Tebufenozide Dietary Exposure and Risk Assessment DP# 414536 

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Executive Summary

A chronic aggregate dietary (food and drinking water) exposure and risk assessment for 

tebufenozide (3,5-dimethylbenzoic acid 1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide) was

conducted using the Dietary Exposure Evaluation Model software with the Food Commodity 

Intake Database (DEEM-FCID) Version 3.16, which uses food consumption data from the U.S. 

Department of Agriculture’s National Health and Nutrition Examination Survey, What We Eat in 

America, (NHANES/ WWEIA) from 2003 through 2008. The analysis was performed to 

support a registration review and included recommended changes in tolerances for 

harmonization purposes and crop group conversions which are cited in the HED’s human health 

exposure and risk assessment document (M. Sahafeyan, D414533, 9/9/2015). The dietary risk 

analysis also incorporated drinking water residues directly along with food residues in the same 

analysis as is the current HED policy; the most recent dietary risk assessment (J. Redden, 

D270019, 8/23/04) did not directly incorporate drinking water residues and instead used the 

DWLOC (drinking water level of concern) approach. Furthermore, the residues of concern in 

drinking water is updated since the last dietary risk assessment and includes tebufenozide 

(parent) and degradate(s) instead of parent only. 

This risk assessment has been reviewed by two peer reviewers of the DESAC, per the DESAC 

Standard Operating Procedure (SOP) 2012.1.

Acute Dietary Risk

An acute dietary-exposure and risk assessment was not conducted because toxic effects 

attributable to a single exposure to tebufenozide have not been identified.

Chronic Dietary Risk 

The chronic dietary analysis (food and drinking water) assumed tolerance-level residues for all 

foods, average percent crop treated (% CT), and DEEM 7.81 default concentration factors as 

appropriate. The analysis also includes harmonized/recommended tolerances which are cited in 

the HED’s human health exposure and risk assessment document (M. Sahafeyan, D414533, 

9/9/2015). Dietary risk estimates were determined considering exposures from food plus 

drinking water. The estimated drinking water concentration (EDWC) value was based on 

residues of concern in ground water (107 ppb) from application to fruiting vegetables, mint, and 

ornamentals. The assessment shows that the chronic dietary risk estimates for food plus drinking 

water are below HED’s level of concern [i.e., <100% of the chronic population-adjusted dose 

(cPAD)]. The resulting chronic dietary (food + drinking water) risk estimates utilized 18% of 

the cPAD for the general U.S. population and 37% of the cPAD for children 1-2 years old, the 

most highly exposed population subgroup. 

Cancer 

Tebufenozide is classified as a “Not Likely” carcinogen; therefore, a cancer dietary exposure 

assessment is not required. 

I. Introduction

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

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose 
Tebufenozide Dietary Exposure and Risk Assessment DP# 414536 

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

This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to the 

point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety 

factors.

For non-cancer chronic 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.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2007-0780-0001

The most recent dietary risk assessment for tebufenozide was conducted on 23-AUG-2004 (J. 

Redden, D270019).

II. Residue Information

Tebufenozide is an insecticide and miticide registered for use on a wide range of food and feed 

commodities as well as ornamentals and trees (primarily forestry). Tolerances for tebufenozide 

are under 40 CFR §180.482. Residues of concern for regulatory and risk assessment are as 

follows:

Primary crops: tebufenozide 

Rotational crops: tebufenozide and its metabolite, RH-1788 (benzoic acid, 3,5-dimethyl-1-[1,1-

dimethylethyl]-2-[4-[1-hydroxyethyl] benzoyl] hydrazide). Note: all the rotational crops under 

40 CFR §180.482 are feed commodities at present.

Livestock commodities: tebufenozide and the four metabolites designated RH-2703 (benzoic 

acid, 3,5-dimethyl-1-[1,1-dimethylethyl]-2-[[4-carboxymethyl] benzoyl]hydrazide), RH-9886 

(benzoic acid, 3-hydroxymethyl-5-methyl-1-[1,1-dimethylethyl]-2-[4-ethylbenzoyl]hydrazide), 

the stearic acid conjugate of RH-9886, and RH-0282 (benzoic acid, 3-hydroxymethyl-5-methyl1-[1,1-dimethylethyl]-2-[4-[1-hydroxyethyl] benzoyl]hydrazide). 

Drinking Water: (see memorandum from M. Sahafeyan, DP 423156, 10/2/2014)

• For ground water: tebufenozide and metabolite RH-112651; this is the major route of 

concern for drinking water at present.

• For surface waters: tebufenozide and the 3 metabolites, RH-112651, RH-112703, and 

RH-96595.

Note: EFED has included the parent and three degradates in the groundwater assessment. A 

Total Toxic Residues (TTR) approach was employed to model both ground and surface water, in 

which TTR comprises parent tebufenozide plus all three of its major metabolites (RH-112651, 

RH-112703 and RH-96595). 

Residue Data Used for Chronic Assessments: The analysis utilized established tolerance-level 

residues for all commodities including harmonized/recommended tolerances which are cited in 

the HED’s human health exposure and risk assessment (M. Sahafeyan, D414533, 9/9/2015); see 

attachment 4. The recommended harmonized tolerances for citrus fruit and pome fruit are 2.0 

ppm and 1.0 ppm respectively. HED also noted that tolerances for sugarcane and molasses 

should be established based on HED recommendation in 1999. This analysis also incorporated 

DEEM (ver. 7.81) default processing factors where applicable.
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Residues in Fish: The USDA Pesticide Data Program (PDP) monitored pesticide residues in 

catfish in 2008, 2009, and 2010. Over this 3-year period, PDP analyzed 1479 samples of catfish 

for tebufenozide residues. None of the samples contained detectable residues. As a result, 

residues in fish were not included in the assessment.

III. Percent Crop Treated

The following average percent crop treated estimates (from screening level usage analysis, 

SLUA, provided by BEAD for 2014) were used in the chronic dietary risk assessment for the 

following crops: blueberries: 10%; cabbage, caneberries, cauliflower, celery, lettuce, parsley, 

pecans, peppers, tomatoes and walnuts: each at 5%; almonds, broccoli, pistachios, spinach, and 

turnip roots: each at 2.5%; apples, cotton, grapes and pears: each at 1%. For other registered 

crops not listed in the SLUA report except orange, 100% CT were assumed; for orange and its 

related commodities, the primary analysis showed that orange input parameters in the dietary 

exposure model needed to be refined since it was the major contributor to the dietary risk. HED, 

in coordination with BEAD (e-mail communication with Don Atwood in BEAD, 9/22/2014), 

used 1% CT, for orange and its related commodities in the dietary analysis. 

IV. Drinking Water Data

The residues of concern in drinking water was recently updated to include parent and metabolite 

RH-112651 for ground water and parent plus 3 metabolites, RH-112651, RH-112703, and RH96595 for surface water (M. Sahafeyan, D423156, 10/2/2014). However, the Environmental 

Fate and Effect Division (EFED), used the Total Toxic Residues (TTR) approach, assuming 

presence of parent tebufenozide plus all three of its major metabolites, RH-112651, RH-112703 

and RH-9659 in both ground and surface water in its assessment of tebufenozide residues in 

drinking water (J. N. Carleton, D423306, 2/10/15). Since this approach is likely to overestimate 

residues in water, further revision of the estimates to reflect the specific metabolites of concern is 

not required.

In surface water TTR was conservatively modeled as a single conceptual entity with Surface 

Water Concentration Calculator (SWCC) and with the Provisional Cranberry Model, using an 

aerobic soil half-life representing the degradation of parent plus all three degradates, and a soil 

sorption coefficient (KOC) reflecting one of the (more mobile than parent) degradates, for which 

data were available. Unlike surface water, groundwater modeling (using PRZM-GW) was 

“refined,” by simulating parent and the three summed degradates as separate entities, then 

combining their resulting EDWCs to represent TTR. 

Table below contains results of the EFED’s maximum estimated drinking water concentration 

(EDWCs) for different use cites and application rates. The EDWCs values which were 

recommended for use in the human health dietary risk assessment are 116.4 μg/L for acute 

EDWC and 107.2 ug/L for chronic and cancer EDWCs. As there is not an acute toxic end point 

for tebufenozide, the maximum 107 ppb (0.107 ppm) modeled from fruiting vegetables, mint and 

ornamentals in Pesticide Root Zone Model for Groundwater (PRZM-GW) model was used for 

chronic analysis for all direct and indirect water in DEEM.
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Table 1. Tebufenozide Residues in Drinking Water

Drinking Water

Source (Model Used)

Use (rates 

modeled)

Maximum Estimated Drinking Water Concentration

(EDWC) 

Acute (μg/L) Chronic (μg/L) Cancer (μg/L)

Surface water

(SWCC; 

LAsugarcaneSTD 

scenario, ground 

application for acute; 

FLpeppersSTD

scenario, ground 

application for chronic 

and cancer)

Sugarcane (4 apps at 

0.25 lbs a.i./A, 10 

day RTI); fruiting 

vegetables (8 apps at 

0.25 lbs a.i./A, 10 

day RTI)

51.8 3.13 2.19

Surface water

(Provisional Cranberry 

Model)

Cranberries

(4 apps at 0.25 lbs

a.i./A, 7 day RTI)

279.3 105.8  ̄

Groundwater (PRZMGW)

Fruiting vegetables, 

mint, ornamentals 

(WI sands) 

(2.0 lb a.i./A/yr: 8 

apps at 0.25 lbs 

a.i./A, 10 day RTI)

116.4 107.2 107.2

V. DEEM-FCID Program and Consumption Information

The tebufenozide chronic dietary exposure assessment was conducted using DEEM-FCID, 

Version 3.16, which incorporates consumption data from USDA’s NHANES/WWEIA from 

2003 through 2008. The data are based on the reported consumption of more than 20,000 

individuals over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are 

linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; 

or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files 

developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data 

are averaged for the entire U.S. population and within population subgroups. However, for acute 

exposure assessment, consumption data are retained as individual consumption events. Based on 

analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns 

and survey respondents, HED concluded that it is most appropriate to report risk for the 

following population subgroups: the general U.S. population, all infants (<1 year old), children 

1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 

years old.

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup.
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VI. Toxicological Information

Table 2 summarizes the toxicological doses and endpoints for tebufenozide concerning dietary 

exposure assessment. The endpoints have been reviewed by the risk assessment team and are 

considered appropriate for the current risk assessment. 

 Table 2. Toxicological Doses and Endpoints for Use in Tebufenozide Human Health 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

(All Populations)

No appropriate endpoint attributable to a single dose was identified in the toxicity database.

Chronic Dietary

(All Populations)

PoD = 2 mg/kg/day

UFA = 10x

UFH = 10x

FQPA SF = 1x

cRfD = 0.02

cPAD = 0.02 

mg/kg/day

MRID# 42436223, 42931203, 

42931204

90- Day Dog and 1-Year Dog Study 

(co-critical), LOAEL=8.7 mg/kg/day 

based on decreases in body weight 

gains, alterations in hematology 

parameters, changes in organ weights, 

and histopathological lesions in the 

bone, spleen, and liver.

Incidental Oral-

(Short-term)

PoD= 2.0 mg/kg/day

UFA = 10x

UFH = 10x

FQPA SF = 1x

Residental LOC 

for MOE =100

MRID# 42436223, 42931203, 

42931204

90- Day Dog and 1-Year Dog Study 

(co-critical), LOAEL=8.7 mg/kg/day 

based on decreases in body weight 

gains, alterations in hematology 

parameters, changes in organ weights, 

and histopathological lesions in the 

bone, spleen, and liver.

Dermal 

(All time period)

No dermal endpoint was selected based on a lack of systemic toxicity in the dermal study 

and no concern for susceptibility.

Inhalation 

(All time period)

Oral, PoD= 2.0 mg/kg/day

(inhalation toxicity assumed 

to be equivalent to oral 

toxicity 100%)

UFA = 10x

UFH = 10x

Occupational 

LOC for 

MOE = 100

MRID# 42436223, 42931203, 

42931204

90- Day Dog and 1-Year Dog Study 

(co-critical), LOAEL=8.7 mg/kg/day 

based on decreases in body weight 

gains, alterations in hematology 

parameters, changes in organ weights, 

and histopathological lesions in the 

bone, spleen, and liver.

Cancer (Oral, 

Dermal, Inhalation)

Classification: This chemical is classified as “not likely” to be a human carcinogen.

A cancer risk assessment is not required.

Point of Departure (POD) = data point or estimated point, derived from observed dose-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. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). UFDB= Database uncertainty. FQPA SF = 

FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). LOC = level of concern. MOE= 

Margin of exposure.

VII. Results and Discussion

For chronic assessments, HED is concerned when dietary risk exceeds 100% of the cPAD. The 

DEEM-FCID analyses estimate the dietary exposure of the general U.S. population and various 

population subgroups. The results reported in Table 3 are for the general U.S. population, all 
Tebufenozide Dietary Exposure and Risk Assessment DP# 414536 

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infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, 

adults 20-49, and adults 50-99 years old. 

Results of Chronic Dietary Exposure Analysis

The resulting chronic exposure estimates are below HED’s level of concern. The most highly 

exposed population subgroup was children 1-2 years old utilizing 37% of the cPAD (see Table 3

below for a summary of the results). A chronic cancer dietary assessment was not conducted 

since it was determined that tebufenozide is not likely to be a human carcinogen.

Table 3. Summary of Dietary (Food + Drinking Water) Exposure and Risk for Tebufenozide.

Population Subgroup1

Acute Dietary

(95th Percentile) Chronic Dietary Cancer

Dietary

Exposure 

(mg/kg/day)

% aPAD

Dietary 

Exposure

(mg/kg/day)

% cPAD

Dietary 

Exposure

(mg/kg/day)

Risk

General U.S. Population

N/A N/A

0.003704 18

N/A N/A

All Infants (<1 year old) 0.006852 34

Children 1-2 years old 0.007460 37

Children 3-5 years old 0.005624 28

Children 6-12 years old 0.003728 19

Youth 13-19 years old 0.002755 14

Adults 20-49 years old 0.003466 17

Adults 50-99 years old 0.003582 18

Females 13-49 years old 0.003515 18 1

 The value for the highest exposed population subgroup for the chronic assessment is bolded.

The chronic analysis assumed tolerance-level residues, 100% CT, and DEEM (ver. 7.81) default 

processing factors. The analysis is considered very conservative and could be refined using

anticipated-residue estimates (ARs), percent market share data, and/or empirical processing 

factors. However, at this time refinement is not necessary.

VIII. Conclusions

The chronic dietary exposure and risk assessment was conducted using DEEM-FCID, Version 

3.16, which incorporates consumption data from USDA’s NHANES/WWEIA from 2003 

through 2008. The chronic analysis assumed tolerance-level residues, 100% CT, DEEM (ver. 

7.81) default processing factors, as well as drinking water estimates provided by EFED. The 

resulting chronic risk estimates are not of concern to HED. The most highly exposed population

subgroup was children 1-2 years old utilizing 37% of the cPAD. Refinement at this time is not 

necessary.

An acute dietary-exposure and risk assessment was not conducted because toxic effects 

attributable to a single exposure to tebufenozide have not been identified. There is no evidence 

that tebufenozide is carcinogenic to humans; therefore, a cancer dietary exposure assessment is 

not required. 
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Attachments

Attachment 1: DEEM-FCID Chronic Food + Drinking Water Residue Input File.

Attachment 2: DEEM-FCID Chronic Exposure Estimates.

Attachment 3: SLUA (Aug. 2014)
Tebufenozide Dietary Exposure and Risk Assessment DP# 414536 

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Attachment 1: DEEM-FCID Chronic Food + Drinking Water Residue Input File.

Filename: C:\Users\msahafey\Documents\chemicals\Tebufenozide\dietary\TEB-f+w5-28-15-Wtr-p107-recomTol.R08

Chemical: Tebufenozide

RfD(Chronic): .02 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 05-28-2015/15:48:25 Program ver. 3.16, 03-08-d

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

------

 EPA Crop Def Res Adj.Factors 

Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

------

9500177000 O Grape, leaves 3.000000 1.000 0.010 

9500178000 O Grape, raisin 3.000000 4.300 0.010 

9500275000 O Peppermint 10.000000 1.000 1.000 

9500276000 O Peppermint, oil 10.000000 1.000 1.000 

9500352000 O Spearmint 10.000000 1.000 1.000 

9500353000 O Spearmint, oil 10.000000 1.000 1.000 

9500363000 O Sugarcane, molasses 3.000000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 3.000000 1.000 1.000 

0103015000 1CD Arrowroot, flour 0.015000 1.000 1.000 

0103015001 1CD Arrowroot, flour-babyfood 0.015000 1.000 1.000 

0103017000 1CD Artichoke, Jerusalem 0.015000 1.000 1.000 

0103082000 1CD Cassava 0.015000 1.000 1.000 

0103082001 1CD Cassava-babyfood 0.015000 1.000 1.000 

0103139000 1CD Dasheen, corm 0.015000 1.000 1.000 

0103166000 1CD Ginger 0.015000 1.000 1.000 

0103167000 1CD Ginger, dried 0.015000 1.000 1.000 

0103166001 1CD Ginger-babyfood 0.015000 1.000 1.000 

0103366000 1CD Sweet potato 0.015000 1.000 1.000 

0103366001 1CD Sweet potato-babyfood 0.015000 1.000 1.000 

0103371000 1CD Tanier, corm 0.015000 1.000 1.000 

0103387000 1CD Turmeric 0.015000 1.000 1.000 

0101388000 1AB Turnip, roots 0.300000 1.000 0.025 

0103407000 1CD Yam bean 0.015000 1.000 1.000 

0103406000 1CD Yam, true 0.015000 1.000 1.000 

0401005000 4A Amaranth, leafy 10.000000 1.000 1.000 

0401018000 4A Arugula 10.000000 1.000 1.000 

0402076000 4B Cardoon 2.000000 1.000 1.000 

0402085000 4B Celery 2.000000 1.000 0.050 

0402086000 4B Celery, juice 2.000000 1.000 0.050 

0402085001 4B Celery-babyfood 2.000000 1.000 0.050 

0402087000 4B Celtuce 2.000000 1.000 1.000 

0401104000 4A Chrysanthemum, garland 10.000000 1.000 1.000 

0401133000 4A Cress, garden 10.000000 1.000 1.000 

0401134000 4A Cress, upland 10.000000 1.000 1.000 

0401138000 4A Dandelion, leaves 10.000000 1.000 1.000 

0401150000 4A Endive 10.000000 1.000 1.000 

0402152000 4B Fennel, Florence 2.000000 1.000 1.000 

0401204000 4A Lettuce, head 10.000000 1.000 0.050 

0401205000 4A Lettuce, leaf 10.000000 1.000 0.050 

0401248000 4A Parsley, leaves 10.000000 1.000 0.050 

0401313000 4A Radicchio 10.000000 1.000 1.000 

0402322000 4B Rhubarb 2.000000 1.000 1.000 

0401355000 4A Spinach 10.000000 1.000 0.025 

0401355001 4A Spinach-babyfood 10.000000 1.000 0.025 

0402367000 4B Swiss chard 2.000000 1.000 1.000 
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0501061000 5A Broccoli 5.000000 1.000 0.025 

0502063000 5B Broccoli raab 10.000000 1.000 1.000 

0501062000 5A Broccoli, Chinese 5.000000 1.000 1.000 

0501061001 5A Broccoli-babyfood 5.000000 1.000 0.025 

0501064000 5A Brussels sprouts 5.000000 1.000 1.000 

0501069000 5A Cabbage 5.000000 1.000 0.050 

0502070000 5B Cabbage, Chinese, bok choy 10.000000 1.000 1.000 

0501072000 5A Cabbage, Chinese, mustard 5.000000 1.000 1.000 

0501071000 5A Cabbage, Chinese, napa 5.000000 1.000 1.000 

0501083000 5A Cauliflower 5.000000 1.000 0.050 

0502117000 5B Collards 10.000000 1.000 1.000 

0502194000 5B Kale 10.000000 1.000 1.000 

0501196000 5A Kohlrabi 5.000000 1.000 1.000 

0502229000 5B Mustard greens 10.000000 1.000 1.000 

0502318000 5B Rape greens 10.000000 1.000 1.000 

0502389000 5B Turnip, greens 9.000000 1.000 1.000 

0802148000 8BC Eggplant 1.000000 1.000 1.000 

0802234000 8BC Okra 1.000000 1.000 1.000 

0802270000 8B Pepper, bell 1.000000 1.000 0.050 

0802271000 8B Pepper, bell, dried 1.000000 1.000 0.050 

0802271001 8B Pepper, bell, dried-babyfood 1.000000 1.000 0.050 

0802270001 8B Pepper, bell-babyfood 1.000000 1.000 0.050 

0802272000 8BC Pepper, nonbell 1.000000 1.000 0.050 

0802273000 8BC Pepper, nonbell, dried 1.000000 1.000 0.050 

0802272001 8BC Pepper, nonbell-babyfood 1.000000 1.000 0.050 

0801374000 8A Tomatillo 1.000000 1.000 1.000 

0801375000 8A Tomato 1.000000 1.000 0.050 

0801380000 8A Tomato, Tree 1.000000 1.000 1.000 

0801378000 8A Tomato, dried 1.000000 14.300 0.050 

0801378001 8A Tomato, dried-babyfood 1.000000 14.300 0.050 

0801379000 8A Tomato, juice 1.000000 1.500 0.050 

0801376000 8A Tomato, paste 1.000000 1.000 0.050 

0801376001 8A Tomato, paste-babyfood 1.000000 1.000 0.050 

0801377000 8A Tomato, puree 1.000000 1.000 0.050 

0801377001 8A Tomato, puree-babyfood 1.000000 1.000 0.050 

0801375001 8A Tomato-babyfood 1.000000 1.000 0.050 

1001106000 10A Citron 2.000000 1.000 1.000 

1001107000 10A Citrus hybrids 2.000000 1.000 1.000 

1001108000 10A Citrus, oil 15.000000 1.000 1.000 

1003180000 10C Grapefruit 2.000000 1.000 1.000 

1003181000 10C Grapefruit, juice 2.000000 1.000 1.000 

1002197000 10B Kumquat 2.000000 1.000 1.000 

1002199000 10B Lemon 2.000000 1.000 1.000 

1002200000 10B Lemon, juice 2.000000 1.000 1.000 

1002200001 10B Lemon, juice-babyfood 2.000000 1.000 1.000 

1002201000 10B Lemon, peel 2.000000 1.000 1.000 

1002206000 10B Lime 2.000000 1.000 1.000 

1002207000 10B Lime, juice 2.000000 1.000 1.000 

1002207001 10B Lime, juice-babyfood 2.000000 1.000 1.000 

1001240000 10A Orange 2.000000 1.000 0.010 

1001241000 10A Orange, juice 2.000000 1.000 0.010 

1001241001 10A Orange, juice-babyfood 2.000000 1.000 0.010 

1001242000 10A Orange, peel 2.000000 1.000 0.010 

1003307000 10C Pummelo 2.000000 1.000 1.000 

1001369000 10A Tangerine 2.000000 1.000 1.000 

1001370000 10A Tangerine, juice 2.000000 1.000 1.000 

1100009000 11 Apple, dried 1.000000 8.000 0.010 

1100009001 11 Apple, dried-babyfood 1.000000 8.000 0.010 

1100007000 11 Apple, fruit with peel 1.000000 1.000 0.010 

1100010000 11 Apple, juice 1.000000 1.000 0.010 
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1100010001 11 Apple, juice-babyfood 1.000000 1.000 0.010 

1100008000 11 Apple, peeled fruit 1.000000 1.000 0.010 

1100008001 11 Apple, peeled fruit-babyfood 1.000000 1.000 0.010 

1100011000 11 Apple, sauce 1.000000 1.000 0.010 

1100011001 11 Apple, sauce-babyfood 1.000000 1.000 0.010 

1100129000 11 Crabapple 1.000000 1.000 1.000 

1100173500 11 Goji berry 1.000000 1.000 1.000 

1100210000 11 Loquat 1.000000 1.000 1.000 

1100266000 11 Pear 1.000000 1.000 0.010 

1100267000 11 Pear, dried 1.000000 6.250 0.010 

1100268000 11 Pear, juice 1.000000 1.000 0.010 

1100268001 11 Pear, juice-babyfood 1.000000 1.000 0.010 

1100266001 11 Pear-babyfood 1.000000 1.000 0.010 

1100310000 11 Quince 1.000000 1.000 1.000 

1301055000 13A Blackberry 3.000000 1.000 0.050 

1301056000 13A Blackberry, juice 3.000000 1.000 0.050 

1301056001 13A Blackberry, juice-babyfood 3.000000 1.000 0.050 

1302057000 13B Blueberry 3.000000 1.000 0.100 

1302057001 13B Blueberry-babyfood 3.000000 1.000 0.100 

1301058000 13A Boysenberry 3.000000 1.000 0.050 

1307130000 13G Cranberry 1.000000 1.000 1.000 

1307131000 13G Cranberry, dried 1.000000 1.000 1.000 

1307132000 13G Cranberry, juice 1.000000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 1.000000 1.100 1.000 

1307130001 13G Cranberry-babyfood 1.000000 1.000 1.000 

1302136000 13B Currant 3.000000 1.000 1.000 

1302137000 13B Currant, dried 3.000000 1.000 1.000 

1302149000 13B Elderberry 3.000000 1.000 1.000 

1302174000 13B Gooseberry 3.000000 1.000 1.000 

1304175000 13D Grape 3.000000 1.000 0.010 

1304176000 13D Grape, juice 3.000000 1.000 0.010 

1304176001 13D Grape, juice-babyfood 3.000000 1.000 0.010 

1304179000 13D Grape, wine and sherry 3.000000 1.000 0.010 

1302191000 13B Huckleberry 3.000000 1.000 1.000 

1301208000 13A Loganberry 3.000000 1.000 0.050 

1303227000 13C Mulberry 3.000000 1.000 1.000 

1301320000 13A Raspberry 3.000000 1.000 0.050 

1301321000 13A Raspberry, juice 3.000000 1.000 0.050 

1301321001 13A Raspberry, juice-babyfood 3.000000 1.000 0.050 

1301320001 13A Raspberry-babyfood 3.000000 1.000 0.050 

1400003000 14 Almond 0.100000 1.000 0.025 

1400004000 14 Almond, oil 0.100000 1.000 0.025 

1400004001 14 Almond, oil-babyfood 0.100000 1.000 0.025 

1400003001 14 Almond-babyfood 0.100000 1.000 0.025 

1400059000 14 Brazil nut 0.100000 1.000 1.000 

1400068000 14 Butternut 0.100000 1.000 1.000 

1400081000 14 Cashew 0.100000 1.000 1.000 

1400092000 14 Chestnut 0.100000 1.000 1.000 

1400155000 14 Hazelnut 0.100000 1.000 1.000 

1400156000 14 Hazelnut, oil 0.100000 1.000 1.000 

1400185000 14 Hickory nut 0.100000 1.000 1.000 

1400213000 14 Macadamia nut 0.100000 1.000 1.000 

1400269000 14 Pecan 0.100000 1.000 0.050 

1400278000 14 Pine nut 0.100000 1.000 1.000 

1400282000 14 Pistachio 0.100000 1.000 0.025 

1400391000 14 Walnut 0.100000 1.000 0.050 

2003128000 20C Cottonseed, oil 1.500000 1.000 0.010 

2003128001 20C Cottonseed, oil-babyfood 1.500000 1.000 0.010 

2001319000 20A Rapeseed, oil 4.000000 1.000 1.000 

2001319001 20A Rapeseed, oil-babyfood 4.000000 1.000 1.000 
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3100047000 31 Beef, fat 0.100000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.100000 1.000 1.000 

3100048000 31 Beef, kidney 0.080000 1.000 1.000 

3100049000 31 Beef, liver 0.080000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 0.080000 1.000 1.000 

3100044000 31 Beef, meat 0.080000 1.000 1.000 

3100046000 31 Beef, meat byproducts 0.080000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.080000 1.000 1.000 

3100045000 31 Beef, meat, dried 0.080000 1.920 1.000 

3100044001 31 Beef, meat-babyfood 0.080000 1.000 1.000 

3200171000 32 Goat, fat 0.100000 1.000 1.000 

3200172000 32 Goat, kidney 0.080000 1.000 1.000 

3200173000 32 Goat, liver 0.080000 1.000 1.000 

3200169000 32 Goat, meat 0.080000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.080000 1.000 1.000 

3300189000 33 Horse, meat 0.080000 1.000 1.000 

3400293000 34 Pork, fat 0.100000 1.000 1.000 

3400293001 34 Pork, fat-babyfood 0.100000 1.000 1.000 

3400294000 34 Pork, kidney 0.080000 1.000 1.000 

3400295000 34 Pork, liver 0.080000 1.000 1.000 

3400290000 34 Pork, meat 0.080000 1.000 1.000 

3400292000 34 Pork, meat byproducts 0.080000 1.000 1.000 

3400292001 34 Pork, meat byproducts-babyfood 0.080000 1.000 1.000 

3400290001 34 Pork, meat-babyfood 0.080000 1.000 1.000 

3400291000 34 Pork, skin 0.080000 1.000 1.000 

3500341000 35 Sheep, fat 0.100000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.100000 1.000 1.000 

3500342000 35 Sheep, kidney 0.080000 1.000 1.000 

3500343000 35 Sheep, liver 0.080000 1.000 1.000 

3500339000 35 Sheep, meat 0.080000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.080000 1.000 1.000 

3500339001 35 Sheep, meat-babyfood 0.080000 1.000 1.000 

3600222000 36 Milk, fat 0.040000 1.000 1.000 

3600222001 36 Milk, fat-baby food/infant formu 0.040000 1.000 1.000 

3600223000 36 Milk, nonfat solids 0.040000 1.000 1.000 

3600223001 36 Milk, nonfat solids-baby food/in 0.040000 1.000 1.000 

3600225001 36 Milk, sugar (lactose)-baby food/ 0.040000 1.000 1.000 

3600224000 36 Milk, water 0.040000 1.000 1.000 

3600224001 36 Milk, water-babyfood/infant form 0.040000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.107000 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.107000 1.000 1.000 
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Attachment 2: DEEM-FCID Chronic Exposure Estimates.

Company Name Ver. 3.16, 03-08-d

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

Residue file name: 

C:\Users\msahafey\Documents\chemicals\Tebufenozide\dietary\TEB-f+w-5-28-15-

Wtr-p107-recomTol.R08

 Adjustment factor #2 used.

Analysis Date 05-28-2015/15:50:57 Residue file dated: 05-28-2015/15:48:25

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

COMMENT 1: Includes converted crop groups, harmonzied tolerances and 

sugarcane food commodity (molasses)

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

==

 Total exposure by population subgroup

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

--

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.003704 18.5%

Hispanic 0.003528 17.6%

Non-Hisp-White 0.003663 18.3%

Non-Hisp-Black 0.003849 19.2%

Non-Hisp-Other 0.004383 21.9%

Nursing Infants 0.002508 12.5%

Non-Nursing Infants 0.008792 44.0%

Female 13+ PREG 0.003632 18.2%

Children 1-6 0.006187 30.9%

Children 7-12 0.003490 17.4%

Male 13-19 0.002674 13.4%

Female 13-19/NP 0.002838 14.2%

Male 20+ 0.003281 16.4%

Female 20+/NP 0.003723 18.6%

Seniors 55+ 0.003493 17.5%

All Infants 0.006852 34.3%

Female 13-50 0.003522 17.6%

Children 1-2 0.007460 37.3%

Children 3-5 0.005624 28.1%

Children 6-12 0.003728 18.6%

Youth 13-19 0.002755 13.8%

Adults 20-49 0.003466 17.3%

Adults 50-99 0.003582 17.9%

Female 13-49 0.003515 17.6%

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Attachment 3: SLUA
Tebufenozide Dietary Exposure and Risk Assessment DP# 414536 

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Tebufenozide Dietary Exposure and Risk Assessment DP# 414536 

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Tebufenozide Dietary Exposure and Risk Assessment DP# 414536 

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Attachment 4: Harmonized/Recommended Tolerances

(Reference: M. Sahafeyan, “Tebufenozide: Human Health Risk Assessment for Registration 

Review”, D414533, 9/9/2015)

Table A4 Commodity/Tolerance Updates

Commodity Action Established Tolerance Recommended/harmonized 

Tolerance

Berry group 13 Convert to: Caneberry 

Subgroup 13-07A

And 

Bushberry subgroup 

13-07B

3.0 3.0

Fruit, citrus, group 101 1) Convert to: Fruit, 

citrus, group 10-10

2) Harmonize 

tolerance

0.80 2.0

Fruit, pome2 1) Convert to: Fruit, 

pome, group 11-10

2) Harmonize 

tolerance

1.5 1.0

Nut, tree, group 14 Convert to: Nut, tree, 

group 14-12

0.1 0.1

Vegetable, fruiting, 

group 8

Convert to: Vegetable, 

fruiting, group 8-10

1.0 1.0

Pistachio Revoke tolerance as it 

is included in the crop 

group 14-12

0.1 Revoke

Walnut Revoke tolerance as it 

is included in the crop 

group

14-12

0.1 Revoke

Apple Revoke tolerance as it 

is included in crop 

group 11-10

1.0 Revoke

Kiwifruit Revoke tolerance since 

US registration expired 

June 15, 1999

0.5 Revoke

Almond, hulls3 Harmonize tolerance 25 30

Sugarcane, cane4 Should be established. None 1.0

Sugarcane, molasses4 Should be established. None 3.0 1 Tolerance for fruit, citrus, group 10-10 is recommended to be changed from 0.80 ppm to 2.0 ppm to harmonize with Codex. 2 Tolerance for fruit, pome, group 11-10 is recommended to be changed from 1.5 ppm to 1.0 to harmonize with Codex. 3 Tolerance for almond hulls is recommended to be changed from 25 ppm to 30 to harmonize with Codex. The increase in 

almond hulls tolerance is not expected to change the livestock dietary burden significantly; i.e., livestock tolerances are not 

changed.

4 HED recommended tolerances for sugarcane (1.0 ppm) and molasses (3.0 ppm) previously (Yan Donovan, D239395, 6/21/99)

because tebufenozide is registered for use on sugarcane. The recommended sugarcane tolerance of 1.0 ppm harmonizes with 

Codex.