Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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### UNITED STATES ENVIRONMEN TAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUT ION PREVENTION 

### MEMORANDUM

DATE: 4/25/13

SUBJECT: Dinotefuran : Acute and Chronic Aggregat e Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 18 for Use on Pome and Stone Fruits in MI.

PC Code: 044312 DP Barcode: D410585 Decision No.: 476056 Registration Nos.: 59639-135, 10163-317 Petition No.: NA Regulatory Action: Section 18 Risk Assessment Type: Dietary Case No.: NA TXR No.: NA CAS No.: 165252-70-0 MRID No.: NA 40 CFR: §180.603



### REVIEWER: Nancy Dodd, Chemist Risk Assessment Branch III (RAB3) Health Effects Division (HED; 7509P)

THROUGH: Douglas Dotson, Chemist Julie L. Van Alstine, MPH, Environmental Health Scientist Dietary Exposure Science Advi sory Council (DESAC)/HED (7509P)

TO: Tawanda Maignan/Andrea Conrath, RM #9 Risk Integration, Minor Use, and Emergency Response Branch Registration Division (7505P)

Executive Summary

Acute and chronic aggregat e dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-F CID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examina tion Survey, What We Eat in America (NHANES/WWEIA). The analyses were conduc ted in support of a human-health risk assessment for the proposed Section 18 emerge ncy exemption requested by MI for use of dinotefuran on pome and stone fruits. This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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### Acute Dietary Exposure Assessment

An unrefined acute screening-level dietary assessment was conducted assuming that all of the crops associated with the requested and currently registered us es of dinotefuran are 100% treated and that all treated crops cont ain tolerance-level residues, corrected for additional residues which are of concern for the risk assessm ent only. Correction factors were used to add residues of the meta bolites PHP (6-hydroxy-5-(2-hydroxyethyl)-1- methyl-1,3-diazinane-2-ylidene- N -nitroamine) in plants, UF (1-methyl-3-(tetrahydro-3- furylmethyl)-urea) and FNG in rumina nts, and FNG (2-nitro-1-(tetrahydro-3- furylmethyl)guanidine) in poultry (refer to the adjustment factor #2 column of the residue input file). In addition, default processing factors were assumed for both registered and requested crop uses unless separate tolerances were established or empirical processing data were available. Potential residues in drinking water were included in the analyses based on surface water results from the provision ally modified Tier 1 Rice Model v.1.0 as these values were higher than the gro undwater estimates fr om the Screening Concentration in Ground Water (SCI-GRO W) model (D397490, James Wolf, 7-AUG2012). The results obtained from the present di etary analyses may be considered highly conservative. At the 95 th 

### percentile of exposure, no population subgroups exceed HED’s level of concern. The U.S. population occupi ed 3.7% of the acut e population-adjusted dose (aPAD), while the most highly exposed population subgroup, chil dren 1-2 years old, occupied 12% of the aPAD.

Chronic Dietary Exposure Assessment

An unrefined chronic screening-level dietar y assessment was conducted assuming that all of the crops associated with the requested and currently registered uses of dinotefuran are 100% treated and that all treat ed crops contain tolerance-le vel residues, corrected for additional residues which are of concern for the risk assessm ent only. Correction factors were used to add residues of the metabolites PHP in plants, UF and FNG in ruminants, and FNG in poultry (refer to the adjustment factor #2 column of the residue input file). In addition, default processing factors were assumed for both registered and requested crop uses unless separate tolera nces were established or em pirical processing data were available. Potential residues in drinking wa ter were included in the analyses based on surface water results from the modified Tier 1 Rice Model v.1.0 as these values were higher than the groundwater estimates from the SCI-GROW model (D397490, James Wolf, 7-AUG-2012). No population subgroups exceed HED’s level of concern. The U.S. population occupied 1.7% of the chroni c population-adjusted dose (cPAD), while the most highly exposed population subgroup, ch ildren 1-2 years old, occupied 5.7% of the cPAD.

Cancer Dietary Exposure Assessment

A determination of cancer risk was not pe rformed with DEEM-FCID as part of the present assessment, since this chemical was clas sified as “not likely to be carcinogenic to humans” based on negative genotoxicity and carcinogenicity in long term cancer studies in rats and mice.Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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### I. Introduction

Dietary risk assessment incorpor ates 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 ha s concluded will result in no unreasonable adverse health effects). This dose is refe rred to as the population- adjusted dose (PAD). The PAD is equivalent to point of depart ure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chroni c exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link: http://www.epa.gov/fedrgstr/E PA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment fo r dinotefuran was conducted by Cassi Walls (8/20/12, D398050).

II. Residue Information

Dinotefuran (( RS )-1-methyl-2-nitro-3-(tetrahydro-3-fu rylmethyl)guanidine) is a Group 4A insecticide for which permanent tolera nces have been esta blished under 40 CFR §180.603. Tolerances have been established on various plant commodities at levels ranging from 0.05 ppm to 50 ppm under 40 CFR §180.603(a). For plants, compliance with the tolerance levels is to be determin ed by measuring only the sum of dinotefuran and its metabolites DN [1-methyl-3-(tetra hydro-3-furylmethyl)gua nidine] and UF [1- methyl-3-(tetrahydro-3-furylmethyl)u rea)], calculated as the st oichiometric equivalent of dinotefuran. Tolerances have also been establis hed under 40 CFR §180.603(b) for livestock commodities at levels of 0.01 ppm or 0.05 ppm. For livestock commodities, compliance with the tolerance levels is to be determined by measuri ng only dinotefuran. A use in food/feed handling establishments (F HE) with associated tolerances of 0.01 ppm is pending.

The nature of the residue in plants and livestock commodities 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 for risk assessment. In livestock, dinotefuran is the residue of con cern for tolerance monito ring; the residues of concern for risk assessment are dinotefuran and metabolites UF and FNG in ruminants, and dinotefuran and the metabolite FNG in poultry.

For both the acute and chronic dietary anal yses, the existing, pending, and recommended tolerances were used for each food commodity residue level. Default processing factors were also used except for dry potatoes, to mato paste, and grape raisins for which tolerances are established, and for grape ju ice and tomato puree for which processing studies are available which show that the to lerance for the raw agricultural commodity isDinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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### adequate to cover the processed commodit y. For these commodities, the processing factor was set to 1.0. The acute and chronic assessments also assume that 100% of the crops are treated. Tables 1 through 4 summari ze the dinotefuran resi due levels used in the acute and chronic dietary assessments.

The pending FHE use was only included in the chronic assessment according to current HED policy.

HED has concluded that no changes are needed to the existing tolerances for livestock commodities as a resu lt of the proposed Section 18 uses on pome and stone fruits.

The USDA Pesticide Data Program (PDP) mon itored pesticide residues in catfish in 2008, 2009, and 2010. Over this 3-year period, PDP analyzed 1479 samples of catfish for dinotefuran residues. None of the samples contained detectable residues. As a result, residues in fish were not included in the assessment.

Correction factors were used to add residues of PHP in plants , UF and FNG in ruminants, and FNG in poultry to the dietary assessments (refer to the Tables 1 through 4 below and to the adjustment factor #2 column of the re sidue input files). Th e correction factors are based on the percentages of th e total radioactive residues (% TRR) attributed to PHP in plants, UF and FNG in ruminants, and FNG in poultry. The % TRR is expressed in parent equivalents. The % TRR informa tion was found in the dinotefuran metabolism studies (Metabolism Assessment Review Committee [MARC] mee ting memo, TXR No. 0052304, D293759, L. Cheng, 1/20/04). The memo contains % TRR data for apples, lettuce, potato, rape seed, rice, ruminants ( goats), and poultry (hens) . For this dietary assessment, the data are translated from appl es to pome fruit; from lettuce to vegetable, leafy, except Brassica , group 4; from potato to subgroup 1C; and from rape seed to cottonseed; the highest % TRR available fo r plants was used for the other plant commodities. For each commodity, the %TRR representing the sum of the residues included only in the risk assessment was r ounded to the closest 1% and then added to 100% before entering in the adjustment factor #2 column of the resi due input f ile as the correction factor.

Table 1. Residues of PHP in Plants. Commodity PHP (% TRR*) Reported Rounded Cotton, undelinted seed 7.0 7 Fruit, pome 13.5 14 Potato, chips 6.9 7 Potato, granules/flakes 6.9 7 Rice, grain 7.0 7 Vegetable, leafy, except Brassica

, group 4 5.1 5

Vegetable, tuberous and corm, subgroup 1C 6.9 7

All other plant commodities 13.5 14 

### * The % TRR is expressed in parent equivalents.Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 5 of 25 Table 2. Residues of UF and FNG in Ruminants. Commodity UF (% TRR*) FNG (% TRR*) UF + FNG (% TRR*) Reported Reported Reported Rounded Fat of cattle, goat, hog, horse, and sheep 7.4 3.1 10.5 10

Meat of cattle, goat, hog, horse, and sheep 14.6 6.5 21.1 21

Meat byproducts of cattle, goat, hog, horse, and sheep** 7.4 20.1 27.5 28

Milk 8.7 6.9 15.6 16 * The % TRR is expressed in parent equivalents. **The highest % reported for fat, liver, and kidney is used for meat byproducts.

Table 3. Residues of FNG in Poultry. Commodity FNG (% TRR*) Reported Calculated Rounded Egg 13.1% egg white 8.0% egg yolk 9.7% combined egg white and yolk*** 10% combined egg white and yolk Poultry, meat byproducts** 6.5 --- 6 * The % TRR is expressed in parent equivalents. **The highest % reported for fat and liver is used for meat byproducts.

*** The whole egg (100% with shell) is composed of 31.0% yolk, 58.0% egg white, and 11.0% shell. To express egg yolk and egg white as 100%, egg yolk would be 34.83% and egg white would be 65.17%. To calculate the % TRR in combined egg white an d egg yolk: 13% TRR x 34.83/100 + 8.0% TRR x 65.17/100 = 9.7% TRR in combined egg white and egg yolk.

Table 4. Summary of Dinotefuran Tolerances a nd Correction Factors Used in Acute and Chronic Analyses. Commodity Tolerance Levels 1 (ppm) Correction Factors 4 (%) Plant Commodities Berry, low growing, except strawberry, subgroup 13-07H 0.2 114

Brassica , head and stem, subgroup 5A 1.4 114

Brassica , leafy greens, subgroup 5B 15.0 114 Cotton, undelinted seed 0.4 107 Fruit, pome 2 2.0 114 Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F 0.9 114

Fruit, stone 2 2.0 114 Grape, raisin 2.5 114 Onion, bulb, subgroup 3-07A 0.15 114 Onion, green, subgroup 3-07B 5.0 114 Potato, chips 0.1 107 Potato, granules/flakes 0.15 107 Rice, grain 9.0 107 Tea, dried 50 114 Tomato, paste 1.0 114Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 6 of 25 Table 4. Summary of Dinotefuran Tolerances a nd Correction Factors Used in Acute and Chronic Analyses. Commodity Tolerance Levels 1 (ppm) Correction Factors 4 (%) Turnip, greens 15.0 114 Vegetable, fruiting, group 8 0.7 114 Vegetable, cucurbit, group 9 0.5 114 Vegetable, leafy, except Brassica

, group 4 5.0 105

Vegetable, tuberous and corm, subgroup 1C 0.05 107

Watercress 8.0 114 All food/feed items (other than those already covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments where food products are held, processed or prepared 3 0.01 114

Livestock Commodities Egg 0.01 110 Fat of cattle, goat, hog, horse, and sheep 0.05 110

Meat of cattle, goat, hog, horse, and sheep 0.05 121

Meat byproducts of cattle, goat, hog, horse, and sheep 0.05 128

Meat byproducts of poultry 0.01 106
Milk 0.05 116

1 Residue levels are established tolerances unless otherwise indicated.

2 Recommended Section 18 tolerances. Since peach is a stone fruit, the lower es tablished peach tolerance of 1.0 ppm is not used.

3 Pending tolerance

4 Correction factors were used to add residues of PHP in plants, UF and FNG in ruminants, and FNG in poultry to the dietary assessment. The correction factors were entered in the adjustment factor #2 column of the residue input files to correct for residues included in the risk assessment but not in the tolerance.



### III. Drinking Water Data

The drinking water residues used in the di etary risk assessment were provided by the Environmental Fate and Effects Divisi on (EFED) in the following memorandum: “ Tier I Drinking Water Concentrations fo r Dinotefuran for Section 3 New Use on Rice” (D397490, J. Wolf & J. Hetrick, 8/7/12) and in corporated directly into this dietary assessment. Water residues were incor porated in the DEEM-FCID into the food categories “water, direct, all sources” a nd “water, indirect, all sources.”

There are no drinking water monitoring data available on the concentrations of parent dinotefuran or any of its degr adates. EFED provided a Tier 1 dinotefuran drinking water assessment with estimated drinking water c oncentrations (EDWCs) for dinotefuran and its metabolite/degradate DN. The modifi ed Tier 1 Rice Model v.1.0 was used to determine EDWCs for surface water. Groundwat er EDWCs were obtained with the Tier 1 SCI-GROW model v.2.3 usi ng the turf scenario.Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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### Table 5 summarizes the surface water EDWCs for dinotefuran and DN degradate. The peak concentration is 269 μg/L a nd the longer term concentration ( ≈ average) would depend upon retention time (10 to 30 days).

Table 5. Tier 1 Surface Water EDWCs (μg/L) for Drinking Water Risk Assessment for the Use of Dinotefuran on Rice. Based upon tota l toxic residues (Dinotefuran + DN).

Peak Retention Time

10 day 30 day 60 day 100 day 150 day

269 257 253 248 240 198



### The ground water EDWC, obtained using the Tier 1 SCI-GROW, is the same value for the turf use and the Section 18 rice use; 4.90 μg/L for both the acute and chronic exposures. Since the application rate for turf (1 application at 0.54 lb ai/A) is higher than for rice and since SCI-GROW is not site or crop dependent, the resulting water concentration is considered to be conservative.

Because the surface water estimates are hi gher than the groundwater estimates, the surface water values, expressed to two signifi cant figures and converted to ppm, were directly incorporated in th e DEEM-FCID into the food cat egories “water, direct, all sources” and “water, indi rect, all sources.” The peak value of 269 μ g/L 

### (ppb) was used in the acute assessment and the 10 day retention time value of 257 μ g/L 

### was used in the chronic assessment.

IV. DEEM-FCIDTM Program and Consumption Information

Dinotefuran acute and chroni c dietary exposure assessments were conducted using the DEEM-FCID, Version 3.16, which incorpor ates 2003-2008 consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consumption of more than 20,000 individuals over tw o 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 develope d jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups. However, fo r acute exposure assessment, consumption data are retained as individual consumption events. Based on an alysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns of survey respondents, HED concluded that it is most appropriate to re port risk for the following population subgroups: the general U.S. population, all infants (< 1 year old), children 1-2, children 3-5, childre n 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years old.

For a chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juic e) 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 re sidue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on theDinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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### commodity residue list to arrive at the to tal 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.

For an acute exposure assessment, 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 a nd summed to obtain a total daily pesticide exposure for a deterministic exposure asse ssment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of expos ures is expressed as a perc entage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a percapita (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 analyses performed at all levels of refineme nt. However, for deterministic assessments, any significant differences in user vs. pe r capita exposure and ri sk are specifically identified and noted in the risk assessment.

V. Toxicological Information

All information specific to the toxicity charac teristics of dinotefuran is presented in the most recent risk assessment (D398048, Barry O’Keefe, 8/31/12). For the acute and chronic exposure scenarios, the standard 100 fold uncertainty factor was applied to account for inter-species extrapolatio n and intra-species variation.

As previously noted, a cancer risk evaluati on is not included in this assessment. To provide an overview of the toxicological profile, a summary of the doses and endpoints selected for the relevant di etary exposure scenarios is provided in Table 6.

Table 6. Summary of Toxicological Doses and Endpoints for Dinotefura n for Use in Dietary Exposure Risk Assessments. Exposure/ Scenario Point of Departure Uncertainty/FQPA Safety Factors RfD, PAD, Level of Concern for Risk Assessment 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 indicative of neurotoxicity in does (hypoactivity, prone position, panting, tremor and erythema) seen following the first dose on Gestation Day 6. Chronic Dietary (All Populations) 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 Chronic Toxicity/Carcinogenicity Study in Rats LOAEL = 991 mg/kg/day based on decreased body weight gain and nephrotoxicity.
Cancer Classification: “Not likely to be Carcinogenic to Humans” based on theDinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 9 of 25 absence of significant tumor incr eases in two adequate rodent carcinogenicity studies. Point of Departure (POD) = A data point or an estimate d point that is derived from observed dose-response data and used to mark the beginning of extra polation 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.



### VI. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM-FCID analyses estimate the dietary exposure and risk of the U.S. population and various popul ation subgroups. The results reported in Table 7 are for the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-1 2, youth 13-19, females 13-49, adults 20-49, and adults 50-99

years.

Results of Acute and Chronic Dietary (F ood and Drinking Water) Exposure and Risk Analyses

Acute dietary risk analyses were conduc ted with the DEEM-FCID model to form a conservative evaluation of exposur e for dinotefuran. At the 95 th 

### percentile of exposure, all acute analyses yielded risk estimates well below the 100% of the aPAD threshold level of concern for each population subgroup. For the general U.S. population, acute aggregate dietary risk was 3.7% of the aP AD with an estimated exposure level of 0.046286 mg/kg/day. For the subgroup with the hi ghest exposure, chil dren 1-2 years old, acute aggregate dietary risk occupied 12% of the aPAD with an estimated exposure of 0.152112 mg/kg/day. An overview summarizi ng the results of the acute dietary assessments with the population subgroup ha ving the highest exposur e noted in bold is presented in Table 7.

Chronic dietary risk analyses were conduc ted with the DEEM-FCID model to form a conservative evaluation of exposure for dinotef uran. All chronic analyses yielded risk estimates well below the 100% of the cP AD threshold level of concern for each population subgroup. For the general U.S. populat ion, chronic aggregate dietary risk was 1.7% of the cPAD with an estimated exposure level of 0.016633 mg/kg/day. For the subgroup with the highest exposure, children 1- 2 years old, chronic ag gregate dietary risk occupied 5.7% of the cPAD with an estimated exposure of 0.056650 mg/kg/day. An overview summarizing the results of the chro nic dietary assessment with the population subgroup having the highest exposure noted in bold is presented in Table 7.Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 10 of 25 Table 7. Summary of Dietary (Food and Drinki ng Water) Exposure and Risk for Dinotefuran.

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 0.046286 3.7 0.016633 1.7

All Infants (< 1 year old) 0.132460 11 0.047675 4.8

Children 1-2 years old* 0.152112 12 0.056650 5.7

Children 3-5 years old 0.099267 7.9 0.037044 3.7

Children 6-12 years old 0.051696 4.1 0.018991 1.9

Youth 13-19 years old 0.031125 2.5 0.011261 1.1

Adults 20-49 years old 0.034765 2.8 0.013944 1.4

Adults 50-99 years old 0.031484 2.5 0.013404 1.3

Females 13-49 years old 0.033791 2.7 0.013432 1.3

* The subpopulation with the highest risk estimates is bolded.



### VII. Characterization of Inputs/Outputs

The acute screening-level dietary as sessment conducted with DEEM-FCID for dinotefuran is an unrefined an alysis. In addition to tolera nce-level residue s corrected for additional residues of concern for the risk assessment, default pr ocessing factors as appropriate, 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 pres ent DEEM-FCID analysis assumes that all drinking water will contain di notefuran at the highest acu te EDWC levels modeled by EFED for groundwater or surface water. For these reasons, it can be concluded that the DEEM-FCID analysis does not underestimate ri sk from acute exposure to dinotefuran for the general U.S. population and all its subgroups.

The chronic dietary assessment conducted with DEEM-FCID for dinotefuran is an unrefined analysis. In addition to tolerance-level residues corrected for additional residues of concern for the risk assessment , default processing factors, and 100% crop treated assumptions, it utilized conservative EDWC s derived through EFED modeling which are unlikely to underestimate the concen tration of dinotefuran in drinking water. The present DEEM-FCID analysis assumes that all drinking water will contain dinotefuran at the highest chronic EDWC levels modeled by EFED for groundwater or surface water. For these reasons, it can be c oncluded that the DEEM-FCID analysis does not underestimate risk from chronic exposur e to dinotefuran for the general U.S. population and all its subgroups.Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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### VIII. Conclusions

The conservative acute screen ing-level dietary risk asse ssment conducted with DEEMFCID indicates that exposure s to dinotefuran are below HED’s level of concern. The acute dietary risk to dinotefuran is estimated to be 3.7% of the aPAD for the general U.S. population and 12% of the aPAD for the most highly exposed population subgroup, children 1-2 years old. Therefore, HED doe s not have any concerns for the proposed Section 18 tolerances for dinotefuran.

The conservative chronic dietary risk asse ssment conducted with DEEM-FCID indicates that exposures to dinotefuran are below HED’s level of concern. The chronic dietary risk to dinotefuran is estimated to be 1.7% of the cPAD for the general U.S. population and 5.7% of the cPAD for the most highly expos ed population subgroup, children 1-2 years old. Therefore, HED does not have any concer ns for the proposed Section 18 tolerances for dinotefuran.

IX. List of Attachments

Attachment 1: Acut e Residue Input File Attachment 2: Acute Results File Attachment 3: Chronic Residue Input File Attachment 4: Chronic Results FileDinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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### Attachment 1: Acut e Residue Input File

Filename: C:\Documents and Settings\NDODD\My Documents\DEEM Version 3.16\Dinotefuran 2013\Dinotefuran acute 042513.R08 Chemical: Dinotefuran RfD(Chronic): 1 mg/kg bw/day NOEL(Chronic): 99.7 mg/kg bw/day RfD(Acute): 1.25 mg/kg bw/day NOEL(Acute): 125 mg/kg bw/day Date created/last modified: 04-25-2013/10:04:01 Program ver. 3.16, 03-08-d

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0103015000 1CD Arrowroot, flour 0.050000 1.000 1.070 0103015001 1CD Arrowroot, flour-babyfood 0.050000 1.000 1.070 0103017000 1CD Artichoke, Jerusalem 0.050000 1.000 1.070
0103082000 1CD Cassava 0.050000 1.000 1.070 0103082001 1CD Cassava-babyfood 0.050000 1.000 1.070 0103139000 1CD Dasheen, corm 0.050000 1.000 1.070 0103166000 1CD Ginger 0.050000 1.000 1.070 0103166001 1CD Ginger-babyfood 0.050000 1.000 1.070 0103167000 1CD Ginger, dried 0.050000 1.000 1.070 0103296000 1C Potato, chips 0.100000 1.000 1.070 0103297000 1C Potato, dry (granules/ flakes) 0.150000 1.000 1.070 0103297001 1C Potato, dry (granules/ flakes)-b 0.150000 1.000 1.070 0103298000 1C Potato, flour 0.150000 1.000 1.070 0103298001 1C Potato, flour-babyfood 0.150000 1.000 1.070 0103299000 1C Potato, tuber, w/peel 0.050000 1.000 1.070 0103299001 1C Potato, tuber, w/peel-babyfood 0.050000 1.000 1.070 0103300000 1C Potato, tuber, w/o peel 0.050000 1.000 1.070 0103300001 1C Potato, tuber, w/o peel-babyfood 0.050000 1.000 1.070 0103366000 1CD Sweet potato 0.050000 1.000 1.070 0103366001 1CD Sweet potato-babyfood 0.050000 1.000 1.070 0103371000 1CD Tanier, corm 0.050000 1.000 1.070 0103387000 1CD Turmeric 0.050000 1.000 1.070 0103406000 1CD Yam, true 0.050000 1.000 1.070 0103407000 1CD Yam bean 0.050000 1.000 1.070 0301165000 3A Garlic, bulb 0.150000 1.000 1.140 0301165001 3A Garlic, bulb-babyfood 0.150000 1.000 1.140 0301237000 3A Onion, bulb 0.150000 1.000 1.140 0301237001 3A Onion, bulb-babyfood 0.150000 1.000 1.140 0301238000 3A Onion, bulb, dried 0.150000 9.000 1.140 0301238001 3A Onion, bulb, dried-babyfood 0.150000 9.000 1.140 0301338000 3A Shallot, bulb 0.150000 1.000 1.140 0302103000 3B Chive, fresh leaves 5.000000 1.000 1.140
0302198000 3B Leek 5.000000 1.000 1.140 0302239000 3B Onion, green 5.000000 1.000 1.140 0302338500 3B Shallot, fresh leaves 5.000000 1.000 1.140 0401005000 4A Amaranth, leafy 5.000000 1.000 1.050 0401018000 4A Arugula 5.000000 1.000 1.050 0401104000 4A Chrysanthemum, garland 5.000000 1.000 1.050 0401133000 4A Cress, garden 5.000000 1.000 1.050 0401134000 4A Cress, upland 5.000000 1.000 1.050 0401138000 4A Dandelion, leaves 5.000000 1.000 1.050 0401150000 4A Endive 5.000000 1.000 1.050 0401204000 4A Lettuce, head 5.000000 1.000 1.050 0401205000 4A Lettuce, leaf 5.000000 1.000 1.050 0401248000 4A Parsley, leaves 5.000000 1.000 1.050 0401313000 4A Radicchio 5.000000 1.000 1.050 0401355000 4A Spinach 5.000000 1.000 1.050 0401355001 4A Spinach-babyfood 5.000000 1.000 1.050
0402076000 4B Cardoon 5.000000 1.000 1.050 0402085000 4B Celery 5.000000 1.000 1.050 0402085001 4B Celery-babyfood 5.000000 1.000 1.050 0402086000 4B Celery, juice 5.000000 1.000 1.050
0402087000 4B Celtuce 5.000000 1.000 1.050 0402152000 4B Fennel, Florence 5.000000 1.000 1.050
0402322000 4B Rhubarb 5.000000 1.000 1.050 0402367000 4B Swiss chard 5.000000 1.000 1.050 0501061000 5A Broccoli 1.400000 1.000 1.140 0501061001 5A Broccoli-babyfood 1.400000 1.000 1.140 0501062000 5A Broccoli, Chinese 1.400000 1.000 1.140 0501064000 5A Brussels sprouts 1.400000 1.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 13 of 25 0501069000 5A Cabbage 1.400000 1.000 1.140 0501071000 5A Cabbage, Chinese, napa 1.400000 1.000 1.140 0501072000 5A Cabbage, Chinese, mustard 1.400000 1.000 1.140 0501083000 5A Cauliflower 1.400000 1.000 1.140 0501196000 5A Kohlrabi 1.400000 1.000 1.140 0502063000 5B Broccoli raab 15.000000 1.000 1.140 0502070000 5B Cabbage, Chinese, bok choy 15.000000 1.000 1.140
0502117000 5B Collards 15.000000 1.000 1.140
0502194000 5B Kale 15.000000 1.000 1.140 0502229000 5B Mustard greens 15.000000 1.000 1.140 0502318000 5B Rape greens 15.000000 1.000 1.140 0502389000 5B Turnip, greens 15.000000 1.000 1.140 0801374000 8A Tomatillo 0.700000 1.000 1.140
0801375000 8A Tomato 0.700000 1.000 1.140 0801375001 8A Tomato-babyfood 0.700000 1.000 1.140 0801376000 8A Tomato, paste 1.000000 1.000 1.140 0801376001 8A Tomato, paste-babyfood 1.000000 1.000 1.140 0801377000 8A Tomato, puree 0.700000 1.000 1.140 D29019 Full comment: D290191 0801377001 8A Tomato, puree-babyfood 0.700000 1.000 1.140 0801378000 8A Tomato, dried 0.700000 14.300 1.140 0801378001 8A Tomato, dried-babyfood 0.700000 14.300 1.140 0801379000 8A Tomato, juice 0.700000 1.500 1.140 0801380000 8A Tomato, Tree 0.700000 1.000 1.140 0802148000 8BC Eggplant 0.700000 1.000 1.140
0802234000 8BC Okra 0.700000 1.000 1.140 0802270000 8B Pepper, bell 0.700000 1.000 1.140 0802270001 8B Pepper, bell-babyfood 0.700000 1.000 1.140 0802271000 8B Pepper, bell, dried 0.700000 1.000 1.140 0802271001 8B Pepper, bell, dried-babyfood 0.700000 1.000 1.140 0802272000 8BC Pepper, nonbell 0.700000 1.000 1.140 0802272001 8BC Pepper, nonbell-babyfood 0.700000 1.000 1.140 0802273000 8BC Pepper, nonbell, dried 0.700000 1.000 1.140 0901075000 9A Cantaloupe 0.500000 1.000 1.140 0901187000 9A Honeydew melon 0.500000 1.000 1.140
0901399000 9A Watermelon 0.500000 1.000 1.140 0901400000 9A Watermelon, juice 0.500000 1.000 1.140 0902021000 9B Balsam pear 0.500000 1.000 1.140 0902088000 9B Chayote, fruit 0.500000 1.000 1.140 0902102000 9B Chinese waxgourd 0.500000 1.000 1.140
0902135000 9B Cucumber 0.500000 1.000 1.140 0902308000 9B Pumpkin 0.500000 1.000 1.140 0902309000 9B Pumpkin, seed 0.500000 1.000 1.140 0902356000 9B Squash, summer 0.500000 1.000 1.140 0902356001 9B Squash, summer-babyfood 0.500000 1.000 1.140 0902357000 9B Squash, winter 0.500000 1.000 1.140 0902357001 9B Squash, winter-babyfood 0.500000 1.000 1.140 1100007000 11 Apple, fruit with peel 2.000000 1.000 1.140 1100008000 11 Apple, peeled fruit 2.000000 1.000 1.140 1100008001 11 Apple, peeled fruit-babyfood 2.000000 1.000 1.140 1100009000 11 Apple, dried 2.000000 8.000 1.140 1100009001 11 Apple, dried-babyfood 2.000000 8.000 1.140 1100010000 11 Apple, juice 2.000000 1.300 1.140 Sectio Full comment: Section 18 1100010001 11 Apple, juice-babyfood 2.000000 1.300 1.140 1100011000 11 Apple, sauce 2.000000 1.000 1.140 1100011001 11 Apple, sauce-babyfood 2.000000 1.000 1.140 1100129000 11 Crabapple 2.000000 1.000 1.140 1100173500 11 Goji berry 0.700000 1.000 1.140 1100210000 11 Loquat 2.000000 1.000 1.140
1100266000 11 Pear 2.000000 1.000 1.140 1100266001 11 Pear-babyfood 2.000000 1.000 1.140 1100267000 11 Pear, dried 2.000000 6.250 1.140 1100268000 11 Pear, juice 2.000000 1.000 1.140 1100268001 11 Pear, juice-babyfood 2.000000 1.000 1.140 1100310000 11 Quince 2.000000 1.000 1.140 1201090000 12A Cherry 2.000000 1.000 1.140 1201090001 12A Cherry-babyfood 2.000000 1.000 1.140 1201091000 12A Cherry, juice 2.000000 1.500 1.140 1201091001 12A Cherry, juice-babyfood 2.000000 1.500 1.140 1202012000 12B Apricot 2.000000 1.000 1.140 1202012001 12B Apricot-babyfood 2.000000 1.000 1.140 1202013000 12B Apricot, dried 2.000000 6.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 14 of 25 1202014000 12B Apricot, juice 2.000000 1.000 1.140 1202014001 12B Apricot, juice-babyfood 2.000000 1.000 1.140 1202230000 12B Nectarine 2.000000 1.000 1.140
1202260000 12B Peach 2.000000 1.000 1.140 1202260001 12B Peach-babyfood 2.000000 1.000 1.140 1202261000 12B Peach, dried 2.000000 7.000 1.140 1202261001 12B Peach, dried-babyfood 2.000000 7.000 1.140 1202262000 12B Peach, juice 2.000000 1.000 1.140 1202262001 12B Peach, juice-babyfood 2.000000 1.000 1.140
1203285000 12C Plum 2.000000 1.000 1.140 1203285001 12C Plum-babyfood 2.000000 1.000 1.140 1203286000 12C Plum, prune, fresh 2.000000 1.000 1.140 1203286001 12C Plum, prune, fresh-babyfood 2.000000 1.000 1.140 1203287000 12C Plum, prune, dried 2.000000 5.000 1.140 Sectio Full comment: Section 18 1203287001 12C Plum, prune, dried-babyfood 2.000000 5.000 1.140 1203288000 12C Plum, prune, juice 2.000000 1.400 1.140 1203288001 12C Plum, prune, juice-babyfood 2.000000 1.400 1.140 1302057000 13B Blueberry 0.200000 1.000 1.140 1302057001 13B Blueberry-babyfood 0.200000 1.000 1.140 1302174000 13B Gooseberry 0.900000 1.000 1.140 1304175000 13D Grape 0.900000 1.000 1.140 1304176000 13D Grape, juice 0.900000 1.000 1.140 D29019
Full comment: D290191 1304176001 13D Grape, juice-babyfood 0.900000 1.000 1.140 1304179000 13D Grape, wine and sherry 0.900000 1.000 1.140 1307130000 13G Cranberry 0.200000 1.000 1.140 1307130001 13G Cranberry-babyfood 0.200000 1.000 1.140 1307131000 13G Cranberry, dried 0.200000 1.000 1.140 1307132000 13G Cranberry, juice 0.200000 1.100 1.140 1307132001 13G Cranberry, juice-babyfood 0.200000 1.100 1.140 1500323000 15 Rice, white 9.000000 1.000 1.070 1500323001 15 Rice, white-babyfood 9.000000 1.000 1.070 1500324000 15 Rice, brown 9.000000 1.000 1.070 1500324001 15 Rice, brown-babyfood 9.000000 1.000 1.070 1500325000 15 Rice, flour 9.000000 1.000 1.070 1500325001 15 Rice, flour-babyfood 9.000000 1.000 1.070 1500326000 15 Rice, bran 9.000000 1.000 1.070 1500326001 15 Rice, bran-babyfood 9.000000 1.000 1.070 2003128000 20C Cottonseed, oil 0.400000 1.000 1.070 2003128001 20C Cottonseed, oil-babyfood 0.400000 1.000 1.070 3100044000 31 Beef, meat 0.050000 1.000 1.210 3100044001 31 Beef, meat-babyfood 0.050000 1.000 1.210 3100045000 31 Beef, meat, dried 0.050000 1.920 1.210 3100046000 31 Beef, meat byproducts 0.050000 1.000 1.280 3100046001 31 Beef, meat byproducts-babyfood 0.050000 1.000 1.280 3100047000 31 Beef, fat 0.050000 1.000 1.100 3100047001 31 Beef, fat-babyfood 0.050000 1.000 1.100 3100048000 31 Beef, kidney 0.050000 1.000 1.280 3100049000 31 Beef, liver 0.050000 1.000 1.280 3100049001 31 Beef, liver-babyfood 0.050000 1.000 1.280 3200169000 32 Goat, meat 0.050000 1.000 1.210 3200170000 32 Goat, meat byproducts 0.050000 1.000 1.280 3200171000 32 Goat, fat 0.050000 1.000 1.100 3200172000 32 Goat, kidney 0.050000 1.000 1.280 3200173000 32 Goat, liver 0.050000 1.000 1.280 3300189000 33 Horse, meat 0.050000 1.000 1.210 3400290000 34 Pork, meat 0.050000 1.000 1.210 3400290001 34 Pork, meat-babyfood 0.050000 1.000 1.210 3400291000 34 Pork, skin 0.050000 1.000 1.280 3400292000 34 Pork, meat byproducts 0.050000 1.000 1.280 3400292001 34 Pork, meat byproducts-babyfood 0.050000 1.000 1.280 3400293000 34 Pork, fat 0.050000 1.000 1.100 3400293001 34 Pork, fat-babyfood 0.050000 1.000 1.100 3400294000 34 Pork, kidney 0.050000 1.000 1.280 3400295000 34 Pork, liver 0.050000 1.000 1.280 3500339000 35 Sheep, meat 0.050000 1.000 1.210 3500339001 35 Sheep, meat-babyfood 0.050000 1.000 1.210 3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.280 3500341000 35 Sheep, fat 0.050000 1.000 1.100 3500341001 35 Sheep, fat-babyfood 0.050000 1.000 1.100 3500342000 35 Sheep, kidney 0.050000 1.000 1.280 3500343000 35 Sheep, liver 0.050000 1.000 1.280Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 15 of 25 3600222000 36 Milk, fat 0.050000 1.000 1.160 3600222001 36 Milk, fat-baby food/infant formu 0.050000 1.000 1.160 3600223000 36 Milk, nonfat solids 0.050000 1.000 1.160 3600223001 36 Milk, nonfat solids-baby food/in 0.050000 1.000 1.160 3600224000 36 Milk, water 0.050000 1.000 1.160 3600224001 36 Milk, water-babyfood/infant form 0.050000 1.000 1.160 3600225001 36 Milk, sugar (lactose)-baby food/ 0.050000 1.000 1.160 4000094000 40 Chicken, liver 0.010000 1.000 1.060 4000095000 40 Chicken, meat byproducts 0.010000 1.000 1.060 4000095001 40 Chicken, meat byproducts-babyfoo 0.010000 1.000 1.060 4000097000 40 Chicken, skin 0.010000 1.000 1.060 4000097001 40 Chicken, skin-babyfood 0.010000 1.000 1.060 5000383000 50 Turkey, liver 0.010000 1.000 1.060 5000383001 50 Turkey, liver-babyfood 0.010000 1.000 1.060 5000384000 50 Turkey, meat byproducts 0.010000 1.000 1.060 5000384001 50 Turkey, meat byproducts-babyfood 0.010000 1.000 1.060 5000386000 50 Turkey, skin 0.010000 1.000 1.060 5000386001 50 Turkey, skin-babyfood 0.010000 1.000 1.060 6000302000 60 Poultry, other, liver 0.010000 1.000 1.060 6000303000 60 Poultry, other, meat byproducts 0.010000 1.000 1.060 6000305000 60 Poultry, other, skin 0.010000 1.000 1.060 7000145000 70 Egg, whole 0.010000 1.000 1.100 7000145001 70 Egg, whole-babyfood 0.010000 1.000 1.100 7000146000 70 Egg, white 0.010000 1.000 1.100 7000146001 70 Egg, white (solids)-babyfood 0.010000 1.000 1.100 7000147000 70 Egg, yolk 0.010000 1.000 1.100 7000147001 70 Egg, yolk-babyfood 0.010000 1.000 1.100 8601000000 86A Water, direct, all sources 0.269000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.269000 1.000 1.000 9500177000 O Grape, leaves 0.900000 1.000 1.140 9500178000 O Grape, raisin 2.500000 1.000 1.140 9500372000 O Tea, dried 50.000000 1.000 1.140 9500373000 O Tea, instant 50.000000 1.000 1.140
9500398000 O Watercress 8.000000 1.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 16 of 25 

### Attachment 2: Acute Results File

U.S. EPA Ver. 3.16, 03-08-d DEEM-FCID ACUTE Analysis for DINOTEFURAN NHANES 2003-2008 2-Day Residue file: Dinotefuran acute 042513.R08 Adjustment factor #2 used. Analysis Date: 04-25-2013/10:05:53 Residue file dated: 04-25-2013/10:04:01 NOEL (Acute) = 125.000000 mg/kg body-wt/day RAC/FF intake summed over 24 hours

Run Comment: ""

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

Summary calculations--per capita:

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

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population:
0.046286 3.70 2700 0.095806 7.66 1304 0.202291 16.18 617 All Infants:
0.132460 10.60 943 0.207078 16.57 603 0.325585 26.05 383 Children 1-2:
0.152112 12.17 821 0.236367 18.91 528 0.382991 30.64 326 Children 3-5:
0.099267 7.94 1259 0.155523 12.44 803 0.238357 19.07 524 Children 6-12:
0.051696 4.14 2417 0.091500 7.32 1366 0.163874 13.11 762 Youth 13-19:
0.031125 2.49 4016 0.050792 4.06 2461 0.074714 5.98 1673 Adults 20-49:
0.034765 2.78 3595 0.053555 4.28 2334 0.087480 7.00 1428 Adults 50-99:
0.031484 2.52 3970 0.046971 3.76 2661 0.085766 6.86 1457 Female 13-49:
0.033791 2.70 3699 0.050648 4.05 2468 0.079495 6.36 1572Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 17 of 25 

### Attachment 3: Chronic Residue Input File

Filename: C:\Documents and Settings\NDODD\My Documents\DEEM Version 3.16\Dinotefuran 2013\Dinotefuran chronic 042513.R08 Chemical: Dinotefuran RfD(Chronic): 1 mg/kg bw/day NOEL(Chronic): 99.7 mg/kg bw/day RfD(Acute): 1.25 mg/kg bw/day NOEL(Acute): 125 mg/kg bw/day Date created/last modified: 04-25-2013/10:15:24 Program ver. 3.16, 03-08-d Comment: Acute and Chronic Dietary (food+drinking water) Assessment

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101050000 1AB Beet, garden, roots 0.010000 1.000 1.140 0101050001 1AB Beet, garden, roots-babyfood 0.010000 1.000 1.140 0101052000 1A Beet, sugar 0.010000 1.000 1.140 0101052001 1A Beet, sugar-babyfood 0.010000 1.000 1.140 0101053000 1A Beet, sugar, molasses 0.010000 1.000 1.140 0101053001 1A Beet, sugar, molasses-babyfood 0.010000 1.000 1.140
0101067000 1AB Burdock 0.010000 1.000 1.140
0101078000 1AB Carrot 0.010000 1.000 1.140 0101078001 1AB Carrot-babyfood 0.010000 1.000 1.140 0101079000 1AB Carrot, juice 0.010000 1.000 1.140 0101084000 1AB Celeriac 0.010000 1.000 1.140 0101100000 1AB Chicory, roots 0.010000 1.000 1.140 0101168000 1AB Ginseng, dried 0.010000 1.000 1.140 0101190000 1AB Horseradish 0.010000 1.000 1.140 0101250000 1AB Parsley, turnip rooted 0.010000 1.000 1.140 0101251000 1AB Parsnip 0.010000 1.000 1.140 0101251001 1AB Parsnip-babyfood 0.010000 1.000 1.140 0101314000 1AB Radish, roots 0.010000 1.000 1.140 0101316000 1AB Radish, Oriental, roots 0.010000 1.000 1.140 0101327000 1AB Rutabaga 0.010000 1.000 1.140 0101331000 1AB Salsify, roots 0.010000 1.000 1.140 0101388000 1AB Turnip, roots 0.010000 1.000 1.140 0103015000 1CD Arrowroot, flour 0.050000 1.000 1.070 0103015001 1CD Arrowroot, flour-babyfood 0.050000 1.000 1.070 0103017000 1CD Artichoke, Jerusalem 0.050000 1.000 1.070
0103082000 1CD Cassava 0.050000 1.000 1.070 0103082001 1CD Cassava-babyfood 0.050000 1.000 1.070 0103139000 1CD Dasheen, corm 0.050000 1.000 1.070 0103166000 1CD Ginger 0.050000 1.000 1.070 0103166001 1CD Ginger-babyfood 0.050000 1.000 1.070 0103167000 1CD Ginger, dried 0.050000 1.000 1.070 0103296000 1C Potato, chips 0.100000 1.000 1.070 0103297000 1C Potato, dry (granules/ flakes) 0.150000 1.000 1.070 0103297001 1C Potato, dry (granules/ flakes)-b 0.150000 1.000 1.070 0103298000 1C Potato, flour 0.150000 1.000 1.070 0103298001 1C Potato, flour-babyfood 0.150000 1.000 1.070 0103299000 1C Potato, tuber, w/peel 0.050000 1.000 1.070 0103299001 1C Potato, tuber, w/peel-babyfood 0.050000 1.000 1.070 0103300000 1C Potato, tuber, w/o peel 0.050000 1.000 1.070 0103300001 1C Potato, tuber, w/o peel-babyfood 0.050000 1.000 1.070 0103366000 1CD Sweet potato 0.050000 1.000 1.070 0103366001 1CD Sweet potato-babyfood 0.050000 1.000 1.070 0103371000 1CD Tanier, corm 0.050000 1.000 1.070 0103387000 1CD Turmeric 0.050000 1.000 1.070 0103406000 1CD Yam, true 0.050000 1.000 1.070 0103407000 1CD Yam bean 0.050000 1.000 1.070 0200051000 2 Beet, garden, tops 0.010000 1.000 1.140 0200101000 2 Chicory, tops 0.010000 1.000 1.140 0200140000 2 Dasheen, leaves 0.010000 1.000 1.140 0200315000 2 Radish, tops 0.010000 1.000 1.140 0200317000 2 Radish, Oriental, tops 0.010000 1.000 1.140 0200332000 2 Salsify, tops 0.010000 1.000 1.140 0301165000 3A Garlic, bulb 0.150000 1.000 1.140 0301165001 3A Garlic, bulb-babyfood 0.150000 1.000 1.140 0301237000 3A Onion, bulb 0.150000 1.000 1.140 0301237001 3A Onion, bulb-babyfood 0.150000 1.000 1.140 0301238000 3A Onion, bulb, dried 0.150000 9.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 18 of 25 0301238001 3A Onion, bulb, dried-babyfood 0.150000 9.000 1.140 0301338000 3A Shallot, bulb 0.150000 1.000 1.140 0302103000 3B Chive, fresh leaves 5.000000 1.000 1.140
0302198000 3B Leek 5.000000 1.000 1.140 0302239000 3B Onion, green 5.000000 1.000 1.140 0302338500 3B Shallot, fresh leaves 5.000000 1.000 1.140 0401005000 4A Amaranth, leafy 5.000000 1.000 1.050 0401018000 4A Arugula 5.000000 1.000 1.050 0401104000 4A Chrysanthemum, garland 5.000000 1.000 1.050 0401133000 4A Cress, garden 5.000000 1.000 1.050 0401134000 4A Cress, upland 5.000000 1.000 1.050 0401138000 4A Dandelion, leaves 5.000000 1.000 1.050 0401150000 4A Endive 5.000000 1.000 1.050 0401204000 4A Lettuce, head 5.000000 1.000 1.050 0401205000 4A Lettuce, leaf 5.000000 1.000 1.050 0401248000 4A Parsley, leaves 5.000000 1.000 1.050 0401313000 4A Radicchio 5.000000 1.000 1.050 0401355000 4A Spinach 5.000000 1.000 1.050 0401355001 4A Spinach-babyfood 5.000000 1.000 1.050
0402076000 4B Cardoon 5.000000 1.000 1.050 0402085000 4B Celery 5.000000 1.000 1.050 0402085001 4B Celery-babyfood 5.000000 1.000 1.050 0402086000 4B Celery, juice 5.000000 1.000 1.050
0402087000 4B Celtuce 5.000000 1.000 1.050 0402152000 4B Fennel, Florence 5.000000 1.000 1.050
0402322000 4B Rhubarb 5.000000 1.000 1.050 0402367000 4B Swiss chard 5.000000 1.000 1.050 0501061000 5A Broccoli 1.400000 1.000 1.140 0501061001 5A Broccoli-babyfood 1.400000 1.000 1.140 0501062000 5A Broccoli, Chinese 1.400000 1.000 1.140 0501064000 5A Brussels sprouts 1.400000 1.000 1.140 0501069000 5A Cabbage 1.400000 1.000 1.140 0501071000 5A Cabbage, Chinese, napa 1.400000 1.000 1.140 0501072000 5A Cabbage, Chinese, mustard 1.400000 1.000 1.140 0501083000 5A Cauliflower 1.400000 1.000 1.140 0501196000 5A Kohlrabi 1.400000 1.000 1.140 0502063000 5B Broccoli raab 15.000000 1.000 1.140 0502070000 5B Cabbage, Chinese, bok choy 15.000000 1.000 1.140
0502117000 5B Collards 15.000000 1.000 1.140
0502194000 5B Kale 15.000000 1.000 1.140 0502229000 5B Mustard greens 15.000000 1.000 1.140 0502318000 5B Rape greens 15.000000 1.000 1.140 0502389000 5B Turnip, greens 15.000000 1.000 1.140 0600347000 6 Soybean, seed 0.010000 1.000 1.140 0600349000 6 Soybean, soy milk 0.010000 1.000 1.140 0600349001 6 Soybean, soy milk-babyfood or in 0.010000 1.000 1.140 0600350000 6 Soybean, oil 0.010000 1.000 1.140 0600350001 6 Soybean, oil-babyfood 0.010000 1.000 1.140 0601043000 6A Bean, snap, succulent 0.010000 1.000 1.140 0601043001 6A Bean, snap, succulent-babyfood 0.010000 1.000 1.140 0601257000 6A Pea, edible podded, succulent 0.010000 1.000 1.140 0601349500 6AB Soybean, vegetable 0.010000 1.000 1.140 0602031000 6B Bean, broad, succulent 0.010000 1.000 1.140 0602033000 6B Bean, cowpea, succulent 0.010000 1.000 1.140 0602037000 6B Bean, lima, succulent 0.010000 1.000 1.140 0602255000 6B Pea, succulent 0.010000 1.000 1.140 0602255001 6B Pea, succulent-babyfood 0.010000 1.000 1.140 0602259000 6B Pea, pigeon, succulent 0.010000 1.000 1.140 0603030000 6C Bean, black, seed 0.010000 1.000 1.140 0603032000 6C Bean, broad, seed 0.010000 1.000 1.140 0603034000 6C Bean, cowpea, seed 0.010000 1.000 1.140 0603035000 6C Bean, great northern, seed 0.010000 1.000 1.140 0603036000 6C Bean, kidney, seed 0.010000 1.000 1.140 0603038000 6C Bean, lima, seed 0.010000 1.000 1.140 0603039000 6C Bean, mung, seed 0.010000 1.000 1.140 0603040000 6C Bean, navy, seed 0.010000 1.000 1.140 0603041000 6C Bean, pink, seed 0.010000 1.000 1.140 0603042000 6C Bean, pinto, seed 0.010000 1.000 1.140 0603098000 6C Chickpea, seed 0.010000 1.000 1.140 0603098001 6C Chickpea, seed-babyfood 0.010000 1.000 1.140 0603099000 6C Chickpea, flour 0.010000 1.000 1.140 0603182000 6C Guar, seed 0.010000 1.000 1.140 0603182001 6C Guar, seed-babyfood 0.010000 1.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 19 of 25 0603203000 6C Lentil, seed 0.010000 1.000 1.140 0603256000 6C Pea, dry 0.010000 1.000 1.140 0603256001 6C Pea, dry-babyfood 0.010000 1.000 1.140 0603258000 6C Pea, pigeon, seed 0.010000 1.000 1.140 0603348000 6C Soybean, flour 0.010000 1.000 1.140 0603348001 6C Soybean, flour-babyfood 0.010000 1.000 1.140 0801374000 8A Tomatillo 0.700000 1.000 1.140
0801375000 8A Tomato 0.700000 1.000 1.140 0801375001 8A Tomato-babyfood 0.700000 1.000 1.140 0801376000 8A Tomato, paste 1.000000 1.000 1.140 0801376001 8A Tomato, paste-babyfood 1.000000 1.000 1.140 0801377000 8A Tomato, puree 0.700000 1.000 1.140 D29019 Full comment: D290191 0801377001 8A Tomato, puree-babyfood 0.700000 1.000 1.140 0801378000 8A Tomato, dried 0.700000 14.300 1.140 0801378001 8A Tomato, dried-babyfood 0.700000 14.300 1.140 0801379000 8A Tomato, juice 0.700000 1.500 1.140 0801380000 8A Tomato, Tree 0.700000 1.000 1.140 0802148000 8BC Eggplant 0.700000 1.000 1.140
0802234000 8BC Okra 0.700000 1.000 1.140 0802270000 8B Pepper, bell 0.700000 1.000 1.140 0802270001 8B Pepper, bell-babyfood 0.700000 1.000 1.140 0802271000 8B Pepper, bell, dried 0.700000 1.000 1.140 0802271001 8B Pepper, bell, dried-babyfood 0.700000 1.000 1.140 0802272000 8BC Pepper, nonbell 0.700000 1.000 1.140 0802272001 8BC Pepper, nonbell-babyfood 0.700000 1.000 1.140 0802273000 8BC Pepper, nonbell, dried 0.700000 1.000 1.140 0901075000 9A Cantaloupe 0.500000 1.000 1.140 0901187000 9A Honeydew melon 0.500000 1.000 1.140
0901399000 9A Watermelon 0.500000 1.000 1.140 0901400000 9A Watermelon, juice 0.500000 1.000 1.140 0902021000 9B Balsam pear 0.500000 1.000 1.140 0902088000 9B Chayote, fruit 0.500000 1.000 1.140 0902102000 9B Chinese waxgourd 0.500000 1.000 1.140
0902135000 9B Cucumber 0.500000 1.000 1.140 0902308000 9B Pumpkin 0.500000 1.000 1.140 0902309000 9B Pumpkin, seed 0.500000 1.000 1.140 0902356000 9B Squash, summer 0.500000 1.000 1.140 0902356001 9B Squash, summer-babyfood 0.500000 1.000 1.140 0902357000 9B Squash, winter 0.500000 1.000 1.140 0902357001 9B Squash, winter-babyfood 0.500000 1.000 1.140 1001106000 10A Citron 0.010000 1.000 1.140 1001107000 10A Citrus hybrids 0.010000 1.000 1.140 1001108000 10A Citrus, oil 0.010000 1.000 1.140 1001240000 10A Orange 0.010000 1.000 1.140 1001241000 10A Orange, juice 0.010000 1.000 1.140 1001241001 10A Orange, juice-babyfood 0.010000 1.000 1.140 1001242000 10A Orange, peel 0.010000 1.000 1.140 1001369000 10A Tangerine 0.010000 1.000 1.140 1001370000 10A Tangerine, juice 0.010000 1.000 1.140 1002197000 10B Kumquat 0.010000 1.000 1.140
1002199000 10B Lemon 0.010000 1.000 1.140 1002200000 10B Lemon, juice 0.010000 1.000 1.140 1002200001 10B Lemon, juice-babyfood 0.010000 1.000 1.140 1002201000 10B Lemon, peel 0.010000 1.000 1.140 1002206000 10B Lime 0.010000 1.000 1.140 1002207000 10B Lime, juice 0.010000 1.000 1.140 1002207001 10B Lime, juice-babyfood 0.010000 1.000 1.140 1003180000 10C Grapefruit 0.010000 1.000 1.140 1003181000 10C Grapefruit, juice 0.010000 1.000 1.140
1003307000 10C Pummelo 0.010000 1.000 1.140 1100007000 11 Apple, fruit with peel 2.000000 1.000 1.140 1100008000 11 Apple, peeled fruit 2.000000 1.000 1.140 1100008001 11 Apple, peeled fruit-babyfood 2.000000 1.000 1.140 1100009000 11 Apple, dried 2.000000 8.000 1.140 1100009001 11 Apple, dried-babyfood 2.000000 8.000 1.140 1100010000 11 Apple, juice 2.000000 1.300 1.140 Sectio Full comment: Section 18 1100010001 11 Apple, juice-babyfood 2.000000 1.300 1.140 1100011000 11 Apple, sauce 2.000000 1.000 1.140 1100011001 11 Apple, sauce-babyfood 2.000000 1.000 1.140 1100129000 11 Crabapple 2.000000 1.000 1.140 1100173500 11 Goji berry 0.700000 1.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 20 of 25 1100210000 11 Loquat 2.000000 1.000 1.140
1100266000 11 Pear 2.000000 1.000 1.140 1100266001 11 Pear-babyfood 2.000000 1.000 1.140 1100267000 11 Pear, dried 2.000000 6.250 1.140 1100268000 11 Pear, juice 2.000000 1.000 1.140 1100268001 11 Pear, juice-babyfood 2.000000 1.000 1.140 1100310000 11 Quince 2.000000 1.000 1.140 1201090000 12A Cherry 2.000000 1.000 1.140 1201090001 12A Cherry-babyfood 2.000000 1.000 1.140 1201091000 12A Cherry, juice 2.000000 1.500 1.140 1201091001 12A Cherry, juice-babyfood 2.000000 1.500 1.140 1202012000 12B Apricot 2.000000 1.000 1.140 1202012001 12B Apricot-babyfood 2.000000 1.000 1.140 1202013000 12B Apricot, dried 2.000000 6.000 1.140 1202014000 12B Apricot, juice 2.000000 1.000 1.140 1202014001 12B Apricot, juice-babyfood 2.000000 1.000 1.140 1202230000 12B Nectarine 2.000000 1.000 1.140
1202260000 12B Peach 2.000000 1.000 1.140 1202260001 12B Peach-babyfood 2.000000 1.000 1.140 1202261000 12B Peach, dried 2.000000 7.000 1.140 1202261001 12B Peach, dried-babyfood 2.000000 7.000 1.140 1202262000 12B Peach, juice 2.000000 1.000 1.140 1202262001 12B Peach, juice-babyfood 2.000000 1.000 1.140
1203285000 12C Plum 2.000000 1.000 1.140 1203285001 12C Plum-babyfood 2.000000 1.000 1.140 1203286000 12C Plum, prune, fresh 2.000000 1.000 1.140 1203286001 12C Plum, prune, fresh-babyfood 2.000000 1.000 1.140 1203287000 12C Plum, prune, dried 2.000000 5.000 1.140 Sectio Full comment: Section 18 1203287001 12C Plum, prune, dried-babyfood 2.000000 5.000 1.140 1203288000 12C Plum, prune, juice 2.000000 1.400 1.140 1203288001 12C Plum, prune, juice-babyfood 2.000000 1.400 1.140 1301055000 13A Blackberry 0.010000 1.000 1.140 1301056000 13A Blackberry, juice 0.010000 1.000 1.140 1301056001 13A Blackberry, juice-babyfood 0.010000 1.000 1.140 1301058000 13A Boysenberry 0.010000 1.000 1.140 1301208000 13A Loganberry 0.010000 1.000 1.140 1301320000 13A Raspberry 0.010000 1.000 1.140 1301320001 13A Raspberry-babyfood 0.010000 1.000 1.140 1301321000 13A Raspberry, juice 0.010000 1.000 1.140 1301321001 13A Raspberry, juice-babyfood 0.010000 1.000 1.140 1302057000 13B Blueberry 0.200000 1.000 1.140 1302057001 13B Blueberry-babyfood 0.200000 1.000 1.140
1302136000 13B Currant 0.010000 1.000 1.140 1302137000 13B Currant, dried 0.010000 1.000 1.140 1302149000 13B Elderberry 0.010000 1.000 1.140 1302174000 13B Gooseberry 0.900000 1.000 1.140 1302191000 13B Huckleberry 0.010000 1.000 1.140 1303227000 13C Mulberry 0.010000 1.000 1.140 1304175000 13D Grape 0.900000 1.000 1.140 1304176000 13D Grape, juice 0.900000 1.000 1.140 D29019
Full comment: D290191 1304176001 13D Grape, juice-babyfood 0.900000 1.000 1.140 1304179000 13D Grape, wine and sherry 0.900000 1.000 1.140 1304195000 13D Kiwifruit, fuzzy 0.010000 1.000 1.140 1307130000 13G Cranberry 0.200000 1.000 1.140 1307130001 13G Cranberry-babyfood 0.200000 1.000 1.140 1307131000 13G Cranberry, dried 0.200000 1.000 1.140 1307132000 13G Cranberry, juice 0.200000 1.100 1.140 1307132001 13G Cranberry, juice-babyfood 0.200000 1.100 1.140 1307359000 13G Strawberry 0.010000 1.000 1.140 1307359001 13G Strawberry-babyfood 0.010000 1.000 1.140 1307360000 13G Strawberry, juice 0.010000 1.000 1.140 1307360001 13G Strawberry, juice-babyfood 0.010000 1.000 1.140
1400003000 14 Almond 0.010000 1.000 1.140 1400003001 14 Almond-babyfood 0.010000 1.000 1.140 1400004000 14 Almond, oil 0.010000 1.000 1.140 1400004001 14 Almond, oil-babyfood 0.010000 1.000 1.140 1400059000 14 Brazil nut 0.010000 1.000 1.140
1400068000 14 Butternut 0.010000 1.000 1.140
1400081000 14 Cashew 0.010000 1.000 1.140
1400092000 14 Chestnut 0.010000 1.000 1.140
1400155000 14 Hazelnut 0.010000 1.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 21 of 25 1400156000 14 Hazelnut, oil 0.010000 1.000 1.140 1400185000 14 Hickory nut 0.010000 1.000 1.140 1400213000 14 Macadamia nut 0.010000 1.000 1.140
1400269000 14 Pecan 0.010000 1.000 1.140 1400278000 14 Pine nut 0.010000 1.000 1.140 1400282000 14 Pistachio 0.010000 1.000 1.140
1400391000 14 Walnut 0.010000 1.000 1.140 1500025000 15 Barley, pearled barley 0.010000 1.000 1.140 1500025001 15 Barley, pearled barley-babyfood 0.010000 1.000 1.140 1500026000 15 Barley, flour 0.010000 1.000 1.140 1500026001 15 Barley, flour-babyfood 0.010000 1.000 1.140 1500027000 15 Barley, bran 0.010000 1.000 1.140
1500065000 15 Buckwheat 0.010000 1.000 1.140 1500066000 15 Buckwheat, flour 0.010000 1.000 1.140 1500120000 15 Corn, field, flour 0.010000 1.000 1.140 1500120001 15 Corn, field, flour-babyfood 0.010000 1.000 1.140 1500121000 15 Corn, field, meal 0.010000 1.000 1.140 1500121001 15 Corn, field, meal-babyfood 0.010000 1.000 1.140 1500122000 15 Corn, field, bran 0.010000 1.000 1.140 1500123000 15 Corn, field, starch 0.010000 1.000 1.140 1500123001 15 Corn, field, starch-babyfood 0.010000 1.000 1.140 1500124000 15 Corn, field, syrup 0.010000 1.000 1.140 1500124001 15 Corn, field, syrup-babyfood 0.010000 1.000 1.140 1500125000 15 Corn, field, oil 0.010000 1.000 1.140 1500125001 15 Corn, field, oil-babyfood 0.010000 1.000 1.140 1500126000 15 Corn, pop 0.010000 1.000 1.140 1500127000 15 Corn, sweet 0.010000 1.000 1.140 1500127001 15 Corn, sweet-babyfood 0.010000 1.000 1.140 1500226000 15 Millet, grain 0.010000 1.000 1.140 1500231000 15 Oat, bran 0.010000 1.000 1.140 1500232000 15 Oat, flour 0.010000 1.000 1.140 1500232001 15 Oat, flour-babyfood 0.010000 1.000 1.140 1500233000 15 Oat, groats/rolled oats 0.010000 1.000 1.140 1500233001 15 Oat, groats/rolled oats-babyfood 0.010000 1.000 1.140 1500323000 15 Rice, white 9.000000 1.000 1.070 1500323001 15 Rice, white-babyfood 9.000000 1.000 1.070 1500324000 15 Rice, brown 9.000000 1.000 1.070 1500324001 15 Rice, brown-babyfood 9.000000 1.000 1.070 1500325000 15 Rice, flour 9.000000 1.000 1.070 1500325001 15 Rice, flour-babyfood 9.000000 1.000 1.070 1500326000 15 Rice, bran 9.000000 1.000 1.070 1500326001 15 Rice, bran-babyfood 9.000000 1.000 1.070 1500328000 15 Rye, grain 0.010000 1.000 1.140 1500329000 15 Rye, flour 0.010000 1.000 1.140 1500344000 15 Sorghum, grain 0.010000 1.000 1.140 1500345000 15 Sorghum, syrup 0.010000 1.000 1.140 1500381000 15 Triticale, flour 0.010000 1.000 1.140 1500381001 15 Triticale, flour-babyfood 0.010000 1.000 1.140 1500401000 15 Wheat, grain 0.010000 1.000 1.140 1500401001 15 Wheat, grain-babyfood 0.010000 1.000 1.140 1500402000 15 Wheat, flour 0.010000 1.000 1.140 1500402001 15 Wheat, flour-babyfood 0.010000 1.000 1.140 1500403000 15 Wheat, germ 0.010000 1.000 1.140 1500404000 15 Wheat, bran 0.010000 1.000 1.140 1500405000 15 Wild rice 0.010000 1.000 1.140 1800002000 18 Alfalfa, seed 0.010000 1.000 1.140 1901028000 19A Basil, fresh leaves 0.010000 1.000 1.140 1901028001 19A Basil, fresh leaves-babyfood 0.010000 1.000 1.140 1901029000 19A Basil, dried leaves 0.010000 1.000 1.140 1901029001 19A Basil, dried leaves-babyfood 0.010000 1.000 1.140 1901102500 19A Chive, dried leaves 0.010000 1.000 1.140 1901118000 19A Cilantro, leaves 0.010000 1.000 1.140 1901118001 19A Cilantro, leaves-babyfood 0.010000 1.000 1.140 1901144000 19A Dillweed 0.010000 1.000 1.140 1901184000 19A Herbs, other 0.010000 1.000 1.140 1901184001 19A Herbs, other-babyfood 0.010000 1.000 1.140 1901202000 19A Lemongrass 0.010000 1.000 1.140 1901220000 19A Marjoram 0.010000 1.000 1.140 1901220001 19A Marjoram-babyfood 0.010000 1.000 1.140 1901249000 19A Parsley, dried leaves 0.010000 1.000 1.140 1901249001 19A Parsley, dried leaves-babyfood 0.010000 1.000 1.140 1901334000 19A Savory 0.010000 1.000 1.140 1902105000 19B Cinnamon 0.010000 1.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 22 of 25 1902105001 19B Cinnamon-babyfood 0.010000 1.000 1.140 1902119000 19B Coriander, seed 0.010000 1.000 1.140 1902119001 19B Coriander, seed-babyfood 0.010000 1.000 1.140 1902143000 19B Dill, seed 0.010000 1.000 1.140 1902274000 19B Pepper, black and white 0.010000 1.000 1.140 1902274001 19B Pepper, black and white-babyfood 0.010000 1.000 1.140 1902354000 19B Spices, other 0.010000 1.000 1.140 1902354001 19B Spices, other-babyfood 0.010000 1.000 1.140 2001163000 20A Flax seed, oil 0.010000 1.000 1.140 2001319000 20A Rapeseed, oil 0.010000 1.000 1.140 2001319001 20A Rapeseed, oil-babyfood 0.010000 1.000 1.140 2001336000 20A Sesame, seed 0.010000 1.000 1.140 2001336001 20A Sesame, seed-babyfood 0.010000 1.000 1.140 2001337000 20A Sesame, oil 0.010000 1.000 1.140 2001337001 20A Sesame, oil-babyfood 0.010000 1.000 1.140 2002330000 20B Safflower, oil 0.010000 1.000 1.140 2002330001 20B Safflower, oil-babyfood 0.010000 1.000 1.140 2002364000 20B Sunflower, seed 0.010000 1.000 1.140 2002365000 20B Sunflower, oil 0.010000 1.000 1.140 2002365001 20B Sunflower, oil-babyfood 0.010000 1.000 1.140 2003114001 20C Coconut, oil-babyfood 0.010000 1.000 1.140 2003128000 20C Cottonseed, oil 0.400000 1.000 1.070 2003128001 20C Cottonseed, oil-babyfood 0.400000 1.000 1.070
2100228000 21 Mushroom 0.010000 1.000 1.140 3100044000 31 Beef, meat 0.050000 1.000 1.210 3100044001 31 Beef, meat-babyfood 0.050000 1.000 1.210 3100045000 31 Beef, meat, dried 0.050000 1.920 1.210 3100046000 31 Beef, meat byproducts 0.050000 1.000 1.280 3100046001 31 Beef, meat byproducts-babyfood 0.050000 1.000 1.280 3100047000 31 Beef, fat 0.050000 1.000 1.100 3100047001 31 Beef, fat-babyfood 0.050000 1.000 1.100 3100048000 31 Beef, kidney 0.050000 1.000 1.280 3100049000 31 Beef, liver 0.050000 1.000 1.280 3100049001 31 Beef, liver-babyfood 0.050000 1.000 1.280 3200169000 32 Goat, meat 0.050000 1.000 1.210 3200170000 32 Goat, meat byproducts 0.050000 1.000 1.280 3200171000 32 Goat, fat 0.050000 1.000 1.100 3200172000 32 Goat, kidney 0.050000 1.000 1.280 3200173000 32 Goat, liver 0.050000 1.000 1.280 3300189000 33 Horse, meat 0.050000 1.000 1.210 3400290000 34 Pork, meat 0.050000 1.000 1.210 3400290001 34 Pork, meat-babyfood 0.050000 1.000 1.210 3400291000 34 Pork, skin 0.050000 1.000 1.280 3400292000 34 Pork, meat byproducts 0.050000 1.000 1.280 3400292001 34 Pork, meat byproducts-babyfood 0.050000 1.000 1.280 3400293000 34 Pork, fat 0.050000 1.000 1.100 3400293001 34 Pork, fat-babyfood 0.050000 1.000 1.100 3400294000 34 Pork, kidney 0.050000 1.000 1.280 3400295000 34 Pork, liver 0.050000 1.000 1.280 3500339000 35 Sheep, meat 0.050000 1.000 1.210 3500339001 35 Sheep, meat-babyfood 0.050000 1.000 1.210 3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.280 3500341000 35 Sheep, fat 0.050000 1.000 1.100 3500341001 35 Sheep, fat-babyfood 0.050000 1.000 1.100 3500342000 35 Sheep, kidney 0.050000 1.000 1.280 3500343000 35 Sheep, liver 0.050000 1.000 1.280 3600222000 36 Milk, fat 0.050000 1.000 1.160 3600222001 36 Milk, fat-baby food/infant formu 0.050000 1.000 1.160 3600223000 36 Milk, nonfat solids 0.050000 1.000 1.160 3600223001 36 Milk, nonfat solids-baby food/in 0.050000 1.000 1.160 3600224000 36 Milk, water 0.050000 1.000 1.160 3600224001 36 Milk, water-babyfood/infant form 0.050000 1.000 1.160 3600225001 36 Milk, sugar (lactose)-baby food/ 0.050000 1.000 1.160 3800221000 38 Meat, game 0.010000 1.000 1.140 3900312000 39 Rabbit, meat 0.010000 1.000 1.140 4000093000 40 Chicken, meat 0.010000 1.000 1.140 4000093001 40 Chicken, meat-babyfood 0.010000 1.000 1.140 4000094000 40 Chicken, liver 0.010000 1.000 1.060 4000095000 40 Chicken, meat byproducts 0.010000 1.000 1.060 4000095001 40 Chicken, meat byproducts-babyfoo 0.010000 1.000 1.060 4000096000 40 Chicken, fat 0.010000 1.000 1.140 4000096001 40 Chicken, fat-babyfood 0.010000 1.000 1.140 4000097000 40 Chicken, skin 0.010000 1.000 1.060Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 23 of 25 4000097001 40 Chicken, skin-babyfood 0.010000 1.000 1.060 5000382000 50 Turkey, meat 0.010000 1.000 1.140 5000382001 50 Turkey, meat-babyfood 0.010000 1.000 1.140 5000383000 50 Turkey, liver 0.010000 1.000 1.060 5000383001 50 Turkey, liver-babyfood 0.010000 1.000 1.060 5000384000 50 Turkey, meat byproducts 0.010000 1.000 1.060 5000384001 50 Turkey, meat byproducts-babyfood 0.010000 1.000 1.060 5000385000 50 Turkey, fat 0.010000 1.000 1.140 5000385001 50 Turkey, fat-babyfood 0.010000 1.000 1.140 5000386000 50 Turkey, skin 0.010000 1.000 1.060 5000386001 50 Turkey, skin-babyfood 0.010000 1.000 1.060 6000301000 60 Poultry, other, meat 0.010000 1.000 1.140 6000302000 60 Poultry, other, liver 0.010000 1.000 1.060 6000303000 60 Poultry, other, meat byproducts 0.010000 1.000 1.060 6000304000 60 Poultry, other, fat 0.010000 1.000 1.140 6000305000 60 Poultry, other, skin 0.010000 1.000 1.060 7000145000 70 Egg, whole 0.010000 1.000 1.100 7000145001 70 Egg, whole-babyfood 0.010000 1.000 1.100 7000146000 70 Egg, white 0.010000 1.000 1.100 7000146001 70 Egg, white (solids)-babyfood 0.010000 1.000 1.100 7000147000 70 Egg, yolk 0.010000 1.000 1.100 7000147001 70 Egg, yolk-babyfood 0.010000 1.000 1.100 8000157000 80 Fish-freshwater finfish 0.010000 1.000 1.140 8000158000 80 Fish-freshwater finfish, farm ra 0.010000 1.000 1.140 8000159000 80 Fish-saltwater finfish, tuna 0.010000 1.000 1.140 8000160000 80 Fish-saltwater finfish, other 0.010000 1.000 1.140 8000161000 80 Fish-shellfish, crustacean 0.010000 1.000 1.140 8000162000 80 Fish-shellfish, mollusc 0.010000 1.000 1.140 8601000000 86A Water, direct, all sources 0.257000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.257000 1.000 1.000 9500000500 O Acai berry 0.010000 1.000 1.140
9500001000 O Acerola 0.010000 1.000 1.140 9500001500 O Agave 0.010000 1.000 1.140 9500006000 O Amaranth, grain 0.010000 1.000 1.140 9500016000 O Artichoke, globe 0.010000 1.000 1.140 9500019000 O Asparagus 0.010000 1.000 1.140 9500019500 O Atemoya 0.010000 1.000 1.140 9500020000 O Avocado 0.010000 1.000 1.140 9500022000 O Bamboo, shoots 0.010000 1.000 1.140
9500023000 O Banana 0.010000 1.000 1.140 9500023001 O Banana-babyfood 0.010000 1.000 1.140 9500024000 O Banana, dried 0.010000 1.000 1.140 9500024001 O Banana, dried-babyfood 0.010000 1.000 1.140 9500054000 O Belgium endive 0.010000 1.000 1.140 9500060000 O Breadfruit 0.010000 1.000 1.140
9500073000 O Cactus 0.010000 1.000 1.140 9500074000 O Canistel 0.010000 1.000 1.140
9500077000 O Carob 0.010000 1.000 1.140 9500089000 O Cherimoya 0.010000 1.000 1.140 9500109000 O Cocoa bean, chocolate 0.010000 1.000 1.140 9500110000 O Cocoa bean, powder 0.010000 1.000 1.140 9500111000 O Coconut, meat 0.010000 1.000 1.140 9500111001 O Coconut, meat-babyfood 0.010000 1.000 1.140 9500112000 O Coconut, dried 0.010000 1.000 1.140 9500113000 O Coconut, milk 0.010000 1.000 1.140 9500114000 O Coconut, oil 0.010000 1.000 1.140 9500115000 O Coffee, roasted bean 0.010000 1.000 1.140 9500116000 O Coffee, instant 0.010000 1.000 1.140
9500141000 O Date 0.010000 1.000 1.140 9500151000 O Feijoa 0.010000 1.000 1.140 9500153000 O Fig 0.010000 1.000 1.140 9500154000 O Fig, dried 0.010000 1.000 1.140 9500177000 O Grape, leaves 0.900000 1.000 1.140 9500178000 O Grape, raisin 2.500000 1.000 1.140
9500183000 O Guava 0.010000 1.000 1.140 9500183001 O Guava-babyfood 0.010000 1.000 1.140 9500186000 O Honey 0.010000 1.000 1.140 9500186001 O Honey-babyfood 0.010000 1.000 1.140 9500188000 O Hop 0.010000 1.000 1.140 9500193000 O Jackfruit 0.010000 1.000 1.140 9500209000 O Longan 0.010000 1.000 1.140 9500211000 O Lychee 0.010000 1.000 1.140 9500212000 O Lychee, dried 0.010000 1.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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Page 24 of 25 9500214000 O Mamey apple 0.010000 1.000 1.140 9500215000 O Mango 0.010000 1.000 1.140 9500215001 O Mango-babyfood 0.010000 1.000 1.140 9500216000 O Mango, dried 0.010000 1.000 1.140 9500217000 O Mango, juice 0.010000 1.000 1.140 9500217001 O Mango, juice-babyfood 0.010000 1.000 1.140 9500218000 O Maple, sugar 0.010000 1.000 1.140 9500219000 O Maple syrup 0.010000 1.000 1.140 9500235000 O Olive 0.010000 1.000 1.140 9500236000 O Olive, oil 0.010000 1.000 1.140 9500243000 O Palm heart, leaves 0.010000 1.000 1.140 9500244000 O Palm, oil 0.010000 1.000 1.140 9500244001 O Palm, oil-babyfood 0.010000 1.000 1.140 9500245000 O Papaya 0.010000 1.000 1.140 9500245001 O Papaya-babyfood 0.010000 1.000 1.140 9500246000 O Papaya, dried 0.010000 1.000 1.140 9500247000 O Papaya, juice 0.010000 1.000 1.140 9500252000 O Passionfruit 0.010000 1.000 1.140 9500252001 O Passionfruit-babyfood 0.010000 1.000 1.140 9500253000 O Passionfruit, juice 0.010000 1.000 1.140 9500253001 O Passionfruit, juice-babyfood 0.010000 1.000 1.140 9500254000 O Pawpaw 0.010000 1.000 1.140
9500263000 O Peanut 0.010000 1.000 1.140 9500264000 O Peanut, butter 0.010000 1.000 1.140 9500265000 O Peanut, oil 0.010000 1.000 1.140 9500275000 O Peppermint 0.010000 1.000 1.140 9500276000 O Peppermint, oil 0.010000 1.000 1.140 9500277000 O Persimmon 0.010000 1.000 1.140 9500279000 O Pineapple 0.010000 1.000 1.140 9500279001 O Pineapple-babyfood 0.010000 1.000 1.140 9500280000 O Pineapple, dried 0.010000 1.000 1.140 9500281000 O Pineapple, juice 0.010000 1.000 1.140 9500281001 O Pineapple, juice-babyfood 0.010000 1.000 1.140 9500283000 O Plantain 0.010000 1.000 1.140 9500284000 O Plantain, dried 0.010000 1.000 1.140 9500289000 O Pomegranate 0.010000 1.000 1.140 9500306000 O Psyllium, seed 0.010000 1.000 1.140 9500311000 O Quinoa, grain 0.010000 1.000 1.140 9500333000 O Sapote, Mamey 0.010000 1.000 1.140 9500335000 O Seaweed 0.010000 1.000 1.140 9500335001 O Seaweed-babyfood 0.010000 1.000 1.140 9500346000 O Soursop 0.010000 1.000 1.140 9500351000 O Spanish lime 0.010000 1.000 1.140 9500352000 O Spearmint 0.010000 1.000 1.140 9500353000 O Spearmint, oil 0.010000 1.000 1.140 9500358000 O Starfruit 0.010000 1.000 1.140 9500361000 O Sugar apple 0.010000 1.000 1.140 9500362000 O Sugarcane, sugar 0.010000 1.000 1.140 9500362001 O Sugarcane, sugar-babyfood 0.010000 1.000 1.140 9500363000 O Sugarcane, molasses 0.010000 1.000 1.140 9500363001 O Sugarcane, molasses-babyfood 0.010000 1.000 1.140 9500368000 O Tamarind 0.010000 1.000 1.140 9500372000 O Tea, dried 50.000000 1.000 1.140 9500373000 O Tea, instant 50.000000 1.000 1.140 9500373500 O Teff, flour 0.010000 1.000 1.140 9500390000 O Vinegar 0.010000 1.000 1.140
9500397000 O Water chestnut 0.010000 1.000 1.140
9500398000 O Watercress 8.000000 1.000 1.140Dinotefuran Dietary Exposure and Risk Assessment DP Number: D410585 PC Code: 044312

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### Attachment 4: Chronic Results File

U.S. EPA Ver. 3.16, 03-08-d DEEM-FCID Chronic analysis for DINOTEFURAN NHANES 2003-2008 2-day Residue file name: C:\Documents and Settings\NDODD\My Documents\DEEM Version 3.16\Dinotefuran 2013\Dinotefuran chronic 042513.R08 Adjustment factor #2 used. Analysis Date 04-25-2013/10:17:01 Residue file dated: 04-25-2013/10:15:24 Reference dose (RfD, Chronic) = 1 mg/kg bw/day

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

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Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Population 0.016633 1.7% Hispanic 0.018804 1.9% Non-Hisp-White 0.015699 1.6% Non-Hisp-Black 0.016193 1.6% Non-Hisp-Other 0.024558 2.5% Nursing Infants 0.026119 2.6% Non-Nursing Infants 0.057302 5.7%
Female 13+ PREG 0.014557 1.5% Children 1-6 0.042497 4.2% Children 7-12 0.017390 1.7%
Male 13-19 0.010793 1.1% Female 13-19/NP 0.011705 1.2%
Male 20+ 0.013543 1.4% Female 20+/NP 0.013844 1.4% Seniors 55+ 0.013157 1.3%
All Infants 0.047675 4.8%
Female 13-50 0.013418 1.3% Children 1-2 0.056650 5.7% Children 3-5 0.037044 3.7% Children 6-12 0.018991 1.9%
Youth 13-19 0.011261 1.1%
Adults 20-49 0.013944 1.4%
Adults 50-99 0.013404 1.3%
Female 13-49 0.013432 1.3%

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