Document ID: EPA-HQ-OPP-2006-0848-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-10-24T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:  			14-June-2007

Subject:		Fenamidone - Acute and Chronic Dietary-Exposure and Risk
Assessments in Support of Application of Fenamidone to Cotton, Carrot,
Sunflower, Brassica Vegetables (group 5), Leafy (except Brassica)
Vegetables (group 4), Fruiting Vegetables (group 8), and Strawberry
(rotational crop).  

Registration #:	6E7109	DP #:	336201

Decision #:	370420	40 CFR 	180.579

Reviewer/To:	Tom Bloem, Chemist

Registration Action Branch 1/Health Effects Division (RAB1/HED; 7509P)

Through:	Felecia Fort, Chemist

		Dave Soderberg, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

George F. Kramer, Ph.D., Senior Chemist

RAB1/HED (7509P)

Executive Summary

Acute and chronic dietary exposure and risk assessments were conducted
in support of application of fenamidone to cotton, carrot, sunflower,
Brassica vegetables (group 5), leafy (except Brassica) vegetables (group
4), and fruiting vegetables (group 8).  The analyses were conducted
using the Dietary Exposure Evaluation Model - Food Consumption Intake
Database (DEEM-FCID(, ver. 2.03).  DEEM-FCID( incorporates food
consumption data from the United States Department of Agriculture (USDA)
Continuing Surveys of Food Intakes by Individuals (CSFII; 1994-1996 and
1998).  

 ≤LOQ at 3.4x the maximum reasonable dietary burden (MRDB; 3.4x was
the highest level tested; 180.6(a)(3) for hog and poultry).  The acute
and chronic dietary analysis also incorporated the Screening
Concentration in Ground Water (SCI-GROW) estimate resulting from
application of fenamidone to carrots (178 ppb; highest acute/chronic
estimate; 3 x 0.267 lb ai/acre).  The acute dietary exposure estimates
were (5% the acute population adjusted dose (aPAD; 95th %; children 1-2
years old were the most highly exposed population) and the chronic
dietary exposure estimates were (82% the chronic PAD (cPAD; children 1-2
years old were the most highly exposed population) and are therefore not
of concern to HED.  

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 PAD.  The PAD is equivalent
to the reference dose (RfD) divided by the Food Quality Protection Act
(FQPA) Safety Factor.  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,” 6/21/2000, 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 (8/20/99).  The most recent fenamidone dietary risk
assessment was conducted by D. Rate (D331141, 13-Aug-2006).

II.	Residue Information

Residues of Concern in Plants and Livestock:  The HED Metabolism
Assessment Review Committee (MARC) has reviewed potato, tomato, lettuce,
grape, poultry, and ruminant metabolism studies; rotational crop
studies; and environmental fate data (MARC memos - T. Bloem et al.,
11-July-2002; T. Bloem et al., 25-May-2004).  As part of the current
petition, a carrot metabolism study was submitted (46921101.der.doc). 
Based on these data, HED concludes that the residues of concern in
plants, livestock, rotational crops, and water are as specified in Table
1.  HED notes that, due to the concern for potential formation of
aniline(s), these conclusions should not be translated to other crops
(see HED risk assessment D314116, T. Bloem et al., in draft).

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

Matrix	Tolerance Expression	Residues for Risk Assessment

registered/proposed crops excluding carrot1	fenamidone	fenamidone, RPA
408056, RPA 717879, RPA 405862

carrot1	fenamidone	fenamidone, RPA 413255

livestock2	fenamidone, RPA 717879	fenamidone, RPA 717879, RPA 408056

rotational Crops3	fenamidone, RPA 717879	fenamidone, RPA 717879, and RPA
408056 (free and conjugated)

1	these decisions should not be translated to other crops

2	the residues of concern in livestock are based on the
currently-registered/proposed crops; if additional crops are requested
these decisions will be reevaluated

3	storage stability data validating the confined rotational crop study
storage intervals and conditions are necessary

Established/Recommended Tolerances:  Fenamidone is currently registered
for application to lettuce (head and leaf), bulb vegetables, cucurbit
vegetables, tuberous and corm vegetables, tomato, and grape with
tolerances for residues of fenamidone per se ranging from 0.02-20 ppm
(40 CFR 180.579(a)(1)).  Tolerances have been established for the
combined residues of fenamidone and RPA 717879 as a result of secondary
residues in milk (0.01 ppm) and ruminant  fat (0.10 ppm), meat (0.10
ppm), and meat byproducts (0.10 ppm; 40 CFR 180.579(a)(2)) and in wheat
as a result of crop rotation (0.10-0.50 ppm; 40 CFR 180.579(d)).  HED
has reviewed the residue chemistry data associated with the current
petition and is recommending for establishment of the following
tolerances for residues of fenamidone per se (D3143118, T. Bloem,
7-Jun-2007):

Carrot	0.15 ppm

Sunflower	0.02 ppm

Vegetable, brassica, head and stem, subgroup 5a	5.0 ppm

Vegetable, brassica, leafy greens, subgroup 5b	55 ppm

Vegetable fruiting, group 8 (except nonbell pepper)	1.0 ppm

Pepper, nonbell	3.5 ppm

Vegetable, leafy, except brassica, 4	60 ppm

Cotton, gin byproducts	0.02 ppm

Cotton, undelinted seed	0.02 ppm

*Strawberries (rotational crop)	0.02 ppm

*strawberry  are as a result of inadvertent residues in/on a rotated
crop with a tolerance expression of fenamidone and RPA 717879

Residues Used in the Acute/Chronic Risk Assessments:  Since the residues
of concern for tolerance expression and risk assessment are different
for the registered/proposed crops, rotational crops, and livestock
matrices, tolerance-level residues were not assumed.  For plants, the
acute/chronic analyses assumed maximum field trial residues for the
residues of concern for risk assessment and assumed 100% crop treated. 
DEEM( (ver. 7.81) default processing factors were maintained for all
commodities excluding grape juice, dried potato, tomato paste, and
tomato puree; for these commodities, the DEEM( (ver. 7.81) default
processing factors were reduced to 1 based on processing data (grape) or
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, 22-Apr-2004).  For ruminant commodities, LOQ
residues were assumed based on residues of concern ≤LOQ at 3.4x the
maximum reasonable dietary burden (MRDB; 3.4x was the highest level
tested; 180.6(a)(3) for hog and poultry).  Table 2 is a summary of the
residues used in the acute and chronic dietary exposure analyses.  

Table 2:  Summary of Residues Used in the Acute and Chronic Dietary
Exposure Analyses

Crop/Commodity	Residues (ppm)	Comment

Cucurbit Vegetables

Cucurbit vegetable	0.158	maximum combined residue of fenamidone, RPA
717879, RPA 405862, and RPA 408056 from cucurbit vegetable field trials
(D297216, T. Bloem, 25-May-2004); applied to all cucurbit vegetables

Bulb Vegetables

dry bulb onion	0.186	maximum combined residue of fenamidone, RPA 717879,
RPA 405862, and RPA 408056 from dry bulb onion and green onion field
trials (D297216, T. Bloem, 25-May-2004); translated to the remaining
bulb vegetable crops according to HED SOP00_1 (Guidance for Translation
of Field Trial Data from Representative Commodities in the Crop Group
Regulation to Other Commodities in Each Crop Group/Subgroup;
12-Aug-2000)

green onion	1.234

	Fruiting Vegetables

tomato	0.860	maximum combined residue of combined residue of fenamidone,
RPA 717879, RPA 405862, and RPA 408056 from the tomato (D297216, T.
Bloem, 25-May-2004 22), bell pepper (D318318, T. Bloem, -Jun-2007), and
nonbell pepper (D314318, T. Bloem, 7-Jun-2007) field trials; translated
to the remaining fruiting vegetable crops according to HED SOP00_1
(Guidance for Translation of Field Trial Data from Representative
Commodities in the Crop Group Regulation to Other Commodities in Each
Crop Group/Subgroup; 12-Aug-2000)

bell pepper	0.26

	nonbell pepper	1.78

	tomato paste	2.880	tomato HAFT (0.847 ppm) and 3.4x concentration
factor for combined residues of fenamidone, RPA 717879, RPA 405862, and
RPA 408056 ( 0.847 x 3.4 = 2.880); D277818, T. Bloem, 22-Apr-2004

tomato puree	1.779	tomato HAFT ( 0.847 ppm) and 2.1x concentration
factor for combined residues of fenamidone, RPA 717879, RPA 405862, and
RPA 408056 (0.847 x 2.1 = 1.779);  D277818, T. Bloem, 22-Apr-2004

Leafy (except Brassica) Vegetables

lettuce, head	11.79	maximum combined residue of fenamidone, RPA 717879,
RPA 405862, and RPA 408056 from the lettuce (head and leaf; D281887, T.
Bloem, 18-Jul-2002), celery (D314318, T. Bloem, 7-Jun-2007), and spinach
(D314318, T. Bloem, 7-Jun-2007) field trials; translated to the
remaining leafy (except Brassica) vegetable crops according to HED
SOP00_1 (Guidance for Translation of Field Trial Data from
Representative Commodities in the Crop Group Regulation to Other
Commodities in Each Crop Group/Subgroup; 12-Aug-2000)

lettuce, leaf	17.58

	celery	20.16 

	spinach	32.55

	Brassica (Cole) Leafy Vegetables

broccoli	3.27	maximum combined residue of fenamidone, RPA 717879, RPA
405862, and RPA 408056 from the broccoli, cabbage, and mustard green
field trials (D314318, T. Bloem, 7-Jun-2007); translated to the
remaining Brassica leafy vegetable crops according to HED SOP00_1
(Guidance for Translation of Field Trial Data from Representative
Commodities in the Crop Group Regulation to Other Commodities in Each
Crop Group/Subgroup; 12-Aug-2000)

cabbage, heads with wrapper leaves	0.74

	mustard greens	32.99

	Tuberous and Corm Vegetables

potato	0.08	maximum combined residue of fenamidone, RPA 717879, RPA
405862, and RPA 408056 from the potato field trial (D297216, T. Bloem,
25-May-2004); translated to the remaining tuberous and corm vegetable
crops according to HED SOP00_1 (Guidance for Translation of Field Trial
Data from Representative Commodities in the Crop Group Regulation to
Other Commodities in Each Crop Group/Subgroup; 12-Aug-2000)

potato, dry	0.104	potato HAFT (0.08 ppm) and 1.3x dry potato
concentration factor for the combined residues of fenamidone, RPA
717879, RPA 405862, and RPA 408056 (0.08 x 1.3 = 0.104); D297216, T.
Bloem, 25-May-2004

grape juice and wine	0.896	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 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

cottonseed oil	0.08	combined residues of fenamidone, RPA 717879, RPA
405862, and RPA 408056 <0.08 ppm (<LOQ) in/on cottonseed and sunflower
seed following treatment at 5x the proposed rate (D314318, T. Bloem,
7-Jun-2007)

sunflower seed oil	0.08

	carrot root	0.18	residues of fenamidone from the carrot field trials
were ≤0.11 ppm (D314318, T. Bloem, 7-Jun-2007); 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)

wheat, grain	0.594	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)

strawberry	0.252	the strawberry field rotational crop study monitored
for residues of fenamidone, RPA 717879, and free RPA 408056 (highest and
average combined residues in strawberry of <0.06; 46440805.der.doc);
residues of conjugated RPA 408056 were estimated in strawberry using the
maximum conjugated RPA 408056:RPA 717879 residue ratio for from the
confined rotational crop study (9.6x; 30-day turnip top; D281887, T.
Bloem, 18-Jul-2002) and the RPA 717879 from the strawberry field
rotational crop study (residues <0.02 ppm; 0.06 + 0.02 x 9.6 = 0.252) 

ruminant meat and meat byproducts	0.15	ruminant feeding study - residues
of fenamidone, RPA 717879, and RPA 408056 were <LOQ in meat, fat, liver,
and kidney when dosed at 3.4x the MRDB (D314318, T. Bloem, 7-Jun-2007);
therefore , LOQ fenamidone, RPA 717879, and RPA 408056 residues were
assumed (tissue LOQ = 0.05 ppm)

milk	0.03	ruminant feeding study - residues of fenamidone, RPA 717879,
and RPA 408056 were (LOQ in milk samples following dosing at 3.4x the
MRDB (D314318, T. Bloem, 7-Jun-2007); therefore , LOQ fenamidone, RPA
717879, and RPA 408056 residues were assumed (milk LOQ = 0.01 ppm);
feeding study did not demonstrate a concentration of residues in fat

III.  Water Data

Drinking water residues were incorporated directly into the acute and
chronic dietary analyses (“water, direct, all sources” and “water,
indirect, all sources”) and were provided by the Environmental Fate
and Effects Division (EFED; D332878, J. Hetrick, 14-May-2007).  EFED
generated the surface water and ground water estimates using the
Pesticide Root Zone Model  SEQ CHAPTER \h \r 1 /Exposure Analysis
Modeling System (PRZM/EXAMS)  SEQ CHAPTER \h \r 1  and SCI-GROW (Tier 1)
models, respectively.  Table 3 is a summary of the modeled water
concentrations.  Based on these estimates, the acute and chronic
analyses assumed a water residue estimate of 178 ppb.  

Table 3:  Estimated Drinking Water Concentrations for Fenamidone (ppb)

	Acute	Chronic	Long-term average

Surface1	41.66	11.88	5.99

Ground2	178	178	178

1	acute estimate based on application to peppers in FL (single/seasonal
rates of 0.267/0.80 lb ai/acre; RTI = 5 days) and the chronic and long
term estimates based on application to lettuce in CA  (single/seasonal
rates of 0.267/0.80 lb ai/acre; RTI = 5 days); the default 0.87 PCA was
assumed for both

2	SCI-GROW estimate assuming a single/seasonal rate of 0.267/0.80 lb
ai/acre; RTI = 5 days

IV.  Program and Consumption Information

Fenamidone acute and chronic dietary exposure assessments were conducted
using DEEM-FCID( (Ver. 2.03), which incorporates consumption data from
USDA’s 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).  HED requested a developmental
neurotoxicity study and concluded that a 10x database uncertainty factor
should be applied to all dietary exposure assessments pending the
submission of this study.  The petitioner has submitted the requested
study; based on a review of these data, HED determined that the
previously established 10x database uncertainty factor may be reduced to
1x (see HED risk assessment D314116, T. Bloem et al., in draft).  Based
on toxicological considerations and the residue assumptions used in the
dietary analyses, HED concludes that the FQPA Safety Factor should be
reduced to 1x when assessing acute and chronic dietary exposures.  Table
4 summarizes the endpoints used for dietary exposure assessment.   

Table 4:  Summary of Toxicological Dose and Endpoints for Fenamidone
Dietary Exposure Assessment

Exposure

Scenario	Dose Used in Risk

Assessment, UF 	FQPA SF* LOC for Risk Assessment	Study and Toxicological
Effects

Acute Dietary -

all populations	NOAEL = 125

UF = 100

Acute RfD = 1.25 mg/kg/day	FQPA SF = 1x

aPAD = 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

UF = 100

chronic RfD = 0.028 mg/kg/day	FQPA SF= 1

cPAD = 0.028 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.

UF = uncertainty factor (10x for interspecies variation and 10x for
intraspecies variation); NOAEL = no observable adverse effect level;
LOAEL = lowest observable adverse effect level; LOC = level of concern

VI.	Results/Discussion

Acute and Chronic analyses were performed using DEEM-FCID( (ver. 2.03).
DEEM-FCID( (ver. 2.03) estimates the dietary exposure of the U.S.
population and various population subgroups.  The results reported 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.  The acute dietary exposure estimates were
(5% aPAD (95th%; children 1-2 years old were the most highly exposed
population) and the chronic dietary exposure estimates were (82% cPAD
(children 1-2 years old were the most highly exposed population) and are
therefore not of concern to HED.  Tables 5 an 6 are summaries of the
acute and chronic exposure estimates.  



Table 5:  Summary of Acute Dietary Exposure

Population Subgroup	aPAD (mg/kg/day)	Acute (95th percentile)

Exposure (mg/kg/day)	%aPAD

General U.S. Population	1.25	0.040621	3

All Infants (< 1 year old)

0.047689	4

Children 1-2 years old

0.059961	5

Children 3-5 years old

0.053302	4

Children 6-12 years old

0.041143	3

Youth 13-19 years old

0.034314	3

Adults 20-49 years old

0.037755	3

Adults 50+ years old

0.040498	3

Females 13-49 years old

0.039529	3

Table 6:  Summary of Chronic Dietary Exposure

Population Subgroup	cPAD (mg/kg/day)	Chronic

Exposure (mg/kg/day)	%cPAD

General U.S. Population	0.0283	0.013777	49

All Infants (< 1 year old)

0.020762	73

Children 1-2 years old

0.023093	82

Children 3-5 years old

0.020811	74

Children 6-12 years old

0.014404	51

Youth 13-19 years old

0.011047	39

Adults 20-49 years old

0.012722	45

Adults 50+ years old

0.013610	48

Females 13-49 years old

0.012825	45

VI.	Characterization of Inputs/Outputs

The acute and chronic analyses assumed maximum field trial residues and
100% crop treated.  Therefore, the resulting exposure estimates are
conservative.  

VII.	Conclusions

ed potato; D277818, T. Bloem, 22-Apr-2004).  For ruminant commodities,
LOQ residues were assumed based on residues of concern ≤LOQ at 3.4x
the maximum reasonable dietary burden (MRDB; 3.4x was the highest level
tested; 180.6(a)(3) for hog and poultry).  The acute/chronic analyses
also incorporated the SCI-GROW ground water estimate resulting from
application of fenamidone to carrots (178 ppb; highest acute/chronic
estimate; 3 x 0.267 lb ai/acre).  The acute dietary exposure estimates
were (5% aPAD (95th%; children 1-2 years old were the most highly
exposed population) and the chronic dietary exposure estimates were (82%
cPAD (children 1-2 years old were the most highly exposed population)
and are therefore not of concern to HED.  

VIII.		List of Attachments

Attachment 1:	DEEM-FCID( acute and chronic residue file

Attachment 2:	DEEM-FCID( acute exposure estimates

Attachment 3:	DEEM-FCID( chronic exposure estimates

cc with all attachments: Tony Kish/Rosemary Kearns (RM 22); Barbara
Madden/Susan Stanton (RM 05)

T. Bloem:10945S:PY1:703-605-0217:75909P

Attachment 1:	DEEM-FCID( acute and chronic residue file

Filename: C:\Documents and Settings\tbloem\de runs\046679 acute and
chronic.R98

Chemical: fenamidone

RfD(Chronic): .0283 mg/kg bw/day  NOEL(Chronic): 2.83 mg/kg bw/day

RfD(Acute): 1.25 mg/kg bw/day  NOEL(Acute):  125 mg/kg bw/day

Date created/last modified: 05-24-2007/11:45:35/8          Program ver.
2.03

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  Commodity Name                    (ppm)       #1    #2   

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

95001280 O    Cottonseed, oil                    0.080000   1.000  1.000
 

95001281 O    Cottonseed, oil-babyfood           0.080000   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
 

95001790 O    Grape, wine and sherry             0.896000   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
 

86010000 O    Water, direct, all sources         0.178000   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.178000   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
 

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
 

24001890 M    Horse, meat                        0.150000   1.000  1.000
 

28002210 M    Meat, game                         0.150000   1.000  1.000
 

29003120 M    Rabbit, meat                       0.150000   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
 

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
 

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
 

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
 

01030820 1CD  Cassava                            0.080000   1.000  1.000
 

01030821 1CD  Cassava-babyfood                   0.080000   1.000  1.000
 

01031390 1CD  Dasheen, corm                      0.080000   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
 

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
 

01033660 1CD  Sweet potato                       0.080000   1.000  1.000
 

01033661 1CD  Sweet potato-babyfood              0.080000   1.000  1.000
 

01033710 1CD  Tanier, corm                       0.080000   1.000  1.000
 

01033870 1CD  Turmeric                           0.080000   1.000  1.000
 

01034060 1CD  Yam, true                          0.080000   1.000  1.000
 

01034070 1CD  Yam bean                           0.080000   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
 

03001980 3    Leek                               1.234000   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
 

03003380 3    Shallot                            0.186000   1.000  1.000
 

04010050 4A   Amaranth, leafy                   32.550000   1.000  1.000
 

04010180 4A   Arugula                           32.550000   1.000  1.000
 

04020760 4B   Cardoon                           20.160000   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
 

04011040 4A   Chrysanthemum, garland            32.550000   1.000  1.000
 

04011330 4A   Cress, garden                     32.550000   1.000  1.000
 

04011340 4A   Cress, upland                     32.550000   1.000  1.000
 

04011380 4A   Dandelion, leaves                 32.550000   1.000  1.000
 

04011500 4A   Endive                            32.550000   1.000  1.000
 

04021520 4B   Fennel, Florence                  20.160000   1.000  1.000
 

04012040 4A   Lettuce, head                     11.790000   1.000  1.000
 

04012050 4A   Lettuce, leaf                     17.580000   1.000  1.000
 

04012480 4A   Parsley, leaves                   32.550000   1.000  1.000
 

04013130 4A   Radicchio                         11.790000   1.000  1.000
 

04023220 4B   Rhubarb                           20.160000   1.000  1.000
 

04013550 4A   Spinach                           32.550000   1.000  1.000
 

04013551 4A   Spinach-babyfood                  32.550000   1.000  1.000
 

04023670 4B   Swiss chard                       20.160000   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
 

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
 

05010830 5A   Cauliflower                        3.270000   1.000  1.000
 

05021170 5B   Collards                          32.990000   1.000  1.000
 

05021940 5B   Kale                              32.990000   1.000  1.000
 

05011960 5A   Kohlrabi                           0.740000   1.000  1.000
 

05022290 5B   Mustard greens                    32.990000   1.000  1.000
 

05023180 5B   Rape greens                       32.990000   1.000  1.000
 

05023890 5B   Turnip, greens                    32.990000   1.000  1.000
 

08001480 8    Eggplant                           0.260000   1.000  1.000
 

08002340 8    Okra                               1.780000   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
 

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
 

09020210 9B   Balsam pear                        0.158000   1.000  1.000
 

09010750 9A   Cantaloupe                         0.158000   1.000  1.000
 

09010800 9A   Casaba                             0.158000   1.000  1.000
 

09020880 9B   Chayote, fruit                     0.158000   1.000  1.000
 

09021020 9B   Chinese waxgourd                   0.158000   1.000  1.000
 

09021350 9B   Cucumber                           0.158000   1.000  1.000
 

09011870 9A   Honeydew melon                     0.158000   1.000  1.000
 

09023080 9B   Pumpkin                            0.158000   1.000  1.000
 

09023090 9B   Pumpkin, seed                      0.158000   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
 

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
 

Attachment 2:	DEEM-FCID( acute exposure estimates

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: 046679 acute and chronic.R98        Adjustment factor #2
NOT used.

Analysis Date: 06-12-2007/10:25:57    Residue file dated:
05-24-2007/11:45:35/8

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:

  0.040621    3.25    3077    0.087575    7.01    1427    0.207317  
16.59     602  

U.S. Population (spring season):

  0.041226    3.30    3032    0.086645    6.93    1442    0.216701  
17.34     576  

U.S. Population (summer season):

  0.039145    3.13    3193    0.078310    6.26    1596    0.209195  
16.74     597  

U.S. Population (autumn season):

  0.041964    3.36    2978    0.095164    7.61    1313    0.172103  
13.77     726  

U.S. Population (winter season):

  0.040057    3.20    3120    0.085382    6.83    1464    0.195672  
15.65     638  

Northeast region:

  0.041291    3.30    3027    0.092473    7.40    1351    0.202589  
16.21     617  

Midwest region:

  0.037863    3.03    3301    0.070206    5.62    1780    0.162101  
12.97     771  

Southern region:

  0.039083    3.13    3198    0.089544    7.16    1395    0.228877  
18.31     546  

Western region:

  0.044069    3.53    2836    0.094525    7.56    1322    0.210696  
16.86     593  

Hispanics:

  0.038293    3.06    3264    0.077646    6.21    1609    0.217186  
17.37     575  

Non-hispanic whites:

  0.037964    3.04    3292    0.073461    5.88    1701    0.170027  
13.60     735  

Non-hispanic blacks:

  0.056831    4.55    2199    0.134450   10.76     929    0.293058  
23.44     426  

Non-hisp/non-white/non-black:

  0.063871    5.11    1957    0.122060    9.76    1024    0.285107  
22.81     438  

All infants:

  0.047689    3.82    2621    0.223876   17.91     558    0.626006  
50.08     199  

Nursing infants (<1 yr old):

  0.027202    2.18    4595    0.065414    5.23    1910    0.440068  
35.21     284  

Non-nursing infants (<1 yr old):

  0.050867    4.07    2457    0.311183   24.89     401    0.632743  
50.62     197  

Children 1-6  yrs:

  0.054002    4.32    2314    0.129682   10.37     963    0.416812  
33.34     299  

Children 7-12 yrs:

  0.040752    3.26    3067    0.077147    6.17    1620    0.175822  
14.07     710  

Females 13+ (preg/not nursing):

  0.030180    2.41    4141    0.072214    5.78    1730    0.077837   
6.23    1605  

Females 13+ (nursing):

  0.032754    2.62    3816    0.076011    6.08    1644    0.076291   
6.10    1638  

Females 13-19 (not preg or nursing):

  0.033249    2.66    3759    0.056920    4.55    2196    0.122620   
9.81    1019  

Females 20+ (not preg or nursing):

  0.041569    3.33    3007    0.093823    7.51    1332    0.201826  
16.15     619  

Females 13-50 yrs:

  0.039616    3.17    3155    0.076342    6.11    1637    0.165582  
13.25     754  

Males 13-19 yrs:

  0.036928    2.95    3384    0.099128    7.93    1260    0.209269  
16.74     597  

Males 20+ yrs:

  0.035559    2.84    3515    0.079044    6.32    1581    0.153817  
12.31     812  

Seniors 55+:

  0.040294    3.22    3102    0.095255    7.62    1312    0.170178  
13.61     734  

Children 1-2 yrs:

  0.059961    4.80    2084    0.153236   12.26     815    0.490447  
39.24     254  

Children 3-5 yrs:

  0.053302    4.26    2345    0.129054   10.32     968    0.430107  
34.41     290  

Children 6-12 yrs:

  0.041143    3.29    3038    0.080432    6.43    1554    0.194697  
15.58     642  

Youth 13-19 yrs:

  0.034314    2.75    3642    0.073298    5.86    1705    0.138004  
11.04     905  

Adults 20-49 yrs:

  0.037755    3.02    3310    0.076429    6.11    1635    0.162219  
12.98     770  

Adults 50+ yrs:

  0.040498    3.24    3086    0.094462    7.56    1323    0.175692  
14.06     711  

Females 13-49 yrs:

  0.039529    3.16    3162    0.075579    6.05    1653    0.201517  
16.12     620  

Attachment 3:	DEEM-FCID( chronic exposure estimates

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\tbloem\de runs\046679 acute
and chronic.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 06-12-2007/10:24:14     Residue file dated:
05-24-2007/11:45:35/8

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)                     0.013777               
48.7%

U.S. Population (spring season)             0.013841               
48.9%

U.S. Population (summer season)             0.013564               
47.9%

U.S. Population (autumn season)             0.013856               
49.0%

U.S. Population (winter season)             0.013852               
48.9%

Northeast region                            0.014107               
49.8%

Midwest region                              0.013261               
46.9%

Southern region                             0.012997               
45.9%

Western region                              0.015272               
54.0%

Hispanics                                   0.013561               
47.9%

Non-hispanic whites                         0.013143               
46.4%

Non-hispanic blacks                         0.015401               
54.4%

Non-hisp/non-white/non-black                0.020097               
71.0%

All infants (< 1 year)                      0.020762               
73.4%

Nursing infants                             0.008005               
28.3%

Non-nursing infants                         0.025604               
90.5%

Children 1-6  yrs                           0.021044               
74.4%

Children 7-12 yrs                           0.013823               
48.8%

Females 13-19 (not preg or nursing)         0.010473               
37.0%

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 or nursing)           0.013742                48.6%

Females 13-50 yrs                           0.012983               
45.9%

Females 13+ (preg/not nursing)              0.011111               
39.3%

Females 13+ (nursing)                       0.014770               
52.2%

Males 13-19 yrs                             0.011543               
40.8%

Males 20+ yrs                               0.012327               
43.6%

Seniors 55+                                 0.013565               
47.9%

Children 1-2 yrs                            0.023093               
81.6%

Children 3-5 yrs                            0.020811               
73.5%

Children 6-12 yrs                           0.014404               
50.9%

Youth 13-19 yrs                             0.011047               
39.0%

Adults 20-49 yrs                            0.012722               
45.0%

Adults 50+ yrs                              0.013610               
48.1%

Females 13-49 yrs                           0.012825               
45.3%

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

Fenamidone (046679)	Dietary-Exposure and Risk Assessment	DP #:  336201

page   PAGE  13  of   NUMPAGES  15