Novaluron Dietary Exposure & Risk Assessment DP#: 364235

PC Code: 124002

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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)
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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.”
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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: http://www.epa.gov/fedrgstr/EPAPEST/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-SEP2009, 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-FEB04; 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]amino]carbonyl]-2,6-difluorobenzamide) in or on the following 

raw agricultural commodities (Memo, J. L. Van Alstine, 04-DEC-09; DP#364237):
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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

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, 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 Standard Operating Procedure (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). The following fruiting vegetables 

are not listed in DEEM-FCID

TM 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. 

III. 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), Lowgrowing 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 
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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-FCIDTM Program and Consumption Information

A novaluron chronic dietary exposure assessment was conducted using DEEM-FCIDTM, 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 EPAdefined 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 foodform (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 
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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 DEEMFCID 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 
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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 
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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
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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.

fat2fat 1 2.43 AR

liver2liver 1 0.190 AR

kidney2kidney 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 1⁄2 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.
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crop commodity

processing

factor1

residue 

(ppm)

1

comment

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-MAR2006).
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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 
Novaluron Dietary Exposure & Risk Assessment DP#: 364235

PC Code: 124002

Page 12 of 15

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 
Novaluron Dietary Exposure & Risk Assessment DP#: 364235

PC Code: 124002

Page 13 of 15

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 
Novaluron Dietary Exposure & Risk Assessment DP#: 364235

PC Code: 124002

Page 14 of 15

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 
Novaluron Dietary Exposure & Risk Assessment DP#: 364235

PC Code: 124002

Page 15 of 15

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) 0.002056 18.7%

Females 20+ (not preg or nursing) 0.001843 16.8%

Females 13-50 yrs 0.002043 18.6%

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%

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