Document ID: EPA-HQ-OPP-2008-0556-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-08-03T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		07-JUL-2009

Subject:	Fenpyroximate in/on Fruiting Vegetable (Crop Group 8), Melon
(Crop Subgroup 9A), Cucumber, and Okra.  Response to Risk Assessment 1
Branch (RAB1) Review of 17-MAR-2009 (DP# 354703).  

  SEQ CHAPTER \h \r 1 

PC Code:  129131	DP Barcodes:  D364908, D366715

Decision No.:  394796	Registration Nos.:  71711-4, 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 Nos.:  4773601, 4773602, 4773603, 47771301, 47771302, 47790601	40
CFR:  §180.566

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

		RAB1/Health Effects Division (HED) (7509P)

Through:	Dana M. Vogel, Branch Chief

		RAB1/HED (7509P)

To:		Sidney Jackson/Barbara Madden, PM Team 05

		Registration Division (RD) (7505P)

Executive Summary

Fenpyroximate is a contact insecticide/miticide used for the control of
leafhoppers, mealybugs, and mites.  U.S. registrations are currently
held by Nichino America, Inc. and include a 0.42 lb/gal (5%)
suspension-concentrate (SC; equivalent to a flowable-concentrate, FlC)
formulation (Akari® 5SC Miticide - Insecticide, EPA Reg. No. 71711-4),
registered for nonfood use on ornamental, floral, and foliage crops, and
a 0.40 lb/gal (5%) emulsifiable-concentrate (EC) formulation (FujiMite®
5 EC Miticide/Insecticide; EPA Reg. No. 71711-19) registered for foliar
application to pome fruit, cotton, grapes, and nonbearing deciduous
fruit and nut trees and vines. 

Data in support of this petition were originally reviewed by HED under
DP# 354703 (3/17/09, G. Kramer).  The current amendment addresses only
the deficiencies pertaining to OPPTS 860.1340 Residue Analytical Methods
identified in this review. 

Remaining Residue Chemistry Deficiencies Pertaining to OPPTS 860.1340
Residue Analytical Methods

None

Regulatory Recommendations

  SEQ CHAPTER \h \r 1 Pending submission of revised Sections B and F
(see Memo, G. Kramer, DP# 354703; 3/17/09), there are no residue
chemistry issues that would preclude granting unconditional
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

A risk assessment was previously completed for these proposed uses (DP#
285051; 8/26/03, M. Clock-Rust, et al.).  

 

DETAILED CONSIDERATIONS

860.1340 Residue Analytical Methods

Deficiency - 860.1340 Residue Analytical Method - Plant Commodities
(from Memo, G. Kramer, DP# 354703; 3/17/09)

(	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.

Petitioner's Response:  Submission of MRID 47790601 “Revision 1 to
Quantitation of Fenpyroximate Residues in Raw Agricultural and Processed
Commodities: Analytical Protocol” which includes instructions for
peppers, cantaloupe, and cucumber.

HED's Conclusion:  This now deficiency is resolved.  

Deficiency - 860.1340 Residue Analytical Method - Plant Commodities
(from Memo, G. Kramer, DP# 354703; 3/17/09)

(	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.

Petitioner's Response:  MRID 4773601 is a validation study of Method
AJW/03/1 which demonstrates acceptable recoveries in a variety of
commodities (apple, strawberry, peach, pear, plum, bean, cucumber,
pepper, and tomato) at the LOQ (0.01 ppm).

HED's Conclusion:  This deficiency is resolved.  Submission of Method
AJW/03/1 fulfills the requirement for a confirmatory method.

Deficiency - 860.1340 Residue Analytical Method - Plant Commodities
(from Memo, G. Kramer, DP# 354703; 3/17/09)

(	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.

Petitioner's Response:  The statements concerning fenpyroximate being
converted to the Z-isomer in the injector area of the gas chromatograph
are erroneous.  The statements should have instructed the analyst to
calculate total fenpyroximate as the sum of the two peaks (fenpyroximate
and the Z-isomer).  MRIDs 4773602 (pepper) and 4773603 (cantaloupe) are
rewrites of the residue studies which include the corrected language.

HED's Conclusion:  This deficiency is resolved.  

cc:  G. Kramer (RAB1)

RDI:  RAB1 Chemists (7/1/09)

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

Template Version November 2003

Fenpyroximate	Response to Previous HED Review	DP# D338871

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