Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

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Page 1 of 29 

### 430736

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND

POLLUTION PREVENTION



### MEMORANDUM

Date: December 23, 2 015

SUBJECT: Emamectin Benzoate : Acute and Chronic Aggregate D ietary (Food and

Drinking Water) Exposure and Risk Assessment s using Updated Percent

Crop Treated

.

PC Code: 122806 DP Barcode: D 430736

Decision No.: 495169 Registration No. : NA

Petition No.: NA Regulatory Action: Section 3 Registration

Risk Assessment Type : Dietary Case No .: NA

TXR No .: NA CAS No s .: 155569

- 91

- 8 (emamectin benzoate)

119791

- 41

- 2 (emamectin )

MRID No .: NA 40 CFR: § 180.505

FROM : Nancy Dodd, Chemist

R isk Assessment Branch III (RAB3)

Health Effects Division ( HED; 7509P)

THROUGH: David Hrdy, Senior Scientist

Jennifer R. Tyler, Chemist

Dietary Exposure Science Advisory Council (DESAC)

H ED (7509P)

and

Christine Olinger, Branch Chief

RAB3/HED (7509P)

TO: Meredith Laws, Branch Chief

Mark Suarez / Jessica Rogala , R M#7

Invertebrate and Vertebrate Branch 3

Registration D ivision ( RD; 7 505 P)Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

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Page 2 of 29 

### Executive Summary

Acute and c hronic aggregate dietary (food and drinking water ) exposure and risk

assessments were conducted using the Dietary E xposure Evaluation Model software with

the Food Commodity Intake Database (DEEM

- FCID), Version 3.16. This software use s

2003

- 2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s)

National Health and Nutrition Examination Survey, What We Eat in America

(NHA NES/WWEIA). The analyses were conducted using updated percent crop treated

data dated 7/15/15 in support of a screening assessment of combined residues of

abamectin and emamectin to support a human health risk assessment on abamectin

(D 42 3301

, L. Nollen, 04/18 /16). No other changes were made to the prior emamectin

input files. Thi s memorandum was reviewed by two peer reviewers of the DESAC, per

the current DESAC Standard Operating Procedure (SOP).

Acute Dietary ( Food and Drinking Water ) E xposure Results and Characterization

A probabilistic acute dietary exposure assessment was conducted

. The anticipated

residue estimates , used for most cr ops, were based on field trial data

. Tolerance

- level

residues were used for tree nuts

, cottonseed oil , and wine

. Pesticide Data Program (PDP)

monitoring data for years 2009 and 2010 were used for apples since apple juice had a

significant impact on exposure. DEEM default processing factors were used except for

commodities with chemical

- specific processing stu dies. P ercent crop treated ( P CT or %

CT ) data provided by the Biological and Economic Analysis Division ( BEAD ) in 201 5

were used

. The estimated drinking water concentrations (EDWCs) of emamectin

benzoate were provided by the Environmental Fate and Effects Division (EFED). A

drinking water residue distribution based on the Pesticide Root Zone Model/Exposure

Analysis Modeling System ( PRZM/EXAMS ) modeling of the use on ornamentals was

used in the acute assessment.

The acute dietary exposure estimates for food and drinking water using the ornamentals

scenario for drinking water are below HED’s level of concern at the 99.9 th 

### percentile of

exposure for all population subgroups ( 6. 9 % of the aPAD for the general U.S. population

and 9.0 % of the aPAD for females 13

- 49 years old , the most highly exposed population

subgroup)

.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

A somewhat refined chronic dietary exposure assessment was conducted. The

anticipated residue estimates , used for most crops, were single point estimates (averages)

based on field trial data . Tolerance

- level residues were us ed for tree nuts (including

pistachios)

, cottonseed oil , and wine

. DEEM default processing factors were used except

for commodities with chemical

- specific processing studies. PCT data provided by BEAD

in 201 5 were used

. The EDWC of 0.150 μg/L (ppb) for the chronic exposure was based

on PRZM/EXAMS modeling of the u se on ornamentals

, which resulted in the highest

chronic EDWC considering all proposed/registered uses.Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

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### The chronic dietary exposure estimates for food and drinking water using the ornamentals

scenario for drinking water are below HED’s level of concern for all population

subgroups ( <1 % of the cPAD for the general U.S. population and <1 % of the cPAD for

all infants less than 1 year old and children 1

- 2 years old

, which are tied for the most

highly exposed population subgroup)

.

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Emamectin benzoate is classified as “not likely to be carcinogenic to humans” based on

the rodent carcinogenicity studies.

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 i n no unreasonable

adverse health effects). This dose is referred to as the population adjusted dose (PAD).

The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by

the required uncertainty or safety factors.

For acute and non

- can cer 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 are available on the EPA/pesticides web site: “Available

Information on Assessing Exposure from Pesticides, A User’s Guide,” 21

- JUN

- 2000,

web link : 

### http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2007

- 0780

-

0001 ; or see SOP 99.6 ( 20

- AUG

- 1999 ).

T he most recent dietary risk assessment for emamectin benzoate was conducted by

Nancy Dodd (15

- APR

- 2015, D426800). D426800 updated D402152 (N. Dodd, 20

- FEB

201 3 ) with revised toxicology endpoints for both the acute and chronic assessments ( i.e.,

aPAD = 0.0025 mg/kg bw/day; cPAD = 0.0025 mg/kg bw/day) . The current memo

D 430736 update s D426800 with percent crop treated data provided in 2015

. No new

crops have been added since D4 02152

.

II. Residue Information

Tolerances : Tolerances for plant commodities have been established under 40 CFR

§180.505(a)(1) for emamectin, including its metabolites and degradates. Compliance

with the tolerance levels specified is to be determined by measuring only the sum of

emamectin (a mixture of a minimum of 90% 4'

- epi

- methylamino

- 4'

- deoxyavermectin B 1a



### and maximum of 10% 4'

- epi

- methylamino

- 4'

- deoxyavermectin B 1b 

### ) and its metabolites

8,9

- isomer of the B 1a 

### and B 1b 

### component of the parent (8,9

- ZMA), or 4'

- deoxy

- 4'

- epi

amino

- avermectin B 1a 

### and 4'

- deoxy

- 4'

- epi

- amino

- avermectin B 1b 

### ; 4'

- deoxy

- 4'

- epi

- amino

avermectin B 1a 

### (AB 1a 

### ); 4'

- deoxy

- 4'

- epi

- ( N

- formyl

- N

- methyl)amino

- avermectin (MFB 1a 

### );

and 4'

- deoxy

- 4'

- epi

- ( N

- formyl)amino

- avermectin B 1a 

### (FAB 1a 

### ) , calculated as the

stoichiometric equivalent of emamectin, at levels ranging from 0.02 ppm to 0. 20 ppm.Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

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Page 4 of 29 

### Tolerances for livestock commodities have been established under 40 CFR

§180.505(a)(2) for emamectin, including its metabolites and degradates. Compliance

with the tolerance levels specified is to be determined by me asuring only the sum of

e mamectin (MAB 1a 

### + MAB 1b 

### isomers) and the associated 8,9

- Z isomers (8,9

- ZB 1a 

### + 8,9

-

ZB 1b 

### )

. The established tolerance levels are 0.010 ppm for the fat of cattle, goat, horse,

and sheep; 0.050 ppm for the liver of cattle, goat, horse, and sheep; 0.003 ppm for the

meat of cattle, goat, horse, and sheep; 0.020 ppm for the meat byproducts except liver of

cattle, goat, horse, and sheep; 0.003 ppm for hog fat; 0.020 ppm for hog liver; 0.002 ppm

for hog meat; 0.005 ppm for hog meat byproduct s except liver; and 0.003 ppm for milk.

No tolerances have been established for poultry commodities.

Residues of Concern: The residues of concern in plants for the tolerance expression and

dietary risk assessment are emamectin (MAB 1a 

### + MAB 1b 

### ), the associated 8,9

- Z isomers

(8,9

- ZB 1a 

### + 8,9

- ZB 1b 

### ), and metabolites/degradates AB 1a 

### , MFB 1a



### , and FAB 1a 

### . For

ruminant commodities, emamectin (MAB 1a 

### + MAB 1b 

### ) and its 8,9

- Z isomers (8,9

- ZB 1a 

### +

8,9

- ZB 1b 

### ) are included in the tolerance expression and dietary risk as sessment.

Residues in Crops :

Acute assessment: A probabilistic acute dietary exposure assessment was conducted.

The anticipated residue estimates, used for most crops, were based on field trial data.

Tolerance

- level residues were used for tree nuts (incl uding pistachios)

, cottonseed oil

, and wine . PDP monitoring data for years 2009 and 2010 were used for apples since

apple juice had a significant impact on exposure. DEEM default processing factors were

used except for commodities with chemical

- spec ific processing studies. PCT data

p rovided by the BEAD in 201 5 were used.

Chronic assessment: A somewhat refined chronic dietary exposure assessment was

conducted. The anticipated residue estimates, used for most crops, were single point

estimates (a verages) based on field trial data. Tolerance

- level residues were used for tree

nuts (including pistachios)

, cottonseed oil , and wine

. DEEM default processing factors

were used except for commodities with chemical

- specific processing studies. P CT data

p rovided by BEAD in 201 5 were used.

PDP monitoring data for apples were used in the acute assessment since apple juice has a

significant impact on exposure. Th e total number of apple samples from years 2009 and

2010 was 1278 with no detects at a limit o f detection (LOD) of 0.001 ppm.

For both acute and chronic assessments, field trial residue data were translated from

representative crops to other commodities in the crop group/subgroup according to the

following guidance document: “Guidance for Translation of Field Trial Data from

Representative Commodities in the Crop Group Regulation to Other Commodities in

Each Crop Group/Subgroup, HED Standard Operating Procedure 2000.1 (9/12/2000). ”Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

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### Processed Commodities : Processing studies are available o n apples (MRID 45899801),

tomatoes (MRID 46587002), cottonseed (MRID 44883716) , and wine (MRIDs 48758308

and 48758316) . The studies show that residues do not concentrate in apple juice, tomato

paste, tomato puree, cottonseed oil , and wine. A processing f actor of 1.0x is used for

apple juice, tomato paste, tomato puree, and cottonseed oil; the processing factor of 0.29x

is used for wine . The apple juice processing factor is translated to pear juice (1.0x).

DEEM default processing factors are applied to o ther processed co mmodities: apples,

dried (8.0x); pears, dried (6.25x); tomato juice (1.5x); tomato, dried (14.3x); and beef,

meat, dried (1.92x). (Note: Although a separate tolerance was established for tomato

paste in 40 CFR § 180.505, a subsequent toma to processing study indicated that residues

are not expected to concentrate in tomato paste; therefore, the processing factor of 1 .0 x is

used for tomato paste.)

Meat, Milk, Poultry, and Egg s : Residues in livestock commodities are b ased on the

livestock dietary burdens from Table 1 and the feeding study results from Table 2

.

Table 1 . Livestock Maximum Reasonable Dietary Burdens for Emamectin Benzoate

. 1

% Diet Dietary Contributions (ppm)

Feedstuff Type Tolerance,

ppm % Dry

Matter Beef Dairy Poultry Swine Beef Da ir y Poultry Swine

Almond hulls R 0. 0 55 3 90 NU 2 10 NU NU 0 0.0061 0 0

Cotton gin

byproducts R 0.050 90 5 NU NU NU 0.0028 0 0 0

Cotton hulls R 0.025 90 10 NU NU NU 0.0028 0 0 0

Untreated R 0

--- 0 35 0 0 0 0 0 0

Apple

pomace, wet CC 0.075 40 NU 2 10 NU NU 0 0.019 0 0

Untreated CC 0

-- 80 35 75 85 0 0 0 0

Cotton meal PC 0.025 89 5

-- 20 15 0.0014 0 0.0056 0.0042

Cotton,

undelinted

seed PC 0.025 88 NU 10 NU NU 0 0.0028 0 0

Untreated PC 0

--- 0 0 5 0 0 0 0 0

Totals 100 100 100 100 0.0070 0.02 8 0.0056 0.0042

1 All data are based on Table 1 Feedstuffs (June 2008). Residue levels for beef and d airy cattle are

corrected for moisture content and are determined by the following formula: tolerance ÷ % dry matter x %

in diet. Residue levels for poultry and swine are considered “as

- is” and are determined by the following

formula: tolerance x % in diet.

2 NU = Not Used.

3 Almond hulls are partially blended. The average residue value (0.055 ppm from MRI D 47243301) is

used for dairy cattle feed items. The HAFT of 0. 0985 ppm would be used for beef cattle, poultry

, or swine

.



### A n adequate cattle feeding study was submitted in conjunction with a previous petition

(PP#7F04845, D267346, M. Xue, 2/19/02 ). The maximum residues observed in cattle

matrices at each of the dosing levels are presented in T able 2 below. The reported LODs

and limits of quantitation ( LOQs ) for each analyte were 0.001 and 0.002 ppm,Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

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Page 6 of 29 

### respectively, in liver, kidney, muscle, and fat; 0 .0001 and 0.0005 ppm, respectively, in

milk (whole and skim); and 0.00025 and 0.0005 ppm, respectively, in cream.

Since all dietary burdens in Table 1 above are < 0.03 ppm, the residues from the low dose

(0.03 ppm ) cattle feeding study were used in the di etary assessments as the residue levels

in livestock commodities. Component r esidues used in the dietary assessment for whole

milk and cream are bolded in Table 2 below

. Component residues used for fat, kidney,

l iver, and meat (muscle) are also bolded. For residues reported as <LOD or <LOQ, 1⁄2 the

LOD or 1⁄2 the LOQ was used to sum the component residues . The total residues used in

the assessment were 0.003 ppm for fat, 0.0045 ppm for kidney, 0.01 ppm for liver, 0.002

ppm for meat, and 0.01 ppm for meat by products of cattle, goat, hog, horse, and sheep;

0.0003 ppm for milk, and 0.002 ppm for cream. No poultry commodity tolerances have

been established.

Table 2 . Maximum Residues Observed in Cattle M atrices in the Cattle Feeding Study

. 2

Matrix Low Dose (0.030 ppm) Mid Dose (0.090 ppm) High Dose (0.300 ppm)

MAB 1a +

8,9

- Z B 1a MAB 1b +

8,9

- Z B 1b MAB 1a +

8,9

- Z B 1a MAB 1b +

8,9

- Z B 1b MAB 1a +

8,9

- Z B 1a MAB 1b +

8,9

- Z B 1b

Whole milk <0.0005 <0.0001 0.0010 <0.0005 0.0053 0.0006 1

Skim milk <0.0005 <0.0001 0.0007 <0.0001 0.0030 <0.0005

Cream 0.0021 <0.0001 0.0046 <0.0005 0.021 0.0017 1

Fat 0.0022 <0.001 0.0066 <0.002 0.015 <0.002

Kidney 0.0040 <0.001 0.013 <0.001 0.042 0.0036 1

Liver 0.010 <0.001 0.029 0.0022 0.115 0.0090 1

Muscle <0.002 <0.001 0.0020 <0.001 0.0064 <0.001

1 This value represents the result for MAB 1b + 8,9

- Z B 1b in the sample containing the maximum residues of

MAB 1a + 8,9

- Z B 1a

.

2 Component residues used in the dietary assessment are bolded. For residues reported as <LOD or <LOQ,

1⁄2 the LOD or 1⁄2 the LOQ was used to sum the component residues.



### Catfish /Fish : The USDA Pesticide Data Program (PDP) monitored pesticide residues in

catf ish/fish in 2008, 2009, and 2010; however, the samples were not analyzed for

emamectin benzoate. As a result, residues in catfish/fish were not included in the

assessment.

Residue Data used for the Acute Dietary (Food + Drinking Water) Assessment:

A probabilistic acute dietary exposure assessment was conducted. The anticipated

residue estimates, used for most crops, were based on field trial data. Tolerance

- level

residues were used for tree nuts (incl uding pistachios)

, cottonseed oil , and wine

. PDP

monitoring data for years 2009 and 2010 were used for apples since apple juice had a

significant impact on exposure. DEEM default processing factors were used except for

commodities with available chemical

- specific processing studies. P CT data provided by

BEAD in 2015 were used. The EDWCs of emamectin benzoate were provided by EFED.Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

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Page 7 of 29 

### A drinking water residue distribution based on the PRZM/EXAMS modeling of the use

on ornamentals was used in the acute assessment.

R esidue Data used for the Chronic Dietary (Food + Drinking Water) Assessment:

A somewhat refined chronic dietary exposure assessment was conducted. The

anticipated residue estimates, used for most crops, were single point estimates (averages)

based on field trial data. Tolerance

- level r esidues were used for tree nuts (including

pistachios) , c ottonseed oil , and wine

. DEEM default processing factors were used except

for commodities with chemical

- specific processing studies. P CT data provided by BEAD

in 201 5 were used. The EDWC of 0.150 μg/L (ppb) for the chronic exposure was based

on PRZM/EXAMS modeling of the use on ornamentals, which resulted in the highest

chronic EDWC considering all proposed/registered uses.

III. Percent Crop Treated Information

A screening level usage analysis (S LUA) dated 7/15/15 was provided by BEAD based on

data years 200 4

- 2013

. (Refer to Attachment 2). The estimated maximum PCT f or each

of s eventeen crops was used for the acute dietary risk assessment and the estimated

weighted average PCT was used for the chronic dietary risk assessment

.

The following maximum PCT estimates (SLUA

, 7/15/15 ) were used in the acute dietary

risk assessment for the following crops that are currently registered for emamectin

benzoate: almonds: 10 %; apples: 20%; broccoli: 20%; Bru ssel s sprouts: 40%; cabbage:

25%; cauliflower: 20%; celery: 40%; cotton: 2.5%; cucumber: 2.5%; endive (grown from

chicory) : 10%; lettuce: 20%; pears: 20%; peppers: 15%; pistachios: 2.5%; spinach: 10%;

tomatoes: 20% ; and walnuts: 2.5%.

The following average PCT estimates (SLUA

, 7/15/15 ) were used in the chronic dietary

risk assessment for the following crops that are currently registered for emamectin

benzoate: almonds: 5 %; apples: 10%; broccoli: 5%; Brussel s sprouts: 20%; cabbage:

10%; cauliflower: 5 %; celery: 20 %; cotton: 1%; cucumber: 2.5%; endive ( grown from

chicory ): 2.5%; lettuce: 10%; pears: 5%; peppers: 5%; pistachios: 2.5%; spinach: 5%;

tomatoes: 10% ; and walnuts: 2.5%

.

For livestock commodities, the PCT for apples was used in the residue distribution files

(RDFs) for beef and dairy cattle; the PCT for cotton (the only poultry/swine feed item)

was used in the RDFs for swine.Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

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Page 8 of 29 

### IV. Drinking Water Data

T he drinking water residues used in the dietary risk assessment were provided by E FED

in the following memorandum : “ Amended Dri nking Water Assessment for the P ropose d

Use of Emamectin Benzoate on Outdoor Ornamentals and Group 9 Cucurbit V egetables”

( DP#402 307, Tiffany Dowen, 5/30/ 12 ) and incorporated directly into this dietary

assessment. Water residues were incorporated in the DEEM

- FCID into the food

categories “water, direct, all sources” and “water, indirect, all sources.”

EDWCs from use on outdoor

- grown ornamentals are the highest. Emamectin benzoate

residues (parent + degradation products), based on applications made to ornamentals and

group 9 cucurbits, are not expected to exceed 0.465 μg/L fo r the 1 in 10 year daily peak

, 0.150 μg/L for the 1 in 10 year annual average , and 0.112 μg/L for the 30 year annual

average (Table 3 ). A distribution of drinking water numbers using the ornamentals

scenario was used in the acute assessment. The EDWC of 0.150 μg/L was used in the

chronic assessment.

The Agency identified four degradates of concern based on structural similarity to

emamectin benzoate that are formed via photolysis (MARC memo references: D238206,

Sept 2, 1997; D255357, Aug 20, 2001; D277085, Aug 20, 2001):

• (8,9

- Z)

- 4"

- epimethylamino

- 4"

- deoxy avermectin B1 (8,9 ZMA isomer);

• 4"

- epiamino

- 4"

- deoxyavermectin B1 (AB);

• avermectin B1 monosaccharide (MAB); and

• 4"

- epi

- ( N

- formyl)

- 4"

- deoxyavermectin B1 (FAB)

.

These degradates were included in the drinking water assessment for emamectin benzoate

and are assumed to be of equal or lesser toxicity to that of the parent compound. The

total toxic residues approach is used for determining the e nvironmental fate data

parameters for modeling using the Guidance for Selecting Input Parameters in Modeling

the Environmental Fate and Transport of Pesticides , Version 2.1, October 22, 2009

, and

the draft Guidance for Modeling Pesticides Total Toxic Residues (TTR) , dated May 20

, 2009.

Table 3

. EDWCs for Emamectin Benzoate Residues from Use on Outdoor Ornamentals and

Group 9 Cucurbit Vegetables

. 1

Use Model 1 in 10 year 30 year Annual

Average Peak Annual Mean

μg/L

Surface Water

Ornamentals PRZM/EXAMS 2 0.465 0.150 0.112

Ground Water

Ornamentals/Group 9

Cucurbit Vegetables SCI

- GROW 0.54 x 10

- 3 0.54 x 10

- 3 0.54 x 10

- 3Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

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Page 9 of 29 1 Degradates of concern included in the calculation of EDWCs: (8,9

- Z)

- 4"

- epimethylamino

- 4"

- deoxy

a v ermectin B1, 4"

- ep iamino

- 4"

- deoxyavermectin B1, av ermectin B1 monosaccharide, and 4"

- epi

- ( N

formyl)

- 4"

- deoxyavermectin B1 (the 8,9 ZMA isomer, AB, MAB, and FAB, respectively).

2 Typically, the values generated by the models for drinking water are multiplied by a percent crop area

factor (PCA). The PCA accounts for the fact that is it unlikely for any basin to be completely planted to

agricultural crops. The PCA adjustment factor is assumed to be 0.87 for the group 9 cucurbit vegetables

and 1.0 for the outdoor ornamentals crops as per the PCA guidan ce.



### The model and its description are available at the EPA internet site:

http://www.epa.gov/oppefed1/models/water/

.

V. DEEM

- FCID Program and Consumption Information

Emamectin benzoate acute and chronic dietary exposure assessments were conducted

using DEEM

- FCID , V ersion 3.16, which incorporates 2003

- 2008 consumption data from

USDA’s NHANES/WWEIA. The data are based on the reported consumption of more

than 20,000 individuals over two no n

- consecutive survey days. Foods “as consumed”

(e.g., apple pie) are linked to EPA

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

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

- cooked; fresh or N/S, baked) using publicly

available recipe translation files developed jointly by USDA/ARS and EPA. For chronic

exposure assessment, consumption data are averaged for the entire U.S. population and

within population subgroups . However, for acute exposure assessment , consumption

data are retained as individu al consumption events. Based on analysis of the 2003

- 2008

WWEIA c onsumption data, which took into account dietary patterns and survey

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

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

- 2,

children 3

- 5, children 6

- 12, youth 13

- 19, adults 20

- 49, females 13

- 49, and adults 50

- 99

years old.

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

food

- fo rm (e.g., orange or orange juice) on the food commodity residue list is multiplied

by the average daily consumption estimate for that food/food form to produce a residue

intake estimate. The resulting residue intake estimate for each food/food form is sum med

with the residue intake estimates for all other food/food forms on the commodity residue

list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg

body weight/day and as a percent of the cPAD. This procedure is performed for each

population subgroup.

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 sum med 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 p ercentage of the aPAD on both a

user (i.e., only those who reported eating relevant commodities/food forms) and a per

capita (i.e., those who reported eating the relevant commodities as well as those who didEmamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

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Page 10 of 29 

### not) basis. In accordance with HED policy, per capita exposure and risk are reported for

analyses performed at all levels of refinement. However, for deterministic assessments,

any significant differences in user vs. per capita exposure and risk are specifically

identified and noted in the risk assess ment.

V I

. Toxicological Information

T he Agency has re

- evalua ted the entire emamectin toxicological database (D 426599 , N.

Dodd, 4/15/15 ). The toxicity endpoint and point of departure for all exposure scenarios

are now selected from the subchronic and chronic oral toxicity studies in dogs. A waiver

has been granted for the subchronic inhalation toxicity study (HASPOC Report: TXR No.

0051377, 3/12/15). No additional toxicology studies are required at this time.

The points of departure selected from th e dog studies are based on clear NOAELs and are

protective of all adverse effects seen in human

- relevant studies conducted in rats, CD

- 1

mice, and rabbits. Therefore, the FQPA safety factor has been reduced to 1x.

The doses and toxicological endpoints selected for use in dietary exposure assessments

are summarized in Table 4

.

Table 4 . Summary of Toxicological Doses and Endpoints for Emamectin benzoate for Use in Dietary

Exposure Assessments

. 1

Exposure/

Scenario P OD Uncertainty/

FQPA Safety

Factors RfD, PAD, Level

of Concern for

Risk Assessment Study and Toxicological

Effects

Acute Dietary

( All

Populations) NOAEL = 0.25

mg/kg/day UF A = 10x

UF H = 10x

FQPA SF =

1x Acute RfD =

0.0025

mg/kg/day Subchronic and chronic oral

toxicity st ud ies in dogs

Subchronic LOAEL = 0.5

mg/kg/day based skeletal

muscle atrophy and white

matter multifocal degeneration

in the brains of both sexes and

white matter multifocal

degeneration in the spinal

cords of males.

Chronic LOAEL=0.5

mg/kg/day based on axonal

degeneration in the pons,

medulla

, and peripheral nerves

(sciatic, sural, and tibial) ;

whole body tremors ; stiffness

of the hind legs, spinal cord

axonal degeneration, and

muscle fiber degeneration

. Chronic Dietary

(All

Populations) NOAEL = 0.25

mg/kg/day UF A = 10x

UF H = 10x

FQPA SF =

1x Chronic RfD =

0.0025

mg/kg/day Same as above.

Cancer (oral,

dermal,

inhalation) Classification: “Not likely to be Carcinogenic to Humans” based on the absence of

significant tumor incr eases in two adequate rodent carcinogenicity studies.Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 11 of 29 1 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

response data and used to mark the beginning of extrapolation to determine risk associated with lower

environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest

observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human

(interspecies). UF H = potential variation in sensitivi ty among members of the human population

(intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic).

RfD = reference dose.



### VI I

. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk

exceeds 100% of the PAD. The DEEM

- FCID analyses estimate the dietary exposure of

the U.S. population and various population subgroups. The results reported in Tables 5

and 6 are for the general U.S. Population, all infants (<1 year old), children 1

- 2, children

3

- 5, children 6

- 12, youth 13

- 19, females 13

- 49, adults 20

- 49, and adults 50

- 99 years.

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

The results of the acute dietary (food + drinking water) expos ure analysis at the 95 th 

### , 99 th



### , and 99.9 th 

### percentiles of exposure are reported in Table 5

. The emamectin benzoate acute

dietary risk estimates for food and drinking water using the ornamental scenario for

drinking water are below HED’s level of concern ( <100% aPAD) at the 99.9 th 

### percentile

of exposure for the general U.S. population and all population subgroups ( 6.9 % of the

aPAD for the general U.S. population and 9.0 % of the aPAD for femal es 13

- 49 years old,

the most highly exposed subgroup )

.

Table 5 . Results of Acute Dietary (Food and Drinking Water) Exposure Analysis Using DEEM FCID

. 1

Population Subgroup aPAD

(mg/kg/day) 95 th Percentile 99 th Percentile 99.9 th Percentile

Exposure

(mg/kg/day) %

aPAD Exposure

(mg/kg/day) %

aPAD Exposure

(mg/kg/day) %

aPAD

General U.S. Population 0.0025 0.000034 1.4 0.000085 3.4 0.000172 6.9

All Infants (< 1 year old) 0.000048 1.9 0.000084 3.4 0.000160 6.4

Children 1

- 2 years old 0.000048 1.9 0.000107 4.3 0.000187 7.5

Children 3

- 5 years old 0.000033 1.3 0.000076 3.0 0.000205 8.2

Children 6

- 12 years old 0.000022 0.88 0.000059 2.4 0.000101 4.0

Youth 13

- 19 years old 0.000014 0.56 0.000036 1.4 0.000132 5.3

Adults 20

- 49 years old 0.000034 1.4 0.000095 3.8 0.000186 7.5

Adults 50

- 99 years old 0.000040 1.6 0.000088 3.5 0.000176 7.0

Females 13

- 49 years old 0.000034 1.4 0.000097 3.9 0.000226 9.0

1 The population with the highest exposure is bolded.Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 12 of 29 

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

The results of the chronic dietary (food and drinking water) exposure analysis are

reported in the summary table below. For the chronic dietary assessment, all population

subgroups have risk estimates which are below HED’s level of concern. The emamectin

benzoate chronic dietary risk estimates for food and drinking water using the ornamental

scenario for drinking water are below HED’s level of concern for the general U.S.

population and all population subgroups ( <1% of the cPAD for the general U.S.

popula tion and <1% of the cPAD for all infants less than 1 year old and children 1

- 2

years old, which are tied for the most highly exposed subgroup )

.

Table 6 . Summary of Dietary (Food and Drinking Water) Exposure and Risk for Emamectin

Benzoate

.

Population Subgroup Acute Dietary

(99.9 Percentile) Chronic Dietary

Dietary Exposure

(mg/kg/day) % aPAD* Dietary

Exposure

(mg/kg/day) % cPAD*

General U.S. Population 0.000172 6.9 0.000008 <1

All Infants (<1 year old)* 0.000160 6.4 0.000014 <1

Children 1

- 2 years old* 0.000187 7.5 0.000014 <1

Children 3

- 5 years old 0.000205 8.2 0.000010 <1

Children 6

- 12 years old 0.000101 4.0 0.000007 <1

Youth 13

- 19 years old 0.000132 5.3 0.000005 <1

Adults 20

- 49 years old 0.000186 7.5 0.000008 <1

Adults 50

- 99 years old 0.000176 7.0 0.000009 <1

Females 13

- 49 years old * 0.000226 9.0 0.000008 <1

*The subpopulations with the highest risk estimates are bolded.



### VII I

. Characterization of Inputs/Outputs

The acute and chronic assessment s for f ood incorporate somewhat refined anticipated

residue estimates for most commodities that were derived from field trial data and P CT

data. Monitoring data were used for apples in the acute assessment since apple juice had

a significant impact on exposure. The use of more monitoring data and food preparation

reduction factors for washing, cooking, etc. may have re sulted in more refined estimate s

of dietary exposure. M ore highly refined analys e s are not needed at this time since the

risk estimates are below HED’s level of concern.Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 13 of 29 

### I X

. Conclusions

The acute dietary exposure assessment is a probabilistic assessment conducted for all

proposed/registered food uses of emamectin benzoate and drinking water. The

anticipated residue estimates used for most crops were based on field trial dat a,

incorporated PCT estimates provided by BEAD , and processing factors where

appropriate. PDP monitoring data were used for apples. A drinking water residue

distribution based on the use on ornamentals was used in the acute assessment. The acute

dietary exposure estimates for food and drinking water are below HED’s level of concern

at the 99.9 th 

### percentile of exposure for all population subgroups ( 6.9 % of the aPAD for

the general U.S. population and 9.0 % of the aPAD for females 13

- 49 years old).

The chronic dietary exposure assessment is a somewhat refined assessment conducted for

all proposed/registered food uses of emamectin benzoate and drinking water

. The

anticipated residue estimates used for most crops were single point estimates (averages)

based on field trial data, incorporated PCT estimates provided by BEAD, and processing

factors where appropriate. An EDWC based on the use on ornamentals was used in the

chronic assessment. The chronic dietary exposure estimates for food and drinking wat er

are below HED’s level of concern for all population subgroups ( <1 % of the cPAD for the

general U.S. population and <1 % of the cPAD for all infants less than 1 year old and

children 1

- 2 years old )

.

X. List of Attachments

Attachment 1 : Acute Residue Distribution Files and Chronic Point Estimates

. Attachment 2 : Percent Crop Treated Memo s from BEAD.

Attachment 3 : Acute Food plus Water Residue Input File.

Attachment 4 : Acute Results File.

Attachment 5 : Chronic Food plus Water Residue Input File.

Attach m ent 6 : Chronic Results File.Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 14 of 29 

### Attachment 1: Acute Residue Distribution Files and Chronic Point Estimates

R DF 1

'Apple , PDP Data, 20%CT

TOTALZ= 1022

TOTAL LOD=256

LODRES=0.0005 RDF 2

'Bell Pepper

Field trial data 15 %CT

TOTALZ=17

TOTALNZ=3

0.010

0.010

0.010 RDF 3

'Broccoli

Field trial data 2 0 %CT

TOTALZ=48

TOTALNZ=12

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.004

0.004

0.0064

0.0045 RDF 4

'Cabbage

Field trial data 2 5%CT

TOTALZ=54

TOTALNZ=18

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.004

0.004

Chronic Apple Field Trial

data; n = 30 Chronic= 0.010 x 0.05

= 0.0005 Chronic= 0.003 x 0.05=

0.00015 Chronic= 0.002 x 0.10=

0.0002

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556 0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.009055

0.007055

Chronic= 0.0020 x 0.10=

0.00020Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 15 of 29 RDF 5

‘Cauliflower

Field trial data 2 0%CT

TOTALZ=48

TOTALNZ=12

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.004 RDF 6

'Celery

Field trial data 40 %CT

TOTAL Z=32

TOTALNZ=21

0.008

0.008

0.006

0.006

0.006

0.006

0.004

0.004

0.002

0.0082

0.0069

0.0121

0.0104

0.0055

0.0062

0.0066

0.0048

0.0054

0.0083

0.0075

0.0044 RDF 7

'Lettuce

- head

Field trial data 20%CT

TOTALZ=68

TOTALNZ=17

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.002

0.006

0.006

0.006

0.0065

0.004

0.0067

0.0063 RDF 8

'Lettuce

- leaf

Field trial data 20%CT

TOTALZ=80

TOTALNZ=20

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.012

0.012

0.014

0.014

0.0114

0.028

0.025

0.033

0.047

0.011

0.016

0.017

0.039

Chronic= 0.002 x 0. 05 =

0.0001 Chronic= 0.006 5 x

0.20 = 0.00 13 Chronic= 0.0036 x

0.10= 0.0004 Chronic= 0.017 x 0.10=

0.0 017Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 16 of 29 RDF 9

'Mustard greens

Field trial data 100 %CT

TOTALZ=0

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.013

0.013

0.013

0.013

0.014

0.016

0.1212 RDF 10

'Non

- bell peppers

Field trial data 15 %CT

TOTALZ=6 8

TOTALNZ=12

0.010

0.010

0.010

0.010

0.010

0.010

0.010

0.010

0.010

0.010

0.010

0.010 RDF 11

'Pear

Field trial data 2 0%CT

TOTALZ=64

TOTALNZ=16

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.008055

0.007055

0.007055

0.007055 RDF 12

'Spinach

Field trial data 10 %CT

TOTALZ=54

TOTALNZ=6

0.01 0

0.01 0

0.011

0.011

0.011

0.012

Chronic= 0.017 x 1= 0.0 2 Chronic= 0.010 x

0. 05 = 0.00 05 Chronic= 0.00 30 x

0.05= 0.00015 Chronic= 0.011 x 0.0 5 =

0.00 055Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 17 of 29 RDF 13

‘Tomato Field trial data

2 0 %CT

TOTALZ=12 4

TOTALNZ=31

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.001556

0.003556

0.003556

0.003556

0.003556

0.003556

0.003556

0.005

0.005 RDF 14

‘Milk [a pple 20 %CT]

TOTALZ=80

20 ,0.00 03 RDF 15

'Cattle fat [ apple

20 %CT]

TOTALZ=80

20 ,0.003 RDF 16

'Cattle liver [ apple

20 %CT]

TOTALZ=80

20 ,0.01

Chronic= 0.0022 x 0.10=

0.0002 Chronic= 0.00 0 3 x

0.1 0 = 0.00 0 0 3 Chronic= 0.003 x 0. 10 =

0.00 0 3 Chronic= 0.01 x 0. 10 =

0.00 1Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 18 of 29 RDF 17

'Cattle meat [ apple

20 %CT]

TOTALZ=80

20 ,0.002 RDF 18

'Cattle meat byproduct

[ apple 20 %CT]

TOTALZ=80

20 ,0.0 1 RDF 19

'Hog fat [ cotton

2.5 %CT]

TOTALZ=97

3 ,0.003 RDF 20

'Hog liver [ cotton

2 .5 %CT]

TOTALZ=97

3, 0.01

Chronic= 0.002 x 0. 10 =

0.000 2 Chronic= 0.01 x 0. 10 =

0.00 1 Chronic = 0.003 x 0. 01

= 0.000 03 Ch ronic = 0.01 x 0. 01 =

0.00 01

RDF 21

'Hog meat [ cotton

2 .5 %CT]

TOTALZ=97

3, 0.002 RDF 22

‘Hog meat bypd [ cotton

2 .5 %CT]

TOTALZ=97

3 ,0.01 RDF 23

'Cream

[a pple 20 %CT]

TOTALZ=80

20 ,0.00 2 RDF 24

‘ Cantaloupe

Field trial data

100 %CT

TOTALZ= 0

0.0030

0.0030

0.0030

0.0030

0.0036

0.0040

0.0037

0.0032

0.0051

0.0037

Chronic = 0.002 x 0. 01

= 0.00002 Chronic = 0.01 x 0. 01 =

0.00 01 Chronic = 0.00 2 x 0.10

= 0.0 0 0 2 Chronic = 0.0035 x 0.40

= 0.00 1 4

RDF 25

‘Cucumber

Field trial data 2.5 %CT

TOTALZ= 312

TOTALNZ=8

0.004

0.004

0.004

0.004

0.004

0.004

0.004

0.004 RDF 26

‘Summer Squash

Field trial data 100 %CT

TOTALZ=0

0.0061

0.0061

0.0061

0.0061

0.0061

0.0061

0.0061

0.0061 RDF 27

‘ Winter Squash Field

Trial data 100% CT

TOTALZ=0

0.0061

0.0061

0.0061

0.0061

0.0061

0.0061

0.0061

0.0 061 RDF 28

‘ Watermelon

Cantaloupe field t rial

data 100 %CT

TOTALZ=0

0.0030

0.0030

0.0030

0.0030

0.003 6

0.00 40

0.003 7

0.0032

0.0051

0.003 7

Chronic = 0.004 x

0. 025 = 0.00 01 Chronic = 0.0061 x

0.29

= 0.00 18 Chronic = 0.0061 x

0.29 = 0.00 18 Chronic = 0.0035 x 0.19

= 0.0006 6Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 19 of 29 RDF 29

Almond

10 %CT

TOTALZ=9 4 54

6, 0.006 RDF 30

'Cattle kidney [ apple

20 %CT]

TOTALZ=80

20 , 0.0045 RDF 31

'Subgroup 9A Other

Cantaloupe Field Trial

data 100%CT

TOTALZ=0

0.0030

0.0030

0.0030

0.0030

0.0036

0.0040

0.0037

0.0032

0.0051

0.003 7 RDF 32

Ormamentals Drinking

Water

Chronic = 0.006 x 0.0 5

= 0.00 03 Chronic = 0.0045 x

0.10 = 0.00045 Chronic = 0.0035 x 1 =

0.003 5 Chronic = 0.000150

RDF 33

Hog kidney [cotton

2.5%CT]

TOTALZ=97

3, 0.0045 RDF 34

‘ Brussels sprouts

40%CT

TOTALZ=6

TOTALNZ=4

0.004

0.004

0.004

0.004 RDF 35

Endive

Spinach FT 10%CT

TOTALZ=27

TOTALNZ=3

0.030

0.032

0.050 RDF 36

Pistachio

Almond FT 2.5%CT

TOTALZ=234

TOTALNZ=6

0.006

0.006

0.006

0.006

0.006

0.006

Chronic = 0.0045 x

0.01 = 0.000045 Chronic=0.004 x

0.20=0.0008 Chronic0.037 x

0.025=0.00092 Chronic = 0.006 x 0.025

=0.00015

RDF 37

Walnut

Pecan FT 2.5%CT

TOTALZ=234

TOTALNZ=6

0.006

0.006

0.006

0.006

0.006

0.006

Chronic = 0.006 x

0.025 = 0.00015Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 20 of 29 

### Attachment 2 : Percent Crop Treated Memo s from BEAD

A screening level usage analysis (SLUA) dated 7/15/15 was provided by BEAD based on

data years 200 4

- 20 13

. The following data were excerpted from the 7/15/15 SLUA.

Screening Level Estimates of Agricultural Uses of Emamectin B enzoate ( 7/15/15 )

Crop Percent Crop Treated

Average Maximum

Almonds 5 10

Apples 10 20

Broccoli 5 20

Brussels sprouts 20 40

Cabbage 10 25

Cauliflower 5 20

Celery 20 40

Cotton <1 <2.5

Cucumbers <2.5 <2.5

Endive* <2.5 10

Lettuce 10 20

Pears 5 20

Peppers 5 15

Pistachios <2.5 <2.5

Spinach 5 10

Tomatoes 10 20

Walnuts <2.5 <2.5

* Chicory %CT was reported. Endive (Crop Group 4) can be grown from chicory.Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 21 of 29 

### Attachment 3 : Acute Food plus Water Residue Input File

Filename: C: \ Documents and Settings \ NDODD \ My Documents \ DEEM Version 3.16 \ Emamectin

benzoate 121515 \ EMAMECTINACUTEWine121515.R08

Chemical: Emamectin Benzoate

RfD(Chronic): .0025 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .0025 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last m odified: 12

- 15

- 2015/13:01:17 Program ver. 3.16, 03

- 08

- d

----------------------------------------------------------------------------------- RDL indices and parameters for Monte Carlo Analysis:

Index Dist Parameter #1 Param #2 Param #3 Commen t

# Code

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

1 6 apple.rdf

2 6 bellpepper.rdf

3 6 broccoli.rdf

4 6 cabbage.rdf

5 6 cauliflower.rdf

6 6 celery.rdf

7 6 lettucehead.rdf

8 6 lettuceleaf.rdf

9 6 mustardgreen.rdf

10 6 nonbellpepper.rdf

11 6 pear.rdf

12 6 spinach.rdf

13 6 tomato.rdf

14 6 milk.rdf

15 6 cattlefat.rdf

16 6 cattleliver.rdf

17 6 cattlemeat.rdf

18 6 cattlembypd.rdf

19 6 hogfat.rdf

20 6 hogliver.rdf

21 6 hogmeat.rdf

22 6 hogmeatbypd.rdf

23 6 cream.RDF

24 6 cantaloupe.rdf

25 6 cucumber.rdf

26 6 Summer squash.rdf

27 6 Winter squash.rdf

28 6 watermelon.rdf

29 6 almond.rdf

30 6 cattlekidney.rdf

31 6 Subgroup 9A Other.rdf

32 6 ornamentals DW.rdf

33 6 hog kidney.rdf

34 6 Brussels sprouts.rdf

35 6 Endive.rdf

36 6 Pistachio.rdf

37 6 W alnut.rdf

EPA Crop Commodity Name Def Res Adj.Factors RDLComment

Code Grp (ppm) #1 #2 Pntr

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 0401005000 4A Amaranth, leafy 0.012000 1.000 1.000

0401018000 4A Arugula 0.012000 1.000 1.000

0401104000 4A Chrysanthemum, garland 0.012000 1.000 1.000

0401 133000 4A Cress, garden 0.012000 1.000 1.000

0401134000 4A Cress, upland 0.012000 1.000 1.000

0401138000 4A Dandelion, leaves 0.012000 1.000 1.000

0401150000 4A E ndive 0.012000 1.000 1.000 35 D32814

Full comment: D328149, MRID 46587001

0401204000 4A Lettuce, head 0.006700 1.000 1.000 7

0401205000 4A Lettuce, leaf 0.047000 1. 000 1.000 8

0401248000 4A Parsley, leaves 0.012000 1.000 1.000

0401313000 4A Radicchio 0.006700 1.000 1.000

0401355000 4A Spinach 0.012000 1.000 1.000 1 2

0401355001 4A Spinach

- babyfood 0.012000 1.000 1.000 12

0402076000 4B Cardoon 0.012100 1.000 1.000Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 22 of 29 0402085000 4B Celery 0.012100 1.000 1.000 6

0402085001 4B Celery

- babyfood 0.012100 1.000 1.000 6

0402086000 4B Celery, juice 0.012100 1.000 1.000 6

0402087000 4B Celtuce 0.012100 1.000 1.000

0402152000 4B Fennel, Florence 0.012100 1.000 1.000

0402322000 4B Rhubarb 0.012100 1.000 1.000

0402367000 4B Swiss chard 0.012100 1.000 1.000

0501061000 5A Broccoli 0.006400 1.000 1.000 3

0501061001 5A Broccoli

- babyfood 0.006400 1.000 1.000 3

0501062000 5A Broccoli, Chinese 0.006400 1.000 1.000

0501064000 5A Brussels sprouts 0.004000 1.000 1.000 34 D39251

Full comment: D392510, MRID 48539701

0501069000 5A Cabbage 0.004000 1.000 1.000 4

0501071000 5A Cabbage, Chinese, napa 0.004000 1.000 1.000

05010 72000 5A Cabbage, Chinese, mustard 0.006400 1.000 1.000

0501083000 5A Cauliflower 0.004000 1.000 1.000 5

0501196000 5A Kohlrabi 0.004000 1.000 1.000

0502063000 5B Br occoli raab 0.121200 1.000 1.000 9

0502070000 5B Cabbage, Chinese, bok choy 0.121200 1.000 1.000 9

0502117000 5B Collards 0.121200 1.000 1.000 9

0502194000 5B Kale 0.121200 1.000 1.000 9

0502229000 5B Mustard greens 0.121200 1.000 1.000 9

0502318000 5B Rape greens 0.121200 1.000 1.000 9

0502389000 5B Turnip, greens 0.121200 1.000 1.000 9

0801374000 8A Tomatillo 0.005000 1.000 1.000

0801375000 8A Tomato 0.005000 1.000 1.000 13

0801375001 8A Tomato

- babyfood 0.0050 00 1.000 1.000 13

0801376000 8A Tomato, paste 0.002200 1.000 0.200 B; no

Full comment: B; no concentration (D328149)

0801376001 8A Tomato, paste

- babyfood 0.002200 1.000 0.200 B

0801377000 8A Tomato, puree 0.002200 1.000 0.200 B; no

Full comment: B; no concentration (D328149)

0801377001 8A Tomato, puree

- babyfood 0.002200 1.000 0.200 B

0801378000 8A Tomato, dried 0.002200 14.300 0.200 B

0801378001 8A Tomato, dried

- babyfood 0.002200 14.300 0.200 B

0801379000 8A Tomato, juice 0.005000 1.500 1.000 13

0801380000 8A Tomato, Tree 0.005000 1.000 1.000

0802148000 8BC Eggplant 0.010000 1.000 1.000

0802234000 8BC Okra 0.010000 1.000 1.000

0802270000 8B Pepper, bell 0.010000 1 .000 1.000 2

0802270001 8B Pepper, bell

- babyfood 0.010000 1.000 1.000 2

0802271000 8B Pepper, bell, dried 0.010000 1.000 0.150 Blende

Full comment: Blended (B)

0802271001 8B Pepper, bell, dried

- baby food 0.010000 1.000 0.150 B

0802272000 8BC Pepper, nonbell 0.010000 1.000 1.000 10

0802272001 8BC Pepper, nonbell

- babyfood 0.010000 1.000 1.000 10

0802273000 8BC Pepper, nonbell, dried 0 .010000 1.000 0.150 B

0901075000 9A Cantaloupe 0.005100 1.000 1.000 24 LOQ =

Full comment: LOQ = 0.001 x 6; used 1/2 LOQ for ND

0901187000 9A Honeydew melon 0.005100 1.000 1.000 31

090 1399000 9A Watermelon 0.005100 1.000 1.000 28

0901400000 9A Watermelon, juice 0.005100 1.000 1.000 28

0902021000 9B Balsam pear 0.004000 1.000 1.000

0902088000 9B Chayote, fruit 0.006100 1.000 1.000

0902102000 9B Chinese waxgourd 0.004000 1.000 1.000

0902135000 9B Cucumber 0.004000 1.000 1.000 25 LOD =

Full comment: LOD = 0.004

0902308000 9B Pumpkin 0.006100 1.000 1.000

0902309000 9B Pumpkin, seed 0.006100 1.000 1.000 B

0902356000 9B Squash, summer 0.006100 1.000 1.000 26 LOD =

Full comment: LOD = 0.0061

0902356001 9B Squash, summer

- babyfood 0.006100 1.000 1.000 26

0902357000 9B Squash, winter 0.006100 1.000 1.000 27

0902357001 9B Squash, winter

- babyfood 0.006100 1.000 1.000 27

1100007000 11 Apple, fruit with peel 0.009055 1.000 1.000 1

1100008000 11 Apple, peeled fruit 0.009055 1.000 1.000 1

1100008001 11 Apple, peeled fruit

- babyfood 0.009055 1.000 1.000 1

1100009000 11 Apple, dried 0.002000 8.000 0.200 B

1100009001 11 Apple, dried

- babyfood 0.002000 8.000 0.200 B

1100010000 11 Apple, juice 0.009055 1.000 1.000 1Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 23 of 29 11000 10001 11 Apple, juice

- babyfood 0.009055 1.000 1.000 1

1100011000 11 Apple, sauce 0.009055 1.000 1.000 1

1100011001 11 Apple, sauce

- babyfood 0.009055 1.000 1.000 1

1100129000 11 Cr abapple 0.009055 1.000 1.000

1100173500 11 Goji berry 0.005000 1.000 1.000

1100210000 11 Loquat 0.008055 1.000 1.000

1100266000 11 Pear 0.008055 1.000 1.000 11

1100266001 11 Pear

- babyfood 0.008055 1.000 1.000 11

1100267000 11 Pear, dried 0.003000 6.250 0.200 B

1100268000 11 Pear, juice 0.008055 1.000 1.000 11

1100268001 11 Pear, juice

- babyfood 0.008055 1.000 1.000 11

1100310000 11 Quince 0.008055 1.000 1.000

1304179000 13D Grape, wine and sherry 0.050 000 0.290 1.000 MRID 4

Full comment: MRID 48758308

1400003000 14 Almond 0.020000 1.000 1.000 29

1400003001 14 Almond

- babyfood 0.020000 1.000 1.000 29

1400004000 14 Almond, oil 0.020000 1.000 0.100 B

1400004001 14 Almond, oil

- babyfood 0.020000 1.000 0.100 B

1400059000 14 Brazil nut 0.020000 1.000 1.000

1400068000 14 Butternut 0.020000 1.000 1.000

1400081000 14 Cashew 0.020000 1.000 1.000

1400092000 14 Chestnut 0.020000 1.000 1.000

1400155000 14 Hazelnut 0.020000 1.000 1.000

1400156000 14 Hazelnut, oil 0.020000 1.000 1.000 B

1400185000 14 Hickory nut 0.020000 1.000 1.000

1400213000 14 Macadamia nut 0.020000 1.000 1.000

1400269000 14 Pecan 0.020000 1.000 1.000

1400278000 14 Pine nut 0.020000 1.000 1.000

1400282000 14 Pistachio 0.020000 1.000 1.000 36 D32814

Full comment: D328149, MRID 47243301

1400391000 14 Walnut 0.020000 1.000 1.000 37 D32814

Full comment: D328149, MRID 47243301

2003128000 20C Cottonseed, oil 0.025000 1.000 0.025 B

2003128001 20C Cottonseed, oil

- babyfood 0.025000 1.000 0.025 B

3100044000 31 Beef, meat 0.002000 1.000 1.000 17

3100044001 31 Beef, meat

- babyfood 0.002000 1.000 1.000 17

3100045000 31 Beef, meat, dried 0.002000 1.920 1.000 17

3100046000 31 Beef, meat byproducts 0.010000 1.000 1.000 18

3100046001 31 Beef, meat byproducts

- babyfood 0.010000 1.000 1.000 18

3100047000 31 Beef, fat 0.003000 1.000 1.000 15

3100047001 31 Beef, fat

- babyfood 0.003000 1.000 1.000 15

3100048000 31 Beef, kidney 0.004500 1.000 1.000 30

3100049000 31 Beef, liver 0.010000 1.000 1.000 16

3100049001 31 Beef, liver

- babyfood 0.010000 1.000 1.000 16

3200169000 32 Goat, meat 0.002000 1.000 1.000 17

320017 0000 32 Goat, meat byproducts 0.010000 1.000 1.000 18

3200171000 32 Goat, fat 0.003000 1.000 1.000 15

3200172000 32 Goat, kidney 0.004500 1.000 1.000 30

3200173000 32 Goat, liver 0.010000 1.000 1.000 16

3300189000 33 Horse, meat 0.002000 1.000 1.000 17

3400290000 34 Pork, meat 0.002000 1.000 1.000 21

3400290001 34 Pork, meat

- babyfood 0.002000 1.000 1.000 21

3400291000 34 Pork, skin 0.010000 1.000 1.000 22

3400292000 34 Pork, meat byproducts 0.010000 1.000 1.000 22

3400292001 34 Pork, meat byproducts

- babyfood 0.010000 1.000 1.000 22

3400293000 34 Pork, fat 0.003000 1.000 1.000 19

3400293001 34 Pork, fat

- babyfood 0.003000 1.000 1.000 19

3400294000 34 Pork, kidney 0.004500 1.000 1.000 33

3400295000 34 Pork, liver 0.010000 1.000 1.000 20

3500339000 35 Sheep, meat 0.002000 1.000 1.000 17

3500339001 35 Sheep, meat

- babyfood 0 .002000 1.000 1.000 17

3500340000 35 Sheep, meat byproducts 0.010000 1.000 1.000 18

3500341000 35 Sheep, fat 0.003000 1.000 1.000 15

3500341001 35 Sheep, fat

- babyfood 0.003000 1.0 00 1.000 15

3500342000 35 Sheep, kidney 0.004500 1.000 1.000 30

3500343000 35 Sheep, liver 0.010000 1.000 1.000 16

3600222000 36 Milk, fat 0.002000 1.000 1.000 23

3600222001 36 Milk, fat

- baby food/infant formu 0.002000 1.000 1.000 23

3600223000 36 Milk, nonfat solids 0.000300 1.000 1.000 14

3600223001 36 Milk, nonfat solids

- baby food/in 0.000300 1.000 1.000 14Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 24 of 29 3600224000 36 Milk, water 0.000300 1.000 1.000 14

3600224001 36 Milk, water

- babyfood/infant form 0.000300 1.000 1.000 14

3600225001 36 Milk, sugar (lactose)

- baby food/ 0.000300 1.000 1.000 14

8601000000 86A Water, direct, all sources 0.000465 1.000 1.000 32

8602000000 86B Water, indirect, all sources 0.000465 1.000 1.000 32Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 25 of 29 

### Attachment 4: A c ute Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for EMAMECTIN BENZOATE NHANES 2003

- 2008 2

- Day

Residue file: EMAMECTINACUTEWine121515.R08 Adjustment factor #2 used.

Analysis Date: 12

- 15

- 2015/15:46:20 Residue file dated: 12

- 15

- 2015/13:01:17

RAC/FF intake sum med over 24 hours

MC iterations = 1000; MC list in residue file; MC seed = 10; RNG = MS VB

Run Comment: ""

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

Summary calculations

-- per capita:

95th Percentil e 99th Percentile 99.9th Percentile

Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population:

0.000034 1.35 0.000085 3.39 0.000172 6.89

All Infants:

0.000048 1.90 0.000084 3.36 0.000160 6.41

Children 1

- 2:

0.000048 1.92 0.000107 4.28 0.000187 7.49

Children 3

- 5:

0.000033 1.32 0.000076 3.05 0.000205 8.22

Children 6

- 12:

0.000022 0.88 0.000059 2.37 0.000101 4.04

Youth 13

- 19:

0.000014 0.56 0.000036 1.43 0.000132 5.29

Adults 20

- 49:

0.000034 1.35 0.000095 3.81 0.000186 7.46

Adults 50

- 99:

0.000040 1.60 0.000088 3.50 0.00 0176 7.02

Female 13

- 49:

0.000034 1.37 0.000097 3.87 0.000226 9.04

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for EMAMECTIN BENZOATE NHANES 2 003

- 2008 2

- Day

Residue file: EMAMECTINACUTEWine121515.R08 Adjustment factor #2 used.

Analysis Date: 12

- 15

- 2015/15:46:20 Residue file dated: 12

- 15

- 2015/13:01:17

RAC/FF intake summed over 24 hours

MC iterations = 1000; MC list in residue file; MC seed = 10; RNG = MS VB

Run Comment: ""

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

Summary calculations

-- users:

95th Percentile 99th Percentile 99.9th Percentile

Exposu re % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population:

0.000034 1.35 0.000085 3.39 0.000172 6.89

All Infants:

0.000050 2.01 0.000087 3.46 0.000164 6.56

Children 1

- 2:

0.000048 1.92 0.000107 4.28 0.000187 7.50

Children 3

- 5:

0.000033 1.32 0.000076 3.05 0.000205 8.22

Children 6

- 12:

0.000022 0.88 0.000059 2.37 0.000101 4.05

Youth 13

- 19:

0.000014 0.56 0.000036 1.43 0.00 0132 5.29

Adults 20

- 49:

0.000034 1.35 0.000095 3.81 0.000186 7.46

Adults 50

- 99:

0.000040 1.60 0.000088 3.50 0.000176 7.02

Female 13

- 49:

0.000034 1.37 0.000097 3.87 0.000226 9.05Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 26 of 29 

### Attachment 5: Chronic Residue Input File

Filename: C: \ Documents and Settings \ NDODD \ My Documents \ DEEM Version 3.16 \ Emamectin

benzoate 121515 \ EMAMECTINCHRONICWine121515.R08

Chemical: Emamectin Benzoate

RfD(Chroni c): .0025 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .0025 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 12

- 16

- 2015/10:10:12 Program ver. 3.16, 03

- 08

- d

------------------------------------------------------------ ----------------------- EPA Crop Def Res Adj.Factors Comment

Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ----- - ------- 0401005000 4A Amaranth, leafy 0.011000 1.000 1.000

0401018000 4A Arugula 0.011000 1.000 1.000

0401104000 4A Chrysanthemum, garland 0.011000 1.000 1.000

0401133000 4A Cress, garden 0.011000 1.000 1.000

0401134000 4A Cress, upland 0.011000 1.000 1.000

0401138000 4A Dandelion, leaves 0.011000 1.000 1.000

0401150000 4A Endive 0.011000 1.000 0.025

0401204000 4A Lettuce, head 0.003600 1.000 0.100

0401205000 4A Lettuce, leaf 0.017000 1.000 0.100

0401248000 4A Parsley, leaves 0.011000 1.000 1.000

0401313000 4A Radicchio 0.003600 1.000 1.000

0401355000 4A Spinach 0.011000 1.000 0.050

0401355001 4A Spinach

- babyfood 0.011000 1.000 0.050

0402076000 4B Cardoon 0.006500 1.000 1.000

0402085000 4B Celery 0.006500 1.000 0.200

0402085001 4B Celery

- babyfood 0.006500 1.000 0.200

0402086000 4B Celery, juice 0.006500 1.000 0.200

0402087000 4B Celtuce 0.006500 1.000 1.000

0402152000 4B Fennel, Florence 0.006500 1.000 1.000

0402322000 4B Rhubarb 0.006500 1.000 1.000

0402367000 4B Swiss chard 0.006500 1.000 1.000

0501061000 5A Broccoli 0.003000 1.000 0.050

0501061001 5A Broccoli

- babyfood 0.003000 1.000 0.05 0

0501062000 5A Broccoli, Chinese 0.003000 1.000 1.000

0501064000 5A Brussels sprouts 0.002000 1.000 0.200

0501069000 5A Cabbage 0.002000 1.000 0.100

0501071000 5A Cabba ge, Chinese, napa 0.002000 1.000 1.000

0501072000 5A Cabbage, Chinese, mustard 0.003000 1.000 1.000

0501083000 5A Cauliflower 0.002000 1.000 0.050

0501196000 5A Kohlrabi 0.002000 1.000 1.000

0502063000 5B Broccoli raab 0.017000 1.000 1.000

0502070000 5B Cabbage, Chinese, bok choy 0.017000 1.000 1.000

0502117000 5B Collards 0.017000 1.000 1.000

0502194000 5B Kale 0.017000 1.000 1.000

0502229000 5B Mustard greens 0.017000 1.000 1.000

0502318000 5B Rape gree ns 0.017000 1.000 1.000

0502389000 5B Turnip, greens 0.017000 1.000 1.000

0801374000 8A Tomatillo 0.002200 1.000 1.000

0801375000 8A Tomato 0.002200 1.000 0.100

0801375001 8A Tomato

- babyfood 0.002200 1.000 0.100

0801376000 8A Tomato, paste 0.002200 1.000 0.100

0801376001 8A Tomato, paste

- babyfood 0.002200 1.000 0.100

0801377000 8A Tomato, puree 0.002200 1.000 0.100

0801377001 8A Tomato, puree

- babyfood 0.002200 1.000 0.100

0801378000 8A Tomato, dried 0.002200 14.300 0.100

0801378001 8A Tomato, dried

- babyfood 0.002200 14.300 0.100

0801379000 8A Tomato, juice 0.002200 1.500 0.100

0801380000 8A Tomato, Tree 0.002200 1.000 1.000

0802148000 8BC Eggplant 0.010000 1.000 1.000

0802234000 8BC Okra 0.010000 1.000 1.000

0802270000 8B Pepper, bell 0.010000 1.000 0.050

0802270001 8B Pepper, bell

- babyfood 0.010000 1.000 0.05 0

0802271000 8B Pepper, bell, dried 0.010000 1.000 0.050

0802271001 8B Pepper, bell, dried

- babyfood 0.010000 1.000 0.050

0802272000 8BC Pepper, nonbell 0.010000 1.000 0.050

0802272001 8BC Peppe r, nonbell

- babyfood 0.010000 1.000 0.050

0802273000 8BC Pepper, nonbell, dried 0.010000 1.000 0.050Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 27 of 29 0901075000 9A Cantaloupe 0.003500 1.000 1.000

0901187000 9A Honeydew melon 0.003500 1.000 1.000

0901399000 9A Watermelon 0.003500 1.000 1.000

0901400000 9A Watermelon, juice 0.003500 1.000 1.000

0902021000 9B Balsam pear 0.004000 1.000 1.000

0902088000 9B Chayote, fruit 0.006100 1.000 1.000

0902102000 9B Chinese waxgourd 0.004000 1.000 1.000

0902135000 9B Cucumber 0.004000 1.000 0.025 LOQ =

Full comment: LOQ = 0.02

0902308000 9B Pumpkin 0.006100 1.000 1.000

0902309000 9B Pumpkin, seed 0.006100 1.000 1.000

0902356 000 9B Squash, summer 0.006100 1.000 1.000 LOQ =

Full comment: LOQ = 0.02

0902356001 9B Squash, summer

- babyfood 0.006100 1.000 1.000

0902357000 9B Squash, winter 0.006100 1.00 0 1.000

0902357001 9B Squash, winter

- babyfood 0.006100 1.000 1.000

1100007000 11 Apple, fruit with peel 0.002000 1.000 0.100

1100008000 11 Apple, peeled fruit 0.002000 1.000 0.100

1100008001 11 Apple, peeled fruit

- babyfood 0.002000 1.000 0.100

1100009000 11 Apple, dried 0.002000 8.000 0.100

1100009001 11 Apple, dried

- babyfood 0.002000 8.000 0.100

1100010000 11 Apple, juice 0.002000 1.000 0.100

1100010001 11 Apple, juice

- babyfood 0.002000 1.000 0.100

1100011000 11 Apple, sauce 0.002000 1.000 0.100

1100011001 11 Apple, sauce

- babyfood 0.002000 1. 000 0.100

1100129000 11 Crabapple 0.002000 1.000 1.000

1100173500 11 Goji berry 0.002200 1.000 1.000

1100210000 11 Loquat 0.003000 1.000 1.000

1100266000 1 1 Pear 0.003000 1.000 0.050

1100266001 11 Pear

- babyfood 0.003000 1.000 0.050

1100267000 11 Pear, dried 0.003000 6.250 0.050

1100268000 11 Pear, juice 0.003000 1.000 0.050

1100268001 11 Pear, juice

- babyfood 0.003000 1.000 0.050

1100310000 11 Quince 0.003000 1.000 1.000

1304179000 13D Grape, wine and sherry 0.050000 0.290 1.000 MRID 4

Full comment: MRID 48758308

1400003000 14 Almond 0.020000 1.000 0.050

1400003001 14 Almond

- babyfood 0.020000 1.000 0.050

1400004000 14 Almond, oil 0.020000 1.000 0.050

1400004001 14 Almond, oil

- babyfood 0.020000 1.000 0.050

1400059000 14 Brazil nut 0.020000 1.000 1.000

1400068000 14 Butternut 0.020000 1.00 0 1.000

1400081000 14 Cashew 0.020000 1.000 1.000

1400092000 14 Chestnut 0.020000 1.000 1.000

1400155000 14 Hazelnut 0.020000 1.000 1.000

1400156000 14 Hazelnut, oil 0.020000 1.000 1.000

1400185000 14 Hickory nut 0.020000 1.000 1.000

1400213000 14 Macadamia nut 0.020000 1.000 1.000

1400269000 14 Pecan 0.020000 1.000 1.000

1400278000 14 Pine nut 0.020000 1.000 1.000

1400282000 14 Pistachio 0.020000 1.000 0.025

1400391000 14 Walnut 0.020000 1. 000 0.025

2003128000 20C Cottonseed, oil 0.025000 1.000 0.010

2003128001 20C Cottonseed, oil

- babyfood 0.025000 1.000 0.010

3100044000 31 Beef, meat 0.002000 1.000 0.100

3100044001 3 1 Beef, meat

- babyfood 0.002000 1.000 0.100

3100045000 31 Beef, meat, dried 0.002000 1.920 0.100

3100046000 31 Beef, meat byproducts 0.010000 1.000 0.100

3100046001 31 Beef, meat byproducts

- babyfood 0.010000 1.000 0.100

3100047000 31 Beef, fat 0.003000 1.000 0.100

3100047001 31 Beef, fat

- babyfood 0.003000 1.000 0.100

3100048000 31 Beef, kidney 0.004500 1.000 0.100

3100049000 31 Beef, liver 0.010000 1.000 0.100

3100049001 31 Beef, liver

- babyfood 0.010000 1.000 0.100

3200169000 32 Goat, mea t 0.002000 1.000 0.100

3200170000 32 Goat, meat byproducts 0.010000 1.000 0.100

3200171000 32 Goat, fat 0.003000 1.000 0.100

3200172000 32 Goat, kidney 0.004500 1.000 0.100

3200173000 32 Goat, liver 0.010000 1.000 0.100

3300189000 33 Horse, meat 0.002000 1.000 0.100Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 28 of 29 3400290000 34 Pork, meat 0.002000 1.000 0.010

3400290001 34 Pork, meat

- babyfood 0.002000 1.000 0.010

3400291000 34 Pork, skin 0.010000 1.000 0.010

3400292000 34 Pork, meat byproducts 0.010000 1.000 0.010

3400292001 34 Pork, m eat byproducts

- babyfood 0.010000 1.000 0.010

3400293000 34 Pork, fat 0.003000 1.000 0.010

3400293001 34 Pork, fat

- babyfood 0.003000 1.000 0.010

3400294000 34 Pork, kidney 0.004500 1.000 0.010

3400295000 34 Pork, liver 0.010000 1.000 0.010

3500339000 35 Sheep, meat 0.002000 1.000 0.100

3500339001 35 Sheep, meat

- babyfood 0.002000 1.000 0.10 0

3500340000 35 Sheep, meat byproducts 0.010000 1.000 0.100

3500341000 35 Sheep, fat 0.003000 1.000 0.100

3500341001 35 Sheep, fat

- babyfood 0.003000 1.000 0.100

3500342000 35 Sheep , kidney 0.004500 1.000 0.100

3500343000 35 Sheep, liver 0.010000 1.000 0.100

3600222000 36 Milk, fat 0.002000 1.000 0.100

3600222001 36 Milk, fat

- baby food/infant for mu 0.002000 1.000 0.100

3600223000 36 Milk, nonfat solids 0.000300 1.000 0.100

3600223001 36 Milk, nonfat solids

- baby food/in 0.000300 1.000 0.100

3600224000 36 Milk, water 0.000300 1.000 0.100

3600224001 36 Milk, water

- babyfood/infant form 0.000300 1.000 0.100

3600225001 36 Milk, sugar (lactose)

- baby food/ 0.000300 1.000 0.100

8601000000 86A Water, di rect, all sources 0.000150 1.000 1.000

8602000000 86B Water, indirect, all sources 0.000150 1.000 1.000Emamectin benzoate Dietary Exposure and Risk Assessment DP Number: D 430736

PC Code: 122806

______________________________________________________________________________________

Page 29 of 29 

### Attachment 6: Chronic Results File

US EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for EMAMECTIN BENZOATE NHANES 2003

- 2008 2

- day

Residue file name: C: \ Documents and Settings \ NDODD \ My Documents \ DEEM Version

3.16 \ Emamectin benzoate 121515 \ EMAMECTINCHRONICWine121515.R08

Adjustment factor #2 used.

Analysis Date 12

- 16

- 2015/10:25:49 Residue file dated: 12

- 16

- 2015/10:10:12

Reference dose (RfD, Chronic) = .0025 mg/kg bw/day

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

Total exposure by population subgroup

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

Total Exposure

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

Subgroup body wt/day Rfd

-------------------------------------- ------------- ---------------- Total US Population 0.000008 0.3%

Hispanic 0.000007 0.3%

Non

- Hisp

- White 0.000009 0.4%

Non

- Hisp

- Black 0.000007 0.3%

Non

- Hisp

- Other 0.000009 0.4%

Nursing Infants 0.000008 0.3%

Non

- Nursing Infants 0.000017 0.7%

Female 13+ PREG 0.000006 0.2%

Children 1

- 6 0.000011 0.4%

Children 7

- 12 0.000006 0.3%

Male 13

- 19 0.000005 0.2%

Female 13

- 19/NP 0.000004 0.2%

Male 20+ 0.000008 0.3%

Female 20+/NP 0.000010 0.4%

Seniors 55+ 0.000010 0.4%

All Infants 0.000014 0.6%

Female 13

- 50 0.000008 0.3%

Children 1

- 2 0.000014 0.5%

Children 3

- 5 0.000010 0.4%

Children 6

- 12 0.000007 0.3%

Youth 13

- 19 0.000005 0.2%

Adults 20

- 49 0.000008 0.3%

Adults 50

- 99 0.000009 0.4%

Female 13

- 49 0.000008 0.3%

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