Document ID: EPA-HQ-OPP-2007-0398-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-05-07T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM  

Date:  3-JAN-2008

Subject:	PP#:  7E7204.  Spirodiclofen - Chronic and Cancer Aggregate
Dietary Exposure and Risk Assessments for the Section 3 Registration
Request for Hops.  

PC Code: 124871.  DP#: D346757.  Decision#: 378132

Reviewer:  	Mohsen Sahafeyan, Chemist

Registration Action Branch 1/Health Effects Division (RAB1/HED; 7509P)

Through:	George F. Kramer, Ph.D., Senior Chemist

		RAB1/HED (7509P)

			And

		David Soderberg, Chemist

		Toiya Goodlow, Chemist

Dietary Exposure Science Advisory Council (DESAC)

HED (7509P)

To:		Mary Clock-Rust, Biologist

RAB1/HED (7509P)

Executive Summary

Aggregate (food + water) chronic and cancer dietary risk assessments
were conducted using the Dietary Exposure Evaluation Model - Food
Consumption Intake Database (DEEM-FCID(, ver. 2.03) in support of
Section 3 registration of acaricide spirodiclofen,
3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl
2,2-dimethylbutanoate on hops.  These assessments update the previously
conducted dietary risk analyses (T. Bloem, D315255, 18-Apr-2005).  The
changes made to those analyses include addition of the new requested use
(hops), modification of the processing factors for apples and grapes
based on the review of the new submissions (T. Bloem, D341847,
25-Oct-2007), more recent projected average percent crop treated (%CT)
estimates and using the new no-observed adverse-effect level (NOAEL) for
chronic population adjusted dose (cPAD) (0.014 mg/kg/day instead of
0.0065 mg/kg/day).  DEEM-FCID uses food consumption data from the
USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII;
1994-1996 and 1998).  Acute dietary risk assessment was not conducted
since an appropriate endpoint attributable to a single dose was not
identified for U.S. general population and its population subgroups.

The chronic and cancer analyses incorporated average field trial
residues, experimental and DEEM default processing factors, and
projected average %CT estimates and drinking water estimates using
Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
model.  

The resulting chronic (food + water) exposure estimates were not of
concern to HED [<100% of the chronic population adjusted dose (cPAD)]
for U.S. general population (1.8 % cPAD) and all population sub-groups;
the most highly exposed population subgroup was all infants (<1 year
old) with 3.2% cPAD.  

The cancer risk estimate (food + water) for the U.S. population was 3 x
10-6 for the general U.S. population, which is not considered to be
exceeding HED’s level of concern (see discussion section for more
details); HED generally conducts cancer dietary risk for U.S. general
population only.  Hops, water, and orange juice were major contributors
to the cancer risk. 

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:      HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf" 
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 was conducted
by Tom Bloem (D315255, 18-Apr-2005).

II.	Residue Information

Residues of Concern in Plants and Livestock:  Table 1 is a summary of
the conclusion made by HED concerning the residues of concern in plant,
livestock, and drinking water (Risk Assessment Documents, D285047 and
D341847).   

Table 1.  Residues for Tolerance Expression and Risk Assessment.

Matrix	

Residues included in Risk Assessment	

Residues included in Tolerance Expression

Citrus fruit, Pome Fruit, Stone Fruit, Tree Nut 1	

spirodiclofen	

spirodiclofen

Grape1	

spirodiclofen	

spirodiclofen, BAJ 2510

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	See reference: T. Bloem, D341847, 25-Oct-2007.   

Established/Recommended Tolerances:  The current petition is for hops
(maximum 0.39 lb ai/A with 14 day PHI) with no associated feed crops. 
HED also reviewed the documents submitted by the registrant addressing
the previously identified deficiencies recently (T. Bloem, D341847,
25-Oct-2007).  Based on the review of the residue chemistry data
associated with the current petition (M. Sahafeyan, D339672), HED is
recommending for establishment of a tolerance on hops at 30 ppm. 
Tolerances for spirodiclofen are listed in 40 CFR § 180.608.  Table 2
contains established/recommended tolerances for all spirodiclofen uses
(livestock tolerances for spirodiclofen and BAJ 2150).

Table 2.  Recommended Tolerances.

Commodity	

Established/Recommended Tolerance (ppm)1

grape	

2.0

grape, raisin	

4.0

grape, juice	

2.4

fruit, citrus, crop group 10	

0.50

citrus, oil	

20

citrus, juice	

0.60

fruit, pome, crop group 11	

0.80

apple, wet pomace	

2.0

fruit, stone, crop group 12	

1.0

nut, tree, crop group 14	

0.10

almond, hulls	

20

pistachio	

0.10

hops	30

cattle, fat	

0.02

cattle, meat byproducts	

0.10

cattle, meat	

0.02

goat, fat	

0.02

goat, meat byproducts	

0.10

1	Plant tolerances for residues of spirodiclofen
(3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl
2,2-dimethylbutanoate) and livestock tolerances for residues of 
spirodiclofen and BAJ 2510
(3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one).

Plant Residues Used in the Chronic/Cancer Risk Assessments:  The chronic
and cancer dietary analyses incorporated projected average percent crop
treated estimates (see attachment 1), average field trial residues (see
Table 3), and experimentally determined processing factors when
available (see Table 3).  The HED Chemistry Science Advisory Committee
(ChemSAC) expressed concern that spirodiclofen may be
hydrolyzing/degrading to BAJ 2510, 3-OH-enol, and/or 4-OH-enol during
processing procedures that involve high temperatures (i.e.
pasteurization).  Recently submitted and reviewed apple and grape
processing studies (T. Bloem, D341847, 25-Oct-2007) showed new
processing factors for apples and grapes processed commodities and also
demonstrated degradation of spirodiclofen to BAJ 2510 in grapes
processing commodities; the new processing factors for apple and grape
are used in this dietary exposure analyses.  HED is requesting that the
petitioner submit an orange processing study monitoring for residues of
spirodiclofen, BAJ 2510, 3-OH-enol, and 4-OH-enol.  Pending the
submission of these data, human-health risk assessments should assume
default processing factors for all processed commodities excluding the
processed commodities for apple and grape.    

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 was calculated for ruminants in the
previous dietary risk assessment (T. Bloem, D315255, 18-Apr-2005) and
were also used in the current analyses; see Tables 4 and 5.

Table 3.  Summary of Average Crop Residues, Crop Processing Factors,
Average Projected Percent Crop Treated Estimates, and Projected Ruminant
Residues used in the Chronic and Cancer Dietary Exposure Analyses.   

Matrix	

Avg Fld Trl Res and Projected Ruminant Residues (ppm)	

Average % Crop Treated Estimates1	

Processing Factors	

Crop Translation and/or Comments

pome fruit	

apple - 0.146	

15	

apple sauce (0.07x)2, dried apple (0.18x)2;

peeled apple (0.15x)	

apple RAC residue translated to crabapple and pear RAC residue
translated to loquat, mayhaw, Oriental pear, and quince3.

dried apple and apple juice processing factors were translated to dried
pear and pear juice respectively.

per the suggestion of BEAD, the 15% projected average apple percent crop
treated estimate was translated to all crops in the pome fruit crop
group.

	

apple juice - 0.102	

15	

juice (0.03x)4

pear - 0.239	

15	

dried pear (0.18x); 

pear juice (0.03x);

	

citrus fruit	

orange - 0.104	

14 (except temple)	

peeled fruit (0.06x)2, juice (1.8x)4, oil (69x)2, peel (1.2x)2	

orange RAC residue translated to calamondin, citron, citrus hybrids
(tangelo), kumquat, mandarin, and tangerine (tangerine juice processing
factor of 2.3x4); lemon RAC residue translated to lime (juice processing
factor of 2.0x4) and citrus oil (69x2); and grapefruit RAC residue
translated to pummelo3.

per the suggestion of BEAD the orange peeled fruit processing factor was
translated to all citrus RACs.

per the suggestion of BEAD, orange %CT data was translated to all citrus
except grapefruit (see attachment 1).

	

lemon - 0.121	

14	

juice (2.0x)4, peeled fruit (0.06x), peel (1.2x)2, oil (69x) 2

grapefruit - 0.103

	

13

	

juice (2.1x)4, peeled fruit (0.06x

	

tree nut	

almond - 0.023	

100	

--	

almond RAC residue translated to beech nut, chestnut, chinquapin, and
pistachio and pecan RAC residue translated to brazil nut, butternut,
cashew, filbert, hickory nut, macadamia nut, and walnut3.

	

pecan -0.019	

100	

--

	

stone fruit	

peach - 0.368	

10	

dried peach (7.0x)4	

peach RAC residue translated to apricot (dried apricot processing factor
of 6.0)4 and nectarine and plum RAC residue translated to chickasaw
plum, damson plum, Japanese plum, plumcot, and fresh prune3.

per the suggestion of BEAD, the 10% projected average peach percent crop
treated estimate was translated to all crops in the stone fruit crop
group.

	

plum - 0.068	

10	

prune fresh (2.5x)2, prune dried (5.0x)4, prune juice (1.4x)4

cherry - 0.286	

10	

juice (1.5x)4

	

grape	

grape - 0.697	

7	

raisin (4.3x)2	- New experimental processing factor was determined for
juice.

	

grape juice - 0.488	

7	

juice (0.17x)4

	hop	hop -  11.6	92	--	- average residue from German field trial data
with 14-day PHI.

cattle, goat, sheep, horse	

liver - 0.0009	

--	

--	

-  see Tables 4 and 5.

residue in meat byproducts translated from fat.

since spirodiclofen may concentrate in milk fat (Kow=5.83), residues in
milk fat were estimated using the 25x milk fat concentration factor
(0.0002 ppm x 25 = 0.005 ppm).

	

kidney - 0.004	

--	

--

muscle - 0.0001	

--	

dried beef (1.92x)4

fat - 0.0007	

--	

--

meat bypdcts - 0.0007	

--	

--

whole milk - 0.0002	

--	

--

milk fat - 0.005	

--	

--

	1	See attachment 1.

2	Experimentally determined processing factors;  apple:
47168602.der.doc; grape: 47168601.der.doc (also see: T. Bloem, D341847,
25-Oct-2007); citrus: 45696516.der.wpd; plum - 45696520.der.wpd.

3	HED SOP 2000.1; Guidance for Translation of Field Trial Data from Rep.
Comm. in the Crop Group Regulation to Other Commodities in Each Crop
Group/Subgroup.

4	DEEM (ver. 7.76) default processing factor.

Table 4.	 Calculation of Spirodiclofen Dietary Brudens.

Feed Commodity	

% Dry Matter1	

% Diet2	

Average Residue (ppm)3	

Dietary Contribution (ppm)4

Beef Cattle

dried citrus pulp	

91	

5	

0.16	

0.01

almond hull	

90	

5	

7.20	

0.40

MTDB	

--	

10	

--	

0.41

Diary Cattle

dried citrus pulp	

91	

5	

0.16	

0.01

almond hull	

90	

5	

7.20	

0.40

MTDB	

--	

10	

--	

0.41

1	OPPTS 860.1000 Table 1 (August 1996).

2	Comments from J. Stokes; see previous dietary risk memorandum (T.
Bloem, D315255, 18-Apr-2005).

3	Average almond hull field trial residue; average citrus field trial
residue (0.121 ppm from lemon) multiplied by the 1.3x dried citrus pulp
processing factor.

4	Dietary contribution = tolerance ( % dry matter x % diet.

Table 5.	 Summary of Cattle Feeding Study and Projected Residue.

Dose; ppm (MTDBx)	

Residue (ppm)	

Projected Residue Assuming  a 0.41 ppm dietary burden

	

Spirodiclofen	

BAJ 2510	

Total

	

liver

1.38 (3.4x)	

not analyzed

4.12 (10.0x)	

not analyzed

13.75 (33.5x)	

<0.01	

0.01-0.02	

<0.02-<0.03	

0.0009

kidney

1.38 (3.4x)	

not analyzed

4.12 (10.0x)	

<0.01	

<0.01-0.03	

<0.01-<0.04	

0.004

13.75 (33.5x)	

<0.01	

0.04-0.09	

<0.05-<0.10	

0.003

muscle

1.38 (3.4x)	

not analyzed

4.12 (10.0x)	

not analyzed

13.75 (33.5x)	

<0.002	

<0.002	

<0.004	

0.0001

fat

1.38 (3.4x)	

not analyzed

4.12 (10.0x)	

<0.002	

<0.002	

<0.004	

0.0004

13.75 (33.5x)	

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 (10.0x)	

not analyzed

13.75 (33.5x)	

<0.001-0.003	

<0.001-0.003	

<0.002-0.006	

0.0002

whey2

1.38 (3.4x)	

not analyzed

4.12 (10.0x)	

not analyzed

13.75 (33.5x)	

<0.001	

<0.001-0.001	

<0.002	

0.00006

cream2

1.38 (3.4x)	

not analyzed

4.12 (10.0x)	

not analyzed

13.75 (33.5x)	

0.005-0.012	

<0.002- 0.002	

<0.008- <0.014	

0.0004

1	In milk collected from animals dosed at 6.2x, 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 6.2x with combined
residues of 0.004 ppm was processed into whey and cream.

III.  Drinking Water Data

The recent memorandum from Environmental Fate and Effects Division
(EFED) (L. Liu, D339673 and D337172, 10/18/07), stated that the
previously generated residue data using the PRZM-EXAMS and Screening
Concentration In Ground Water (SCI-GROW) models (D311291, F. Khan,
4-Jan-2005) can be used for the current uses.

Surface and ground estimated drinking water concentrations were
generated using the PRZM-EXAMS and SCI-GROW models, respectively.  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 the PRZM-EXAMS (citrus, pecan, apple,
peach, and grape; 87% crop treated assumed) with citrus 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).  Therefore, the
citrus distribution is considered to be the most conservative.  The
citrus PRZM-EXAMS 1-in-10-year yearly average and 30-year average were
used for the chronic and cancer analyses, respectively (these point
estimates are greater than the ground water estimate and therefore more
conservative).  

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.

For acute exposure assessments, individual one-day food consumption data
are used on an individual-by-individual basis.  The reported consumption
amounts of each food item can be multiplied by a residue point estimate
and summed to obtain a total daily pesticide exposure for a
deterministic exposure assessment, or “matched” in multiple random
pairings with residue values and then summed in a probabilistic
assessment.  The resulting distribution of exposures is expressed as a
percentage of the aPAD on both a user (i.e., those who reported eating
relevant commodities/food forms) and a per-capita (i.e., those who
reported eating the relevant commodities as well as those who did not)
basis.  In accordance with HED policy, per capita exposure and risk are
reported for all tiers of analysis.  However, for Tiers 1 and 2,
significant differences in user vs. per capita exposure and risk are
identified and noted in the risk assessment.

IV.	Toxicological Information

The risk assessment team in November 2007 (D339672) reevaluated the
chronic dietary endpoint based on the recently submitted toxicological
studies.  Table 6 below summarizes the selected endpoints and rational;
for more detailed discussion on endpoints see the previous dietary risk
assessment (T. Bloem, D315255, 18-Apr-2005).

Table 6  Summary of Toxicological Doses and Endpoints for Spirodiclofen
for Use in Dietary Exposure Risk Assessments.

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

mg/kg/day	UF = 100

FQPA SF= [1]x

	Chronic RfD = 

0.014 mg/kg/day 

cPAD = [0.014 ] mg/kg/day	Chronic Oral Toxicity Study in Dogs

LOAEL= 4.7 mg/kg/day based on increased relative adrenal weights in both
sexes, increased relative testis weight in males and histopathology
findings in the adrenal gland of both sexes.

Cancer 	

Classification: “Likely to be Carcinogenic to Humans” with 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

For chronic dietary risk assessments, HED is concerned when dietary risk
exceeds 100% of cPAD.  Cancer risks are expressed to one significant
figure to allow better characterization of changes in risk which might
result from potential risk mitigation.  Also, the risk should generally
not be assumed to exceed the benchmark level of concern of 10-6 until
the calculated risks exceed approximately 3 x 10-6.  Calculated risks
ranging from approximately 3 x10-x-13 to 3 x 10-x (e.g., 3 x 10-7 to 3 x
10-6) are indistinguishable from 10-x (e.g., 10-6).  Therefore, risks
should not be identified as exceeding the benchmark level of concern of
10-6 until the calculated risks exceed approximately 3 x 10-6.  HED
performs cancer analyses for only the general U.S. population.  The
results are summarized in Tables 7 and 8 below for chronic and cancer
analyses, respectively.  

The resulting chronic (food + water) exposure estimates were not of
concern to HED (<100% of the cPAD) for U.S. general population (1.8 %
cPAD) and all population sub-groups; the most highly exposed population
subgroup was all infants (<1 year old) with 3.2% cPAD.

The cancer risk estimates for the U.S. general population with and
without water were 3 x 10-6 and 2 x 10-6 respectively which are not
considered to be exceeding HED’s level of concern.  HED also notes
that the cancer risk estimates were generated using average residues
derived from crop field trial studies (maximum application rate and
minimum preharvest interval), incorporated maximum theoretical
processing factors for juice, and incorporated surface drinking water
estimates which assumed 87% of the basin was cropped and 100% of the
cropped area was treated at the maximum rate.  Based on a critical
commodity analysis conducted in DEEM-FCID(, the major contributors to
the cancer risk were hops (41% of the total exposure), water (19% of the
total exposure), and orange juice (17% of the total exposure).

Table 7.	Summary of Chronic Dietary Exposure and Risk for Spirodiclofen
(drinking water included).

Population Subgroup	

cPAD (mg/kg/day)	

Exposure (mg/kg/day)	

%cPAD

General U.S. Population	

0.014	

0.000253	1.8

All Infants (< 1 year old)

0.000452	3.2

Children 1-2 years old

0.000424	3.0

Children 3-5 years old

0.000345	2.5

Children 6-12 years old

0.000210	1.5

Youth 13-19 years old

0.000160	1.1

Females 13-49 years old

0.000197	1.4

Adults 20-49 years old

0.000280	2.0

Adults 50+ years old

0.000211	1.5

The bolded %cPAD is the highest.

Table 8.  Summary of Cancer Dietary Exposure and Risk for Spirodiclofen.

Population Subgroup	Q1*	Exposure (mg/kg/day)	Risk

with drinking water

General U.S. Population	0.0149	0.000183	3 x 10-6

without drinking water

General U.S. Population	0.0149	0.000148	2 x 10-6

VI.	Characterization of Inputs/Outputs

The chronic and cancer analyses were refined through the use of average
field trial residues, experimentally determined processing factors, and
BEAD projected average percent crop treated estimates.  BEAD provided
projected average percent crop treated estimates for apple, peach,
grape, orange, and grapefruit (see attachment 1).  These averages were
based on the typical average of all insecticides used to control all
pests on the specific crop.  In response to an HED inquiry, BEAD
indicated that it is appropriate to translate the projected percent crop
treated estimates for peach, apple, and orange to the remaining crops in
the stone fruit, pome fruit, and citrus crop groups, respectively.  

Since the analysis made use of average residues derived from crop field
trial studies (maximum application rate and minimum preharvest
interval), incorporated maximum theoretical processing factors for
juice, and incorporated surface drinking water estimates which assumed
87% of the basin was cropped and 100% of the cropped are was treated at
the maximum rate, HED concludes that the exposure estimates provided in
this document are unlikely to underestimate actual exposure.

Based on a critical commodity analysis conducted in DEEM-FCID(, the
major contributors to the cancer risk were hops (41% of the total
exposure), water (19% of the total exposure), and orange juice (17% of
the total exposure).

 VII.	Conclusions

Aggregate (food + water) chronic and cancer dietary risk analyses for
spirodiclofen were updated using DEEM-FCID to support the Section 3
registration of spirodiclofen on hops.  Other modifications to the
previous dietary risk analyses include using new processing factors for
apples and grapes based on the review of the new submissions, more
recent projected average %CT estimates and using the new chronic dietary
endpoint (0.014 mg/kg/day instead of 0.0065 mg/kg/day).  These analyses
are considered conservative since they used (average) field trial
residues, average model-generated residues in drinking water using
worst-case scenario and conservative default processing factors for most
commodities.  The resulting chronic (food + water) exposure estimates
were not of HED concern; the most highly exposed population subgroup was
all infants (<1 year old) with 3.2% cPAD.  The cancer risk estimates for
the U.S. population with drinking water included was 3 x 10-6 and
therefore, the cancer risk is not of concern.  Hop, water, and orange
with 41%, 19%, and 17% of the exposure, respectively, were the major
contributors to the cancer risk.

VIII.		List of Attachments

Attachment 1:	BEAD Projected Percent Crop Treated Estimates

Attachment 2:	DEEM-FCID( chronic (food + water) residue file	

Attachment 3:	DEEM-FCID( chronic (food + water) exposure estimates 

Attachment 4:	DEEM-FCID( cancer (food + water) residue file

Attachment 5:	DEEM-FCID( cancer exposure estimates with and without
drinking water

Attachment 6:	DEEM-FCID( critical commodity analysis for cancer

cc with all attachments:  M. Sahafeyan (RAB1)

RDI: DESAC (19-NOV-2007)

Petition Number(s): PP#7E7204

DP#: 346757

PC Code: 124871

M. Sahafeyan:S10944:PY1:(703)-305-0776

Attachment 1:  BEAD Projected Percent Crop Treated Estimates			

(J. Alsadek, DP # 340691, August 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

Note: Average %CT of 13% for grapefruit, based on its use in 2005 was
recommended by J. Alsadek (personal communication, 11/20/07)	

Attachment 2:  DEEM-FCID( chronic residue file (food + water).

Filename: C:\Documents and Settings\msahafey\My
Documents\spirodiclofen\124871 chronic with water-122007.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: 12-20-2007/13:02:51/8          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   

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

14000030 14   Almond                             0.023000   1.000  1.000
 

14000031 14   Almond-babyfood                    0.023000   1.000  1.000
 

14000040 14   Almond, oil                        0.023000   1.000  1.000
 

14000041 14   Almond, oil-babyfood               0.023000   1.000  1.000
 

11000070 11   Apple, fruit with peel             0.146000   1.000  0.150
 

11000080 11   Apple, peeled fruit                0.146000   0.150  0.150
 

11000081 11   Apple, peeled fruit-babyfood       0.146000   0.150  0.150
 

11000090 11   Apple, dried                       0.146000   0.180  0.150
 

11000091 11   Apple, dried-babyfood              0.146000   0.180  0.150
 

11000100 11   Apple, juice                       0.146000   0.030  0.150
 

11000101 11   Apple, juice-babyfood              0.146000   0.030  0.150
 

11000110 11   Apple, sauce                       0.146000   0.070  0.150
 

11000111 11   Apple, sauce-babyfood              0.146000   0.070  0.150
 

12000120 12   Apricot                            0.368000   1.000  0.100
 

12000121 12   Apricot-babyfood                   0.368000   1.000  0.100
 

12000130 12   Apricot, dried                     0.368000   6.000  0.100
 

12000140 12   Apricot, juice                     0.368000   1.000  0.100
 

12000141 12   Apricot, juice-babyfood            0.368000   1.000  0.100
 

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              0.000700   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.000700   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
 

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
 

12000900 12   Cherry                             0.286000   1.000  0.100
 

12000901 12   Cherry-babyfood                    0.286000   1.000  0.100
 

12000910 12   Cherry, juice                      0.286000   1.500  0.100
 

12000911 12   Cherry, juice-babyfood             0.286000   1.500  0.100
 

14000920 14   Chestnut                           0.023000   1.000  1.000
 

10001060 10   Citrus citron                      0.104000   1.000  0.140
 

10001070 10   Citrus hybrids                     0.104000   0.060  0.140
 

10001080 10   Citrus, oil                        0.121000  69.000  0.140
 

11001290 11   Crabapple                          0.146000   1.000  0.150
 

14001550 14   Filbert                            0.019000   1.000  1.000
 

14001560 14   Filbert, oil                       0.019000   1.000  1.000
 

23001690 M    Goat, meat                         0.000100   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.000700   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
 

95001750 O    Grape                              0.697000   1.000  0.070
 

95001760 O    Grape, juice                       0.697000   0.170  0.070
 

95001761 O    Grape, juice-babyfood              0.697000   0.170  0.070
 

95001770 O    Grape, leaves                      0.697000   1.000  0.070
 

95001780 O    Grape, raisin                      0.697000   4.300  0.070
 

95001790 O    Grape, wine and sherry             0.697000   1.000  0.070
 

10001800 10   Grapefruit                         0.103000   0.060  0.130
 

10001810 10   Grapefruit, juice                  0.103000   2.100  0.130
 

14001850 14   Hickory nut                        0.019000   1.000  1.000
 

95001880 O    Hop                               11.600000   1.000  0.920
 

24001890 M    Horse, meat                        0.000100   1.000  1.000
 

10001970 10   Kumquat                            0.104000   0.060  0.140
 

10001990 10   Lemon                              0.121000   0.060  0.140
 

10002000 10   Lemon, juice                       0.121000   2.000  0.140
 

10002001 10   Lemon, juice-babyfood              0.121000   2.000  0.140
 

10002010 10   Lemon, peel                        0.121000   1.200  0.140
 

10002060 10   Lime                               0.121000   0.060  0.140
 

10002070 10   Lime, juice                        0.121000   2.000  0.140
 

10002071 10   Lime, juice-babyfood               0.121000   2.000  0.140
 

11002100 11   Loquat                             0.239000   1.000  0.150
 

14002130 14   Macadamia nut                      0.019000   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
 

12002300 12   Nectarine                          0.368000   1.000  0.100
 

10002400 10   Orange                             0.104000   0.060  0.140
 

10002410 10   Orange, juice                      0.104000   1.800  0.140
 

10002411 10   Orange, juice-babyfood             0.104000   1.800  0.140
 

10002420 10   Orange, peel                       0.104000   1.200  0.140
 

12002600 12   Peach                              0.368000   1.000  0.100
 

12002601 12   Peach-babyfood                     0.368000   1.000  0.100
 

12002610 12   Peach, dried                       0.368000   7.000  0.100
 

12002611 12   Peach, dried-babyfood              0.368000   7.000  0.100
 

12002620 12   Peach, juice                       0.368000   1.000  0.100
 

12002621 12   Peach, juice-babyfood              0.368000   1.000  0.100
 

11002660 11   Pear                               0.239000   1.000  0.150
 

11002661 11   Pear-babyfood                      0.239000   1.000  0.150
 

11002670 11   Pear, dried                        0.239000   0.180  0.150
 

11002680 11   Pear, juice                        0.239000   0.030  0.150
 

11002681 11   Pear, juice-babyfood               0.239000   0.030  0.150
 

14002690 14   Pecan                              0.019000   1.000  1.000
 

14002820 14   Pistachio                          0.023000   1.000  1.000
 

12002850 12   Plum                               0.068000   1.000  0.100
 

12002851 12   Plum-babyfood                      0.068000   1.000  0.100
 

12002860 12   Plum, prune, fresh                 0.068000   2.500  0.100
 

12002861 12   Plum, prune, fresh-babyfood        0.068000   2.500  0.100
 

12002870 12   Plum, prune, dried                 0.068000   5.000  0.100
 

12002871 12   Plum, prune, dried-babyfood        0.068000   5.000  0.100
 

12002880 12   Plum, prune, juice                 0.068000   1.400  0.100
 

12002881 12   Plum, prune, juice-babyfood        0.068000   1.400  0.100
 

10003070 10   Pummelo                            0.103000   0.060  0.140
 

11003100 11   Quince                             0.239000   1.000  0.150
 

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             0.000700   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
 

10003690 10   Tangerine                          0.104000   0.060  0.140
 

10003700 10   Tangerine, juice                   0.104000   2.300  0.140
 

14003910 14   Walnut                             0.019000   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
 

Attachment 3:  DEEM-FCID( chronic (food + Water) 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\msahafey\My
Documents\spirodiclofen\124871 chronic with water-122007.R98

                                                     Adjustment factor
#2 used.

Analysis Date 12-20-2007/13:14:19     Residue file dated:
12-20-2007/13:02:51/8

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)                     0.000253                
1.8%

U.S. Population (spring season)             0.000267                
1.9%

U.S. Population (summer season)             0.000271                
1.9%

U.S. Population (autumn season)             0.000237                
1.7%

U.S. Population (winter season)             0.000238                
1.7%

Northeast region                            0.000247                
1.8%

Midwest region                              0.000262                
1.9%

Southern region                             0.000228                
1.6%

Western region                              0.000290                
2.1%

Hispanics                                   0.000263                
1.9%

Non-hispanic whites                         0.000258                
1.8%

Non-hispanic blacks                         0.000217                
1.6%

Non-hisp/non-white/non-black                0.000261                
1.9%

All infants (< 1 year)                      0.000452                
3.2%

Nursing infants                             0.000191                
1.4%

Non-nursing infants                         0.000551                
3.9%

Children 1-6  yrs                           0.000360                
2.6%

Children 7-12 yrs                           0.000197                
1.4%

Females 13-19 (not preg or nursing)         0.000139                
1.0%

Females 20+ (not preg or nursing)           0.000202                
1.4%

Females 13-50 yrs                           0.000210                
1.5%

Females 13+ (preg/not nursing)              0.000165                
1.2%

Females 13+ (nursing)                       0.000226                
1.6%

Males 13-19 yrs                             0.000180                
1.3%

Males 20+ yrs                               0.000313                
2.2%

Seniors 55+                                 0.000202                
1.4%

Children 1-2 yrs                            0.000424                
3.0%

Children 3-5 yrs                            0.000345                
2.5%

Children 6-12 yrs                           0.000210                
1.5%

Youth 13-19 yrs                             0.000160                
1.1%

Adults 20-49 yrs                            0.000280                
2.0%

Adults 50+ yrs                              0.000211                
1.5%

Females 13-49 yrs                           0.000197                
1.4%

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

Attachment 4:  DEEM-FCID( cancer residue file (food + water).

Filename: C:\Documents and Settings\msahafey\My
Documents\spirodiclofen\124871-cancer with water-122007.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: 12-20-2007/13:07:51/8          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   

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

14000030 14   Almond                             0.023000   1.000  1.000
 

14000031 14   Almond-babyfood                    0.023000   1.000  1.000
 

14000040 14   Almond, oil                        0.023000   1.000  1.000
 

14000041 14   Almond, oil-babyfood               0.023000   1.000  1.000
 

11000070 11   Apple, fruit with peel             0.146000   1.000  0.150
 

11000080 11   Apple, peeled fruit                0.146000   0.150  0.150
 

11000081 11   Apple, peeled fruit-babyfood       0.146000   0.150  0.150
 

11000090 11   Apple, dried                       0.146000   0.180  0.150
 

11000091 11   Apple, dried-babyfood              0.146000   0.180  0.150
 

11000100 11   Apple, juice                       0.146000   0.030  0.150
 

11000101 11   Apple, juice-babyfood              0.146000   0.030  0.150
 

11000110 11   Apple, sauce                       0.146000   0.070  0.150
 

11000111 11   Apple, sauce-babyfood              0.146000   0.070  0.150
 

12000120 12   Apricot                            0.368000   1.000  0.100
 

12000121 12   Apricot-babyfood                   0.368000   1.000  0.100
 

12000130 12   Apricot, dried                     0.368000   6.000  0.100
 

12000140 12   Apricot, juice                     0.368000   1.000  0.100
 

12000141 12   Apricot, juice-babyfood            0.368000   1.000  0.100
 

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              0.000700   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.000700   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
 

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
 

12000900 12   Cherry                             0.286000   1.000  0.100
 

12000901 12   Cherry-babyfood                    0.286000   1.000  0.100
 

12000910 12   Cherry, juice                      0.286000   1.500  0.100
 

12000911 12   Cherry, juice-babyfood             0.286000   1.500  0.100
 

14000920 14   Chestnut                           0.023000   1.000  1.000
 

10001060 10   Citrus citron                      0.104000   1.000  0.140
 

10001070 10   Citrus hybrids                     0.104000   0.060  0.140
 

10001080 10   Citrus, oil                        0.121000  69.000  0.140
 

11001290 11   Crabapple                          0.146000   1.000  0.150
 

14001550 14   Filbert                            0.019000   1.000  1.000
 

14001560 14   Filbert, oil                       0.019000   1.000  1.000
 

23001690 M    Goat, meat                         0.000100   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.000700   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
 

95001750 O    Grape                              0.697000   1.000  0.070
 

95001760 O    Grape, juice                       0.697000   0.170  0.070
 

95001761 O    Grape, juice-babyfood              0.697000   0.170  0.070
 

95001770 O    Grape, leaves                      0.697000   1.000  0.070
 

95001780 O    Grape, raisin                      0.697000   4.300  0.070
 

95001790 O    Grape, wine and sherry             0.697000   1.000  0.070
 

10001800 10   Grapefruit                         0.103000   0.060  0.130
 

10001810 10   Grapefruit, juice                  0.103000   2.100  0.130
 

14001850 14   Hickory nut                        0.019000   1.000  1.000
 

95001880 O    Hop                               11.600000   1.000  0.920
 for PH

          Full comment: for PHI=14 day, German Trial

24001890 M    Horse, meat                        0.000100   1.000  1.000
 

10001970 10   Kumquat                            0.104000   0.060  0.140
 

10001990 10   Lemon                              0.121000   0.060  0.140
 

10002000 10   Lemon, juice                       0.121000   2.000  0.140
 

10002001 10   Lemon, juice-babyfood              0.121000   2.000  0.140
 

10002010 10   Lemon, peel                        0.121000   1.200  0.140
 

10002060 10   Lime                               0.121000   0.060  0.140
 

10002070 10   Lime, juice                        0.121000   2.000  0.140
 

10002071 10   Lime, juice-babyfood               0.121000   2.000  0.140
 

11002100 11   Loquat                             0.239000   1.000  0.150
 

14002130 14   Macadamia nut                      0.019000   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
 

12002300 12   Nectarine                          0.368000   1.000  0.100
 

10002400 10   Orange                             0.104000   0.060  0.140
 

10002410 10   Orange, juice                      0.104000   1.800  0.140
 

10002411 10   Orange, juice-babyfood             0.104000   1.800  0.140
 

10002420 10   Orange, peel                       0.104000   1.200  0.140
 

12002600 12   Peach                              0.368000   1.000  0.100
 

12002601 12   Peach-babyfood                     0.368000   1.000  0.100
 

12002610 12   Peach, dried                       0.368000   7.000  0.100
 

12002611 12   Peach, dried-babyfood              0.368000   7.000  0.100
 

12002620 12   Peach, juice                       0.368000   1.000  0.100
 

12002621 12   Peach, juice-babyfood              0.368000   1.000  0.100
 

11002660 11   Pear                               0.239000   1.000  0.150
 

11002661 11   Pear-babyfood                      0.239000   1.000  0.150
 

11002670 11   Pear, dried                        0.239000   0.180  0.150
 

11002680 11   Pear, juice                        0.239000   0.030  0.150
 

11002681 11   Pear, juice-babyfood               0.239000   0.030  0.150
 

14002690 14   Pecan                              0.019000   1.000  1.000
 

14002820 14   Pistachio                          0.023000   1.000  1.000
 

12002850 12   Plum                               0.068000   1.000  0.100
 

12002851 12   Plum-babyfood                      0.068000   1.000  0.100
 

12002860 12   Plum, prune, fresh                 0.068000   2.500  0.100
 

12002861 12   Plum, prune, fresh-babyfood        0.068000   2.500  0.100
 

12002870 12   Plum, prune, dried                 0.068000   5.000  0.100
 

12002871 12   Plum, prune, dried-babyfood        0.068000   5.000  0.100
 

12002880 12   Plum, prune, juice                 0.068000   1.400  0.100
 

12002881 12   Plum, prune, juice-babyfood        0.068000   1.400  0.100
 

10003070 10   Pummelo                            0.103000   0.060  0.140
 

11003100 11   Quince                             0.239000   1.000  0.150
 

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             0.000700   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
 

10003690 10   Tangerine                          0.104000   0.060  0.140
 

10003700 10   Tangerine, juice                   0.104000   2.300  0.140
 

14003910 14   Walnut                             0.019000   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
 

Attachment 5:  DEEM-FCID( cancer exposure estimates 

Food + Water :

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for SPIRODICLOFEN                    (1994-98
data)

Residue file name: C:\Documents and Settings\msahafey\My
Documents\spirodiclofen\124871-cancer with water-122007.R98

                                                     Adjustment factor
#2 used.

Analysis Date 12-20-2007/13:16:10     Residue file dated:
12-20-2007/13:07:51/8

Q* = 0.0149 

COMMENT 1: water included

========================================================================
=======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0149)

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

U.S. Population (total)                     0.000183         2.73E-06

Food Only:

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for SPIRODICLOFEN                    (1994-98
data)

Residue file name: C:\Documents and Settings\msahafey\My
Documents\spirodiclofen\124871-cancer without water-122007.R98

                                                     Adjustment factor
#2 used.

Analysis Date 12-20-2007/13:17:13     Residue file dated:
12-20-2007/13:08:58/8

Q* = 0.0149 

COMMENT 1: Water is not included.

========================================================================
=======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .0149)

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

U.S. Population (total)                     0.000148         2.21E-06

Attachment 6:  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\msahafey\My
Documents\spirodiclofen\124871-cancer with water-112607.R98

                                                     Adjustment factor
#2 used.

Analysis Date 11-27-2007/09:57:39     Residue file dated:
11-27-2007/09:18:34/8

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 =.0001845 mg/kg bw/day

            Crop groups with total exposure contribution > 99%

              Foods/Foodforms with exposure contribution > 1%

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

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                       0.0000048     2.59%       
7.11E-08

   Grape, juice (95001760):

        FoodForm N/S                       0.0000020     1.11%       
3.05E-08

   Grape, raisin (95001780):

        FoodForm N/S                       0.0000058     3.15%       
8.65E-08

   Grape, wine and sherry (95001790):

        FoodForm N/S                       0.0000075     4.06%       
1.12E-07

   Hop (95001880):

        FoodForm N/S                       0.0000746    40.46%       
1.11E-06

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0000203    10.98%       
3.02E-07

   Water, indirect, all sources (86020000):

        FoodForm N/S                       0.0000149     8.10%       
2.23E-07

--------------------------------------  
-----------|-----------|--------------

  Total for crop group                     0.0001300    70.49%       
1.94E-06

Crop Group = (10) Citrus Fruits

   Orange, juice (10002410):

        FoodForm N/S                       0.0000307    16.62%       
4.57E-07

--------------------------------------  
-----------|-----------|--------------

  Total for crop group                     0.0000341    18.46%       
5.07E-07

Crop Group = (11) Pome Fruits

   Apple, fruit with peel (11000070):

        FoodForm N/S                       0.0000067     3.64%       
1.00E-07

   Pear (11002660):

        FoodForm N/S                       0.0000027     1.46%       
4.01E-08

--------------------------------------  
-----------|-----------|--------------

  Total for crop group                     0.0000106     5.73%       
1.57E-07

                                       1 



Crop group                               -----------Exposure
analysis----------

   Food                                     mg/kg   | % of Total|
Lifetime Risk

      Foodform                           body wt/day|  Exposure |(Q*=
.0149)

--------------------------------------  
-----------|-----------|--------------

Crop Group = (12) Stone Fruits

   Peach (12002600):

        FoodForm N/S                       0.0000034     1.85%       
5.07E-08

--------------------------------------  
-----------|-----------|--------------

  Total for crop group                     0.0000064     3.46%       
9.51E-08

Total for crop groups listed above:        0.0001811    98.14%       
2.70E-06

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

Spirodiclofen	Dietary Exposure and Risk Assessment	             DP
Number: 346757

PC Code: 124871

Page   PAGE  2  of   NUMPAGES  21