Diflubenzuron (PC Code I 0820 I) Dietary Exposure and Risk Assessment DP #: 427147 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Office of Chemical Safety and Pollution Prevention 

Date: 8/5/2015 

SUBJECT: Diflubenzuron. Chronic Non-Cancer and Cancer Dietary and Drinking Water 

Exposure and Risk Assessments in Support of the New Use Registration of 

Diflubenzuron f'onnulated Product on Alfalfa, Carrot, Cottonseeds Subgroup 

20C, Peach Subgroup 12-128, Plum Subgroup I 2-I 2C Peppers/Eggplant 

Subgroup 8-1 OB and Conversion for Tree Nuts Group 14-12. 

PC Code: I 0820 I 

Decision No.: 4941 16 

Petition No.: 4E8306 

DP Barcode: 427147 

Registration No.: 400-46 1 

Regulatory Action: Section 3 

Risk Assessment Type: Dietary Case No.: 0144 

TXR No.: NA CAS No: 35367-38-5 

MRID No.: NA 40 CFR: 180.377 

Revie,ver: 

Through: 

TO: 

Sumitra Bose Biswas, Chemist ~~ rJ · ~ · 

Risk Assessment Branch VI 

Health Effects Division (RABVI/HED; 7509P) 

Tom Bloem, Chemist, Designated Revie~1$.~ Thurston Morton, Chemist, Designated Reviewer < J 

Dietary Exposure Science Advisory Council (DESACf" 

And 

Donna S. Davis, Acting Chief 

Risk Assessment Branch 4, Health Effects Division (7509P) 

Andrew Ertman/Barbara Madden 

Risk Integration, Minor Use & Emergency Response Branch 

Registration Division (RD) (7505P) 

Page I of 22 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

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Executive Summary

The purpose of this memorandum is to report the results of a chronic non-cancer and cancer 

dietary exposure analysis for a Section 3 request for use of the insecticide diflubenzuron on

Alfalfa, Carrot, Cottonseeds Subgroup 20C, Peach Subgroup 12-12B, Plum Subgroup 12-12C 

Peppers/Eggplant Subgroup 8-10B and Tree Nuts Group 14-12. The chronic non-cancer and 

cancer dietary risk assessment was conducted using the Dietary Exposure Evaluation Model 

software with the Food Commodity Intake Database (DEEM-FCIDTM), Version 3.16, which 

incorporates consumption data from USDA’s National Health and Nutrition Examination 

Survey, What We Eat in America, (NHANES/WWEIA). 

This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC Standard 

Operating Procedures (SOP) 2012.1. 

Acute Dietary Exposure Results and Characterization:

No toxic effects attributable to a single (i.e., acute) exposure to diflubenzuron have been 

identified; therefore, an acute reference dose (RfD) has not been established for diflubenzuron 

and an acute dietary exposure assessment has not been conducted. 

Chronic Dietary Exposure Results and Characterization:

The slightly refined chronic dietary risk assessment for diflubenzuron shows that chronic dietary 

risk estimates do not exceed HED's level of concern (i.e. <100% chronic population adjusted 

doses (cPAD)). The results of the analysis indicate that chronic risk from the dietary (food + 

drinking water) exposure to diflubenzuron will not exceed HED’s level of concern for the 

general U.S. population, and all population subgroups. The chronic dietary risk estimate for the 

highest reported exposed population subgroup, children 1-2 years old, is 39% of the cPAD. The 

general US population utilizes 10% of the cPAD.

Cancer:

Diflubenzuron is classified as “Group E,” evidence of non-carcinogenicity for humans, therefore, 

a dietary cancer assessment is not required. However, metabolites CPU and PCA are considered 

probable carcinogens and have Q*s assigned to them. Individual cancer dietary exposure 

analyses were conducted for each metabolite.

The cancer assessment for PCA includes food only (not present in drinking water). For PCA, the 

cancer dietary exposure estimate for the U.S. population is 1.3 x 10-6. The cancer assessment for 

CPU includes milk and water only. For CPU, the cancer dietary exposure estimate for the U.S. 

population is 2.8 x 10-6.
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

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I. Introduction

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

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

(i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to 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 which discuss the acute and chronic risk assessments in 

more detail are available on the EPA/pesticides web site: “Available Information on Assessing 

Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link: 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-

AUG-1999).

The most recent dietary risk assessment for diflubenzuron was conducted by T. Morton 

(12/12/2013, 403078, 403079, and 403080).

II. Residue Information

Diflubenzuron Use:

Diflubenzuron (N-[((4-chlorophenyl)amino)carbonyl]-2,6-difluorobenzimide), a member of the 

urea-derivative chemical family, is an insecticide/acaricide (insect growth regulator) that behaves 

as a chitin inhibitor to suppress the growth of many leaf-eating larvae, mosquito larvae, aquatic 

midges, rust mite, boll weevil, and flies. 

Residues of Concern

Summary of Plant Metabolism Studies (DP# 272978, G. Kramer, 4/3/2001)

HED Metabolism Assessment Review Committee (MARC) Meetings of 2/20/2001 and 5/8/2001.

Residues of Concern for Cancer Risk Assessment (DP# 272976, G. Kramer and G. Reddy, 5/31/2001)

The qualitative nature of the residue in plants and fungi is adequately understood based on data 

from citrus, mushroom, rice, and soybean metabolism studies. The metabolism of diflubenzuron 

in crops tested is similar, and the radioactive components are also similar to those found in soil. 

The nature of the residue in livestock is also adequately understood based on acceptable poultry 

and ruminant metabolism studies reflecting oral dosing. The HED Metabolism Assessment 

Review Committee (MARC) has concluded that the residues of concern in plants and livestock, 

for the purpose of tolerance expression risk assessment, are diflubenzuron and its metabolites 4-

chlorophenylurea (CPU) and 4-chloroaniline (PCA). EFED has determined that PCA is only a 

minor metabolite of diflubenzuron in the environment (K. Costello, Personal Communication, 

2/28/01). Drinking water will thus not be considered in the risk assessment for PCA.

Parent diflubenzuron and matabolite CPU are included in the chronic non-cancer risk 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

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assessment. Individual cancer risk assessments were conducted for CPU and PCA; based on 

toxicological considerations a cancer risk assessment for parent is unnecessary.

Tolerances

Tolerances for residues of diflubenzuron are established under 40CFR §180.377. Tolerances 

listed in 40 CFR §180.377(a)(1) are expressed in terms of diflubenzuron per se. Under this 

section, current tolerances range from 0.05 ppm in/on eggs; milk; fat and meat of cattle, goat, 

hog, horse, poultry, and sheep; poultry meat bypoducts to 6.0 ppm in globe artichoke.

Tolerances listed in 40 CFR §180.377(a)(2) are expressed in terms of the combined residues of 

diflubenzuron and its metabolites 4-chlorophenylurea (CPU) and 4-chloroaniline (PCA). Under 

this section, current tolerances range from 0.02 ppm in/on rice grain to 55 ppm in peanut hay.

Time-limited tolerances listed in 40 CFR §180.377(b) are expressed in terms of the combined 

residues of diflubenzuron and its metabolites CPU and PCA, expressed as the parent 

diflubenzuron, in connection with use of the pesticide under Section 18 Emergency Exemptions 

granted by EPA. Under this section, current tolerances are established on alfalfa forage and hay 

at 6.0 ppm.

Residue Data Used for Non-Cancer Chronic and Cancer Assessments:

Based on the toxicity profile chronic non cancer run was performed considering combined 

residues of parent diflubenzuron, CPU and PCA. Cancer analysis are required only for CPU and 

PCA. Use of tolerance level residues or field trial residues which considered only parent is 

considered acceptable as residues of CPU and PCA are insignificant in comparison.

Residue Data Used for Non-Cancer Chronic Assessment:

Based on the toxicity profile, the chronic non-cancer exposure analyses includes combine 

residues of parent diflubenzuron, CPU and PCA and assumed that residues were present in all 

commodities at established recommended tolerance levels except orange (0.367 ppm), grapefruit 

(0.214 ppm) and lemon (0.653 ppm) which used average field trial residues. The chronic dietary 

exposure analysis assumed 100% of all proposed and existing crops were treated, and that 

DEEMTM Version 7.81 default processing factors were used for some processed commodities. A 

processing factor of 1x was used for citrus juices. Residue Data Used for Cancer Chronic 

Assessments (CPU)

Residue Data Used for Cancer Chronic Assessments (CPU):

A residue value of 0.003 ppm, which represents 1⁄2 the LOQ of CPU, was used for the CPU 

chronic cancer assessment for milk commodities. Diflubenzuron only metabolizes to CPU in 

milk and CPU was not found in the feeding study. Since the new uses did not greatly increase the 

diflubenzuron dairy dietary burdens, CPU is still unlikely to be found in milk and therefore 

current use of 0.003 ppm for milk continues to be justified. Residues of CPU in the remaining 

commodities is considered negligible.
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Residue Data Used for Cancer Chronic Assessments (PCA):

A residue value of 0.003 ppm was used for the PCA cancer assessment for all food commodities 

in DEEM, except mushroom. This represents 1⁄2 the LOQ of PCA. For PCA, this is due to the fact 

that the majority of current and proposed crops do not contain detectable residues of PCA and,

therefore, any PCA residues in animal products would be insignificant and consequently less than 

the currently used value of 0.003 ppm. An average residue of 0.048 ppm was used for mushroom 

residue input value in the PCA cancer assessment.

As part of the current petition, HED recommends establishing tolerances on the commodities and 

on crop groups listed in Table 1 for residues of diflubenzuron. 

Table 1. Proposed/Recommended Tolerances for Diflubenzuron

Commodity Proposed Tolerance 

(ppm)

HED-Recommended 

Tolerance (ppm)

Comments 

(correct commodity definition)

40 CFR 180.377(a)(1) Tolerance for residues.

Cottonseed subgroup 20C 0.2 0.20 Cottonseed subgroup 20C

Established tolerance for cotton, 

undelinted seed can be removed from 

40CFR and replaced by this 

subgroup tolerance.

Egg 0.15 0.07 Egg

Current tolerance level is 0.05 ppm; 

Increase to support the diflubenzuron 

uses on alfalfa.

Poultry, fat 0.15 0.10 Poultry, fat

Current tolerance level is 0.05 ppm; 

Increase to support the diflubenzuron 

uses on alfalfa.

Poultry, meat byproducts 0.06 0.08 Poultry, meat byproducts

Current tolerance level is 0.05 ppm; 

Increase to support the diflubenzuron 

uses on alfalfa.

40 CFR 180.377(a)(2) Tolerance for residues.

Carrot, roots 0.2 0.20 Carrot, roots

Peach subgroup 12-12B 0.5 0.50 Peach subgroup 12-12B

Established tolerance (0.07 ppm) for 

Fruit, stone, group 12, except cherry 

can be removed from 40CFR and 

replaced by this subgroup tolerance.

Plum subgroup 12-12C 0.5 0.50 Peach subgroup 12-12C

Established tolerance (0.07 ppm) for 

Fruit, stone, group 12, except cherry 

can be removed from 40CFR and 

replaced by this subgroup tolerance 

to harmonize with codex.
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Table 1. Proposed/Recommended Tolerances for Diflubenzuron

Commodity Proposed Tolerance 

(ppm)

HED-Recommended 

Tolerance (ppm)

Comments 

(correct commodity definition)

Nut, tree, group 14-12

0.2 0.2 Nut, tree, group 14-12

Established tolerance for Pistachio 

and Nut, tree, group 14 can be 

removed from 40CFR and replaced 

by this subgroup tolerance to 

harmonize with codex.

Pepper/Eggplant 

subgroup 8-10B

1.0 1.0 Pepper/Eggplant subgroup 8-10B

Established tolerance for pepper can 

be removed from 40CFR and 

replaced by this subgroup tolerance.

40 CFR 180.377(c) Tolerances with regional registrations.

Alfalfa, forage 6 6.0 Alfalfa, forage

Alfalfa, hay 20 20 Alfalfa, hay

Alfalfa, seed 0.9 0.9 Alfalfa, seed

III. Percent Crop Treated Information

The chronic non-cancer dietary exposure analysis used 100% crop treated while the cancer 

dietary exposure analysis used the following average percent crop treated: soybeans (1%), 

peppers (2.5%), oranges (10%), tangerines (10%), grapefruit (25%), pear (5%), apricot (10%), 

peach (5%), almond, (10%), pecan (2.5%), rice (2.5%), wheat (1%), cotton (1%), artichoke 

(45%), peanut (10%), lemon (1%), plum (5%), and walnut (2.5%).

IV. Drinking Water Data

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

Environmental Fate and Effects Division (EFED), summarized in the following memorandum: 

“Ecological Risk and Drinking Water Assessments for Proposed Label Amendments of 

Diflubenzuron.” (DP #423330, F. Khan, 04/20/2015) and incorporated directly into this dietary 

assessment. The estimated drinking water concentrations (EDWCs) of diflubenzuron and CPU 

were generated using the Surface Water Concentration Calculator model (SWCC) for surface 

water and the Pesticide Root Zone Model-Groundwater (PRZM-GW) model for ground water.

Water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all 

sources” and “water, indirect, all sources.” 

The maximum application rate of 0.312 lbs a.i./A X 3 applications/year for citrus as well as 0.25 

lbs a.i./A X 4 applications/year for tree nut were modeled with the SWCC and PRZM-GW 

models. Model input parameters were chosen according to current guidance (USEPA, 2009 and 

USEPA, 2013a). For surface water sources of drinking water, the recommended peak (acute) 

concentration of 4.61 μg/L, annual mean (non-cancer chronic) concentration of 0.41 μg/L and the 

30 year annual average concentration (cancer chronic) of 0.38 μg/L based on LV application of 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

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diflubenzuron for citrus use. For CPU, the recommended surface water concentrations are 6.83 

μg/L for acute, 0.89 μg/L for non-cancer chronic and 0.51 μg/L for cancer chronic also based on 

aerial application representative of citrus use.

For groundwater sources of drinking water, the maximum acute and chronic estimated 

concentrations of CPU in shallow groundwater from PRZM-GW model for applications to citrus 

were 8.62 μg/L and 8.02 μg/L, respectively. However, the concentrations of diflubenzuron in 

groundwater were negligible. Recommended surface water and groundwater EDWCs for human 

health are listed in Table 2.

Table 2. Drinking Water Exposure Estimates for Diflubenzuron and its Major Degradate, CPU for 

Use on Various Crops.

Source Residue

Peak 

Exposure 

(μg/L)

Annual 

Mean 

Exposure 

(μg/L)

30-year 

Average 

Exposure 

(μg/L)

Surface water1

Diflubenzur

on2 4.61 0.41 0.38

CPU2 6.83 0.89 0.51

Total 11.44 1.3 0.89

Groundwater1

Diflubenzur

on

0 --- 0

CPU 8.62 --- 8.02

Total 8.62 0 8.02

1 EDWCs generated using SWCC and PRZM-GW models for aerial LV application of 0.312 lbs a.i./A X 3 

applications for citrus use 

2 Estimated in FL Citrus scenario

V. DEEM-FCID Program and Consumption Information

A diflubenzuron chronic dietary exposure assessment was conducted using the Dietary Exposure 

Evaluation Model software with the Food Commodity Intake Database DEEM-FCIDTM, Version 

3.16, which incorporates consumption data from USDA’s National Health and Nutrition 

Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was 

conducted from 2003 to 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, but for acute 

exposure assessment are retained as individual consumption events. Based on analysis of the 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

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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 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

HED evaluated the toxicology data base for diflubenzuron and selected the following doses and 

endpoints for the chronic dietary and drinking water risk assessment.

According to the HED Metabolism Committee Meeting Memorandum of 5/31/01 (D272976),

CPU is the major degradate found in water and is a significant metabolite in milk. CPU is 

structurally related to monuron (N,N-dimethyl-CPU), a compound producing tumors of the 

kidney and liver in male rats. Given that there is no accepted mechanism of carcinogenicity for 

monuron and that CPU is major metabolite of monuron in rats, there is still concern for the 

toxicity of CPU. Thus, a literature search was conducted for any toxicity studies for CPU. As no 

pertinent information was found (Personal Communication, Alberto Protzel, 5/8/01), therefore,

for carcinogenic effects, a Q1* will be calculated for monuron and applied to CPU to assess the 

risk from CPU.

In summary, Cancer risks for CPU and PCA will be assessed individually. The tolerance 

expression should include parent, PCA and CPU. Although CPU is not of concern for the 

endpoints currently regulated for DFB, it is a major metabolite in milk and the major degradate 

found in water, with potential toxicity concerns.

Therefore, a cancer assessment for CPU milk and water was conducted using a Q* of 1.52 x 10-2.

In addition, a cancer assessment for PCA food only was conducted using a Q* of 1.12 x 10-1.

Table 3 provides a summary of the toxicological doses and endpoints for trinexapac-ethyl for use 

in the dietary exposure assessment. 
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Table 3. Summary of Toxicological Doses and Endpoints for Diflubenzuron, CPU and PCA for use in Human 

Health Risk Assessments.

Exposure

Scenario

Dose Used in Risk 

Assessment, UF

FQPA SF and 

LOC for Risk 

Assessment

Study and Toxicological Effects

Acute Dietary

all populations

Not Applicable Not Applicable No appropriate endpoint attributable to single 

exposure was available in oral studies. Therefore, a 

risk assessment is not required.

Chronic Dietary

all populations

NOAEL= 2 mg/kg/day

UF = 100

Chronic RfD = 

0.02 mg/kg/day

FQPA SF = 1x

cPAD = 

chronic RfD

FQPA SF

= 0.02 mg/kg/day

Chronic Toxicity Study - Dog

LOAEL = 10 mg/kg/day based on 

methemoglobinemia and sulfhemoglobinemia

Cancer (oral, dermal, 

inhalation)

Diflubenzuron

Not Required

Not Applicable Acceptable oral rat and mouse carcinogenicity 

studies; no evidence of carcinogenic or mutagenic 

potential. “Group E” evidence of noncarcinogenicity for humans.

Cancer (oral, dermal, 

inhalation)

PCA “Group B2" 

probably human 

carcinogen

Q1

* 1.12 x 10-1

(mg/kg/day)-1

Not Applicable NTP Oral mouse study

Cancer (oral, dermal, 

inhalation)

CPU Q1

* based on 

monuron a structural 

analog and the Q1

*1.52 

x 10-2

Not Applicable NTP Oral rat study

1. UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = 

lowest observed adverse effect level, cPAD = chronic population adjusted dose, RfD = reference dose, MOE = 

margin of exposure, LOC = level of concern.

2. Conversion from mg/L to oral dose (mg/k/day)

VII. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure of the U.S. 

population and various population subgroups. The results reported in Table 4 are for the general 

U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

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females 13-49, adults 20-49, and adults 50-99 years. The results reported in Tables 5 and 6 are 

for the general U.S. Population.

For the general population, there were no appropriate toxicological effects attributable to a single 

exposure (dose); therefore, an acute dose and endpoint were not identified for this risk 

assessment. Diflubenzuron has been classified as having “evidence of non-carcinogenicity for 

humans”; therefore, quantification of human cancer risk is not required and a cancer dietary 

assessment was not performed.

Results of the Chronic Non-cancer Dietary Exposure Analysis:

The chronic dietary exposure for food and surface water utilized 11% of the cPAD for the U.S. 

population. The chronic dietary exposure for the highest exposed population subgroup, children 

1-2 years old, was 38% of the cPAD.

Table 4. Summary of Dietary (Food and Drinking Water) Exposure and Risk for Diflubenzuron

Population Subgroup

Acute Dietary

(95 Percentile) 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

No toxic effects 

attributable to a single 

(i.e., acute) exposure to 

diflubenzuron have been 

identified; therefore, an 

acute reference dose 

(RfD) has not been 

established for 

diflubenzuron and an 

acute dietary exposure 

assessment has not been 

conducted.

0.002056 10

Diflubenzuron is 

classified as “Group E,” 

evidence of noncarcinogenicity for 

humans, therefore, a 

dietary cancer assessment 

is not required.

All Infants (< 1 year old) 0.002667 13

Children 1-2 years old 0.007726 39

Children 3-5 years old 0.005705 29

Children 6-12 years old 0.002977 15

Youth 13-19 years old 0.001709 9

Adults 20-49 years old 0.001509 8

Adults 50-99 years old 0.001584 8

Females 13-49 years old 0.001497 8

*The values for the highest exposed population for each type of risk assessment should be bolded

Results of the Chronic Cancer Dietary Exposure Analysis (CPU and PCA):

For PCA, the cancer dietary exposure estimate for the U.S. population is 1.3 x 10-6. For CPU, 

the cancer dietary exposure estimate for the U.S. population is 2.8 x 10-6.
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Table 5. Summary of Dietary (Milk and Drinking Water) Exposure and Risk for Metabolite CPU

Population Subgroup

Acute Dietary

(95 Percentile) 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 NA NA 0.000187 2.8 x 10-6

Table 6. Summary of Dietary (Food Only) Exposure and Risk for Metabolite PCA

Population Subgroup

Acute Dietary

(95 Percentile) 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 NA NA 0.000011 1.3 x 10-6

VIII. Characterization of Inputs/Outputs

The chronic non-cancer analysis is slightly refined dietary exposure assessment. Average field 

trial residues were used for orange, grapefruit, and lemon. Tolerance level residues were used for 

all remaining commodities. Further refinement to the analysis could be made through the use of 

anticipated residues, incorporation of percent crop treated information for diflubenzuron and/or 

monitoring data that better reflect residues at the time of consumption. The PCA chronic cancer 

analysis is moderately refined. Percent crop treated information was used in the chronic cancer 

dietary exposure analysis. Since most field trials showed non-detectable residues for PCA 1⁄2 

LOD was used for the residue input. For the CPU analysis, 1⁄2 LOD was also used for milk 

residues.

IX. Conclusions

Chronic dietary exposure analyses were performed for the general U.S. population and various 

population subgroups. The chronic non-cancer risk estimates for the general U.S. population and 

all population subgroups are below HED’s level of concern (10%). HED is confident that chronic 

dietary exposures to diflubenzuron are not underestimated. For PCA, the cancer dietary exposure 

estimate for the U.S. population is 1.3 x 10-6. For CPU, the cancer dietary exposure estimate for 

the U.S. population is 2.8 x 10-6.
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X. List of Attachments

1. Chronic DEEM-FCID Residue Input File.

2. Results of Chronic DEEM-FCID Dietary Exposure Analysis.

3. Cancer CPU DEEM-FCID Residue Input File.

4. Cancer PCA DEEM-FCID Residue Input File.

5. Results of Cancer CPU DEEM-FCID Dietary Exposure Analysis 

6. Results of Cancer PCA DEEM-FCID Dietary Exposure Analysis 

7. Screening Level Estimates of Agricultural Uses of Diflubenzuron
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Attachment 1 Chronic DEEM-FCID Residue Input File

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for DIFLUBENZURON

Residue file: C:\Users\sbiswas\Desktop\DEEM file\CHRONIC with PDP fish7-30-2015.R08

 Adjust. #2 NOT used

Analysis Date 07-30-2015 Residue file dated: 07-30-2015/18:17:42

Reference dose (RfD) = 0.02 (NOEL) = 2 mg/kg bw/day

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

Food Crop Residue Adj.Factors

EPA Code Grp Food Name (ppm) #1 #2 

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

1800002000 18 Alfalfa, seed 0.900000 1.000 1.000 

1400003000 14 Almond 0.200000 1.000 1.000 

1400003001 14 Almond-babyfood 0.200000 1.000 1.000 

1400004000 14 Almond, oil 0.200000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.200000 1.000 1.000 

1202012000 12B Apricot 0.500000 1.000 1.000 

1202012001 12B Apricot-babyfood 0.500000 1.000 1.000 

1202013000 12B Apricot, dried 0.500000 6.000 1.000 

1202014000 12B Apricot, juice 0.500000 1.000 1.000 

1202014001 12B Apricot, juice-babyfood 0.500000 1.000 1.000 

9500016000 O Artichoke, globe 6.000000 1.000 1.000 

1500025000 15 Barley, pearled barley 0.060000 1.000 1.000 

1500025001 15 Barley, pearled barley-babyfood 0.060000 1.000 1.000 

1500026000 15 Barley, flour 0.060000 1.000 1.000 

1500026001 15 Barley, flour-babyfood 0.060000 1.000 1.000 

1500027000 15 Barley, bran 0.060000 1.000 1.000 

3100044000 31 Beef, meat 0.050000 1.000 1.000 

3100044001 31 Beef, meat-babyfood 0.050000 1.000 1.000 

3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 

3100046000 31 Beef, meat byproducts 0.150000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.150000 1.000 1.000 

3100047000 31 Beef, fat 0.050000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.050000 1.000 1.000 

3100048000 31 Beef, kidney 0.150000 1.000 1.000 

3100049000 31 Beef, liver 0.150000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 0.150000 1.000 1.000 

1400059000 14 Brazil nut 0.200000 1.000 1.000 

0502063000 5B Broccoli raab 9.000000 1.000 1.000 

1400068000 14 Butternut 0.200000 1.000 1.000 

0502070000 5B Cabbage, Chinese, bok choy 9.000000 1.000 1.000 

0101078000 1AB Carrot 0.200000 1.000 1.000 

0101078001 1AB Carrot-babyfood 0.200000 1.000 1.000 

0101079000 1AB Carrot, juice 0.200000 1.000 1.000 

1400081000 14 Cashew 0.200000 1.000 1.000 

1400092000 14 Chestnut 0.200000 1.000 1.000 

4000093000 40 Chicken, meat 0.050000 1.000 1.000 

4000093001 40 Chicken, meat-babyfood 0.050000 1.000 1.000 

4000094000 40 Chicken, liver 0.050000 1.000 1.000 

4000095000 40 Chicken, meat byproducts 0.050000 1.000 1.000 

4000095001 40 Chicken, meat byproducts-babyfoo 0.050000 1.000 1.000 

4000096000 40 Chicken, fat 0.050000 1.000 1.000 

4000096001 40 Chicken, fat-babyfood 0.050000 1.000 1.000 

4000097000 40 Chicken, skin 0.050000 1.000 1.000 

4000097001 40 Chicken, skin-babyfood 0.050000 1.000 1.000 

1001106000 10A Citron 3.000000 1.000 1.000 

1001107000 10A Citrus hybrids 3.000000 1.000 1.000 

1001108000 10A Citrus, oil 32.000000 1.000 1.000 

9500111000 O Coconut, meat 0.200000 1.000 1.000 

9500111001 O Coconut, meat-babyfood 0.200000 1.000 1.000 

9500112000 O Coconut, dried 0.200000 1.000 1.000 

9500113000 O Coconut, milk 0.200000 1.000 1.000 

9500114000 O Coconut, oil 0.200000 1.000 1.000 

2003114001 20C Coconut, oil-babyfood 0.200000 1.000 1.000 

0502117000 5B Collards 9.000000 1.000 1.000 

2003128000 20C Cottonseed, oil 0.200000 1.000 1.000 

2003128001 20C Cottonseed, oil-babyfood 0.200000 1.000 1.000 

7000145000 70 Egg, whole 0.100000 1.000 1.000 

7000145001 70 Egg, whole-babyfood 0.100000 1.000 1.000 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

Page 14 of 22

7000146000 70 Egg, white 0.100000 1.000 1.000 

7000146001 70 Egg, white (solids)-babyfood 0.100000 1.000 1.000 

7000147000 70 Egg, yolk 0.100000 1.000 1.000 

7000147001 70 Egg, yolk-babyfood 0.100000 1.000 1.000 

1400155000 14 Hazelnut 0.200000 1.000 1.000 

1400156000 14 Hazelnut, oil 0.200000 1.000 1.000 

8000157000 80 Fish-freshwater finfish 0.018000 1.000 1.000 

8000158000 80 Fish-freshwater finfish, farm ra 0.018000 1.000 1.000 

3200169000 32 Goat, meat 0.050000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.150000 1.000 1.000 

3200171000 32 Goat, fat 0.050000 1.000 1.000 

3200172000 32 Goat, kidney 0.150000 1.000 1.000 

3200173000 32 Goat, liver 0.150000 1.000 1.000 

1003180000 10C Grapefruit 0.214000 2.100 1.000 

1003181000 10C Grapefruit, juice 0.214000 2.100 1.000 

1400185000 14 Hickory nut 0.200000 1.000 1.000 

3300189000 33 Horse, meat 0.050000 1.000 1.000 

0502194000 5B Kale 9.000000 1.000 1.000 

1002197000 10B Kumquat 3.000000 1.000 1.000 

1002199000 10B Lemon 0.653000 2.000 1.000 

1002200000 10B Lemon, juice 0.653000 2.000 1.000 

1002200001 10B Lemon, juice-babyfood 0.653000 2.000 1.000 

1002201000 10B Lemon, peel 0.653000 1.000 1.000 

1002206000 10B Lime 3.000000 1.000 1.000 

1002207000 10B Lime, juice 3.000000 2.000 1.000 

1002207001 10B Lime, juice-babyfood 3.000000 1.000 1.000 

1400213000 14 Macadamia nut 0.200000 1.000 1.000 

3800221000 38 Meat, game 0.050000 1.000 1.000 

3600222000 36 Milk, fat 0.050000 1.000 1.000 

3600222001 36 Milk, fat-baby food/infant formu 0.050000 1.000 1.000 

3600223000 36 Milk, nonfat solids 0.050000 1.000 1.000 

3600223001 36 Milk, nonfat solids-baby food/in 0.050000 1.000 1.000 

3600224000 36 Milk, water 0.050000 1.000 1.000 

3600224001 36 Milk, water-babyfood/infant form 0.050000 1.000 1.000 

3600225001 36 Milk, sugar (lactose)-baby food/ 0.050000 1.000 1.000 

2100228000 21 Mushroom 0.200000 1.000 1.000 

0502229000 5B Mustard greens 9.000000 1.000 1.000 

1202230000 12B Nectarine 0.500000 1.000 1.000 

1500231000 15 Oat, bran 0.060000 1.000 1.000 

1500232000 15 Oat, flour 0.060000 1.000 1.000 

1500232001 15 Oat, flour-babyfood 0.060000 1.000 1.000 

1500233000 15 Oat, groats/rolled oats 0.060000 1.000 1.000 

1500233001 15 Oat, groats/rolled oats-babyfood 0.060000 1.000 1.000 

1001240000 10A Orange 0.367000 1.000 1.000 

1001241000 10A Orange, juice 0.367000 1.800 1.000 

1001241001 10A Orange, juice-babyfood 0.367000 1.800 1.000 

1001242000 10A Orange, peel 0.367000 1.000 1.000 

1202260000 12B Peach 0.500000 1.000 1.000 

1202260001 12B Peach-babyfood 0.500000 1.000 1.000 

1202261000 12B Peach, dried 0.500000 7.000 1.000 

1202261001 12B Peach, dried-babyfood 0.500000 7.000 1.000 

1202262000 12B Peach, juice 0.500000 1.000 1.000 

1202262001 12B Peach, juice-babyfood 0.500000 1.000 1.000 

9500263000 O Peanut 0.100000 1.000 1.000 

9500264000 O Peanut, butter 0.100000 1.890 1.000 

9500265000 O Peanut, oil 0.200000 1.000 1.000 

1100266000 11 Pear 0.500000 1.000 1.000 

1100266001 11 Pear-babyfood 0.500000 1.000 1.000 

1100267000 11 Pear, dried 0.500000 6.250 1.000 

1100268000 11 Pear, juice 0.500000 1.000 1.000 

1100268001 11 Pear, juice-babyfood 0.500000 1.000 1.000 

1400269000 14 Pecan 0.200000 1.000 1.000 

0802270000 8B Pepper, bell 1.000000 1.000 1.000 

0802270001 8B Pepper, bell-babyfood 1.000000 1.000 1.000 

0802271000 8B Pepper, bell, dried 1.000000 1.000 1.000 

0802271001 8B Pepper, bell, dried-babyfood 1.000000 1.000 1.000 

0802272000 8BC Pepper, nonbell 1.000000 1.000 1.000 

0802272001 8BC Pepper, nonbell-babyfood 1.000000 1.000 1.000 

0802273000 8BC Pepper, nonbell, dried 1.000000 1.000 1.000 

1400278000 14 Pine nut 0.200000 1.000 1.000 

1400282000 14 Pistachio 0.200000 1.000 1.000 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

Page 15 of 22

1203285000 12C Plum 0.500000 1.000 1.000 

1203285001 12C Plum-babyfood 0.500000 1.000 1.000 

1203286000 12C Plum, prune, fresh 0.500000 1.000 1.000 

1203286001 12C Plum, prune, fresh-babyfood 0.500000 1.000 1.000 

1203287000 12C Plum, prune, dried 0.500000 5.000 1.000 

1203287001 12C Plum, prune, dried-babyfood 0.500000 5.000 1.000 

1203288000 12C Plum, prune, juice 0.500000 1.400 1.000 

1203288001 12C Plum, prune, juice-babyfood 0.500000 1.400 1.000 

3400290000 34 Pork, meat 0.050000 1.000 1.000 

3400290001 34 Pork, meat-babyfood 0.050000 1.000 1.000 

3400291000 34 Pork, skin 0.050000 1.000 1.000 

3400292000 34 Pork, meat byproducts 0.150000 1.000 1.000 

3400292001 34 Pork, meat byproducts-babyfood 0.150000 1.000 1.000 

3400293000 34 Pork, fat 0.050000 1.000 1.000 

3400293001 34 Pork, fat-babyfood 0.050000 1.000 1.000 

3400294000 34 Pork, kidney 0.150000 1.000 1.000 

3400295000 34 Pork, liver 0.150000 1.000 1.000 

6000301000 60 Poultry, other, meat 0.050000 1.000 1.000 

6000302000 60 Poultry, other, liver 0.080000 1.000 1.000 

6000303000 60 Poultry, other, meat byproducts 0.080000 1.000 1.000 

6000304000 60 Poultry, other, fat 0.100000 1.000 1.000 

6000305000 60 Poultry, other, skin 0.050000 1.000 1.000 

1003307000 10C Pummelo 3.000000 1.000 1.000 

3900312000 39 Rabbit, meat 0.050000 1.000 1.000 

0502318000 5B Rape greens 9.000000 1.000 1.000 

1500323000 15 Rice, white 0.020000 1.000 1.000 

1500323001 15 Rice, white-babyfood 0.020000 1.000 1.000 

1500324000 15 Rice, brown 0.020000 1.000 1.000 

1500324001 15 Rice, brown-babyfood 0.020000 1.000 1.000 

1500325000 15 Rice, flour 0.020000 1.000 1.000 

1500325001 15 Rice, flour-babyfood 0.020000 1.000 1.000 

1500326000 15 Rice, bran 0.020000 1.000 1.000 

1500326001 15 Rice, bran-babyfood 0.020000 1.000 1.000 

3500339000 35 Sheep, meat 0.050000 1.000 1.000 

3500339001 35 Sheep, meat-babyfood 0.050000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.150000 1.000 1.000 

3500341000 35 Sheep, fat 0.050000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.050000 1.000 1.000 

3500342000 35 Sheep, kidney 0.150000 1.000 1.000 

3500343000 35 Sheep, liver 0.150000 1.000 1.000 

0600347000 6 Soybean, seed 0.050000 1.000 1.000 

0603348000 6C Soybean, flour 0.050000 1.000 1.000 

0603348001 6C Soybean, flour-babyfood 0.050000 1.000 1.000 

0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 

0600349001 6 Soybean, soy milk-babyfood or in 0.050000 1.000 1.000 

0600350000 6 Soybean, oil 0.050000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 0.050000 1.000 1.000 

1001369000 10A Tangerine 2.300000 1.000 1.000 

1001370000 10A Tangerine, juice 3.000000 2.300 1.000 

5000382000 50 Turkey, meat 0.050000 1.000 1.000 

5000382001 50 Turkey, meat-babyfood 0.050000 1.000 1.000 

5000383000 50 Turkey, liver 0.050000 1.000 1.000 

5000383001 50 Turkey, liver-babyfood 0.050000 1.000 1.000 

5000384000 50 Turkey, meat byproducts 0.050000 1.000 1.000 

5000384001 50 Turkey, meat byproducts-babyfood 0.050000 1.000 1.000 

5000385000 50 Turkey, fat 0.050000 1.000 1.000 

5000385001 50 Turkey, fat-babyfood 0.050000 1.000 1.000 

5000386000 50 Turkey, skin 0.050000 1.000 1.000 

5000386001 50 Turkey, skin-babyfood 0.050000 1.000 1.000 

0502389000 5B Turnip, greens 9.000000 1.000 1.000 

1400391000 14 Walnut 0.200000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.001300 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.001300 1.000 1.000 

1500401000 15 Wheat, grain 0.060000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 0.060000 1.000 1.000 

1500402000 15 Wheat, flour 0.060000 1.000 1.000 

1500402001 15 Wheat, flour-babyfood 0.060000 1.000 1.000 

1500403000 15 Wheat, germ 0.060000 1.000 1.000 

1500404000 15 Wheat, bran 0.060000 1.000 1.000 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

Page 16 of 22

Attachment 2 Results of Chronic DEEM-FCID Dietary Exposure Analysis

Analysis Date 07-30-2015/18:33:38 Residue file dated: 07-30-2015/18:17:42

Reference dose (RfD, Chronic) = .02 mg/kg bw/day

NOEL (Chronic) = 2 mg/kg bw/day

===============================================================================

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Margin of Percent 

 Subgroup body wt/day Exposure of RfD 

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

Total US Population 0.002056 973 10.3%

Hispanic 0.002594 771 13.0%

Non-Hisp-White 0.001800 1,111 9.0%

Non-Hisp-Black 0.002764 724 13.8%

Non-Hisp-Other 0.002400 833 12.0%

Nursing Infants 0.001533 1,305 7.7%

Non-Nursing Infants 0.003174 630 15.9%

Female 13+ PREG 0.002258 886 11.3%

Children 1-6 0.006193 323 31.0%

Children 7-12 0.002739 730 13.7%

Male 13-19 0.001895 1,055 9.5%

Female 13-19/NP 0.001558 1,284 7.8%

Male 20+ 0.001547 1,293 7.7%

Female 20+/NP 0.001509 1,325 7.5%

Seniors 55+ 0.001563 1,279 7.8%

All Infants 0.002667 750 13.3%

Female 13-50 0.001508 1,327 7.5%

Children 1-2 0.007726 259 38.6%

Children 3-5 0.005705 351 28.5%

Children 6-12 0.002977 672 14.9%

Youth 13-19 0.001723 1,161 8.6%

Adults 20-49 0.001509 1,325 7.5%

Adults 50-99 0.001584 1,263 7.9%

Female 13-49 0.001497 1,336 7.5%

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

Attachment 3 Cancer DEEM-FCID Residue Input File For CPU

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for DIFLUBENZURON

Residue file: C:\Users\sbiswas\Desktop\DEEM file\CPU Cancer Milk And Water.R08

 Adjust. #2 used

Analysis Date 07-20-2015 Residue file dated: 07-16-2015/15:08:36

Q* = 0.0152

Comment:CPU Q*

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

Food Crop Residue Adj.Factors

EPA Code Grp Food Name (ppm) #1 #2 

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

3600222000 36 Milk, fat 0.003000 1.000 1.000 

3600222001 36 Milk, fat-baby food/infant formu 0.003000 1.000 1.000 

3600223000 36 Milk, nonfat solids 0.003000 1.000 1.000 

3600223001 36 Milk, nonfat solids-baby food/in 0.003000 1.000 1.000 

3600224000 36 Milk, water 0.003000 1.000 1.000 

3600224001 36 Milk, water-babyfood/infant form 0.003000 1.000 1.000 

3600225001 36 Milk, sugar (lactose)-baby food/ 0.003000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.008020 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.008020 1.000 1.000 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

Page 17 of 22

Attachment 4 Cancer DEEM-FCID Residue Input File For PCA

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for DIFLUBENZURON

Residue file: C:\Users\sbiswas\Desktop\DEEM file\PCA Cancer Food half loq with PDP 

fish_newpercent CT 7-30-2015.R08

 Adjust. #2 used

Analysis Date 07-30-2015 Residue file dated: 07-30-2015/18:32:39

Q* = 0.112

Comment:PCA Q*

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

Food Crop Residue Adj.Factors

EPA Code Grp Food Name (ppm) #1 #2 

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

1800002000 18 Alfalfa, seed 0.003000 1.000 1.000 

1400003000 14 Almond 0.003000 1.000 0.100 

1400003001 14 Almond-babyfood 0.003000 1.000 0.100 

1400004000 14 Almond, oil 0.003000 1.000 0.100 

1400004001 14 Almond, oil-babyfood 0.003000 1.000 0.100 

1202012000 12B Apricot 0.003000 1.000 0.100 

1202012001 12B Apricot-babyfood 0.003000 1.000 0.100 

1202013000 12B Apricot, dried 0.003000 6.000 0.100 

1202014000 12B Apricot, juice 0.003000 1.000 0.100 

1202014001 12B Apricot, juice-babyfood 0.003000 1.000 0.100 

9500016000 O Artichoke, globe 0.003000 1.000 0.450 

1500025000 15 Barley, pearled barley 0.003000 1.000 1.000 

1500025001 15 Barley, pearled barley-babyfood 0.003000 1.000 1.000 

1500026000 15 Barley, flour 0.003000 1.000 1.000 

1500026001 15 Barley, flour-babyfood 0.003000 1.000 1.000 

1500027000 15 Barley, bran 0.003000 1.000 1.000 

3100044000 31 Beef, meat 0.003000 1.000 1.000 

3100044001 31 Beef, meat-babyfood 0.003000 1.000 1.000 

3100045000 31 Beef, meat, dried 0.003000 1.920 1.000 

3100046000 31 Beef, meat byproducts 0.003000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.003000 1.000 1.000 

3100047000 31 Beef, fat 0.003000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.003000 1.000 1.000 

3100048000 31 Beef, kidney 0.003000 1.000 1.000 

3100049000 31 Beef, liver 0.003000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 0.003000 1.000 1.000 

1400059000 14 Brazil nut 0.003000 1.000 1.000 

0502063000 5B Broccoli raab 0.003000 1.000 1.000 

1400068000 14 Butternut 0.003000 1.000 1.000 

0502070000 5B Cabbage, Chinese, bok choy 0.003000 1.000 1.000 

0101078000 1AB Carrot 0.003000 1.000 1.000 

0101078001 1AB Carrot-babyfood 0.003000 1.000 1.000 

0101079000 1AB Carrot, juice 0.003000 1.000 1.000 

1400081000 14 Cashew 0.003000 1.000 1.000 

1400092000 14 Chestnut 0.003000 1.000 1.000 

4000093000 40 Chicken, meat 0.003000 1.000 1.000 

4000093001 40 Chicken, meat-babyfood 0.003000 1.000 1.000 

4000094000 40 Chicken, liver 0.003000 1.000 1.000 

4000095000 40 Chicken, meat byproducts 0.003000 1.000 1.000 

4000095001 40 Chicken, meat byproducts-babyfoo 0.003000 1.000 1.000 

4000096000 40 Chicken, fat 0.003000 1.000 1.000 

4000096001 40 Chicken, fat-babyfood 0.003000 1.000 1.000 

4000097000 40 Chicken, skin 0.003000 1.000 1.000 

4000097001 40 Chicken, skin-babyfood 0.003000 1.000 1.000 

1001106000 10A Citron 0.003000 1.000 1.000 

1001107000 10A Citrus hybrids 0.003000 1.000 1.000 

1001108000 10A Citrus, oil 0.003000 1.000 1.000 

9500111000 O Coconut, meat 0.030000 1.000 1.000 

9500111001 O Coconut, meat-babyfood 0.030000 1.000 1.000 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

Page 18 of 22

9500112000 O Coconut, dried 0.030000 1.000 1.000 

9500113000 O Coconut, milk 0.030000 1.000 1.000 

9500114000 O Coconut, oil 0.030000 1.000 1.000 

2003114001 20C Coconut, oil-babyfood 0.030000 1.000 1.000 

0502117000 5B Collards 0.003000 1.000 1.000 

2003128000 20C Cottonseed, oil 0.003000 1.000 0.010 

2003128001 20C Cottonseed, oil-babyfood 0.003000 1.000 0.010 

7000145000 70 Egg, whole 0.003000 1.000 1.000 

7000145001 70 Egg, whole-babyfood 0.003000 1.000 1.000 

7000146000 70 Egg, white 0.003000 1.000 1.000 

7000146001 70 Egg, white (solids)-babyfood 0.003000 1.000 1.000 

7000147000 70 Egg, yolk 0.003000 1.000 1.000 

7000147001 70 Egg, yolk-babyfood 0.003000 1.000 1.000 

1400155000 14 Hazelnut 0.003000 1.000 1.000 

1400156000 14 Hazelnut, oil 0.003000 1.000 1.000 

8000157000 80 Fish-freshwater finfish 0.018000 1.000 1.000 

8000158000 80 Fish-freshwater finfish, farm ra 0.018000 1.000 1.000 

3200169000 32 Goat, meat 0.003000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.003000 1.000 1.000 

3200171000 32 Goat, fat 0.003000 1.000 1.000 

3200172000 32 Goat, kidney 0.003000 1.000 1.000 

3200173000 32 Goat, liver 0.003000 1.000 1.000 

1003180000 10C Grapefruit 0.003000 1.000 0.250 

1003181000 10C Grapefruit, juice 0.003000 1.000 0.250 

1400185000 14 Hickory nut 0.003000 1.000 1.000 

3300189000 33 Horse, meat 0.003000 1.000 1.000 

0502194000 5B Kale 0.003000 1.000 1.000 

1002197000 10B Kumquat 0.003000 1.000 1.000 

1002199000 10B Lemon 0.003000 1.000 0.010 

1002200000 10B Lemon, juice 0.003000 1.000 0.010 

1002200001 10B Lemon, juice-babyfood 0.003000 1.000 0.010 

1002201000 10B Lemon, peel 0.003000 1.000 0.010 

1002206000 10B Lime 0.003000 1.000 1.000 

1002207000 10B Lime, juice 0.003000 1.000 1.000 

1002207001 10B Lime, juice-babyfood 0.003000 1.000 1.000 

1400213000 14 Macadamia nut 0.003000 1.000 1.000 

3800221000 38 Meat, game 0.003000 1.000 1.000 

2100228000 21 Mushroom 0.048000 1.000 1.000 

0502229000 5B Mustard greens 0.003000 1.000 1.000 

1202230000 12B Nectarine 0.003000 1.000 1.000 

1500231000 15 Oat, bran 0.003000 1.000 1.000 

1500232000 15 Oat, flour 0.003000 1.000 1.000 

1500232001 15 Oat, flour-babyfood 0.003000 1.000 1.000 

1500233000 15 Oat, groats/rolled oats 0.003000 1.000 1.000 

1500233001 15 Oat, groats/rolled oats-babyfood 0.003000 1.000 1.000 

1001240000 10A Orange 0.003000 1.000 0.100 

1001241000 10A Orange, juice 0.003000 1.000 0.100 

1001241001 10A Orange, juice-babyfood 0.003000 1.000 0.100 

1001242000 10A Orange, peel 0.003000 1.000 0.100 

1202260000 12B Peach 0.003000 1.000 0.050 

1202260001 12B Peach-babyfood 0.003000 1.000 0.050 

1202261000 12B Peach, dried 0.003000 7.000 0.050 

1202261001 12B Peach, dried-babyfood 0.003000 7.000 0.050 

1202262000 12B Peach, juice 0.003000 1.000 0.050 

1202262001 12B Peach, juice-babyfood 0.003000 1.000 0.050 

9500263000 O Peanut 0.003000 1.000 0.100 

9500264000 O Peanut, butter 0.003000 1.890 0.100 

9500265000 O Peanut, oil 0.003000 1.000 0.100 

1100266000 11 Pear 0.003000 1.000 0.050 

1100266001 11 Pear-babyfood 0.003000 1.000 0.050 

1100267000 11 Pear, dried 0.003000 6.250 0.050 

1100268000 11 Pear, juice 0.003000 1.000 0.050 

1100268001 11 Pear, juice-babyfood 0.003000 1.000 0.050 

1400269000 14 Pecan 0.003000 1.000 0.025 

0802270000 8B Pepper, bell 0.003000 1.000 0.025 

0802270001 8B Pepper, bell-babyfood 0.003000 1.000 0.025 

0802271000 8B Pepper, bell, dried 0.003000 1.000 0.025 

0802271001 8B Pepper, bell, dried-babyfood 0.003000 1.000 0.025 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

Page 19 of 22

0802272000 8BC Pepper, nonbell 0.003000 1.000 0.025 

0802272001 8BC Pepper, nonbell-babyfood 0.003000 1.000 0.025 

0802273000 8BC Pepper, nonbell, dried 0.003000 1.000 0.025 

1400278000 14 Pine nut 0.003000 1.000 1.000 

1400282000 14 Pistachio 0.003000 1.000 1.000 

1203285000 12C Plum 0.003000 1.000 0.050 

1203285001 12C Plum-babyfood 0.003000 1.000 0.050 

1203286000 12C Plum, prune, fresh 0.003000 1.000 0.050 

1203286001 12C Plum, prune, fresh-babyfood 0.003000 1.000 0.050 

1203287000 12C Plum, prune, dried 0.003000 5.000 0.050 

1203287001 12C Plum, prune, dried-babyfood 0.003000 5.000 0.050 

1203288000 12C Plum, prune, juice 0.003000 1.400 0.050 

1203288001 12C Plum, prune, juice-babyfood 0.003000 1.400 0.050 

3400290000 34 Pork, meat 0.003000 1.000 1.000 

3400290001 34 Pork, meat-babyfood 0.003000 1.000 1.000 

3400291000 34 Pork, skin 0.003000 1.000 1.000 

3400292000 34 Pork, meat byproducts 0.003000 1.000 1.000 

3400292001 34 Pork, meat byproducts-babyfood 0.003000 1.000 1.000 

3400293000 34 Pork, fat 0.003000 1.000 1.000 

3400293001 34 Pork, fat-babyfood 0.003000 1.000 1.000 

3400294000 34 Pork, kidney 0.003000 1.000 1.000 

3400295000 34 Pork, liver 0.003000 1.000 1.000 

6000301000 60 Poultry, other, meat 0.003000 1.000 1.000 

6000302000 60 Poultry, other, liver 0.003000 1.000 1.000 

6000303000 60 Poultry, other, meat byproducts 0.003000 1.000 1.000 

6000304000 60 Poultry, other, fat 0.003000 1.000 1.000 

6000305000 60 Poultry, other, skin 0.003000 1.000 1.000 

1003307000 10C Pummelo 0.003000 1.000 1.000 

3900312000 39 Rabbit, meat 0.003000 1.000 1.000 

0502318000 5B Rape greens 0.003000 1.000 1.000 

1500323000 15 Rice, white 0.003000 1.000 0.025 

1500323001 15 Rice, white-babyfood 0.003000 1.000 0.025 

1500324000 15 Rice, brown 0.003000 1.000 0.025 

1500324001 15 Rice, brown-babyfood 0.003000 1.000 0.025 

1500325000 15 Rice, flour 0.003000 1.000 0.025 

1500325001 15 Rice, flour-babyfood 0.003000 1.000 0.025 

1500326000 15 Rice, bran 0.003000 1.000 0.025 

1500326001 15 Rice, bran-babyfood 0.003000 1.000 0.025 

3500339000 35 Sheep, meat 0.003000 1.000 1.000 

3500339001 35 Sheep, meat-babyfood 0.003000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.003000 1.000 1.000 

3500341000 35 Sheep, fat 0.003000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.003000 1.000 1.000 

3500342000 35 Sheep, kidney 0.003000 1.000 1.000 

3500343000 35 Sheep, liver 0.003000 1.000 1.000 

0600347000 6 Soybean, seed 0.003000 1.000 0.010 

0603348000 6C Soybean, flour 0.003000 1.000 0.010 

0603348001 6C Soybean, flour-babyfood 0.003000 1.000 0.010 

0600349000 6 Soybean, soy milk 0.003000 1.000 0.010 

0600349001 6 Soybean, soy milk-babyfood or in 0.003000 1.000 0.010 

0600350000 6 Soybean, oil 0.003000 1.000 0.010 

0600350001 6 Soybean, oil-babyfood 0.003000 1.000 0.010 

1001369000 10A Tangerine 0.003000 1.000 0.100 

1001370000 10A Tangerine, juice 0.003000 1.000 0.100 

5000382000 50 Turkey, meat 0.003000 1.000 1.000 

5000382001 50 Turkey, meat-babyfood 0.003000 1.000 1.000 

5000383000 50 Turkey, liver 0.003000 1.000 1.000 

5000383001 50 Turkey, liver-babyfood 0.003000 1.000 1.000 

5000384000 50 Turkey, meat byproducts 0.003000 1.000 1.000 

5000384001 50 Turkey, meat byproducts-babyfood 0.003000 1.000 1.000 

5000385000 50 Turkey, fat 0.003000 1.000 1.000 

5000385001 50 Turkey, fat-babyfood 0.003000 1.000 1.000 

5000386000 50 Turkey, skin 0.003000 1.000 1.000 

5000386001 50 Turkey, skin-babyfood 0.003000 1.000 1.000 

0502389000 5B Turnip, greens 0.003000 1.000 1.000 

1400391000 14 Walnut 0.003000 1.000 0.025 

1500401000 15 Wheat, grain 0.003000 1.000 0.010 

1500401001 15 Wheat, grain-babyfood 0.003000 1.000 0.010 
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

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1500402000 15 Wheat, flour 0.003000 1.000 0.010 

1500402001 15 Wheat, flour-babyfood 0.003000 1.000 0.010 

1500403000 15 Wheat, germ 0.003000 1.000 0.010 

1500404000 15 Wheat, bran 0.003000 1.000 0.010 

Attachment 5 Results of Cancer DEEM-FCID Dietary Exposure Analysis for CPU

US EPA Ver. 3.16, 03-08-d

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

Residue file name: C:\Users\sbiswas\Desktop\DEEM file\CPU Cancer Milk And Water.R08

 Adjustment factor #2 used.

Analysis Date 07-20-2015/09:50:23 Residue file dated: 07-16-2015/15:08:36

Q* = 0.0152 

COMMENT 1: CPU Q*

===============================================================================

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Lifetime risk

 Subgroup body wt/day (Q*= .0152)

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

Total US Population 0.000187 2.84E-06

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

Attachment 6 Results of Cancer DEEM-FCID Dietary Exposure Analysis for PCA

US EPA Ver. 3.16, 03-08-d

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

Residue file name: C:\Users\sbiswas\Desktop\DEEM file\PCA Cancer Food half loq with PDP 

fish_newpercent CT 7-30-2015.R08

 Adjustment factor #2 used.

Analysis Date 07-30-2015/18:43:30 Residue file dated: 07-30-2015/18:32:39

Q* = 0.112 

COMMENT 1: PCA Q*

===============================================================================

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Lifetime risk

 Subgroup body wt/day (Q*= .112)

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

Total US Population 0.000012 1.31E-06
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

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Attachment 7 Screening Level Estimates of Agricultural Uses of Diflubenzuron (108201)

Sorted Alphabetically, March 12, 2015; Reporting Years: 2004-2013.

Annual Average Percent Crop Treated

Crop Lbs. A.I. Average Maximum

1 Alfalfa <500 <1 <2.5

2 Almonds 20,000 10 25

3 Apricots <500 10 30

4 Artichokes 4,000 45 80

5 Cherries <500 <2.5 <2.5

6 Cotton 1,000 <1 <2.5

7 Grapefruit 6,000 25 45

8 Lemons <500 <1 <2.5

19 Nectarines* 1,000 NC NC

10 Oranges 30,000 10 20

11 Peaches 1,000 5 10

12 Peanuts 10,000 10 15

13 Pears 1,000 5 10

14 Pecans 2,000 <2.5 5

15 Peppers <500 <2.5 5

16 Pistachios* <500 NC NC

17 Plums/Prunes 1,000 5 10

18 Rice 2,000 <2.5 <2.5

19 Soybeans 7,000 <1 <2.5

20 Tangelos <500 10 20

21 Tangerines 2,000 10 10

22 Walnuts 2,000 <2.5 5

23 Wheat <500 <1 <2.5

All numbers are rounded.

<500: less than 500 pounds of active ingredients.

 <2.5: less than 2.5 percent of crop is treated.

<1: less than 1 percent of crop is treated. 

* Based on CA DPR data only (80% or more of U.S. acres grown are in California)

NC: not calculated, only pounds a.i. available. 

SLUA data sources include: 

USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service) 

Private Pesticide Market Research

These results reflect amalgamated data developed by the Agency and are releasable to the public.
Diflubenzuron (PC Code 108201) Dietary Exposure and Risk Assessment DP #: 427147

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