Document ID: EPA-HQ-OPP-2007-0331-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-12T04:00Z

UNITED STAES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

 PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	December 17, 2007  

SUBJECT:	Spiromesifen.  Chronic Dietary Exposure Assessment for the
Petition Proposing Tolerances for Residues of Spiromesifen on Beans.

PC Code:		024875   	

Decision Number:  	377056

DP Number:		342904

REVIEWER:	Breann Hanson, Biologist 

Alternative Risk Integration and Assessment (ARIA) Team

Risk Integration Minor Use and Emergency Response Branch 			
(RIMUERB)/Registration Division (RD) (7505P)

THROUGH:	William Cutchin, Chemist 

		ARIA Team

RIMERB/RD (7505P)

AND

David Hrdy, Senior Scientist

Thurston Morton, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (HED) (7509P)

TO:		Breann Hanson, Biologist

ARIA Team

RIMUERB/RD (7505P)

Executive Summary

D™, Version 2.03) which uses food consumption data from the U.S.
Department of Agriculture’s Continuing Surveys of Food Intakes by
Individuals (CSFII) from 1994-1996 and 1998.  

No toxic effects attributable to a single (i.e., acute) exposure to
spiromesifen have been identified; therefore, an acute reference dose
(aRfD) has not been established for spiromesifen and an acute dietary
exposure assessment has not been conducted.  Also, since there is no
evidence that spiromesifen is carcinogenic to humans; therefore, a
dietary cancer assessment is not required. 

Chronic Dietary (Food + Drinking Water) Exposure Results and
Characterization

A chronic dietary assessment was performed assuming tolerance-level
residues for all commodities with existing and proposed tolerances
except for the leafy-green and leafy-Brassica vegetable subgroups (4A
and 5B) (see residue chemistry discussion, Section II below).  Based on
the dietary exposure levels and the residue data from an available
ruminant feeding study, data indicate that tolerances are now
recommended in milk, whole; milk, fat; in the meat of cattle, goats,
horses, and sheep; in meat, byproducts, of cattle, goats, horses, and
sheep; and in the fat of cattle, goats, horses, and sheep.  For all
commodities, 100 percent crop treated (%CT) as well as DEEM™ Version
7.81 default processing factors were used.  The highest drinking water
estimate of 28 ppb, previously provided by the Environmental Fate and
Effects Division (EFED), was directly incorporated into the chronic
assessment.  The chronic dietary risk assessment shows that for all
included commodities, the chronic dietary risk estimates are below
ARIA’s level of concern (i.e. <100% chronic population adjusted doses
(cPAD).  For the U.S. population the exposure for food and water
utilized 32% of the cPAD.  The chronic dietary risk estimate for the
highest reported exposed population subgroup, children 3-5 years old, is
43% of the cPAD.

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 ARIA 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 chronic exposures, HED is concerned when estimated dietary risk
exceeds 100% of the PAD.  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”, 21/06/2000, web link: 
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see
SOP 99.6 (8/20/1999).

The most recent dietary risk assessment for spiromesifen was conducted
by G. Kramer (DP#s: 329711 and 329859, 8/4/2006) for its use on
greenhouse-grown tomatoes and oats.

II.	Residue Information

Spiromesifen Use:

In this analysis the chronic dietary exposure and risk estimate
resulting from food intake were determined for the general U.S.
population and various population subgroups resulting from the addition
of beans to the existing food uses for spiromesifen.

Residues of Concern in Plants:  Spiromesifen and BSN 2060-enol are the
predominant residues in crops.  The toxicity of BSN 2060-enol is
expected to be comparable to the parent compound.  BSN
2060-4-hydroxymethyl (free and conjugated) is a residue of concern in
leafy vegetables and rotational crops.

Residues of Concern in Livestock:  Spiromesifen and BSN 2060-enol are
the predominant residues in ruminants Additionally, BSN
2060-4-hydroxymethyl (free and conjugated) is a residue of concern in
ruminant commodities.

Tolerances:  Tolerances have been established under 40 CFR
§180.607(a)(1) for the combined residues of spiromesifen and its enol
metabolite, calculated as the parent compound equivalents, in/on primary
crop commodities including field corn, cotton, strawberry, and various
vegetable commodities.  The established tolerances for primary crop
commodities range from 0.02 ppm (field corn grain and tuberous and corm
vegetables, subgroup 1C) to 15 ppm (cotton gin byproducts).

Tolerances have been established under 40 CFR §180.607(a)(2) for the
combined residues of spiromesifen and its metabolites containing the
enol and 4-hydroxymethyl
(4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3
-en-2-one) moieties, expressed as parent equivalents, at 0.05 ppm for
the fat and meat byproducts of cattle, goat, horse, and sheep, and at
0.10 ppm for milk fat.

Under 40 CFR §180.607(d), tolerances for the inadvertent or indirect
combined residues of spiromesifen, its enol metabolite, and its
metabolites containing the 4-hydroxymethyl moiety, calculated as the
parent compound equivalents, have been established for rotational crops
alfalfa, barley, sugar beet, oat, and wheat commodities at 0.03-3.0 ppm.

Residue Data Used for Chronic Assessment:  The chronic assessment was
based on the assumption of tolerance-level residues for all commodities
with existing and proposed tolerances except for the leafy-green and
leafy-Brassica vegetable subgroups (4A and 5B).  An additional
metabolite, BSN 2060-4-hydroxymethyl, was observed in the metabolism
studies of lettuce only, comprising 21% of the total radioactive
residues.  Since this metabolite’s toxicity is expected to be
comparable to the parent compound, it was included in the risk
assessment for leafy crops (subgroups 4A and 5B), but not in the
tolerance expression.  To account for this additional toxicity exposure,
the recommended tolerance level was multiplied by a correction factor of
1.3x, where 1.3 = (Metabolite in Risk Assessment)/(Metabolite in
Tolerance Expression).

Recommended tolerances for bean, edible podded and cowpea forage were
calculated using the maximum residue limit (MRL)/maximum likelihood
estimation (MLE) tolerance spreadsheets.  The calculated tolerances for
bean, edible podded and cowpea, forage are 0.80 ppm and 30 ppm,
respectively.  For the purpose of this petition, ARIA recommends a
temporary tolerance of 86 ppm for cowpea hay which was calculated from
the recommended tolerance for cowpea forage (30 ppm) multiplied by the
conversion factor (2.9x) derived when percentages of dry matter (86% for
cowpea hay and 30% for cowpea forage) are taken into consideration.  No
residue data were submitted for cowpea hay.

DEEM™ 7.81 default processing factors were assumed.  The recommended
tolerances for the current petition were provided by ARIA (DP#: 345985,
D. Rate, 12/5/2007).

As part of the current petition, ARIA recommends establishing the
permanent tolerances listed in Table 1, below.

Table 1.   Tolerance Summary for Spiromesifen.

Commodity	Established Tolerance

(ppm)	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;

Correct Commodity Definition

Amends 40 CFR §180.607(a)(1):  Primary Crops

Bean, dry	None	0.02	0.02

	Bean, succulent	None	0.10	0.10

	Bean, edible podded 1	None	1.4	0.80

	Cowpea, forage	None	35	30

	Additional Tolerance on Primary Crop Commodities That Needs to be
Proposed/Established

Cowpea, hay	None	None	86 2

	Amends 40 CFR §180.607(a)(2):  Livestock Commodities

Cattle, fat	0.05	0.20	0.10

	Cattle, meat	None	0.01	0.02

	Cattle, meat byproducts	0.05	0.30	0.15	.

Goat, fat	0.05	0.20	0.10

	Goat, meat	None	0.01	0.02

	Goat, meat byproducts	0.05	0.30	0.15

	Hog, fat	None	0.20	Not required	Based on the transfer coefficients for
livestock tissues and a relatively low dietary burden for swine of 0.04
ppm for spiromesifen, tolerances for swine are not needed

Hog, meat	None	0.01	Not required

	Hog, meat byproducts	None	0.30	Not required

	Horse, fat	0.05	0.20	0.10	.

Horse, meat	None	0.01	0.02

	Horse, meat byproducts	0.05	0.30	0.15

	Milk	None	0.01	0.01

	Milk, fat	0.10	None	0.20 

	Sheep, fat	0.05	0.20	0.10

	Sheep, meat	None	0.01	0.02

	Sheep, meat byproducts	0.05	0.30	0.15

	1  According to the Food Feed Commodity Vocabulary edible podded bean
is not listed as a preferred term, however, in an email correspondence
between B. Schneider and the petitioner, dated 09/JAN/2007, B. Schneider
indicated that bean, edible podded is the correct tolerance term.

2   Calculated from the recommended tolerance for cowpea forage (30 ppm)
multiplied by the conversion factor (2.9x) derived when percentages of
dry matter (86% for cowpea hay and 30% for cowpea forage) are taken into
consideration.

III.	Drinking Water Data

The drinking water residues used in the dietary risk assessment were
provided by EFED (DP#: 300469, K. Martin, et. al., 2/17/2005) and
incorporated directly into this dietary assessment.  Water residues were
incorporated in the DEEM-FCID into the food categories “water, direct,
all sources” and “water, indirect, all sources.” 

Because monitoring data are unavailable, estimates for spiromesifen
concentrations were made only with mathematical models.  The models
Pesticide Root Zone Model (PRZM) (version 3.12 beta) and Exposure
Analysis Modeling System (EXAMS) (version 2.98.04) were used to conduct
surface water exposure assessments.  Screening Concentration in Ground
Water (SCIGROW) (version 2.3) was used for groundwater.  Estimated
drinking water concentrations (EDWCs) were generated for the total toxic
residue which includes spiromesifen, the -enol and -carboxy metabolites,
and unextracted material.  The highest estimated surface water
concentrations occurred with the NC sweet potato scenario.  For chronic
assessments the EDWC is 11 ppb.  The groundwater estimate from SCIGROW
is 28 ppb; this was the value used in this assessment.

.	DEEM-FCID™ Program and Consumption Information

A spiromesifen chronic dietary exposure assessment was conducted using
the Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID™, Version 2.03), which incorporates
consumption data from USDA’s Continuing Surveys of Food Intakes by
Individuals (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” (e.g., apple pie)
are linked to EPA-defined food commodities (e.g. 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 (e.g., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form to produce a residue intake
estimate.  The resulting residue intake estimate for each food/food form
is summed with the residue intake 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.

V.	Toxicological Information

Spiromesifen shows no significant developmental or reproductive effects,
is not likely to be carcinogenic based on bioassays in rat and mouse,
and lacks in vivo and in vitro mutagenic effects.  Based on the
chemical’s mode of action and the available data from multiple
studies, the chemical is not considered a neurotoxin.  There are no
residual uncertainties that indicate the need for a safety factor.  The
FQPA safety factor has been reduced to 1X.

Acute dietary exposure limits for all populations, including infants and
children, were not established since an endpoint of concern attributable
to a single dose was not identified.  In addition, there are no
developmental concerns based on rat and/or rabbit developmental toxicity
studies.  

The chronic RfD (and cPAD) for spiromesifen is 0.022 mg/kg/day based on
the NOAEL (2.2 mg/kg/day).  The uncertainty factor used in determining
cRfD was 100:  10X for interspecies extrapolation; and 10X for
intraspecies variations.  

Table 2.  Summary of Toxicological Endpoints for Use in Human Health
Risk Assessment*

Exposure

Scenario	Dose Used in Risk Assessment,

UF	FQPA SF and Level of Concern for Risk Assessment	Study and
Toxicological Effects

Acute Dietary

All populations	Not applicable	

	None	An endpoint of concern attributable to a single dose was not
identified.  An acute RfD was not established.

Chronic Dietary

all populations	NOAEL=2.2 mg/kg/day

UF=100X

Chronic RfD=0.022 mg/kg/day

	

cPAD=0.022 mg/kg/day	1X	2-generation reproduction rats

The parental systemic LOAEL (M/F)=13.2/91.0 mg/kg bw/day based on
decreased body weight and spleen weight in males; and decreased body
weight, spleen weight, atrophy of adrenal zona glomerulosa, and thyroid
follicular cell hypertrophy in F1 females

Cancer (oral, dermal, inhalation)	Classification:  Not likely to be
carcinogenic to humans	

*UF = uncertainty factor; NOAEL = no observed adverse effect level;
LOAEL = lowest observed adverse effect level; PAD = population adjusted
dose (a = acute, c = chronic).

VI.	Results/Discussion 

is concerned when dietary risk exceeds 100% of the cPAD.  The
DEEM-FCID™ analyses estimate the dietary exposure of the U.S.
population and various population subgroups.  The results reported in
Table 3 are for the general U.S. Population, all infants (<1 year old),
children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49,
adults 20-49, and adults 50+ years.  

Results of Chronic Dietary Exposure Analysis

Spiromesifen chronic dietary (food + water) exposure estimates using the
DEEM-FCID™ software are below ARIA’s level of concern for the U.S.
population and each of the population subgroups, Table 3.  Chronic
dietary exposure utilized 32% of the cPAD for the U.S. population.  The
chronic dietary exposure for the highest reported exposed population
subgroup, children 3-5 years old, was 43% of the cPAD.

The results of the chronic dietary exposure analysis are reported in the
Summary Table (Table 3, below).  

Table 3.  Summary of Dietary (Food and Water) Exposure Risk for
Spiromesifen

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary

	Dietary Exposure (mg/kg/day)	% aPAD*	Dietary Exposure

(mg/kg/day)	% cPAD*

General U.S. Population	N/A	0.007113	32

All Infants (< 1 year old)

0.005633	26

Children 1-2 years old

0.009347	43

Children 3-5 years old

0.009357	43

Children 6-12 years old

0.007285	33

Youth 13-19 years old

0.006111	28

Adults 20-49 years old

0.007077	32

Adults 50+ years old

0.006893	31

Females 13-49 years old

0.007217	33

* % PADs are reported to 2 significant figures.

* *The values for the highest exposed population for each type of risk
assessment are bolded.

The chronic dietary exposure and risk estimates are conservative as they
assumed 100% CT and ARIA recommended/established tolerance-level
residues for all commodities except leafy vegetables.  A 1.3x correction
factor was applied to leafy vegetables to account for the additional
metabolite.  Conservative DEEM-FCIDTM default processing factors were
applied to all processed commodities in the analyses.  The chronic
analysis could be further refined through the use of average residues
based on field trial data, percent crop treated data and/or
preparation/cooking factors.  Since risk estimates are below ARIA’s
level of concern, a more highly refined analysis is not needed at this
time.

VII.	Conclusions

The chronic dietary (food + drinking water) exposure to spiromesifen is
below ARIA’s level of concern for the general U.S. population and all
population subgroups.  The chronic dietary exposure utilized 32% of the
cPAD for the general U.S. population and 43% of the cPAD for children
3-5 years old, the most highly exposed population subgroup. 

VIII.	List of Attachments

Attachment 1:  Chronic Food plus Water Residue Input File

Attachment 2:  Chronic Results File

 Attachment 1:  Chronic Food plus Water Residue Input File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for SPIROMESIFEN                      
1994-98 data

Residue file: C:\Documents and Settings\bhanson\My Documents\Breann's
Work\ARIA\Spiromesifen\Finals\Spiromesifen.R98

                                                           Adjust. #2
NOT used

Analysis Date 12-13-2007             Residue file dated:
12-13-2007/13:40:04/8

Reference dose (RfD) = 0.022 mg/kg bw/day

Comment:7E7195

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

04010050 4A   Amaranth, leafy                   15.600000   1.000     
1.000   3F6537

01030150 1CD  Arrowroot, flour                   0.020000   1.000     
1.000   3F6537

01030151 1CD  Arrowroot, flour-babyfood          0.020000   1.000     
1.000   3F6537

01030170 1CD  Artichoke, Jerusalem               0.020000   1.000     
1.000   3F6537

04010180 4A   Arugula                           15.600000   1.000     
1.000   3F6537

09020210 9B   Balsam pear                        0.100000   1.000     
1.000   3F6537

15000250 15   Barley, pearled barley             0.030000   1.000     
1.000   3F6537

15000251 15   Barley, pearled barley-babyfood    0.030000   1.000     
1.000   3F6537

15000260 15   Barley, flour                      0.030000   1.000     
1.000   3F6537

15000261 15   Barley, flour-babyfood             0.030000   1.000     
1.000   3F6537

15000270 15   Barley, bran                       0.030000   1.000     
1.000   3F6537

06030300 6C   Bean, black, seed                  0.020000   1.000     
1.000   7E7195

06020310 6B   Bean, broad, succulent             0.100000   1.000     
1.000   7E7195

06030320 6C   Bean, broad, seed                  0.020000   1.000     
1.000   7E7195

06020330 6B   Bean, cowpea, succulent            0.100000   1.000     
1.000   7E7195

06030340 6C   Bean, cowpea, seed                 0.020000   1.000     
1.000   7E7195

06030350 6C   Bean,  great northern, seed        0.020000   1.000     
1.000   7E7195

06030360 6C   Bean, kidney, seed                 0.020000   1.000     
1.000   7E7195

06020370 6B   Bean, lima, succulent              0.100000   1.000     
1.000   7E7195

06030380 6C   Bean, lima, seed                   0.020000   1.000     
1.000   7E7195

06030390 6C   Bean, mung, seed                   0.020000   1.000     
1.000   7E7195

06030400 6C   Bean, navy, seed                   0.020000   1.000     
1.000   7E7195

06030410 6C   Bean, pink, seed                   0.020000   1.000     
1.000   7E7195

06030420 6C   Bean, pinto, seed                  0.020000   1.000     
1.000   7E7195

06010430 6A   Bean, snap, succulent              0.800000   1.000     
1.000   7E7195

06010431 6A   Bean, snap, succulent-babyfood     0.800000   1.000     
1.000   7E7195

21000440 M    Beef, meat                         0.020000   1.000     
1.000   7E7195

21000441 M    Beef, meat-babyfood                0.020000   1.000     
1.000   7E7195

21000450 M    Beef, meat, dried                  0.020000   1.920     
1.000   7E7195

21000460 M    Beef, meat byproducts              0.150000   1.000     
1.000   7E7195

21000461 M    Beef, meat byproducts-babyfood     0.150000   1.000     
1.000   7E7195

21000470 M    Beef, fat                          0.100000   1.000     
1.000   7E7195

21000471 M    Beef,fat-babyfood                  0.100000   1.000     
1.000   7E7195

21000480 M    Beef, kidney                       0.150000   1.000     
1.000   7E7195

21000490 M    Beef, liver                        0.150000   1.000     
1.000   7E7195

21000491 M    Beef, liver-babyfood               0.150000   1.000     
1.000   7E7195

01010520 1A   Beet, sugar                        0.030000   1.000     
1.000   3F6537

01010521 1A   Beet, sugar-babyfood               0.030000   1.000     
1.000   3F6537

01010530 1A   Beet, sugar, molasses              0.030000   1.000     
1.000   3F6537

01010531 1A   Beet, sugar, molasses-babyfood     0.030000   1.000     
1.000   3F6537

05010610 5A   Broccoli                           2.000000   1.000     
1.000   3F6537

05010611 5A   Broccoli-babyfood                  2.000000   1.000     
1.000   3F6537

05010620 5A   Broccoli, Chinese                  2.000000   1.000     
1.000   3F6537

05020630 5B   Broccoli raab                     15.600000   1.000     
1.000   3F6537

05010640 5A   Brussels sprouts                   2.000000   1.000     
1.000   3F6537

05010690 5A   Cabbage                            2.000000   1.000     
1.000   3F6537

05020700 5B   Cabbage, Chinese, bok choy        15.600000   1.000     
1.000   3F6537

05010710 5A   Cabbage, Chinese, napa             2.000000   1.000     
1.000   3F6537

05010720 5A   Cabbage, Chinese, mustard          2.000000   1.000     
1.000   3F6537

09010750 9A   Cantaloupe                         0.100000   1.000     
1.000   3F6537

09010800 9A   Casaba                             0.100000   1.000     
1.000   3F6537

01030820 1CD  Cassava                            0.020000   1.000     
1.000   3F6537

01030821 1CD  Cassava-babyfood                   0.020000   1.000     
1.000   3F6537

05010830 5A   Cauliflower                        2.000000   1.000     
1.000   3F6537

09020880 9B   Chayote, fruit                     0.100000   1.000     
1.000   3F6537

06030980 6C   Chickpea, seed                     0.020000   1.000     
1.000   7E7195

06030981 6C   Chickpea, seed-babyfood            0.020000   1.000     
1.000   7E7195

06030990 6C   Chickpea, flour                    0.020000   1.000     
1.000   7E7195

09021020 9B   Chinese waxgourd                   0.100000   1.000     
1.000   3F6537

04011040 4A   Chrysanthemum, garland            15.600000   1.000     
1.000   3F6537

05021170 5B   Collards                          15.600000   1.000     
1.000   3F6537

15001200 15   Corn, field, flour                 0.020000   1.000     
1.000   3F6537

15001201 15   Corn, field, flour-babyfood        0.020000   1.000     
1.000   3F6537

15001210 15   Corn, field, meal                  0.020000   1.000     
1.000   3F6537

15001211 15   Corn, field, meal-babyfood         0.020000   1.000     
1.000   3F6537

15001220 15   Corn, field, bran                  0.020000   1.000     
1.000   3F6537

15001230 15   Corn, field, starch                0.020000   1.000     
1.000   3F6537

15001231 15   Corn, field, starch-babyfood       0.020000   1.000     
1.000   3F6537

15001240 15   Corn, field, syrup                 0.020000   1.500     
1.000   3F6537

15001241 15   Corn, field, syrup-babyfood        0.020000   1.500     
1.000   3F6537

15001250 15   Corn, field, oil                   0.020000   1.000     
1.000   3F6537

15001251 15   Corn, field, oil-babyfood          0.020000   1.000     
1.000   3F6537

95001280 O    Cottonseed, oil                    0.500000   1.000     
1.000   3F6537

95001281 O    Cottonseed, oil-babyfood           0.500000   1.000     
1.000   3F6537

04011330 4A   Cress, garden                     15.600000   1.000     
1.000   3F6537

04011340 4A   Cress, upland                     15.600000   1.000     
1.000   3F6537

09021350 9B   Cucumber                           0.100000   1.000     
1.000   3F6537

04011380 4A   Dandelion, leaves                 15.600000   1.000     
1.000   3F6537

01031390 1CD  Dasheen, corm                      0.020000   1.000     
1.000   3F6537

08001480 8    Eggplant                           0.450000   1.000     
1.000   3F6537

04011500 4A   Endive                            15.600000   1.000     
1.000   3F6537

01031660 1CD  Ginger                             0.020000   1.000     
1.000   3F6537

01031661 1CD  Ginger-babyfood                    0.020000   1.000     
1.000   3F6537

01031670 1CD  Ginger, dried                      0.020000   1.000     
1.000   3F6537

23001690 M    Goat, meat                         0.020000   1.000     
1.000   7E7195

23001700 M    Goat, meat byproducts              0.150000   1.000     
1.000   7E7195

23001710 M    Goat, fat                          0.100000   1.000     
1.000   7E7195

23001720 M    Goat, kidney                       0.150000   1.000     
1.000   7E7195

23001730 M    Goat, liver                        0.150000   1.000     
1.000   7E7195

06031820 6C   Guar, seed                         0.020000   1.000     
1.000   7E7195

06031821 6C   Guar, seed-babyfood                0.020000   1.000     
1.000   7E7195

09011870 9A   Honeydew melon                     0.100000   1.000     
1.000   3F6537

24001890 M    Horse, meat                        0.020000   1.000     
1.000   7E7195

05021940 5B   Kale                              15.600000   1.000     
1.000   3F6537

05011960 5A   Kohlrabi                           2.000000   1.000     
1.000   3F6537

06032030 6C   Lentil, seed                       0.020000   1.000     
1.000   7E7195

04012040 4A   Lettuce, head                     15.600000   1.000     
1.000   3F6537

04012050 4A   Lettuce, leaf                     15.600000   1.000     
1.000   3F6537

27002220 D    Milk, fat                          0.200000   1.000     
1.000   3F6537

27002221 D    Milk, fat - baby food/infant for   0.200000   1.000     
1.000   3F6537

27012230 D    Milk, nonfat solids                0.010000   1.000     
1.000   7E7195

27012231 D    Milk, nonfat solids-baby food/in   0.010000   1.000     
1.000   7E7195

27022240 D    Milk, water                        0.010000   1.000     
1.000   7E7195

27022241 D    Milk, water-babyfood/infant form   0.010000   1.000     
1.000   7E7195

27032251 D    Milk, sugar (lactose)-baby food/   0.010000   1.000     
1.000   7E7195

05022290 5B   Mustard greens                    15.600000   1.000     
1.000   3F6537

15002310 15   Oat, bran                          0.030000   1.000     
1.000   

15002320 15   Oat, flour                         0.030000   1.000     
1.000   

15002321 15   Oat, flour-babyfood                0.030000   1.000     
1.000   

15002330 15   Oat, groats/rolled oats            0.030000   1.000     
1.000   

15002331 15   Oat, groats/rolled oats-babyfood   0.030000   1.000     
1.000   

08002340 8    Okra                               0.450000   1.000     
1.000   

04012480 4A   Parsley, leaves                   15.600000   1.000     
1.000   3F6537

06022550 6B   Pea, succulent                     0.100000   1.000     
1.000   7E7195

06022551 6B   Pea, succulent-babyfood            0.100000   1.000     
1.000   7E7195

06032560 6C   Pea, dry                           0.020000   1.000     
1.000   7E7195

06032561 6C   Pea, dry-babyfood                  0.020000   1.000     
1.000   7E7195

06012570 6A   Pea, edible podded, succulent      0.800000   1.000     
1.000   7E7195

06032580 6C   Pea, pigeon, seed                  0.020000   1.000     
1.000   7E7195

06022590 6B   Pea, pigeon, succulent             0.100000   1.000     
1.000   7E7195

08002700 8    Pepper, bell                       0.450000   1.000     
1.000   3F6537

08002701 8    Pepper, bell-babyfood              0.450000   1.000     
1.000   3F6537

08002710 8    Pepper, bell, dried                0.450000   1.000     
1.000   3F6537

08002711 8    Pepper, bell, dried-babyfood       0.450000   1.000     
1.000   3F6537

08002720 8    Pepper, nonbell                    0.450000   1.000     
1.000   3F6537

08002721 8    Pepper, nonbell-babyfood           0.450000   1.000     
1.000   3F6537

08002730 8    Pepper, nonbell, dried             0.450000   1.000     
1.000   3F6537

01032960 1C   Potato, chips                      0.020000   1.000     
1.000   3F6537

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500     
1.000   3F6537

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500     
1.000   3F6537

01032980 1C   Potato, flour                      0.020000   1.000     
1.000   3F6537

01032981 1C   Potato, flour-babyfood             0.020000   1.000     
1.000   3F6537

01032990 1C   Potato, tuber, w/peel              0.020000   1.000     
1.000   3F6537

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000     
1.000   3F6537

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000     
1.000   3F6537

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000     
1.000   3F6537

09023080 9B   Pumpkin                            0.100000   1.000     
1.000   3F6537

09023090 9B   Pumpkin, seed                      0.100000   1.000     
1.000   3F6537

04013130 4A   Radicchio                         15.600000   1.000     
1.000   3F6537

05023180 5B   Rape greens                       15.600000   1.000     
1.000   3F6537

26003390 M    Sheep, meat                        0.020000   1.000     
1.000   7E7195

26003391 M    Sheep, meat-babyfood               0.020000   1.000     
1.000   7E7195

26003400 M    Sheep, meat byproducts             0.150000   1.000     
1.000   7E7195

26003410 M    Sheep, fat                         0.100000   1.000     
1.000   7E7195

26003411 M    Sheep, fat-babyfood                0.100000   1.000     
1.000   7E7195

26003420 M    Sheep, kidney                      0.150000   1.000     
1.000   7E7195

26003430 M    Sheep, liver                       0.150000   1.000     
1.000   7E7195

04013550 4A   Spinach                           15.600000   1.000     
1.000   3F6537

04013551 4A   Spinach-babyfood                  15.600000   1.000     
1.000   3F6537

09023560 9B   Squash, summer                     0.100000   1.000     
1.000   3F6537

09023561 9B   Squash, summer-babyfood            0.100000   1.000     
1.000   3F6537

09023570 9B   Squash, winter                     0.100000   1.000     
1.000   3F6537

09023571 9B   Squash, winter-babyfood            0.100000   1.000     
1.000   3F6537

95003590 O    Strawberry                         2.000000   1.000     
1.000   3F6537

95003591 O    Strawberry-babyfood                2.000000   1.000     
1.000   3F6537

95003600 O    Strawberry, juice                  2.000000   1.000     
1.000   3F6537

95003601 O    Strawberry, juice-babyfood         2.000000   1.000     
1.000   3F6537

01033660 1CD  Sweet potato                       0.020000   1.000     
1.000   3F6537

01033661 1CD  Sweet potato-babyfood              0.020000   1.000     
1.000   3F6537

01033710 1CD  Tanier, corm                       0.020000   1.000     
1.000   3F6537

08003740 8    Tomatillo                          0.450000   1.000     
1.000   3F6537

08003750 8    Tomato                             0.450000   1.000     
1.000   3F6537

08003751 8    Tomato-babyfood                    0.450000   1.000     
1.000   3F6537

08003760 8    Tomato, paste                      0.600000   1.000     
1.000   3F6537

08003761 8    Tomato, paste-babyfood             0.600000   1.000     
1.000   3F6537

08003770 8    Tomato, puree                      0.450000   3.300     
1.000   3F6537

08003771 8    Tomato, puree-babyfood             0.450000   3.300     
1.000   3F6537

08003780 8    Tomato, dried                      0.450000  14.300     
1.000   3F6537

08003781 8    Tomato, dried-babyfood             0.450000  14.300     
1.000   3F6537

08003790 8    Tomato, juice                      0.450000   1.500     
1.000   3F6537

01033870 1CD  Turmeric                           0.020000   1.000     
1.000   3F6537

86010000 O    Water, direct, all sources         0.028000   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.028000   1.000     
1.000   

09013990 9A   Watermelon                         0.100000   1.000     
1.000   3F6537

09014000 9A   Watermelon, juice                  0.100000   1.000     
1.000   3F6537

15004010 15   Wheat, grain                       0.030000   1.000     
1.000   3F6537

15004011 15   Wheat, grain-babyfood              0.030000   1.000     
1.000   3F6537

15004020 15   Wheat, flour                       0.030000   1.000     
1.000   3F6537

15004021 15   Wheat, flour-babyfood              0.030000   1.000     
1.000   3F6537

15004030 15   Wheat, germ                        0.030000   1.000     
1.000   3F6537

15004040 15   Wheat, bran                        0.030000   1.000     
1.000   3F6537

01034060 1CD  Yam, true                          0.020000   1.000     
1.000   3F6537

01034070 1CD  Yam bean                           0.020000   1.000     
1.000   3F6537

Attachment 2:  Chronic Results File

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\bhanson\My
Documents\Breann's Work\ARIA\Spiromesifen\Finals\Spiromesifen.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 12-13-2007/13:40:47     Residue file dated:
12-13-2007/13:40:04/8

Reference dose (RfD, Chronic) = .022 mg/kg bw/day

COMMENT 1: 7E7195

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.007113               
32.3%

U.S. Population (spring season)             0.007371               
33.5%

U.S. Population (summer season)             0.006989               
31.8%

U.S. Population (autumn season)             0.007018               
31.9%

U.S. Population (winter season)             0.007084               
32.2%

Northeast region                            0.007366               
33.5%

Midwest region                              0.007021               
31.9%

Southern region                             0.006515               
29.6%

Western region                             
0.0079㈳††††††††㘳ㄮഥ䠍獩慰楮獣†††††
††††††††††††〠〮㘰㈸″†††††††
㌠⸱┰不湯栭獩慰楮⁣桷瑩獥†††††††††††
†〠〮㜰〰′†††††††㌠⸱┸不湯栭獩慰楮⁣汢
捡獫††††††††††††〠〮㘰〹‴†††††
††㌠⸱┴

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Non-hisp/non-white/non-black                0.010221               
46.5%

All infants (< 1 year)                      0.005633               
25.6%

Nursing infants                             0.002377               
10.8%

Non-nursing infants                         0.006868               
31.2%

Children 1-6  yrs                           0.009193               
41.8%

Children 7-12 yrs                           0.007087               
32.2%

Females 13-19 (not preg or nursing)         0.005935               
27.0%

Females 20+ (not preg or nursing)           0.007421               
33.7%

Females 13-50 yrs                           0.007176               
32.6%

Females 13+ (preg/not nursing)              0.006316               
28.7%

Females 13+ (nursing)                       0.008336               
37.9%

Males 13-19 yrs                             0.006223               
28.3%

Males 20+ yrs                               0.006580               
29.9%

Seniors 55+                                 0.006736               
30.6%

Children 1-2 yrs                            0.009347               
42.5%

Children 3-5 yrs                            0.009357               
42.5%

Children 6-12 yrs                           0.007285               
33.1%

Youth 13-19 yrs                             0.006111               
27.8%

Adults 20-49 yrs                            0.007077               
32.2%

Adults 50+ yrs                              0.006893               
31.3%

Females 13-49 yrs                           0.007217               
32.8%

Spiromesifen	Dietary Exposure and Risk Assessment	DP Number: 342904	

PC Code: 024875	

________________________________________________________________________
______________

 PAGE   

	Page   PAGE  14  of   NUMPAGES  16