Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 1 of 20 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND

POLLUTION PREVENTION



### MEMORANDU M

DATE: July 17 , 2012

SUBJECT: Dinotefuran : Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for a Section 3 Registration

Action on Tuberous and Corm Vegetables Subgroup 1C, Onion Subgroup

3

- 07A, Onion Subgr oup 3

- 07B, Small Fruit Subgroup 13

- 07F, Berry Subgroup 13

- 07H, Peach, Watercress, and Tea (Import).

PC Code: 044312 DP Barcode: 391889

Decision No.: 448130 Registration No. : 86203

- 12 &

- 23, 59639

- 135

Petition No s .: 1E7863 Regulatory Action: Sectio n 3 Risk Assessment Type: Single Chemical Case No.: NA

T XR No.: NA CAS No.: 165252

- 70

- 0

MRID No.: NA 40 CFR: §180.6 0 3

REVIEWER: Cassi L. Walls , Ph.D. , Senior Biologist

R isk Assessment Branch III / Health Effects Division ( HED; 7509 P )

THROUGH: Amelia Acierto, Biologist Julie VanAlstine, Environmental Health Scientist Dietary Exposure Science Advisory Council (DESAC)/HED (7509P)

TO: Barry O’Keefe

, Risk Assessor

Risk Assessment Branch III /HED (7509P)

and

Sidney Jackson/Barbara Madden, RM 05

RIMUER Branch Health Effects Division (7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk

assessments were conducted for the insecticide

, dinotefuran

, using the Dietary Exposure

Evaluation Model DE EM

- FCIDTM, Version 2.03 which use s food consumption data fromDinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 2 of 20 

### the U.S. Department of Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994

- 1996 and 1998

. Dietary risk assessments were performed

to support a Section 3 re gistration application submitted by Interregional Research Project Number 4 (IR

- 4) for three water

- dispersible granule formulations (D INOTEFURAN 20SG, EPA Reg. No. 86203

- 12; STARKLE 70SG, EPA Reg. No.

86203

- 12; D INOTEFURAN 70SG, EPA Reg. No. 59639

- 135) to control sucking and chewing insects infesting berry, small fruit, bulb and green onions, peach and nectarine, tuberous and corm vegetables, and watercress. Additionally, IR

- 4 requested an import

tolerance on tea leaves.

The most recent a cute and chronic aggregate dietary assessments were conducted for

dinotefuran in May 2011 (D 388993

, Barry O’Keefe

, 31

- MAY

- 2011 ).

Acute Dietary Exposure Results and Characterization

.

An u nrefined acute screening

- level dietary assessment was conducted assuming that

100% of crops with the requested uses and currently re gistered uses of dinotefuran are treated and that all treated crops contain residues at tolerance level s

. In addition, default processing factors were assumed for both registered and requested crop uses

. P otential residues in drinking water were included in the analyses based on s urface water results

from the screening

- level FQPA Index Reservoir Screening Tool (FIRST) model as these

val ues were higher than the ground water estimates from the Screening Concen tration in Ground Water ( SCI GROW ) model ( D 394848, Ronald Parker

, 12

- DEC

- 201 1 ). Thus

, the results obtained from the present analyses may be considered highly conservative. At the

95 th 

### percentile of exposure, no population subgroups exceed HED’s level of c oncern: the

U

. S

. population occupied 2 .2 % of the acute population

- a djusted d ose ( a PA D) , while the most highly exposed population subgroup, Children 1

- 2 years old, occupied 5.8 % of the

a PA D

.

Chronic Dietary Exposure Results and Characterization

An unre fined chronic screening

- level dietary assessment was conducted assuming that 100% of crops with the requested uses and currentl y registered uses of dinotefuran are treated and that all treated crops contain residues at tolerance level s . In addition, defau lt processing factors were assumed for both registered and requested crop uses

. Potential residues in drinking water were included in the analyses based on surface water results

from the screening

- level FIRST model as these values were higher than the gro undwater

estimates from the SCIGROW model ( D 394848, Ronald Parker

, 12

- DEC

- 201 1 ). N o population subgroups exceed HED’s level of concern: the U

. S

. population occupied <1 %

of the chronic population

- a djusted d ose (c PA D), while the most highly exposed popula tion subgroup, Chi ldren 1

- 2 years old, occupied 2.6 % of the c PA D.

Cancer Dietary Exposure Results and Characterization

A determination of cancer risk was not performed with DEEM

- FCIDTM as part of the

present assessment, since this chemical was classifie d as “Not likely to be CarcinogenicDinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 3 of 20 

### to Humans” based on negative genotoxicity and carcinogenicity in long term cancer

studies in rats and mice.

I. Introduction

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

acu te 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 i s 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 whi ch discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21

- JUN

- 2000,

web link: http://www.epa.gov/fedrgstr/EPA

- PEST/2000/July/Day

- 12/6061.pdf ; or see SOP 99.6 (20

- AUG

- 1999).

The most recent dietary risk assessment for d inote furan was conducted to support a FIFRA §18 emergency exemption on pom e and stone fruit ( O’Keefe, D 388993

, 31

- MAY

- 20 11 ).

II. Residue Information

Dinotefuran [( RS )

- 1

- methyl

- 2

- nitro

- 3

- (tetrahydro

- 3

- furylmethyl)guanidine] is a Group 4A insecticide for which permanent tolerances have been established under 40 CFR§180.603(a) for the combined residues of dinotefuran and its metabolites DN [1

- methyl

- 3

- (tetrahydro

- 3

- furylmethyl)guanidine], and UF [1

- methyl

- 3

- (tetrahydro

- 3

- furylmethyl)

- urea)]. The tolerance levels established for the following commodities range from 0.05 ppm to 1 5.0 ppm : Brassica (subgroup 5A and 5B), cotton, grape, grape/raisin, potato, potato chips, potato granules/flakes, tomato paste, turnip greens, fruiting vegetables, cucurbits, and leafy vegetables. Tolerances have also been established under 180,603(b) at 0.05 ppm for the fat, meat

, and meat by products of cattle, goat s , hog s , horse s , sheep , and milk. In addition, a FIFRA §18 emergency exemption tolerance currently exists for rice, grain at 2.8 ppm.

The nature of the residue in plants and livestock commo dities is understood (MARC report, TXR #52304, DP293759, L. Cheng, 1/20/2004). In plants, parent dinotefuran and the metabolites DN and UF are the residues of concern for tolerance monitoring, and dinotefuran, DN, UF

, and PHP are the residues of concern f or risk assessment. In livestock, dinotefuran is the residue of concern for tolerance monitoring, and dinotefuran and metabolites UF and FNG in ruminants, and dinotefuran and the metabolite FNG in poultry for risk assessment. Adequate enforcement methods exist for the determination of residues of concern of dinotefuran and its metabolites in/on plant commodities and in

livestock commodities.Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 4 of 20 

### For both the acute and chronic dietary analyse s, the existing and recommended tolerance s were used for each food commodity residue level. Default processing factors , where

were also used. The acute and chronic assessment s also assume that 100% of the crops are treated. Table 1 summarizes the dinotefuran residue levels for the proposed and currently registered crop s used in the acute and chronic dietary assessments.

Table 1. Summary of Dinotefuran Residue Levels For Proposed and Established Tolerances Used in Acute and Chronic Analyses. Commodity Tolerance Level [Acute and Chronic] (ppm) Berry, low growing, ex cept strawberry, subgroup 13

- 07H 3 0.2

Brassica , head and stem, subgroup 5A 1 1.4

Bra s sica , leafy greens, subgroup 5B 1 15.0 Cattle, goat, hog, horse, and sheep 1

F at, meat, and meat by products

Milk 0.05

Cotton, undelinted seed 1 0.4 Fruit, pome 2 1. 0 Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F 3 0.9

Fruit, stone 2 1.0 Grape, raisin 1 2.5 Onion, bulb, subgroup 3

- 07A 3 0.15 Onion, green, subgroup 3

- 07B 3 5 .0

Peach 3 1.0 Potato, chips 1 0.1 Potato, granules/flakes 1 0.15
Rice, grain 2 2.8
Tea, dried 3 50 Tomato, paste 1 1.0 Turnip greens 1 15.0 Vegetable, fruiting, group 8 1 0.7 Vegetable, cucurbit, group 9 1 0.5 Vegetable, leafy, except Brassica , group 4 1 5.0 Vegetable, tuberous and corm, subgroup 1C 3 0.05

Watercress 3 8.0

1 Current Section 3 tolerance

2 Current Section 18 tolerance 3 Proposed tolerance



### III. Drinking Water Data

There are no drinking water monitoring data available on the concentrations of parent dinotefuran, or any of its degradates. EFED provided a tier 1 dinotefuran drinking water assessment with estimated drinking water concentrations (EDWCs) for dinotefuran and its metabolites/degradates (MNG, DN, UF, DN

- 2

- OH, and DN

- 3

- OH) ( D394848, Ronald

Parker , 12

- DEC

- 2011 ). The EDWCs for the metabolites/degradates were reported in parent dinotefuran equivalents. The degradates UF and DN

- 2

- OH are photolysates and are not likely to be formed in the fields of most crops. The formation of these degradates would be a result of direct exposure of parent dinotefuran to surface waters through sprayDinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 5 of 20 

### drift, or through direct application to water, followed by photolysis. The estimated values for DN, UF, and DN

- 2

- OH+DN

- 3

- OH photolysates are considered to be the upper bound estimates, since these degradates are likely to form only in puddles or small water pockets in the field through photolysis, and therefore, these EDWCs should be considered an unrefined assessment. The surface water EDWCs were derived using the FIRST

simulation model. The SCIGROW model was used to derive the ground water EDWCs.

Since a ll EDWC values for the proposed crops are less than the previous EDWC values for pome and stone fruits (D389034) (Table 2) , the pome and stone fruit EDWCs are still recommended for assessing dinotefuran residues in drinking water. Total EDWCs for dinotefuran residues in surface source drinking water are not expected to exceed 91.31 μg/L for the 1 in 10 year daily peak concentration and 25.16 for the 1 in 10 year annual average concentration. In ground water, the EDWC for di notefuran residues is not expected to exceed 3.5 μg/L. Because the surface water estimates are higher than the groundwater estimates, the surface water values, expressed to two significant figures and converted to ppm, were directly incorporated in the DE EM

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

Table 2. Estimated Drinking Water Concentrations for Dinotefuran Total Residues (Parent + Degradates) for Use on Tuberous and Corm Vegetables (Crop Subgr oup 1C), Berry and Small Fruits (Crop Subgroup 13

- 07F), and on Pome and Stone Fruits

.

Crop (Scenario) Percent
Cropped

Area
(PCA) Acute (peak)

Surface Water

Concentration
(μg/L) Annual Average

Surface Water

Concentration
(μg/L) Ground Water

Concentration
(μg/L)

Tuberous and Corm
Vegetables Crop Subgroup

(1C); Berry and Small Fruit
Crop Subgroup ( 13

- 07F). (1
aerial appl @ 0.338 lbs

ai/A) Parent Only 100% 1 33.4 5.5 1.07

Degradates

MNG 100% 1 2.67 1.12 0.33

DN 100% 1 5.38 2.28 0.07

UF 100% 1 2. 82 1.42 0.12

DN

- 2

- OH 2 100% 1 8.23 4.09 0.37 Parent + All Degradates

Tuberous and Corm Vegetables crop subgroup (1C); Berry and Small Fruit crop subgroup ( 13

- 07F). (Assuming All Peaks Occur Simultaneously) 100% 1 52.51 14.42 1.97

Document 044312 D389034 Dinotefuran Section 18 Drinking Water , May 26, 2011

Parent + All Degradates
(Pome & Stone Fruits) (2 100% 1 91.31 25.16 3.5Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 6 of 20 aerial appl @ 0.304 lbs
ai/A) (Assuming All Peaks
Occur Simultaneously)

1 http://www.epa.gov/oppefed1/models/water/pca_adjustment_dwa.html

2 DN

- 2

- OH represents DN

- 2

- OH+DN

- 3

- OH. These two were reported as one metabolite in MRID

45640105

.



### IV. DEEM

- FCIDTM Program and Consumption Information

Dinotefuran acute and chronic dietary exposure assessments were conducted using the

DEEM

- FCIDTM version 2.03 modeling software. It uses food consumption data from the

U.S . Department of Agriculture ( USDA ) CSFII 1994

- 1996 and 1998 food intake surveys

. The 1994

- 96, 98 data are based on the reported consumption of more than 20,000

individuals over two non

- consecutive survey days. Foods “as consumed” (e.g., apple pie)

are linked to EPA

- defined food commodities (e.g.

, apples, peeled fruit

- cooked; fresh or N/S; baked; or wheat flour

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire US population and within population subgroup s. Based on analysis of the 1994

- 96, 98 CSFII consumption data, which took into account dietary patterns of survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, a ll infants (<1 year old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, adults 20

- 49, females 13

- 49, and adults 50+ years old.

For chronic dietary exposure assessment s , 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 for each food/food form is summed

with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg body weight/ day and as a percent of the cRfD . This procedure is performed for each population subgroup.

For acute exposure assessments, individual one

- day food consumption data are used on

an individual

- by

- individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a tota l daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPA D on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per

capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 7 of 20 

### V. Toxicological Information

All information specific to th e t oxicity characteristics of dinotefuran is presented in the

current risk assessment supporting the proposed tolerances ( Barry O’Keefe et. al.

, J uly

2012 ). For the acute and c hronic exposure scenario s , the standard 100 fold UF was applied to account for inter

- species extrapolation and intra

- species variation

.

As previously noted, a cancer risk evaluation is not included in this assessment. To provide an overview of the toxicological profile, a summary of the doses and endpoints

selected for the re le vant dietary exposure scenarios is provided in Table 3

.

Table 3

. Summary of Toxicological Doses and Endpoints for Dinotefuran for Use in Dietary Exposure Risk Assessments

. Exposure/

Scenario Point of Departure Uncertainty/FQPA Safety Factors RfD, PAD, Level

of Concern Study and Toxicological

Effects

Acute Dietary (General Population

, including

Infants and Children) NOAEL=125 mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Acute RfD = 1.25 mg/kg/day

aPAD =1.25 mg/kg/day Developmental Toxicity Study

in Rabbits LOAEL = 300 mg/kg/day based on clinical signs in does (prone position, tremor, erythema) seen following a single dose.

Chronic Dietary (All Popul ations) NOAEL=99.7 mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Chronic RfD =

1.0 mg/kg/day

cPAD = 1.0 mg/kg/day C hronic /Carcinogenicity Study

in Rats

L OAEL = 991 mg/kg/day

based on decreased body weight gain in females and evidence of nephrotoxicity

. Cancer Classification: “Not likely to be Carcinogenic to Humans” based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. Point of Departure (POD) = A data point or an estimated point that is derived from observed do se

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies ). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic).

RfD = reference dose. MOE = margin of exposure. LOC = level of concern.



### VI. 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 estimat e the dietary ex posure of the U

. S

. population and various population subgroups. The results reported in Table 4 are for the general US 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 5 0+ years.

Results of Acute and Chronic Dietary (Food and Drinking Water) Exposure Analysis

Acute dietary risk a nalyses were conducted with the DEEM

- FCI DTM model to form a conservative evaluation of exposure for dinotefuran

. At the 95 th 

### percentile of exposure,Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 8 of 20 

### a ll acute analys e s yielded risk estimates well below the 100% of the aPA D threshold level of concern for each population subgroup. For the U

. S

. Po pulation subgroup, acute aggregate di eta ry risk was calcul ated at 2.2 % of the aPAD wi th an exposure level of

0.0 27 173 mg/kg/day. For the subgroup with the highest calculated exposure, Children 1

- 2 years old

, acute aggregate dietary risk occupied 5.8 % of t he aPA D with an exposure of

0.0 7 2092 mg/kg/day. An overview summarizing the results of the acute dietary

assessments with the population subgroup having the highest exposure noted in bold is presented in Table 4

.

C hronic dietary risk a nalys e s were conduc ted with the DEEM

- FCIDTM model to form a

conservative evaluation of exposure for dinotefuran

. All chronic analys e s yield ed risk

estimates well below the 100% of the c PA D threshold level of concern for each population subgroup. For the U

. S

. Population subg roup, chronic aggregate dietary risk

w as calculated at < 1.0 % of the cPA D with an exposure level of 0.00 8041 mg/kg/day. For the subgroup with the highest calculated exposure, Children 1

- 2 years old

, chronic

aggregate dietary risk occupied 2.6 % of the c PA D with an exposure of 0.02 57 75 mg/kg/day. An overview summarizing the results of the chronic dietary assessment with the population subgroup h aving the highest exposure noted in bold is presented in Table

4

.Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 9 of 20 Table 4 . Result of Acute and Chronic Dietary Exposure and Risk Estimates for Dinotefuran using DEEM

- FCID (food and water)

.

Population Subgroup* Acute Dietary (95 th Percentile) Chronic Dietary

Dietary Exposure (mg/kg/day) % aPAD** Dietary Exposure (mg/kg/day) % cPAD**

General U.S. Population 0.0 27 173 2.2 0.008041 0.8

All Infants (< 1 year old) 0.0617 91 4.9 0.017327 1.7

Children 1

- 2 years old 0.07 2092 5.8 0.025775 2.6

Children 3

- 5 years old 0.052 397 4.2 0.018474 1.8

Childr en 6

- 12 years old 0.028 815 2.3 0.009781 1.0

Youth 13

- 19 years old 0.019 797 1.6 0.006209 0.6

Adults 20

- 49 years old 0.019 742 1.6 0.006311 0.6

Adults 50+ years old 0.0 20109 1.6 0.006453 0.6

Females 13

- 49 years old 0.019 914 1.6 0.006307 0.6

*The values for the highest exposed population for each type of risk assessment are bolded. ** Report %PADs to 2 significant figures.



### VII. Characterization of Inputs/Outputs

The a cute screening

- level dietary assessment conducted with DEEM

- FCIDTM for

dinotefuran is an unrefined analysi s. In addition to tolerance level residues, default processing factors

, and 100% crop treated assumptions, i t utilized conse rvative EDW Cs

derived thro ugh EFED modeling which are unlikely to underestimate the concentration of

dinotefuran in drinking water

. The present DEEM

- FCIDTM analysis assumes that all drinking water will contain dinotefuran at the highest acute E DW C levels modeled by

EFED for ground w ater or surface water

. For these reasons

, it can be concluded that the

DEEM

- FCIDTM analysi s do es not underestimate risk from acute exposure to dinotefuran for the general U

. S

. population and all its subgroups.

The chronic dietary assessment conducted with DEEM

- FCIDTM for dinotefuran is an

unrefined analysis. In addition to tolerance level residues

, default processing factors

, and 100% crop treated assumptions, it utilized conservative EDWCs derived through EFED modeling which are unlikely to underestimate the concentration of dinotefuran in drinking water . The present DEEM

- FCIDTM analysis assumes that all drinking water will

contain dinotefuran at the highest chronic EDWC le vels modeled by EFED for ground water or surface water. For these reasons, it can be concluded that the DEEM

FCIDTM analysis does not underestimate risk from chronic exposure to dinotefuran for the general U

. S

. population and all its subgroups.Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 10 of 20 

### VIII. Conclusions

The conservative acute screening

- level dietary risk assessment conducted wi th DEEM

FCIDTM indicate s that exposure s to dinotefuran are below HED’s level of concern. The

acute dietary risk to dinotefuran is estimated to be 2.2 % of the aPA D for the general U

. S

. population an d 5.8 % of the aPAD f or the most highly exposed population s ubgroup

, Children 1

- 2 years old

. Therefore, HED does not have any concerns for the propos ed

new tolerances of dinotefuran

.

The conservative chro nic dietary risk assessment conducted with DEEM

- FCIDTM indicates that exposures to dinotefuran are below HED’s level of concern. The chronic dietary risk to di notefuran is estimated to be < 1.0 % of the cPAD for the general U

. S

. popu lation and 2.6 % of the cPAD f or the most highly exposed population s ubgroup,

Children 1

- 2 years old. Therefore, HED does not have any concerns for the propos ed new

tolerances of dinotefuran

.

IX. List of Attachments

1. Attachment 1: Acute Dietary Exposure (food + water) Input File.

2. Attachment 2: Acute Dietary Exposure (food + water) Results File.

3

. Attachment 3 : Chronic Dietary Exposure (food + water) Input File.

4

. Attachment 4 : Chronic Dietary Exposure (food + water) Results File.Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 11 of 20 ATTACHMENT 1

Filename: C: \ Documents and Settings \ cwalls \ My Documents \ Cassi \ HED \ Dinotefuran \ new
tolerance 102711 \ acute food+water 012712.R98

Chem ical: Dinotefuran RfD(Chronic): .38 mg/kg bw/day NOEL(Chronic): 38 mg/kg bw/day
RfD(Acute): 1.25 mg/kg bw/day NOEL(Acute): 125 mg/kg bw/day
Date created/last modified: 03

- 28

- 2012/11:59:11/8 Program ver. 2.03 Comment: Acute and Chronic Dietary ( food+drinking water) Assessment

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 01030150 1CD Arrowroot, flour 0.050000 1.000 1.000
01030151 1CD Arrowroot, flour

- babyfood 0.050000 1.000 1.000

01030170 1C D Artichoke, Jerusalem 0.050000 1.000 1.000

01030820 1CD Cassava 0.050000 1.000 1.000

01030821 1CD Cassava

- babyfood 0.050000 1.000 1.000
01031390 1CD Dasheen, corm 0.050000 1.000 1.000 01031660 1CD Ginger 0.050000 1.000 1.000 01031661 1CD Ginger

- babyfood 0.050000 1.000 1.000 01031670 1CD Ginger, dried 0.050000 1.000 1.000 01032960 1C Potato, chips 0.100000 1.000 1.000
01032970 1C Potato, dry (granules/ flakes) 0.150000 1.000 1.000
01032971 1C Potato, dry (granules/ flakes)

- b 0.150000 1.000 1.000
01032980 1C Potato, flour 0.150000 1.000 1.000
01032981 1C Potato, flour

- babyfood 0.150000 1.000 1.000
01032990 1C Potato, tuber, w/peel 0.050000 1.000 1.000
01032991 1C Potato, tuber, w/peel

- babyfood 0.050000 1.000 1.000
01033000 1C Potato, tuber, w/o peel 0.050000 1.000 1.000
01033001 1C Potato, tuber, w/o peel

- babyfood 0.050000 1.000 1.000
01033660 1CD Sweet potato 0.050000 1.000 1.000

01033661 1CD Sw eet potato

- babyfood 0.050000 1.000 1.000
01033710 1CD Tanier, corm 0.050000 1.000 1.000

01033870 1CD Turmeric 0.050000 1.000 1.000

01034060 1CD Yam, true 0.050000 1.000 1.000

01034070 1CD Yam bean 0.050000 1.000 1.000

03001640 3 Garlic 0.150000 1.000 1.000
03001650 3 Garlic, dried 0.150000 1.000 1.000

030 01651 3 Garlic, dried

- babyfood 0.150000 1.000 1.000

03001980 3 Leek 5.000000 1.000 1.000 03002370 3 Onion, dry bulb 0.150000 1.000 1.000 03002371 3 Onion, dry bulb

- baby food 0.150000 1.000 1.000 03002380 3 Onion, dry bulb, dried 0.150000 9.000 1.000 03002381 3 Onion, dry bulb, dried

- babyfood 0.150000 9.000 1.000 03002390 3 Onion, green 5.000000 1.000 1.000

03003380 3 Shallot 0.150000 1.000 1.000
04010050 4A Amaranth, leafy 5.000000 1.000 1.000
04010180 4A Arugula 5.000000 1.000 1.000
04011040 4A Chrysan themum, garland 5.000000 1.000 1.000
04011330 4A Cress, garden 5.000000 1.000 1.000
04011340 4A Cress, upland 5.000000 1.000 1.000
04011380 4A Dandelion, leaves 5.0 00000 1.000 1.000

04011500 4A Endive 5.000000 1.000 1.000

04012040 4A Lettuce, head 5.000000 1.000 1.000
04012050 4A Lettuce, leaf 5.000000 1.000 1.000

04012480 4A Parsley, leaves 5.000000 1.000 1.000

04013130 4A Radicchio 5.000000 1.000 1.000 04013550 4A Spinach 5.000000 1.000 1.000 04013551 4A Spinach

- babyfood 5.000000 1.000 1.000

04020760 4B Cardoon 5.000000 1.000 1.000
04020850 4B Celery 5.000000 1.000 1.000
04020851 4B Celery

- babyfood 5.000000 1.000 1.0 00 04020860 4B Celery, juice 5.000000 1.000 1.000Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 12 of 20 04020870 4B Celtuce 5.000000 1.000 1.000
04021520 4B Fennel, Florence 5.000000 1.000 1.000

04023220 4B Rhubarb 5.000000 1.000 1.000

04023670 4B Swiss chard 5.000000 1.000 1.000

05010610 5A Broccoli 1.400000 1.000 1.000

05010611 5A Broccoli

- babyfood 1.400000 1.000 1.000
05010620 5A Broccoli, Chinese 1.400000 1.000 1.000
05010640 5A Brussels sprouts 1.400000 1.000 1.000
05010690 5A Cabbage 1.400000 1.000 1.000

05010710 5A Cabbage, Chinese, napa 1.400000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 1.400000 1.000 1.000

05010830 5A Cauliflower 1.400000 1.000 1.000

05011960 5A Kohlrabi 1.400000 1.000 1.000

05020630 5B Broccoli raab 15.000000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 15.000000 1.000 1.000

05021170 5B Collards 15.000000 1.000 1.000

05021940 5B Kale 15.000000 1.000 1.000
05022290 5B Mustard greens 15.000000 1.000 1.000
05023180 5B Rape greens 15.000000 1.000 1.000 05023890 5B Turnip, greens 15.000000 1.000 1.000
08001480 8 Eggplant 0.700000 1.000 1.000
08002700 8 Pepper, bell 0.700000 1.000 1.000
08002701 8 Pepper, bell

- babyfood 0.700000 1. 000 1.000 08002710 8 Pepper, bell, dried 0.700000 1.000 1.000 08002711 8 Pepper, bell, dried

- babyfood 0.700000 1.000 1.000
08002720 8 Pepper, nonbell 0.700000 1.000 1.000
08002721 8 Pepp er, nonbell

- babyfood 0.700000 1.000 1.000 08002730 8 Pepper, nonbell, dried 0.700000 1.000 1.000

08003740 8 Tomatillo 0.700000 1.000 1.000

08003750 8 Tomato 0.700000 1.000 1.000

08003751 8 Tomato

- babyfood 0.700000 1.000 1.000
08003760 8 Tomato, paste 1.000000 1.000 1.000
08003761 8 Tomato, paste

- babyfood 1.000000 1.000 1.000

08003 770 8 Tomato, puree 0.700000 3.300 1.000
08003771 8 Tomato, puree

- babyfood 0.700000 3.300 1.000
08003780 8 Tomato, dried 0.700000 14.300 1.000
08003781 8 Tomato, dried

- babyfood 0.700000 14.300 1.000 08003790 8 Tomato, juice 0.700000 1.500 1.000
09010750 9A Cantaloupe 0.500000 1.000 1.000

09010800 9A Casaba 0.500000 1.000 1.000
09011870 9A Honeydew melon 0.500000 1.000 1.000

09013990 9A Watermelon 0.500000 1.000 1.000 09014000 9A Watermelon, juice 0.500000 1.000 1.000
09020210 9B Balsam pe ar 0.500000 1.000 1.000 09020880 9B Chayote, fruit 0.500000 1.000 1.000 09021020 9B Chinese waxgourd 0.500000 1.000 1.000

09021350 9B Cucumber 0.500 000 1.000 1.000 09023080 9B Pumpkin 0.500000 1.000 1.000 09023090 9B Pumpkin, seed 0.500000 1.000 1.000
09023560 9B Squash, summer 0.500000 1.000 1.000

09023561 9 B Squash, summer

- babyfood 0.500000 1.000 1.000 09023570 9B Squash, winter 0.500000 1.000 1.000 09023571 9B Squash, winter

- babyfood 0.500000 1.000 1.000 11000070 11 Apple, fruit with peel 1.000000 1.000 1.000 11000080 11 Apple, peeled fruit 1.000000 1.000 1.000 11000081 11 Apple, peeled fruit

- babyfood 1.000000 1.000 1.000 11000090 11 Apple, dried 1.000000 8.000 1.000 11000091 11 Apple, dried

- babyfood 1.000000 8.000 1.000 11000100 11 Apple, juice 1.000000 1.300 1.000 11000101 11 Apple, juice

- babyfood 1.000000 1.300 1.000
11000110 11 Apple, sauce 1.000000 1.000 1.000
11000111 11 Apple, sauce

- babyfood 1.000000 1.000 1.000
11001290 11 Crabapple 1.000000 1.000 1.000
11002100 11 Loquat 1.000000 1.000 1.000Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 13 of 20 11002660 11 Pear 1.000000 1.000 1.000

11002661 11 Pear

- babyfood 1.000000 1.000 1.000
11002670 11 Pear, dried 1.000000 6.250 1.000

11002680 11 P ear, juice 1.000000 1.000 1.000 11002681 11 Pear, juice

- babyfood 1.000000 1.000 1.000 11003100 11 Quince 1.000000 1.000 1.000 12000120 12 Apricot 1.000000 1.000 1.000 12000121 12 Apricot

- babyfood 1.000000 1.000 1.000 12000130 12 Apricot, dried 1.000000 6.000 1.000 12000140 12 Apricot, juice 1.000000 1.000 1.000

12 000141 12 Apricot, juice

- babyfood 1.000000 1.000 1.000
12000900 12 Cherry 1.000000 1.000 1.000
12000901 12 Cherry

- babyfood 1.000000 1.000 1.000 12000910 12 Cherry, juice 1.000000 1.500 1.000 12000911 12 Cherry, juice

- babyfood 1.000000 1.500 1.000

12002300 12 Nectarine 1.000000 1.000 1.000

12002600 12 Peach 1.000000 1.00 0 1.000

12002601 12 Peach

- babyfood 1.000000 1.000 1.000
12002610 12 Peach, dried 1.000000 7.000 1.000
12002611 12 Peach, dried

- babyfood 1.000000 7.000 1.000
12002620 12 Peach, juice 1.000000 1.000 1.000 12002621 12 Peach, juice

- babyfood 1.000000 1.000 1.000

12002850 12 Plum 1.000000 1.000 1.000

12002851 12 Plum

- babyfood 1. 000000 1.000 1.000
12002860 12 Plum, prune, fresh 1.000000 1.000 1.000
12002861 12 Plum, prune, fresh

- babyfood 1.000000 1.000 1.000 12002870 12 Plum, prune, dried 1.000000 5.000 1.000

1200287 1 12 Plum, prune, dried

- babyfood 1.000000 5.000 1.000 12002880 12 Plum, prune, juice 1.000000 1.400 1.000 12002881 12 Plum, prune, juice

- babyfood 1.000000 1.400 1.000
13020570 13B Blueberry 0.200000 1.000 1.000
13020571 13B Blueberry

- babyfood 0.200000 1.000 1.000
13021740 13B Gooseberry 0.900000 1.000 1.000
15003230 15 Rice, white 2.800000 1.000 1. 000
15003231 15 Rice, white

- babyfood 2.800000 1.000 1.000
15003240 15 Rice, brown 2.800000 1.000 1.000
15003241 15 Rice, brown

- babyfood 2.800000 1.000 1.000
15003250 15 Rice, flour 2.800000 1.000 1.000
15003251 15 Rice, flour

- babyfood 2.800000 1.000 1.000
15003260 15 Rice, bran 2.800000 1.000 1.000
15003261 15 Rice, bran

- babyfood 2.80000 0 1.000 1.000
21000440 M Beef, meat 0.050000 1.000 1.000
21000441 M Beef, meat

- babyfood 0.050000 1.000 1.000
21000450 M Beef, meat, dried 0.050000 1.920 1.000

21000460 M Beef, meat byproducts 0.050000 1.000 1.000
21000461 M Beef, meat byproducts

- babyfood 0.050000 1.000 1.000
21000470 M Beef, fat 0.050000 1.000 1.000
21000471 M Beef,fat

- babyfood 0.050000 1.000 1.000 21000480 M Beef, kidney 0.050000 1.000 1.000
21000490 M Beef, liver 0.050000 1.000 1.000
21000491 M Beef, liver

- babyfood 0.050000 1.000 1.000
23001690 M Goat, meat 0.050000 1.000 1.000
23001700 M Goat, meat byproducts 0.050000 1.000 1.000
23001710 M Goat, fat 0.050000 1.000 1.000 23001720 M Goat, kidney 0.050000 1.000 1.000
23001730 M Goat, liver 0.050000 1.000 1.000

24001890 M Horse, meat 0.050000 1.000 1.000
25002900 M Pork, meat 0.050000 1 .000 1.000
25002901 M Pork, meat

- babyfood 0.050000 1.000 1.000
25002910 M Pork, skin 0.050000 1.000 1.000
25002920 M Pork, meat byproducts 0.050000 1.000 1.000

25002921 M Por k, meat byproducts

- babyfood 0.050000 1.000 1.000
25002930 M Pork, fat 0.050000 1.000 1.000
25002931 M Pork, fat

- babyfood 0.050000 1.000 1.000Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 14 of 20 25002940 M Pork, kidney 0.050000 1.000 1.000
25002950 M Pork, liver 0.050000 1.000 1.000
26003390 M Sheep, meat 0.050000 1.000 1.000
26003391 M Sheep, meat

- babyfood 0.050000 1.000 1.000

2600 3400 M Sheep, meat byproducts 0.050000 1.000 1.000
26003410 M Sheep, fat 0.050000 1.000 1.000
26003411 M Sheep, fat

- babyfood 0.050000 1.000 1.000 26003420 M Sheep, kidney 0.050000 1.000 1.000 26003430 M Sheep, liver 0.050000 1.000 1.000
27002220 D Milk, fat 0.050000 1.000 1.000
27002221 D Milk, fat

- baby food/infant for 0.050000 1.000 1.000
27012230 D Milk, nonfat solids 0.050000 1.000 1.000
27012231 D Milk, nonfat solids

- baby food/in 0.050000 1.000 1.000
27022240 D Milk, water 0.050000 1.000 1.000
27022241 D Milk, wa ter

- babyfood/infant form 0.050000 1.000 1.000 27032251 D Milk, sugar (lactose)

- baby food/ 0.050000 1.000 1.000
28002210 M Meat, game 0.050000 1.000 1.000
29003120 M Rabbit, meat 0.05 0000 1.000 1.000
86010000 O Water, direct, all sources 0.091000 1.000 1.000
86020000 O Water, indirect, all sources 0.091000 1.000 1.000
95001280 O Cottonseed, oil 0.400000 1.000 1.000

95001281 O Cottonseed, oil

- babyfood 0.400000 1.000 1.000
95001300 O Cranberry 0.200000 1.000 1.000
95001301 O Cranberry

- babyfood 0.200000 1.000 1.000 95001310 O Cranberry, dried 0.200000 1.000 1.000 95001320 O Cranberry, juice 0.200000 1.100 1.000 95001321 O Cranberry, juice

- babyfood 0.200000 1.100 1.000
95001750 O Grape 0.900000 1.000 1.00 0 95001760 O Grape, juice 0.900000 1.200 1.000 95001761 O Grape, juice

- babyfood 0.900000 1.200 1.000
95001770 O Grape, leaves 0.900000 1.000 1.000 95001780 O Grape, raisin 2.500000 1.000 1.000 95001790 O Grape, wine and sherry 0.900000 1.000 1.000
95003720 O Tea, dried 50.000000 1.000 1.000

95003980 O Watercress 8.000000 1.000 1.000Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 15 of 20 **ATTACHMENT 2** 

U.S. Environmental Protection Agency Ver. 2.02

DEEM

- FCID ACUTE Analysis for DINOTEFURAN (1994

- 98 data) Residue file: acute food+water 012712.R98 Adjustment fa ctor #2 NOT used. Analysis Date: 03

- 28

- 2012/12:05:13 Residue file dated: 03

- 28

- 2012/11:59:11/8
NOEL (Acute) = 125.000000 mg/kg body

- wt/day Daily totals for food and foodform consumption used. Run Comment: "Acute and Chronic Dietary (food+drinking water) Assessment "

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

Summary calculations (per capita):

95th Percentile 99th Percentile 99.9th Percentile
Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- U.S. Population:

0.027173 2.17 4600 0.052537 4.20 2379 0.104354 8.35 1197

All infants:

0.061791 4.94 2022 0.107263 8.58 1165 0.224004 17.92 558

Children 1

- 2 yrs:

0.072092 5.77 1733 0.121789 9.74 1026 0.189609 15.17 659

Children 3

- 5 yrs:

0.052397 4.19 2385 0.084070 6.73 1486 0.192028 15.36 650

Children 6

- 12 yrs:

0.028815 2.31 4337 0.046091 3.69 2712 0.080245 6.42 1557

Youth 13

- 19 yrs:

0.019797 1.58 6314 0.040851 3.27 3059 0.078850 6.31 1585

Adults 20

- 49 yrs:

0.019742 1 .58 6331 0.032168 2.57 3885 0.055131 4.41 2267 Adults 50+ yrs:

0.020109 1.61 6216 0.034655 2.77 3606 0.067325 5.39 1856

Females 13

- 49 yrs:

0.019914 1.59 6277 0.034487 2.76 3624 0.060003 4.80 2083Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 16 of 20 **ATTACHMENT 3**

Filename: C: \ Documents and Settings \ cwalls \ My Documents \ Cassi \ HED \ Dinotefuran \ new
tolerance 102711 \ chronic food+water 071712.R98

Chemical: Dinotefuran RfD(Chronic): 1 mg/kg bw/day NOEL(Chronic): 99.7 mg/kg bw/day

RfD(Ac ute): 1.25 mg/kg bw/day NOEL(Acute): 125 mg/kg bw/day
Date created/last modified: 07

- 17

- 2012/08:48:21/8 Program ver. 2.03 Comment: Acute and Chronic Dietary (food+drinking water) Assessment

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 01030150 1CD Arrowroot, flour 0.050000 1.000 1.000
01030151 1CD Arrowroot, flour

- babyfood 0.050000 1.000 1.000
01030170 1CD Artichoke, Jerusalem 0.050000 1.000 1.000

01030820 1CD Cassava 0.050000 1.000 1.000

01030821 1CD Cassava

- babyfood 0.050000 1.000 1.000
01031390 1CD Dasheen, corm 0.050000 1.000 1.000 01031660 1CD Ginger 0.050 000 1.000 1.000 01031661 1CD Ginger

- babyfood 0.050000 1.000 1.000 01031670 1CD Ginger, dried 0.050000 1.000 1.000 01032960 1C Potato, chips 0.100000 1.000 1.000

01032970 1 C Potato, dry (granules/ flakes) 0.150000 1.000 1.000
01032971 1C Potato, dry (granules/ flakes)

- b 0.150000 1.000 1.000
01032980 1C Potato, flour 0.150000 1.000 1.000
01032981 1C Potato, flour

- babyfood 0.150000 1.000 1.000
01032990 1C Potato, tuber, w/peel 0.050000 1.000 1.000
01032991 1C Potato, tuber, w/peel

- babyfood 0.050000 1.000 1.000
01033000 1C Potato, tuber, w/o peel 0.050000 1.000 1.000
01033001 1C Potato, tuber, w/o peel

- babyfood 0.050000 1.000 1.000
01033660 1CD Sweet potato 0.050000 1.000 1.000
01033661 1CD Sweet potato

- babyfood 0.050000 1.000 1.000
01033710 1CD Tanier, corm 0.050000 1.000 1.000

01033870 1CD Turmeric 0.050000 1.000 1.000

01034060 1CD Yam, true 0.050000 1.000 1.000

01034070 1CD Yam bean 0.050000 1.000 1.000

03001640 3 Garlic 0.150000 1.000 1.000
03001650 3 Garlic, dried 0.150000 1.000 1.000
03001651 3 Garlic, dried

- babyfood 0.150000 1.000 1.000

03001980 3 L eek 5.000000 1.000 1.000 03002370 3 Onion, dry bulb 0.150000 1.000 1.000 03002371 3 Onion, dry bulb

- babyfood 0.150000 1.000 1.000 03002380 3 Onion, dry bulb, dried 0.150000 9.000 1.000 03002381 3 Onion, dry bulb, dried

- babyfood 0.150000 9.000 1.000 03002390 3 Onion, green 5.000000 1.000 1.000

03003380 3 Shallot 0.150000 1.000 1.000

04 010050 4A Amaranth, leafy 5.000000 1.000 1.000
04010180 4A Arugula 5.000000 1.000 1.000
04011040 4A Chrysanthemum, garland 5.000000 1.000 1.000
04011330 4A Cress, garden 5.000000 1.000 1.000
04011340 4A Cress, upland 5.000000 1.000 1.000
04011380 4A Dandelion, leaves 5.000000 1.000 1.000

04011500 4A Endive 5.000000 1.00 0 1.000
04012040 4A Lettuce, head 5.000000 1.000 1.000
04012050 4A Lettuce, leaf 5.000000 1.000 1.000
04012480 4A Parsley, leaves 5.000000 1.000 1.000

04013130 4A Radicc hio 5.000000 1.000 1.000 04013550 4A Spinach 5.000000 1.000 1.000 04013551 4A Spinach

- babyfood 5.000000 1.000 1.000

04020760 4B Cardoon 5. 000000 1.000 1.000
04020850 4B Celery 5.000000 1.000 1.000
04020851 4B Celery

- babyfood 5.000000 1.000 1.000 04020860 4B Celery, juice 5.000000 1.000 1.000Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 17 of 20 0402087 0 4B Celtuce 5.000000 1.000 1.000
04021520 4B Fennel, Florence 5.000000 1.000 1.000

04023220 4B Rhubarb 5.000000 1.000 1.000

04023670 4B Swiss chard 5.000000 1.000 1.000

05010610 5A Broccoli 1.400000 1.000 1.000

05010611 5A Broccoli

- babyfood 1.400000 1.000 1.000
05010620 5A Broccoli, Chinese 1.400000 1.000 1. 000
05010640 5A Brussels sprouts 1.400000 1.000 1.000
05010690 5A Cabbage 1.400000 1.000 1.000 05010710 5A Cabbage, Chinese, napa 1.400000 1.000 1.000
05010720 5A Cabbage, Ch inese, mustard 1.400000 1.000 1.000

05010830 5A Cauliflower 1.400000 1.000 1.000

05011960 5A Kohlrabi 1.400000 1.000 1.000

05020630 5B Broccoli raab 15.00000 0 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 15.000000 1.000 1.000

05021170 5B Collards 15.000000 1.000 1.000

05021940 5B Kale 15.000000 1.000 1.000

05022290 5B Mustard greens 15.000000 1.000 1.000
05023180 5B Rape greens 15.000000 1.000 1.000 05023890 5B Turnip, greens 15.000000 1.000 1.000
08001480 8 Eggplant 0.700000 1.000 1.000 08002700 8 Pepper, bell 0.700000 1.000 1.000
08002701 8 Pepper, bell

- babyfood 0.700000 1.000 1.000 08002710 8 Pepper, bell, dried 0.700000 1.000 1.000 08002711 8 Pepper, bell, dried

- babyfood 0.700000 1.000 1.000
08002720 8 Pepper, nonbell 0.700000 1.000 1.000
08002721 8 Pepper, nonbell

- babyfood 0.700000 1.000 1.000
08002730 8 Pepper, nonbell, dried 0.700000 1.000 1.000

08003740 8 Tomatillo 0.700000 1.000 1.000

08003750 8 Tomato 0.700000 1.000 1.000

08003751 8 Tomato

- babyfood 0.700000 1 .000 1.000
08003760 8 Tomato, paste 1.000000 1.000 1.000
08003761 8 Tomato, paste

- babyfood 1.000000 1.000 1.000
08003770 8 Tomato, puree 0.700000 3.300 1.000

08003771 8 Tom ato, puree

- babyfood 0.700000 3.300 1.000
08003780 8 Tomato, dried 0.700000 14.300 1.000
08003781 8 Tomato, dried

- babyfood 0.700000 14.300 1.000 08003790 8 Tomato, juice 0.700000 1.500 1.000
09010750 9A Cantaloupe 0.500000 1.000 1.000

09010800 9A Casaba 0.500000 1.000 1.000
09011870 9A Honeydew melon 0.500000 1.000 1.000

0901 3990 9A Watermelon 0.500000 1.000 1.000 09014000 9A Watermelon, juice 0.500000 1.000 1.000
09020210 9B Balsam pear 0.500000 1.000 1.000 09020880 9B Chayote, fruit 0.500000 1.000 1.000 09021020 9B Chinese waxgourd 0.500000 1.000 1.000

09021350 9B Cucumber 0.500000 1.000 1.000 09023080 9B Pumpkin 0.500000 1.000 1.000 09023090 9B Pumpkin, seed 0.500000 1.000 1.000
09023560 9B Squash, summer 0.500000 1.000 1.000
09023561 9B Squash, summer

- babyfood 0.500000 1.000 1.000
09023570 9B Squash, winter 0.500000 1.000 1.000 09023571 9B Squash, winter

- babyfood 0.500000 1.000 1.000 11000070 11 Apple, fruit with peel 1.000000 1.000 1.000 11000080 11 Apple, peeled fruit 1.00 0000 1.000 1.000 11000081 11 Apple, peeled fruit

- babyfood 1.000000 1.000 1.000 11000090 11 Apple, dried 1.000000 8.000 1.000 11000091 11 Apple, dried

- babyfood 1.000000 8.000 1.000

11000100 11 Apple, juice 1.000000 1.300 1.000 11000101 11 Apple, juice

- babyfood 1.000000 1.300 1.000
11000110 11 Apple, sauce 1.000000 1.000 1.000
11000111 11 Apple, sauce

- babyfood 1.000000 1.000 1.000
11001290 11 Crabapple 1.000000 1.000 1.000
11002100 11 Loquat 1.000000 1.000 1.000Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 18 of 20 11002660 11 Pear 1.000000 1.000 1.00 0

11002661 11 Pear

- babyfood 1.000000 1.000 1.000
11002670 11 Pear, dried 1.000000 6.250 1.000 11002680 11 Pear, juice 1.000000 1.000 1.000 11002681 11 Pear, juice

- b abyfood 1.000000 1.000 1.000 11003100 11 Quince 1.000000 1.000 1.000 12000120 12 Apricot 1.000000 1.000 1.000 12000121 12 Apricot

- babyfood 1.000000 1.000 1.000 12000130 12 Apricot, dried 1.000000 6.000 1.000 12000140 12 Apricot, juice 1.000000 1.000 1.000 12000141 12 Apricot, juice

- babyfood 1.000000 1.000 1.000

12000900 12 Cherry 1.000000 1.000 1.000
12000901 12 Cherry

- babyfood 1.000000 1.000 1.000 12000910 12 Cherry, juice 1.000000 1.500 1.000 12000911 12 Cherry, juice

- babyfood 1.000000 1.500 1.000

12002300 12 Nectarine 1.000000 1.000 1.000

12002600 12 Peach 1.000000 1.000 1.000

12002601 12 Peach

- babyfood 1.000000 1.000 1.000

1 2002610 12 Peach, dried 1.000000 7.000 1.000
12002611 12 Peach, dried

- babyfood 1.000000 7.000 1.000 12002620 12 Peach, juice 1.000000 1.000 1.000 12002621 12 Peach, juice

- babyf ood 1.000000 1.000 1.000

12002850 12 Plum 1.000000 1.000 1.000

12002851 12 Plum

- babyfood 1.000000 1.000 1.000
12002860 12 Plum, prune, fresh 1.000000 1.0 00 1.000
12002861 12 Plum, prune, fresh

- babyfood 1.000000 1.000 1.000 12002870 12 Plum, prune, dried 1.000000 5.000 1.000 12002871 12 Plum, prune, dried

- babyfood 1.000000 5.000 1.000
12002880 12 Plum, prune, juice 1.000000 1.400 1.000 12002881 12 Plum, prune, juice

- babyfood 1.000000 1.400 1.000
13020570 13B Blueberry 0.200000 1.000 1.000
13020571 13B Blueberry

- babyfood 0 .200000 1.000 1.000
13021740 13B Gooseberry 0.900000 1.000 1.000
15003230 15 Rice, white 2.800000 1.000 1.000
15003231 15 Rice, white

- babyfood 2.800000 1.000 1.000

150032 40 15 Rice, brown 2.800000 1.000 1.000
15003241 15 Rice, brown

- babyfood 2.800000 1.000 1.000
15003250 15 Rice, flour 2.800000 1.000 1.000
15003251 15 Rice, flour

- babyfood 2.800000 1.000 1.000
15003260 15 Rice, bran 2.800000 1.000 1.000
15003261 15 Rice, bran

- babyfood 2.800000 1.000 1.000
21000440 M Beef, meat 0.050000 1.000 1 .000
21000441 M Beef, meat

- babyfood 0.050000 1.000 1.000
21000450 M Beef, meat, dried 0.050000 1.920 1.000
21000460 M Beef, meat byproducts 0.050000 1.000 1.000
21000461 M Beef, meat byproducts

- babyfood 0.050000 1.000 1.000
21000470 M Beef, fat 0.050000 1.000 1.000
21000471 M Beef,fat

- babyfood 0.050000 1.000 1.000 21000480 M Beef, kidney 0.0500 00 1.000 1.000
21000490 M Beef, liver 0.050000 1.000 1.000
21000491 M Beef, liver

- babyfood 0.050000 1.000 1.000
23001690 M Goat, meat 0.050000 1.000 1.000

23001700 M Goat, meat byproducts 0.050000 1.000 1.000
23001710 M Goat, fat 0.050000 1.000 1.000 23001720 M Goat, kidney 0.050000 1.000 1.000
23001730 M Goat, liver 0.050000 1.000 1.000
24001890 M Horse, meat 0.050000 1.000 1.000
25002900 M Pork, meat 0.050000 1.000 1.000
25002901 M Pork, meat

- babyfood 0.050000 1.000 1.000
25002910 M Pork, skin 0.050000 1.000 1.000
25002920 M Pork, meat byproducts 0.050000 1.000 1.000
25002921 M Pork, meat byproducts

- babyfood 0.050000 1.000 1.000
25002930 M Pork, fat 0.050000 1.000 1.000
25002931 M Pork, fat

- babyfood 0.050000 1.000 1.000Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 19 of 20 25002940 M Pork, kidney 0.050000 1.000 1.000
25002950 M Pork, liver 0.050000 1.000 1.000
26003390 M Sheep, meat 0.050000 1.000 1.000
26003391 M Sheep, meat

- babyfood 0.050000 1.000 1.000
26003400 M Sheep, meat byproducts 0.050000 1.000 1.000

26003410 M Sh eep, fat 0.050000 1.000 1.000
26003411 M Sheep, fat

- babyfood 0.050000 1.000 1.000 26003420 M Sheep, kidney 0.050000 1.000 1.000 26003430 M Sheep, liver 0.050000 1.000 1.000
27002220 D Milk, fat 0.050000 1.000 1.000
27002221 D Milk, fat

- baby food/infant for 0.050000 1.000 1.000
27012230 D Milk, nonfat solids 0.050000 1.000 1.000

270 12231 D Milk, nonfat solids

- baby food/in 0.050000 1.000 1.000
27022240 D Milk, water 0.050000 1.000 1.000
27022241 D Milk, water

- babyfood/infant form 0.050000 1.000 1.000 27032251 D Milk, sugar (lactose )

- baby food/ 0.050000 1.000 1.000
28002210 M Meat, game 0.050000 1.000 1.000
29003120 M Rabbit, meat 0.050000 1.000 1.000
86010000 O Water, direct, all sources 0.025000 1.000 1.000
86020000 O Water, indirect, all sources 0.025000 1.000 1.000
95001280 O Cottonseed, oil 0.400000 1.000 1.000
95001281 O Cottonseed, oil

- babyfood 0.400000 1.000 1.000

95001300 O Cranber ry 0.200000 1.000 1.000
95001301 O Cranberry

- babyfood 0.200000 1.000 1.000 95001310 O Cranberry, dried 0.200000 1.000 1.000 95001320 O Cranberry, juice 0.2 00000 1.100 1.000 95001321 O Cranberry, juice

- babyfood 0.200000 1.100 1.000
95001750 O Grape 0.900000 1.000 1.000 95001760 O Grape, juice 0.900000 1.200 1.000

95001761 O Grape, juice

- babyfood 0.900000 1.200 1.000
95001770 O Grape, leaves 0.900000 1.000 1.000 95001780 O Grape, raisin 2.500000 1.000 1.000 95001790 O Grape, wine and sherry 0.900000 1.000 1.000
95003720 O Tea, dried 50.000000 1.000 1.000

95003980 O Watercress 8.000000 1.000 1.000Dinotefuran Dietary Exposure and Risk Assessment DP Number: 391889

PC Code: 044312

___________________________________________________________________________________ ___

Page 20 of 20 ATTACHMENT 4

.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chronic analysis for DINOTEFURAN (1994

- 98 data)

Residue file name: C: \ Documents and Settings \ cwalls \ My

Documents \ Cassi \ HED \ Dinotefuran \ new tolerance 102711 \ chronic food+water

071712.R98 Adjustment factor #2 NOT used. Analysis Date 07

- 17

- 2012/08:57:07 Residue file dated: 07

- 17

- 2012/08:48:21/8 Reference dose (RfD, Chronic) = 1 mg/kg bw/day COMMENT 1: Acute and Chronic Dietary (food+drinki ng water) Assessment

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

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

Total Exposure

----------------------------------- Population mg/kg Percent of

Subgroup body wt/d ay Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.008041 0.8%

U.S. Population (spring season) 0.008025 0.8%

U.S. Population (summer season) 0.008199 0.8% U.S. Population (autumn season) 0.008032 0.8% U.S. Population (winter season) 0.007898 0.8%

Northeast region 0.008628 0.9% Midwest region 0.007608 0.8% Southern region 0.007441 0.7% Western region 0.008930 0. 9%

Hispanics 0.008781 0.9%

Non

- hispanic whites 0.007460 0.7%

Non

- hispanic blacks 0.008796 0.9%

Non

- hisp/non

- white/non

- black 0.013658 1.4%

All infants (< 1 year) 0.017327 1.7% Nursing infants 0.009114 0.9%

Non

- nursing infants 0.020445 2.0%

Children 1

- 6 yrs 0.020093 2.0%

Children 7

- 12 yrs 0.009096 0.9%

Females 13

- 19 (not preg or nursing) 0.005975 0.6%
Females 20+ (not preg or nursing) 0.006454 0.6%

Females 13

- 50 yrs 0.006668 0.7% Females 13+ (preg/not nursing) 0.006849 0.7% Females 13+ (nursing) 0.007243 0.7%

Males 13

- 19 yrs 0.006405 0.6%
Males 20+ yrs 0.006249 0.6%

Seniors 55+ 0.006482 0.6%

Children 1

- 2 y rs 0.025775 2.6%

Children 3

- 5 yrs 0.018474 1.8%

Children 6

- 12 yrs 0.009781 1.0%

Youth 13

- 19 yrs 0.00 6209 0.6%

Adults 20

- 49 yrs 0.006311 0.6%
Adults 50+ yrs 0.006453 0.6%

Females 13

- 49 yrs 0.006307 0.6%

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