Cyantraniliprole 

PC Code 090098 

Dietary Exposure and Risk Assessment DP# 407963 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

DRAFT MEMORANDUM 

Date: 01129/2013 

SUBJECT: Cyantraniliprole: Chronic Aggregate Dietary (Food plus Drinking Water) 

Exposure and Risk Assessments for the First Food Uses in Support of a Section 3 

Registration Action on Brassica (cole) Leafy Vegetables (Group 5), Bulb 

Vegetables (Group 3-07), Bushberries (Group 13-07B), Oilseed (Group 20), 

Citrus Fruit (Group 10-10), Cotton, Cucurbit Vegetables (Group 9), Fruiting 

Vegetables (Group 8-10), Leafy Vegetables (non-Brassica) (Group 4), Pome 

Fruit (Group 11-10), Stone Fruit (Group 12), Tree Nuts (Group 14), and 

Tuberous and Corm Vegetables (Subgroup 1 C). 

PC Code: 090098 

Decision No.: 451670 

DP Barcode: D407963 

Registration Nos.: 352-ILA, 352-ILT, 352-

ILO, 352-IAN, 352-ILI, 352-IAT 

Regulatory Action: Section 3 Registration 

CaseNo.: NA 

Petition No.: 1F7894 

Risk Assessment Type: Dietary 

TXRNo.: NA CAS No.: 736994-63-1 

MRIDNo.: NA 40 CFR: §180.XXX 

FROM: 

THROUGH: 

TO: 

Meheret Negussie, Chemist /tel. ere~- ~7!~-e_ 

Risk Assessment Branch III 

Health Effects Division (7509P) 

David Hrdy, Senior Scientist~~ s..l;$ /VII--"'!.-/ 

ldeliz Negron-Encarnacion Ph~~~~ ist (____, 

Dietary Exposure Science Advisory Council (DE C) 

Health E!~cts Division (HED; 7509P;a ~ • 

Christine Olinger, Branch Chief {_;#~ LJohn Hebert/ Thomas Harris, RM07 

Insecticide Branch 

Registration Division (7505P) 

and 

Nancy Tsaur, Chemist/Risk Assessor 

RAB3/HED (7509P) 

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Cyantraniliprole 

PC Code 090098 

I. Executive Summary 

Dietary Exposure and Risk Assessment DP#407963 

Chronic aggregate dietary (food and drinking water) exposure and risk assessment was 

conducted using the Dietary Exposure Evaluation Model software with the Food 

Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 

food consumption data from the U.S. Department of Agriculture's (USDA's) National 

Health and Nutrition Examination Survey, What We Eat in America, 

(NHANES/WWEIA). The analyses were conducted in support of a human health risk 

assessment for the proposed Section 3 requests on numerous commodities, including 

berries, Brassica vegetables, bulb vegetables, canola, citrus, cotton, cucurbits, fruiting 

vegetables, leafy vegetables, pome fruit, potatoes, stone fruits, sunflower, and tree nuts 

(See Table 1 for details). This memorandum was reviewed by two peer reviewers of the 

DESAC, per DESAC SOP 2012.1. 

Cyantraniliprole· is a new active ingredient; therefore, this is the first dietary exposure 

assessment by OPP. 

Acute and Cancer Dietary Exposure 

No acute dietary toxicity endpoint could be identified based on the toxicology data 

currently available for cyantraniliprole; therefore, an acute assessment was not 

performed. 

The Cancer Assessment Review Committee (CARC) classified cyantraniliprole as "not 

likely to be carcinogenic to humans"; therefore, a cancer assessment was not performed. 

Chronic Dietary Exposure Results and Characterization 

Refined chronic (food and drinking water) dietary assessment was conducted assuming 

average field trial residues for all proposed crops (except crop subgroup 1A) and that 

100% of crops are treated (CT). Tolerance level residues were adequate to cover residues 

in all livestock commodities except liver and meat by products for which a higher residue 

level was used based on anticipated residue calculations. The chronic assessment 

incorporated empirical processing factors if available or DEEM version 7.81 default 

processing factors as appropriate. Empirical processing factors were used for potato 

flakes and chips, tomatoes (paste, puree, dried, and juice), orange juice, apple juice, 

cottonseed oil, citrus oil, and dried plums. The processing factors for these commodities 

were set at 1 because the input values included combined residues of the parent and the 

metabolite with relevant processing factors. Crop field trial data depicting residues in/on 

the peel of citrus fruits (lemon peel and orange peel) was available; these values were 

included into the assessment. Estimated drinking water concentration (EDWC) was 

incorporated directly into the dietary assessment using the 1-in-1 0 year annual mean of 

24.45 Jlg/L from surface water estimates obtained using the FIRST model. 

The results of this chronic analysis indicate that chronic dietary (food and drinking water) 

exposure and risk does not exceed HED's level of concern for the U.S. population and all 

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Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

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population subgroups. The results of the DEEM-FCID analysis indicate that the risks are 

about 22% of the chronic population-adjusted dose (cPAD) for the general U.S. 

population and 50% of the cPAD for children (1-2 years old), the most highly exposed 

subgroup.

Introduction

Dietary risk assessment incorporates both exposure and toxicity for any given pesticide. 

For acute and chronic assessments, the risk is expressed as a percentage of a maximum 

acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable 

adverse health effects). This dose is referred to as the population-adjusted dose (PAD). 

The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by 

the required uncertainty or safety factors.

For non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 100% of the cPAD. References which discuss chronic risk assessments in more 

detail are available on the EPA/pesticides web site: “Available Information on Assessing 

Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link: 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf or see SOP 99.6 

(20-AUG-1999).

This is the first DEEM-FCID analysis conducted for cyantraniliprole.

II. Residue Information

Cyantraniliprole is a second generation ryanodine receptor insecticide. The crops 

proposed in the U.S. include berries, citrus, cotton, oilseeds, pome fruits, stone fruits, tree 

nuts, and various vegetables. 

The residue of concern for tolerance enforcement in plants and livestock is the parent 

compound. The residues of concern for risk assessment in processed commodities are the 

parent compound and the metabolite IN-J9Z38. The residues of concern for risk 

assessment in ruminants are the parent compound, IN-N7B69, IN-MLA-84, IN-MYX98, 

and IN-J9Z38. Refer to (DP# D407961, S. Funk, 01/25/2013) for names and structures.

The residues of concern for drinking water assessment are the parent and numerous 

degradates. The degradates IN-J9Z38, IN-NXX69, IN-QKV54, IN-RNU71, IN-JSE76, 

IN-JCZ38, IN-K5A78, IN-K5A77, IN-K5A79, and IN-PLT97 were included in the 

tolerance expression. In the absence of toxicity data and similar analogs, these 

degradates are considered no more toxic than the parent compound and the total residue 

approach (TTR) was recommended for risk assessment purposes. (ROCKS D404411,

July 24, 2012).
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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Residue Data used for Chronic Assessments:

HED used average field trial residues for all proposed crops (except crop subgroup 1A) 

and 100% CT. Anticipated residues were calculated for livestock commodities; however 

tolerance level residues were used for all commodities except meat byproducts and liver

since tolerance was sufficient to cover all the residues of concern. The chronic 

assessment incorporated empirical processing factors if available or DEEM version 7.81

default processing factors as appropriate. Empirical processing factors were used for 

potato flakes and chips, tomatoes (paste, puree, dried, and juice), orange juice, apple 

juice, cottonseed oil, citrus oil, and dried plums. The processing factors for these 

commodities were set at 1 because the input values included combined residues of the 

parent and the metabolite with relevant processing factors. DEEM default processing 

factors were used for onion-dehydrated or dried (9.0), grapefruit juice (2.1), lemon juice 

(2.0), dried apple (8.0), cherry juice (1.5), dry pear (6.25), dry apricot (6.0), dry peach 

(7.0), and plum juice (1.4). Crop field trial data depicting residues in/on the peel of citrus 

fruits (lemon peel and orange peel) was available; these values were included into the 

assessment. The EDWC was incorporated directly into the dietary assessment using the 

1-in-10 year annual mean of 24.45 μg/L. Average field trial values were translated from 

the representative commodities to the other commodities according to HED DESAC SOP 

2000.1. 

Processed Commodities:

Average cyantraniliprole and the metabolite (IN-J9Z38) residues in the raw agricultural 

commodity (RAC) were multiplied by relevant processing factors to obtain the estimate 

of residues in the food as consumed. The result is combined and the total residue is used 

in the dietary assessment. 

Meat, Milk, Poultry and Eggs:

Anticipated residues were calculated for milk fat, kidney, liver, meat, and meat 

byproducts. Based on the dietary burden for livestock; livestock tolerances are 

recommended (DP# D407961, S. Funk, 01/25/2013). Although the anticipated residues 

(parent plus metabolites of concern) of cyantraniliprole were calculated, tolerance levels 

which were based on parent cyantraniliprole were adequate to cover expected residues in 

all commodities (except liver and meat by products).

For meat byproducts and liver the recommended value for risk assessment is 0.02 ppm; 

the highest anticipated residue. Tolerances for swine and poultry are not needed for this 

petition. Based on the ROCKS (D404411, July 24, 2012), metabolites (IN-N7B69, INMLA-84, IN-MYX98, and IN-J9Z38) should be included for risk assessment purposes. 

Refer to Attachment 3 for calculation. 
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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Summary of Dietary Exposure Input Data 

All crops are assumed to be 100%CT and default DEEM (ver. 7.81) and empirical

processing factors were used as appropriate. Table 1 presents the residue values for the 

proposed uses. The complete details of HED recommendations are presented in the 

Summary Memo (DP# D407961, S. Funk, 01/25/2013) and Attachment 3 of this 

memorandum which provides the estimate of the anticipated residues.

Table 1. Residue Data Used for Cyantraniliprole Chronic Analyses.

Matrix Tolerance 

Level 

(ppm)

Highest 

Average 

Field 

Trial 

Residue 

(ppm)

Average 

Field Trial 

Residue 

(ppm)

Anticipated

Residue (AR)

1,2

Experimental 

Processing Factors

Root and tuber vegetables 

(Crop subgroup 1C)

0.15 0.110 0.024

Potato flakes and 

chips

P = 0.024

M = 0.011

0.0254 Cyantraniliprole (P) 

= 0.6 flakes, chips

IN-J9Z38 (M) = 1

flakes, chips

Crop subgroup 1A (Inadvertent 

Residue)

0.02

Onion, bulb Crop Subgroup 3-

07A

0.04 0.027 0.015

Onion, green Crop Subgroup 3-

07B

8.0 4.1 1.60

Crop Group 4 20

Head Lettuce 5 2.7 0.955

Leaf Lettuce 15 6.8 4.43

Celery 15 9.1 2.783

Spinach 20 13.0 6.243

Brassica, head and stem

Crop Subgroup 5A

3.0

Head Cabbage 2.0 0.95 0.556

Broccoli 3.0 1.1 0.743

Brassica, leafy greens

Crop Subgroup 5B

Mustard Greens 30 19 7.391

Fruiting Vegeatbles Crop 

Group 8 2.0

Tomato 1.0 0.620 0.239 P = 3.5 Sundried; 

0.09 Juice; 0.60 

Paste; 0.19 Puree

M = 2.7 Dried; 1 

Juice; 4.2 Paste; 1.3 

Puree

Tomato, sundried P = 0.239

M = 0.010

0.864

Tomato, juice 0.032

Tomato, paste 0.185

Tomato, puree 0.058

Bell Pepper 0.5 0.280 0.119

Non-bell Pepper 2.0 1.0 0.343

Cucurbit Vegetables Crop 0.4
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Table 1. Residue Data Used for Cyantraniliprole Chronic Analyses.

Matrix Tolerance 

Level 

(ppm)

Highest 

Average 

Field 

Trial 

Residue 

(ppm)

Average 

Field Trial 

Residue 

(ppm)

Anticipated

Residue (AR)

1,2

Experimental 

Processing Factors

Group 9

Cucumber 0.3 0.160 0.057

Muskmelon 0.4 0.185 0.110

Squash 0.2 0.110 0.061

Citrus Fruits Crop Group 10 0.7

Grapefruit 0.5 0.310 0.157

Lemon 0.6 0.300 0.198

Lemon-peel N/A 0.625 P = 0.413

M = 0.010

0.423

Orange 0.7 0.390 0.209 P = 0.08 Juice; 6.2 

Oil 

M = 1 Juice; 7.5 Oil

Orange Juice P = 0.209

M = 0.010

0.027

Citrus Oil 2.4 1.371

Orange-peel N/A 0.885 P = 0.463

M = 0.010

0.473

Pome Fruits Crop Group 11 1.5

Apple 0.5 0.310 0.168 P = 0.32 Juice; 1.4 

Applesauce 

M = 1 Juice; 35 

Applesauce

Apple, juice P = 0.168

M = 0.010

0.064

Apple, sauce 0.585

Pear 1.5 0.580 0.278

Stone Fruits Crop Group 12

Cherry subgroup 12-

12A

6.0 3.800 1.179

Peach subgroup 12-

12B

1.5 0.960 0.386

Plum subgroup 12-

12C

0.5 0.280 P = 0.104

M = 0.010

Plum, prune, dried 0.17 P = 1.5 Dried

M = 1.4 Dried

Berries and small fruits, 

bushberries (crop subgroup 13-

07B)

4 2.0 0.888

Tree Nuts Crop Group 14 0.04

Almond 0.04 0.023 0.013

Pecan 0.01 0.010 0.010

Oilseeds Crop group 20 1.5

Cotton, Seed 1.5 0.990 P = 0.212

M = 0.010

0.0238 P = 0.006 Refined oil

M = 1.5 Refined oil

Cotton seed, oil

Canola 0.8 0.61 0.157

Sunflower Seed 0.5 0.320 0.10

Livestock Tolerances/Anticipated Residues
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

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Table 1. Residue Data Used for Cyantraniliprole Chronic Analyses.

Matrix Tolerance 

Level 

(ppm)

Highest 

Average 

Field 

Trial 

Residue 

(ppm)

Average 

Field Trial 

Residue 

(ppm)

Anticipated

Residue (AR)

1,2

Experimental 

Processing Factors

Milk 0.01 0.01

Fat (cattle, goat, and sheep) 0.01 0.01

Meat (cattle, goat, sheep, and 

horse)

0.01 0.01

Kidney (cattle, goat, and sheep) NA 0.01

Liver (cattle, goat, and sheep) NA 0.02

Meat byproducts (cattle, goat, 

and sheep)

0.01 0.02

2

1 AR for processed commodities AR = Cyantraniliprole (Average Residue) X Median Processing Factor (PF) + INJ9Z38 (Average Residue) X Median PF; Residue of concern for processed commodities are parent and the metabolite 

(IN-J9Z38).

2AR for livestock commodities. Based on anticpated residues on liver a value of 0.02 ppm is used for meat byproducts 

(cattle, goat, and sheep).

III. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by EFED 

(DP403747, C. Koper, 11/21/2012) and incorporated directly into this dietary assessment. 

Water residues were incorporated in the DEEM-FCID into the food categories “water, 

direct, all sources” and “water, indirect, all sources.” The EDWC for surface water was 

estimated to be 24.45 ppb. This value is the one in ten-year annual mean. For drinking 

water derived from groundwater for the parent cyantraniliprole, the SCI-GROW 

(Screening Concentration in Ground Water) model estimated the ground water 

concentration at 6.33 ug/L. 

EDWCs for the chronic assessments were estimated using two EFED Tier I screening 

models. For surface water, the FIRST (FQPA Index Reservoir Screening Tool) 

Version1.1.1 model was used to estimate drinking water concentrations. For ground 

water, the SCI-GROW model Program Version 2.3 was used to predict the maximum 

acute and acute concentrations present in shallow ground water. The model and its 

description are available at the EPA internet site: 

http://www.epa.gov/oppefed1/models/water/. 

Based on FIRST and SCI-GROW modeling, the surface and ground water EDWCs for 

the parent cyantraniliprole for various uses are presented in Table 2. 
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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Table 2. Cyantraniliprole Estimated Drinking Water Concentrations (EDWCs)1for Surface Water

and Ground Water based on Proposed Crop Uses

Drinking Water 

Source (Model) Label Use Method

Application 

Rate

(interval 

between 

applications)

Peak Day 

(acute) 

Concentr

ation 

(μg/L)

Annual 

Average

(chronic) 

Concentr

ation 

(μg/L)

Surface Water 

(FIRST)

352-ILT

352-ILO

Various 

Crops Aerial

3 app @ 0.133 

a.i./acre

(5 days)

40.77 23.11

352-IAN Citrus

Vegetables Chemigation

1 app @ 0.4 

a.i./acre

(NA)

40.75 23.09

352-ILI Canola

Mustard Seed Treatment

1 app @ 0.4 

a.i./acre

(NA)

40.75 23.09

352-IAE Fly Control Bait Stations

5 app @ 0.087 

a.i./acre

(7 days)

43.14 24.45

100-RUEN

100-RURI Potato Seed Treatment

1 app @ 0.468 

a.i./acre

(NA)

23.84 13.51

Ground Water 

(SCI-GROW)

352-ILT

352-ILO

Various 

Crops Aerial

3 app @ 0.133 

a.i./acre

(5 days)

5.40 5.40

100-RUEN

100-RURI Potato Seed Treatment

1 app @ 0.468 

a.i./acre

(NA)

6.33 6.33

Bold values denote maximum Estimated Drinking Water Concentrations (EDWCs)

1

Percent Cropped Area (PCA) Adjustment Factor = 1 for surface water estimates following updated PCA

guidance document (2012).

NA = Not Applicable

IV. DEEM-FCIDTM Program and Consumption Information

Cyantraniliprole chronic dietary exposure assessment was conducted using the DEEMFCID, Version 3.16, which incorporates 2003-2008 consumption data from USDA’s 

NHANES/WWEIA. The data are based on the reported consumption of more than 

20,000 individuals over two non-consecutive survey days. Foods “as consumed” (e.g., 

apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit -

cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly 

available recipe translation files developed jointly by USDA/ARS and EPA. For chronic 

exposure assessment, consumption data are averaged for the entire U.S. population and 

within population subgroups. However, for acute exposure assessment, consumption 

data are retained as individual consumption events. Based on analysis of the 2003-2008 

WWEIA consumption data, which took into account dietary patterns and survey 

respondents, HED concluded that it is most appropriate to report risk for the following 

population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, 

children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 

years old.
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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For chronic dietary exposure assessment, an estimate of the residue level in each food or 

food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied 

by the average daily consumption estimate for that food/food form to produce a residue 

intake estimate. The resulting residue intake estimate for each food/food form is summed 

with the residue intake estimates for all other food/food forms on the commodity residue 

list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg 

body weight/day and as a percent of the cPAD. This procedure is performed for each 

population subgroup.

V. Toxicological Information

No acute hazard, attributable to a single dose, was identified; therefore, an acute dietary 

endpoint was not selected for quantitative risk assessment.

Based on the weight of evidence of the available scientific data, and in accordance with 

EPA’s Final Guidelines for Carcinogen Risk Assessment (March 2005), 

cyanantraniliprole may be classified as “Not Likely to Be Carcinogenic to Humans.”

The toxicity endpoints pertinent for human risk assessment are summarized in Table 3.

Table 3. Summary of Toxicological Doses and Endpoints for cyantraniliprole for Use in Dietary 

Human Health Risk Assessments.

Exposure/ 

Scenario

Point of 

Departure

Uncertainty

/FQPA 

Safety 

Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological Effects

Acute Dietary 

(General 

Population, 

including Infants 

and Children and 

Females 13-49 

years of age)

No effect attributed to a single dose was identified in the toxicology database. 

Chronic Dietary 

(All Populations)

NOAEL = 1 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 

1x

c RfD = 0.01 

mg/kg/day

cPAD = 0.01

mg/kg/day

1-year oral study in dogs

LOAEL =6 mg/kg/day based on 

effects indicative of liver toxicity 

(increased liver weights and 

alkaline phosphatase activity, and 

significant decreases in albumin 

level.

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not likely to be Carcinogenic to Humans” based on weight of 

evidence of data: No treatment-related increase in tumors incidence was 

demonstrated in rat and mouse carcinogenicity studies. No mutagenic concern was 

reported in the mutagenicity studies.
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Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response 

data and used to mark the beginning of extrapolation to determine risk associated with lower 

environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest 

observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human 

(interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (c = chronic). RfD = 

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

concentration.

VI. Results/Discussion 

As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCID analyses estimate the dietary exposure of the U.S. 

population and various population subgroups. The results reported in Table 5 are for the 

general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-

12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

For this chronic assessment, the U.S. population and all population subgroups have risk 

estimates which are below the Agency’s level of concern. The highest exposure and risk 

estimates were for the ‘children 1-2 years’ population subgroup. This exposure for food 

and water was 0.005027 mg/kg/day, which utilized 50% of the cPAD. The results of the 

chronic dietary analyses (food plus drinking water) are reported in Table 4 below.

Table 4. Result of Chronic Dietary Exposure and Risk Estimates for Cyantraniliprole

Population 

Subgroup

cPAD, 

mg/kg/day

Chronic Estimates (Food and Drinking Water)

Exposure, mg/kg/day Risk, % cPAD

U.S. Population 0.01 0.002223 22

All infants 0.004378 44

Children 1-2 yrs 0.005027 50

Children 3-5 yrs 0.003738 37

Children 6-12 yrs 0.002205 22

Youth 13-19 yrs 0.001484 15

Adults 20-49 yrs 0.001977 20

Adults 50+ yrs 0.002244 22

Females 13-49 yrs 0.002053 21

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

 

VII. Characterization of Inputs/Outputs

The dietary exposure and risk estimates are refined since they assume average residues 

for most crops and include empirical processing factors. Additional refinements may be 

implemented such as the incorporation of %CT data and inclusion of additional empirical 

processing factors. HED concludes that the chronic dietary exposure and risk estimates 

are not underestimated.
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VIII.Conclusions

A refined dietary (food and drinking water) exposure and risk assessment was performed 

for cyantraniliprole. The assumptions of this assessment were average residues for most 

crops, 100% CT, default DEEM 7.81 processing factors and empirical processing factors.

EDWCs from EFED were also included. The chronic dietary (food and drinking water) 

exposure estimates are below HED’s level of concern (<100% cPAD) for the general 

U.S. population and all population subgroups. Cyantraniliprole dietary (food and 

drinking water) risk is 22% of the cPAD for the U.S. population and 50% of the cPAD 

for ‘children 1-2 yrs old’, the most highly exposed population subgroup. 

IX. List of Attachments

1. Attachment 1. Chronic Food Plus Water Residue Input file.

2. Attachment 2. Chronic Results files: Food Plus Water

3. Attachment 3. Anticipated Residue Calculation for Risk Assessment
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Attachment 1. Chronic Food Plus Water Input File

Filename: C:\Documents and Settings\MNEGUSSI\My Documents\DEEM Version 

3.16\Cyantraniliprole\FirstSubmission\ChronicCYANTRANILIPROLEMEAN.R08

Chemical: Cyantraniliprole

RfD(Chronic): .01 mg/kg bw/day NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 01-16-2013/13:32:34 Program ver. 3.16, 03-08-d

Comment: Average Residues- Empirical PF-potato flakes, orange juice, apple juice, 

tomato (paste, puree, juice), tomato dried, cotton seed oil, citrus oil, dried plum

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0101050000 1AB Beet, garden, roots 0.020000 1.000 1.000 

0101050001 1AB Beet, garden, roots-babyfood 0.020000 1.000 1.000 

0101052000 1A Beet, sugar 0.020000 1.000 1.000 

0101052001 1A Beet, sugar-babyfood 0.020000 1.000 1.000 

0101053000 1A Beet, sugar, molasses 0.020000 1.000 1.000 

0101053001 1A Beet, sugar, molasses-babyfood 0.020000 1.000 1.000 

0101067000 1AB Burdock 0.020000 1.000 1.000 

0101078000 1AB Carrot 0.020000 1.000 1.000 

0101078001 1AB Carrot-babyfood 0.020000 1.000 1.000 

0101079000 1AB Carrot, juice 0.020000 1.000 1.000 

0101084000 1AB Celeriac 0.020000 1.000 1.000 

0101100000 1AB Chicory, roots 0.020000 1.000 1.000 

0101168000 1AB Ginseng, dried 0.020000 1.000 1.000 

0101190000 1AB Horseradish 0.020000 1.000 1.000 

0101250000 1AB Parsley, turnip rooted 0.020000 1.000 1.000 

0101251000 1AB Parsnip 0.020000 1.000 1.000 

0101251001 1AB Parsnip-babyfood 0.020000 1.000 1.000 

0101314000 1AB Radish, roots 0.020000 1.000 1.000 

0101316000 1AB Radish, Oriental, roots 0.020000 1.000 1.000 

0101327000 1AB Rutabaga 0.020000 1.000 1.000 

0101331000 1AB Salsify, roots 0.020000 1.000 1.000 

0101388000 1AB Turnip, roots 0.020000 1.000 1.000 

0103015000 1CD Arrowroot, flour 0.024000 1.000 1.000 DP# 40

 Full comment: DP# 407963

0103015001 1CD Arrowroot, flour-babyfood 0.024000 1.000 1.000 

0103017000 1CD Artichoke, Jerusalem 0.024000 1.000 1.000 

0103082000 1CD Cassava 0.024000 1.000 1.000 

0103082001 1CD Cassava-babyfood 0.024000 1.000 1.000 

0103139000 1CD Dasheen, corm 0.024000 1.000 1.000 

0103166000 1CD Ginger 0.024000 1.000 1.000 

0103166001 1CD Ginger-babyfood 0.024000 1.000 1.000 

0103167000 1CD Ginger, dried 0.024000 1.000 1.000 

0103296000 1C Potato, chips 0.025000 1.000 1.000 

0103297000 1C Potato, dry (granules/ flakes) 0.025000 1.000 1.000 

0103297001 1C Potato, dry (granules/ flakes)-b 0.025000 1.000 1.000 

0103298000 1C Potato, flour 0.025000 1.000 1.000 

0103298001 1C Potato, flour-babyfood 0.025000 1.000 1.000 

0103299000 1C Potato, tuber, w/peel 0.024000 1.000 1.000 

0103299001 1C Potato, tuber, w/peel-babyfood 0.024000 1.000 1.000 

0103300000 1C Potato, tuber, w/o peel 0.024000 1.000 1.000 

0103300001 1C Potato, tuber, w/o peel-babyfood 0.024000 1.000 1.000 

0103366000 1CD Sweet potato 0.024000 1.000 1.000 

0103366001 1CD Sweet potato-babyfood 0.024000 1.000 1.000 

0103371000 1CD Tanier, corm 0.024000 1.000 1.000 

0103387000 1CD Turmeric 0.024000 1.000 1.000 

0103406000 1CD Yam, true 0.024000 1.000 1.000 

0103407000 1CD Yam bean 0.024000 1.000 1.000 

0301165000 3A Garlic, bulb 0.015000 1.000 1.000 

0301165001 3A Garlic, bulb-babyfood 0.015000 1.000 1.000 

0301237000 3A Onion, bulb 0.015000 1.000 1.000 

0301237001 3A Onion, bulb-babyfood 0.015000 1.000 1.000 
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________ 

Page 13 of 22

0301238000 3A Onion, bulb, dried 0.015000 9.000 1.000 

0301238001 3A Onion, bulb, dried-babyfood 0.015000 9.000 1.000 

0301338000 3A Shallot, bulb 0.015000 1.000 1.000 

0302103000 3B Chive, fresh leaves 1.602000 1.000 1.000 DP# 40

 Full comment: DP# 407963

0302198000 3B Leek 1.602000 1.000 1.000 

0302239000 3B Onion, green 1.602000 1.000 1.000 

0302338500 3B Shallot, fresh leaves 1.602000 1.000 1.000 

0401005000 4A Amaranth, leafy 6.243000 1.000 1.000 DP# 40

 Full comment: DP# 407963

0401018000 4A Arugula 6.243000 1.000 1.000 

0401104000 4A Chrysanthemum, garland 6.243000 1.000 1.000 

0401133000 4A Cress, garden 6.243000 1.000 1.000 

0401134000 4A Cress, upland 6.243000 1.000 1.000 

0401138000 4A Dandelion, leaves 6.243000 1.000 1.000 

0401150000 4A Endive 6.243000 1.000 1.000 

0401204000 4A Lettuce, head 0.955000 1.000 1.000 

0401205000 4A Lettuce, leaf 4.430000 1.000 1.000 

0401248000 4A Parsley, leaves 6.243000 1.000 1.000 

0401313000 4A Radicchio 0.955000 1.000 1.000 

0401355000 4A Spinach 6.243000 1.000 1.000 

0401355001 4A Spinach-babyfood 6.243000 1.000 1.000 

0402076000 4B Cardoon 2.783000 1.000 1.000 

0402085000 4B Celery 2.783000 1.000 1.000 

0402085001 4B Celery-babyfood 2.783000 1.000 1.000 

0402086000 4B Celery, juice 2.783000 1.000 1.000 

0402087000 4B Celtuce 2.783000 1.000 1.000 

0402152000 4B Fennel, Florence 2.783000 1.000 1.000 

0402322000 4B Rhubarb 2.783000 1.000 1.000 

0402367000 4B Swiss chard 2.783000 1.000 1.000 

0501061000 5A Broccoli 0.743000 1.000 1.000 DP# 40

 Full comment: DP# 407963

0501061001 5A Broccoli-babyfood 0.743000 1.000 1.000 

0501062000 5A Broccoli, Chinese 0.743000 1.000 1.000 

0501064000 5A Brussels sprouts 0.556000 1.000 1.000 

0501069000 5A Cabbage 0.556000 1.000 1.000 

0501071000 5A Cabbage, Chinese, napa 0.556000 1.000 1.000 

0501072000 5A Cabbage, Chinese, mustard 0.556000 1.000 1.000 

0501083000 5A Cauliflower 0.743000 1.000 1.000 

0501196000 5A Kohlrabi 0.556000 1.000 1.000 

0502063000 5B Broccoli raab 7.391000 1.000 1.000 

0502070000 5B Cabbage, Chinese, bok choy 7.391000 1.000 1.000 

0502117000 5B Collards 7.391000 1.000 1.000 

0502194000 5B Kale 7.391000 1.000 1.000 

0502229000 5B Mustard greens 7.391000 1.000 1.000 

0502318000 5B Rape greens 7.391000 1.000 1.000 

0502389000 5B Turnip, greens 7.391000 1.000 1.000 

0801374000 8A Tomatillo 0.239000 1.000 1.000 

0801375000 8A Tomato 0.239000 1.000 1.000 

0801375001 8A Tomato-babyfood 0.239000 1.000 1.000 

0801376000 8A Tomato, paste 0.185000 1.000 1.000 

0801376001 8A Tomato, paste-babyfood 0.185000 1.000 1.000 

0801377000 8A Tomato, puree 0.058000 1.000 1.000 

0801377001 8A Tomato, puree-babyfood 0.058000 1.000 1.000 

0801378000 8A Tomato, dried 0.864000 1.000 1.000 

0801378001 8A Tomato, dried-babyfood 0.864000 1.000 1.000 

0801379000 8A Tomato, juice 0.032000 1.000 1.000 

0801380000 8A Tomato, Tree 0.239000 1.000 1.000 

0802148000 8BC Eggplant 0.119000 1.000 1.000 DP# 40

 Full comment: DP# 407963

0802234000 8BC Okra 0.119000 1.000 1.000 

0802270000 8B Pepper, bell 0.119000 1.000 1.000 

0802270001 8B Pepper, bell-babyfood 0.119000 1.000 1.000 

0802271000 8B Pepper, bell, dried 0.119000 1.000 1.000 

0802271001 8B Pepper, bell, dried-babyfood 0.119000 1.000 1.000 

0802272000 8BC Pepper, nonbell 0.343000 1.000 1.000 
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________ 

Page 14 of 22

0802272001 8BC Pepper, nonbell-babyfood 0.343000 1.000 1.000 

0802273000 8BC Pepper, nonbell, dried 0.343000 1.000 1.000 

0901075000 9A Cantaloupe 0.110000 1.000 1.000 

0901187000 9A Honeydew melon 0.110000 1.000 1.000 

0901399000 9A Watermelon 0.110000 1.000 1.000 

0901400000 9A Watermelon, juice 0.110000 1.000 1.000 

0902021000 9B Balsam pear 0.057000 1.000 1.000 DP# 40

 Full comment: DP# 407963

0902088000 9B Chayote, fruit 0.061000 1.000 1.000 

0902102000 9B Chinese waxgourd 0.057000 1.000 1.000 

0902135000 9B Cucumber 0.057000 1.000 1.000 

0902308000 9B Pumpkin 0.061000 1.000 1.000 

0902309000 9B Pumpkin, seed 0.061000 1.000 1.000 

0902356000 9B Squash, summer 0.061000 1.000 1.000 

0902356001 9B Squash, summer-babyfood 0.061000 1.000 1.000 

0902357000 9B Squash, winter 0.061000 1.000 1.000 

0902357001 9B Squash, winter-babyfood 0.061000 1.000 1.000 

1001106000 10A Citron 0.209000 1.000 1.000 DP# 40

 Full comment: DP# 407963

1001107000 10A Citrus hybrids 0.209000 1.000 1.000 

1001108000 10A Citrus, oil 1.371000 1.000 1.000 

1001240000 10A Orange 0.209000 1.000 1.000 

1001241000 10A Orange, juice 0.027000 1.000 1.000 

1001241001 10A Orange, juice-babyfood 0.027000 1.000 1.000 

1001242000 10A Orange, peel 0.473000 1.000 1.000 

1001369000 10A Tangerine 0.209000 1.000 1.000 

1001370000 10A Tangerine, juice 0.209000 2.300 1.000 

1002197000 10B Kumquat 0.209000 1.000 1.000 

1002199000 10B Lemon 0.198000 1.000 1.000 

1002200000 10B Lemon, juice 0.198000 2.000 1.000 

1002200001 10B Lemon, juice-babyfood 0.198000 2.000 1.000 

1002201000 10B Lemon, peel 0.423000 1.000 1.000 

1002206000 10B Lime 0.198000 1.000 1.000 

1002207000 10B Lime, juice 0.198000 2.000 1.000 

1002207001 10B Lime, juice-babyfood 0.198000 2.000 1.000 

1003180000 10C Grapefruit 0.157000 1.000 1.000 

1003181000 10C Grapefruit, juice 0.157000 2.100 1.000 

1003307000 10C Pummelo 0.157000 1.000 1.000 

1100007000 11 Apple, fruit with peel 0.168000 1.000 1.000 

1100008000 11 Apple, peeled fruit 0.168000 1.000 1.000 

1100008001 11 Apple, peeled fruit-babyfood 0.168000 1.000 1.000 

1100009000 11 Apple, dried 0.168000 8.000 1.000 DP# 40

 Full comment: DP# 407963

1100009001 11 Apple, dried-babyfood 0.168000 8.000 1.000 

1100010000 11 Apple, juice 0.064000 1.000 1.000 

1100010001 11 Apple, juice-babyfood 0.064000 1.000 1.000 

1100011000 11 Apple, sauce 0.585000 1.000 1.000 

1100011001 11 Apple, sauce-babyfood 0.585000 1.000 1.000 

1100129000 11 Crabapple 0.168000 1.000 1.000 

1100173500 11 Goji berry 0.239000 1.000 1.000 

1100210000 11 Loquat 0.278000 1.000 1.000 

1100266000 11 Pear 0.278000 1.000 1.000 

1100266001 11 Pear-babyfood 0.278000 1.000 1.000 

1100267000 11 Pear, dried 0.278000 6.250 1.000 

1100268000 11 Pear, juice 0.278000 1.000 1.000 

1100268001 11 Pear, juice-babyfood 0.278000 1.000 1.000 

1100310000 11 Quince 0.278000 1.000 1.000 

1201090000 12A Cherry 1.179000 1.000 1.000 

1201090001 12A Cherry-babyfood 1.179000 1.000 1.000 

1201091000 12A Cherry, juice 1.179000 1.500 1.000 

1201091001 12A Cherry, juice-babyfood 1.179000 1.500 1.000 

1202012000 12B Apricot 0.386000 1.000 1.000 DP# 40

 Full comment: DP# 407963

1202012001 12B Apricot-babyfood 0.386000 1.000 1.000 

1202013000 12B Apricot, dried 0.386000 6.000 1.000 

1202014000 12B Apricot, juice 0.386000 1.000 1.000 
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________ 

Page 15 of 22

1202014001 12B Apricot, juice-babyfood 0.386000 1.000 1.000 

1202230000 12B Nectarine 0.386000 1.000 1.000 

1202260000 12B Peach 0.386000 1.000 1.000 

1202260001 12B Peach-babyfood 0.386000 1.000 1.000 

1202261000 12B Peach, dried 0.386000 7.000 1.000 

1202261001 12B Peach, dried-babyfood 0.386000 7.000 1.000 

1202262000 12B Peach, juice 0.386000 1.000 1.000 

1202262001 12B Peach, juice-babyfood 0.386000 1.000 1.000 

1203285000 12C Plum 0.104000 1.000 1.000 

1203285001 12C Plum-babyfood 0.104000 1.000 1.000 

1203286000 12C Plum, prune, fresh 0.104000 1.000 1.000 

1203286001 12C Plum, prune, fresh-babyfood 0.104000 1.000 1.000 

1203287000 12C Plum, prune, dried 0.170000 1.000 1.000 

1203287001 12C Plum, prune, dried-babyfood 0.170000 1.000 1.000 

1203288000 12C Plum, prune, juice 0.104000 1.400 1.000 

1203288001 12C Plum, prune, juice-babyfood 0.104000 1.400 1.000 

1302057000 13B Blueberry 0.888000 1.000 1.000 DP# 40

 Full comment: DP# 407963

1302057001 13B Blueberry-babyfood 0.888000 1.000 1.000 

1302136000 13B Currant 0.888000 1.000 1.000 

1302137000 13B Currant, dried 0.888000 1.000 1.000 

1302149000 13B Elderberry 0.888000 1.000 1.000 

1302174000 13B Gooseberry 0.888000 1.000 1.000 

1302191000 13B Huckleberry 0.888000 1.000 1.000 

1400003000 14 Almond 0.013000 1.000 1.000 DP# 40

 Full comment: DP# 407963

1400003001 14 Almond-babyfood 0.013000 1.000 1.000 

1400004000 14 Almond, oil 0.013000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.013000 1.000 1.000 

1400059000 14 Brazil nut 0.010000 1.000 1.000 

1400068000 14 Butternut 0.010000 1.000 1.000 

1400081000 14 Cashew 0.010000 1.000 1.000 

1400092000 14 Chestnut 0.013000 1.000 1.000 

1400155000 14 Hazelnut 0.010000 1.000 1.000 

1400156000 14 Hazelnut, oil 0.010000 1.000 1.000 

1400185000 14 Hickory nut 0.010000 1.000 1.000 

1400213000 14 Macadamia nut 0.010000 1.000 1.000 

1400269000 14 Pecan 0.010000 1.000 1.000 

1400278000 14 Pine nut 0.010000 1.000 1.000 

1400282000 14 Pistachio 0.013000 1.000 1.000 

1400391000 14 Walnut 0.010000 1.000 1.000 

2001163000 20A Flax seed, oil 0.212000 1.000 1.000 

2001319000 20A Rapeseed, oil 0.157000 1.000 1.000 

2001319001 20A Rapeseed, oil-babyfood 0.157000 1.000 1.000 

2001336000 20A Sesame, seed 0.157000 1.000 1.000 

2001336001 20A Sesame, seed-babyfood 0.157000 1.000 1.000 

2001337000 20A Sesame, oil 0.157000 1.000 1.000 

2001337001 20A Sesame, oil-babyfood 0.157000 1.000 1.000 

2002330000 20B Safflower, oil 0.100000 1.000 1.000 

2002330001 20B Safflower, oil-babyfood 0.100000 1.000 1.000 

2002364000 20B Sunflower, seed 0.100000 1.000 1.000 DP# 40

 Full comment: DP# 407963

2002365000 20B Sunflower, oil 0.100000 1.000 1.000 

2002365001 20B Sunflower, oil-babyfood 0.100000 1.000 1.000 

2003114001 20C Coconut, oil-babyfood 0.212000 1.000 1.000 DP# 40

 Full comment: DP# 407963

2003128000 20C Cottonseed, oil 0.024000 1.000 1.000 

2003128001 20C Cottonseed, oil-babyfood 0.024000 1.000 1.000 

3100044000 31 Beef, meat 0.010000 1.000 1.000 

3100044001 31 Beef, meat-babyfood 0.010000 1.000 1.000 

3100045000 31 Beef, meat, dried 0.010000 1.920 1.000 

3100046000 31 Beef, meat byproducts 0.020000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.020000 1.000 1.000 

3100047000 31 Beef, fat 0.010000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.010000 1.000 1.000 

3100048000 31 Beef, kidney 0.010000 1.000 1.000 
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________ 

Page 16 of 22

3100049000 31 Beef, liver 0.020000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 0.020000 1.000 1.000 

3200169000 32 Goat, meat 0.010000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.020000 1.000 1.000 

3200171000 32 Goat, fat 0.010000 1.000 1.000 

3200172000 32 Goat, kidney 0.010000 1.000 1.000 

3200173000 32 Goat, liver 0.020000 1.000 1.000 

3300189000 33 Horse, meat 0.010000 1.000 1.000 

3500339000 35 Sheep, meat 0.010000 1.000 1.000 

3500339001 35 Sheep, meat-babyfood 0.010000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.020000 1.000 1.000 

3500341000 35 Sheep, fat 0.010000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.010000 1.000 1.000 

3500342000 35 Sheep, kidney 0.010000 1.000 1.000 

3500343000 35 Sheep, liver 0.020000 1.000 1.000 

3600222000 36 Milk, fat 0.010000 1.000 1.000 

3600222001 36 Milk, fat-baby food/infant formu 0.010000 1.000 1.000 

3600223000 36 Milk, nonfat solids 0.010000 1.000 1.000 

3600223001 36 Milk, nonfat solids-baby food/in 0.010000 1.000 1.000 

3600224000 36 Milk, water 0.010000 1.000 1.000 

3600224001 36 Milk, water-babyfood/infant form 0.010000 1.000 1.000 

3600225001 36 Milk, sugar (lactose)-baby food/ 0.010000 1.000 1.000 

3800221000 38 Meat, game 0.010000 1.000 1.000 

3900312000 39 Rabbit, meat 0.010000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.024450 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.024450 1.000 1.000 
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________ 

Page 17 of 22

Attachment 2. Chronic Food Plus Water Output File

U.S. EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for CYANTRANILIPROLE NHANES 2003-2008 2-day

Residue file name: C:\Documents and Settings\MNEGUSSI\My Documents\DEEM Version 

3.16\Cyantraniliprole\FirstSubmission\ChronicCYANTRANILIPROLEMEAN.R08

 Adjustment factor #2 NOT used.

Analysis Date 01-16-2013/13:33:40 Residue file dated: 01-16-2013/13:32:34

Reference dose (RfD, Chronic) = .01 mg/kg bw/day

COMMENT 1: Average Residues- Empirical PF-potato flakes, orange juice, apple juice, 

tomato (paste, puree, juice), tomato dried, cotton seed oil, citrus oil, dried plum

===============================================================================

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.002223 22.2%

Hispanic 0.002017 20.2%

Non-Hisp-White 0.002208 22.1%

Non-Hisp-Black 0.002254 22.5%

Non-Hisp-Other 0.002892 28.9%

Nursing Infants 0.002597 26.0%

Non-Nursing Infants 0.005173 51.7%

Female 13+ PREG 0.001979 19.8%

Children 1-6 0.004106 41.1%

Children 7-12 0.002031 20.3%

Male 13-19 0.001419 14.2%

Female 13-19/NP 0.001553 15.5%

Male 20+ 0.001866 18.7%

Female 20+/NP 0.002296 23.0%

Seniors 55+ 0.002225 22.2%

All Infants 0.004378 43.8%

Female 13-50 0.002058 20.6%

Children 1-2 0.005027 50.3%

Children 3-5 0.003738 37.4%

Children 6-12 0.002206 22.1%

Youth 13-19 0.001484 14.8%

Adults 20-49 0.001977 19.8%

Adults 50-99 0.002244 22.4%

Female 13-49 0.002053 20.5%
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________ 

Page 18 of 22

Attachment 3. Anticipated Residues for Risk Assessment.

DP# D407961, S. Funk, 01/25/2013

There are livestock feedstuffs associated with the proposed uses of cyantraniliprole, and 

the following ones are considered important and represent maximum dietary burdens: 

almond hulls, cotton gin byproducts, cotton meal, field corn grain (rotation), grass hay 

(rotation), potato culls, soybean hay (rotation), and sunflower meal. As a result, the 

estimated dietary burdens of cyantraniliprole to livestock, as presented in Table 1, are 

conservative. The estimated dietary burdens are 0.37 ppm for beef cattle, 0.41 ppm for 

dairy cattle, 0.01 ppm for poultry, and 0.011 ppm for swine. 

Table 1. Calculation of Dietary Burdens of Cyantraniliprole Residues to Livestock.

Feedstuff Type1 % Dry 

Matter2

% Diet2 Expected Residue Dietary 

Contribution 

(ppm) 3

Value used ppm

Beef Cattle: 15% R, 80% CC, 5% PC

Cotton, gin byproducts R 90 5 Median 3.15 0.175

Grass, hay (rotation) R 90 10 HAFT 0.23 0.026

Potato, culls CC 20 30 HAFT 0.11 0.165

Corn, field, grain 

(rotation)

CC 88 50 Median <0.01 0.005

Cotton, meal PC 89 5 PF x Median 0.016 0.000

TOTAL BURDEN -- -- 100 -- -- 0.37

Dairy Cattle: 45% R, 45% CC, 10% PC

Almond, hulls R 90 10 Median 1.55/ 0.172

Soybean, hay (rotation) R 89 20 HAFT 0.63 0.142

Grass, hay (rotation) R 90 15 HAFT 0.23 0.038

Potato, culls CC 20 10 HAFT 0.11 0.055

Corn, field, grain 

(rotation)

CC 88 35 Median <0.01 0.004

Cotton, meal PC 89 10 PF x Median 0.016 0.0018

TOTAL BURDEN -- -- 100 -- -- 0.41

Poultry: 75% CC, 25% PC

Corn, field, grain 

(rotation)

CC 88 75 Median <0.01 0.007

Cotton, meal PC 89 20 PF x Median 0.016 0.003

Sunflower, meal PC 92 5 PF x Median 0.007 0.000

TOTAL BURDEN -- -- 100 -- 0.01

Swine: 85% CC, 15% PC

Corn, field, grain 

(rotation)

CC 88 85 Median <0.01 0.0085

Cotton, meal PC 89 15 PF x Median 0.016 0.0024

TOTAL BURDEN -- -- 100 -- 0.011
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________ 

Page 19 of 22

1 R: Roughage; CC: Carbohydrate concentrate; PC: Protein concentrate.

2 OCSPP 860.1000 Table 1 Feedstuffs (June 2008). 

3 Contribution = ([expected residue /% DM] X % diet) for beef and dairy cattle; contribution = ([expected 

residue] X % diet) for swine and poultry.

Expected secondary residues in meat and milk

The data indicate that quantifiable residues of cyantraniliprole occur in all cattle matrices 

(except in muscle at the lowest 3 ppm dose level) at all dosing levels. Quantifiable 

residues were also detected for some of the metabolites. Transfer factors for 

cyantraniliprole and metabolites were calculated for each matrix from the maximum 

residues of cyantraniliprole and its metabolites observed at the dose level closest to the 

RBDB in the dairy cattle feeding study. The maximum and (mean) residues and 

calculated transfer factors are presented in Tables 2 and 3. 

Table 2. Maximum (Mean) Residues of Cyantraniliprole in Cattle Commodities.

Cattle 

Matrix

3.0 ppm

Cyan. 

(MW=473.7)

IN-J9Z38 

(MW=491.7)

IN-MLA84 

(MW=441.7)

IN-MYX98 

(MW=489.7)

IN-N7B69 

(MW=489.7)

Total 

Residues

Milk 0.030 0.01 0.01 0.01 0.028 0.088

Muscle 0.011

(<0.01)

0.01 0.01 0.01 0.01 0.051

Liver 0.066

(0.054)

0.01 0.043

(0.032)

0.01 0.01

(<0.01)

0.139

Kidney 0.031

(0.023)

0.01 0.011

(<0.01)

0.01 0.015

(0.012)

0.077

Fat10.015

(0.014)

0.012

(0.01)

0.01 0.01 0.01 0.057

1

Includes omental, perirenal, and subcutaneous fat.

Table 3. Maximum Anticipated Levels of Cyantraniliprole and Metabloites in Livestock 

Commodities Following Dosing at 1x the Dietary Burden.

Commodity

Transfer factors1 Estimated Dietary 

Burden2

Anticipated

Residue

Recommended 

Anticipated 

Residue3

Milk 0.0293 0.41 0.0120 0.01

Muscle 0.017 0.41 0.0070 0.01

Liver 0.0463 0.41 0.0190 0.02

Kidney 0.0257 0.41 0.0105 0.01

Fat 0.019 0.41 0.0078 0.01

1 Transfer factor calculated by dividing residue value by feeding level. For all tissues, the transfer factor 

was calculated using the maximum residue value observed at the specified feeding level.

2 The estimated dietary burden for dairy cattle was used since this was the highest among the ruminants. 

3 The highest expected anticipated residue for liver (0.02 ppm) was used for meatbyproducts of cattle, 

goat, horse, and sheep. 
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________ 

Page 20 of 22

Expected secondary residues in poultry eggs and tissues

Residues of cyantraniliprole in eggs and tissues were below 0.1 ppm in all samples at the 

lowest dose group of 3 ppm (300X dietary burden). The parent compound was the major 

residue. Residue levels were dose dependent. Eggs seemed to contain the highest 

amount of residues, followed by liver, fat with skin and muscle. Transfer factors for 

cyantraniliprole and metabolites were calculated for each matrix from the maximum 

residues of cyantraniliprole and its metabolites observed at the dose level closest to the 

RBDB in the laying hen feeding study. Metabolite residues were not converted to parent 

equivalents since the molecular weights were close to the parent. The maximum and 

(mean) residues and calculated transfer factors are presented in Tables 2 and 3. 

Table 4. Maximum Residues of Cyantraniliprole and Metabolites in Poultry.

Cattle Matrix 3.0 ppm

Cyan. 

(MW=473.7)

IN-J9Z38 

(MW=491.7)

IN-MLA84 

(MW=441.7)

IN-MYX98 

(MW=489.7)

IN-N7B69 

(MW=489.7)

Total 

Residues

Eggs 0.082 0.039 0.016 0.014 0.01 0.161

Muscle 0.01 0.01 0.01 0.01 0.01 0.05

Liver 0.017 0.01 0.015 0.023 0.01 0.075

Skin with fat 0.01 0.01 0.01 0.01 0.01 0.05

Table 5. Maximum Anticipated Levels of Cyantraniliprole and Metabolites in Poultry 

Commodities Following Dosing at 1x the Dietary Burden.

Commodity Transfer Factors1

Estimated Dietary 

Burden2

Anticipated

Residue

Recommended 

Tolerance

Eggs 0.0537 0.01 0.0005 None

Muscle 0.0167 0.01 0.0002 None

Liver 0.025 0.01 0.0002 None

Skin with fat 0.0167 0.01 0.0002 None

1 Transfer factor calculated by dividing residue value by feeding level. For all tissues, the transfer factor 

was calculated using the maximum residue value observed at the specified feeding level.

Based on the maximum anticipated residues, for risk assessment purposes, a tolerance 

level of 0.01 ppm is appropriate for residues of cyantraniliprole and its metabolite in milk 

and fat and at 0.02 ppm in liver and meat byproducts of cattle, goat, horse, and sheep. 

Tolerances for swine, eggs, and poultry are not needed based on the conclusion that there 

is no reasonable expectation of finite residues in poultry commodities (a §180.6(a)(3) 

situation). 
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

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860.1520 Processed Food and Feed

DP# D407961, S. Funk, 01/25/2013

Processing studies were reviewed for potato, spinach, tomatoes, oranges, apple, plums, 

and cottonseed. The data indicate that residues of cyantraniliprole and the metabolite 

(J9Z38) concentrated in sundried tomato, dry tomato pomace, orange oil, apple puree, dry 

apple pomace, applesauce, and dried plums. Metabolite IN-J9Z38 was included for 

dietary exposure analysis. Tolerance is recommended for citrus oil at 2.4 ppm. 

Estimation of Anticipated Residues for the Processed Commodities

Crop field trial data were used to estimate anticipated residues for the processed 

commodities. Average cyantraniliprole and the metabolite (IN-J9Z38) residues in the 

RAC were multiplied by relevant processing factors to obtain the estimate of residues in

the food as consumed. The result is combined and the total residue is used in the dietary 

assessment. 

Anticipated Residue (AR) = Cyantraniliprole (Average Residue) x Median Processing 

Factor (PF) + IN-J9Z38 (Average Residue) x Median PF.

Table 6: Summary of Processing Factors for Cyantraniliprole and IN-J9Z38.

RAC Processed Commodity Processing Factor (Median)

Cyantraniliprole IN-J9Z38

Potato 

Flakes 0.6 1

Potato waste 0.6 1

Peeled potato 0.6 1

Chips 0.6 1

Wet peel 0.9 4

Culls 1 1

Fries 0.6 1

Unpeeled boiled 0.6 1

Unpeeled microwaved 0.6 1

Spinach Leaves, cooked 0.16 95

Tomato 

Washed 0.18 1

Peeled 0.08 1

Sundried 3.5 2.7

Canned 0.08 1

Juice 0.09 1

Wet pomace 0.65 1.7

Dry pomace 1.8 3.5

Paste 0.60 4.2

Puree 0.19 1.3

Orange

Juice 0.08 1

Wet Pulp 0.20 1

Dry Pulp 0.38 1

Meal 0.39 1

Molasses 0.08 8.9
Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________ 

Page 22 of 22

Table 6: Summary of Processing Factors for Cyantraniliprole and IN-J9Z38.

RAC Processed Commodity Processing Factor (Median)

Cyantraniliprole IN-J9Z38

Marmalade 0.08 1

Oil 6.2 7.5

Canned 0.077 1

Apple

Washed 0.57 1

Puree 1.1 1

Canned 0.12 1

Frozen 0.95 1

Juice 0.32 1

Wet pomace 1 1

Dry pomace 2.6 1.1

Applesauce 1.4 35

Plum Dried 1.5 1.4

Cotton

seed

Oil

(solvent ext) 0.03 1

Refined oil

(solvent ext) 0.006 1.5

Meal

(solvent ext) 0.04 1

Hull 0.33 0.89

Oil

(cold press) 0.27 0.89