Document ID: EPA-HQ-OPP-2009-0980-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-02-02T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

Date:	   August 31, 2010 

SUBJECT:	Fluazifop-P-Butyl.  Request for the Registration of a Reduced
Pre-Harvest Interval for Application of the Venture L End-Use Product on
Imported Potatoes.  Summary of Analytical Chemistry and Residue Data.

PC Code:  122809	DP Barcode:  372408 & 380010

Decision No.:  423996	Registration No.:  100-1001

Petition No.: 9E7651	Regulatory Action: New Use Registration

Risk Assessment Type: NA	Case No.: 2285

TXR No.: NA	CAS No.: 79241-46-6

MRID No.: Summary Table Provided Below 	40 CFR: 180.411

FROM:	Peter Savoia, Chemist

	Risk Assessment Branch V

	Health Effects Division (7509P)

		

THRU:	William H. Donovan, Ph.D., Chemist

	Risk Assessment Branch V

	Health Effects Division (7509P)

		

TO:	Kathryn Montague/Michael Walsh, RM

	Herbicide Branch 

	Registration Division (7505P)

		

MRID Summary Table

MRID No.	Study Type	Comments

47920401	860.1340 (Residue Analytical Method)	47920402.der.doc &
47920403.der.doc

47920402	860.1500 (potato)	47920402.der.doc

47920403	860.1500 (potato)	47920403.der.doc

47920404	860.1500 (reduced PHI for potato)	No separate der

47920405	860.1520 (potato)	47920405.der.doc

Prior actions made to develop the fluazifop-P-butyl herbicide active
ingredient (ai) have identified a number of studies that are required
for completing data gaps.  In accordance, a number of Data Call-In (DCI)
submissions have been provided by the registrant in order to satisfy
these database requirements.  These studies are as follows:

• Carrot and endive nature of residue studies, test guideline
860.1300. 

• Ruminant and poultry nature of residue studies, test guideline
860.1300. 

• Radiovalidation study made for the tolerance enforcement method
proposed for analyzing plants,                         test guideline
860.1340. 

• Method validation study made for the tolerance enforcement method
proposed for analyzing poultry, eggs and livestock, test guideline
860.1340.

• Cattle and poultry feeding studies, test guideline 860.1480.

• Confined rotational crop study, test guideline 860.1850. 

In all, an assessment of these studies is currently in progress and will
be addressed in a separate memorandum in due course.  Should the results
of the studies submitted in response to the registration DCI impact the
conclusions reached in this summation, appropriate changes will be made
at that time.  No further discussion of these in review studies will be
included in this memorandum.

Executive Summary

  SEQ CHAPTER \h \r 1 Fluazifop-P-butyl
[(R)-2-(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy)propanoic acid,
butyl ester] is a selective herbicide registered for postemergence
control of perennial and annual grass weeds.  It   SEQ CHAPTER \h \r 1
is the resolved isomer (R enantiomer) of fluazifop-butyl
[(R,S)-2-(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy) propanoic
acid, butyl ester].  After application fluazifop-P-butyl is rapidly
hydrolyzed to fluazifop acid (R enantiomer) where it accumulates in the
meristems of grass weeds working to interrupt lipid synthesis in
susceptible plants.  Fluazifop-P-butyl end-use products are registered
in the United States to Syngenta Crop Protection, Inc. under the trade
names Fusilade®, Fusion®, Oramec®, Tornado®, and Typhoon®.   

This herbicide active ingredient is the resolved isomer (R enantiomer)
of fluazifop-butyl (PC code 122805) which has since been cancelled
resulting in only fluazifop-P-butyl to be supported for re-registration.
 The Residue Chemistry Chapter of the   SEQ CHAPTER \h \r 1
Fluazifop-P-Butyl TRED (referred to herein as the Residue Chapter) was
issued on August 17, 2005 (DP No. 319907, S. L. Kinard, 08/17/2005).  It
provided   SEQ CHAPTER \h \r 1 the Residue Chemistry Assessments that
went into the “Report on FQPA Tolerance Reassessment Progress and
Interim Risk Management Decisions (TRED) for fluazifop-P-butyl.”

In the current petition, Syngenta Crop Protection, Inc. requests the
establishment of a tolerance for the residues of fluazifop-P-butyl in/on
imported potatoes and its processed commodities:

Potato, tubers	1.1 ppm

Potato, wet peel	1.1 ppm

Potato, chips	3.0 ppm

Potato, granules/flakes	5.0 ppm

The end-use products relevant for this petition request are the VENTURE
L and Fusilade® MAX(X) herbicide Emulsifiable Concentrate (EC)
formulations.  These end-use products are identical with both of them
containing approximately 14.0% fluazifop-P-butyl active ingredient (ai)
equivalent to 125 g ai/L.  For this action, Syngenta has requested to
amend the label of the VENTURE L product by adding this new use on
potatoes.  In addition, the registrant is requesting that the
application instructions also be amended to allow for treatments to be
made at the late seasonal timed Pre-Harvest Interval (PHI) of 45 days. 
Treatments of these products are to be made as a single foliar spray
application not to exceed the maximum labeled rate of 250 g ai/ha timed
at a PHI of 45 or 90 days.  

Fluazifop-butyl isomers are List B chemicals with parent and
fluazifop-acid (free and conjugated) regulated for tolerance expression
as the residues of concern used to determine misuse (DP No. D319907, S.
L. Kinard, 08/17/2005).  Its registered uses include dry beans, carrot,
cotton, endive (escarole), macadamia nut, onion, peanut, pecan, soybean,
spinach, stone fruit, and sweet potato.  It also carries tolerances with
regional registrations on asparagus, coffee, pepper, and rhubarb along
with being registered for use on lawns as a weed control application. 
Tolerances are established under 40 CFR §180.411(a)(1) and (c)(1) for
residues of fluazifop-butyl, including free and conjugated fluazifop,
expressed as fluazifop.  For fluazifop-P-butyl, including free and
conjugated fluazifop (R isomer), tolerances are likewise established
under 40 CFR §180.411(a)(2) and (c)(2) with residues expressed as
fluazifop.

The nature of the residue in both plants and livestock cannot yet be
described as adequately understood.  For the current action, an
acceptable soybean metabolism study is available, and the soybean
metabolism study will also support the proposed uses on the other crops
addressed herein.  The Metabolism Assessment Review Committee (MARC)
concluded that the residues of concern for tolerance expression for
plants and animals are parent and fluazifop-acid (free and conjugated)
since they are adequate to determine misuse.  The MARC also concluded
that the residues of concern in plants for risk assessment are parent,
fluazifop-acid (free and conjugated), 5-trifluoromethyl-2-pyridone, and
2-(4-hydroxyphenoxy) propionic acid (free and conjugated).  The residues
of concern in animals for risk assessment are parent and fluazifop-acid
(free and conjugated) (DP No. D298939, S. L. Kinard, 6/22/2004).

There are adequate residue analytical methods listed in PAM II for
tolerance enforcement and data collection.    SEQ CHAPTER \h \r 1 For
the enforcement of tolerances for fluazifop-P-butyl residues of concern,
a High Performance Liquid Chromatography/Ultra-Violet Spectrometry
(HPLC/UV) method is available for crop commodities.  In conjunction,
HPLC/UV and Gas Chromatography/Mass Spectrometry (GC/MS) methods are
available for milk and animal commodities.  The stated quantitation
limits are 0.02-0.05 ppm for crop commodities, 0.01 ppm for milk, and
0.02 ppm for animal tissues.  In addition, the FDA PESTDATA database
dated 11/01 (PAM Volume I, Appendix I) indicates that fluazifop-butyl
(only) is completely recovered using Multiresidue Methods Sections 302
(Luke Method; Protocol D) and 303 (Mills, Onley, and Gaither Method;
Protocol E, nonfatty food).  

To support this petition, the field trial samples were analyzed for
residues of total fluazifop using a High Performance Liquid
Chromatography/Mass Spectrometry/Mass Spectrometry (HPLC/MS/MS)
protocol.  This procedure is a common moiety method which works by
hydrolyzing the fluazifop ester or acid conjugates so that a total
determination can be made.  This protocol is adequate for data
collection based upon acceptable method validation and concurrent method
recoveries.  The validated Limit of Quantitation (LOQ) verified in
potatoes is 0.010 ppm for this method.

The proposed new uses included in this petition will request the
establishment of tolerances on potato crops which are commonly
recognized as being livestock feedstuffs.  Given that these uses will be
established on imported commodities, residues of fluazifop-P-butyl in/on
potatoes will not result in being a contributor to the dietary burden of
cattle.  In accordance, it will not be necessary to provide a
re-calculation of dietary burden in support of this action.  The
conclusions determined for the secondary transfer of fluazifop-P-butyl
residues to meat, milk, poultry, and eggs made prior for the pending
uses established on dry beans and peanuts remain current.

The submitted field trial data are adequate to support the proposed
seasonal use pattern demonstrated on potatoes.  The maximum residues of
total fluazifop were 0.61 ppm in/on potatoes harvested at a PHI of 45
days following a single broadcast foliar application of the 250 g ai/ha
EC formulation made at the 1x seasonal rate.  These results demonstrate
the application of the fluazifop-P-butyl herbicide made on potatoes
within the various geographic/climatological production regions of
Canada.  The number and location of field trials were sufficient in
scope since they were undertaken in line with the requirements set forth
in the PMRA Regulatory Directive to evaluate this use.  In accordance,
MRID No. 47920402 contains 13 field trials and MRID No. 47920403
provides an additional 3 more to satisfy the Canadian requirement for a
total of 16 studies in all.  The field trial data were entered into the
NAFTA tolerance/MRL spreadsheet which determines that a recommended
tolerance of 1.0 ppm is appropriate for regulating residues of
fluazifop-P-butyl in/on potatoes.

The submitted processing study is adequate in providing a determination
of residue concentration factors for fluazifop-P-butyl in potato
processed commodities.  Processing of the potato Raw Agricultural
Commodity (RAC) bearing quantifiable residues of fluazifop resulted in
no concentration of residues in the peel (1.1x processing factor). 
However, total fluazifop residues were found to concentrate in the
potato cooked product, chips and dried flakes at a processing factor of
1.4x, 3.3x, and 6.4x, respectively.  These data, along with the Highest
Average Field Trial (HAFT) residue, indicate that a tolerance limits are
needed for fluazifop-P-butyl residues of concern in potato chips at 2.0
ppm and granules/flakes at 4.0 ppm.  

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

Provided that a revised Section F is submitted, there no residue
chemistry issues that would preclude establishing tolerance limits for
the use of fluazifop in/on potatoes.  The proposed uses and the
submitted data support the following tolerances for total fluazifop
residues (fluazifop-P-butyl and free and conjugated fluazifop-P)
expressed as fluazifop, in/on:

Potato	1.0 ppm

Potato, chips	2.0 ppm

Potato, granules/flakes	4.0 ppm

A new human health risk assessment which includes potatoes is
forthcoming in a separate document.

860.1200 Directions for Use

The submitted bridging study data made for the Venture L and Fusilade
Maxx EC formulations show that when they are applied to potatoes at 1x
the maximum seasonal rate, the resulting residues will be similar.  If
the registrant so chooses, a revised section B could be submitted which
includes this use for both product formulations.  

860.1380 Storage Stability

Adequate storage stability data are available to support sample storage
conditions incurred for the potato RAC, but none have been provided for
the processed commodities.  This is required since the processed
commodities do not appear to have been analyzed within thirty (30) days
of production.

860.1550 Proposed Tolerances

The proposed tolerances should be revised to reflect the recommended
tolerance levels and correct commodity definitions as specified in Table
8.  

Background

Fluazifop-P-butyl
[(R)-2-(4-((5-(trifluoromethyl)-2-pyridinyl)oxy)phenoxy)propanoic acid,
butyl ester] is a selective herbicide used for the post-emergence
control of perennial and annual grass weeds.  It is the resolved isomer
(R enantiomer) of fluazifop-butyl (PC code 122805) which has since been
cancelled resulting in only fluazifop-P-butyl to be supported for
re-registration.  The fluazifop-butyl isomers are List B chemicals with
parent and fluazifop-acid (free and conjugated) regulated for tolerance
expression as the residues of concern used to determine misuse (DP No.
D319907, S. L. Kinard, 08/17/2005).  T  SEQ CHAPTER \h \r 1   SEQ
CHAPTER \h \r 1 he Phase 4 Reviews for fluazifop-butyl and
fluazifop-P-butyl were completed on 02/26/1991.  The subsequent Phase 5
review of these studies has also been completed as well.  This includes
the Residue Chemistry Science Assessments with respect to the Report on
FQPA Tolerance Reassessment Progress and Interim Risk Management
Decisions (TRED) for fluazifop-P-butyl issued on 08/17/2005.  For
review, the chemical structure and nomenclature of fluazifop-P-butyl,
including its free acid fluazifop-P as well as the physicochemical
properties of the technical grade of fluazifop-P-butyl are presented
below in Tables 1 and 2. 

  

 

Common name	Fluazifop-P (free acid)

Chemical name	  SEQ CHAPTER \h \r 1
(R)-2-(4-[5-(trifluoromethyl-2-pyridinyl)oxy]phenoxy)propionic acid

Table 2.      Physicochemical Properties of Fluazifop-P-butyl. 

Parameter	Value	Reference1

Melting point/range	  SEQ CHAPTER \h \r 1 Decomposes at 210 ºC

164 ºC at 0.02 mm Hg	  SEQ CHAPTER \h \r 1 2002 Farm Chemicals Handbook

RCB No. 1674, 2/3/87, L. Cheng

pH	  SEQ CHAPTER \h \r 1 Not dispersible in water	  SEQ CHAPTER \h \r 1
RCB No. 1674, 2/3/87, L. Cheng

Density	  SEQ CHAPTER \h \r 1 1.22 g/cc (PAI) and 1.20 g/cc (T) at 20
ºC	  SEQ CHAPTER \h \r 1 RCB No. 809, 6/3/86, L. Cheng

Water solubility	  SEQ CHAPTER \h \r 1 1 mg/L	  SEQ CHAPTER \h \r 1 RCB
No. 1674, 2/3/87, L. Cheng

Solvent solubility	  SEQ CHAPTER \h \r 1 Soluble in most organic
solvents

>500 g/L in acetone, dichloromethane, ethyl acetate, hexane, methanol,
toluene, and xylene	  SEQ CHAPTER \h \r 1 2002 Farm Chemicals Handbook

RCB No. 1674, 2/3/87, L. Cheng

Vapor pressure	  SEQ CHAPTER \h \r 1 3 x 10-8 KPa at 20 ºC	  SEQ
CHAPTER \h \r 1 RCB No. 809, 6/3/86, L. Cheng

Dissociation constant, pKa	  SEQ CHAPTER \h \r 1 -3.1 (by calculation)	 
SEQ CHAPTER \h \r 1 RCB No. 809, 6/3/86, L. Cheng

Octanol/water partition coefficient, Log(KOW)	  SEQ CHAPTER \h \r 1 4.5
at 20 ºC	  SEQ CHAPTER \h \r 1 RCB No. 809, 6/3/86, L. Cheng

UV/visible absorption spectrum	  SEQ CHAPTER \h \r 1 Not available

	1DP No. D348246, D. Soderberg, 09/16/2008

860.1200  Directions for Use

A summary of the proposed/amended use patterns for cultivating potatoes
are presented in Table 3.  The information presented in Table 3 was
obtained from a specimen label provided by Syngenta for the Venture L ®
Herbicide (Canadian Reg. No. 21209).

Table 3.      Summary of Directions for Use of Fluazifop-P-butyl.

Applic. Timing, Type, and Equip. 	Formulation

[EPA Reg. No.]	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(g ai/ha)	PHI

(days)	Use Directions and Limitations

Potato

Postemergence

Ground	Venture L®  Herbicide,

125 g ai/L EC

[21209]	1	250	45	May be mixed with Lexone or sencore formulations for
early post emergent application. 

The general label use directions specify that the Venture L herbicide
will be less effective when weeds are not growing rapidly because of
stress from lack of moisture, excessive moisture, flooding, low
temperature and/or very low humidity.  Treatments should be applied to
actively growing grass weeds that have 3 to 5 fully developed leaves for
best results.  Spray mist and drift is to be avoided with applications
never to be made by aircraft or within 15 m of fish bearing waters.  The
use of adjuvants (crop oil concentrate, non-ionic surfactant, or other
approved adjuvants) plus liquid nitrogen fertilizer may be used on
specified crops such as soybeans and potatoes.  

Conclusions:  The label directions are adequate to allow evaluation of
the residue data relative to the proposed use on potatoes.  

860.1300 Nature of the Residue - Plants

Residue Chemistry Memo, DP No. D319907, 08/17/2005, S. L. Kinard (TRED
Residue Chemistry Chapter)

HED MARC Decision Memo, DP No. D298939, 06/22/2004, S. L. Kinard

The Fluazifop-P-Butyl Residue Chapter of the TRED (DP No. 319907, S. L.
Kinard, 08/17/2005) concluded that the nature of the residue in soybeans
is adequately understood.  No new plant metabolism studies for the
proposed new use crops were submitted as part of the current petition. 
The MARC has determined that for tolerance expression, parent and
fluazifop-acid (free and conjugated) are the residues of concern since
they are adequate to determine misuse.  The MARC also concluded that the
residues of concern in plants for risk assessment are parent,
fluazifop-acid (free and conjugated), 5-trifluoromethyl-2-pyridone, and
2-(4-hydroxyphenoxy) propionic acid (free and conjugated).  

860.1300 Nature of the Residue - Livestock

The MARC has concluded that for tolerance expression and risk
assessment, parent and fluazifop-acid (free and conjugated) are the
residues of concern since they are adequate to determine misuse.   SEQ
CHAPTER \h \r 1 

860.1340 Residue Analytical Methods

Residue Chemistry Memo, DP No. D319907, 08/17/2005, S. L. Kinard (TRED
Residue Chemistry Chapter);

47920401.der.doc, Residue Analytical Method – Potato;

47920402.der.doc & 47920403.der.doc, Crop Field Trial /Residue Decline
– Potato;

479204005.der.doc, Processed Food & Feed - Potato

Enforcement methods

  SEQ CHAPTER \h \r 1 For the enforcement of tolerances for
fluazifop-P-butyl residues of concern, PAM Vol. II lists two methods,
Method I for animal tissues and milk and Method II for oily and non-oily
crops.  The stated detection limits are 0.02-0.05 ppm for crops, 0.01
ppm for milk, and 0.02 ppm for animal tissues.  In Method I, samples
(except fat) are extracted with acetonitrile/acetone/hexane, which
separates residues of fluazifop and fluazifop-butyl (found in the
acetonitrile/acetone layer) from residues of fluazifop lipophilic
conjugates (found in the hexane layer).  Fluazifop and fluazifop-butyl
are determined in milk using an HPLC/UV instrumental technique.  In
tissue samples, fluazifop-butyl is converted to fluazifop via
hydrolysis, and then its residues are methylated using diazomethane, and
determined by GC/MS.  Fluazifop lipophilic conjugates (for both milk and
tissue samples) are cleaned up by florisil chromatography, hydrolyzed to
fluazifop, and determined by HPLC/UV.  For fat, samples are extracted
with chloroform/methanol at reflux (2 hours) and residues of fluazifop,
fluazifop-butyl, and lipophilic conjugates are hydrolyzed to fluazifop,
methylated, and determined by GC/MS.

For Method II, residues of fluazifop-butyl, fluazifop, and any ester or
acid conjugates are extracted from crop samples using acetonitrile and
hydrochloric acid.  Residues are then hydrolyzed to fluazifop and
cleaned up using a coagulation procedure, solvent partitioning, and
silica column chromatography for determination by HPLC/UV.  Residues may
be confirmed by GC/MS following methylation with diazomethane. 
Consequently, neither of the enforcement methods distinguishes the
optical isomers of fluazifop-butyl or fluazifop.

  SEQ CHAPTER \h \r 1 Data collection methods (MRID No. 47920401) 

For this petition, field trials acquiring samples of potato tubers were
analyzed for residues of total fluazifop (fluazifop-P-butyl, fluazifop
free and conjugated) using an HPLC/MS/MS protocol.  This procedure
entitled, “Fluazifop-P-Butyl: Residue Analytical Method for Total
Fluazifop Analysis in Crops (Bolygo 1998)”, is denoted as Zeneca
Method RAM 287/02.  It is a common moiety method used for data
collection which works by hydrolyzing the fluazifop ester or acid
conjugates so that a total determination can be made.  A complete copy
of the original method, including any modifications made to this
procedure, was included in the submission.  Likewise, a formal copy of
the Zeneca RAM 287/02 protocol was also submitted as MRID No. 47920401
to support this petition requesting a fluazifop-P-butyl import tolerance
be established in/on potatoes.  

Method validation was conducted prior to the analysis of field samples
using a series of blanks and untreated potato samples fortified at 0.01,
0.05, and 0.10 ppm.  In doing so, the reported LOQ of 0.01 ppm was
demonstrated as being achievable in potatoes when using this method. 
Following the criterion of obtaining a minimal response of 3:1
signal/noise, the Limit of Detection (LOD) was thus established at
0.00330 ppm based upon fortifications analyzed at 3x below the LOQ.  In
addition, the performance of the method was likewise continuously
monitored throughout this study by analyzing a series of blanks and
fortified controls along with each analytical batch of samples.   

Samples of the potato RAC and its processed commodities were analyzed
for total residues of fluazifop (fluazifop-P-butyl, fluazifop free and
conjugated) using a GC/MS protocol.  This procedure entitled,
“Gaschromatograpische Bestmmung von Fluazifop und Fluazifop-P-butyl in
Pflanzlichem Material”, is denoted as laboratory test protocol
P-14.077.  It is a common moiety method which works by forming the
methyl ester of fluazifop through extraction so that a total
determination can be made.  A detailed summary of the original method
was provided within the submission.

The validated LOQ for this methodology is 0.01 ppm for fluazifop-P-butyl
expressed as total fluazifop in all potato matrices.  It is based upon
the analysis of untreated samples fortified with fluazifop-P-butyl
worked up concurrently with the determination of the treated unknowns. 
The validated LOQ is therefore defined as the lowest fortification level
yielding acceptable recoveries (70–120 % R) at analysis.  In addition,
method performance was also monitored throughout the study by analyzing
a series of blanks and fortified controls along with each analytical
batch of samples.

Conclusions.  The existing GC/MS enforcement method, or this modified
version, is adequate for collecting data on residues of fluazifop in/on
potato commodities.  It is adequate for enforcing tolerances on these
commodities.  The data collection methods used by the registrant were
likewise shown to be adequate for determining the magnitude of fluazifop
residues in potato commodities acquired in support of this petition.  

860.1360 Multiresidue Methods

Residue Chemistry Memo, DP No. 319907, 08/17/2005, S. L. Kinard (TRED
Residue Chemistry Chapter)

  SEQ CHAPTER \h \r 1 The FDA PESTDATA database dated 11/01 (PAM Volume
I, Appendix I) indicates that fluazifop-butyl is completely recovered
using Multiresidue Methods Sections 302 (Luke Method; Protocol D) and
303 (Mills, Onley, and Gaither Method; Protocol E, nonfatty food);
recovery using Section 304 (Mills Method; Protocol F, fatty food) is
variable.

860.1380 Storage Stability

Storage stability data have been reviewed in conjunction with earlier
actions undertaken for fluazifop-P-butyl which indicate that its
residues are stable in a wide variety of crop commodities.  As such, its
stability in frozen potatoes has previously been investigated in prior
reports generated by Syngenta.  These reports show that fortified
potatoes demonstrate no loss of fluazifop-p-butyl when stored frozen at
-18°C for 18 months (DP No. D348246, D. Soderberg, 09/16/2008).  Given
the results obtained from the prior stability study made on potatoes,
adequate data are available to support the sample storage intervals and
conditions incurred in the field trial submissions.  Although adequate
data are available to support sample storage conditions of the potato
RAC, none were provided to substantiate the holding times that were
incurred for the processed commodities.  This is required since the
processed commodities do not appear to have been analyzed within thirty
(30) days of production.  A summary of the storage durations and
conditions of the samples from the crop field trials and processing
studies provided to support this petition are presented below in Table 4
for review.  

Table 4.      Summary of Storage Conditions.

Matrix	Storage Temperature (°C)	Actual Storage Duration1 

	Interval of Demonstrated Storage Stability

Potato/

≤-10 °C	63-142 days

(2.1-4.7 months)	5482 - Total fluazifop residues appear relatively
stable under frozen conditions in/on potatoes for up to 18 months.

Potato/

MRID No. 47920403	≤-10 °C	94-142 days

(3.1-4.7 months)	5482 - Total fluazifop residues appear relatively
stable under frozen conditions in/on potatoes for up to 18 months.

Potato Processing/

MRID No. 47920402	Tuber	≤-18 °C	200 days (6.7 months)	5482 - Total
fluazifop residues appear relatively stable under frozen conditions
in/on potatoes for up to 18 months.

	Peel

	None.

	Cooked

Chips

Granules/Flakes

	1  Actual storage duration from harvest to analysis.

2  DP No. 348246, D. Soderberg, 09/16/2008.

Conclusions:  Previously submitted storage stability data demonstrate
that total residues of fluazifop-P-butyl are stable in/on variety of
crops which include the potato RAC.  These data are adequate in
supporting all of the potato RAC sample storage conditions and durations
that were incurred for testing relevant to this petition request
(PP#9E7651).  However, no data were provided to substantiate the holding
times that were incurred for any of the potato processed commodities
which were analyzed.  Given that none of the processed potato fractions
appear to have been analyzed within thirty (30) days of production,
additional stability data may be required for these commodities.

860.1400 Water, Fish, and Irrigated Crops

For the purpose of this summary, this guideline requirement is not
relevant to this evaluation since   SEQ CHAPTER \h \r 1
Fluazifop-P-butyl has no registered or proposed uses on water or aquatic
food and feed crops.

860.1460 Food Handling

For the purpose of this summary, this guideline requirement is not
relevant to this evaluation since   SEQ CHAPTER \h \r 1
Fluazifop-P-butyl has no food-handling uses which are being proposed.

860.1480 Meat, Milk, Poultry, and Eggs

Residue Chemistry Memo, DP No. D348246, 09/16/2008, D. Soderberg
(PP#7F7289 Residue Chemistry Chapter)

In evaluating the data provided to support this petition, the
establishment of tolerance limits will be recommended for several RACs
commonly recognized for use as livestock feedstuffs.  This would include
establishing tolerance limits for citrus dried pulp and sugar beet tops
which are requested in part with this action.  The maximum theoretical
dietary burdens to livestock were previously evaluated in the prior
residue chemistry chapter prepared to support pending uses on dry beans
and peanuts (DP No. D348246, D. Soderberg, 09/16/2008).  The resulting
theoretical dietary burdens of fluazifop-P-butyl to livestock were put
forward with the updated version of Table 1 (Table 1 Feedstuffs June
2008) and are presented below in Table 5 for review.

Table 5.   Calculation of Dietary Burdens of Fluazifop-P-butyl Residues
to Livestock.

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

Beef Cattle

Soybean, hulls	R	90	20	2.5	0.555

Untreated CC	CC	NA	65	NA	0

Soybean, meal	PC	92	15	2.5	0.408

TOTAL BURDEN	--	--

--	0.963

Dairy Cattle

Soybean, hulls	R	90	15	2.5	0.417

Untreated R	R	NA	30	NA	0

Carrot, culls	CC	12	10	2.0	1.667

Untreated CC	CC	NA	35	NA	0

Soybean, seed	PC	89	15	2.5	0.421

TOTAL BURDEN	--	--

--	2.505

Poultry

Untreated CC	CC	NA	75	NA	0

Soybean, meal	PC	--	25	2.5	0.625

TOTAL BURDEN	--	--

--	0.625

Swine

Untreated CC	CC	NA	85	NA	0

Soybean, meal	PC	--	15	2.5	0.375

TOTAL BURDEN

	--	--	0.375

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 Fluazifop-P-butyl have not
been registered or proposed for this feedstuff. 

These calculations are considered tentative because plant and animal
metabolism studies remain outstanding and additional field trials are
required for some crops.  It was also noted that there are label
restrictions against the grazing or harvesting of peanut hay as well as
soybean forage and hay which are appropriate according to Table 1 of
860.1000.  In all, the addition of the use on peanut did not affect the
theoretical dietary burden of fluazifop residues to livestock.  Soybeans
were found to have a larger impact and these matrices were incorporated
into the previous dietary burden calculations.  The effect of use on
cowpea forage and hay along with residues on the soybean aspirated grain
fractions will be evaluated after these data have been submitted.  Prior
calculated dietary burden maximums of fluazifop-P-butyl were reported to
beef/dairy cattle at 4.49 ppm, 1.00 ppm to poultry, and 0.70 ppm to
swine.  These differ significantly from the updated values presented in
Table 5 due to the current calculations being based on a “reasonably
balanced” diet and the reduction in the diet percentage for carrot
culls.

  

Nonetheless, in assessing the new uses pursuant to this petition, potato
crops are commonly recognized as being livestock feedstuffs.  Given that
these uses will be established as import tolerances, residues of
fluazifop-P-butyl in/on potatoes will not result in being a contributor
to the dietary burden of cattle.  As a result, it will not be necessary
to provide a re-calculation of dietary burden in support of this action.
 The prior calculations tentatively depicting the secondary transfer of
fluazifop-P-butyl residues to meat, milk, poultry, and eggs made for the
pending uses established on dry beans and peanuts remain current.

Conclusions:  No change in the tolerances of meat, milk, poultry, and
eggsis needed at this time.  

860.1500 Magnitude of the Residue in Crops

DER References:  47920402.der.doc (potato – 13 trials)

		47920403.der.doc (potato – 3 trials)

		

For this current petition, Syngenta is requesting that a new import
tolerance for the residues of fluazifop-P-butyl in/on potatoes and its
processed commodities be established.  To satisfy data requirements,
field trial studies have been made on potatoes within the various
geographic/climatological production regions of Canada and submitted by
the registrant to support this petition.  The number and location of
field trials were sufficient in scope since they were undertaken in line
with the requirements set forth in the PMRA Regulatory Directive to
evaluate this use.  In accordance, MRID No. 47920402 contains 13 field
trials and MRID No. 47920403 provides an additional 3 more to satisfy
the Canadian requirement for a total of 16 studies in all.  A summary of
the residue data acquired from these field trial studies which were
undertaken are presented below in Table 6.

Table 6.	      Summary of Residue Data from Crop Field Trials with
Fluazifop-P-butyl.

Commodity	Total Rate

 (g ai/ha)	PHI (days)	End-Use Product	Residue Levels

 (ppm)

n	Min.	Max.	HAFT1	Median2

(STMdR)	Mean2

(STMR)	Std. Dev.2

Potato	0.250	44-46	Venture L	32	< 0.0033	0.61	0.55	0.065	0.11	0.13

1  HAFT = Highest Average Field Trial.

2 For mathematical purposes, in the calculation of the median, mean, and
standard deviation, 0.00165 ppm (half the LOD) was used for             
                                                             residues
reported as less than the LOD (<0.0033 ppm).

3 Not Applicable (NA).

Potatoes (MRID No. 47920402)

To determine the magnitude of fluazifop-P-butyl residue found in/on
potatoes within the various production regions of Canada, thirteen (13)
field trials were conducted during the 2008 growing season.  The
thirteen (13) field trials held for this study were carried out in
Canadian growing zones 1, 1A, 5, 5B, 7A, 12 and 14 all of which are
known to be significant potato cultivation regions of the country.  As
such, two trials were held at New Glasgow, Elm Creek, and Malden along
with single ones made at Albany, Branchton, St. Marc-sur-Richeilieu,
Taber, Abbotsford, Minto, and Innisfall.  Each trial site was managed
according to the practices routinely followed by Canadian commercial
producers for cultivating potatoes.  Test plots were roughly 10-100
square meters in size, large enough to provide a 1 Kg sample of mature
potato tubers to be collected from at least six (6) different plants.   

At each study location, market quality potato samples were cultivated
using both untreated control and treated test plots.  Each treated test
plot received a single application of the VENTURE L end-use product made
at the maximum labeled rate of 250 g ai/ha so that late seasonal
treatments could be evaluated.  In doing so, this comparison will
provide sufficient data to support establishing a Pre-Harvest Interval
(PHI) of 45 days in addition to currently registered early seasonal
treatments made at 90 days.  The actual rate of application ranged from
94.2% to 103.4% of the targeted amount of product designated for
treatment.  The treatment regimen also included two (2) residue decline
studies made at the New Glasgow and Elm Creek sites with samples
collected at -7, 0, +7, +14 and +21 days of normal commercial harvest. 
The application procedure followed was typical of the local agricultural
practices with treatments being made using either tractor-mounted or
hand-held boom sprayers.  No adjuvant was added to the spray mixture for
any of the applications.      

To perform the determination of total fluazifop residues in/on potatoes,
an acceptable method was used and adequate data are available to support
the sample storage durations of up 143 days that were incurred.  Total
residue levels were observed ranging at levels between <0.0033 - 0.61
ppm for treatments made at the late seasonal timed PHI of 45 days (± 1
day) using the VENTURE L formulation of fluazifop.  The results
generated in the two decline studies illustrate demonstrate that
concentrations of fluazifop will in fact decrease as greater PHIs for
treatment are followed.  In all, these data are adequate to support the
proposed seasonal use pattern on potatoes put forward in this study.  A
summary of the residue data obtained from the potato field trials made
for this study are presented below in Table 7 for review.

Table 7.      Residue Data from Crop Field Trials with Fluazifop-P-butyl
Presented in MRID No. 47920402.

Trial:  City, Province; Year

(Trial ID #)	Zone	Potato; Variety	# of Treatments	 Total Rate 

(g ai/ha)	PHI 1

 (days)	End-Use Product	Total

Fluazifop

(ppm)

New Glasgow, PEI; 2008 (T455)	1A	Shepody	1	250	46	Venture L	0.16, 0.08

Albany, PEI; 2008 (T456)	1A	Carlingford	1	250	36	Venture L	< LOD2, <LOD

New Glasgow, PEI; 2008 (T457 – Decline Study)	1A	Goldrush	1	250	39
Venture L	0.28

	46

0.61, 0.49

	53

0.32

	60

0.37

	68

0.34

Malden, NB; 2008 (T458)	1	Red Norland	1	250	46	Venture L	0.035, 0.036

Malden, NB; 2008 (T459)	1	Goldrush	1	250	46	Venture L	0.27, 0.28

Branchton, ON; 2008 (T460)	5	Goldrush	1	250	45	Venture L	< LOQ3
(0.0070), 0.016

Elm Creek, MB; 2008 (T461 – Decline Study)	5	Shepody	1	250	37	Venture
L	0.020

	44

0.016, 0.012

	51

0.024

	58

< LOQ (0.0070)

	65

0.020

Elm Creek, MB; 2008 (T462)	5	Russet Burbank	1	250	44	Venture L	< LOQ
(0.0052), 0.036

St. Marc-sur-Richelieu, QC: 2008 (T463)	5B	Kennebec	1	250	45	Venture L
0.044, 0.037

Taber, AB; 2008 (T464)	7A	Russet Burbank	1	250	46	Venture L	0.14, 0.20

Abbotsford, BC; (T465)	12	WanBa	1	250	44	Venture L	0.043, 0.035

Minto, MB; 2008 (T466)	14	Norland	1	250	46	Venture L	0.14, 0.16

Innisfall, AB; 2008 (T467)	14	Russet Burbank	1	250	45	Venture L	0.065,
0.050

1  PHI = Preharvest interval; interval from last application to harvest
(petitioner reported PHI based on collection date).

2  LOD = Limit of Detection; 0.0033 ppm.

3  LOQ = Limit of Quantitation; 0.01 ppm.

Potatoes (MRID No. 47920403)

To determine the magnitude of fluazifop-P-butyl residue found in/on
potatoes within the various production regions of Canada, three (3)
field trials were conducted during the 2007 growing season.  The three
(3) field trials were held at Hunter River (2 trials) and Portage la
Prairie (1 trial) in Canada all of which are located in significant
potato growing regions of the country.  Each trial site was managed
according to the practices routinely followed by Canadian commercial
producers for cultivating potatoes.  Test plots were roughly 40-45
square meters in size, large enough to provide a 1 Kg sample of mature
potato tubers to be collected from at least six (6) different plants.   

At each study location, market quality potato samples were cultivated
using both untreated control and treated test plots.  Each treated test
plot received a single application made at the maximum labeled rate of
250 g ai/ha timed so that early, mid and late seasonal treatments could
be evaluated.  This treatment program also included field testing the
application of the VENTURE L and FUSILADE MAXX fluazifop-p-butyl end-use
products using side-by-side test plots.  This comparison was only made
for treatments those timed at the early seasonal application interval as
a means for providing bridging data on these EC formulations.  The
actual rate of application ranged from 92.5% to 103.6% of the targeted
amount of product designated for treatment.  The application procedure
followed was typical of the local agricultural practices with treatments
being made using either tractor-mounted or hand-held boom sprayers.  No
adjuvant was added to the spray mixture for any of the applications.    
 

For the determination of total fluazifop residues in/on potatoes, an
acceptable method was used and adequate data are available to support
the sample storage durations of up 142 days that were incurred.  Total
residue levels were all observed to be at or below the LOQ (0.010 ppm)
for treatments made at early seasonal timed PHIs (89-90 days) using both
fluazifop formulations.  In conjunction, residue levels for mid-seasonal
timed PHIs (60-61 days) were found to range from 0.024- 0.130 ppm and
late-seasonal timed PHIs (46 days) at 0.065- 0.170 ppm.  In all, these
data are adequate to support the proposed seasonal use pattern on
potatoes put forward in this study.  A summary of the residue data
obtained from the potato field trials made for this study are presented
below in Table 8 for review.

Table 8.      Residue Data from Crop Field Trials with Fluazifop-P-butyl
Presented in MRID No. 47920403.

Trial:  City, Province; Year

(Trial ID #)	Zone	Potato; Variety	# of Treatments	 Total Rate 

(g ai/ha)	PHI 1

 (days)	End-Use Product	Total

Fluazifop

(ppm)

Hunter River, PEI; 2007 (T232)	1A	Russet Burbank	1	250	90	Venture L	<
LOD2, <LOD

Fusilade Maxx	< LOD, <LOD

	60	Venture L	0.042, 0.038

	46	Venture L	0.065, 0.072

Hunter River, PEI; 2007 (T233)	1A	Yukon Gold	1	250	90	Venture L	< LOD,
<LOD

Fusilade Maxx	< LOD, <LOD

	60	Venture L	0.13, 0.11

	46	Venture L	0.093, 0.085

Portage la Prairie, MB; 2007 (T234)	5	Burbank	1	250	89	Venture L	< LOD,
<LOD

Fusilade Maxx	0.0048, <LOD

	61	Venture L	0.024, 0.024

	46	Venture L	0.17, 0.14

1  PHI = Preharvest interval; interval from last application to harvest
(petitioner reported PHI based on collection date).

2  LOD = Limit of Detection; 0.0033 ppm.

Conclusions:  The submitted residue data made for potato tubers are
adequate in fulfilling these data requirements.  The number and location
of field trials were in line with the Canadian regulatory requirements. 
To satisfy the Canadian requirement for a total of 16 trials in all, the
results from two studies were compiled to provide a complete data
submission.  MRID No. 47920402 contains 13 field trials and MRID No.
47920403 provides an additional 3 more made on the premise of a bridging
study for showing the equivalency of Venture L and Fusilade Maxx EC
formulations.  In regard to this comparison, this bridging data along
with the supplemental information in the CSF summary of each end-use
product adequately demonstrate these end-use products to be equivalent. 
Nonetheless, the trials which were made appropriately reflect the
proposed use pattern, and supporting storage stability data are
available.  The residue data compiled for the potato RAC 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 regulatory level (Appendix I).  The resulting
spreadsheet provides a best estimate of a tolerance which is determined
to be 1.0 ppm for the potato RAC.

860.1520 Processed Food and Feed

DER References:  47920405.der.doc (potato)

		

For this action, Syngenta is requesting the establishment of a new
import tolerance for residues of fluazifop-P-butyl in/on potatoes and
its processed commodities.  To satisfy data requirements, the registrant
has submitted a processing study made for this herbicide ai on potatoes.
 A summary of the data acquired from this processing study is presented
below in Table 9.

TABLE C.3.	Residue Data from Potato Processing Study with
Fluazifop-P-butyl.

Trial: City, State; Year (Trial ID#)	Processed Commodity	Total Rate

(g ai/ha) 	PHI 

(days)	Residues (ppm)	Processing Factor1

Büchen, Germany; 1993 (B2)	Potato RAC (w/peel)	375	42	0.22	--

	Potato Peel

	0.25	1.1x

	Cooked Potato

	0.32	1.4x

	Potato Chips

	0.72	3.3x

	Dried Potato

	1.41	6.4x

1  The processing factor was calculated by the study reviewer by
dividing the residues in the processed sample by the residues in the
unprocessed RAC sample. 

Potato (MRID No. 47920405)

The field portion of this study was carried out by ZENECA AGRO based in
Frankfurt using six (6) field trials held at separate sites within
Germany to cultivate potatoes during the 1993 growing season.  No
details concerning the varieties of potatoes that were grown, the use of
any maintenance pesticides and fertilizers, soil chemistry, weather
data, or the use of supplemental irrigation was provided.  The data
submission only noted that each test location received an application of
the Fusilade end-use product formulation of fluazifop-P-butyl applied at
a late seasonal Pre-Harvest Interval (PHI) of six weeks.  These
treatments were made at the targeted amount of 375 g ai/ha in order to
provide each test plot with a total seasonal application that was
equivalent to 1.5x the maximum labeled use rate.  For this program, the
field samples from the two trials observed with the highest residues of
total fluazifop were processed into potato peels, cooked potatoes, chips
and dried flakes for testing.  

For this study, the cultivation of market quality potato samples was
made using individual untreated control and treated test plots.  The
collected potato samples were shipped chilled at temperatures of 4-6° C
via common carrier to the laboratory of DR. SPECHT & PARTNER (Hamburg,
Germany) for processing.  In doing so, this study would clarify how
residues of fluazifop which may be present in harvested potatoes degrade
or concentrate when processed by typical household preparation methods. 
For these purposes, the samples from the Bienenbüttel-Varendorf and
Büchen trials with the highest observed residues of total fluazifop
were processed.  All samples were stored frozen at the laboratory until
processing which was initiated a week after harvest.  Representative
mixed samples were formed and processing was then carried out according
to laboratory SOP# Q-51.037.02 in order to simulate normal domestic
preparation procedures.  The potato processing procedure was as follows
(MRID No. 447920405):

Cooked Potatoes

About 2 Kg of peeled potatoes were covered with 2 L of water and brought
to a boil after the addition of 10 g of common salt.  The potatoes were
cooked for 20–25 minutes and then drained with the cooking liquid kept
separately.  	

Chips

About 2 Kg of peeled potatoes were cut into slices.  Approximately 1 Kg
of fat was heated in a deep-frying-pan, and fried for 20 minutes.

Dried Potatoes 

About 1.5 Kg of peeled potatoes were sliced, distributed evenly on the
racks of the desiccation apparatus and dried at level 3 for 6–8 hours.

Freezing 

The processed potatoes were frozen prior to analysis.  Before freezing
cooked potatoes were homogenized, chips and dried potatoes were chopped
coarsely.

Sample storage conditions and durations are summarized in Table C.2. 
Based upon the information provided, the approximate maximum storage
duration of the potato samples from harvest/processing to analysis did
not exceed 200 days (≈6.7 months) for the study.  To support the
storage interval of the samples collected for this study, the stability
of fluazifop-P-butyl in frozen potatoes has previously been investigated
in prior reports generated by Syngenta.  These reports show that
fortified potatoes demonstrate no loss of fluazifop-p-butyl when stored
frozen at -18°C for 18 months (DP No. D348246, D. Soderberg,
09/16/2008).  However, storage stability data are required to support
the storage conditions and durations of the processed commodities.

The results in this data submission provide a determination of residue
concentration factors for fluazifop-P-butyl in potato processed
commodities.  It was appropriately carried out in line with the
recommendations set forth in the OPPTS 860.1520 Residue Chemistry Test
Guidelines for evaluating the concentration of residues in processed
commodities.  Processing of the potato RAC bearing quantifiable residues
of fluazifop resulted in no concentration of residues in the peel (1.1x
processing factor).  However, total fluazifop residues were found to
concentrate in potato chips and dried flakes at a processing factor of
3.3x, and 6.4x, respectively.  In all, these data are adequate for
determining residue concentration factors for potato processed
commodities.  

Conclusions.  The potato processing results acquired in this study are
adequate for satisfying these data requirements.  These results indicate
that total fluazifop residues do not appear to concentrate in the potato
peels, but may do so in the chips and granules/flakes processed
fractions.  Residues of total fluazifop were therefore found to
concentrate in potato chips and granules/flakes at processing factors of
3.3x and 6.4x, respectively.  Based on the HAFT residue for potato (0.55
ppm) and these processing factors, expected residues are 1.81 ppm in
chips and 3.52 ppm for granules/flakes.  In comparison, the expected
residues of these processed fractions are greater then the 1.0 ppm
recommended tolerance for potato.  Potato tolerances of 2.0 ppm in chips
and 4.0 ppm for granules/flakes are thus recommended with no limits in
peels being required.     

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

Analytical standards for fluazifop-p-butyl and fluazifop-p (resolved (R)
isomer of fluazifop acid) are currently available in the EPA National
Pesticide Standards Repository.  The fluazifop-p-butyl standard expires
1/1/2011.  Analytical reference standards must be replenished as
requested by the Repository.  The reference standards should be sent to
the Analytical Chemistry Lab, which is located at Fort Meade, to the
attention of either Theresa Cole or Thuy Nguyen 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.)

860.1850/860.1900 Confined and Field Accumulation in Rotational Crops

The following plantback restriction exists on the product label (EPA
Reg. No. 100-1070):  a 60-day plantback interval for rotational crops
such as corn, sorghum, and cereals.    SEQ CHAPTER \h \r 1 This
plantback interval is also appropriate for sugar beet. 

860.1550 Proposed Tolerances

In a meeting on March 3, 2004, the MARC concluded that for tolerance
expression, parent and fluazifop-acid (free and conjugated) are the
residues of concern since they are adequate to determine misuse (DP No.
D298939, S. L. Kinard, 06/22/2004).  An acceptable soybean metabolism
study is available along with new studies made to a root crop and leafy
vegetable which are currently undergoing Agency review.  In accordance,
tolerances are established under 40 CFR §180.411(a)(1) and (c)(1) for
residues of fluazifop-butyl, including free and conjugated fluazifop,
expressed as fluazifop.  For fluazifop-P-butyl, including free and
conjugated fluazifop (R isomer), tolerances are likewise established
under 40 CFR §180.411(a)(2) and (c)(2) with residues expressed as
fluazifop.  Its registered uses include asparagus, carrot, coffee,
cotton, endive (escarole), garlic, macadamia nut, onion, pecan, pepper,
rhubarb, soybeans, stone fruits, sweet potato, and yam.  It also carries
a registration for use on lawns as a weed control application. 
Subsequently, a petition for establishing tolerance limits on dry beans
and peanuts is currently pending.  

For this action, field trials on potatoes along with a corresponding
study made on its pertinent processed commodities were submitted to
support this petition request.  In evaluating the field trials provided
by the registrant, these studies were found to be adequate in satisfying
these residue chemistry data requirements.  Total fluazifop residues
in/on the potato RAC were found to be readily quantifiable at levels
greater then the LOQ of the test method.  In accordance, the Agency’s
Guidance for Setting Pesticide Tolerances Based on Field Trial Data was
utilized for determining appropriate tolerance levels for potato tubers
(Appendix I).  Based on these calculations, the proposed potato
tolerance of 0.25 in roots is adequate and a limit of 1.0 ppm for tops
is recommended.  In regard to the corresponding processing study data
that were provided, it can be concluded that no additional tolerances
are needed for the peel.  However, residues of fluazifop were found to
concentrate in potato chips (3.3x) and dried flakes (6.4x).  Based on
the potato HAFT of 0.55 ppm and the processing factors calculated for
chips and dried flakes, expected residues in these fractions are 1.82
ppm and 3.52 ppm, respectively.  As a result, the tolerances of 2.0 ppm
in chips and 4.0 ppm for dried flakes are recommended for these potato
processed commodities.

The proposed new uses included in this petition will request the
establishment of tolerances on potato crops which are commonly
recognized as being livestock feedstuffs.  Given that these uses will be
established on imported commodities, residues of fluazifop-P-butyl in/on
potatoes will not result in being a contributor to the dietary burden of
cattle.  In accordance, it will not be necessary to provide a
re-calculation of dietary burden in support of this action.  The
conclusions determined for the secondary transfer of fluazifop-P-butyl
residues to meat, milk, poultry, and eggs made prior for the pending
uses established on dry beans and peanuts remain current.

The established tolerances for livestock commodities are 0.05 ppm for
total fluazifop residues in milk and the meat and meat byproducts of
cattle, goat, hog, horse, and sheep, and fat, meat and meat byproducts
of poultry.  These levels remain appropriate. 

In all, the available residue data provided for fluazifop-P-butyl are
adequate to support the establishment of new import tolerance levels
recommended for the potato RACs proposed in this action.  There are no
Codex or Mexican established Maximum Residue Limits (MRLs) for residues
of fluazifop-P-butyl in/on potatoes.  However, this petition is being
put forward as a request for the establishment of import tolerances on
potato commodities which will be cultivated in Canada.  There are no
established MRLs for residues of fluazifop-P-butyl in/on potatoes in
Canada but the promulgation of regulatory levels by PMRA are in the
process of being finalized.  As a result, international harmonization
with Canada is a consideration for this data evaluation concerning the
establishment of tolerances on imported potato commodities.  The
proposed limits should therefore be revised and a new Section F
submitted to reflect the recommended tolerance levels and correct
commodity definitions specified below in Table 8.

Table 8. 	Tolerance Summary for Fluazifop-P-butyl.

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

Tolerances Proposed for 40 CFR §180.411(a)(1)

Potato, tubers	--	1.1	1.0	Potato

Potato, chips	--	3.0	2.0

	Potato, granules/flakes	--	5.0	4.0

	References

DP No.:	D319907

Subject:	Fluazifop-P-butyl.  REVISED TRED – Report on FQPA Tolerance
Reassessment Progress and Interim Risk Management Decisions.  Residue
Chemistry Considerations.  Case No. 2285.

From:		S. L. Kinard

To:		D. Locke

Dated:		08/17/2005

MRID Nos.:	00093840-1, 00093843, 00093845, 00137763, 00144014, 00151494,
00157191, 001517193, 40140401, 40241901, 40341601, 40361104, 40361108,
40361111, 40693108, 40725701, 40831303-5, 40831307, 40831309-10,
41018001, 41373703.

DP No.:	D298939

Subject:	Fluazifop-P-butyl.  Report of the Metabolism Assessment Review
Committee. 

From:		S. L. Kinard

To:		Y. Donovan

Dated:		03/17/2004

MRIDs:	None

DP No.:	D348246

Subject:	Fluazifop-P-Butyl. Section 3 Registration Request to Add New
Uses on Beans (Dry), Peanuts and Soybeans. Summary of Analytical
Chemistry and Residue Data.

From:		D. Soderberg

To:		J. Miller

Dated:		9/16/2008

MRID Nos.:	47285501-05; 46412503

  SEQ CHAPTER \h \r 1 Attachments:  

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

Template Version September 2005

International Residue Limits 

Fluazifop-P-butyl (122809; 08/26/2010)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US	Canada	Mexico2	Codex3

40 CFR 180.411:

Plant/Livestock: 
butyl(R)-2-[4-[[5-(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate,
and the free and conjugated forms of the resolved isomer of fluazifop,
(R)-2-[4-[[5-(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoic acid,
expressed as fluazifop.

	butyl (RS)-2-[4-[[5-(trifluoromethyl-2-pyridinyl]oxy]phenoxy]propanoate

(calculated as acid)

None

Commodity1	Tolerance (ppm) /Maximum Residue Limit (mg/kg)

	US	Canada	Mexico2	Codex

Potato, tubers	1.0	None

None

Potato, chips	2.0

	Potato, granules/flakes	4.0

	Completed: M. Negussie/08/30/2010

1 Includes only commodities of interest for this action.  Tolerance
values should be the HED recommendations and not those proposed by the
applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment,
such as treatment of stored grains.  PoP = processed postharvest treated
commodity, such as processing of treated stored wheat. (fat) = to be
measured on the fat portion of the sample. MRLs indicated as proposed
have not been finalized by the CCPR and the CAC.

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.

Potato, tubers

The dataset used to establish a tolerance for fluazifop-P-butyl on
potatoes consisted of field trial data representing application of the
VENTURE L end-use product made at the maximum labeled rate of 250 g
ai/ha with a 45 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 used to calculate the tolerance are provided in Table I-1.

Most of the 32 field trial sample results were above the LOQ (LOQ = 0.01
ppm).  The fluazifop-P-butyl-dry potato dataset was 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 log normality should not be rejected.

Since the field trial data for fluazifop-P-butyl on potato represent a
large dataset (i.e., more than 15 samples) and are reasonably lognormal,
the minimum of the 95% upper confidence limit (UCL) on the 95th
percentile and the point estimate of the 99th percentile should be
selected as the tolerance value.  Using the rounding procedure as
outlined in the Guidance for Setting Pesticide Tolerances Based on Field
Trial Data SOP, the 95% UCL on the 95th percentile rounds to the value
0.80 ppm.  For the use, the recommended tolerance level for potato
tubers is 1.0 ppm based upon this minimum value found in the UCL of the
95th percentile. 

 

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Figure I-   SEQ Figure_II- \* ARABIC  1 .  Lognormal probability plot of
fluazifop-P-butyl field trial data for potatoesbean.

Figure I- 2.   Tolerance spreadsheet summary of fluazifop-P-butyl field
trial data for potatoes.

 

Page   PAGE  23  of   NUMPAGES  23 

Fluazifop-P-butyl	Summary of Analytical Chemistry and Residue Data	DP
No. 372408

Fluazifop-P-butyl	Summary of Analytical Chemistry and Residue Data	DP
No. 372408