Document ID: EPA-HQ-OPP-2007-0438-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-10T05:00Z

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:		07-FEB-2008

Subject:	Novaluron.  Chronic Dietary Exposure and Risk Assessment for
the Section 3 Registration on Sugarcane and Tomato (PP#7E7199).  

PC Code:  124002.  DP#:  347657.  Decision#:  379033.

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

Registration Action Branch 1 (RAB1)

Health Effects Division (HED) (7509P)

To:		Mary Clock-Rust, Risk Assessor

RAB1/HED (7509P)

Through:	Thurston Morton, Chemist

Sarah Winfield, Biologist

Dietary Exposure Science Advisory Council (DESAC)/HED (7509P)

and

P.V. Shah, Ph.D. Branch Senior Scientist

RAB1/HED (7509P)

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 USDA’s Continuing Surveys of Food Intakes by Individuals
(CSFII) from 1994-1996 and 1998.  The analysis was performed to support
a Section 3 request for use of novaluron on sugarcane and tomato.  The
last dietary risk assessment for novaluron was conducted on 26-JUL-2006
(Memo, S. Levy; DP# 322553).

Chronic:  The current chronic dietary assessment is an update of the
previous dietary assessment conducted in 2005 (i.e., average field trial
residue values for the raw agricultural commodities (RACs) associated
with this action and empirical processing factors for tomato purée and
paste were added to the last dietary assessment).  Estimated drinking
water concentrations (EDWCs), provided by the Environmental Fate and
Effects Division (EFED), were included in this assessment as well.  In
the last dietary assessment, the chronic analysis assumed 100% crop
treated for all commodities; incorporated average field trial residues
for some commodities; empirical processing factors for apple juice
(translated to pear juice); 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.

For this dietary assessment, the resulting chronic food + water exposure
estimates were not of concern to HED ((74% of the chronic
population-adjusted dose (cPAD); children 1-2 years old were the most
highly exposed population).  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 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 last dietary risk assessment for novaluron
was conducted on 26-JUL-2006 (Memo, S. Levy; DP# 322553).

II.	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 metabolite
(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-2004; DP# 297646) (see Table 1).



Table 1:  Novaluron Residues of Concern in Plants, Ruminants, and
Drinking Water.

Matrix	Residues of Concern

	For Risk Assessment	For Tolerance Expression

Plants	Parent only	Parent only

Ruminant	Parent only	Parent only

Milk	Parent only	Parent only

Water	Parent, the chlorophenyl urea metabolite, and the chloroaniline
metabolite	NA

Recommended Tolerances:  Based on the residue chemistry data submitted
with the current petition, HED recommended for establishment of the
tolerances listed in Table 2 (Memo, G. Kramer, 07-FEB-2008; D340137). 
In addition, HED has recommended that the existing egg tolerance should
be increased to 0.07 ppm (Memo, S. Levy, 31-JAN-2008; D340137).

Table 2:  HED-Recommended Tolerances for Novaluron.

Commodity	

Recommended Tolerance (ppm)

Tomato	

1.0

Sugarcane, cane	

0.50

Eggs	0.07

Residues used in the Chronic Analysis (see Attachments 1 and 2):  In the
last dietary assessment, the chronic analysis assumed 100% crop treated
for all commodities; incorporated average field trial residues for some
commodities; empirical processing factors for apple juice (translated to
pear juice); and DEEM( (ver 7.81) default processing factors for the
remaining processed commodities.  Furthermore, ARs were calculated for
meat and milk commodities and recommended tolerances were used for
poultry commodities.

The sugarcane commodities associated with the current petition were
added at the average field trial residue value (0.125 ppm) to the last
dietary assessment.  For tomatoes, an overall (small- & large-fruit
varieties) average of the greenhouse trial residues (0.161 ppm) was
used.  Empirical processing factors were used for tomato purée and
paste.

Water Residues Used in the Analyses:  The drinking water values used in
this dietary risk assessment were provided by the EFED (Memo, I. Maher,
11-FEB-2004; DP#285477).  Monitoring data are not available for
novaluron or its degradates, chlorophenyl urea and chloroaniline, in
surface water or ground water.  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 1.8 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 0.0055 ppb in drinking water from
shallow ground water sources.

Chlorophenyl urea and chloroaniline degradates:  A Tier I 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 chlorophenyl urea is 0.86 ppb and the annual average
EDWC for chloroaniline is 2.6 ppb.  For ground water, the SCI-GROW model
was used to predict groundwater concentrations.  The predicted ground
water EDWC for chlorophenyl urea is 0.0045 ppb, and for chloroaniline
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,
chronic estimates for the terminal metabolite, chloroaniline is the
highest (100% conversion from parent to aniline was assumed).  This is
consistent with the expected degradation pattern for novaluron. 
Therefore, the EDWC value for chloroaniline (2.6 ppb) was used to assess
chronic aggregate risk for this dietary assessment.  EFED has confirmed
that this value is applicable to the current action (Memo, I. Maher,
13-DEC-2007; D340579).

III.	Program and Consumption Information

DEEM-FCID( Program and Consumption Information:  A novaluron chronic
dietary exposure assessment was 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.
 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

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 3 is
a summary of the decisions made by the HIARC concerning dietary exposure
assessment, and are still considered appropriate for the current risk
assessment.

Table 3.  Summary of Toxicological Dose and Endpoints for Novaluron.

Exposure

Scenario	

Dose Used in Risk Assessment, UF	

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

V.	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 4 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 old.  The
resulting food + water exposure estimates were not of concern to HED
((74% cPAD); children 1-2 years old were the most highly exposed
population (see Attachment 3 for details).



Table 4:  Summary of Chronic Dietary Exposure and Risk for Novaluron. 

Population Subgroup	

cPAD (mg/kg/day)	

Exposure (mg/kg/day)	

%cPAD

General U.S. Population	

0.011	

0.002332	

21

All Infants (< 1 year old)

0.003766	

34

Children 1-2 years old

0.008146	

74

Children 3-5 years old

0.006306	

57

Children 6-12 years old

0.003837	

35

Youth 13-19 years old

0.002033	

18

Females 13-49 years old

0.001560	

14

Adults 20-49 years old

0.001662	

15

Adults 50+ years old

0.001486	

13

VI.	Characterization of Inputs/Outputs

The chronic dietary assessment was refined through the use of empirical
processing factors, some average field trial residues, and ARs for meat
and milk commodities.  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; preparation/cooking factors;
and/or ARs for poultry commodities.

VII.	Conclusions

A chronic dietary risk assessment was conducted using the DEEM-FCID(
(ver. 2.03) model.  The currently proposed commodities associated with
this petition were added (sugarcane and tomatoes at the average field
trial residue) to the last dietary assessment (which incorporated
empirical processing factors, average field trial residues, and ARs for
meat and milk commodities).  EDWC values, provided by EFED, were also
added to this dietary assessment.  The resulting food + water exposure
estimates were not of concern to HED ((74% cPAD); children 1-2 years old
were the most highly exposed population.

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.”

VIII.	List of Attachments

Attachment 1:	AR Table.

Attachment 2:	DEEM-FCID( Chronic Residue File

Attachment 3:	DEEM-FCID( Chronic Exposure Estimates

cc with all attachments:  Daniel Rosenblatt (PM Team 05; RD)

RDI: DESAC (28-JAN-2008)

G.F. Kramer:S10781:PY-S:(703)305-5079:7509P:RAB1

Attachment 1:  Processing Factors and Residue Estimates from Previous
Novaluron Dietary Assessment (Memo, G. Kramer, 22-MAR-2004; DP#298783)
Updated to Include Tomato and Sugarcane 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	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	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.

1 see 285474, G. Kramer ,22-MAR-2004

2cattle, goat, horse, and sheep

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

Attachment 2:  DEEM-FCID( Chronic Residue File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for NOVALURON                         
1994-98 data

Residue file: C:\Documents and
Settings\gkramer\GK\$Novaluron\124002c.R98

                                                               Adjust.
#2 used

Analysis Date 01-18-2008             Residue file dated:
01-18-2008/10:39:33/8

Reference dose (RfD) = 0.011 mg/kg bw/day

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

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   

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   

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   

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   

01030820 1CD  Cassava                            0.025000   1.000     
1.000   

01030821 1CD  Cassava-babyfood                   0.025000   1.000     
1.000   

05010830 5A   Cauliflower                        0.500000   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   

95001280 O    Cottonseed, oil                    0.600000   1.000     
1.000   

95001281 O    Cottonseed, oil-babyfood           0.600000   1.000     
1.000   

11001290 11   Crabapple                          0.578000   1.000     
1.000   

01031390 1CD  Dasheen, corm                      0.025000   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   

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   

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   

05011960 5A   Kohlrabi                           0.500000   1.000     
1.000   

11002100 11   Loquat                             0.833000   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   

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   

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   

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   1.000     
1.000   

01032981 1C   Potato, flour-babyfood             0.025000   1.000     
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   

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   

11003100 11   Quince                             0.833000   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   

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   

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   

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   

01033870 1CD  Turmeric                           0.025000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.002610   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.002610   1.000     
1.000   

01034060 1CD  Yam, true                          0.025000   1.000     
1.000   

01034070 1CD  Yam bean                           0.025000   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\gkramer\GK\$Novaluron\124002c.R98

                                                     Adjustment factor
#2 used.

Analysis Date 01-31-2008/09:50:25     Residue file dated:
01-31-2008/09:49:52/8

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)                     0.002332               
21.2%

U.S. Population (spring season)             0.002327               
21.2%

U.S. Population (summer season)             0.002244               
20.4%

U.S. Population (autumn season)             0.002439               
22.2%

U.S. Population (winter season)             0.002312               
21.0%

Northeast region                            0.002459               
22.4%

Midwest region                              0.002395               
21.8%

Southern region                             0.002150               
19.5%

Western region                              0.002439               
22.2%

Hispanics                                   0.002679               
24.4%

Non-hispanic whites                         0.002254               
20.5%

Non-hispanic blacks                         0.002409               
21.9%

Non-hisp/non-white/non-black                0.002552               
23.2%

All infants (< 1 year)                      0.003766               
34.2%

Nursing infants                             0.001992               
18.1%

Non-nursing infants                         0.004439               
40.4%

Children 1-6  yrs                           0.006725               
61.1%

Children 7-12 yrs                           0.003601               
32.7%

Females 13-19 (not preg or nursing)         0.001772               
16.1%

Females 20+ (not preg or nursing)           0.001462               
13.3%

Females 13-50 yrs                           0.001742               
15.8%

Females 13+ (preg/not nursing)              0.002136               
19.4%

Females 13+ (nursing)                       0.002035               
18.5%

Males 13-19 yrs                             0.002272               
20.7%

Males 20+ yrs                               0.001728               
15.7%

Seniors 55+                                 0.001484               
13.5%

Children 1-2 yrs                            0.008146               
74.1%

Children 3-5 yrs                            0.006306               
57.3%

Children 6-12 yrs                           0.003837               
34.9%

Youth 13-19 yrs                             0.002033               
18.5%

Adults 20-49 yrs                            0.001662               
15.1%

Adults 50+ yrs                              0.001486               
13.5%

Females 13-49 yrs                           0.001560               
14.2%

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

Novaluron	Dietary Exposure & Risk Assessment		DP#: 347657

PC Code:  124002

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