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### UNITED STA

**TES ENVIRONMENTA L PROTECTION A**  **GENCY WA** **SHINGTON, 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 L ima Beans (Succulent) . **PC Code :**  119302 (propamocarb - HCl)

119301 (propamocarb) **DP Barcode:** D 367969 **Decision No.:** 402658 **Registration No. :**  264 - 678 **Petition No.:** 8E7473 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** Dietary **Case No.:** 3124 **T XR 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. Hrd y, Senior Biologis t

Id eliz 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

I ntake Database (DEEM - FCID) Version 3.16 , which uses food consumption data from the U.S. D epartment 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 anal ys es were conducted in support of a human - health ri sk assessment for the proposed Section 3 use of propamocarb - HCl on lima beans . This memorandum was reviewed b y two peer reviewers of the DESAC, per DESAC SOPPropamocarb 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) ex posure assessment s [ using tolerance - level residues and assuming 100% crop treated (CT) for all registe red and proposed commodities] were conducted for females 13 - 49 y ears old, and the general U.S. population and various population subgroups. Exposure to d rinking water was incorporated directl y in the dietary assessment using the acute (peak) concentration for surface water generated b y the PRZM - EXAMS . This assessment indicates that the acute dietary exposure estimates are below HED’s level of concern, <10 0% 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 y ears old, and 25% of the aPAD for the U.S. population . The most highl y exposed population subgrou p is all infants (<1 y ear old) at 75 % of the aPAD. Chronic Dietary Exposure Assessment : A n unrefined chronic dietary (food and drinking water) exposure assessment ( using tolerance - level re sidues 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. po pulation 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 subgrou p, all infants (<1 ye ars 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, LO AE L, e.g.) divided by the required uncertaint y or safet y 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/J uly

/Day - 12/6061.pdf

; or see SOP 99.6 (20 - AUG - 1999). The most recent dietary risk assessment for propamocarb - HCl wa s conducted by J. Ty ler (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 onl y (Memo, J. Rowell, 03 - MAY - 2000; D264293). The nature of the residue in ruminants is adequatel y 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 - hy droxy propamocarb and propamocarb glucuronide metabolites (Memos, J. Rowell, 03 - MAY - 2000, D264293; and J. Tyler, 10 - MAR - 2005; D304509) . No poultry metabolism stud y has been submitted. Propamocarb - HCl is currently not registered for use on an y poultry

feed items. Established Tolerances: Tolerances are establish ed for the residues of propamocarb - HCl under 40 CFR §180.4 99(a) in/on lettuce, leaf ( 90 ppm); lettuce, h ead ( 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 stud y has been submitted (Memo, J. Tyler, 10 - MAR 2005; D304509). The feeding stud y data with the estimated maximum dietary burdens indicate that tolerances for the combined residues of propamocarb - HCl and its metabolites 2 - hy drox y 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 restricti on for residues in/on bean, lima , succulent at 2.0 ppm. Processing Factors: The results o f previousl y submitted potato and tomato processing studies indicate that propamocarb - HCl d oes 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 p uree (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 o ther registered and proposed commodities. **I I**  **I. 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 - F CI D 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 ave rage) EDWCs, based on the container - grown ornamental use pattern, are 8,7 62 ppb and 1,067 ppb, respectivel y. **V. DEEM**  **- FCID Program and Consumption Information**  Propamocarb - HCl acute and chronic dietary exposure assessments were conducted using thePropamocarb 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 day s. 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 anal ys is 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 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ y ears 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 averag e dail y 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 lis t to arrive at the total average estimated exposure. Exposure is expressed in mg/kg bod y 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 consump tion 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., onl y those who reported eating relevant commoditie s/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 analy ses performed at all levels of refinement . How ever, for deterministic assessments , any significant differences in user vs. per capita exposure and risk are specificall y 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 Propam**  **ocarb -**  **HCl .**  **1 Exposure/**  **Scenario Point of** 

**Departure Uncertainty/F** 

**QPA SFs RfD, PAD, LOC**  **Study and Toxicological Effects**  Ac ute Dietary (Fem ales 13 - 50 years of age) NOAEL = 150

mg /kg/day UF A = 10X

UF H = 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 im plantation loss. Ac ute Dietary (General Population, including Infants and Children) NOAEL = 200

mg/kg/day UF A = 10X

UF H =10X FQPA SF = 1X **aRfD** = **aPAD** =

2.0 mg/kg/day Ac ute Neurotoxicity Scree ning 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

Page 5 of 12 **Table 1. Endpoint Selection Table for Propam**  **ocarb -**  **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 UF A = 10X

UF H =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, UF A = extrapolation from animal to human (interspecies), UF H = 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 - eff

ect 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 anal ys es 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 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, females 13 - 49, adults 20 - 49, and adults 50 - 99 y ears. 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 assessment s were conducted for females 13 - 49 y ears old, and the general U.S. population and various population subgroups. Drinking water was incorporated directl y in the dietary assessment s using the acute (peak) concentration for surf ac e water generated b y 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 y ears old (34% of the aPAD), the general U.S. po pulation (25 % of the aPAD) , and all other population subgroups. The most highly exposed population subgroup is all infants (<1 ye ar 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 highl y exposed population subgroup is all infants (<1 ye ar old), at 50% of the aPAD.Propamocarb HCl Dietary Exposure and Risk Assessment DP # 367969

Page 6 of 12 **Table 2 . Summary of Dietary**  **(Food and Drinking Water )**  **Exposure and Risk for Propam**  **ocarb HCl. Population Subgroup**  **Acute Dietary (95**  **th Percentile)**  **Chronic Dietary Dietary Exposure**  **(m g/kg/day)**  **% aPAD*** **Dietary Exposure (m**  **g/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 y ears old 0.762741 38 0.045611 38 Children 3 - 5 y ears old 0.633181 32 0.044067 37 Children 6 - 12 y ears old 0.473593 24 0.032129 27 Youth 13 - 19 y ears old 0.416725 21 0.028399 24 Ad ults 20 - 49 y ears old 0.501031 25 0.038290 32 Ad ults 50+ years old 0.449098 22 0.037513 31 Fem ales 13 - 49 y ears 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 highl y 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 t omato, 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 incor porated. **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 chr onic dietary exposure estimates are below HED’s level of concern (<100% cPAD) for the general U.S. population and all population subgroups. T he most highly

exposed population subgroup was all infants (<1 ye ar old) at 50 % of the cPAD. The acute and chroni c assessments were highl y 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 assessment s do not underestimate risk to the general U.S. population or an y 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: RAB1Propamocarb 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 c reated/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 01 03297000 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: process ing 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 08021480 00 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, dri ed 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 ad justed 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 p ear 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, s ummer - 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 1.000Propamocarb 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, f at 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 1.00 0 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: acu te surface water = 8762 ppbPropamocarb HCl Dietary Exposure and Risk Assessment DP # 367969

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### 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 Percent ile ---- --- 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 2.7 25537 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 199Propamocarb 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 li ma 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 1.00 0 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 080223400 0 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, drie d - 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 0801380 000 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 1.000Propamocarb HCl Dietary Exposure and Risk Assessment DP # 367969

Page 11 of 12 09013990 00 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 - babyf ood 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 0.15000 0 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, wat er - 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 = 1067ppbPropamocarb 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 - 2013/1 4:27:09 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 popu lation 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%

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