Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

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### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES , AND TOXIC SUBSTANCES 

### MEMORANDUM D ATE : 23 - FEB - 2010 S UBJECT : Novaluron. Chronic Dietary (Food and Drinking Water) Exposure and Risk

Assessment for the Proposed Use in/on Grain Sorghum . PC Code: 124002 DP Barcode: D374419 Decision No.: 407899 Registration No. : 66222 - 35 - 400 Petition No.: 9F7547 Regulat ory Action: Section 3 Registration Risk Assessment Type: Dietary Exposure Case No.: NA T XR No.: NA CAS No.: 116714 - 46 - 6 MRID No.: NA 40 CFR: § 180.598 

### FROM : Julie L . Van Alstine , MPH , Environmental Health Scientist

Risk Assessment Branch 1 (RAB 1)/Health Effects Division (HED) (7509P) THROUGH: William Cutchin, Chemist

Tom Bloem, Chemist Dietary Exposure Science Advisory Council (DESAC) HED (7509P) and George F. Kramer, Ph.D., Branch Senior Chemist RAB1/HED (7509P) TO: Julie L . Van Alstin e , Risk Assessor

RAB1/HED (7509P) and John Hebert (RM 07)/ Jennifer Gaines Registration Division (RD; 7505P)Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

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### Executive Summary A chronic aggregate dietary (food and drinking water) exposure and risk assessment was conducted using the Dietary Exposur e Evaluation Model software with the Food Commodity Intake Database (DEEM - FCID  , Version 2.03), which uses food consumption data from the U.S. Department of Agriculture’s (USDA’s ) Continuing Surveys of Food Intakes by Individuals (CSFI I) from 1994 - 1996 and 1998. The analysis was performed to support a Section 3 request for use of novaluron on grain sorghum. Acute Dietary

(Food and Drinking Water) Exposure Results and Characterization An acute dietary

assessment was not conducted for novaluron because an endpoint of concern attributable to a single dose was not identified. Chronic Dietary

(Food and Drinking Water) Exposure Results and Characterization A chronic dietary

(food and drinking water) exposure and risk assessment was conducted for the propos ed new use on grain sorghum , all established uses , and drinking water. A partially refined assessment was conducted. EFED provided the estimated drinking water concentrations (EDWCs) which were incorporated into the analysis. A Screening Level Usage Ana lysis (SLUA) memorandum for existing uses and a percent crop treated for new use (PCTn) memorandum for sorghum were provided by the Biological and Economic Analysis Division (BEAD). The chronic analysis incorporated average percent crop treated ( %CT ) data for apples, cabba ge, cotton, pears, and potatoes and PCTn data for grain sorghum. 100% CT was assumed for the remaining food commodities. Anticipated residues (ARs) for meat, milk, hog, and poultry commodities were calculated using PCTn for grain sorghum, average %CT for apple and cotton, and assumed 100% CT for sugarcane. The chronic analysis also incorporated average field trial residues for some commodities (pome fruit, sugarcane, bushberries, Brassica leafy greens, stone fruit , bell pepper, non - bell pepper, cucumber, summer squash, cantaloupe, strawberry , succulent snap bean, dry bean seed, and Swiss chard); average greenhouse trial residue s for tomatoes; empirical processing factors for apple juice (translated to pear and stone fruit juice ) and tomato paste and purée; and DEEM  ( ver. 7.81) default processing factors for the remaining processed commodities. The chronic dietary

(food and drinking water) exposure to novaluron is below HED’s level of concern for the general U.S. population and all pop ulation subgroups. The chronic dietary exposure results in a risk estimate that is 11 % of the chronic population - adjusted dose (cPAD) for the general U.S. population and 32 % of the cPAD for children 1 - 2 years old, the most highly exposed population subgro up. Cancer Dietary

(Food and Drinking Water) Exposure Results and Characterization A cancer dietary

assessment was not conducted because novaluron is classified as “not likely to be carcinogenic to humans.”Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

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### I. Introduction Dietary risk assessment in corporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects ). This dose is referred to as the population - adjusted dose ( PAD ) . The PAD is equivalent to the point of departure (POD ; NOAEL, LOAEL, e.g.) divided by the required uncertainty

or safety factors. For acute and non - cancer chronic exposures, HED is conc erned when estimated dietary risk exceeds 100% of the PAD. HED is generally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticide s web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21 - JUN - 2000, web link: http://www.epa.gov/fedrgstr/EPA PEST/2000/July

/Day- 12/6061.pd f

; or see SOP 99.6 (20 - AUG - 1999). The most recent dietary

risk assessment for novaluron was conducted by J. Van Alstine ( 04 - DEC - 2009 , D P# 364235 ). II. Food Residue Information Novaluron Use : Novaluron tolerances are published in 40 CFR§180.598. Res idues of Concern: The residue of concern in crops and livestock , for purposes of tolerance enforcement and risk assessment , is novaluron only . The residues of concern in drinking water for purposes of risk assessment are novaluron, the chlorophenyl urea degradate (1 - [3 - chloro - 4 - (1,1,2 - trifluoro - 2 - trifluoromethoxyethoxy )phenyl]urea), and the chloroaniline metabolite (3 - chloro - 4 - (1,1,2 - trifluoro - 2 - trifluoromethoxyethoxy )aniline) ( Memo, G. Kramer et al. , 03 - FEB 04; DP#297646 ) . Residue Data used for Chronic Assessments: Recommended Tolerances : Based on the residue chemistry data submitted with the current petition, HED recommended for establishment of the following tolerance s for residues of the insecticide novaluron , including its metabolites and degradat es, in or on the commodities listed below (Memo, J. L. Van Alstine , 23 - FEB - 2010 ; D P# 374420 ) : Grain, aspirated fractions 25 ppm Poultry, fat 7.0 ppm Sorghum, grain, grain 3.0 ppm Egg 1.5 ppm Sorghum, grain, forage 6.0 ppm Hog, meat 0.07 ppm Sor ghum, grain, stover 40 ppm Hog, liver 0.10 ppm Poultry, meat 0.40 ppm Hog, kidney 0.10 ppm Poultry, liver 0.80 ppm Hog, meat byproducts 0.10 ppm Poultry, kidney 0.80 ppm Hog, fat 1.5 ppm Poultry, meat byproducts 0.80 ppmNovaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

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### Residues used in the Chronic Analysis : The current chronic dietary analysis incorporated average %CT data for apples, cabbage, cotton, pears, and potatoes; PCTn for grain sorghum; and assumed 100% CT for the remaining commodities. The chronic dietary analysis was refine d through the use of some average field trial residues (pome fruit, sugarcane, bushberries, Brassica leafy greens, stone fruit, bell pepper, non - bell pepper, cucumber, summer squash, cantaloupe, strawberry , succulent snap bean, dry bean seed, and Swiss chard), average greenhouse trial residues for tomatoes, and calculated ARs for meat, milk, hog, and poultry commodities . Empirical processing factors for apple juice (translated to pear and stone fruit juice) and tomato paste and purée were utilized along wi th DEEM  (ver. 7.81) default processing factors for the remaining processed commodities . Inaccordance with HED Standard Operating Procedure (SOP) 2000.1, average field trial residues were translated from representative commodities in the crop group to other commodities in that crop group as needed (see Appendix 1). Attachment 1 summarizes the ARs , processing factors , average field trial residues , and %CT data which were incorporated into the current analysis . A summary of the %CT and PCTn estimates provided by

BEAD are presented in Attachments 4 and 5 . Calculation of ARs in Meat, Milk, Poultry, and Eggs Residue Chemistry Memo, DP# 285474 , 3/22/1004 , G.F. Kramer (PP# 2F6430 ) Residue Chemistry Memo, DP# 315890 , 5/10/2005 , G.F. Kramer (PP# 2F6430 ) Residue Chemistry Memo, DP# 336897, 1/31/2008, S . J. Levy ( PP#2F06430) 

### The potential for secondary transfer of novaluron residues of concern in meat, milk, and eggs exists because there are livestock feedstuffs associated with the proposed /registered novaluron uses . The livestock dietary burdens of novaluron are presented in Table 1 and are based on the proposed /registered uses, tolerance - level residues , and %CT and PCTn d ata from BEAD. The r easonably

balanced dietary burdens (RBDBs) reflect the most recent guidance from HED ( OPPTS 860.1000 Supplement, Table 1 Feedstuffs , 30 - JUN - 20 08) concerning revisions of feedstuff percentages and constructing RBDBs . Table 1 . Calculation of Dietary Burdens of Novaluron Residues to Livestock 1 . Feedstuff Ty pe 2 % Dry Matte r 3 %

Diet 3 HED Recommended

Tolerance (ppm) Average

% Crop Treated Dietary

Contribution (ppm) 4 Beef Cattle Sorghum, grain, stover R 88 15 40.0 5 5 0.34 Sorghum, grain, grain CC 86 35 3.0 5 5 0.061 Sugarcane, molasses CC 75 5 0.5 100 6 0.033 Grains, aspirat ed fractions CC 85 5 25 5 5,7 0.074 Untreated CC -- 35 -- -- -- Cottonseed, meal PC 89 5 0.60 2.5 8 0.00084 TOTAL BURDEN -- -- 100 -- -- 0.51 Dairy Cattle 9Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 5 of 26 Table 1 . Calculation of Dietary Burdens of Novaluron Residues to Livestock 1 . Feedstuff Ty pe 2 % Dry Matte r 3 %

Diet 3 HED Recommended

Tolerance (ppm) Average

% Crop Treated Dietary

Contribution (ppm) 4 Sorghum, grain, forage R 35 40 6.0 5 5 0.34 Sorghum, grain, stover R 88 5 40.0 5 5 0.11 Sorghum, grain, grain CC 86 35 3.0 5 5 0.061 Apple, wet pomace CC 40 10 8.0 15 8 0.30 Cotton, undelinted seed PC 88 10 0.60 2.5 8 0.0017 TOTAL BURDEN -- -- 100 -- -- 0.81 Poultry Sorghum, grain, grain CC 86 75 3.0 5 5 0.11 Cottonseed, meal PC 89 20 0.60 2.5 8 0.003 Untreated PC -- 5 -- -- -- TOTAL BURDEN -- -- 100 -- -- 0.11 Swine Sorghum, grain, grain CC 86 80 3.0 5 5 0.12 Untreated CC -- 5 -- -- -- Cottonseed, meal PC 89 15 0.60 2.5 8 0.0022 TOTAL BURDEN -- -- 100 -- -- 0.12 1 Original t able (without %CT and PCTn) prepared by Jerry Stokes; 29 - OCT - 2009. 2 R: roughage; CC: carbohydrate concentrate; PC: protein concentrate. 3 OPPTS 860.1000 Table 1 Feedstuffs (June 2008). 4 Contribution = ([tolerance /% DM] X % diet X %CT ) for beef and dairy cattle ; contribution = ([tolerance] X % diet X %CT ) for poultry and swine. 5 PCTn from BEAD memo ( C . Doucoure et al. , 29 - DEC - 09; D37161 5 ). 6 No %CT data was available for s ugarcane , so 100% crop treated was assumed. 7 Sorghum is currently the only source of nova luron r esidues for AGF. This value may change if tolerances are established for other grain commodities which may be processed into AGF. 8 Average %CT from SLUA memo (A. Grube, 17 - NOV - 09; D371221). 9 P etition 8E7425 (Memo, J. Van Alstine, 09 - SEP - 2009 ; D 357060 ) included a request for the use of novaluron on turnip greens ; HED requested that the petitioner submit a new label which prohibits the use of novaluron on turnips harvested for the root and prohibits the feeding of turnip tops to livestock. 

### Expe cted secondary

residues in meat and milk T he anticipated secondary residues in cattle matrices were estimated using average transfer coefficients calculated from the maximum residues of novaluron observed at the 3.9 - , 12.6 - , and 42.8 - ppm dose levels ( PP#2 F6430 ). The transfer coefficients (calculated as residue - level - to - feed ratios) are presented in Table 2 . The transfer coefficient for each matrix was then used to calculate the expected secondary residues by

multiplying the average transfer coefficient b y the calculated dietary

burden (Tables 3 and 4 ). Table 2 . Residue - Level - to - Feed Ratios (Transfer Coefficients) in Dairy Cattle Milk and Tissues. Matrix Maximum Residues (ppm) Feeding Levels (ppm) Transfer Coefficients (Average) Whole milk 0.17, 0.43 , 2.07 3.9, 12.6, 42.8 0.044, 0.034, 0.048, (0.042) Muscle 0.09, 0.34, 0.56 0.023, 0.027, 0.013, (0.021) Kidney 0.14, 0.35, 1.20 0.036, 0.028, 0.028, (0.031) Liver 0.14, 0.41, 1.36 0.036, 0.033, 0.032, (0.034 ) Fat (peritoneal) 2.25, 6.83, 12.89 0. 577, 0.542, 0.301, (0.473)Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 6 of 26 Table 3 . Expected Secondary Residues in Cattle Meat and Milk. Matrix Dietary burden (ppm) Anticipated Secondary Residues (ppm) 1 Whole milk 0.81 0.034 Muscle 0.017 Kidney 0.025 Liver 0.027 Fat (peritoneal) 0. 39 1 C alculated from dietary burden x average transfer coefficient from Table 2 (using non - truncated values) . Table 4 . Expected Secondary Residues in Hog Meat. Matrix Dietary burden (ppm) Anticipated Secondary Residues (ppm) 1 Muscle 0.12 0.0026 Kidney 0. 0037 Liver 0.0041 Fat (peritoneal) 0.058 1 Calculated from dietary burden x average transfer coefficient from Table 2 (using non - truncated values) . 2 In 40 CFR §180.598 , the tolerance is for hog, meat byproducts. 

### Expected secondary

residues in po ultry

meat and eggs T he anticipated secondary residues in poultry

matrices were estimated using average transfer coefficients calculated from the maximum residues of novaluron observed in the hen metabolism study (0.12 - , 0.36 - , 1.2 - ppm dose levels; PP#2F0 6430). The transfer coefficients (calculated as residue - level - to - feed ratios) are presented in Table 5 . The transfer coefficient for each matrix was then used to calculate the expected secondary residues by

multiplying the average transfer coefficient by the calculated dietary burden (Table 6 ). Table 5 . Residue - Level - to - Feed Ratios (Transfer Coefficients) in Poultry Eggs and Tissues. Matrix Maximum

Residues (ppm) Feeding Levels (ppm) Transfer Coefficients (Average) Eggs (day 54) 0.063, 0.181, 0.702 0.12, 0.36, 1.2 0.53, 0.50, 0.59, (0.54) Muscle 0.014, 0.031, 0.160 0.12, 0.09, 0.13, (0.11) Liver 0.034, 0.096, 0.364 0.28, 0.27, 0.30, (0.28) Kidney 0.039, 0.089, 0.368 0.33, 0.25, 0.31, (0.29) Fat (abdominal) 0.323, 0.988, 3.011 2.7, 2.7, 2.5, ( 2.6) Table 6 . Expected Secondary Residues in Poultry Meat and Eggs . Matrix Dietary burden (ppm) Anticipated Secondary Residues (ppm) 1 Eggs (day 54) 0.11 0.062 Muscle 0.01 3 Liver 0.033 2 Kidney 0.034 2 Fat (abdominal) 0. 31 1 Calculated from diet ary burden x average transfer coefficient from Table 5 (using non - truncated values) . 2 In 40 CFR §180.598 , the tolerance is for hog, meat byproducts.Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

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### III. Drinking Water Data The drinking water residues used in the dietary risk assessment were provide d by EFED in the following memorandum: “Novaluron and Novaluron Degradates (Chlorophenyl urea and Chloroaniline) Drinking Water Assessment in Support of New Use Registration Action for So rghum, Fruiting Vegetables (Gro u p 8, D364309), Cucurbit Vegetables ( Group 9), L ow growing Berry

Subgroup (13 - 07G), Snap and Dry Bean, and Swiss Chard ” (I . Maher, 16 - JUL - 0 9; D P# 363989 ) 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, in direct, all sources.” Since the application rates are significantly lower for the proposed uses than for pome fruits and stone fruits, the estimated drinking water concentrations provided in the previous drinking water assessments dated 10 - MAR - 2009 (D P# 357061) and 11 - FEB - 2004 (D P# 285477) are applicable for the proposed uses. Monitoring data are not available for novaluron or its chlorophenyl urea and chloroaniline degradates . Concentrations in surface water and groun d water were estimated using modeling. Novaluron: EFED used Tier 2 Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) modeling to estimate drinking water concentrations for surface water for novaluron per se . The EDWC (1 - in - 10 - ye ar annual mean) for novaluron only is 0.76 ppb in surface water . For groundwater, the Screening Concentration in Ground Water (SCI - GROW) model was used to predict a groundwater concentration for novaluron. The EDWC for novaluron only is 0.00 5 6 ppb in dri nking water from shallow ground water sources. Chlorophenyl urea and chloroaniline degradates: A Tier 1 drinking water analysis was performed using the FQPA Index Reservoir Screening Tool (FIRST) model to obtain surface water estimates for the chlorophenylurea and chloroaniline degradates. For surface water, the annual average EDWC for the chlorophenyl urea degradate is ≤ 0.89 ppb and the annual average EDWC for the chloroaniline degradate is ≤ 2.6 ppb. T he SCI - GROW model was used to predict groundwater concentrations. The predicted groundwater EDWC for the chlorophenyl urea degradate is < 0.00 45 ppb , and for the chloroani line degradate, the EDWC is < 0.00 90 ppb . These EDWC values are meant to represent upper - bound estimates of the concentrations that might be found in surface water and groundwater based upon existing and proposed uses. Of the three EDWC values, the chroni c estimate for the terminal degradate , chloroaniline , is the highest (100% conversion from parent to the chloroaniline degradate was assumed). This is consistent with the expected degradation of novaluron. Therefore, the EDWC value for chloroaniline (2.6 ppb) was used to assess chronic aggregate risk for this dietary assessment . IV . Percent Crop Treated A SLUA memorandum entitled, “Usage Report Package in Support of Registration for the In secticide Novaluron (124002), BEAN DP# 371221” (A. Grube, 17 -NO V - 2009) and a PCTn memorandum entitled, “Percent Crop Treated for New Use (PCTn): Novaluron (124002) Use on Sorghum, DP# 371615” (C. Doucoure et al. , 29 - DEC - 2009) were provided by BEAD. TheNovaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

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### SLUA memo included %CT data for apples, cabbage, cotton, pears, a nd potatoes. The market leader approach was used by BEAD to determine the PCTn for sorghum. The chronic dietary

analysis incorporated average %CT data for apples (15%), cabbage (10%), cotton (2.5%), pears (10%), and potatoes (2.5%) and PCTn data for grain sorghum (5%). 100% CT was assumed for the remaining food commodities. L i vestock dietary burdens of novaluron were calculated based on the proposed/registered uses, tolerance - level residues , and PCTn data for grain sorghum (5%), average %CT data for a pple (15%) and cotton (2.5%), and 100% CT for sugarcane. These livestock dietary burdens were used, along with average transfer coefficients, to calculate anticipated secondary residues for meat, milk, hog, and poultry commodities which were incorporated into the chronic dietary assessment. Attachment 1 summarizes the % CT data utilized in the chronic dietary assessment . Please refer to Attachments 4 and 5 for the %CT and PCTn memorandums provided by BEAD . V. DEEM - FCIDTM Program and Consumption Information A novaluron chronic dietary exposure assessment was conducted using DEEM - FCIDTM, Version 2.03 which incorporates consumption data from USDA’s CSFII, 1994 - 1996 and 1998. The 1994 - 96 and 1998 data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA defined food commodities (e.g. , apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour

- coo ked; 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, but for acute exposure assessment are retained as individual consumption events. Based on analysis of the 1994 - 96 and 1998 CSFI I consumption data, which took into account dietary patterns and survey

respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ years old. For chronic dietary

exposure assessment, an est imate of the residue level in each food or food form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily

consumption estimate for that food/food form to prod uce a residue intake estimate. The resulting resi due intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg body weight/day

and as a percent of the cPAD. This procedure is performed for each population subgroup. VI . Toxicological Information The RAB1 toxicologists have reevaluated the novaluron database and reaffirmed the previous conclusion of the Hazard I dentification Assessment Re view Committee (HIARC; 16 - DEC - 2003, TXR# 0052361) that the Food Quality Protection Act (FQPA) Safety Factor (SF) for increased susceptibility

of infants and children can be reduced to 1X. The decision was based on a lack ofNovaluron Dietary Exposure & Risk Assessment DP#: D374419

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### increased susceptibility

in the rat and/or rabbit developmental toxicity studies at levels up to the limit dose. Also, no increased qualitative and/or quantitative evidence of increased susceptibility was found following pre/post - natal exposure in a two - generation reproduction study in rats. The risk assessment team has concluded that the FQPA SF for increased susceptibility of infants and children can be reduced to 1X based on toxicological considerations (above), the conservative residue assumptions used for dietary risk assessments, the completeness of the residue chemistry database, and conservative drinking water assessment. Table 7 is a summary of the decisions made by the HIARC concerning dietary exposure assessment . These endpoints have been confirmed by

the risk assessment te am as appropriate for the current risk assessment . Table 7 . Sum ma ry of Toxicological Doses and Endpoints for Novaluron for Use in Dietary Exposure Risk

Assessments . Exposure/ Scenario Point of

Departure Uncertainty/FQPA

Safety Factors RfD, PAD, Level of Concern Study and Toxicological

Effects Acute Dietary (All Populations) N/A N/A N/A An endpoint of concern attributable to a single dose was not identified. An acute RfD was not established. Chronic Dietary (All Populations) NOAEL =

1.1 mg/kg/day U F A = 10 X

UF H = 10 X FQPA SF = 1 X Chronic RfD = 0.011 mg/kg/day cPAD = 0.011 mg/kg/day Combined chronic

toxicity/carcinogenicity feeding in rat. LOAEL = 30.6 mg/kg/day based on erythrocyte damage and turnover resulting in a regenerative anemia. Cancer (o ral, dermal, inhalation) Classification: “Not likely to be Carcinogenic to Humans.” 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 dete rmine 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. N/A = not applicable. 

### V II . Results/Discussion As stated above, for a chronic assessment, HED is concerned when dietary risk exceeds 100% of the cPAD. The chronic analysis was performed using DEEM - FCID  (ver. 2.03). The DEEM FCID  analysis estimates the dietary exposure of the U.S. population and various p opulation subgroups. The results reported in Table 8 are for the general U.S. population, all infants (<1 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, adults 50+ years old , and females 13 - 49 ye ars old . The resulting fo od and drinking water exposure estimates were not of concern to HED (  100% cPAD) . The chronic dietary exposure estimates are 11 % of the cPAD for the general U.S. population and 32 % of the cPAD for children 1 - 2 years old, the most highly exposed population subgroup (see Attachment 3 for details).Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 10 of 26 Table 8 . Sum ma ry of Chronic Dietary Exposure (Food and Drinking Water) and Risk for Novaluron. Population Subgroup Acute Dietary Chronic Dietary Cancer Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD Dietary Exposure (mg/kg/day) Risk General U.S. Population
N/A N/A 0.001206 11
N/A N/A All Infants (< 1 year old) 0.001955 18 Children 1 - 2 years old 0.003537 32 Children 3 - 5 years old 0.002771 25 Children 6 - 12 years old 0. 001700 16 Youth 13 - 19 years old 0.001021 9 Adults 20 - 49 years old 0.000884 8 Adults 50+ years old 0.001027 9 Females 13 - 49 years old 0.000874 8 

### VI II . Characterization of Inputs/Outputs The chronic dietary

assessment was refined through the use of some average field trial residues (pome fruit, sugarcane, bushberries, Brassica leafy greens, stone fruit, bell pepper, non - bell pepper, cucumber, summer squash, cantaloupe, strawberry , succulent snap bean, dry bean seed, and Swiss chard), average greenhouse trial residues for tomatoes, and ARs for meat, milk, hog, and poultry commodities . Empirical processing factors for apple juice (translated to pear and stone fruit juice) and tomato paste and purée were utilized along with DEEM  (ver. 7 .81) default processing factors for the remaining processed commodities . Inaccordance with HED SOP 2000.1, average field trial residues were translated from representative commodities in the crop group to other commodities in that crop group as needed ( s ee Appendix 1). Despite this, HED concludes that the chronic estimates are still highly conservative since they

assumed average residues based on field trial data [maximum application rate; minimum pre - harvest interval (PHI); frozen immediately after harv est]. The current chronic dietary analysis also incorporated average % CT data for apples, cabbage, cotton, pears, and potatoes and average PCTn for sorghum. 100% CT was assumed for the remaining comm odities. ARs for meat, milk, hog, and poultry

commodit ies were calculated using PCTn for sorghum, average %CT for apple and cotton, and 100% CT for sugarcane. The current chronic analysis could be further refined through the use of monitoring data and preparation/cooking factors . IX . Conclusions A chroni c dietary

risk assessment was conducted using DEEM - FCID  (ver. 2.03) . Updated ARs for meat, milk, hog, and poultry commodities were incorporated into the chronic dietary risk assessment along w ith %CT data provided by BEAD. EDWC values, provided by EFED, were included in this dietary

assessment. The chronic dietary (food and drinking water) exposure to novaluron is below HED’s level of concern for the general U.S. population and all population subgroups. The chronic dietary exposure estimates are 11 % of the cPAD for the general U.S. population and 32 % of the cPAD for children 1 - 2 years old, the most highly exposed population subgroup.Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

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### X . List of Attachments Attachment 1: Processing Factor, AR, and Average Field Trial Residue Table. Attachment 2: DEEM - FCID  Chronic Residue Input File . Attachment 3: DEEM - FCID  Chronic Results File. Attachment 4: Usage Report Package in Support of Registration for the Insecticide Novaluron

(124002), BEAN DP# 371221 ( Memo, A. Grube , 17 -NOV - 2009 ) . Attachment 5: Percent Cro p Treated for New Use (PCTn): Novaluron (124002) Use on

Sorghum, DP# 371615 (Memo, C. Doucoure et al. , 29 - DEC - 2009) .

cc: Julie L. Van Alstine J .L . Van Alstine :S - 10954:PY - S:(703)603 - 8866:7509P:RAB1Novaluron Dietary Exposure & Risk Assessment DP#: D374419 PC Code: 124002

Page 12 of 26 Attachm ent 1: Processing Facto rs and Residue Estim ates fromPrevious Novaluron Dietary Assessm ents 1 Updated to Include Current ARs for Meat, Milk, Hog, and Poultry Com mo dities and % CT . C rop C ommodity P rocessing F actor R esidue

(ppm) 1 Average

%CT C omment meat2 meat 1 0. 017 100% AR drie d beef meat dried meat 1.92 0. 017 100% AR; DEEM (ver. 7.78) default proc. fact. fat2 (peritoneal) fat 1 0.39 100% AR liver2 liver 1 0 .027 100% AR kidney

2 kidney 1 0.025 100% AR meat byproducts except liver and kidney 2 meat byproducts 1 0 .027 100% AR (meat liver) milk Milk, fat 1 0.85 100% AR, calculated assuming residues partition into fat [w hole milk secondary residue x 25 (maximum concentration factor for milk fat)] Milk, nonfat solids 1 0.034 100% AR for whole milk, used to account for low residue s observed in skim milk Milk, water 1 0 100% All residues assumed to be associated with fat and solids Milk, sugar 1 0 100% All residues assumed to be associated with fat and solids pork meat meat 1 0.0026 100% AR pork skin skin 1 0.058 100% AR (pork peritoneal fat) pork fat (peritoneal) fat 1 0.058 100% AR pork liver liver 1 0.0041 100% AR pork kidney kidney 1 0.0037 100% AR pork meat byproducts meat byproducts 1 0.0041 100% AR (pork liver) poultry meat meat 1 0.013 100% AR poultry liver liver 1 0.033 100% AR poultry kidney kidney 1 0.034 100% AR poultry meat byproducts meat byproducts 1 0.034 100% AR (poultry kidney) poultry fat (abdominal) fat 1 0.31 100% AR poultry skin skin 1 0.31 100% AR (poultry abdominal fat) egg RAC 1 0.062 100% AR cotton cottonseed oil 1 0.60 <2.5% t olerance for RAC adequate to cover residues in processed commodity ; average % CT for cotton from SLUA memo (A. Grube, 17 - NOV - 09; D371221) tuberous and corm vegetables All 1 0.025 <2.5% 1⁄2 LOQ residue; DEEM (ver. 7.78) de fault proc. factor of 6.5 used for potato, dry ; average % CT assumed for potato only ( SLUA ; A. Grube, 17 - NOV - 09; D371221) pome fruit

– apple, crabapple 3 RAC, sauce 1 0.578 15% average field trial residue ; average % CT assumed for apple only ( SLUA ; A. Grube, 17 - NOV - 09; D371221) dried 8 0.578 15% average field trial residue; DEEM (ver. 7.78) default proc. fact. ; average % CT assumed for apple only ( SLUA ; A. Grube, 17 - NOV - 09; D371221) juice 0.10 0.578 15% average field trial residue; empirical proc. fact. ; average % CT assumed for apple only ( SLUA ; A. Grube, 17 - NOV - 09; D371221) pome fruit

– pear + other pome fruit 3 RAC 1 0.833 10% average field trial residue ; average % CT assumed for pear only ( SLUA ; A. Grube, 17 - NOV - 09; D371221)Novaluron Dietary Exposure & Risk Assessment DP#: D374419 PC Code: 124002

Page 13 of 26 C rop C ommodity P rocessing F actor R esidue

(ppm) 1 Average

%CT C omment dried 6.25 0.833 10% average field trial residue; DEEM (ver. 7.78) default proc. fact. ; average % CT assumed for pear only ( SLUA ; A. Grube, 17 - NOV - 09; D371221) juice 0.10 0.833 10% average field trial residue; empirical apple proc. fact. ; average % CT assumed for pear only ( SLUA ; A. Grube, 17 - NOV - 09; D371221) s ugarcane sugar 1 0.125 100% average field trial residue molasses 1 0.125 100% average field trial residue t omato , tomatillo, tree tomato 4 RAC 1 0.161 100% overall (small - & large - fruit varieties) average of the greenhouse trial residue. dried 14.3 0.161 100% overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. fact. juice 1.5 0.161 100% overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. fact. purée 0.7 0.161 100% o verall average of the greenhouse trial residue; empirical proc. fact. paste 1.1 0.161 100% overall average of the greenhouse trial residue; empirical proc. fact. bell pepper, eggplant 5 RAC 1 0.14 100% average bell pepper field trial residue non - bell pepper, okra 6 RAC 1 0.16 100% average non - bell pepper field trial residue Brassica , l eafy greens, s ubgroup 5B and turnip, greens All 1 5.33 100% average mustard green field trial residue plum RAC 1 0.403 100% average plum field trial residue dried 1 2.6 100% tolerance for dried plum juice 0.10 0.403 100% average plum field trial residue; empirical apple proc. fact. cherry RAC 1 2.17 100% average field trial residue juice 0.10 2.17 100% average field trial residue ; empirical apple proc. fact. peach, nectarine, and apricot 7 RAC 1 0.61 100% average peach field trial residue dried (peach) 7.0 0.61 100% average peach field trial residue; DEEM (ver. 7.78) default proc. fact. of 7.0 used for peaches, dried and 6.0 used for apricots, dried dried (aprico t) 6.0 juice 0.10 0.61 100% average peach field trial residue; empirical apple proc. fact. cucumber, Chinese waxgourd, balsam pear 8 All 1 0.05 100% average cucumber field trial residue cantaloupe, casaba, honeydew melon, winter melon, watermelon 9 RA C 1 0.055 100% average cantaloupe field trial residue juice 1 0.055 100% average cantaloupe field trial residue summer squash, chayote fruit Christophe, pumpkin, winter squash 10 All 1 0.044 100% average summer squash field trial residue bushberry s ubgr oup 13 - 07B 11 All 1 1.97 100% average blueberry field trial residue low growing berry subgroup 13 - 07G (except lowbush blueberry) 12 All 1 0.140 100% average strawberry field trial residue; DEEM (ver. 7.78) default proc. fact. of 1.1 used for cranberry juice snap bean (succulent) All 1 0.18 100% average succulent snap bean pods with seeds field trial residue dry bean seed All 1 0.065 100% average dry bean seed field trial residue Swiss chard All 1 4.2 100% average Swiss chard field trial residue Brassica , head and steam, subgroup 5A All 1 0.50 10% tolerance level residue; average % CT assumed for cabbage only ( SLUA ; A. Grube, 17 - NOV - 09; D371221)Novaluron Dietary Exposure & Risk Assessment DP#: D374419 PC Code: 124002

Page 14 of 26 C rop C ommodity P rocessing F actor R esidue

(ppm) 1 Average

%CT C omment Sorghum, grain grain 1 3.0 5% tolerance level residue; average %CT assumed for grain only ( PCTn memo; C. Doucour e et al. , 29 - DEC - 2009, D371615 1 Memo, G. Kramer, 22 - MAR - 2004 DP#285474 ; Memo, G. Kramer, 22 - MAR - 2004, DP#298783; Memo, G. Kramer , 07 - FEB - 2008, DP#347657 ; Memo, J. Van Alstine, 09 - SEP - 2009, DP#359460; Memo, J. Van Alstine, 04 - DEC - 2009, DP#364235 . 2 Cattl e, goat, horse, and sheep. 3 Apple and pear residues were translated to the remaining pome fruit crops using HED SOP 2000.1. 4 Tomato residues were translated to tomatillo and tree tomato using HED SOP 2000.1. 5 Bell pepper residues were translated to eggp lant using HED SOP 2000.1. 6 Non - bell pepper residues were translated to okra. 7 Peach residues were translated to nectarine and apricot crops using HED SOP 2000.1. 8 Cucumber residues were translated to Chinese waxgourd and balsam pear using HED SOP 2000. 1. 9 Cantaloupe residues were translated to casabas, honeydew melon, winter melon, and watermelon using HED SOP 2000.1. 10 Summer squash residues were translated to chayote fruit Christophe, pumpkin, and winter squash using HED SOP 2000.1. 11 Blueberry res idues were translated to currant, elderberry, gooseberry, and huckleberry using the memo titled “ChemSAC Review of USDA IR- 4 Crop Grouping Proposal to Amend the Berry Crop Group 13” (B. Schneider, 28 - MAR - 2006). 12 Strawberry residues were translated to cra nberry using the memo titled “ChemSAC Review of USDA IR- 4 Crop Grouping Proposal to Amend the Berry Crop Group 13” (B. Schneider, 28 - MAR - 2006).Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 15 of 26



### Attachment 2: DEEM - FCID  Chronic Residue Input File Filename: C: \ Documents and Settings \ jlangsda \ My Documen ts \ Chemicals \ Novaluron \ Sorghum \ DEEM \ Sent to Reviewers \ 124002 - chronic - 2009 - JLV__04 - FEB - 10.R98 Chemical: Novaluron RfD(Chronic): .011 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modif ied: 02 - 05 - 2010/07:35:49/8 Program ver. 2.03

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 01030150 1CD Arrowroot, flour 0.025000 1.000 1.000 01030151 1CD Arrowroot, flour - babyfood 0.025000 1.000 1.000 01030170 1CD Artichoke, Jerusalem 0.025000 1.000 1.000 01030820 1CD Cassava 0.025000 1.000 1.000 01030821 1CD Cassava - babyfood 0.025000 1.000 1.000 01031390 1CD Dasheen , corm 0.025000 1.000 1.000 01031660 1CD Ginger 0.025000 1.000 1.000 01031661 1CD Ginger - babyfood 0.025000 1.000 1.000 01031670 1CD Ginger, dried 0.0 25000 1.000 1.000 01032960 1C Potato, chips 0.025000 1.000 0.025 01032970 1C Potato, dry (granules/ flakes) 0.025000 6.500 0.025 01032971 1C Potato, dry (granules/ flakes) - b 0.025000 6.500 0.025 01032980 1C Potato, flour 0.025000 6.500 0.025 01032981 1C Potato, flour - babyfood 0.025000 6.500 0.025 01032990 1C Potato, tuber, w/peel 0.025000 1.000 0.025 01032991 1C Potato, tuber, w/peel - bab yfood 0.025000 1.000 0.025 01033000 1C Potato, tuber, w/o peel 0.025000 1.000 0.025 01033001 1C Potato, tuber, w/o peel - babyfood 0.025000 1.000 0.025 01033660 1CD Sweet potato 0.025000 1.000 1.0 00 01033661 1CD Sweet potato - babyfood 0.025000 1.000 1.000 01033710 1CD Tanier, corm 0.025000 1.000 1.000 01033870 1CD Turmeric 0.025000 1.000 1.000 01034060 1CD Yam, true 0.025000 1.000 1.000 01034070 1CD Yam bean 0.025000 1.000 1.000 04023670 4B Swiss chard 4.200000 1.000 1.000 05010610 5A Broccoli 0.500000 1.000 1.000 05010611 5A Broccoli - babyfood 0.500000 1.000 1.000 05010620 5A Broccoli, Chinese 0.500000 1.000 1.000 05010640 5A Brussels sprouts 0.500000 1.000 1.000 05010690 5A Cabbage 0.500000 1.000 0.100 05010710 5A Cabbage, Chinese, napa 0.500000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 0.500000 1.000 1.000 05010830 5A Cauliflower 0.500000 1.000 1.000 05011960 5A Kohlrabi 0.500000 1.000 1.000 05020630 5B Broccoli raab 5.330000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 5.330000 1.000 1.000 05021170 5B Collards 5.330000 1.000 1.000 05021940 5B Kale 5.330000 1.000 1.000 05022290 5B Mustard greens 5.330000 1.000 1.000 05023180 5B Rape greens 5.330000 1.000 1.000 05023890 5B Turnip, greens 5.330000 1.000 1.000 06010430 6A Bean, snap, succulent 0.180000 1.000 1.000 06010431 6A Bean, snap, succulent - babyfood 0.180000 1. 000 1.000 06030300 6C Bean, black, seed 0.065000 1.000 1.000 06030320 6C Bean, broad, seed 0.065000 1.000 1.000 06030340 6C Bean, cowpea, seed 0.065000 1.000 1.000 06030350 6C Bean , great northern, seed 0.065000 1.000 1.000 06030360 6C Bean, kidney, seed 0.065000 1.000 1.000 06030380 6C Bean, lima, seed 0.065000 1.000 1.000 06030390 6C Bean, mung, seed 0.065000 1.000 1.000 06030400 6C Bean, navy, seed 0.065000 1.000 1.000 06030410 6C Bean, pink, seed 0.065000 1.000 1.000 06030420 6C Bean, pinto, seed 0.065000 1.000 1.000 06030 980 6C Chickpea, seed 0.065000 1.000 1.000 06030981 6C Chickpea, seed - babyfood 0.065000 1.000 1.000 06030990 6C Chickpea, flour 0.065000 1.000 1.000 06031820 6C Guar, seed 0.065000 1.000 1.000 06031821 6C Guar, seed - babyfood 0.065000 1.000 1.000 06032030 6C Lentil, seed 0.065000 1.000 1.000 06032560 6C Pea, dry 0.065000 1.000 1.000 06032561 6C Pea, dry - babyfood 0.065000 1.000 1.000Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 16 of 26 06032580 6C Pea, pigeon, seed 0.065000 1.000 1.000 08001480 8 Eggplant 0.140000 1.000 1.000 08002340 8 Okra 0.160000 1.000 1.000 08002700 8 Pepper, bell 0.140000 1.000 1.000 08002701 8 Pepper, bell - babyfood 0.140000 1.000 1.000 08002710 8 Pepper, bell, dried 0.140 000 1.000 1.000 08002711 8 Pepper, bell, dried - babyfood 0.140000 1.000 1.000 08002720 8 Pepper, nonbell 0.160000 1.000 1.000 08002721 8 Pepper, nonbell - babyfood 0.160000 1.000 1.000 08002730 8 Pepper, nonbell, dried 0.160000 1.000 1.000 08003740 8 Tomatillo 0.161000 1.000 1.000 08003750 8 Tomato 0.161000 1.000 1.000 08003751 8 Tomato - babyfood 0.161000 1.000 1.000 08003760 8 Tomato, paste 0.161000 1.100 1.000 08003761 8 Tomato, paste - babyfood 0.161000 1.100 1.000 08003770 8 Tomato, puree 0.161000 0.700 1.000 08003771 8 Tomato, puree - babyfood 0.161000 0.700 1.000 08003780 8 Tomato, dried 0.161000 14.300 1.000 08003781 8 Tomato, dried - babyfood 0.161000 14.300 1.000 08003790 8 Tomato, juice 0.161000 1.500 1.000 09010750 9A Cantaloupe 0.055000 1.000 1.000 09010800 9A Casaba 0.055000 1.000 1.000 09011870 9A Honeydew melon 0.055000 1.000 1.000 09013990 9A Watermelon 0.055000 1.000 1.000 09014000 9A Watermelon, juice 0.055000 1.000 1.000 09020210 9B Balsam pear 0.050000 1.000 1.000 09020880 9B C hayote, fruit 0.044000 1.000 1.000 09021020 9B Chinese waxgourd 0.050000 1.000 1.000 09021350 9B Cucumber 0.050000 1.000 1.000 09023080 9B Pumpkin 0.044000 1.000 1.000 09023090 9B Pumpkin, seed 0.044000 1.000 1.000 09023560 9B Squash, summer 0.044000 1.000 1.000 09023561 9B Squash, summer - babyfood 0.044000 1.000 1.000 09 023570 9B Squash, winter 0.044000 1.000 1.000 09023571 9B Squash, winter - babyfood 0.044000 1.000 1.000 11000070 11 Apple, fruit with peel 0.578000 1.000 0.150 11000080 11 Apple, peeled fruit 0.578000 1.000 0.150 11000081 11 Apple, peeled fruit - babyfood 0.578000 1.000 0.150 11000090 11 Apple, dried 0.578000 8.000 0.150 11000091 11 Apple, dried - babyfood 0.578000 8.00 0 0.150 11000100 11 Apple, juice 0.578000 0.100 0.150 11000101 11 Apple, juice - babyfood 0.578000 0.100 0.150 11000110 11 Apple, sauce 0.578000 1.000 0.150 11000111 11 Apple, sauce - babyfood 0.578000 1.000 0.150 11001290 11 Crabapple 0.578000 1.000 1.000 11002100 11 Loquat 0.833000 1.000 1.000 11002660 11 Pear 0. 833000 1.000 0.100 11002661 11 Pear - babyfood 0.833000 1.000 0.100 11002670 11 Pear, dried 0.833000 6.250 0.100 11002680 11 Pear, juice 0.833000 0.100 0.100 1100268 1 11 Pear, juice - babyfood 0.833000 0.100 0.100 11003100 11 Quince 0.833000 1.000 1.000 12000120 12 Apricot 0.610000 1.000 1.000 12000121 12 Apricot - babyfood 0.610000 1.000 1.000 12000130 12 Apricot, dried 0.610000 6.000 1.000 12000140 12 Apricot, juice 0.610000 0.100 1.000 12000141 12 Apricot, juice - babyfood 0.610000 0.100 1. 000 12000900 12 Cherry 2.170000 1.000 1.000 12000901 12 Cherry - babyfood 2.170000 1.000 1.000 12000910 12 Cherry, juice 2.170000 0.100 1.000 12000911 12 Cherry, jui ce - babyfood 2.170000 0.100 1.000 12002300 12 Nectarine 0.610000 1.000 1.000 12002600 12 Peach 0.610000 1.000 1.000 12002601 12 Peach - babyfood 0.61000 0 1.000 1.000 12002610 12 Peach, dried 0.610000 7.000 1.000 12002611 12 Peach, dried - babyfood 0.610000 7.000 1.000 12002620 12 Peach, juice 0.610000 0.100 1.000 12002621 12 Peach, juice - babyfood 0.610000 0.100 1.000 12002850 12 Plum 0.403000 1.000 1.000 12002851 12 Plum - babyfood 0.403000 1.000 1.000 12002860 12 Plum, prune, fresh 0.403000 1.000 1.000 12002861 12 Plum, prune, fresh - babyfood 0.403000 1.000 1.000 12002870 12 Plum, prune, dried 2.600000 1.000 1.000 12002871 12 Plum, prune, dried - babyfood 2.600000 1.000 1.000Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 17 of 26 12002880 12 Plum, prune, juice 0.403000 0.100 1.000 12002881 12 Plum, prune, juice - babyfood 0.403000 0.100 1.000 13020570 13B Blueberry 1.970000 1.000 1.000 13020571 13B Blueberry - babyfo od 1.970000 1.000 1.000 13021360 13B Currant 1.970000 1.000 1.000 13021370 13B Currant, dried 1.970000 1.000 1.000 13021490 13B Elderberry 1.970000 1 .000 1.000 13021740 13B Gooseberry 1.970000 1.000 1.000 13021910 13B Huckleberry 1.970000 1.000 1.000 15003440 15 Sorghum, grain 3.000000 1.000 0.050 21000440 M Bee f, meat 0.017000 1.000 1.000 21000441 M Beef, meat - babyfood 0.017000 1.000 1.000 21000450 M Beef, meat, dried 0.017000 1.920 1.000 21000460 M Beef, meat byproducts 0.027000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 0.027000 1.000 1.000 21000470 M Beef, fat 0.390000 1.000 1.000 21000471 M Beef,fat - babyfood 0.390000 1.000 1.000 2100 0480 M Beef, kidney 0.025000 1.000 1.000 21000490 M Beef, liver 0.027000 1.000 1.000 21000491 M Beef, liver - babyfood 0.027000 1.000 1.000 23001690 M Goat, meat 0.017000 1.000 1.000 23001700 M Goat, meat byproducts 0.027000 1.000 1.000 23001710 M Goat, fat 0.390000 1.000 1.000 23001720 M Goat, kidney 0.025000 1.000 1.000 23001730 M Goat, liver 0.027000 1.000 1.000 24001890 M Horse, meat 0.017000 1.000 1.000 25002900 M Pork, meat 0.002600 1.000 1.000 25002901 M Pork, me at - babyfood 0.002600 1.000 1.000 25002910 M Pork, skin 0.058000 1.000 1.000 25002920 M Pork, meat byproducts 0.004100 1.000 1.000 25002921 M Pork, meat byproducts - babyfood 0.00 4100 1.000 1.000 25002930 M Pork, fat 0.058000 1.000 1.000 25002931 M Pork, fat - babyfood 0.058000 1.000 1.000 25002940 M Pork, kidney 0.003700 1.000 1.000 25002950 M Pork, liver 0.004100 1.000 1.000 26003390 M Sheep, meat 0.017000 1.000 1.000 26003391 M Sheep, meat - babyfood 0.017000 1.000 1.000 26003400 M Sheep, meat byproducts 0.027000 1.000 1.000 26003410 M Sheep, fat 0.390000 1.000 1.000 26003411 M Sheep, fat - babyfood 0.390000 1.000 1.000 26003420 M Sheep, kidney 0.025000 1.000 1.00 0 26003430 M Sheep, liver 0.027000 1.000 1.000 27002220 D Milk, fat 0.850000 1.000 1.000 27002221 D Milk, fat - baby food/infant for 0.850000 1.000 1.000 27012230 D Milk, nonfat solids 0.034000 1.000 1.000 27012231 D Milk, nonfat solids - baby food/in 0.034000 1.000 1.000 40000930 P Chicken, meat 0.013000 1.000 1.000 40000931 P Chicken, meat - babyfood 0.013000 1.000 1.000 40000940 P Chicken, liver 0.033000 1.000 1.000 40000950 P Chicken, meat byproducts 0.034000 1.000 1.000 40000951 P Chicken, meat byproducts - babyfoo 0.034000 1.000 1.000 40000960 P Chicken, fat 0.310000 1.000 1.000 40000961 P Chicken, fat - babyfood 0.310000 1.000 1.000 40000970 P Chicken, skin 0.310000 1.000 1.000 40000971 P Chicken, skin - babyfood 0.310000 1.000 1.000 50003820 P Turkey, meat 0.013000 1.000 1.000 50003821 P Turkey, meat - babyfood 0.013000 1.000 1.000 50003830 P Turkey, liver 0.033000 1.000 1.000 5 0003831 P Turkey, liver - babyfood 0.033000 1.000 1.000 50003840 P Turkey, meat byproducts 0.034000 1.000 1.000 50003841 P Turkey, meat byproducts - babyfood 0.034000 1.000 1.000 50003850 P Turkey, fat 0.310000 1.000 1.000 50003851 P Turkey, fat - babyfood 0.310000 1.000 1.000 50003860 P Turkey, skin 0.310000 1.000 1.000 50003861 P Turkey, skin - babyfood 0.310000 1.0 00 1.000 60003010 P Poultry, other, meat 0.013000 1.000 1.000 60003020 P Poultry, other, liver 0.033000 1.000 1.000 60003030 P Poultry, other, meat byproducts 0.034000 1.000 1.000 60003040 P Poult ry, other, fat 0.310000 1.000 1.000 60003050 P Poultry, other, skin 0.310000 1.000 1.000 70001450 P Egg, whole 0.062000 1.000 1.000 70001451 P Egg, whole - babyfood 0 .062000 1.000 1.000 70001460 P Egg, white 0.062000 1.000 1.000 70001461 P Egg, white (solids) - babyfood 0.062000 1.000 1.000Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 18 of 26 70001470 P Egg, yolk 0.062000 1.000 1.000 700014 71 P Egg, yolk - babyfood 0.062000 1.000 1.000 86010000 O Water, direct, all sources 0.002600 1.000 1.000 86020000 O Water, indirect, all sources 0.002600 1.000 1.000 95001280 O Cottonseed, oil 0.600000 1.000 0.025 95001281 O Cottonseed, oil - babyfood 0.600000 1.000 0.025 95001300 O Cranberry 0.140000 1.000 1.000 95001301 O Cranberry - babyfood 0.140000 1.000 1 .000 95001310 O Cranberry, dried 0.140000 1.000 1.000 95001320 O Cranberry, juice 0.140000 1.100 1.000 95001321 O Cranberry, juice - babyfood 0.140000 1.100 1.000 95003590 O Strawberry 0.140000 1.000 1.000 95003591 O Strawberry - babyfood 0.140000 1.000 1.000 95003600 O Strawberry, juice 0.140000 1.000 1.000 95003601 O Strawberry, juice - babyfood 0.1400 00 1.000 1.000 95003620 O Sugarcane, sugar 0.125000 1.000 1.000 95003621 O Sugarcane, sugar - babyfood 0.125000 1.000 1.000 95003630 O Sugarcane, molasses 0.125000 1.000 1.000 95003631 O Sugarcane, molasses - babyfood 0.125000 1.000 1.000 95003800 O Tomato, Tree 0.161000 1.000 1.000Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 19 of 26



### Attachment 3: DEEM - FCID  Chronic Results File U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for NOVALURON (1994 - 98 data) Residue file name: C: \ Documents and Settings \ jlangsda \ My Documents \ Chemicals \ Novaluron \ Sorghum \ DEEM \ Sent to Reviewers \ 124002 - chronic - 2009 - JLV__04 - FEB - 10.R98 Adjustment factor #2 used. Analysis Date 02 - 05 - 2010/07:36:09 Residue file dated: 02 - 05 - 2010/07:35:49/8 Reference dose (RfD, Chronic) = .011 mg/kg bw/day

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

------------------------------------------------------------------------------- Total Exposure

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

-------------------------------------- ------------- --------------- U.S. Population (total) 0.001206 11.0% U.S. Population (spring season) 0.001184 10.8% U.S. Population (summer season) 0.001335 12 .1% U.S. Population (autumn season) 0.001195 10.9% U.S. Population (winter season) 0.001105 10.0% Northeast region 0.001213 11.0% Midwest region 0.001173 10.7% Southern region 0.001200 10.9% Western region 0.001245 11.3% Hispanics 0.001179 10.7% Non - hispanic whites 0.001087 9.9% Non - hispanic blacks 0.001726 15.7% Non - hisp/non - white/non - black 0.001753 15.9% All infants (< 1 year ) 0.001955 17.8% Nursing infants 0.001113 10.1% Non - nursing infants 0.002275 20.7% Children 1 - 6 yrs 0.002960 26.9% Children 7 - 12 yrs 0.001580 14.4% Females 13 - 19 (not preg or nursing) 0.000901 8.2% Females 20+ (not preg or nursing) 0.000933 8.5% Females 13 - 50 yrs 0.000934 8.5% Females 13+ (preg/not nursing) 0.000942 8.6% Females 13+ (nursing) 0.001060 9.6% Males 13 - 19 yrs 0.0 01136 10.3% Males 20+ yrs 0.000936 8.5% Seniors 55+ 0.001057 9.6% Children 1 - 2 yrs 0.003537 32.2% Childr en 3 - 5 yrs 0.002771 25.2% Children 6 - 12 yrs 0.001700 15.5% Youth 13 - 19 yrs 0.001021 9.3% Adults 20 - 49 yrs 0.000884 8.0% Adults 50+ yrs 0.001027 9.3% Females 13 - 49 yrs 0.000874 7.9%

-------------------------------------------------------------------------------Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 20 of 26 

### Attachment 4: Usage Report Package in Support of Registration for the Insecticide Novaluron (124002), BEAN DP# 371221 (Memo, A. Grube, 17 - NOV - 2009)Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 21 of 26Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 22 of 26Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

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### Attachme nt 5: Percent Crop Treated for New Use (PCTn): Novaluron (124002) Use on

Sorghum, DP# 371615 (Memo, C. Doucoure et al. , 29 - DEC - 2009)Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 24 of 26Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

Page 25 of 26Novaluron Dietary Exposure & Risk Assessment DP#: D374419

PC Code: 124002

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### The Confidential Attachment (page 5) of this document has not been included .