UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: 09/16/2015 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Pronamide. Acute and Chronic Aggregate Dietary (Food and Drinking Water) 

Exposure and Risk Assessment in Support of Registration. Review and the Section 

(3) Registration Action for Leaf Lettuce. 

PC Code: 10170 1 

Decision No.: 494q J.!.,., 

Petition No.: 4F830 I 

Risk Assessment Type: Dietary 

TXRNo.: NA 

MRIDNo.: NA 

DP Barcode: D427082 

Registration No.: 62719-394 

Regulatory Action: Section 3 Registration 

Case No.: 0082 

CAS No.: 23950-58-5 

40 CFR: § 180.317 

FROM: Ideliz Negr6n-Encarnaci6n, Ph.D., Chemist ;t{/tt.7'1 ..___-

Risk Assessment Branch V 

THROUGH: 

TO: 

Health Effects Division (I-TED; 7509P) 

Pete 

William 

Savoia

Cut

, 

c

C

hin

hemi

, C

st 

hemi

0-:

st 1: ·'-~

r <,. t:__ 

,z,

...... 

,.._l 

/a-

~. 1, 

v 

.... -

~ 

Dietary Exposure Science Advisory Council (DESAC) 

Mindy Ondish, Risk Manager 

Registration Division (7505P) 

Executive Summa ry 

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. This software uses 2003-2008 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). For registration 

actions: The analysis was conducted in support of a human-health risk assessment for the 

proposed Section 3 uses of pronamide on leaf lettuce. This memorandum was reviewed by two 

peer reviewers of the DESAC, per DESAC SOP 20 12. 1. 

Page I of 16 
Pron amide Dietary Exposure and Risk Assessment DP Number: D427082 

Unrefined acute and chronic dietary assessments were perfonned. Tolerance level residues of 

pronamide (residues convertible to methyl 3,5-dichlorobenzoate) were used for the registered 

uses and proposed new use on leaf lettuce. Default processing factors and 100% of crop treated 

(CT) assumptions were incorporated. Drinking water was incorporated directly in the dietary 

assessment using the Tier II acute and chronic estimated drinking water concentration (EDWC) 

for surface water generated by the Surface Water Concentration Calculator (SWCC). 

Acute Dieta1y Exposure Assessment 

The resulting acute dietary exposure estimates using the DEEM-FCIOTM model were less than 

100% of the acute population adjusted dose (aPAD) at the 95ih percentile of exposure for the 

general U.S. population and all population subgroups. Pronamide acute di etary exposure (food + 

drinking water) was estimated at 0.007144 mg/kg/day for the general U.S. population (18% of 

the aPAD) and 0.018539 mg/kg/day (46% of the aPAD) for the most highly exposed population 

subgroup (All Infants < 1 year old). The results per user and per capita are similar. 

Chronic Dieta1y Exposure Assessment 

The resulting chronic dietary exposure estimates using the DEEM-FCIDTM model were less than 

100% of the chronic population adjusted dose (cPAD) for the general U.S. population and all 

population subgroups. Pronamide chronic dietary exposure (food+ drinking water) was 

estimated at 0.001706 mg/kg/day for the general U.S. population ( 4.3% of the cPAD) and 

0.004410 mg/kg/day ( 11 % of the cPAD) for the most highly exposed population subgroup 

(Children 1-2 years old). 

Pronamide was classified as "Not Likely to be Carcinogenic to Humans" at doses that do not 

result in induction of hepatic cell proliferation or metabolic enzymes leading to disruption of 

thyroid or gonadal endocrine axes; therefore, a cancer risk assessment is not needed. 

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 population-adjusted dose (PAD). The PAD is equivalent to the 

point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety 

factors. 

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds I 00% of the PAD. References that discuss the acute and chronic risk assessments in 

more detail are available on the EPNpesticides web site: '·Available Information on Assessing 

Exposure from Pesticides, A User's Guide," 2 l-JUN-2000, web link: 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-l 2/606 l .pdf; or see SOP 99.6 (20-AUG1999). 

Page 2 of 16 
Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

The most recent dietary risk assessment for pronamide was conducted by Sarah J. Levy 

(0712012007, D340385). Recently, it was determined that pronamide is not likely to be a 

carcinogen in humans (CARC report 101701.004 CA.DOC; J. Rowland, 12/02/2014). 

Moreover, the ToxSAC has reevaluated the toxicological database for pronamide resulting in 

new endpoints and points of departure being selected for dietary assessment purposes (S. 

Dapson, Thjdiazuron Human Health Risk Assessment, In Process). This reevaluation included 

the selection of an acute endpoint for dietary assessment purposes. 

II. Residue Information 

Tolerances for pronamide are currently established under 40 CFR § l 80.3 l 7(a), (b), and (c). The 

tolerance expression, listed for these sections, is in terms of the combined residues of the 

herbicide pronamides and its metabolites (containing the 3,5-dichlorobenzoyl moiety and 

calculated as 3,5-dichloro-N-(1, l-dimethyl-2-propynyl)benzamide). Pronamide and its 

metabolites containing the 3,5-dichlorobenzoyl moiety are considered the residues of concern for 

risk assessment in plant, livestock, and rotational crop commodities as well. Therefore, the 

current and proposed tolerances account for all the residues of concern for risk assessment. 

Table 1. Summary of Pronamide Metabolites a nd Oegradates to be included in the Risk Assessment and 

Tolerance Expression 

Matrix Residues included in Risk Residues included in 

Assessment Tolerance Expression 

Plants Primary Crop 

Rotational Crop pronamide and its metabolites pronamide and its metabolites 

Livestock Ruminant containing the 3,5- containing the 3,5-

Poultry dichlorobenzoyl moiety dichlorobcnzoyl moiety 

Drinking Water Not Applicable 

Pending label modifications, HED recommended in favor of the new use of pronamide on leaf 

lettuce (1. Negron-Encarnacion, D424598, 0l/15/2015). The submitted data support the 

permanent tolerance of 2 ppm for the residues of propyzamide and its metabolites (containing the 

3,5-dichlorobenzoyl moiety and calculated as 3,5-dichloro-N-( I, l-dimethyl-2-

propynyl)benzamide) in/on leaf lettuce. 

For all registered and proposed new uses, the acute and chronic dietary assessments assumed 

DEEM-FCIDTM default processing factors, and tolerance-level residues. The tolerance for 

radiacchio was translated to Belgium endive. The established tolerances for livestock 

commodities are adequate to support registration review; therefore, the existing tolerance levels 

for livestock were incorporated in the dietary assessment. The USDA Pesticide Data Program 

(PDP) monitored pesticide residues in catfish in 2008, 2009, and 20 I 0. Over this 3-year period, 

PDP analyzed 1479 samples of catfish for residues of pronamide. None of the samples contruned 

detectable residues. As a result, residues in fish were not included in the assessment. 

III. Percent Crop Treated Information 

The acute and chronic assessments were performed by assuming that l 00% of the crop was 

treated for all food commodities. 

Page 3of 16 
Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

IV. Drinking Water Data 

The drinking water residues used in the dietary risk assessment were provided by the 

Environmental Fate and Effects Division (EFED) in the following memorandum: '·Propyzamide 

(Pronamide): Tier II Drinking Water Exposure Assessment in support of the Proposed Use of 

Propyzamide on Leaf Lettuce" (0 414467, K. Milians, 04/2 1/2015) and incorporated directly into 

this dietary assessment. Water residues were incorporated in the DEEM-FCID into the food 

categories "water, direct, all sources" and "water, indirect, all sources.'' 

Besides modeling the use of leaf lettuce, EFED modeled the use of artichoke because this use 

allows the maximum application rate (for any crop) of 8 lbs a.i./acre (i.e., 4 lbs a.i./acre x 2 

assumed applications/yr). Table 2 shows the estimated drinking water concentrations in surface 

water and ground water (including values using Sci-Grow and PRZM-GW for ground water). 

The estimated drinking water concentrations recommended by EFED are 102 ppb for the acute 

dietary assessment and 47.0 ppb for the chronic and cancer dietary assessments. 

Ta ble 2. Tier U T ota l Residue of Concern EDWCs in Surface Water a nd G round Water from Propyzamide 

Uses on New Uses (Maximum EDWCs in Bold). 

Drinking Water Source (Model, EDWCs 

Use, Modeled rate) Scenario 

Acute (μg/L) Chronic (μg/L) Cancer (μg/L) 

Surface Water (SWCC, Artichokes. CA row crop 4 lb a.i./A x 2 applic.: total of8 RLF (aerial 61.4 33.4 26.0 

lb/A/yr) application) 

Surface Water (SWCC, Leaf CA lenuce 

Lettuce, 2 lb a. i./A x 2 applic.: total (aerial 102 47.0 33.6 

of 4 lb/A/yr) application) 

Ground Water (PRZM-GW, 

Artichokes, WI sands 2 1 18.6 18.6 4 lb a.i./A x 2 applic.; total of4 

lb/A/yr) 

Ground Water (SCI-GROW, 

Artichokes, N/A 0.802 0.802 0.802 4 lb a.i./A x 2 applic.; total of8 

lb/A/yr) 

Ground Water (SCI-GROW, Leaf 

Lenuce, 2 lb a. i./A x 2 applic.; total NIA 0.401 0.401 0.401 

of4 lb/A/yr) 

NIA= Not Applicable 

Values in bold show the EDWCs recommended for HED's acute ( 102 ppb) and chron ic (47.0 ppb) and cancer (33.6 

ppb) dietary risk assessment as they are considered protective of all the registered uses ofpronamide. 

The drinking water models and their descriptions are available at the EPA internet site: 

http://www.epa.gov/oppefed 1 /models/water/. 

Page 4of16 
Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

V. DEEM-FCID Program and Consumption Information 

Pronamide chronic dietary exposure assessments was conducted using the DEEM-FCID, Version 

3.1 6, which incorporates 2003-2008 consumption data from USDA's NHANES/WWEIA. The 

data are based on the reported consumption of more than 20,000 individuals over two nonconsecutive 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 avail able recipe translation fi les developed jointly by 

USDNARS 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 (<I year old), children 1-2, 

children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years 

old. 

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodfonn (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 fonn 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. 

VI. Toxicological Information 

Toxicity endpoints and points of departure (PODs) for dietary exposure scenarios to pronamide 

are summarized in Table 3. An acute reference dose (RID) for general population was selected 

based on an acute neurotoxicity study in rats that showed reduced motor activity in both genders 

and increase in foot splay in females on day 1. An uncertainty factor of I OOOx (I Ox to account 

for interspecies extrapolation, and 1 Ox for intraspecies variation 1 Ox for FQPA) was applied to 

the acute RID. This results in a PoD of 4 mg/kg/day. There are no endpoints that could be used 

for an acute RfD for females aged 13-49. The chronic RID also used the extrapolated POD of 4 

mg/kg/day based on the acute neurotoxicity study which is protective of potential tumors as 

supported by the chronic toxicity/carcinogenicity study. Pronamide is classified as "Not Likely 

to be Carcinogenic to Humans" at doses that do not result in induction of hepatic cell 

proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endocrine axes. 

Page 5of16 
Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

Table 3. Summary of Toxicological Doses and Endpoints for Pronamide/Propyzamide for Use in Dietary 

and Non-Occupational Human Health Risk Assessments 

RID, PAD, 

Level of 

Uncertainty/ Concern for 

Exposure/ Point of FQPA Safety Risk 

Scenario Departure Factors Assessment Study and Toxicological Effects 

Acute Dietary NOAEL < UFA= I Ox aRfD=aPAD Acute neurotoxicity in rat: NOAEL was not 

(All 40 mg/kg UFu=IOx = 0.04 mg/kg established; LOA EL = 40 mg/kg (the 

Populations) Extrapolated lowest dose tested) based on the increase in 

P00 - 4 FQPA SF (UF1.) landing foot splay in female rats and the 

mg/kg/day = IOx decrease in motor activity seen in both 

genders on Day I . 

Acute Dietary An endpoint attributable to a single exposure was not available in the database including the 

Females 13- developmental toxicity studies in rats and rabbits. 

49 years of 

age 

Chronic Extrapolated UFA= I Ox Chronic RID The POD of 4 mg/kg/day was selected 

Dietary (All POD = 4 UF11= IOx = 0.04 based on a weight of evidence approach 

Populations) mg/kg/day FQPA SF (UFL) mg/kg/day using the results from the 3 studies listed 

from ACN below. = !Ox Subchronic ncurotoxicity (SCN}: NOAEL 

cPAD = 0.04 of2.38 mg/kg/day is based on the 

mg/kg/day significant decreases in body weight, body 

weight gain, and food consumption seen at 

11.28 mg/kg/day (LOA EL) in males. 

Acute ncurotox icitv (ACN}: NOAEL was 

not established. The LOA EL of 40 

mg/kg/day with a IOX LOAEL to NOAEL 

uncertainty factor (UFL) yields a POD of 4 

mg/kg/day (40+10). 

Combined chronic toxicity/ 

carcinogenicity NOA EL of 8.46/ 10.69 

mg/kg/day is based on increased relative 

liver weight and histopathological lesions in 

the liver, thyroid, and ovaries at 

42.59/55.09 mg/kg/day (LOAEL). 

Cancer (oral. Classification: "Not Likely to be Carcinogen ic to Humans" at doses that do not result in 

dermal, induction of hepatic cell proliferation or metabolic en=ymes leading to disruption of thyroid or 

inhalation) gonadal endocrine axes. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to 

mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOA EL 

= no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = 

extrapolation from animal to human (interspecies). UF11 = potential variation in sensitivity among members of the human 

population (intraspecies). UFL. = use of a LOA EL to extrapolate a NOAEL. UFs =use of a short-term tudy for long-term risk 

assessment. UFon = to account for the absence of key data (i.e .. lack ofa critical study). FQPA SF = FQPA Safety Factor. PAD 

= population adjusted dose (a = acute, c =chronic). RID = reference dose. MOE= margin of exposure. LOC = level of concern. 

NIA = not applicable. 

Page 6of 16 
Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

VII. Results/Discussion 

As stated above, for acute and chronic assessments, HEO 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 4 are for the general 

U.S. Population, all infants (< I year old), children 1-2, children 3-5, children 6-12, youth 13-1 9, 

females 13-49, adults 20-49, and adults 50-99 years. 

Results of Acute Dietmy (Food and Drinking Wate1) Exposure Analysis 

The results of the acute dietary exposure analysis at the 95th percentile of exposure are reported 

in the summary table below. An unrefined acute dietary risk assessment for pronamide showed 

that acute dietary risk estimates are below HED's level of concern (i.e. <100% aPAD) for the 

general population and all population subgroups. The highest risk was observed for All Infants 

( 46% of the aP AD). 

Results of Chronic Dietary (Food and Drinking Wate1) Exposure Analysis 

The results of the chronic dietary exposure analysis are reported in the summary table below. 

The chronic dietary risk assessment for pronamide showed that chronic dietary risk estimates are 

below HED's level of concern (i.e.> 100% cPAD) for the general population and all population 

subgroups; in particular, children 1-2 year old were the highest exposed population subgroup 

(11% of the cPAD). 

Table 4. Summary of Dietary (Food and Drinking Water) Exposure and Risk for 

Pronamide. 

Acute Dietary Chronic Dietary (951

h Per centile) Population Subgroup Dietary Exposure Dieta ry Exposur e 

l!/ 1~ av) % aPAD* (m2/kl!/dav) % cPAD* 

General U.S. Population 0.007144 18 0.001706 4.3 

All In fants(< I year old) 0.01 8539 46 0.003854 9.6 

Children 1-2 years old 0.0 13317 33 0.004410 11 

Children 3-5 years old 0.010013 25 0.003083 7.7 

Children 6-12 years old 0.006963 17 0.001804 4.5 

Youth 13-19 years old 0.005480 14 0.00 124 1 3. 1 

Adults 20-49 years old 0.006570 16 0.001534 3.8 

Adu lts 50-99 years old 0.005893 15 0.001526 3.8 

Females 13-49 years old 0.006753 17 0.001558 3.9 

VIII. Cha r acterization of Inputs/Outputs 

The acute and chronic dietary exposure assessments for pronamide are unrefined, making use of 

tolerance level residue levels, DEEM default processing factors, and 100% crop treated 

assumptions for all crops. In addition, a Tier If analysis using the SWCC was conducted to 

establish the EDWCs used in the assessment. This conservative analysis proved adequate for the 

Page 7of16 
Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

acute and chronic dietary assessments, as the acute and chronic risk for the population subgroup 

with the highest risk associated were 45% of the aPAD (All Infants < I year old) and 11% of the 

cPAD (Children 1-2 years old). For comparison purposes, the acute and chronic analyses 

considering food only are included in Attachment I. 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 and chronic dietary risk assessment were performed using DEEM-FCIDTM to 

support the registered and proposed uses of pronamide. Pronamide was classified by the CARC 

as "Not Likely to be Carcinogenic to Humans". Based on this a cancer risk assessment is no 

longer necessary. Tolerance level residues (residues convertible to methyl 3,5-dichlorobenzoate), 

DEEM defau lt processing factors, and 100% CT assumptions were used in the analyses. In 

addition, a Tier ll drinking water assessment using the SWCC was used to establish the EDWCs 

used in the assessment. The dietary risks are below HED's level of concern for the general 

population and all population subgroups. These assessments could be refined by the use of 

percent of crop treated assumptions, crop field trial data and monitoring data; however, as there 

are no risks concern refinement is not necessary. Overall, HED is confident that the assessment 

does not underestimate risk to the general U.S. population or any population subgroup. 

X. List of Attachments 

• 

• 

Acute Residue Input file 

Acute Results file 

Chronic Residue Input fi le 

Chronic Results File 

Page 8of16 
Pronamide Dietary Exposure and Risk Assessment 

Attachment 1. Dietary Assessment Input Files and Results 

Acute Dietary Assessment 

Acute Input File 

Filename: F:\Dietary Assessments\Pronamide\Pronamide 2014 

AcuteDietary_FoodWater_ToleranceLevel.R08 

Chemical: Pronamide 

RfD(Chronic): . 04 mg/kg bw/day NOEL(Chronic): O mg/kg bw/day 

RfD(Acute) : . 04 mg/kg bw/day NOEL(Acute): o mg/kg bw/ day 

DP Number: D427082 

Date created/last modified: 05 - 14-2015/10:16 : 04 Program ver. 3.16, 03-08-d 

Comment: Old & new uses + water 

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment 

Code Grp Commodity Name (ppm) #1 #2 

---------- ------------------------------- ---------- ------- 0401150000 4A Endive 1 . 000000 1 . 000 1.000 

0401204000 4A Lettuce, head 1.000000 1 . 000 1.000 

0401205000 4A Lettuce, leaf 2.000000 1. 000 1.000 New us 

Full comment : New use 

0401313000 4A Radicchio 2 . 000000 1 . 000 1. 000 

0402322000 48 Rhubarb 0 .100000 1 . 000 1.000 

0603256000 6C Pea, dry 0 . 100000 1 . 000 1.000 

0603256001 6C Pea, dry-baby food 0 . 100000 1.000 1. 000 

1100007000 11 Apple, fruit with pee l 0 . 100000 1 . 000 1. 000 

1100008000 11 Apple, peeled fruit 0 .100000 1 .000 1. 000 

1100008001 11 Apple, peeled fruit -babyfood 0 .100000 1 . 000 1.000 

110 0009000 11 Apple, dried 0 .100000 8 . 000 1.000 

1100009001 11 Apple, dried-babyfood 0 . 100000 8 . 000 1.000 

1100010000 11 Apple, juice 0 .100000 1 .300 1 .000 

1100010001 11 App le, juice-babyfood 0 . 100000 1 .300 1. 000 

1100011000 11 Apple, sauce 0 . 100000 1 . 000 1.000 

1100011001 11 Apple, sauce-babyfood 0.100000 1 . 000 1 . 000 

1100266000 11 Pear 0.100000 1 . 000 1.000 

1100266001 11 Pear-baby food 0 .100000 1 . 000 1 .000 

1100267000 11 Pear, dried 0 .100000 6.250 1.000 

1100268000 11 Pear, juice 0 .100000 1 . 000 1. 000 

1100268001 11 Pear, juice-baby food 0.100000 1 . 000 1.000 

1201090000 12A Cherry 0 .100000 1 . 000 1. 000 

1201090001 12A Cherry-babyf ood 0 .100000 1 .000 1. 000 

120109 1000 12A Cherry, JU1Ce 0.100000 1.500 1 .000 

1201091001 12A Cherry, juice-babyfood 0 . 100000 1. 500 1.000 

1202012000 128 Apricot 0.100000 1 . 000 1.000 

1202012001 128 Apricot-babyfood 0 .100000 1 . 000 1 . 000 

1202013000 12B Apricot, dried 0 .100000 6.000 1 . 000 

1202014000 12B Apricot, juice 0.100000 1 . 000 1 .000 

1202014001 128 Apricot, juice- babyfood 0 .100000 1.000 1 . 000 

1202230000 128 Nectarine 0.100000 1.000 1.000 

1202260000 128 Peach 0.100000 1. 000 1 . 000 

1202260001 128 Peach- baby f ood 0 .100000 1 .000 1 . 000 

1202261000 12B Peach, dried 0.100000 7.000 1 .000 

1202261001 12B Peach, dried-babyfood 0.100000 7 . 000 1 . 000 

1202262000 128 Peach, juice 0.100000 1.000 1.000 

1202262001 12B Peach, juice-babyfood 0.100000 1 . 000 1.000 

1203285000 12C Plum 0 .100000 1. 000 1 . 000 

1203285001 12C Plum-babyfood 0 . 100000 1. 000 1 . 000 

1203286000 12C Plum, prune, fres h 0.100000 1. 000 1.000 

1203286001 12C Plum, prune, fresh-babyfood 0.100000 1. 000 1.000 

1203287000 12C Plum, prune, dried 0.100000 5 . 000 1.000 

1203287001 12C Plum, prune, dried-baby food 0 .100000 5 . 000 1 . 000 

1203288000 12C Plum, prune, juice 0.100000 1.400 1.000 

1203288001 12C Plum, prune , juice-babyfood 0.100000 1.400 1.000 

1301055000 13A Blackberry 0.050000 1 . 000 1.000 

1301056000 13A Blackberry, juice 0.050000 1 . 000 1.000 

Page 9of 16 
Pronamide Dietary Exposure and Risk Assessment DP Number: 0 427082 

13010S6001 13A Blackberry, juice-babyfood o.osoooo 1.000 1 . 000 

13010S8000 13A Boysenberry o.osoooo 1.000 1.000 

1301320000 13A Raspberry o.osoooo 1.000 1.000 

1301320001 l3A Raspberry- baby food o.osoooo l.000 l.000 

1301321000 13A Raspberry, JUl.Ce o.osoooo 1 . 000 1.000 

1301321001 13A Rasp berry, juice-babyfood o.osoooo l . 000 1 . 000 

13020S7000 13B Blueberry o.osoooo l. 000 1 . 000 

1302057001 138 Blueberry-babyfood 0.050000 1.000 1.000 

1304175000 130 Grape 0.100000 1.000 l.000 

1304176000 130 Grape, juice 0.100000 1 . 200 l.000 

1304176001 130 Grap e, juice-babyfood 0 . 100000 1 . 200 1.000 

1304179000 130 Gra pe , wine and sherry 0 .100000 l. 000 1. 000 

3100044000 31 Beef, meat 0 . 020000 l. 000 1 . 000 

3100044001 31 Beef, meat-babyfood 0.020000 l. 000 1.000 

310004SOOO 31 Beef, meat, dried 0.020000 1 . 920 1.000 

3100046000 31 Beef, meat byproducts 0.020000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.020000 1.000 1.000 

3100047000 31 Beef , fat 0 . 200000 1 . 000 1 . 000 

3100047001 31 Beef, fat-babyfood 0.200000 1 . 000 1 . 000 

3100048000 31 Beef, kidney 0 .400000 1.000 1.000 

3100049000 31 Beef, liver 0.400000 1.000 1.000 

3100049001 31 Beef , liver-baby food 0.400000 1.000 1.000 

3200169000 32 Goat, meat 0.020000 1.000 1.000 

3200170000 32 Goat , meat byproducts 0 . 020000 1 . 000 1.000 

3200171000 32 Goat , fat 0.200000 l. 000 1 . 000 

3200172000 32 Goat, kidney 0 .400000 l.000 1. 000 

3200173000 32 Goat, liver 0.400000 l. 000 1.000 

3300189000 33 Horse, meat 0.020000 l.000 1.000 

3400292000 34 Pork, meat byproducts 0.020000 1.000 1.000 

3400292001 34 Pork, meat byproducts-babyfood 0.020000 l.000 1.000 

34 00293000 34 Pork, fat 0 . 200000 1 . 000 1 . 000 

3400293001 34 Pork, fat-babyfood 0.200000 1 . 000 1. 000 

3400294000 34 Pork, kidney 0 .400000 1 . 000 1.000 

3400295000 34 Pork, liver 0.400000 1.000 l. 000 

3500339000 3S Sheep, meat 0.020000 1.000 1.000 

3S00339001 35 Shee p, meat-babyfood 0.020000 1. 000 1.000 

3S00340000 3S Sheep, meat byproducts 0 . 020000 1.000 1.000 

3S00341000 3S Sheep , fat 0 . 200000 1 . 000 1.000 

3S0034100l 3S Sheep, fat-babyfood 0 . 200000 l . 000 1.000 

3S00342000 3S Sheep, kidney 0.400000 l.000 1. 000 

3500343000 3S Sheep, liver 0.400000 1.000 1.000 

3600222000 36 Milk, fat 0.020000 1. 000 1. 000 

3600222001 36 Milk, fat-baby food/infant formu 0 . 020000 1 . 000 1.000 

3600223000 36 Milk, nonfat solids 0 . 020000 1.000 1. 000 

3600223001 36 Milk, nonfat solids-baby food/in 0 . 020000 l . 000 1.000 

3600224000 36 Milk, water 0 . 020000 1.000 1.000 

3600224001 36 Milk, water-babyfood/infant form 0.020000 l.000 1.000 

3600225001 36 Milk, sugar (lactose)-baby food/ 0.020000 1.000 1.000 

3900312000 39 Rabbit, meat 0 . 020000 1.000 1.000 

4000093000 40 Chicken, meat 0 . 020000 1 . 000 1. 000 

4000093001 40 Chicken, meat-babyfood 0.020000 l.000 1.000 

4000094000 40 Chicken, liver 0.200000 l.000 1.000 

400009SOOO 40 Chicken, meat byproducts 0.020000 1.000 1.000 

4000095001 40 Chicken, meat byproducts-babyfoo 0.020000 1.000 1 . 000 

4000096000 40 Chicken, fat 0.020000 1. 000 1.000 

4000096001 40 Chicken, fat-babyfood 0 . 020000 1.000 1.000 

4000097000 40 Chicken, skin 0 . 020000 l.000 1.000 

4000097001 40 Chicken, skin-babyfood 0.020000 1.000 1.000 

S000382000 so Turkey, meat 0.020000 1.000 1.000 

S00038200l so Turkey, meat-babyfood 0.020000 1.000 1.000 

S000383000 so Turkey, liver 0.200000 1.000 1.000 

5000383001 so Turkey, liver-babyfood 0 . 200000 1.000 1 . 000 

5000384000 50 Turke y , meat b yprodu cts 0 . 020000 1. 000 1 . 000 

S000384001 so Turkey, meat byproducts-babyfood 0.020000 1. 000 1. 000 

500038SOOO so Turkey, fat 0 . 020000 1.000 1.000 

S00038500l so Turkey, fat - baby food 0.020000 1.000 1.000 

S000386000 so Turkey, skin 0.020000 1.000 1 . 000 

Page 10 of16 
Pronamidc Dietary Exposure and Risk Assessment DP Number: D427082 

5000386001 so Turkey, skin-babyfood 0.020000 1.000 1. 000 

6000301000 60 Poultry, other, meat 0.020000 1 . 000 1.000 

6000302000 60 Poultry, other, liver 0 . 200000 1. 000 1. 000 

6000303000 60 Poultry, other, meat byproducc:s 0.020000 1.000 1.000 

6000304000 60 Poultry, other, fat 0 . 020000 1.000 1. 000 

6000305000 60 Poul try, other, ski n 0.020000 1.000 1. 000 

7000145000 70 Egg, whole 0.020000 1.000 1.000 

7000145001 70 Egg, whole-babyfood 0 . 020000 1.000 1.000 

7000146000 70 Egg, white 0.020000 1. 000 1.000 

7000146001 70 Egg, white (solids)-babyfood 0 . 020000 1. 000 1.000 

7000147000 70 Egg, yolk 0.020000 1. 000 1.000 

7000147001 70 Egg, yolk-baby food 0 . 020000 1.000 1.000 

8601000000 86A water, direct, all sources 0.102000 1. 000 1.000 Surfac 

Full comment : Surface Water Lettuce Scenario 

8602000000 868 water, indirect , all sources 0 . 102000 1.000 1. 000 Surfac 

Full comment:: Surface Water Lec:tuce Scenario 

9500016000 0 Arc:ichoke, globe 0 . 010000 1 . 000 1.000 

9500054000 0 Belgium endive 2 . 000000 1 . 000 1.000 

9500177000 0 Grape, leaves 0 . 100000 1.000 1. 000 

9500178000 0 Grape, raisin 0.100000 4.300 1.000 

Acute Results 

l. Food and Water 

us EPA Ver. 3 . 18, 03-08-d 

DEEM-FCID ACUTE Analysis for PRONAMIDE NHANES 2003-2008 2-Day 

Residue file: Pronamide_2014 Acuc:eDietary_FoodWac:er_ToleranceLevel . R08 

Adjustment factor #2 NOT used. 

Analysis Date : 05-14-2015/10 : 21:10 Residue file dated : 05-14 - 2015/10:16 : 04 

RAC/FF intake summed over 24 hours 

Run Comment : "Old & new uses + wac:er" 

==============:========m========== ============ ================================= 

Summary calculations--per capita: 

95th Percentile 99th Percentile 99.9c:h Percentile 

Exposure % aRf D Exposure % aRfD Exposure % aRfD 

---------- -------- ---------- -------- ---------- -------- Toc:al us Population: 

0.007144 17 . 86 0.011411 28.53 0.019370 48.42 

All Infants: 

0 . 018539 46 . 35 0.026244 65 . 61 0.035446 88 . 62 

Children 1-2: 

0.013317 33 .29 0 . 018993 47. 48 0 . 034326 85.82 

Children 3-5 : 

0.010013 25 . 03 0.014522 36.31 0 . 019238 48.10 

Children 6-12: 

0.006963 17 . 41 0 . 010501 26.25 0 . 015847 39 . 62 

Youth 13-19 : 

0. 005480 13 . 70 0 . 008700 21.75 0.012 4 56 31 .14 

Adults 20-49: 

0.006570 16 . 42 0.009614 24 . 04 0. 013010 32.52 

Adults 50-99: 

0.005893 14 . 73 0 . 008513 21. 28 0.011946 29.86 

Female 13-49 : 

0.006753 16 .88 0 . 009907 24.77 0.013020 32.55 

Page 11 of l6 
Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

2. Food Only 

US EPA 

DEEM-FCID ACUTE Analysis for PRONAMIDE 

Residue file: Pronamide_2014 AcuteDietary_Food 

Ver. 3.18, 03-08-d 

NHANES 2003-2008 2-Day 

Only_ToleranceLevel.R08 

Adjustment factor #2 NOT used . 

Analysis Date : 05-14-2015/10 : 35 :16 

RAC/FF intake summed over 24 hours 

Run Comment: "Old & new uses + water" 

Residue file dated: 05-14-2015/10:31 : 58 

========================================================•=&==================== 

Summary calculations--per capita: 

95th Percentile 99th Percentile 

Exposure % aRfD Exposure % aRf D 

---------- -------- ---------- -------- Total us Population: 

0.002604 6.51 0.005170 12.93 

All Infants: 

0.004601 11.50 0 . 008300 20.75 

Children 1-2 : 

0.007317 18.29 0 . 01208 6 30.22 

Children 3-5 : 

0.005154 12.89 0.008161 20 .40 

Children 6-12 : 

0. 002716 6.79 0.005349 13.37 

Youth 13-19 : 

0 . 001725 4 . 31 0 .003080 7.70 

Adults 20-49 : 

0 . 001970 4 . 93 0 . 003680 9.20 

Adults 50-99: 

0 . 001891 4 . 73 0 . 003327 8.32 

Fema le 13-49 : 

0 . 002091 5.23 0 . 004009 10.02 

Chronic Dietary Assessment 

Chronic Input File 

Filename: F:\Dietary Assessments\Pronamide\Pronamide 2014 

ChronicDietary_FoodWater_ToleranceLeve l .R08 

Chemical: Pronamide 

99.9th Percentile 

Exposure \ aRf D 

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

0 . 009606 24.02 

0 . 013269 33 .17 

0 . 017450 43.62 

0 . 011395 28 . 46 

0.006475 16 .19 

0 . 006818 17 . 04 

0.006604 16.51 

0 . 005471 13 .68 

0 . 006969 17.42 

RfD (Chronic) : . 04 mg/kg bw/day NOEL (Chronic) : O mg/ kg bw/day 

RfD(Acute) : .04 mg/kg bw/day NOEL(Acute) : o mg/kg bw/day 

Date created/last modified : 05 -14 -2 015/10:18 : 50 Program ver. 3.16, 03-08-d 

Comment: Old & new uses + water 

EPA Crop Def Res Adj.Factors Comment 

Code Grp Commodity Name (ppm) jj 1 112 

---------- ---- --------------------------- ---------- ------- 0401150000 4A Endive 1.000000 1.000 1.000 

0401204000 4A Lettuce, head 1. 000000 1.000 1.000 

0401205000 4A Lettuce, leaf 2.000000 1 .000 1.000 New Us 

Full comment: New use 

0401313000 4A Radicchio 2 . 000000 1.000 1.000 

0402322000 48 Rhubarb 0 . 100000 1 . 000 1. 000 

0603256000 6C Pea, dry 0 . 100000 1 . 000 1 . 000 

0603256001 6C Pea, dry-baby food 0 . 100000 1 . 000 1.000 

1100007000 11 Apple, fruit with peel 0.100000 1 . 000 1.000 

1100008000 11 Apple, peeled fruit 0.100000 1. 000 1 . 000 

Page 12 of 16 
Pronamide 

1100008001 11 

1100009000 11 

1100009001 11 

1100010000 11 

1100010001 11 

1100011000 11 

1100011001 11 

1100266000 11 

1100266001 11 

1100267000 11 

1100268000 11 

1100268001 ll 

1201090000 12A 

1201090001 l2A 

1201091000 12A 

1201091001 12A 

1202012000 12B 

1202012001 12B 

1202013000 12B 

1202014000 l2B 

1202014001 129 

1202230000 129 

1202260000 12B 

1202260001 129 

1202261000 12B 

1202261001 l2B 

1202262000 12B 

1202262001 12B 

1203285000 12C 

1203285001 12C 

1203286000 12C 

1203286001 l2C 

1203287000 12C 

1203287001 12C 

1203288000 12C 

1203288001 12C 

1301055000 13A 

1301056000 l3A 

1301056001 13A 

1301058000 13A 

1301320000 13A 

1301320001 13A 

1301321000 13A 

1301321001 13A 

1302057000 13B 

1302057001 13B 

1304175000 130 

1304176000 130 

1304176001 130 

1304179000 130 

3100044000 31 

3100044001 31 

3100045000 31 

3100046000 3l 

3100046001 31 

3100047000 31 

3100047001 31 

3100048000 3l 

3100049000 31 

3100049001 31 

3200169000 32 

3200170000 32 

3200171000 32 

3200172000 32 

3200173000 32 

3300189000 33 

3400292000 34 

Dietary Exposure and Risk Assessment 

Apple, peeled fruit-babyfood 

Apple, dried 

Apple , dried-babyfood 

Apple , j uice 

Apple, juice-babyfood 

Apple, sauce 

Apple, sauce-babyfood 

Pear 

Pear-babyfood 

Pear, dried 

Pear, juice 

Pear, juice -babyfood 

Cherry 

Cherry-baby food 

Cherry, Juice 

Cherry, juice-babyfood 

Apricot 

Apricot-babyfood 

Apricot, dried 

Apricot, juice 

Apricot, juice-babyfood 

Nectarine 

Peach 

Peach-babyfood 

Peach, dried 

Peach, dried-babyfood 

Peach, juice 

Peach, juice-babyfood 

Plum 

Plum-babyfood 

Plum, prune, fresh 

Plum, prune, fresh-babyfood 

Plum, prune, dried 

Plum, prune , dried-babyfood 

Plum, prune, juice 

Plum, prune, juice-babyfood 

Blackberry 

Blackberry. juice 

Blackberry, juice-babyfood 

Boysenberry 

Raspberry 

Raspberry-baby food 

Raspberry, Juice 

Raspberry, juice-babyfood 

Blueberry 

Blueberry-baby food 

Grape 

Grape, juice 

Grape, juice-babyfood 

Grape, wine and sherry 

Beef, meat 

Beef, meat.-babyfood 

Beef, meat, dried 

Beef, meat byproducts 

Beef, meat byproduct.s-babyfood 

Beef, fat 

Beef, fat-babyfood 

Beef, kidney 

Beef, liver 

Beef, liver-babyfood 

Goat, meat 

Goat, meat byproducts 

Goat, fat 

Goat, kidney 

Goat, liver 

Horse, meat 

Pork, meat byproducts 

0 . 100000 

0 .100000 

0.100000 

0.100000 

0.100000 

0.100000 

0 .100000 

0 .100000 

0 .100000 

0.100000 

0 .100000 

0.100000 

0.100000 

0 . 100000 

0 .100000 

0 . 100000 

0 . 100000 

0 . 100000 

0 .100000 

0.100000 

0 . 100000 

0 .100000 

0 .100000 

0.100000 

0.100000 

0 . 100000 

0 .100000 

0.100000 

0 . 100000 

0 .100000 

0.100000 

0 .100000 

0.100000 

0 .100000 

0 .100000 

0 .100000 

0.050000 

0.050000 

0.050000 

0.050000 

0 . 050000 

0 . 050000 

0 .050000 

0 . 050000 

0.050000 

0.050000 

0 .100000 

0.100000 

0 . 100000 

0 . 100000 

0 . 020000 

0 . 020000 

0.020000 

0 . 020000 

0 . 020000 

0.200000 

0.200000 

0 . 400000 

0 .4 00000 

0 . 400000 

0.020000 

0 . 020000 

0 . 200000 

0.400000 

0.400000 

0 .020000 

0.020000 

Page 13ofl6 

DP Number: D427082 

1 . 000 

8 . 000 

8.000 

1. 300 

1 . 300 

1.000 

1. 000 

1 . 000 

1. 000 

6 . 250 

1.000 

1. 000 

1 . 000 

1. 000 

1.500 

1 . 500 

1 . 000 

1 .000 

6.000 

1.000 

1 . 000 

1.000 

1. 000 

1 . 000 

7 . 000 

7 . 000 

1. 000 

1. 000 

1. 000 

1 . 000 

l . 000 

1 . 000 

5 . 000 

5.000 

1.400 

1.400 

1 . 000 

1 . 000 

1 . 000 

1.000 

1 . 000 

1.000 

1 . 000 

1. 000 

1. 000 

1 . 000 

1. 000 

1. 200 

1. 200 

1 . 000 

1.000 

1 . 000 

1 .920 

1 . 000 

1.000 

1.000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1. 000 

1 . 000 

1.000 

1. 000 

1. 000 

1.000 

1.000 

1 .000 

1. 000 

1. 000 

1.000 

1 .000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1 . 000 

1 .000 

1 . 000 

1. 000 

1 . 000 

1.000 

1.000 

1 . 000 

1 .000 

1.000 

1. 000 

1. 000 

1.000 

1.000 

1.000 

1 . 000 

1. 000 

1 . 000 

1. 000 

l.000 

1.000 

1 . 000 

l.000 

1. 000 

1. 000 

1 . 000 

1.000 

1.000 

1.000 

1. 000 

1. 000 

1. 000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1 . 000 

1 .000 

1.000 

1.000 

1 .000 

1 . 000 

1.000 

1.000 

1.000 
Pronamide Dietary Exposure and Risk Assessment 

3400292 001 34 Pork, meat byproducts-babyfood 0 . 020000 

3400293000 34 Pork , fat 0 . 200000 

340029300 1 34 Pork, fat-babyfood 0 .200000 

3400294000 34 Pork, k i dney o .400000 

3400295000 34 Pork, liver 0.400000 

3500339000 35 Sheep, meat 0.020000 

3500339001 35 Sheep, meat-babyfood 0.020000 

3500340000 35 Sheep, meat byproducts 0 . 020000 

3500341000 35 Sheep, fat 0 .200000 

3500341001 35 Sheep, fat-babyfood 0 . 200000 

3500342000 35 Sheep, kidney 0 . 400000 

3500343000 35 Sheep, liver 0 . 400000 

3600222000 36 Milk, fat 0 . 020000 

3600222001 36 Milk, fat-baby food/infant formu 0 . 020000 

3600223000 36 Milk, nonfat solids 0 . 020000 

3600223001 36 Milk, nonfat solids- baby food/in 0 . 020000 

360022 4000 36 Milk , water 0.020000 

360022 4001 36 Milk, water- babyfood/infant form 0 . 020000 

3600225001 36 Milk, s ugar (lactose)-baby food/ 0 . 020000 

3900312000 39 Rabbit, meat 0 . 020000 

4000093000 40 Chicken, meat 0 .020000 

4000093001 40 Chicken, meat-babyfood 0 . 020000 

4000094000 40 Chicken, liver 0.200000 

4000095000 40 Chicken, meat byproducts 0.020000 

4000095001 40 Chicken, meat byproducts-babyfoo 0 . 020000 

4000096000 40 Chicken, fat 0.020000 

4000096001 40 Chicken, fat-babyfood 0 . 020000 

4000097000 4 0 Chicken, skin 0 . 020000 

4000097001 4 0 Chicken , skin-babyfood 0 . 020000 

5000382000 50 Turkey, meat 0 .020000 

5000382001 50 Turkey, meat - babyfood 0 . 020000 

5000383000 SO Turkey, liver 0 .200000 

5000383001 50 Turkey, liver-babyfood 0 .200000 

5000384000 50 Turkey, meat byproducts 0 .020000 

5000384 001 50 Turkey, meat byproducts-babyfood 0 . 020000 

5000385000 50 Turkey, fat 0.020000 

5000385001 50 Turkey, fat-babyfood 0 . 020000 

5000386000 50 Turkey, skin 0 . 020000 

5000386001 50 Turkey, skin-babyfood 0.020000 

6000301000 60 Poultry, other, meat 0 . 020000 

6000302000 60 Poultry, other, liver 0 .200000 

6000303000 60 Poultry, other, meat byproducts 0 . 020000 

6000304000 60 Poultry, other, fat 0 . 020000 

6000305000 60 Poultry, other, skin 0 .020000 

7000145000 70 Egg , whole 0.020000 

7000145001 70 Egg, whole-babyfood 0 . 020000 

7000146000 70 Egg, white 0 . 020000 

7000146001 70 Egg, white (solids)-babyfood 0 . 020000 

700014 7000 70 Egg, yolk 0 . 020000 

7000147001 70 Egg, yolk-babyfood 0 . 020000 

8601000000 86A Water, direct , all s ources 0 . 047000 

Full comment: Surface Water Lettuce Scenario 

8602000000 86B Water, indirect, all sources 0 . 047000 

Full comment: Surface Water Lettuce Scenario 

9500016000 O Artichoke , globe 0 . 010000 

9500054000 O Belgium e ndive 2 . 000000 

9500177000 0 Grape , l eaves 0.100000 

9500178000 O Grape , raisin 0.100000 

Page 14 of 16 

DP Number: D427082 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1. 000 

1. 000 

1.000 

1. 000 

1 . 000 

1.000 

1 . 000 

1.000 

1.000 

1 . 000 

1 . 000 

1.000 

1 . 000 

1.000 

1.000 

1 . 000 

1.000 

1.000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1. 000 

1. 000 

1.000 

1 . 000 

1.000 

1 . 000 

1 . 000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1 . 000 

1. 000 

1. 000 

4.300 

1.000 

1.000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1.000 

1.000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1.000 

1. 000 

1. 000 

1. 000 

1.000 

1.000 

1.000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1.000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1.000 

1 . 000 

1 . 000 

1.000 

1. 000 

1.000 

1 . 000 

1 .000 

1 . 000 

1.000 

1 . 000 

1.000 

1.000 

1 . 000 

1.000 

1.000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

Surfac 

Surfac 
Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

Chronic Results 

I. Food and Water 

us EPA Ver . 3.16, 03 - 08-d 

DEEM-FCID Chronic analysis for PRONAMIDE NHANES 2003-2008 2-day 

Residue file name: F : \Dietary Assessments\Pronamide\Pronamide_2014 

ChronicDietary_FoodWater_ToleranceLevel.R08 

Adjustment factor #2 NOT used. 

Analysis Date 05-14-2015/10:22:56 Residue file dated: 05-14-2015/10:18:50 

Reference dose (RfD, Chronic) = .04 mg/kg bw/day 

COMMENT 1 : Old & new uses +water 

===================================================3===:======================= 

Population 

Subgroup 

Total US Population 

Hispanic 

Non-Hisp-White 

Non-Hisp-Black 

Non-Hisp-Other 

Nursing Inf ants 

Non-Nursing Infants 

Female 13+ PREG 

Children 1-6 

Children 7 -1 2 

Male 13-19 

Female 13-19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1 - 2 

Children 3-5 

Children 6-12 

Youth 13-19 

Adults 20-49 

Adults 50-99 

Female 13-49 

Total exposure by population subgroup 

Total Exposure 

mg/kg 

body wt/day 

0.001706 

0 . 001718 

0.001741 

0.001434 

0 . 001852 

0 . 001611 

0.004855 

0.001557 

0.003471 

0.001667 

0 . 001190 

0.001290 

0.001429 

0.001622 

0 . 001505 

0 . 003854 

0.001559 

0.004410 

0.003083 

0.001804 

0.001241 

0.001534 

0 . 001526 

0.001558 

Page 15of 16 

Percent of 

Rfd 

4.3% 

4.3% 

4.4% 

3.6% 

4.6% 

4.0% 

12 .1% 

3.9% 

8.7% 

4.2% 

3 . 0% 

3.2% 

3.H 

4 .1% 

3 .8% 

9.6% 

3.9% 

11. 0% 

7.7% 

4.5% 

3 .1% 

3.8% 

3.8% 

J.9% 
Pronamide Dietary Exposure and Risk Assessment DP Number: 0427082 

2. Food Only 

us EPA Ver. 3.16, 03-08-d 

DEEM-FCID Chronic analysis for PRONAMIDE NHANES 2003-2008 2-day 

Residue file name: F : \Dietary Assessments\Pronamide\Pronamide_2014 

ChronicDietary_Food_ToleranceLevel.R08 

Adjustment factor #2 NOT used. 

Analysis Date 05-14-2015/10:44 :21 Residue file dated: 05-14-2015/10:32:46 

Reference dose (RfD, Chronic) = . 04 mg/kg bw/day 

COMMENT 1 : Old & new uses 

============================================================ === === =====•=== ==== 

Total exposure by population subgroup 

Population 

Subgroup 

Total US Population 

Hispanic 

Non-Hisp-White 

Non-Hisp-Black 

Non-Hisp-Other 

Nursing Inf ants 

Non-Nursing Infants 

Female 13+ PREG 

Children 1- 6 

Children 7-12 

Ma le 13-19 

Female 13-19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1-2 

Children 3-5 

Children 6-12 

Youth 13-19 

Adults 20-49 

Adults 50-99 

Female 13-49 

Total Exposure 

mg/kg Percent of 

body wt/day Rf d 

------------- ---------------- 0 . 000722 1. 8% 

0 .000778 1. 9\ 

0. 000729 1. 8% 

0 . 000622 1.6% 

0.000718 1.8% 

0. 000721 1.8% 

0 . 001582 4.0% 

0.000631 1. 6\ 

0.002210 5. 5% 

0 . 000847 2 . 1\-

0.000513 1.3% 

0.000532 1.3% 

0 . 000513 1.3% 

0.000588 1. 5% 

0 .000553 1.4% 

0.001316 3.3% 

0.000580 1.4% 

0. 002991 7.5\ 

0.001887 4. 7% 

0.000942 2 . 4% 

0.000523 1. 3% 

0.000552 1.4% 

0.000555 1.4% 

0 . 000580 1.4% 

Page 16of16