Document ID: EPA-HQ-OPP-2008-0003-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-04-23T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Date:	05/30/07    

 

	Subject:	Pyraclostrobin.  PP5E7014.  Amendment.  Petition for Tolerance
on	

		Belgian Endive.  Additional Discussion of Residue Data and Its Use For
Adjustment 

		of  Previous Tolerance Recommendation.  Request for Revised Sections B
and F. 

DP Barcode:	339733	Decision Numbers:

PC Code:	099100	MRID No.: 46713801

  

40 CFR 180.	582

	Chemical Class:	Strobilurins

	

	From:	Jerry B. Stokes, Chemist

		Reregistration Branch 4

		Health Effects Division (7509P)

	Through:	Susan V. Hummel, Senior Scientist

		Reregistration Branch 4

		Health Effects Division (7509P)

		

	To:	Barry O’Keefe

		Registration Branch 3

		Health Effects Division (7509P)

		Barbara Madden PM-5

		Risk Integration Minor Use, and Emergency Response Branch

		Registration Division (7505P)

		John Bazuin, PM-22

		Fungicide Branch

		Registration Division (7505P)

Executive Summary

The Interregional Research Project No. 4 (IR4) has submitted field trial
data for the use of pyraclostrobin (WDG) on Belgian endive (MRID
46713801) (PP#5E7014).  HED previously reviewed this data and issued a
document (D337807, J. Stokes, 03/30/07).  It has now come to the
attention of HED that application rates stated in several data tables
are incorrect.   IR4 has resubmitted a revised Section D with the
corrected tables. After several communications with the petitioner it is
clear that the 2X rate is to become the 1X label rate.  It has also come
to the attention of HED that most of the data (5 of 6 applications) was
collected using backpack sprayers instead of the proposed use directions
of a conveyer belt application.  Thus the submitted data are not
reflective of the proposed moving belt application.  HED has decided to
use only the data from the trials that used the backpack sprayers in
both the pre-cold storage and pre-forcing trays.  Therefore, using the
data from the CA02 and CA03 trials only, and applying these values in
the MRL Calculator, the CA Method recommended a tolerance of 11 ppm for
the combined residues of pyraclostrobin and its metabolite.  However,
since the residue data do not adequately reflect the proposed
application method, and may highly overestimate the residues that could
be expected with the conveyor belt application.   Therefore, HED cannot
recommend for the establishment of a tolerance in/on Belgian endive at
this time.  

If IR4 wants to continue with this Section 3 registration, then the
following are needed: 

Use directions in Section B must match the application method used in
Section D for residue data collection.

The tolerance proposal in Section F must be supported by the application
method used in Section D for residue data collection.

Additional residue data that adequately reflect the use direction in
Section B must be submitted. (HED recommends that the petitioner submit
a protocol for HED review and comments before any residue data
collection begins.)

Note:  Since the backpack sprayer would reflect the worse-case, HED can
support a Section 18 request with the residue data from CA02 and CA03
only.  A time-limited tolerance of 11 ppm in connection with a Section
18 request would adequately cover any pyraclostrobin using a backpack
sprayer application method.

860.1200 Directions for use.

It has come to the attention of HED that application rates in several
data tables (PP#5E7014 MRID 46713801, Belgian endive) are incorrect.  
IR4 has resubmitted a revised Section D with the corrected tables. 
Initially IR4 defined the 1X rate as 0.011 lb a.i./850 lb roots and the
2X rate as 0.022 lb a.i./850 lb roots.  After several communications
with the petitioner it is clear that the 2X rate is to become the 1X
label rate.  Also, the petitioner has informed HED that the 0.4 oz value
stated in the applications directions for the forcing trays should be
0.3 oz.   In addition, in the petitioner’s initial submission, the
values 850 and 875 (lbs roots) are interchanged in both text and data
tables.  HED suggests that data be reported as ……. per 100 lb of
roots.

HED recommends that the label rate be revised to clearly define the
amounts to be used per application and the total per season.  In
addition, the petitioner should define how the spray is applied to the
roots in the forcing trays (.i.e., trays are stationary or are moving on
conveyor belt). 

A revised Section B must be submitted to adequately reflect the
petitioner’s intentions as to application rates and directions.

Suggested label changes:

Prior to Cold Storage

“Make one……….. Apply 0.7 to 1.4 oz Pristine® fungicide in 2 to
2.5 gallons of water per 850 lbs roots.”

HED suggests that label should state the following:

“Make one……….. Apply 0.08 to 0.16 oz of Pristine® fungicide in
2 to 2.5 gallons of water per 100 lb of roots “

Prior to Forcing

“Make one……….. “Apply at the rate of  0.15 to 0.4 oz
Pristine® fungicide in approximately 3 quarts of water per 10 square
feet of forcing tray.   

HED suggests that label should state the following:

“Make one………..Apply the rate of  0.015 to 0.03 oz of Pristine®
fungicide in approximately 3 quarts of water per 1 square foot of
forcing tray.

  References

DP Barcodes:	337807, 327899, 337817, 338448

Subject:		PP#’s 5F7002 and 5E7014.  Petition for Tolerances on Cotton
and 	

		Belgian Endive, and An Increased Tolerance on the Berries Crop Group.
Submission 

		of Requested Field Trial Data on Mustard Greens (PP#3F6581).   
Submission of 		

		Additional Field Trial Data on Fruiting Vegetables (PP#0F6139),
Cucurbit 

		Vegetables (PP#0F6139), Sunflower (PP#2F6431), Mint (PP#2F6431), and 	

		Grape (PP#0F6139).  Summary of Analytical Chemistry and Residue Data. 

		(Reg. No. 7969-198):  

From:          Jerry Stokes

To:		Barry O’Keefe, Barbara Madden, John Bazuin

Dated:		03/30/07

MRIDs:      46512002, 46512003, 46637701, 46665501, 46665502, 46665504,
46665505, 

                 	46665506, 46685901, 46685902, 46713801

Appendix I:   International  Residue Limit Status sheet (1 page)

Appendix II  Tolerance Assessment Calculations (4 pages)

RDI:  SVHummel 05/30/07

Petition Number(s):  5E7014

DP Barcodes:  339733

PC Code:  099100

Appendix I  											

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  methyl
[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy
carbamate	Common Name:

Pyraclostrobin	( Proposed tolerances

( Reevaluated tolerance

No Codex proposal step 6 or above

(No Codex proposal step 6 or above for the crops requested 	Petition
Number: 5F7002, 5E7014

DP Barcode: 337807, 337817

Other Identifier: 

Residue definition (step 8/CXL):   	JStokes/HED/RRB4

	Residue definition: Combined residues of pyraclostrobin and BF 500-3,
expressed as parent

Crop (s)1	MRL (mg/kg)	Crop(s)	Proposed Tolerance (ppm)

Belgian endive	11.0

Limits for Canada	Limits for Mexico

( No Limits

( No Limits for the crops requested	( No Limits

(  No Limits for the crops requested

Residue definition:  	Residue definition:    

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

	Notes/Special Instructions:

Appendix II - Tolerance Assessment Calculations.					

The Agency’s Guidance for Setting Pesticide Tolerances Based on Field
Trial Data was utilized for determining appropriate tolerance levels for
Belgian endive as the combined residues of pyraclostrobin and BF 500-3
were readily quantifiable (>LOQ) in/on  this commodity. 

The datasets used to establish the crop group tolerance consisted of
field trial data representing applications of the appropriate
formulations at ~1/2 x (residue values doubled) and 1x the maximum
proposed use rates.  As specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP, the field trial application 1x
rates were within 25% of the maximum label application rate, and the
PHIs were consistent with the appropriate stage of maturity and the
proposed PHI for Belgian endive. 

 

The values for combined pyraclostrobin residues were used to calculate
the appropriate tolerances for Belgian endive (Table II-1)   The data
set for Belgain endive does not appear to be lognormal (Figure II-1). 
The calculated tolerance was 11.0 ppm for Belgian endive (Figure II-2). 



Appendix II											

Regulator:	EPA

Chemical:	pyraclostrobin

Crop:	Beligan endive

PHI:	19-21 days

App. Rate:	1/2x rate (doubled) + 1x rate

Submitter:	IR4

	Residues	LN(Residues)	Z-scores

	3.620	1.29	-0.85

	3.580	1.28	-1.43

	5.506	1.71	0.15

	5.806	1.76	0.47

	3.889	1.36	0.20

	3.721	1.31	-0.20

	7.962	2.07	1.28

	7.513	2.02	0.64

Appendix II											

Appendix II											

	Regulator:	EPA	 

	Chemical:	pyraclostrobin	 

	Crop:	Beligan endive	 

	PHI:	19-21 days	 

	App. Rate:	1/2x rate (doubled) + 1x rate	 

	Submitter:	IR4	 

	 

 

	n:	8	 

	min:	3.58	 

	max:	7.96	 

	median;	4.70	 

	average:	5.20	 

	 	 	 

	95th Percentile	99th Percentile	99.9th Percentile

EU Method I

Normal	9.0	10	11

	(11)	(13)	(--)

EU Method I

Log Normal	9.0	11	14

	(15)	(25)	(--)

EU Method II

Distribution-Free	 	#REF!	 

	 	 	 

California Method

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Ԁμ + 3σ	 	11	 

	 	 	 

UPLMedian95th	 	45	 

 	 

 

Approximate Shapiro-Francia Normality Test Statistic	 	0.7245	 

	 	p-value <= 0.01: Reject lognormality assumption	 

	 	 	 

 

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