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### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY **WASHINGTON, D.C. 20460 OFFICE OF**  **CHEMICAL SAFETY AND POLLUTION PREVENTION** 



### MEMORANDUM **DATE:** April 20, 2015 **SUBJECT: Novaluron.**  Chronic Dietary (Food and Drinking Water) Exposure and Risk

Assessment for the Proposed Uses on Avocado; Carrot; Succulent Bean; Updated Crop Groupings for Vegetable, Fruiting, Crop Group 8 - 10; Fruit, Pome, Crop Group 11 - 10; Cherry

Subgroup 12 - 12A; Peach Subgroup 12 - 12B; and Plum Subgroup 12 - 12C; and Revisions to the L abel to Include Uses on Greenhouse Grown Cucumber . **PC Code:** 124002 **DP Barcode:** D 426069 **Decision No.:** 487502 **Registration No. :**  53883 - GGL **Petition No.:** 4E8241 **Regulatory Action:**  Section 3 Registration **Risk Assessment Type:** Dietary Exposure **Case No.:** 7615 **T XR No.:**  NA **CAS No.:** 116714 - 46 - 6 **MRID No.:** NA **40 CFR:** § 180.598 

### FROM: Richard Duncan, Associate Toxicologist

Department of Pesticide Regulation California Environmental Protection Agency and Julie L . Van Alstine, MPH, Environmental Health Scientist Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED ; 7509P) **THROUGH:** Meheret Negussie, Chemist

William Cutchin, Chemist Dietary Exposure Science Advisory Council (DESAC) HED (7509P) and George F. Kramer, Ph.D., Branch Senior Chemist RAB1/HED (7509P) **TO:** Barbara Madden (RM 05)/Laura Nollen/Sidney Jackson Registration Division (RD; 7505P)Novaluron Dietary Exposure & Risk Assessment D426069

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### Executive Summary A chronic aggregate dietary (food and drinking water) exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM - FCID) Version 3.16, which uses food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey , What We Eat in America, (NHANES/WWEIA) from 2003 through 2008. The anal ys is was performed to support a Section 3 request fo r the proposed use of novaluron on avocado, carrot, and succulent bean s , updated crop groupings for f ruiting v egetable group 8 - 10, p ome f ruit group 11 - 10, c herry s ubgroup 12 - 12A, p each s ubgroup 12 - 12B, and p lum s ubgroup 12 - 12C , and the addition of greenhouse - grown cucumbers to the label . This memorandum was reviewed b y two peer reviewers of the DESAC, per DESAC Standard Operating Procedure (SOP) 2012.1. Acute Dietary

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

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

(Food and Drinking Water) Exposure and Risk Results and Characterization A partially

refined chronic dietary

(food and drinking water) exposure and risk assessment was conducted for all established uses and drinking water. Environmental Fate and Effects Division (EFED) provided estimated drinking water concentrations (EDWCs) , which were incorporated directly into the anal ys is. The chronic analy sis also incorporated average percent crop treated (PCT) data from the Biologic al and Economic Analy sis Division (BEAD) for apples, blueberries, cabbage, cauliflower, cotton, dry beans , pears, peppers, potatoes, strawberries, and tomatoes , and average pe rcent crop treated for new use (PCTn) data for the recently registered grain sorghum and sweet corn uses. The grain sorghum and sweet corn PCTn data provided by BEAD are the most recent PCT data available for these commodities. For the remaining commodities, 100% CT was assumed. Anticipated residues (ARs) for meat, milk, hog, and poultry commodities were calculated using average field trial residues, average PCTn data for grain sorghum and sweet corn, average PCT data for apple and cotton, and assumed 100% CT for sugarcane, aspirated grain fractions (AGF), and cowpea seed. The chronic anal ys is also incorporated tolerance - level residues for the recentl y registered soybean and peanut commodities, average field trial residues for the majority of commodities, average greenhouse trial residues for tomatoes and cucumbers , and, due to the registered use in food - and feed - handling establishments, half of the limit - of - quantitation (LOQ) residues for food commodities other than those cover ed b y a higher tolerance as a result of use on growing crops. Empirical processing factors for apple juice (translated to pear and stone - fruit juice), cottonseed oil, dried plums, and tomato paste and purée, and DEEM (ver. 7.81) default processing factors for the remaining processed commodities were also incorporated. 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 expos ure results in a risk estimate that is 2 8 % of the chronic population - adjusted dose (cPAD) for the general U.S. population and 7 3 % of the cPAD for children 1 - 2 years old, the most highly exposed population subgroup.Novaluron Dietary Exposure & Risk Assessment D426069

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### Cancer Dietary

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

assessment was not conducted because novaluron is classified as “not likel y to be carcinogenic to humans.” **I. Introduction**  Dietary risk assessment incorporates both exposure and toxicity of a g iven pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose that HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the populatio n - 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 concerned when estimated dietary risk exceeds 100% of the PAD. References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21 - JUN - 2000, web link: http://www.regulations.gov/#!documentDetail;D=EPA - HQ - OPP - 2007 - 0780 - 0001 ; or see SOP 99.6 (20 - AUG - 1999). The most recent dietary

risk assessment for novaluron wa s conducted by J. Van Alstine (5 - FEB 201 4 ; D 415835 ). **II. Food Residue Information**  Residues 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 chlorophenylurea degradate (1 - [3 - chloro - 4 - (1,1,2 - trifluoro - 2 - trifluoromethoxyethox y)phenyl ]urea), and the chloroaniline degradate (3 - chloro - 4 - (1,1,2 - trifluoro - 2 - trifluoromethox yethoxy)aniline) (Memo, G. Kramer et al. , 03 - FEB 04; D297646). Established Tolerances: Tolerances for residues of novaluron are established under 40 CFR §180.598 in/on a wide variety of crops at levels ranging from 0.0 1 to 50 ppm. Tolerances for residues of novaluron are also established in/on the following livestock commodities: eggs, milk, milk fat, and the meat, fat, kidney , liver, and meat by products (except kidney

and liver) of cattle, goat, horse, sheep, poultry , and hog. Additi onally , novaluron is registered for use in food and feed - handling establishments, and a tolerance of 0.01 ppm (the LOQ) has been established for residues in/on food and feed commodities other than those covered b y a higher tolerance as a result of use on growing crops. Recommended Tolerances : Based on the residue chemistry data submitted with the current petition, HED recommended for establishment of the following tolerances for residues of the insecticide novaluron, including its metabolites and degradates, in or on the commodities listed belo w (Memo, J. Van Alstine, D418739 ) :Novaluron Dietary Exposure & Risk Assessment D426069

Page 4 of 30 **Table 1**  **. Tolerance Summary for Novaluron.** Commodity Proposed Tolerance (ppm) HED - Recommended

Tolerance (ppm) Comments;

Correct Commodity Definition Avocado 0.60 0.60 Carrot 0.05 0.05 Bean 0.60 0 .7 0 Harmonize with Codex MRL Bean, succulent1 Vegetable, fruiting, group 8 - 10 2 1.0 1.0 Fruit, pome, group 11 - 10 3 2.0 3 .0 Harmonize with Codex MRL Cherry subgroup 12 - 12A4 8.0 8.0 Peach subgroup 12 - 12B 5 1.9 1.9 Plum subgroup 12 - 12C 5 1.9 1.9 Vegetable, cucurbit, group 9 -- 0.20 Harmonize with Codex MRL Plum, prune, dried -- 3.0 Harmonize with Codex MRL 1 This tolerance will replace the existing tolerance of 0. 60 ppm on bean, succulent, snap . The dry bean tolerance will not be impacted. 2 This tolerance wi ll replace the existing tolerances of 1.0 ppm on v egetable, fruiting, group 8, and also cocona, African eggplant, pea eggplant, scarlet eggplant, goji berry, garden huckleberry, martynia, naranjilla, okra, roselle, sunberry, bush tomato, currant tomato, and tree tomato. 3 This tolerance wi ll replace the existing tolerance of 2.0 ppm on f ruit, pome, group 11. 4 This tolerance wi ll replace the existing tolerance of 8.0 ppm on c herry. 5 These tolerance s will replace the existing tolerance of 1.9 ppm on f ruit, stone, group 12, except cherry. 

### Residues used in the Chronic Analysis : The current chronic dietary anal ys is incorporated average PCT data for apples, blueberries, cabbage, cauliflower, cotton, dry beans, pears, peppers, potatoes, strawberries, and tomatoes, average PCTn data for grain sorghum and sweet corn, and 100% CT for the remaining commodities. HED assessed the grain sorghum use in 2010 and the sweet corn use in 2011 , and the PCTn data provided by BEAD are the most recent PCT data available for these commodities. The chronic dietary anal ys is was refined through the use of average field trial residues for the majority of commodities, avera ge greenhouse trial residues for tomatoes and cucumbers , and calculated ARs for meat, milk, hog, and poultry commodities . T olerance - level residues were used for the recently registered peanut and soy bean commodities. Additionally , due to the registered u se in food - and feed - handling establishments, half - LOQ residues (0.01 ppm/2 = 0.005 ppm) were used for food commodities other than those covered b y a higher tolerance as a result of use on growing crops. In accordance 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. Empirical processing factors for apple juice (translated to pear and stone - fruit juice), cottonseed oil, dried plums, and tomato paste and purée were utilized along with DEEM (ver. 7.81) default processing factors for the remaining processed commodities. The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010; however, the samples were not anal yz ed for novaluron. As a result, residue data from monitoring studies were not used for fish in this assessment. Ba sed on the established tolerance for residues of novaluron in/on food commodities other than those covered by a higher tolerance due to use of novaluron in food - and feed - handling establishments, a half - LOQ residue of 0.005 ppm was used for fish commoditie s.Novaluron Dietary Exposure & Risk Assessment D426069

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### Attachment 1 summarizes the residue, processing factor, and PCT and PCTn data that were incorporated into the current anal ys is. Calculation of ARs in Meat, Milk, Poultry, and Eggs The potential for secondary transfer of novaluron residues of conc ern in meat, milk, and eggs exists because there are livestock feedstuffs associated with the registered novaluron uses. Carrot culls, a carbohydrate concentrate, are the only livestock feed item associated with the current petition. Revisions to livesto ck dietary burdens and tolerances were not required for this petition since the incorporation of carrot culls into th e dairy cattle livestock diet w ould not result in higher livestock dietary burdens . The most recent dietary exposure and risk assessment f or novaluron includes livestock dietary burden calculations that incorporated average PCT (C. Doucoure, 05 - DEC - 2012) and PCTn (C. Doucoure, et al. , 01 - FEB - 2013) data (Memo, J. Van Alstine, 15 - MAY - 2013; D401262). Please refer to Attachment 1 for the meat, milk, poultry , and hog ARs used in this assessment. **III. Percent Crop Treated**  BEAD recently

provided a Screening - Level Usage Anal ys is (SLUA) memorandum entitled, “Usage Report Pa ckage in Support of Novaluron ( 124002), BEAN DP# 421177 ” (C. Doucoure, 30 - JUN - 201 4). The chronic dietary analy sis incorporated average PCT data for apples (10%), blueberries (<1%), ( cabbage ( 5 %), cauliflower (<2.5%), cotton (<2.5%), dry beans (<1%), pears (15%), peppers (<2.5%), potatoes (<2.5%), strawberries (35%), and tomatoe s (<2.5% ) and average PCTn data for grain sorghum (2%) and sweet corn (36%). 100% CT was assumed for the remaining food commodities. Livestock dietary burdens of novaluron were calculated based on the registered uses, and incorporated average field trial residues, PCTn data for grain sorghum (2%) and sweet corn (36%), average PCT data for apple (10%) and cotton (<2.5%), and an assumption of 100% CT for sugarcane, AGF, and cowpea seed. 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 PCT data utilized in the chronic dietary assessment. Pleas e refer to Attachments 4 and 5 for the PCT and PCTn data provided b y BEAD. **IV. Drinking Water Data**  The residues of concern in drinking water for purposes of risk assessment are novaluron, the chlorophenylurea degradate (1 - [3 - chloro - 4 - (1,1,2 - trifluoro - 2 - trifluoromethox yethox y) phenyl]urea), and the chloroaniline degradate (3 - chloro - 4 - (1,1,2 - trifluoro - 2 - trifluoromethoxyethox y) aniline) (Memo, G. Kramer et al. , 03 - FEB - 04; D297646). The drinking water residues used in the dietary risk assessment were provide d by EFED in the following memorandum: “Drinking Water Assessment in Support of the New Indoor and Outdoor non - food Use of Novaluron for Pest Control” ( H. Zhong , 07 - AUG - 2013; D412441) and were incorporated directly into this dietary assessment into the fo od categories “water, direct, all sources” and “water, indirect, all sources.” EFED has indicated that revised drinking water estimates are not required based on the proposed uses ( Memo, H. Zhong, 2 - SEP - 2014; D418740 ).Novaluron Dietary Exposure & Risk Assessment D426069

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### EFED completed the drinking water assessment in support of the proposed use of novaluron for indoor and outdoor use to control fleas, roaches, litter beetles, ants, and flying insect pests; and flies, beetles, and other insects in cattle, poultry , and horse operations. Two formulations w ere evaluated: 1) N+P Regulator, a liquid spray co - formulated with py

riprox yf en; and 2) Novaluron 0.2G, a granular formulation. The single maximum application rate s range from 0.023 to 0.872 lb ai/A and the seasonal maximum application rate s range from 0 .14 to 14.82 lb ai/A. During the treatment for poultry

/horse/cattle operations, the animal litter/manure is expected to be treated with novaluron and then used on field crops annually as fertilizer for nitrogen supplement. The novaluron annual applicatio n rates based on nutrient content conversion from the novaluron application to poultry

litter and animal manure varied from 0.002 to 0.232 lb ai/A. Surface and ground water EDWCs were calculated using the Pesticide Root Zone Model/Exposure Analy sis Modeli ng S ys tem (PRZM/EXAMS) , the Screening Concentration in Ground Water ( S CI GROW), and Pesticide Root Zone Model for Ground Water (PRZM - GW) models . **Surface Water** The EDWCs for the parent compound (novaluron) and two degradates of concern in surface water, the chlorophenyl urea (registrant s ynonym= 275 - 352I) and chloroaniline (275 - 309I) degradates, were modeled with PRZM/EXAMS, a Tier II model, assuming 100% of the standard reservoir watershed is treated with novaluron (percentage crop area or PCA = 1). The acute EDWC of parent novaluron in surface water is 4.81 μg/L (poultry operation via granular application) and exceeds the solubility of novaluron (3 μg/L), which is expected to be the upper bound environmental concentration. The estimated 1 - in - 10 - year annual average (non - cancer chronic) and the 30 - ye ar annual average (cancer) are not expected to exceed 0.61 μg/L and 0.38 μg/L . The surface water EDWCs for the chlorophenyl urea degradate are not expected to exceed 8.77 μg/l, 6.01 μg/l, and 3.21 μg/l, and the surface water EDWCs for the chloroaniline degradate are not expected to exceed 12.59 μg/l, 10.05 μg/l, and 6.05 μg/l for acute, non - cancer chronic, and cancer assessments, respectivel y. Table 2 summarizes the surface water EDWCs that result in the highest total exposure estimate. Since the total novaluron and degradate surface water EDWCs are less than the total ground water EDWCs, ground water EDWCs were used in the assessment. **Table 2**  **. Summary of Novaluron EDWCs from Surface Water.**  **1** Scenario (PCA = 1) Max Single Rate

/ Annual, (lb ai/A) (Application T ype) 1 - in - 10 - Y ear Annual P eak (μg/L) 1 - in - 10 - Y ear Annual

M ean (μg/L) 30 - Y ear Annual

Mean (μg/L) Novaluron Poultry PA Turf 0.872 / 14.82

(Granular) 3 2 0.6099 0.3801

Chlorophenyl Urea Degradate (275 - 352I) 3 Poultry PA Turf 0.1658 / 2.8194

Degradate in soil 8.7693 6.0087 3.2110

Chloroaniline Degradate (275 - 309I) 4 Poultry PA Turf 0.0467 / 0.7938

Degradate in soil 12.5930 10.0460 6.0513 Total of Novaluron and Chlorophenyl Urea and Chloroaniline Degradates Poultry PA Turf -- 24.3623 16.6646 9.6424 1 This table summarizes the highest EDWCs for novaluron and its degradates resulting from the poultry PA turfNovaluron Dietary Exposure & Risk Assessment D426069

Page 7 of 30 scenario. EFED provided several scenarios and corresponding EDWCs. The poultry PA turf scenario provides the highest total EDWC for surface water. 2 The solubility of novaluron is 3 μg/L. The modeled EDWC for novaluron was 4.8070 μg/L ; however, since the EDWC exceeds the solubility of novaluron , 3 μg/L was used . 3 Novaluron application rate is adjusted by 26.6% max degradate formation and 71.5% mo lecular weight ( MW ) ratio . 4 Novaluron application rate is adjusted by 8.5% max degradate formation and 63% MW ratio. 

### Ground Water Novaluron appears to be immobile in soils according to the McCall classification (McCall et al. , 1980). It is unlikel y that novaluron would reach potable ground water resources; however, both the chlorophenylurea and chloroaniline degradates are mobile and persistent in soil, especially under anaerobic conditions. The estimated concentrations of novaluron, chlorophenylurea, and chloroaniline in shallow ground water sources were modeled using the SCI - GROW and PRZM GW models. The Tier I SCI - GROW screening model was used to estimate the upper bound ground water concentrations for novaluron, chlorophenylurea, and chloroaniline. The model simulates ground water EDWCs likely

to occur when the pesticide is used at the m aximum allowable rate in areas where ground water is particularl y vulnerable to contamination. EDWCs were simulated for the poultry operation application scenario using the SCI - GROW model and the results are summarized in Table 3 . **Table 3**  **. EDWCs for Ground Water Sources Based on the Tier I SCI**  **- GROW 2.3 Model and the Highest**  **Maximum Application Rate for Poultry Operations.** Application Rate (lb/acre) No. of Applications Groundwater Concentration (ppb) Novaluron 0.8720 17 8.72E - 02 Chlorophenyl Urea Degradate 1 0.1658 17 7.00E - 02 Chloroaniline Degradate 2 0.0467 17 3.55E - 01 Total of Novaluron and Chlorophenyl Urea and Chloroaniline Degradates 5.12E - 01 1 Application rate of chlorophenyl urea d egradate is based on the maximum formation rate of 26.6 % from parent novaluron found in the aerobic soil metabolism study (MIRD 44961009) and 71.5% MW ratio. 2 Application rate of chloroaniline degradate is based on 8.5% max degradate and 63% formation from parent novaluron and molecular weight conversion (MWpar = 492.7; MW deg = 310.6). 

### The ground water EDWCs were also simulated using the newer PRZM - GW model for six vulnerable sites in VA, FL, GA, NC, and WI using different applications scenarios. The proposed poultry

operation uses combined with the WIcorn sc enario provided the highest total EDWC of all of the scenarios and is summarized in Table 4 . Although the novaluron and chlorophenylurea PRZM - GW EDWCs were considered invalid because of incomplete simulation, the WIscenario still results in the highest combined EDWC. **Table 4**  **. Summary of Novaluron EDWCs from Ground Water Using PRZ** **M -**  **GW Modeling for Poultry Operations.**  **1**

Crop/Scenario Highest Daily Value (μg/L) Post Breakthrough

Average (μg/L) Average Simulation

Breakthrough Time (Days) Novaluron Wisconsin Corn - WI Central Sands Met File (14920.dvf) 2.58E - 18 Incomplete Incomplete C hlorophenyl Urea DegradateNovaluron Dietary Exposure & Risk Assessment D426069

Page 8 of 30 **Table 4**  **. Summary of Novaluron EDWCs from Ground Water Using PRZ** **M -**  **GW Modeling for Poultry Operations.**  **1**

Crop/Scenario Highest Daily Value (μg/L) Post Breakthrough

Average (μg/L) Average Simulation

Breakthrough Time (Days) Wisconsin Corn - WI Central Sands Met File (14920.dvf) 0.00815 Incomplete Incomplete Chloroaniline Degradate Wisconsin Corn - WI Central Sands Met File (14920.dvf) 84.2 77.8 15,661

Total of Novaluron and Chlorophenyl Urea and Chloroaniline Degradates Wisconsin Corn - WI Central Sands Met File (14920.dvf) 84.21 77.8 15,661 1 EFED simulated ground water EDWCs using a newer PRZM - GW model for six vulnerable sites in VA, FL, GA, NC , and WI. This table summarizes the highest EDWCs for novaluron and its degradates that resulted from the proposed poultry operation uses combined with the Wisconsin Corn - WI Central Sands site. The WI site provides the highest total EDWC, and was used in the dietary exposure assessment. A value of 0 was used for novaluron and chlorophenyl urea in the total calculation since the post -breakthrough ave rages are incomplete for these EDWCs. 

### EDW Cs Used in the Assessment: The 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. Since th e residues of concern in drinking water for risk assessment purposes are novaluron, the chlorophenylurea degradate, and the chloroaniline degradate, these EDWCs were calculated using a molecular weight conversion and then combined for each model ed scenari o. The degradates are assumed to have equal toxicity to the parent. The chronic dietary exposure and risk assessment incorporated the highest total EDWC of 77.8 μg/L (0.0778 ppm) that was simulated using the PRZM - GW model with the proposed poultry operation use and WIcorn scenario. **V. DEEM**  **- FCID Program and Consumption Information**  A novaluron chronic dietary exposure assessment was conducted using DEEM - FCID, Version 3.16, which incorporates consumption data from USDA’s NHANES/WWEIA from 2003 through 2 008. The data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey day s. Foods “as consumed” (e.g., apple pie) are linked to EPA - defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups. However, for acute exposure assessment, consumption data are retained as individual consumption events. Based on anal ys is of the 2003 - 2008 WWEIA consumption data, which took into account dietary patterns and survey

respondents, HED conclud ed that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50 - 99 ye ars old. For a chronic dietary

exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average dail y consumption estimate for that food/food form to prod uce 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 residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percentNovaluron Dietary Exposure & Risk Assessment D426069

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### 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 Review 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 of increased susceptibility

in the rat and/or rabbit developmental toxicity studies at levels up to the limit dose. In addition, 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 5 is a summary

of the decisions made b y the HIARC concerning dietary exposure assessment. These endpoints have been confirmed by the risk assessment team as appropriate for the current risk assessment. **Table 5**  **. Summary of Toxicological Doses and Endpoi nts for Novaluron for Use in Dietary Exposure Risk**  **Assessments.** Exposure/ Scenario POD Uncertainty/FQ PA SF RfD, PAD, LOC

for Risk Assessment Study and Toxicological Effects Ac ute Dietary (General Population, including Infants and Children) None None None 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 UF A = 10X

UF H = 10X FQPA SF = 1X Chronic RfD =

0.011 mg/kg/day cPAD = 0.011 mg/kg/day **Comb ined chronic** 

**toxicity/carcinogenicity feeding in rat** LOAEL = 30.6 mg/kg/day based on erythrocyte damage resulting in a compensatory regenerative anemia. Cancer (oral, 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 determine risk associated with lower environmentally relevant human exposures. NOAEL = no - observed adv erse - 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 (c = chronic). RfD = reference dose. 

### VII. **Results/Discussion** As stated previousl y, for a chronic assessment, HED is concerned when dietary risk exceeds 100% of the cPAD. The chronic analy sis was performed using DEEM - FCID (ver. 3.16). The DEEM - FCID anal ys is estimates the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 6 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 - 99 years old, and females 13 - 49 years old. The resulting food and drinking water exposureNovaluron Dietary Exposure & Risk Assessment D426069

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### estimates were not of concern to HED (  100% cPAD) . The chronic dietary exposure estimates are 2 8 % of the cPAD for the general U.S. population and 7 3 % of the cPAD for children 1 - 2 ye ars old, the most highly exposed population subgroup. **Table 6**  **. Summary of Chronic Dietary Exposure (Food and Drinking Water) and Risk for Novaluron 1**  **.** Population Subgroup Ac ute 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 0.003 071 2 8 N/A N/A All Infants (<1 year old) 0.006 289 5 7 **Children 1 -**  **2 years old 0.008**  **014 7**  **3** Children 3 - 5 years old 0.005 711 5 2 Children 6 - 12 years old 0.003 746 3 4 Youth 13 - 19 years old 0.0024 24 22 Adults 20 - 49 years old 0.002 659 2 4 Adults 50 - 99 years old 0.002 671 2 4 Females 13 - 49 years old 0.0026 40 24 1 Population with the greatest exposure is in bold. 

### VIII. **Characterization of Inputs/Outputs** The chronic dietary

assessment was refined through the use of average field trial residues, average greenhouse trial residues for tomatoes and cucumbers , and ARs for meat, milk, hog, and poultry commodities. Empirical processing factors for apple juice (translated to pear and stone fruit juice), cottonseed oil, dried plums, and tomato paste and purée were utilized along with DEEM (ver. 7.81) default processing factors for the remaining processed commodities. In accordance with HED SOP 2000.1, average fiel d trial residues were translated from representative commodities in the crop group to other commodities in that crop group as needed (see Attachment 1). Despite this, HED concludes that the chronic estimates are still highl y conservative since they

assume d average residues based on field trial data [maximum application rate; minimum pre - harvest interval (PHI); and frozen immediately after harvest]. The current chronic dietary

anal ys is also incorporated average PCT data for apples, blueberries, cabbage, cauliflower, cotton, dry

beans, pears, peppers, potatoes, strawberries, and tomatoes, and average PCTn data for sorghum and sweet corn. 100% CT was assumed for the remaining commodities. ARs for meat, milk, hog, and poultry commodities were calculated using average field trial residues, average PCTn data for grain sorghum and sweet corn, average PCT data for apple and cotton, and 100% CT for sugarcane, AGF, and cowpea seed. The current chronic anal ys is could be further refin ed through the use of monitoring data and preparation/cooking factors. **IX. Conclusions**  A chronic dietary

risk assessment was conducted using DEEM - FCID (ver. 3.16) for all established uses and drinking water. 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 2 8 % of the cPAD for the general U.S. population and 7 3 % of the cPAD for children 1 - 2 years ol d, the most highly exposed population subgroup. HED is confident that the assessment does not underestimate risk to the general U.S. population or any

population subgroup. **X. List of Attachments** Novaluron Dietary Exposure & Risk Assessment D426069

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### Attachment 1: Processing Factors, ARs, and Average Fiel d Trial Residues Used in Assessment Attachment 2: DEEM - FCID Chronic Residue Input File Attachment 3: DEEM - FCID Chronic Results File Attachment 4: Usage Report Package in Support of Novaluron (124002), BEAN DP# 421177

(Memo, C. Doucoure, 30 - JUN - 201 4 ) Att achment 5: Update of Percent Crop Treated for New Use (PCTn): Novaluron (124002) Use

on Sorghum and Sweet Corn” (C. Doucoure, et al ., 01 - FEB - 2013) RDI: DE SAC Reviewers ( 26 - FEB - 2015 ); G. Kramer ( 23 - FEB - 2015 ) DP No.: D426069 Petition No.: 4E8241 PC Code: 124002 J. L.Van Alstine:S - 10951:PY - S:(703)603 - 8866:7509P:RAB1Novaluron Dietary Exposure & Risk Assessment D426069

Page 12 of 30 

### Attachment 1: Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment **Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.** Crop (Listed in Crop Group Order) Commodity Processing Factor Residue

(ppm) 1 Average

PCT Comments food commodities/feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) from uses in food/feed handling establishments All 1 0.005 100% 1⁄2 LOQ residue [residues for all covered food matrices samples treated at a 3X application rate were <LOQ (<0.010 ppm) except for one sample of bread collected 4 hours post - application]; processing factors were not applied to these commodities; marked food - handling estab lishment (FHE) carrot All 1 0.025 100% 1⁄2 LLMV [all measured residues were less than the lowest level of method validation (LLMV; 0.05 ppm)] tuberous and corm vegetables (subgroup 1C) All 1 0.025 <2.5% 1⁄2 LOQ residue (from US field trials); DEEM (ver. 7.78) default proc. factor of 6.5 used for potato, dry and potato, flour; average PCT assumed for potato only; other commodities use 100% CT (SLUA; C. Doucoure, 05 - DEC - 2012; D407102) dry/flour (potato) 6.5 0.025 <2.5% Swiss chard All 1 4.2 100% average Swiss chard field trial residue Brussels sprouts, cabbage, Chinese Napa cabbage, kohlrabi All 1 0.051 5 % average cabbage (without wrapper leaves) field trial residue; average PCT assumed for cabbage only; other commodities use 100% CT (SLUA; C. Doucoure, 30 - JUN - 2014; D421177) ; cabbage residues (without wrapper leaves) were translated to Brussels sprouts, Chinese Napa cabbage, and kohlrabi using HED SOP 2000.1 broccoli, Chinese broccoli, Chinese mustard cabbage, cauliflower All 1 0.106 <2.5% average broccoli field trial residue; average PCT assumed for cauliflower only; other commodities use 100% CT (SLUA; C. Doucoure, 05 - DEC - 2012; D407102); broccoli residues were translated to Chinese broccoli, Chinese mustard cabbage, and cauliflower using HED SOP 2 000.1 broccoli raab, Chinese bok choy cabbage, collards, kale, mustard greens, rape greens ( Brassica , leafy greens, subgroup 5B), and turnip greens All 1 5.33 100% average mustard green field trial residue; mustard greens residues were translated to broccoli raab, Chinese bok choy cabbage, collards, kale, rape greens, and turnip greens using HED SOP 2000.1 soybean All 1 0.07 100% tolerance - level residue; refinements are not required at this time lima bean, succulent All 1 0.0502 100% average lima bean field trial residue broad bean, succulent; cowpea, succulent; snap bean, succulent; soybean, vegetable All 1 0.18 100% average succulent snap bean pods with seed field trial residue dry bean s All 1 0.065 <1% average dry bean seed field trial residue ; average PCT for from SLUA memo (SLUA; C. Doucoure, 30 - JUN - 2014; D421177) tomato, tomatillo, tree tomato, goji berry RAC 1 0.161 <2.5% overall (small - & large - fruit varieties) average of the greenhouse trial residue; average PCT assumed for tomato only; other commodities use 100% CT (SLUA; C. Doucoure, 30 - JUN - 2014; D421177) ; tomato residues were translated to tomatillo and tree tomato using HED SOP 2000. 1Novaluron Dietary Exposure & Risk Assessment D426069

Page 13 of 30 **Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.** Crop (Listed in Crop Group Order) Commodity Processing Factor Residue

(ppm) 1 Average

PCT Comments dried 14.3 0.161 <2.5% overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. fact; average PCT assumed for tomato only ; other commodities use 100% CT (SLUA; C. Doucoure, 30 - JUN - 2014; D421177) juice 1.5 0.161 <2.5% overall average of the greenhouse trial residue; DEEM (ver. 7.78) default proc. fact; average PCT assumed for tomato only; other commodities use 100% CT (SLUA; C. Doucoure, 30 - JUN - 2014; D421177) purée 0.7 0.161 <2.5% overall average of the greenhouse trial residue; empirical proc. fact.; average PCT assumed for tomato only; other commodities use 100% CT (SLUA; C. Doucoure, 30 - JUN - 2014; D421177) paste 1.1 0.161 <2.5% overall average of the greenhouse trial residue; empirical proc. fact; average PCT assumed for tomato only; other commodities use 100% CT (SLUA; C. Doucoure, 30 - JUN - 2014; D421177) bell pepper, eggplant RAC 1 0.14 <2.5% average bell pepper field trial residue; average PCT assumed for bell pepper only; use 100% CT for eggplant (SLUA; C. Doucoure, 30 - JUN - 2014; D421177) ; bell pepper residues were translated to eggplant using HED SOP 2000.1 non - bell pepper, okra RAC 1 0.16 < 2.5% average non - bell pepper field trial residue; average PCT assumed for non - bell pepper only; use 100% CT for okra (SLUA; C. Doucoure, 30 - JUN - 2014; D421177) ; non - bell pepper residues were translated to okra cantaloupe, honeydew melon, watermelon All 1 0.055 100% average cantaloupe field trial residue; cantaloupe residues were translated to honeydew melon, and watermelon using HED SOP 2000.1 cucumber, Chinese waxgourd, balsam pear All 1 0.0 542 100% average greenhouse cucumber field trial residue; cucumber residues were translated to Chinese waxgourd and balsam pear using HED SOP 2000.1 summer squash, chayote fruit Christophe, pumpkin, winter squash All 1 0.044 100% average summer squash field trial residue; summer squash residues were translated to chayote fruit Christophe, pumpkin, and winter squash using HED SOP 2000.1

apple, crabapple RAC, sauce 1 0.578 10% weighted average field trial residue (of US and Canadian concentrate and dilute average residues); average PCT assumed for apple only (SLUA; C. Doucoure, 05 - DEC - 2012; D407102); apple residues were translated to the remaining crabapple using HED SOP 2000.1 dried 8 0.578 10% weighted average field trial residue (of US and Canada concentrate and dilute average residues); DEEM (ver. 7.78) default proc. fact.; average PCT assumed for apple only; other commodities use 100% CT (SLUA; C. Doucoure, 05 - DEC 2012; D407102) juice 0.1 0.578 10% weighted average field trial residue (of US and Canada concentrate and dilute average residues); em

pirical proc. fact.; average PCT assumed for apple only; other commodities use 100% CT (SLUA; C. Doucoure, 05 - DEC - 2012; D407102)Novaluron Dietary Exposure & Risk Assessment D426069

Page 14 of 30 **Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.** Crop (Listed in Crop Group Order) Commodity Processing Factor Residue

(ppm) 1 Average

PCT Comments

pear, loquat, quince RAC 1 0.833 15% weighted average field trial residue (of US and Canada concentrate and dilute average residues); average PCT assumed for pear only; other commodities use 100% CT (SLUA; C. Doucoure, 05 - DEC - 2012; D407102); pear residues were translated to loquat and quince using HED SOP 2000.1 dried 6.25 0.833 15% weighted average field trial residue (of U S and Canada concentrate and dilute average residues); DEEM (ver. 7.78) default proc. fact.; average PCT assumed for pear only; other commodities use 100% CT (SLUA; C. Doucoure, 05 - DEC 2012; D407102) juice 0.1 0.833 15% weighted average field trial residue (of US and Canada concentrate and dilute average residues); empirical apple proc. fact.; average PCT assumed for pear only; other commodities use 100% CT (SLUA; C. Doucoure, 05 - DEC - 2012; D407102) cherry RAC 1 2.17 100% average field trial residue juice 0.1 2.17 100% average field trial residue; empirical apple proc. fact. peach, nectarine, and apricot RAC 1 0.61 100% average peach field trial residue; peach residues were translated to nectarine and apricot crops using HED SOP 2000.1 dried (peach) 7 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 (apricot) 6 juice 0.1 0.61 100% average peach field trial residue; empirical apple proc. fact. plum RAC 1 0.403 100% average plum field trial residue dried 1 1.37 100% average plum field trial residue (0.403 ppm) x dried plum empirical processing factor (3.39) juice 0.1 1.37 100% average plum field trial residue (0.403 ppm) x dried plum empirical processing factor (3.39); empirical apple proc. fact. blueberry, currant, elderberry, gooseberry, and huckleberry (bushberry subgroup 13 - 07B) All 1 1.97 <1% average blueberry field trial residue; blueberry residues 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) ; average PCT assumed for blueberry only (SLUA; C. Doucoure, 30 - JUN - 2014 ; D421177) ; strawberry, cranberry [low growing berry subgroup 13 - 07G (except lowbush blueberry)] RAC 1 0.14 35% average strawberry field trial residue; strawberry residues were translated to cranberry 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); average PCT use for strawberry only; for cranberry use 100% CT juice (strawberry) 1 0.14 35% average strawberry field trial residue; DEEM (ver. 7.78) default proc. fact. of 1.1Novaluron Dietary Exposure & Risk Assessment D426069

Page 15 of 30 **Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.** Crop (Listed in Crop Group Order) Commodity Processing Factor Residue

(ppm) 1 Average

PCT Comments juice (cranberry) 1.1 used for cranberry juice; average PCT use for strawberry only; other commodities use 100% CT (SLUA; C. Doucoure, 05 - DEC - 2012; D407102) corn, sweet, kernel plus cob with husks removed All 1 0.025 36% 1⁄2 LLMV [all measured residues were less than the lowest level of method validation (LLMV; 0.05 ppm)] (PCTn memo: C. Doucoure, et al. , 01 - FEB - 2013) sorghum, grain, grain grain 1 1.23 2% average field trial residue; average PCT assumed for grain only (PCTn memo: C. Doucoure, et al. , 01 - FEB - 2013) cotton cottonseed oil 0.6 0.115 <2.5% average field trial residue for cottonseed; empirical processing factor; average PCT for cotton from SLUA memo (SLUA; C. Doucoure, 05 - DEC - 2012; D407102) meat of cattle, goat, horse, and sheep meat 1 0.047 100% AR dried beef 1.92 0.047 100% AR; DEEM (ver. 7.78) default proc. fact. meat byproducts (except liver and kidney) of cattle, goat, horse, and sheep meat byproducts 1 1.04 100% AR (meat peritoneal fat) fat (peritoneal) of cattle, goat, horse, and sheep fat 1 1.04 100% AR kidney of cattle, goat, horse, and sheep kidney 1 0.057 100% AR liver of cattle, goat, horse, and sheep liver 1 0.062 100% AR pork meat meat 1 0.00050 100% AR pork skin skin 1 0.011 100% AR (pork peritoneal fat) pork meat byproducts (except liver and kidney) meat byproducts 1 0.011 100% AR (pork peritoneal fat) pork fat (peritoneal) fat 1 0.011 100% AR pork kidney kidney 1 0.00061 100% AR pork liver liver 1 0.00067 100% AR milk milk, fat 1 1.96 100% AR, calculated assuming residues partition into fat [non - truncated whole milk secondary residue x 25 (maximum concentration factor for milk fat)] milk, nonfat solids 1 0.078 100% AR for whole milk, used to account for low residues observed in skim milk milk, water 1 0.005 100% FHE; All residues assumed to be associated with fat and solids milk, sugar 1 0.005 100% FHE; All residues assumed to be associated with fat and solids poultry meat meat 1 0.0025 100% ARNovaluron Dietary Exposure & Risk Assessment D426069

Page 16 of 30 **Table A.1. Processing Factors, ARs, and Average Field Trial Residues Used in the Chronic Assessment.** Crop (Listed in Crop Group Order) Commodity Processing Factor Residue

(ppm) 1 Average

PCT Comments poultry liver liver 1 0.0063 100% AR poultry meat byproducts (except kidney and liver) meat byproducts 1 0.059 100% AR (poultry abdominal fat) poultry fat (abdominal) fat 1 0.059 100% AR poultry skin skin 1 0.059 100% AR (poultry abdominal fat) poultry kidney kidney 1 0.0065 100% AR egg RAC 1 0.012 100% AR water, direct, all sources and water, indirect, all sources All 1 0.0778 100% Simulated using the PRZM - GW model with the proposed poultry operation use and WI corn scenario (H. Zhong, 07 - AUG - 2013; D412441). avocado All 1 0.192 100% average field trial residue peanut RAC 1 0.01 100% tolerance - level residue; refinements are not required at this time butter 1.89 0.01 100% tolerance - level residue; refinements are not required at this time; DEEM default processing factor oil 1 0.01 100% tolerance - level residue; refinements are not required at this time sugarcane All 1 0.125 100% average field trial residue 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; Memo, J. Van Alstine 23 - FEB - 2010, D374419; Memo, J. Van Alstine 15 - MAY - 2013; D401263.Novaluron Dietary Exposure & Risk Assessment D426069

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### Attachment 2: DEEM **- FCID Chronic Residue Input File**  Filename: C: \ Users \ jlangsda \ Documents \ Chemicals \ Novaluron \ 2014 Avocado, Carrot, Bean, Cucumber, and CG Tolerance Expansions \ Dietary Memo \ novaluron_chronic1_Feb 23 2015.R08 Chemical: Novaluron RfD(Chronic): .011 mg/kg bw/day NOEL(Chronic): 1.1 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 02 - 23 - 2015/09: 22:50 Program ver. 3.16, 03 - 08 - d

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0101050000 1AB Beet, garden, roots 0.005000 1.000 1.000 FHE 0101050001 1AB Beet, garden, roots - babyfood 0.005000 1.00 0 1.000 FHE 0101052000 1A Beet, sugar 0.005000 1.000 1.000 FHE 0101052001 1A Beet, sugar - babyfood 0.005000 1.000 1.000 FHE 0101053000 1A Beet, sugar, molasses 0.005000 1.000 1.000 FHE 01 01053001 1A Beet, sugar, molasses - babyfood 0.005000 1.000 1.000 FHE 0101067000 1AB Burdock 0.005000 1.000 1.000 FHE 0101078000 1AB Carrot 0.025000 1.000 1.000 0101078001 1AB Carro t - babyfood 0.025000 1.000 1.000 0101079000 1AB Carrot, juice 0.025000 1.000 1.000 0101084000 1AB Celeriac 0.005000 1.000 1.000 FHE 0101100000 1AB Chicory, roots 0.005000 1.000 1.000 FHE 0101168000 1AB Ginseng, dried 0.005000 1.000 1.000 FHE 0101190000 1AB Horseradish 0.005000 1.000 1.000 FHE 0101250000 1AB Parsley, turnip rooted 0.005000 1.000 1.000 FHE 0101251000 1AB Parsnip 0.005000 1.000 1.000 FHE 0101251001 1AB Parsnip - babyfood 0.005000 1.000 1.000 FHE 0101314000 1AB Radish, roots 0.005000 1.000 1.000 FHE 0101316000 1AB Radish, Oriental, roots 0.005000 1.000 1.000 FHE 0101327000 1AB Rutabaga 0.005000 1.000 1.000 FHE 0101331000 1AB Salsify, roots 0.005000 1.000 1.000 FHE 0101388000 1AB Turnip, roots 0.005000 1.000 1.000 FHE 0103015000 1CD Arrowroot, flour 0.025000 1.000 1.000 0103015001 1CD Arrowroot, flour - babyfood 0.025000 1.000 1.000 0103017000 1CD Artichoke, Jerusa lem 0.025000 1.000 1.000 0103082000 1CD Cassava 0.025000 1.000 1.000 0103082001 1CD Cassava - babyfood 0.025000 1.000 1.000 0103139000 1CD Dasheen, corm 0.02500 0 1.000 1.000 0103166000 1CD Ginger 0.025000 1.000 1.000 0103166001 1CD Ginger - babyfood 0.025000 1.000 1.000 0103167000 1CD Ginger, dried 0.025000 1.000 1.000 010329 6000 1C Potato, chips 0.025000 1.000 0.025 0103297000 1C Potato, dry (granules/ flakes) 0.025000 6.500 0.025 0103297001 1C Potato, dry (granules/ flakes) - b 0.025000 6.500 0.025 0103298000 1C Potato, flour 0.025000 6.500 0.025 0103298001 1C Potato, flour - babyfood 0.025000 6.500 0.025 0103299000 1C Potato, tuber, w/peel 0.025000 1.000 0.025 0103299001 1C Potato, tuber, w/peel - babyfood 0.025 000 1.000 0.025 0103300000 1C Potato, tuber, w/o peel 0.025000 1.000 0.025 0103300001 1C Potato, tuber, w/o peel - babyfood 0.025000 1.000 0.025 0103366000 1CD Sweet potato 0.025000 1.000 1.000 0103 366001 1CD Sweet potato - babyfood 0.025000 1.000 1.000 0103371000 1CD Tanier, corm 0.025000 1.000 1.000 0103387000 1CD Turmeric 0.025000 1.000 1.000 0103406000 1CD Yam, true 0.025000 1.000 1.000 0103407000 1CD Yam bean 0.025000 1.000 1.000 0200051000 2 Beet, garden, tops 0.005000 1.000 1.000 FHE 0200101000 2 Chicor y, tops 0.005000 1.000 1.000 FHE 0200140000 2 Dasheen, leaves 0.005000 1.000 1.000 FHE 0200315000 2 Radish, tops 0.005000 1.000 1.000 FHE 0200317000 2 Radish, Oriental, tops 0.005000 1.000 1.000 FHE 0200332000 2 Salsify, tops 0.005000 1.000 1.000 FHE 0301165000 3A Garlic, bulb 0.005000 1.000 1.000 FHE 0301165001 3A Garlic, bulb - babyfood 0.0 05000 1.000 1.000 FHE 0301237000 3A Onion, bulb 0.005000 1.000 1.000 FHE 0301237001 3A Onion, bulb - babyfood 0.005000 1.000 1.000 FHE 0301238000 3A Onion, bulb, dried 0.005000 1.000 1 .000 FHE 0301238001 3A Onion, bulb, dried - babyfood 0.005000 1.000 1.000 FHENovaluron Dietary Exposure & Risk Assessment D426069

Page 18 of 30 0301338000 3A Shallot, bulb 0.005000 1.000 1.000 FHE 0302103000 3B Chive, fresh leaves 0.005000 1.000 1.000 FHE 030219 8000 3B Leek 0.005000 1.000 1.000 FHE 0302239000 3B Onion, green 0.005000 1.000 1.000 FHE 0302338500 3B Shallot, fresh leaves 0.005000 1.000 1.000 FHE 0401005000 4A Amaran th, leafy 0.005000 1.000 1.000 FHE 0401018000 4A Arugula 0.005000 1.000 1.000 FHE 0401104000 4A Chrysanthemum, garland 0.005000 1.000 1.000 FHE 0401133000 4A Cress, garden 0.005000 1.000 1.000 FHE 0401134000 4A Cress, upland 0.005000 1.000 1.000 FHE 0401138000 4A Dandelion, leaves 0.005000 1.000 1.000 FHE 0401150000 4A Endive 0.0 05000 1.000 1.000 FHE 0401204000 4A Lettuce, head 0.005000 1.000 1.000 FHE 0401205000 4A Lettuce, leaf 0.005000 1.000 1.000 FHE 0401248000 4A Parsley, leaves 0.005000 1.000 1 .000 FHE 0401313000 4A Radicchio 0.005000 1.000 1.000 FHE 0401355000 4A Spinach 0.005000 1.000 1.000 FHE 0401355001 4A Spinach - babyfood 0.005000 1.000 1.000 FHE 0402076000 4B Cardoon 0.005000 1.000 1.000 FHE 0402085000 4B Celery 0.005000 1.000 1.000 FHE 0402085001 4B Celery - babyfood 0.005000 1.000 1.000 FHE 0402086000 4B Celery, juice 0.005000 1.000 1.000 FHE 0402087000 4B Celtuce 0.005000 1.000 1.000 FHE 0402152000 4B Fennel, Florence 0.005000 1.000 1.000 FHE 0402322000 4B Rhubarb 0.005000 1.000 1.000 FHE 0402367000 4B Swiss chard 4.200000 1.000 1.000 0501061000 5A Broccoli 0.106000 1.000 1.000 0501061001 5A Broccoli - babyfood 0.1 06000 1.000 1.000 0501062000 5A Broccoli, Chinese 0.106000 1.000 1.000 0501064000 5A Brussels sprouts 0.051000 1.000 1.000 0501069000 5A Cabbage 0.051000 1.000 0.050 05 01071000 5A Cabbage, Chinese, napa 0.051000 1.000 1.000 0501072000 5A Cabbage, Chinese, mustard 0.106000 1.000 1.000 0501083000 5A Cauliflower 0.106000 1.000 0.025 0501196000 5A Kohlrabi 0.051000 1.000 1.000 0502063000 5B Broccoli raab 5.330000 1.000 1.000 0502070000 5B Cabbage, Chinese, bok choy 5.330000 1.000 1.000 0502117000 5B Collards 5 .330000 1.000 1.000 0502194000 5B Kale 5.330000 1.000 1.000 0502229000 5B Mustard greens 5.330000 1.000 1.000 0502318000 5B Rape greens 5.330000 1.000 1.000 0502389000 5B Turnip, greens 5.330000 1.000 1.000 0600347000 6 Soybean, seed 0.070000 1.000 1.000 0600349000 6 Soybean, soy milk 0.070000 1.000 1.000 0600349001 6 Soybean, soy milk - babyfood or in 0.070000 1.000 1.000 0600350000 6 Soybean, oil 0.070000 1.000 1.000 0600350001 6 Soybean, oil - babyfood 0.070000 1.000 1.000 0601043000 6A Bean, sna p, succulent 0.180000 1.000 1.000 0601043001 6A Bean, snap, succulent - babyfood 0.180000 1.000 1.000 0601257000 6A Pea, edible podded, succulent 0.005000 1.000 1.000 FHE 0601349500 6AB Soybean, vegetable 0.180000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.180000 1.000 1.000 0602033000 6B Bean, cowpea, succulent 0.180000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.050200 1.000 1.0 00 0602255000 6B Pea, succulent 0.005000 1.000 1.000 FHE 0602255001 6B Pea, succulent - babyfood 0.005000 1.000 1.000 FHE 0602259000 6B Pea, pigeon, succulent 0.005000 1.000 1.000 FHE 0603030000 6C Bean, black, seed 0.065000 1.000 0.010 0603032000 6C Bean, broad, seed 0.065000 1.000 0.010 0603034000 6C Bean, cowpea, seed 0.065000 1.000 0.010 0603035000 6C Bean, great norther n, seed 0.065000 1.000 0.010 0603036000 6C Bean, kidney, seed 0.065000 1.000 0.010 0603038000 6C Bean, lima, seed 0.065000 1.000 0.010 0603039000 6C Bean, mung, seed 0.065000 1.000 0.010 0603040000 6C Bean, navy, seed 0.065000 1.000 0.010 0603041000 6C Bean, pink, seed 0.065000 1.000 0.010 0603042000 6C Bean, pinto, seed 0.065000 1.000 0.010 060309800 0 6C Chickpea, seed 0.065000 1.000 0.010 0603098001 6C Chickpea, seed - babyfood 0.065000 1.000 0.010 0603099000 6C Chickpea, flour 0.065000 1.000 0.010Novaluron Dietary Exposure & Risk Assessment D426069

Page 19 of 30 0603182000 6C Guar, seed 0.065000 1.000 0.010 0603182001 6C Guar, seed - babyfood 0.065000 1.000 0.010 0603203000 6C Lentil, seed 0.005000 1.000 1.000 FHE 0603256000 6C Pea, dry 0.005000 1.000 1.000 FHE 0603256001 6C Pea, dry - babyfood 0.005000 1.000 1.000 FHE 0603258000 6C Pea, pigeon, seed 0.005000 1.000 1.000 FHE 0603348000 6C Soybean, flour 0.070000 1.000 1.000 0603348001 6C Soybean, flour - babyfood 0.070000 1.000 1.000 0801374000 8A Tomatillo 0.161000 1.000 1.000 0801375000 8A Tomato 0.161000 1.000 0.025 0801375001 8A Tomato - babyfood 0.161000 1.000 0.025 0801376000 8A Tomato, paste 0.161000 1.100 0.025 0801376001 8A Tomato, paste - babyfood 0.161000 1.100 0.025 0801377000 8A Tomato, puree 0.161000 0.700 0.025 0801377001 8A Tomato, puree - babyfood 0.161000 0.700 0.025 0801378000 8A Tomato, dried 0.161000 14.300 0.025 0801378001 8A Tomato, dried - babyfood 0.161000 14.3 00 0.025 0801379000 8A Tomato, juice 0.161000 1.500 0.025 0801380000 8A Tomato, Tree 0.161000 1.000 1.000 0802148000 8BC Eggplant 0.140000 1.000 1.000 0802234000 8B C Okra 0.160000 1.000 1.000 0802270000 8B Pepper, bell 0.140000 1.000 0.025 0802270001 8B Pepper, bell - babyfood 0.140000 1.000 0.025 0802271000 8B Pepper, bell, dried 0.140000 1.000 0.025 0802271001 8B Pepper, bell, dried - babyfood 0.140000 1.000 0.025 0802272000 8BC Pepper, nonbell 0.160000 1.000 0.025 0802272001 8BC Pepper, nonbell - babyfood 0.160000 1 .000 0.025 0802273000 8BC Pepper, nonbell, dried 0.160000 1.000 0.025 0901075000 9A Cantaloupe 0.055000 1.000 1.000 0901187000 9A Honeydew melon 0.055000 1.000 1.000 0901399000 9A Watermelon 0.055000 1.000 1.000 0901400000 9A Watermelon, juice 0.055000 1.000 1.000 0902021000 9B Balsam pear 0.054200 1.000 1.000 0902088000 9B Chayote, fruit 0.044000 1.000 1.000 0902102000 9B Chinese waxgourd 0.054200 1.000 1.000 0902135000 9B Cucumber 0.054200 1.000 1.000 0902308000 9B Pumpkin 0.044000 1.000 1.000 0902309000 9B Pumpkin, seed 0.044000 1.000 1.000 0902356000 9B Squash, summer 0.044000 1.000 1.000 0902356001 9B Squash, summer - babyfood 0.044000 1.000 1.000 0902357000 9B Squash, winter 0.044000 1.000 1.000 0902357001 9B Squash, winter - babyfood 0.044000 1.000 1.000 1001106000 10A Citron 0.005000 1.000 1.000 FHE 1001107000 10A Citrus hybrids 0.005000 1.000 1.000 FHE 1001108000 10A Citrus, oil 0.005000 1.000 1.000 FHE 1001240000 10A Orange 0.005000 1.000 1.000 FHE 1001241000 10A Orange, juice 0.005000 1.000 1.000 FHE 1001241001 10A Orange, juice - babyfood 0.005000 1.000 1.000 FHE 1001242000 10A Orange, peel 0.005000 1.000 1.000 FHE 1001369000 10A Tangerine 0.005000 1.000 1.000 FHE 1001370000 10A Tangerine, juice 0.005000 1.000 1.000 FHE 1002197000 10B Kumquat 0.005000 1.000 1.000 FHE 1002199000 10B Lemon 0.005000 1.000 1.000 FHE 1002200000 10B Lemon, juice 0.005000 1.000 1.000 FHE 1002200001 10B Lemon, juice - babyfood 0.005000 1.000 1.000 FHE 1002201000 10B Lemon, peel 0.005000 1.000 1.000 FHE 1002206000 10B Lime 0.005000 1.000 1.000 FHE 1002207000 10B Lime, juice 0.005000 1.000 1.000 FHE 1002207001 10B Lime, juice - babyfood 0.005000 1.000 1.000 FHE 1003180000 10C Grapefruit 0.005000 1.000 1.000 FHE 1003181000 10C Grapefruit, juice 0.005000 1.000 1.000 FHE 1003307000 10C Pummelo 0.005000 1.000 1.000 FHE 1100007000 11 Apple, fruit with peel 0.578000 1.000 0.100 1100008000 11 Apple, peeled fruit 0.578000 1.000 0.100 1100008001 11 Apple, peeled fruit - babyfood 0.578000 1.000 0.100 1100009000 11 Apple, dr ied 0.578000 8.000 0.100 1100009001 11 Apple, dried - babyfood 0.578000 8.000 0.100 1100010000 11 Apple, juice 0.578000 0.100 0.100 1100010001 11 Apple, juice - babyfood 0.578000 0.100 0.100 1100011000 11 Apple, sauce 0.578000 1.000 0.100Novaluron Dietary Exposure & Risk Assessment D426069

Page 20 of 30 1100011001 11 Apple, sauce - babyfood 0.578000 1.000 0.100 1100129000 11 Crabapple 0.578000 1.000 1.000 1100173500 11 Goji berry 0.161000 1.000 1.000 1100210000 11 Loquat 0.833000 1.000 1.000 1100266000 11 Pear 0.833000 1.000 0.150 1100266001 11 Pear - ba byfood 0.833000 1.000 0.150 1100267000 11 Pear, dried 0.833000 6.250 0.150 1100268000 11 Pear, juice 0.833000 0.100 0.150 1100268001 11 Pear, juice - babyfood 0.833000 0.100 0.150 1100310000 11 Quince 0.833000 1.000 1.000 1201090000 12A Cherry 2.170000 1.000 1.000 1201090001 12A Cherry - babyfood 2.170000 1.000 1.00 0 1201091000 12A Cherry, juice 2.170000 0.100 1.000 1201091001 12A Cherry, juice - babyfood 2.170000 0.100 1.000 1202012000 12B Apricot 0.610000 1.000 1.000 1202012001 12B Apric ot - babyfood 0.610000 1.000 1.000 1202013000 12B Apricot, dried 0.610000 6.000 1.000 1202014000 12B Apricot, juice 0.610000 0.100 1.000 1202014001 12B Apricot, juice - babyfood 0.610000 0.100 1.000 1202230000 12B Nectarine 0.610000 1.000 1.000 1202260000 12B Peach 0.610000 1.000 1.000 1202260001 12B Peach - babyfood 0.610000 1.000 1.000 1202261000 12B Peach, dried 0.610000 7.000 1.000 1202261001 12B Peach, dried - babyfood 0.610000 7.000 1.000 1202262000 12B Peach, ju ice 0.610000 0.100 1.000 1202262001 12B Peach, juice - babyfood 0.610000 0.100 1.000 1203285000 12C Plum 0.403000 1.000 1.000 1203285001 12C Plum - babyfood 0.403000 1.000 1.000 1203286000 12C Plum, prune, fresh 0.403000 1.000 1.000 1203286001 12C Plum, prune, fresh - babyfood 0.403000 1.000 1.000 1203287000 12C Plum, prune, dried 1.370000 1.000 1.000 1203287001 12C Plum, prune, dried - babyfood 1.370000 1.000 1.000 1203288000 12C Plum, prune, juice 1.370000 0.100 1.000 1203288001 12C Plum, prune, juice - babyfood 1.370000 0.100 1.000 1301055000 13A Blackbe rry 0.005000 1.000 1.000 FHE 1301056000 13A Blackberry, juice 0.005000 1.000 1.000 FHE 1301056001 13A Blackberry, juice - babyfood 0.005000 1.000 1.000 FHE 1301058000 13A Boysenberry 0.005000 1.000 1.000 FHE 1301208000 13A Loganberry 0.005000 1.000 1.000 FHE 1301320000 13A Raspberry 0.005000 1.000 1.000 FHE 1301320001 13A Raspberry - babyfood 0.00 5000 1.000 1.000 FHE 1301321000 13A Raspberry, juice 0.005000 1.000 1.000 FHE 1301321001 13A Raspberry, juice - babyfood 0.005000 1.000 1.000 FHE 1302057000 13B Blueberry 1.970000 1.000 0. 010 1302057001 13B Blueberry - babyfood 1.970000 1.000 0.010 1302136000 13B Currant 1.970000 1.000 1.000 1302137000 13B Currant, dried 1.970000 1.000 1.000 1302149000 13B Eld erberry 1.970000 1.000 1.000 1302174000 13B Gooseberry 1.970000 1.000 1.000 1302191000 13B Huckleberry 1.970000 1.000 1.000 1303227000 13C Mulberry 0.005000 1.000 1.000 FHE 1304175000 13D Grape 0.005000 1.000 1.000 FHE 1304176000 13D Grape, juice 0.005000 1.000 1.000 FHE 1304176001 13D Grape, juice - babyfood 0.005000 1.000 1.000 FHE 1304179000 13D Grape, wine and sherry 0.005000 1.000 1.000 FHE 1304195000 13D Kiwifruit, fuzzy 0.005000 1.000 1.000 FHE 1307130000 13G Cranberry 0.140000 1.000 1.000 1307130001 13G Cranberry - babyfood 0.140000 1.000 1.000 1307131000 13G Cranberry, dried 0.140000 1.000 1.000 1307132000 13G Cranberry, juice 0.140000 1.100 1.000 1307132001 13G Cranberr y, juice - babyfood 0.140000 1.100 1.000 1307359000 13G Strawberry 0.140000 1.000 0.350 1307359001 13G Strawberry - babyfood 0.140000 1.000 0.350 1307360000 13G Strawberry, juice 0.140000 1.000 0.350 1307360001 13G Strawberry, juice - babyfood 0.140000 1.000 0.350 1400003000 14 Almond 0.005000 1.000 1.000 FHE 1400003001 14 Almond - babyfood 0.005000 1.000 1. 000 FHE 1400004000 14 Almond, oil 0.005000 1.000 1.000 FHE 1400004001 14 Almond, oil - babyfood 0.005000 1.000 1.000 FHE 1400059000 14 Brazil nut 0.005000 1.000 1.000 FHENovaluron Dietary Exposure & Risk Assessment D426069

Page 21 of 30 1400068 000 14 Butternut 0.005000 1.000 1.000 FHE 1400081000 14 Cashew 0.005000 1.000 1.000 FHE 1400092000 14 Chestnut 0.005000 1.000 1.000 FHE 1400155000 14 Hazelnu t 0.005000 1.000 1.000 FHE 1400156000 14 Hazelnut, oil 0.005000 1.000 1.000 FHE 1400185000 14 Hickory nut 0.005000 1.000 1.000 FHE 1400213000 14 Macadamia nut 0.005000 1.000 1.000 FHE 1400269000 14 Pecan 0.005000 1.000 1.000 FHE 1400278000 14 Pine nut 0.005000 1.000 1.000 FHE 1400282000 14 Pistachio 0.005000 1.000 1.000 FHE 1400391000 14 Walnut 0.005000 1.000 1.000 FHE 1500025000 15 Barley, pearled barley 0.005000 1.000 1.000 FHE 1500025001 15 Barley, pearled barley - babyfood 0.005000 1.000 1.000 FHE 1500026000 15 Barley, flour 0.005000 1.000 1.000 FHE 1500026001 15 Barley, flour - babyfood 0.005000 1.000 1.000 FHE 1500027000 15 Barley, bran 0.005000 1.000 1.000 FHE 150 0065000 15 Buckwheat 0.005000 1.000 1.000 FHE 1500066000 15 Buckwheat, flour 0.005000 1.000 1.000 FHE 1500120000 15 Corn, field, flour 0.005000 1.000 1.000 FHE 1500120001 15 Cor n, field, flour - babyfood 0.005000 1.000 1.000 FHE 1500121000 15 Corn, field, meal 0.005000 1.000 1.000 FHE 1500121001 15 Corn, field, meal - babyfood 0.005000 1.000 1.000 FHE 1500122000 15 Corn, field, bran 0.005000 1.000 1.000 FHE 1500123000 15 Corn, field, starch 0.005000 1.000 1.000 FHE 1500123001 15 Corn, field, starch - babyfood 0.005000 1.000 1.000 FHE 1500124000 15 Corn, field, syrup 0.005000 1.000 1.000 FHE 1500124001 15 Corn, field, syrup - babyfood 0.005000 1.000 1.000 FHE 1500125000 15 Corn, field, oil 0.005000 1.000 1.000 FHE 1500125001 15 Corn, field, oil - babyfood 0.005000 1.000 1.000 FHE 1500126000 15 Corn, pop 0.005000 1.000 1.000 FHE 1500127000 15 Corn, sweet 0.025000 1.000 0.360 1500127001 15 Corn, sweet - babyfood 0.025000 1.000 0.360 150022600 0 15 Millet, grain 0.005000 1.000 1.000 FHE 1500231000 15 Oat, bran 0.005000 1.000 1.000 FHE 1500232000 15 Oat, flour 0.005000 1.000 1.000 FHE 1500232001 15 Oat, flou r - babyfood 0.005000 1.000 1.000 FHE 1500233000 15 Oat, groats/rolled oats 0.005000 1.000 1.000 FHE 1500233001 15 Oat, groats/rolled oats - babyfood 0.005000 1.000 1.000 FHE 1500323000 15 Rice, white 0.005000 1.000 1.000 FHE 1500323001 15 Rice, white - babyfood 0.005000 1.000 1.000 FHE 1500324000 15 Rice, brown 0.005000 1.000 1.000 FHE 1500324001 15 Rice, brown - babyfood 0.0050 00 1.000 1.000 FHE 1500325000 15 Rice, flour 0.005000 1.000 1.000 FHE 1500325001 15 Rice, flour - babyfood 0.005000 1.000 1.000 FHE 1500326000 15 Rice, bran 0.005000 1.000 1.00 0 FHE 1500326001 15 Rice, bran - babyfood 0.005000 1.000 1.000 FHE 1500328000 15 Rye, grain 0.005000 1.000 1.000 FHE 1500329000 15 Rye, flour 0.005000 1.000 1.000 FHE 150034400 0 15 Sorghum, grain 1.230000 1.000 0.020 1500345000 15 Sorghum, syrup 0.005000 1.000 1.000 FHE 1500381000 15 Triticale, flour 0.005000 1.000 1.000 FHE 1500381001 15 Triticale, f lour - babyfood 0.005000 1.000 1.000 FHE 1500401000 15 Wheat, grain 0.005000 1.000 1.000 FHE 1500401001 15 Wheat, grain - babyfood 0.005000 1.000 1.000 FHE 1500402000 15 Wheat, flour 0.005000 1.000 1.000 FHE 1500402001 15 Wheat, flour - babyfood 0.005000 1.000 1.000 FHE 1500403000 15 Wheat, germ 0.005000 1.000 1.000 FHE 1500404000 15 Wheat, bran 0.005000 1.000 1.000 FHE 1500405000 15 Wild rice 0.005000 1.000 1.000 FHE 1800002000 18 Alfalfa, seed 0.005000 1.000 1.000 FHE 1901028000 19A Basil, fresh leaves 0.005000 1.000 1.000 FHE 1901028001 19A Basil, fresh leaves - babyfood 0.005000 1.000 1.000 FHE 1901029000 19A Basil, dried leaves 0.005000 1.000 1.000 FHE 1901029001 19A Basil, dried leaves - babyfood 0.005000 1.000 1.000 FHE 1901102500 1 9A Chive, dried leaves 0.005000 1.000 1.000 FHE 1901118000 19A Cilantro, leaves 0.005000 1.000 1.000 FHE 1901118001 19A Cilantro, leaves - babyfood 0.005000 1.000 1.000 FHE 1901144000 19A Dillweed 0.005000 1.000 1.000 FHE 1901184000 19A Herbs, other 0.005000 1.000 1.000 FHE 1901184001 19A Herbs, other - babyfood 0.005000 1.000 1.000 FHENovaluron Dietary Exposure & Risk Assessment D426069

Page 22 of 30 1901202000 19A Lemongrass 0.005000 1.000 1.000 FHE 1901220000 19A Marjoram 0.005000 1.000 1.000 FHE 1901220001 19A Marjoram - babyfood 0.005000 1.000 1.000 FHE 1901249000 19A Parsley, dried leaves 0.005000 1.000 1.000 FHE 1901249001 19A Parsley, dried leaves - babyfood 0.005000 1.000 1.000 FHE 1901334000 19A Savory 0.005000 1.000 1.000 FHE 1902105000 19B Cinnamon 0.005000 1.000 1.000 FHE 1902105001 19B Cinnamon - babyfood 0.005000 1.000 1.000 FHE 1902119000 19B Coriander, seed 0.005000 1.000 1.000 FHE 1902119001 19B Coriander, seed - babyfood 0.005000 1.000 1.000 FHE 1902143000 1 9B Dill, seed 0.005000 1.000 1.000 FHE 1902274000 19B Pepper, black and white 0.005000 1.000 1.000 FHE 1902274001 19B Pepper, black and white - babyfood 0.005000 1.000 1.000 FHE 1902354000 19B Spices, othe r 0.005000 1.000 1.000 FHE 1902354001 19B Spices, other - babyfood 0.005000 1.000 1.000 FHE 2001163000 20A Flax seed, oil 0.005000 1.000 1.000 FHE 2001319000 20A Rapeseed, oil 0.005000 1.000 1.000 FHE 2001319001 20A Rapeseed, oil - babyfood 0.005000 1.000 1.000 FHE 2001336000 20A Sesame, seed 0.005000 1.000 1.000 FHE 2001336001 20A Sesame, seed - babyfood 0.005000 1.000 1.000 FHE 2001337000 20A Sesame, oil 0.005000 1.000 1.000 FHE 2001337001 20A Sesame, oil - babyfood 0.005000 1.000 1.000 FHE 2002330000 20B Safflower, oil 0.005000 1.000 1.000 FHE 2002330001 20B Safflower, oil - babyfood 0.005000 1.000 1.000 FHE 2002364000 20B Sunflower, seed 0.005000 1.000 1.000 FHE 2002365000 20B Sunflower, oil 0.005000 1.000 1.000 FHE 2002365001 20B Sunflower, oil - babyfood 0.005000 1.000 1.000 FHE 2003114001 20C Coconut, oil - babyfood 0.005000 1.000 1.000 FHE 2003128000 20C Cottonseed, oil 0.115000 0.600 0.025 2003128001 20C Cottonseed, oi l - babyfood 0.115000 0.600 0.025 2100228000 21 Mushroom 0.005000 1.000 1.000 FHE 3100044000 31 Beef, meat 0.047000 1.000 1.000 3100044001 31 Beef, meat - babyfood 0 .047000 1.000 1.000 3100045000 31 Beef, meat, dried 0.047000 1.920 1.000 3100046000 31 Beef, meat byproducts 1.040000 1.000 1.000 3100046001 31 Beef, meat byproducts - babyfood 1.040000 1.000 1.000 3100047000 31 Beef, fat 1.040000 1.000 1.000 3100047001 31 Beef, fat - babyfood 1.040000 1.000 1.000 3100048000 31 Beef, kidney 0.057000 1.000 1.000 3100049000 31 Beef, liv er 0.062000 1.000 1.000 3100049001 31 Beef, liver - babyfood 0.062000 1.000 1.000 3200169000 32 Goat, meat 0.047000 1.000 1.000 3200170000 32 Goat, meat byproducts 1.040000 1.000 1.000 3200171000 32 Goat, fat 1.040000 1.000 1.000 3200172000 32 Goat, kidney 0.057000 1.000 1.000 3200173000 32 Goat, liver 0.062000 1.000 1.000 3300189000 33 Horse, meat 0.047000 1.000 1.000 3400290000 34 Pork, meat 0.000500 1.000 1.000 3400290001 34 Pork, meat - babyfood 0.000500 1.000 1.000 3400291000 34 Pork, s kin 0.011000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.011000 1.000 1.000 3400292001 34 Pork, meat byproducts - babyfood 0.011000 1.000 1.000 3400293000 34 Pork, fat 0.011000 1.000 1.000 3400293001 34 Pork, fat - babyfood 0.011000 1.000 1.000 3400294000 34 Pork, kidney 0.000610 1.000 1.000 3400295000 34 Pork, liver 0.000670 1.000 1.000 3500339000 35 Sheep, meat 0.047000 1.000 1.000 3500339001 35 Sheep, meat - babyfood 0.047000 1.000 1.000 3500340000 35 Sheep, me at byproducts 1.040000 1.000 1.000 3500341000 35 Sheep, fat 1.040000 1.000 1.000 3500341001 35 Sheep, fat - babyfood 1.040000 1.000 1.000 3500342000 35 Sheep, kidney 0.057000 1.000 1.000 3500343000 35 Sheep, liver 0.062000 1.000 1.000 3600222000 36 Milk, fat 1.960000 1.000 1.000 3600222001 36 Milk, fat - baby food/infant formu 1.960000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.078000 1.000 1.000 3600223001 36 Milk, nonfat solids - baby food/in 0.078000 1.000 1.000 3600224000 36 Milk, water 0.005000 1.000 1.000 FHE; a

Full comment: FHE; all res in milk assumed assoc w/fats & solids 3600224001 36 Milk, water - babyfood/infant form 0.005000 1.000 1.000 FHE; aNovaluron Dietary Exposure & Risk Assessment D426069

Page 23 of 30 Full comment: FHE; all res in milk assumed assoc w/fats & solids 3600225001 36 Milk, sugar (lactose ) - baby food/ 0.005000 1.000 1.000 FHE; a

Full comment: FHE; all res in milk assumed assoc w/fats & solids 3800221000 38 Meat, game 0.047000 1.000 1.000 3900312000 39 Rabbit, meat 0.04 7000 1.000 1.000 4000093000 40 Chicken, meat 0.002500 1.000 1.000 4000093001 40 Chicken, meat - babyfood 0.002500 1.000 1.000 4000094000 40 Chicken, liver 0.006300 1.000 1.000 400 0095000 40 Chicken, meat byproducts 0.059000 1.000 1.000 4000095001 40 Chicken, meat byproducts - babyfoo 0.059000 1.000 1.000 4000096000 40 Chicken, fat 0.059000 1.000 1.000 4000096001 40 Chicken, fat - babyfood 0.059000 1.000 1.000 4000097000 40 Chicken, skin 0.059000 1.000 1.000 4000097001 40 Chicken, skin - babyfood 0.059000 1.000 1.000 5000382000 50 Turkey, meat 0.002500 1.000 1.000 5000382001 50 Turkey, meat - babyfood 0.002500 1.000 1.000 5000383000 50 Turkey, liver 0.006300 1.000 1.000 5000383001 50 Turkey, l iver - babyfood 0.006300 1.000 1.000 5000384000 50 Turkey, meat byproducts 0.059000 1.000 1.000 5000384001 50 Turkey, meat byproducts - babyfood 0.059000 1.000 1.000 5000385000 50 Turkey, fat 0.059000 1.000 1.000 5000385001 50 Turkey, fat - babyfood 0.059000 1.000 1.000 5000386000 50 Turkey, skin 0.059000 1.000 1.000 5000386001 50 Turkey, skin - babyfood 0.059000 1.000 1.000 6000301000 60 Poultry, other, meat 0.002500 1.000 1.000 6000302000 60 Poultry, other, liver 0.006300 1.000 1.000 6000303000 60 Poultry, other, meat byproducts 0.059000 1.000 1.000 6000304000 60 Poultry , other, fat 0.059000 1.000 1.000 6000305000 60 Poultry, other, skin 0.059000 1.000 1.000 7000145000 70 Egg, whole 0.012000 1.000 1.000 7000145001 70 Egg, whole - babyfood 0.012000 1.000 1.000 7000146000 70 Egg, white 0.012000 1.000 1.000 7000146001 70 Egg, white (solids) - babyfood 0.012000 1.000 1.000 7000147000 70 Egg, yolk 0.012000 1.000 1.00 0 7000147001 70 Egg, yolk - babyfood 0.012000 1.000 1.000 8000157000 80 Fish - freshwater finfish 0.005000 1.000 1.000 FHE 8000158000 80 Fish - freshwater finfish, farm ra 0.005000 1.000 1.000 FHE 8000159000 80 Fish - saltwater finfish, tuna 0.005000 1.000 1.000 FHE 8000160000 80 Fish - saltwater finfish, other 0.005000 1.000 1.000 FHE 8000161000 80 Fish - shellfish, crustacean 0.005000 1.000 1.000 FHE 8000162000 80 Fish - shellfish, mollusc 0.005000 1.000 1.000 FHE 8601000000 86A Water, direct, all sources 0.077800 1.000 1.000 8602000000 86B Water, indirect, all sources 0.077800 1.000 1.000 9500001000 O Acerola 0.005000 1.000 1.000 FHE 9500001500 O Agave 0.005000 1.000 1.000 FHE 9500006000 O Amaranth, grain 0.005000 1.000 1.000 FHE 9500016000 O Artichoke, globe 0.005000 1.000 1.000 FHE 9500019000 O Asparagus 0.005000 1.000 1.000 FHE 9500019500 O Atemoya 0.005000 1.000 1.000 FHE 9500020000 O Avocado 0.192000 1.000 1.000 950002 2000 O Bamboo, shoots 0.005000 1.000 1.000 FHE 9500023000 O Banana 0.005000 1.000 1.000 FHE 9500023001 O Banana - babyfood 0.005000 1.000 1.000 FHE 9500024000 O Banana , dried 0.005000 1.000 1.000 FHE 9500024001 O Banana, dried - babyfood 0.005000 1.000 1.000 FHE 9500054000 O Belgium endive 0.005000 1.000 1.000 FHE 9500060000 O Breadfruit 0.005000 1.000 1.000 FHE 9500073000 O Cactus 0.005000 1.000 1.000 FHE 9500074000 O Canistel 0.005000 1.000 1.000 FHE 9500077000 O Carob 0.0 05000 1.000 1.000 FHE 9500089000 O Cherimoya 0.005000 1.000 1.000 FHE 9500109000 O Cocoa bean, chocolate 0.005000 1.000 1.000 FHE 9500110000 O Cocoa bean, powder 0.005000 1.000 1 .000 FHE 9500111000 O Coconut, meat 0.005000 1.000 1.000 FHE 9500111001 O Coconut, meat - babyfood 0.005000 1.000 1.000 FHE 9500112000 O Coconut, dried 0.005000 1.000 1.000 FHE 950011 3000 O Coconut, milk 0.005000 1.000 1.000 FHE 9500114000 O Coconut, oil 0.005000 1.000 1.000 FHE 9500115000 O Coffee, roasted bean 0.005000 1.000 1.000 FHE 9500116000 O Coffee , instant 0.005000 1.000 1.000 FHENovaluron Dietary Exposure & Risk Assessment D426069

Page 24 of 30 9500141000 O Date 0.005000 1.000 1.000 FHE 9500151000 O Feijoa 0.005000 1.000 1.000 FHE 9500153000 O Fig 0.005000 1.000 1.000 FHE 9500154000 O Fig, dried 0.005000 1.000 1.000 FHE 9500177000 O Grape, leaves 0.005000 1.000 1.000 FHE 9500178000 O Grape, raisin 0.0 05000 1.000 1.000 FHE 9500183000 O Guava 0.005000 1.000 1.000 FHE 9500183001 O Guava - babyfood 0.005000 1.000 1.000 FHE 9500186000 O Honey 0.005000 1.000 1 .000 FHE 9500186001 O Honey - babyfood 0.005000 1.000 1.000 FHE 9500188000 O Hop 0.005000 1.000 1.000 FHE 9500193000 O Jackfruit 0.005000 1.000 1.000 FHE 950020 9000 O Longan 0.005000 1.000 1.000 FHE 9500211000 O Lychee 0.005000 1.000 1.000 FHE 9500212000 O Lychee, dried 0.005000 1.000 1.000 FHE 9500214000 O Mamey apple 0.005000 1.000 1.000 FHE 9500215000 O Mango 0.005000 1.000 1.000 FHE 9500215001 O Mango - babyfood 0.005000 1.000 1.000 FHE 9500216000 O Mango, dried 0.005000 1.000 1.000 FHE 9500217000 O Mango, juice 0.005000 1.000 1.000 FHE 9500217001 O Mango, juice - babyfood 0.005000 1.000 1.000 FHE 9500218000 O Maple, sugar 0.0 05000 1.000 1.000 FHE 9500219000 O Maple syrup 0.005000 1.000 1.000 FHE 9500235000 O Olive 0.005000 1.000 1.000 FHE 9500236000 O Olive, oil 0.005000 1.000 1 .000 FHE 9500243000 O Palm heart, leaves 0.005000 1.000 1.000 FHE 9500244000 O Palm, oil 0.005000 1.000 1.000 FHE 9500244001 O Palm, oil - babyfood 0.005000 1.000 1.000 FHE 950024 5000 O Papaya 0.005000 1.000 1.000 FHE 9500245001 O Papaya - babyfood 0.005000 1.000 1.000 FHE 9500246000 O Papaya, dried 0.005000 1.000 1.000 FHE 9500247000 O Papaya, juice 0.005000 1.000 1.000 FHE 9500252000 O Passionfruit 0.005000 1.000 1.000 FHE 9500252001 O Passionfruit - babyfood 0.005000 1.000 1.000 FHE 9500253000 O Passionfruit, ju ice 0.005000 1.000 1.000 FHE 9500253001 O Passionfruit, juice - babyfood 0.005000 1.000 1.000 FHE 9500254000 O Pawpaw 0.005000 1.000 1.000 FHE 9500263000 O Peanut 0.010000 1.000 1.000 9500264000 O Peanut, butter 0.010000 1.890 1.000 9500265000 O Peanut, oil 0.010000 1.000 1.000 9500275000 O Peppermint 0.005000 1.000 1.00 0 FHE 9500276000 O Peppermint, oil 0.005000 1.000 1.000 FHE 9500277000 O Persimmon 0.005000 1.000 1.000 FHE 9500279000 O Pineapple 0.005000 1.000 1.000 FHE 950027900 1 O Pineapple - babyfood 0.005000 1.000 1.000 FHE 9500280000 O Pineapple, dried 0.005000 1.000 1.000 FHE 9500281000 O Pineapple, juice 0.005000 1.000 1.000 FHE 9500281001 O Pineapple , juice - babyfood 0.005000 1.000 1.000 FHE 9500283000 O Plantain 0.005000 1.000 1.000 FHE 9500284000 O Plantain, dried 0.005000 1.000 1.000 FHE 9500289000 O Pomegranate 0.005000 1.000 1.000 FHE 9500306000 O Psyllium, seed 0.005000 1.000 1.000 FHE 9500311000 O Quinoa, grain 0.005000 1.000 1.000 FHE 9500333000 O Sapote, Mamey 0.0050 00 1.000 1.000 FHE 9500335000 O Seaweed 0.005000 1.000 1.000 FHE 9500335001 O Seaweed - babyfood 0.005000 1.000 1.000 FHE 9500346000 O Soursop 0.005000 1.000 1.00 0 FHE 9500351000 O Spanish lime 0.005000 1.000 1.000 FHE 9500352000 O Spearmint 0.005000 1.000 1.000 FHE 9500353000 O Spearmint, oil 0.005000 1.000 1.000 FHE 9500358000 O Starfruit 0.005000 1.000 1.000 FHE 9500361000 O Sugar apple 0.005000 1.000 1.000 FHE 9500362000 O Sugarcane, sugar 0.125000 1.000 1.000 9500362001 O Sug arcane, sugar - babyfood 0.125000 1.000 1.000 9500363000 O Sugarcane, molasses 0.125000 1.000 1.000 9500363001 O Sugarcane, molasses - babyfood 0.125000 1.000 1.000 9500368000 O Tamarind 0.005000 1.000 1.000 FHE 9500372000 O Tea, dried 0.005000 1.000 1.000 FHE 9500373000 O Tea, instant 0.005000 1.000 1.000 FHE 9500373500 O Teff, flour 0.005000 1.000 1.000 FHENovaluron Dietary Exposure & Risk Assessment D426069

Page 25 of 30 9500390000 O Vinegar 0.005000 1.000 1.000 FHE 9500397000 O Water chestnut 0.005000 1.000 1.000 FHE 9500398000 O Watercress 0.005000 1.000 1.000 FHENovaluron Dietary Exposure & Risk Assessment D426069

Page 26 of 30 

### Attachment 3: DEEM **- FCID Chronic Results File**  US EPA Ver. 3.16, 03 - 08 - d DEEM - FCID Chronic analysis for NOVALURON NHANES 2003 - 2008 2 - day Residue file name: C: \ Users \ jlangsda \ Documents \ Chemicals \ Novaluron \ 2014 Avocado, Carrot, Bean, Cucumber, and CG Tolerance Expansions \ Dietary Memo \ novaluron_chronic1_Feb 23 2015.R08 Adjustment factor #2 used. Analysis Date 02 - 23 - 2015/09:23:15 Residue file dated: 02 - 23 - 2015/09:22:50 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

-------------------------------------- ------------- ---------------- **Total US Population 0.003071 27.9%**  Hispanic 0.003037 27.6% Non - Hisp - White 0.003064 27.9% Non - Hisp - Black 0.003009 27.4% Non - Hisp - Other 0.003412 31.0% Nursing Infants 0.002603 23.7% Non - Nursing Infants 0.007936 72.1% Female 13+ PREG 0.002744 24.9% Children 1 - 6 0.006410 58.3% Children 7 - 12 0.003525 32.0% Male 13 - 19 0.002458 22.3% Female 13 - 19/ NP 0.002393 21.8% Male 20+ 0.002590 23.5% Female 20+/NP 0.002728 24.8% Seniors 55+ 0.0 02635 24.0% **All Infants 0.006289 57.2%** Female 13 - 50 0.002636 24.0% **Children 1 -**  **2 0.008014 72.9% Children 3**  **- 5 0.005711 51.9%**  **Children 6 -**  **12 0.003746 34.1% Youth 13**  **- 19 0.002424 22.0%**  **Adults 20 -**  **49 0.002659 24.2%**  **Adults 50 -**  **99 0.002671 24.3% Female 13**  **- 49 0.002640 24.0%** 

------------------------------------------------------------------- ------------Novaluron Dietary Exposure & Risk Assessment D426069

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### Attachment 4: **Novaluron (124002) SLUA**  **, Date:**  **18 June 2014**Novaluron Dietary Exposure & Risk Assessment D426069

Page 28 of 30Novaluron Dietary Exposure & Risk Assessment D426069

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### Attachment 5: Update of PCTn: Novaluron (124002) Use on Sorghum and Sweet Corn (C. **Doucoure, et al.**  **, 01 -**  **FE B**  **- 2013)**  The following tables summarize the PCTn recommendations from the BEAD memo, “Update of Percent Crop Treated for New Use (PCTn): Novaluron (124002) Use on Sorghum and Sweet Corn” (C. Doucoure, et al. , 01 - FEB - 2013).” **Table A.5.1. PCTn with Novaluron on Sorghum** **Based on Novaluron not Overtaking Market Leader.** Crop Year PCTn Sorghum 2011 2% Source: USDA NASS, Agricultural Chemical Usage Report, 2011 **Table A.5.2. PCTn with Novaluron on Sweet Corn Based on Market Leaders.** Crop Year PCTn (Avg) PCTn (Max) Sweet Corn 2009 36% 37%

2010 2011 Source: EPA Proprietary Data, 2009 - 2011