Document ID: EPA-HQ-OPP-2011-0641-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-01-27T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                                                               
                                        OFFICE OF CHEMICAL SAFETY              
                                                       AND POLLUTION PREVENTION

MEMORANDUM

Date:  		10/5/2011

SUBJECT:	Amicarbazone  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Turfgrass

PC Code:  114004
DP Barcode:  D394925
Decision No.:  441345
Registration No.: 66330-46
Petitions:  NA
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  Dietary
Case No.:  NA
TXR No.:  NA
CAS No.:  129909-90-6
MRID No.:  NA
40 CFR:  180.615

		              									
FROM:  	Douglas Dotson, Ph.D., Chemist
		Risk Assessment Branch II
		Health Effects Division (7509P)	
		
THROUGH:	William Cutchin, Chemist
		Thurston Morton, Chemist
		Dietary Exposure Science Advisory Council (DESAC)
		
TO:		Michael Walsh/Kathryn Montague, RM Team 23
		Herbicide Branch
		Registration Division (7505P)		
		

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model DEEM-FCID(TM), Version 2.03 which uses food consumption data from the U.S. Department of Agriculture's (USDA's) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were conducted as part of a human health risk assessment for the requested use of the herbicide amicarbazone on turfgrass and conifers. 

The acute and chronic analyses are both based on conservative estimates of residues in food and drinking water.  For amicarbazone, drinking water is the greatest contributor to dietary exposure and risk.  The estimated drinking water concentrations (EDWCs) represent upper-bound estimates that might be found in surface water and groundwater as a result of the application of amicarbazone on turf and conifers one time at the maximum yearly rate (worst case scenario).  In addition, tolerance-level residues and 100% crop treated assumptions were made for all food commodities.  DEEM default processing factors were used for processed commodities for which they were available.  Because such conservative assumptions were made in the assessments, the resulting exposure and risk estimates are considered to be conservative as well.  HED is confident that the acute and chronic dietary exposure assessments do not underestimate risk to the general U.S. population or any population subgroup.

The acute risk estimates are below HED's level of concern for all population subgroups, including those comprised of infants and children.  Generally, HED is concerned when risk estimates exceed 100% of the population-adjusted dose (PAD).  The acute risk estimate for the general U.S. population is 8.8% of the acute PAD (aPAD).  The population subgroup with the highest acute dietary risk estimate is All Infants, which uses 29% of the aPAD.  As percent crop treated estimates and monitoring data were not incorporated into the acute assessment, the risk estimates are being reported at the 95[th] percentile of exposure.

Chronic risk estimates are below HED's level of concern for all population subgroups.  The risk estimate for the general U.S. population is 17% of the chronic PAD (cPAD).  The most highly exposed population subgroup is All Infants (<1 year old), which uses 48% of the cPAD.

 Amicarbazone has been classified as "not likely to be a human carcinogen."  As a result, a dietary exposure assessment for cancer risk is not necessary.

I.   Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no 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 which 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.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20 Aug 1999).

The last dietary exposure assessment performed for amicarbazone was done in 2005, when tolerances were first established for the chemical (D313754, D. Dotson, 4/19/2005).

II.   Residue Information

This registration action is being performed for the proposed use on turfgrass.  No tolerances are being proposed at the present time.  Established tolerances are for the combined residues of amicarbazone and its metabolites DA amicarbazone and isopropyl-2-OH-DA amicarbazone.  For risk assessment purposes, additional metabolites are included with the three residues to be used for tolerance enforcement.  For assessing human dietary exposure to residues in wheat grain (or any other rotated cereal grains), the two glucose conjugates of DA OH MKH 3586 are included.  These conjugates constituted about 30% of the grain TRR at the 138- and 364-day plant back intervals.  In ruminants, the metabolite tBuOH MKH 3586 is included because of the fact that it was the highest level residue in milk (28% TRR) as well as a major metabolite (> 10% TRR) in muscle and kidney.  For poultry commodities, the metabolites iPr-Acid DA MKH 3586, iPr-1-OH DA MKH 3586, and iPr-Ene DA MKH 3586 are included in the risk assessment because of their presence as major residues in liver, fat, or eggs.  These additional metabolites all contain the triazolinone ring and, therefore, are considered toxicologically equivalent to the parent.  In order to account for these metabolites in the dietary exposure analyses, the tolerances were multiplied by factors that account for their contribution to the exposure.  These factors are given in Table 1 along with the recommended tolerances.

Table 1.  Residue Values for Use in Dietary Exposure Assessment

                                   Commodity

                                Tolerance (ppm)

                               Metabolite Factor

              Residue Value Used in Dietary Exposure Assessments

Field Corn Grain

                                     0.05

                                       -

                                     0.05

Undelinted Cotton Seed

                                     0.07

                                       -

                                     0.07

Soybean Seed

                                      0.8

                                       -

                                      0.8

Wheat Grain

                                      0.1

                                      1.7

                                     0.17

Wheat Milled Byproducts

                                     0.15

                                      1.7

                                     0.255

Milk

                                     0.01

                                      1.6

                                     0.016

Meat of cattle, goats, hogs, horses, and sheep

                                     0.01

                                      1.2

                                     0.012

Fat of cattle, goats, hogs, horses, and sheep

                                     0.01

                                       -

                                     0.01

Liver of cattle, goats, horses, sheep

                                      1.0

                                       -

                                      1.0

Meat Byproducts (except liver) of cattle, goats, horses, and sheep

                                      0.1

                                      1.2

                                     0.12

Hog liver

                                      0.1

                                       -

                                      0.1

Meat Byproducts (except liver) of hogs

                                     0.01

                                      1.2

                                     0.012

Poultry liver

                                     0.01

                                      1.8

                                     0.018
 

III.   Percent Crop Treated Information

The acute and chronic assessments were both based on the assumption that 100% of all commodities with amicarbazone tolerances will be treated.

IV.   Drinking Water Data

The estimated drinking water concentrations (EDWCs) used in the dietary risk assessments were provided by the Environmental Fate and Effects Division (EFED; D384659, A. Shelby, 9/7/2011).  The EDWCs are incorporated directly into this dietary assessment into the food categories "water, direct, all sources" and "water, indirect, all sources."  The residues of concern in drinking water for risk assessment are parent amicarbazone and its des-amino and N-methyl des-amino degradates.  The surface water and groundwater estimates were calculated using the PRZM/EXAMS and SCI-GROW Models, respectively.  The EDWCs given in Table 2 are the total toxic residues of amicarbazone, which include the des-amino and N-methyl des-amino degradates as well as unextracted residues.  The EDWCs represent upper-bound estimates that might be found in surface water and groundwater as a result of the application of amicarbazone on turf and conifers one time at the maximum yearly rate (worst case scenario).  

The groundwater estimate of 136 ppb was used for both the acute and chronic assessments because it was higher than all of the surface water values.  For more information about EFED's drinking water models, see http://www.epa.gov/oppefed1/models/water/).

Table 2.  Amicarbazone EDWCs Determined Using the PRZM/EXAMS and SCI-GROW Models 
  

                                   Chemical
                           Surface water EDWCs (ppb)
                                  Groundwater
                           Acute/Chronic EDWC (ppb)
                                       
                             Peak 96 hour average
                              Peak annual average

30 Year Average

                     Total Toxic Residues of amicarbazone
                                       
                                     33.3
                                       
                                     25.8
                                       
                                     11.1
                                       
                                      136

EDWCs would be reduced if degradates were not assumed to be of equal toxicity as parent amicarbazone or if unextracted residues were determined to be bound residues.  Exclusion of degradates and bound residue results in reduction of EDWCs by as much as 70%.  Exclusion of bound residues results in reduction of EDWCs by as much as 20%.  

V.   DEEM-FCID(TM) Program and Consumption Information

Amicarbazone acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-

FCID(TM),Version 2.03 which incorporates consumption data from USDA's CSFII, 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or "matched" in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

VI.   Toxicological Information

Adequate data have been submitted to characterize the toxicity of amicarbazone for the purposes of dietary risk assessment.  Acute and chronic dietary endpoints were selected for the general U.S. population and all population subgroups including those comprised of infants and children.  The toxicological doses and endpoints selected for human health risk assessment are summarized in Table 3, below.  The FQPA Safety Factor was reduced to 1x.  Amicarbazone is classified as "not likely to be a human carcinogen."  

Table 3.  Summary of Toxicological Doses and Endpoints for Amicarbazone for Use in Dietary Human Health Risk Assessments
                              Exposure/ Scenario
                              Point of Departure
                        Uncertainty/FQPA Safety Factors
                RfD, PAD, Level of Concern for Risk Assessment
                        Study and Toxicological Effects
Acute Dietary (General Population, including Infants and Children and Females 13-49 years of age)
NOAEL= 10 mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x

Acute RfD = 0.10 mg/kg/day

aPAD =0.10 mg/kg/day
Acute Oral Neurotoxicity Screening Battery

LOAEL = 20 mg/kg/day based on eyelid ptosis, decreased approach response and red nasal staining in females
Chronic Dietary (General Population, including Infants and Children and Females 13-49 years of age)
NOAEL= 2.3 mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x

Chronic RfD = 0.023
mg/kg/day

cPAD = 0.023 mg/kg/day
Chronic Oral Rat and Chronic Oral Dog (co-critical)

Rat LOAEL = 25.3 mg/kg/day based on decreased body weight and weight gain
Dog LOAEL = 8.7 mg/kg/day based on liver effects, including increased absolute/relative liver weights, triglycerides and cholesterol 
Cancer (oral, dermal, inhalation)
Classification:  There was no treatment-related increase in tumor incidence when compared to control.  Dosing was considered adequate.  This chemical is not likely to be a carcinogen.
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 (a = acute, c = chronic).  RfD = reference dose.

VII.   Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID(TM) analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 5 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  Risk estimates are below HED's level of concern for all population subgroups in both the acute and chronic analyses.  The acute risk estimate for the general U.S. population is 8.8% of the aPAD.  The population subgroup with the highest acute risk estimate is All Infants, which uses 29% of the aPAD.  The chronic risk estimate for the general U.S. population is 17% of the cPAD.  The most highly exposed population subgroup is All Infants, which uses 48% of the cPAD.  As amicarbazone is not likely to be a human carcinogen, a dietary exposure assessment for the purpose of assessing cancer risk is not necessary.

 
 Full listings of exposure and risk estimates are included in Attachments 2 (acute analysis) and 3 (chronic analysis).
 
 
 Table 4.  Summary of Acute and Chronic Dietary (Food and Drinking Water) Exposure and Risk Estimates for Amicarbazone 
 
 Population Subgroup
                      Acute Assessment (95[th] Percentile)
                               Chronic Assessment
 
                                  aPAD, mg/day
                           Exposure Estimate, mg/day
                                     % aPad
                                  cPAD, mg/day
                           Exposure Estimate, mg/day
                                     % cPad
U.S. Population
0.10
0.008807
                                      8.8
                                     0.023
0.003889
17
All infants
0.10
0.029429
                                      29
                                     0.023
0.010987
48
Children 1-2 yrs
0.10
0.014750
                                      15
                                     0.023
0.006921
30
Children 3-5 yrs
0.10
0.013469
                                      13
                                     0.023
0.006474
28
Children 6-12 yrs
0.10
0.009356
                                      9.4
                                     0.023
0.004469
19
Youth 13-19 yrs
0.10
0.006999
                                      7.0
                                     0.023
0.003120
14
Adults 20-49 yrs
0.10
0.007621
                                      7.6
                                     0.023
0.003472
15
Adults 50+ yrs
0.10
0.006711
                                      6.7
                                     0.023
0.003441
15
Females 13-49 yrs
0.10
0.007603
                                      7.6
                                     0.023
0.003431
15
 
 
 As drinking water is a major contributor to dietary risk for the general U.S. population and all population subgroups, commodity contribution analyses were performed to determine the contribution of drinking water to the total dietary exposure estimates.  In the acute analyses, drinking water contributed between 76% and 90% of the total exposure.  In the chronic analyses, drinking water contributed between 62% and 86% of the total exposure.  The results of the analyses are given in Table 5, below.
 
  
 
 Table 5.  Contribution of Residues in Drinking Water to Total Dietary Exposure 
 
 Population Subgroup
                                Acute Assessment
                          % of Total Dietary Exposure
                               Chronic Assessment
                          % of Total Dietary Exposure
U.S. Population
                                      80
                                      74
All infants
                                      90
                                      86
Children 1-2 yrs
                                      74
                                      62
Children 3-5 yrs
                                      76
                                      62
Children 6-12 yrs
                                      76
                                      62
Youth 13-19 yrs
                                      85
                                      66
Adults 20-49 yrs
                                      88
                                      77
Adults 50+ yrs
                                      90
                                      82
Females 13-49 yrs
                                      89
                                      78
 
 
 
 
 
 VIII.   Characterization of Inputs/Outputs
 
HED considers both the acute and chronic assessments to be very conservative.  For amicarbazone, drinking water is the greatest contributor to dietary exposure and risk.  The EDWCs represent upper-bound estimates that might be found in surface water and groundwater as a result of the application of amicarbazone on turf and conifers one time at the maximum yearly rate (worst case scenario).  The EDWCs would be reduced if degradates were not assumed to be of equal toxicity as parent amicarbazone or if unextracted residues were determined to be bound residues.  Exclusion of degradates and bound residue results in reduction of EDWCs by as much as 70%.  Exclusion of bound residues results in reduction of EDWCs by as much as 20%.  
  
Although food commodities do not contribute significantly to the total dietary exposure, minor reductions in the exposure and risk estimates could be made through the use of refinements.  The assessments are based on tolerance-level residues for all commodities.  Conservative processing factors were used for all processed commodities for which they were available.  In addition, it is assumed that 100% of all crops with registered uses of amicarbazone are treated.  Further refinements to these analyses could be made through the use of anticipated residues (e.g., distributions of field trial data for the acute assessment and average field trial values for the chronic assessment) and percent crop treated estimates.  However, as all risk estimates are not of concern, it is not necessary to make any refinements to the dietary exposure assessments.  
 
 
 IX.   Conclusions
 
The exposure estimates that were generated are very conservative estimates of the actual dietary exposures that might occur.  The aggregate (food + water) dietary risk estimates are below HED's level of concern for all population subgroups for both the acute and chronic exposure scenarios.  HED is confident that the acute and chronic dietary exposure assessments do not underestimate risk to the general U.S. population or any population subgroup.
 
 
 X.   List of Attachments
 
Attachment 1.  Acute and Chronic Dietary Residue Input File for Amicarbazone
Attachment 2.  Results of Acute Dietary Exposure Assessment
 Attachment 3.  Results of Chronic Dietary Exposure Assessment
 

Attachment 1:  Acute and Chronic Dietary Residue Input File for Amicarbazone

DEEM FCID Version 2.03

Acute NOAEL for general population and all population subgroups:  10 mg/kg bw/day
Acute PAD for general population and all population subgroups:  0.10 mg/kg bw/day

Chronic NOAEL for general population and all population subgroups:  2.3 mg/kg bw/day
Chronic PAD for general population and all population subgroups:  0.023 mg/kg bw/day

Filename: C:\Documents and Settings\ddotson\My Documents\Deemfcid\ Amicarbazone\Amicarbazone2011.R98

Date created/last modified: 10-01-2011/14:33:04/8

--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code    Grp  Commodity Name                    (ppm)       #1    #2   
-------- ---- -------------------------------  ----------  ------ ------  -------
06003470 6    Soybean, seed                      0.800000   1.000  1.000  
06003480 6    Soybean, flour                     0.800000   1.000  1.000  
06003481 6    Soybean, flour-babyfood            0.800000   1.000  1.000  
06003490 6    Soybean, soy milk                  0.800000   1.000  1.000  
06003491 6    Soybean, soy milk-babyfood or in   0.800000   1.000  1.000  
06003500 6    Soybean, oil                       0.800000   1.000  1.000  
06003501 6    Soybean, oil-babyfood              0.800000   1.000  1.000  
15001200 15   Corn, field, flour                 0.050000   1.000  1.000  
15001201 15   Corn, field, flour-babyfood        0.050000   1.000  1.000  
15001210 15   Corn, field, meal                  0.050000   1.000  1.000  
15001211 15   Corn, field, meal-babyfood         0.050000   1.000  1.000  
15001220 15   Corn, field, bran                  0.050000   1.000  1.000  
15001230 15   Corn, field, starch                0.050000   1.000  1.000  
15001231 15   Corn, field, starch-babyfood       0.050000   1.000  1.000  
15001240 15   Corn, field, syrup                 0.050000   1.500  1.000  
15001241 15   Corn, field, syrup-babyfood        0.050000   1.500  1.000  
15001250 15   Corn, field, oil                   0.050000   1.000  1.000  
15001251 15   Corn, field, oil-babyfood          0.050000   1.000  1.000  
15004010 15   Wheat, grain                       0.170000   1.000  1.000  
15004011 15   Wheat, grain-babyfood              0.170000   1.000  1.000  
15004020 15   Wheat, flour                       0.255000   1.000  1.000  
15004021 15   Wheat, flour-babyfood              0.255000   1.000  1.000  
15004030 15   Wheat, germ                        0.255000   1.000  1.000  
15004040 15   Wheat, bran                        0.255000   1.000  1.000  
21000440 M    Beef, meat                         0.012000   1.000  1.000  
21000441 M    Beef, meat-babyfood                0.012000   1.000  1.000  
21000450 M    Beef, meat, dried                  0.012000   1.920  1.000  
21000460 M    Beef, meat byproducts              0.120000   1.000  1.000  
21000461 M    Beef, meat byproducts-babyfood     0.120000   1.000  1.000  
21000470 M    Beef, fat                          0.010000   1.000  1.000  
21000471 M    Beef,fat-babyfood                  0.010000   1.000  1.000  
21000480 M    Beef, kidney                       0.120000   1.000  1.000  
21000490 M    Beef, liver                        1.000000   1.000  1.000  
21000491 M    Beef, liver-babyfood               1.000000   1.000  1.000  
23001690 M    Goat, meat                         0.012000   1.000  1.000  
23001700 M    Goat, meat byproducts              0.120000   1.000  1.000  
23001710 M    Goat, fat                          0.010000   1.000  1.000  
23001720 M    Goat, kidney                       0.120000   1.000  1.000  
23001730 M    Goat, liver                        1.000000   1.000  1.000  
24001890 M    Horse, meat                        0.012000   1.000  1.000  
25002900 M    Pork, meat                         0.012000   1.000  1.000  
25002901 M    Pork, meat-babyfood                0.012000   1.000  1.000  
25002910 M    Pork, skin                         0.012000   1.000  1.000  
25002920 M    Pork, meat byproducts              0.012000   1.000  1.000  
25002921 M    Pork, meat byproducts-babyfood     0.012000   1.000  1.000  
25002930 M    Pork, fat                          0.010000   1.000  1.000  
25002931 M    Pork, fat-babyfood                 0.010000   1.000  1.000  
25002940 M    Pork, kidney                       0.012000   1.000  1.000  
25002950 M    Pork, liver                        0.100000   1.000  1.000  
26003390 M    Sheep, meat                        0.012000   1.000  1.000  
26003391 M    Sheep, meat-babyfood               0.012000   1.000  1.000  
26003400 M    Sheep, meat byproducts             0.120000   1.000  1.000  
26003410 M    Sheep, fat                         0.010000   1.000  1.000  
26003411 M    Sheep, fat-babyfood                0.010000   1.000  1.000  
26003420 M    Sheep, kidney                      0.120000   1.000  1.000  
26003430 M    Sheep, liver                       1.000000   1.000  1.000  
27002220 D    Milk, fat                          0.016000   1.000  1.000  
27002221 D    Milk, fat - baby food/infant for   0.016000   1.000  1.000  
27012230 D    Milk, nonfat solids                0.016000   1.000  1.000  
27012231 D    Milk, nonfat solids-baby food/in   0.016000   1.000  1.000  
27022240 D    Milk, water                        0.016000   1.000  1.000  
27022241 D    Milk, water-babyfood/infant form   0.016000   1.000  1.000  
27032251 D    Milk, sugar (lactose)-baby food/   0.016000   1.000  1.000  
40000940 P    Chicken, liver                     0.018000   1.000  1.000  
50003830 P    Turkey, liver                      0.018000   1.000  1.000  
60003020 P    Poultry, other, liver              0.018000   1.000  1.000  
86010000 O    Water, direct, all sources         0.136000   1.000  1.000  
86020000 O    Water, indirect, all sources       0.136000   1.000  1.000  
95001280 O    Cottonseed, oil                    0.070000   1.000  1.000  
95001281 O    Cottonseed, oil-babyfood           0.070000   1.000  1.000  

Attachment 2:  Results of Acute Dietary Exposure Assessment

Residue file: Amicarbazone2011.R98 
Analysis Date: 10-01-2011/14:39:50    
Residue file dated: 10-01-2011/14:33:04/8
Daily totals for food and foodform consumption used.

===============================================================================

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile
 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE  
---------- ------- -------- ---------- ------- -------- ---------- ------- --------
U.S. Population:
  0.008807    8.81    1135    0.015320   15.32     652    0.029257   29.26     341  
All infants:
  0.029429   29.43     339    0.042121   42.12     237    0.071274   71.27     140  
Children 1-2 yrs:
  0.014750   14.75     677    0.023625   23.62     423    0.041600   41.60     240  
Children 3-5 yrs:
  0.013469   13.47     742    0.019734   19.73     506    0.035375   35.37     282  
Children 6-12 yrs:
  0.009356    9.36    1068    0.014263   14.26     701    0.019715   19.72     507  
Youth 13-19 yrs:
  0.006999    7.00    1428    0.010993   10.99     909    0.018113   18.11     552  
Adults 20-49 yrs:
  0.007621    7.62    1312    0.012089   12.09     827    0.020763   20.76     481  
Adults 50+ yrs:
  0.006711    6.71    1490    0.009375    9.38    1066    0.015091   15.09     662  
Females 13-49 yrs:
  0.007603    7.60    1315    0.011946   11.95     837    0.019959   19.96     501  

Attachment 3:  Results of Chronic Dietary Exposure Assessment

Residue file name: C:\Documents and Settings\ddotson\My Documents\Deemfcid\ Amicarbazone\Amicarbazone2011.R98
Residue file dated:  10-01-2011/14:33:04/8
Analysis Date:  10-01-2011/14:42:17

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

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ---------------
U.S. Population (total)                     0.003889                16.9%

U.S. Population (spring season)             0.003870                16.8%
U.S. Population (summer season)             0.004080                17.7%
U.S. Population (autumn season)             0.003802                16.5%
U.S. Population (winter season)             0.003802                16.5%

Northeast region                            0.003623                15.8%
Midwest region                              0.003978                17.3%
Southern region                             0.003704                16.1%
Western region                              0.004327                18.8%

Hispanics                                   0.004292                18.7%
Non-hispanic whites                         0.003811                16.6%
Non-hispanic blacks                         0.003751                16.3%
Non-hisp/non-white/non-black                0.004624                20.1%

All infants (< 1 year)                      0.010987                47.8%
Nursing infants                             0.004012                17.4%
Non-nursing infants                         0.013634                59.3%
Children 1-6 yrs                            0.006499                28.3%
Children 7-12 yrs                           0.004243                18.4%

Females 13-19 (not preg or nursing)         0.002931                12.7%
Females 20+ (not preg or nursing)           0.003535                15.4%
Females 13-50 yrs                           0.003588                15.6%
Females 13+ (preg/not nursing)              0.003671                16.0%
Females 13+ (nursing)                       0.004902                21.3%

Males 13-19 yrs                             0.003284                14.3%
Males 20+ yrs                               0.003361                14.6%
Seniors 55+                                 0.003431                14.9%

Children 1-2 yrs                            0.006921                30.1%
Children 3-5 yrs                            0.006474                28.1%
Children 6-12 yrs                           0.004469                19.4%
Youth 13-19 yrs                             0.003120                13.6%
Adults 20-49 yrs                            0.003472                15.1%
Adults 50+ yrs                              0.003441                15.0%
Females 13-49 yrs                           0.003431                14.9%

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