Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### UNITED STATES ENVIRONMENTAL PROTECTI ON AGENCY WASHI NGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### MEMORANDUM Date: 15 - October - 20 1 1 Subject: **Spirodiclofen.** Dietary Risk Assessment in Support of the Requested use on Sugar Apple, Cherimoya, Atemoya, Custard Apple, Ilama, Soursop, Biriba, Lychee, L ongan, Spanish Lime, Rambutan, Pulasan, Guava, Feijoa, Jaboticaba, Wax Jambu, Starfruit, Passionfruit, Persimmon, and Acerola . **PC Code:** 124871 **DP Barcode:** D 387338 **Decision No.:** 443557 **Registration No. :**  264 - 831 **Petition No.:** 0E7820 **Regulatory Action:** Section 3 **Risk Assessment Type:** dietary **Case No.:** 7443 **T XR No.:**  not applicable **CAS No.:** 148477 - 71 - 8 **MRID No. :**  none **40 CFR:** 180.608 

### From : Tom Bloem , Chemist

Risk Assessment Branch 1 /Health Effects Division (RAB 1 /HED; 7509P) Through: Kristin Rury , Biologist, RAB 3 /HED

Julie Van Alstine , Environmental Health Scientist , RAB 1 /HED Dietary Exposure Science Advisory Council (DESAC) George F. Kramer, Ph.D., Senior Chemist HED/RAB1 (7509P) To: Jennifer Tyler , Chemist

HED/RAB1 (7509P) **Executive Summary** In support of the proposed Section 3 Registration for application of spirodiclofen to several tropical fruits , chronic and cancer dietary risk assessments were conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM - FCID  , ver. 2.03) which incorporates consumption data from United States Department of Agriculture (USDA) Continuing Survey

of Food Intake by

Individuals ( CSFII ; 1994 - 1996 and 1998). An acute dietary risk assessment was not conducted as an endpoint attributable to a single dose was not identified . The chronic and cancer analyses assumed the following: **(1)** average field trial residues (food and feed commodities) ; **(2)** experimentally determined processing factors for citrus fruit, pome fruit,Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### and grape (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); **(3)** B iological and Economic Analysis Division (B EAD ) new use percent crop treated estimates for hops (92%) and blueberry (2%) , and screening level usage analysis (SLUA) data when available; **(4)** livestock residues which incorporated average field trial residues for determination of the livestock dietary

burdens; and **(5 )**  drinking water estimates derived from the Pesticide Root Zone Model/Exposure Analy sis Modeling Sy stem ( PRZM/EXAMS ; citrus application scenario; 1 x 0.31 lb ai/acre ; citrus yielded the highest chronic/cancer drinking water estimates ). The r esulting chronic risk estimates (food and water) were ≤3. 2 % the chronic population - adjusted dose ( cPAD ) and are not of concern to HED ( children 1 - 2 years old were the most highly exposed population). The cancer risk estimate (food and water) for the U.S. population was 3 x 10 - 6 

### . The major contributors to the cancer anal ys is were hops (44 % ; assumes 100% transfer of residues from hops to beer; spirodiclofen Log KOW 

### = 5.83 ) and water ( 21 % ; 87% of the basin cropped and 100% crop treated at the maximum labeled rate). **I. Introduction**  Dietary risk assessment incorporates both exposure and toxicity of a 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 i s 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 acute and non - cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generall y concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and 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). The most recent dietary risk assessment for spirodiclofen can be found in D3 71644 (T. Bloem, 2 8 - Jul - 20 10 ). **II. Residue Information**  Residues of Concern in Plan ts and Livestock: Based on the results of the citrus, grape, and apple metabolism studies ( Risk Assessment Document: D285047, M Clock- Rust et al ., 22 - Jun - 2005 ); the apple, grape, and orange processing studies (D341847, T. Bloem, 22 - Jun - 2005; D359773, T. Bloem, 24 - Jun - 2009; D390192, T. Bloem, 20 - Jun - 2011); and previous conclusions relating to the residues of concern in hops (D346710, M. Sahafeyan, 3 - Jan - 2008); HED concludes that the residues of concern in the currently- registered/proposed crops are as foll ows (see Table 1 for a summary): pome fruit , tree nut , and hops - the residue of concern for risk assessment and tolerance enforcement is spirodiclofen per se and grape, citrus fruit, stone fruit, berry (crop group (CG) 13), and tropical fruit - the resid ue of concern for tolerance enforcement is spirodiclofen per se and residues of concern for risk assessment are spirodiclofen and BAJ 2510. HED notes that following: **(1)** BAJ 2510 is included as a residue of concern in grape, citrus fruit, stone fruit, berry

(CG 13), and tropical fruit due to the demonstrated (grape and citrus fruit) degradation of parent to BAJ 2510 during processing or due to the lack of data eliminating this possibility

(stone fruit, berry

CG 13, and tropical fruit); **(2)** BAJ 2510 is o nl y a residue of concern in the processed commodities of grape, citrus fruit, stone fruit, berry (CG 13), and tropical fruit ; and **(3)** if processing data for the combined residues of spirodiclofen and BAJ 2510Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### are not available, then the dietary anal ys is sh ould incorporate default processing factors. **Ba sed**  **on the results of the grape and orange processing studies, HED request ed**  **that all future processing studies monitor for residues of spirodiclofen, BAJ 2510, 3**  **- OH**  **- enol, and 4**  **- OH**  **** **enol.** Table 1 is a summary

of the se conclusions and conclusion relating to the residues of concern in ruminants and drinking water (Risk Assessment Document : D285047 , M Clock- Rust et al. , 22 - Jun - 2005 ) ; data relating to the residues of concern in poultry and rotational crops are not available. **Table 1 :**  **Residues of Concern**  **for Tolerance Expression and Risk Assessment .**  Matrix Residues included in Risk Assessment Residues included in Tolerance Expression Pome Fruit, Tree Nut , and Hops spirodiclofen spirodiclofen Grape , Citrus Fruit, Stone Fruit, Berry (CG 13) , and Tropical Fruit 1 spirodiclofen , BAJ 2510 spirodiclofen Livestock - Ruminants spirodiclofen, BAJ 2510 spirodiclofen, BAJ 2510 Livestock - Poultry no data submitted Rotational Crops no data submitted Drinking Water spirodiclofen, BAJ 2510, BAJ 2740 - dihydroxy, BAJ 2740 - ketohydroxy not applicable 1 BAJ 2510 is included as a residue of concern in grape, citrus fruit, stone fruit, berry (CG 13), and tropical fruit due to the demonstrated (grape and citrus fruit) degradation of parent to BAJ 2510 during processing or due to the lack of data eliminating this possibility (stone fruit , berry (CG - 13), and tropical fruit). BAJ 2510 is only a residue of concern in the processed commodities of grape, citrus fruit, stone fruit, berry (CG 13), and tropical fruit. If processing data for the combined residues of spirodiclofen and BAJ 2510 are not available, then the dietary analysis should incorporate default processing factors. 

### Recommended Tolerances: Based on the data submitted in support of the current petition, HED concluded that the following tolerances for residues of spirodiclofen per se are appropriate (D387339, T. Bloem, 15 - Oct - 2011): l ychee - 4.0 ppm; longan - 4.0 ppm; Spanish lime - 4.0 ppm; rambutan - 4.0 ppm; pulasan - 4.0 ppm; sugar apple - 0.40 ppm; atemoya - 0.40 ppm; custard apple - 0.40 ppm; cherimo ya - 0.40 ppm; ilama - 0.40 ppm; soursop - 0.40 ppm; birida - 0.40 ppm; guava - 0.50 ppm; feijoa - 0.50 ppm; jaboticaba - 0.50 ppm; wax jambu - 0.50 ppm; starfr uit - 0.50 ppm; passionfruit - 0.50 ppm; acerola - 0.50 ppm; and persimmon - 0.50 ppm. Plant Residues Used in the Chronic/Cancer Risk Assessments: The chronic and cancer dietary anal ys es incorporated the following: **(1)** average field trial residues (se e Table 2), **(2)** new use percent crop treated estimates for blueberry (2 % ) and hops (92% (s ee attachment s 1 and 2 ) ; **(3)** SLUA data when available (see attachment 3 ); and **(4)** default processing factors for all commodities excluding the processed commodities derived from pome fruit, citrus fruit, and grape where experimentally

determined processing factors were incorporated (see Table 2 ). HED notes that attachment 2 includes new use percent crop treated estimates for apple, grape, pe ach, and orange ; based on advice from BEAD, HED incorporated the SLUA data for these crops rather than the new use estimates . Livestock Residues Used in the Chronic/Cancer Risk Assessments: The recommended ruminant tolerances were based on maximum theoretical dietary burdens (no poultry/hog feed commodities proposed/registered). A more realistic dietary burden (DB) was calculated for ruminants using the revised OPPTS 860.1000 Table 1 feed s tuffs. Guidance provided along with the revised Table 1 indicates that all three feed commodities associated with spirodiclofen (dried citrus pulp (beef and dairy) , wet apple pomace (dairy onl y) , and almond hulls (dairy onl y) ) are considered alternativeSpirodiclofen Dietary Exposure and Risk Assessment D 387338

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### f eedstuffs and dietary

burdens should include only one alternative feedstuff . Of these three commodities, almond hulls and wet apple pomace yi elds the highest dietary burden estimates for dairy and beef cattle, respectivel y. The guidance associated with revised Table 1 indicates that almond hulls can be fed at up to 10% of the dairy cattle diet but 5% is more likely . Since the refined livestock residue estimates are for a chronic anal ys is, HED concluded that almond hulls will be consumed at 5% of the dairy cattle diet . In addition, the dietary burden calculations for dairy cattle were used for determination of residues in tissues as dairy cattle are ultimatel y slaughtered for meat (dairy cattle has a higher dietary burden) . Tables 3 and 4 are summaries of the dietary burden calculations and ruminant residue estimate, respectively . **Table 2:**  **Summary of Residue Estim**  **ates for the Chronic and Cancer Dietary Exposure Analyses.**  Matrix Avg Fld Trl Res and Proj . Rum

t, Residues (ppm) % Crop

Treated Estimates 1 Processing Factors Crop Translation and/or Comments pome fruit apple 2

- 0.146 5 apple sauce - 0.07x ; dried apple - 0.18x ; peeled apple - 0.15x ; juice - 0.03x - A pple and pear residues - D285249, T. Bloem, 18 - Apr - 2005 .

- A pple processing study - D341847, T. Bloem, 25 - Oct - 2007 ; dried apple and apple juice processing factors translated to dried pear and pear juice. pear2

- 0.239 1 0 dried pear - 0.18x ; pear juice

- 0.03x citrus fruit orange 2

- 0.104 1 0 peeled fruit - 0. 14 x; juice - 0.06 x; oil - 123 x; peel - 2 .2x - Orange, lemon, and grapefruit residues - D285249, T. Bloem, 18 - Apr - 2005.

- Orange processing stud ies - D285249, T. Bloem, 18 - Apr - 2005 and D390192, T. Bloem, 20 - Jun - 2011 ; orange processing data translated to all citrus commodities. lemon 2

- 0.121 1 grapefruit2

- 0.103 5 0 tree nut almond2

- 0.023 5 --

- Al mond and pecan residues - D285249, T. Bloem, 18 - Apr 2005. pecan 2

- 0.019 2 -- filbert - 0.019 2 -- pistachio - 0.023 1 -- walnut - 0.019 5 --

stone fruit peach 2

- 0.368 5 dried peach - 7.0x (default)

- Peach, plum and cherry residues - D285249, T. Bloem, 18 - Apr- 2005. plum2

- 0.068 5 prune dried - 5.0x (default) prune juice - 1.4x (default) cherry 2

- 0.286 2 juice - 1.5x (default) apricot - 0.368 5 apricot dried - 6.0 nectarines - 0.368 10 -- grape grape - 0.697 raisin - 10 table - 30 wine - 5 raisin - 4.3x; juice - 0.17x - Grape residues - D285249, T. Bloem, 18 - Apr - 2005; grape processing factors - D341847, T. Bloem, 25 - Oct - 2007. The table grape percent crop treated was translated to juice grape (table grape was the highest) hops hops - 11.6 92 -- - Hops residues - 47105301.der.doc (14 - day PHI ). avocado avocado - 0.110 100 papaya dried - 1.8x (default) papaya juice - 1.5x (default - Avocado residue data (D363343, T. Bloem, 23 - Sep - 2009) translated to black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple based on Reviewer’s Guide and Summary of HED ChemSAC Approvals for Amending Commodity Definitions [ 40CFR § 180.1(h)] and Crop Group/Subgroups [40 CFR § 180.41] (B. Schneider; 14 - Jun 2002). Default processing factors assumed for papaya. b ushberry 13 - 07B lowbush blueberry -

1.305 blueberry - 2 -- - L owbush blueberry residue translated to the remaining members of the bushberry subgroup 13 - 07B ( 47886201.der.doc )Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 5 of 26 **Table 2:**  **Summary of Residue Estim**  **ates for the Chronic and Cancer Dietary Exposure Analyses.**  Matrix Avg Fld Trl Res and Proj . Rum

t, Residues (ppm) % Crop

Treated Estimates 1 Processing Factors Crop Translation and/or Comments cattle, goat, sheep, horse liver - 0.0009 -- --

- See Tables 3 and 4 .

- Residue in kidney translated to meat byproducts (highest of liver, kidney, and fat) .

- Since spirodiclofen may concentrate in milk fat (Kow=5.83), residues in milk fat were estimated using the default 25x milk fat concentration factor (0.0002 ppm x 25 = 0.005 ppm). kidney - 0.004 -- -- muscle - 0.0001 -- dried beef - 1.92x (default) fat - 0.0007 -- -- meat bypdcts - 0.00 4 -- -- whole milk - 0.0002 -- -- milk fat - 0.005 -- -- 1 See attachment s 1 , 2, and 3 . 2 Residues in the representative crops translated to the remaining crops according to HED SOP 2000.1. **Table 3: Calculation of Spirodiclofen Dietary Burdens.**  Feed Commodity % Dry Matter 1 % Diet 1 Average Residue (ppm) 2 Dietary Contribution (ppm) 3 **Beef Cattle** dried citrus pulp 91 10 0.16 0.018 MTDB -- -- -- **0.018 Dairy**  **Cattle** almond hull 90 5 7.205 0.40 MTDB -- -- -- **0.40** 1 Revised Table 1 Feedstuffs (June 2008). 2 Average almond hull dried citrus pulp residue ( D285249, T. Bloem, 18 - Apr- 2005) 3 Dietary contribution = tolerance  % dry matter x % diet. **Table 4: Summary of Cattle Feeding Study and Projected Residue.** Dose; ppm (DBx) Residue (ppm) Projected Residue Assuming a 0.40 ppm dietary burden Spirodiclofen BAJ 2510 Total **liver** 1.38 (3.4x) not analyzed 4.12 (10.3x) not analyzed 13.75 (34.4x) <0.01 0.01 - 0.02 <0.02 - <0.03 0.0009 **kidney** 1.38 (3.4x) not analyzed 4.12 (10.3x) <0.01 <0.01 - 0.03 <0.01 - <0.04 0.004 13.75 (34.4x) <0.01 0.04 - 0.09 <0.05 - <0.10 0.003 **muscle** 1.38 (3.4x) not analyzed 4.12 (10.3x) not analyzed 13.75 (34.4x) <0.002 <0.002 <0.004 0.0001 **fat** 1.38 (3.4x) not analyzed 4.12 (10.3x) <0.002 <0.002 <0.004 0.0004 13.75 (34.4x) 0.003 - 0.021 <0.002 - 0.008 <0.005 - 0.024 0.0007 **wh ole m** **ilk**

**(days 4, 8, 12, 16, 20, 24, 26, and 28) 1**  1.38 (3.4x) not analyzed 4.12 (10.3x) not analyzed 13.75 (34.4x) <0.001 - 0.003 <0.001 - 0.003 <0.002 - 0.006 0.0002 **wh ey**  **2** 1.38 (3.4x) not analyzed 4.12 (10.3x) not analyzed 13.75 (34.4x) <0.001 <0.001 - 0.001 <0.002 0.00006Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 6 of 26 **Table 4: Summary of Cattle Feeding Study and Projected Residue.** Dose; ppm (DBx) Residue (ppm) Projected Residue Assuming a 0.40 ppm dietary burden Spirodiclofen BAJ 2510 Total **cream 2**  1.38 (3.4x) not analyzed 4.12 (10.3x) not analyzed 13.75 (34.4x) 0.005 - 0.012 <0.002 - 0.002 <0.008 - <0.014 0.0004 1 In milk collected from animals dosed at 13.75 ppm, combined residues of spirodiclofen and BAJ 2510 reached a plateau within the first week of treatment (  0.004 ppm); however, a peak of 0.006 ppm was observed in a single animal on day 20 of dosing. 2 A milk sample collected from animals dosed at 13.75 ppm with combined residues of 0.004 ppm was processed into whey and cream. 

### III. Drinking Water Data S urface and ground estimated drinking water concentrations were previously generated by the Environmental Fate and Effects Division (EFED) us ing PRZM - EXAMS and Screening Concentration in Ground Water Model ( SCI - GROW ) , respectivel y ( D311291, F. Kahn, 4 - Jan 2005) . The SCI - GROW model was run using the highest application rate (1 x 0.53 lb ai/acre) and resulted in a point estimate of 0.44 ppb. Multiple crop scenarios were modeled using PRZM EXAMS (citrus, pecan, apple, peach, and grape; 87% cropped and 100% crop treated assumed) with citrus (1 x 0.31 lb ai/acre) resulting in the highest 1 - in - 10 - ye ar peak concentration (23.86 ppb), 1 - in - 10 - ye ar ye arl y average (4.99 ppb), and 30 - ye ar average (1.67 ppb). Since the application rates proposed as part of the current petition (1 x 0 . 31 lb ai/acre) are equal to the citrus application rate, EFED conclude d that the previously generated water estimates remain relevant (D386204, L. Liu, 14 - Apr- 2011) . Therefore, the chronic and cancer analyses employed the citrus 1 - in - 10 - year ye arl y average (4.99 ppb) and 30 - ye ar average (1.67 ppb), respectivel y. **IV. DEEM**  **- FCID**   **Program and Consumption Information**  Spirodiclofen chronic dietary exposure assessments were conducted using the DEEM - FCID  (ver. 2.03), which incorporates consumption data from USDA’s CSFII (1994 - 1996 and 1998). The 1994 - 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey

days. Foods “as consumed” ( i.e. , apple pie) are linked to EPA - defined food commodities ( i.e. , apples, peeled fruit - cooked; fresh or N/S; baked; or wheat fl our - cooked; fresh or N/S, baked) using publicl y 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, but for acute exposure assessment are retained as individual consumption events. Based on anal ys is of the 1994 - 96, 98 CSFII 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 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ years old. For chronic dietary

exposure assessment, an estimate of the residue level in each food or food form ( i.e. , orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form. The resulting residue consumption estimate for each food/food form is summed with the residue consumption 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 s ubgroup.Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### IV. **Toxicological Information** Table 5 below summarizes the end points selected for dietary exposure analyses; for more detailed discussion on these endpoints see the HED risk assessment D3 86201 ( in draft). **Table 5:**  **Summary of Toxicological Doses and Endpoints .**  Exposure/ Scenario Point of

Departure Uncertainty/FQPA

Safety Factors RfD, PAD, Level

of Concern Study and Toxicological Effects Acute Dietary An appropriate endpoint attributable to a single dose was not identified. Chronic Dietary (All Populations) NOAEL=

1.38 mg/kg/day UF = 100

FQPA SF= 1x c RfD = 0.014

mg/kg/day cPAD = 0.014 mg/kg/day Chronic Oral Toxicity Study in Dogs : LOAEL= 4.7

mg/kg/day based on increased relative adrenal weights in both sexes, increased relative testis weight in males and histopathology findings in the adrenal gland of both sexes. Cancer Classification: “Likely to be Carcinogenic to Humans” with Q 1 * (mg/kg/day) - 1 = 1.49 x 10 - 2

. 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 releva nt human exposures. NOAEL = no - observed adverse - effect lev el. LOAEL = lowest - observed adverse - effect level. UF = uncertainty factor. FQPA SF = FQPA Safety Factor. RfD = reference dose. 

### V. **Results/Discussion** The chronic risk estimates (food and water) were ≤3. 2 % cPAD and are not of concern to HED ( children 1 - 2 ye ar s old were the most highly exposed population ; see Table 6 ). The cancer risk estimate (food and water) for the U.S. population was 3 x 10 - 6 

### (see Table 7) **Table 6: Summary of Chronic Dietary Exposure and Risk.**  Population Subgroup cPAD (mg/kg/day) Exposure (mg/kg/day) %cPAD 1 General U.S. Population

0.014 0.0002 41 1.7 All Infants (< 1 year old) 0.000 434 3. 1 **Children 1 -**  **2 years old 0.000**  **444 3.**  **2** Children 3 - 5 years old 0.000 348 2. 5 Children 6 - 12 years old 0.000 193 1. 4 Youth 13 - 19 years old 0.0001 36 1. 0 Adults 20 - 49 years old 0.000 268 1.9 Adults 50+ years old 0.000 198 1.4 Females 13 - 49 years old 0.000 183 1.3 1 The bolded %cPAD represents the population with highest risk. **Table 7:**  **Summary of Cancer Dietary Exposure and Risk.** Population Subgroup Q 1 * Exposure (mg/kg/day) Risk General U.S. Population 0.0149 0.000 171 2.6 x 1 0 - 6Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### VI. **Characterization of Inputs/Outputs** The chronic and cancer analyses assumed the following : **(1)** average field trial residues (food and feed commodities); **(2)** experimentally determined processing factors for citrus fruit, pome fruit, and grape (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); **(3)** B EAD new use percent crop treated estimates for hops (92%) and blueberry (2%) and the following SLUA data: almond - 5%; apple - 5%; apricot - 5%; cherry - 2%; grapefruit - 50%; grapes, raisin - 10%; grape, table - 30%; grape, wine - 5% - ; hazelnuts - 2%; lemo n - 1%; nectarine - 10%; orange - 10%; peach - 5%; pear - 10%; pecan - 2%; pistachio - 1%; plum/prune

- 5%; and walnuts - 5%; **(4)** livestock residues which incorporated average field trial residues for determination of the livestock dietary burdens; and **(5 )**  drinking water estimates derived from the PRZM/EXAMS model (citrus application scenario; 1 x 0.31 lb ai/acre; citrus yielded the highest chronic/cancer drinking water estimates). Since the anal ys is incorporated average residues derived from crop field trial studies (maximum application rate and minimum preharvest interval) and incorporated surface drinking water estimates which assumed 87% of the basin i s cropped and 100% of the crops are treated at the maximum rate, HED concludes that the exposure estimates provided in this document are unlikely to underestimate actual exposure. HED is generally

concerned when the cancer risk exceeds 10 - 6



### . Based on a critical commodity anal ys is conducted in DEEM - FCID  , the major contributors to the cancer risk were hops ( 44 % of the total exposure) and water ( 21 % of the total exposure). HED notes the following concerning the assumptions incorporated into the cancer anal ysis for hops and water : **(1)** hop s - DEEM FCID  assumes that 100% of the residue in hops are transferred to beer during the brewing process (no residue s remain in/on the spent hops); based on the spirodiclofen log KOW 

### of 5.83, this is a conservative assumption; in addition, assumed 92% crop treated for hops (new use percent crop treated estimates which is designed to provide a conservative estimate of actual percent crop treated) and **(2)** water - the water residue estimate assumed 87% of the basin is cropped with 100% of the crops treated at the maximum labeled rate. Therefore, HED concludes that the cancer risk estimate provided in this assessment is conservative and actual cancer risk will be lower than the estimate provided in this document (2.6 x 10 - 6 

### ).Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### VII. **Conclusions** C hronic and cancer dietary risk assessments were conducted using the DEEM - FCID  (ver. 2.03) which incorporates consumption data from USDA CSFII ( 1994 - 1996 and 1998). The chronic and cancer analyses assumed the following: **(1)** average field trial residues (food and feed commodities); **(2)** experimentally determined processing factors for citrus fruit, pome fruit, and grape (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); **(3)** B EAD new use percent crop treated estimates for hops (92% ) and blueberry (2%) , and screening level usage anal ys is (SLUA) data when available; **(4)** livestock residues which incorporated average field trial residues for determination of the livestock dietary burdens; and **(5 )**  drinking water estimates derived from th e PRZM/EXAMS model (citrus application scenario; 1 x 0.31 lb ai/acre). The resulting chronic risk estimates (food and water) were ≤3. 2 % the cPAD and are not of concern to HED ( children 1 - 2 years old were the most highly exposed population). The cancer ri sk estimate (food and water) for the U.S. population was 3 x 10 - 6 

### . The major contributors to the cancer analysis were hops (44%; assumes 100% transfer of residues from hops to beer; spirodiclofen Log KOW 

### = 5.83) and water (21%; 87% of the basin cropped and 100% crop treated at the maximum labeled rate). **VIII. List of Attachments**  Attachment 1: BEAD New Use Percent Crop Treated E stimates (D387916, J. Alsadek) . Attachment 2: BEAD New Use Percent Crop Treated Estimates ( D340691, J. Alsadek) . Attachment 3 : BEAD Spirodiclofen S LUA . Attachment 4 : DEEM - FCID  C hronic Residue F ile . Attachment 5 : DEEM - FCID  C hronic Exposure E stimates . Attachment 6 : DEEM - FCID  C ancer Residue F ile . Attachment 7 : DEEM - FCID  C ancer Exposure E stimates . Attachment 8 : DEEM - FCID  C ritical C ommodity Anal ys is for C ancer . cc with all attachments: B. Madden/Laura Nollen (RD; RM 0 5 ; 7505P ) T. Bloem:S10945:Potomac Yard 1:703 - 605 - 0217:7509P:RAB1Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 10 of 26 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION **UNITED ST AT**  **ES ENVIRONMENT AL**  **PROTECTION A GENCY** 

WA SHINGTON, D.C. 20460 

### Attachment 1: BEAD New Use Percent Crop Treated E stimates

– Blueberry (D387916, J. Alsadek) .

**MEMORANDUM SUBJECT:**  Percent Crop Treated for Proposed New Use of Spirodiclofen on Blueberries

(PC# 124871, DP# 387916) **FROM:** Jihad Alsadek, Ph.D., Economist

Science Information and Analy sis Branch David W. Brassard, Senior Entomologist Biological Anal ys is Branch Biological and Economic Analysis Division (7503P) **THRU:** Diann Sims, Chief

Science Information and Analysis Branch Arnet Jones, Chief Biological Anal ys is Branch Biological and Economic Analysis Division (7503P) **TO:** Laura Nollen, Biologist

Barbara Madden, Team Leader Risk Integration, Minor Use, and Emergency Response Branch Registration Division (7505P) Product Review Panel: June 8th, 2011 **I. SUMMARY**  Inthis memorandum, BEAD is providing a percent crop treated estimate for the proposed new use (PCTn) of the miticide spirodiclofen on blueberries as shown in Table 1. BEAD has examined the relevant data and concludes that it is unlikely that the actual percent crop treated (PCT) with spirodiclofen will exceed the PCTn for blueberries within the next five years. The general methodology

used to produce these estimates is des cribed in the recommended Federal Register (FR) language, and an analy sis of biological information describes relevant information that supports the likelihood that the PCTn estimates 

### for spirodiclofen are not likely to beSpirodiclofen Dietary Exposure and Risk Assessment D 387338

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### exceeded. **II. FEDERAL REGISTER LANGUAGE**  The EPA estimate of the percent crop treated for the new use (PCTn) of spirodiclofen represents the upper bound of use expected during the pesticide’s initial five years of registration; that is, the PCTn for spirodiclofen is a threshold of use that EPA is reasonabl y certain will not be exceeded for this registered use site. The PCTn recommended for use in the chronic dietary assessment is calculated as the average percent crop treated (PCT) of the miticide with the highest usag e (i.e., the miticides with the greatest PCT) on that crop over the three most recent ye ars of available data. The PCTn recommended for use in the chronic dietary assessment is 2% for blueberries. The PCTn recommended for use in the acute dietary assessm ent is the maximum observed PCT over the same period, which in this case is 2%. Comparisons are onl y made among pesticides of the same pesticide type (i.e., the miticide with the highest usage on the use crop is selected for comparison with a new miticide ). The highest miticide PCT included in the estimation may

not be the same for each year since different miticides may have the highest usage in different ye ars. Ty pically , EPA uses USDA/National Agricultural Statistics Service (NASS) surveys as the so urce data because they

are publicl y available and directly report values for PCT. When a specific use crop is not reported by USDA/NASS, EPA uses proprietary data and calculates the PCT based on reported data on acres treated and acres grown. If no proprietary data are available, EPA may

extrapolate PCTn from other crops if the production area and pest spectrum are substantiall y similar. A retrospective anal ys is to validate this approach shows few cases where the PCT for the highest miticides were exceed ed, (EPA, 2006). Further review of these cases identified factors contributing to the exceptionally high use of a new pesticide. To evaluate whether the PCTn for spirodiclofen could be exceeded, EPA considered whether or not there may be unusually high p est pressure, as indicated in emergency exemption requests for spirodiclofen, the pest spectrum of the new pesticide in comparison with the highest miticides, whether or not the highest miticides are well - established for that use, and whether or not pest r esistance issues with past miticides provide spirodiclofen with significant market potential. Given currentl y available information, BEAD concludes that it is unlikely that actual PCT for spirodiclofen will exceed the estimated PCT for new uses during the next five years. **III. PROJECTIONS BASED ON THE MARKET LEADER APPROACH**  For this anal ys is, BEAD used the market leader approach to derive the PCT values for blueberries as shown in Table 1. In this approach market leaders were selected from the pool of miticides currentl y used on blueberries instead of across all insecticides. BEAD believes this approach is more appropriate in this instance since spirodiclofen is a miticide. The approach utilizes PCT data for the chemicals that dominate the miticide m arket to assign a conservative upper bound PCT value for the new use. The market leader approach is backed b y an analysis conducted b y EPA in 2006 which compared the PCT of newly registered pesticides (from tolerances established over a 10 year period) to the PCT of the pesticides with the highest usage over that same period. In thisSpirodiclofen Dietary Exposure and Risk Assessment D 387338

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### anal ys is, BEAD found that over 95% of the time, the proportion of usage of a new pesticide or new use of a registered pesticide is not likely to exceed the usage observed in the most widely used pesticide type (i.e. miticide in this case) and crop within the first five years following registration, (EPA, 2006). The PCT value is taken directly from NASS data, or if proprietary data are used, BEAD calculates the PCT value b y dividing the base area treated (the area treated at least one time b y a given pesticide) b y the crop acres grown and multiplying the value b y 100. The miticide with the highest PCT for each data year was designated as the market leader and the PCT value s associated with the miticide market leader were used to derive the PCTn values for the new crop use of spirodiclofen. The PCTn values to be used in chronic risk assessments for new uses are derived b y taking the average of the highest PCT values and the PCTn value to be used in acute risk assessments is the highest value among the available years of PCT data. BEAD reviewed USDA/ NASS for miticide usage data on blueberries (2003 - 2009) to derive the PCTn values as shown in Table 1. **Table 1. Spirodiclofen Percent Crop Treated for a New Use (PCTn) for B**  **lueberries**

Sources: USDA/NASS, Agricultural Chemical Usage 2003, 2005, and 2009 Fruit Summaries **IV. ADDITIONAL FACTORS**  There are three main factors that BEAD considers in evaluating the likelihood that use of a newly registered chemical or a new use will exceed the PCT for new uses: (1) the extent of pest pressure on the crops in question; (2) the pest spectrum of the new miticide in comparison with the miticides with the highest usage as well as whether the miticides with the highest usage are well - established for this us e; and (3) resistance concerns with the new miticide and the miticides with the highest usage. High pest pressure with the lack of registered controls could indicate significant potential demand for a new chemical. Emergency exemptions under Section 18 o f FIFRA are a good indicator in regard to these situations. On the other hand, it would be relativel y difficult for a new active ingredient to gain a large portion of the market if a) it competes with the miticides with the highest usage or others that have been extensively used for pest control including the same target pest(s), b) its new use is limited, for example, registered only for a single pest, and/or c) it is labeled for pest(s) of minor economic concern. Finall y, if the target pests are develop ing resistance to the market leader(s), it could indicate an advantage for the new active ingredient in the market. Spirodiclofen is a tetronic acid with acaricidal action. It acts by interfering with mite development, and is labeled for control of spider mites, rust mites, European red mite, citrus red **Crop/New Use**  **Miticide Year**  **Miticide % (PCT)**  **Chronic**

**Risk/ Avg. PCT**  **Acute Risk/**

**Max. PCT** Blueberries Endosulfan

Endosulfan Endosulfan 2003

2005 2009 2

2 

### 1 2 2Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### mite, and grape erineum mite. Spirodiclofen displays contact activity to mite eggs, all ny mphal stages, and adult females (adult males are not a ffected). Spirodiclofen also suppresses San Jose scales. Spirodiclofen is currentl y registered for use on avocado, Christmas tree s, citrus crops, grapes, papaya, pome fruits, stone fruits, and tree nuts.  

### Pest pressure: No FIFRA Section 18 Emergency Exemptions have been issued for the use of spirodiclofen on blueberry .  

### Pest spectrum: The market leader miticides/ insecticide, endosulfan, is effective against a wide variety of insect and mite pests but, like spirodiclofen, is only registered to control blueberry bud mite in blueberry . Endosulfan is the most commonly used acaricide for the control of blueberry

bud mites (Jenkins et. al., 2008). Historically , endosulfan has been applied to 1 to 2% of U.S. blueberries (USDA/NASS, 2011). Bifenazate and spiromesifen are also registered for control of mites on blueb erries (NPIRS 2011).  

### Resistance: There is no documented resistance to the blueberry bud mite in the U.S. (Arthropod Pesticide Resistance Database). **IV. CONCLUSIONS/RECOMMENDATIONS**  BEAD recommends that the average PCTn value for blueberries be used in the chronic dietary risk assessment for spirodiclofen and the maximum PCTn value be used for acute risk assessment as shown in Table 1. BEAD has considered all available relevant in formation and believes it is unlikely that the above PCT values will be exceeded during the next five years. **VI. REFERENCES:**  Arthropod Pesticide Resistance Database. 2011. Available at: http://www.pesticideresistance.org/search/1/ Accessed: May 5, 2011. EPA 2006, Memorandum: “BEAD Approach to Providing Projected Percent Crop Treated Estimates for Use in Dietary Risk Assessment in OPP”, December 14, 2006. Unpublished Jenkins, P. et. al. 2008. Pest Management Strategic Plan for the North Central Region B lueberry Industry . http://www.ipmcenters.org/pmsp/pdf/MI - INblueberryPMSP.pdf NPIRS 2011. National Pesticide Information Retrieval System. http://npirs.ceris.purdue.edu USDA/ NASS. Agricultural Chemical Usage 2003, 2005, and 2009 Fruit Summaries http://www.pestmanagement.info/nass/app_usage.cfm http://quick stats.nass.usda.gov/results/1B5A8EE8 - DD63 - 337C - BF3C 62B4038A8B3F#0484BA58 - FC01 - 3CF4 - AC4B - 9314BAF11D08Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### Attachment **2 :**  BEAD New Use Percent Crop Treated Estimates (J. Alsadek, D340691, Aug - 2007) . **Crop/New Use Market Leader**  **AVG. PCT/Chronic Max.**  **PCT/Acute Year**  **ML Avg.**  Hops Abamectin Abamectin 97 92 99

84 **92 99**  Oranges, excluding Temples Abamectin Abamectin Abamectin 05 03 01 16

12 14 **14 16**  Grapes, All Fenpropathrin/Imidacloprid Abamectin Propargite 05 03 01 8

5 9 **7 9**  Peaches Hexythiazox Fenbutatin - oxide Fenbutatin - oxide 05 03 01 7

11 13 **10 13**  Apples Py ridaben Fenpropathrin/Formetanate Py ridaben 05 03 01 16

12 17 **15 17**  

### References: National Center for Food & Agricultural Policy (NCFAP), 1992 and 1997 Agricultural Chemical Usage 2001 Fruit Summary , August 2002 Agricultural Chemical Usage 2003 Fruit Summary, August 2004 Agricultural Chemical Usage 2005 Fruit Summary, July 2006Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### Attachment **3 :**  BEAD Spirodiclofen SLUA .Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 16 of 26Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 17 of 26Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### Attachment **4 :**  DEEM - FCID  C hronic Residue F ile . Filename: C: \ Documents and Settings \ tbloem \ spirodiclofen \ tropical fruit 2 \ 124871chronic.R98 Chemical: spirodiclofen RfD(Chronic): .014 mg/kg bw/day NOEL(Chronic): 1.38 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Q*= .0149 Date created/last modified: 09 - 21 - 2011/08:59:51/8 Program ver. 2.03 Comment: no acute endpoint identified; 100x uncertainity factor for chronic

-------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 10001060 10 Citrus citron 0.104000 0.140 1.000 10001070 10 Citrus hybrids 0.104000 0.140 1.000 10001080 10 Citrus, oil 0.121000 123. 1.000 10001800 10 Grapefruit 0.103000 0.140 0.500 10001810 10 Grapefruit, juice 0.103000 0.060 0.500 10001970 10 Kumquat 0.104000 0.140 1.000 10001990 10 Lemon 0.121000 0.140 0.010 10002000 10 Lemon, juice 0.121000 0.060 0.010 10002001 10 Lemon, juice - babyfood 0.121000 0.060 0.010 10002010 10 Lemon, peel 0.121000 2.200 0.010 10002060 10 Lime 0.121000 0. 140 1.000 10002070 10 Lime, juice 0.121000 0.060 1.000 10002071 10 Lime, juice - babyfood 0.121000 0.060 1.000 10002400 10 Orange 0.104000 0.140 0.100 10002410 10 Oran ge, juice 0.104000 0.060 0.100 10002411 10 Orange, juice - babyfood 0.104000 0.060 0.100 10002420 10 Orange, peel 0.104000 2.200 0.100 10003070 10 Pummelo 0.103000 0.140 1.000 10003690 10 Tangerine 0.104000 0.140 1.000 10003700 10 Tangerine, juice 0.104000 0.060 1.000 11000070 11 Apple, fruit with peel 0.146000 1.000 0.050 11000 080 11 Apple, peeled fruit 0.146000 0.150 0.050 11000081 11 Apple, peeled fruit - babyfood 0.146000 0.150 0.050 11000090 11 Apple, dried 0.146000 0.180 0.050 11000091 11 Apple, dried - babyfood 0.146000 0.180 0.050 11000100 11 Apple, juice 0.146000 0.030 0.050 11000101 11 Apple, juice - babyfood 0.146000 0.030 0.050 11000110 11 Apple, sauce 0.146000 0.070 0.050 11000111 11 Apple, sauce - babyfood 0.146000 0.070 0.050 11001290 11 Crabapple 0.146000 1.000 1.000 11002100 11 Loquat 0.239000 1.000 1.000 11002660 11 Pear 0.239000 1.000 0.100 11002661 11 Pear - babyfood 0.239000 1.000 0.100 11002670 11 Pear, dried 0.239000 0.180 0.100 11002680 11 Pear, juice 0.239000 0.030 0.100 11002681 11 Pear, juice - babyfood 0.239000 0.030 0.100 11003100 11 Quince 0.239000 1.000 1.000 12000120 12 Apricot 0.368000 1.000 0.050 12000121 12 Apricot - babyfood 0.368000 1.000 0.050 12000130 12 Apricot, dried 0.368000 6.000 0.050 12000140 12 Apricot, juice 0.368000 1. 000 0.050 12000141 12 Apricot, juice - babyfood 0.368000 1.000 0.050 12000900 12 Cherry 0.286000 1.000 0.020 12000901 12 Cherry - babyfood 0.286000 1.000 0.020 12000910 12 Cher ry, juice 0.286000 1.500 0.020 12000911 12 Cherry, juice - babyfood 0.286000 1.500 0.020 12002300 12 Nectarine 0.368000 1.000 0.100 12002600 12 Peach 0.368000 1.000 0.050 12002601 12 Peach - babyfood 0.368000 1.000 0.050Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 19 of 26 12002610 12 Peach, dried 0.368000 7.000 0.050 12002611 12 Peach, dried - babyfood 0.368000 7.000 0.050 12002 620 12 Peach, juice 0.368000 1.000 0.050 12002621 12 Peach, juice - babyfood 0.368000 1.000 0.050 12002850 12 Plum 0.068000 1.000 0.050 12002851 12 Plum - babyfood 0.068000 1.000 0.050 12002860 12 Plum, prune, fresh 0.068000 1.000 0.050 12002861 12 Plum, prune, fresh - babyfood 0.068000 1.000 0.050 12002870 12 Plum, prune, dried 0.068000 5.000 0.050 12002871 12 Plum, prune, dried - babyfood 0.068000 5.000 0.050 12002880 12 Plum, prune, juice 0.068000 1.400 0.050 12002881 12 Plum, prune, juice - babyfood 0.068000 1.400 0.050 13020570 13B Blueberry 1.305000 1.000 0.020 13020571 13B Blueberry - babyfood 1.305000 1.000 0.020 13021360 13B Currant 1.305000 1.000 1.000 13021370 13B Currant, dried 1.305000 1.000 1.000 13021490 13B Elderberry 1.305000 1.000 1.000 13021740 13B Gooseberry 1.305000 1.000 1.000 13021910 13B Huckleberry 1.305000 1. 000 1.000 14000030 14 Almond 0.023000 1.000 0.050 14000031 14 Almond - babyfood 0.023000 1.000 0.050 14000040 14 Almond, oil 0.023000 1.000 0.050 14000041 14 Almo nd, oil - babyfood 0.023000 1.000 0.050 14000590 14 Brazil nut 0.019000 1.000 1.000 14000680 14 Butternut 0.019000 1.000 1.000 14000810 14 Cashew 0.019000 1.000 1.000 14000920 14 Chestnut 0.023000 1.000 1.000 14001550 14 Filbert 0.019000 1.000 0.020 14001560 14 Filbert, oil 0.019000 1.000 0.020 14001 850 14 Hickory nut 0.019000 1.000 1.000 14002130 14 Macadamia nut 0.019000 1.000 1.000 14002690 14 Pecan 0.019000 1.000 0.020 14002820 14 Pistachio 0.023000 1.000 0.010 14003910 14 Walnut 0.019000 1.000 0.050 21000440 M Beef, meat 0.000100 1.000 1.000 21000441 M Beef, meat - babyfood 0.000100 1.000 1.000 21000450 M Beef, meat, dried 0.000100 1.920 1.000 21000460 M Beef, meat byproducts 0.004000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 0.004000 1.000 1.000 21000470 M Beef, fat 0.000700 1.000 1.000 21000471 M Beef,fat - babyfood 0.000700 1.000 1.000 21000480 M Beef, kidney 0.004000 1.000 1.000 21000490 M Beef, liver 0.000900 1.000 1.000 21000491 M Beef, liver - babyfood 0.000900 1.000 1.000 23001690 M Goat, meat 0.000100 1.000 1.000 23001700 M Goat, meat byprod ucts 0.004000 1.000 1.000 23001710 M Goat, fat 0.000700 1.000 1.000 23001720 M Goat, kidney 0.004000 1.000 1.000 23001730 M Goat, liver 0.000900 1. 000 1.000 24001890 M Horse, meat 0.000100 1.000 1.000 26003390 M Sheep, meat 0.000100 1.000 1.000 26003391 M Sheep, meat - babyfood 0.000100 1.000 1.000 26003400 M Shee p, meat byproducts 0.004000 1.000 1.000 26003410 M Sheep, fat 0.000700 1.000 1.000 26003411 M Sheep, fat - babyfood 0.000700 1.000 1.000 26003420 M Sheep, kidney 0.004000 1.000 1.000 26003430 M Sheep, liver 0.000900 1.000 1.000 27002220 D Milk, fat 0.005000 1.000 1.000 27002221 D Milk, fat - baby food/infant for 0.005000 1.000 1.000 27012 230 D Milk, nonfat solids 0.000200 1.000 1.000 27012231 D Milk, nonfat solids - baby food/in 0.000200 1.000 1.000 27022240 D Milk, water 0.000200 1.000 1.000 27022241 D Milk, water - babyfood/i nfant form 0.000200 1.000 1.000Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 20 of 26 27032251 D Milk, sugar (lactose) - baby food/ 0.000200 1.000 1.000 86010000 O Water, direct, all sources 0.004990 1.000 1.000 86020000 O Water, indirect, all sources 0.004990 1.000 1.000 95000010 O Acerola 0.500000 1.000 1.000 95000200 O Avocado 0.110000 1.000 1.000 95000740 O Canistel 0.110000 1.000 1.000 95000890 O Cherimoya 0.400000 1.000 1.000 95001510 O Feijoa 0.500000 1.000 1.000 95001750 O Grape 0.697000 1.000 0.300 95001760 O Grape, juice 0.697000 0.170 0.300 95001761 O Grape, juice - babyfood 0.697000 0.170 0.300 95001770 O Grape, leaves 0.697000 1.000 0.300 95001780 O Grape, raisin 0.697000 4.300 0.100 95001790 O Grape, wine and sherry 0.697000 1.000 0.050 95001830 O Guava 0.500000 1.000 1.000 95001831 O Guava - babyfood 0.500000 1. 000 1.000 95001880 O Hop 11.600000 1.000 0.920 95001920 O Jaboticaba 0.500000 1.000 1.000 95002090 O Longan 4.000000 1.000 1.000 95002110 O Lych ee 4.000000 1.000 1.000 95002120 O Lychee, dried 4.000000 1.000 1.000 95002150 O Mango 0.110000 1.000 1.000 95002151 O Mango - babyfood 0.110000 1.000 1.000 95002160 O Mango, dried 0.110000 1.000 1.000 95002170 O Mango, juice 0.110000 1.000 1.000 95002171 O Mango, juice - babyfood 0.110000 1.000 1.000 95002 450 O Papaya 0.110000 1.000 1.000 95002451 O Papaya - babyfood 0.110000 1.000 1.000 95002460 O Papaya, dried 0.110000 1.800 1.000 95002470 O Papaya, juice 0.110000 1.500 1.000 95002520 O Passionfruit 0.500000 1.000 1.000 95002521 O Passionfruit - babyfood 0.500000 1.000 1.000 95002530 O Passionfruit, juice 0.500000 1.000 1.000 95002531 O Passionfruit, juice - babyfood 0.500000 1.000 1.000 95002770 O Persimmon 0.500000 1.000 1.000 95003330 O Sapote, Mamey 0.110000 1.000 1.000 95003460 O Soursop 0.400000 1.000 1.000 95003510 O Spanish lime 4.000000 1.000 1.000 95003580 O Starfruit 0.500000 1.000 1.000 95003610 O Sugar apple 0.400000 1.000 1.000Spirodiclofen Dietary Exposure and Risk Assessment D 387338

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### Attachment **5** : DEEM - FCID  C hronic Exposure E stimates. U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for SPIRODICLOFEN (1994 - 98 data ) Residue file name: C: \ Documents and Settings \ tbloem \ spirodiclofen \ tropical fruit 2 \ 124871chronic.R98 Adjustment factor #2 used. Analysis Date 09 - 21 - 2011/09:00:51 Residue file dated: 09 - 21 - 2011/08:5 9:51/8 Reference dose (RfD, Chronic) = .014 mg/kg bw/day COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic

=============================================================================== Total exposure by pop ulation subgroup

------------------------------------------------------------------------------- Total Exposure

----------------------------------- Popula tion mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.000241 1.7% U.S. Population (spring season) 0.000252 1.8% U.S. Population (summer season) 0.000269 1.9% U.S. Population (autumn season) 0.000221 1.6% U.S. Population (winter season) 0.000222 1.6% Northeast region 0.000222 1.6% Midwest region 0.000251 1.8% Southern region 0.000216 1.5% Western region 0.000287 2.0% Hispanics 0.000246 1.8% Non - hispanic whites 0.000246 1.8% Non - hispanic blacks 0.000197 1.4% Non - hisp/non - white/non - black 0.000263 1.9% All infants (< 1 year) 0.000434 3.1% Nursing infants 0.000178 1.3% Non - nursing infants 0.000531 3.8% Children 1 - 6 yrs 0.000365 2.6% Children 7 - 12 yrs 0.000182 1.3% Females 13 - 19 (not preg or nursing) 0.000119 0.9% Females 20+ (not preg or nursing) 0.000189 1.3% Females 13 - 50 yrs 0.000197 1.4% Females 13+ (preg/ not nursing) 0.000172 1.2% Females 13+ (nursing) 0.000222 1.6% Males 13 - 19 yrs 0.000151 1.1% Males 20+ yrs 0.00030 1 2.1% Seniors 55+ 0.000189 1.4% Children 1 - 2 yrs 0.000444 3.2% Children 3 - 5 yrs 0.000348 2.5% Children 6 - 12 yrs 0.000193 1.4% Youth 13 - 19 yrs 0.000136 1.0% Adults 20 - 49 yrs 0.000268 1.9% Adults 50+ yrs 0.000198 1.4% Females 13 - 49 yrs 0.000183 1.3%

-------------------------------------------------------------------------------Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 22 of 26 

### Attachment **6 :**  DEEM - FCID  C ancer Residue F ile. Filename: C: \ Document s and Settings \ tbloem \ spirodiclofen \ tropical fruit 2 \ 124871cancer.R98 Chemical: spirodiclofen RfD(Chronic): .014 mg/kg bw/day NOEL(Chronic): 1.38 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Q*= .0149 Date created/last modified: 0 9 - 21 - 2011/09:00:33/8 Program ver. 2.03 Comment: no acute endpoint identified; 100x uncertainity factor for chronic

-------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 10001060 10 Citrus citron 0.104000 0.140 1.0 00 10001070 10 Citrus hybrids 0.104000 0.140 1.000 10001080 10 Citrus, oil 0.121000 123. 1.000 10001800 10 Grapefruit 0.103000 0.140 0.500 10001810 10 Grapefruit, juice 0.103000 0.060 0.500 10001970 10 Kumquat 0.104000 0.140 1.000 10001990 10 Lemon 0.121000 0.140 0.010 10002000 10 Lemon, juice 0.121000 0.060 0.010 10002001 10 Lemon, juice - babyfood 0.121000 0.060 0.010 10002010 10 Lemon, peel 0.121000 2.200 0.010 10002060 10 Lime 0.121000 0. 140 1.000 10002070 10 Lime, juice 0.121000 0.060 1.000 10002071 10 Lime, juice - babyfood 0.121000 0.060 1.000 10002400 10 Orange 0.104000 0.140 0.100 10002410 10 Oran ge, juice 0.104000 0.060 0.100 10002411 10 Orange, juice - babyfood 0.104000 0.060 0.100 10002420 10 Orange, peel 0.104000 2.200 0.100 10003070 10 Pummelo 0.103000 0.140 1.000 10003690 10 Tangerine 0.104000 0.140 1.000 10003700 10 Tangerine, juice 0.104000 0.060 1.000 11000070 11 Apple, fruit with peel 0.146000 1.000 0.050 11000 080 11 Apple, peeled fruit 0.146000 0.150 0.050 11000081 11 Apple, peeled fruit - babyfood 0.146000 0.150 0.050 11000090 11 Apple, dried 0.146000 0.180 0.050 11000091 11 Apple, dried - babyfood 0.146000 0.180 0.050 11000100 11 Apple, juice 0.146000 0.030 0.050 11000101 11 Apple, juice - babyfood 0.146000 0.030 0.050 11000110 11 Apple, sauce 0.146000 0.070 0.050 11000111 11 Apple, sauce - babyfood 0.146000 0.070 0.050 11001290 11 Crabapple 0.146000 1.000 1.000 11002100 11 Loquat 0.239000 1.000 1.000 11002660 11 Pear 0.239000 1.000 0.100 11002661 11 Pear - babyfood 0.239000 1.000 0.100 11002670 11 Pear, dried 0.239000 0.180 0.100 11002680 11 Pear, juice 0.239000 0.030 0.100 11002681 11 Pear, juice - babyfood 0.239000 0.030 0.100 11003100 11 Quince 0.239000 1.000 1.000 12000120 12 Apricot 0.368000 1.000 0.050 12000121 12 Apricot - babyfood 0.368000 1.000 0.050 12000130 12 Apricot, dried 0.368000 6.000 0.050 12000140 12 Apricot, juice 0.368000 1. 000 0.050 12000141 12 Apricot, juice - babyfood 0.368000 1.000 0.050 12000900 12 Cherry 0.286000 1.000 0.020 12000901 12 Cherry - babyfood 0.286000 1.000 0.020 12000910 12 Cher ry, juice 0.286000 1.500 0.020 12000911 12 Cherry, juice - babyfood 0.286000 1.500 0.020 12002300 12 Nectarine 0.368000 1.000 0.100 12002600 12 Peach 0.368000 1.000 0.050 12002601 12 Peach - babyfood 0.368000 1.000 0.050Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 23 of 26 12002610 12 Peach, dried 0.368000 7.000 0.050 12002611 12 Peach, dried - babyfood 0.368000 7.000 0.050 12002 620 12 Peach, juice 0.368000 1.000 0.050 12002621 12 Peach, juice - babyfood 0.368000 1.000 0.050 12002850 12 Plum 0.068000 1.000 0.050 12002851 12 Plum - babyfood 0.068000 1.000 0.050 12002860 12 Plum, prune, fresh 0.068000 1.000 0.050 12002861 12 Plum, prune, fresh - babyfood 0.068000 1.000 0.050 12002870 12 Plum, prune, dried 0.068000 5.000 0.050 12002871 12 Plum, prune, dried - babyfood 0.068000 5.000 0.050 12002880 12 Plum, prune, juice 0.068000 1.400 0.050 12002881 12 Plum, prune, juice - babyfood 0.068000 1.400 0.050 13020570 13B Blueberry 1.305000 1.000 0.020 13020571 13B Blueberry - babyfood 1.305000 1.000 0.020 13021360 13B Currant 1.305000 1.000 1.000 13021370 13B Currant, dried 1.305000 1.000 1.000 13021490 13B Elderberry 1.305000 1.000 1.000 13021740 13B Gooseberry 1.305000 1.000 1.000 13021910 13B Huckleberry 1.305000 1.000 1.000 14000030 14 Almond 0.023000 1.000 0.050 14000031 14 Almond - babyfood 0.023000 1.000 0.050 14000040 14 Almond, oil 0.023000 1. 000 0.050 14000041 14 Almond, oil - babyfood 0.023000 1.000 0.050 14000590 14 Brazil nut 0.019000 1.000 1.000 14000680 14 Butternut 0.019000 1.000 1.000 14000810 14 Cash ew 0.019000 1.000 1.000 14000920 14 Chestnut 0.023000 1.000 1.000 14001550 14 Filbert 0.019000 1.000 0.020 14001560 14 Filbert, oil 0.019000 1.000 0.020 14001850 14 Hickory nut 0.019000 1.000 1.000 14002130 14 Macadamia nut 0.019000 1.000 1.000 14002690 14 Pecan 0.019000 1.000 0.020 14002 820 14 Pistachio 0.023000 1.000 0.010 14003910 14 Walnut 0.019000 1.000 0.050 21000440 M Beef, meat 0.000100 1.000 1.000 21000441 M Beef, meat - babyfood 0.000100 1.000 1.000 21000450 M Beef, meat, dried 0.000100 1.920 1.000 21000460 M Beef, meat byproducts 0.004000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 0.004000 1.000 1.000 21000470 M Beef, fat 0.000700 1.000 1.000 21000471 M Beef,fat - babyfood 0.000700 1.000 1.000 21000480 M Beef, kidney 0.004000 1.000 1.000 21000490 M Beef, liver 0.000900 1.000 1.000 21000491 M Beef, liver - babyfood 0.000900 1.000 1.000 23001690 M Goat, meat 0.000100 1.000 1.000 23001700 M Goat, meat byprod ucts 0.004000 1.000 1.000 23001710 M Goat, fat 0.000700 1.000 1.000 23001720 M Goat, kidney 0.004000 1.000 1.000 23001730 M Goat, liver 0.000900 1. 000 1.000 24001890 M Horse, meat 0.000100 1.000 1.000 26003390 M Sheep, meat 0.000100 1.000 1.000 26003391 M Sheep, meat - babyfood 0.000100 1.000 1.000 26003400 M Shee p, meat byproducts 0.004000 1.000 1.000 26003410 M Sheep, fat 0.000700 1.000 1.000 26003411 M Sheep, fat - babyfood 0.000700 1.000 1.000 26003420 M Sheep, kidney 0.004000 1.000 1.000 26003430 M Sheep, liver 0.000900 1.000 1.000 27002220 D Milk, fat 0.005000 1.000 1.000 27002221 D Milk, fat - baby food/infant for 0.005000 1.000 1.000 27012 230 D Milk, nonfat solids 0.000200 1.000 1.000 27012231 D Milk, nonfat solids - baby food/in 0.000200 1.000 1.000 27022240 D Milk, water 0.000200 1.000 1.000 27022241 D Milk, water - babyfood/i nfant form 0.000200 1.000 1.000Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 24 of 26 27032251 D Milk, sugar (lactose) - baby food/ 0.000200 1.000 1.000 86010000 O Water, direct, all sources 0.001670 1.000 1.000 86020000 O Water, indirect, all sources 0.001670 1.000 1.000 95000010 O Acerola 0.500000 1.000 1.000 95000200 O Avocado 0.110000 1.000 1.000 95000740 O Canistel 0.110000 1.000 1.000 95000890 O Cherimoya 0.400000 1.000 1.000 95001510 O Feijoa 0.500000 1.000 1.000 95001750 O Grape 0.697000 1.000 0.300 95001760 O Grape, juice 0.697000 0.170 0.300 95001761 O Grape, juice - babyfood 0.697000 0.170 0.300 95001770 O Grape, leaves 0.697000 1.000 0.300 95001780 O Grape, raisin 0.697000 4.300 0.100 95001790 O Grape, wine and sherry 0.697000 1.000 0.050 95001830 O Guava 0.500000 1.000 1.000 95001831 O Guava - babyfood 0.500000 1. 000 1.000 95001880 O Hop 11.600000 1.000 0.920 95001920 O Jaboticaba 0.500000 1.000 1.000 95002090 O Longan 4.000000 1.000 1.000 95002110 O Lych ee 4.000000 1.000 1.000 95002120 O Lychee, dried 4.000000 1.000 1.000 95002150 O Mango 0.110000 1.000 1.000 95002151 O Mango - babyfood 0.110000 1.000 1.000 95002160 O Mango, dried 0.110000 1.000 1.000 95002170 O Mango, juice 0.110000 1.000 1.000 95002171 O Mango, juice - babyfood 0.110000 1.000 1.000 95002 450 O Papaya 0.110000 1.000 1.000 95002451 O Papaya - babyfood 0.110000 1.000 1.000 95002460 O Papaya, dried 0.110000 1.800 1.000 95002470 O Papaya, juice 0.110000 1.500 1.000 95002520 O Passionfruit 0.500000 1.000 1.000 95002521 O Passionfruit - babyfood 0.500000 1.000 1.000 95002530 O Passionfruit, juice 0.500000 1.000 1.000 95002531 O Passionfruit, juice - babyfood 0.500000 1.000 1.000 95002770 O Persimmon 0.500000 1.000 1.000 95003330 O Sapote, Mamey 0.110000 1.000 1.000 95003460 O Soursop 0.400000 1.000 1.000 95003510 O Spanish lime 4.000000 1.000 1.000 95003580 O Starfruit 0.500000 1.000 1.000 95003610 O Sugar apple 0.400000 1.000 1.000Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 25 of 26 

### Attachment **7 :**  DEEM - FCID  C ancer Exposure E stimates . U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for SPIRODICLOFEN (1994 - 98 data) Residue file name: C: \ Documents and Settings \ tbloem \ spirodiclofen \ tropical fruit 2 \ 124871cancer.R98 Adjustment factor #2 used. Analysis Date 09 - 21 - 2011/09:02:38 Residue file dated: 09 - 21 - 2011/09:00:33/8 Q* = 0.01 49 COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic

=============================================================================== Total exposure by population subgroup

------------------------------------ ------------------------------------------- Total Exposure

----------------------------------- Population mg/kg Lifetime risk Subgroup body wt/day (Q*= .0149)

-------------------------------------- ------------- ------------- U.S. Population (total) 0.000171 2.55E - 06

----------------------------------- --------------------------------------------Spirodiclofen Dietary Exposure and Risk Assessment D 387338

Page 26 of 26 

### Attachment **8 :**  DEEM - FCID  C ritical C ommodity Anal ys is for C ancer . U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for SPIRODICLOFEN (1994 - 98 data) Residue file name: C: \ Documents and Settings \ tbloem \ spirodiclofen \ tropical fruit 2 \ 124871cancer.R98 Adjustment factor #2 used. Analysis Date 09 - 21 - 2011/09:03:30 Residue file dated: 09 - 21 - 2011/09:00:33/8 Q* = 0.0149 COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic

=============================================================================== Critical Commodity Contribution Analysis for

U.S. Population (total) Total Exposure =.0001709 mg/kg bw/day Crop groups with total exposure contribution > 5% Foods/Foodforms with exposure contribution > 5%

----------------------------- -------------------------------------------------- Crop group ----------- Exposure analysis ---------- Food mg/kg | % of Total| Lifetime Risk Foodform body wt/day| Exposure |(Q*= .0149)

-------------------------------------- ----------- | ----------- | -------------- Crop Group = (O) Other Grape (95001750): FoodForm N/S 0.0000205 11.97% 3.05E - 07 Grape, juice (950 01760): FoodForm N/S 0.0000088 5.12% 1.31E - 07 Hop (95001880): FoodForm N/S 0.0000746 43.67% 1.11E - 06 Water, direct, all sources (86010000): FoodForm N/S 0.0000203 11.86% 3.02E - 07 Water, indirect, all sources (86020000): FoodForm N/S 0.0000149 8.74% 2.23E - 07

-------------------------------------- ----------- | - ---------- | -------------- Total for crop group 0.0001575 92.16% 2.35E - 06 Total for crop groups listed above: 0.0001575 92.16% 2.35E - 06

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