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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 
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

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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 95th 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 noncancer 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/EPAPEST/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, 
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

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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-MAR2005; 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 
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

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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 foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup.

For 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/F

QPA 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 postimplantation 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. 
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

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Table 1. Endpoint Selection Table for Propamocarb-HCl.

1

Exposure/

Scenario

Point of 

Departure

Uncertainty/F

QPA SFs RfD, PAD, LOC Study and Toxicological Effects

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 95th 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.
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

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Table 2. Summary of Dietary (Food and Drinking Water) Exposure and Risk for Propamocarb HCl.

Population Subgroup

Acute Dietary

(95th 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. DEEMTM default 

processing factors were set to one for white potatoes-dry, tomato, puree, and tomato, paste; 

default DEEM-FCIDTM 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 95th 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
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

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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 
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

Page 8 of 12

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
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

Page 9 of 12

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 
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

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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 
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

Page 11 of 12

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
Propamocarb HCl Dietary Exposure and Risk Assessment DP# 367969

Page 12 of 12

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%

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