Emamectin ben zoate PC Code : 122806 D i et ary Expos ure and Ri sk Assessment D P Numb e r : 0393838



### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , 

## D .C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM

Date: 19-DEC-2012

SUBJECT: Emamect in Benzoate: Revised Ac u te and Chronic Agg reg ate Dietar y (Foo d and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Actio n on Cucurbits and Ou t door -Gro wn Plants in Commercial Nursery Production

PC Code: 122806 D ec is ion No.: 452138 Petition N o.: I E7904 DP Barc ode: D39 383 8 Registration Nos.: 100-904

, 100-RURR Regulatory A ction: Sec ti on 3 Registration Case No.: NA Risk Assessme nt Type: NA TXRNo. : NA CAS No

. : 155569-91-8 (emamectin benzoate) 119791-4 I -2 ( emam ec tin)

MRIDNo.:NA 40 

### CFR: § 180.505

FROM: Nancy D odd, Che mi st -;

### d~**A -~C** **e../ /**  Ri sk Assessment Br anch 

## III (RAB3) Health E ffects Divi sion ( HED ; 7509 P )

< 

### THROUGH: Julie L. 

### Van Alstine, MP H

,

## Enviro**enta l**  Health Sc i entis t

## ~ Sheila Piper

, Chemist

### $"~**l.Ji~** Dietary Exposure Science Advisory Council ( DESAC) HED (750 9P) and Jeff Dawson

, Acting Branch Chief RA B 31HED (7509P)

TO: B arbara M adden/ Andrew Ertman

, RM #5 Registration Division ( RD ; 7505P)

P age l of30Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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### Executive Summary

Acute and chronic aggregat e dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-F CID), Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examina tion Survey, What We Eat in America (NHANES/WWEIA). The analyses were conducted in support of a human health risk assessment for the proposed Section 3 use of emamectin benzoate on cucurbits. This memorandum was reviewed by two peer revi ewers of the DESAC, per the current DESAC Standard Operating Procedure (SOP).

Acute Dietary (Food and Drinking Water) Ex posure Results and Characterization

A probabilistic acute dietary exposure a ssessment was conducted. The anticipated residue estimates, used for most crops, were based on field trial da ta. Tolerance-level residues were used for tree nuts (including pist achios) and cottonseed oil. Pesticide Data Program (PDP) monitoring data for years 2009 and 2010 were used for apples since apple juice had a significant impact on exposure. D EEM default processing factors were used except for commodities with chemical-specific processing studies. Percent crop treated (% CT) data and percent cr op treated data for new cr ops (PCTn) provided by the Biological and Economic Analysis Division (B EAD) in 2012 were used. The estimated drinking water concentrations (EDWCs) of emamectin benzoate were provided by the Environmental Fate and Effect s Division (EFED). A drinking water residue distribution based on the Pesticide Root Zone M odel/Exposure Analysis Modeling System (PRZM/EXAMS) modeling of the use on orname ntals was used in the acute assessment.

The acute dietary exposure estimates for f ood and drinking water using the ornamentals scenario for drinking water are belo w HED’s level of concern at the 99.9 th 

### percentile of exposure for all population subgroups (36% of the aPAD for the general U.S. population and 60% of the aPAD for children 1-2 years old).

Chronic Dietary (Food and Dr inking 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 used fo r tree nuts (including pistachios) and cottonseed oil. DEEM defa ult processing factors were used except for commodities with chemical-specific processing studies. Percent crop treated data and PCTn data provided by BEAD in 2012 were us ed. The EDWC of 0.150 μg/L (ppb) for the chronic exposure was based on PRZM/EXA MS modeling of the use on ornamentals, which resulted in the highest chronic EDWC considering all proposed/registered uses.

The chronic dietary exposure estimates for food and drinking water using the ornamentals scenario for drinking water are below HE D’s level of concern for all populationEmamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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### subgroups (7.5% of the cPAD for the genera l U.S. population and 16% of the cPAD for all infants less than 1 year old).

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

Emamectin benzoate is classifi ed as “not likely to be car cinogenic to humans” based on the rodent carcinogenicity studies.

I. Introduction

Dietary risk assessment incorpor ates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED ha s concluded will result in no unreasonable adverse health effects). This dose is refe rred to as the population adjusted dose (PAD). The PAD is equivalent to point of depart ure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chroni c exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References 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.epa.gov/fedrgstr/E PA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-AUG-1999).

This revised assessment uses DEEM Version 3.16; the previous assessment (N. Dodd, DP No. D393838, 8/29/12) used the older DEEM Version 2.03. Other than the 8/29/12 memo, the most recent dietary risk assessm ent for emamectin benzoate was conducted by Nancy Dodd (24-JUL-2008, D347924 and addendum 22-JAN-2009, D360696).

II. Residue Information

Tolerances : Tolerances for plant commodities have been established under 40 CFR §180.505(a)(1) for the combined residues of emam ectin (a mixture of a minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin B 1a 

### and maximum of 10% 4'-epi-methylamino4'-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'-epiamino-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)aminoavermectin B 1a 

### (FAB 1a 

### ) at levels ranging fr om 0.02 ppm to 0.20 ppm.

Tolerances for livestock commodities have been established under 40 CFR §180.505(a)(2) for the combined residues of emamectin (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 m eat of cattle, goat, horse, and sheep; 0.020 ppm for the meat byproducts except liver of cattle, goat, horse, and sheep; 0.003 ppm forEmamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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### hog fat; 0.020 ppm for hog liver; 0.002 pp m for hog meat; 0.005 ppm for hog meat byproducts except liver; and 0.003 ppm for milk. No tolerances have been established for poultry commodities.

Residues of Concern: The residues of concern in plan ts 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 expre ssion and dietary risk assessment.

Residues in Crops :

Acute assessment: A probabilistic acute dietary exposure assessment was conducted. The anticipated residue estimates, used for mo st crops, were based on field trial data. The anticipated residues for the cucurbits subg roup 9A are shown in Table 1 below. The maximum residue for cantaloupe (0.0046 ppm) was used for the cucurbits subgroup 9A ( HED Standard Operating Procedures 2000.1 , 9/12/2000). Anticipat ed residues for the cucurbits subgroup 9B were based on the L OD’s for cucumber (0.004 ppm) and squash (0.0061 ppm). Tolerance-level residues were us ed for tree nuts (inc luding pistachios) and cottonseed oil. Pesticide Data Program (PDP) monitoring data for years 2009 and 2010 were used for apples since apple juice ha d a significant impact on exposure. DEEM default processing factors were used except for commodities with chemical-specific processing studies. Percent crop treated da ta and PCTn data pr ovided by the BEAD in 2012 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 (averages) based on field trial da ta. The anticipated residues for cucurbits subgroup 9A are shown in Table 1 below. The average residue for cantaloupe (0.0032 ppm) was used for the cucurbits subgroup 9A ( HED Standard Operating Procedures 2000.1 , 9/12/2000). Anticipated residues for th e cucurbits subgroup 9B were based on the LODs for cucumber (0.004 ppm) and squa sh (0.0061 ppm). Tolerance-level residues were used for tree nuts (including pistach ios) and cottonseed o il. DEEM default processing factors were used except for comm odities with chemical-specific processing studies. Percent crop treated data and PCTn data provided by BEAD in 2012 were used.Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 5 of 30 Table 1. Emamectin Benzoate Anticipate d Residues for Cucurbits Subgroup 9A

No. of Trials Residues (ppm) 1

MAB 1a MAB 1b 8,9-Z isomers AB 1a MFB 1a FAB 1a Combined residues 2
Cantaloupe 4 0.0005 0.0005 0.0005 0.0005 0.0005 0.0005 0.0030

1 0.0011 0.0005 0.0005 0.0005 0.0005 0.0005 0.0036

1 0.0015 0.0005 0.0005 0.0005 0.0005 0.0005 0.0040

1 0.0012 0.0005 0.0005 0.0005 0.0005 0.0005 0.0037

1 0.00075 0.0005 0.0005 0.0005 0.0005 0.0005 0.0032

1 0.0026 0.0005 0.0005 0.0005 0.0005 0.0005 0.0051

1 0.0012 0.0005 0.0005 0.0005 0.0005 0.0005 0.0037

1 The LOQ was 0.001 ppm for each analyte. Per-trial averages were calculated using the 1⁄2 LOQ for all residues reported as <LOQ.

2 Combined residues include total emamectin (MAB 1a and MAB 1b ), its 8,9-Z isomers (8,9-ZB 1a and 8,9- ZB 1b ), and metabolites/degradates AB 1a , MFB 1a , and FAB 1a . The average is 0.0035 ppm.



### Pesticide Data Program (PDP) monitoring da ta for apples were used in the acute assessment since apple juice has a significan t impact on exposure. The total number of apple samples from years 2009 and 2010 was 1278 with no detects at a limit of detection of 0.001 ppm.

Processed Commodities: Processing studies are ava ilable on apples (MRID 45899801), tomatoes (MRID 46587002), and cottonseed (MRID 44883716). The studies show that residues do not concentrate in apple juice, to mato paste, tomato puree, and cottonseed oil; therefore, a processing factor of 1.0x is used for these commodities. The apple juice result is translated to pear juice (1.0x). DEEM default pr ocessing factors are applied to other processed commodities: apples, dried (8.0x); pears, dried (6.25x); tomato juice (1.5x); tomato, dried (14.3x); and beef, meat, dried (1.92x).

Meat, Milk, Poultry, and Eggs: Residues in livestock commodities are based on the livestock dietary burdens from Table 2 a nd the feeding study results from Table 3.Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 6 of 30 Table 2. Livestock Maximum Reasonable Dietary Burdens for Emamectin Benzoate 1 % Diet Dietary Contributions (ppm) Feedstuff Type Tolerance,

ppm % Dry Matter Beef Dairy Poultry Swine Beef Dairy Poultry Swine

Almond hulls R 0.055 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 0.028 0.0056 0.0042

1 All data are based on Table 1 Feedstuffs (June 2008). Residue levels for beef and dairy cattle are corrected for moisture content and are determined by the following formula: tole rance ÷ % dry matter x % in diet. Residue levels for poultry and swine are co nsidered “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 MRID 47243301) is used for dairy cattle feed items. The HAFT of 0.0985 ppm would be used for beef cattle, poultry, or swine.



### An 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 pr esented in Table 3 below. The reported LODs and LOQs for each analyte were 0.001 and 0.002 ppm, respectively, in liver, kidney, muscle, and fat; 0.0001 and 0.0005 ppm, respectiv ely, in milk (whole and skim); and 0.00025 and 0.0005 ppm, respectively, in cream.

Since all dietary burdens in Table 2 above ar e <0.03 ppm, the residues from the low dose (0.03 ppm) cattle feeding study were used in the dietary assessments as the residue levels in livestock commodities. Component residues used in the dietary assessment for whole milk and cream are bolded in Table 3 below. Component residues used for fat, kidney, liver, and meat (muscle) are also bolded. Fo r residues reported as <LOD or <LOQ, 1⁄2 the LOD or 1⁄2 the LOQ was used to sum the compon ent 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 byproducts 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.Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 7 of 30 Table 3. Maximum Residues Observed in Ca ttle Matrices 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 catfish/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 Diet ary (Food + Drinking Water) Assessment:

A probabilistic acute dietary exposure a ssessment was conducted. The anticipated residue estimates, used for most crops, were based on field trial data. The anticipated residues for the cucurbits subgroup 9A are shown in Table 1 above. The maximum residue for cantaloupe (0.0051 ppm) was used for the cucurbits subgroup 9A ( HED Standard Operating Procedures 2000.1 , 9/12/2000). Anticipated residues for the cucurbits subgroup 9B were based on the L OD’s for cucumber (0.004 ppm) and squash (0.0061 ppm). Tolerance-level residues were us ed for tree nuts (inc luding pistachios) and cottonseed oil. Pesticide Data Program (PDP) monitoring data for years 2009 and 2010 were used for apples since apple juice ha d a significant impact on exposure. DEEM default processing factors were used excep t for commodities with available chemicalspecific processing studies. Percent crop tr eated data and PCTn data provided by BEAD in 2012 were used. The EDWCs of emamectin benzoate were provided by EFED. A drinking water residue distri bution based on the PRZM/EXA MS modeling of the use on ornamentals was used in the acute assessment.Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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### Residue Data used for the Chronic Di etary (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. The anticipated re sidues for cucurbits subgroup 9A are shown in Table 1 above. The average residue fo r cantaloupe (0.0035 ppm) was used for the cucurbits subgroup 9A ( HED Standard Operating Procedures 2000.1 , 9/12/2000). Anticipated residues for the cucurbits subgroup 9B were based on the LODs for cucumber (0.004 ppm) and squash (0.0061 ppm). Tolerance-level residues were used for tree nuts (including pistachios) and cottonseed oil. DEEM default processing factors were used except for commodities with chemical-specific processing studies. Percent crop treated data and PCTn data provided by BEAD in 2012 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 th e highest chronic EDWC considering all proposed/registered uses.

III. Percent Crop Treated Information

A screening level usage analysis (SLUA) dated 5/29/12 was provided by BEAD based on data years 2003-2010. A PCTn analysis was also provided by BEAD (DP#403689, J. Alsadek, Ph.D., 8/21/12). (Refer to Attach ment 2). The estimated maximum percent crop treated for each of sixteen crops was used for the acute dietary risk assessment and the estimated weighted average percent crop tr eated was used for the chronic dietary risk

assessment.

The following maximum percent crop treated es timates (SLUA, 5/29/12) were used in the acute dietary risk assessment for the following crops that are currently registered for emamectin benzoate: almonds: 2.5%; appl es: 20%; broccoli: 20%; cabbage: 25%; cauliflower: 20%; celery: 40%; cotton: 2.5%; lettuce: 20%; pe ars: 20%; peppers: 15%; spinach: 10%; and tomatoes: 20%.

The following maximum PCTn estimates (D P#403689, J. Alsadek, Ph.D., 8/21/12) were used in the dietary risk assessment for the following crops that are the subject of this petition for residues of emamectin benzoate : cantaloupe: 51%; cu cumber: 26%; squash: 46%; and watermelon: 21%.

The following average percent crop treated esti mates (SLUA, 5/29/12) were used in the acute dietary risk assessment for the followi ng crops that are currently registered for emamectin benzoate: almonds: 1%; appl es: 10%; broccoli: 5%; cabbage: 10%; cauliflower: 10%; celery: 25%; cotton: 1%; lettuce: 10%; pears: 5%; peppers: 5%; spinach: 5%; and tomatoes: 10%.

The following average PCTn estimates (D P#403689, J. Alsadek, Ph.D., 8/21/12) were used in the dietary risk assessment for the following crops that are the subject of this petition for residues of emamectin benzoate : cantaloupe: 40%; cu cumber: 14%; squash: 29%; and watermelon: 19%.Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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### For livestock commodities, percent crop treated for apples was used for beef and dairy cattle; percent crop treated for cotton (the on ly poultry/swine feed item) was used for swine.

IV. Drinking Water Data

The drinking water residues used in the di etary risk assessment were provided by EFED in the following memorandum: “ Amended Drinking Water Assessment for the proposed use of Emamectin Benzoate on outdoor ornamentals and Group 9 cucurbit vegetables” (DP#402307, Tiffany Dowen, 5/30/12) and inco rporated directly into this dietary assessment. Water residues were in corporated in the DEEM-FCID into the food categories “water, direct, all sources” a nd “water, indirect, all sources.”

EFED provided EDWCs for the proposed/reg istered uses of emamectin benzoate including the proposed uses on outdoor or namentals (EPA 100-RURR) and cucurbit vegetables (EPA 100-904). 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 for 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 annua l average (Table 4). A di stribution 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 av ermectin 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 drinki ng water assessment for emamectin benzoate and are assumed to be of equal or lesser to xicity to that of the parent compound. The total toxic residues approach is used for determining the environmental 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 To tal Toxic Residues (TTR), dated May 20, 2009.Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 10 of 30 Table 4. EDWCs for Emamectin Be nzoate Residues from Use on Ou tdoor 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 -3

1 Degradates of concern included in the calculati on of EDWCs: (8,9-Z)-4"-epimethylamino-4"-deoxy avermectin B1, 4"-epiamino-4"-d eoxyavermectin B1, avermectin 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 guidance.



### The model and its description are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.

V. DEEM-FCIDTM Program and Consumption Information

Emamectin benzoate acute and chronic di etary exposure assessments were conducted using DEEM-FCID, Version 3.16, which incor porates 2003-2008 consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consumption of more than 20,000 individuals over tw o non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files develope d jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups. However, fo r acute exposure assessment, consumption data are retained as individual consumption events. Based on an alysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to re port risk for the following population subgroups: the general U.S. population, all infants (< 1 year old), children 1-2, children 3-5, childre n 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years old.

For chronic dietary exposure assessment, an esti mate of the residue le vel in each food or food-form (e.g., orange or orange juice) on th e food commodity residue list is multiplied by the average daily consumption estimate fo r 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 residueEmamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 11 of 30 

### list to arrive at the total av erage 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 a nd summed to obtain a total daily pesticide exposure for a deterministic exposure asse ssment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of expos ures is expressed as a perc entage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a percapita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for analyses performed at all levels of refineme nt. However, for deterministic assessments, any significant differences in user vs. pe r capita exposure and ri sk are specifically identified and noted in the risk assessment.

VI. Toxicological Information

The HED Risk Assessment Team confirmed e ndpoints that were previously selected ( Emamectin Benzoate. Human Health A ssessment Scoping Document in Support of Registration Review , D385990, N. Dodd, N. Tsaur, and W. Phang, 6/16/11; HIARC’s February 26, 1998, July 28 and August 3, 1998, and March 5, 2003 evaluations of the emamectin toxicity database). The endpoint s and uncertainty factors (UFs) selected by HED’s HIARC in 2003 remain unchanged; howev er, under the current data requirement guidelines, immunotoxicity data (OCSPP 870.78 00) and a subchronic inhalation study (OCSPP 870.3465) are required.

Although HED concluded that there is a low degree of concern and lack of residual uncertainties for pre- and post-natal toxicity, th e 10X FQPA safety fact or (SF) is retained for chronic assessments while a 3X FQPA SF is adequate for acute assessments.

A 10X FQPA SF has been retained for th e chronic assessment to account for the steepness of the dose response curve, severi ty of effects at the LOAEL (death and neuropathology), and most importantly the use of a short-term study for long term risk assessment. The 10X FQPA SF will also provide adequate protection for the lack of the new immunotoxicity study. A 3X FQPA SF ha s been retained for the acute assessment to account for the steepness of the dose-respons e curve and severity of effects at the LOAEL (death and neuropathology).

The doses and toxicological e ndpoints selected for use in dietary exposure assessments are summarized in Table 5.Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 12 of 30 Table 5. Summary of Toxicological Doses and Endp oints for Emamectin benzoate for Use in Dietary Exposure Assessments Exposure/ Scenario Point of Departure Uncertainty/ FQPA Safety Factors RfD, PAD, Level of Concern for Risk Assessment Study and Toxicological Effects

Acute Dietary (All Populations) NOAEL= 0.075 mg/kg/day UF A = 10x UF H = 10x FQPA SF=3x Acute RfD = 0.00025 mg/kg/day

aPAD =0.00025mg/kg /day 15-day mouse LOAEL = 0.1 mg/kg/day based on tremors on day 3 of dosing.

Chronic Dietary (All Populations) NOAEL= 0.075 mg/kg/day UF A =10x UF H =10x FQPA SF=10x Chronic RfD = 0.000075 mg/kg/day

cPAD = 0.000075 mg/kg/day 15-day mouse LOAEL = 0.1mg/kg/day based on moribund sacrifices, clinical signs of neurotoxicity, decreases in body weight and food consumption and histopathological lesions in the sciatic nerve. Cancer (oral, dermal, inhalation) Classification: “Not likely to be Carcinogenic to Humans” based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies.

Point of Departure (POD) = A data point or an estimate d point that is derived from observed dose-response data and used to mark the beginning of extra polation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.



### VII. 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 subg roups. The results reported in Tables 6 and 7 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 adu lts 50-99 years.

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

The results of the acute dietary (food + dr inking water) exposure analysis at the 95 th 

### , 99 th



### , and 99.9 th 

### percentiles of exposure ar e reported in Table 6. 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, at 36% of the aPAD for the general U.S. population and 60% of the aPAD for children 1-2 years old, the most highly exposed subgroup.Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 13 of 30 Table 6. Results of Acute Dietary (Food and Dr inking 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 0.00025 0.000019 7.4 0.000038 15 0.000091 36

All Infants (< 1 year old) 0.000037 15 0.000070 28 0.000138 55

Children 1-2 years old 0.000038 15 0.000074 29 0.000151 60

Children 3-5 years old 0.000028 11 0.000059 23 0.000135 54

Children 6-12 years old 0.000018 7.3 0.000042 17 0.000082 33

Youth 13-19 years old 0.000012 4.8 0.000025 10 0.000084 33

Adults 20-49 years old 0.000016 6.5 0.000032 13 0.000077 31

Adults 50-99 years old 0.000018 7.3 0.000035 14 0.000093 37

Females 13-49 years old 0.000016 6.5 0.000033 13 0.000076 30

1 The population with the highest exposure is bolded.



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

The results of the chronic dietary (food and drinking wa ter) exposure analysis are reported in the summary table below. For the chronic dietary assessment, all population subgroups have risk estimates which are belo w 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 s ubgroups, at 7.5% of the cPAD for the general U.S. population and 16% of the cPAD for all infant s (<1 year old), the most highly exposed subgroup.Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 14 of 30 Table 7. Summary of Dietary (Food and Dri nking Water) Exposure an d 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 0.000091 36 0.000006 7.5 All Infants (<1 year old)* 0.000138 55 0.000012 16 Children 1-2 years old* 0.000151 60 0.000011 15 Children 3-5 years old 0.000135 54 0.000009 12 Children 6-12 years old 0.000082 33 0.000006 7.4 Youth 13-19 years old 0.000084 33 0.000004 5.2 Adults 20-49 years old 0.000077 31 0.000005 6.9 Adults 50-99 years old 0.000093 37 0.000006 7.7 Females 13-49 years old 0.000076 30 0.000005 6.8 *The subpopulations with the high est risk estimates are bolded.



### VIII. Characterization of Inputs/Outputs

The acute and chronic assessments for food incorporate somewhat refined anticipated residue estimates for most commodities that were derived from fi eld trial data and %CT/PCTn data. Monitoring data were used for apples in the acute assessment since apple juice had a significant impact on exposur e. The use of more monitoring data and food preparation-reduction fact ors for washing, cooking, etc. may have resulted in more refined estimates of dietary exposure. More hi ghly refined analyses are not needed at this time since the risk estimates are below HED’s level of concern.

IX. 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 mo st crops were based on field trial data, incorporated percent crop treated or PCTn estimates provided by BEAD, and processing factors where appropriate. PD P monitoring data were used for apples. A drinking water residue distribution based on th e use on ornamentals was used in the acute assessment. The acute dietary exposure estimates for f ood and drinking water are below HED’s level of concern at the 99.9 th 

### percentile of exposure for all population subgroups (36% of the aPAD for the general U.S. population and 60% of the aPAD for children 1-2 years old).Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 15 of 30 

### The chronic dietary exposure assessment is a somewhat refined assessment conducted for all proposed/registered food us es of emamectin benzoate and drinking water. The anticipated residue estimates used for most crops were single point estimates (averages) based on field trial data, incor porated percent crop treated or PCTn estimates provided by BEAD, and processing factors where appr opriate. An EDWC based on the use on ornamentals was used in the chronic assessment. The chronic dietary exposure estimates for food and drinking water are below HED’ s level of concern for all population subgroups (7.5% of the cPAD for the genera l U.S. population and 16% of the cPAD for all infants less than 1 year old).

X. List of Attachments

Attachment 1: Acute Residue Distributi on Files and Chronic Point Estimates. Attachment 2: Percent Crop Treated Memos 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. Attachment 6: Chronic Results File.

cc: N. DoddEmamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 16 of 30 

### Attachment 1: Acute Residue Distribu tion Files and Chronic Point Estimates

RDF 1 'Apple, PDP Data, 20%CT TOTALZ=1022 TOTALLOD=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 20%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 25%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 an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 17 of 30 RDF 5 ‘Cauliflower Field trial data 20%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 TOTALZ=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 0.10= 0.0002 Chronic= 0.0065 x 0.25= 0.0016 Chronic= 0.0036 x 0.10= 0.0004 Chronic= 0.017 x 0.10= 0.002Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 18 of 30 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=68 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 20%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

0.010 0.010 0.011 0.011 0.011 0.012

Chronic= 0.017 x 1= 0.02 Chronic= 0.010 x 0.05= 0.0005 Chronic= 0.0030 x 0.05= 0.00015 Chronic= 0.011 x 0.05= 0.00055Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 19 of 30 RDF 13 ‘Tomato Field trial data 20%CT TOTALZ=124 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 [apple 20%CT] TOTALZ=80

20,0.0003 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= 0.0003 x 0.10 = 0.00003 Chronic= 0.003 x 0.10= 0.0003 Chronic= 0.01 x 0.10= 0.001Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 20 of 30 RDF 17 'Cattle meat [apple 20%CT] TOTALZ=80

20,0.002 RDF 18 'Cattle meat byproduct [apple 20%CT] TOTALZ=80

20,0.01 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= 0.0002 Chronic= 0.01 x 0.10= 0.001 Chronic = 0.003 x 0.01 = 0.00003 Chronic = 0.01 x 0.01 = 0.0001

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 [apple 20%CT] TOTALZ=80

20,0.002 RDF 24 ‘Cantaloupe Field trial data 51%CT TOTALZ=10 TOTALNZ=10 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 = 0.0001 Chronic = 0.002 x 0.10 = 0.0002 Chronic = 0.0035 x 0.40 = 0.0014

RDF 25 ‘Cucumber Field trial data 26%CT TOTALZ=23 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 46%CT TOTALZ=9 TOTALNZ=8 0.0061 0.0061 0.0061 0.0061 0.0061 0.0061 0.0061 0.0061 RDF 27 ‘Winter Squash Field Trial data 46%CT TOTALZ=9 TOTALNZ=8 0.0061 0.0061 0.0061 0.0061 0.0061 0.0061 0.0061 0.0061 RDF 28 ‘Watermelon Cantaloupe field trial data 21%CT TOTALZ=38 TOTALNZ=10 0.0030 0.0030 0.0030 0.0030 0.0036 0.0040 0.0037 0.0032 0.0051 0.0037

Chronic = 0.004 x 0.14 = 0.00056 Chronic = 0.0061 x 0.29 = 0.0018 Chronic = 0.0061 x 0.29 = 0.0018 Chronic = 0.0035 x 0.19 = 0.00066Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 21 of 30 RDF 29 Almond 2.5%CT TOTALZ=97

3,0.02 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 0.0037 RDF 32 Ormamentals Drinking Water

Chronic = 0.02 x 0.01 = 0.0002 Chronic = 0.0045 x 0.10 = 0.00045 Chronic = 0.0035 x 1 = 0.0035 Chronic = 0.000150

RDF 33 Hog kidney [cotton 2.5%CT] TOTALZ=97

3, 0.0045

Chronic = 0.0045 x 0.01 = 0.000045Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 22 of 30 

### Attachment 2: Percent Cr op Treated Memos from BEAD

A screening level usage analysis (SLUA) dated 5/29/12 was provided by BEAD based on data years 2003-2010. The following data were excerpted from the 5/29/12 SLUA.

Screening Level Estimates of Agricultural Us es of Emamectin Benzoate (5/29/12)
Crop Percent Crop Treated Average Maximum Almonds <1 <2.5 Apples 10 20 Broccoli 5 20 Cabbage 10 25 Cauliflower 10 20 Celery 25 40 Cotton <1 <2.5 Lettuce 10 20 Pears 5 20 Peppers 5 15 Spinach 5 10 Tomatoes 10 20

The following PCTn data were provided by BEAD (DP#403689, J. Alsadek, Ph.D., 8/21/12):

PCTn Data for Agricultural Uses of Emamectin Benzoate (8/21/12) Crop PCTn Average Maximum Cantaloupe 40 51 Cucumber 14 26 Squash 29 46 Watermelon 19 21Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 23 of 30 

### Attachment 3: Acute Food pl us Water Residue Input File

Filename: C:\Documents and Settings\NDODD\My Documents\DEEM Version 3.16\emamectin benzoate 2013\EMAMECTINACUTECUCURBITS121212.R08 Chemical: Emamectin Benzoate RfD(Chronic): 0 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .00025 mg/kg bw/day NOEL(Acute): .075 mg/kg bw/day Date created/last modified: 12-19-2012/12:51:40 Program ver. 3.16, 03-08-d Comment: General Population; include pome fruits + drinking water

----------------------------------------------------------------------------------- RDL indices and parameters for Monte Carlo Analysis: Index Dist Parameter #1 Param #2 Param #3 Comment # 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

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 0401133000 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 Endive 0.012000 1.000 1.000 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 12 0401355001 4A Spinach-babyfood 0.012000 1.000 1.000 12 0402076000 4B Cardoon 0.012100 1.000 1.000 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 1.000Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 24 of 30 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 0501069000 5A Cabbage 0.004000 1.000 1.000 4 0501071000 5A Cabbage, Chinese, napa 0.004000 1.000 1.000 0501072000 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 Broccoli 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 0.005000 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-babyfood 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 0901399000 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 1 1100010001 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 Crabapple 0.009055 1.000 1.000 1100173500 11 Goji berry 0.005000 1.000 1.000Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 25 of 30 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 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 0.025 B 1400004001 14 Almond, oil-babyfood 0.020000 1.000 0.025 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 1400391000 14 Walnut 0.020000 1.000 1.000 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 3200170000 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 1.000 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 14 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 an d Risk Assessment DP Number: D393838 PC Code: 122806

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### Attachment 4: Acute Results File

U.S. EPA Ver. 3.16, 03-08-d DEEM-FCID ACUTE Analysis for EMAMECTIN BENZOATE NHANES 2003-2008 2-Day Residue file: EMAMECTINACUTECUCURBITS121212.R08 Adjustment factor #2 used. Analysis Date: 12-19-2012/13:04:38 Residue file dated: 12-19-2012/12:51:40 NOEL (Acute) = 0.075000 mg/kg body-wt/day RAC/FF intake summed over 24 hours MC iterations = 1000; MC list in residue file; MC seed = 4; RNG = MS VB Run Comment: "General Population; include pome fruits + drinking water"

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Summary calculations--per capita:

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

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.000019 7.44 4030 0.000038 15.14 1981 0.000091 36.35 825 All Infants: 0.000037 14.79 2027 0.000070 28.16 1065 0.000138 55.17 543 Children 1-2: 0.000038 15.25 1967 0.000074 29.47 1018 0.000151 60.35 497 Children 3-5: 0.000028 11.29 2657 0.000059 23.44 1279 0.000135 53.93 556 Children 6-12: 0.000018 7.32 4099 0.000042 16.70 1796 0.000082 32.98 909 Youth 13-19: 0.000012 4.85 6190 0.000025 10.09 2973 0.000084 33.47 896 Adults 20-49: 0.000016 6.52 4599 0.000032 12.96 2315 0.000077 30.78 974 Adults 50-99: 0.000018 7.31 4104 0.000035 14.10 2127 0.000093 37.32 803 Female 13-49: 0.000016 6.48 4627 0.000033 13.19 2274 0.000076 30.48 984Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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### Attachment 5: Chronic Food pl us Water Residue Input File

Filename: C:\Documents and Settings\NDODD\My Documents\DEEM Version 3.16\emamectin benzoate 2013\EMAMECTINCHRONICCUCURBITS 121212.R08 Chemical: Emamectin Benzoate RfD(Chronic): .000075 mg/kg bw/day NOEL(Chronic): .075 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 12-19-2012/12:52:17 Program ver. 3.16, 03-08-d Comment: General Population; include pome fruits + drinking water

----------------------------------------------------------------------------------- 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 1.000 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 0.250 0402085001 4B Celery-babyfood 0.006500 1.000 0.250 0402086000 4B Celery, juice 0.006500 1.000 0.250 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 0.050 0501062000 5A Broccoli, Chinese 0.003000 1.000 1.000 0501064000 5A Brussels sprouts 0.002000 1.000 1.000 0501069000 5A Cabbage 0.002000 1.000 0.100 0501071000 5A Cabbage, 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 0.100 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 greens 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 0.050 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 Pepper, nonbell-babyfood 0.010000 1.000 0.050Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 28 of 30 0802273000 8BC Pepper, nonbell, dried 0.010000 1.000 0.050 0901075000 9A Cantaloupe 0.003500 1.000 0.400 0901187000 9A Honeydew melon 0.003500 1.000 1.000 0901399000 9A Watermelon 0.003500 1.000 0.190 0901400000 9A Watermelon, juice 0.003500 1.000 0.190 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 0.140 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 0902356000 9B Squash, summer 0.006100 1.000 0.290 LOQ = Full comment: LOQ = 0.02 0902356001 9B Squash, summer-babyfood 0.006100 1.000 0.290 0902357000 9B Squash, winter 0.006100 1.000 0.290 0902357001 9B Squash, winter-babyfood 0.006100 1.000 0.290 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 11 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 1400003000 14 Almond 0.020000 1.000 0.010 1400003001 14 Almond-babyfood 0.020000 1.000 0.010 1400004000 14 Almond, oil 0.020000 1.000 0.010 1400004001 14 Almond, oil-babyfood 0.020000 1.000 0.010 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 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 1400282000 14 Pistachio 0.020000 1.000 1.000 1400391000 14 Walnut 0.020000 1.000 1.000 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 31 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, meat 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 0.100 3400290000 34 Pork, meat 0.002000 1.000 0.010 3400290001 34 Pork, meat-babyfood 0.002000 1.000 0.010Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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Page 29 of 30 3400291000 34 Pork, skin 0.010000 1.000 0.010 3400292000 34 Pork, meat byproducts 0.010000 1.000 0.010 3400292001 34 Pork, meat 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 0.100 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 formu 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, direct, all sources 0.000150 1.000 1.000 8602000000 86B Water, indirect, all sources 0.000150 1.000 1.000Emamectin benzoate Dietary Exposure an d Risk Assessment DP Number: D393838 PC Code: 122806

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### Attachment 6: Chronic Results File

U.S. 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 2013\EMAMECTINCHRONICCUCURBITS 121212.R08 Adjustment factor #2 used. Analysis Date 12-19-2012/12:54:01 Residue file dated: 12-19-2012/12:52:17 Reference dose (RfD, Chronic) = .000075 mg/kg bw/day COMMENT 1: General Population; include pome fruits + drinking water

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

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Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Population 0.000006 7.5% Hispanic 0.000005 7.0% Non-Hisp-White 0.000006 7.5% Non-Hisp-Black 0.000006 7.7% Non-Hisp-Other 0.000007 9.2% Nursing Infants 0.000006 7.5% Non-Nursing Infants 0.000014 19.0% Female 13+ PREG 0.000005 6.9% Children 1-6 0.000009 12.6% Children 7-12 0.000005 7.0% Male 13-19 0.000004 5.1% Female 13-19/NP 0.000004 5.2% Male 20+ 0.000005 6.8% Female 20+/NP 0.000006 7.6% Seniors 55+ 0.000006 7.5% All Infants 0.000012 15.5% Female 13-50 0.000005 6.8% Children 1-2 0.000011 15.3% Children 3-5 0.000009 11.5% Children 6-12 0.000006 7.4% Youth 13-19 0.000004 5.2% Adults 20-49 0.000005 6.9% Adults 50-99 0.000006 7.7% Female 13-49 0.000005 6.8%

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