Document ID: EPA-HQ-OPP-2009-0273-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-27T05:00Z

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:	04-DEC-2009

SUBJECT:	Novaluron.  Chronic Dietary (Food and Drinking Water) Exposure
and Risk Assessment for the Proposed Uses on Vegetable, Fruiting, Group
8; Vegetable, Cucurbit, Group 9; Berry, Low-growing, Subgroup 13-07G;
Miscellaneous Fruiting Vegetables; Bean, Snap; Bean, Dry, Seed; and
Swiss Chard.

PC Code:  124002	DP Barcode:  D364235

Decision No.:  407555	Registration No.:  66222-35-400

Petition No.:  9E7546 	Regulatory Action: Section 3 Registration

Risk Assessment Type:  Single Chemical/Aggregate	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:	Donna S. Davis, Chemist

Nancy Dodd, 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/Laura Nollen (RM 05)

Registration Division (RD; 7505P)

Executive Summary

A chronic aggregate dietary (food and drinking water) 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 Section 3 requests for use of novaluron on the fruiting
vegetable group 8; cucurbit vegetable group 9; low-growing berry
subgroup 13-07G; miscellaneous fruiting vegetables; snap bean; dry bean
seed; and Swiss chard.

Acute Dietary (Food and Drinking Water) Exposure Results and
Characterization

	

An acute dietary assessment was not conducted for novaluron because an
endpoint of concern attributable to a single dose was not identified.  

 

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

A chronic dietary (food and drinking water) exposure and risk assessment
was conducted for the proposed new uses on the fruiting vegetable group
8, cucurbit vegetable group 9, low-growing berry subgroup 13-07G,
miscellaneous fruiting vegetables, snap bean, dry bean seed, and Swiss
Chard; 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,
stone fruit, bell pepper, non-bell pepper, cucumber, summer squash,
cantaloupe, strawberry, succulent snap bean, dry bean seed, and Swiss
chard); average greenhouse trial residues for tomatoes; empirical
processing factors for apple juice (translated to pear and stone fruit)
and tomato paste and purée; and DEEM( (ver. 7.81) default processing
factors for the remaining processed commodities.  Furthermore,
anticipated residues (ARs) were used for meat, hog, and milk
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 results in a risk
estimate that is 25% of the chronic population-adjusted dose (cPAD) for
the general U.S. population and 84% of the cPAD for children 1-2 years
old, the most highly exposed population subgroup.  

Cancer Dietary (Food and Drinking Water) Exposure Results and
Characterization

A cancer dietary assessment was not conducted because novaluron is
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 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:    HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf" 
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see
SOP 99.6 (20-AUG-1999).  

The most recent dietary risk assessment for novaluron was conducted by
J. Van Alstine (09-SEP-2009, DP#359460).

II.	Food Residue Information

Novaluron Use: 

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
only.  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). 

Residue Data used for Chronic Assessments:

Recommended Tolerances:  Based on the residue chemistry data submitted
with the current petition, HED recommended for establishment of the
following tolerances for residues of the insecticide novaluron,
including its metabolites and degradates, in or on the commodities in
the table below.  Compliance with the tolerance levels specified below
is to be determined by measuring only novaluron
(N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amin
o]carbonyl]-2,6-difluorobenzamide) in or on the following raw
agricultural commodities (Memo, J. L. Van Alstine, 04-DEC-09;
DP#364237): 



Vegetable, cucurbit, group 9	0.15 ppm

	Okra	1.0 ppm

Vegetable, fruiting, group 8	1.0 ppm

	Roselle	1.0 ppm

Cocona		1.0 ppm

	Sunberry	1.0 ppm

Eggplant, African	1.0 ppm

	Tomato, bush	1.0 ppm

Eggplant, pea	1.0 ppm

	Tomato, currant	1.0 ppm

Eggplant, scarlet	1.0 ppm

	Tomato, tree	1.0 ppm

Goji berry	1.0 ppm

	Berry, low-growing, subgroup 13-07G 	0.45 ppm

Huckleberry, garden	1.0 ppm

	Bean, snap, succulent	0.60 ppm

Martynia	1.0 ppm

	Bean, dry, seed	0.30 ppm

Naranjilla	1.0 ppm

	Swiss chard	12 ppm

™ and were therefore not included in the chronic assessment: cocona,
African eggplant, pea eggplant, scarlet eggplant, goji berry, garden
huckleberry, martynia, naranjilla, roselle, sunberry, bush tomato, and
currant tomato.  However, tree tomato is included in DEEM and was
therefore included in the chronic assessment. 

	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 Sorghum,
Fruiting Vegetables (Group 8, D364309), Cucurbit Vegetables (Group 9),
Low-growing Berry Subgroup (13-07G), Snap and Dry Bean, and Swiss
Chard” (I. Maher, 16-JUL-09; DP#363989) 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.”  Since the application rates are
significantly lower for the proposed uses than for pome fruits and stone
fruits, the estimated drinking water concentrations provided in the
previous drinking water assessments dated 10-MAR-2009 (DP#357061) and
11-FEB-2004 (DP#285477) are applicable for the proposed uses.  

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 only is 0.76 ppb in surface
water.  For groundwater, the Screening Concentration in Ground Water
(SCI-GROW) model was used to predict a groundwater concentration for
novaluron.  The EDWC for novaluron only 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 RAB1 toxicologists have reevaluated the novaluron database and
reaffirmed the previous conclusion of the Hazard Identification
Assessment Review Committee (HIARC; 16-DEC-2003, TXR# 0052361) that the
Food Quality Protection Act (FQPA) Safety Factor (SF) for increased
susceptibility of infants and children can be reduced to 1X.  The
decision was based on a lack of increased susceptibility in the rat
and/or rabbit developmental toxicity studies at levels up to the limit
dose.  Also, no increased qualitative and/or quantitative evidence of
increased susceptibility was found following pre/post-natal exposure in
a two-generation reproduction study in rats.  The risk assessment team
has concluded that the FQPA SF for increased susceptibility of infants
and children can be reduced to 1X based on toxicological considerations
(above), the conservative residue assumptions used for dietary risk
assessments, the completeness of the residue chemistry database, and
conservative drinking water assessment.  Table 1 is a summary of the
decisions made by the HIARC concerning dietary exposure assessment. 
These endpoints have been confirmed by the risk assessment team as
appropriate for the current risk assessment.  

Table 1.  Summary of Toxicological Doses and Endpoints for Novaluron for
Use in Dietary Exposure Risk Assessments.

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD,
Level of Concern 	Study and Toxicological Effects

Acute Dietary (All Populations)	N/A	N/A	N/A	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	UFA = 10X

UFH = 10X

FQPA SF = 1X

	Chronic RfD = 0.011

mg/kg/day

cPAD = 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 (oral, dermal, inhalation)   	Classification: “Not likely to be
Carcinogenic to Humans.” 

Point of Departure (POD) = A data point or an estimated point that is
derived from observed dose-response data and  used to mark the beginning
of extrapolation to determine risk associated with lower environmentally
relevant human exposures.  NOAEL = no observed adverse effect level. 
LOAEL = lowest observed adverse effect level.  UF = uncertainty factor. 
UFA = extrapolation from animal to human (interspecies).  UFH =
potential variation in sensitivity among members of the human population
(intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population
adjusted dose (a = acute, c = chronic).  RfD = reference dose.  N/A =
not applicable.

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).  The chronic dietary exposure estimates are 25% of
the chronic population-adjusted dose (cPAD) for the general U.S.
population and 84% of the cPAD for children 1-2 years old, the most
highly exposed population subgroup (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	0.002749	25	N/A	N/A

All Infants (< 1 year old)

	0.004732	43

Children 1-2 years old

	0.009204	84

Children 3-5 years old

	0.007142	65

Children 6-12 years old

	0.004307	39

Youth 13-19 years old

	0.002365	22

Adults 20-49 years old

	0.001944	18

Adults 50+ years old

	0.001965	18

Females 13-49 years old

	0.001856	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, stone fruit, bell pepper,
non-bell pepper, cucumber, summer squash, cantaloupe, strawberry,
succulent snap bean, dry bean seed, and Swiss chard), average greenhouse
trial residues for tomatoes, and ARs for meat, hog, 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 SOP 2000.1, average field trial residues were
translated from representative commodities in the crop group to other
commodities in that crop group as needed (see Appendix 1).  Despite
this, HED concludes that the chronic estimates are still highly
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 percent 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 bell
pepper, non-bell pepper, cucumber, summer squash, cantaloupe,
strawberry, succulent snap bean, dry bean seed, and Swiss chard were
added to the last dietary assessment.  The last dietary assessment
incorporated empirical processing factors, average field trial residues
(pome fruit, sugarcane, bushberries, Brassica leafy greens, and stone
fruit), average greenhouse trial residues (tomatoes), and ARs for meat
and milk commodities.  EDWC values, provided by EFED, were included in
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 84% of the cPAD for children 1-2 years old, the most highly exposed
population subgroup.  

X.	List of Attachments

Attachment 1:	AR Table.

Attachment 2:	DEEM-FCID( Chronic Residue Input File.

Attachment 3:	DEEM-FCID( Chronic Results File.

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 Assessments (Memo, G. Kramer, 22-MAR-2004, DP#298783;
Memo, J. Van Alstine, 09-SEP-2009, DP#359460) Updated to Include
Proposed Commodity Processing Factors and Residue Estimates.

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, crabapple3	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 fruit3	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, tomatillo, tree tomato4	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.

bell pepper, eggplant5	RAC	1	0.14	average bell pepper field trial
residue

non-bell pepper, okra6	RAC	1	0.16	average non-bell pepper 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	1	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.

cucumber, Chinese waxgourd, balsam pear8	All	1	0.05	average cucumber
field trial residue

cantaloupe, casaba, honeydew melon, winter melon, watermelon9	RAC	1
0.055	average cantaloupe field trial residue

	juice	1	0.055	average cantaloupe field trial residue

summer squash, chayote fruit Christophe, pumpkin, winter squash10	All	1
0.044	average summer squash field trial residue

bushberry subgroup 13-07B11	All	1	1.97	average blueberry field trial
residue

low-growing berry subgroup 13-07G12	All	1	0.140	average strawberry field
trial residue; DEEM (ver. 7.78) default proc. fact. of 1.1 used for
cranberry juice

snap bean (succulent)	All	1	0.18	average succulent snap bean pods with
seeds field trial residue

dry bean seed	All	1	0.065	average dry bean seed field trial residue

Swiss chard	All	1	4.2	average Swiss chard field trial residue

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 Tomato residues were translated to tomatillo and tree tomato using HED
SOP 2000.1.

5 Bell pepper residues were translated to eggplant using HED SOP 2000.1.

6 Non-bell pepper residues were translated to okra.

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

8 Cucumber residues were translated to Chinese waxgourd and balsam pear
using HED SOP 2000.1.

9 Cantaloupe residues were translated to casabas, honeydew melon, winter
melon, and watermelon using HED SOP 2000.1.

10 Summer squash residues were translated to chayote fruit Christophe,
pumpkin, and winter squash using HED SOP 2000.1.

11 Blueberry residues were translated to currant, elderberry,
gooseberry, and huckleberry using the memo titled “ChemSAC Review of
USDA IR-4 Crop Grouping Proposal to Amend the Berry Crop Group 13” (B.
Schneider, 28-MAR-2006).

12 Strawberry residues were translated to cranberry using the memo
titled “ChemSAC Review of USDA IR-4 Crop Grouping Proposal to Amend
the Berry Crop Group 13” (B. Schneider, 28-MAR-2006).

Attachment 2:  DEEM-FCID( Chronic Residue Input File

Filename: C:\Documents and Settings\jlangsda\My
Documents\Chemicals\Novaluron\Pepper, Strawberry, Snap Bean, Cucumber,
etc\DEEM\124002-chronic-2009-JLV__10-NOV-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
 

04023670 4B   Swiss chard                        4.200000   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
 

06010430 6A   Bean, snap, succulent              0.180000   1.000  1.000
 

06010431 6A   Bean, snap, succulent-babyfood     0.180000   1.000  1.000
 

06030320 6C   Bean, broad, seed                  0.065000   1.000  1.000
 

06030340 6C   Bean, cowpea, seed                 0.065000   1.000  1.000
 

06030350 6C   Bean,  great northern, seed        0.065000   1.000  1.000
 

06030360 6C   Bean, kidney, seed                 0.065000   1.000  1.000
 

06030380 6C   Bean, lima, seed                   0.065000   1.000  1.000
 

06030390 6C   Bean, mung, seed                   0.065000   1.000  1.000
 

06030400 6C   Bean, navy, seed                   0.065000   1.000  1.000
 

06030410 6C   Bean, pink, seed                   0.065000   1.000  1.000
 

06030420 6C   Bean, pinto, seed                  0.065000   1.000  1.000
 

06030980 6C   Chickpea, seed                     0.065000   1.000  1.000
 

06030981 6C   Chickpea, seed-babyfood            0.065000   1.000  1.000
 

06030990 6C   Chickpea, flour                    0.065000   1.000  1.000
 

08001480 8    Eggplant                           0.140000   1.000  1.000
 

08002340 8    Okra                               0.160000   1.000  1.000
 

08002700 8    Pepper, bell                       0.140000   1.000  1.000
 

08002701 8    Pepper, bell-babyfood              0.140000   1.000  1.000
 

08002710 8    Pepper, bell, dried                0.140000   1.000  1.000
 

08002711 8    Pepper, bell, dried-babyfood       0.140000   1.000  1.000
 

08002720 8    Pepper, nonbell                    0.160000   1.000  1.000
 

08002721 8    Pepper, nonbell-babyfood           0.160000   1.000  1.000
 

08002730 8    Pepper, nonbell, dried             0.160000   1.000  1.000
 

08003740 8    Tomatillo                          0.161000   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
 

09010750 9A   Cantaloupe                         0.055000   1.000  1.000
 

09010800 9A   Casaba                             0.055000   1.000  1.000
 

09011870 9A   Honeydew melon                     0.055000   1.000  1.000
 

09013990 9A   Watermelon                         0.055000   1.000  1.000
 

09014000 9A   Watermelon, juice                  0.055000   1.000  1.000
 

09020210 9B   Balsam pear                        0.050000   1.000  1.000
 

09020880 9B   Chayote, fruit                     0.044000   1.000  1.000
 

09021020 9B   Chinese waxgourd                   0.050000   1.000  1.000
 

09021350 9B   Cucumber                           0.050000   1.000  1.000
 

09023080 9B   Pumpkin                            0.044000   1.000  1.000
 

09023090 9B   Pumpkin, seed                      0.044000   1.000  1.000
 

09023560 9B   Squash, summer                     0.044000   1.000  1.000
 

09023561 9B   Squash, summer-babyfood            0.044000   1.000  1.000
 

09023570 9B   Squash, winter                     0.044000   1.000  1.000
 

09023571 9B   Squash, winter-babyfood            0.044000   1.000  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
 

95001300 O    Cranberry                          0.140000   1.000  1.000
 

95001301 O    Cranberry-babyfood                 0.140000   1.000  1.000
 

95001310 O    Cranberry, dried                   0.140000   1.000  1.000
 

95001320 O    Cranberry, juice                   0.140000   1.100  1.000
 

95001321 O    Cranberry, juice-babyfood          0.140000   1.100  1.000
 

95003590 O    Strawberry                         0.140000   1.000  1.000
 

95003591 O    Strawberry-babyfood                0.140000   1.000  1.000
 

95003600 O    Strawberry, juice                  0.140000   1.000  1.000
 

95003601 O    Strawberry, juice-babyfood         0.140000   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
 

95003800 O    Tomato, Tree                       0.161000   1.000  1.000
 

Attachment 3:  DEEM-FCID( Chronic Results File

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\Pepper, Strawberry, Snap Bean, Cucumber,
etc\DEEM\124002-chronic-2009-JLV__10-NOV-09.R98

                                                     Adjustment factor
#2 used.

Analysis Date 11-10-2009/16:30:36     Residue file dated:
11-10-2009/16:29:35/8

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)                     0.002749               
25.0%

U.S. Population (spring season)             0.002724               
24.8%

U.S. Population (summer season)             0.002798               
25.4%

U.S. Population (autumn season)             0.002823               
25.7%

U.S. Population (winter season)             0.002639               
24.0%

Northeast region                            0.002840               
25.8%

Midwest region                              0.002775               
25.2%

Southern region                             0.002616               
23.8%

Western region                              0.002850               
25.9%

Hispanics                                   0.002945               
26.8%

Non-hispanic whites                         0.002580               
23.5%

Non-hispanic blacks                         0.003328               
30.3%

Non-hisp/non-white/non-black                0.003396               
30.9%

All infants (< 1 year)                      0.004732               
43.0%

Nursing infants                             0.002662               
24.2%

Non-nursing infants                         0.005518               
50.2%

Children 1-6  yrs                           0.007618               
69.3%

Children 7-12 yrs                           0.004024               
36.6%

Females 13-19 (not preg or nursing)   
††〠〮㈰㔰‶†††††††ㄠ⸸┷䘍浥污獥㈠⬰⠠
潮⁴牰来漠⁲畮獲湩⥧†††††〠〮㄰㐸″††††
†††ㄠ⸶┸䘍浥污獥ㄠⴳ〵礠獲†††††††††
††††〠〮㈰㐰″†††††††ㄠ⸸┶

 

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Females 13+ (preg/not nursing)              0.002370               
21.5%

Females 13+ (nursing)                       0.002357               
21.4%

Males 13-19 yrs                             0.002654               
24.1%

Males 20+ yrs                               0.002054               
18.7%

Seniors 55+                                 0.001996               
18.1%

Children 1-2 yrs                            0.009204               
83.7%

Children 3-5 yrs                            0.007142               
64.9%

Children 6-12 yrs                           0.004307               
39.2%

Youth 13-19 yrs                             0.002365               
21.5%

Adults 20-49 yrs                            0.001944               
17.7%

Adults 50+ yrs                              0.001965               
17.9%

Females 13-49 yrs                           0.001856               
16.9%

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

Novaluron	                         Dietary Exposure & Risk Assessment	  
              DP#:  364235

PC Code:  124002

 PAGE   

Page   PAGE  7  of   NUMPAGES  15