Fenamidone (046679) Dietary Exposure and Risk Assessment D391040 

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0.17 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM

DATE: July 7, 2011 

SUBJECT: Fenamidone – Acute and Chronic Aggregate Dietary (Food and Drinking 

Water) Exposure and Risk Assessments to Support the Label Amendment 

to Permit Rotation to All Cereal Grain, Except Rice and Establish Revised 

Tolerances for Inadvertent Residues. 

PC Code: 046679 DP Barcode: D391040 

MRID No.: None Registration No.: 264-695 

Petition No.: 0F7764 Regulatory Action: Section 3 Registration 

Assessment Type: Dietary Risk Assessment Reregistration Case No.: N/A 

TXR No.: N/A CAS No.: 161326-34-7

REVIEWER: Alexandra LaMay, Biologist 

Risk Assessment Branch VII 

Health Effects Division (7509P) 

THROUGH: Rebecca Daiss, Biologist 

Sheila Piper, Chemist 

Dietary Exposure Science Advisory Council (DESAC) 

Health Effects Division (7509P) 

 and 

Michael S. Metzger, Chief 

Risk Assessment Branch VII 

Health Effects Division (7509P) 

To: Rosemary Kearns 

 Tony Kish, PM 22 

 Registration Division (7505P) 
Fenamidone (046679) Dietary Exposure and Risk Assessment D391040 

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Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk 

assessments were conducted using the Dietary Exposure Evaluation Model DEEMFCIDTM, Version 2.03 which use food consumption data from the U.S. Department of 

Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-

1996 and 1998. The analyses were performed to support the Section 3 request to allow 

rotation to all crops, except rice, in the cereal crop groups (crop groups 15, except rice 

and crop group 16, except rice). 

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization

A conservative acute dietary risk assessment was conducted which used maximum field 

trial residue values, assumed 100 percent crop treated (% CT) for all commodities, 

incorporated DEEMTM default processing factors for many processed commodities and 

included modeled drinking water estimates. The estimated exposure (food and water) to 

the U.S. population from the existing and proposed new uses of fenamidone resulted in 

an estimated risk equivalent to 3% of the acute population adjusted dose (aPAD) at the 

95th percentile. The most highly exposed subpopulation was children 1 - 2 years with an 

estimated exposure equivalent to 5% of the aPAD at the 95th percentile. 

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

A conservative chronic dietary risk assessments was conducted which used maximum 

field trial residue values, assumed 100 % CT for all commodities, incorporated DEEMTM 

default processing factors for many processed commodities and included modeled 

drinking water estimates. The estimated exposure (food and water) to the U.S. 

population from the existing and proposed new uses of fenamidone resulted in an 

estimated risk equivalent to 52% of the chronic population adjusted dose (cPAD). The 

most highly exposed subpopulation was children 1 – 2 years with an estimated exposure 

equivalent to 90% of the cPAD. 

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Fenamidone is not likely to be a human carcinogen; therefore a cancer dietary risk 

assessment is not required for this chemical. 

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For 

acute and chronic assessments, the risk is expressed as a percentage of a maximum 

acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable 

adverse health effects). This dose is referred to as the population adjusted dose (PAD). 

The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by 

the required uncertainty or safety factors. 

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

risk exceeds 100% of the PAD. HED is generally concerned when estimated cancer risk 

exceeds one in one million. References which discuss the acute and chronic risk 
Fenamidone (046679) Dietary Exposure and Risk Assessment D391040 

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assessments in more detail are available on the EPA/pesticides web site: “Available 

Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, 

web link: http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see 

SOP 99.6 (20-AUG-1999). 

The most recent dietary risk assessment for fenamidone was conducted by Donna Davis 

(D362172, 2/23/09). 

II. Residue Information 

Tolerances are currently established for residues of fenamidone per se under 40 CFR 

180.579 (a)(1) for a variety of primary crops including bulb vegetables, cucurbit 

vegetables, tuberous and corm vegetables, brassica vegetables, leafy vegetables, fruiting 

vegetables, cotton, non bell pepper, sunflower, and tomato ranging from 0.02 ppm to 60 

ppm. Animal commodity tolerances are established for residues of fenamidone and RPA 

717879 (DADK-Fen) in milk, fat, meat and meat byproducts under 180.579(a)(2). 

Rotational crop tolerances are established for residues of fenamidone and RPA 717870 

(DADK-Fen) in wheat, corn and soybean commodities and strawberries ranging from 

0.02 ppm to 0.50 ppm under 40CFR 180.579(d). 

The residues of concern for tolerance setting and risk assessment purposes are 

summarized in the table below. 

Table 1: Residues of Concern in Primary Crops, Livestock, Rotational Crops, and Water

Matrix Tolerance Expression Residues for Risk Assessment 

Registered/proposed primary crops 

excluding root vegetables fenamidone fenamidone, RPA 717879 (DADK-Fen), RPA 408056 

(DA-Fen), RPA 405862 

Root vegetables fenamidone fenamidone, RPA 413255 

Animal commodities fenamidone, RPA 717879 

(DADK-Fen) 

fenamidone, RPA 717879 (DADK-Fen), RPA 408056 

(DA-Fen) 

Rotational Crops fenamidone, RPA 717879 

(DADK-Fen) 

fenamidone, RPA 717879 (DADK-Fen), and RPA 

408056 (DA-Fen) (free and conjugated) 

Water NA Fenamidone, RPA 412636, RPA 412708, RPA 411639, 

RPA 413255, RPA 409446, and RPA 410995 

Residue Data used for Acute and Chronic Assessments

Since the residue of concern for tolerance setting purposes and for risk assessment 

differs, HED has not used tolerance level residues for these assessments. Residues for 

plant commodities are based on maximum field trial values of parent plus metabolites. 

For animal commodities, LOQ residues are assumed as detailed in the T. Bloem 

memorandum dated 7/14/07 (D336201). No new residue data were submitted to support 

the new rotational crop tolerances on cereal grains (crop group 15 and 16, except rice). 

Therefore, residues for dietary risk assessment for these rotational crops were derived 

based on translation from existing rotational crop field trials data for wheat and corn. 

However, since the analytical method used to detect residues of fenamidone was not 

validated for detection of DA-Fen conjugate; HED has derived a ratio between residues 

of DADK-Fen and the DA-Fen conjugate based on available rotational crop metabolism 
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data. That ratio is applied to the DADK-Fen residues from the rotational crop field trials 

and then added to total parent and DADK-Fen residues directly measured in the 

rotational field trial data to estimate total residues of concern in rotational crops. The 

new rotational crop residues were included in the acute and chronic dietary risk 

assessment and a description of how they were calculated are shown in Table 2. 

DEEM (ver. 7.81) default processing factors were maintained for all commodities 

excluding grape juice, dried potato, tomato paste, tomato puree, field corn processed 

commodities and soybean processed commodities. For these commodities, the DEEM

default processing factors were reduced to 1 based on processing data (grape), were 

reduced to 1 based on the application of empirical processing factors to the RAC residue 

(tomato paste, tomato puree, and dried potato; D277818, T. Bloem, 4/22/04), or were 

reduced to 1 based on lack of residues at exaggerated rates in the RAC (field corn 

processed commodities and soybean processed commodities; D357372, A. LaMay, 

2/24/09). 

For all commodities, 100 percent crop treated was assumed. 

Table 2. Summary of New Residue Values Added to the Acute and Chronic Dietary Risk Assessment 

Crop/Commodity* Residue Value 

(ppm) Comment 

Cereal grains, Crop Group 

15 and 16 (except rice) 

which includes: barley, 

buckwheat, corn [pop], 

millet, oats, rye, sorghum, 

teosinte, triticale, wheat. 

0.594 

Translated from wheat data. The field rotational crop 

studies monitored for residues of fenamidone, RPA 717879, 

and free RPA 408056 with a highest combined residues in 

wheat grain of 0.075 ppm; residues of conjugated RPA 

408056 were estimated in wheat grain using the conjugated 

RPA 408056:RPA 717879 residue ratio for wheat grain 

from the confined rotational crop study (30-day PBI ratio = 

8.5) and the max RPA 717879 residue (0.061 ppm) from the 

field rotational crop studies (0.075 + 0.061 x 8.5 = 0.594 

ppm; D281887, T. Bloem, 18-Jul-2002) 

Field Corn and processed 

commodities 0.218 

 Maximum rotational crop field corn residue data reported 

<0.02 ppm for fenamidone and <0.02 ppm for combined 

residues of RPA 717879 and RPA 405862 (free). Residues 

of conjugated RPA 405862 were not reported, but are a 

residue of concern in rotational crops. Residues of RPA 

405862 were 8.5x residues of RPA 717879 from the wheat 

confined rotational crop study. Total residue of concern for 

field corn and processed commodities is calculated as 0.02 

ppm (fenamidone) + 0.02 ppm (RPA 717879 and free RPA 

405862) + 0.02 x 8.9 (ratio to yield conjugated RPA 

405862) = 0.218 (D357372, A. LaMay, 2/24/09). 

Sweet Corn (K + CWHR) 0.218 

Maximum rotational crop sweet corn (K+CWHR) residue 

data reported <0.02 ppm for fenamidone and <0.02 ppm for 

combined residues of RPA 717879 and RPA 405862 (free). 

Residues of conjugated RPA 405862 were not reported, but 

are a residue of concern in rotational crops. Residues of 

RPA 405862 were 8.5x residues of RPA 717879 from the 

wheat confined rotational crop study. Total residue of 

concern for sweet corn (K+CWHR) is calculated as 0.02 

ppm (fenamidone) + 0.02 ppm (RPA 717879 and free RPA 

405862) + 0.02 x 8.9 (ratio to yield conjugated RPA 

405862) = 0.218 (D357372, A. LaMay, 2/24/09). 
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*Although there are not separate tolerances for the cereal grains, the residue data for corn were used in the 

dietary assessment since specific residue data are available for these crops. Residue data for wheat were 

used for all other cereal grains for the purposes of the dietary assessment. 

 

III. 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: 

“Fenamidone - Interregional Research Project No. 4 (PR#07975, 08164) Drinking Water 

Assessment for Total Residues in Surface and [Ground] Water for Uses on Root 

vegetables (except sugar beet; Subgroup 1B, except radishes), okra, turnip greens, 

cilantro, and grapes East of the Rockies” (James Hetrick, D352807, 10/9/08) and were 

incorporated directly into the acute and chronic dietary assessments. Water residues were 

incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and 

“water, indirect, all sources.” 

Monitoring data are not available for residues of fenamidone and its metabolites in water; 

therefore EFED has provided modeled values for ground and surface water. The 

modeled EDWCs (estimated drinking water concentrations) are reported for parent and 

its degradation products, RPA-412636, RPA-412108, RPA-411639, RPA-413255, RPA409446, and RPA- 410995. These are the residues of concern in drinking water, as 

determined by the Metabolite Assessment Committee (MARC, 05/25/04). Surface water 

EDWCs were calculated using a Tier II model for surface water PRZM (Version 3.122) 

and EXAMS (Version 2.98.04) using the PE5 platform. The EDWC in ground water 

were estimated using SCI-GROW (Version 2.3). EDWCs in surface source water were 

corrected using the default percent crop area factor (0.87). The default PCA was applied 

because fenamidone can be used on numerous crops. No water treatment effects were 

considered in this assessment. These models and their descriptions are available at the 

EPA internet site: http://www.epa.gov/oppefed1/models/water/. 

The maximum Tier II EDWCs of total fenamidone residues in surface source water are 

not expected to exceed 47.88 μg/L for the 1 in 10 year daily peak concentration, 12.86 

μg/L for the 1 in 10 year annual average concentration, and 6.89 μg/L for the 30 year 

annual average concentration. The maximum concentration of total fenamidone residues 

in shallow groundwater are not expected to exceed 178 μg/L. 

For both the acute and chronic dietary analysis, HED will use the maximum ground water 

EDWC of 178 μg/L (0.178 ppm), since it is the highest EDWC reported for fenamidone. 

IV. DEEM-FCIDTM Program and Consumption Information

Fenamidone acute and chronic dietary exposure assessments were conducted using the 

Dietary Exposure Evaluation Model software with the Food Commodity Intake Database 

DEEM-FCIDTM, Version 2.03 which incorporates consumption data from USDA’s 

Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. The 

1994-96, 98 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 
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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, but for acute exposure assessment are retained as individual consumption 

events. Based on analysis of the 1994-96, 98 CSFII 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 chronic dietary exposure assessment, an estimate of the residue level in each food or 

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

by the average daily consumption estimate for that food/food form to produce a residue 

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

with the residue intake estimates for all other food/food forms on the commodity residue 

list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg 

body weight/day and as a percent of the cPAD. This procedure is performed for each 

population subgroup. 

For acute exposure assessments, 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 percapita (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 

all tiers of analysis. However, for tiers 1 and 2, any significant differences in user vs. per 

capita exposure and risk are specifically identified and noted in the risk assessment. 

V. Toxicological Information 

The HED Hazard Identification and Assessment Review Committee (HIARC) met on 18-

March-2003 to evaluate the toxicological database for fenamidone (TXR No. 0052379). 

At that meeting the lack of a developmental neurotoxicity study was indentified and a 

10X database uncertainty factor was applied. Subsequent to that finding, the registrant 

has addressed the data gap, and HED has determined that the database UF is no longer 

required. Based on toxicological considerations and the residue assumptions used in the 

dietary analyses, HED concludes that the FQPA Safety Factor can be reduced to 1x when 

assessing acute and chronic dietary exposures. Table 3 summarizes the points of 

departure used for dietary risk assessment. 

Table 3. Summary of Toxicological Doses and Endpoints for Fenamidone Dietary Exposure Assessment 
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Exposure 

Scenario Point of Departure Uncertainty/ 

FQPA SF RfD and PAD Study and Toxicological Effects 

Acute Dietary 

(All populations) 

NOAEL = 125 

mg/kg/day 

UFA= 10x 

UFH= 10x 

FQPA SF= 1 

Acute RfD = 1.25 

mg/kg/day 

Acute PAD = 1.25 

mg/kg/day 

Acute Neurotoxicity in Rats; LOAEL = 

500 mg/kg/day based on urination, 

staining/soiling of the anogenital region, 

mucous in the feces, and unsteady gait in 

the females 

Chronic Dietary 

(All populations) 

NOAEL= 2.83 

mg/kg/day 

UFA= 10x 

UFH= 10x 

FQPA SF= 1 

Chronic RfD = 

0.0283 mg/kg/day

Chronic PAD = 

0.0283 mg/kg/day

2 Year Chronic Toxicity/Carcinogenicity in 

Rats; LOAEL = 7.07/9.24 mg/kg/day 

(M/F) based on increase in severity of 

diffuse thyroid C-cell hyperplasia in both 

sexes 

Cancer Based on the negative carcinogenic potential of fenamidone in rats and mice, the HIARC classified 

fenamidone as “not likely” to be a human carcinogen by all relevant routes of exposure. 

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

beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no 

observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from 

animal to human (intraspecies). UFH = potential variation in sensitivity among members of the human population (interspecies). 

FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. 

VI. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk 

exceeds 100% of the PAD. The DEEM-FCIDTM 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 (<1 year old), children 1-2, children 3-5, 

children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years. 

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

The estimated exposure (food and water) to the U.S. population from the existing and 

proposed new uses of fenamidone resulted in an estimated risk equivalent to 3% of the 

aPAD at the 95th percentile. The most highly exposed subpopulation was children 1 – 2 

years with an estimated exposure equivalent to 5% of the aPAD at the 95th percentile. 

The results of the acute dietary assessment for all population subgroups are shown in the 

Table 4, below. 

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

The estimated exposure (food and water) to the U.S. population from the existing and 

proposed new uses of fenamidone resulted in an estimated risk equivalent to 52% of the 

coped. The most highly exposed subpopulation was children 1 – 2 years with an 

estimated exposure equivalent to 90% of the cPAD. 

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

below (Table 4). 

Results of Cancer Dietary (Food and Drinking Water) Exposure Analysis

Fenamidone is not likely to be a human carcinogen; therefore a cancer dietary risk 

assessment is not required for this chemical. 
Fenamidone (046679) Dietary Exposure and Risk Assessment D391040 

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

Population Subgroup 

Acute Dietary 

(95th Percentile) Chronic Dietary Cancer 

Dietary 

Exposure 

(mg/kg/day) 

% aPAD* 

Dietary 

Exposure 

(mg/kg/day) 

% cPAD* 

Dietary 

Exposure 

(mg/kg/day) 

Risk 

General U.S. Population 0.041808 3 0.014569 52 N/A N/A 

All Infants (< 1 year old) 0.049304 4 0.021887 77 

N/A N/A 

Children 1-2 years old 0.062898 5 0.025420 90 

Children 3-5 years old 0.057048 5 0.022859 81 

Children 6-12 years old 0.043157 3 0.015630 55 

Youth 13-19 years old 0.035613 3 0.011796 42 

Adults 20-49 years old 0.038559 3 0.013340 47 

Adults 50+ years old 0.041256 3 0.014109 50 

Females 13-49 years old 0.040734 3 0.013388 47 

N/A is “not applicable”. Populations with highest exposure are shown in bold. 

* PAD = population adjusted dose.

VII. Characterization of Inputs/Outputs

The acute and chronic dietary assessments are considered to be conservative, using high 

end field trial data and assuming 100% CT for all commodities, as well as using default 

drying concentration factors. The results of the acute and chronic dietary risk 

assessments are unlikely to underestimate risk. 

VIII. Conclusions

Conservative acute and chronic dietary risk assessments were conducted which used 

maximum field trial residue values, assumed 100 % CT for all commodities and 

incorporated DEEMTM default processing factors for many processed commodities. 

The estimated exposure (food and water) to the U.S. population from the existing and 

proposed new uses of fenamidone resulted in an estimated risk equivalent to 3% of the 

aPAD at the 95th percentile. The most highly exposed subpopulation was children 1 – 2 

years with an estimated exposure equivalent to 5% of the aPAD at the 95th percentile. 

The estimated exposure (food and water) to the U.S. population from the existing and 

proposed new uses of fenamidone resulted in an estimated risk equivalent to 52% of the 
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cPAD. The most highly exposed subpopulation was children 1 – 2 years with an 

estimated exposure equivalent to 90% of the cPAD. 

Acute and chronic dietary risks from the existing and newly proposed used of 

fenamidone are not of concern. 

IX. List of Attachments 

Attachment 1. Acute and Chronic Food plus Water Residue Input file. 

Attachment 2. Acute Dietary Risk Assessment Results file. 

Attachment 3. Chronic Dietary Risk Assessment Results file. 
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Attachment 1. Fenamidone Acute and Chronic Food plus Water Residue Input File 

U.S. Environmental Protection Agency Ver. 2.00 

DEEM-FCID Chronic analysis for FENAMIDONE 1994-98 data 

Residue file: C:\Documents and Settings\ALEMAY\My Documents\Fenamidone- group 

15 and 16\Dietary\DEEM files\fenamidone acute and chronic f_w032311.R98 

 Adjust. #2 NOT used 

Analysis Date 03-23-2011 Residue file dated: 03-23-2011/10:30:44/8 

Reference dose (RfD) = 0.0283 mg/kg bw/day 

Comment:100x uncertainty factor for acute and chronic; 1x FQPA safety factor 

for acute and chronic 

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

- 

Food Crop Residue Adj.Factors 

Comment 

EPA Code Grp Food Name (ppm) 

 #1 #2 

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

------- 

04010050 4A Amaranth, leafy 32.550000 1.000 1.000 

01030150 1CD Arrowroot, flour 0.080000 1.000 1.000 

01030151 1CD Arrowroot, flour-babyfood 0.080000 1.000 1.000 

01030170 1CD Artichoke, Jerusalem 0.080000 1.000 1.000 

04010180 4A Arugula 32.550000 1.000 1.000 

09020210 9B Balsam pear 0.158000 1.000 1.000 

15000250 15 Barley, pearled barley 0.594000 1.000 1.000 

15000251 15 Barley, pearled barley-babyfood 0.594000 1.000 1.000 

15000260 15 Barley, flour 0.594000 1.000 1.000 

15000261 15 Barley, flour-babyfood 0.594000 1.000 1.000 

15000270 15 Barley, bran 0.594000 1.000 1.000 

21000440 M Beef, meat 0.150000 1.000 1.000 

21000441 M Beef, meat-babyfood 0.150000 1.000 1.000 

21000450 M Beef, meat, dried 0.150000 1.920 1.000 

21000460 M Beef, meat byproducts 0.150000 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.150000 1.000 1.000 

21000470 M Beef, fat 0.150000 1.000 1.000 

21000471 M Beef,fat-babyfood 0.150000 1.000 1.000 

21000480 M Beef, kidney 0.150000 1.000 1.000 

21000490 M Beef, liver 0.150000 1.000 1.000 

21000491 M Beef, liver-babyfood 0.150000 1.000 1.000 

01010500 1AB Beet, garden, roots 0.180000 1.000 1.000 

01010501 1AB Beet, garden, roots-babyfood 0.180000 1.000 1.000 

05010610 5A Broccoli 3.270000 1.000 1.000 

05010611 5A Broccoli-babyfood 3.270000 1.000 1.000 

05010620 5A Broccoli, Chinese 3.270000 1.000 1.000 

05020630 5B Broccoli raab 32.990000 1.000 1.000 

05010640 5A Brussels sprouts 0.740000 1.000 1.000 

15000650 15 Buckwheat 0.594000 1.000 1.000 

15000660 15 Buckwheat, flour 0.594000 1.000 1.000 

01010670 1AB Burdock 0.180000 1.000 1.000 

05010690 5A Cabbage 0.740000 1.000 1.000 

05020700 5B Cabbage, Chinese, bok choy 32.990000 1.000 1.000 

05010710 5A Cabbage, Chinese, napa 0.740000 1.000 1.000 

05010720 5A Cabbage, Chinese, mustard 3.270000 1.000 1.000 

09010750 9A Cantaloupe 0.158000 1.000 1.000 

04020760 4B Cardoon 20.160000 1.000 1.000 

01010780 1AB Carrot 0.180000 1.000 1.000 

01010781 1AB Carrot-babyfood 0.180000 1.000 1.000 

01010790 1AB Carrot, juice 0.180000 1.000 1.000 

09010800 9A Casaba 0.158000 1.000 1.000 

01030820 1CD Cassava 0.080000 1.000 1.000 

01030821 1CD Cassava-babyfood 0.080000 1.000 1.000 
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05010830 5A Cauliflower 3.270000 1.000 1.000 

01010840 1AB Celeriac 0.180000 1.000 1.000 

04020850 4B Celery 20.160000 1.000 1.000 

04020851 4B Celery-babyfood 20.160000 1.000 1.000 

04020860 4B Celery, juice 20.160000 1.000 1.000 

04020870 4B Celtuce 20.160000 1.000 1.000 

09020880 9B Chayote, fruit 0.158000 1.000 1.000 

01011000 1AB Chicory, roots 0.180000 1.000 1.000 

09021020 9B Chinese waxgourd 0.158000 1.000 1.000 

04011040 4A Chrysanthemum, garland 32.550000 1.000 1.000 

05021170 5B Collards 32.990000 1.000 1.000 

15001200 15 Corn, field, flour 0.218000 1.000 1.000 

15001201 15 Corn, field, flour-babyfood 0.218000 1.000 1.000 

15001210 15 Corn, field, meal 0.218000 1.000 1.000 

15001211 15 Corn, field, meal-babyfood 0.218000 1.000 1.000 

15001220 15 Corn, field, bran 0.218000 1.000 1.000 

15001230 15 Corn, field, starch 0.218000 1.000 1.000 

15001231 15 Corn, field, starch-babyfood 0.218000 1.000 1.000 

15001240 15 Corn, field, syrup 0.218000 1.000 1.000 

15001241 15 Corn, field, syrup-babyfood 0.218000 1.000 1.000 

15001250 15 Corn, field, oil 0.218000 1.000 1.000 

15001251 15 Corn, field, oil-babyfood 0.218000 1.000 1.000 

15001260 15 Corn, pop 0.594000 1.000 1.000 

15001270 15 Corn, sweet 0.218000 1.000 1.000 

15001271 15 Corn, sweet-babyfood 0.218000 1.000 1.000 

95001280 O Cottonseed, oil 0.080000 1.000 1.000 

95001281 O Cottonseed, oil-babyfood 0.080000 1.000 1.000 

04011330 4A Cress, garden 32.550000 1.000 1.000 

04011340 4A Cress, upland 32.550000 1.000 1.000 

09021350 9B Cucumber 0.158000 1.000 1.000 

04011380 4A Dandelion, leaves 32.550000 1.000 1.000 

01031390 1CD Dasheen, corm 0.080000 1.000 1.000 

08001480 8 Eggplant 0.260000 1.000 1.000 

04011500 4A Endive 32.550000 1.000 1.000 

04021520 4B Fennel, Florence 20.160000 1.000 1.000 

03001640 3 Garlic 0.186000 1.000 1.000 

03001650 3 Garlic, dried 0.186000 1.000 1.000 

03001651 3 Garlic, dried-babyfood 0.186000 1.000 1.000 

01031660 1CD Ginger 0.080000 1.000 1.000 

01031661 1CD Ginger-babyfood 0.080000 1.000 1.000 

01031670 1CD Ginger, dried 0.080000 1.000 1.000 

01011680 1AB Ginseng, dried 0.180000 1.000 1.000 

23001690 M Goat, meat 0.150000 1.000 1.000 

23001700 M Goat, meat byproducts 0.150000 1.000 1.000 

23001710 M Goat, fat 0.150000 1.000 1.000 

23001720 M Goat, kidney 0.150000 1.000 1.000 

23001730 M Goat, liver 0.150000 1.000 1.000 

95001750 O Grape 0.896000 1.000 1.000 

95001760 O Grape, juice 0.896000 1.000 1.000 

95001761 O Grape, juice-babyfood 0.896000 1.000 1.000 

95001770 O Grape, leaves 0.896000 1.000 1.000 

95001780 O Grape, raisin 0.896000 4.300 1.000 

95001790 O Grape, wine and sherry 0.896000 1.000 1.000 

09011870 9A Honeydew melon 0.158000 1.000 1.000 

24001890 M Horse, meat 0.150000 1.000 1.000 

01011900 1AB Horseradish 0.180000 1.000 1.000 

05021940 5B Kale 32.990000 1.000 1.000 

05011960 5A Kohlrabi 0.740000 1.000 1.000 

03001980 3 Leek 1.234000 1.000 1.000 

04012040 4A Lettuce, head 11.790000 1.000 1.000 

04012050 4A Lettuce, leaf 17.580000 1.000 1.000 

28002210 M Meat, game 0.150000 1.000 1.000 

27002220 D Milk, fat 0.030000 1.000 1.000 
Fenamidone (046679) Dietary Exposure and Risk Assessment D391040 

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27002221 D Milk, fat - baby food/infant for 0.030000 1.000 1.000 

27012230 D Milk, nonfat solids 0.030000 1.000 1.000 

27012231 D Milk, nonfat solids-baby food/in 0.030000 1.000 1.000 

27022240 D Milk, water 0.030000 1.000 1.000 

27022241 D Milk, water-babyfood/infant form 0.030000 1.000 1.000 

27032251 D Milk, sugar (lactose)-baby food/ 0.030000 1.000 1.000 

15002260 15 Millet, grain 0.594000 1.000 1.000 

05022290 5B Mustard greens 32.990000 1.000 1.000 

15002310 15 Oat, bran 0.594000 1.000 1.000 

15002320 15 Oat, flour 0.594000 1.000 1.000 

15002321 15 Oat, flour-babyfood 0.594000 1.000 1.000 

15002330 15 Oat, groats/rolled oats 0.594000 1.000 1.000 

15002331 15 Oat, groats/rolled oats-babyfood 0.594000 1.000 1.000 

08002340 8 Okra 1.780000 1.000 1.000 

03002370 3 Onion, dry bulb 0.186000 1.000 1.000 

03002371 3 Onion, dry bulb-babyfood 0.186000 1.000 1.000 

03002380 3 Onion, dry bulb, dried 0.186000 9.000 1.000 

03002381 3 Onion, dry bulb, dried-babyfood 0.186000 9.000 1.000 

03002390 3 Onion, green 1.234000 1.000 1.000 

04012480 4A Parsley, leaves 32.550000 1.000 1.000 

01012500 1AB Parsley, turnip rooted 0.180000 1.000 1.000 

01012510 1AB Parsnip 0.180000 1.000 1.000 

01012511 1AB Parsnip-babyfood 0.180000 1.000 1.000 

08002700 8 Pepper, bell 0.260000 1.000 1.000 

08002701 8 Pepper, bell-babyfood 0.260000 1.000 1.000 

08002710 8 Pepper, bell, dried 0.260000 1.000 1.000 

08002711 8 Pepper, bell, dried-babyfood 0.260000 1.000 1.000 

08002720 8 Pepper, nonbell 1.780000 1.000 1.000 

08002721 8 Pepper, nonbell-babyfood 1.780000 1.000 1.000 

08002730 8 Pepper, nonbell, dried 1.780000 1.000 1.000 

01032960 1C Potato, chips 0.080000 1.000 1.000 

01032970 1C Potato, dry (granules/ flakes) 0.104000 1.000 1.000 

01032971 1C Potato, dry (granules/ flakes)-b 0.104000 1.000 1.000 

01032980 1C Potato, flour 0.104000 1.000 1.000 

01032981 1C Potato, flour-babyfood 0.104000 1.000 1.000 

01032990 1C Potato, tuber, w/peel 0.080000 1.000 1.000 

01032991 1C Potato, tuber, w/peel-babyfood 0.080000 1.000 1.000 

01033000 1C Potato, tuber, w/o peel 0.080000 1.000 1.000 

01033001 1C Potato, tuber, w/o peel-babyfood 0.080000 1.000 1.000 

09023080 9B Pumpkin 0.158000 1.000 1.000 

09023090 9B Pumpkin, seed 0.158000 1.000 1.000 

29003120 M Rabbit, meat 0.150000 1.000 1.000 

04013130 4A Radicchio 11.790000 1.000 1.000 

01013140 1AB Radish, roots 0.180000 1.000 1.000 

01013160 1AB Radish, Oriental, roots 0.180000 1.000 1.000 

05023180 5B Rape greens 32.990000 1.000 1.000 

04023220 4B Rhubarb 20.160000 1.000 1.000 

01013270 1AB Rutabaga 0.180000 1.000 1.000 

15003280 15 Rye, grain 0.594000 1.000 1.000 

15003290 15 Rye, flour 0.594000 1.000 1.000 

01013310 1AB Salsify, roots 0.180000 1.000 1.000 

03003380 3 Shallot 0.186000 1.000 1.000 

26003390 M Sheep, meat 0.150000 1.000 1.000 

26003391 M Sheep, meat-babyfood 0.150000 1.000 1.000 

26003400 M Sheep, meat byproducts 0.150000 1.000 1.000 

26003410 M Sheep, fat 0.150000 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.150000 1.000 1.000 

26003420 M Sheep, kidney 0.150000 1.000 1.000 

26003430 M Sheep, liver 0.150000 1.000 1.000 

15003440 15 Sorghum, grain 0.594000 1.000 1.000 

15003450 15 Sorghum, syrup 0.594000 1.000 1.000 

06003470 6 Soybean, seed 0.232000 1.000 1.000 

06003480 6 Soybean, flour 0.232000 1.000 1.000 
Fenamidone (046679) Dietary Exposure and Risk Assessment D391040 

Page 13 of 15

06003481 6 Soybean, flour-babyfood 0.232000 1.000 1.000 

06003490 6 Soybean, soy milk 0.232000 1.000 1.000 

06003491 6 Soybean, soy milk-babyfood or in 0.232000 1.000 1.000 

06003500 6 Soybean, oil 0.232000 1.000 1.000 

06003501 6 Soybean, oil-babyfood 0.232000 1.000 1.000 

04013550 4A Spinach 32.550000 1.000 1.000 

04013551 4A Spinach-babyfood 32.550000 1.000 1.000 

09023560 9B Squash, summer 0.158000 1.000 1.000 

09023561 9B Squash, summer-babyfood 0.158000 1.000 1.000 

09023570 9B Squash, winter 0.158000 1.000 1.000 

09023571 9B Squash, winter-babyfood 0.158000 1.000 1.000 

95003590 O Strawberry 0.252000 1.000 1.000 

95003591 O Strawberry-babyfood 0.252000 1.000 1.000 

95003600 O Strawberry, juice 0.252000 1.000 1.000 

95003601 O Strawberry, juice-babyfood 0.252000 1.000 1.000 

20003640 20 Sunflower, seed 0.080000 1.000 1.000 

20003650 20 Sunflower, oil 0.080000 1.000 1.000 

20003651 20 Sunflower, oil-babyfood 0.080000 1.000 1.000 

01033660 1CD Sweet potato 0.080000 1.000 1.000 

01033661 1CD Sweet potato-babyfood 0.080000 1.000 1.000 

04023670 4B Swiss chard 20.160000 1.000 1.000 

01033710 1CD Tanier, corm 0.080000 1.000 1.000 

08003740 8 Tomatillo 0.860000 1.000 1.000 

08003750 8 Tomato 0.860000 1.000 1.000 

08003751 8 Tomato-babyfood 0.860000 1.000 1.000 

08003760 8 Tomato, paste 2.880000 1.000 1.000 

08003761 8 Tomato, paste-babyfood 2.880000 1.000 1.000 

08003770 8 Tomato, puree 1.779000 1.000 1.000 

08003771 8 Tomato, puree-babyfood 1.779000 1.000 1.000 

08003780 8 Tomato, dried 0.860000 14.300 1.000 

08003781 8 Tomato, dried-babyfood 0.860000 14.300 1.000 

08003790 8 Tomato, juice 0.860000 1.500 1.000 

15003810 15 Triticale, flour 0.594000 1.000 1.000 

15003811 15 Triticale, flour-babyfood 0.594000 1.000 1.000 

01033870 1CD Turmeric 0.080000 1.000 1.000 

01013880 1AB Turnip, roots 0.180000 1.000 1.000 

05023890 5B Turnip, greens 32.990000 1.000 1.000 

86010000 O Water, direct, all sources 0.178000 1.000 1.000 

86020000 O Water, indirect, all sources 0.178000 1.000 1.000 

09013990 9A Watermelon 0.158000 1.000 1.000 

09014000 9A Watermelon, juice 0.158000 1.000 1.000 

15004010 15 Wheat, grain 0.594000 1.000 1.000 

15004011 15 Wheat, grain-babyfood 0.594000 1.000 1.000 

15004020 15 Wheat, flour 0.594000 1.000 1.000 

15004021 15 Wheat, flour-babyfood 0.594000 1.000 1.000 

15004030 15 Wheat, germ 0.594000 1.000 1.000 

15004040 15 Wheat, bran 0.594000 1.000 1.000 

01034060 1CD Yam, true 0.080000 1.000 1.000 

01034070 1CD Yam bean 0.080000 1.000 1.000 
Fenamidone (046679) Dietary Exposure and Risk Assessment D391040 

Page 14 of 15

Attachment 2. Fenamidone Acute Dietary Risk Assessment Results File 

U.S. Environmental Protection Agency Ver. 2.02 

DEEM-FCID ACUTE Analysis for FENAMIDONE (1994-98 data) 

Residue file: fenamidone acute and chronic f_w041311.R98 

Adjustment factor #2 NOT used. 

Analysis Date: 04-13-2011/09:47:04 Residue file dated: 04-13-2011/09:41:07/8 

NOEL (Acute) = 125.000000 mg/kg body-wt/day 

Daily totals for food and foodform consumption used. 

Run Comment: "100x uncertainty factor for acute and chronic; 1x FQPA safety f 

actor for acute and chronic" 

=============================================================================== 

Summary calculations (per capita): 

 95th Percentile 99th Percentile 99.9th Percentile 

 Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

U.S. Population: 

 0.041808 3.34 2989 0.088483 7.08 1412 0.208933 16.71 598 

All infants: 

 0.049304 3.94 2535 0.227071 18.17 550 0.622430 49.79 200 

Children 1-2 yrs: 

 0.062898 5.03 1987 0.155734 12.46 802 0.488435 39.07 255 

Children 3-5 yrs: 

 0.057048 4.56 2191 0.132124 10.57 946 0.435711 34.86 286 

Children 6-12 yrs: 

 0.043157 3.45 2896 0.083366 6.67 1499 0.197116 15.77 634 

Youth 13-19 yrs: 

 0.035613 2.85 3509 0.073164 5.85 1708 0.138845 11.11 900 

Adults 20-49 yrs: 

 0.038559 3.08 3241 0.077554 6.20 1611 0.161755 12.94 772 

Adults 50+ yrs: 

 0.041256 3.30 3029 0.094922 7.59 1316 0.176801 14.14 707 

Females 13-49 yrs: 

 0.040734 3.26 3068 0.076527 6.12 1633 0.202195 16.18 618 

 

 
Fenamidone (046679) Dietary Exposure and Risk Assessment D391040 

Page 15 of 15

Attachment 3. Fenamidone Chronic Dietary Risk Assessment Results File 

U.S. Environmental Protection Agency Ver. 2.00 

DEEM-FCID Chronic analysis for FENAMIDONE (1994-98 data) 

Residue file name: C:\Documents and Settings\ALEMAY\My Documents\Fenamidone- group 15 and 

16\Dietary\DEEM files\fenamidone acute and chronic f_w041311.R98 

 Adjustment factor #2 NOT used. 

Analysis Date 04-13-2011/09:42:22 Residue file dated: 04-13-2011/09:41:07/8 

Reference dose (RfD, Chronic) = .0283 mg/kg bw/day 

COMMENT 1: 100x uncertainty factor for acute and chronic; 1x FQPA safety factor for acute 

and chronic 

=============================================================================== 

 Total exposure by population subgroup 

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

 Total Exposure 

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

U.S. Population (total) 0.014569 51.5% 

U.S. Population (spring season) 0.014640 51.7% 

U.S. Population (summer season) 0.014421 51.0% 

U.S. Population (autumn season) 0.014606 51.6% 

U.S. Population (winter season) 0.014614 51.6% 

Northeast region 0.014861 52.5% 

Midwest region 0.014102 49.8% 

Southern region 0.013743 48.6% 

Western region 0.016119 57.0% 

Hispanics 0.014357 50.7% 

Non-hispanic whites 0.013945 49.3% 

Non-hispanic blacks 0.016158 57.1% 

Non-hisp/non-white/non-black 0.020812 73.5% 

All infants (< 1 year) 0.021887 77.3% 

Nursing infants 0.008474 29.9% 

Non-nursing infants 0.026978 95.3% 

Children 1-6 yrs 0.023098 81.6% 

Children 7-12 yrs 0.014995 53.0% 

Females 13-19 (not preg or nursing) 0.011140 39.4% 

Females 20+ (not preg or nursing) 0.014253 50.4% 

Females 13-50 yrs 0.013595 48.0% 

Females 13+ (preg/not nursing) 0.011659 41.2% 

Females 13+ (nursing) 0.015440 54.6% 

Males 13-19 yrs 0.012373 43.7% 

Males 20+ yrs 0.012969 45.8% 

Seniors 55+ 0.014053 49.7% 

Children 1-2 yrs 0.025420 89.8% 

Children 3-5 yrs 0.022859 80.8% 

Children 6-12 yrs 0.015630 55.2% 

Youth 13-19 yrs 0.011796 41.7% 

Adults 20-49 yrs 0.013340 47.1% 

Adults 50+ yrs 0.014109 49.9% 

Females 13-49 yrs 0.013388 47.3% 

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