Document ID: EPA-HQ-OPP-2008-0769-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-09T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:	09-SEP-2009

SUBJECT:	Novaluron.  Chronic Dietary (Food and Drinking Water) Exposure
and Risk Assessment for the Proposed Use on Bushberry Crop Subgroup
13-07B; Brassica, Leafy Greens, Crop Subgroup 5B; Turnip Greens; and
Fruit, Stone, Crop Group 12.

PC Code:  124002	DP Num:  D359460

Decision No.: 399480	Registration No.:  66222-35-400

Petition No.:  8E7426	Regulatory Action:  Amended Section 3

Risk Assessment Type:  Dietary Exposure Assessment	Case No.:  NA

TXR No.:  NA	CAS No.:  116714-46-6

MRID No.:  NA	40 CFR:  §180.598

FROM:	Julie L. Van Alstine, MPH, Environmental Health Scientist

		Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED) (7509P)

THROUGH:	W. Cutchin, Chemist

		Douglas Dotson, Ph.D., Chemist

Dietary Exposure Science Advisory Council (DESAC)

HED (7509P)

and

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

RAB1/HED (7509P)

TO:		Julie L. Van Alstine, Risk Assessor

RAB1/HED (7509P)

and

		Barbara Madden (RM 05)

Registration Division (RD; 7505P)

Executive Summary

A chronic dietary exposure and risk assessment was conducted using the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID(, Version 2.03), which uses food consumption
data from the U.S. Department of Agriculture’s (USDA’s) Continuing
Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. 
The analysis was performed to support a request for use of novaluron on
bushberry subgroup 13-07B; Brassica, leafy greens, subgroup 5B; turnip
greens; and fruit, stone, group 12.  The last dietary risk assessment
for novaluron was conducted on 17-NOV-08 (Memo, W. Cutchin; DP# 358038).

A chronic dietary (food and drinking water) exposure and risk assessment
was conducted for the proposed uses on bushberries, Brassica leafy
greens, turnip greens, stone fruit; all established uses; and drinking
water.  A partially refined assessment was conducted.  Estimated
drinking water concentrations (EDWCs) were provided by the Environmental
Fate and Effects Division (EFED).  The chronic analysis assumed 100%
crop treated for all commodities; incorporated average field trial
residues for some commodities (pome fruit, sugarcane, bushberries,
Brassica leafy greens, and stone fruit); average greenhouse trial
residues for tomatoes; empirical processing factors for apple juice
(translated to pear and stone fruit juice), tomato paste and purée, and
dried plums; and DEEM( (ver 7.81) default processing factors for the
remaining processed commodities.  Furthermore, anticipated residues
(ARs) were used for meat and milk commodities and recommended tolerances
were used for poultry commodities.

The chronic dietary (food and drinking water) exposure to novaluron is
below HED’s level of concern for the general U.S. population and all
population subgroups.  The chronic dietary exposure estimates are 25% of
the chronic population-adjusted dose (cPAD) for the general U.S.
population and 83% of the cPAD for children 1-2 years old, the most
highly exposed population subgroup.  An acute dietary assessment was not
conducted for novaluron because an endpoint of concern attributable to a
single dose was not identified.  A cancer dietary assessment was not
conducted because novaluron was classified as “not likely to be
carcinogenic to humans.”

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 PAD.  The PAD is equivalent
to the point of departure (POD; NOAEL, LOAEL, e.g.) divided by the
required uncertainty or safety factors.  

For acute and non-cancer chronic exposures, HED is concerned when
estimated dietary risk exceeds 100% of the PAD.  HED is generally
concerned when estimated cancer risk exceeds one in one million. 
References which discuss the acute and chronic risk assessments in more
detail are available on the EPA/pesticides web site:  “Available
Information on Assessing Exposure from Pesticides, A User’s Guide,”
21-JUN-2000, web link: 
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf; or see
SOP 99.6 (20-AUG-1999).  

The last dietary risk assessment for novaluron was conducted on
17-NOV-08 (Memo, W. Cutchin; DP# 358038).

II.	Food Residue Information

Novaluron tolerances are published in 40 CFR§180.598.

Residues of Concern:  The residue of concern in crops and livestock, for
purposes of tolerance enforcement and risk assessment, is novaluron per
se.  The residues of concern in drinking water for purposes of risk
assessment are novaluron, the chlorophenyl urea degradate
(1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea),
and the chloroaniline metabolite
(3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline) (Memo, G.
Kramer et al., 03-FEB-04; DP# 297646). 

Recommended Tolerances:  Based on the summary residue chemistry data
submitted with the current petition, HED recommended for establishment
of the following tolerances for novaluron (Memo, J. L. Van Alstine,
09-SEPT-09; DP# 357060): 

Bushberry subgroup 13-07B	7.0 ppm

Brassica, leafy greens, subgroup 5B	25 ppm

Turnip, greens	25 ppm

Fruit, stone, group 12, except cherry	1.9 ppm

Cherry	8.0 ppm

Plum, prune, dried	2.6 ppm

In addition, HED previously recommended that the existing egg tolerance
be increased from 0.05 ppm to 0.07 ppm (Memo, S. Levy, 31-JAN-08; DP#
340137).

Residues used in the Chronic Analysis (see Attachments 1 and 2):  The
current chronic dietary analysis assumed 100% crop treated for all
commodities and was refined through the use of empirical processing
factors, some average field trial residues (pome fruit, sugarcane,
bushberries, Brassica leafy greens, turnip greens, and stone fruit),
average greenhouse trial residues for tomatoes, and ARs for meat and
milk commodities.  Empirical processing factors for apple juice were
translated to pear and other pome fruit juice and all stone fruit juice.
 In accordance with HED Standard Operating Procedure (SOP) 2000.1,
average field residues for apple and pear were translated to the
remaining pome fruit crops and average field residues for peaches were
translated to nectarines and apricots.  An empirical processing factor
was also used for dried plums.  

	Drinking Water Data

The drinking water residues used in the dietary risk assessment were
provided by EFED in the following memorandum:  “Novaluron and
Novaluron Degradates (Chlorophenyl urea and Chloroaniline) Drinking
Water Assessment in Support of New Use Registration Action for Stone
Fruit, Bushberries, Brassica Leafy Greens, and Turnip Greens” (I.
Maher, 10-MAR-04; DP# 357061) 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.”   

Monitoring data are not available for novaluron or its chlorophenyl urea
and chloroaniline degradates.  Concentrations in surface water and
ground water were estimated using modeling.  

Novaluron:  EFED used Tier 2 Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) modeling to estimate drinking water
concentrations for surface water for novaluron per se.  The EDWC
(1-in-10-year annual mean) for novaluron per se is 0.76 ppb.  For
groundwater, the Screening Concentration in Ground Water (SCI-GROW)
model was used to predict a groundwater concentration for novaluron. 
The EDWC for novaluron per se is 0.0056 ppb in drinking water from
shallow ground water sources.

Chlorophenyl urea and chloroaniline degradates:  A Tier 1 drinking water
analysis was performed using the FQPA Index Reservoir Screening Tool
(FIRST) model to obtain surface water estimates for the chlorophenyl
urea and chloroaniline degradates.  For surface water, the annual
average EDWC for the chlorophenyl urea degradate is 0.89 ppb and the
annual average EDWC for the chloroaniline degradate is 2.6 ppb.  The
SCI-GROW model was used to predict groundwater concentrations.  The
predicted groundwater EDWC for the chlorophenyl urea degradate is 0.0045
ppb, and for the chloroaniline degradate, the EDWC is 0.0090 ppb.

These EDWC values are meant to represent upper-bound estimates of the
concentrations that might be found in surface water and groundwater
based upon existing and proposed uses.  Of the three EDWC values, the
chronic estimate for the terminal degradate, chloroaniline, is the
highest (100% conversion from parent to the chloroaniline degradate was
assumed).  This is consistent with the expected degradation of
novaluron.  Therefore, the EDWC value for chloroaniline (2.6 ppb) was
used to assess chronic aggregate risk for this dietary assessment.  

IV.	Percent Crop Treated

For all commodities in the chronic assessment, the assumption of 100%
crop treated was made.  

V.	DEEM-FCID™ Program and Consumption Information

A novaluron chronic dietary exposure assessment was conducted using
DEEM-FCID™, Version 2.03 which incorporates consumption data from
USDA’s CSFII, 1994-1996 and 1998.  The 1994-96 and 1998 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 and
1998 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.

VI.	Toxicological Information

The HED Hazard Identification Assessment Review Committee (HIARC) met on
16-DEC-2003 to determine endpoint selection for novaluron.  At this
meeting, the HIARC also evaluated the potential for increased
susceptibility of infants and children from exposure to novaluron as
required by the FQPA of 1996 (TXR No.0052361, 04-FEB-2004).  Table 1 is
a summary of the decisions made by the HIARC concerning dietary exposure
assessment, and have been reviewed by the risk assessment team and are
still considered appropriate for the current risk assessment.  

Table 1.  Summary of Toxicological Dose and Endpoints for Novaluron.

Exposure

Scenario	

Dose Used in Risk Assessment, UF	FQPA SF and Level of Concern for Risk
Assessment	

Study and Toxicological Effects

Acute Dietary

	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= 1.1 mg/kg/day

UF = 100

Chronic RfD = 

0.011 mg/kg/day

	FQPA SF =  1X

cPAD = 

chronic RfD

FQPA SF

= 0.011 mg/kg/day	Combined chronic toxicity/carcinogenicity feeding in
rat.

LOAEL = 30.6 mg/kg/day based on erythrocyte damage and turnover
resulting in a regenerative anemia.

Cancer	Not likely to be carcinogenic to humans.

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL =
no-observed-adverse-effect-level, LOAEL =
lowest-observed-adverse-effect-level, PAD = population-adjusted dose,
RfD = reference dose.

VII.	Results/Discussion

As stated above, for a chronic assessment, HED is concerned when dietary
risk exceeds 100% of the cPAD.  The chronic analysis was performed using
DEEM-FCID( (ver. 2.03).  The DEEM-FCID( analysis estimates the dietary
exposure of the U.S. population and various population subgroups.  The
results reported in Table 2 are for 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, adults 50+ years old, and females 13-49.  The
resulting food and drinking water exposure estimates were not of concern
to HED ((100% cPAD); children 1-2 years old were the most highly exposed
population and utilized 83% of the cPAD (see Attachment 3 for details).

Table 2.  Summary of Chronic Dietary Exposure (Food and Drinking Water)
and Risk for Novaluron.

Population Subgroup	Acute Dietary	Chronic Dietary	Cancer

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

(mg/kg/day)	% cPAD	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	N/A	N/A	0.002710	25	N/A	N/A

All Infants (< 1 year old)

	0.004645	42

Children 1-2 years old

	0.009150	83

Children 3-5 years old

	0.007120	65

Children 6-12 years old

	0.004293	39

Youth 13-19 years old

	0.002346	21

Adults 20-49 years old

	0.001905	17

Adults 50+ years old

	0.001908	17

Females 13-49 years old

	0.001824	17

VIII.	Characterization of Inputs/Outputs

The chronic dietary assessment was refined through the use of empirical
processing factors, some average field trial residues (pome fruit,
sugarcane, bushberries, Brassica leafy greens, and stone fruit), average
greenhouse trial residues for tomatoes, and ARs for meat and milk
commodities.  Empirical processing factors for apple juice were
translated to pear and other pome fruit juice and all stone fruit juice.
 An empirical processing factor was also used for dried plums.  In
accordance with HED SOP 2000.1, average field residues for apple and
pear were translated to the remaining pome fruit crops and average field
residues for peaches were translated to nectarines and apricots. 
Despite this, HED concludes that the chronic estimates are conservative
since they assumed average residues based on field trial data [maximum
application rate; minimum pre-harvest interval (PHI); frozen immediately
after harvest] and assumed 100% crop treated.  The current chronic
analysis could be further refined through the following:  use of % crop
treated data; monitoring data; preparation/cooking factors; and/or ARs
for poultry commodities.

IX.	Conclusions

A chronic dietary risk assessment was conducted using DEEM-FCID( (ver.
2.03).  For this assessment, average field trial residues for
bushberries, Brassica leafy greens, and stone fruit, as well as
empirical processing factors for dried plums and stone fruit juice were
added to the last dietary assessment.  The last dietary assessment
incorporated empirical processing factors, average field trial residues
(pome fruit and sugarcane), average greenhouse trial residues
(tomatoes), and ARs for meat and milk commodities.  EDWC values,
provided by EFED, were also added to this dietary assessment.  The
chronic dietary (food and drinking water) exposure to novaluron is below
HED’s level of concern for the general U.S. population and all
population subgroups.  The chronic dietary exposure estimates are 25% of
the cPAD for the general U.S. population and 83% of the cPAD for
children 1-2 years old, the most highly exposed population subgroup.  

An acute dietary assessment was not conducted because an endpoint of
concern attributable to a single dose was not identified for novaluron. 
A cancer dietary assessment was not conducted because novaluron was
classified as “not likely to be carcinogenic to humans.”

X.	List of Attachments

Attachment 1:	AR Table.

Attachment 2:	DEEM-FCID( Chronic Residue File.

Attachment 3:	DEEM-FCID( Chronic Exposure Estimates.

cc: Julie L. Van Alstine

J.L.Van Alstine:S-10954:PY-S:(703)603-8866:7509P:RAB1

Attachment 1:  Processing Factors and Residue Estimates from Previous
Novaluron Dietary Assessment (DP# 298783, G. Kramer, 3/22/04) Updated to
Include Tomato, Sugarcane, Bushberries, Brassica Leafy Greens, and Stone
Fruit Commodities.

crop	

commodity	

processing

factor1	

residue (ppm)1	

comment

meat2	meat	1	0.112	AR

dried beef meat	dried meat	1.92	0.112	AR; DEEM (ver 7.78) default proc.
fact.

fat2	fat	1	2.43	AR

liver2	liver	1	0.190	AR

kidney2	kidney	1	0.183	AR

milk	Milk, fat	1	2.82	AR, calculated assuming residues partition into
fat

	Milk, nonfat solids	1	0.113	AR for whole milk, used to account for low
residues observed in skim milk

	Milk, water	1	0	All residues assumed to be associated with fat and
solids.

	Milk, sugar	1	0	All residues assumed to be associated with fat and
solids.

pork meat	meat	1	0.0024	AR

pork skin	skin	1	0.053	AR (fat)

pork fat	fat	1	0.053	AR

pork liver	liver	1	0.0040	AR

pork kidney	kidney	1	0.0041	AR

cotton	cottonseed oil	1	0.60	tolerance for RAC adequate to cover
residues in processed commodity

tuberous and corm vegetables	All	1	0.025	½ LOQ residue; DEEM (ver 7.78)
default proc. factor of 6.5 used for potato, dry

pome fruit – apple, crabapple 3	RAC, sauce	1	0.578	average field trial
residue

	dried	8	0.578	average field trial residue; DEEM (ver 7.78) default
proc. fact.

	juice	0.10	0.578	average field trial residue; empirical proc. fact.

pome fruit – pear + other pome fruit 3	RAC	1	0.833	average field trial
residue

	dried	6.25	0.833	average field trial residue; DEEM (ver 7.78) default
proc. fact.

	juice	0.10	0.833	average field trial residue; empirical apple proc.
fact.

sugarcane	sugar	1	0.125	average field trial residue

	molasses	1	0.125	average field trial residue

tomato	RAC	1	0.161	overall (small- & large-fruit varieties) average of
the greenhouse trial residue.

	dried	14.3	0.161	overall average of the greenhouse trial residue; DEEM
(ver 7.78) default proc. fact.

	juice	1.5	0.161	overall average of the greenhouse trial residue; DEEM
(ver 7.78) default proc. fact.

	purée	0.7	0.161	overall average of the greenhouse trial residue;
empirical proc. fact.

	paste	1.1	0.161	overall average of the greenhouse trial residue;
empirical proc. fact.

bushberry subgroup 13-07B	All	1	1.97	average blueberry field trial
residue

Brassica, leafy greens, subgroup 5B and turnip, greens	All	1	5.33
average mustard green field trial residue

plum 	RAC	1	0.403	average plum field trial residue

	dried	3.39	2.6	tolerance for dried plum

	juice	0.10	0.403	average plum field trial residue; empirical apple
proc. fact.

cherry	RAC	1	2.17	average field trial residue

	juice	0.10	2.17	average field trial residue; empirical apple proc.
fact.

peach, nectarine, and apricot4	RAC	1	0.61	average peach field trial
residue

	dried	7.0	0.61	average peach field trial residue; DEEM (ver 7.78)
default proc. fact. of 7.0 used for peaches, dried and 6.0 used for
apricots, dried

	juice	0.10	0.61	average peach field trial residue; empirical apple
proc. fact.

egg	RAC	1	0.07	recommended in Memo, S. Levy, 31-JAN-08; DP# 340137

1 See DP# 285474, G. Kramer, 3/22/04.

2 Cattle, goat, horse, and sheep.

3 Apple and pear residues were translated to the remaining pome fruit
crops using HED SOP 2000.1.

4 Peach residues were translated to nectarine and apricot crops using
HED SOP 2000.1.

Attachment 2:  DEEM-FCID( Chronic Residue File

Filename: C:\Documents and Settings\JLANGSDA\My
Documents\Chemicals\Novaluron\Bushberries, Cherries, Mustard Greens,
Plums and Peaches\DEEM RUN\124002-chronic-2009-jml__09-15-09.R98

Chemical: Novaluron

RfD(Chronic): .011 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 09-15-2009/11:04:41/8          Program ver.
2.03

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

01030150 1CD  Arrowroot, flour                   0.025000   1.000  1.000
 

01030151 1CD  Arrowroot, flour-babyfood          0.025000   1.000  1.000
 

01030170 1CD  Artichoke, Jerusalem               0.025000   1.000  1.000
 

01030820 1CD  Cassava                            0.025000   1.000  1.000
 

01030821 1CD  Cassava-babyfood                   0.025000   1.000  1.000
 

01031390 1CD  Dasheen, corm                      0.025000   1.000  1.000
 

01031660 1CD  Ginger                             0.025000   1.000  1.000
 

01031661 1CD  Ginger-babyfood                    0.025000   1.000  1.000
 

01031670 1CD  Ginger, dried                      0.025000   1.000  1.000
 

01032960 1C   Potato, chips                      0.025000   1.000  1.000
 

01032970 1C   Potato, dry (granules/ flakes)     0.025000   6.500  1.000
 

01032971 1C   Potato, dry (granules/ flakes)-b   0.025000   6.500  1.000
 

01032980 1C   Potato, flour                      0.025000   6.500  1.000
 

01032981 1C   Potato, flour-babyfood             0.025000   6.500  1.000
 

01032990 1C   Potato, tuber, w/peel              0.025000   1.000  1.000
 

01032991 1C   Potato, tuber, w/peel-babyfood     0.025000   1.000  1.000
 

01033000 1C   Potato, tuber, w/o peel            0.025000   1.000  1.000
 

01033001 1C   Potato, tuber, w/o peel-babyfood   0.025000   1.000  1.000
 

01033660 1CD  Sweet potato                       0.025000   1.000  1.000
 

01033661 1CD  Sweet potato-babyfood              0.025000   1.000  1.000
 

01033710 1CD  Tanier, corm                       0.025000   1.000  1.000
 

01033870 1CD  Turmeric                           0.025000   1.000  1.000
 

01034060 1CD  Yam, true                          0.025000   1.000  1.000
 

01034070 1CD  Yam bean                           0.025000   1.000  1.000
 

05010610 5A   Broccoli                           0.500000   1.000  1.000
 

05010611 5A   Broccoli-babyfood                  0.500000   1.000  1.000
 

05010620 5A   Broccoli, Chinese                  0.500000   1.000  1.000
 

05010640 5A   Brussels sprouts                   0.500000   1.000  1.000
 

05010690 5A   Cabbage                            0.500000   1.000  1.000
 

05010710 5A   Cabbage, Chinese, napa             0.500000   1.000  1.000
 

05010720 5A   Cabbage, Chinese, mustard          0.500000   1.000  1.000
 

05010830 5A   Cauliflower                        0.500000   1.000  1.000
 

05011960 5A   Kohlrabi                           0.500000   1.000  1.000
 

05020630 5B   Broccoli raab                      5.330000   1.000  1.000
 

05020700 5B   Cabbage, Chinese, bok choy         5.330000   1.000  1.000
 

05021170 5B   Collards                           5.330000   1.000  1.000
 

05021940 5B   Kale                               5.330000   1.000  1.000
 

05022290 5B   Mustard greens                     5.330000   1.000  1.000
 

05023180 5B   Rape greens                        5.330000   1.000  1.000
 

05023890 5B   Turnip, greens                     5.330000   1.000  1.000
 

08003750 8    Tomato                             0.161000   1.000  1.000
 

08003751 8    Tomato-babyfood                    0.161000   1.000  1.000
 

08003760 8    Tomato, paste                      0.161000   1.100  1.000
 

08003761 8    Tomato, paste-babyfood             0.161000   1.100  1.000
 

08003770 8    Tomato, puree                      0.161000   0.700  1.000
 

08003771 8    Tomato, puree-babyfood             0.161000   0.700  1.000
 

08003780 8    Tomato, dried                      0.161000  14.300  1.000
 

08003781 8    Tomato, dried-babyfood             0.161000  14.300  1.000
 

08003790 8    Tomato, juice                      0.161000   1.500  1.000
 

11000070 11   Apple, fruit with peel             0.578000   1.000  1.000
 

11000080 11   Apple, peeled fruit                0.578000   1.000  1.000
 

11000081 11   Apple, peeled fruit-babyfood       0.578000   1.000  1.000
 

11000090 11   Apple, dried                       0.578000   8.000  1.000
 

11000091 11   Apple, dried-babyfood              0.578000   8.000  1.000
 

11000100 11   Apple, juice                       0.578000   0.100  1.000
 

11000101 11   Apple, juice-babyfood              0.578000   0.100  1.000
 

11000110 11   Apple, sauce                       0.578000   1.000  1.000
 

11000111 11   Apple, sauce-babyfood              0.578000   1.000  1.000
 

11001290 11   Crabapple                          0.578000   1.000  1.000
 

11002100 11   Loquat                             0.833000   1.000  1.000
 

11002660 11   Pear                               0.833000   1.000  1.000
 

11002661 11   Pear-babyfood                      0.833000   1.000  1.000
 

11002670 11   Pear, dried                        0.833000   6.250  1.000
 

11002680 11   Pear, juice                        0.833000   0.100  1.000
 

11002681 11   Pear, juice-babyfood               0.833000   0.100  1.000
 

11003100 11   Quince                             0.833000   1.000  1.000
 

12000120 12   Apricot                            0.610000   1.000  1.000
 

12000121 12   Apricot-babyfood                   0.610000   1.000  1.000
 

12000130 12   Apricot, dried                     0.610000   6.000  1.000
 

12000140 12   Apricot, juice                     0.610000   0.100  1.000
 

12000141 12   Apricot, juice-babyfood            0.610000   0.100  1.000
 

12000900 12   Cherry                             2.170000   1.000  1.000
 

12000901 12   Cherry-babyfood                    2.170000   1.000  1.000
 

12000910 12   Cherry, juice                      2.170000   0.100  1.000
 

12000911 12   Cherry, juice-babyfood             2.170000   0.100  1.000
 

12002300 12   Nectarine                          0.610000   1.000  1.000
 

12002600 12   Peach                              0.610000   1.000  1.000
 

12002601 12   Peach-babyfood                     0.610000   1.000  1.000
 

12002610 12   Peach, dried                       0.610000   7.000  1.000
 

12002611 12   Peach, dried-babyfood              0.610000   7.000  1.000
 

12002620 12   Peach, juice                       0.610000   0.100  1.000
 

12002621 12   Peach, juice-babyfood              0.610000   0.100  1.000
 

12002850 12   Plum                               0.403000   1.000  1.000
 

12002851 12   Plum-babyfood                      0.403000   1.000  1.000
 

12002860 12   Plum, prune, fresh                 0.403000   1.000  1.000
 

12002861 12   Plum, prune, fresh-babyfood        0.403000   1.000  1.000
 

12002870 12   Plum, prune, dried                 2.600000   1.000  1.000
 

12002871 12   Plum, prune, dried-babyfood        2.600000   1.000  1.000
 

12002880 12   Plum, prune, juice                 0.403000   0.100  1.000
 

12002881 12   Plum, prune, juice-babyfood        0.403000   0.100  1.000
 

13020570 13B  Blueberry                          1.970000   1.000  1.000
 

13020571 13B  Blueberry-babyfood                 1.970000   1.000  1.000
 

13021360 13B  Currant                            1.970000   1.000  1.000
 

13021370 13B  Currant, dried                     1.970000   1.000  1.000
 

13021490 13B  Elderberry                         1.970000   1.000  1.000
 

13021740 13B  Gooseberry                         1.970000   1.000  1.000
 

13021910 13B  Huckleberry                        1.970000   1.000  1.000
 

21000440 M    Beef, meat                         0.112000   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.112000   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.112000   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.190000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.190000   1.000  1.000
 

21000470 M    Beef, fat                          2.430000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  2.430000   1.000  1.000
 

21000480 M    Beef, kidney                       0.183000   1.000  1.000
 

21000490 M    Beef, liver                        0.190000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.190000   1.000  1.000
 

23001690 M    Goat, meat                         0.112000   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.190000   1.000  1.000
 

23001710 M    Goat, fat                          2.430000   1.000  1.000
 

23001720 M    Goat, kidney                       0.183000   1.000  1.000
 

23001730 M    Goat, liver                        0.190000   1.000  1.000
 

24001890 M    Horse, meat                        0.112000   1.000  1.000
 

25002900 M    Pork, meat                         0.002400   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.002400   1.000  1.000
 

25002910 M    Pork, skin                         0.053000   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.004100   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.004100   1.000  1.000
 

25002930 M    Pork, fat                          0.053000   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.053000   1.000  1.000
 

25002940 M    Pork, kidney                       0.004100   1.000  1.000
 

25002950 M    Pork, liver                        0.004000   1.000  1.000
 

26003390 M    Sheep, meat                        0.112000   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.112000   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.190000   1.000  1.000
 

26003410 M    Sheep, fat                         2.430000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                2.430000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.183000   1.000  1.000
 

26003430 M    Sheep, liver                       0.190000   1.000  1.000
 

27002220 D    Milk, fat                          2.820000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   2.820000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.113000   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.113000   1.000  1.000
 

40000930 P    Chicken, meat                      0.030000   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.030000   1.000  1.000
 

40000940 P    Chicken, liver                     0.040000   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.040000   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.040000   1.000  1.000
 

40000960 P    Chicken, fat                       0.400000   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.400000   1.000  1.000
 

40000970 P    Chicken, skin                      0.400000   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.400000   1.000  1.000
 

50003820 P    Turkey, meat                       0.030000   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.030000   1.000  1.000
 

50003830 P    Turkey, liver                      0.040000   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.040000   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.040000   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.040000   1.000  1.000
 

50003850 P    Turkey, fat                        0.400000   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.400000   1.000  1.000
 

50003860 P    Turkey, skin                       0.400000   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.400000   1.000  1.000
 

60003010 P    Poultry, other, meat               0.030000   1.000  1.000
 

60003020 P    Poultry, other, liver              0.040000   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.040000   1.000  1.000
 

60003040 P    Poultry, other, fat                0.400000   1.000  1.000
 

60003050 P    Poultry, other, skin               0.400000   1.000  1.000
 

70001450 P    Egg, whole                         0.070000   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.070000   1.000  1.000
 

70001460 P    Egg, white                         0.070000   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.070000   1.000  1.000
 

70001470 P    Egg, yolk                          0.070000   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.070000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.002600   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.002600   1.000  1.000
 

95001280 O    Cottonseed, oil                    0.600000   1.000  1.000
 

95001281 O    Cottonseed, oil-babyfood           0.600000   1.000  1.000
 

95003590 O    Strawberry                         0.500000   1.000  1.000
 

95003591 O    Strawberry-babyfood                0.500000   1.000  1.000
 

95003600 O    Strawberry, juice                  0.500000   1.000  1.000
 

95003601 O    Strawberry, juice-babyfood         0.500000   1.000  1.000
 

95003620 O    Sugarcane, sugar                   0.125000   1.000  1.000
 

95003621 O    Sugarcane, sugar-babyfood          0.125000   1.000  1.000
 

95003630 O    Sugarcane, molasses                0.125000   1.000  1.000
 

95003631 O    Sugarcane, molasses-babyfood       0.125000   1.000  1.000
 

Attachment 3:  DEEM-FCID( Chronic Exposure Estimates

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\JLANGSDA\My
Documents\Chemicals\Novaluron\Bushberries, Cherries, Mustard Greens,
Plums and Peaches\DEEM RUN\124002-chronic-2009-jml__09-15-09.R98

                                                     Adjustment factor
#2 used.

Analysis Date 09-15-2009/11:04:54     Residue file dated:
09-15-2009/11:04:41/8

Reference dose (RfD, Chronic) = .011 mg/kg bw/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.002710               
24.6%

U.S. Population (spring season)             0.002704               
24.6%

U.S. Population (summer season)             0.002733               
24.8%

U.S. Population (autumn season)             0.002783               
25.3%

U.S. Population (winter season)             0.002609               
23.7%

Northeast region                            0.002804               
25.5%

Midwest region                              0.002745               
25.0%

Southern region                             0.002574               
23.4%

Western region                              0.002804               
25.5%

Hispanics                                   0.002890               
26.3%

Non-hispanic whites                         0.002546               
23.1%

Non-hispanic blacks                         0.003285               
29.9%

Non-hisp/non-white/non-black                0.003324               
30.2%

All infants (< 1 year)                      0.004645               
42.2%

Nursing infants                             0.002585               
23.5%

Non-nursing infants                         0.005426               
49.3%

Children 1-6  yrs                           0.007586               
69.0%

Children 7-12 yrs                           0.004012               
36.5%

Females 13-19 (not preg or nursing)         0.002043               
18.6%

Females 20+ (not preg or nursing)           0.001795               
16.3%

Females 13-50 yrs                           0.002007               
18.2%

Females 13+ (preg/not nursing)              0.002368               
21.5%

Females 13+ (nursing)                       0.002352               
21.4%

Males 13-19 yrs                             0.002630               
23.9%

Males 20+ yrs                               0.002011               
18.3%

Seniors 55+                                 0.001935               
17.6%

Children 1-2 yrs                            0.009150               
83.2%

Children 3-5 yrs                            0.007120               
64.7%

Children 6-12 yrs                           0.004293               
39.0%

Youth 13-19 yrs                             0.002346               
21.3%

Adults 20-49 yrs             
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------------------------------------------------------------------------
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Novaluron	                         Dietary Exposure & Risk Assessment	  
              DP#:  D359460

PC Code:  124002

 PAGE   

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