Risk Assessment for Safety of Orange Juice Containing Fungicide Carbendazim

Transcription

1 Risk Assessment for Safety of Orange Juice Containing Fungicide Carbendazim 1. Memorandum: Acute, Chronic and Cancer s for the Presence of Carbendazim in Orange Juice January 18, Memorandum: s for the Fungicide Carbendazim (MBC), Including Potential Residues in Orange Juice January 17, 2012 U.S. Environmental Protection Agency January 19, 2012

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19 risk assessment that includes potential residues in orange juice as well as exposure to MBC from the registered uses of TM. Acute, chronic, and cancer dietary exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model (DEEM-FCID ) and food consumption data from the U.S. Department of Agriculture s (USDA s) Continuing Surveys of Food Intakes by Individuals (CSFII). The analyses were conducted using available residue data for existing uses of TM and orange juice containing residues at levels of 10 ppb, 50 ppb, and 80 ppb. These values were chosen by EPA to represent a range in residues based on preliminary discussions with FDA; however, no residues above 35 ppb have been reported in orange juice. In addition to food and orange juice, estimated drinking water concentrations (EDWC s) were included in the assessments. A refined probabilistic acute dietary exposure assessment was conducted for thiophanate-methyl in food and drinking water (A. Parmar, 06/24/09, D360625). This previous assessment served as the basis for the current risk assessment for MBC, and included use of food residue monitoring data (from USDA s Pesticide Data Program (PDP)) as well as percent crop treated (PCT) information. For orange juice, HED assumed that 100% of orange juice in the US food supply contains carbendazim residues at levels indicated above. The estimated drinking water concentrations for MBC, resulting from use of thiophanate-methyl, were provided by the Environmental Fate and Effects Division (EFED) and incorporated directly into the dietary assessments. The drinking water estimates provided by EFED were based on the use pattern for thiophanate-methyl, and included 2 major turf scenarios and numerous crop scenarios. The highest modeled drinking water values were derived from use on turf; these values were used in the corresponding acute, chronic and cancer dietary assessments; the next highest set of values, also based on application to turf, were approximately 50% lower, and all crop estimates were even lower. Use of the high-end estimates provides an upper-bound estimate of potential exposure to MBC from drinking water. In addition, for the purpose of characterizing exposure and risk estimates, HED conducted assessments using drinking water monitoring data. There are no acute, chronic or cancer risk estimates of concern associated with MBC residues in food, including residues in orange juice, even though conservative assumptions were used in the assessments. When drinking water exposures were added to the food residues for acute, chronic and cancer dietary assessments, the most significant exposure was from modeled residues in drinking water. While there appear to be risk estimates of concern from drinking water alone, there are several reasons drinking water residue estimates are considered to result in high-end, conservative exposures, which are likely to overestimate actual risk from residues in drinking water: 1) The high end turf scenario was one of 2 turf scenarios designed to be representative of the highest exposure possible from all turf in the US; it provided the highest estimated drinking water values, while residues from the second turf scenario and all other crop scenarios were at least 50% lower; Page 2 of 57

20 2) The MBC turf residue estimates were generated by assuming the maximum application rate of TM and 100% instantaneous conversion to MBC. It would be unlikely that all of the TM applied would be immediately converted to MBC; this is especially conservative for the peak (acute) values; 3) For turf uses, the Agency s drinking water models assume the entire watershed is treated, and at the maximum application rate which while legally allowed, would rarely if ever actually occur; 4) The dietary model assumes that all drinking water exposure comes from the high end turf scenario (i.e., nationally, all exposure from drinking water is based on these high end turf residues); 5) For characterization purposes, HED also assessed exposure and risk estimates using PDP drinking water monitoring data, and risk estimates were below HED s level of concern. HED does not typically use drinking water monitoring data quantitatively in acute or chronic risk assessments, since such residues cannot be linked to specific use patterns, samples are not collected with sufficient frequency to detect potential peak residues, and since the monitored data are likely to reflect typical rather than maximum label rates. However, for the purpose of this assessment, risks were assessed quantitatively using monitoring data to provide additional exposure and risk estimate characterization. While the monitored residues may not reflect peak values, the fact that there are a number of detections over the course of several years indicates that monitoring was conducted in areas where use of TM (resulting in residues of MBC) is likely to have occurred. Detailed results of the dietary exposure and risk assessments are provided below. Acute Dietary Exposure Food Uses and Orange Juice The acute dietary exposure and risk estimates from food alone, including orange juice at all three residue levels, are below HED s level of concern (<100 % of the acute population adjusted dose (apad)) at the 99.9 th percentile of exposure. Carbendazim dietary exposure from food is 25% of the apad for the general US population and 58% of the apad for children 1-2 years old, the most highly exposed population subgroup. Food Uses, Orange Juice and Drinking Water Acute dietary exposure and risk estimates from food, orange juice and drinking water based on inclusion of high end drinking water modeling residues are above HED s level of concern (>100% apad) for infants (<1 year old), at 140% of the apad. Risk estimates for all other subpopulations are below the level of concern, including the general US population, at 52% apad. When the highest monitored drinking water value from PDP was used in the assessment (along with food and orange juice), risk estimates were below HED s level of concern for all population subgroups; the highest exposed population subgroup was children 1-2 years old, at 58% apad, with the general US population at 25% apad. Page 3 of 57

21 Chronic Dietary Exposure Food Uses and Orange Juice Chronic dietary exposure and risk estimates are below HED s level of concern for all population subgroups for all scenarios based on food uses of TM and potential MBC residues in orange juice; the most highly exposed population subgroup is children 1-2 years old, at 19% cpad, with the general US population at 5% cpad. Food Uses, Orange Juice and Drinking Water When high end modeled drinking water residues were included, the most highly exposed population subgroup was all infants (<1 year old) at 130% cpad, while all other population subgroups had risk estimates below the level of concern, including the general US population at 44% cpad. When the average monitored drinking water value from PDP was used, there were no risk estimates of concern for any population subgroup, including the most highly exposed children 1-2 years old at 20% cpad. The chronic dietary risk estimate for the general US population was 5% cpad. Cancer Dietary Exposure Food Uses and Orange Juice The lifetime cancer risk estimate for the general US population is below HED s level of concern when food residues and orange juice are included in the assessment, with risk estimates less than 1 in a million (3.2 x 10-7 ). While not of concern, this risk estimate is still conservative because exposure to MBC residues in orange juice is not expected to occur over a lifetime. Food Uses, Orange Juice and Drinking Water When modeled drinking water residues were included, the cancer risk estimate was approximately 2 in a million (1.9 x 10-6 ), which is still not of concern when the conservative nature of the exposure estimates is considered. Further, use of PDP drinking water residues results in risk estimates comparable to those from food alone, including orange juice. I. Introduction Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no adverse health effects). This is referred to as the population-adjusted dose (PAD). The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors. For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. For cancer assessments, in general, HED is concerned when the lifetime cancer risk estimates exceed the range of one in one million (expressed as 1 x 10-6 ). Page 4 of 57

22 References which discuss the dietary 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: 12/6061.pdf; or see SOP 99.6 (20 Aug 1999). The most recent dietary assessment for thiophanate-methyl was conducted in support of new uses on various crops (A. Parmar, 06/24/09, Barcode ). II. Residue Information Carbendazim (MBC) is a systemic fungicide of the benzimidazole chemical class. Its pesticidal action derives from inhibition of fungal β-tubulin polymerization. MBC represents the pesticidally active moiety for the fungicide thiophanate-methyl, which is degraded to MBC in the environment. Tolerances listed in 40 CFR are expressed in terms of thiophanatemethyl, and its metabolite, methyl 2-benzimidazoyl carbamate (MBC or carbendazim). HED determined that, in plants, the residues of concern for risk assessment include parent thiophanatemethyl and its metabolites carbendazim and 2-AB (Memo, S. Funk, 3/6/97). Separate dietary exposure and risk assessments were performed for thiophanate-methyl and MBC (including 2AB) because they have different toxicological endpoints (effects) and doses for risk assessment. This dietary exposure assessment addresses only residues of MBC, and includes potential residues in orange juice combined with residues in other foods as well as drinking water. Existing Uses For the purpose of this assessment of existing uses and orange juice, no new PDP monitoring data were included. The residues used in this assessment were calculated to include the residues of concern, MBC +2-AB, based on residues of TM and MBC residues either measured in field residue trials or calculated using ratios from metabolism studies (D360625, 06/24/09, A.Parmar). In addition, HED incorporated estimates of percent crop treated for certain existing uses; these assumptions are captured in the attachments. Finally, both default and empirical processing factors were used in the dietary assessments for existing uses, also presented in the attachments. Orange Juice (OJ) Based on preliminary information received from FDA, HED assessed exposure to potential residue levels of 10, 50, and 80 ppb in orange juice, in order to characterize exposure and risk for a range of residues. However, HED notes that no residues above 35 ppb have been reported in orange juice. A juice processing factor for orange juice was not needed since the residue levels used were assumed concentrations in single strength juice. III. Drinking Water Data References: Drinking Water Assessment: Thiophanate-methyl and degradate methyl 2- benzimidzolylcarbamate or Carbendazim (MBC) for additional food uses and IR- 4 crops; DP Barcode: D335121; M. Barrett. Page 5 of 57

23 The estimated drinking water concentrations (EDWCs) for MBC were calculated using the linked Pesticide Root Zone Model (PRZM) and Exposure Analysis Monitoring System (EXAMS) models, with the Index Reservoir; for certain commodities the Percent Cropped Area (PCA) adjustment was used, but not for turf. Typically EFED provides three drinking water values from each modeled scenario. The model estimates potential drinking water residues using the crop or scenario specific use pattern and 30 years of weather data. The output from the model consists of the 90 th percentile peak and average values for acute and chronic assessments, respectively. The acute value represents the 4 th highest value in 30 years of modeled residues; the chronic value is derived from the average DW estimate from each of the 30 years, and is the 4 th highest average. The modeled DW estimate used in the cancer assessment is the average of the averages. In addition to these values, for acute dietary assessment, a distribution of daily modeled residue values over 30 years was provided (i.e., the daily time series residues) for use in the model. The assessment was based on the application of TM to turf with immediate conversion of TM to MBC; the modeled drinking water estimates were based on the fate parameters for MBC, and a number of standard model input parameters, including climate and soil types, designed to provide drinking water residues representative of the highest potential for exposure to residues from turf throughout the US. In addition to the 2 major turf scenarios assessed, there were numerous crop scenarios modeled as well. Turf residues provided the highest drinking water estimates, and all others were lower. The models and their descriptions are available at the EPA internet site: HED also looked at monitoring data collected by the US Department of Agriculture through its Pesticide Data Program (PDP): m&rightnav1=pesticidedataprogram&topnav=&leftnav=scienceandlaboratories&page=pesticidedataprogram&r esulttype PDP monitored both finished (565 samples) and untreated drinking water (558 samples) from 2006 through In finished drinking water, only 1 sample had a detectable residue for MBC, at parts per billion (ppb). In untreated drinking water, there were a total of 55 detected residues, ranging from to ppb. For the current dietary assessment, HED used the highest monitored value of ppb, and the highest average from any year (2008), at ppb, as potential drinking water estimates for carbendazim; these were included in the dietary assessment, either the highest monitored value for acute, or the average value for chronic and cancer (see Table 1 below) for the purpose of risk characterization. Regardless of the source of estimated drinking water concentrations, water residues were directly incorporated in the DEEM- FCID analyses into the food categories water, direct, all sources and water, indirect, all sources. Page 6 of 57

24 Table 1. Summary of Estimated Drinking Water Concentrations for Carbendazim (MBC) Drinking Water Source Crop Acute (ppb) 1 Chronic (ppb) 2 Cancer (ppb) 3 Surface water- Turf Modeling data (use distribution) PDP Untreated NA Water (use point estimate) 1 For modeled residues, the acute value is the 90 th percentile peak value; for monitored values, the highest residue detected by PDP (2008) was used. 2 For modeled residues, the chronic value is the 90 th percentile average value; for monitored DW, the residue used was the average detected residue from For modeled residues, the cancer value is the overall average value; for monitored DW, the residue used was the average detected residue from IV. DEEM-FCID Program and Consumption Information Carbendazim dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, Version 2.03 which incorporates consumption data from USDA s CSFII, and The , 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days. Foods as consumed (e.g., apple pie) are linked to EPAdefined 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 , 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, and females For 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 daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the cpad. This procedure is performed for each population subgroup. For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or matched in multiple random pairings with residue values Page 7 of 57

25 and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the apad on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all analyses. However, for less refined assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment. V. Toxicological Information The carbendazim doses and endpoints for dietary exposure assessment are summarized in Table 2. A more detailed discussion of the toxicological effects and endpoints chosen for risk assessment is included in the attachments. Table 2. Doses and Endpoints for Carbendazim for Use in Dietary Human Health Risk Assessment Uncertainty/ RfD, PAD, Level Study and Toxicological Effects Exposure/ Point of FQPA Safety of Concern for Scenario Departure Factors Risk Assessment Acute Dietary (Females years of age) NOAEL = 10 mg/kg/day UF A = 10x UF H = 10x FQPA SF= 10x Acute RfD = 0.10 mg/kg/day apad =0.01 mg/kg/day Developmental toxicity oral (gavage) study in the rat with MBC Developmental LOAEL = 20 mg/kg/day based on increases in skeletal variations and malformations in fetuses. Single dose rat study with MBC (Nakai et al., 1992) Acute Dietary, General Population (including infants and children) LOAEL = 50 mg/kg/day (NOAEL not established) UF A = 10x UF H = 10x UF L = 3x FQPA SF= 10x Acute RfD = 0.17 mg/kg/day apad = mg/kg/day LOAEL = 50 mg/kg based on adverse testicular effects: 2 days after exposure = sloughing (premature release) of immature germ cells; and 70 days after exposure = atrophy of seminiferous tubules in one testicle, significant decrease in seminiferous tubule diameter and slight abnormal growth of the efferent ductules. 2 year chronic oral toxicity study in the dog with MBC Chronic Dietary (All Populations) NOAEL= 2.5 mg/kg/day UF A = 10x UF H = 10x FQPA SF= 10x cpad = mg/kg/day LOAEL = 12.5 mg/kg/day based on liver effects including swollen, vacuolated hepatic cells, hepatic cirrhosis, chronic hepatitis, and biochemical alterations indicative of liver damage. Page 8 of 57

26 Table 2. Doses and Endpoints for Carbendazim for Use in Dietary Human Health Risk Assessment Uncertainty/ RfD, PAD, Level Study and Toxicological Effects Exposure/ Point of FQPA Safety of Concern for Scenario Departure Factors Risk Assessment Cancer Q1* = 2.39 x 10-3 (mg/kg/day) -1 2 year mouse dietary carcinogenicity study Based on an increased incidence of hepatocellular (adenoma/and/or carcinoma) tumors. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF L = use of a LOAEL to extrapolate a NOAEL. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. VI. Results/Discussion As stated above, for acute and chronic assessments, HED is concerned when dietary risk estimates exceed 100% of the PAD. The DEEM-FCID analyses estimate the dietary exposure of the US population and various population subgroups. The results reported in Tables 3 and 4 are for the general US population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, and females The cancer risk estimates reported in Table 5 are for the general US population only. There are no acute, chronic or cancer risk estimates of concern associated with MBC residues in food, including residues in orange juice, even though conservative assumptions were used in the assessments. When drinking water exposures were added to the food residues for acute, chronic and cancer dietary assessments, the most significant exposure was from potential modeled residues in drinking water. Acute Dietary Exposure Because percent crop treated information was included in the acute dietary exposure and risk estimates, HED reported exposure and risk at the 99.9 th percentile of exposure. Acute dietary exposure and risk estimates from food alone, including orange juice at all three residue levels, are below HED s level of concern (i.e., <100 % of the acute population adjusted dose (apad)). Carbendazim dietary exposure from food (and orange juice) is 25% of the apad for the general US population and 58% of the apad for children 1-2 years old, the most highly exposed population subgroup. Acute dietary exposure and risk estimates from food, orange juice and drinking water based on inclusion of the highest drinking water modeling residues are above HED s level of concern (>100% apad) for infants (<1 year old), at 140% of the apad. Risk estimates for all other subpopulations are below the level of concern, including the general US population, at 52% apad. Page 9 of 57

27 When the highest monitored drinking water value from PDP was used in the assessment (along with food and orange juice), risk estimates were below HED s level of concern for all population subgroups; the highest exposed population subgroup was children 1-2 years old, at 58% apad, with the general US population at 25% apad. Chronic Dietary Exposure Chronic dietary exposure and risk estimates are below HED s level of concern for all population subgroups for all scenarios based on food uses of TM and potential MBC residues in orange juice; the most highly exposed population subgroup is children 1-2 years old, at 19% cpad, with the general US population at 5% cpad. When modeled drinking water residues were included, the most highly exposed population subgroup was all infants (<1 year old) at 130% cpad, while all other population subgroups had risks below the level of concern, including the general US population at 44% cpad. When the average monitored drinking water value from PDP was used, there were no risk estimates of concern for any population subgroup, including the most highly exposed children 1-2 years old at 20% cpad. The chronic dietary risk estimate for the general US population was 5% cpad. Cancer Risk Estimates for Dietary Exposure The lifetime cancer risk estimate for the general US population is below HED s level of concern when food residues and orange juice are included in the assessment, with risk estimates less than 1 in a million (3.2 x 10-7 ). While not of concern, this risk estimate is still conservative because exposure to MBC residues in orange juice is not expected to occur over a lifetime. When modeled drinking water residues were included, the cancer risk estimate was approximately 2 in a million (1.9 x 10-6 ), which is still not of concern when the conservative nature of the exposure estimates is considered. Further, use of PDP drinking water residues results in risk estimates comparable to those from food alone, including orange juice. Table 3. MBC Acute Dietary Risk Estimates (99.9 th percentile of exposure). Existing Uses Existing Uses & OJ 10ppb Existing Uses & OJ 50 ppb Existing Uses & OJ 80 ppb Existing Uses & OJ 80 ppb & PDP H2O (0.121ppb) Existing Uses & OJ 80 ppb & Modeled Turf H2O Population % apad % apad % apad % apad % apad % apad General U.S. Population All Infants (< 1 year old) Children 1-2 years old Children 3-5 years old Children 6-12 years old Page 10 of 57

28 Table 3. MBC Acute Dietary Risk Estimates (99.9 th percentile of exposure). Existing Uses Existing Uses & OJ 10ppb Existing Uses & OJ 50 ppb Existing Uses & OJ 80 ppb Existing Uses & OJ 80 ppb & PDP H2O (0.121ppb) Existing Uses & OJ 80 ppb & Modeled Turf H2O Population % apad % apad % apad % apad % apad % apad Youth years old Females years old Existing Uses = Based on Registered uses of Thiophanate-methyl. Table 4. MBC Chronic Dietary Risk Estimates Population Subgroup Existing Uses & OJ 80 ppb & PDP H2O Existing Uses & OJ 80 ppb & Modeled Turf H2O (46.18ppb) Existing Existing Uses Uses & OJ 80 ppb (0.019ppb) % cpad % cpad % cpad % cpad General U.S. Population All Infants (< 1 year old) Children 1-2 years old Children 3-5 years old Children 6-12 years old Youth years old Females years old Existing Uses = Based on Registered uses of Thiophanate-methyl. Table 5. MBC Cancer Dietary Risk Estimates Existing Uses & OJ 80 ppb Existing Uses & OJ 80 ppb & PDP H2O (0.019ppb) Existing Uses & OJ 80 ppb & Modeled Turf H2O (31.09ppb) Population Existing Uses General U.S. Population 9.7 x x x x 10-6 Existing Uses = Based on Registered uses of Thiophanate-methyl. VII. Characterization of Inputs/Outputs All of these dietary exposure analyses relied primarily on field trial data for MBC residues in/on food and limited PDP monitoring data for MBC where available. While percent crop treated estimates for TM were available for some crops, 100 % crop treated was assumed for orange juice and for all other crops for which no information was available. Therefore, even though some refinements have been used, many of the assumptions tend to overestimate potential Page 11 of 57

29 exposure through food, including orange juice. HED emphasizes that the orange juice residues assessed were intended to provide a range of exposure and risk estimates, and that no MBC residues above 35 ppb have been detected in any juice samples. While there appear to be risk estimates of concern from drinking water alone, there are several reasons drinking water residue estimates are considered to result in high-end, conservative exposures, which are likely to overestimate actual risk from residues in drinking water: 1) The high end turf scenario was one of 2 turf scenarios designed to be representative of the highest exposure possible from all turf in the US; it provided the highest estimated drinking water values, while residues from the second turf scenario and all other crop scenarios were at least 50% lower; 2) The MBC turf residue estimates were generated by assuming the maximum application rate of TM and 100% instantaneous conversion to MBC. It would be unlikely that all of the TM applied would be immediately converted to MBC; this is especially conservative for the peak (acute) values; 3) For turf uses, the Agency s drinking water models assume the entire watershed is treated, and at the maximum application rate which while legally allowed, would rarely if ever actually occur; 4) The dietary model assumes that all drinking water exposure comes from the high end turf scenario (i.e., nationally, all exposure from drinking water is based on these high end turf residues); 5) For characterization purposes, HED also assessed exposure and risk estimates using PDP drinking water monitoring data, and risk estimates were below HED s level of concern. HED does not typically include PDP monitoring data quantitatively in acute or chronic risk assessments, since monitored residues cannot be linked to specific use patterns, samples are not collected with sufficient frequency to detect potential peak residues, and since the monitored data are likely to reflect typical rather than maximum label rates. However, for the purpose of this assessment, risks were assessed quantitatively using monitoring data to provide additional exposure and risk characterization. While the monitored residues may not reflect peak values, the fact that there are a number of detections over the course of several years indicates that PDP monitoring was conducted in areas where use of TM (resulting in residues of MBC) is likely to have occurred. VIII. Conclusions The exposure estimates that were generated are conservative estimates of the actual dietary exposures that might occur. Even though such conservative assumptions were used, the dietary risk estimates are below HED s level of concern for all population subgroups for the acute, chronic, and cancer scenarios except when high-end modeled drinking water residues were included. Risk estimates from food alone, including a range of potential residues in orange juice, were not of concern. Page 12 of 57

30 IX. List of Attachments Attachment 1: Acute Residue Input File-Existing Uses Attachment 2: Acute Result File-Existing Uses Attachment 3: Acute Residue Input File-Existing Uses + 10 ppb OJ Attachment 4: Acute Result File-Existing Uses + 10 ppb OJ Attachment 5: Acute Result File-Existing Uses + 50 ppb OJ Attachment 6: Acute Result File-Existing Uses + 80 ppb OJ Attachment 7: Acute Residue Input File-Existing Uses + 80 ppb OJ + H2O (highest PDP) Attachment 8: Acute Result File-Existing Uses + 80 ppb OJ + H2O (highest PDP) Attachment 9: Acute Residue Input File-Existing Uses + 80 ppb OJ+ H2O (modeled turf distribution) Attachment 10: Acute Result File-Existing Uses + 80 ppb OJ+ H2O (modeled turf distribution) Attachment 11: Chronic Residue Input File-Existing Uses Attachment 12: Chronic Result File-Existing Uses Attachment 13: Chronic Residue Input File-Existing Uses + 80 ppb OJ Attachment 14: Chronic Result File-Existing Uses + 80 ppb OJ Attachment 15: Chronic Residue Input File-Existing Uses + 80 ppb OJ + H2O (average PDP) Attachment 16: Chronic Result File-Existing Uses + 80 ppb OJ + H2O (average PDP) Attachment 17: Chronic Residue Input File-Existing Uses + 80 ppb OJ+ H2O (modeled turf) Attachment 18: Chronic Result File-Existing Uses + 80 ppb OJ+ H2O (modeled turf) Attachment 19: Cancer Result File-Existing Uses Attachment 20: Cancer Result File-Existing Uses + 80 ppb OJ Attachment 21: Cancer Result File-Existing Uses + 80 ppb OJ + H2O (average PDP) Attachment 22: Cancer Residue Input File-Existing Uses + 80 ppb OJ+ H2O (modeled turf) Attachment 23: Cancer Result File-Existing Uses + 80 ppb OJ+ H2O (modeled turf) Attachment 24: BEAD s Percent Crop Treated Estimates (2009) Attachment 25: Residue Distribution Files (RDFs) for MBC Attachment 26: Processing Factors Used in the MBC Assessment Attachment 27: Summary of MBC Toxicological Effects, Endpoints and Doses Page 13 of 57

31 Attachment 1: Acute Residue Input File-Existing Uses U.S. Environmental Protection Agency Ver DEEM-FCID Acute analysis for MBC Residue file name: C:\Deemfcid\MBC\MBC_Acute_existinguse.R98 Analysis Date Residue file dated: /09:10:55/8 Reference dose: arfd = mg/kg bw/day NOEL = 50 mg/kg bw/day Comment: Food alone & Existing uses RDL indices and parameters for Monte Carlo Analysis: Index Dist Parameter #1 Param #2 Param #3 Comment # Code Apple MBC PDP.rdf 09 PDP 3 6 Apricot MBC FT.rdf 4 6 Banana MBC PDP.rdf 09 PDP 6 6 Cantaloupe MBC FT.rdf 8 6 Cucumber MBC FT.rdf 9 6 Onion100 MBC FT.rdf 10 6 Grape MBC FT.rdf 11 6 Greenbean MBC FT.rdf 12 6 Melon MBC FT.rdf 13 6 Nectarine MBC FT.rdf 16 6 Onion MBC FT.rdf 17 6 Pecan MBC FT.rdf 18 6 Peach MBC FT.rdf 19 6 Pear MBC PDP.rdf 09 PDP 21 6 Plum MBC FT.rdf 22 6 Potato MBC FT.rdf 23 6 Pumpkin MBC FT.rdf 24 6 Squash MBC FT.rdf 25 6 Strawberry MBC FT.rdf 27 6 Watermelon MBC PDP.rdf 09 PDP 35 6 Blueberry MBC FT.rdf NU 42 6 MustardGreen MBC FT.rdf NU 44 6 Pistachio MBC FT.rdf NU 45 6 Raspberry100 MBC FT.rdf NU 46 6 Raspberry MBC FT.rdf NU 47 6 Corn Sweet MBC FT.rdf NU 48 6 Tomato MBC FT.rdf NU 51 6 Almond MBC PDP.rdf 09 PDP 52 6 Cherry MBC PDP.rdf 09 PDP 57 6 Water(PAturf) MBC.rdf EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr Almond PDP Almond-babyfood PDP Almond, oil B Almond, oil-babyfood B Apple, fruit with peel PDP Apple, peeled fruit PDP Apple, peeled fruit-babyfood PDP Apple, dried B Apple, dried-babyfood B Apple, juice PDP Apple, juice-babyfood PDP Apple, sauce PDP Apple, sauce-babyfood PDP Apricot Apricot-babyfood Apricot, dried Apricot, juice Apricot, juice-babyfood B Balsam pear Page 14 of 57

32 O Banana PDP O Banana-babyfood PDP O Banana, dried B O Banana, dried-babyfood B C Bean, black, seed C Bean, broad, seed C Bean, cowpea, seed C Bean, great northern, seed C Bean, kidney, seed C Bean, lima, seed C Bean, mung, seed C Bean, navy, seed C Bean, pink, seed C Bean, pinto, seed A Bean, snap, succulent A Bean, snap, succulent-babyfood M Beef, meat M Beef, meat-babyfood M Beef, meat, dried M Beef, meat byproducts M Beef, meat byproducts-babyfood M Beef, fat M Beef,fat-babyfood M Beef, kidney M Beef, liver M Beef, liver-babyfood A Beet, sugar A Beet, sugar-babyfood A Beet, sugar, molasses A Beet, sugar, molasses-babyfood A Cantaloupe A Casaba B Chayote, fruit Cherry PDP Cherry-babyfood PDP Cherry, juice PDP Cherry, juice-babyfood PDP B Chinese waxgourd B Cucumber Garlic Garlic, dried Garlic, dried-babyfood M Goat, meat M Goat, meat byproducts M Goat, fat M Goat, kidney M Goat, liver O Grape O Grape, juice O Grape, juice-babyfood O Grape, leaves O Grape, raisin O Grape, wine and sherry A Honeydew melon M Horse, meat Leek M Meat, game D Milk, fat D Milk, fat - baby food/infant for D Milk, nonfat solids D Milk, nonfat solids-baby food/in D Milk, water D Milk, water-babyfood/infant form D Milk, sugar (lactose)-baby food/ Nectarine Onion, dry bulb Onion, dry bulb-babyfood Page 15 of 57

33 Onion, dry bulb, dried Onion, dry bulb, dried-babyfood Onion, green Peach Peach-babyfood Peach, dried Peach, dried-babyfood Peach, juice Peach, juice-babyfood O Peanut O Peanut, butter O Peanut, oil Pear PDP Pear-babyfood PDP Pear, dried B Pear, juice PDP Pear, juice-babyfood PDP Pecan NU Pistachio NU Plum Plum-babyfood Plum, prune, fresh Plum, prune, fresh-babyfood Plum, prune, dried Plum, prune, dried-babyfood Plum, prune, juice Plum, prune, juice-babyfood C Potato, chips C Potato, dry (granules/ flakes) C Potato, dry (granules/ flakes)-b C Potato, flour C Potato, flour-babyfood C Potato, tuber, w/peel C Potato, tuber, w/peel-babyfood C Potato, tuber, w/o peel C Potato, tuber, w/o peel-babyfood B Pumpkin B Pumpkin, seed M Rabbit, meat Rapeseed, oil NU Rapeseed, oil-babyfood NU M Sheep, meat M Sheep, meat-babyfood M Sheep, meat byproducts M Sheep, fat M Sheep, fat-babyfood M Sheep, kidney M Sheep, liver Soybean, seed Soybean, flour Soybean, flour-babyfood Soybean, soy milk Soybean, soy milk-babyfood or in Soybean, oil Soybean, oil-babyfood B Squash, summer B Squash, summer-babyfood B Squash, winter B Squash, winter-babyfood O Strawberry O Strawberry-babyfood O Strawberry, juice O Strawberry, juice-babyfood Sunflower, seed NU Sunflower, oil NU Sunflower, oil-babyfood NU Triticale, flour Page 16 of 57

34 Triticale, flour-babyfood A Watermelon PDP A Watermelon, juice PDP Wheat, grain Wheat, grain-babyfood Wheat, flour Wheat, flour-babyfood Wheat, germ Wheat, bran Attachment 2: Acute Result File-Existing Uses U.S. Environmental Protection Agency Ver DEEM-FCID ACUTE Analysis for MBC ( data) Residue file: MBC_Acute_existinguse.R98 Adjustment factor #2 used. Analysis Date: /09:16:06 Residue file dated: /09:10:55/8 NOEL (Acute) = mg/kg body-wt/day Acute Pop Adjusted Dose (apad) varies with population; see individual reports Daily totals for food and foodform consumption used. MC iterations = 1000 MC list in residue file MC seed = 10 Run Comment: "Food alone & Existing uses " =============================================================================== Summary calculations (per capita): 95th Percentile 99th Percentile 99.9th Percentile Exposure % apad MOE Exposure % apad MOE Exposure % apad MOE U.S. Population: All infants: Children 1-2 yrs: Children 3-5 yrs: Children 6-12 yrs: Youth yrs: Adults yrs: Adults 50+ yrs: Females yrs: Attachment 3: Acute Residue Input File-Existing Uses + 10 ppb OJ U.S. Environmental Protection Agency Ver DEEM-FCID Acute analysis for MBC Residue file name: C:\Deemfcid\MBC\MBC_Acute_existinguses_10ppbOJ.R98 Analysis Date Residue file dated: /09:18:05/8 Reference dose: arfd = mg/kg bw/day NOEL = 50 mg/kg bw/day Comment: Food alone & Existing uses & 10 ppb OJ RDL indices and parameters for Monte Carlo Analysis: Index Dist Parameter #1 Param #2 Param #3 Comment # Code Apple MBC PDP.rdf 09 PDP 3 6 Apricot MBC FT.rdf 4 6 Banana MBC PDP.rdf 09 PDP 6 6 Cantaloupe MBC FT.rdf 8 6 Cucumber MBC FT.rdf Page 17 of 57

35 9 6 Onion100 MBC FT.rdf 10 6 Grape MBC FT.rdf 11 6 Greenbean MBC FT.rdf 12 6 Melon MBC FT.rdf 13 6 Nectarine MBC FT.rdf 16 6 Onion MBC FT.rdf 17 6 Pecan MBC FT.rdf 18 6 Peach MBC FT.rdf 19 6 Pear MBC PDP.rdf 09 PDP 21 6 Plum MBC FT.rdf 22 6 Potato MBC FT.rdf 23 6 Pumpkin MBC FT.rdf 24 6 Squash MBC FT.rdf 25 6 Strawberry MBC FT.rdf 27 6 Watermelon MBC PDP.rdf 09 PDP 35 6 Blueberry MBC FT.rdf NU 42 6 MustardGreen MBC FT.rdf NU 44 6 Pistachio MBC FT.rdf NU 45 6 Raspberry100 MBC FT.rdf NU 46 6 Raspberry MBC FT.rdf NU 47 6 Corn Sweet MBC FT.rdf NU 48 6 Tomato MBC FT.rdf NU 51 6 Almond MBC PDP.rdf 09 PDP 52 6 Cherry MBC PDP.rdf 09 PDP 57 6 Water(PAturf) MBC.rdf EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr Almond PDP Almond-babyfood PDP Almond, oil B Almond, oil-babyfood B Apple, fruit with peel PDP Apple, peeled fruit PDP Apple, peeled fruit-babyfood PDP Apple, dried B Apple, dried-babyfood B Apple, juice PDP Apple, juice-babyfood PDP Apple, sauce PDP Apple, sauce-babyfood PDP Apricot Apricot-babyfood Apricot, dried Apricot, juice Apricot, juice-babyfood B Balsam pear O Banana PDP O Banana-babyfood PDP O Banana, dried B O Banana, dried-babyfood B C Bean, black, seed C Bean, broad, seed C Bean, cowpea, seed C Bean, great northern, seed C Bean, kidney, seed C Bean, lima, seed C Bean, mung, seed C Bean, navy, seed C Bean, pink, seed C Bean, pinto, seed A Bean, snap, succulent A Bean, snap, succulent-babyfood M Beef, meat M Beef, meat-babyfood M Beef, meat, dried Page 18 of 57

36 M Beef, meat byproducts M Beef, meat byproducts-babyfood M Beef, fat M Beef,fat-babyfood M Beef, kidney M Beef, liver M Beef, liver-babyfood A Beet, sugar A Beet, sugar-babyfood A Beet, sugar, molasses A Beet, sugar, molasses-babyfood A Cantaloupe A Casaba B Chayote, fruit Cherry PDP Cherry-babyfood PDP Cherry, juice PDP Cherry, juice-babyfood PDP B Chinese waxgourd B Cucumber Garlic Garlic, dried Garlic, dried-babyfood M Goat, meat M Goat, meat byproducts M Goat, fat M Goat, kidney M Goat, liver O Grape O Grape, juice O Grape, juice-babyfood O Grape, leaves O Grape, raisin O Grape, wine and sherry A Honeydew melon M Horse, meat Leek M Meat, game D Milk, fat D Milk, fat - baby food/infant for D Milk, nonfat solids D Milk, nonfat solids-baby food/in D Milk, water D Milk, water-babyfood/infant form D Milk, sugar (lactose)-baby food/ Nectarine Onion, dry bulb Onion, dry bulb-babyfood Onion, dry bulb, dried Onion, dry bulb, dried-babyfood Onion, green Orange, juice ppb Full comment: 10 ppb OJ Orange, juice-babyfood ppb Full comment: 10 ppb OJ Peach Peach-babyfood Peach, dried Peach, dried-babyfood Peach, juice Peach, juice-babyfood O Peanut O Peanut, butter O Peanut, oil Pear PDP Pear-babyfood PDP Pear, dried B Page 19 of 57