Document ID: EPA-HQ-OPP-2009-0139-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-05-05T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM  

Date:		23-September-2009

Subject:	Spirodiclofen.  Dietary Risk Assessment in Support of the
Requested use on Avocado, Black Sapote, Canistel, Mamey Sapote, Mango,
Papaya, Sapodilla, and Star Apple.  

PC Code:  124871	DP Barcode:  D367559

Decision No.:  404221	Registration No.:  264-830

Petition No.:  8F7500	Regulatory Action:  Section 3 

Risk Assessment Type:  single chemical; dietary	Case No.:  none

TXR No.:  not applicable	CAS No.:  148477-71-8

MRID Nos:  none	40 CFR:  180.608

From/To:	Tom Bloem, Chemist

Risk Assessment Branch I/Health Effects Division (RABI/HED; 7509P)

Through:		Amelia Acierto, Chemist, RABIII/HED

		Mohesen Sahafeyan, Chemist, RABVI/HED

		Dietary Exposure Science Advisory Council (DESAC)

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

				HED/RAB1 (7509P)

Executive Summary

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 for
application of spirodiclofen to avocado, black sapote, canistel, mamey
sapote, mango, papaya, sapodilla, and star apple.  Acute dietary risk
assessment was not conducted since an appropriate endpoint attributable
to a single dose was not identified for the general U.S. population or
any population subgroup.  The chronic and cancer analyses assumed the
following:  (1) average field trial residues; (2) experimentally
determined processing factors for apple and grape processed commodities
and for citrus oil, peeled citrus, and citrus peel (DEEM (ver 7.81)
defaults assumed for the remaining processed commodities); (3) BEAD
projected average percent crop treated estimates for hop (92%), pome
fruit (15%), stone fruit (10%), grape (7%), and citrus (14%); (4)
drinking water estimates derived from the Pesticide Root Zone/Exposure
Analysis Modeling System (PRZM/EXAMS) model (citrus application
scenario; 1 x 0.31 lb ai/acre) and (5) maximum reasonably balanced
livestock diets.  The resulting chronic risk estimates (food and water)
were ≤3.3% cPAD and are not of concern to HED (infants (<1 year 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 hop (40%; assumes 100% transfer
of residues from hop to beer; spirodiclofen Log KOW = 5.83), water (19%;
87% of the basin cropped and 100% crop treated), and orange (17%;
pending submission of a new processing study, default processing factors
were assumed).  

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 Mohsen Sahafeyan (D346757, 3-Jan-2008).

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 fruit
crops, livestock, and drinking water (Risk Assessment Document: 
D285047, M Clock-Rust et al, 22-Jun-2005; residue chemistry reviews: 
D341847, T. Bloem, 25-Oct-2007 and D359773, T. Bloem, 24-Jun-2009).  

Table 1:  Residues of Concern for Tolerance Expression and Risk
Assessment.

Matrix	Residues included in Risk Assessment	Residues included in
Tolerance Expression

Citrus fruit, Pome Fruit, Stone Fruit, Tree Nut1	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  Pending the submission of the orange processing data, human-health
risk assessments should assume default processing factors for all
processed commodities excluding the processed commodities for apple and
grape (D341847, T. Bloem, 25-Oct-2007).  

Recommended Tolerances:  The current petition is for application to
avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla,
and star apple (1 x 0.31 lb ai/acre; 2-day preharvest interval).  HED
determined that the conclusions concerning the residues of concern in
the currently registered fruit crops may be extended to the requested
crops (see Table 1).  Based on the review of the residue chemistry data
submitted in support of the current petition (D363343, T. Bloem,
22-Sep-2009), HED concluded that a 1.0 ppm tolerance for residues of
spirodiclofen per se in/on the requested crops is appropriate.  

Plant Residues Used in the Chronic/Cancer Risk Assessments:  The chronic
and cancer dietary analyses incorporated projected average percent crop
treated estimates and average field trial residues (see Table 2). 
Default processing factors were assumed for all commodities excluding
the processed commodities derived from apple and grape and for citrus
oil, peeled citrus, and citrus peel where experimentally determined
processing factors were incorporated (see Table 2).  To confirm that the
projected percent crop treated estimates remained appropriate, HED
requested a screening level usage analysis (SLUA) for the registered
crops (see Attachment 2).  The projected percent crop treated estimates
are greater than the SLUA for all relevant crops.  Since the projected
percent crop treated estimates are for crops registered in 2007, HED
concludes that incorporation of the SLUA data into a dietary analysis is
not appropriate at this time.  

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 Table 1 feedstuffs.  Guidance submitted along with the
revised Table 1 indicates that all three feed commodities associated
with spirodiclofen (dried citrus pulp (beef and dairy), wet apple pomace
(dairy only), and almond hulls (dairy only)) are considered alternative
feedstuffs and only one these should be included in livestock dietary
burden calculations.  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 diary cattle were used for determination
of residues in tissues as diary cattle are ultimately slaughtered for
meat.  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 Projected Ruminant Residues (ppm)	% Crop
Treated Estimates1	Processing Factors	Crop Translation and/or Comments

pome fruit	apple2 - 0.146	15	apple sauce - 0.07x; dried apple - 0.18x;
peeled apple - 0.15x; juice - 0.03x	Apple and pear residues - D285249,
T. Bloem, 18-Apr-2005.  

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

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.

	pear2 - 0.239	15	dried pear - 0.18x; pear juice - 0.03x

	citrus fruit	orange2 - 0.104	14	peeled fruit - 0.06x; juice - 1.8x
(default); oil - 69x; peel - 1.2x	Orange, lemon, and grapefruit residues
- D285249, T. Bloem, 18-Apr-2005.

Orange processing study - D285249, T. Bloem, 18-Apr-2005; orange peeled
fruit and peel processing factors translates to all citrus peeled and
peel commodities.  

Per the suggestion of BEAD, the 14% projected average orange percent
crop treated was translated to all citrus except grapefruit temple
oranges.

	lemon2 - 0.121	14	juice - 2.0x (default)

grapefruit2 - 0.103	13	juice - 2.1x (default)

	tree nut	almond2 - 0.023	100	--	Almond and pecan residues -D285249, T.
Bloem, 18-Apr-2005.

	pecan2 -0.019	100	--

	stone fruit	peach2 - 0.368	10	dried peach - 7.0x (default)	Peach, plum
and cherry residues - D285249, T. Bloem, 18-Apr-2005.

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.

	plum2 - 0.068	10	prune dried - 5.0x (default)

prune juice - 1.4x (default)

cherry2 - 0.286	10	juice - 1.5x (default)

	grape	grape - 0.697	7	raisin - 4.3x; juice - 0.17x	Grape residues -
D285249, T. Bloem, 18-Apr-2005; grape processing factors - D341847, T.
Bloem, 25-Oct-2007.

hop	hop -  11.6	92	--	-	Hop residues - 47105301.der.doc (14-day PHI).

avocado	avocado - 0.110	100	--	-	Avocado residue translated to black
sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple
based on Reviewer’s Guide and Summary of HED ChemSAC Approvals for
Amending Commodity Definitions [40CFR § 180.1(h)] and Crop
Group/Subgroups [40 CFR § 180.41] (B. Schneider; 14-Jun-2002).  Default
processing factors assumed for papaya.  

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 attachment 1.

2	Representative crops translated to the remaining crops according to
HED SOP 2000.1.  

Table 3:  Calculation of Spirodiclofen Dietary Brudens.

Feed Commodity	% Dry Matter1	% Diet1	Average Residue (ppm)2	Dietary
Contribution (ppm)3

Beef Cattle

almond hull	90	5	7.20	0.40

MTDB	--	10	--	0.41

Diary Cattle

almond hull	90	5	7.20	0.40

MTDB	--	10	--	0.41

1	Revised Table 1 Feedstuffs (June 2008).

2	Average almond hull field trial residue (D285249, T. Bloem,
18-Apr-2005)

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

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

Dose; ppm (DBx)	Residue (ppm)	Projected Residue Assuming  a 0.41 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 13.75 ppm, combined residues
of spirodiclofen and BAJ 2510 reached a plateau within the first week of
treatment ((0.004 ppm); however, a peak of 0.006 ppm was observed in a
single animal on day 20 of dosing.  

2	A milk sample collected from animals dosed at 13.75 ppm with combined
residues of 0.004 ppm was processed into whey and cream.

III.  Drinking Water Data

Surface and ground estimated drinking water concentrations were
previously generated by the Environmental Fate and Effects Division
(EFED) using PRZM-EXAMS and Screening Concentration in Ground Water
Model (SCI-GROW), respectively (D311291, F. Kahn, 4-Jan-2005).  The
SCI-GROW model was run using the highest application rate (1 x 0.53 lb
ai/acre) and resulted in a point estimate of 0.44 ppb.  Multiple crop
scenarios were modeled using PRZM-EXAMS (citrus, pecan, apple, peach,
and grape; 87% cropped and 100% crop treated assumed) with citrus (1 x
0.31 lb ai/acre) resulting in the highest 1-in-10-year peak
concentration (23.86 ppb), 1-in-10-year yearly average (4.99 ppb), and
30-year average (1.67 ppb).  Since the applications rates proposed as
part of the current petition are identical to the citrus application
rate, HED concludes that the previously generated water estimates remain
relevant.  Therefore, the chronic and cancer analyses employed the
citrus 1-in-10-year yearly average (4.99 ppb) and 30-year average (1.67
ppb), respectively.  

IV.   DEEM-FCID( Program and Consumption Information

Spirodiclofen chronic dietary exposure assessments were conducted using
the DEEM-FCID( (ver. 2.03), which incorporates consumption data from
USDA’s CSFII (1994-1996 and 1998).  The 1994-96, 98 data are based on
the reported consumption of more than 20,000 individuals over two
non-consecutive survey days.  Foods “as consumed” (i.e., apple pie)
are linked to EPA-defined food commodities (i.e., apples, peeled fruit -
cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S,
baked) using publicly available recipe translation files developed
jointly by USDA/ARS and EPA.  For chronic exposure assessment,
consumption data are averaged for the entire U.S. population and within
population subgroups, but for acute exposure assessment are retained as
individual consumption events.  Based on analysis of the 1994-96, 98
CSFII consumption data, which took into account dietary patterns and
survey respondents, HED concluded that it is most appropriate to report
risk for the following population subgroups:  the general U.S.
population, all infants (<1 year old), children 1-2, children 3-5,
children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+
years old.

For chronic dietary exposure assessment, an estimate of the residue
level in each food or food-form (i.e., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form.  The resulting residue
consumption estimate for each food/food form is summed with the residue
consumption estimates for all other food/food forms on the commodity
residue list to arrive at the total average estimated exposure. 
Exposure is expressed in mg/kg body weight/day and as a percent of the
cPAD.  This procedure is performed for each population subgroup.

IV.	Toxicological Information

Table 5 below summarizes the endpoints selected for dietary exposure
analyses; for more detailed discussion on these endpoints see the HED
risk assessment D363343 (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 ≤3.3% cPAD and are
not of concern to HED (infants (<1 year old) were the most highly
exposed population).  The cancer risk estimate (food and water) for the
U.S. population was 3 x 10-6.  

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	0.000256	1.8

All Infants (< 1 year old)

0.000455	3.3

Children 1-2 years old

0.000432	3.1

Children 3-5 years old

0.000351	2.5

Children 6-12 years old

0.000213	1.5

Youth 13-19 years old

0.000162	1.2

Females 13-49 years old

0.000201	1.4

Adults 20-49 years old

0.000283	2.0

Adults 50+ years old

0.000213	1.5

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	0.000186	3 x 10-6

VI.	Characterization of Inputs/Outputs

The chronic and cancer analyses assumed the following:  (1) average
field trial residues; (2) experimentally determined processing factors
for apple and grape processed commodities and for citrus oil, peeled
citrus, and citrus peel (DEEM (ver 7.81) defaults assumed for the
remaining processed commodities); (3) BEAD projected average percent
crop treated estimates for hop (92%), apple (15%), peach (10%), grape
(7%), and orange (14%); (4) drinking water estimates derived from the
PRZM/EXAMS model (citrus application scenario; 1 x 0.31 lb ai/acre); and
(5) maximum reasonably balanced livestock diets.  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
citrus juice, 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 (40% of the total exposure),
water (19% of the total exposure), and orange juice (16% of the total
exposure).  HED notes the following concerning the residue estimates for
hop, water, and orange juice:  (1) hop - DEEM-FCID( assumes that 100% of
the residue in hops are transferred to beer during the brewing process
(no residue 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 (average projected percent crop treated estimate);
(2) water - the water residue estimate assumed 87% of the basin is
cropped with 100% of the crops treated; and (3) orange juice - pending
the submission of a new orange processing study, default citrus juice
processing factors are to be assumed (D341847, T. Bloem, 25-Oct-2007);
in addition, assumed 14% crop treated for orange juice (average
projected percent crop treated estimate).  Therefore, HED concludes that
the cancer risk estimate provided in this assessment is conservative and
actual cancer risk will be significantly lower than 3 x 10-6.  

HED notes that spirodiclofen PDP monitoring data are available for
almonds, apple juice, raisin, and heavy cream (<LOD residues in/on all
samples).  Since these commodities contributed only 4% to the total
cancer exposure estimate, it was determined that incorporation of these
data were unnecessary.  

VII.	Conclusions

Aggregate (food + water) chronic and cancer dietary risk analyses for
spirodiclofen were conducted using DEEM-FCID (ver 2.00) to support the
Section 3 registration of spirodiclofen on avocado, black sapote,
canistel, mamey sapote, mango, papaya, sapodilla, and star apple.  The
chronic and cancer analyses assumed the following:  (1) average field
trial residues; (2) experimentally determined processing factors for
apple and grape processed commodities and for citrus oil, peeled citrus,
and citrus peel (DEEM (ver 7.81) defaults assumed for the remaining
processed commodities); (3) BEAD projected average percent crop treated
estimates for hop (92%), pome fruit (15%), stone fruit (10%), grape
(7%), and citrus (14%); (4) drinking water estimates derived from the
PRZM/EXAMS model (citrus application scenario; 1 x 0.31 lb ai/acre); and
(5) maximum reasonably balanced livestock diets.  The resulting chronic
risk estimates (food and water) were ≤3.3% cPAD and are not of concern
to HED (infants (<1 year 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 risk were hop (40%), water
(19%), and orange juice (16%). 

VIII.		List of Attachments

Attachment 1:	BEAD Projected Percent Crop Treated Estimates.

Attachment 2:	BEAD SLUA

Attachment 2:	DEEM-FCID( Chronic Residue File.

Attachment 3:	DEEM-FCID( Chronic Exposure Estimates.

Attachment 4:	DEEM-FCID( Cancer Residue File.

Attachment 5:	DEEM-FCID( Cancer Exposure Estimates.

Attachment 6:	DEEM-FCID( Critical Commodity Analysis for Cancer.

cc with all attachments:  J. Herbert/Rita Kumar (RD; RM 07; 7505P)

T. Bloem:S10945:Potomac Yard 1:703-605-0217:7509P:RAB1

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:  BEAD SLUA 

 

 

 Attachment 3:  DEEM-FCID( Chronic Residue File.

Filename: C:\Documents and Settings\tbloem\spirodiclofen\tropical
fruit\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: 08-04-2009/07:41:30/8          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   

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

95000200 O    Avocado                            0.110000   1.000  1.000
 

95000740 O    Canistel                           0.110000   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
 

95001880 O    Hop                               11.600000   1.000  0.920
 

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
 

95003330 O    Sapote, Mamey                      0.110000   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
 

21000440 M    Beef, meat                         0.000100   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.000100   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.000100   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.004000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.004000   1.000  1.000
 

21000470 M    Beef, fat                          0.000700   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.000700   1.000  1.000
 

21000480 M    Beef, kidney                       0.004000   1.000  1.000
 

21000490 M    Beef, liver                        0.000900   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.000900   1.000  1.000
 

23001690 M    Goat, meat                         0.000100   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.004000   1.000  1.000
 

23001710 M    Goat, fat                          0.000700   1.000  1.000
 

23001720 M    Goat, kidney                       0.004000   1.000  1.000
 

23001730 M    Goat, liver                        0.000900   1.000  1.000
 

24001890 M    Horse, meat                        0.000100   1.000  1.000
 

26003390 M    Sheep, meat                        0.000100   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.000100   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.004000   1.000  1.000
 

26003410 M    Sheep, fat                         0.000700   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.000700   1.000  1.000
 

26003420 M    Sheep, kidney                      0.004000   1.000  1.000
 

26003430 M    Sheep, liver                       0.000900   1.000  1.000
 

27002220 D    Milk, fat                          0.005000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.005000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.000200   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.000200   1.000  1.000
 

27022240 D    Milk, water                        0.000200   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.000200   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.000200   1.000  1.000
 

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
 

10001800 10   Grapefruit                         0.103000   0.060  0.130
 

10001810 10   Grapefruit, juice                  0.103000   2.100  0.130
 

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
 

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
 

10003070 10   Pummelo                            0.103000   0.060  0.140
 

10003690 10   Tangerine                          0.104000   0.060  0.140
 

10003700 10   Tangerine, juice                   0.104000   2.300  0.140
 

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
 

11001290 11   Crabapple                          0.146000   1.000  0.150
 

11002100 11   Loquat                             0.239000   1.000  0.150
 

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
 

11003100 11   Quince                             0.239000   1.000  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
 

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
 

12002300 12   Nectarine                          0.368000   1.000  0.100
 

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
 

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   1.000  0.100
 

12002861 12   Plum, prune, fresh-babyfood        0.068000   1.000  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
 

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
 

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  1.000
 

14001560 14   Filbert, oil                       0.019000   1.000  1.000
 

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  1.000
 

14002820 14   Pistachio                          0.023000   1.000  1.000
 

14003910 14   Walnut                             0.019000   1.000  1.000
 

Attachment 4:  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\124871chronic.R98

                                                     Adjustment factor
#2 used.

Analysis Date 08-04-2009/07:44:23     Residue file dated:
08-04-2009/07:41:30/8

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)                     0.000256                
1.8%

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

U.S. Population (summer season)             0.000275                
2.0%

U.S. Population (autumn season)             0.000239                
1.7%

U.S. Population (winter season)             0.000241                
1.7%

Northeast region                            0.000249                
1.8%

Midwest region                              0.000263                
1.9%

Southern region                             0.000231                
1.6%

Western region                              0.000297                
2.1%

Hispanics                                   0.000273                
1.9%

Non-hispanic whites                         0.000260                
1.9%

Non-hispanic blacks                         0.000219                
1.6%

Non-hisp/non-white/non-black                0.000271                
1.9%

All infants (< 1 year)                      0.000455                
3.3%

Nursing infants                             0.000192                
1.4%

Non-nursing infants                         0.000555                
4.0%

Children 1-6  yrs                           0.000366                
2.6%

Children 7-12 yrs                           0.000200                
1.4%

Females 13-19 (not preg or nursing)         0.000141                
1.0%

Females 20+ (not preg or nursing)           0.000205                
1.5%

Females 13-50 yrs                           0.000215                
1.5%

Females 13+ (preg/not nursing)              0.000198                
1.4%

Females 13+ (nursing)                       0.000230                
1.6%

Males 13-19 yrs                             0.000181                
1.3%

Males 20+ yrs                               0.000315                
2.3%

Seniors 55+                                 0.000205                
1.5%

Children 1-2 yrs                            0.000432                
3.1%

Children 3-5 yrs                            0.000351                
2.5%

Children 6-12 yrs                           0.000213                
1.5%

Youth 13-19 yrs                             0.000162                
1.2%

Adults 20-49 yrs                            0.000283                
2.0%

Adults 50+ yrs                              0.000213                
1.5%

Females 13-49 yrs                           0.000201                
1.4%

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

Attachment 5:  DEEM-FCID( Cancer Residue File.

Filename: C:\Documents and Settings\tbloem\spirodiclofen\tropical
fruit\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: 08-04-2009/07:42:18/8          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   

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

95000200 O    Avocado                            0.110000   1.000  1.000
 

95000740 O    Canistel                           0.110000   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
 

95001880 O    Hop                               11.600000   1.000  0.920
 

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
 

95003330 O    Sapote, Mamey                      0.110000   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
 

21000440 M    Beef, meat                         0.000100   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.000100   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.000100   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.004000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.004000   1.000  1.000
 

21000470 M    Beef, fat                          0.000700   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.000700   1.000  1.000
 

21000480 M    Beef, kidney                       0.004000   1.000  1.000
 

21000490 M    Beef, liver                        0.000900   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.000900   1.000  1.000
 

23001690 M    Goat, meat                         0.000100   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.004000   1.000  1.000
 

23001710 M    Goat, fat                          0.000700   1.000  1.000
 

23001720 M    Goat, kidney                       0.004000   1.000  1.000
 

23001730 M    Goat, liver                        0.000900   1.000  1.000
 

24001890 M    Horse, meat                        0.000100   1.000  1.000
 

26003390 M    Sheep, meat                        0.000100   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.000100   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.004000   1.000  1.000
 

26003410 M    Sheep, fat                         0.000700   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.000700   1.000  1.000
 

26003420 M    Sheep, kidney                      0.004000   1.000  1.000
 

26003430 M    Sheep, liver                       0.000900   1.000  1.000
 

27002220 D    Milk, fat                          0.005000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.005000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.000200   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.000200   1.000  1.000
 

27022240 D    Milk, water                        0.000200   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.000200   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.000200   1.000  1.000
 

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
 

10001800 10   Grapefruit                         0.103000   0.060  0.130
 

10001810 10   Grapefruit, juice                  0.103000   2.100  0.130
 

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
 

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
 

10003070 10   Pummelo                            0.103000   0.060  0.140
 

10003690 10   Tangerine                          0.104000   0.060  0.140
 

10003700 10   Tangerine, juice                   0.104000   2.300  0.140
 

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
 

11001290 11   Crabapple                          0.146000   1.000  0.150
 

11002100 11   Loquat                             0.239000   1.000  0.150
 

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
 

11003100 11   Quince                             0.239000   1.000  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
 

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
 

12002300 12   Nectarine                          0.368000   1.000  0.100
 

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
 

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   1.000  0.100
 

12002861 12   Plum, prune, fresh-babyfood        0.068000   1.000  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
 

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
 

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  1.000
 

14001560 14   Filbert, oil                       0.019000   1.000  1.000
 

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  1.000
 

14002820 14   Pistachio                          0.023000   1.000  1.000
 

14003910 14   Walnut                             0.019000   1.000  1.000
 

Attachment 6:  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\124871cancer.R98

                                                     Adjustment factor
#2 used.

Analysis Date 08-04-2009/07:44:45     Residue file dated:
08-04-2009/07:42:18/8

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)                     0.000186         2.78E-06

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

Attachment 7:  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\124871cancer.R98

                                                     Adjustment factor
#2 used.

Analysis Date 08-04-2009/07:45:03     Residue file dated:
08-04-2009/07:42:18/8

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 =.0001864 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

   Hop (95001880):

        FoodForm N/S                       0.0000746    40.05%       
1.11E-06

   Water, direct, all sources (86010000):

        FoodForm N/S                       0.0000203    10.87%       
3.02E-07

   Water, indirect, all sources (86020000):

        FoodForm N/S                   
†〠〮〰㄰㤴††㠠〮┱††††⸲㌲ⵅ㜰ⴍⴭⴭⴭⴭ
ⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭ‭†ⴭⴭⴭⴭⴭ簭ⴭⴭ
ⴭⴭⴭ簭ⴭⴭⴭⴭⴭⴭⴭ‍吠瑯污映牯挠潲⁰牧畯⁰†
†††††††††⸰〰㄰ㄳ‹†㜠⸰㜷‥†††ㄠ㤮
䔷〭ശ䌍潲⁰片畯⁰‽ㄨ⤰䌠瑩畲⁳牆極獴



 

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   Orange, juice (10002410):

        FoodForm N/S                       0.0000307    16.45%       
4.57E-07

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

  Total for crop group                     0.0000341    18.27%       
5.07E-07

Crop Group = (11) Pome Fruits

  Total for crop group                     0.0000106     5.67%       
1.57E-07

Total for crop groups listed above:        0.0001765    94.71%       
2.63E-06

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

Spirodiclofen	Dietary Exposure and Risk Assessment	DP Number: D367559

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