Document ID: EPA-HQ-OPP-2008-0556-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-08-03T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 Date:		12/23/2008

Subject:	Fenpyroximate.  Petition for the Establishment of Permanent
Tolerances for Residues on Fruiting Vegetable (Crop Group 8), Melon
(Crop Subgroup 9A), Cucumber, and Okra.  Acute and Chronic Dietary
Exposure and Risk Assessments.  

PC Code:  129131	DP Barcode:  357391

Decision No.:  394796	Registration Nos:  71711-4 and 71711-19

Petition No.:  8E7365	Regulatory Action:  Amended Sec. 3 Registration

Risk Assessment Type:  Dietary exposure assessment	Case No.:  NA

TXR No.:  NA	CAS No.:  134098-61-6 (E-isomer)

MRID No.:  None	40 CFR:  §180.566

From:		William D. Wassell, Chemist

		Registration Action Branch 1 (RAB1)

		Health Effects Division (HED, 7509P)

Through:		Thurston Morton, DESAC Reviewer

		Anant Parmar, DESAC Reviewer

		Dietary Exposure Science Advisory Council (DESAC)

	and

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

		RAB1/HED (7509P)

To:		William D. Wassell, Risk Assessor

		RAB1/HED (7509P)

Executive Summary

The acute and chronic dietary exposure and risk assessments 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).  The current assessment is being conducted in support of new uses
on fruiting vegetables (crop group 8), melon (crop subgroup 9A), okra,
and cucumber.

The acute analysis assumed DEEM™ (ver. 7.81) default processing
factors, 100% crop treated (CT), tolerance-level residues for all
commodities, DEEM( (ver. 7.81) default processing factors were assumed
for all commodities excluding apple, pear, and grape juice (0.11x);
grape, raisin (2.7x); orange, grapefruit, tangerine, lemon and lime
juice (0.06x); tomato paste (1.0x) and puree (1.0x); and peppermint and
spearmint oil (0.08x).  The acute analysis also incorporated the
drinking water estimates provided by Environmental Fate and Effects
Division (EFED).  The estimated drinking water concentrations (EDWCs)
were Tier 1 estimates for ground water using the SCI-GROW model
(Screening Concentration In GROund Water) and surface water using the
FIRST model (Food Quality Protection Act (FQPA) Index Reservoir
Screening Tool) for fenpyroximate and its degradates, M-1 and M-3.  The
models utilized an application rate of 0.2 lb ai/A with 2 applications
per season.  EDWCs of 0.00874 ppm and 0.00051 ppm were used in the acute
and chronic analysis, respectively.  The resulting acute food plus water
exposure estimates are not of concern to HED (<100% acute
population-adjusted dose (aPAD)) at the 95th percentile of the exposure
distribution for females 13 to 49 years old (the only population
subgroup of interest), the res  SEQ CHAPTER \h \r 1 ulting acute
exposure estimate for females 13 to 49 years old was 6.5% of the aPAD at
the 95th percentile of the exposure.  

DEEM™ (ver. 7.81) default processing factors, 100% CT, tolerance-level
residues for all commodities, and DEEM( (ver. 7.81) default processing
factors for most commodities (see above).  The chronic analysis also
incorporated the drinking water estimates provided by EFED (see above). 
The resulting chronic exposure estimates are not of concern to HED.  The
most highly exposed population was children 1-2 years old utilizing 38%
of the chronic PAD (cPAD).

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 a point-of-departure (POD; e.g., no-observable-adverse-effect-level
(NOAEL)) 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.  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 fenpyroximate dietary exposure assessment was conducted
by W. Cutchin (11/13/2006, D333528).

II.	Residue Information

Residues of Concern:  Acceptable plant metabolism studies with
fenpyroximate on apples, citrus, cotton, and grapes were previously
submitted.  HED has determined (Memo, J. Stokes, 8/12/03; DP# 292639)
that the residues of concern for plants for the purposes of tolerance
enforcement and risk assessment are fenpyroximate
4-[[[(E)-[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)

methylene]amino]oxy] methyl]benzoate plus its Z-isomer (also called
metabolite M-1 or 4-[[[(Z)-[(1,3-dimethyl-5-phenoxy-1H- pyrazol-4-yl)
methylene]amino]oxy]methyl]benzoate).  

The nature of residue in lactating goat is understood.  The HED
Metabolism Assessment Review Committee (MARC) concluded that for milk
and the fat, meat, and meat byproducts (excluding liver and kidney) of
cattle, goat, horse, and sheep, the parent compound, and its metabolites
(E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene
aminooxymethyl]benzoic acid and (E)-1,1-dimethylethyl-2-hydroxyethyl
4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene]amino]oxy]methyl
]benzoate, calculated as the parent compound (Memo, J. Stokes, 8/12/03;
DP# 292639).  Additionally, the residues of concern for cattle, goat,
horse, and sheep liver and kidney are fenpyroximate and its metabolite
(E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene
aminooxymethyl]benzoic acid, calculated as the parent compound.

For drinking water, the residues of concern for risk assessment include
the parent, M-1 and M-3.

Established/Recommended Tolerances:    SEQ CHAPTER \h \r 1 Fenpyroximate
tolerances are established in 40 CFR §180.566.  Tolerances for residues
in/on plant commodities are expressed in terms of the combined residues
of fenpyroximate and its Z-isomer.  Permanent tolerances for residues
in/on plant commodities, under §180.566(a)(1), range from 0.10 ppm (for
cotton undelinted seed, tree nut group 14, and pistachio) to 10 ppm (for
cotton gin byproducts, citrus oil, and hop, dried cones).  Tolerances
for residues in/on milk and the fat, meat, and meat byproducts
(excluding liver and kidney) of cattle, goat, horse, and sheep are
listed in 40 CFR §180.566(a)(2) and are expressed in terms of the
combined residues of fenpyroximate and its metabolites
(E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene
aminooxymethyl]benzoic acid and (E)-1,1-dimethylethyl-2-hydroxyethyl
4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene]amino]oxy]methyl
]benzoate, calculated as the parent compound.  Tolerances for residues
in cattle, goat, horse, and sheep liver and kidney are listed under 40
CFR §180.566(a)(3) at 0.25 ppm and are expressed in terms fenpyroximate
and its metabolite (E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene
aminooxymethyl]benzoic acid, calculated as the parent compound.  A
time-limited tolerance for residues in/on honey at 0.10 ppm with a
12/31/10 expiration date is listed in 40 CFR §180.566(b) under a
Section 18 Emergency Exemption.

The proposed uses and the submitted data support the establishment of
the following tolerances for   SEQ CHAPTER \h \r 1 the combined residues
of fenpyroximate and its Z-isomer as follows:

Vegetable, fruiting, group 8	0.20 ppm

Okra	0.20 ppm

Melon subgroup 9A	0.10 ppm

Cucumber	0.10 ppm

Residues used in the Acute and Chronic Analysis:  These analyses
employed tolerance-level residues for all commodities and DEEM( (ver.
7.81) default processing factors (as necessary), and empirical
processing factors for apple, pear, grape, orange, grapefruit, lemon,
and lime juice; grape, raisin; and peppermint and spearmint oil.

III.  Estimated Drinking Water Concentrations

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 EFED   SEQ CHAPTER \h \r
1 (Memo, 11/3/2008, W. Shaughnessy, DP Barcode:  354306).  The EDWCs
were Tier 1 estimates for ground water using the SCI-GROW model and
surface water using the FIRST model for fenpyroximate and its
metabolites .  The models utilized an application rate of 0.2 lb ai/A
with 2 applications per season.

  SEQ CHAPTER \h \r 1 Table 1.  Estimated Tier 1 Concentrations of
Fenpyroximate in Drinking Water.

Drinking Water Source	Upper Bound Estimated Drinking Water
Concentrations (ppb)

	Acute	Chronic

Surface Water	8.74	0.51

Groundwater	0.033 (Acute & Chronic)

EDWCs of 0.00874 ppm and 0.00051 ppm were used in the acute and chronic
analysis, respectively.

IV.	DEEM-FCID( Program and Consumption Information

Fenpyroximate 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 data).  The 1994-1996,
1998 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 toxicological endpoints as presented in the previous risk assessment
are summarized below in Table 2.

Table 2.  Summary of Toxicological Dose and Endpoints for Fenpyroximate
for Use in Human-Health                     Risk Assessment1.

Exposure

Scenario	Dose Used in Risk Assessment,

UF	Hazard and Exposure Based Special FQPA Safety Factor 

	Study and Toxicological Effects

Acute Dietary

females 13-50 years of age	NOAEL = 5.0 mg/kg/day

UF = 100

Acute RfD = 0.05 mg/kg/d	FQPA SF = 1X

aPAD = acute RfD

              FQPA SF

= 0.05 mg/kg/day	Prenatal Developmental Toxicity Study - rat

LOAEL = 25 mg/kg/day based on increase in the fetal incidence of
additional thoracic ribs.

Acute Dietary

general population including infants and children	N/A	N/A	N/A

Chronic Dietary

all populations	NOAEL= 0.97 mg/kg/d

UF = 100

Chronic RfD = 0.01 mg/kg/d	FQPA SF = 1X

cPAD = chronic RfD

             FQPA SF

= 0.01 mg/kg/day	Combined Oral Chronic Toxicity/carcinogenicity Study -
rat

LOAEL = 3.1 mg/kg/day based on decreased body weights, accompanied by
reduced food efficiency and a slight decrease in mean food consumption.

Cancer (oral, dermal, inhalation)	“not likely” to be carcinogenic to
humans	N/A	no evidence of carcinogenic potential in adequate
carcinogenicity studies in both rat and mouse.

1UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL =
no-observed-adverse-effect-level, LOAEL =
lowest-observed-adverse-effect-level, aPAD = acute population-adjusted
dose, cPAD = chronic population-adjusted dose, RfD = reference dose.

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

The resulting acute food plus water exposure estimates are not of
concern to HED (<100% aPAD) at the 95th percentile of the exposure   SEQ
CHAPTER \h \r 1 for females 13 to 49 years old was 6.5% of the aPAD. 
SEQ CHAPTER \h \r 1   Females 13 to 49 years old are the only population
subgroup of interest for acute exposure.  SEQ CHAPTER \h \r 1   See
Table 3 below for a summary of the results of the acute assessment.  The
resulting chronic exposure estimates are not of concern to HED.  The
most highly exposed population was children 1-2 years old utilizing 38%
of the cPAD.  See Table 4 below for a summary of the results of the
chronic assessment.

Table 3.  Summary of Acute Dietary Exposure and Risk for Fenpyroximate
at the 95th Percentile.

Population Subgroup	aPAD (mg/kg/day)	Exposure (mg/kg/day)	%aPAD

Females 13-49 years old	0.05	0.003259	6.5

Table 4.  Summary of Chronic Dietary Exposure and Risk for
Fenpyroximate.

Population Subgroup	cPAD (mg/kg/day)	Exposure (mg/kg/day)	%cPAD

General U.S. Population	0.01	0.001152	12

All Infants (< 1 year old)

0.001938	19

Children 1-2 years old

0.003754	38

Children 3-5 years old

0.002918	29

Children 6-12 years old

0.001508	15

Youth 13-19 years old

0.000689	6.9

Adults 20-49 years old

0.000876	8.8

Adults 50+ years old

0.000982	9.8

Females 13-49 years old

0.000820	8.2

VII.  Characterization of Inputs/Outputs

The acute and chronic analyses assumed tolerance-level residues, 100%
CT, DEEM( (ver. 7.81) default processing factors (as necessary), and
empirical processing factors for apple, pear, grape, orange, grapefruit,
lemon, and lime juice; grape, raisin; and peppermint and spearmint oil. 
These analyses are considered very conservative and could be refined
through the use of anticipated-residue estimates (ARs) for all
commodities, percent market share data for the proposed commodities, %CT
data for registered commodities, and/or additional empirical processing
factors.

VIII.  Conclusions

The acute and chronic dietary exposure and risk assessments were
conducted using DEEM-FCID(, ver. 2.03.  DEEM-FCID( incorporates food
consumption data from the USDA CSFII (1994-1996 and 1998).  

The acute analysis assumed tolerance-level residues, 100% CT, DEEM(
(ver. 7.81) default processing factors (as necessary), and empirical
processing factors for apple, pear, grape, orange, grapefruit, lemon,
and lime juice; grape, raisin; and peppermint and spearmint oil.  The
acute analysis also incorporated the drinking water estimates provided
by EFED.  The EDWCs were Tier 1 estimates for ground water using the
SCI-GROW model and surface water using the FIRST model for fenpyroximate
and its metabolites M-1 and M-3.  The models utilized an application
rate of 0.2 lb ai/A with 2 applications per season.  EDWCs of 0.00874
ppm and 0.00051 ppm were used in the acute and chronic analysis,
respectively.  The resulting acute food plus water exposure estimates
are not of concern to HED (<100% aPAD) at the 95th percentile of the
exposure distribution for females 13 to 49 years old (6.5%).    SEQ
CHAPTER \h \r 1 Females 13 to 49 years old are the only population
subgroup of interest for acute exposure.  SEQ CHAPTER \h \r 1 

The chronic analysis assumed tolerance-level residues, 100% CT, DEEM(
(ver. 7.81) default processing factors (as necessary), and empirical
processing factors for apple, pear, grape, orange, grapefruit, lemon,
and lime juice; grape, raisin; and peppermint and spearmint oil.  The
chronic analysis also incorporated the drinking water estimates provided
by EFED (see above).  The resulting chronic exposure estimates are not
of concern to HED.  The most highly-exposed population was children 1-2
years old utilizing 38% of the cPAD.

Attachment 1:  DEEM-FCID( Acute Residue File.

Attachment 2:  DEEM-FCID( Acute Exposure Estimates For The Females 13 To
50 Years Old.

Attachment 3:  DEEM-FCID( Chronic Residue File.

Attachment 4:  DEEM-FCID( Chronic Exposure Estimates.

RDI:  DE SAC Reviewers:  xx/xx/2008; G.F.Kramer: xx/xx/2008

DP No.:  357391

Petition No.:  8E7365

PC Code:  139131

W.D. Wassell:S10316:Potomac Yard:703-305-6135:7509P:RAB1

Attachment 1:  DEEM-FCID( Acute Residue File.

U.S. Environmental Protection Agency                                
Ver. 2.02

DEEM-FCID Acute analysis for FENPYROXIMATE

Residue file name: M:\Work Files\$ Fenpyroximate\DEEM\wdw-129131a.R98

Analysis Date 12-01-2008             Residue file dated:
12-01-2008/15:06:27/8

Reference dose: aRfD = 0.05 mg/kg bw/day  NOEL = 5 mg/kg bw/day

Comment: New uses on Fruiting vegetables (Group 8), Melons (Subgroup
9A), cucumber, and okra

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

14000030 14   Almond                             0.100000   1.000  1.000

14000031 14   Almond-babyfood                    0.100000   1.000  1.000

14000040 14   Almond, oil                        0.100000   1.000  1.000

14000041 14   Almond, oil-babyfood               0.100000   1.000  1.000

11000070 11   Apple, fruit with peel             0.400000   1.000  1.000

11000080 11   Apple, peeled fruit                0.400000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood       0.400000   1.000  1.000

11000090 11   Apple, dried                       0.400000   8.000  1.000

11000091 11   Apple, dried-babyfood              0.400000   8.000  1.000

11000100 11   Apple, juice                       0.400000   0.110  1.000

11000101 11   Apple, juice-babyfood              0.400000   0.110  1.000

11000110 11   Apple, sauce                       0.400000   1.000  1.000

11000111 11   Apple, sauce-babyfood              0.400000   1.000  1.000

21000440 M    Beef, meat                         0.030000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.030000   1.000  1.000

21000450 M    Beef, meat, dried                  0.030000   1.920  1.000

21000460 M    Beef, meat byproducts              0.030000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.030000   1.000  1.000

21000470 M    Beef, fat                          0.030000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.030000   1.000  1.000

21000480 M    Beef, kidney                       0.250000   1.000  1.000

21000490 M    Beef, liver                        0.250000   1.000  1.000

21000491 M    Beef, liver-babyfood               0.250000   1.000  1.000

14000590 14   Brazil nut                         0.100000   1.000  1.000

14000680 14   Butternut                          0.100000   1.000  1.000

09010750 9A   Cantaloupe                         0.100000   1.000  1.000

09010800 9A   Casaba                             0.100000   1.000  1.000

14000810 14   Cashew                             0.100000   1.000  1.000

14000920 14   Chestnut                           0.100000   1.000  1.000

10001060 10   Citrus citron                      0.600000   1.000  1.000

10001070 10   Citrus hybrids                     0.600000   1.000  1.000

10001080 10   Citrus, oil                       10.000000   1.000  1.000

95001280 O    Cottonseed, oil                    0.100000   1.000  1.000

95001281 O    Cottonseed, oil-babyfood           0.100000   1.000  1.000

11001290 11   Crabapple                          0.400000   1.000  1.000

09021350 9B   Cucumber                           0.100000   1.000  1.000

08001480 8    Eggplant                           0.200000   1.000  1.000

14001550 14   Filbert                            0.100000   1.000  1.000

14001560 14   Filbert, oil                       0.100000   1.000  1.000

23001690 M    Goat, meat                         0.030000   1.000  1.000

23001700 M    Goat, meat byproducts              0.030000   1.000  1.000

23001710 M    Goat, fat                          0.030000   1.000  1.000

23001720 M    Goat, kidney                       0.250000   1.000  1.000

23001730 M    Goat, liver                        0.250000   1.000  1.000

95001750 O    Grape                              1.000000   1.000  1.000

95001760 O    Grape, juice                       1.000000   0.110  1.000

95001761 O    Grape, juice-babyfood              1.000000   0.110  1.000

95001770 O    Grape, leaves                      1.000000   1.000  1.000

95001780 O    Grape, raisin                      1.000000   2.700  1.000

95001790 O    Grape, wine and sherry             1.000000   1.000  1.000

10001800 10   Grapefruit                         0.600000   1.000  1.000

10001810 10   Grapefruit, juice                  0.600000   0.060  1.000

14001850 14   Hickory nut                        0.100000   1.000  1.000

95001860 O    Honey                              0.100000   1.000  1.000

95001861 O    Honey-babyfood                     0.100000   1.000  1.000

09011870 9A   Honeydew melon                     0.100000   1.000  1.000

95001880 O    Hop                               10.000000   1.000  1.000

24001890 M    Horse, meat                        0.030000   1.000  1.000

10001970 10   Kumquat                            0.600000   1.000  1.000

10001990 10   Lemon                              0.600000   1.000  1.000

10002000 10   Lemon, juice                       0.600000   0.060  1.000

10002001 10   Lemon, juice-babyfood              0.600000   0.060  1.000

10002010 10   Lemon, peel                        0.600000   1.000  1.000

10002060 10   Lime                               0.600000   1.000  1.000

10002070 10   Lime, juice                        0.600000   0.060  1.000

10002071 10   Lime, juice-babyfood               0.600000   0.060  1.000

11002100 11   Loquat                             0.400000   1.000  1.000

14002130 14   Macadamia nut                      0.100000   1.000  1.000

27002220 D    Milk, fat                          0.015000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.015000   1.000  1.000

27012230 D    Milk, nonfat solids                0.015000   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.015000   1.000  1.000

27022240 D    Milk, water                        0.015000   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.015000   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.015000   1.000  1.000

08002340 8    Okra                               0.200000   1.000  1.000

10002400 10   Orange                             0.600000   1.000  1.000

10002410 10   Orange, juice                      0.600000   0.060  1.000

10002411 10   Orange, juice-babyfood             0.600000   0.060  1.000

10002420 10   Orange, peel                       0.600000   1.000  1.000

11002660 11   Pear                               0.400000   1.000  1.000

11002661 11   Pear-babyfood                      0.400000   1.000  1.000

11002670 11   Pear, dried                        0.400000   6.250  1.000

11002680 11   Pear, juice                        0.400000   0.110  1.000

11002681 11   Pear, juice-babyfood               0.400000   0.110  1.000

14002690 14   Pecan                              0.100000   1.000  1.000

08002700 8    Pepper, bell                       0.200000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.200000   1.000  1.000

08002710 8    Pepper, bell, dried                0.200000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.200000   1.000  1.000

08002720 8    Pepper, nonbell                    0.200000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.200000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.200000   1.000  1.000

95002750 O    Peppermint                         7.000000   1.000  1.000

95002760 O    Peppermint, oil                    7.000000   0.080  1.000

14002820 14   Pistachio                          0.100000   1.000  1.000

10003070 10   Pummelo                            0.600000   1.000  1.000

11003100 11   Quince                             0.400000   1.000  1.000

26003390 M    Sheep, meat                        0.030000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.030000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.030000   1.000  1.000

26003410 M    Sheep, fat                         0.030000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.030000   1.000  1.000

26003420 M    Sheep, kidney                      0.250000   1.000  1.000

26003430 M    Sheep, liver                       0.250000   1.000  1.000

95003520 O    Spearmint                          7.000000   1.000  1.000

95003530 O    Spearmint, oil                     7.000000   0.080  1.000

10003690 10   Tangerine                          0.600000   1.000  1.000

10003700 10   Tangerine, juice                   0.600000   0.060  1.000

08003740 8    Tomatillo                          0.200000   1.000  1.000

08003750 8    Tomato                             0.200000   1.000  1.000

08003751 8    Tomato-babyfood                    0.200000   1.000  1.000

08003760 8    Tomato, paste                      0.200000   1.000  1.000

08003761 8    Tomato, paste-babyfood             0.200000   1.000  1.000

08003770 8    Tomato, puree                      0.200000   1.000  1.000

08003771 8    Tomato, puree-babyfood             0.200000   1.000  1.000

08003780 8    Tomato, dried                      0.200000  19.300  1.000

08003781 8    Tomato, dried-babyfood             0.200000  19.300  1.000

08003790 8    Tomato, juice                      0.200000   1.500  1.000

14003910 14   Walnut                             0.100000   1.000  1.000

86010000 O    Water, direct, all sources         0.008740   1.000  1.000

86020000 O    Water, indirect, all sources       0.008740   1.000  1.000

09013990 9A   Watermelon                         0.100000   1.000  1.000

09014000 9A   Watermelon, juice                  0.100000   1.000  1.000

Attachment 2:  DEEM-FCID( Acute Exposure Estimates for

Females 13 to 50 Years Old.

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: wdw-129131a.R98                     Adjustment factor #2
NOT used.

Analysis Date: 12-01-2008/15:08:25    Residue file dated:
12-01-2008/15:06:27/8

NOEL (Acute) =   5.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "New uses on Fruiting vegetables (Group 8), Melons
(Subgroup 9A),

 cucumber, and okra"

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

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

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

Females 13-49 yrs:

  0.003299    6.60    1515    0.007222   14.44     692    0.013147  
26.29     380  

Attachment 3:  DEEM-FCID( Chronic Residue File.

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FENPYROXIMATE                     
1994-98 data

Residue file: M:\Work Files\$ Fenpyroximate\DEEM\wdw-129131c.R98

                                                           Adjust. #2
NOT used

Analysis Date 12-01-2008             Residue file dated:
12-01-2008/15:06:59/8

Reference dose (RfD) = 0.01 mg/kg bw/day

Comment:New uses on Fruiting vegetables (group 8), Melon (subgroup 9A),
cucumber, and okra

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

14000030 14   Almond                             0.100000   1.000     
1.000   

14000031 14   Almond-babyfood                    0.100000   1.000     
1.000   

14000040 14   Almond, oil                        0.100000   1.000     
1.000   

14000041 14   Almond, oil-babyfood               0.100000   1.000     
1.000   

11000070 11   Apple, fruit with peel             0.400000   1.000     
1.000   

11000080 11   Apple, peeled fruit                0.400000   1.000     
1.000   

11000081 11   Apple, peeled fruit-babyfood       0.400000   1.000     
1.000   

11000090 11   Apple, dried                       0.400000   8.000     
1.000   

11000091 11   Apple, dried-babyfood              0.400000   8.000     
1.000   

11000100 11   Apple, juice                       0.400000   0.110     
1.000   

11000101 11   Apple, juice-babyfood              0.400000   0.110     
1.000   

11000110 11   Apple, sauce                       0.400000   1.000     
1.000   

11000111 11   Apple, sauce-babyfood              0.400000   1.000     
1.000   

21000440 M    Beef, meat                         0.030000   1.000     
1.000   

21000441 M    Beef, meat-babyfood                0.030000   1.000     
1.000   

21000450 M    Beef, meat, dried                  0.030000   1.920     
1.000   

21000460 M    Beef, meat byproducts              0.030000   1.000     
1.000   

21000461 M    Beef, meat byproducts-babyfood     0.030000   1.000     
1.000   

21000470 M    Beef, fat                          0.030000   1.000     
1.000   

21000471 M    Beef,fat-babyfood                  0.030000   1.000     
1.000   

21000480 M    Beef, kidney                       0.250000   1.000     
1.000   

21000490 M    Beef, liver                        0.250000   1.000     
1.000   

21000491 M    Beef, liver-babyfood               0.250000   1.000     
1.000   

14000590 14   Brazil nut                         0.100000   1.000     
1.000   

14000680 14   Butternut                          0.100000   1.000     
1.000   

09010750 9A   Cantaloupe                         0.100000   1.000     
1.000   

09010800 9A   Casaba                             0.100000   1.000     
1.000   

14000810 14   Cashew                             0.100000   1.000     
1.000   

14000920 14   Chestnut                           0.100000   1.000     
1.000   

10001060 10   Citrus citron                      0.600000   1.000     
1.000   

10001070 10   Citrus hybrids                     0.600000   1.000     
1.000   

10001080 10   Citrus, oil                       10.000000   1.000     
1.000   

95001280 O    Cottonseed, oil                    0.100000   1.000     
1.000   

95001281 O    Cottonseed, oil-babyfood           0.100000   1.000     
1.000   

11001290 11   Crabapple                          0.400000   1.000     
1.000   

08001480 8    Eggplant                           0.200000   1.000     
1.000   

14001550 14   Filbert                            0.100000   1.000     
1.000   

14001560 14   Filbert, oil                       0.100000   1.000     
1.000   

23001690 M    Goat, meat                         0.030000   1.000     
1.000   

23001700 M    Goat, meat byproducts              0.030000   1.000     
1.000   

23001710 M    Goat, fat                          0.030000   1.000     
1.000   

23001720 M    Goat, kidney                       0.250000   1.000     
1.000   

23001730 M    Goat, liver                        0.250000   1.000     
1.000   

95001750 O    Grape                              1.000000   1.000     
1.000   

95001760 O    Grape, juice                       1.000000   0.110     
1.000   

95001761 O    Grape, juice-babyfood              1.000000   0.110     
1.000   

95001770 O    Grape, leaves                      1.000000   1.000     
1.000   

95001780 O    Grape, raisin                      1.000000   2.700     
1.000   

95001790 O    Grape, wine and sherry             1.000000   1.000     
1.000   

10001800 10   Grapefruit                         0.600000   1.000     
1.000   

10001810 10   Grapefruit, juice                  0.600000   0.060     
1.000   

14001850 14   Hickory nut                        0.100000   1.000     
1.000   

95001860 O    Honey                              0.100000   1.000     
1.000   

95001861 O    Honey-babyfood                     0.100000   1.000     
1.000   

09011870 9A   Honeydew melon                     0.100000   1.000     
1.000   

95001880 O    Hop                               10.000000   1.000     
1.000   

24001890 M    Horse, meat                        0.030000   1.000     
1.000   

10001970 10   Kumquat                            0.600000   1.000     
1.000   

10001990 10   Lemon                              0.600000   1.000     
1.000   

10002000 10   Lemon, juice                       0.600000   0.060     
1.000   

10002001 10   Lemon, juice-babyfood              0.600000   0.060     
1.000   

10002010 10   Lemon, peel                        0.600000   1.000     
1.000   

10002060 10   Lime                               0.600000   1.000     
1.000   

10002070 10   Lime, juice                        0.600000   0.060     
1.000   

10002071 10   Lime, juice-babyfood               0.600000   0.060     
1.000   

11002100 11   Loquat                             0.400000   1.000     
1.000   

14002130 14   Macadamia nut                      0.100000   1.000     
1.000   

27002220 D    Milk, fat                          0.015000   1.000     
1.000   

27002221 D    Milk, fat - baby food/infant for   0.015000   1.000     
1.000   

27012230 D    Milk, nonfat solids                0.015000   1.000     
1.000   

27012231 D    Milk, nonfat solids-baby food/in   0.015000   1.000     
1.000   

27022240 D    Milk, water                        0.015000   1.000     
1.000   

27022241 D    Milk, water-babyfood/infant form   0.015000   1.000     
1.000   

27032251 D    Milk, sugar (lactose)-baby food/   0.015000   1.000     
1.000   

08002340 8    Okra                               0.200000   1.000     
1.000   

10002400 10   Orange                             0.600000   1.000     
1.000   

10002410 10   Orange, juice                      0.600000   0.060     
1.000   

10002411 10   Orange, juice-babyfood             0.600000   0.060     
1.000   

10002420 10   Orange, peel                       0.600000   1.000     
1.000   

11002660 11   Pear                               0.400000   1.000     
1.000   

11002661 11   Pear-babyfood                      0.400000   1.000     
1.000   

11002670 11   Pear, dried                        0.400000   6.250     
1.000   

11002680 11   Pear, juice                        0.400000   0.110     
1.000   

11002681 11   Pear, juice-babyfood               0.400000   0.110     
1.000   

14002690 14   Pecan                              0.100000   1.000     
1.000   

08002700 8    Pepper, bell                       0.200000   1.000     
1.000   

08002701 8    Pepper, bell-babyfood              0.200000   1.000     
1.000   

08002710 8    Pepper, bell, dried                0.200000   1.000     
1.000   

08002711 8    Pepper, bell, dried-babyfood       0.200000   1.000     
1.000   

08002720 8    Pepper, nonbell                    0.200000   1.000     
1.000   

08002721 8    Pepper, nonbell-babyfood           0.200000   1.000     
1.000   

08002730 8    Pepper, nonbell, dried             0.200000   1.000     
1.000   

95002750 O    Peppermint                         7.000000   1.000     
1.000   

95002760 O    Peppermint, oil                    7.000000   0.080     
1.000   

14002820 14   Pistachio                          0.100000   1.000     
1.000   

10003070 10   Pummelo                            0.600000   1.000     
1.000   

11003100 11   Quince                             0.400000   1.000     
1.000   

26003390 M    Sheep, meat                        0.030000   1.000     
1.000   

26003391 M    Sheep, meat-babyfood               0.030000   1.000     
1.000   

26003400 M    Sheep, meat byproducts             0.030000   1.000     
1.000   

26003410 M    Sheep, fat                         0.030000   1.000     
1.000   

26003411 M    Sheep, fat-babyfood                0.030000   1.000     
1.000   

26003420 M    Sheep, kidney                      0.250000   1.000     
1.000   

26003430 M    Sheep, liver                       0.250000   1.000     
1.000   

95003520 O    Spearmint                          7.000000   1.000     
1.000   

95003530 O    Spearmint, oil                     7.000000   0.080     
1.000   

10003690 10   Tangerine                          0.600000   1.000     
1.000   

10003700 10   Tangerine, juice                   0.600000   0.060     
1.000   

08003740 8    Tomatillo                          0.200000   1.000     
1.000   

08003750 8    Tomato                             0.200000   1.000     
1.000   

08003751 8    Tomato-babyfood                    0.200000   1.000     
1.000   

08003760 8    Tomato, paste                      0.200000   1.000     
1.000   

08003761 8    Tomato, paste-babyfood             0.200000   1.000     
1.000   

08003770 8    Tomato, puree                      0.200000   1.000     
1.000   

08003771 8    Tomato, puree-babyfood             0.200000   1.000     
1.000   

08003780 8    Tomato, dried                      0.200000  19.300     
1.000   

08003781 8    Tomato, dried-babyfood             0.200000  19.300     
1.000   

08003790 8    Tomato, juice                      0.200000   1.500     
1.000   

14003910 14   Walnut                             0.100000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.000510   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.000510   1.000     
1.000   

09013990 9A   Watermelon                         0.100000   1.000     
1.000   

09014000 9A   Watermelon, juice                  0.100000   1.000     
1.000   

Attachment 4:  DEEM-FCID( Chronic Exposure Estimates.

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: M:\Work Files\$ Fenpyroximate\DEEM\wdw-129131c.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 12-01-2008/15:09:55     Residue file dated:
12-01-2008/15:06:59/8

Reference dose (RfD, Chronic) = .01 mg/kg bw/day

COMMENT 1: New uses on Fruiting vegetables (group 8), Melon (subgroup
9A), cucumber, and okra

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.001157               
11.6%

U.S. Population (spring season)             0.001160               
11.6%

U.S. Population (summer season)             0.001119               
11.2%

U.S. Population (autumn season)             0.001145               
11.4%

U.S. Population (winter season)             0.001209               
12.1%

Northeast region                            0.001257               
12.6%

Midwest region                              0.001126               
11.3%

Southern region                             0.000968                
9.7%

Western region                              0.001400               
14.0%

Hispanics                                   0.001278               
12.8%

Non-hispanic whites                         0.001179               
11.8%

Non-hispanic blacks                         0.000884                
8.8%

Non-hisp/non-white/non-black                0.001283               
12.8%

All infants (< 1 year)                      0.001940               
19.4%

Nursing infants                             0.001167               
11.7%

Non-nursing infants                         0.002233               
22.3%

Children 1-6  yrs                           0.003055               
30.5%

Children 7-12 yrs                           0.001415               
14.2%

Females 13-19 (not preg or nursing)         0.000650                
6.5%

Females 20+ (not preg or nursing)           0.000917                
9.2%

Females 13-50 yrs                           0.000920                
9.2%

Females 13+ (preg/not nursing)              0.000849                
8.5%

Females 13+ (nursing)                       0.001015               
10.1%

Males 13-19 yrs                             0.000729                
7.3%

Males 20+ yrs                               0.000924                
9.2%

Seniors 55+                                 0.001014               
10.1%

Children 1-2 yrs                            0.003761               
37.6%

Children 3-5 yrs                            0.002922               
29.2%

Children 6-12 yrs                           0.001511               
15.1%

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                       0.000691                 6.9%

Adults 20-49 yrs                            0.000881                
8.8%

Adults 50+ yrs                              0.000991                
9.9%

Females 13-49 yrs                           0.000824                
8.2%

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

Page   PAGE  1  of   NUMPAGES  15