Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 1 of 26

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE: 23-FEB-2010

SUBJECT: Novaluron. Chronic Dietary (Food and Drinking Water) Exposure and Risk 

Assessment for the Proposed Use in/on Grain Sorghum. 

PC Code: 124002 DP Barcode: D374419

Decision No.: 407899 Registration No.: 66222-35-400

Petition No.: 9F7547 Regulatory Action: Section 3 Registration

Risk Assessment Type: Dietary Exposure 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: William Cutchin, Chemist

Tom Bloem, 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

John Hebert (RM 07)/ Jennifer Gaines

Registration Division (RD; 7505P)
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 2 of 26

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 a Section 3 request

for use of novaluron on grain sorghum.

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 use on grain sorghum, all established uses, and drinking water. A partially refined 

assessment was conducted. EFED provided the estimated drinking water concentrations 

(EDWCs) which were incorporated into the analysis. A Screening Level Usage Analysis 

(SLUA) memorandum for existing uses and a percent crop treated for new use (PCTn) 

memorandum for sorghum were provided by the Biological and Economic Analysis Division 

(BEAD). The chronic analysis incorporated average percent crop treated (%CT) data for apples, 

cabbage, cotton, pears, and potatoes and PCTn data for grain sorghum. 100% CT was assumed 

for the remaining food commodities. Anticipated residues (ARs) for meat, milk, hog, and 

poultry commodities were calculated using PCTn for grain sorghum, average %CT for apple and 

cotton, and assumed 100% CT for sugarcane. The chronic analysis also 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 juice) and tomato paste and purée; and DEEM (ver. 7.81) default processing factors for 

the remaining processed 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 11% of the chronic population-adjusted dose (cPAD)

for the general U.S. population and 32% 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.”
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 3 of 26

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 (04-

DEC-2009, DP#364235).

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 listed 

below (Memo, J. L. Van Alstine, 23-FEB-2010; DP# 374420):

Grain, aspirated fractions 25 ppm Poultry, fat 7.0 ppm

Sorghum, grain, grain 3.0 ppm Egg 1.5 ppm

Sorghum, grain, forage 6.0 ppm Hog, meat 0.07 ppm

Sorghum, grain, stover 40 ppm Hog, liver 0.10 ppm

Poultry, meat 0.40 ppm Hog, kidney 0.10 ppm

Poultry, liver 0.80 ppm Hog, meat byproducts 0.10 ppm

Poultry, kidney 0.80 ppm Hog, fat 1.5 ppm

Poultry, meat byproducts 0.80 ppm
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 4 of 26

Residues used in the Chronic Analysis: The current chronic dietary analysis incorporated average 

%CT data for apples, cabbage, cotton, pears, and potatoes; PCTn for grain sorghum; and 

assumed 100% CT for the remaining commodities. The chronic dietary analysis was refined 

through the use of 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 calculated ARs for meat, milk, hog, and poultry commodities. 

Empirical processing factors for apple juice (translated to pear and stone fruit juice) and tomato 

paste and purée were utilized along with DEEM (ver. 7.81) default processing factors for the 

remaining processed commodities. 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). 

Attachment 1 summarizes the ARs, processing factors, average field trial residues, and %CT data 

which were incorporated into the current analysis. A summary of the %CT and PCTn estimates 

provided by BEAD are presented in Attachments 4 and 5. 

Calculation of ARs in Meat, Milk, Poultry, and Eggs

Residue Chemistry Memo, DP# 285474, 3/22/1004, G.F. Kramer (PP#2F6430)

Residue Chemistry Memo, DP# 315890, 5/10/2005, G.F. Kramer (PP#2F6430)

Residue Chemistry Memo, DP# 336897, 1/31/2008, S. J. Levy (PP#2F06430)

The potential for secondary transfer of novaluron residues of concern in meat, milk, and eggs 

exists because there are livestock feedstuffs associated with the proposed/registered novaluron

uses. The livestock dietary burdens of novaluron are presented in Table 1 and are based on the 

proposed/registered uses, tolerance-level residues, and %CT and PCTn data from BEAD. The 

reasonably balanced dietary burdens (RBDBs) reflect the most recent guidance from HED 

(OPPTS 860.1000 Supplement, Table 1 Feedstuffs, 30-JUN-2008) concerning revisions of 

feedstuff percentages and constructing RBDBs. 

Table 1. Calculation of Dietary Burdens of Novaluron Residues to Livestock1.

Feedstuff Type2 % Dry 

Matter

3

% 

Diet3

HED Recommended 

Tolerance (ppm)

Average

% Crop 

Treated

Dietary 

Contribution 

(ppm)

4

Beef Cattle

Sorghum, grain, stover R 88 15 40.0 5

5

0.34

Sorghum, grain, grain CC 86 35 3.0 5

5

0.061

Sugarcane, molasses CC 75 5 0.5 10060.033

Grains, aspirated fractions CC 85 5 25 5

5,7 0.074

Untreated CC -- 35 -- -- --

Cottonseed, meal PC 89 5 0.60 2.580.00084

TOTAL BURDEN -- -- 100 -- -- 0.51

Dairy Cattle9
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 5 of 26

Table 1. Calculation of Dietary Burdens of Novaluron Residues to Livestock1.

Feedstuff Type2 % Dry 

Matter

3

% 

Diet3

HED Recommended 

Tolerance (ppm)

Average

% Crop 

Treated

Dietary 

Contribution 

(ppm)

4

Sorghum, grain, forage R 35 40 6.0 5

5

0.34

Sorghum, grain, stover R 88 5 40.0 5

5

0.11

Sorghum, grain, grain CC 86 35 3.0 5

5

0.061

Apple, wet pomace CC 40 10 8.0 1580.30

Cotton, undelinted seed PC 88 10 0.60 2.580.0017

TOTAL BURDEN -- -- 100 -- -- 0.81

Poultry

Sorghum, grain, grain CC 86 75 3.0 5

5

0.11

Cottonseed, meal PC 89 20 0.60 2.580.003

Untreated PC -- 5 -- -- --

TOTAL BURDEN -- -- 100 -- -- 0.11

Swine

Sorghum, grain, grain CC 86 80 3.0 5

5

0.12

Untreated CC -- 5 -- -- --

Cottonseed, meal PC 89 15 0.60 2.580.0022

TOTAL BURDEN -- -- 100 -- -- 0.12

1 Original table (without %CT and PCTn) prepared by Jerry Stokes; 29-OCT-2009. 

2 R: roughage; CC: carbohydrate concentrate; PC: protein concentrate.

3 OPPTS 860.1000 Table 1 Feedstuffs (June 2008). 

4 Contribution = ([tolerance /% DM] X % diet X %CT) for beef and dairy cattle; contribution = ([tolerance] X % diet X %CT) 

for poultry and swine.

5

PCTn from BEAD memo (C. Doucoure et al., 29-DEC-09; D371615).

6 No %CT data was available for sugarcane, so 100% crop treated was assumed.

7

Sorghum is currently the only source of novaluron residues for AGF. This value may change if tolerances are established for 

other grain commodities which may be processed into AGF. 

8 Average %CT from SLUA memo (A. Grube, 17-NOV-09; D371221).

9

Petition 8E7425 (Memo, J. Van Alstine, 09-SEP-2009; D357060) included a request for the use of novaluron on turnip greens; 

HED requested that the petitioner submit a new label which prohibits the use of novaluron on turnips harvested for the root 

and prohibits the feeding of turnip tops to livestock. 

Expected secondary residues in meat and milk

The anticipated secondary residues in cattle matrices were estimated using average transfer 

coefficients calculated from the maximum residues of novaluron observed at the 3.9-, 12.6-, and 

42.8-ppm dose levels (PP#2F6430). The transfer coefficients (calculated as residue-level-to-feed 

ratios) are presented in Table 2. The transfer coefficient for each matrix was then used to 

calculate the expected secondary residues by multiplying the average transfer coefficient by the 

calculated dietary burden (Tables 3 and 4). 

Table 2. Residue-Level-to-Feed Ratios (Transfer Coefficients) in Dairy Cattle Milk and Tissues.

Matrix Maximum Residues (ppm) Feeding Levels (ppm) Transfer Coefficients (Average)

Whole milk 0.17, 0.43, 2.07

3.9, 12.6, 42.8

0.044, 0.034, 0.048, (0.042)

Muscle 0.09, 0.34, 0.56 0.023, 0.027, 0.013, (0.021)

Kidney 0.14, 0.35, 1.20 0.036, 0.028, 0.028, (0.031)

Liver 0.14, 0.41, 1.36 0.036, 0.033, 0.032, (0.034)

Fat (peritoneal) 2.25, 6.83, 12.89 0.577, 0.542, 0.301, (0.473)
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 6 of 26

Table 3. Expected Secondary Residues in Cattle Meat and Milk.

Matrix Dietary burden (ppm) Anticipated Secondary Residues (ppm)1

Whole milk

0.81

0.034

Muscle 0.017

Kidney 0.025

Liver 0.027

Fat (peritoneal) 0.39

1 Calculated from dietary burden x average transfer coefficient from Table 2 (using non-truncated values). 

Table 4. Expected Secondary Residues in Hog Meat.

Matrix Dietary burden (ppm) Anticipated Secondary Residues (ppm)1

Muscle

0.12

0.0026

Kidney 0.0037

Liver 0.0041

Fat (peritoneal) 0.058

1 Calculated from dietary burden x average transfer coefficient from Table 2 (using non-truncated values).

2

In 40 CFR §180.598, the tolerance is for hog, meat byproducts. 

 

Expected secondary residues in poultry meat and eggs

The anticipated secondary residues in poultry matrices were estimated using average transfer 

coefficients calculated from the maximum residues of novaluron observed in the hen metabolism 

study (0.12-, 0.36-, 1.2-ppm dose levels; PP#2F06430). The transfer coefficients (calculated as 

residue-level-to-feed ratios) are presented in Table 5. The transfer coefficient for each matrix 

was then used to calculate the expected secondary residues by multiplying the average transfer 

coefficient by the calculated dietary burden (Table 6). 

Table 5. Residue-Level-to-Feed Ratios (Transfer Coefficients) in Poultry Eggs and Tissues.

Matrix Maximum 

Residues (ppm) Feeding Levels (ppm) Transfer Coefficients (Average)

Eggs (day 54) 0.063, 0.181, 0.702

0.12, 0.36, 1.2

0.53, 0.50, 0.59, (0.54)

Muscle 0.014, 0.031, 0.160 0.12, 0.09, 0.13, (0.11)

Liver 0.034, 0.096, 0.364 0.28, 0.27, 0.30, (0.28)

Kidney 0.039, 0.089, 0.368 0.33, 0.25, 0.31, (0.29)

Fat (abdominal) 0.323, 0.988, 3.011 2.7, 2.7, 2.5, (2.6)

Table 6. Expected Secondary Residues in Poultry Meat and Eggs.

Matrix Dietary burden (ppm) Anticipated Secondary Residues (ppm)1

Eggs (day 54)

0.11

0.062

Muscle 0.013

Liver 0.0332

Kidney 0.0342

Fat (abdominal) 0.31

1 Calculated from dietary burden x average transfer coefficient from Table 5 (using non-truncated values). 

2

In 40 CFR §180.598, the tolerance is for hog, meat byproducts. 
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 7 of 26

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 

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

A SLUA memorandum entitled, “Usage Report Package in Support of Registration for the 

Insecticide Novaluron (124002), BEAN DP# 371221” (A. Grube, 17-NOV-2009) and a PCTn 

memorandum entitled, “Percent Crop Treated for New Use (PCTn): Novaluron (124002) Use on 

Sorghum, DP# 371615” (C. Doucoure et al., 29-DEC-2009) were provided by BEAD. The 
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 8 of 26

SLUA memo included %CT data for apples, cabbage, cotton, pears, and potatoes. The market 

leader approach was used by BEAD to determine the PCTn for sorghum. 

The chronic dietary analysis incorporated average %CT data for apples (15%), cabbage (10%), 

cotton (2.5%), pears (10%), and potatoes (2.5%) and PCTn data for grain sorghum (5%). 100% 

CT was assumed for the remaining food commodities. Livestock dietary burdens of novaluron

were calculated based on the proposed/registered uses, tolerance-level residues, and PCTn data 

for grain sorghum (5%), average %CT data for apple (15%) and cotton (2.5%), and 100% CT for 

sugarcane. These livestock dietary burdens were used, along with average transfer coefficients, 

to calculate anticipated secondary residues for meat, milk, hog, and poultry commodities which 

were incorporated into the chronic dietary assessment. 

Attachment 1 summarizes the %CT data utilized in the chronic dietary assessment. Please refer 

to Attachments 4 and 5 for the %CT and PCTn memorandums provided by BEAD. 

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 

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 
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 9 of 26

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 7 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 7. 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 = populationadjusted 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 8 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 years old. The resulting food and drinking water exposure estimates were 

not of concern to HED (100% cPAD). The chronic dietary exposure estimates are 11% of the 

cPAD for the general U.S. population and 32% of the cPAD for children 1-2 years old, the most 

highly exposed population subgroup (see Attachment 3 for details).
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 10 of 26

Table 8. 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

0.001206 11

N/A N/A

All Infants (< 1 year old) 0.001955 18

Children 1-2 years old 0.003537 32

Children 3-5 years old 0.002771 25

Children 6-12 years old 0.001700 16

Youth 13-19 years old 0.001021 9

Adults 20-49 years old 0.000884 8

Adults 50+ years old 0.001027 9

Females 13-49 years old 0.000874 8

VIII. Characterization of Inputs/Outputs

The chronic dietary assessment was refined through the use of 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, milk, hog, 

and poultry commodities. Empirical processing factors for apple juice (translated to pear and 

stone fruit juice) and tomato paste and purée were utilized along with DEEM (ver. 7.81) 

default processing factors for the remaining processed commodities. 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]. The current chronic dietary analysis also 

incorporated average %CT data for apples, cabbage, cotton, pears, and potatoes and average 

PCTn for sorghum. 100% CT was assumed for the remaining commodities. ARs for meat, milk, 

hog, and poultry commodities were calculated using PCTn for sorghum, average %CT for apple 

and cotton, and 100% CT for sugarcane. The current chronic analysis could be further refined 

through the use of monitoring data and preparation/cooking factors. 

IX. Conclusions

A chronic dietary risk assessment was conducted using DEEM-FCID (ver. 2.03). Updated 

ARs for meat, milk, hog, and poultry commodities were incorporated into the chronic dietary risk 

assessment along with %CT data provided by BEAD. 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 11% of the cPAD for the general U.S. 

population and 32% of the cPAD for children 1-2 years old, the most highly exposed population 

subgroup. 
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 11 of 26

X. List of Attachments

Attachment 1: Processing Factor, AR, and Average Field Trial Residue Table.

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

Attachment 3: DEEM-FCID Chronic Results File.

Attachment 4: Usage Report Package in Support of Registration for the Insecticide Novaluron 

(124002), BEAN DP# 371221 (Memo, A. Grube, 17-NOV-2009).

Attachment 5: Percent Crop Treated for New Use (PCTn): Novaluron (124002) Use on 

Sorghum, DP# 371615 (Memo, C. Doucoure et al., 29-DEC-2009).

cc: Julie L. Van Alstine

J.L.Van Alstine:S-10954:PY-S:(703)603-8866:7509P:RAB1
Novaluron Dietary Exposure & Risk Assessment DP#: D374419 PC Code: 124002

Page 12 of 26

Attachment 1: Processing Factors and Residue Estimates from Previous Novaluron Dietary Assessments1 Updated to Include Current ARs for Meat, Milk, Hog, and 

Poultry Commodities and %CT.

Crop Commodity Processing

Factor

Residue 

(ppm)

1

Average 

%CT

Comment

meat2 meat 1 0.017 100% AR

dried beef meat dried meat 1.92 0.017 100% AR; DEEM (ver. 7.78) default proc. fact.

fat2(peritoneal) fat 1 0.39 100% AR

liver2liver 1 0.027 100% AR

kidney2kidney 1 0.025 100% AR

meat byproducts except liver and kidney2 meat byproducts 1 0.027 100% AR (meat liver)

milk

Milk, fat 1 0.85 100% AR, calculated assuming residues partition into fat [whole milk secondary residue x 25 

(maximum concentration factor for milk fat)]

Milk, nonfat solids 1 0.034 100% AR for whole milk, used to account for low residues observed in skim milk

Milk, water 1 0 100% All residues assumed to be associated with fat and solids

Milk, sugar 1 0 100% All residues assumed to be associated with fat and solids

pork meat meat 1 0.0026 100% AR

pork skin skin 1 0.058 100% AR (pork peritoneal fat)

pork fat (peritoneal) fat 1 0.058 100% AR

pork liver liver 1 0.0041 100% AR

pork kidney kidney 1 0.0037 100% AR

pork meat byproducts meat byproducts 1 0.0041 100% AR (pork liver)

poultry meat meat 1 0.013 100% AR

poultry liver liver 1 0.033 100% AR

poultry kidney kidney 1 0.034 100% AR

poultry meat byproducts meat byproducts 1 0.034 100% AR (poultry kidney)

poultry fat (abdominal) fat 1 0.31 100% AR

poultry skin skin 1 0.31 100% AR (poultry abdominal fat)

egg RAC 1 0.062 100% AR

cotton cottonseed oil 1 0.60 <2.5% tolerance for RAC adequate to cover residues in processed commodity; average %CT for 

cotton from SLUA memo (A. Grube, 17-NOV-09; D371221)

tuberous and corm vegetables All 1 0.025 <2.5% 1⁄2 LOQ residue; DEEM (ver. 7.78) default proc. factor of 6.5 used for potato, dry; 

average %CT assumed for potato only (SLUA; A. Grube, 17-NOV-09; D371221)

pome fruit – apple, crabapple3

RAC, sauce 1 0.578 15% average field trial residue; average %CT assumed for apple only (SLUA; A. Grube, 17-

NOV-09; D371221)

dried 8 0.578 15% average field trial residue; DEEM (ver. 7.78) default proc. fact.; average %CT assumed 

for apple only (SLUA; A. Grube, 17-NOV-09; D371221)

juice 0.10 0.578 15% average field trial residue; empirical proc. fact.; average %CT assumed for apple only 

(SLUA; A. Grube, 17-NOV-09; D371221)

pome fruit – pear + other pome fruit3 RAC 1 0.833 10% average field trial residue; average %CT assumed for pear only (SLUA; A. Grube, 17-

NOV-09; D371221)
Novaluron Dietary Exposure & Risk Assessment DP#: D374419 PC Code: 124002

Page 13 of 26

Crop Commodity Processing

Factor

Residue 

(ppm)

1

Average 

%CT

Comment

dried 6.25 0.833 10% average field trial residue; DEEM (ver. 7.78) default proc. fact.; average %CT assumed

for pear only (SLUA; A. Grube, 17-NOV-09; D371221)

juice 0.10 0.833 10% average field trial residue; empirical apple proc. fact.; average %CT assumed for pear 

only (SLUA; A. Grube, 17-NOV-09; D371221)

sugarcane

sugar 1 0.125 100% average field trial residue

molasses 1 0.125 100% average field trial residue

tomato, tomatillo, tree tomato4

RAC 1 0.161 100% overall (small- & large-fruit varieties) average of the greenhouse trial residue.

dried 14.3 0.161 100% overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. fact.

juice 1.5 0.161 100% overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. fact.

purée 0.7 0.161 100% overall average of the greenhouse trial residue; empirical proc. fact.

paste 1.1 0.161 100% overall average of the greenhouse trial residue; empirical proc. fact.

bell pepper, eggplant5 RAC 1 0.14 100% average bell pepper field trial residue

non-bell pepper, okra6 RAC 1 0.16 100% average non-bell pepper field trial residue

Brassica, leafy greens, subgroup 5B and 

turnip, greens All 1 5.33 100% average mustard green field trial residue

plum 

RAC 1 0.403 100% average plum field trial residue

dried 1 2.6 100% tolerance for dried plum

juice 0.10 0.403 100% average plum field trial residue; empirical apple proc. fact.

cherry RAC 1 2.17 100% average field trial residue

juice 0.10 2.17 100% average field trial residue; empirical apple proc. fact.

peach, nectarine, and apricot7

RAC 1 0.61 100% average peach field trial residue

dried (peach) 7.0

0.61 100% average peach field trial residue; DEEM (ver. 7.78) default proc. fact. of 7.0 used for 

dried (apricot) 6.0 peaches, dried and 6.0 used for apricots, dried

juice 0.10 0.61 100% average peach field trial residue; empirical apple proc. fact.

cucumber, Chinese waxgourd, balsam 

pear8 All 1 0.05 100% average cucumber field trial residue

cantaloupe, casaba, honeydew melon, 

winter melon, watermelon9

RAC 1 0.055 100% average cantaloupe field trial residue

juice 1 0.055 100% average cantaloupe field trial residue

summer squash, chayote fruit Christophe, 

pumpkin, winter squash10 All 1 0.044 100% average summer squash field trial residue

bushberry subgroup 13-07B11 All 1 1.97 100% average blueberry field trial residue

low growing berry subgroup 13-07G

(except lowbush blueberry)12 All 1 0.140 100% average strawberry field trial residue; DEEM (ver. 7.78) default proc. fact. of 1.1 used for cranberry juice

snap bean (succulent) All 1 0.18 100% average succulent snap bean pods with seeds field trial residue

dry bean seed All 1 0.065 100% average dry bean seed field trial residue

Swiss chard All 1 4.2 100% average Swiss chard field trial residue

Brassica, head and steam, subgroup 5A All 1 0.50 10% tolerance level residue; average %CT assumed for cabbage only (SLUA; A. Grube, 17-

NOV-09; D371221)
Novaluron Dietary Exposure & Risk Assessment DP#: D374419 PC Code: 124002

Page 14 of 26

Crop Commodity Processing

Factor

Residue 

(ppm)

1

Average 

%CT

Comment

Sorghum, grain grain 1 3.0 5% tolerance level residue; average %CT assumed for grain only (PCTn memo; C. Doucoure 

et al., 29-DEC-2009, D371615

1 Memo, G. Kramer, 22-MAR-2004 DP#285474; Memo, G. Kramer, 22-MAR-2004, DP#298783; Memo, G. Kramer, 07-FEB-2008, DP#347657; Memo, J. Van Alstine, 09-SEP-2009, 

DP#359460; Memo, J. Van Alstine, 04-DEC-2009, DP#364235.

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).
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 15 of 26

Attachment 2: DEEM-FCID Chronic Residue Input File

Filename: C:\Documents and Settings\jlangsda\My 

Documents\Chemicals\Novaluron\Sorghum\DEEM\Sent to Reviewers\124002-chronic-2009-JLV__04-

FEB-10.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: 02-05-2010/07:35:49/8 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 0.025 

01032970 1C Potato, dry (granules/ flakes) 0.025000 6.500 0.025 

01032971 1C Potato, dry (granules/ flakes)-b 0.025000 6.500 0.025 

01032980 1C Potato, flour 0.025000 6.500 0.025 

01032981 1C Potato, flour-babyfood 0.025000 6.500 0.025 

01032990 1C Potato, tuber, w/peel 0.025000 1.000 0.025 

01032991 1C Potato, tuber, w/peel-babyfood 0.025000 1.000 0.025 

01033000 1C Potato, tuber, w/o peel 0.025000 1.000 0.025 

01033001 1C Potato, tuber, w/o peel-babyfood 0.025000 1.000 0.025 

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 0.100 

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 

06030300 6C Bean, black, seed 0.065000 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 

06031820 6C Guar, seed 0.065000 1.000 1.000 

06031821 6C Guar, seed-babyfood 0.065000 1.000 1.000 

06032030 6C Lentil, seed 0.065000 1.000 1.000 

06032560 6C Pea, dry 0.065000 1.000 1.000 

06032561 6C Pea, dry-babyfood 0.065000 1.000 1.000 
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 16 of 26

06032580 6C Pea, pigeon, seed 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 0.150 

11000080 11 Apple, peeled fruit 0.578000 1.000 0.150 

11000081 11 Apple, peeled fruit-babyfood 0.578000 1.000 0.150 

11000090 11 Apple, dried 0.578000 8.000 0.150 

11000091 11 Apple, dried-babyfood 0.578000 8.000 0.150 

11000100 11 Apple, juice 0.578000 0.100 0.150 

11000101 11 Apple, juice-babyfood 0.578000 0.100 0.150 

11000110 11 Apple, sauce 0.578000 1.000 0.150 

11000111 11 Apple, sauce-babyfood 0.578000 1.000 0.150 

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 0.100 

11002661 11 Pear-babyfood 0.833000 1.000 0.100 

11002670 11 Pear, dried 0.833000 6.250 0.100 

11002680 11 Pear, juice 0.833000 0.100 0.100 

11002681 11 Pear, juice-babyfood 0.833000 0.100 0.100 

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 
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 17 of 26

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 

15003440 15 Sorghum, grain 3.000000 1.000 0.050 

21000440 M Beef, meat 0.017000 1.000 1.000 

21000441 M Beef, meat-babyfood 0.017000 1.000 1.000 

21000450 M Beef, meat, dried 0.017000 1.920 1.000 

21000460 M Beef, meat byproducts 0.027000 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.027000 1.000 1.000 

21000470 M Beef, fat 0.390000 1.000 1.000 

21000471 M Beef,fat-babyfood 0.390000 1.000 1.000 

21000480 M Beef, kidney 0.025000 1.000 1.000 

21000490 M Beef, liver 0.027000 1.000 1.000 

21000491 M Beef, liver-babyfood 0.027000 1.000 1.000 

23001690 M Goat, meat 0.017000 1.000 1.000 

23001700 M Goat, meat byproducts 0.027000 1.000 1.000 

23001710 M Goat, fat 0.390000 1.000 1.000 

23001720 M Goat, kidney 0.025000 1.000 1.000 

23001730 M Goat, liver 0.027000 1.000 1.000 

24001890 M Horse, meat 0.017000 1.000 1.000 

25002900 M Pork, meat 0.002600 1.000 1.000 

25002901 M Pork, meat-babyfood 0.002600 1.000 1.000 

25002910 M Pork, skin 0.058000 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 0.058000 1.000 1.000 

25002931 M Pork, fat-babyfood 0.058000 1.000 1.000 

25002940 M Pork, kidney 0.003700 1.000 1.000 

25002950 M Pork, liver 0.004100 1.000 1.000 

26003390 M Sheep, meat 0.017000 1.000 1.000 

26003391 M Sheep, meat-babyfood 0.017000 1.000 1.000 

26003400 M Sheep, meat byproducts 0.027000 1.000 1.000 

26003410 M Sheep, fat 0.390000 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.390000 1.000 1.000 

26003420 M Sheep, kidney 0.025000 1.000 1.000 

26003430 M Sheep, liver 0.027000 1.000 1.000 

27002220 D Milk, fat 0.850000 1.000 1.000 

27002221 D Milk, fat - baby food/infant for 0.850000 1.000 1.000 

27012230 D Milk, nonfat solids 0.034000 1.000 1.000 

27012231 D Milk, nonfat solids-baby food/in 0.034000 1.000 1.000 

40000930 P Chicken, meat 0.013000 1.000 1.000 

40000931 P Chicken, meat-babyfood 0.013000 1.000 1.000 

40000940 P Chicken, liver 0.033000 1.000 1.000 

40000950 P Chicken, meat byproducts 0.034000 1.000 1.000 

40000951 P Chicken, meat byproducts-babyfoo 0.034000 1.000 1.000 

40000960 P Chicken, fat 0.310000 1.000 1.000 

40000961 P Chicken, fat-babyfood 0.310000 1.000 1.000 

40000970 P Chicken, skin 0.310000 1.000 1.000 

40000971 P Chicken, skin-babyfood 0.310000 1.000 1.000 

50003820 P Turkey, meat 0.013000 1.000 1.000 

50003821 P Turkey, meat-babyfood 0.013000 1.000 1.000 

50003830 P Turkey, liver 0.033000 1.000 1.000 

50003831 P Turkey, liver-babyfood 0.033000 1.000 1.000 

50003840 P Turkey, meat byproducts 0.034000 1.000 1.000 

50003841 P Turkey, meat byproducts-babyfood 0.034000 1.000 1.000 

50003850 P Turkey, fat 0.310000 1.000 1.000 

50003851 P Turkey, fat-babyfood 0.310000 1.000 1.000 

50003860 P Turkey, skin 0.310000 1.000 1.000 

50003861 P Turkey, skin-babyfood 0.310000 1.000 1.000 

60003010 P Poultry, other, meat 0.013000 1.000 1.000 

60003020 P Poultry, other, liver 0.033000 1.000 1.000 

60003030 P Poultry, other, meat byproducts 0.034000 1.000 1.000 

60003040 P Poultry, other, fat 0.310000 1.000 1.000 

60003050 P Poultry, other, skin 0.310000 1.000 1.000 

70001450 P Egg, whole 0.062000 1.000 1.000 

70001451 P Egg, whole-babyfood 0.062000 1.000 1.000 

70001460 P Egg, white 0.062000 1.000 1.000 

70001461 P Egg, white (solids)-babyfood 0.062000 1.000 1.000 
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 18 of 26

70001470 P Egg, yolk 0.062000 1.000 1.000 

70001471 P Egg, yolk-babyfood 0.062000 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 0.025 

95001281 O Cottonseed, oil-babyfood 0.600000 1.000 0.025 

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 
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 19 of 26

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\Sorghum\DEEM\Sent to Reviewers\124002-chronic-2009-JLV__04-

FEB-10.R98

 Adjustment factor #2 used.

Analysis Date 02-05-2010/07:36:09 Residue file dated: 02-05-2010/07:35:49/8

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) 0.001206 11.0%

U.S. Population (spring season) 0.001184 10.8%

U.S. Population (summer season) 0.001335 12.1%

U.S. Population (autumn season) 0.001195 10.9%

U.S. Population (winter season) 0.001105 10.0%

Northeast region 0.001213 11.0%

Midwest region 0.001173 10.7%

Southern region 0.001200 10.9%

Western region 0.001245 11.3%

Hispanics 0.001179 10.7%

Non-hispanic whites 0.001087 9.9%

Non-hispanic blacks 0.001726 15.7%

Non-hisp/non-white/non-black 0.001753 15.9%

All infants (< 1 year) 0.001955 17.8%

Nursing infants 0.001113 10.1%

Non-nursing infants 0.002275 20.7%

Children 1-6 yrs 0.002960 26.9%

Children 7-12 yrs 0.001580 14.4%

Females 13-19 (not preg or nursing) 0.000901 8.2%

Females 20+ (not preg or nursing) 0.000933 8.5%

Females 13-50 yrs 0.000934 8.5%

Females 13+ (preg/not nursing) 0.000942 8.6%

Females 13+ (nursing) 0.001060 9.6%

Males 13-19 yrs 0.001136 10.3%

Males 20+ yrs 0.000936 8.5%

Seniors 55+ 0.001057 9.6%

Children 1-2 yrs 0.003537 32.2%

Children 3-5 yrs 0.002771 25.2%

Children 6-12 yrs 0.001700 15.5%

Youth 13-19 yrs 0.001021 9.3%

Adults 20-49 yrs 0.000884 8.0%

Adults 50+ yrs 0.001027 9.3%

Females 13-49 yrs 0.000874 7.9%

-------------------------------------------------------------------------------
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 20 of 26

Attachment 4: Usage Report Package in Support of Registration for the Insecticide 

Novaluron (124002), BEAN DP# 371221 (Memo, A. Grube, 17-NOV-2009)
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 21 of 26
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 22 of 26
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 23 of 26

Attachment 5: Percent Crop Treated for New Use (PCTn): Novaluron (124002) Use on 

Sorghum, DP# 371615 (Memo, C. Doucoure et al., 29-DEC-2009)
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 24 of 26
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 25 of 26
Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 26 of 26

The Confidential Attachment (page 5) of this document has not been included.