Document ID: EPA-HQ-OPP-2012-0706-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-11-27T05:00Z

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

MEMORANDUM

Date:		23-MAY-2013 

SUBJECT:	Metaldehyde.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to Support New Uses on Corn [Field and Sweet], Crop Subgroup 13-07A [Caneberry Subgroup], Crop Subgroup 13-07B [Bushberry Subgroup], Crop Subgroup 13-07G [Low-growing Berry Subgroup], Grass, Mint, Soybean, and Taro.   
 
PC Code:   053001
DP Barcode:  D408746
Decision No.:  468286
Registration No.:  NA
Petition No.:  2E8070
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  Dietary Aggregate Risk
Case No.:  NA
TXR No.:  NA
CAS No.:  108-62-3
MRID No.:  NA
40 CFR:  §180.523

FROM:	William H. Donovan, Ph.D., Chemist
		Risk Assessment Branch V
		Health Effects Division (7509P)

THROUGH:	Douglas Dotson, Ph.D., Chemist 
		Thurston Morton, Chemist	
		Dietary Exposure Science Advisory Council (DESAC)
		HED (7509P)	
		
		

TO:		Matthew Lloyd, Risk Assessor
		RAB VII 
		HED (7509P)	

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model with the Food Commodity Intake Database (DEEM-FCID) Version 3.16.  This software incorporates 2003-2008 food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  The analyses were performed to support Section 3 registration requests for uses on corn [field and sweet], Crop Subgroup 13-07A [Caneberry Subgroup], Crop Subgroup 13-07B [Bushberry Subgroup], Crop Subgroup 13-07G [Low-growing Berry Subgroup], grass, mint, soybean, and taro.  This memo was reviewed by two members of the DESAC, per the current DESAC SOP.

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization
A conservative acute dietary assessment was conducted using tolerance-level residues, 100% crop treated assumptions, and modeled water numbers.  At the 95[th] percentile of exposure, the estimated risk is <=99% of the acute population adjusted dose (aPAD) for the U.S. population and all population subgroups.  

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization
A conservative chronic dietary assessment was conducted using tolerance-level residues, 100% crop treated assumptions, and modeled water numbers.  The estimated risk is <=36% of the chronic population adjusted dose (cPAD) for the U.S. population and all population subgroups.

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 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 most recent dietary risk assessment for metaldehyde was conducted by F. Fort (D323514, 21-DEC-2005).  

II.  Residue Information

Tolerances for metaldehyde are established under 40 CFR §180.523, see Table 1.  The residue of concern in plants consists of the parent compound.  

Table 1.  Established Metaldehyde Tolerances
Commodity
Parts Per Million
Artichoke, globe
0.07
Berry group 13
0.15
Cactus
0.07
Fruit, citrus, group 10
0.26
Lettuce
1.73
Strawberry
6.25
Tomato
0.24
Vegetable, brassica, leafy, group 5
2.5
Watercress
3.2

Requirements for animal metabolism and feeding studies have been waived.  The Agency concluded that residues are unlikely to occur in livestock commodities based upon the rapid degradation of metaldehyde in mammalian systems and the subsequent incorporation of degradates into naturally occurring components.  

The recommended tolerances for metaldehyde for the current action are shown in Table 2 (D408745, W. Donovan, in preparation).  
Table 2. 	Tolerance Summary for Metaldehyde.
Commodity
                           Proposed Tolerance (ppm)
                          Recommended Tolerance (ppm)
Comments; Correct Commodity Definition
Leaf petioles subgroup 4B
                                     0.80
                                     0.50

Peppermint, tops
                                      3.5
                                      4.0

Spearmint, tops
                                      3.5
                                      4.0

Peppermint, oil
                                      14
                                      12

Spearmint, oil
                                      14
                                      12

Caneberry subgroup 13-07A
                                     0.15
                                     0.15

Bushberry subgroup 13-07B
                                     0.15
                                     0.15

Berry, low growing, subgroup 13-07G
                                     6.25
                                     6.25

Taro, corm
                                     0.25
                                     0.15

Taro, leaves
                                     0.60
                                      1.0

Corn, field, grain
                                     0.05
                                     0.05

Corn, sweet, kernel plus cob with husks removed
                                     0.05
                                     0.05

Soybean, seed
                                     0.05
                                     0.05

Grass, forage
                                      1.5
                                      2.0

Grass, hay
                                      1.8
                                      2.0

Corn, field, forage
                                     0.25
                                     0.30

Corn, field, stover
                                     0.15
                                     0.10

                      Tolerances that need to be proposed
Corn, sweet, forage
                                     None
                                     0.30

Corn, sweet, stover
                                     None
                                     0.10

The representative commodities for Berry group 13 were raspberry or blackberry, and blueberry.  The tolerance for Berry group 13 was based on these berry commodities.  The berry crop group has been expanded since a Federal Register notice dated December 7, 2007.  Raspberry or blackberry is now the representative commodity for Caneberry subgroup 13-07A; thus data previously submitted on raspberry or blackberry support a new tolerance for this subgroup.  Blueberry is now the representative commodity for Bushberry subgroup 13-07B; thus data previously submitted on blueberry support a new tolerance for this subgroup.  Strawberry is now the representative commodity for Berry, low growing, subgroup 13-07G; thus data previously submitted on strawberry support a new tolerance for this subgroup.  
DEEM does not have a listing for taro.  However, dasheen is a variety of taro that is included in DEEM and the recommended tolerances for taro, corm and taro, leaves were included in the analyses as dasheen, corm and dasheen, leaves, respectively.

For all dietary risk assessments, the established and recommended tolerances were used and 100% crop treated was assumed.  Processing studies for tomatoes and oranges indicate that metaldehyde residues do not concentrate in processed commodities derived from these crops. The orange juice processing factor was extrapolated to other citrus juices.  Exaggerated rates studies in corn and soybean showed no detectable grain or seed residues at rates of 5x and 10x, respectively.  Therefore, no processing factors were used in the analyses except for those processed commodities for which no processing studies are typically conducted (tomato, dried; tomato, juice; cranberry, juice; and high fructose corn syrup), for which default factors were used.

The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010.  In general, pesticide residues would not be expected to be found in fish unless the pesticide bio accumulates or has an aquatic use.  To determine whether or not residues are present in fish, HED now routinely checks PDP monitoring data regardless of the pesticide's uses and physicochemical properties.  However, PDP did not analyze catfish samples for metaldehyde.  As a result, residues in fish were not included in the assessment.

III.  Percent Crop Treated Information

The acute and chronic assessments assumed 100% crop treated for all registered and proposed new use crops.

IV.  Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED): email message from M. Biscoe to W. Donovan, 21-MAY-2013.   Water residues were incorporated in the DEEM-FCID into the food categories "water, direct, all sources" and "water, indirect, all sources."   

There are no monitoring data currently available for metaldehyde in drinking water.  Estimated drinking water concentrations (EDWCs) were generated using computer modeling procedures.  The highest EDWCs resulted from the special mollusk eradication use on turf, and these values were used in the present dietary analysis.  Surface water estimates were determined using the PRZM-EXAMS model and ground water estimates were determined using the PRZM-GW model.  These latter values were recommended for use in the human-health dietary risk assessment as they were the highest values obtained.   Additional information concerning the water models is available at the EPA internet site: http://www.epa.gov/pesticides/science/models_pg.htm#aquatic.

Maximum application rates for metaldehyde as a high-end estimate of exposure in drinking water were modeled based on the proposed labels.  Chemical specific and model input values were chosen in accordance with current EFED input parameter guidance (USEPA, 2009). The maximum surface and ground water EDWCs for use in the human-health risk assessment for metaldehyde are shown in Table 3.  

Table 3. Maximum Tier II estimated drinking water concentrations (EDWCs) in parts per billion (μg/L) resulting from 6 applications of 2 lb a.i./acre of metaldehyde to turf with a reapplication interval of 14 days.
Drinking water source (model)
                                 1-in-10 year 
                              30-year simulation

                                     Acute
                                    Chronic
                                     Acute
                                    Chronic
Surface water    (PRZM-EXAMS)
                                      205
                                      136
                                       -
                                      83
Ground water     (PRZM-GW)
                                       -
                                       -
                                     1740
                                      635

Recommended for use in Risk Assessment: 1740 ppb acute value, 635 ppb chronic value

V.  DEEM-FCID Program and Consumption Information

Metaldehyde acute and chronic dietary exposure assessments were conducted using the DEEM-FCID, Version 3.16, which incorporates 2003-2008 food consumption data from USDA's NHANES/WWEIA.  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.

For an acute exposure assessment, 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 analyses performed at all levels of refinement.  However, for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

VI.  Toxicological Information
	
The Metaldehyde risk assessment team in consultation with the ToxSAC (Toxicology Science Advisory Council) selected doses and endpoints for risk assessment.  The toxicological doses and endpoints used for dietary risk assessment are summarized in Table 4.
Table 4.   Summary of Toxicological Doses and Endpoints for Metaldehyde 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 (All Populations)
NOAEL = 30 mg/kg/day
UFA 10x
UFH 10x

FQPA SF = 1X
aRfD = 0.30 mg/kg/day

aPAD = 0.30 mg/kg/day
Chronic dog oral toxicity study
LOAEL = 90 mg/kg/day, based on clinical signs (ataxia, tremor, salivation, twitching) seen on day 1 of dosing (both sexes).
Chronic Dietary (All Populations)
NOAEL = 10 mg/kg/day
UFA 10x
UFH 10x

FQPA SF = 1X
cRfD = 0.10 mg/kg/day

cPAD = 0.10 mg/kg/day
Chronic dog oral toxicity study
LOAEL = 30 mg/kg/day, based on death and atrophy of the testes and prostate
Cancer 
Classification:  Suggestive Evidence of Carcinogenicity; EPA has determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity.
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 (intraspecies).  UFH = potential variation in sensitivity among members of the human population (interspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.  

The Agency recommends that the 10X FQPA safety factor for the protection of infants and children, be reduced to 1X.  The risk assessments conducted for metaldehyde were based on the most sensitive endpoints in the toxicity database, and the NOAELs selected for risk assessment are considered protective of potential developmental, neurotoxic, and immunotoxic effects for infants and children.  Highly conservative exposure estimates were incorporated into the risk assessment for metaldehyde.  There are no residual uncertainties with regard to pre- and/or postnatal toxicity, neurotoxicity, or exposure; therefore, reduction of the 10X FQPA safety factor to 1X is appropriate.

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 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 50-99 years.  

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis
A conservative acute dietary assessment was conducted using tolerance-level residues, 100% crop treated assumptions, and modeled water numbers.  At the 95[th] percentile of exposure, the estimated risk is <=99% of the acute population adjusted dose (aPAD) for the U.S. population and all population subgroups.  Results are shown in Table 5.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis 
A conservative chronic dietary assessment was conducted using tolerance-level residues, 100% crop treated assumptions, and modeled water numbers.  The estimated risk is <=36% of the chronic population adjusted dose (cPAD) for the U.S. population and all subpopulations.  Results are shown in Table 5.

 Table 5.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for Metaldehyde.[1]
                              Population Subgroup
                                 Acute Dietary
                               (95th Percentile)
                                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
                                    0.099762
                                       33
                                    0.016044
                                       16
                                      N/A
                                      N/A
 All Infants (< 1 year old)
                                    0.298300
                                       99
                                    0.036060
                                       36
                                        
                                        
 Children 1-2 years old
                                    0.162635
                                       54
                                    0.026927
                                       27
                                        
                                        
 Children 3-5 years old
                                    0.129865
                                       43
                                    0.022145
                                       22
                                        
                                        
 Children 6-12 years old
                                    0.095292
                                       32
                                    0.015210
                                       15
                                        
                                        
 Youth 13-19 years old
                                    0.082308
                                       27
                                    0.011935
                                       12
                                        
                                        
 Adults 20-49 years old
                                    0.096014
                                       32
                                    0.015495
                                       15
                                        
                                        
 Adults 50-99 years old
                                    0.087204
                                       29
                                    0.015637
                                       16
                                        
                                        
 Females 13-49 years old
                                    0.098577
                                       33
                                    0.015638
                                       16
                                        
                                        
 [1]	Highest exposure identified in bold.

 VIII.  Characterization of Inputs/Outputs

The HED has conducted highly conservative acute and chronic dietary risk assessments.  These assessments could be refined using highest and mean residue levels instead of tolerance level residues and/or percent crop treated data.  However, since risks were not of concern, no refinements were conducted other than the use of refined estimates for drinking water concentrations.  

 IX.  Conclusions

The HED conducted acute and chronic dietary risk assessments which incorporated tolerance level residues, 100% crop treated assumptions, and modeled water numbers.  Acute and chronic dietary risks to all population subgroups were <=99% and <=36% of the aPAD and cPAD, respectively.   HED is confident that these assessments do not underestimate risk to the general U.S. population or any population subgroup.

 X.  List of Attachments
 
Attachment 1.  Acute Residue Input File
Attachment 2.  Acute Results File
Attachment 3.  Chronic Residue Input File
Attachment 4.  Chronic Results File
                    Attachment 1.  Acute Residue Input File
                                       
Filename: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 3.16\053001a.R08
Chemical: Metaldehyde
RfD(Chronic): .1 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .3 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 05-22-2013/07:29:28       Program ver. 3.16, 03-08-d
Comment: metaldehyde food and water (PRZM-GW model) acute
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2   
---------- ---- -------------------------------  ----------  ------ ------  -------
0103139000 1CD  Dasheen, corm                      0.150000   1.000  1.000  
0200140000 2    Dasheen, leaves                    1.000000   1.000  1.000  
0401204000 4A   Lettuce, head                      1.730000   1.000  1.000  
0401205000 4A   Lettuce, leaf                      1.730000   1.000  1.000  
0402076000 4B   Cardoon                            0.500000   1.000  1.000  
0402085000 4B   Celery                             0.500000   1.000  1.000  
0402085001 4B   Celery-babyfood                    0.500000   1.000  1.000  
0402086000 4B   Celery, juice                      0.500000   1.000  1.000  
0402087000 4B   Celtuce                            0.500000   1.000  1.000  
0402152000 4B   Fennel, Florence                   0.500000   1.000  1.000  
0402322000 4B   Rhubarb                            0.500000   1.000  1.000  
0402367000 4B   Swiss chard                        0.500000   1.000  1.000  
0501061000 5A   Broccoli                           2.500000   1.000  1.000  
0501061001 5A   Broccoli-babyfood                  2.500000   1.000  1.000  
0501062000 5A   Broccoli, Chinese                  2.500000   1.000  1.000  
0501064000 5A   Brussels sprouts                   2.500000   1.000  1.000  
0501069000 5A   Cabbage                            2.500000   1.000  1.000  
0501071000 5A   Cabbage, Chinese, napa             2.500000   1.000  1.000  
0501072000 5A   Cabbage, Chinese, mustard          2.500000   1.000  1.000  
0501083000 5A   Cauliflower                        2.500000   1.000  1.000  
0501196000 5A   Kohlrabi                           2.500000   1.000  1.000  
0502063000 5B   Broccoli raab                      2.500000   1.000  1.000  
0502070000 5B   Cabbage, Chinese, bok choy         2.500000   1.000  1.000  
0502117000 5B   Collards                           2.500000   1.000  1.000  
0502194000 5B   Kale                               2.500000   1.000  1.000  
0502229000 5B   Mustard greens                     2.500000   1.000  1.000  
0502318000 5B   Rape greens                        2.500000   1.000  1.000  
0502389000 5B   Turnip, greens                     2.500000   1.000  1.000  
0600347000 6    Soybean, seed                      0.050000   1.000  1.000  
0600349000 6    Soybean, soy milk                  0.050000   1.000  1.000  
0600349001 6    Soybean, soy milk-babyfood or in   0.050000   1.000  1.000  
0600350000 6    Soybean, oil                       0.050000   1.000  1.000  
0600350001 6    Soybean, oil-babyfood              0.050000   1.000  1.000  
0601349500 6AB  Soybean, vegetable                 0.050000   1.000  1.000  
0603348000 6C   Soybean, flour                     0.050000   1.000  1.000  
0603348001 6C   Soybean, flour-babyfood            0.050000   1.000  1.000  
0801375000 8A   Tomato                             0.240000   1.000  1.000  
0801375001 8A   Tomato-babyfood                    0.240000   1.000  1.000  
0801376000 8A   Tomato, paste                      0.240000   1.000  1.000  
0801376001 8A   Tomato, paste-babyfood             0.240000   1.000  1.000  
0801377000 8A   Tomato, puree                      0.240000   1.000  1.000  
0801377001 8A   Tomato, puree-babyfood             0.240000   1.000  1.000  
0801378000 8A   Tomato, dried                      0.240000  14.300  1.000  
0801378001 8A   Tomato, dried-babyfood             0.240000  14.300  1.000  
0801379000 8A   Tomato, juice                      0.240000   1.500  1.000  
0801380000 8A   Tomato, Tree                       0.240000   1.000  1.000  
1001106000 10A  Citron                             0.260000   1.000  1.000  
1001107000 10A  Citrus hybrids                     0.260000   1.000  1.000  
1001108000 10A  Citrus, oil                        0.260000   1.000  1.000  
1001240000 10A  Orange                             0.260000   1.000  1.000  
1001241000 10A  Orange, juice                      0.260000   1.000  1.000  
1001241001 10A  Orange, juice-babyfood             0.260000   1.000  1.000  
1001242000 10A  Orange, peel                       0.260000   1.000  1.000  
1001369000 10A  Tangerine                          0.260000   1.000  1.000  
1001370000 10A  Tangerine, juice                   0.260000   1.000  1.000  
1002197000 10B  Kumquat                            0.260000   1.000  1.000  
1002199000 10B  Lemon                              0.260000   1.000  1.000  
1002200000 10B  Lemon, juice                       0.260000   1.000  1.000  
1002200001 10B  Lemon, juice-babyfood              0.260000   1.000  1.000  
1002201000 10B  Lemon, peel                        0.260000   1.000  1.000  
1002206000 10B  Lime                               0.260000   1.000  1.000  
1002207000 10B  Lime, juice                        0.260000   1.000  1.000  
1002207001 10B  Lime, juice-babyfood               0.260000   1.000  1.000  
1003180000 10C  Grapefruit                         0.260000   1.000  1.000  
1003181000 10C  Grapefruit, juice                  0.260000   1.000  1.000  
1003307000 10C  Pummelo                            0.260000   1.000  1.000  
1301055000 13A  Blackberry                         0.150000   1.000  1.000  
1301056000 13A  Blackberry, juice                  0.150000   1.000  1.000  
1301056001 13A  Blackberry, juice-babyfood         0.150000   1.000  1.000  
1301058000 13A  Boysenberry                        0.150000   1.000  1.000  
1301208000 13A  Loganberry                         0.150000   1.000  1.000  
1301320000 13A  Raspberry                          0.150000   1.000  1.000  
1301320001 13A  Raspberry-babyfood                 0.150000   1.000  1.000  
1301321000 13A  Raspberry, juice                   0.150000   1.000  1.000  
1301321001 13A  Raspberry, juice-babyfood          0.150000   1.000  1.000  
1302057000 13B  Blueberry                          0.150000   1.000  1.000  
1302057001 13B  Blueberry-babyfood                 0.150000   1.000  1.000  
1302136000 13B  Currant                            0.150000   1.000  1.000  
1302137000 13B  Currant, dried                     0.150000   1.000  1.000  
1302149000 13B  Elderberry                         0.150000   1.000  1.000  
1302174000 13B  Gooseberry                         0.150000   1.000  1.000  
1302191000 13B  Huckleberry                        0.150000   1.000  1.000  
1307130000 13G  Cranberry                          6.250000   1.000  1.000  
1307130001 13G  Cranberry-babyfood                 6.250000   1.000  1.000  
1307131000 13G  Cranberry, dried                   6.250000   1.000  1.000  
1307132000 13G  Cranberry, juice                   6.250000   1.000  1.000  
1307132001 13G  Cranberry, juice-babyfood          6.250000   1.000  1.000  
1307359000 13G  Strawberry                         6.250000   1.000  1.000  
1307359001 13G  Strawberry-babyfood                6.250000   1.000  1.000  
1307360000 13G  Strawberry, juice                  6.250000   1.000  1.000  
1307360001 13G  Strawberry, juice-babyfood         6.250000   1.000  1.000  
1500120000 15   Corn, field, flour                 0.050000   1.000  1.000  
1500120001 15   Corn, field, flour-babyfood        0.050000   1.000  1.000  
1500121000 15   Corn, field, meal                  0.050000   1.000  1.000  
1500121001 15   Corn, field, meal-babyfood         0.050000   1.000  1.000  
1500122000 15   Corn, field, bran                  0.050000   1.000  1.000  
1500123000 15   Corn, field, starch                0.050000   1.000  1.000  
1500123001 15   Corn, field, starch-babyfood       0.050000   1.000  1.000  
1500124000 15   Corn, field, syrup                 0.050000   1.500  1.000  
1500124001 15   Corn, field, syrup-babyfood        0.050000   1.500  1.000  
1500125000 15   Corn, field, oil                   0.050000   1.000  1.000  
1500125001 15   Corn, field, oil-babyfood          0.050000   1.000  1.000  
1500127000 15   Corn, sweet                        0.050000   1.000  1.000  
1500127001 15   Corn, sweet-babyfood               0.050000   1.000  1.000  
8601000000 86A  Water, direct, all sources         1.740000   1.000  1.000  M. Bis
            Full comment: M. Biscoe, 21MAY13
8602000000 86B  Water, indirect, all sources       1.740000   1.000  1.000  M. Bis
            Full comment: M. Biscoe, 21MAY13
9500016000 O    Artichoke, globe                   0.070000   1.000  1.000  
9500073000 O    Cactus                             0.070000   1.000  1.000  
9500275000 O    Peppermint                         4.000000   1.000  1.000  
9500276000 O    Peppermint, oil                   12.000000   1.000  1.000  
9500352000 O    Spearmint                          4.000000   1.000  1.000  
9500353000 O    Spearmint, oil                    12.000000   1.000  1.000  
9500398000 O    Watercress                         3.200000   1.000  1.000  

                       Attachment 2.  Acute Results File
                                       

U.S. EPA                                                    Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for METALDEHYDE                 NHANES 2003-2008 2-Day
Residue file: 053001a.R08                         Adjustment factor #2 NOT used.
Analysis Date: 05-22-2013/07:39:17    Residue file dated: 05-22-2013/07:29:28
RAC/FF intake summed over 24 hours
Run Comment: "metaldehyde food and water (PRZM-GW model) acute"
===============================================================================

Summary calculations--per capita:

                   95th Percentile      99th Percentile     99.9th Percentile
                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD 
                  ---------- --------  ---------- --------  ---------- --------
Total US Population:
                    0.099762    33.25    0.162722    54.24    0.301145   100.38 
All Infants:
                    0.298300    99.43    0.440810   146.94    0.592326   197.44 
Children 1-2:
                    0.162635    54.21    0.241752    80.58    0.551827   183.94 
Children 3-5:
                    0.129865    43.29    0.186709    62.24    0.302914   100.97 
Children 6-12:
                    0.095292    31.76    0.152585    50.86    0.231521    77.17 
Youth 13-19:
                    0.082308    27.44    0.133614    44.54    0.196520    65.51 
Adults 20-49:
                    0.096014    32.00    0.142317    47.44    0.202881    67.63 
Adults 50-99:
                    0.087204    29.07    0.131003    43.67    0.199679    66.56 
Female 13-49:
                    0.098577    32.86    0.143783    47.93    0.196324    65.44 

                   Attachment 3.  Chronic Residue Input File
                                       
Filename: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 3.16\053001c.R08
Chemical: Metaldehyde
RfD(Chronic): .1 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .3 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 05-22-2013/07:38:09       Program ver. 3.16, 03-08-d
Comment: metaldehyde food and water (PRZM-GW) chronic
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2   
---------- ---- -------------------------------  ----------  ------ ------  -------
0103139000 1CD  Dasheen, corm                      0.150000   1.000  1.000  
0200140000 2    Dasheen, leaves                    1.000000   1.000  1.000  
0401204000 4A   Lettuce, head                      1.730000   1.000  1.000  
0401205000 4A   Lettuce, leaf                      1.730000   1.000  1.000  
0402076000 4B   Cardoon                            0.500000   1.000  1.000  
0402085000 4B   Celery                             0.500000   1.000  1.000  
0402085001 4B   Celery-babyfood                    0.500000   1.000  1.000  
0402086000 4B   Celery, juice                      0.500000   1.000  1.000  
0402087000 4B   Celtuce                            0.500000   1.000  1.000  
0402152000 4B   Fennel, Florence                   0.500000   1.000  1.000  
0402322000 4B   Rhubarb                            0.500000   1.000  1.000  
0402367000 4B   Swiss chard                        0.500000   1.000  1.000  
0501061000 5A   Broccoli                           2.500000   1.000  1.000  
0501061001 5A   Broccoli-babyfood                  2.500000   1.000  1.000  
0501062000 5A   Broccoli, Chinese                  2.500000   1.000  1.000  
0501064000 5A   Brussels sprouts                   2.500000   1.000  1.000  
0501069000 5A   Cabbage                            2.500000   1.000  1.000  
0501071000 5A   Cabbage, Chinese, napa             2.500000   1.000  1.000  
0501072000 5A   Cabbage, Chinese, mustard          2.500000   1.000  1.000  
0501083000 5A   Cauliflower                        2.500000   1.000  1.000  
0501196000 5A   Kohlrabi                           2.500000   1.000  1.000  
0502063000 5B   Broccoli raab                      2.500000   1.000  1.000  
0502070000 5B   Cabbage, Chinese, bok choy         2.500000   1.000  1.000  
0502117000 5B   Collards                           2.500000   1.000  1.000  
0502194000 5B   Kale                               2.500000   1.000  1.000  
0502229000 5B   Mustard greens                     2.500000   1.000  1.000  
0502318000 5B   Rape greens                        2.500000   1.000  1.000  
0502389000 5B   Turnip, greens                     2.500000   1.000  1.000  
0600347000 6    Soybean, seed                      0.050000   1.000  1.000  
0600349000 6    Soybean, soy milk                  0.050000   1.000  1.000  
0600349001 6    Soybean, soy milk-babyfood or in   0.050000   1.000  1.000  
0600350000 6    Soybean, oil                       0.050000   1.000  1.000  
0600350001 6    Soybean, oil-babyfood              0.050000   1.000  1.000  
0601349500 6AB  Soybean, vegetable                 0.050000   1.000  1.000  
0603348000 6C   Soybean, flour                     0.050000   1.000  1.000  
0603348001 6C   Soybean, flour-babyfood            0.050000   1.000  1.000  
0801375000 8A   Tomato                             0.240000   1.000  1.000  
0801375001 8A   Tomato-babyfood                    0.240000   1.000  1.000  
0801376000 8A   Tomato, paste                      0.240000   1.000  1.000  
0801376001 8A   Tomato, paste-babyfood             0.240000   1.000  1.000  
0801377000 8A   Tomato, puree                      0.240000   1.000  1.000  
0801377001 8A   Tomato, puree-babyfood             0.240000   1.000  1.000  
0801378000 8A   Tomato, dried                      0.240000  14.300  1.000  
0801378001 8A   Tomato, dried-babyfood             0.240000  14.300  1.000  
0801379000 8A   Tomato, juice                      0.240000   1.500  1.000  
0801380000 8A   Tomato, Tree                       0.240000   1.000  1.000  
1001106000 10A  Citron                             0.260000   1.000  1.000  
1001107000 10A  Citrus hybrids                     0.260000   1.000  1.000  
1001108000 10A  Citrus, oil                        0.260000   1.000  1.000  
1001240000 10A  Orange                             0.260000   1.000  1.000  
1001241000 10A  Orange, juice                      0.260000   1.000  1.000  
1001241001 10A  Orange, juice-babyfood             0.260000   1.000  1.000  
1001242000 10A  Orange, peel                       0.260000   1.000  1.000  
1001369000 10A  Tangerine                          0.260000   1.000  1.000  
1001370000 10A  Tangerine, juice                   0.260000   1.000  1.000  
1002197000 10B  Kumquat                            0.260000   1.000  1.000  
1002199000 10B  Lemon                              0.260000   1.000  1.000  
1002200000 10B  Lemon, juice                       0.260000   1.000  1.000  
1002200001 10B  Lemon, juice-babyfood              0.260000   1.000  1.000  
1002201000 10B  Lemon, peel                        0.260000   1.000  1.000  
1002206000 10B  Lime                               0.260000   1.000  1.000  
1002207000 10B  Lime, juice                        0.260000   1.000  1.000  
1002207001 10B  Lime, juice-babyfood               0.260000   1.000  1.000  
1003180000 10C  Grapefruit                         0.260000   1.000  1.000  
1003181000 10C  Grapefruit, juice                  0.260000   1.000  1.000  
1003307000 10C  Pummelo                            0.260000   1.000  1.000  
1301055000 13A  Blackberry                         0.150000   1.000  1.000  
1301056000 13A  Blackberry, juice                  0.150000   1.000  1.000  
1301056001 13A  Blackberry, juice-babyfood         0.150000   1.000  1.000  
1301058000 13A  Boysenberry                        0.150000   1.000  1.000  
1301208000 13A  Loganberry                         0.150000   1.000  1.000  
1301320000 13A  Raspberry                          0.150000   1.000  1.000  
1301320001 13A  Raspberry-babyfood                 0.150000   1.000  1.000  
1301321000 13A  Raspberry, juice                   0.150000   1.000  1.000  
1301321001 13A  Raspberry, juice-babyfood          0.150000   1.000  1.000  
1302057000 13B  Blueberry                          0.150000   1.000  1.000  
1302057001 13B  Blueberry-babyfood                 0.150000   1.000  1.000  
1302136000 13B  Currant                            0.150000   1.000  1.000  
1302137000 13B  Currant, dried                     0.150000   1.000  1.000  
1302149000 13B  Elderberry                         0.150000   1.000  1.000  
1302174000 13B  Gooseberry                         0.150000   1.000  1.000  
1302191000 13B  Huckleberry                        0.150000   1.000  1.000  
1307130000 13G  Cranberry                          6.250000   1.000  1.000  
1307130001 13G  Cranberry-babyfood                 6.250000   1.000  1.000  
1307131000 13G  Cranberry, dried                   6.250000   1.000  1.000  
1307132000 13G  Cranberry, juice                   6.250000   1.000  1.000  
1307132001 13G  Cranberry, juice-babyfood          6.250000   1.000  1.000  
1307359000 13G  Strawberry                         6.250000   1.000  1.000  
1307359001 13G  Strawberry-babyfood                6.250000   1.000  1.000  
1307360000 13G  Strawberry, juice                  6.250000   1.000  1.000  
1307360001 13G  Strawberry, juice-babyfood         6.250000   1.000  1.000  
1500120000 15   Corn, field, flour                 0.050000   1.000  1.000  
1500120001 15   Corn, field, flour-babyfood        0.050000   1.000  1.000  
1500121000 15   Corn, field, meal                  0.050000   1.000  1.000  
1500121001 15   Corn, field, meal-babyfood         0.050000   1.000  1.000  
1500122000 15   Corn, field, bran                  0.050000   1.000  1.000  
1500123000 15   Corn, field, starch                0.050000   1.000  1.000  
1500123001 15   Corn, field, starch-babyfood       0.050000   1.000  1.000  
1500124000 15   Corn, field, syrup                 0.050000   1.500  1.000  
1500124001 15   Corn, field, syrup-babyfood        0.050000   1.500  1.000  
1500125000 15   Corn, field, oil                   0.050000   1.000  1.000  
1500125001 15   Corn, field, oil-babyfood          0.050000   1.000  1.000  
1500127000 15   Corn, sweet                        0.050000   1.000  1.000  
1500127001 15   Corn, sweet-babyfood               0.050000   1.000  1.000  
8601000000 86A  Water, direct, all sources         0.635000   1.000  1.000  M. Bis
            Full comment: M. Biscoe, 21MAY13
8602000000 86B  Water, indirect, all sources       0.635000   1.000  1.000  M. Bis
            Full comment: M. Biscoe, 21MAY13
9500016000 O    Artichoke, globe                   0.070000   1.000  1.000  
9500073000 O    Cactus                             0.070000   1.000  1.000  
9500275000 O    Peppermint                         4.000000   1.000  1.000  
9500276000 O    Peppermint, oil                   12.000000   1.000  1.000  
9500352000 O    Spearmint                          4.000000   1.000  1.000  
9500353000 O    Spearmint, oil                    12.000000   1.000  1.000  
9500398000 O    Watercress                         3.200000   1.000  1.000  

                      Attachment 4.  Chronic Results File

U.S. EPA                                                        Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for METALDEHYDE                 NHANES 2003-2008 2-day
Residue file name: C:\Documents and Settings\wdonovan\My Documents\DEEM Version 3.16\053001c.R08
                                                 Adjustment factor #2 NOT used.
Analysis Date 05-22-2013/07:40:30     Residue file dated: 05-22-2013/07:38:09
Reference dose (RfD, Chronic) = .1 mg/kg bw/day
COMMENT 1: metaldehyde food and water (PRZM-GW) chronic
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ----------------
Total US Population                         0.016044                16.0%
Hispanic                                    0.015366                15.4%
Non-Hisp-White                              0.016438                16.4%
Non-Hisp-Black                              0.013642                13.6%
Non-Hisp-Other                              0.018251                18.3%
Nursing Infants                             0.013117                13.1%
Non-Nursing Infants                         0.046307                46.3%
Female 13+ PREG                             0.015036                15.0%
Children 1-6                                0.023447                23.4%
Children 7-12                               0.014417                14.4%
Male 13-19                                  0.011241                11.2%
Female 13-19/NP                             0.012631                12.6%
Male 20+                                    0.014471                14.5%
Female 20+/NP                               0.016556                16.6%
Seniors 55+                                 0.015465                15.5%
All Infants                                 0.036060                36.1%
Female 13-50                                0.015650                15.7%
Children 1-2                                0.026927                26.9%
Children 3-5                                0.022145                22.1%
Children 6-12                               0.015210                15.2%
Youth 13-19                                 0.011935                11.9%
Adults 20-49                                0.015495                15.5%
Adults 50-99                                0.015637                15.6%
Female 13-49                                0.015638                15.6%

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