                                                
                          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                        WASHINGTON, D.C.  20460

                                                     OFFICE OF CHEMICAL SAFETY 
                                                       AND POLLUTION PREVENTION
                                                                               

MEMORANDUM  

Date:		15-October-2011

            Subject:	Spirodiclofen.  Dietary Risk Assessment in Support of the Requested use on Sugar Apple, Cherimoya, Atemoya, Custard Apple, Ilama, Soursop, Biriba, Lychee, Longan, Spanish Lime, Rambutan, Pulasan, Guava, Feijoa, Jaboticaba, Wax Jambu, Starfruit, Passionfruit, Persimmon, and Acerola.  

PC Code:  124871
DP Barcode:  D387338
Decision No.:  443557
Registration No.:  264-831
Petition No.:  0E7820
Regulatory Action:  Section 3 
Risk Assessment Type:  dietary
Case No.:  7443
TXR 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 (RAB1/HED; 7509P)

Through:		Kristin Rury, Biologist, RAB3/HED
		Julie Van Alstine, Environmental Health Scientist, RAB1/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, and grape (DEEM (ver 7.81) defaults assumed for the remaining processed commodities); (3) Biological and Economic Analysis Division (BEAD) 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 Analysis Modeling System (PRZM/EXAMS; citrus application scenario; 1 x 0.31 lb ai/acre; citrus yielded the highest chronic/cancer drinking water estimates).  The resulting 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 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).  

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 is referred to as the population-adjusted dose (PAD).  The PAD is equivalent to point of departure (POD; NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.  For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally 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 D371644 (T. Bloem, 28-Jul-2010).

II.	Residue Information

Residues of Concern in Plants 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 follows (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 residue 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 only 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 2510 are not available, then the dietary analysis should incorporate default processing factors.  Based on the results of the grape and orange processing studies, HED requested 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 these 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):  lychee - 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; cherimoya - 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; starfruit - 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 analyses incorporated the following:  (1) average field trial residues (see Table 2), (2) new use percent crop treated estimates for blueberry (2%) and hops (92% (see attachments 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, peach, 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 feedstuffs.  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 only), and almond hulls (dairy only)) are considered alternative feedstuffs and dietary burdens should include only one alternative feedstuff.  Of these three commodities, almond hulls and wet apple pomace yields the highest dietary burden estimates for dairy and beef cattle, respectively.  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 analysis, 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 ultimately 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 Estimates for the Chronic and Cancer Dietary Exposure Analyses.   
                                    Matrix
                Avg Fld Trl Res and Proj. Rumt, 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
-Apple and pear residues - D285249, T. Bloem, 18-Apr-2005.
-Apple processing study - D341847, T. Bloem, 25-Oct-2007; dried apple and apple juice processing factors translated to dried pear and pear juice.

pear[2] - 0.239
                                      10
dried pear - 0.18x; pear juice - 0.03x

citrus fruit
orange[2] - 0.104
                                      10
peeled fruit - 0.14x; juice - 0.06x; oil - 123x; peel - 2.2x
-Orange, lemon, and grapefruit residues - D285249, T. Bloem, 18-Apr-2005.
-Orange processing studies - 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



grapefruit[2] - 0.103
                                      50


tree nut
almond[2] - 0.023
                                       5
                                      --
-Almond 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.

plum[2] - 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.  
bushberry 13-07B
lowbush blueberry - 1.305
                                 blueberry - 2
                                      --
-Lowbush blueberry residue translated to the remaining members of the bushberry subgroup 13-07B (47886201.der.doc)
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 - 0.004
                                      --
                                      --


whole milk - 0.0002
                                      --
                                      --


milk fat - 0.005
                                      --
                                      --

[1]  See attachments 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
whole milk (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
whey[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
                                    0.00006
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

Surface and ground estimated drinking water concentrations were previously generated by the Environmental Fate and Effects Division (EFED) using PRZM-EXAMS and Screening Concentration in Ground Water Model (SCI-GROW), respectively (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-year peak concentration (23.86 ppb), 1-in-10-year yearly average (4.99 ppb), and 30-year 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 concluded 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 yearly average (4.99 ppb) and 30-year average (1.67 ppb), respectively.  

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 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, but for acute exposure assessment are retained as individual consumption events.  Based on analysis 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 year 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 subgroup.
IV.	Toxicological Information

Table 5 below summarizes the endpoints selected for dietary exposure analyses; for more detailed discussion on these endpoints see the HED risk assessment D386201 (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
cRfD = 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 Q1* (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 relevant human exposures.  NOAEL = no-observed adverse-effect level.  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 years 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
                                   0.000241
                                      1.7
All Infants (< 1 year old)

                                   0.000434
                                      3.1
Children 1-2 years old

                                   0.000444
                                      3.2
Children 3-5 years old

                                   0.000348
                                      2.5
Children 6-12 years old

                                   0.000193
                                      1.4
Youth 13-19 years old

                                   0.000136
                                      1.0
Adults 20-49 years old

                                   0.000268
                                      1.9
Adults 50+ years old

                                   0.000198
                                      1.4
Females 13-49 years old

                                   0.000183
                                      1.3
[1]  The bolded %cPAD represents the population with highest risk.

Table 7:  Summary of Cancer Dietary Exposure and Risk.
Population Subgroup
                                      Q1*
                             Exposure (mg/kg/day)
                                     Risk
General U.S. Population
                                    0.0149
                                   0.000171
                                 2.6 x 10[-6]

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) BEAD 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%; lemon - 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 analysis 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 is 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 analysis 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 analysis for hops and water:  (1) hops - DEEM-FCID assumes that 100% of the residue in hops are transferred to beer during the brewing process (no residues 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]).  
VII.	Conclusions

Chronic 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) BEAD 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 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 risk 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 Estimates (D387916, J. Alsadek).
            Attachment 2:	BEAD New Use Percent Crop Treated Estimates (D340691, J. Alsadek).
Attachment 3:	BEAD Spirodiclofen SLUA.
Attachment 4:	DEEM-FCID Chronic Residue File.
Attachment 5:	DEEM-FCID Chronic Exposure Estimates.
Attachment 6:	DEEM-FCID Cancer Residue File.
Attachment 7:	DEEM-FCID Cancer Exposure Estimates.
Attachment 8:	DEEM-FCID Critical Commodity Analysis for Cancer.

cc with all attachments:  B. Madden/Laura Nollen (RD; RM 05; 7505P)
T. Bloem:S10945:Potomac Yard 1:703-605-0217:7509P:RAB1
            Attachment 1:	BEAD New Use Percent Crop Treated Estimates  -  Blueberry (D387916, J. Alsadek).





              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460





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 Analysis Branch
		
		David W. Brassard, Senior Entomologist
		Biological Analysis Branch
		Biological and Economic Analysis Division (7503P)

THRU:	Diann Sims, Chief
		Science Information and Analysis Branch
		
		Arnet Jones, Chief
		Biological Analysis 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

 In this 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 described in the recommended Federal Register (FR) language, and an analysis of biological information describes relevant information that supports the likelihood that the PCTn estimates for spirodiclofen are not likely to be 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 reasonably 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 usage (i.e., the miticides with the greatest PCT) on that crop over the three most recent years 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 assessment is the maximum observed PCT over the same period, which in this case is 2%.  Comparisons are only 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 years.  

Typically, EPA uses USDA/National Agricultural Statistics Service (NASS) surveys as the source data because they are publicly 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 substantially similar.

A retrospective analysis to validate this approach shows few cases where the PCT for the highest miticides were exceeded, (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 pest 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 resistance issues with past miticides provide spirodiclofen with significant market potential.  Given currently 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 analysis, 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 currently 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 market to assign a conservative upper bound PCT value for the new use.  

The market leader approach is backed by an analysis conducted by 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 this analysis, 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 by dividing the base area treated (the area treated at least one time by a given pesticide) by the crop acres grown and multiplying the value by 100.  The miticide with the highest PCT for each data year was designated as the market leader and the PCT values 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 by 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 Blueberries
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
2

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 use; 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 of FIFRA are a good indicator in regard to these situations.  On the other hand, it would be relatively 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.  Finally, if the target pests are developing 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 mite, and grape erineum mite. Spirodiclofen displays contact activity to mite eggs, all nymphal stages, and adult females (adult males are not affected).   Spirodiclofen also suppresses San Jose scales.

Spirodiclofen is currently registered for use on avocado, Christmas trees, citrus crops, grapes, papaya, pome fruits, stone fruits, and tree nuts.

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

   oo 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 blueberries (NPIRS 2011).

   oo 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 information 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 Blueberry 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://quickstats.nass.usda.gov/results/1B5A8EE8-DD63-337C-BF3C-62B4038A8B3F#0484BA58-FC01-3CF4-AC4B-9314BAF11D08  
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
Pyridaben
Fenpropathrin/Formetanate 
Pyridaben 
                                      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 2006
Attachment 3:  BEAD Spirodiclofen SLUA.





Attachment 4:  DEEM-FCID Chronic Residue File.

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   Orange, 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  
11000080 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   Cherry, 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  0.050  
12002610 12   Peach, dried                       0.368000   7.000  0.050  
12002611 12   Peach, dried-babyfood              0.368000   7.000  0.050  
12002620 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   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  
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  
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 byproducts              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    Sheep, 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  
27012230 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/infant form   0.000200   1.000  1.000  
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    Lychee                             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  
95002450 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  1.000  
Attachment 5:  DEEM-FCID Chronic Exposure Estimates.

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: 09-21-2011/08:59:51/8
Reference dose (RfD, Chronic) = .014 mg/kg bw/day
COMMENT 1: no acute endpoint identified; 100x uncertainity factor for chronic
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------
                                                   Total Exposure
                                         -----------------------------------
          Population                         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                               0.000301                 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%

-------------------------------------------------------------------------------
Attachment 6:  DEEM-FCID Cancer Residue File.

Filename: C:\Documents 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: 09-21-2011/09:00:33/8          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  1.000  
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   Orange, 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  
11000080 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   Cherry, 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  0.050  
12002610 12   Peach, dried                       0.368000   7.000  0.050  
12002611 12   Peach, dried-babyfood              0.368000   7.000  0.050  
12002620 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   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  
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  
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 byproducts              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    Sheep, 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  
27012230 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/infant form   0.000200   1.000  1.000  
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    Lychee                             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  
95002450 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  1.000  
Attachment 7:  DEEM-FCID Cancer Exposure Estimates.

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* = 0.0149 
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

-------------------------------------------------------------------------------
Attachment 8:  DEEM-FCID Critical Commodity Analysis for Cancer.

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 (95001760):
        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
-------------------------------------------------------------------------------

