Document ID: EPA-HQ-OPP-2008-0458-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-07-15T04:00Z

0.17  SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	February 23, 2009 

SUBJECT:	Fenamidone – Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessments for Section 3 Registration
Actions to Add New Uses on the Root Vegetable Subgroup 1B (except
radish), Okra, Turnip Greens, Cilantro Leaves, Grapes Grown East of the
Rocky Mountains and Rotational Crop Uses for Field Corn, Sweet Corn and
Soybeans.

PC Code:  046679	DP Barcode:  D362172

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

Petition No.:  7E7350, 8F7410	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:	Donna S. Davis, Chemist

RAB VII/Health Effects Division (7509P)

THROUGH:	David E. Hrdy, Senior Biologist

Debra Rate, Ph.D., Biologist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

Michael S. Metzger, Chief

RAB VII/Health Effects Division (7509P)

To:		Susan Stanton

		Barbara Madden, Minor Use Team Leader

		Daniel Rosenblatt, Chief

		Integration Minor Use and Emergency Response Branch

		Registration Division (7505P) 

		Rosemary Kearns

		Tony Kish, PM 22

		Cynthia Giles-Parker, Chief

		Fungicide Branch

		Registration Division (7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure
and risk assessments were conducted using the Dietary Exposure
Evaluation Model DEEM-FCID™, 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 Section 3 requests to add new uses on
the root vegetable subgroup 1B (except radish), okra, turnip greens,
cilantro leaves, grapes grown east of the Rocky Mountains and rotational
crop uses on field corn, sweet corn and soybeans. 

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 DEEM™ 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.

 incorporated DEEM™ 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 51% of the chronic population adjusted dose (cPAD). 
The most highly exposed subpopulation was children 1 – 2 years with an
estimated exposure equivalent to 88% 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 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:      HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf" 
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
Tom Bloem (D336201, 6/14/07).

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, carrot, sunflower, tomato and grapes ranging from 0.02 ppm
to 55 ppm.  Animal commodity tolerances are established for residues of
fenamidone and RPA 717879 (DADK-Fen) ranging from 0.01 ppm in milk to
0.10 ppm in ruminant fat, meat and meat byproducts under 180.579(a)(2). 
Rotational crop tolerances are established for resides of fenamidone and
RPA 717870 (DADK-Fen) in wheat 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)

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.  Residue values for plant commodities are based on maximum
field trial values.  For animal commodities, LOQ residues were assumed
as detailed in the T. Bloem memorandum of dated 7/14/07 (D336201).  HED
notes that no new residue data were submitted to support the new primary
crop uses on the root vegetable subgroup 1B (except radish), okra,
turnip greens, cilantro leaves or grapes grown east of the Rockies. 
These tolerances are being established based on translation from
existing tolerances.  Residue values in this assessment for those new
uses were also translated from maximum field trial data from existing
uses.  Rotational crop tolerances were established based on maximum
residues in rotational crop field trials.  However, HED notes that the
analytical method used to detect residues of fenamidone was not
validated for detection of DA-Fen conjugate; therefore, HED has reviewed
available confined rotational crop data and has established a ratio
between residues of DADK-Fen and the DA-Fen conjugate.  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 residue of concern
in rotational crops.  Details of the new residue values included in the
acute and chronic dietary risk assessment 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( (ver. 7.81) 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

Crop Subgroup 1B (root vegetables except sugar beets), excluding
radishes which includes:

esidues of fenamidone from the carrot field trials were ≤0.11 ppm
(D314318, T. Bloem, 7-Jun-2007), however the analytical method did not
recover residues of RPA 413255, which is also a residue of concern in
plants.  The carrot metabolism study (469291101.der.doc) indicated that
residues of RPA 413255 were 0.6x that of fenamidone; therefore, the
maximum combined residues of fenamidone and RPA 413255 were estimated to
be 0.18 ppm (0.11 + 0.11 x 0.6 = 0.18)

Okra	1.78	Translated from non bell pepper data.  Maximum combined
residue of fenamidone, RPA 717879, RPA 405862, and RPA 408056 from the
non bell pepper (D314318, T. Bloem, 7-Jun-2007) field trials.

Cilantro Leaves	32.55	Translated from spinach, the commodity with the
highest residues for which data were used to establish a leafy
vegetables (except brassica) crop group tolerance.  Maximum combined
residue of fenamidone, RPA 717879, RPA 405862, and RPA 408056 from
spinach (D314318, T. Bloem, 7-Jun-2007) field trials.

Grapes – Domestic, grown east of the Rocky Mountains only, Grape Juice
and Wine	0.896	Translated domestic residues from import use data per
Chem SAC guidance (D352806, D. Davis, 12/18/08).  Maximum combined
fenamidone and RPA 405862 residues from grape field trials; only
residues of fenamidone and RPA 405862 were monitored in the grape field
trial and processing studies; the submitted grape metabolism study
indicated that residues of RPA 408056 and RPA 717879 are insignificant
in grape; therefore, the dietary-exposure assessment included only
residues of fenamidone and RPA 405862 for grape, grape juice, and wine
(fenamidone and RPA 408056 comprised 73% of the TRR in grape);
processing study indicated that the combined residues of fenamidone and
RPA 408056 do not concentrate in grape juice or wine (D297216, T. Bloem,
25-May-2004).

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).

Soybean seed and processed commodities	0.232	Maximum rotational crop
soybean seed 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 9.6x residues of RPA
717879 from the highest confined rotational crop study (turnips).  Total
residue of concern for soybean seed and processed commodities  is
calculated as 0.02 ppm (fenamidone) + 0.02 ppm (RPA 717879 and free RPA
405862) + 0.02 x 9.6 (ratio to yield conjugated RPA 405862) = 0.232
(D357372, A. LaMay, 2/24/09).

 

 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 total fenamidone residues, which
includes parent and its degradation products, RPA-412636, RPA-412108,
RPA-411639, RPA-413255, RPA-409446, RPA- 410995.  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:   HYPERLINK
"http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .

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
176 μg/L.  

For both the acute and chronic dietary analysis, HED will use the
maximum surface water EDWC of 176 μg/L, since it is the highest EDWC
reported for fenamidone.

IV.	DEEM-FCID™ 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-FCID™, 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 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 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 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

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-FCID™ analyses
estimate the dietary exposure of the U.S. population and various
population subgroups.  The results reported in Tables 4 and 5 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 51% of the coped.  The most highly exposed
subpopulation was children 1 – 2 years with an estimated exposure
equivalent to 88% 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.  

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	0.041604	3	0.014373	51	N/A	N/A

All Infants (< 1 year old)	0.048649	4	0.021424	76	N/A	N/A

Children 1-2 years old	0.062413	5	0.024944	88

Children 3-5 years old	0.056283	4	0.022475	79

Children 6-12 years old	0.042732	3	0.015420	54

Youth 13-19 years old	0.035419	3	0.011678	41

Adults 20-49 years old	0.038239	3	0.013151	46

Adults 50+ years old	0.040975	3	0.013959	49

Females 13-49 years old	0.040306	3	0.013261	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 DEEM™ 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 51% of the cPAD.  The most highly exposed
subpopulation was children 1 – 2 years with an estimated exposure
equivalent to 88% 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.

cc:	Donna Davis

Attachment 1.  Fenamidone Acute and Chronic Food plus Water Residue
Input File 

U.S. Environmental Protection Agency                                
Ver. 2.02

DEEM-FCID Acute analysis for FENAMIDONE

Residue file name: C:\Documents and Settings\ddavis05\DEEM
files\Fenamidone\fenamidone acute and chronic f_w.R98

Analysis Date 02-23-2009             Residue file dated:
02-23-2009/08:15:29/8

Reference dose: aRfD = 1.25 mg/kg bw/day  NOEL = 125 mg/kg bw/day

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

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  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

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

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

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

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

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

05022290 5B   Mustard greens                    32.990000   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

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

06003470 6    Soybean, seed                      0.232000   1.000  1.000

06003480 6    Soybean, flour                     0.232000   1.000  1.000

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

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         0.176000   1.000  1.000

86020000 O    Water, indirect, all sources       0.176000   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

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_w.R98

Adjustment factor #2 NOT used.

Analysis Date: 02-23-2009/08:22:41    Residue file dated:
02-23-2009/08:15:29/8

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

Daily totals for food and foodform consumption used.

Run Comment: "100x uncertainity 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:

  0.041604    3.33    3004    0.088422    7.07    1413    0.208123  
16.65     600  

All infants:

  0.048649    3.89    2569    0.222857   17.83     560    0.623156  
49.85     200  

Children 1-2 yrs:

  0.062413    4.99    2002    0.154679   12.37     808    0.488983  
39.12     255  

Children 3-5 yrs:

  0.056283    4.50    2220    0.131594   10.53     949    0.433199  
34.66     288  

Children 6-12 yrs:

  0.042732    3.42    2925    0.083066    6.65    1504    0.196404  
15.71     636  

Youth 13-19 yrs:

  0.035419    2.83    3529    0.073007    5.84    1712    0.138831  
11.11     900  

Adults 20-49 yrs:

  0.038239    3.06    3268    0.076963    6.16    1624    0.161061  
12.88     776  

Adults 50+ yrs:

  0.040975    3.28    3050    0.095005    7.60    1315    0.176666  
14.13     707  

Females 13-49 yrs:

  0.040306    3.22    3101    0.076045    6.08    1643    0.202268  
16.18     617 



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\ddavis05\DEEM
files\Fenamidone\fenamidone acute and chronic f_w.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 02-23-2009/08:23:34     Residue file dated:
02-23-2009/08:15:29/8

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

COMMENT 1: 100x uncertainity 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)                     0.014373               
50.8%

U.S. Population (spring season)             0.014434               
51.0%

U.S. Population (summer season)             0.014222               
50.3%

U.S. Population (autumn season)             0.014417               
50.9%

U.S. Population (winter season)             0.014423               
51.0%

Northeast region                            0.014669               
51.8%

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           0.013894                49.1%

Southern region                             0.013567               
47.9%

Western region                              0.015900               
56.2%

Hispanics                                   0.014175               
50.1%

Non-hispanic whites                         0.013741               
48.6%

Non-hispanic blacks                         0.015986               
56.5%

Non-hisp/non-white/non-black                0.020652               
73.0%

All infants (< 1 year)                      0.021424               
75.7%

Nursing infants                             0.008212               
29.0%

Non-nursing infants                         0.026438               
93.4%

Children 1-6  yrs                           0.022699               
80.2%

Children 7-12 yrs                           0.014799               
52.3%

Females 13-19 (not preg or nursing)         0.011038               
39.0%

Females 20+ (not preg or nursing)           0.014121               
49.9%

Females 13-50 yrs                           0.013457               
47.6%

Females 13+ (preg/not nursing)              0.011560               
40.8%

Females 13+ (nursing)                       0.015299               
54.1%

Males 13-19 yrs                             0.012240               
43.3%

Males 20+ yrs                               0.012747               
45.0%

Seniors 55+                                 0.013910               
49.2%

Children 1-2 yrs                            0.024944               
88.1%

Children 3-5 yrs                            0.022475               
79.4%

Children 6-12 yrs                           0.015420               
54.5%

Youth 13-19 yrs                             0.011678               
41.3%

Adults 20-49 yrs                            0.013151               
46.5%

Adults 50+ yrs                              0.013959               
49.3%

Females 13-49 yrs                           0.013261               
46.9%

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

Fenamidone (046679)	                Dietary Exposure and Risk Assessment
                       D362172

	

Page   PAGE  8  of   NUMPAGES  17 

Page   PAGE  1  of   NUMPAGES  17 

Fenamidone (046679)	                 Dietary Exposure and Risk
Assessment	                       D362172