Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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, 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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/EPAPEST/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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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-OHenol. 

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 Fruit1

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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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 

Estimates1

Processing Factors Crop Translation and/or Comments

pome fruit

apple2- 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 

pear dried pear and pear juice. 2- 0.239 10

dried pear - 0.18x; pear juice 

- 0.03x

citrus fruit

orange2- 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. 

lemon2- 0.121 1

grapefruit2- 0.103 50

tree nut

almond2- 0.023 5 --

-Almond and pecan residues -D285249, T. Bloem, 18-Apr2005.

pecan2-0.019 2 --

filbert - 0.019 2 --

pistachio - 0.023 1 --

walnut - 0.019 5 --

stone fruit

peach2- 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)

cherry2- 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-Jun2002). 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)
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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 

Estimates1

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 - 0.004 -- --

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 Matter1 % Diet1 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 

Spirodiclofen BAJ 2510 Total 0.40 ppm dietary burden

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

whey2

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
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Table 4: Summary of Cattle Feeding Study and Projected Residue.

Dose; ppm (DBx) Residue (ppm) Projected Residue Assuming a 

Spirodiclofen BAJ 2510 Total 0.40 ppm dietary burden

cream2

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-Jan2005). 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 PRZMEXAMS (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 foodform (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.
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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) %cPAD1

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
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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) 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 - DEEMFCID 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). 
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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
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

Attachment 1: BEAD New Use Percent Crop Treated Estimates – 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 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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

Page 11 of 26

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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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

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 

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
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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.

 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 blueberries (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 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-BF3C62B4038A8B3F#0484BA58-FC01-3CF4-AC4B-9314BAF11D08 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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. 

Year ML Avg. PCT/Acute

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
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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Attachment 3: BEAD Spirodiclofen SLUA.
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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Spirodiclofen Dietary Exposure and Risk Assessment D387338

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Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

Page 21 of 26

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%

-------------------------------------------------------------------------------
Spirodiclofen Dietary Exposure and Risk Assessment D387338

Page 22 of 26

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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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 
Spirodiclofen Dietary Exposure and Risk Assessment D387338

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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

-------------------------------------------------------------------------------
Spirodiclofen Dietary Exposure and Risk Assessment D387338

Page 26 of 26

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

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