs

THRU:	Paula Deschamp, Branch Chief

		Registration Action Branch 3

		Health Effects Division (7509P)

		Office of Pesticide Programs

TO:	Marcel Howard

		Section 18 Team

		Minor Use, Inerts and Emergency Response Branch

		Registration Division (7505P)

		Office of Pesticide Programs

The Registration Division (RD) of the Office of Pesticide Programs (OPP)
has requested that HED evaluate the Section 18 Emergency Exemption
request for the first time use of the insecticide chlorantraniliprole to
control corn earworm on sweet corn.

INTRODUCTION

A Section 18 Emergency Exemption request has been received for the
first-time use of the insecticide chlorantraniliprole to control corn
earworm on sweet corn in all counties in Minnesota on up to a total of
40,050 acres.  The use sites intended to be treated include sweet corn
for processing and fresh market.  The use season is from July 20th to
September 30th.  The product to be used is Coragen (EPA Reg. No.
352-729), a liquid formulation containing 18.4% active ingredient (ai)
and 1.667 lb ai per gallon.

EXECUTIVE SUMMARY

General Information

Chlorantraniliprole, or DPX-E2Y45, is a novel anthranilic diamide
insecticide that belongs to a class of compounds that acts on the
ryanodine receptor (Group 28 based on the target site of action).  It is
an insecticide that was developed by DuPont for control of lepidopteran
pests and controls many insects primarily via interruption of normal
muscle contraction pathways, which leads to paralysis and eventual death
of the pest.  

DuPont has recently received approval for a Section 3 registration of
two agricultural end-use products (DupontTM CoragenTM SC Insecticide and
DupontTM AltacorTM WG Insecticide) and 13 products for use on turf and
ornamentals (DupontTM E2Y45 SC Insecticide, and 12 granular formulations
of varying concentrations ai).  Additionally the Louisiana Department of
Agriculture has recently received approval for a Section 18 exemption
for the use of DupontTM Dermacor X-100 Seed Treatment on rice seeds. 
These actions required the establishment of tolerances for resulting
residues of
3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chlor
o-2-pyridinyl)-1H-pyrazole-5-carboxamide in/on pome fruit, stone fruit,
leafy vegetables, Brassica leafy vegetables, cucurbit vegetables,
fruiting vegetables, cotton, grapes and potatoes and rice.

The proposed Section 18 use pattern for sweet corn is as follows: The
Minnesota Department of Agriculture has requested an emergency specific
exemption to use chlorantraniliprole (Coragen 20 SC a liquid insecticide
(EPA Reg. No. 352-TEO)) to control corn earworm on sweet corn in all
counties in Minnesota on up to a total of 40,050 acres.  This is the
first Section 18 request for this crop and use pattern.  The use sites
intended to be treated include sweet corn for processing and fresh
market.  The use season is from July 20th to September 30th.  The
maximum number of application will be two.  The proposed use is to apply
Coragen 20 SC by ground or aerial application methods at an application
rate of 0.045 to 0.098 lb ai/A and 3.5 to 7.5 fl oz/A per application,
with a maximum application rate of 0.2 lb ai/A per season.  The minimum
interval between treatments is one day.  A pre-harvest interval (PHI)
has not been specified; however, the residue data support a PHI of 1
day.

Toxicology

The toxicology database for chlorantraniliprole is considered adequate
for risk assessment and considered adequate for the characterization of
potential pre- and postnatal risks to infants and children.  The
chlorantraniliprole risk assessment team previously evaluated the
quality of the toxicity and exposure data and, based on these data,
recommended that the FQPA Safety Factor be reduced to 1x.  

Chlorantraniliprole/DPX-E2Y45 has no significant acute toxicity via the
oral, dermal, and inhalation routes of exposure.  The LD50 for oral and
dermal acute exposure is ≥5000 mg/kg/day and the LC50 for acute
inhalation exposure is ≥5.1 mg/L.  This substance is not an eye or
skin irritant and does not cause skin sensitization.  In short-term
studies, the most consistent effects are those associated with non
adverse pharmacological response to the xenobiotic, induction of liver
enzymes and subsequent increase in liver weights.  DPX-E2Y45 is not
genotoxic, neurotoxic, immunotoxic, carcinogenic, or teratogenic. 
Furthermore, it is not uniquely toxic to the conceptus as there were no
maternal or fetal effects in studies conducted in rats and rabbits. 
Based on the results of a 28-day dermal study in rats, as well as the
dermal LD50 study, DPX-E2Y45 has relatively low dermal toxicity.

Overall, chlorantraniliprole exhibits minimal mammalian toxicity after
long-term exposure.  The only consistent observation in the mammalian
toxicology studies is an increased degree of microvesiculation of the
adrenal cortex after dermal or dietary administration of
chlorantraniliprole.  Based on the lack of an adverse effect on the
function of the adrenal gland, this observation was considered treatment
related, but not “adverse.”

In addition to the adrenal effects, liver effects (e.g., increased liver
weight and induction of Cytochrome P450 enzymes) were reported in the
90-day oral subchronic studies across species and only at the highest
dose tested (>1000 mg/kg/day).  While in the subchronic studies, these
effects were considered adaptive, the liver effects were more pronounced
in the 18-month chronic mouse study at the highest dose tested. 
Increased eosinophilic foci (preneoplastic foci) were noted in male mice
at 935 mg/kg/day and liver hypertrophy and weight increase were evident
at the next lower dose (158 mg/kg/day), but progression to tumors was
not apparent for these effects.  Therefore, the eosinophilic foci appear
to be an adverse effect only seen in the highest dose tested and was
graded minimal in severity.

Dietary Exposure

The residue of concern in drinking water, plants and livestock for risk
assessment and tolerance enforcement is chlorantraniliprole (although
drinking water is not subject to tolerance enforcement).  Because
long-term oral exposure was the only route and duration where
chlorantraniliprole demonstrated toxicity (an adverse effect), only
chronic dietary (food and drinking water) exposure assessments were
conducted (using the dietary model DEEM-FCID).  The modeled exposure
estimates are based on tolerance level residues, assuming 100% of crops
associated with the Section 3 and 18 requests are treated, and include
the highest modeled EDWC relevant to the scenario.  Despite the
conservative assumptions on the exposure side, the resulting chronic
dietary exposures for all population subgroups were less than ≤1% of
the cPAD.

Non-Dietary, Non-Occupational Exposure

Residential exposure to chlorantraniliprole from existing uses is
expected.  The multitude of use sites, in addition to the persistence of
chlorantraniliprole, indicate there is potential for short- and
intermediate-term postapplication dermal (adults and children) and
incidental oral (children only) exposure to chlorantraniliprole
(inhalation exposure is not expected due to low vapor pressure). 
However, due to the lack of toxicity via the dermal route, as well as
the lack of toxicity over the acute, short- and intermediate-term
durations via the oral route, no risk is expected from these exposures.

Aggregate Risk

Although there is potential residential exposure, there is no
residential hazard/risk associated with the route/duration of the
proposed uses; therefore, aggregate exposure is comprised of food and
water only, and is considered in the dietary section of this document.

Occupational Exposure

There is a potential for occupational short- and intermediate-term
inhalation and dermal exposure to chlorantraniliprole during mixing,
loading, application and postapplication activities.  However, the
chlorantraniliprole toxicology database indicates there is no systemic
hazard associated with short- and intermediate-term dermal and
inhalation exposure, and therefore, no occupational exposure and risk
assessment was conducted.

In addition to systemic hazard, the Worker Protection Standard (WPS)
sets an REI based on the acute toxicity of chemicals.  Technical
chlorantraniliprole is in Category IV for acute dermal toxicity and
Category IV for primary eye and skin irritation.  Per the WPS, a 12-hr
REI is required for chemicals classified under Toxicity Category III or
IV.  However, the Section 18 label submitted for chlorantraniliprole
indicates a proposed REI of 4 hours.  According to Pesticide
Registration (PR) Notice 95-3, EPA permits registrants to reduce REIs
from 12 to 4 hours for certain low risk pesticides that meet certain
criteria.  Chlorantraniliprole meets all of the criteria listed in PR
Notice 95-3, and therefore, is a candidate for a reduced REI of 4 hours.
 The minimum level of PPE for handlers is based on acute toxicity for
the end-use product.  The Registration Division (RD) is responsible for
ensuring that PPE listed on the label is in compliance with the Worker
Protection Standard (WPS).

Conclusion

HED has no concerns regarding human health exposure and risk from the
proposed Section 18 use of chlorantraniliprole on sweet corn for control
of earworms.  HED recommends time-limited tolerances for residues of
chlorantraniliprole 

(3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chlo
ro-2-pyridinyl)-1H-pyrazole-5-carboxamide) be established in/on the
following raw agricultural commodities:

	K+CWHR ....................................0.01 ppm 

	Corn, sweet, forage .......................6.0 ppm

	Corn, sweet, stover ………………6.0 ppm

	Corn, sweet, cannery waste………6.0 ppm

	Milk……………………………. 0.03 ppm

NOTE:  There is an existing tolerance for milk associated with the
current Section 3 registrations.  The proposed S18 use on sweet corn
results in an increase in the livestock dietary burden and necessitates
an increase in the existing milk tolerance.  A temporary tolerance of
0.03 ppm is needed in association with the proposed Section 18 use on
sweet corn.

DETAILED DISCUSSION

Toxicological Considerations

The toxicology database for chlorantraniliprole is considered adequate
for risk assessment and considered adequate for the characterization of
potential pre- and postnatal risks to infants and children.  The
chlorantraniliprole risk assessment team previously evaluated the
quality of the toxicity and exposure data and, based on these data,
recommended that the FQPA Safety Factor be reduced to 1x.  

Chlorantraniliprole/DPX-E2Y45 has no significant acute toxicity via the
oral, dermal, and inhalation routes of exposure.  The LD50 for oral and
dermal acute exposure is ≥5000 mg/kg/day and the LC50 for acute
inhalation exposure is ≥5.1 mg/L.  This substance is not an eye or
skin irritant and does not cause skin sensitization.  In short-term
studies, the most consistent effects are those associated with non
adverse pharmacological response to the xenobiotic, induction of liver
enzymes and subsequent increase in liver weights.  DPX-E2Y45 is not
genotoxic, neurotoxic, immunotoxic, carcinogenic, or teratogenic. 
Furthermore, it is not uniquely toxic to the conceptus as there were no
maternal or fetal effects in studies conducted in rats and rabbits. 
Based on the results of a 28-day dermal study in rats, as well as the
dermal LD50 study, DPX-E2Y45 has relatively low dermal toxicity.

Overall, chlorantraniliprole exhibits minimal mammalian toxicity after
long-term exposure.  The only consistent observation in the mammalian
toxicology studies is an increased degree of microvesiculation of the
adrenal cortex after dermal or dietary administration of
chlorantraniliprole.  Based on the lack of an adverse effect on the
function of the adrenal gland, this observation was considered treatment
related, but not “adverse.”

In addition to the adrenal effects, liver effects (e.g., increased liver
weight and induction of Cytochrome P450 enzymes) were reported in the
90-day oral subchronic studies across species and only at the highest
dose tested (>1000 mg/kg/day).  While in the subchronic studies, these
effects were considered adaptive, the liver effects were more pronounced
in the 18-month chronic mouse study at the highest dose tested. 
Increased eosinophilic foci (preneoplastic foci) were noted in male mice
at 935 mg/kg/day and liver hypertrophy and weight increase were evident
at the next lower dose (158 mg/kg/day), but progression to tumors was
not apparent for these effects.  Therefore, the eosinophilic foci appear
to be an adverse effect only seen in the highest dose tested and was
graded minimal in severity.

Based on the weight of evidence of the available scientific data, and in
accordance with EPA’s Final Guidelines for Carcinogen Risk Assessment
(March 2005), chlorantraniliprole is classified as “Not Likely to Be
Carcinogenic to Humans”.

Dietary exposure via residues in/on food and drinking water are
aggregated in the chronic dietary assessment.  Aggregating routes and/or
pathways of exposure are not relevant for all other scenarios due to
lack of observed hazard for all other durations and exposure routes.

The toxicological doses (points of departure) and endpoints selected for
chlorantraniliprole are presented in the endpoint summary tables, i.e.,
Tables 1 and 2.

Table 1 Summary of Toxicological Doses and Endpoints for
Chlorantraniliprole for Use in Dietary and Non-Occupational Human Health
Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD,
Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary (All Populations)	N/A	N/A	N/A	No acute hazard,
attributable to a single dose, was identified; therefore, an acute
dietary endpoint was not selected for quantitative risk assessment.

Chronic Dietary (All Populations)	NOAEL= 158 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x	Chronic RfD = 1.58 mg/kg/day

cPAD = 1.58 mg/kg/day	18-Month Oral (feeding)/mouse

LOAEL = 935 mg/kg/day based on eosinophilic foci accompanied by
hepatocellular hypertrophy and increased liver weight (males only)

Incidental Oral Short-/Intermediate-Term 	N/A	N/A	N/A	There was no
hazard identified via the oral route over the short- and
intermediate-term and therefore, no endpoint was selected for
quantitative risk assessment.

Dermal Short-/Intermediate-Term 	N/A	N/A	N/A	There was no hazard
identified via the dermal route (and no concerns for developmental,
reproductive or neurotoxic effects) and therefore, no dermal endpoint
was selected for quantitative risk assessment.

Inhalation Short-/Intermediate-Term 	N/A	N/A	N/A	Based on the lack of
hazard identified in the acute inhalation study, lack of acute
irritation, and extremely low oral toxicity – no inhalation endpoint
was selected for quantitative risk assessment.

Cancer (oral, dermal, inhalation)	Classification:  “Not likely to be
Carcinogenic to Humans” based on weight of evidence of data: no
treatment-related tumors reported in the submitted chronic and
oncogenicity studies in rats and mice, subchronic studies in mice, dogs
and rats and that no mutagenic concern was reported in the genotoxicity
studies. 

Table 2  Summary of Toxicological Doses and Endpoints for
Chlorantraniliprole for Use in Occupational Human Health Risk
Assessments

Exposure/

Scenario	Point of Departure	Uncertainty Factors	Level of Concern for
Risk Assessment	Study and Toxicological Effects

Dermal Short-/Intermediate-Term 	N/A	N/A	N/A	There was no hazard
identified via the dermal route (and no concerns for developmental,
reproductive or neurotoxic effects) and therefore, no dermal endpoint
was selected for quantitative risk assessment.

Inhalation Short-/Intermediate-Term 	N/A	N/A	N/A	Based on the lack of
hazard identified in the acute inhalation study, lack of acute
irritation, and extremely low oral toxicity – no inhalation endpoint
was selected for quantitative risk assessment.

Cancer (dermal, inhalation)	Classification:  “Not likely to be
Carcinogenic to Humans” based on weight of evidence of data: no
treatment-related tumors reported in the submitted chronic and
oncogenicity studies in rats and mice, subchronic studies in mice, dogs
and rats and that no mutagenic concern was reported in the genotoxicity
studies. 

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).  FQPA SF = FQPA Safety Factor.  PAD = population
adjusted dose (c = chronic).  RfD = reference dose.  LOC = level of
concern.  N/A = not applicable

Residue Chemistry Considerations

Metabolism in Plants and Livestock

The nature of the residue in primary crops and rotational crops is
adequately understood.  In primary crops, chlorantraniliprole does not
metabolize to any great extent when applied as a foliar spray.  With up
to three consecutive foliar applications of chlorantraniliprole to
apples, tomatoes, and lettuce, and following a single application to
cotton, parent compound was the major component of the extracted
radioactivity in both human food and livestock feed items.  However,
when chlorantraniliprole was applied as a soil drench to rice crop, the
metabolism was demonstrated to be complex due to uptake from water
through roots, and numerous metabolites were identified in addition to
parent compound.   In rotational crops, the parent chlorantraniliprole
is the major component of the residue in following crops or succeeding
crops that were grown in soil previously treated with
chlorantraniliprole.  HED has determined that chlorantraniliprole is the
residue of concern in primary and rotational crop commodities for the
purposes of tolerance expression and risk assessment.

The nature of the residue in animals is adequately understood based on
acceptable ruminant and hen metabolism studies.  In the ruminant
metabolism study, parent was the major terminal residue identified in
kidney, muscle, and fat, and it was also a residue in liver and milk.
Metabolites were formed by N-demethylation, hydroxylation at the two
methyl groups, and/or cyclization to yield a pyrimidone ring.  In the
poultry study, chlorantraniliprole and its metabolites were eliminated
by the hen primarily in the excreta (>98% of the dose).  Parent was the
major residue in eggs and skin with fat, and was also detected in liver
and muscle.  The residue of concern in poultry and ruminant for
tolerance expression and risk assessment is chlorantraniliprole. 

Analytical Enforcement Methodology

The LC/MS/MS method, DuPont-11374, was used for data collection and
subsequently proposed as an enforcement method for plant commodities. 
Using this method, chlorantraniliprole is analyzed by LC/MS/MS operating
in the positive ionization mode.  The limit of quantification (LOQ) is
0.01 ppm for parent chlorantraniliprole.  The method for the
determination of chlorantraniliprole and its metabolites in processed
commodities is an LC/MS/MS method, DuPont-14314, which is a slightly
modified version of DuPont-11374.  

The proposed enforcement method for livestock commodities is an LC/MS/MS
method described in MRID 46889003.  Detection is by Atmospheric Pressure
Chemical Ionization (APCI) MS/MS operated in the positive ion mode.  The
LOQ is reported at 0.010 ppm for parent and each of the metabolites. 
The proposed plant and animal methods are adequate for tolerance
enforcement purposes (DP# 340358, C. Stafford, 2/6/08).

Chlorantraniliprole is not recovered by the U.S. FDA’s multi-residue
methods.  

Magnitude of the Residues

IR-4 is currently conducting a magnitude of the residue study to support
registration on sweet corn in the U.S. and Canada.  The field trials
were conducted in 2007.

Coragen 20SC was applied twice at 0.1 lb ai/A/application at a
retreatment interval of one day.  The PHI was also one day.  Field
trials were conducted in NY, NJ, MD, FL, AZ, WA, ND, WI, MI, OR in the
U.S., and Ontario (3 trials) and Alberta, Canada.  A brief summary of
the residue data that accompanied this Section 18 request is based on
the results for WA, Ontario (2 trials), FL, MD, ND, NJ, NY and WI.  

For K+CWHR residues were below the LOQ (0.01 ppm, N=18).  Residues in
treated forage samples (N=18) ranged from 0.94 ppm to 5.44 ppm.  All
control samples contained <0.01 ppm residues.  

Based on the above residue data, HED recommends time-limited tolerances
be established on K+CWHR at 0.01 ppm, sweet corn forage at 6.0 ppm,
sweet corn stover at 6.0 ppm, and cannery waste at 6.0 ppm.

Sweet corn stover (83% DM) may be fed to beef cattle (10% in the diet),
and sweet corn forage (48% DM) and cannery waste (30% DM) may be fed to
dairy cattle (20% and 10%, respectively).  The inclusion of sweet corn
forage (2.5 ppm) and cannery waste (2.0 ppm) in the dairy cattle diet
resulted in a much higher dietary burden (4.6 ppm) than beef cattle
(0.78 ppm).  The construction of reasonably balanced dietary burdens in
beef and dairy cattle reflects the most recent guidance from HED
(Personal communication, 5/7/08, J. Stokes).  

An adequate cattle feeding study is available.  Previously HED
recommended that tolerances at 0.01 ppm be established on milk, muscle,
fat, kidney and liver.  This Section 18 use on sweet corn could
potentially result in a significant increase in the dietary burden for
dairy cattle (from the previous estimate of 0.25 ppm to 4.6 ppm).  Given
the results of the cattle feeding study, HED recommends that the milk
tolerance be raised to 0.03 ppm, and the tolerances in muscle, fat,
kidney and liver remain unchanged at 0.01 ppm.

There are no poultry feeds associated with sweet corn commodities. 
Therefore, the poultry dietary burden previously calculated remains
unchanged and the original conclusion that tolerances for eggs and
poultry are not needed remains valid. 

Dietary (Food & Drinking Water) Exposure Analysis and Risk Estimates

Chronic exposure and risk estimates do not exceed HED’s level of
concern for the U.S. population.  Further, chronic exposure and risk
estimates do not exceed HED’s level of concern for all relevant
population subgroups (see Table 3). 

The chronic dietary analysis was based on tolerance level residues and
100% crop treated assumption for all commodities.  The drinking water
values used in the chronic dietary risk assessment were based on
information provided by the Environmental Fate and Effects Division
(DPBarcode 351273, T. Nguyen, et. al., 5/14/08).  Exposure to
chlorantraniliprole was higher in the surface water (3.65 ppb) than
ground water (1.06 ppb).  The surface drinking water residue of 3.65 ppb
was incorporated in the DEEM-FCID into the food categories “water,
direct, all sources” and “water, indirect, all sources”.  These
estimated drinking water concentration (EDWC) inputs cover the sweet
corn use pattern.

Table 3.  Chronic Dietary Exposure and Risk Estimates for
Chlorantraniliprole

Population Subgroup	cPAD, mg/kg/day	Chronic Estimates

(Food only)	Chronic Estimates

(Food and Drinking Water)

Exposure, mg/kg/day	Risk, % cPAD	Exposure, mg/kg/day	Risk, % cPAD

U.S. Population	1.58	0.007814	0.5	0.007891	<1.0

All infants

0.008110	0.5	0.008362	<1.0

Children 1-2 yrs

0.015594	1.0	0.015708	1.0

Children 3-5 yrs

0.012513	0.8	0.012620	<1.0

Children 6-12 yrs

0.008274	0.5	0.008348	<1.0

Youth 13-19 yrs

0.005963	0.4	0.006019	<1.0

Adults 20-49 yrs

0.007148	0.5	0.007220	<1.0

Adults 50+ yrs

0.007679	0.5	0.007754	<1.0

Females 13-49 yrs

0.007286	0.5	0.007357	<1.0

The population subgroup with the highest estimated exposure/risk is
bolded. 

Non-Dietary, Non-Occupational Exposure

Residential exposure to chlorantraniliprole from existing uses is
expected.  The multitude of use sites, in addition to the persistence of
chlorantraniliprole, indicate there is potential for short- and
intermediate-term postapplication dermal (adults and children) and
incidental oral (children only) exposure to chlorantraniliprole
(inhalation exposure is not expected due to low vapor pressure). 
However, due to the lack of toxicity via the dermal route, as well as
the lack of toxicity over the acute, short- and intermediate-term via
the oral route – no risk is expected from these exposures.

Aggregate Risk

Although there is potential residential exposure, there is no
residential hazard/risk associated with the route/duration of the
proposed uses; therefore, aggregate exposure is comprised of food and
water only, and is considered in the dietary section of this document.

Occupational Considerations

There is a potential for occupational short- and intermediate-term
inhalation and dermal exposure to chlorantraniliprole during mixing,
loading, application and postapplication activities.  However, the
chlorantraniliprole toxicology database indicates there is no systemic
hazard associated with short- and intermediate-term dermal and
inhalation exposure, and therefore, no occupational exposure and risk
assessment was conducted.

In addition to systemic hazard, the Worker Protection Standard (WPS)
sets an REI based on the acute toxicity of chemicals.  Technical
chlorantraniliprole is in Category IV for acute dermal toxicity and
Category IV for primary eye and skin irritation.  Per the WPS, a 12-hr
REI is required for chemicals classified under Toxicity Category III or
IV.  However, the Section 18 label submitted for chlorantraniliprole
indicates a proposed REI of 4 hours.  According to Pesticide
Registration (PR) Notice 95-3, EPA permits registrants to reduce REIs
from 12 to 4 hours for certain low risk pesticides that meet certain
criteria.  Chlorantraniliprole meets all of the criteria listed in PR
Notice 95-3, and therefore, is a candidate for a reduced REI of 4 hours.
 The minimum level of PPE for handlers is based on acute toxicity for
the end-use product.  The Registration Division (RD) is responsible for
ensuring that PPE listed on the label is in compliance with the Worker
Protection Standard (WPS).

Cumulative Risk

 hž

␃༂킄⸂⼀㄀$♀帀킄愂Ȥ摧捷T

 

6

U

V

h

z

¬

Ì

ë

ì

í

T

Y

ê

ë

—

°

Ñ

hi

hi

h‘

h‘

gdi

gdi

gdi

Ò

a$gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

gdi

)epa.gov/pesticides/cumulative/. 

Conclusion

HED has no concerns regarding human health exposure and risk from the
proposed Section 18 use of chlorantraniliprole on sweet corn for control
of earworms.  HED recommends time-limited tolerances for residues of
chlorantraniliprole 

(3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chlo
ro-2-pyridinyl)-1H-pyrazole-5-carboxamide) be established in/on the
following raw agricultural commodities:

	K+CWHR ....................................0.01 ppm 

	Corn, sweet, forage .......................6.0 ppm

	Corn, sweet, stover ………………6.0 ppm

	Corn, sweet, cannery waste………6.0 ppm

	Milk……………………………. 0.03 ppm

Page   PAGE  9  of   NUMPAGES  11