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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

DATE: April 20, 2015

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

Assessment for the Proposed Uses on Avocado; Carrot; Succulent Bean; Updated 

Crop Groupings for Vegetable, Fruiting, Crop Group 8-10; Fruit, Pome, Crop 

Group 11-10; Cherry Subgroup 12-12A; Peach Subgroup 12-12B; and Plum 

Subgroup 12-12C; and Revisions to the Label to Include Uses on GreenhouseGrown Cucumber. 

PC Code: 124002 DP Barcode: D426069

Decision No.: 487502 Registration No.: 53883-GGL

Petition No.: 4E8241 Regulatory Action: Section 3 Registration

Risk Assessment Type: Dietary Exposure Case No.: 7615

TXR No.: NA CAS No.: 116714-46-6

MRID No.: NA 40 CFR: §180.598

FROM: Richard Duncan, Associate Toxicologist

Department of Pesticide Regulation

California Environmental Protection Agency

and

Julie L. Van Alstine, MPH, Environmental Health Scientist

Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P)

THROUGH: Meheret Negussie, Chemist

William Cutchin, Chemist

Dietary Exposure Science Advisory Council (DESAC)

HED (7509P)

and

George F. Kramer, Ph.D., Branch Senior Chemist

RAB1/HED (7509P)

TO: Barbara Madden (RM 05)/Laura Nollen/Sidney Jackson

Registration Division (RD; 7505P) 
Novaluron Dietary Exposure & Risk Assessment D426069

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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 3.16, which uses food consumption data from the U.S. 

Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, 

What We Eat in America, (NHANES/WWEIA) from 2003 through 2008. The analysis was 

performed to support a Section 3 request for the proposed use of novaluron on avocado, carrot, 

and succulent beans, updated crop groupings for fruiting vegetable group 8-10, pome fruit group 

11-10, cherry subgroup 12-12A, peach subgroup 12-12B, and plum subgroup 12-12C, and the 

addition of greenhouse-grown cucumbers to the label. This memorandum was reviewed by two 

peer reviewers of the DESAC, per DESAC Standard Operating Procedure (SOP) 2012.1.

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

A partially refined chronic dietary (food and drinking water) exposure and risk assessment was 

conducted for all established uses and drinking water. Environmental Fate and Effects Division 

(EFED) provided estimated drinking water concentrations (EDWCs), which were incorporated 

directly into the analysis. The chronic analysis also incorporated average percent crop treated 

(PCT) data from the Biological and Economic Analysis Division (BEAD) for apples, blueberries, 

cabbage, cauliflower, cotton, dry beans, pears, peppers, potatoes, strawberries, and tomatoes, and 

average percent crop treated for new use (PCTn) data for the recently registered grain sorghum 

and sweet corn uses. The grain sorghum and sweet corn PCTn data provided by BEAD are the 

most recent PCT data available for these commodities. For the remaining commodities, 100% 

CT was assumed. Anticipated residues (ARs) for meat, milk, hog, and poultry commodities 

were calculated using average field trial residues, average PCTn data for grain sorghum and 

sweet corn, average PCT data for apple and cotton, and assumed 100% CT for sugarcane, 

aspirated grain fractions (AGF), and cowpea seed. The chronic analysis also incorporated 

tolerance-level residues for the recently registered soybean and peanut commodities, average 

field trial residues for the majority of commodities, average greenhouse trial residues for 

tomatoes and cucumbers, and, due to the registered use in food- and feed-handling 

establishments, half of the limit-of-quantitation (LOQ) residues for food commodities other than 

those covered by a higher tolerance as a result of use on growing crops. Empirical processing 

factors for apple juice (translated to pear and stone-fruit juice), cottonseed oil, dried plums, and 

tomato paste and purée, and DEEM (ver. 7.81) default processing factors for the remaining 

processed commodities were also incorporated. 

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 28% of the chronic population-adjusted dose (cPAD) 

for the general U.S. population and 73% of the cPAD for children 1-2 years old, the most highly

exposed population subgroup. 
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Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

A cancer dietary assessment was not conducted because novaluron is classified as “not likely to 

be carcinogenic to humans.”

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute 

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose 

(i.e., the dose that 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. References that 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.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2007-0780-0001; or see SOP 

99.6 (20-AUG-1999).

The most recent dietary risk assessment for novaluron was conducted by J. Van Alstine (5-FEB2014; D415835). 

II. Food Residue Information

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 degradate (3-

chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline) (Memo, G. Kramer et al., 03-FEB04; D297646). 

Established Tolerances: Tolerances for residues of novaluron are established under 40 CFR 

§180.598 in/on a wide variety of crops at levels ranging from 0.01 to 50 ppm. Tolerances for 

residues of novaluron are also established in/on the following livestock commodities: eggs, 

milk, milk fat, and the meat, fat, kidney, liver, and meat byproducts (except kidney and liver) of 

cattle, goat, horse, sheep, poultry, and hog. Additionally, novaluron is registered for use in foodand feed-handling establishments, and a tolerance of 0.01 ppm (the LOQ) has been established 

for residues in/on food and feed commodities other than those covered by a higher tolerance as a 

result of use on growing crops. 

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. Van Alstine, D418739): 
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Table 1. Tolerance Summary for Novaluron.

Commodity Proposed 

Tolerance (ppm)

HED-Recommended 

Tolerance (ppm)

Comments; 

Correct Commodity Definition

Avocado 0.60 0.60

Carrot 0.05 0.05

Bean 0.60 0.70

Harmonize with Codex MRL 

Bean, succulent1

Vegetable, fruiting, group 8-

102 1.0 1.0

Fruit, pome, group 11-1032.0 3.0 Harmonize with Codex MRL 

Cherry subgroup 12-12A48.0 8.0

Peach subgroup 12-12B51.9 1.9

Plum subgroup 12-12C51.9 1.9

Vegetable, cucurbit, group 9 -- 0.20 Harmonize with Codex MRL 

Plum, prune, dried -- 3.0 Harmonize with Codex MRL 

1

This tolerance will replace the existing tolerance of 0.60 ppm on bean, succulent, snap. The dry bean tolerance 

will not be impacted. 

2 This tolerance will replace the existing tolerances of 1.0 ppm on vegetable, fruiting, group 8, and also cocona, 

African eggplant, pea eggplant, scarlet eggplant, goji berry, garden huckleberry, martynia, naranjilla, okra, roselle, 

sunberry, bush tomato, currant tomato, and tree tomato. 

3 This tolerance will replace the existing tolerance of 2.0 ppm on fruit, pome, group 11. 

4 This tolerance will replace the existing tolerance of 8.0 ppm on cherry. 

5 These tolerances will replace the existing tolerance of 1.9 ppm on fruit, stone, group 12, except cherry.

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

average PCT data for apples, blueberries, cabbage, cauliflower, cotton, dry beans, pears, peppers, 

potatoes, strawberries, and tomatoes, average PCTn data for grain sorghum and sweet corn, and 

100% CT for the remaining commodities. HED assessed the grain sorghum use in 2010 and the 

sweet corn use in 2011, and the PCTn data provided by BEAD are the most recent PCT data 

available for these commodities. The chronic dietary analysis was refined through the use of 

average field trial residues for the majority of commodities, average greenhouse trial residues for 

tomatoes and cucumbers, and calculated ARs for meat, milk, hog, and poultry commodities. 

Tolerance-level residues were used for the recently registered peanut and soybean commodities. 

Additionally, due to the registered use in food- and feed-handling establishments, half-LOQ 

residues (0.01 ppm/2 = 0.005 ppm) were used for food commodities other than those covered by 

a higher tolerance as a result of use on growing crops. 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. 

Empirical processing factors for apple juice (translated to pear and stone-fruit juice), cottonseed 

oil, dried plums, and tomato paste and purée were utilized along with DEEM (ver. 7.81) default 

processing factors for the remaining processed commodities. 

The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, 

and 2010; however, the samples were not analyzed for novaluron. As a result, residue data from 

monitoring studies were not used for fish in this assessment. Based on the established tolerance 

for residues of novaluron in/on food commodities other than those covered by a higher tolerance 

due to use of novaluron in food- and feed-handling establishments, a half-LOQ residue of 0.005 

ppm was used for fish commodities. 
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Attachment 1 summarizes the residue, processing factor, and PCT and PCTn data that were 

incorporated into the current analysis. 

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

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

exists because there are livestock feedstuffs associated with the registered novaluron uses. 

Carrot culls, a carbohydrate concentrate, are the only livestock feed item associated with the 

current petition. Revisions to livestock dietary burdens and tolerances were not required for this 

petition since the incorporation of carrot culls into the dairy cattle livestock diet would not result 

in higher livestock dietary burdens. The most recent dietary exposure and risk assessment for 

novaluron includes livestock dietary burden calculations that incorporated average PCT (C. 

Doucoure, 05-DEC-2012) and PCTn (C. Doucoure, et al., 01-FEB-2013) data (Memo, J. Van 

Alstine, 15-MAY-2013; D401262). Please refer to Attachment 1 for the meat, milk, poultry, and 

hog ARs used in this assessment. 

III. Percent Crop Treated

BEAD recently provided a Screening-Level Usage Analysis (SLUA) memorandum entitled, 

“Usage Report Package in Support of Novaluron (124002), BEAN DP# 421177” (C. Doucoure, 

30-JUN-2014). The chronic dietary analysis incorporated average PCT data for apples (10%), 

blueberries (<1%), (cabbage (5%), cauliflower (<2.5%), cotton (<2.5%), dry beans (<1%), pears 

(15%), peppers (<2.5%), potatoes (<2.5%), strawberries (35%), and tomatoes (<2.5%) and 

average PCTn data for grain sorghum (2%) and sweet corn (36%). 100% CT was assumed for 

the remaining food commodities. Livestock dietary burdens of novaluron were calculated based 

on the registered uses, and incorporated average field trial residues, PCTn data for grain sorghum 

(2%) and sweet corn (36%), average PCT data for apple (10%) and cotton (<2.5%), and an 

assumption of 100% CT for sugarcane, AGF, and cowpea seed. 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 PCT data utilized in the chronic dietary assessment. Please refer 

to Attachments 4 and 5 for the PCT and PCTn data provided by BEAD. 

IV. Drinking Water Data

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 degradate (3-chloro-4-(1,1,2-

trifluoro-2-trifluoromethoxyethoxy)aniline) (Memo, G. Kramer et al., 03-FEB-04; D297646). 

The drinking water residues used in the dietary risk assessment were provided by EFED in the 

following memorandum: “Drinking Water Assessment in Support of the New Indoor and 

Outdoor non-food Use of Novaluron for Pest Control” (H. Zhong, 07-AUG-2013; D412441) and 

were incorporated directly into this dietary assessment into the food categories “water, direct, all 

sources” and “water, indirect, all sources.” EFED has indicated that revised drinking water 

estimates are not required based on the proposed uses (Memo, H. Zhong, 2-SEP-2014; 

D418740). 
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EFED completed the drinking water assessment in support of the proposed use of novaluron for 

indoor and outdoor use to control fleas, roaches, litter beetles, ants, and flying insect pests; and 

flies, beetles, and other insects in cattle, poultry, and horse operations. Two formulations were 

evaluated: 1) N+P Regulator, a liquid spray co-formulated with pyriproxyfen; and 2) Novaluron 

0.2G, a granular formulation. The single maximum application rates range from 0.023 to 0.872 

lb ai/A and the seasonal maximum application rates range from 0.14 to 14.82 lb ai/A. During the 

treatment for poultry/horse/cattle operations, the animal litter/manure is expected to be treated 

with novaluron and then used on field crops annually as fertilizer for nitrogen supplement. The 

novaluron annual application rates based on nutrient content conversion from the novaluron 

application to poultry litter and animal manure varied from 0.002 to 0.232 lb ai/A. Surface and 

ground water EDWCs were calculated using the Pesticide Root Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS), the Screening Concentration in Ground Water (SCIGROW), and Pesticide Root Zone Model for Ground Water (PRZM-GW) models. 

Surface Water

The EDWCs for the parent compound (novaluron) and two degradates of concern in surface 

water, the chlorophenyl urea (registrant synonym = 275-352I) and chloroaniline (275-309I) 

degradates, were modeled with PRZM/EXAMS, a Tier II model, assuming 100% of the standard 

reservoir watershed is treated with novaluron (percentage crop area or PCA = 1). The acute 

EDWC of parent novaluron in surface water is 4.81 μg/L (poultry operation via granular 

application) and exceeds the solubility of novaluron (3 μg/L), which is expected to be the upper 

bound environmental concentration. The estimated 1-in-10-year annual average (non-cancer 

chronic) and the 30-year annual average (cancer) are not expected to exceed 0.61 μg/L and 0.38 

μg/L. The surface water EDWCs for the chlorophenyl urea degradate are not expected to exceed 

8.77 μg/l, 6.01 μg/l, and 3.21 μg/l, and the surface water EDWCs for the chloroaniline degradate 

are not expected to exceed 12.59 μg/l, 10.05 μg/l, and 6.05 μg/l for acute, non-cancer chronic, 

and cancer assessments, respectively. 

Table 2 summarizes the surface water EDWCs that result in the highest total exposure estimate. 

Since the total novaluron and degradate surface water EDWCs are less than the total ground 

water EDWCs, ground water EDWCs were used in the assessment. 

Table 2. Summary of Novaluron EDWCs from Surface Water.1

Scenario

(PCA = 1)

Max Single Rate

/ Annual, (lb ai/A)

(Application Type)

1-in-10-Year Annual

Peak (μg/L)

1-in-10-Year Annual 

Mean (μg/L)

30-Year Annual

Mean (μg/L)

Novaluron

Poultry

PA Turf

0.872 / 14.82

(Granular) 3

2

0.6099 0.3801

Chlorophenyl Urea Degradate (275-352I)3

Poultry

PA Turf

0.1658 / 2.8194

Degradate in soil 8.7693 6.0087 3.2110

Chloroaniline Degradate (275-309I)4

Poultry

PA Turf

0.0467 / 0.7938

Degradate in soil 12.5930 10.0460 6.0513

Total of Novaluron and Chlorophenyl Urea and Chloroaniline Degradates 

Poultry

PA Turf -- 24.3623 16.6646 9.6424

1 This table summarizes the highest EDWCs for novaluron and its degradates resulting from the poultry PA turf 
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scenario. EFED provided several scenarios and corresponding EDWCs. The poultry PA turf scenario provides the 

highest total EDWC for surface water. 

2 The solubility of novaluron is 3 μg/L. The modeled EDWC for novaluron was 4.8070 μg/L; however, since the 

EDWC exceeds the solubility of novaluron, 3 μg/L was used.

3 Novaluron application rate is adjusted by 26.6% max degradate formation and 71.5% molecular weight (MW)

ratio.

4 Novaluron application rate is adjusted by 8.5% max degradate formation and 63% MW ratio. 

Ground Water

Novaluron appears to be immobile in soils according to the McCall classification (McCall et al., 

1980). It is unlikely that novaluron would reach potable ground water resources; however, both 

the chlorophenyl urea and chloroaniline degradates are mobile and persistent in soil, especially

under anaerobic conditions. The estimated concentrations of novaluron, chlorophenyl urea, and 

chloroaniline in shallow ground water sources were modeled using the SCI-GROW and PRZMGW models. 

The Tier I SCI-GROW screening model was used to estimate the upper bound ground water 

concentrations for novaluron, chlorophenyl urea, and chloroaniline. The model simulates ground 

water EDWCs likely to occur when the pesticide is used at the maximum allowable rate in areas 

where ground water is particularly vulnerable to contamination. EDWCs were simulated for the 

poultry operation application scenario using the SCI-GROW model and the results are 

summarized in Table 3. 

Table 3. EDWCs for Ground Water Sources Based on the Tier I SCI-GROW 2.3 Model and the Highest 

Maximum Application Rate for Poultry Operations.

Application Rate (lb/acre) No. of Applications Groundwater Concentration (ppb)

Novaluron 0.8720 17 8.72E-02

Chlorophenyl Urea

Degradate1

0.1658 17 7.00E-02

Chloroaniline

Degradate2

0.0467 17 3.55E-01

Total of Novaluron and Chlorophenyl Urea and Chloroaniline Degradates 5.12E-01

1 Application rate of chlorophenyl urea degradate is based on the maximum formation rate of 26.6 % from parent 

novaluron found in the aerobic soil metabolism study (MIRD 44961009) and 71.5% MW ratio.

2 Application rate of chloroaniline degradate is based on 8.5% max degradate and 63% formation from parent 

novaluron and molecular weight conversion (MWpar = 492.7; MWdeg = 310.6).

The ground water EDWCs were also simulated using the newer PRZM-GW model for six 

vulnerable sites in VA, FL, GA, NC, and WI using different applications scenarios. The 

proposed poultry operation uses combined with the WI corn scenario provided the highest total 

EDWC of all of the scenarios and is summarized in Table 4. Although the novaluron and 

chlorophenyl urea PRZM-GW EDWCs were considered invalid because of incomplete 

simulation, the WI scenario still results in the highest combined EDWC. 

Table 4. Summary of Novaluron EDWCs from Ground Water Using PRZM-GW Modeling for Poultry 

Operations.1

Crop/Scenario Highest Daily 

Value (μg/L)

Post Breakthrough 

Average (μg/L)

Average Simulation 

Breakthrough Time (Days)

Novaluron

Wisconsin Corn - WI Central Sands

Met File (14920.dvf) 2.58E-18 Incomplete Incomplete

Chlorophenyl Urea Degradate
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Table 4. Summary of Novaluron EDWCs from Ground Water Using PRZM-GW Modeling for Poultry 

Operations.1

Crop/Scenario Highest Daily 

Value (μg/L)

Post Breakthrough 

Average (μg/L)

Average Simulation 

Breakthrough Time (Days)

Wisconsin Corn - WI Central Sands

Met File (14920.dvf) 0.00815 Incomplete Incomplete

Chloroaniline Degradate

Wisconsin Corn - WI Central Sands

Met File (14920.dvf) 84.2 77.8 15,661

Total of Novaluron and Chlorophenyl Urea and Chloroaniline Degradates

Wisconsin Corn - WI Central Sands

Met File (14920.dvf) 84.21 77.8 15,661

1 EFED simulated ground water EDWCs using a newer PRZM-GW model for six vulnerable sites in VA, FL, GA, 

NC, and WI. This table summarizes the highest EDWCs for novaluron and its degradates that resulted from the 

proposed poultry operation uses combined with the Wisconsin Corn - WI Central Sands site. The WI site provides 

the highest total EDWC, and was used in the dietary exposure assessment. A value of 0 was used for novaluron and 

chlorophenyl urea in the total calculation since the post-breakthrough averages are incomplete for these EDWCs. 

EDWCs Used in the Assessment: The 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. Since the residues of concern in drinking water for risk assessment 

purposes are novaluron, the chlorophenyl urea degradate, and the chloroaniline degradate, these 

EDWCs were calculated using a molecular weight conversion and then combined for each 

modeled scenario. The degradates are assumed to have equal toxicity to the parent. The chronic 

dietary exposure and risk assessment incorporated the highest total EDWC of 77.8 μg/L (0.0778 

ppm) that was simulated using the PRZM-GW model with the proposed poultry operation use 

and WI corn scenario. 

V. DEEM-FCID Program and Consumption Information

A novaluron chronic dietary exposure assessment was conducted using DEEM-FCID, Version 

3.16, which incorporates consumption data from USDA’s NHANES/WWEIA from 2003 

through 2008. The data are based on the reported consumption of more than 20,000 individuals 

over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to 

EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat 

flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed 

jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are 

averaged for the entire U.S. population and within population subgroups. However, for acute 

exposure assessment, consumption data are retained as individual consumption events. Based on 

analysis of the 2003-2008 WWEIA 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 50-99 

years old.

For a 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 
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of the cPAD. This procedure is performed for each population subgroup.

VI. Toxicological Information

The RAB1 toxicologists have reevaluated the novaluron database and reaffirmed the previous 

conclusion of the Hazard Identification Assessment Review Committee (HIARC; 16-DEC-2003, 

TXR# 0052361) that the Food Quality Protection Act (FQPA) Safety Factor (SF) for increased 

susceptibility of infants and children can be reduced to 1X. The decision was based on a lack of 

increased susceptibility in the rat and/or rabbit developmental toxicity studies at levels up to the 

limit dose. In addition, 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 5 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 5. Summary of Toxicological Doses and Endpoints for Novaluron for Use in Dietary Exposure Risk 

Assessments.

Exposure/ 

Scenario POD Uncertainty/FQPA SF

RfD, PAD, LOC 

for Risk 

Assessment

Study and Toxicological Effects

Acute Dietary 

(General 

Population, 

including 

Infants and 

Children)

None None None

An endpoint of concern attributable to a 

single dose was not identified. An acute 

RfD was not established.

Chronic 

Dietary (All 

Populations)

NOAEL = 

1.1 

mg/kg/day

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 resulting in a 

compensatory 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 (c = chronic). RfD = reference dose. 

VII. Results/Discussion

As stated previously, for a chronic assessment, HED is concerned when dietary risk exceeds 

100% of the cPAD. The chronic analysis was performed using DEEM-FCID (ver. 3.16). The 

DEEM-FCID analysis estimates the dietary exposure of the U.S. population and various 

population subgroups. The results reported in Table 6 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 

50-99 years old, and females 13-49 years old. The resulting food and drinking water exposure 
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estimates were not of concern to HED (100% cPAD). The chronic dietary exposure estimates 

are 28% of the cPAD for the general U.S. population and 73% of the cPAD for children 1-2 

years old, the most highly exposed population subgroup.

Table 6. Summary of Chronic Dietary Exposure (Food and Drinking Water) and Risk for Novaluron1.

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

0.003071 28

N/A N/A

All Infants (<1 year old) 0.006289 57

Children 1-2 years old 0.008014 73

Children 3-5 years old 0.005711 52

Children 6-12 years old 0.003746 34

Youth 13-19 years old 0.002424 22

Adults 20-49 years old 0.002659 24

Adults 50-99 years old 0.002671 24

Females 13-49 years old 0.002640 24

1

Population with the greatest exposure is in bold. 

VIII. Characterization of Inputs/Outputs

The chronic dietary assessment was refined through the use of average field trial residues, 

average greenhouse trial residues for tomatoes and cucumbers, and ARs for meat, milk, hog, and 

poultry commodities. Empirical processing factors for apple juice (translated to pear and stonefruit juice), cottonseed oil, dried plums, 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 Attachment 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); and frozen immediately after harvest]. The current 

chronic dietary analysis also incorporated average PCT data for apples, blueberries, cabbage, 

cauliflower, cotton, dry beans, pears, peppers, potatoes, strawberries, and tomatoes, and average 

PCTn data for sorghum and sweet corn. 100% CT was assumed for the remaining commodities. 

ARs for meat, milk, hog, and poultry commodities were calculated using average field trial 

residues, average PCTn data for grain sorghum and sweet corn, average PCT data for apple and 

cotton, and 100% CT for sugarcane, AGF, and cowpea seed. 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. 3.16) for all 

established uses and drinking water. 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 28% of the cPAD for the general U.S. 

population and 73% of the cPAD for children 1-2 years old, the most highly exposed population 

subgroup. HED is confident that the assessment does not underestimate risk to the general U.S. 

population or any population subgroup. 

X. List of Attachments
Novaluron Dietary Exposure & Risk Assessment D426069

Page 11 of 30

Attachment 1: Processing Factors, ARs, and Average Field Trial Residues Used in Assessment

Attachment 2: DEEM-FCID Chronic Residue Input File

Attachment 3: DEEM-FCID Chronic Results File

Attachment 4: Usage Report Package in Support of Novaluron (124002), BEAN DP# 421177 

(Memo, C. Doucoure, 30-JUN-2014)

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

on Sorghum and Sweet Corn” (C. Doucoure, et al., 01-FEB-2013)

RDI: DE SAC Reviewers (26-FEB-2015); G. Kramer (23-FEB-2015)

DP No.: D426069

Petition No.: 4E8241

PC Code: 124002

J. L.Van Alstine:S-10951:PY-S:(703)603-8866:7509P:RAB1
Novaluron Dietary Exposure & Risk Assessment D426069

Page 12 of 30

Attachment 1: Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment

Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.

Crop (Listed in Crop Group Order) Commodity Processing 

Factor

Residue 

(ppm)1

Average 

PCT Comments

food commodities/feed commodities (other than 

those covered by a higher tolerance as a result of 

use on growing crops) from uses in food/feedhandling establishments

All 1 0.005 100%

1⁄2 LOQ residue [residues for all covered food matrices samples treated at a 3X 

application rate were <LOQ (<0.010 ppm) except for one sample of bread 

collected 4 hours post-application]; processing factors were not applied to these 

commodities; marked food-handling establishment (FHE)

carrot All 1 0.025 100% 1⁄2 LLMV [all measured residues were less than the lowest level of method 

validation (LLMV; 0.05 ppm)]

tuberous and corm vegetables (subgroup 1C)

All 1 0.025 <2.5% 1⁄2 LOQ residue (from US field trials); DEEM (ver. 7.78) default proc. factor of 

6.5 used for potato, dry and potato, flour; average PCT assumed for potato only; 

dry/flour (potato) 6.5 0.025 <2.5% other commodities use 100% CT (SLUA; C. Doucoure, 05-DEC-2012; D407102)

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

Brussels sprouts, cabbage, Chinese Napa cabbage, 

kohlrabi All 1 0.051 5%

average cabbage (without wrapper leaves) field trial residue; average PCT 

assumed for cabbage only; other commodities use 100% CT (SLUA; C. 

Doucoure, 30-JUN-2014; D421177); cabbage residues (without wrapper leaves) 

were translated to Brussels sprouts, Chinese Napa cabbage, and kohlrabi using 

HED SOP 2000.1

broccoli, Chinese broccoli, Chinese mustard 

cabbage, cauliflower All 1 0.106 <2.5%

average broccoli field trial residue; average PCT assumed for cauliflower only; 

other commodities use 100% CT (SLUA; C. Doucoure, 05-DEC-2012; 

D407102); broccoli residues were translated to Chinese broccoli, Chinese 

mustard cabbage, and cauliflower using HED SOP 2000.1

broccoli raab, Chinese bok choy cabbage, collards, 

kale, mustard greens, rape greens (Brassica, leafy 

greens, subgroup 5B), and turnip greens

All 1 5.33 100%

average mustard green field trial residue; mustard greens residues were translated 

to broccoli raab, Chinese bok choy cabbage, collards, kale, rape greens, and 

turnip greens using HED SOP 2000.1

soybean All 1 0.07 100% tolerance-level residue; refinements are not required at this time

lima bean, succulent All 1 0.0502 100% average lima bean field trial residue

broad bean, succulent; cowpea, succulent; snap 

bean, succulent; soybean, vegetable All 1 0.18 100% average succulent snap bean pods with seed field trial residue

dry beans All 1 0.065 <1% average dry bean seed field trial residue; average PCT for from SLUA memo 

(SLUA; C. Doucoure, 30-JUN-2014; D421177)

tomato, tomatillo, tree tomato, goji berry RAC 1 0.161 <2.5%

overall (small- & large-fruit varieties) average of the greenhouse trial residue; 

average PCT assumed for tomato only; other commodities use 100% CT (SLUA; 

C. Doucoure, 30-JUN-2014; D421177); tomato residues were translated to 

tomatillo and tree tomato using HED SOP 2000.1
Novaluron Dietary Exposure & Risk Assessment D426069

Page 13 of 30

Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.

Crop (Listed in Crop Group Order) Commodity Processing 

Factor

Residue 

(ppm)1

Average 

PCT Comments

dried 14.3 0.161 <2.5%

overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. 

fact; average PCT assumed for tomato only; other commodities use 100% CT 

(SLUA; C. Doucoure, 30-JUN-2014; D421177)

juice 1.5 0.161 <2.5%

overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. 

fact; average PCT assumed for tomato only; other commodities use 100% CT 

(SLUA; C. Doucoure, 30-JUN-2014; D421177)

purée 0.7 0.161 <2.5%

overall average of the greenhouse trial residue; empirical proc. fact.; average PCT 

assumed for tomato only; other commodities use 100% CT (SLUA; C. Doucoure, 

30-JUN-2014; D421177)

paste 1.1 0.161 <2.5%

overall average of the greenhouse trial residue; empirical proc. fact; average PCT 

assumed for tomato only; other commodities use 100% CT (SLUA; C. Doucoure, 

30-JUN-2014; D421177)

bell pepper, eggplant RAC 1 0.14 <2.5%

average bell pepper field trial residue; average PCT assumed for bell pepper only; 

use 100% CT for eggplant (SLUA; C. Doucoure, 30-JUN-2014; D421177); bell 

pepper residues were translated to eggplant using HED SOP 2000.1

non-bell pepper, okra RAC 1 0.16 <2.5%

average non-bell pepper field trial residue; average PCT assumed for non-bell 

pepper only; use 100% CT for okra (SLUA; C. Doucoure, 30-JUN-2014; 

D421177); non-bell pepper residues were translated to okra

cantaloupe, honeydew melon, watermelon All 1 0.055 100% average cantaloupe field trial residue; cantaloupe residues were translated to 

honeydew melon, and watermelon using HED SOP 2000.1

cucumber, Chinese waxgourd, balsam pear All 1 0.0542 100% average greenhouse cucumber field trial residue; cucumber residues were 

translated to Chinese waxgourd and balsam pear using HED SOP 2000.1

summer squash, chayote fruit Christophe, 

pumpkin, winter squash All 1 0.044 100%

average summer squash field trial residue; summer squash residues were 

translated to chayote fruit Christophe, pumpkin, and winter squash using HED 

SOP 2000.1

apple, crabapple

RAC, sauce 1 0.578 10%

weighted average field trial residue (of US and Canadian concentrate and dilute 

average residues); average PCT assumed for apple only (SLUA; C. Doucoure, 

05-DEC-2012; D407102); apple residues were translated to the remaining 

crabapple using HED SOP 2000.1

dried 8 0.578 10%

weighted average field trial residue (of US and Canada concentrate and dilute 

average residues); DEEM (ver. 7.78) default proc. fact.; average PCT assumed 

for apple only; other commodities use 100% CT (SLUA; C. Doucoure, 05-DEC2012; D407102)

juice 0.1 0.578 10%

weighted average field trial residue (of US and Canada concentrate and dilute 

average residues); empirical proc. fact.; average PCT assumed for apple only; 

other commodities use 100% CT (SLUA; C. Doucoure, 05-DEC-2012; D407102)
Novaluron Dietary Exposure & Risk Assessment D426069

Page 14 of 30

Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.

Crop (Listed in Crop Group Order) Commodity Processing 

Factor

Residue 

(ppm)1

Average 

PCT Comments

pear, loquat, quince

RAC 1 0.833 15%

weighted average field trial residue (of US and Canada concentrate and dilute 

average residues); average PCT assumed for pear only; other commodities use 

100% CT (SLUA; C. Doucoure, 05-DEC-2012; D407102); pear residues were 

translated to loquat and quince using HED SOP 2000.1

dried 6.25 0.833 15%

weighted average field trial residue (of US and Canada concentrate and dilute 

average residues); DEEM (ver. 7.78) default proc. fact.; average PCT assumed 

for pear only; other commodities use 100% CT (SLUA; C. Doucoure, 05-DEC2012; D407102)

juice 0.1 0.833 15%

weighted average field trial residue (of US and Canada concentrate and dilute 

average residues); empirical apple proc. fact.; average PCT assumed for pear 

only; other commodities use 100% CT (SLUA; C. Doucoure, 05-DEC-2012; 

D407102)

cherry

RAC 1 2.17 100% average field trial residue

juice 0.1 2.17 100% average field trial residue; empirical apple proc. fact.

peach, nectarine, and apricot

RAC 1 0.61 100% average peach field trial residue; peach residues were translated to nectarine and 

apricot crops using HED SOP 2000.1

dried (peach) 7

0.61 100% 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 dried (apricot) 6

juice 0.1 0.61 100% average peach field trial residue; empirical apple proc. fact.

plum

RAC 1 0.403 100% average plum field trial residue

dried 1 1.37 100% average plum field trial residue (0.403 ppm) x dried plum empirical processing 

factor (3.39)

juice 0.1 1.37 100% average plum field trial residue (0.403 ppm) x dried plum empirical processing 

factor (3.39); empirical apple proc. fact.

blueberry, currant, elderberry, gooseberry, and 

huckleberry (bushberry subgroup 13-07B) All 1 1.97 <1%

average blueberry field trial residue; 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); average PCT assumed for 

blueberry only (SLUA; C. Doucoure, 30-JUN-2014; D421177);

strawberry, cranberry [low growing berry 

subgroup 13-07G (except lowbush blueberry)]

RAC 1 0.14 35%

average strawberry field trial residue; 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); average PCT use for strawberry only; for cranberry use 100% CT

juice (strawberry) 1 0.14 35% average strawberry field trial residue; DEEM (ver. 7.78) default proc. fact. of 1.1 
Novaluron Dietary Exposure & Risk Assessment D426069

Page 15 of 30

Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.

Crop (Listed in Crop Group Order) Commodity Processing 

Factor

Residue 

(ppm)1

Average 

PCT Comments

juice (cranberry) 1.1 used for cranberry juice; average PCT use for strawberry only; other commodities 

use 100% CT (SLUA; C. Doucoure, 05-DEC-2012; D407102)

corn, sweet, kernel plus cob with husks removed All 1 0.025 36% 1⁄2 LLMV [all measured residues were less than the lowest level of method 

validation (LLMV; 0.05 ppm)] (PCTn memo: C. Doucoure, et al., 01-FEB-2013)

sorghum, grain, grain grain 1 1.23 2% average field trial residue; average PCT assumed for grain only (PCTn memo: C. 

Doucoure, et al., 01-FEB-2013)

cotton cottonseed oil 0.6 0.115 <2.5%

average field trial residue for cottonseed; empirical processing factor; average 

PCT for cotton from SLUA memo (SLUA; C. Doucoure, 05-DEC-2012; 

D407102)

meat of cattle, goat, horse, and sheep

meat 1 0.047 100% AR

dried beef 1.92 0.047 100% AR; DEEM (ver. 7.78) default proc. fact.

meat byproducts (except liver and kidney) of 

cattle, goat, horse, and sheep meat byproducts 1 1.04 100% AR (meat peritoneal fat)

fat (peritoneal) of cattle, goat, horse, and sheep fat 1 1.04 100% AR

kidney of cattle, goat, horse, and sheep kidney 1 0.057 100% AR

liver of cattle, goat, horse, and sheep liver 1 0.062 100% AR

pork meat meat 1 0.00050 100% AR

pork skin skin 1 0.011 100% AR (pork peritoneal fat)

pork meat byproducts (except liver and kidney) meat byproducts 1 0.011 100% AR (pork peritoneal fat)

pork fat (peritoneal) fat 1 0.011 100% AR

pork kidney kidney 1 0.00061 100% AR

pork liver liver 1 0.00067 100% AR

milk

milk, fat 1 1.96 100% AR, calculated assuming residues partition into fat [non-truncated whole milk 

secondary residue x 25 (maximum concentration factor for milk fat)]

milk, nonfat solids 1 0.078 100% AR for whole milk, used to account for low residues observed in skim milk

milk, water 1 0.005 100% FHE; All residues assumed to be associated with fat and solids

milk, sugar 1 0.005 100% FHE; All residues assumed to be associated with fat and solids

poultry meat meat 1 0.0025 100% AR
Novaluron Dietary Exposure & Risk Assessment D426069

Page 16 of 30

Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.

Crop (Listed in Crop Group Order) Commodity Processing 

Factor

Residue 

(ppm)1

Average 

PCT Comments

poultry liver liver 1 0.0063 100% AR

poultry meat byproducts (except kidney and liver) meat byproducts 1 0.059 100% AR (poultry abdominal fat)

poultry fat (abdominal) fat 1 0.059 100% AR

poultry skin skin 1 0.059 100% AR (poultry abdominal fat)

poultry kidney kidney 1 0.0065 100% AR

egg RAC 1 0.012 100% AR

water, direct, all sources and water, indirect, all 

sources

All 1 0.0778 100% Simulated using the PRZM-GW model with the proposed poultry operation use 

and WI corn scenario (H. Zhong, 07-AUG-2013; D412441). 

avocado All 1 0.192 100% average field trial residue

peanut

RAC 1 0.01 100% tolerance-level residue; refinements are not required at this time

butter 1.89 0.01 100% tolerance-level residue; refinements are not required at this time; DEEM default 

processing factor

oil 1 0.01 100% tolerance-level residue; refinements are not required at this time

sugarcane All 1 0.125 100% average field trial residue

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; Memo, J. Van Alstine 23-FEB-2010, D374419; Memo, J. Van Alstine 15-MAY-2013; D401263.
Novaluron Dietary Exposure & Risk Assessment D426069

Page 17 of 30

Attachment 2: DEEM-FCID Chronic Residue Input File

Filename: C:\Users\jlangsda\Documents\Chemicals\Novaluron\2014 Avocado, Carrot, Bean, 

Cucumber, and CG Tolerance Expansions\Dietary Memo\novaluron_chronic1_Feb 23 2015.R08

Chemical: Novaluron

RfD(Chronic): .011 mg/kg bw/day NOEL(Chronic): 1.1 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 02-23-2015/09:22:50 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0101050000 1AB Beet, garden, roots 0.005000 1.000 1.000 FHE

0101050001 1AB Beet, garden, roots-babyfood 0.005000 1.000 1.000 FHE

0101052000 1A Beet, sugar 0.005000 1.000 1.000 FHE

0101052001 1A Beet, sugar-babyfood 0.005000 1.000 1.000 FHE

0101053000 1A Beet, sugar, molasses 0.005000 1.000 1.000 FHE

0101053001 1A Beet, sugar, molasses-babyfood 0.005000 1.000 1.000 FHE

0101067000 1AB Burdock 0.005000 1.000 1.000 FHE

0101078000 1AB Carrot 0.025000 1.000 1.000 

0101078001 1AB Carrot-babyfood 0.025000 1.000 1.000 

0101079000 1AB Carrot, juice 0.025000 1.000 1.000 

0101084000 1AB Celeriac 0.005000 1.000 1.000 FHE

0101100000 1AB Chicory, roots 0.005000 1.000 1.000 FHE

0101168000 1AB Ginseng, dried 0.005000 1.000 1.000 FHE

0101190000 1AB Horseradish 0.005000 1.000 1.000 FHE

0101250000 1AB Parsley, turnip rooted 0.005000 1.000 1.000 FHE

0101251000 1AB Parsnip 0.005000 1.000 1.000 FHE

0101251001 1AB Parsnip-babyfood 0.005000 1.000 1.000 FHE

0101314000 1AB Radish, roots 0.005000 1.000 1.000 FHE

0101316000 1AB Radish, Oriental, roots 0.005000 1.000 1.000 FHE

0101327000 1AB Rutabaga 0.005000 1.000 1.000 FHE

0101331000 1AB Salsify, roots 0.005000 1.000 1.000 FHE

0101388000 1AB Turnip, roots 0.005000 1.000 1.000 FHE

0103015000 1CD Arrowroot, flour 0.025000 1.000 1.000 

0103015001 1CD Arrowroot, flour-babyfood 0.025000 1.000 1.000 

0103017000 1CD Artichoke, Jerusalem 0.025000 1.000 1.000 

0103082000 1CD Cassava 0.025000 1.000 1.000 

0103082001 1CD Cassava-babyfood 0.025000 1.000 1.000 

0103139000 1CD Dasheen, corm 0.025000 1.000 1.000 

0103166000 1CD Ginger 0.025000 1.000 1.000 

0103166001 1CD Ginger-babyfood 0.025000 1.000 1.000 

0103167000 1CD Ginger, dried 0.025000 1.000 1.000 

0103296000 1C Potato, chips 0.025000 1.000 0.025 

0103297000 1C Potato, dry (granules/ flakes) 0.025000 6.500 0.025 

0103297001 1C Potato, dry (granules/ flakes)-b 0.025000 6.500 0.025 

0103298000 1C Potato, flour 0.025000 6.500 0.025 

0103298001 1C Potato, flour-babyfood 0.025000 6.500 0.025 

0103299000 1C Potato, tuber, w/peel 0.025000 1.000 0.025 

0103299001 1C Potato, tuber, w/peel-babyfood 0.025000 1.000 0.025 

0103300000 1C Potato, tuber, w/o peel 0.025000 1.000 0.025 

0103300001 1C Potato, tuber, w/o peel-babyfood 0.025000 1.000 0.025 

0103366000 1CD Sweet potato 0.025000 1.000 1.000 

0103366001 1CD Sweet potato-babyfood 0.025000 1.000 1.000 

0103371000 1CD Tanier, corm 0.025000 1.000 1.000 

0103387000 1CD Turmeric 0.025000 1.000 1.000 

0103406000 1CD Yam, true 0.025000 1.000 1.000 

0103407000 1CD Yam bean 0.025000 1.000 1.000 

0200051000 2 Beet, garden, tops 0.005000 1.000 1.000 FHE

0200101000 2 Chicory, tops 0.005000 1.000 1.000 FHE

0200140000 2 Dasheen, leaves 0.005000 1.000 1.000 FHE

0200315000 2 Radish, tops 0.005000 1.000 1.000 FHE

0200317000 2 Radish, Oriental, tops 0.005000 1.000 1.000 FHE

0200332000 2 Salsify, tops 0.005000 1.000 1.000 FHE

0301165000 3A Garlic, bulb 0.005000 1.000 1.000 FHE

0301165001 3A Garlic, bulb-babyfood 0.005000 1.000 1.000 FHE

0301237000 3A Onion, bulb 0.005000 1.000 1.000 FHE

0301237001 3A Onion, bulb-babyfood 0.005000 1.000 1.000 FHE

0301238000 3A Onion, bulb, dried 0.005000 1.000 1.000 FHE

0301238001 3A Onion, bulb, dried-babyfood 0.005000 1.000 1.000 FHE
Novaluron Dietary Exposure & Risk Assessment D426069

Page 18 of 30

0301338000 3A Shallot, bulb 0.005000 1.000 1.000 FHE

0302103000 3B Chive, fresh leaves 0.005000 1.000 1.000 FHE

0302198000 3B Leek 0.005000 1.000 1.000 FHE

0302239000 3B Onion, green 0.005000 1.000 1.000 FHE

0302338500 3B Shallot, fresh leaves 0.005000 1.000 1.000 FHE

0401005000 4A Amaranth, leafy 0.005000 1.000 1.000 FHE

0401018000 4A Arugula 0.005000 1.000 1.000 FHE

0401104000 4A Chrysanthemum, garland 0.005000 1.000 1.000 FHE

0401133000 4A Cress, garden 0.005000 1.000 1.000 FHE

0401134000 4A Cress, upland 0.005000 1.000 1.000 FHE

0401138000 4A Dandelion, leaves 0.005000 1.000 1.000 FHE

0401150000 4A Endive 0.005000 1.000 1.000 FHE

0401204000 4A Lettuce, head 0.005000 1.000 1.000 FHE

0401205000 4A Lettuce, leaf 0.005000 1.000 1.000 FHE

0401248000 4A Parsley, leaves 0.005000 1.000 1.000 FHE

0401313000 4A Radicchio 0.005000 1.000 1.000 FHE

0401355000 4A Spinach 0.005000 1.000 1.000 FHE

0401355001 4A Spinach-babyfood 0.005000 1.000 1.000 FHE

0402076000 4B Cardoon 0.005000 1.000 1.000 FHE

0402085000 4B Celery 0.005000 1.000 1.000 FHE

0402085001 4B Celery-babyfood 0.005000 1.000 1.000 FHE

0402086000 4B Celery, juice 0.005000 1.000 1.000 FHE

0402087000 4B Celtuce 0.005000 1.000 1.000 FHE

0402152000 4B Fennel, Florence 0.005000 1.000 1.000 FHE

0402322000 4B Rhubarb 0.005000 1.000 1.000 FHE

0402367000 4B Swiss chard 4.200000 1.000 1.000 

0501061000 5A Broccoli 0.106000 1.000 1.000 

0501061001 5A Broccoli-babyfood 0.106000 1.000 1.000 

0501062000 5A Broccoli, Chinese 0.106000 1.000 1.000 

0501064000 5A Brussels sprouts 0.051000 1.000 1.000 

0501069000 5A Cabbage 0.051000 1.000 0.050 

0501071000 5A Cabbage, Chinese, napa 0.051000 1.000 1.000 

0501072000 5A Cabbage, Chinese, mustard 0.106000 1.000 1.000 

0501083000 5A Cauliflower 0.106000 1.000 0.025 

0501196000 5A Kohlrabi 0.051000 1.000 1.000 

0502063000 5B Broccoli raab 5.330000 1.000 1.000 

0502070000 5B Cabbage, Chinese, bok choy 5.330000 1.000 1.000 

0502117000 5B Collards 5.330000 1.000 1.000 

0502194000 5B Kale 5.330000 1.000 1.000 

0502229000 5B Mustard greens 5.330000 1.000 1.000 

0502318000 5B Rape greens 5.330000 1.000 1.000 

0502389000 5B Turnip, greens 5.330000 1.000 1.000 

0600347000 6 Soybean, seed 0.070000 1.000 1.000 

0600349000 6 Soybean, soy milk 0.070000 1.000 1.000 

0600349001 6 Soybean, soy milk-babyfood or in 0.070000 1.000 1.000 

0600350000 6 Soybean, oil 0.070000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 0.070000 1.000 1.000 

0601043000 6A Bean, snap, succulent 0.180000 1.000 1.000 

0601043001 6A Bean, snap, succulent-babyfood 0.180000 1.000 1.000 

0601257000 6A Pea, edible podded, succulent 0.005000 1.000 1.000 FHE

0601349500 6AB Soybean, vegetable 0.180000 1.000 1.000 

0602031000 6B Bean, broad, succulent 0.180000 1.000 1.000 

0602033000 6B Bean, cowpea, succulent 0.180000 1.000 1.000 

0602037000 6B Bean, lima, succulent 0.050200 1.000 1.000 

0602255000 6B Pea, succulent 0.005000 1.000 1.000 FHE

0602255001 6B Pea, succulent-babyfood 0.005000 1.000 1.000 FHE

0602259000 6B Pea, pigeon, succulent 0.005000 1.000 1.000 FHE

0603030000 6C Bean, black, seed 0.065000 1.000 0.010 

0603032000 6C Bean, broad, seed 0.065000 1.000 0.010 

0603034000 6C Bean, cowpea, seed 0.065000 1.000 0.010 

0603035000 6C Bean, great northern, seed 0.065000 1.000 0.010 

0603036000 6C Bean, kidney, seed 0.065000 1.000 0.010 

0603038000 6C Bean, lima, seed 0.065000 1.000 0.010 

0603039000 6C Bean, mung, seed 0.065000 1.000 0.010 

0603040000 6C Bean, navy, seed 0.065000 1.000 0.010 

0603041000 6C Bean, pink, seed 0.065000 1.000 0.010 

0603042000 6C Bean, pinto, seed 0.065000 1.000 0.010 

0603098000 6C Chickpea, seed 0.065000 1.000 0.010 

0603098001 6C Chickpea, seed-babyfood 0.065000 1.000 0.010 

0603099000 6C Chickpea, flour 0.065000 1.000 0.010 
Novaluron Dietary Exposure & Risk Assessment D426069

Page 19 of 30

0603182000 6C Guar, seed 0.065000 1.000 0.010 

0603182001 6C Guar, seed-babyfood 0.065000 1.000 0.010 

0603203000 6C Lentil, seed 0.005000 1.000 1.000 FHE

0603256000 6C Pea, dry 0.005000 1.000 1.000 FHE

0603256001 6C Pea, dry-babyfood 0.005000 1.000 1.000 FHE

0603258000 6C Pea, pigeon, seed 0.005000 1.000 1.000 FHE

0603348000 6C Soybean, flour 0.070000 1.000 1.000 

0603348001 6C Soybean, flour-babyfood 0.070000 1.000 1.000 

0801374000 8A Tomatillo 0.161000 1.000 1.000 

0801375000 8A Tomato 0.161000 1.000 0.025 

0801375001 8A Tomato-babyfood 0.161000 1.000 0.025 

0801376000 8A Tomato, paste 0.161000 1.100 0.025 

0801376001 8A Tomato, paste-babyfood 0.161000 1.100 0.025 

0801377000 8A Tomato, puree 0.161000 0.700 0.025 

0801377001 8A Tomato, puree-babyfood 0.161000 0.700 0.025 

0801378000 8A Tomato, dried 0.161000 14.300 0.025 

0801378001 8A Tomato, dried-babyfood 0.161000 14.300 0.025 

0801379000 8A Tomato, juice 0.161000 1.500 0.025 

0801380000 8A Tomato, Tree 0.161000 1.000 1.000 

0802148000 8BC Eggplant 0.140000 1.000 1.000 

0802234000 8BC Okra 0.160000 1.000 1.000 

0802270000 8B Pepper, bell 0.140000 1.000 0.025 

0802270001 8B Pepper, bell-babyfood 0.140000 1.000 0.025 

0802271000 8B Pepper, bell, dried 0.140000 1.000 0.025 

0802271001 8B Pepper, bell, dried-babyfood 0.140000 1.000 0.025 

0802272000 8BC Pepper, nonbell 0.160000 1.000 0.025 

0802272001 8BC Pepper, nonbell-babyfood 0.160000 1.000 0.025 

0802273000 8BC Pepper, nonbell, dried 0.160000 1.000 0.025 

0901075000 9A Cantaloupe 0.055000 1.000 1.000 

0901187000 9A Honeydew melon 0.055000 1.000 1.000 

0901399000 9A Watermelon 0.055000 1.000 1.000 

0901400000 9A Watermelon, juice 0.055000 1.000 1.000 

0902021000 9B Balsam pear 0.054200 1.000 1.000 

0902088000 9B Chayote, fruit 0.044000 1.000 1.000 

0902102000 9B Chinese waxgourd 0.054200 1.000 1.000 

0902135000 9B Cucumber 0.054200 1.000 1.000 

0902308000 9B Pumpkin 0.044000 1.000 1.000 

0902309000 9B Pumpkin, seed 0.044000 1.000 1.000 

0902356000 9B Squash, summer 0.044000 1.000 1.000 

0902356001 9B Squash, summer-babyfood 0.044000 1.000 1.000 

0902357000 9B Squash, winter 0.044000 1.000 1.000 

0902357001 9B Squash, winter-babyfood 0.044000 1.000 1.000 

1001106000 10A Citron 0.005000 1.000 1.000 FHE

1001107000 10A Citrus hybrids 0.005000 1.000 1.000 FHE

1001108000 10A Citrus, oil 0.005000 1.000 1.000 FHE

1001240000 10A Orange 0.005000 1.000 1.000 FHE

1001241000 10A Orange, juice 0.005000 1.000 1.000 FHE

1001241001 10A Orange, juice-babyfood 0.005000 1.000 1.000 FHE

1001242000 10A Orange, peel 0.005000 1.000 1.000 FHE

1001369000 10A Tangerine 0.005000 1.000 1.000 FHE

1001370000 10A Tangerine, juice 0.005000 1.000 1.000 FHE

1002197000 10B Kumquat 0.005000 1.000 1.000 FHE

1002199000 10B Lemon 0.005000 1.000 1.000 FHE

1002200000 10B Lemon, juice 0.005000 1.000 1.000 FHE

1002200001 10B Lemon, juice-babyfood 0.005000 1.000 1.000 FHE

1002201000 10B Lemon, peel 0.005000 1.000 1.000 FHE

1002206000 10B Lime 0.005000 1.000 1.000 FHE

1002207000 10B Lime, juice 0.005000 1.000 1.000 FHE

1002207001 10B Lime, juice-babyfood 0.005000 1.000 1.000 FHE

1003180000 10C Grapefruit 0.005000 1.000 1.000 FHE

1003181000 10C Grapefruit, juice 0.005000 1.000 1.000 FHE

1003307000 10C Pummelo 0.005000 1.000 1.000 FHE

1100007000 11 Apple, fruit with peel 0.578000 1.000 0.100 

1100008000 11 Apple, peeled fruit 0.578000 1.000 0.100 

1100008001 11 Apple, peeled fruit-babyfood 0.578000 1.000 0.100 

1100009000 11 Apple, dried 0.578000 8.000 0.100 

1100009001 11 Apple, dried-babyfood 0.578000 8.000 0.100 

1100010000 11 Apple, juice 0.578000 0.100 0.100 

1100010001 11 Apple, juice-babyfood 0.578000 0.100 0.100 

1100011000 11 Apple, sauce 0.578000 1.000 0.100 
Novaluron Dietary Exposure & Risk Assessment D426069

Page 20 of 30

1100011001 11 Apple, sauce-babyfood 0.578000 1.000 0.100 

1100129000 11 Crabapple 0.578000 1.000 1.000 

1100173500 11 Goji berry 0.161000 1.000 1.000 

1100210000 11 Loquat 0.833000 1.000 1.000 

1100266000 11 Pear 0.833000 1.000 0.150 

1100266001 11 Pear-babyfood 0.833000 1.000 0.150 

1100267000 11 Pear, dried 0.833000 6.250 0.150 

1100268000 11 Pear, juice 0.833000 0.100 0.150 

1100268001 11 Pear, juice-babyfood 0.833000 0.100 0.150 

1100310000 11 Quince 0.833000 1.000 1.000 

1201090000 12A Cherry 2.170000 1.000 1.000 

1201090001 12A Cherry-babyfood 2.170000 1.000 1.000 

1201091000 12A Cherry, juice 2.170000 0.100 1.000 

1201091001 12A Cherry, juice-babyfood 2.170000 0.100 1.000 

1202012000 12B Apricot 0.610000 1.000 1.000 

1202012001 12B Apricot-babyfood 0.610000 1.000 1.000 

1202013000 12B Apricot, dried 0.610000 6.000 1.000 

1202014000 12B Apricot, juice 0.610000 0.100 1.000 

1202014001 12B Apricot, juice-babyfood 0.610000 0.100 1.000 

1202230000 12B Nectarine 0.610000 1.000 1.000 

1202260000 12B Peach 0.610000 1.000 1.000 

1202260001 12B Peach-babyfood 0.610000 1.000 1.000 

1202261000 12B Peach, dried 0.610000 7.000 1.000 

1202261001 12B Peach, dried-babyfood 0.610000 7.000 1.000 

1202262000 12B Peach, juice 0.610000 0.100 1.000 

1202262001 12B Peach, juice-babyfood 0.610000 0.100 1.000 

1203285000 12C Plum 0.403000 1.000 1.000 

1203285001 12C Plum-babyfood 0.403000 1.000 1.000 

1203286000 12C Plum, prune, fresh 0.403000 1.000 1.000 

1203286001 12C Plum, prune, fresh-babyfood 0.403000 1.000 1.000 

1203287000 12C Plum, prune, dried 1.370000 1.000 1.000 

1203287001 12C Plum, prune, dried-babyfood 1.370000 1.000 1.000 

1203288000 12C Plum, prune, juice 1.370000 0.100 1.000 

1203288001 12C Plum, prune, juice-babyfood 1.370000 0.100 1.000 

1301055000 13A Blackberry 0.005000 1.000 1.000 FHE

1301056000 13A Blackberry, juice 0.005000 1.000 1.000 FHE

1301056001 13A Blackberry, juice-babyfood 0.005000 1.000 1.000 FHE

1301058000 13A Boysenberry 0.005000 1.000 1.000 FHE

1301208000 13A Loganberry 0.005000 1.000 1.000 FHE

1301320000 13A Raspberry 0.005000 1.000 1.000 FHE

1301320001 13A Raspberry-babyfood 0.005000 1.000 1.000 FHE

1301321000 13A Raspberry, juice 0.005000 1.000 1.000 FHE

1301321001 13A Raspberry, juice-babyfood 0.005000 1.000 1.000 FHE

1302057000 13B Blueberry 1.970000 1.000 0.010 

1302057001 13B Blueberry-babyfood 1.970000 1.000 0.010 

1302136000 13B Currant 1.970000 1.000 1.000 

1302137000 13B Currant, dried 1.970000 1.000 1.000 

1302149000 13B Elderberry 1.970000 1.000 1.000 

1302174000 13B Gooseberry 1.970000 1.000 1.000 

1302191000 13B Huckleberry 1.970000 1.000 1.000 

1303227000 13C Mulberry 0.005000 1.000 1.000 FHE

1304175000 13D Grape 0.005000 1.000 1.000 FHE

1304176000 13D Grape, juice 0.005000 1.000 1.000 FHE

1304176001 13D Grape, juice-babyfood 0.005000 1.000 1.000 FHE

1304179000 13D Grape, wine and sherry 0.005000 1.000 1.000 FHE

1304195000 13D Kiwifruit, fuzzy 0.005000 1.000 1.000 FHE

1307130000 13G Cranberry 0.140000 1.000 1.000 

1307130001 13G Cranberry-babyfood 0.140000 1.000 1.000 

1307131000 13G Cranberry, dried 0.140000 1.000 1.000 

1307132000 13G Cranberry, juice 0.140000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 0.140000 1.100 1.000 

1307359000 13G Strawberry 0.140000 1.000 0.350 

1307359001 13G Strawberry-babyfood 0.140000 1.000 0.350 

1307360000 13G Strawberry, juice 0.140000 1.000 0.350 

1307360001 13G Strawberry, juice-babyfood 0.140000 1.000 0.350 

1400003000 14 Almond 0.005000 1.000 1.000 FHE

1400003001 14 Almond-babyfood 0.005000 1.000 1.000 FHE

1400004000 14 Almond, oil 0.005000 1.000 1.000 FHE

1400004001 14 Almond, oil-babyfood 0.005000 1.000 1.000 FHE

1400059000 14 Brazil nut 0.005000 1.000 1.000 FHE
Novaluron Dietary Exposure & Risk Assessment D426069

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1400068000 14 Butternut 0.005000 1.000 1.000 FHE

1400081000 14 Cashew 0.005000 1.000 1.000 FHE

1400092000 14 Chestnut 0.005000 1.000 1.000 FHE

1400155000 14 Hazelnut 0.005000 1.000 1.000 FHE

1400156000 14 Hazelnut, oil 0.005000 1.000 1.000 FHE

1400185000 14 Hickory nut 0.005000 1.000 1.000 FHE

1400213000 14 Macadamia nut 0.005000 1.000 1.000 FHE

1400269000 14 Pecan 0.005000 1.000 1.000 FHE

1400278000 14 Pine nut 0.005000 1.000 1.000 FHE

1400282000 14 Pistachio 0.005000 1.000 1.000 FHE

1400391000 14 Walnut 0.005000 1.000 1.000 FHE

1500025000 15 Barley, pearled barley 0.005000 1.000 1.000 FHE

1500025001 15 Barley, pearled barley-babyfood 0.005000 1.000 1.000 FHE

1500026000 15 Barley, flour 0.005000 1.000 1.000 FHE

1500026001 15 Barley, flour-babyfood 0.005000 1.000 1.000 FHE

1500027000 15 Barley, bran 0.005000 1.000 1.000 FHE

1500065000 15 Buckwheat 0.005000 1.000 1.000 FHE

1500066000 15 Buckwheat, flour 0.005000 1.000 1.000 FHE

1500120000 15 Corn, field, flour 0.005000 1.000 1.000 FHE

1500120001 15 Corn, field, flour-babyfood 0.005000 1.000 1.000 FHE

1500121000 15 Corn, field, meal 0.005000 1.000 1.000 FHE

1500121001 15 Corn, field, meal-babyfood 0.005000 1.000 1.000 FHE

1500122000 15 Corn, field, bran 0.005000 1.000 1.000 FHE

1500123000 15 Corn, field, starch 0.005000 1.000 1.000 FHE

1500123001 15 Corn, field, starch-babyfood 0.005000 1.000 1.000 FHE

1500124000 15 Corn, field, syrup 0.005000 1.000 1.000 FHE

1500124001 15 Corn, field, syrup-babyfood 0.005000 1.000 1.000 FHE

1500125000 15 Corn, field, oil 0.005000 1.000 1.000 FHE

1500125001 15 Corn, field, oil-babyfood 0.005000 1.000 1.000 FHE

1500126000 15 Corn, pop 0.005000 1.000 1.000 FHE

1500127000 15 Corn, sweet 0.025000 1.000 0.360 

1500127001 15 Corn, sweet-babyfood 0.025000 1.000 0.360 

1500226000 15 Millet, grain 0.005000 1.000 1.000 FHE

1500231000 15 Oat, bran 0.005000 1.000 1.000 FHE

1500232000 15 Oat, flour 0.005000 1.000 1.000 FHE

1500232001 15 Oat, flour-babyfood 0.005000 1.000 1.000 FHE

1500233000 15 Oat, groats/rolled oats 0.005000 1.000 1.000 FHE

1500233001 15 Oat, groats/rolled oats-babyfood 0.005000 1.000 1.000 FHE

1500323000 15 Rice, white 0.005000 1.000 1.000 FHE

1500323001 15 Rice, white-babyfood 0.005000 1.000 1.000 FHE

1500324000 15 Rice, brown 0.005000 1.000 1.000 FHE

1500324001 15 Rice, brown-babyfood 0.005000 1.000 1.000 FHE

1500325000 15 Rice, flour 0.005000 1.000 1.000 FHE

1500325001 15 Rice, flour-babyfood 0.005000 1.000 1.000 FHE

1500326000 15 Rice, bran 0.005000 1.000 1.000 FHE

1500326001 15 Rice, bran-babyfood 0.005000 1.000 1.000 FHE

1500328000 15 Rye, grain 0.005000 1.000 1.000 FHE

1500329000 15 Rye, flour 0.005000 1.000 1.000 FHE

1500344000 15 Sorghum, grain 1.230000 1.000 0.020 

1500345000 15 Sorghum, syrup 0.005000 1.000 1.000 FHE

1500381000 15 Triticale, flour 0.005000 1.000 1.000 FHE

1500381001 15 Triticale, flour-babyfood 0.005000 1.000 1.000 FHE

1500401000 15 Wheat, grain 0.005000 1.000 1.000 FHE

1500401001 15 Wheat, grain-babyfood 0.005000 1.000 1.000 FHE

1500402000 15 Wheat, flour 0.005000 1.000 1.000 FHE

1500402001 15 Wheat, flour-babyfood 0.005000 1.000 1.000 FHE

1500403000 15 Wheat, germ 0.005000 1.000 1.000 FHE

1500404000 15 Wheat, bran 0.005000 1.000 1.000 FHE

1500405000 15 Wild rice 0.005000 1.000 1.000 FHE

1800002000 18 Alfalfa, seed 0.005000 1.000 1.000 FHE

1901028000 19A Basil, fresh leaves 0.005000 1.000 1.000 FHE

1901028001 19A Basil, fresh leaves-babyfood 0.005000 1.000 1.000 FHE

1901029000 19A Basil, dried leaves 0.005000 1.000 1.000 FHE

1901029001 19A Basil, dried leaves-babyfood 0.005000 1.000 1.000 FHE

1901102500 19A Chive, dried leaves 0.005000 1.000 1.000 FHE

1901118000 19A Cilantro, leaves 0.005000 1.000 1.000 FHE

1901118001 19A Cilantro, leaves-babyfood 0.005000 1.000 1.000 FHE

1901144000 19A Dillweed 0.005000 1.000 1.000 FHE

1901184000 19A Herbs, other 0.005000 1.000 1.000 FHE

1901184001 19A Herbs, other-babyfood 0.005000 1.000 1.000 FHE
Novaluron Dietary Exposure & Risk Assessment D426069

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1901202000 19A Lemongrass 0.005000 1.000 1.000 FHE

1901220000 19A Marjoram 0.005000 1.000 1.000 FHE

1901220001 19A Marjoram-babyfood 0.005000 1.000 1.000 FHE

1901249000 19A Parsley, dried leaves 0.005000 1.000 1.000 FHE

1901249001 19A Parsley, dried leaves-babyfood 0.005000 1.000 1.000 FHE

1901334000 19A Savory 0.005000 1.000 1.000 FHE

1902105000 19B Cinnamon 0.005000 1.000 1.000 FHE

1902105001 19B Cinnamon-babyfood 0.005000 1.000 1.000 FHE

1902119000 19B Coriander, seed 0.005000 1.000 1.000 FHE

1902119001 19B Coriander, seed-babyfood 0.005000 1.000 1.000 FHE

1902143000 19B Dill, seed 0.005000 1.000 1.000 FHE

1902274000 19B Pepper, black and white 0.005000 1.000 1.000 FHE

1902274001 19B Pepper, black and white-babyfood 0.005000 1.000 1.000 FHE

1902354000 19B Spices, other 0.005000 1.000 1.000 FHE

1902354001 19B Spices, other-babyfood 0.005000 1.000 1.000 FHE

2001163000 20A Flax seed, oil 0.005000 1.000 1.000 FHE

2001319000 20A Rapeseed, oil 0.005000 1.000 1.000 FHE

2001319001 20A Rapeseed, oil-babyfood 0.005000 1.000 1.000 FHE

2001336000 20A Sesame, seed 0.005000 1.000 1.000 FHE

2001336001 20A Sesame, seed-babyfood 0.005000 1.000 1.000 FHE

2001337000 20A Sesame, oil 0.005000 1.000 1.000 FHE

2001337001 20A Sesame, oil-babyfood 0.005000 1.000 1.000 FHE

2002330000 20B Safflower, oil 0.005000 1.000 1.000 FHE

2002330001 20B Safflower, oil-babyfood 0.005000 1.000 1.000 FHE

2002364000 20B Sunflower, seed 0.005000 1.000 1.000 FHE

2002365000 20B Sunflower, oil 0.005000 1.000 1.000 FHE

2002365001 20B Sunflower, oil-babyfood 0.005000 1.000 1.000 FHE

2003114001 20C Coconut, oil-babyfood 0.005000 1.000 1.000 FHE

2003128000 20C Cottonseed, oil 0.115000 0.600 0.025 

2003128001 20C Cottonseed, oil-babyfood 0.115000 0.600 0.025 

2100228000 21 Mushroom 0.005000 1.000 1.000 FHE

3100044000 31 Beef, meat 0.047000 1.000 1.000 

3100044001 31 Beef, meat-babyfood 0.047000 1.000 1.000 

3100045000 31 Beef, meat, dried 0.047000 1.920 1.000 

3100046000 31 Beef, meat byproducts 1.040000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 1.040000 1.000 1.000 

3100047000 31 Beef, fat 1.040000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 1.040000 1.000 1.000 

3100048000 31 Beef, kidney 0.057000 1.000 1.000 

3100049000 31 Beef, liver 0.062000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 0.062000 1.000 1.000 

3200169000 32 Goat, meat 0.047000 1.000 1.000 

3200170000 32 Goat, meat byproducts 1.040000 1.000 1.000 

3200171000 32 Goat, fat 1.040000 1.000 1.000 

3200172000 32 Goat, kidney 0.057000 1.000 1.000 

3200173000 32 Goat, liver 0.062000 1.000 1.000 

3300189000 33 Horse, meat 0.047000 1.000 1.000 

3400290000 34 Pork, meat 0.000500 1.000 1.000 

3400290001 34 Pork, meat-babyfood 0.000500 1.000 1.000 

3400291000 34 Pork, skin 0.011000 1.000 1.000 

3400292000 34 Pork, meat byproducts 0.011000 1.000 1.000 

3400292001 34 Pork, meat byproducts-babyfood 0.011000 1.000 1.000 

3400293000 34 Pork, fat 0.011000 1.000 1.000 

3400293001 34 Pork, fat-babyfood 0.011000 1.000 1.000 

3400294000 34 Pork, kidney 0.000610 1.000 1.000 

3400295000 34 Pork, liver 0.000670 1.000 1.000 

3500339000 35 Sheep, meat 0.047000 1.000 1.000 

3500339001 35 Sheep, meat-babyfood 0.047000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 1.040000 1.000 1.000 

3500341000 35 Sheep, fat 1.040000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 1.040000 1.000 1.000 

3500342000 35 Sheep, kidney 0.057000 1.000 1.000 

3500343000 35 Sheep, liver 0.062000 1.000 1.000 

3600222000 36 Milk, fat 1.960000 1.000 1.000 

3600222001 36 Milk, fat-baby food/infant formu 1.960000 1.000 1.000 

3600223000 36 Milk, nonfat solids 0.078000 1.000 1.000 

3600223001 36 Milk, nonfat solids-baby food/in 0.078000 1.000 1.000 

3600224000 36 Milk, water 0.005000 1.000 1.000 FHE; a

 Full comment: FHE; all res in milk assumed assoc w/fats & solids

3600224001 36 Milk, water-babyfood/infant form 0.005000 1.000 1.000 FHE; a
Novaluron Dietary Exposure & Risk Assessment D426069

Page 23 of 30

 Full comment: FHE; all res in milk assumed assoc w/fats & solids

3600225001 36 Milk, sugar (lactose)-baby food/ 0.005000 1.000 1.000 FHE; a

 Full comment: FHE; all res in milk assumed assoc w/fats & solids

3800221000 38 Meat, game 0.047000 1.000 1.000 

3900312000 39 Rabbit, meat 0.047000 1.000 1.000 

4000093000 40 Chicken, meat 0.002500 1.000 1.000 

4000093001 40 Chicken, meat-babyfood 0.002500 1.000 1.000 

4000094000 40 Chicken, liver 0.006300 1.000 1.000 

4000095000 40 Chicken, meat byproducts 0.059000 1.000 1.000 

4000095001 40 Chicken, meat byproducts-babyfoo 0.059000 1.000 1.000 

4000096000 40 Chicken, fat 0.059000 1.000 1.000 

4000096001 40 Chicken, fat-babyfood 0.059000 1.000 1.000 

4000097000 40 Chicken, skin 0.059000 1.000 1.000 

4000097001 40 Chicken, skin-babyfood 0.059000 1.000 1.000 

5000382000 50 Turkey, meat 0.002500 1.000 1.000 

5000382001 50 Turkey, meat-babyfood 0.002500 1.000 1.000 

5000383000 50 Turkey, liver 0.006300 1.000 1.000 

5000383001 50 Turkey, liver-babyfood 0.006300 1.000 1.000 

5000384000 50 Turkey, meat byproducts 0.059000 1.000 1.000 

5000384001 50 Turkey, meat byproducts-babyfood 0.059000 1.000 1.000 

5000385000 50 Turkey, fat 0.059000 1.000 1.000 

5000385001 50 Turkey, fat-babyfood 0.059000 1.000 1.000 

5000386000 50 Turkey, skin 0.059000 1.000 1.000 

5000386001 50 Turkey, skin-babyfood 0.059000 1.000 1.000 

6000301000 60 Poultry, other, meat 0.002500 1.000 1.000 

6000302000 60 Poultry, other, liver 0.006300 1.000 1.000 

6000303000 60 Poultry, other, meat byproducts 0.059000 1.000 1.000 

6000304000 60 Poultry, other, fat 0.059000 1.000 1.000 

6000305000 60 Poultry, other, skin 0.059000 1.000 1.000 

7000145000 70 Egg, whole 0.012000 1.000 1.000 

7000145001 70 Egg, whole-babyfood 0.012000 1.000 1.000 

7000146000 70 Egg, white 0.012000 1.000 1.000 

7000146001 70 Egg, white (solids)-babyfood 0.012000 1.000 1.000 

7000147000 70 Egg, yolk 0.012000 1.000 1.000 

7000147001 70 Egg, yolk-babyfood 0.012000 1.000 1.000 

8000157000 80 Fish-freshwater finfish 0.005000 1.000 1.000 FHE

8000158000 80 Fish-freshwater finfish, farm ra 0.005000 1.000 1.000 FHE

8000159000 80 Fish-saltwater finfish, tuna 0.005000 1.000 1.000 FHE

8000160000 80 Fish-saltwater finfish, other 0.005000 1.000 1.000 FHE

8000161000 80 Fish-shellfish, crustacean 0.005000 1.000 1.000 FHE

8000162000 80 Fish-shellfish, mollusc 0.005000 1.000 1.000 FHE

8601000000 86A Water, direct, all sources 0.077800 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.077800 1.000 1.000 

9500001000 O Acerola 0.005000 1.000 1.000 FHE

9500001500 O Agave 0.005000 1.000 1.000 FHE

9500006000 O Amaranth, grain 0.005000 1.000 1.000 FHE

9500016000 O Artichoke, globe 0.005000 1.000 1.000 FHE

9500019000 O Asparagus 0.005000 1.000 1.000 FHE

9500019500 O Atemoya 0.005000 1.000 1.000 FHE

9500020000 O Avocado 0.192000 1.000 1.000 

9500022000 O Bamboo, shoots 0.005000 1.000 1.000 FHE

9500023000 O Banana 0.005000 1.000 1.000 FHE

9500023001 O Banana-babyfood 0.005000 1.000 1.000 FHE

9500024000 O Banana, dried 0.005000 1.000 1.000 FHE

9500024001 O Banana, dried-babyfood 0.005000 1.000 1.000 FHE

9500054000 O Belgium endive 0.005000 1.000 1.000 FHE

9500060000 O Breadfruit 0.005000 1.000 1.000 FHE

9500073000 O Cactus 0.005000 1.000 1.000 FHE

9500074000 O Canistel 0.005000 1.000 1.000 FHE

9500077000 O Carob 0.005000 1.000 1.000 FHE

9500089000 O Cherimoya 0.005000 1.000 1.000 FHE

9500109000 O Cocoa bean, chocolate 0.005000 1.000 1.000 FHE

9500110000 O Cocoa bean, powder 0.005000 1.000 1.000 FHE

9500111000 O Coconut, meat 0.005000 1.000 1.000 FHE

9500111001 O Coconut, meat-babyfood 0.005000 1.000 1.000 FHE

9500112000 O Coconut, dried 0.005000 1.000 1.000 FHE

9500113000 O Coconut, milk 0.005000 1.000 1.000 FHE

9500114000 O Coconut, oil 0.005000 1.000 1.000 FHE

9500115000 O Coffee, roasted bean 0.005000 1.000 1.000 FHE

9500116000 O Coffee, instant 0.005000 1.000 1.000 FHE
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9500141000 O Date 0.005000 1.000 1.000 FHE

9500151000 O Feijoa 0.005000 1.000 1.000 FHE

9500153000 O Fig 0.005000 1.000 1.000 FHE

9500154000 O Fig, dried 0.005000 1.000 1.000 FHE

9500177000 O Grape, leaves 0.005000 1.000 1.000 FHE

9500178000 O Grape, raisin 0.005000 1.000 1.000 FHE

9500183000 O Guava 0.005000 1.000 1.000 FHE

9500183001 O Guava-babyfood 0.005000 1.000 1.000 FHE

9500186000 O Honey 0.005000 1.000 1.000 FHE

9500186001 O Honey-babyfood 0.005000 1.000 1.000 FHE

9500188000 O Hop 0.005000 1.000 1.000 FHE

9500193000 O Jackfruit 0.005000 1.000 1.000 FHE

9500209000 O Longan 0.005000 1.000 1.000 FHE

9500211000 O Lychee 0.005000 1.000 1.000 FHE

9500212000 O Lychee, dried 0.005000 1.000 1.000 FHE

9500214000 O Mamey apple 0.005000 1.000 1.000 FHE

9500215000 O Mango 0.005000 1.000 1.000 FHE

9500215001 O Mango-babyfood 0.005000 1.000 1.000 FHE

9500216000 O Mango, dried 0.005000 1.000 1.000 FHE

9500217000 O Mango, juice 0.005000 1.000 1.000 FHE

9500217001 O Mango, juice-babyfood 0.005000 1.000 1.000 FHE

9500218000 O Maple, sugar 0.005000 1.000 1.000 FHE

9500219000 O Maple syrup 0.005000 1.000 1.000 FHE

9500235000 O Olive 0.005000 1.000 1.000 FHE

9500236000 O Olive, oil 0.005000 1.000 1.000 FHE

9500243000 O Palm heart, leaves 0.005000 1.000 1.000 FHE

9500244000 O Palm, oil 0.005000 1.000 1.000 FHE

9500244001 O Palm, oil-babyfood 0.005000 1.000 1.000 FHE

9500245000 O Papaya 0.005000 1.000 1.000 FHE

9500245001 O Papaya-babyfood 0.005000 1.000 1.000 FHE

9500246000 O Papaya, dried 0.005000 1.000 1.000 FHE

9500247000 O Papaya, juice 0.005000 1.000 1.000 FHE

9500252000 O Passionfruit 0.005000 1.000 1.000 FHE

9500252001 O Passionfruit-babyfood 0.005000 1.000 1.000 FHE

9500253000 O Passionfruit, juice 0.005000 1.000 1.000 FHE

9500253001 O Passionfruit, juice-babyfood 0.005000 1.000 1.000 FHE

9500254000 O Pawpaw 0.005000 1.000 1.000 FHE

9500263000 O Peanut 0.010000 1.000 1.000 

9500264000 O Peanut, butter 0.010000 1.890 1.000 

9500265000 O Peanut, oil 0.010000 1.000 1.000 

9500275000 O Peppermint 0.005000 1.000 1.000 FHE

9500276000 O Peppermint, oil 0.005000 1.000 1.000 FHE

9500277000 O Persimmon 0.005000 1.000 1.000 FHE

9500279000 O Pineapple 0.005000 1.000 1.000 FHE

9500279001 O Pineapple-babyfood 0.005000 1.000 1.000 FHE

9500280000 O Pineapple, dried 0.005000 1.000 1.000 FHE

9500281000 O Pineapple, juice 0.005000 1.000 1.000 FHE

9500281001 O Pineapple, juice-babyfood 0.005000 1.000 1.000 FHE

9500283000 O Plantain 0.005000 1.000 1.000 FHE

9500284000 O Plantain, dried 0.005000 1.000 1.000 FHE

9500289000 O Pomegranate 0.005000 1.000 1.000 FHE

9500306000 O Psyllium, seed 0.005000 1.000 1.000 FHE

9500311000 O Quinoa, grain 0.005000 1.000 1.000 FHE

9500333000 O Sapote, Mamey 0.005000 1.000 1.000 FHE

9500335000 O Seaweed 0.005000 1.000 1.000 FHE

9500335001 O Seaweed-babyfood 0.005000 1.000 1.000 FHE

9500346000 O Soursop 0.005000 1.000 1.000 FHE

9500351000 O Spanish lime 0.005000 1.000 1.000 FHE

9500352000 O Spearmint 0.005000 1.000 1.000 FHE

9500353000 O Spearmint, oil 0.005000 1.000 1.000 FHE

9500358000 O Starfruit 0.005000 1.000 1.000 FHE

9500361000 O Sugar apple 0.005000 1.000 1.000 FHE

9500362000 O Sugarcane, sugar 0.125000 1.000 1.000 

9500362001 O Sugarcane, sugar-babyfood 0.125000 1.000 1.000 

9500363000 O Sugarcane, molasses 0.125000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 0.125000 1.000 1.000 

9500368000 O Tamarind 0.005000 1.000 1.000 FHE

9500372000 O Tea, dried 0.005000 1.000 1.000 FHE

9500373000 O Tea, instant 0.005000 1.000 1.000 FHE

9500373500 O Teff, flour 0.005000 1.000 1.000 FHE
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9500390000 O Vinegar 0.005000 1.000 1.000 FHE

9500397000 O Water chestnut 0.005000 1.000 1.000 FHE

9500398000 O Watercress 0.005000 1.000 1.000 FHE
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Attachment 3: DEEM-FCID Chronic Results File

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for NOVALURON NHANES 2003-2008 2-day

Residue file name: C:\Users\jlangsda\Documents\Chemicals\Novaluron\2014 Avocado, Carrot, 

Bean, Cucumber, and CG Tolerance Expansions\Dietary Memo\novaluron_chronic1_Feb 23 2015.R08

 Adjustment factor #2 used.

Analysis Date 02-23-2015/09:23:15 Residue file dated: 02-23-2015/09:22:50

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 

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

Total US Population 0.003071 27.9%

Hispanic 0.003037 27.6%

Non-Hisp-White 0.003064 27.9%

Non-Hisp-Black 0.003009 27.4%

Non-Hisp-Other 0.003412 31.0%

Nursing Infants 0.002603 23.7%

Non-Nursing Infants 0.007936 72.1%

Female 13+ PREG 0.002744 24.9%

Children 1-6 0.006410 58.3%

Children 7-12 0.003525 32.0%

Male 13-19 0.002458 22.3%

Female 13-19/NP 0.002393 21.8%

Male 20+ 0.002590 23.5%

Female 20+/NP 0.002728 24.8%

Seniors 55+ 0.002635 24.0%

All Infants 0.006289 57.2%

Female 13-50 0.002636 24.0%

Children 1-2 0.008014 72.9%

Children 3-5 0.005711 51.9%

Children 6-12 0.003746 34.1%

Youth 13-19 0.002424 22.0%

Adults 20-49 0.002659 24.2%

Adults 50-99 0.002671 24.3%

Female 13-49 0.002640 24.0%

-------------------------------------------------------------------------------
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Attachment 4: Novaluron (124002) SLUA, Date: 18 June 2014
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Attachment 5: Update of PCTn: Novaluron (124002) Use on Sorghum and Sweet Corn (C. 

Doucoure, et al., 01-FEB-2013)

The following tables summarize the PCTn recommendations from the BEAD memo, “Update of 

Percent Crop Treated for New Use (PCTn): Novaluron (124002) Use on Sorghum and Sweet 

Corn” (C. Doucoure, et al., 01-FEB-2013).” 

Table A.5.1. PCTn with Novaluron on Sorghum Based on Novaluron not Overtaking Market Leader.

Crop Year PCTn

Sorghum 2011 2%

Source: USDA NASS, Agricultural Chemical Usage Report, 2011

Table A.5.2. PCTn with Novaluron on Sweet Corn Based on Market Leaders.

Crop Year PCTn (Avg) PCTn (Max)

Sweet Corn

2009

2010 36% 37%

2011

Source: EPA Proprietary Data, 2009-2011