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%

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Novaluron	                         Dietary Exposure & Risk Assessment	                 DP#:  D359460

PC Code:  124002

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