U.S. ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDES

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  		17-MAR-2009

SUBJECT:	Fenpyroximate.  Petition for the Establishment of Permanent Tolerances on Fruiting Vegetable (Crop Group 8), Melon (Crop Subgroup 9A), Cucumber, and Okra.  Summary of Analytical Chemistry and Residue Data.

PC Code:  129131	DP Barcode:  D354703

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

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

Risk Assessment Type:  NA	Case No.:  NA

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

MRID No.:  See MRID Summary Table	40 CFR:  §180.566

FROM:	George F. Kramer, Ph.D., Senior Chemist  SEQ CHAPTER \h \r 1

		Registration Action Branch (RAB 1)

		Health Effects Division (HED) (7509C)

THROUGH:	Dana M. Vogel, Branch Chief

		RAB1/HED (7509P)

TO:		Sidney Jackson/Daniel Rosenblatt, PM Team 05

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

MRID Summary Table.

MRID No.	Study Type	Comments

47439602	860.1500 Pepper	New DER; 47439602.der.doc

47439604	860.1500 Tomato	New DER; 47439604.de1.doc

	860.1520 Tomato 	New DER; 47439604.de2.doc

47439603	860.1500 Cantaloupe	New DER; 47439603.der.doc

47439605, 47439606	860.1500 Cucumber	New DER; 47439605.der.doc (Includes MRID 47439606)

  SEQ CHAPTER \h \r 1 This document was originally prepared under contract by Dynamac Corporation (2275 Research Boulevard, Suite 300; Rockville, MD 20850; submitted 09/10/2008).  The document has been reviewed by HED and revised to reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

The Interregional Research Project No. 4 (IR-4), on behalf of the Agricultural Experiment Stations of NC, SC, CA, TX, TN, GA, NJ, and AZ (tomato use); FL, OK, TN, NC, GA, KY, MS, and SC (pepper use); NC (okra use); NC and TN (cantaloupe use); and FL (greenhouse cucumber use), requests the establishment of permanent tolerances for the combined residues of the insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene] amino]oxy]methyl] benzoate and its Z-isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene] amino]oxy] methyl]benzoate in/on the following commodities:

Vegetable, fruiting, group 8	0.20 ppm

Okra	0.20 ppm

Melon subgroup 9A	0.03 ppm

Cucumber	0.05 ppm

  SEQ CHAPTER \h \r 1 Fenpyroximate is a contact insecticide/miticide used for the control of leafhoppers, mealybugs, and mites.  The mode of action is similar to that of pyridaben and acequinocyl.  Fenpyroximate is a mitochondrial electron-transport inhibitor (METI) by targeting proton-translocating NADH:Q oxidoreductase and blocking ubiquinone reduction.

The end-use products (EPs) associated with this registration action are Fujimite® 5EC Miticide/Insecticide (EPA Reg. No. 71711-19) and Akari® 5SC Miticide/Insecticide (EPA Reg. No. 71711-4).  The U.S. registrations of these EPs are currently held by Nichino America, Inc.  IR-4 proposes to amend the labels for these products to incorporate new uses on the crops addressed in this petition.  Fujimite® is an emulsifiable-concentrate (EC) formulation containing 5% ai (equivalent to 0.4 lb ai/gal) and is proposed for foliar spray applications of fruiting vegetables, okra, and melons at a maximum seasonal rate of 0.2 lb ai/A with preharvest intervals (PHIs) of 1 day (fruiting vegetables and okra) or 3 days (melons).  Akari® is a suspension-concentrate (SC; equivalent to flowable-concentrate) formulation containing 5% ai (equivalent to 0.42 lb ai/gal) and is proposed for foliar spray applications of greenhouse-grown cucumbers at a maximum seasonal rate of 0.1 lb ai/A with a PHI of 7 days.

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

The nature of the residue in plants is adequately understood based on acceptable plant metabolism studies conducted in apple, citrus, cotton, and grape.  The residues of concern in crops for purposes of tolerance enforcement and risk assessment are the parent compound and its Z-isomer (Metabolite M-1).

The residue chemistry data requirements pertaining to livestock metabolism, residue analytical methods, and storage stability for livestock as well as magnitude of the residue in meat, milk, poultry, and eggs are not germane to this registration action because there are no feedstuffs associated with the proposed uses on fruiting vegetables, melons, cucumber, and okra.

An adequate enforcement method is available for determination of fenpyroximate residues of concern in plants.  A gas chromatography method with nitrogen/phosphorus detection (GC/NPD), Method S19, has passed an Agency validation (DP# 269410, 10/10/00, G. Kramer).  Method S19 has a limit of quantitation of 0.10 ppm for the combined residues of fenpyroximate and its Z-isomer.  The enforcement analytical method data should be upgraded to support the expanded uses of fenpyroximate proposed under the current petition.  The method should be re-written to include instructions for the analysis of fruiting vegetables (crop group 8), okra, melon subgroup 9A, and cucumber.  In connection with a previous tolerance petition for fenpyroximate on pome fruit, cotton, and grapes (PP#s 0F06437 and 0E06519, 8/20/03, G. Kramer), the petitioner was required to demonstrate the specificity of Method S19 by performing an interference study with all pesticides for which tolerances are established on the subject crops, or to submit a specific confirmatory method [e.g., one using mass spectrometry (MS) detection].  This data requirement remains outstanding.

Samples collected from the magnitude of the residue, storage stability, and processing studies were analyzed for residues of fenpyroximate and its Z-isomer using modifications of method DFG S19.  The analytical methods used are adequate for data collection based on acceptable method recoveries which were generally within the acceptable range of 70-120%.  The enforcement analytical method and the modified versions used for data collection determined residues of fenpyroximate and its Z-isomer separately in all matrices except pepper and cantaloupe.  Due to the potential for isomerization between fenpyroximate and its Z-isomer in pepper and cantaloupe, the results were reported as combined residues (with both analytes determined as the Z-isomer).  Although the method used for pepper and cantaloupe did not differ significantly in procedure from the original enforcement analytical method, the petitioner stated that for analysis of the subject commodities, fenpyroximate was converted to the Z-isomer in the injector area of the GC; however, it is noted that this conversion was not always complete, as shown by the presence of a double peak in several of the sample chromatograms.  The petitioner should provide further explanation for this observation, addressing whether conversion to the Z isomer is specific to certain crop commodities such as cantaloupe and pepper or was the result of the instrument conditions used for analysis of subject commodity samples.

Data pertaining to multiresidue methods testing were previously submitted in conjunction with a petition for fenpyroximate tolerances on imported wine grapes and hops (PP#5E04435).  Fenpyroximate was not adequately recovered by any multiresidue protocol.

There are adequate storage stability data to support the integrity of samples collected from the magnitude of the residue studies.  Concurrently storage stability studies show that the combined residues of fenpyroximate and its Z-isomer are reasonably stable under frozen storage conditions for up to 12 months in cantaloupe, ~13 months in non-bell pepper, ~19 months in tomato, and ~17 months in tomato paste and puree.  No corrections need be applied to any of the magnitude of the residue studies.  The submitted storage stability data for tomato will be translated to cucumber.

The submitted residue data for bell pepper, non-bell pepper, and tomato are adequate to support the establishment of a tolerance for fruiting vegetables, crop group 8.  The trials were conducted according to the proposed use rate and PHI.  The maximum combined residues of fenpyroximate and its Z-isomer in/on samples treated at 1x and collected at a 1-day PHI were:  0.075 ppm for bell peppers grown in the field, 0.069 ppm for bell peppers grown in greenhouse, 0.12 ppm for non-bell peppers grown in the field, 0.056 ppm for non-bell peppers grown in greenhouse, 0.185 ppm for tomatoes grown in the field, and 0.174 ppm for tomatoes grown in greenhouse.  Statistical analysis of residue data reflecting the proposed use pattern confirms that that the proposed tolerance of 0.20 ppm residues in/on fruiting vegetables, crop group 8, is adequate.

No okra residue data were submitted in support the proposed use on okra.  IR-4 is proposing to translate the existing fruiting vegetable data (peppers and tomatoes) to okra.  According to the Science Advisory Council for Chemistry (ChemSAC) decision of 10/18/06, HED has approved adding okra to the fruiting vegetable crop group.  Until 40 CFR 180.41 is updated, a separate tolerance must be established for residues in/on okra.

The submitted residue data for cantaloupe are adequate to support the establishment of a tolerance for residues in/on melon subgroup 9A pending submission of a revised Section F.  The trials were conducted according to the proposed use rate and PHI.  The combined residues of fenpyroximate and its Z-isomer were each below the limit of quantitation (LOQ) of 0.05 ppm in/on all treated samples.  A revised Section F is required to amend the proposed tolerance for residues in/on the melon subgroup 9A from 0.03 ppm to 0.10 ppm (the LOQ of the enforcement method for combined residues).

The submitted residue data for cucumber are adequate to support the establishment of a raw agricultural commodity (RAC) residue tolerance pending submission of a revised Section F.  The trials reflect the proposed use pattern but were conducted in Europe under greenhouse or polytunnel conditions.  The maximum combined residues of fenpyroximate and its Z-isomer in/on cucumbers treated at 1x and collected at the proposed 7-day PHI were <0.03 ppm.  Although the tolerance spreadsheet recommends a tolerance level of 0.06 ppm for cucumber, the appropriate RAC tolerance is 0.10 ppm (the LOQ of the enforcement method for combined residues).  A revised Section F is required to amend the proposed tolerance for residues in/on cucumber from 0.05 ppm to 0.10 ppm.

An adequate tomato processing study was submitted, and the results indicate that the combined residues of fenpyroximate and its Z-isomer did not concentrate in tomato paste (average processing factor of <0.89x) and tomato puree (average processing factor of <0.57x) processed from whole tomatoes bearing detectable combined residues.  Based on these data, tolerances are not needed for tomato processed commodities.

An adequate confined rotational crop study is available.  [14C]Fenpyroximate was applied to sandy loam soil at 0.20 lb ai/A (1-2x the maximum seasonal rate to annual crops addressed in this petition).  Crops of radish, lettuce, and wheat were planted at 30, 120, and 365 days after treatment.  Residues were too low to allow for metabolite identification.  A field rotational crop study and rotational crop tolerances will, therefore, not be needed to support the proposed and registered uses.  The proposed 30-day plant-back interval is appropriate.

Codex and Mexican maximum residue limits (MRLs) are established for residues of fenpyroximate per se in/on several crop commodities but not for the crops requested.  Harmonization with the other Codex and Mexican MRLs is not possible because the U.S. tolerance expressions include additional metabolites/isomers.  There are currently no established Canadian MRLs.

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

  SEQ CHAPTER \h \r 1 Pending submission of revised Sections B and F, there are no residue chemistry issues that would preclude granting conditional registrations for this insecticide on fruiting vegetables (crop group 8), okra, melon subgroup 9A, and cucumber, and the establishment of permanent tolerances for the combined residues of fenpyroximate and its Z-isomer as follows:

Vegetable, fruiting, group 8	0.20 ppm

Okra	0.20 ppm

Melon, subgroup 9A	0.10 ppm

Cucumber	0.10 ppm

The registrations on fruiting vegetables (crop group 8), okra, melon subgroup 9A, and cucumber should be conditional pending the submission of an analytical reference standard for fenpyroximate and the resolution of the data gaps pertaining to residue analytical methods.

A human-health risk assessment is forthcoming in a separate document.

  SEQ CHAPTER \h \r 1 Residue Chemistry Deficiencies

860.1200 Directions for Use

A revised Section B is required to clarify the proposed use on greenhouse cucumbers.  The maximum seasonal rate of 0.1 lb ai/A is inconsistent with the label specification that two applications may be made at 0.1 lb ai/A per application.  The submitted data will support only one application at 0.1 lb ai/A per growing season.  In addition, the label directions regarding use of ultra-low volume (ULV) equipment on greenhouse cucumbers should be deleted since no data reflecting this application equipment was conducted on any cucumber trials.  Also, the labels should be revised to prohibit use of adjuvants on the subject crops as residue data were not provided to support their use.

  SEQ CHAPTER \h \r 1 860.1340 Residue Analytical Method - Plant Commodities

The available enforcement analytical method data should be upgraded to support the expanded uses of fenpyroximate proposed under the current petition.  The method should be rewritten to include instructions for the analysis of fruiting vegetable, okra, melon, and cucumber.

The requirement for an interference study demonstrating the specificity of the enforcement method, or a specific confirmatory method (e.g., use of MS detection) remains outstanding.  If the petitioner can validate LC/MS/MS Method AJW/03/01 on the registered crops and the crops addressed in this petition, then this requirement will be fulfilled.

Clarifications are required for the analytical methods used for pepper and cantaloupe.  Due to the potential for isomerization between fenpyroximate and its Z-isomer in peppers and cantaloupes, the results were reported as combined residues (with both analytes determined as the Z-isomer).  Although the method used for peppers and cantaloupes did not differ significantly in the procedure from the original enforcement analytical method, the petitioner stated that for analysis of the subject commodities, fenpyroximate was converted to the Z-isomer in the injector area of the gas chromatograph; however, it is noted that this conversion was not always complete, as shown by the presence of double peaks in several of the sample chromatograms.  The petitioner should provide further explanation for this observation, addressing whether conversion to the Z isomer is specific to certain crop commodities such as cantaloupe and pepper or was the result of the instrument conditions used for analysis of subject commodity samples.

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

Analytical standards for fenpyroximate (with expiration date of 12/6/08) and its Z-isomer (with expiration date of 6/21/10) are currently available in the EPA National Pesticide Standards Repository.  Since the standards for fenpyroximate are about to expire, the petitioner is requested to provide a new supply to the Repository.  The reference standards 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.)

860.1550 Proposed Tolerances

The petitioner is required to submit a revised Section F to amend the proposed tolerances for:  (i) melon subgroup 9A, from 0.03 ppm to 0.10 ppm; and (ii) cucumber, from 0.05 ppm to 0.10 ppm.Background

The chemical structure and nomenclature of fenpyroximate and its metabolites and the physicochemical properties of the technical grade of fenpyroximate are presented in Tables 1 and 2.

Common name	Fenpyroximate

Company experimental name	NNI-850

IUPAC name tert-butyl(E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-ox y)-p-toluate

CAS name	1,1-dimethylethyl 4-[[[(E)-[(1,3-dimethyl-5-phenoxy1H-pyrazol-4-yl)methylene]-amino]oxy]me thyl]benzoate

CAS registry number	134098-61-6 (E isomer);

111812-58-9 (unspecified stereochemistry)

End-use product (EP)	FujiMite® 5% EC (EPA Reg. No. 71711-19)

1,1-dimethylethyl 4-[[[(Z)-[(1,3-dimethyl-5-phenoxy1H-pyrazol-4-yl)methylene]-amino]oxy]me thyl]benzoate

Metabolite M1

Table 2.  Physicochemical Properties of Fenpyroximate.

Parameter	Value	Reference

Melting range	99.3-101.7 °C	D301316, 5/3/04, L. Kutney

pH	5.63-6.10	D301316, 5/3/04, L. Kutney

Density	1.247-1.257 g/mL at 20 °C	D301316, 5/3/04, L. Kutney

Water solubility	Water, pH 5 - 21.4 ppb	21.4 ppb

Water, pH 7 -  23.1 ppb 	23.1 ppb

Water, pH 9 – 29.8 ppb	29.8 ppb	D257640, 8/20/99, G. Kramer

Solvent solubility	  SEQ CHAPTER \h \r 1 Acetone                  15.0 g/100 mL

Chloroform    SEQ CHAPTER \h \r 1          119.7 g/100 mL

DMSO                    2.86 g/100 mL

Ethanol                   1.65 g/100 mL

Ethyl acetate           20.1 g/100 mL

Hexane                   0.35 g/100 mL

Methanol                1.53 g/100 mL

Methylene chloride  130.7 g/100 mL

Tetrahydrofuran        73.7 g/100 mL

Toluene                     26.8 g/100 mL

Xylene                       19.3 g/100 mL	D301316, 5/3/04, L. Kutney

Vapor pressure	5.6 x 10-8  Pa at 25 °C 	D257640, 8/20/99, G. Kramer

Dissociation constant, pKa	Not applicable; nearly insoluble in water D301316, 5/3/04, L. Kutney

Octanol/water partition coefficient, Log(KOW)	log Pow = 5.01 (PAI) D301316, 5/3/04, L. Kutney

860.1200 Directions for Use

The end-use products associated with this registration action are Fujimite® 5EC Miticide/Insecticide (EPA Reg. No. 71711-19) and Akari® 5SC Miticide/Insecticide (EPA Reg. No. 71711-4); see Table 3A.  Fujimite® is an EC formulation containing 5% ai (equivalent to 0.4 lb ai/gal) and is proposed for use on fruiting vegetables except cucurbits, melon subgroup 9A, and okra.  Akari® is an SC (translatable to FlC) formulation containing 5% ai (equivalent to 0.42 lb ai/gal).  A summary of the proposed crop use patterns is presented in Table 3B.

Table 3A.  Summary of Proposed End-Use Products.

Trade Name	EPA

Reg. No.	ai (% of formulation)	Formulation Type	Target Crops	Target Pests	Label Date

Fujimite® 5EC Miticide/

Insecticide	71711-19	5% (equivalent to 0.4 lb ai/gal)	Emulsifiable

Concentrate	Fruiting vegetables except cucurbits, melon subgroup 9A,

and okra	Leafhoppers, mealybugs, mites or psylla	Undated draft label

Akari® 5SC Miticide/

Insecticide	71711-4 	5% (equivalent to 0.42 lb ai/gal)	Suspension concentrate	Greenhouse cucumbers	Mites including spider mites	Undated draft label

Table 3B.  Summary of Proposed Directions for Use of Fenpyroximate.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]

Applic. Rate 	Max. No. Applic. per Season	Max. Seasonal Applic. Rate	PHI

(days)

Fruiting Vegetables, Crop Group 8 (Field and Greenhouse) [Including:  Eggplant; Ground Cherry (Physalis spp.); Pepino; Peppers including Bell Pepper, Chili Pepper, Cooking Pepper, Pimento, and Sweet Pepper; Tomatillo; and Tomato]; and Okra1

Foliar spray

Ground or airblast	Fujimite® 5EC;

0.4 lb/gal EC

[71711-19]	0.1 lb ai/A	2	0.2 lb ai/A	1

	Use Directions and Limitations:  Apply in a minimum of 20 gallons per acre (GPA) of water for ground applications (or 100 GPA on greenhouse tomatoes).  Use of higher carrier volume is recommended for heavy infestations and in situations where thorough coverage is difficult to achieve.  Do not apply through any type of irrigation system.  The product should be used in a rotational program with other products with alternative modes of action to provide resistance management.  A 12-hour restricted entry interval (REI) is proposed.

Melon Subgroup 9A (Including Cantaloupe, Citrus Melon, and Watermelon)

Foliar spray

Ground or airblast	Fujimite® 5EC;

0.4 lb/gal EC

[71711-19]	0.1 lb ai/A	2	0.2 lb ai/A	3

	Use Directions and Limitations:  Apply in a minimum of 20 GPA for ground applications.  Use of higher carrier volume is recommended for heavy infestations and in situations where thorough coverage is difficult to achieve.  The product should be used in a rotational program with other products with alternative modes of action to provide resistance management.  Do not apply through any type of irrigation system.  A 12-hour REI is proposed.

Greenhouse Cucumbers

Foliar spray

Ground	Akari® 5SC

0.42 lb/gal SC

[71711-4]	0.1 lb ai/A	2	0.1 lb ai/A	7

	Use Directions and Limitations:  Apply in a minimum of 100 GPA for ground applications.  Use of higher carrier volume is recommended for heavy infestations and in situations where thorough coverage is difficult to achieve.  Apply using backpack sprayer equipment.  Applications may also be made with high volume, low volume, or ULV (thermal and non-thermal foggers, misters, etc.)  Do not apply through any type of irrigation system.  Do not use Akari® 5SC in successive miticide applications per resistance management statements on the label.  A 12-hour REI is proposed.

1  Based on the minutes of the ChemSAC meeting of 10/18/06, HED has approved adding okra to the fruiting vegetable crop group.

The proposed label for Fujimite® 5EC Miticide/Insecticide (EPA Reg. No. 71711-19) specifies that application by air is prohibited on the proposed crops; application by air is recommended only for cotton, a registered crop.  In addition, the following rotational crop restriction appears on the label:  “Do not plant rotational crops other than those listed on the label for 30 days following the last application of this product.”

Conclusions:  The proposed use patterns on fruiting vegetables, melons, and okra are adequate to allow evaluation of the residue data submitted in support of this petition.  However, the proposed use on greenhouse cucumber must be clarified as the maximum proposed seasonal rate of 0.1 lb ai/A is inconsistent with the label specification that two applications may be made at 0.1 lb ai/A per application.  The submitted data will support one application at 0.1 lb ai/A per growing season.  In addition, the label direction regarding use of ULV equipment on greenhouse cucumbers should be deleted since no data reflecting this application equipment was conducted on any cucumber trials.  Also, the labels should be revised to prohibit use of adjuvants on the subject crops as residue data were not provided to support their use.

860.1300 Nature of the Residue - Plants

  SEQ CHAPTER \h \r 1 No plant metabolism studies were submitted with the subject petition.  Acceptable plant metabolism studies with fenpyroximate on apples, citrus, cotton, and grapes were previously submitted in support of tolerance petitions for uses on imported wine grapes and hops (PP#5E04435; DP# 292394, 8/20/03, G. Kramer) and pome fruit, cotton, and grapes (PP#s 0F06437 and 0E06519; DP#s 291925 and 291926, 8/20/03, G. Kramer).  HED has determined (DP# 292639, 7/12/03, J. Stokes) that the residues of concern for purposes of tolerance enforcement and risk assessment are the parent compound plus its Z-isomer (M-1).  The available plant metabolism data are adequate to support the proposed uses on fruiting vegetables, melons, cucumbers, and okra.  The residues of concern in these commodities are fenpyroximate and its Z-isomer.

860.1300 Nature of the Residue - Livestock

Data requirements regarding this guideline topic are not germane to this petition because there are no feedstuffs associated with the proposed uses on fruiting vegetables, melons, cucumbers, and okra.

860.1340 Residue Analytical Methods

  SEQ CHAPTER \h \r 1 Plant Commodities

Enforcement Analytical Method:  An acceptable enforcement method, GC/NPD method DFG S19, is available for plant commodities.  This method has undergone a petition method validation (DP# 269410, 10/10/00, G. Kramer) and is listed in the U.S. EPA Index of Residue Analytical Methods under fenpyroximate, Method ID 2000_109M, “Quantitation of Fenpyroximate Residues in Raw Agricultural and Processed Commodities.”  The details of the method are summarized in Table 4.

In conjunction with PP#s 0F06437, 0E06519, and 5E04435 (DP# 291925, 8/20/03, G. Kramer; and DP# 292394, 8/20/03, G. Kramer), HED required the submission of an interference study demonstrating the specificity of Method S19, or a specific confirmatory method (e.g., use of MS detection).  This data requirement remains outstanding.

Table 4.  Summary of Enforcement Analytical Method for Plant Commodities1.

Apple, citrus, cotton, hops, and grape RACs and processed commodities

Method ID	2000_109M

Method DFG S19

PTRL West Study Numbers 819W, 820W, 825W, and 826W

Reference	43586401, 45097201, 45132701, and 45649905

Extraction solvent/technique	Samples are extracted with acetone; water is added to the acetone in an amount that takes account of the natural water content of the sample so that during extraction the acetone:water ratio remains constant [e.g., acetone:water (4:1, v:v)].  The extract is collected by filtration and an excess of sodium chloride is added.2

Cleanup strategies	The extract is partitioned with dichloromethane (DCM) followed by ethyl acetate to separate excess water; the DCM phase and ethyl acetate are dried through anhydrous sodium sulfate and combined.  The resulting organic phase is concentrated to dryness and reconstituted in ethyl acetate:cyclohexane (1:1, v:v), then purified by gel-permeation chromatography (GPC) followed by silica-gel solid-phase extraction (SPE).  Residues are eluted from the GPC column using ethyl acetate:cyclohexane (1:1, v:v) and from the SPE column using toluene:acetone (95:5, v:v).

Instrument/Detector	GC/NPD

Analytes	Fenpyroximate and its Z-isomer (M-1)3

LOQ	0.05 ppm each for fenpyroximate and its Z-isomer in cotton, grapes, and hops; defined as the lowest fortification level yielding acceptable recoveries (80-120%).

Limit of detection (LOD)	0.02 ppm each for fenpyroximate and its Z-isomer in cotton, grapes, and hops (defined as the lower standard used (quantitated) in the preparation of the calibration curves.

Radiovalidation/

Extraction Efficiency 	HED determined that radiovalidation data were not required because the extraction procedure employed by Method DFG S19 is similar to that used in the metabolism studies (D250098, 12/21/98, G. Kramer).

Independent Laboratory Validation (ILV)	Adequate validation was provided for fenpyroximate and its Z-isomer from samples fortified with fenpyroximate and its Z-isomer (1:1) at 0.010 and 0.10 ppm in apple, 0.05 and 0.50 ppm in grape,0.02 and 0.20 ppm in cotton seed, and 0.05 and 0.50 ppm in cotton seed oil (refer to 45659905.der.wpd).

Petition method validation (PMV)	The method has undergone a successful PMV (D269410, 10/10/00, G. Kramer).

1  The method is summarized according to the write-up presented in the U.S. EPA Index of Residue Analytical Methods.

2  Acetonitrile (ACN) was listed as the extraction solvent for cottonseed oil in the ILV (refer to 45649905.der.wpd).

3  It was noted that “total” fenpyroximate should be calculated by combining the peak values (area or height) for both fenpyroximate and its Z-isomer, due to the potential for isomerization between fenpyroximate and its Z-isomer and the significant enhancement of fenpyroximate recovery from matrix effects in certain commodities.

  SEQ CHAPTER \h \r 1 Data-collection methods:  Samples collected from the magnitude of the residue, storage stability, and processing studies were analyzed for residues of fenpyroximate and its Z-isomer using modifications of method DFG S19.  Abbreviated details of the methods are summarized in Table 5 for purposes of comparison with the enforcement method.  The analytical methods used are adequate for data collection based on acceptable method recoveries which were generally within the acceptable range of 70-120%.

The enforcement analytical method and the modified versions used for data collection determine residues of fenpyroximate and its Z-isomer separately in all matrices except peppers and cantaloupe.  Due to the potential for isomerization between fenpyroximate and its Z-isomer in pepper and cantaloupe, the results were reported as combined residues (with both analytes determined as the Z-isomer).  Although the method used for pepper and cantaloupe did not differ significantly in procedure from the original enforcement analytical method, the petitioner stated that for analysis of the subject commodities, fenpyroximate was converted to the Z-isomer in the injector area of the GC; however, it is noted that this conversion was not always complete, as shown by the presence of double peaks in several of the sample chromatograms.  The petitioner should provide further explanation for this observation, addressing whether conversion to the Z isomer is specific to certain crop commodities such as cantaloupe and pepper or was the result of the instrument conditions used for analysis of subject commodity samples.

Table 5.  Summary of Data-Collection Methods for Analysis of Samples from the Magnitude of the Residue, Storage Stability, and Processing Studies.

Pepper, Bell and Non-Bell

Method ID	Modified version of PTRL Study Numbers P819W and P820W

Performing Laboratory	IR-4 Western Region Laboratory (Davis, CA)

Reference	47439602

Extraction solvent/technique	Residues in/on samples were extracted with acetone:water (4:1, v:v).

Cleanup Strategies	Partitioned with DCM; organic phase evaporated to dryness and reconstituted in hexane

Florisil:  residues eluted with ethyl acetate:hexane (20:80, v:v)

SPE: residues eluted with 5% isopropanol in hexane

Eluate evaporated to dryness and taken up in 1% corn oil in hexane

Instrument/Detector	GC/NPD

Analytes	Fenpyroximate and Z-isomer (determined as the Z-isomer)

LOQ	0.05 ppm for the combined residues (defined as 3x the LOD)

LOD	0.008 ppm (calculated from the lowest level of method validation (LLMV) of 0.05 ppm) for combined residues of fenpyroximate and its Z-isomer

Method performance	Acceptable method validation and concurrent recoveries (combined residues as the Z-isomer) were obtained from samples fortified at 0.05-5.0 ppm.

Tomato RAC and Tomato Processed Commodities

Method ID	Working outline 9111.1 v 1; modified version of PTRL Study Numbers P819W and P820W

Performing Laboratory	IR-4 North Central Region Laboratory (Lansing, MI)

Reference	47439604

Extraction solvent/technique	Residues in/on samples were extracted with acetone:water (4:1, v:v).

Cleanup Strategies	None.

Instrument/Detector	LC/MS/MS

Analytes	Fenpyroximate and its Z-isomer (determined separately)

LOQ	Tomato RAC:  0.02339 ppm for fenpyroximate and 0.03174 ppm for its Z-isomer

Tomato paste:  0.04331 ppm for fenpyroximate and 0.04439 ppm for its Z-isomer

Tomato puree:  0.02505 ppm for fenpyroximate and 0.03053 ppm for its Z-isomer

(defined as 3x LOD)

LOD	Tomato RAC:  0.00780 ppm for fenpyroximate and 0.01058 ppm for its Z-isomer

Tomato paste:  0.01444 ppm for fenpyroximate and 0.01480 ppm for its Z-isomer

Tomato puree:  0.00835 ppm for fenpyroximate and 0.01018 ppm for its Z-isomer

(calculated from the LLMV of 0.05 ppm)

Method performance	Acceptable method validation and concurrent recoveries (fenpyroximate + Z-isomer) were obtained from samples fortified at 0.05-5.0 ppm.

Cantaloupe

Method ID	Modified version of PTRL Study Numbers P819W and P820W

Performing Laboratory	IR-4 Western Region Laboratory (Davis, CA)

Reference	47439603

Extraction solvent/technique	Residues in/on samples were extracted with acetone:water (4:1, v:v).

Cleanup Strategies	Partitioned with DCM; organic phase evaporated to dryness and reconstituted in hexane.

Florisil:  residues eluted with ethyl acetate:hexane (20:80, v:v)

Carbon SPE: residues eluted with 5% isopropanol in hexane

Eluate evaporated to dryness and taken up in 1% corn oil in hexane

Instrument/Detector	GC/NPD

Analytes	Fenpyroximate and Z-isomer (determined as the Z-isomer)

LOQ	0.05 ppm (defined as 3x LOD) for combined residues of fenpyroximate and its Z-isomer

LOD	0.015 ppm (calculated from the LLMV of 0.05 ppm) for combined residues of fenpyroximate and its Z-isomer

Method performance	Acceptable method validation and concurrent recoveries (combined residues as the Z-isomer) were obtained from samples fortified at 0.05-5.0 ppm.

Cucumber

Method used prior to 1/23/03

Method ID	Fenpyroximate/Crops/DB/01/02

Performing Laboratory	Agrisearch UK

Reference	47439605

Extraction solvent/technique	Residues in/on samples were extracted with water and acetone.

Cleanup Strategies	Partitioned into dichloromethane and dried with anhydrous sodium sulfate

Concentrated and redissolved in cyclohexane:ethyl acetate (1:1, v:v)

Gel permeation chromatography; residues eluted with cyclohexane:ethyl acetate (1:1, v:v)

Evaporated to dryness and redissolved in ethyl acetate

Instrument/Detector	GC/MS

Analytes	Fenpyroximate and its Z-isomer (determined separately)

LOQ	0.01 ppm for each analyte

LOD	Not reported

Method performance	Acceptable concurrent recoveries (fenpyroximate + Z-isomer) were obtained from samples fortified at 0.01-0.2 ppm.

Method used after 1/23/03

Method ID	Fenpyroximate/Crops/AJW/03/01

Performing Laboratory	Agrisearch UK

Reference	47439605 & 47439606

Extraction solvent/technique	Residues in/on samples were extracted with ethyl acetate.

Cleanup Strategies	Octanol added.

Sample evaporated to dryness and redissolved in methanol.

Instrument/Detector	LC/MS/MS

Analytes	Fenpyroximate and its Z-isomer (determined separately)

LOQ	0.01 ppm for each analyte

LOD	Not reported

Method performance	Acceptable concurrent recoveries (fenpyroximate + Z-isomer) were obtained from samples fortified at 0.02-0.5 ppm.

  SEQ CHAPTER \h \r 1 Conclusions:  The available enforcement analytical method data should be upgraded to support the expanded uses of fenpyroximate proposed under the current petition.  The method should be rewritten to include instructions for the analysis of fruiting vegetables, melons, cucumbers, and okra.

The requirement for an interference study demonstrating the specificity of the enforcement method, or a specific confirmatory method (e.g., use of MS detection) remains outstanding.  If the petitioner can validate LC/MS/MS Method AJW/03/01 on the registered crops and the crops addressed in this petition, then this requirement will be fulfilled.

Clarifications are required for the analytical methods used for pepper and cantaloupe.  Due to the potential for isomerization between fenpyroximate and its Z-isomer in peppers and cantaloupes, the results were reported as combined residues (with both analytes determined as the Z-isomer).  Although the method used for peppers and cantaloupes did not differ significantly in procedure from the original enforcement analytical method, the petitioner stated that for analysis of the subject commodities, fenpyroximate was converted to the Z-isomer in the injector area of the gas chromatograph; however, it is noted that this conversion is not always complete, as shown by the presence of a double peak in several of the sample chromatograms.  The petitioner should provide further explanation for this observation, addressing whether conversion to the Z isomer is specific to certain crop commodities such as cantaloupe and pepper or was the result of the instrument conditions used for analysis of subject commodity samples.

860.1360 Multiresidue Methods

  SEQ CHAPTER \h \r 1 Data pertaining to multiresidue methods testing were previously submitted in conjunction with a petition for fenpyroximate tolerances on imported wine grapes and hops (PP#5E04435; DP# 292394, 8/20/03, G. Kramer).  Fenpyroximate was not adequately recovered by any multiresidue protocol.  No further data are required.

860.1380 Storage Stability

  SEQ CHAPTER \h \r 1 IR-4 has submitted the results of storage stability studies with fenpyroximate and its Z-isomer.  The storage stability studies were conducted concurrently with the field trial and processing studies associated with the current petition.  The results of these studies were incorporated in the DERs generated for the respective magnitude of the residue study submissions.  Based on the reported results, the combined residues of fenpyroximate and its Z-isomer appear to be stable during frozen storage for up to 12 months in cantaloupes, ~13 months in non-bell peppers, ~19 months in tomatoes, and ~17 months in tomato paste and puree.

The storage durations and conditions of samples from the submitted crop trial and processing studies are presented in Table 6.  The reported storage duration represents the interval from sample collection to analysis.

Table 6.  Summary of Storage Intervals and Storage Stability Data.

Matrix [MRID]	Storage Temperature (°C)	Actual Storage Duration	Interval of Demonstrated Storage Stability

Cantaloupe

[47439603]	<-1 at the field sites; <-20 at the analytical laboratory 249-316 days

months)	364 days (12.0 months)

Cucumber fruit

[47439605]	<-18	110-586 days

(3.6-19.3 months)	None submitted

Cucumber extract

[47439603]	<-18	3-76 days

(0.1-2.5 months)	None submitted

Pepper, bell

[47439602]	Frozen at the field sites; <-20 at the analytical laboratory 275-396 days

(9.0-13.0 months)	403 days (13.2 months)

Pepper, non-bell

[47439602]	Frozen at the field sites; <-20 at the analytical laboratory 286-380 days

(9.4-12.5 months)

	Tomato

[47439604]	Frozen at the field sites; -29 to -10 at the analytical laboratory	477-626 days

(15.7-20.6 months)	567 days (18.6 months).

Tomato paste

[47439604]	-29 to -10 at the analytical laboratory	523-547 days

(17.2-18.0 months)	529 days (17.4 months)

Tomato puree

[47439604]

522-546 days

(17.1-17.9 months)	532 days (17.5 months)

Conclusions:    SEQ CHAPTER \h \r 1 The submitted storage stability data for cantaloupe, non-bell pepper, tomato, and tomato paste and puree are acceptable and indicate that residues of fenpyroximate and its Z-isomer are relatively stable in/on frozen commodities for the intervals tested.  No corrections need be applied to any of the magnitude of the residue studies.  The submitted storage stability data for tomatoes, peppers, and cantaloupe will be translated to cucumber.

HED notes that 0-day data were not provided for the tested matrices.  However, additional data will not be required for this petition as the available data for other commodities indicates that fenpyroximate residues are relatively stable in/on frozen commodities for the intervals stored.  The petitioner should note for future storage stability studies that HED requires that the sampling points include zero time to establish the residue levels present at the time samples are placed into storage.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the crops addressed herein.  Therefore, data requirements pertaining to meat, milk, poultry, and eggs are not relevant to this tolerance petition.

860.1500 Crop Field Trials

Vegetable, Fruiting, Crop Group 8

Pepper

47439602.der.doc

IR-4 has submitted magnitude of the residue data for fenpyroximate on bell and non-bell pepper from supervised trials conducted under field and greenhouse conditions.  Thirteen field trials and three greenhouse trials were conducted on peppers in the U.S. during the 2005 growing season.  The distribution of trials included:  eight bell pepper field trials in Zones 2 (NC and TN; 2 trials), 3 (FL; 2 trials), 5 (WI; 1 trial), 6 (TX; 1 trial), and 10 (CA; 2 trials); five non-bell pepper field trials in Zones 2 (NC), 3 (FL), 5 (OH), 6 (TX), and 10 (NM); two bell pepper greenhouse trials in Zones 2 (NJ) and 6 (TX); and one non-bell pepper greenhouse trial in Zone 9 (CO).

At each trial, two foliar applications of a 0.4 lb/gal EC formulation of fenpyroximate (Fujimite® 5EC Miticide/Insecticide, EPA Reg. No. 71711-19) were made to growing peppers during the blooming to fruiting stages at a target rate of ~0.10 lb ai/A per application, with a 13- to 16-day retreatment interval (RTI), for a total seasonal rate of ~0.20 lb ai/A (1.0x the maximum proposed seasonal rate).  In two trials, the plots received three applications due to freezer failure in one instance (08617.05-TN05) and rainfall after the second application in the other (08617.05-NC04).  Applications were made in ~42-79 gal/A spray volumes using ground equipment.  An adjuvant was not added to the spray mixture for any applications.  Samples of mature pepper fruits were harvested from treated and untreated plots 1 day after the last application (DALA) at all trials.  At two field trials (a NM non-bell pepper trial and a NC bell pepper trial), additional samples were collected immediately after the last application (0 DALA) and 3, 7, and 12 or 14 DALA to assess residue decline.

The results (see Table 7) show that following two foliar applications of Fujimite® 5EC Miticide/Insecticide at a target rate of ~0.10 lb ai/A per application for a total rate of ~0.20 lb ai/A, the maximum combined residues of fenpyroximate and its Z-isomer in/on samples collected at a 1-day PHI were:  0.075 ppm for bell peppers grown in the field, 0.069 ppm for bell peppers grown in greenhouse, 0.12 ppm for non-bell peppers grown in the field, and 0.056 ppm for non-bell peppers grown in greenhouse.

The residue decline trial indicated that the combined residues generally remained steady in/on bell peppers and decreased in/on non-bell peppers with increasing sampling intervals.  In the bell pepper decline trial, maximum combined residues were 0.095 ppm at the 0-day PHI and were 0.094 ppm at the 12-day PHI; in the non-bell pepper decline trial, maximum combined residues declined from 0.12 ppm at the 1-day PHI to <0.05 ppm at the 14-day PHI.

Table 7.  Summary of Residue Data from Pepper Trials with Fenpyroximate.

Commodity	Total Applic. Rate (lb ai/A)	PHI (days)	Combined Residue Levels (ppm)1

	n	Min.	Max.	HAFT	Median	Mean	Std. Dev.

Proposed Use Pattern = Maximum seasonal rate of 0.2 lb ai/A with a 1-day PHI

Pepper, bell

(field trials)	0.201-0.203	1	12	<0.05	0.075	0.066	0.050	0.057	0.010

	0.298-0.313	0	2	0.093	0.095	0.094	0.094	0.094	--

1	4	<0.05	0.133	0.127	0.085	0.088	0.044

3	2	0.098	0.110	0.104	0.104	0.104	--

7	2	0.096	0.099	0.098	0.098	0.098	--

12	2	0.070	0.094	0.082	0.082	0.082

	Pepper, bell

(greenhouse trials)	0.202-0.206	1	4	<0.05	0.069	0.069	0.059	0.059	0.011

Pepper, non-bell

(field trials)	0.200-0.206	1	10	<0.05	0.12	0.12	0.050	0.064	0.027

3	2	<0.05	<0.05	0.05	0.05	0.05	--

7	2	<0.05	<0.05	0.05	0.05	0.05	--

14	2	<0.05	<0.05	0.05	0.05	0.05	--

Pepper, non-bell

(greenhouse trials)	0.204	1	2	0.052	0.056	0.054	0.054	0.054	--

1  Combined residues of fenpyroximate and its Z-isomer (Metabolite M-1).  In the calculation of the median, mean, and standard deviation, the combined LOQ of 0.05 ppm was used for residues reported as less than the LOQ.

Tomato

47439604.de1.doc

IR-4 has submitted magnitude of the residue data for fenpyroximate on tomatoes from supervised trials conducted under field and greenhouse conditions.  A total of 19 tomato trials was conducted in the U.S. during the 2005 growing season including:  16 field trials in Zones 1 (NY; 1 trial), 2 (GA; 1 trial), 3 (FL; 2 trials), 5 (OH; 1 trial), and 10 (CA; 9 trials and NM; 2 trials), and 3 greenhouse trials in Zones 3 (FL; 1 trial), 6 (TX; 1 trial), and 9 (CO; 1 trial).  Of these trials, two field trials (one CA and one OH trial) planted tomatoes of a small-fruited variety.

At each test location, two foliar applications of a 0.4 lb/gal EC formulation of fenpyroximate (Fujimite® 5EC Miticide/Insecticide, EPA Reg. No. 71711-19) were made to established tomato plants during the fruiting stage at a target rate of ~0.10 lb ai/A per application, with a 12- to 23-day RTI, for a total seasonal rate of ~0.20 lb ai/A (1.0x the maximum proposed seasonal rate).  One trial (OH) received a third application, for a total rate of 0.313 lb ai/A, due to delayed maturity of the tomato crop.  Applications were made in 21-68 gal/A spray volumes using ground equipment.  An adjuvant was not added to the spray mixture for any applications.  Samples of commercially mature tomatoes were harvested one day after the second (or third) application at all field and greenhouse trials.  At two trials (one in FL and one in NM), additional samples were collected 0 (NM only), 3, 7, 13-14, and 21 (FL only) days following the second application in order to generate residue decline data.

Preliminary analysis of collected samples for residues of fenpyroximate and its Z-isomer (Metabolite M-1) was made using a GC/NPD method identified by PTRL Study Numbers P819W and P820W.  However, the laboratory experienced low sensitivity with the NPD detector in the referenced method, and as a result, final analysis was carried out using an LC/MS/MS method.  The calculated LOQs were 0.02339 ppm for fenpyroximate and 0.03174 ppm for M-1 in/on tomato fruit.  The LLMV was 0.05 ppm for each analyte.  The LC/MS/MS method was adequate for data collection based on acceptable method validation and concurrent method recovery data.

The tomato trials (see Table 8) show that following two foliar applications of Fujimite® 5EC Miticide/Insecticide at a target rate of ~0.10 lb ai/A per application for a total rate of ~0.20 lb ai/A, the maximum combined residues of fenpyroximate and its Z-isomer in/on samples collected at a 1-day PHI were 0.185 ppm for tomatoes grown in the field and 0.174 ppm for tomatoes grown in greenhouse.  Lower combined residues of <0.055 ppm were obtained for field-grown tomatoes treated with three foliar applications of the test formulation.  The residue decline trials indicated that the combined residues of fenpyroximate generally decreased with increasing sampling intervals; residues of M-1 were nonquantifiable in/on all samples at all sampling intervals (except for one day-1 sample).

Table 8.  Summary of Residue Data from Tomato Trials with Fenpyroximate.

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Analyte	Residue Levels (ppm)1

n	Min.	Max.	HAFT2	Median	Mean	Std. Dev.

Proposed Use Pattern = Maximum seasonal rate of 0.2 lb ai/A with a 1-day PHI

Tomato, field-grown	0.198-0.248	0	Fenpyroximate	2	0.046	0.053	0.050 0.050	0.050	--

	M-1	2	<0.032	<0.032	0.032	0.032	0.032	--

	Combined	2	0.078	0.085	0.082	0.082	0.082	--

1	Fenpyroximate	30	<0.023	0.123	0.115	0.052	0.059	0.025

	M-1	30	<0.032	0.062	0.055	0.032	0.033	0.006

	Combined	30	<0.055	0.185	0.170	0.084	0.092	0.029

3	Fenpyroximate	4	0.026	0.043	0.042	0.038	0.036	0.008

	M-1	4	<0.032	<0.032	0.032	0.032	0.032	--

	Combined	4	0.058	0.075	0.074	0.070	0.068	0.008

7	Fenpyroximate	4	0.023	0.049	0.047	0.035	0.035	0.014

	M-1	4	<0.032	<0.032	0.032	0.032	0.032	--

	Combined	4	0.055	0.081	0.079	0.066	0.067	0.014

13-14	Fenpyroximate	4	0.023	0.054	0.042	0.027	0.033	0.015

	M-1	4	<0.032	<0.032	0.032	0.032	0.032	--

	Combined	4	0.055	0.086	0.074	0.058	0.065	0.015

21	Fenpyroximate	2	<0.023	<0.023	0.023	0.023	0.023	--

	M-1	2	<0.032	<0.032	0.032	0.032	0.032	--

	Combined	2	<0.055	<0.055	0.055	0.055	0.055	--

	0.303	1	Fenpyroximate	2	<0.023	<0.023	0.023	0.023	0.023	--

	M-1	2	<0.032	<0.032	0.032	0.032	0.032	--

	Combined	2	<0.055	<0.055	0.055	0.055	0.055	--

Tomato, greenhouse-grown	0.195-0.208	1	Fenpyroximate	6	0.066	0.142	0.108 0.076	0.085	0.028

	M-1	6	<0.032	<0.032	0.032	0.032	0.032	--

	Combined	6	0.098	0.174	0.140	0.107	0.117	0.028

1  For calculation of the median, mean, and standard deviation, the LOQs (0.02339 ppm for fenpyroximate, 0.03174 ppm for M-1, and 0.05513 ppm for combined residues) were used for residues reported as less than the LOQ.

Conclusions:  The submitted residue data for bell pepper, non-bell pepper, and tomato, which are the representative commodities of fruiting vegetables, crop group 8, are adequate to fulfill data requirements.  The number and locations of trials conducted are in accordance with OPPTS Guideline 860.1500.  The trials reflect the proposed use pattern.

The residue data for the representative commodities were separately 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 spreadsheet recommends tolerances of 0.20 ppm for tomato, 0.10 ppm for bell pepper, and 0.20 ppm for non-bell pepper.  Since the recommended tolerances differ by less than 5x, a crop group tolerance of 0.20 ppm will be appropriate for fruiting vegetables, crop group 8.  This recommendation is identical to the tolerance level proposed by the petitioner for residues in/on fruiting vegetables.

Okra

No okra residue data were submitted in support the proposed use on okra.  IR-4 is proposing to translate the existing fruiting vegetable data (peppers and tomatoes) to okra.  According to the ChemSAC decision of 10/18/06, HED has approved adding okra to the fruiting vegetable crop group.  Until 40 CFR 180.41 is updated, a separate tolerance must be established for residues in/on okra.

Melon Subgroup 9A

Cantaloupe

47439603.der.doc

IR-4 has submitted magnitude of the residue data for fenpyroximate on cantaloupe.  Eight supervised cantaloupe field trials were conducted in the U.S. in Zones 2 (GA; 1 trial), 5 (OH; 1 trial), 6 (TX; 2 trials), and 10 (NM; 1 trial and CA; 3 trials) during the 2005 growing season.  At each trial, two foliar applications of a 0.4 lb/gal EC formulation of fenpyroximate (Fujimite® 5EC Miticide/Insecticide, EPA Reg. No. 71711-19) were made to growing cantaloupes during the crop’s budding and fruiting stages at a target rate of ~0.10 lb ai/A per application, with a 12- to 16-day RTI, for a total seasonal rate of ~0.20 lb ai/A (1x the maximum proposed seasonal rate).  Applications were made in ~30-54 gal/A spray volumes using ground equipment.  An adjuvant was not added to the spray mixture for any applications.  Samples of commercially mature cantaloupes were harvested 2 to 3 days after the second application.  At one CA trial, additional samples were collected at 1-, 7-, 13-, and 21-day PHIs to evaluate residue decline.

The field trials (see Table 9) indicate that following two foliar applications of Fujimite® 5EC Miticide/Insecticide at a target rate of ~0.10 lb ai/A per application for a total rate of ~0.20 lb ai/A, the maximum combined residues of fenpyroximate and its Z-isomer in/on cantaloupe samples collected at a 2- to 3-day PHI were below the method LOQ (0.05 ppm).  The decline trial also show that the combined residues were nonquantifiable (<0.05 ppm) in/on all samples of cantaloupe fruits harvested 1, 3, 7, 13, or 21 days following the second of two foliar spray applications.

Table 9.  Summary of Residue Data from Cantaloupe Field Trials with Fenpyroximate.

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Combined Residue Levels1 (ppm)

	n	Min.	Max.	HAFT	Median	Mean	Std. Dev.

Proposed Use Pattern = Maximum seasonal rate of 0.2 lb ai/A with a 3-day PHI

Cantaloupe, fruit	0.197-0.202	1	2	<0.05	<0.05	0.05	0.05	0.05	--

2-3	16	<0.05	<0.05	0.05	0.05	0.05	--

7	2	<0.05	<0.05	0.05	0.05	0.05	--

13	2	<0.05	<0.05	0.05	0.05	0.05	--

21	2	<0.05	<0.05	0.05	0.05	0.05	--

1  Combined residues of fenpyroximate and its Z-isomer (Metabolite M-1).  In the calculation of the median and mean, the combined LOQ of 0.05 ppm was used for residues reported as less than the LOQ.

Conclusions:  The submitted residue data for cantaloupe, the representative commodity of melon subgroup 9A, are adequate to fulfill data requirements.  The number and locations of trials conducted are in accordance with OPPTS Guideline 860.1500.  The trials reflect the proposed use pattern.  The residue data were not entered into the Agency’s tolerance spreadsheet because all treated samples bore combined residues below the LOQ of 0.05 ppm.  The available data for cantaloupe will support a tolerance of 0.10 ppm (the combined LOQs of the enforcement method) for residues in/on melon subgroup 9A.  A revised Section F is required to amend the proposed tolerance for residues in/on melon subgroup 9A from 0.03 ppm to 0.10 ppm

Cucumber

47439605.der.doc (Includes MRID 47439606)

IR-4 has submitted two studies which depict magnitude of the residue data for fenpyroximate on cucumbers grown under greenhouse (MRID 47439605) or polytunnel conditions (MRID 47439606).  A total of nine supervised cucumber trials were conducted in Europe during the 2001 and 2002 growing seasons including three trials in France, two in Spain, one in Italy, and three in the UK.

At each trial location, a single foliar spray application of a 5% suspension concentrate formulation of fenpyroximate (Akari® 5SC Miticide/Insecticide, EPA Reg. No. 71711-4) was made to established and growing cucumber plants at a rate of 0.08-0.10 lb ai/A (~1x the maximum proposed seasonal rate).  Applications were made in 93-113 gal/A spray volumes using ground equipment.  The spray mixture did not include an adjuvant.  Samples of mature and market-ready cucumbers were collected at preharvest intervals of 0 days (4 trials), 3 days (4 trials), 7 days (all 9 trials), and 10 days (all 9 trials).

The results (see Table 10) show that following one application of a 5% SC formulation of fenpyroximate at 0.08-0.10 lb ai/A, the maximum combined residues of fenpyroximate and its Z-isomer in/on cucumbers were <0.05 ppm at 0-day PHI, <0.04 ppm at 3-day PHI, <0.03 ppm at 7-day PHI, and <0.02 ppm at 10-day PHI.  The maximum individual residue of fenpyroximate was 0.04 ppm at 0-day PHI; individual residue of the Z-isomer was <0.01 ppm in/on all treated samples.

Table 10.  Summary of Residue Data from Greenhouse Cucumber Trials with Fenpyroximate.

Commodity	Total Applic. Rate

 (lb ai/A)	PHI (days)	Analyte	Residue Levels (ppm)1

n	Min.	Max.	HAFT	Median	Mean	Std. Dev.

Proposed Use Pattern = Maximum seasonal rate of 0.1 lb ai/A with a 7-day PHI

Cucumber, fruit	0.09-0.10	0	Fenpyroximate	4	0.03	0.04	0.04	0.04	0.04 0.006

	M-1	4	<0.01	<0.01	0.01	0.01	0.01	--

	Combined	4	<0.04	<0.05	0.05	0.05	0.05	0.006

3	Fenpyroximate	4	<0.01	0.03	0.03	0.02	0.02	0.008

	M-1	4	<0.01	<0.01	0.01	0.01	0.01	--

	Combined	4	<0.02	<0.04	0.04	0.03	0.03	0.008

	0.08-0.10	7	Fenpyroximate	9	<0.01	0.02	0.02	0.01	0.01	0.005

	M-1	9	<0.01	<0.01	0.01	0.01	0.01	--

	Combined	9	<0.02	<0.03	0.03	0.02	0.02	0.005

10	Fenpyroximate	9	<0.01	<0.01	0.01	0.01	0.01	--

	M-1	9	<0.01	<0.01	0.01	0.01	0.01	--

	Combined	9	<0.02	<0.02	0.02	0.02	0.02	--

1  In the calculation of median, mean, and standard deviation, the LOQ (0.01 ppm for each analyte) was used for residues reported below the LOQ.

Conclusions:  The submitted residue data for cucumber are adequate to fulfill data requirements.  The trials reflect the proposed use pattern but were conducted in Europe under greenhouse or polytunnel conditions.  ChemSAC decision of 3/26/08 approved use the European residue data to support of fenpyroximate on greenhouse-grown cucumbers in the U.S.  The residue data for cucumber 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.  Although the spreadsheet recommends a tolerance of 0.06 ppm for cucumber, the appropriate RAC tolerance is 0.10 ppm (the combined LOQs of the enforcement method).  A revised Section F is required to amend the proposed tolerance for residues in/on cucumber from 0.05 ppm to 0.10 ppm.

860.1520 Processed Food and Feed

Tomato

47439604.de2.doc

IR-4 has submitted a tomato processing study with fenpyroximate.  The tomato samples used for processing were generated from two field trials conducted in the states of CA and NY.  The test formulation was a 0.4 lb/gal EC formulation of fenpyroximate (Fujimite® 5EC Miticide/Insecticide, EPA Reg. No. 71711-19) which was foliarly sprayed twice to established tomato plants at a target rate of 0.2 lb ai/A per application, with a 12- to 14-day RTI, for a total of ~0.4 lb ai/A (2x the maximum proposed seasonal rate).  Commercially mature tomatoes were harvested from the treatment and control plots one day following the second application.  The harvested tomatoes were processed into paste and puree using simulated commercial processing procedures.

Individual residues of fenpyroximate and Metabolite M-1 in/on treated tomato RAC samples ranged 0.065-0.094 ppm and <0.032-0.035 ppm, respectively, with combined residues ranging <0.097-0.129 ppm.  The processing data indicate that residues of fenpyroximate per se did not concentrate in tomato paste or puree as all processing factors were <1.0x.  Residues of Metabolite M-1 did not concentrate in tomato puree; however, residues of M-1 concentrated slightly in tomato paste (processing factor of <1.3x from the NY sample).  When residues are combined, the average processing factors were <0.89x for tomato paste and <0.57x for tomato puree; see Table 11.

The calculated processing factors do not exceed the theoretical concentration factors of 1.4x for tomato paste and 5.5x for tomato puree (OPPTS 860.1520, Table 2).

Table 11.  Average Processing Factors from Tomato Processing Study with Fenpyroximate.

Processed Commodity	Fenpyroximate	M-1	Fenpyroximate + M-1

Tomato paste	<0.69x	NC	<0.89x

Tomato puree	<0.41x	NC	<0.57x

Conclusions:  The submitted tomato processing data are adequate to satisfy data requirements.  The processing data indicate that residues of fenpyroximate per se did not concentrate in tomato paste or puree as all processing factors were <1.0x.  Residues of the Z-isomer (Metabolite M-1) did not concentrate in tomato puree; however, residues of M-1 concentrated slightly in tomato paste (processing factor of <1.3x from the NY sample).  When residues are combined, the average processing factors were <0.89x for tomato paste and <0.57x for tomato puree.  Based on these data, tolerances are not needed for residues in/on tomato processed commodities.

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

Analytical standards for fenpyroximate (with expiration date of 12/6/08) and its Z-isomer (with expiration date of 6/21/10) are currently available in the EPA National Pesticide Standards Repository (personal communication with Dallas Wright, ACB, 8/21/08).  Since the standards for fenpyroximate are about to expire, the petitioner is requested to provide a new supply to the Repository.  The reference standards 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.)

  SEQ CHAPTER \h \r 1 860.1850 Confined Accumulation in Rotational Crops

860.1900 Field Accumulation in Rotational Crops

The crops (fruiting vegetables, melons, cucumbers, and okra) proposed under the current petition may be rotated.  No new confined rotational crop data were submitted with this petition.  An acceptable confined rotational crop study was previously submitted in support of the tolerance petition for uses on pome fruits, cotton, and grapes (PP#s 0F06437 and 0E06519; DP#s 291925 and 291926, 8/20/03, G. Kramer; 45649913.der.wpd).  In the study, lettuce, radish, and wheat were planted 30, 120, and 365 days following treatment of sandy loam soil at 0.2 lb ai/A.  The application rate used in the study is 1-2x the proposed maximum seasonal rate to the crops addressed in this petition.

The rotational crop data indicated that fenpyroximate-related residues were <0.01 ppm in all samples of rotated lettuce, radish, and wheat planted at 30-, 120-, and 365-day PBIs except wheat straw from the 120-day PBI.  The proposed 30-day plant-back interval on the product labels is appropriate.

860.1550 Proposed Tolerances

IR-4 has proposed a tolerance expression in terms of the combined residues of the insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl- 5-phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl] benzoate and its Z-isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5- phenoxy-1H- pyrazol-4-yl)methylene] amino]oxy]methyl]benzoate.  HED has determined that the residues of concern for purposes of tolerance enforcement and risk assessment are the parent compound plus its Z-isomer (Metabolite M-1).

Fenpyroximate tolerances for plant commodities have been established in 40 CFR §180.566 and are expressed in terms of the combined residues of fenpyroximate and its Z-isomer.  The tolerance expression proposed by the petitioner is consistent with the 40 CFR §180.566 as well as HED’s determination of residues of concern.

Codex and Mexican MRLs are established for residues of fenpyroximate per se in/on several crop commodities but not for the crops requested.  Harmonization with the other Codex and Mexican MRLs is not possible because the U.S. tolerance expressions include additional metabolites/isomers.  There are currently no established Canadian MRLs.

The submitted residue data for fruiting vegetables (bell pepper, non-bell pepper, and tomato) and cucumbers were entered into the tolerance spreadsheet as per Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data in order to determine appropriate tolerance levels; see Appendix I.  The submitted residue data for cantaloupe were not entered into the tolerance spreadsheet because all treated samples bore combined residues below the LOQ of 0.05 ppm.

For the representative members of the fruiting vegetables, the spreadsheet recommends tolerances of 0.20 ppm for tomato, 0.10 ppm for bell pepper, and 0.20 ppm for non-bell pepper.  Since the recommended tolerances differ by less than 5x, a crop group tolerance of 0.20 ppm will be appropriate for fruiting vegetable, crop group 8.  This recommendation is identical to the tolerance level proposed by the petitioner for fruiting vegetables.

For okra, the submitted residue data for pepper and tomato will be translated to support the proposed tolerance of 0.20 ppm for residues in/on this crop commodity.

For cucumber, the spreadsheet recommends a RAC tolerance of 0.06 ppm.  However, the appropriate RAC tolerance is 0.10 ppm (the LOQ of the enforcement method for combined residues).  A revised Section F is required to amend the proposed tolerance for residues in/on cucumber from 0.05 ppm to 0.10 ppm.

For cantaloupe, a revised Section F is required to amend the proposed tolerance for residues in/on melon subgroup 9A, from 0.03 ppm to 0.10 ppm

A summary of recommended tolerances for the current petition is listed in Table 12.

Table 12.  Tolerance Summary for Fenpyroximate.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;

Correct Commodity Definition

Vegetable, fruiting, group 8	0.20	0.20

	Okra	0.20	0.20

	Melon subgroup 9A	0.03	0.10	A revised section F is required.

Cucumber	0.05	0.10	A revised section F is required.

References

DP#:		257640

Subject:	PP#5E04435.  Fenpyroximate in or on Imported Wine Grapes and Hops.  HED Risk Assessment.

From:		G. Kramer

To:		M. Banks, A. Layne

Dated:		8/20/99

MRIDs:	None

  SEQ CHAPTER \h \r 1 DP#:		269410

Subject:	PP#5E04435.  Fenpyroximate in or on Imported Wine Grapes and Hops.  Results of Petition Method Validation (PMV).  Chemical No. 129131.  Case 286423.  Submission S581012.

From:		G. Kramer

To:		M. Banks/A. Layne

Dated:		10/10/00

MRID(s):	45132701

  SEQ CHAPTER \h \r 1 DP#s:		291925 and 291926

Subject:	Fenpyroximate in/on Pome Fruit, Cotton, and Grapes.  PP#s 0F06437 & 0E06519.  Summary of Analytical Chemistry and Residue Data.  PC Code:  129131.  40 CFR 180.566.

From:		G. Kramer

To:		M. Banks/M. Johnson, H. Jamerson/R. Forrest

Dated:		8/20/03

MRID(s):	45649901-45649913 and 45775501

  SEQ CHAPTER \h \r 1 DP#:		292394

Subject:	PP#5E04435.  Fenpyroximate in or on Imported Wine Grapes and Hops.  Review of Amendment Dated 12/20/02 Submitted in Response to HED’s Memo of 12/21/98.  Request for Reconsideration of Additional Data Requirements.  Chemical 129131.  Decision # 299904.

From:		G. Kramer

To:		M. Banks/M. Johnson

Dated:		8/20/03

MRID(s):	45097201

DP#:		301316

Subject:	Product Chemistry Review of ‘Fenpyroximate Technical’

From:		L. Kutney

To:		R. Gebken, M. Banks

Dated:		5/3/04

MRIDs:	None

  SEQ CHAPTER \h \r 1 Attachments:

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

cc:  G. Kramer (RAB1)

RDI:  RAB1 Chemists (10/29/08)

G.F. Kramer:S10781:PY-S:(703)305-5079:7509P:RAB1

Template Version September 2005

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  1,1-dimethylethyl 4-[[[(E)-[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)m瑥票敬敮ⵝ浡湩 嵯硯嵹敭桴汹扝湥潺瑡ݥ潃浭湯丠浡㩥ഠ敆灮特硯浩瑡 ݥ
牐灯獯摥琠汯牥湡散

 Reevaluated tolerance

 Other	Date:  8/19/2008

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 Number:  8E7365

DP#:  354703

Residue definition (step 8/CXL):  fenpyroximate.  The residue is fat soluble.	Reviewer/Branch:  G. Kramer, RAB1

	Proposed tolerance expression:  Combined residues of the insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene] amino]oxy]methyl] benzoate and its Z-isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5- phenoxy-1H-pyrazol-4-yl)methylene] amino]oxy] methyl]benzoate

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

Vegetable, fruiting, group 8	0.20

Okra	0.20

Melon subgroup 9A	0.03

Cucumber	0.05

	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:  fenpyroximate

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

	Notes/Special Instructions: S. Funk, 08/20/2008.

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 was selected as the tolerance value in cases when the dataset was large (greater than 15 samples) and reasonably lognormal.  For datasets that were small (≤15 samples) and reasonably lognormal, 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, 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.

Vegetables, Fruiting, Crop Group 8

The dataset used to establish a tolerance for fenpyroximate on fruiting vegetable consisted of field-grown trial data for tomato, bell pepper, and non-bell pepper (the representative crops of fruiting vegetable), representing application rate of 0.2 lb ai/A (2 applications at 0.1 lb ai/A per application) with a 1-day PHI.  The field trial application rate and PHI are within 25% of the maximum label application rate and minimum label PHI, respectively.  The residue values that were entered into the tolerance spreadsheet are provided in Table I-1.

All except 2 field trial sample results for tomato were above the combined LOQ (combined LOQ for tomato = 0.055 ppm).  Because 7 of 12 trial sample results for bell pepper and 6 of 10 trial sample results for non-bell pepper were below LOQ (combined LOQ for pepper = 0.05 ppm), maximum-likelihood estimation (MLE) procedures were needed to impute censored values for these crops.  For all 3 crops, visual inspection of the lognormal probability plots (Figures I-1, I-3, and I-5) and the results from the approximate Shapiro-Francia test statistic (Figures I-2, I-4, and I-6) indicated that the datasets were reasonably lognormal.

Using the tolerance spreadsheet, the recommended tolerances are 0.20 ppm for tomato, 0.10 ppm for bell pepper, and 0.20 ppm for non-bell pepper.  Because the minimum and maximum recommended tolerances differ by less than 5x, a crop group tolerance is appropriate for fruiting vegetable.  The recommended value is 0.20 ppm, the maximum of the recommended individual tolerances.

Table I-1.	Residue data used to calculate tolerance for Fenpyroximate on Fruiting Vegetable.

Regulator:	EPA	EPA	EPA

Chemical:	Fenpyroximate	Fenpyroximate	Fenpyroximate

Crop:	Tomato- Field	Pepper, bell (MLE) - Field	Pepper, non-bell (MLE) - Field

PHI:	1 Day	1 Day	1 Day

App. Rate:	0.195-0.248 lb ai/A	0.201-0.206 lb ai/A	0.200-0.206 lb ai/A

Submitter:	IR-4	IR-4	IR-4

MRID Citation:	MRID 47439604	MRID 47439602	MRID 47439602

	Combined Residues of Fenpyroximate and its Z-isomer (ppm)

	0.074	0.030	0.023

	0.075	0.033	0.027

	0.098	0.036	0.031

	0.105	0.058	0.035

	0.140	0.056	0.110

	0.096	0.075	0.120

	0.123	0.067	0.050

	0.108	0.074	0.057

	0.073	0.038	0.042

	0.078	0.040	0.046

	0.066	0.042

0.069	0.044

0.089

	0.085

	0.085

	0.083

	0.077

	0.076

	0.109

	0.109

	0.103

	0.076

	0.055

	0.055

	0.084

	0.072

	0.185

	0.155

	0.076

	0.077

Figure I-1.  Lognormal probability plot of fenpyroximate field trial data for tomato.

Figure I-2.  Tolerance spreadsheet summary of fenpyroximate field trial data for tomato.

Figure I-3.  Lognormal probability plot of fenpyroximate field trial data for bell pepper.

Figure I-4.  Tolerance spreadsheet summary of fenpyroximate field trial data for bell pepper.

Figure I-5.  Lognormal probability plot of fenpyroximate field trial data for non-bell pepper.

Figure I-6.  Tolerance spreadsheet summary of fenpyroximate field trial data for non-bell pepper.

Vegetable, Cucurbit, Group 9:  Greenhouse Cucumber

The dataset used to establish a tolerance for fenpyroximate on cucumber consisted of greenhouse (or polytunnel) trial data representing application rate of 0.1 lb ai/A (1 application at 0.1 lb ai/A/application) with a 7-day PHI.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (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 that were entered into the tolerance spreadsheet are provided in Table I-2.

Because 6 of 9 trial sample results were below the combined LOQ (combined LOQ = 0.02 ppm), MLE procedures were needed to impute censored values.  Visual inspection of the lognormal probability plot (Figure I-7) and the results from the approximate Shapiro-Francia test statistic (Figure I-8) indicated that the dataset was reasonably lognormal.

ഀࣆȀỰ⒐싁摧䔮æ	̀Ĥ␱愁Ĥ摧烴¥

3

[

\

”

•

Ç

2

5

Z

[

\

e

ƒ

“

•

š

¨

©

Æ

Ç

É

è

é

ê

ë

ÿ

#

%

'

)

-

.

?

@

I

  h

  h

gd

gd

ô

gd

ô

ô

I

K

M

k

m

r

t

u

v

Š

‹

˜

™

h3

h3

 h3

h3

*s

t

u

gd3

ô

␃ഃࣆȀᥐ᪸

␃ഃࣆȀᥐ᪸

kdæ

kd)

㐀ۖĀ̊4㐃昀Ĵ

¶

¶

‚

¶

¶

‚

¶

¶

‚

¶

¶

‚

¶

¶

¶

¶

b	8

b	8

b	8

he

he

he

he

he

he

he

 h

 h

 h

 h

摧呥}	ԀĤ␆㄁Ĥ摧呥}

 h

  h

 h

 h

 h

H*  h

 h

 h

 h

 h

Ff

 h

 h

  h

 h

 h

  h

H*

 h

@

 h

 h

 h

ഀ׆Ā褐㄀Ĥ摧⭰þ

 h

 h

  h

 h

  h

 h

 h

 h

 h

 h

H*

 h

  h

 h

 h

 h

 h

 h

 h

 h

 h

he

he

he

he

g

i

j

~

n

0

@

h

i

 i

Œ

*

;

T

c

o

p

q

”

½

ì

í

$

$

 n

o

p

q

r

†

‡

½

ë

í

ï

ý

  h

 h

í

î

ï

ð

ñ

ò

ó

ô

õ

ö

÷

ø

ù

ú

û

ü

ý

ഀ׆Ā֠㄀Ĥ摧粭'

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

$

ഀ׆Ā褐㄀Ĥ摧歀Á

 h

D

 h

the point estimate of the 99th percentile rounds to the value 0.06 ppm (Figure I-8).  Because this value was the minimum value, 0.06 ppm is the recommended tolerance level for fenpyroximate on greenhouse cucumber.

Table I-2.	Residue data used to calculate tolerance for fenpyroximate on greenhouse cucumber.

Regulator:	EPA

Chemical:	Fenpyroximate

Crop:	Cucumber, greenhouse (MLE)

PHI:	7 days

App. Rate:	0.08-0.10 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 47439605

	Combined Residues of Fenpyroximate and its Z-isomer (ppm)

	0.030

	0.030

	0.009

	0.011

	0.013

	0.030

	0.014

	0.016

	0.018

Figure I- 7.  Lognormal probability plot of fenpyroximate field trial data for greenhouse cucumber.

Figure I- 8.  Tolerance spreadsheet summary of fenpyroximate field trial data for greenhouse cucumber.

Page   PAGE  1  of   NUMPAGES  33

Fenpyroximate	Summary of Analytical Chemistry and Residue Data	DP#:  354703