Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 2 of 17 

### 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 ) w as 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, W hat We Eat in America, (NHANES/ WWEIA) from 2003 through 2008. The analysi s w as 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 hu man health exposure and risk assessment docum ent (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 ; t he most recent dietary risk assessment (J. Redden, D270019 , 8/23/04 ) d id 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 upda ted 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 wat er) 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 ( ED WC ) va l ue w as 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 , t he most highly ex posed p opulation 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 doseTebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 3 of 17 

### (i.e., the dose that HED has concluded will result in no unreasonab le 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 Pesticid es, 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 t ebufenozide 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 c oncern 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

- dim ethylethyl]

- 2

- [4

- [1

- hyd roxyethyl] 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

- methyl

1

- [1,1

- d imethylethyl]

- 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 metab olites (RH

- 112651, RH

- 112703 and RH

- 96595).

Residue Data Used for Chronic Assessments: The analys i s 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 to lerances 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.Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 4 of 17 

### 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 as sessment.

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
crop s 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 RH

96595 for surface water (M. Sahafeyan, D 423156, 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 assessm ent 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 surf ace 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 degrad ates, and a soil sorption coefficient (K OC 

### ) 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 degr adates 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 we re 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 us ed for chronic analysis for all direct and indirect water in DEEM

.Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 5 of 17 Table 1. Tebufenozide Residues in Drinking Water

D rinking W ater S ource (M odel U sed ) U se (rates modeled) M aximum E stimated D rinking W ater C oncentration (EDWC)

A cute ( μg/L ) C hronic ( 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 ( PRZM

GW ) 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 w as 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 translat ion 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 indiv idual 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 gene ral 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 fo od

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form i s 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 perfo rmed for each population subgroup.Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 6 of 17 

### V I . 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. Toxic ological 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 P opulation s ) No appropriate endpoint attributable to a single dose was identified in the toxicity database.

Chronic Dietary ( All P opulations) PoD = 2 mg/kg/day UF A = 10x UF H = 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 UF A = 10x UF H = 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, sple en, 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 %) UF A = 10x UF H = 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 ( O ral, D ermal, I nhalation) Classification : This chemical is classified as “not likely” to be a human carcinogen. A c ancer 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 adver se 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). UF DB = Databa se uncertainty. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). LOC = level of concern. MOE= Margin of exposure.



### VI I . Results and Discussion

For chronic assessments, HED is concerned when dietary risk exceeds 100% of the c PAD. 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 genera l U.S. population, allTebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 7 of 17 

### 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 Analys i s

The resulting chronic expo sure estimates are belo w HED’s level of concern. The most highly exposed population subgroup was children 1

- 2 years old utilizing 37 % of the cPAD (s ee 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 Subgroup 1 Acute Dietary (95 th 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 0.003 704 1 8

N/A N/A All Infants (<1 year old) 0.006852 34 Children 1

- 2 years old 0.007460 3 7 Children 3

- 5 years old 0.005624 2 8 Children 6

- 12 years old 0.003728 1 9 Youth 13

- 19 years old 0.002755 1 4 Adults 20

- 49 years old 0.003466 1 7 Adults 50

- 99 years old 0.003582 1 8 Females 13

- 49 years old 0.003515 1 8

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



### The chronic analys i s assumed tolerance

- level residues, 100% CT, and DEEM (ver. 7.81) default processing factors

. The analys i s 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. Conclusion s

The c hronic dieta ry exposure and risk assessment w as 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 thi s time is not
necessary.

A n acute dietary

- exposure and risk assessment was not conducted because toxic effects attributable to a single exposure to tebufenozide have not been identified

. T here is no evidence that tebufenozide is carcinogenic to humans; t herefore, a cancer dietary exposure assessment is not required.Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 8 of 17 

### 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

_____________________________________________________________________________________________

Page 9 of 17 

### Attachment 1: DEEM

- FCID Chronic Food + Drinking Water Residue Input File.

Filename: C: \ Users \ msahafey \ Documents \ chemicals \ Tebufenozide \ dietary \ TEB

- f+w

5

- 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 modi fied: 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 9 500352000 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 po tato 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 1.0 00 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 1.000Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 10 of 17 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 1.00 0 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 Turni p, 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 10011080 00 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 2.00000 0 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 100220 7001 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 2.00 0000 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 0.010 110 0007000 11 Apple, fruit with peel 1.000000 1.000 0.010 1100010000 11 Apple, juice 1.000000 1.000 0.010Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 11 of 17 1100010001 11 Apple, juice

- babyfood 1.000000 1.000 0.010 1100008000 11 Apple, peele d 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 1 100266000 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, juic e

- 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 Loganbe rry 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 0.02 5 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 Brazi l 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 n ut 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 1.000Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 12 of 17 3100047000 31 Beef, f at 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 1.00 0 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, liv er 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 1.00 0 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 1.000Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 13 of 17 

### 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 (molass es)

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

== 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 0.0068 52 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%

-----------------------------------------------------------------------------Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 14 of 17 

### Attachment 3: SLUATebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 15 of 17Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 16 of 17 /Tebufenozide Dietary Exposure and Risk Assessment DP# 414536

_____________________________________________________________________________________________

Page 17 of 17 

### Attachment 4: H armonized/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 10 1 1) Convert to : Fruit, citrus, group 10

- 10 2) H armonize tolerance 0.80 2.0

Fruit, pome 2 1) Convert to : Fruit,
pome, group 11

- 10 2) H armonize 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, hulls 3 Harmonize tolerance 25 30 Sugarcane, cane 4 Should be established. None 1.0 Sugarcane, molasses 4 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 tol erance 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 tebufen ozide is registered for use on sugarcane. The recommended sugarcane tolerance of 1 .0 ppm harmonize s with Codex.