Diflubenzuron (PC Code I 0820 I) Dietary Exposure and Risk Assessment DP # : 407784

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### Office of Cbemical Safety and Pollution Prevention



### MEMORANDUM

December 12, 20 1 3

SUBJECT: Diflubenzuron C hronic Non

- Cance r and Cancer Dietary and Drinking Water Expos ure and Risk Assessments for th e Amended Use on the Citrus C rop Group.

PC Code: 108201 DP Barcode: 407784

Decision No.: 465093 Registration No.: 400-461, 400-466, 400-487

Petition No.: 2F80 15 Regulatory Action: Sec tion 3

Risk Assessment Type: Dietary Case No.: 0144

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

MRID No.: NA**4~CFR:** 

### 80.377



### Reviewer: Thurston G. Morton, Chemist

# -:Y{~·**·** Risk Assessment Branch IV/Hea l t Effe

. cts Division (RABIV/HED; 7509P)

Through: Sheila Piper, C h emist Seyed Tadayon, C hemi st Dietary Exposure Science 

# ¥----

TO: visory Council (DESAC)

And

# ~ Susan V. Hummel, Senior Chemist

RABIV/HED (7509P)

Rita Kumar

Insecticide/Rodenticide Branch!RD (7505P)

This document provides a chronic non-cancer and cancer dietary and drinking water risk analysis

of exposures resulting from use of diflubenzuron. This assessment sup port s a Section 3 request

to add the remaining c r ops for a Citrus Crop Group Tolerance.

Page 1 of22Diflubenzuron (PC Code I 0820 I) Dietary Exposure and Risk Assessment DP # : 407784



### 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 the

citrus crop group. The chronic non-cancer and cancer dietary risk assessment was conducted using the Dietary Exposure Evalua tion Model software with th e Food Commodity Intake

Database (DEEM-FCIDTM)

, Version 3.16

, which i ncorporates consumption data from U SDA ' 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) 20 12.1.



### Acute Dietary Exposure Results and Characteri z ation

N o toxic effects attributab l e t o a sing l e (i.e., acute) exposure t o diflubenzuron have been
identified; therefore

, an acute reference dose (RID) has not been estab li shed for diflubenzuron

and an acute dietary exposure assessment has not been conducted.



### Chronic Dietary Exposure Results and Characterization

The s lightly refined chron i c dietary risk assessment for diflubenzuron shows that chronic dietary

risk estimates do not exceed HED's le vel of concern (i.e. <1 00% chronic popu l ation 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 l evel 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 o ld

, i s 38% of the cPAD. The

genera l US population utilizes 11% of the cP AD.



### Cancer

Diflubenzuron is clas s ified as "Group E," evidence of non-carcinogenicity for humans, therefore

,

a dietary cancer a s ses s ment is not required. However

, metabo li tes CPU and PCA are considered probable carcinogens and have Q*s assigned to them. Indi v idu al cancer dietary exposure analyses were conducted for each metabolit e.

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

, the

cancer dietary exposure est imate for the U.S. population is 1 x 10-6. The cance r assessment for

CPU includes milk and water only. For CPU

, the cancer dietary exposure es timate for the U.S. population is 3 X 

### 1 0" 6

.



### Page 2 of22Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 3 of 22 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 po pulation 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 10 0% 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).

Diflubenzuron had a previous dietary risk assessment conducted ( B. Hanson , D 337826

, 4 /1 6 / 07 ).

II. Residue Information

Diflubenzuron Use :

In this analysis the chronic dietary exposure and risk estimates resulting from food intake were determined for the general U.S. population and various population subgroups resulting from the

addition of remaining crop commodities in the citrus crop group to the existing food uses for

diflubenzuron.

Diflubenzuron ( N

- [((4

- chlorophenyl)amino)carbonyl]

- 2,6

- difluorobenzimide), a member of the

urea

- derivative chemical family, is an insecticide/acaricide (insec t 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

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.

T he nature of the resi due 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, for the purpose of

toleran ce expression, are diflubenzuron and its metabolites 4

- chlorophenylurea (CPU) and 4

- chloroaniline (PCA).Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 4 of 22 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 byproducts to 6.0 ppm in globe artichoke.

Tolerances listed in 40 CF R §180. 3 77(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 0.0 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 residues of diflubenzuron and its metabolites CPU and PCA, expressed as the parent diflubenzuron, in connection with use of the pesticide under Section 18 Emergenc y Exemptions granted by EPA. Under this section, current tolerances range from 0. 10 ppm in/on wheat milled byproducts to 30 ppm in/on wheat aspirated grain fractions

.

Residue Data Used for Chronic Assessments

The current dietary exposure analys e s assume d that diflubenzuron residues were present in all

commodities at established/recommended tolerance levels for most commodities except orange (0.367 ppm), grapefruit (0.214 ppm) and lemon (0.653 ppm) which used average field trial

residues. The chronic die tary exposure analysis assumed 100% of all proposed and existing crops were treated , and that DEEM TM 

### Version 7.81 default processing factors were used for some processed commodities. A processing factor of 0.1x was used for citrus juices.

As part of the current petition, HED recommends establishing a crop group tolerance listed in

Table 1 for residues of diflubenzuron.

Table 1. Proposed/Recommended Tolerances for Diflubenzuron

Commodity Recommended Tolerance

Citrus fruit 10

- 10 3.0 ppm



### Also , due t o the nature of the plant, residential plantings of avocados are too prolific for stripping. A residue value of 0.8 ppm will be applied in this assessment for avocados for those potential residues.

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

in DEEM . This represents 1⁄2 the LOQ. An average residue of 0.048 ppm was used for mushroom residue input value in the PCA cancer assessment. A residue value of 0.003 ppm was

used for the CPU cancer assessment for mi lk commodities.Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 5 of 22 III. Percent Crop Treated Information

The chronic non

- cancer dietary exposure analys i s used 100% crop treated while the cancer dietary exposure analysis used the following average percent crop treated: soybeans (1%), peppers (1%), orange s (5%), tangerines (5%), grapefruit (15%), pear (5%), apricot (10%), peach (5%), almond, (10%), pecan (2.5%), rice (1%), wheat (1%), cotton (1%), artichoke (50%), and peanut (5%)

.

IV. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division, summarized in the following memorandum:

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

Diflubenzuron. ” (DP #: 400093

, F

. Khan and S. Wente

, 11 / 2 0 /20 12 ) and incorporated directly into this dietary assessment. Water residues were incorporated in the DEEM

- FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

The estimated drinking water concentrations (E DWCs) for diflubenzuron use on citrus are higher than the previously recommended annual mean (chronic/non cancer) and 30 year average (chronic/cancer) concentrations for surface water. Therefore, the currently calculated EDWCs ( 3.47 μg /L for the peak (acute) concentration, 0.26 μg /L for the annual mean (chronic/non cancer) concentration, and 0.12 μg /L for the 30 year average concentration (chronic/cancer) are

recommended for diflubenzuron.

The current EDWCs of 4

- chlorophenyl ure a (CPU) for surface water do not supersede the drinking water concentrations previously estimated ( US EPA, 2002: D279732 ) for drinking water. Therefore, the values ( 20.68 μg/L for the peak (acute) concentration, 12.52 μg /L for the annual mean (chronic/non

- cancer) concentration, and 8. 81 μg /L for the 36 year average concentration (chronic/cancer) from the previous drinking water assessment are recommended.

Since requested label modifications have no implication in groundwater modeling, groundwater expos ure for drinking water was not performed. Th e previous SCI

- GROW model estimated the concentrations of parent diflubenzuron and the degradate CPU in drinking water from shallow ground water sources to be 0.006 μg /L and 0.201 μg /L , respectively (US EPA,

20 02). The above concentrations can be considered as both the acute and chronic value for the respective chemicals.Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 6 of 22 Summary of Estimated Surface Water and Groundwater Concentrations for Diflubenzuron

.
Scenario Surface Water Conc., pp b a Groundwater Conc., ppb b

Acute 24.2 0.207

Chronic (non

- cancer) 12.8 (parent 12.52 ppb+ CPU 0.26 ppb summed) 0.207

Chronic (cancer) 8.81 CPU

a From the Tier II PRZM

- EXAMS

- Index Reservoir model.

b From the SCI

- GROW model.



### V. DEEM

- FCID Program and Consumptio n 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 consumption of more than 20,000 individuals over two non

- consecutive survey days. F oods “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 U SDA/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

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 food

form (e.g., orange or orange juice) on the food commodi ty 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 f

ood/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 Inf

ormation

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.

The following is excerpted from the HED Metabolism Committee Meeting Memorandum of 5/31/01 (D272976).Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 7 of 22 “ 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 informatio n was found (Personal Communication, Alberto Protzel, 5/8/01), risk from CPU will be assessed as follows: 1) for carcinogenic effects, a Q1* will be calculated for monuron and applied to CPU;

EFED has determined that PCA is only a minor metabolite of DFB in the environment (K. Costello, Personal Communication, 2/28/01). Drinking water will thus not be considered in the risk assessment for PCA. 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 ca ncer assessment for CPU milk an d 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



### .Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 8 of 22 Exposure

Scenario Dose Used in Risk

Assessment, UF FQPA SF and LOC

for Risk Assessment
Study and Toxicological Effects

Acute Die tary 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

Chron ic 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 non

carcinogenicity for humans.

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 safe ty 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)Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 9 of 22 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 populatio n subgroups. The results reported in Table 3 are for the general U.S. Population, all infants (<1 year old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19,

females 13

- 49, adults 20

- 49, and adults 50

- 99 years. The results reported in Tables 4 and 5 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. D iflubenzuro n 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

Th e 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 3 8 % of the cPAD.

Table 3 . Summary of Dietary (F ood 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

co nducted. 0. 00 2139 11

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 2 615 1 3

Children 1

- 2 years old 0.007 606 3 8

Children 3

- 5 years old 0.00 5 678 2 8

Children 6

- 12 years old 0.00 3006 1 5

Youth 13

- 19 years old 0.00 1 800 9.0

Adults 20

- 49 years old 0.001 634 8.2

Adults 50

- 99 years old 0.001 667 8 .3

Females 13

- 49 years old 0.001 615 8.1

*The values for the highest expose d population for each type of risk assessment should be boldedDifluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 10 of 22 Results of the Chronic Cancer Dietary Exposure Analysis

For PCA, the cancer dietary exposure estimate for the U.S. population is 1 x 10 - 6 

### . For CPU, the cancer dietary exposure estimate for t he U.S. population is 3 x 10 - 6



### .

Table 4. 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 0.000 204 3 x 10 - 6



### Table 5. 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 0.000010 1 x 10 - 6



### VIII. Characterization of Inputs/Outputs

Th e chronic non

- cancer analysis is slightly refined d ietary 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 resid ues, 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 t he 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.Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 11 of 22 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 population subgroups are below HED’s level of concern. 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 x 10 - 6 

### . For CPU, the cancer dietary exposure estimate for the U.S. population is 3 x 10 - 6



### .

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 AnalysisDifluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 12 of 22 Attachment 1 Chronic DEEM

- FCID Residue Input File

Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 108201

Diflubenzuron \ Citrus 2F8015 \ CHRONIC.R08

Chemical: Diflubenzuron RfD(Chronic): .02 mg/kg bw/day NOEL(Chronic): 2 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 09

- 18

- 2013/14:24:40 Program ver. 3.16, 03

- 08

- d Comment: Section 18 request for use on wheat and barley . Chronic only. cRfD = cPAD.

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 0502063000 5B Broccoli raab 9.000000 1.000 1.000 0502070000 5B Cabbage, Chinese, bok choy 9.000000 1.000 1.000

0502117000 5B Collards 9.000000 1.000 1.000

0502194000 5B Kale 9.000000 1.000 1.000 0502229000 5B Mustard greens 9.000000 1.000 1.000 0502318000 5B Rape gree ns 9.000000 1.000 1.000 0502389000 5B Turnip, greens 9.000000 1.000 1.000 0600347000 6 Soybean, seed 0.050000 1.000 1.000 6F1832 0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 6F1832 0600349001 6 Soybean, soy milk

- babyfood or in 0.050000 1.000 1.000 6F1832 0600350000 6 Soybean, oil 0.050000 1.000 1.000 6F1832 0600350001 6 Soybean, oil

- babyfood 0.050000 1.000 1.000 6F1832 0603348000 6C Soybean, flour 0.050000 1.000 1.000 6F1832 0603348001 6C Soybean, flour

- babyfood 0.050000 1.000 1.000 6F1832 0802270000 8B Pepper, bell 1.00000 0 1.000 1.000 1F0623

Full comment: 1F06235 0802270001 8B Pepper, bell

- babyfood 1.000000 1.000 1.000 1F0623

Full comment: 1F06235 0802271000 8B Pepper, bell, dried 1.000000 1.000 1.000 1F06 23

Full comment: 1F06235 0802271001 8B Pepper, bell, dried

- babyfood 1.000000 1.000 1.000 1F0623

Full comment: 1F06235 0802272000 8BC Pepper, nonbell 1.000000 1.000 1.000 1F0623

Full co mment: 1F06235 0802272001 8BC Pepper, nonbell

- babyfood 1.000000 1.000 1.000 1F0623

Full comment: 1F06235 0802273000 8BC Pepper, nonbell, dried 1.000000 1.000 1.000 1F0623

Full comment: 1F06235

1001106 000 10A Citron 3.000000 1.000 1.000 2F8015 1001107000 10A Citrus hybrids 3.000000 1.000 1.000 2F8015 1001108000 10A Citrus, oil 60.000000 1.000 1.000 2F8015

1001240000 10A Orange 0.367000 1.000 1.000 2F8015 1001241000 10A Orange, juice 0.367000 1.800 1.000 2F8015 1001241001 10A Orange, juice

- babyfood 0.367000 1.800 1.000 2F8015 1001242000 10A Orang e, peel 0.367000 1.000 1.000 2F8015 1001369000 10A Tangerine 3.000000 1.000 1.000 2F8015 1001370000 10A Tangerine, juice 3.000000 2.300 1.000 2F8015 1002197000 10B Kumquat 3.000000 1.000 1.000 2F8015

1002199000 10B Lemon 0.653000 1.000 1.000 2F8015 1002200000 10B Lemon, juice 0.653000 2.000 1.000 2F8015 1002200001 10B Lemon, juice

- babyfo od 0.653000 2.000 1.000 2F8015 1002201000 10B Lemon, peel 0.653000 1.000 1.000 2F8015

1002206000 10B Lime 3.000000 1.000 1.000 2F8015 1002207000 10B Lime, juice 3.000000 1.000 1.000 2F8015 1002207001 10B Lime, juice

- babyfood 3.000000 1.000 1.000 2F8015 1003180000 10C Grapefruit 0.214000 1.000 1.000 2F8015 1003181000 10C Grapefruit, juice 0.214000 2.100 1.000 2F8015

1003307000 10C Pummelo 3.000000 1.000 1.000 2F8015

1100266000 11 Pear 0.500000 1.000 1.000 99OR00

Full comment: 99OR0009

1100266001 11 Pear

- babyfood 0.500000 1.000 1.000 99OR00

Full comment: 99OR0009 1100267000 11 Pear, dried 0.500000 6.250 1.000 99OR00

Full comment: 99OR0009 1100268000 11 Pear, juice 0.500000 1.000 1.000 99OR00

Full comment: 99OR0009 1100268001 11 Pear, juice

- babyfood 0.500000 1.000 1.000 99OR00

Full comment: 99OR0009Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 13 of 22 1202012000 12B Apricot 0.070000 1.000 1.000 1F0623

Full comment: 1F06235 1202012001 12B Apricot

- babyfood 0.070000 1.000 1.000 1F0623

Full comment: 1F06235 1202013000 12B Apricot, dried 0.070000 6.000 1.000 1F0623

Full comment: 1F06235 1202014000 12B Apricot, juice 0.070000 1.000 1.000 1F0623

Full comment: 1F06235 1202014001 12B Apricot, juice

- babyfood 0.070000 1.000 1.000 1F0623

Full comme nt: 1F06235

1202230000 12B Nectarine 0.070000 1.000 1.000 1F0623

Full comment: 1F06235

1202260000 12B Peach 0.070000 1.000 1.000 1F0623

Full comment: 1F06235

1202260001 12B Peach

- babyfood 0.070000 1.000 1.000 1F0623

Full comment: 1F06235 1202261000 12B Peach, dried 0.070000 7.000 1.000 1F0623

Full comment: 1F06235 1202261001 12B Peach, dried

- bab yfood 0.070000 7.000 1.000 1F0623

Full comment: 1F06235 1202262000 12B Peach, juice 0.070000 1.000 1.000 1F0623

Full comment: 1F06235 1202262001 12B Peach, juice

- babyfood 0.0 70000 1.000 1.000 1F0623

Full comment: 1F06235

1203285000 12C Plum 0.070000 1.000 1.000 1F0623

Full comment: 1F06235

1203285001 12C Plum

- babyfood 0.070000 1.000 1.000 1F0623

Full comment: 1F06235 1203286000 12C Plum, prune, fresh 0.070000 1.000 1.000 1F0623

Full comment: 1F06235 1203286001 12C Plum, prune, fresh

- babyfood 0.070000 1.000 1.000 1F0623

Ful l comment: 1F06235 1203287000 12C Plum, prune, dried 0.070000 5.000 1.000 1F0623

Full comment: 1F06235 1203287001 12C Plum, prune, dried

- babyfood 0.070000 5.000 1.000 1F0623

Full comment: 1F06235

120 3288000 12C Plum, prune, juice 0.070000 1.400 1.000 1F0623

Full comment: 1F06235 1203288001 12C Plum, prune, juice

- babyfood 0.070000 1.400 1.000 1F0623

Full comment: 1F06235

1400003000 14 Almond 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400003001 14 Almond

- babyfood 0.060000 1.000 1.000 0F0623

Full comment: 0F06235 1400004000 14 Almond, oil 0.060000 1.000 1.000 0F0623

Full comment: 0F06235 1400004001 14 Almond, oil

- babyfood 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400059000 14 Brazil nut 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400068000 14 Butternut 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400081000 14 Cashew 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400092000 14 Chestnut 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400155000 14 Hazelnut 0.060000 1.000 1.000 0F0623

Full comment: 0F06 235 1400156000 14 Hazelnut, oil 0.060000 1.000 1.000 0F0623

Full comment: 0F06235 1400185000 14 Hickory nut 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400213000 14 Ma cadamia nut 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400269000 14 Pecan 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400278000 14 Pine nut 0.060000 1.000 1.000

1400282000 14 Pistachio 0.060000 1.000 1.000 0F0623

Full comment: 0F06235

1400391000 14 Walnut 0.060000 1.000 1.000 8E3582

1500025000 15 Bar ley, pearled barley 0.060000 1.000 1.000Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 14 of 22 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 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

1500323000 15 R ice, 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 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 2003128000 20C Cottonseed, oil 0.200000 1.000 1.000 7F1898 2003128001 20C Cottonseed, oil

- babyfood 0.200000 1.000 1.000 7F1898

2100228000 21 Mushroom 0. 200000 1.000 1.000 2E2731 3100044000 31 Beef, meat 0.050000 1.000 1.000 7F1898 3100044001 31 Beef, meat

- babyfood 0.050000 1.000 1.000 7F1898 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 7F1898 3100046000 31 Beef, meat byproducts 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3100046001 31 Beef, meat byproducts

- babyfood 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3100047000 31 Beef, fat 0.050000 1.000 1.000 7F1898 3100047001 31 Beef, fat

- babyfood 0.050000 1.000 1.000 7F1898 3100048000 31 Beef, kidney 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3100049000 31 Beef, liver 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3100049001 31 Beef, liver

- babyfood 0.150000 1.000 1.000 1F0623

Full comment: 1F 06235 3200169000 32 Goat, meat 0.050000 1.000 1.000 7F1898 3200170000 32 Goat, meat byproducts 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3200171000 32 Goat, fat 0.050000 1.000 1.000 7F1898 3200172000 32 Goat, kidney 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3200173000 32 Goat, liver 0.150000 1.000 1.000 1F0623

Full commen t: 1F06235 3300189000 33 Horse, meat 0.050000 1.000 1.000 7F1898 3400290000 34 Pork, meat 0.050000 1.000 1.000 7F1898 3400290001 34 Pork, meat

- babyfood 0.050000 1.000 1.000 7F1 898 3400291000 34 Pork, skin 0.050000 1.000 1.000 7F1898 3400292000 34 Pork, meat byproducts 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3400292001 34 Pork, meat byproducts

- babyfood 0 .150000 1.000 1.000 1F0623

Full comment: 1F06235 3400293000 34 Pork, fat 0.050000 1.000 1.000 7F1898 3400293001 34 Pork, fat

- babyfood 0.050000 1.000 1.000 7F1898 3400294000 34 Pork, kid ney 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3400295000 34 Pork, liver 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3500339000 35 Sheep, meat 0.050000 1.000 1.000 7F1898 3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 7F1898 3500340000 35 Sheep, meat byproducts 0.150000 1.000 1.000 1F0623

Full comment: 1F06235

3500341000 35 Shee p, fat 0.050000 1.000 1.000 7F1898 3500341001 35 Sheep, fat

- babyfood 0.050000 1.000 1.000 7F1898 3500342000 35 Sheep, kidney 0.150000 1.000 1.000 1F0623

Full comment: 1 F06235Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 15 of 22 3500343000 35 Sheep, liver 0.150000 1.000 1.000 1F0623

Full comment: 1F06235 3600222000 36 Milk, fat 0.050000 1.000 1.000 7F1898 3600222001 36 Milk, fat

- baby food/infant formu 0.050000 1.000 1.000 7F1898 3600223000 36 Milk, nonfat solids 0.050000 1.000 1.000 7F1898 3600223001 36 Milk, nonfat solids

- baby food/in 0.050000 1.000 1.000 7F1898 3600224000 36 Milk, water 0.050 000 1.000 1.000 7F1898 3600224001 36 Milk, water

- babyfood/infant form 0.050000 1.000 1.000 7F1898 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.050000 1.000 1.000 7F1898 3800221000 38 Meat, game 0.050000 1 .000 1.000 3900312000 39 Rabbit, meat 0.050000 1.000 1.000 4000093000 40 Chicken, meat 0.050000 1.000 1.000 7F1898 4000093001 40 Chicken, meat

- babyfood 0.050000 1.000 1.000 7F1898 4000094000 40 Chicken, liver 0.050000 1.000 1.000 7F1898 4000095000 40 Chicken, meat byproducts 0.050000 1.000 1.000 7F1898 4000095001 40 Chicken, meat byproducts

- babyfoo 0.050000 1.000 1.000 7F1898

400009 6000 40 Chicken, fat 0.050000 1.000 1.000 7F1898 4000096001 40 Chicken, fat

- babyfood 0.050000 1.000 1.000 7F1898 4000097000 40 Chicken, skin 0.050000 1.000 1.000 7F1898

4000097001 40 Chicken, skin

- babyfood 0.050000 1.000 1.000 7F1898 5000382000 50 Turkey, meat 0.050000 1.000 1.000 7F1898 5000382001 50 Turkey, meat

- babyfood 0.050000 1.000 1.000 7F1898

5000383000 50 Turk ey, liver 0.050000 1.000 1.000 7F1898 5000383001 50 Turkey, liver

- babyfood 0.050000 1.000 1.000 7F1898 5000384000 50 Turkey, meat byproducts 0.050000 1.000 1.000 7F1898 5000384001 50 Turkey, mea t byproducts

- babyfood 0.050000 1.000 1.000 7F1898 5000385000 50 Turkey, fat 0.050000 1.000 1.000 7F1898 5000385001 50 Turkey, fat

- babyfood 0.050000 1.000 1.000 7F1898 5000386000 50 Turkey, skin 0.050000 1.000 1.000 7F1898 5000386001 50 Turkey, skin

- babyfood 0.050000 1.000 1.000 7F1898 6000301000 60 Poultry, other, meat 0.050000 1.000 1.000 7F1898 6000302000 60 Poultry, other, liver 0.050000 1.000 1.000 7F1898 6000303000 60 Poultry, other, meat byproducts 0.050000 1.000 1.000 7F1898 6000304000 60 Poultry, other, fat 0.050000 1.000 1.000 7F1898 6000305000 60 Poultry, other, skin 0.050000 1.000 1.000 7F1898 7000145000 70 Egg, whole 0.050000 1.000 1.000 7F1898 7000145001 70 Egg, whole

- babyfood 0.050000 1.000 1.000 7F1898 7000146000 70 Egg, white 0.05 0000 1.000 1.000 7F1898 7000146001 70 Egg, white (solids)

- babyfood 0.050000 1.000 1.000 7F1898 7000147000 70 Egg, yolk 0.050000 1.000 1.000 7F1898 7000147001 70 Egg, yolk

- babyfood 0.050000 1.000 1.000 7F1898 8601000000 86A Water, direct, all sources 0.012800 1.000 1.000 8602000000 86B Water, indirect, all sources 0.012800 1.000 1.000 9500016000 O Artichoke, globe 6.000000 1.000 1.000 0E383 5

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 1.000Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 16 of 22 Attachment 2 Resu lts of Chronic DEEM

- FCID Dietary Exposure Analysis

U.S. EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for DIFLUBENZURON NHANES 2003

- 2008 2

- day

Residue file name: C: \ Documents and Se ttings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 108201

Diflubenzuron \ Citrus 2F8015 \ CHRONIC.R08 Adjustment factor #2 used. Analysis Date 09

- 19

- 2013/07:43:53 Residue file dated: 09

- 19

- 2013/07:42:46

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

=============================================================================== Total exposure by population subgroup

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

Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- ---------------- Total US Population 0.002139 10.7% Hispanic 0.002629 13.1%

Non

- Hisp

- White 0.001891 9.5%

Non

- Hisp

- Black 0.002829 14.1%

Non

- Hisp

- Other 0.002534 12.7% Nursing Infant s 0.001233 6.2%

Non

- Nursing Infants 0.003232 16.2%

Female 13+ PREG 0.002396 12.0%

Children 1

- 6 0.00 6149 30.7%

Children 7

- 12 0.002761 13.8%

Male 13

- 19 0.001971 9.9%

Female 13

- 19/NP 0.001637 8.2%

Male 20+ 0.001651 8.3% Female 20+/NP 0.001618 8.1%

Seniors 55+ 0.001633 8.2%

All Infants 0.002615 13.1%

Female 13

- 50 0.001628 8.1%

Children 1

- 2 0.007606 38.0%

Children 3

- 5 0.005678 28.4%

Ch ildren 6

- 12 0.003006 15.0%

Youth 13

- 19 0.001800 9.0%

Adults 20

- 49 0.001634 8.2%

Adults 50

- 99 0.001667 8.3%

Female 13

- 49 0.001615 8.1%

-------------------------------------------------------------------------------Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 17 of 22 Attachment 3 Cancer DEEM

- FCID Residue Input File For CPU

Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 108201

Diflubenzuron \ Citrus 2F8015 \ CPU Cancer Milk And Water.R08

Chemical: Diflubenzuron RfD(Chronic): .02 mg/kg bw/day NOEL(Chronic): 2 mg/kg bw/day
RfD(Acute ): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Q*= .0152 Date created/last modified: 09

- 17

- 2013/12:25:46 Program ver. 3.16, 03

- 08

- d
Comment: CPU Q*

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 3600222000 36 Milk, fat 0.003000 1.000 1.000 7F1898 3600222001 36 Milk, fat

- baby food/infant formu 0.003000 1.000 1.000 7F1898 3600223000 36 Milk, nonfat solids 0.003000 1.000 1.000 7F1898 3600223001 36 Milk, nonfat solids

- b aby food/in 0.003000 1.000 1.000 7F1898 3600224000 36 Milk, water 0.003000 1.000 1.000 7F1898 3600224001 36 Milk, water

- babyfood/infant form 0.003000 1.000 1.000 7F1898 3600225001 36 Milk, sugar (lactose)

- baby f ood/ 0.003000 1.000 1.000 7F1898 8601000000 86A Water, direct, all sources 0.008810 1.000 1.000 8602000000 86B Water, indirect, all sources 0.008810 1.000 1.000Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 18 of 22 Attachment 4 Cancer DEEM

- FCID Re sidue Input File For PCA

Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 108201

Diflubenzuron \ Citrus 2F8015 \ PCA Cancer Food half loq 11

- 19.R08

Chemical: Diflubenzuron RfD(Chronic): .02 mg/kg bw/day NOEL(Chronic): 2 mg/kg bw/da y RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Q*= .112 Date created/last modified: 09

- 13

- 2013/19:35:56 Program ver. 3.16, 03

- 08

- d
Comment: PCA Q*

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 0502063000 5B Broc coli raab 0.003000 1.000 1.000 0502070000 5B Cabbage, Chinese, bok choy 0.003000 1.000 1.000

0502117000 5B Collards 0.003000 1.000 1.000

0502194000 5B Kale 0.003000 1.000 1.000 0502229000 5B Mustard greens 0.003000 1.000 1.000 0502318000 5B Rape greens 0.003000 1.000 1.000 0502389000 5B Turnip, greens 0.003000 1.000 1 .000 0600347000 6 Soybean, seed 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 So ybean, oil 0.003000 1.000 0.010 0600350001 6 Soybean, oil

- babyfood 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 0802270000 8B Pepper, bell 0.003000 1.000 0.010 0802270001 8B Pepper, bell

- babyfood 0.003000 1.000 0.010 0802271000 8B Pepper, bell, dried 0.003000 1.000 0.010 0802271001 8B Pepper, bell, dried

- babyfood 0.003000 1.000 0.010 0802272000 8BC Pepper, nonbell 0.003000 1.000 0.010 0802272001 8BC Pepper, nonbell

- babyfood 0.003000 1.000 0.010

0802273000 8BC Pepper, nonbell, dried 0.003000 1.000 0.010

1001106000 10A Citron 0.003000 1.000 1.000 2F8015 1001107000 10A Citrus hybrids 0.003000 1.000 1.000 2F8015 1001108000 10A Citrus, oil 0.003000 1.000 1.000 2F8015 1001240000 10A Orange 0.003000 1.000 0.050 1001241000 10A Orange, juice 0.003000 0.100 0.050 1001241001 10A Orange, juice

- babyfood 0.003000 0.100 0.050 1001242000 10A Orange, peel 0.003000 1.000 0.050 1001369000 10A Tangerine 0.003000 1.000 0.050 1001370000 10A Tangerine, juice 0.003000 0.100 0.05 0 1002197000 10B Kumquat 0.003000 1.000 1.000 2F8015

1002199000 10B Lemon 0.003000 1.000 1.000 1002200000 10B Lemon, juice 0.003000 0.100 1.000

1002200001 10B Lemon, juice

- babyfood 0.003000 0.100 1.000 1002201000 10B Lemon, peel 0.003000 1.000 1.000

1002206000 10B Lime 0.003000 1.000 1.000 2F8015 1002207000 10B Lime, juice 0.003000 0.100 1.000 2F8015 1002207001 10B Lime, juice

- babyfood 0.003000 0.100 1.000 2F8015 1003180000 10C Grapefruit 0.003000 1.000 0.150 1003181000 10C Grapefruit, juice 0.003000 0.100 0.150

1003307000 10C Pummelo 0.003000 1.000 1.000 2F8015

1100266000 11 Pear 0.003000 1.000 0.050

1100266001 11 Pear

- babyfood 0.003000 1.00 0 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

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

1202230000 12B Nectarine 0.003000 1.000 1.000 1F0623

Full comment: 1F06235

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 0.050Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 19 of 22 1202262001 12B Peach, juice

- babyfood 0.003000 1.000 0.050

1203285000 12C Plum 0.003000 1.000 1.000 1F0623

Full comment: 1F06235

1203285001 12C Plum

- babyfood 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 1203286000 12C Plum, prune, fresh 0.003000 1.000 1.000 1F0623

F ull comment: 1F06235 1203286001 12C Plum, prune, fresh

- babyfood 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 1203287000 12C Plum, prune, dried 0.003000 5.000 1.000 1F0623

Full comment: 1F06235

1 203287001 12C Plum, prune, dried

- babyfood 0.003000 5.000 1.000 1F0623

Full comment: 1F06235 1203288000 12C Plum, prune, juice 0.003000 1.400 1.000 1F0623

Full comment: 1F06235 1203288001 12C Plum, p rune, juice

- babyfood 0.003000 1.400 1.000 1F0623

Full comment: 1F06235

1400003000 14 Almond 0.003000 1.000 0.100

1400003001 14 Almond

- babyfood 0.003000 1.000 0.100

14000040 00 14 Almond, oil 0.003000 1.000 0.100 1400004001 14 Almond, oil

- babyfood 0.003000 1.000 0.100

1400059000 14 Brazil nut 0.003000 1.000 1.000 0F0623

Full comment: 0 F06235

1400068000 14 Butternut 0.003000 1.000 1.000 0F0623

Full comment: 0F06235

1400081000 14 Cashew 0.003000 1.000 1.000 0F0623

Full comment: 0F06235

1400092000 14 Chestnut 0.003000 1.000 1.000 0F0623

Full comment: 0F06235

1400155000 14 Hazelnut 0.003000 1.000 1.000 0F0623

Full comment: 0F06235 1400156000 14 Hazelnut, oil 0.003000 1.000 1.000 0F0623

Full comment: 0F06235 1400185000 14 Hickory nut 0.003000 1.000 1.000 0F0623

Full comment: 0F06235

1400213000 14 Macadamia nut 0.003000 1.000 1.000 0F0623

Full comment: 0F06235

1400269000 14 Pecan 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 0F0623

Full comment: 0F06235

1400391000 14 Walnut 0.003000 1.000 1.000 8E3582 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 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 1.00 0 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 1500323000 15 Rice, white 0.003000 1.000 0.010 1500323001 15 Rice, white

- babyfood 0.003000 1.000 0.010 1500324000 15 Rice, brown 0.003000 1.000 0.010 1500324001 15 Rice, brown

- babyfood 0.003000 1.000 0.010 1500325000 15 Rice, flour 0.003000 1.000 0.010 1500325001 15 Rice, flour

- babyfood 0.003000 1.000 0.010 1500326000 15 Rice, bran 0.003000 1.000 0.010 1500326001 15 Rice, bran

- babyfood 0.003000 1.000 0. 010 1500401000 15 Wheat, grain 0.003000 1.000 0.010 1500401001 15 Wheat, grain

- babyfood 0.003000 1.000 0.010 1500402000 15 Wheat, flour 0.003000 1.000 0.010

1500402001 15 Whe at, 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 2003128000 20C Cottonseed, oil 0.003000 1.000 0.010 2003128001 20C Cottonseed, oil

- babyfood 0.003000 1.000 0.010

2100228000 21 Mushroom 0.048000 1.000 1.000 2E2731 3100044000 31 Beef, meat 0.003000 1 .000 1.000 7F1898 3100044001 31 Beef, meat

- babyfood 0.003000 1.000 1.000 7F1898Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 20 of 22 3100045000 31 Beef, meat, dried 0.003000 1.920 1.000 7F1898 3100046000 31 Beef, meat byproducts 0.003000 1.000 1 .000 1F0623

Full comment: 1F06235 3100046001 31 Beef, meat byproducts

- babyfood 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3100047000 31 Beef, fat 0.003000 1.000 1.000 7F1898

310004700 1 31 Beef, fat

- babyfood 0.003000 1.000 1.000 7F1898 3100048000 31 Beef, kidney 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3100049000 31 Beef, liver 0.003000 1.0 00 1.000 1F0623

Full comment: 1F06235 3100049001 31 Beef, liver

- babyfood 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3200169000 32 Goat, meat 0.003000 1.000 1.000 7F1898

3200 170000 32 Goat, meat byproducts 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3200171000 32 Goat, fat 0.003000 1.000 1.000 7F1898 3200172000 32 Goat, kidney 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3200173000 32 Goat, liver 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3300189000 33 Horse, meat 0.003000 1.000 1.000 7F1898 3400290000 34 Pork, meat 0.003000 1.000 1.000 7F1898 3400290001 34 Pork, meat

- babyfood 0.003000 1.000 1.000 7F1898 3400291000 34 Pork, skin 0.003000 1.000 1.000 7F1898

340029 2000 34 Pork, meat byproducts 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3400292001 34 Pork, meat byproducts

- babyfood 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3400293000 34 Pork, fat 0.003000 1.000 1.000 7F1898 3400293001 34 Pork, fat

- babyfood 0.003000 1.000 1.000 7F1898 3400294000 34 Pork, kidney 0.003000 1.000 1.000 1F0623

Full comment: 1F06235

3 400295000 34 Pork, liver 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3500339000 35 Sheep, meat 0.003000 1.000 1.000 7F1898 3500339001 35 Sheep, meat

- babyfood 0.0030 00 1.000 1.000 7F1898 3500340000 35 Sheep, meat byproducts 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3500341000 35 Sheep, fat 0.003000 1.000 1.000 7F1898 3500341001 35 Sheep, fat

- bab yfood 0.003000 1.000 1.000 7F1898 3500342000 35 Sheep, kidney 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3500343000 35 Sheep, liver 0.003000 1.000 1.000 1F0623

Full comment: 1F06235 3800221000 38 Meat, game 0.003000 1.000 1.000 3900312000 39 Rabbit, meat 0.003000 1.000 1.000 4000093000 40 Chicken, meat 0.003000 1.000 1. 000 7F1898 4000093001 40 Chicken, meat

- babyfood 0.003000 1.000 1.000 7F1898 4000094000 40 Chicken, liver 0.003000 1.000 1.000 7F1898 4000095000 40 Chicken, meat byproducts 0.003000 1.000 1.000 7F 1898 4000095001 40 Chicken, meat byproducts

- babyfoo 0.003000 1.000 1.000 7F1898 4000096000 40 Chicken, fat 0.003000 1.000 1.000 7F1898 4000096001 40 Chicken, fat

- babyfood 0.003000 1.000 1.000 7F1898

40 00097000 40 Chicken, skin 0.003000 1.000 1.000 7F1898 4000097001 40 Chicken, skin

- babyfood 0.003000 1.000 1.000 7F1898 5000382000 50 Turkey, meat 0.003000 1.000 1.000 7F1898

500038200 1 50 Turkey, meat

- babyfood 0.003000 1.000 1.000 7F1898 5000383000 50 Turkey, liver 0.003000 1.000 1.000 7F1898 5000383001 50 Turkey, liver

- babyfood 0.003000 1.000 1.000 7F1898

5000384000 50 Turkey, meat byproducts 0.003000 1.000 1.000 7F1898 5000384001 50 Turkey, meat byproducts

- babyfood 0.003000 1.000 1.000 7F1898 5000385000 50 Turkey, fat 0.003000 1.000 1.000 7F1898 5000385001 50 Turkey, fat

- babyfood 0.003000 1.000 1.000 7F1898 5000386000 50 Turkey, skin 0.003000 1.000 1.000 7F1898 5000386001 50 Turkey, skin

- babyfood 0.003000 1.000 1.000 7F1898 6000301000 60 Poultry, other , meat 0.003000 1.000 1.000 7F1898 6000302000 60 Poultry, other, liver 0.003000 1.000 1.000 7F1898 6000303000 60 Poultry, other, meat byproducts 0.003000 1.000 1.000 7F1898 6000304000 60 Poultry, other, fat 0.003000 1.000 1.000 7F1898 6000305000 60 Poultry, other, skin 0.003000 1.000 1.000 7F1898Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 21 of 22 7000145000 70 Egg, whole 0.003000 1.000 1.000 7F1898 7000145001 70 Egg, whole

- babyfood 0.003000 1.000 1.000 7F1898 7000146000 70 Egg, white 0.003000 1.000 1.000 7F1898 7000146001 70 Egg, white (solids)

- babyfood 0.003000 1.000 1.000 7F1898 7000147000 70 Egg, yolk 0.003000 1.000 1.000 7F1898 7000147001 70 Egg, yolk

- babyfood 0.003000 1.000 1.000 7F1898 9500016000 O Artichoke, globe 0.003000 1.000 0.500

9500263000 O Peanut 0.003000 1. 000 0.050 9500264000 O Peanut, butter 0.003000 1.890 0.050 9500265000 O Peanut, oil 0.003000 1.000 0.050Difluben zuron (PC C ode 1 082 01 ) Dietary Exposure and Risk Assessment DP #: 40 7784



### Page 22 of 22 Attachment 5 Results of Can cer DEEM

- FCID Dietary Exposure Analysis for CPU

U.S. EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for DIFLUBENZURON NHANES 2003

- 2008 2

- day

Residue file name: C: \ Documents and Setti ngs \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 108201

Diflubenzuron \ Citrus 2F8015 \ CPU Cancer Milk And Water.R08 Adjustment factor #2 used. Analysis Date 09

- 17

- 2013/12:26:22 Residue file dated: 09

- 17

- 201 3/12:25:46
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 0.000204 3.10E

- 0 6



### Attachment 6 Results of Cancer DEEM

- FCID Dietary Exposure Analysis for PCA

U.S. EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for DIFLUBENZURON NHANES 2003

- 2008 2

- day

Residue file name: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 108201

Diflubenzuron \ Citrus 2F8015 \ PCA Cancer Food half loq 11

- 19.R08 Adjustment factor #2 used. Analysis Date 11

- 19

- 2 013/07:23:19 Residue file dated: 11

- 19

- 2013/07:21:48
Q* = 0.112
COMMENT 1: PCA Q*

=============================================================================== Total exposure by population subgroup

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

Total Exposure

----------------------------------- Population mg/kg Lif etime risk Subgroup body wt/day (Q*= .112)

-------------------------------------- ------------- -------------- Total US Population 0.000010 1.09E

- 06