
                 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 Label to Include Uses on Greenhouse-Grown Cucumber.  

PC Code:  124002
DP Barcode:  D426069
Decision No.:  487502
Registration No.:  53883-GGL
Petition No.:  4E8241
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  Dietary Exposure
Case No.:  7615
TXR 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) 



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 analysis was performed to support a Section 3 request for the proposed use of novaluron on avocado, carrot, and succulent beans, updated crop groupings for fruiting vegetable group 8-10, pome fruit group 11-10, cherry subgroup 12-12A, peach subgroup 12-12B, and plum subgroup 12-12C, and the addition of greenhouse-grown cucumbers to the label.  This memorandum was reviewed by 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 for 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 analysis.  The chronic analysis also incorporated average percent crop treated (PCT) data from the Biological and Economic Analysis Division (BEAD) for apples, blueberries, cabbage, cauliflower, cotton, dry beans, pears, peppers, potatoes, strawberries, and tomatoes, and average percent 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 analysis also incorporated tolerance-level residues for the recently 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 covered by 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 exposure results in a risk estimate that is 28% of the chronic population-adjusted dose (cPAD) for the general U.S. population and 73% 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."

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 that HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population-adjusted dose (PAD).  The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is 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 was conducted by J. Van Alstine (5-FEB-2014; D415835).  

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 chlorophenyl urea degradate (1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea), and the chloroaniline degradate (3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)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 0.01 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 byproducts (except kidney and liver) of cattle, goat, horse, sheep, poultry, and hog.  Additionally, 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 by 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 below (Memo, J. Van Alstine, D418739):  


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
                                     0.70
Harmonize with Codex MRL 
Bean, succulent[1]
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 12-12A[4]
                                      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 will replace the existing tolerances of 1.0 ppm on vegetable, 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 will replace the existing tolerance of 2.0 ppm on fruit, pome, group 11. 
[4] This tolerance will replace the existing tolerance of 8.0 ppm on cherry. 
[5] These tolerances will replace the existing tolerance of 1.9 ppm on fruit, stone, group 12, except cherry.

Residues used in the Chronic Analysis:  The current chronic dietary analysis 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 analysis was refined through the use of average field trial residues for the majority of commodities, average greenhouse trial residues for tomatoes and cucumbers, and calculated ARs for meat, milk, hog, and poultry commodities.  Tolerance-level residues were used for the recently registered peanut and soybean commodities.  Additionally, due to the registered use 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 by 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 analyzed for novaluron.  As a result, residue data from monitoring studies were not used for fish in this assessment.  Based 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 commodities.  

Attachment 1 summarizes the residue, processing factor, and PCT and PCTn data that were incorporated into the current analysis.  

Calculation of ARs in Meat, Milk, Poultry, and Eggs

The potential for secondary transfer of novaluron residues of concern 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 livestock dietary burdens and tolerances were not required for this petition since the incorporation of carrot culls into the dairy cattle livestock diet would not result in higher livestock dietary burdens.  The most recent dietary exposure and risk assessment for 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 Analysis (SLUA) memorandum entitled, "Usage Report Package in Support of Novaluron (124002), BEAN DP# 421177" (C. Doucoure, 30-JUN-2014).  The chronic dietary analysis 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 tomatoes (<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.  Please refer to Attachments 4 and 5 for the PCT and PCTn data provided by BEAD.  

IV.	Drinking Water Data

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 degradate (3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline) (Memo, G. Kramer et al., 03-FEB-04; D297646). The drinking water residues used in the dietary risk assessment were provided 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 food 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).  

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 were evaluated:  1) N+P Regulator, a liquid spray co-formulated with pyriproxyfen; and 2) Novaluron 0.2G, a granular formulation.  The single maximum application rates range from 0.023 to 0.872 lb ai/A and the seasonal maximum application rates 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 application 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 Analysis Modeling System (PRZM/EXAMS), the Screening Concentration in Ground Water (SCI-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 synonym = 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-year 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, respectively.  

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 Type)
                       1-in-10-Year Annual Peak (μg/L)
                       1-in-10-Year Annual Mean (μg/L)
                                30-Year 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 turf 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% molecular 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 unlikely that novaluron would reach potable ground water resources; however, both the chlorophenyl urea and chloroaniline degradates are mobile and persistent in soil, especially under anaerobic conditions.  The estimated concentrations of novaluron, chlorophenyl urea, 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, chlorophenyl urea, and chloroaniline.  The model simulates ground water EDWCs likely to occur when the pesticide is used at the maximum allowable rate in areas where ground water is particularly 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 degradate 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; MWdeg = 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 WI corn scenario provided the highest total EDWC of all of the scenarios and is summarized in Table 4.  Although the novaluron and chlorophenyl urea PRZM-GW EDWCs were considered invalid because of incomplete simulation, the WI scenario still results in the highest combined EDWC.  

Table 4.  Summary of Novaluron EDWCs from Ground Water Using PRZM-GW Modeling for Poultry Operations.[1]
                                 Crop/Scenario
                          Highest Daily Value (ug/L)
                       Post Breakthrough Average (ug/L)
                  Average Simulation Breakthrough Time (Days)
                                   Novaluron
                       Wisconsin Corn - WI Central Sands
                             Met File (14920.dvf)
                                   2.58E-18
                                  Incomplete
                                  Incomplete
                          Chlorophenyl Urea Degradate
                       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 averages are incomplete for these EDWCs.  

EDWCs 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 the residues of concern in drinking water for risk assessment purposes are novaluron, the chlorophenyl urea degradate, and the chloroaniline degradate, these EDWCs were calculated using a molecular weight conversion and then combined for each modeled scenario.  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 ug/L (0.0778 ppm) that was simulated using the PRZM-GW model with the proposed poultry operation use and WI corn 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 2008.  The data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - 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 analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups:  the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years old.

For a 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 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.

VI.	Toxicological Information

The RAB1 toxicologists have reevaluated the novaluron database and reaffirmed the previous conclusion of the Hazard Identification 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 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 5.  Summary of Toxicological Doses and Endpoints for Novaluron for Use in Dietary Exposure Risk Assessments.
                              Exposure/ Scenario
                                      POD
                              Uncertainty/FQPA SF
                       RfD, PAD, LOC for Risk Assessment
                        Study and Toxicological Effects
Acute 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
UFA = 10X
UFH = 10X
FQPA SF = 1X
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 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 adverse-effect level.  LOAEL = lowest-observed adverse-effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = 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 previously, for a chronic assessment, HED is concerned when dietary risk exceeds 100% of the cPAD.  The chronic analysis was performed using DEEM-FCID (ver. 3.16).  The DEEM-FCID analysis 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 year 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 exposure estimates were not of concern to HED (100% cPAD).  The chronic dietary exposure estimates are 28% of the cPAD for the general U.S. population and 73% of the cPAD for children 1-2 years 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
                                 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
                                   0.003071
                                      28
                                      N/A
                                      N/A
 All Infants (<1 year old)
                                        
                                        
                                   0.006289
                                      57
                                        
                                        
 Children 1-2 years old
                                        
                                        
                                   0.008014
                                      73
                                        
                                        
 Children 3-5 years old
                                        
                                        
                                   0.005711
                                      52
                                        
                                        
 Children 6-12 years old
                                        
                                        
                                   0.003746
                                      34
                                        
                                        
 Youth 13-19 years old
                                        
                                        
                                   0.002424
                                      22
                                        
                                        
 Adults 20-49 years old
                                        
                                        
                                   0.002659
                                      24
                                        
                                        
 Adults 50-99 years old
                                        
                                        
                                   0.002671
                                      24
                                        
                                        
 Females 13-49 years old
                                        
                                        
                                   0.002640
                                      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 field 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 highly conservative since they assumed average residues based on field trial data [maximum application rate; minimum pre-harvest interval (PHI); and frozen immediately after harvest].  The current chronic dietary analysis 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 analysis could be further refined 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 28% of the cPAD for the general U.S. population and 73% of the cPAD for children 1-2 years old, 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

Attachment 1:  Processing Factors, ARs, and Average Field 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-2014)
Attachment 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:RAB1

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 establishment (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 2000.1
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 beans
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 2000.1

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
                                    0.0542
                                     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); empirical proc. fact.; average PCT assumed for apple only; other commodities use 100% CT (SLUA; C. Doucoure, 05-DEC-2012; D407102)
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 US 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 1.1 used for cranberry juice; average PCT use for strawberry only; other commodities use 100% CT (SLUA; C. Doucoure, 05-DEC-2012; D407102)

juice (cranberry)
                                      1.1
                                       
                                       

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%
AR
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.
  
  
                                       
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   1.000  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
0101053001 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  Carrot-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, Jerusalem               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                      0.025000   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  
0103296000 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     0.025000   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  
0103366001 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    Chicory, 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              0.005000   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  FHE
0301338000 3A   Shallot, bulb                      0.005000   1.000  1.000  FHE
0302103000 3B   Chive, fresh leaves                0.005000   1.000  1.000  FHE
0302198000 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   Amaranth, 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                             0.005000   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                  0.106000   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  
0501071000 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, snap, 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  1.000  
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 northern, 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  
0603098000 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  0.010  
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  14.300  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 8BC  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, dried                       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  0.100  
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-babyfood                      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  1.000  
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  Apricot-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, juice                       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  Blackberry                         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                 0.005000   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  Elderberry                         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  Cranberry, 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  FHE
1400068000 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   Hazelnut                           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
1500065000 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   Corn, 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  
1500226000 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, flour-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               0.005000   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  1.000  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
1500344000 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, flour-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 19A  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  FHE
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 19B  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, other                      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, oil-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, liver                        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, skin                         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, meat 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; a
            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                       0.047000   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  
4000095000 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, liver-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  1.000  
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  
9500022000 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                              0.005000   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
9500113000 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  FHE
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                      0.005000   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
9500209000 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                       0.005000   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
9500245000 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, juice                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  1.000  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
9500279001 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                      0.005000   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  1.000  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    Sugarcane, 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  FHE
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  FHE








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+                                 0.002635                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%

-------------------------------------------------------------------------------













Attachment 4:  Novaluron (124002) SLUA, Date:  18 June 2014 








Attachment 5:  Update of PCTn:  Novaluron (124002) Use on Sorghum and Sweet Corn (C. Doucoure, et al., 01-FEB-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


