Document ID: EPA-HQ-OPP-2006-0875-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-03-25T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  11/26/2008

SUBJECT:	Fenpropathrin.  Request for Tolerances for Barley, Stone Fruits
(Crop Group 12), Tree Nuts including Pistachio (Crop Group 14);
Caneberries (Crop Subgroup    13-07A), Olives, Avocado, Black Sapote,
Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, and Star Apple. 
Summary of Analytical Chemistry and Residue Data.

PC Code:  127901	DP Barcodes:  D320347, D333113, D333284, D347513,
D347896, D348247, and D353915

Decision Nos.:  351279, 366994, & 386849	Registration No.:  59639-35

Petition Nos.:  6E7066, 4E6867, and 7E7298	Regulatory Action:  Section 3

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  39515-41-8

MRID Nos.:  46385302-06, 46814801-02,

                      and 47295501-02 	40 CFR:  180.466

 							

FROM:	Anant Parmar, Biologist  	  SEQ CHAPTER \h \r 1 

		Registration Action Branch 2/Health Effects Division (7509P)

THROUGH:	Douglas Dotson, Ph.D., Chemist

		Registration Action Branch 2/Health Effects Division (7509P)

			and

  SEQ CHAPTER \h \r 1 				

		William H. Donovan, Ph.D., Senior Scientist

		Registration Action Branch 3/Health Effects Division (7509P)

	

TO:		Sidney Jackson/Barbara Madden, RIMUERB

		Olga Odiott, Insecticide Branch

	Registration Division (7505P)  SEQ CHAPTER \h \r 1 					  SEQ CHAPTER
\h \r 1   SEQ CHAPTER \h \r 1 

  SEQ CHAPTER \h \r 1 This DER was originally prepared under contract by
Dynamac Corporation (2275 Research Boulevard, Suite 300; Rockville, MD
20850; submitted 04/30/2008).  It has been reviewed by the Health
Effects Division (HED) and revised to reflect current Office of
Pesticide Programs (OPP) policies.

Executive Summary

Fenpropathrin [cyano(3-phenoxyphenyl) methyl
2,2,3,3-tetramethylcyclopropanecarboxylate] is an ingestion and contact
pyrethroid insecticide and acaricide currently registered for use on
fruit trees, vegetables, field crops, and ornamental plants for the
control of various insect pests and mites.  The Agency has received
three separate tolerance petitions to establish permanent tolerances for
residues of fenpropathrin in/on various raw agricultural commodities,
crop groups, and/or subgroups.  This document summarizes the available
residue chemistry data in support of these tolerance petitions.

Under PP#4E6867, Valent U.S.A. Corporation requested the establishment
of tolerances for residues of the insecticide fenpropathrin in/on:

Stone Fruit, Crop Group 12	5.0 ppm

Tree Nuts (including Pistachio), Crop Group 14	0.10 ppm

Almond Hulls	5.0 ppm

Under PP#6E7066, the Interregional Research Project No. 4 (IR-4), on
behalf of the Agricultural Experiment Stations of FL, TX, ID, ND, and
SD, requests the establishment of tolerances for residues of
fenpropathrin in/on:

Avocado	1.0 ppm

Black sapote	1.0 ppm

Canistel	1.0 ppm

Mamey sapote	1.0 ppm

Mango	1.0 ppm

Papaya	1.0 ppm

Sapodilla	1.0 ppm

Star apple	1.0 ppm

Barley, grain	0.30 ppm

Barley, hay	2.5 ppm

Barley, straw	4.5 ppm

Under PP#7E7298, the IR-4, on behalf of the Agricultural Experiment
Stations of CA, MI, PA, and TN, requests the establishment of tolerances
for residues of fenpropathrin in/on:

Caneberry subgroup 13A	12 ppm

Olive	5.0 ppm

Tolerances for residues of fenpropathrin are established in 40 CFR
§180.466.  The tolerance expression is in terms of fenpropathrin per
se.  Fenpropathrin tolerances for plant commodities range from 0.01 ppm
(peanut) to 75 ppm (citrus oil).  Fenpropathrin tolerances for animal
commodities range from 0.05 ppm (egg and the fat, meat, and meat
byproducts of poultry) to 2.0 ppm (milk fat reflecting 0.08 ppm in whole
milk).  A time-limited tolerance (with an expiration date of 12/31/08)
is established under 40 CFR §180.466(b) for currant at 15 ppm.

The end-use product relevant for this registration action is Danitol®
2.4 EC Spray (EPA Reg. No. 59639-35), an emulsifiable concentrate
formulation containing 30.9% ai (equivalent to 2.4 lb ai/gal).  The
petitioners wish to amend the product label for Danitol® 2.4 EC Spray
to include new uses on the crops addressed herein.  Danitol® is
proposed for multiple foliar spray treatments at maximum seasonal rates
of:  0.2 lb ai/A for barley; 0.6 lb ai/A for caneberrries; and 0.8 lb
ai/A for stone fruits, tree nuts, olives, and tropical and subtropical
fruits.  The proposed preharvest intervals (PHI) range from 1 to 14
days.

The nature of the residue in plants is adequately understood based on
acceptable metabolism studies conducted on apple, cotton, pinto beans,
and tomatoes.  The nature of the residue in animals is adequately
understood based on acceptable metabolism studies conducted on goat and
poultry.  The terminal residue of concern for the purpose of tolerance
expression is the parent compound.

The nature of the residue in rotational crops is adequately understood. 
In its review of a confined rotational crop study, HED has determined
that, with the exception of a soil metabolite which may have occurred in
rotated lettuce and carrots from soil contamination, the same
metabolites were seen in the confined rotational crop study as in the
primary plant and livestock metabolism studies and rat metabolism
studies.  In a limited field rotational crop study, no detectable
residues of fenpropathrin were found in any rotated carrot, lettuce, or
wheat samples at any of the plantback intervals (~30, 120, and 365
days).  Based on these studies, HED has determined that no fenpropathrin
rotational crop tolerances or restrictions are required for the crops
that are presently registered.  This conclusion applies as well to the
rotatable crops addressed herein.

There are adequate enforcement methods, gas chromatography using an
electron capture detector (GC/ECD), for the determination of
fenpropathrin residues in/on plants (RM-22-4, revised 5/3/93) and
animals (RM-22A-1).  The limit of detection (LOD) for Method RM-22-4 is
0.01 ppm.  The lowest limits of method validation (LLMV) for Method
RM-22A-1 were 0.05 ppm in milk and 0.5 ppm in fat and meat.  In
addition, the   SEQ CHAPTER \h \r 1 recovery of fenpropathrin was tested
through FDA multiresidue methods, and fenpropathrin was found to be
completely recovered by the PAM I Section 302 Method (Luke Method).  The
data collection method used to analyze samples from the submitted field
trials and processing study was Method RM-22-4 or its modification.  The
adequacy of Method RM-22-4 (and/or its modifications) for data
collection was verified and demonstrated by fortifying control samples
with fenpropathrin at levels approximating field-incurred residues.

There are adequate storage stability data to support the integrity of
samples collected from the field and processing studies.  There are no
corrections that need to be applied, as fenpropathrin residues of
concern were found to be relatively stable over a wide range of
commodities under frozen storage conditions.

The proposed uses include livestock feedstuffs such as almond hulls and
barley grain, hay, and straw.  The available ruminant and poultry
feeding data are adequate to cover secondary residues resulting from the
livestock feedstuffs cited above as well as from feedstuffs with
registered uses.  The dietary burdens of fenpropathrin to livestock were
recalculated using the most recent guidance from HED concerning
revisions of feedstuff percentages in Table 1 and constructing maximum
reasonably balanced livestock diets (MRBDs).  Based on the dietary
exposure levels and the residue data from an available ruminant feeding
study, the existing fenpropathrin tolerances could be lowered or
removed.  Based on the dietary exposure levels and the residue data from
an available poultry feeding study, the existing fenpropathrin
tolerances of 0.05 ppm for egg, fat, meat, and meat byproducts of
poultry are adequate to support the proposed uses on barley.

The submitted residue data for cherries, peaches, and plums are adequate
to support the establishment of a fenpropathrin tolerance for Stone
Fruits (Crop Group 12).  The field trials were conducted according to
the proposed use rate and PHI.  The maximum residues of fenpropathrin
in/on treated samples were 0.58 ppm for plums, 1.11 ppm for peaches, and
3.53 ppm for cherries.  HED recommends in favor of the proposed
tolerance of 1.4 ppm for residues of fenpropathrin per se in/on Stone
Fruits except cherry (Crop Group 12).  The recommended tolerance for
cherry sweet and tart is 5.0 ppm.  

The submitted residue data for almonds and pecans are adequate to
support the establishment of fenpropathrin tolerances for Tree Nuts
(Crop Group 14) as well as for almond hulls.  The field trials were
conducted according to the proposed use rate and PHI.  The maximum
residues of fenpropathrin in/on treated samples were 0.05 ppm for pecan
nutmeat, 0.03 ppm for almond nutmeat, and 4.3 ppm for almond hulls.  HED
recommends in favor of the proposed tolerance of 0.10 ppm for residues
of fenpropathrin per se in/on Tree Nuts (Crop Group 14).  The
recommended tolerance for almond hulls is 4.5 ppm.  The almond and pecan
data will be translated to pistachio.

The submitted residue data for avocado are adequate.  The avocado trials
were conducted according to the proposed use rate and PHI.  The maximum
residues of fenpropathrin were 0.58 ppm in/on treated avocado samples. 
HED recommends in favor of the proposed tolerance of 1.0 ppm for
residues of fenpropathrin per se in/on avocado.  The avocado data will
be translated to support the proposed uses on black sapote, canistel,
mamey sapote, mango, sapodilla, and star apple.  No residue decline data
were submitted for avocado.

The submitted residue data are not adequate to support the establishment
of a fenpropathrin tolerance for barley.  A barley processing study is
required for HED to complete its review of the proposed use on barley. 
The proposed label should be revised to specify appropriate preharvest
intervals.  The barley field trials were conducted according to the
proposed use rate and PHIs of 15-60 days for hay and 45-96 days for
straw and grain; the petitioner has proposed a 14-day PHI for uses on
barley.  The maximum residues of fenpropathrin were 0.038 ppm for barley
grain, 1.27 ppm for barley straw, and 2.05 ppm for barley hay.  HED
recommends tolerances of 0.04 ppm, 2.5 ppm, and 4.0 ppm for residues of
fenpropathrin per se in/on barley grain, hay, and straw, respectively.

The submitted residue data for raspberry and blackberry and are adequate
to support the establishment of a fenpropathrin tolerance for the
Caneberry Subgroup (13-07A).  The field trials were conducted at a
slightly exaggerated rate (1.3x the maximum proposed seasonal rate of
0.6 lb) and reflect the proposed 3-day PHI.  The maximum residues of
fenpropathrin in/on treated samples were 7.1 ppm.  HED recommends in
favor of the proposed tolerance of 12.0 ppm for residues of
fenpropathrin per se in/on the Caneberry Subgroup (13-07A).  The
registrant needs to submit a revised Section F in which tolerances are
proposed for the updated Crop Subgroup 13-07A, as opposed to Subgroup
13-A.  No residue decline data were submitted for raspberries or
blackberries.

The submitted residue data for olives are adequate.  The olive trials
were conducted according to the proposed use rate and PHI.  The maximum
residues of fenpropathrin were 3.7 ppm in/on treated olive samples
collected at a 7- to 8-day PHI.  HED recommends in favor of the proposed
tolerance of 5.0 ppm for residues of fenpropathrin per se in/on olives.

There are adequate processing data for olives and plums.  Residues of
fenpropathrin marginally concentrated in olive oil (processing factor of
1.07x) whereas residues concentrated more noticeably in dry prunes
(2.6x) following processing of respective RACs bearing quantifiable
residues.  Based on these data, tolerances are not needed for residues
of fenpropathrin in olive oil or dried prunes.  Barley processing data
were not submitted.  These data are needed, however, to support the
proposed use of fenpropathrin on barley.

Codex and Mexican maximum residue limits (MRLs) are established for
residues of fenpropathrin, but no limits are listed for the crop
commodities addressed herein.  No Canadian MRLs are established for
fenpropathrin.

Analytical reference standards for fenpropathrin are currently available
at the EPA National Pesticide Standards Repository.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

Pending label revisions (see requirements under 860.1200 Directions for
Use, the submission of barley processing data (see requirements under
860.1520 Processed Food and Feed), and the submission of a revised
Section F (see requirements under 860.1550 Proposed Tolerances), there
are no residue chemistry issues that would preclude granting a
conditional registration for the requested uses of fenpropathrin on the
crops, subgroups, or crop groups addressed herein, except for barley. 
The proposed barley use requires the submission of a barley processing
study.  HED will complete its review of the residue data for the
proposed use on barley upon receipt of the barley processing study.  The
remaining registrations should be made conditional pending resolution of
the data gaps detailed below by guideline topic.  The proposed uses and
the submitted and/or translated data support the following tolerances
for residues of fenpropathrin in/on the following raw agricultural
commodities, subgroups, and crop groups:

PP#4E6867

Fruit, Stone, Group 12 except Cherry	1.4 ppm

Cherry, sweet & tart	5.0 ppm

Nut, Tree, Group 14	0.10 ppm

Almond, hulls	4.5 ppm

Pistachio	0.10 ppm

PP#6E7066

Avocado	1.0 ppm

Black sapote	1.0 ppm

Canistel	1.0 ppm

Mamey sapote	1.0 ppm

Mango	1.0 ppm

Papaya	1.0 ppm

Sapodilla	1.0 ppm

Star apple	1.0 ppm

Barley, grain	Withheld

Barley, hay	Withheld

Barley, straw	Withheld

PP#7E7298

Caneberry Subgroup (13-07A)	12.0 ppm

Olive	5.0 ppm

860.1200 Directions for Use

As HED is not recommending in favor of tolerances for barley commodities
at this time, barley should be removed from the label.  At such time as
the registrant submits the barley processing study, the registrant
should also submit a proposed label that specifies a PHI of 15 days for
barley hay and 45 days for barley grain and straw.

The proposed label for tropical fruits states the following with respect
to the proposed commodities:  “Tropical and Subtropical Fruit
(Inedible Peel) – including but not limited to:  Avocado, Canistel,
Mango, Papaya, Sapodilla, Black Sapote, Mamey Sapote, Star Apple.” 
The words “including but not limited to” must be removed from the
label.  

860.1520  Processed Food and Feed

A barley processing study needs to be submitted.  Upon completion and
review of an acceptable barley processing study, HED will make
recommendations regarding the requested use on barley and the need for
tolerances on barley commodities.

860.1550 Proposed Tolerances

The petitioner should submit a revised Section F that incorporates the
recommended tolerances presented in Table 16.

Background

The chemical structure and nomenclature of fenpropathrin are presented
in Table 1, and the physicochemical properties of the technical grade
chemical are presented in Table 2.

Table 1.	   Fenpropathrin Nomenclature.

Chemical structure	

Common name	Fenpropathrin

Company experimental name	WC-4741706 (Shell); S-5206 (Sumitomo)

IUPAC name	(RS)-α-cyano-3-phenoxybenzyl
2,2,3,3-tetramethylcyclopropanecarboxylate

CAS name	Cyano(3-phenoxyphenyl) methyl
2,2,3,3-tetramethylcyclopropanecarboxylate

CAS registry number	39515-41-8

End-use product (EP)	2.4 lb/gal EC formulation (Danitol® 2.4 EC Spray;
EPA Reg. No. 59639-35)

Table 2.	   Physicochemical Properties of Fenpropathrin.

Parameter	Value	Reference

Melting point/range	45-50ºC (113-122ºF)	DP# 315918, W. Cutchin,
9/20/05

pH	4-5 (1% emulsion)

	Density g/cm3	1.103

	Water solubility (25ºC)	0.33 ppm

	Solvent solubility (mg/L at 25ºC)	Xylene, cyclohexanone:  1000

Methanol:  337

	Vapor pressure at 25ºC	0.730 mPa

	Dissociation constant, pKa	NA

	Octanol/water partition coefficient, Log(KOW)	5.1

	UV/visible absorption spectrum	NA

	

860.1200  Directions for Use

The petitioners submitted undated draft labels for the 2.4 lb/gal EC
formulation (Danitol® 2.4 EC Spray; EPA Reg. No. 59639-35).  A summary
of the proposed crop use patterns, sorted by petition, is listed in
Table 3.

Table 3.   Summary of Directions for Use of Fenpropathrin.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate 

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations

PP#4E6867

Stone Fruits:  apricots, cherries, nectarines, peaches, plums, and
prunes

Foliar spray

Ground	2.4 lb/gal EC

[59639-35]	0.2-0.4	2	0.8	3	Ground applications are to be made in 100-400
gal/A using airblast equipment with a minimum retreatment interval (RTI)
of 10 days.  The feeding or allowing of livestock to graze on cover
crops from treated orchards is prohibited.  For resistance management,
it is generally recommended that no more than two applications of the
2.4 lb/gal EC formulation be made per season.  Use non-pyrethroid
products at other timings to control pests.

Tree Nuts:  almonds, beechnuts, Brazil nuts, butternuts, cashews,
chestnuts, chinquapin, filberts (hazelnuts), hickory nuts, macadamia
nuts, pecans, pistachios, and walnuts

Foliar spray

Ground	2.4 lb/gal EC

[59639-35]	0.2-0.4	2	0.8	3	Ground applications are to be made in 50-400
gal/A using airblast equipment with a minimum RTI of 10 days.  The
feeding or allowing of livestock to graze on cover crops from treated
orchards is prohibited.  For resistance management, it is generally
recommended that no more than two applications of the 2.4 lb/gal EC
formulation be made per season.  Use non-pyrethroid products at other
timings to control pests.

PP#6E7066

Barley

Foliar spray

Ground	2.4 lb/gal EC

[59639-35]	0.2	1	0.2	14	Make a single ground application in the pre-boot
stage in a minimum of 5 gal/A.  For resistance management, it is
generally recommended that no more than one application of the 2.4
lb/gal EC formulation be made per season.  Use non-pyrethroid products
at other timings to control pests.

Tropical and sub tropical fruits (inedible peel) including but not
limited to avocado, canistel, mango, papaya, sapodilla, black sapote,
mamey sapote, star apple

Foliar spray

Ground	2.4 lb/gal EC

[59639-35]	0.3-0.4	2

(implied)	0.8	1	Ground applications are to be made in 100 gal/A with a
minimum RTI of 14 days.  For resistance management, it is generally
recommended that no more than one application (avocado) or two
applications (other crops) of the 2.4 lb/gal EC formulation be made per
season.  Use non-pyrethroid products at other timings to control pests.

PP#7E7298

Caneberries:  blackberry (including bingleberries, boysenberries,
dewberries, lowberries, marionberries, olallieberries, youngberries);
loganberries; and raspberries (black and red)

Foliar spray

Ground or aerial	2.4 lb/gal EC

[59639-35]	0.2-0.3	2	0.6	3	Applications are to be made in ≥20 gal/A
using ground equipment or 3-10 gal/A using aerial equipment with a
minimum RTI of 14 days.  For resistance management, it is generally
recommended that no more than two applications of the 2.4 lb/gal EC
formulation be made per season.  Use non-pyrethroid products at other
timings to control pests.  

Olive

Foliar spray

Ground	2.4 lb/gal EC

[59639-35]	0.2-0.3	Not specified	0.8	7	Ground applications are to be
made in ≥100 gal/A with a minimum RTI of 14 days.  

The following general use directions are listed on the draft labels for
Danitol® 2.4 EC Spray:  Application as an ultra low volume (ULV) spray
or through any type of irrigation system is prohibited.  There are no
restrictions on rotational crops listed on the proposed labels.  A 24
hour reentry interval (REI) is specified.

Conclusions.  The submitted use directions are sufficient to allow
evaluation of the submitted residue data relative to the proposed use. 
However, label revisions are required to reflect the appropriate
preharvest intervals for barley commodities.  Based on the submitted
field trial data, the label for Danitol® should be amended to specify
PHIs of 15 days for barley hay and 45 days for barley grain and straw.

860.1300 Nature of the Residue - Plants

DP#s 181992, 181994, 181996, 182011, 182014, and 182023, 11/4/92, M.
Bradley

PP4G03107, 10/23/84, R. Loranger and PP2F4144/FAP2H5648, 5/2/95, R. Cook

PP3F4186/FAP3H5661, 8/9/95, R. Cook

The nature of the residue in plants is adequately understood based on
metabolism studies conducted on apple, cotton, pinto beans, and
tomatoes.  The residue of concern is the parent compound fenpropathrin.

In the apple and pinto bean studies, the parent compound was found to be
the major residue; the remaining residues were characterized but not
identified.  The apple metabolism study was deemed fully adequate
because the majority of the residue was the parent compound.  The cotton
temporary tolerances were established with an expiration date because
the petitioner had indicated that a new cotton metabolism study would be
conducted to elucidate the nature of radioactive residues in cotton
commodities.  In both recent plant metabolism studies on cotton and
tomatoes, it has been concluded that the residue of concern is the
parent compound fenpropathrin per se.

860.1300 Nature of the Residue - Livestock

PP7F3485/7H5527, 9/11/87, M. Bradley

Metabolism studies with goats and poultry dosed with radiolabeled
fenpropathrin were previously submitted and reviewed.  The majority of
the residue in muscle, fat, milk, and eggs was found to be the parent
compound, fenpropathrin.  The residues in kidney and liver consisted
mainly of various metabolites.  HED previously stated that the livestock
metabolites, with the possible exception of TMPA lactone, have also been
identified in rat metabolism studies and their contributions to the
overall toxicity of fenpropathrin have been considered (memo, J. Whalen,
9/16/89).  For the apple and pear tolerances, the levels of the
metabolites in livestock were low enough not to be included in the
tolerance expression.

860.1340 Residue Analytical Methods

PP#7F3485/FAP#7H5527, 10/24/88, M. Bradley

  SEQ CHAPTER \h \r 1 An enforcement method is available for the
analysis of fenpropathrin in plants.  This method, Residue Method Number
RM-22-4 (11/1/89, revised 5/3/93) is entitled “Determination of
Fenpropathrin in Crops.”  It consolidates the procedure for high
moisture crops (RM-22-2) with that for oil crops (RM-22-3) and adds the
procedures for processed oil and soapstock.  Residues in crops are
extracted with acetone/hexane, partitioned into hexane, cleaned up by
silica gel and C18 Sep Pak chromatography, and measured by GC equipped
with an electron capture detector (ECD).  The LOD of this method is 0.01
ppm.  An EPA trial of this method for the determination of fenpropathrin
residues in apples has been successfully conducted.

Method RM-22A-1 determines fenpropathrin residues in animal tissues,
milk, and eggs.  The method is the same as RM-22-2 and RM-22-4 for high
moisture crops with the addition of a hexane/acetonitrile partition step
for fat extracts only.  An EPA trial of this method for the
determination of fenpropathrin residues in meat and milk has been
successfully conducted.  The lowest limit of method validation (LLMV)
was 0.05 ppm in milk and 0.5 ppm in fat and meat.

Samples from the current field trials and processing study were analyzed
for residues of fenpropathrin using a slightly modified version of
enforcement method RM-22-4.  Several minor modifications were made to
the original method, e.g., extraction and partitioning procedures were
scaled by half, and solvents utilized in the silica gel and C18 Sep Pac
cleanup steps were reduced.  Quantitation was performed using a gas
chromatograph equipped with:  (i) a nitrogen/ phosphorus detector (NPD)
for almond and pecan; (ii) a mass selective detector in the selected
ion-monitoring mode (GC/MS-SIM) for barley matrices; and (iii) an
electron capture detector for avocado and stone fruits.  The LLMV was
0.05 ppm for avocadoes.  The LLMV was 0.02 ppm for cherries, peaches,
fresh plums, dry plums, and barley grain, straw, and hay.  The method
was adequately validated in conjunction with analysis of samples
collected from the field trials.

860.1360 Multiresidue Methods

DP# 222174, 10/23/97, L. Cheng

  SEQ CHAPTER \h \r 1 Recovery of fenpropathrin was tested through FDA
multiresidue methods, and fenpropathrin was found to be completely
recovered by the PAM I Section 302 Method (Luke Method).

860.1380 Storage Stability

  SEQ CHAPTER \h \r 1 PP#6F4648, DP# 222174, 10/23/97, L. Cheng

  SEQ CHAPTER \h \r 1 PP#4F4327/FAP#4H5690, DP#s 200755 and 200765,
11/21/95, R. Cook

DER Reference List	46814801.der.doc

46814802.der.doc

47295501.de1.doc

47295501.de2.doc

47295502.der.doc

Previously submitted storage stability data have demonstrated that
fortified residues of fenpropathrin are reasonably stable under frozen
storage conditions for up to 4 months in peanut presscake; 6 months in
melons and cabbage; 9 months in broccoli; 11 months in orange oil and
dried peel (pulp); 12 months in apples, grapes, oranges, pears, and
peanut nutmeat; and 14 months in grape juice.  The data also indicate
that weathered residues of fenpropathrin are stable during frozen
storage for ~5 months in peanut oil, 13 months in peanut vines, and 15
months in peanut hulls and hay.

Storage stability studies conducted concurrently with crop field trial
studies indicate that residues of fenpropathrin are stable during frozen
storage for up to 203 days in olive oil, 209 days in olives, 217 days in
raspberries, 425 days in avocadoes, 540 days in barley straw, 542 days
in barley grain, and 575 days in barley hay.  The studies conducted by
IR-4 did not include zero-day data.  For this reason, these data should
be considered marginally acceptable.  According to OPPTS
860.1380(d)(6)(i), storage stability studies should always include a
zero-day sampling interval to establish the residue levels present at
the time samples are placed into storage.

The storage durations and conditions of samples from the crop field
trials submitted to support this petition are presented in Table 4.

Table 4.   Summary of Sample Storage Conditions and Durations.

Matrix 	Storage Temperature (°C)	Actual Storage Duration (days)
Interval of Demonstrated Storage Stability (days)

Stone Fruit:  Cherry (MRID 46385303), Peach (MRID 46385304), and Plum
(MRID 46386305, 46611001) 

Cherry, fruit	-20	247	365

Peach, fruit	-20	204

	Fresh plum, fruit	-20	176

	Dry plum	-20	197

	Tree Nut:  Almond (MRID 46385302) and Pecan (MRID 46385306)

Almond	<-20	217	365

Pecan	<-20	108

	Avocado	-20	406	425

Barley, grain	<-20	576	542

Barley, hay	<-20	579	575

Barley, straw	<-20	561	540

Caneberry	<-20	105-209	217

Olive

(field trial RAC)	<-20	163-201	209

Olive

(processing RAC)	<-20	174

	Olive oil	<-20	169-176	203

Conclusions.  There are adequate storage stability data to support the
integrity of samples collected from the field and processing studies. 
There are no corrections that need to be applied, as fenpropathrin
residues were found to be relatively stable under frozen storage
conditions in a wide range of plant commodities.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses that are relevant to this guideline topic.

860.1460 Food Handling

There are no proposed uses that are relevant to this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

D200755, R. Cook, 11/21/95

PP#7F3485/7H5527, M. Bradley, 9/11/87

  SEQ CHAPTER \h \r 1 Tolerances for residues of fenpropathrin per se in
livestock commodities are listed in 40 CFR §180.466(a).  The
established tolerances for animal commodities are 0.05 ppm (egg and fat,
meat, and meat byproducts of poultry), 0.1 ppm (meat and meat byproducts
of cattle, goat, hog, horse, and sheep), 1.0 ppm (fat of cattle, goat,
hog, horse, and sheep), and 2.0 ppm (milk fat reflecting 0.08 ppm in
whole milk).

Livestock dietary burdens

The livestock feedstuffs associated with the current petitions include
almond hulls and barley grain, hay, and straw.  Feedstuffs associated
with already registered crops include dried citrus pulp, cotton
undelinted seed, cotton gin byproducts, cotton meal, cotton hulls,
peanut meal, peanut hay, and wet apple pomace.  The dietary burdens of
fenpropathrin to livestock are calculated in Table 5, and the
calculations made reflect the most recent guidance from HED concerning
revisions of feedstuff percentages in Table 1 and constructing maximum
reasonably balanced livestock diets (MRBDs).  The dietary burdens are
0.49 ppm for beef cattle, 3.1 ppm for dairy cattle, 0.16 ppm for swine,
and 0.23 ppm for poultry.

Table 5.   Calculation of Dietary Burdens of Fenpropathrin Residues to
Livestock.

Feedstuff	Type1	% Dry Matter2	% Diet2	Recommended Tolerance (ppm)
Dietary Contribution (ppm)3

Beef Cattle

Barley hay	R	88	15	2.5	0.426

Barley grain	CC	88	25	0.04	0.011

Untreated	CC 	--	55	--	---

Cottonseed	PC	88	5	1.00	0.05

TOTAL BURDEN	--	--	100	--	0.49

Dairy Cattle

Peanut hay	R	85	10	20	2.35

Barley hay	R	88	20	2.5	0.59

Untreated	R	--	15	--	---

Barley grain	CC	88	45	0.04	0.02

Cottonseed	PC	88	10	1.00	0.11

TOTAL BURDEN	--	--	100	--	3.1

Poultry

Barley grain	CC	88	70	0.04	0.028

Untreated	CC	N/A4	5	N/A4	--

Cotton meal	PC	89	20	1.00	0.200

Peanut meal	PC	85	5	0.01	0.0005

TOTAL BURDEN	--	--	100	--	0.23

Swine

Barley grain	CC	88	20	0.04	0.008

Untreated	CC	N/A4	60	N/A4	--

Cotton meal	PC	89	15	1.00	0.15

TOTAL BURDEN	--	--	100	--	0.16

1  R:  Roughage; CC:  Carbohydrate concentrate; PC:  Protein
concentrate.

2  OPPTS 860.1000 Table 1 Feedstuffs (June 2008).  

3  Contribution = ([tolerance /% DM] X % diet) for beef and dairy
cattle; contribution = ([tolerance] X % diet) for poultry and swine. 

4  N/A:  Not applicable.  Tolerances/uses of fenpropathrin have not been
registered or proposed for this feedstuff.

The maximum theoretical dietary burden of fenpropathrin was previously
calculated to be 61.0 ppm for beef cattle, 41.6 ppm for dairy cattle,
and 0.0025 ppm for poultry (DP# 200755 and 2000765, 11/21/95, R. Cook).

Dairy Cattle Feeding Study

  SEQ CHAPTER \h \r 1 A dairy cattle feeding study (MRID 40024616) was
reviewed as part of the evaluation of tolerance petition 7F03485 (M.
Bradley, 9/11/1987).  Cattle were fed 25, 75, and 250 ppm fenpropathrin
in the daily diet for 28 consecutive days.  The results are summarized
in Table 6.

Table 6.   Maximum Residues in Dairy Cattle Commodities Following Oral
Administration of Fenpropathrin.

Matrix	Dosing Group	Maximum Fenpropathrin Residues (ppm)

Milk	25 ppm	0.06

	75 ppm	0.35

	250 ppm	0.46

Milk, pasteurized	250 ppm	0.25

Milk fat	250 ppm	3.2-4.2

Muscle	25 ppm	0.04

	75 ppm	0.12

	250 ppm	0.33

Kidney	25 ppm	0.05

	75 ppm	0.06

	250 ppm	0.2

Liver	25 ppm	<0.01

	75 ppm	<0.01

	250 ppm	0.01

Fat	25 ppm	0.44

	75 ppm	1.7

	250 ppm	4.1

Expected secondary residues in meat and milk

To reassess the tolerances for residues of fenpropathrin per se in milk
and tissues, the anticipated secondary residues in cattle matrices were
estimated using tissue to feed ratios calculated from the maximum
residues of fenpropathrin observed at the dose level closest to the MRBD
dietary burden in the dairy cattle feeding study.  These tissue to feed
ratios are presented in Table 7.  The transfer coefficient for each
matrix was then used to calculate the expected secondary residues by
multiplying the transfer coefficient by the calculated dietary burden. 
The expected residues of fenpropathrin per se and the recommended
tolerances based on expected residues are presented in Table 8.

Table 7.    Tissue to Feed Ratios in Dairy Cattle Milk and Tissues.

Matrix	Maximum Residue of Fenpropathrin (ppm)	Feeding Level

(ppm)	Tissue to Feed Ratio1

Milk	0.06	25	0.0024

Milk fat	4.2	250	0.0168

Muscle	0.04	25	0.0016

Kidney	0.05	25	0.0020

Liver	<0.01	25	0.0004

Fat	0.44	25	0.0176

1  Calculated from the maximum residues observed at the dose level
closest to the MRBD divided by the dose level.

Table 8.    Expected Secondary Residues of Fenpropathrin in Meat and
Milk.

Matrix	Dietary Burden

(ppm)	Secondary Residues 1

(ppm)	Recommended Tolerance

(ppm)

Dairy Cattle

Milk	3.1	0.00744	0.01

Milk fat	3.1	0.05208	0.05

Muscle	3.1	0.00496	0.01

Kidney	3.1	0.0062	0.01

Liver	3.1	0.00124	Not required

Fat	3.1	0.05456	0.05

Swine

Muscle	0.16	0.000256	Not required

Kidney	0.16	0.00032	Not required

Liver	0.16	0.000064	Not required

Fat	0.16	0.002816	Not required

1  Calculated from dietary burden x transfer coefficient from Table 7.

Conclusions.  Based on the dietary exposure levels and the residue data
from an available ruminant feeding study, the existing fenpropathrin
tolerances have been reassessed.  The feeding study data indicate that
the established tolerances for milk and ruminant tissues should be
lowered as shown in Table 8.  Based on the tissue to feed ratios for
livestock tissues and the relatively low dietary burden for swine of
0.16 ppm for fenpropathrin, tolerances for hogs are no longer needed.

Poultry Feeding Study

  SEQ CHAPTER \h \r 1 A poultry feeding study (MRID 40024617) was
reviewed as part of the evaluation of tolerance petition yF03485 (M
Bradley, 9/11/1987).  Laying hens were fed 2.5, 7.5, and 25 ppm
fenpropathrin in the daily diet for 28 consecutive days.  These feeding
levels are 10.9x, 32.8x, and 109x, respectively, the recalculated
dietary burden of 0.2285 ppm for poultry (see Table 5).  Eggs from the
two lower feeding levels bore nondetectable (<0.01 ppm) residues of the
parent compound.  Eggs from the 25-ppm feeding level had residues of
0.01-0.02 ppm parent from day 7 through 28.  Muscle, gizzard, and liver
had no detectable residues of parent compound from the three feeding
levels.  Residues of parent in fat were 0.02 ppm, 0.05-0.06 ppm, and
0.12-0.16 ppm at the low-, mid-, and high-dose feeding levels,
respectively.  

Conclusions:  Based on the dietary exposure levels and the residue data
from an available poultry feeding study, the existing fenpropathrin
tolerances of 0.05 ppm for egg, fat, meat, and meat byproducts of
poultry are adequate to support the proposed uses on barley.

860.1500 Crop Field Trials

Field Trial Data Submitted Under PP#4E6867

Stone Fruits

DER Reference List	46385303.der.doc (Cherry)

			46385304.der.doc (Peach)

			46385305.de1.doc (Plum)

In support of the requested uses on stone fruits, Valent U.S.A.
submitted magnitude of the residue studies for cherries (MRID 46385303),
peaches (MRID 46385304), and plums (MRID 46385305), the representative
crops of the Stone Fruits Crop Group.  The results from these field
trials are discussed below and summarized in Table 9.

Cherry:  Six cherry trials were conducted in the United States in EPA
Growing Zones 1 (NY and PA; 2 trials), 5 (MI; 1 trial), 9 (CO; 1 trial),
10 (CA; 1 trial), and 11 (WA; 1 trial) during the 2003 growing season. 
The cherry trials included 3 sweet and 3 tart cherry varieties.  

The test product, DANITOL 2.4 EC, containing 30.9% of fenpropathrin as
the active ingredient, was applied twice at each test location at the
rate of 0.399 lb ai/A/application at a 10-day interval.  Cherries were
harvested 3-4 days after the second application.

Residues of fenpropathrin were quantified using a slightly modified
version of Valent U.S.A. Corporation Residue Method RM-22-4,
Determination of Fenpropathrin in Crops.  The samples were extracted
with acetone/hexane, cleaned up by silica gel and C18 Sep Pak®
chromatography and measured by gas chromatography equipped with an
electron capture detector.  The method is adequate for data collection.

The residues of fenpropathrin on cherry samples treated at this rate
ranged from 1.43 to 3.53 ppm.  At two sites, cherries were treated at
0.800 lb ai/A/application.  Fenpropathrin residues on cherry samples
increased by 40 to 150% at this higher application rate.

At two other sites cherry samples were collected at 1, 3, 7, and 10 days
after the last application in order to observe residue decline.  The
results demonstrate an overall decrease in residues with estimated
half-lives on the order of 19 and 27 days.

The maximum storage duration of treated cherry samples from harvest to
analysis was 247 days.  One-year storage stability studies were not
performed with cherries.  Instead, surrogate studies conducted with
apples, grapes, oranges, pears, and melon were referenced to support the
storage stability of fenpropathrin in/on cherries.  These data indicate
that under frozen storage conditions, fortified residues of
fenpropathrin would be relatively stable in/on cherries for up to 247
days.

Peach:  Ten peach trials were conducted in the United States in EPA
Growing Zones 1 (PA; 1 trial), 2 (AL, SC, and GA; 4 trials), 5 (MI; 1
trial), 6 (TX; 1 trial), and 10 (CA; 3 trials) during the 2003 growing
season.  All field trial sites consisted of one untreated control plot
and one treated plot. 

The test product, DANITOL 2.4 EC, containing 30.9% of fenpropathrin as
the active ingredient, was applied twice at each test location at the
rate of 0.399 lb ai/A/application with a 10-day interval.  Peaches were
harvested 3-4 days after the last application.

Residues of fenpropathrin were quantified using a slightly modified
version of Valent U.S.A. Corporation Residue Method RM-22-4,
Determination of Fenpropathrin in Crops.  Residues in samples were
extracted with acetone/hexane, cleaned up by silica gel and C18 Sep
Pak® chromatography, and analyzed by gas chromatography equipped with
an electron capture detector.  The method is adequate for data
collection.

The residues of fenpropathrin on peach samples treated at this rate
ranged from 0.39 to 1.1 ppm.  At two sites, peaches were also treated at
a total seasonal rate of 1.6 lb a.i./A.  Average fenpropathrin residues
increased with this higher application rate.

At another site a decline study was conducted, where peach samples were
collected at 1, 4, 7, and 10 days after the last application.  The
results demonstrate an overall decrease in fenpropathrin residues with
an estimated half-life on the order of 12-14 days.

The maximum storage duration of treated peach samples from harvest to
analysis was 204 days.  The storage duration and conditions are
supported by storage stability studies conducted with apples, grapes,
oranges, pears, and melons.

  

Plum:  Six plum trials were conducted in the United States in EPA
Growing Zones 5 (MI; 1 trial), 10 (CA; 4 trials), and 12 (OR; 1 trial)
during the 2003 growing season.  All field trial sites consisted of one
untreated control plot and one treated plot. 

The test product DANITOL 2.4 EC, containing 30.9% of fenpropathrin  as
the active ingredient, was applied at each test location at the rate of
0.399 lb ai/A/application in two applications at a 10-day interval. 
Plums were harvested 3-4 days after the last application.  

Residues of fenpropathrin were quantified using a slightly modified
version of Valent USA Corporation Residue Method RM-22-4, Determination
of Fenpropathrin in Crops.  The residues were extracted with
acetone/hexane, cleaned up by silica gel and C18 Sep Pak®
chromatography and quantitated by gas chromatography equipped with an
electron capture detector.  The method is adequate for data collection.

The residues of fenpropathrin on plum samples treated at this rate
ranged from of 0.18 to 0.58 ppm.  At one site, treatments were made at a
total rate of 1.6 lb a.i./A.  The residues of fenpropathrin on plum
samples increased with this higher application rate.

At another site a decline study was conducted, where plum samples were
collected at 1, 3, 7, and 10 days after the last application.  The
results demonstrate only a slight degradation of fenpropathrin residues
with an estimated half-life on the order of 36 days.

The maximum storage duration of treated plum samples from harvest to
analysis was 176 days.  The storage duration and conditions are
supported by storage stability studies conducted with apples, grapes,
oranges, pears, and melons.

Table 9.   Summary of Residue Data from Stone Fruit Field Trials with
Fenpropathrin. 

Commodity	Total Applic. Rate (lb ai/A)	PHI (days)	Fenpropathrin Residue
(ppm)

	n	Min.	Max.	HAFT1	Median	Mean	Std. 

Dev.

Proposed use pattern:  Two foliar sprays at 0.2-0.4 lb ai/A/application
for a seasonal rate of 0.8 lb ai/A with a 3-day PHI.

Cherry, fruit	0.769-0.833	3	12	1.43	3.53	3.38	1.90	2.22	0.84

Peach, fruit	0.777-0.856	3-4 	20	0.39	1.11	1.03	0.71	0.74	0.19

Plum, fruit	0.781-0.813	3-4	11	0.18	0.58	0.55	0.24	0.30	0.13

1  HAFT = Highest Average Field Trial.

Conclusions.  The submitted residue data for cherries, peaches, and
plums, which are the representative commodities of the Stone Fruits Crop
Group (Group 12), are adequate to fulfill data requirements.  The number
and location of crop field trials are accordance with OPPTS Guideline
860.1500.  The trials reflect the proposed use pattern.

The residue data for cherries, peaches, and plums were entered into the
Agency’s tolerance spreadsheet as specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP to determine
appropriate tolerance levels; see Appendix I.  The tolerance spreadsheet
recommends individual tolerances of 5.0 ppm for cherry, 1.4 ppm for
peach, and 0.70 ppm for plum.  HED recommends in favor of the proposed
tolerance of 1.4 ppm for residues of fenpropathrin per se in/on Stone
Fruits except cherry (Crop Group 12).  The recommended tolerance for
both sweet and tart cherries is 5.0 ppm.  The petitioner needs to submit
a revised Section F that proposes these tolerance levels.

Tree Nuts (including Pistachios)

DER Reference List	46385302.der.doc (Almond), 46385306.der.doc (Pecan)

Valent U.S.A. submitted magnitude of the residue studies for almond
(MRID 46385302) and pecan (MRID 46385306) in support of the requested
uses on tree nuts.  The results from these field trials are discussed
below and summarized in Table 10.

Almond:  Five almond trials were conducted in the United States in Zone
10 (CA) during the 2003 growing season.  In all of the trials, two
airblast applications of a 2.4 lb/gal emulsifiable concentrate (EC)
formulation (Danitol 2.4EC; 30.9% fenpropathrin) were made 10 days apart
at a rate of 0.40 lb ai/A/application (0.80 lb ai/A/season), with a
3-day pre-harvest interval (PHI).  At one trial site, two treatments of
Danitol 2.4EC at a 2x rate of 0.80 lb ai/A/application (1.60 lb
ai/A/season) with the same timing were also made.  In addition, almond
samples were collected 1, 3, 7 and 14 days after the final application
at one of the sites to generate residue decline data.  No adjuvants or
additives were added to the spray mixture for any of the above
applications.

Residues of fenpropathrin were quantified using a slightly modified
version of Valent U.S.A. Corporation Residue Method RM-22-4,
Determination of Fenpropathrin in Crops.  Almond hulls and nutmeat
samples were macerated, blended with acetonitrile (ACN)/hexane (1:2,
v:v) and sodium sulfate, filtered, and the filtrate was then partitioned
with hexane/water.  The aqueous layer was discarded, and the hexane
layer was concentrated, partitioned with two portions of ACN, and
evaporated to dryness.  After reconstituting the residue in hexane, the
sample was cleaned up on a silica gel column using ether/hexane (1:5,
v:v) as the eluant.  After evaporating to dryness, the samples were
dissolved in methanol and transferred to a solid-phase extraction (SPE)
cartridge for additional cleanup.  Quantitation was accomplished by gas
chromatography equipped with a nitrogen-phosphorus detector (GC/NPD). 
Samples of almond nutmeat were fortified at 0.02 and 0.10 ppm, and
samples of almond hulls were fortified at 0.02, 0.04, 0.50, 4.0 and 7.5
ppm for concurrent recovery studies.

The lowest level of method validation (LLMV) and limit of quantitation
(LOQ) were not reported.  The limit of detection (LOD) for Method
RM-22-4 was reported to be 0.01 ppm, although the methodology by which
this value was determined was not described.  The mean concurrent
recovery of fenpropathrin for hulls at the lowest fortification level
(0.02 ppm) was 114% with a standard deviation (sd) of 1.4% (n = 2), and
for nutmeat, 103% with a sd of 14% (n = 3).  The method is adequate for
data collection.

Almond was harvested 3 days after the final application.  Trial results
show that all fenpropathrin residues were near or below the LOD (≤0.01
ppm) in/on almond nutmeat.  In one nutmeat trial (Wasco, CA),
fenpropathrin residues of 0.02 ppm and 0.03 ppm were found.  In another
trial (Glenn, CA), Danitol 2.4EC was applied at a 2x rate, resulting in
a mean residue of 0.02 ppm in/on nutmeat, and 7.3 ppm in/on almond
hulls.  Observed fenpropathrin residues in/on almond hulls from the 1x
trials ranged from 2.4-4.3 ppm.  At one trial site (Kerman, CA) samples
were collected at 1, 3, 7, and 14 days for a residue decline study, but
all nutmeat residues were below the LOD (<0.01 ppm), and consequently no
decline data were reported.

Almond nutmeat and hull samples were stored frozen for a maximum of 217
days at ≤-20°C.  Storage stability studies were not performed with
almond.  Instead, surrogate studies conducted with apples, grapes,
oranges, pears, and peanut and peanut shells were referenced to support
the storage stability of fenpropathrin in/on almond nutmeat and hulls. 
Results of the stability studies with the surrogate commodities suggest
that fenpropathrin residues should be stable for up to 217 days in/on
almond commodities. 

Pecan:  Five pecan trials were conducted in the United States in EPA
Growing Zones 2 (GA and SC; 1 trial each), 4 (AR; 1 trial), 6 (TX; 1
trial), and 8 (TX; 1 trial) during the 2003 growing season.  In all of
the trials, two airblast applications of a 2.4 lb/gal emulsifiable
concentrate (EC) formulation (Danitol 2.4EC; 30.9% fenpropathrin) were
made 10 days apart at a rate of 0.40 lb ai/A/application (0.80 lb
ai/A/season), with a 3-day pre-harvest interval (PHI).  At one trial
site, two treatments of Danitol 2.4EC at a 2x rate of 0.80 lb
ai/A/application (1.60 lb ai/A/season) with the same timing were also
made.  In addition, pecan samples were collected 1, 3, 7, and 14 days
after the final application at one of the sites to generate residue
decline data.  No adjuvants or additives were added to the spray mixture
for any of the above applications.

Residues of fenpropathrin were quantified using a slightly modified
version of Valent U.S.A. Corporation Residue Method RM-22-4,
Determination of Fenpropathrin in Crops.  Pecan nutmeat samples were
macerated, blended with acetonitrile (ACN)/hexane (1:2, v:v) and sodium
sulfate, filtered, and the filtrate was then partitioned with
hexane/water.  The aqueous layer was discarded, and the hexane layer was
concentrated, partitioned with two portions of ACN, and evaporated to
dryness.  After reconstituting the residue in hexane, the sample was
cleaned up on a silica gel column using ether/hexane (1:5, v:v) as the
eluant.  After evaporating to dryness, the samples were dissolved in
methanol, and transferred to a solid-phase extraction (SPE) cartridge
for additional cleanup.  Quantitation was accomplished by a gas
chromatograph equipped with a nitrogen-phosphorus detector (GC/NPD). 
Samples of pecan nutmeat were fortified at 0.02 and 0.10 ppm for
concurrent recovery studies.

The lowest level of method validation (LLMV) and limit of quantitation
(LOQ) were not reported.  The limit of detection (LOD) for Method
RM-22-4 was reported to be 0.01 ppm, although the methodology by which
this value was determined was not described.  The mean concurrent
recovery of fenpropathrin at the lowest fortification level (0.02 ppm)
was 78% with a standard deviation (sd) of 9.4% (n = 3).  The mean
overall concurrent recovery of fenpropathrin was 82% with sd of 7.6% (n
= 6).  The method is adequate for data collection.

maximum of 108 days at ≤-20°C.  Storage stability studies were not
performed with pecans.  Instead, surrogate studies conducted with
apples, grapes, oranges, pears, and peanuts and peanut shells were
referenced to support the storage stability of fenpropathrin in/on
pecans.  Results of the stability studies with the surrogate commodities
suggest that fenpropathrin residues should be stable for up to 108 days
in/on pecan nutmeat.

Table 10.   Summary of Residue Data from Tree Nut Field Trials with
Fenpropathrin. 

Commodity	Total Applic. Rate (lb ai/A)	PHI (days)	Fenpropathrin Residue
(ppm)

	n	Min.	Max.	HAFT1	Median	Mean	Std. 

Dev.

Proposed use pattern:  Two foliar sprays at 0.2-0.4 lb ai/A/application
for a seasonal rate of 0.8 lb ai/A with a 3-day PHI.

Almond hull	0.80	3	10	2.4	4.3	3.6	3.0	3.1	0.52

Almond nutmeat	0.80	3	10	<0.01	0.03	0.03	0.01	0.01	0.01

Pecan nutmeat	0.80	3	10	<0.01	0.05	0.05	0.02	0.02	0.01

1  HAFT = Highest Average Field Trial.

Pistachio

No residue data were submitted to support the proposed use on pistachio.
 Pistachio was listed by the petitioner in its proposed label with the
tree nuts.  According to the Reviewer’s Guide and Summary of HED
ChemSAC Approvals for Amending Crop Group/Subgroups [40 CFR 180.41] and
Commodity Definition [40 CFR 180.1(h)], dated 6/14/06, a separate
tolerance for pistachio should be listed in the appropriate section of
the CFR entry until the new crop group regulation for the Tree Nut Crop
Group 14 is published.

Conclusions.  The submitted residue data for almonds and pecans, which
are the representative commodities of the Tree Nut Crop Group (Group
14), are adequate to fulfill data requirements.  The number and location
of crop field trials are accordance with OPPTS Guideline 860.1500.  The
trials reflect the proposed use pattern.

The residue data for almond hulls and pecan nutmeat were entered into
the Agency’s tolerance spreadsheet as specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP to determine
appropriate tolerance levels; see Appendix I.  For almond hulls, the
tolerance spreadsheet recommends a tolerance of 4.5 ppm for residues of
fenpropathrin per se, which is slightly lower than the level proposed by
the petitioner.  For pecan nutmeat, the tolerance spreadsheet recommends
an individual tolerance of 0.10 ppm for residues of fenpropathrin per
se.  For almond nutmeat, the maximum residues observed from the 1x field
trials were 0.03 ppm.  These levels are not significantly different and
do not vary by a factor of 5x.  Based on the residue data for pecan
nutmeat, HED recommends in favor of a tolerance of 0.10 ppm for residues
of fenpropathrin per se in/on Crop Group 14.  This recommended tolerance
is identical to that proposed by the petitioner.  The available field
trial data for Tree Nut Crop Group 14 will be translated to pistachio.

Field Trial Data Submitted Under PP#6E7066

Avocado

DER Reference List	46814801.der.doc

Six supervised crop field trials were conducted in the United States in
EPA Growing Zones 3 (FL; 1 trial), 6 (TX; 1 trial), and 10 (CA; 4
trials) during the 2003 and 2004 growing seasons.  In all trials, two
foliar-directed spray applications of a 2.4 lb/gal emulsifiable
concentrate (EC) formulation (Danitol 2.4EC; 30.9% fenpropathrin) were
made 10-12 days apart at a rate of approximately 0.40 lb
ai/A/application (0.80 lb ai/A/season) at the fruit set or fruiting
stage.  At all the field trials, avocado was harvested one day after the
final application.  No adjuvants or additives were added to the spray
mixture for any of the above applications.

Residues of fenpropathrin were quantified using a slightly modified
version of Valent USA Corporation Residue Method RM-22-4, Determination
of Fenpropathrin in Crops.  Avocado samples were blended with
acetone/hexane and sodium sulfate, filtered, and then partitioned with
hexane/water.  The hexane was evaporated, and the aqueous layer was
cleaned up on a silica gel column, and eluted with ether/hexane (1:5). 
After evaporating to dryness, the samples were dissolved in methanol,
and transferred to a solid-phase extraction (SPE) cartridge for
additional cleanup.  Quantitation was accomplished by gas chromatography
using an electron capture detector (GC/ECD).  

Samples of avocado were fortified at 0.05, 1.0 and 10.0 ppm for method
validation, and at 0.05 and 1.0 ppm for concurrent recovery studies. 
The lowest level of method validation (LLMV) was reported as 0.05 ppm
for fenpropathrin in/on avocado.  The limit of detection (LOD) and the
limit of quantitation (LOQ) for the method were calculated to be 0.031
ppm and 0.093 ppm, respectively.  Concurrent recoveries of fenpropathrin
ranged from 66-119% in/on avocado.  Method validation recoveries of
fenpropathrin ranged from 86-107%.  The method is adequate for data
collection.

Avocado was stored frozen for a maximum of 406 days at <-20(C.  Frozen
storage stability samples were fortified at 1.0 ppm with fenpropathrin. 
Mean recoveries of fortified storage stability samples were 108% with a
standard deviation of 2.1%.

A summary of residue data from the avocado field trials is presented in
Table 11.  After two applications of fenpropathrin totaling 0.798-0.816
lb ai/A, residues ranged from 0.14 to 0.58 ppm in/on avocados (n=12
samples) harvested one day after the final application.  The average
residues in/on treated fruit samples were 0.39 ppm.  No residue decline
data were collected.

Table 11.   Summary of Residue Data from Avocado Field Trials with
Fenpropathrin.

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Fenpropathrin Residue  (ppm)

	n	Min.	Max.	HAFT	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Proposed use pattern:  Two foliar sprays at 0.3-0.4 lb ai/A/application
for a seasonal rate of 0.8 lb ai/A with a 1-day PHI.

Avocado	0.798-0.816	1	12	0.14	0.58	0.55	0.41	0.39	0.13

Conclusions.  The submitted residue data for avocado are adequate.  The
number and locations of crop field trials are in accordance with OPPTS
Guideline 860.1500.  The avocado trials were conducted according to the
proposed use rate and PHI.  The samples were analyzed using an adequate
analytical method, and the sample storage durations are supported by the
available storage stability data.  No residue decline data were
submitted, however.

The field trial data for avocado were entered into the Agency’s
tolerance spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP to determine an appropriate
tolerance level; see Appendix I.  The tolerance spreadsheet recommends
an individual tolerance of 1.0 ppm for avocado, which is identical to
the level proposed by the petitioner.

HED’s ChemSAC prepared a guidance document that discusses commodity
definitions and acceptable translations of field trial data for several
commodities.  This document is entitled:  “Reviewer’s Guide and
Summary of HED ChemSAC Approvals for Amending Commodity Definitions
[Crop Group/Subgroups [40 CFR 180.41] and Commodity Definition [40 CFR
180.1(h)]” (B. Schneider, 6/14/06).  The document states that the
commodity definition for avocado includes black sapote, canistel, mamey
sapote, mango, sapodilla, and star apple.  As a result, the available
data for avocado may be translated to support the proposed uses on these
additional commodities.

Barley

DER Reference List	46814802.der.doc

Twelve supervised crop field trials were conducted in the United States
in EPA Growing Zones 2 (MD; 1 trial), 5 (ND and SD; 5 trials), 7 (ND; 2
trials), 8 (CO; 1 trial), 10 (CA; 1 trial), and 11 (ID and WA; 2 trials)
during the 2003 and 2004 growing season.  In all trials, one foliar
application of Danitol 2.4EC (30.9% fenpropathrin) was made at a rate of
approximately 0.20 lb ai/A at the pre-boot timing stage.  At all the
field trials, hay samples were harvested 15-60 days after application
and grain and straw samples were harvested 45-96 days after application.
 Hay was sampled at a moisture content of approximately 10-20%.  No
adjuvants or additives were added to the spray mixture for any of the
above applications.

	

Residues of fenpropathrin were quantified using a slightly modified
version of the Valent USA Corporation Residue Method RM-22-4,
Determination of Fenpropathrin in Crops.  Hay, grain, and straw samples
are blended with acetone/hexane, filtered, and then partitioned with
hexane/water.  The hexane is evaporated, and the aqueous layer is
cleaned up on a silica gel column and eluted with ether:hexane (1:5). 
After evaporating to dryness, the samples are dissolved in methanol and
transferred to a SPD cartridge for additional cleanup.  Quantitation was
accomplished by gas chromatography using a mass selective detector in
the selected ion-monitoring mode (GC/MS-SIM).  Samples of barley grain
were fortified at 0.02 ppm and 0.20 ppm for method validation and at
0.02 ppm for concurrent recovery studies.  Samples of barley hay were
fortified at 0.02 ppm, 0.20, ppm and 2.0 ppm for method validation and
at 0.02 ppm, 0.20 ppm, 2.0 ppm, and 3.0 ppm for concurrent recovery
studies.  Samples of barley straw were fortified at 0.02 ppm and 0.20
ppm for method validation and at 0.02 ppm, 0.20 ppm, and 2.0 ppm for
concurrent recovery studies.

The lowest level of method validation (LLMV) was reported as 0.02 ppm
for fenpropathrin in/on barley hay, straw, and grain.  The limit of
detection (LOD) for the method was calculated to be 0.0089 ppm (grain),
0.0040 ppm (hay), and 0.0025 ppm (straw).  The limit of quantitation
(LOQ) was calculated to be 0.027 ppm (grain), 0.012 ppm (hay), and 0.007
ppm (straw).  Concurrent recoveries of fenpropathrin ranged from 76-122%
in/on barley hay, 66-98% in/on barley grain, and 85-100% in/on barley
straw, respectively.  Method validation recoveries of fenpropathrin
ranged from 81-114% in/on barley hay, 92-121% in/on barley grain, and
90-94% in/on barley straw, respectively.  The method is adequate for
data collection.

Barley grain and straw were harvested 45-96 days after the final
application.  Barley hay was harvested 15-60 days after the final
application.  All fenpropathrin residues in/on grain were below the
lowest level of method validation (<0.02 ppm) in all but one California
trial (CA58).  The total residues in the CA58 trial were 0.038 ppm and
0.024 ppm in grain samples harvested 96 days after application.  The
total residues of fenpropathrin in/on hay samples ranged from <LLMV
(0.02 ppm) to 2.05 ppm in hay samples harvested 15-60 days after
application.  The total residues of fenpropathrin ranged from <LLMV
(0.02 ppm) to 1.27 ppm in/on straw samples harvested 45-96 days after
application.  No residue decline data were collected.

Barley grain, hay, and straw samples were stored frozen for a maximum of
576, 579, and 561 days, respectively, at -20(C.  Frozen storage
stability samples were fortified at 0.20 ppm with fenpropathrin.  Mean
percent recoveries for the fortified storage stability samples (± the
standard deviation (S.D.)) were 97 ± 10.4% for fenpropathrin in/on
grain, 101 ± 3.8% for fenpropathrin in/on hay, and 112 ± 7.8% for
fenpropathrin in/on straw.  

A summary of residue data from the barley field trials is presented in
Table 12.  After a single foliar broadcast spray application of
fenpropathrin made at the pre-boot stage at 0.195-0.204 lb ai/A,
residues at a 15- to 60-day PHI were <0.02-2.05 ppm in/on hay.  Residues
at a 45- to 96-day PHI were <0.02-0.038 ppm in/on grain and <0.02-1.27
ppm in/on straw.  The average residues were 0.68 ppm for hay, 0.021 ppm
for grain, and 0.33 ppm for straw.

Table 12.   Summary of Residue Data from Barley Field Trials with
Fenpropathrin.

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Fenpropathrin Residue  (ppm)

	N	Min.	Max.	HAFT	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Proposed use pattern:  Single foliar spray application made at pre-boot
stage at 0.2 lb ai/A with a 14-day PHI.

Barley, hay	0.195-0.204	15-60	24	<0.020	2.05	1.93	0.50	0.68	0.58

Barley, grain

45-96	24	<0.020	0.038	0.031	0.02	0.021	0.004

Barley, straw

45-96	24	<0.020	1.27	1.03	0.18	0.33	0.35

Conclusions.  The submitted barley field trial data are acceptable and
reflect the proposed use pattern for barley, except that hay samples
were harvested at a 15- to 60-day PHI, and samples of straw and grain
were harvested at a 45- to 96-day PHI.  However, the petitioner simply
proposed a 14-day PHI for barley.  The number and locations of crop
field trials are in accordance with OPPTS Guideline 860.1500.  The
samples were analyzed using an adequate analytical method and the sample
storage durations are supported by the available storage stability data.
 However, no residue decline data were submitted.  A barley processing
study is required for HED to complete its review of this proposed use.

The field trial data for barley hay and straw were entered into the
Agency’s tolerance spreadsheet as specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP to determine
appropriate tolerance levels; see Appendix I.  The tolerance spreadsheet
recommends a tolerance of 2.5 ppm for barley hay, which is identical to
the level proposed by the petitioner.  The tolerance spreadsheet
recommends tolerances of 4.0 ppm for barley straw, which is slightly
lower than the petitioner’s proposed tolerance of 4.5 ppm for barley
straw.

The Agency’s tolerance spreadsheet was not used for barley grain, as
>90% of the treated samples bore residues below the LLMV (<0.02 ppm). 
HED recommends a tolerance of 0.04 ppm for barley grain based on the
maximum residue of 0.038 ppm observed in the field trials.  The
recommended tolerance of 0.04 ppm for barley grain is significantly
lower than the petitioner’s proposed tolerance of 0.30 ppm for barley
grain.  The petitioner may have miscalculated the tolerance based on a
maximum residue of 0.38 ppm, instead of 0.038 ppm.  The barley
tolerances are withheld pending the submission and subsequent review of
a barley processing study.

Field Trial Data Submitted Under PP#7E7298

Caneberry subgroup 13A

DER Reference List	47295501.der.doc (Caneberry)

Seven caneberry trials were conducted in EPA Growing Zones 2 (NC and NJ;
2 trials), 5 (MI; 1 trial), 10 (CA; 1 trial), and 12 (OR; 3 trials)
during the 2005 growing season.  Raspberry varieties were used in all
the field trials except for one Oregon trial that was conducted with a
variety of blackberry.  At each trial, two foliar directed spray
applications of a 2.4 lb/gal emulsifiable concentrate (EC) formulation
of fenpropathrin were made at 0.394-0.436 lb ai/A/application, with a 6-
to 8-day retreatment interval, for a total application rate of
0.795-0.860 lb ai/A.  Applications were made using ground equipment in
22-54 gal/A, without an adjuvant.  Mature caneberries were harvested two
or three days after the last application.

Samples of caneberry were analyzed for residues of fenpropathrin using a
GC/MS-SIM method, entitled “Working Method, Revision 0 (PR No.
08735/Fenpropathrin/Caneberry).”  This method is very similar to
Valent USA Corporation residue Method RM-22-4, “Determination of
Fenpropathrin in Crops.”  This method is adequate for data collection
based on acceptable method recoveries.  The lowest level of method
validation (LLMV) for this method was 0.02 ppm for fenpropathrin.  The
calculated limit of quantitation (LOQ) and limit of detection (LOD) for
fenpropathrin were 0.018 ppm and 0.006 ppm, respectively.

The maximum storage duration of treated caneberry samples from harvest
to analysis was 209 days (6.9 months).  The storage duration is
supported by adequate storage stability data which were generated
concurrently with the field trials.  SEQ CHAPTER \h \r 1   T  SEQ
CHAPTER \h \r 1 hese data indicate that under frozen storage conditions,
fortified residues of fenpropathrin were relatively stable in/on
raspberry for up to 217 days. 

A summary of residue data from the caneberry field trials is presented
in Table 13.  Maximum residues of fenpropathrin were 7.1 ppm in/on
caneberries harvested two or three days after the last of two foliar
directed spray applications of the 2.4 lb/gal EC formulation at total
seasonal rates of 0.795-0.860 lb ai/A.  No residue decline data were
submitted.



Table 13.   Summary of Residue Data from Caneberry Field Trials with
Fenpropathrin.

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Fenpropathrin Residue (ppm)

	n	Min.	Max.	HAFT	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Proposed use pattern:  Two foliar sprays at 0.2-0.3 lb ai/A/application
for a seasonal rate of 0.6 lb ai/A with a 3-day PHI.

Caneberries (raspberry and blackberry)	0.795-0.860	2-3	14	1.0	7.1	5.8
2.1	3.1	2.0

Conclusions:  The submitted residue data for caneberries, as represented
by raspberries blackberries, are adequate pending submission of
confirmatory residue decline data.  Confirmatory residue decline data
are required to determine the approximate half-life of the residues and
to confirm that residues are not higher at longer PHIs than that which
is proposed.  Although the locations of the field trials are not in
strict accordance with OPPTS Guideline 860.1500, the total number of
field trials is in accordance with the guideline.  The trials conducted
reflect an application rate of 0.795-0.860 lb ai/A (1.3-1.4x the maximum
proposed seasonal rate of 0.6 lb) and PHIs of 2-3 days.  Samples were
analyzed for residues of fenpropathrin using an adequate analytical
method, and sample storage durations are supported by adequate storage
stability data.

The field trial data for caneberries were entered into the Agency’s
tolerance spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP to determine an appropriate
tolerance level; see Appendix I.  The tolerance spreadsheet recommends
an individual tolerance of 12.0 ppm for caneberry.  HED recommends in
favor of a tolerance of 12.0 ppm for residues of fenpropathrin in/on
Subgroup 13A based on residue data from blackberry and raspberry.  This
tolerance level recommendation is identical to the level proposed by the
petitioner.

Olive

DER Reference List	47295502.de1.doc (Olive)

Three olive trials were conducted in Zone 10 (California) during the
2005 growing season.  At each trial, two foliar-directed spray
applications of a 2.4 lb/gal emulsifiable concentrate (EC) formulation
of fenpropathrin were made at 0.400-0.427 lb ai/A/application, with a
7-day retreatment interval (RTI), for a total rate of 0.801-0.847 lb
ai/A.  At one site, a second plot was treated with fenpropathrin at
rates totaling 4.149 lb ai/A (~5x nominal rate); fruits from this plot
were used in the processing study.  Applications were made using ground
equipment in 53-103 gal/A spray volumes, without an adjuvant.  Samples
of mature olives were harvested from each site 7-8 and 14-15 days after
the last application.

Samples of olive were analyzed for residues of fenpropathrin using a
GC/MS-SIM method, entitled “Determination of Fenpropathrin in Olive,
Revision 0.”  This method is very similar to Valent U.S.A. Corporation
residue Method RM-22-4, Determination of Fenpropathrin in Crops.  This
method is adequate for data collection based on acceptable method
recoveries.  The lowest level of method validation (LLMV) for this
method was 0.02 ppm for fenpropathrin.  The calculated limit of
quantitation (LOQ) and limit of detection (LOD) for fenpropathrin were
0.022 ppm and 0.007 ppm, respectively.

The maximum storage duration of olive samples from harvest to analysis
was 201 days (6.6 months).  SEQ CHAPTER \h \r 1   The storage duration
is supported by adequate storage stability data which were generated
concurrently with the field trials.  T  SEQ CHAPTER \h \r 1 hese data
indicate that, under frozen storage conditions, fortified residues of
fenpropathrin were relatively stable for up to 209 days in olive fruit
without pit, and support the storage durations of the olive samples from
the submitted field trials.

A summary of residue data from the olive field trials is presented in
Table 14.  Maximum residues of fenpropathrin were 3.7 and 2.3 ppm in/on
olives harvested 7-8 days and 14-15 days, respectively, following the
last of two foliar-directed spray applications of the 2.4 lb/gal EC
formulation at total seasonal rates of 0.801-0.847 lb ai/A.

Table 14.   Summary of Residue Data from Olive Field Trials with
Fenpropathrin.

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Fenpropathrin Residue  (ppm)

	n	Min.	Max.	HAFT	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Proposed use pattern:  Foliar sprays at 0.2-0.3 lb ai/A/application for
a seasonal rate of 0.8 lb ai/A with a 7-day PHI.

Olive fruit without pit	0.801-0.847	7-8	6	1.8	3.7	3.6	2.2	2.6	0.8

14-15	6	1.2	2.3	1.9	1.7	1.8	0.4

Conclusions.  The submitted residue data for olive are adequate.  The
number and locations of crop field trials are in accordance with OPPTS
Guideline 860.1500.  The olive trials were conducted according to the
proposed use rate and PHI.  The samples were analyzed using an adequate
analytical method, and sample storage durations are supported by the
concurrent storage stability data.

The field trial data for olive were entered into the Agency’s
tolerance spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP to determine an appropriate
tolerance level; see Appendix I.  The tolerance spreadsheet recommends a
tolerance of 5.0 ppm for olive which is identical to the level proposed
by the petitioner.

860.1520 Processed Food and Feed

The proposed uses of fenpropathrin on barley, olive, and plums require
processing data.  No processing data were submitted for barley.  The
results of the processing data submitted for olives and plums are
summarized in Table 15.

  SEQ CHAPTER \h \r 1 Table 15.   Summary of Processing Factors for
Fenpropathrin.

RAC	Processed Commodity	Processing Factor

Barley, grain	Pearled barley	Not available

	Flour

Bran

	Olive, whole fruit	Olive oil	1.07x

Plum, fresh	Plum, dry/prune	2.6x

Barley

Barley processing data were not submitted.  These data are required,
however, to support the proposed use of fenpropathrin on barley.  The
barley tolerances are withheld pending the submission and subsequent
review of a barley processing study.

Olive

DER Reference List	47295502.de2.doc (Olive)

The Interregional Research Project No. 4 (IR-4) submitted the results of
an olive processing study with fenpropathrin.  In one trial conducted in
California during the 2005 growing season, a 2.4 lb/gal emulsifiable
concentrate (EC) formulation of fenpropathrin was applied to olives as
two foliar-directed applications at 2.07-2.08 lb ai/A/application, with
a 7-day retreatment interval (RTI), for a total seasonal rate of 4.15 lb
ai/A (~5x the nominal field trial rate).  All applications were made in
103-104 gal/A spray volumes without an adjuvant.

Single control and treated samples of olives were harvested seven days
after the last application, and the olives were processed into oil using
simulated commercial procedures.  Samples of olive and olive oil were
stored frozen for 174 and 176 days, respectively, prior to analysis. 
The storage durations and conditions were supported by concurrent
storage stability data.

Samples of olive fruit and oil were analyzed for residues of
fenpropathrin using a GC/MS-SIM method entitled “Determination of
Fenpropathrin in Olive, Revision 0.”  This method is very similar to
Valent U.S.A. Corporation residue Method RM-22-4, “Determination of
Fenpropathrin in Crops.”  This method is adequate for data collection
based on acceptable method recoveries.  The LLMV for this method was
0.02 ppm for fenpropathrin.  The calculated LOQ and LOD for
fenpropathrin were 0.022 ppm and 0.007 ppm, respectively, in/on olive
fruit, and the calculated LOQ and LOD for fenpropathrin were 0.031 ppm
and 0.010 ppm, respectively, in olive oil.  

Following two foliar-directed applications of a 2.4 lb/gal EC
formulation at a total seasonal rate of 4.149 lb ai/A (~5x the nominal
field trial rate), residues of fenpropathrin were 14.63 ppm in the
sample of whole olives harvested at a 7-day pre-harvest interval (PHI),
and 15.60 ppm in processed olive oil.  The processing factor for
fenpropathrin in olive oil is therefore 1.07x.

The calculated processing factor for olive does not exceed the maximum
theoretical concentration factor of 108x (OPPTS 860.1520, Table 3).

Plum

DER Reference List	46611001.der.doc (Plum)

Valent U.S.A. Corporation submitted two plum processing studies in
support of the stone fruit tolerance petition.  The registrant reported
that the first plum processing study (MRID 46385305), was inadequate
because the fruit was not at the correct stage of ripeness when it was
processed and the study itself was not performed according to common
commercial practice (electronic communication, J. Smith to B. Madden,
7/17/2008).  Commercial fruit is steamed just prior to packaging.  This
step was not performed in the initial processing study.  As a result,
problems arose in preparing the dried fruit for analysis.  

In the second study (MRID 46611001), which the registrant felt was
adequate, the average fenpropathrin residues were 0.35 ppm and 0.22 ppm
in/on two batches of fresh plums (field and processing samples) treated
with the 2.4 lb/gal EC formulation at 1x.  When the RAC samples bearing
residues of 0.22 ppm were processed, the average residue was 0.58 ppm
(processing factor of 2.6x) in dried plums.  The observed processing
factor of 2.6x is less than the theoretical concentration factor of 3.4x
for prunes (based on loss of water; OPPTS 860.1520, Table 2).

Based on the results of the second study (2.6x processing factor) and
the HAFT (highest average field trial) residue of 0.55 ppm for fresh
plums (see 860.1500 DER for MRID 46385305), the expected residues of
fenpropathrin in dried plums resulting from the proposed use pattern on
stone fruits is 1.43 ppm which is almost identical to the recommended
tolerance of 1.4 ppm for stone fruit, group 12, except cherry.  HED
concludes that a tolerance need not be established for residues of
fenpropathrin in dried plums because the recommended crop group
tolerance for stone fruits will cover any expected residues in processed
or dried plums.

Adequate methodology was used for determination of fenpropathrin
residues and the available storage stability data support the storage
durations and conditions of the samples from both processing studies.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference
Standards

Analytical reference standards for fenpropathrin are currently available
at the EPA National Pesticide Standards Repository (electronic
communication, Dallas Wright, ACB, 8/21/2008).  However, the standard
for fenpropathrin will expire 12/4/2008.  The registrant must either
recertify the lot in the repository and send in an updated certificate
of analysis (COA), or submit new standards (different lot #) if the
previous lots will not be recertified.  If new COAs are being submitted,
they should be faxed to the repository at 410-305-2999.

If new standards are being submitted, they should be sent to the
Analytical Chemistry Lab, which is located at Fort Meade, to the
attention of Theresa Cole at the following address:

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not
used.)

860.1850 and 860.1900 Confined and Field Accumulation in Rotational
Crops

DP#s 188749 and 190693, 7/1/93, M. Bradley

Adequate confined and field accumulation studies in rotational crops
were previously submitted and have been reviewed by HED (Memo, D188749,
M. Bradley, 7/1/93).  In the confined rotational crop study, a single
application was made to the soil at 1.6 lb ai/A and carrots, lettuce,
and wheat were planted 30, 127, and 365 days following application.  HED
concluded that, with the exception of a soil metabolite which may have
occurred in lettuce and carrots from soil contamination, the same
metabolites were seen in the confined rotational crop study as in the
primary plant and livestock metabolism studies and rat metabolism
studies.  Levels of the metabolites TMPA and 3-PBA that were observed in
the study were insignificant compared to the levels of fenpropathrin per
se.

In the field rotational crop studies, cotton was treated with five
foliar applications of fenpropathrin at 0.3 lb ai/A/application.  The
cotton plants were then tilled under and carrots, lettuce, and wheat
were planted ~30, 120, and 365 days following the last application.  No
detectable residues of fenpropathrin were found in any of carrot,
lettuce, or wheat samples at any of the plantback intervals.  Based on
these studies, HED concluded that no rotational crop tolerances or
restrictions were required for the present uses of fenpropathrin.

860.1550 Proposed Tolerances

Fenpropathrin   SEQ CHAPTER \h \r 1 tolerances are established under 40
CFR §180.466 and are expressed in terms of the pesticide chemical
fenpropathrin (alpha-cyano-3-phenoxy-benzyl
2,2,3,3-tetramethylcyclopropanecarboxylate).  The nature of the residue
in plants and animals is understood.  The residue of concern in plants
and animals for tolerance expression is fenpropathrin per se.  The
tolerance expressions in the current petitions are expressed in term of
fenpropathrin per se.

The tolerance levels proposed by the petitioner along with HED’s
recommended tolerance levels are listed in Table 16.   SEQ CHAPTER \h \r
1  The petitioner needs to submit a revised section F reflecting the
revised tolerances and commodity definitions presented in Table 16.  The
Agency’s Guidance for Setting Pesticide Tolerances Based on Field
Trial Data was utilized for determining appropriate tolerance levels for
stone fruits, tree nuts, almond hulls, caneberries, avocados, olives,
barley hay and barley straw (see Appendix I).

The submitted residue data for cherries, peaches, and plums, which are
the representative commodities of Stone Fruits (Crop Group 12), are
adequate.  The tolerance spreadsheet recommends individual tolerances of
5.0 ppm for cherry, 1.4 ppm for peach, and 0.70 ppm for plum.  HED
recommends in favor of the proposed tolerance of 1.4 ppm for residues of
fenpropathrin per se in/on the Stone Fruits Crop Group, except cherry. 
The recommended tolerance for both sweet and tart cherries is 5.0 ppm. 
These recommendations are revised from the levels proposed by the
petitioner.

The submitted residue data for almond and pecan, which are the
representative commodities of Tree Nuts (Crop Group 14), are adequate. 
For almond hulls, the tolerance spreadsheet recommends a tolerance of
4.5 ppm for residues of fenpropathrin per se, which is slightly lower
than the level proposed by the petitioner.  For pecan nutmeat, the
tolerance spreadsheet recommends an individual tolerance of 0.10 ppm for
residues of fenpropathrin per se.  For almond nutmeat, the maximum
residues observed from the 1x field trials were 0.03 ppm.  These levels
are not significantly different and do not vary by a factor of 5x. 
Based on the residue data from pecan nutmeat, HED recommends a tolerance
of 0.10 ppm for residues of fenpropathrin per se in/on Crop Group 14. 
This recommendation is identical to the level proposed by the
petitioner.

HED recently concluded that pistachio will be added to the Tree Nuts
Crop Group (Group 14).  Until the regulations have been finalized in the
Federal Register, a separate tolerance is needed for pistachio, at the
same level as the tree nuts crop group tolerance.

The field trial data for avocado are adequate.  The tolerance
spreadsheet recommends an individual tolerance of 1.0 ppm for avocado
which is identical to the level proposed by the petitioner.

HED’s ChemSAC prepared a guidance document that discusses commodity
definitions and acceptable translations of field trial data for several
commodities.  This document is entitled:  “Reviewer’s Guide and
Summary of HED ChemSAC Approvals for Amending Commodity Definitions
[Crop Group/Subgroups [40 CFR 180.41] and Commodity Definition [40 CFR
180.1(h)]” (B. Schneider, 6/14/06).  The document states that the
commodity definition for avocado includes black sapote, canistel, mamey
sapote, mango, sapodilla, and star apple.  As a result, the available
data for avocado may be translated to support the proposed uses on these
additional commodities.

The submitted residue data for barley are not adequate to support the
establishment of a fenpropathrin tolerance for barley.  A barley
processing study is required for HED to complete its review of the
proposed use on barley.  The registrant should submit a revised label
that includes appropriate PHIs for hay, grain, and straw.  

The tolerance spreadsheet recommends a tolerance of 2.5 ppm for barley
hay which is identical to the level proposed by the petitioner.  The
tolerance spreadsheet recommends tolerances of 4.0 ppm for barley straw
which is slightly lower than the petitioner’s tolerance proposal of
4.5 ppm for barley straw.

The Agency’s tolerance spreadsheet was not used for barley grain, as
>90% of the treated samples bore residues below the LLMV (<0.02 ppm). 
HED recommends a tolerance of 0.04 ppm for barley grain based on the
maximum residue of 0.038 ppm observed from the field trials.  The
recommended tolerance of 0.04 ppm for barley grain is significantly
lower than the petitioner’s proposed tolerance of 0.30 ppm for barley
grain.  The petitioner may have miscalculated the tolerance based on a
maximum residue of 0.38 ppm, instead of 0.038 ppm.

Pending the submission of residue decline data, the submitted field
trial data for caneberries are adequate.  The tolerance spreadsheet
recommends a tolerance of 12.0 ppm for the Caneberry Subgroup (Subgroup
13-07A), which is identical to the level proposed by the petitioner. 
The Agency has finalized the revision to the existing Caneberry Subgroup
13A (Federal Register Vol. 72, No. 235, pages 69150-69158; 12/7/07) to
include the following commodities:  blackberry; loganberry; raspberry,
red and black; wild raspberry; cultivars, varieties, and/or hybrids of
these.  The final rule changes the subgroup name from “Caneberry
Subgroup 13A” to “Caneberry Subgroup 13-07A.”

The submitted residue data for olives are adequate.  The tolerance
spreadsheet recommends a tolerance of 5.0 ppm for residues of
fenpropathrin per se in/on olive which is identical to the level
proposed by the petitioner.

Acceptable processing studies have been submitted for olive and plum,
and the results suggest that a tolerance is not required for the
processed commodity olive oil, but will be required for dried
plum/prune.  A barley processing study remains outstanding to support
the proposed use on barley.

Established ruminant commodity tolerances were reassessed in this action
review.  As dietary burden calculations are now based on “reasonably
balanced diets” (RBDs), the established tolerances could be further
lowered or removed.  Based on the dietary exposure levels, the available
ruminant feeding study data indicate that decreased tolerances are
needed for:  (i) meat and meat byproducts of cattle, goat, horse, and
sheep, from 0.1 to 0.01 ppm; (ii) fat of cattle, goat, horse, and sheep,
from 1.0 to 0.05 ppm; and (iii) milk fat of dairy cattle, from 2.0 to
0.05 ppm.  The available data also indicate that tolerances for all hog
commodities are not needed; these tolerances should be removed.

The established tolerances for poultry commodities, at 0.05 ppm for
residues of fenpropathrin per se in egg, fat, meat, and meat byproducts
are adequate; no revision to these tolerances is needed as a result of
the requested amended uses.

Codex and Mexican MRLs are established for residues of fenpropathrin
(expressed as fenpropathrin per se for Codex and fenpropathrin for
Mexico) but no limits are listed for the crop commodities addressed in
this summary document.  No Canadian MRLs are established for
fenpropathrin.  An International Residue Limit Status form is included
in this Summary Document (see Attachment).

Table 16.   Tolerance Summary for Fenpropathrin.

Commodity	Established/Proposed Tolerance (ppm)	Recommended Tolerance
(ppm)	Comments; Correct Commodity Definition

Tolerances Proposed Under PP#4E6867

Stone Fruit, Crop Group 12 (except Cherry)	5.0	1.4	Fruit, stone, group
12

Cherry, sweet and tart	--	5.0	Cherry, sweet

Cherry, tart

Tolerance recommendation is based on >5x differences of maximum field
trial residues between cherry and remaining stone fruit representative
crops

Tree Nuts (including Pistachio), Crop Group 14	0.10 (nutmeats)	0.10	Nut,
tree, group 14

	5.0 (almond hulls)	4.5	Almond, hulls

Tolerance That Needs to be Proposed Under PP#4E6867

Pistachio	--	0.10	Tolerance recommendation is based on residue data
translated from the Nut, Tree, Crop Group 14.

Tolerances Proposed Under PP#6E7066

Avocado	1.0	1.0

	Black Sapote	1.0	1.0	Tolerance recommendations are based on residue
data translated from avocado and pending submission of confirmatory
residue decline data for avocado.

Canistel	1.0	1.0

	Mamey sapote	1.0	1.0

	Mango	1.0	1.0

	Papaya	1.0	1.0

	Sapodilla	1.0	1.0

	Star apple	1.0	1.0

	Barley, grain	0.30	Withheld	HED will complete its review of the
proposed barley use upon submission of a barley processing study.

Barley, hay	2.5	Withheld

	Barley, straw	4.5	Withheld

	Tolerances Proposed Under PP#7E7298

Caneberry subgroup 13A	--	12	Caneberry subgroup 13-07A

Olive	--	5.0

	Reassessment of Tolerances for Ruminant Commodities

Cattle, fat	1.0	0.05	The available data indicate that the tolerances may
be decreased.

Cattle, meat byproducts	0.1	0.01

	Cattle, meat	0.1	0.01

	Goat, fat	1.0	0.05	The available data indicate that the tolerances may
be decreased.

Goat, meat byproducts	0.1	0.01

	Goat, meat	0.1	0.01

	Hog, fat	1.0	Remove	The available data indicate that tolerances for hog
commodities are not needed.

Hog, meat byproducts	0.1	Remove

	Hog, meat	0.1	Remove

	Horse, fat	1.0	0.05	The available data indicate that the tolerances may
be decreased.

Horse, meat byproducts	0.1	0.01

	Horse, meat	0.1	0.01

	Milk, fat (reflecting 0.002 ppm in whole milk)	2.0	0.05	Milk, fat

Sheep, fat	1.0	0.05	The available data indicate that the tolerances may
be decreased.

Sheep, meat byproducts	0.1	0.01

	Sheep, meat	0.1	0.01

	

References

D315918, Fenpropathrin.  Residue Field Trials on Currants, Succulent
Shelled Peas, Blueberries, and Peppers.  Summary of Analytical Chemistry
and Residue Data, W. Cutchin,

9/20/05. 

D222174, Fenpropathrin on Melons and Brassica.  PC Code 127901. 
Evaluation of Analytical Methods and Residue Data, L. Cheng, 10/23/97.

D200755, PP4F4327, Fenpropathrin, (127901) on Peanuts.  Evaluation of
Analytical Methods and Residue Data, R. Cook, 11/21/95

D207266, PP3F4186/FAP3H5661.  Fenpropathrin (127901, Danitol) on
Tomatoes and Strawberries, Amendment dated 9/1/94. R. Cook, G. LaRocca
and J. Smith, 8/9/95

D208548, PP2F04144/2H05648.  Fenpropathrin (127901, Danitol) on Cotton. 
Submission of Cotton Metabolism Study, R. Cook, 5/2/95

D11480, Fenpropathrin (127901, Danitol).  Confined Rotational Crop Study
and Field Dissipation Study on Rotational Crops, M. Bradley, 7/1/93.

D181992, Fenpropathrin (127901, Danitol) on Cotton, Grapes, and Oranges.
 Amendments on August 4 and 7, 1992, M. Bradley, 11/4/92

DP#: None, PP#7F3485/FAP#7H5527.  Fenpropathrin (Danitol) on Apples and
Pears.  Comments on Petition Method Validation, M. Bradley, 10/24/88.

DP#:  None, PP#7F3485/7H5527.  Fenpropathrin (Danitol) on Apples and
Pears.  Evaluation of Analytical Methods and Residue Data, M. Bradley,
9/11/87.

DP#:  None, PP4G3107.  Fenpropathrin (Danitol) on Cottonseed. 
Evaluation of Analytical Method and Residue Data, R. Loranger, 10/23/84.

  SEQ CHAPTER \h \r 1 Attachments:  

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations



INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  alpha-cyano-3-phenoxy-benzyl
2,2,3,3-tetramethylcyclopropanecarboxylate	Common Name:

Fenpropathrin	X Proposed tolerance

⁪ Reevaluated tolerance

⁪ Other	Date:   1/29/08

Codex Status (Maximum Residue Limits)	U. S. Tolerances

□No Codex proposal step 6 or above

√  No Codex proposal step 6 or above for the crops requested	Petition
Numbers:  PP#4E6867, PP#6E7066, and

                               PP#7E7298

DP#s:  333113, 347513, and 348247

Other Identifier:  

Residue definition (step 8/CXL): fenpropathrin	Reviewer/Branch:  A.
Parmar/RAB2

	Residue definition:  fenpropathrin per se

Crop (s)	MRL (mg/kg)	Crop(s) 	Tolerance (ppm)

PP#4E6867

Stone fruit, Crop Group 12	1.4

Cherry, sweet and tart	5.0

Treenuts (including pistachio), Crop Group 14	0.10 (nutmeat)

	5.0 (almond hulls)

PP#6E7066

Avocado	1.0

Black Sapote	1.0

Canistel	1.0

Mamey Sapote	1.0

Mango	1.0

Papaya	1.0

Sapodilla	1.0

Star apple	1.0

Barley, grain	Withheld

Barley, hay	Withheld

Barley, straw	Withheld

PP#7E7298

Caneberry subgroup 13A	12

Olive	5.0

Limits for Canada	Limits for Mexico

 √  No Limits

□ No Limits for the crops requested	□ No Limits

 √ No Limits for the crops requested

Residue definition:  N/A	Residue definition:  fenpropatrin

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

	

Appendix I

Tolerance Assessment Calculations

For each of the crops listed below, the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data (SOP), along with the tolerance
spreadsheet (January 2008 version), was used for calculating recommended
tolerances.  As specified in the SOP, the minimum of the 95% upper
confidence limit (UCL) on the 95th percentile and the point estimate of
the 99th percentile were selected as the tolerance value in cases when
the dataset was large (greater than 15 samples) and reasonably lognormal
(barley straw and peach).  For datasets that were small (≤15 samples)
and reasonably lognormal (almond hulls, avocado, caneberries, cherries,
olives, pecan nutmeat, plum), the upper bound estimate of the 95th
percentile based on the median residue value was compared to the minimum
of the 95% UCL on the 95th percentile and the point estimate of the 99th
percentile, and the minimum value was selected as the tolerance value. 
For datasets that were not lognormal (barley hay), the upper bound on
the 89th percentile was selected as the tolerance value
(distribution-free method).  The rounding procedures specified in the
SOP were also used.

PP# 4E6867

Fruit, Stone (Crop Group 12)

The representative commodities of stone fruits are cherry, peach, and
plum.  The dataset used to establish a tolerance for residues of
fenpropathrin per se in/on stone fruits consisted of field trial data
representing application rates of 0.769-0.856 lb ai/A (2 applications at
0.382-0.435 lb ai/A/application) with a 3- to 4-day PHI.  As specified
by the SOP, the field trial application rates and PHIs are within 25% of
the maximum label application rate and minimum label PHI, respectively.

In the cherry, peach, and plum field trials, all treated samples (n=44)
bore residues of fenpropathrin above the LOQ.  The residue values used
to calculate the tolerance are provided in Table I-1

Cherry:  The cherry field trial values were entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure I-1) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure I-2) confirmed that the assumption of
lognormality should not be rejected.

The field trial data for fenpropathrin on cherry represent a small
dataset (12 samples) and are reasonably lognormal.  Using the tolerance
spreadsheet, the recommended individual tolerance for fenpropathrin is
5.0 ppm for cherry.

Peach:  The peach field trial values were entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure I-3) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure I-4) confirmed that the assumption of
lognormality should not be rejected.

The field trial data for fenpropathrin on peach represent a large
dataset (20 samples) and are reasonably lognormal.  Using the tolerance
spreadsheet, the recommended individual tolerance for fenpropathrin is
1.4 ppm for peach. 

Plum:  The plum field trial values were entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure I-5) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure I-6) confirmed that the assumption of
lognormality should not be rejected.

The field trial data for fenpropathrin on plum represent a small dataset
(11 samples) and are reasonably lognormal.  Using the tolerance
spreadsheet, the recommended individual tolerance for fenpropathrin is
0.70 ppm for plum.

In summary, the tolerance spreadsheet recommends individual tolerances
of 5.0 ppm for cherry, 1.4 ppm for peach, and 0.70 ppm for plum.  HED
recommends in favor of the proposed tolerance of 1.4 ppm for residues of
fenpropathrin per se in/on Stone Fruits except cherry (Crop Group 12). 
The recommended tolerance for both sweet and tart cherries is 5.0 ppm. 
These recommendations are revised from the levels proposed by the
petitioner.

Table I-1.	Residue data used to calculate tolerance for fenpropathrin on
stone fruits.

Regulator:	EPA	EPA	EPA

Chemical:	Fenpropathrin	Fenpropathrin	Fenpropathrin

Crop:	Cherry	Peach	Plum

PHI:	3 days	3-4 days	3-4 days

Total App. Rate:	0.769-0.833 lb ai/A	0.777-0.856 lb ai/A	0.781-0.813 lb
ai/A

Submitter:	Valent U.S.A.	Valent U.S.A.	Valent U.S.A.

MRID Citation:	MRID 46385303	MRID 46385304	MRID 46385305

	Residues of fenpropathrin (ppm)

	1.83	0.66	0.51

	1.97	0.66	0.58

	2.02	0.76	0.23

	1.60	0.63	0.23

	1.44	0.56	0.29

	1.43	0.73	0.21

	3.18	0.91	0.37

	3.33	1.11	0.27

	1.59	1.05	0.24

	1.43	1.01	0.20

	3.53	0.69	0.18

	3.23	0.72

	0.79

	0.67

	0.61

	0.54

	0.39

	0.49

	1.00

	0.84

	

Figure I-   SEQ Figure_II- \* ARABIC  1 .  Lognormal probability plot of
fenpropathrin field trial data for cherry.

Figure I- 2.   Tolerance spreadsheet summary of fenpropathrin field
trial data for cherry.

Figure I- 3.  Lognormal probability plot of fenpropathrin field trial
data for peach.

Figure I- 4.   Tolerance spreadsheet summary of fenpropathrin field
trial data for peach.

Figure I- 5.  Lognormal probability plot of fenpropathrin field trial
data for plum.

Figure I- 6.   Tolerance spreadsheet summary of fenpropathrin field
trial data for plum.

Nut, Tree (Crop Group 14)

The residue data for almond hulls and pecan nutmeat were entered into
the tolerance spreadsheet. The residue data for the nutmeat of almond,
the other representative commodity of Crop Group 14, were not entered
into the spreadsheet because >60% of the treated samples bore residues
below the LOD.  The dataset used to establish tolerances for residues of
fenpropathrin per se in/on almond hulls and pecan nutmeat consisted of
field trial data representing application rates of 0.80 lb ai/A (2
applications at 0.40 lb ai/A/application) with a 3-day PHI.  As
specified by the SOP, the field trial application rates and PHIs are
within 25% of the maximum label application rate and minimum label PHI.

The residue values used to calculate the recommended tolerances for
almond hulls and pecan nutmeat are provided in Table I-2.  All treated
samples of almond hulls (n=10) bore residues above the LOD.  Since 30%
(3 of 10 samples) of the field trial sample results for pecan nutmeat
were below the LOD, the maximum likelihood estimation (MLE) procedures
were needed to impute censored values.  The residue data for pecan
nutmeat were first entered into the MLE spreadsheet to obtain the
censored values, and the pecan nutmeat MLE dataset was then entered into
the tolerance spreadsheet.

Almond hulls:  After entering the fenpropathrin-almond hull dataset into
the spreadsheet, visual inspection of the lognormal probability plot
(Figure I-7) indicates that the dataset is reasonably lognormal.  The
result from the approximate Shapiro-Francia test statistic (Figure I-8)
confirmed that the assumption of lognormality should not be rejected.

The field trial data for fenpropathrin on almond hulls represent a small
dataset (10 samples) and are reasonably lognormal.  Using the tolerance
spreadsheet, the recommended tolerance for fenpropathrin is 4.5 ppm for
almond hulls.

Pecan nutmeat:  After entering the pecan nutmeat MLE dataset into the
tolerance spreadsheet, visual inspection of the lognormal probability
plot (Figure I-9) provided in the spreadsheet indicates that the dataset
is reasonably lognormal.  The result from the approximate
Shapiro-Francia test statistic (Figure I-10) confirmed that the
assumption of lognormality should not be rejected.

The field trial data for fenpropathrin on pecan nutmeat represent a
small dataset (10 samples) and are reasonably lognormal.  Using the
tolerance spreadsheet, the recommended individual tolerance for
fenpropathrin is 0.10 ppm for pecan nutmeat.

In summary, for almond hulls the tolerance spreadsheet recommends a
tolerance of 4.5 ppm for residues of fenpropathrin per se, which is
slightly lower than the level proposed by the petitioner. For pecan
nutmeat, the tolerance spreadsheet recommends an individual tolerance of
0.10 ppm for residues of fenpropathrin per se.  For almond nutmeat, the
maximum residues observed from the 1x field trials were 0.03 ppm.  These
levels are not significantly different and do not vary by a factor of
5x.  Based on the residue data from pecan nutmeat, HED recommends a
tolerance of 0.10 ppm for residues of fenpropathrin per se in/on Crop
Group 14.  This recommendation is identical to the level proposed by the
petitioner.

Table I-2.	Residue data used to calculate tolerance for fenpropathrin on
almond hulls and pecan nutmeat.

Regulator:	EPA	EPA

Chemical:	Fenpropathrin	Fenpropathrin

Crop Commodity:	Almond hulls	Pecan nutmeat (MLE)

PHI:	3 Days	3 Days

Total App. Rate:	0.80 lb ai/A	0.80 lb ai/A

Submitter:	Valent U.S.A.	Valent U.S.A.

MRID Citation:	MRID 46385302	MRID 46385306

	Residues of Fenpropathrin (ppm)

	2.400	0.005

	2.900	0.006

	2.700	0.010

	3.100	0.009

	3.200	0.020

	2.900	0.020

	3.500	0.020

	3.400	0.020

	4.300	0.040

	2.900	0.050

Figure I- 7.  Lognormal probability plot of fenpropathrin field trial
data for almond hulls.

Figure I- 8.   Tolerance spreadsheet summary of fenpropathrin field
trial data for almond hulls.

Figure I- 9.  Lognormal probability plot of fenpropathrin field trial
data for pecan nutmeat.

Figure I- 10.   Tolerance spreadsheet summary of fenpropathrin field
trial data for pecan nutmeat.

PP#6E7066

Avocado

The dataset used to establish a tolerance for fenpropathrin on avocado
consisted of field trial data representing application rates of
0.798-0.816 lb ai/A (2 applications at 0.397-0.408 lb ai/A/application)
with a 1-day PHI.  As specified by the SOP, the field trial application
rates and PHIs are within 25% of the maximum label application rate and
minimum label PHI.  The residue values used to calculate the tolerance
are provided in Table I-3.

All field trial sample results for avocado were above the LLMV of 0.05
ppm.  

The avocado field trial values were entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure I-11) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure I-12) confirmed that the assumption of
lognormality should not be rejected.

The field trial data for fenpropathrin on avocado represent a small
dataset (12 samples) and are reasonably lognormal.  Using the tolerance
spreadsheet, the recommended tolerance for fenpropathrin is 1.0 ppm for
avocado.

Table I-3.	Residue data used to calculate tolerance for fenpropathrin on
avocado.

Regulator:	EPA

Chemical:	Fenpropathrin

Crop:	Avocado

PHI:	1 Day

App. Rate:	0.798-0.816 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 46814801

	Residues of Fenpropathrin (ppm)

	0.42

	0.45

	0.51

	0.38

	0.58

	0.52

	0.40

	0.42

	0.31

	0.32

	0.20

	0.14

Figure I- 11.  Lognormal probability plot of fenpropathrin field trial
data for avocado.

Figure I- 12.   Tolerance spreadsheet summary of fenpropathrin field
trial data for avocado.

Barley

The dataset used to establish tolerances for fenpropathrin on barley
consisted of field trial data for barley hay and barley straw,
representing application rates of 0.195-0.204 lb ai/A with a 15- to
60-day (hay) or 45- to 96-day (straw) PHI.  As specified by the SOP, the
field trial application rates are within 25% of the maximum label
application rate.  The residue values used to calculate the tolerances
are provided in Table I-4.

All but four samples of the 48 field sample results for barley hay and
straw were above the LLMV of 0.02 ppm.  Because the number of values
with residues below the LLMV was less than 10%, MLE procedures were not
needed to impute censored values.  The datasets for barley commodities
were not small (24 samples each for barley hay and straw).

Barley hay:  The barley hay field trial values were entered into the
tolerance spreadsheet.  The result from the approximate Shapiro-Francia
test statistic (Figure I-14) indicated that the assumption of
lognormality should be rejected.  Visual inspection of the lognormal
probability plot (Figure I-13) provided in the spreadsheet confirmed
that the dataset is not lognormal.

The field trial data for fenpropathrin on barley hay are not lognormal. 
Using the tolerance spreadsheet, the recommended tolerance for
fenpropathrin is 2.5 ppm for barley hay.

Barley straw:  The barley straw field trial values were entered into the
tolerance spreadsheet.  Visual inspection of the lognormal probability
plot (Figure I-15) provided in the spreadsheet indicates that the
dataset is reasonably lognormal.  The result from the approximate
Shapiro-Francia test statistic (Figure I-16) confirmed that the
assumption of lognormality should not be rejected.

The field trial data for fenpropathrin on barley straw represent a large
dataset (24 samples) and are reasonably lognormal.  Using the tolerance
spreadsheet, the recommended tolerance for fenpropathrin is 4.0 ppm for
barley straw.

Table I-4.	Residue data used to calculate tolerance for fenpropathrin on
barley hay and straw.  

Regulator:	EPA	EPA

Chemical:	Fenpropathrin	Fenpropathrin

Crop:	Barley hay	Barley straw

PHI:	15-60 Days	45-96 Days

App. Rate:	0.195-0.204 lb ai/A	0.195-0.204 lb ai/A

Submitter:	IR-4	IR-4

MRID Citation:	MRID 46814802	MRID 46814802

	Residues of Fenpropathrin (ppm)

	1.810	0.790

	2.050	1.270

	0.420	0.022

	0.490	0.020

	0.510	0.790

	0.450	0.870

	0.260	0.079

	0.250	0.078

	1.570	0.160

	1.260	0.170

	1.380	0.200

	1.440	0.180

	0.160	0.043

	0.160	0.052

	0.440	0.051

	0.360	0.046

	0.510	0.400

	0.680	0.360

	0.540	0.550

	0.650	0.570

	0.300	0.420

	0.680	0.690

	0.020	0.020

	0.020	0.025

Figure I-13.  Lognormal probability plot of fenpropathrin field trial
data for barley hay.

Figure I- 14.   Tolerance spreadsheet summary of fenpropathrin field
trial data for barley hay.

Figure I-15.  Lognormal probability plot of fenpropathrin field trial
data for barley straw.

Figure I- 16.   Tolerance spreadsheet summary of fenpropathrin field
trial data for barley straw.

PP#7E7298

Caneberry (Subgroup 13A)

The dataset used to establish a tolerance for residues of fenpropathrin
per se in/on caneberries consisted of field trial data representing
application rates of 0.795-0.860 lb ai/A (2 applications at 0.394-0.436
lb ai/A/application) with a 2- to 3-day PHI.  As specified by the SOP,
the field trial application rates and PHIs are within 25% of the maximum
label application rate and minimum label PHI, respectively.  The
representative commodities of caneberry are any one blackberry or any
one raspberry.  Data were submitted for both of these crops.

The results of the field trials on blackberry and raspberry showed that
all treated samples (n=14) bore residues of fenpropathrin above the LLMV
of 0.02 ppm.  The residue values used to calculate the tolerance are
provided in Table I-5.

	

 

-

#

-

7

摧ẍU؀7

8

9

@

A

E

…

†

–

—

˜

 

§

´

¿

Á

Â

Ã

×

Ø

Û

÷

ø

-˜

¡

¢

Ù

>

`

Æ

Ç

È

É

 

6

_

`

{

|

~



“

”

•

—

™

š

®

°

Ä

Å

$Å

Æ

Ç

É

Ê

Þ

ß

 h

 h

+É

hl

 h

 h

옍)

혈Fᴃἀ⼍괛$Ȇ

혈Fᴃἀ⼍괛$Ȇ

혈Fᴃἀ⼍괛$Ȇ

혈Fᴃἀ⼍괛$Ȇ

혈Fᴃἀ⼍괛$Ȇ

혈Fᴃἀ⼍괛$Ȇ

혈Fᴃἀ⼍괛$Ȇ

혈Fᴃἀ⼍괛$Ȇ

혈Fᴃἀ⼍괛$Ȇ

,

 h

 hF;

㐀ۖĀ̊d搃昀Ĵ瑹皥

d

d

d

d

 ha

 ha

 hª

ഀ׆Ā褐㄀Ĥ摧皥

gd皥

愀Ĥ摧皥

愀Ĥ摧皥

愀Ĥ摧皥

ഀ׆Ā褐㄀Ĥ摧皥

h

h

愀Ĥ摧ȅ£ఀ

	ԀĤ␆㄁Ĥ摧噤Y

²

³

g

h

 

)

,

-

;

R

U

V

[

o

r

s

x

†

³

Ç

Ð

*

0

e

f

h

hM

 h

hM

 hM

hM

hM

  h

 h

h

攃昀Ĵ瑹皥

aĤ摧皥

愀Ĥ摧皥

摧䙷

愀Ĥ摧皥

aĤ摧皥

愀Ĥ摧皥

愀Ĥ摧皥

愀Ĥ摧皥

愀Ĥ摧皥

愀Ĥ摧皥

愀Ĥ摧皥

愀Ĥ摧皥

愀Ĥ摧皥

 h$ 

 h$ 

 h$ 

 h$ 

 h$ 

 h$ 

$

$

 h$ 

kd

 h6

hB

`„Èûgd¯

gd¯

gd¯

yt¯

gd¯

yt¯

gd¯

yt¯

gd¯

yt¯

gd¯

yt¯

gd¯

yt¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

yt¯

 h6

 h6

gd¯

gd¯

gd¯

gd¯

yt¯

`„Èûgd¯

gd¯

gd¯

yt¯

gd¯

gd¯

gd¯

yt¯

gd¯

yt¯

gd¯

yt¯

gd¯

yt¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

gd¯

yt¯

`„Èûgd¯

gd¯

gd¯

gd¯

gd¯

gd¯

gd¯

gd¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

gd¯

gd¯

yt¯

yt¯

`„Èûgd¯

gd¯

gd¯

gd¯

gd¯

yt¯

gd¯

gd¯

m

m

yt¯

gd¯

gd¯

m

m

yt¯

gd¯

gd¯

m

m

yt¯

gd¯

gd¯

m

m

yt¯

gd¯

gd¯

m

m

yt¯

gd¯

gd¯

m

m

yt¯

gd¯

gd¯

m

m

yt¯

gd¯

gd¯

gd¯

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

gd¯

gd¯

gd¯

	m

	m

yt¯

`„Èûgd¯

gd¯

gd¯

gd¯

gd¯

hB

 h6

>hapiro-Francia test statistic (Figure I-18) confirmed that the
assumption of lognormality should not be rejected.

The field trial data for fenpropathrin on caneberry represent a small
dataset (14 samples) and are reasonably lognormal.  Using the tolerance
spreadsheet, the recommended individual tolerance for fenpropathrin is
12.0 ppm for the Caneberry Crop Subgroup (13-07A).

Table I-5.	Residue data used to calculate tolerance for fenpropathrin on
caneberry.

Regulator:	EPA

Chemical:	Fenpropathrin

Crop:	Caneberry (blackberry/raspberry)

PHI:	2-3 Days

App. Rate:	0.795-0.860 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 47295501

	Residues of Fenpropathrin (ppm)

	1.000

	1.200

	5.500

	6.100

	4.100

	7.100

	1.400

	1.900

	3.300

	4.700

	1.700

	1.800

	1.800

	2.300

Figure I- 17.  Lognormal probability plot of fenpropathrin field trial
data for caneberry.

Figure I- 18.   Tolerance spreadsheet summary of fenpropathrin field
trial data for caneberry.

Olive

The dataset used to establish a tolerance for fenpropathrin on olive
consisted of field trial data representing application rates of
0.801-0.847 lb ai/A (2 applications at 0.400-0.427 lb ai/A/application)
with a 7- to 8-day PHI.  As specified by the SOP, the field trial
application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  The residue
values used to calculate the tolerance are provided in Table I-6.  

All field trial sample results for olive were above the LLMV of 0.02
ppm.  

The olive field trial values were entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure I-19) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure I-20) confirmed that the assumption of
lognormality should not be rejected.

The field trial data for fenpropathrin on olive represent a small
dataset (6 samples) and are reasonably lognormal.  Using the tolerance
spreadsheet, the recommended tolerance for fenpropathrin is 5.0 ppm for
olive.



Table I-6.	Residue data used to calculate tolerance for fenpropathrin on
olive.

Regulator:	EPA

Chemical:	Fenpropathrin

Crop:	Olive fruit without pit

PHI:	7-8 Days

App. Rate:	0.801-0.847 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 47295502

	Residues of Fenpropathrin (ppm)

	2.100

	2.300

	1.800

	2.000

	3.400

	3.700

Figure I- 19.  Lognormal probability plot of fenpropathrin field trial
data for olive.

Figure I- 12.   Tolerance spreadsheet summary of fenpropathrin field
trial data for olive.

Fenpropathrin	Summary of Analytical Chemistry and Residue Data	DP#:
320347

Page   PAGE  1  of   NUMPAGES  56