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

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON

, D

. C

. 20460



### Office of Chemica l Safety a n d Polluti on Pr eve ntion



### Dat e : 8 / 5/2015

SUBJECT: Diflubenzuron. Chronic Non-Cancer and Ca ncer Dietary a n d D rinkin g Water Exposure a nd Risk Assessments in S up port of the New Use R eg i strat i on of

Diflub enzuron f'onnulated Product on Alfalfa

, Carrot, Cottonseeds Subgroup

20C

, Pe ac h Subgroup 12-128

, Plum Subgroup I 2-I 2C Pepp ers / Eggplant Subgroup 8-1 OB and Conver s ion for Tree Nuts Group 1 4-12.

PC Co d e: I 0820 I



### D ec i sio n No.: 4941 16



### Pet i t i o n No.: 4E8306 

### DP Barcod e: 427147



### Re g i s tration No.: 400-46 1



### Re g ulatory Actio n : 

### Section 3

C a se No.: 0144 

### Ri s k Assess m e nt Ty p e: 

### Dietary

TXR No.: 

### NA CAS No: 35367-38-5



### MRID No.: 

### NA 40 

### CFR: 180.377



### Re v ie,v e r:

Through:



### TO: Sumitra Bo se B i swas, Chemist

# ~~ 

# rJ ·**~** 

# ·

Risk Assessment Branch VI

Health Effects Division ( RABVI / H E D ; 7509P)

Tom Bloem

, Chemist, Designated

# Revie**~1$.~** Thurston Morton

, Chemist, Designated Reviewer 

# < 

# J

Dietary Exposure Science Advisory Council (DESAC f"

A nd

Donna S. Dav i s, Acting Chief

Risk Assessmen t Branch 4

, H ealth Effects Di v ision ( 7509P )

Andrew Ertman/Barbara Madden

Ri s k Int egra ti o n
, Minor Use & 

### Eme r gency R espo n se B ranch Registration Division 

### (RD) (7505 P )

Page I of 22Diflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 2 of 22 Executive Summary

T he 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 Subgr oup 12

- 12B, Plum S ubgroup 12

- 12 C Peppers/Eggplant Subgroup 8

- 10B and Tree Nuts Group 14

- 12. The c hronic non

- cancer and

cancer dietary risk assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEM

- FCIDTM ) , Ve rsion 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 Procedure s (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 diflubenzu ron 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 HE D '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 c lassified 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 expo sure 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 estim ate 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 C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 3 of 22 I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the r isk 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 r isk 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 met abolism studies. The metabolism of diflubenzuron in crops tested is similar, and the radioactive components are also similar to those found in soil.

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

and rumin ant 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 meta bolites 4

- chlorophenylurea (CPU) and 4

- chloroaniline (PCA)

. EFED has determined that PCA i s 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 a ssessment for PCA.

Parent diflu benzuron and matabolite CPU are included in the chronic non

- cancer riskDiflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 4 of 22 assessment . I ndividual cancer risk assessment s 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 pp m 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. 3 77(a)(2) are expressed in terms of the combined residues of

diflubenzuron and its met abolites 4

- chlorophenylurea (CPU) and 4

- chloroaniline (PCA)

. Under this section, current tolerances range from 0.0 2 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

r esidues 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 require d 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 A ssessment : Based on the toxicity profile

, t he c hronic non

- cancer exposure analys e s 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 s ome 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 CP U, was used for the CPU

chronic cancer assessment for m ilk commodities. D iflubenzuron 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 st ill unlikely to be found in milk and therefore current use of 0.003 ppm for milk continues to be justified. R esidues of CPU in the remaining

commod ities is considered negligible.Diflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 5 of 22 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 tolerance s 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 re placed 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. 1 0 Poultry, fat Current tolerance level is 0.05 ppm; Increase to support the diflubenzu ron

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, roo ts

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

Est ablished 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.Diflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 6 of 22 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 replac ed 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 no n

- cancer dietary exposure analys i s used 100% crop treated while the cancer dietary exposure analysis used the following average percent crop tr eated: 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 provid ed 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 /2 0 /20 15 ) and incorporated directly i nto 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 we ll as 0.25 lbs a.i./A X 4 applicati ons/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 recomm ended 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 ofDiflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 7 of 22 diflubenzuron for citrus use. For CPU, the reco mmended 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

a e rial application representative of citrus use

.

For groundwater sources of drinking water, the maximum acute and chronic estimated concentrations of CPU in shallow gro undwater 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 T able 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 water 1 Diflubenzur

on 2 4.61 0.41 0.38

CPU 2 6.83 0.89 0.51

Total 11.44 1.3 0.89



### Groundwater 1 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 cit rus use

2 Estimated in FL Citrus scenario



### V. DEEM

- FCID Program and Consumption Information

A diflubenzuron chronic dietary exposure assessment w as 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 c onsumption 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 asses sment are retained as individual consumption events. Based on analysis of theDiflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 8 of 22 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

pop ulation 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 food

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate f or 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 ev aluated 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, Ca ncer 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

f ound in water, with potential toxicity concerns.

Therefore, a ca ncer assessment for CPU milk and water was conducted using a Q* of 1.52 x 10

- 2



### . In addition, a c ancer 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.Diflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 9 of 22 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 s ulfhemoglobinemia

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 non

carcinogenicity for hum ans.

Cancer (oral, dermal,
inhalation) PCA “Group B2"
probably human
carcinogen
Q 1 * 1.12 x 10

- 1

(mg/kg/day)

- 1 Not Applicable NTP Oral mouse study

Cancer (oral, dermal,
inhalation) CPU Q 1 * based on

monuron a structural
analog and the Q 1 * 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 =

ma rgin 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 C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 10 of 22 females 13

- 49, a dults 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 dos e and endpoint were not identified for this risk

assessment. D iflubenzuron 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 p erformed.

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, chi ldren

1

- 2 years old, was 3 8 % 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

Ex posure (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. 00 2 05 6 10

Diflubenzuron is classified as “Group E,”

evidence of non

carcinogenicity for humans, therefore, a dietary cancer assessment is not required. All Infants (< 1 year old) 0.00 2 6 6 7 1 3

Children 1

- 2 years old 0.007 726 3 9

Children 3

- 5 years old 0.00 5 705 2 9

Children 6

- 12 years old 0.00 297 7 1 5

Youth 13

- 19 years old 0.00 1 709 9

Adults 20

- 49 years old 0.001 509 8

Adults 50

- 99 years old 0.00 15 84 8

Female s 13

- 49 years old 0.00 14 97 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 estim at e 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



### .Diflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 11 of 22 Table 5 . Summary of Dietary ( Milk and Drinking Water) 

### Exposure and Risk for Metabolite CPU

Population Subgroup Acute Dietary ( 95 Perce ntile) 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 0.000 187 2.8 x 10

- 6



### Table 6 . Summary of Dietary (Food Only) Exposure and Risk for M etabolite 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 0.00001 1 1.3 x 10

- 6



### VIII. Characterization of Inputs/Outputs

Th e 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 commoditie s. 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 chroni c 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 analys e s w ere 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 po pulation 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 d ietary exposure estimate for the U.S. population is 2.8 x 10

- 6



### .Diflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 12 of 22 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 D EEM

- 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 DiflubenzuronDiflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 13 of 22 Attachment 1 Chronic DEEM

- FCID R esidue 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 Almon d, 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

- babyfoo d 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

310004900 1 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 But ternut 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

- babyfo od 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

9500113 000 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 C ollards 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 1.000Diflubenzuron ( PC C ode 1 082 01 ) 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)

- b abyfood 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 0.0180 00 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 1.00 0 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

05021 94000 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 fo rmu 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 0.05 0000 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 1.0 00 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

150 0233001 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 10 A 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

- b abyfood 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

0 802272001 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 1.000Diflubenzuron ( PC C ode 1 082 01 ) 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, dr ied

- 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

050231800 0 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 Ric e, 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

- b abyfood 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

5000382 000 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 T urkey, 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 0.0600 00 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 1.000Diflubenzuron ( PC C ode 1 082 01 ) 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

Referen ce 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 Percen t 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 8 86 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 0.00772 6 259 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

Re sidue 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/i nfant 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 1.000Diflubenzuron ( PC C ode 1 082 01 ) 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 \ D esktop \ 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

Comme nt: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 Broc coli 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 1.000Diflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 18 of 22 95001120 00 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 Co conut, 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 0.01800 0 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

330018 9000 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, pee l 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 0.003 000 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 1.00 0 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 0.1 00 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

1202 260001 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 0.0 03000 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 0.025Diflubenzuron ( PC C ode 1 082 01 ) 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

12 03286000 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 1 2C 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 bypro ducts 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 Shee p, 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

50003850 00 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 Tu rkey, 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 0.010Diflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 20 of 22 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 Di etary 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 P CA

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 PD P 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

- 06Diflubenzuron ( PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 21 of 22 Attachment 7 Screening Level Estimates of Agricultural Uses of Diflubenzuron (108201)

Sorted Alphabetically

, March 12, 2015 ; Reporting Years: 200 4

- 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:

US DA

- 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 C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 427147



### Page 22 of 22