Document ID: EPA-HQ-OPP-2008-0887-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-06-05T04:00Z

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

                                                 	OFFICE OF CHEMICAL SAFETY AND
                                                                                            POLLUTION PREVENTION
	

MEMORANDUM

Date:		15-MAY-2013

SUBJECT:	Propamocarb Hydrochloride (Propamocarb-HCl) Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Lima Beans (Succulent).  
 
PC Code:  119302 (propamocarb-HCl)
         119301 (propamocarb)
DP Barcode:  D367969
Decision No.:  402658  
Registration No.:  264-678 
Petition No.:  8E7473
Regulatory Action:  Section 3 Registration 
Risk Assessment Type:  Dietary 
Case No.:  3124
TXR No.:  None
CAS No.:  25606-41-1 (propamocarb-HCl)
         24579-73-5 (propamocarb)
MRID No.:  None
40 CFR:  §180.499

FROM:	Jennifer R. Tyler, Chemist
	Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P)

THROUGH:	David E. Hrdy, Senior Biologist
	Ideliz Negrón-Encarnación, Ph.D., Chemist
	Dietary Exposure Science Advisory Council (DESAC)

	George F. Kramer, Ph.D., Branch Senior Scientist
	RAB1/HED (7509P)

TO:		Tamue Gibson/Barbara Madden, RM Team 05
      Registration Division (RD; 7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were 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).  This assessment used dietary survey data conducted from 2003 to 2008.  The analyses were conducted in support of a human-health risk assessment for the proposed Section 3 use of propamocarb-HCl on lima beans.  This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

Acute Dietary Exposure Assessment:  Unrefined acute dietary (food and drinking water) exposure assessments [using tolerance-level residues and assuming 100% crop treated (CT) for all registered and proposed commodities] were conducted for females 13-49 years old, and the general U.S. population and various population subgroups.  Exposure to drinking water was incorporated directly in the dietary assessment using the acute (peak) concentration for surface water generated by the PRZM-EXAMS.  This assessment indicates that the acute dietary exposure estimates are below HED's level of concern, <100% acute population-adjusted dose (aPAD), at the 95[th] exposure percentile for the general U.S. population and all other population subgroups.  The acute dietary exposure is estimated at 34% of the aPAD for females 13-49 years old, and 25% of the aPAD for the U.S. population.  The most highly exposed population subgroup is all infants (<1 year old) at 75% of the aPAD.  

Chronic Dietary Exposure Assessment:  An unrefined chronic dietary (food and drinking water) exposure assessment (using tolerance-level residues and assuming 100% CT for all registered and proposed commodities) was conducted for the general U.S. population and various population subgroups.  Exposure to drinking water was incorporated directly into the dietary assessment using the chronic (annual average) concentration for surface water generated by the PRZM-EXAMS model.  This assessment concludes that the chronic dietary exposure estimates are below HED's level of concern, <100% chronic population-adjusted dose (cPAD), for the general U.S. population and all population subgroups.  The chronic dietary exposure is estimated for the U.S. population at 31% of the cPAD, and the most highly exposed population subgroup, all infants (<1 years old), at 50% of the cPAD.  

Propamocarb is classified as "not likely to be carcinogenic to humans"; therefore, a cancer assessment is not germane to this petition.

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 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.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 propamocarb-HCl was conducted by J. Tyler (Memo, 20-FEB-2004; D297250).

II.  Residue Information

Residues of Concern:  The nature of propamocarb-HCl residues in potatoes, cucumbers, and spinach is adequately understood based on acceptable metabolism studies.  The residue of concern in these crops for tolerance and risk assessment purposes is the parent propamocarb only (Memo, J. Rowell, 03-MAY-2000; D264293).  The nature of the residue in ruminants is adequately understood based on acceptable metabolism and feeding studies on dairy cattle, which were submitted as propamocarb-HCl is currently registered for use on ruminant feed items.  The residues of concern in livestock for tolerance and risk assessment purposes are the parent propamocarb and the 2-hydroxy propamocarb and propamocarb glucuronide metabolites (Memos, J. Rowell, 03-MAY-2000, D264293; and J. Tyler, 10-MAR-2005; D304509).  No poultry metabolism study has been submitted.  Propamocarb-HCl is currently not registered for use on any poultry feed items.

Established Tolerances:  Tolerances are established for the residues of propamocarb-HCl under 40 CFR §180.499(a) in/on lettuce, leaf (90 ppm); lettuce, head (50 ppm); potato (0.06 ppm); tomato, paste (5.0 ppm); vegetable, cucurbit, group 9 (1.5 ppm); and vegetable, fruiting, group 8 (2.0 ppm).  An adequate ruminant feeding study has been submitted (Memo, J. Tyler, 10-MAR-2005; D304509).  The feeding study data with the estimated maximum dietary burdens indicate that tolerances for the combined residues of propamocarb-HCl and its metabolites 2-hydroxy propamocarb and propamocarb glucuronide should be established for milk at 0.03 ppm, and liver of cattle, horse, goat, hog, and sheep at 0.15 ppm.  These tolerances are currently not in 40 CFR §180.499, but were included in the acute and dietary exposure assessment.

Recommended Tolerances:  The available residue chemistry database supports the establishment of the permanent tolerance with a geographical restriction for residues in/on bean, lima, succulent at 2.0 ppm.

Processing Factors:  The results of previously submitted potato and tomato processing studies indicate that propamocarb-HCl does not concentrate in processed samples of potato chips, flakes, wet peel, or dry peel (Memo, J. Stokes 10/17/96; Barcode D228264), but does concentrate in tomato puree (1.3x) and tomato paste (3.1x).  As the established tolerance of 2.0 ppm for fruiting vegetables will adequately cover residues in tomato puree, a tolerance was not required for this processed commodity; however, a tolerance of 5.0 ppm for residues in tomato, paste was established.  As a result of the potato and tomato processing studies, DEEM-FCID default processing factors were set to 1 for white potatoes-dry; tomato, paste; and tomato, puree.  DEEM-FCID default processing factors were used for all other registered and proposed commodities.

III.  Percent Crop Treated Information

The acute and chronic dietary exposure assessments assumed 100% CT for all registered and proposed uses.

IV.  Drinking Water Data

The estimated drinking water concentrations (EDWCs) used in the acute and chronic dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the memorandum dated 11-DEC-2012 (Memo, M. Ruhman; D368070).  Water residues were incorporated in the DEEM-FCID into the food categories "water, direct, all sources" and "water, indirect, all sources."  The surface water values (using PRZM/EXAMS) for the acute (peak) and chronic (annual average) EDWCs, based on the container-grown ornamental use pattern, are 8,762 ppb and 1,067 ppb, respectively.

V.  DEEM-FCID Program and Consumption Information

Propamocarb-HCl acute and chronic dietary exposure assessments were conducted using the DEEM-FCID, Version 3.16, which incorporates consumption data from USDA's NHANES/WWEIA.  This dietary survey was conducted from 2003 to 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+ 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

A summary of the toxicological doses and endpoints selected for dietary exposure assessment is provided in Table 1. 

Table 1.  Endpoint Selection Table for Propamocarb-HCl.[1]
                                   Exposure/
                                   Scenario
                              Point of Departure
                             Uncertainty/FQPA SFs
                                 RfD, PAD, LOC
                        Study and Toxicological Effects
Acute Dietary (Females 13-50 years of age)
NOAEL = 150 mg /kg/day

UFA = 10X
UFH =10X
FQPA SF = 1X
aRfD = aPAD = 1.5 mg/kg/day
Developmental Toxicity Study - Rabbit
Developmental LOAEL = 300 mg/kg/day based on increased post-implantation loss. 
Acute Dietary (General Population, including Infants and Children)
NOAEL = 200 mg/kg/day

UFA = 10X
UFH =10X
FQPA SF = 1X
aRfD = aPAD = 2.0 mg/kg/day
Acute Neurotoxicity Screening Battery - Rat
LOAEL = 2000 mg/kg/day, based on decreased body-weight gain and decreased motor activity. 
Chronic Dietary (All Populations)
NOAEL = 12 mg/kg/day

UFA = 10X
UFH =10X
FQPA SF = 1X
cRfD = cPAD = 0.12 mg/kg/day 
Carcinogenicity Study - Mouse
LOAEL = 95 mg/kg/day, based on decreased body weight and body-weight gain in females. 
Cancer (oral, dermal, inhalation)   
Classification:  "Not likely to be Carcinogenic to Humans."
[1]  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, NOAEL = no-observed adverse-effect level, LOAEL = lowest-observed adverse-effect level, RfD = reference dose (a = acute, c = chronic), PAD = population-adjusted dose (a = acute, c = chronic). 

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 2 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:  Separate unrefined (using tolerance-level residues and assuming 100% CT for all registered and proposed commodities), acute dietary exposure assessments were conducted for females 13-49 years old, and the general U.S. population and various population subgroups.  Drinking water was incorporated directly in the dietary assessments using the acute (peak) concentration for surface water generated by the PRZM/EXAMS model.  This assessment concludes that the acute dietary exposure estimates are below HED's level of concern (<100% aPAD) at the 95[th] exposure percentile for females 13-49 years old (34% of the aPAD), the general U.S. population (25% of the aPAD), and all other population subgroups.  The most highly exposed population subgroup is all infants (<1 year old), at 75% of the aPAD.

 Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis:  An unrefined (using tolerance-level residues and assuming 100% CT for all registered and proposed commodities), chronic dietary exposure assessment was conducted for the general U.S. population and various population subgroups.  Drinking water was incorporated directly into the dietary assessment using the chronic (annual average) concentration for surface water generated by the PRZM/EXAMS model.  This assessment concludes that the chronic dietary exposure estimates are below HED's level of concern (<100% cPAD) for the general U.S. population (31% of the cPAD) and all population subgroups.  The most highly exposed population subgroup is all infants (<1 year old), at 50% of the aPAD.

 Table 2.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for Propamocarb HCl.
                              Population Subgroup
                                 Acute Dietary
                              (95[th] Percentile)
                                Chronic Dietary
                                        
                          Dietary Exposure (mg/kg/day)
                                    % aPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                    % cPAD*
                            General U.S. Population
                                    0.507723
                                       25
                                    0.037228
                                       31
                          All Infants (<1 year old)
                                    1.496493
                                      75*
                                    0.060367
                                      50*
                             Children 1-2 years old
                                    0.762741
                                       38
                                    0.045611
                                       38
                             Children 3-5 years old
                                    0.633181
                                       32
                                    0.044067
                                       37
                            Children 6-12 years old
                                    0.473593
                                       24
                                    0.032129
                                       27
                             Youth 13-19 years old
                                    0.416725
                                       21
                                    0.028399
                                       24
                             Adults 20-49 years old
                                    0.501031
                                       25
                                    0.038290
                                       32
                              Adults 50+ years old
                                    0.449098
                                       22
                                    0.037513
                                       31
                            Females 13-49 years old
                                    0.510324
                                       34
                                    0.039067
                                       33
*The subpopulation(s) with the highest risk estimates.

 VIII.  Characterization of Inputs/Outputs
 
The acute and chronic dietary assessments were highly conservative, using tolerance-level residues, and 100% CT information for all registered and proposed uses.  DEEM(TM) default processing factors were set to one for white potatoes-dry, tomato, puree, and tomato, paste; default DEEM-FCID(TM) processing factors were used for all other registered and proposed processed commodities.  Various refinements could be made to the assessments.  However, as there are no risk estimates of concern, no refinements were incorporated.

 IX.  Conclusions
 
 Unrefined, acute dietary exposure assessment indicates that the acute dietary exposure estimates are below HED's level of concern, <100% aPAD, at the 95[th] exposure percentile for the general U.S. population and all other population subgroups.  The most highly exposed population subgroup was all infants (<1 year old) at 74% of the aPAD.  An unrefined chronic dietary exposure assessment indicates that the chronic dietary exposure estimates are below HED's level of concern (<100% cPAD) for the general U.S. population and all population subgroups.  The most highly exposed population subgroup was all infants (<1 year old) at 50% of the cPAD.  The acute and chronic assessments were highly conservative, using several upper-end assumptions.  Additional refinements, such as inclusion of ARs and %CT data could be made in order to refine the future assessments.  HED is confident that the assessments do not underestimate risk to the general U.S. population or any population subgroup.
 
 X.  List of Attachments
 
 Attachment 1:  Acute Food plus Water Residue Input File.
 Attachment 2:  Acute Results File.
 Attachment 3:  Chronic Food plus Water Residue Input File.
 Attachment 4:  Chronic Results File.

cc: J. Tyler
RDI:  D. Hrdy (1/4/13); I. Encarnacion (1/4/13); G. Kramer (5/15/13)
J. Tyler: S-10943: Potomac Yard 1 (PY1): (703) 305-5564: 7509P: RAB1

            Attachment 1:  Acute Food plus Water Residue Input File.

Filename: C:\Documents and Settings\jtyler\My Documents\JenWork\$Propamocarb\Lima Beans\Dietary\119302acute.r08
Chemical: Propamocarb HCl
RfD(Chronic): .12 mg/kg bw/day  NOEL(Chronic): 12 mg/kg bw/day
RfD(Acute): 2 mg/kg bw/day  NOEL(Acute):  200 mg/kg bw/day
Date created/last modified: 01-02-2013/14:21:05       Program ver. 3.16, 03-08-d
Comment: New use on lima beans
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2   
---------- ---- -------------------------------  ----------  ------ ------  -------
0103296000 1C   Potato, chips                      0.060000   1.000  1.000  
0103297000 1C   Potato, dry (granules/ flakes)     0.060000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0103297001 1C   Potato, dry (granules/ flakes)-b   0.060000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0103298000 1C   Potato, flour                      0.060000   1.000  1.000  
0103298001 1C   Potato, flour-babyfood             0.060000   1.000  1.000  
0103300000 1C   Potato, tuber, w/o peel            0.060000   1.000  1.000  
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.060000   1.000  1.000  
0103299000 1C   Potato, tuber, w/peel              0.060000   1.000  1.000  
0103299001 1C   Potato, tuber, w/peel-babyfood     0.060000   1.000  1.000  
0401204000 4A   Lettuce, head                     50.000000   1.000  1.000  
0401205000 4A   Lettuce, leaf                     90.000000   1.000  1.000  
0602037000 6B   Bean, lima, succulent              2.000000   1.000  1.000  Propos
            Full comment: Proposed
0802148000 8BC  Eggplant                           2.000000   1.000  1.000  
0802234000 8BC  Okra                               2.000000   1.000  1.000  
0802270000 8B   Pepper, bell                       2.000000   1.000  1.000  
0802271000 8B   Pepper, bell, dried                2.000000   1.000  1.000  
0802271001 8B   Pepper, bell, dried-babyfood       2.000000   1.000  1.000  
0802270001 8B   Pepper, bell-babyfood              2.000000   1.000  1.000  
0802272000 8BC  Pepper, nonbell                    2.000000   1.000  1.000  
0802273000 8BC  Pepper, nonbell, dried             2.000000   1.000  1.000  
0802272001 8BC  Pepper, nonbell-babyfood           2.000000   1.000  1.000  
0801374000 8A   Tomatillo                          2.000000   1.000  1.000  
0801375000 8A   Tomato                             2.000000   1.000  1.000  
0801380000 8A   Tomato, Tree                       2.000000   1.000  1.000  
0801378000 8A   Tomato, dried                      2.000000  14.300  1.000  defaul
            Full comment: default processing factor
0801378001 8A   Tomato, dried-babyfood             2.000000  14.300  1.000  defaul
            Full comment: default processing factor
0801379000 8A   Tomato, juice                      2.000000   1.500  1.000  defaul
            Full comment: default processing factor
0801376000 8A   Tomato, paste                      5.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0801376001 8A   Tomato, paste-babyfood             5.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0801377000 8A   Tomato, puree                      2.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0801377001 8A   Tomato, puree-babyfood             2.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1.
0801375001 8A   Tomato-babyfood                    2.000000   1.000  1.000  
0902021000 9B   Balsam pear                        1.500000   1.000  1.000  
0901075000 9A   Cantaloupe                         1.500000   1.000  1.000  
0902088000 9B   Chayote, fruit                     1.500000   1.000  1.000  
0902102000 9B   Chinese waxgourd                   1.500000   1.000  1.000  
0902135000 9B   Cucumber                           1.500000   1.000  1.000  
0901187000 9A   Honeydew melon                     1.500000   1.000  1.000  
0902308000 9B   Pumpkin                            1.500000   1.000  1.000  
0902309000 9B   Pumpkin, seed                      1.500000   1.000  1.000  
0902356000 9B   Squash, summer                     1.500000   1.000  1.000  
0902356001 9B   Squash, summer-babyfood            1.500000   1.000  1.000  
0902357000 9B   Squash, winter                     1.500000   1.000  1.000  
0902357001 9B   Squash, winter-babyfood            1.500000   1.000  1.000  
0901399000 9A   Watermelon                         1.500000   1.000  1.000  
0901400000 9A   Watermelon, juice                  1.500000   1.000  1.000  
3100049000 31   Beef, liver                        0.150000   1.000  1.000  
3100049001 31   Beef, liver-babyfood               0.150000   1.000  1.000  
3200173000 32   Goat, liver                        0.150000   1.000  1.000  
3400295000 34   Pork, liver                        0.150000   1.000  1.000  
3500343000 35   Sheep, liver                       0.150000   1.000  1.000  
3600222000 36   Milk, fat                          0.030000   1.000  1.000  
3600222001 36   Milk, fat-baby food/infant formu   0.030000   1.000  1.000  
3600223000 36   Milk, nonfat solids                0.030000   1.000  1.000  
3600223001 36   Milk, nonfat solids-baby food/in   0.030000   1.000  1.000  
3600225001 36   Milk, sugar (lactose)-baby food/   0.030000   1.000  1.000  
3600224000 36   Milk, water                        0.030000   1.000  1.000  
3600224001 36   Milk, water-babyfood/infant form   0.030000   1.000  1.000  
8601000000 86A  Water, direct, all sources         8.762000   1.000  1.000  acute 
            Full comment: acute surface water = 8762 ppb
8602000000 86B  Water, indirect, all sources       8.762000   1.000  1.000  acute 
            Full comment: acute surface water = 8762 ppb

                       Attachment 2:  Acute Results File.

EPA                                                         Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for PROPAMOCARB HCL             NHANES 2003-2008 2-Day
Residue file: 119302acute.r08                     Adjustment factor #2 NOT used.
Analysis Date: 01-02-2013/14:30:21    Residue file dated: 01-02-2013/14:21:05
NOEL (Acute) = 150.000000 mg/kg body-wt/day
RAC/FF intake summed over 24 hours
Run Comment: "New use on lima beans"
===============================================================================

Summary calculations--per capita:

---   95th Percentile----   ---   99th Percentile----     ---99.9th Percentile----
 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE  
---------- ------- -------- ---------- ------- -------- ---------- ------- --------
Female 13-49:
  0.510324   34.02     293    0.743490   49.57     201    1.011665   67.44     148  

EPA                                                         Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for PROPAMOCARB HCL             NHANES 2003-2008 2-Day
Residue file: 119302acute.r08                     Adjustment factor #2 NOT used.
Analysis Date: 01-02-2013/14:29:47    Residue file dated: 01-02-2013/14:21:05
NOEL (Acute) = 200.000000 mg/kg body-wt/day
RAC/FF intake summed over 24 hours
Run Comment: "New use on lima beans"
===============================================================================

Summary calculations--per capita:

---   95th Percentile----   ---   99th Percentile----     ---99.9th Percentile----
 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE  
---------- ------- -------- ---------- ------- -------- ---------- ------- --------
Total US Population:
  0.507723   25.39     393    0.814838   40.74     245    1.497184   74.86     133  
All Infants:
  1.496493   74.82     133    2.032841  101.64      98    2.979369  148.97      67  
Children 1-2:
  0.762741   38.14     262    1.124264   56.21     177    2.725537  136.28      73  
Children 3-5:
  0.633181   31.66     315    0.969279   48.46     206    1.512119   75.61     132  
Children 6-12:
  0.473593   23.68     422    0.768693   38.43     260    1.153887   57.69     173  
Youth 13-19:
  0.416725   20.84     479    0.679147   33.96     294    1.043993   52.20     191  
Adults 20-49:
  0.501031   25.05     399    0.730983   36.55     273    1.025770   51.29     194  
Adults 50-99:
  0.449098   22.45     445    0.663922   33.20     301    1.001162   50.06     199  

           Attachment 3:  Chronic Food plus Water Residue Input File.

Filename: C:\Documents and Settings\jtyler\My Documents\JenWork\$Propamocarb\Lima Beans\Dietary\119302chronic.r08
Chemical: Propamocarb HCl
RfD(Chronic): .12 mg/kg bw/day  NOEL(Chronic): 12 mg/kg bw/day
RfD(Acute): 2 mg/kg bw/day  NOEL(Acute):  200 mg/kg bw/day
Date created/last modified: 01-02-2013/14:25:13       Program ver. 3.16, 03-08-d
Comment: New use on lima beans
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2   
---------- ---- -------------------------------  ----------  ------ ------  -------
0103296000 1C   Potato, chips                      0.060000   1.000  1.000  
0103297000 1C   Potato, dry (granules/ flakes)     0.060000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0103297001 1C   Potato, dry (granules/ flakes)-b   0.060000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0103298000 1C   Potato, flour                      0.060000   1.000  1.000  
0103298001 1C   Potato, flour-babyfood             0.060000   1.000  1.000  
0103300000 1C   Potato, tuber, w/o peel            0.060000   1.000  1.000  
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.060000   1.000  1.000  
0103299000 1C   Potato, tuber, w/peel              0.060000   1.000  1.000  
0103299001 1C   Potato, tuber, w/peel-babyfood     0.060000   1.000  1.000  
0401204000 4A   Lettuce, head                     50.000000   1.000  1.000  
0401205000 4A   Lettuce, leaf                     90.000000   1.000  1.000  
0602037000 6B   Bean, lima, succulent              2.000000   1.000  1.000  Propos
            Full comment: Proposed
0802148000 8BC  Eggplant                           2.000000   1.000  1.000  
0802234000 8BC  Okra                               2.000000   1.000  1.000  
0802270000 8B   Pepper, bell                       2.000000   1.000  1.000  
0802271000 8B   Pepper, bell, dried                2.000000   1.000  1.000  
0802271001 8B   Pepper, bell, dried-babyfood       2.000000   1.000  1.000  
0802270001 8B   Pepper, bell-babyfood              2.000000   1.000  1.000  
0802272000 8BC  Pepper, nonbell                    2.000000   1.000  1.000  
0802273000 8BC  Pepper, nonbell, dried             2.000000   1.000  1.000  
0802272001 8BC  Pepper, nonbell-babyfood           2.000000   1.000  1.000  
0801374000 8A   Tomatillo                          2.000000   1.000  1.000  
0801375000 8A   Tomato                             2.000000   1.000  1.000  
0801380000 8A   Tomato, Tree                       2.000000   1.000  1.000  
0801378000 8A   Tomato, dried                      2.000000  14.300  1.000  defaul
            Full comment: default processing factor
0801378001 8A   Tomato, dried-babyfood             2.000000  14.300  1.000  defaul
            Full comment: default processing factor
0801379000 8A   Tomato, juice                      2.000000   1.500  1.000  defaul
            Full comment: default processing factor
0801376000 8A   Tomato, paste                      5.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0801376001 8A   Tomato, paste-babyfood             5.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0801377000 8A   Tomato, puree                      2.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0801377001 8A   Tomato, puree-babyfood             2.000000   1.000  1.000  proces
            Full comment: processing factor adjusted to 1
0801375001 8A   Tomato-babyfood                    2.000000   1.000  1.000  
0902021000 9B   Balsam pear                        1.500000   1.000  1.000  
0901075000 9A   Cantaloupe                         1.500000   1.000  1.000  
0902088000 9B   Chayote, fruit                     1.500000   1.000  1.000  
0902102000 9B   Chinese waxgourd                   1.500000   1.000  1.000  
0902135000 9B   Cucumber                           1.500000   1.000  1.000  
0901187000 9A   Honeydew melon                     1.500000   1.000  1.000  
0902308000 9B   Pumpkin                            1.500000   1.000  1.000  
0902309000 9B   Pumpkin, seed                      1.500000   1.000  1.000  
0902356000 9B   Squash, summer                     1.500000   1.000  1.000  
0902356001 9B   Squash, summer-babyfood            1.500000   1.000  1.000  
0902357000 9B   Squash, winter                     1.500000   1.000  1.000  
0902357001 9B   Squash, winter-babyfood            1.500000   1.000  1.000  
0901399000 9A   Watermelon                         1.500000   1.000  1.000  
0901400000 9A   Watermelon, juice                  1.500000   1.000  1.000  
3100049000 31   Beef, liver                        0.150000   1.000  1.000  
3100049001 31   Beef, liver-babyfood               0.150000   1.000  1.000  
3200173000 32   Goat, liver                        0.150000   1.000  1.000  
3400295000 34   Pork, liver                        0.150000   1.000  1.000  
3500343000 35   Sheep, liver                       0.150000   1.000  1.000  
3600222000 36   Milk, fat                          0.030000   1.000  1.000  
3600222001 36   Milk, fat-baby food/infant formu   0.030000   1.000  1.000  
3600223000 36   Milk, nonfat solids                0.030000   1.000  1.000  
3600223001 36   Milk, nonfat solids-baby food/in   0.030000   1.000  1.000  
3600225001 36   Milk, sugar (lactose)-baby food/   0.030000   1.000  1.000  
3600224000 36   Milk, water                        0.030000   1.000  1.000  
3600224001 36   Milk, water-babyfood/infant form   0.030000   1.000  1.000  
8601000000 86A  Water, direct, all sources         1.067000   1.000  1.000  chroni
            Full comment: chronic surface water = 1067ppb
8602000000 86B  Water, indirect, all sources       1.067000   1.000  1.000  chroni
            Full comment: chronic surface water = 1067ppb

                      Attachment 4:  Chronic Results File.

EPA                                                             Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for PROPAMOCARB HCL             NHANES 2003-2008 2-day
Residue file name: C:\Documents and Settings\jtyler\My Documents\JenWork\$Propamocarb\Lima Beans\Dietary\119302chronic.r08
                                                 Adjustment factor #2 NOT used.
Analysis Date 01-02-2013/14:27:09     Residue file dated: 01-02-2013/14:25:13
Reference dose (RfD, Chronic) = .12 mg/kg bw/day
COMMENT 1: New use on lima beans
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ----------------
Total US Population                         0.037228                31.0%
Hispanic                                    0.034975                29.1%
Non-Hisp-White                              0.039137                32.6%
Non-Hisp-Black                              0.028491                23.7%
Non-Hisp-Other                              0.038325                31.9%
Nursing Infants                             0.022271                18.6%
Non-Nursing Infants                         0.077381                64.5%
Female 13+ PREG                             0.036526                30.4%
Children 1-6                                0.044067                36.7%
Children 7-12                               0.030645                25.5%
Male 13-19                                  0.026481                22.1%
Female 13-19/NP                             0.030271                25.2%
Male 20+                                    0.034790                29.0%
Female 20+/NP                               0.040903                34.1%
Seniors 55+                                 0.036752                30.6%
All Infants                                 0.060367                50.3%
Female 13-50                                0.039077                32.6%
Children 1-2                                0.045611                38.0%
Children 3-5                                0.044067                36.7%
Children 6-12                               0.032129                26.8%
Youth 13-19                                 0.028399                23.7%
Adults 20-49                                0.038290                31.9%
Adults 50-99                                0.037513                31.3%
Female 13-49                                0.039067                32.6%

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