Novaluron Di etary Exposure & Risk Assessment DP#: 364235

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 : 0 4 - DEC - 2009 S UBJECT : Novaluron. Chronic Dietary (Food and Drinking Water) Exposure and Risk

Assessment for the Proposed Use s on Vegetable, Fruiting, Group 8; Vegetable, Cucurbit, Group 9; Berry , L ow - growing, Subgroup 13 - 07G; Miscellaneous Fruiting Vegetables; Bean, Snap; Bean, Dry , Seed ; and Swiss Chard . PC Code: 124002 DP Barcode: D364235 Decision No.: 407555 Registration No. : 66222 - 35 - 400 Petition No.: 9E7546 Regulatory Action: Section 3 Registration Risk Assessment Type: Single Chemical/Aggregate 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 (RAB1)/Health Effects Division (HED) (7509P) THROUGH: Donna S. Davis, Chemist

Nancy Dodd, Chem ist Dietary Exposure Science Advisory Council (DESAC) HED (7509P) and George F. Kramer, Ph.D., Branch Senior Chemist RAB1/HED (7509P) TO: Julie L . Van Alstine , Risk Assessor

RAB1/HED (7509P) and Barbara Madden/Laura Nollen (RM 05) Registration Di vision (RD; 7505P)Novaluron Di etary Exposure & Risk Assessment DP#: 364235

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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 2.03) , which uses food consumption data from the U.S. Department of Agriculture’s ( USDA’s ) Continuing Survey s of Food Intakes by Individuals (CSFI I) from 1994 - 1996 and 1998. The analy sis was performed to support Section 3 request s for use of novaluron on the f ruiting vegetable group 8; cucurbit vegetable group 9; low - growing berry subgroup 13 - 07G; miscellaneous fruiting vegetables; snap bean; dry bean seed ; and Swiss c hard . Acute Dietary

(Food and Drinking Water) Exposure Results and Characterization An acut e 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 proposed new use s on the fruiting vegetable group 8 , cucurbit vegetable group 9 , low - growing berry subgroup 13 - 07G , miscellaneous fruiting vegetables , snap bean , dry bean seed , and Swiss Chard ; all established uses ; and drinking water. A partially refined assessment was conducted. Estimated drinking water concentrations (EDWCs) were provided by the Environmental Fat e and Effects Division (EFED). The chronic analy sis assumed 100% crop treated for a ll commodities; 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 ) and tomato paste and purée; and DEEM  ( ver. 7.81) default processing factors for the remaining pr ocessed commodities. Furthermore, anticipated residues (ARs) were used for meat , hog, and milk 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 population subgroups. The chronic dietary exposure results in a risk estimate that is 25 % of the chronic population - adjusted dose (cPAD) for the general U.S. population and 84 % of the cPAD for children 1 - 2 years old, the most highly exposed population subgroup. 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 Di etary Exposure & Risk Assessment DP#: 364235

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### I. Introduction Dietary risk assessment incor

porates 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 populati o 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 concern ed 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/pesticides w eb 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.pdf

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

risk assessment for novaluron was conducted by J. Van Alstine ( 09 - SEP 2009 , D P# 359460 ). II. Food Residue Information Novaluron Use: Novaluron tolerances are published in 40 CFR§180.598. Residu es 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 As sessments: 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 degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only novaluron ( N - [[[3 - chloro - 4 - [1,1,2 - trifluoro - 2 - (trifluoromethoxy

)ethoxy]phenyl]amino]carbonyl] - 2,6 - difluorobenzamide ) i n or on the following raw agricultural commodities (Memo, J. L. Van Alstine , 04 - DEC - 09; D P # 364237 ) :Novaluron Di etary Exposure & Risk Assessment DP#: 364235

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Page 4 of 15 Vegetable, cucurbit, group 9 0.15 ppm Okra 1.0 ppm Vegetable, fruiting, group 8 1.0 ppm Roselle 1.0 ppm Cocona 1.0 ppm Sunberry 1.0 ppm Eggplant, African 1.0 ppm Tomato, bush 1.0 ppm Eggplant, pea 1.0 ppm Tomato, currant 1.0 ppm Eggplant, scarlet 1.0 ppm Tomato, tree 1.0 ppm Goji berry 1.0 ppm Berry, low - growing, subgroup 13 - 07G 0.45 ppm Huckleberry, garden 1.0 ppm Bean, snap, succ ulent 0.60 ppm Martynia 1.0 ppm Bean, dry, seed 0.30 ppm Naranjilla 1.0 ppm Swiss chard 12 ppm 

### Residues used in the Chronic Analysis (see Attachments 1 and 2) : The current chronic dietary analy sis assumed 100% crop treated for all commodities and was refined through the use of empirical processing factors, 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, hog, and milk commodities . Empirical processing factors for apple juice were translated to pear and other pome fruit juice and all stone fruit j uice . 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). The following fruit ing vegetables are not listed in DEEM - FCID TM 

### and were therefore not included in the chronic assessment: cocona, African eggplant, pea eggplant, scarlet eggplant, goji berry , garden huckleberry , marty nia, naranjilla, roselle, sunberry , bush tomato, and currant tomato. However, tree tomato is includ ed in DEEM and was therefore included in the chronic assessment. III. Drinking Water Data The drinking water residues used in the dietary risk assessment were provided 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), Low growing Berry

Subgroup (13 - 07G), Snap and Dry Bean, and Swiss Chard ” (I . Mahe r, 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 th e proposed uses. Monitoring data are not available for novaluron or its chlorophenyl urea and chloroaniline degradates . Concentrations in surface water and ground water were estimated using modeling. Novaluron: EFED used Tier 2 Pesticide Root Zone Model/Exposure Analy sis Modeling Sy stem (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 inNovaluron Di etary Exposure & Risk Assessment DP#: 364235

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### surface water . For groundwater, the Scre ening 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 drinking water from shallow ground water sources. Chlorophenyl urea and chloroaniline degrada tes: A Tier 1 drinking water analy sis was performed using the FQPA Index Reservoir Screening Tool (FIRST) model to obtain surface water estimates for the chlorophenyl urea and chloroaniline degradates. For surface water, the annual average EDWC for the c hlorophenyl 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 < 0.0 0 45 ppb , and for the chloroaniline 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 chronic 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 EDW C value for chloroaniline (2.6 ppb) was used to assess chronic aggregate risk for this dietary assessment . IV . Percent Crop Treated For all commodities in the chronic assessment, the assumption of 100% crop treated was made. V. DEEM - FCIDTM Program an d Consumption Information A novaluron chronic dietary exposure assessment was conducted using DEEM - FCIDTM, Version 2.03 which incorporates consumption data from USDA’s CSFI I, 1994 - 1996 and 1998. The 1994 - 96 and 1998 data are based on the reported consumpt ion 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, 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 po pulation subgroups: the general U.S. population, all infants (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ years old. For chronic dietary

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

consumption estimate for that food/food form to prod uce a residue intake estimate. The resulting residue intake estimate f or 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 theNovaluron Di etary Exposure & Risk Assessment DP#: 364235

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### 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 de velopmental 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 asse ssment 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 1 is a summary of the decisions made by the HIARC concerning dietary exposure assessment . These endpoints have been confirmed by

the risk assessment team as appropriate for the current risk assessment . Table 1 . 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 UF A = 10 X

UF H = 10 X FQ PA 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 (oral, dermal, inhalati on) 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 adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation i n 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 chro nic assessment, HED is concerned when dietary risk exceeds 100% of the cPAD. The chronic analy sis was performed using DEEM - FCID  (ver. 2.03). The DEEM FCID  analy sis estimates the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 2 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 . The resulting food and drinking water exposure estimates were not ofNovaluron Di etary Exposure & Risk Assessment DP#: 364235

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### concern to HED (  100% cPAD) . The chronic dietary exposure estimates are 25% of the chronic population - adjusted dose (cPAD) for the general U.S. population and 84% of the cPAD for children 1 - 2 years old, the most highly exposed population subgroup (see Attachment 3 for details). Table 2 . 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 0.002749 25

N/A N/A All Infants (< 1 year old) 0.004732 43 Children 1 - 2 years old 0.009204 84 Children 3 - 5 years old 0.007142 65 Children 6 - 12 years old 0.004307 39 Youth 13 - 19 years old 0.002365 22 Adults 20 - 49 years old 0.001944 18 Adults 50+ years old 0.001965 18 Females 13 - 49 years old 0.001856 17 

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

assessment was refi ned through the use of empirical processing factors, 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 be an, dry bean seed, and Swiss chard), average greenhouse trial residues for tomatoes, and ARs for meat, hog, and milk commodities . Empirical processing factors for apple juice were translated to pear and other pome fruit juice and all stone fruit juice. 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 (see 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 harvest ] and assumed 100% crop treated . The current chronic analy sis could be further refined through the following: use of percent crop treated data ; monitoring data; preparation/cooking factors; and/or ARs for poultry commodities. IX . Conclusions A chronic dietary

risk assessment was conducted using DEEM - FCID  (ver. 2.03) . For this assessment, average field trial residues for bell pepper, non - bell pepper, cucumber, summer squash, cantaloupe, strawberry , succulent snap bean, dry bean seed, and Swiss chard were added to the last dietary

assessment. The last dietary assessment in corporated empirical processing factors, average field trial residues (pome fruit, sugarcane, bushberries, Brassica leafy greens, and stone fruit ), average greenhouse trial residue s (tomatoes), and ARs for meat and milk commodities. 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 exposureNovaluron Di etary Exposure & Risk Assessment DP#: 364235

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### estimates ar e 25 % of the cPAD for the general U.S. population and 84 % of the cPAD for children 1 - 2 years old, the most highly exposed population subgroup. X . List of Attachments Attachment 1: AR Table. Attachment 2: DEEM - FCID  Chronic Residue Input File . Attachment 3: DEEM - FCID  Chronic Results File.



### cc: Julie L. Van Alstine J .L . Van Alstine :S - 10954:PY - S:(703)603 - 8866:7509P:RAB1Novaluron Di etary Exposure & Risk Assessment DP#: 364235 PC Code: 124002

Page 9 of 15 Attachm ent 1: Processing Factors and Residue Estim ates fromPrevious Novaluron Dietary Assessm ents (Mem o, G. Kram er, 22 - MAR- 2004, D P# 298783; Mem o, J. Van Alstine, 09 - SEP - 2009, D P# 359460 ) Updated to Include Proposed Com mo dity Processing Factors and Residue Estim ates. crop com modity processing factor 1 residue

(ppm) 1 com me nt meat2 meat 1 0.112 AR dried beef meat dried meat 1.92 0.112 AR; DEEM ( ver. 7.78) default proc. fact. fat 2 fat 1 2.43 AR liver2 liver 1 0.190 AR kidney

2 kidney 1 0.183 AR milk Milk, fat 1 2.82 AR, calculated assuming residues partition into fat Milk, nonfat solids 1 0.113 AR for whole milk, used to account for low residues observed in skim milk Milk, water 1 0 All residues assumed to be associated with fat and solids. Milk, sugar 1 0 All residues assumed to be associated with fat and solids. pork meat meat 1 0.0024 AR pork skin skin 1 0.053 AR (fat) pork fat fat 1 0.053 AR pork liver liver 1 0.0040 AR pork kidney kidney 1 0.0041 AR cotton cottonseed oil 1 0.60 t olerance for RAC adequate to cover residues in processed commodity tuberous and corm vegetables All 1 0.025 1⁄2 LOQ residue; DEEM ( ver. 7.78) default proc. factor of 6.5 used for potato, dry pome fruit

– apple, crabapple 3 RAC, sauce 1 0.578 average field trial residue dried 8 0.578 average field trial residue; DEEM ( ver. 7.78) default proc. fact. juice 0.10 0.5 78 average field trial residue; empirical proc. fact. pome fruit

– pear + other pome fruit 3 RAC 1 0.833 average field trial residue dried 6.25 0.833 average field trial residue; DEEM ( ver. 7.78) default proc. fact. juice 0.10 0.833 average field trial residue; empirical apple proc. fact. s ugarcane sugar 1 0.125 average field trial residue molasses 1 0.125 average field trial residue t omato , tomatillo, tree tomato 4 RAC 1 0.161 overall (small - & large - fruit varieties) average of the greenhouse trial residue. dried 14.3 0.161 overall average of the greenhouse trial residue; DEEM ( ver. 7.78) default proc. fact. juice 1.5 0.161 overall average of the greenhouse trial residue; DEEM ( ver. 7.78) default proc. fact. purée 0.7 0.161 overall average of the greenhouse trial residue; empirical proc. fact. paste 1.1 0.161 overall average of the greenhouse trial residue; empirical proc. fact. bell pepper, eggplant 5 RAC 1 0.14 average bell pepper field trial residue non - bell pepper, okra 6 RAC 1 0.16 averag e non - bell pepper field trial residue Brassica , l eafy greens, s ubgroup 5B and turnip, greens All 1 5.33 average mustard green field trial residue plum RAC 1 0.403 average plum field trial residue dried 1 2.6 tolerance for dried plum juice 0.10 0.403 average plum field trial residue; empirical apple proc. fact.Novaluron Di etary Exposure & Risk Assessment DP#: 364235 PC Code: 124002

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crop com modity processing factor 1 residue

(ppm) 1 com me nt cherry RAC 1 2.17 average field trial residue juice 0.10 2.17 average field trial residue ; empirical apple proc. fact. peach, nectarine, and apricot4 RAC 1 0.61 average peach field trial re sidue dried 7.0 0.61 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 juice 0.10 0.61 average peach field trial residue; empirical apple proc. fact. cucumber, Chine se waxgourd, balsam pear 8 All 1 0.05 average cucumber field trial residue cantaloupe, casaba , honeydew melon, winter melon, watermelon 9 RAC 1 0.055 average cantaloupe field trial residue juice 1 0.055 average cantaloupe field trial residue summer squas h, chayote fruit Christophe , pumpkin, winter squash 10 All 1 0.044 average summer squash field trial residue bushberry s ubgroup 13 - 07B 11 All 1 1.97 average blueberry field trial residue low - growing berry subgroup 13 - 07G 12 All 1 0.140 average strawberry fi eld trial residue; DEEM ( ver. 7.78) default proc. fact. of 1.1 used for cranberry juice snap bean (succulent) All 1 0.18 average succulent snap bean pods with seeds field trial residue dry bean seed All 1 0.065 average dry bean seed field trial residue Swiss chard All 1 4.2 average Swiss chard field trial residue egg RAC 1 0.07 r ecommended in Memo, S. Levy, 31 - JAN - 08; DP# 340137 1 See DP#285474, G. Kramer, 3/22/04. 2 C attle , goat, horse, and sheep. 3 Apple and pear residues were translated to the remai ning 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 eggplant 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 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). 12 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).Novaluron Di etary Exposure & Risk Assessment DP#: 364235

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### Attachment 2: DEEM - FCID  Chronic Residue Input File Filename: C: \ Documents and Settings \ jlangsda \ My Documents \ Chemicals \ Novaluron \ Pepper, Strawberry, Snap Bean, Cucumber, etc \ DEEM \ 124002 - ch ronic - 2009 - JLV__10 - NOV - 09.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 modified: 09 - 15 - 2009/11:04:41/8 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 0.02 5000 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 0.025000 1.000 1.000 01032960 1C Potato, chips 0.025000 1.000 1.000 01032970 1C Potato, dry (granules/ flakes) 0.025000 6.500 1.000 01032971 1C Potato, dry (granules/ flakes) - b 0.025000 6.500 1.000 01032980 1C Potato, flour 0.025000 6.500 1.00 0 01032981 1C Potato, flour - babyfood 0.025000 6.500 1.000 01032990 1C Potato, tuber, w/peel 0.025000 1.000 1.000 01032991 1C Potato, tuber, w/peel - babyfood 0.025000 1.000 1.000 01033000 1C Potato, tuber , w/o peel 0.025000 1.000 1.000 01033001 1C Potato, tuber, w/o peel - babyfood 0.025000 1.000 1.000 01033660 1CD Sweet potato 0.025000 1.000 1.000 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 1.000 0 5010710 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 1.0 00 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 Turni p, 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 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 060303 80 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 06030980 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 08001480 8 Eggplant 0.140000 1.000 1.000 08002340 8 Okra 0.160000 1.000 1.000 08002700 8 Pepper, be ll 0.140000 1.000 1.000 08002701 8 Pepper, bell - babyfood 0.140000 1.000 1.000 08002710 8 Pepper, bell, dried 0.140000 1.000 1.000 08002711 8 Pepper, bell, dried - babyfood 0.1400 00 1.000 1.000 08002720 8 Pepper, nonbell 0.160000 1.000 1.000Novaluron Di etary Exposure & Risk Assessment DP#: 364235

PC Code: 124002

Page 12 of 15 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 Chayote, fruit 0.044000 1.000 1.000 09021020 9B Ch inese 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 09023570 9B Squash, winter 0.044000 1.000 1.000 090 23571 9B Squash, winter - babyfood 0.044000 1.000 1.000 11000070 11 Apple, fruit with peel 0.578000 1.000 1.000 11000080 11 Apple, peeled fruit 0.578000 1.000 1.000 11000081 11 Apple, peeled fruit - babyfood 0.578000 1.000 1.000 11000090 11 Apple, dried 0.578000 8.000 1.000 11000091 11 Apple, dried - babyfood 0.578000 8.000 1.000 11000100 11 Apple, juice 0.578000 0.100 1.000 11000101 11 Apple, juice - babyfood 0.578000 0.100 1.000 11000110 11 Apple, sauce 0.578000 1.000 1.000 11000111 11 Apple, sauce - babyfood 0.578000 1.000 1.000 11001290 11 Crabapp le 0.578000 1.000 1.000 11002100 11 Loquat 0.833000 1.000 1.000 11002660 11 Pear 0.833000 1.000 1.000 11002661 11 Pear - babyfood 0.8 33000 1.000 1.000 11002670 11 Pear, dried 0.833000 6.250 1.000 11002680 11 Pear, juice 0.833000 0.100 1.000 11002681 11 Pear, juice - babyfood 0.833000 0.100 1.000 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 1.0 00 12000901 12 Cherry - babyfood 2.170000 1.000 1.000 12000910 12 Cherry, juice 2.170000 0.100 1.000 12000911 12 Cherry, juice - 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 0.610000 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 1.000 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 - babyfood 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 1.000Novaluron Di etary Exposure & Risk Assessment DP#: 364235

PC Code: 124002

Page 13 of 15 13021910 13B Huckleberry 1.970000 1.000 1.000 21000440 M Beef, meat 0.112000 1.000 1.000 21000441 M Beef, meat - babyfood 0.112000 1.000 1.000 21000450 M Beef , meat, dried 0.112000 1.920 1.000 21000460 M Beef, meat byproducts 0.190000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 0.190000 1.000 1.000 21000470 M Beef, fat 2.430000 1.000 1.000 21000471 M Beef,fat - babyfood 2.430000 1.000 1.000 21000480 M Beef, kidney 0.183000 1.000 1.000 21000490 M Beef, liver 0.190000 1.000 1.000 21000 491 M Beef, liver - babyfood 0.190000 1.000 1.000 23001690 M Goat, meat 0.112000 1.000 1.000 23001700 M Goat, meat byproducts 0.190000 1.000 1.000 23001710 M Goat, fat 2.430000 1.000 1.000 23001720 M Goat, kidney 0.183000 1.000 1.000 23001730 M Goat, liver 0.190000 1.000 1.000 24001890 M Horse, meat 0.112000 1.000 1.000 25002900 M Pork, meat 0.002400 1.000 1.000 25002901 M Pork, meat - babyfood 0.002400 1.000 1.000 25002910 M Pork, skin 0.053000 1.000 1.000 25002920 M Pork, mea t byproducts 0.004100 1.000 1.000 25002921 M Pork, meat byproducts - babyfood 0.004100 1.000 1.000 25002930 M Pork, fat 0.053000 1.000 1.000 25002931 M Pork, fat - babyfood 0.053 000 1.000 1.000 25002940 M Pork, kidney 0.004100 1.000 1.000 25002950 M Pork, liver 0.004000 1.000 1.000 26003390 M Sheep, meat 0.112000 1.000 1.000 26003391 M Sheep, meat - babyfood 0.112000 1.000 1.000 26003400 M Sheep, meat byproducts 0.190000 1.000 1.000 26003410 M Sheep, fat 2.430000 1.000 1.000 26003411 M Sheep, fat - babyfood 2.430000 1.000 1.000 26003420 M Sheep, kidney 0.183000 1.000 1.000 26003430 M Sheep, liver 0.190000 1.000 1.000 27002220 D Milk, fat 2.820000 1.000 1.000 27002221 D Milk, fat - baby food/infant for 2.820000 1.000 1.000 27012230 D Milk, nonfat solids 0.113000 1.000 1.000 27012231 D Milk, nonfat solids - baby food/in 0.113000 1.000 1.000 40000930 P Chicken, meat 0.030000 1.000 1.000 40000931 P Chicken, meat - babyfood 0.030000 1.000 1.000 40000940 P Chicken, liver 0.040000 1.000 1.000 40000950 P Chicken, meat byproducts 0.040000 1.000 1.000 40000951 P Chicken, meat byproducts - babyfoo 0.040000 1.000 1.000 40000960 P Chicken, fat 0.400000 1.000 1.000 40000961 P Chicken, fat - babyfood 0.400000 1.000 1.000 40000970 P C hicken, skin 0.400000 1.000 1.000 40000971 P Chicken, skin - babyfood 0.400000 1.000 1.000 50003820 P Turkey, meat 0.030000 1.000 1.000 50003821 P Turkey, meat - babyfood 0.030000 1.000 1.000 50003830 P Turkey, liver 0.040000 1.000 1.000 50003831 P Turkey, liver - babyfood 0.040000 1.000 1.000 50003840 P Turkey, meat byproducts 0.040000 1.000 1.000 50 003841 P Turkey, meat byproducts - babyfood 0.040000 1.000 1.000 50003850 P Turkey, fat 0.400000 1.000 1.000 50003851 P Turkey, fat - babyfood 0.400000 1.000 1.000 50003860 P Turkey, skin 0.400000 1.000 1.000 50003861 P Turkey, skin - babyfood 0.400000 1.000 1.000 60003010 P Poultry, other, meat 0.030000 1.000 1.000 60003020 P Poultry, other, liver 0.040000 1.00 0 1.000 60003030 P Poultry, other, meat byproducts 0.040000 1.000 1.000 60003040 P Poultry, other, fat 0.400000 1.000 1.000 60003050 P Poultry, other, skin 0.400000 1.000 1.000 70001450 P Egg, w hole 0.070000 1.000 1.000 70001451 P Egg, whole - babyfood 0.070000 1.000 1.000 70001460 P Egg, white 0.070000 1.000 1.000 70001461 P Egg, white (solids) - babyfood 0. 070000 1.000 1.000 70001470 P Egg, yolk 0.070000 1.000 1.000 70001471 P Egg, yolk - babyfood 0.070000 1.000 1.000 86010000 O Water, direct, all sources 0.002600 1.000 1.000 8602000 0 O Water, indirect, all sources 0.002600 1.000 1.000 95001280 O Cottonseed, oil 0.600000 1.000 1.000 95001281 O Cottonseed, oil - babyfood 0.600000 1.000 1.000 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 1.000Novaluron Di etary Exposure & Risk Assessment DP#: 364235

PC Code: 124002

Page 14 of 15 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 0.140000 1.000 1.000 95003620 O Sugarcane, sugar 0.125000 1.000 1.000 95003621 O Sugarcane, sugar - babyfood 0.12500 0 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 Di etary Exposure & Risk Assessment DP#: 364235

PC Code: 124002

Page 15 of 15



### Atta chment 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 \ jlangsd a \ My Documents \ Chemicals \ Novaluron \ Pepper, Strawberry, Snap Bean, Cucumber, etc \ DEEM \ 124002 - chronic - 2009 - JLV__10 - NOV - 09.R98 Adjustment factor #2 used. Analysis Date 11 - 10 - 2009/16:30:36 Residue file d ated: 11 - 10 - 2009/16:29:35/8 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) 0.002749 25.0% U.S. Population (spri ng season) 0.002724 24.8% U.S. Population (summer season) 0.002798 25.4% U.S. Population (autumn season) 0.002823 25.7% U.S. Population (winter season) 0.002639 24.0% Northeast region 0.002840 25.8% Midwest region 0.002775 25.2% Southern region 0.002616 23.8% Western region 0.002850 25.9% Hispanics 0.002945 26.8% Non - hispanic whites 0.002580 23.5% Non - hispanic blacks 0.0 03328 30.3% Non - hisp/non - white/non - black 0.003396 30.9% All infants (< 1 year) 0.004732 43.0% Nursing infants 0.002662 24.2% Non - nu rsing infants 0.005518 50.2% Children 1 - 6 yrs 0.007618 69.3% Children 7 - 12 yrs 0.004024 36.6% Females 13 - 19 (not preg or nursing) 0.002056 18.7% Females 20+ (not preg or nursing) 0.001843 16.8% Females 13 - 50 yrs 0.002043 18.6% Females 13+ (preg/not nursing) 0.002370 21.5% Females 13+ (nursing) 0.002357 21.4% Males 13 - 19 yrs 0.002654 24.1% Males 20+ yrs 0.002054 18.7% Seniors 55+ 0.001996 18.1% Children 1 - 2 yrs 0.009204 83.7% Children 3 - 5 yrs 0.007142 64.9% Children 6 - 12 yrs 0.004307 39.2% Youth 13 - 19 yrs 0.002365 21.5% Adults 20 - 49 yrs 0.001944 17.7% Adults 50+ yrs 0.001965 17.9% Females 13 - 49 yrs 0.001856 16.9%

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