UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Date: 

Subject: 

WASHINGTON, D.C. 20460 

February 28, 20 13 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Cyantraniliprole. Occupational and Residential Exposure and Risk Assessment 

for the Proposed New Uses of the New Active Insecticide, including Agricultural 

Uses on Brassica (Cole) Leafy Vegetables (Group 5), Bulb Vegetables (Group 3-

07), Bushberries (Group 13-07B), Citrus Fruit (Group I 0-10), Cotton, Cucurbit 

Vegetables (Group 9), Fruiting Vegetables (Group 8-10), Leafy Vegetables (nonBrassica) (Group 4), Oilseeds (Group 20), Pome Fruits (Group 11-1 0), Stone 

Fruits (Group 12), Tree Nuts (Group 14), Tuberous and Corm Vegetables 

(Subgroup 1 C); Seed Treatment Uses on Canola, Mustard Seed, Sunflowers, and 

Potatoes; and Residential, Commercial, and Agricultural Uses on Ornamentals, 

Turfgrass (including Sod Farms), and Structural Buildings (including Indoor 

Crack/Crevice and Outdoor Broadcast). 

PC Code: 090098 DP Barcode: 0407964 

Registration Nos.: 352-IAE, 352-IAG, 352-IAI, 352-IAL, 253-IAN, 352- Decision No.: 451670 

ILA, 352-ILI, 352-ILO, 352-ILT, 100-RUEE, 100-RUEG, 100-RUEN, 

100-RUER, 100-RUEU, 100-RURI 

Petition No.: I F7894 

Risk Assessment Type: OccupationaVResidential Exposure Assessment 

TXR No.: NA 

MRID No.: NA 

From: Nancy J. Tsaur, Chemist 

Risk Assessment Branch 3 (RAB 

Health Effects Division (7509P) 

Regulatory Action: Section 3 

Case No.: NA 

CAS No.: 736994-63-1 

40 CFR: to be determined 

Through: Barry 

Risk Assessment 

O'Keefe, Senior 

Branch 

Biologist, 

3 (RAB3) 

ORE Team Leader .B. 0 ~ 

Health Effects Division (7509P) 

and ttL 

Wade Britton, Biologist 'M/,( I 11 

Matthew Crowley, Senior Bt agist, E:::I!i Co-Chair 

Exposure Science Advisory Committee (ExpoSAC) 

Health Effects Division (7509P) 

To: Thomas Harris/John Hebert, RM #07 

Insecticide Rodenticide Branch (IRB) 

Division (7505P) 

Page 1 of 47 
Introduction 

t ·-· 

The Registration Division (RD) requested that the Health Effects Division (HED) conduct an 

occupational and residential exposure and risk assessment for all of the proposed new uses of the 

new active insecticide, cyantraniliprole, including agricultural uses on Brassica (Cole) leafy 

vegetables (Group 5), bulb vegetables (Group 3-07), bushberries (Group 13-07B), citrus fruits 

(Group 1 0-10), cotton, cucurbit vegetables (Group 9), fruiting vegetables (Group 8-1 0), leafy 

vegetables (non-Brassica) (Group 4), oilseeds (Group 20), pome fruits (Group 11-10), potatoes, 

stone fruits (Group 12), sunflowers, tree nuts (Group 14), tuberous and corm vegetables 

(Subgroup I C); seed treatment uses on canola, mustard seed, sunflowers, and potatoes; and 

residential, commercial, and agricultural uses on ornamentals, turfgrass (including sod farms), 

and structural buildings (including indoor crack/crevice and outdoor broadcast). 

It is HED policy to use the best available data to assess exposure. Several sources of generic 

data were used in this assessment as surrogate data in the absence of chemical-specific data, 

including Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1 ); the Agricultural 

Handler Exposure Task Force (AHETF) database; the Outdoor Residential Exposure Task Force 

'(ORETF) database; ExpoSAC Policy 14 (SOPs for Seed Treatment); the Residential SOPs 

(Lawns/Turf; Gardens and Trees; Indoor Environments). Some ofthese data are proprietary, and 

subject to the data protection provisions of the Federal Insecticide, Fungicide, and Rodenticide 

Act (FIFRA). 

Note: This memorandum was reviewed by the Exposure Science Advisory Committee 

(ExpoSAC) on January 17, 2013. 

: i: 

Page 2 of 47 
Page 3 of 47

Table of Contents

1.0 Executive Summary............................................................................................................. 4

2.0 Risk Assessment Conclusions and Recommendations........................................................ 6

2.1 Summary of Risk Estimates............................................................................................. 6

2.2 Label Recommendations from Occupational Assessment............................................... 6

2.3 Label Recommendations from Residential Assessment .................................................. 7

2.4 Data Deficiencies and Requirements ............................................................................... 7

3.0 Hazard Characterization....................................................................................................... 7

4.0 Use Profile ......................................................................................................................... 11

5.0 Residential Exposure and Risk Estimates.......................................................................... 19

5.1 Residential Handler Exposure/Risk Estimates............................................................... 19

5.2 Residential Post-Application Exposure/Risk Estimates................................................. 22

5.3 Residential Risk Estimates for Use in Aggregate Assessment ...................................... 25

5.4 Spray Drift...................................................................................................................... 26

5.5 Residential Bystander Post-Application Inhalation Exposure ....................................... 26

6.0 Occupational Exposure and Risk Estimates ...................................................................... 27

6.1 Agricultural Occupational Handler Exposure/Risk Estimates....................................... 27

6.2 Seed Treatment Occupational Handler Exposure/Risk Estimates ................................. 34

6.3 Occupational Post-Application Exposure/Risk Estimates ............................................. 38

6.4 Restricted Entry Interval ................................................................................................ 39

Appendix A. Summary of Occupational Handler Non-Cancer Algorithms................................ 41

Appendix B. Summary of Residential Post-Application Non-Cancer Algorithms ..................... 42

Appendix C. Human Equivalent Concentrations and Human Equivalent Dose Calculations . 45
Page 4 of 47

1.0 Executive Summary

Cyantraniliprole is a new second-generation ryanodine receptor (RyR) insecticide currently 

undergoing global joint review. It has been jointly developed by DuPont and Syngenta, with a 

proposal (PP#1F7894) for one technical product and 14 U.S. end-use product (EP) registrations, 

including agricultural food-uses. 

Cyantraniliprole is a systemic insecticide belonging to the diamide class of chemistry, mobile in 

both the xylem and phloem. The mode of action is through its binding with insect RyRs. This 

causes muscle contraction, which leads to paralysis and eventual death of the insect.

Proposed Use Profile

The agricultural uses include foliar, soil, and seed treatment to various crops including cotton, 

fruits, oilseeds, and vegetables. The residential use sites include turfgrass, ornamentals, and 

structural buildings (including indoor crack/crevice and outdoor broadcast).

Exposure Profile

Non-occupational and occupational exposures to cyantraniliprole are expected for short- and 

intermediate-term durations. The dermal route of exposure is not assessed because there is no

dermal hazard. The proposed residential uses (turf, ornamentals, and indoor crack/crevice) result 

in inhalation exposures for adults (handlers) and post-application incidental oral exposures for 

children (1 to <2 years old).

Hazard Characterization

The toxicity data indicate that cyantraniliprole produces liver effects at lower dose levels. Dogs 

appear to be more sensitive than rats and mice. A dermal point of departure (POD) is not chosen 

because systemic toxicity is not seen in 28-day dermal toxicity in rats at the limit dose (1,000 

mg/kg/day). The short- and intermediate-term inhalation PODs are based on the results of a 28-

day inhalation toxicity study in rats. To determine the inhalation PODs for residential and 

occupational exposure, the Agency’s Reference Concentration (RfC) methodology is used to 

calculate human equivalent concentrations (HECs). The HECs are then converted to respective 

human equivalent doses: NOAEL = 7.2 mg/kg/day for residential exposure and NOAEL = 10.08 

mg/kg/day for occupational exposure. The short- and intermediate-term incidental oral POD is

based on two co-critical studies: the 28-day and 90-day oral toxicity studies in dogs (NOAEL = 

3.0 mg/kg/day). Cyantraniliprole is not acutely toxic; it is classified as Toxicity Category IV for 

all routes of exposure (dermal, oral, and inhalation). There are no genotoxicity, mutagenicity, 

neurotoxicity, or immunotoxicity concerns. Nor are there developmental or reproductive toxicity 

concerns. Cyantraniliprole is classified as “Not Likely to be Carcinogenic to Humans” based on 

the absence of increased tumor incidence in acceptable/guideline carcinogenicity studies in rats 

and mice.

Combining Exposures/Risk Estimates

The dermal route of exposure does not need to be combined with another route of exposure or 

included in the aggregate risk assessment because there is no dermal hazard.
Page 5 of 47

Summary of Residential Handler Non-Cancer Exposure and Risk Estimates

Handler risk estimates for all scenarios are not of concern. Short-term inhalation MOEs range 

from 22,000 to 220,000,000.

Summary of Residential Post-Application Non-Cancer Exposure and Risk Estimates

Although residential dermal exposure is expected following the treatment of turf or 

cracks/crevices, a quantitative post-application dermal risk assessment was not conducted

because a dermal hazard was not identified for cyantraniliprole. Short-term incidental oral postapplication risk estimates (which are protective of intermediate-term risk estimates) for all 

scenarios are not of concern to HED (MOEs range from 290 to 1,000,000).

Summary of Aggregate

The most protective risk estimate for adult handler inhalation exposures is based on dry flowable 

application to ornamentals which results in an MOE of 22,000. The most protective risk 

estimate for children’s post-application incidental oral exposures is based on indoor liquid 

crack/crevice application to carpets which results in an MOE of 290.

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates

The results of the occupational handler exposure and risk assessment indicate that short- and 

intermediate-term inhalation risks are not of concern at baseline mitigation without personal 

protective equipment (PPE). Short- and intermediate-term MOEs range from 1,200 to 

3,900,000. Note that only engineering control (enclosed cockpit) data are available to assess 

risks to handlers operating aircrafts. Seed treatment MOEs range from 370 to 4,000 for primary 

handlers (treaters) and 2,200 to 190,000 for secondary handlers (planters).

Summary of Occupational Post-Application Non-Cancer Exposure and Risk Estimates

An occupational post-application dermal exposure and risk assessment was not conducted 

because a dermal hazard was not identified for cyantraniliprole. Based on the Agency's current 

practices, a quantitative non-cancer occupational post-application inhalation exposure 

assessment was not performed for cyantraniliprole at this time. If new policies or procedures are 

put into place, the Agency may revisit the need for a quantitative occupational post-application 

inhalation exposure assessment for cyantraniliprole.

Restricted Entry Interval

The technical form of cyantraniliprole meets the criteria for a 4-hour REI. However, two of the 

proposed EPs (EPA Reg. No. 352-ILT and EPA Reg. No. 352-ILI) have been identified as 

dermal sensitizers, so a 12-hour REI is required to protect agricultural workers from postapplication exposures to cyantraniliprole. Aside from these two products, a 4-hour REI is

adequate to protect agricultural workers from post-application exposures to cyantraniliprole.

Human Studies Review

This risk assessment relies in part on data from studies in which adult human subjects were 

intentionally exposed to a pesticide or other chemical. These data, which include Pesticide 

Handlers Exposure Database Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task 

Force (AHETF) database; the Outdoor Residential Exposure Task Force (ORETF) database;

ExpoSAC Policy 14 and 15.1 (SOPs for Seed Treatment); the Residential SOPs (Lawns/Turf; 
Page 6 of 47

Gardens and Trees; Indoor Environments), are (1) subject to ethics review pursuant to 40 CFR 

26, (2) have received that review, and (3) are compliant with applicable ethics requirements. For 

certain studies, the ethics review may have included review by the Human Studies Review 

Board. Descriptions of data sources, as well as guidance on their use, can be found at the 

Agency website1. 

2.0 Risk Assessment Conclusions and Recommendations

There are no occupational/residential risk estimates of concern associated with the proposed new 

uses of cyantraniliprole. 

2.1 Summary of Risk Estimates

Occupational Exposure and Risk Estimates

The results of the occupational handler exposure and risk assessment indicate that short- and 

intermediate-term inhalation risks do not exceed HED’s level of concern (i.e. the LOC is an 

MOE < 30 for short-term exposures and an MOE < 100 for intermediate-term exposures) at 

baseline mitigation (no PPE). Since the short- and intermediate-term PODs are the same, the 

inhalation MOEs are also the same, ranging from 1,200 to 3,900,000. Dermal handler and postapplication exposure and risk assessments were not conducted because a dermal hazard was not 

identified for cyantraniliprole.

Residential Exposure and Risk Estimates

The results of the residential handler exposure and risk assessment indicate that short-term 

inhalation risks do not exceed HED’s LOC (i.e. an MOE < 30). Handler risk estimates for all 

scenarios are not of concern. Short-term inhalation MOEs range from 22,000 to 220,000,000.

Although residential dermal exposure is expected following the treatment of turf or 

cracks/crevices, a quantitative post-application dermal risk assessment was not conducted 

because a dermal hazard was not identified for cyantraniliprole. Short-term incidental oral postapplication risk estimates for all scenarios are not of concern to HED (MOEs range from 290 to 

1,000,000) because they exceed the LOC for incidental oral exposure (i.e. an MOE < 100). 

Furthermore, short-term incidental oral post-application risk estimates are protective of 

intermediate-term because the POD is the same.

2.2 Label Recommendations from Occupational Assessment 

The labeled use pattern for EPA Reg. No. 352-IAG must be clarified. The proposed label states 

both: “For vegetable transplants in and around greenhouses,” as well as “Do not apply to 

greenhouse or field grown vegetables, only apply to vegetable transplants grown in enclosed 

structures.” Note that both use patterns have been considered in this risk assessment and neither 

would result in occupational risk estimates of concern.

 

1

http://www.epa.gov/pesticides/science/handler-exposure-data.html and 

http://www.epa.gov/pesticides/science/post-app-exposure-data.html
Page 7 of 47

2.3 Label Recommendations from Residential Assessment

There are no label recommendations based on the residential assessment.

2.4 Data Deficiencies and Requirements

There are no data deficiencies or data requirements for the new active ingredient, 

cyantraniliprole.

3.0 Hazard Characterization

Cyantraniliprole belongs to the anthranilic diamide class of pesticides. Anthranilic diamides

control insects through unregulated activation of RyR channels leading to internal calcium store 

depletion that impairs regulation of muscle contraction. Insects exposed to anthranilic diamides

exhibit general lethargy and muscle paralysis ultimately followed by death.

The risk assessment for cyantraniliprole is based on a well-characterized and complete 

toxicology database. While unregulated activation of RyR channels leads to insect death, the 

insect RyR are shown to be 350 to >2500 times more sensitive than those of mammals. In 

general, cyantraniliprole administration produces both adverse and adaptive changes in the liver, 

thyroid gland, and adrenal cortex. With repeated dosing, consistent findings of mild to moderate 

increases in liver weights across multiple species (rats, mice, dogs) are observed. Dogs appear to 

be more sensitive than rats and mice; cyantraniliprole produces adverse liver effects (increases in 

alkaline phosphatase, decreases in cholesterol, and decreases in albumin) in dogs at lower dose 

levels than in rats. In addition, the liver effects in the dog show progressive severity with 

increased duration of exposure. The available data also show thyroid hormone homeostasis is 

altered in rats following exposure to cyantraniliprole after 28 or 90 days. However, 

cyantraniliprole is not a direct thyroid toxicant.

A dermal point of departure (POD) is not chosen because systemic toxicity is not seen in 28-day 

dermal toxicity in rats at the limit dose (1,000 mg/kg/day). The short- and intermediate-term 

incidental oral POD is based on two co-critical studies: the 28-day and 90-day oral toxicity 

studies in dogs (NOAEL = 3.0 mg/kg/day). The short- and intermediate-term inhalation PODs 

are based on the results of a 28-day inhalation toxicity study in rats (NOAEL = 10.08 mg/kg/day 

for occupational exposure, NOAEL = 7.2 mg/kg/day for residential exposure). 

To determine the inhalation PODs for residential and occupational exposure, the Agency’s 

Reference Concentration (RfC) methodology was used to calculate human equivalent 

concentrations (HECs). These calculations are detailed in Appendix B, Section B.4. The HECs 

are based on a 28-day rat inhalation study which show no systemic or port of entry effects at the 

highest concentration (NOAEL = 0.1 mg/L). Because the 28-day study was conducted 6 hours 

per day, 5 days per week, the HECs are adjusted to represent both residential and occupational 

exposure scenarios. For residential exposure, the HEC is adjusted to represent continual 

exposure for 24 hours per day, 7 days per week. For occupational exposure, the HEC was 

adjusted to represent an average work week for 8 hours per day, 5 days per week. The shortterm inhalation HEC of 0.21 mg/L calculated for residential exposures is then converted to a 
Page 8 of 47

human equivalent dose NOAEL of 7.2 mg/kg/day to allow for comparison to estimated 

residential inhalation doses (which are in units mg/kg/day). The short- and intermediate-term 

inhalation HEC of 0.05 mg/L calculated for occupational exposures was also converted to a 

human equivalent dose NOAEL of 10.08 mg/kg/day to allow for comparison to estimated 

occupational inhalation doses (which are in units mg/kg/day).

Although a route specific 28-day inhalation study is used to establish the intermediate-term POD, 

some of the toxicity data indicate a progression in toxicity with time. The data indicate an 

approximate three-fold difference in the LOAEL between a 28-day oral toxicity study in rats (53 

mg/kg/day) and a reproduction study in rats (14 mg/kg/day). Therefore, an uncertainty factor of 

3X is selected to account for using a POD from a short-term 28-day day inhalation study to 

assess intermediate-term exposure (1- 6 months). Given that the 28-day inhalation study does 

not show any adverse effects at the highest concentration, HED acknowledges that the 

application of 3X is a conservative approach. However, given the progression of liver effects 

seen in oral studies, HED cannot rule out the potential for adverse port of entry or systemic 

effects given longer exposures.

In accordance with the requirements of the FQPA (1996), HED has considered the potential for 

concurrent cyantraniliprole exposure via oral, dermal, and inhalation routes. HED aggregates 

exposure from different routes for each population if the same toxic effects are seen for that 

duration of exposure by each route. The dermal route of exposure does not need to be combined 

with another route of exposure or included in the aggregate risk assessment because there is no 

identified dermal hazard. There are no genotoxicity, mutagenicity, neurotoxicity, or 

immunotoxicity concerns. Nor are there developmental or reproductive toxicity concerns. 

Cyantraniliprole is classified as “Not Likely to be Carcinogenic to Humans” based on the 

absence of increased tumor incidence in acceptable/guideline carcinogenicity studies in rats and 

mice.

Acute Toxicity

Table 3.1. Summary of Acute Toxicity Data for Cyantraniliprole (Technical Active Ingredient)

Type of study MRID Results Toxicity 

Category

Acute oral LD50—mouse 48119957 LD50 >5000 mg/kg IV

Acute oral LD50—rat 48119952 LD50 >5000 mg/kg IV

Acute dermal LD50—rat 48119953 LD50 >5000 mg/kg IV

Acute inhalation LC50 (4 hr)—rat 48119958 LC50 >5.2 mg/L IV

Skin irritation—rabbit 48119954 Not irritating

NA

Eye irritation—rabbit 48119955 Slightly irritating; clearing by 72 

hours

Eye irritation—rabbit 48208421 Not irritating

Skin sensitisation—mouse

(local lymph node assay) 48208422 Not sensitizing

Skin sensitisation—mouse

(local lymph node assay) 48208423 Not sensitizing

Skin sensitisation—guinea pig

(Maximisation test) 48119984 Not Sensitizing
Page 9 of 47

Toxicological PODs Used for Risk Assessment

Table 3.2. Summary of Toxicological Doses and Endpoints for Cyantraniliprole for Use in NonOccupational/Residential Human Health Risk Assessmentsa

Exposure/ 

Scenario

Point of 

Departure

Uncertainty/

FQPA Safety 

Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological Effects

Acute 

Dietary 

(General 

Population, 

including 

Infants and 

Children 

and 

Females 13-

49 years of 

age)

An effect attributed to a single dose was not identified in the toxicology database. 

Incidental 

Oral

Short-Term 

(1-30 days)

and 

Intermediate

-Terms (1-6 

months)

NOAEL = 

3 

mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 

1X

LOC = 100

28-day and 90-day oral study in dogs.

28-day LOAEL = 35 mg/kg/day (lowest dose 

tested) based on decreases in body weight, food 

consumption, food efficiency, and changes in 

clinical chemistry (↑ALP, ↓ cholesterol and ↓ 

albumin).

90-day LOAEL = 32 mg/kg/day based on a 

collection of treatment-related effects indicative of 

liver toxicity. The effects included decreases in total 

protein, albumin, and cholesterol in males and 

females; increases in alkaline phosphatase in males 

and females; increases in alanine aminotransferase 

in females; and increases in liver weights in males 

and females. 

Dermal 

Short-Term 

(1-30 days)

A toxicity endpoint was not identified.

Systemic toxicity was not seen in 28-day dermal toxicity in rats at the limit dose (1000 

mg/kg/day). There are no concerns for developmental or reproductive toxicity or neurotoxicity.

Inhalation 

Short-Term 

(1-30 days) 

NOAEL =

0.1 mg/L UFA = 3X

b

UFH = 10X

FQPA SF = 

1X

LOC = 30

28-day inhalation toxicity study in rats.

A LOAEL was not established because the highest 

concentration tested (0.1 mg/L) did not demonstrate 

any adverse portal of entry or systemic effects.

HEC =

0005 mg/L

HED = 7.2

mg/kg/day

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not likely to be Carcinogenic to Humans” based on data showing lack of

treatment-related increase in tumor incidence in the rat and mouse carcinogenicity studies. 

Mutagenic concern was not reported in the mutagenicity studies.

a 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. LOC = level of concern. HED = human equivalent dose. HEC =

human equivalent concentration.

b The magnitude of the UFs applied is dependent on the methodology used to calculate risk. The RfC methodology takes into 

consideration the pharmacokinetic (PK) differences, but not the pharmacodynamic (PD) differences. Consequently, the UF for 

interspecies extrapolation may be reduced to 3X (to account for the PD differences).
Page 10 of 47

Table 3.3. Summary of Toxicological Doses and Endpoints for Cyantraniliprole for Use in Occupational 

Human Health Risk Assessmentsa

Exposure/ 

Scenario

Point of 

Departure

Uncertainty/

FQPA Safety 

Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological Effects

Dermal 

Short-Term 

(1-30 days) 

and 

Intermediate

-Terms (1-6 

months)

A toxicity endpoint was not identified.

Systemic toxicity was not seen in 28-day dermal toxicity in rats at the limit dose (1000 

mg/kg/day). There are no concerns for developmental or reproductive toxicity or neurotoxicity.

Inhalation 

Short-Term 

(1-30 days) 

NOAEL = 

0.1 mg/L

UFA = 3Xb

UFH = 10X LOC = 30

28-day inhalation toxicity study in rats.

A LOAEL was not established because the highest 

concentration tested (0.1 mg/L) did not demonstrate 

any adverse portal of entry or systemic effects.

HEC = 

0.05 mg/L

HED = 

10.08 

mg/kg/day

Inhalation 

Intermediate

-Term (1-6 

months)

NOAEL = 

0.1 mg/L

UFA = 3X

UFH = 10X

UFDB = 3Xc

LOC = 100

28-day inhalation toxicity study in rats.

A LOAEL was not established because the highest 

concentration tested (0.1 mg/L) did not demonstrate 

any adverse portal of entry or systemic effects.

HEC = 

0.05 mg/L

HED = 

10.08

mg/kg/day

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not likely to be Carcinogenic to Humans” based on data showing lack of

treatment-related increase in tumor incidence in the rat and mouse carcinogenicity studies. 

Mutagenic concern was not reported in the mutagenicity studies.

a 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. HED = human equivalent dose. 

HEC = human equivalent concentration. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). 

UFH = potential variation in sensitivity among members of the human population (intraspecies). UFDB = database uncertainty 

factor: use of a short-term study for intermediate-term risk assessment. FQPA SF = FQPA Safety Factor. LOC = level of 

concern.

b The magnitude of the UFs applied is dependent on the methodology used to calculate risk. The RfC methodology takes into 

consideration the pharmacokinetic (PK) differences, but not the pharmacodynamic (PD) differences. Consequently, the UF for 

interspecies extrapolation may be reduced to 3X (to account for the PD differences).

c A route specific 28-day inhalation study is used to establish the intermediate term exposure toxicity endpoint and point of 

departure. Some of the toxicity data on cyantraniliprole indicate that there was a progression in toxicity with time. The data 

indicate a ~three-fold difference in the LOAEL between a 28-day oral toxicity study in rats (53 mg/kg/day) and a reproduction 

study in rats (14 mg/kg/day). Therefore, an uncertainty factor of 3X was selected to account for using a POD from a short-term 

28-day day inhalation study to assess intermediate-term exposure (1- 6 months).

Absorption

A dermal absorption factor is not used in this assessment because a dermal toxicity POD is not 

identified based on a 28-day dermal toxicity study in rats. Since the short- and intermediate-term 

inhalation PODs are based on a route-specific toxicity study, absorption factors are not necessary 

to estimate inhalation exposure.
Page 11 of 47

Body Weight

The standard body weight for the general population (80 kg) is used for all adult exposure 

scenarios covered in this risk assessment since the endpoints selected are not developmental 

and/or fetal effects. The standard body weight for children 1 to <2 years old is 11 kg.

4.0 Use Profile

Table 4.1. Summary of Proposed Directions for Use of Cyantraniliprole (DuPont and Syngenta Labels)

Application 

Timing, Type, and 

Equipment

Formulation

[EPA Reg. No.]

Trade Namea

Maximum 

Application 

Rate

Max. No. 

of

Apps per

Season

Max. 

Seasonal 

Application 

Rate

RTI Use Directions and Limitations

days

Brassica (Cole) Leafy Vegetables (Group 5)

Soil at Planting

(in-furrow spray, 

transplant water 

treatment, hill drench, 

surface band, soil 

shank injection)

18.66% SC

[352-IAN]

VerimarkTM

0.176

lb ai/A

0.00202

lb ai/gal

1

0.176

lb ai/A N/A

Only to be applied to the soil by ground or drip 

chemigation application equipment. Must be 

applied uniformly in the root zone. Do not make 

aerial or airblast applications. Do not treat plants 

being grown for transplanting in nurseries. Use 

this product only in commercial and farm 

plantings. May be used on crops grown for seed 

production.

Foliar

(ground, aerial)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S

0.4

lb ai/A

5

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates; non-ionics; organosilicones/

organosilicates). Use a minimum of 10 gallons 

per acre for all vegetable crops.

Soil

(in-furrow spray at 

seeding or 

transplanting; post 

seeding, post 

transplant, hill 

drench; drip 

(trickle) 

chemigation; 

shanked into root 

zone)

20.0% WG

[100-RUER]

A16901B CP

0.175

lb ai/A

0.0175

lb ai/gal

1 NA

Use this product only in commercial and farm 

plantings. Do not use in greenhouses. Do not 

treat plants grown for transplanting. Apply 

within 21 days of planting or transplanting. 

Make only one soil application per growing 

season.

Foliar

(ground, aerial, 

chemigation)

20.0% WG

[100-RUER]

A16901B CP

0.0875

lb ai/A

0.00875

lb ai/gal

N/S 7

Use this product only in commercial and farm 

plantings. Do not use in greenhouses. Do not 

treat plants grown for transplanting. Apply 

within 21 days of planting or transplanting. Use 

a minimum of 10 gal water per acre for ground 

application.

Bulb Vegetables (Group 3-07)

Foliar

(ground, aerial)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S 0.4

lb ai/A 5

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates; non-ionics; organosilicones/

organosilicates). Use a minimum of 10 gallons 

per acre for all vegetable crops.
Page 12 of 47

Table 4.1. Summary of Proposed Directions for Use of Cyantraniliprole (DuPont and Syngenta Labels)

Application 

Timing, Type, and 

Equipment

Formulation

[EPA Reg. No.]

Trade Namea

Maximum 

Application 

Rate

Max. No. 

of

Apps per

Season

Max. 

Seasonal 

Application 

Rate

RTI Use Directions and Limitations

days

Foliar

(ground, aerial, 

chemigation)

10.26% OD

[352-ILT]

BeneviaTM

0.133

lb ai/A

0.0133

lb ai/gal

N/S 0.4

lb ai/A 5

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates; non-ionics; organosilicones/

organosilicates). Use a minimum of 10 gallons 

per acre for bulb vegetables.

Bushberries (Group 13-07B)

Foliar

(ground, aerial)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S 0.4

lb ai/A 5

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates; non-ionics; organosilicones/

organosilicates). Use a minimum of 30 gallons 

per acre for all fruit and nut crops.

Citrus Fruits (Group 10-10)

Soil drench or 

microsprinkler 

chemigation

18.66% SC

[352-IAN]

VerimarkTM

0.391

lb ai/A

0.00449

lb ai/gal

1

0.4

lb ai/A N/A

For use on citrus nursery stock (trees less than 4 

years old). Only to be applied to the soil by 

ground or drip chemigation application 

equipment. Must be applied uniformly in the 

root zone. Do not make aerial or airblast 

applications. Do not treat plants being grown 

for transplanting in nurseries. Use this product 

only in commercial and farm plantings. May be 

used on crops grown for seed production.

Foliar

(ground, aerial)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S 0.4

lb ai/A 7

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates; non-ionics; organosilicones/

organosilicates). Use a minimum of 30 gallons 

per acre for all fruit and nut crops.

Cotton

Foliar

(ground, aerial)

10.26% OD

[352-ILT]

BeneviaTM

0.133

lb ai/A

0.0133

lb ai/gal

N/S 0.4

lb ai/A 7

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates; non-ionics; organosilicones/

organosilicates). Use a minimum of 10 gallons 

per acre for cotton.
Page 13 of 47

Table 4.1. Summary of Proposed Directions for Use of Cyantraniliprole (DuPont and Syngenta Labels)

Application 

Timing, Type, and 

Equipment

Formulation

[EPA Reg. No.]

Trade Namea

Maximum 

Application 

Rate

Max. No. 

of

Apps per

Season

Max. 

Seasonal 

Application 

Rate

RTI Use Directions and Limitations

Cucurbit Vegetables (Group 9)

Soil at Planting

(in-furrow spray, 

transplant water 

treatment, hill drench, 

surface band, soil 

shank injection)

18.66% SC

[352-IAN]

VerimarkTM

0.176

lb ai/A

0.00202

lb ai/gal

1

0.176

lb ai/A N/A Only to be applied to the soil by ground or drip 

chemigation application equipment. Must be 

applied uniformly in the root zone. Do not

make aerial or airblast applications. Do not treat 

plants being grown for transplanting in 

nurseries. Use this product only in commercial 

and farm plantings. May be used on crops 

Drip grown for seed production. chemigation

18.66% SC 

[352-IAN]

VerimarkTM

0.130

lb ai/A

0.00149

lb ai/gal

2

(1 if atplant 

app is 

made)

0.260

lb ai/A 10

Foliar

(ground, aerial)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S 0.4

lb ai/A 1

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates; non-ionics; organosilicones/

organosilicates). Use a minimum of 10 gallons 

per acre for all vegetable crops.

Soil

(in-furrow spray at 

seeding or 

transplanting; post 

seeding, post 

transplant, hill 

drench; drip 

(trickle) 

chemigation; 

shanked into root 

zone)

20.0% WG

[100-RUER]

A16901B CP

0.175

lb ai/A

0.0175

lb ai/gal

1

0.4

lb ai/A NA

Use this product only in commercial and farm 

plantings. Do not use in greenhouses. Do not 

treat plants grown for transplanting. Apply 

within 21 days of planting or transplanting. 

Make only one soil application per growing 

season.

Foliar

(ground, aerial, 

chemigation)

20.0% WG

[100-RUER]

A16901B CP

0.0875

lb ai/A

0.00875

lb ai/gal

N/S 0.4

lb ai/A 7

Use this product only in commercial and farm 

plantings. Do not use in greenhouses. Do not 

treat plants grown for transplanting. Apply 

within 21 days of planting or transplanting. 

Use a minimum of 10 gal water per acre for 

ground application.

Fruiting Vegetables (Group 8-10)

Soil at Planting (infurrow spray, 

transplant water 

treatment, hill drench, 

surface band, soil 

shank injection)

18.66% SC

[352-IAN]

VerimarkTM

0.176

lb ai/A

0.00202

lb ai/gal

1

0.176

lb ai/A N/A Only to be applied to the soil by ground or drip 

chemigation application equipment. Must be 

applied uniformly in the root zone. Do not

make aerial or airblast applications. Do not treat 

plants being grown for transplanting in 

nurseries. Use this product only in commercial 

and farm plantings. May be used on crops 

Drip chemigation grown for seed production.

18.66% SC

[352-IAN]

VerimarkTM

0.130

lb ai/A

0.00149

lb ai/gal

2

(1 if atplant 

app is 

made)

0.260

lb ai/A 10
Page 14 of 47

Table 4.1. Summary of Proposed Directions for Use of Cyantraniliprole (DuPont and Syngenta Labels)

Application 

Timing, Type, and 

Equipment

Formulation

[EPA Reg. No.]

Trade Namea

Maximum 

Application 

Rate

Max. No. 

of

Apps per

Season

Max. 

Seasonal 

Application 

Rate

RTI Use Directions and Limitations

Foliar

(ground, aerial)

Foliar

(greenhouse)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S 0.4

lb ai/A 1

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates: non-ionics; organosilicones/

organosilicates). Use a minimum of 10 gallons 

per acre for all vegetable crops.

Soil

(in-furrow spray at 

seeding or 

transplanting; post 

seeding, post 

transplant, hill 

drench; drip 

(trickle) 

chemigation; 

shanked into root 

zone)

20.0% WG

[100-RUER]

A16901B CP

0.175

lb ai/A

0.0175

lb ai/gal

1

0.4

lb ai/A NA

Use this product only in commercial and farm 

plantings. Do not use in greenhouses. Do not 

treat plants grown for transplanting. Apply 

within 21 days of planting or transplanting. 

Make only one soil application per growing 

season.

Foliar

(ground, aerial, 

chemigation)

20.0% WG

[100-RUER]

A16901B CP

0.0875

lb ai/A

0.00875

lb ai/gal

N/S 0.4

lb ai/A 7

Use this product only in commercial and farm 

plantings. Do not use in greenhouses. Do not 

treat plants grown for transplanting. Apply 

within 21 days of planting or transplanting. 

Use a minimum of 10 gal water per acre for 

ground application.

Leafy Vegetables (non-Brassica) (Group 4)

Soil at Planting

(in-furrow spray, 

transplant water 

treatment, hill drench, 

surface band, soil 

shank injection)

18.66% SC

[352-IAN]

VerimarkTM

0.176

lb ai/A

0.00202

lb ai/gal

1

0.176

lb ai/A N/A

Only to be applied to the soil by ground or drip 

chemigation application equipment. Must be 

applied uniformly in the root zone. Do not

make aerial or airblast applications. Do not treat 

plants being grown for transplanting in 

nurseries.

Use this product only in commercial and farm 

plantings. May be used on crops grown for seed 

production.

Foliar

(ground, aerial)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S 0.4

lb ai/A 1

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates: non-ionics; organosilicones/

organosilicates). Use a minimum of 10 gallons 

per acre for all vegetable crops.

Soil

(in-furrow spray at 

seeding or 

transplanting; post 

seeding, post 

transplant, hill 

drench; drip 

(trickle) 

chemigation; 

shanked into root 

zone)

20.0% WG

[100-RUER]

A16901B CP

0.175

lb ai/A

0.0175

lb ai/gal

1

0.4

lb ai/A NA

Use this product only in commercial and farm 

plantings. Do not use in greenhouses. Do not 

treat plants grown for transplanting. Apply 

within 21 days of planting or transplanting. 

Make only one soil application per growing 

season.
Page 15 of 47

Table 4.1. Summary of Proposed Directions for Use of Cyantraniliprole (DuPont and Syngenta Labels)

Application 

Timing, Type, and 

Equipment

Formulation

[EPA Reg. No.]

Trade Namea

Maximum 

Application 

Rate

Max. No. 

of

Apps per

Season

Max. 

Seasonal 

Application 

Rate

RTI Use Directions and Limitations

Foliar

(ground, aerial, 

chemigation)

20.0% WG

[100-RUER]

A16901B CP

0.0875

lb ai/A

0.00875

lb ai/gal

N/S 0.4

lb ai/A 7

Use this product only in commercial and farm 

plantings. Do not use in greenhouses. Do not 

treat plants grown for transplanting. Apply 

within 21 days of planting or transplanting. 

Use a minimum of 10 gal water per acre for 

ground application.

Mustard Seed

Seed treatmentb

50% FS

[352-ILI]

Dermacor®

Z-103

1.0

lb ai/cwt 1

0.4

lb ai/A 7

Apply as a water-based slurry prior to planting. 

May be applied with other registered seed 

treatment fungicides and insecticides. Use EPAapproved dye or colorant to ensure that seed 

pieces are dyed an unnatural color.

Oilseed Crops (Group 20) (see also rapeseed)

Foliar

(ground, aerial)

10.26% OD

[352-ILT]

BeneviaTM

0.133

lb ai/A

0.0133

lb ai/gal

N/S 0.4

lb ai/A 7

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates: non-ionics; organosilicones/

organosilicates). Use a minimum of 10 gallons 

per acre for oilseed crops.

Pome Fruits (Group 11-10)

Foliar

(ground, aerial)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S 0.4

lb ai/A 7

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates: non-ionics; organosilicones/

organosilicates). Use a minimum of 30 gallons 

per acre for all fruit and nut crops.

Potato

Seed piece 

treatmentb

18.66% SC

[352-IAN]

VerimarkTM

0.176

lb ai/A

0.010

lb ai/ cwt

1

0.176

lb ai/A N/A

Apply as a water-based slurry prior to planting. 

May be applied with other registered seed 

treatment fungicides and insecticides. Use 

EPA-approved dye or colorant to ensure that 

seed pieces are dyed an unnatural color. Treat 

seed pieces as close to planting as possible. If 

planting is delayed, do not cover seed pieces as 

rotting can be accelerated. Best results are 

obtained if treated potatoes are allowed to dry 

during transit and planted the same day of 

treatment.

Seed piece 

treatmentb

48.8% FS

[100-RUEN]

A17960A ST

0.000135 lb 

ai/lb seed 1

0.000135 

lb ai/lb 

seed

N/A

Seed piece 

treatmentb

48.8% FS

[100-RURI]

A17960B ST

0.000135 lb 

ai/lb seed 1

0.000135 

lb ai/lb 

seed

N/A

Rapeseed (Canola)

Seed treatmentb

50% FS

[352-ILI]

Dermacor®

Z-103

1.0

lb ai/cwt 1

0.4

lb ai/A N/A

Apply as a water-based slurry prior to planting. 

May be applied with other registered seed 

treatment fungicides and insecticides. Use EPAapproved dye or colorant to ensure that seed 

pieces are dyed an unnatural color.
Page 16 of 47

Table 4.1. Summary of Proposed Directions for Use of Cyantraniliprole (DuPont and Syngenta Labels)

Application 

Timing, Type, and 

Equipment

Formulation

[EPA Reg. No.]

Trade Namea

Maximum 

Application 

Rate

Max. No. 

of

Apps per

Season

Max. 

Seasonal 

Application 

Rate

RTI Use Directions and Limitations

Stone Fruits (Group 12)

Foliar

(ground, aerial)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S 0.4

lb ai/A 7

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates: non-ionics; organosilicones/

organosilicates). Use a minimum of 30 gallons 

per acre for all fruit and nut crops.

Sunflower

Seed treatmentb

48.8% FS

[100-RUEN]

A17960A ST

0.2

mg ai/seed

0.00397

lb ai/lb seed

1

0.2 mg

ai/seed 

0.00397 

lb ai/lb 

seed

N/A Apply as a water-based slurry prior to planting. 

May be applied with other registered seed 

treatment fungicides and insecticides. Use EPAapproved dye or colorant to ensure that seed 

Seed treatment pieces are dyed an unnatural color. b

48.8% FS

[100-RURI]

A17960B ST

1 N/A

Tree Nuts (Group 14) and Pistachio

Foliar

(ground, aerial)

10.20% SE

[352-ILO]

ExirelTM

0.133

lb ai/A

0.00443

lb ai/gal

N/S 0.4

lb ai/A 7

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates: non-ionics; organosilicones/

organosilicates). Use a minimum of 30 gallons 

per acre for all fruit and nut crops.

Foliar

(ground, aerial)

10.26% OD

[352-ILT]

BeneviaTM

0.133

lb ai/A

0.000443

lb ai/gal

N/S 0.4

lb ai/A 7

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates: non-ionics; organosilicones/

organosilicates). Use a minimum of 30 gallons 

per acre for tree nuts.

Tuberous and Corm Vegetables (Subgroup 1C)

Soil at Planting

(in-furrow spray, 

transplant water 

treatment, hill drench, 

surface band, soil 

shank injection)

18.66% SC

[352-IAN]

VerimarkTM

0.176

lb ai/A

0.010

lb ai/ cwt

1

0.176

lb ai/A N/A

Only to be applied to the soil by ground or drip 

chemigation application equipment. Must be 

applied uniformly in the root zone. Do not

make aerial or airblast applications. Do not treat 

plants being grown for transplanting in 

nurseries. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production.
Page 17 of 47

Table 4.1. Summary of Proposed Directions for Use of Cyantraniliprole (DuPont and Syngenta Labels)

Application 

Timing, Type, and 

Equipment

Formulation

[EPA Reg. No.]

Trade Namea

Maximum 

Application 

Rate

Max. No. 

of

Apps per

Season

Max. 

Seasonal 

Application 

Rate

RTI Use Directions and Limitations

Foliar

(ground, aerial)

Chemigation 

(overhead only)

10.26% OD

[352-ILT]

BeneviaTM

0.133

lb ai/A

0.0133

lb ai/gal

N/S 0.4

lb ai/A 5

Do not treat plants grown for transplanting. Do 

not apply to the soil or through drip irrigation 

systems. Use this product only in commercial 

and farm plantings. May be used on crops 

grown for seed production. Adjuvants may be 

used (methylated seed oils; petroleum oil 

concentrates: non-ionics; organosilicones/

organosilicates). Use a minimum of 10 gallons 

per acre for tuberous and corm vegetables.

Soil

(in-furrow spray 

during planting; 

apply impregnated 

on dry granular

fertilizer before or 

during planting; at 

plant emergence 

by direct spray to 

the soil near base 

of plant and 

incorporate with 

irrigation; at plant 

emergence with 

overhead 

chemigation after 

hilling)

20.0% WG

[100-RUER]

A16901B CP

0.125

lb ai/A

0.0125

lb ai/gal

1

0.4

lb ai/A NA

Use this product only in commercial and farm 

plantings. Do not use in greenhouses. Do not 

treat plants grown for transplanting. Apply 

within 21 days of planting or transplanting. 

Make only one soil application per growing 

season.

Residential, Commercial, Agricultural Structures

(Single and multi-family residential buildings, schools, institutional, commercial, agricultural and industrial facilities (including warehouses, apartments, 

supermarkets, restaurants, motels, hotels, hospitals, daycares, and food handling/storage/processing establishments, animal production facilities, feedlots, 

broiler houses, livestock barns, pet kennels) and transportation equipment such as aircraft, trains, ships, boats and buses).

Broadcast or 

bait station

0.5% G

[352-IAE]

HGW86

Fly Control Bait

0.0871

lb ai/A

0.00000200

lb ai/sq ft

As 

needed

Not 

specified 7

INTENDED FOR USE BY COMMERCIAL 

APPLICATORS ONLY.

Broadcast or scatter HGW86 fly control bait 

using suitable granular spreader equipment or

directly from the container evenly to the target 

areas. Use in indoor areas at all the above 

described use sites only if HGW86 fly control 

bait is placed in bait stations. Use commercially 

available bait stations that are designed to hold 

granular baits. When bait stations are being 

used, place them where the stations are 

inaccessible to children or pets.

Outdoor: broadcast

Indoor: crack and 

crevice, including 

indoor areas with 

exposed food/feed 

present

18.66% SC

[352-IAI]

HGW86 SC 

Insect Control

0.0355

lb ai/1000 sq ft

0.00887 lb 

ai/gallon

As 

needed

Not 

specified 7

INTENDED FOR USE BY COMMERCIAL 

APPLICATORS ONLY.

Avoid spraying food and feed handling 

equipment. Do not apply to areas that are 

routinely washed such as cracks and crevices in 

tops of tables, food/feed preparation and 

prepared food holding surfaces. Do not apply a 

broadcast or general surface application to

interior surfaces of residential or commercial 

structures. Do not apply this product to pets, 

edible crops, or sources of electricity. Do not 

make applications to structures while occupied 

by livestock, poultry or companion animals. Do 

not apply to milk rooms or feed rooms. Do not 

make applications to any animal feedstuffs, 

water, or watering equipment. Do not 

contaminate any animal food, feed, or water in 

and around livestock, poultry, or companion 

animal housing when making applications.
Page 18 of 47

Table 4.1. Summary of Proposed Directions for Use of Cyantraniliprole (DuPont and Syngenta Labels)

Application 

Timing, Type, and 

Equipment

Formulation

[EPA Reg. No.]

Trade Namea

Maximum 

Application 

Rate

Max. No. 

of

Apps per

Season

Max. 

Seasonal 

Application 

Rate

RTI Use Directions and Limitations

Ornamentals

(Ornamental plants/shrubs/trees and vegetable transplants in and around greenhouses, nurseries, interior plantscapes, lath and shadehouses (grassy, weedy, 

mulched, bare soil areas in and around), trees (including non-fruit bearing and nut trees), shrubs, evergreens, bedding plants, flowering plants, flowers, 

foliage plants, ground covers, vines (non-bearing), interior plantscape plants, vegetable transplants (including fruiting, leafy, and tuberous/corm)).

Foliar spray, soil 

broadcast spray, soil 

drench, soil injection, 

or chemigation

18.66% SC

[352-IAG]

HGW86 GH&N 

Insect Control

0.261

lb ai/A

0.00326

lb ai/gal

2

0.418

lb ai/A 7

Do not apply this product with aerial application 

equipment. Do not apply to greenhouse or field 

grown vegetables, only apply to vegetable 

transplants grown in enclosed structures.

Foliar

18.66% SC

[352-IAL]

HGW86 T&O 

Insect Control

0.313

lb ai/A

0.00418

lb ai/gal

2

0.418

lb ai/A 7

Do not apply this product through any type of 

irrigation system. Do not apply this product 

with aerial application equipment. Do not use 

on plants being grown for sale or other 

commercial use; or for commercial seed 

production. Do not apply this product in 

commercial nurseries and greenhouses.

Foliar, soil, 

chemigation, or 

handheld equipment

20% WG

[100-RUEE]

Mainspring 

Insecticide

0.131

lb ai/A

0.00131

lb ai/gal

2

0.263

lb ai/A 14 Do not apply with aerial equipment.

Soil (individual fire 

ant mound treatment)

20% WG

[100-RUEE]

Mainspring 

Insecticide

0.00475

lb ai/gal NA NA NA

For small mounds (<6 inch in diameter) apply 1 

gal of water per mound and for larger mounds 

apply 2-3 gal of dilute solution per mound for 

optimum control. Direct the application to the 

center of the mound, including a 6-inch diameter 

circle.

Foliar

20% WG

[100-RUEG]

A16901B 

Residential

0.000781

lb ai/gal 2

0.00156

lb ai/gal 7

Mix 1 teaspoon in 1 gallon of water.

Apply as a thorough cover spray.

1 gallon treats plants in a 400 square feet area.

Turfgrass

(including golf courses, institutional, commercial and residential lawns, landscape, recreational, sod farms, sports fields, parks, municipal grounds and 

cemeteries).

Foliar

18.66% SC

[352-IAL]

HGW86 T&O 

Insect Control

0.313

lb ai/A

0.00418

lb ai/gal

2

0.418

lb ai/A 7

Do not apply this product through any type of 

irrigation system. Do not apply this product 

with aerial application equipment. Do not use 

on plants being grown for sale or other 

commercial use; or for commercial seed 

production. Do not apply this product in 

commercial nurseries and greenhouses.

Foliar

20% WG

[100-RUEU]

A16901B Turf 

Insecticide

0.133

lb ai/A

0.00203

lb ai/gal

2

0.265

lb ai/A 30 Do not apply this product through any type of irrigation system.

a Formulation codes: G = granular, SC = suspension concentrate, SE = suspoemulsion, WG = water dispersible granules, OD = 

oil dispersion, FS = flowable suspension.

b cwt = hundredweight (100 lb seed).

Seed treatment rate calculations are based on the following assumptions:

Mustard seed: 90,000 to 115,000 seeds per lb (assumed to be equivalent to rapeseed/canola).

Potato seed pieces: 5 to 11 seed pieces per lb.

Rapeseed (canola): 90,000 to 115,000 seeds per lb.

Sunflowers: 2,000 to 9,000 seeds per lb.
Page 19 of 47

5.0 Residential Exposure and Risk Estimates

At this time, there are newly proposed residential uses of cyantraniliprole that may lead to 

handler and post-application exposures for both adults and children. Adults may be exposed 

during handling and post-application activities (via dermal and inhalation routes; children may 

be exposed during post-application activities (via dermal and incidental oral routes). However, 

since dermal hazard has not been identified for cyantraniliprole, the only exposures of concern 

are handler inhalation for adults, and post-application incidental oral for children. These uses

have been assessed with current policies which include updates to HED’s 2012 Residential 

SOPs2along with policy changes for body weight assumptions.

The end use products that may lead to residential exposures (handler and/or post-application 

exposure) include the following EPs:

1. EPA Reg. No. 352-IAE (fly bait for use in and around residential structures);

2. EPA Reg. No. 352-IAG (foliar and systemic insect control on ornamental 

plants/shrubs/trees, and interior plantscapes);

3. EPA Reg. No. 352-IAI (for use in single and multi-family residential buildings, schools, 

apartments, and daycares); and

4. EPA Reg. No. 352-IAL (foliar and systemic insect control in landscape and recreational 

turfgrass, including golf courses and interior plantscapes);

5. EPA Reg. No. 100-RUEG (outdoor applications to residential landscape plants); and

6. EPA Reg. No. 100-RUEU (foliar and systemic insect control in turfgrass including golf 

courses, residential lawns, and recreational turfgrass).

5.1 Residential Handler Exposure/Risk Estimates

HED uses the term “handlers” to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct tasks related to applications and that 

exposures can vary depending on the specifics of each task. Residential handlers are addressed 

somewhat differently by HED as homeowners are assumed to complete all elements of an 

application without use of any protective equipment.

Of all proposed residential uses, only one WG product is intended for homeowner use: A16901B 

Residential (EPA Reg. No. 100-RUEG: outdoor applications to residential landscape plants). 

However, since the other labels include residential use sites, use by homeowners is possible, and 

prohibition of use by homeowners is not enforceable. Thus, residential handler exposure and 

risk estimates have been calculated for all possible residential exposure scenarios. Including all 

possible residential exposure scenarios provides a conservative and health protective assessment 

for the potential for homeowners to use the professionally labeled products on residential use 

sites. The formulations for the other labels include G and SC.

Since there are no toxicity findings for the short-term dermal route of exposure up to the limit 

dose, the residential handler assessment only includes the inhalation route of exposure.

 

2 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 20 of 47

Residential Handler Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the residential 

handler risk assessments. Each assumption and factor is detailed below.

Application Rate: Refer to the proposed use pattern table in Section 4.0.

Unit Exposures and Area Treated or Amount Handled: Unit exposure values and estimates for 

area treated or amount handled were taken from HED’s 2012 Residential SOPs3(Lawns/Turf; 

Gardens and Trees; Indoor Environments).

Exposure Duration: Residential handler exposure is expected to be short-term in duration. 

Intermediate-term exposures are not likely because of the intermittent nature of applications by 

homeowners.

Residential Handler Non-Cancer Exposure and Risk Estimate Equations

The algorithms used to estimate exposure and dose for residential handlers can be found in the 

2012 Residential SOPs4(Lawns/Turf; Gardens and Trees; Indoor Environments).

Combining Exposures/Risk Estimates:

The dermal route of exposure does not need to be combined with another route of exposure or 

included in the aggregate risk assessment because there is no identified dermal hazard.

Summary of Residential Handler Non-Cancer Exposure and Risk Estimates

Handler risk estimates were assessed for all possible residential handler scenarios in which 

homeowners may be exposed to cyantraniliprole. Risk estimates of all possible scenarios are not 

of concern. Short-term inhalation MOEs range from 22,000 to 220,000,000 as summarized in 

Table 5.1. Furthermore, these calculated risk estimates are highly conservative because the 

inhalation exposure POD is based on an exposure duration of 24 hours per day.

Table 5.1. Residential Handler Non-Cancer Exposure and Risk Estimates for Cyantraniliprole

Application 

Equipment Crop or Target

Inhalation 

Unit 

Exposure

Maximum 

Application 

Ratea

Amount 

Handled 

Dailyb

Inhalation

Dosec

MOEd

mg/lb ai mg/kg/day

Mixer/Loader/Applicator for Granular Formulations

Push-Type 

Rotary Spreader

Outdoor areas used for storage of 

waste around commercial 

establishments, commercial 

operations, and agricultural animal 

production facilities

0.0026 0.0871

lb ai/A

0.5

acres

0.00000142 5,100,000

Belly Grinder 0.039

0.00000200

lb ai/sq ft

1200

sq ft 0.00000117 6,200,000

Spoon 0.087

100

sq ft

0.000000218 33,000,000

Cup 0.013 0.0000000325 220,000,000

Hand Dispersal 0.38 0.000000950 7,600,000

Shaker Can 0.013 0.0000000325 220,000,000

 

3 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html

4 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 21 of 47

Table 5.1. Residential Handler Non-Cancer Exposure and Risk Estimates for Cyantraniliprole

Application 

Equipment Crop or Target

Inhalation 

Unit 

Exposure

Maximum 

Application 

Ratea

Amount 

Handled 

Dailyb

Inhalation

Dosec

MOEd

mg/lb ai mg/kg/day

Bait 

Station/Trap

Indoor areas of residential, 

institutional, public, agricultural 

buildings/structures, or food/feed 

handling establishments (including 

restaurants, warehouses, 

supermarkets, hospitals, nursing 

homes, motels, hotels, schools, 

daycares, laboratories, computer 

facilities, aircraft, buses, boats/ships, 

trains, pet shops and zoos)

Exposure is considered negligible.

Mixer/Loader/Applicator for Liquid Formulations

ManuallyPressurized 

Handwand

Indoor Spot and Crack/Crevice 1.1 0.00887

lb ai/gal

0.5

gal 0.0000610 120,000

Outdoor Broadcast: Gardens/Trees 0.018

0.00000719

lb ai/sq ft

1200

sq ft 0.00000194 3,700,000

0.00418

lb ai/gal

5

gal 0.00000470 1,500,000

Outdoor Broadcast: Lawns/Turf

Hose-End 

Sprayer

Outdoor Broadcast: Gardens/Trees 0.0014

0.00000719

lb ai/sq ft

1200

sq ft 0.000000151 48,000,000

0.00418

lb ai/gal

11

gal 0.000000804 9,000,000

Outdoor Broadcast: Lawns/Turf 0.022 0.313

lb ai/A

0.5

acres

0.0000431 170,000

Backpack Outdoor Broadcast: Gardens/Trees 0.14

0.00000719

lb ai/sq ft

1200

sq ft 0.0000151 480,000

0.00418

lb ai/gal

5

gal 0.0000365 200,000

Outdoor Broadcast: Lawns/Turf

Sprinkler Can

Outdoor Broadcast: Gardens/Trees

0.0014 0.00000719

lb ai/sq ft

1200

sq ft 0.000000151 48,000,000

0.0014 0.00418

lb ai/gal

5

gal 0.000000365 20,000,000

Outdoor Broadcast: Lawns/Turf 0.022 0.00000719

lb ai/sq ft

1000

sq ft 0.00000198 3,600,000

Mixer/Loader/Applicator for Dry Flowable Formulations

ManuallyPressurized 

Handwand

Outdoor Broadcast: Gardens/Trees 1.1

0.00000301

lb ai/sq ft

1200

sq ft 0.0000497 140,000

0.00203

lb ai/gal

5

gal 0.000139 52,000 Outdoor Broadcast: Lawns/Turf

Hose-End 

Sprayer

Outdoor Broadcast: Gardens/Trees 0.0014

0.00000301

lb ai/sq ft

1200

sq ft 0.0000000633 110,000,000

0.00475

lb ai/gal

11

gal 0.000000914 7,900,000

Outdoor Broadcast: Lawns/Turf 0.022 0.133

lb ai/A

0.5

acres

0.0000182 400,000
Page 22 of 47

Table 5.1. Residential Handler Non-Cancer Exposure and Risk Estimates for Cyantraniliprole

Application 

Equipment Crop or Target

Inhalation 

Unit 

Exposure

Maximum 

Application 

Ratea

Amount 

Handled 

Dailyb

Inhalation

Dosec

MOEd

mg/lb ai mg/kg/day

Backpack

Outdoor Broadcast: Gardens/Trees

1.1

0.00000301

lb ai/sq ft

1200

sq ft 0.0000497 140,000

0.00475

lb ai/gal

5

gal 0.000327 22,000

Outdoor Broadcast: Lawns/Turf 0.00203

lb ai/gal

5

gal 0.000139 52,000

Sprinkler Can

Outdoor Broadcast: Gardens/Trees 0.0014

0.00000301

lb ai/sq ft

1200

sq ft 0.0000000633 110,000,000

0.00475

lb ai/gal

5

gal 0.000000416 17,000,000

Outdoor Broadcast: Lawns/Turf 0.022 0.00000304

lb ai/sq ft

1000

sq ft 0.000000836 8,600,000

a Based on maximum application rates on proposed labels:

EPA Reg. No. 352-IAE for granular application to indoor and outdoor areas,

EPA Reg. No. 352-IAI for liquid applications to indoor crack and crevices, 

EPA Reg. No. 352-IAL for liquid applications to ornamentals and turf,

EPA Reg. No. 100-RUEE for dry flowable applications to ornamentals, and

EPA Reg. No. 100-RUEU for dry flowable applications to turf.

b Based on HED’s 2012 Residential SOPs: Lawns/Turf; Gardens and Trees; Indoor Environments

(http://www.epa.gov/pesticides/science/residential-exposure-sop.html).

c Inhalation Dose = Inhalation Unit Exposure (mg/lb ai) × Application Rate (lb ai/acre or lb ai/gal) × Amount Handled (A/day or 

gallons/day) ÷ BW (80 kg adult).

d Inhalation MOE = Inhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). Short-Term Inhalation NOAEL = 7.2

mg/kg/day. Level of concern = 30.

5.2 Residential Post-Application Exposure/Risk Estimates

There is the potential for post-application exposure for individuals as a result of being in an 

environment that has been previously treated with cyantraniliprole. Since dermal hazard has not 

been identified for cyantraniliprole, a quantitative assessment for dermal exposure is not 

necessary and the only exposures of concern are for children 1 to <2 years old who may 

experience incidental oral post-application exposure to cyantraniliprole from treated turf and 

indoor cracks/crevices. Furthermore, a risk assessment for incidental oral ingestion of granules 

has not been conducted based on a lack of hazard via the acute dietary route of exposure; and an 

indoor inhalation risk assessment has not been conducted because the acute inhalation toxicity is 

low (Toxicity Category IV), and exposure is expected to be negligible based on the low vapor 

pressure of cyantraniliprole (3.85×10-17 mm Hg at 20oC) and the low proposed application rate 

(0.391 lb ai/A).

The end use products that may lead to residential post-application exposures include the 

following EPs:

1. EPA Reg. No. 352-IAE (G fly bait for use in and around residential structures);

2. EPA Reg. No. 352-IAI (SC crack and crevice use in single and multi-family residential 

buildings, schools, apartments, and daycares);

3. EPA Reg. No. 352-IAL (foliar and systemic insect control in landscape and recreational 

turfgrass, including golf courses and interior plantscapes); and
Page 23 of 47

4. EPA Reg. No. 100-RUEU (foliar and systemic insect control in turfgrass including golf 

courses, residential lawns, and recreational turfgrass).

The lifestage (children 1 to <2 years old) selected for each post-application scenario is based on 

an analysis provided as an Appendix in the 2012 Residential SOPs5. This lifestage is not the 

only lifestage that could be potentially exposed for these post-application scenarios; however, the 

assessment of these lifestages is health protective for the exposures and risk estimates for any 

other potentially exposed lifestages.

Residential Post-Application Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the residential 

post-application risk assessment. Each assumption and factor is detailed in the 2012 Residential 

SOPs5(Lawns/Turf; Indoor Environments) and Appendix B. Based on the SOPs, the deposited 

residue value for liquid application to indoor cracks/crevices was calculated to be 1.74 μg/cm2.

In addition to the SOPs, the registrant has submitted chemical-specific turf transferrable residue

(TTR) data (DP407965, N. Tsaur, 01/22/2013, Cyantraniliprole. Determination of Transferable 

Residues of Cyantraniliprole from Turf Treated with Water-Dispersible Granule (WG) and 

Granule (GR) Formulations of Cyantraniliprole). The high-end TTR value chosen to be 

protective of all exposure scenarios (regardless of formulation applied), is the predicted Day 0 

residue from the California site of 0.0282 μg/cm2. This value is based on a target application rate 

of 0.20 lb ai/A and must be adjusted for the proposed application rates in quantitative postapplication risk estimate calculations. Table 5.2.1 provides a regression summary for the TTR 

associated TTR study.

Table 5.2.1. Regression Summary for Turf Treated with Two Applications of Cyantraniliprolea

Statistic

SYN545377 WG (40) Formulation SYN545377 GR (.23) 

Formulation

Pennsylvania Georgia California Georgia

Actual Average 

Measured Residue on 

Day 0

(μg/cm2)

0.031

(first application)

0.021

(second 

application)

0.015

(first application)

0.015

(second 

application)

0.027

(first application)

0.0199

(second 

application)

0.00063

(first application)

0.000292

(second application)

Predicted Day 0 

Residue

(μg/cm2)

0.0158 0.0159 0.0282b0.000396

Slope -0.289 -0.362 -0.648 -0.0992

Half-life

(days) 2.40 1.91 1.07 6.99

R

2

0.952 0.978 0.948 0.237

Registrant’s predicted 

half-life (days) 2.5 2.0 1.4 7.0

Registrant’s R20.892 0.980 0.872 0.320

 

5 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 24 of 47

a Regression data is based on TTRs collected after the second (last) application. All applications were made at a 

target rate of 0.2 lb ai/A.

b The TTR value recommended for turf post-application risk assessment, regardless of formulation applied.

Residential Post-Application Non-Cancer Exposure and Risk Equations

The algorithms used to estimate residential post-application exposure and dose can be found in 

the 2012 Residential SOPs5(Lawns/Turf; Indoor Environments) and Appendix B.

Combining Exposure and Risk Estimates

The dermal route of exposure does not need to be combined with the assessed incidental oral 

route of exposure or included in the aggregate risk assessment because there is no identified 

dermal hazard.

Summary of Residential Post-Application Non-Cancer Exposure and Risk Estimates

Table 5.2.2 presents the post-application incidental oral MOE values calculated from the 

following application scenarios:

1. liquid application of cyantraniliprole to turf,

2. granular application to cyantraniliprole to turf, and

3. liquid application of cyantraniliprole to indoor cracks/crevices.

Post-application risk estimates for all scenarios are not of concern to HED (MOEs range from 

290 to 1,000,000). The incidental oral scenarios (i.e., hand-to-mouth and object-to-mouth) 

should be considered inter-related and it is likely that they occur interspersed amongst each other 

across time. However, combining these scenarios would be overly-conservative because of the 

conservative nature of each individual assessment. Therefore, the hand-to-mouth postapplication exposure scenario for children 1 < 2 years old should be considered a protective 

estimate of children’s exposure to pesticides used indoors. Furthermore, incidental oral risk 

estimates are highly conservative because the short- and intermediate-term incidental oral POD 

is based on a 90-day exposure duration.

Table 5.2.2. Residential Post-Application Non-Cancer Exposure and Risk Estimates for Cyantraniliprole

Lifestage

Post-Application Exposure Scenario Application 

Ratea

Doseb

MOEsc

Use Site Route of Exposure mg/kg/day

Children

1 to <2 years old

Liquid Application

to Turf

ST Hand to Mouth

0.313

lb ai/A

0.00604 500

ST Object to Mouth 0.000184 16,000

ST/IT Incidental Soil Ingestion 0.0000106 280,000

Granular Application

to Turf

ST Hand to Mouth

0.0871

lb ai/A

0.000834 3,600

ST Object to Mouth 0.0000511 59,000

ST/IT Incidental Soil Ingestion 0.00000295 1,000,000

Incidental Granular Ingestion Acute dietary hazard not identified.

Liquid Application to 

Cracks/Crevices

(Carpet)

ST/IT Hand to Mouth

0.0000355

lb ai/sq ft

0.0103 290

ST/IT Object to Mouth 0.00137 2,200

Liquid Application to 

Cracks/Crevices

(Hard Surfaces)

ST/IT Hand to Mouth 0.00342 880

ST/IT Object to Mouth 0.000910 3,300

a Based on registered or proposed label (Reg. Nos.352-IAE, 352-IAI, 352-IAL).

EPA Reg. No. 352-IAE for granular application to indoor and outdoor areas,
Page 25 of 47

EPA Reg. No. 352-IAI for liquid applications to indoor crack and crevices, and

EPA Reg. No. 352-IAL for liquid applications to turf.

b Dose (mg/kg/day) equations:

Hand-to-Mouth Dose = hand residue loading (μg/cm2) × fraction of hand mouthed (0.127) × surface area of 1 hand (150 cm2) 

× exposure time (1.5 hrs/day) × # of replenishment intervals/hr (4 int/hr) × (1-((1-saliva extraction factor (0.5))^(Number of 

hand-to-mouth events per hour (13.9 events/hr) ÷ # of replenishment intervals/hr)) ÷ body weight (11 kg).

Object-to-Mouth Dose = object residue loading (μg/cm2) × unit conversion factor (0.001 mg/μg) × object surface area mouthed 

/ event (10 cm2/event) × exposure time (1.5 hrs/day) × # replenishment intervals/hr (4 int/hr) × (1-((1- saliva extraction factor 

(0.50))^(# Object-to-Mouth Events/hr (8.8 events/hr) ÷ # replenishment intervals/hr)) ÷ body weight (11 kg).

Soil Ingestion = soil residue (μg/g) × ingestion rate (50 mg/day) × conversion factor (0.000001 g/μg) ÷ body weight (11 kg).

TTR for liquid application rate of 0.313 lb ai/A = 0.0282 μg/cm2× (0.313 lb ai/A ÷ 0.20 lb ai/A) = 0.0441 μg/cm2.

TTR for granular application rate of 0.0871 lb ai/A = 0.0282 μg/cm2× (0.0871 lb ai/A ÷ 0.20 lb ai/A) = 0.0123 μg/cm2.

Deposited residue for liquid application to cracks/crevices = 1.74 μg/cm2.

c MOE = NOAEL ÷ Daily Dose (mg/kg/day). ST/IT Incidental Oral NOAEL = 3.0 mg/kg/day. Level of concern = 100.

5.3 Residential Risk Estimates for Use in Aggregate Assessment

For the purpose of the cyantraniliprole aggregate human health risk assessment, a summary of 

the most protective residential exposure estimates for all proposed residential uses are provided 

in Table 5.3. Based on the residential use profile, and the 2012 Revised Residential SOPs, only 

short-term inhalation residential handler exposures (for adults) and short-/intermediate-term 

incidental oral post-application exposures (for children) should be included in the aggregate risk 

assessment. It is noted that intermediate-term incidental oral post-application exposures are 

possible (i.e. from indoor applications and form soil ingestion due to the persistence of 

cyantraniliprole); however, the short-term incidental oral exposures are protective of the possible 

intermediate-term incidental oral exposures because the POD for both durations is the same.

Although it is possible for residential handlers to have combined exposures from concurrent turf 

and ornamental applications (based on the proposed label for EPA Reg. No. 352-IAL which 

would result in an MOE of 90,000)6, the suggested exposure contribution for aggregate risk 

estimate is based on the most protective risk estimate from dry flowable application to 

ornamentals only (based on the proposed label for EPA Reg. No. 100-RUEE which results in an 

MOE of 22,000). The most protective risk estimate for children’s post-application incidental 

oral exposures is based on indoor liquid crack/crevice application to carpets which results in an 

MOE of 290.

Table 5.3. Scenarios Recommended for Aggregate Risk Assessment of Cyantraniliprole

Scenario Daily DoseaMOEb

mg/kg/day

Adults 

Residential Handler Inhalation Exposure

(Applying Dry Flowables to Ornamentals with a Backpack Sprayer) 0.000327 22,000

Children (1 to <2 Years Old)

Post-Application Incidental Oral Exposure: Hand-to-Mouth

(After Liquid Application to Cracks/Crevices on Carpet) 0.0103 290

 

6

 EPA Reg. No. 352-IAL (SC) may lead to concurrent turf and ornamental exposures. A conservative healthprotective calculation of these two exposures results in a daily dose of 0.0000431 mg/kg/day (liquid application to 

lawns/turf) + 0.0000365 mg/kg/day (liquid application to gardens/trees) = 0.0000796 mg/kg/day; thus resulting in a 

combined MOE of 90,000 (NOAEL of 7.2 mg/kg/day ÷ 0.0000796 mg/kg/day).
Page 26 of 47

a Daily Dose = See Table 5.1 for adult handler scenarios and Table 5.2.2 for post-application incidental oral

scenarios. Adults based on EPA Reg. No. 100-RUEE (WG). Children based on EPA Reg. No. 352-IAI (SC).

b MOE = NOAEL/Daily Dose (mg/kg/day).

ST Inhalation NOAEL = 7.2 mg/kg/day. ST Inhalation LOC = 30.

ST/IT Incidental Oral = 3.0 mg/kg/day. ST Incidental Oral LOC = 100.

5.4 Spray Drift

Spray drift is always a potential source of exposure to residents nearby to spraying operations. 

This is particularly the case with aerial application, but, to a lesser extent, could also be a 

potential source of exposure from the ground application method employed for cyantraniliprole. 

The Agency has been working with the Spray Drift Task Force, EPA Regional Offices, and State 

Lead Agencies for pesticide regulation and other parties to develop the best spray drift 

management practices (see the Agency’s Spray Drift website for more information)

7

. The 

Agency has completed its evaluation of the new database submitted by the Spray Drift Task 

Force, a membership of U.S. pesticide registrants, and is developing a policy on how to 

appropriately apply the data and the AgDRIFT computer model to its risk assessments for 

pesticides applied by air, orchard airblast, and ground hydraulic methods. After the policy is in 

place, the Agency may impose further refinements in spray drift management practices to reduce 

off-target drift with specific products with significant risk estimates associated with drift.

Although a quantitative residential post-application inhalation exposure assessment was not 

performed as a result of pesticide drift from neighboring treated agricultural fields, an inhalation 

exposure assessment was performed for flaggers. This exposure scenario is representative of a 

worse case inhalation (drift) exposure and may be considered protective of most outdoor 

agricultural and commercial post-application inhalation exposure scenarios. 

It is noted that the 0.313 lb ai/acre application rate for turf was modeled to estimate postapplication residential exposure of children. As this rate is equal to or higher than many of 

agricultural application rates, this scenario is protective of any incidental ingestion exposure of 

farm children via spray drift from agricultural cyantraniliprole applications.

5.5 Residential Bystander Post-Application Inhalation Exposure

Based on the Agency's current practices, a quantitative post-application inhalation exposure 

assessment was not performed for cyantraniliprole at this time primarily because of the low acute 

inhalation toxicity (Toxicity Category IV), low vapor pressure (3.85×10-17 mm Hg at 20oC), and 

the low proposed use rate (0.391 lb ai/A). However, volatilization of pesticides may be a source 

of post-application inhalation exposure to individuals nearby pesticide applications. The Agency 

sought expert advice and input on issues related to volatilization of pesticides from its Federal 

Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, 

and received the SAP’s final report on March 2, 20108. The Agency is in the process of 

evaluating the SAP report and may, as appropriate, develop policies and procedures to identify 

the need for and, subsequently, the way to incorporate post-application inhalation exposure into 

the Agency's risk assessments. If new policies or procedures are developed, the Agency may 

 

7 Available: http://www.epa.gov/opp00001/factsheets/spraydrift.htm 

8 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html
Page 27 of 47

revisit the need for a quantitative post-application inhalation exposure assessment for 

cyantraniliprole.

6.0 Occupational Exposure and Risk Estimates

6.1 Agricultural Occupational Handler Exposure/Risk Estimates

HED uses the term handlers to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct job functions or tasks related to 

applications and exposures can vary depending on the specifics of each task. Job requirements 

(amount of chemical used in each application), the kinds of equipment used, the target being 

treated, and the level of protection used by a handler can cause exposure levels to differ in a 

manner specific to each application event. 

Based on the anticipated use patterns and current labeling, types of equipment and techniques 

that can potentially be used, occupational handler exposure is expected from the proposed

agricultural uses. The quantitative exposure/risk assessment developed for occupational handlers 

is based on several scenarios which include mixing/loading/applying various formulations of 

cyantraniliprole, including liquids, dry flowables, and granules. The use sites are summarized in 

Section 4.0. Methods of application include aerial, airblast, chemigation, groundboom, seed 

treatment, and handheld equipment. Refer to Table 6.1 for a detailed list of each scenario.

Occupational Handler Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the occupational 

handler risk assessments. Each assumption and factor is detailed below on an individual basis.

Application Rate: Refer to the proposed use pattern table in Section 4.0.

Unit Exposures: It is the policy of HED to use the best available data to assess handler exposure. 

Sources of generic handler data, used as surrogate data in the absence of chemical-specific data, 

include PHED 1.1, the AHETF database, the Outdoor Residential Exposure Task Force 

(ORETF) database, or other registrant-submitted occupational exposure studies. Some of these 

data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. 

The standard values recommended for use in predicting handler exposure that are used in this 

assessment, known as “unit exposures”, are outlined in the “Occupational Pesticide Handler Unit 

Exposure Surrogate Reference Table9”, which, along with additional information on HED policy 

on use of surrogate data, including descriptions of the various sources, can be found at the 

Agency website10.

Area Treated or Amount Handled: The area treated or amount handled is based on HED 

ExpoSAC Policy No. 9.1. Refer to Table 6.1 for these assumptions for each scenario.

Exposure Duration: HED classifies exposures from 1 to 30 days as short-term and exposures 30 

days to six months as intermediate-term. Exposure duration is determined by many things, 

 

9 Available: http://www.epa.gov/opp00001/science/handler-exposure-table.pdf

10 Available: http://www.epa.gov/pesticides/science/handler-exposure-data.html
Page 28 of 47

including the exposed population, the use site, the pest pressure triggering the use of the 

pesticide, and the cultural practices surrounding that use site. For most agricultural uses, it is 

reasonable to believe that occupational handlers will not apply the same chemical every day for 

more than a one-month time frame; however, there may be a large agribusiness and/or 

commercial applicators who may apply a product over a period of weeks (e.g. completing 

multiple applications for multiple clients within a region).

Mitigation/Personal Protective Equipment: Results are presented for “baseline,” defined as a 

single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no 

protective gloves, and no respirator.

Occupational Handler Non-Cancer Exposure and Risk Estimate Equations

The algorithms used to estimate non-cancer exposure and dose for occupational handlers can be 

found in Appendix A.

Combining Exposures/Risk Estimates

The dermal route of exposure does not need to be combined with the assessed inhalation route of 

exposure or included in the aggregate risk assessment because there is no identified dermal 

hazard.

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates

The results of the occupational handler exposure and risk assessment indicate that short- and 

intermediate-term inhalation risks do not exceed HED’s LOC (i.e. an MOE < 30 for short-term 

exposures and an MOE < 100 for intermediate-term exposures) at baseline mitigation (no PPE). 

Since the short- and intermediate-term PODs are the same, the inhalation MOEs are also the 

same, ranging from 1,200 to 3,900,000. Note that only engineering control (enclosed cockpit) 

data are available to assess risks to handlers operating aircrafts.

The Agency matches quantitative occupational exposure assessment with appropriate 

characterization of exposure potential. While HED presents quantitative risk estimates for 

human flaggers when appropriate, agricultural aviation has changed dramatically over the past 

two decades. According the 2012 National Agricultural Aviation Association (NAAA) survey of 

their membership, the use of GPS for swath guidance in agricultural aviation has grown steadily 

from the mid 1990’s. Over the same time period, the use of human flaggers for aerial pesticide 

applications has decreased steadily from ~15% in the late 1990’s to only 1% in the most recent 

(2012) NAAA survey. The Agency will continue to monitor all available information sources to 

best assess and characterize the exposure potential for human flaggers in agricultural aerial 

applications.

HED has no data to assess exposures to pilots using open cockpits. The only data available is for 

exposure to pilots in enclosed cockpits. Therefore, risks to pilots are assessed using the 

engineering control (enclosed cockpits) and baseline attire (long-sleeve shirt, long pants, shoes, 

and socks); per the Agency’s Worker Protection Standard stipulations for engineering controls, 

pilots are not required to wear protective gloves for the duration of the application. With this 

level of protection, there are no risk estimates of concern for applicators.
Page 29 of 47

Table 6.1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Cyantraniliprole.

Exposure Scenario Crop or Target

a

Baseline 

Inhalation 

Unit 

Exposureb

Maximum

Application 

Ratec

Area 

Treated or 

Amount 

Handled 

Dailyd

Baseline Inhalation

Dosee MOEf

μg/lb ai lb ai/A Acres mg/kg/day ST LOC = 30

IT LOC = 100

Mixer/Loader

Mixing/Loading Dry 

Flowables for Aerial 

Application

Sod Farms

8.96

0.133

350

0.00520 1,900

Typical Field Crops 0.175 0.00686 1,500

Mixing/Loading Dry 

Flowables for Airblast 

Application

Nursery Plants 0.131 20 0.000294 34,000

Mixing/Loading Dry 

Flowables for 

Chemigation 

Application Only

Typical Field Crops 0.175 350 0.00686 1,500

Greenhouse Plants

0.131 60 0.000883 11,000

Nursery Plants

Mixing/Loading Dry 

Flowables for 

Groundboom 

Application

Golf Courses

(tees and greens only) 0.133 5 0.0000743 140,000

Golf Courses

(fairways, tees, and greens) 0.133 40 0.000594 17,000

Field-Grown Ornamentals 0.131 40 0.000588 17,000

Nursery Plants 0.131 60 0.000883 11,000 Greenhouse Plants

Sod Farms 0.133 80 0.00119 8,500

Typical Field Crops 0.175 80 0.00156 6,500

Mixing/Loading 

Liquids for Aerial 

Application

Orchard Crops

0.219

0.133 350 0.000128 79,000

Sod Farms 0.313 350 0.000300 34,000

Typical Field Crops 0.133 350 0.000128 79,000

High-Acreage Field Crops 0.133 1200 0.000436 23,000

Mixing/Loading 

Liquids for Airblast 

Application

Nursery Plants 0.261 20 0.0000143 700,000

Orchard Crops 0.133 40 0.0000145 700,000

Mixing/Loading 

Liquids for 

Chemigation

Orchard Crops 0.391 350 0.000375 27,000

Sod Farms 0.313 350 0.000300 34,000

Typical Field Crops 0.133 350 0.000128 79,000

High-Acreage Field Crops 0.133 350 0.000128 79,000

Greenhouse Plants 0.261 60 0.0000429 230,000

Nursery Plants 0.391 60 0.0000643 160,000

Mixing/Loading 

Liquids for 

Groundboom 

Application

Golf Courses

(tees and greens only) 0.313 5 0.00000429 2,300,000

Golf Courses

(fairways, tees, and greens) 0.313 40 0.0000343 290,000

Field-Grown Ornamentals 0.261 40 0.0000286 350,000

Nursery Plants 0.391 60 0.0000643 160,000

Greenhouse Plants 0.261 60 0.0000429 230,000

Sod Farms 0.313 80 0.0000686 150,000

Typical Field Crops 0.133 80 0.0000291 350,000

High-Acreage Field Crops 0.133 200 0.0000728 140,000
Page 30 of 47

Table 6.1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Cyantraniliprole.

Exposure Scenario Crop or Target

a

Baseline 

Inhalation 

Unit 

Exposureb

Maximum

Application 

Ratec

Area 

Treated or 

Amount 

Handled 

Dailyd

Baseline Inhalation

Dosee MOEf

μg/lb ai lb ai/A Acres mg/kg/day ST LOC = 30

IT LOC = 100

Applicator

Applying Sprays for 

Aerial Application

Orchard Crops

0.068

0.133 350 0.0000395 260,000

Sod Farms 0.133 350 0.0000394 260,000

Typical Field Crops 0.175 350 0.0000521 190,000

High-Acreage Field Crops 0.133 1200 0.000135 75,000

Applying Sprays for 

Airblast Application

Nursery Plants 4.71 0.131 20 0.000155 65,000

Orchard Crops 0.133 40 0.000313 32,000

Applying Sprays for 

Groundboom 

Application

Golf Courses

(tees and greens only)

0.34

0.133 5 0.00000281 3,600,000

Golf Courses

(fairways, tees, and greens) 0.133 40 0.0000225 450,000

Field-Grown Ornamentals 0.131 40 0.0000224 450,000

Nursery Plants 0.131 60 0.0000335 300,000 Greenhouse Plants

Sod Farms 0.133 80 0.0000450 220,000

Typical Field Crops 0.175 80 0.0000595 170,000

High-Acreage Field Crops 0.133 200 0.000113 89,000

Applying Granules via 

Hand Dispersal

Poultry/Livestock 

Houses/Horse Barns/Feedlots 470 0.0871 1 0.000511 20,000

Flagger

Flagging for Aerial 

Applications

Orchard Crops

0.35

0.133 350 0.000204 49,000

Sod Farms 0.133 350 0.000203 50,000

Typical Field Crops 0.175 350 0.000268 38,000

High-Acreage Field Crops 0.133 350 0.000204 49,000

Mixer/Loader/Applicator

M/L/A Dry Flowables 

for Backpack Sprayers

Greenhouse Plants (Foliar)

140 0.00131

lb ai/gal

40

gallons

0.0000919 110,000

Nursery Plants (Foliar)

Nursery Plants (Ground/Soil) 2.58 0.00475

lb ai/gal 0.00000613 1,600,000

Landscaping 

(trees/shrubs/bushes)

140 0.00131

lb ai/gal 0.0000919 110,000 Landscaping

(plants/flowers)

Landscaping

(turf, lawns, athletic fields, 

parks, etc)

2.58 0.00203

lb ai/gal 0.00000261 3,900,000

M/L/A Dry Flowables 

for ManuallyPressurized Handwand 

Sprayers

Greenhouse Plants (Foliar)

30 0.00131

lb ai/gal 40

gallons

0.0000198 510,000

Nursery Plants (Foliar)

Landscaping 

(trees/shrubs/bushes)

Landscaping

(plants/flowers)

Interior Landscaping

Landscaping

(turf, lawns, athletic fields, 

parks, etc)

30 0.00203

lb ai/gal 0.0000304 330,000
Page 31 of 47

Table 6.1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Cyantraniliprole.

Exposure Scenario Crop or Target

a

Baseline 

Inhalation 

Unit 

Exposureb

Maximum

Application 

Ratec

Area 

Treated or 

Amount 

Handled 

Dailyd

Baseline Inhalation

Dosee MOEf

μg/lb ai lb ai/A Acres mg/kg/day ST LOC = 30

IT LOC = 100

M/L/A Dry Flowables 

for MechanicallyPressurized Handgun 

Sprayers

Greenhouse Plants (Foliar)

120

0.00131

lb ai/gal

1000

gallons

0.00198 5,100

Greenhouse Plants 

(Ground/Soil)

0.00475

lb ai/gal 0.00713 1,400

Nursery Plants (Foliar)

3.9

0.00131

lb ai/gal 0.0000640 160,000

Nursery Plants (Ground/Soil) 0.00475

lb ai/gal 0.000231 44,000

Landscaping

(trees/shrubs/bushes)

0.00131

lb ai/gal 0.0000640 160,000

Typical Field Crops (Foliar) 3.9 0.00875

lb ai/gal 0.000426 24,000

Typical Field Crops 

(Ground/Soil) 3.9 0.0175lb ai/gal 0.000854 12,000

Golf Courses

(tees and greens only)

42 0.133 5

acres

0.000348 29,000

Golf Courses

(fairways, tees, and greens)

Landscaping

(turf, lawns, athletic fields, 

parks, etc)

M/L/A Liquids for 

Backpack Sprayers

Orchard (Ground/Soil) 2.58 0.00443

lb ai/gal

40

gallons

0.00000571 1,800,000

Greenhouse Plants (Foliar)

140

0.00326

lb ai/gal

0.000229 44,000

Nursery Plants (Foliar)

Nursery Plants (Ground/Soil) 2.58 0.00000421 2,400,000

Landscaping 

(trees/shrubs/bushes) 140 0.000229 44,000 Landscaping

(plants/flowers)

Landscaping

(turf, lawns, athletic fields, 

parks, etc)

2.58 0.00418

lb ai/gal 0.00000539 1,900,000

Industrial/Commercial Areas 

(tires, rail/junk yards, etc) 30 0.0887

lb ai/gal

0.000133 76,000

Poultry/Livestock 

Houses/Horse Barns/Feedlots

Foundations/Perimeters 2.58 0.0000115 880,000

M/L/A Liquids for 

Manually-Pressurized 

Handwand Sprayers

Greenhouse Plants (Foliar)

30 0.00326

lb ai/gal

40

gallons

0.0000489 210,000

Nursery Plants (Foliar)

Landscaping 

(trees/shrubs/bushes)

Landscaping

(plants/flowers)

Landscaping

(turf, lawns, athletic fields, 

parks, etc) 30 0.00418

lb ai/gal 0.0000626 160,000

Interior Landscaping
Page 32 of 47

Table 6.1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Cyantraniliprole.

Exposure Scenario Crop or Target

a

Baseline 

Inhalation 

Unit 

Exposureb

Maximum

Application 

Ratec

Area 

Treated or 

Amount 

Handled 

Dailyd

Baseline Inhalation

Dosee MOEf

μg/lb ai lb ai/A Acres mg/kg/day ST LOC = 30

IT LOC = 100

Industrial/Commercial Areas 

(tires, rail/junk yards, etc)

30

0.00887

lb ai/gal

0.000133 76,000

Poultry/Livestock 

Houses/Horse Barns/Feedlots

Foundations/Perimeters

Structural Areas (bridges, 

shipyards, home decks, 

foundations)

Warehouses

110 0.00448 2,100

Residential Living Spaces 

(homes, apartments)

Childcare 

Center/Schools/Institutions

M/L/A Liquids for 

MechanicallyPressurized Handgun 

Sprayers

Orchard Crops (Foliar) 3.9 0.00443

lb ai/gal

1000

gallons

0.000216 47,000

Orchard Crops (Ground/Soil) 3.9 0.00449

lb ai/gal 0.000219 46,000

Greenhouse Plants (Foliar)

120

0.00326

lb ai/gal

0.00489 2,100 Greenhouse Plants 

(Ground/Soil)

Nursery Plants (Foliar)

3.9 0.000159 63,000

Nursery Plants (Ground/Soil)

Landscaping 

(trees/shrubs/bushes)

Industrial/Commercial Areas 

(tires, rail/junk yards, etc) 3.9

0.00887

lb ai/gal

0.000433 23,000

Warehouses

79 0.00876 1,200

Poultry/Livestock 

Houses/Horse Barns/Feedlots

Structural (bridges, shipyards, 

home decks, foundations, etc)

Typical Field Crops (Foliar)

3.9 0.00202

lb ai/gal 0.0000985 100,000 Typical Field Crops 

(Ground/Soil)

Golf Courses

(tees and greens only)

1.9 0.313 5

acres

0.0000371 270,000

Golf Courses

(fairways, tees, and greens)

Landscaping

(turf, lawns, athletic fields, 

parks, etc)
Page 33 of 47

Table 6.1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Cyantraniliprole.

Exposure Scenario Crop or Target

a

Baseline 

Inhalation 

Unit 

Exposureb

Maximum

Application 

Ratec

Area 

Treated or 

Amount 

Handled 

Dailyd

Baseline Inhalation

Dosee MOEf

μg/lb ai lb ai/A Acres mg/kg/day ST LOC = 30

IT LOC = 100

Loader/Applicator

L/A Granules for Belly 

Grinders

Orchard Crops

62 0.0871 1

acre

0.0000675 150,000

Greenhouse Plants

Nursery Plants

Landscaping 

(trees/shrubs/bushes)

Landscaping

(plants/flowers)

Landscaping

(turf, lawns, athletic fields, 

parks, etc)

Industrial/Commercial Areas 

(tires, rail/junk yards, etc)

Poultry/Livestock 

Houses/Horse Barns/Feedlots

Foundations/Perimeters

L/A Granules for 

Rotary Spreaders

Orchard Crops

10 0.0871 5

acres

0.0000545 180,000

Greenhouse Plants

Nursery Plants

Golf Courses

(tees and greens only)

Golf Courses

(fairways, tees, and greens)

Landscaping

(turf, lawns, athletic fields, 

parks, etc)

Industrial/Commercial Areas 

(tires, rail/junk yards, etc)

L/A Granules for 

Backpack Sprayers

Nursery Plants

23.8 0.0871 1

acre

Industrial/Commercial Areas 0.000000313 390,000

(tires, rail/junk yards, etc)

L/A Granules for Cups Poultry/Livestock 

Houses/Horse Barns/Feedlots 12.5 0.0871 1acre

0.0000136 740,000

L/A Granules for 

Spoons

Poultry/Livestock 

Houses/Horse Barns/Feedlots 121 0.0871 1acre

0.000131 77,000

a “Typical Field Crops” include Brassica (Cole) leafy vegetables (Group 5), bulb vegetables (Group 3-07), bushberries (Group 13-07B), citrus 

fruits (Group 10-10), cotton, cucurbit vegetables (Group 9), fruiting vegetables (Group 8-10), leafy vegetables (non-Brassica) (Group 4), 

oilseeds (Group 20), pome fruits (Group 11-10), potatoes, stone fruits (Group 12), sunflowers, tree nuts (Group 14), tuberous and corm 

vegetables (Subgroup 1C).

“High-Acreage Field Crops” includes cotton.

“Nursery Plants” include ornamentals, vegetables, trees, container stock.

“Greenhouse Plants” include ornamentals, roses, cut flowers, container stock, vegetables grown for re-sale to consumers.

b Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (March 2012); Level of mitigation = Baseline.

c Based on the maximum application rates on the proposed labels (Reg. Nos. 352-IAE, 352-IAG, 352-IAI, 352-IAL, 253-IAN, 352-ILA, 352-

ILI, 352-ILO, 352-ILT, 100-RUEE, 100-RUEG, 100-RUEN, 100-RUER, 100-RUEU, and 100-RURI).

d Exposure Science Advisory Council Policy #9.1.

e Dermal Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or 

Amount Handled Daily (A or gal/day) × DAF (%) ÷ BW (kg).

f Dermal MOE = Dermal NOAEL (mg/kg/day) ÷ Dermal Dose (mg/kg/day).

g Inhalation Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or 

Amount Handled Daily (A or gal/day) ÷ BW (kg).

h Inhalation MOE = Inhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day).
Page 34 of 47

6.2 Seed Treatment Occupational Handler Exposure/Risk Estimates

HED uses the term handlers to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct job functions or tasks related to 

applications and exposures can vary depending on the specifics of each task. Job requirements 

(amount of chemical used in each application), the kinds of equipment used, the target being 

treated, and the level of protection used by a handler can cause exposure levels to differ in a 

manner specific to each application event. 

Based on the anticipated use patterns and current labeling, types of equipment and techniques 

that can potentially be used, occupational handler exposure is expected from the proposed seed 

treatment uses. The quantitative exposure/risk assessment developed for occupational handlers 

is based on the following scenarios: 

1. Mixing/loading liquids for potato seed piece treatment,

2. Planting potato seed pieces,

3. Mixing/loading liquids for commercial seed treatment, and

4. Planting treated seed.

Occupational seed treatment handlers may experience short- and intermediate-term exposure to

cyantraniliprole while performing seed treatment activities in commercial settings. In addition, 

occupational secondary handlers may experience short- and intermediate-term exposure while 

planting cyantraniliprole-treated seeds. No chemical-specific handler exposure data were 

submitted in support of this use pattern. For assessing commercial seed treatment and seed 

planting activities, unit exposure data were taken from HED ExpoSAC Policy 14: SOPs for Seed 

Treatment. The amount of active ingredient handled depends on the application rate (lb ai/lb 

seed) and the pounds of seed treated in a day (or the pounds of seed that can be planted in a day), 

all of which vary depending upon the seed type. Values for the amount of seed treated and 

planted per day were obtained from HED ExpoSAC Policy 15.

Treating Seed (Primary Handler)

Potential occupational exposure scenarios from the use of cyantraniliprole as a commercial seed 

treatment include: mixing, loading, applying liquid formulations; bagging treated seed; sewing 

bags; and multiple activities. Typically, for large-scale commercial seed treatments, workers 

perform only those specific individual tasks listed above; however, it is assumed that workers 

also may perform multiple activities throughout the day. As a result a “multiple activities” 

scenario (i.e. where one worker performs all seed treatment tasks such as loading/applying, 

sewing, bagging, cleaning, calibration, repair, forklift driver, etc.) was addressed.

Planting Treated Seed (Secondary Handler)

Potential occupational exposure scenarios from the use of cyantraniliprole as a commercial seed 

treatment include planting treated seed (secondary handler). Planting treated seed consists of the 

farmer purchasing bags of treated seed, placing the seed in the hopper and applying seed to fields

(considered a secondary handler exposure scenario).
Page 35 of 47

Potato Seed Piece Treatment

HED considers commercial seed piece treatment to be either at a seed treatment facility or onfarm treatment that utilizes similar equipment. Potato seed piece handling and seed treatment in 

operations large enough to facilitate commercial farm scale planting all utilize equipment that is 

similar in principle and in treatment capability. There are two basic types of machines. In one, 

seed pieces are treated (sprayed) as they move on a conveyer belt through a covered 

(shielded/hooded) machine that applies the spray. The other types of machines are “drums” 

(similar in concept to a concrete mixer) in which the seed pieces are treated as they pass through. 

These types of machines make it possible to treat the large volumes of seed necessary to 

facilitate planting on field scale operations. Most operations intend to treat only enough seed 

that may be planted on a given day.

Large scale (commercial) potato seed piece treatment typically involves the following 

procedures. Seed potatoes are handled with some type of front end loader to dump them into a 

machine that cuts them into “seed pieces”. The pieces emerge on a conveyer where an 

individual(s) sorts and culls the pieces. Pieces too large are cut again by hand and diseased or 

damaged pieces are culled. The seed pieces proceed by conveyer through the spray treatment 

machine as described above. There is no applicator in a typical sense of an individual using any 

type of sprayer to apply the material. It is applied in an automated fashion in a covered device. 

Finally, treated seed is again mechanically loaded in bulk to potato seed planters. Planters are 

similar in concept to other types of machines that plant seeds. Potato planters are basically large 

open bins filled with seed pieces. The pieces pass through complicated “handling” machinery in 

the planter to very precisely deposit properly spaced seed to an optimum depth in a furrow and 

are covered as the planter moves down the row.

Thus, the only occupational pesticide “handler” is the individual who prepares the stock spray 

solution that is used in the enclosed spray applicators. As such, that individual performs 

activities which are essentially the same as those performed by a mixer/loader supporting 

conventional ground or aerial spray operations.

Occupational Handler Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the occupational 

handler risk assessments. Each assumption and factor is detailed below on an individual basis.

Application Rate: 

Refer to the proposed use pattern table in Section 4.0.

Unit Exposures: It is the policy of HED to use the best available data to assess handler exposure. 

Chemical-specific data for assessing exposure during commercial seed treatment and seed 

planting were not submitted to the Agency in support of this Section 3 application. Unit 

exposures are from ExpoSAC Policy 14: SOPs for Seed Treatment (May 1, 2003) and are based 

on data for open mixing/loading/application systems; and D378750 (Potato seed piece handler 

unit exposures).

Amount Handled: 

HED is currently in the process of revising ExpoSAC Policy 15: Amount of Seed Treated or 

Planted per Day (March 2, 2004) in efforts to update the daily amount of seed treated in 
Page 36 of 47

commercial seed treatment facilities. With the increasing demand for hybridized treated seeds, 

there have been modifications not only in the seed treatment equipment, but in the market shares 

of new and currently registered pesticide products. HED understands that due to the high cost of 

producing hybrid seeds, direct seeding is done in a precision manner which requires lower 

volumes of seed per acre. However, this does not provide a direct correlation to the amount of 

seed which is treated in the commercial seed treatment facilities. 

The amount of seed handled (for both primary/treater and secondary/planter handlers) is based 

on HED ExpoSAC Policy 15, HED ExpoSAC Policy SOP 15.1, and the BEAD memo: “Acres 

Planted Per Day and Seeding Rates of Crops Grown in the United States.” Note: It was assumed 

that the amount of potato seed pieces planted per day is equal to the amount treated per day 

because it is not recommended to store potato seed pieces more than a few days after treatment.

The amount of seed treated per day at a commercial facility for short-term exposure duration is 

summarized below for each crop.

Potato Seed Pieces – 800,000 lbs,

Rapeseed/Canola – 125,000 lbs,

Mustard Seed – 125,000 lbs, and

Sunflowers – 339,500 lbs.

The amount of seed planted per day is summarized below for each crop.

Potato Seed Pieces – 800,000 lbs,

Rapeseed/Canola – 400 lbs,

Mustard Seed – 560 lbs, and

Sunflowers – 320 lbs.

Exposure Duration: 

HED classifies exposures from 1 to 30 days as short-term and exposures 30 days to six months 

as intermediate-term.

Mitigation/Personal Protective Equipment: Results are presented for “baseline” (defined as a 

single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no 

protective gloves, and no respirator.

Occupational Handler Non-Cancer Exposure and Risk Estimate Equations

The algorithms used to estimate non-cancer exposure and dose for occupational handlers can be 

found in Appendix A.

Combining Exposures/Risk Estimates

The dermal route of exposure does not need to be combined with the assessed inhalation route of 

exposure or included in the aggregate risk assessment because there is no identified dermal 

hazard.

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates

The results of the occupational handler exposure and risk assessment indicate that short-term 

inhalation risks do not exceed HED’s LOC (i.e. an MOE < 30 for short-term exposures) at 
Page 37 of 47

baseline mitigation (no PPE). Short-term exposure risk estimates are protective of intermediateterm exposure risk estimates because the throughput (amount of seed treated) is greater than, or 

equal to, the throughput of short-term exposure. The calculated inhalation risk estimates do not 

exceed HED’s LOC for intermediate-term exposures (i.e. an MOE < 100) at baseline mitigation 

(no PPE). The inhalation MOEs range from 370 to 190,000 for handlers (treaters and planters).

Table 6.2. Summary of Short-Term Handler Exposures and Risks for Cyantraniliprolea

Seed Type

Max 

Application

Rateb

Inhalation

UEc

Amount of Seed

Treated or 

Planted

Per Dayd

Inhalation

Dosee

Inhalation

MOEf

lb ai/lb seed mg/lb lb seed/day mg/kg/day ST LOC = 30

Loader/Applicator

Potato Seed Pieces 0.000135 0.0064*

800,000 0.00864002 1,200

Rapeseed/Canola 0.0100

0.00034

125,000 0.00531939 1,900

Mustard Seed 0.0100 125,000 0.00531939 1,900

Sunflowers 0.00397 339,500 0.00572580 1,800

Sewer

Rapeseed/Canola 0.0100

0.00023

125,000 0.00359841 2,800

Mustard Seed 0.0100 125,000 0.00359841 2,800

Sunflowers 0.00397 339,500 0.00387333 2,600

Bagger

Rapeseed/Canola 0.0100

0.00016

125,000 0.00250324 4,000

Mustard Seed 0.0100 125,000 0.00250324 4,000

Sunflowers 0.00397 339,500 0.00269449 3,700

Multiple Activities

Rapeseed/Canola 0.0100

0.0016

125,000 0.02503242 400

Mustard Seed 0.0100 125,000 0.02503242 400

Sunflowers 0.00397 339,500 0.02694492 370

Planter

Potato Seed Pieces 0.000135

0.0034

800,000 0.0045900 2,200

Rapeseed/Canola 0.0100 400 0.0001702 59,000

Mustard Seed 0.0100 560 0.0002383 42,000

Sunflowers 0.00397 320 0.0000540 190,000

a Seed treatment rate calculations are based on the following assumptions:

Mustard seed: 90,000 to 115,000 seeds per lb; 7 lbs of seed planted per day, 80 acres planted per day.

Potato seed pieces: 5 to 11 seed pieces per lb; 800,000 seed pieces planted per day.

Rapeseed (canola): 90,000 to 115,000 seeds per lb; 5 lbs of seed planted per day, 80 acres planted per day.

Sunflowers: 2,000 to 9,000 seeds per lb; 4 lbs of seed planted per day, 80 acres planted per day.

b Application Rates based on proposed label uses for cyantraniliprole (EPA Reg. Nos. 352-IAN, 100-RUEN, and 100-RURI).

c Unit Exposures from HED Exposure Science Advisory Council Policy 14: Standard Operating Procedures for Seed Treatment (baseline 

inhalation = no respirator).

* The inhalation unit exposure for potato seed pieces comes from D378750.

d HED default for lb seed treated/planted per day from HED Exposure Science Advisory Council Interim Policy 15.1 and the BEAD memo 

“Acres Planted Per Day and Seeding Rates of Crops Grown in the United States” (J. Becker, March 2011).

e Daily Inhalation Dose (mg/kg/day) = daily inhalation unit exposure (mg/lb ai) × application rate (lb ai/lb seed) × amount planted (lb seed/day) 

÷ body weight (80 kg adult).

f Inhalation MOE = NOAEL (10.08 mg/kg/day for short- and intermediate-term exposure) ÷ Inhalation Dose (mg/kg/day). Short-term level of 

concern = 30.
Page 38 of 47

On-Farm Seed Treatment

On-farm seed treatment utilizes similar machinery as commercial seed treatment; the only 

difference being the size of the equipment. The assessed commercial seed treatment exposure 

and risk is protective of on-farm seed treatment scenarios.

6.3 Occupational Post-Application Exposure/Risk Estimates

HED uses the term post-application to describe exposures that occur when individuals are 

present in an environment that has been previously treated with a pesticide (also referred to as reentry exposure). Such exposures may occur when workers enter previously treated areas to 

perform job functions, including activities related to crop production, such as scouting for pests 

or harvesting. Post-application exposure levels vary over time and depend on such things as the 

type of activity, the nature of the crop or target that was treated, the type of pesticide application, 

and the chemical’s degradation properties. In addition, the timing of pesticide applications, 

relative to harvest activities, can greatly reduce the potential for post-application exposure.

An occupational post-application dermal exposure and risk assessment was not conducted 

because a dermal hazard was not identified for cyantraniliprole.

With regard to seed treatment, the potential for post-application exposures following the planting 

of cyantraniliprole-treated seeds is unlikely because sustained levels of contact with treated seed 

after it has been placed in the soil or other planting media would not be expected because no 

routine cultural practice required for the production of agricultural commodities involves such an 

activity as defined in the no/low contact criteria in the Worker Protection Standard (WPS). 

Therefore, no quantitative post-application assessment is required for exposure to treated seeds 

that have already been planted.

Occupational Post-Application Inhalation Exposure/Risk Estimates

Based on the Agency's current practices, a quantitative post-application inhalation exposure 

assessment was not performed for cyantraniliprole at this time primarily because of the low acute

inhalation toxicity (Toxicity Category IV), low vapor pressure (3.85×10-17 mm Hg at 20oC), and 

the low proposed use rate (0.391 lb ai/A). However, there are multiple potential sources of postapplication inhalation exposure to individuals performing post-application activities in 

previously treated fields. These potential sources include volatilization of pesticides and 

resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert 

advice and input on issues related to volatilization of pesticides from its Federal Insecticide, 

Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and 

received the SAP’s final report on March 2, 201011. The Agency is in the process of evaluating 

the SAP report as well as available post-application inhalation exposure data generated by the 

ARTF and may, as appropriate, develop policies and procedures, to identify the need for and, 

subsequently, the way to incorporate occupational post-application inhalation exposure into the 

Agency's risk assessments. If new policies or procedures are put into place, the Agency may 

revisit the need for a quantitative occupational post-application inhalation exposure assessment 

for cyantraniliprole.

 

11 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html
Page 39 of 47

Although a quantitative occupational post-application inhalation exposure assessment was not 

performed, an inhalation exposure assessment was performed for occupational/commercial 

handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in 

higher exposure than post-application exposure. Therefore, it is expected that these handler 

inhalation exposure estimates would be protective of most occupational post-application 

inhalation exposure scenarios.

Greenhouse Uses

The Worker Protection Standard for Agricultural Pesticides contains requirements for protecting 

workers from inhalation exposures during and after greenhouse applications through the use of 

ventilation requirements.12

Indoor Commercial Uses

Commercial applicators do not typically return to the treated areas after an indoor commercial 

pesticide application (sites such as warehouses, food handling establishments, and hotels, etc.) 

and thus an occupational post-application inhalation exposure assessment was not performed for 

commercial applicators.

Seed Treatment Uses

A post-application inhalation exposure assessment is not required as exposure is expected to be 

negligible. Seed treatment assessments provide quantitative inhalation exposure assessments for 

seed treaters and secondary handlers (i.e. planters). It is expected that these exposure estimates 

would be protective of most post-application inhalation exposure scenarios.

6.4 Restricted Entry Interval

Cyantraniliprole is classified as Toxicity Category IV via the dermal route. It is not irritating to 

the skin and it is not a skin sensitizer. Typically, the REI specified on the proposed label is 

based on the acute toxicity of the active ingredient. Under 40 CFR 156.208 (c) (2) (iii), active 

ingredients classified as Acute III or IV for acute dermal, eye irritation and primary skin 

irrigation are assigned a 12-hour REI. However, REIs may be further reduced from 12 hours if 

certain criteria are met for both the technical material and the different end-use products in 

accordance with the Pesticide Registration (PR) Notice 95-3 [Reduction of Worker Protection 

Standard (WPS) Interim Restricted Entry Intervals (REIs) for Certain Low Risk Pesticides].13 

The criteria for reducing REIs include the following:

(1) The active ingredient is in Toxicity Category III or IV based upon data for acute dermal 

toxicity, acute inhalation toxicity, primary skin irritation, and primary eye irritation.

(2) The active ingredient is not a dermal sensitizer.

(3) The active ingredient is not a cholinesterase inhibitor.

(4) The active ingredient is not associated with known reproductive, developmental, 

carcinogenic, or neurotoxic effects.

(5) EPA does not possess incident information that are “definitely” or “probably” related to 

the post-application exposures to the active ingredient.

 

12 40 CFR 170.110, (3) (Restrictions associated with pesticide applications)

13 Available: http://www.epa.gov/PR_Notices/pr95-3.html
Page 40 of 47

With respect to the active ingredient, cyantraniliprole, these criteria have been met for the 

technical and all but two of the proposed EPs. Since the two products, EPA Reg. No. 352-ILT 

and EPA Reg. No. 352-ILI, have been identified as dermal sensitizers, a 12-hour REI is required 

to protect agricultural workers from post-application exposures to cyantraniliprole. Aside from 

these two products, a 4-hour REI is adequate. Table 6.4 shows the acute toxicity results for each 

proposed label and formulation.

Table 6.4. Acute Toxicity Results of All Proposed U.S. Registrations for Cyantraniliprole

EPA

Reg. No. Formulation Oral Dermal Inhalation Skin Irritation Eye Irritation Sensitization

352-ILA 96.7% technical IV IV IV IV IV -ve

352-ILT 100 g/l OD IV IV IV IV III +ve

352-ILO 100 g/l SE IV IV IV III III +ve

352-IAN 200 g/l SC IV IV IV IV IV -ve

352-ILI 625 g/l FS IV IV IV IV IV -ve

352-IAE 0.5% RB IV IV waivedaIV IV -ve

352-IAI 200 g/l SC IV IV IV IV IV -ve

352-IAL 200 g/l SC IV IV IV IV IV -ve

352-IAG 200 g/l SC IV IV IV IV IV -ve

100-RUER 200 +200 g/kg WG IV IV IV IV III -ve

100-RUEE 200 +200 g/kg WG IV IV IV IV III -ve

100-RUEG 200 +200 g/kg WG IV IV IV IV III -ve

100-RUEU 200 +200 g/kg WG IV IV IV IV III -ve

100-RUEN 600 g/l FS IV IV IV IV IV -ve

100-RURI 600 g/l FS IV IV IV IV III -ve

a Waiver request granted (Technical = Tox Cat IV; Bait station, no potential for inhalation exposure, etc.)
Page 41 of 47

Appendix A. Summary of Occupational Handler Non-Cancer Algorithms

Average Daily Dose

Potential daily exposures for occupational handlers are calculated using the following formulas:

where:

E = exposure (mg ai/day),

UE = unit exposure (μg ai/lb ai),

AR = maximum application rate according to proposed label (lb ai A or lb ai/gal), and

A = area treated or amount handled (e.g., A/day, gal/day).

The daily doses are calculated using the following formula:

where:

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day),

E = exposure (mg ai/day),

AF = absorption factor (dermal and/or inhalation), and

BW = body weight (kg).

Margin of Exposure

Non-cancer risk estimates for each application handler scenario are calculated using a Margin of 

Exposure (MOE), which is a ratio of the toxicological endpoint to the daily dose of concern. The 

daily dermal and inhalation dose received by occupational handlers are compared to the 

appropriate POD (i.e., NOAEL) to assess the risk to occupational handlers for each exposure 

route. All MOE values are calculated using the following formula:

where:

MOE = margin of exposure: value used by HED to represent risk estimates (unitless),

POD = point of departure (mg/kg/day), and

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day).
Page 42 of 47

Appendix B. Summary of Residential Post-Application Non-Cancer Algorithms

Dose, normalized to body weight, is calculated as:

BW

E

D

where:

D = dose (mg/kg/day);

E = exposure (mg/day); and

BW = body weight (kg).

Post-Application Hand-to-Mouth Exposure Algorithm for Physical Activities on Turf

Exposure from hand-to-mouth activity is calculated as follows (based on the algorithm utilized in 

the SHEDS-Multimedia model):

E = [HR * (FM * SAH) * (ET * N_Replen) * (1- (1- SE)

(Freq_HtM/N-Replen))]

where:

E = exposure (mg/day);

HR = hand residue loading (mg/cm2);

FM = fraction hand surface area mouthed / event (fraction/event);

SAH = typical surface area of one hand (cm2);

ET = exposure time (hr/day);

N_Replen = number of replenishment intervals per hour (intervals/hour);

SE = saliva extraction factor (i.e., mouthing removal efficiency); and

Freq_HtM = number of hand-to-mouth contacts events per hour (events/hour).

and

SA * 2

Fai *DE

HR

H

hands

where:

HR = hand residue loading (mg/cm2);

Faihands = fraction ai on hands compared to total surface residue from dermal transfer coefficient 

study (unitless);

DE = dermal exposure (mg); and

SAH = typical surface area of one hand (cm2).

Post-Application Object-to-Mouth Exposure Algorithm for Physical Activities on Turf

Exposure from object-to-mouth activity is calculated as follows (based on the algorithm utilized 

in SHEDS-Multimedia):

E = [OR* CF1 * SAMO * (ET * N_Replen) * (1- (1- SEO)

(Freq_OtM/N_Replen))]

where:

E = exposure (mg/day);

OR = chemical residue loading on the object on day “t” (ug/cm2);

CF1 = weight unit conversion factor (0.001 mg/μg);

SAMO = area of the object surface that is mouthed (cm2/event);

ET = exposure time (hr/day);

N_Replen = number of replenishment intervals per hour (intervals/hour);

SEO = saliva extraction factor (i.e., mouthing removal efficiency); and
Page 43 of 47

Freq_OtM = number of object-to-mouth contact events per hour (events/hour).

and

OR = AR * FO * CF2 * CF3

where:

OR = chemical residue loading on the object (μg/cm2);

AR = application rate (lbs ai/ft2or lb ai/acre);

FO = fraction of residue available on the object (unitless);

CF2 = weight unit conversion factor (4.54 x 108μg/lb); and

CF3 = area unit conversion factor (1.08 x 10-3ft2/cm2or 2.47 x 10-8acre/cm2).

Post-Application Incidental Soil Ingestion Exposure Algorithm for Physical Activities on Turf

Exposure from incidental soil ingestion is calculated as follows:

E = SRt * SIgR * CF1

where:

E = exposure (mg/day);

SRt = soil residue on day "t" (μg/g);

SIgR = ingestion rate of soil (mg/day); and

CF1 = weight unit conversion factor (1 x 10-6g/μg).

and

SRt = AR * FS * (1-FD)

t

* CF2 * CF3 * CF4

where:

SRt = soil residue on day "t" (μg/g);

AR = application rate (lbs ai/ft2or lb ai/acre);

FS = fraction of ai available in uppermost cm of soil (fraction/cm);

FD = fraction of residue that dissipates daily (unitless);

T = post-application day on which exposure is being assessed;

CF2 = weight unit conversion factor (4.54 x 108μg/lb);

CF3 = area unit conversion factor (1.08 x 10-3ft2/cm2 or 2.47 x 10-8acre/cm2); and

CF4 = soil volume to weight unit conversion factor (0.67 cm3/g soil).

Post-Application Hand-to-Mouth Exposure Algorithm for Indoor Environments

Exposure from hand-to-mouth activity is calculated as follows (based on algorithm utilized in 

SHEDS-Multimedia):

where:

E = exposure (mg/day);

HR = hand residue loading (mg/cm2);

FM = fraction hand surface area mouthed / event (fraction/event);

ET = exposure time (hr/day);

SAH = surface area of one hand (cm2);

N_Replen = number of replenishment intervals per hour (intervals/hour);

SE = saliva extraction factor (i.e., mouthing removal efficiency); and

Freq_HtM = number of hand-to-mouth contacts events per hour (events/hour).

and
Page 44 of 47

where:

HR = hand residue loading (mg/cm2);

Faihands = fraction ai on hands compared to total surface residue from jazzercise study (unitless);

DE = dermal exposure (mg); and

SAH = typical surface area of one hand (cm2).

Post-Application Object-to-Mouth Exposure Algorithm for Indoor Environments

Exposure from object-to-mouth activity is calculated as follows (based on algorithm utilized in 

SHEDS-Multimedia):

where:

E = exposure (mg/day);

OR = chemical residue loading on an object ( g/cm2);

CF1 = weight unit conversion factor (0.001 mg/ g);

SAMO = area of the object surface that is mouthed (cm2/event);

ET = exposure time (hr/day);

N_Replen = number of replenishment intervals per hour (intervals/hour);

SE = saliva extraction factor (i.e., mouthing removal efficiency); and

Freq_OtM = number of object-to-mouth contact events per hour (events/hour).

and

where:

OR = chemical residue loading on the object (μg/cm2);

DepR = deposited residue (μg/cm2); and

FO = fraction of residue transferred to an object (unitless).
Page 45 of 47

Appendix C. Human Equivalent Concentrations and Human Equivalent Dose 

Calculations

The HEC and human equivalent dose calculations were based on the results of a 28-day rat 

inhalation study in rats (MRID 48697401). In this study, cyantraniliprole was administered (as 

an aerosol) to Crl:CD(SD) rats (10/sex/dose) for 6 hours/day, 5 days/week, for 4-weeks. The test 

animals were exposed nose-only to target concentrations of 0 (air control), 1, 10, or 100 mg/m3 

of cyantraniliprole (equivalent to 0.001, 0.01, and 0.1 mg/L, respectively). Adverse effects were 

not seen at any concentration tested, although laryngeal metaplasia was considered treatment 

related but not adverse at 0.1 mg/L. The NOAEL was 0.1 mg/L.

RDDR for Cyantraniliprole

Calculations used to estimate the inhalation risk to humans from aerosols are dependent not on

the regional gas dose ratio (RGDR) as for gases, but on the regional deposited dose ratio 

(RDDR). Inhalation studies using aerosols characterize particulate exposure by defining the 

particulate diameter [mass median aerodynamic diameter (MMAD)] and the geometric standard 

deviation (σg), which is then used to determine the RDDR. The RDDR is a multiplicative factor 

used to adjust an observed inhalation particulate exposure concentration of an animal (A) to the 

predicted inhalation particulate exposure concentration for a human (H) that would be associated 

with the same dose delivered to the affected region (r) or target tissue.

RDDRr = (RDDr/Normalizing Factor)A / (RDDr/Normalizing Factor)H

As with calculations for gases, the affected regions and potential target tissues are the three 

respiratory regions (extrathoracic, tracheobronchial, and pulmonary). The RDDR is easily 

calculated by using a software program designed specifically for computing the RDDR from the 

MMAD and σg defined from an aerosol inhalation study. The values for the species-specific 

parameters used to calculate the RDDR are provided in the EPA document “Methods for 

Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry.” 

The magnitude of the UFs applied is dependent on the methodology used to calculate risk. The 

RfC methodology takes into consideration the PK differences, but not the PD differences. 

Consequently, the UF for interspecies extrapolation may be reduced to 3X (to account for the PD 

differences) while the UF for intraspecies variation is retained at 10X. Thus, the UF when using 

the RfC methodology is customarily 30X.

Regional Deposited Dose Ratio (RDDR) 

MMAD = 3.00

Sigma g = 2.30

SPECIES Body Weight (g) Minute Ventilation (VE, ml) deposited fraction

rat 236 171.5 0.587

human 70000 13800.0 0.759

RATIO 0.734

RDDR = (VE/SA)animal ÷ (VE/SA)human × deposited fractionanimal ÷ deposited fractionhuman

= (171.5/236)animal ÷ (13800/70000)human × 0.587 ÷ 0.759

= 2.8
Page 46 of 47

Example for HEC calculations for short-term occupational exposure:

Assume workers will be in the greenhouse for 8 hrs/day and 5 days/week:

HEC = NOAELstudy × (daily duration of exposureanimal ÷ daily duration of exposurehuman) × (days/week of 

exposureanimal ÷ days/week of exposurehuman) × RDDR

HEC = 0.1 mg/L × (6 ÷ 8) × (5 ÷ 5) × 2.8 = 0.21 mg/L

Table B.4. HEC Array for Non-Occupational and Occupational Risk Assessment

Relevant Study LOAEL

(mg/L)

NOAEL

(mg/L) Da Dh Wa Wh RDDR HEC (mg/L) inter intra UF

Short-& Intermediate-Term Occupational Exposure

Inhalation – Rat

(MRID 48697401 ) 28-day Not Obs. 0.1 6 8 5 5 2.8 0.21 3 10 NA

Short-& Intermediate-Term Non-Occupational (Residential) Exposure

Inhalation – Rat

(MRID 48697401 ) 28-day Not Obs. 0.1 6 24 5 7 2.8 0.05 3 10 NA

Long Term Exposure: Not Appropriate

Key:

LOAEL: Lowest observed adverse effect level

Da: Daily animal exposure (hrs/day)

Wa: Weekly animal exposure (days/week)

RRDR: Regional Deposited Dose Ratio

inter: interspecies extrapolation uncertainty factor

Dh: Anticipated daily human exposure (hrs/day)

Wh: Anticipated weekly human exposure (days/week)

HC: Human Concentration

HEC: Human Equivalent Concentration

intra: intraspecies variation uncertainty factor

UF: Other uncertainty factor(s)

Summary of Human Equivalent Concentrations

Occupational Short-Term

Study

NOAEL (m/L)

systemic

RDDR

Daily Duration

(6 hrs rat/8 hrs 

human)

Weekly (days/week)

Duration (rat 5 days/human 5 days)

HEC 

(mg/L) UF

28-day rat 0.1 2.8 0.75 1 0.21 30

Non-Occupational Short-Term

Study

NOAEL (m/L)

systemic

RDDR

Daily Duration

(6 hrs rat/24 hrs 

human)

Weekly (days/week)

Duration (rat 5 days/human 7 days)

HEC 

(mg/L) UF

28-day rat 0.1 2.8 0.25 0.714 0.05 30

Human Equivalent Doses

The HEC is in mg/L but exposure data are in mg/kg/day. Therefore, conversion of the human 

mg/L value to human mg/kg/day was conducted as follows: 

Inhalation to Oral Equation:

dose (systemic HEC value) mg/L × A × CF (L/hr/kg) × D (hours) × AF = mg/kg;
Page 47 of 47

Occupational: (0.21 mg/L) × 1 × 6 × 8 × 1 = 10.08 mg/kg/day 

Residential: (0.05 mg/L) × 1 × 6 × 24 × 1 = 7.2 mg/kg/day 

Where:

A absorption: ratio of deposition and absorption in respiratory tract compared to absorption by the oral route. A 

default A of 1 was used.

CF Conversion Factor: A L/hr/kg factor which accounts for respiratory volume and body weight for a given 

species and strain (A human conversion factor of 6 for ages 10-30 yrs was used for both occupational and nonoccupational calculations).

D Duration: Duration of daily animal or human exposure (hours). The default assumption for occupational is 8 

hrs while non-occupational could potentially be 24 hrs.

AF Activity Factor: The default human activity factor is 1.