### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 2 of 49 Executive Summary

A cute and chronic dietary exposure and risk assessments were conducted for buprofezin using the Dietary Exposure Evaluation Model

- Food Consumption Intake Database (DEEM

- FCID

, ver. 2.03). DEEM

- FCID incorporates food consumption data from the United Stat es Department of Agriculture (USDA) Continuing Surveys of Food Intakes by Individuals (CSFII;

1994

- 1996 and 1998). Th is assessment is being conducted in support of new or expanded use s of buprofezin on tree nuts ( i ncluding p ist a chio ); succulent beans; Bra ssica, leafy greens

, crop

s ubgroup 5B; t urnip greens; fruiting vegetables, crop group 8

- 10; citrus fruit, crop group 1 0

- 10; pome fruit, crop group 1 1

- 10; p ersimmon; and t ea (no U.S. registration)

.

Acute Dietary and Drinking Water Exposure Results and Characterization

A screening level acute dietary analysis was conducted for this assessment assuming 100% crop

treated for all commodities

. Total residue s of concern in crop commodities (i.e., buprofezin and

the BF4 Conjugate which is not detectable by data collection methods but which may be estimated

from metabolism data) were based on tolerance level residues of buprofezin and available

metabolism

/magnitude of the residue data to estimate other residues of concern

. Given the potential for BF9 and BF12 to concentrate to a greater degree than buprofezin in processed
commodities, DEEM default processing factors were retained for all commodities , except for tomato paste and puree

, which were reduced based on empirical data. Based on the su bmitted
lemon metabolism data, which indicated that re sidues of concern are primarily found in/on the peel, the maximum theoretical concentration factor for peel was used to estimate residues of concern in citrus peel. Total residues of concern in m eat ( i .e., buprofezin and BF 2 ) and milk ( i.e., buprofezin and BF 23 ) were based on the f eeding study data which were used to establish meat and

milk tolerances

. Based on the submitted data

, which indicated a 5x concentration of residues into

milk cream and fat and a Log K

ow 

## of 4.31, a default 25x concentration factor was applied to milk

fat

. The acute analysis also incorporated the 1 in 10 year peak surface drinking water estimate resulting from application of buprofezin to coffee. The re sulting acute exposure estimate for

females 13

- 49 years old is not of concern to HED ( 5 % acute population adjustment dose (aPAD)). No acute endpoint was identified for the remaining population subgroups.

Chronic Dietary and Drinking Water Exposure Results and Characterization

A refined chronic dietary analysis was conducted for this assessment using percent crop treated

estimates when available

. Total residues of concern in crop commodities (i.e., buprofezin an d the

BF4 Conjugate which is not detectable by data collection methods but which may be estimated from metabolism data) were based on average field trial, average USDA Pesticide Data Program (PDP) , or tolerance level r esidues to estimate anticipated residues of buprofezin and available

metabolism

/magnitude of the residue data to estimate other residues of concern. Given the potential for BF9 and BF12 to concentrate to a greater degree than buprofezin in processed
commodities, DEEM default processing factors were retained for all commodities , except for tomato paste and puree

, which were reduced based on empirical data. Based on the submitted

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 3 of 49 lemon metabolism data, which indicated that residues of concern are primarily found in/on the peel , the maximum theoretical concentration factor for peel was applied to residues in citrus peel.

Total residues of concern in m eat ( i.e., buprofezin and BF2) and milk ( i.e., buprofezin and BF23)

were based on the f

eeding study data which were used to estab lish meat and milk tolerances.

Based on the submitted data

, which indicated a 5x concentration of residues into milk cream and fat and a Log K

ow 

## of 4.31, a default 25x concentration factor was applied to milk fat

. The chronic analysis also i ncorporated the 1 in 10 year average surface drinking water estimate resulting from application of buprofezin to coffee

. The resulting chronic exposure estimates indicate no risks of

concern general population or other population subgroups. The chronic risk exposure estimate for

children 1

- 2 years old

, the most highly exposed population was 91 % of the cPAD

.

The chronic exposure assessment is conservative and is likely to overestimate risks based on a number of factors including, use of 100% crop treated assumptions for a number of crops for

which data w ere unavailable, use of a conservative factor to account for the BF4 Conjugate

, use of default processing factors, and use of drinking water exposure estimates for application of buprofezin to coffee, which is grown in limited areas the U.S. (e.g., Puerto Rico, Hawaii).

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 4 of 49 I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).

This dose is referred to a s the PAD. The PAD is equivalent to a point of departure (POD ; e.g.,

no

- observable

- adverse

- effect

- level ( NOA EL ) ) divided by the required uncertainty or safety

factors. For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary

risk exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments

in more detail a re available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link: http://www.epa.gov/fedrgstr/EPA

- PEST/2000/July/Day

- 12/6061.pdf ; or see SOP 99.6 (8/20/99). The most recent buprofezin dietary ri sk assessment was conducted by B

. Daiss ( DP# 365822

, 6/17/09 ).

II. Residue Information

A. Residues of Concern in Plants Commodi ties

The qualitative nature of buprofezin in plants is understood based on previously submitted
lettuce, tomato, cotton, and lemon metabolism data. [Note: These data are all briefly

summarized in Attachment 1 and includes a figure depicting the proposed pathway in lemon

. ]

B uprofezin is metabolized via hydroxylation of the tert

- butyl group to form an intermediate

m etabolite identified as free Metabolite BF4 ( free Metabolite BF4 was not isolated in studies)

whi ch conjugates or degrades fairly rapidly via oxidation and cleavage to form Metabolite BF9, and ring

- opening to form BF12. In minor routes, buprofezin may undergo opening of the thiadiazine ring to form Metabolite BF25, which may undergo oxidation to form Metabolite
BF11; or free Metabolite BF4 may undergo opening of the thiadiazine ring and further oxidation

to form Metabolite BF26. The BF4 Conjugate may only be r eleased with more forcing acid hydrolysis procedures ( conc. HCl/dioxane ) resulting in a number of hydrolysis products of the procedure itself . I n the lemon metabolism data these hydrolysis products of the study procedure

were identified as BF9, BF12, Metabolite A (now identified as BF26) and Metabolite B

. [Note:

The current e n forcement met hod incorporates only mild acid hydrolysis and is not expected to

release any substantial portion of the BF4 Conjugate.]

Buprofezin was the major residue identified in the lettuce, cotton, and tomato metabolism studies. In the lemon metabolism study, al most all of the residues were in/on the peel (99% TRR) and consisted mainly of buprofezin which declined with longer PHIs (66% TRR at 14

- day

PHI and 18% TRR at 75

- day PHI) and the BF4 Conjugate which increased with longer PHIs ( identified predominately as one of its acid hydrolysis product s
, Metabolite A (now identified at

BF26 ) at 6% TRR at 14

- day PHI and 34% TRR at 75

- day PHI)

. The BF4 Conjugate was only

released after using more fo rcing acid hydrolysis (dioxane:conc. H Cl) as a number of final hydrolysis products of the study procedure. All other residues were <10% TRR , including BF9

and BF12

. Free BF4 was not isolated.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 5 of 49 A grape pro cessing study , which considered the potential for buprofezin to concentrate in processed grape commodities, also, considered the potential for BF9 and BF12 residues (i.e., those residues determined by data collection methods using mild acid hydrolysis) to concentrate

i n processed grape commodities. These data demonstrate the potential for residues of BF12 to concentrate to a greater degree than buprofezin.

MARC met to discuss buprofezin on three occasions ( 3/28/00; 3/6/01; and 12/3/03) and

, in

addition to de terminin g that buprofezin was the residue of concern for tolerance setting and a residue of concern for risk assessment in crops , also found that : (1) residues of concern in grape juice are buprofezin and BF12; (2) residues of BF9 and BF12 should be monitored in all future field trial and processing studies ; (3) additional a pple, grape, and orange processing data determining residues of the BF4 Conjugate should be submitted ; in the absence of these data, the

residues of concern for risk assessment purposes in crop s with an interval greater than approximately 50 days from initial application to harvest should include the BF4 Conjugate ; (4)

the BF4 Conjugate should be estimated using the ratio of the BF4 Conjugate: buprofezin residue s from the lemon metabolism study a nd the buprofezin residues from field trials

. A

recommendation for the numerical ratio of the BF4 Conjugate ;buprofezin residues from the

lemon metabolism study was not provided and left to the discretion of the buprofezin team which has chosen to express the ratio as a Factor for the BF4 Conjugate

. [Note : The available data

collection methods cannot determine the BF4 Conjugate which is released with more forcing acid hydrolysis procedures and identified in the available lemon metabolism data primarily as the hydrolysis products of the study procedure, including BF9, BF12, Metabolite A (now identified

as BF26 ) and Metabolite B .]

A new lemon metabolism study has been submitted (MRID 48540804) which also demonstrates

that most of the residue s are in/on the peel (99% TRR) and consist s mainly of buprofezin which declines with longer PHIs ( 47% TRR at 7

- day PHI, 19% TRR at 35

- day PHI, 9% TRR at 70

- day PHI) and the BF4 Conjugate which increase s with longer PHIs (identified predominately as one of its acid hydroly sis product s
, BF9 at 20% at 7

- day PHI, 29% TRR at 35

- day PHI, and 27%

TRR at 70

- day PHI). Confirming our earlier conclusions, t hese data indicate that over time the

BF4 Conjugate reach es a level of significance when compared to levels of parent ; however, that level of significance may occur earlier and possibly to a greater degree than indicated in the previously submitted lemon metabolism study which was considered by MARC. Qualitatively

these data indicate that residues of the BF4 Conjugate s hould be considered a residue of concern in crops with PHIs much shorter than recommended by the MARC

. RAB4 now finds that BF4 Conjugate should be considered a residue of concern in crops with PHIs >7

- day s

. [Note: In fact, previous risk assessment s have considered the BF4 Conjugate a residue of concern at much

shorter PHIs than recommended by the MARC.] However, given that residue level s were so low

in this new lemon metabolism study (buprofezin in/on peel at < 0.10 ppm at 7

- to 70

- day PHI ),

these data are not considered as robust a s the previous ly submitted lemon metabolism study ( buprofezin in/on peel ≤ 0.551 ppm at 14

- to 75

- day PHI ) for estimating residues of the BF4 Conjugate quantitatively . Hence, in the absence of other evidence/circumstances prec luding the
need, the residues of concern in crops with a PHI greater than approximately 7 days are buprofezin and the BF4 Conjugate and the previously submitted lemon metabolism study will

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 6 of 49 continue to be the basis for estimating residues of the BF4 Conjuga te

.

RAB4 now find that, c ollectively, the available lettuce, tomato, and lemon metabolism data indicate that with relatively short PHIs (≤ 7

- days) the major residue in/on fruits and vegetables is buprofezin

. However, with longer PHIs (> 7

- days) residue levels of the BF4 Conjugate , which is

not released by the mild acid hydrolysis (1N HCl) incorporated into the available data collection
methods, increase relative to the amount of parent present

. Small amounts of metabolites

identified as BF9, BF12, and BF26 may be found but should not reach levels of significance.
BF9, BF12, and BF26 are probably the hydrolysis products of a n intermediate metabolite

identified as free BF4 which probably degrades fairly rapidly under mild acidic conditions

. The

BF4 Conjugate appears to be released only after using more fo rcing acid hydrolysis (dioxane:conc. H Cl; 5:2; v/v; 16 hours at 50°C) as a number of final hydrolysis products of the study procedure , including BF9, BF12, Metabolite A (now iden tified as BF26, and Metabolite B

. Most of the residues remain in/ on crop surfaces but are not readily removed with simple rinsing with water. Residues that penetrate the surface may remain in the peel and over time will consist of significant levels of the BF4 Conjugate

. Based on the results of the grape processing study

which indicate that BF12 residues may concentrate to a greater degree than parent, default processing factors in DEEM should not be reduced ba sed on buprofezin data alone. Table 1 is a summary of the decisions regarding residues of concern for buprofezin.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 7 of 49 Table 1: Summ ary of Buprofezin Residues of Concern

.

Matrix Residues of Concern

For Risk Assessment For Tolerance Expression

Crops with ≤7

- day PHI 1 

### Buprofezin

Buprofezin Crops with >7

- day PHI 1 

### Buprofezin and BF4 Conjugate
Grape juice Buprofezin, BF4 Conjugate , and BF12

Processed Commodities Based on the results of the grape processing study which indicate that BF9 and/or BF12 residues may concentrate to a greater degree than parent, default processing factors in DEEM should not be reduced based on buprofezin data alone.

Rotational crops 2 

### Buprofezin, BF9, and BF12

Ruminant tissue Buprofezin and BF2

Milk Buprofezin and BF23

P oultry and eggs Due to the limited residues in egg and tissue samples collected from the poultry metabolism study, the MARC determined that a conclusion pertaining to the residues of concern in egg and poultry was not possible.

W ater B uprofezin N ot A pplicable

MARC Memos: D264546, T. Bloem, 4/ 20 /0 0; D273214, T. Bloem, 3/ 13 / 01; TXR No. 0052261, T. Bloem, 12/ 10 / 03

. 1 Table updated with RAB4 decision concerning circumstances under which the BF4 Conjugate should be considered a residue

of concern for the risk as sessment and is based on information not available to the MARC.

2 Residues of concern in rotational crops are buprofezin, BF9 and BF12. However, since there are no rotational crop tolerance s, the BF9 and BF12 metabolites are not included in the dietary exposure analysis for rotational crops.



## B. Determination of the Factor for the BF4 Conjugate ( metabolite not determined by data

collection methods)

The MARC recommended that the BF4 Conjugate should be estimated using the ratio of the BF4 Conjugate: buprofezin residue s from the lemon metabolism data but did not offer a numerical

estimate for the ratio. In previous dietary risk assessments, HED has expressed the ratio as a 1.8x Factor for the BF4 Conjugate. HED continues to believe that the factor fo r the BF4 Conjugate should be based on the previously submitted lemon metabolism data. A summary of

these metabolism data is provided in Attachment 1.

Background for 1 .8x Factor for the BF4 Conjugate : The previously submitted lemon metabolism study provided data for fruit treated at 0.89 lb ai/A/application twice at 75

- and 14

- days prior to

harvest and fruit treated only once 75

- days prior to harvest. Buprofezin (66% TRR, PHI=14 days; 18% TRR, PHI=75 days) and the BF4 Conjugate which was identified predominately as the final acid hydrolysis product, Metabolite A (now identified as BF26 ; 5.7 % TRR, PHI = 14 days; 34% TRR, PHI = 75 days) were the major residues . A ll other identified residues were

<10% TRR. Based on the ratio of Metabolite A: buprofezin, residues of the BF4 Conjugate were estimated at 0.09 x and 1.8 x the re sidues of buprofezin at 14

- days and 75

- days PHI, respectively.

However, upon re

- evaluation of the lemon metabolism data and the previous determination of the appropriate Factor for the BF4 Conjugate , all of the identified hydrolysis products of the

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 8 of 49 study procedure which are related to the BF4 Conjugate , which included BF9, BF12, Metabolite A (now identified as BF26), and Metabolite B, were not included in the calculation. Re

evalu a tion o f the appropriate factor ( see Attachment 1 for details ) indicates that, b ased on the lemon metabolism study data discussed ab ove and assuming linearity, residues of the BF4 Conjugate are expected to be significantly greater than buprofezin in/on crops by a factor of 1.8x

at 40

- to 50

- days PHI. Given the uses under consideration, RAB4 finds no need to calculate a

more conservat ive factor based on longer PHI s

. [Note: Based on these data which are used for quantification, residues of the BF4 Conjugate are expected to be insignificant in/on crops at ≤7

- days PHI.]

C. Application of Factor for BF4 Conjugate

– Computation and Exclus ions

An additional factor for the BF4 Conjugate (1.8x ) based on the previously submitted lemon

metabolism data was used for all raw agricultural commodities (RAC) and processed

commodities to account for all residues of concern unless data /circumstances indicated that an

additional factor for the BF4 Conjugate was not necessary. The additional factor for the BF4 Conjugate (1.8x) was incorporated using a simple multiplier of 2.8 applied to the anticipated residue ( AR ) for buprofezin to calculate the tota l residues of buprofezin + the BF4 Conjugate as

follows:

AR Buprofezin x Multiplier (2.8) = (AR Buprofezin) + ( A R Buprofezin x BF4 Conjugate Factor (1.8 x ) )



## Based on the available data, taken together, which indicate that the majority of the residue in/ on plants ≤7

- days after the last foliar treatment is primarily buprofezin, no additional factor for the

BF4 Conjugate is needed for the anticipated residue (AR) estimates for the following raw agricultural commodities (RACs) or members of crop groups/subgr oups which were based on tolerances/field trial data (FTD) reflecting PHIs ≤7

- days: (1) Leaf y Greens, Crop Subgroup 4A; (2) Leafy Petioles, Crop Subgroup 4B; (3) Brassica Head and Stem, Crop Subgroup 5A; (4) Leafy Brassica Greens and Turnip Greens, Crop Subgroup 5B; (5) Fruiting Vegetables, Crop Group 8; (6) Cucurbit Vegetables, Crop Group 9; (7) Citrus Fruits, Crop Group 10; (8) Low Growing Berry, Crop Subgroup 13

- 07G; (9) Coffee; ( 1 0 ) Papaya ; (11) Mango ; (12) Canistel ; a nd (13) Ma mey Sapote.

The need for an additional factor for the BF4 Conjugate for the AR estimates for RACs which are based on PDP monitoring data cannot be dismissed based on registered PHIs (i.e. the shortest permissible PHI which may or may not be typical Good Agricultural Practice ( GAP)) since the time between application and harvest for the PDP monitoring samples is unknown and longer PHIs are expected to result in significant levels of the BF4 Conjugate . However, based on the lettuce metabolism data reflecting a 14

- day PHI indicat ing that the majority of the total radioactive residue (TRR) was buprofezin (89% of the TRR), and given the relatively short growth season of spinach (seed to harvest 35 to 70 days), an additional factor for the BF4 Conjugate is not deemed necessary for AR s used in the chronic analysis for spinach, head
lettuce, and leaf lettuce which are based on spinach PDP monitoring data.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 9 of 49 Also, based primarily on the available lemon metabolism data which demonstrated that the majority of the TRR remained in/on the pe el (99% of the TRR), no additional factor for the BF4 Conjugate is needed for the AR estimates for the RACs of bananas/plantains, tree nuts, and pomegranate whether they are based on FTD or PDP monitoring data. The majority of the buprofezin residues of c oncern are likely to be in/on the peels/skins/shells which are not

consumed.

Also, based on the available cotton metabolism data no additional factor for the BF4 Conjugate

is needed for the AR estimates for the RACs of cotton.

D. Residues of BF9 and BF12 ( metabolites which are determined by the data collection

methods ) in grape juice and other processed commodities

Given the potential for BF9 and BF12 to concentrate to a greater degree than buprofezin in processed commodities, default processing factors were retained, except for tomato paste and puree. Default processing factors for tomato paste (5.4x) and tomato puree (3.3x) were reduced to 1.2x based on tomato processing data ( MRID 44576920 ; DP# 273252, T. Bloem, 3/20/01). Samples of tomato paste and puree were analyzed for residues of BF9 and BF12 which were determined to be <LOQ (<0.05 ppm) and deemed insignificant when compared to residues of the

parent.

E. Residues of Concern in Livestock Commodities

The MARC also previously reviewed ruminant and poultry metabolism and concluded ( D273214, T. Bloem, 3/13/01) that due to the low TRR in eggs and tissue samples collected from the poultry metabolism study, the nature of the residue in poultry could not be determined and for the purposes of risk asse ssment the residues of concern in milk are parent and BF23 and in meat are parent and BF2. Table 1 above provides a summary of the residues of concern.

The residues of concern in milk are buprofezin and BF23. Data from a feeding study in which dairy cow s were dosed with buprofezin at dietary burden levels of 5 ppm, 16 ppm and 52 ppm ( 0.9x, 2.9x, and 9.3x the maximum theoretical daily burden (MTDB) for dairy cattle) were used to determine residue levels in milk for the acute dietary assessment. Residues of buprofezin (0.02 ppm) and BF23 (0.01 ppm) were only determined in milk samples collected from the 9.3x dosing group. Based on these results, an estimate of 0.0032 ppm (0.03 ÷ 9.3) for the combined residues of buprofezin and BF23 in milk at 1x the MTDB was used for the acute dietary analysis. Based on
the submitted data, which indicated a 5x concentration of residues into milk cream and fat and a Log K

ow 

## of 4.31, HED concluded that it is likely that residues will partition into milk fat.
Therefore, a d efault 25x concentration factor was applied for milk fat yielding a residue of 0.08 ppm which was used for the acute analysis.

The residues of concern in ruminant tissues are buprofezin and BF2. Data from the feeding study in dairy cows (dosed at the e quivalent of 0.7x, 2.1x, and 6.8x the beef cattle MTDB) were also used to determine residue levels of buprofezin and BF2 in liver, kidney, fat, and muscle for the

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 10 of 49 dietary assessment. Residues were <LOQ in kidney and muscle from all three dosing levels.

R esidues of buprofezin and BF2 were <LOQ in liver and fat collected from the 0.7x and 2.1x dosing groups and were 0.05 ppm and <0.05 ppm in liver and 0.12 ppm and <0.05 ppm in fat collected from the 6.8x dosing group. Based on these results, an estimate of 0.015 ppm (0.10 ÷ 6.8) was used in the dietary analysis for the combined residues of buprofezin and BF2 in meat, kidney, and liver, and an estimate of 0.025 ppm (0.17 ÷ 6.8) was used for the combined residues of buprofezin and BF2 in fat and meat byproduc ts. Table 2 below provides a summary of the crop residue estimates used in the acute and chronic dietary analysis.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 11 of 49 F. Established/Recommended Tolerances

Buprofezin is currently registered for application to numerous fruit and vegetable commodities

. T olerances for residues of buprofezin rang e from 0.02

- 80 ppm (40 CFR 180.511). Tolerances have also been established for residues of buprofezin in milk (0.01 ppm) and ruminant and hog fat (0.05 ppm), liver (0.05 ppm), meat (0.05 ppm) and meat byproducts (0.05 ppm).

Under PP#1F7905, Nichino America, Inc. is proposing a new use for buprofezin on tree nuts ( including pistachio). In conjunction with th ese uses
, HED is recommending the tolerance s below for residues of b uprofezin, including its metabolites and degradates

. Compliance with the tolerance levels specified below is to be determined by measuring only the buprofezin

.

Nut, tree group 14

................................ ................................ 0.05 ppm

Pistachio

................................ ................................ ............... 0.05 ppm

Under PP#1E7908, Interregional Research Project Number 4 (IR

- 4) is proposing new or expanded uses for buprofezin on succulent beans; Brassica, leafy greens

, crop s ubgroup 5B;

t urnip greens; fruiting vegetables, crop group 8

- 10; citrus fruit, crop group 1 0

- 10; pome fruit, crop group 11

- 10; p ersimmon; and t ea (no U.S. registration)

. HED is not recommending in favor of the expanded use of buprofezin on citrus fruit to include the new members of crop group 10

- 10. In conjunction with these uses, HED is recomm ending the tolerance s below for residues of buprofezin, including its metabolites and degradates

. Compliance with the tolerance levels specified below is to be determined by measuring only the buprofezin

.

Bean, succulent

................................ ................................ .... 0.02 ppm Brassica, leafy greens, subgroup 5B

............................... 60 ppm Turnip, greens

................................ ................................ .... 60 ppm
V egetable, fruiting, group 8

- 10

................................ ............ 2 .0 ppm Fruit, pome, group 11

- 10 (except pear and pear, oriental)

.. 3 .0 ppm

Pear

................................ ................................ ...................... 6.0 ppm Pear, oriental

................................ ................................ ........ 6.0 ppm Persimmon

................................ ................................ ........... 1.9 ppm

Tea

................................ ................................ ...................... 20 ppm

G. Residues Used in the Acute Analysis

The acute analysis assumed the following: tolerance

- level buprofezin residues or total buprofezin

and BF4 Conjugate residues in plant commodities and 100% crop treated

. The residues of concern

in /on crops with a preharvest interval (PHI) of ≤7 days is bup rofezin and in/on crops with a PHI > 7 days are buprofezin and the BF4 Conjugate

. Since there are no monitoring data for the BF4 Conjugate , BF4 Conjugate residues were estimated , where needed, by multiplying the buprofezin

tolerance level by 2 .8x. [See discussion above concerning the determination and application of the

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 12 of 49 Factor for the BF4 Conjugate

. ] Given the potential for BF9 and BF12 to concentrate to a greater degree than buprofezin in processed commodities, DEEM default processing factors were retained for all commodities, except for tomato paste and puree which were reduced to 1.2x based on empirical data. The residues of concern in grape juice are buprofezin, the BF4 Conjugate , and

BF12. Based on the submitted lemon metabolism data, which i ndicated that residues of concern are primarily found in/on the peel, the maximum theoretical concentration factor for peel was used to estimate total residues of concern in/on citrus peel. Total residues of concern in meat (buprofezin and BF2) and milk ( buprofezin and BF23) were based on the feeding study data which

were used to establish meat and milk tolerances for buprofezin

. Based on the submitted data

, which indicated a 5x concentration of residues into milk cream and fat and a Log K

ow 

## of 4.31, a d efault 25x co ncentration factor was applied to milk fat

. Table 2 is a summary of the crop residue

estimates used in the acute analysis.

H. Residues used in the Chronic Analysis

The chronic analysis assumed average field trial, average USDA Pesticide Data Program (PDP) , or tolerance

- level crop residues based on the available data. The residue(s) of concern in/on crops with a preharvest interval (PHI) of ≤7 days is buprofezin and in/on crops with a PHI >7 days are buprofezin and BF4 Conjugate . The residues of concern in grape juice are buprofezin, BF4 Conjugate , and BF12. Since there are no monitoring data for BF4 Conjugate , BF4 Conjugate residues were estimated, where needed, by multiplying the buprofezin anticipated residue (AR) level by 2 .8x. [See discussion above concerning the determination and application of the Factor

for the BF4 Conjugate .] Given the potential for BF9 and BF12 to concentrate to a greater degree than buprofezin in processed commodities, DEEM default processing factor s were retained for all commodities, except for tomato paste and puree which were reduced to 1.2x based on empirical

data . Based on the submitted lemon metabolism data, which indicated that residues of concern are primarily found in/on the peel, the maxim um theoretical concentration factor for peel was used to estimate residues of concern in citrus peel. The chronic analysis used available screening

- level percent crop treated estimates or projected percent crop treated estimates

. If no %CT data was

avail able 100% CT was assumed. Total residues of concern in meat (buprofezin and BF2) and milk (buprofezin and BF23) were based on the feeding study data which were used to establish

meat and milk tolerances for residues of buprofezin

. Based on the submitted data, which indicated a 5x concentration of residues into milk cream and fat and a Log K

ow 

## of 4.31, a default 25x concentration factor was applied to milk fat. Table 2 is a summary of the crop residue estimates used in the chronic analysis.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 13 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Crop Subgr oup 4A

– Leafy Greens

Amaranth; Arugula; Cress; Chrysanthemum; Endive; Dandelions; Parsley

100 100

1 Vegetable, leafy, except
Brassica, group 4, except head

lettuce and

radicchio

35

Head lettuce

and

Radicchio

6.0 7.18 7 2008

Ref. 1 Acute = Tolerance

Chronic = Average Field Trial Data (FTD) reflecting 7

- day PHI (Spinach)

DP#s 340284 and 345185, T. Bloem, 1/16/08.

Analyzed for parent, BF9 and BF12; BF9 and BF12 <LOQ (<0.01 ppm) in/on all samples.

Note: Did not translate spinach PDP data due to differ ences in %CT

Lettuce, head 1 0.0178 Translated from Spinach.

Le ttuce, leaf 1

Radicchio

100 1.99 Acute = Tolerance

Chronic = Average FTD reflecting 7

- day PHI (Head Lettuce with wrapper leaves)

DP#s 340284 and 345185, T. Bloem, 1/16/08.

Analyzed for parent, BF9 and BF12; BF9 and BF12 <LOQ (<0.01 ppm) in/on all samples

Note: Did not translate spinach PDP data due to differences in %CT

Spinach

30 0.0178 Acute = Tolerance

Chronic = PDP (2009 Spinach)

PDP Data: 298 monitoring samples with zero detects (Range of LODs 0.010

– 0.021 ppm)

Using 1⁄2LOD in calculations, the Average Residue Estimate = 0.0178 ppm

Crop Subgroup 4B

– Leafy Petioles

Cardoon; Celtuce; Fennel;
Rhubarb; Swiss chard

100 100

1 35 4.10 7 2008

Ref. 1 Acute = Tolerance

Chronic = Average FTD reflecting 7

- day PHI (Celery)

DP#s 340284 and 345185, T. Bloem, 01/16/08.

Analyzed for BF9 and BF12; BF9 ≤ 0.04 ppm and BF12 <LOQ (<0.01 ppm) in/on all samples Celery

18

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 14 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Crop Subgroup 5A

– Brassica Head & Stem

Broccoli

100 55

1 12 1.03 1 See

BEAD History Acute = Tolerance

Chronic = Average FTD reflecting 1

- day PHI (Broccoli)

DP#s 355894 and 355364, B. Daiss, 1/14/09

Analyzed for BF9 and BF12; BF9 and BF12 <LOQ (<0.01 ppm) in/on all samples Cabbage, Chinese, Mustard 100

Cabbage, Chinese, Napa 100

Kohlrabi 5

Broccoli, Chinese 55

Cauliflo wer 48

Cabbage 40

0.079 Acute = Tolerance

Chronic = Average FTD reflecting 1

- day PHI (Cabbage without wrapper leaves)

DP#s 355894 and 355364, B. Daiss, 01/14/09

See DER 47389001.der.doc for details.

Analyzed for BF9 and BF12; BF9 and BF12 <LOQ (<0.01 ppm) in/on all samples Brussels sprouts

61

Crop Subgroup 5B

– Leafy Brassica Greens and Turnip Greens

Broccoli raab; cabbage,
Chinese (bok choy); collards;
kale; mustard greens; rape
greens; turnip greens 100 100 1 60 20 1 New Use Acute = Tolerance

Chronic = Average FTD reflecting 1

- day PHI (Mustard Greens)

DP#s 395215, 393931, S. Hummel, 7/26/12

Crop Group 6

– Legume Vegetables

- Succulent Beans Only

Broad bean; cowpea; lima
bean; snap bean

Note: Commodities listed
limited to only those listed in

DEEM. 100 100 1 0.056 0.056 14 Expanded

New Use Acute and Chronic = Tolerance (0.02 ppm) x Multiplier (2.8)

Tolerance based on FTD (snap beans) reflecting 9

- to 34

- days PHI

DP#s 285400, 285401, and 28540, T. Bloem, 10/9/02

DP#s 395215, 393931, S. Hummel, 7/26/12

Note: Use on snap beans expa nded to succulent beans

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 15 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Crop Group 8

– Fruiting Vegetables

Pepper, nonbell; Eggplant;

Okra

100 100 1

2.0 0.56 1 Expanded

New Use Acute = Tolerance

Chronic = Average FTD reflecting 1

- day PHI ( Nonbell pepper, Bell pepper, Tomato)

DP#s 340284 and 345185, T. Bloem, 1/16/08.

DP#s 395215, 393931, S. Hummel, 7/26/12

Note 1: Use on fruiting vegetables, group 8 expanded to fruiting vegetables, group 8

- 10

Note 2: Default processing factors for tomato paste (5.4x) and tomato puree (3 .3x ) were reduced to 1.2x based on tomato processing data (DP# 273252, T. Bloem, 3/20/01). Analyzed for residues of BF9 and BF12; residues of BF9 and BF12 were <LOQ (<0.05 ppm) and deemed insignificant when compared to parent. Pepper, bell 100 1 0.34

Tom atillo 100 1

0.129 Toma to 2.5 1

Tomato, paste; Tomato,

puree 2.5 1.2

Tomato, dried 2.5 14.3

Tomato, juice

2.5 1.5

Crop Gr oup 9A

– Cucurbit Vegetables

– Melon

Cantaloupe

100 5

1 0.5 0.150 1 2012 Acute = Tolerance

Chronic = Average FTD reflecting 1

- day PHI (Cantaloupe)

DP#s 390883 and 390886, G. Otakie, 10/19/11

Note: Amended use to lower the PHI from 7

- to 1

- day granted. Available PDP data should not be used since these monitoring data do not reflect the shortest PHI. Casaba 100

Ho neydew melon 2.5

Watermelon 2.5

Crop Group 9B

– Cucurbit Vegetables

– Squash Cucumbers

Balsam pear

100 100

1 0.5 0.136 1 2012 Acute = Tolerance

Chronic = Average FTD reflecting 1

- day PHI (Cucumber, Summer Squash)

DP#s 390883 and 390886, G. Otakie, 10/19/11

Note: Amended use to lower the PHI from 7

- to 1

- day granted. Available PDP data should not be used since these monitoring data do not reflect the shortest PHI. Chayote, fruit; Chinese waxgourd

Cucumber 0.082

Pumpkin; Squash, winter; Squash summer 1 0.136

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 16 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Crop Group 10

– Citrus Fruits

Orange; Lemon

100 2.5 1

2.5 0.0219 3 4/2005

BEAD History Acute = Tolerance

Chronic = PDP (2009 Orange) x Multiplier (2.8)

744 NonDetects (0.010

– 0.030 ppm)

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.0078225 ppm x 2.8 = 0.0219 ppm Orange juic e 1.8

Lemon juice

2.0

Citru s citron; Citrus hybrid; Kumquat; Lime; Pummelo; Tangerine 100 1

1.24 Acute = Tolerance

Chronic = Average FTD reflecting 3

- day PHI (Orange; only used MRID 45694204)

DP# 296492, T. Bloem, 12/17/03 ( Orange residue data reflecting 1

- to 3

- day PHI )

Note: No factor for BF4 Conjugate needed

Note: Did not translate orange PDP data due to differences in %CT Lime juice 2.0

Tange rine juice 2.3

Grape fruit

1 1

0.0066 Acute = Tolerance

Chronic = PDP (2006 Grapefruit) x Multiplier (2.8)

743 NonDetects (0.0005

– 0.015 ppm)

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.0023575 ppm x 2.8 = 0.0066 ppm Grape fruit juice

2.1

Citru s oil

2.5 1 80 80 Acute and Chronic = Tolerance

Supporting field trial and processing data reflect a 3

- day PHI; no factor for BF4 Conjugate

needed.

DP# 296492, T. Bloem, 12/17/03 (Orange residue data reflecting 1

- to 3

- day PHI)

DP#s 319815, 319816, 319817, 319820, 323506, 323507, 323508, 323509, 323811, T. Bloem, 12/14/05 (Orange processing data reflecting a 3

- day PHI)

Note: BF4 Conjugate are not expected to concentrate in citrus oil (DP# 296492, T. Bloem, 12/17/03).

Orange peel; Lemon peel

1 7.5 0.0723 Acute = Tolerance (2.5 ppm) x Max. Theoretical Conc. Factor for citrus peel (3.3x)

Chronic = Anticipat e Residue Est. for Orange/Lemon ( see Orange and Lemon) x Max. Theoretical Conc. Factor for citrus peel (3.3x)

Note: Lemon Metabolism Data indicate that 99% of residues are in/on the peel . Acute does not

include a n additional factor for BF4 Conjugate because PHI is 3 days. Chronic does include an additional factor for BF4 Conjugate because AR Est. based on PDP data.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 17 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Crop Group 11

– Pome Fruits

A pple

100 5 1

8.4 0.0095 14 2005

Ref. 2 Acute = Tolerance ( 3 .0 ppm) x Multiplier (2.8)

Chronic = PDP (2009 Apple) x Multiplier (2.8)

3 (0.4%) Detects (0.002, 0.0058, and 0.035 ppm)

741 NonDetects (0.001

– 0.021 ppm) Ave. 0.006645 ppm/2 = 0.0033225 ppm

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.0033666 ppm x 2.8 = 0.0095 ppm

Note 1: There is an outstanding apple processing study for residues of BF9 and BF12 (determined by the data collection method). HED has recommended (DP# 293230, T. Bloem, 1/7/04) that in the absence of these data the risk assessment should use the DEEM default processing factors for apple processed commodities.

Note 2: There are available apple juice PDP monitoring data which found no detectable residues of buprofezi n. However, these data would indicate a higher estimate for buprofezin in apple due to higher limits of detection for the analytical methods used for data collection. These data are

summarized below.

PDP (2007 and 2008 Apple juice) x Multiplier (2.8)

74 0 Nondetects (0.015

– 0.040 ppm) Ave. 0.0327703 ppm/2=0.0163851 ppm

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.0163851 ppm x 2.8 = 0.046 ppm Apple, juice 1.3

Apple, s auce 1 0.0062 Acute = Tolerance ( 3 .0 ppm) x Multiplier (2.8)

Chronic = PDP (2006 Apple sauce) x Multiplier (2.8)

2 (0.3%) Detects (each 0.0002 ppm)

742 Nondetects (0.0001

– 0.015 ppm) Ave. 0.004439 ppm/2 = 0.0022195 ppm

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.002214 ppm x 2.8 = 0.0062 ppm

Apple, dried (B) 100 8 0.0095 See Apple : Blended (B) commodity cannot use monitoring data and %CT

Crabapple; Loquat; Quince

100 1 3.02 Acute = Tolerance ( 3 .0 ppm) x Multiplier (2.8)

Chronic = Average FTD (Pear; 1.08 ppm) x Multiplier (2.8)

DP# 293230, T. Bloem, 1/7/04

Note: Did not translate apple/pear PDP data due to differences in %CT

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 18 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Pear; Pear juice,

100 15 1
16.8 0.075 14 2005

Ref. 2 Acute = Tolerance ( 6 .0 ppm) x Multiplier (2.8)

Chronic = PDP (2009 Pear) x Multiplier (2.8)

33 (4.4%) Detects (0.067

– 0.74 ppm) Ave. 0.171606 ppm

709 Nondetects (each 0.040 ppm) Ave. 0.040 ppm/2=0.020 ppm

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.0267425 ppm x 2.8 = 0.075 ppm

Pear, dri ed (B) 100 6.25 See Pear: Blended (B) commodity cannot use monitoring data and %CT

Crop Group 12

– Stone Fruits

Apricot; Apricot juice

100 51 1

25.2 4.7 14 2007

Ref. 3 Acute = Tolerance (9.0 ppm) x Multiplier (2.8)

Chronic = Average FTD (Peach; 1.68 ppm) x Multiplier (2.8)

DP#s 326792, 326793, 326794, T. Bloem, 2/21/07

Note: Did not translate peach PDP data due to differences in %CT Apricot, dried (B)

6

Cherry

72 1 5.32 1.96 Acute = Tolerance (1.9 ppm) x Multiplier (2.8)

Chronic = Average FTD (Cherry; 0.70 ppm) x Multiplier (2.8)

DP#s 326792, 326793, 326794, T. Bloem, 2/21/07 Note: Did not translate peach PDP data due to differences in %CT Cherry juice

1.5 5.32 1.96

Nectarine

51

1 25.2 4.7 Acute = Tolerance (9.0 ppm) x Multiplier (2.8)

Chronic = Average FTD (Peach; 1.68 ppm) x Multiplier (2.8)

Note: Did not translate peach PDP data due to differences in %CT

Peach

13

1 25.2 0.021 Acute = Tolerance (9.0 ppm) x Multiplier (2.8)

Chronic = PDP (2008 Peach) x Multiplier (2.8)

616 NonDetects (each 0.015 ppm) Ave. 0.015 ppm/2=0.0075 ppm Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.0075 ppm x 2.8 = 0.021 ppm

Peach, dried (B) 100 7 25.2 0.021 See Peach : Blended (B) commodity cannot use monitoring data and %CT

Plum

37 1

5.32 0.54 Acute = Tolerance (1.9 ppm) x Multiplier (2.8)

Chronic = Average FTD (Plum; 0.194 ppm) x Multiplier (2.8)

DP#s 326792, 326793, 326794, T. Bloem, 2/21/07 Note: Did not translate peach PDP data due to differences in %CT Plum, prune (PB) 5 .0

Plum, pr une, juice 1.4

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 19 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Crop Group 13

- 07G

– Berry, low growing

Blueberry, Cranberry

100 100 1

2.5 0.58 3 2008

Ref. 1 Acute = Tolerance

Chronic = Average FTD (Strawberry)

DP#s 340284, 345185, T. Bloem, 1/16/08

Note 1: Did not translate strawberry PDP data due to differences in %CT

Note 2: Cranberry is listed in DEEM under Others Cranb erry juice

1.1

Strawber ry

39 1 0.0093 Acute = Tolerance

Chronic = PDP (2009 Strawberry) x Multiplier (2.8)

744 NonDetects (0.001

– 0.021 ppm) Ave. 0.006645 ppm/2=0.0033225 ppm

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.0033225 ppm x 2.8 = 0.0093 ppm

Note: Strawberry is listed in DEEM under Others

Crop Group 14

– Tree Nuts

Almond

100 1

1 0.05 0.05 60 2006

BEAD History Acute and Chronic = Tolerance

DP#s 395215, 393931, S. Hummel, 7/26/12

Note: Lemon Metabolism Data indicate that 99% of residues are in/on the peel. No Factor for

BF4 Conjugate needed ; most of the residues of concern are expected to remain in/on the shell

which is not consumed

. Pistachio 5

Brazil nut; Butternut; Cashew; Chestnut; Filbert; Hickory nut; Macadamia nut;
Pecan; Walnut 100 New Use

Crop Group O

– Other (only those RACs with tolerances which are listed in DEEM)

Acerola; Avocado; Cherimoya; Feijoa; Guava;
Jaboticaba; Passionfruit; Soursop; Starfruit; Sugar apple 100 100 1 0.84 0.84 21 2005

BEAD History Acute and Chronic = Tolerance (0.30 ppm) x Multiplier (2.8)

DP# 2932 30, T. Bloem, 1/7/04 (Avocado)

DP#s 285400, 285401, 285402, T. Bloem, 10/9/02 (Lychee)

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 20 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Banana; Plantain

100 100 1

0.20 0.0075 1 2001

BEAD history Acute = Tolerance

Chronic = PDP (2006 and 2007 Banana)

1486 NonDetects (each 0.015 ppm) Average 0.015 ppm/2 = 0.0075 ppm

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.0075 ppm

Note 1: Average FTD reflecting 1

- day PHI (peeled Banana LOD) = 0.01 ppm

DP# 273252, T. Bloem, 3/20/01

Analyzed for parent, BF9 and BF12. Parent <LOQ (<0.01 ppm) in/on all peeled banana samples. BF9 and BF12 <LOQ (<0.01 ppm) in/on all peeled /unpeeled banana samples.

Note 2 : Lemon Metabolism Data indicate that 99% of residues are in/on the peel . No additional factor for BF4 Conjugate needed; most of the residues of concern are expected to remain in/on the peel which is not consumed. Banana dried ; Plantain dried (B) 3.9

Coffee 100 100 1 0.35 0.13 0 Acute = Tolerance (0.35 ppm coffee, green bean)

Chronic = A verage FTD reflecting 0

- day PHI (Coffee, green bean)

DP# 355364, 355894, B. Daiss, 1/14/09

Cottonseed oil 100 1 1 0.35 0.35 28 Acute and Chronic = Tolerance

D273252 , T. Bloem, 3/20/01

Note: Based on Cotton Metabolism Data no additional Factor for BF4 Conjugate is needed

.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 21 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Grape

100 15 1

7.0 0.0130 7 2007

Ref. 3 Acute = Tolerance (2.5 ppm) x Multiplier ( 2.8)

DP#s 360271, 360272, 360273, T. Bloem, 2/21/07.

Chronic = PDP (2009 Grape) x Multiplier (2.8)

71 (9.5%) Detects (0.001

– 0.14 ppm) Ave. 0.01523

673 NonDetects (0.001

– 0.021 ppm) Ave. 0.007033 ppm/2 = 0.0035165 ppm

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.0046343 ppm x 2.8 = 0.0130 ppm

Note Concerning Juice: PDP (2008 Grape Juice) x Multiplier (2.8)

745 NonDetects (0.0006

– 0.015 ppm) Ave. 0.004736 ppm/2 = 0.002368 ppm

Using 1⁄2LOD in calculations, the Ave. Residue Estimate = 0.002368 ppm x 2.8 = 0.0066 ppm

Note: Cannot use P DP juice data because this approach does not allow adequate estimation of

metabolite B12.

Note: Revised regional use pattern in AZ and CA (DP# 369210, J. Stokes, 1/26/10) to use same

seasonal total use rate with a 30

- day PHI was granted. Available PDP da ta can be use since

these monitorin g data are expected to reflect the maximum seasonal use rate and the shortest

PHI. Grape juice 1.2

Grape, raisin

4.3

Lychee; Longan; Spanish

lime 100 100 1
0.84 0.84 21 Acute and Chronic = Tolerance (0.3 ppm) x Multiplier (2.8)

DP#s 285400, 285401, 285402, T. Bloem, 10/9/02 (Lychee) Lychee drie d 1.85

Olive

100 100 1 9.8 3.0 21 Acute = Tolerance (3.5 ppm olive; 4.8 ppm olive oil) x Multiplier (2.8)

Chronic Olives = Average FTD reflecting 21

- to 23

- day PHI (Olive; 1.07 ppm) x Multiplier (2.8)

Chronic Olive oil = AR Olives (3.0 ppm) x Processing Factor for Buprofezin (3.0x)

DP#s 340284, 345185, T. Bloem, 1/16/08 Olive Oil 1 13.4 9.0

Papaya, Canistel, Mango; Sapote, mamey

100 100 1 0.90 0.59 3 Acute = Tolerance

Chronic = Average FTD reflecting 2

- to 3

- day PHI (Papaya)

DP#s 326792, 326793, 326794, T. Bloem, 2/21/07

Only analyzed for parent. Papaya dried 1.8 0.90 0.59

Papaya juice 1.5 0.90 0.59

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 22 of 49 Table 2. R esidues in/on Crops Used in the Acute and Chronic Dietary Exposure Analysis

Commodity %CT Process

Factor Residues Used in Analysis (ppm) Registered Use

Information Source for Anticipated Residues (AR) /COMMENTS

Multiplier (2.8) is used to account for residues of buprofezin and BF4 Conjugate

Multiplier (2.8) = (AR Buprofezin) + (AR Buprofezin x BF4 Conjugate Factor (1.8 x )) A C Acute Chronic PHI

(days) Year

Registered

Pomegranate

100 100 1 1.9 0.194 14 Acute = Tolerance

Chronic = Average FTD (Plum; 0.194 ppm)

DP#s 355894, 355364, B. Daiss, 1/14/09

DP#s 326792, 326793, 326794, T. Bloem, 2/21/07 Note1: Lemon Metabolism Data indicate that 99% of residues are in/on the peel

Note 2: From ChemSAC Meeting 2/13/08; pomegranate has an inedible peel

Persimmon 100 100 1 5.32 0.54 14 New Use Translated from plums

Tea 100 100 1 20 20 ?? New Use Acute and Chronic = Tolerance

DP#s 395215, 393931, S. Hummel, 7/26/12

Water 100 100 1 0.05 82 0.0186 NA NA D P#s 395217 and 393932, R. Parker, 4/5/12

Crop Group D

– Dairy

Milk fat 100 100 1 0.08 0.08 NA NA Acute and Chronic = Feeding Study Data (FSD)

D293230

Crop Group M

– Meat

Meat; Kidney; Liver

100 100 1
0.015 0.015 NA NA Acute and Chronic = Feeding Study Data (FSD)

D293230 Meat dried 1.92

Meat byproducts; Fat 1 0.025 0.025

Reference 1: Use registered on end

- use product 71711

- 20 label dated 7/08.

Reference 2: Use registered on end

- use product 71711

- 15 label (supplemental) dated 4/05.

Reference 3: Use registered on end

- use product 71711

- 21 label dated 10/07.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 23 of 49 III. Water D ata

Drinking water residues were incorporated directly into the acute and chronic dietary analyses ( “water, direct, all sources” and “water, indirect, all sources”) and were provided by the Environmental Fate and Effects Division (EFED; D P#s 395217 and 393932, R. Parker, 4/5/12 ). EFED generated the surface water and ground water estimates using the Pesticide Root Zone Model 3 (PRZM3; ver. 3.12.2; 2

- May

- 2005)/Exposure Analysis Modeling System (EXAMS;
ver. 2.98.04.06; 25

- Apr

- 2005 ) an d Screening Concentration in Ground Water (SCIGROW; Tier 1) models, respectively. For the purposes of assessing drinking water risk, estimated drinking water exposure concentrations ( EDWCs ) are based on the use with the highest potential exposure. Based on Tier II exposure modeling, past assessments have found the maximum exposure to be from the use s on coffee and citrus (DP # 360583, M. Corbin, 1/8/09) based on the

Puerto Rico Coffee and Florida Citrus scenarios. The proposed new and expanded uses yield

EDWC s below those previously determined

. T he cof fee use yields the highest EDWC s to date. The EDWCs for coffee are based on a maximum seasonal application rate of 4 lb ai/acre

. Updated EDWC s are provided in Table 3.

Table 3 . Maximum EDWCs (μg/L) from registered and proposed uses of buprofezin.

Surface Water a 

### Groundwater b



### Use Acute

[1

- in

- 10 year peak] Chronic

[1

- in

- 10 year average] 30

- year average Acute and Chronic

Maximum Current Use

Citrus

- Fl 57.4 12.5 9.1 0.09

Coffee

- PR 58.2 18.6 13.6 0.09
Proposed Uses Strawberry 11.2 3.8 2.9

N/A Low

- growing

berries 13.1 4.2 2.6

Leafy vegetables 20.4 6.4 4.5

Cranberries c 

### 47.9 N/A N/A

a Generated using Tier II linked simulation models PRZM (3.12.2) /EXAMS (2.98.04.06).

b Generated using Tier I model SCIGROW (2.3). c Generated using Tier 1 Rice Model v. 1.0.



## IV. DEEM

- FCID Program and Consumption Information

Buprofezin acute and chronic dietary exposure assessments were conducted using DEEM

FCID (Ver. 2.03), which incorporates consumption data from USDA’s CSFII, 1994

- 1996 and

1998. The 1994

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

individuals over two non

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

linked to EPA

- defined food commodities (e.g. apples, peeled fruit

- cooked; fresh or N/S; baked;

or wheat flour

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic expos ure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on analysis of the

1994

- 96, 98 CSFII consumption data, whi ch took into account dietary patterns and survey

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## Page 24 of 49 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+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by th e 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 resi due 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.

For acute exposure assessments, individual one

- day food consumption data are used on an

individual

- by

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

com modities/food forms) and a per

- capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for Tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 25 of 49 IV. Toxicological Information

HED evaluated the toxicology data base for buprofezin and selected the following doses and endpoints for acute and chronic dietary and drinking water risk assessments.

Table 4 . Summary of Toxicological Doses and Endpoints for Buprofezin for Use in Dietary Human Health Risk

Assessments

Exposure/

Scenario Point of

Departure Uncertainty/F

QPA Safety

Factors RfD, PAD, LOC

for Risk

Assessment Study and Toxicological Effects

Acute Dietary (General Population) An acute RfD for the general population or any population subgroups was not selected because no

effect attributable to a single (or few) day(s) oral exposure was observed in animal studies.

Acute Dietary (Females 13

- 49

y rs) NOAEL = 200

mg/kg/day UF A 

### = 10x

UF H 

### =10x FQPA SF= 1x Acute RfD = 2.0

mg/kg/day

aPAD = 2.0 mg/kg/day Developmental Toxicity Study

- Rat

Developmental LOAEL = 800 mg/kg/day based on reduced ossification & decreased body weight in offspring.

Maternal LOAEL = 800 mg/kg/day based on mortality, decreased food consumption, weight loss, clinical signs, decrea sed pregnancy rates and increased resorption rates

Chronic Dietary (All Populations) NOAEL = 1.0

mg/kg/day UF A 

### = 3x

UF H 

### =10x FQPA SF= 10x Chronic RfD =

0.0033 mg/kg/day

cPAD = 0.0033 mg/kg/day Two

- year Chronic/C ancer Study

- Rat

LOAEL = 8.7 mg/kg/day based on

increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males.
Cancer ( all

routes ) “C” Possible human carcinogen. (No Q 1 

### *). The cRfD is considered protective of the cancer effects.

1 F QPA SF = total of FQPA UF L (LOAEL to NOAEL), FQPA UF S (subchronic to chronic), FQPA UF DB (database), and/or

SF FQPA ( uncertainties related to exposure and residual uncertainties regarding pre

- or post

- natal toxicity ); see D3 39827 ( T. Bloem

et al.

, in draft ) for discussion.

2 U F A/H = intraspecies (default of 10x) and interspecies (default of 10x) uncertainty factor; since it has been established that rats are more susceptible to thyroid effects than humans, the chronic interspecies UF was reduced to 3x (see D3 39827 ( T. Bloem et
al.

, in draft ) for discussion).



## V. Results/Discussion

A screening level a cute analys i s w as performed using DEEM

- FCID to estimate dietary

exposure . Acute analysis results are reported for the population subgroup females 13

- 49 years old. No acute endpoint w as identified for the remaining population subgroups. The 95 th



## percentile acute food exposure estimate for females 13

- 49 years old is not of concern to HED ( 5 % aPAD; see Table 5 ).

Table 5 : Summary of Acute Dietary Exposure and Risk for Buprofezin

. Population Subgroup aPAD (mg/kg/day) Acute (95th Percentile) Exposure (mg/kg/day) %aPAD

Females 13

- 49 years old 2 0. 0987 5

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## Page 26 of 49 A refined chronic analysis was performed using DEEM

- FCID to estimate dietary exposure. The results reported are for the general U.S. Population, all infants (<1 year old), children 1

- 2 years old, children 3

- 5 years old, children 6

- 12 years old, youth 13

- 19 years old, females 13

- 49 years old, adults 20

- 49 years old , and adults 50+ years old. The chronic food exposure estimates

are also not of concern to HED ( 91 % cPAD; children 1

- 2 years old were the most highly exposed population; see Table 6 ).

Table 6 : Summary of Chronic Dietary Exposure and Risk for Buprofezin

.
Population Subgroup cPAD (mg/kg/day) Chronic Exposure (mg/kg/day) %cPAD
General U.S. Population

0.0033 0.001 7 5 1 All Infants (< 1 year old) 0.00 2 2 6 8

Children 1

- 2 years old 0.00 30 91

Children 3

- 5 years old 0.00 2 7 82

Children 6

- 12 years old 0.001 5 4 7

Youth 13

- 19 years old 0.001 4 4 2

Adults 20

- 49 years old 0.001 4 4 3 Adults 50+ years old 0.00 19 5 8

Females 13

- 49 years old 0.001 4 4 3



## VI. Characterization of Inputs/Outputs

The acute analysis is conservative as tolerance

- level residues were assumed for the majority of the commodities and 100% crop treated was assumed for all commodities. The chronic analysis was refined through the use of average field trial residues, p ercen t crop treated data

, and PDP

data where available

. While refined, the chronic analysis should still be considered conservative and likely to overestimate risk based on use of a number of conservative assumptions to estimate

exposure.

In the course of conducting a refined dietary exposure analysis, decisions are made regarding the residue data used in the analysis (e.g., field trials, monitoring data, etc.), refinements incorporated in the analysis (such as percent crop treated and proc essing factors), and a variety of other issues which may be chemical

- or crop

- specific. The following provides a discussion of the assumptions used in the buprofezin dietary analysis and the uncertainties associated with those assumptions.

Uncertainties

Residue Data and Assumptions

The acute analysis used t olerance level residues which were established based on field trial data.

The chronic analysis assumed average field trial, average USDA Pesticide Data Program, or

tolerance

- level crop residues based on the available data

. Data from feeding studies were used to

establish meat and milk residues for the chronic analysis. PDP and field trial residues in

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 27 of 49 representative commodities were translated to the remaining commodities in the crop group

acco rding to HED SOP 2000.1.

PDP data were used where available and appropriate i.e., in some cases available PDP data were not used for certain crops because the data were collected prior to or shortly after buprofezin was registered for use on those crop s. PDP data from representative commodities w ere used to estimate residues for the chronic dietary assessment for pome fruits (Crop Group 11

– except crabapple , loquat and quince) , banana/plantain, grape, grapefruit, lemon, lettuce (head and leaf),

orange, peach, spinach, and strawberry commodities. PDP non

- detects were assumed to be 1⁄2

LOD

.

Tolerance levels were used for succulent beans, citrus oil, tree nuts, cottonseed oil, tea, and most of the tropical fruits (excluding papaya, mango, canistel, black and mamey sapote, and star apple). Field trial data from representative commodities w ere used for the remaining

commodities. Tolerance s and field trial data estimates are based on quantifiable residues for all

of these commodities.

The inclusion of BF4 Conjugate as a residue of concern i s based on a lemon metabolism study

. The current acute and chronic assessment s estimat ed total residues of concern, including BF4 Conjugate , by apply ing a multiplier of 2.8x to the anticipated residue estimate for buprofezin.

Th e use of a factor to account for BF4 Conjugate was used for all raw agricultural commodities and processed commodities unless data/circumstances indicated that an additional factor for the

BF4 Conjuga te was not necessary. The use of a factor to account for BF4 Conjugate should b e considered a highly co nservative assumption since most of the BF4 Conjugate is found on the peel and not in the pulp.

Processing Factors

Given the potential for BF9 and BF 12 to concentrate to a greater degree than buprofezin in processed commodities, DEEM default processing factors were retained for all commodities

, except for tomato paste and puree which were reduced based on empirical data. Based on the

submitted lemon m etabolism data, which indicated that residues of concern are primarily found in/on the peel, the maximum theoretical concentration factor for peel (3.3x) was applied to residues in citrus peel.

Adequacy of %CT data

Percent crop treated data were used when available for the chronic dietary analysis. Sc r eening level or projected usage data were available for most crops

. Screening level estimates may underpredict usage. The use of 100% crop treated assumptions for commodities for which %CT

data were n ot available is a conservative assumption.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 28 of 49 Drinking Water EDWCs

The proposed new use on c offee yields the highest EDWCs to date . Therefore the coffee EDWCs were used to estimate drinking water exposures for this assessment. Water is a significant contributor to the chronic dietary exposure and risk assessment as discussed below. Since coffee is grown in limited areas in the US (e.g., Hawaii, Puerto Rico) the risk contribution from EDWCs estimated for use of buprofezin on cof fee is limited to th ose areas

.

Significant Risk Contributors ("Risk Drivers")

Based on a critical commodity analysis, t he major contributors to the chronic analysis for

children 1

- 2 years old (most highly exposed population subgroup) were the new use on Brassica (Cole) leafy vegetables , crop subgroup 5B

- 28 % cPAD ; water

- 28 % cPAD ; and stone fruit

- 1 3 % cPAD.

VII. Conclusions

Based on a screening level acute dietary and drinking water analysis, the exposure estimate for

females 13

- 49 years old is not of concern to HED ( 5 % aPAD). No acute endpoint was identified for the remaining population subgroups.

Based on a refined chronic dietary and drinking water analysis , the exposure estimates are not of

concern to HED for Children 1

- 2 years old

, the most highly exposed population ( 91 % cPAD ). Exposure estimates for the general population are not of concern ( < 100% cPAD). The chronic exposure assessment should be considered conservative and is likely to overestimate risks based on a number of factors including, use of 100% crop treated assumptions for a number of crops
for which data was unavailable, use of a conservative factor to account for metabolites, use of default proc essing factors, and use of drinking water exposure estimates for appli cation of buprofezin to coffee which is grown in limited areas in the U.S. (e.g., Puerto Rico, Hawaii).

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 29 of 49 Attachment1: Metabolism Data Summaries

Attachment 2: Registration History Prepared by BEAD (8/24/11)

- Excerpted

Attachment 3 : Percent Crop Treated Data (DP# 395596)

- Excerpted

Attachment 4 : DEEM

- FCID acute residue file

Attachment 5 : DEEM

- FCID acute exposure estimates

Attachment 6 : DEEM

- FCID chronic residue file

Attachment 7 : DEEM

- FCID chronic exposure estimates

Attachment 8 : Critical Commodity Analysis for Children 1

- 2 years old (chronic)

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 30 of 49 Attachment 1 : Metabolism Data Summaries

Metabolism of [ 14 

### C]

- Buprofezin in Lettuce (MRID 44394049; D261869, 4/24/00, T. Bloem) : Lettuce plants were
treated with [C 14 

### ]

- buprofezin twice at ~0.76 lbs/acre (2x the maximum single and seasonal rate; 12 day treatment interval). TRR in lettuce harvested 14 days after the final treatment was 51.79 ppm. The majority of the radioa ctive residues were either recovered through a surface rinse with ethanol (89% TRR) or extracted with acetonitrile and water (8% TRR). Hydrolysis of the extracted fiber (1.0% TRR) with acid and base released 0.63% and 0.14% of the TRR, respectively (0.2% TRR remaining bound). The majority of the TRR was identified as buprofezin (89% TRR) with minor amounts of BF 9 (0.19% TRR), BF 12 (0.46% TRR), and BF 26 (0.62%). Four unknown peaks were identified, the largest of which was 0.36 ppm (0.69% TRR). A total o f 93% of the TRR was

identified/ characterized.

Disposition and Metabolism of [ 14 

### C]

- Buprofezin in Tomato (MRID 44435903; D261869, 4/24/00, T. Bloem) : Tomato plants were treated with 4 applications of [C 14 

### ]

- buprofezin at ~0.10 lbs ai/acre (0.4x and 0.5x the maximum single and seasonal rates; 14 day re treatment intervals). Tomatoes were harvested 1 hour after the first treatment and 1 hour, 1 day, 3 days, and 7 days after the 4 th 

### application. TRRs in/on to mato fruit generally decreased with

inc reasing p re harvest intervals (0.578 ppm 1 hour P H I; 0.342 ppm, 7

- day P H I). Levels of radioactivity removed with ethanol (26

- 61% TRR) were considerably higher than with water (4

- 16% TRR). The mean level of residues removed by water or ethanol generally decreased with increasing P H I.

A second experiment involved individually treating the fruit of eight tomato plants at various stages of ripening with 0.042 mg of [C 14 

### ]

- buprofezin (applied directly to the fruit surface with a syringe). A tomato fruit sample collected 7 days after treatment was rinsed with ethanol (76% TRR) and the rinsed fruit (24% TRR) was homogenized with ethyl acetate (17% TRR). Chromatographic analysis of the ethanol wash and ethyl ac e tate extract indicated that 90% of the TRR was buprofezin (3% unidentified; 7% unextracted material). A separate tomato fruit sample (0.353 ppm) collected 7 days after treatment was washed with ethanol (45% TRR) and separated into peel (41% TRR) and pulp (13% TRR), d emonstrating that the majority of the radioactive residue was on the surface or in the peel.

Metabolism of [C 14 

### ]

- Buprofezin in Cotton (MRID 44394048; PP# 7F04923; D261869, 4/24/00, T. Bloem) : Cotton plants were treated with [C 14 

### ]

- buprofezin at 0.77 lbs a i/acre 97 and 139 days after planting (2x the maximum single and seasonal application rates). The mean TRR in cotton gin byproducts and seed harvested 27 days after the second application was 15.64 ppm and 0.37 ppm, respectively. The major residue in bot h cotton gin byproduct and seed was buprofezin (58.8% and 57.3% of the TRR, respectively). Other compounds identified in both cotton gin byproduct and seed included BF 9 (5.8% and 1.4%, respectively), BF 12 (5.7% and 1.5%, respectively), and BF 26 (6.1% a nd 0.4%, respectively). The total identified/characterized residue in cotton gin byproduct and seed was 79.7% and 75.7%, respectively (unidentified peaks were 7.5% TRR or less). Bound radioactivity accounted for 8.2% and 9.6% of the TRR in cotton gin byp roduct and seed, respectively.

Metabolism of [C 14 

### ]

- Buprofezin in Lemon (MRID s 44576908 and 44576907 ; D 273252

, 3/20/01 T. Bloem) :
Lemon trees grown in a greenhouse were treated with [C 14 

### ]

- buprofezin (phenyl

- ring labeled; specific activity ~40 μCi/mg; formulated as Applaud® 40SC) 75 and 14 days before harvest at ~0.89 lbs ai/acre (0.4x the maximum single and seasonal rate). [Note: The proposed metabolic pathway in lemon is provided in Fi gure I

- A below.] The majority of the total radioactive residue (TRR; 0.940 ppm) was found in/on the peel (ethanol rinse

- 65.2% TRR; peel

- 34.6% TRR). Pulp contained 0.3% of the TRR and was not further analyzed. Peel was extracted with ACN,
ACN/water, and water and the extracts were combined (33.3% TRR), reduced to the aqueous phase, and partitioned with ethyl acetate at acidic, neutral, and basic pH. The combined ethyl acetate fractions (organic soluble

- 12.3% TRR) and the remaining aqueous fraction (aqueous soluble

- 21.0% TRR) were hydrolyzed with conc. HCl/di o xane. [Note: While milder procedures using dilute acid and/or base are expected to provide more accurate assignments of

metab olite structures released, procedures using concentrated acid are expected to release moieties as their final hydrolysis products which could have only a minor relationship to the Conjugate d form of the radioactive portion.]

T he resulting hydrolysates were partitioned with ethyl acetate at unchanged pH, pH7, and pH 10. The various extracts were analyzed resulting in identificat ion of buprofezin (6 6 % TRR) and the hydrolysis products BF9 ( 6.0 %

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 31 of 49 TRR), BF12 (1.7% TRR), M etabolite A (5.7% TRR), and M etabolite B (3.6% TRR). The petitioner was able to demonstrate through LC/M S analysis that M etaboli te A was similar to the principal hyd rolysis product of BF4 ( BF26). Based on these data, the BF4 Conjugate should be estimated at 17% TRR by summing the hydrolysis products (BF9 (6.0% TRR) + BF12 (1.7% TRR) + Metabolite A (5.7% TRR ) + Metabolite B (3.6% TRR)). Based

on the ratio of BF4 Conjugate (17.0% TRR): buprofezin (6 6 % TRR)

, residues of the BF4 Conjugate are expected to

be 0.2 6 x the residues of buprofezin at 14

- days PHI.

The petitioner also presented data from lemon trees treated with [C 14 

### ]

- buprofezin (phenyl

- ring labeled; specific activity ~40 μCi/mg; formulated as Applaud® 40SC) 75 days before harvest at ~0.89 lbs ai/acre (0.4x the maximum single application rate and 0.2x the maximum seasonal rate). The majority of the TRR (0.401 ppm) was found in/on the peel (ethanol rinse

- 15.8% TRR; peel

- 82.9% TRR). Pulp contained 1.2% of the TRR and was not further analyzed. The sample was carried through the same extraction procedures outlined above. The various extracts

were analyzed resulting in identification of buprofezin (18.4% TRR ) and the hydrolysis products BF9 (7. 3 % TRR), BF12 ( 8.1 % TRR), M etabolite A ( 34.0 % TRR ), and M etabolite B (9. 2 % TRR). Based on these data, the BF4 Conjugate should be estimated at 58.6% TRR by s umming the hydrolysis products (BF9 (7.3% TRR) + BF12 (8.1% TRR) + Metabolite A (34.0% TRR) + Metabolite B (9.2% TRR)). Based on the ratio of BF4 Conjugate (58.6% TRR): buprofezin (18.4% TRR) , residues of the BF4 Conjugate are expected to be 3.2 x the resid ues of buprofezin at

75

- days PHI.

Figure I

- A . Proposed Metabolic Profile of Buprofezin in Lemon

.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 32 of 49 Based on the lemon metabolism study data discussed above and assuming linearity, residues of BF4 Conjugate are expected to be significantly greater than buprofezin by a factor of 1.8x at 40

- to 5 0

- days PHI. See Figure 1

- B

below. Hence, f

or crops with a PHI of 4 0

- days or less, a simple multiplier of 2.8 applied to the anticipated residue (AR) estimate for buprofezin will account for residues of buprofezin and the BF4 Conjugate by incorporating a

factor for the BF4 Conjugate based on the available lemon metabolism data as follows:

AR Buprofezin x Multiplier (2.8) = (AR Buprofezin) + ( A R Buprofezin x Factor (1.8) for BF4 Conjuga te )

Figure I

- B

. Factor for BF4 Conjugate Based on Lemon Metabolism Study

y = 20.748x + 8.6054

R2 = 1

0 10 20 30 40 50 60 70 80

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 PHI (days)



### Ratio BF4 Conjugate:Buprofezin Residues



# BF4 Conjugate Factor

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 33 of 49 Attachment 2: Registration History Prepared by BEAD (8/24/11)

- Excerpted

Sept 8, 2000: Buprofezin registered in the US by Arentis Crop Science (Bayer) as 264

- 677

Sept 5, 2001: Aventis established tolerances for residues in or on almonds; banana; citrus; citrus, oil; citrus, dried pulp; grape; grape, raisin; milk; fat (cattle, goats, hogs, horses, sheep); meat byproducts (cattle, goats, hogs, horses, sheep); liver (cattle, goats, hogs, horses, sheep). In addition, this regulation a lso establishes time

- limited tolerances for residues of buprofezin (in or on almond, hulls; cotton, undelinted seed; cotton, gin byproducts; and

tomato. Tolerances expire July 31, 2005.

June 25, 2003: Minor crops registered Interregional Research Project Number 4 (IR

- 4) established tolerances for residues in or on bean, snap, succulent; logan; lychee; pistachio; pulasan; rambutan; and spanish lime.

Aug 6, 2003 (stamped label, OPPIN says Aug 11): 71711

- 16, Buprofezin Technical registered by

Nichino

Apr 8 , 2005: Minor crops registered Nichino America, Inc., established tolerances for residues in or on avocado, papaya, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, birida, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, acerola; pome fruit; peach, meat (cattle, goat, hog, horse, and sheep); kidney (cattle, goat, hog, horse, and sheep); lettuce, head, Lettuce, leaf, and Vegetable, cucurbit; fruit, citrus, grou p 10; citrus, dried, pulp; and citrus, oil

Sept 22, 2006: Minor crops registered
Nichino America, Inc., established tolerances for residues in or on almond hulls; cotton, gin byproducts: Cottonseed; and tomato

June 27, 2007: Minor crops registered Interregional Research Project Number 4 (IR

- 4) established tolerances for residues in or

on fruit, stone, group 12, except apricot and peach; and apricot.

Apr 9, 2008: Minor crops registered Interregional Research Project Number 4 (IR

- 4) established tole rances for residues in or

on berry, low growing , subgroup 13

- 07G; okra; olive; olive, oil; pepper, nonbell; radicchio; vegetable, fruiting, group 8, except non

- bell pepper; and vegetable, leafy, except Brassica, group 4, except head lettuce and radicchio

July 10, 2009: Minor crops registered Interregional Research Project Number 4 (IR

- 4) established tolerances for residues in or on coffee and pomegranates

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## Page 34 of 49 Nichino America, Inc., established tolerances for residues in or on Brassica, head and stem, subgro up 5A

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## Page 35 of 49 Att achment 3 : Percent Crop Treated Data (DP# 395596 , 12/6/11 )

MEMORANDUM

SUBJECT: Recommended PCT Values for Crops Registered for Buprofezin (275100) Use to

Support HED’s Newly Refined Risk Assessment, DP# 395596

FROM: Cynthia Doucoure, Environmental Protection Specialist

Science Information and Analysis Branch

Donald Atwood, Entomologist Biological Analysis Branch Biological and Economic Analysis Division (7503P)

THRU: Diann Sims, Chief

Science Information and Analysis Branch

Arnet Jones, Chief Biological Analysis Branch Biological and Economic Analysis Division (7503P)

TO: Andrew Ertman

Minor Use Team Risk Integration, Minor Use, and Emergency Response Branch Registration D ivision (7505P)

Product Review Panel date: December 6, 2011

SUMMARY

Following a Buprofezin New Use Team Meeting on October 18, 2011, BEAD was asked to determine whether it is appropriate for HED to use the average percent crop treated (PCT) values

fro m the recent Screening Level Usage Analysis (SLUA) or from the percent crop treated for new uses (PCTn) documents that BEAD has provided over the past five years as inputs to HED’s revised chronic dietary exposure analysis. BEAD reviewed available PCTn an d SLUA data provided to HED in the past, along with registration and tolerance information for the various uses to determine the appropriate source for the percent crop treated data. The results are

summarized in the section below.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 36 of 49 RECOMMENDED PCT and PCTn VALUES FOR BUPROFEZIN USES

BEAD has provided HED refined PCT data for 30 uses of buprofezin over the past 5 years, including PCTn values for 20 new uses based on the market leader approach. Using the buprofezin registration history provided by RD, the usage data from the recent SLUA and PCTn documents, and OPPIN data on crop registrations, BEAD determined the appropriate source of PCT values for each of the 30 uses based on the following (except for grapes, which are described below):

1. In cases wher e the use has been registered for less than 5 years, BEAD believes that the original PCTn values provided should be used for the refined chronic dietary exposure

assessment

2. In cases where the use has been registered for more than 5 years, BEAD believes th e SLUA values provided should be used for the refined chronic dietary exposure

assessment

3. Grapes are an exception to these two cases largely due to the increased usage of buprofezin on wine grapes. In this case we believe the PCTn value of 15% should be used for the chronic dietary exposure.

BEAD also considers whether the surveyed data are sufficiently robust to indicate whether the average is a good indicator of future use.

Table 1 contains PCTn values provided previously for uses that BEAD recomm ends HED use for their newly refined risk assessment. These numbers remain valid and should be used for the

refined risk assessment.

Table 1. Recommended PCTn Values for Buprofezin Uses
Crop PCTn (Chronic) Previous memos containing PCTn values

Apples 5* 10/18/2006 (Alsadek and Brassard) Apricots 51 12/05/2008 (Alsadek)

Broccoli/Chinese Broccoli 55 12/05/2008 (Alsadek and Carter) Brussels Sprouts 61 12/05/2008 (Alsadek and Carter) Cabbage 40* 12/05/2008 (Alsadek and Carter)

Cauliflower 48* 12/05/2008 (Alsadek and Carter) Celery 18 01/09/2008 (Alsadek and Carter)

Cherries 72* 12/05/2008 (Alsadek) Grapes 15 12/05/2008 (Alsadek)

Kohlrabi 5 12/05/2008 (Alsadek and Carter)

Nectarines 51 Note: based on 12/07/2007, HED used 60%
PCT; However, BEAD updated the PCTn in 12/05/2008 (Alsadek)

Peaches 13 10/18/2006 (Alsadek and Brassard)

Plums 37 12/05/2008 (Alsadek) Spinach 30 01/09/2008 (Alsadek and Carter)

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 37 of 49 Strawberry 39 01/09/2008 (Alsadek and Carter) Source: BEAD analyses as cited.

* PCT values are available on the buprofezin SLUA for apples, cabbage, cauliflower, and cherries; however, since less than 5 years of survey data are available, the original PCTn values should be used.



## Table 2 contains PCT values from the August 2011 SLUA for uses (except lettuce) that BEAD recommends HED use for their newly refined risk assessment. BEAD has sufficient data on the actual percent of these crops treated with buprofezin to determine the average PCT for these registered uses.

BEAD also provided PCTn values for head lettuce (67%) and leaf lettuce (63%); however, these uses have been registered since 2001 per OPPIN and there’s very little reported usage of buprofezin on lettuce over the past 10 years. California DPR reports use of b uprofezin in terms of pounds a.i. applied on head lettuce in 2004 (1 lb) and 2007 (20 lbs) and on leaf lettuce in 2006 (4 lbs); however, California DPR PCT data for lettuce are not reliable due to differences in their pct methodology and reporting periods. There is no reported use of buprofezin on lettuce in USDA NASS or private market research surveys. As such, BEAD recommends using <1% PCT

for both head and leaf lettuce.

Table 2. Recommended SLUA PCT Values for Buprofezin Uses
Crop Avg PCT (Chronic)

Almonds <1 Cantaloupes 5

Cotton <1 Grapefruit <1 Honeydew <2.5

Lemons <2.5 Lettuce (head)** <1
Lettuce (leaf)** <1 Oranges <2.5

Pears 15

Pistachio 5 Pumpkins* <1 Squash* <1

Tomatoes* <2.5

Watermelons <2.5 Source: Screening Level Usage Analysis (SLUA), August 10, 2011



## * BEAD provided PCTn values previously for pumpkins, squash, and tomatoes; however, since these uses have five or more years of survey data, the SLUA values should be used.

** Lettuce was surveyed but there are no report s of buprofezin usage; BEAD recommends <1% PCT.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 38 of 49 C ONCLUSION

BEAD has considered the available PCT data for each of the 30 uses that HED used previously to refine their chronic dietary exposure analysis in light of the buprofezin registration history provided by RD, the usage data from the recent SLUA and PCTn docum ents, and OPPIN data on crop registrations and conclude that the PCTn and PCT values in Tables 1 and 2 are appropriate for use in the newly refined risk assessment.

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 39 of 49 Attachment 4 : DEEM

- FCID A cute R esidue F ile

Filename: C: \ Buprofezin \ 275100a5

- 31

- 12.R98
Chemical: buprofezin RfD(Chronic): .0033 mg/kg bw/day NOEL(Chronic): 1 mg/kg bw/day RfD(Acute): 2 mg/kg bw/day NOEL(Acute): 200 mg/kg bw/day
Date created/last modified: 05

- 31

- 2012/12:11:28/8 Program ver. 2.03

Comment: *=Fact or for BF4 Conjugates Used

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 04010050 4A Amaranth, leafy 35.000000 1.000 1.000
04010180 4A Arugula 35.0 00000 1.000 1.000 04011040 4A Chrysanthemum, garland 35.000000 1.000 1.000
04011330 4A Cress, garden 35.000000 1.000 1.000 04011340 4A Cress, upland 35.000000 1.000 1.000

04011380 4A Dandelion, leaves 35.000000 1.000 1.000

04011500 4A Endive 35.000000 1.000 1.000
04012040 4A Lettuce, head 6.000000 1.000 1.000
04012050 4A Lettuce, leaf 35.000000 1.000 1.000
04012480 4A Parsley, leaves 35.000000 1.000 1.000

04013130 4A Radicchio 6.000000 1.000 1.000
04013550 4A Spinach 35.000000 1.000 1.000 04013551 4A Spinach

- babyfood 35.000000 1.000 1.000

04020760 4B Cardoon 35.000000 1.000 1.000 04020850 4B Celery 35.000000 1.000 1.000
04020851 4B Celery

- ba byfood 35.000000 1.000 1.000
04020860 4B Celery, juice 35.000000 1.000 1.000

04020870 4B Celtuce 35.000000 1.000 1.000
04021520 4B Fennel, Florence 35.000 000 1.000 1.000

04023220 4B Rhubarb 35.000000 1.000 1.000

04023670 4B Swiss chard 35.000000 1.000 1.000

05010610 5A Broccoli 12.000000 1.000 1.000

05010611 5 A Broccoli

- babyfood 12.000000 1.000 1.000
05010620 5A Broccoli, Chinese 12.000000 1.000 1.000
05010640 5A Brussels sprouts 12.000000 1.000 1.000 05010690 5A Cabbage 12.000000 1.000 1.000
05010710 5A Cabbage, Chinese, napa 12.000000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 12.000000 1.000 1.000

05010830 5A Cauliflower 12.000000 1.000 1.000

05011960 5A Kohlrabi 12.000000 1.000 1.000

05020630 5B Broccoli raab 60.000000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 60.000000 1.000 1.000

05021170 5B Collards 60.000000 1.000 1.000

05021940 5B Kale 60.000000 1.000 1.000
05022290 5B Mustard greens 60.000000 1.000 1.000 05023180 5B Rape greens 60.000000 1.000 1.000
05023890 5B Turnip, greens 60.000000 1.000 1.000 06010430 6A Bean, snap, succulent 0.056000 1.000 1.000 *
06010431 6A Bean, snap, succulent

- babyfood 0.056000 1.000 1.000 *
06020310 6B Bean, broad, succulent 0.056000 1.000 1.000 * 06020330 6B Bean, cowpea, succulent 0.056000 1.000 1.000 *
06020370 6B Bean, lima, succulent 0.056000 1.000 1.000 *
08001480 8 Eggplant 2.000000 1.000 1.000

08002340 8 Okra 2.000000 1.000 1.000 08002700 8 Pepper, bell 2.000000 1.000 1.000
08002701 8 Pepper, bell

- babyfood 2.00000 0 1.000 1.000 08002710 8 Pepper, bell, dried 2.000000 1.000 1.000
08002711 8 Pepper, bell, dried

- babyfood 2.000000 1.000 1.000 08002720 8 Pepper, nonbell 2.000000 1.000 1.000

08002721 8 Pepper, nonbell

- babyfood 2.000000 1.000 1.000 08002730 8 Pepper, nonbell, dried 2.000000 1.000 1.000

08003740 8 Tomatillo 2.000000 1.000 1.000

08003750 8 Tomato 2.000000 1.000 1.000

08003751 8 Tomato

- babyfood 2.000000 1.000 1.000 08003760 8 Tomato, paste 2.000000 1.200 1.000
08003761 8 Tomato, paste

- babyfood 2.000000 1.200 1.000

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 40 of 49 08003770 8 Tomato, puree 2.000000 1.200 1.000
08003771 8 Tomato, puree

- babyfood 2.000000 1.200 1.000
08003780 8 Tomato, dried 2.000000 14.300 1.000
08003781 8 Tomato, dried

- ba byfood 2.000000 14.300 1.000
08003790 8 Tomato, juice 2.000000 1.500 1.000
09010750 9A Cantaloupe 0.500000 1.000 1.000

09010800 9A Casaba 0.500000 1 .000 1.000 09011870 9A Honeydew melon 0.500000 1.000 1.000

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

09021350 9B Cucumber 0.500000 1.000 1.000
09023080 9B Pumpkin 0.500000 1.000 1.000 09023090 9B Pumpkin, seed 0.500000 1.000 1.000
09023560 9B Squash, summer 0.500000 1. 000 1.000 09023561 9B Squash, summer

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

- babyfood 0.500000 1.000 1.000

10001060 10 Citr us citron 2.500000 1.000 1.000 10001070 10 Citrus hybrids 2.500000 1.000 1.000
10001080 10 Citrus, oil 80.000000 1.000 1.000 10001800 10 Grapefruit 2.500000 1.000 1.000
10001810 10 Grapefruit, juice 2.500000 2.100 1.000
10001970 10 Kumquat 2.500000 1.000 1.000

10001990 10 Lemon 2.500000 1.000 1.000

10002 000 10 Lemon, juice 2.500000 2.000 1.000 10002001 10 Lemon, juice

- babyfood 2.500000 2.000 1.000
10002010 10 Lemon, peel 7.500000 1.000 1.000

10002060 10 Lime 2.500000 1.000 1.000
10002070 10 Lime, juice 2.500000 2.000 1.000 10002071 10 Lime, juice

- babyfood 2.500000 2.000 1.000
10002400 10 Orange 2.500000 1.000 1 .000 10002410 10 Orange, juice 2.500000 1.800 1.000
10002411 10 Orange, juice

- babyfood 2.500000 1.800 1.000 10002420 10 Orange, peel 7.500000 1.000 1.000

10003070 10 Pummelo 2.500000 1.000 1.000 10003690 10 Tangerine 2.500000 1.000 1.000
10003700 10 Tangerine, juice 2.500000 2.300 1.000 11000070 11 Apple, fruit with peel 8.400000 1.000 1.000 * 11000080 11 Apple, peeled fruit 8.400000 1.000 1.000 * 11000081 11 Apple, peeled fruit

- babyfood 8.400000 1.000 1.000 * 11000090 11 Apple, dried 8.400000 8.000 1.000 *

1 1000091 11 Apple, dried

- babyfood 8.400000 8.000 1.000 * 11000100 11 Apple, juice 8.400000 1.300 1.000 * 11000101 11 Apple, juice

- babyfood 8.400000 1.300 1.000 *
11000110 11 Apple, sauce 8.400000 1.000 1.000 * 11000111 11 Apple, sauce

- babyfood 8.400000 1.000 1.000 *
11001290 11 Crabapple 8.400000 1.000 1.000 *
11002100 11 Loquat 8.400000 1.000 1.000 *

11002660 11 Pear 16.800000 1.000 1.000 *

11002661 11 Pear

- babyfood 16.800000 1.000 1.000 *
11002670 11 Pear, dried 16.800000 6.250 1.000 * 11002680 11 Pear, juice 16.800000 1.000 1.000 * 11002681 11 Pear, juice

- babyfood 16.800000 1.000 1.000 *
11003100 11 Quince 8.400000 1.000 1.000 * 12000120 12 Apricot 25.200000 1.000 1.000 * 12000121 12 Apricot

- babyfood 25.200000 1.000 1.000 * 12000130 12 Apricot, dried 25.200000 6.000 1.000 * 12000140 12 Apricot, juice 25.20000 0 1.000 1.000 * 12000141 12 Apricot, juice

- babyfood 25.200000 1.000 1.000 *
12000900 12 Cherry 5.320000 1.000 1.000 * 12000901 12 Cherry

- babyfood 5.320000 1.000 1.000 *

12000910 12 Cherry, juice 5.320000 1.500 1.000 * 12000911 12 Cherry, juice

- babyfood 5.320000 1.500 1.000 *

12002300 12 Nectarine 25.200000 1.000 1.000 *

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 41 of 49 12002600 12 Peach 25.200000 1.000 1.000 *

12002601 12 Peach

- babyfood 25.200000 1.000 1.000 *
12002610 12 Peach, dried 25.200000 7.000 1.000 *
12002611 12 Peach, dried

- b abyfood 25.200000 7.000 1.000 * 12002620 12 Peach, juice 25.200000 1.000 1.000 * 12002621 12 Peach, juice

- babyfood 25.200000 1.000 1.000 *

12002850 12 Plum 5.320000 1.000 1.000 *

12002851 12 Plum

- babyfood 5.320000 1.000 1.000 *
12002860 12 Plum, prune, fresh 5.320000 1.000 1.000 * 12002861 12 Plum, prune, fresh

- babyfood 5.320000 1.000 1.000 *

1 2002870 12 Plum, prune, dried 5.320000 5.000 1.000 * 12002871 12 Plum, prune, dried

- babyfood 5.320000 5.000 1.000 * 12002880 12 Plum, prune, juice 5.320000 1.400 1.000 * 12002881 12 Plum, prune, ju ice

- babyfood 5.320000 1.400 1.000 *
13020570 13B Blueberry 2.500000 1.000 1.000 13020571 13B Blueberry

- babyfood 2.500000 1.000 1.000

14000030 14 Almond 0.050000 1.000 1.000

14000031 14 Almond

- babyfood 0.050000 1.000 1.000
14000040 14 Almond, oil 0.050000 1.000 1.000
14000041 14 Almond, oil

- babyfood 0.050000 1.000 1.000

14000590 14 B razil nut 0.050000 1.000 1.000

14000680 14 Butternut 0.050000 1.000 1.000

14000810 14 Cashew 0.050000 1.000 1.000

14000920 14 Chestnut 0.050000 1.000 1.000

14001550 14 Filbert 0.050000 1.000 1.000
14001560 14 Filbert, oil 0.050000 1.000 1.000 14001850 14 Hickory nut 0.050000 1.000 1.000

14002130 14 Macadamia nut 0.050000 1.000 1.000

14002690 14 Pecan 0.050000 1.000 1.000

14002820 14 Pistachio 0.050000 1.000 1.000

14003910 14 Walnut 0.050000 1.000 1.000
21000440 M Beef, meat 0.015000 1.000 1.000
21000441 M Beef, meat

- babyfood 0.015000 1.000 1.000
21000450 M Beef, meat, dried 0.015000 1. 920 1.000 21000460 M Beef, meat byproducts 0.025000 1.000 1.000
21000461 M Beef, meat byproducts

- babyfood 0.025000 1.000 1.000
21000470 M Beef, fat 0.025000 1.000 1.000

21000471 M Beef ,fat

- babyfood 0.025000 1.000 1.000 21000480 M Beef, kidney 0.015000 1.000 1.000
21000490 M Beef, liver 0.015000 1.000 1.000
21000491 M Beef, liver

- babyfood 0.015000 1.000 1.000
23001690 M Goat, meat 0.015000 1.000 1.000 23001700 M Goat, meat byproducts 0.025000 1.000 1.000
23001710 M Goat, fat 0.025000 1.000 1.000

23001 720 M Goat, kidney 0.015000 1.000 1.000
23001730 M Goat, liver 0.015000 1.000 1.000
24001890 M Horse, meat 0.015000 1.000 1.000
25002900 M Pork, meat 0.015000 1.000 1.000
25002901 M Pork, meat

- babyfood 0.015000 1.000 1.000
25002910 M Pork, skin 0.015000 1.000 1.000
25002920 M Pork, meat byproducts 0.025000 1.000 1.000 25002921 M Pork, meat byproducts

- babyfood 0.025000 1.000 1.000
25002930 M Pork, fat 0.025000 1.000 1.000
25002931 M Pork, fat

- babyfood 0.025000 1.000 1.000
25002940 M Pork, kid ney 0.015000 1.000 1.000
25002950 M Pork, liver 0.015000 1.000 1.000
26003390 M Sheep, meat 0.015000 1.000 1.000 26003391 M Sheep, meat

- babyfood 0.015000 1.000 1.000
26003400 M Sheep, meat byproducts 0.025000 1.000 1.000 26003410 M Sheep, fat 0.025000 1.000 1.000
26003411 M Sheep, fat

- babyfo od 0.025000 1.000 1.000 26003420 M Sheep, kidney 0.015000 1.000 1.000
26003430 M Sheep, liver 0.015000 1.000 1.000
27002220 D Milk, fat 0.080000 1. 000 1.000
27002221 D Milk, fat

- baby food/infant for 0.080000 1.000 1.000
28002210 M Meat, game 0.015000 1.000 1.000
29003120 M Rabbit, meat 0.015000 1.000 1.000

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 42 of 49 86010000 O Wate r, direct, all sources 0.058200 1.000 1.000
86020000 O Water, indirect, all sources 0.058200 1.000 1.000

95000010 O Acerola 0.840000 1.000 1.000 *

95000200 O Avocado 0.840000 1.000 1.000 *

95000230 O Banana 0.200000 1.000 1.000

95000231 O Banana

- babyfood 0.200000 1.000 1.000
95000240 O Banana, dried 0.200000 3.900 1.000

950 00241 O Banana, dried

- babyfood 0.200000 3.900 1.000

95000740 O Canistel 0.900000 1.000 1.000 95000890 O Cherimoya 0.840000 1.000 1.000 *
95001150 O Coffee, roasted bea n 0.350000 1.000 1.000
95001160 O Coffee, instant 0.350000 1.000 1.000
95001280 O Cottonseed, oil 0.350000 1.000 1.000
95001281 O Cottonseed, oil

- babyfood 0.350000 1.00 0 1.000
95001300 O Cranberry 2.500000 1.000 1.000 95001301 O Cranberry

- babyfood 2.500000 1.000 1.000
95001310 O Cranberry, dried 2.500000 1.000 1.000 95001320 O Cranberry, juice 2.500000 1.100 1.000
95001321 O Cranberry, juice

- babyfood 2.500000 1.100 1.000 95001510 O Feijoa 0.840000 1.000 1.000 *
95001750 O Grape 7.000000 1.000 1.000 * 95001760 O Grape, juice 7.000000 1.200 1.000 * 95001761 O Grape, juice

- babyfood 7.000000 1.200 1.000 * 95001770 O Grape, leaves 7.000000 1.000 1.000 * 95001780 O Grape, raisin 7.000000 4.300 1.000 * 95001790 O Grape, wine and sherry 7.000000 1.200 1.000 *

95001830 O Guava 0.840000 1.000 1.000 *

95001831 O Guava

- babyfood 0.840000 1.000 1.000 *

95001920 O Jaboticaba 0.840000 1.000 1.000 *
95002090 O Longan 0.840000 1.000 1.000 * 95002110 O Lychee 0.840000 1.000 1.000 * 95002120 O Lychee, dried 0.840000 1.850 1.000 *
95002150 O Mango 0.900000 1.000 1.000
95002151 O Mango

- babyfood 0.900000 1.000 1.000 95002160 O Mango, dried 0.900000 1.000 1.000
95002170 O Mango, juice 0.900000 1.000 1.000 95002171 O Mango, juice

- babyfood 0.900000 1.000 1.000

95002350 O Olive 9.800000 1.000 1.000 *
95002360 O Olive, oil 13.400000 1.000 1.000 *
95002450 O Papaya 0.900000 1.000 1.000 95002451 O Papaya

- babyfood 0.900000 1.000 1.000
95002460 O Papaya, dried 0.900000 1.800 1.000 95002470 O Papaya, juice 0.900000 1.500 1.000

95002520 O Passionfruit 0.840000 1.000 1.000 *

95002521 O Passionfruit

- babyfood 0.840000 1.000 1.000 * 95002530 O Passionfruit, juice 0.840000 1.000 1.000 * 95002531 O Passionfruit, juice

- babyfood 0.840000 1.000 1.000 *

95002770 O Persimmon 5.320000 1.000 1.000 *

95002830 O Plantain 0.200000 1.000 1.000
95002840 O Plantain, dried 0.200000 3.900 1.000
95002890 O Pomegranate 1.900000 1.000 1.000 95003330 O Sapote, Mamey 0.900000 1.000 1.000 95003460 O Soursop 0.840000 1.000 1.000 * 95003510 O Spanish lime 0.840000 1.000 1.000 *

95003580 O Starfruit 0.840000 1.000 1.000 *
95003590 O Strawberry 2.500000 1.000 1.000
95003591 O Strawberry

- babyfood 2.500000 1.000 1.000

95003600 O Strawberry, juice 2.500000 1.000 1.000
95003601 O Strawberry, juice

- babyfood 2.500000 1.000 1.000 95003610 O Sugar apple 0.840000 1.000 1.000 *
95003720 O Tea, dried 20.000000 1.000 1.000
95003730 O Tea, instant 20.000000 1.000 1.000



### * Bolded Entry Includes Anticipated Residue Incorporates a BF4 Conjugate Factor (1.8x)

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 43 of 49 Attachment 5 : DEEM

- FCID A cute E xposure E stimates

U.S. Environmental Protection Agency Ver. 2.02

DEEM

- FCID ACUTE Analysis for BUPROFEZIN (1994

- 98 data)

Residue file: 275100a5

- 31

- 12.R98 Adjus tment factor #2 used.
Analysis Date: 05

- 31

- 2012/11:48:05 Residue file dated: 05

- 31

- 2012/11:46:33/8 NOEL (Acute) = 200.000000 mg/kg body

- wt/day
Daily totals for food and foodform consumption used. Run Comment: "acute endpoint for females 13

- 50 years old only"

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

Summary calculations (per capita):

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

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Females 13

- 49 yrs:

0.098734 4.94 2025 0.172750 8.64 1157 0.266520 13.33 750

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 44 of 49 Attachment 6 : DEEM

- FCID Chronic Residue File

Filename: C: \ Documents and Settings \ bkohllig \ My Documents \ 275100c5

- 31

- 12.R98
Chemical: buprofezin RfD(Chronic): .0033 mg/kg bw/day NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): 2 mg/kg bw/day NOEL(Acute): 200 mg/kg bw/day
Date created/last modified: 05

- 31

- 2012/12:04:08/8 Program ver. 2.03
Comment: FTD=Average Field Trial Data; PDP=PDP Monitoring Data; Tol=Tolerance

*=Factor for BF4 Conjugates Used

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

-------- ---- -------------------------- ----- ---------- ------ ------ ------- 04010050 4A Amaranth, leafy 7.180000 1.000 1.000 FTD 04010180 4A Arugula 7.180000 1.000 1.000 FTD
04011040 4A Chrysanthemum, garland 7.180000 1.000 1.000 FTD 04011330 4A Cress, garden 7.180000 1.000 1.000 FTD
04011340 4A Cress, upland 7.180000 1.000 1.000 FTD
04011380 4A Dandelion, leaves 7.180000 1.000 1.000 FTD

04 011500 4A Endive 7.180000 1.000 1.000 FTD
04012040 4A Lettuce, head 0.017800 1.000 0.010 PDP
04012050 4A Lettuce, leaf 0.017800 1.000 0.010 PDP 04012480 4A Parsley, l eaves 7.180000 1.000 1.000 FTD

04013130 4A Radicchio 1.990000 1.000 1.000 FTD 04013550 4A Spinach 0.017800 1.000 0.300 PDP
04013551 4A Spinach

- babyfood 0.017800 1.000 0.300 PDP

04020760 4B Cardoon 4.100000 1.000 1.000 FTD
04020850 4B Celery 4.100000 1.000 0.180 FTD
04020851 4B Celery

- babyfood 4.100000 1.000 0 .180 FTD 04020860 4B Celery, juice 4.100000 1.000 0.180 FTD

04020870 4B Celtuce 4.100000 1.000 1.000 FTD
04021520 4B Fennel, Florence 4.100000 1.000 1.000 FTD

04023220 4B Rhubarb 4.100000 1.000 1.000 FTD

04023670 4B Swiss chard 4.100000 1.000 1.000 FTD

05010610 5A Broccoli 1.030000 1.000 0.550 FTD

05010611 5A Broccoli

- babyfood 1.030000 1.000 0.550 FTD
05010620 5A Broccoli, Chinese 1.030000 1.000 0.550 FTD
05010640 5A Brussels sprouts 0.079000 1.000 0.610 FTD
05010690 5A Cabbage 0.079000 1.000 0.400 FTD 05010710 5A Cabbage, Chinese, napa 1.030000 1.000 1.000 FTD
05010720 5A Cabbage, Chinese, mustard 1.030000 1.000 1.000 FTD

05010830 5A Cauliflower 1.030000 1.000 0.480 FTD

05011960 5A Kohlrabi 1.030000 1.000 0.050 FTD

05020630 5B Broccoli raab 20.000000 1.000 1.000 FTD
05020700 5B Cabbage, Chinese, bok choy 20.000000 1.000 1.000 FTD

05021170 5 B Collards 20.000000 1.000 1.000 FTD

05021940 5B Kale 20.000000 1.000 1.000 FTD 05022290 5B Mustard greens 20.000000 1.000 1.000 FTD
05023180 5B Rape greens 20.000000 1.000 1.000 FTD 05023890 5B Turnip, greens 20.000000 1.000 1.000 FTD 06010430 6A Bean, snap, succulent 0.056000 1.000 1.000 Tol *
06010431 6A Bean, snap, succulent

- babyfood 0.056000 1.000 1.000 Tol *
06020310 6B Bean, broad, succulent 0.056000 1.000 1.000 Tol *
06020330 6B Bean, cowpea, succulent 0.056000 1.000 1.000 Tol *
06020370 6B Bean, lima, succulent 0.056000 1.000 1 .000 Tol *
08001480 8 Eggplant 0.560000 1.000 1.000 FTD

08002340 8 Okra 0.560000 1.000 1.000 FTD
08002700 8 Pepper, bell 0.340000 1.000 1.000 FTD
08002701 8 Pepper, bell

- babyfood 0.340000 1.000 1.000 FTD
08002710 8 Pepper, bell, dried 0.340000 1.000 1.000 FTD 08002711 8 Pepper, bell, dried

- babyfood 0.340000 1.000 1.000 FTD
08002720 8 Pepper, nonbell 0.560000 1.000 1.000 FTD 08002721 8 Pepper, nonbell

- babyfood 0.560000 1.000 1.000 FTD
08002730 8 Pepper, nonbell, dried 0.560000 1.000 1.000 FTD

08003740 8 Tomatillo 0.129000 1.000 1.000 FTD

08003750 8 Tomato 0.129000 1.000 0.025 FTD

08003751 8 Tomato

- babyfood 0.129000 1.000 0.025 FTD
08003760 8 Tomato, paste 0.129000 1.200 0.025 FTD

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 45 of 49 08003761 8 Tomato, paste

- babyfood 0.129000 1.200 0.025 FTD
08003770 8 Tomato, puree 0.129000 1.200 0.025 FTD
08003771 8 Tomato, puree

- babyfood 0.129000 1.200 0.025 FTD

08003780 8 Tomato, dried 0.129000 14.300 0.025 FTD
08003781 8 Tomato, dried

- babyfood 0.129000 14.300 0.025 FTD 08003790 8 Tomato, juice 0.129000 1.500 0.025 FTD
09010750 9A Cantaloupe 0.150000 1.000 0.050 FTD

09010800 9A Casaba 0.150000 1.000 1.000 FTD
09011870 9A Honeydew melon 0.150000 1.000 0.025 FTD

09013990 9A Watermelon 0.150 000 1.000 0.025 FTD
09014000 9A Watermelon, juice 0.150000 1.000 0.025 FTD
09020210 9B Balsam pear 0.136000 1.000 1.000 FTD
09020880 9B Chayote, fruit 0.136000 1.000 1.000 FT D 09021020 9B Chinese waxgourd 0.136000 1.000 1.000 FTD

09021350 9B Cucumber 0.082000 1.000 1.000 FTD 09023080 9B Pumpkin 0.136000 1.000 0.010 FTD
09023090 9B Pumpki n, seed 0.136000 1.000 0.010 FTD 09023560 9B Squash, summer 0.136000 1.000 0.010 FTD
09023561 9B Squash, summer

- babyfood 0.136000 1.000 0.010 FTD 09023570 9B Squash, winter 0.136000 1.000 0.010 FTD
09023571 9B Squash, winter

- babyfood 0.136000 1.000 0.010 FTD

10001060 10 Citrus citron 1.240000 1.000 1.000 FTD

10001070 10 Citrus h ybrids 1.240000 1.000 1.000 FTD
10001080 10 Citrus, oil 80.000000 1.000 0.025 Tol 10001800 10 Grapefruit 0.006600 1.000 0.010 PDP * 10001810 10 Grapefruit, juice 0.006600 2.100 0.010 PDP *
10001970 10 Kumquat 1.240000 1.000 1.000 FTD

10001990 10 Lemon 0.021900 1.000 0.025 PDP * 10002000 10 Lemon, juice 0.021900 2.0 00 0.025 PDP * 10002001 10 Lemon, juice

- babyfood 0.021900 2.000 0.025 PDP * 10002010 10 Lemon, peel 0.072300 1.000 0.025 PDP*

10002060 10 Lime 1.240000 1.000 1.000 FTD

1000 2070 10 Lime, juice 1.240000 2.000 1.000 FTD
10002071 10 Lime, juice

- babyfood 1.240000 2.000 1.000 FTD 10002400 10 Orange 0.021900 1.000 0.025 PDP * 10002410 10 Orange, jui ce 0.021900 1.800 0.025 PDP * 10002411 10 Orange, juice

- babyfood 0.021900 1.800 0.025 PDP *
10002420 10 Orange, peel 0.072300 1.000 0.025 PDP *

10003070 10 Pummelo 1.240000 1.000 1.000 FTD
10003690 10 Tangerine 1.240000 1.000 1.000 FTD 10003700 10 Tangerine, juice 1.240000 2.300 1.000 FTD 11000070 11 Apple, fruit with peel 0.009500 1.000 0.050 PDP * 11000080 11 Apple, peeled fruit 0.009500 1.000 0.050 PDP * 11000081 11 Apple, peeled fruit

- babyfood 0.009500 1.000 0.050 PDP * 11000090 11 Apple, dried 0.009500 8.000 1.000 PDP * 11000091 11 Apple, dried

- babyfood 0.009500 8.000 1.000 PDP * 11000100 11 Apple, juice 0.009500 1.300 0.050 PDP * 11000101 11 Apple, juice

- babyfood 0.009500 1.300 0.050 PDP * 11000110 11 Apple, sauce 0.006200 1.000 0.050 PDP *
11000111 11 Apple, sauce

- babyfood 0.006200 1.000 0.050 PDP *
11001290 11 Crabapple 3.020000 1.000 1.000 FTD * 11002100 11 Loqua t 3.020000 1.000 1.000 FTD *

11002660 11 Pear 0.075000 1.000 0.150 PDP *

11002661 11 Pear

- babyfood 0.075000 1.000 0.150 PDP *
11002670 11 Pear, dried 0.075000 6.250 1.000 PDP * 11002680 11 Pear, juice 0.075000 1.000 0.150 PDP * 11002681 11 Pear, juice

- babyfood 0.075000 1.000 0.150 PDP *
11003100 11 Quince 3.020000 1.000 1.000 FTD * 12000120 12 Apricot 4.700000 1.000 0.510 FTD * 12000121 12 Apricot

- babyfood 4.700000 1.000 0.510 FTD * 12000130 12 Apricot, dried 4.700000 6.000 0.510 FT D * 12000140 12 Apricot, juice 4.700000 1.000 0.510 FTD * 12000141 12 Apricot, juice

- babyfood 4.700000 1.000 0.510 FTD * 12000900 12 Cherry 1.960000 1.000 0.720 FTD *
12000901 12 Cherry

- babyfood 1.960000 1.000 0.720 FTD * 12000910 12 Cherry, juice 1.960000 1.500 0.720 FTD * 12000911 12 Cherry, juice

- babyfood 1.960000 1.500 0.720 FTD *

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 46 of 49 12002300 12 Necta rine 4.700000 1.000 0.510 FTD *

12002600 12 Peach 0.021000 1.000 0.130 PDP *

12002601 12 Peach

- babyfood 0.021000 1.000 0.130 PDP *
12002610 12 Peach, dried 0.021000 7.000 1.000 PDP *
12002611 12 Peach, dried

- babyfood 0.021000 7.000 1.000 PDP * 12002620 12 Peach, juice 0.021000 1.000 0.130 PDP * 12002621 12 Peach, juice

- babyfood 0.021000 1.000 0.130 PDP *

12002850 12 Plum 0.540000 1.000 0.370 FTD *

12002851 12 Plum

- babyfood 0.540000 1.000 0.370 FTD * 12002860 12 Plum, prune, fresh 0.540000 1.000 0.370 FTD *
12002861 12 Plum, prune, fresh

- babyfood 0.540000 1.000 0.370 FTD * 12002870 12 Plum, prune, dried 0.540000 5.000 0.370 FTD * 12002871 12 Plum, prune, dried

- babyfood 0.540000 5.000 0.370 FTD *

12002880 12 Plum, prune, juice 0.540000 1.400 0.370 FTD * 12002881 12 Plum, prune, juice

- babyfood 0.540000 1.400 0.370 FTD *
13020570 13B Blueberry 0.580000 1.000 1.000 FTD
13020571 13B Blueberry

- babyfood 0.580000 1.000 1.000 FTD

14000030 14 Almond 0.050000 1.000 0.010 Tol

14000031 14 Almond

- babyfood 0.050000 1.000 0.010 Tol
14000040 14 Almond, oil 0.050 000 1.000 0.010 Tol
14000041 14 Almond, oil

- babyfood 0.050000 1.000 0.010 Tol

14000590 14 Brazil nut 0.050000 1.000 1.000 Tol

14000680 14 Butternut 0.050000 1.000 1.000 To l

14000810 14 Cashew 0.050000 1.000 1.000 Tol

14000920 14 Chestnut 0.050000 1.000 1.000 Tol

14001550 14 Filbert 0.050000 1.000 1.000 Tol

14001560 14 Filber t, oil 0.050000 1.000 1.000 Tol
14001850 14 Hickory nut 0.050000 1.000 1.000 Tol

14002130 14 Macadamia nut 0.050000 1.000 1.000 Tol

14002690 14 Pecan 0.050000 1.000 1.000 Tol

14002820 14 Pistachio 0.050000 1.000 0.050 Tol

14003910 14 Walnut 0.050000 1.000 1.000 Tol
21000440 M Beef, meat 0.015000 1.00 0 1.000 FTD
21000441 M Beef, meat

- babyfood 0.015000 1.000 1.000 FTD
21000450 M Beef, meat, dried 0.015000 1.920 1.000 FTD
21000460 M Beef, meat byproducts 0.025000 1.000 1.000 FTD 21000461 M Beef, meat byproducts

- babyfood 0.025000 1.000 1.000 FTD
21000470 M Beef, fat 0.025000 1.000 1.000 FTD
21000471 M Beef,fat

- babyfood 0.025000 1.000 1.000 FTD
21000480 M Beef, ki dney 0.015000 1.000 1.000 FTD
21000490 M Beef, liver 0.015000 1.000 1.000 FTD
21000491 M Beef, liver

- babyfood 0.015000 1.000 1.000 FTD
23001690 M Goat, meat 0.015000 1.000 1.000 FTD
23001700 M Goat, meat byproducts 0.025000 1.000 1.000 FTD
23001710 M Goat, fat 0.025000 1.000 1.000 FTD
23001720 M Goat, kidney 0.015000 1.000 1.000 FTD
23001730 M Goat, liver 0.015000 1.000 1.000 FTD
24001890 M Horse, meat 0.015000 1.000 1.000 FTD
25002900 M Pork, meat 0.015000 1.000 1.000 FTD

25002901 M Pork, meat

- babyfood 0.015000 1.000 1.000 FTD
25002910 M Pork, skin 0.015000 1.000 1.000 FTD
25002920 M Pork, meat byproducts 0.025000 1.000 1.000 FTD
25002921 M Pork, meat byprodu cts

- babyfood 0.025000 1.000 1.000 FTD
25002930 M Pork, fat 0.025000 1.000 1.000 FTD
25002931 M Pork, fat

- babyfood 0.025000 1.000 1.000 FTD 25002940 M Pork, kidney 0.015 000 1.000 1.000 FTD
25002950 M Pork, liver 0.015000 1.000 1.000 FTD
26003390 M Sheep, meat 0.015000 1.000 1.000 FTD
26003391 M Sheep, meat

- babyfood 0.015000 1.000 1.000 FT D 26003400 M Sheep, meat byproducts 0.025000 1.000 1.000 FTD
26003410 M Sheep, fat 0.025000 1.000 1.000 FTD 26003411 M Sheep, fat

- babyfood 0.025000 1.000 1.000 FTD
26003420 M Sheep, kidney 0.015000 1.000 1.000 FTD 26003430 M Sheep, liver 0.015000 1.000 1.000 FTD
27002220 D Milk, fat 0.080000 1.000 1.000 FTD
27002221 D Milk, fat

- baby food/infant for 0.080000 1.000 1.000 FTD
28002210 M Meat, game 0.015000 1.000 1.000 FTD

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 47 of 49 29003120 M Rabbit, meat 0.015000 1.000 1.000 FTD
86010000 O Water, d irect, all sources 0.018600 1.000 1.000 PRZM
86020000 O Water, indirect, all sources 0.018600 1.000 1.000 PRZM

95000010 O Acerola 0.840000 1.000 1.000 Tol *

95000200 O Avocado 0.840000 1.000 1.000 Tol *

95000230 O Banana 0.007500 1.000 1.000 PDP

95000231 O Banana

- babyfood 0.007500 1.000 1.000 PDP
95000240 O Banana, dried 0.007500 3. 900 1.000 PDP
95000241 O Banana, dried

- babyfood 0.007500 3.900 1.000 PDP

95000740 O Canistel 0.590000 1.000 1.000 FTD 95000890 O Cherimoya 0.840000 1.000 1.000 Tol *

95001 150 O Coffee, roasted bean 0.130000 1.000 1.000 FTD
95001160 O Coffee, instant 0.130000 1.000 1.000 FTD
95001280 O Cottonseed, oil 0.350000 1.000 0.010 Tol
95001281 O Cottonseed, o il

- babyfood 0.350000 1.000 0.010 Tol 95001300 O Cranberry 0.580000 1.000 1.000 FTD
95001301 O Cranberry

- babyfood 0.580000 1.000 1.000 FTD 95001310 O Cranberry, dried 0.580000 1.000 1.000 FTD
95001320 O Cranberry, juice 0.580000 1.100 1.000 FTD 95001321 O Cranberry, juice

- babyfood 0.580000 1.100 1.000 FTD 95001510 O Feijoa 0.840000 1.000 1.00 0 Tol * 95001750 O Grape 0.013000 1.000 0.150 PDP * 95001760 O Grape, juice 0.013000 1.200 0.150 PDP * 95001761 O Grape, juice

- babyfood 0.013000 1.200 0.150 PDP *
95001770 O Grape, leaves 0.013000 1.000 0.150 PDP * 95001780 O Grape, raisin 0.013000 4.300 0.150 PDP * 95001790 O Grape, wine and sherry 0.013000 1.200 0.150 PDP *

95001830 O Guava 0.840000 1.000 1.000 Tol *

95001831 O Guava

- babyfood 0.840000 1.000 1.000 Tol *

95001920 O Jaboticaba 0.840000 1.000 1.000 Tol * 95002090 O Longan 0.840000 1.000 1.000 Tol *
95002110 O Lychee 0.840000 1.000 1.000 Tol * 95002120 O Lychee, dried 0.840000 1.850 1.000 Tol *
95002150 O Mango 0.590000 1.000 1.000 FTD 95002151 O Mango

- babyfood 0.590000 1.000 1.000 FTD
95002160 O Mango, dried 0.590000 1.000 1.000 FTD 95002170 O Mango, juice 0.590000 1.000 1.000 FTD

9 5002171 O Mango, juice

- babyfood 0.590000 1.000 1.000 FTD

95002350 O Olive 3.000000 1.000 1.000 FTD *
95002360 O Olive, oil 9.000000 1.000 1.000 FTD *
95002450 O Papaya 0.590000 1.000 1.000 FTD
95002451 O Papaya

- babyfood 0.590000 1.000 1.000 FTD 95002460 O Papaya, dried 0.590000 1.800 1.000 FTD
95002470 O Papaya, juice 0.590000 1.500 1.000 FTD

95002520 O Passionfruit 0.840000 1.000 1.000 Tol *

95002521 O Passionfruit

- babyfood 0.840000 1.000 1.000 Tol * 95002530 O Passionfruit, juice 0.840000 1.000 1.000 Tol * 95002531 O Passionfruit, juice

- babyfood 0.840000 1.000 1.000 Tol *

95002770 O Persimmon 0.540000 1.000 1.000 FTD *

95002830 O Plantain 0.007500 1.000 1.000 PDP

9 5002840 O Plantain, dried 0.007500 3.900 1.000 PDP
95002890 O Pomegranate 0.194000 1.000 1.000 FTD
95003330 O Sapote, Mamey 0.590000 1.000 1.000 FTD 95003460 O Soursop 0.840000 1.000 1.000 Tol * 95003510 O Spanish lime 0.840000 1.000 1.000 Tol *

95003580 O Starfruit 0.840000 1.000 1.000 Tol *

95003590 O Straw berry 0.009300 1.000 0.390 PDP * 95003591 O Strawberry

- babyfood 0.009300 1.000 0.390 PDP * 95003600 O Strawberry, juice 0.009300 1.000 0.390 PDP * 95003601 O Strawberry, juice

- babyfo od 0.009300 1.000 0.390 PDP *
95003610 O Sugar apple 0.840000 1.000 1.000 Tol *
95003720 O Tea, dried 20.000000 1.000 1.000 Tol
95003730 O Tea, instant 20.000000 1.000 1.000 Tol



### * Bolded Entry Includes Anticipated Residue Incorporates a BF4 Conjugate Factor (1.8x)

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 48 of 49 Attachment 7 : DEEM

- FCID C hronic E xposure E stimates

U.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chronic analysis for BUPROFEZIN (1994

- 98 data)

Residue file name: C: \ Buprofezin \ 275100c5

- 31

- 12.R98 Adjustment factor #2 used.
Analysis Date 05

- 31

- 2012/12:04:29 Residue file dated: 05

- 31

- 2012/12:04:08/8 Reference dose (RfD, Chronic) = .0033 mg/kg bw/day

COMMENT 1:

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

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

Total Exposure

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

-------------------------------------- ------------- --------------- U.S. Population (total) 0.001675 50.8%

U.S. Po pulation (spring season) 0.001639 49.7%
U.S. Population (summer season) 0.001834 55.6% U.S. Population (autumn season) 0.001697 51.4%
U.S. Population (winter season) 0.001518 46.0%

Northeast region 0.001609 48.8% Midwest region 0.001457 44.1%
Southern region 0.001843 55.8% Western region 0.001703 51.6%

Hispanics 0.001265 38.3%

Non

- hispanic whites 0.001285 38.9%

Non

- hispanic blacks 0.003589 108.8%

Non

- hisp/non

- white/non

- black 0.003615 109.5%

All infants (< 1 year) 0.002240 67.9%
Nursing infants 0.000921 27.9%

Non

- nursing infants 0.002741 83.1%

Children 1

- 6 yrs 0.002725 82.6%

Children 7

- 12 yrs 0.001426 43.2%

Females 13

- 19 (not preg o r nursing) 0.001197 36.3%
Females 20+ (not preg or nursing) 0.001696 51.4%

Females 13

- 50 yrs 0.001427 43.2% Females 13+ (preg/not nursing) 0.001172 35.5% Females 13+ (nursing) 0.001126 34.1%

Males 13

- 19 yrs 0.001539 46.6%
Males 20+ yrs 0.001507 45.7%

Seniors 55+ 0.001968 59.6%

Children 1

- 2 yrs 0.002999 90.9%

Children 3

- 5 yrs 0.002714 82.3%

Children 6

- 12 yrs 0.00154 5 46.8%

Youth 13

- 19 yrs 0.001370 41.5%

Adults 20

- 49 yrs 0.001428 43.3% Adults 50+ yrs 0.001896 57.5%

Females 13

- 49 yrs 0.001424 43.1%

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

### Buprofezin (PC Code 275100) Dietary Exposure and Risk Assessment DP# s 400883 and 401716



## Page 4 9 of 49 Attachment 8 : Critical Commodity Analysis for Children 1

- 2 years old (chronic)

U.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chronic analysis for BUPROFEZIN (1994

- 98 data)

Residue file name: C: \ Buprofezin \ 275100c5

- 31

- 12.R98
Adjustment f actor #2 used.
Analysis Date 05

- 31

- 2012/12:05:52 Residue file dated: 05

- 31

- 2012/12:04:08/8 Reference dose (RfD, Chronic) = .0033 mg/kg bw/day

COMMENT 1:

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

C ritical Commodity Contribution Analysis for

Children 1

- 2 yrs

Total Exposure =.0029991 mg/kg bw/day

Crop groups with total exposure contribution > 5% Foods/Foodforms with exposure c ontribution > 3%

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

Crop group

---------- Exposure Analysis

------- Food mg/kg % of Total Percent Foodform body wt/day Exposure of RfD

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

Crop Group = (O) Other
Water, direct, all sources (86010000):
FoodForm N/S 0.0003466 11.56% 10.50%
Water, indirect, all sources (86020000):
FoodForm N/S 0.0002356 7.86% 7.14%

-------------------------------------- ----------- ---------- --------- Total for crop grou p 0.0009240 30.81% 28.00%

Crop Group = (D) Dairy Products
Milk, fat (27002220):
FoodForm N/S 0.0001149 3.83% 3.48%

-------------------------------------- ----------- ---------- --------- Total for crop group 0.0001150 3.84% 3.49%

Crop Group = (5A) Brassica: Head and Stem
Broccoli (05010610):
FoodForm N/S 0.0001386 4.62% 4.20%

--------------------------- ----------- ----------- ---------- --------- Total for crop group 0.0001656 5.52% 5.02%

Crop Group = (5B) Brassica: Leafy Greens
Collards (05021170):
FoodForm N/S 0.0005359 17.87% 16.24%
Turnip, greens (05023890):
FoodForm N/S 0.0002414 8.05% 7.32%

-------------------------------------- ----------- ---------- -------- - Total for crop group 0.0009303 31.02% 28.19%

Crop Group = (12) Stone Fruits
Apricot, dried (12000130):
FoodForm N/S 0.0001769 5.90% 5.36%

-------------------------------------- ----------- ---------- --------- Total for crop group 0.0004311 14.37% 13.06%