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

40 CFR: §180.XXX MRIDNo.: NA

FROM:

THROUGH:

TO: 

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

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)

Page 1 of22Cyantraniliprole

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

Page 2 of22Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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Page 3 of 22 

### 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 ge neral U.S.

population and 50 % of the cPAD for children (1

- 2 years old), the most highly exposed

subgroup.

I ntroduction

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 dos e is referred to as the populat ion

- 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 c PAD. 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 fruit s , stone fruit s , tree
nuts, and various vegetables.

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

compound. The residue s 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 . F unk, 01/25 /201 3 ) for names and structures.

The residue s of concern for drinking water assessment are the parent and numerous degradates. T he 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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Page 4 of 22 

### 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 relevan t 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 ; t hese values were included into the

assessment

. The EDWC was incorporated directly into the dietary assessment us ing the

1

- in

- 10 year annual mean of 24.45 μ g/L. A verage 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 a ssessment.

Meat, Milk, Poultry and Eggs :

Anticipated r esidues were calculated for milk fat, kidney, liver, meat, and meat

byproducts

. Based on th e dietary burden for livestock; li vestock tolerances are

re commended ( DP# D407961 , S. Funk, 01/25 /201 3 ). A l though 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 pr oducts )

.

For meat byproducts and liver the recommended value for risk assessment is 0.0 2 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, IN

MLA

- 84, IN

- MYX98, and IN

- J9Z38) should be included for risk assessment purposes.

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

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Page 5 of 22 

### Summary of Dieta ry Exposure Input Data

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

processing factors were used as appro priate

. T able 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 /201 3 ) 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 Factor s

Root and tuber vegetables

(Crop subgroup 1C) 0.15 0.1 10 0.02 4

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 0.02 7 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 0.9 5 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 Sund ried;

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 0.4Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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Page 6 of 22 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 Factor s

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 0.2 78

Stone Fruits Crop Group 12

C herry subgroup 12

- 12 A 6 .0 3.800 1.179

P each subgroup 12

- 12 B 1.5 0.960 0.386

P lum subgroup 12

- 12C 0.5 0.280 P = 0.104

M = 0.010

P lum, 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 0.02 3 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 0.6 1 0.157

Sunflower Seed 0.5 0.3 20 0.10



### Livestock Tolerances

/Anticipated ResiduesCyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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Page 7 of 22 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 Factor s

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 ) 0.0 1 0.0 2 2

1 AR for processed commodities AR = Cyantraniliprole (Average Residue) X Median Processing Factor (PF) + IN

J9 Z 38 (Average Residue) X Median PF ; Residue of concern for processed commodities are parent and the metabolite

(IN

- J9 Z 38).

2 AR for livestock commodities. Based on anticpated residues on liver a value of 0.0 2 ppm is used for meat byproducts

(c attle , goat, and sheep )

.



### III. Drinking Water Data

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

(DP 403747

, 

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

Water residues were incorporated in the DEEM

- FCID into the food categories “wate r, direct, all sources” and “water, indirect, all sources.” The EDWC for surface water w as

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 E FED Tier I screening

models. For surface water, the FIRST ( F QPA I ndex R eservoir S creening T ool)

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 maximu m 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 a nd 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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Page 8 of 22 Table 2 . Cyantraniliprole Estimated Drinking Water Concentrations (EDWC s) 1 for 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 DEEM

FCID, Version 3.16, which incorporates 2003

- 2008 consumption data from US DA’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

respondent s, 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

- 9 9

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

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Page 9 of 22 

### 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 expos ure. 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),

c yan antraniliprole may be cla ssified 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 Do ses 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 UF A = 10 x

UF H =10 x FQPA SF=

1 x 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: N o treatment

- related increase in tumors incidence was

demonstrated in rat and mouse carcinogenicity studies. N o mutagenic concern was

reported in the mutagenici ty studies.Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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Page 10 of 22 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. UF A = extrapolation from animal to human

(interspecies). UF H = 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/Discu ssion

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 ar e 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 0.005 0 27 mg/kg/day, which utilized 50 % of the cPAD

. The results of the

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

Table 4 . Result of Chronic Dietary Exposure and Risk Estimates for C y antraniliprole

Population

Subgroup cPAD,

mg/kg/day Chronic Estimates (Food and Drinking Water)

Exposure, mg/kg/day Risk, % cPAD

U.S. Population 0.01 0.002 2 23 22

All infants 0.00 4378 44

Children 1

- 2 yrs 0.005 027 50

Children 3

- 5 yrs 0.00 3738 37

Children 6

- 12 yrs 0.002 205 22

Youth 13

- 19 yrs 0.001 484 15

Adults 20

- 49 yrs 0.00 1977 20

Adults 50+ yrs 0.0022 44 22

Females 13

- 49 yrs 0.0020 53 2 1

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 a verage 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.Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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Page 11 of 22 

### VIII. Conclusions

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

for c y antraniliprole . The assumptions of th is 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. C y antraniliprole dietary (food and

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

for ‘children 1

- 2 yrs old’, the most highly exposed population subgroup.

IX. List of Attachme nts

1. Attachment 1. Chronic Food Plus W ater Residue Input file.

2. Attachment 2. Chronic Results file s : Food Plus Water

3. Attachment 3. Anticipated Residue Calculation for Risk AssessmentCyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

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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

- 2013/1 3:32:34 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

010 1052001 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

- b abyfood 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 0.0240 00 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

01031 66001 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 (g ranules/ 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 0.02 5000 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, c orm 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 1.000Cyantraniliprole 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

03022 39000 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 4 A 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 1.0 00 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, p uree

- 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 0.1190 00 1.000 1.000

0802271001 8B Pepper, bell, dried

- babyfood 0.119000 1.000 1.000

0802272000 8BC Pepper, nonbell 0.343000 1.000 1.000Cyantraniliprole 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

08022 73000 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 9 B 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, s ummer

- 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 0.4730 00 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

10021 99000 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 0.19 8000 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

110 0007000 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

1100129 000 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 0.2780 00 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

12010 90001 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 1 2B Apricot, juice 0.386000 1.000 1.000Cyantraniliprole 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 Plu m, 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 0.01000 0 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 2 0C 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 1.000Cyantraniliprole 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 1.00 0

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 fo rm 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 1.000Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

___________________________________________________________________________________

Page 17 of 22 

### Atta chment 2 . Chronic Food Plus W ater 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 \ Fir stSubmission \ 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

COMM ENT 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 Inf ants 0.005173 51.7%

Female 13+ PREG 0.001979 19.8%

Children 1

- 6 0.004106 41.1%

Children 7

- 12 0.002 031 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%

You th 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

. Ca lculation of Dietary Burdens of Cyantraniliprole Residues to Livestock.

Feedstuff Type 1 % Dry

Matter 2 % Diet 2 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

-- 0.011Cyantraniliprole 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 fact ors 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 an d

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) 0.1 39

Kidney 0.031

(0.023) 0.01 0.011

(<0.01) 0.01 0.015

(0.012) 0.0 7 7

Fat 1 0.015

(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 factors 1 Estimated Dietary

Burden 2 Anticipated

Residue Recommended

Anticipated

Residue 3

Milk 0.0 2 93 0.41 0.0 120 0.01

Muscle 0.0 17 0.41 0.00 70 0.01

Liver 0.0 4 6 3 0.41 0.01 90 0.0 2

Kidney 0.0 25 7 0.41 0.0 105 0.01

Fat 0.0 19 0.41 0.00 7 8 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 ( 0.0 2 ppm ) was used for meatbyproducts of cattle,

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

PC Code 090098

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Page 20 of 22 

### Expected secondary r esidues 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. T he maximum and

(mean) residues and calculated transfer fac tors 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 0.1 6 1

Muscle 0.01 0.01 0.01 0.01 0.01 0.05

Liver 0.017 0.01 0.015 0.023 0.01 0.0 75

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 Factors 1 Estimated Dietary

Burden 2 Anticipated

Residue Recommended

Tolerance

Eggs 0.05 3 7 0.01 

### 0.0005 None

Muscle 0.0 16 7 0.01 

### 0.000 2 None

Liver 0.02 5 0.01 

### 0.000 2 None

Skin with fat 0.0 16 7 0.01 

### 0.000 2 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 0.0 2 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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Page 21 of 22 

### 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 cyantrani li prole and the metabolite

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

apple pomace, applesauce , and dried plums. Metabolite IN

- J9Z38 was included f or 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 8.9Cyantraniliprole Dietary Exposure and Risk Assessment DP# 407963

PC Code 090098

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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