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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

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"1(**PRO"'i~v** OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
DP Barcode: 403747 PC Code: 090098 November21,2012 MEMORANDUM SUBJECT:

TO:

FROM:

THRU: Tier I Drinking Water Exposure Assessment for Cyantraniliprole in Support of New Chemical Registration onVarious Crops
Tom Harris, Risk Manager Reviewer MeredithLaws, Branch Chief Registration Division (7505P) Nancy Tsaur MeheretNeguisse Health Effects Division (7509P) Christopher M. Koper, Chemist 

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# NO\.EU~~l~ Environmental Risk BranchI Environmental Fate andEffects Division

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### 2 Ed Odenkirchen, Ph.D., Acting Branch**Sh~L** ·l**~** \ \

.**~** Sujatha Sankula, Ph.D., Lead Biologist

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### ~\ \:r-- Environmental Risk Branch I Environmental Fate and Effects Division EXECUTIVE SUMMARY Cyantraniliprole is under global review submittedjointlyby DuPont and Syngenta. The registrants are seeking U.S. registrations ona multitude ofcommodities, includingberries, brassicavegetables, bulb vegetables, canola, citrus, cotton, cucurbits, fruiting vegetables, leafy vegetables, ornamentals, pome fruit, potatoes, stone fruit, sunflower, tree nuts and turf. Application methods include foliar spray, drip irrigation, soil drench and seed treatment. Maximum single applicationrates range from 0.087 to 0.468 lbs. a.i./acre withmaximumyearly applicationrates ranging from 0.175 to 0.468 lbs. a.i./acre.

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2088322Cyantraniliprole is a new systemic, cross-spectrum insecticide belongingto the diamide class of chemistry, moving bothinthe xylem and phloem. The specific mode ofaction is through cyantraniliprole binding with insectryanodine receptors. This mode ofaction causes muscle contraction, whichleads to paralysis and ultimately death ofthe insect. Cyantraniliprole is identical to chlorantraniliprole exceptthe cyano for chloro-group substitution. This drinking water assessment was conducted onthe parent cyantraniliprole including numerous degradates. Itwas decided at the Residues ofConcern Knowledgebase Subcommittee (ROCKS) meeting to include the degradates IN-J9Z38, IN-NXX69, IN-QKV54, IN-RNU71, IN-JSE76, INJCZ38, IN-K5A78, IN-K5A77, IN-K5A79, and IN-PLT97 into the tolerance expression. In the absence oftoxicity 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. Additional information is described in the ROCKS decision memorandum D404411 dated 24 July 2012 (US EPA, 2012). The Estimated Drinking Water Concentrations (EDWCs) for use inthe humanhealthrisk assessment are based onthe maximumproposed application rates specified inthe product labels. Forreference, the productrate table canbe found in 

### Appendix 

### III. TierI screening models were employed for this assessment. For surface water, the FIRST (_EQPA Index Reservoir .S.creening Iool) Version1.1.1 model was used to estimate drinking water concentrations. For ground water, the SCI-GROWmodel (Screening Concentration in Ground Water Program Version 2.3 was used to predict the maximum acute and acute concentrations present in shallow ground water. Additional informationregardingthe exposure models canbe found on the U.S. EPA Water Model's website at (http://www.epa.gov/oppefedllmodels/water/). Based on FIRST and SCI-GROWmodeling, the surface and ground waterEDWCs for the parent cyantraniliprole for various uses are presented in Table 1.

2Table 1. Maximum Estimated Drinking Water Concentrations (EDWCs) resulting from applications ofCyantraniliprole for Various Uses Peak Day Annual Drinking Application Rate PCA Average Water Source Label Use Method (interval between Adjustment (acute) (chronic) (Model) applications) Factor 1 Concentration Concentration (IJ.g/L) (IJ.g/L) 352-lLT Various Aerial 3 app@ O.I33 a.i./acre 40.77 23.I I 352-ILO Crops (5 days) 352-IAN Citrus Chemigation I app@ 0.4 a.i.!acre 40.75 23.09 Vegetables (NA) Surface Water 352-ILI Canola Seed I app@ 0.4 a.i./acre I 40.75 23.09 (FIRST) Mustard Treatment (NA) 352-IAE Fly Control Bait Stations 5 app @ 0.087 a.i./acre 43.14 24.45 (7 days) 100-RUEN Potato Seed I app @ 0.468 a.i./acre 23.84 I3.5I IOO-RURI Treatment (NA) 352-ILT Various Aerial 3 app@ O.I33 a.i./acre



### --- 5.40 5.40 Ground Water 352-ILO Crops (5 days) (SCI-GROW) IOO-RUEN Potato Seed I app@ 0.468 a.i./acre



### --- 6.33 6.33 IOO-RURI Treatment (NA) Bold values denote maximum Estimated Drinking Water Concentrations (EDWCs) 1Percent Cropped Area (PCA) Adjustment Factor= I following updated PCA guidance document (20I2). NA =NotApplicable
For drinking water derived from surface water for the parent cyantraniliprole, the FIRST model estimatedthe acute and chronic (annual average) concentrations at 43.14 ug/L and 24.45 ug!L, respectively. For drinking water derived from groundwaterfor the parent cyantraniliprole, the SCI-GROW model estimatedthe ground water concentration at 6.33 ug!L. This concentration shouldbe used for the acute, chronic and cancer-chronic values, respectively.

Environmental Fate Summary Mobility Cyantraniliprole is soluble in water (14.2 mg/L at 20°C; MRID 48119901). The vaporpressure of 3.85 x 10" 17 mm Hg at 20°C(MRID 48122593) and Henry's Law constant of 1.7 x 10" 18 atm*m3 /mol at 20°C (MRID 48119907) indicate that cyantraniliprole is a non-volatile chemical. Batch equilibrium studies have been conducted with the same soils on cyantraniliprole and its degradates. Cyantraniliprole is characterized as being moderatelymobile (Koc 

### = 157 to 376 mL/goc; MRID 48120073) in the test soils (FAO Classification; USEPA, 2006). Cyantraniliprole degradates have measured Koc values ranging from 14 to 32,152 mL/g indicating that some degradates are more mobile thanthe parent and some are less mobile than the parent (Table2).

3Table2. FAO Mobility Classification ofCyantraniliprole and its Degradates Koc Range Mean Mobility Class Chemical ID Koc MRID (mL/goc) (mL/goc) Mobile IN-JSE76 14-65 30 48120067 IN-K5A79 24-85 46 48120072 IN-RNU71 104-181 146 48120088 ModeratelyMobile IN-JCZ38 124-482 239 48120066 DPX-HGW86* 157-376 241 48120073 Moderately Mobile- IN-K5A78 412-2545 1048 48120068 Slightly Mobile IN-PLT97 701-5029 2044 48120075 SlightlyMobile

- IN-J9Z38 4500-18526 8705 48120065 IN-K5A77 3707-25306 9611 48120069 HardlyMobile IN-QKV54 8571-32152 14481 48120086 

## *DPX-HGW86 represents the chemical ID for theparent cyantraniliprole.
In terrestrial field studies, cyantraniliprole dissipated with DT50s ranging from 3.4 to 44 days (Table 3). Seven degradates formed as cyantraniliprole degraded including IN-J9Z38, INJCZ38, IN-JSE76, IN-K5A77, IN-K5A78, IN-K5A79 and IN-PLT97. The majority ofresidues detected was confined to the uppermost soil layers (0-2 to 2-6 inches) with a small amount ofthe parent or degradates detected belowthe 12 inch soil layer, indicating a general lack ofdownward mobility orleaching underthe study conditions. The most common degradates formed were INJ9Z38**(~10%),** IN-JCZ38**(~8%),** IN-JSE76**(~10%),** and IN-K5A78**(~10%).** Aerobic soil metabolism studies have been conducted on most degradates. Table3 illustrates the DT50 profile.

Table3. Terrestrial Field Dissapation Half-Life Summaries Location DTso MRID Duration Plot**T_y~>_e (day~**  Bare Soil 10.2 48120055 CA (539 days) Cropped Lettuce 3.5 Bare Soil 9.7 48120054 WA (534 days) Cropped Potato 3.4 Bare Soil 44.0 48120056 MO (541 days) Cropped Alfalfa 6.0 48120053 NY (514 days) Bare Soil 21.6 48120058 TX (539 days) Bare Soil 16.7 48120057 CANADA (502 days) Bare Soil 13.5

4Bioaccumulationdata indicate that cyantraniliprole is not likelyto bioaccumulate with a BCF value less than 1in whole fish. In addition, non-extractableresidues made up a significant amount ofrecovered applied radioactivity, with maximum levels ranging from 12.7 to 28.83% in various fate studies. Sufficient extractionprocedures using appropriate solvents were utilized and adequate extraction efficiencies were demonstrated. 

### Degradation Considering abiotic degradation, cyantraniliprole's hydrolytic degradation appears to be pH dependent, with degradation increasing with increasing pH. This is evidentin the DT50 profile. The DT50 values decrease from 222 days (stable) at pH4 to 31 days at pH 7 to 0.86 days at pH 9 (T=25°C; MRID 48119905). Photodegradation appears to be a major degradation pathwayin aqueous and moist soil environments. The aqueous photolysis study shows aphototransformationhalf-life ofabout 7.9 hours or0.33 days (MRID 48119906). Soil photolysis studies were conducted with both a moist soil where soil moisture was maintained and an air-dried soil where the soil was allowed to airdry overtime. The moist-soil DT50 value was 12.5 days (MRID 48120082) whereas the compound was considered stable in the air-dried soil photolysis study since the extrapolatedhalflife was well beyond the duration ofthe study (MRID 48120046). Biodegradation is an effective dissipationpathwayfor cyantraniliprole, with anaerobic biotransformation occurring at a faster rate than aerobic biotransformation interrestrial and aquatic environments. Illustrating this point, aerobic system DT50 values ranged from 16.2 days in a siltyclay loam soil (pH 8.05) to 89.4 days in a sandy loam soil (pH 4.62) in an aerobic soil metabolism study conducted at 20°C (MRID 48120045). In addition, the DT50 values ranged from 3.9 days in a silt loam sediment-water system (pH 7.7) to 25.1 days in a loamy sand sediment-water system (pH 5.6) in an aerobic aquatic metabolism study conducted at 20°C (MRID 48120049).
In anaerobic systems, the DT50 value was 4.3 days in a sandy loam soil (pH 8.05) conducted in an anaerobic soil metabolism study conducted at 20°C (MRID 48120047). In addition, the DT50 values ranged from 2.4 days in a sandy loam sediment-water system (pH 6.9; MRID 48120071) to 12 days in a sandy sediment-water system (pH 6.6) in an anaerobic aquatic metabolism study conducted at 20°C (MRID 48120081). 

### It is importantto note, other than the degradate INJCZ38, all other aerobic soil metabolism degradation halflife values are significantlylongerthan the parent cyantraniliprole 

### (Table4).
Table 4. Aerobic Soil Metabolism Half-Life Summaries for Cyantraniliproleand its Degradates ChemicaiiD Soil Texture DTso (days! MRID Cyantraniliprole Gross-Umstadt Silt Loam 41.2 48120045 Sassafras Sandy Loam 89.4

Lleida Silty Clay Loam 16.2 5Gross-Umstadt Silt Loam 118 IN-J9Z38 Nambshiem Sandy Loam 77.1 48120060 Sassafras Loam 200

Lieida Silty Clay Loam 104 Tama Silty Clay Loam 179 Gross-Umstadt Silt Loam 11.6 IN-JCZ38 Nambshiem Sandy Loam 3.48 48120061 Sassafras Loam 10.1

Lieida Silty Clay Loam 4.81 Tama Silty Clay Loam 9.41 Gross-Umstadt Silt Loam 219 IN-JSE76 Nambshiem Sandy Loam 84.9 48120062 Sassafras Loam 336

Lleida Silty Clay Loam 157 Tama Silty Clay Loam 840 Gross-Umstadt Silt Loam 294 JN-K5A77 Nambshiem Sandy Loam 23.8 48120064 Sassafras Loam 340

Lieida Silty Clay Loam 25.9 Tama Silty Clay Loam 78.6 Gross-Umstadt Silt Loam 308 JN-K5A78 Nambshiem Sandy Loam 1055 48120063 Sassafras Loam 94

Lleida Silty Clay Loam 517 Tama Silty Clay Loam 241 Gross-Umstadt Loam 46 JN-K5A79 Nambshiem Loam 25 48120070 Sassafras Sandy Loam 107

Lleida Silty Clay 19 Tama Silty Clav 131 Gross-Umstadt Loam 1638 IN-PLT97 Nambshiem Sandy Loam 711 48120074 Sassafras Loam 1837

Lleida Silty Clay 439 Tama Silty Clav Loam 429 Gross-Umstadt Loam 1187 JN-QKV54 Nambshiem Sandy Loam 139 48120083 Sassafras Loamy Sand 462

Lleida Clay 58 Tama Silty Clay Loam 184 Gross-Umstadt Loam 107 JN-RNU71 Nambshiem Sandy Loam 42 48120087 Sassafras Loamy Sand 400

Lieida Clay 43 Tama Silty Clay Loam 28 Rate ofdegradation in aerobic soils at 20 degrees C and 40-60% MWHC except for IN-K5A79 which was studied at 19 degrees C (Sassafras) and 24 degrees C (all other soils) and 40-60% MWHC. 

### Water Resources Summary A. Surface Water: Cyantraniliprole may move from the treated field to surface waterthrough run-offwhich occurs shortly after application (i.e. rainfall events). Mobility andpersistence ofcyantraniliprole's 6degradates maybe ofconcern as Table 2 and Table 4 illustrates. The tier 1drinking water concentrations derived from surface water for the parent cyantraniliprole were estimated using the FIRSTmodel Version 1.1.1. Input values for the FIRSTmodel are reported in 

### Table 5. Model outputs are included in 

### Appendix I.



### Table 5: FIRST Input Parameters for Cyantraniliprole for Various Uses
Parameter: Input Value: Data Source/Rationale: 1 0.133 EPA Reg. No. 352-ILTand ILO Application Rate (lbs a.i./acre) 0.400 EPA Reg. No. 352-IAN 0.400 EPA Reg. No. 352-ILI 0.087 EPA Reg. No. 352-IAE 0.468 EPA Reg. No. 100-RUEN and RURI 3 EPA Reg. No. 352-ILTand ILO Maximum Number of I EPA Reg. No. 352-IAN Applications/Year I EPA Reg. No. 352-ILI 5 EPA Reg. No. 352-IAE I EPA Reg. No. 100-RUEN and RURI 5 EPA Reg. No. 352-ILTand ILO Application Interval (days) NA EPA Reg. No. 352-IAN NA EPA Reg. No. 352-ILI 7 EPA Reg. No. 352-IAE NA EPA Reg. No. 1 00-RUEN and RURI Percent CropArea (as decimal) 1.0 Represents mixed agriculture and nonagricultural uses Koc 14 Lowest Koc value among parent and degradates: MRID 48120067 (Table 2)

Aerobic Soil Metabolism Half-life 358 value represents the upper 90% confidence limit (days) on the mean value ofparent and degradate DT50 values (Table 4).

Is the pesticide wetted-in? No Chemical not known to be activated by water 16 Aerial App. (352-ILT and ILO) Spray Drift(%) 0 GranularApp. (all other labels- chemigation, fly baitand seed treatment) 0 EPA Reg. No. 352-ILTand ILO Incorporation Depth (inches) 0 EPA Reg. No. 352-IAN 0.125 (!/8") EPA Reg. No. 352-ILI 0 EPA Reg. No. 352-IAE 2 EPA Reg. No. 1 00-RUEN and RURI 7Solubility (ppm) 14.2 MRID48119901

Aerobic Aquatic Metabolism 589 TTRvalue (MRID 48120049) Half-life (days)
Photolysis Half-life (days) 88 TTRvalue (MRID 48119906)

1 Input Parameters were selected in accordance with the Guidance for Selecting Input Parameters (Version II)

dated February 28, 2002. NA =NotApplicable B. Groundwater
Due to the stability and mobility cyantraniliprole's degradates, some compounds may move from the treated field to groundwaterthrough leaching. Table 6 details the inputparameters for the screening level groundwatermodel, SCI-GROW, for the parent cyantraniliprole only. Model outputs are included inAppendix II.

Table6: SCI-GROW InputParameters for Cyantraniliprole
Parameter: Input Value: Data Source/Rationale 1 Application Rate (lbs a.i./acre) 0.133 EPA Reg. No. 352-ILT and ILO 0.468 EPA Reg. No. I00-RUEN and RURI

Maximum Numberof 3 EPA Reg. No. 352-ILTand ILO Applications/Year 1 EPA Reg. No. 100-RUEN and RURI

Aerobic Soil Metabolism 112.5 Since there were greaterthan 4 halflife Half-life (days) values, used the median halflife value ofall parent and degradate aerobic soil metabolism data (Table 4).

Koc 14 Since there was morethan athree-fold variation among values, used lowest Koc value among parent and degradates: MRID 48120067 (Table 2)

1 Input Parameters were selected in accordance with the Guidance for Selecting Input Parameters (Version II)

dated February 28, 2002 8A. Monitoring: 

### Being a newchemical, currentlythere is no monitoring data onthe concentrations ofthe parent cyantraniliprole in surface or groundwater.



### REFERENCES USEPA. 

### 2006. Standardized Soil Mobility Classification Guidance. U.S. Environmental Protection Agency, Office ofPrevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Environmental Fate and Effects Division, Memorandum. April 21, 2006. USEPA. 

### 2012. Cyantraniliprole: Report ofthe Residues ofConcern Knowledgebase Subcommittee (ROCKS). D404411 dated 24 July 2012. U.S. Environmental Protection Agency. Washington, DC.

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### Appendix I: Representative FIRST Outputfor Cyantraniliprole Cyantraniliprole- Fly Control Use- Bait Stations RUN No. 1 FOR Cyantraniliprole ON Fly Control * INPUT VALUES *
RATE (#/AC)

ONE(MULT) No.APPS & INTERVAL SOIL SOLUBIL APPL TYPE %CROPPED INCORP Koc (PPM ) (%DRIFT) AREA (IN) 0.087( 0.423) 5 7 14.0 14.2 GRANUL( 0.0) 100.0 0.0

FIELD AND RESERVOIR HALFLIFE VALUES (DAYS) METABOLIC DAYS UNTIL

(FIELD) RAIN/RUNOFF 358.00 2 HYDROLYSIS (RESERVOIR) 0.00 PHOTOLYSIS (RES. -EFF) METABOLIC (RESER.) 88.00-10912.00 589.00 COMBINED (RESER.)

558.84 UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.1 MAR 26, 2008 PEAK DAY (ACUTE) CONCENTRATION 43.14 ANNUAL AVERAGE (CHRONIC) CONCENTRATION 24.45 

### Appendix II: Representative SCI-GROW Outputfor Cyantraniliprole Cyantraniliprole- Potato Seed Treatment SciGrow version 2.3 chemical:Cyantraniliprole time is 11/19/2012 5:17:34 Application Number of Total Use Koc Soil Aerobic rate (lb/acre) applications (lb/acre/yr) (mllg) metabolism (days) 0.468 1.0 0.468 1.40E+01 112.5 groundwater screening cond (ppb) = 6.33

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### Appendix III: Product Rate Table
1\\tximum Single 1\\tximum 1\\tximum AwJication AwJication Nurmerof AwJication Rate EPAFile Al AwJication lnterv.d: Rate: AwJications: perYear: PRODLCT: Syntlol: (%)**~thod:** (dlys) (lbs. a.i.!acre) (year) (lbs a.iJacre) Aerial DuPontTMBeneviaTM 352-ILT 10.26 Gound 5. 7 0.133 3 0.400 Chemigation DuPontTME'(jrelTM 352-IW 10.20 Aerial 5. 7 0.133 3 0.400 Gound DuPontn1VerirmrkTM 352-IAN 18.66 Gound 5. 7 0.400 I 0.400 Chemigation DuPontTMDemncot®Z-103 352-IU 50.00 Seed Treatzrent NA 0.400 I 0.400
DuPontT"HGW86 352-IAE 0.50 Fly Control 7 0.087 5 0.440 Bait DuPontTMHGW86 SC 352-IAI 18.66 Insect Control NA 0.400 I 0.400
DuPontTMHGW86T&O 352-IAL 18.66 Cround NA 0.313 I 0.313
DuPontTMHGW86G-I&N 352-IAG 18.66 Gound Chemigation NA 0.233 I 0.233
A 169001BCP 100-RUER 20.00 Foliar(A.G) 5.7 0.0875 2 0.175 Chemigation NA 0.175 I 0.175 Mainspring Insecticide 100-RUEE 20.00 Gound Cbemigation 14 0.131 2 0.262
A169018Residential 100-RUEG 20.00 Gound 7 0.131 2 0.262
A169018Turf 100-RUEU 20.00 Broadcast 30.45 0.1325 2 0.265 (Gound) A.I7960A ST 100-RUEN 48.80 Seed Treatzrent NA 0.468 I 0.468
AI7960BST 100-RURI 48.80 Seed Treatzrent NA 0.468 I 0.468 Uibel 352-IIAis for DuPontTM CyazypyrTMfechnical (96.7%)

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